advertisement
cobas® 8000 modular analyzer series
Operator’s Manual
Software Version 05-01
cobas® 8000 modular analyzer series
Document information
Document version
1.0
2.0
3.0
4.0
4.0.1
4.0.2
4.1
4.2
4.2.1
Table 1
Software version
01-01
Revision date Changes
Jun. 2009
03-01
04-01
04-01
04-01
04-02
05-01
05-01
Oct. 2010
Apr. 2013
May 2013
June 2013
Nov. 2013
Oct. 2014
May 2015 cobas e 602 module added cobas c 702 module added o
General update including, by way of example: o
New software features such as review of calibrator status, PT link, rack unloading, change rack priority, reagent pack masking o
Revised software features such as download of applications, calibrators and controls
Hitergent was replaced by Ecotergent
Manual cleaning revised
Cleaning of pipetter probes revised o o
Changed ISE measuring ranges
Use of different tubes on a rack o
Other changes and corrections
New software features added u
What is new in software version 05-01?
Caution message revised. Devices emitting electromagnetic fields can now be operated in the same room with the instrument.
Revision history
Edition notice This Operator’s Manual is for users of the cobas® 8000 modular analyzer series.
The cobas® 8000 modular analyzer series is composed of two main components: o
The cobas® 8000 instrument includes the analytical modules, the control unit, and other core components.
o
The cobas® 8000 data manager consists of a PC which coordinates data in real time between the instrument and the laboratory LIS.
u
A separate Operator’s Manual is available for the cobas® 8000 data manager.
Every effort has been made to ensure that all the information contained in this document is correct at the time of printing. However, Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development.
Any customer modification to the instrument will render the warranty or service agreement null and void.
Intended use The cobas® 8000 modular analyzer series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Roche Diagnostics
2 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
The cobas® 8000 modular analyzer series is an in-vitro diagnostic (IVD) medical equipment.
It is important that the user reads the Operator's Manual thoroughly before using the cobas® 8000 modular analyzer series.
Copyright © 2009–2014, Roche Diagnostics GmbH. All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS C, COBAS INTEGRA, ELECSYS and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
System approvals The cobas® 8000 modular analyzer series meets the protection requirements specified in IVD Directive 98/79/EC.
Compliance is demonstrated by the following mark:
The cobas® 8000 instrument and data manager comply with
IVD directive 98/79/EC.
The Operator's Manual meets the requirements of the DIN EN ISO 18113-3 standard.
Instrument approvals Furthermore, the cobas® 8000 instrument is manufactured and tested according to the following international safety standards: o
IEC 61010-1: 2001 o
IEC 61010-2-081: 2001 and A1 o
IEC 61010-2-101: 2002 o
UL 61010-1 2nd Ed.
o
CAN/CSA C22.2 No. 61010-1: 2nd Ed. Jul. 12, 2004; Oct. 28, 2008 o
CAN/CSA C22.2 No. 61010-2-101: 04 o
CAN/CSA C22.2 No. 61010-2-081: 04
Issued by Intertek for Canada and the US.
The cobas® 8000 instrument complies with the emission and immunity requirements described in standard IEC 61326-2-6:2005.
Roche Diagnostics
Operator’s Manual · 4.2.1
3
cobas® 8000 modular analyzer series
Contact addresses
Inside the European Union and
EFTA member states:
Manufacturer of cobas® 8000 instrument
Manufacturer of cobas® 8000 data manager
Authorized representative
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shinbashi
Minato-ku, Tokyo 105-8717
Japan
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Outside the European Union and
EFTA member states:
Manufactured by:
Manufactured for:
Hitachi High-Technologies Corporation
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Roche Diagnostics
4 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
8000 modular analyzer series
Videos in the Online Help of the instrument
Online Help of the data manager
Conventions used in this document
What is new in software version 05-01?
System description
Safety labels on the instrument
Safety information for barcode readers
3 Core components of the system
link platform and functions
75
Sample containers, racks and trays
9
Operation instrument
218
222
10 Safety information for operation
Safety messages (overall system)
ISE module)
Safety messages (photometric modules)
602 modules)
The help system of the instrument
Software design and functionality
231
233
Roche Diagnostics
Operator’s Manual · 4.2.1
5
cobas® 8000 modular analyzer series
Maintenance
cobas ISE module)
cobas c 701 module)
cobas c 702 module)
cobas c 502 module)
cobas e 602 module)
cobas ISE module)
Calibration (photometric modules)
cobas e 602 module)
435
445
336
345
358
381
394
Preparing DVD media for backups
Archiving data and performing data backups 504
19 Safety information for maintenance
Safety messages (overall system)
ISE module)
Safety messages (photometric modules)
602 module)
Combined maintenance schedules (all
Background and parallel maintenance 624
21 Maintenance of the core unit
Maintenance schedule for the core unit
22 Maintenance of cobas ISE module
cobas ISE module 645
23 Maintenance of photometric modules
Maintenance schedule for photometric modules 691
582
584
Roche Diagnostics
6 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
24 Maintenance of cobas e 602 module
Maintenance schedule for the cobas e
602 module 763
Troubleshooting
ISE module)
Data alarms (photometric modules)
823
602 module)
845
cobas ISE module)
Troubleshooting (photometric modules)
cobas e 602 module)
884
897
Glossary
Index
Revisions
Roche Diagnostics
Operator’s Manual · 4.2.1
7
cobas® 8000 modular analyzer series
Roche Diagnostics
8 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
About the cobas 8000 modular analyzer series
The cobas 8000 modular analyzer series is a fully automated system for qualitative and quantitative in vitro diagnostics, providing a wide variety of tests. The cobas 8000 modular analyzer series is a powerful tool for complete diagnostic laboratory automation. The system is optimized for high throughput workloads. The ion selective electrode ( cobas ISE module), the photometric analysis ( cobas c 701, c 702 and c 502 modules), and the immunoassay analysis ( cobas e 602 module) allow a large variety of tests within one system.
The cobas 8000 data manager implements management functionality for data and workflow. The data manager acts as an interface with the cobas 8000 instrument, the laboratory information system (LIS), and the Roche TeleService Net (TSN). Through the TeleService Net it enables access to, and routing of remote information and functionality to and from Roche. It provides enhanced sample tracking, test management, result traceability, storage and reporting, together with quality control management. Additionally, it has LIS backup functionality and serves as a robust storage location for the instruments attached.
7KHFREDVPRGXODUDQDO\]HUVHULHV
FREDVGDWDPDQDJHU
FREDVLQVWUXPHQW
Figure 1 The cobas 8000 modular analyzer series
Roche Diagnostics
Operator’s Manual · 4.2.1
9
cobas® 8000 modular analyzer series
Where to find information
The following documents assist you in finding desired information quickly:
This Operator's Manual Describes operation, maintenance and troubleshooting of the cobas® 8000 instrument and the other components of the cobas® 8000 modular analyzer series. An index at the end of the manual help you to find information quickly. A glossary offers detailed explanations for selected key words.
q Observe the Operator's Manual for safe operation of the instrument o If the instrument is used in a manner not specified in the Operator's Manual, the protection provided by the instrument may be impaired.
o Keep this manual in a safe place to ensure that it remains easily accessible at all times.
Operator’s Manual of the cobas® 8000 data manager
Contains information for operation and configuration of the cobas® 8000 data manager.
Online Help The software of the cobas 8000 instrument and the cobas® 8000 data manager both offer context-sensitive help features.
Context-sensitive means that the help system always displays information related to the current window or software element. Therefore, both help systems offer a quick and convenient way to find information.
u
For more information, see:
Online Help of the instrument (p. 11)
Online Help of the data manager (p. 11)
COBI CD The COBI CD (Compendium of Background Information) provides you with background information about the technologies, test principles, their theory and calibration methods used by the cobas 8000 instrument. q Adobe Acrobat Reader is needed to view the content of the COBI CD. Adobe Acrobat
Reader is not installed on the control unit and must not be installed. Therefore, you cannot run the COBI CD on the control unit of the instrument.
Customer information
Customer training Contact your local Roche sales representative for any questions or information regarding training on the cobas 8000 modular analyzer series.
Contact customer service Contact your local Roche service representative for further information regarding a service agreement for the cobas 8000 modular analyzer series.
Ordering information Replacement parts, consumable materials, reagents, calibrators and controls should be ordered from Roche Diagnostics. When ordering, please use the Roche
Diagnostics catalog number and reference name for each item. Contact Roche technical support for the detailed ordering list.
Roche Diagnostics
10 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Online Help of the instrument
The user interface of the cobas 8000 instrument has a context-sensitive online help system to support you in operating the instrument. The help system describes each element available in the instrument software, from Operator to Administrator level.
The instrument software offers two help features: o
F1 Help and o
Direct Help.
F1 Help : This help feature displays information related to the current window . Use the
F1 Help feature if you require detailed information about this window. Hypertext links guide you to additional information and procedures related to this window.
q The Operator's Manual is included in the F1 Help system. This allows you to search for information throughout the software reference and the manual. All cross-references are implemented as hyperlinks.
u
For more information on F1 Help, see:
Searching for information in the help system (p. 253)
Direct Help : This help feature displays brief information related to a single software element, such as a button or text box. Use this help feature if you only require a tooltip about an element.
u
For more information on Direct Help, see
Videos in the Online Help of the instrument
The Online Help is equipped with a number of video clips which show different maintenance tasks. q The video clips are only available if the instrument is in Standby.
u
For a list of the included videos, see
List of maintenance videos (p. 630).
Online Help of the data manager
The data manager application also provides a context-sensitive online help system.
The help appears in a dedicated window.
You display help in context by pressing [F1].
Selecting DM help on the Help menu opens the help window at its table of contents.
Additionally, the Online Help provides an index, and search and bookmarking functionality.
Roche Diagnostics
Operator’s Manual · 4.2.1
11
cobas® 8000 modular analyzer series
Conventions used in this document
Visual cues are used to help locate and interpret information in this document quickly. This section explains formatting conventions used in this document.
Symbols The following symbols are used:
Symbol Used for
Safety alert symbol
Q
P
S o
U l
Table 2
Tip
Start of procedure
End of procedure
List item
Cross-reference
Cross-reference for information provided in the Online Help of the instrument.
This function is applicable, or this action must be performed.
The check mark is sometimes used as a link to the corresponding topic.
Electrical and electronic equipment marked with this symbol are covered by the European directive WEEE.
The symbol denotes that the equipment must not be disposed of in the municipal waste system.
Symbols used in this document
Abbreviations The following abbreviations are used:
Abbreviation
0–9
5
6
7
A
Abs
ACN
ANSI
ASCII
AU1, AU2, …
B
B1, B2, …
BC
Table 3
Definition c 502 module (used in the user interface only) e 602 module c 701/ c 702 module
Absorbance
Application Code Number
American National Standards Institute
American Standard Code for Information Interchange
Analytical Unit 1, 2, … (used in the user interface only)
Module Sample Buffer 1, 2, … (used on the Overview menu only)
Barcode
Abbreviations
Roche Diagnostics
12 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Roche Diagnostics
Operator’s Manual · 4.2.1
Abbreviation
CSA
CSF
CV
CU
D
DAT dB(A)
C c module c 701 c 702 c 502 c7-1, c7-2, c7-3
Cal., CAL
CC
C.E.
CE
CFAS
Ch.
CLAS clinchem
COBI CD
Definition photometric module ( cobas c cobas c cobas c
Calibration
Carryover Evasion
European Conformity marking
Calibrator For Automated Systems
Channel (measuring channels 1 and 2 on
Clinical Laboratory Automation System
Clinical chemistry
Compendium Of Background Information
Canadian Standards Association
CerebroSpinal Fluid
Coefficient of Variation (%)
Core Unit c 701 / c 702 / c 502)
701 module for photometric assays
702 module for photometric assays
502 module for photometric assays
First, second, third c 701 / c 702 module of the instrument
CleanCell, an auxiliary reagent used on the e e 602 module
602 modules)
DCCT/NGSP
EDTA e.g.
ELISA
EMC
EMF
EN
F
FBT
DIL
DM
E e 602 e6-1, e6-2, e6-3
EC
ECL
ECO-D
G
GS
GUI
Table 3
Drugs of Abuse Testing
Decibel weighted against the A-frequency response curve. This curve approximates the audible range of the human ear.
Diabetes Control and Complications Trials / National
Glycohemoglobin Standardization Program
Diluent
Data Manager cobas e 602 module for immunoassay analysis
First, second, third e 602 module of the instrument
European Community electrochemiluminescence, a technology used by e 602 modules
Ecotergent ethylene diamine tetra-acetate exempli gratia – for example
Enzyme-linked Immunosorbent Assay
ElectroMagnetic Compatibility
ElectroMotive Force
European standard
False Bottom Tube
Gepruefte Sicherheit – tested safety, a German safety marking
Graphical User Interface
Abbreviations
13
Roche Diagnostics
14 cobas® 8000 modular analyzer series
L
LED
LIS
LLD
LSS
M
M
MPA
MSB
MSDS
N n/a
P
P
NaCl
NAOH-D
PC
PC/CC
PRE
PSM
Table 3
Abbreviation
ISO
IVD
IVDD
K
KCL kVA
I
ICVC
ID i.e.
IEC
IFCC
IS
ISE
H
HbA1c
HCG
HIS
HL7
HPI
I
Definition
Hemoglobin A1c, glycosylated hemoglobin
Human Chorionic Gonadotropin
Hospital information system
Health Level 7, a network protocol
High-Priority Immunoassay
ISE module (used in the user interface only)
Initial Cassette Volume Check
Identification id est – that is to say
International Electrical Commission
International Federation of Clinical Chemistry
Internal Standard (for ISE module)
Ion Selective Electrode; also used for ISE module
International Organization for Standardization
In Vitro Diagnostic
In Vitro Diagnostic Directive potassium chloride, reference solution for ISE module kilovolt-Ampere. Unit used for the apparent power in alternating current (AC) electrical circuits
Light-emitting diode, a semiconductor light source
Laboratory Information System
Liquid Level Detection
Liquid Short Sensor
Reagent Manager (used in the Reagent menu only)
MODULAR PRE-ANALYTICS , a laboratory automation solution, to which the cobas 8000 instrument can be connected to
Module Sample Buffer
Material Safety Data Sheet not applicable sodium chloride sodium hydroxide detergent
Photometric module
Personal Computer (the control unit)
ProCell / CleanCell, auxiliary reagents used on the e 602 module
Pretreatment reagent for immunoassays
Process System Manager (a software)
Abbreviations
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Abbreviation
SCCS
SD
SIP
SMS
SPR
STAT
Std
SU
Q
QC
R
R1/R2/R3
RCM
RD
Reac.
REF
RFID
RIA
R.P. or R. pack
RMr
RRM
S
SB
Definition
Quality Control
Pipetting time points of reagents; also refers to the respective reagents
Reaction Calculation Module
Roche Diagnostics
Reaction bath temperature (used on the Overview menu only)
Reference solution for ISE module
Radio Frequency Identification
Radioimmunoassay
Reagent pack
Reagent Manager (used in the user interface only)
Rack Reception Mode
StandBy
Special Cell Cleaning Solution
Standard Deviation
ISE sipper syringe
Detergent for special washes of reagent probes
Special Reagent
Short Turn-Around Time
Standard, commonly used for calibrator rack Sampler Unit, the rack loading / unloading area
(SU is used on the Overview menu)
T
TDM
TORCH
TPA
TSN
U
UL
W
WAM
WEEE
Wi-Fi
Table 3
Therapeutic Drug Monitoring
Toxoplasmosis, Other perinatal infections, Rubella,
Cytomegalovirus, Herpes simplex virus tripropylamine
TeleService Net
Underwriters Laboratories Inc.
Work Area Manager (a middleware software)
European Waste Electrical and Electronic Equipment Directive
Wireless Fidelity, synonym for wireless local area network
Abbreviations
Product names Except where the context clearly indicates otherwise, this manual uses the following descriptions:
Roche Diagnostics
Operator’s Manual · 4.2.1
15
cobas® 8000 modular analyzer series
Product name Description cobas® 8000 modular analyzer series system (includes instrument and data manager) cobas® 8000 instrument instrument (includes analytical modules and control unit) cobas® 8000 data manager cobas ISE module cobas c 701 module cobas c 702 module cobas c 502 module cobas e 602 module
Table 4 Product names data manager
ISE module c c c e
701 module
702 module
502 module
602 module
What is new in software version 05-01?
This section provides an overview of all major changes in this software version.
This version requires Windows 7 on the control unit, Windows XP is not supported.
Mixing sample types and container types on a rack
You can consolidate different sample types and container types on a single rack.
Sample consolidation can be useful, for example, if the instrument is connected with a CLAS. The CLAS can use the same rack range for pre-processing of different samples types.
On the Standard tab of the Rack Assignment window, you must define a rack range for the sample type None to consolidate samples. The information about the sample type and in some cases also the information about the container type is sent via HL7 protocol to the control unit.
u
See: Mixing sample types and container types on a rack (p. 510)
Reagent registration by maintenance pipe
You can include registration of reagents in a maintenance pipe. Then new reagents are registered on c 701/ c 702 modules and the maintenance item (27) Inventory
Update is performed on e 602 modules.
If you execute a maintenance pipe with this option, you do not need to register new reagents manually. After returning from Manual Cleaning mode, the required reagent registration can be executed by a maintenance pipe. If the reagent registration was already performed before, it is skipped in the maintenance pipe. u
See: Defining and editing maintenance pipes (p. 596)
Overwriting editable parameters when updating an application
When you download an updated application from the data manager, you can now select between Overwrite and Partial Overwrite : o
To download the application with all new settings, choose Overwrite .
o
To keep the settings of all user-editable parameters, choose Partial Overwrite .
In previous software versions, user-editable parameters were not updated when you downloaded an updated application from the data manager.
u
See: Updating applications (p. 541)
Roche Diagnostics
16 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Turnaround time for racks The new Loading Rack Limit allows you to configure the amount of racks loaded onto the system. By limiting the number of racks in the system by reducing this setting, you can decrease the amount of rack traffic in the system. As a result, there is more time for rack unloading to occur.
Unloading and exchanging of racks requires free slots on the module sample buffers.
By default, two of the 20 slots of each MSB are reserved for rack exchange. However, when more racks are on the loader, two slots may be insufficient and racks cannot be unloaded in time. This may lead to a reduced throughput.
In previous software versions, rack loading was not limited. In some cases, this lead to increased rack transfers and rack traffic in the system, allowing processed racks to resided in the MSB for a longer period of time.
u
Integration of ISE data alarms If the ISE noise error (ISE.N) or ISE voltage level error (ISE.E) data alarms are detected during an ISE measurement, the results of the two other ISE tests for this sample may also be effected. Therefore, the ISE.N or ISE.E data alarm is attached to all ISE test results for this sample. The ISE.N data alarm takes priority over ISE.E.
Separate check limits for slope and calibrator S3 concentration
For ISE calibrations, the software now uses two separate compensated limit checks: If the slope differs by more than the Compensated Limit set under Utility
> Application > Calib.
from previous calibrations, the Cal.E alarm occurs. In addition, the S3 concentration is checked by applying a separate limit. This limit is the Compensated Limit multiplied by a fixed factor of 0.25. If this check fails, the
Cal.E alarm is also issued.
Example: If the Compensated Limit is set to 10%, the S3 concentration will be checked by applying a limit of (10 x 0.25 =) 2.5%.
In previous software versions, a common compensated limit for slope and S3 concentration was used.
Downloading and updating parameters
The user rights for downloading application, calibrator, control, and special wash parameters are re-organized: o
Supervisors may download parameters for the newest and current release of an already installed application/calibrator lot/control lot.
For special wash parameters, supervisors may download the newest and current release of the same wash type and module type.
o
Administrators may select the release to be downloaded and may install new parameters.
u
See:
Downloading application parameters (p. 538)
Installing calibrators (p. 429)
Installing special wash parameters (p. 572)
New ISE calibration scheme ISE compensator is replaced by ISE Standard high (S3).
u
See: Calibration (cobas ISE module) (p. 435)
Roche Diagnostics
Operator’s Manual · 4.2.1
17
cobas® 8000 modular analyzer series
Roche Diagnostics
18 Operator’s Manual · 4.2.1
System description
cobas® 8000 modular analyzer series
Table of contents
General safety information
1 General safety information
1
Before you start working with the cobas 8000 system, it is essential that the warnings, cautions, and safety requirements contained in this manual, as well as the explanations of the safety labels to be found on the system are read and understood by the user.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
1
Instrument unused for a long period of time.......................................................33
21
1 General safety information
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
22 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety classifications
Safety classifications
WARNING
CAUTION
NOTICE
This section explains how precautionary information is presented in this manual.
The safety precautions and important user notes are classified according to the
ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:
Safety alert symbol r The safety alert symbol by itself (without a signal word) is used to promote awareness to hazards which are generic. It is also used to direct the reader to safety information provided elsewhere in the document.
These symbols and signal words are used for specific hazards:
WARNING r Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION r Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
NOTICE r Indicates a hazardous situation which, if not avoided, may result in property damage.
The following symbol indicates important information which is not safety relevant: q Tip
Indicates additional information on correct use of the system or useful tips.
Roche Diagnostics
Operator’s Manual · 4.2.1
23
1 General safety information
Safety precautions
Safety precautions
cobas® 8000 modular analyzer series
Particular attention r Pay particular attention to the following safety precautions. If you ignore these safety precautions, you may suffer serious or fatal injury. Each precaution is important.
Operator qualification
Operators are required to have a sound knowledge of relevant guidelines and standards as well as the information and procedures contained in the Operator's
Manual.
o
Do not carry out operation and maintenance unless you have been trained by
Roche. o
Carefully follow the procedures specified in the Operator's Manual for the operation and maintenance of the system. o
Leave maintenance, installation or service that is not described in the Operator's
Manual to trained Roche service personnel. o
Follow standard laboratory practices, especially when working with biohazardous material.
Safe and proper use of the instrument
Keep in mind that the hazard warnings in this manual and on the instrument cannot cover every possible case, as it is impossible to predict and evaluate all circumstances beforehand.
Just following the given directions therefore may be inadequate for operation. Always be alert and use your common sense.
Personal protective equipment o
Before performing routine operation or any maintenance, be sure to wear appropriate protective equipment, including, but not limited to, safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves. o
Wear a face shield if there is a chance of splash or splatter.
Accuracy/precision of measured results
An incorrect result may lead to an error in diagnosis, therefore posing danger to the patient.
o
For proper use of the instrument, measure control samples and monitor the instrument during operation.
o
Do not use reagents, calibrators, or quality controls that have exceeded their expiration dates. Observe the specified storage conditions. Otherwise, inaccurate results may be obtained.
o
For diagnostic purposes always assess the results in conjunction with the patient's medical history, clinical examination and other findings.
Installation o
Installation must be performed by trained Roche service personnel only. o
Leave installation that is not described in the Operator's Manual to trained Roche service personnel. Follow the described installation instructions carefully.
Roche Diagnostics
24 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety precautions
Operating conditions o
Operation outside of the specified ranges may lead to incorrect results or
malfunction of the instrument (see Specifications (p. 205)). Never modify the
instrument.
o
Use the instrument indoors only and avoid heat and humidity.
o
Make sure that the instrument's ventilation openings remain unobstructed at all times.
o
Perform maintenance according to the specified intervals to maintain the operating conditions of the instrument.
o
Keep the Operator’s Manual in a safe place to ensure that it is not damaged and remains available for use. This manual must be easily accessible at all times.
Handling of reagents and other working solutions o
Reagents, calibrators and controls must be handled, stored and disposed of according to the instructions given in the Instructions for Use.
o
Samples and chemicals must be handled, stored and disposed of on your own responsibility and in accordance with the appropriate standards.
Approved parts Use of non-approved parts or devices may result in malfunction of the instrument and may render the warranty null and void. Only use parts and devices approved by
Roche.
Third-party software Installation of any third-party software that is not approved by Roche may result in incorrect behavior of the instrument. Do not install any non-approved software. Do not install a commercially available program into the control unit computer or change any PC settings.
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage or aging of the hard disk may damage the instrument or lead to data loss. Perform backups of measurement results periodically. Operate only with an uninterruptible power supply.
Do not switch off power while the PC accesses the hard disk or another storage medium.
Computer viruses If you register an unexpected operation or program/data damage, the PC may be infected by a computer virus. Never use a program or storage medium that is suspected of containing a virus. Before using a removable storage medium, it should be scanned by an antivirus program.
Instrument unused for an extended period of time
If the instrument is not used for an extended period of time, the main power must be switched OFF. Remove, close, and refrigerate any remaining reagents. For further information, call technical support.
u
For more information, see also:
Instrument unused for a long period of time (p. 33)
Extended power OFF and ON procedures (p. 801)
Relocation and transportation Do not attempt to relocate or transport the instrument. Leave relocation and transportation to personnel trained or authorized by Roche.
u
For information about disposal of the instrument, see:
Disposal of the instrument (p. 52)
Roche Diagnostics
Operator’s Manual · 4.2.1
25
1 General safety information
Safety summary
Safety summary
cobas® 8000 modular analyzer series
This safety summary contains the most important and general warning and caution messages. Additionally, you will find specific safety information at the beginning of the parts: o
o
The following figure shows the available modules of the cobas 8000 instrument:
A
A Core unit
B ISE module
Figure 1-1
B C D C E C F
C Module sample buffer
D c 702 module
E c 502 module
F e 602 module
Modules of the cobas 8000 instrument (the control unit and the c 702 module are not shown in this figure) u
For more information about the system components, see:
Overview system components (p. 53)
Warning messages
WARNING
List of warning messages
Failure to observe warning messages may result in death or serious injury.
r Before operating the instrument, read the warning messages contained in this summary carefully.
Roche Diagnostics
26 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Electrical safety
WARNING
1 General safety information
Safety summary
Electrical shock from electronic equipment
Removing covers marked with the high voltage sign ( ) can cause electric shock, as there are high voltage parts inside. In addition, opening the top cover of a photometric module ( c 701 / c 702 or c 502) and touching the ultrasonic mixing mechanism during operation can also cause electric shock.
r Do not attempt to work in any electronic compartment.
r Do not remove any cover of the instrument other than those specified in the Operator's
Manual.
r Do not open the top cover of a photometric module and touch the ultrasonic mixing unit during operation or when the instrument performs maintenance.
r Installation, service, and repair must only be performed by personnel authorized and qualified by Roche.
r Observe in particular the following safety labels on the instrument:
Biohazardous materials
WARNING
WARNING
Infection from samples and associated materials
Contact with samples containing material of human origin may result in infection. All materials and mechanical components associated with samples of human origin are potentially biohazardous.
r Follow standard laboratory practices, especially when working with biohazardous material.
r Keep all covers closed and in place while the instrument is operating. r When working with open top cover while the instrument is powered on (e.g., for cleaning or maintenance), always put the instrument in an appropriate mode first.
r Be sure to wear appropriate protective equipment, including, but not limited to, safety glasses with side shields, fluid resistant lab coat, and approved disposable gloves. r Wear a face shield if there is a chance of splash or splatter.
r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If sample or waste solution comes into contact with your skin, wash it off immediately with soap and water and apply a disinfectant. Consult a physician.
r Observe in particular the following safety labels on the instrument:
T-1 (p. 38), T-8 (p. 38), T-11 (p. 38);
Infection and injury due to sharp objects r When wiping probes and sippers, use several layers of gauze and wipe from the top down.
o Be careful to not puncture yourself.
o Be sure to wear appropriate protective equipment, for example gloves. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.
Roche Diagnostics
Operator’s Manual · 4.2.1
27
1 General safety information
Safety summary cobas® 8000 modular analyzer series
Reagents and other working solutions
WARNING
Skin inflammation or injury caused by reagents and other working solutions
Direct contact with reagents, detergents, cleaning solutions, or other working solutions may cause skin irritation, inflammation, or burns.
r When handling reagents, exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as goggles, gloves). r Observe the cautions given in the Instructions for Use and observe the information given in the Material Safety Data Sheets available for Roche reagents and cleaning solutions. r Be careful when removing open reagent packs from the instrument. They may contain residues of reagents.
r On the c 702 module: Empty the cap waste box periodically. Do not let its contents overflow or reagent spill over.
r If a reagent, detergent or other working solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
r
Observe in particular the following safety label on the instrument: F-7 (p. 41).
Waste
WARNING
Infection from waste solution and solid waste
Since waste solution contains patient samples, contact with waste solution and solid waste
(e.g., reaction cells, ISE electrodes, AssayCups, AssayTips) may result in infection. All materials and mechanical components associated with the waste systems are potentially biohazardous. r Be sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut which can lead to infection. r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
r Observe in particular the following safety labels on the instrument:
Waste must be treated in accordance with the relevant laws and regulations. Any substances contained in reagents, calibrators, and quality controls, which are legally regulated for environmental protection, must be disposed of according to the relevant water discharge facility regulations. For the legal regulations on water discharge, please contact the reagent supplier.
Roche Diagnostics
28 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
WARNING
1 General safety information
Safety summary
Two kinds of liquid waste are discharged by the instrument: o
Concentrated waste solution that contains highly concentrated reaction solution.
This waste must be treated as infectious waste as specified by the relevant local regulations.
o
Dilute waste: A non-concentrated waste solution diluted with rinsing water from cell wash or water from the incubator bath. When using NaOH-D for washing the reaction cells, alkaline concentration is 0.1 to 1.0 mmol/L in terms of sodium hydroxide equivalence. Dilute waste is discarded through tubes at the rear of the instrument.
Contamination of the environment due to inappropriate treatment of waste
All materials that have come into contact with human blood or blood products are potentially biohazardous.
r Therefore liquid waste and replacement parts such as reaction cells and ISE electrodes have to be treated as infectious medical waste.
r When disposing of any waste generated by the instrument, do so according to the relevant laws and local regulations.
q Pipeline or containers for liquid waste o Depending on the local regulations, the outlets for diluted waste can be connected to the drain pipe. The outlets for concentrated waste of all modules are usually connected to a waste pipeline for infectious medical waste.
Exception: The concentrated waste solution from the ISE module is collected in a container.
o If a waste pipeline is not available in the building, waste containers for liquid waste are optionally available for all modules.
u
Please contact your Roche service representative for more information.
Roche Diagnostics
Operator’s Manual · 4.2.1
29
1 General safety information
Safety summary
Caution messages
cobas® 8000 modular analyzer series
CAUTION
List of caution messages
Failure to observe caution messages may result in minor or moderate injury.
r Before operating the instrument, read the caution messages contained in this summary carefully.
Mechanical safety
CAUTION
Personal injury due to contact with moving parts r Keep all covers closed and in place while the instrument is operating. r When working with open top cover while the instrument is powered on (e.g., for cleaning or maintenance), always put the instrument in an appropriate mode first.
r Only trained personnel should have access to the keys to the protective covers of the instrument.
r Do not touch any parts of the instrument other than those specified. Keep away from moving parts during instrument operation.
r Do not remove the covers of the rack conveyor lines.
r Only load or unload racks when the green status LEDs at the rack loading area are on.
r During operation and maintenance of the instrument, proceed according to the instructions.
r Observe in particular the following safety labels on the instrument:
F-2 (p. 41), F-5 (p. 41), F-9 (p. 41);
Reagents and other working solutions
CAUTION
Incorrect results due to incorrect reagent volume
Application faults may cause an undetectable loss of reagent.
r Do not reuse a reagent pack whose reagent has been spilled.
r Do not use a single reagent pack for different instruments.
CAUTION
CAUTION
Incorrect results due to inappropriate storage conditions
Reagents, auxiliary reagents, calibrators, and controls are sensitive regarding temperature and/or light, especially if the container is already open.
r Always store reagents, auxiliary reagents, calibrators, and controls according to the storage conditions specified in the Instructions for Use.
Incorrect results due to insufficient reagent volume
When using cobas c pack MULTI, it must be filled with the exact filling volume specified in the Instructions for Use. If this is not the case, measurement accuracy may deteriorate.
Additionally, an alarm (reagent short) may occur if the instrument detects that the reagent volume is low. r Ensure that the cobas c pack MULTI contains the correct filling volume. Refer to the
Instructions for Use.
Roche Diagnostics
30 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety summary
Insoluble contaminants in samples
CAUTION
Incorrect results and interruption of analysis due to contaminated samples
Insoluble contaminants in samples may cause clogging or pipetting volume shortage and lead to deterioration in measurement accuracy. r When loading samples on the instrument, make sure that samples contain no insoluble contaminants such as fibrin or dust.
r Ensure to prepare enough sample volume for measurement.
Foam or films on samples or reagents
CAUTION
Incorrect results due to incorrect pipetting volume
Foam or films on samples or inside reagent containers may cause pipetting volume shortage and lead to deterioration in measurement accuracy.
r When loading samples, calibrators and controls on the instrument, make sure that they do not contain any foam, bubbles or films.
r Avoid the formation of foam with all reagent types.
Evaporation of samples or reagents
CAUTION
Incorrect results due to evaporation of samples or reagents
Evaporation of samples or reagents may lead to incorrect results. For critical analytes in terms of on board time, you must safeguard a short turn-around time.
r Do not expose samples, calibrators, or quality controls that have been pipetted into a sample container to open air for any length of time.
r To obtain information about the turn-around time, evaluate the scanning time in the
Data Review submenu and the result calculation time in the Monitor window.
r Do not use expired reagents. Do not leave reagents on the instrument for a prolonged period of time.
Cross contamination of samples
CAUTION
Incorrect results due to carryover
Traces of analytes or reagents may be carried over from one test to the next. r Take adequate measures to safeguard additional testing and to avoid potentially false results.
u
For more information about avoiding carryover and cross-contamination between
tests, see Special Wash submenu (p. 564).
Roche Diagnostics
Operator’s Manual · 4.2.1
31
1 General safety information
Safety summary
Data security
CAUTION cobas® 8000 modular analyzer series
Unauthorized access and data loss due to malicious software and hacker attacks
Portable storage media can be infected with and transmit computer malware, which may be used to gain unauthorized access to data or cause unwanted changes to software.
The cobas 8000 modular analyzer series is not protected against malicious software and hacker attacks.
The customers are responsible for IT security of their IT infrastructure and for protecting it against malicious software and hacker attacks. Failure to do so may result in data loss or render the cobas 8000 modular analyzer series unusable.
r Roche recommends the following precautions: o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security equipment. Roche strongly recommends the use of a cobas IT Firewall.
o Do not copy or install any software on the cobas 8000 modular analyzer series unless it is part of the system software or you are instructed to do so by a Roche service representative. o If additional software is required, contact your Roche service representative to ensure validation of the software in question. o Do not use the USB ports to connect other storage devices unless you are instructed to do so by official user documentation or a Roche service representative.
o Exercise utmost care when using external storage devices such as CDs, or DVDs.
Do not use them on public or home computers while connecting to the cobas 8000 modular analyzer series.
o Keep all external storage devices in a secure place and ensure that they can be accessed by authorized persons only.
Electromagnetic devices
CAUTION
Malfunction of instrument and incorrect results due to interfering electromagnetic fields
This instrument has been designed and tested to IEC 61326-2-6. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference.
r The electromagnetic environment should be evaluated prior to operation of the device.
r Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not operate this instrument in close proximity to sources of strong electromagnetic fields (for example unshielded intentional radio frequency (RF) sources).
r Do not operate the following devices in close proximity to the instrument: o Mobile phones o Transceiver o Cordless phones o Other electrical devices that generate strong electromagnetic fields
Roche Diagnostics
32 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety summary
Instrument unused for a long period of time
If the instrument is not used for a long period of time, the main power must be switched OFF. Remove, close and refrigerate any remaining reagents. For further information, call technical support.
CAUTION
Incorrect results after longtime power off
If the instrument has been powered off for a week or more, accuracy may deteriorate.
r Check the instrument performance before starting up operation again. For performance check details, consult your local service representative.
r For e 602 modules, additionally follow the procedures described in this manual.
u
See
Extended power OFF and ON procedures (p. 801)
Fatigue due to long hours of operation
CAUTION
Fatigue due to long hours of operation
Looking at the monitor screen over an extended period of time may lead to eye strain or body fatigue. r Take a break for 10 to 15 minutes every hour to relax. r Avoid spending more than 6 hours per day looking at the monitor screen.
Spillage
CAUTION
Malfunction due to spilled liquid
Any liquid spilled on the instrument may result in malfunction, or damage of the instrument.
r Do not place samples, reagents or any other liquid on the surface of the instrument.
r If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
Notices
NOTICE List of notices r Before operating the instrument, read the notices contained in this summary carefully.
Failure to observe them may result in damage to equipment.
Moving parts
NOTICE Damage to the instrument due to contact with moving parts
Contact with moving parts may bend the probes or damage some other component. If the instrument detects a collision, an alarm will be issued and operation will be stopped immediately.
r Keep all covers closed and in place while the instrument is operating.
r Do not touch any parts of the instrument other than those specified. Keep away from moving parts during instrument operation.
r Only load or unload racks when the green status LEDs at the rack loading area are on.
Roche Diagnostics
Operator’s Manual · 4.2.1
33
1 General safety information
Safety summary cobas® 8000 modular analyzer series
Powering-on and starting analysis
NOTICE Damage to the instrument due to contact with moving parts
If you power-on the instrument or start an analysis run while maintenance is under way, parts or tools may come into contact with the mechanism and damage the instrument.
r Make sure no maintenance item or check is being performed when powering on the instrument or starting analysis.
Cleaning solvents
NOTICE Damage to the instrument due to the use of organic solvents for cleaning
Organic solvents may dissolve surfaces of the instrument.
r Do not use any organic solvents except for isopropyl alcohol or ethanol.
Circuit breakers and fuses
NOTICE Damage to the instrument due to improper use r Should one of the instrument circuit breakers or fuses blow, do not attempt to operate the instrument before contacting either your Roche service representative or technical support.
Roche Diagnostics
34 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety labels on the instrument
Safety labels on the instrument
Warning labels have been placed on the instrument to draw your attention to areas of potential hazard. The labels and their definitions are listed below according to their location on the instrument. The safety labels on the instrument comply with the following standards: ANSI Z535, IEC 61010, IEC 60417, or ISO 7000.
q If the labels are damaged, they must be replaced by Roche service personnel. For replacement labels, contact your local Roche representative.
Label descriptions
Spillage warning
This label indicates that the instrument may be damaged if a spillage occurs within the vicinity of this label.
Do not place liquids in this area.
Infection warning
This label indicates that touching the instrument mechanism can cause infection or injury to your fingers or hands.
Do not open this cover while the instrument is in operation. Stop every mechanism, then open the cover.
Protective equipment warning
This label indicates that there is a danger of coming into contact with corrosive material within the vicinity of this label.
Wear appropriate protective equipment (such as goggles and gloves).
Warning
This label indicates that there is a danger of hazardous situations arising within the vicinity of this label, which may result in death or serious injury.
Refer to the Operator's Manual for instructions on safe operation.
Biohazard warning
This label indicates that there are potential biohazards within the vicinity of this label.
Follow standard laboratory practices for working with biohazardous materials.
Electrical warning
This label indicates that there is a danger of coming into contact with electrical components when gaining access to parts of the instrument marked with this label.
Refer to the Operator's Manual for instructions on safe operation.
Hot surface warning
This label indicates that the area within the vicinity of this label may be hot.
Do not touch this area as you may be burned.
Roche Diagnostics
Operator’s Manual · 4.2.1
35
1 General safety information
Safety labels on the instrument
2 kg Max.
cobas® 8000 modular analyzer series
Maximum weight ( c 502 only)
This label indicates the maximum weight.
Do not place anything heavier than the specified weight on the label.
Mechanical parts warning ( e 602 only)
This label indicates there is a danger of coming into contact with moving mechanical parts within the vicinity of this label.
Keep your hands away from this area.
Mechanical parts warning ( e 602 only)
This label indicates there is a danger of coming into contact with sharp objects which may result in slight or minor injuries.
Keep your hands away from this area.
Roche Diagnostics
36 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Top view – ISE and photometric modules
T-1 T-2 T-1
1 General safety information
Safety labels on the instrument
T-3
T-2
T-4
T-1
T-5 T-6 T-7
T-2 T-10
T-8
T-9
T-9
Figure 1-2
T-7 T-7
T-8 T-9 T-11 T-12
Top view of the modules (top row: Core, ISE and c 702; bottom row: c 701 and c 502)
T-13
Roche Diagnostics
Operator’s Manual · 4.2.1
2 kg Max.
T-14
37
1 General safety information
Safety labels on the instrument
T-1
T-2
T-3
T-4
T-5
T-6
T-7
T-8
T-9
T-10
T-11
T-12
T-13
T-14
2 kg Max.
cobas® 8000 modular analyzer series
Warning: Possibility of infection or injury due to contact with operating mechanisms!
Keep covers closed whenever possible.
Spilled liquids, e.g. water or detergents, may cause instrument damage.
Wipe up spilled liquids immediately.
Attention to the maximum load of the transfer mechanism for reagent packs
Do not lean on the transfer mechanism especially during maintenance.
Caution: Measurement accuracy may be reduced if an ISE cover is opened during analysis or if liquid remains inside!
Keep ISE covers closed during analysis. Wipe up liquid from inside the ISE compartment after maintenance.
Observe direction when loading reagent packs at the c 702 loading port!
Observe position when loading reagent packs at the c 702 loading port!
Observe direction when loading racks at the module sample buffer!
Warning: Possibility of electrical shock inside the instrument
Do not remove this cover.
Warning: Possibility of burning yourself on the lamp or the lamp housing when replacing the photometer lamp!
Wait until the lamp housing has cooled down.
For the c 502 module: The label is placed below the reaction disk.
Caution against pinch by pipetting mechanism!
Do not touch any moving parts when loading racks at the backup operation port.
Warning: Possibility of infection due to contact with mechanisms!
Follow standard laboratory practices for working with biohazardous materials.
Warning: Possibility of injury due to contact with mechanisms!
Observe direction when loading reagent packs at the c 502 module!
Attention to maximum load of the cassette table
Do not place anything other than reagent packs upon the table.
Roche Diagnostics
38 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Top view – cobas e 602 module
T-14
1 General safety information
Safety labels on the instrument
T-15 T-16 T-17
Roche Diagnostics
Operator’s Manual · 4.2.1
T-17
T-18
T-19
Figure 1-3
T-2
T-14
T-15
T-16
T-18 T-19
Top view of the e 602 module
T-2
Spilled liquids, e.g. detergents or water, may cause instrument damage.
Wipe up spilled liquids immediately.
Caution against injury due to contact with the reagent disk
Keep the reagent disk cover closed whenever possible.
Caution: Your fingers may get caught by the gripper
Keep your hands away from the gripper area when top cover is open.
Warning: Possibility of infection due to contact with samples
Caution against injury due to contact with the mechanism
Return the incubator cover after performing maintenance.
Notice: Aluminum parts may be damaged!
Do not use acid or alkaline solutions to clean aluminum parts.
Caution against injury due to contact with the sample probe
Keep your hands away from the sample probe area when top cover is open.
Caution: Measurement accuracy may be reduced if the reagent disk cover is opened!
Keep the reagent disk cover closed during analysis.
Warning: Possibility of infection due to contact with mechanical parts
Follow standard laboratory practices for working with biohazardous materials.
39
1 General safety information
Safety labels on the instrument
Front view – ISE and photometric modules
F-1 F-2 cobas® 8000 modular analyzer series
F-2
F-3 F-4 F-5
F-2
F-5
F-1 F-8
F-6 F-7
F-9
Figure 1-4
Roche Diagnostics
40
F-5 F-6 F-7 F-5 F-6 F-10
Front view of the modules (top row: Core, ISE and c 702; bottom row: c 701 and c 502)
F-5 F-7
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F-1
F-2
F-3
F-4
F-5
F-8
F-9
F-6
F-7
F-10
1 General safety information
Safety labels on the instrument
Attention to interlock!
Do not open this cover during operation. If it is opened, operation will be interrupted immediately and all parts below this cover will be switched off.
Warning: Possibility of infection or injury due to contact with operating mechanisms!
Keep covers closed whenever possible.
Caution: Touching the ISE drain ports during analysis may lower measurement precision!
Keep the front doors closed during operation.
Warning: Possibility of infection due to contact with ISE drain ports!
Warning: Fingers or skin may be pinched by syringe (when plunger is moving).
Do not touch any moving parts.
Caution: Loose tube connector may lower measurement precision.
After performing maintenance, tighten connector securely.
Warning: Possibility of infection due to contact with waste from the vacuum tank!
Caution: Detergent and/or reagent may cause skin irritation!
Observe safety precautions. Wear protective equipment.
Caution against contact with the reagent pipetter and piercer
Do not touch any moving parts.
Caution against contact with the loading mechanism for reagent packs!
Do not touch any moving parts.
Warning: Possibility of infection due to contact with sipper syringe!
Follow standard laboratory practices for working with biohazardous materials.
Roche Diagnostics
Operator’s Manual · 4.2.1
41
1 General safety information
Safety labels on the instrument
Front view – cobas e 602 module
F-11
F-7 F-12 cobas® 8000 modular analyzer series
F-13
Figure 1-5
F-14 F-7
Front view of the e 602 module
F-15 F-16
F-5
F-7
F-7
F-11
F-5 F-15
Warning: Fingers or skin may be pinched by syringe (when plunger is moving).
Do not touch any moving parts.
Caution: Detergent and/or reagent may cause skin irritation!
Observe safety precautions. Wear protective equipment.
Attention to the status of the green illuminated push buttons!
Replace the bottle only when the green light is flashing.
F-12
F-13
Warning: Possibility of infection and injury due to contact with mechanical parts
Keep the top cover closed whenever possible.
Attention to handling the magazine drawer!
Open the magazine drawer only when the green status lamp is
ON. Do not put excessive weights on the magazine drawer.
Roche Diagnostics
42 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F-14
F-15
F-16
Side view – complete instrument
1 General safety information
Safety labels on the instrument
Warning: Possibility of infection due to contact with used
AssayTips and AssayCups!
Follow standard laboratory practices for working with biohazardous materials.
Caution: Incorrect results due to misplaced reagents
Observe correct positions when replacing reagents. Only replace a bottle if the green push button is flashing.
Caution against injury due to contact with PreClean needles!
Do not put your hands into the PreClean bottle holder.
S-1
Roche Diagnostics
Operator’s Manual · 4.2.1
S-2
Figure 1-6
S-1
S-2
S-3
S-3
Left view of the instrument (example combination)
Observe rack direction when loading racks at the STAT port!
Caution: Water may leak from water tanks
Before disconnecting the joint, close the tap at the water tank.
Warning: Possibility of infection due to contact with concentrated waste solution from the waste container!
Follow standard laboratory practices for working with biohazardous materials.
43
1 General safety information
Safety labels on the instrument
Rear view – ISE and photometric modules
R-1 R-2 R-3 cobas® 8000 modular analyzer series
R-3 R-4
R-5
R-3
R-6 R-7
R-1
R-8
R-2
R-7
R-3
Figure 1-7
Roche Diagnostics
44
R-5 R-6 R-7 R-5 R-6
Rear view of the modules (top row: Core, ISE and c 702; bottom row: c 701 and c 502)
R-7
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
R-1
R-2
R-3
R-4
R-5
R-6
R-7
R-8
1 General safety information
Safety labels on the instrument
Warning: Possibility of infection or injury due to contact with operating mechanisms!
Keep covers closed whenever possible.
Attention to interlock!
Do not open the plexiglass cover (below the back cover) during operation. If it is opened, operation will be interrupted immediately and all parts below this cover will be switched off.
Warning: Possibility of infection or injury due to contact with samples on racks!
Do not remove these covers when the instrument is powered on!
Warning: Loss of sight caused by intense light of laser barcode reader
Do not stare into the beam of the laser barcode reader.
Warning: Possibility of infection due to contact with waste solution!
Follow standard laboratory practices for working with biohazardous materials.
Caution: Incorrect results due to loose tube connectors
Follow all instructions for water inlet filter maintenance carefully!
Warning: Possibility of electrical shock
Do not remove these covers!
Warning: Possibility of infection due to contact with ISE waste solution!
Follow standard laboratory practices for working with biohazardous materials.
Roche Diagnostics
Operator’s Manual · 4.2.1
45
1 General safety information
Safety labels on the instrument
Rear view – cobas e 602 module
R-3 cobas® 8000 modular analyzer series
Roche Diagnostics
46
R-6
R-7
Figure 1-8
R-3
R-5
R-5 R-6
Rear view of the e 602 module
R-7
Warning: Possibility of infection or injury due to contact with samples on racks!
Do not remove these covers when the instrument is powered on!
Warning: Possibility of infection due to contact with waste solution!
Follow standard laboratory practices for working with biohazardous materials.
Caution: Incorrect results due to loose tube connectors
Follow all instructions for water inlet filter maintenance carefully!
Warning: Possibility of electrical shock
Do not remove these covers!
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety information for barcode readers
Safety information for barcode readers
WARNING
The cobas 8000 instrument uses barcode readers to scan the barcodes on samples and racks. o
Most of the barcode readers use LED technology with very low output power.
o
One laser barcode reader is used in the core unit. The laser beam is fully covered during normal operation.
The cobas 8000 instrument complies with the lowest laser class (Class 1) as long as the laser barcode reader is covered. However, the following safety message must be observed.
Loss of sight caused by intense light of barcode readers
The intense light of a laser or LED barcode reader may severely damage your eyes or result in hazardous radiation exposure.
r Do not stare into the beam of a laser or LED barcode reader.
r Do not remove covers from barcode readers. Do not perform any maintenance actions on barcode readers. If problems concerning the barcode readers occur, contact your local technical support.
r The use of controls or adjustments or the performance of procedures other than those specified herein may result in hazardous radiation exposure.
Roche Diagnostics
Operator’s Manual · 4.2.1
47
1 General safety information
Safety information for barcode readers
Laser barcode reader
cobas® 8000 modular analyzer series
The cobas 8000 core unit is a class 1 laser product (which is the lowest class). The beam of the incorporated class 2 laser is protected from possible viewing so that the core unit itself is a class 1 product.
The mentioned classes refer to the standard IEC 60825-1: o
Class 1: Eye-safe under normal operating conditions.
o
Class 2: Visible lasers. Eye-safe for accidental viewing. However, it may not be safe for a person who deliberately stares into the laser beam for longer than 0.25 s, by overcoming their natural aversion response to the very bright light.
The following figure shows the position of the laser barcode reader and the directions of its apertures in the cobas 8000 instrument:
BC-1
Figure 1-9 Localization of barcode readers – Core unit, ISE module, c 702 and c 502 module
No.
BC-1
Table 1-1
Module
Core
Wavelength Pulse width and pulse frequency
Output power Max. output of laser diode
10 mW 660 nm 112 μ s
8.93 kHz
1.0 mW
Laser barcode reader in the cobas 8000 instrument
Remark
Class 2 laser
IEC 60825-1, +A2:2001
Roche Diagnostics
48 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Safety information for barcode readers
LED barcode readers
BC-2 BC-3
The following two figures show the position of the LED barcode readers (Class 1) and the directions of their apertures in the cobas 8000 instrument:
BC-4 BC-5 BC-6 BC-7 BC-8
Figure 1-10 Localization of barcode readers – Core unit, ISE module, c 702 and c 502 module
No.
BC-2
BC-3
BC-4
BC-5
BC-6
BC-7
BC-8
Table 1-2
Module Wavelength Output power
Core
ISE c 702 MSB c 702
655 nm
655 nm
655 nm
655 nm
10 μ W
10 μ W
10 μ W
10 μ W c 502 MSB c 502
655 nm
655 nm
10 μ W
10 μ W c 502 655 nm 10 μ W
LED barcode readers – Core unit, ISE module, c 702 and c 502 module
BC-9 BC-10 BC-11 BC-12 BC-13
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 1-11
No.
BC-9
BC-10
BC-11
BC-12
BC-13
Table 1-3
Localization of barcode readers – c 701 and e 602 module
Module c 701 MSB c 701 e 602 MSB
Wavelength
655 nm
655 nm
655 nm e 602 e 602
655 nm
655 nm
LED barcode readers – c 701 and e 602 module
Output power
10 μ W
10 μ W
10 μ W
102.92 μ W
10 μ W
49
1 General safety information
Interlock function
Interlock function
cobas® 8000 modular analyzer series
Several covers of the instrument are equipped with an interlock function to protect you from being injured by fast moving parts. Two different types of interlock are used in the cobas 8000 instrument: o
Electronic interlock (used in various covers) o
Mechanical interlock (used in c 702 top cover)
Electronic interlock (various covers)
A
CAUTION
If one of these covers is opened, the interlock function immediately switches all moving parts below this cover to a currentless status.
Interrupt of operation due to interlock system
The interlock system senses opening of the monitored covers and immediately stops operation by cutting off the power. All pipetted samples are lost and must be reloaded.
r Before starting operation or a software-controlled maintenance item, be sure to close and lock all covers. Operation will not start if an interlock cover is open.
r Do not open an interlock cover during operation or maintenance. Mask the module first to put it in Standby.
r Observe in particular the following safety labels on the instrument:
ISE and c 502:
c 701 / c 702:
The following covers are monitored by the interlock function: o
ISE module: Top cover o c 701 / c 702 modules: Rear plexiglass cover around the sample probes o c 502 module: Top cover
B C
A ISE - Top cover
Figure 1-12
B c 701 / c 702 - Rear plexiglass cover C c 502 - Top cover
Covers that are monitored by the interlock function o
If you open one of these covers during maintenance (such as Incubator Bath
Cleaning mode), this status is terminated. After closing the cover again, the status changes to Standby .
o
If you open one of these covers during operation , the instrument performs an emergency stop. The monitor displays a red alarm (Stop). Perform the following procedure to put the instrument back to Standby.
Roche Diagnostics
50 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 1 General safety information
Interlock function p To put the instrument to Standby after an emergency stop by interlock
1 Close and lock the cover that is monitored by the interlock function.
2 If an alarm about an unlocked cover is issued, delete this alarm.
3 Choose Utility > Maintenance > (1) Reset .
4 Choose Select to open the Reset window.
5 Select the module to be reset and choose Execute .
q Always execute a reset after using the interlock release tool ( c 502 module). When it is possible that mechanisms have been moved, always execute a reset to return them to their home positions.
s
Mechanical interlock (c 702 top cover)
The top cover of the c 702 module is provided with a mechanical interlock. When starting operation, the instrument automatically locks the top cover if it is closed. If the top cover is open at the beginning of operation, the instrument cannot lock it and will issue an alarm without starting operation. In Standby mode, the reagent manager may only load a reagent pack if the top cover is closed.
A
WARNING
A c 702 top cover
Figure 1-13 c 702 top cover – mechanically locked
Infection and injury when the top cover is open (c 702 only)
Contact with the reagent pack transfer mechanism or other mechanisms of the c 702 module may result in personal injury or infection. Therefore, the top cover is locked when the transfer mechanism moves.
r Before opening the c 702 top cover while the module is in Standby, check the
Reagent Manager Overview window to make sure that there are no reagent packs inside the buffer rotor of the reagent manager.
r Keep the top cover closed whenever possible. Otherwise, reagent packs cannot be loaded.
r Before starting operation or any software-controlled maintenance, be sure to close the top cover of the c 702 module. Otherwise operation would not start.
Roche Diagnostics
Operator’s Manual · 4.2.1
51
1 General safety information
Disposal of the instrument
Disposal of the instrument
WARNING cobas® 8000 modular analyzer series
Infection by a potentially biohazardous instrument
The instrument must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal of the instrument.
r Dispose of the instrument according to the appropriate local regulations. For more information, contact your Roche representative.
Disposal of control unit components
Components of your control unit and data manager PC (such as the computer, monitor, keyboard) which are marked with this symbol are covered by the European Directive on
Waste Electrical and Electronic Equipment (WEEE, 2002/96/EC).
r These items must be disposed of via designated collection facilities appointed by government or local authorities.
For more information about disposal of your old product, please contact your city office, waste disposal service or your Roche representative.
r Constraint:
It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat them in the same way as the instrument.
Roche Diagnostics
52 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Overview system components
2 Overview system components
2
This chapter provides an overview of all system components of the cobas 8000 modular analyzer series.
In this chapter
Chapter
2
Roche Diagnostics
Operator’s Manual · 4.2.1
53
2 Overview system components
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
54 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 2 Overview system components
Overview
Overview
cobas 8000 system The cobas 8000 modular analyzer series is a system for in vitro analysis. This system is built up by combination of hardware- and software components: o cobas 8000 data manager - software o cobas 8000 instrument
A B
A cobas 8000 data manager PC
Figure 2-1
B cobas
The cobas 8000 modular analyzer series
8000 instrument cobas 8000 instrument The cobas 8000 instrument consists of: o
Control unit o
Core unit o
ISE module (optional) o
Up to four instrument modules
A
A cobas 8000 control unit PC
B
B cobas 8000 instrument modules and core components
Figure 2-2 The cobas 8000 instrument
The cobas 8000 instrument hardware is a set of minimum one and maximum four individual instrument modules, a core unit, and an ISE module.
u
For more information about the instrument hardware, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
55
2 Overview system components
Overview cobas® 8000 modular analyzer series cobas 8000 basic structure The following figure presents a schematic overview of the basic structure of the cobas 8000 modular analyzer series. The control unit PC is directly placed beside the instrument. The data manager PC can be placed close beside the instrument, or, depending on the laboratory workflow needs, somewhere else.
GDWDPDQDJHU
VRIWZDUH
FRQWUROXQLW
VRIWZDUH
FREDVLQVWUXPHQWPRGXOHV
KDUGZDUH
0 0 0 0
Figure 2-3 The cobas 8000 modular analyzer series - a schematic overview with instrument modules M1 to M4
The cobas 8000 modular analyzer series is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. It is designed for both, quantitative and qualitative in vitro determinations using a large variety of tests for analysis.
It is ready to operate 24 hours per day. The cobas 8000 modular analyzer series: o
Consists of modules controlled by a control unit PC o
Has a core unit with a loading area and unloading area for up to 300 samples each o
Has an independent module sample buffer for each module with random access o
Has environmental controlled compartments to extend on-board lifetime of reagents and auto QCs o
Has an ISE module with two individual ISE units that allow ion-selective electrode measurements and an independent sampling line for up to
1800 tests / hour o
Is controlled by a data manager that allows seamless integration into the laboratory workflow o
Performs in vitro quantitative and qualitative tests on a wide range of analytes o
Performs photometric assays on cobas c 701 / c 702 / c 502 modules o
Performs electrochemiluminescence assays on the cobas e 602 module
Roche Diagnostics
56 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 2 Overview system components
Software components
Software components
The software components of the cobas 8000 modular analyzer series are: o
Software of the cobas 8000 data manager o cobas 8000 instrument software o cobas e-services and cobas link
All software components use a graphical user interface (GUI) in order to allow userfriendly control of all functions by the operator.
Data manager software
The data manager software is directly communicating with the local LIS and the control unit of the cobas 8000 instrument.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 2-4 The data manager PC - example installation and software GUI
The data manager software is a command /control center between the cobas 8000 instrument and an LIS.
As part of the laboratory workflow, the data manager coordinates data in real time between the cobas 8000 instrument and the LIS of the laboratory.
The data manager offers several benefits: o
Processes patient demographics, orders, results o
Offers independent QC data management including graphical presentation o
Can be adapted to local requirements of QC standards and rules o
Allows centralized result flag tracking of all instrument modules o
Provides online e-services o
More efficient implementation of new requirements and software upgrades
57
2 Overview system components
Software components cobas® 8000 modular analyzer series
Total system layout The following illustration gives a brief overview concerning the total system layout:
+,6 /,6 '0 ,QVWUXPHQW
A B C
A HIS - Hospital Information System
B LIS - Laboratory Information System
Figure 2-5
C
D
DM - data manager
Instrument - a set of modules
The cobas 8000 modular analyzer series - as part of the laboratory communication
D
Component tasks These are the main tasks of the components presented above: o
The HIS is the central data base system which traces patient data and makes them available for the LIS system.
o
The LIS performs order and result processing. It sends patient orders to the cobas 8000 modular analyzer series, receives related results, and, after validation, makes these data available throughout a hospital.
o
The DM receives orders by the LIS. It controls sample- and QC results of the instrument.
Data distribution on the system While the cobas 8000 modular analyzer series is a complex system, it is important for the operator to know where to find which information.
The chart given below shall help to give a broad orientation of the type of data being processed and their distribution:
HVHUYLFHV
/,6
5HVXOWV
‡&DO
‡4&
‡6DPSOH
2UGHUV
'0
5HVXOWV
‡&DO
‡4&
‡6DPSOH
2UGHUV
,QVWUXPHQW
Figure 2-6 Data distribution of the cobas 8000 modular analyzer series
Online exchange of the cobas e-services, applications for calibrators and controls ensure the up to date download of new application data and / or updates of current applications.
Roche Diagnostics
58 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Instrument software
2 Overview system components
Software components
The cobas 8000 instrument software on the control unit keeps control of all instrument modules which are installed. This software communicates directly with the data manager software.
The software uses a graphical user interface (GUI) that supports you running the cobas 8000 instrument.
Figure 2-7 Control unit PC - example installation and software GUI
Roche Diagnostics
Operator’s Manual · 4.2.1
59
2 Overview system components
Software components
cobas link and the cobas e-library
cobas® 8000 modular analyzer series
The cobas link is an integrated system consisting of a PC ( cobas link data station) and the related software.
The cobas link works as a gateway for retrieving and distributing information—such as Instructions for Use, test- and lot-specific instrument settings—from the Roche infrastructure to cobas instruments in the laboratory. The cobas link is part of the cobas e -services.
The user interface for working with cobas link is the cobas
screen is reachable on the data manager via the screen sharing function at the side bar.
Figure 2-8 Screen cobas e-library u
For more information about cobas link, see
cobas link platform and functions (p. 75).
A separate Operator’s Manual for the cobas e-library is available. u
For more information on working with the e-library, please refer to the cobas e-library
Operator’s Manual.
Roche Diagnostics
60 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 2 Overview system components
Hardware components
Hardware components
Example configuration with a c 702 module
The hardware components of the cobas 8000 instrument are: o
Core unit - input / output of samples o
ISE module for the determination of ions o
Module sample buffer - one for each instrument module o c 701 / c 702 / c 502 photometric modules for clinical chemistry analyses o e 602 module for immunoassay analyses
A
A Core unit
B ISE module
Figure 2-9
B C D C E C
C Module sample buffer
D c 702 module
E
F c e
502 module
602 module
Example of a cobas 8000 configuration. The control unit is not presented in this figure.
Example configuration with a c 701 module
F
A
A Core unit
B ISE module
Figure 2-10
B C D C E C
C Module sample buffer
D c 701 module
E
F c e
502 module
602 module
Example of a cobas 8000 configuration. The control unit is not presented in this figure.
F
Roche Diagnostics
Operator’s Manual · 4.2.1
61
2 Overview system components
Hardware components cobas® 8000 modular analyzer series
Product names The cobas 8000 instrument consists of the following products and their corresponding units: o
Core unit
O
Rack sampler unit
O
Rack conveyor o
ISE module o cobas c 701 module
O c 701 analyzer unit
O c 701 module sample buffer o cobas c 702 module
O c 702 analyzer unit
O c 702 module sample buffer, including reagent manager (automatic loading/unloading system for reagent packs) o cobas c 502 module
O c 502 analyzer unit
O c 502 module sample buffer o cobas e 602 module
O e 602 analyzer unit
O e 602 module sample buffer
Main features of the cobas 8000 instrument
This section presents some basic features:
Core unit o
Up to 1000 samples/h (up to 200 racks/h) o
With tube rotation: Up to 800 samples/h (< 180° turn), up to 600 samples/h (> 180° turn) o
Loading and unloading area: Max. 300 samples per area (60 racks per area)
Module sample buffer o
20 sample racks o
5 auto QC racks in a temperature controlled compartment (12 to 16 °C)
ISE module o
Available in 2 configurations:
O
With one ISE unit: Up to 900 tests/h (300 samples/h)
O
With two ISE units: Up to 1800 tests/h (600 samples/h) o
3 electrolyte applications c 701 / c 702 module o
Up to 2000 tests/h o
70 positions for cobas c packs large o
Automatic loading / unloading of reagent packs ( c 702 only) o
Applications:
O
Approx. 200 photometric applications
O
8 calculated tests
O
3 serum indices
Roche Diagnostics
62 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 2 Overview system components
Hardware components c 502 module o
Up to 600 tests/h o
60 positions for cobas c packs o
Automatic loading / unloading of reagent packs o
Applications:
O
Approx. 200 photometric applications
O
8 calculated tests
O
3 serum indices e 602 module o
Up to 170 tests/h o
25 positions for cobas e packs o
Applications:
O
Approx. 100 applications preprogrammable
O
Electrochemiluminescence (ECL) technology for heterogeneous immunoassays
O
8 calculated tests u
For detailed specifications, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
63
2 Overview system components
Hardware components
Core unit
cobas® 8000 modular analyzer series
Main tasks of the core unit are: o
Manage loading and unloading of sample racks o
Provide an input port for STAT samples o
Barcode reading of sample racks and sample tubes o
Powering the cobas 8000 instrument ON and OFF.
o
Optional: Automatic tube rotation
A
B
C
D
A Rack loading / unloading area
B STAT port
Figure 2-11
C
D
Core unit as seen from the front
Status LEDs
Instrument power ON / OFF
From this unit, racks are transported to individual instrument modules via a transportation line and, after being processed, returned via a return line .
Additional components of the core unit are: o
System interface port o
Cup height detector o
Power switches o
Main circuit breaker o
Timer switch
Roche Diagnostics
64 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
cobas ISE module
2 Overview system components
Hardware components
The ISE module is an individual module, which uses a potentiometric measurement to determine the concentration of sodium, potassium and chloride of any sample.
Figure 2-12 ISE module
The ISE module is available with one or two individual ISE measuring units; each unit is able to process up to 900 tests per hour (300 samples per hour).
The ISE module consists of the following main components: o
Sampling system o
Measuring system o
Reagent system
Sampling system The sampling system is composed of a sample pipetter (consisting of a pipetter arm and the sample probe), a sample syringe, and a rinse station for internal and external rinsing of the sample probe. The sample pipetter is used for both ISE units.
Measuring system
The measuring system is composed of measuring cartridges for Cl
-
, K
+
, Na
+
and a
Reference cartridge.
Reagent system The reagent system is composed of separate ISE reagents for each unit. The reagents are located behind the front door of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
65
2 Overview system components
Hardware components
Module sample buffer
cobas® 8000 modular analyzer series
The module sample buffer (MSB) is able to buffer racks in order to allow an optimized rack management. It receives the racks from the transportation line and delivers them into the analytical modules or buffers them until their next actions are required.
Additionally, a temperature controlled compartment (12 to 16 °C) extends the onboard stability of auto QC material.
The module sample buffer has no user controllable elements, except an auxiliary port that can be used if the core module is out of order in order to supply racks manually.
A
B
A Control tower of reagent manager ( c 702 only)
B Module sample buffer ( c 702)
Figure 2-13 Module sample buffers
C
C Module sample buffer of other modules
(for example c 502)
Module sample buffer ( c 702) The control tower of the reagent manager is mounted on top of the c 702 module sample buffer.
Roche Diagnostics
66 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
cobas c 701 module
2 Overview system components
Hardware components
The c 701 module is a high performance photometric module for clinical chemistry analyses.
Figure 2-14 c 701 module
The c 701 module offers a wide range of photometric clinchem tests.
The main components of the c 701 module are: o
Sampling system o
Reagent system o
Reaction disk system
Sampling system The sampling system is composed of two sample pipetters (consisting of a pipetter arm and the sample probe), a sample syringe, and a rinse station for internal and external rinsing of the sample probe.
Reagent system The reagent system is composed of two refrigerated reagent compartments, and a reagent pipetting system with four rinse stations for internal and external rinsing of the reagent probes.
Reaction disk system The reaction disk system is composed of a reaction disk, immersed in a incubator bath, six ultrasonic mixing units, a photometric measuring system, and three cell rinse units for cleaning the reaction cells once test measurement is complete.
Roche Diagnostics
Operator’s Manual · 4.2.1
67
2 Overview system components
Hardware components
cobas c 702 module
cobas® 8000 modular analyzer series
The c 702 module is a high performance photometric module for clinical chemistry analyses. The c 702 module is equipped with an automatic loading system for reagent packs. The reagent manager is the only difference to the c 701 module.
Figure 2-15 c 702 module
The c 702 module offers a wide range of photometric clinchem tests.
The main components of the c 702 module are: o
Sampling system o
Reagent system o
Reagent manager o
Reaction disk system
Sampling system The sampling system is composed of two sample pipetters (consisting of a pipetter arm and the sample probe), a sample syringe, and a rinse station for internal and external rinsing of the sample probe.
Reagent system The reagent system is composed of two refrigerated reagent compartments, and a reagent pipetting system with four rinse stations for internal and external rinsing of the reagent probes.
Reagent manager The reagent manager allows continuous loading/unloading of reagent packs during operation without manual intervention from operators. The reagent manager is mainly composed of a control tower, a transfer mechanism, and an unloading tray.
Reaction disk system The reaction disk system is composed of a reaction disk, immersed in a incubator bath, six ultrasonic mixing units, a photometric measuring system, and three cell rinse units for cleaning the reaction cells once test measurement is complete.
Roche Diagnostics
68 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
cobas c 502 module
2 Overview system components
Hardware components
The c 502 module is a photometric module for clinical chemistry analyses for medium test volumes.
Figure 2-16 c 502 module
The c 502 module offers a wide range of photometric clinchem tests.
The main components of the c 502 module are: o Sampling system o
Reagent system o Reaction disk system
Sampling system The sampling system is composed of a sample pipetter, a sample syringe, and a rinse station for internal and external rinsing of the sample probe.
Reagent system The reagent system is composed of a refrigerated reagent compartment and a reagent pipetting system with two rinse stations for internal and external rinsing of the reagent probes.
Another integral part of the reagent system is the reagent pack management system, which provides a fully automated management of reagent packs from the point of loading of new reagent packs all the way to the disposal of empty reagent packs.
Reaction disk system The reaction disk system is composed of a reaction disk, immersed in a incubator bath, three ultrasonic mixing units, a photometric measuring system, and a cell rinse unit for cleaning the reaction cells once test measurement is complete.
Roche Diagnostics
Operator’s Manual · 4.2.1
69
2 Overview system components
Hardware components
cobas e 602 module
cobas® 8000 modular analyzer series
The e 602 module is a fully automated analyzer for immunoassay analysis. It is designed for both quantitative and qualitative in vitro determinations using a large variety of tests for analysis.
Roche Diagnostics
70
Figure 2-17 e 602 module
The following are the main components of the e 602 module: o
Reagent area o
Measuring area o
Consumables area o
Pre-wash area
Reagent area The reagent area comprises the left side of the module and consists of a reagent disk, a barcode reader, a cap open/close mechanism, a microbead mixer, and two rinse stations.
Measuring area The measuring area is in the middle of the module and consists of an incubator, a sample probe, two sipper probes, two sipper rinse stations, and two measuring channels.
Consumables area The consumables area is on the right side of the e 602 module and consists of the gripper, the mixing station, the AssayTip station, the magazine lifter trays, two solid waste containers, the magazine waste compartment, and the auxiliary reagents and cleaning solutions.
Pre-wash area The pre-wash area is located on the top of the e 602 module in the middle and consists of the sipper for aspirating the reaction solution for tests recommended for prewashing, the dispenser probe for dispensing of PreClean solution, the AssayCup holder, the mixing station, and the rinse station for washing and rinsing the sipper/dispenser probes.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Core components of the system
3 Core components of the system
3
This chapter provides a brief description of components that are part of every system.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
3
71
3 Core components of the system
Table of contents cobas® 8000 modular analyzer series
Correct alignment of sample tubes on a rack.......................................................95
Roche Diagnostics
72 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
3 Core components of the system
Overview
This chapter provides a detailed description of the core components of the cobas 8000 modular analyzer series.
In addition to the system flexibility provided by numerous module combinations, every system will be delivered with core components, which are a fixed part of the system architecture. These are: o data manager o control unit o core unit o module sample buffer
All core components are described in this chapter.
Additionally, racks, trays, and sample containers are described in this chapter.
Roche Diagnostics
Operator’s Manual · 4.2.1
73
3 Core components of the system
Data manager
Data manager
cobas® 8000 modular analyzer series
The data manager PC is equipped with a 24" monitor, a keyboard and a mouse.
The data manager PC can be located directly beside the cobas 8000 instrument or in a different location from the instrument, depending on the workflow of the laboratory.
data manager software The cobas 8000 data manager software acts as a command /control center between the cobas 8000 instrument and the laboratory LIS.
The data manager software is installed on a PC.
Roche Diagnostics
74
Figure 3-1 The data manager PC - example of installation and software GUI
Data distribution As part of the laboratory workflow, the data manager processes data in real time between the cobas 8000 instrument and the LIS of the laboratory.
The workflow that follows, present an overview about the type of data, their origin and their potential target:
2UGHUV
‡6DPSOH
5HVXOWV
‡6DPSOH
‡4&
2UGHUV
‡6DPSOH
5HVXOWV
‡6DPSOH
‡4&
‡&DO
2UGHUV
‡6DPSOH
‡4&
‡&DO
5HVXOWV
‡6DPSOH
‡4&
‡&DO
/,6 '0
$ODUPV
‡'DWDDODUPV
‡,QVWUXPHQWDODUPV
&8 ,QVWUXPHQW
$ODUPV
‡'DWDDODUPV
‡,QVWUXPHQWDODUPV
Figure 3-2 cobas 8000 data manager and its related data distribution
The data manager processes orders from the LIS and is able to transfer sample results from the cobas 8000 system.
The data manager manages and displays QC results and patient results. It can also be used for traceability purposes.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system cobas link platform and functions
cobas link platform and functions
The cobas link platform is the gateway for retrieving and distributing information from the Roche TeleService Net to cobas instruments in the laboratories. Instructions for Use, value sheets, important notes, and Customer Letters are examples of the information available via cobas link. Data for the instrument like test- and lotspecific instrument settings are also transmitted.
The cobas link is an integral and mandatory part of the cobas 8000 modular analyzer series. The information on the data manager is updated automatically via cobas link.
The instrument software indicates when new information is available for download on the data manager.
TeleService Net (TSN) The TeleService infrastructure provides information services. These services are communicating securely via the Internet with its counterpart the cobas link at the customer end.
The illustration below explains how cobas link communicates as part of cobas e services.
7HOH6HUYLFHLQIUDVWUXFWXUH
FREDV¬OLQN
,QWHUQHW
GDWD¬PDQDJHU
FREDVLQVWUXPHQWV
Figure 3-3 cobas e-services cobas link functions These functions are available by cobas link: o e-barcodes (e-BC):
O Test specific instrument settings
O
Values of calibrators and controls o e-package inserts (e-PI):
O
Instructions for Use
O Value sheets of calibrators and controls
O
Important notices (e.g., re-assigned control values)
O Announcements of the local technical support o e-reference documents (current product information) o Screen sharing: Function to support the instrument and the customer.
Roche Diagnostics
Operator’s Manual · 4.2.1
75
3 Core components of the system
Control unit
Control unit
cobas® 8000 modular analyzer series
NOTICE Damage to the instrument due to magnetic fields r Keep the touchscreen, computer and any disks away from magnetic fields.
The control unit hardware consists of a PC, a touchscreen monitor, a keyboard, and a mouse.
Control unit software The control unit software which is installed on the control unit PC, controls all instrument functions. Among others, it monitors all system functions and displays all types of order and result information.
The software offers a graphical user interface (GUI) for the control of all instrument functions by the operator. Performing any action on the GUI is possible either by using the touchscreen, the mouse or related key shortcuts.
The figure presented below is an example of the control unit:
Figure 3-4 Control unit PC - example of installation and software GUI u
For an introduction to the user interface, see:
Touchscreen monitor
The system is equipped with a touchscreen monitor. The monitor is used: o
To display information o
To navigate through the software o
To initiate instrument functions
Use your finger to touch on-screen items that you want to request or change. Most of the items within the software can be accessed using the touchscreen. Touch the item desired (for example, menu bar, list box, text box, button, etc.) to complete your task.
For example, to display the Data Review submenu in the Workplace menu, touch
Workplace , then the Data Review tab.
q When touching the screen, be sure to tap , not press . The tap must be of short duration. To touch the screen, you can use your finger or a pointing device.
Roche Diagnostics
76 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Control unit
Selecting Items To select a successive range of items in a list, press the Shift key and touch the first item in the range. While continuing to press Shift, touch the last item in the range. All items, including the first and last items touched in the range, are highlighted. You may also touch the first item in the list and drag your finger to the last item in the list.
To select multiple, nonconsecutive items, press the Ctrl key, then touch the desired items.
Keyboard
The keyboard is used to navigate through the software and to enter information.
Most system functions can be performed via the touchscreen. By using combinations of individual keys, also called shortcut keys, these functions can be executed too.
u
For more information, see Shortcut keys (p. 266).
Mouse
A mouse is available to navigate through the software.
The mouse can be used to select items on the screen and to place the cursor at an insertion point in a text box. To select an item using the mouse, move the mouse over the item and then click.
Printer
The system uses a laser printer. The printer can be ordered as an optional accessory.
Roche Diagnostics
Operator’s Manual · 4.2.1
77
3 Core components of the system
Core unit
Core unit
cobas® 8000 modular analyzer series
The core unit is always located on the left side of a cobas 8000 system.
The main tasks of the core unit are: o
Placing and removing all types of racks o
Powering the system ON / OFF
A
B
C
D E
F G
A Rack loading / unloading area
B STAT port
C Status LED’s
Figure 3-5 Core unit front view
D System Power ON
E Software load status (Service only)
F System Power OFF
G Timer ON / OFF
Roche Diagnostics
78
A Power outlet for control unit and data manager
B Power inlet
Figure 3-6 Core unit rear view
A
C
B
C Power circuit breaker
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Core unit
Core unit functions
Features of the core unit are: o
Barcode reading of sample racks and sample tubes o
Automatic tube position adjustment if barcode position is misaligned (optional) o
System power switches o
Power circuit breaker - rear side o
System interface ports - rear side; for service usage only
Core unit extended functions
In addition to the functionality of the core unit on its own, there are extended hardware functions that are also controlled by the core unit.
These are conveyors, which are in charge of rack transport throughout the system structure, and extended functions that are mostly hidden from the operator. These are: o
Optimized movement of all racks inside the system.
o
Controlling dynamic rack allocation of all module sample buffers that are available on a cobas 8000 instrument configuration.
o
Module sample buffer units are physically located beside each module, but based on their function, they belong to the core unit.
o
Managing the allocation of QC material inside the temperature controlled compartment in the module sample buffers.
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A Core unit
Figure 3-7
B
B Module sample buffer
Core unit and one module sample buffer
In a full size system there are up to 4 module sample buffers - fully controlled by the core unit.
79
3 Core components of the system
Core unit
Rack loading and unloading
cobas® 8000 modular analyzer series
Loading and unloading racks is performed via the top section of the core unit. The system allows continuous loading and unloading of racks even if the system is in operation when the green status LEDs are on.
q o In accordance with Good Laboratory Practice (GLP), keep the cover closed during routine laboratory procedures. This protects samples in this section from being contaminated.
o Before opening the cover, check the condition of the status LED first!
o Ensure the correct position of all barcode labels before placing any rack. This will minimize errors during barcode readings! This check should be part of any pre-routine process.
o
Before placing a tray, ensure the correct direction of the tray handle, see figure 3-9
o Always move rack trays with great care in order to prevent any splashing between samples. This will prevent any cross-contamination of sample material!
Viewed from the top, the rack sampler unit features four lanes where rack trays with sample racks can be loaded or unloaded to the instrument.
A
C
D
B E
Roche Diagnostics
80
A STAT port
B Rack unloading area
Figure 3-8
C Return line
D Transportation line
E Rack loading area
Schematic top view of the rack loading and unloading areas
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Tray placement
3 Core components of the system
Racks are loaded into the system by placing them onto trays.
Core unit
Figure 3-9 Loading trays
In order to prevent any misplacement of racks, only a one way direction placement of racks is possible. Place racks in this direction only!
Roche Diagnostics
Operator’s Manual · 4.2.1
81
3 Core components of the system
Core unit
Rack capacities cobas® 8000 modular analyzer series
The two right lanes are used to load sample racks onto the instrument. The total capacity of the loading area is 4 × 15 racks (300 samples): The trays in the input area can hold 2 × 15 racks and the rear buffer area can also hold 2 × 15 racks.
The two left lanes collect the racks whose measurements are completed until they are unloaded. The capacity of the unloading area is also 4 × 15 racks. Racks in the output area undergo final processing and can be removed from the unloading area for further laboratory processing or archiving.
B C
A
A Status LEDs
B Unloading racks
Figure 3-10
C
Rack loading and unloading areas
Loading racks
The status LED indicates if a lane can be accessed or not.
Roche Diagnostics
82
A Status LED ON: Access OK
Figure 3-11
B
Display status of the status LEDs
Status LED OFF: No access
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
STAT rack loading
3 Core components of the system
Core unit
From the STAT port, routine and STAT racks are processed with a higher priority than patient sample racks residing in the rack loading area.
Using red racks for STAT samples is mandatory!
q Direction of barcode labels
If the tube rotation function is not used, ensure that the barcode labels are aligned correctly so that they can be scanned by the barcode readers. u
Barcode readers
All racks and all samples that are loaded onto the instrument are identified by barcode readers before they enter the system. The barcode readers perform the following tasks: o
Scan barcode of each rack o
Scan barcode of each sample within a rack u
For more information, see:
Readability of sample barcodes in racks (p. 99)
Barcode reading failed If an individual barcode is not readable, this sample is indicated as such in the user interface. Unreadable sample barcodes can be entered manually in the Barcode Read
Error window.
u
For more information, see Entering unreadable sample barcodes (p. 307).
Roche Diagnostics
Operator’s Manual · 4.2.1
83
3 Core components of the system
Core unit
Automatic tube rotation (optional)
cobas® 8000 modular analyzer series
The core unit can be equipped with the optional automatic tube rotation feature. This feature allows all sample tubes to be rotated so that the barcode label can be read.
Special rack designs ( MPA racks ) must be used to enable the rotation of the sample tubes. The rack must be defined as a rack for tube rotation under Utility > System
> Rack Assignment . u
For information about racks, see:
During rotation, the barcode reader scans barcodes on the sample tubes. When the barcode reading is successfully completed, tube rotation stops.
If the barcode is not readable during rotation, a barcode read error occurs. u
For more information on automatic tube rotation, please contact your Roche service representative.
Power switches
Roche Diagnostics
84
A Main power ON / OFF
Figure 3-12 Power switches
B Power circuit breaker in position ON
There are two types of power switches: o
A main power push button to turn the whole system ON and OFF. These push buttons are located on the front of the core unit.
o
Individual power circuit breakers for every module. These circuit breakers are located at the rear side of each module sample buffer and of the ISE module.
Power circuit breakers offer two functions: o
They will self-release in case of an internal failure of the related module o
They can be used as a normal switch to power a module ON or OFF, e.g. when performing manual maintenance tasks on this module
Power switches
Main power push-button
All power circuit breakers
Related components and function
Core unit. Powering ON / OFF the whole instrument except the cooling units
Individual module. Powering ON / OFF the affected module including its cooling unit
Table 3-1 Power switches
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Core unit
A B
A Module sample buffer - c 502 module
B Module sample buffer - c 701 module
Figure 3-13
C
D
ISE module
Core unit
Positions of power circuit breakers
(the c 701 and c 502 module are used as example)
C D
In normal routine operation, only the main power push-button is used. This allows continuous operation of all cooling units and a fast way to power the complete instrument ON and OFF.
Front panel and time switch
The instrument can be programmed for automatic start-up with the time switch on the front panel of the core unit.
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Time switch
B Lid
Figure 3-14
C D
C Core Load LED
D Timer toggle switch
Front panel of the core unit
B
85
3 Core components of the system
Core unit cobas® 8000 modular analyzer series
Time switch The digital time switch allows programming of different start-up times for each weekday. The instrument must always be powered off manually or via the Power Off
Pipe function.
u
For information about programming the time switch, see:
Set the digital time switch (p. 488)
Check timer programming (p. 491)
Timer toggle switch The toggle switch must be set to the ON position to enable the time switch. While programming the time switch, it must be set to OFF.
Core Load LED The Core Load LED lights up for a few minutes after power-on. This LED is used by
Roche service personnel only.
Roche Diagnostics
86 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Module sample buffer (MSB)
Module sample buffer (MSB)
The module sample buffer is a core component, as this unit is always part of a cobas 8000 system.
The main functions of the module sample buffer are: o
Buffering racks as part of the rack management o
Temperature controlled compartment (12 to 16 °C) for extended shelf life of the auto QC material o
A backup port to insert single racks if a backup operation is necessary.
u
For details on how to use this port, see Backup Operation (p. 497).
Roche Diagnostics
Operator’s Manual · 4.2.1
A Module sample buffer
Figure 3-15 Module sample buffer
A B
B Backup operation port for manual rack supply
Each module sample buffer can provide racks to any module at any time. Via the transportation line and the return line, every rack can be moved from the MSB into a module for processing (e.g., for reruns), or moved to the rack unloading area.
The ISE module and the first photometric module share one module sample buffer.
87
3 Core components of the system
Module sample buffer (MSB) cobas® 8000 modular analyzer series
A Water tank
B Water inlet
Figure 3-16
A B C D
C Power circuit breaker
D Power inlet
Module sample buffer rear view
Physically, the module sample buffer is directly aligned with a module. Logically, it is fully controlled by the core unit.
The module sample buffer does not provide any waste drain; this is provided by the corresponding module.
Roche Diagnostics
88 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Sample containers, racks and trays
Sample containers, racks and trays
This chapter describes the different sample containers and components used to transport samples.
Overview sample and rack terms
This chapter gives information about racks and samples. Terms such as sample class , sample type , and rack class are used.
Sample classes and rack classes The instrument is able to process different sample classes. The sample classes are allocated to rack classes. Each rack class has an individual rack color. The sample and rack classes are: o
Patient samples
O
Routine
O
STAT
O
Rerun o
Calibrators o
Controls
Sample types and rack ID Patient samples are available with different sample types. The sample types are: o
Serum/Plasma o
Urine o
CSF o
Supernatant o
Whole blood ( c 502 only) o
Other
For each sample type, rack IDs are allocated in rack number ranges. To process these different sample types, the rack number range must be defined for each sample type. u
For more information about rack number ranges, see:
Rack classes and colors of standard racks (p. 93)
Roche Diagnostics
Operator’s Manual · 4.2.1
89
3 Core components of the system
Sample containers, racks and trays
Sample containers
cobas® 8000 modular analyzer series
The material to be analyzed is supplied to the instrument in sample containers.
Sample containers are available in different shapes: tubes or cups .
A
A Sample tube
B Micro cup
Figure 3-17
B C D
C Standard cup
D False bottom tube
A subset of sample container variations
Standard sample tubes Standard sample tubes are used for larger material volumes.
Standard sample tubes have the following dimensions: o
Diameter 13 mm, length 75 or 100 mm o
Diameter 16 mm, length 75 or 100 mm
Standard and micro cups Standard cups and micro cups are used for small amounts of sample material. Both can be placed directly into a rack or into 16 mm sample tubes. In the latter case, the sample tube can be labelled with a barcode label.
u
For details, see
Standard cups and micro cups (p. 214).
Non-standard and false bottom tubes
Non-standard tubes and false bottom tubes can be used for patient samples and controls. Both can be inserted directly onto a rack.
u
For details about containers, see:
Container specifications (p. 213)
Which container for which application?
Roche Diagnostics
90 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Racks
3 Core components of the system
Sample containers, racks and trays
For the cobas 8000 system, different rack types and classes are available. This chapter explains all rack details.
Rack types
For the cobas 8000 system, two rack types are available: Standard racks and MPA racks.
o
Standard racks are used as transport carriers for all types of sample containers throughout the cobas 8000 system. You can mix 13 and 16 mm sample tubes on one standard rack.
o
MPA racks allow the use of the automatic tube rotation function (if installed).
MPA racks are used as transport carriers either for 13 mm or 16 mm sample tubes. For the tube rotation function, additional settings on the system are necessary.
A B D
Roche Diagnostics
Operator’s Manual · 4.2.1
C
A Standard rack
B Spring clips, allow the use of different tube diameters
C Rubber bottom, ensures the proper orientation for reading of sample barcode
Figure 3-18 Comparison of racks
D MPA rack, for automatic tube rotation
(without spring clips and rubber bottom)
Characteristics
Tube diameter
Cup on rack
(standard or micro cup)
Sample classes All
Color of routine rack
Standard rack
Flexible,

13 mm – 16 mm
Cup adapters available for tubes with  13 mm or less
Can be used
MPA rack
Fixed,

13 mm or 16 mm
Not supported
Gray
For routine, STAT, and rerun samples only
Different colors and rack ranges available for different sample types
Table 3-2 Rack types and characteristics u
For more information, see:
Rack classes and colors of standard racks (p. 93)
Rack classes and colors of MPA racks (p. 93)
91
3 Core components of the system
Sample containers, racks and trays cobas® 8000 modular analyzer series
Rack types Rack classes Sample container Tube rotation function
Standard rack
MPA rack for 13 or 16 mm tubes
All rack classes
Routine/Rerun
All sample containers
Standard tubes
Cups and cups on tube – l
– l
STAT
(2)
Calibrator
Non-standard tubes
False bottom tubes
–
– l (1) l
–
Control
Wash
–
–
–
–
Table 3-3 Tube rotation depending on rack types, rack classes, and sample containers
(1) False bottom tubes can be rotated if special tubes with a round bottom are used.
(2) The MPA STAT racks have rack range overlapping with the standard red STAT racks. Therefore, either MPA STAT racks or standard STAT racks can be used in the same rack range.
Rack number ranges
Different sample types, such as Ser/Pl or urine, can be processed on the analyzer. To process these different sample types on the different rack types (routine, rerun,
STAT), rack number range s must be defined for each sample type and rack type.
As an example, some number ranges are presented below: o
Serum: Rack number range 001–100 o
Urine: Rack number range 401–500 u
To assign a rack number range to a sample type, see
Rack ID
Each rack is equipped with an identification number. This unique number is called rack ID.
Every rack is identified and registered when its barcode ID is scanned by the barcode reader of the core unit.
A
B
A Rack ID – operator readable
Figure 3-19 Rack ID positions
B Barcoded rack ID – system readable
(displayed in user interface)
Roche Diagnostics
92 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Sample containers, racks and trays
Rack classes and colors of standard racks
Racks are available in different colors which are allocated to individual sample classes. This simplifies the handling of sample classes.
The table below provides an overview of rack classes.
Rack class
Routine
Rack color
Gray
STAT
Red
Display in software
50001–50999
60000–60999
70000–70999
80000–80999
S40001–S40999
Rack ID on label
0001–0999
1000–1999
2000–2999
3000–3999
S001–S999
Rerun
Pink R001–R999 R001–R999
Note: Pink racks are only used for manual reruns in non-barcode mode!
Calibrator Black C20001–C20999 C001–C999
QC
White
Wash rack
Green
Q30001–Q30999
W999
Q001–Q999
W999
Table 3-4 Rack classes and colors of standard racks
Rack classes and colors of MPA racks
MPA racks for routine samples are available in different colors. This allows the use of racks in different colors for each sample type, such as Ser/Pl or urine, according to the rack ranges defined under Utility > System > Rack Assignment .
q Overlapping of the rack ranges
The MPA racks share part of the same rack range with the standard racks. Therefore, only one type can be used within the same rack range, either MPA or standard racks.
If you load a rack into the instrument and another rack with the same rack ID is already being processed, the samples on the second rack will not be processed.
Roche Diagnostics
Operator’s Manual · 4.2.1
93
3 Core components of the system
Sample containers, racks and trays cobas® 8000 modular analyzer series
The table below provides an overview of MPA racks:
Rack class Rack colors
Routine
13 mm
Navy blue
Light green
Yellow
Brown
Display in software
60001–90000
(1)
STAT
13 mm
Navy blue S4501–S4600
Rack ID on label
1001–4000
(1)
S501–S600
Routine
16 mm
STAT
16 mm
Light blue
Light green
Yellow
Navy blue
60001–90000
(1)
1001–4000
(1)
S4801–S4900 S801–S900
Table 3-5 MPA racks for 13 mm and 16 mm sample tubes
(1) Each color has its specific ID range.
q The racks for 13 and 16 mm tubes use different colors and rack ranges, so that you can also distinguish between them.
Please contact your local Roche sales representative for a detailed ordering list for MPA racks.
Roche Diagnostics
94 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 3 Core components of the system
Sample containers, racks and trays
Correct alignment of sample tubes on a rack
Take special care to place sample tubes correctly on the rack. This is especially important for 13 mm tubes which are narrower and more likely to tilt if placed incorrectly. If the tubes are not correctly seated in an upright position on the rack, the sample probe may attempt to sample outside the tube. Or the sample probe may hit the side of the tube, causing errors and incorrect results.
CAUTION
Incorrect results when sample tubes are not aligned vertically
Incorrect placement of sample tubes in racks may cause incorrect sample pipetting, which may lead to false low results, especially when testing immunoassays.
r Ensure that sample tubes are always placed vertically in the racks.
r For sample tubes with an outer diameter of 13 mm or less, use the Roche cup adapter or use 13 mm MPA racks alternatively.
r Only use sample tubes specified for the use with the cobas 8000 instrument.
u
See
Container specifications (p. 213).
Sample tube alignment The following figure illustrates correct and incorrect alignment of a sample tube on the rack.
The tube position must be straight vertically for correct sampling. The vertical position also reduces possible barcode reading problems.
A B
A Incorrect - position misaligned
Figure 3-20 Sample tube alignment
B Correct - position perfect aligned
Cup adapters for tubes ≤ 13 mm To improve the alignment of tubes with an outer diameter ≤ 13 mm, Roche strongly recommends that Roche cup adapters are used.
Cup adapters are inserted into standard racks as shown in the following figure.
Roche Diagnostics
Operator’s Manual · 4.2.1
95
3 Core components of the system
Sample containers, racks and trays
A B C cobas® 8000 modular analyzer series
A Roche cup adapter
B Insert adapter into rack
Figure 3-21
C
Placing a cup adapter into a rack
13 mm tube placed in a rack position with cup adapter
If immunoassays are requested, cup adapters must be used for sample tubes with an outer diameter < 13 mm.
Do not use cup adapters for tubes with an outer diameter > 13 mm, because the barcode label might be damaged.
For MPA racks, the cup adapters cannot be used.
Conditions for 13 mm tubes without cup adapters
You can omit cup adapters for 13 mm sample tubes if the following preconditions are fulfilled: o
The cobas 8000 system is connected with a cobas® 8100 automated workflow series. In this clinical laboratory automation system, a gripper arm places the sample tubes into the racks.
o
The sample probes are precisely adjusted in horizontal and vertical direction on all modules. The adjustment must be performed by Roche Service personnel.
o
All spring clips are symmetrically bent in the used racks (see figure 3-22 ) so that
the sample tubes are held vertically.
A B
A Incorrect - spring clips are not symmetric
Figure 3-22 Spring clips in racks
B Correct - spring clips are symmetric
Roche Diagnostics
96 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Trays
3 Core components of the system
Sample containers, racks and trays
Trays are used to transport sample racks to and from the loading / unloading section of the core unit. Each tray has a capacity of 15 racks. This corresponds to 75 samples that can be loaded onto the instrument with one tray.
Figure 3-23 A tray loaded with racks
Roche Diagnostics
Operator’s Manual · 4.2.1
97
3 Core components of the system
Sample barcodes
Sample barcodes
cobas® 8000 modular analyzer series
This chapter provides information about the sample barcodes.
Sample identification
CAUTION
All samples that are loaded onto the instrument, are identified by barcodes. Each sample barcode label provides a unique sample identification.
On the cobas 8000 system, barcode labels with the following barcode types can be used: o
Code 39 o
Code 128 o
ITF o
NW7
Incorrect results due to barcode reading errors
Barcode reading errors could potentially go undetected when a check digit is not used.
r Use only barcodes with check digits. r Use only barcode labels of a good printout quality.
r When using ITF, do not use mixed-up ID digit numbers.
u
For further barcode specifications, see
Scan range for sample barcodes
Confirm that the barcode zone starts at a minimum of 20 mm above the bottom of the tube. The barcode must be within the zone of 63 mm and must have a blank area of ≥ 5 mm at both ends of the barcode zone, as shown in the figure below. Stick the label in exact alignment with the centerline of the sample tube in order to prevent scanning errors.
17 mm
63 mm
20 mm
Figure 3-24 Scan range of sample barcode reader
Roche Diagnostics
98 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
3 Core components of the system
Sample barcodes
Incorrect results due to misplaced barcode label
Barcode reading errors could potentially go undetected when a label is attached wrongly.
r Observe the designated scan range. Keep at least 5 mm distance between the label and the top of the sample tube.
r Attach the label upright to the sample tube (max. 5° inclination). Do not overlap labels.
r Do not use a wet label or a label with any writing on it.
Readability of sample barcodes in racks
To prevent barcode read errors it is necessary to place the barcode labels on the tubes correctly and to align the tubes into the rack correctly.
Standard racks If in a standard rack a barcode label on a sample tube is placed in a direction outside the barcode reading area, the barcode label cannot be read. Operators must place the sample tube with the barcode label to the direction of the barcode reader.
A B A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Barcode label in line
Figure 3-25
B Barcode label out of line
Barcode label positions in and out of line q Ensure that the center of the barcode label and the open slot are always in line . The system can only read the barcode if the label is correctly positioned. Otherwise, a barcode read error will be issued.
MPA racks If MPA racks are used and the core unit is equipped with the automatic tube rotation feature, the instrument is able to rotate the sample tubes so that the barcode can be read. The rack must be defined as a rack for tube rotation under Utility > System
> Rack Assignment .
If a rack is identified as a rack for tube rotation, rotation is performed for each sample tube on this rack. During rotation the barcode reader scans the sample tubes. When the barcode reading is successfully completed, tube rotation stops.
In case that the barcode is not readable during rotation, a barcode read error occurs.
99
3 Core components of the system
Sample barcodes cobas® 8000 modular analyzer series u
For more information, see:
Automatic tube rotation (optional) (p. 84)
Entering unreadable sample barcodes (p. 307)
Roche Diagnostics
100 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
cobas ISE module
4 cobas ISE module
4
This chapter provides a detailed description of the ISE module, ISE components,
ISE functions and technical specifications.
In this chapter
Chapter
4
Roche Diagnostics
Operator’s Manual · 4.2.1
101
4 cobas ISE module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
102 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
4 cobas ISE module
Overview
The ISE module is able to measure the concentration of ions in a liquid. It uses flowthrough ion-selective electrodes and a reference electrode. Each electrode is sensitive to an individual type of ion.
Three types of ions can be measured: o
Sodium o
Potassium o
Chloride
The ISE module is available with one or two measuring units. The throughput can be up to 1800 tests per hour if the ISE module is equipped with two measuring units (up to 300 samples per hour and unit).
Figure 4-1 ISE module
Components of the ISE module The ISE module can be subdivided into the following components: o Sampling area u
See
o Measuring area u
See
o Reagent system u
See
o Components behind the front doors u
See
o Components at the rear side of the module u
See
Roche Diagnostics
Operator’s Manual · 4.2.1
103
4 cobas ISE module
Top view
Top view
cobas® 8000 modular analyzer series
Presented below is the ISE module as seen from the top.
A
Roche Diagnostics
104
B
A ISE sampling area
Figure 4-2
B ISE measuring area
ISE components as seen from the top
The top of the ISE module includes the sampling and measuring areas. The following sections describe these areas.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Sampling area
Given below is a description of components and positions:
A
4 cobas ISE module
Top view
B
C
D
E
F
G
A Sample probe
B Sampling position
C Rinse station
D Sample Cleaner 2
Figure 4-3
E
F
G
Components of the sampling area
Sample Cleaner 1
Measuring position of ISE unit 2
Measuring position of ISE unit 1
ISE sample probe The ISE sample probe transports small sample volumes from a sample tube, located in a sample rack, to the dilution vessel.
Sampling position When the sample tube is located beneath position (
), a small volume of the patient sample is aspirated by the sample probe.
Rinse station In order to prevent any carryover, the ISE sample probe will be cleaned with deionized water, inside and outside, before a new patient sample will be aspirated.
Sample Cleaner 1 This is a basic cleaning solution. The remaining volumes are monitored by liquid level detection. Sample Cleaner 1 is not part of a regular ISE sequence and will only be used depending on if a special wash is required.
Sample Cleaner 2 This is a acid cleaning solution. The remaining volumes are monitored by liquid level detection. Sample Cleaner 2 is not part of a regular ISE sequence and will only be used depending on if a special wash is required.
u
For more information about the ISE cleaning solutions, see
Auxiliary reagents (ISE module) (p. 338).
Measuring position ISE 1 and 2 The ISE pipetter dispenses the patient sample here into a vessel which is located beneath this position.
Roche Diagnostics
Operator’s Manual · 4.2.1
105
4 cobas ISE module
Top view
Measuring area
cobas® 8000 modular analyzer series
The measuring area consists of one or two measuring units. The measuring units
ISE 1 and ISE 2 are high sensitive instruments, located in a temperature controlled environment of 35° ± 2° C. In a measuring unit the sample is mixed with reagent by ultrasound. This solution will pass through ion selective electrodes, in order to determine a concentration of individual ions.
Presented below are the main components of a measuring compartment.
A B C D
A Vessel, sippers and nozzles
B Ion selective electrodes
Figure 4-4
C
D
Pinch valve
ISE reference electrode
The ISE measuring unit as seen with the cover being removed
A schematic diagram of the ISE measurement compartment is presented in the following figure.
A B C D E F
Roche Diagnostics
106
G H G I
A Vacuum nozzle
B Sipper nozzle to supply the ISE electrodes
C Cl , K + , Na + electrodes
D Pinch valve
E Reference electrode
F Supply for reference solution
Figure 4-5 ISE schematic diagram
J K
G Ultrasonic mixer
H Vessel
I Supply for internal standard
J Supply for diluent
K Drain for ISE and reference electrodes
Vacuum nozzle Small pipetter to drain residual liquid from the vessel.
Sipper nozzle Small pipetter to aspirate liquid from the vessel into the ISE electrodes.
Ultrasonic mixer Provides a homogeneous mixture of sample and diluents / liquid.
Vessel A container to hold liquids for mixing.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 4 cobas ISE module
Top view
Cl
-
, K
+
, Na
+
electrodes The measurement electrodes use a special design. Membranes with an open liquid junction allow the selective measurement of the ion concentrations.
REF electrode This electrode uses the same design of the ion-electrodes. It is exclusively used as a reference for every measurement.
Pinch valve This pinch valve is used to control the flow of liquid that passes through the electrodes.
Vessel, sipper and nozzles
A closer view to the section around the vessel.
A B
C D E
A Dilution vessel
B Sipper nozzle to supply the ISE electrodes
C Nozzle for internal standard supply
Figure 4-6 The vessel and related parts
D Vacuum nozzle
E Nozzle for diluent supply
Roche Diagnostics
Operator’s Manual · 4.2.1
107
4 cobas ISE module
Top view
Electrodes cobas® 8000 modular analyzer series
The ISE measuring system is accommodated in a temperature-controlled compartment. It is comprised of three ISE cartridges and one reference cartridge.
ISE cartridges The measurement cartridges, each containing an ion-selective electrode, are seated to form a single flow path for the Internal Standard and the diluted sample.
The cartridges are color-coded as follows:
Green
Red
Yellow
Chloride
Potassium
Sodium
Cl
-
K
+
Na
+
Reference cartridge The blue cartridge is the reference electrode for all measurements. ISE reference solution is aspirated through this cartridge.
The difference of all voltages between the reference electrode and any ionselective electrode is a measure for the concentration of individual ions.
For every test, the voltages of both ISE IS and diluted sample solution are measured for each type of ions (Cl
-
, K
+
, and Na
+
).
The measurement of all electrodes is performed in parallel. The resulting voltages is converted into operator readable results.
Roche Diagnostics
108 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
ISE analysis workflow
4 cobas ISE module
The workflow below describes an ISE measurement sequence in single steps.
,6(PHDVXUHPHQWVHTXHQFH
Top view
,6 5()
&OHDQLQJWKHYHVVHO
'LVSHQVLQJ,6LQWRWKHYHVVHO
'UDLQLQJ,6VROXWLRQ
&DOLEUDWLRQ&O .
1D
'LVSHQVLQJ,6DQGWUDQVSRUWWRWKH&O .
1D HOHFWURGHV
0HDVXULQJDQGFKHFNLQJUHVXOWLQJVLJQDO
&DOLEUDWLRQ5()
'LVSHQVLQJ5()DQGWUDQVSRUWWRWKH
5()HOHFWURGH
0HDVXULQJUHVXOWLQJVLJQDO
,6 5()
6DPSOH',/ 5()
'UDLQLQJ,6VROXWLRQ
0HDVXULQJ&O .
1D
'LVSHQVLQJVDPSOH
$GGLQJGLOXHQWDQGPL[LQJ
7UDQVSRUWGLOXWHGVDPSOHWRWKH&O .
1D HOHFWURGHV
0HDVXULQJUHVXOWLQJVLJQDO
&DOFXODWLQJWKHUHVXOWLQUHODWLRQWRWKH
5()VLJQDO
'UDLQLQJVROXWLRQV
Figure 4-7
6DPSOH',/ 5()
(QGRI,6(VHTXHQFH
Workflow of a measurement sequence
'UDLQLQJ5()VROXWLRQ
0HDVXULQJ5()
'LVSHQVLQJ5()DQGWUDQVSRUWWRWKH
5()HOHFWURGH
0HDVXULQJUHVXOWLQJVLJQDO
Roche Diagnostics
Operator’s Manual · 4.2.1
109
4 cobas ISE module
Front view
Front view
The ISE module as seen behind the door:
A
B cobas® 8000 modular analyzer series
C
A Drain ports
B Syringes for reagents and samples
Figure 4-8
C
Components behind the front door
ISE reagents
The reagent fill level of all solutions is checked by individual counters and must be reset after placing new bottles.
Drain ports These ports will drain serum and KCL waste of the ISE module. As part of the maintenance, regular cleaning is necessary.
Syringes The sample syringe is filled with degassed and deionized water. The reagent syringes deliver Internal Standard (ISE IS) and ISE diluent (ISE DIL) to the dilution vessel.
The sipper syringe draws solutions past the ion selective electrodes and drains after a measure cycle is final.
u
For more information, see Syringes (p. 111).
ISE reagents The ISE reagents are located at the bottom of the module. u
For more information, see ISE reagents (p. 112).
Roche Diagnostics
110 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Syringes
4 cobas ISE module
Front view
The syringes use positive displacement to aspirate and dispense solutions via the corresponding probe or nozzles.
A
B
C
D
E
F
G
A Syringe IS-2
B Syringe DIL-2
C Syringe SIP-2
D Syringe IS-1
E Syringe DIL-1
F Syringe SIP-1
G Sample syringe
Figure 4-9 Location of syringes
Sample syringe The sample syringe aspirates the determined volume of sample and discharges it into the vessel. A pressure sensor is between the probe and the pipetter in order to monitor sample-aspirating state and to detect clots.
Reagent syringes The reagent syringes aspirate and dispense the following ISE reagents: o
ISE IS o
ISE REF o
ISE DIL
The IS syringe aspirates internal standard reagent from the container in the reagent compartment and dispenses it during the rinse cycle into the dilution vessel to rinse the previous sample mixture to the ISE waste container via the vacuum probe. In a second cycle it dispenses the required amount of internal standard reagent for the measurement process.
The sipper syringe (SIP) aspirates reference solution from the container in the reagent compartment and draws it through the reference cartridge containing the reference electrode, which is used to determine zero baseline values in ISE calculations. As part of this measurement process it aspirates the diluted sample from the dilution vessel and draws it through the ISE cartridge containing the electrodes for measuring chloride, sodium and potassium ions.
The DIL syringe aspirates ISE diluent from the container in the reagent compartment to the dilution vessel where it is mixed with the sample.
Roche Diagnostics
Operator’s Manual · 4.2.1
111
4 cobas ISE module
Front view
ISE reagents
cobas® 8000 modular analyzer series
A
B
C
D
E
F
A REF-2 - Reference solution
B IS-2 - Internal standard solution
C DIL-2 - Diluent
Figure 4-10 Location of ISE reagents
D REF-2 - Reference solution
E DIL-1 - Diluent
F IS-1 - Internal standard solution
ISE reference solution ISE reference solution is a liquid that passes through the reference electrode. The bottle of the ISE reference solution is placed behind the diluent bottle.
ISE diluent ISE diluent will be mixed with sample material in the vessel and then afterwards, it will be drawn through the three ion selective electrodes.
IS - Internal standard
IS solution contains predefined concentrations of Cl
-
, K
+
and Na
+
Ions. It is used as a reference solution that passes through all three ion selective electrodes. IS and sample measurement are performed alternately. Combined calculation of both measurements determine the ion concentration values of an individual sample.
Since the IS properties are stable, it is used to compensate any change in temperature.
u
For information on changing ISE reagents, see
To replace an ISE reagent container
Vacuum system
The vacuum system consists of a vacuum pump, vacuum reservoir and sample waste container. The vacuum system aspirates sample waste from the dilution vessel to the waste container. The vacuum system also draws air bubbles from the degassing unit.
Roche Diagnostics
112 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Rear view
The module as seen from the rear side.
4 cobas ISE module
Rear view
A B C D
A Waste container
B Liquid level sensor assembly
Figure 4-11
C
D
Power inlet
Power circuit breaker
ISE components as seen from the rear side
Waste container Waste container for concentrated waste solution. This waste must be treated as infectious waste according to the local regulations.
Liquid level sensor assembly Sensor to detect the maximum waste level.
Power inlet The mains supply of the module is connected here.
Power circuit breaker The power circuit breaker provides protection in case of an internal electrical short. It is also used to switch the module on or off, for example when performing manual maintenance.
Roche Diagnostics
Operator’s Manual · 4.2.1
113
4 cobas ISE module
Rear view cobas® 8000 modular analyzer series
Roche Diagnostics
114 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
cobas c 701 module
5 cobas c 701 module
5
This chapter provides a detailed description of the c 701 module and its hardware components.
In this chapter
Chapter
5
Roche Diagnostics
Operator’s Manual · 4.2.1
115
5 cobas c 701 module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
116 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
5 cobas c 701 module
Overview
The c 701 module is a fully automated, computerized instrument for in-vitro tests on a wide range of analytes. The c 701 module performs photometric assay determinations. The throughput is up to 2000 tests per hour. The related module sample buffer offers a random access buffer function for samples.
A
A Module sample buffer
Figure 5-1 c 701 module
B
B Module c 701
Components of the cobas c 701 module
The c 701 module can be subdivided into the following areas: o Sampling area u
See
o Reagent area u
See
o Reaction disk area u
See
o Components behind the front doors u
See
o Components at the rear side of the module u
See
Roche Diagnostics
Operator’s Manual · 4.2.1
117
5 cobas c 701 module
Top view
Top view
cobas® 8000 modular analyzer series
The figure below shows the top view of the module.
A
B
C
A Sampling area
B Reagent area
Figure 5-2 c 701 top view
C Reaction disk area
The top of the module includes the sampling, reagent, and reaction disk areas. The following sections describe these areas.
Roche Diagnostics
118 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Sampling area
5 cobas c 701 module
Top view
The sampling area is in charge of transporting sample fluid between a sample tube and an individual reaction cuvette.
The sampling area of the c 701 module consists of the following components: o
Two sample pipetters o
Two rinse stations for internal and external rinsing of the sample probes
A B
C D E F
A Sample pipetter B
B Sample pipetter A
C Rinse station B
Figure 5-3
D
E
F
Sample Cleaner 1
Sample Cleaner 2
Rinse station A
Sample components as seen from the rear side (safety cover removed)
Sample pipetter A sample pipetter aspirates sample liquid from sample tubes and pipettes it into reaction cells.
Rinse station The rinse station cleans the inside and outside of the probes after an individual sample has been processed. This prevents any carryover between individual samples.
Sample Cleaner 1 Is used as basic cleaning solution.
Sample Cleaner 2 Is used as acid cleaning solution.
Roche Diagnostics
Operator’s Manual · 4.2.1
119
5 cobas c 701 module
Top view
Sample pipetters cobas® 8000 modular analyzer series
A sample pipetter consists of the pipetter arm and the sample probe. When a rack is in the sampling position, the pipetter transports sample from the sample tube to a reaction cell. When aspirating, liquid level detection is accomplished by highly sensitive capacitance measurement, and clot detection by means of pressure measurements.
After sample has been aspirated, the probe is raised from the sample and is moved to the reaction disk. The sample probe arm lowers the probe into the reaction cell at the sample dispense position. Sample is dispensed while the beveled sample probe tip is in contact with the bottom of the reaction cell. This ensures that a precise volume of sample is deposited into the bottom of the cell even when using a low dispense volume. The sample probe is spring-mounted on the arm to avoid damage to the probe or reaction cell.
Sample probe rinse station
The sample probe rinse station is located between the sample aspiration position and the reaction disk. To prevent carryover, the sample probe is rinsed with deionized water both externally and internally before aspirating a new sample.
The rinse station is also the home position for the sample probe when the pipetter is in Standby.
Roche Diagnostics
120 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reagent area
5 cobas c 701 module
Top view
The reagent area is in charge of transporting reagents to individual reaction cuvettes.
The reagent area of this module consists of the following components: o
Two refrigerated reagent compartments for storing up to 70 reagent packs
( cobas c packs large) o
Four reagent pipetters for aspirating and dispensing reagents o
Four rinse stations for internal and external rinsing of the reagent probes
D E F
A
B
C
G
H
A Reagent disk A
B R1 reagent pipetter of disk A
C Rinse stations
D R2/R3 reagent pipetter of disk A
Figure 5-4
E
F
G
H
R2/3 reagent pipetter of disk B
RFID reader (below cover)
Reagent disk B
R1 reagent pipetter of disk B
Reagent components of the c 701 modules
Reagent disk A, B Two round compartments to accommodate all reagent packs. Both compartments are refrigerated and temperature-controlled.
Individual covers protect the compartments. Each cover has an integrated RFID
(Radio Frequency IDentification) reader.
Reagent pipetters of disk A, B Four rotating articulated-arm pipetters are used to transport the reagents from the reagent compartments into the reaction cells. The reagent probe is equipped with a liquid level detector. When a new reagent pack is loaded, the reagent level inside every container of the reagent pack is checked.
Roche Diagnostics
Operator’s Manual · 4.2.1
121
5 cobas c 701 module
Top view cobas® 8000 modular analyzer series
Reagent storage compartments
Reagent packs are stored in two refrigerated compartments for disk A and B. One reagent disk can take up to 35 reagent packs, so the total capacity is 70 reagent packs.
Reagent packs must be loaded manually into the compartments. The large cobas c packs are identified by an RFID label. This label is scanned by an RFID reader in the compartment covers.
Prior to loading, new large cobas c packs must be opened by unscrewing the caps.
You may use the cobas c pack opener, a semiautomatic device that facilitates and accelerates opening of cobas c packs. Then lift off the reagent disk cover and place the
reagent packs manually, see figure 5-5.
u
For detailed information how to load reagents, see Loading reagent packs (p. 367).
A
C
D
B E
A RFID label
B RFID label on a cobas c pack large
Figure 5-5
C
Reagent loading at disk B
RFID reader unit disk A D RFID reader unit disk B
E Reagent loading (protection cover removed)
When a new reagent pack is placed on a reagent disk and the cover is closed, an RFID reader scans the following data from the reagent pack's RFID label: o
Reagent pack ID (for example, 0737550) o
Lot ID o
Reagent pack number (sequence number, for example, 01983)
Roche Diagnostics
122 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 5 cobas c 701 module
Top view
Reagent pipetters
The reagent pipetting system is composed of four reagent pipetters (R1-A and
R2/3-A for reagent disk A and R1-B and R2/3-B for reagent disk B) and four reagent syringes.
The reagent pipetters transport the reagents from the reagent compartments to the reaction disk.
Before each pipetting, the reagent probes are externally and internally rinsed with deionized water. After reagent has been aspirated, the probe moves from the reagent compartment to the reaction disk. There, the reagent volume is dispensed into a reaction cell containing the sample. Unlike the sample probe, the reagent probe is not lowered into the reaction cell. Reagent is dispensed from the top of the reaction cell.
The mechanical cycle of the module allows for three different reagent timings: R1, R2, and R3. The R1 pipetter pipettes reagents at R1 timing. The R2 pipetter pipettes reagents at R2 and R3 timings.
Reagent probe rinse stations The reagent probe rinse stations are located between the reagent compartments.
After each reagent dispense, deionized water is flushed through the probes and onto their outside surfaces.
The rinse stations are the home position for the reagent probes when the module is in
Standby.
Roche Diagnostics
Operator’s Manual · 4.2.1
123
5 cobas c 701 module
Top view
Reaction disk area
cobas® 8000 modular analyzer series
The reaction disk area of the module consists of the following components: o
A reaction disk with the reaction cells, which are immersed in the incubator bath.
o
Six ultrasonic mixing units for non-contact mixing of reaction mixtures.
o
A photometric measuring system which continually measures the absorbance of the reaction mixture in each of the reaction cells.
o
Three cell rinse units for cleaning the reaction cells once a test measurement is complete.
o
An Ecotergent reagent pack in the right reagent disk (B). Ecotergent is an additive for the incubator bath.
The following figure presents the major parts of the reaction disk.
D E F
A B
C
A Incubator bath
B Reaction cell – an individual segment
C Ultrasonic mixers
Figure 5-6
D
E
Cell rinse unit 3
Cell rinse unit 2
Reaction disk – c 701
F Cell rinse unit 1
G Photometer lamp
G
Roche Diagnostics
124 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reaction disk
5 cobas c 701 module
Top view
The reaction disk of the c 701 module carries 406 reusable plastic reaction cells (also called cuvettes ). These reaction cells are grouped together in 14 segments with 29 cells each. All reaction cells are seated in a temperature-controlled bath. This incubator bath maintains the cells at the required temperature of 37 °C (98.6 °F).
q The reaction cells should be replaced once a month since they gradually deteriorate over long use. Carry out cell blank measurement once a week after rinsing the reaction system to check the integrity of all cells.
u
See To perform a cell blank measurement (p. 703).
Ultrasonic mixers
The ultrasonic mixing units mix the reagents within each of the reaction cells to ensure a homogeneous distribution between sample and reagent fluid.
Corresponding to the three reagent timings R1, R2, and R3, there are independent mixing units.
To avoid any spillage, the filling level of the incubator bath is checked before the mixing process starts. If the liquid level is too low, an alarm (MIXSTP) is issued and mixing is not performed.
Contamination on the surface of the ultrasonic mixing units will cause inadequate mixing. The surface should be cleaned at least once every three months.
The ultrasonic output intensity is continually monitored. If the intensity level falls below a certain limit, an alarm (MIXLOW) is issued and replacement of the ultrasonic mixing pack is required. Contact your technical support for replacement.
u
For more information, see Cleaning the ultrasonic mixers (p. 729).
Incubator bath
The figure shows the reaction cuvette segment shortly before passing the photometer windows.
The circular incubator bath is filled with temperature controlled water. The analyzer controls the temperature of the incubator bath water and keeps the reaction solution at a temperature of 37 °C (± 0.1 °C) (98.6 °F (±0.18 °F)).
Two glass windows (inner and outer) are positioned in opposite walls of the incubator bath. These windows permit light from the photometer lamp to pass through the incubator bath water and through the reaction cells in the bath. The light beam emerges from the outer window of the incubator bath and enters the instrument photometer.
A liquid level sensor detects the water level of the bath. Deionized water is automatically added to the incubator bath, as determined by the liquid level sensor, to compensate for evaporation. This occurs even in Standby.
Ecotergent Ecotergent is a non-ionic detergent for the incubator bath. It acts as a surfactant to minimize the formation of bubbles that could interfere with the photometer readings.
Ecotergent is automatically added to the incubator bath whenever the water is exchanged. Ecotergent is the substitute product to the previously used Hitergent.
u
For information on the consumption of Ecotergent, see:
Consumption of Ecotergent (p. 714)
Roche Diagnostics
Operator’s Manual · 4.2.1
125
5 cobas c 701 module
Top view
Photometer cobas® 8000 modular analyzer series
The small figure shows the photometer lamp (cover opened).
The photometer measures the absorbances of the reaction mixtures in the reaction cells. Measurements are taken of each reaction cell, as the reaction ring is turning.
The figure below illustrates the functional principle of the light beam from the photometer to the detector.
A B C D E F G H I J K L M
Roche Diagnostics
126
N
A Photometer lamp
B Water jacket
C Infrared cut filter
D Mask
E Condenser lens
Figure 5-7
I
F
G
H
J
Slit (IN)
Incubator bath
Reaction cell and dispersion
Slit (OUT)
Imaging lens
K Slit
L Photometer unit
M
N
Diffraction grating
Detector
Illustration of light path through photometer components
Photometer lamp The photometer lamp is accommodated in a water-cooled case. This design ensures a constant energy output from the lamp and it also extends the lamp life.
u
For more information about replacing the photometer lamp, see
Replacing the photometer lamp (p. 733).
Light path The light from the photometer lamp passes through the following main components: o
First incubator bath window o Incubator bath water o
Reaction cell and its contents o Incubator bath water o
Second incubator bath window o and, finally, into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This separates the light into its individual wavelengths and reflects them onto a fixed array of 12 photodiodes. Each photodiode is mounted in a fixed position to detect light at an individual wavelength.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 5 cobas c 701 module
Top view
The control unit uses the available assay parameter information to select the wavelengths and the times at which a reaction mixture's absorbance is read and results are calculated.
The control unit keeps track of which test is being performed in each reaction cell. It also knows when each reaction cell passes through the photometer light path. After measurements are completed, the control unit calculates the test results from the measured absorbance values.
Cell rinse units
3
2
1
The cell rinse units are located to the right and at the back of the reaction disk. They clean, rinse, and dry the reaction cells after the absorbance was measured.
To ensure reaction cell optical performance, the absorbance values of water-filled reaction cells are measured during the cleaning process (cell blank) and compared with the stored value from the weekly cell blank measurement. The cell blank guarantees the condition of all reaction cells within small tolerances. If any individual cell does not meet these predefined limits, it is disabled for routine use.
Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and drying of the reaction cells takes place.
5RWDWLRQDOGLUHFWLRQRIWKHUHDFWLRQULQJ
A B C D
5LQVHXQLW
G H I J K L
&HOOEODQN
PHDVXUHPHQW
M N
5LQVHXQLW 5LQVHXQLW
A D F I L C E H K N B G J M
A Liquid aspiration at the end of a reaction
B Rinse water discharge
C Rinse water aspiration
D Cell cleaner 1 discharge
E Cell cleaner 1 aspiration
F Cell cleaner 2 discharge
G Cell cleaner 2 aspiration
Figure 5-8 Cell rinse and clean functions
H Rinse water discharge
I Rinse water aspiration
J Rinse water discharge
K Rinse water aspiration and drying
L Water blank discharge
M Water blank aspiration
N Water blank aspiration and drying
Roche Diagnostics
Operator’s Manual · 4.2.1
127
5 cobas c 701 module
Top view cobas® 8000 modular analyzer series
Nozzle functions The nozzle shape is designed according to the intended function. Presented below is an overview of nozzles and their functions:
A B C
A Aspiration of liquids
Figure 5-9
B Discharging and aspiration of liquids
C Reaction cell drying
Nozzle functions
The Teflon® tip of shape C is optimized for perfect drying of the reaction cell.
Roche Diagnostics
128 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 5 cobas c 701 module
Top view
Workflow of photometric analysis
The workflow presented below illustrates a single measurement sequence:
6WDUW
&OHDQLQJWKHUHDFWLRQFHOO
&HOOEODQNPHDVXUHPHQW
'LVSHQVLQJRIVDPSOH
$GGLQJUHDJHQWV
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
&DOFXODWLQJWKHUHVXOW
&OHDQLQJWKHUHDFWLRQFHOO
$XWRPDWLF6723
(QG
Figure 5-10 Workflow of a measurement sequence
The following table gives a detailed description of the measurement workflow.
Description of a measurement sequence
1
2
Cleaning the reaction cell
Cell blank measurement
After start, mechanical parts are reset to their home positions. Then the instrument starts rinsing the reaction cell. The reaction disk rotates continuously. The rinsing nozzle (
aspirates reaction mixture from the reaction cell. A few cycles later, the reaction cell is washed with deionized water using rinsing nozzles (
/
In the next step, the reaction cell is washed with rinsing nozzles (
mechanism using CellCln 1. Thereafter, the reaction cell is washed with rinsing nozzles
(
F / G ) in the rinsing mechanism using CellCln 2. Using the rinsing nozzles ( H
/
reaction cell is rinsed with deionized water. The cell is rinsed a second time with deionized water with nozzles (
The rinse nozzle (
L ) dispenses a water blank discharge. A cell blank value is measured
3 times. If the cell blank value differs by 0.1 absorbance values (Abs) or more from the stored value from the weekly cell blank measurement, this cell will not be used for analysis.
3
Dispensing of sample
Table 5-1
After rinsing and cell blank measurement are done, the reaction cell returns to the sampling position and dispensing of sample starts.
Every 1.8 seconds, a test sequence is initiated alternating between sample probe A and B.
Workflow of a measurement sequence
Roche Diagnostics
Operator’s Manual · 4.2.1
129
5 cobas c 701 module
Top view cobas® 8000 modular analyzer series
Description of a measurement sequence
4
Adding reagents Reagents R1, R2, and R3 are added at the determined positions and time points (0, 2 and
5 minutes). Every time one of the reagents R1, R2, and R3 is added, the fluid in the cell is mixed at the corresponding mixing position by means of the ultrasonic mixer.
16.2 s - photometric cycle time 1.8 s - sampling time 3.6 s - sampling time per sample probe
(A or B)
5
Calculating result Sampling is carried out every 1.8 seconds. Measurement is performed 38 times/cell in
10 minutes. After all measurements are completed, the concentration is calculated using the absorbance at the specified points of the reaction process.
6
Cleaning the reaction cell The instrument aspirates the reaction solution using the cell rinse units and performs the wash sequence with detergent followed by rinsing with water.
7
Automatic stop
Table 5-1
The instrument goes into Standby if the Rack Reception Mode is not activated.
Workflow of a measurement sequence
Roche Diagnostics
130 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Front view
5 cobas c 701 module
Front view
This section presents all elements which are located behind the front doors.
A B
C D E F
A Components used for maintenance
B Filter of solenoid valve
C Syringes
Figure 5-11
D Cooling unit
E Detergent bottles (CellCln 1 and CellCln 2)
F Drain ports for condensation water in the vacuum system
Components behind the front doors
Components used for maintenance These controls and status LED are used for maintenance only.
Filter of solenoid valve The filter of the solenoid valve unit prevents dirt and dust being mixed into the unit when the valve opens up for air.
Syringes These syringes are in charge of transporting reagent and sample liquid.
Cooling unit The cooling unit is used to maintain a constant temperature of the incubator bath and to cool the reagent packs.
Detergent bottles These bottles are filled with detergents for the cell rinse process.
Drain ports These two ports are used to drain the two tank compartments of the vacuum system.
Roche Diagnostics
Operator’s Manual · 4.2.1
131
5 cobas c 701 module
Front view
Maintenance controls
cobas® 8000 modular analyzer series
A B C
A Control LEDs
B Maintenance tap
Figure 5-12
C Push buttons F1 and F2
Components used during maintenance
Control LEDs These LEDs show the status of the individual internal power supplies. The green color indicates, that all power supplies are working properly.
Maintenance tap This tap is used to drain the incubator bath during maintenance.
Push buttons F1 and F2 The button F1 is used for maintenance purposes. The function of the button F1 changes, depending on the selected maintenance item. It can be used, for example: o
To start the re-filling of the incubator bath.
o
To start moving the rinse nozzles up and down into a reaction cuvette in order to check the correct position of the nozzle tip.
o
To move the reagent probes horizontally.
The button F2 is used for service purposes only.
Roche Diagnostics
132 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Syringes
5 cobas c 701 module
Front view
The syringes are used to control the pipetting actions of the different probes. The probes are connected to the syringe by tubing.
The syringes are filled with degassed and deionized water, using positive displacement to aspirate and dispense solutions via the corresponding probes.
A B
A R1 syringe - disk A
B R2/R3 syringe - disk A
C R1 syringe - disk B
Figure 5-13 Location of syringes
C D E
D R2/R3 syringe - disk B
E Sample syringe - pipetter A
F Sample syringe - pipetter B
F
Reagent syringes The R1 syringe aspirates the determined volume of reagent R1 and discharges it into a reaction cell.
The R2/R3 syringe aspirates the determined volume of reagent R2/R3 and discharges it into a reaction cell, also according to the test setup.
Sample syringe A sample syringe aspirates the determined volume of sample and discharges it into a reaction cell. A pressure sensor between the probe and the pipetter monitors the sample-aspirating state and detects clots.
Roche Diagnostics
Operator’s Manual · 4.2.1
133
5 cobas c 701 module
Front view
Detergents and filter
cobas® 8000 modular analyzer series
A
A Filter of cooling unit
B
B Cell cleaner 1 (CellCln 1)
C Cell cleaner 2 (CellCln 2)
C
Figure 5-14 Filter and detergent bottles
Filter of cooling unit The radiator of the cooling unit is equipped with a dust filter that must be cleaned in course of regular maintenance.
Detergent bottles The two large bottles located behind the front door of the module contain detergents for cleaning purposes. Cell cleaner 1 is a basic detergent and Cell cleaner 2 is an acid detergent.
Vacuum system
The vacuum system is located behind the front of the module. It consists of vacuum pumps, vacuum tanks, vacuum sensors, and connecting tubing.
The vacuum system aspirates reaction mixture waste from the reaction cells to the reaction waste container and removes reaction cell rinse water from the module through the main drain line.
The vacuum system must be checked routinely as part of the maintenance.
u
To locate the drain ports of the vacuum system, see figure 5-11, p. 131.
Roche Diagnostics
134 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Rear view
The module as seen from the rear side.
5 cobas c 701 module
Rear view
E
F
G
A Outlet for diluted waste
B Outlet for highly concentrated waste
C Liquid level sensor assembly
D Water tank
Figure 5-15 c 701 rear view
A B C D
E Water inlet
F Power circuit breaker
G Power inlet
Diluted waste Main drain outlet - connected to a drain pipe.
Highly concentrated waste Outlet for highly concentrated waste. This waste must be treated as infectious waste according to the local regulations.
q o Further handling of concentrated waste solution depends on the facilities of the laboratory. Some laboratories use containers; others may connect hoses leading to their drainage system. o When using waste containers, always make sure that the container is present and empty at the beginning of daily analysis.
Liquid level sensor assembly Water tank cap with a float for the integrated level control.
Water tank This tank buffers peak water consumptions during routine work.
Water inlet Main water supply.
Roche Diagnostics
Operator’s Manual · 4.2.1
135
5 cobas c 701 module
Rear view cobas® 8000 modular analyzer series
Power inlet The mains supply of the module is connected here.
Power circuit breaker The power circuit breaker provides protection in case of an internal electrical short. It is also used to switch the module on or off, for example when performing manual maintenance.
Roche Diagnostics
136 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
cobas c 702 module
6 cobas c 702 module
6
This chapter provides a detailed description of the c 702 module and its hardware components.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
6
137
6 cobas c 702 module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
138 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
6 cobas c 702 module
Overview
The c 702 module is a fully automated, computerized instrument for in-vitro tests on a wide range of analytes. The c 702 module performs photometric assay determinations. The throughput is up to 2000 tests per hour. The related module sample buffer offers a random access buffer function for samples.
The c 702 module is equipped with the reagent manager, which is an automatic loading/unloading system for reagent packs. The reagent manager is the only difference to the c 701 module.
A
B
A Reagent manager
B Module sample buffer c 702
Figure 6-1 c 702 module
C
C Module c 702
Components of the cobas c 702 module o
The c 702 module can be subdivided into the following areas:
Sampling area u
See
o
Reagent area u
See
o
Reagent manager components u
See
o
Reaction disk area u
See
o
Components behind the front doors u
See
o
Components at the rear side of the module u
See
Roche Diagnostics
Operator’s Manual · 4.2.1
139
6 cobas c 702 module
Top view
Top view
cobas® 8000 modular analyzer series
The figure below shows the top view of the module.
B
A
C
D
A Reagent manager
B Sampling area
Figure 6-2 c 702 top view
C Reagent area
D Reaction disk area
The top of the module includes the sampling, reagent, and reaction disk areas, as well as the reagent manager components. The following sections describe these areas.
Roche Diagnostics
140 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Sampling area
6 cobas c 702 module
Top view
The sampling area is in charge of transporting sample fluid between a sample tube and an individual reaction cuvette.
The sampling area of the c 702 module consists of the following components: o
Two sample pipetters o
Two rinse stations for internal and external rinsing of the sample probes
A B
C D E F
A Sample pipetter B
B Sample pipetter A
C Rinse station B
Figure 6-3
D
E
F
Sample Cleaner 1
Sample Cleaner 2
Rinse station A
Sample components as seen from the rear side (safety cover removed)
Sample pipetter A sample pipetter aspirates sample liquid from sample tubes and pipettes it into reaction cells.
Rinse station The rinse station cleans the inside and outside of the probes after an individual sample has been processed. This prevents any carryover between individual samples.
Sample Cleaner 1 Is used as basic cleaning solution.
Sample Cleaner 2 Is used as acid cleaning solution.
Roche Diagnostics
Operator’s Manual · 4.2.1
141
6 cobas c 702 module
Top view
Sample pipetters cobas® 8000 modular analyzer series
A sample pipetter consists of the pipetter arm and the sample probe. When a rack is in the sampling position, the pipetter transports sample from the sample tube to a reaction cell. When aspirating, liquid level detection is accomplished by highly sensitive capacitance measurement, and clot detection by means of pressure measurements.
After sample has been aspirated, the probe is raised from the sample and is moved to the reaction disk. The sample probe arm lowers the probe into the reaction cell at the sample dispense position. Sample is dispensed while the beveled sample probe tip is in contact with the bottom of the reaction cell. This ensures that a precise volume of sample is deposited into the bottom of the cell even when using a low dispense volume. The sample probe is spring-mounted on the arm to avoid damage to the probe or reaction cell.
Sample probe rinse station
The sample probe rinse station is located between the sample aspiration position and the reaction disk. To prevent carryover, the sample probe is rinsed with deionized water both externally and internally before aspirating a new sample.
The rinse station is also the home position for the sample probe when the pipetter is in Standby.
Roche Diagnostics
142 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reagent area
6 cobas c 702 module
Top view
The reagent area is in charge of transporting reagents to individual reaction cuvettes.
The reagent area of this module consists of the following components: o
Two refrigerated reagent compartments for storing up to 70 reagent packs
( cobas c packs large) o
Four reagent pipetters for aspirating and dispensing reagents o
Four rinse stations for internal and external rinsing of the reagent probes
D E F
A
B
C
G
A R1 reagent pipetter of disk A
B Reagent disk A
C Rinse stations
D R2/3 reagent pipetter of disk A
Figure 6-4
E
F
G
R2/3 reagent pipetter of disk B
R1 reagent pipetter of disk B
Reagent disk B
Reagent components of the c 702 modules
Reagent disk A, B Two round compartments to accommodate all reagent packs. Both compartments are refrigerated and temperature-controlled.
Reagent pipetters of disk A, B Four rotating articulated-arm pipetters are used to transport the reagents from the reagent compartments into the reaction cells. The reagent probe is equipped with a liquid level detector. When a new reagent pack is loaded, the reagent level inside every container of the reagent pack is checked.
Roche Diagnostics
Operator’s Manual · 4.2.1
143
6 cobas c 702 module
Top view cobas® 8000 modular analyzer series
Reagent storage compartments
Reagent packs are stored in two refrigerated compartments for disk A and B. One reagent disk can take up to 35 reagent packs, so the total capacity is 70 reagent packs.
Reagent packs are loaded automatically into the compartments by the reagent manager. The cobas c packs large are identified by an RFID label. This label is scanned by an RFID reader inside the reagent manager.
u
For more information, see:
Loading reagent packs (p. 367)
Reagent pipetters
The reagent pipetting system is composed of four reagent pipetters (R1-A and
R2/3-A for reagent disk A and R1-B and R2/3-B for reagent disk B) and four reagent syringes.
The reagent pipetters transport the reagents from the reagent compartments to the reaction disk.
Before each pipetting, the reagent probes are externally and internally rinsed with deionized water. After reagent has been aspirated, the probe moves from the reagent compartment to the reaction disk. There, the reagent volume is dispensed into a reaction cell containing the sample. Unlike the sample probe, the reagent probe is not lowered into the reaction cell. Reagent is dispensed from the top of the reaction cell.
The mechanical cycle of the module allows for three different reagent timings: R1, R2, and R3. The R1 pipetter pipettes reagents at R1 timing. The R2 pipetter pipettes reagents at R2 and R3 timings.
Reagent probe rinse stations The reagent probe rinse stations are located between the reagent compartments.
After each reagent dispense, deionized water is flushed through the probes and onto their outside surfaces.
The rinse stations are the home position for the reagent probes when the module is in
Standby.
Roche Diagnostics
144 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reagent manager
6 cobas c 702 module
Top view
The reagent manager automatically loads and unloads reagent packs onto and from the reagent disks (A and B). Once you have placed a reagent pack in the loading port, the system automatically decides on which reagent disk the reagent pack is loaded
(unless specified by the operator). The reagent manager allows you to load reagent packs when the green LED at the loading port is on (during Standby or Operation).
The reagent manager of the c 702 module consists of the following components:
A B C D
A Control tower
B Control panel
Figure 6-5
C Unloading tray
D Transfer mechanism of the gripper
Components of the reagent manager
Control tower The control tower, located on top of the module sample buffer, includes a control panel, loading port, buffer rotor, return port, and cap waste box.
The buffer rotor, which has a capacity of ten reagent packs, holds them until they are loaded into the reagent disks. The reagent manager removes the caps from the reagent packs. Thereafter, the packs are transferred into the reagent disks immediately.
Transfer mechanism The transfer mechanism is located in the analyzer unit, running horizontally over the reagent disks. With its gripper arm, the mechanism transfers reagent packs to and from the reagent disks and to the unloading tray.
Unloading tray After usage, the gripper transfers the reagent packs from the reagent disks to the unloading tray where you can take them out.
Roche Diagnostics
Operator’s Manual · 4.2.1
145
6 cobas c 702 module
Top view
Control panel cobas® 8000 modular analyzer series
The control panel is the interface of the reagent manager. The four buttons on the panel allow you to select the loading mode (Buffering or Direct) and, when necessary, a particular target disk (A or B) for the reagent packs you are loading.
A B C D
E F G
A Button for disk A (Direct mode)
B Auto button (Direct mode)
C Buffer button (Buffering mode)
D Button for disk B (Direct mode)
Figure 6-6
E Status LED: Calibration
F Loading port and status LED
G Return port and status LED
Control tower of the reagent manager
Loading modes
Mode
Buffering
Direct
Table 6-1
Button Description
BUFFER The reagent pack remains on the buffer rotor until needed.
The system decides about loading time and target reagent disk.
AUTO
A or B
Loads the reagent pack as soon as possible. The target reagent disk is assigned by the system.
If the module is in Standby, the reagent is loaded immediately.
During operation, the reagent is loaded when the status changes to Reagent Loading (S.Stop).
Loads the reagent pack as soon as possible to disk A or B.
If the module is in Standby, the reagent is loaded immediately.
During operation, the reagent is loaded when the status changes to Reagent Loading (S.Stop).
Loading modes q The selected loading mode remains active until another mode is selected.
u
For details on loading reagent packs, see Replacing reagent packs (cobas c 702 module)
Roche Diagnostics
146
Calibration status A yellow LED in the lower area of the panel indicates whether a reagent pack in the buffer rotor is recommended to be calibrated. If this LED is on, check the Reagent
Manager Overview window.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Loading port
6 cobas c 702 module
Top view
The loading port allows continuous loading of reagent packs whether the module is in Standby or Operation mode as long as the green LED is on.
A B C
D
Buffer rotor
Roche Diagnostics
Operator’s Manual · 4.2.1
A Shutter in front of the loading port
B Buffer rotor (inside tower)
Figure 6-7 Loading port
C Status LED: Loading port
D Reagent preparation table
When the sensor at the loading port detects a reagent pack, the shutter opens and the pack is drawn in automatically. When 10 seconds have passed since the last loading of a pack or when the buffer rotor is full, the reagent manager switches to the transfer session and the green LED turns off. During the transfer session, reagent packs are loaded onto the reagent disks. After completion of the transfer session, the port becomes available again for loading.
q o Be sure to place a reagent pack with its test name on the label facing left.
o If a reagent pack is inserted the wrong way round, it will not be drawn into the autoloading system. The LED at the loading port is blinking.
o Do not push a reagent pack against the shutter. Do not tilt a reagent pack.
The reagent preparation table, which is located at the front, allows you to place up to seven reagent packs.
The reagent buffer rotor inside the control tower can accommodate a maximum of ten reagent packs. The reagent packs remain in the buffer rotor or are loaded directly depending on to the loading mode you have chosen.
Each cobas c pack large is equipped with an RFID label (Radio Frequency
IDentification). The RFID label is read while the reagent pack is loaded onto the buffer rotor.
q If a reagent pack is used for measurement whose reagent manager on-board stability has expired for more than 30 minutes while staying in the buffer rotor, a data alarm (OBS.RM) is attached to the results.
147
6 cobas c 702 module
Top view
Transfer mechanism
NOTICE cobas® 8000 modular analyzer series
The transfer mechanism is located in the analyzer unit, running horizontally over reagent disks A and B. A gripper arm, which is mounted on x-y motion mechanisms, picks up and transfers reagent packs to their destination. The cover over each reagent disk has an automated flap door to allow entry and exit of reagent packs.
Damage to the transfer mechanism for reagent packs (c 702 only)
Excessive weight on the transfer mechanism may lead to damage.
r Do not lean on the transfer mechanism for reagent packs.
r
Observe in particular the following safety label on the instrument: T-3 (p. 38).
q In case of operation was interrupted
If the system has stopped during operation for some reason and the gripper arm is positioned elsewhere, you may need to move the gripper arm to the leftmost or rightmost position by hand before executing a reset. Otherwise, the module will not resume operation and an alarm will be issued.
Unloading tray
Reagent packs that were selected for unloading are transferred from the reagent disks to the unloading tray. The selection can be made either automatically by the system
(e.g., empty reagent packs) or manually by the operator.
The hatch door at the front of the module allows access to the tray without opening the top cover.
Roche Diagnostics
148
A B
A Hatch door in front of the unloading tray
C
B Status LED: Access to unloading tray
C Status LED: Filled reagent packs
Figure 6-8 Unloading tray
The tray has two lanes and its total capacity is 12 packs. Both lanes can be used for empty packs, but only the right lane is used for packs that still contain reagent. So if there are filled reagent packs in the right lane, empty packs are collected only in the left lane.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 6 cobas c 702 module
Top view
LED lights There are two LED indicator lights in the area under the hatch door: o
The green LED on the left indicates if the unloading tray is accessible. o
The yellow LED on the right indicates if a reagent pack on the right lane of the tray still contains reagent.
Unloading reagent packs The unloading tray is of the drawer type and you must open it to remove reagent packs. Once the tray is completely open, the system resets the inventory of reagent packs present on the tray.
Additionally, you can manually unload specific reagent packs to the tray via the user interface ( Reagent > Setting > R. Pack Unloading ).
q o Be sure to pull the tray forward all the way to take out reagent packs. Otherwise, the system will not reset the inventory of reagent packs present on the tray.
o Current data (such as on-board stability status) are written on the RFID label of the reagent pack being unloaded.
u
For information on unloading reagent packs, see:
To take out automatically unloaded reagent packs from the unloading tray (p. 373)
Return port
The return port is used if a reagent pack must be ejected from the buffer rotor for some reason. It is also possible to eject a reagent pack manually via the user interface.
A B C
Roche Diagnostics
Operator’s Manual · 4.2.1
A Cap waste box B Status LED: Return port
C Return port
Figure 6-9 Return port
To remove a reagent pack from the return port, you have to open the transparent cover. The yellow LED beside the port indicates if there is a reagent pack at the return port.
149
6 cobas c 702 module
Top view
Cap waste box
WARNING
NOTICE cobas® 8000 modular analyzer series
Immediately before the reagent pack is transferred to a reagent disk, the caps are automatically removed from the packs.
The cap waste box is located at the lower left side of the control tower. Removed caps are collected in this box. Be sure to empty the box periodically before it gets full. The box has a capacity of approximately 100 reagent caps.
u
See To empty the cap waste box (p. 376).
q o A yellow alarm is issued when the cap waste box becomes 80% full. If the box is full, a red alarm is displayed and the module stops.
o Be sure to press the reset button in the user interface after emptying the waste box.
Skin inflammation or injury caused by reagent residue on reagent caps
Direct contact with assay reagents or detergents may cause skin irritation or inflammation.
r Empty the cap waste box periodically. Do not let its contents overflow or reagent spill over.
r Exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as gloves).
Damage to the instrument due to reused reagent caps
Reused caps may not be properly handled by the uncapping mechanism. When a temporarily stored reagent pack is loaded again, reused caps may come off accidentally and become stuck in the mechanism.
r Never reuse a reagent cap from the waste box.
Backup operation port
The backup port for loading sample racks is located under the preparation table. To access the backup port, detach the preparation table by unfastening the black retaining screw.
Roche Diagnostics
150
A
B
C
A Preparation table
B Retaining screw
Figure 6-10
C Backup operation port for manual rack supply
Backup operation port below preparation table
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series u
For information on backup operation, see:
Reaction disk area
6 cobas c 702 module
Top view
The reaction disk area of the module consists of the following components: o
A reaction disk with the reaction cells, which are immersed in the incubator bath.
o
Six ultrasonic mixing units for non-contact mixing of reaction mixtures.
o
A photometric measuring system which continually measures the absorbance of the reaction mixture in each of the reaction cells.
o
Three cell rinse units for cleaning the reaction cells once a test measurement is complete.
o
An Ecotergent reagent pack in the right reagent disk (B). Ecotergent is an additive for the incubator bath.
The following figure presents the major parts of the reaction disk.
D E F
A B
C
A Incubator bath
B Reaction cell – an individual segment
C Ultrasonic mixers
Figure 6-11
D
E
Cell rinse unit 3
Cell rinse unit 2
Reaction disk – c 702
F Cell rinse unit 1
G Photometer lamp
G
Roche Diagnostics
Operator’s Manual · 4.2.1
151
6 cobas c 702 module
Top view
Reaction disk cobas® 8000 modular analyzer series
The reaction disk of the c 702 module carries 406 reusable plastic reaction cells (also called cuvettes ). These reaction cells are grouped together in 14 segments with 29 cells each. All reaction cells are seated in a temperature-controlled bath. This incubator bath maintains the cells at the required temperature of 37 °C (98.6 °F).
q The reaction cells should be replaced once a month since they gradually deteriorate over long use. Carry out cell blank measurement once a week after rinsing the reaction system to check the integrity of all cells.
u
See To perform a cell blank measurement (p. 703).
Ultrasonic mixers
The ultrasonic mixing units mix the reagents within each of the reaction cells to ensure a homogeneous distribution between sample and reagent fluid.
Corresponding to the three reagent timings R1, R2, and R3, there are independent mixing units.
To avoid any spillage, the filling level of the incubator bath is checked before the mixing process starts. If the liquid level is too low, an alarm (MIXSTP) is issued and mixing is not performed.
Contamination on the surface of the ultrasonic mixing units will cause inadequate mixing. The surface should be cleaned at least once every three months.
The ultrasonic output intensity is continually monitored. If the intensity level falls below a certain limit, an alarm (MIXLOW) is issued and replacement of the ultrasonic mixing pack is required. Contact your technical support for replacement.
u
For more information, see Cleaning the ultrasonic mixers (p. 729).
Incubator bath
The figure shows the reaction cuvette segment shortly before passing the photometer windows.
The circular incubator bath is filled with temperature controlled water. The analyzer controls the temperature of the incubator bath water and keeps the reaction solution at a temperature of 37 °C (± 0.1 °C) (98.6 °F (±0.18 °F)).
Two glass windows (inner and outer) are positioned in opposite walls of the incubator bath. These windows permit light from the photometer lamp to pass through the incubator bath water and through the reaction cells in the bath. The light beam emerges from the outer window of the incubator bath and enters the instrument photometer.
A liquid level sensor detects the water level of the bath. Deionized water is automatically added to the incubator bath, as determined by the liquid level sensor, to compensate for evaporation. This occurs even in Standby.
Ecotergent Ecotergent is a non-ionic detergent for the incubator bath. It acts as a surfactant to minimize the formation of bubbles that could interfere with the photometer readings.
Ecotergent is automatically added to the incubator bath whenever the water is exchanged. Ecotergent is the substitute product to the previously used Hitergent.
u
For information on the consumption of Ecotergent, see:
Consumption of Ecotergent (p. 714).
Roche Diagnostics
152 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Photometer
6 cobas c 702 module
Top view
The small figure shows the photometer lamp (cover opened).
The photometer measures the absorbances of the reaction mixtures in the reaction cells. Measurements are taken of each reaction cell, as the reaction ring is turning.
The figure below illustrates the functional principle of the light beam from the photometer to the detector.
A B C D E F G H I J K L M
N
A Photometer lamp
B Water jacket
C Infrared cut filter
D Mask
E Condenser lens
Figure 6-12
I
F
G
H
J
Slit (IN)
Incubator bath
Reaction cell and dispersion
Slit (OUT)
Imaging lens
K Slit
L Photometer unit
M
N
Diffraction grating
Detector
Illustration of light path through photometer components
Photometer lamp The photometer lamp is accommodated in a water-cooled case. This design ensures a constant energy output from the lamp and it also extends the lamp life.
u
For more information about replacing the photometer lamp, see
Replacing the photometer lamp (p. 733).
Light path The light from the photometer lamp passes through the following main components: o
First incubator bath window o Incubator bath water o
Reaction cell and its contents o Incubator bath water o
Second incubator bath window o and, finally, into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This separates the light into its individual wavelengths and reflects them onto a fixed array of 12 photodiodes. Each photodiode is mounted in a fixed position to detect light at an individual wavelength.
Roche Diagnostics
Operator’s Manual · 4.2.1
153
6 cobas c 702 module
Top view cobas® 8000 modular analyzer series
The control unit uses the available assay parameter information to select the wavelengths and the times at which a reaction mixture's absorbance is read and results are calculated.
The control unit keeps track of which test is being performed in each reaction cell. It also knows when each reaction cell passes through the photometer light path. After measurements are completed, the control unit calculates the test results from the measured absorbance values.
Cell rinse units
3
2
1
The cell rinse units are located to the right and at the back of the reaction disk. They clean, rinse, and dry the reaction cells after the absorbance was measured.
To ensure reaction cell optical performance, the absorbance values of water-filled reaction cells are measured during the cleaning process (cell blank) and compared with the stored value from the weekly cell blank measurement. The cell blank guarantees the condition of all reaction cells within small tolerances. If any individual cell does not meet these predefined limits, it is disabled for routine use.
Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and drying of the reaction cells takes place.
5RWDWLRQDOGLUHFWLRQRIWKHUHDFWLRQULQJ
A B C D
5LQVHXQLW
G H I J K L
&HOOEODQN
PHDVXUHPHQW
M N
5LQVHXQLW 5LQVHXQLW
A D F I L C E H K N B G J M
A Liquid aspiration at the end of a reaction
B Rinse water discharge
C Rinse water aspiration
D Cell cleaner 1 discharge
E Cell cleaner 1 aspiration
F Cell cleaner 2 discharge
G Cell cleaner 2 aspiration
Figure 6-13 Cell rinse and clean functions
H Rinse water discharge
I Rinse water aspiration
J Rinse water discharge
K Rinse water aspiration and drying
L Water blank discharge
M Water blank aspiration
N Water blank aspiration and drying
Roche Diagnostics
154 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 6 cobas c 702 module
Top view
Nozzle functions The nozzle shape is designed according to the intended function. Presented below is an overview of nozzles and their functions:
A B C
A Aspiration of liquids
Figure 6-14
B Discharging and aspiration of liquids
C Reaction cell drying
Nozzle functions
The Teflon® tip of shape C is optimized for perfect drying of the reaction cell.
Roche Diagnostics
Operator’s Manual · 4.2.1
155
6 cobas c 702 module
Top view cobas® 8000 modular analyzer series
Workflow of photometric analysis
The workflow presented below illustrates a single measurement sequence:
6WDUW
&OHDQLQJWKHUHDFWLRQFHOO
&HOOEODQNPHDVXUHPHQW
'LVSHQVLQJRIVDPSOH
$GGLQJUHDJHQWV
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
&DOFXODWLQJWKHUHVXOW
&OHDQLQJWKHUHDFWLRQFHOO
$XWRPDWLF6723
(QG
Figure 6-15 Workflow of a measurement sequence
The following table gives a detailed description of the measurement workflow.
Description of a measurement sequence
1
2
Cleaning the reaction cell
Cell blank measurement
After start, mechanical parts are reset to their home positions. Then the instrument starts rinsing the reaction cell. The reaction disk rotates continuously. The rinsing nozzle (
aspirates reaction mixture from the reaction cell. A few cycles later, the reaction cell is washed with deionized water using rinsing nozzles (
/
In the next step, the reaction cell is washed with rinsing nozzles (
mechanism using CellCln 1. Thereafter, the reaction cell is washed with rinsing nozzles
(
F / G ) in the rinsing mechanism using CellCln 2. Using the rinsing nozzles ( H
/
reaction cell is rinsed with deionized water. The cell is rinsed a second time with deionized water with nozzles (
The rinse nozzle (
L ) dispenses a water blank discharge. A cell blank value is measured
3 times. If the cell blank value differs by 0.1 absorbance values (Abs) or more from the stored value from the weekly cell blank measurement, this cell will not be used for analysis.
3
Dispensing of sample
Table 6-2
After rinsing and cell blank measurement are done, the reaction cell returns to the sampling position and dispensing of sample starts.
Every 1.8 seconds, a test sequence is initiated alternating between sample probe A and B.
Workflow of a measurement sequence
Roche Diagnostics
156 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 6 cobas c 702 module
Top view
Description of a measurement sequence
4
Adding reagents Reagents R1, R2, and R3 are added at the determined positions and time points (0, 2 and
5 minutes). Every time one of the reagents R1, R2, and R3 is added, the fluid in the cell is mixed at the corresponding mixing position by means of the ultrasonic mixer.
16.2 s - photometric cycle time 1.8 s - sampling time 3.6 s - sampling time per sample probe
(A or B)
5
Calculating result Sampling is carried out every 1.8 seconds. Measurement is performed 38 times/cell in
10 minutes. After all measurements are completed, the concentration is calculated using the absorbance at the specified points of the reaction process.
6
Cleaning the reaction cell The instrument aspirates the reaction solution using the cell rinse units and performs the wash sequence with detergent followed by rinsing with water.
7
Automatic stop
Table 6-2
The instrument goes into Standby if the Rack Reception Mode is not activated.
Workflow of a measurement sequence
Roche Diagnostics
Operator’s Manual · 4.2.1
157
6 cobas c 702 module
Front view
Front view
cobas® 8000 modular analyzer series
This section presents all elements which are located behind the front doors.
A B
C D E F
A Components used for maintenance
B Filter of solenoid valve
C Syringes
Figure 6-16
D Cooling unit
E Detergent bottles (CellCln 1 and CellCln 2)
F Drain ports for condensation water in the vacuum system
Components behind the front doors
Components used for maintenance These controls and status LED are used for maintenance only.
Filter of solenoid valve The filter of the solenoid valve unit prevents dirt and dust being mixed into the unit when the valve opens up for air.
Syringes These syringes are in charge of transporting reagent and sample liquid.
Cooling unit The cooling unit is used to maintain a constant temperature of the incubator bath and to cool the reagent packs.
Detergent bottles These bottles are filled with detergents for the cell rinse process.
Drain ports These two ports are used to drain the two tank compartments of the vacuum system.
Roche Diagnostics
158 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Maintenance controls
6 cobas c 702 module
Front view
A B C
A Control LEDs
B Maintenance tap
Figure 6-17
C Push buttons F1 and F2
Components used during maintenance
Control LEDs These LEDs show the status of the individual internal power supplies. The green color indicates, that all power supplies are working properly.
Maintenance tap This tap is used to drain the incubator bath during maintenance.
Push buttons F1 and F2 The button F1 is used for maintenance purposes. The function of the button F1 changes, depending on the selected maintenance item. It can be used, for example: o
To start the re-filling of the incubator bath.
o
To start moving the rinse nozzles up and down into a reaction cuvette in order to check the correct position of the nozzle tip.
o
To move the reagent probes horizontally.
The button F2 is used for service purposes only.
Roche Diagnostics
Operator’s Manual · 4.2.1
159
6 cobas c 702 module
Front view
Syringes
cobas® 8000 modular analyzer series
The syringes are used to control the pipetting actions of the different probes. The probes are connected to the syringe by tubing.
The syringes are filled with degassed and deionized water, using positive displacement to aspirate and dispense solutions via the corresponding probes.
A B
A R1 syringe - disk A
B R2/R3 syringe - disk A
C R1 syringe - disk B
Figure 6-18 Location of syringes
C D E
D R2/R3 syringe - disk B
E Sample syringe - pipetter A
F Sample syringe - pipetter B
F
Reagent syringes The R1 syringe aspirates the determined volume of reagent R1 and discharges it into a reaction cell.
The R2/R3 syringe aspirates the determined volume of reagent R2/R3 and discharges it into a reaction cell, also according to the test setup.
Sample syringe A sample syringe aspirates the determined volume of sample and discharges it into a reaction cell. A pressure sensor between the probe and the pipetter monitors the sample-aspirating state and detects clots.
Roche Diagnostics
160 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Detergents and filter
6 cobas c 702 module
Front view
A
A Filter of cooling unit
B
B Cell cleaner 1 (CellCln 1)
C Cell cleaner 2 (CellCln 2)
C
Figure 6-19 Filter and detergent bottles
Filter of cooling unit The radiator of the cooling unit is equipped with a dust filter that must be cleaned in course of regular maintenance.
Detergent bottles The two large bottles located behind the front door of the module contain detergents for cleaning purposes. Cell cleaner 1 is a basic detergent and Cell cleaner 2 is an acid detergent.
Vacuum system
The vacuum system is located behind the front of the module. It consists of vacuum pumps, vacuum tanks, vacuum sensors, and connecting tubing.
The vacuum system aspirates reaction mixture waste from the reaction cells to the reaction waste container and removes reaction cell rinse water from the module through the main drain line.
The vacuum system must be checked routinely as part of the maintenance.
u
To locate the drain ports of the vacuum system, see figure 6-16, p. 158.
Roche Diagnostics
Operator’s Manual · 4.2.1
161
6 cobas c 702 module
Rear view
Rear view
The module as seen from the rear side.
cobas® 8000 modular analyzer series
E
F
G
A Outlet for diluted waste
B Outlet for highly concentrated waste
C Liquid level sensor assembly
D Water tank
Figure 6-20 c 702 rear view
A B C D
E Water inlet
F Power circuit breaker
G Power inlet
Diluted waste Main drain outlet - connected to a drain pipe.
Highly concentrated waste Outlet for highly concentrated waste. This waste must be treated as infectious waste according to the local regulations.
q o Further handling of concentrated waste solution depends on the facilities of the laboratory. Some laboratories use containers; others may connect hoses leading to their drainage system. o When using waste containers, always make sure that the container is present and empty at the beginning of daily analysis.
Liquid level sensor assembly Water tank cap with a float for the integrated level control.
Water tank This tank buffers peak water consumptions during routine work.
Water inlet Main water supply.
Power inlet The mains supply of the module is connected here.
Power circuit breaker The power circuit breaker provides protection in case of an internal electrical short. It is also used to switch the module on or off, for example when performing manual maintenance.
Roche Diagnostics
162 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
cobas c 502 module
7 cobas c 502 module
7
Roche Diagnostics
Operator’s Manual · 4.2.1
This chapter provides a detailed description of the c 502 module, its hardware components and technical specifications.
In this chapter
Chapter
7
163
7 cobas c 502 module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
164 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
7 cobas c 502 module
Overview
The c 502 module is a fully automated, discreet, computerized analyzer for in vitro tests on a wide range of analytes. The c 502 module performs photometric assays. The throughput is up to 600 tests per hour. The related module sample buffer offers a random access buffer function for samples.
A
A Module sample buffer
Figure 7-1 c 502 module
B
B c 502 module
Components of the cobas c 502 module o
The c 502 module can be subdivided into the following areas:
Sampling area u
See
o
Reagent area u
See
o
Reaction disk area u
See
o
Components behind the front doors u
See
o
Components at the rear side of the module u
See
Roche Diagnostics
Operator’s Manual · 4.2.1
165
7 cobas c 502 module
Top view
Top view
cobas® 8000 modular analyzer series
The figure below shows the top view of the module.
A
B
C
A Sampling area
B Reaction disk area
Figure 7-2 Areas of the c 502 module
C Reagent area
D Reagent pack loading port
The top of the module includes the sampling, reagent, and reaction disk areas. The following sections describe these areas.
D
Roche Diagnostics
166 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Sampling area
7 cobas c 502 module
Top view
The sampling area is in charge of transporting sample fluid between a sample tube and an individual reaction cuvette.
The sampling area of the c 502 module consists of the following components: o
A rack sampling position o
A sample pipetter o
A rinse station for internal and external rinsing of the sample probe
A B C
D
E
F
G
H
A Sample pipetter
B Shield pipe (against electrostatic noise)
C Sample probe
D Drying position
Figure 7-3 Sample pipetting system
E Rinse station
F Flushing canal
G 2 - Sample Cleaner 2
H 1 - Sample Cleaner 1
Sample pipetter A sample pipetter aspirates sample liquid from sample tubes and pipettes it into reaction cells.
Rinse station The rinse station cleans the inside and outside of the probes after an individual sample has been processed. This prevents any carryover between individual samples.
Sample Cleaner 1 Is used as basic cleaning solution.
Sample Cleaner 2 Is used as acid cleaning solution.
Roche Diagnostics
Operator’s Manual · 4.2.1
167
7 cobas c 502 module
Top view cobas® 8000 modular analyzer series
Sample pipetter
A sample pipetter consists of the pipetter arm and the sample probe. When a rack is in the sampling position, the pipetter transports sample from the sample tube to a reaction cell. When aspirating, liquid level detection is accomplished by highly sensitive capacitance measurement, and clot detection by means of pressure measurements.
To protect the probe against electrostatic noise, which could interfere with the capacitance measurement, a metal shield pipe is mounted over the sampling position.
After sample has been aspirated, the probe is raised from the sample and is moved to the reaction disk. The sample probe arm lowers the probe into the reaction cell at the sample dispense position. Sample is dispensed while the beveled sample probe tip is in contact with the bottom of the reaction cell. This ensures that a precise volume of sample is deposited into the bottom of the cell even when using a low dispense volume. The sample probe is spring-mounted on the arm to avoid damage to the probe or reaction cell.
Sample probe rinse station
The sample probe rinse station is located between the sample aspiration position and the reaction disk. To prevent carryover, the sample probe is rinsed with deionized water both externally and internally before aspirating a new sample.
q The sample probe stops at the drying cylinder only when whole blood is pipetted for
HbA1c tests.
The rinse station is also the home position for the sample probe when the pipetter is in Standby.
Roche Diagnostics
168 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 7 cobas c 502 module
Top view
Reagent area
Reagent storage compartment
The reagent area is in charge of transporting reagents to individual reaction cuvettes.
The reagent area of this module consists of the following components: o
A refrigerated reagent compartment for storing up to 60 reagent packs
( cobas c packs) o
Two reagent pipetters for aspirating and dispensing reagents o
Two rinse stations for internal and external rinsing of the reagent probes
A
B
C
D
E
A Reagent preparation station
B Reagent compartment flap
C Cutouts for R1 reagent pipetter probe
Figure 7-4
D
E
Reagent compartment
Cutouts for R2 reagent pipetter probe c 502 reagent storage compartment
Reagent packs are stored in a closed, temperature-controlled (5–12 °C) compartment containing two concentric rings with a total of 60 positions for reagent packs. There are 24 positions on the inner and 36 positions on the outer ring.
Opening and closing of the reagent compartment flap is controlled by the system on its own. Do not try to open this flap manually! Reagent packs are placed into and removed via the compartment flap.
Round cutouts in the cover allow reagent probes to access the reagents.
Roche Diagnostics
Operator’s Manual · 4.2.1
169
7 cobas c 502 module
Top view
Reagent pipetters cobas® 8000 modular analyzer series
The reagent pipetting system is composed of two reagent pipetters—R1 and R2—and two reagent syringes. The pipetters are mounted on two independent x-y-motion mechanisms.
A B
C
D
A R2 pipetter
B R1 pipetter
Figure 7-5 Reagent pipetters
C Gripper
D Rinse stations
The reagent pipetters transport the reagents from the reagent compartments to the reaction disk.
Before each pipetting, the reagent probes are externally and internally rinsed with deionized water. After reagent has been aspirated, the probe moves from the reagent compartment to the reaction disk. There, the reagent volume is dispensed into a reaction cell containing the sample. Unlike the sample probe, the reagent probe is not lowered into the reaction cell. Reagent is dispensed from the top of the reaction cell.
The mechanical cycle of the module allows for three different reagent timings: R1, R2, and R3. The R1 pipetter pipettes reagents at R1 timing. The R2 pipetter pipettes reagents at R2 and R3 timings.
Only the R1 reagent probe is equipped with a level detector. This detector works with a pressure sensor and can be used to check the reagent volume for newly loaded reagents (ICVC check). By default, a liquid level detection is performed.
The R1 reagent probe, the gripper and the piercer are mounted on the same XYtransport.
u
For more information, see:
Reagent pack preparation station (p. 172)
Reagent concept (cobas c 502 module) (p. 381)
Reagent probe rinse stations The reagent probe rinse stations are located between the reagent compartment and the reaction disk.
Roche Diagnostics
170 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 7 cobas c 502 module
Top view
After each reagent dispense, deionized water is flushed through the probes and onto their outside surfaces.
The rinse stations are the home position for the reagent probes when the module is in
Standby.
Reagent pack management system
Reagents for all Roche Diagnostics applications on the c 502 module are provided in reagent packs. These reagent packs contain two or three specially designed reagent containers. Each reagent pack has a barcode label which is encoded with reagent and test related information.
From the time of check-in until an empty reagent pack is discharged, the c 502 automatically manages the registration and internal transportation of each reagent pack. This rules out any possibility of misplacement or usage of inappropriate reagents.
The reagent pack management system consists of the following components: o
Reagent pack loading port o
Reagent pack preparation station o
Piercer and gripper o
Reagent pack disposal
A B
C
A Reagent pack loading port
Figure 7-6
B Reagent pack table - turned down
Components of the reagent pack management system
C Reagent pack disposal port
Reagent pack loading port The reagent pack loading port is located behind the reagent pack table at the front of the c 502 module. It is used for loading reagent packs.
Roche Diagnostics
Operator’s Manual · 4.2.1
171
7 cobas c 502 module
Top view cobas® 8000 modular analyzer series
When loading a reagent pack, it is important that its barcode label is facing to the right .
After loading, the system handles the reagent pack without any further intervention of the operator: The reagent pack is pulled in to the preparation station where a barcode reader scans the reagent pack's barcode label and checks its integrity.
q A reagent pack is rejected and not loaded but pushed out of the loading port again in the following cases: o The reagent pack barcode is unreadable.
o The reagent pack has been on the analyzer before and it was previously dumped
(discarded) by the system.
Reagent pack preparation station The reagent pack preparation station is located directly behind the reagent pack loading port. When a new reagent pack is pulled in to the preparation station, a barcode reader scans the following data from the reagent pack's barcode label: o
Reagent pack ID (for example: 0737550) o Lot number o
Reagent pack number (sequence number, for example, 01983)
In case the reagent pack has been registered before, the reagent compartment flap opens and the gripper loads the reagent pack.
If the current reagent pack is new, the instrument checks the availability of the corresponding test application and the piercer punctures the reagent bottle caps.
u
For more information about reagents and registration of reagents, see
Reagent concept (cobas c 502 module) (p. 381).
Piercer and gripper The piercer and gripper are mounted—together with the R1 pipetter—on a XYZtransport. The reagent pack is ready for transportation after the piercer has punctured the container caps in the reagent pack. The gripper takes the reagent pack into the reagent compartment.
Injury or damage to the analyzer due to contact with instrument mechanism r Do not touch the piercer or the gripper during instrument operation.
CAUTION
Reagent pack disposal Empty reagent packs are automatically transported to the reagent pack disposal. With the aid of gravity, the reagent packs drop down the reagent pack disposal shaft at the end of which they can be removed by the operator. The reagent pack disposal has a capacity of 10 reagent packs.
u
To locate the reagent pack disposal, see figure 7-6, p. 171.
Roche Diagnostics
172 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reaction disk area
7 cobas c 502 module
Top view
The reaction disk area of the module consists of the following components: o
A reaction disk with the reaction cells, which are immersed in the incubator bath.
o
Three ultrasonic mixing units for non-contact mixing of reaction mixtures.
o
A photometric measuring system which continually measures the absorbance of the reaction mixture in each of the reaction cells.
o
A cell rinse unit for cleaning the reaction cells once a test measurement is complete.
o
A separate pipetter and a Ecotergent bottle. Ecotergent is an additive for the incubator bath.
The following figure presents the major parts of the reaction disk.
H
A
I
B
Reaction disk
Roche Diagnostics
Operator’s Manual · 4.2.1
C
A Reaction disk rotor
B Reaction cell – an individual segment
C Interlock unit
D Ecotergent bottle
E Pipetter for Ecotergent
Figure 7-7 Reaction disk – c 502
D E F G
F Photometer lamp
G Incubator bath
H Water level sensor
I Ultrasonic mixers
The reaction disk of the c 502 module carries 160 reusable plastic reaction cells (also called cuvettes ). These reaction cells are grouped together in eight segments with
20 cells each. All reaction cells are seated in a temperature-controlled bath. This incubator bath maintains the cells at the required temperature of 37 °C (98.6 °F).
q The reaction cells should be replaced once a month since they gradually deteriorate over long use. Carry out cell blank measurement once a week after rinsing the reaction system to check the integrity of all cells.
u
See To perform a cell blank measurement (p. 703).
173
7 cobas c 502 module
Top view
Ultrasonic mixers cobas® 8000 modular analyzer series
The ultrasonic mixing units mix the reagents within each of the reaction cells to ensure a homogeneous distribution between sample and reagent fluid.
Corresponding to the three reagent timings R1, R2, and R3, there are independent mixing units.
To avoid any spillage, the filling level of the incubator bath is checked before the mixing process starts. If the liquid level is too low, an alarm (MIXSTP) is issued and mixing is not performed.
Contamination on the surface of the ultrasonic mixing units will cause inadequate mixing. The surface should be cleaned at least once every three months.
The ultrasonic output intensity is continually monitored. If the intensity level falls below a certain limit, an alarm (MIXLOW) is issued and replacement of the ultrasonic mixing pack is required. Contact your technical support for replacement.
u
For more information, see Cleaning the ultrasonic mixers (p. 729).
Incubator bath
The figure shows the reaction cuvette segment shortly before passing the photometer windows.
The circular incubator bath is filled with temperature controlled water. The analyzer controls the temperature of the incubator bath water and keeps the reaction solution at a temperature of 37 °C (± 0.1 °C) (98.6 °F (±0.18 °F)).
Two glass windows (inner and outer) are positioned in opposite walls of the incubator bath. These windows permit light from the photometer lamp to pass through the incubator bath water and through the reaction cells in the bath. The light beam emerges from the outer window of the incubator bath and enters the instrument photometer.
A liquid level sensor detects the water level of the bath. Deionized water is automatically added to the incubator bath, as determined by the liquid level sensor, to compensate for evaporation. This occurs even in Standby.
Ecotergent Ecotergent is a non-ionic detergent for the incubator bath. It acts as a surfactant to minimize the formation of bubbles that could interfere with the photometer readings.
Ecotergent is automatically added to the incubator bath whenever the water is exchanged. Ecotergent is the substitute product to the previously used Hitergent.
u
For information on the consumption of Ecotergent, see:
Consumption of Ecotergent (p. 714).
Roche Diagnostics
174 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
A
B
C
A Ecotergent probe
B Rinse station for detergent probe
Figure 7-8
C Ecotergent bottle
Pipetter probe for the incubator bath detergent
7 cobas c 502 module
Top view
Roche Diagnostics
Operator’s Manual · 4.2.1
175
7 cobas c 502 module
Top view
Photometer cobas® 8000 modular analyzer series
The photometer measures the absorbances of the reaction mixtures in the reaction cells. Measurements are taken of each reaction cell, as the reaction ring is turning.
The figure below illustrates the functional principle of the light beam from the photometer to the detector.
A B C D E F G H I J K L M
Roche Diagnostics
176
N
A Photometer lamp
B Water jacket
C Infrared cut filter
D Mask
E Condenser lens
Figure 7-9
I
F
G
H
J
Slit (IN)
Incubator bath
Reaction cell and dispersion
Slit (OUT)
Imaging lens
K Slit
L Photometer unit
M
N
Diffraction grating
Detector
Illustration of light path through photometer components
Photometer lamp The photometer lamp is accommodated in a water-cooled case. This design ensures a constant energy output from the lamp and it also extends the lamp life.
The photometer lamp is located against the inner ring of the incubator bath beneath the reaction disk. The detector is outside of the incubator bath ring just in opposite position of the lamp.
u
To locate the photometer unit, see figure 7-7, p. 173.
u
For more information about replacing the photometer lamp, see
Replacing the photometer lamp (p. 733).
Light path The light from the photometer lamp passes through the following main components: o First incubator bath window o
Incubator bath water o Reaction cell and its contents o
Incubator bath water o Second incubator bath window o and, finally, into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This separates the light into its individual wavelengths and reflects them onto a fixed array of 12 photodiodes. Each photodiode is mounted in a fixed position to detect light at an individual wavelength.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 7 cobas c 502 module
Top view
The control unit uses the available assay parameter information to select the wavelengths and the times at which a reaction mixture's absorbance is read and results are calculated.
The control unit keeps track of which test is being performed in each reaction cell. It also knows when each reaction cell passes through the photometer light path. After measurements are completed, the control unit calculates the test results from the measured absorbance values.
Cell rinse unit
The cell rinse unit is located to the left of the reaction disk. It cleans, rinses, and dries the reaction cells after the absorbance was measured.
To ensure reaction cell optical performance, the absorbance values of water-filled reaction cells are measured during the cleaning process (cell blank) and compared with the stored value from the weekly cell blank measurement. The cell blank guarantees the condition of all reaction cells within small tolerances. If any individual cell does not meet these predefined limits, it is disabled for routine use.
A
B
A Cell rinse unit
Figure 7-10 Reaction cell rinsing system
B Cell rinse nozzles
Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and drying of the reaction cells takes place.
Roche Diagnostics
Operator’s Manual · 4.2.1
177
7 cobas c 502 module
Top view cobas® 8000 modular analyzer series
5RWDWLRQDOGLUHFWLRQRIWKHUHDFWLRQULQJ
A B C D E F G
&HOOEODQN
PHDVXUHPHQW
H I
5LQVHXQLW
G F E D C B A H I
A Liquid aspiration at end of reaction
Rinse water discharge
B Rinse water aspiration
Cell Cleaner 1 discharge
C Cell Cleaner 1 aspiration
Cell Cleaner 2 discharge
D Cell Cleaner 2 aspiration
Rinse water discharge
E Rinse water aspiration
Rinse water discharge
F Rinse water aspiration
G Water blank discharge
Water blank overflow aspiration
H Water blank aspiration (nozzle tip)
I Water blank aspiration (nozzle tip)
Figure 7-11 Flow of the cell rinse mechanism
Nozzle functions The nozzle shape is designed according to the intended function. Presented below is an overview of nozzles and their functions:
Roche Diagnostics
178
A B C
A Aspiration of liquids
Figure 7-12
B Discharging and aspiration of liquids
C Reaction cell drying
Nozzle functions
The Teflon® tip of shape C is optimized for perfect drying of the reaction cell.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 7 cobas c 502 module
Top view
Workflow of photometric analysis
The workflow presented below illustrates a single measurement sequence:
6WDUW
&OHDQLQJWKHUHDFWLRQFHOO
&HOOEODQNPHDVXUHPHQW
'LVSHQVLQJRIVDPSOH
$GGLQJUHDJHQWV
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
$GGLQJ5PL[LQJ
&DOFXODWLQJWKHUHVXOW
&OHDQLQJWKHUHDFWLRQFHOO
$XWRPDWLF6723
(QG
Figure 7-13 Workflow of a measurement sequence
The following table gives a detailed description of the measurement workflow.
Description of a measurement sequence
1
2
Cleaning the reaction cell
Cell blank measurement
After start, mechanical parts are reset to their home positions. Then the instrument starts rinsing the reaction cell. The reaction disk rotates continuously. The rinsing nozzle (
aspirates reaction mixture from the reaction cell. A few cycles later, the reaction cell is washed with deionized water.
In the next step, the reaction cell is washed with rinsing nozzle (
), the reaction cell is rinsed with deionized water. The cell is rinsed a second time with deionized water with nozzles (
/
The rinse nozzle (
) dispenses a water blank discharge. A cell blank value is measured
3 times. If the cell blank value differs by 0.1 absorbance values (Abs) or more from the stored value from the weekly cell blank measurement, this cell will not be used for analysis.
3
Dispensing of sample
Table 7-1
After rinsing and cell blank measurement are done, the water is aspirated and the cell is dried. The reaction cell returns to the sampling position and dispensing of sample starts.
Workflow of a measurement sequence
Roche Diagnostics
Operator’s Manual · 4.2.1
179
7 cobas c 502 module
Top view cobas® 8000 modular analyzer series
Description of a measurement sequence
4
Adding reagents Reagents R1, R2, and R3 are added at the determined positions and times (0, 2 and
5 minutes). Every time one of the reagents R1, R2, and R3 is added, the fluid in the cell is mixed at the corresponding mixing position by means of the ultrasonic mixer.
6 s - sampling time
8.6 s - measuring time
5
Calculating result Sampling is carried out every 6 seconds. Measurement is performed 70 times/cell in
10 minutes. After all measurements are completed, the concentration is calculated using the absorbance at the specified points of the reaction process.
6
Cleaning the reaction cell The instrument aspirates the reaction solution using the cell rinse units and performs the wash sequence with detergent followed by rinsing with water.
7
Automatic stop
Table 7-1
The instrument goes into Standby if the Rack Reception Mode is not activated.
Workflow of a measurement sequence
Roche Diagnostics
180 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Maintenance push button
7 cobas c 502 module
Top view
Figure 7-14 Maintenance push button
The maintenance push button is located beside the pipetter probe for the incubator bath detergent (Ecotergent). It is used to move a pipetter probe to predefined positions to check its horizontal alignment.
Roche Diagnostics
Operator’s Manual · 4.2.1
181
7 cobas c 502 module
Front view
Front view
cobas® 8000 modular analyzer series
This section presents all elements which are located behind the front doors.
A B
Roche Diagnostics
182
C D E F
A Syringes
B Cooling unit
D Drain port for condensation water in the vacuum system
E Vacuum system (hidden)
C Detergent bottles (CellCln 1 and CellCln 2) F Reagent pack disposal
Figure 7-15 Components behind the front doors
Syringes These syringes are in charge of transporting reagent and sample liquid.
Cooling unit The cooling unit is used to maintain a constant temperature of the incubator bath and to cool the reagent packs.
Detergent bottles These bottles are filled with detergents for the cell rinse process.
u
For more information about the cell detergents, see
Auxiliary reagents (cobas c 502 module) (p. 385).
Drain port The drain port is used to drain the tank compartment of the vacuum system.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Syringes
7 cobas c 502 module
Front view
The syringes are used to control the pipetting actions of the different probes. The probes are connected to the syringe by tubing.
The syringes are filled with degassed and deionized water, using positive displacement to aspirate and dispense solutions via the corresponding probes.
A B C D
A Sample syringe
B Reagent syringe R1
Figure 7-16 Location of syringes
C Reagent syringe R2/R3
D Syringe for incubator bath detergent
Sample syringe A sample syringe aspirates the determined volume of sample and discharges it into a reaction cell. A pressure sensor between the probe and the pipetter monitors the sample-aspirating state and detects clots.
Reagent syringes The R1 syringe aspirates the determined volume of reagent R1 and discharges it into a reaction cell.
The R2/R3 syringe aspirates the determined volume of reagent R2/R3 and discharges it into a reaction cell, also according to the test setup.
Syringe for incubator bath detergent
By using positive displacement, this syringe aspirates and dispenses Ecotergent into the incubator bath in order to prevent the formation of bubbles.
Roche Diagnostics
Operator’s Manual · 4.2.1
183
7 cobas c 502 module
Front view
Detergents and filter
cobas® 8000 modular analyzer series
Filter of cooling unit The radiator of the cooling unit is equipped with a dust filter that must be cleaned in course of regular maintenance.
Detergent bottles The two large bottles located behind the front door of the module contain detergents for cleaning purposes. Cell cleaner 1 is a basic detergent and Cell cleaner 2 is an acid detergent.
Vacuum system
The vacuum system is located behind the front of the module. It consists of a vacuum pump, vacuum tank, vacuum sensor, and connecting tubing.
The vacuum system aspirates reaction mixture waste from the reaction cells to the reaction waste container and removes reaction cell rinse water from the module through the main drain line.
The vacuum system must be checked routinely as part of the maintenance.
u
To locate the drain ports of the vacuum system, see figure 7-15, p. 182.
Roche Diagnostics
184 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Rear view
The module as seen from the rear side.
7 cobas c 502 module
Rear view
F
G
H
A Maintenance tap
B Outlet for diluted waste
C Outlet for highly concentrated waste
D Liquid level sensor assembly
Figure 7-17 c 502 rear view
A B C
D
E
E Water tank
F Water inlet
G Power circuit breaker
H Power inlet
Diluted waste Main drain outlet - connected to a drain pipe.
Highly concentrated waste Outlet for highly concentrated waste. This waste must be treated as infectious waste according to the local regulations.
q o Further handling of concentrated waste solution depends on the facilities of the laboratory. Some laboratories use containers; others may connect hoses leading to their drainage system. o When using waste containers, always make sure that the container is present and empty at the beginning of daily analysis.
Liquid level sensor assembly Water tank cap with a float for the integrated level control.
Water tank This tank buffers peak water consumptions during routine work.
Water inlet Main water supply.
Power inlet The mains supply of the module is connected here.
Power circuit breaker The power circuit breaker provides protection in case of an internal electrical short. It is also used to switch the module on or off, for example when performing manual maintenance.
Roche Diagnostics
Operator’s Manual · 4.2.1
185
7 cobas c 502 module
Rear view cobas® 8000 modular analyzer series
Roche Diagnostics
186 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
cobas e 602 module
8 cobas e 602 module
8
This chapter provides a detailed description of the e 602 module, its components and technical specifications. In addition, an overview of the reagents used on the e 602 module is provided.
In this chapter
Chapter
8
Roche Diagnostics
Operator’s Manual · 4.2.1
187
8 cobas e 602 module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
188 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview
8 cobas e 602 module
Overview
The e 602 module is a fully automated analyzer for immunoassay analysis. It is designed for both quantitative and qualitative in vitro determinations using a large variety of tests for analysis. Samples are transported to the e 602 module by the core unit of the cobas 8000 system.
A
A Module sample buffer
Figure 8-1 e 602 module
B
B e 602 module
Components of the e 602 module The e 602 module can be subdivided into the following areas: o
Reagent area u
See
o
Measuring area u
See
o
Pre-wash area u
See
o
Consumables area u
See
o
Components behind the front doors u
See
o
Components at the rear side u
See
Roche Diagnostics
Operator’s Manual · 4.2.1
189
8 cobas e 602 module
Top view
Top view
cobas® 8000 modular analyzer series
The figure presented below shows the top view of the module.
A
C
B
Pre-wash area
D
A Pre-wash area C Measuring area (incubator and measuring unit)
D Consumables area B Reagent area
Figure 8-2 e 602 module – top view
The top of the e 602 module includes the pre-wash, reagent, measuring, and consumables areas. The following sections describe these areas.
The Pre-wash station, located in the middle at the back of the analytical module, carries out a pre-wash step to remove special serum constituents from the reaction solution before measuring, if required by the assay protocol.
The Pre-wash area of the e 602 module consists of the following components: o
A Pre-wash gripper o
A Pre-wash dispenser o
A Pre-wash sipper o
A rinse station o
Two separation stations o
A vortex mixing station
Roche Diagnostics
190 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
A B C D
8 cobas e 602 module
Top view
A Dispenser
B Sipper
C Rinse station
Figure 8-3
E
D Separation stations
E Vortex mixing station
F Gripper
Components of the Pre-wash area
F
Pre-wash dispenser The dispenser is located at the back and on the left of the Pre-wash area, next to the sipper. It dispenses PreClean solution (a phosphate buffer) into the AssayCup after the sipper has drained the reaction solution.
Pre-wash sipper The sipper is located at the back and on the left of the Pre-wash area, next to the dispenser. It aspirates the reaction solution from the AssayCup positioned in one of the separation stations.
Rinse station The rinse station for sipper and dispenser probes is located next to the sipper and dispenser. It rinses the corresponding probe after each aspiration or dispensing procedure with deionized water.
Separation stations Two separation stations (AssayCup holders) are located in front of the sipper and dispenser, which are in the middle of the Pre-wash area. The separation stations are permanent magnets used to capture the microbeads in the AssayCup as the reaction solution is being aspirated by the sipper.
Vortex mixing station The vortex mixing station is located between the gripper and the separation stations.
After the wash procedure, the AssayCup is placed here by the gripper to resuspend microbeads in the PreClean solution.
Pre-wash gripper The Pre-wash gripper is located left behind of the incubator and can move between the incubator and the Pre-wash area.
It is equipped with gripping fingers for gripping AssayCups that are filled with the reaction solution in the incubator and for transporting them to the separation stations in the Pre-wash area and back. The gripper also transports the AssayCups from the separation stations to the vortex mixer.
Roche Diagnostics
Operator’s Manual · 4.2.1
191
8 cobas e 602 module
Top view
Reagent area
cobas® 8000 modular analyzer series
The reagent area is on the left side of the analytical module and is in charge of transporting reagents to individual positions in the incubator.
The reagent area of this module consists of the following components: o
A temperature controlled reagent compartment for storing up to 25 reagent packs o
A microbead mixer with rinse station o
A reagent probe with rinse station o
A Pre-wash station
B C D E F
G
H
A
A Barcode reader
B Reagent cap open/close mechanism
C Reagent disk
D Microbead mixer rinse station
Figure 8-4 Reagent area components
E Microbead mixer
F Reagent probe
G Reagent probe rinse station
H ProbeWash station
Reagent disk The reagent disk is located on the left side of the analytical module and contains
25 positions for assay, diluent or pretreatment cobas e packs. The reagent disk is temperature controlled at 20 ± 3 °C (62.6 to 73.4 °F).
q Diluent or pretreatment reagent packs can be placed in any position on the reagent disk.
More than one cobas e pack can be loaded on the reagent disk for each test at any time.
Barcode reader The barcode reader is located in the center of the reagent disk and reads the
2D matrix barcode on the cobas e packs.
Reagent cap open/close mechanism
To prevent reagents from evaporating, and for ease of use, the reagent disk is equipped with a reagent cap open/close mechanism. The mechanism is located on the back wall of the reagent disk compartment and emerges when cobas e packs need to be opened or closed. The reagent caps are opened only for pipetting and mixing and are closed again afterwards. This is the default setting for all tests, which should not be changed to keep evaporation as low as possible.
Roche Diagnostics
192 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 8 cobas e 602 module
Top view q Soft-close position of caps
Before loading a reagent pack, open the caps manually and set them gently to the softclose position : The caps are almost closed, but not tightly closed. This ensures the caps can be easily opened by the mechanism.
u
See Reagent packs – cobas e packs (p. 394).
Microbead mixer with rinse station
The microbead mixer is located beside the reagent disk. It mixes the microbeads in one compartment of each cobas e pack to ensure a homogeneous suspension before aspiration.
The microbead mixer rinse station rinses the microbead mixer with deionized water each time it has been used.
Reagent probe with rinse station The reagent pipetter, located between reagent disk and incubator, aspirates reagent from the cobas e packs on the reagent disk and dispenses it into the AssayCups in the incubator. To prevent reagent carryover, the reagent probe is rinsed after each pipetting operation at the rinse station. The reagent probe also has liquid level sensing for accurate pipetting.
The reagent probe rinse station rinses the inside and outside of the reagent probe externally and internally with deionized water between aspirations.
ProbeWash station The ProbeWash station, located on the analytical module near the reagent probe, consists of two bottles of ProbeWash. ProbeWash is used to wash the inside of the reagent probe to prevent carryover.
Measuring area
The measuring area is in the middle of the analytical module and consists of the following components: o
A sample probe with rinse station o
A incubator disk o
Two sipper probes with rinse stations o
A Pre-wash station
Roche Diagnostics
Operator’s Manual · 4.2.1
193
8 cobas e 602 module
Top view cobas® 8000 modular analyzer series
A
B
C
D
A Sample probe
B Incubator disk
Figure 8-5 Measuring area components
C Sipper probes
D Sipper probe rinse stations
Sample probe The sample probe is located between the rack processing line and the incubator. The sample probe transports sample, calibrator or control fluids from the sample tubes in the racks into the AssayCups in the incubator. The probe uses a new disposable tip for every pipetting sequence to prevent carryover. It has liquid level and clot detection for accurate pipetting. Liquid level detection is accomplished by capacitance measurement. Clot detection is accomplished by a pressure transducer.
CAUTION
Incorrect results due to residues on the sample probe
Residues on the sample probe seriously affect the probe performance.
r Do not touch the surface of the sample probe with bare hands as this leaves residues on the probe.
r If you do touch the probe, wipe it immediately with a gauze pad moistened with alcohol, then with a gauze pad moistened with deionized water.
Incubator disk The incubator disk contains 54 positions for AssayCups and is located approximately in the center of the analyzer unit. It is maintained at a temperature of 37.0 ± 0.3 °C to ensure/facilitate reaction between the sample and the reagents that have been dispensed into an AssayCup.
When an assay is ready for measurement, the incubator rotates, moving the
AssayCup to the various positions in the assay protocol process. It transports each
AssayCup to the position where the appropriate unit performs its respective task.
Roche Diagnostics
194 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 8 cobas e 602 module
Top view
Sipper probes with rinse stations There are two sipper probes located in front of the incubator (one probe for measuring channel 1 and the other probe for measuring channel 2). These aspirate the reaction mixture from the AssayCup in the incubator into the measuring channels as well as the ProCell and CleanCell from their respective cups in front of the sippers.
One rinse station for each sipper probe is located next to the sipper probes. Between measurements, the sipper probes move to their rinse stations where the outside is washed with deionized water. In Standby, the sipper probes are located directly above their rinse stations.
Measuring cell
A B C
Roche Diagnostics
Operator’s Manual · 4.2.1
D E F G H
A Cell body
B Top cell
C Counter electrode
D Inlet
Figure 8-6 Measuring cell
E Movable magnet
F Working electrode
G Outlet
H Reference electrode
The two measuring cells, which are located inside the analytical module, are the central components of the measuring channels of the e 602 module for the determination of samples.
ECL technology Electrochemiluminescence (ECL) is a process in which highly reactive species are generated from stable precursors at the surface of an electrode.
When an electrical field is applied, the electrochemically active precursors react with one another, yielding an unstable excited state compound, which finally decays under the emission of light. From the measured intensity of that light, the system can calculate the analyte concentration in the sample.
u
For more details refer to the chapter e 602 module – ECL technology on the COBI CD.
195
8 cobas e 602 module
Top view cobas® 8000 modular analyzer series
Immunoassay analysis workflow
Three test principles are available on the e 602 module: Competitive principle (for extremely small analytes), sandwich principle (for larger analytes), and a bridging principle (to detect antibodies in the sample). The following workflow of an assay sequence represents the sandwich principle.
6WDUW
3UHSDUDWLRQ
$GGLQJ55
$GGLQJVDPSOHPL[LQJ
$GGLQJPLFUREHDGVPL[LQJ
3UHSDULQJPHDVXULQJFHOO
$VSLUDWLQJUHDFWLRQPL[WXUH
&DOFXODWLQJWKHUHVXOW
&OHDQLQJPHDVXULQJFHOO
$XWRPDWLFVWRS
(QG
Figure 8-7 Workflow of a measurement sequence
Description of a measurement sequence
1
Preparation After start, the instrument mechanic moves to its default position.
Every 21 seconds a sample sequence is performed.
The xyz arm (gripper) transports an AssayTip into the AssayTip station and an AssayCup into the incubator.
2
Adding reagents The reagent probe aspirates R1, is rinsed at the rinse station and aspirates R2. Then R1/R2 are dispensed into the AssayCup.
3
Adding sample
Table 8-1
The sample probe takes the AssayTip and aspirates sample. The sample is dispensed into the AssayCup.
The sample probe aspirates mixture of R1/R2 and sample and dispenses the mixture again into the AssayCup (tip mixing).
The AssayCup with reaction mixture is incubated at 37°C for 9 minutes.
Workflow of a measurement sequence.
Roche Diagnostics
196 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 8 cobas e 602 module
Top view
Description of a measurement sequence
4
Adding microbeads Before the first incubation is completed, the microbeads are mixed (3.7 seconds).
The reagent probe aspirates the microbeads and dispenses them into the AssayCup.
The gripper pick up and transports the AssayCup with the reaction mixture into the vortex mixing station and afterwards back into the incubator.
The AssayCup is incubated again at 37°C for 9 minutes.
5
6
Preparing measuring cell
Aspirating reaction mixture
Before the second incubation is completed, the sipper probe aspirates ProCell into the measuring cell to facilitate measurement.
The sipper probe aspirates 130 mL of the reaction mixture. The gripper pick up and transports the AssayCup to the cup disposal opening and discards the cup.
7
Calculating result The sipper probe aspirates ProCell into the measuring cell. The immune complex is captured by a magnet onto the electrode of the measuring cell. The ProCell washes away all unbound reagent and serum constituents.
The ECL reaction is initiated and measured by the photomultiplier. The photomultiplier converts the ECL signal into an electrical signal from which the e 602 calculates the assay result.
8
9
Cleaning measuring cell
Automatic stop
Table 8-1
After measurement, the measuring cell is rinsed with CleanCell and ProCell.
The instrument goes into Standby if the Rack Reception Mode is not activated.
Workflow of a measurement sequence.
Roche Diagnostics
Operator’s Manual · 4.2.1
197
8 cobas e 602 module
Top view
Consumables area
cobas® 8000 modular analyzer series
The components of the consumables area are located on the right of the analytical module.
The consumables area of the e 602 module consists of the following components: o
A gripper o
A AssayTip buffer station o
Disposal openings for AssayTips and AssayCups o
A vortex mixing station
C
D
A
B
A Gripper
B Green status lamp
Figure 8-8
C
D
AssayTip buffer station with disposal opening
Vortex mixing station
Consumables area components
Some components of the consumables system are behind the right front door of the module.
u
For more information about these components, see
Consumables components (p. 203).
Roche Diagnostics
198 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 8 cobas e 602 module
Top view
Gripper The gripper is located on the right of the analytical module and can move in 3 directions: o
X (left and right) o
Y (forward and back) o
Z (up and down)
It is equipped with gripping fingers for gripping tips or AssayCups. The gripping fingers pick up an AssayCup from the magazine and transport it to the incubator or from the incubator to the vortex mixing station. After the AssayCup has been used, the gripper transports it to the cup disposal opening. The gripper also transports tips from the tip tray to the tip buffer where the sample probe picks them up for the next sampling.
During operation, the gripper is supplied with tips and AssayCups from the magazine lifter, which transport the magazines to the top of the analytical module. Empty magazines are discarded automatically to the magazine waste inside the analytical module.
Vortex mixing station The vortex mixing station, located between the gripper and the tip buffer, mixes the reaction solution after reagent delivery. AssayCups are transported here from the incubator by the gripper.
AssayTip buffer station with disposal openings
The AssayTip buffer station with disposal openings is located between the vortex mixing station and the sample probe. The gripper transports new tips here as required by the sample probe. The sample probe takes the new tip and, after pipetting samples, discards the used tip at the disposal opening into the active solid waste container.
AssayCup disposal openings Used AssayCups are discarded by the gripper in the AssayCup disposal openings, located between the incubator and the vortex mixing station. The used cups pass into the active solid waste container.
Green status lamp The status lamp is located on the top of the right front door and indicates when the magazine drawer and door can be opened.
Lamp On
Lamp flashing
Lamp Off
Drawer safe to open
About to operate—DO NOT open
Operating—DO NOT open
Roche Diagnostics
Operator’s Manual · 4.2.1
199
8 cobas e 602 module
Front view
Front view
cobas® 8000 modular analyzer series
This section presents all elements located behind the front doors.
A
B
A Syringes
B Auxiliary reagents and cleaning solutions
Figure 8-9
C Consumables
Components behind the front doors
C
Syringes These syringes are in charge of transporting reagent and sample liquid.
Auxiliary reagents and cleaning solutions
These bottles are filled with solutions for the measurement and cleaning process.
Consumables It is a storage for new and used consumables (for example AssayCups and
AssayTips).
Roche Diagnostics
200 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Syringes
8 cobas e 602 module
Front view
The syringes are used to control the pipetting actions of the different probes. The probes are connected to the syringe by tubing.
The syringes are filled with degassed and deionized water, using positive displacement to aspirate and dispense solutions via the corresponding probes.
A
B
C
A Reagent syringe B Sample syringe
C Sipper syringes
Figure 8-10 Syringes
Reagent syringe The reagent syringe is located on the left behind the front door of the analytical module. The reagent syringe aspirates the determined volume of reagent and discharges it into a AssayCup.
Sample syringe The sample syringe is located on the right behind the front door of the analytical module. A sample syringe aspirates the determined volume of sample and discharges it into a AssayCup.
Sipper syringes The sipper syringes are located on the right behind the front door of the analytical module.
Roche Diagnostics
Operator’s Manual · 4.2.1
201
8 cobas e 602 module
Front view cobas® 8000 modular analyzer series
Auxiliary reagents and cleaning solutions
The auxiliary reagent bottles of ProCell and CleanCell (two each) are located behind the front door of the e 602 module, and two bottles of PreClean are mounted on the inside of the door itself.
A
C
B
A PreClean bottles
B ProCell bottles (in keyed positions)
Figure 8-11
C CleanCell bottles (in keyed positions)
Auxiliary reagents on the e 602 module
PreClean bottles Two bottles of PreClean are located on the inside of the front door of the module.
Each bottle has a volume of 600 mL. Two bottles of PreClean allow bottle changeover without interrupting operation. The system monitors the amount of PreClean available by counting the number of pipetting actions. In addition, liquid short sensors (LSS) are available in case of inaccurate counting due to incorrect loading of
PreClean bottles.
u
See Replacing auxiliary reagents (cobas e 602 module) (p. 404).
CAUTION
Personal injury due to contact with PreClean needles r Do not put your hand into the PreClean bottle holders as the needles are sharp and could cause injury.
r
Observe in particular the following safety label on the instrument: F-16 (p. 43).
ProCell and CleanCell bottles Two bottles of ProCell and two bottles of CleanCell are located in special, keyed positions behind the front door: o
ProCell is a buffer solution containing tripropylamine (TPA). These bottles are identified with white caps. o
CleanCell is a solution of potassium hydroxide (KOH) which is used to clean the measuring channel after measurement. CleanCell bottles are identified with black caps.
The ProCell and CleanCell bottle positions are keyed to ensure the correct reagent is placed in the proper position. Each bottle has a volume of 2 liters, which is sufficient for 1000 determinations prior to initial priming. Two bottles of each reagent allow bottle changeover without interrupting operation.
Roche Diagnostics
202 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 8 cobas e 602 module
Front view u
See Replacing auxiliary reagents (cobas e 602 module) (p. 404).
q If a ProCell bottle is replaced, the lot number of the new bottle must be entered into the system.
Consumables components
A Magazine lifter
A B C
B Solid waste container
C Magazine waste compartment
Figure 8-12 Magazine drawer
Magazine lifter The magazine lifter is located behind the right front door of the analytical module and is the first compartment of the magazine drawer. The magazine lifter transports the full magazines with AssayCups and AssayTips to the top of the analytical module as required. The lifter can be loaded with magazines by opening the transparent door of the magazine drawer. The magazines can be loaded on the magazine lifter only when the green status lamp is permanently on.
Solid waste containers The solid waste containers for used AssayCups and AssayTips are located behind the right front of the analytical module and they are the third compartment of a magazine drawer. The 2 containers are used alternately. When one becomes full, the other becomes active. The full waste container can be emptied only when the green status lamp on the magazine drawer is permanently illuminated (i.e., the magazine drawer can be pulled out). The green illuminated push button corresponding to the container must be pressed after the container has been emptied.
Magazine waste compartment The magazine waste compartment contains the empty magazines. It is located behind the right front of the analytical module and the middle part of a magazine drawer and it is the second compartment. The magazine waste can be emptied by pulling out the magazine drawer. The magazine drawer can be pulled out only when the green status lamp is permanently illuminated.
Roche Diagnostics
Operator’s Manual · 4.2.1
203
8 cobas e 602 module
Rear view
Rear view
The module as seen from the rear side.
cobas® 8000 modular analyzer series
G
F
A Outlet for diluted waste
B Outlet for highly concentrated waste
C Liquid level sensor assembly
D Water tank
Figure 8-13 e 602 rear view
A B C D E
E Water inlet
F Power inlet
G Power circuit breaker
Diluted waste Main drain outlet - connected to a drain pipe.
Highly concentrated waste Outlet for highly concentrated waste. This waste must be treated as infectious waste according to the local regulations.
q o Further handling of concentrated waste solution depends on the facilities of the laboratory. Some laboratories use containers; others may connect hoses leading to their drainage system. o When using waste containers, always make sure that the container is present and empty at the beginning of daily analysis.
Liquid level sensor assembly Water tank cap with a float for the integrated level control.
Water tank This tank buffers peak water consumptions during routine work.
Water inlet Main water supply.
Power inlet The mains supply of the module is connected here.
Power circuit breaker The power circuit breaker provides protection in case of an internal electrical short. It is also used to switch the module on or off, for example when performing manual maintenance.
Roche Diagnostics
204 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Specifications
9 Specifications
9
Roche Diagnostics
Operator’s Manual · 4.2.1
This chapter gives an overview of the specifications of the cobas 8000 instrument and its components.
In this chapter
Chapter
9
Environmental conditions during transport and storage ...................................... 209
205
9 Specifications
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
206 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
System specifications
System specifications
The following specifications apply to the cobas 8000 modular analyzer series.
Dimensions
Y
Module
Core unit
(incl. STAT port)
Layout X
1020
40.2
Y
1140
44.9
Z
930
36.6
mm inch
Weight
200 kg
440 lb
Z
X cobas ISE
(1 ISE unit) cobas ISE
(2 ISE units) cobas c 701
(incl. MSB)
450
17.7
450
17.7
1500
59.1
1140
44.9
1140
44.9
1140
44.9
1150
45.3
1150
45.3
1350
53.1
mm inch mm inch mm inch
170 kg
380 lb
180 kg
400 lb
700 kg
1540 lb cobas c 702
(incl. MSB)
1500
59.1
1140
44.9
1350
53.1
mm inch
760 kg
1680 lb cobas c
(incl. MSB) cobas e
502
602
(incl. MSB)
1500
59.1
1140
44.9
1300
51.2
mm inch
540 kg
1190 lb
1500
59.1
1060
41.7
1140
44.9
mm inch
590 kg
1300 lb
Table 9-1
X
Y
Z
Dimensions and weights of the cobas 8000 modules
Width
Depth
Height
Roche Diagnostics
Operator’s Manual · 4.2.1
207
9 Specifications
System specifications
Operating conditions
cobas® 8000 modular analyzer series
The power distribution panel and the water supply and drainage facilities must be available within 5 meters (200 inches) of the system.
Water requirements Use distilled or deionized water (with a maximum conductivity of 1 μ S/cm) for routine operation and maintenance. In addition, do not forget to perform maintenance and check on the deionizer (deionized water supply unit). For details, contact the manufacturer or dealer.
Bacteria-free, deionized water
Conductivity
Water pressure
Water temperature
Water consumption
< 10 cfu/mL
1.0 μ S/cm or less
50–340 kPa (0.5–3.4 kg/cm²)
> 12 °C o o must provide ≥ 100 L/h c 701 / c 702 module: approx. 36 L/h (including ISE module) o c 502 module: approx. 40 L/h o e 602 module: approx. 30 L/h (< 40 L/h)
Electric power supply
Line voltage
Power supply fluctuation
Overvoltage category
Pollution degree (IEC 61010-1)
Power consumption
Single phase AC 200/208/220/230V 50/60 Hz
No significant power supply fluctuation (max. power supply change: ± 10%)
II
2
Core: 1 kVA
ISE: 0.5 kVA c 701 / c 702 (incl. MSB): 3 kVA c 502 (incl. MSB): 2.5 kVA e 602 (incl. MSB): 3 kVA
WARNING
CAUTION
Electrical shock by electronic equipment r The power supply must be grounded. r The instrument must only be connected to a power supply source with the specified power supply cable and only by authorized personnel.
Incorrect results due to improper grounding of the electrical installations within a building
If grounding is poor, external noise will have a greater influence on the instrument.
r Comply with the specifications for electrical installation.
Roche Diagnostics
208 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
System specifications
Environmental conditions
The following environmental conditions should be followed in order to ensure correct operation of this system:
Ambient temperature during operation
Ambient humidity
Waste volume
Installation altitude
Noise emission
Other environmental conditions
Floor condition
18–32 °C (64.4–89.6 °F) with changes < ±2 °C/h (±3.6 °F/h) o o o
30–85% (non-condensing) c 701 / c 702 module: approx. 2.4 L/h concentrated waste solution including wastes of ISE tests c 502 module: max. 2.5 L/h concentrated waste solution and max. 37.5 L/h diluted waste solution e 602 module: approx. 1.0 L/h concentrated waste solution (approx. 6 mL waste per determination) up to 2000 m above sea level
< 85 dB(A) to surrounding o
Dust-free environment with air-condition o
No direct sunlight o
No perceptible vibration o
Indoor use only
Level flatness below 0.5% related to horizontal; strong enough to hold the weight of the instrument, see
Environmental conditions during transport and storage
Ambient temperature during transport and storage
Ambient humidity
Vibration
Max. drop height
Max. shock
-20 to 75 °C (-4 to 167 °F)
5–95%
≤ 15.8 m/s²
0.3 m (11.8 in)
≤ 98 m/s²
Roche Diagnostics
Operator’s Manual · 4.2.1
209
9 Specifications
Control unit
Control unit
cobas® 8000 modular analyzer series
Computer
Monitor
Input devices
Computer stand
Computer with Windows operating system
17" TFT color monitor
Mouse, touchscreen, keyboard
Optional, ergonomic (UL, CE, GS, TüV)
Data storage capacity
Sample data (routine/STAT/QC)
Reaction process data
Calibration data
12 000 samples (including reruns)
12 000 samples
15 000 reagent packs for clinical chemistry
2 000 reagent packs for immune chemistry
System interface
The cobas 8000 modular analyzer series can be interfaced with an LIS by an Ethernet network.
The network connection will be established between the data manager and an LIS.
q All data processing equipment connected to the system must comply with the relevant standards of IEC, UL and CSA.
Roche Diagnostics
210 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Core unit
9 Specifications
Core unit
In addition to specifications of the core unit itself, this section provides an overview of specifications of the system interface, barcodes, and sample containers.
u
For more information, see:
Container specifications (p. 213)
The following specifications apply to the rack sampler unit of the core unit.
System start-up time
(power on to standby)
Power-off time
Rack transfer (throughput)
Rack loading area
Rack unloading area
Rerun buffer
Sample racks
Rack identification
STAT samples approx. 9 to 10 min (depending on module configuration) approx. 2 min o without tube rotation: up to 200 racks/h (1000 samples/h) o with tube rotation: up to 160 racks/h (800 samples/h) (< 180° turn) up to 120 racks/h (600 samples/h) (> 180° turn)
(1)
Input: 2 trays with 15 racks each (150 samples)
Buffer: 2 trays with 15 racks each (150 samples)
Output: 2 trays with 15 racks each (150 samples)
Buffer: 2 trays with 15 racks each (150 samples)
Located in the module sample buffer located at each instrument module.
Up to 20 racks (100 samples) for automatic rerun possible.
o
Roche standard rack (without tube rotation) o
MPA rack (with tube rotation)
Identified by barcodes
Placed on a red STAT rack and placed into the STAT port
(1) The throughput of the rack loading may vary depending on the rotation degree of the sample tubes in order that the barcodes are successfully read.
Roche Diagnostics
Operator’s Manual · 4.2.1
211
9 Specifications
Core unit
Barcode types
cobas® 8000 modular analyzer series
CAUTION
Barcodes used with the cobas 8000 instrument must be in compliance with one of the following standards: o
NW7 (Codabar) o
Code 39 o
ITF o
Code 128
Incorrect results due to undetected reading errors
Barcode reading errors could potentially go undetected when a check digit is not used.
r Use only barcodes with check digits. r Use only barcode labels of a good printout quality.
r When using ITF, do not use mixed-up ID digit numbers.
Sample barcodes The following specifications apply to the various barcode types:
Reading method
Used barcode symbol
Check digit
Number of ID digits
Characters usable for ID
Check digit
Scanning with CCD sensor
NW7 (Codabar), Code 39, ITF, Code 128
Must be used to prevent scanning errors.
NW7 3–22 digits + 1 digit (with check digit)
Code 39
ITF
3–22 digits + 1 digit (with check digit)
3–22 digits + 1 digit (with check digit)
Code 128 4–12 digits + 2 digits (with check digit)
NW7
0 to 9, -, /, ., $, :, +
(1)
Code 39 0 to 9, A to Z, -, ., [ ], /, +, $, %
ITF 0 to 9
Code 128 Alpha numerics (excluding those assigned to functions and communications)
NW7 Modulus 16, Modulus 11, Modulus 10/2 weight, Modulus 10/3 weight, 7 check DR, weighted Modulus 11, Modulus 10/2 weight A
Code 39
ITF
Modulus 43
Modulus 10/3 weight
(1) For more information about usable characters and check digit characterization, refer to the common specifications for the different barcode types.
Sample rack barcodes The following barcode types are used for sample racks:
Barcode, number of digits ITF 5 digits + check digit
Roche Diagnostics
212 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
Core unit
Container specifications
This table shows the applicable container types and their specifications.
Container
Standard sample tube
(can be used for cup on tube
Standard sample tube
)
Diameter × length

16 × 100 mm

16 × 75 mm

13 × 100 mm

13 × 75 mm
Dead volume
1000
1000
500 μ
μ
μ
L
L
L
Hitachi standard cup 2.5 mL or cobas sample cup 2.5 mL
Hitachi micro cup 1.5 mL
(1)
Non-standard tube
(3)
500 μ L
100
50 μ
μ
L
L
(2)
False bottom tube (FBT)
(5)
RD false bottom tube
(5)

11–16 × 63–102 mm
(4)
(for e 602:

13–16 mm)


13–16 × 63–102 mm
13 × 75 mm
(4)
200 μ L
(6)
100 μ L
(7)
Table 9-2 Specifications of container types
(1) Not applicable for calibrators and controls. Not to be used on e 602 modules!
(2) Select Micro on the Test Selection submenu under Sample Cup . Only in this case is the dead volume valid.
(3) Not applicable for calibrators and controls.
(4) Inner diameter > 10 mm (> 9.7 mm for HbA1c whole blood samples).
(5) Not applicable for calibrators. See notes in section
False bottom tubes (FBT) (p. 214).
(6) If the tubes are used without cup adapter for immunoassays.
(7) If the tubes are used for photometric tests or cup adapters are used for immunoassays.
u
For containers used for the HbA1c application, see
Sample tubes for the HbA1c application (p. 547).
Roche Diagnostics
Operator’s Manual · 4.2.1
213
9 Specifications
Core unit cobas® 8000 modular analyzer series
Standard cups and micro cups
CAUTION
Standard cups and micro cups are too small to hold a barcode label, but it is possible to place them onto 16 mm sample tubes with a barcode label. Both cups can also be placed directly in a rack.
Only the following original standard cups are certified by Roche: o
Hitachi standard cup 2.5 mL o cobas sample cup 2.5 mL (catalog no. 10394246001)
Although non-Roche sample cups look the same, their inner geometry may be different and they may have been produced using non-specified materials. The liquid level detection and the level tracking are influenced by the inner geometry of the cup.
Thus, air may be pipetted when non-Roche cups are used. This might go unnoticed under certain circumstances.
Incorrect results when using non-certified cups
Sample cups from other vendors may cause inaccurate sample pipetting which may lead to incorrect results. r Use only cups certified by Roche.
CAUTION
CAUTION
Incorrect results or damage to the instrument due to wrong application of cups
Standard cups and micro cups must be used as registered. If used incorrectly, sample pipetting will not be accurate, leading to incorrect results. The sample probe may also be damaged.
r Use the cup size as registered for each sample.
r Do not use micro cups for calibrators and controls.
Incorrect results due to the use of micro cups on e 602 modules
When the tip of the sample probe touches the inner wall of a micro cup, this may result in improper sample aspiration.
r Do not use micro cups on e 602 modules.
False bottom tubes (FBT)
There are some module-specific differences regarding the use of false bottom tubes: o
For c 502 and e 602 modules:
O
Only one FBT type can be used, which is defined on Utility > System > Rack
Assignment > False Bottom 1 .
O
As for c 701/ c 702 modules, the FBT type can be used for patient samples, or if configured by Roche, for auto QCs or for manual QCs.
o
For c 701/ c 702 modules: Three different FBT types can be defined for patient samples (see exception below).
O
Alternatively, the whole instrument can be configured to use one FBT type either for auto QCs or for manual QCs ( False Bottom 1 tab).
O
In this case, only False Bottom 2 and 3 can be used for patient samples.
O
The usage of FBT for controls can be configured by Roche service representatives or technical support only.
Roche Diagnostics
214 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
Core unit q Exception
If a c 502 or e 602 module is part of the system, the FBT types 2 and 3 are not supported for c 701/ c 702 modules. In this case, only the False Bottom 1 tab can be used for all modules.
Maximum fill height
To prevent any splashing during processing of sample containers, the maximum fill height should not exceed 10 mm below the top edge of each container:
-10 mm
WARNING
Figure 9-1 Maximum fill height for containers
Infection and damage by spilled sample during operation
The sample containers may vibrate during rack transport and rotation of sample tubes.
Sample may be spilled on the transport mechanisms.
r Avoid overfilling sample tubes and cups.
r Leave approximately 10 mm clearance between the liquid and the top of the tube or cup.
r If sample is spilled on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
Which container for which application?
This section shows how the different sample containers can be used on the instrument.
The container type is automatically detected by the height of the container. All standard tubes (ST) including Hitachi micro cups and RD vials can be detected by sensors.
Non-standard tubes (NST) and false bottom tubes (FBT) cannot be detected. They are determined by the Rack Assignment settings: o
All tubes on a rack within the rack number range assigned to NST will be determined as NST.
o
All tubes on a rack within the rack number range assigned to FBT will be determined as FBT.
Rack assignment When using cups or tubes other than standard cups and tubes for normal samples, the rack range must be set for each container type on Utility > Application > Rack
Assignment .
For calibrators and controls, a rack assignment function is not available.
Roche Diagnostics
Operator’s Manual · 4.2.1
215
9 Specifications
Core unit cobas® 8000 modular analyzer series
Definitions
ST
NST
FBT
– l
These are standard containers: o o o
Standard sample tubes

13 or 16 mm, height 75 or 100 mm
Hitachi standard cups (or the equivalent cobas sample cups) o
Hitachi micro cups
Hitachi standard cups or micro cups on primary tubes with a height of 75 or
100 mm
Non-standard tubes (63–102 mm)
False bottom tubes (63–102 mm)
This container type must not be used.
This container type can be used.
Containers for ISE and photometric modules
ST
Container type
Standard containers
Hitachi micro cups
Sample l l
Calibrator l
–
NST
FBT
Table 9-3
RD calibrator / control vials
Non-standard tubes
False bottom tubes
– l l
–
–
–
Applicable containers for ISE and photometric modules
–
–
–
Control l
–
Containers for e 602 modules
Container type Sample Calib.
ST
Standard containers
Hitachi micro cups l
–
NST
FBT
Table 9-4
RD calibrator / control vials
Non-standard tubes
False bottom tubes
– l l
Applicable containers for e 602 modules
–
– l
–
–
(1) Controls prepared for pool serum, competitor’s product, or users choice.
–
–
–
– l
RD
Controls
Non-
Roche
(1) l
–
–
–
– u
If you would like to use other e 602 control containers, please contact your Roche service representative.
Application notes
ST
Container type
Standard containers
Hitachi micro cups are not to be used on e 602!
RD vials for e 602 calibrators or controls
Notes o o o o
Rack must be assigned as
Standard .
o
All types of standard cups and standard tubes can be mixed within a rack.
All sample types and containers can be mixed on rack range None of the
Standard tab.
Vials are detected as RD vials.
Only RD vials can be used within a rack.
Table 9-5 Application notes
Roche Diagnostics
216 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
Core unit
NST
Container type
Non-standard tubes
(63–102 mm)
FBT
Table 9-5
False bottom tubes
(63–102 mm)
The tube dimensions must be registered as
FBT1.
u
See
Application notes o
Notes o o
Rack must be assigned as
Non-Standard .
o
All containers are determined as NST, regardless of height.
Different NST containers can be mixed within a rack.
Rack must be assigned as
False Bottom 1 .
o
All containers are determined as FBT1, regardless of height.
o
Only one container type can be used within a rack!
u
For mixing different sample types on a rack, see also:
Mixing sample types and container types on a rack (p. 510)
u
Please contact Roche technical support for more information about the use of non-standard tubes and other sample containers.
Roche Diagnostics
Operator’s Manual · 4.2.1
217
9 Specifications cobas ISE module
cobas ISE module
cobas® 8000 modular analyzer series
Applications
Detection system
Throughput
Detection of sample clogging
Liquid level sensor
Mixing method
Measuring temperature
Cycle time
Na
+
, K
+
, Cl
-
in serum or urine
Ion-selective electrode system
One unit installed: Up to 900 tests/h (300 samples/h)
Two units installed: Up to 1800 tests/h (600 samples/h)
Pressure sensitive clot detection system
Capacitance sensing technology
Non-contact ultrasonic mixing
35 °C ± 2 °C
2 × 12 s
Measuring ranges
Measuring range (ser/pl)
Measuring range (urine)
Na
+
K
+
Cl
-
Na
+
K
Cl
+
-
80–180 mmol/L
1.5–10.0 mmol/L
60–140 mmol/L
20–350 mmol/L
(1)
3–100 mmol/L
20–350 mmol/L
(1)
(1) From 20–60 mmol/L, only increased sample volume (15 μ L) is effective.
Pipetting volumes
Sample pipetting volume for all sample types except urine
Sample pipetting volume for urine samples
15 μ L for first run (as Normal volume)
15 μ L for rerun (as Normal volume)
15 μ L for calibrators and controls
10 μ L for first run (as Normal volume) for Na
+
, K
+
, Cl
-
15 μ L for rerun (as Increased volume)
(1)
for Na
+
, Cl
-
10 μ L for rerun (as Normal volume)
(2)
for K
+
15 μ L for calibrators
Reagent pipetting volume
10 μ L for controls
Dil 450 μ L/sample (1/31 dilution for all sample types except urine; 1/46 dilution for urine samples)
ISE IS 500 μ L/sample (measurements in succession)
1050 μ L/sample (single measurement)
KCl 130 μ L/sample
(1) If the first run result for Na
+ or Cl
-
is between 10–60 mmol/L, the < >ISE flag is attached to the result.
The rerun test selection is generated and an automatic rerun is executed with increased sample volume.
(2) If the first run result for K
+
is < 3 or > 100 mmol/L, the < >Test flag is attached to the result. The rerun test selection is generated with normal sample volume. An automatic rerun is NOT executed.
Roche Diagnostics
218 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Photometric modules
The following specifications apply to the photometric modules.
u
For more information, see:
Photometric measuring system (p. 221)
9 Specifications
Photometric modules
Reaction system
c 701 c 702 c 502
Number of Applications o
Photometric o
Calculated tests o
Serum indices
Throughput (max.)
Reaction volume
Reaction temperature
(incubator bath)
Reaction cells
(semi-disposable cuvettes)
Reaction times
Pipetting cycle
Mixing method
Table 9-6
200 200
8
3
8
3
2000 tests/h
100–250 μ L
37 ±0.1°C
2000 tests/h
100–250 μ
37 ±0.1°C
L
200
8
3
600 tests/h
100–250 μ L
37 ±0.1°C
406 cells
(14 segments)
3–10 min, in 1-minute steps
1.8 s
Non-contact ultrasonic mixing
406 cells
(14 segments)
3–10 min, in 1-minute steps
1.8 s
Non-contact ultrasonic mixing
160 cells
(8 segments)
3–10 min, in 1-minute steps
6 s
Non-contact ultrasonic mixing
Reaction system q Processing capacity varies depending on measuring conditions, test selection and system configuration.
Roche Diagnostics
Operator’s Manual · 4.2.1
219
9 Specifications
Photometric modules
Reagent system
Sample types
Sample pipetting volume
Detection of sample clogging
Liquid level sensor
Table 9-8 Sampling system cobas® 8000 modular analyzer series
Reagent pack types
Reagent loading/unloading
Reagent identification c 701 o o cobas c pack large cobas c pack MULTI large
Manual
Automatic (RFID) c 702 o o cobas c pack large cobas c pack MULTI large
Automatic (performed by reagent manager)
Automatic (RFID) in reagent manager c 502 o o cobas c pack cobas c pack MULTI
Automatic
Automatic (barcode) o
Reagent storage
Max. number of reagent packs o
Reagent cooling
(in reagent disks)
Capacity of reagent buffer rotor
Capacity of reagent unloading tray
Reagent pipetting timings
(up to 3 timings are used)
Reagent pipetting volume
Remaining reagent volume control
70
5–15 °C
70 (plus 10 in reagent manager)
5–15 °C
60
5–12 °C
–
–
R1: 5.4 s
R2: 118.8 s
R3: 313.2 s
10 packs
12 packs
R1: 5.4 s
R2: 118.8 s
R3: 313.2 s
–
10 packs
R1: 3.2 s
R2: 90.2 s
R3: 300.2 s
5–180 μ L, in 1 μ L increments (5–19 μ L: + 20 μ L water)
By LLD and automatic test countdown with each pipetting
By automatic test countdown with each pipetting
Table 9-7 Reagent system
Sampling system
c 701 o o
Serum/plasma
Urine o
CSF o
Supernatant o
Other c 702 o o
Serum/plasma
Urine o
CSF o
Supernatant o
Other
1.5–35 μ L, in 0.1 μ L increments
Pressure sensitive clot detection system
Capacitance sensing technology c 502 o o
Serum/plasma
Urine o
CSF o o
Supernatant o
Whole blood
Other u
For information about sample containers and dead volumes, see:
Specifications of container types (p. 213)
Roche Diagnostics
220 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications
Photometric modules
Photometric measuring system
Light source
Photometer
Wavelengths
Optical path length
Optical range
Linearity
Optical mode
Table 9-9 Measuring system c 701 c 702 c 502
Halogen lamp, 12 V / 50 W
Multiple wavelength spectrophotometer
12 wavelengths available:
340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700, 800 nm
5.6 mm
0.0000–3.3000 absorbance
Up to 2.5 absorbance
Monochromatic and bichromatic
Roche Diagnostics
Operator’s Manual · 4.2.1
221
9 Specifications cobas e 602 module
cobas e 602 module
cobas® 8000 modular analyzer series
The following specifications apply to the e 602 module: u
For more information, see:
Reaction system
Applications
Test principals
Reaction volume/test
Throughput
Reaction disk
Incubator temperature
Reaction times
Cycle time
Mixing method
100 heterogeneous immunoassays
Competitive tests, sandwich tests
Nominal: approx. 200 μ L
Real: approx. 160 μ L
Up to 170 tests/h
54 positions
Carryover-free reaction as AssayCups only used once
37 °C ± 0.3°C (98.6 °F ± 0.5 °F)
9 min, 18 min and 27 min assays
21 s per module, 42 s per channel
Non-invasive vortex mixers
Sampling system
Sample types
Sample pipetter principle
Sample pipetting volume
Sample detection
AssayTips
AssayCups
Magazine loading capacity
Serum, plasma, urine, other
Conductive disposable tip handling
Carryover-free pipetting as AssayTips only used once
Nominal: 10–50 μ L
Real: 8–40 μ L
Liquid level detection (LLD) and clot detection
84 tips / magazine
84 cups / magazine
Up to 12 loaded magazines are possible with
1008 AssayCups and 1008 AssayTips
200 μ L Dead volume of calibrator and control vials u
For information about sample containers and dead volumes, see:
Specifications of container types (p. 213)
Roche Diagnostics
222 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 9 Specifications cobas e 602 module
Reagent system
Reagent disk temperature
Reagent disk capacity
Reagent pipetting volume
Microbead consumption
ProCell consumption
CleanCell consumption
PreClean consumption
Reagent volume control
Positive reagent identification
Automatic dilution
Evaporation protection
Inventory control
Waste handling ( e 602)
Solid waste handling
20 °C ± 3 °C (68 °F ± 5.4 °F)
25 cobas e packs in 25 positions
Nominal: 40–64 μ L/test dependent upon the assay
Nominal: 24–40 μ L/test dependent upon the assay
≤ 2.0 mL/cycle
≤ 2.0 mL/cycle
(CleanCell is used less than ProCell)
≤ 550 μ L/pre-wash
By test countdown on a software basis
2-dimensional barcode (PDF417)
Available
Reagents are automatically opened and closed
Available
Two waste boxes for used AssayTips and AssayCups
(max. 672 per box) and the magazine waste section for magazine waste (max. 12 magazines).
ECL measuring system
Measuring method
Measuring cells
Calibration mode
Test protocols
Auxiliary reagents temperature
Detection unit temperature
Pre-wash station temperature
Integral measuring of an electrochemiluminescence
(ECL) signal
2 individually calibrated ECL measuring cells two-point calibration
26 test methods
28 °C ± 2 °C (82.4 °F ± 4 °F)
28 °C ± 0.3 °C (82.4 °F ± 0.5 °F)
20 °C ± 1 °C (68 °F ± 2 °F)
Roche Diagnostics
Operator’s Manual · 4.2.1
223
9 Specifications cobas e 602 module cobas® 8000 modular analyzer series
Roche Diagnostics
224 Operator’s Manual · 4.2.1
Operation instrument
cobas® 8000 modular analyzer series
Table of contents
Safety information for operation
10 Safety information for operation
10
This chapter contains safety information relevant when running the cobas 8000 instrument. Be sure that you read and observe this safety information.
In this chapter
Chapter
10
Roche Diagnostics
Operator’s Manual · 4.2.1
227
10 Safety information for operation
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
228 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 10 Safety information for operation
General information
General information
Relevant safety messages for operation r Make sure that you have read and understood the chapter
(p. 21). The following safety messages in particular are relevant:
r Warning messages: o
Electrical shock from electronic equipment (p. 27)
o
Infection from samples and associated materials (p. 27)
o
Infection and injury due to sharp objects (p. 27)
o
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
o
Infection from waste solution and solid waste (p. 28)
o
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r Caution messages: o
Personal injury due to contact with moving parts (p. 30)
o
Incorrect results due to incorrect reagent volume (p. 30)
o
Incorrect results and interruption of analysis due to contaminated samples (p. 31)
o
Incorrect results due to evaporation of samples or reagents (p. 31)
o
Incorrect results due to carryover (p. 31)
o
Fatigue due to long hours of operation (p. 33)
o
r Observe the safety labels illustrated in section
Safety labels on the instrument (p. 35).
Before starting to work with the instrument, read the following safety messages carefully. If you ignore these safety messages, you may suffer serious or fatal injury.
Safety messages (overall system)
WARNING
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in personal injury and infection.
r Whenever possible, keep all covers of the analytical modules closed.
r Do not open any cover while the module is operating.
r Do not touch any parts of the instrument other than those specified.
r Observe all instructions given in this manual very carefully.
r Observe in particular the following safety labels on the instrument:
T-14 (p. 39); T-14 (p. 39), T-16 (p. 39), T-18 (p. 39);
F-1 (p. 41), F-2 (p. 41), F-4 (p. 41),
R-1 (p. 45), R-3 (p. 45), R-7 (p. 45);
Roche Diagnostics
Operator’s Manual · 4.2.1
229
10 Safety information for operation
Safety messages (overall system)
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION cobas® 8000 modular analyzer series
Interruption of operation due to interlock system
The interlock system senses opening of the monitored covers and immediately stops operation by cutting off the power. All pipetted samples are lost and must be reloaded.
Interlock covers are: The plexiglass cover above the sampling mechanism ( c 701 / c 702) and the top cover ( c 702 and c 502).
r Before starting operation or maintenance, be sure to close and lock all covers.
Operation will not start if an interlock cover is open. u
See:
r Do not open interlock covers during operation. Open the interlock covers only when the module is in Standby or when specifically instructed to do so in the maintenance procedures.
r Observe in particular the following safety labels on the instrument:
Injury or damage to the instrument due to contact with rack transfer mechanism
The rack transfer mechanism may hurt you and lead to personal injury.
r Only load or unload racks when the green status LEDs at the rack loading area are on.
r Do not insert your fingers or any objects into the rack loading/unloading area while the instrument is operating.
r Keep all covers closed and in place while the instrument is operating.
r Observe in particular the following safety labels on the instrument:
Incorrect results due to sample contamination
If foreign material falls inside the rack loading area, samples may get contaminated.
r Keep the cover of the rack loading area closed while the instrument is operating.
r Do not place anything on the cover of the rack loading area.
Incorrect results due to expired reagents or mixing reagents
Results obtained using expired reagents are not reliable. Mixing new reagent and residues of old reagent may cause concentration changes or carryover, leading to incorrect results.
r Do not use reagents, diluents or detergents that have exceeded their expiration dates.
r Do not replenish reagents, diluents, or detergents. When a container is empty, replace it with a new one.
Incorrect results due to sample mismatch in non-barcode mode r When operating in non-barcode mode, make sure to load the samples according to the
Requisition List provided by the instrument.
r Avoid empty positions within the racks. Do not place nonregistered samples in any empty rack position.
r When manually assigning positions, ensure the position is not already assigned.
Incorrect results due to incorrect definition of sample cup size
When using standard cups or micro cups, the correct sample cup size must be selected.
Otherwise, the sample pipetting may be inaccurate and thus lead to inaccurate measurement results.
r Be sure to specify the sample cup size for standard cups and micro cups.
Roche Diagnostics
230 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
NOTICE
10 Safety information for operation
Safety messages (cobas ISE module)
Injury to fingers by top cover dropping suddenly
Be careful when opening or closing a top cover. If you let go of the handle, the top cover may drop onto your fingers.
r Always keep a firm grip on the handle and do not let go when opening or closing a top cover.
r If a top cover does not stay open properly, please contact your local Roche service representative.
Data loss due to erroneous operation or instrument troubles
Data may get lost due to aging of the hard disk or due to a hard disk failure because of electric power failure.
r Back up your data (measurement results and system parameters) at regular intervals.
u
See
Archiving data and performing data backups (p. 504).
Safety messages (cobas ISE module)
CAUTION
Incorrect results due to missing covers of the ISE module
If the covers of the ISE measuring compartments are not reinstalled after maintenance, the temperature level or the noise level may be affected, leading to incorrect results. Touching any ISE component or opening the front doors may also affect the noise level and lower measurement precision.
r Only perform measurement if the covers of the ISE module are installed.
r Before opening or closing the cover of the ISE measuring units, make sure the module is in Standby or powered off.
r Do not touch components of the ISE module during measurement.
Roche Diagnostics
Operator’s Manual · 4.2.1
231
10 Safety information for operation
Safety messages (photometric modules)
Safety messages (photometric modules)
cobas® 8000 modular analyzer series
WARNING
WARNING
CAUTION
CAUTION
CAUTION
NOTICE
Infection due to contact with splashes of reaction solution or by inhaling reaction solution aerosol from the ultrasonic mixer r Keep all covers closed and in place while the instrument is operating.
Infection and injury when the top cover is open (c 702 only)
Contact with the reagent pack transfer mechanism or other mechanisms of the c 702 module may result in personal injury or infection. Therefore, the top cover is locked when the transfer mechanism moves.
r Before opening the c 702 top cover while the module is in Standby, check the
Reagent Manager Overview window to make sure that there are no reagent packs inside the buffer rotor of the reagent manager.
r Keep the top cover closed whenever possible. Otherwise, reagent packs cannot be loaded.
r Before starting operation or any software-controlled maintenance, be sure to close the top cover of the c 702 module. Otherwise operation would not start.
Incorrect results due to wrong temperature of the incubator
Measuring before the incubator has reached the correct temperature may lead to incorrect results.
Measuring with open top cover or reagent disk cover may lead to abnormal temperature control, which may also cause incorrect results. r Before starting any measurement, check that the incubator has reached the correct temperature (37 ± 0.1 °C) on the Overview menu. This may take up to 30 minutes after switching on the instrument, depending on the ambient temperature.
r Be sure to close the covers before starting analysis.
Incorrect results due to aspiration of air
Incorrect pipetting of the probes as well as incorrect adjustment of the probe position may result in aspiration of air, leading to incorrect results.
r Check the instrument performance by measuring QCs.
r Perform maintenance procedures regularly.
Incorrect results due to incorrect mixing volume
The permissible volume of reaction solution to be mixed by the ultrasonic mixer is 100 to
250 μ L. If the volume is outside this range, the reaction solution may not be mixed correctly, leading to incorrect results.
r Make sure that the volume of reaction solution stays in the range of 100 to 250 μ L, especially when loading a new application onto the instrument. r For information on analytical parameters of each reagent, contact its manufacturer.
Damage to the instrument (c 502 module)
Excessive weight on the foldable table of the c 502 module may lead to damage.
r Do not place anything other than reagent packs upon the table.
r Maximum load of the table is 2 kg.
r Observe in particular the following safety labels on the instrument:
Roche Diagnostics
232 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 10 Safety information for operation
Safety messages (cobas e 602 modules)
Safety messages (cobas e 602 modules)
CAUTION
CAUTION
NOTICE
Incorrect results due to missing covers of the e 602 reagent compartment or the incubator
If the covers of the reagent compartment or the incubator are not reinstalled after maintenance, the temperature may become inaccurate, leading to incorrect results.
r Only perform measurement when the covers are closed.
r Observe in particular the following safety labels on the instrument:
Incorrect results due to foam on the surface of the ProCell/CleanCell reservoirs r Before start of analysis, check that no foam has been accumulated on the surface of the e 602 ProCell/CleanCell reservoirs.
r Clean the ProCell/CleanCell reservoirs if foam has been accumulated.
u
See
Cleaning ProCell/CleanCell nozzles and replace reservoirs (p. 768).
Damage to the instrument
Excessive weight on the magazine drawer of the e 602 module may lead to damage.
r Do not open the front door of the magazine drawer and do not pull out the magazine drawer when the green status lamp is off or blinking.
r Pull out the magazine drawer gently and do not lean on the magazine drawer.
r
Observe in particular the following safety label on the instrument: F-13 (p. 42).
Roche Diagnostics
Operator’s Manual · 4.2.1
233
10 Safety information for operation
Safety messages (cobas e 602 modules) cobas® 8000 modular analyzer series
Roche Diagnostics
234 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Software basics
11 Software basics
11
This chapter is an introduction to the basic operational procedures for the cobas 8000 instrument.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
11
235
11 Software basics
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
236 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Graphical user interface
Graphical user interface
q The screens shown in this chapter and throughout this manual are for illustration only. The screenshots do not necessarily show valid results.
The cobas 8000 modular analyzer series is operated by using a graphical user interface (GUI) that is presented on the monitor screen. This allows examination of data and/or controlling the system menu tabs .
This chapter provides an overview of the graphical user interface.
The graphical user interface of the instrument software is divided into two different main areas. The first area is the: o
Menu and data area and is used for daily operation. Depending on the selected menu, the content of this area changes.
The content of the second main area is consistent throughout the software and contains the following information: o
Status line o
Help buttons o
Global buttons
Presented below is an general example that shows the different areas.
B C
A D
Roche Diagnostics
Operator’s Manual · 4.2.1
A Menu and data
B Status line
Figure 11-1
C
D
Help buttons
Global buttons
Areas with different functions on the graphical user interface
237
11 Software basics
Graphical user interface cobas® 8000 modular analyzer series
Areas of the graphical user interface
This chapter provides information about the menu and data area and the guidance prompt area at the bottom of the graphical user interface.
Menu and data
The menu and data area is the main part of the graphical user interface.
We recommend reading the chapter
Software design and functionality (p. 257) first, if
you are not familiar with these concepts.
u
See Software design and functionality (p. 257)
The software can be operated via touch screen, mouse or keyboard.
u
For information about operation with the keyboard, see
Guidance prompt
At the lower left of the graphical user interface, a small line containing informative text, is available.
This line of text is called guidance prompt .
Here, the instrument software indicates any kind of information to enter or/and what format to use. For example, “Touch screen or press Enter ”.
Every guidance prompt is specific to the location of the cursor.
Roche Diagnostics
238 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Graphical user interface
Information outside of the menu and data area
Information and functions outside of the menu- and data area are always accessible: o
The status line provides information about the current system condition.
o
Help provides two different types of functions:
O
A direct help that is specific to the selected element will appear depending on the current cursor position.
O
A F1 Help that is specific to the current window will open a window offering a table of contents.
u
For more information about the help, see
The help system of the instrument (p. 249).
o
The global buttons allow control of common system functions, for example starting and stopping the system.
Status line
The status line displays the current status of the instrument (operating mode), the operator ID, date and time.
Depending on the status, additional information can be displayed, such as the remaining time when performing maintenance, or the remaining time for rack reception mode.
Help buttons
The direct help button (question mark button) will add a question mark to the cursor.
When you click on an element, a popup window will appear providing information about this element.
The Help button will open a new dialogue window that displays the context-sensitive
Online Help of the instrument. The content of this Operator's Manual is also included in the help file. To simplify the use of this electronic manual, topics are connected via hyperlinks for more information.
u
For information about using the help buttons, see
The help system of the instrument (p. 249).
Roche Diagnostics
Operator’s Manual · 4.2.1
239
11 Software basics
Graphical user interface
Global buttons cobas® 8000 modular analyzer series
To stop operation, e.g., a running analysis or maintenance procedure.
All results currently being processed will be lost.
To log off the operator.
To stop further sample processing.
After confirmation, the instrument goes into S. Stop (sampling stop) mode and reacts in the following way: o
New racks are not loaded onto the instrument.
o
Sample processing from racks in the analyzer modules is continued. When sampling is completed, the racks are moved to the rack unloading area.
o
Racks in the module sample buffers are not processed but moved to the rack unloading area automatically.
When all racks have been moved to the unloading area, the instrument goes into Standby.
To display the alarm list and the remedies. If an alarm was issued, the Alarm button flashes yellow or red.
To view the calibration, QC and patient reports.
To print information, e.g. the Result List , Requisition List , Calibrator Load
List , QC Load List , or maintenance reports.
To select Start condition settings and to start analysis.
Global buttons at the right side of the graphical user interface are always available during daily operation. The Stop , S. Stop , and Start buttons are also the system control buttons .
The global buttons can be selected by touch screen, mouse, or keyboard.
u
For information about operation with the keyboard, see
Roche Diagnostics
240 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Graphical user interface
Workflow for daily operation
When working with the cobas 8000 instrument, the main approach is to start all routine operations from the Overview menu.
Figure 11-2 The Overview menu – the main menu
This menu provides access and control for all modules of the instrument irrespective of its individual configuration.
Work Flow Guide
As a basic operating strategy, we recommend using the Work Flow Guide as a guidance.
The order of the buttons from left to right will reflect the steps to follow before operating the system.
Red , yellow or purple colored buttons indicate the need for operator intervention .
Choosing a colored button will open a dialogue window to perform a step. The Daily
Maintenance button is a shortcut to the Maintenance submenu.
u
For more information, see Pre-routine operation (p. 276).
Main menus and Overview menu
To access any data or perform any action on the system, two different areas are available: o
Main menus - including the Overview menu.
o
Module overview .
To access any main menu, select the related tab .
Navigate from here to access details of the cobas 8000 instrument.
u
For more information about the main menus, see
Main menus in detail (p. 244).
Roche Diagnostics
Operator’s Manual · 4.2.1
241
11 Software basics
Graphical user interface
Submenus cobas® 8000 modular analyzer series
Main menus will guide you into main subject areas. Every main menu is further more structured into submenus .
u
For a submenu overview, see figure 11-3 .
Menu restrictions Access to some submenus and windows, especially those of the Utility menu, are restricted by individual user levels . Therefore some submenus may not appear as presented here.
Module Overview area
To access any instrument module, select the related symbol button .
Symbol buttons allow direct access to individual modules. Choosing a symbol button opens, for example, the Reagent Overview window of the corresponding module.
u
For an overview about the Symbol buttons, see figure
.
For detailed information about this area and the meaning of the different buttons, please refer to the Online Help of the Overview menu.
Roche Diagnostics
242 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Graphical user interface
Menus overview
Workplace
Test Selection
Data Review
Calib. Review
Reagent
Presented below is an overall view of all main menus and its related submenus that are available:
Calibration QC Utility Overview
Setting
Status
Main menus and related submenus
Status
Calibrators
Install
Status
Run Status
Controls
Install
System
Maintenance
Application
Special Wash
System
&RQÀJXUDWLRQ
Always start from the Overview menu
Rack Loader /
Unloader
ISE F¬F F¬ H¬
Module Overview Sample Tracking Reagent Overview
ISE
Reagent Overview
F¬F
Reagent Overview
F¬
Reagent Overview
H¬
Figure 11-3 Accessing data and control in detail
Standard software components like buttons, menu tabs and windows are used on each menu screen. If you are not familiar with these components, we recommend
that you read the chapter Software design and functionality (p. 257) first.
u
See Software design and functionality (p. 257)
Roche Diagnostics
Operator’s Manual · 4.2.1
243
11 Software basics
Graphical user interface
Main menus in detail
cobas® 8000 modular analyzer series
This chapter provides a detailed view of the graphical user interface .
Some screen tabs for each main menu are presented in this section.
Workplace
The Workplace menu offers three submenus: o
Test Selection o
Data Review o
Calib. Review
Roche Diagnostics
244
Figure 11-4 Workplace menu
These submenus are used to perform the following tasks:
Test Selection o
To program test selections manually o
To enter patient demographics o
To assign patient ID numbers and positions to samples with a barcode error or no barcode label.
Data Review o
To review, backup, edit, delete and/or send and print sample and QC results
Calib. Review o
To review the status of used calibrators during operation q The terms data and results are used interchangeably in the user interface and in this document.
u
For more information, see:
Test Selection submenu (p. 301)
Calib. Review submenu (p. 323)
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reagent
The Reagent menu offers two submenus: o
Setting o
Status
11 Software basics
Graphical user interface
Figure 11-5 Reagent menu
Setting and Status submenus These submenus are used to perform the following tasks: o
To view detailed reagent information o
To perform tasks related to reagent management u
For more information, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
245
11 Software basics
Graphical user interface
Calibration cobas® 8000 modular analyzer series
The Calibration menu offers three submenus: o
Status o
Calibrators o
Install
Roche Diagnostics
246
Figure 11-6 Calibration menu
These submenus are used to perform the following tasks:
Status o
To view recommended calibrations o
To determine the Start Up calibration o
To manually request a calibration o
To cancel or edit a calibration request o
To reject a calibration o
To view calibration trace, calibration result or reaction monitor
Calibrators o
To assign a calibrator to a rack and position
Install o
To download a new calibrator from the data manager o
To download a new lot of calibrator to the system o
To manually add a new calibrator o
To manually edit calibrator values o
To delete a calibrator from the system u
For more information, see:
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
QC
The QC menu offers four submenus: o
Status o
Run Status o
Controls o
Install
11 Software basics
Graphical user interface
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 11-7 QC menu
These submenus are used to perform the following tasks:
Status o
To view routine and Stand By Bottle QC test selections o
To manually order control test selections o
To select Routine QC on all active reagents o
To manually order specific Stand By Bottle QC o
To unload Auto QC racks
Run Status o
To view all processed controls evaluated against the appropriate SD range
Controls o
To assign a rack and position to a control
Install o
To download a new control from the data manager o
To download a new lot number of an existing control from the data manager o
To inactivate or activate tests for controls o
To delete a control from the system u
For more information, see:
247
11 Software basics
Graphical user interface
Utility cobas® 8000 modular analyzer series
The Utility menu offers five submenus: o
System o
Maintenance o
Application o
Special Wash o
System Configuration
These menus are used to enter system parameters, application parameters, maintenance settings and system settings.
Roche Diagnostics
248
Figure 11-8 Utility menu u
For more information, see:
Performing maintenance items (p. 594)
System Configuration submenu (p. 573)
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
The help system of the instrument
The help system of the instrument
The software of the cobas 8000 instrument has a context-sensitive online help system to support you in operating the instrument.
Context-sensitive means that the help system always displays information related to the current window or software element. Therefore, the help system offers a quick and convenient way to find information.
The user interface of the cobas 8000 instrument offers two help features: o
F1 Help, which is the main help feature, and o
Direct Help (tooltips).
A B
A Direct Help button
B F1 Help button
Figure 11-9 Online help buttons u
For more information on F1 Help, see:
Searching for information in the help system (p. 253)
Printing F1 Help topics (p. 256).
u
For more information on Direct Help, see:
About F1 Help
This help feature displays information related to the current window . Hypertext links guide you to additional information and procedures related to this window.
The name F1 Help results from the fact that this help is also available by pressing the
F1 key.
q Operator's Manual included in the F1 Help system
The Operator's Manual is included in the F1 Help system. This allows you to search for information throughout the software reference and the manual. All cross-references are implemented as hyperlinks.
p To display the F1 Help feature for the current window
1 Open the menu or window for which you want detailed information.
2 Choose the Help icon in the top right corner of the screen or press the F1 key on the keyboard.
The help window opens displaying the desired help information. s
Roche Diagnostics
Operator’s Manual · 4.2.1
249
11 Software basics
The help system of the instrument
The F1 Help window
cobas® 8000 modular analyzer series
The F1 Help window comprises three main areas: o
o
o
A
B
C
Button bar
A Button bar
B Navigation pane
Figure 11-10
C Topic area
Areas of the F1 Help window
(example screenshot from the English version)
The buttons at the top of the help window provide the following functions:
Hide / Show
Previous / Next
Allows you to show or hide the navigation pane. This feature provides more space in the topic area, which may be desired for displaying large figures.
Use these buttons to open the topic above or below the current topic. If there is no topic to view above, the Previous button is unavailable.
Back / Forward
Refresh
Use these buttons to backtrack through the topics you have previously reviewed, in the order in which you viewed them.
The record of topics viewed is deleted each time you exit the
F1 Help.
This is a standard function of Internet browsers for refreshing the screen. You do not need this button to display the F1 Help.
Prints the topic currently displayed in the topic area.
Help
Directs you to information about the help system ( help on help ).
Roche Diagnostics
250 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Navigation pane
11 Software basics
The help system of the instrument
The navigation pane appears to the left of the help window. There are four tabs available at the top of the pane: Contents , Index , Search , and Favorites .
o
The Contents tab uses book and page symbols to display the contents of the
F1 Help and remains synchronized with the topic displayed in the topic area.
o
The Index tab provides access to the help index.
o
The Search tab provides access to a full-text search feature.
o
The Favorites tab allows organizing important topics with your personal bookmarks.
Figure 11-11 The tabs in the Navigation pane u
For information on the Contents , Index , Search , and Favorites tabs, see:
Searching for information in the help system (p. 253)
Roche Diagnostics
Operator’s Manual · 4.2.1
251
11 Software basics
The help system of the instrument
Topic area cobas® 8000 modular analyzer series
Help topics appear in the area to the right of the navigation pane. The topic area comprises the description related to the topic selected in the navigation pane.
If the topic extends beyond the window, scrollbars allow you to view the rest of the topic.
C
A B
A Related topics at the end of the topic
B Links
Figure 11-12
C Scrollbar (if necessary)
Topic area (example screenshot from the English version)
Related topics At the end of a topic, all subtopics to the current topic are listed.
Alternatively, you can navigate to subtopics using the Next button or using the
Contents tab.
Links Cross-references to associated topics are indicated by blue text. When you hover over a link, the mouse pointer changes to a hand icon. u
For information on the symbols used in the topic area, see:
Conventions used in this document (p. 12).
Roche Diagnostics
252 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
The help system of the instrument
Searching for information in the help system
There are various methods of finding the desired information in the F1 Help. Select your preferred method. o
The Contents tab displays the structure and contents of the cobas 8000 help system allowing you to navigate to the desired location. o
The Index tab displays a list of predefined keywords based on the topic titles and words or phrases in the help system. o
The Search tab allows you to perform a full-text search in the help system.
p To use the Contents tab
1
Choose the Help icon in the top right corner of the screen or press F1.
The help window displays information related to the current window of the user interface.
2
If you require information about another topic , use the navigation pane on the left: o
Double-click on a book symbol to further expand the contents structure (or click on the plus symbol ). The structure in the navigation pane expands showing the available topics.
o
Click on a book symbol or a page symbol to display the corresponding topic .
o
Use the scrollbar of the navigation pane to scroll up and down within the topics of the help system.
s p To use the Index tab
1
In the help window, choose the Index tab to display the list of index entries.
2
Type the desired index entry or scroll through the index list. As soon as you start typing the index entry, the entries that most closely match the text that you type are displayed in the index list.
3
When you have found the desired index entry, double-click the entry or select the entry followed by Display to display the topic in the topic area.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
253
11 Software basics
The help system of the instrument cobas® 8000 modular analyzer series p To use the Search tab
1 In the help window, choose the Search tab.
Figure 11-13 Search tab
2 In the text box, type the search term(s) you want to find.
3 Choose the List Topics button to show the search results.
4 The bottom list displays the titles of topics that match the search term(s).
5 Double-click a topic title to display this topic in the topic area.
Or: Select the topic title and choose the Display button.
u
See:
Search options and recommendations (p. 254)
s
Search options and recommendations
Search options The following table describes the search options in the help window:
Search option Explanation
AND
OR
NEAR
NOT
Search previous results
Use this option to join words or phrases when both (or all) terms must appear in the search results.
Use this option to join synonymous or related terms when either (or both) of the terms must appear in the search results.
Use this option to find words within 10 words of each other.
Use this option to exclude a particular word or combination of words from your search results.
Select this check box to limit the search results and search through your results list from previous search.
Clear this check box if you want to search through all of the files in the Online Help.
Match similar words
Search titles only
Table 11-1
Select this check box to find similar words and minor grammatical variations for the phrase you search.
Select this check box to search titles only.
Clear this check box for a full text search.
Search options
Roche Diagnostics
254 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
The help system of the instrument
Recommendations for better search results
The number of search results is displayed above the result list ( Found: xx).
Problem Recommendation
Too many search results 1. Select the Search titles only check box.
2. Clear the Match similar words check box.
3. Select the Search previous results check box and enter a new search term(s) that is associated with your desired information.
4. Connect two or more search terms with AND , OR ,
NEAR , or NOT (see arrow button on the right of the text box).
The desired information is not contained in the search results
Table 11-2
1. Select the Match similar words check box.
2. Clear the Search previous results and the Search titles only check boxes.
3. Maybe you are using terms that are different from the terms used in the help system. Use the Index tab for your search.
Recommendations
Using favorites
You can add a favorite, also called bookmark, to online help topics that you want to visit again. The favorites work similar to the favorites in your web browser.
p To add a favorite
1 In the help window, search for or navigate to the desired topic.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 11-14 Favorites tab (example screenshot from the English version)
2 Choose the Favorites tab to display the list of favorites.
The topic title is displayed in the Current topic text box.
3 To rename the topic, enter another name.
255
11 Software basics
The help system of the instrument cobas® 8000 modular analyzer series
Printing F1 Help topics
You may find it useful to print a topic from the cobas 8000 Online Help.
p To print a help topic
1 In the help window, search for or navigate to the desired topic.
2 To print the current topic, choose the Print button.
3 Check the printer settings and choose Print to print the selected topic.
s
About Direct Help
q
4 Choose the Add button. The new favorite is inserted in alphanumeric order.
Any time you want to open that topic again, choose the Favorites tab and then select it from the Topics list.
Organizing favorites by prefixes
To organize a number of favorites, we recommend using a numeric prefix at least for each main menu (e.g., 1 = Workplace , 2 = Reagent , …). All topics from the
Workplace menu will then appear together under the prefix 1 .
s p To rename a favorite
1
In the Favorites tab, select the desired favorite.
2
Right-click on the favorite’s name and select Rename .
3
Type the new name and press Enter.
s
Direct Help displays a short information related to a single software element, such as a button or text box. Use this help feature if you require a tooltip about this element.
q The Direct Help can only provide short tooltips
If you require more information about an element, please press the F1 key to open the
F1 Help system. p To call-up the Direct Help feature for a single element
1
Touch (or click) the Direct Help icon in the top right of the screen.
2
Wait until a question mark ( ?
) is displayed next to the pointer.
3
Touch the screen element for which you want detailed information. A tooltip
(pop-up window) is displayed containing information about this screen element.
4
Touch any part of the screen to close the pop-up.
s
Roche Diagnostics
256 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Software design and functionality
Software design and functionality
This chapter presents some basic information about the software structure of the graphical user interface (GUI) and how to use it.
Mouse or touch screen
The graphical user interface offers two methods for operators to interact with the system in order to enter data or control the status of an individual function.
This can be done by interacting directly with the touch screen or indirectly, by using the mouse to control the cursor position. In both methods the resulting functionality is the same.
Screen basic interactions
To enter data Touch screen : Touch the desired area within the text field on the screen.
Mouse : Move the cursor across the desired area within the text field and click.
To change a function Touch screen : Touch the desired area on the screen. Depending on the status of the function, it changes its status. For example, if a function was enabled before, it is disabled after it was chosen.
Mouse : Move the cursor across the desired area on the screen and click. Clicking will change the status of that function.
To select a single data line Touch screen : Touch the desired line on the screen. The affected line changes color in order to indicate that the action of the operator was accepted.
Mouse : Move the cursor across the desired line and click.
Screen advanced interactions
To select a range of data lines If a range of consecutive lines is to be selected, click the upper (or lower) line of the proposed range , hold down the shift key on the keyboard and click the last (or first) line of the proposed range. All lines of the selected range will change color.
Mouse : Perform in the same manner as described for the touch screen.
To select several individual data lines
If non-consecutive lines are to be selected, select the upper (or lower) line of a line range , click this line, press the CTRL key on the keyboard and select all additional lines of the desired selection. All selected lines will change color.
Mouse : Perform in the same manner as described for the touch screen.
Roche Diagnostics
Operator’s Manual · 4.2.1
257
11 Software basics
Software design and functionality
Software elements
cobas® 8000 modular analyzer series
The following illustrations (Figures
up to
11-28 ) present more detailed software
functions which are necessary when working with the system.
Menu and submenu
A
B
A Menu
Figure 11-15 GUI elements 01
B Submenu
Menu A menu is the top element of a hierarchical structure.
Submenu tab Related to a menu, a submenu is one level lower and offers detailed information about the system.
Roche Diagnostics
258 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Parameter group, list box and tab
A
B
C
11 Software basics
Software design and functionality
A Tab - examples
B List box to select an item or a property
Figure 11-16 GUI elements 02
C Parameter group
Menu tab Any selected menu is highlighted in dark gray.
Submenu tab The submenu tab selected is indicated by a light gray background with a blue border.
Parameter group As part of a submenu, parameter groups are used to perform individual settings to configure the cobas 8000 instrument according to individual needs. Additionally, every parameter view is split into smaller areas .
List box
List boxes are used to specify the content of a parameter group. The figure 11-16
demonstrates how to select the property of a test application such as: o Analyze - as selected in the list box o
Calib.
o Range o
Other o Formula
Roche Diagnostics
Operator’s Manual · 4.2.1
259
11 Software basics
Software design and functionality
Window and area
Window cobas® 8000 modular analyzer series
Area
Figure 11-17 Example of a window
Usually, the system uses a window to interact with the operator, for example for requesting a calibration.
When all entries have been made, the operator must confirm his action by choosing a button like Yes , No , OK , Save , Close or Update . Afterwards the window is closed.
Buttons
Figure 11-18 Example of an area
An area describes a smaller range of a menu or window that distinguishes information to a topic from other topics.
Buttons are used to execute functions, confirm entries and selections, and display pop-up windows.
The number of buttons depends on the submenu that is active.
The function of a gray shaded button is unavailable at the moment. It is available again after certain activities in the related submenu.
Some buttons are called radio buttons. Choosing a radio button will activate or deactivate a function.
Roche Diagnostics
260 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Software design and functionality
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Buttons with radio button function
B Standard button disabled
Figure 11-19 Examples of buttons
C Standard buttons
The following buttons are used throughout the software. These buttons are explained below.
Accept the changes and entries made in a window and close the window.
Close the window without saving the changes and entries made in a window.
Accept the changes made in a window, execute the action of the window (e.g., Delete) and close the window.
Close the window without saving the changes made in a window or without executing the function of the window (e.g., Delete).
Close the window.
Save the changes made to the submenu/window currently displayed. When changes have been made, this button turns yellow.
Update the changes made to the submenu/window currently displayed. When changes have been made, this button turns yellow.
Accept the changes made in a window, execute the action of the window and close the window.
B
C
261
11 Software basics
Software design and functionality
Lists cobas® 8000 modular analyzer series
Lists are used to display a collection of items , such as tests or reagents. If there are more list items than fit in the list frame, a scroll bar is displayed.
It is possible to select one or more individual line(s) inside a list. Many lists allow selecting multiple lines at the same time. Once a line or range of items is selected, an action can be performed (i.e., printing sample and QC reports or backing up data to a
DVD).
B
A
B
List box
A List
Figure 11-20
B Scroll bars
Example of a list and scroll bars
A list box displays a list of items the user can select. Several types of list boxes are available. Presented below is a list box in Calibration > Status .
A
Roche Diagnostics
262
A List box
Figure 11-21 Example of a list box as part of a submenu
Additionally, a list box can be contained within a list, specifying an additional parameter.
In the example below, an appropriate calibration method for an individual test can be selected: None, Blank, 2Point, or Span.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Software design and functionality
A
A List box
Figure 11-22 Example of a list box within a list
Selecting lines To select an item in a list box, move the cursor onto the line of your choice and click on this line. To select multiple lines in a group , hold down the shift key and select the required range of lines . To select multiple individual lines , as shown in the example below, hold down the CTRL key and select all required lines.
A
A Selected lines
Figure 11-23 Example of a list with four individual lines selected
Roche Diagnostics
Operator’s Manual · 4.2.1
263
11 Software basics
Software design and functionality
Text boxes and fields cobas® 8000 modular analyzer series
If the system needs any intervention by the operator, either a text field as part of a submenu, or a dialog window will pop up, containing one or more text fields that can be used to enter information that is expected by the system.
Move the cursor across the text field of your choice and enter the appropriate information.
Setup functions
Check boxes
Figure 11-24 Example of a text box
Confirm your input by choosing the button Logon . The dialog window will close.
Many functions or conditions of the cobas 8000 instrument have to be controlled by the operator. This can be performed by selecting or clearing check boxes or options.
Check boxes are used to turn one or more option(s) ON or OFF . When an option is on, a check mark appears in the related box. Usually, a check box will allow you to select none , a minimum of one or multiple of many options.
Sometimes when an option is on, additional fields become available.
If available, it is possible to use multiple check boxes at the same time.
A
A Multiple check boxes
Figure 11-25 Example of multiple check boxes
Roche Diagnostics
264 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 11 Software basics
Software design and functionality
Confirming a check box
Data Initialization has been checked , confirm this action by choosing the OK button.
Options
Figure 11-26 Confirm the change in a check box
Options are very similar to the function of a check box. In contrast to a check box, it is not possible to select no function . Usually, it is common to make a selection between two options. But multiple options can be available as well.
Windows
Figure 11-27 Example of two options
An option is selected if a blue dot is displayed within the gray circle for this option.
Only one option can be selected at a time. In the example above, buttons are combined with option circles.
A window or a dialog window pops up across existing menus (or submenus).
Windows are used to communicate any dialog between the system and the operator, such as to select a function, enter a password or search for an archive file.
Figure 11-28 Example of a dialog window
Usually, the dialog window is closed by selecting a confirmation button.
Roche Diagnostics
Operator’s Manual · 4.2.1
265
11 Software basics
Shortcut keys
Shortcut keys
cobas® 8000 modular analyzer series
In addition using the mouse to work with the software, many system functions can be controlled by choosing single keys or key shortcuts. Using single keys or key shortcuts will speed up routine work.
All keys, key shortcuts and their functionality are described in this section.
Menus
Shortcut
F5
F6
F7
F8
F9
F12
Table 11-3
Description
Workplace menu
Reagent menu
Calibration menu
QC menu
Utility menu
Overview menu
Shortcut keys to display menus
Cursor control
Shortcut
Home
End
TAB
Shift + TAB
Page up
Page down
Description
Places the cursor at the beginning of a list or text box.
Places the cursor at the end of a list.
Moves the cursor to the next button or field.
Moves the cursor to the previous button or field.
Scrolls upward in a list, one page at a time.
Scrolls downward in a list, one page at a time.
Use the arrow keys to move the cursor in all directions.
Table 11-4
General functions
Shortcut
F1
Shift + Print
CTRL + F7
Pause
Enter
Shift + x
Back space
Space
Delete
Caps lock
Num lock
Table 11-5
Shortcut keys for cursor control
Description
Starts the context-sensitive online help system.
Displays the Print window.
Creates a screenshot of the current screen. The screenshot can be printed via Print > History .
Formats a DVD. See:
Displays the Logoff window.
Confirms any entry.
Pressing the Shift and a character key simultaneously will generate a capital letter or a special character.
Deletes a character to the left of the cursor.
Inserts a space left of the cursor position.
Deletes a character to the right of the cursor.
Locks the letter keys into the upper case mode.
Activates the numerical keypad to enter numbers and mathematical operators such as +, -, /, *.
General shortcut keys
Roche Diagnostics
266 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Global buttons and windows
)
)
)
)
3ULQW
)
Figure 11-29 Global buttons and their corresponding keys
11 Software basics
Shortcut keys
Roche Diagnostics
Operator’s Manual · 4.2.1
267
11 Software basics
Shortcut keys cobas® 8000 modular analyzer series
Roche Diagnostics
268 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Daily operation
12 Daily operation
12
This chapter provides you with a short description of a typical daily workflow when running the cobas 8000 instrument.
For more information about tasks that may also be performed during a shift, please
refer to the subsequent chapters in part Operation instrument (p. 225).
Please refer to the Online Help for details about each software submenu.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
12
Sampling Stop (S.Stop) status and Rack Reception Mode..................................... 289
269
12 Daily operation
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
270 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Workflow overview
Workflow overview
Daily operation comprises the routine tasks that are required to prepare the instrument, analyze samples, and maintain the instrument.
The following diagram provides you with an example of a workflow for daily operation.
'DLO\RSHUDWLRQ
6WDUWXSDQGGDLO\FKHFNV
‡6WDUWLQJWKHLQVWUXPHQW
‡9LVXDOFKHFNVDIWHUVWDUWXS
‡&KHFNLQJIRUV\VWHPDODUPV
3UH²URXWLQHRSHUDWLRQ
‡3HUIRUPPDLQWHQDQFHDFWLRQVQRZRULQVWHS
‡&OHDUWKHGDWDEDVHDQGRUEDFNXSGDWD
‡3UHSDUHUHDJHQWV
‡3HUIRUPFDOLEUDWLRQDQG4&
‡'RZQORDGSDUDPHWHUV
5RXWLQHRSHUDWLRQ
‡3URFHVVLQJVDPSOHV
‡6DPSOLQJ6WRSVWDWXV
‡&KHFNLQJUHVXOWV
/RDGQHZ
VDPSOHV
3RZHURIIDQGGDLO\FKHFNV
‡3HUIRUPLQJPDLQWHQDQFH
‡3RZHULQJRIIWKHLQVWUXPHQW
‡,QVWUXPHQWLQVSHFWLRQ
Figure 12-1 Example of a daily operation workflow q Configuration of the instrument
The instructions in this chapter are given assuming that all configurations are already set.
Roche Diagnostics
Operator’s Manual · 4.2.1
271
12 Daily operation
Start-up and daily checks
Start-up and daily checks
cobas® 8000 modular analyzer series
Starting the instrument comprises the following steps:
1.
Starting the instrument (p. 272)
2.
Visual checks after start-up (p. 274)
3.
Checking for system alarms (p. 275)
Before performing the following actions, observe these safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 229)
r
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
Starting the instrument
q Instrument inspection
Before starting the instrument, ensure the instrument inspection was already performed
(either before start-up or after the last power off) .
u
See Instrument inspection (p. 294).
The instrument can be programmed to start up automatically, or you can start it manually. After start-up, the instrument can automatically perform maintenance items if the Power Up Pipe function is configured. While the pipe is processed, some visual checks need to be performed.
q Start-up after extended power off (more than overnight)
If the e 602 modules have been powered off for 1–2 days or longer (e.g., a weekend),
follow the procedures described in chapter 24 Maintenance of cobas e 602 module
u
See: Extended power OFF and ON procedures (p. 801).
Automatic start-up
The instrument can be programmed for automatic start-up by the time switch at the front of the core unit.
u
See Setting the date and time (p. 487)
p To automatically start up the instrument
1 The instrument starts up automatically at the set time. While the instrument is performing initialization, the Logon window is displayed.
o
If the Alarm button on the right of the screen is flashing, check the Alarm window for important system alarms.
u
See
To review the Alarm window (p. 275).
Roche Diagnostics
272 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series o
If the Alarm
button is not flashing, go to step 2
.
12 Daily operation
Start-up and daily checks
Manual start-up
Figure 12-2 Logon window
2
Enter your Operator ID and Password and choose Logon .
At the end of initialization, the instrument processes the Power Up pipe if configured.
3
In this case, perform the visual checks while the pipe is being processed.
u
See
Visual checks after start-up (p. 274)
When initialization has been completed, the instrument goes into Standby.
s
If no automatic start-up has been set, use the following procedure to start up the instrument.
q Before starting the instrument, check that no manual maintenance is being performed.
Otherwise parts or tools may come into contact with moving mechanisms, which may lead to analyzer damage.
p To manually start up the instrument
1
Press the green Operation Power ON button, located at the front of the core unit.
The instrument begins with the initialization. The complete process may take approx. 9 to 10 minutes from switching on to Standby.
2
In the Logon window, enter your Operator ID and Password and choose Logon .
After the initialization is completed, the instrument processes the Power Up pipe if configured.
3
In this case, perform the visual checks while the Power Up pipe is being processed.
u
See
Visual checks after start-up (p. 274)
When initialization is completed, the instrument goes into Standby.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
273
12 Daily operation
Start-up and daily checks
Visual checks after start-up
cobas® 8000 modular analyzer series
After initialization, the Power Up Pipe function is usually programmed to execute a defined set of processes. The name of this set is freely definable. Daily pipe is the name that is used in this document.
While and after the Daily pipe is processed, some visual checks need to be performed.
Be sure to perform these checks prior to routine operation.
Visual checks
During the pipe
After the pipe (Standby)
Before starting analysis
Table 12-1 m
With top covers closed, visually check that water is being discharged at all rinse stations as well as through the sample probes and reagent probes.
m
During air purge, visually check the syringes and the tubing system for leakage and air bubbles.
m
Check the photometer values via Print (global button) > History > Data .
m
On the Overview menu, check that the incubator water temperature ( Reac.
) is within 37 ± 0.1 °C .
If the incubator water was exchanged, it can take up to 30 minutes for the incubator to reach the correct temperature.
Visual checks while and after the pipe is processed
Maintenance item
[module]
(6) Air Purge
[ISE, c 701 / c 702]
(6) Air Purge
[ISE, c 701 / c 702, c 502]
(3) Photometer Check
[ c 701 / c 702 / c 502]
(5) Incubation Water
Exchange
[ c 701 / c 702 / c 502] u
For information about the maintenance items recommended for the pipe, see:
Checks during operation r During operation, always check for any abnormal sound, water leaks or other abnormal condition. If a problem occurs, take suitable safety measures according to the condition and contact your Roche service representative or technical support.
Roche Diagnostics
274 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Start-up and daily checks
Checking for system alarms
If an alarm was issued, the Alarm button flashes. The color of this button indicates the alarm level: o
Yellow indicates a Caution level alarm; operation may be continued.
o
Red indicates a Stop level alarm; operation will be stopped on the corresponding module or the entire instrument, respectively.
When the Alarm button flashes, it is necessary to open the Alarm window to view the alarm. The Alarm window identifies all system alarm conditions.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 12-3 Alarm window q Order of alarms in the Alarm window
Alarms are displayed in chronological order with the newest one at the bottom. The list can be sorted by choosing one of the column headers.
p To review the Alarm window
1
Choose Alarm (global button) to display the Alarm window.
2
Select each alarm to view the description and remedies (displayed in the lower half of the screen).
3
Correct any alarm conditions by following the remedies.
If any problems arise, refer to the module-specific troubleshooting chapter.
u
See chapter 26 Troubleshooting (p. 875).
4
Choose Close to close the Alarm window.
s
275
12 Daily operation
Pre-routine operation
Pre-routine operation
cobas® 8000 modular analyzer series
Work Flow Guide for pre-routine operation
The Work Flow Guide area on the Overview menu guides you through operation steps. The first 4 buttons are placed in the suggested sequence of pre-routine operation. The last button – Sample Tracking – is used during routine operation.
Button
Table 12-3
Roche Diagnostics
276
Work Flow Guide
3UHURXWLQHRSHUDWLRQ
5RXWLQH
RSHUDWLRQ
Figure 12-4 Work Flow Guide on the Overview menu
If a button changes color to yellow or red, the corresponding action needs to be performed. If a button remains gray, that action is not necessary.
Color
Gray
Purple
Yellow
Red
Table 12-2
Explanation
Normal status: No action is required.
Reagent below daily requirement.
Attention: This action will be required soon .
Attention: This action is required immediately .
Explanation of the colors used in the Overview menu
Explanation
If this check box is activated, the software indicates what might be required during the shift: o
A Purple alarm is issued if a reagent’s volume is less than the daily requirement set under Utility
> System > Reagent Level .
o
Tests are recommended for calibration ( Calib.
Now ) if calibrations are due within the
Remaining Time set on the Calibration Status submenu.
The button changes color when maintenance is about to expire (available only if maintenance intervals are defined).
o
Maintenance interval is about to expire.
o
Maintenance interval has expired.
Use of the button
Select this check box during pre-routine operation (active by default after power on).
We recommend clearing the
Preventive Action check box before starting routine operation.
Choose this button to perform maintenance actions.
The button changes color when the sample database is almost full (max. 12 000 patient and QC samples).
Deleting sample data on the hard disk allows faster access to the data.
o
Sample database almost full (> 9400 samples)
Choose this button regularly to clear the database (the instrument must be in Standby).
We recommend performing a periodic backup of data.
o
Sample database is full
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Pre-routine operation
Button
Table 12-3
Explanation Use of the button
The button changes color to indicate that the level of a reagent is low: o
Reagent below daily requirement
Choose this button to print a Reagent
Load/Unload List and to replace the required reagents.
u
See
o
Reagent below alarm level o
Reagent empty
The button changes color to yellow to indicate a calibration or QC is recommended.
Choose this button to perform calibration and QC.
u
See
Choose this button to download parameters from the data manager.
The button changes color to indicate that parameters for applications, calibrators, controls, or special wash are available on the data manager.
o
Updated or new information is available for download.
o
Important information is required by the instrument.
The Sample Tracking button is used to search for samples on the instrument. Sample tracking is possible during operation as long as the loading tray has not been removed from the unloading area and no new run has been started.
Work Flow Guide u
For detailed information about these functions and the meaning of the colors used, please refer to the Online Help of the Overview menu.
Pre-routine steps
NOTICE
We recommend performing the pre-routine steps for buttons that changed color to purple, yellow or red:
1.
Performing maintenance (p. 292) (now or before power off)
2. Clearing the database and/or back up data
3. Downloading parameters from data manager
4.
5.
Performing calibration and QC (p. 280)
A short description of the pre-routine steps is contained in table 12-3 (p. 276). Steps 3
and 4 are described in the following sections in detail.
Operation of the analyzer may slow down and become error-prone
The database for patient and QC results can contain up to 12 000 samples. If more than
9400 samples are contained, the Sample Data Clear button turns yellow. When 11 999 samples are reached, it turns red.
r It is strongly recommended to delete the contents of the database daily.
r Make sure that the results are transferred to the LIS or saved on external storage media before deleting the contents of the database.
Roche Diagnostics
Operator’s Manual · 4.2.1
277
12 Daily operation
Pre-routine operation cobas® 8000 modular analyzer series q Download parameters prior to preparation of reagents
If you download new parameters at the end of pre-routine operation, you may have to perform reagent preparation, calibration and QC again. Therefore, we recommend using the Parameter Download button prior to the Reagent Preparing button.
Preparing reagents
When the Reagent Preparing button changes color, a reagent needs to be replaced or loaded according to the daily needs. However, this function is available only if reagent alarm levels and mandatory tests are defined.
u
For information about reagent alarm levels and mandatory tests, please refer to the
Online Help. See Utility > System > Reagent Level and Utility > System Configuration
> Test Assignment .
Before starting analysis, check the remaining volumes of reagents, diluents and detergents. The Reagent Load/Unload List displays reagent packs and other consumables that need to be loaded or replaced on the instrument.
u
For an example of the Reagent Load/Unload List including explanations, please refer to the Online Help. See Global buttons and windows > Reagent Print window .
p To print a Reagent Load/Unload List
1 Choose Reagent Preparing on the Overview menu.
Roche Diagnostics
278
Figure 12-5 Reagent Preparing window
2
Choose Reagent Load/Unload List .
3
Choose Close .
4
Choose Print (global button).
5
Choose History and select the current Reagent Load/Unload List .
6
Remove and replace any required reagent now according to the Reagent
Load/Unload List and the procedures described for each module.
u
For information on loading reagents, see:
Replacing reagents (cobas ISE module) (p. 341)
Replacing reagent packs (cobas c 701 module) (p. 352)
Replacing reagent packs (cobas c 702 module) (p. 366)
Replacing reagent packs (cobas c 502 module) (p. 387)
Replacing reagent packs (cobas e 602 module) (p. 403).
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
12 Daily operation
Pre-routine operation
Incorrect results due to expired reagents r Results obtained using expired reagents are not reliable. Do not use reagents that are expired.
7 After loading reagent packs onto the c 701 and c 702 modules, perform a reagent registration. Choose Reagent > Setting > Reagent Registration .
Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
8 On the Setting submenu, check that the values of Available Tests , Type , Lot ID , and Exp. Date of the new reagent packs are appropriate.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
279
12 Daily operation
Pre-routine operation
Performing calibration and QC
cobas® 8000 modular analyzer series
It is necessary to calibrate all applications and measure quality control (QC) samples regularly to verify the stability of the entire system. Make sure calibration and QC have been completed successfully before you start routine operation.
The intervals of calibration and QC vary with each application. The instrument automatically recommends calibrations and QC measurements according to the set intervals. The Calib. and QC Select button turns yellow to indicate a calibration or
QC is recommended.
Calibration and QC workflow
The following flow chart shows the recommended workflow.
5HFRPPHQGHGFDOLEUDWLRQDQG4&ZRUNÁRZ
&KRRVH&DOLEDQG4&6HOHFWEXWWRQ
<HOORZEXWWRQLQGLFDWHVWKDWFDOLEUDWLRQRU4&DUH
UHFRPPHQGHG
&DOLEUDWLRQ
‡6HOHFW5HFRPPHQGHGEXWWRQ
‡3ULQW&DOLEUDWLRQ/RDG/LVW
4&
‡6HOHFW5RXWLQH4&EXWWRQ
‡6HOHFW6WDQG%\%RWWOH4&EXWWRQ
‡3ULQW4&/RDG/LVW
/RDGFDOLEUDWRUVDQGFRQWUROV
VHHSULQWHGOLVWV
6WDUWPHDVXUHPHQW
1R
9DOLGDWLRQ
‡&KRRVH0RQLWRUEXWWRQDQGFKHFNIRUGDWD
DODUPV
‡2Q4&¬!¬5XQ¬6WDWXVFKHFNLIDOO4&SRLQWV
DUHZLWKLQWKHDSSURSULDWH6'UDQJH
9DOLGDWLRQ
5HVXOWVRN"
<HV
&RQWLQXHZLWKURXWLQHRSHUDWLRQ
&KHFNIRUGDWDDODUPVDQGSHUIRUP
UHPHGLHV
Figure 12-6 Recommended calibration and QC workflow q Your laboratory might use calibration and QC workflows that may differ in some details from the recommended workflow shown in this section.
Roche Diagnostics
280 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Pre-routine operation u
For more detailed information on calibration and QC, see:
Calibration and QC steps
The entire calibration and QC process comprises the following steps:
1.
To request calibration and QC and to print load lists (p. 281)
2.
To load required calibrators and controls (p. 281)
3.
To measure calibrators and controls (p. 282)
4.
To validate calibration and QC results (p. 282)
u
For information on validating QC results, please refer to the data manager component
QC routine in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
p To request calibration and QC and to print load lists
1
Choose Calib. and QC Select in the Work Flow Guide area.
CAUTION
Figure 12-7 Calib. and QC Select window
2 From the Calibration area, choose Recommended and choose Load List Print .
3 From the QC area, choose Routine QC and Stand By Bottle QC .
4 Choose Load List Print .
The Calibrator Load List and the QC Load List display all calibrators and controls that are needed to perform the requested measurements.
5 Choose Close .
6 To display or print the load lists, choose Print (global button) > History .
s p To load required calibrators and controls
Injury due to contact with rack loading mechanism r Only load or unload racks when the green status LEDs at the rack loading area are on.
Roche Diagnostics
Operator’s Manual · 4.2.1
281
12 Daily operation
Pre-routine operation cobas® 8000 modular analyzer series
CAUTION
CAUTION
Incorrect results due to expired calibrators or controls
Results obtained using expired calibrators or controls are not reliable.
r Do not use calibrators or controls that are expired.
r Do not mix-up calibrator containers or control containers.
r Do not use target values for calibrators or controls from a different lot.
1
Using the load lists as a guide, prepare all required calibrators and controls according to the manufacturer's instructions. Check that no bubbles or foam are visible on the liquid surface.
2
Load black calibrator and white control racks onto a tray and place it into the loading area.
When you perform QC after calibration, QC racks must follow directly after calibrator racks.
Calibration or QC failures r If you need to manually assign a calibrator or QC container to a rack—for example, due to an unreadable barcode—do not place any samples with barcodes on the same rack. If manually assigned containers and barcoded containers are on the same rack, the requested calibrations are not performed and the requests are deleted. An error message is generated.
r Do not use micro cups for calibrators and controls.
r Regularly perform QC measurements during operation to continuously monitor the instrument performance.
s p To measure calibrators and controls
1 After all calibrator and control racks are loaded, choose Overview .
2 Make sure the incubator temperatures on the modules are within 37 °C ± 0.1 °C.
Wait until the temperatures are reached to ensure measurement accuracy.
3 Choose Start (global button).
4 Choose Start to start the calibration and control run.
s p To validate calibration and QC results q It is important to verify that calibrations and QC results are valid before measuring routine samples. Calibration results can be validated on the instrument.
QC results are displayed on the Workplace > Data Review submenu and are validated on the data manager. The validated results are transferred back and displayed on the QC
> Run Status submenu.
We recommend the following steps to validate calibration and QC results:
1 After measurement is completed, check the Overview menu. If a calibration fails or is newly recommended, the Calib. and QC Select button turns yellow again.
2 Choose Monitor (global button) to review the calibration results in the Monitor window. Check for data alarms, which are indicated as short names with up to six characters (for example, Cal.E, SD.E, …).
Roche Diagnostics
282 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Pre-routine operation
3 On the QC > Run Status submenu, check if all QC points are within the appropriate SD range (no Today’s out of data points). If not, check the data manager for troubleshooting information.
4 If a calibration fails or a QC result falls out of the expected range, look up the meaning of each data alarm and perform the remedies described.
u
See
5 After taking the necessary remedies, repeat calibration and QC from the
Overview menu before you begin routine analysis.
Continue with
To request calibration and QC and to print load lists (p. 281).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
283
12 Daily operation
Routine operation
Routine operation
CAUTION
CAUTION cobas® 8000 modular analyzer series
Before continuing with routine operation, clear the Preventive Action check box on the Overview menu. Otherwise, the instrument will issue purple alarms in the course of routine operation.
Routine operation involves the following items:
1.
2.
Sampling Stop (S.Stop) status and Rack Reception Mode (p. 289)
3.
Before performing the following actions, observe these safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Incorrect results and interruption of analysis due to contaminated samples (p. 31)
r
Injury or damage to the instrument due to contact with rack transfer mechanism
r
Incorrect results due to sample mismatch in non-barcode mode (p. 230)
r
Interruption of operation due to interlock system (p. 230)
Injury due to contact with rack loading mechanism r Only load or unload racks when the green status LEDs at the rack loading area are on.
Incorrect results due to the use of micro cups on e 602 modules
When the tip of the sample probe touches the inner wall of a micro cup, this may result in improper sample aspiration.
r Do not use micro cups for samples to be processed on e 602 modules. q Sample preparation
When preparing samples, always ensure that the preanalytical requirements are fulfilled according to good laboratory practice and tube manufacturer recommendations.
Processing samples
In this section, the workflow is described for an instrument that operates in connection with an LIS and is set to process barcoded samples. The test selection is usually downloaded from the LIS (host) via the data manager.
u
For information on other configurations, see chapter 13 Workplace (p. 295).
Roche Diagnostics
284 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Routine operation
Processing routine samples
If you need a list of samples to be loaded (batch mode), print a Requisition List .
p To load routine samples
1 Prepare gray routine sample racks with rack numbers according to the sample types (such as Ser/Pl, Urine, CSF…).
2 Place samples into the racks.
Ensure sample barcodes are facing the open slot in the rack so the barcode reader can scan them. (If you use the automatic tube rotation and MPA racks, the orientation of the tubes is not necessary.)
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A Green status LEDs on – samples can be loaded or removed
Figure 12-8 Loading routine samples
3 Before opening the cover of the rack loading area, check the green status LEDs (
are on.
4 Load rack trays with routine sample racks into the rack loading area. Ensure the
correct orientation of the racks (see figure 12-8).
u
For information on sample containers and their correct placement in racks, see
Sample containers, racks and trays (p. 89).
s p To start processing
1 Ensure that all test selections have been made on the LIS and routine samples have been loaded.
u
For test selections from the instrument software, see:
285
12 Daily operation
Routine operation
2 Choose Start (global button).
cobas® 8000 modular analyzer series
Figure 12-9 Start window (barcode mode) q Ensure that all covers are closed. Operation would not start if an interlock cover is open.
3 Verify the settings on the Start window and choose Start .
The instrument performs a preparation routine including a reagent registration.
During Preparation status, water as well as any air which may have become trapped are discharged at the rinse stations.
4 While preparation is performed on the e 602 module, visually check that water is dispensed from the tip of the sample probe and the reagent probe in a straight flow. If water is not dispensed in a straight flow, call technical support.
Then the status changes to Operation and the instrument begins to process samples.
u
For more information on setting the start conditions, see:
Start Up Pipe function (p. 601)
s
Roche Diagnostics
286 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Routine operation
Processing STAT samples
NOTICE
Samples loaded from the STAT (emergency) port are processed with higher priority than those from the rack loading area.
Instrument damage when a rack is inserted wrongly
The instrument normally issues an alarm if a rack was inserted wrongly in the STAT port.
However, under certain circumstances a wrong rack direction cannot be detected, which may possibly lead to instrument damage.
r Ensure the correct orientation of the rack when loading it into the STAT port.
q o From the STAT port, routine and STAT racks are processed with a higher priority than patient sample racks residing in the rack loading area.
o If a barcode read error has occurred and the rack position has been manually assigned, be sure not to place another barcoded sample in that position. p To process a STAT sample
1
Ensure that all test selections have been made on the LIS.
u
For test selections from the instrument software, see:
2
Place samples into the red STAT rack.
Ensure sample barcodes are facing the open slot in the rack so the barcode reader can scan them. (This is not required if you use the tube rotation function .)
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 12-10 Loading racks into the STAT port
3 Load the rack into the STAT port. Ensure the correct orientation of the rack.
4 Depending on the status of the instrument samples are processed as follows: o
If the instrument is in Operation mode, samples are processed without any further action.
or, o If the instrument is in any other status, choose Start on the Start window to initiate the run.
s
287
12 Daily operation
Routine operation cobas® 8000 modular analyzer series
Processing additional samples
Additional samples can be loaded onto the instrument at any time.
q Processing automatic reruns
Reruns are usually processed automatically depending on your configuration.
u
For more information on automatic and manual reruns, see:
Performing manual reruns (p. 308)
p To process additional samples
1
Ensure that all test selections have been made on the LIS.
q Test selections for additional samples are downloaded from the LIS in real-time.
u
For test selections from the instrument software, see Requesting a test manually
2 Place samples into the racks.
Ensure sample barcodes are facing the open slot in the rack so the barcode reader can scan them. (This is not required if you use the tube rotation function .)
3 Ensure the green status LEDs at the rack loading area are on.
4 Load additional patient samples either at the STAT port or into the rack loading area.
You may also load calibrators and controls if calibration or QC are requested.
5 Depending on the status of the instrument samples are processed as follows: o
If the instrument is in Operation mode, samples are processed without any further action.
or, o
If the instrument is in any other status, choose Start on the Start window to initiate the run.
s
Roche Diagnostics
288 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Routine operation
Sampling Stop (S.Stop) status and Rack Reception Mode
CAUTION
After all test requests are completed, sampling stops. The instrument remains in Rack
Reception Mode (RRM) if this was activated on the Start window. Thereafter, finalization for the e 602 module is performed and then the instrument goes into
Standby.
The duration of the Rack Reception Mode – from start of analysis to Standby – is displayed on the Start window. The Rack Reception Mode can be set to up to
24 hours under Utility > System > Rack Reception .
Interrupt of operation
Pressing the Stop (global button) would stop operation on all modules. Results currently being processed would be lost! All pipetted samples would be lost and must be reloaded.
Furthermore, reaction cells would not be washed and, on e 602 modules, finalization would not be performed.
r To terminate Rack Reception Mode, choose the Change button in the Start window and clear the corresponding check box. Then the instrument will go into Standby and you may start performing maintenance, for example.
r Never choose Stop (global button) to terminate Rack Reception Mode.
Checking results
As results are generated on the instrument, they are saved in the database located on the internal hard disk of the control unit. The instrument automatically sends the results to the data manager at fixed intervals.
The results can be reviewed on the instrument, but the validation of the results must be performed on the data manager.
u
For more information, see:
Performing manual reruns (p. 308)
u
For information on validating QC results, please refer to the data manager component
QC routine in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
p To review results on the instrument
1 Choose Monitor (global button) or Workplace > Data Review to review the results.
2 Check for data alarms, which are indicated as short names with up to six characters (for example, Cal.E, Reag.S, >Test, …).
3 If a test result is flagged with a data alarm, look up the alarm and perform the remedies described.
u
See
o
Flagged tests will be measured again for most of the data alarms if the automatic rerun function is activated.
u
o
Otherwise, perform a manual rerun.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
289
12 Daily operation
Routine operation
Tracking samples cobas® 8000 modular analyzer series
The Sample Tracking window provides an overview of the samples in the unloading area. The search function allows you to search for samples which are already in the rack unloading area.
q The location of a sample is indicated only as long as the sample tray has not been removed from the unloading area.
p To search for a specific sample
1
Choose Sample Tracking on the Overview menu.
Roche Diagnostics
290
Figure 12-11 Sample Tracking window
2
In the Sample Search area, select the STAT or Routine option depending on the sample being searched for.
3
Choose the sample type from the S. Type list box.
4
Select the required search criterion.
5
Enter the data you are searching for in the corresponding text field.
6
Choose Search .
If the sample is in the rack unloading area, the sample is highlighted in the Rack
Information area and the rack is highlighted in the Rack Monitor area.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Routine operation
Displaying and printing results
The instrument software provides two ways for displaying and printing sample results.
o
The Monitor window continuously displays all patient, calibration, and QC results.
o
The Data Review submenu allows selection of single or multiple samples (only patient and QC results are displayed). The selected results can be viewed and printed in the Print window ( Result List report).
u
For a detailed description of the Result List , please refer to the Online Help of the Result
List report.
p To view recent results
1
Choose Monitor (global button).
2
Use the scrollbar or the mouse wheel to scroll the results.
s p To print selected results
1 Choose Workplace > Data Review .
2 Select single or multiple samples to be printed from the list on the left.
3 Choose Print (global button).
4 Choose Workplace > Result List .
5 Select the desired options in the center of the screen.
6 Choose Preview . The icon on the Print button starts flashing.
7 When the icon has stopped flashing, choose History .
8 Choose Print Out .
s
Roche Diagnostics
Operator’s Manual · 4.2.1
291
12 Daily operation
Maintenance and power off
Maintenance and power off
cobas® 8000 modular analyzer series
This section describes the tasks to be performed at the end of shift:
1.
Performing maintenance (p. 292)
2.
Powering off the instrument (p. 293)
3.
Instrument inspection (p. 294)
Performing maintenance
At the end of routine operation, it is important that all required maintenance is performed. In addition to the routine daily maintenance, this could also include other scheduled maintenance – for example, weekly and monthly maintenance.
Flexibility Maintenance may be performed at different time points during a shift. For example, when performing maintenance actions (
) you can choose between three possibilities: o
Maintenance actions (
) may be performed either before powering off , or o during pre-routine operation, or o in case of idle times on a single module, as part of background maintenance during routine operation.
The following graph shows possibilities for performing maintenance.
6WDUWXSDQGGDLO\
FKHFNV
3UHURXWLQH
RSHUDWLRQ
5RXWLQHRSHUDWLRQ
0DLQWHQDQFHDQG
SRZHURII
$ % &
0DLQWHQDQFHDFWLRQUHFRPPHQGHGSRLQWLQWLPH
& & ' $
0DLQWHQDQFHDFWLRQDOWHUQDWLYHSRLQWLQWLPH
0DLQWHQDQFHSLSHDVHWRIVRIWZDUHFRQWUROOHGPDLQWHQDQFHLWHPVDXWRPDWLFDOO\SHUIRUPHGE\WKH
LQVWUXPHQW
A Instrument inspection
B Power Up pipe (if configured), requires visual checks
C Maintenance actions, not included in a pipe. Daily and other intervals.
D Power Off pipe (if configured)
Figure 12-12 Overview of maintenance during a shift
Roche Diagnostics
292 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 12 Daily operation
Maintenance and power off
Powering off the instrument
After routine operation is finished and all required maintenance has been performed, the instrument can be powered off. Reagent compartments continue to be kept at a constant temperature of 5 to 15 °C even when the instrument is powered off.
q Checks before powering off the instrument
If you use the Power Up Pipe function to be performed automatically at power up of the system, always check the following before powering off the instrument: o Make sure the Preventive Action check box on the Overview menu is selected.
o Check the remaining amount of the reagents required by the Power Up pipe.
u
See: Power Up Pipe function (p. 599).
q Extended power off (more than overnight)
If you power off e 602 modules for 1–2 days or longer (e.g., a weekend), follow the
procedures described in chapter 24 Maintenance of cobas e 602 module (p. 761).
u
See: Extended power OFF and ON procedures (p. 801).
q We recommend powering off the instrument at least once a week. Start it up again afterwards.
Always restart the instrument after the data manager was restarted.
q If the time switch has been programmed, the instrument will start up automatically at the set time.
u
For information on automatic start-up by timer, see
Setting the date and time (p. 487).
p To power off the instrument
1 Press the orange Operation Power OFF button, located at the front of the core unit.
2 Turn off the water supply if the instrument will be unused for more than 8 hours.
3 Perform the instrument inspection, either now or before the next power-on.
Especially if the instrument has been set for automatic start-up, ensure the instrument inspection is done at the end of a working session.
u
See
Instrument inspection (p. 294)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
293
12 Daily operation
Maintenance and power off
Instrument inspection
cobas® 8000 modular analyzer series
Perform the instrument inspection either before start-up or after power off . Especially if the instrument has been set for automatic start-up, ensure the inspection is done at the end of the previous working session.
If any problems arise, refer to the module-specific maintenance and troubleshooting chapters.
Printer
Core
All modules
ISE c 701 / c 702 c 502 e 602
Table 12-4
Check that:
There is sufficient paper in the printer.
The main water supply is turned on before operation.
The container for highly concentrated waste is clean and empty.
There are no racks in the rack loading/unloading area, module sample buffer, or conveyors.
All surfaces are clean and clear of loose articles.
No tubing is pinched or bent.
Syringes are not leaking.
All connections and fittings of tubes and containers are connected properly and are not leaking.
Auxiliary reagents for the Daily pipe (started by the Power Up Pipe function) are loaded.
All covers and doors of the modules are closed and locked.
Inside the ISE compartments: The ISE sipper tubing and pinch valve tubing are not leaking and the electrode wires are connected properly.
The cell covers are free of contamination. If necessary, clean the cell covers using a gauze pad moistened with isopropyl alcohol or ethanol.
All reagent packs are removed from the reagent pack disposal.
Check that the amount of ProbeWash solution (near the reagent probe) is sufficient.
Instrument inspection
Roche Diagnostics
294 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Workplace
Orders and results
13 Workplace
13
This chapter describes common tasks associated with the Workplace menu. For a detailed description of the Workplace menu, please refer to the Online Help.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
13
Viewing the status of controls on the Test Review window................................... 319
295
13 Workplace
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
296 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Introduction
Introduction
The cobas 8000 modular analyzer series typically operates in connection with an LIS and is set to process samples in barcode mode .
Barcode and non-barcode mode
We strongly recommend operating the instrument in barcode mode and using barcodes for samples, calibrators, and controls.
When operating in non-barcode mode, you must ensure that the test results are assigned to the correct patient samples throughout the entire processing workflow.
There are two possibilities for working without sample barcodes: o
Only a few non-barcoded samples are processed. The instrument and the data manager are set to barcode mode .
o
The instrument and the data manager are set to non-barcode mode .
Non-barcoded samples in barcode mode
Even if the barcode mode is activated, it is possible to process single samples without barcodes. In this case, use the Barcode Read Error window to enter a test selection for these samples ( Workplace > Test Selection ). u
See To enter an unreadable sample barcode (p. 307).
q Non-barcoded samples when operating with an MPA
The barcode mode is also used if non-barcoded samples were aliquoted on an MPA. In this case, the cobas 8000 modular analyzer series receives the sample ID and the rack and position number together with the test request.
Calibrators and controls may also be used without barcodes even if the barcode mode is activated. In this case the rack number and position number must be assigned.
Non-barcode mode
(sequence mode)
In the non-barcode mode, the samples must be assigned to test requests using worklists. A worklist is a sequential numbering of samples. Worklists are either generated manually or by a host. The samples must be placed on racks according to their sequence number.
For routine samples, only the Sequence No.
is used to identify the sample. Even if a sample ID was assigned by the LIS, the instrument does not use it for identification.
STAT samples are identified directly by the fields Rack No.
and Pos.
(without a worklist).
CAUTION
Incorrect results due to sample mismatch (without barcodes) r When operating without barcodes, make sure to load the samples according to the
Requisition List provided by the instrument.
r Avoid empty positions within the racks. Do not place unregistered samples in any empty rack position.
r When manually assigning positions, ensure the position is not already assigned.
u
For more information about working with the non-barcode mode in the data manager, please refer to the chapter Routine tasks in the Operator’s Manual of the cobas 8000 data manager.
Roche Diagnostics
Operator’s Manual · 4.2.1
297
13 Workplace
Introduction cobas® 8000 modular analyzer series
Switching from barcode mode to non-barcode mode or vice versa
The sample ID (barcode number) is used to identify each sample in the sample databases of the instrument and the data manager. Therefore, you cannot easily switch between the barcode and the non-barcode mode.
q Changing the barcode mode setting
All samples must be deleted from the Data Review submenu, before you can change the barcode mode settings under Utility > System > Barcode Settings .
Furthermore, all samples must be deleted from the data manager to prevent the risk of duplicate sample IDs in the database.
Please also consider clearing the database of the LIS.
Workflows for sample processing
Test selections (or orders) are usually downloaded from the LIS (host) via the data manager. Test selections can also be entered manually in the data manager or the instrument software, for example, when you are operating without LIS connection.
Samples can be processed in two different ways (see figure 13-1).
o
Test Selection Real Time Inquiry mode: Usually the instrument reads the barcodes of the loaded samples in real time and requests the corresponding test selection from the LIS via the data manager.
o
Test Selection Batch Request mode: In this case, the LIS sends the test selection via the data manager prior to loading of samples. The Requisition List provides information on the requested samples.
7HVW6HOHFWLRQ5HDO7LPH
,QTXLU\PRGH
7HVW6HOHFWLRQ%DWFK5HTXHVW
PRGH
/RDGVDPSOHV
/,6VHQGVWHVWVHOHFWLRQYLD
GDWD¬PDQDJHUWRLQVWUXPHQW
6WDUWPHDVXUHPHQW
/RDGVDPSOHV
VHH5HTXLVLWLRQ/LVW
,QVWUXPHQWUHTXHVWVWHVWVHOHFWLRQ
IURP/,6YLDGDWD¬PDQDJHU
6WDUWPHDVXUHPHQW
Figure 13-1 Possible sample processing workflows
To activate the Test Selection Batch Request mode, disable the Test Selection
Inquire Always check box on Utility > System > Data Manager Settings > Test
Selection Inquiry Settings (administrator level access required).
Roche Diagnostics
298 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Introduction
Sample containers and racks
For the cobas 8000 system, different rack types and sample containers are available.
A B C D
A Sample tube
B Micro cup
C Standard cup
D False bottom tube
Figure 13-2 Sample tubes and cups u
For more information about containers, see:
Container specifications (p. 213)
Which container for which application?
Correct alignment of sample tubes on a rack (p. 95)
u
For more information about racks, see:
Rack loading and unloading (p. 80)
Rack classes and colors of standard racks (p. 93)
Roche Diagnostics
Operator’s Manual · 4.2.1
299
13 Workplace
Menu summary
Menu summary
cobas® 8000 modular analyzer series
Submenu
Workplace > Test Selection submenu
The following sections describe how orders can be entered and results are displayed within the cobas 8000 instrument software.
Function
The Workplace > Test Selection submenu is used to enter test selections and sample information for a sample.
The fields available for sample identification vary, depending on whether the instrument is operating in barcode mode or not.
u
See
Test Selection submenu (p. 301).
Workplace > Data Review submenu
Workplace > Calib. Review submenu
The Workplace > Data Review submenu is used to perform the following: o
To view routine, STAT and control results o
To edit sample information o
To send data to the data manager o
To delete data individually or in batches o
To back up data o
To edit data u
See
The Workplace > Calib. Review submenu is used to perform the following: o
To review the status of calibrators o
To review the status of calibration results u
See
Calib. Review submenu (p. 323).
Table 13-1
Roche Diagnostics
300
Menu overview
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Test Selection submenu
To display this submenu, choose Workplace > Test Selection .
13 Workplace
Test Selection submenu
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 13-3 Test Selection submenu
Use the Test Selection submenu to enter test selections and information for a sample.
After entries have been made on the Test Selection submenu, choose the Save button to save the test selections.
Fields
Sample ID
Sequence No.
Rack No. / Pos.
Table 13-2
Barcode mode
Routine l
–
–
STAT l
–
–
Non-barcode mode
Routine l l
–
STAT l
– l
Test Selection submenu - fields available for sample identification u
For information about the test selection matrix, see
Test selection matrix (p. 302)
u
For information on special operation procedures, see:
Requesting a test manually (p. 304)
Entering unreadable sample barcodes (p. 307)
Performing manual reruns (p. 308)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
301
13 Workplace
Test Selection submenu cobas® 8000 modular analyzer series
S. Type Use this list box to select the sample type: o
Serum/Pl: Use this sample type for serum or plasma.
o
Urine: Use this sample type for urine samples.
o
CSF: Use this sample type for cerebrospinal fluids.
o
Suprnt: Use this sample type for supernatants or for whole blood on c 502 modules.
o
Others: Use this sample type for other body fluids than mentioned above. If you select the sample type Others, the instrument always takes the application data of
Serum/Pl set under Utility > Application . The application must be available for
Serum/Pl.
q For each test, only four sample types can be defined.
Test selection matrix
The keys in the test selection matrix display different colors and markings depending on status or programming.
Colors The test keys display different colors to indicate the status of the test for the sample
ID in the Sample ID text box. The following colors are available:
This test has been selected.
This test has been performed and a result is available. The test may be reordered again.
Markings One test or profile can be assigned to each key. The test keys display special markings depending on the test status or programming. The different markings and their meanings are outlined below:
Blank test key indicates no test is assigned.
Test key with a test or profile name and no masking indicators. The test can be requested; additional settings are not required. The reagent is on board and registered.
Mask: The test can be requested but is not measured because the module or test is masked ( Start > Masking ). The test will be measured after masking is manually removed.
o
Module Masked : Module is in Standby status to allow performing maintenance or loading reagents.
o
Patient Masked : Prevents patient samples from running but the operator can still calibrate and perform QC.
o
Test Masked : Prevents the processing of calibration, QC, and patient samples. The test is turned off.
Roche Diagnostics
302 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Test Selection submenu
Reagent mask (no reagent available)
Test is automatically masked by the system. The test reagent is either empty or not present on the instrument. The test can be requested; however, the test is performed only if a new reagent is placed on the instrument.
For e 602 modules: The test is also masked if a pretreatment or diluent required by this test is empty or not present on the instrument.
The red bar is not displayed on the test key (test is not masked) in the following cases: o o
The corresponding reagent is available on another module.
Another diluent or a detergent is empty or missing (for example
SmpCln 1, CellCln 1, Ecotergent or ProbeWash).
Calibration mask (calibration failed)
Test is automatically masked by the system if no valid calibration is available and the test requires a calibration.
The purple bar is not displayed on the test key in the following cases: o
Calibration auto masking setting for the individual test is not selected on
Utility > Application > Calib.
o
Calibration auto masking setting for the instrument is not selected on
Utility > System > Calib. and QC Settings .
o
The test has a valid calibration on another module.
o
Increase
Test will be run with the increased sample concentration set on Utility
> Application > Analyze.
o
Decrease
Test will be run with the decreased sample concentration set on Utility
> Application > Analyze .
o o
Dilution Ratio
Test will be run with a dilution. The number after the triangle indicates the ratio of the dilution (for example, 3 is 1:3).
For e 602: Test will be run with the recommended dilution ratio set on
Utility > Application > Analyze.
o
Profile
A brown bar on the key indicates a profile has been assigned to the key.
When selected, all tests assigned to that profile are displayed with a blue border.
q If the reagent for a test is not on board, the corresponding test key is marked with the reagent mask symbol.
u
For detailed information on the various masking functions, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
303
13 Workplace
Test Selection submenu
Requesting a test manually
cobas® 8000 modular analyzer series
Tests may be manually selected for routine and STAT samples. q Manual selections remain unchanged
All manual selections such as sample type and dilution ratio remain selected until they are manually changed.
q o Not all dilution ratios are available for each test.
o If you choose a dilution ratio in the Sample Volume / Dilution box, this will override the pre-programmed dilution ratio indicated on Utility > Application > Analyze .
p To request a routine sample (barcode or non-barcode mode)
1
Choose Workplace > Test Selection .
2
Select the sample type from the S. Type list box.
3
Select the Routine option from the Sample area.
4
In barcode mode: Type the sample number into the Sample ID text box and press the Enter key.
In non-barcode mode: Type the sequence number for the sample into the
Sequence No.
text box. Enter the Sample ID additionally if desired.
5
Select the Pre-dilution check box if the sample has already been diluted manually.
6
Select the sample container type in the Sample Cup box.
7
Select the necessary dilution in the Sample Volume / Dilution box, if any, for the sample.
8
Select the test, combination of tests or test profiles for the sample in the test key matrix.
Selected tests and profile keys are displayed with a blue border.
9
Choose Save to save the test selection.
s
Roche Diagnostics
304 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
13 Workplace
Test Selection submenu p To request a STAT sample (barcode or non-barcode mode)
Incorrect results due to sample mismatch (non-barcode mode)
When operating in non-barcode mode: r Do not insert any gray rack into the STAT port because the predefined sequence of samples would get disrupted by the STAT port inserted routine rack.
r Make sure to load the samples according to the Requisition List as provided by the instrument. Avoid empty positions within the racks. Do not place nonregistered samples in any empty rack position.
q
1
Choose Workplace > Test Selection
2
Select the sample type from the S. Type list box.
3
Select the STAT option from the Sample area.
o
In non-barcode mode, go to step 4
.
o
In barcode mode, go to step
4 Type the rack number of the sample in the Rack No.
text box and press the Enter key.
5 Type the position number of the sample in the Pos.
text box and press the Enter key.
6 Type the sample ID of the sample in the Sample ID text box and press the Enter key.
7 Select the Pre-dilution check box if the sample has already been diluted manually.
8 Select the sample container type in the Sample Cup box.
Micro cups are not to be used on the e 602.
9 Select the necessary dilution in the Sample Volume / Dilution box, if any, for the sample.
10 Select the test, combination of tests, or test profiles for the sample in the test key matrix.
Selected tests and profile keys are displayed with a blue border.
11 Choose Save to save the test selection.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
305
13 Workplace
Test Selection submenu cobas® 8000 modular analyzer series p To check and correct registered tests and to start analysis q After all test selections have been registered, we recommend checking the programming by printing a Requisition List . When operating in non-barcode mode, it is important to load samples in their assigned positions.
1 Print the Requisition List or check the registered tests on the submenu as described below.
2 In the Test Selection submenu: o
Type the sample ID number of the first sample in the Sample ID text box. or, o
In non-barcode mode, type the first sequence number in the Sequence No.
text box.
3
Check the sample programming: o
Choose Next to display the next sample without correction. or, o
Correct the selected tests and choose Save to save the corrected test selection.
4 Repeat the above procedure up to the last sample to be checked. o
In non-barcode mode, go to step 5
.
o
In barcode mode, go to step
5
Choose Start (global button).
6
Type the first sequence number from which analysis is to be started in the corresponding text box of the sample type in the Start window.
7
Start analysis.
s
Roche Diagnostics
306 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Test Selection submenu
Entering unreadable sample barcodes
CAUTION
The Barcode Read Error window is only available in barcode mode.
Incorrect results due to sample mismatch r When registering samples with unreadable barcodes, make sure to select the correct sample. Check the rack and position number of the affected sample.
q The non-read position assignments are deleted once the rack(s) to which samples are assigned are scanned by the rack ID reader. Therefore, once the rack is read it can be re-used for different samples. If it is necessary to run these samples again, the position assignment must be re-entered.
p To enter an unreadable sample barcode
1
Choose Workplace > Test Selection .
2
Choose Barcode Read Error .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 13-4 Barcode Read Error window
3
Select the sample type ( STAT or Routine ) in the Sample area.
4
Select the sample material from the Sample Type list box.
5
Type the rack number and position in the Rack No. - Pos.
text boxes.
6
Type the sample ID of the sample in the Sample ID text box.
7
Choose Add . The sample type, rack number and position, and sample ID are displayed.
8
for any further samples with a barcode read error.
9
Choose OK .
s
307
13 Workplace
Test Selection submenu
Performing manual reruns
cobas® 8000 modular analyzer series
Samples can be manually selected for rerun if a single test result is flagged with a data alarm. Even if a result is not flagged with a data alarm, it may sometimes be desirable to verify a result by a rerun. Samples which are manually scheduled for rerun must be placed onto the instrument again.
This manual procedure is necessary if the Automatic Rerun setting in the Start window is disabled.
u
For general information about reruns, see:
Manual reruns in barcode mode
You may request a manual rerun for routine and for STAT samples like a normal test request using the Test Selection submenu.
u
See Requesting a test manually (p. 304)
q The positions of barcoded samples can be changed for rerun. New samples can be measured at the same time. You can change the sample volume or request a dilution for rerun.
Manual reruns in non-barcode mode
Manual reruns in non-barcode mode can be performed for routine samples.
Therefore you may either request a manual rerun like a normal test request using the
Test Selection submenu or you may request a manual rerun using the Rerun Rack
Assignment window.
u
For more information, see:
Requesting a test manually (p. 304)
Assigning or deleting a rerun rack (p. 309).
q You can change the sample volume or request a dilution for rerun.
For STAT samples, a manual rerun cannot be requested in non-barcode mode.
Roche Diagnostics
308 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Test Selection submenu
Assigning or deleting a rerun rack
Samples requested for a rerun are only manually assigned to a rack when the instrument is in non-barcode mode.
CAUTION
Incorrect results due to sample mismatch
If unloaded racks are reloaded in non-barcode mode, sample mismatch may occur.
r Never reload an unloaded rack when working in non-barcode mode. In non-barcode mode, pink racks must be used for reruns.
p To assign a rerun rack
1 Choose Workplace > Test Selection .
2 Type the sample ID of the sample in the Sample ID text box.
q If any changes have to be made to the test selection and/or sample dilution, they can be done at this time.
3 Choose Rerun Rack Assignment to display the Rerun Rack Assignment window.
4 Check that the details displayed on the Rerun Rack Assignment window are correct.
5 Type the rack number and position of the pink rerun rack in the Rack No.-Pos. text boxes.
6 Choose OK .
s p To delete a rerun rack q To reassign a rerun, the old assignment must be first deleted, and then the new rack ID and position entered.
1
Select the sample to reassign from Workplace > Test Selection .
2
Choose Rerun Rack Assignment .
3
Choose Delete to delete the rack assignment.
4
Choose Cancel to close the Rerun Rack Assignment window without deleting.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
309
13 Workplace
Data Review submenu
Data Review submenu
cobas® 8000 modular analyzer series
To display this submenu, choose Workplace > Data Review .
Roche Diagnostics
310
Figure 13-5 Data Review submenu (barcode mode)
Use this submenu to perform tasks related to reviewing and editing routine and
STAT results. Control results can also be viewed here. Additionally, use the Test
Review window to view the details of results and the Reaction Monitor window to view absorbances and reaction points.
Other tasks that can be performed from this submenu include editing sample information, sending data to the data manager, editing, searching, filtering, and deleting data individually or in batches, and backing up data.
u
For information on special operation procedures, see:
Editing or deleting sample results (p. 316)
Archiving patient data (p. 321)
Displaying archived patient data (p. 322)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Data Review submenu
Sample selection list
This list on the left side of the screen displays the samples registered by the system. Its content varies depending on whether barcode, or non-barcode mode is selected on
Utility > System > Barcode Settings .
DM This column displays whether results have been sent to the data manager or not.
No symbol
H (Sent to the data manager)
Results have not been sent to the data manager yet.
Results have been sent to the data manager.
C. E.
This column displays whether a special wash of the sample probe has been performed before pipetting of the sample (C.E. = carryover evasion).
No symbol
# b
Sample has not been pipetted yet.
OR: Sample was pipetted only on e 602
Sample has been pipetted on ISE or c module.
Note that additional measurements on e 602 modules might be affected by carryover (see following note).
A special wash on the sample probe has been performed before the sample was pipetted on ISE and / or c module
( c 701 / c 702 / c 502).
q Possible sample carryover when measuring high-priority immunoassays (HPI)
If HPI are requested for a sample, this sample is pipetted on the e 602 module prior to pipetting on clinchem modules.
If a sample has already been processed on a c module, a #-flag is displayed on the Data
Review submenu. This indicates the risk of potential carryover if sample from this sample container is used for additional or rerun HPI requests. o If a #-flag is displayed, always use newly aliquoted samples to perform manual reruns of high-priority immunoassays.
o If a sample has already been processed on a clinchem module and the sample is still onboard, and if a HPI has been sent as a reflex test, the HPI will be masked and not performed because of possible sample contamination.
u
For more information about special washes, see:
Programming a special wash (photometric modules) (p. 565)
Programming a special wash (cobas e 602 module) (p. 570)
St.
This column displays the sample status codes.
No character (Complete)
O (Ordered)
P (Processing)
I (Incomplete)
Sample was successfully processed. All test results are available without a data alarm.
Sample was requested or registered but not yet pipetted; or there is an open order for the sample.
Reasons for open orders (examples): All tests requested were masked, or an automatic rerun was requested because of a data alarm.
Sample is being processed.
A data alarm occurred on processing the sample, or one or more tests were masked.
Roche Diagnostics
Operator’s Manual · 4.2.1
Rack No. - Pos.
This column displays the rack number and sample position within the rack for the current sample.
311
13 Workplace
Data Review submenu
Test results list
cobas® 8000 modular analyzer series
This list on the right side of the screen displays the results of the tests performed on the sample currently selected in the left list.
C. E.
This column displays whether the special wash specified has been performed before pipetting.
#
Special wash required for this test has not been performed.
Dil.
In this column a symbol for the sample volume to be used is displayed. The sample volumes are defined on Utility > Application > Analyze . Application-specific dilutions are performed automatically by the system.
This symbol indicates a test to be run with normal sample volume.
This symbol indicates a test is to be run with an increased sample concentration. This applies to photometric assays only.
This symbol indicates a test is to be run with a decreased sample concentration. This applies to photometric assays and ISE tests only. For ISE tests, only urine samples can be run with decreased volume.
This symbol indicates a test is to be run with a diluted sample. The number displays the dilution ratio selected in the Workplace > Test Selection submenu.
The symbols for the dilution are displayed on Workplace > Data Review if the Print
Dilution Ratio check box is selected on Utility > System > Print Settings .
q o As soon as a result is available, it is displayed in this test result list. If serum index checks are requested, all test results appear when the results of the serum index checks are available.
o If a test has already run twice and a third request is made, the result of the second run is replaced by the result of the third run.
o All results are displayed individually on Workplace > Data Review > Test Review
> All Results .
Roche Diagnostics
312 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Data Review submenu
Searching for a sample in the database
Use this function to search for a sample in the database. Search criteria and options, such as sequence number and sample ID, are defined using this window.
p To display the Search Sample window
1
Choose Workplace > Data Review .
2
Choose the Search button to display the Search Sample window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 13-6 Search Sample window, left: non-barcode mode, right: barcode mode
The Search Sample window is an overlay on the right-hand side of the Data
Review submenu. This allows you to view both the window and the search results at the same time.
3 To search for a sample, perform one of the following procedures: o
To search for a sample by sample ID (p. 313)
o
To search for a sample by comment (p. 314)
s p To search for a sample by sample ID
1
Select the Sample ID option in the Find area.
2
In the list below, enter the sample ID or a part of the sample ID to be searched for.
3
Select the Match Case check box to specify capitalized or non-capitalized letters.
4
Choose the Down button to search the sample selection list of the Data Review submenu down from current selected sample.
Or: Choose the Up button to search the sample selection list of the Data Review submenu up from current selected sample.
The searched sample is highlighted in gray in the sample selection list.
5
Repeat step
4 to search for further samples with the same part of the sample ID.
s
313
13 Workplace
Data Review submenu cobas® 8000 modular analyzer series p To search for a sample by comment
1 Select the Comment-001 option in the Find area. q The title of the comment is defined on Utility > System > Comment Titles .
2 In the list below, enter the comment or a part of the comment to be searched for.
3 Select the check box Match Case to specify capitalized or non-capitalized letters.
4 Choose the Down button to search the sample selection list of the Data Review submenu down from current selected sample.
Or: Choose the Up button to search the sample selection list of the Data Review submenu up from current selected sample.
In the sample selection list, the searched sample is highlighted in gray. The comment of this sample is displayed in the Comment-001 area.
5 Repeat step
4 to search for further samples with the same part of the comment.
s
Roche Diagnostics
314 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Filtering data
13 Workplace
Data Review submenu
Information that is displayed in the sample selection list can be filtered by criteria defined on Workplace > Data Review > Filter . Select the ON or OFF options in the
Filter area to toggle the filter on or off.
p To define filter criteria and filter data
1
Choose Workplace > Data Review .
2
Choose Filter button to display the Filter window.
Figure 13-7 Filter window
3
Select the option you want to display in the sample selection list.
u
For more information about the different options, refer to Online Help .
4
Choose OK .
5
On the Data Review submenu, select ON in the Filter area.
The filtered results are displayed in the sample selection list.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
315
13 Workplace
Data Review submenu
Editing or deleting sample results
cobas® 8000 modular analyzer series
Sample data displayed on the Data Review submenu can be edited or deleted if required. Use the following procedures to edit or delete sample data.
p To delete a sample
1
Choose Workplace > Data Review .
2
Select an individual sample, or a number of samples, to delete from the list on the left of the screen.
3
Choose Delete Record to delete the sample(s) selected after confirmation.
4
To delete all records, choose Delete All .
s p To select a result to be edited or deleted
1 Choose Workplace > Data Review .
2 Select a sample from the list on the left. The results, 1st and Rerun, of the tests performed on this sample are displayed in the list on the right.
3 Choose Test Review to display the Test Review window. This window displays more information on the test results.
Roche Diagnostics
316
Figure 13-8 s
Test Review window p To edit sample data
1
In the Result column, select the test result to be edited. The result is activated
(blue background) and highlighted white.
2
Enter the new result (the old result is overwritten). The Updated button turns yellow.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Data Review submenu
3 Choose Update to save the changes, or Cancel to reset the entry to the original value.
After confirmation, edited is displayed in the Alarm column and E in the St.
column.
s p To delete test results
1
Select the test result to be deleted.
2
Choose Delete Test to delete the test after confirmation.
s
Unloading sample racks
Use the following procedure to unload a sample rack during an analysis run. This function is useful if you want to check a routine, rerun, or STAT sample visually for some reason. Calibrator and control racks cannot be unloaded using this function.
This list describes the unloading workflow, starting from the time of the unloading request: o
If the rack is in a module sample buffer or the rack loading/unloading area at this time, the remaining test orders for samples on the selected rack are masked ( M ).
o
If the rack is in an analyzer module at this time, the test orders on this module will be measured. Remaining test orders for other modules will be suspended and are also indicated as masked ( M ).
o
The instrument unloads the rack to the unloading tray regardless of the rack supply source. o
When you reload the sample to the instrument, the masked tests are processed without reordering.
q An unloading process takes about 15 minutes on average.
Once you have requested the unloading of a sample, the unloading process cannot be stopped.
p To unload a sample rack
1 Choose Workplace > Data Review .
2 Select a sample to be unloaded from the list on the left.
3 Choose Unload Rack to display the confirmation window.
4 Choose Yes to confirm unloading of this rack.
On the Data Review submenu, samples on the rack currently being unloaded are displayed in blue.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 13-9 The blue rack is selected for unloading ( Data Review submenu) o
The selected rack is unloaded to the unloading tray as fast as possible. o
The remaining test orders for samples on the selected rack are masked ( M ).
s
317
13 Workplace
Data Review submenu
Changing the priority of sample racks
cobas® 8000 modular analyzer series
Use the following procedure to increase the priority of single routine or rerun racks if the results are urgently needed. The samples on the selected racks are processed with
STAT priority. The rack type remains unchanged. This function is not applicable to
STAT, calibrator, and control racks.
Racks supplied via the STAT port are already processed with STAT priority. The priority of these racks cannot be increased by this function.
p To change the priority of a sample rack
1
Choose Workplace > Data Review during an analysis run.
2
Select the urgent sample from the list on the left.
3
Choose Change Priority to display the confirmation window.
4
Choose Yes to process this rack with STAT priority.
On the Data Review submenu, the samples on the prioritized rack are displayed in red.
q
Figure 13-10 The prioritized sample is red ( Data Review submenu)
STAT priority cannot be assigned to racks that have been selected for unloading.
s
Roche Diagnostics
318 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Data Review submenu
Viewing the status of controls on the Test Review window
The status of control data can be viewed on the Data Review submenu and the Test
Review window.
The St.
column on the Test Review window indicates the status of each test.
O (Ordered)
P (Processing)
No character (Complete)
I (Incomplete)
V (Validation)
M (Mask Test)
E (Edited Test)
Test was requested but not yet pipetted.
Test is being processed.
Test successfully processed.
Control result was successfully validated by the data manager.
A data alarm occurred on processing the sample, or one or more tests were masked.
Control result violates a QC rule or no QC rule was assigned on the data manager.
Control result has been sent to the data manager, but validation is not completed yet.
Test has been masked due to an abnormality during processing. Displayed only on Workplace > Data Review
> Test Review .
Possible reasons: Auto masking due to failed calibration, reagent pack is masked (empty or not on board), pretreatment or diluent required by immunoassay is not on board, test is manually masked, measuring channel is masked, dilution step is selected but cannot be carried out, or hardware problems.
Test result has been manually edited on Workplace > Data
Review > Test Review .
Use the following procedure to view the status of control measurements on the Test
Review window.
p To view the status of control measurements on the Test Review window
1 Choose Workplace > Data Review .
2 Select the control to be viewed from the list on the left.
Roche Diagnostics
Operator’s Manual · 4.2.1
319
13 Workplace
Data Review submenu cobas® 8000 modular analyzer series
3 Choose Test Review to display the Test Review window. This window displays more information on the control data.
Roche Diagnostics
320
Figure 13-11 Test Review window – controls
4 Check the Alarm column for data flags.
q QC Err
QC Err in the Alarm column indicates that the result violates a QC rule or that no QC rules were defined in the data manager component Westgard Rule Assignment .
u
For details, see QCErr (p. 869).
u
For a description of other alarms, see
5
Check the DM column. If an H is displayed, the result was already sent to the data manager.
6
Check the St.
column. The following statuses are important for QC results:
No character (Complete)
I (Incomplete)
V (Validation)
Control result was successfully validated by the data manager.
Control result violates a QC rule or no QC rule was assigned on the data manager.
Control result has been sent to the data manager, but validation is not completed yet. u
For more information on the Test Review window, please refer to the Online Help .
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Data Review submenu
Archiving patient data
Use this function to make backup copies of test results on a storage medium (DVD).
u
For more information about the different backup options, see:
Archiving data and performing data backups (p. 504)
p To archive patient data
1
Choose Workplace > Data Review .
2
Select the samples for which data is to be backed up from the list on the left of the screen.
3
Choose Backup Data to display the Backup Data window.
Roche Diagnostics
Operator’s Manual · 4.2.1
q
Figure 13-12 Backup Data window
4 Select the type of output in the Output area.
o
Data Backup
All data is stored in binary format. This format cannot be read by other PC systems but can be restored to the cobas 8000 instrument.
o
Results (CSV) or Reaction Data (CSV)
Patient results or reaction data is stored in CSV (comma separated values) format. This is a flexible, ASCII based format that can be used by other PC systems, for example, in a spread sheet program, but cannot be restored to the cobas 8000 instrument.
The check box With double quotation mark is only available when Results (CSV) or
Reaction Data (CSV) is selected.
q Do not start a data backup just after a DVD was inserted (as long as the access lamp is still blinking). Do not shut down the instrument before the DVD is taken out of the PC.
Otherwise, the data backup may not be executed correctly.
5 Insert the storage medium (DVD) into the corresponding disk drive.
6 Choose the button ( ) to display the Save As window to choose the path, and type in the file name.
Or: Type the path and the file name in the File Name text box.
321
13 Workplace
Data Review submenu cobas® 8000 modular analyzer series
7 Choose OK to back up the selected data.
s
Displaying archived patient data
Only data saved in binary format (*.mdf format) can be reloaded onto the instrument.
u
Archiving patient data (p. 321)
Reloaded data can only be viewed on the Data Review submenu.
p To display archived patient data
1
Make sure that the computer can access the medium that contains the data
(DVD)
2
Choose Workplace > Data Review .
3
Select Backup View from the Data list box to display the Read Backup window.
Figure 13-13 Read Backup window
4 Choose the button ( ) to display the Open File window and search for the file where data is saved.
Or: Type the path to the file where the data is saved in the File Name text box.
5 Choose OK . The saved data is displayed on Workplace > Data Review .
s
Roche Diagnostics
322 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Calib. Review submenu
To display this submenu, choose Workplace > Calib. Review .
13 Workplace
Calib. Review submenu
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 13-14 Calib. Review submenu
Use this submenu to review the status of the calibrators used during operation. Select the calibrator in the left list to review the status of the calibrations performed for each test.
The data displayed on this submenu are automatically deleted when the instrument is powered off. The data are updated every 5.4 s.
During Standby, it is possible to delete a calibrator with the Delete Calibrator button or a calibration test with the Delete Test button.
u
For a detailed description of all elements on this submenu, please refer to the Online
Help.
323
13 Workplace
Calib. Review submenu
Calibrator selection list
cobas® 8000 modular analyzer series
After a calibration was performed, the list on the left side of the screen displays the calibrators registered by the system. Up to 100 calibrators can be registered. The list can be sorted by Rack No.-Pos.
or by Calibrator .
q The width of the individual columns can be adjusted by clicking the column dividers in the column header and dragging them to the left or right.
St.
The St.
column displays the calibrator status codes:
P (Processing)
F (Failed)
S (Successful)
The calibrator is registered by the analyzer (barcode was already read). At least one calibration is running for the calibrator.
At least one calibration performed with this calibrator could not generate a valid calibration.
Calibrator successfully processed. All calibrations performed with this calibrator have generated valid calibration results.
Test results list
The list on the right side of the screen displays details of the tests performed with the calibrator currently selected in the list on the left. Only the last calibration for each test is shown.
q If a calibration for the same test and for the same reagent is measured again, the information in the row of this test will be overwritten.
St.
The St.
column displays the calibrator status codes:
No character
P (Processing)
F (Failed)
S (Successful)
Calibration measurement was not performed so far, for example, because of a cancellation during calibration measurement as a result of a sample clot or sample short.
The calibrator for the test is registered by the analyzer
(barcode was already read) and at least one calibration is requested for this calibrator. If the calibrator has already been pipetted by the analyzer, a pipetting date and time is available.
No valid calibration has been generated for the test.
A valid calibration has been generated for the test.
u
For more information about the calibration status, see Status submenu (p. 422).
Roche Diagnostics
324 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 13 Workplace
Calib. Review submenu
Deleting a calibrator or a calibrated test
In the Standby mode, calibrator data displayed on the Calib. Review submenu can be deleted if required.
q After powering on the system, the Calib. Review submenu is reset and all data are deleted automatically.
The manual deletion of data may be useful after a change of the calibrator lot or if you need room for additional calibrators.
Use the following procedures to delete the status of a calibrator or a test.
p To delete a calibrator
1 Choose Workplace > Calib. Review .
2 Select a calibrator to be deleted from the list on the left of the screen.
The calibrator is highlighted in gray.
3 Choose the Delete Calibrator button to delete the calibrator after confirmation.
s p To delete a test
1
Choose Workplace > Calib. Review .
2
Select a test to be deleted from the list on the right of the screen.
The calibration test is highlighted in gray.
3
Choose the Delete Test button to delete the calibration test after confirmation.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
325
13 Workplace
Calib. Review submenu cobas® 8000 modular analyzer series
Roche Diagnostics
326 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Reagents
14 Reagents
14
At the beginning of this chapter you will find information about reagent management with the software. This refers to all modules (overall system).
Information that refers to a single analytical module is given in the following sections, such as information about the reagents used and the related procedures.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
14
Columns in the Reagent Setting submenu ........................................................ 334
Reagent Overview window (cobas ISE module)..................................................... 339
Reagent Overview window (cobas c 701 and c 702 module)................................ 350
Registering reagents manually (Development Channel) ................................. 355
327
14 Reagents
Table of contents cobas® 8000 modular analyzer series
Reagent Overview window (cobas c 701 and c 702 module)................................ 365
Unloading reagents from the unloading tray.................................................... 371
Registering reagents manually (Development Channel) ................................. 377
Reagent Overview window (cobas c 502 module).................................................. 386
Registering reagents manually (Development Channel) ................................. 389
Pretreatment reagents and the PT link function .............................................. 397
Reagent Overview window (cobas e 602 module).................................................. 401
Replacing ProCell and CleanCell (cobas e 602 module) ................................. 406
Replacing consumables and emptying solid waste (cobas e 602 module)........... 409
Roche Diagnostics
328 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (overall system)
Reagents (overall system)
Chapter structure This chapter is separated into a module-independent section (overall system) and a section for each module.
The sections referring to each module contain information on the reagents used in this module and how the reagents need to be loaded and unloaded.
Introduction
Reagent container
Each module of the cobas 8000 instrument uses different reagents. The following table provides you with an overview of the commonalities and differences of reagent management on each module: c 701 cobas c pack large c 702 cobas c pack large c 502 cobas c pack
Identification label
Types of reagent
RFID label
Reagent, diluent, detergent, special reagent
RFID label
Reagent, diluent, detergent, special reagent
Standby or Operation
Barcode label
Reagent, diluent, detergent
Status of instrument or module during reagent replacement
Standby or module in
Standby (masked)
Standby or Operation
Loading and unloading of reagents
Registration of new reagent
Manually o
Manual registration o
Calibrate if recommended by software
Automatic loader/unloader Automatic loader/unloader o
Automatic registration o
Calibrate if recommended by software o
Automatic registration o
Calibrate if recommended by software
Detection of an empty reagent
Automatic reagent change over
(in case of an empty reagent)
Table 14-1
Yes
Yes, if a standby reagent pack is on board.
Yes
Yes, if a standby reagent pack is on board.
Commonalities and differences of the reagents on photometric modules
Yes
Yes, if a standby reagent pack is on board.
Reagent container
ISE
Containers with 2 L and 0.5 L; two reagent container sets on double
ISE units e 602 cobas e pack
Identification label
No barcode or RFID label Barcode label
Types of reagent
Status of instrument or module during reagent replacement
Loading and unloading of reagents
Table 14-2
ISE REF, ISE IS, ISE DIL
Standby or module in Standby (masked)
Manually
Commonalities and differences of the reagents on ISE and e 602 modules
Assay, diluent, pretreatment
Standby or module in Standby (masked)
Manually
Roche Diagnostics
Operator’s Manual · 4.2.1
329
14 Reagents
Reagents (overall system) cobas® 8000 modular analyzer series
Registration of new reagent
ISE o o
Reset volume
Prime o
Calibrate always e 602 o o
Automatic registration
Calibrate if recommended by software
Detection of an empty reagent
Automatic reagent change over
(in case of an empty reagent)
Table 14-2
Yes (countdown)
No, replacement required (no standby reagent bottle).
Commonalities and differences of the reagents on ISE and e 602 modules
Yes
Yes, if a standby reagent pack is on board.
q The term reagent pack is used generally to refer to cobas c packs, cobas e packs, and other reagent containers.
Menu summary
Submenu
Reagent > Setting submenu
The following sections describe how reagents are managed with the cobas 8000 instrument software.
Function
The Reagent > Setting submenu is used to perform the following: o
To view details on the reagents on each module, including lot o number, expiration date (shelf life) and the on-board stability o
To register newly loaded reagents o
To prime reagents (ISE and e 602 module) o
To reset the remaining volume
To view information about reagent pack sets u
See
Reagent > Status submenu
The Reagent > Status submenu is used to perform the following: o
To check the remaining volumes of reagents o
To reset the remaining volumes of ISE and auxiliary reagents o
Entering ProCell lot numbers ( e 602 only) u
See
Table 14-3 Reagent menu overview
Roche Diagnostics
330 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (overall system)
Color scheme for reagent levels
The following colors are used on the Reagent submenus to indicate low reagent levels:
Color
Red
Yellow
Purple
White
Table 14-4
Meaning
A reagent, diluent, or pretreatment is empty on this module. The corresponding tests cannot be performed (reagent masking) until the reagent is loaded.
For e 602 only: An assay or pretreatment reagent pack could not be linked to the required partner reagent pack (link status Free ). Partner reagent is not on board.
The number of tests remaining for a reagent is less than the yellow alarm level. Levels are defined under Utility > System > Reagent Level .
For c 702 only: Reagent packs on the buffer rotor are taken into account when calculating the remaining reagent of a test. If the total remaining reagent on a reagent disk or on the entire module is lower than the yellow limit, a yellow alarm is issued.
The number of tests remaining for a reagent is less than the purple alarm level (daily requirement). Only applicable if the Preventive Action check box on the Overview menu is selected.
The amount of reagent on this module is sufficient.
Color scheme for reagents
Reagent types
The following abbreviations are used on the Reagent submenus:
Module
ISE c 701 / c 702 / c 502
Reagent
IS 1/2
DIL 1/2
REF 1/2
SmpCln 1,
SmpCln 2
Rx
CellCln 1,
CellCln 2
D1 or NAOHD
D2 or SMS
D3 or SCCS
DIL or NACL
Ecotergent
(ECO-D)
SmpCln 1,
SmpCln 2
SPR
Description
Internal standard solution for ISE unit 1/2
Diluent for ISE unit 1/2
Reference solution KCL for ISE unit 1/2
Sample probe wash solutions
(SmpCln 1 = basic wash, SmpCln 2 = acid wash)
Reagent for photometric measurement, x stands for the pipetting time-point (R1, R2, or R3)
Cell wash solutions
(CellCln 1 = NaOH-D, CellCln 2 = acid wash)
Detergent / NAOHD for washing the reagent probes and reaction cells when using maintenance item
(7) Wash Reaction Parts and if programmed for special washes
Detergent / SMS for washing the reagent probes if programmed for special washes
Special Cell Cleaning Solution for c 502 modules.
Diluent / NaCl
Ecotergent (surfactant for the incubator bath)
Sample probe wash solutions
(SmpCln 1 = basic wash, SmpCln 2 = acid wash)
Special reagent ( c 701 / c 702 only), can be used by multiple applications as third reagent
Table 14-5 Reagent types
Roche Diagnostics
Operator’s Manual · 4.2.1
331
14 Reagents
Reagents (overall system) cobas® 8000 modular analyzer series
Module e 602 e 602 Inventory
( Reagent
> Status submenu)
Reagent
ASSAY
DIL
PRE
CleanCell (CC)
PreClean
ProCell (PC)
ProbeWash
Description
Assay reagent pack (current or standby)
Diluent reagent pack
Pretreatment reagent pack
Cleaning solution for measuring cells after measurement
Washing solution for microbeads (for certain assays only)
Signal generating buffer for the ECL detection
Cleaning solution for the reagent probes to prevent carryover
Table 14-5 Reagent types u
For details on the reagents used on a particular module, see:
Reagent concept (cobas ISE module) (p. 336)
Reagent concept (cobas c 701 module) (p. 345)
Reagent concept (cobas c 702 module) (p. 358)
Reagent concept (cobas c 502 module) (p. 381)
Reagent concept (cobas e 602 module) (p. 394).
Roche Diagnostics
332 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Setting submenu
To display this submenu, choose Reagent > Setting .
14 Reagents
Reagents (overall system)
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 14-1 Reagent > Setting submenu
Use the Setting submenu to view details of reagents currently loaded on the modules.
The compiled data include reagent code, lot number, expiration date (shelf life) as well as the on-board stability of the reagents (in days). The buttons at the bottom of the screen allow you to register newly loaded reagents or to execute a reagent prime, for example.
Examples of tasks that can be performed from this submenu: o ISE module:
O
Prime reagents
O Reset the remaining volume of reagents after replacement o c 702 module:
O Register reagents
O
Unload cobas c packs
O Display information about reagent pack sets
O
Register cobas c packs MULTI o c 701 module:
O
Register reagents after cobas c packs have been loaded
O Display information about reagent pack sets
O
Register cobas c packs MULTI o c 502 module:
O
Unload cobas c packs
O Register cobas c packs MULTI o e 602 module:
O Prime auxiliary reagents
O
Register cobas e packs manually
333
14 Reagents
Reagents (overall system) cobas® 8000 modular analyzer series
Including Reagent Manager check box ( c 702)
Select this check box if you want to display the remaining number of tests including those of reagents packs present in the buffer rotor of the reagent manager.
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Columns in the Reagent Setting submenu
The list on the Reagent > Setting submenu displays information on all reagents on the selected module. Some important columns in this list are described in the following:
Mark This column displays information related to the reagent registration.
An asterisk (*) indicates manually registered reagents which are used for
Development Channel applications.
For c 702 modules only: A minus sign (-) indicates that the cobas c pack is reserved for unloading.
u
For more information on manually registered reagents, see:
Registering reagents manually (Development Channel) (p. 377).
Test This column displays the short test name of the reagent currently loaded in the corresponding reagent position.
Available Tests This column displays the total number of tests available for all reagent packs of a specific test which are currently loaded on the module.
The number in parentheses (if present) represents the level set for the purple alarm.
If no reagent is available for this test, a red “0” is displayed in this column.
Masked reagent packs are taken into account for the number of Available Tests . If all reagent packs for a test are masked, a red “0” is displayed in this column.
Remaining This column displays the number of tests remaining for a single reagent pack. For diluents and auxiliary reagents, the remaining volume is displayed.
Exp. Date This column displays two expiration dates: The first one displays the expiration date
(shelf life) of the reagent in the corresponding position.
The second expiration date (number in parentheses) displays the on-board stability of the reagent (in days).
o
If the shelf life is expired, the expiration date is displayed in red.
o If the on-board stability is exceeded, a red (0) is displayed.
Roche Diagnostics
334
A B
A Shelf life of reagent expired (ReagEx flag attached to result)
Figure 14-2
B On-board stability exceeded on reagent disk
(OBS.RR flag attached to result)
Expiration date and on-board stability on Reagent > Setting
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
14 Reagents
Reagents (overall system)
Incorrect results due to expired reagents or mixing reagents
Results obtained using expired reagents are not reliable. Mixing new reagent and residues of old reagent may also lead to incorrect results.
r Do not use reagents that have exceeded their expiration dates.
r Do not top off old reagent with new reagent. When a reagent pack is empty, replace it with a new one.
Status submenu
To display this submenu, choose Reagent > Status .
B
A
C
Roche Diagnostics
Operator’s Manual · 4.2.1
A Test list
Figure 14-3
B R. Pack list: Reagents provided in reagent packs
C Inventory list: Auxiliary reagents and consumables provided in bottles or containers
Reagent > Status submenu
Use the Status submenu to view the status of the reagents currently loaded on the instrument. The data are sorted according to the names of the applications and displayed either for all modules or for one specified module. Moreover, there is an additional list, which provides information about auxiliary reagents.
Examples of tasks that can be performed from this submenu: o Check the remaining volumes of reagents (current and standby) and consumables o
Reset the remaining volume of ISE and auxiliary reagents o Prime ISE reagents and e 602 auxiliary reagents
For a detailed description of all elements on this submenu, please refer to the Online
Help.
335
14 Reagents
Reagents (cobas ISE module)
Reagents (cobas ISE module)
cobas® 8000 modular analyzer series
This section provides information about the reagents and auxiliary reagents used on the ISE module, and how they are used for ISE applications.
Reagent concept (cobas ISE module)
This section describes all reagents necessary to run the ISE module and the reagents that are specific for each available ISE application.
The following ISE applications are available: o
Na
+
: Sodium serum/plasma and urine o
K
+
: Potassium serum/plasma and urine o
Cl
-
: Chloride serum/plasma and urine
Reference information for ISE reagents
The following table compiles reference information for the ISE reagents, calibrators, and controls.
Product name Short name (1) , Code Container type
Reagents for measurements
Calibrators
(2)
ISE Internal Standard
ISE Diluent
ISE Reference Electrolyte
ISE Standard low (S1)
ISE Standard high (S2)
Quality controls (examples):
Table 14-6
ISE Standard high (S3)
Precinorm U or
Precinorm U plus
Precipath U or
Precipath U plus
ISE reagents, calibrators, and QCs
ISE IS
ISE DIL
ISE REF
ISE Low (S1), 502
ISE High (S2), 503
ISE High (S3), 763
PNU
PPU
1 container
1 container
1 container
Calibrator rack with standard sample tubes or standard cups.
QC rack with standard sample tubes or standard cups.
(1) used in this documentation
(2) The calibration interval is 24 hours for all ISE applications. Calibrators are also called standards.
(3) Hitachi micro cups, non-standard tubes and false bottom tubes must not be used for calibrators and controls.
For details see:
Which container for which application?
(3)
(3)
Roche Diagnostics
336 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas ISE module)
Reagents for measurements
Each ISE measurement uses the following reagents: o
Internal standard (ISE IS), used for one-point calibrations performed before and after each sample measurement o
Reference solution (ISE REF), used for reference electrode measurements o
Diluent (ISE DIL), used for dilution of samples
The ISE reagents (ISE IS, ISE REF, ISE DIL) are supplied in reagent containers and do not use a barcode for registration. The ISE reagent containers can only be replaced if the instrument or the module is in Standby ( Start (global button) > Masking
> Module Masking ).
ISE reagent registration After the replacement of an ISE reagent container, the following steps are required:
1. Reset the remaining volume to the initial value ( registration ).
2. Perform a reagent prime to fill the flow path with the new liquid.
3. Calibrate the ISE unit.
u
For information on replacing ISE reagents, see:
Replacing reagents (cobas ISE module) (p. 341).
Remaining volume count For each reagent type, the instrument monitors the remaining volume. When the test count of an ISE reagent becomes “0”, all ISE tests will be masked and thus no subsequent measurement is possible.
The expiration date of ISE reagents is not monitored by the software.
Calibrators and controls
Calibrators ISE calibrators are used with or without barcodes. The following calibrators are used for two-point calibrations and full calibrations: o
ISE Low (S1) [Std(1)]: water-based solution, used for two-point calibrations and for full calibrations o
ISE High (S2) [Std(2)]: water-based solution, used for two-point calibrations and for full calibrations o
ISE High (S3) [Std(3)]: serum-based solution, used for blank calibrations, full calibrations q o The calibration interval for all ISE applications is 24 hours.
o The instrument software can automatically recommend an ISE calibration every
24 hours if this is set under Utility > Application > Calib .
o When barcoded ISE calibrators are used, no position assignment is required.
u
To assign positions for non-barcoded calibrators, see:
Assigning calibrator positions (p. 426).
Quality controls The following products are examples for quality controls: o
PNU o
PPU
Quality controls can be used either with or without barcodes. u
See Controls with or without barcodes (p. 456)
Roche Diagnostics
Operator’s Manual · 4.2.1
337
14 Reagents
Reagents (cobas ISE module) cobas® 8000 modular analyzer series
Auxiliary reagents (ISE module)
The ISE module uses the following auxiliary reagents:
Product name
Sample Cleaner 1
Sample Cleaner 2
Sample Cleaner 1
ISE cleaning solution SysClean
Activator
Short name
(1)
SmpCln 1
SmpCln 2
SmpCln 1
Activator
Description
Basic cleaning solution for the sample probe
Acid cleaning solution for the sample probe
For washing the sample probe, used by maintenance procedure
(2)
For washing the ISE flow path, used by maintenance procedure
(2)
For conditioning the ISE electrodes, used by maintenance procedure
(2)
Container type Position
1 container
1 container
Sampling area
Sample tube or cup on green wash rack
Rack Pos. 1
Rack Pos. 2
Rack Pos. 3
Table 14-7 ISE auxiliary reagents
(1) used in this documentation and the instrument software
(2) See Processing green wash rack (p. 646)
Remaining volume control For SmpCln 1 and SmpCln 2, the remaining volumes are displayed on the Reagent
> Status submenu. The remaining volumes are monitored by liquid level detection.
Whenever a reagent container is replaced, the operator has to reset the initial volume manually . u
For information on monitoring the reagents and resetting the initial volume, see:
Replacing auxiliary reagents (cobas ISE module) (p. 344).
Roche Diagnostics
338 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas ISE module)
Reagent Overview window (cobas ISE module)
On the Overview menu, choose the button that symbolizes an ISE measuring unit.
The Reagent Overview window is displayed for the ISE module.
This window consists of three areas: o
Contents area: Explanation of colors used in the Reagent and the Inventory area o
Reagent area: Status of the ISE reagents o
Inventory area: Status of the auxiliary reagents
A
B
Roche Diagnostics
Operator’s Manual · 4.2.1
A ISE unit 1
Figure 14-4
Abbreviation
IS
DIL
REF
SmpCln 1
SmpCln 2
Table 14-8
B ISE unit 2 (for twin modules only)
Reagent Overview window (ISE module)
Unit mL mL mL mL mL
ISE reagent types
Description
Internal standard solution (ISE IS)
Diluent (ISE DIL)
Reference solution (ISE REF, KCl)
Sample Cleaner 1 (basic wash)
Sample Cleaner 2 (acid wash)
Reagent area The Reagent area displays the remaining volume by using bar charts. The first colored box below each bar chart indicates the remaining volume of the ISE reagent.
The two lower color-coded boxes provide additional information on the statuses of calibration and QC.
339
14 Reagents
Reagents (cobas ISE module) cobas® 8000 modular analyzer series
A B C
D
A ISE IS
B ISE DIL
C ISE REF
Figure 14-5
E
F
G
D Bar-chart for the remaining volume
E Remaining volume of the reagent container
F Calibration status
G QC status
Reagent area (ISE module)
For a detailed description of all elements on this window, please refer to the Online
Help.
Roche Diagnostics
340 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas ISE module)
Replacing reagents (cobas ISE module)
ISE IS, ISE DIL, and ISE REF are stored in reagent containers in the ISE reagent compartment behind the front door.
A D
B
C
E
F
CAUTION
A REF-2 - Reference solution
B IS-2 - Internal standard solution
C DIL-2 - Diluent
Figure 14-6 ISE reagents on the drawer
D REF-1 - Reference solution
E DIL-1 - Diluent
F IS-1 - Internal standard solution
Replace all required reagents as indicated on the Reagent Load/Unload List . Make sure to place them according to their specified positions.
The ISE reagent containers can only be replaced if the complete instrument is in
Standby or if the module is masked and in Standby.
Before performing the following actions, observe these safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Incorrect results due to missing covers of the ISE module (p. 231)
Incorrect results due to errors during ISE reagent replacement r Discard used reagent containers. Be sure to use a new container. Otherwise, inappropriate measurement result may occur.
r Execute Reagent Volume Reset after the replacement of a reagent container. This is required for appropriate reagent management.
r Execute Reagent Prime after the replacement of a reagent container.
r Take care to place the ISE reagent containers in the correct positions as labelled.
u
For information about the on-board stability of the application, please refer to the corresponding Instructions for Use on cobas e-library.
p To replace an ISE reagent container
1 Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
Roche Diagnostics
Operator’s Manual · 4.2.1
341
14 Reagents
Reagents (cobas ISE module) cobas® 8000 modular analyzer series
2 Open the front door of the ISE module.
3 Remove the tubing from the empty reagent container.
4 Check the aspiration filter at the end of the tube. Clean it if required.
u
See:
To clean the ISE reagent aspiration filters (p. 662)
A
CAUTION
A Correct
Figure 14-7 Replacing the ISE reagent aspiration filters
5 Insert the tube into the new container (
).
Incorrect results due to incorrect insertion of the ISE REF aspiration tube
If the aspiration tube is not inserted correctly, the reagent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube into the container all the way until its end touches the bottom of the container. r Do not bend the aspiration tube.
6 Replace the container.
7 Close the front door of the ISE module.
8 Choose Reagent > Status .
9 From the Inventory list, select the replaced reagent.
10 Choose Reagent Volume Reset to reset the volume count.
After replacing any ISE reagent, a Reagent Prime is required.
s
Roche Diagnostics
342 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CAUTION
14 Reagents
Reagents (cobas ISE module) p To perform a reagent prime
1 Choose one of the following options to open the Reagent Prime window: o
Overview > Reagent Preparing > Reagent Prime o
Reagent > Setting > Reagent Prime o
Utility > Maintenance , choose (8) Reagent Prime
2 Select the ISE module.
3 In the Prime Item list box, select All (or the reagent corresponding to the replaced container).
4 Enter 20 in the Cycles text box (recommended number of priming cycles).
5 Choose Execute .
The prime is complete when the instrument returns to Standby.
Whenever an ISE reagent was replaced, the ISE module must be recalibrated. A changeover recommendation is issued after the ISE reagent was reset.
6 If the module was masked, unmask it.
s p To request an ISE calibration
1
Make sure the ISE calibrators are placed into the rack loading area.
2
Choose Calibration > Status .
3
From the Test list, select the desired module ISE-1 or ISE-2 .
4
In the Method column, select the Full option and choose Save .
Incorrect results due to concentrated ISE calibrators
The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
r For ISE calibrations ensure that the calibrator is opened immediately before the calibration is performed.
u
For details on the ISE calibration, see:
Requesting and cancelling calibrations manually (p. 423)
Calibration (cobas ISE module) (p. 435).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
343
14 Reagents
Reagents (cobas ISE module)
Replacing auxiliary reagents (cobas ISE module)
cobas® 8000 modular analyzer series
CAUTION
When replacing ISE auxiliary reagents (sample probe detergent containers), you have to manually reset the reagent volume count in the software.
Incorrect results due to expired detergents
A detergent whose stability has expired must not be used. Otherwise, measurement may fail to achieve a correct result.
r Avoid adding a new detergent to the old one. Otherwise, measurement may fail to achieve a correct result.
p To replace a sample probe detergent
1 Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2 Open the top cover of the module.
Roche Diagnostics
344
A
B
A D1 SmpCln 1 (basic wash)
B D2 SmpCln 2 (acid wash)
Figure 14-8 Replacing sample probe detergents
3
Replace the required reagent container.
4
Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
Reagents (cobas c 701 module)
This section provides information about the reagents used on the c 701 module. It explains how the instrument registers new reagents and how it monitors reagent consumption.
Reagent concept (cobas c 701 module)
This section describes all reagents necessary to run the module, including diluents and auxiliary reagents (such as basic and acid detergents).
The following application types are available on this module: o
Enzymes o
Substrates o
Specific proteins o
Therapeutic drug monitoring (TDM) o
Drugs of abuse testing (DAT) o
Serum indices o
And others
Reagent packs – cobas c packs large
Apart from various reagent containers for auxiliary reagents, cobas c packs are the principal reagent containers for photometric applications.
B C
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 14-9 cobas c pack large with position designations B and C
345
14 Reagents
Reagents (cobas c 701 module) cobas® 8000 modular analyzer series
Two types of reagent packs are available for this module: o cobas c pack large – ready-to-use reagent pack o cobas c pack MULTI – empty reagent pack for Development Channel applications
Configurations of cobas c packs large
Each cobas c pack large contains two reagent bottles. With the product label facing to the front, the left position is position B and the right position is position C. Pipettings at different timings (R1, R2, or R3) are not restricted to any position.
The following configurations are available: cobas c pack large
Configuration 1
Configuration 2
Table 14-9
Volume in mL
(1)
90
60
Bottle volumes of cobas c packs large
Volume in mL
(1)
30
60
(1) The given volumes are maximum volumes and do not denote the amount of reagent available in a specific reagent pack.
As cobas c packs large can contain only one or two reagents, applications with three pipettings at R1, R2 and R3 require a separate cobas c pack for the additional reagent.
Two concepts are used to provide the additional reagent: o
Reagent pack sets o
Special reagents
Reagent pack sets The three reagents can be supplied in a set of up to two cobas c packs. After registration, both reagent packs are treated as a unit.
Information about the second reagent pack of this set is displayed in the lower area of the R. Packs Setting window under Utility > Application > Analyze .
u
For information about breaking up a reagent pack set, see:
Unloading reagent pack sets (p. 354).
Special reagents If the additional reagent can be used by multiple assays, this is called a special reagent
(abbreviation SPR on the Reagent menu). Assays do not need to be recalibrated after a change of the reagent pack or lot of the special reagent.
Up to ten special reagents can be registered in the Utility > System > Utility Reagent
Settings window.
On the Utility > Application submenu, the application code number of the special reagent and the pipetting timing is set. Special reagents can be assigned to R1, R2, and
R3, but only one type of reagent for a test can be assigned to a special reagent. For development channel applications no special reagent setting is available.
When a special reagent pack includes multiple bottles of the same reagent, only one bottle at a time is used. When one bottle is empty, the system changes over to the next bottle. When one reagent pack is empty, the system changes over to the standby reagent pack. cobas c pack MULTI The cobas c pack MULTI is an empty reagent pack. These reagent packs can be used, for example, for lyophilized reagents, which have to be mixed with diluent just prior to use. To prepare a cobas c pack MULTI for use on the instrument, follow the instructions given in the Instructions for Use.
Roche Diagnostics
346 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
Development channel applications Development channel applications can be performed using a cobas c pack MULTI.
The reagent information, such as test name and reagent disk position, must be registered manually. On the Reagent > Setting submenu, the position of a manually registered reagent is indicated with a * symbol in the Mark column.
Note that no reagent changeover operation is performed for development channel reagents.
Only one reagent pack or set of a development channel application can be assigned to each reagent disk (A or B) of one analytical module.
Radio Frequency Identification
Label
The cobas c packs large are equipped with a Radio Frequency Identification Label
(RFID label) on the top of the reagent pack. The instrument scans this label during reagent registration. q If a reagent pack label is unreadable, an instrument alarm is issued. This cobas c pack cannot be used on the instrument. The identification cannot be entered manually.
Reagent registration and remaining volume control
A liquid level detection (LLD) and a foam detection is performed by the reagent probes for each reagent.
When reagent packs are loaded during Standby, reagent registration must be performed manually and in this case all reagent packs are checked. If registration was not performed manually, it will be performed automatically during Preparation. Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
The number of remaining tests is calculated from the reagent level measured by LLD.
During operation, the instrument counts every pipetting out of the reagent packs.
If the total number of available tests for an application on one module is lower than a defined limit, the instrument can issue an alarm. Therefore, the yellow and purple alarm levels must be set for each application under Utility > System > Reagent Level .
When the number of available tests becomes zero, a red alarm is issued and the test is masked—unless another reagent pack is available as a standby reagent or on a second module.
q Foam detection
To ensure accurate level detection, the reagent probes check for foam inside all newly loaded reagent packs which were not used yet. The foam check is not applicable to cobas c packs MULTI. If foam is detected, this reagent pack is masked and an alarm is issued.
Remove this reagent pack briefly until the foam has gone.
Carryover prevention Even though all pipetter probes and reaction cells are washed and rinsed thoroughly after each use, traces of sample or reagent may remain on contacted parts (probes or reaction cells) and are carried over at the next pipetting.
By means of the special wash function, the instrument prevents traces of sample or reagent from being carried over to another test and biasing the results of the latter.
u
For more information on programming special washes, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
347
14 Reagents
Reagents (cobas c 701 module)
Diluents cobas® 8000 modular analyzer series
Calibrators and controls
Reagent pack short name
NaCl
Table 14-10
Reagent pack long name
Comment
NaCl 9%
Diluents for photometric tests
Diluent for photometric tests
NaCl For photometric applications, either water or a NaCl solution is used for dilution of samples. The water is deionized water from the instrument’s water tank. NaCl solution is supplied in cobas c packs NaCl 9% .
Whenever used as diluent, the 9% solution from the cobas c pack is diluted with water to a concentration of 0.9% by the instrument.
q Make sure you have sufficient diluent on the module—especially if a higher demand of diluent can be expected.
To monitor the remaining amount of NaCl diluent, set a reagent warning level.
For photometric applications, universal calibrators and special calibrators are available. The same universal calibrator is used for a large number of applications whereas a special calibrator covers only a few or only one application.
Universal calibrators for photometric applications are CFAS (without diluent), CFAS
Proteins, or CFAS Proteins Urine/CSF.
Likewise, there are universal and special controls.
Universal quality controls are PNU and PPU, for example.
Usually, calibrators and controls have to be reconstituted and pipetted into cups or tubes. For measurement, place calibrators onto black calibrator racks and controls onto white QC racks.
u
For information about calibrators and quality controls for specific applications, refer to the corresponding Instructions for Use.
Roche Diagnostics
348 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
Auxiliary reagents (cobas c 701 module)
The following auxiliary reagents are used on the module:
Name
Cell cleaner 1
Short name
(1)
CellCln 1
Description Container type
Cell cleaner 2
Sample Cleaner 1
Sample Cleaner 2
Sample Cleaner 1
Ecotergent
CellCln 2
SmpCln 1
SmpCln 2
SmpCln 1
Ecotergent
Basic cell wash solution (NaOH-D), used for rinsing and cleaning of reaction cells
Acid cell wash solution, used for specific tests for rinsing and cleaning of reaction cells
Basic cleaning solution for sample probes
Acid cleaning solution for sample probes
1 container
1 container
1 container
1 container
For washing the sample probe, used by maintenance procedure with green wash rack
Sample tube or cup on green wash rack
Surfactant for incubator bath to prevent foaming reagent pack
NAOHD NAOHD
( D1 )
SMS ( D2 )
Auxiliary reagents
Detergent 1 for reagent probe wash and cell wash
(Maintenance item (7) Wash Reaction Parts) reagent pack
Detergent 2 for reagent probe wash and cell wash reagent pack SMS
Table 14-11
(1) Used in this documentation and the instrument software
Position
Behind the front doors
Sample probe area
Rack Pos. 1
On outer ring of reagent disk B only!
On reagent disk A and B
Remaining volume control The remaining volumes are displayed on the Reagent > Status submenu.
The instrument uses different methods to monitor the remaining volumes of the auxiliary reagents. The monitoring method used depends on the type of reagent container: o
Large containers (CellCln 1 and CellCln 2): The remaining volumes of these reagents are monitored by countdown, starting from a given initial volume.
Whenever a reagent container is replaced, the operator has to reset the initial volume manually . By resetting the remaining volume, the reagent is registered.
o
Small containers (SmpCln 1 and SmpCln 2): The remaining volumes of these reagents are monitored by liquid level detection. Whenever a reagent container is replaced, the operator has to reset the initial volume manually .
o
Reagent packs (NAOHD, SMS, Ecotergent, and special reagents): The remaining volumes of these reagents are checked by liquid level detection during reagent registration and monitored by countdown. Reagent registration can be performed manually in Standby when a new cobas c pack is loaded. Otherwise it will be performed automatically during Preparation.
u
For information on monitoring the reagents and resetting the initial volume, see:
Replacing auxiliary reagents (cobas c 702 module) (p. 378)
u
For information on monitoring cobas c packs, see:
Reagent registration c 702 module (p. 1157)
Roche Diagnostics
Operator’s Manual · 4.2.1
349
14 Reagents
Reagents (cobas c 701 module) cobas® 8000 modular analyzer series
Reagent Overview window (cobas c 701 and c 702 module)
On the Overview menu, choose the button that symbolizes the two reagent disks. The
Reagent Overview window for the corresponding module is displayed. The appearance of this window is the same for c 701 and c 702 modules.
The window consists of three areas: o
Contents area: Explanation of colors used in the Reagent and the Inventory area o
Reagent area: Status of the reagent packs on the two reagent disks of this module o
Inventory area: Status of the auxiliary reagents
D
A
B
C
E
Roche Diagnostics
350
A Inner segment: R.P. (reagent pack)
B Middle segment: Cal. (calibration)
C Outer segment: QC (Quality Control)
Figure 14-10
D
E
Remaining volumes of CellCln 1 / CellCln 2
Remaining volumes of SmpCln 1/ SmpCln 2
Reagent Overview window ( c 701 / c 702 module) q A reagent mandatory message is displayed on the Reagent Overview window when the module is shown red on the Overview menu. This may occur if a reagent is not loaded or not available.
This function is available only if the test of the missing reagent has been defined as mandatory under Utility > System Configuration > Test Assignment .
Reagent area Use this area to view the status of the reagent packs loaded on the two reagent disks.
This area comprises a graphic representing the reagent disks A and B.
Each reagent disk is represented by two rings. The inner ring has 10 positions for reagent packs and the outer ring 25 positions; that means, 70 positions on one module.
Each reagent pack is subdivided into three segments. The colors of each segment correspond to the following statuses: o
R. P.
: Reagent pack status (inner segment) o
Cal.
: Calibration status (middle segment) o
QC : QC status (outer segment)
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
Detailed information about a reagent pack
Choose a reagent disk (A or B) to magnify the graphic of the selected reagent disk.
Choose a single reagent pack by choosing a segment. Detailed information about the reagent pack (e.g., Position , Test Name , Remaining Tests , and Calibration Date ) is displayed next to the graphic.
Figure 14-11 Detail window for a selected reagent pack
Choose the R. Pack Mask button to exclude a reagent pack from analysis temporarily.
For a detailed description of all elements on this window, please refer to the Online
Help.
Roche Diagnostics
Operator’s Manual · 4.2.1
351
14 Reagents
Reagents (cobas c 701 module) cobas® 8000 modular analyzer series
Replacing reagent packs (cobas c 701 module)
On the c 701 module, the cobas c packs must be loaded and unloaded manually.
Loading reagent packs
CAUTION
Load all required reagents and auxiliary reagents as indicated on the Reagent
Load/Unload List .
Incorrect results due to bubbles or foam inside a cobas c pack
Bubbles or foam inside a cobas c pack may cause inadequate pipetting volume and lead to deterioration in measurement accuracy. r Do not shake reagents.
r When loading a cobas c pack large, make sure neither bubbles nor foam are present inside the reagent pack.
r If the module detects foam on the surface of the reagent, this reagent pack will be masked. Remove this reagent pack briefly until the foam has gone.
q Multiple reagent packs with the same reagent o More than one reagent pack can be placed in each reagent disk . When the current reagent pack is empty, the system automatically changes over to the next one (standby reagent pack).
The order of precedence of standby reagents is assessed by the time the reagent was registered; the oldest reagent is used first. The order of precedence is indicated on the
Reagent Overview window as Current (active), SB1 (first standby), SB2 (second standby), and so on.
o In case of a multi-module configuration of the same module type, the same reagent can be placed on several modules.
Before performing the following actions, observe these safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Incorrect results due to expired reagents or mixing reagents (p. 230)
r
Incorrect results due to wrong temperature of the incubator (p. 232)
Roche Diagnostics
352 p To load cobas c packs
1
Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2
Print a Reagent Load/Unload List (or choose Overview > Reagent Overview ) to check for any empty cobas c packs.
3
Open the covers of reagent disk A (left) and B (right).
4
In case you want to remove one reagent pack from a reagent pack set , ungroup it before removal. Choose Reagent > Setting > R. Pack Set Information > Break
Up .
5
Remove and discard empty cobas c packs.
6
Carefully unscrew the caps from the new cobas c packs. Avoid spillage and foam formation. You may use the cobas c pack opener which is a semiautomatic device that eases and accelerates opening of cobas c packs.
7
Visually check that there is no foam inside the bottles of the cobas c pack.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module) q
8 Place new cobas c packs into empty positions on the reagent disks (with the white part of the RFID label facing to the left). Reagent pack sets must be placed on the same disk.
Orientation of cobas c packs
If a cobas c pack is inserted the wrong way round, a yellow alarm (Reagent Pack
Opposite Direction) will be issued. The reagent pack will not be displayed in the
Reagent menu.
Ecotergent reagent packs must be placed on the outer ring of reagent disk B.
A B C
Roche Diagnostics
Operator’s Manual · 4.2.1
A Reagent disk A
B Reagent disk B
C Label on the cobas c pack facing to the left
Figure 14-12 Placing cobas c packs on the reagent disks
9 Close the reagent disk covers. Otherwise, the reagent temperature may become inaccurate, leading to incorrect results.
10 From the Reagent > Setting submenu, perform a Reagent Registration for the corresponding c 701 module.
Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
11 On the Setting submenu, check that the values of Available Tests , Type , Lot ID , and Exp. Date of the new reagent packs are appropriate.
s
353
14 Reagents
Reagents (cobas c 701 module) cobas® 8000 modular analyzer series
Unloading and reloading reagents
Unloading reagents Reagent packs are unloaded manually from the reagent disks.
Unloading reagent pack sets If one reagent pack of a reagent pack set is empty, the set can be broken up using
Reagent > Setting > R. Pack Set Information > Break Up . Then the reagent pack that still contains reagent can be used until empty. It can be grouped together with another fresh reagent pack.
If both reagent packs in the reagent pack set are empty, it is not necessary to break up the set.
Reloading reagents Already used cobas c packs can be unloaded and stored according to the storage conditions (see Instructions for Use).
A used cobas c pack can be reloaded onto another module of the same type within the same cobas 8000 instrument. We recommend not to transfer a reagent pack from c 702 to c 701, or vice versa, due to the information written on the RFID label.
CAUTION
Incorrect results due to reloading of reagent packs r Never load a used reagent pack onto another cobas 8000 instrument; otherwise information about reagent volume and on-board stability are missing, which may lead to incorrect results.
r Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument.
r Never refill a reagent pack. Discard empty reagent packs.
p To unload reagent packs
1
Check for reagent packs that need to be replaced: o
Choose Reagent > Setting and select a c 701 module. or, o
Choose Overview and select the Reagent Overview button for a c 701 module.
2 In case the second reagent pack from a reagent pack set still contains reagent, break up the set before removal. Choose Reagent > Setting > R. Pack Set
Information > Break Up .
3 Make sure that the module is in Standby.
4 Open the top cover and the covers of the reagent disks.
5 Take out the reagent packs.
6 Store the reagent packs refrigerated or discard them, respectively.
s
Roche Diagnostics
354 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
Registering reagents manually (Development Channel)
Development Channel applications must be registered manually on the module.
Since the same development channel barcode is used for all development channel applications, the cobas c pack MULTI has to be assigned to a development channel application before loading onto the analyzer.
q A description for loading Development Channel applications is available on the cobas e-library. Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche representative for more information.
p To register a cobas c pack manually on a c 701 module
1
Make sure that the instrument is in Standby.
2
In case you want to remove a manually registered reagent pack, delete it before removal. Select the reagent pack and choose Reagent > Setting > Delete .
3
Prepare the reagent in a cobas c pack MULTI (see Instructions for Use).
4
Check that there is no foam inside the bottles of the cobas c pack MULTI.
5
Place the new cobas c pack MULTI into an empty position on the reagent disks
(with the white part of the RFID label facing to the left). Reagent pack sets must be placed on the same disk.
6
Close the reagent disk covers.
7
Select the Position and choose Reagent > Setting > Manual Registration .
8
Select the Test Name and Type of the reagent and choose OK .
9
From the Reagent > Setting submenu, perform a Reagent Registration for the corresponding c 701 module.
Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
10
On the Setting submenu, check that the values of Available Tests , Type , Lot ID , and Exp. Date of the new reagent packs are appropriate.
s
Replacing auxiliary reagents (cobas c 701 module)
Replacing a container and resetting the reagent volume
When replacing auxiliary reagent containers (such as cell detergent or sample probe detergent containers), you must manually reset the reagent volume count.
CAUTION
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. r
Observe in particular the following safety label on the instrument: F-5 (p. 41).
CAUTION
Improper aspiration of detergent due to foam or air bubbles
If you shake the new detergent container before placing it on the instrument, the detergent may form foam or air bubbles.
r Do not shake the detergent containers before placing them on the instrument.
Roche Diagnostics
Operator’s Manual · 4.2.1
355
14 Reagents
Reagents (cobas c 701 module) cobas® 8000 modular analyzer series
CAUTION
Incorrect results due to errors when replacing auxiliary reagents
The detergent volume is monitored by counting down from the initial volume. If the volume counter is not reset correctly, this may cause detergent shortage, leading to incorrect results.
r Ensure to reset the volume counter after the replacement of a container.
r Always replace empty containers with new and full ones.
r Only reset the volume counter after a new container has been placed.
Follow the procedures below to replace detergent containers: p To replace a cell detergent container
1 Make sure that the instrument is in Standby or powered off.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2 Open the front doors of the module.
CAUTION
Roche Diagnostics
356
A B
A CellCln 1
B CellCln 2
Figure 14-13 Removing the detergent aspiration filters
3
Take out the empty detergent container and remove the aspiration tube.
4
Check the aspiration filter at the end of the tube. Clean it if required.
u
See:
To clean the detergent aspiration filters (p. 725)
5
Insert the tube into the new container.
Incorrect results due to incorrect insertion of aspiration tube
If the aspiration tube is not inserted correctly, the detergent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube so that the end of the tube touches the bottom of the container. r Do not bend the aspiration tube.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 701 module)
6 Replace the container and close the front door.
7 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s p To replace a sample probe detergent
1
Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2
Open the rear cover of the module.
3
Remove the screws of the plexiglass cover to remove it.
CAUTION
A B
A Position 1 = SmpCln 1 (basic wash)
B Position 2 = SmpCln 2 (acid wash)
Figure 14-14 Sample probe cleaners (view through rear cover)
4
Replace the required detergent container.
Incorrect results due to carryover caused by detergent shortage
If the remaining volume counter is not reset after replacement, a detergent shortage may potentially go undetected, leading to sample carryover.
r Always reset the remaining volume after replacement of a sample probe cleaner.
r Do not replenish detergent bottles.
5 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s
Roche Diagnostics
Operator’s Manual · 4.2.1
357
14 Reagents
Reagents (cobas c 702 module)
Reagents (cobas c 702 module)
cobas® 8000 modular analyzer series
This section provides information about the reagents used on the c 702 module. It explains how the instrument registers new reagents and how it monitors reagent consumption.
Reagent concept (cobas c 702 module)
This section describes all reagents necessary to run the module, including diluents and auxiliary reagents (such as basic and acid detergents).
The following application types are available on this module: o
Enzymes o
Substrates o
Specific proteins o
Therapeutic drug monitoring (TDM) o
Drugs of abuse testing (DAT) o
Serum indices o
And others
Reagent packs – cobas c packs large
Apart from various reagent containers for auxiliary reagents, cobas c packs are the principal reagent containers for photometric applications.
B C
Roche Diagnostics
358
Figure 14-15 cobas c pack large with position designations B and C
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
Two types of reagent packs are available for this module: o cobas c pack large – ready-to-use reagent pack o cobas c pack MULTI – empty reagent pack for Development Channel applications
Configurations of cobas c packs large
Each cobas c pack large contains two reagent bottles. With the product label facing to the front, the left position is position B and the right position is position C. Pipettings at different timings (R1, R2, or R3) are not restricted to any position.
The following configurations are available: cobas c pack large
Configuration 1
Configuration 2
Table 14-12
Volume in mL
(1)
90
60
Bottle volumes of cobas c packs large
Volume in mL
(1)
30
60
(1) The given volumes are maximum volumes and do not denote the amount of reagent available in a specific reagent pack.
As cobas c packs large can contain only one or two reagents, applications with three pipettings at R1, R2 and R3 require a separate cobas c pack for the additional reagent.
Two concepts are used to provide the additional reagent: o
Reagent pack sets o
Special reagents
Reagent pack sets The three reagents can be supplied in a set of up to two cobas c packs. After registration, both reagent packs are treated as a unit.
Information about the second reagent pack of this set is displayed in the lower area of the R. Packs Setting window under Utility > Application > Analyze .
u
For information about breaking up a reagent pack set, see:
Unloading reagent pack sets (p. 372).
Special reagents If the additional reagent can be used by multiple assays, this is called a special reagent
(abbreviation SPR on the Reagent menu). Assays do not need to be recalibrated after a change of the reagent pack or lot of the special reagent.
Up to ten special reagents can be registered in the Utility > System > Utility Reagent
Settings window.
On the Utility > Application submenu, the application code number of the special reagent and the pipetting timing is set. Special reagents can be assigned to R1, R2, and
R3, but only one type of reagent for a test can be assigned to a special reagent. For development channel applications no special reagent setting is available.
When a special reagent pack includes multiple bottles of the same reagent, only one bottle at a time is used. When one bottle is empty, the system changes over to the next bottle. When one reagent pack is empty, the system changes over to the standby reagent pack. cobas c pack MULTI The cobas c pack MULTI is an empty reagent pack. These reagent packs can be used, for example, for lyophilized reagents, which have to be mixed with diluent just prior to use. To prepare a cobas c pack MULTI for use on the instrument, follow the instructions given in the Instructions for Use.
Roche Diagnostics
Operator’s Manual · 4.2.1
359
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
Development channel applications Development channel applications can be performed using a cobas c pack MULTI.
The reagent information, such as test name and reagent disk position, must be registered manually. On the Reagent > Setting submenu, the position of a manually registered reagent is indicated with a * symbol in the Mark column.
Note that no reagent changeover operation is performed for development channel reagents.
Only one reagent pack or set of a development channel application can be assigned to each reagent disk (A or B) of one analytical module.
Radio Frequency Identification
Label
The cobas c packs large are equipped with a Radio Frequency Identification Label
(RFID label) on the top of the reagent pack. The instrument scans this label during reagent registration. q If a reagent pack label is unreadable, an instrument alarm is issued. This cobas c pack cannot be used on the instrument. The identification cannot be entered manually.
Reagent workflow ( c 702 only) This list describes the reagent workflow with the reagent manager:
1. The operator places a reagent pack on the loading port of the reagent manager.
2. The reagent manager checks the orientation of the reagent pack. The test name on the label must be facing left.
3. The reagent pack is drawn in when the green LED is on.
4. The RFID label is read to identify the reagent pack. If it cannot be read, the reagent pack is unloaded via the return port.
5. Depending on the loading mode selected with the buttons, the reagent pack is kept on the buffer rotor inside the reagent manager, or it is loaded directly.
6. Just before transportation to a reagent disk, the reagent pack is uncapped.
7. Empty reagent packs are transported to the unloading tray where they can be removed.
q The RFID reader is located in the reagent manager, not on the reagent disks. Therefore, reagent packs cannot be loaded onto a reagent disk manually.
Loading limits There are three types of limits for loading of reagent packs on the c 702 module: o
Loading limit: The general loading limit is set to 15 tests per reagent disk. This is not adjustable and not shown in the user interface. If the remaining number of tests falls below this limit, a loading trigger is issued and the loading process starts even if the instrument is in operation . The required reagent packs must be available in the buffer rotor, of course.
u
See:
o
If the remaining number of tests falls below the Yellow Loading Limit , a yellow alarm is issued. Reagent packs with a yellow loading limit alarm waiting on the reagent manager are loaded directly during Standby or Rack Reception Mode .
During operation , the waiting reagent pack is added to the loading queue and will be loaded in the next loading session triggered by another reagent pack.
o
The Initial Loading Limit does not influence loading. The ratio of the remaining number of tests to this limit is only printed out on the Reagent Load/Unload List .
The Yellow Loading Limit and the Initial Loading Limit are set on the Utility
> System > Reagent Loading Level window.
u
See: Reagent Loading Level (cobas c 702 module) (p. 530)
Roche Diagnostics
360 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
Loading triggers Reagent packs on the buffer rotor are loaded if there are vacant positions on the reagent disks. These factors can initiate the loading process:
Trigger Loading starts …
Below the loading limit
Manual loading
… when the remaining amount of a reagent pack falls below: o
Assay reagents: 15 tests o
Diluent DIL: 0.54 mL o
D1 and D2: 1.25 mL o
Ecotergent: 10.8 mL
… when the Loading option on the Reagent
Manager Overview window was selected manually.
On-board stability time
… when the Reagent Manager On-Board
Stability Time of a reagent pack in the buffer rotor is below or equal to zero.
Open reagent pack
Gap between measurements
Table 14-13
… when an open reagent pack is loaded onto the buffer rotor.
… when all results are output and no analysis is scheduled.
Loading triggers during Operation or Standby
Status
Operation or
Standby
Operation or
Standby
Operation or
Standby
Operation or
Standby
Operation only
Loading is performed automatically: The rack transfer to this module is stopped.
After all remaining samples in the processing line are pipetted and the last
R3 pipetting is done, the loading process starts.
Unloading triggers These factors can initiate the unloading process during operation:
Trigger Unloading starts …
Unloading when loading
Time to unloading
… when loading was initiated by a loading trigger. Then the gripper also unloads reagent packs on the way back from the reagent disks.
… after the set time and if the module is not busy (no sample scheduled for the module and all results are output).
The time is set under Time To Unload on the Utility > System
> Reagent Manager Settings window.
… when the system goes into Standby, except when this was forced by an abnormal termination like an alarm.
When going into
Standby
Rack Reception Mode … when the system goes into Rack Reception Mode.
Manual unloading … when the R. Pack Unloading option on the Reagent > Setting window was selected. During operation, the module stops sample processing and unloads the reserved reagent packs as soon as the reagent manager is available.
Table 14-14 Unloading triggers during operation
Roche Diagnostics
Operator’s Manual · 4.2.1
361
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
Reagent registration and remaining volume control
When reagent packs are loaded during operation, reagent registration is performed on the c 702 module automatically. This means that a liquid level detection (LLD) and a foam detection are performed by the reagent probes for newly loaded reagents.
When you loaded reagent packs during Standby, observe the following: o
If you start operation after loading reagent packs, registration will be performed automatically during Preparation or Operation.
o
If you perform a maintenance item that requires reagents (e.g., (5) Incubation
Water Exchange) after loading reagent packs, you must start the reagent registration either manually or by a maintenance pipe.
New reagent packs are displayed on Calibration > Status and are thus available for calibration after the reagent registration has been performed.
The number of remaining tests is calculated from the reagent level measured by LLD.
During operation, the instrument counts every pipetting out of the reagent packs.
If the total number of available tests for an application on one module is lower than a defined limit, the instrument can issue an alarm. Therefore, the yellow and purple alarm levels must be set for each application under Utility > System > Reagent Level .
When the number of available tests becomes zero, a red alarm is issued and the test is masked—unless another reagent pack is available as a standby reagent or on a second module.
q Foam detection
To ensure accurate level detection, the reagent probes check for foam inside all newly loaded reagent packs which were not used yet. The foam check is not applicable to cobas c packs MULTI. If foam is detected, this reagent pack is masked and an alarm is issued. This reagent pack is automatically reserved for unloading.
Carryover prevention Even though all pipetter probes and reaction cells are washed and rinsed thoroughly after each use, traces of sample or reagent may remain on contacted parts (probes or reaction cells) and are carried over at the next pipetting.
By means of the special wash function, the instrument prevents traces of sample or reagent from being carried over to another test and biasing the results of the latter.
u
For more information on programming special washes, see:
Diluents
Reagent pack short name
NaCl
Table 14-15
Reagent pack long name
Comment
NaCl 9%
Diluents for photometric tests
Diluent for photometric tests
NaCl For photometric applications, either water or a NaCl solution is used for dilution of samples. The water is deionized water from the instrument’s water tank. NaCl solution is supplied in cobas c packs NaCl 9% .
Whenever used as diluent, the 9% solution from the cobas c pack is diluted with water to a concentration of 0.9% by the instrument.
Roche Diagnostics
362 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module) q Make sure you have sufficient diluent on the module—especially if a higher demand of diluent can be expected.
To monitor the remaining amount of NaCl diluent, set a reagent warning level.
Calibrators and controls
For photometric applications, universal calibrators and special calibrators are available. The same universal calibrator is used for a large number of applications whereas a special calibrator covers only a few or only one application.
Universal calibrators for photometric applications are CFAS (without diluent), CFAS
Proteins, or CFAS Proteins Urine/CSF.
Likewise, there are universal and special controls.
Universal quality controls are PNU and PPU, for example.
Usually, calibrators and controls have to be reconstituted and pipetted into cups or tubes. For measurement, place calibrators onto black calibrator racks and controls onto white QC racks.
u
For information about calibrators and quality controls for specific applications, refer to the corresponding Instructions for Use.
Roche Diagnostics
Operator’s Manual · 4.2.1
363
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
Auxiliary reagents (cobas c 702 module)
The following auxiliary reagents are used on the module:
Name
Cell cleaner 1
Short name
(1)
CellCln 1
Description Container type
Cell cleaner 2
Sample Cleaner 1
Sample Cleaner 2
Sample Cleaner 1
Ecotergent
CellCln 2
SmpCln 1
SmpCln 2
SmpCln 1
Ecotergent
Basic cell wash solution (NaOH-D), used for rinsing and cleaning of reaction cells
Acid cell wash solution, used for specific tests for rinsing and cleaning of reaction cells
Basic cleaning solution for sample probes
Acid cleaning solution for sample probes
1 container
1 container
1 container
1 container
For washing the sample probe, used by maintenance procedure with green wash rack
Sample tube or cup on green wash rack
Surfactant for incubator bath to prevent foaming reagent pack
NAOHD NAOHD
( D1 )
SMS ( D2 )
Auxiliary reagents
Detergent 1 for reagent probe wash and cell wash
(Maintenance item (7) Wash Reaction Parts) reagent pack
Detergent 2 for reagent probe wash and cell wash reagent pack SMS
Table 14-16
(1) Used in this documentation and the instrument software
Position
Behind the front doors
Sample probe area
Rack Pos. 1
On outer ring of reagent disk B only!
On reagent disk A and B
Remaining volume control The remaining volumes are displayed on the Reagent > Status submenu.
The instrument uses different methods to monitor the remaining volumes of the auxiliary reagents. The monitoring method used depends on the type of reagent container: o
Large containers (CellCln 1 and CellCln 2): The remaining volumes of these reagents are monitored by countdown, starting from a given initial volume.
Whenever a reagent container is replaced, the operator has to reset the initial volume manually . By resetting the remaining volume, the reagent is registered.
o
Small containers (SmpCln 1 and SmpCln 2): The remaining volumes of these reagents are monitored by liquid level detection. Whenever a reagent container is replaced, the operator has to reset the initial volume manually .
o
Reagent packs (NAOHD, SMS, Ecotergent, and special reagents): The remaining volumes of these reagents are checked by liquid level detection during reagent registration and monitored by countdown. Reagent registration can be performed manually in Standby when a new cobas c pack is loaded. Otherwise it will be performed automatically during Preparation.
u
For information on monitoring the reagents and resetting the initial volume, see:
Replacing auxiliary reagents (cobas c 702 module) (p. 378)
u
For information on monitoring cobas c packs, see:
Reagent registration c 702 module (p. 1157)
Roche Diagnostics
364 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
Reagent Overview window (cobas c 701 and c 702 module)
On the Overview menu, choose the button that symbolizes the two reagent disks. The
Reagent Overview window for the corresponding module is displayed. The appearance of this window is the same for c 701 and c 702 modules.
The window consists of three areas: o
Contents area: Explanation of colors used in the Reagent and the Inventory area o
Reagent area: Status of the reagent packs on the two reagent disks of this module o
Inventory area: Status of the auxiliary reagents
D
A
B
C
E
A Inner segment: R.P. (reagent pack)
B Middle segment: Cal. (calibration)
C Outer segment: QC (Quality Control)
Figure 14-16
D
E
Remaining volumes of CellCln 1 / CellCln 2
Remaining volumes of SmpCln 1/ SmpCln 2
Reagent Overview window ( c 701 / c 702 module) q A reagent mandatory message is displayed on the Reagent Overview window when the module is shown red on the Overview menu. This may occur if a reagent is not loaded or not available.
This function is available only if the test of the missing reagent has been defined as mandatory under Utility > System Configuration > Test Assignment .
Roche Diagnostics
Operator’s Manual · 4.2.1
Reagent area Use this area to view the status of the reagent packs loaded on the two reagent disks.
This area comprises a graphic representing the reagent disks A and B.
Each reagent disk is represented by two rings. The inner ring has 10 positions for reagent packs and the outer ring 25 positions; that means, 70 positions on one module.
Each reagent pack is subdivided into three segments. The colors of each segment correspond to the following statuses: o
R. P.
: Reagent pack status (inner segment) o
Cal.
: Calibration status (middle segment) o
QC : QC status (outer segment)
365
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
Detailed information about a reagent pack
Choose a reagent disk (A or B) to magnify the graphic of the selected reagent disk.
Choose a single reagent pack by choosing a segment. Detailed information about the reagent pack (e.g., Position , Test Name , Remaining Tests , and Calibration Date ) is displayed next to the graphic.
Figure 14-17 Detail window for a selected reagent pack
Choose the R. Pack Mask button to exclude a reagent pack from analysis temporarily.
For a detailed description of all elements on this window, please refer to the Online
Help.
Replacing reagent packs (cobas c 702 module)
WARNING
The reagent manager automatically triggers the loading and unloading of reagent packs. A gripper transfers the reagent packs from the buffer rotor to the reagent disks, and from there to the unloading tray.
The reagent manager allows you to load reagent packs when the green LED at the loading port is on (during Standby or Operation).
Injury or incorrect results when replacing a jammed reagent pack
In case a reagent pack got jammed during the loading or unloading process, do NOT place it manually into a reagent disk and do NOT replace it by another reagent pack. There are no RFID readers inside the c 702 reagent disks. Thus, a misplaced reagent pack cannot be detected and would lead to incorrect results.
r Remove a jammed reagent pack manually in Standby mode. r Be careful when removing open reagent packs from the instrument. Be sure to wear protective equipment (such as gloves).
r Reload the reagent pack via the loading port.
Roche Diagnostics
366 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
Loading reagent packs
Load all required reagents and auxiliary reagents as indicated on the Reagent
Load/Unload List .
Loading modes The reagent manager supports two loading modes: o
Buffering mode ( BUFFER button): The reagent pack is kept on the buffer rotor inside the reagent manager. The system decides when and to which reagent disk the reagent pack is loaded (depending on the inventory status).
If desired, the target disk can be specified manually on the Reagent Manager
Overview window after a reagent pack was already loaded.
o
Direct mode (3 lower buttons): The reagent pack is loaded directly if a free position is available. The target reagent disk can be selected automatically
( AUTO ) by the system or manually by pressing one of the buttons A or B .
A B C D E
F
G
Roche Diagnostics
Operator’s Manual · 4.2.1
A Button for disk A (Direct mode)
B Auto button (Direct mode)
C Buffer button (Buffering mode)
D Button for disk B (Direct mode)
Figure 14-18 Control panel and loading port
E Status LED: Calibration
F Loading port and status LED
G Return port and status LED
Mode
Buffering
Direct
Table 14-17
Button Description
BUFFER The reagent pack remains on the buffer rotor until needed.
The system decides about loading time and target reagent disk.
AUTO Loads the reagent pack as soon as possible. The target reagent disk is assigned by the system.
If the module is in Standby, the reagent is loaded immediately.
During operation, the reagent is loaded when the status changes to Reagent Loading (S.Stop).
A or B Loads the reagent pack as soon as possible to disk A or B.
If the module is in Standby, the reagent is loaded immediately.
During operation, the reagent is loaded when the status changes to Reagent Loading (S.Stop).
Loading modes
367
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series q Selected loading mode remains active
The selected mode remains active until another mode is selected.
Status indicators on the reagent manager
Yellow LED (E)
(calibration status)
Green LED (F)
(loading status)
Off
Calibration not required.
Operating:
Transfer session is active.
Reagent packs are not loaded.
On
Calibration recommended for a reagent pack in the buffer rotor.
Check the Reagent Manager
Overview window.
u
To manually control reagent packs on the buffer rotor (p. 370)
Table 14-18
Access ok:
There are vacant positions on the buffer rotor. Reagent packs can be loaded.
Status indicators on the reagent manager
Yellow LED (G)
(return port)
No access.
Access ok:
Reagent pack can be taken out.
CAUTION
Incorrect results due to bubbles or foam inside a cobas c pack
Bubbles or foam inside a cobas c pack may cause inadequate pipetting volume and lead to deterioration in measurement accuracy. r Do not shake reagents. r If the module detects foam on the surface of the reagent, this reagent pack will be masked and reserved for unloading. Remove this reagent pack briefly until the foam has gone.
q Multiple reagent packs with the same reagent o More than one reagent pack can be placed in each reagent disk . When the current reagent pack is empty, the system automatically changes over to the next one (standby reagent pack).
The order of precedence of standby reagents is assessed by the time the reagent was registered; the oldest reagent is used first. The order of precedence is indicated on the
Reagent Overview window as Current (active), SB1 (first standby), SB2 (second standby), and so on.
o In case of a multi-module configuration of the same module type, the same reagent can be placed on several modules.
Before performing the following actions, observe these safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Incorrect results due to expired reagents or mixing reagents (p. 230)
r
Incorrect results due to wrong temperature of the incubator (p. 232)
p To load cobas c packs
1
Print a Reagent Load/Unload List (or choose Overview > Reagent Overview ) to check for required reagent packs.
2
Select the loading mode on the control panel (table 14-17 , p. 367).
Roche Diagnostics
368 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
3 Make sure that the green status LED at the loading port is ON.
A B
Roche Diagnostics
Operator’s Manual · 4.2.1
q
A Label on the left side of the reagent pack
B Status LED at the loading port
Figure 14-19 Loading a cobas c pack at the loading port
4 Place a cobas c pack onto the loading port. The reagent pack will be drawn into the reagent manager automatically.
Up to 10 reagent packs can be loaded within a loading session. The LED turns off when the buffer rotor is full.
Orientation of cobas c packs
The test name on the label must be facing left. Otherwise, the reagent pack will not be drawn into the reagent manager.
q Timeout for loading of reagent packs
After 10 seconds have passed since the last loading or when the buffer rotor is full, the module switches to the transfer session. A new reagent pack will not be accepted until the session is completed. The green LED is switched off.
Reagent pack sets must be loaded within one transfer session. A single reagent pack from a pair will be ejected at the return port.
q
5 From the Reagent > Setting submenu, perform a Reagent Registration for the corresponding c 702 module.
Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
6 On the Setting submenu, check that the values of Available Tests , Type , Lot ID , and Exp. Date of the new reagent packs are appropriate.
If the Including Reagent Manager check box is selected, reagent packs on the reagent manager can also be checked. In the Position column they are labeled with
M-1 to M-10.
s
369
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series p To manually control reagent packs on the buffer rotor
1 Choose Overview .
2 Choose the buffer rotor button of the c 702 module sample buffer.
The Reagent Manager Overview window is displayed.
A
Roche Diagnostics
370
A Graphic of a reagent pack
Figure 14-20 Reagent Manager Overview window
3 Select the graphic of the desired reagent pack.
4 To specify a target reagent disk, select the reagent disk A or B from the list box at the right of the reagent pack.
q q
Preconditions
The list box can only be changed if the following conditions are met: o The reagent pack was loaded in Buffering mode.
o The module is in Standby or Operation mode.
o The test(s) was/were assigned to both reagent disks.
o The status shown below the list box is not Loading… or Take out… .
5 Choose Update .
6 To force the loading process of a reagent pack, select one of the options: o Choose Loading to load a reagent pack now .
or, o
Choose Loading Reserve to load it during the next transfer session .
If Loading is not available (message “cannot be performed in current mode” appears), choose Loading Reserve . Afterwards Loading can be ordered.
7 Choose Update again if you have chosen a loading option.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
8 If the yellow LED at the control panel is on, one or more reagent packs require a calibration. Perform a calibration after the reagent has been transferred to a reagent disk.
s
Unloading reagents from the unloading tray
Unloading reagents Reagent packs are transported to the unloading tray in the following cases: o
Empty reagent packs o
Reagent packs with detected foam o
Reagent packs from a reagent pack set that was broken up o
Reagent packs that were manually selected for unloading
Reagent packs can be removed from the unloading tray at any time when the green
LED is on.
WARNING
This section comprises two different unloading actions: o
To take out automatically unloaded reagent packs from the unloading tray (p. 373)
o
To manually select reagent packs for unloading (p. 374)
Skin inflammation or injury caused by reagent residue
Direct contact with assay reagents or detergents may cause skin irritation or inflammation.
r Be careful when removing open reagent packs from the instrument. They may contain reagent residue.
r Exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as gloves).
r Open the unloading tray only when the green LED (
NOTICE Damage to the instrument when the unloading tray is open r Do not open the top cover when the unloading tray is open.
q Reagent packs can be unloaded from the reagent disks automatically at a set time, for example, at the end of daily routine. This function is called Time to Unload Mode .
u
See: Reagent Manager Settings (cobas c 702 module) (p. 524).
Roche Diagnostics
Operator’s Manual · 4.2.1
371
14 Reagents
Reagents (cobas c 702 module)
Status LEDs for unloading reagents cobas® 8000 modular analyzer series
A
A Status: Access to drawer (green LED)
Figure 14-21 LEDs at the unloading tray
B
B Status of reagent packs (yellow LED)
Off
On
Table 14-19
Green LED (A)
(access to drawer)
Yellow LED (B)
(reagent packs)
All reagent packs are empty.
Operating
DO NOT open
Drawer safe to open
Take out reagent packs.
Status indicators at the unloading tray
Reagent packs containing reagent on the right lane. Be careful not to spill reagent.
Unloading reagent pack sets If one reagent pack of a reagent pack set is empty, the set can be broken up using
Reagent > Setting > R. Pack Set Information > Break Up . Then the reagent pack that still contains reagent can be used until empty. It can be grouped together with another fresh reagent pack.
If both reagent packs in the reagent pack set are empty, it is not necessary to break up the set.
Reloading reagents Already used cobas c packs can be unloaded and stored according to the storage conditions (see Instructions for Use).
A used cobas c pack can be reloaded onto another module of the same type within the same cobas 8000 instrument. We recommend not to transfer a reagent pack from c 702 to c 701, or vice versa, due to the information written on the RFID label.
CAUTION
Incorrect results due to reloading of reagent packs r Never load a used reagent pack onto another cobas 8000 instrument; otherwise information about reagent volume and on-board stability are missing, which may lead to incorrect results.
r Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument.
r Never refill a reagent pack. Discard empty reagent packs.
Roche Diagnostics
372 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module) p To take out automatically unloaded reagent packs from the unloading tray
1
Make sure that the green LED at the unloading tray is ON.
2
Open the hatch door of the unloading tray and pull the drawer out all the way.
q The drawer must be fully opened. Otherwise the system will not reset the inventory of the reagent packs present on the tray.
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A Lane for empty reagent packs
B Lane especially for reagent packs containing reagent
Figure 14-22 Unloading reagent packs
B q Left and right lane in the unloading tray o Left lane: Accommodates empty reagent packs.
o Right lane: Accommodates reagent packs containing reagent (yellow LED is on).
o When there are no reagent packs containing reagent, the right lane also accommodates empty reagent packs (yellow LED is off).
3
Remove and discard empty cobas c packs.
4
Take out filled reagent packs, being careful not to spill the content.
5
Push back the drawer and close the hatch door.
6
Choose Overview .
373
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
7 Choose the unloading area button of the c 702 module.
The Reagent Pack Unloading Area window is displayed.
Roche Diagnostics
374
Figure 14-23 Reagent Pack Unloading Area window
8 Check that the inventory was reset.
After removing, no reagent pack should be displayed.
s p To manually select reagent packs for unloading q We recommend keeping reagent packs on board until they are empty.
1 Choose Reagent > Setting .
2 Select a c 702 module from the Module list.
3 If the second reagent pack from a reagent pack set still contains reagent, break up the set before removal. Choose Reagent > Setting > R. Pack Set Information
> Break Up .
4 Select the cobas c pack you want to unload.
The line is highlighted in gray.
5 Choose R. Pack Unloading to open the corresponding window.
Figure 14-24 R. Pack Unloading window
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
NOTICE q
6 Choose Select R. Pack to unload the currently selected reagent.
If you choose All R. Pack , all reagent packs will be unloaded.
7 Choose OK .
8 Choose the unloading area button of the c 702 module.
The Reagent Pack Unloading Area window is displayed.
9 Check that the selected reagent packs have been transferred to the unloading tray.
10 Follow the unloading procedure described in the section. u
To take out automatically unloaded reagent packs from the unloading tray (p. 373)
11 Remove the reagent packs, being careful not to spill the content.
Damage to the instrument due to reused reagent caps
Reused caps may not be properly handled by the uncapping mechanism. When a temporarily stored reagent pack is loaded again, reused caps may come off accidentally and become stuck in the mechanism. Furthermore, traces of one reagent may remain on a cap and may contaminate the other reagent in the pack.
r Never reuse a reagent cap from the waste box.
s
Unloading reagents from the reagent manager and emptying the cap waste box
This section comprises two different unloading actions: o
To unload reagent packs from the reagent manager buffer rotor (p. 376)
o
To empty the cap waste box (p. 376)
Roche Diagnostics
Operator’s Manual · 4.2.1
A Cap waste box
Figure 14-25
A C
B Status of return port
C Return port
Cap waste box and return port
B
375
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
WARNING
Yellow LED (B) (return port)
Off
No access.
On
Table 14-20
Access ok:
Reagent pack can be taken out.
Status indicator at the return port q If an error occurs during loading of a reagent pack (wrong reagent pack, or RFID Label error) the reagent pack will be unloaded immediately through the return port. The LED left to the return port turns yellow.
p To unload reagent packs from the reagent manager buffer rotor
1 Choose Overview .
2 Choose the buffer rotor button of the c 702 module sample buffer.
The Reagent Manager Overview window is displayed.
3 Select the desired reagent pack.
4 Choose Take Out to open the corresponding window.
5 Choose either Select R. Pack or All R. Pack .
6 Choose OK .
The selected reagent pack(s) are transferred to the return port.
7 Open the flap at the return port and take the reagent pack out.
s p To empty the cap waste box
Skin inflammation or injury caused by reagent residue on reagent caps
Direct contact with assay reagents or detergents may cause skin irritation or inflammation.
r Empty the cap waste box periodically. Do not let its contents overflow or reagent spill over.
r Exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as gloves).
1 Choose Overview .
2 Make sure that the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until the module is in Standby.
3 Choose the buffer rotor button of the c 702 module sample buffer.
The Reagent Manager Overview window is displayed.
4 Take out the cap waste box and dispose the reagent caps.
5 Return the emptied cap waste box.
q If the cap waste box is not in the correct position, no reagent pack will be drawn into the buffer rotor.
6 Choose Waste Box Reset to reset the cap counter to zero.
s
Roche Diagnostics
376 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 702 module)
Registering reagents manually (Development Channel)
Development Channel applications must be registered manually on the module.
Since the same development channel barcode is used for all development channel applications, the cobas c pack MULTI has to be assigned to a development channel application before loading onto the analyzer.
q A description for loading Development Channel applications is available on the cobas e-library. Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche representative for more information.
q A reagent pack for a Development Channel application can be unloaded normally.
However, it cannot be reloaded onto the c 702 module as with other reagent packs.
p To register a cobas c pack manually on a c 702 module
1
Choose Reagent > Setting or Overview > Reagent Preparing .
2
Choose Development Channel .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 14-26 Development Channel window
3 Select the test in the list and choose Reserve . Confirm with OK .
4 Prepare the reagent in a cobas c pack MULTI (see Instructions for Use).
5 Check that there is no foam inside the bottles of the cobas c pack MULTI.
6 On the control panel of the reagent manager, push button A or B to specify a reagent disk (Direct mode).
7 Make sure that the green LED is ON and place the cobas c pack MULTI on the loading port.
8 After the reagent pack has been transferred to the reagent disk, choose Reagent
> Setting .
9 From the Reagent > Setting submenu, perform a Reagent Registration for the corresponding c 702 module.
Only successfully registered reagent packs are displayed on Calibration > Status and can be calibrated.
10 On the Setting submenu, check that the values of Available Tests , Type , Lot ID , and Exp. Date of the new reagent packs are appropriate.
s
377
14 Reagents
Reagents (cobas c 702 module)
Replacing auxiliary reagents (cobas c 702 module)
cobas® 8000 modular analyzer series
Replacing a container and resetting the reagent volume
When replacing auxiliary reagent containers (such as cell detergent or sample probe detergent containers), you must manually reset the reagent volume count.
CAUTION
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. r
Observe in particular the following safety label on the instrument: F-5 (p. 41).
CAUTION
CAUTION
Improper aspiration of detergent due to foam or air bubbles
If you shake the new detergent container before placing it on the instrument, the detergent may form foam or air bubbles.
r Do not shake the detergent containers before placing them on the instrument.
Incorrect results due to errors when replacing auxiliary reagents
The detergent volume is monitored by counting down from the initial volume. If the volume counter is not reset correctly, this may cause detergent shortage, leading to incorrect results.
r Ensure to reset the volume counter after the replacement of a container.
r Always replace empty containers with new and full ones.
r Only reset the volume counter after a new container has been placed.
Follow the procedures below to replace detergent containers: p To replace a cell detergent container
1 Make sure that the instrument is in Standby or powered off.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until the module is in Standby.
Roche Diagnostics
378 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
2 Open the front doors of the module.
14 Reagents
Reagents (cobas c 702 module)
CAUTION
A B
A CellCln 1
B CellCln 2
Figure 14-27 Removing the detergent aspiration filters
3
Take out the empty detergent container and remove the aspiration tube.
4
Check the aspiration filter at the end of the tube. Clean it if required.
u
See:
To clean the detergent aspiration filters (p. 725)
5
Insert the tube into the new container.
Incorrect results due to incorrect insertion of aspiration tube
If the aspiration tube is not inserted correctly, the detergent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube so that the end of the tube touches the bottom of the container. r Do not bend the aspiration tube.
6
Replace the container and close the front door.
7
Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s p To replace a sample probe detergent
1 Make sure that the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until the module is in Standby.
2 Open the rear cover of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
379
14 Reagents
Reagents (cobas c 702 module) cobas® 8000 modular analyzer series
3 Remove the screws of the plexiglass cover to remove it.
CAUTION
A B
A Position 1 = SmpCln 1 (basic wash)
B Position 2 = SmpCln 2 (acid wash)
Figure 14-28 Sample probe cleaners (view through rear cover)
4 Replace the required detergent container.
Incorrect results due to carryover caused by detergent shortage
If the remaining volume counter is not reset after replacement, a detergent shortage may potentially go undetected, leading to sample carryover.
r Always reset the remaining volume after replacement of a sample probe cleaner.
r Do not replenish detergent bottles.
5 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s
Roche Diagnostics
380 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module)
Reagents (cobas c 502 module)
This section provides information about the reagents used on the c 502 module. It explains how the instrument manages reagents and how they are loaded and unloaded.
Reagent concept (cobas c 502 module)
This section describes all reagents necessary to run the module, including diluents and auxiliary reagents (such as basic and acid detergents).
The following application types are available on this module: o
Enzymes o
Substrates o
Specific proteins o
Therapeutic drug monitoring (TDM) o
Drugs of abuse testing (DAT) o
Serum indices o
And others
Reagent packs – cobas c packs
Apart from various reagent containers for auxiliary reagents, cobas c packs are the principal reagent containers for photometric applications.
B A C
Roche Diagnostics
Operator’s Manual · 4.2.1
A Bottle position A
B Bottle position B
C Bottle position C
Figure 14-29 cobas c pack with position designations
381
14 Reagents
Reagents (cobas c 502 module) cobas® 8000 modular analyzer series
Two types of reagent packs are available for this module: o cobas c pack – ready-to-use reagent pack o cobas c pack MULTI – empty reagent pack for Development Channel applications
Configurations of cobas c packs Each cobas c pack can contain up to three reagent bottles. The center position is position A. Pipettings at different timings (R1, R2, or R3) are not restricted to any position.
Different configurations of cobas c packs are available. That is, in a cobas c pack the reagent bottles can vary in size. The following table lists the volumes of different reagent bottles within different reagent packs: cobas c pack Position B
Volume in mL (1)
Position A
Volume in mL cobas c pack configuration 1 40 – cobas c pack configuration 2 20 cobas c pack configuration 3 60
Table 14-21 Volumes of bottles in reagent packs
40
–
Position C
Volume in mL
40
20
20
(1) The given volumes are maximum volumes and do not denote the amount of reagent available in a specific reagent pack.
cobas c pack MULTI The cobas c pack MULTI is an empty reagent pack. These reagent packs can be used, for example, for lyophilized reagents, which have to be mixed with diluent just prior to use. To prepare a cobas c pack MULTI for use on the instrument, follow the instructions given in the Instructions for Use.
Development channel applications Development channel applications can be performed using a cobas c pack MULTI.
The reagent information, such as test name and reagent disk position, must be registered manually. On the Reagent > Setting submenu, the position of a manually registered reagent is indicated with a * symbol in the Mark column.
Note that no reagent changeover operation is performed for development channel reagents.
Barcode label Reagent packs are equipped with a barcode label. The instrument scans this label when the reagent pack is loaded at the loading port and receives the corresponding parameters from the data manager. q o If a reagent pack’s barcode is unreadable, this cobas c pack is rejected and will not be loaded but pushed out of the loading port again.
o If a reagent pack has been pushed out of the loading port, wait for 5 seconds or more before placing any further reagent pack into the port. Otherwise the system will not process the reagent pack.
o In case the parameters can not be received from the data manager, an instrument alarm is issued.
CAUTION
Incorrect results due to incorrect placement of reagent
If a reagent pack is inserted backwards, it will be rejected because the barcode cannot be read. If the wrong direction could not be detected due to a software error, reagents will be pipetted in the wrong order, leading to incorrect results.
r Always load reagent packs in the direction shown on the label near the loading port.
Roche Diagnostics
382 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module)
Reagent registration New cobas c packs are registered at the reagent pack preparation station after they have been loaded at the loading port.
u
For information on the reagent pack preparation station and the reagent pack loading port, see:
Reagent pack management system (p. 171)
If the cobas c pack currently being scanned has not been on the instrument before, the instrument proceeds with the following actions: o
By reading the reagent pack’s barcode, the instrument checks the availability of the corresponding test application.
o
The piercer punctures the reagent bottle caps.
o
An ICVC (initial cassette volume check) can be performed, but is not required for most of the Roche reagents. The reagent volume of new reagent packs is read from a file.
o
For Development Channel reagents an ICVC is performed by default. The pressure sensor at the R1 pipetter probe of the c 502 module performs the ICVC.
Remaining volume control After a cobas c pack has been registered, the instrument counts every pipetting out of this reagent pack. Thus, the reagent pack’s initial number of remaining test is counted down.
If the total number of available tests for an application on one module is lower than a defined limit, the instrument can issue an alarm. Therefore, the yellow and purple alarm levels must be set for each application under Utility > System > Reagent Level .
When the number of available tests becomes zero, a red alarm is issued and the test is masked—unless another reagent pack is available as a standby reagent or on a second module.
Unloading and reloading cobas c packs
The instrument counts down each reagent pack’s initial number of available tests with every pipetting out of that reagent pack. The number of available tests is stored by the instrument for up to 15 000 reagent packs. If you unload a cobas c pack and reload it later, the instrument recognizes the reagent pack and continues the test count at the point where the reagent pack was unloaded. It is assumed that the reagent pack’s reagent volumes remain unchanged while the reagent pack is not on the instrument.
CAUTION
Incorrect results and interruption of analysis due to false reagent volumes r Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument.
r Never load a used reagent pack onto another instrument.
u
For further instructions, see:
To unload reagent packs (p. 389)
Carryover prevention Even though all pipetter probes and reaction cells are washed and rinsed thoroughly after each use, traces of sample or reagent may remain on contacted parts (probes or reaction cells) and are carried over at the next pipetting.
By means of the special wash function, the instrument prevents traces of sample or reagent from being carried over to another test and biasing the results of the latter.
u
For more information on programming special washes, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
383
14 Reagents
Reagents (cobas c 502 module) cobas® 8000 modular analyzer series
Diluents
Reagent pack short name
NaCl
A1CD2
Table 14-22
Reagent pack long name
Comment
NaCl 9%
Hemolyzing Reagent
Gen.2
Diluents for photometric tests
Diluent for photometric tests
Diluent for HbA1c whole blood test
NaCl For photometric applications, either water or a NaCl solution is used for dilution of samples. The water is deionized water from the instrument’s water tank. NaCl solution is supplied in cobas c packs NaCl 9% .
Whenever used as diluent, the 9% solution from the cobas c pack is diluted with water to a concentration of 0.9% by the instrument.
q Make sure you have sufficient diluent on the module—especially if a higher demand of diluent can be expected.
To monitor the remaining amount of NaCl diluent, set a reagent warning level.
A1CD2 The diluent for HbA1c whole blood tests is also supplied in a cobas c pack.
Calibrators and controls
For photometric applications, universal calibrators and special calibrators are available. The same universal calibrator is used for a large number of applications whereas a special calibrator covers only a few or only one application.
Universal calibrators for photometric applications are CFAS (without diluent), CFAS
Proteins, or CFAS Proteins Urine/CSF.
Likewise, there are universal and special controls.
Universal quality controls are PNU and PPU, for example.
Usually, calibrators and controls have to be reconstituted and pipetted into cups or tubes. For measurement, place calibrators onto black calibrator racks and controls onto white QC racks.
u
For information about calibrators and quality controls for specific applications, refer to the corresponding Instructions for Use.
Roche Diagnostics
384 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module)
Auxiliary reagents (cobas c 502 module)
The c 502 module uses the following auxiliary reagents:
Product name
Cell cleaner 1
Short name
(1)
CellCln 1
Description Container type
Cell cleaner 2
Sample Cleaner 1
Sample Cleaner 2
Sample Cleaner 1
Ecotergent
CellCln 2
SmpCln 1
SmpCln 2
SmpCln 1
Ecotergent
Basic cell wash solution (NaOH-D), used for rinsing and cleaning of reaction cells
Acid cell wash solution, used for specific tests for rinsing and cleaning of reaction cells
Basic cleaning solution for sample probes
Acid cleaning solution for sample probes
1 container
1 container
1 container
1 container
For washing the sample probe, used by maintenance procedure with green wash rack
Sample tube or cup on green wash rack
Surfactant for incubator bath to prevent foaming 1 container
Position
Behind the front doors
Sample probe area
Rack Pos. 1
Ecotergent probe area
Reagent pack on reagent disk
NAOHD
SMS
SCCS
NAOHD
(D1)
Detergent 1 for reagent probe wash and cell wash
(Maintenance item (7) Wash Reaction Parts)
Table 14-23
(1) used in this documentation and the instrument software reagent pack
SMS (D2)
SCCS (D3)
Detergent 2 for reagent probe wash and cell wash reagent pack
Special cell cleaning solution. Additive, used for reaction cell carryover prevention in long HbA1c batches.
reagent pack
Auxiliary reagents on the c 502 module
Remaining volume control The instrument uses different methods to monitor the remaining volumes of the auxiliary reagents. The monitoring method used depends on the type of reagent container: o
Large containers (CellCln 1 and CellCln 2): The remaining volumes of these reagents are monitored by countdown, starting from a given initial volume.
Whenever a reagent container is replaced, the operator has to reset the initial volume. Reagent registration is not performed automatically when a new container is placed.
o
Small containers (SmpCln 1, SmpCln 2 and Ecotergent): The remaining volumes of these reagents are monitored by liquid level detection. Whenever a reagent container is replaced, the operator has to reset the initial volume. Reagent registration is not performed automatically when a new container is placed.
o
Reagent packs (NAOHD, SMS and SCCS): The remaining volumes of these reagents are monitored by countdown, starting from the time of registration. The initial volumes can not be reset.
The remaining volumes are displayed on the Reagent > Status submenu. u
For information on monitoring the reagents and resetting the initial volume, see:
Replacing auxiliary reagents (cobas c 502 module) (p. 390)
u
For information on monitoring cobas c packs, see:
Remaining volume control (p. 383)
Roche Diagnostics
Operator’s Manual · 4.2.1
385
14 Reagents
Reagents (cobas c 502 module)
Reagent Overview window (cobas c 502 module)
cobas® 8000 modular analyzer series
On the Overview menu, choose the button that symbolizes the reagent disk. The
Reagent Overview window for the selected c 502 module is displayed.
This window consists of three areas: o
Contents area: Explanation of colors used in the Reagent and the Inventory area o
Reagent area: Status of the reagent packs on the reagent disk of this module o
Inventory area: Status of the auxiliary reagents
Roche Diagnostics
386
D
E
F
A
B
C
A Inner segment: R.P. (reagent pack)
B Middle segment: Cal. (calibration)
C Outer segment: QC (Quality Control)
Figure 14-30
D
E
F
Remaining volumes of CellCln 1 / CellCln 2
Remaining volumes of SmpCln 1 / SmpCln 2
Remaining volume of Ecotergent
Reagent Overview window ( c 502 module) q A reagent mandatory message is displayed on the Reagent Overview window when the module is shown red on the Overview menu. This may occur if a reagent is not loaded or not available.
This function is available only if the test of the missing reagent has been defined as mandatory under Utility > System Configuration > Test Assignment .
Reagent area Use this area to view the status of the reagent packs loaded on the reagent disk. This area comprises a graphic representing the reagent disk.
The reagent disk is represented by a ring. The inner ring has 24 positions for reagent packs and the outer ring 36 positions; that means, 60 positions on one module.
Each reagent pack is subdivided into three segments. The colors of each segment correspond to the following statuses: o Reagent pack status (inner segment) o
Calibration status (middle segment) o QC status (outer segment)
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module)
Detailed information about a reagent pack
Choose a single reagent pack by choosing a segment. Detailed information about the reagent pack (e.g., Position , Test Name , Remaining Tests , and Calibration Date ) is displayed next to the graphic.
Figure 14-31 Detail window for a selected reagent pack
Choose the R. Pack Mask button to exclude a reagent pack from analysis temporarily.
For a detailed description of all elements on this window, please refer to the Online
Help.
Replacing reagent packs (cobas c 502 module)
The c 502 module supports loading and unloading of reagent packs by an automatic management system. A gripper transfers reagent packs from the loading port to the reagent disk. Empty reagent packs are automatically transferred to the disposal tray.
Loading reagent packs
Load all required reagent packs and auxiliary reagents as indicated on the Reagent
Load List . q Multiple reagent packs with the same reagent o More than one reagent pack can be placed in the reagent disk. When the current reagent pack is empty, the system automatically changes over to the next one (standby reagent pack).
The order of precedence of standby reagents is assessed by the time the reagent was registered; the oldest reagent is used first. The order of precedence is indicated on the
Reagent Overview window as Current (active), SB1 (first standby), SB2 (second standby), and so on.
o In case of a multi-module configuration of the same module type, the same reagent can be placed on several modules.
Roche Diagnostics
Operator’s Manual · 4.2.1
387
14 Reagents
Reagents (cobas c 502 module) cobas® 8000 modular analyzer series
Before performing the following actions, observe these safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Incorrect results due to expired reagents or mixing reagents (p. 230)
r
Incorrect results due to wrong temperature of the incubator (p. 232)
p To load a cobas c pack
1
Open the reagent pack table at the front of the c 502 module downward to access the reagent pack loading port.
A
CAUTION
A Barcode label
Figure 14-32 Loading a cobas c pack into the c 502 module
2
Place the cobas c pack right in front of the loading port with its barcode label facing to the right .
Injury due to contact with reagent pack loading mechanism
The instrument may recognize your hands or fingers as a reagent pack if you insert your hands or fingers into the loading port. An unloaded reagent pack may hit your hands or fingers when the instrument is unloading reagent packs. r The top cover must be closed and locked when loading reagent packs.
r Leave the reagent pack table closed, except when registering reagent packs or when manually unloading reagent packs from the Reagent > Setting submenu.
r If a reagent pack barcode is facing the wrong direction or the barcode is unreadable, a label reading error occurs and the reagent pack is not registered. In this case the reagent pack is rejected and will not be loaded but pushed out of the loading port.
3 Slide the cobas c pack all the way into the loading port until you sense a resistance.
From this point on the instrument handles the cobas c pack without any further intervention of the operator: The cobas c pack is pulled in to the preparation station where the module automatically performs the reagent registration.
s
Roche Diagnostics
388 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module)
Unloading and reloading reagents
Unloading reagents The c 502 module supports two unloading options: o
Dump option: Sends an empty reagent pack to the disposal.
o
Unload option: Sends a partly filled reagent pack to the loading tray (required if a pack should be reloaded).
Reloading reagents Already used cobas c packs can be unloaded and stored according to the storage conditions (see Instructions for Use).
A used cobas c pack can be reloaded onto another module within the same cobas 8000 instrument.
CAUTION
Incorrect results due to reloading of reagent packs r Never load a used reagent pack onto another cobas 8000 instrument; otherwise information about reagent volume and on-board stability are missing, which may lead to incorrect results.
r Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument.
r Never refill a reagent pack. Discard empty reagent packs.
p To unload reagent packs
1 Make sure that the instrument is in Standby.
2 Choose Reagent > Setting .
3 Select a c 502 module from the Module list.
4 Select the position of the cobas c pack that is to be unloaded.
The line is highlighted in gray.
5 Choose R. Pack Unloading to open the Unloading window.
6 Choose Unload to send the cobas c pack to the reagent pack loading port.
OR: Choose Dump to send the cobas c pack to the reagent pack disposal.
q If you use the Dump option, the unloaded cobas c pack cannot be reloaded.
7 Choose Execute .
If you chose the Unload option, wait at least 5 seconds after the reagent pack was pushed out of the loading port before you place any reagent pack into the port.
s
Registering reagents manually (Development Channel)
Development Channel applications must be registered manually on the module.
Since the same development channel barcode is used for all development channel applications, the cobas c pack MULTI has to be assigned to a development channel application before loading onto the analyzer.
q A description for loading Development Channel applications is available on the cobas e-library. Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche representative for more information.
Roche Diagnostics
Operator’s Manual · 4.2.1
389
14 Reagents
Reagents (cobas c 502 module) cobas® 8000 modular analyzer series p To register a cobas c pack manually on a c 502 module
1 Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2 Prepare the reagent in a cobas c pack MULTI (see Instructions for Use).
3 Check that there is no foam inside the bottles of the cobas c pack MULTI.
4 Choose Reagent > Setting > Manual Registration .
5 Select the Test Name and Type of the reagent and choose OK .
6 Load the cobas c pack MULTI in the same way as ready-to-use reagent packs. u
See
To load a cobas c pack (p. 388)
7 On the Reagent > Setting submenu, check that Available Tests , Type , Lot ID , and Exp. Date are appropriate.
s
Replacing auxiliary reagents (cobas c 502 module)
Replacing a container and resetting the reagent volume
When replacing auxiliary reagent containers (such as cell detergent or sample probe detergent containers), you must manually reset the reagent volume count.
CAUTION
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. r
Observe in particular the following safety label on the instrument: F-5 (p. 41).
CAUTION
CAUTION
Improper aspiration of detergent due to foam or air bubbles
If you shake the new detergent container before placing it on the instrument, the detergent may form foam or air bubbles.
r Do not shake the detergent containers before placing them on the instrument.
Incorrect results due to errors when replacing auxiliary reagents
The detergent volume is monitored by counting down from the initial volume. If the volume counter is not reset correctly, this may cause detergent shortage, leading to incorrect results.
r Ensure to reset the volume counter after the replacement of a container.
r Always replace empty containers with new and full ones.
r Only reset the volume counter after a new container has been placed.
Follow the procedures below to replace detergent containers: p To replace a c 502 cell detergent container
1 Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
Roche Diagnostics
390 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
2 Open the front door of the module.
14 Reagents
Reagents (cobas c 502 module)
CAUTION
A B
A CellCln 1
Figure 14-33
B CellCln 2
Replacing the cell detergents
3 Take out the empty detergent container and remove the aspiration tube.
4 Check the aspiration filter at the end of the tube. Clean it if required.
u
See:
To clean the detergent aspiration filters (p. 725)
5 Insert the tube into the new container.
Incorrect results due to incorrect insertion of aspiration tube
If the aspiration tube is not inserted correctly, the detergent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube so that the end of the tube touches the bottom of the container. r Do not bend the aspiration tube.
6 Replace the container and close the front door.
7 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s p To replace a c 502 sample probe detergent container
1
Make sure that the instrument is in Standby.
2
Open the top cover of the module.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
Roche Diagnostics
Operator’s Manual · 4.2.1
391
14 Reagents
Reagents (cobas c 502 module) cobas® 8000 modular analyzer series
CAUTION
A
A Position 1 = SmpCln 1 (basic wash)
B Position 2 = SmpCln 2 (acid wash)
Figure 14-34 Sample probe cleaners
3 Replace the required detergent container.
B
Incorrect results due to carryover caused by detergent shortage
If the remaining volume counter is not reset after replacement, a detergent shortage may potentially go undetected, leading to sample carryover.
r Always reset the remaining volume after replacement of a sample probe cleaner.
r Do not replenish detergent bottles.
4 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s
Roche Diagnostics
392 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas c 502 module) p To replace the Ecotergent container
1 Make sure that the instrument is in Standby.
2 Open the top cover of the module.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
A
A Ecotergent container
Figure 14-35 Detergent for the incubator bath
3 Replace the Ecotergent container.
4 Reset the volume counter of the replaced detergent. Choose Reset from the
Reagent Overview window, or Reagent Volume Reset from the Reagent menu. s
Roche Diagnostics
Operator’s Manual · 4.2.1
393
14 Reagents
Reagents (cobas e 602 module)
Reagents (cobas e 602 module)
cobas® 8000 modular analyzer series
This section provides information about all reagents used on the e 602 module, including auxiliary reagents, calibrators, and controls. It also describes the reagent containers used on this module.
Reagent concept (cobas e 602 module)
This section describes all reagents necessary to run the module and the reagents that are specific for each available e 602 application. The available applications are divided into different groups:
Parameter group Parameter group
Anemia
Bone marker
Cardiac marker
Maternal care
Rheumatoid arthritis
Thyroid function
Critical care
Fertility / hormones
TORCH
Tumor markers
Infectious diseases
Table 14-24
Others
Parameter overview of the e 602 module
Reagent packs – cobas e packs
The principal reagent container for e 602 modules is the cobas e pack.
Roche Diagnostics
394
A B
A Reagent 2 (R2)
B Reagent 1 (R1)
Figure 14-36
C cobas e pack with assay reagent
Microbeads
C
A cobas e pack consists of one to three separate, capped reagent containers. For each e 602 application, there is an individual cobas e pack available.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Types of reagent The following types of reagent are available for the e 602 module. All of them are provided in cobas e packs.
Reagent type Configuration of cobas e pack
Assay 3 reagent containers
Diluent
Pretreatment (sample pretreatment used for specific immunoassays)
Table 14-25
1 or 2 reagent containers
1 or 2 reagent containers
Types of reagent in cobas e packs
Soft-close position of reagent caps The e 602 modules are equipped with an open/close mechanism for the caps of the reagent packs. The mechanism is able to open and close the caps automatically if the caps are in the soft-close position : The caps are almost closed, but not tightly closed.
A B C
A Closed cobas e pack
B Opened cobas e pack
Figure 14-37
C Caps in the soft-close position
Soft-close position of reagent caps
In this position, the caps can be opened by the mechanism. At the same time, evaporation of reagent is prevented.
Reagent registration Each cobas e pack is labeled with two matrix barcodes. When the user closes the reagent disk cover, the instrument registers new cobas e packs automatically. The barcode reader scans only the barcodes facing the center of the reagent disk, the other barcode is used by other analyzers. Then the instrument receives the corresponding parameters from the data manager.
q If a barcode is unreadable, an instrument alarm is issued. The position of the unidentified reagent pack is indicated on the Reagent Overview screen.
In this case, please check that the corresponding application was downloaded before.
Then unload the reagent pack and check if the barcode label is dirty or scratched. A manual registration of cobas e packs is not possible.
Roche Diagnostics
Operator’s Manual · 4.2.1
395
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
Priority of cobas e packs If there are multiple reagent packs for one application on an e 602 module, these reagents are used up in the following order:
1. Current reagent pack
2. Reagent pack with the same lot number as the last used reagent pack
3. Reagent pack of lot that expires first
4. Within the same lot: The reagent pack with the oldest registration date
5. Within the same lot: Reagent pack with the least remaining volume
6. Within the same lot: Reagent pack in the lowest position
Generally speaking that is, the older reagent takes precedence over the newer one.
Remaining volume control After a cobas e pack has been registered, the instrument counts every pipetting out of this reagent pack. Thus, the reagent pack’s initial number of remaining tests is counted down. An LLD check (liquid level detection) is performed additionally, but the system does not update the remaining volumes with LLD check results.
If the total number of available tests for an application on one module is lower than a defined limit, the instrument can issue an alarm. Therefore, the yellow and purple alarm levels must be set for each application under Utility > System > Reagent Level .
When the number of available tests becomes zero, a red alarm is issued and the test is masked—unless another reagent pack is available as a standby reagent or on a second module.
Carryover prevention Heterogeneous immunoassays are very sensitive tests. Some combinations of these assays are especially sensitive against carryover. To prevent such carryover, special wash programs are required on Utility > Special Wash .
The special washes recommended for the installed applications can be downloaded from the data manager.
u
For more information, see Programming a special wash (cobas e 602 module) (p. 570).
Diluents
Diluents for immunoassays are provided in cobas e packs with one or two reagent containers.
Dilution of samples is necessary when the analyte concentrations exceed the measuring range of the respective immunological test method. In addition, general predilution of samples is specified for some immunological tests.
Examples of diluents are: o
Diluent Universal o
Diluent MultiAssay u
For information on required diluents and recommended dilution factors, refer to the
Instructions for Use of the respective application.
Roche Diagnostics
396 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Pretreatment reagents and the PT link function
Measurement of certain analytes require dissociation from binding proteins.
Therefore, some immunoassays use a pretreatment procedure to prepare the sample for measurement. The pretreatment reagent is provided in cobas e packs with one or two reagent containers.
After registration, a pretreatment reagent pack always forms a pair with an assay reagent pack of the same test and the same lot. This function is called PT link . The linkage is required for reasons of stability. For example, the linkage ensures that the standby pretreatment reagent pack is used for the corresponding standby reagent pack.
A B
A Assay reagent pack
Figure 14-38
B Pretreatment reagent pack
Assay reagent linked with pretreatment reagent
PT link basics o
Once an assay reagent pack and a pretreatment reagent pack are linked together, neither can be linked to another reagent pack.
o
The lower number of remaining tests in one of the linked reagent packs determines the number of available tests. A liquid level detection is performed during aspiration of pretreatment.
o
If one reagent pack in the pair becomes empty, the remaining number of tests for the linked reagent pack is set to 0. Both reagent packs cannot be used anymore.
Roche Diagnostics
Operator’s Manual · 4.2.1
397
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
Link statuses Both reagent packs can have one of the following link statuses:
Link Status
Free
Explanation
The reagent is not yet linked to any other reagent pack. Free reagent is not available for measurement.
Linked The reagent is available for use.
Empty Both or one of the linked reagents is empty.
Reagents that are not linked have become empty for some reason.
Table 14-26 Explanation of the link statuses q Reagent packs already used before a software update
After updating to the current software version with the PT link function, some reagent packs may still have the Link Status Free even though they have been used. The PT link function will be used for the next fresh reagent packs.
Linking rules and timing The instrument registers cobas e packs automatically when the reagent disk cover is closed. If the instrument recognizes an assay reagent pack with the Link Status Free , the instrument tries to find a pretreatment reagent pack available for linking. This pack must fulfill the following conditions: o
The lot number and ACN are identical with those of the assay reagent pack.
o
The pretreatment reagent pack has the status Free .
The linkage is stored at the registration time of the assay reagent pack and/or the pretreatment reagent pack.
Roche Diagnostics
398 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Figure 14-39 Detail window for a selected pretreatment reagent pack (left) and the linked assay reagent pack (right)
Calibrators and controls
There are specific calibrators for each e 602 application. As for quality controls, there are controls covering multiple applications and controls that are specific for only a single application.
u
For information on required calibrators and controls, refer to the Instructions for Use for the corresponding assay reagent.
To obtain information about the calibrators and controls currently needed for calibration or QC, print a Calibration and QC Load List from the software.
u
For information on how to print a Calibration and QC Load List
, see Performing calibration and QC (p. 280).
Inpack calibrators Some applications use inpack calibrators. Inpack calibrators are calibrators which are delivered within the reagent package.
u
For details, see
Routine calibrators and inpack calibrators (p. 446).
Auxiliary reagents (cobas e 602 module)
The e 602 module uses the following auxiliary reagents:
Roche Diagnostics
Operator’s Manual · 4.2.1
399
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
Product name
ProCell (PC)
CleanCell (CC)
PreClean
ProbeWash
SysClean
Table 14-27
Description o o o
Conditioning of the electrodes
Transport of the assay reaction mixture o
Washing of the streptavidin-coated microbeads
Signal generation o o o
Cleaning of tubing system and measuring cell after every measurement o
Conditioning of the electrodes
To remove potentially interfering substances before signal generation—the final step of the analytical procedure.
Required only for certain assays. Its use is indicated under
Materials required (but not provided) in the Instructions for
Use for the respective assay reagent.
o
Cleaning solution for the reagent probes to prevent carryover
(special washes) o
Sodium hypochlorite solution used for cleaning of the measuring cells (every two weeks).
Auxiliary reagents on the e 602 module
Container type
2 containers
2 containers
2 containers
2 containers
Position
Behind the middle front door
At the inside of the front door
Near the reagent probe
Not on the instrument
Roche Diagnostics
400 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Reagent Overview window (cobas e 602 module)
On the Overview menu, choose the button that symbolizes the e 602 module. The
Reagent Overview window is displayed for the selected e 602 module.
This window consists of three areas: o
Contents area: Explanation of colors used in the Reagent and the Inventory areas o
Reagent area: Status of the e 602 reagents o
Inventory area: Status of auxiliary reagents, consumables and waste
Roche Diagnostics
Operator’s Manual · 4.2.1
D
E
A
B
C
F
A
B
C
Inner segment: R.P. (reagent pack)
Middle segment: Cal. (calibration)
Outer segment: QC (Quality Control)
Figure 14-40
D Remaining volumes of ProCell 1/2
E Remaining volumes of CleanCell 1/2
F Solid waste containers 1/2 for
AssayCups/AssayTips
Reagent Overview window ( e 602 module) q A reagent mandatory message is displayed on the Reagent Overview window when the module is shown red on the Overview menu. This may occur if a reagent is not loaded or not available.
This function is available only if the test of the missing reagent has been defined as mandatory under the Utility > System Configuration > Test Assignment .
Reagent area Use this area to view the status of the reagent packs loaded on the reagent disk. This area comprises a graphic representing the reagent disk by a ring with 25 positions for reagent packs.
Each reagent pack is subdivided into three main segments. The middle and outer segments are subdivided in two subsections corresponding to the two measuring channels. The colors of each segment correspond to the following statuses: o Reagent pack status (inner segment) o
Calibration status (middle segment) o QC status (outer segment)
401
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
Inventory area ( e 602) The Inventory area displays the amount of auxiliary reagents, magazines, magazine waste and solid waste on the selected module. The abbreviations have the following meaning: o
PC1/PC2: ProCell bottles 1 and 2 o
CC1/CC2: CleanCell bottles 1 and 2
Magazine Magazine Waste Waste
Each green segment of the bar represents:
One full magazine The place for one empty magazine
The cups/tips from one magazine
Example: The number 7 indicates that …
… 7 full magazines are onboard.
… there is space for
7 additional empty magazines
(5 magazines are already in the compartment).
Table 14-28 Explanation of bar charts
… 7 additional magazines can be exchanged before the
WasteLiner is full.
Inventory Update Use the Inventory Update button to execute an inventory update for an e 602 module. This button is a short cut to the Inventory Update maintenance window.
These are the steps of an inventory update: o
Update the number of magazines in the magazine lifter o
Update the number of AssayCups and AssayTips. The instrument discards all cups and tips from the current magazine and then lifts a full magazine to the top.
o
Check and update of ProbeWash solutions 1 & 2
Detailed information about a reagent pack
Choose a single reagent pack by choosing a segment. Detailed information about the reagent pack (e.g., Position , Test Name , Remaining Tests , Calibration Date , …) is displayed next to the graphic.
Roche Diagnostics
402
Figure 14-41 Detail window for a selected assay reagent pack
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Choose the R. Pack Mask button to exclude a reagent pack from analysis temporarily.
For a detailed description of all elements on this window, please refer to the Online
Help.
Replacing reagent packs (cobas e 602 module)
Replacing cobas e packs Replace all required cobas e packs, auxiliary reagents, and consumables as indicated on the Reagent Load/Unload List . Ensure that cobas e packs have not exceeded their expiration date.
CAUTION
Incorrect results due to incorrect reagent temperature
The cobas e packs taken directly from the refrigerator may cause incorrect results.
r Only insert cobas e packs of the correct temperature of 20 ±3 °C (68 ±5.4 °F).
CAUTION p To replace cobas e packs
1 Make sure that the instrument is in Standby.
Or: Mask the module to replace reagents during operation ( Start > Masking
> Module Masking ) and wait until the module is in Standby.
2 Print a Reagent Load/Unload List (or choose Overview > Reagent Overview ) to check for any empty cobas e packs.
Risk of personal injury and damage to the instrument
If you open the reagent disk cover during operation, your fingers may damage moving parts or get entangled in the reagent disk, causing injury. The complete system would also be interrupted by a yellow alarm.
r Never open the reagent disk cover while the module is operating. Otherwise the whole system would be stopped.
r Ensure the module has reached Standby mode. Then mask the module and open the cover.
3 Lift off the reagent disk cover.
Roche Diagnostics
Operator’s Manual · 4.2.1
403
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
4 Open the caps of each reagent pack manually and set the caps gently to the softclose position : The caps are almost closed, but not tightly closed.
Figure 14-42 Placing cobas e packs
5
Place the required reagents in the reagent disk. Ensure that the cobas e packs are placed in the reagent disk with the correct orientation.
6
Close the cover of the reagent disk. A reagent scan is activated and the Reagent
Overview window is updated.
s
Replacing auxiliary reagents (cobas e 602 module)
Green buttons Green illuminated push buttons indicate the status of the ProCell/CleanCell and
PreClean bottles. The green buttons indicate when it is safe for you to replace a reagent bottle:
OFF
ON
Flashing
The bottle is in use, do not replace it.
This is a standby bottle, do not replace it.
The bottle is empty, it is safe to replace it.
(When air bubbles are detected, this button also flashes.)
Roche Diagnostics
404 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
A
14 Reagents
Reagents (cobas e 602 module)
CAUTION
CAUTION
B C D
A Green buttons for ProCell and CleanCell
B PreClean bottles
C ProCell bottles (in keyed positions)
D CleanCell bottles (in keyed positions)
Figure 14-43 Green buttons near the auxiliary reagent bottles u
For information on the auxiliary reagents used on e 602 modules, see:
Auxiliary reagents (cobas e 602 module) (p. 399).
Before performing the following actions, observe these safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Incorrect results due to expired reagents or mixing reagents (p. 230)
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. r
Observe in particular the following safety label on the instrument: F-5 (p. 42).
Malfunction of instrument and incorrect results
If you press a green button without replacing the corresponding bottle, the volume available for pipetting may be less than expected by the system and therefore cause deterioration in measurement accuracy. An instrument alarm will be issued (reagent short) and the results will be marked with data alarms.
r Only replace a bottle when the green button is flashing. r Only press a green button when the corresponding bottle was replaced.
r
Observe in particular the following safety label on the instrument: F-15 (p. 43).
Roche Diagnostics
Operator’s Manual · 4.2.1
405
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
Replacing ProCell and CleanCell (cobas e 602 module)
Two bottles of ProCell and two bottles of CleanCell are located behind the middle front door of the module. Whenever you place a new bottle of ProCell of a new lot, enter its lot number according to the following procedure. This ensures the traceability of the used lot.
q If both bottles of ProCell, CleanCell or PreClean solution are empty, or if the
AssayCups/AssayTips magazines are empty on a e 602 module, the corresponding module turns red on the Overview menu and is not used for sample processing. If your cobas 8000 system is equipped with another e 602 module, sample processing is performed on the second module.
u
For information on the location of the reagents on the module, see:
Auxiliary reagents and cleaning solutions (p. 202).
p To replace ProCell (PC)/CleanCell (CC)
1 Open the middle door of the e 602.
q Only replace a bottle if the green button is flashing.
A
B
C
A Notch
Figure 14-44
B Aspiration tube C Filter
Replacing a ProCell/CleanCell bottle
2
Pull the aspiration tube (
B ) up and to the left to secure it on the notch ( A
).
3
Absorb liquid from the filter (
C ) with lint-free gauze pads.
Roche Diagnostics
406 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
CAUTION
CAUTION
Replacing PreClean bottles
4 Remove the empty bottle, indicated by the flashing green button.
Incorrect results due to misplaced ProCell/CleanCell bottles
ProCell and CleanCell bottles are different in shape to fit the keyed position of the bottle stand. This is done to ensure the correct positions. Measurements cannot be performed if the bottle stand is not present.
r Ensure the bottle stand is present before placing the ProCell and CleanCell bottles.
r To prevent evaporation, check that each bottle is closed correctly by the slider cap.
r Observe in particular the following safety label on the instrument:
5
Replace the bottle with a new one ensuring that it is firmly in place. Remove the cap.
False results due to loose PC/CC aspiration tube filters r Lower the aspiration tube slowly into the bottle. Do not let it drop into the bottle.
q
6
Lower the aspiration tube into the new bottle. Ensure that the bottle is closed by the slider cap.
Only press the green button after you have replaced a bottle. Do not press the green button under any other circumstances.
7
Press the flashing green button corresponding to the position in which the new bottle has been placed to inform the system that a new bottle was loaded. The button will be illuminated indicating that this is a standby bottle.
8
Close the middle door of the e 602 module.
9
If a ProCell bottle with a new lot number was loaded, enter the lot number via
Reagent > Status . This requires the complete instrument to be in Standby.
o
Select the desired e 602 module from the list box.
o
Choose Inventory Setting to open the Inventory Set window.
o
Type the new lot number into the box for ProCell Position 1 or 2, respectively.
o
Choose OK .
s
CAUTION
Two bottles of PreClean are located on the inner side of the front door of the module.
u
To locate PreClean bottles, see:
Auxiliary reagents and cleaning solutions (p. 202).
Personal injury due to contact with PreClean needles
Contact with the PreClean needles may cause personal injury. r Do not put your hands into the PreClean bottle holder.
r Do not replace a bottle if the green button is not flashing.
r
Observe in particular the following safety label on the instrument: F-16 (p. 43).
Roche Diagnostics
Operator’s Manual · 4.2.1
407
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series p To replace PreClean
1 Open the middle door at the front of the required module.
2 Remove the empty bottle, indicated by the flashing green button.
CAUTION
Figure 14-45 Placing a PreClean bottle
3
Place a full PreClean bottle into the bottle holder. Ensure the new bottle is firmly in place and that the needle has pierced the bottle.
Incorrect results due to misplaced PreClean bottles
If you do not properly load the PreClean bottles or load them without checking, the volume available for pipetting may be less than expected by the system and therefore cause deterioration in measurement accuracy.
r
Observe in particular the following safety labels on the instrument: F-15 (p. 43),
q
4 Loosen the cap to allow air into the PreClean bottle.
5 Press the flashing green button corresponding to the position where the new bottle has been placed to inform the system that a new bottle has been loaded. The button will be illuminated indicating that this is a standby bottle.
o Only press the green button after you have replaced a bottle. Do not press the green button under any other circumstances. o Press the green button during Standby.
o When the button has been pressed but it continues to flash, the PreClean bottle was detected as empty by the LSS. The button will not be able to be used to update the reagent inventory until the module is in Standby.
6 Close the middle door of the e 602.
s
Roche Diagnostics
408 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module)
Replacing ProbeWash bottles
Two bottles of ProbeWash are located on the analytical module near the reagent probe.
u
To locate ProbeWash bottles, see:
The two ProbeWash bottles can simply be replaced when necessary, as the reagent probe is equipped with a liquid level detector (LLD) which senses the remaining volume.
p To replace ProbeWash
1
Remove the empty ProbeWash bottle.
2
Remove the cap from the new ProbeWash bottle.
3
Place the new ProbeWash bottle in the module.
The level is checked and the inventory is automatically updated.
q ProbeWash can only be replaced when the complete instrument is in Standby or if the affected module is masked and in Standby.
s
Replacing consumables and emptying solid waste (cobas e 602 module)
All consumables (AssayCups and AssayTips) and solid waste are located in the magazine drawer. o
The lifter can be loaded with new AssayCup and AssayTip magazines.
o
The magazine waste compartment contains the empty magazines.
o
The solid waste compartment has solid waste containers for used AssayCups and
AssayTips.
u
See Consumables components (p. 203)
Roche Diagnostics
Operator’s Manual · 4.2.1
409
14 Reagents
Reagents (cobas e 602 module)
A cobas® 8000 modular analyzer series
B C
NOTICE
A Status lamp of drawer
B Handle of the magazine drawer
Figure 14-46 Opening the magazine drawer
C Green buttons for waste containers
The green status lamp at the top of the magazine drawer indicates when the magazine drawer and door can be opened. In addition, two green buttons to the right of the magazine lifter indicate the status of the waste containers.
Off
On
Flashing
Table 14-29
(magazine drawer)
(waste container)
Operating
DO NOT open
Drawer safe to open
Waste container in use
DO NOT replace it.
Standby container (empty)
DO NOT replace it.
About to operate
DO NOT open
Container full, safe to replace it.
Empty it immediately
Status indicators at the magazine drawer and waste containers
Damage to the instrument
Excessive weight on the magazine drawer of the e 602 may lead to damage.
r Do not open the front door of the magazine drawer and do not pull out the magazine drawer when the green status lamp is off or blinking.
r Pull out the magazine drawer gently and do not lean on the magazine drawer.
Roche Diagnostics
410 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 14 Reagents
Reagents (cobas e 602 module) p To replace AssayCup and AssayTip magazines
1
Make sure the green status lamp (figure 14-46, p. 410, A ) at the top of the drawer
is ON, then pull out the drawer all the way.
q
A B
A Magazine waste
Figure 14-47 Replacing magazines
B Full magazines in the lifter
2 Empty the magazine waste.
3 Close the drawer, ensuring that it is fully closed.
4 Open the front door and refill the magazine lifter.
5 The level is checked and the inventory is automatically updated the next time the instrument changes the magazine.
Ensure that the door at the front of the drawer is closed. Otherwise, the magazine lifter will detect the open door the next time it operates and the instrument will stop.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
411
14 Reagents
Reagents (cobas e 602 module) cobas® 8000 modular analyzer series
WARNING p To empty solid waste
Infection from waste solution and solid waste
Since waste solution contains patient samples, contact with waste solution and solid waste
(e.g., AssayCups, AssayTips) may result in infection. r Be sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut which can lead to infection. r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
r Observe in particular the following safety labels on the instrument:
1
Make sure the green status lamp (figure 14-46, p. 410, A ) at the top of the drawer
is ON, then pull out the drawer all the way.
2
Remove the waste container liners and replace with fresh ones as required.
3
Close the drawer, ensuring that it is fully closed.
4
Open the transparent panel at the front of the drawer.
A
B
Roche Diagnostics
412
A Position 1 = Green button for left WasteLiner
B Position 2 = Green button for right WasteLiner
Figure 14-48 Updating the inventory after replacement q Only press the green button after you have replaced a bottle. Do not press the green button under any other circumstances
5 Press the flashing green button corresponding to the container(s) emptied.
6 Close the door ensuring that it is fully closed.
q Ensure that the door at the front of the drawer is closed. Otherwise, the magazine lifter will detect the open door the next time it operates and the instrument will stop.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Calibration
15 Calibration
15
This chapter describes certain tasks associated with the Calibration menu as well as special tasks that are not usually part of the daily workflow.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
15
Requesting calibrations from the Calibration > Status submenu ................... 423
Requesting and cancelling calibrations manually............................................. 423
Checking information about already installed calibrators .............................. 429
413
15 Calibration
Table of contents cobas® 8000 modular analyzer series
Reviewing calibration data (photometric modules)............................................... 440
Roche Diagnostics
414 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (overall system)
Calibration (overall system)
Chapter structure This chapter is separated into a module-independent section (overall system) and a section for each module. The general section contains an introduction and describes the menus of the instrument software that are used for calibration management.
The sections referring to each module contain information on the calibration concept used on this module and how to review calibration results.
Introduction
The following section gives an overview of the calibration concept applied by the cobas 8000 system; it provides you with a basic understanding of the various calibration functionalities implemented on the instrument and its software.
u
For instructions on how to perform calibrations, see
u
For more information about what calibration is, please refer to the COBI CD .
Usage recommendations for calibration
The relation between measurement values and results is subject to various environmental and reagent conditions and may drift over the course of time.
Therefore it is necessary to repeat calibrations regularly. To keep the resulting calibration management simple and efficient the instrument automatically recommends calibrations.
$XWRPDWLFFDOLEUDWLRQ 0DQXDOFDOLEUDWLRQ
5HFRPPHQGHGFDOLEUDWLRQV 6WDUWXSFDOLEUDWLRQ
&DXVH
‡0DQXDO
&DXVHV
‡&KDQJHRYHU
‡7LPHRXW
‡&DOLE1RZ
‡)DLOHG
‡4&9LRODWLRQSURYLGHGE\
GDWDPDQDJHU
Figure 15-1 Automatic or manual calibration
,QGLYLGXDOFDOLEUDWLRQ
&DXVH
‡0DQXDO
Automatic calibrations
Roche Diagnostics
Operator’s Manual · 4.2.1
The cobas 8000 instrument automatically recommends calibrations for the following causes: o
Change of reagent pack or reagent lot (Changeover):
o
After time intervals:
O
Calibration at regular intervals (Timeout)
O
Calibration in combination with Preventive action
o
When a calibration failed (Failed)
415
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series
Changeover Changeover calibrations have to be performed when certain physical events occur.
These include: o
A change in reagent lot (of cobas c packs or cobas e packs) o
A change in a reagent pack (regardless of the lot) o
The installation of a new test on the system
Most of the photometric tests need to be calibrated only when the reagent lot is changed (lot calibration). Some of the tests, however, need to be calibrated whenever a new reagent pack is inserted; the instrument requests a changeover calibration.
Some immunoassays must also be calibrated after replacement of a reagent pack. A lot changeover calibration cannot be programmed.
Timeout Calibrations are performed at regular intervals to compensate for changes over time in reagents and in the measurement systems. Timeout calibrations can be performed for Lot timeout and for R. Pack timeout.
Calib Now This automatic calibration function is active only if Preventive Action is activated
(select the check box in the Overview menu). When a calibration times out during a period specified in the Remaining Time box on the Calibration > Status submenu, the instrument recommends a calibration indicating Calib Now as calibration cause.
Failed When a calibration fails one or more quality criteria, this calibration gets the status
Failed . The instrument automatically recommends a recalibration.
QC Violation QC Violation is provided by the data manager. It is a QC-triggered calibration. A calibration will be ordered, if the QC results are outside of the limits defined on the data manager.
q Recommended calibrations do not start automatically. To start the calibration, you have to request the recommended calibrations.
u
For information on QC-triggered calibrations, please refer to the data manager component Calibration recommendations in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
Manual calibrations
Manual is displayed in the Cause column on the Calibration > Status submenu if: o
a predefined set of tests is selected ( Start-up calibration (p. 416))
o individual tests for calibration are manually selected (
Start-up calibration This function allows you to select a predefined set of tests which are calibrated when you order a start-up calibration. To order a start-up calibration, select the Start Up button on the Calibration and QC select window or on the Calibration > Status submenu. The tests for start-up calibration are defined on Calibration > Status
> Start Up Setting .
For start-up calibrations, Manual is displayed in the Cause column on Calibration
> Status .
u
See Selecting tests for start-up calibrations (p. 425).
Roche Diagnostics
416 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (overall system)
Individual calibration This function allows you to measure calibrations of any tests based on your judgment. On the Calibration > Status submenu you may manually select individual tests for calibration. To request an individual calibration, select the Save button on the Calibration > Status submenu.
For individual calibrations Manual is displayed in the Cause column on Calibration
> Status .
u
For more information, see Requesting and cancelling calibrations manually (p. 423).
Validation of calibration
After a calibration is performed, it needs to be validated. The instrument performs this task by means of automatic calibration checks. When a calibration is successful, the calibration data are available for the measurement of patient samples and controls. Whenever the instrument detects an irregular condition or result, the calibration is classified as failed, a calibration alarm is issued, and the calibration is recommended to be repeated.
Calibration masking (auto masking)
The Auto Masking function masks a test if no valid calibration is available for the corresponding reagent pack. The test can be masked separately for each particular module ( c 502), reagent disk ( c 701 / c 702), or measuring channel ( e 602).
There are two cases where no valid calibration is available: o
Failed calibrations o
Invalid calibrations (in case of a changeover calibration request)
The Auto Masking function can be activated or deactivated for the entire system under Utility > System > Calib. and QC Settings . When activated, the function can be selected individually for each application on Utility > Application > Calib .
u
For information about the settings, see:
Calibration Settings (Auto. Masking) (p. 525)
Calibration masking (application-specific) (p. 555)
Failed calibrations When a calibration fails one or more quality criteria, this calibration receives the status Failed . The instrument automatically recommends a recalibration.
o
If automatic calibration masking is activated, the corresponding test with the
Failed calibration data is masked. No more patient samples and controls will be measured for this test.
o
If automatic calibration masking is not activated, the test is not masked, but data alarms are attached to the results.
The Failed calibration can be rejected by the operator ( Reject button on Calibration
> Status ) so that the latest successful calibration, if it exists, is used for the samples and controls. If a failed calibration is rejected, no calibration request remains for the reagent pack.
Roche Diagnostics
Operator’s Manual · 4.2.1
417
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series
Invalid calibrations If a test requires to be calibrated after replacement of a reagent pack, the instrument requests a changeover calibration for this reagent pack. This can be defined on Utility
> Application > Calib.
by the R. Pack check box in the Changeover area.
A changeover calibration request means that the existing calibration data could not be transferred to the new reagent pack. The new reagent pack has an Invalid calibration until the calibration is performed.
o
If automatic calibration masking is activated, the corresponding test with the
Invalid calibration data is masked. No more patient samples and controls will be measured for this test.
o
If automatic calibration masking is not activated, the test is not masked but the
Cal.I alarm (Calibration result invalid) is attached to the results. The results are calculated with the invalid transferred calibration data.
An invalid calibration cannot be rejected by the operator because there is no valid calibration available.
Containers and racks for calibrators
All calibrators must be loaded in black calibrator racks only.
u
For information on container types applicable for calibrators, see:
Rack classes and colors of standard racks (p. 93)
Which container for which application?
Calibrators with or without barcodes
CAUTION
When working with barcodes, calibrators are automatically identified. In case calibrators are processed without barcode, it is necessary to assign a rack number and rack position for each calibrator.
The current rack assignment is listed on the Calibration > Calibrators submenu. To provide additional assignments or remove existing assignments, choose Rack Assign .
Incorrect results due to position mismatch
A misplacement of assigned calibrators (without barcode) would go undetected by the system and yield completely invalid results.
r Be sure to use the specified racks and positions, for assigned calibrators (without barcode).
q Do not use barcoded calibrators on a calibration rack that is assigned for non-barcoded calibrators.
u
For more information, see:
Assigning calibrator positions (p. 426).
Roche Diagnostics
418 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Menu summary
Submenu
Overview menu
15 Calibration
Calibration (overall system)
The following sections describe how calibration is managed with the cobas 8000 instrument software.
Function
The Overview menu supports the calibration management in the following way:
The Calib. and QC Select button provides direct access to important functions on managing calibrations: The button enables requesting tests for calibration and printing of a
Calibrator Load List .
u
See
Calibration > Status submenu
The Calibration > Status submenu is used to perform the following: o
To view detailed information about the calibration status of the tests on the modules selected in the Module list box o
To select tests for start-up, timeout, changeover or manual calibrations o
To view existing calibration data u
See
Table 15-1 Menu overview
Roche Diagnostics
Operator’s Manual · 4.2.1
419
15 Calibration
Calibration (overall system)
Submenu
Calibration > Calibrators submenu cobas® 8000 modular analyzer series
Function
The Calibration > Calibrators submenu is used to perform the following: o o
To review information about already registered calibrators
To assign calibrators to specific racks and positions u
See
Calibration > Install submenu
The Calibration > Install submenu is used to perform the following: o
To review information about already registered calibrators o
To update calibrator information o
To install new calibrators u
See
Table 15-1 Menu overview
Roche Diagnostics
420 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview menu
15 Calibration
Calibration (overall system)
The following section explains calibration tasks associated with the Overview menu.
Choose the Overview button in the menu line, or press the F12 key to display the
Overview menu.
Calibrating tests
Calibration is usually performed during pre-routine operation before sample processing begins. However, it can be done anytime during routine operation as well.
u
For a detailed description of the calibration process at the beginning of routine operation,
see Performing calibration and QC (p. 280).
p To perform calibration
1 Choose Calib. and QC Select button in the Overview menu, if it is highlighted yellow.
2 Request the recommended calibrations.
CAUTION
Figure 15-2 Recommended calibration workflow during routine operation
3 Print the load list.
4 Prepare the calibrator(s).
Injury due to contact with rack loading mechanism r Only load or unload racks when the green status LEDs at the rack loading area are on.
5 Place the calibrator rack(s) into the loading area.
6 Start the calibration measurement.
If the instrument is still in Operation mode, you do not have to start the measurement from the Start window.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
421
15 Calibration
Calibration (overall system)
Status submenu
cobas® 8000 modular analyzer series
To display this submenu, choose Calibration > Status .
Color scheme
Figure 15-3 Calibration > Status submenu
Use the Status submenu to view detailed information about the calibration status of the tests on the modules selected in the Module list box. Use this submenu also to select tests for start-up, timeout, changeover or manual calibrations.
u
For information about particular tasks associated with this submenu, see:
Requesting and cancelling calibrations manually (p. 423)
Selecting tests for start-up calibrations (p. 425)
Reviewing calibration data (cobas ISE module) (p. 436)
Reviewing calibration data (photometric modules) (p. 440)
Reviewing calibration data (cobas e 602 module) (p. 449)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
The following colors are used in the calibration status list:
Color
Red
Yellow
Blue
Table 15-2
Column
Position
Meaning
The latest calibration for a reagent failed.
Or: A reagent has no valid calibration.
The instrument has recommended this test for calibration.
Cause
Cause The test has been requested for calibration.
Color scheme for status list
Roche Diagnostics
422 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (overall system)
Requesting calibrations from the Calibration > Status submenu
Calibrations are automatically recommended by the instrument and requested by the operator via the Overview menu. Instead of requesting calibrations from the
Overview menu, you may also use the Calibration > Status submenu.
The Calibration > Status submenu provides three options to request calibrations:
&DOLEUDWLRQ¬!6WDWXVVXEPHQX
&DOLEUDWH
UHFRPPHQGHGWHVWV
DXWRPDWLF
&DOLEUDWH
LQGLYLGXDOWHVWV
PDQXDO
&DOLEUDWH
VWDUWXSWHVWV
PDQXDO
6HOHFWLQGLYLGXDOWHVW
6DYH
6WDUW¬8S
3ULQW&DOLEUDWLRQ/RDG/LVW
Request calibrations from Calibration > Status submenu Figure 15-4
Calibrate recommended tests With this option you may request all tests for calibration highlighted in yellow in the
Cause column. To request the calibrations, select the Save button. This is essentially the same as selecting the Recommended button on the Calib. and QC Select window.
Calibrate individual tests With this option you may request a single test or multiple tests selected on this submenu for calibration.
u
See Requesting and cancelling calibrations manually (p. 423)
Calibrate start-up tests With this option you may request a set of tests predefined as a start-up group for calibration.
u
See Selecting tests for start-up calibrations (p. 425)
Requesting and cancelling calibrations manually
CAUTION
Incorrect results due to concentrated ISE calibrators
The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
r For ISE calibrations ensure that the calibrator is opened immediately before the calibration is performed.
p To request calibration for individual tests
1
Choose Calibration > Status .
2
Select the test that needs to be calibrated from the list.
The selected line is highlighted in gray.
Roche Diagnostics
Operator’s Manual · 4.2.1
423
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series
3 Select the appropriate method for a Blank, 2 Point, Full, or Span calibration in the
Method column.
For immunoassays, only the Full option is available.
Roche Diagnostics
424
Figure 15-5 Detail of Calibration > Status submenu
The selected option appears in the Method column, the Cause column indicates
Manual , and the Save button turns yellow.
4
To request calibrations for additional tests, repeat steps
5
Choose Save to save the changes.
All tests that have an entry in the Cause column highlighted in blue are requested for calibration.
6
Load the calibrators on the instrument as directed by the Calibrator Load List and start the measurement.
u
For detailed information, see
To load required calibrators and controls (p. 281).
s p To cancel a calibration request
1
Choose Calibration > Status .
2
Select the test whose calibration request is to be cancelled.
The selected line is highlighted in gray.
3
Select None in the Method column.
The entry in the Cause column for this test disappears and the Save button turns yellow.
4
To cancel further calibration requests, repeat steps
.
5
Choose Save to save the changes.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (overall system)
Selecting tests for start-up calibrations
The start-up calibration function serves to choose a whole set of tests collectively to simplify calibration programming. You can request a start-up calibration by choosing Start Up on the Calibration > Status submenu or on the Calib. and QC
Select window: For all tests selected for start-up calibration, a calibration request will be issued.
The set of tests that are calibrated in a start-up calibration, including the respective calibration methods, is defined on the Start Up Setting window.
p To select tests for start-up calibration
1
Choose Calibration > Status > Start Up Setting .
Roche Diagnostics
Operator’s Manual · 4.2.1
q
Figure 15-6 Start Up Setting window
2 Choose a test in the list to select it.
3 Choose a method in the Method column to request it for the selected test.
The OK button turns yellow indicating you have made a change.
For e 602 tests, only Full is available as an option.
4 Choose OK to save the start-up calibration settings and to close the Start Up
Setting window.
5 Choose Start up on the Calibration > Status submenu to activate the selected calibrations.
6 Choose Save to confirm the start-up calibrations.
s
425
15 Calibration
Calibration (overall system)
Calibrators submenu
cobas® 8000 modular analyzer series
To display this submenu, choose Calibration > Calibrators .
Figure 15-7 Calibration > Calibrators submenu
Use the Calibrators submenu to view information about already registered calibrators and the current rack assignment.
If you are using calibrators without a barcode, you must assign each calibrator to a rack number and position.
u
For information about particular tasks associated with this submenu, see:
Assigning calibrator positions (p. 426)
Loading calibrator vials for e 602 tests (p. 448)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
q If the Exp. Date column is highlighted in red , the corresponding calibrator has expired and cannot be used anymore.
Assigning calibrator positions
Use the following procedure to assign a calibrator to a rack number and position if you are using calibrators without barcode . This can only be done if the instrument is in Standby.
q Barcoded calibrators on racks assigned to non-barcoded calibrators o Do not use barcoded calibrators on racks that were assigned to non-barcoded calibrators. In this case, no calibration is performed and an alarm is issued. The rack is passed through to the rack unloading area.
o If you have to manually assign a calibrator to a calibrator rack, for example, due to an unreadable barcode, place it on the assigned rack into the correct position.
Roche Diagnostics
426 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series p To assign calibrator positions
1 Choose Calibration > Calibrators > Rack Assign .
15 Calibration
Calibration (overall system)
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 15-8 Rack Assign window for calibrators
2 From the list on the left, select the calibrator to be assigned to a rack no. and position.
3 Select a rack no. and position from the list on the right: o The position selected for the assignment has to be an unoccupied line in the list.
o
The rack positions for ISE calibrators are not fixed, but ISE Low (S1) must be placed before ISE High (S2) on the same rack. ISE High (S3) can be placed in any position behind ISE High (S2) on the same rack. o On photometric modules, the calibrator vials can be on different racks.
o
On e 602 modules, calibrator vials of the same set must be placed next to each other in the racks. Calibrators for different tests can be placed in any order.
u
For detailed information about the requirements, see:
Calibration concept (cobas ISE module) (p. 435)
Calibration concept (photometric modules) (p. 439)
Calibration concept (cobas e 602 module) (p. 445)
4 Choose Add to assign the selected calibrator to the selected position.
To undo the assignment, choose Remove or choose Cancel to leave the Rack
Assign window without saving any changes.
5 To assign further calibrators repeat steps
6 After all necessary assignments are completed, choose OK to save the changes.
s
427
15 Calibration
Calibration (overall system)
Install submenu
cobas® 8000 modular analyzer series
To display this submenu, choose Calibration > Install .
If you need to update a clinical chemistry calibrator, choose the Chemistry option from the list box. If you need to update an immunological calibrator, choose the
Immune option from the list box.
Roche Diagnostics
428
Figure 15-9 Calibration > Install (Chemistry) submenu
The Install submenu is divided into two options, Chemistry and Immune . Choose the corresponding option from the list box to access the respective submenu.
Use the Chemistry option to download, add and delete calibrators for tests performed on a photometric or ISE module, and to assign calibrator values. You can also see the details for the selected calibrator.
Use the Immune option to delete calibrators or to download calibrator information for tests performed on the e 602 module. You can also see the details for the selected calibrator.
u
For information about particular tasks associated with this submenu, see:
Checking information about already installed calibrators (p. 429)
Installing calibrators (p. 429)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (overall system)
Checking information about already installed calibrators
This section describes how to check registered calibrator information.
p To check registered calibrator information
1
Choose Calibration > Install .
2
From the list on the left, select a calibrator.
The list on the right displays the registered concentration values for this calibrator.
3
To view calibrator code, lot number, or expiration date, choose Calibration
> Calibrators .
s
Installing calibrators
Information regarding calibrator codes, lot numbers, expiration dates, and concentration values can be downloaded to the instrument from the data manager.
The data manager receives this information via an automatic update function from cobas link.
If the information about calibrators cannot be downloaded, the relevant information must be entered in the instrument manually.
u
The following procedure describes the download of new calibrator data from the data manager. The procedure also describes the update of existing calibrator data.
Supervisors may download parameters for the newest and the current release of an installed calibrator. Supervisors can neither download parameters for an older release nor parameters for a different calibrator. Administrators may download any available calibrator parameters.
Update calibrator lot to newest release
Download current release of calibrator lot again
Supervisor l l l Download different calibrator lot for an already installed calibrator (same code)
Download any calibrator and release
Table 15-3
–
User rights for downloading calibrator parameters
Administrator l l l l q Updating calibrator parameters
You do not need to delete an installed calibrator before you download a new calibrator lot or new version number of the same calibrator lot.
Roche Diagnostics
Operator’s Manual · 4.2.1
429
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series p To download calibrator data from the data manager
1 Choose Calibration > Install .
2 Choose Download to display the corresponding window.
Figure 15-10 Download window
3 Select the calibrator to be downloaded. You may use one of the search options: o
All Items : Select the calibrator directly from the list of all calibrators. o
Required Item : This search option lists all calibrators that are on board but for which the calibrator information was not yet downloaded.
o
Calibrator : Select the calibrator name from a list box.
o
Lot ID : Enter the calibrator number in the text box.
4
Choose Search to start searching for the selected criteria. The search results are displayed in the Result area.
5
Select the check box of the calibrator to be downloaded.
Roche Diagnostics
430 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
6 Choose Download to display the Confirmation window.
15 Calibration
Calibration (overall system)
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 15-11 Confirmation window
The Confirmation window shows the module types for which the calibrator is available (code and lot number must be identical).
7 Check and complete the settings displayed in the Confirmation window: o
The Current Release Date refers to the calibrator lot currently on board. This is only available if the same calibrator lot is requested for download.
o
The Addition Release Date shows the release that will be newly installed.
Administrators may select other available releases (the newest one is always on top).
Select None from the list box if you want to skip downloading the parameters for a specific module.
o
The Update Release Date is similar to the Addition Release Date , but will only be displayed if an existing calibrator is updated.
8
Choose OK to confirm the settings and to download the calibrator.
The window is grayed out for a moment until the download is finished.
9
Choose Close to return to the Calibration > Install submenu and verify that the downloaded information has been registered correctly.
s p To add calibrators manually
1 Select a blank line from the calibrator list on the Calibration > Install submenu.
2 Choose Add .
431
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series
3 Type all necessary data in the Add window.
Figure 15-12
4
Choose OK .
Add window
The new calibrator appears on the calibrator list.
To run tests with the newly installed calibrators, it is necessary to manually enter the calibration values for each test.
u
For instructions on entering calibration information manually, see
Editing concentration values (p. 432).
s
Editing concentration values
The concentration value of a calibrator can be edited on the Calibration > Install submenu. The instrument must be in Standby.
p To enter or edit concentration values of a calibrator
1
Choose Calibration > Install .
2
Select Chemistry option from the list box.
3
From the list on the left, select the calibrator to be edited.
Roche Diagnostics
432 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
4 Choose Edit .
The Edit window is displayed.
15 Calibration
Calibration (overall system)
CAUTION
Figure 15-13 Edit window (calibrators for photometric tests)
5
Select a test (analyte) from the list whose calibrator concentration value is to be entered or edited.
6
Select a box in the Std Concentration area and type in the appropriate concentration value. Observe the respective unit of measure displayed below the
Std Concentration area.
For c modules, Std (1) is used for the blank calibrator. Std (2) through Std (6) are used for all other calibrators.
7
After all necessary values are entered, complete the input by choosing Update .
8
If you need to edit additional tests, repeat steps
through
9
Choose OK to save all changes and close the window.
Incorrect results due to wrong calibration
After changing the calibrator concentration for any calibrator Std (1)-Std (6), the calibration curve is immediately updated. For Std (1) this affects all calibration types, for Std (2)-(6) it affects the calibration types Spline, Line graph, RCM, RCM2T1,
RCM2T2. The calibration curve is updated even before the actual calibration measurement is performed.
r In order to avoid incorrect results, the number of decimal places shall be changed in Utility > Application > Range if required.
r Always re-calibrate the test to obtain a lot calibration in order to ensure no incorrect results have been reported for the current reagent lot or for all previously registered reagents lots that will be used. In addition, reagent packs currently in use must be re-calibrated and temporarily unloaded.
r Make sure to perform the calibration measurements prior to any other determinations.
10 Calibrate the test.
Roche Diagnostics
Operator’s Manual · 4.2.1
433
15 Calibration
Calibration (overall system) cobas® 8000 modular analyzer series q
11 Perform QC measurements.
Manually edited concentration values will be overwritten
If a concentration value was manually edited and you download the same version of ebarcode from the data manager again, the manually edited values will be overwritten.
s
Roche Diagnostics
434 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (cobas ISE module)
Calibration (cobas ISE module)
This section contains information on the calibration concept for this module and how to review calibration results.
Calibration concept (cobas ISE module)
Full calibration
CAUTION
Full calibration for Na
+
, K
+
, and Cl
- in the ISE module requires the following
3 calibrator solutions (standards): o
ISE Low (S1) o
ISE High (S2) o
ISE High (S3)
Incorrect results due to misplacement of ISE calibrators r The rack positions for ISE calibrators are not fixed, but ISE Low (S1) must be placed before ISE High (S2) on the same rack. ISE High (S3) can be placed in any position behind ISE High (S2) on the same rack.
r For non-barcoded calibrators observe the same rules. Furthermore, the calibrator positions must be set under Calibration > Calibrators > Rack Assign .
r When barcoded calibrators are used, no position assignment is required.
CAUTION
The slope of the calibration curve is calculated from ISE Low (S1) and ISE High (S2).
ISE High (S3) is designed to reduce matrix effects.
q A full calibration is required every 24 hours.
Incorrect results due to concentrated ISE calibrators
The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
r For ISE calibrations ensure that the calibrator is opened immediately before the calibration is performed.
One-point calibration The ISE internal standard (ISE IS) is measured before and after each routine sample
(only one measurement for sample analyses in succession). These measurements are used to correct for system-related drifts (junction potential differences, differences in electrode conditions, and the like).
Calibration Method The availability of calibration methods depends on the kind of test that is to be calibrated. The following table displays all calibration methods and the corresponding calibrators of ISE tests.
u
For the recommended calibration methods please refer to the Instructions for Use.
Blank
Span
2 Point
Full
Only ISE High (S3) [Std (3)] is used
Not available
ISE Low (S1) [Std (1)] and ISE High (S2) [Std (2)] are used
ISE Low (S1) [Std(1)], ISE High (S2) [Std(2)], and ISE High (S3) [Std (3)] are used
Roche Diagnostics
Operator’s Manual · 4.2.1
435
15 Calibration
Calibration (cobas ISE module) cobas® 8000 modular analyzer series
Two ISE calibration curves For ISE tests it is possible to set up and use two independent sets of calibration curves for Na
+
, K
+
, and Cl
-
. The assignment of one or the other calibration curve to a certain sample type is set on Utility > System > ISE Calib. Settings .
After installation and assignment of calibrators, the following calibrator values are displayed on Utility > Application > Other : o
Calibrator Code o
Concentration o
Rack Assign (status) q The rack assignment status is displayed as Assigned when a rack position is already assigned.
The Other parameter contains two areas, Type A and Type B , where each area relates to one of the two independent calibration curves.
u
For more information please refer to the Online Help .
Reviewing calibration data (cobas ISE module)
Details for each calibration performed on any of the instrument’s modules can be retrieved from the Calibration > Status submenu. The following section describes how to check calibration data.
Checking calibration results
For each successful calibration of an ISE test, the following information is available: o
Calibration result (ISE):
Results from the most recent successful ISE calibration for the test selected.
o
Calibration trace:
A graph used to review the measurements of the 50 most recent calibrations for a specific test. It shows both the measured data for ISE High (S3) (in mmol/L) and slope values (in mV) of a selected test on one plot.
o
Monitor window
Calibration information is displayed in the Monitor window. Choose Monitor
(global button) to display the Monitor window.
p To review calibration data
1
Choose Calibration > Status .
2
Select ISE in the Module list box.
3
Select an ISE test from the list.
q The entries ISE-A and ISE-B refer to two different calibration curves that can be assigned to different sample types. For example, ISE-A is assigned to serum/plasma and ISE-B to urine samples. This assignment is set on Utility > System > ISE Calib.
Settings .
Roche Diagnostics
436 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (cobas ISE module)
4 Choose Calibration Result to display the Calibration Result window.
Figure 15-14 Calibration Result (ISE) window
This window displays information about the most recent successful ISE calibration: Electromotive force (EMF), slope, and target concentration values.
The Compensated Value row displays the difference between the target value of
[ISE Std (3)] (ISE High (S3)) and its measured values for Na
+
, K
+
, and Cl
-
. This difference is added to all measured routine samples and controls.
The slope of the calibration curve is calculated from ISE Standards 1 and 2.
ISE High (S3) is designed to reduce matrix effects. It only affects the intercept and not the slope.
s p To review results of previous ISE calibrations
1
Choose Calibration > Status .
2
Select ISE in the Module list box.
3
Choose Calibration Trace to open the Calibration Trace window.
Roche Diagnostics
Operator’s Manual · 4.2.1
437
15 Calibration
Calibration (cobas ISE module) cobas® 8000 modular analyzer series
4 Select a test from the Test/Module list box on the top left of the window.
q
Figure 15-15 Calibration Trace (ISE) window
The graph shows calibration results for the selected ISE test. The left and right y-axes are scaled independently: o The left axis refers to the measured concentration values of the standard
ISE High (S3) represented by . o
The right axis refers to the calculated slope values represented by .
u
For a complete description of all fields and buttons, refer to the Online Help .
5 Select the data point you want to view.
The calibration trace can be printed out.
Select a test from the Calibration > Status submenu before you choose Print .
u
For more information, see Printing reports (p. 483).
s
Roche Diagnostics
438 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (photometric modules)
Calibration (photometric modules)
This section contains information on the calibration concept for the c 701 / c 702 and c 502 modules and how to review calibration results.
Calibration concept (photometric modules)
Types of calibration curves There are six different types of calibration curves possible on photometric modules.
One of the six different types of mathematical functions is used to describe the relation between a measured value and a result.
In this document and in the user interface (UI), these types of calibration curves are called calibration types. The names of the calibration types are:
Linear
RCM
Table 15-4
RCM2T1
RCM2T2
Calibration types for photometric tests
Spline
Line Graph
Each calibration type corresponds to one type of mathematical function. For example, Linear corresponds to a linear equation, RCM2T2 to an exponential function.
u
For more details about the calibration types, refer to the COBI CD .
Calibration curve parameters A specific calibration curve is defined by its calibration type (mathematical function) and its parameters. The names of these parameters in the user interface are: o
S1Abs.
, K , A , and B .
A Linear calibration curve, for example, is defined by two parameters ( S1Abs.
and
K ), an RCM calibration curve is defined by four, and a Spline can require up to six parameters. When the instrument performs a calibration, it redetermines these parameters to fit the calibration curve to new measurement values.
Calibration methods Calibrations are performed with varying numbers of calibrators. Up to six calibrators are used for a full calibration of certain photometric tests. However, not all calibrators available for a test need to be used in every calibration. To define which calibrators are used, there is a choice of up to four different calibration methods.
The availability of calibration methods depends on the kind of test that is to be calibrated. The following table displays all calibration methods and the corresponding calibrators for photometric tests.
Blank
Span
2 Point
Full
Std (1)
(1)
is used
Only one calibrator out of
Std (2)-Std (6)
(2)
is used
Std (n)
(3)
and a second calibrator are used
All calibrators [Std (1)-Std (6)] are used (for nonlinear calibration types)
(1) Std (1) is the first standard solution, that is, the calibrator of the lowest analyte concentration. For photometric applications, water is used as a blank calibrator.
(2) Std (2)-Std (6) refer to calibrators assigned to an application under Utility > Application > Others .
(3) Std (n) defined under Utility > Application > Calib.
refer to one of the calibrator Std (1) to Std (6).
Roche Diagnostics
Operator’s Manual · 4.2.1
439
15 Calibration
Calibration (photometric modules) cobas® 8000 modular analyzer series
Calibration rules o
Calibration is best done as a part of the daily pre-routine operation. However, it can be done at any time during operation as well.
o
Calibrations are carried out in duplicate.
o
Expired calibrators cannot be used.
o
Barcoded calibrators:
Roche calibrators are always supplied with barcode labels (inserted in the calibrator kit). The labels must be placed on a tube.
o
Non-barcoded calibrators:
In this case calibrators have to be assigned to specific racks and positions (rack assignment).
o
For lyophilized calibrators:
Carefully dissolve the content of a bottle according to the Instructions for Use.
Mix carefully, avoiding foam formation. Transfer the dissolved calibrator to a cup or tube.
o
Positioning of calibrators:
Calibrators are placed in calibrator racks (black racks). Calibrators for the same test must be placed next to each other in the racks.
Lot and cobas c pack calibrations
Lot calibration Lot calibration data are reagent lot specific for the test. Lot calibration data are transferred to other cobas c packs belonging to the same reagent lot. This means, lot calibration data generated by a cobas c pack are applied to result calculations of all patient samples and controls using cobas c packs of the same lot.
A lot calibration can only be generated from a fresh cobas c pack. The calibration must be performed within 24 hours after the cobas c pack has been registered by the instrument.
cobas c pack calibration The cobas c pack calibration data are cobas c pack-specific. A cobas c pack calibration is generated when a cobas c pack, which is older than 24 hours after being registered by the instrument, is calibrated and all calibration quality criteria are met.
q Expired cobas c packs can only generate a cobas c pack calibration.
Newest calibration For a cobas c pack for which no applicable calibration data exists, the newest calibration result is transferred at the time of reagent registration.
For example: A cobas c pack of a new lot that was loaded on the instrument does not have any calibration data. Always the newest calibration data (the data of the last valid lot calibration) are transferred.
u
For more information about Lot and cobas c pack calibrations for c modules, refer to the
COBI CD.
Reviewing calibration data (photometric modules)
Details for each calibration performed on any of the instrument’s modules can be retrieved from the Calibration > Status submenu. The following section describes how to check calibration data.
Roche Diagnostics
440 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (photometric modules)
Checking calibration results
For each successful calibration of a photometric test, the following information is available: o
Calibration result (photometric):
Summary of calibration results for photometric tests.
o
Calibration curve :
Mathematical relation between the measured signal (for example, absorbance or rate of change in absorbance) and the corresponding concentration value for the analyte concerned. ( Working Information ) o
Reaction monitor :
A graph showing the measured absorbance in the course of a test measurement.
o
Calibration trace :
A graph used to review the measurements of the 50 most recent calibrations for a specific test. It shows signal values for both, the Std (1) calibrator and the calibrator with the maximum concentration on one plot.
o
Monitor window
Calibration information are displayed in the Monitor window. Choose Monitor
(global button) to display the Monitor window.
p To review calibration data
1
Choose Calibration > Status .
2
Select a photometric test from the list.
3
Choose Calibration Result to display the Calibration Result window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 15-16 Calibration Result (Photometry) window
This window gives information about the most recent calibrations for the displayed photometric test.
4
To display the calibration curve of a selected test, choose Working Information .
s
441
15 Calibration
Calibration (photometric modules) cobas® 8000 modular analyzer series p To review measurement details of the most recent calibration
1 Choose Calibration > Status .
2 Select a photometric test from the list.
3 Choose Reaction Monitor to display the Reaction Monitor window.
Roche Diagnostics
442 q
Figure 15-17 Reaction Monitor window
This window displays reaction graphs for each of the duplicate measurements of each calibrator used for the calibration selected.
4 Use the list box above the graph to select a specific measurement. The extensions
1st and 2nd in the list correspond to the first and second measurement of each calibrator, respectively.
u
For a complete description of all fields and buttons, refer to the Online Help .
Reaction monitor graphs of a calibration can be printed out.
Select a test from the Calibration > Status submenu before you choose Print .
u
For more information, see Printing reports (p. 483).
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (photometric modules) p To review results of previous calibrations
1 Choose Calibration > Status .
2 Select a photometric test from the list.
3 To review the results of previous calibrations of the selected test, choose
Calibration Trace .
Roche Diagnostics
Operator’s Manual · 4.2.1
q
Figure 15-18 Calibration Trace window
This window displays a graph showing calibration results for both the Std (1) calibrator and the calibrator with the maximum concentration on one plot.
The left and right y-axes are scaled independently: o The left axis refers to the Std (1) calibrator represented by .
In case of a rate assay, it indicates the primary wavelength absorbance at photometric measuring point 1 of Std (1).
o The right axis refers to the Std (2)-(6) calibrator represented by .
u
For a complete description of all fields and buttons, refer to the Online Help .
4 Select the data point you want to view.
The calibration trace can be printed out.
Select a test from the Calibration > Status submenu before you choose Print .
u
For more information, see Printing reports (p. 483).
s
443
15 Calibration
Calibration (photometric modules)
Editing K factors cobas® 8000 modular analyzer series
For some applications, the K factor must be edited according to the Instructions for
Use. The following procedure is applicable only to calibrations of photometric tests.
q Edited factors are used for lot and newest calibration data
If you edit the factors for a cobas c pack within 24 hours after loading this new cobas c pack and lot calibration data for this cobas c pack are not available, then the edited factors are used as r. pack, lot, and newest calibration data.
If you edit the factors for a cobas c pack which already has calibration data, then only the r. pack calibration data is changed.
p To edit K factors
1
Choose Calibration > Status .
2
Select the name of the test whose K factor needs to be modified.
3
Choose Calibration Result to display the Calibration Result window. The selected test is highlighted.
Roche Diagnostics
444
Figure 15-19 Calibration Result (Photometry) window
4
Type the revised K factor in the column K of the highlighted line.
5
Choose OK to save the revised setting.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (cobas e 602 module)
Calibration (cobas e 602 module)
This section contains information on the calibration concept for this module, how to load calibrator vials, and how to review calibration results.
Calibration concept (cobas e 602 module)
Calibration is a process to establish a relation between measurement values (such as
ECL signals) and the corresponding results (concentration of an analyte). This relation depends on both instrument conditions and reagent conditions. For this reason, Roche Diagnostics (RD) supplies a master calibration curve for each application (generated during production of the reagent kit). At customer site, the instrument generates an update of this master calibration curve under the local routine laboratory conditions. A calibration curve updated in this manner is also referred to as working curve.
5''HYHORSPHQW
5'3URGXFWLRQ
&XVWRPHU
Figure 15-20 Calibration concept for immunoassays
Calibration rules o
Calibration is best done as a part of the daily pre-routine operation. However, it can be done at any time during operation as well.
o
Elecsys test-specific calibrators are used. Calibrator data are downloaded from the data manager.
o
Calibrations are carried out in duplicate.
o
Calibrations for both measuring channels are automatically carried out from the same calibrator set if both measuring channels are to be calibrated.
o
Expired calibrators cannot be used.
o
If calibration is recommended due to QC violation because of improper placement of controls (reversed order), the control material can be run again. If the controls return to their confidence range, the calibration request is removed.
For lyophilized calibrators: Carefully dissolve the content of a bottle according to the Instructions for Use.
Carefully mix, avoiding the buildup of froth. Transfer the dissolved calibrator to the empty, labeled CalSet vials using the additional vials and labels provided.
Roche Diagnostics
Operator’s Manual · 4.2.1
445
15 Calibration
Calibration (cobas e 602 module) cobas® 8000 modular analyzer series
For liquid e 602 calibrators: If the total volume is not required for calibration on the e 602, divide the ready-to-use calibrator in the CalSet vials using the additional vials and labels provided. Store the reserved calibrator portion according to the Instructions for Use.
Positioning of calibrators Calibrators are placed in calibrator racks (black racks).
o
Calibrator vials of the same set must be placed next to each other in the racks.
Calibrators for different tests can be placed in any order. Important: Do not separate the vials of a calibration set.
o
In order to process calibrations in parallel on two e 602 modules, the calibration racks can be sequenced for the individual modules.
Routine calibrators and inpack calibrators
Two types of calibrators are used for immunoassays: Routine calibrators and inpack calibrators. Inpack calibrators are calibrators delivered within the reagent package.
The following rules apply to both types of calibrators: o
Up to 100 calibrators can be installed on the instrument.
o
Download the parameters to install a calibrator. This includes the expiration date.
o
Only one calibrator lot may be downloaded and run at the same time.
Differences between normal and inpack calibrators:
Identification
Lot allocation
Routine calibrator
By calibrator code
One calibrator lot may correspond to several reagent lots (max. 99 calibrator lots).
Inpack calibrator
By calibrator code and lot number
One calibrator lot must correspond to the same reagent lot. A maximum of 10 calibrator lots can be downloaded for inpack calibrators.
Table 15-5 Routine calibrators vs. inpack calibrators q Number of reagent lots
Up to three reagent lots can be registered to one test. If more than three reagent lots are registered to one test, operation cannot be continued until the reagent is removed from the instrument.
Lot and cobas e pack calibrations
Lot calibrations Every new reagent lot must be calibrated. Lot calibration data are reagent lot-specific for the test. Lot calibration data are transferred to other cobas e packs belonging to the same reagent lot. This means that lot calibration data generated by a cobas e pack are applied to result calculations of all patient samples and controls using cobas e packs of the same lot.
Exception: Some tests require that each cobas e pack is calibrated even though the packs are of the same lot. If the Reagent Pack check box under Utility > Application
> Calib.
is selected and a new cobas e pack of this test is placed onto the system, this cobas e pack receives a changeover request for calibration.
A lot calibration can only be generated from a fresh cobas e pack. The calibration must be performed within 24 hours after the cobas e pack has been registered by the instrument. Calibrations are channel-specific, that is, each measuring channel is calibrated separately.
Roche Diagnostics
446 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (cobas e 602 module) cobas e pack calibrations The cobas e pack calibration data are cobas e pack specific. A cobas e pack calibration is generated when a cobas e pack that has been on the module longer than
24 hours is calibrated for the first time and all calibration quality criteria are met.
q Expired cobas e packs (reagent or diluent) can only generate a cobas e pack calibration.
u
For more information about Lot and cobas e pack calibrations for e 602, refer to the
COBI CD.
Calibration quality criteria
Calibration measurements are automatically checked against various quality criteria.
The assessment is different for qualitative and quantitative assays. The following tables show which criteria are used for quantitative and for qualitative assays.
Results of the calibration checks are displayed on the Calibration Result window. To open this window, select an e 602 test from the Calibration > Status submenu and choose Calibration Result .
If one of the quality criteria is not met, the corresponding calibration alarm is attached to the result:
Quantitative assays
Quality criterion Corresponding calibration alarm
Missing values
Monotony of curve
Minimum signal
NG (Not good)
(1)
Mono.E
<Sig
Calibration factor
Minimum difference
Factor
Diff.E
Deviation of duplicate measurement
System error
Table 15-6
Dup.E
Sys.E
(1)
Quality criteria for quantitative assays
(1) Depending on the cause, additionally an instrument alarm may be issued.
Qualitative assays
Quality criterion
Missing values
Slope
Minimum signal
Maximum signal
Minimum acceptable difference
Deviation of duplicate measurement
Corresponding calibration alarm
NG (Not good)
Slop.E
<Sig
>Sig
Diff.E
Dup.E
Sys.E
(1)
(1)
System error
Table 15-7 Quality criteria for qualitative assays
(1) Depending on the cause, additionally an instrument alarm may be issued.
u
For explanation of these calibration quality criteria for e 602, refer to the COBI CD .
Roche Diagnostics
Operator’s Manual · 4.2.1
447
15 Calibration
Calibration (cobas e 602 module)
Loading calibrator vials for e 602 tests
cobas® 8000 modular analyzer series
The calibrators used for the calibration of e 602 tests come in barcoded vials. To ensure correct pipetting from these vials, it is important that they are placed correctly in the calibration racks.
q o Before placing calibrators and controls into the loading area, check that no bubbles or foam are visible on the liquid surface.
o Barcoded calibrator vials for e 602 modules can be used for a maximum of 4 calibrations.
o Before placing calibrator vials on the rack, make sure that you attached the correct barcode label to the calibrator vial. The barcode labels for cobas 8000 can be found in the calibrator kit.
p To load calibrator vials
1
Place both calibration vials of a CalSet in a black calibrator rack according to the figure below.
Roche Diagnostics
448
Figure 15-21 Loaded vial on calibrator rack
2 Open the lid of the calibrator vials, ensuring that they are perpendicular to the rack (see figure above).
3 Load the calibrator rack into the loading area.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 15 Calibration
Calibration (cobas e 602 module)
Reviewing calibration data (cobas e 602 module)
Details for each calibration performed on any of the instrument’s modules can be retrieved from the Calibration > Status submenu. The following section describes how to check calibration data.
Checking calibration results
For each successful calibration of an e 602 test, the following information is available: o
Calibration results (Immune):
A list showing target and signal values for the test selected on the Calibration
> Status submenu.
o
Calibration trace :
A graph used to review the measurements of the 50 most recent calibrations for a specific test. It shows signal values for both calibrators [Std (min) and Std (max)] on one plot.
o
Monitor window
Calibration information is displayed in the Monitor window. Choose Monitor
(global button) to display the Monitor window.
p To review calibration data
1
Choose Calibration > Status .
2
Select an e 602 test from the list on Calibration > Status .
3
Choose Calibration Result to display the Calibration Result window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 15-22 Calibration Result (Immune) window
This window displays information relating to the calibration currently used for the selected heterogeneous immunology test (signal levels, calibration criteria).
s
449
15 Calibration
Calibration (cobas e 602 module) cobas® 8000 modular analyzer series p To review results of previous calibrations
1 Choose Calibration > Status .
2 Select an e 602 test from the list on Calibration > Status .
3 Choose Calibration Trace to open the Calibration Trace window.
4 Select a test from the drop-down list on the top left of the window.
Roche Diagnostics
450 q
Figure 15-23 Calibration Trace window for e 602 tests
The graph shows calibration data for the selected test; it displays the measured signal values for both the low concentration calibrator, Std (min), and the high concentration calibrator, Std (max), on one plot.
The left and right y-axes are scaled independently: o The left axis refers to the Std (min) calibrator, represented by .
o
The right axis refers to the Std (max) calibrator, represented by .
u
For a complete description of all fields and buttons, refer to the Online Help .
5 Select the data point you want to view.
The calibration trace can be printed out.
Select a test from the Calibration > Status submenu before you choose Print .
u
For more information, see Printing reports (p. 483).
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
QC
16 QC
16
Roche Diagnostics
Operator’s Manual · 4.2.1
This chapter describes certain tasks associated with the QC menu as well as special tasks that are not usually part of the daily workflow.
In this chapter
Chapter
16
Requesting QC measurements from QC > Status submenu ................................. 462
Unloading auto QC racks from the auto QC compartment.................................. 465
451
16 QC
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
452 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Introduction
Introduction
The following section gives an overview of the QC concept applied by the cobas 8000 system; it provides you with a basic understanding of the various QC functionalities implemented on the instrument and its software.
Usage recommendations for QC
QC measurements may be requested in different ways: o
Manually by the user
O using the Calib. and QC Select button in the Overview menu
O using the QC > Status submenu o
Automatically by the instrument
O using automatic QC
For QC measurement, five QC types are available. The following table shows where each QC type may be requested.
o o
Routine QC o
Standby Bottle QC
QC after Calibration o
Timeout QC o
Manual QC
Table 16-1
QC request from
Calib. and QC Select l l
(1)
QC request from
QC > Status l l
(1) l
( Recommended button) l u
See Performing calibration and QC
l u
See
Different methods for QC requests
Automatic QC request and measurement
(2) l u
(1) QC after calibration does not have to be requested (see
To perform QC after calibration (p. 460)).
(2) QC after calibration can also be performed using automatic QC measurement (see
Automatic QC request (p. 454)).
See
Automatic QC request (p. 454).
Manual QC request
Five QC types are available for manual QC requests:
Routine QC Each test has one or more controls assigned to it. Moreover, a test must be not only assigned to a control but also activated for that control to make a QC measurement possible. Routine QC comprises all activated tests of all installed controls.
With the Routine QC Test Selection function no QC request is necessary. You can activate the Routine QC Test Selection function on Utility > System > Calib. and
QC Settings . Enable this function if the controls for all activated tests are to be measured in one single run (for example in the morning).
u
For more information about routine QC, see:
To perform QC during pre-routine operation (p. 459)
To request controls for active reagents (p. 463)
To program automatic QC request for Routine QC (p. 526)
Roche Diagnostics
Operator’s Manual · 4.2.1
453
16 QC
Introduction cobas® 8000 modular analyzer series
Standby Bottle QC QC measurements can be requested individually for standby reagents. Standby reagents are reagent packs already on board but not in use at present. If standby reagents are on board, we recommend requesting a QC measurement together with the Routine QC at the beginning of a work shift.
u
For more information about Standby Bottle QC, see:
To perform QC during pre-routine operation (p. 459)
To request controls for standby reagents (p. 464)
QC after calibration For this QC type, no special settings are needed. Whenever a calibrator rack (black) is immediately followed by a QC rack (white), QC measurements are performed for all calibrated tests, without explicit requests from the operator.
u
For more information about QC after calibration, see:
To perform QC after calibration (p. 460)
Timeout QC QC measurements can be performed at predefined (test-specific) time intervals.
When the time interval has elapsed, the system issues a recommendation for a QC measurement. This is indicated by the Calib. and QC Select button in the Overview menu lighting up in yellow or by the word Timeout in the Cause column on QC
> Status submenu.
u
For more information about timeout QC, see:
To perform QC during routine operation (Timeout QC) (p. 460)
Manual QC This function allows you to measure QCs of any items based on your judgment. For example if a QC measurement fails, select this control manually on QC > Status submenu and start a new QC measurement.
u
For more information about manual QC, see:
Requesting QC measurements from QC > Status submenu (p. 462)
To request controls for active reagents (p. 463)
Automatic QC request
There are three different types of automatic QC measurement. It is possible to keep controls in the auto QC compartment for all types—ready to be used any time before or during routine operation. When working with the auto QC compartment, define the on-board stability for the controls.
u
See To define the on-board stability for an auto QC (p. 559)
Timeout QC A control interval in hours can be defined for each application on Utility
> Application > Range . The system checks the timeout every minute. When the specified time has elapsed, a QC request is triggered. If there is an auto QC rack in the auto QC compartment with a suitable control, the system performs automatic QC measurements without any intervention by the operator. The control is measured with the active (in use) reagent packs.
o
Auto QC requests are bundled together in QC events: The system requests timeout QC once every hour after operation was started.
o
Timeout QC requests are displayed on QC > Status until the QC rack is loaded and passed the barcode reader. To request the timeout QC, choose Save before the QC rack is loaded.
Roche Diagnostics
454 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Introduction o
When a reagent pack changeover from standby to current occurs, two cases must be distinguished:
1) If no QC measurement was performed with the former standby (now current) reagent pack before, then a timeout QC request is generated. Therefore, the auto QC rack must be loaded after the changeover.
2) If a standby QC was measured with this reagent pack before, QC will only be requested when the hourly QC event occurs.
u
See To program automatic QC measurements for timeout QC (p. 558).
QC after Calibration You can activate the Auto QC with QC after Calibration function on Utility
> System > Calib. and QC Settings . If there is an auto QC rack in the auto QC compartment with a suitable control, the system performs automatic QC measurements after calibration without any intervention by the operator. u
See To program automatic QC measurements for QC after calibration (p. 526).
Auto. QC after loading of reagent pack ( c 702 only)
If there is an auto QC rack in the auto QC compartment with a suitable control, the system performs Stand By Bottle QC measurements without any intervention by the operator when a new reagent pack was loaded. The Auto. QC Request to Loading R.
Pack check box must be activated on Utility > System > Calib. and QC Settings . u
See To program automatic QC requests when new reagents are loaded (c 702 only) (p. 526).
Validation of QC
After measurement of QC samples, the results are displayed on the Workplace
> Data Review submenu and transferred to the data manager. On the data manager
QC statistics are calculated. The validated results of the QC are transferred back to the control unit PC and displayed on the QC > Run Status submenu.
u
For more information on validation, see
To validate calibration and QC results (p. 282)
u
For information on validating QC results, please refer to the data manager component
QC routine in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
Containers and racks for control samples
All control samples must be loaded in white QC racks only.
Control samples to be used in auto QC measurements are defined by a range of rack numbers. The range must be specified on Utility > System > Rack Assignment .
u
For information on container types applicable for controls, see:
Which container for which application?
Roche Diagnostics
Operator’s Manual · 4.2.1
455
16 QC
Introduction
Controls with or without barcodes
CAUTION cobas® 8000 modular analyzer series
Quality controls can be used either with or without barcodes.
When working with barcodes, controls are automatically identified. If controls are processed without barcode, it is necessary to assign a rack number and rack position for each control.
The current rack assignment is listed on the QC > Controls submenu. To provide additional assignments or remove existing assignments, choose Rack Assign .
Incorrect QC results due to position mismatch
A misplacement of assigned controls (without barcode) would go undetected by the system and yield completely invalid results.
r If working with non-barcoded controls, ensure correct positions of the controls.
q o Do not mix barcoded and non-barcoded controls within a rack. Be consistent with the settings on QC > Controls .
o Do not mix different container types, such as non-standard tubes, false bottom tubes, and standard tubes. Be consistent with the settings on Utility > System > Rack
Assignment .
u
For more information, see:
Assigning control positions (p. 469).
Roche Diagnostics
456 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Menu summary
Menu
Overview menu
16 QC
Menu summary
The following sections describe how QC is managed with the cobas 8000 instrument software.
Function
The Overview menu supports QC management in the following way:
The Calib. and QC Select button provides direct access to important functions on managing controls: The button enables to request tests for QC and print a QC Load List .
u
See
QC > Status submenu
QC > Run Status submenu
The QC > Status submenu is used to perform the following: o
To view all installed controls with the corresponding assigned and activated tests for each module, reagent disk, and measuring channel o
To view timeout QC recommendations from the instrument o
To select tests for QC (routine, stand by bottle, timeout or manual QC) o
To unload auto QC racks u
See
The QC > Run Status submenu is used to perform the following: o
To get an overview of the last 500 QC measurements performed on the instrument o
To view the most recent QC measurements for one particular test specified u
See
Table 16-2 Menu overview
Roche Diagnostics
Operator’s Manual · 4.2.1
457
16 QC
Menu summary
Menu
QC > Controls submenu
QC > Install submenu cobas® 8000 modular analyzer series
Function
The QC > Controls submenu is used to perform the following: o
To review information about already registered controls o
To assign controls to specific racks and positions u
See
The QC > Install submenu is used to perform the following: o
To download controls from the data manager or delete controls from the instrument o
To activate/inactivate tests for the controls o
To view the details of a selected control u
See
Table 16-2 Menu overview
Roche Diagnostics
458 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Overview menu
16 QC
Overview menu
The following section explains QC tasks associated with the Overview menu. Choose the Overview button in the menu line, or press the F12 key to display the Overview menu.
QC measurement
QC measurement is usually performed during pre-routine operation before sample processing begins. However, it can be done anytime during routine operation as well.
This section describes the following procedures to order QC: o
To perform QC during pre-routine operation (p. 459)
u
For more information, see:
o
To perform QC during routine operation (Timeout QC) (p. 460)
If the instrument issues a recommendation for a QC measurement, request the
QC measurement and start it.
u
For more information, see
o
To perform QC after calibration (p. 460)
u
For more information, see
The recommended workflow for measuring calibrators and QC is described in
chapter 12 Daily operation (p. 269).
u
For more information, see:
Performing calibration and QC (p. 280)
Calibration and QC workflow (p. 280)
p To perform QC during pre-routine operation
1 Choose Calib. and QC Select button in the Overview menu.
2 Select Routine QC and Stand By Bottle QC .
CAUTION
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 16-1
3 Print the load list.
Recommended QC workflow during pre-routine operation
Injury due to contact with rack loading mechanism r Only load or unload racks when the green status LEDs at the rack loading area are on.
459
16 QC
Overview menu cobas® 8000 modular analyzer series
4 Load the controls onto the instrument as directed by the QC Load List and start the measurement.
If the instrument is still in Operation mode, you do not have to start the measurement from the Start window.
u
For a detailed description of the QC process at the beginning of routine operation, see
Performing calibration and QC (p. 280).
s p To perform QC during routine operation (Timeout QC)
1 Choose Calib. and QC Select button in the Overview menu, if it is highlighted yellow.
2 Request the recommended QC.
Figure 16-2 Recommended QC workflow during routine operation
3 Print the load list.
4 Load the controls onto the instrument as directed by the QC Load List and start the measurement.
If the instrument is still in Operation mode, you do not have to start the measurement from the Start window.
s p To perform QC after calibration
1
Choose Calib. and QC Select button in the Overview menu.
2
Request the calibration.
Roche Diagnostics
460 q
Figure 16-3 Workflow for QC after calibration
3
Print the calibration and QC load list.
4
Load the calibrators and controls onto the instrument as directed by the
Calibrator Load List and the QC Load List and start the measurement.
The QC rack must be loaded directly after the calibrator rack.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Status submenu
To display this submenu, choose QC > Status .
16 QC
Status submenu
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 16-4 QC > Status submenu
Use the Status submenu to view detailed information about the QC status of the tests on the modules selected in the Module list box. Use this submenu also to select tests for manual QC or to unload QC racks from the auto QC compartment.
The list can be sorted by *, Module , Test , Control , S. Type , or Lot ID . Select or deselect a test for QC in the Select column of the corresponding test. Selected tests have a check mark in the Select column. Choose Save to request QC measurements for the selected tests.
q After the control is measured, the QC requests are automatically deleted in the status list. If a test is requested but the control is not processed, the QC request remains.
* An asterisk (*) in the second column of the QC > Status submenu denotes which control is used as automatic QC and is on the instrument.
u
For more information, see Automatic QC request (p. 454).
u
For information about particular tasks associated with this submenu, see:
Requesting QC measurements from QC > Status submenu (p. 462)
Requesting QC measurements manually (p. 463)
Selecting tests for standby bottle QC (p. 464)
Unloading auto QC racks from the auto QC compartment (p. 465)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
461
16 QC
Status submenu
Color scheme
cobas® 8000 modular analyzer series
The following colors are used in the QC Status list:
Color
Yellow
Yellow
Table 16-3
Column Meaning
*
Cause
The on-board stability is exceeded for controls in the auto
QC compartment.
The instrument has recommended this test for QC measurement.
Color scheme for status list
Requesting QC measurements from QC > Status submenu
Instead of requesting QC measurements from the Overview menu, you may also use the QC > Status submenu. On this submenu QC measurements may be manually requested for active as well as for standby reagents. Active reagents are reagent packs currently in use. Standby reagents are reagent packs already on board but not in use at present.
u
For more information, see Performing calibration and QC (p. 280).
5HTXHVW
UHFRPPHQGHG4&V
DFWLYHUHDJHQWV
4&¬!6WDWXVVXEPHQX
5HTXHVW4&V
PDQXDOO\DFWLYH
UHDJHQWV
5HTXHVWURXWLQH4&
DFWLYHUHDJHQWV
5HTXHVWVWDQGE\
UHDJHQW4&
6HOHFWLQGLYLGXDOWHVW 5RXWLQH4&$VVLJQ
6DYH
6WDQG%\%RWWOH4&
2.
3ULQW4&/RDG/LVW
Figure 16-5 Requesting QCs from QC > Status submenu
The QC > Status submenu provides four options to request QC measurements:
Request recommended QCs With this option you may request all tests with a Timeout in the Cause column for
QC. To request the QC measurement, select the Save button. This is essentially the same as selecting the Recommended button on the Calib. and QC Select window.
u
See To perform QC during routine operation (Timeout QC) (p. 460)
Request QC manually With this option you may request a single test or multiple tests selected from this submenu for QC measurement. Select the control manually from this submenu and start a new QC measurement.
u
See Requesting QC measurements manually (p. 463).
Roche Diagnostics
462 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Status submenu
Request routine QC With this option you may request all routine QC tests (current reagents only) for a
QC measurement. This is essentially the same as selecting the Routine QC button in
Calib. and QC Select window. u
See Requesting QC measurements manually (p. 463).
Request standby bottle QC With this option you may request a single test or multiple test selected on the Stand
By Bottle QC window for QC measurements.
u
See Selecting tests for standby bottle QC (p. 464)
q o If expired controls are used on photometric or immunological modules, an alarm occurs. It is not possible to measure an expired control.
o Do not use barcoded controls on racks that have been assigned for non-barcoded controls. In this case no QC measurement is performed. The rack is passed through.
Requesting QC measurements manually
q Routine QC does not include QC measurement for standby reagents. To perform controls for standby reagents, QC measurement must be requested separately.
u
See Selecting tests for standby bottle QC (p. 464)
p To request controls for active reagents
1
Choose QC > Status .
2
Select the module where the QC is to be performed from the Module list box.
3
If routine QC is to be performed, choose Routine QC Assign to select all tests that are currently loaded on the system and activated for QC.
If individual QC is to be performed, select the desired module, test and control.
Multiple tests and controls can be selected.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 16-6 QC workflow—selecting individual QCs
A check mark appears in the Select column. Manual is displayed in the Cause column.
463
16 QC
Status submenu cobas® 8000 modular analyzer series
4 Choose Save to request the selected controls for measurement.
5 Load the controls onto the instrument as directed by the QC Load List and start the measurement.
u
For detailed information, see
To load required calibrators and controls (p. 281).
s
Selecting tests for standby bottle QC
q o Stand By Bottle QC can be requested on Calib. and QC Select window, even if the instrument is currently in Operation.
o Additional steps may be necessary if your cobas 8000 system is connected to a preanalytical system.
p To request controls for standby reagents
1
Choose QC > Status .
2
Choose Stand By Bottle QC to display the Stand By Bottle QC window.
Roche Diagnostics
464
Figure 16-7 Stand By Bottle QC window
3
Select the desired module, test and control. Multiple tests and controls can be selected.
A check mark appears in the Select column.
4
Choose OK to request the selected controls for measurement.
5
Load the controls onto the instrument as directed by the QC Load List and start the measurement.
u
For detailed information, see
To load required calibrators and controls (p. 281).
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Status submenu
Unloading auto QC racks from the auto QC compartment
q Expired controls in auto QC racks o If you use auto QC racks and the on-board stability set on the Utility > Application
> Range is exceeded for a control, the system issues a yellow alarm. Additionally on the QC > Status submenu, the * column (second column) of the corresponding control turns yellow in the Unloading window.
o Do not use expired auto QCs. Unload the concerned auto QC rack, replace the expired control, and reload the rack onto the instrument.
q Priority within control materials of the same kind o If there is more than one control of one lot available for a QC measurement, the system uses the control with the longest on-board stability.
q Automatic unloading of auto QC racks
Auto QC racks are unloaded automatically from the system if the Auto QC On-Board
Stability Time set on Utility > Application > Range is exceeded.
p To unload auto QC racks from the auto QC compartment
1
Choose QC > Status > Unloading .
2
In the Unloading window select the rack(s) to be unloaded.
3
Choose Execute .
s
Roche Diagnostics
Operator’s Manual · 4.2.1
465
16 QC
Run Status submenu
Run Status submenu
cobas® 8000 modular analyzer series
To display this submenu, choose QC > Run Status .
Figure 16-8 QC > Run Status submenu
The Run Status submenu displays the control results processed on the data manager.
Use the Run Status submenu to get an overview of the last 500 QC measurements performed on the instrument or to view the most recent QC measurements for one particular test specified.
Use the Test box to select all tests or one specific test to be displayed on the chart. Use the scroll bar at the bottom of the chart to move the focus from one result to the next.
Details area The Run Status submenu consists of a details area in the upper part of the screen and a chart in the lower part of the screen. The details area in the upper part of the Run
Status submenu displays the following information, which relates to the QC measurement selected on the run status chart.
QC results in the chart The indication of results in the chart is based on the standard deviation (SD): o
For clinical chemistry:
O Current QC ± 3 SD value range is displayed.
O
Standby Bottle QC ± 2 SD value range is displayed (default value).
o For immunochemistry:
O
Current QC ± 3 SD value range is displayed.
O Standby Bottle QC ± 3 SD value range is displayed (default value).
Chart symbols
Today
Today
Past day
Past day
QC result is outside the SD (High / Low) value range.
QC result is within the SD (High / Low) value range.
QC result is outside the SD (High / Low) value range.
QC result is within the SD (High / Low) value range.
Roche Diagnostics
466 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Run Status submenu
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Roche Diagnostics
Operator’s Manual · 4.2.1
467
16 QC
Controls submenu
Controls submenu
cobas® 8000 modular analyzer series
To display this submenu, choose QC > Controls .
Roche Diagnostics
468
Figure 16-9 QC > Controls submenu
Use the Controls submenu to view information about already registered controls and the current rack assignments.
If you are using controls without a barcode, you must assign each control to a rack number and position.
u
For information about particular tasks associated with this submenu, see:
Assigning control positions (p. 469)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
q If the Exp. Date column is highlighted in red, the corresponding control has expired.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Controls submenu
Assigning control positions
Use the following procedure to assign a control to a rack number and position if you are using cups without a barcode, or if the system cannot read the barcode on the control. This can be done only if the instrument is in Standby.
u
For more information about rack position assignment, see
q Do not use barcoded controls on racks that have been assigned for non-barcoded controls. In this case no QC measurement is performed. The rack is passed through to the rack unloading area.
p To assign racks and positions to controls
1
Choose QC > Controls .
2
Choose Rack Assign .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 16-10 QC > Controls > Rack Assign window
3
On the Rack Assign window, select the control from the list on the left.
4
Select an unassigned rack number and position from the list on the right.
5
Choose Add to register the new assignment.
6
To remove an existing assignment, select the corresponding rack number and position from the list on the right and choose Remove .
7
Choose OK to save the changes and to close the window.
s
469
16 QC
Install submenu
Install submenu
cobas® 8000 modular analyzer series
To display this submenu, choose QC > Install
Roche Diagnostics
470
Figure 16-11 QC > Install submenu
Use the Install submenu to download controls from the data manager or delete controls from the instrument. Furthermore, you can inactivate or activate tests for the controls.
q It is not possible to add a control manually to the instrument. The control data must always be downloaded from the data manager using the Download button. u
For details on the control data, for example, the target mean values, use the data manager component Control material .
The list on the left of the screen displays all controls installed on the instrument. Up to 100 controls can be installed on the system.
The list on the right of the screen displays whether the tests are assigned and activated to the control selected on the left.
u
For information about particular tasks associated with this submenu, see:
Inactivating and activating tests (p. 473)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Install submenu
Installing controls
Control data for available applications can be downloaded to the instrument from the data manager. u
For an overview of the complete installation process of a new application, see
Installing applications (overview) (p. 536).
Supervisors may download parameters for the newest and current release of an already installed control. Supervisors can neither download parameters for an older release nor parameters for a different control. Administrators may download any available control parameters.
Update control lot to newest release
Download current release of control lot again
Download different control lot for an already installed control (same material number)
Download any control and release
Table 16-4
Supervisor l l l
–
User rights for downloading control parameters l l
Administrator l l q If controls are used without barcodes, assign the control positions manually.
p To download control data from the data manager
1
Choose QC > Install .
2
Choose Download to display the corresponding window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 16-12 Download window
3 Select the control to be downloaded. You may use one of the search options: o All Items : Select the control directly from the list of all controls. o
Required Item : This search option lists all controls that are on board but for which the control information was not yet downloaded.
o Control : Select the control name from a list box.
o
Lot ID : Enter the control number in the text box.
471
16 QC
Install submenu cobas® 8000 modular analyzer series
4 Choose Search to start searching for the selected criteria. The search results are displayed in the Result area.
5 Select the check box of the control to be downloaded.
6 Choose Download to display the Confirmation window.
Roche Diagnostics
472
Figure 16-13 Confirmation window
The Confirmation window shows the module types for which the control is available (the material and lot number must be identical).
7 Check and complete the settings displayed in the Confirmation window: o
The Current Release Date refers to the control lot currently on board. This is only available if the same control lot is requested for download.
o The Addition Release Date shows the release that will be newly installed.
Administrators may select other available releases (the newest one is always on top).
Select None from the list box if you want to skip downloading the parameters for a specific module.
o The Update Release Date is similar to the Addition Release Date , but will only be displayed if an existing control is updated.
8 Choose OK to confirm the settings and to download the control.
The window is grayed out for a moment until the download is finished.
All necessary information, such as applications covered by the control, target mean values, and target SD values, is automatically stored by the system.
9 Choose Close to return to the QC > Install submenu and verify that the downloaded information has been registered correctly.
10 To run tests with a newly installed control, it is necessary to activate these tests.
u
See
Inactivating and activating tests (p. 473).
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 16 QC
Install submenu
Inactivating and activating tests
All tests on board are automatically activated once the controls are installed. Tests can only be inactivated (or activated again) when the instrument is in Standby.
p To inactivate tests
1
On the QC > Install submenu, choose the appropriate control name in the list box on the left side of the screen.
2
Choose the test to be inactivated from the list on the right of the screen. An activated test is highlighted in blue.
3
Choose Inactivate Test .
4
Repeat steps 2 and 3 for all tests to be inactivated for that control.
s p To activate tests
1 On the QC > Install submenu, choose the appropriate control name in the list box on the left side of the screen.
2 Choose the test to be activated in the list on the right of the screen.
3 Choose Activate Test . The test name highlights in blue when the test is activated.
4
Repeat steps 2 and 3 for all tests to be activated for that control.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
473
16 QC
Install submenu cobas® 8000 modular analyzer series
Roche Diagnostics
474 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Extended operation
Using various functions
17 Extended operation
17
This chapter contains additional information and tasks which are usually not required during normal routine operation.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
17
Operating the instrument in rack and position mode ........................................... 486
475
17 Extended operation
Table of contents cobas® 8000 modular analyzer series
Measuring samples in Backup Operation mode..................................................... 499
Unloading racks and switch off Backup Operation mode .............................. 501
Roche Diagnostics
476 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Instrument statuses (modes)
Instrument statuses (modes)
Status or mode is used as a general term to refer to the current status of the instrument. The instrument status is always displayed at the top left of the screen.
Figure 17-1 Current instrument status
The following table shows the most important statuses:
Status
Power Up
Initialize
Standby
Preparation
Explanation
Status while the instrument is loading programs, performing self-checks etc.
Status after power up while the instruments performs any kind of initialization.
Status when the instrument does not perform any measurement activities.
Status while the instrument prepares the modules for
Operation. This includes electrode conditioning, cuvette washing, micro bead mixing, etc.
Operation
Rack Collect End
Status while the instrument is pipetting, measuring, or calculating.
Status indicates that sample pipetting is finished and all racks are collected in the unloading area.
Rack Reception Mode
Rack Supply Complete
Maintenance
Post Operation
E.Stop
S.Stop
Table 17-1
After all test requests are completed, the instrument waits for additional samples. New samples will be processed automatically after pressing the Start button.
Status indicates that all racks are transported to the modules and MSBs. No more racks are in the loading area.
Status while the instrument is performing any softwarecontrolled maintenance item or check.
After the Rack Reception Mode has elapsed, finalization of the e 602 modules is performed before the instrument enters
Standby. Finalization includes rinsing and preparation steps to allow e 602 modules to stand unused for several hours.
Status indicating that the system has performed an emergency stop due to hardware failure or because any of the safety devices requested an emergency stop. The system requires either a complete power off or at least a reset ( Utility
> Maintenance ) to resume normal operation.
After pressing the S.Stop
button, the status changes to
Sampling Stop . The samples in racks on the analyzer modules will be completed and then moved to the rack unloading area.
Samples in the rack loading area and the module sample buffers will no longer be processed and moved to the rack unloading area directly. When all racks have been moved to the unloading area, the instrument goes into Standby.
Statuses (modes)
Roche Diagnostics
Operator’s Manual · 4.2.1
477
17 Extended operation
Masking functions
Masking functions
cobas® 8000 modular analyzer series
Generally speaking, masking is a function that allows temporary exclusion of the masked element from analysis. Some types of masking are set automatically by the instrument depending on specific conditions, other types are manually set by the user.
The following table provides an overview of the masking functions:
Masking function
Test masking and
Patient masking
Use
To disable analysis of a test or sample, e.g., until calibration or QC is performed
Module masking
To disable a single module for background maintenance or for loading of reagents
Reagent masking
To disable analysis of a test if a required reagent is empty (red alarm)
Reagent pack masking
Calibration masking
(Auto. masking)
To exclude a specific reagent pack from analysis temporarily
To disable analysis of tests whose calibration is failed or invalid until calibration is performed successfully
Masking from data manager
Table 17-2
Test masking and patient masking can be set directly from the data manager
Masking functions
Notes
Manual
(1)
Manual
Automatic
Manual
Automatic
(if configured)
Manual
Page
(1) On the data manager, an automatic patient masking can be configured (component: Test mask overview ).
q Masked tests can be requested but not measured until the test is unmasked. Masked tests are indicated on the Workplace > Test Selection submenu.
u
See Test selection matrix (p. 302).
Test masking and patient masking
You may use test masking and patient masking to exclude specific tests from the current analysis.
There are two methods to mask a test on the instrument: o
If Test Mask is selected, no patient samples, no controls, and no calibrations can be performed.
o
If Patient Mask is selected, the test is masked for patient samples only—calibration and QC can be performed.
Tests can be masked completely or just for specific modules and measuring channels.
Masking tests on specific modules or measuring channels may be reasonable, for example, at times with reduced throughput (evenings, weekends) in order to save calibrators, controls, and time.
u
For a detailed description of the Masking window, please refer to the Online Help.
Roche Diagnostics
478 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Masking functions q In addition to manual masking on the instrument, an automatic patient masking can be configured on the data manager.
u
For more information, please refer to the data manager component Test mask overview in the Operator’s Manual or the Online Help of the cobas 8000 data manager. p To mask a test
1 Choose Start (global button) > Masking .
The Masking window shows the registered tests in the left column, the other columns represent the reagent disk or measuring channels of the modules.
On c 701 / c 702 modules, the two reagent disks are displayed as separate measuring channels. So a test can be masked on one reagent disk, while it remains available on the other disk.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 17-2 Masking window
2
Mask a test completely, or just for an individual measuring channel: o
Select a test in the Test column to mask it on all modules.
or, o
Select a test key in one of the other columns to mask it on this channel.
3 Choose the test key repeatedly to toggle between T.Mask
, P.Mask
and Unmask .
4 For e 602 modules: If a test is masked on one measuring channel, select the Mask on scheduling within module check box to allow the system to change the test assignment to the other channel of the same e 602 module.
s
479
17 Extended operation
Masking functions
Module masking
cobas® 8000 modular analyzer series
You may use the module masking function to disable an individual module. A masked module goes into Standby. Certain maintenance items can be performed on a masked module while the other modules are still processing samples. This is called background maintenance .
For loading reagents, the ISE, c 701 and e 602 modules must be in Standby. Module
Masking allows loading of reagents on one module while the others are operating.
u
For detailed instructions, see:
Performing background maintenance (module masking) (p. 626)
Reagent masking
When a reagent is used up, the system issues a yellow alarm and a red bar is displayed on the test key on the Test Selection submenu. Tests that require this reagent are masked by reagent masking—unless another reagent pack is available as a standby reagent.
o
Reagent masking is applied to:
O
Photometric and immunologic assay reagents
O
ISE reagents
O
Pretreatment
O
Diluent if part of an immunoassay o
Reagent masking is NOT applied to:
O
Reaction cell detergents (CellCln 1 and CellCln 2)
O
Diluent for the dilution of samples or for the dilution of photometric assays
O
Reagent probe detergents D1 and D2
O
Ecotergent
If a reagent is masked The test will be unmasked automatically as soon as you load a new reagent. After registration, check the reagent volume, number of available tests, etc., on Reagent
> Setting .
q Rerun required in case of reagent masking
A rerun is required for samples whose sampling was terminated by reagent masking. Take the sample rack concerned from the unloading area, place it into the rack loading area, and perform a rerun measurement. These samples will be shown as masked ( M ) in the
Test Review window.
Other causes for reagent masking Reagent masking may also occur in the following cases: o
On e 602 modules: If a reagent has been open for a long time during operation, there might be a risk of evaporation. Then the test will be masked. When the system goes into Standby, the masking is automatically removed.
o
On c 701 / c 702 modules: Foam was detected on the surface of the reagent.
o
On e 602 modules: Foam was produced during mixing by the microbead mixer.
Roche Diagnostics
480 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Masking functions
Remedy o
Check if an alarm referring to evaporation or foam was issued. Follow the remedy description.
o
Check Workplace > Data Review > Test Review if the status M (masked) is indicated.
u
For an explanation of the status M on the Test Review window, see
Viewing the status of controls on the Test Review window (p. 319).
o
Remove and discard this reagent pack.
o
If foam was detected: Remove this reagent pack briefly until the foam is gone.
o
Call technical support if the microbead mixer produces foam repeatedly.
Reagent pack masking
On all modules except the ISE module, you may exclude test reagent packs from analysis temporarily. Special reagents, diluents, detergents, and pretreatment reagent packs cannot be masked.
Masking of a reagent pack makes sense, for example, when a calibration or QC issue occurred. When this reagent pack is masked, you can continue working now and troubleshoot later on.
q o A reagent pack can be masked in any status of the instrument. The module must be in
Standby to unmask a reagent pack.
o Calibration and QC are not possible for masked reagent packs. Masked reagent packs are removed from Calibration and QC menus.
o If the reagent pack is part of a reagent pack set ( c 701 / c 702), the reagent pack pair is also masked or unmasked.
p To mask a reagent pack
1 Choose Overview .
2 Select the Reagent Overview button for the desired module.
3 Select the reagent pack to be masked.
4 Choose Detail .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 17-3 Detail window of c 701 module is used as example
481
17 Extended operation
Masking functions cobas® 8000 modular analyzer series q
5 Choose R. Pack Mask to mask the selected reagent pack.
The analyzer stops using this reagent pack as soon as possible. It may take up to
30 seconds until a reagent pack is masked. Masking is, in principle, not applied to pipetted samples. o Masked reagent packs are indicated like empty reagent packs on the Reagent
Overview window and the Reagent menu. If no other reagent pack for this test is available, masked reagent packs are highlighted red.
o If there is another reagent pack for the same test, sample pipetting is continued without masking this test.
s p To unmask a reagent pack
1
Make sure that the module is in Standby.
2
Choose Overview and select the Reagent Overview button for the module.
3
Select the reagent pack and choose Detail .
4
Choose R. Pack Unmask to make this reagent pack available again.
s
Calibration masking (auto masking)
The Auto Masking function masks a test if no valid calibration is available for the corresponding reagent pack. The test can be masked separately for each particular module ( c 502), reagent disk ( c 701 / c 702), or measuring channel ( e 602).
There are two cases where no valid calibration is available: o
Failed calibrations o
Invalid calibrations (in case of a changeover calibration request) u
For more details, see Calibration masking (auto masking) (p. 417).
The Auto Masking function can be activated or deactivated for the entire system under Utility > System > Calib. and QC Settings . When activated, the function can be selected individually for each application on Utility > Application > Calib .
u
For information about the settings, see:
Calibration Settings (Auto. Masking) (p. 525)
Calibration masking (application-specific) (p. 555)
Masking from the data manager
Test masking and patient masking can be set directly from the data manager.
If a test is masked on the data manager, the masked status is reflected on the control unit at the same time.
u
For more information, please refer to the data manager component Test mask overview in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
Roche Diagnostics
482 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reports
17 Extended operation
Reports
This section explains how reports can be printed or archived on DVD media.
Printing reports
The Print window allows selection of all reports for printing. The general process is the same for all reports.
q For some reports, you must enter specific parameters prior to printing. For example, if you want to print a Result List , select the results to be printed on Workplace > Data Review before you start with the following procedure.
u
For a detailed description of all reports, please refer to the Online Help.
p To view and print a report
1 Choose Print (global button).
2 Select the appropriate tab ( Workplace , Reagent , Calibrator , QC , or Utility ).
3 Select the report to be printed from the list.
4 Select the desired options in the center of the screen, if required.
5 Choose Preview .
The icon on the Print button starts flashing.
6 When the icon has stopped flashing, choose History .
A preview of the report printed last is displayed on the right. The list on the left shows the recently printed reports.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 17-4 History window
7 Use the buttons below the preview to navigate through the pages of the report.
8 To print the selected report, choose Print Out .
483
17 Extended operation
Reports
Archiving reports
Use this function to make backup copies of reports on a storage medium (DVD).
q Please note that DVD media must be prepared prior to use.
u
See: Preparing DVD media for backups (p. 502)
p To archive a report
1
Choose Print (global button) > History .
2
Insert a DVD into the DVD drive of the control unit.
3
Select the reports to be archived from the list and choose Backup .
s
Deleting reports
cobas® 8000 modular analyzer series
9 On the Print Range window, select the pages to be printed.
u
For information on printing specific reports, see:
To print a Reagent Load/Unload List (p. 278)
To request calibration and QC and to print load lists (p. 281)
To print a Maintenance Report (p. 610)
s
By default, reports remain available after power-off.
If desired, reports can be deleted automatically with the shutdown of the system.
Select the Data Initialization check box on Utility > System > Print Settings .
q Delete unused reports regularly in order to keep the number of reports in the History list to a manageable level.
p To delete reports manually
1 Choose Print (global button) > History .
2 The History window allows deletion of single reports or all reports: o
Select all reports to be deleted from the list and choose Delete . or, o
Choose Delete All to delete the complete list of reports.
s
Roche Diagnostics
484 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Connection to a CLAS
Connection to a CLAS
The instrument can be connected to a CLAS (clinical laboratory automation system) like the MODULAR PRE-ANALYTICS (MPA) or the cobas® 8100 automated workflow series.
Figure 17-5 The cobas 8000 instrument connected to an MPA
Depending on the installed modules, a CLAS can take over time-consuming pre- and post-analytic tasks, such as: o
Sort and centrifuge samples o
Aliquot samples for connected analyzers o
Aliquot secondary tubes for other targets o
Print barcode labels and label the sample tubes o
Archive samples q Only Roche service personnel is authorized to install and configure the CLAS connection.
CLAS connection indicator field If the cobas 8000 system is connected to a CLAS, this field on the Overview menu displays the status of the connection.
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A CLAS connection indicator field
Figure 17-6 Module Overview area on the Overview menu
485
17 Extended operation
Connection to a CLAS cobas® 8000 modular analyzer series
Color Meaning
Connection to CLAS (clinical laboratory automation system) or the CLAS itself is in an error status above caution level.
Red
Connection to CLAS or the CLAS itself is in an error status of caution level.
Yellow
CLAS connection online
Light blue
CLAS connection offline (e.g., disabled in Start window)
Table 17-3
Gray
Colors of the CLAS connection indicator field
Operating the instrument in rack and position mode
The CLAS interacts with the LIS and the data manager. Therefore, the sample processing differs slightly from operation without a CLAS.
q Routine and STAT samples o Samples from the CLAS do not necessarily need a barcode. The test selection is transferred to the instrument using the rack number and position number.
Nevertheless, barcodes allow the identification of samples throughout the workflow, e.g., for rerun and archiving.
o Racks are transported from the CLAS to the instrument via the STAT port. This port is called B-gate in case of a connection to a CLAS.
o For STAT samples, red STAT racks must be used. STAT racks can be placed into the rack loading area of the core unit.
p To process samples in rack and position mode
1 At the LIS, select the required tests using the sample ID, rack number, and position number.
2 Load samples onto the analyzer via the CLAS (or load STATs directly into the rack loading area).
3 Choose Start (global button) to start the measurement.
The control unit now queries the test selection from the LIS with rack number and position number.
s
Roche Diagnostics
486 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Setting the date and time
Setting the date and time
This section describes how the system date/time and the time switch in the core unit are set.
Set the date and time of the system
Use the following procedure to set the present date and time of the system.
The date and time of the instrument must be set in accordance with the data manager and in the specified order.
p To set the present date and time
1
Change the date/time setting in the data manager.
u
Please refer to the Operator’s Manual or the Online Help of the cobas 8000 data manager.
2
Choose Utility > System > Display Settings to change the date/time setting of the control unit.
Figure 17-7 Display Settings window
3
Set the corresponding Set Date/Time text boxes and confirm with OK .
4
Power the analyzer off and on again.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
487
17 Extended operation
Setting the date and time
Set the digital time switch
cobas® 8000 modular analyzer series
The instrument can be programmed for automatic start-up with the time switch on the front panel of the core unit.
The Timer toggle switch on the front panel of the core unit must be set to the ON position to enable the time switch.
A
B
C
A Time switch
B Lid
Figure 17-8
C Timer toggle switch
Front panel of the core unit
This section shows two examples for programming an automatic start-up: o
The first example explains how to set the weekday and time to Wednesday, 15:20 u
See
To set the present day and time (p. 489)
o
The second example explains how to set the start-up time to 8:30 a.m.
for Monday through Friday u
See
To set the start-up time for each day of the week (p. 490)
Roche Diagnostics
488 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Setting the date and time p To set the present day and time
1 Open the front panel of the core unit.
2 Set the TIMER toggle switch to the OFF position while you are programming.
3 Open the lid at the bottom of the time switch.
A
B
A MODE switch (P1, P2, RUN)
B Day keys
Figure 17-9 Time switch
C D
C OUT switches
D OUT1 and OUT2 switches q o Check that the OUT switches (
) behind the lid are always set to PULSE.
o Check that the OUT1 and OUT2
) are always set to AUTO.
4 Set the MODE switch to RUN .
5 Press TIME ADJ for 2 seconds or longer. The clock symbol flashes.
6 Press the WED day key (or any other day key). The bar (–) mark at the corresponding day key turns on.
7 Set the time by pressing the h and min keys.
Holding the keys down rapidly increases the value. To decrease the value, press the Holiday/Down key.
8 Press WRITE to save the settings. The new day and time are set.
Now you can set the start-up time for each day and activate the time switch (see next procedures).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
489
17 Extended operation
Setting the date and time cobas® 8000 modular analyzer series p To set the start-up time for each day of the week
1 Set the MODE switch to P1 .
o
If one or more programs have already been set, these programs are displayed.
o
To add another program, press WRITE repeatedly until --:- is displayed.
2
Press the day keys to turn the bar (–) marks on or off: o
If the instrument should start up on each weekday except Sundays: Press the
SUN key to turn off the bar at the position of Sunday.
or, o
Individual selection of start-up days: Press the day keys to turn on the bar marks at the positions of the days for which you want to set the start-up time.
3 Set the start-up time by pressing the h and min keys. Press WRITE to save the setting. q Automatic power-off
The instrument cannot be powered off by the time switch!
o Power off the instrument manually or use the Power Off Pipe function.
u
See
Power Off Pipe function (p. 601).
4
Press the min/Pulse key to increase the displayed pulse duration value to 5s .
This sets a time delay of 5 seconds between the activation of the timer and the execution of start-up.
5
Press WRITE to confirm the setting.
Now you can activate the time switch (see next procedure).
s p To activate the time switch
1 Set the MODE switch to RUN .
2 Close the small lid on the time switch.
3 To activate the timer, set the TIMER toggle switch to the ON position.
4 Press the orange Operation Power OFF button at the front of the core unit.
The instrument will start up automatically at the set time. After start-up, the instrument can automatically perform maintenance items if the Power Up Pipe function is configured. u
For information on how to select a Power Up Pipe function, see:
Power Up Pipe function (p. 599).
q Using the automatic start-up
Always check the following prior to the automatic start-up: o Check the main water supply is turned on.
o Ensure the instrument inspection was already performed after the last power off.
u
See
Instrument inspection (p. 294).
s
Roche Diagnostics
490 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Setting the date and time
Check timer programming
Example: Check the set start-up time for Fridays.
p To check timer programming
1
Set the MODE switch to RUN .
2
Press the FRI key for at least 2 seconds.
3
Check the earliest start-up time displayed after the CHEC indication flashes.
4
Press the WRITE key to display the pulse duration value. Check that it is set to 5s .
5
Press the WRITE key again. END is displayed.
6
Check that the display returns to the initial state afterwards.
s
Set holidays
This procedure is used to set any exceptions from the regular program, for example, for public holidays.
q It is possible to set holidays for up to 6 days in advance.
After the set day is passed, the setting is cleared automatically.
Example: Set a holiday for this Friday only.
p To set holidays
1
Set the MODE switch to RUN .
2
Press the Holiday/Down key for at least 2 seconds. The holiday setting mode starts.
3
Press the FRI key to turn off the bar (–) mark at the position of Friday.
4
Press WRITE to confirm the setting. s
Clear timer programming q It is not possible to clear the program for single days.
p To clear a single setting
1 Open the lid at the bottom of the time switch.
2 Set the MODE switch to P1 .
3 Press WRITE repeatedly to select the program to be deleted.
4 Press CLEAR briefly. The display indicates CLR - STEP .
5 Press WRITE to clear the settings. To cancel the clearing operation, press CLEAR while CLR is displayed.
6 Set the MODE switch to RUN .
s
Roche Diagnostics
Operator’s Manual · 4.2.1
491
17 Extended operation
Setting the date and time cobas® 8000 modular analyzer series p To clear all settings
1 Open the lid at the bottom of the time switch.
2 Set the MODE switch to P1 .
3 Press CLEAR for at least 1 second. The display indicates CLR - ALL .
4 Press WRITE to clear the settings. To cancel the clearing operation, press CLEAR while CLR is displayed.
s
Roche Diagnostics
492 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Processing reruns
Processing reruns
Rerun samples can be processed in two ways: as automatic reruns or as manual reruns.
Automatic reruns
If a test result is flagged with a data alarm (e.g., the result is outside the technical limits, >Test / <Test alarm) and the automatic rerun function is activated, this test will be measured again.
Automatic reruns can be performed for most of the data alarms, except for some alarms according to the rerun list. u
For information on data alarms that can cause an automatic rerun, see:
q Automatic reruns can be activated for all tests or for specific applications: o Automatic reruns can be activated for all tests ( system-wide setting ) in the Start window.
o By means of the application-specific setting you can exclude tests from the automatic rerun ( Utility > Application > Range ).
The following table shows the cases in which an automatic rerun will be performed for a specific test if the result of this test is flagged with a data alarm:
Automatic rerun setting
System-wide Application-specific
YES
YES
NO
YES
NO
YES is requested l l (1) l (1)
Rerun is performed l
–
–
NO NO l (1) –
Table 17-4 Correlation between the system-wide and the application-specific rerun setting
(1) The sample status changes back to Ordered (O) . A rerun can be performed by restarting the measurement.
q If a result is flagged with a data alarm, a rerun is requested automatically and irrespective of the system-specific and application-specific settings. Only if both settings are enabled is a rerun of this test performed automatically.
Application-specific setting Automatic reruns are performed depending on whether the Automatic Rerun check box on Utility > Application > Range is selected or not for each test. If it is, the test is automatically requested for rerun and remeasured whenever a result is flagged with a specific data alarm according to the rerun list.
u
For information on using the application-specific rerun setting, see:
Automatic Rerun (application-specific) (p. 558)
System-wide setting The system-wide setting is displayed in the Automatic Rerun area on the Start window.
Roche Diagnostics
Operator’s Manual · 4.2.1
493
17 Extended operation
Processing reruns cobas® 8000 modular analyzer series p To activate the automatic rerun function (system-wide)
1 Choose Start (global button).
2 Choose Change in the Automatic Rerun area to verify the system-wide rerun setting.
Figure 17-10 Automatic Rerun window
3
Select the Routine check box or STAT check box (or both) to process reruns without operator intervention.
4
Choose OK to save the setting.
5
Choose Cancel to close the Start window.
s
Manual reruns
If Automatic Rerun is set to NO in the Start window, all reruns are to be processed manually (regardless of application-specific settings).
u
For information about performing manual reruns, see:
Performing manual reruns (p. 308).
Sample volumes for reruns
If you manually predilute a sample before you reload it onto the instrument, make sure to select the Pre-dilution check box on Workplace > Test Selection .
Tests that need to be rerun can be measured with normal, decreased, or increased sample volumes or with diluted samples.
Normal sample volume
Decreased sample volume
ISE module l
–
Increased sample volume
Diluted sample
Table 17-5
–
–
Available dilutions for reruns
Photometric modules l l l l e 602 module l l
– l
(1)
(1) If decreased is selected in the Test Selection submenu and in the data manager, the dilution ratio defined on Utility > Application > Range is used.
These dilutions, performed by the instrument, can either be programmed to be performed automatically, they can be requested manually by the operator, or they can be requested by the LIS (host).
Roche Diagnostics
494 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Processing reruns u
Refer to the Instructions for Use of the respective application for recommended dilutions.
q Make sure that sufficient module-specific diluents are loaded to dilute samples.
Automatic dilutions Individual tests can be configured with a dilution for rerun. The instrument automatically performs and calculates dilutions defined in the instrument software.
Administrator access is required to define these dilution parameters ( Utility
> Application submenu).
Manually requested dilutions You may also request the dilution manually. Choose the Sample Volume / Dilution box on Workplace > Test Selection and select Decrease , Increase , or a dilution ratio.
Available dilution ratios: o
For photometric assays: From 1:3 to 1:50 o
For immunoassays: From 1:2 to 1:400 q o The option 1:1 from the Sample Volume / Dilution list box is used to override the preconfigured first run dilution.
o When using dilution ratios different from the recommended ratios for the application, you must validate the dilution behavior of the application.
q System automatically selects the higher dilution ratio
In the following case, the dilution ratio used in the first run (e.g., 1:10) and the dilution ratio defined in Utility > Application > Analyze for the rerun (e.g., 1:2) are compared with each other: o The first run was measured with a manually requested dilution, and o The data alarm >Test was generated and caused an automatic rerun.
In this case, the dilution ratio of the first run is higher than the application setting for rerun.
The rerun measurement is automatically performed with the higher dilution ratio (1:10).
u
For information on manual test requests, see
Requesting a test manually (p. 304).
Request from the data manager or the LIS
Dilutions can also be requested by the data manager or the LIS. In this case, the samples are in the rack unloading area and have to be reloaded and processed again.
u
For information on requesting dilutions from the data manager, please refer to the component Host backup in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
Roche Diagnostics
Operator’s Manual · 4.2.1
495
17 Extended operation
Processing reruns
Prediluted samples
cobas® 8000 modular analyzer series
Manually prediluted samples are samples which have been prediluted before they were put on the instrument. (These are not to be confused with manually requested dilutions.) q Samples which have been manually prediluted can be measured, but the corresponding dilution factors are NOT taken into consideration when the results are calculated by the system. It is the operator's responsibility to calculate the final results.
For manually prediluted samples, make sure that you first select the Pre-dilution check box on Workplace > Test Selection . When the Pre-dilution check box is selected, results are flagged with P on the printed monitor report and there is a mark in the Dil.
columns on Workplace > Data Review and on Workplace > Data Review
> Test Review , too.
Roche Diagnostics
496 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Backup Operation
Backup Operation
The Backup Operation mode can be useful if the rack loading/unloading area or the transportation line cannot convey any samples. This mode enables sample measurement on modules to continue.
In Backup Operation mode, only routine and STAT samples can be processed
(including rerun samples). q o Backup Operation mode is available only if barcode mode is selected.
o Backup Operation mode is available on all modules at a time.
Activating Backup Operation mode
p To activate the Backup Operation mode
1 On the Overview menu, select the button of the module sample buffer of the module where the samples should be processed.
Figure 17-11 Overview menu
The Module window for the corresponding module sample buffer is displayed.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 17-12 Module window – module sample buffer
2 Choose Backup Operation .
497
17 Extended operation
Backup Operation cobas® 8000 modular analyzer series
3 When the instrument goes into Backup Operation status, the instrument is ready to measure samples. u
See
Measuring samples in Backup Operation mode (p. 499)
4 Choose Utility > System > Rack Delivery .
Figure 17-13 Rack Delivery window
5
From the Backup Operation Sample Height list box, select the container type to be used for backup operation mode.
This is required because the container height cannot be detected in backup operation mode.
s
Roche Diagnostics
498 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Backup Operation
Measuring samples in Backup Operation mode
Similar to routine operation, tests can be selected either from the Test Selection submenu or via data manager.
In this mode, you must place the sample racks into the backup operation port at the front of the corresponding module sample buffer.
q Backup operation on c 702 modules
The preparation table at the module sample buffer must be removed to use the backup operation port.
u
See: Backup operation port (p. 150)
A B
A Module sample buffer
Figure 17-14
B Backup operation port
Backup operation port (all modules except c 702)
Before performing the following actions, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Incorrect results and interruption of analysis due to contaminated samples (p. 31)
r
Infection and injury due to contact with instrument mechanism (p. 229)
r
Interruption of operation due to interlock system (p. 230)
Roche Diagnostics
Operator’s Manual · 4.2.1
499
17 Extended operation
Backup Operation
NOTICE
NOTICE cobas® 8000 modular analyzer series p To measure samples in Backup Operation mode
1 Activate the Backup Operation mode.
u
See
To activate the Backup Operation mode (p. 497)
2 If you need a list of samples to be loaded (batch mode), choose Print (global button) > Workplace > Requisition List .
3 Prepare gray routine racks or red STAT racks with rack numbers according to the sample types (such as Ser/Pl, Urine, CSF…).
Property damage when using a wrong sample container
During backup operation, the sample container height cannot be detected but must be set manually. If a sample container is used that does not match the set container height, the sample probe may crash into the container. This may damage the probe and / or the container.
r During backup operation, be sure to use only the type of sample container specified in the Rack Delivery window.
4
Place samples into the racks. Ensure sample barcodes are facing the open slot in the rack so the barcode reader can scan them.
5
Before loading a routine rack or STAT rack into the backup operation port, check that the green status LED is on.
Instrument damage when a rack is inserted wrongly
The instrument normally issues an alarm if a rack was inserted wrongly in the backup operation port. However, under certain circumstances a wrong rack direction cannot be detected, which may possibly lead to instrument damage.
r Ensure the correct orientation of the rack.
r Align the rack to the right and the rear side of the backup operation port.
6 Ensure the correct orientation of the rack and align it to the right.
7
If more than one rack should be measured, repeat steps 3 to 6
for up to 20 racks.
8 Close the cover of the backup operation port.
9 Choose the Backup Analyze button on the Module window to start the processing.
s
Roche Diagnostics
500 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 17 Extended operation
Backup Operation
Unloading racks and switch off Backup Operation mode
After all test requests are completed, sampling stops and the Backup Collect button in the Module window is available. You can now unload racks and switch off the
Backup Operation mode.
p To unload racks in Backup Operation mode
1
Choose the Backup Collect button for unloading racks from the backup operation port.
2
Before unloading a rack from the backup operation port, check that the green status LED flashes.
3
Repeat step
2 for all racks in the module sample buffer.
4
To perform continuous measurement, load the next racks to be measured into the backup operation port and choose Backup Analyze .
u
See
To measure samples in Backup Operation mode (p. 500).
5
until all samples are measured.
6
Switch off the Backup Operation mode, after all samples are measured.
u
See
To switch off the Backup Operation mode (p. 501).
s p To switch off the Backup Operation mode
1
Choose Overview .
2
Select the button of the module sample buffer for which you want to stop the
Backup Operation mode. The Module window is displayed.
3
Select Cancel Maintenance . The corresponding window is displayed.
4
Confirm with OK .
The module returns to Standby.
q You may also choose Stop (global button) to switch off the Backup Operation mode but this would stop all functions on all modules.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
501
17 Extended operation
Preparing DVD media for backups
Preparing DVD media for backups
cobas® 8000 modular analyzer series
The cobas 8000 control unit computer is equipped with a DVD drive. The DVD drive can be used for installing software updates and backing up and restoring data. q Only packet writing is used in cobas 8000 instruments o The cobas 8000 instrument uses the packet writing method to store data on DVDs.
This method allows files to be copied and erased immediately to/from a DVD, as if it were a floppy or USB flash drive.
o In contrast to common DVD burning methods , packet writing is more convenient for regular backups because files can be copied immediately without having to burn them.
o To support packet writing, each DVD must be formatted before use.
u
Media types The following media types can be used:
Media type Explanation
DVD+R
(recordable media)
Each burn is permanent. When using packet writing, you can delete unwanted files from R media, but this does not free up the occupied storage space (the space becomes inaccessible instead). It is not possible to reformat and rewrite R media.
If you perform backups repeatedly without removing the
DVD from the control unit, R media can be used.
DVD-RW, DVD+RW
(rewritable media)
DVD-RAM
(random-access memory media)
Table 17-6
You can delete unwanted files from RW media to free up storage space.
If you want to use a disc in other computers and then add more backups at the control unit, RW media are required.
DVD-RAMs have the same features as DVD+/-RWs, but have some advantages that make them very interesting for data backups: High reliability, disc defect management, long life, and they can be rewritten over 100 000 times.
DVD-RAMs can only be read in DVD-RAM drives.
Media types compatible with the cobas 8000 instrument q General recommendations
The quality of DVD media varies by manufacturer. For reliable data backups, we recommend selecting the major manufacturers.
We also recommend that you handle DVD media with care.
We do not recommend the use of CDs because of some known incompatibilities.
q Recommendations when executing a backup
Do not start a data backup just after a DVD was inserted (as long as the access lamp is still blinking). Do not shut down the instrument before the DVD is removed from the PC.
Otherwise, the data backup may not be executed correctly.
Roche Diagnostics
502 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Formatting DVDs
NOTICE
17 Extended operation
Preparing DVD media for backups
DVD+R media can be formatted once only. DVD+/-RW, and DVD-RAM media can be formatted several times.
Danger of data loss
Formatting deletes all data on the medium.
r Before formatting, make sure that no important data is stored on the DVD.
q o The media must be formatted with UDF (Universal Disc Format) Version 2.0. o Only use the cobas 8000 control unit computer for formatting. The control unit computer may not be able to read a DVD formatted on other computers.
p To format a DVD
1
Make sure the analyzer is in standby.
2
Insert the DVD into the drive. Wait until the access lamp turns off.
3
Press Ctrl+F7 to display the Format (Option) window.
4
Choose Quick Format and confirm with OK . (Depending on the media type, only Full is available.)
The DVD will be formatted. This may take several minutes.
5
Wait until the dialog box disappears.
The DVD is ready for a data backup now.
u
For an overview about the data types for backup, see:
Archiving data and performing data backups (p. 504)
q Finalization not required
It is not necessary to make the DVD compatible for other computers. This is done automatically when the medium is removed from the drive of the cobas 8000 instrument.
Note that the DVD might not be readable on operating systems prior to Windows XP.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
503
17 Extended operation
Archiving data and performing data backups cobas® 8000 modular analyzer series
Archiving data and performing data backups
Data type
Test results
(patient data)
Important data, configurable
(1)
Backup function
(daily)
System parameters Backup after
(re)programming
The instrument software manages several types of data and provides the following storage routines. DVDs can be used as storage media.
Storage routine
Sending/Archiving after measurement
Target o to the data manager o to a storage medium to the data manager to a storage medium
To be performed automatically (or manually via Workplace > Data Review
> Sent to DM ) via Workplace > Data Review > Backup Data , or via Overview > Sample Data Clear > Backup And Clear via Essential Information Upload
(can be performed automatically by a maintenance pipe) via Utility > Maintenance > Parameter Read/Write
Reports Backup to a storage medium via Print > History > Backup
Table 17-7 Overview of data types and possible storage routines
(1) The data types to be stored on the data manager are configured by Roche service personnel during installation (e.g., calibrator and control data).
NOTICE Data loss due to erroneous operation or instrument problems r Back up your data (measurement results and system parameters) at regular intervals.
Minimizing the risk of data loss
p To minimize the risk of data loss, perform the following routines:
1 Make sure that all test results are archived on the data manager or the LIS (or on both). Additionally you can make backup copies of the results on DVDs.
u
For more information, see:
Archiving patient data (p. 321)
2 We recommend using the backup function in a daily maintenance pipe to store relevant data on the hard disk of the data manager. u
For more information, see:
(26) Essential Information Upload (p. 618)
3 Make a backup copy if you have changed any system parameters (e.g., application
parameters, see table 18-1, p. 508).
u
For more information, see:
Saving system parameters (p. 532)
s
Roche Diagnostics
504 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Utility
Configuring the instrument
18 Utility
18
This chapter describes the configuration of the cobas 8000 instrument.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
18
Setting a yellow / initial loading limit (cobas c 702 module).......................... 531
505
18 Utility
Table of contents cobas® 8000 modular analyzer series
Installing the Hemoglobin A1c whole blood application (c 502)......................... 544
Installing and configuring the HbA1c application........................................... 545
Installing the serum index application (photometric modules) ........................... 549
Programming a special wash (photometric modules) ........................................... 565
Programming a special wash (cobas e 602 module)............................................... 570
Roche Diagnostics
506 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
System submenu
This section explains how to perform certain tasks associated with the Utility
> System submenu.
q The entire module set (module configuration, test assignment) should be set up before the other settings (control, calibrator settings) u
For more information on configuring the modules, see System Configuration submenu
To display this submenu, choose Utility > System .
Figure 18-1 Utility > System submenu
This submenu is used to define system settings. An Administrator level password is required to display the Utility > System submenu.
u
For information about particular tasks associated with this submenu, see:
Programming system parameters (p. 507)
Assigning tests or profiles to test keys (p. 517)
Configuring automatic QC (p. 526)
Setting a yellow / purple alarm level (p. 528)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Programming system parameters
Many system parameter settings can be customized according to your laboratory’s needs. Your Roche technical representative programs these according to your specifications during installation.
You can adjust some system settings adequate to your access level.
Roche Diagnostics
Operator’s Manual · 4.2.1
507
18 Utility
System submenu
Roche Diagnostics
508 cobas® 8000 modular analyzer series q After (re)programming system parameters, it is strongly recommended that you make a backup disk. However, some items cannot be saved to disk.
u
See Saving system parameters (p. 532).
System parameter Menu/window
Assign Operator IDs
Assign Rack Numbers
Utility > System > Operator List
Utility > System > Rack Assignment
Set the Barcode Mode Utility > System > Barcode Settings
Define Check Digit Settings - Barcode Mode Utility > System > Barcode Settings
Define data manager communication settings
Utility > System > Data Manager Settings
Assign Test Keys
Define Test Group Names
Add/Edit a Profile
Utility > System > Key Settings
Utility > System > Key Settings
Utility > System > Key Settings > Profile
Setting
Set the Printer Page Size
Print Dilution Ratio
Define Comment Titles
Set Date and Time
Set the Screen Saver
Set the Order (Name/Test No.)
Define Rack Reception Mode
Variable Start Cell No.
Utility > System > Print Settings
Utility > System > Print Settings
Utility > System > Comment Titles
Utility > System > Display Settings
Utility > System > Display Settings
Utility > System > Display Settings
Utility > System > Rack Reception
Utility > System > Analyzer Settings
Wash Rack Sampling
Define Rack Delivery Setting
Define Sample Tube Rotation
Define sample container for backup operation
Define Rack Loading Limit
Maintenance Settings
Pipe Settings
Power Up Pipe Settings
Set Time to Unload
Define Alarm Settings
Define Result Upload Settings
Define QC Settings
Activate Calibration Mask Settings
Define Reagent Level Check Alarms
Check Special Reagents, Diluents and
Cleaners
Utility > System > Wash Racks
Utility > System > Rack Delivery
Utility > System > Rack Delivery
Utility > System > Rack Delivery
Utility > System > Rack Delivery
Utility > System > Maintenance Settings
Utility > System > Pipe Settings
Utility > System > Pipe Settings > Power Up
Pipe
Utility > System > Reagent Manager Settings
Utility > System > Alarm Settings
Utility > System > Result Upload Settings
Utility > System > Calib. and QC Settings
Utility > System > Calib. and QC Settings
Utility > System > Reagent Level
Utility > System > Utility Reagent Settings
Define ISE Calib Setting Utility > System > ISE Calib. Settings
Define Reagent Level Check Alarms ( c 702) Utility > System > Reagent Loading Level
Define a Start Up pipe
Activate Automatic Rerun
Start > Start Up Pipe Setting
Start > Automatic Rerun
Activate Time To Unload
Table 18-1 System parameters
Start > Time To Unload
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
System parameter
Define test and patient masking
Program Default Profiles
Set Alarm Sounds
Table 18-1 System parameters
Menu/window
Start > Masking
Start > Default Profile
Alarm > Sound
For more information about system settings, please refer to the Online Help of the
Utility menu or contact your Roche service representative.
Operator ID settings
$GPLQLVWUDWRU
6XSHUYLVRU
2SHUDWRU
Table 18-2 Access levels
Figure 18-2 Operator List window and Add window
Use these windows to add a new operator ID to the system (up to 16 characters). Up to 40 operator IDs can be assigned.
Use the Level list box in the Add window to select the access level for the new operator. Levels include Administrator , Supervisor and Operator (in descending order of access rights).
Access level
Administrator
Supervisor
Operator
Access rights
System configuration and maintenance settings
Basic system and application settings
Access to routine operation and maintenance functions without system settings
For information about the required access level for each window, please refer to the
Online Help.
Roche Diagnostics
Operator’s Manual · 4.2.1
509
18 Utility
System submenu
Rack Assignment
cobas® 8000 modular analyzer series
Figure 18-3 Rack Assignment window
Use the Rack Assignment window to assign rack ranges for routine, rerun and STAT samples for each sample type (Ser/Pl, Urine, CSF, …). The rack assignment must be done for standard tubes, non-standard tubes, and false bottom tubes.
The assignment is used to determine the sample type and the classification (routine, rerun, STAT) when the rack number is read after loading.
u
For information about applicable sample cups and tubes, see:
Container specifications (p. 213).
Sample types The rack ranges can be assigned for the following sample types: o
Serum/Pl: For serum or plasma.
o
Urine: For urine samples.
o
CSF: For cerebrospinal fluids.
o
Suprnt: For supernatants. Must also be used for whole blood ( c 502 only).
o
Others: Use this sample type for other body fluids than mentioned above.
o
None: Use this sample type to mix different sample types on one rack, for example, Serum/Pl and urine. On the Standard tab, you can also mix different container types.
u
For more information on the different rack classes, see:
Rack classes and colors of standard racks (p. 93).
Mixing sample types and container types on a rack
If you want to place different sample types on one rack, you must define a rack range for the sample type None and use a rack from the defined rack range. For each sample, you must select the sample type on the data manager, LIS, or control unit and assign a unique sample ID.
Sample consolidation can be useful, for example, if the instrument is connected with a CLAS. The CLAS can use the same rack range for pre-processing of different samples types. The information about the sample type is sent via HL7 protocol as segment SPM-4 to the control unit. If necessary, the information about the container type (segment SPM-27) is also sent via HL7 protocol.
Roche Diagnostics
510 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Note the difference between the Standard tab and the Non-Standard tab/ False
Bottom tabs regarding the mixing of samples on a rack: o
On the Standard tab, you use the sample type None to mix different sample types and container types on one rack. Any possible combination of containers is allowed within this rack range.
For standard tubes and standard cups: The height detection in the core unit can detect all types of standard sample containers, so you do not need to specify the container type on the data manager. You can specify the cup type ( Normal or
Micro cup ).
For non-standard or false bottom tubes: In addition to the sample type, you must specify the container type in the data manager ( False bottom tube 1-3 or Non-
Standard Tube 0 ).
o
On the Non-Standard tab and the False Bottom tabs of the control unit, you use the sample type None to mix different sample types on one rack.
You do not need to specify the container type on the data manager but you must use the container types according to the settings in the Rack Assignment window.
u
See: Which container for which application?
No Rotation Use this area to assign rack ranges for standard racks. When using standard racks, ensure that the center of the barcode label and the open slot are always in line. The system can only read the barcode if the label is correctly positioned. Otherwise, a barcode read error will be issued.
Rotation Use this area to assign rack ranges for MPA racks which allow tube rotation. When using these MPA racks the system rotate the sample tubes to read the barcode. This is only possible if Sample Tube Rotation is activated on Utility > System > Rack
Delivery .
u
For more information about the racks for tube rotation, see Rack types (p. 91).
Routine racks The number range (50 001 to 50 999, 60 000 to 60 999, 70 000 to 70 999, or 80 000 to
80 999) of gray routine racks can be divided into subranges for different sample types.
Rerun racks Using different racks for first run and rerun samples is only necessary in non-barcode mode for manual rerun. The rerun samples have to be put in rerun racks (pink).
In barcode mode, gray racks can also be used for rerun. If the instrument is in automatic rerun mode, the routine racks (gray) are also used to perform automatic rerun. The number range for rerun racks can also be divided into subranges for different sample types.
STAT racks The number range for STAT racks (40 001 to 40 999) (red) can also be divided into subranges for different sample types.
Roche Diagnostics
Operator’s Manual · 4.2.1
511
18 Utility
System submenu
Standard tab cobas® 8000 modular analyzer series
Figure 18-4 Rack Assignment window - Standard tab
Use the Standard tab to assign rack ranges for the use of standard containers.
The following containers are considered as standard containers: o
Standard sample tubes

13 or 16 mm, height 75 or 100 mm o
Hitachi standard cups (or the equivalent cobas sample cups) o
Hitachi micro cups o
Hitachi standard cups or micro cups on primary tubes with a height of 75 or
100 mm u
For details, see:
Container specifications (p. 213).
q Tubes with other dimensions must be defined on the Non-Standard tab.
Roche Diagnostics
512 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Non-Standard tab
18 Utility
System submenu
False Bottom tabs
Figure 18-5 Rack Assignment window - Non-Standard tab
Use the Non-Standard tab to assign rack ranges for the use of non-standard tubes.
u
For permissible dimensions of non-standard tubes, see:
Container specifications (p. 213).
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-6 Rack Assignment window - False Bottom tab
Use the False Bottom tabs to assign rack ranges for the use of false-bottom tubes
(FBT) or cup-on-non-standard tubes.
q There are some module-specific differences regarding the use of false bottom tubes.
u
See: False bottom tubes (FBT) (p. 214).
513
18 Utility
System submenu cobas® 8000 modular analyzer series
The specifications of false-bottom/cup-on-non-standard tubes must be defined on the False Bottom Settings window. To open this window choose the False Bottom
Settings button.
Figure 18-7 False Bottom Settings window
Use this window to define dimensions of false bottom tubes/cup on non-standard tubes. The following measurement must be defined: o Container height - length: 63 mm - 102 mm o
Bottom Level
u
For permissible dimensions of False Bottom tubes, see:
Container specifications (p. 213)
Which container for which application?
When using false bottom tubes/cup on non-standard tubes, the distance between the upper edge of the tube and the bottom level must be more than 20 mm.
A
C
B
A Container Height
B Rubber holder for the tube (inside the rack)
Figure 18-8 False bottom tube settings
C Bottom Level (15 mm for example)
If you use tubes with a conical bottom, select Conical bottom .
Roche Diagnostics
514 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Adjusting sample probe setting for false bottom tubes
When using false bottom tubes, standard cups or micro cups in combination with non-standard tubes (cup on tube), the system needs to know the bottom height of these sample containers in a rack. To let the system determine this bottom height, perform the procedure below.
Another condition for the use of false bottom tubes, standard cups or micro cups on non-standard tubes (cup on tube) is that you use only racks that belong to the correct rack range, according to the rack assignment. This, in turn, implies that a rack assignment for false bottom tubes must be programmed.
For the following procedure it is assumed that the necessary rack assignment is already programmed.
p To assign false bottom tubes
1
Choose Utility > System > Rack Assignment .
2
Choose a False Bottom tab
3
Choose False Bottom Settings button.
4
Enter the specifications of the relevant sample container.
s
Module Settings
For each module, specific calibrator and control racks can be defined. The specified racks are sent directly to the particular module. Calibrator and control measurements can be pipetted simultaneously on all modules.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-9 Rack Assignment window - Module Settings tab
At the bottom of this window, a rack range for auto QC racks can be defined.
QC racks within this auto QC rack range remain in the auto QC compartments of the module sample buffers.
o
They can be unloaded from the auto QC compartments using the Unloading window ( QC > Status > Unloading ). o
Only in case the Auto QC On-Board Stability Time is expired for all QC samples on the rack, an auto QC rack will be unloaded automatically.
515
18 Utility
System submenu cobas® 8000 modular analyzer series q In the default setting, only standard tubes and cups can be used for auto QCs. If you want to use false bottom tubes, please contact your Roche service representative.
u
See False bottom tubes (FBT) (p. 214)
u
For more information about auto QC, see:
To program automatic QC measurements for QC after calibration (p. 526)
To program automatic QC measurements for timeout QC (p. 558)
p To assign control racks for auto QC
1
Choose Utility > System > Rack Assignment .
2
In the Rack Assignment window, choose the Module Settings tab.
3
In the Auto QC text boxes, enter the rack range for control racks that are to be used for auto QC measurements
4
Choose OK .
s
Roche Diagnostics
516 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Assigning tests or profiles to test keys
To display the Key Settings window choose Utility > System > Key Settings .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-10 Key Settings window
The Key Settings window is used to assign tests or profiles to test keys which are used under Workplace > Test Selection . One test or profile can be assigned to each test key. Tests can be assigned for up to 6 groups of 32 keys per sample type. In total,
192 test keys are available for each sample type.
The most frequently used test combinations can be assigned to test profiles. Profiles allow selection of test combinations using only one test key.
p To define a group name q The group name can be defined individually, for example, hormones, thyroids, tumor marker.
1
Select a sample type from the Type list box. For example, Ser/Pl.
2
Select the Sheet tab (Sheet 1–6).
3
Type the name of the group in the Group Name box.
4
Choose Update to update the information.
s
517
18 Utility
System submenu cobas® 8000 modular analyzer series p To define a profile q Profiles are sample type specific, this means the sample type has to be selected.
1 Select a sample type from the Type list box. For example, Ser/Pl.
2 Choose Profile Setting on the Key Settings window. The Profile Setting window is displayed.
Roche Diagnostics
518 q
Figure 18-11 Profile Setting window
A maximum of 20 profiles can be defined in the Profile list.
3 Select an empty line in the Profile list.
4 Type the profile name in the Profile Name box.
5 Add the tests that should be included in the profile to the Assigned Tests list.
When adding the serum index tests, (L, H, I) to a profile, select the S.IND
test name. Do not add the SI or S-SI2 tests to a profile.
6 Choose Update to update the information and choose OK to save the profile settings.
If a profile is assigned to a key, the key is marked with a brown bar.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu p To assign a test or a profile to a key
1 Choose a key on the Key Setting window. The available tests and profiles are displayed.
q
Figure 18-12 Test Key Setting window
2 Select a test or a profile from the list and choose OK .
o If you want to delete a test key assignment, select None at the end of the list.
o Before you can select a profile, the profile must be defined.
3
Repeat steps 1 and 2 to select a key for other tests.
4
On the Key Settings window, choose Update to update the information.
5
Choose OK to save the changes and to close the window.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
519
18 Utility
System submenu
Rack Reception
cobas® 8000 modular analyzer series
Figure 18-13 Rack Reception window
Use this window to make the following settings: o Activate or cancel rack reception mode and set the time period. The following periods are available: 1, 2, 4, 8, 12, and 24 hours.
o
Activate or cancel photometric wash.
Rack Reception Mode Select the Rack Reception Mode check box to activate and configure the Rack
Reception Mode . When the rack reception mode is activated, you can choose this mode on the Start window.
For an analysis started without the rack reception mode (RRM), the instrument automatically enters the Standby mode after the last sample result is generated and the reaction cells used on the photometric modules are washed.
For an analysis started with the active RRM, the instrument remains in operation after the last sample result is generated and until one of the following actions occurs:
RRM is terminated regularly
RRM is cancelled
Table 18-3
Action / condition Result
Change button is chosen from Start window
Specified time has elapsed
A wash rack is loaded
Instrument goes into Standby
Instrument goes into Standby
The wash rack is processed, and then the instrument goes into Standby
(only if Green Rack during
Operation is not selected).
Instrument goes into Standby S.Stop
button is chosen
Stop button is chosen
A red alarm is issued
Instrument goes into Standby
Instrument goes into Standby
Stopping the instrument in Rack Reception Mode (RRM) q The remaining time for the RRM is shown in the status line.
Stop Washing (Photometric
Modules Only)
During operation and rack reception mode (RRM), the reaction cells are continuously washed. To disable the washing function during RRM, select the Stop
Washing check box. In this case, washing stops after the last sample is processed and all used reaction cells are washed. When the next analysis is started, cell washing automatically continues.
The Stop Washing check box must not be selected if auto QCs are to be measured during Rack Reception Mode (RRM).
This check box is available only if the Rack Reception Mode is selected.
Roche Diagnostics
520 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Analyzer Settings
18 Utility
System submenu
Figure 18-14 Analyzer Settings window
Use this window to specify the reaction cell that is used for the next analysis run and to choose the exchange rate and detergent type for the incubator bath.
Variable Start Cell No.
Select this check box to start the analysis run with the reaction cell next to the cell used last instead of starting from cell no.1.
Incubation Water Exchange
(High water exchange rate)
Select this check box for a high water exchange rate or clear it for a low water exchange rate.
To use the low water exchange rate, the following conditions must be fulfilled: o The water quality in respect of bacterial impureness must be good.
o
The incubator water must be exchanged daily (maintenance item (5) Incubation
Water Exchange).
o The incubator must be cleaned at least once a month (maintenance item
(10) Incubator Bath Cleaning).
The following table shows the detergent consumption and the time for exchanging the incubator water depending upon the setting of the exchange rate. Set the water exchange rate depending on the water quality in respect of bacterial impureness.
Select the low exchange rate only if the water quality is good.
High exchange rate
(1)
( long mode )
Low exchange rate
(2)
( short mode )
Consumption of
Ecotergent (approx.)
Runtime (approx.)
(3) c c
701 /
702 c 502 c 701 / c 702 c 502
15 mL
8 mL
17 min
19 min
12 mL
4 mL
9 min
5 min
Table 18-4 High exchange rate vs. low exchange rate
(1) Select the High Water Exchange Rate check box under Utility > System > Analyzer Settings .
(2) Clear the High Water Exchange Rate check box.
(3) Time for incubator water exchange.
Ecotergent Use this list box to select the detergent for the incubator bath. Ecotergent is the substitute for the previously used Hitergent.
Roche Diagnostics
Operator’s Manual · 4.2.1
521
18 Utility
System submenu
Rack Delivery
cobas® 8000 modular analyzer series
Figure 18-15 Rack Delivery window
STAT Rack Number Use this text box to set the number of slots that are reserved for STAT racks (0 to 17).
This number defines the total number of slots in all module sample buffers of the instrument.
Example: If the number is set to 2 in a configuration with three analytical modules, only two slots are reserved for STAT racks in total.
q Reserve at least one position for a STAT rack
If no position is reserved for a STAT rack and all positions are occupied by other racks, the
STAT rack cannot be processed until a rack is removed from the module sample buffer.
Sample Tube Rotation Select this check box to activate the sample tube rotation function. The sample rotation rack can be defined on Utility > System > Rack Assignment .
Backup Operation Sample Height Use the list box to select a sample container type for backup operation. It is necessary to set the used container type manually because the container type cannot be detected in backup operation mode.
NOTICE Property damage when using a wrong sample container
If a sample container is used in backup operation mode that does not match the set container height, the sample probe may crash into the container. This may damage the probe or the container.
r During backup operation, be sure to use only the type of sample container specified in the Rack Delivery window.
u
For information about Backup Operation, see
Loading Rack Limit Use this list box to limit the number of racks to be loaded onto the instrument at the same time. Unloading and exchanging racks requires free slots on the module sample buffers. The default setting is 100%.
Recommendation: Reduce the setting stepwise if you observe that racks with processed samples stay on the instrument over a long time and new racks are not loaded.
The default of 100% means that two of the 20 slots are reserved for rack exchange.
The priority for rack loading is higher than for unloading. If racks are not unloaded in time, two slots may not be sufficient for an optimized throughput.
Roche Diagnostics
522 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Loading Rack
Limit
100%
90%
80%
70%
60%
50%
Table 18-5
Max. number of loaded racks
1
Number of modules
2 3 4
Average number of slots
(per MSB) reserved for
Sample processing
Rack exchange
20
18
16
14
36
33
29
26
54
49
44
38
72
65
58
51
18
16.5
15
13
12
10
22
18
33
27
44
36
11
9
Available slots for rack exchange in dependence on the limit
5
7
2
3.5
9
11
When the number of racks on the instrument increases and the MSBs are full, rack exchange becomes more frequent. By limiting the number of racks, so that the MSBs do not become full, the number of rack exchanges for unloading racks decreases. This reduces the time that the racks reside in the MSBs after processing (turnaround time of racks to be unloaded).
The optimum setting depends on many factors (e.g., number of tests per sample, input frequency of racks on the loader, number of test requests for other modules, number of MSBs in the system, auto-rerun switched on or off). Therefore, there is no general recommendation for an optimized throughput.
Maintenance functions
The configuration of maintenance related items is described in the corresponding maintenance chapters. This refers to the following functions: o
Utility > System > Maintenance Settings (maintenance types) o
Utility > System > Pipe Settings (maintenance pipes and power up pipe function) o
Utility > Maintenance (execution of maintenance items and maintenance checks) u
For information, see:
Defining and editing maintenance types (p. 606)
Defining and editing maintenance pipes (p. 596)
Power Up Pipe function (p. 599)
Roche Diagnostics
Operator’s Manual · 4.2.1
523
18 Utility
System submenu
Reagent Manager Settings (cobas c 702 module)
cobas® 8000 modular analyzer series
Figure 18-16 Reagent Manager Settings window
Use this window to define the settings for automatic unloading of reagent packs from the reagent disks. The number of slots on the reagent disks that are used for privileged reagent packs is also set here.
u
For more information, see Unloading reagents from the unloading tray (p. 371).
Time to Unload Mode Select this check box to activate and configure the Time to Unload Mode . If this mode is activated, reagent packs that are reserved for unloading can be unloaded automatically via the unloading tray. Unloading starts after the set time of day only when the module is not busy (e.g., in Rack Reception Mode). If this mode is not active, the entire instrument must be in Rack Reception Mode for automatic unloading.
When the Time to Unload Mode is activated, you can adapt its settings on the Start window.
Set Time Use these text boxes to set the time of day for automatic unloading (hh:mm). These text boxes are available only if the Time to Unload Mode check box is selected.
Vacant Slot Use this text box to set the number of slots per reagent disk that is always reserved for privileged reagent packs. Privileged are those reagent packs that are able to trigger a loading process. Examples: The reagent volume is below the loading limit or the
Reagent Manager On-Board Stability Time ≤ 0.
In addition to the set number for privileged reagent packs, one position is always reserved for the normal reagent pack transfer.
u
See Loading triggers (p. 361).
Roche Diagnostics
524 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Calib. and QC Settings
18 Utility
System submenu
Figure 18-17 Calib. and QC Settings window
This window is used to activate calibration masking and to define QC settings.
Calibration Settings (Auto. Masking)
If the calibration of a test fails and Auto. Masking is selected, the test will be masked automatically.
On the Calibration > Status submenu, a failed calibration is indicated by a red bar for the particular reagent pack. The corresponding calibration mask is indicated by a purple bar on the Workplace > Test Selection submenu.
q The purple bar on the Workplace > Test Selection submenu is only displayed if the test cannot be performed on the instrument because all reagent packs of this test are masked due to no valid calibration. This means, if there is still one successfully calibrated reagent pack, the purple bar is not displayed on that particular test key.
After a successful calibration, the reagent pack is unmasked. p To activate the Auto. Masking function
1 Select the Auto. Masking check box in the Calib. and QC Settings window.
2 On Utility > Application > Calib.
select the Auto. Masking check box individually for each application.
u
See
To define application auto masking (p. 555).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
525
18 Utility
System submenu cobas® 8000 modular analyzer series
Configuring automatic QC
When the Routine QC Test Selection check box is selected, the Routine QC test selections are used when no other test selections are made on QC > Status at the moment the instrument recognizes the QC rack. In this case, QC measurements are requested automatically.
If the Auto. QC with QC After Calibration function is selected and if there is an auto QC rack in the auto QC compartment with a suitable control, the system performs automatic QC measurements after calibration without any intervention by the operator.
If the Auto. QC Request to Loading R. Pack function is selected and if there is an auto QC rack in the auto QC compartment with a suitable control, the system performs QC measurements without any intervention by the operator when a new reagent pack is loaded ( c 702 only).
p To program automatic QC request for Routine QC
1
Choose Utility > System > Calib. and QC Settings .
2
Select the Routine QC Test Selection check box.
3
Choose OK .
s p To program automatic QC measurements for QC after calibration
1 Choose Utility > System > Calib. and QC Settings .
2 Select the Auto. QC with QC-After-Calib check box.
3 Choose OK .
4 Assign control racks for auto QC.
u
See
To assign control racks for auto QC (p. 516).
s p To program automatic QC requests when new reagents are loaded (c 702 only)
1 Choose Utility > System > Calib. and QC Settings .
2 Select the Auto. QC Request to Loading R. Pack check box.
3 Choose OK .
4 Assign control racks for auto QC.
u
See
To assign control racks for auto QC (p. 516).
s
Roche Diagnostics
526 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Reagent Level
18 Utility
System submenu
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-18 Reagent Level window (all modules)
Use the Reagent Level window to define the level of reagent for each module at which a yellow or purple reagent level alarm is issued.
The system uses the following alarm levels to inform about the reagent level:
Purple
Yellow
Red
The purple alarm is used to set the amount of reagent for one day.
The yellow alarm should be used to define a caution level for each reagent. When the yellow alarm is issued, the required reagents should be provided.
The red alarm indicates that the corresponding reagent is empty.
The reagent level alarm is issued on the following menus, if the number of remaining tests / remaining volume is less than defined: o
On the Overview menu the following buttons change their color to yellow or purple: Reagent Preparing button and Reagent Overview buttons.
o
On the Reagent > Setting and Reagent > Status submenu, the tests are marked in the corresponding color.
q Select the Preventive Action check box on the Overview menu to activate the purple alarm. The purple alarm is issued only if this check box is selected.
527
18 Utility
System submenu cobas® 8000 modular analyzer series
Setting a yellow / purple alarm level
For test reagents both alarm levels are set by the number of tests remaining; for wash solutions and diluents by the volume (mL) remaining.
For immunoassays that require a pretreatment, the alarm levels are set by the number of Available Tests of the test. The lower number of remaining tests in one of the linked reagent packs determines the number of available tests. p To define a yellow / purple alarm level
1
Choose Utility > System > Reagent Level .
2
Select a test, wash solution, or diluent whose alarm level is to be viewed or edited from the Test list.
3
In the corresponding Alarm area, select the Activate Alarm check box to activate the reagent level alarm for the test, wash solution, or diluent currently selected in the test list:
For a yellow alarm in the Yellow Alarm area and for a purple alarm in the Purple
Alarm area.
4
In the corresponding text box, type the reagent level at which the yellow / purple alarm is to be issued.
For test reagents, the level is defined as number of tests remaining. For diluents and wash solutions, the level is defined in milliliters (mL).
5
Choose Update to update the new information
6
Choose OK to save the changes and to close the window.
s
Yellow / Purple alarm settings overview
Module name
Type/Test Comment Input ranges for yellow and purple alarm
0–9999 mL ISE c c c
701 /
701 /
701 / c c c
702
702
702 c 502
Table 18-6
Reagent (ISE IS, ISE DIL,
ISE REF (KCl)
Reagent pack
Special reagent
Diluent (DIL) c 701 / c 702 Wash solution for reagent probes
(Washer D1–D2) c 701 / c 702 Wash solution for sample probe
(SmpCln 1, SmpCln 2) c 701 / c 702 Additive for incubator bath
(Ecotergent) c 701 / c 702 Wash solution for cuvettes
(CellCln 1, CellCln 2)
An alarm can be activated if ISE is detected.
Number of determinations in a reagent pack.
Volume warning level for special reagents (SPR)
Volume warning level for diluent (NaCl reagent pack).
If diluent is not on board or empty, tests that are using diluent are not masked. It is strongly recommended to assign an alarm level.
Volume warning level for the wash solution in reagent packs (NAOHD, SMS)
Volume warning level for the wash solution in the container
Volume warning level for the incubator bath detergent in reagent pack; only purple alarm possible.
Volume warning level for the wash solution in reagent container (NAOHD, Acid Wash)
Reagent pack Number of determinations in a reagent pack.
Yellow / Purple alarm settings overview
0–9999 tests
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 tests
Roche Diagnostics
528 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Module name c 502 c 502 c 502 c 502 c 502 e 602 e 602 e 602
Table 18-6
Type/Test Comment Input ranges for yellow and purple alarm
0–9999 mL Diluent (DIL)
Wash solution for reagent probes
(Washer D1–D3)
Wash solution for sample probe
(SmpCln 1, SmpCln 2)
Additive for incubator bath
(Ecotergent)
Wash solution for cuvettes
(CellCln 1, CellCln 2) cobas e pack
Volume warning level for diluent (NaCl reagent pack).
If diluent is not on board or empty, tests that are using diluent are not masked. It is strongly recommended to assign an alarm level.
Volume warning level for the wash solution in reagent packs (NAOHD, SMS, SCCS)
Volume warning level for the wash solution in the container
Volume warning level for the incubator bath detergent; only purple alarm possible.
Volume warning level for the wash solution in reagent container (NAOHD, Acid Wash)
Number of determination in a cobas e pack
Diluent (DIL)
Pretreatment (PRE)
Volume warning level for diluent
Number of Available Tests for the linked pair of assay and pretreatment reagent packs
Yellow / Purple alarm settings overview
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 mL
0–9999 tests
0–9999 mL
0–9999 tests
Roche Diagnostics
Operator’s Manual · 4.2.1
529
18 Utility
System submenu
Reagent Loading Level (cobas c 702 module)
cobas® 8000 modular analyzer series
Figure 18-19 Reagent Loading Level window ( c 702 only)
Use the Reagent Loading Level window to define the Yellow Loading Limit and the
Initial Loading Limit for tests on each reagent disk.
q Loading limit
The loading limit for reagent packs on the c 702 module is fixed to 15 tests. This limit is not shown in the user interface.
If the remaining number of tests falls below this limit, a loading trigger is issued and the loading process starts even if the instrument is in operation. The required reagent packs must be available in the buffer rotor, of course.
u
See Loading triggers (p. 361).
Yellow Loading Limit The Yellow Loading Limit is a threshold that triggers the instrument to load the corresponding reagent pack during Standby or Rack Reception Mode (RRM).
If the remaining number of tests falls below the Yellow Loading Limit , a yellow alarm is issued. During Standby or RRM, a reagent pack waiting on the reagent manager with such a yellow alarm is loaded directly. During operation, the waiting reagent pack is added to the loading queue and will be loaded in the next loading session triggered by another reagent pack.
u
For information on loading triggers during operation, see
Initial Loading Limit If a reagent level falls below this initial limit, this reagent will be listed on the Reagent
Load/Unload List .
The Initial Loading Limit does not influence loading. The ratio of the remaining number of tests to this limit is only printed out on the Reagent Load/Unload List .
Example: If the initial loading limit is set to 2100 tests and 2044 tests are remaining on this reagent disk at the time of printing the report, the ratio is 97%. The number of required cobas c packs is listed.
Roche Diagnostics
530 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System submenu
Setting a yellow / initial loading limit (cobas c 702 module)
Both the yellow loading limit and the initial loading limit are set for individual tests by number of tests remaining; for wash solutions and diluents by mL remaining.
p To define a yellow / initial loading limit
1
Choose Utility > System > Reagent Loading Level .
2
Select a test, wash solution, or diluent whose loading limit is to be viewed or edited from the Test list.
3
Type the Yellow Loading Limit and the Initial Loading Limit in the corresponding text boxes ( Disk A or Disk B ).
Note that the Initial Loading Limit must be set to a larger value than the Yellow
Loading Limit .
4
Choose Update to update the new information
5
Choose OK to save the changes and to close the window.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
531
18 Utility
Maintenance submenu
Maintenance submenu
cobas® 8000 modular analyzer series
This chapter describes how to make a backup of system parameters and how to restore system parameters from a backup.
u
For more information, see:
Saving system parameters (p. 532)
Restoring system parameters (p. 534).
The configuration of maintenance related items is described in the corresponding maintenance chapters.
u
For information, see part Maintenance (p. 577).
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Saving system parameters
Use the following procedure to make a backup of system parameters on a storage medium (DVD).
q Restoring the system parameters
The system parameters can only be restored to the same cobas® 8000 instrument. Use the Parameter Read option in the Parameter Read/Write window.
u
See Restoring system parameters (p. 534).
p To save system parameters on a storage medium
1 Wait until the system is in Standby.
2 Insert a storage medium into the appropriate disk drive.
3 Choose Utility > Maintenance .
Roche Diagnostics
532
Figure 18-20 Utility > Maintenance submenu
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
4 Select Maintenance from the Maintenance Type list.
5 Select (14) Parameter Read/Write .
6 Choose Select to display the Parameter Read/Write window.
18 Utility
Maintenance submenu
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-21 Parameter Read/Write window
7 Select the Parameter Write option and choose Execute to save parameters to the storage medium after confirmation.
The following system information is written:
System parameter System parameter
Application settings
Special wash settings
System settings
Data manager communication settings
Maintenance pipe settings
Profile settings
Utility reagent settings
Start settings
Calculated and compensated test settings
Alarm settings
Comment Settings
Operator ID setting parameters
Barcode check digit settings
Power up pipe settings
Scale settings for each graph
Data manager settings
Key settings
Channel assignment parameters
Table 18-7
CLAS settings
Module settings
System parameters stored using the Parameter Write option
8 When processing is complete, remove the storage medium from the control unit computer.
s
533
18 Utility
Maintenance submenu
Restoring system parameters
cobas® 8000 modular analyzer series
Use the following procedure to restore system parameters from a storage medium.
The system parameters can only be restored to the same cobas® 8000 instrument.
p To restore system parameters to the system
1
Choose Utility > Maintenance .
2
Select Maintenance from the left list.
3
Select (14) Parameter Read/Write from the right list.
4
Choose Select to open the Parameter Read/Write window.
5
Insert the storage medium into the disk drive.
6
Select the Parameter Read option.
7
Choose Execute and confirm with Yes to start loading the data.
s
Roche Diagnostics
534 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Application submenu
When the system was installed by your Roche service representatives, all required applications were installed. This section explains how to add new applications and configure specific application parameters.
Introduction
General information for chemistry tests
Up to 200 photometric applications can be registered (test numbers 1–200). The following test numbers are fixed:
Test number
1
2
3
1
2
3
1–8
Table 18-8 Fixed test numbers
Test name
Na
K
Cl
Serum index L
Serum index H
Serum index I
Calculated tests
General information for immunoassays
Up to 100 heterogeneous immunoassays can be installed, irrespective of the number of modules. Applications can be assigned individually to each module and measuring channel (e1-1, e1-2 and e2-1, e2-2) using Utility > System Configuration > Test
Assignment .
Development channel applications A development channel application must be installed via the data manager. All application fields are accessible and parameters can be entered manually.
CAUTION
Incorrect results when using development channel applications r When using a non-Roche reagent, follow the instruction of the non-Roche reagent supplier. For change of assay parameters, consult with the non-Roche reagent supplier. Roche is not responsible for parameters that are not correct. q The installation of Development Channel applications is described in the Instructions for
Use of the cobas c pack MULTI. Please contact your Roche representative for more information.
Loading a new application Before you can load a reagent pack of a new application onto the instrument, the application parameters must be downloaded from the data manager. Otherwise, the reagent pack will not be recognized correctly by the system. u
Refer to the following procedure to get information about
To configure the application data (p. 536).
Roche Diagnostics
Operator’s Manual · 4.2.1
535
18 Utility
Application submenu
Installing applications (overview)
cobas® 8000 modular analyzer series
The instrument requires application parameters, calibrator data, and control data for each application. All necessary data can be downloaded from the data manager. After download, various settings and customizing of default parameters are required to complete the installation.
For most of the installation procedures, an administrator access is required to access all installation options. A supervisor access allows only the newest release of an application to be downloaded.
Installation procedures To install a new application, you have to perform the following procedures: o
To configure the application data (p. 536)
o
To configure the calibrator data (p. 537)
o
To configure the control data (p. 537)
o
To configure additional settings (p. 537)
o
To finalize the installation (p. 538)
p To configure the application data
1
Download the application parameters from the data manager.
u
See
Downloading application parameters (p. 538).
2
(Optional) Customize application parameters, for example: o
Automatic calibration timeouts, automatic masking, etc. on Utility
> Application > Calib.
o
Automatic rerun, number of Decimal Places , etc. on Utility > Application
> Range u
See
Description of application parameters (p. 551).
3
Assign the application to a module.
u
See:
Assigning a test to a module (p. 574)
4
Assign the application to a test key or profile.
u
See:
Assigning tests or profiles to test keys (p. 517)
5
(Optional, but recommended) Define the reagent warning levels.
u
See:
Setting a yellow / purple alarm level (p. 528)
Setting a yellow / initial loading limit (cobas c 702 module) (p. 531)
6
Download parameters for diluent and wash solution.
o
Only possible for photometric applications.
o
Only required for not yet registered diluents or wash solutions.
u
See
Downloading parameters for diluents and wash solutions (photometric modules)
7
Define an application-specific instrument factor as recommended in the
Instructions for Use.
o
Only necessary for certain photometric applications, e.g., for Creatinine Jaffé.
o
Only required for diluents or wash solutions not yet registered.
u
See
s
Roche Diagnostics
536 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu p To configure the calibrator data
1 Download the calibrator data.
u
See
Installing calibrators (p. 429).
2 Assign the rack position for the calibrator.
o
Only necessary if you are working with non-barcoded calibrators.
u
See
Assigning calibrator positions (p. 426).
s p To configure the control data
1
Download the control data.
u
See
2
Assign the rack position for the control.
o
Only necessary if you are working with non-barcoded controls.
u
See
Assigning control positions (p. 469).
3 (Optional) Configure an automatic QC measurement for the control.
u
See
Automatic QC request (p. 454).
4 (Optional) Configure non-Roche controls using the data manager component
Control material . Download the control data from the data manager.
5 (Optional) Assign a Westgard rule using the data manager component Westgard rule assignment . u
For more information on the data manager components, please refer to the corresponding section in the Operator’s Manual or the Online Help of the cobas 8000 data manager.
s p To configure additional settings
1 (Optional) Program a special wash or install a special wash via download.
u
See:
Programming a special wash (photometric modules) (p. 565)
Programming a special wash (cobas e 602 module) (p. 570)
Installing special wash parameters (p. 572)
2 (Optional) Program a formula using the two data manager components
Formulas and Tests / reference ranges .
3 (Optional) Using the data manager component Instrument , you may perform the following settings: o
Deactivate the Automatic patient masking when QC error setting.
o
Activate or deactivate the Relevant for validation setting.
4
(Optional) Using the data manager component Tests / reference ranges , you may perform the following settings: o
Program a validation range.
o
Program actions (e.g., reflex).
o
Activate or deactivate the Ignore technical validation and Release repetitions settings.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
537
18 Utility
Application submenu cobas® 8000 modular analyzer series p To finalize the installation
1 Load the reagent pack(s) into the modules.
2 Calibrate the application.
u
See
Requesting and cancelling calibrations manually (p. 423).
3 Perform QC measurements.
u
See
Requesting QC measurements manually (p. 463).
4 Make a backup of the system parameters after finishing the installation of all new applications.
u
See
Saving system parameters (p. 532).
s
Downloading application parameters
The following procedure describes the download of application parameters from the data manager.
u
For updating already installed applications, see:
Updating applications (p. 541)
Supervisors may download parameters for the newest and current release of an already installed application. Administrators may select the release of an application to be downloaded and may install new applications.
Update application to newest release
Download currently installed release again
Supervisor l l
Download any application and release
Table 18-9
–
User rights for downloading application parameters
Administrator l l l q Up to four applications per cobas c pack
Up to four applications per cobas c pack can be installed on an instrument, for example,
Ca 8706 (10 min) and 8726 (STAT 3 min). Install all required applications of a reagent before you load the cobas c pack onto the system.
Roche Diagnostics
538 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu p To download application parameters
1 Choose Utility > Application > Download to open the Download window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-22 Download window
2 Select the application to be installed. You may use one of the search options: o
All Item s: Select the application directly from a list of all applications. o Application Code : This search option is recommended if you know the ACN.
The application code number (ACN) is available in the Instructions for Use of the corresponding reagent pack. Up to four applications (ACN) per reagent pack are possible. o Application Name : Select the application name from the list box.
o
R. Pack ID : Enter the reagent pack number in the text box.
q R. Pack ID and System-ID
Different terms are used for the reagent pack number: o R. pack ID in the instrument software o System-ID on cobas c packs o
Required Item : This search option lists all applications for which the reagents are on board but the application information was not yet downloaded.
3 Choose Search to start searching for the selected criteria. The search results are displayed in the Result area.
4 Select the check box of the application to be downloaded.
539
18 Utility
Application submenu cobas® 8000 modular analyzer series
5 Choose Download to display the Confirmation window.
Roche Diagnostics
540 q
Figure 18-23 Confirmation window for new (left) and for updated (right) applications
6 Check and complete the settings displayed in the Confirmation window: o
The Test No.
may be changed now if needed.
o
The Application Name may also be changed if needed.
o
If another Unit should be used for the test, the unit must be changed here.
o
The Current Release Date refers to the reagent lot currently on board. This is only available if the same reagent lot is requested for download.
o
The Addition Release Date shows the release that will be newly installed.
Administrators may select other available releases (the newest one is always on top).
o
The Update Release Date is similar to the Addition Release Date , but will only be displayed if an existing application is updated.
Once the application has been downloaded, the Application Name and the Unit cannot be changed. In order to change the name or the unit, the application must be deleted and downloaded again.
q
7
If you are installing a new application, choose OK to confirm the settings and to download the application.
The window is grayed out for a moment until the download is finished.
8
If you are updating an application, select one of the buttons: o
Choose Overwrite to overwrite all parameters with the new settings.
o
Choose Partial Overwrite to overwrite only parameters that are not editable.
All user-editable parameters keep their current settings. This saves time for reentering parameter settings.
Please check the Application Sheet or Customer Information letters whether
Overwrite or Partial Overwrite are recommended for this release.
9 Calibrate the reagent pack for the application if the software indicates this.
If a reagent pack has been on the instrument before the download, the software deletes all related calibration results and issues a calibration recommendation.
The reagent pack stays masked (calib mask) until you calibrate it.
10 Choose Close to return to the Utility > Application screen.
The application parameters of the downloaded application are displayed on the
Application screen.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
11 Check the following settings on Utility > Application > Other : o
Are volumes defined for each calibrator?
o
Is Assigned displayed for each non-barcoded calibrator?
If one of these parameters is missing for a photometric application, a red alarm
( Calibration Parameter Error ) will occur.
12
Continue with the next installation step: Depending on your requirements, you may customize application parameters.
u
See
Description of application parameters (p. 551).
s
Updating applications
When an application that was already installed has been updated by Roche
Diagnostics, an update of the application is required. If this occurs, you will be informed by the yellow Parameter Download button.
q Manually edited application parameters
Until software version 05-01, user-editable parameters were not updated when you downloaded an updated application from the data manager. User-editable parameters were not overwritten with new settings even if you did not modify any setting.
Since software version 05-01, you can select between Overwrite and Partial Overwrite .
o To download the application with all new settings, choose Overwrite . You do not need to delete the application beforehand.
o To keep the settings of all user-editable parameters, choose Partial Overwrite .
o Check the application parameters after download.
o Calibrate the test if this is indicated by the software.
Editable parameters The following parameters under Utility > Application can be edited by users and are not overwritten by Partial Overwrite . To update the editable parameters with the new settings provided by Roche, choose the Overwrite button.
Parameter group
Calib.
Table 18-10
Editable parameter
Application short name ( Test column)
Auto. Calibration area: o
Changeover of lot (chemistry) o
Changeover of reagent pack o
Timeout of lot o
Timeout of reagent pack
Auto. Masking check box
SD Limit (chemistry)
Duplicate Limit
Sensitivity Limit (chemistry)
S1 Abs. Limit (chemistry)
List of user-editable parameters
Roche Diagnostics
Operator’s Manual · 4.2.1
541
18 Utility
Application submenu
Roche Diagnostics
542 cobas® 8000 modular analyzer series
Parameter group Editable parameter
Range Control Interval check box and time setting
Technical Limit (chemistry)
Repeat Limit
Qualitative check box and settings (chemistry)
Test Priority (immune)
Serum Index Check Value for L, H, I (immune)
Other (chemistry)
Table 18-10
Sample Volume for Std(1)
Diluted S. Volume for Std(1)
Diluent Volume for Std(1)
List of user-editable parameters
When an application is updated by Roche Diagnostics, the application code number
(ACN) and the application name remain unchanged. Therefore, an installed application will be overwritten when installing a newer version.
The following table shows which data are changed by updates and how the newest version of an application can be identified:
Data Changed by updates Indication of newest version
Application code number
(ACN)
Application name
Version
(1)
Not changed
Not changed
Changed Highest version number
Release date
(1)
Table 18-11
Changed
Updates of applications
Latest release date
(1) Displayed in the Confirmation window after the application was selected for download.
p To update applications
1 If you edited any parameter settings manually, note your customized settings.
This is not necessary if you want to keep all user-editable settings ( Partial
Overwrite ).
2 For c 702 modules: Unload the reagent packs for the corresponding application.
For c 502 modules: Unload and discard used and standby reagent packs.
3 Download the new application.
u
See
To download application parameters (p. 539).
4 If you used manually edited parameter settings, re-enter the settings.
5 Load the reagent packs for the corresponding application.For c 701 and c 702 modules: Perform a reagent registration.
6 Calibrate the newly loaded reagent packs.
For e 602 tests, the software does not request calibration. However, we recommend to calibrate the tests.
7 Check all application settings and the assigned calibrator data and control data.
If updating of calibration data or control data is necessary, you will be informed by the data manager.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Downloading parameters for diluents and wash solutions (photometric modules)
Parameters for diluents and wash solutions for photometric applications must be downloaded once from the data manager.
q Only diluents and wash solutions supplied in cobas c packs
Only parameters for diluents and wash solutions that are supplied in cobas c packs must be downloaded from the data manager.
Parameters for diluents supplied in cobas e packs cannot be downloaded.
Downloadable diluents and wash solutions
The following table shows the diluents and wash solution that can be downloaded.
Type Short name ACN
Detergent 1
Detergent 2
Detergent 3
Diluent
Diluent
Table 18-12
NAOHD
SMS
SCCS
947
948
949
NaCl
A1CD2
951
952
Diluents and wash solutions for photometric applications p To download parameters for diluents and wash solutions
1 Download the parameters.
u
See
To download application parameters (p. 539).
You may use the application code number (ACN) listed in Table
to find the downloadable parameters.
2 Choose Utility > System > Utility Reagent Settings and check information of registered diluents and wash solutions.
u
For information about special washes, see
Programming a special wash (photometric modules) (p. 565).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
543
18 Utility
Application submenu cobas® 8000 modular analyzer series
Installing the Hemoglobin A1c whole blood application (c 502)
This section describes the necessary steps to use the HbA1c whole blood application
(only available on c 502 modules).
u
For general information on installing applications onto the instrument, see
Installing applications (overview) (p. 536).
Overview
Necessary applications The second or third generation (gen. 2 or 3) of the HbA1c application can be used on the instrument.
To obtain results for HbA1c (%), the following applications are necessary:
Application/Reagent Short name gen. 2
Short name gen. 3
Hemoglobin
Hemoglobin A1c
Hb-W2
A1-W2
Hb-W3
A1-W3
% ratio of hemoglobin A1c/hemoglobin RWI2
Hemolyzing reagent A1CD2
Table 18-13
RWD3
A1CD2
Applications and reagents for the HbA1c (%) application
Generic name for gen. 2/3
Hb-Wx
A1-Wx
RWx q Generic names of the applications
The generic names with the x are used in the following sections to avoid repetitions. Both generations (2 and 3) of the applications can be used. Table
names for each generation.
Reaction course The following figure shows the reaction course of the application:
$ % & '
Roche Diagnostics
544
&
65
'
5
&\FOHWLPH
Figure 18-24
A
B
Reaction course of the HbA1c application
Sample pipetting: For pipetting EDTA whole blood sample, the sample probe is lowered down to 70 % of the filling volume.
Hemolyzing process: EDTA whole blood sample is pipetted into the predilution cuvette and is hemolyzed with hemolyzing reagent (A1CD2).
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
C
D
Hemoglobin analysis: Hemolyzed (prediluted) sample (S) and R1 (Hb-Wx reagent) are pipetted into the reaction cuvette (1-point assay, cycles 1–34).
Hemoglobin A1c analysis: R3 (A1-Wx reagent) is added (2-point assay, cycles 34–70).
Result calculation The result for the Hemoglobin A1c analysis is calculated according to IFCC standardization and can either be selected as IFCC values or DCCT/NGSP values.
This calculated test can be downloaded as application RWx.
u
Please refer to the Instructions for Use for the calculation formulas.
Installing and configuring the HbA1c application
To use the HbA1c application on the system and to obtain results according to IFCC reporting range, you must perform the following installation procedure.
u
For more details of each step, please refer to the general installation procedure
Installing applications (overview) (p. 536).
p To install the HbA1c application
1 Download the application parameters for the following applications: o
Hemoglobin (Hb-Wx) o
Hemoglobin A1c (A1-Wx) o
% ratio of hemoglobin A1c/hemoglobin (RWx) o
Hemolyzing reagent (A1CD2) u
See
Downloading application parameters (p. 538).
q Do not use the automatic rerun
Clear the Automatic Rerun check box for the whole blood application on Utility
> Application > Range .
2
Download the required calibrator recommended in the Instructions for Use.
3
This step is only necessary for the generation 2 application:
To improve the fit of the nonlinear HbA1c calibration curve, a constant and lotindependent offset of 0.6 g/dl was added to all calibrator values. This offset is already included in the assigned HbA1c calibrator target values and finally needs to be subtracted from the HbA1c results.
Please ensure that b = -0.6 is assigned to A1-W2 in Calibration > Status
> Instrument Factor .
4
Download the control data according to the Instructions for Use.
5
Set the decimal places of the calculated test RWx on Utility > Application
> Range .
Roche recommends reporting the results to one decimal place.
u
See
To define the number of decimal places (photometric and ISE tests) (p. 557).
6
To report results according to IFCC standardization, program a calculated test on the data manager (under Test configuration > Component > Test reference range ).
To report results according to DCCT/NGSP standardization, a calculated test under Utility > Application > Formula is required.
u
See
Notes for the use of the application (p. 547).
Roche Diagnostics
Operator’s Manual · 4.2.1
545
18 Utility
Application submenu cobas® 8000 modular analyzer series
7 Assign the RWx test to a module.
8 Assign the RWx test to a key on the Suprnt tab (supernatant) of the Key Settings window.
9 Assign a rack range for Suprnt depending on the used sample tubes.
u
See:
Sample type and rack assignment (p. 547)
Sample tubes for the HbA1c application (p. 547)
10 Load the reagent packs for the following applications: o
A1C-x: Hemoglobin (Hb-Wx)/Hemoglobin A1c (A1-Wx) o
A1CD2: Hemolyzing reagent
11
Program special washes for the sample probe and / or the reaction cells as stated in the Carry over evasion list . This list is available on cobas link.
A
B
C
D
A Special wash before sampling
B Special wash after sampling of whole blood
Figure 18-25
C Special wash for the reaction cuvette that contained the hemolyzed sample and HbA1c reagent
D Special wash for the predilution cuvette that contained hemolyzed whole blood
Examples for special washes for the HbA1c application u
For detailed information on how special washes are programmed, see
Programming a special wash (photometric modules) (p. 565).
12 Calibrate the following tests and perform QC measurements: o Hb-Wx o
A1-Wx u
See:
Requesting and cancelling calibrations manually (p. 423)
Requesting QC measurements manually (p. 463)
s
Roche Diagnostics
546 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Notes for the use of the application
Roche provides the application RWx to calculate the hemoglobin A1c% results according to IFCC standardization.
Result calculation according to
IFCC standardization
To report the results in mmol/mol, you must add a new test for the sample type
Suprnt (supernatant) in the data manager. Enter the following equation using the data manager component Tests / reference ranges :
Equation 18-1
RWIx =
A1-Wx
HB-Wx
 1000
This equation applies to generation 2 and 3.
Result calculation according to
DCCT/NGSP standardization
To report the results according to DCCT/NGSP standardization, make sure that the following calculated test is displayed under Utility > Application > Formula :
For generation 2, this equation must be entered manually:
Equation 18-2
RWI 2 =
A1-W2
HB-W2
 87.6 % + 2.27
For generation 3, the equation is displayed automatically:
Equation 18-3
RWD 3 =
A1-W3
HB-W3
 91.5 % + 2.15
For results according to DCCT/NGSP, no setting on the data manager is required.
Sample type and rack assignment The Suprnt (supernatant) sample type is used for the HbA1c whole blood application.
The rack range must be defined under Utility > System > Rack Assignment using the Suprnt text boxes. Depending on the sample tubes used, the rack range must be defined on the Standard or on the Non-Standard tab (see Table
Sample tubes for the HbA1c application
For running the HbA1c whole blood application, only tubes with the following specifications can be used:
Container Rack assignment Diameter × length Dead volume
Standard tube
(Standard sample tube)
Standard
Standard
Standard
Standard
Non-Standard
13 mm × 75 mm 500 μ L
13 mm × 100 mm 500 μ L
16 mm × 75 mm 1000 μ L
16 mm × 100 mm 1000 μ L
11 mm × 66 mm 1000 μ L
Sarstedt Monovette 2.7 mL
(1)
BD vacutainer 3.0 mL
Sarstedt tube 5.0 mL
Standard
Standard
12 mm × 75 mm
13 mm × 75 mm
600 μ L
650 μ L
Sarstedt tube 13.0 mL
Table 18-14
Standard 16 mm × 100 mm
Sample tubes for the HbA1c application
1000 μ L
(1) See
Sarstedt Monovette tubes (p. 548).
For HbA1c whole blood QC measurements, sample cups placed directly on a control rack can be used.
Roche Diagnostics
Operator’s Manual · 4.2.1
547
18 Utility
Application submenu cobas® 8000 modular analyzer series q o We recommend mixing whole blood samples manually before loading to ensure accurate pipetting.
o For the use of blood collection systems as sample tubes, please contact your Roche representative.
Sarstedt Monovette tubes For the Sarstedt Monovette 2.7 ml tubes, the rack range must be defined for nonstandard tubes on Utility > System > Rack Assignment > Non-Standard . In addition, the racks must be prepared for the Sarstedt Monovette 2.7 ml tubes. The black rubber plug must be removed from the rack and tube adapters must be inserted with the RD5 Insert Tool.
Clot detection Clot detection is automatically deactivated when pipetting whole blood samples.
Roche Diagnostics
548 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Installing the serum index application (photometric modules)
The serum indices are used to indicate any interference in the sample caused by bilirubin, hemoglobin, or lipemia (turbidity). Each photometric application has specific interference limits that are set as Serum Index Check Values L , H , and I on
Application > Range .
Serum index values
L Lipemia index Turbidity
H Hemolysis index
I Icterus index
Table 18-15 Serum index values
Hemoglobin
Total bilirubin
If a serum index value is outside the application-specific limit, a data alarm is issued to indicate a problem with the sample material.
u
For details on serum index test principles, please refer to the COBI CD.
This section describes the necessary steps to install the serum index application on a photometric module.
q STAT application
It is also possible to install a STAT serum index application (3 min).
p To install the serum index application
1
Download the application parameters for the serum index application (SI2).
u
See
Downloading application parameters (p. 538).
2
On Utility > Application , select the application L from the Test list.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-26 Analyze parameters on Utility > Application submenu (serum index tests)
3 Select the test SI2 from the Test list box.
This provides the link between the L , H , and I applications and the SI2 reagent.
549
18 Utility
Application submenu cobas® 8000 modular analyzer series q
4 Enter the factors for A to F into the text boxes. u
Please refer to the Instructions for Use for SI2 for the recommended values of the factors. o The recommended values for c 701 / c 702 are different from those for c 502 modules. The factors are identical for L , H , and I .
o The serum index application can only be run on c 70x modules or on c 502 modules because only one set of values can be entered.
q Application-specific limits in international units
Limits for L, H, and I index are implemented in conventional units in all application settings. When using the international units for the H and I index, the respective serum index limits have to be changed in all applications.
Please recalculate the H and I limits with the following factors:
H: Limit H (international units) = Limit H (conventional units) x 0.621
I: Limit I (international units) = Limit I (conventional units) x 17.1
5
Program the qualitative result reporting if desired.
6
Choose Save to save the changes.
7
Assign the application to a module.
u
See
Assigning a test to a module (p. 574).
8
Assign the S.IND
test to a test key.
Do not select the SI2 test for the key setting.
u
See
Assigning tests or profiles to test keys (p. 517).
9
Perform a blank calibration for the SI2 test.
u
See
Requesting and cancelling calibrations manually (p. 423).
s
Roche Diagnostics
550 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Description of application parameters
CAUTION
It is possible to change some of the default parameters installed with an application to suit individual laboratory practice. These procedures can be performed by operators with administrator level password only.
Incorrect results due to modifying application parameters
Changing an application setting may affect the validity of results.
r Check the new settings before using them. u
For instructions on changing default application parameters on the Analyze parameter group, see
To define application dilution ratios (e 602) (p. 552).
u
For instructions on changing default application parameters on the Calib.
parameter group, see:
To define calibration timeouts (p. 554)
To define application auto masking (p. 555)
To define the application duplicate limit (e 602) (p. 555)
u
For instructions on changing default application parameters on the Range parameter, see:
To define the number of decimal places (photometric and ISE tests) (p. 557)
To define application automatic rerun (p. 558)
To change the repeat limit (p. 561)
To change qualitative fields (photometric tests) (p. 561)
u
For information on calculated and compensated tests, see
Analyze parameters
The following sections explain certain settings associated with the Analyze parameters on Utility > Application submenu. Not all settings are described, but the most important ones are discussed here.
To display this submenu, select Utility > Application > Analyze .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-27 Analyze parameters on Utility > Application submenu (photometric tests)
551
18 Utility
Application submenu cobas® 8000 modular analyzer series
Figure 18-28 Analyze parameters on Utility > Application submenu (immune tests)
Dilution ratios (cobas e 602 module) p To define application dilution ratios (e 602)
1 Choose Utility > Application > Analyze .
2 Select the test to be edited from the Test list on the left.
3 In the Default Dilution Ratio area, select the dilution according to the package insert for the first run and for reruns.
Dilutions for the first run are rarely used if high concentrations can be expected in advance (e.g., only samples of tumor patients).
q A 2 selected from the list box represents a 1:2 dilution.
4
Repeat steps 2 and 3 for all necessary tests.
5 Choose Save to save the changes made.
s
Calib. parameters
The following sections explain certain settings associated with the Calib.
parameters on the Utility > Application submenu. Not all settings are described, but the most important ones are discussed here.
To display this submenu, select Utility > Application > Calib.
Roche Diagnostics
552 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Figure 18-29 Calib.
parameters on Utility > Application submenu (Photometric test)
Figure 18-30 Calib.
parameters on Utility > Application submenu (ISE test)
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-31 Calib.
parameters on Utility > Application submenu (Immune test)
553
18 Utility
Application submenu
Auto. Calibration cobas® 8000 modular analyzer series u
For instructions on changing default application parameters on the Calib.
parameters, see:
To define calibration timeouts (p. 554)
To define application auto masking (p. 555)
To define the application duplicate limit (e 602) (p. 555)
Calibration can be recommended automatically in various cases (see
Automatic calibrations (p. 415)). In the
Auto. Calibration area, the cause for automatic calibration request is defined for each application.
Roche Diagnostics
554
A B
A Photometric test B ISE tests
Figure 18-32 Auto. Calibration area u
For more information, see:
Automatic calibrations (p. 415)
To define calibration timeouts (p. 554)
C Immune test
C p To define calibration timeouts
1 Choose Utility > Application > Calib.
2 Select the test to be edited from the Test list on the left.
q For e 602 applications:
Before changing any settings, you must be familiar with the Instructions for Use of the application (available on cobas e-library).
The Timeout check box can be used to define time intervals for automatic calibration.
If the check box is not selected, a calibration timeout is not used.
3 In the Timeout area, define the required calibration method and the timeout period: o
For c module applications:
Select the calibration method for lot calibration from the corresponding list box.
Type the required timeout period for lot calibration in the corresponding text box and select the time unit from the corresponding list box.
Repeat the last two steps for the R. Pack calibration if necessary.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu o
For ISE applications:
Select the calibration method from the corresponding list box.
Type the required timeout period for ISE calibration, in days, in the corresponding text box.
o
For e 602 applications:
Select the Reagent Pack Stability check box and type the required timeout period for cobas e pack calibrations, in days, in the corresponding text box.
Select the Lot Stability check box and type the required timeout period for lot calibrations, in days, in the corresponding text box.
4 Choose Save to save the changes made.
s
Calibration masking (application-specific)
If the calibration of a test fails and Auto. Masking is selected, this test will be masked automatically.
u
For more information, see Calibration masking (auto masking) (p. 417).
q The Auto. Masking check box on Utility > System > Calib. and QC Settings must be selected to allow application-specific masking.
u
See: To activate the Auto. Masking function (p. 525)
p To define application auto masking
1 Choose Utility > Application > Calib.
2 Select the test to be edited from the Test list on the left.
3 Check the Auto. Masking check box to select the test for auto masking.
4
Repeat steps 2 and 3 for all necessary tests.
5 Choose Save to save the changes made.
s
Duplicate limit (cobas e 602 module)
Most of the Roche e 602 calibrators have a default duplicate limit of 10%. For some applications it is necessary to change the duplicate limit value. u
Please refer to the Instructions for Use.
p To define the application duplicate limit (e 602)
1
Choose Utility > Application > Calib .
2
Select the test to be edited from the Test list on the left.
3
Type the required duplication limit (0–64), expressed as a percentage (%), in the
Duplicate Limit text box.
4
Repeat steps 2 and 3 for all necessary tests.
5
Choose Save to save the changes.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
555
18 Utility
Application submenu
Range parameters
cobas® 8000 modular analyzer series
The following sections explain certain settings associated with the Range parameters on the Utility > Application submenu. Not all settings are described, but the most important ones are discussed here.
To display this submenu, select Utility > Application > Range
Figure 18-33 Range parameters on Utility > Application submenu (Photometric test)
Roche Diagnostics
556
Figure 18-34 Range parameters on Utility > Application submenu (ISE test)
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Figure 18-35 Range parameters on Utility > Application submenu (Immune test) u
For instructions on changing default application parameters on the Range tab, see:
To define the number of decimal places (photometric and ISE tests) (p. 557)
To define application automatic rerun (p. 558)
To program automatic QC measurements for timeout QC (p. 558)
To define the on-board stability for an auto QC (p. 559)
To change the repeat limit (p. 561)
To change qualitative fields (photometric tests) (p. 561)
Number of decimal places
The Decimal Places setting defines the number of digits (0 to 3) after the decimal point. This setting is applied to all results for this test.
For immunoassays, the number of decimal places is fixed and depends on the level of the test result. Four digits are used without decimal point and minus sign. Examples:
0.123 or 12.34 or 123.4 or 1234. p To define the number of decimal places (photometric and ISE tests)
1 Choose Utility > Application > Range .
2 Select the test to be edited from the Test list on the left.
3 Enter the number of digits in the Decimal places text box.
4 Choose Save to save the changes made.
From now on, results for this test will be reported with the changed number of decimal places. A new calibration is not required.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
557
18 Utility
Application submenu cobas® 8000 modular analyzer series
Automatic Rerun (application-specific)
If the Automatic Rerun check box is selected and if global automatic rerun is on, the test is automatically performed for rerun each time a result is flagged with a specific data alarm. p To define application automatic rerun
1
Choose Utility > Application > Range .
2
Select the test to be edited from the Test list on the left.
3
Select the Automatic Rerun check box.
4
Choose Save to save the changes made.
5
Make sure that Automatic Rerun is activated on the Start window.
u
For more information, see:
q If automatic rerun is selected, the sample remains on the module sample buffer until the results of the sample are available.
s
Configuring automatic QC
The Control Interval defines the time period (1 to 1000 hours) to run repeatedly controls for the selected test. At the end of the time period a QC measurement is automatically requested (cause: Timeout ) by the system.
p To program automatic QC measurements for timeout QC
1
Choose Utility > Application > Range .
2
Select the Control Interval check box for the relevant tests.
3
Specify a control interval from 1 to 1000 hours.
4
Assign control racks for auto QC.
u
See
To assign control racks for auto QC (p. 516).
When the specified time has elapsed, a QC recommendation is triggered. If an auto QC rack with a suitable control is located in the auto QC compartment, the system performs automatic QC measurements without any intervention by the operator. The control is measured with the active (in use) reagent packs.
s
Roche Diagnostics
558 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu p To define the on-board stability for an auto QC
1 Choose Utility > Application > Range .
2 Select the Auto QC On-Board Stability Time check box for the relevant tests.
3 Specify a time interval from 1 to 99 hours.
If auto QC racks are used and a control expires (on-board stability exceeded), the system displays a yellow alarm. The control cannot be used anymore and is indicated with a red bar on the QC > Status > Unloading window.
u
See
Unloading auto QC racks from the auto QC compartment (p. 465).
s
Technical limit
The technical limit reflects the measuring range within which the relation between measured signal and analyte concentration is well defined.
A lower and upper technical limit is set for each application. However, there are module-specific differences regarding the effects of the technical limit.
Result > technical limit
(>Test data alarm)
Result < technical limit
(<Test data alarm)
Photometric tests Immunoassays
Auto rerun with decreased volume possible
Auto rerun with decreased volume possible
(1)
Auto rerun with increased volume possible
No auto rerun possible
ISE tests
For ser/pl samples:
Auto rerun with normal volume
(15 μ L) is possible.
For urine samples:
Technical limit is not used for urine samples.
For ser/pl samples:
Auto rerun with normal volume is possible.
Table 18-16 Consequences if a result is outside technical limit
(1) The dilution ratio defined on Utility > Application > Range is used.
u
For more information, see:
Sample volumes for reruns (p. 494)
Photometric tests The Technical Limit is defined by Roche for each photometric application and must not be changed. The technical limit is transferred from the data manager.
For results above the upper technical limit (>Test data alarm), an automatic rerun with decreased sample volume can be performed. For results below the lower technical limit (<Test data alarm), an automatic rerun with increased sample volume can be performed.
Immunoassays The measuring range is fixed for each application although the technical limit is not displayed under Utility > Application > Range .
For results above the upper technical limit (>Test data alarm), an automatic rerun with decreased sample volume can be performed. For results below the lower technical limit (<Test data alarm), an automatic rerun cannot be performed.
Roche Diagnostics
Operator’s Manual · 4.2.1
559
18 Utility
Application submenu cobas® 8000 modular analyzer series
ISE tests For the sample type serum/plasma, the measuring range must be entered into the
Technical Limit boxes.
For urine samples, the technical limit is not required and not used as long as the default values (-99999 and 999999) are entered in the text boxes. If the result is outside the measuring range, the data alarm < >Test (ISE sample range over) is attached.
Measuring range (ser/pl)
Measuring range (urine)
Na
+
K
+
Cl
-
Na
+
K
Cl
+
-
80–180 mmol/L
1.5–10.0 mmol/L
60–140 mmol/L
20–350 mmol/L
(1)
3–100 mmol/L
20–350 mmol/L
(1)
(1) From 20–60 mmol/L, only increased sample volume (15 μ L) is effective.
If the result is above the upper technical limit (>Test data alarm), an automatic rerun with the same (normal) volume is possible. However, in most cases it is appropriate that you dilute the sample manually and repeat the measurement.
q For the sample types supernatant and CSF, the technical limit is not required.
p To enter the technical limit (only for ISE tests) q For photometric tests, the Technical Limit is defined by Roche and must not be changed.
1 Choose Utility > Application > Range .
2 Select the test to be edited from the Test list on the left.
3 In the first Technical Limit box, type the lower limit.
In the second box, type the upper limit.
4 Choose Save to save the changes.
s
Roche Diagnostics
560 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
Application submenu
Repeat limit
For each test, a clinically relevant range can be entered here. If the test result is outside this limit but inside the Technical Limit of the application, the test is repeated using the same sample volume and dilution as in the first run.
u
For more information, see Automatic reruns (p. 493).
p To change the repeat limit
1
Choose Utility > Application > Range .
2
Select the test to be edited from the Test list on the left.
3
In the first Repeat Limit box, type the lower limit of the range.
In the second box, type the upper limit of the range.
q For photometric tests, the concentration range of the Repeat Limit must be within the
Technical Limit .
4
Choose Save to save the changes.
s
Qualitative fields (photometric tests)
This function is important for DAT (drug abuse testing) in particular. Qualitative reporting can be chosen instead of quantitative reporting for each photometric test.
In the text boxes of the first column (1–5), the upper limit concentration range must be entered. Any result less than or equal to the value defined here will be printed with the text defined in the second box.
If a result is higher than range (5), the text defined in text box (6) is used. p To change qualitative fields (photometric tests)
1 Choose Utility > Application > Range .
2 Select the test to be edited from the Test list on the left.
3 Select the Qualitative check box to activate the qualitative fields.
4 Type the correct information in the first qualitative text box for (1).
5 Type the symbol that prints on the report in the second text box for (1).
6
for numbers (2) to (6).
7 Choose Save to save the changes.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
561
18 Utility
Application submenu
Other parameters
cobas® 8000 modular analyzer series
To display this submenu, select Utility > Application > Other .
Figure 18-36 Other parameters on Utility > Application submenu (photometric test)
Roche Diagnostics
562
Figure 18-37 Other parameters on Utility > Application submenu (ISE test)
This submenu provides additional information on calibrators.
Multiple position assignment for one calibrator code is possible ( Calibration
> Calibrators > Rack Assign ). When at least one rack position has been assigned to a standard, the Rack Assign area of the standard is displayed as Assigned .
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Formula parameters
To display this submenu, select Utility > Application > Formula .
18 Utility
Application submenu
Figure 18-38 Formula parameters on Utility > Application submenu
This submenu allows to enter formulas based on test results, for example, to program compensated tests.
q Compensated and calculated tests o Compensated tests can be programmed either on the instrument ( Utility
> Application > Formula ) or on the data manager ( Test Configuration > Test / reference ranges ).
o Calculated tests must be programmed on the data manager ( Test Configuration
> Test / reference ranges ). The result calculated by the instrument is neither interpreted nor displayed in the data manager.
Roche Diagnostics
Operator’s Manual · 4.2.1
563
18 Utility
Special Wash submenu
Special Wash submenu
cobas® 8000 modular analyzer series
The following sections explain certain settings associated with the Special Wash submenu. Not all settings are described, but the most important ones.
To display this submenu, select Utility > Special Wash .
Roche Diagnostics
564
Figure 18-39 Utility > Special Wash submenu
The cobas 8000 instrument is a random access system. Therefore, reagent probes and reaction cells may cause carryover and thus interferences between tests, and the sample probe may cause sample carryover.
To avoid carryover and cross-contamination between tests, use the special wash function. This function allows you to preset combinations of reagents or samples that may cause carryover so that washing will be carried out between them when the combination is encountered during analysis.
The special washes recommended for the installed applications can be downloaded from the data manager (via Utility > Special Wash > Download or via Overview
> Parameter Download > Special Wash > Download ). q Regularly download special wash settings using the Parameter Download function. Also observe the Carry over evasion list available on cobas link. This ensures the correctness and completeness of the programmed special washes for the installed applications.
Downloaded special wash settings are displayed in the Manufacturer Rule list.
Further special washes can be programmed and are displayed in the User Rule list.
u
The following sections explain how to set the carryover avoidance function.
Programming a special wash (photometric modules) (p. 565)
Programming a special wash (cobas e 602 module) (p. 570)
Installing special wash parameters (p. 572)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Programming a special wash (photometric modules)
Reagent probe, sample probe or cell washes may be required due to potential interference from other reagents or samples. These special washes maintain reagent and sample integrity.
Reagent probe wash
18 Utility
Special Wash submenu
The reagent probes dip into the reagents when aspirating. To avoid a reagent carryover, program a special wash cycle for the reagent probe.
p To program a reagent probe wash
1
Choose Utility > Special Wash > Reagent Probe .
Figure 18-40 Reagent Probe window (chemistry)
2
Select the desired photometric module from the Module Type list.
3
Select an empty line in the User Rule area list to add a reagent probe wash. To edit an existing reagent probe wash, select the corresponding line.
4
Choose Edit to display the Edit (Reagent Probe) window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-41 Edit (Reagent Probe) window (chemistry)
5 In the Probe list, select R1 or R2 to designate which reagent probe is to be washed.
6 In the From Reagent column: o Select the test name for the causal reagent in the Test list. o
Select the appropriate reagent type (R1, R2, or R3) in the Type list.
565
18 Utility
Special Wash submenu
Cell wash cobas® 8000 modular analyzer series
7 In the To Reagent column: o
Select the test name for the test concerned in the Test list. o
Select the appropriate reagent type (R1, R2, or R3) in the Type list.
8
In the Detergent column: o
Select the detergent (D1 = NaOH-D, D2 = SMS, D3 = SCCS, or water) used for washing in the Type list. o
Type the wash solution volume (from 20 to 180 μ L) in the Volume text box.
9 Choose OK to close the Edit (Reagent Probe) window and to add the special wash to the User Rule list.
10 To save the new special wash, select the check box left to the special wash and choose OK .
11 Check the amount of the appropriate detergent on the instrument on the Reagent
> Status submenu.
s p To delete a reagent probe wash
1
Choose Utility > Special Wash > Reagent Probe .
2
Select a module from the Module Type list.
3
Select the line(s) in the User Rule area to be deleted.
4
Choose Delete to delete the reagent probe wash after confirmation.
s
To avoid the carryover of traces of the test mixture from one test to the next test measured in that same reaction cell, program a special wash cycle for the reaction cell.
Roche Diagnostics
566 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series p To program a cell wash
1 Choose Utility > Special Wash > Cell .
18 Utility
Special Wash submenu
Figure 18-42 Cell window
2 Select a module from the Module Type list.
3 Select an empty line in the User Rule area to add a cell wash. To edit an existing cell wash, select the corresponding line.
4 Choose Edit to display the Edit (Cell) window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-43 Edit (Cell) window
5
Select a test from the Test list that may cause carryover.
q After Sampling area
For the HbA1c application, this window additionally shows the After Sampling area. In this area you can define special washes for reaction cells used for predilution of HbA1c whole blood tests. If selected, a special wash is carried out after the corresponding test was performed.
u
See
Installing and configuring the HbA1c application (p. 545).
6
In the R1 column: o
Select the detergent (D1 = NaOH-D, D2 = SMS, D3 = SCCS, or water) used for washing in the Type list. o Type the detergent volume (from 20 to 180 μ L) in the Volume text box.
7 Repeat step
R2/3 column.
8 Choose OK to close the Edit (Cell) window and to add the special wash to the
User Rule list.
567
18 Utility
Special Wash submenu
Sample probe wash cobas® 8000 modular analyzer series
9 To save the new special wash, select the check box left to the special wash and choose OK .
10 Check the amount of the appropriate detergent on the instrument on the Reagent
> Status submenu.
s p To delete a cell wash
1
Choose Utility > Special Wash > Cell .
2
Select a module from the Module Type list.
3
Select the test(s) to be deleted from the User Rule area.
4
Choose Delete to delete the cell wash after confirmation.
s
The sample probe dips into the sample to aspirate sample liquid. To avoid a carryover of sample liquid into a test that is sensitive to sample residue, program a special wash cycle for the sample probe. p To program a sample probe wash
1 Choose Utility > Special Wash > Sample Probe .
Roche Diagnostics
568
Figure 18-44 Sample Probe window
2 Select a sample type from the Sample Type list.
3 Select an empty line in the User Rule area to add a sample probe wash. To edit an existing sample probe wash, select the corresponding line.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
4 Choose Edit to display the Edit (Sample Probe) window.
18 Utility
Special Wash submenu
Figure 18-45 Edit (Sample Probe) window
5 From the Test list, select a test that is sensitive for sample residue.
6 Select the sample type from the S. Type list.
7 Select the detergent used for washing in the Type list.
These solutions are used for washing the sample probe.
o
SmpCln 1 o
SmpCln 2 o
SmpCln 1 + SmpCln 2 o
Water
The detergent aspiration volume is 60 μ L.
8
Choose OK to close the Edit (Sample Probe) window and to add the special wash to the User Rule list.
9
To save the new special wash, select the check box left to the special wash and choose OK .
10
Check that the appropriate wash solution is placed on the instrument in the correct position.
A B
A Position 1 = SmpCln 1 (basic wash)
B Position 2 = SmpCln 2 (acid wash)
Figure 18-46 Sample probe cleaners ( c 502 module for example)
11 Check the amount of the appropriate detergent on the Reagent > Status submenu.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
569
18 Utility
Special Wash submenu cobas® 8000 modular analyzer series p To delete a sample probe wash
1 Choose Utility > Special Wash > Sample Probe .
2 Select a sample type from the Sample Type list.
3 Select the test(s) to be deleted from the User Rule area.
4 Choose Delete to delete the sample probe wash after confirmation.
s
Programming a special wash (cobas e 602 module)
Use special wash programs for the e 602 reagent probe to avoid potential carryover of reagents or samples to other assays. Special washes maintain reagent and sample integrity.
Regularly use the download function for special washes. This ensures the correctness and completeness of the programmed special washes for the installed applications.
Reagent probe wash
The reagent probes dip into the reagents when aspirating. To avoid a reagent carryover, program a special wash cycle for the reagent probe.
p To program a reagent probe wash
1
Choose Utility > Special Wash > Reagent Probe .
Roche Diagnostics
570
Figure 18-47 Reagent Probe window (immune)
2
Select an e module from the Module Type list.
3
Select an empty line in the User Rule area list to add a reagent probe wash. To edit an existing reagent probe wash, select the corresponding line.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
4 Choose Edit to display the Edit (Reagent Probe) window.
18 Utility
Special Wash submenu
Sample probe wash
Figure 18-48 Edit (Reagent Probe) window (immune)
5 In the From Reagent column select the settings for the test from which contamination could be carried over to another test.
o
Select the name of the test from the Test list.
o
Select the pipetting step (0, 1 or 2) from the Step list.
O
Step0 : Pipetting step for pretreatment or diluent.
O
Step1 : Pipetting step before the first incubation.
O
Step2 : Pipetting step before the second incubation.
6 In the To Reagent column select the settings for the test to which contamination could be carried over from another test.
o
Select the name of the test from the Test list.
o
Select ON for the pipetting steps concerned (0, 1 or 2) from the corresponding
Step lists.
7
Choose OK to close the Edit (Reagent Probe) window and to add the special wash to the User Rule list.
8
To save the new special wash, select the check box left to the special wash and choose OK .
s
In the context of e 602 special washes, the term sample probe refers to the sample probe of a photometric module, not to the e 602 sample probe.
Prior to pipetting the photometric test, the sample probe of the c 701 / c 702 or c 502 is washed with the specified detergent if afterwards an e 602 test is requested.
q If a sample has been processed on a photometric module before an e 602 assay is performed and a special wash for the sample probe of the photometric module has been performed, a b-flag is displayed for this sample on the Data Review submenu.
u
See To program a sample probe wash (p. 568).
Roche Diagnostics
Operator’s Manual · 4.2.1
571
18 Utility
Special Wash submenu
Installing special wash parameters
cobas® 8000 modular analyzer series
Special wash parameters can be downloaded to the instrument from the data manager using the online support function.
Supervisors may download special wash parameters for the newest and current release of the same wash type and module type. Administrators may download any special wash parameters regardless of the currently installed release.
Update to newest release for the same wash type and module type
Download current release again
Download any parameters and release
Table 18-17
Supervisor l l
–
User rights for downloading special wash parameters l l
Administrator l p To install special wash parameters
1 Choose Utility > Special Wash > Download
Roche Diagnostics
572
Figure 18-49 Download window - special wash
2 Select one of the available search conditions ( All Item , Required Item , Module
Type , or Release Date ).
3 Choose Search . A list of items that meet the given search conditions appears in the list below.
4 Select the check box of each item to be downloaded.
5 Choose Download and confirm with OK .
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System Configuration submenu
System Configuration submenu
This section explains how to perform certain tasks associated with entire modules rather than specific samples or tests.
q The entire module set (module configuration, test assignment) should be set up before the other settings (control, calibrator settings)
To display this submenu, choose Utility > System Configuration .
This submenu can be accessed by operators with administrator level password only.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 18-50 System Configuration submenu
This submenu is used to access the Test Assignment , Module Settings , and CLAS
Settings windows.
u
Refer to the following procedures to get information about:
Assigning a test to a module (p. 574)
Powering off a module (p. 576)
For a detailed description of all elements on this submenu, please refer to the Online
Help.
573
18 Utility
System Configuration submenu
Assigning a test to a module
cobas® 8000 modular analyzer series
Use the following procedures to assign a test to the corresponding module.
u
For more information see:
To assign tests to the ISE module (p. 574)
To assign tests to a c module (p. 575)
To assign a test to an e 602 module (p. 576)
p To assign tests to the ISE module
1
Choose Test Assignment on the Utility > System Configuration submenu.
2
Choose the button of the ISE module. The Test Assignment (ISE) window is displayed.
Figure 18-51 Test Assignment (ISE) window
3 Select Na, K, Cl or Na, K .
o
Na, K, Cl : This option allows sodium (Na
+
), potassium (K
+
) and chloride
(Cl
-
) ion testing on this ISE module.
o Na, K : This option allows only sodium (Na) and potassium (K) testing on this
ISE module.
4 Choose OK .
s
Roche Diagnostics
574 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 18 Utility
System Configuration submenu p To assign tests to a c module
1 Choose Test Assignment on the Utility > System Configuration submenu.
2 Choose the button of the c module to which you want to assign the test. The module-specific Test Assignment window is displayed.
Roche Diagnostics
Operator’s Manual · 4.2.1
q
Figure 18-52 Test Assignment window – c 701 / c 702
3 Select a test in the Test list.
4 Select the Mandatory check box if the reagent must be on board all the time.
If the cobas c pack of a mandatory test is not available on the system, the corresponding reagent overview button of the module is displayed in red on the
Overview menu. Nevertheless, operation of the module can start.
5 Select the Reagent Disk A and / or Reagent Disk B check box to assign the test to the reagent disk A, B, or both.
The test list is updated immediately.
Unassigned tests are grayed. Tests assigned to a c 701 / c 702 module are followed by an A , B or AB , indicating they have been assigned to reagent disk A, B or both.
6 Choose OK .
s
575
18 Utility
System Configuration submenu cobas® 8000 modular analyzer series p To assign a test to an e 602 module
1 Choose Test Assignment on the Utility > System Configuration submenu.
2 Choose the button of the e module to which you want to assign the test. The module specific Test Assignment window is displayed.
q
Figure 18-53 Test Assignment window – e 602
3 Select a test in the Test list.
4 Select the Mandatory check box if the reagent must be on board all the time.
o If the cobas e pack of a mandatory test is not available on the system, the corresponding reagent overview button of the module is displayed in red on the
Overview menu. Nevertheless, operation of the module can start.
o A test that is not assigned to any of the channels must not be loaded on the system.
5
Select the Ch.1
and / or Ch.2
check box to assign the test to measuring channel 1,
2, or both.
The test list is updated immediately.
Unassigned tests are grayed. Tests assigned to an e 602 are followed by a 1 , 2 or B , indicating they have been assigned to measuring channel 1, 2 or both.
6
Choose OK .
s
Powering off a module
One or more modules can be powered of on Utility > System Configuration
> Module Settings . When a module is powered off, it cannot perform any automated maintenance functions.
q The instrument must be in Standby to activate or power off a module.
u
For more information, see To power off a specific module (p. 591).
Roche Diagnostics
576 Operator’s Manual · 4.2.1
Maintenance
cobas® 8000 modular analyzer series
Table of contents
19 Safety information for maintenance
Safety information for maintenance
19
This chapter contains safety information relevant when performing any maintenance on the cobas 8000 instrument. Be sure that you read and observe this safety information.
In this chapter
Chapter
19
Roche Diagnostics
Operator’s Manual · 4.2.1
579
19 Safety information for maintenance
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
580 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 19 Safety information for maintenance
General information
General information
Relevant safety messages r Make sure that you have read and understood the chapter
(p. 21). The following safety messages in particular are relevant:
r Warning messages: o
Electrical shock from electronic equipment (p. 27)
o
Infection from samples and associated materials (p. 27)
o
Infection and injury due to sharp objects (p. 27)
o
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
o
Infection from waste solution and solid waste (p. 28)
o
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r Caution messages: o
Personal injury due to contact with moving parts (p. 30)
r Observe the safety labels illustrated in section
Safety labels on the instrument (p. 35).
Before performing any maintenance, read the following safety messages carefully. If you ignore these safety messages, you may suffer serious or fatal injury.
Safety messages (overall system)
WARNING
WARNING
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in biohazardous contamination, resulting in personal injury and/or infection.
r Whenever possible, keep all covers of the analytical modules closed.
r If the maintenance item requires open covers while the instrument is powered on, always put the module in the appropriate maintenance mode first (e.g., power off).
r During cleaning and maintenance, be sure to wear appropriate protective equipment.
Carefully observe all instructions given in this manual. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.
r Do not open a cover while the instrument is performing maintenance.
r Observe in particular the following safety labels on the instrument:
T-1 (p. 38), T-8 (p. 38), T-11 (p. 38);
T-15 (p. 39), T-16 (p. 39), T-17 (p. 39), T-19 (p. 39);
F-2 (p. 41), F-5 (p. 41), F-9 (p. 41), F-10 (p. 41);
Fire and burns due to the use of alcohol
Alcohol is a flammable substance.
r Keep all sources of ignition (e.g. sparks, flames or heat) away from the instrument when conducting maintenance or checks using alcohol. r When using alcohol on or around the instrument, use no more than 20 mL at a time.
Roche Diagnostics
Operator’s Manual · 4.2.1
581
19 Safety information for maintenance
Safety messages (cobas ISE module)
CAUTION
NOTICE cobas® 8000 modular analyzer series
Malfunction due to spilled liquid
Any liquid spilled on the instrument may result in malfunction or damage of the instrument. r Do not place samples, reagents or any other liquid on the surface of the instrument.
r When removing and replacing the reaction cells, be careful not to spill water from the incubator bath.
r If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
r Observe in particular the following safety labels on the instrument:
Damage to the instrument due to tools left on the instrument
If the instrument power is turned ON when performing manual maintenance, parts or tools may contact the instrument mechanisms and damage the instrument. r Make sure no maintenance is being performed before supplying power to the instrument.
Safety messages (cobas ISE module)
CAUTION
Incorrect results due to missing covers of the ISE measuring compartments
If the covers of the ISE measuring compartments are not reinstalled after maintenance, the temperature may become inaccurate, leading to incorrect results.
r Only perform measurement, when the covers of the ISE measuring compartments are closed.
r
Observe in particular the following safety label on the instrument: T-4 (p. 38).
Roche Diagnostics
582 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Safety messages (photometric modules)
19 Safety information for maintenance
Safety messages (photometric modules)
WARNING
WARNING
NOTICE
Infection and injury when the top cover is open (c 702 only)
Contact with the reagent pack transfer mechanism or other mechanisms of the c 702 module may result in personal injury or infection. Therefore, the top cover is locked when the transfer mechanism moves.
r Before opening the c 702 top cover while the module is in Standby, check the
Reagent Manager Overview window to make sure that there are no reagent packs inside the buffer rotor of the reagent manager.
r Before starting operation or any software-controlled maintenance, be sure to close the top cover of the c 702 module. Otherwise operation would not start.
r After completing maintenance, be sure to close and lock the c 702 top cover.
Otherwise the reagent manager cannot load a reagent pack.
Personal injury due to contact with piercer (c 502 only)
A piercer for reagent packs is located next to the reagent probe R1. Contact with the piercer may result in personal injury. r Do not touch the piercer during cleaning.
r
Observe in particular the following safety label on the instrument: F-8 (p. 41).
Damage to the transfer mechanism for reagent packs (c 702 only)
Excessive weight on the transfer mechanism may lead to damage.
r Do not lean on the transfer mechanism for reagent packs.
r
Observe in particular the following safety label on the instrument: T-3 (p. 38).
Roche Diagnostics
Operator’s Manual · 4.2.1
583
19 Safety information for maintenance
Safety messages (cobas e 602 module)
Safety messages (cobas e 602 module)
cobas® 8000 modular analyzer series
CAUTION
NOTICE
Incorrect results due to missing covers of the e 602 reagent compartment or the incubator
If the covers of the reagent compartment or the incubator are not reinstalled after maintenance, the temperature may become inaccurate, leading to incorrect results.
r Only perform measurement, when the covers are closed.
r Observe in particular the following safety labels on the instrument:
Damage to the e 602 module due to the use of acid or alkaline solutions for cleaning
Do not use an acid solution or an alkaline solution to clean the Pre-wash mixer, the incubator, and the AssayCup vortex mixer. They are made of aluminum and these solutions degrade the metal. r Use deionized water only to clean these parts of the instrument.
r
Observe in particular the following safety label on the instrument: T-16 (p. 39).
Roche Diagnostics
584 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
General maintenance
Maintenance functions of the software
20 General maintenance
20
This chapter describes maintenance concepts of the cobas 8000 instrument. It explains the software functions that support you in performing maintenance, such as maintenance pipes and maintenance types. Lists of maintenance items and checks are also provided.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
20
Finalization pipe (after interruption of analysis).............................................. 604
Extended power ON (after 1–2 days powered off) .......................................... 604
Extended power ON (after 3–7 days powered off) .......................................... 605
585
20 General maintenance
Table of contents cobas® 8000 modular analyzer series
Maintenance schedules – weekly and longer intervals........................................... 621
Performing background maintenance (module masking) .................................... 626
Roche Diagnostics
586 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Overview
Overview
Personal injury or damage to the instrument due to non-observance of safety information r Before performing maintenance actions on any part of the instrument, read the safety notes for the corresponding maintenance item in the chapter
r It is the responsibility of the operator to properly care for and maintain the system to ensure consistent and accurate functioning. Modifying or omitting the maintenance procedures may result in a loss of performance or system reliability.
The Part
Maintenance (p. 577) contains the following chapters:
o
This is the current chapter. It describes the general maintenance concept and software functions, which support you in performing maintenance actions.
o
Module-specific maintenance chapters
These chapters contain all maintenance actions that must be performed on the specific modules, such as the core unit or the c 701 module.
u
See:
Maintenance of the core unit (p. 631)
Maintenance of cobas ISE module (p. 643)
Maintenance of photometric modules (p. 689)
Maintenance of cobas e 602 module (p. 761)
All of the software submenus shown in part Maintenance are used as examples only.
Your submenus may differ depending on your system setup.
Maintenance concepts
Principle
Requirements
Automation of maintenance tasks
Scheduling of periodic maintenance intervals
Table 20-1
Two maintenance categories can be distinguished: o
Manual maintenance actions (operator-controlled) o
Maintenance items and checks (software-controlled)
The following table explains the key facts about both categories.
Manual maintenance actions
Operator performs manual actions
Instrument usually powered off
(or in another appropriate status)
Not possible
Actions can be grouped into maintenance types for scheduling and tracking
Software-controlled maintenance items and checks
Maintenance items and checks performed from Utility > Maintenance
Usually started from Standby, covers must be closed
Items and checks can be grouped into maintenance pipes, which can be automated by maintenance pipe functions
Items and checks can be grouped into maintenance types for scheduling and tracking
Manual and software-controlled maintenance
Roche Diagnostics
Operator’s Manual · 4.2.1
587
20 General maintenance
Overview cobas® 8000 modular analyzer series
Performing maintenance items manually
Maintenance items can be performed manually from the Utility > Maintenance submenu.
Operator-controlled and user-definable maintenance items cannot be part of a maintenance pipe. Thus they have to be performed manually.
u
See Performing maintenance items (p. 594).
Maintenance pipes—performing maintenance items automatically
A maintenance pipe is a set of software-controlled maintenance items (batch set).
You can use a maintenance pipe so that certain maintenance items occur in a certain sequence.
Before usage, maintenance pipes must be defined under Utility > System > Pipe
Settings . Each pipe can have up to ten maintenance items including parameters belonging to them.
Maintenance pipes can be executed in two different ways: o
Manually by the user o
Automatically by means of maintenance pipe functions at these events:
O
When the instrument is switched on (Power Up Pipe function)
O
Before start of analysis (Start Up Pipe function) u
For more information on maintenance pipes, see
Maintenance types—scheduling and tracking maintenance items
Maintenance items and maintenance pipes can be grouped together in a maintenance type according to certain functions (such as daily or weekly maintenance).
Within a maintenance type, you can assign maintenance intervals (periods) and warning levels to each maintenance item and maintenance pipe. Thus, you can create and customize a maintenance schedule for every periodic maintenance task.
If a maintenance item or a maintenance pipe has been scheduled, you can track its status (date of last execution and warning level) on the Maintenance submenu. The status of maintenance types is also displayed on the Overview menu.
Maintenance types are configured on Utility > System > Maintenance .
u
For more information on defining and using maintenance types, see:
Defining and editing maintenance types (p. 606)
Maintenance report—recording maintenance
The instrument records the execution of maintenance items in the maintenance report. The maintenance report can be printed via Print (global button) > Utility
> Maintenance Report > History .
u
See Maintenance reports (p. 610).
Parallel and background maintenance
Various maintenance procedures can be performed in parallel, meaning that one module can be performing a maintenance item while another module is performing a different maintenance item. Maintenance procedures may also be performed in the background while the instrument is in Operation mode.
u
See Background and parallel maintenance (p. 624).
Roche Diagnostics
588 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Overview
Definitions
Maintenance item A single maintenance procedure. Maintenance items can be software-controlled or operator-controlled.
Software-controlled maintenance Maintenance items that are performed without operator interaction (such as (6) Air
Purge). The software-controlled items are included in the maintenance types
Maintenance and Check under Utility > Maintenance .
u
For a list of maintenance items, see List of maintenance items (p. 611).
Operator-controlled (manual) maintenance
Maintenance items that require operator interaction (such as Cleaning cell rinse nozzles (p. 699)).
User-definable maintenance Users may define their own maintenance items specific for their laboratory. Userdefinable maintenance items are always maintenance actions that have to be performed manually.
Maintenance pipe A combination of sequential maintenance items programmed into a fully automated procedure, which can be performed by the instrument without operator intervention.
Maintenance pipe function A function that automatically starts a maintenance pipe at a particular time (e.g., at power-up).
Maintenance type A set of maintenance items (software-controlled, operator-controlled and userdefinable) and maintenance pipes grouped according to certain functions (such as daily or weekly maintenance).
Operator and system times
In the chapters of part Maintenance the
operator time and the system time for each maintenance task are mentioned.
Operator time: The operator time is the estimated time that a trained person requires to perform this maintenance action on one module.
System time: The system time is the approximate time that the system requires to perform the required maintenance items. As most maintenance tasks can be performed in the same status, the time for powering off the instrument (approximately 2 minutes) and for switching the instrument on again (approximately 4:30 minutes) is not included in the calculation of the system time.
q The actual operator and system times may differ from the specified values, depending on the module configuration, degree of contamination, conditions of use, and other factors.
Roche Diagnostics
Operator’s Manual · 4.2.1
589
20 General maintenance
Overview
Instrument statuses for maintenance
CAUTION cobas® 8000 modular analyzer series
This section describes the most important statuses used for maintenance tasks.
Injury due to contact with instrument mechanism
Contact with the instrument mechanisms during cleaning or maintenance may result in personal injury. r Before opening a cover for cleaning or maintenance, always check the instrument status. Make sure that no maintenance item is currently performed.
r Keep all covers closed whenever performing a maintenance item or check. When it is necessary to keep it open, be careful not to touch any other than the aimed-at part.
r Make sure that the module is masked or the instrument is in Standby before executing a maintenance item or check.
r Before replacing any parts, be sure to power off the instrument or the module.
Standby and module masked
Standby Software-controlled maintenance items and checks can only be performed when the instrument is in Standby, or when the desired module is masked.
Module masked When a module is masked, the status of this module changes to Standby while operation can be performed on other modules ( background maintenance ).
Choose Start (global button) > Masking > Module Masking . The module completes any samples assigned to it prior to masking, goes into S. Stop (sampling stop) mode and then to Standby.
u
For more information, see To perform background maintenance (p. 627).
Power off and module power off
Power off Analytical module(s) and control unit are disconnected and the operation power switch is switched off. Power for keeping the reagents and auto QC controls cool, however, is still supplied.
u
For information about switching the instrument on and off, see:
To power off the instrument (p. 293)
To manually start up the instrument (p. 273)
Module Power Off By means of the Module Power Off status, you can turn off power supply for selected modules for maintenance purposes (e.g., replacement of parts).
After powering off the module by software, turn off the module power switch at the rear of the module. This ensures that nobody else operates at the module by mistake while you are performing maintenance.
Roche Diagnostics
590 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Overview p To power off a specific module
1 Make sure that the complete instrument is in Standby or the module is masked and in Standby.
2 Choose Utility > System Configuration > Module Settings .
CAUTION
Figure 20-1 Module Settings window
3 Select the desired module from the system layout to be powered off.
4 Choose OK to apply the assigned settings.
5 Turn off the module power switch at the rear of the module.
Injury when the system is restarted accidentally
If the instrument is restarted accidentally by a third person during replacement of parts, this may cause injury or damage to the system. r Before replacing any parts, be sure to power off the instrument or the module.
6
You may now perform any of the manual maintenance tasks listed in the maintenance schedules.
u
See
Combined maintenance schedules (all modules) (p. 619).
s p To power on a specific module
1
Switch on the module power switch at the rear of the module.
2
Choose Utility > System Configuration > Module Settings to switch selected modules to the Active status.
q Wait at least for about one minute before resuming operation.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
591
20 General maintenance
Overview
Manual cleaning cobas® 8000 modular analyzer series
The motors of the selected module are switched off. Use this maintenance item to move different parts manually for cleaning purposes, such as the pipetter probes, without having to power off the instrument.
p To put a module in Manual Cleaning mode
1
Make sure that the complete instrument is in Standby or the module is masked and in Standby.
2
Choose Utility > Maintenance > (11) Manual Cleaning .
3
Choose Select to open the Manual Cleaning window.
Roche Diagnostics
592 q
Figure 20-2 Manual Cleaning window
4
Deselect the ISE and any c 502 modules. These modules have an interlock cover that allows the probes to be moved for cleaning when the top cover is opened.
Note that the ISE and the first module cannot be selected at the same time for manual cleaning.
5
Choose Execute . The probes on the selected modules move to their cleaning positions.
6
Choose Maintenance Monitor to check that the module is in Manual Cleaning mode.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series p To terminate Manual Cleaning mode
1 Choose Overview .
2 Select the button of the desired module.
The Module window is displayed.
20 General maintenance
Overview
CAUTION q
Figure 20-3 Module window
3
Select Cancel Maintenance .
4
Confirm with OK to stop Manual Cleaning mode.
5
Choose Utility > Maintenance > (1) Reset .
6
To select only particular modules, clear the SU check box.
7
Select the affected module and choose Execute .
8
On c 701 and c 702 modules, additionally perform a reagent registration via
Reagent > Setting > Reagent Registration .
Instead of starting the reagent registration manually, you can include it in a maintenance pipe together with the (1) Reset.
s p To terminate Manual Cleaning mode (using Stop button)
Interrupt of operation
Pressing the Stop (global button) would stop all functions on all modules. All pipetted samples would be lost and must be reloaded.
r Choose Cancel Maintenance to terminate Manual Cleaning mode.
r Choose Stop (global button) only if no other module is operating or performing background maintenance.
1 Choose Stop (global button) only in case all other modules are in Standby.
2 Choose Utility > Maintenance > (1) Reset .
3 To select only a particular module, clear the SU check box.
4 Select the affected module and choose Execute .
5 On c 701 and c 702 modules, additionally perform a reagent registration via
Reagent > Setting > Reagent Registration .
s
Roche Diagnostics
Operator’s Manual · 4.2.1
593
20 General maintenance
Maintenance items
Maintenance items
cobas® 8000 modular analyzer series
Maintenance items and checks can be performed as single items or grouped together to a maintenance pipe.
Performing maintenance items
This section describes how to perform a single maintenance item or check.
u
For information about the available maintenance items, see:
List of maintenance items (p. 611)
List of maintenance checks (p. 616)
p To execute a maintenance item
1
Choose Utility > Maintenance to display the Maintenance submenu.
Roche Diagnostics
594
Figure 20-4 Maintenance submenu
2 Choose an entry from the Maintenance Type list.
o
The entries Maintenance and Check are predefined. They include only maintenance items, no pipes.
o A self-defined maintenance type can include both: Maintenance items and maintenance pipes.
3 Select the maintenance item from the Maintenance list on the right.
4 Choose Select .
5 Define all required parameters and choose Execute .
The date of execution will be updated even if operation is interrupted due to an alarm, etc. In this case, repeat the relevant maintenance item and terminate it normally.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes
Maintenance pipes
A maintenance pipe is a set of software-controlled maintenance items (batch set).
Using maintenance pipes saves time by allowing the system to perform a series of maintenance items without operator intervention.
Be aware of the relation between maintenance pipes and maintenance pipe functions :
Maintenance pipes Before usage, maintenance pipes must be defined under Utility > System
> Pipe Settings . The name of a pipe is freely definable, e.g., Daily pipe .
Roche recommends using maintenance pipes for automating instrument care, but there are no pre-defined pipes on the system by default. u
For more information, see:
Defining and editing maintenance pipes (p. 596)
Recommended maintenance pipes (p. 603)
Maintenance pipes can be executed manually by the user. Alternatively, they can be executed automatically by means of maintenance pipe functions .
Maintenance pipe functions A maintenance pipe function triggers the system to start a maintenance pipe at one of these events: o
At power-up ( Power Up Pipe function) o
Before start of analysis ( Start Up Pipe function) o
Before powering off the instrument after the last maintenance item is completed
( Power Off Pipe function) u
See Using maintenance pipe functions (p. 599).
Roche Diagnostics
Operator’s Manual · 4.2.1
595
20 General maintenance
Maintenance pipes cobas® 8000 modular analyzer series
Example The Daily pipe
e.g., to the Power Up Pipe function. In the latter case, the pipe function will automatically start the maintenance pipe at power-up.
0DLQWHQDQFHSLSH
'DLO\SLSH
‡$LU3XUJH
‡,QFXEDWLRQ:DWHU([FKDQJH
‡5HDJHQW3ULPH
‡3KRWRPHWHU&KHFN
0DQXDORUDXWRPDWLF
H[HFXWLRQ"
0DQXDOH[HFXWLRQ $XWRPDWLFH[HFXWLRQ
0DLQWHQDQFHSLSHIXQFWLRQV
‡3RZHU8S3LSHIXQFWLRQ
‡6WDUW8S3LSHIXQFWLRQ
Figure 20-5 Example of maintenance pipes and maintenance pipe functions q Pipes and pipe functions o Daily pipe is used as a name for a maintenance pipe . (This name is freely definable.) o Power Up Pipe is a fixed name of a maintenance pipe function .
The following sections describe how maintenance pipes are defined, executed, and deleted.
Defining and editing maintenance pipes
Use the following procedure to program a series of maintenance items into a specific maintenance pipe. Up to ten items can be defined in each pipe. When a maintenance item is performed as part of a pipe, an asterisk appears on the left side of the date on the Maintenance Report.
u
See Maintenance reports (p. 610).
Roche Diagnostics
596 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes p To edit a maintenance pipe or to define a new pipe
1 Choose Utility > System > Pipe Settings to display the Pipe Settings window.
Figure 20-6 Pipe Settings window
2 To edit an existing pipe, choose its name in the Pipe list. Or choose a blank line in the Pipe list to define a new pipe.
3 Choose Edit to display the Edit window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 20-7 Edit window
597
20 General maintenance
Maintenance pipes cobas® 8000 modular analyzer series q
4 Type an unused name for the new pipe in the Pipe Name text box or edit the name of the existing pipe if you want to change its name. o
Select the Power Off check box to power off the instrument after the maintenance pipe is completed.
o
Select the Wash Rack check box to execute washing with a green wash rack.
Load the green wash rack into the rack loading area. The items of this maintenance pipe will be executed after the washing procedure.
o
Select the Reagent Registration check box to register reagents on c 701/ c 702 modules and to perform the maintenance item (27) Inventory Update on e 602 modules after the maintenance pipe.
Reagent registration is necessary on c 701/ c 702 modules, for example, after using Manual Cleaning mode or if you want to perform a maintenance item that requires reagents (e.g., (5) Incubation Water Exchange). With this pipe, you do not need to start reagent registration manually. If the reagent registration was already performed before, it is skipped in the maintenance pipe.
o
Select one of the other check boxes to include the corresponding maintenance items or checks at the end of the maintenance pipe.
u
See:
(27) Inventory Update (p. 614)
(25) Urgent Information (p. 618)
(26) Essential Information Upload (p. 618)
5 Add a maintenance item to the Pipe Items list by choosing the maintenance item on the Maintenance list, then choose Add .
6 Choose Parameter to select specific modules or to define the parameters such as the number of cycles to be performed depending on the maintenance item highlighted.
u
For more information about the parameters of a specific maintenance item, please refer to the Online Help for that particular window.
7
for all items that are to be included in the pipe.
8 Delete items from the pipe by choosing the appropriate item on the Pipe Items list, then choose Remove .
Items must be listed in the order of execution. If the items are not in the desired order, choose the item to be moved to highlight it, then choose the appropriate Up or Down arrow button to move the item up or down in the list.
9 Choose OK when the pipe settings are complete.
The pipe then appears in the Pipe list on the Pipe Settings window. It also appears as an option under Utility > System > Pipe Settings .
s
Roche Diagnostics
598 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes
Performing maintenance pipes
The pipe must have been defined as a maintenance type first.
u
See Defining and editing maintenance types (p. 606).
p To execute a maintenance pipe
1
Choose Utility > Maintenance .
2
Follow the procedure to execute a maintenance item (pipes are performed just like items).
u
See
To execute a maintenance item (p. 594).
The maintenance pipe is performed. The date of the maintenance pipe is updated.
If the pipe is defined as a Power Off pipe, the instrument will be powered off after the pipe has been completed.
s
Deleting maintenance pipes
p To delete a maintenance pipe
1 Choose Utility > System > Pipe Settings .
2 In the Pipe list, select the name of the pipe to be deleted.
3 Choose Delete and confirm with Yes to delete the maintenance pipe.
s
Using maintenance pipe functions
Maintenance pipes can be performed automatically by the system by means of maintenance pipe functions. The system provides three maintenance pipe functions, which are described in the following.
u
For general information and an example, see
Power Up Pipe function
Use the Power Up Pipe function to select a pipe to be performed at power up of the instrument. Regardless of whether the instrument is powered on manually or automatically by the time switch, the selected pipe is performed after the initialization process.
Roche Diagnostics
Operator’s Manual · 4.2.1
599
20 General maintenance
Maintenance pipes cobas® 8000 modular analyzer series p To activate a Power Up pipe function
1 Choose Utility > System > Pipe Settings > Power Up Pipe .
q
Figure 20-8 Power Up Pipe window
2 Select the pipe to be performed at power up for each day of the week.
3 Choose OK .
If you want to power on the instrument automatically at a specified time, set the time switch at the core unit.
The analytical units will be initialized 10 minutes before the specified time. The maintenance pipe will be performed afterwards.
u
See:
Setting the date and time (p. 487).
s
Roche Diagnostics
600 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes
Start Up Pipe function
The Start Up Pipe function is used to automatically perform a selected pipe before the start of an analysis run.
p To activate a Start Up Pipe function
1
Choose Start (global button) or press the F2 key to open the Start window.
Figure 20-9 Start window (barcode mode)
The Start Up Pipe Setting area displays the maintenance pipe currently selected as Start Up pipe. If no maintenance pipe is selected, Cancel is displayed.
2
Choose Change in the Start Up Pipe Setting area.
3
Select the desired start up pipe.
4
Choose OK to accept the change.
5
Choose Start to perform the displayed pipe.
After completion of the start up pipe, analysis will be started automatically.
s
Power Off Pipe function
The Power Off Pipe function makes it possible to power off the instrument after the pipe has been performed. If the Power Off Pipe function is not activated ( Power Off check box is not selected), the instrument returns to Standby when a pipe is completed.
p To activate the Power Off Pipe function
1 Choose Utility > System > Pipe Settings to display the Pipe Settings window.
2 In the Pipe list, choose the pipe to be performed as the power off pipe.
Roche Diagnostics
Operator’s Manual · 4.2.1
601
20 General maintenance
Maintenance pipes cobas® 8000 modular analyzer series
3 Choose Edit to display the Edit window.
Roche Diagnostics
602
Figure 20-10 Edit window
4 Select the Power Off check box to activate the Power Off Pipe function.
o
The instrument will be powered off automatically after the pipe is completed.
o
Select the Wash Rack check box to execute washing with a green wash rack.
Load the green wash rack into the rack loading area. The items of this maintenance pipe will be executed after the washing procedure.
o
Select one of the other check boxes to include the corresponding maintenance items or checks at the end of the maintenance pipe.
u
See:
(25) Urgent Information (p. 618)
(26) Essential Information Upload (p. 618)
5
Choose OK to save the settings and return to the Pipe Settings window.
u
See
Recommended maintenance pipes (p. 603)
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes
Recommended maintenance pipes
A maintenance pipe is a set of software-controlled maintenance items. This section shows the maintenance pipes that Roche recommends for proper use of the instrument. The maintenance items must be programmed in the order listed here for the pipe to be performed correctly.
Automating instrument care We recommend using the maintenance pipe functions to perform maintenance pipes automatically. u
For information about maintenance pipes and maintenance pipe functions, see:
Defining and editing maintenance pipes (p. 596)
Using maintenance pipe functions (p. 599)
Daily pipe
We recommend performing this maintenance pipe by means of a maintenance pipe function – either after initialization of the instrument (Power Up Pipe function) or before start of analysis (Start Up Pipe function). q Visual checks at power ON
Note that even though a maintenance pipe can be executed automatically, some of the maintenance items listed below require visual checks with the top cover closed.
Maintenance Item
ALL
Visual checks
With top covers closed, visually check that water is being discharged at all rinse stations as well as through sample probes and reagent probes.
After air purge (in Standby mode), visually check the syringes and the tubing system for leakage and air bubbles.
–
Module
ISE c 701 / c 702
for ISE –
Check the photometer values via Print > History .
c 701 / c 702 / c 502
ISE c 701 / c 702 / c 502
Table 20-2 Recommended maintenance pipe — Power ON q o Before starting routine operation, check that the incubator has reached the correct temperature (37 ± 0.1 °C) on the Overview menu.
Depending on the ambient temperature, this may take up to 30 minutes after switching on the instrument or after maintenance item (5) Incubation Water Exchange until the temperature is reached.
o If a green wash rack is processed in the Daily pipe, it is not necessary to perform the maintenance item (8) Reagent Prime.
Roche Diagnostics
Operator’s Manual · 4.2.1
603
20 General maintenance
Maintenance pipes
Weekly pipe cobas® 8000 modular analyzer series
We recommend performing this maintenance pipe every week either before powering off or after starting up ( Power Off Pipe function or Power Up Pipe function).
Module c 701 / c 702 / c 502
Table 20-3
Maintenance Item
(7) Wash Reaction Parts, NaOH-D pack (D1) required.
Complete description: Washing the reaction parts (p. 702)
Recommended maintenance pipe — Weekly
q Before you power off the instrument, check the cell blank values under Print > Utility
> Cell Blank Measurement > Preview > History . The values will be lost after power off.
Finalization pipe (after interruption of analysis)
If an analysis run on the e 602 module was interrupted, the following maintenance pipe must be executed.
Module e 602
Table 20-4
Maintenance Item
Reagent
Finalization pipe
Cycles
1
Extended power ON (after 1–2 days powered off)
Module e 602
Table 20-5
Maintenance Item
(8) Reagent Prime, select Pre-wash sipper
(24) MC Preparation (5 cycles)
Extended power ON 1
Extended power OFF (for 3–7 days)
Module e 602
Cycles
5
5
5
Table 20-6
Maintenance Item
(8) Reagent Prime, select Reagent
(8) Reagent Prime, select Pre-wash sipper
Extended power OFF 2
Cycles
5
-
10
1
1
5
Roche Diagnostics
604 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance pipes
Extended power ON (after 3–7 days powered off)
Module e 602
Table 20-7
Maintenance Item
(8) Reagent Prime, select Reagent
(8) Reagent Prime, select Pre-wash sipper
Extended power ON 2
Cycles
5
5
30
5
Roche Diagnostics
Operator’s Manual · 4.2.1
605
20 General maintenance
Maintenance types
Maintenance types
cobas® 8000 modular analyzer series
Maintenance items and maintenance pipes can be grouped together into a maintenance type according to certain functions (such as daily, weekly, or monthly maintenance).
By using maintenance types, you can create a maintenance schedule. A maintenance interval can be assigned to each maintenance item and maintenance pipe within a maintenance type.
Predefined maintenance types Two maintenance types are predefined: Maintenance and Check .
o
Maintenance : Contains all available maintenance items except check routines.
o
Check : Contains all check routines.
Maintenance intervals Intervals can be determined for each maintenance item or maintenance pipe. An overdue maintenance item or pipe will be indicated in yellow or red (depending on criticality) on the Maintenance submenu: o
Indication in yellow: Warning level o
Indication in red: Overdue
Defining and editing maintenance types
Use the following procedure to group a series of maintenance items into a specific maintenance type.
p To edit a maintenance type or define a new type
1
Choose Utility > System > Maintenance Settings .
Roche Diagnostics
606
Figure 20-11 Maintenance Settings window
2
If a new maintenance type is to be defined, select a free line from the
Maintenance Type list, choose Edit
If an existing maintenance type is to be edited, select the appropriate line from the
Maintenance Type list, choose Edit
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance types
3 Enter a name for the maintenance type in the text box at the top of the window.
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Name of a maintenance item or pipe
Figure 20-12 Edit window
4 Select an item from the Maintenance Name list box (
This list includes maintenance items and checks as well as user-defined maintenance pipes (e.g., your morning pipe). Additionally, you can define your own maintenance items by selecting User Definable from the list. User-definable maintenance items allow to monitor the intervals for manual maintenance actions.
Different parameter options are available for some maintenance items (service level access required). Please contact either your Roche service representative or technical support to define parameter options for pipes.
u
For information about available maintenance parameters, refer to the Online Help for that particular window.
5 To specify a maintenance interval, select the Period check box and fill out the corresponding boxes.
6 Select a timer function from the list box on the right: o
Realtime : The actual time o
Power On : Cumulative power-on time of the instrument o
Operation : Cumulative operation time
Power-On time and Operation time are both listed on the Maintenance
Report.
u
See
7 Enter the warning level (%) in the Warning Level text box.
Example:
If you define a period of 10 hours in real time and a warning level of 90 %, the instrument will remind you to perform the maintenance item after 9 hours.
8 By selecting the Comment check box you can add a comment during execution that will be printed out on the Maintenance Report.
9 Choose Update to add the item to the Maintenance list on the left.
10
for all items of the maintenance type.
607
20 General maintenance
Maintenance types cobas® 8000 modular analyzer series
11 Choose OK to save the settings.
12 Choose Close to close the Maintenance Settings window.
s
Tracking maintenance
If you have assigned a maintenance interval to a maintenance item or a maintenance pipe within a maintenance type, the instrument reminds you when a maintenance item or pipe is due.
Maintenance tracking is done on the Maintenance submenu. The status of maintenance actions is also displayed on the Overview menu.
More detailed information about the status of a particular maintenance type can be displayed on the Maintenance Monitor window.
u
For more information about the Maintenance Monitor window, refer to the Online Help for that particular window.
p To display the maintenance status
1
Choose Utility > Maintenance .
Roche Diagnostics
608
Figure 20-13 Maintenance submenu
The Date/Time column displays when the execution of the maintenance item or pipe was last requested. The following colors are used in this submenu:
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Maintenance types
Column
Maintenance
Type
Date/Time
Table 20-8
Color Meaning
Yellow
Red
A maintenance item or pipe of this maintenance type exceeded its warning level.
A maintenance item or pipe of this maintenance type exceeded its maintenance interval.
Yellow
Red
This maintenance item or pipe exceeded its warning level.
This maintenance item or pipe exceeded its maintenance interval.
Color scheme for the Maintenance submenu
2 If you need more information about the status of a particular maintenance type, select the maintenance type from the left list and then the maintenance item or pipe from the right list.
3 Choose Maintenance Monitor to view the status of the selected maintenance item or pipe.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
609
20 General maintenance
Maintenance reports
Maintenance reports
cobas® 8000 modular analyzer series
The instrument records the execution of maintenance items. The Maintenance
Report lists the execution times for all maintenance items.
u
For more information about the Maintenance Report , please refer to the Online Help for that particular report.
Printing maintenance reports
p To print a Maintenance Report
1
Choose Print (global button) > Utility > Maintenance Report .
2
Select the desired options in the center of the screen.
3
Choose Preview . The icon on the Print button starts flashing.
4
When the icon has stopped flashing, choose History .
5
Check that the desired report is selected.
6
Choose Print Out .
Power On Time
Operation Time
Maintenance Type :
Module :
Maintenance
C7-1
Cell Detergent Prime
Date
* 2009/06/24
Time Operator ID
09:29:44 bmserv
* 2009/06/23
* 2009/06/23
* 2009/06/22
* 2009/06/19
* 2009/06/18
* 2009/06/17
17:31:00
08:51:58
06:39:55
09:25:31
06:39:04
07:54:16
SYSTEM bmserv
SYSTEM
SYSTEM
SYSTEM
SYSTEM
* 2009/06/16
* 2009/06/11
* 2009/06/09
* 2009/06/08
* 2009/06/05
* 2009/06/04
* 2009/06/04
* 2009/06/03
* 2009/06/02
08:54:06
06:38:55
06:39:02
06:42:41
09:19:22
16:27:24
11:22:36
09:45:26
07:53:30
SYSTEM
SYSTEM
SYSTEM
296
44
Operator ID: admin
Hours
Hours
Comment
2009/09/16 16:27 q
Figure 20-14 Example of a Maintenance Report o To print out a report for a certain maintenance item, choose Utility
> Maintenance and select the desired maintenance item before starting with step 1.
o When a maintenance item was performed as a part of a pipe, an asterisk appears on the left side of the date on the Maintenance Report.
s
Roche Diagnostics
610 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
List of maintenance items
List of maintenance items
CAUTION
This section contains a brief description of all maintenance items listed under Utility
> Maintenance > 1 Maintenance .
ISE, c 701 / c 702, c 502, e 602
Core
MSB
Denotes the module to which this maintenance item applies.
Core unit (rack loading/unloading area and conveyor)
Module sample buffer
Injury due to contact with instrument mechanism
Contact with the instrument mechanisms during maintenance may result in personal injury.
r Keep all covers closed whenever performing one of the maintenance items or checks listed below. When it is necessary to keep it open, be careful not to touch any other than the aimed-at part.
r Make sure that the module is masked or the instrument is in Standby before executing a maintenance item or check.
q System times for maintenance items
The time required for a specific maintenance item depends on the module configuration, the software version, and the selected settings. Choose Maintenance Monitor to display the required time for most of the maintenance items.
(1) Reset Mechanical parts of the selected modules are reset to their home positions.
If the SU check box is selected, the mechanical parts of all modules are reset to their home positions and all racks are transported to the unloading area.
To reset particular modules, clear the SU check box first.
(2) Rack Reset Core, MSB: Mechanical parts are reset to their home positions, all racks including
STAT racks are transported to the unloading area. Auto QC racks and racks in the sample buffer will remain in the module sample buffers unless the corresponding check boxes are selected.
(3) Photometer Check c 701 / c 702, c 502: Photometer output is checked by measuring a water blank of cell no. 1.
Check the photometer values on Print > History > Photometer Check .
Measurement results must be below 14 000. If results are higher, check the light path; if necessary, replace the photometer lamp, then perform a cell blank measurement.
Before performing this maintenance item, check that the incubator temperature is within 37 ± 0.1 °C on the Overview menu.
Depending on the ambient temperature, it can take up to 30 minutes after switching on the instrument or after maintenance item (5) Incubation Water Exchange for the incubator to reach the correct temperature.
u
See To check the light intensity (p. 734).
(4) Cell Blank Measurement c 701 / c 702, c 502: Water blank values of all cells are measured. If there is a difference greater than 0.1 absorbance units in the results for one cell compared to cell no. 1, that cell number is written to the Cell Blank Measurement report in the section Abnormal Cell List . To view this list, choose Print > History .
Roche Diagnostics
Operator’s Manual · 4.2.1
611
20 General maintenance
List of maintenance items cobas® 8000 modular analyzer series u
For information about the cell blank measurement, see:
To perform a cell blank measurement (p. 703)
To view the cell blank measurement results (p. 703)
(5) Incubation Water Exchange c 701 / c 702, c 502: Incubator bath water is exchanged and Ecotergent is added. The incubator bath is also referred to as reaction bath (see also the abbreviation Reac.
on the Overview menu).
The water exchange rate for this maintenance item can be set to a high or low rate on
Utility > System > Analyzer Settings .
After this maintenance item has been performed, check that the incubator temperature is within 37 ± 0.1 °C on the Overview menu before performing maintenance item (3) Photometer Check. Depending on the ambient temperature, it can take up to 30 minutes for the incubator to reach the correct temperature.
(6) Air Purge ISE, c 701 / c 702, c 502: All air which may have become trapped in the sample and reagent syringes is purged. Water as well as all air are discharged at the rinse stations.
With top cover closed, visually check that water is dispensed from the sample probe and/or the reagent probe in a straight flow.
After air purge (in Standby mode), visually check the syringes and the tubing system for leakage and air bubbles. u
See:
To perform an air purge and check the operation of the probe (p. 685) (ISE)
To perform an air purge and check the operation of the probe (p. 754) (
c 701 / c 702, c 502)
(7) Wash Reaction Parts c 701 / c 702, c 502: The reagent probes and all reaction cells are washed with detergent D1 (NAOHD) from reagent packs (approx. 2 × 72 mL for c 701 / c 702 and approx. 58 mL for c 502).
For more information, please refer to the Instructions for Use of the application.
u
See To wash the reaction system (p. 702).
(8) Reagent Prime ISE: Reagents are primed according to the option chosen (default: ALL, 20 cycles).
Reagent consumption 400 μ L per cycle.
Whenever you replace any ISE reagent container, a reagent volume reset, a reagent prime, and an ISE calibration must be carried out. u
For the REF option, see:
To prime and calibrate the ISE module (p. 664)
For the ALL option, see:
To prime lines and check connections (p. 668).
e 602: The Pre-wash sippers and PreClean lines ( Pre-wash sipper option) or
ProCell/CleanCell reagent lines ( Reagent option) are primed. In the latter case, the reagent lines are purged of air and the ProCell and CleanCell reservoirs are refilled.
(9) Cell Detergent Prime c 701 / c 702, c 502: Reagent lines for cell cleaner solution (CellCln 1 and CellCln 2) are primed; reagent lines are purged of air and cells are filled up and emptied by vacuum. u
See To perform a cell detergent prime (p. 726).
Roche Diagnostics
612 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
List of maintenance items
(10) Incubator Bath Cleaning c 701 / c 702, c 502: Performs transition to the Incubator Bath Cleaning mode: The photometer lamp is switched off and the incubator bath water is automatically drained.
To terminate the Incubator Bath Cleaning mode, press the F1 button ( c 701 / c 702 module); for the c 502 module, choose Continue from the Confirmation window.
Then the incubator bath is automatically refilled with water. Afterwards, Ecotergent is added to the water and the instrument returns to Standby.
u
For more information, see:
To remove reaction cells and to clean the incubator bath (c 502 module) (p. 720)
To clean the surface of the ultrasonic mixer (c 701 / c 702 modules) (p. 729)
(11) Manual Cleaning c 701 / c 702, c 502, e 602: In this mode, the motors of the selected module are switched off. Use this mode to move different parts manually for cleaning purposes, such as the pipetter probes, without having to power off the instrument.
If the SU check box is selected, all modules are put into Manual Cleaning mode. Clear the SU check box to select particular modules.
To terminate Manual Cleaning mode for a module, choose the corresponding Cancel
Maintenance button from the Overview menu. Only in case no other module is operating or performing background maintenance, you may also choose Stop to terminate Manual Cleaning mode on all modules.
After manual cleaning, a reagent registration via Reagent > Setting > Reagent
Registration is required for c 701 / c 702 modules. Instead of performing the reagent registration manually, you can include it in a maintenance pipe.
u
For more information, see:
To put a module in Manual Cleaning mode (p. 592)
To terminate Manual Cleaning mode (p. 593)
(12) Change Reaction Cell c 701 / c 702, c 502: The motor of the reaction disk of the specified module is switched off and the reaction disk can be moved freely. Use this item to exchange reaction cells without having to power off the instrument.
(13) Change Photometer Lamp c 701 / c 702, c 502: The photometer lamp is switched off. Use this item to exchange the photometer lamp without having to power off the instrument.
After replacement, wait 30 minutes for the photometer lamp to stabilize and perform a cell blank measurement before you resume routine operation. This is necessary to compensate for a possible change in light intensity.
(14) Parameter Read/Write Control unit: The settings of the system parameters are read from or written on a storage medium (DVD). The system parameters can only be restored to the same cobas 8000 instrument.
u
For more information, see:
To save system parameters on a storage medium (p. 532)
To restore system parameters to the system (p. 534)
(15) Test Count Write Core: Test count is written on a storage medium (DVD).
Note: Insert the storage medium into the drive before you execute (15) Test Count
Write.
(16) QC Timer Reset Core: Resets the control interval timer.
For example, the control interval timer is set to 10 hours. When 5 hours are left, you can reset the timer to 10 hours.
Roche Diagnostics
Operator’s Manual · 4.2.1
613
20 General maintenance
List of maintenance items cobas® 8000 modular analyzer series
(17) System Wash c 701 / c 702: All reaction cells and reagent probes are washed with NAOHD ( D1 ) from a reagent pack. The sample probes are washed with SmpCln 1 (basic wash) from the 20 mL container (approx. 300 μ L).
e 602: Combination of maintenance items (19) Reagent Probe Wash, (20) Bead
Mixer Rinse, and (29) Pre-wash Sipper Rinse. This combination is performed as many times as specified.
(18) Sample Probe Wash ISE, c 701 / c 702, c 502: The sample probes are washed with SmpCln 1 (basic wash) from the 20 mL container (approx. 300 μ L). Use this item in case of a clogged probe.
(19) Reagent Probe Wash e 602: Both the inside and outside of the reagent pipetter probe is washed as many times as specified.
(20) Bead Mixer Rinse e 602: The microbead mixer is rinsed as many times as specified.
(21) e602 Reagent Wash e 602: The auxiliary reagent flow paths and the reservoirs for both ProCell and
CleanCell are rinsed. That is, remaining liquid is aspirated from the reservoirs (by one of the two sippers or by both sippers, depending on their availability) and discharged to the rinse stations. Then, the auxiliary reagent flow paths and reservoirs are filled with deionized water.
The sippers aspirate liquid in the reservoirs and discharge it to the rinse stations as many times as necessary for draining all reservoirs.
Afterwards (8) Reagent Prime and (31) Finalization should be performed.
(22) Pipetter Air Purge e 602: Sample pipetter and reagent pipetter flow paths are purged of air as many times as specified.
(23) Sipper Air Purge e 602: Sipper flow paths are purged of air as many times as specified.
(24) MC Preparation e 602: Measuring cells are conditioned as many times as specified.
(25) MC Exchange e 602: Sipper flow paths are rinsed with deionized water as many times as specified and then emptied to be prepared for a measuring cell exchange.
(26) Liquid Flow Cleaning e 602: Sipper flow paths are washed with SysClean. Liquid flow path cleaning must be performed at least once every two weeks or after 2500 to 3000 determinations per measuring channel.
(27) Inventory Update e 602: The remaining amount of ProbeWash solution and the number of magazines and waste magazines are updated in the instrument software. The number of
AssayCups and AssayTips is verified in the current magazine.
If the number is lower than expected by the software, the AssayCups or AssayTips are discarded from the current magazine and a full magazine will be lifted to the top. A reagent registration can be performed additionally.
(28) ISE System Wash ISE: The reagent flow path is washed with 200 mL SysClean solution (10 mL SysClean diluted 1:20 with deionized water), which must be prepared in a separate container.
u
For more information, see:
Power Off Pipe function (p. 601)
To prepare the green wash rack (p. 648)
(29) Pre-wash Sipper Rinse e 602: Pre-wash sipper is rinsed as many times as specified.
(30) Pre-wash Sipper Air Purge e 602: Pre-wash sipper flow paths are purged of air.
Roche Diagnostics
614 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
List of maintenance items
(31) Finalization e 602: Finalization routine is carried out on sample pipetter, reagent pipetter, sipper, detection unit, and auxiliary reagent unit. The system is primed with water and the measuring cell is filled with ProCell.
u
For more information on the procedure, see
(32) Empty PC/CC Reservoir e 602: ProCell and CleanCell reservoirs are drained.
(33) Initial Bead Mixing e 602: Microbeads are mixed for 15 seconds in all except the empty reagent packs.
(34) Reagent Capping e 602: All open cobas e packs are closed.
(35) AssayCup Discarding e 602: All AssayCups are removed from the incubator and discarded.
(36) System Air Purge (e602) e 602: The following maintenance functions are performed simultaneously: o
(22) Pipetter Air Purge o
(23) Sipper Air Purge o
(30) Pre-wash Sipper Air Purge.
(37) System Prime (e602) e 602: ProCell, CleanCell, and the Pre-wash lines are primed simultaneously.
Roche Diagnostics
Operator’s Manual · 4.2.1
615
20 General maintenance
List of maintenance checks
List of maintenance checks
cobas® 8000 modular analyzer series
This section contains a brief description of all maintenance checks listed under
Utility > Maintenance > 2 Check .
(1) Disk Check Control unit: Files are checked on hard disk and a directory listing is printed out. If a malfunction occurs, the system issues an alarm. Choose Print > History to view the results of the Disk Check report. The instrument software version is listed at the end of the report.
(2) ISE Check ISE module: The output of ISE electrodes (Na, K, Cl, and REF electrodes) is measured with ISE IS (10 cycles) and a listing of the measured voltages is printed out. u
See To perform an ISE Check and calibrate the ISE units (p. 668).
(3) Mechanism Check All modules: Performs a functional check of the mechanical parts of the selected module(s).
Clear the SU check box to select particular modules and to exclude the rack conveyor lines from this test. Additionally, the Limit Cycles and Unlimited options are available in this case. o
Limit Cycles : Enter a number of cycles in the text box. The mechanism check ends automatically when the cycles are completed.
o
Unlimited : The mechanism check must be stopped by choosing the Stop button.
Choose Stop to end this maintenance check. Or: Choose S.Stop
to end this maintenance check and to move all racks to the unloading area. Perform this check as needed after replacing the sample or reagent probe and after replacing the nozzle tips on the cell rinse nozzles.
u
See:
To perform a Mechanism Check (p. 686)(ISE)
To perform a Mechanism Check (p. 755) (
c 701, c 502)
(4) Probe Check c 701 / c 702, c 502: Puts the module in Probe Check mode. In this mode, the selected sample probe, reagent probe, or cell rinse units can be moved to designated positions by means of the F1 push button behind the front door of the c 701 / c 702 module.
On the c 502 module, this function must be performed with closed top cover due to the Interlock function. Consequently, it is not possible to sight check the alignment of the probe.
To terminate Probe Check mode, select Cancel Maintenance from the Overview menu.
u
See To check the horizontal alignment of a probe (p. 752).
(5) ISE Probe Check ISE module: Puts the module in Probe Check mode. In this mode, the sample probe can be moved to designated positions by means of the Next button. As this function must be performed with closed cover, it is not possible to sight check the alignment of the probe.
To terminate ISE Probe Check mode, choose Stop in the Confirmation window.
u
See To check the horizontal alignment of a probe (p. 684).
(6) Sample Barcode Reader Check Core, ISE, c 701 / c 702, c 502, e 602: Checks the sample barcode readers on the modules by scanning a rack with barcoded samples. After choosing Stop , the data are printed out for verification.
Roche Diagnostics
616 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
List of maintenance checks
To check the function of the barcode reader, make sure barcoded samples are loaded before starting the check.
Choose Print > History to view the results.
(7) Reagent ID Reader Check The reagent barcode reader or RFID reader is checked according to the entered number of cycles. Choose Stop or Cancel Maintenance to printout the data for verification. Choose Print > History to view the results.
c 701: The performance of the RFID readers is checked.
c 702 / c 502: After starting the (7) Reagent ID Reader Check a reagent pack must be inserted in the loading port. The RFID information ( c 502: barcode information) is read from the reagent pack label according to the input number of cycles. Finally the reagent pack is ejected and can be removed.
e 602: The barcodes of the loaded cobas e packs are scanned.
(8) R. Pack Loading Check c 702: The gripper and other reagent pack loading components are checked according to the input number of cycles (minimum: 5 cycles).
c 502: The reagent pack loading mechanism is checked as well as the gripper and piercer movement. The check is performed according to the input number of cycles
(minimum: 5 cycles).
(9) Cuvette Mixing c 701 / c 702, c 502: Performs a functional check (10 cycles) on the ultrasonic mixers
– optionally with cell wash.
The reagent probe pipettes deionized water into the corresponding cuvette for R1, R2 and R3 mixers. Then the cuvette turns to the mixing position and ultrasonic mixing is executed. On c 701 / c 702 modules, the proper operation of the corresponding mixer can be checked visually—the water in the cuvette is vibrating when the mixer is operating. On c 502 modules, the visual check is not necessary.
u
See To check the intensity of the ultrasonic output (p. 731).
(10) Reagent Short Sensor Check e 602: The sensors in the lines of the PreClean, ProCell, and CleanCell bottles are checked.
(11) Sample Pipetting Check e 602 : The movement of the sample pipetter and its liquid level detection function are checked.
(12) Reagent Pipetting Check e 602 : The movement of the reagent pipetters is checked.
(13) Cap Opener Check e 602 : The movement of the cap opener is checked.
(14) Bead Mixer Check e 602 : The movement of the microbead mixer is checked.
(15) Gripper Check e 602 : The movement of the gripper and its AssayTip / AssayCup handling function are checked.
(16) Magazine Exchange Check e 602 : The movement of the magazine exchange is checked.
(17) Sipper Check e 602 : The movement of the sippers and their liquid level detection function is checked.
(18) Pre-wash Probe Check e 602 : The movement and function of the Pre-wash probe is checked. The Pre-wash probe aspirates and discharges PreClean during this procedure.
Roche Diagnostics
Operator’s Manual · 4.2.1
617
20 General maintenance
List of maintenance checks cobas® 8000 modular analyzer series
(19) Pre-wash Gripper Check e 602 : The movement sequence and the AssayCup handling function of the Pre-wash gripper are checked.
Before you start this procedure, make sure to place AssayCups on the following positions: o
Pre-wash Gripper position on the incubator o
Vortex mixer position o
First position in the Pre-wash station
(25) Urgent Information The data manager receives information from Roche Diagnostics via cobas link once per day automatically, such as new and updated application, calibrator and control parameters. If new or updated parameters are available, this will be shown in the
Overview > Parameter Download window. With this function you can manually force the data manager to synchronize parameters with cobas link. This function can only be performed in Standby.
(26) Essential Information Upload This function saves the complete database including sample, calibrator and control data as a backup file to the data manager. The last 3 backups will be stored, the oldest backup will be overwritten with the newest backup. Hence the last 3 backups are available to restore to the instrument if required (e.g., after a hard disk failure). This function can only be performed in Standby and only within a maintenance pipe.
It is recommended performing this maintenance item regularly. Please contact either your Roche service representative or technical support to include Essential
Information Upload in a maintenance pipe.
u
For more information, see:
Defining and editing maintenance pipes (p. 596)
Recommended maintenance pipes (p. 603)
(27) Database Backup This function creates a GetLog file of the instrument database and transfers it to the data manager. Select this function in order to investigate instrument problems or failures. This function can only be performed in Standby.
The GetLog file must be exported to Roche by creating an Issue Report from the data manager. Please contact your Roche service representative.
(50) Program Update This function allows to update the instrument software via the data manager.
Language versions (including Online Help and alarm database) of the software and maintenance videos for the Online Help can also be installed using this function.
Roche Diagnostics
618 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Combined maintenance schedules (all modules)
Combined maintenance schedules (all modules)
CAUTION
WARNING
This section provides an overview of the maintenance actions required for proper instrument care. The information is sorted according to the frequency with which the actions must be performed.
Incorrect results or damage to the instrument due to non-compliance of maintenance intervals
The intervals for maintenance and checkup recommended in this document are independent of the system operation time unless otherwise noted (e.g., maintenance actions which are based on test count or time). If the intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
r Observe the maintenance intervals stated in this document.
u
The total power-on time is displayed on the Cumulative Operation List report. To view this report, choose Print > History > Cumulative Operation List .
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in personal injury and infection. r Whenever possible, keep all covers of the modules closed.
r Make sure that the instrument is in Standby before executing a maintenance item or check.
r If a check or maintenance action requires open covers (e.g., cleaning pipetter probes), always make sure to switch off the instrument (or to use the appropriate instrument status).
Symbols used in the maintenance schedules
– l
This action is not performed or not available for this module.
This action is performed.
Roche Diagnostics
Operator’s Manual · 4.2.1
619
20 General maintenance
Combined maintenance schedules (all modules)
Daily maintenance schedules
cobas® 8000 modular analyzer series
Instrument inspection – either before start-up or after power-off
Procedure Module
Instrument inspection, including:
Check for any leakages
Unload all racks from the unloading area l l l
Core ISE c 701 c 702 l l l l
– –
Turn on main water supply before shift.
Turn off if instrument is switched off and unused for more than 8 hours.
– – –
– – l
Load auxiliary reagents for the Daily pipe ( Power Up Pipe function)
Table 20-9 Instrument inspection c 502 e 602
–
– l l l
–
– l l
–
Daily maintenance – at start up
(Daily pipe)
Procedure
Table 20-10
ALL
ALL , 20 cycles
Module
Core ISE c 701 c 702
–
–
–
– l
– l
–
Daily maintenance – at start up (Daily pipe) l l
– l c 502 e 602 l l
– l
–
–
–
–
Items that can be performed in a daily Power Off pipe
Procedure
Table 20-11
Module
Core ISE c 701 c 702
– l
– l
Items that can be performed in a daily Power Off pipe c 502 e 602
– l
–
Daily manual maintenance We recommend performing these actions after the working shift.
Procedure
Empty the concentrated waste container
Table 20-12 Daily manual maintenance
–
Module
Core ISE c 701 c 702
– l
– l
–
–
– l l
–
–
– l
– – c 502 e 602
– l
–
– l
–
–
–
–
– l
Roche Diagnostics
620 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Combined maintenance schedules (all modules)
Maintenance schedules – weekly and longer intervals
Weekly
Procedure
Module
CU ISE c 701 c 702 c 502 e 602
– l
– l
– l
– l
–
– l
– – l l l
–
p. 702 Washing the reaction parts, including
item (4) Cell Blank Measurement
Cleaning the discharge chute for reagent caps
Checking the reagent pack gripper
–
–
–
–
Cleaning ProCell/CleanCell nozzles and replace reservoirs
Cleaning the mixing and separation stations
–
–
–
–
–
–
Table 20-13
–
–
–
–
Recommended weekly maintenance l
–
–
–
–
–
– l l l
–
–
–
– l
–
–
–
–
–
–
–
–
– l l l l
Every two weeks
Procedure
Table 20-14
Module
CU ISE c 701 c 702 c 502 e 602
– – –
Recommended maintenance – every two weeks
– – l
Monthly
Procedure Module
Checking the ISE dilution vessel
Cleaning the ISE reagent aspiration filters
Replacing reaction cells and cleaning incubator bath
Cleaning the detergent aspiration filters
Cleaning the filters behind front doors
CU ISE c 701 c 702 c 502 e 602 l
–
–
–
–
–
– l
– l
–
–
–
– l l l l l
–
– l l l l
–
– l l l l
–
–
–
–
–
Table 20-15 Recommended monthly maintenance
Every two months
Procedure
Replacing the Na, K and Cl electrodes
Table 20-16
Module
CU ISE c 701 c 702 c 502 e 602
– l
– –
Recommended maintenance – every two months
– –
Roche Diagnostics
Operator’s Manual · 4.2.1
621
20 General maintenance
Combined maintenance schedules (all modules) cobas® 8000 modular analyzer series
Quarterly
Procedure
Washing the ISE reagent flow paths
Replacing the ISE pinch valve tubing
Cleaning the ultrasonic mixers
Cleaning the filter of the solenoid valve
Replacing the pinch valve tubings
Table 20-17
Module
CU ISE c 701 c 702 c 502 e 602
–
–
–
–
– l
– l
–
– l
– l
– –
–
– l l
–
–
– l
–
–
–
–
–
– l
Recommended quarterly maintenance
Roche Diagnostics
622
Every six months
Procedure
Replacing the ISE reference electrode
Cleaning the water inlet filter
Table 20-18
Module
CU ISE c 701 c 702 c 502 e 602 l
–
–
– l
–
– l l
– l l l
– l l l
– l l l
–
– l
Recommended maintenance – every six months
As needed
Procedure
Draining the tank of degasser and water trap
Cleaning the concentrated waste container
Cleaning the ISE dilution vessel
Replacing the pipetter probes – elimination of clogging
–
–
–
–
Replacing nozzle tips on cell rinse nozzles –
l
– – l
– l
–
–
– l
– l l
Cleaning the waste box for reagent caps
Cleaning the reagent pack gripper
Cleaning ProCell/CleanCell stand and aspiration tubes
Cleaning the reagent disk and compartment
Cleaning the solid waste compartment
–
–
–
–
–
Finalization: Reagent prime, finalization
and reagent capping must be performed together if an analysis was interrupted.
–
Extended power OFF and ON procedures
–
Table 20-19 Maintenance – as needed
Module
CU ISE c 701 c 702 c 502 e 602 l
– l l
– l
–
–
–
–
–
–
– l l l
–
– l
–
–
–
–
–
–
–
–
– l l l l
–
– l l l
–
–
–
–
–
–
– l l l l
–
– l
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– l
–
– l l l l l
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Combined maintenance schedules (all modules) u
For detailed maintenance schedules of each module, see:
Maintenance schedule for the core unit (p. 633)
Maintenance schedule for the cobas ISE module (p. 645)
Maintenance schedule for photometric modules (p. 691)
Maintenance schedule for the cobas e 602 module (p. 763)
Scheduling periodic maintenance tasks
We recommend letting the instrument’s software remind you of all periodic maintenance tasks. You can do this by configuring maintenance types (from Utility
> System > Maintenance Settings ). Within a maintenance type, you can assign maintenance intervals ( Period check box) and warning levels to each maintenance item and maintenance pipe.
u
For more information on scheduling maintenance tasks, see
Maintenance types—scheduling and tracking maintenance items (p. 588).
Roche Diagnostics
Operator’s Manual · 4.2.1
623
20 General maintenance
Background and parallel maintenance
Background and parallel maintenance
cobas® 8000 modular analyzer series
Background maintenance
(module masking)
Background maintenance is used to perform maintenance functions on one or more modules while the instrument is still in Operation mode.
A module must be masked to perform background maintenance on it. This means, the module is unavailable for operation.
u
For more information, see Performing background maintenance (module masking)
Parallel maintenance You may use parallel maintenance to perform different maintenance items on different modules while the system is in Standby mode.
u
For more information, see Performing parallel maintenance (p. 628).
Commonalities of background and parallel maintenance
Pipe functions cannot be performed as background or parallel maintenance; you must perform all maintenance items individually.
The tables on the following pages indicate the instrument status in which the maintenance items and checks can be performed.
Abbreviations used in the following tables: l
SB
B
P
This item can be performed
Standby mode
Background maintenance (module is masked)
Parallel maintenance on different modules (system in Standby)
Maintenance Item ISE
SB B l l
l l l l l l
Table 20-20 l
Available operation modes for maintenance items
P l
Roche Diagnostics
624 c 701 / c 702
SB l
B l
P l l l l l l l l l l l (1) l l (2) l l l (1) l l (2) l l l l l l l l l l (2) l l l l l (2) l l l l l l l (1) l (1) l (1) l (1) l l (1) l (1) l (1) l (1) l l l l l l
SB l c 502
B l
P l l l l l l l
SB l e 602
B l
P l l l l l l l l l l
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Background and parallel maintenance
Maintenance Item ISE
SB B P
(30) Pre-wash Sipper Air Purge
l
Table 20-20 Available operation modes for maintenance items c 701 / c 702
SB B P SB c 502
B P SB l l l l l l l l l l l l l l l l l l e 602 l l l l
B l l l l l l l l l l l l l l l l l l
P l l l l l l l l l l l l l l
(1) This item cannot be performed on the c 701 / c 702 module closest to the ISE module while the ISE module is operating or performing (2) ISE Check.
(2) Except for the sample probes
Maintenance Check ISE
SB B P c 701 / c 702
SB B P
(6) Sample Barcode Reader Check
l l l l (1) l l (1) l
(10) Reagent Short Sensor Check
Table 20-21 Available operation modes for maintenance checks l l l l l (2) l l l l l (2) l l l l l (2) l
Roche Diagnostics
Operator’s Manual · 4.2.1
SB c 502
B P l l l l l l l l l l l l l l l l
SB e 602
B P l l l l l l l l l l l l l l l l l l l l l l
625 l l l l l l l l
20 General maintenance
Background and parallel maintenance cobas® 8000 modular analyzer series
Maintenance Check ISE
SB B P
(26) Essential Information Upload
Table 20-21 Available operation modes for maintenance checks c 701 / c 702
SB B P SB c 502
B P SB l l
(1) This item cannot be performed while the c 701 / c 702 module closest to the ISE module is performing (5) Incubation Water Exchange,
(10) Incubator Bath Cleaning, (11) Manual Cleaning, (12) Change Reaction Cell, or (13) Change Photometer Lamp.
(2) Not available on c 701 modules. Only available if the MSB and c 702 module are masked. e 602
B l l
P l l
Performing background maintenance (module masking)
Use the following procedure to perform maintenance on one analytical module while the system is operating. Masking means to make this module unavailable for operation.
q Module masking
In general, each module can be masked and unmasked separately. The system can be in
Standby or in an operational status, but masking is also possible during most operational and maintenance statuses.
A module can be masked without the module sample buffer (MSB). Then the MSB can operate while the module is masked.
However, water and vacuum are supplied to the ISE module by the first c 701 / c 702 module of the system. Therefore, their operation or maintenance is limited by the supply situation of water and vacuum. For this reason, a number of maintenance items cannot be performed on the first analytical module while the ISE module is operating or performing (2) ISE Check.
The following maintenance items are subject to this limitation: o
(5) Incubation Water Exchange o
(10) Incubator Bath Cleaning o
(11) Manual Cleaning o
(12) Change Reaction Cell o
(13) Change Photometer Lamp q Mask the ISE module together with the first analytical module if you want to perform these maintenance items during background or parallel maintenance.
The following table shows module statuses in which the modules can be masked independently.
Status of ISE module
Status of first c 701 / c 702 module
Accepted
Limited (1)
Table 20-22
Module mask
Operation,
ISE check
Operation
Module mask
Independent masking of the ISE module and the first module
Roche Diagnostics
626 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Background and parallel maintenance
(1) Neither Operation nor (2) ISE Check can be executed on the ISE module when one of the
5 maintenance items mentioned above is executed on the first module.
q Module unmasking
To unmask a module, it must be in Standby. If the system is in operation, the module automatically joins the status of the system after unmasking.
p To perform background maintenance
1
Choose Start (global button) to display the Start window.
2
Choose Masking > Module Masking .
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 20-15 Module Masking window
3 Choose the modules to be masked. The module buttons toggle between Module
Mask , Service Mask , and Unmask . When a module is masked, it appears crossed out on the display.
4 Choose Execute to allow the changes to take effect.
5 Exit the Masking window and the Start window.
6 Choose the Overview menu to check the status of the module.
Prior to masking, the module completes any samples assigned to it. The masking process can take a couple of minutes depending on the number of samples and the tests selected. During the masking process, a dotted gray cross is displayed on the module button and the module status can not be changed.
Then the status of the module changes to Standby.
7 You may now perform any of the maintenance procedures listed in the background maintenance table.
u
See
Background and parallel maintenance (p. 624).
s
627
20 General maintenance
Background and parallel maintenance
Performing parallel maintenance
cobas® 8000 modular analyzer series
You may use parallel maintenance to perform different maintenance items on different modules while the system is in Standby mode.
Pipe functions cannot be performed as parallel maintenance; you must perform all maintenance items individually.
For example, you can select maintenance item (8) Reagent Prime on one module and maintenance item (6) Air Purge on another module.
u
See Background and parallel maintenance (p. 624).
If you need to stop a maintenance procedure while the other modules are in operation, use the following steps.
Stopping background and parallel maintenance
Use the following procedure to stop background or parallel maintenance. However, not all maintenance items can be stopped once started.
q Do not choose Stop (global button) to end background maintenance. This would stop all functions on all modules.
p To stop background or parallel maintenance
1
Choose Overview .
2
Select the button of the module performing the maintenance function you want to stop. The Module window is displayed.
3
Select Cancel Maintenance . The corresponding window is displayed.
4
Confirm with OK to stop the action.
The module returns to Standby.
q Before unmasking a module, check that it is Standby. Then the module will automatically return to operation if the system is in operation status.
5
Unmask the module if it was masked.
s
Roche Diagnostics
628 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 20 General maintenance
Periodic replacement of parts
Periodic replacement of parts
CAUTION
CAUTION
Some parts require periodic replacement for preventive maintenance. Replace these parts regularly and in accordance with your workload and the recommendations given in this document.
Injury when the system is restarted accidentally
If the instrument is restarted accidentally by a third person during replacement of parts, this may cause injury or damage to the system. r Before replacing any parts, be sure to power off the instrument or the module.
u
See
To power off a specific module (p. 591).
Incorrect results due to improper spare parts
For proper instrument function, use only original spare parts provided by Roche. r The necessary spare parts are listed in the description of the corresponding maintenance action.
r To order spare parts, please contact your Roche representative.
r When replacing parts (e.g., sample probe or nozzle tips), check their part numbers.
ISE module
Item As needed 2 months 3 months 6 months
ISE measuring electrodes
(Na
+
, K
+
, Cl
-
)
ISE pinch valve tubing l (1)
ISE reference electrode
ISE sample probe
Table 20-23 l
Periodic replacement of parts for the ISE module
l
l
(1) Replace the ISE measuring electrodes after two months or after measuring 9000 samples.
Photometric modules
Item As needed Monthly 3 months 6 months
Reaction cells l
Photometer lamp l (1)
Nozzle tips of cell rinse unit
Sample and reagent probes
Table 20-24 l l
Periodic replacement of parts for c 701 / c 702 / c 502 modules
(1) Replace the lamp if the photometer check value exceeds 14 000 or when used for more than 750 hours of power-on time. Check the power-on time at the top of the Maintenance Report .
e 602 module
Item As needed Weekly 3 months 6 months
Pinch valve tubings
Table 20-25 l (1)
Periodic replacement of parts for the e 602 module
(1) Replace the pinch valve tubings after three months or after measuring 25,000 tests per measuring channel.
Roche Diagnostics
Operator’s Manual · 4.2.1
629
20 General maintenance
List of maintenance videos
List of maintenance videos
cobas® 8000 modular analyzer series
This list provides an overview about the available video clips for maintenance actions in the Online Help system of the cobas 8000 analyzer. q o The video clips are only available if the instrument is in Standby.
o These video clips are intended to complement the textual description of the maintenance actions, but they cannot replace the description.
Video clips are available for the following maintenance actions:
Maintenance action
Replacing the Na, K and Cl electrodes
Replacing the ISE reference electrode
Module
Core ISE l
–
–
–
– l l
– c 701 c 702 l
–
– l c 502 e 602 l
Replacing reaction cells and cleaning incubator bath
–
–
Replacing nozzle tips on cell rinse nozzles
Replacing the pipetter probes – elimination of clogging
Cleaning ProCell/CleanCell nozzles and replace reservoirs
Cleaning the mixing and separation stations
–
–
–
–
Replacing the pinch valve tubings
Cleaning the reagent disk and compartment
Cleaning the solid waste compartment
Table 20-26 Maintenance actions with videos
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– l l l l
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
(1) The video shows the c 701 module, but it also applies accordingly to the c 502 module.
–
–
–
–
–
–
– l (1) l
–
–
–
–
–
–
– l l l l l l l l l
Roche Diagnostics
630 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Maintenance of the core unit
21 Maintenance of the core unit
21
This chapter describes maintenance actions required for correct and efficient running of the core unit.
The schedule contains all periodic maintenance actions (daily, weekly, quarterly, …) as well as maintenance actions that are performed as needed.
In this chapter
Chapter
21
Roche Diagnostics
Operator’s Manual · 4.2.1
631
21 Maintenance of the core unit
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
632 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 21 Maintenance of the core unit
Maintenance schedule for the core unit
Maintenance schedule for the core unit
This maintenance schedule lists all maintenance actions that must be performed on the core unit.
Procedure
Monthly
Every six months
As needed
Table 21-1
Draining the tank of degasser and water trap
Maintenance schedule – core unit
Instrument status
PO
PO
PO
PO/SB
Instrument status (mode)
CAUTION
PO
SB
Power Off (or powered off on Utility > System Configuration > Module Settings ), see:
To power off a specific module (p. 591).
Standby mode
Incorrect results or damage to the instrument due to non-compliance of maintenance intervals
The intervals for maintenance and checkup recommended in this document are independent of the system operation time unless otherwise noted (e.g., maintenance actions which are based on test count or time). If the intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
r Observe the maintenance intervals stated in this document.
u
For information about intervals based on test count or time, see:
Periodic replacement of parts (p. 629).
u
For information on scheduling maintenance tasks, see:
u
For more information about the maintenance actions required in certain intervals, see:
Every six months maintenance (p. 638)
As needed maintenance (p. 640)
Roche Diagnostics
Operator’s Manual · 4.2.1
633
21 Maintenance of the core unit
Monthly maintenance
Monthly maintenance
cobas® 8000 modular analyzer series
This section describes the maintenance action that must be performed at least once a month on the core unit.
Cleaning the water tanks
Contamination inside the black water tanks will result in contamination of the entire flow path and adversely affect all measurements. Check each water tank at least once a month and clean it if necessary.
Operator time approximately 8 minutes per module sample buffer
Materials required m
0.5 % sodium hypochlorite solution m
Deionized water m
Lint-free gauze pads m
Paper towels m
Brush
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Malfunction due to spilled liquid (p. 582)
p To disconnect a water tank
1
Power off the complete instrument or the individual module that uses the water tank.
u
See:
To power off the instrument (p. 293)
To power off a specific module (p. 591)
Roche Diagnostics
634 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
2 Turn off external water supply.
21 Maintenance of the core unit
Monthly maintenance
A
A Water tank
Figure 21-1 Close the tap at the water tank
3
Locate the water tank (
) at the rear of each module sample buffer.
4
Close the tap at the outlet of the water tank.
A
A Unlocked position
Figure 21-2 Disconnecting the joint
5 Place paper towels under the joint to absorb spilled water.
6 Turn the ring to the unlocked position (
Roche Diagnostics
Operator’s Manual · 4.2.1
635
21 Maintenance of the core unit
Monthly maintenance
7 Separate the joint.
A cobas® 8000 modular analyzer series
Roche Diagnostics
636
A Liquid level sensor assembly
Figure 21-3 Cleaning the liquid level sensor assembly
8 Lift the liquid level sensor assembly (
A ) from the tank and place the assembly on a
paper towel.
9 Wipe the liquid level sensor assembly with gauze pads moistened with deionized water.
10 Empty the water from the tank. The water must be clear. If it is not, clean the tank thoroughly.
u
See:
To thoroughly clean the water tank (p. 636)
11 If the water is clear, only rinse the tank with deionized water three times.
Continue to reconnect the water tank.
u
See:
To reconnect the water tank (p. 637)
s p To thoroughly clean the water tank
1 Rinse the tank thoroughly with 0.5 % sodium hypochlorite solution. For thorough cleaning use a brush to clean the tank inside. Then rinse with tap water to eliminate the sodium hypochlorite solution.
2 Rinse the tank thoroughly with deionized water three times.
Continue to reconnect the water tank.
u
See:
To reconnect the water tank (p. 637)
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 21 Maintenance of the core unit
Monthly maintenance p To reconnect the water tank
1 Fill the tank at least 1/3 with deionized water.
2 Return the liquid level sensor assembly to the tank.
CAUTION
A
A Locking the joint
Figure 21-4 Reconnecting the joint
3
Reconnect and lock the joint.
Slip hazard and damages due to leaking water
If the joint of the water tank is not connected properly, water may leak. r Ensure that all joints are connected properly.
r Observe in particular the following safety label on the instrument:
4
Open the tap.
5
Turn on external water supply.
6
Power on the instrument or module again, or continue performing other maintenance tasks.
u
See:
To power on a specific module (p. 591)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
637
21 Maintenance of the core unit
Every six months maintenance
Every six months maintenance
cobas® 8000 modular analyzer series
This section describes the maintenance action that must be performed at least once every six months on the core unit.
Cleaning the cooling fans
Clean the cooling fans at the rear of each module to remove dust and dirt.
Operator time approximately 1 minute per fan
Materials required m
Vacuum cleaner m
Brush
CAUTION p To clean the cooling fans
1 Power off the complete instrument or the individual module to which the cooling fan belongs.
Personal injury by touching the fan
There is a grill to protect the operator from coming into contact with the moving fan.
Do not insert your fingers into the openings of the ventilation grill. If you clean the fan during power on, you may suffer injuries.
r Therefore power off the instrument before cleaning.
A B C
Roche Diagnostics
638
A Cooling fan of module sample buffer
B Cooling fan of ISE module
Figure 21-5
C Cooling fan of core unit
Examples of cooling fans to be cleaned
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 21 Maintenance of the core unit
Every six months maintenance q
2 Vacuum or brush dust, dirt, and other debris from all cooling fans at the rear of the instrument.
The module sample buffer of the c 702 module has three cooling fans that must be cleaned.
3 Power on the instrument or module again, or continue performing other maintenance tasks.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
639
21 Maintenance of the core unit
As needed maintenance
As needed maintenance
cobas® 8000 modular analyzer series
This section describes the maintenance actions for the core unit that must be performed as needed and are not subject to a regular schedule.
u
This section discusses the following maintenance actions:
Draining the tank of degasser and water trap (p. 640)
Cleaning instrument surfaces (p. 641)
Draining the tank of degasser and water trap
A degasser and a water trap are provided in the module sample buffer of each c 701 / c 702 and e 602 module. If the connected tank is filled with water, it may affect the performance of the degasser.
Drain the water when an alarm is issued.
Operator time approximately 1:30 minutes per module sample buffer
Materials required m
Beaker p To drain the tank of the degasser and water trap (c 701 / c 702 / e 602)
1
Power off the complete instrument or the individual module to which the tank belongs.
Roche Diagnostics
640
Figure 21-6 Disconnecting the hose of the water trap tank
2 Place a 500 mL beaker (or other appropriate container) beneath the outlet of the tank tube.
3 Turn the outlet cap counterclockwise and disconnect it.
4 Drain the water into the beaker.
5 Reconnect the outlet cap and tighten it securely.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 21 Maintenance of the core unit
As needed maintenance
6 Power on the instrument or module again, or continue performing other maintenance tasks.
s
Cleaning instrument surfaces
Spills on the instrument surface could be biohazardous and damage the surface.
Clean up all spills immediately. Use this procedure to ensure that surfaces on all modules are clean.
Materials required m
Disposable cloth or paper towels m
Laboratory disinfectant (no bleach)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
NOTICE Damage to instrument surfaces r Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
p To clean instrument surfaces
1
Power off the complete instrument.
Or: Ensure the instrument is in Standby.
2
Clean the module surfaces using a cloth or paper towel moistened with disinfectant.
Clean up all spills immediately. Ensure that all surfaces are clean.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
641
21 Maintenance of the core unit
As needed maintenance cobas® 8000 modular analyzer series
Roche Diagnostics
642 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
22 Maintenance of cobas ISE module
Maintenance of cobas ISE module
22
Roche Diagnostics
Operator’s Manual · 4.2.1
This chapter describes the maintenance actions required for correct and efficient running of the ISE module. The schedule contains all required periodic maintenance actions (daily, weekly, monthly…).
In this chapter
Chapter
22
Washing with green rack at the end of analysis each day ................................ 649
Washing with green rack during continuous operation .................................. 650
Emptying and cleaning the concentrated waste container .................................... 655
Replacing the ISE sample probe – elimination of clogging ................................... 680
643
22 Maintenance of cobas ISE module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
644 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Maintenance schedule for the cobas ISE module
Maintenance schedule for the cobas ISE module
The following table lists all maintenance actions required for the ISE module:
Daily
Procedure
Weekly
Monthly
Every two months
Quarterly
Emptying and cleaning the concentrated waste container
Checking the ISE dilution vessel
Cleaning the ISE reagent aspiration filters
Replacing the Na, K and Cl electrodes
(2)
Washing the ISE reagent flow paths
Every six months
As needed
Table 22-1
Replacing the ISE pinch valve tubing
Replacing the ISE reference electrode
Cleaning the ISE dilution vessel
Replacing the ISE sample probe – elimination of clogging
Maintenance schedule – ISE module
(1) From any operational status, such as Standby or Rack Reception mode, or within a maintenance pipe.
(2) Replace the ISE measuring electrodes after two months or after measuring 9000 samples.
Instrument status
–
(1)
SB/MM/PO
SB/MM/PO
SB/MM/PO
MC/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB
SB/MM/PO
SB/MM/PO
SB/MM/PO
PO
SB/MM/PO
Instrument status (mode)
CAUTION
PO
SB
MM
MC
Power Off (or module powered off on Utility > System Configuration > Module
Settings )
Standby mode
Module Masked ( Start > Masking > Module Masking ), puts single modules in a status equal to Standby
Manual Cleaning mode u
For more information, see: Instrument statuses for maintenance (p. 590).
Incorrect results or damage to the instrument due to non-compliance of maintenance intervals
The intervals for maintenance and checkup recommended in this document are independent of the system operation time unless otherwise noted (e.g., maintenance actions which are based on test count or time). If the intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
r Observe the maintenance intervals stated in this document.
u
For information about intervals based on test count or time, see:
Periodic replacement of parts (p. 629).
u
For information on scheduling maintenance tasks, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
645
22 Maintenance of cobas ISE module
Daily maintenance
Daily maintenance
cobas® 8000 modular analyzer series
This section describes the maintenance actions for the ISE module that must be performed every day.
Contamination of flow paths or the pipetter probe may cause incorrect measurement results or clogging. Therefore, make sure to regularly perform the stated maintenance procedures.
u
This section discusses the following maintenance actions:
Processing green wash rack (p. 646)
Cleaning the ISE sample probe (p. 651)
Cleaning the ISE drain ports (p. 653)
Emptying and cleaning the concentrated waste container (p. 655)
Processing green wash rack
Washing with a green wash rack must be processed once every 24 hours.
The cobas 8000 instrument provides two options to perform this maintenance task: o
Normally the green wash rack is processed at the end of analysis each day: u
See
Washing with green rack at the end of analysis each day (p. 649)
o
If your instrument is operated continuously for more than 8 hours of operation per day, the green wash rack can also be processed during operation: u
See
Washing with green rack during continuous operation (p. 650)
q This is a combined maintenance action for the ISE module and all photometric modules .
The inner wall of the sample probe and the waste solution flow path is cleaned as well as the ISE sample flow path, the ISE dilution vessel, and the electrodes; after cleaning, the electrodes are reconditioned with Activator.
Operator time approximately 3 minutes, plus 2 minutes for ISE calibration
System time approximately 21 minutes, plus 8 minutes for ISE calibration
Materials required m
Green rack (wash rack), incl. sample tubes or cups with: m
SmpCln 1 (only required for photometric modules) m
SysClean (ISE cleaning solution) m
Activator (ISE conditioning solution) m
NAOHD ( D1 ) reagent packs on both reagent disks (only required for c 701 / c 702 modules): approximately 7.6 mL m
ISE reagents (for 15 wash cycles on 2 ISE measuring units): m
Internal standard (ISE IS): approximately 54 mL m
Diluent (ISE DIL): approximately 20 mL m
Reference solution (ISE REF): approximately 17 mL
Roche Diagnostics
646 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Daily maintenance
Required reagent volumes on green rack
Number of wash cycles: 5 photometric and 15 ISE cycles are recommended. The number of wash cycles must be set by your system administrator on Utility > System
> Wash Racks .
Rack pos.
Auxiliary reagent Wash cycles
ISE
(2 units) c 701 c 702 c 502
(per module)
1
2
SmpCln 1
SysClean
5
15
–
600 μ L
(1)
600
–
μ L 225
–
μ L
3 Activator 15
600 μ L
(1) – –
Important: The dead volume of the used containers must be taken into account additionally.
Table 22-2 Required reagent volumes (dead volume not included)
(1) Only 300 μ L are required for an ISE module with one measuring unit (20 μ L per cycle).
CAUTION
Example A: c 702c 702c 702 combination: 3 x 600 μ L SmpCln 1
= 1800 μ L + 1000 μ L (dead volume of 16 mm sample tube).
Minimum volume = 2800 μ L
Example B: c 701c 502c 502 combination: 600 μ L + 450 μ L SmpCln 1
= 1050 μ L + 100 μ L (dead volume of standard cup).
Minimum volume = 1150 μ L u
For more information about dead volumes, see:
Container specifications (p. 213).
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
Incorrect patient results due to shortage of ISE conditioning solution (Activator) or ISE cleaning solution (SysClean)
If the amount of Activator or SysClean is not sufficient or the sample cup containing the
Activator or SysClean is missing or in an incorrect position, the conditioning or cleaning of the ISE can not be completed.
r Fill a sufficient amount of Activator and SysClean into sample cups.
r Place the sample cups into the correct positions of the green wash rack.
r If an alarm due to insufficient volume of these solutions is issued, all ISE samples measured after the alarm must be rerun.
Roche Diagnostics
Operator’s Manual · 4.2.1
647
22 Maintenance of cobas ISE module
Daily maintenance cobas® 8000 modular analyzer series p To prepare the green wash rack
1 Place sample tubes or cups into positions 1 to 3 on a green rack (wash rack).
1
2
3
Figure 22-1 Green rack with reagents
2
Pipette suitable amounts of auxiliary reagents into the sample tubes. The dead volume of the used containers must be taken into account additionally.
u
See: Table
22-2 Required reagent volumes (dead volume not included) (p. 647)
q Ensure correct positions
Ensure that the sample tubes or cups are positioned as instructed, otherwise no sampling or washing will be performed.
3 Start the washing procedure either at the end of analysis or during operation: u
See:
Washing with green rack at the end of analysis each day (p. 649)
Washing with green rack during continuous operation (p. 650)
s
Roche Diagnostics
648 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Daily maintenance
Washing with green rack at the end of analysis each day
We recommend processing the green wash rack within a Power Off pipe or another maintenance pipe. Then you do not have to perform this maintenance task manually. u
For information on using the maintenance pipe, see:
Power Off Pipe function (p. 601)
Load the green wash rack before executing the maintenance pipe.
CAUTION p To perform washing at the end of analysis
1
Place the green rack into the rack loading area, as described before.
2
Choose Start (global button).
3
Choose Start to begin the washing procedure.
4
After processing the green wash rack, perform a full calibration. For the ISE calibration, always use fresh and unopened calibrators Std(1) and (2).
Incorrect results due to missing calibration r After processing the green wash rack all ISE tests must be calibrated.
r Do not load samples with ISE requests before you have checked the calibration and
QC results for ISE.
u
See
To request an ISE calibration (p. 343).
q If washing is interrupted for some reason, perform (7) Wash Reaction Parts followed by
(4) Cell Blank Measurement. Afterwards, perform (8) Reagent Prime (ALL) (only required for ISE modules).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
649
22 Maintenance of cobas ISE module
Daily maintenance cobas® 8000 modular analyzer series
Washing with green rack during continuous operation
The cobas 8000 instrument offers a function to perform this washing procedure during operation. The function must be activated on Utility > System > Wash Racks .
q Notes for working with the Green Rack during Operation function o A full calibration of the ISE tests is required after the washing procedure. Therefore, we recommend processing the green wash rack immediately before the regular daily calibration.
o The instrument must not be in Standby when this function is activated.
o It is possible to load any other rack together with the green wash rack. o During the washing procedure, ISE tests must be masked ( P.Mask
). Only photometric and immunological tests can be processed. Do not load any samples with ISE requests.
If you load samples with ISE requests, the ISE requests cannot be processed until ISE tests are unmasked again.
o Samples with open ISE requests that were registered before masking the ISE tests will be unloaded. You must reload these samples after processing the green wash rack.
CAUTION p To perform washing during operation
1 Choose Start > Masking and select P.Mask
for the ISE tests.
2 Request a full calibration for all ISE tests on Calibration > Status . For the ISE calibration, always use fresh and unopened calibrators Std(1) and (2).
Incorrect results due to missing calibration r After processing the green wash rack all ISE tests must be calibrated.
r Do not load samples with ISE requests before you have checked the calibration and
QC results for ISE.
u
See
To request an ISE calibration (p. 343).
3 Place the racks in the following sequence into the rack loading area on the same tray: o
Green wash rack o
Calibrator rack containing the ISE calibrators o
QC rack containing the controls for ISE tests
4 Choose Start > Start to start the washing procedure.
5 Check the results for calibration and QC.
6 If the analyzer has generated a valid calibration and the QC results are okay, unmask the ISE tests.
Now the analyzer is ready to process routine samples again.
s
Roche Diagnostics
650 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Daily maintenance
Cleaning the ISE sample probe
Each day at the end of analysis, clean the outside of the ISE sample probe to remove residual solution and precipitation.
q Additional cleaning of the sample probe
When a sample aspiration error occurs, perform maintenance item (18) Sample Probe
Wash. If clogging cannot be eliminated by this maintenance item, the sample probe must be detached and cleaned manually.
A sample probe must be replaced if it is bent or damaged. Positional adjustment is required afterwards.
u
See To perform a sample probe wash (p. 680)
Replacing the ISE sample probe – elimination of clogging (p. 680)
Operator time approximately 1 minute
Materials required m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Lint-free gauze pads m
Paper towel
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
NOTICE Damage to the probes r Do not bend or damage the lower end of the probes during cleaning.
r Move the arm gently. Do not move it up or down.
p To clean the outside of the probe
1 Ensure the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until it is in
Standby.
(Or: Power off the instrument or the module.) q The ISE module has an interlock cover that allows the probe to be moved for cleaning when the top cover is opened.
Roche Diagnostics
Operator’s Manual · 4.2.1
651
22 Maintenance of cobas ISE module
Daily maintenance
2 Open the top cover of the module.
cobas® 8000 modular analyzer series
A
NOTICE
A Paper towel to cover the openings of the ISE dilution vessels
Figure 22-2 Cleaning the outside of the sample probe
3
Cover the openings of the dilution vessels with a paper towel. Make sure no alcohol drips into the ISE dilution vessels.
4
Move the sample probe by hand to an accessible position.
5
Wipe the outside of the sample probe with a gauze pad moistened with alcohol: o
Always wipe from top to bottom.
o
Hold the pipetter arm with one hand and wipe with the other.
Damage to instrument surfaces r Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
q
6
Remove the paper towel from the ISE dilution vessels.
7
Close the top cover.
8
Unmask the module, or continue performing other maintenance tasks.
Alignment and replacement of the sample probe
The sample probe must be replaced if it is bent or damaged.
o Adjust the probe alignment after replacement or whenever the probe is not centered above the pipetting positions.
u
See:
Replacing the ISE sample probe – elimination of clogging (p. 680)
To check the horizontal alignment of a probe (p. 684)
s
Roche Diagnostics
652 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Daily maintenance
Cleaning the ISE drain ports
The waste solution from each ISE unit is drained through a separate drain port to the waste container.
Each day at the end of analysis, clean the outlets of the drain ports for high concentrated waste. Regularly perform this maintenance to prevent the accumulation of crystals and clogging of the drain ports. White crystals on a drain port can reduce the electrode insulation and therefore may lead to inaccurate measurement results.
Operator time approximately 1 minute
Materials required m
Lint-free gauze pads m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
p To clean the outlets of the drain ports for high concentrated waste
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the front door of the ISE module.
Roche Diagnostics
Operator’s Manual · 4.2.1
A Outlets
Figure 22-3
A B
B Drain ports
Rinsing off crystals from the outlet
653
22 Maintenance of cobas ISE module
Daily maintenance cobas® 8000 modular analyzer series
3 Apply deionized water to the drain ports (
B ) and the bottom of the outlets ( A ) to
rinse off crystals.
A
A Drain plate
Figure 22-4 Removing and cleaning the drain plates
CAUTION
4 If crystals are still present, remove the drain plates: o
Loosen the thumbscrews of the drain plates (
).
o Wipe the bottom of the drain plates using gauze pads moistened with deionized water. Remove all crystals.
o
Replace the drain plates.
Incorrect results due to opened front door during analysis
Touching drain port components during operation may cause noise and lead to inaccurate measurement results. r Do not touch the drain port components during operation.
5 Close the front door.
6 If the module was masked, unmask it.
s
Roche Diagnostics
654 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Daily maintenance
Emptying and cleaning the concentrated waste container
The system issues an alarm if the concentrated waste container must be emptied. To prevent disruption of the daily routine, empty the concentrated waste container at the end of each shift. Clean the container if necessary.
Operator time approximately 1 minute for emptying the container
Materials required m
Water m
Disinfectant m
Paper towels
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
CAUTION
Harmful fumes when the contents of the waste container is contacted with bleach
The combination of bleach with the contents of the waste container can cause potentially harmful fumes.
r Do not use bleach to clean the waste container.
NOTICE Damage to the waste container r Do not use alcohol or bleach for cleaning as this may damage the waste container.
Roche Diagnostics
Operator’s Manual · 4.2.1
655
22 Maintenance of cobas ISE module
Daily maintenance cobas® 8000 modular analyzer series p To clean the concentrated waste container
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Locate the white waste container at the rear of the ISE module.
A B C
Roche Diagnostics
656
A Waste container
B Hose
Figure 22-5
C Liquid level sensor assembly
Emptying and cleaning the concentrated waste container
3
Lift the liquid level sensor assembly from the waste container and place it on paper towels.
4
Remove the hose from the waste container and put paper towels under the hose.
5
Dispose of the contents of the concentrated waste container according to your laboratory's biohazardous waste disposal regulations.
6
Rinse the waste container thoroughly with water and dispose of the rinse water in the same manner.
7
Prepare the disinfectant according to the manufacturers’ instructions and pour it into the waste container.
8
Place the waste container back in its original position.
9
Return the liquid level sensor assembly and the hose to the waste container.
10
Dispose of the paper towels according to your laboratory's biohazardous waste disposal regulations. Disinfect the work area.
11
Unmask the module, or continue performing other maintenance tasks.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Weekly maintenance
Weekly maintenance
In this section you will find all maintenance actions for the ISE module that must be performed at least once a week.
u
This section discusses the following maintenance action:
Cleaning the rinse stations (p. 657)
Cleaning the rinse stations
Clean the rinse station of the sample probe at least once a week to prevent bacterial growth or precipitation that may clog the rinse station.
Operator time approximately 2 minutes
Materials required m
Wash bottle m
Cotton swabs m
2% Ecotergent solution m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r
Malfunction due to spilled liquid (p. 582)
r
Interrupt of operation due to interlock system (p. 50)
p To clean the rinse station
1 Select one of these statuses, which both allow to move the sample probe to a position that leaves the rinse station easily accessible: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2
Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ).
u
See
To put a module in Manual Cleaning mode (p. 592)
3
Open the top cover of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
657
22 Maintenance of cobas ISE module
Weekly maintenance cobas® 8000 modular analyzer series
4 Move the pipetter probe to a position that leaves the rinse station easily accessible.
A
A Rinse station
Figure 22-6 Cleaning the ISE rinse station
5 Using cotton swabs moistened with 2% Ecotergent solution, clean the inside of the rinse station.
NOTICE
Roche Diagnostics
658
Figure 22-7 Cleaning the ISE rinse station
6 Inject about 10 mL of 2% Ecotergent solution into the rinse station.
Damage to instrument surfaces r Immediately clean the surface from any Ecotergent spills.
7 Inject about 100 mL of deionized water into the rinse station.
8 Close the top cover.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Weekly maintenance
9 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned. u
To terminate Manual Cleaning mode (p. 593)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
659
22 Maintenance of cobas ISE module
Monthly maintenance
Monthly maintenance
cobas® 8000 modular analyzer series
This section describes the maintenance actions for the ISE module that must be performed at least once a month.
u
This section discusses the following maintenance actions:
Cleaning the ISE dilution vessel (p. 677)
Cleaning the ISE reagent aspiration filters (p. 662)
Checking the ISE dilution vessel
In the ISE dilution vessel, the sample is diluted and mixed with ISE DIL (diluent).
Contamination of the dilution vessel may cause inaccurate measurement results.
Therefore, check the dilution vessel for crystallization and contamination at least every month.
Clean the dilution vessel if necessary.
Operator time approximately 1 minute
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To check the ISE dilution vessel
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
Roche Diagnostics
660 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Monthly maintenance
3 Remove the covers of the ISE measuring compartments.
A B C C B
A Dilution vessel
B Vacuum nozzle and retaining screw
Figure 22-8
C
Checking the dilution vessel
Sipper nozzle and retaining screw
4 Check the dilution vessel (A). For a better view inside the vessel, the vacuum nozzle (B) and the sipper nozzle (C) can be removed.
If crystallization or contamination are visible, perform the cleaning procedure.
u
See:
Cleaning the ISE dilution vessel (p. 677)
5 Close the ISE measurement covers if cleaning is not required.
6 Close the top cover.
7 Unmask the module, or continue performing other maintenance tasks.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
661
22 Maintenance of cobas ISE module
Monthly maintenance
Cleaning the ISE reagent aspiration filters
cobas® 8000 modular analyzer series
The aspiration filters are attached at the end of tube in the ISE reagent containers.
Check the filters each time you replace a reagent container and clean them at least once a month. Clogging of filters will reduce the accuracy of reagent aspiration and data reliability.
This maintenance comprises the following procedures and maintenance items:
1. To clean the ISE reagent aspiration filters
2. To prime and calibrate the ISE module
Operator time approximately 4 minutes
System time
approximately 4:10 minutes for (8) Reagent Prime (ALL, 20 cycles)
Materials required m
Deionized water m
Paper towels
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
CAUTION
Incorrect results due to mixing of ISE reagents
If liquid from the tip of a tube drips into another ISE reagent container, this may lead to incorrect results.
r When removing reagent aspiration tube from a reagent container, ensure the tube does not come into contact with other open reagent containers.
r To reduce the possibility of cross contamination, clean the reagent filters in the order of lowest concentration to highest concentration (i.e., clean the diluent filters, then
ISE IS filters, then ISE REF filters).
p To clean the ISE reagent aspiration filters
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the front door of the ISE module.
Roche Diagnostics
662 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Monthly maintenance
3 Pull out the drawer with the reagent containers.
Figure 22-9 Removing the ISE reagent aspiration filters
4
Unscrew the container cap of the first reagent container.
5
Remove the tube.
Roche Diagnostics
Operator’s Manual · 4.2.1
A ISE reagent aspiration filter
Figure 22-10 Cleaning the ISE reagent aspiration filters
6 Unscrew the filter from the tube end.
663
22 Maintenance of cobas ISE module
Monthly maintenance cobas® 8000 modular analyzer series
7 Clean and rinse the filter with deionized water.
A
CAUTION
A Correct
Figure 22-11 Replacing the ISE reagent aspiration filters
8
Finally, screw the filter on the tube end and place it back into the container (
Incorrect results due to incorrect insertion of an aspiration tube
If the aspiration tube is not inserted correctly, the reagent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube into the container all the way until its end touches the bottom of the container. r Do not bend the aspiration tube.
9
Replace the container.
10
for each aspiration filter.
11
Close the front door.
12
Power on the instrument or module again, if necessary.
s p To prime and calibrate the ISE module
1 Ensure the top cover is locked. Otherwise the interlock function will block operation.
2 Ensure the instrument or the module is in Standby (by masking the module).
3 Choose Utility > Maintenance > (8) Reagent Prime .
Roche Diagnostics
664 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Monthly maintenance
4 Choose Select to open the Reagent Prime window.
Figure 22-12 Reagent Prime window
5 Select one ISE module or both.
6 Select ALL (or IS+DIL if only the dilution vessel was cleaned) from the list box.
7 Enter 20 cycles in the text box and choose Execute .
The prime is complete when the instrument returns to Standby.
8 If the module was masked, unmask it.
9 Calibrate the ISE module before processing routine samples. For the ISE calibration, always use fresh and unopened calibrators Std(1) and (2).
Investigate any problem caused by a failed calibration.
u
See
To request an ISE calibration (p. 343).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
665
22 Maintenance of cobas ISE module
Every two months maintenance
Every two months maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the ISE module that must be performed at least once every two months.
Replacing the Na, K and Cl electrodes
The electrical response level and the slope value (sensitivity) of each measuring electrode slightly decreases with time and use. Replace the ISE measuring electrodes every 2 months or after 9000 tests, whichever occurs first.
u
For information about ISE data alarms and corresponding slope values, see:
This maintenance comprises the following procedures and maintenance items:
1. To replace ISE measuring electrodes
2. To prime lines and check connections
3. To perform an ISE Check and calibrate the ISE units
Operator time approximately 5 minutes, plus 2 minutes for ISE calibration
System time
approximately 5:25 minutes for (8) Reagent Prime (ALL, 30 cycles)
approximately 14 minutes for (2) ISE Check (2 × 10 cycles)
approximately 8 minutes for ISE calibration
Materials required m
Sodium (Na
+
) electrode (yellow) m
Potassium (K
+
) electrode (red) m
Chloride (Cl
-
) electrode (green) m
O-rings (on the electrodes) m
Lint-free gauze pads m
Forceps
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To replace ISE measuring electrodes
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
Roche Diagnostics
666 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
A
22 Maintenance of cobas ISE module
Every two months maintenance
B
3 Remove the covers of the ISE measuring compartments.
C
A ISE measuring electrodes
Figure 22-13
B Release lever
Replacing the measuring electrodes
C Metal clip
4
Disconnect the electrode cords from the electrodes ( A ).
5
Pull the release lever ( B ) toward the RELEASE position to loosen the electrodes
from the mounting block. The lever is equipped with a spring.
6
To lock the lever, press the metal clip (
) near the REF electrode.
7
Use large forceps to remove the ISE electrodes.
8
During the electrode replacement: o
Use cotton swabs or gauze pads to wipe up any liquid spilled in the electrode area or liquid adhering to connecting parts. Remaining liquid on ion selective electrodes may lower measurement precision.
o
If an O-ring from the electrodes remains inside the ISE measuring compartment, use forceps to remove it.
9 Remove the protective caps from both sides of the new electrodes.
q Verify that the connecting part and the new electrodes are provided with O rings.
10 Pull the lever toward the RELEASE position to open the electrode mounting block.
11 Insert new electrodes in the right color-coded position in the ISE measuring compartment.
12 Set the lever to LOCK to fasten the electrodes.
13 Reconnect the color-coded electrode cords. Verify that the color of each cord matches the color of the connected electrode.
14 Close the top cover. s
Roche Diagnostics
Operator’s Manual · 4.2.1
667
22 Maintenance of cobas ISE module
Every two months maintenance
CAUTION cobas® 8000 modular analyzer series p To prime lines and check connections
1 Ensure the top cover is locked. Otherwise the interlock function will block operation.
2 Choose Utility > Maintenance > (8) Reagent Prime .
3 Choose Select to open the Reagent Prime window.
4 Select the ISE module only. Deselect any e 602 modules.
5 Choose All in the Prime Item area.
6 Enter 30 in the Cycles text box and choose Execute .
The prime is complete when the instrument returns to Standby.
7 With top cover closed: Check the connections inside the ISE measuring units.
q Check connections!
Make sure no air bubbles enter the system from the connecting parts and there is no liquid leaking inside the ISE measuring units.
Incorrect results due to missing covers of the ISE units
If the covers of the ISE measuring compartments are not reinstalled after maintenance, the temperature level or the noise level may be affected, leading to incorrect results. r Always reinstall the covers of the ISE units after performing maintenance.
8
Close the covers of the ISE measuring compartments.
9
Close the top cover of the module and lock it.
After installing new ISE electrodes, perform the following procedure to condition
the electrodes: To perform an ISE Check and calibrate the ISE units (p. 668).
s p To perform an ISE Check and calibrate the ISE units
1 Choose Utility > Maintenance .
2 Select Check (2) from the left list.
3 Select (2) ISE Check .
Roche Diagnostics
668 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Every two months maintenance
4 Choose Select to open the ISE Check window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 22-14 ISE Check window
5 Enter 10 in the Cycles text box and choose Execute .
The measured voltages for internal standard solution are printed 10 times for each electrode, but the results at this point can be ignored because the electrodes are in the process of conditioning.
6 After waiting 10 minutes, perform an ISE Check again.
7 Check the results of the ISE Check in the Monitor window.
8 Make sure the difference of the measured voltages for each electrode stays within the following criteria between the first and the second measurements:
Electrode
Na
+
, K
+
, Cl
-
Ref
Criterion
± 0.2 mV from cycle to cycle
7 mV from instrument to instrument, average Ref mV level (over 30 cycles) ± 2 mV on one instrument
Stable criteria during ISE Check Table 22-3
9 Perform another ISE Check if the difference of the measured voltages is greater than ± 0.2 mV.
10 If the module was masked, unmask it.
11 Finally, calibrate the ISE units before you resume routine analysis. For the ISE calibration, always use fresh and unopened calibrators Std(1) and (2).
u
See
To request an ISE calibration (p. 343).
s
669
22 Maintenance of cobas ISE module
Quarterly maintenance
Quarterly maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the ISE module that must be performed at least once every three months.
u
This section discusses the following maintenance actions:
Washing the ISE reagent flow paths (p. 670)
Replacing the ISE pinch valve tubing (p. 672)
Washing the ISE reagent flow paths
After long use, protein material and bacteria may grow in the ISE reagent flow paths extending from the reagent containers to the dilution vessels. Wash the flow paths at least once every three months.
This maintenance comprises the following procedures and maintenance items:
1. To wash the ISE reagent flow paths
Operator time approximately 3 minutes, plus 2 minutes for ISE calibration
System time
approximately 12 minutes for (28) ISE System Wash
approximately 3 minutes for (2) ISE Check (30 cycles)
approximately 8 minutes for ISE calibration
Materials required m
200 mL SysClean solution (10 mL SysClean diluted 1:20 with deionized water) m
Gauze pads m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
p To wash the ISE reagent flow paths
1 Ensure the instrument is in Standby .
2 Open the front door of the ISE module.
3 Pull out the reagent aspiration tubes from the IS and DIL containers and insert them into a container with the diluted SysClean solution.
o
Be careful not to drip solution from the tube into another solution's reagent container.
o
The reagent aspiration filter must be completely immersed in the diluted solution.
4
Choose Utility > Maintenance > (28) ISE System Wash .
Roche Diagnostics
670 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Quarterly maintenance
5 Choose Select to open the ISE System Wash window.
CAUTION
Figure 22-15 ISE System Wash window
6 Select one ISE module or both.
7 Choose Execute . A confirmation window is displayed.
8 Follow the instructions in the confirmation window. The Start button becomes available when the preparation is completed.
9 Pull the aspiration tubes from the SysClean solution. Rinse the filters with deionized water and dry them well.
10 Thoroughly remove the detergent from the surfaces of the tubes using gauze pads moistened with deionized water.
11 Return the reagent aspiration tubes to their original reagent containers.
Incorrect results due to incorrect insertion of the ISE aspiration tubes
If the aspiration tube is not inserted correctly, the reagent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube into the reagent container all the way until its end touches the bottom of the reagent container. r Do not bend the aspiration tube.
12 Follow instructions on screen. The instrument performs a reagent prime automatically. s p To perform an ISE check
1
After the reagent prime has been completed, select (2) ISE Check .
2
Choose Select to display the ISE Check window.
3
Enter 30 cycles in the text box and choose Execute .
The electrode voltage is measured 30 times for each electrode (Na
+
, K
+
, Cl
-
and
Ref) and the results are displayed in the ISE Check report on the Monitor window.
Roche Diagnostics
Operator’s Manual · 4.2.1
671
22 Maintenance of cobas ISE module
Quarterly maintenance cobas® 8000 modular analyzer series
4 Confirm that the measured voltages for internal standard solution are normal and that the difference in data for the same electrode before and after the check is stable within the range of 0.2 mV.
5 Calibrate the ISE module before processing routine samples. Investigate any problem caused by a failed calibration.
u
See
To request an ISE calibration (p. 343).
s
Replacing the ISE pinch valve tubing
After long use, the tubing will gradually wear out and the accuracy of sample aspiration will decrease. Replace the ISE pinch valve tubing once every three months.
Operator time approximately 3 minutes, plus 2 minutes for ISE calibration
System time
approximately 2 minutes for (2) ISE Check (10 cycles)
approximately 8 minutes for ISE calibration
Materials required m
Pinch valve tubing m
Forceps
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To replace the ISE pinch valve tubing
1
Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2
Open the top cover of the module.
Roche Diagnostics
672 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Quarterly maintenance
3 Remove the covers of the ISE measuring compartments.
A
B
CAUTION
A Pinch valve tubing
B Pinch valve
Figure 22-16 Replacing the pinch valve tubing
4
Gently remove both ends of the tubing ( A ) from the connectors and remove the
tubing from the pinch valve (
). Discard the old tubing.
5 Insert the new tubing through the pinch valve and attach both ends of the tubing to the connectors.
Incorrect results due to missing covers of the ISE units
If the covers of the ISE measuring compartments are not reinstalled after maintenance, the temperature level or the noise level may be affected, leading to incorrect results. r Always reinstall the covers of the ISE units after performing maintenance.
q
6 Close the covers of the ISE measuring compartments.
7 Close the top cover.
8 Perform maintenance item (2) ISE Check (10 cycles).
u
See
To perform an ISE check (p. 671).
9 Calibrate the ISE units before you resume routine analysis.
u
See
To prime and calibrate the ISE module (p. 664).
Check connections!
Make sure no air bubbles enter the system from the connectors and there is no liquid leaking inside the ISE measuring units.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
673
22 Maintenance of cobas ISE module
Every six months maintenance
Every six months maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the ISE module that must be performed at least once every six months.
Replacing the ISE reference electrode
Like any ISE electrode, the ISE reference electrode slowly deteriorates with time and use. Therefore, replace the reference electrode every six months, or if the measured voltages of all electrodes become unstable during the ISE check.
Operator time approximately 3 minutes
System time
approximately 5:25 minutes for (8) Reagent Prime (ALL, 20 cycles)
approximately 2 minutes for (2) ISE Check (10 cycles)
approximately 8 minutes for ISE calibration
Materials required m
ISE reference electrode m
O-ring m
Lint-free gauze pads m
Forceps m
Cotton swabs
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To replace ISE reference electrode
1
Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2
Open the top cover of the module.
Roche Diagnostics
674 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
Every six months maintenance
3 Remove the covers of the ISE measuring compartments.
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A Metal clip
Figure 22-17 Replacing the ISE reference electrode
4 Disconnect the electrode cord attached to the ISE reference electrode.
5 Pull the release lever toward the RELEASE position and hold it in this position.
The lever is equipped with a spring.
6
To lock the lever, press the metal clip ( A ) near the REF electrode down, and return
the release lever to the lock position.
7 Carefully sway the REF electrode back and forth to remove it.
8 During the electrode replacement: o
Use cotton swabs or gauze pads to wipe up any liquid spilled in the electrode area or liquid adhering to connecting parts. Remaining liquid on ion selective electrodes may lower measurement precision.
o If an O-ring from the electrode remains inside the ISE measuring compartment, use forceps to remove it.
9 Remove the protective caps from both sides of the new electrode.
q Verify that the connecting part and the new electrode are provided with O rings.
10 Insert the new ISE reference electrode in the ISE measuring compartment. Ensure that the new electrode is provided with an O-ring.
11 Pull the release lever to the RELEASE position. The metal clip will return to its original position and close the REF electrode block.
12 Set the lever to LOCK to fasten the electrode.
13 Reconnect the electrode cord to the electrode.
14 Close the top cover.
675
22 Maintenance of cobas ISE module
Every six months maintenance cobas® 8000 modular analyzer series
15 Unmask the module, or continue performing other maintenance tasks.
After installing the new ISE reference electrode, go through the following procedures before you resume routine operation (these procedures are the same for all ISE electrodes).
u
For further instructions, see:
To prime lines and check connections (p. 668)
To perform an ISE Check and calibrate the ISE units (p. 668)
s
Roche Diagnostics
676 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance
As needed maintenance
This section describes the maintenance actions for the ISE module that must be performed as needed and are not subject to a regular schedule.
u
This section discusses the following maintenance actions:
Cleaning the ISE dilution vessel (p. 677)
Replacing the ISE sample probe – elimination of clogging (p. 680)
Cleaning instrument surfaces (p. 687)
Cleaning the ISE dilution vessel
In the ISE dilution vessel, the sample is diluted and mixed with ISE DIL (diluent).
Contamination of the dilution vessel may cause inaccurate measurement results.
Therefore, check the dilution vessel for crystallization and contamination at least every month. Clean the dilution vessel if necessary.
This maintenance comprises the following procedures and maintenance items:
1. To clean the ISE dilution vessel
2. To prime and calibrate the ISE module
Operator time approximately 5 minutes
System time
approximately 4 minutes for (8) Reagent Prime (IS+DIL, 20 cycles)
Materials required m
Wash bottle m
Pipette m
Cotton swabs m
Deionized water m
Nozzle receptacle
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To clean the ISE dilution vessel
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
677
22 Maintenance of cobas ISE module
As needed maintenance cobas® 8000 modular analyzer series
3 Remove the covers of the ISE measuring compartments.
A B C
A Retaining screw of vacuum nozzle
B Retaining screw of sipper nozzle
Figure 22-18
C Nozzle receptacle
Removing the sipper and the vacuum nozzles
4 Loosen the retaining screws of the vacuum nozzle (
A ) and the sipper nozzle ( B ).
5 Remove both nozzles and place them into the nozzle receptacle (
). Be careful not to damage the nozzles.
A
Roche Diagnostics
678
A Dilution vessel
Figure 22-19 Cleaning the dilution vessel
6
Inject deionized water into the dilution vessel (
A ) and the surrounding area with
the small nozzles to rinse off crystals.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance
7 Clean the inside of the dilution vessel using cotton swabs. Be careful not to bend the small nozzles inside the dilution vessel. Do not clean the area near the nozzles directly with cotton swabs.
If the nozzles were accidentally bent, please contact your Roche service representative or technical support.
8 Aspirate the contents of the dilution vessel with a pipette. Dispose of the contents as waste solution.
9 Reattach the sipper nozzle and the vacuum nozzle.
10 Dispose of the nozzle receptacle (
11 Close the ISE measurement covers.
12 Close the top cover.
After cleaning the ISE dilution vessel, it is important to perform a reagent prime and an ISE calibration.
u
See:
To prime and calibrate the ISE module (p. 664).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
679
22 Maintenance of cobas ISE module
As needed maintenance cobas® 8000 modular analyzer series
Replacing the ISE sample probe – elimination of clogging
It is necessary to detach the probe to clean them inside, eliminate clogging, as well as for replacement. Replace a sample probe when it is bent or otherwise damaged.
This maintenance comprises the following procedures and maintenance items:
1. To perform a sample probe wash
4. To reattach the sample probe
5. To check the horizontal alignment of a probe
6. To perform an air purge and check the operation of the probe
7. To perform a Mechanism Check
Operator time approximately 5 minutes
System time
approximately 1:40 minutes for (5) ISE Probe Check
approximately 0:40 minutes for (6) Air Purge
approximately 2:30 minutes for (3) Mechanism Check (10 cycles)
approximately 8:00 minutes for ISE calibration
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
Materials required m
Sample probe (in case replacement is required) m
Cleaning wire (stainless steel) 0.2 mm diameter m
Lint-free gauze pads m
Deionized water p To perform a sample probe wash q This procedure can be used to wash a clogged sample probe.
1 Ensure the instrument is in Standby or the module is masked.
2 Choose Utility > Maintenance > (18) Sample Probe Wash .
3 Choose Select to open the Sample Probe Wash window.
4 Specify a number of cycles for washing in the ISE Wash Cycles text box (5 cycles are recommended).
5 Choose Execute .
The inside of the sample probe is washed with SmpCln 1 (basic wash). q If sample aspiration errors occur frequently or if an alarm for clogging of the sample probe occurs and is not reset after cleaning (maintenance item (18) Sample Probe
Wash), the sample probe must be detached and clogging must be eliminated.
If the sample probe is still clogged, continue with the next procedures.
s
Roche Diagnostics
680 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance p To detach the sample probe
1 Power off the instrument to ensure the liquid level sensor is not electrified.
2 Open the top cover of the module.
A B C D
Roche Diagnostics
Operator’s Manual · 4.2.1
q
A Arm cover
B Tubing
Figure 22-20
C Probe seal
D Connector of liquid level sensor
Removing the arm cover of a pipetter
3
Remove the arm cover ( A ) by pressing the arm cover releases on either side and
gently lift the cover. This exposes the wires and tubing.
When detaching the tubing, water will be flowing out of the tip of the sample probe. Be sure to work above the rinse station.
4
Unscrew the tubing ( B ) from the probe.
5
Locate the probe seal ( C ) either on the end of the tubing or in the retaining nut.
Take care not to drop and loose the probe seal.
6 Disconnect the connector of the liquid level sensor (
7 Lift the probe from the probe arm.
s
681
22 Maintenance of cobas ISE module
As needed maintenance cobas® 8000 modular analyzer series p To eliminate clogging
1 To eliminate clogging, use probe cleaning wire (stainless steel) with 0.2 mm diameter.
PP
Figure 22-21 Unclogging the probe
2 Insert the probe cleaning wire into the probe tip and run it through the probe.
3 Rinse the inside of the probe thoroughly with deionized water, then wipe the probe with clean lint-free gauze pads.
s
Roche Diagnostics
682 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance p To reattach the sample probe
1 Insert the probe into the probe arm. The tab on the probe must slide into the holding slot on the pipetter arm to ensure proper alignment.
2 Reconnect the connector of the liquid level sensor.
A
A Probe seal
Figure 22-22 Location of the probe seal, correct position of the tubing
3
When reconnecting the tubing, make sure a new probe seal is in place.
q A probe seal, once pulled off, should not be reused since the edge will be deformed. A new probe always comes with a new seal.
4
Reattach the arm cover; the rear section first and then the front section.
5
Close the top cover.
6
Power on the instrument or the module.
7
Go through the following procedures before you resume routine operation: o
To check the horizontal alignment of a probe (p. 684)
o
To perform an air purge and check the operation of the probe (p. 685)
o
To perform a Mechanism Check (p. 686)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
683
22 Maintenance of cobas ISE module
As needed maintenance
NOTICE cobas® 8000 modular analyzer series p To check the horizontal alignment of a probe
1 Choose Utility > Maintenance > (2) Check .
2 Select (5) ISE Probe Check .
3 Choose Select to open the corresponding window.
4 Choose Execute to start the Probe Check mode.
The probe moves to its first stop position (e.g., the rinse station).
5 Press the Next button in the user interface to move the probe to the dilution vessel.
6 Visually check the alignment of the probe through the top cover of the module.
The probe tip must be centered above the dilution vessel.
Damage to the instrument
The correct alignment of the probe is critical for proper functioning of the instrument.
Failure to correctly align the probe can result in damage to the instrument and/or incorrect test results.
r Do not bend a probe sharply. This can crimp the probe, which must then be replaced.
r We recommend that you contact your local Roche service representative or technical support.
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
7
If necessary, firmly hold the pipetter arm and gently bend the probe over its entire length in an arc to manually adjust the position.
8
Press the Next button to move the probe to the home position.
9
To terminate the ISE Probe Check mode, choose Stop in the Confirmation window.
s
Roche Diagnostics
684 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance p To perform an air purge and check the operation of the probe
1 Choose Utility > Maintenance > (6) Air Purge .
2 Choose Select to open the Air Purge window.
Figure 22-23 Air Purge window
3 Select the desired module.
4 In the Syringe area, select the syringe to be purged of air (or all syringes).
5 Choose Execute to initiate the air purge.
The procedure is finished when the instrument returns to Standby.
Now continue with the mechanism check.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
685
22 Maintenance of cobas ISE module
As needed maintenance cobas® 8000 modular analyzer series p To perform a Mechanism Check
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
1
Choose Utility > Maintenance > (2) Check .
2
Select (3) Mechanism Check .
3
Choose Select to open the Mechanism Check window.
Roche Diagnostics
686
Figure 22-24 Mechanism Check window
4
To select only a particular module, clear the SU check box. Then select the desired module.
5
Enter 10 in the Cycles text box and choose Execute .
All mechanisms of the selected module will operate.
6
Visually check through the closed top cover that the following conditions are maintained: o
The probe descends into the center of the reaction cells.
o
The probe does not contact any other parts.
o
At the rinse stations, the outside of the probe is rinsed with water.
After the mechanism check, the instrument returns to Standby. If an error is detected, an instrument alarm will be issued.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 22 Maintenance of cobas ISE module
As needed maintenance
Cleaning instrument surfaces
Spills on the instrument surface could be biohazardous and damage the surface.
Clean up all spills immediately. Use this procedure to ensure that surfaces on all modules are clean.
Materials required m
Disposable cloth or paper towels m
Laboratory disinfectant (no bleach)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
NOTICE Damage to instrument surfaces r Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
p To clean instrument surfaces
1
Power off the complete instrument or the desired module.
Or: Ensure the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until it is in
Standby.
u
See:
Instrument statuses for maintenance (p. 590)
2
Clean the module surfaces using a cloth or paper towel moistened with disinfectant.
Clean up all spills immediately. Ensure that all surfaces are clean.
3
Unmask the module if it was masked.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
687
22 Maintenance of cobas ISE module
As needed maintenance cobas® 8000 modular analyzer series
Roche Diagnostics
688 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
23 Maintenance of photometric modules
Maintenance of photometric modules
23
This chapter describes the maintenance actions required for correct and efficient running of the c 701, c 702 and c 502 modules. The schedule contains all required periodic maintenance actions (daily, weekly, monthly…) as well as maintenance actions that are performed as needed.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
23
Option 1: Cleaning the incubator bath with the instrument powered off .... 723
Option 2: Attaching reaction cells (without cleaning the incubator bath).... 724
Replacing the pipetter probes – elimination of clogging ....................................... 747
689
23 Maintenance of photometric modules
Table of contents cobas® 8000 modular analyzer series
Replacing the pipetter probes (c 701 / c 702 module)...................................... 747
Roche Diagnostics
690 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Maintenance schedule for photometric modules
Maintenance schedule for photometric modules
The following table lists all maintenance actions required for the photometric modules:
Daily
Weekly
Monthly
Quarterly
Every six months
As needed
Procedure
Cleaning the discharge chute for reagent caps
Checking the reagent pack gripper
Replacing reaction cells and cleaning incubator bath
Cleaning the detergent aspiration filters
Cleaning the filters behind front doors
Cleaning the ultrasonic mixers
Cleaning the filter of the solenoid valve
(2) l
Cleaning the water inlet filter
Replacing nozzle tips on cell rinse nozzles
Replacing the pipetter probes – elimination of clogging
l l l
l l l l l l l
– l l l l l c 701 c 702 c 502 Instrument status l l l
–
(1) l l l l
MC/PO
SB/MM/PO l l l l
SB/MM
SB/MM/PO l
– l l l
–
MC/PO
SB/MM/PO l l
– l
MC/PO
IBC/PO l l l l l l l l l l l l l l
– l l l l l l l
SB/MM/PO
SB/MM/PO
IBC/PO/SB/MM
PO
CPL/PO
PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
PO
SB/MM/PO
Cleaning the waste box for reagent caps
Cleaning the reagent pack gripper
–
– l l
–
–
SB/MM/PO
MC/PO
Maintenance schedule – photometric modules Table 23-1
(1) From any operational status, such as Standby or Rack Reception mode, or within a maintenance pipe.
(2) Replace the lamp if the photometer check value exceeds 14 000 or when used for more than 750 hours of power-on time.
Instrument status (mode)
PO
SB
MM
MC
IBC
CPL
Power Off (or module powered off on Utility > System Configuration > Module
Settings )
Standby mode
Module Masked ( Start > Masking > Module Masking ), puts single modules in a status equal to Standby
Manual Cleaning mode
Incubator Bath Cleaning mode
Change Photometer Lamp mode u
For more information, see: Instrument statuses for maintenance (p. 590).
Roche Diagnostics
Operator’s Manual · 4.2.1
691
23 Maintenance of photometric modules
Maintenance schedule for photometric modules cobas® 8000 modular analyzer series
CAUTION
Incorrect results or damage to the instrument due to non-compliance of maintenance intervals
The intervals for maintenance and checkup recommended in this document are independent of the system operation time unless otherwise noted (e.g., maintenance actions which are based on test count or time). If the intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
r Observe the maintenance intervals stated in this document.
u
For information about intervals based on test count or time, see:
Periodic replacement of parts (p. 629).
Figures of photometric modules All figures in this chapter are used for illustrative purpose. As the maintenance tasks are performed similarly on all photometric modules, sometimes only the c 701 module is shown as an example for all modules (unless otherwise noticed).
Figure 23-1 Figures of c 701 / c 702 and c 502 modules
Roche Diagnostics
692 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Daily maintenance
Daily maintenance
This section describes all maintenance actions for the photometric modules that must be performed every day.
Contamination of flow paths or pipetter probes may cause incorrect measurement results or clogging. Therefore, make sure to regularly perform the stated maintenance procedures.
u
This section discusses the following maintenance actions:
Processing green wash rack (p. 693)
Cleaning the pipetter probes (p. 693)
Cleaning cell rinse nozzles (p. 699)
Processing green wash rack
Washing with a green wash rack must be processed once every 24 hours. q This is a combined maintenance action for the ISE module and all photometric modules .
Therefore, the procedures are described in the chapter for ISE maintenance actions. u
See Processing green wash rack (p. 646)
Cleaning the pipetter probes
Each day at the end of analysis, clean the outside of the pipetter probes (sample probe, reagent probes, and c 502 detergent probe) to remove residual solution and precipitation.
q Additional cleaning of the pipetter probes
When a sample aspiration error occurs, perform maintenance item (18) Sample Probe
Wash. If clogging cannot be eliminated by this maintenance item, the sample probes must be detached and cleaned manually.
A probe must be replaced if it is bent or damaged. Positional adjustment is required afterwards.
u
See To perform a sample probe wash (p. 747)
Replacing the pipetter probes – elimination of clogging (p. 747)
Operator time approximately 3 minutes per module
System time approximately 0:45 minutes for (1) Reset
Materials required m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Lint-free gauze pads m
Paper towel
Roche Diagnostics
Operator’s Manual · 4.2.1
693
23 Maintenance of photometric modules
Daily maintenance
NOTICE cobas® 8000 modular analyzer series
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
Damage to the probes r Do not bend or damage the lower end of the probes during cleaning. Move the arm gently. Do not move it up or down.
p To clean the outside of the c 701 / c 702 sample probes
1
Select one of these statuses, which both allow to move the sample probes to better accessible positions: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3 Choose Maintenance Monitor to check that the module is in Manual Cleaning mode.
q Do not use Standby to perform this maintenance procedure. This would end up in an
E.Stop (emergency) alarm for all modules. Then the system would require either a complete power off or at least a reset ( Utility > Maintenance ) to resume normal operation.
Roche Diagnostics
694 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F[
4 Open the rear cover of the module.
A
23 Maintenance of photometric modules
Daily maintenance
A Plexiglass cover
Figure 23-2 Removing the plexiglass cover above the sample probes
5
Remove the plexiglass cover.
NOTICE
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 23-3 Cleaning the outside of the c 701 / c 702 sample probes
6
Move the sample probe by hand to an accessible position.
7
Wipe the outside of the sample probe with a gauze pad moistened with alcohol: o
Always wipe from top to bottom.
o
Hold the pipetter arm with one hand and wipe with the other.
Damage to instrument surfaces r Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
695
23 Maintenance of photometric modules
Daily maintenance cobas® 8000 modular analyzer series q
8 Reattach and close all covers.
9 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
Additionally perform a reagent registration via Reagent > Setting > Reagent
Registration .
u
To terminate Manual Cleaning mode (p. 593)
Alignment and replacement of pipetter probes
Sample probes must be replaced if they are bent or damaged.
o Adjust the probe alignment after replacement or whenever the probe is not centered above the pipetting positions.
u
See:
Replacing the pipetter probes – elimination of clogging (p. 747)
To check the horizontal alignment of a probe (p. 752)
s p To clean the outside of the c 701 / c 702 reagent probes and all c 502 probes
1
Select one of these statuses, which both allow to move the pipetter probes to better accessible positions: o c 701 / c 702: Manual Cleaning mode (described here) o c 502: Standby o
Power off (instrument or module) q The c 502 module has an interlock cover that allows the probes to be moved for cleaning when the top cover is opened.
q
2
Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3
Choose Maintenance Monitor to check that the module is in Manual Cleaning mode.
Do not use Standby to perform this maintenance procedure. This would end up in an
E.Stop (emergency) alarm for all modules. Then the system would require either a complete power off or at least a reset ( Utility > Maintenance ) to resume normal operation.
4
For c 701 / c 702 modules: Open the top cover.
Roche Diagnostics
696 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F[
23 Maintenance of photometric modules
Daily maintenance
5 For c 502 modules: Open the top cover and the cover around the reagent probe additionally. Alarms are issued as the top cover is monitored by the interlock function.
A B
F
NOTICE q
A Sample probe ( c 502 sample probe is used to show cleaning of all probes)
B Reagent probe
Figure 23-4 Cleaning the outside of the probes
6
Move the pipetter probes by hand to an accessible position.
7
Wipe the outside of the probes with a gauze pad moistened with alcohol: o
Always wipe from top to bottom.
o
Hold the pipetter arm with one hand and wipe with the other.
Damage to instrument surfaces r Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
Use a new lint-free gauze pad for each probe to prevent cross contamination.
Roche Diagnostics
Operator’s Manual · 4.2.1
697
23 Maintenance of photometric modules
Daily maintenance
F cobas® 8000 modular analyzer series
Roche Diagnostics
698 q
A
A Shield pipe (exists only on c 502 modules)
Figure 23-5 Cleaning the shield pipe
8
For c 502 modules only: Also wipe the inside of the shield pipe (
pad moistened with alcohol.
9
Reattach and close all covers.
10
To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
On c 701 and c 702 modules, additionally perform a reagent registration via
Reagent > Setting > Reagent Registration .
Alignment and replacement of c 701 / c 702 reagent probes
Pipetter probes must be replaced if they are bent or damaged.
o Adjust the probe alignment after replacement or whenever the probe is not centered above the pipetting positions.
o For c 502 modules: The replacement of a probe can only be performed by persons who received a special training for extended maintenance tasks.
u
See:
Replacing the pipetter probes – elimination of clogging (p. 747)
To check the horizontal alignment of a probe (p. 752)
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Daily maintenance
Cleaning cell rinse nozzles
Each day at the end of analysis, clean the cell rinse nozzles. Regular cleaning prevents contamination, crystal formation, and clogging. Crystallization of reaction solution on the outer surface of rinse nozzles may lead to inaccurate results or water overflow from reaction cell.
Replace a nozzle tip if its corner or bottom is worn. u
See Replacing nozzle tips on cell rinse nozzles (p. 743)
Operator time approximately 5 minutes per c 701 / c 702 module approximately 3 minutes per c 502 module
System time approximately 0:45 minutes for (1) Reset
Materials required m
Deionized water m
Lint-free gauze pads
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
p To clean the cell rinse nozzles
1
Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
Roche Diagnostics
Operator’s Manual · 4.2.1
699
23 Maintenance of photometric modules
Daily maintenance
F[
2 Open the top cover of the module.
A cobas® 8000 modular analyzer series
B C
F
A Cell rinse unit 3
B Cell rinse unit 2
Figure 23-6
C Cell rinse unit 1
Cell rinse units ( c 701 module is shown as example)
A B
Roche Diagnostics
700
A Retaining screw
Figure 23-7 Cell rinse unit ( c 502)
B Cell rinse unit
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Daily maintenance
Figure 23-8 Cleaning the cell rinse nozzles ( c 701 used as example)
3 Moisten a lint-free gauze pad with deionized water and gently wipe all nozzles in a downward motion. Be careful not to bend the nozzles.
4 Close the top cover.
5 If the module was masked, unmask it.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
701
23 Maintenance of photometric modules
Weekly maintenance
Weekly maintenance
cobas® 8000 modular analyzer series
This section describes all maintenance actions for the photometric modules that must be performed at least once a week.
u
This section discusses the following maintenance actions:
Washing the reaction parts (p. 702)
Cleaning the cell covers (p. 704)
Cleaning the rinse stations (p. 706)
Cleaning the discharge chute for reagent caps (p. 709)
Checking the reagent pack gripper (p. 711)
Washing the reaction parts
Contamination of the reaction cells or the waste solution flow path will result in incorrect measurement results. Wash the reagent probes and reaction cells at least once a week.
u
For instructions on how to remove reaction cells, see
Replacing reaction cells and cleaning incubator bath (p. 713).
After washing the reaction system, perform a cell blank measurement to monitor the condition of the reaction cells.
This maintenance comprises the following procedures and maintenance items:
1.
To wash the reaction system (p. 702) (maintenance item (7) Wash Reaction Parts)
2.
To perform a cell blank measurement (p. 703) (maintenance item (4) Cell Blank
Measurement)
3.
To view the cell blank measurement results (p. 703)
Operator time approximately 2 minutes per module
System time approximately 27 minutes for (7) Wash Reaction Parts, plus 15 minutes for (4) Cell Blank Measurement
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
p To wash the reaction system
1
Ensure the instrument or the module is in Standby (by masking the module).
2
Choose Reagent > Status .
Roche Diagnostics
702 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Weekly maintenance
3 Check that the remaining amounts of detergent are sufficient. If necessary, add the required reagent or detergent.
Detergent Description Consumption
SmpCln 1
Reagent probe and reaction cell detergent
Table 23-2
D1
Basic wash
NAOHD reagent packs on both disks approx. 1 mL c 701 / c 702: approx.
72 mL for each reagent disk c 502: approx. 58 mL
Wash the reaction system—required amounts of detergent
4 Choose Utility > Maintenance > (7) Wash Reaction Parts .
5 Choose Select to open the Wash Reaction Parts window.
6 Select the desired module.
7 Choose Execute .
The procedure is finished when the module returns to Standby. Now proceed with a cell blank measurement.
s p To perform a cell blank measurement
1
Choose Utility > Maintenance > (4) Cell Blank Measurement .
2
Select the desired module.
3
Choose Execute .
Absorbance values of all cells filled with water are measured.
The results are printed automatically in the Cell Blank Measurement report.
s p To view the cell blank measurement results
1 Choose Print (global button) > History to view the recent Cell Blank
Measurement report.
2 Check if any cells are listed in the Abnormal Cell List area at the top of the report.
Whenever the cell blank value of a reaction cell falls out of the normal range, that reaction cell’s number is printed in this area. These cells will be excluded from measurements.
Normal cell blank values are: o
Value < 14 000 for the no. 1 cells on all modules and o
A difference between the no. 1 cell and all other cells of less than ± 1000
(± 0.1 Abs).
3
If no cells are listed in the Abnormal Cell List area, you can continue without any further action.
If any reaction cells are affected, remove all reaction cells from the reaction disk and replace the listed cells by new ones.
u
For detailed instructions, see:
Replacing reaction cells and cleaning incubator bath (p. 713).
s
Roche Diagnostics
Operator’s Manual · 4.2.1
703
23 Maintenance of photometric modules
Weekly maintenance
Cleaning the cell covers
cobas® 8000 modular analyzer series
The cell covers serve to prevent contamination by reagent and reaction solution. If reagent adheres to the front or rear of a cell cover, the analytical accuracy may decrease. Clean the cell covers at least once a week, including the U-shaped covers.
Operator time approximately 9 minutes per c 701 / c 702 module approximately 5 minutes per c 502 module
Materials required m
Cotton swabs m
Lint-free gauze pads m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
p To clean the cell covers
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
F[
Figure 23-9 Removing the cell covers ( c 701 / c 702 module)
Roche Diagnostics
704 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F
23 Maintenance of photometric modules
Weekly maintenance
Figure 23-10 Removing the cell covers above ultrasonic mixers ( c 502 module)
3 Remove the cell covers above the ultrasonic mixers.
A B
Roche Diagnostics
Operator’s Manual · 4.2.1
A Cell cover
Figure 23-11 Cleaning all cell covers
B U-shaped covers ( c 701 / c 702 only)
4
Wipe the front and rear of all cell covers using a gauze pad moistened with alcohol.
Wipe the openings of the cell covers using a cotton swab moistened with alcohol.
q Be careful not to splash alcohol into the reaction cells.
q
5
For c 701 / c 702 modules: Clean the U-shaped covers (
o
Pinch the sides of the U-shaped covers and pull them off the cell covers.
o
Wash the U-shaped covers with deionized water. If dust and dirt do not come off, wipe the U-shaped covers using a cotton swab moistened with alcohol.
o
Reattach the dried U-shaped covers.
If you are also performing monthly maintenance, we recommend that you perform the following action now: u
See:
Replacing reaction cells and cleaning incubator bath (p. 713).
6 Put the cell covers back in place.
7 Close the top cover.
705
23 Maintenance of photometric modules
Weekly maintenance cobas® 8000 modular analyzer series
8 Unmask the module, or continue performing other maintenance tasks.
s
Cleaning the rinse stations
Clean the rinse stations of the sample and reagent probes at least once a week to prevent bacterial growth or precipitation that may clog the rinse station.
Operator time approximately 3 minutes per module
System time approximately 0:45 minutes for (1) Reset
Materials required m
Wash bottle m
Cotton swabs m
Alcohol (e.g., isopropyl alcohol or ethanol) m
2% Ecotergent solution m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
F[ p To clean the rinse stations (c 701 / c 702 module)
1
Select one of these statuses, which both allow to move the pipetter probes to positions that leave the rinse stations easily accessible: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3 Open the top cover, rear cover and the plexiglas cover of the module.
Roche Diagnostics
706 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Weekly maintenance
4 Move the pipetter probes to positions that leave the rinse stations easily accessible.
Figure 23-12 Rinse stations of sample probe and reagent probe ( c 701 / c 702 module)
5 6 / 7
NOTICE
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 23-13 Cleaning the rinse stations of sample probe and reagent probe (reagent probe rinse station is shown as example)
5
Using cotton swabs moistened with 2% Ecotergent solution, clean the inside of the rinse stations.
6
Inject about 10 mL of 2% Ecotergent solution into each rinse station.
Damage to instrument surfaces r Immediately clean the surface from any Ecotergent spills.
7
Inject about 100 mL of deionized water into each rinse station.
8
Return the sample and reagent probes to their original positions.
9
Close all covers of the module.
10
To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
Additionally perform a reagent registration via Reagent > Setting > Reagent
Registration .
u
To terminate Manual Cleaning mode (p. 593)
s
707
23 Maintenance of photometric modules
Weekly maintenance
F cobas® 8000 modular analyzer series p To clean the rinse stations (c 502 module)
1
Select one of these statuses, which both allow to move the pipetter probes to positions that leave the rinse stations easily accessible: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3 Open the top cover of the module.
4 Move the pipetter probes to positions that leave the rinse stations easily accessible.
5
Figure 23-14 Rinse stations of sample, Ecotergent, and reagent probe ( c 502 module)
6 / 7 8
A B
A Rinse station (reagent probe rinse station is shown as example) B Drying cylinder of c 502 sample probe
Figure 23-15 Cleaning the rinse stations of sample, Ecotergent, and reagent probe
5
Using cotton swabs moistened with 2% Ecotergent solution, clean the inside of the rinse stations.
Roche Diagnostics
708 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
NOTICE
23 Maintenance of photometric modules
Weekly maintenance
6 Inject about 10 mL of 2% Ecotergent solution into each rinse station.
Damage to instrument surfaces r Do NOT splash Ecotergent solution into the drying cylinder.
r Immediately clean the surface from any Ecotergent spills.
7
Inject about 100 mL of deionized water into each rinse station.
8
Only in the sample probe rinse station: Wipe the drying cylinder with a cotton swab moistened with ethanol or alcohol.
9
Close the top cover.
10
To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned. u
To terminate Manual Cleaning mode (p. 593)
s
Cleaning the discharge chute for reagent caps
Clean the inner sides and the base plate of the discharge chute once a week.
Otherwise spills from reagent caps may adhere and damage the material.
Operator time approximately 3 minutes per c 702 module
Materials required m
Cotton swabs m
Lint-free gauze pads m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
F p To clean the discharge chute for reagent caps (c 702 only)
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Choose Overview > Reagent Manager Overview .
3 Make sure that there are no reagent packs in the buffer rotor.
u
If the buffer rotor is not empty, follow one of the procedures:
To manually control reagent packs on the buffer rotor (p. 370)
To unload reagent packs from the reagent manager buffer rotor (p. 376)
Roche Diagnostics
Operator’s Manual · 4.2.1
709
23 Maintenance of photometric modules
Weekly maintenance cobas® 8000 modular analyzer series
4 Take out the cap waste box and dispose of the reagent caps.
CAUTION
Figure 23-16 Removing the cover of the discharge chute
5 Loosen the retaining screw at the discharge chute and remove the cover.
Injury due to contact with mechanisms inside the reagent manager r Do not insert your hands or fingers deeply into the opening.
r Use a long cotton swab stick.
A
Roche Diagnostics
710
A Inner surfaces
Figure 23-17 Cleaning the inner surfaces of the discharge chute
6 Clean the inner surfaces of the discharge chute with gauze pads and cotton swabs moistened with deionized water.
7 Return the cover and fasten the retaining screw at the discharge chute.
8 Return the cap waste box back in place.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Weekly maintenance
9 If you have emptied the cap waste box, choose Waste Box Reset to reset the counter to zero.
10 Unmask the module if it was masked.
s
Checking the reagent pack gripper
Check the bottom side of the gripper weekly for reagent splashes. Clean the surface if reagent splashes are found.
u
See: Cleaning the reagent pack gripper (p. 758)
Operator time approximately 5 minutes per c 702 module
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
F p To check the bottom side of the gripper for reagent splashes (c 702 only)
1
Select one of these statuses, which both allow to move the reagent gripper to a better accessible position: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3 Choose Maintenance Monitor to check that the module is in Manual Cleaning mode.
4 Open the top cover.
Roche Diagnostics
Operator’s Manual · 4.2.1
711
23 Maintenance of photometric modules
Weekly maintenance cobas® 8000 modular analyzer series
5 Move the reagent gripper with your hand to an accessible position.
Roche Diagnostics
712
A q
A Bottom side of reagent gripper
Figure 23-18 Check for reagent splashes
6 Check the bottom side of the reagent gripper for reagent splashes.
Clean the surface if required.
u
See:
Cleaning the reagent pack gripper (p. 758)
7 Manually move the gripper either to the leftmost or the rightmost position of the module.
If the gripper is not moved to the leftmost or rightmost position, the module will not resume operation and an alarm will be issued.
8 Close the top cover.
9 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
Additionally perform a reagent registration via Reagent > Setting > Reagent
Registration .
u
To terminate Manual Cleaning mode (p. 593)
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
Monthly maintenance
This section describes all maintenance actions for the photometric modules that must be performed at least once a month.
u
This section discusses the following maintenance actions:
Replacing reaction cells and cleaning incubator bath (p. 713)
Cleaning the detergent aspiration filters (p. 725)
Cleaning the filters behind front doors (p. 727)
Replacing reaction cells and cleaning incubator bath
The reaction cells gradually deteriorate with use. Contamination inside the incubator bath or on the photometric window will reduce the reproducibility of measurement results.
Replace the reaction cells and clean the incubator bath at least once a month.
This maintenance comprises the following procedures and maintenance items:
Procedures for c 701 / c 702 modules
1.
To put the module into Incubator Bath Cleaning mode (c 701 / c 702 modules)
2.
To remove reaction cells and to clean the incubator bath (c 701 / c 702 modules)
3.
Procedures for c 502 modules 1.
To put the module into Incubator Bath Cleaning mode (c 502 modules) (p. 719)
2.
To remove reaction cells and to clean the incubator bath (c 502 module) (p. 720)
3.
To reinstall reaction parts and to terminate Incubator Bath Cleaning mode (c 502 module) (p. 722)
Optional procedures Option 1: Cleaning the incubator bath with the instrument powered off (p. 723)
Option 2: Attaching reaction cells (without cleaning the incubator bath) (p. 724)
Operator time approximately 16 minutes per c 701 module approximately 20 minutes per c 702 module approximately 15 minutes per c 502 module
System time approximately 2 minutes for draining the incubator bath approximately 5–20 minutes for refilling the incubator bath (depending on module and water exchange rate, see following table) approximately 27 minutes for (7) Wash Reaction Parts approximately 15 minutes for (4) Cell Blank Measurement
Materials required m
Reaction cells m
Ecotergent (consumption see following table) m
Deionized water m
Cotton swabs m
Lint-free gauze pads m
Deionized water or 2% Ecotergent solution
Roche Diagnostics
Operator’s Manual · 4.2.1
713
23 Maintenance of photometric modules
Monthly maintenance cobas® 8000 modular analyzer series
Consumption of Ecotergent The following table shows the detergent consumption and the time for exchanging the incubator water depending upon the setting of the exchange rate. Set the water exchange rate depending on the water quality in respect of bacterial impureness.
Select the low exchange rate only if the water quality is good.
High exchange rate (1)
( long mode )
Consumption of
Ecotergent (approx.) c c
701 /
702
15 mL
Runtime (approx.)
(3)
Table 23-3 c 502 c 701 / c 702
8 mL
17 min c 502 19 min
High exchange rate vs. low exchange rate
Low exchange rate (2)
( short mode )
12 mL
4 mL
9 min
5 min
(1) Select the High Water Exchange Rate check box under Utility > System > Analyzer Settings .
(2) Clear the High Water Exchange Rate check box.
(3) Time for incubator water exchange.
CAUTION
Incorrect results due to insufficient Ecotergent volume
A reduced concentration of Ecotergent may cause bacteria growth in the incubator bath and lead to a decreased measurement accuracy. The throughput may also be reduced if reaction cells are excluded from measurement by abnormal cell blank values.
r Perform maintenance item (10) Incubator Bath Cleaning at least once a month.
r Ensure the remaining detergent volume is sufficient before performing this maintenance item.
r Do not blend Ecotergent with other detergents.
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Malfunction due to spilled liquid (p. 582)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
q Only for c 701 / c 702 or c 502 modules at the same time
Incubator Bath Cleaning cannot be performed on different module types at the same time.
Therefore select only c 701 / c 702 modules or c 502 modules. Once the incubator baths have been cleaned and the function is terminated (by F1 or Continue button), the
Incubator Bath Cleaning can be started for the other module type.
Roche Diagnostics
714 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F[
23 Maintenance of photometric modules
Monthly maintenance p To put the module into Incubator Bath Cleaning mode (c 701 / c 702 modules)
1
Choose Overview > Reagent Overview .
2
Check that the remaining volume of Ecotergent on each module is sufficient
(> 12 mL).
If necessary, load a new reagent pack on the outer ring of reagent disk B. On c 701 modules, additionally perform a reagent registration afterwards.
3
Select one of these statuses for this procedure: o
Recommended and described here: Incubator Bath Cleaning mode (incubator water is automatically drained and refilled after cleaning). Choose this mode if you want to clean the incubator bath at the same time.
o
Power Off (all mechanical parts can be moved by hand) u
See
Option 1: Cleaning the incubator bath with the instrument powered off (p. 723).
o
If only reaction cells must be replaced, choose Change Reaction Cell mode
(reaction disk can be rotated by hand). Follow the next steps analogous to
Incubator Bath Cleaning mode. u
After removing the reaction cells, follow the procedure:
Option 2: Attaching reaction cells (without cleaning the incubator bath) (p. 724).
4
Ensure the instrument or the module is in Standby (by masking the module).
5
Choose Utility > Maintenance > (10) Incubator Bath Cleaning .
6
Select the desired module and choose Execute .
The water is drained from the incubator bath.
7
Choose Maintenance Monitor .
8
Wait until Incubator Bath Cleaning (Wait) is displayed before starting with the next procedure.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
715
23 Maintenance of photometric modules
Monthly maintenance
F[ cobas® 8000 modular analyzer series p To remove reaction cells and to clean the incubator bath (c 701 / c 702 modules)
1
Ensure the module is in Incubator Bath Cleaning mode.
2
Open the top cover of the module.
A B
A Cell cover
B Bayonet cap (only on the left-most cell cover)
Figure 23-19 Removing the cell covers ( c 701 / c 702 modules)
3
Remove all cell covers.
One cell cover is equipped with two bayonet caps (
caps to lock or unlock the bayonet lock.
Roche Diagnostics
716
Figure 23-20 Removing reaction cells ( c 701 / c 702 modules)
4 Remove all cell rinse units.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
5 Remove the reaction cells from the reaction disk. Do not touch the surfaces of reaction cells that are to be used again.
6 Discard the used reaction cells.
If only reaction cells must be replaced (without cleaning the incubator bath), continue with the following procedure: u
To attach reaction cells (without cleaning the incubator bath) (p. 724).
A B
A Cleaning the incubator bath with a gauze pad
Figure 23-21
B
Cleaning the incubator bath ( c 701 / c 702 modules)
Indented parts near ultrasonic mixers
7
Using a clean lint-free gauze pad, wipe the inner surfaces of the incubator bath.
8
Wipe the indented parts near the ultrasonic mixers ( B ) with a cotton swab.
u
For details, see To clean the surface of the ultrasonic mixer (c 701 / c 702 modules)
NOTICE
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 23-22 Cleaning the photometer windows ( c 701 / c 702 modules)
Damage to the photometer windows r Do not scratch the photometer windows when cleaning. r Use only gauze pads immersed in deionized water.
717
23 Maintenance of photometric modules
Monthly maintenance
A cobas® 8000 modular analyzer series
9 Carefully wipe the photometer windows using a clean lint-free gauze pad (or a cotton swab) moistened with deionized water.
A
A Filter removal tool
Figure 23-23 Removing the two drain filters ( c 701 / c 702 modules)
10
Remove the drain filters of the incubator bath using the filter removal tool ( A ).
The modules are equipped with 2 drain filters. Grasp the filters by their handle and pull the filters out.
11 Clean and rinse the filters with deionized water and return them to their place.
12 Check that the drain filters are correctly installed.
Continue with the following procedure: u
To reinstall reaction parts and to terminate Incubator Bath Cleaning mode (c 502 module) (p. 722).
s p To reinstall reaction parts and to terminate Incubator Bath Cleaning mode
(c 701 / c 702 modules)
1 Insert all segments of reaction cells.
2 Rotate the reaction disk by hand. Check that the bottom of the cells do not touch the incubator drain filters.
3 Reinstall the cell covers and the cell rinse units.
4 Close the top cover of the module.
5 Press the F1 push button behind the front doors to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water again. Then Ecotergent is added to the water. Afterwards the instrument returns to Standby.
Roche Diagnostics
718 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F
23 Maintenance of photometric modules
Monthly maintenance
6 Perform maintenance item (7) Wash Reaction Parts and then perform maintenance item (4) Cell Blank Measurement to verify the integrity of the reaction cells.
u
For detailed instructions, see:
To wash the reaction system (p. 702)
To perform a cell blank measurement (p. 703)
s p To put the module into Incubator Bath Cleaning mode (c 502 modules)
1
Choose Overview > Reagent Overview .
2
Check that the remaining volume of Ecotergent on each module is sufficient
(> 4 mL). If necessary, load a new detergent container. u
For instructions on how to replace the detergent container, see:
To replace the Ecotergent container (p. 393).
3
Select one of these statuses for this procedure: o
Recommended and described here: Incubator Bath Cleaning mode (incubator water is automatically drained and refilled after cleaning). Choose this mode if you want to clean the incubator bath at the same time.
o
Power Off (all mechanical parts can be moved by hand) u
See
Option 1: Cleaning the incubator bath with the instrument powered off (p. 723).
o
If only reaction cells must be replaced, choose Change Reaction Cell mode
(reaction disk can be rotated by hand). Follow the next steps analogous to
Incubator Bath Cleaning mode. u
After removing the reaction cells, follow the procedure:
Option 2: Attaching reaction cells (without cleaning the incubator bath) (p. 724).
4
Ensure the instrument or the module is in Standby (by masking the module).
5
Choose Utility > Maintenance > (10) Incubator Bath Cleaning .
6
Select the desired module and choose Execute .
A confirmation window opens.
As long as the Continue button is inactive (displayed gray), the water is drained from the incubator bath.
7
As soon as the Continue button is active (black), start cleaning following the next procedure.
q Wait until cleaning is completed
Do NOT choose Continue until cleaning of the incubator bath is completed!
s
Roche Diagnostics
Operator’s Manual · 4.2.1
719
23 Maintenance of photometric modules
Monthly maintenance
F cobas® 8000 modular analyzer series p To remove reaction cells and to clean the incubator bath (c 502 module)
1
Open the top cover of the module.
A B B
A Cell rinse unit
Figure 23-24 Removing the cell covers
2 Lift up or remove all cell covers (
3 Remove the cell rinse unit.
B Cell covers
A B C
Roche Diagnostics
720
A Retaining nut
B Reaction disk
Figure 23-25
C Indented parts near ultrasonic mixers
Dismounting the reaction disk ( c 502 module)
4 Loosen the retaining nut (
) and remove the complete reaction disk (
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
5 If the reaction cells are to be used again, be careful not to touch their surfaces.
Otherwise remove the reaction cells from the reaction disk.
6 Discard used reaction cells.
If only reaction cells must be replaced (without cleaning the incubator bath), continue with the following procedure: u
To attach reaction cells (without cleaning the incubator bath) (p. 724).
7 Using a clean lint-free gauze pad, wipe the inner surfaces of the incubator bath.
8
Wipe the indented parts near the ultrasonic mixers ( C ) with a cotton swab.
u
For details, see To clean the surface of the ultrasonic mixer (c 701 / c 702 modules)
NOTICE
Figure 23-26 Cleaning the photometer windows ( c 502 module)
Damage to the photometer windows r Do not scratch the photometer windows when cleaning. r Use only gauze pads immersed in deionized water.
Roche Diagnostics
Operator’s Manual · 4.2.1
721
23 Maintenance of photometric modules
Monthly maintenance cobas® 8000 modular analyzer series
9 Carefully wipe the photometer windows using a clean lint-free gauze pad (or a cotton swab) moistened with deionized water.
A
A
A Filter removal tool
Figure 23-27 Removing the drain filter ( c 502 module)
10 Remove the drain filter of the incubator bath using the filter removal tool (
Grasp the filter by its handle and pull it out.
11 Clean and rinse the filter with deionized water and return it to its place.
12 Check that the drain filters are correctly installed.
Continue with the next procedure.
s p To reinstall reaction parts and to terminate Incubator Bath Cleaning mode
(c 502 module)
1 Insert all segments of reaction cells.
2 Rotate the reaction disk by hand. Check that the bottom of the cells do not touch the incubator drain filters.
3 Reinstall the cell covers and the cell rinse units.
4 Close the top cover of the module.
5 Choose Continue in the Confirmation window to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water again. Then Ecotergent is added to the water. Afterwards the instrument returns to Standby.
6 Perform maintenance item (7) Wash Reaction Parts and then perform maintenance item (4) Cell Blank Measurement to verify the integrity of the reaction cells.
u
For detailed instructions, see:
To wash the reaction system (p. 702)
To perform a cell blank measurement (p. 703)
s
Roche Diagnostics
722 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
Option 1: Cleaning the incubator bath with the instrument powered off
As an alternative to the Incubator Bath Cleaning mode, you can also clean the incubator bath while the instrument is powered off.
F[ p To clean the incubator bath with the instrument powered off
1
Turn the tap to the DRAIN position and drain the incubator bath.
For c 701 / c 702 modules: The tap is located behind the front doors.
A
F
A Tap behind front doors of the c 701 / c 702 modules
Figure 23-28 Tap for manually draining the incubator bath
For c 502 modules: The tap is located at the rear of the module.
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Tap at the rear of the c 502 module
Figure 23-29 Tap for manually draining the incubator bath
723
23 Maintenance of photometric modules
Monthly maintenance cobas® 8000 modular analyzer series q Do not let all the water drain. Leave a small amount of water to just cover the bottom of the incubator bath.
2 To stop draining, turn the tap back to its OPERATION position.
3 Clean the incubator bath following the procedures described before.
4 After cleaning, gradually pour about 500 mL of deionized water into the incubator bath.
5 Perform maintenance item (5) Incubation Water Exchange and (4) Cell Blank
Measurement before you resume routine operation.
s
Option 2: Attaching reaction cells (without cleaning the incubator bath)
If only reactions cells were replaced in Change Reaction Cell mode, perform the following procedure. It is assumed that the reaction cells were already removed from the reaction disk (see procedures before).
p To attach reaction cells (without cleaning the incubator bath)
1
Attach new reaction cells. Be careful not to touch the optical surfaces.
2
Return the cell covers and the cell rinse units.
3
Close the top cover.
4
To terminate Change Reaction Cell mode, choose Cancel Maintenance from the
Overview menu.
5
Perform maintenance item (1) Reset for the selected module.
6
Perform maintenance item (7) Wash Reaction Parts and then perform maintenance item (4) Cell Blank Measurement to verify the integrity of the reaction cells.
u
For detailed instructions, see:
To wash the reaction system (p. 702)
To perform a cell blank measurement (p. 703)
s
Roche Diagnostics
724 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
Cleaning the detergent aspiration filters
The detergent aspiration filters are attached to the tube end in the cell detergent containers behind the front doors. Check the filters each time you replace a detergent container and clean them at least once a month. Clogging of the filter will reduce the accuracy of detergent aspiration and will lead to insufficient cell cleaning.
This maintenance comprises the following procedures and maintenance items:
1.
To clean the detergent aspiration filters (p. 725)
2.
To perform a cell detergent prime (p. 726)
Operator time approximately 4 minutes per module
System time approximately 5:45 minutes for (9) Cell Detergent Prime
Materials required m
Deionized water m
Paper towel
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
p To clean the detergent aspiration filters
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the front doors of the module and take out the detergent containers.
F[
Roche Diagnostics
Operator’s Manual · 4.2.1
A CellCln 1
Figure 23-30
A B
B CellCln 2
Removing the detergent aspiration filters ( c 701 used as example)
725
23 Maintenance of photometric modules
Monthly maintenance cobas® 8000 modular analyzer series
3 Remove the tubing from the detergent containers and unscrew the filter from the tube end.
4 Clean and rinse the filter with deionized water.
A
CAUTION
A Correct
Figure 23-31 Inserting the detergent aspiration tube
5
Finally, screw the filter on the tube end and place it back into the container (
Incorrect results due to incorrect insertion of aspiration tube
If the aspiration tube is not inserted correctly, the detergent may not be dispensed properly. This may lead to incorrect results.
r Insert the aspiration tube into the container all the way until its end touches the bottom of the container.
r Do not bend the aspiration tube.
6
Replace the container.
7
Close the front doors.
8
If the module was masked, unmask it.
9
If you placed a new detergent container, reset the volume count. Choose Reagent
> Status > Reagent Volume Reset .
10
Perform maintenance item (9) Cell Detergent Prime .
s p To perform a cell detergent prime
1 Choose Utility > Maintenance > (9) Cell Detergent Prime .
2 Choose Select to open the Cell Detergent Prime window.
3 Select the desired module.
Roche Diagnostics
726 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Monthly maintenance
4 For c 701 / c 702 modules: No detergent must be selected. Both detergents are used automatically.
For c 502 modules: Select an option in the Detergent area to specify which line is to be primed.
Detergent 1 corresponds to CellCln 1 (basic).
Detergent 2 corresponds to CellCln 2 (acid).
5 Choose Execute .
The procedure is finished when the module returns to Standby.
s
Cleaning the filters behind front doors
Clean the filters at least once a month to prevent dust or dirt accumulation. Clogging of the filters may cause temperature rise and faulty temperature control of the instrument.
Operator time approximately 3 minutes per module
Materials required m
Paper towels m
Water for rinsing m
Vacuum cleaner
CAUTION p To clean the filters behind the front doors
1
Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2
Open the front doors.
Burns due to contact with the radiator behind the filter
You may get burned by touching the radiator. r Avoid touching the radiator when removing the filter.
Roche Diagnostics
Operator’s Manual · 4.2.1
727
23 Maintenance of photometric modules
Monthly maintenance
F[ cobas® 8000 modular analyzer series
F
A Filter of the cooling unit
Figure 23-32 Removing the filter ( c 701 / c 702 module)
A
B
A
Roche Diagnostics
728
C
A Power supply filter
B Filter of the cooling unit
Figure 23-33
C Filter of the circuit board rack
Cleaning the filters ( c 502 module)
3
Remove the filters by pulling them forward from the retaining brackets.
4
Vacuum the filters. If they are visibly contaminated, rinse them with water and blot dry with paper towels.
5
Reinstall the filters. To reinstall the filter of the cooling unit ( B ), first insert the
bottom of the filter. Then push the top of the filter into the brackets.
6
Close the front doors of the module.
7
If the module was masked, unmask it.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Quarterly maintenance
Quarterly maintenance
This section describes all maintenance actions for the photometric modules that must be performed at least once every three months.
u
This section discusses the following maintenance actions:
Cleaning the ultrasonic mixers (p. 729)
Cleaning the filter of the solenoid valve (p. 732)
Cleaning the ultrasonic mixers
Clean the ultrasonic mixers at least every three months. Contamination and precipitation on the surface of the ultrasonic mixers may cause inadequate mixing and thus lead to inaccurate results.
q Replacement of ultrasonic mixers
The ultrasonic output intensity is continually monitored during measurement. If the data alarm MIXLOW occurs frequently, replacement of the ultrasonic mixers is required.
Contact your service representative for replacement.
This maintenance comprises the following procedures and maintenance items:
1.
To clean the surface of the ultrasonic mixer (c 701 / c 702 modules) (p. 729)
2.
To clean the surface of the ultrasonic mixer (c 502 modules) (p. 731)
3.
To check the intensity of the ultrasonic output (p. 731)
Operator time approximately 5 minutes per module
System time approximately 2 minutes for draining the incubator bath approximately 18 minutes for refilling the incubator bath approximately 3 minutes for (9) Cuvette Mixing check
Materials required m
2% Ecotergent solution m
Deionized water m
Cotton swabs
Before performing this maintenance action, observe the following safety precautions: r
Electrical shock from electronic equipment (p. 27)
r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
F[ p To clean the surface of the ultrasonic mixer (c 701 / c 702 modules)
1 Ensure the instrument or the module is in Standby (by masking the module).
2 Choose Utility > Maintenance > (10) Incubator Bath Cleaning .
3 Select the desired module and choose Execute .
The water is drained from the incubator bath.
Roche Diagnostics
Operator’s Manual · 4.2.1
729
23 Maintenance of photometric modules
Quarterly maintenance cobas® 8000 modular analyzer series
4 Choose Maintenance Monitor .
5 Wait until Incubator Bath Cleaning (Wait) is displayed.
6 Open the top cover of the module.
7 Remove the cell covers above the ultrasonic mixers.
8 Remove the reaction cells near the ultrasonic mixers (at least three cell segments).
Do not to touch the surfaces of reaction cells.
Roche Diagnostics
730
A
A Ultrasonic mixer
Figure 23-34 Cleaning the surfaces of the ultrasonic mixers ( c 701 used as example)
9
Gently wipe the surface of the ultrasonic mixers with cotton swabs moistened with 2% Ecotergent solution.
Then wipe off the detergent with cotton swabs moistened with deionized water.
10
Return the removed sections of reaction cells.
11
Return the cell covers.
12
Close the top cover of the module.
13
Press the F1 push button behind the front doors to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water again. Then Ecotergent is added to the water. Afterwards the instrument returns to Standby.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F
23 Maintenance of photometric modules
Quarterly maintenance p To clean the surface of the ultrasonic mixer (c 502 modules)
1
Ensure the instrument or the module is in Standby (by masking the module).
2
Choose Utility > Maintenance > (10) Incubator Bath Cleaning .
3
Select the desired module and choose Execute .
The water is drained from the incubator bath.
A confirmation window opens.
As long as the Continue button is inactive (displayed gray), the water is drained from the incubator bath.
4
As soon as the Continue button is active (black), start cleaning following the next steps.
q Wait until cleaning is completed
Do NOT choose Continue until cleaning of the incubator bath is completed!
5 Open the top cover of the module.
6 Remove the cell covers above the ultrasonic mixers.
7 Remove the reaction cells near the ultrasonic mixers (at least three cell segments).
Do not to touch the surfaces of reaction cells.
8 Gently wipe the surface of the ultrasonic mixers with cotton swabs moistened with 2% Ecotergent solution.
Then wipe off the detergent with cotton swabs moistened with deionized water.
9 Return the removed sections of reaction cells.
10 Return the cell covers.
11 Close the top cover of the module.
12 Choose Continue in the Confirmation window to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water again. Then Ecotergent is added to the water. Afterwards the instrument returns to Standby.
s p To check the intensity of the ultrasonic output
1
Choose Utility > Maintenance .
2
Select 2 Check from the left list.
3
Select (9) Cuvette Mixing .
4
Choose Select to open the Cuvette Mixing window.
5
Select a module, and verify the With Cell Wash check box is NOT selected.
Selecting this check box would rinse all reaction cells prior to the check.
6
Choose Execute to perform the intensity check.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
731
23 Maintenance of photometric modules
Quarterly maintenance
Cleaning the filter of the solenoid valve
cobas® 8000 modular analyzer series
The filter of the solenoid valve unit prevents dirt and dust being mixed into the unit when the valve opens up for air. Clean the filter and the inner walls once every three months.
Operator time approximately 3 minutes per c 701 / c 702 module
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
F[ p To clean the solenoid valve unit filter (c 701 / c 702 only)
1 Power off the complete instrument or the desired module.
2 Open the front doors of the module.
A
Roche Diagnostics
732
A Solenoid valve filter (sponge)
Figure 23-35 Cleaning the solenoid valve filter
3 Turn the filter cover to remove it and pull out the sponge.
o
If the sponge is dirty, wash it with tap water.
o
Then dry the sponge well and reinstall it.
4
Close the front doors of the module.
5
Power on the instrument or the module again.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Every six months maintenance
Every six months maintenance
This section describes the maintenance actions for the photometric modules that must be performed at least once every six months.
u
This section discusses the following maintenance actions:
Replacing the photometer lamp (p. 733)
Cleaning the water inlet filter (p. 739)
Replacing the photometer lamp
The reproducibility of measurement will decrease if the photometer lamp deteriorates. Replace the photometer lamp if the lamp has been used for more than six months (or 750 hours of power-on time) or if the photometer check value exceeds 14 000, whichever occurs first.
The total power-on time is displayed on the Cumulative Operation List report. To view this report, choose Print > Utility > Cumulative Operation List .
u
For more information please refer to the Online Help for that particular report.
For c 502 modules, we recommend combining this maintenance with the monthly cleaning of incubator bath.
This maintenance comprises the following procedures and maintenance items:
1.
To check the light intensity (p. 734)
2.
To remove the photometer lamp (c 701 / c 702 modules) (p. 734)
3.
To remove the photometer lamp (c 502 modules) (p. 735)
4.
To install a new photometer lamp (c 701 / c 702 and c 502 modules) (p. 738)
Operator time approximately 4 minutes per c 701 / c 702 module approximately 5 minutes per c 502 module
System time approximately 2:30 minutes for (3) Photometer Check approximately 30 minutes waiting for lamp cooling down approximately 30 minutes waiting for lamp stabilization approximately 15 minutes for (4) Cell Blank Measurement
Materials required m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Lint-free gauze pads m
Photometer lamp
Roche Diagnostics
Operator’s Manual · 4.2.1
733
23 Maintenance of photometric modules
Every six months maintenance
F[
WARNING cobas® 8000 modular analyzer series p To check the light intensity
1 Choose Utility > Maintenance > (3) Photometer Check .
2 Choose Select to open the Photometer Check window.
3 Select a module and choose Execute .
Water is injected from the rinsing mechanism into reaction cell no. 1 and the absorbance of the water is measured for each available wavelength.
4 Choose Print > History > Photometer Check .
5 Check the absorbance values in the current Photometer Check report.
If the current readings exceed 14 000 at 340 nm, check the following points and then replace the photometer lamp: o
Verify that the reaction cells, the incubator bath, and the photometric windows are free of contamination or bubbles.
o
Verify that the reaction cells are not scratched or cracked.
o
Verify that the reaction cells are at least half filled with water.
If the current readings are quite different from the previous ones, check if one of the above applies.
s p To remove the photometer lamp (c 701 / c 702 modules)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
r For c
502 only: Interrupt of operation due to interlock system (p. 50)
1
Choose Utility > Maintenance > (13) Change Photometer Lamp .
(Or: Power off the instrument or the module.)
2
Choose Select to open the Change Photometer Lamp window.
3
Select the desired module.
4
Choose Execute .
The power supply to the photometer lamp is cut off during the execution of
Change Photometer Lamp.
5
Wait about 30 minutes for the lamp and lamp housing to cool down.
Burns due to hot surface of the photometer lamp unit!
You may be burned if you touch any part of the photometer lamp unit.
r Wait about 30 minutes after turning off lamp power.
r Check that the photometer lamp unit has cooled down before replacing the lamp.
r Observe in particular the following safety label on the instrument:
6 Open the top cover of the module.
Roche Diagnostics
734 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
7 Open the right front door.
23 Maintenance of photometric modules
Every six months maintenance
A
Roche Diagnostics
Operator’s Manual · 4.2.1
B C D
A Photometer lamp cover
B Retaining screws
Figure 23-36
C
D
Cable clip
Connector
Removing the photometer lamp
8
Open the cover of the photometer lamp ( A ).
9
Loosen the lamp wires from the cable clip ( C ).
10
Disconnect the connector ( D ) of the lamp wires.
11
Loosen both retaining screws ( B ) and take out the photometer lamp. When the
screws become easy to turn, the lamp can be detached.
12
Remove the retaining screws (
s p To remove the photometer lamp (c 502 modules)
1
Choose Utility > Maintenance > (13) Change Photometer Lamp .
(Or: Power off the instrument or the module.)
2
Choose Select to open the Change Photometer Lamp window.
3
Select the desired module.
4
Choose Execute .
The power supply to the photometer lamp is cut off during the execution of
Change Photometer Lamp.
735
23 Maintenance of photometric modules
Every six months maintenance
WARNING cobas® 8000 modular analyzer series
5 Wait about 30 minutes for the lamp and lamp housing to cool down.
Burns due to hot surface of the photometer lamp unit!
You may be burned if you touch any part of the photometer lamp unit.
r Wait about 30 minutes after turning off lamp power.
r Check that the photometer lamp unit has cooled down before replacing the lamp.
r Observe in particular the following safety label on the instrument:
6
Open the top cover of the module.
7
Lift up or remove all cell covers.
8
Remove the cell rinse unit.
A
B q
A Retaining nut
Figure 23-37
B Reaction disk
Dismounting the reaction disk ( c 502 only)
9 Loosen the retaining nut (
) and remove the reaction disk (
cells from the module. Be careful not to touch the optical surfaces.
If the reaction cells are mounted when removing the reaction disk, water drops adhering to the outside of the reaction cells may drip onto components, causing an alarm to be issued.
Roche Diagnostics
736 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
A B
23 Maintenance of photometric modules
Every six months maintenance
C D E
A Photometer housing
B Retaining screws
Figure 23-38
C Cable clip
D Connector
E Connector cover
Removing the photometer lamp
10
Rotate the connector cover (
E ) and disconnect the connector ( D
) of the lamp wire.
11
Loosen the lamp wire from the cable clip (
).
12
Loosen both retaining screws ( B ) and take out the photometer lamp. When the
screws become easy to turn, the lamp can be detached.
13
Remove the retaining screws (
s
Roche Diagnostics
Operator’s Manual · 4.2.1
737
23 Maintenance of photometric modules
Every six months maintenance cobas® 8000 modular analyzer series p To install a new photometer lamp (c 701 / c 702 and c 502 modules)
1 Insert the retaining screws into the new photometer lamp.
2 Insert the new photometer lamp.
q Be careful not to touch the glass part of the new photometer lamp. If you do touch the glass, wipe it off with a gauze pad moistened with alcohol.
A B
Roche Diagnostics
738
A Pin hole
Figure 23-39
B Guide pin
Installing a new photometer lamp
3
Align the pin hole ( A ) in the lamp base with the guide pin ( B ) of the lamp housing
and tighten the two lamp retaining screws.
4 Connect the wire connector. Secure the lamp wires with the cable clip.
5 Reinstall all parts and close the covers of the module.
6 Choose Cancel Maintenance to terminate Change Photometer Lamp mode.
7 Wait about 30 minutes for the photometer lamp to stabilize.
8 Perform a cell blank measurement before you resume routine operation. This is necessary to compensate for a possible change in light intensity.
u
For instructions, see To perform a cell blank measurement (p. 703).
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
Every six months maintenance
Cleaning the water inlet filter
Clean the water inlet filter at least once every six months to prevent clogging of the water system. The water inlet filter is located at the rear of each module sample buffer.
Operator time approximately 5 minutes per module sample buffer
Materials required m
Water inlet filter (in case replacement is required) m
Paper towels m
Beaker or container, 500 mL m
Deionized water
CAUTION
Incorrect results due to clogged water filter
If the water inlet filter is clogged or the water hose is not reconnected to the inlet manifold correctly, it may lead to inaccurate measurement results or water leaks. r Clean the filter regularly.
r Reconnect the water inlet hose to the water inlet manifold correctly.
r
Observe in particular the following safety label on the instrument: R-6 (p. 45).
p To clean a water inlet filter
1 Turn off the external water supply.
2 Power off the complete instrument or the individual module to which the water inlet hose belongs.
3 Place a 500 mL beaker (or other appropriate container) beneath the water inlet manifold.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 23-40 Disconnecting the water inlet cap
739
23 Maintenance of photometric modules
Every six months maintenance cobas® 8000 modular analyzer series
4 Turn the water inlet cap counterclockwise and disconnect the water inlet cap.
B
A q
A Beaker
Figure 23-41 Disconnecting the joint
B Water inlet filter
5 Place the hose in the beaker to prevent spilling of water.
6 Remove the water filter – either from the inlet cap or from the inlet manifold.
7 Clean the filter thoroughly with deionized water, then reinstall the filter.
If necessary, replace the water inlet filter.
After cleaning, tighten the inlet cap securely and make sure there is no water leakage.
8 Reconnect the water inlet hose to the inlet manifold.
9 Turn on external water supply.
10 Power on the instrument or module again, or continue performing other maintenance tasks.
s
Roche Diagnostics
740 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance
As needed maintenance
This section describes the maintenance actions for the photometric modules that must be performed as needed and are not subject to a regular schedule.
u
This section discusses the following maintenance actions:
Unclogging cell rinse nozzles (p. 741)
Replacing nozzle tips on cell rinse nozzles (p. 743)
Draining the vacuum tank (p. 745)
Replacing the pipetter probes – elimination of clogging (p. 747)
Cleaning instrument surfaces (p. 756)
Cleaning the waste box for reagent caps (p. 756)
Cleaning the reagent pack gripper (p. 758)
Unclogging cell rinse nozzles
Perform this cleaning procedure if the cell rinse nozzles are clogged. In this case reaction solution may remain in the reaction cells or water may overflow from reaction cells.
Operator time approximately 3 minutes per module
System time approximately 0:45 minutes for (1) Reset
Materials required m
Cleaning wire of 0.5 mm diameter (stainless steel)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
Roche Diagnostics
Operator’s Manual · 4.2.1
741
23 Maintenance of photometric modules
As needed maintenance
F[ cobas® 8000 modular analyzer series p To unclog the cell rinse nozzles
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
A B C
D
F
A Cell rinse unit 3
B Cell rinse unit 2
Figure 23-42
C
D
Cell rinse unit 1
Retaining screw
Cell rinse units ( c 701 module is shown as example)
A B
Roche Diagnostics
742
A Retaining screw
Figure 23-43 Cell rinse unit ( c 502)
B Cell rinse unit
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance
3 Loosen the retaining screw of one cell rinse unit and lift off the entire unit.
Figure 23-44 Unclogging the cell rinse nozzles with cleaning wire 0.5 mm
4 Insert the probe cleaning wire (stainless steel wire, 0.5 mm diameter) into the nozzle tips and run it through the nozzles.
5 Reattach the cell rinse unit.
6
for each of the remaining cell rinse units.
7 Close the top cover.
8 If the module was masked, unmask it.
s
Replacing nozzle tips on cell rinse nozzles
Replace the nozzle tips on the cell rinse nozzles if they are worn. The replacement cycle is typically one to two years depending on conditions of use.
Replace a nozzle tip if its corner or bottom is worn so that water remains in the reaction cell.
q Nozzle tips can only be replaced on c 701 / c 702 modules
For cobas c 502 modules, the replacement of nozzle tips can only be performed by operators who received a special training for extended maintenance tasks.
Operator time approximately 4 minutes per module
System time approximately 2:00 minutes for (4) Probe Check approximately 1:30 minutes for (3) Mechanism Check (30 cycles)
Materials required m
Needle-nose pliers or radio pliers m
Nozzle tips
Roche Diagnostics
Operator’s Manual · 4.2.1
743
23 Maintenance of photometric modules
As needed maintenance
F[
3 cobas® 8000 modular analyzer series
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
2
1 p To replace the cell rinse nozzle tips (for c 701 / c 702 only)
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the top cover of the module.
3 Loosen the retaining screw of cell rinse unit 2 and lift off the entire unit.
Roche Diagnostics
744
A
A Nozzle tip
Figure 23-45 Replacing the cell rinse nozzle tips
4
Grip the nozzle tip (
) with pliers and pull it off. Be careful not to bend the nozzle.
C
B
A
C
D
E
A Nozzle tip
B Guide bars
C Reaction cell
Figure 23-46
D
E
Correct alignment
Incorrect alignment
Alignment of a nozzle tip in relation to reaction cells
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance
5
Attach a new nozzle tip ( A ) by hand and align it with the guide bars ( B
).
6 Attach the cell rinse unit.
7 Make sure the nozzle tip is correctly aligned with the reaction cell.
8 Close the top cover.
9 If the module was masked, unmask it.
s p To check the alignment of the nozzle tips (for c 701 / c 702 only)
1
Choose Utility > Maintenance > 2 Check .
2
Select (4) Probe Check and open the corresponding window.
3
Select Rinse 2 in the list box.
4
Choose Execute to start the Probe Check mode.
5
Visually check the alignment of the nozzle tips. The cell rinse unit can be moved to 3 positions by the F1 push button: o
Press F1 once to move the cell rinse unit to a position directly above the reaction cells.
o
Verify that the nozzle tips are aligned properly.
o
Press F1 again to move the cell rinse unit into the reaction cells.
o
Press F1 again to move the cell rinse unit to the upper position (home position) . o
To terminate the Probe Check mode, choose Cancel Maintenance .
6
Perform maintenance check (3) Mechanism Check (30 cycles) to check the movement of the mechanical components. u
See
To perform a Mechanism Check (p. 755).
If a mechanical problem is detected, the mechanism check will be interrupted and an instrument alarm will be issued.
s
Draining the vacuum tank
An alarm is issued (Liquid in vacuum tank) when there is water or waste solution in the vacuum tank. If this alarm appears, the vacuum tank must be drained. If this happens frequently, please contact your Roche service representative or technical support.
Operator time approximately 2 minutes per module
Materials required m
Beaker
Before performing this maintenance action, observe the following safety precautions: r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
Roche Diagnostics
Operator’s Manual · 4.2.1
745
23 Maintenance of photometric modules
As needed maintenance cobas® 8000 modular analyzer series p To drain the vacuum tank
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the front doors of the module.
3 Locate the drain tubes of the vacuum tank.
F[
A B B
A Vacuum tank (behind cover)
Figure 23-47 Draining the vacuum tank ( c 701 / c 702 module)
B Drain tubes of vacuum tank
F
A
Roche Diagnostics
746
A Drain tube of vacuum tank
Figure 23-48 Draining the vacuum tank ( c 502 module)
4 Detach the upper cap of the drain tube(s).
5 Drain the waste solution into a beaker.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance
6 Reattach the cap to secure the drain tube(s).
7 Close the front doors of the module.
8 If the module was masked, unmask it.
s
Replacing the pipetter probes – elimination of clogging
It is necessary to detach the probes to clean them inside, eliminate clogging, as well as for replacement. Replace a pipetter probe when it is bent or otherwise damaged.
This maintenance comprises the following procedures and maintenance items:
1.
To perform a sample probe wash (p. 747)
2.
Replacing the pipetter probes (c 701 / c 702 module) (p. 747)
q Probes can only be replaced on c 701 / c 702 modules
For cobas c 502 modules, the replacement of pipetter probes can only be performed by operators who received a special training for extended maintenance tasks.
Washing the sample probe
This procedure can be used to wash a clogged sample probe. p To perform a sample probe wash
1
Ensure the instrument is in Standby or the module is masked.
2
Choose Utility > Maintenance > (18) Sample Probe Wash .
3
Choose Select to open the Sample Probe Wash window.
4
Select the desired module and choose Execute .
The inside of the sample probe is washed with SmpCln 1 (basic wash). q If sample aspiration errors occur frequently or if an alarm for clogging of the sample probe occurs and is not reset after cleaning (maintenance item (18) Sample Probe
Wash), the sample probe must be detached and clogging must be eliminated.
If the sample probe is still clogged, continue with the next procedures.
s
Replacing the pipetter probes (c 701 / c 702 module)
This maintenance comprises the following procedures and maintenance items:
1.
To remove the plexiglass cover above the sample probes (p. 748)
2.
To detach a sample or reagent probe (p. 749)
3.
To eliminate clogging (p. 750)
4.
To reattach a sample or reagent probe (p. 751)
5.
To check the tubing system for leakage (p. 752)
6.
To check the horizontal alignment of a probe (p. 752)
7.
To perform an air purge and check the operation of the probe (p. 754)
8.
To perform a Mechanism Check (p. 755)
Roche Diagnostics
Operator’s Manual · 4.2.1
747
23 Maintenance of photometric modules
As needed maintenance cobas® 8000 modular analyzer series
Operator time approximately 4 minutes per pipetter probe
System time approximately 2:35 minutes for (4) Probe Check approximately 2:35 minutes for (6) Air Purge approximately 1:30 minutes for (3) Mechanism Check (30 cycles)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
Materials required m
Sample or reagent probes (in case replacement is required) m
Cleaning wire (stainless steel) 0.2 mm and 0.5 mm diameter m
Lint-free gauze pads m
Deionized water
F[ p To remove the plexiglass cover above the sample probes
1 Power off the complete instrument or the desired module.
2 Open the rear cover of the module.
A
Roche Diagnostics
748
A Plexiglass cover
Figure 23-49 Removing the plexiglass cover above the sample probes
3
Remove the plexiglass cover.
4
Continue with step
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F[
23 Maintenance of photometric modules
As needed maintenance p To detach a sample or reagent probe
1
Power off the instrument or the individual module. This ensures the liquid level sensor is not electrified.
2
Open the top cover of the module.
A B C D
Roche Diagnostics
Operator’s Manual · 4.2.1
q
A Arm cover
B Tubing
Figure 23-50
C Probe seal
D Connector of liquid level sensor
Removing the arm cover of a pipetter (the reagent probe is used as example)
3
Remove the arm cover ( A ) by pressing the arm cover releases on either side and
gently lift the cover. This exposes the wires and tubing.
When detaching the tubing, water will be flowing out of the tip of the pipetter probe. Be sure to work above the rinse station.
4
Unscrew the tubing ( B ) from the probe.
5
Locate the probe seal ( C ) either on the end of the tubing or in the retaining nut.
Take care not to drop and lose the probe seal.
6
Disconnect the connector of the liquid level sensor (
7
Lift the probe from the probe arm.
s
749
23 Maintenance of photometric modules
As needed maintenance cobas® 8000 modular analyzer series p To eliminate clogging
1 To eliminate clogging, use probe cleaning wire (stainless steel) with the following diameters: o
For sample probes (
A , figure 23-51): 0.2 mm diameter.
o
For reagent probes (
): 0.5 mm diameter.
A B
PP PP
A Sample probe
Figure 23-51 Unclogging probes
B Reagent probe
2 Insert the probe cleaning wire into the probe tip and run it through the probe.
3 Rinse the inside of the probe thoroughly with deionized water, then wipe the probe with clean lint-free gauze pads.
s
Roche Diagnostics
750 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F[
23 Maintenance of photometric modules
As needed maintenance p To reattach a sample or reagent probe
1
Insert the probe into the probe arm. The tab on the probe must slide into the holding slot on the pipetter arm to ensure proper alignment.
2
Reconnect the connector of the liquid level sensor.
A q
A Probe seal
Figure 23-52 Location of the probe seal, correct position of the tubing
(the reagent probe is used as example)
3
When reconnecting the tubing, make sure the probe seal is in place.
A probe seal, once pulled off, should not be reused since the edge will be deformed.
Each new probe contains a new seal.
4
Reattach the arm cover; the rear section first and then the front section.
5
Reattach the plexiglass cover above the sample probes.
6
Close all covers of the module.
7
Power on the instrument or the module again.
8
Go through the following procedures before you resume routine operation: o
To check the tubing system for leakage (p. 752)
o
To check the horizontal alignment of a probe (p. 752)
o
To perform an air purge and check the operation of the probe (p. 754)
o
To perform a Mechanism Check (p. 755)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
751
23 Maintenance of photometric modules
As needed maintenance
F[
CAUTION cobas® 8000 modular analyzer series p To check the tubing system for leakage
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
1 When initial operation is completed, power off the instrument or the individual module.
2 Open the top cover and the rear cover of the module. Remove the plexiglass cover.
3 Detach the arm covers of the pipetters again.
4 Visually check for any water leakage from the tubing connection inside and around the pipetter arms.
o
If there is a leak, wipe up the leaked water, and reattach the retaining nut. o
Then, start up the instrument and check again.
o
Reattach the arm covers.
5 Go through the following procedures before you resume routine operation: o
To check the horizontal alignment of a probe (p. 752)
o
To perform an air purge and check the operation of the probe (p. 754)
o
To perform a Mechanism Check (p. 755)
s p To check the horizontal alignment of a probe
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
1
Ensure all covers monitored by the interlock function are closed.
2
Choose Utility > Maintenance > 2 Check .
3
Select (4) Probe Check and open the corresponding window.
4
Select the module and the probe that needs to be checked.
Infection and injury due to contact with moving parts r During and at the completion of Probe Check mode, be careful not to come in contact with a moving probe.
Roche Diagnostics
752 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance
5 Choose Execute to start the Probe Check mode.
A
NOTICE
A F1 push button moves the probe horizontally
Figure 23-53 Push button F1 for (4) Probe Check
6 Press the push button F1 to move the probe horizontally.
7 Move the probe by repeated pressing of the F1 button.
8 Verify the positional accuracy at each stop. If the probe is not centered at each stop, carefully adjust it.
Damage to the instrument
The correct alignment of all probes is critical for proper functioning of the instrument.
Failure to correctly align all probes can result in damage to the instrument and/or incorrect test results.
r Do not bend a probe sharply. This can crimp the probe, which must then be replaced.
r We recommend that you contact your local Roche service representative or technical support.
9 If necessary, firmly hold the pipetter arm and gently bend the probe over its entire length in an arc to manually adjust the position.
10 To terminate Probe Check mode, choose Cancel Maintenance from the
Overview menu.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
753
23 Maintenance of photometric modules
As needed maintenance cobas® 8000 modular analyzer series p To perform an air purge and check the operation of the probe
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
1
Choose Utility > Maintenance > (6) Air Purge .
2
Choose Select to open the Air Purge window.
Roche Diagnostics
754
Figure 23-54 Air Purge window
3
Select the desired module.
4
In the Syringe area, select the syringe to be purged of air (or all syringes).
5
Choose Execute to initiate the air purge.
The air purge will be performed with the corresponding pipetter. At the rinse station, water as well as any air which may have become trapped are discharged.
6
With all interlock covers closed, visually check that water is dispensed from the tip of the probe in a straight flow.
If the flow is not straight, the probe may be clogged.
u
See
Replacing the pipetter probes – elimination of clogging (p. 747)
Now continue with the mechanism check.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance p To perform a Mechanism Check
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
1
Choose Utility > Maintenance > 2 Check .
2
Select (3) Mechanism Check .
3
Choose Select to open the Mechanism Check window.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 23-55 Mechanism check window
4
To select only particular modules, clear the SU check box and select the Limit
Cycles option.
5
Enter 10 in the Cycles text box and choose Execute .
All mechanisms of the selected module will operate.
6
Check to make sure the following conditions are maintained: o
The probes descend into the center of the reaction cells.
o
The probes do not contact any other parts.
o
At the rinse stations, the outside of each probe is rinsed with water.
After the mechanism check, the instrument returns to Standby. If an error is detected, an instrument alarm will be issued.
s
755
23 Maintenance of photometric modules
As needed maintenance
Cleaning instrument surfaces
cobas® 8000 modular analyzer series
Spills on the instrument surface could be biohazardous and damage the surface.
Clean up all spills immediately. Use this procedure to ensure that surfaces on all modules are clean.
Materials required m
Disposable cloth or paper towels m
Laboratory disinfectant (no bleach)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Interrupt of operation due to interlock system (p. 50)
NOTICE Damage to instrument surfaces r Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
p To clean instrument surfaces
1
Power off the complete instrument or the desired module.
Or: Ensure the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until it is in
Standby.
2
Clean the module surfaces using a cloth or paper towel moistened with disinfectant.
Clean up all spills immediately. Ensure that all surfaces are clean.
3
Unmask the module if it was masked.
s
Cleaning the waste box for reagent caps
Clean the entire cap waste box if reagent splashes adhere its surface.
Operator time approximately 4 minutes per c 702 module
Materials required m
Disposable cloth or paper towels
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
Roche Diagnostics
756 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
F
23 Maintenance of photometric modules
As needed maintenance p To clean the cap waste box (c 702 only)
1
Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2
Choose Overview > Reagent Manager Overview .
3
Make sure that there are no reagent packs in the buffer rotor.
u
If the buffer rotor is not empty, follow one of the procedures:
To manually control reagent packs on the buffer rotor (p. 370)
To unload reagent packs from the reagent manager buffer rotor (p. 376)
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A Cap waste box
Figure 23-56 Unloading the cap waste box
4 Take out the cap waste box from the compartment. Empty the box if necessary.
5 Rinse the cap waste box completely with tap water.
6 Dry the box with paper towels.
7 Return the box back in place.
8 On the Reagent Manager Overview window, choose Waste Box Reset to reset the cap counter to zero.
9 Unmask the module if it was masked.
s
757
23 Maintenance of photometric modules
As needed maintenance
Cleaning the reagent pack gripper
cobas® 8000 modular analyzer series
Clean the bottom side of the gripper if reagent splashes are found on the surface during the weekly check.
Operator time approximately 5 minutes per c 702 module
Materials required m
Cotton swabs m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
F p To clean the bottom side of the reagent pack gripper (c 702 only)
1
Select one of these statuses, which both allow to move the reagent gripper to a better accessible position: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ;).
u
See
To put a module in Manual Cleaning mode (p. 592)
3 Choose Maintenance Monitor to check that the module is in Manual Cleaning mode.
4 Open the top cover.
5 Move the reagent gripper with your hand to a better accessible position.
Roche Diagnostics
758
A
A Bottom side of reagent gripper
Figure 23-57 Cleaning the bottom side of the reagent gripper
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 23 Maintenance of photometric modules
As needed maintenance q
6 Clean the bottom side of the reagent gripper thoroughly with cotton swabs moistened with deionized water.
7 Manually move the gripper either to the leftmost or the rightmost position of the module.
If the gripper is not moved to the leftmost or rightmost position, the module will not resume operation and an alarm will be issued.
8 Close the top cover.
9 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
Additionally perform a reagent registration via Reagent > Setting > Reagent
Registration .
u
To terminate Manual Cleaning mode (p. 593)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
759
23 Maintenance of photometric modules
As needed maintenance cobas® 8000 modular analyzer series
Roche Diagnostics
760 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
24 Maintenance of cobas e 602 module
Maintenance of cobas e 602 module
24
This chapter describes the maintenance actions required for correct and efficient running of the e 602 module. The schedule contains all required periodic maintenance actions (daily, weekly, quarterly…) as well as maintenance actions that are performed as needed.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
24
Cleaning ProCell/CleanCell nozzles and replace reservoirs ................................. 768
Cleaning ProCell/CleanCell stand and aspiration tubes........................................ 789
761
24 Maintenance of cobas e 602 module
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
762 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Maintenance schedule for the cobas e 602 module
Maintenance schedule for the cobas e 602 module
The following table lists all maintenance actions required for the e 602 module:
Procedure
Daily
Weekly
Cleaning ProCell/CleanCell nozzles and replace reservoirs
Cleaning the mixing and separation stations
Every two weeks
Quarterly
Every six months
As needed
Table 24-1
Replacing the pinch valve tubings
Cleaning the water inlet filters
Cleaning ProCell/CleanCell stand and aspiration tubes
Cleaning the reagent disk and compartment
Cleaning the solid waste compartment
Finalization, always including reagent prime and reagent capping
Extended power OFF and ON procedures
Maintenance schedule - e 602 module
Instrument status
MC/PO
SB/MM
MC/PO
SB/MM/PO
MC/PO
MC/PO
SB
PO
PO
SB/MM/PO
SB/MM
SB/MM/PO
SB/MM
SB
SB/MM/PO
Instrument status (mode)
CAUTION
PO
SB
MM
MC
Power Off (or module powered off on Utility > System Configuration > Module
Settings )
Standby mode
Module Masked ( Start > Masking > Module Masking ), puts single modules in a status equal to Standby
Manual Cleaning mode u
For more information, see: Instrument statuses for maintenance (p. 590).
Incorrect results or damage to the instrument due to non-compliance of maintenance intervals
The intervals for maintenance and checkup recommended in this document are independent of the system operation time unless otherwise noted (e.g., maintenance actions which are based on test count or time). If the intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
r Observe the maintenance intervals stated in this document.
u
For information about intervals based on test count or time, see:
Periodic replacement of parts (p. 629).
u
For information on scheduling maintenance tasks, see:
Roche Diagnostics
Operator’s Manual · 4.2.1
763
24 Maintenance of cobas e 602 module
Daily maintenance
Daily maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the e 602 module that must be performed every day.
Cleaning probes and sippers
Clean the outside of the reagent probe, sample probe, sipper probes, and Pre-wash sippers to remove residual solution and precipitation. Impurities on the sample probe may cause problems and affect results. After cleaning the probe, its discharge and operation should be checked. When cleaning, take care not to bend or damage the probes or sippers.
Operator time approximately 5 minutes
Materials required m
Lint-free gauze pads m
Deionized water m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Paper towel
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
NOTICE p To clean probes and sippers
1 Select one of these statuses, which both allow movement of the pipetter probes to positions that leave the rinse stations easily accessible: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2
Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ; see
To put a module in Manual Cleaning mode (p. 592)).
Wait until the probes on the selected modules moved to their cleaning positions.
3
Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
4
Open the top cover of the module.
Damage to instrument surfaces r Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
Roche Diagnostics
764 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
NOTICE
24 Maintenance of cobas e 602 module
Daily maintenance
Damage to the probes r Do not bend or damage the lower end of the probes during cleaning. Move the arm gently. Do not move it up or down.
r Use a new lint-free gauze pad for each probe to prevent cross contamination.
r Clean the sample probe with deionized water first. Only if the sample probe still appears dirty, use alcohol followed by deionized water.
Figure 24-1 Cleaning the outside of the sample probe
Roche Diagnostics
Operator’s Manual · 4.2.1
765
24 Maintenance of cobas e 602 module
Daily maintenance cobas® 8000 modular analyzer series
5 Wipe the outside of the sample probe – from top to bottom – with a gauze pad moistened with deionized water.
If the probe still appears dirty, wipe the outer surface with a lint-free gauze pad moistened with alcohol. Immediately afterwards use a gauze pad moistened with deionized water.
A
Roche Diagnostics
766
B
C
A Reagent probe
B Sipper probes for measuring channels
C Pre-wash probes
Figure 24-2 Cleaning the outside of the probes and sippers
6 Place a paper towel underneath the reagent probe to ensure no alcohol drops into the module.
7
Clean the outside of the reagent probe ( A ), the Pre-wash probes ( C ), and the sipper probes ( B
):
Wipe the probes – from top to bottom – with lint-free gauze pads moistened with alcohol, followed by gauze pads moistened with deionized water.
8 Remove the paper towel from the module.
9 Close top cover and lock it with the key.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Daily maintenance
10 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned. u
To terminate Manual Cleaning mode (p. 593)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
767
24 Maintenance of cobas e 602 module
Weekly maintenance
Weekly maintenance
cobas® 8000 modular analyzer series
This section describes all maintenance actions for the e 602 module that must be performed at least once a week.
u
This section discusses the following maintenance actions:
Cleaning ProCell/CleanCell nozzles and replace reservoirs (p. 768)
Cleaning the mixing and separation stations (p. 773)
Cleaning the incubator (p. 775)
Cleaning the microbead mixer (p. 777)
Cleaning the rinse stations (p. 779)
Cleaning ProCell/CleanCell nozzles and replace reservoirs
As ProCell dries, crystals are formed. To prevent problems, the ProCell/CleanCell filling nozzles and electrodes must be cleaned and the reservoirs must be replaced regularly. This maintenance is divided into several procedures and must be performed in the specified order: o
Procedure 1 - To empty ProCell/CleanCell reservoirs
o
Procedure 2 - To clean nozzles and electrodes
o
Procedure 3 - To replace ProCell/CleanCell reservoirs
o
Procedure 4 - To perform a reagent prime
Operator time approximately 8 minutes
System time approximately 15 minutes
Materials required m
Cotton swabs m
Deionized water m
2 ProCell/CleanCell reservoirs
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
p Procedure 1 - To empty ProCell/CleanCell reservoirs
1 Choose Utility > Maintenance > (32) Empty PC/CC Reservoir .
2 Choose Select to display the Empty PC/CC Reservoir window.
3 Select the desired module and deselect all other modules.
4 Choose Execute . The PC/CC reservoirs are emptied.
After the procedure has been completed, the module goes into Standby.
s
Roche Diagnostics
768 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance p Procedure 2 - To clean nozzles and electrodes
1 Ensure the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until it is in
Standby.
2 Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
3 Open the top cover.
A B
NOTICE
C
A Sipper probe
B Black handle
C Unit with PC/CC filling nozzles and electrodes
Figure 24-3 Pull up the ProCell/CleanCell filling nozzles and electrodes
Damage to the sipper probes r Do not bend or damage the lower end of the sipper probes during cleaning. Move the arm gently. Do not move it up or down.
r Do not bend the electrodes for LLD inside the reservoir. If they are bent, contact technical support.
4 Manually move the sipper probes (
Roche Diagnostics
Operator’s Manual · 4.2.1
769
24 Maintenance of cobas e 602 module
Weekly maintenance cobas® 8000 modular analyzer series
5 Use the black handle (
B ) to gently pull up the PC/CC filling unit ( C ) to the stop/hold position (see figure 24-3).
A B
A Reservoir filling nozzle
Figure 24-4
B Electrodes
Cleaning the filling nozzles and electrodes
6 Clean the ProCell/CleanCell reservoir filling nozzle (
wiping them with a cotton swab moistened in deionized water.
s
Roche Diagnostics
770 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance p Procedure 3 - To replace ProCell/CleanCell reservoirs
1 Carefully remove the ProCell/CleanCell reservoirs (
) (upward /left direction) making sure the electrodes are not bent.
A
A ProCell/CleanCell reservoirs
Figure 24-5 Cleaning ProCell/CleanCell reservoirs
2
Clean the inside of the reservoir positions by wiping them with a cotton swab moistened in deionized water.
3
Place new reservoirs in the reservoir positions and push the sipper nozzle unit back into place.
4
Close the top cover and lock it with the key.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
771
24 Maintenance of cobas e 602 module
Weekly maintenance cobas® 8000 modular analyzer series p Procedure 4 - To perform a reagent prime
1 Choose Utility > Maintenance > (8) Reagent Prime .
Roche Diagnostics
772 q
Figure 24-6 Reagent Prime window
2 Select the desired e 602 module and deselect all other modules.
3 Select the Reagent option in the e 602 Prime Item area ( reagent refers to ProCell and CleanCell).
4 Enter 1 in the Cycles text box.
5 Choose Execute to start reagent priming.
6 Wait until the reagent prime is completed and the instrument enters Standby mode.
If, after maintenance, the instrument will be powered off or remain in Standby for an extended period of time, a finalization must be performed.
If further samples are to be processed, finalization is not necessary.
u
See
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance
Cleaning the mixing and separation stations
Spills on the mixing stations and the separation stations in the Pre-wash area can cause gripper movement alarms.
Operator time approximately 5 minutes
Materials required m
Cotton swabs m
Lint-free gauze pads m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Damage to the e 602 module due to the use of acid or alkaline solutions for cleaning
NOTICE p To clean the mixing and separation stations
1
Select one of these statuses: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2 Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ; see
To put a module in Manual Cleaning mode (p. 592)).
Wait until the probes on the selected modules moved to their cleaning positions.
3 Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
4 Open the top cover of the module.
Damage to the probes r Do not bend or damage the lower end of the sipper and dispenser probes during cleaning.
Roche Diagnostics
Operator’s Manual · 4.2.1
773
24 Maintenance of cobas e 602 module
Weekly maintenance cobas® 8000 modular analyzer series
A B
A Separation stations
Figure 24-7
B Vortex mixing station (Pre-wash area)
Mixing stations and separation stations
5 6
C
C Vortex mixing station (consumables area)
7
Figure 24-8 Example of the cleaning procedure for all mixing and separation stations
5 Clean the surface of all mixing stations and separation stations with lint-free gauze pads moistened with deionized water. If they appear dirty, scrub them gently with the moistened gauze pads.
6 Wet cotton swabs with deionized water and swab the openings on the mixing stations and the separation stations.
7 Dry the mixing station and the separation stations with dry, lint-free gauze pads and cotton swabs after cleaning.
q Ensure that the surface and the openings of the mixing stations and the separation stations are dry and not clogged, otherwise the gripper may experience problems when operation is resumed.
8 Close the cover and lock it with the key.
9 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
Mechanical parts on the selected module move to their standby positions.
s
Roche Diagnostics
774 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance
Cleaning the incubator
Spills on the incubator can cause gripper movement alarms.
Operator time approximately 10 minutes
Materials required m
Lint-free gauze pads m
Cotton swabs m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Damage to the e 602 module due to the use of acid or alkaline solutions for cleaning
p To clean the incubator
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
3 Open the top cover.
4 Move the gripper manually, if necessary, to allow the incubator cover to be removed.
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Incubator cover
Figure 24-9 Cleaning the incubator cover
5
Remove the cover of the incubator.
775
24 Maintenance of cobas e 602 module
Weekly maintenance cobas® 8000 modular analyzer series
6 Clean the incubator cover with lint-free gauze pads moistened with deionized water. If the cover appears dirty, scrub them gently with the moistened gauze pads.
Figure 24-10 Cleaning the incubator
7
Clean the top of the incubator with lint-free gauze pads moistened with deionized water. If the incubator appears dirty, scrub them gently with the moistened gauze pads.
Roche Diagnostics
776
Figure 24-11 Cleaning the incubator positions
8 Wet cotton swabs with deionized water and swab each of the 54 positions on the incubator.
9 Dry the incubator with dry, lint-free gauze pads and cotton swabs after cleaning.
q Ensure that the incubator and its positions are dry and not clogged, otherwise the gripper may experience problems when operation is resumed.
10 Return the incubator cover.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance
11 Close the top cover and lock it with the key.
12 If the module was masked, unmask it.
13 Perform maintenance item (1) Reset if you moved the gripper manually.
s
Cleaning the microbead mixer
Impurities on the microbead mixer may cause problems and lead to incorrect results.
Operator time approximately 2 minutes
Materials required m
Lint-free gauze pads m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Deionized water m
Small brush
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
NOTICE p To clean the microbead mixer
1 Select one of these statuses: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2
Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ; see
To put a module in Manual Cleaning mode (p. 592)).
Wait until the probes on the selected modules moved to their cleaning positions.
3
Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
4
Open the top cover.
Damage to the microbead mixer r Do not bend the microbead mixer during cleaning.
r Look and make sure the microbead mixer is not bent.
Roche Diagnostics
Operator’s Manual · 4.2.1
777
24 Maintenance of cobas e 602 module
Weekly maintenance
A cobas® 8000 modular analyzer series
B
A Microbead mixer paddle
Figure 24-12
B Propeller blades
Cleaning the microbead mixer paddle
5
Very carefully wipe the microbead mixer paddle ( A ) with a lint-free gauze pad
moistened with alcohol from top to bottom.
Roche Diagnostics
778
Figure 24-13 Cleaning the microbead mixer - propeller blades
6
Use a brush to clean the 4 propeller blades ( B ) with alcohol.
7
Repeat steps 5 and 6 using deionized water instead of alcohol.
8
Close the top cover and lock it with the key.
9
To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
The probes on the selected module move to their standby positions.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance
Cleaning the rinse stations
Contamination in the rinse stations for the Pre-wash probes, the reagent probe, the microbead mixer, and the sipper probes can cause problems.
Operator time approximately 5 minutes
Materials required m
Cotton swabs m
Alcohol (e.g., isopropyl alcohol or ethanol) m
2% Ecotergent solution m
Deionized water m
50 mL syringe with tubing attached
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
p To clean the rinse stations
1 Select one of these statuses, which both allow movement of the pipetter probes to positions that leave the rinse stations easily accessible: o
Manual Cleaning mode (described here) o
Power off (instrument or module)
2
Ensure the instrument or the module is in Standby (by masking the module).
Then put the module into Manual Cleaning mode ( Utility > Maintenance
> (11) Manual Cleaning ; see
To put a module in Manual Cleaning mode (p. 592)).
Wait until the probes on the selected modules moved to their cleaning positions.
3
Touch any screw at the rack loading area in order to discharge any static charge which may have built up on you.
Roche Diagnostics
Operator’s Manual · 4.2.1
779
24 Maintenance of cobas e 602 module
Weekly maintenance
4 Open the top cover.
cobas® 8000 modular analyzer series
A B
A Rinse station for microbead mixer
B Rinse station for Pre-wash probes
Figure 24-14 Rinse stations
C
C Rinse station for reagent probe
D Rinse station for sipper probes
D
5 Do not allow Ecotergent to drip into the reagent disk and the ProbeWash bottles.
Therefore, cover the openings with a paper towel.
6 8 10
Figure 24-15 Example of the cleaning procedure for all rinse stations
6 Clean the inside of each rinse station using a cotton swab moistened with alcohol, followed by a cotton swab moistened with deionized water.
7 Fill a syringe (with tubing attached) with 50 mL of 2% Ecotergent solution.
8 Inject the Ecotergent solution (empty the syringe) into the drain hole of the rinse station.
9 Fill a syringe with 50 mL of deionized water.
10 Inject the deionized water (empty the syringe) into the drain hole of the rinse station.
11
Repeat steps 6 10 for all rinse stations.
12 Close the top cover and lock it with the key.
Roche Diagnostics
780 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Weekly maintenance
13 To terminate Manual Cleaning mode, choose Cancel Maintenance from the
Overview menu. Afterwards perform maintenance item (1) Reset for the module concerned.
The probes on the selected module move to their standby positions.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
781
24 Maintenance of cobas e 602 module
Every two weeks maintenance
Every two weeks maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the e 602 module that must be performed at least once every two weeks.
Cleaning the liquid flow path
Contamination in the sipper system can cause problems. To keep the flow paths of the sippers clean and maintain the integrity of the measuring cell, clean the liquid flow path at least every two weeks or after 2500 to 3000 determinations per measuring channel, whichever comes first.
The number of tests performed is displayed on the Cumulative Operation List report.
u
For more information please refer to the Online Help for that particular report.
This maintenance comprises the following procedures and maintenance items:
1. To prepare liquid flow path cleaning
2. To perform liquid flow path cleaning
Operator time approximately 5 minutes
System time approximately 30 minutes
Materials required m
2 SysClean adapters (cups) m
SysClean solution
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
p To prepare liquid flow path cleaning
1
Open the top cover.
2
Take out both SysClean adapters.
Roche Diagnostics
782 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Every two weeks maintenance
3 Fill the SysClean adapters with SysClean solution to the lower line (approximately
9 mL/cup).
Roche Diagnostics
Operator’s Manual · 4.2.1
q
Figure 24-16 Placing the SysClean adapters
4
Carefully insert the filled SysClean adapters into the position located in front of the sipper unit to be cleaned.
If SysClean is spilled on the instrument, clean it up immediately with lint-free gauze pads moistened with deionized water.
5
Close the top cover.
s p To perform liquid flow path cleaning
1 Choose Utility > Maintenance > (26) Liquid Flow Cleaning .
2 Choose Select to display the Liquid Flow Cleaning window.
3 Select the desired e 602 module and deselect all other modules.
4 Select the Ch1,2 option.
5 Enter 1 in the Cycles text box and choose Execute .
Wait approximately 30 minutes until the instrument returns to Standby.
6 Open the top cover.
7 Remove both SysClean adapters.
8 Dispose of any remaining SysClean solution.
9 Rinse the SysClean adapters thoroughly with deionized water.
s
783
24 Maintenance of cobas e 602 module
Quarterly maintenance
Quarterly maintenance
cobas® 8000 modular analyzer series
In this section you will find the maintenance action for the e 602 module that must be performed at least once every three months.
Replacing the pinch valve tubings
Pinch valve tubings wear out in the course of time. To rule out the risk of defective tubings, replace the pinch valve tubings every 3 months or after measuring
25,000 tests per measuring channel.
The number of tests performed is displayed on the Cumulative Operation List report.
u
For more information please refer to the Online Help for that particular report.
This maintenance comprises the following procedures and maintenance items:
1. To replace pinch valve tubings
2. To perform sipper air purge
Operator time approximately 5 minutes
System time approximately 30 minutes
Materials required m
4 pinch valve tubings m
Lint-free gauze pads
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
Roche Diagnostics
784 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Quarterly maintenance p To replace pinch valve tubings
1 Perform maintenance item (25) MC Exchange before removing the tubes to avoid fluid dripping on the valves.
2 Power off the complete instrument or the desired module.
3 Open the middle door of the module.
A
B
C
WARNING
A Tube fitting
B Tubing
Figure 24-17
C Pinch valve
Replacing pinch valve tubings
Infection from samples
Liquid from the tubings and the acrylic block comes from the measuring cell and is potentially biohazardous.
r Wear gloves when removing the tubings. Wipe up all spills immediately.
4
Carefully remove (pull) all 4 pinch valve tubings ( B ) from the fittings ( A ).
5
Use a dry gauze pad to absorb liquid which drains from the acrylic block or from the tubings.
6
Take new pinch valve tubings and insert them through the pinch valves (
7
Carefully slide the ends of the tubing over each fitting (
Go through the following procedures before you resume routine operation: o
To perform sipper air purge (p. 786)
o
To perform MC preparation (p. 786)
s
Roche Diagnostics
Operator’s Manual · 4.2.1
785
24 Maintenance of cobas e 602 module
Quarterly maintenance cobas® 8000 modular analyzer series p To perform sipper air purge
1 Power on the instrument or the module.
2 After initialization is finished, choose Utility > Maintenance > (23) Sipper Air
Purge .
3 Choose Select to display the Sipper Air Purge window.
4 Select the desired e 602 module and deselect all other modules.
5 Enter 10 in the Cycles text box and choose Execute to initiate the sipper air purge.
While the air purge is executed, inspect the syringe to ensure that no air remains
probe.
s p To perform MC preparation
1
Choose Utility > Maintenance > (24) MC Preparation .
2
Choose Select to display the MC Preparation window.
3
Select the desired e 602 module and deselect all other modules.
4
Select Ch1,2 from the list box. If only one tube has been replaced, choose the corresponding measuring channel.
5
Enter 10 in the Cycles text box and choose Execute to initiate MC preparation.
Again, check for leaks at the fittings and on the tubings while the instrument is performing the maintenance function.
6
Close the middle door of the module.
s
Roche Diagnostics
786 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
Every six months maintenance
Every six months maintenance
This section describes the maintenance action for the immunologic module that must be performed at least once every six months.
Cleaning the water inlet filters
Clean the water inlet filters at least once every six months to prevent clogging of the water system. A water inlet filter is located at the rear of each module sample buffer.
Operator time approximately 5 minutes per module sample buffer
Materials required m
Water inlet filter (in case replacement is required) m
Paper towels m
Beaker or container, 500 mL m
Deionized water
CAUTION
Incorrect results due to clogged water filter
If the water inlet filter is clogged or the water hose is not reconnected to the inlet manifold correctly, it may lead to inaccurate measurement results or water leaks. r Clean the filter regularly.
r Reconnect the water inlet hose to the water inlet manifold correctly.
r
Observe in particular the following safety label on the instrument: R-6 (p. 46).
p To clean a water inlet filter
1 Turn off the external water supply.
2 Power off the complete instrument or the individual module to which the water inlet hose belongs.
3 Place a 500 mL beaker (or other appropriate container) beneath the water inlet manifold.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 24-18 Disconnecting the water inlet cap
787
24 Maintenance of cobas e 602 module
Every six months maintenance cobas® 8000 modular analyzer series
4 Turn the water inlet cap counterclockwise and disconnect the water inlet cap.
B
A q
A Beaker
Figure 24-19 Disconnecting the joint
B Water inlet filter
5 Place the hose in the beaker to prevent spilling of water.
6 Remove the water filter – either from the inlet cap or from the inlet manifold.
7 Clean the filter thoroughly with deionized water, then reinstall the filter.
If necessary, replace the water inlet filter.
8 Reconnect the water inlet hose to the inlet manifold.
Tighten the inlet cap securely and make sure there is no water leakage.
9 Turn on external water supply.
10 Power on the instrument or module again, or continue performing other maintenance tasks.
s
Roche Diagnostics
788 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance
As needed maintenance
This section describes the maintenance actions for the e 602 module that must be performed as needed and are not subject to a regular schedule.
u
This section discusses the following maintenance actions:
Cleaning ProCell/CleanCell stand and aspiration tubes (p. 789)
Cleaning the reagent disk and compartment (p. 793)
Cleaning the solid waste compartment (p. 796)
Extended power OFF and ON procedures (p. 801)
Cleaning instrument surfaces (p. 812)
Cleaning ProCell/CleanCell stand and aspiration tubes
Clean the stand for the ProCell and CleanCell bottles and the aspiration tubes if crystallization is observed.
This maintenance comprises the following procedures and maintenance items:
1. To clean ProCell/CleanCell stand and aspiration tubes
Operator time approximately 5 minutes
System time 15 minutes
Materials required m
Lint-free gauze pads m
ProCell/CleanCell bottle caps m
Paper towels m
Deionized water
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
Take extra care: CleanCell causes severe burns!
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
Roche Diagnostics
Operator’s Manual · 4.2.1
789
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series p To clean ProCell/CleanCell stand and aspiration tubes
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
2 Open the middle door of the module.
A
B
C
A Notch
Figure 24-20
B Aspiration tube C Filter
Replacing a ProCell/CleanCell bottle
3
Pull the aspiration tubes (
) up and to the left to secure them on their respective notches (
q Droplets of ProCell and CleanCell may trickle when ProCell and CleanCell bottles are removed. If this occurs, use paper towels or gauze pads to wipe up the liquid.
Roche Diagnostics
790
Figure 24-21 Removing the bottles
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance
4 Close the ProCell and CleanCell bottles with caps and take the bottles out from the module.
Figure 24-22 Cleaning the aspiration tubes
5
Wipe the aspiration tubes with lint-free gauze pads moistened with deionized water and then dry them with dry, lint-free gauze pads.
Roche Diagnostics
Operator’s Manual · 4.2.1
A
A ProCell and CleanCell stand
Figure 24-23 Cleaning the stand for ProCell and CleanCell bottles
6 Remove the ProCell and CleanCell stand (
7 Clean the stand with lint-free gauze pads moistened with deionized water, then dry it with dry gauze pads.
8 It may be necessary to clean the metal sheets at the bottom of the instrument. Use a lint-free gauze pad with water and dry afterwards.
791
24 Maintenance of cobas e 602 module
As needed maintenance
CAUTION cobas® 8000 modular analyzer series
9 Return the stand in the module.
Incorrect results due to misplaced ProCell/CleanCell bottles
ProCell and CleanCell bottles are different in shape to fit the keyed position of the bottle stand. This is done to ensure the correct positions. Measurements cannot be performed if the bottle stand is not present.
r Ensure the bottle stand is present before placing the ProCell and CleanCell bottles.
r To prevent evaporation, check that each bottle is closed correctly by the slider cap.
q
10 Return the ProCell and CleanCell reagent bottles to their original positions and remove the caps.
11 Lower the aspiration tubes into the bottles. Ensure that the bottles are closed by the slider caps.
12 Close the middle door of the module.
13 If the module was masked, unmask it.
After returning the ProCell and CleanCell bottles, it is important to perform a reagent prime and finalization to ensure there are no air bubbles in the fluid system.
If further samples are to be processed, finalization is not necessary.
u
See:
To perform a reagent prime (p. 792)
To perform finalization (p. 800).
s p To perform a reagent prime
1 Choose Utility > Maintenance > (8) Reagent Prime .
Roche Diagnostics
792
Figure 24-24 Reagent Prime window
2
Select the desired e 602 module and deselect all other modules.
3
Select the Reagent option in the e 602 Prime Item area.
4
Enter 1 in the Cycles text box.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance q
5 Choose Execute to start reagent priming.
Wait until the reagent prime is completed and the instrument enters Standby mode, before you continue.
If, after maintenance, the instrument will be powered off or remain in Standby for an extended period of time, finalization and reagent capping must be performed.
If further samples are to be processed, finalization and reagent capping are not necessary.
u
See:
To perform finalization (p. 800)
To perform reagent capping (p. 800).
s
Cleaning the reagent disk and compartment
Clean reagent spills as they occur. Clean the reagent disk as needed.
This maintenance comprises the following procedures and maintenance items:
2. To clean the reagent disk compartment
3. To clean and reinstall the reagent disk
Operator time approximately 10 minutes
Materials required m
Lint-free gauze pads m
Alcohol (e.g., isopropyl alcohol or ethanol) m
Deionized water m
Cloth or lint-free towels
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Fire and burns due to the use of alcohol (p. 581)
NOTICE p To clean the reagent disk
1
Ensure the instrument or the module is in Standby (by masking the module).
Damage to the microbead mixer r Do not bend the microbead mixer when cleaning the reagent disk compartment.
r Look and make sure the microbead mixer is not bent.
Roche Diagnostics
Operator’s Manual · 4.2.1
793
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series
Figure 24-25 Removing the cover from the reagent disk
2
Unlock and open the cover from the reagent disk.
3
Completely close the caps of all cobas e packs.
4
Remove all cobas e packs from the reagent disk and store them in a refrigerator
(see Instructions for Use for the on-board stability of reagents).
Roche Diagnostics
794
Figure 24-26 Removing the reagent disk
5 Loosen and remove the black thumbscrews.
6 Remove the empty reagent disk from the compartment.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance p To clean the reagent disk compartment
1 Wipe the reagent disk compartment with lint-free gauze pads moistened with deionized water.
q Do not scratch or smear the barcode reader window (
reading errors.
A
Roche Diagnostics
Operator’s Manual · 4.2.1
A Barcode reader window
Figure 24-27 Cleaning the reagent disk compartment
2 If the compartment still appears dirty, use lint-free gauze pads moistened with alcohol. Then clean it using lint-free gauze pads moistened with deionized water.
3 Dry the reagent disk compartment with a cloth or lint-free towels.
s p To clean and reinstall the reagent disk
1
Wipe the inside and outside of the reagent disk with lint-free gauze pads moistened with deionized water.
If the disk still appears dirty, use lint-free gauze pads moistened with alcohol to clean the disk. Then clean it using lint-free gauze pads moistened with deionized water.
2
Dry the reagent disk with a cloth or lint-free towels.
3
Return the reagent disk to the compartment. Make sure that the alignment pin on the center plate is aligned with the opening on the disk.
4
Reinstall and tighten the thumbscrews.
5
Return the cobas e packs to the reagent disk.
6
Replace and lock the reagent disk cover.
The caps of the cobas e packs are opened and the reagents are registered automatically.
7
Close the top cover of the module.
795
24 Maintenance of cobas e 602 module
As needed maintenance
8 Unmask the module if it was masked.
s cobas® 8000 modular analyzer series
Cleaning the solid waste compartment
Check the waste compartment when emptying the solid waste containers. If the compartment is dirty and requires cleaning, follow the procedures below.
Operator time approximately 5 minutes
Materials required m
Lint-free gauze pads m
Cloth or lint-free towels m
Laboratory disinfectant (no bleach) m
Deionized water m
WasteLiner
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
WARNING
Infection from waste solution and solid waste
Since waste solution contains patient samples, contact with waste solution and solid waste
(e.g., AssayCups, AssayTips) may result in infection. r Be sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection. r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
r Observe in particular the following safety labels on the instrument:
Roche Diagnostics
796 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance p To clean the solid waste compartment
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
A B
A Green status lamp
Figure 24-28
B
Opening the magazine drawer
Handle of the magazine drawer
2
Wait until the green status lamp (
A ) at the top of the drawer is ON, then pull out
the magazine drawer.
Roche Diagnostics
Operator’s Manual · 4.2.1
A B C D
A WasteLiner
B Solid waste containers
C Empty magazines
Figure 24-29
D
Cleaning the magazine drawer
Magazine waste compartment
3 Remove both WasteLiners (
A ) from the solid waste containers ( B
).
797
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series q
4 Remove the empty magazines (
) from the magazine waste compartment.
5 Wipe the inside and outside of the solid waste containers and the magazine waste compartment (
D ) with lint-free gauze pads moistened with disinfectant.
6 Wipe the inside and outside of the solid waste containers and the magazine waste compartment again, this time using lint-free gauze pads moistened with deionized water.
7 Dry the solid waste containers and the magazine waste compartment with a cloth or lint-free towels.
If the area surrounding the waste containers appears to be dirty, it should also be cleaned by the same procedure.
8 Place new WasteLiners into the waste containers.
9 Close the drawer, ensuring that it is fully closed.
A
B q
A Position 1 = Green button for left WasteLiner
B Position 2 = Green button for right WasteLiner
Figure 24-30 Updating the inventory after replacement
10
Open the transparent door at the front of the drawer.
11
Press the green button corresponding to the emptied container(s) to update the inventory. These buttons flash for a moment and then light green.
12
Close the door, ensuring that it is fully closed.
13
Unmask the module if it was masked.
o Ensure that the door at the front of the drawer is closed. Otherwise, the magazine lifter detects the open door the next time it operates and the instrument stops.
o The inventory is updated and displayed on the Reagent Overview window.
s
Roche Diagnostics
798 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Finalization
24 Maintenance of cobas e 602 module
As needed maintenance
Finalization allows the module to stand unused for several hours (for example, overnight). The e 602 module is primed with deionized water, the measuring channels are filled with ProCell, and the sipper probes are cleaned with deionized water.
Finalization is performed automatically after completion of measurement. The instrument status Post Operation is displayed during finalization. q Manual finalization
You must only initiate finalization manually if an analysis run was interrupted (by pressing the Stop button or due to an error) or if finalization did not complete (alarm is issued) and the instrument will stand unused for several hours.
Always start finalization in combination with reagent prime and reagent capping. Never perform finalization alone.
The finalization steps can be automated using a maintenance pipe.
u
See: Finalization pipe (after interruption of analysis) (p. 604)
Manual finalization requires the following steps:
1.
To perform a reagent prime (p. 799)
2.
To perform finalization (p. 800)
3.
To perform reagent capping (p. 800)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
p To perform a reagent prime
1 Ensure the instrument or the module is in Standby (by masking the module).
2 Choose Utility > Maintenance > (8) Reagent Prime .
Roche Diagnostics
Operator’s Manual · 4.2.1
799
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series
3 Choose Select to display the Reagent Prime window.
Roche Diagnostics
800
Figure 24-31 Reagent Prime window
4 Select the desired e 602 module.
5 Select the Reagent option in the e 602 Prime Item area.
6 Enter 1 in the Cycles text box.
7 Choose Execute to start reagent priming.
Wait until the reagent prime is finished and the instrument enters Standby, before you continue.
s p To perform finalization
1
Choose Utility > Maintenance > (31) Finalization .
2
Choose Select to display the Finalization window.
3
Select the desired e 602 module and deselect all other modules. The channels
Ch 1,2 are selected.
4
Choose Execute to start finalization.
After the procedure has been completed, the instrument goes into Standby.
s p To perform reagent capping
1 Choose Utility > Maintenance > (34) Reagent Capping .
2 Choose Select to display the Reagent Capping window.
3 Select the desired e 602 module.
4 Choose Execute to close all open caps of cobas e packs.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Extended power OFF and ON procedures
If the instrument is not used for an extended period of time, it is important to ensure that the instrument is properly prepared and that the correct shut down maintenance has been performed.
Time period (Days)
1 to 2
3 to 7
8 or more
Table 24-2
Power OFF procedure Power ON procedure
When the instrument was not in use for a period longer than
8 days, call technical support. The necessary procedure is performed by your technical support staff.
Extended power OFF procedures
Power OFF 1
24 Maintenance of cobas e 602 module
As needed maintenance
Use this power off procedure if the instrument will not be in use for 1 to 2 days (e.g., a weekend).
q Checks before powering off the instrument
If you use the Power Up Pipe function to be performed automatically at power up of the system, always check the following before powering off the instrument: o Make sure the Preventive Action check box on the Overview menu is selected.
o Check the remaining amount of the reagents required by the Power Up pipe.
u
See: Power Up Pipe function (p. 599).
u
For more information about powering off, see:
Powering off the instrument (p. 293).
p Power OFF 1
1
Press the orange Operation Power OFF button, located at the front of the core unit.
2
Turn off the external water supply.
3
Perform the instrument inspection, either now or before the next power-on. u
See
Instrument inspection (p. 294)
s
Power ON 1
The following procedure corresponds to
Power OFF 1 (p. 801). Use the following
Power ON Procedure if the instrument was unused for 1 to 2 days (for example, a weekend).
q The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering on.
u
See Recommended maintenance pipes (p. 603).
Before performing this maintenance action, observe the following safety precautions: r
Infection and injury due to contact with instrument mechanism (p. 581)
Roche Diagnostics
Operator’s Manual · 4.2.1
801
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series p To prepare e 602 modules for routine operation
1 Start up the instrument automatically or manually.
u
See
To automatically start up the instrument (p. 272)
To manually start up the instrument (p. 273)
2 Choose Utility > Maintenance > (36) System Air Purge (e602) .
Figure 24-32 System Air Purge window o
Select all e 602 modules.
o
Select the Ch1,2 option and enter 5 in the Cycles text box. o
Choose Execute to initiate the system air purge.
3 During system air purge, visually check that water is dispensed from the tip of the sample probe and the reagent probe in a straight flow.
If water is not dispensed in a straight flow, call technical support.
Roche Diagnostics
802 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance
4 After system air purge, open the middle door of the module.
A
B
A
C
A Check connectors for leakage
B Check for air bubbles inside
Figure 24-33
C Check bottom of syringe for leakage
Check syringe for leakage and air bubbles
5
Inspect the syringes to ensure that no air remains in the syringes and no leaks are visible at any of their fittings.
o
If leakage is found at a tube connector (
o
If there are air bubbles in the syringe ( B ), remove them by lightly tapping the
syringe with liquid flowing. If bubbles cannot be removed that way, call technical support.
o
If leakage is found at the bottom of the syringe ( C ), call technical support.
6
Close the middle door of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
803
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series
7 Choose Utility > Maintenance > (8) Reagent Prime .
Figure 24-34 Reagent Prime window o
Select the Pre-wash Sipper option in the e 602 Prime Item area. o
Enter 5 in the Cycles text box.
o
Choose Execute to start reagent priming.
o
During reagent prime, visually check that PreClean solution is dispensed from the Pre-wash dispenser in a straight flow. Otherwise, call technical support.
8
Choose Utility > Maintenance > (24) MC Preparation .
Roche Diagnostics
804
Figure 24-35 Reagent Prime window o
Select the Ch1,2 option and enter 5 in the Cycles text box.
o
Choose Execute to initiate MC preparation.
The e 602 modules are now ready for routine operation.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Power OFF 2
24 Maintenance of cobas e 602 module
As needed maintenance
Use the following procedure if the instrument will not be used for 3 to 7 days.
This maintenance comprises the following procedures and maintenance items:
1. To perform liquid flow path cleaning
2. To remove reagents and consumables
5. To perform sipper air purge
6. To perform daily and weekly maintenance items and to power OFF the instrument
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
r
Infection and injury due to contact with instrument mechanism (p. 581)
System time approximately 45 minutes q The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering off.
u
See Recommended maintenance pipes (p. 603).
u
For a detailed description of the following procedure, see:
Cleaning the liquid flow path (p. 782).
p To perform liquid flow path cleaning
1
Open the top cover of all e 602 modules.
2
Fill the SysClean adapter cups with SysClean solution to the lower line
(approximately 9 mL/cup).
3
Carefully insert the filled SysClean cups into the position located in front of the sipper unit.
4
Close the top covers.
5
Choose Utility > Maintenance > (26) Liquid Flow Cleaning .
6
Select all e 602 modules.
7
Select the Ch1,2 option.
8
Enter 1 in the Cycles text box and choose Execute .
q Ensure the instrument has returned to Standby mode before continuing.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
805
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series p To remove reagents and consumables
1 Remove the reagent disk cover and press the caps of each cobas e pack down to close them.
2 Remove all cobas e packs from the reagent disk(s). Refrigerate them in the same manner as unused cobas e packs. The cobas e packs can be used again.
3 Remove all magazines from the magazine lifter and the magazine waste. Ensure that no AssayTips or AssayCups are present on the module.
4 Choose Utility > Maintenance .
5 Select 2 Check from the left list.
6 Select (16) Magazine Exchange Check .
7 Enter 1 in the Cycles text box. A caution alarm is issued because there are no
AssayTips or AssayCups available.
8 Remove the WasteLiners and replace with new ones.
9 Remove the ProbeWash, ProCell, CleanCell and PreClean bottles. Replace them with new bottles filled with deionized water.
10 Remove the SysClean adapters from the instrument.
s p To perform reagent prime
1
Choose Utility > Maintenance > (8) Reagent Prime .
Roche Diagnostics
806
Figure 24-36 Reagent Prime window o
Select all e 602 modules.
o
Select the Reagent option in the e 602 Prime Item area. o
Enter 5 in the Cycles text box.
o
Choose Execute to start reagent priming.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance
2 Display the Reagent Prime window a second time.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 24-37 Reagent Prime window o
Select the Pre-wash Sipper option in the e 602 Prime Item area. o
Enter 5 in the Cycles text box.
o
Choose Execute to start reagent priming.
s p To empty PC/CC reservoirs
1 Choose Utility > Maintenance > (32) Empty PC/CC Reservoir .
2 Choose Select to display the corresponding window. Select all e 602 modules.
3 Choose Execute . The PC/CC reservoirs are emptied.
s p To perform sipper air purge
1
Choose Utility > Maintenance > (23) Sipper Air Purge .
2
Choose Select to display the corresponding window. Select all e 602 modules.
3
Enter 10 in the Cycles text box and choose Execute .
4
Remove the ProCell and CleanCell reservoir cups.
s
807
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series p To perform daily and weekly maintenance items and to power OFF the instrument
1 Perform all daily and weekly maintenance items excluding (8) Reagent Prime and (31) Finalization .
u
For more information, see:
2 Press the orange Operation Power OFF button at the front of the core unit.
3 Turn off the timer toggle switch, if necessary.
4 Turn off the external water supply.
5
Perform the instrument inspection, either now or before the next power-on.
u
See
Instrument inspection (p. 294)
s
Power ON 2
The following procedure corresponds to
Power OFF 2 (p. 805). Use the following
Power ON Procedure if the instrument was unused for 3 to 7 days.
This maintenance comprises the following procedures and maintenance items:
1. To reload consumables and start the instrument
2. To prepare e 602 modules for routine operation
q The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering on.
u
See Recommended maintenance pipes (p. 603).
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
r
Contamination of the environment due to inappropriate treatment of waste (p. 29)
Roche Diagnostics
808 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance p To reload consumables and start the instrument
1 Return the removed reagents to the instrument prior to power ON.
2 Discard the ProbeWash, ProCell, CleanCell and PreClean bottles filled with deionized water.
3 Put new ProbeWash, ProCell, CleanCell and PreClean bottles in place.
4 Refill magazine lifter and place new ProCell and CleanCell reservoir cups on the instrument.
5 Start up the instrument automatically or manually.
u
See
To automatically start up the instrument (p. 272)
To manually start up the instrument (p. 273)
6 Enter your operator ID and password to log on.
When initialization is completed, the analyzer goes into Standby.
q Update all consumables on the e 602 modules by pressing the corresponding green buttons.
7 Perform the following maintenance items in the specified order to prepare the instrument for routine operation.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
809
24 Maintenance of cobas e 602 module
As needed maintenance cobas® 8000 modular analyzer series p To prepare e 602 modules for routine operation
1 Choose Utility > Maintenance > (36) System Air Purge (e602) .
o
Choose Select to display the corresponding window. Select all e 602 modules.
o
Select the Ch1,2 option and enter 5 in the Cycles text box.
o
Choose Execute to initiate the system air purge.
2 During system air purge, visually check that water is dispensed from the tip of the sample probe and the reagent probe in a straight flow.
If water is not dispensed in a straight flow, call technical support.
3 After system air purge, open the middle door of the module.
A
B
A
C
A Check connectors for leakage
B Check for air bubbles inside
Figure 24-38
C Check bottom of syringe for leakage
Check syringe for leakage and air bubbles
4
Inspect the syringes to ensure that no air remains in the syringes and no leaks are visible at any of their fittings.
o
If leakage is found at a tube connector (
o
If there are air bubbles in the syringe ( B ), remove them by lightly tapping the
syringe with liquid flowing. If bubbles cannot be removed that way, call technical support.
o
If leakage is found at the bottom of the syringe ( C ), call technical support.
Roche Diagnostics
810 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 24 Maintenance of cobas e 602 module
As needed maintenance
5 Close the middle door of the module.
Roche Diagnostics
Operator’s Manual · 4.2.1
Figure 24-39 Reagent Prime window
6 Choose Utility > Maintenance > (8) Reagent Prime .
o
Select the Reagent option in the e 602 Prime Item area.
o
Enter 5 in the Cycles text box.
o
Choose Execute to start reagent priming.
o
During reagent prime, visually check that PreClean solution is dispensed from the Pre-wash dispenser in a straight flow. Otherwise, call technical support.
7
Choose Utility > Maintenance > (24) MC Preparation .
o
Select the Ch1,2 option and enter 30 in the Cycles text box.
o
Choose Execute to perform MC preparation 30 times on each channel.
8 Choose Utility > Maintenance > (8) Reagent Prime . o
Select the Pre-wash sipper option in the e 602 Prime Item area. o
Enter 5 in the Cycles text box.
o
Choose Execute to start reagent priming.
The e 602 modules are now ready for routine operation.
s
811
24 Maintenance of cobas e 602 module
As needed maintenance
Cleaning instrument surfaces
cobas® 8000 modular analyzer series
Spills on the instrument surface could be biohazardous and damage the surface.
Clean up all spills immediately. Use this procedure to ensure that surfaces on all modules are clean.
Materials required m
Disposable cloth or paper towels m
Laboratory disinfectant (no bleach)
Before performing this maintenance action, observe the following safety precautions: r
Infection from samples and associated materials (p. 27)
r
Skin inflammation or injury caused by reagents and other working solutions (p. 28)
r
Infection from waste solution and solid waste (p. 28)
r
Infection and injury due to contact with instrument mechanism (p. 581)
NOTICE Damage to instrument surfaces r Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
p To clean instrument surfaces
1
Power off the complete instrument or the desired module.
Or: Ensure the instrument is in Standby.
Or: Mask the module ( Start > Masking > Module Masking ) and wait until it is in
Standby.
2
Touch a screw at the rack loading area in order to discharge any static charge which may have built up on you.
3
Open the top cover of the module.
4
Clean the module surfaces using a cloth or paper towel moistened with disinfectant. Clean up all spills immediately. Use this procedure to ensure that surfaces are clean. If necessary, move the probes or units manually to clean the surface.
5
Close the top cover and lock it with the key.
6
If the module was masked, unmask it.
s
Roche Diagnostics
812 Operator’s Manual · 4.2.1
Troubleshooting
cobas® 8000 modular analyzer series
Table of contents
Data alarms
25 Data alarms
25
This chapter contains the data alarms generated by the cobas 8000 instrument. In addition to a description of the cause of each alarm and remedy, the analytical module of origin and automatic rerun conditions are described here.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
25
815
25 Data alarms
Table of contents
Roche Diagnostics
816 cobas® 8000 modular analyzer series
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
25 Data alarms
Roche Diagnostics
Operator’s Manual · 4.2.1
817
25 Data alarms
Table of contents cobas® 8000 modular analyzer series
Roche Diagnostics
818 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Introduction
Introduction
If any abnormality occurs while the system is switched on, the system notifies the operator of the potential problem by issuing an alarm. Alarms are classified into different types and levels: o
Data alarms refer to irregular measuring results or conditions.
o
Instrument alarms refer to irregular system conditions.
Alarm types and levels
Type
Data alarms:
Level
Data alarm
Meaning
This alarm is related to the results of calibrations, QC, or patient samples. The instrument does not stop operation.
Instrument alarms:
Table 25-1
Caution
S.Stop
(sampling stop)
Stop
This alarm is generated by data alarms or problems with the instrument. If this alarm occurs during operation, the instrument does not stop operation. The operator must judge whether to continue or interrupt the measurement.
This alarm is related to problems with the instrument.
For pipetted samples, the measurement continues.
This alarm is related to problems with the instrument.
The corresponding module or the entire instrument stops operation. For the sample under measurement, no result data are obtained and the measurement must be repeated.
E.Stop
(emergency stop)
This alarm is generated by hardware failures or if any of the safety devices requested an emergency stop. The system requires either complete power off, or at least a reset, to resume normal operation.
Alarm types and levels
Data alarms Data alarms are indicated on the Workplace > Data Review submenu, on the Test
Review window ( Workplace > Data Review > Test Review ), and on printed reports.
If a data alarm occurs, a flag is attached to the measurement result. These flags are names of three to six characters, which are all explained in this chapter.
For QC and patient samples, a data alarm consists of an alarm message and a result message. The result messages are specific to the tests.
Automatic rerun: Some data alarms trigger an automatic rerun. If such a data alarm occurs on a test for which automatic rerun is selected (check box on Utility
> Application > Range ), a rerun is automatically requested. For execution of the automatic rerun during measurement, however, automatic rerun needs to be activated on the Start window as well.
u
For more information, see Rerun list (p. 873)
Roche Diagnostics
Operator’s Manual · 4.2.1
819
25 Data alarms
Introduction cobas® 8000 modular analyzer series
Instrument alarms Instrument alarms are indicated by the Alarm button (global button) on the
Overview menu. An audible alarm can be activated additionally.
If an alarm occurs, the Alarm button lights up. Its color indicates the alarm level:
Color
Table 25-2
Meaning
Yellow indicates caution level.
Red indicates any alarm above caution level (S.Stop, Stop, or E.Stop).
Colors for instrument alarm levels
In case of an alarm, choose the Alarm button to open the Alarm window. This window provides an alarm list and descriptions and remedies for each listed alarm.
Roche Diagnostics
820 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarm list
Data alarm list
The following table displays the data alarms applicable to test results (also called sample flags ), and their presentation (flag) on submenus and reports.
q Alarms for calibration and QC measurements
Calibration and QC alarms are not included in the table below. u
For overviews about calibration and QC alarms, see:
Alarms for calibrations (p. 858)
Data alarm for controls (p. 869)
>Cuvet
Det.S
Edited
< >ISE
>I.H
>I.HI
>I.I
>I.L
>I.LH
>I.LHI
CarOvr
Cell.T
ClcT.E
Clot.E
CmpT.?
CmpT.E
>Curr
Curr.E
Flag
>AB
AB.E
>Abs
ADC.E
Calc.?
Cal.E (Sample flag)
Cal.I
>I.LI
Inc.T
ISE.E
ISE.N
>Kin
Table 25-3 List of sample flags
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm
AB level range over (Assay Buffer = ProCell)
AB level check error (Assay Buffer = ProCell)
ABS over
ADC abnormal
Calculation not possible
Calibration result abnormal (Sample flag)
Calibration result invalid
Potential carry over
Cell temperature
Calculation test error
Clot pressure abnormal
Unable to calculate comp. test (compensation test)
Data error in comp. test (compensation test)
Current range over
Current range check error
ABS Cell blank abnormal
Carry over detergent short
Edited test
ISE range over
Serum index interference hemolysis
Serum index interference hemolysis / icteric
Serum index interference icteric
Serum index interference lipaemia
Serum index interference lipaemia / hemolysis
Serum index interference lipaemia / hemolysis / icteric
Serum index interference lipaemia / icteric
Incubator temperature
ISE voltage level error
ISE noise error
Kinetic unstable (Prozone error 2)
–
–
–
–
–
ISE
–
–
–
–
–
–
–
–
–
–
–
–
c 701 c 702 c 502 e 602
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
821
25 Data alarms
Data alarm list cobas® 8000 modular analyzer series
>Rept / <Rept
Samp.?
Samp.B
Samp.C
Samp.O
Samp.S
<SigL
SLLD.E
SLLD.N
SysR.S
SysR.T
< >Test
>Test / <Test
WB.S
WB.T
Table 25-3
Over.E
>Proz
>React
ReagEx
Reag.F
Reag.H
Reag.S
Reag.T
Flag
>Lin
MIXLOW
MIXSTP na.LHI
OBS.RM
OBS.RR
List of sample flags
Alarm
Linearity abnormal
Mixing current low
Stop mixing
Serum index measurement not performed
On-board stability limit over on reagent manager
On-board stability limit over on reagent rotor
Overflow
Prozone error
Reaction limit over
Reagent expired date
Reagent film detection
Reagent hovering
Reagent short
Reagent disk temperature
Repeat limit over (upper) / (lower)
ABS maximum over (non-lin curve)
Sample air bubble
Sample clot
Sample carry over for modules
Sample short
Minimum signal
Sample LLD abnormal
Sample LLD noise
System reagent short
System reagent temperature
ISE sample range over
Technical limit over (upper) / (lower)
Washing buffer short
Washing buffer temperature
–
–
–
–
–
ISE
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– c 701 c 702 c 502 e 602
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
Roche Diagnostics
822 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Data alarms (cobas ISE module)
25 Data alarms
Data alarms (cobas ISE module)
ADC.E
Alarm ADC abnormal
Description The analog/digital converter is not working normally.
Cause Numerical conversion of the electromotive force is abnormal.
Remedy 1. If there are other instrument alarms at the same time, correct those alarms and resume operation.
2. Choose Utility > Maintenance and perform maintenance item (1) Reset. If the alarm recurs, call technical support.
Calc.?
Alarm Calculation not possible
Description The denominator becomes zero in calculation.
1. During calculation, the denominator became zero.
2. An overflow occurred in logarithmic or exponential calculation.
3. Result was left blank.
Cause Internal calculation error has occurred.
Remedy 1. Check the test that is flagged with an error message in the calculation.
2. Resume operation. If the alarm recurs, call technical support.
3. Recalibrate the test.
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
q Cal.E appears on each QC and patient sample for the affected test until the problem is resolved.
Cause An alarm, for example, Std.E, ISE.E, ISE.N, occurred during calibration.
Remedy 1. Correct the condition that occurred during the latest calibration and caused the alarm.
2. Recalibrate the test.
Roche Diagnostics
Operator’s Manual · 4.2.1
823
25 Data alarms
Data alarms (cobas ISE module)
Cal.I
cobas® 8000 modular analyzer series
Alarm Calibration result invalid
Description The result was generated with an invalid transferred calibration.
Cause The instrument requested a changeover calibration due to a change in a reagent pack for this test, but the calibration was not performed. Therefore, the reagent pack has an Invalid calibration until the calibration is performed.
This flag is attached to results if a test requires to be calibrated after replacement of a reagent pack and the automatic calibration masking is switched off.
Remedy Calibrate this reagent pack.
ClcT.E
Alarm Calculation test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the calculation. However, the ClcT.E alarm is not attached to the calculated test if one of the following alarms occurred for a test needed in the calculation: o
Overflow (Over.E) o
Sample carry over for modules (Samp.O) o
Reagent expired date (ReagEx) o
On-board stability limit over on reagent manager (OBS.RM) o
On-board stability limit over on reagent rotor (OBS.RR) o
Serum index data alarms
Remedy 1. Check the data alarm of the test to be used for the calculation.
2. Rerun the sample.
CmpT.?
Alarm Unable to calculate comp. test (compensation test)
Description During test-to-test compensation calculation, the denominator became zero. Blank space is left in the report.
Cause 1. The test used for test-to-test compensation has not been measured yet.
2. A test used for test-to-test compensation has a data alarm Calculation not possible
(Calc.?) or Data error in comp. test (compensation test) (CmpT.E).
3. A test used in the compensation formula has a data alarm that leaves the result blank (for example, Samp.S, Reag.S).
Remedy 1. Check the data alarm of the test to be used for compensation.
2. Rerun the sample.
Roche Diagnostics
824 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CmpT.E
25 Data alarms
Data alarms (cobas ISE module)
Alarm Data error in comp. test (compensation test)
Description 1. In test-to-test compensation calculation, a data alarm other than those shown below is indicated for the compensation test data.
2. Calculation not possible, Unable to calculate comp. test (compensation test),
Overflow, QC error and outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy 1. Check the data alarm on the test to be used for compensation.
2. Rerun the sample.
Edited
Alarm Edited test
Description An edited first result or rerun result is marked with an Edited alarm on the
Data Review submenu. The alarm is also printed on the patient report.
Cause The result has been manually changed.
Remedy Check the result of measurement.
Roche Diagnostics
Operator’s Manual · 4.2.1
825
25 Data alarms
Data alarms (cobas ISE module)
< >ISE
cobas® 8000 modular analyzer series
Alarm ISE range over
Description If the result is inside the following ranges, the < >ISE flag is attached to the result.
This alarm is effective for urine sample only.
Na +
K
+
Cl -
10 to 60 mmol/L
This alarm is not issued.
10 to 60 mmol/L
Cause The sample concentration is low.
Remedy 1. Perform a rerun with increased sample volume.
The instrument may also be programmed to repeat such tests automatically.
2. Perform maintenance item (18) Sample Probe Wash.
3. Clean the outside of the sample probe manually.
4. If the alarm recurs, call technical support.
>I.H
Alarm Serum index interference hemolysis
Description The hemolytic value is greater than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.HI
Alarm Serum index interference hemolysis / icteric
Description The hemolytic and icteric values are greater than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.I
Alarm Serum index interference icteric
Description The icteric value is greater than the specified reference value.
Cause A highly icteric sample was measured.
Roche Diagnostics
826 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas ISE module)
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.L
Alarm Serum index interference lipaemia
Description The lipemic value is greater than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LH
Alarm Serum index interference lipaemia / hemolysis
Description The lipemic and hemolytic values are greater than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LHI
Alarm Serum index interference lipaemia / hemolysis / icteric
Description The lipemic, hemolytic and icteric values are greater than the specified reference values.
Cause A highly lipemic, hemolytic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LI
Alarm Serum index interference lipaemia / icteric
Description The lipemic and icteric values are greater than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Roche Diagnostics
Operator’s Manual · 4.2.1
827
25 Data alarms
Data alarms (cobas ISE module)
ISE.E
cobas® 8000 modular analyzer series
Alarm ISE voltage level error
Description During measurement of internal reference, the measured voltages were not within the following ranges for ISE IS:
Na +
K
+
Cl -
-90.0 to -10 mV
-90.0 to -10 mV
80.0 to 160 mV
If an ISE.E data alarm is detected during an ISE measurement, the results of the two other ISE tests may also be effected. Therefore, the ISE.E data alarm is attached to all
ISE test results for this sample.
Cause o
The reference electrode is deteriorated.
o
Insulation is poor due to liquid leakage from the reference electrode mounting section.
o
ISE IS is deteriorated.
Remedy 1. Replace the reagent and perform maintenance item (8) Reagent Prime for the ISE module.
2. Replace the ISE electrodes and perform maintenance item (8) Reagent Prime for the ISE module.
3. Make sure that the O-ring is attached to the electrode joint and then perform maintenance item (8) Reagent Prime for the ISE module.
4. Replace the internal standard solution and perform maintenance item
(8) Reagent Prime for the ISE module.
5. Check that the electrode cords are correctly connected.
ISE.N
Alarm ISE noise error
Description In ISE measurement, the fluctuation in electromotive force exceeds the following value:
Na
+
K +
Cl
-
0.7 mV
1.0 mV
0.8 mV
If an ISE.N data alarm is detected during an ISE measurement, the results of the two other ISE tests may also be effected. Therefore, the ISE.N data alarm is attached to all
ISE test results for this sample. The ISE.N data alarm takes priority over ISE.E.
Cause o
Entry of air bubbles for lack of reagent o
Entry of air bubbles due to improper attachment of electrode o
Entry of air bubbles through sipper tube o
Poor insulation of waste solution block o
Poor insulation due to liquid leakage from sipper pipetter
Roche Diagnostics
828 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas ISE module)
Remedy 1. Check for sufficient reagent volume, make sure the tubing sits correctly in the
ISE REF bottle, and perform maintenance item (8) Reagent Prime for the ISE module (All).
2. Make sure that the O-ring is attached to the electrode joint and perform maintenance item (8) Reagent Prime for the ISE module (All).
3. Replace the sipper tube and perform maintenance item (8) Reagent Prime for the
ISE module (All).
4. Eliminate deposits.
5. Perform cleaning, checkup, and maintenance of the sipper syringe.
MIXLOW
Alarm Mixing current low
Description The ultrasonic monitor value is lower than the reference value.
Cause The mixer is deteriorated.
Remedy Call technical support.
na.LHI
Alarm Serum index measurement not performed
Description The serum index measurement could not be performed for the test.
Cause The serum index measurement could not be performed for the test for some reason.
Example 1: The remaining reagent volume for serum index testing is insufficient.
Example 2: The test is a high-priority immunoassay and the system is in the auto rerun mode. In that case, the serum index measurement cannot be performed before the high-priority immunoassay measurement.
Remedy 1. Check the remaining amount of reagent for serum index testing. Replace low reagent, as necessary.
2. If the flag is attached to a high-priority immunoassay and the system is in the auto rerun mode, rerun the serum index measurement.
Over.E
Alarm Overflow
Description Display is not possible because the result exceeds 6 digits
Cause The result contains more than 4 digits without decimal point and minus sign.
Examples: 0.123 or 12.34 or 123.4 or 1234
Roche Diagnostics
Operator’s Manual · 4.2.1
829
25 Data alarms
Data alarms (cobas ISE module) cobas® 8000 modular analyzer series
Remedy 1. Check the number of digits of the result. Only six digits including the minus sign and the decimal point are displayed.
2. Check that the number of decimal places in the application is appropriate.
3. Dilute the sample and perform a rerun.
Reag.S
Alarm Reagent short
Description There is insufficient ISE reagent volume. The liquid level cannot be detected in the reagent container.
Cause There is not enough reagent in the reagent container.
Remedy 1. Verify adequate reagent volumes. Replace low reagent, as necessary. Prime new reagent (if needed) and recalibrate.
2. If adequate reagent volumes are present, verify volumes on the Reagent menu.
Rerun the sample.
3. Resume operation. If the alarm recurs, call technical support.
>Rept / <Rept
Alarm Repeat limit over (upper) / (lower)
Description The result falls outside the repeat limit range programmed on Utility > Application
> Range .
Cause The sample concentration is higher (>Rept) or lower (<Rept) than the set value.
Remedy This alarm can be activated on Utility > System > Alarm Settings . If activated, the instrument may also be programmed to automatically repeat this test with normal sample volume.
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.
Cause A clot is detected.
Remedy 1. Perform maintenance item (18) Sample Probe Wash.
2. Check if there are clots in the sample.
3. If necessary remove the clots from the sample and rerun.
4. If the alarm recurs, call technical support.
Roche Diagnostics
830 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Samp.O
25 Data alarms
Data alarms (cobas ISE module)
Alarm Sample carry over for modules
Description Possible sample carryover must be considered when you check the results of the additional test(s) because special wash was not performed in the first run.
Cause An additional test that requires a special wash was performed and the module did not perform any special wash for the sample in the first run.
Remedy Repeat the measurement with a new sample aliquot.
q The second measurement will still have the Samp.O flag if the sample is rerun using the same sample ID. Results with Samp.O flags are acceptable when repeated with a new sample aliquot.
Samp.S
Alarm Sample short
Description The liquid level cannot be detected in the sample container.
Cause The sample volume is insufficient in the sample container.
Remedy 1. Add sample and rerun.
2. Resume operation. If the alarm recurs, call technical support.
< >Test
Alarm ISE sample range over
Description If the result is outside the following ranges, the flag ISE sample range over is issued.
For serum/plasma samples:
Na
+
K +
Cl
-
10–250 mmol/L
1–100 mmol/L
10–250 mmol/L
For urine samples with normal sample volume:
Na +
K
+
Cl -
10–350 mmol/L
3–100 mmol/L
10–350 mmol/L
For urine samples with increased sample volume:
Na
+
K +
Cl
-
20–60 mmol/L
The alarm is always attached independent of the result level.
20–60 mmol/L
Roche Diagnostics
Operator’s Manual · 4.2.1
831
25 Data alarms
Data alarms (cobas ISE module) cobas® 8000 modular analyzer series
Cause o
The electrode is deteriorated.
o
The flow path is contaminated.
o
Sample concentration is too high or too low.
Remedy 1. Are controls in range?
If Yes, go to 2.
If No, go to 3.
2. Continue with routine analysis. Continue with step 3 at the end of the day.
3. Replace the appropriate electrode.
u
See
Replacing the Na, K and Cl electrodes (p. 666).
4. Resume operation. If the alarm recurs, call technical support.
>Test / <Test
Alarm Technical limit over (upper) / (lower)
Description The sample concentration is outside the technical range entered on Utility
> Application > Range (ISE tests only).
For serum/plasma samples: o
Over the technical limit: If the result is greater than the upper limit, a >Test flag is attached to the result.
o
Under the technical limit: If the result is less than the lower limit, a <Test flag is attached to the result.
o
In both cases, a rerun test selection is generated and an automatic rerun is executed with normal sample volume (15 μ L).
For urine samples, this alarm is not generated as long as no values are entered in the
Technical Limit text boxes on Utility > Application > Range . Instead, an < >ISE alarm is attached if the result is outside the measuring range.
Cause Sample concentration is too high or too low.
Remedy 1. Manually dilute and rerun the diluted sample until the measured concentration is within the specified range. Be sure to calculate the original concentration from the measured value, using the correct dilution factor.
2. Perform maintenance item (18) Sample Probe Wash.
3. Clean the outside of the sample probe manually.
If the alarm recurs, call technical support.
Roche Diagnostics
832 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Data alarms (photometric modules)
25 Data alarms
Data alarms (photometric modules)
>Abs
Alarm ABS over
Description The absorbance value is checked for each wavelength. If a measured absorbance is beyond the limit of 33 000 absorbance units, this data alarm is attached to the result.
Cause o
The sample concentration is too high or the sample is lipemic.
o
The reagent has not been stored or handled properly.
o
Obstructions are in the optical path of the photometer.
Remedy o
If only one sample is affected: Check whether the sample is grossly lipemic or has an extremely high value. Follow your laboratory protocol for this situation.
o
If only one application is affected: Check reagent storage and handling for that test.
o
If all samples are affected:
O
Remove any obstructions in the optical path of the photometer. Make sure the lamp is on.
O
Choose Utility > Maintenance and perform maintenance item (5) Incubation
Water Exchange
O
Clean the incubator bath if it is contaminated.
u
See: Replacing reaction cells and cleaning incubator bath (p. 713).
o
Choose Utility > Maintenance and perform maintenance item (3) Photometer
Check.
o
Check the Photometer Check results on the printout (Abs < 14 000).
o
Replace the photometer lamp, if necessary.
o
Resume operation. If the alarm recurs, call technical support.
o
If all samples are affected intermittently:
For example, if any reaction cell is scratched, replace the cell.
u
For further instructions, see:
Replacing reaction cells and cleaning incubator bath (p. 713)
ADC.E
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm ADC abnormal
Description The analog-digital converter is not working normally.
Cause 1. Numerical conversion is abnormal.
2. The cell count is abnormal.
Remedy 1. If other instrument alarms exist, correct those alarms and resume operation.
2. Choose Utility > Maintenance and perform maintenance item (1) Reset.
833
25 Data alarms
Data alarms (photometric modules) cobas® 8000 modular analyzer series
3. If the alarm recurs, remove the reaction disk and check for water droplets or dust on sensors. Clean if necessary.
4. If the alarm recurs call technical support.
Calc.?
Alarm Calculation not possible
Description The denominator becomes zero in calculation.
o
During calculation the denominator became zero.
o
An overflow occurred in logarithmic or exponential calculation.
o
Result was left blank.
Cause Internal calculation error has occurred.
Remedy 1. Check the test that is flagged with an error message in the calculation. Dilute the sample and rerun the sample.
2. Check the Type list box in the Calibration Method area on Utility > Application
> Calib.
3. Resume operation. If the alarm recurs, call technical support.
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
q Cal.E appears on each QC and patient sample for the affected test until the problem is resolved.
Cause Any alarm (for example, Std.E) occurred during calibration.
Remedy 1. Correct the condition causing the alarm that occurred during the latest calibration.
2. Recalibrate.
Cal.I
Roche Diagnostics
834
Alarm Calibration result invalid
Description The result was generated with an invalid transferred calibration.
Cause The instrument requested a changeover calibration due to a change in a reagent pack for this test, but the calibration was not performed. Therefore, the reagent pack has an Invalid calibration until the calibration is performed.
This flag is attached to results if a test requires to be calibrated after replacement of a reagent pack and the automatic calibration masking is switched off.
Remedy Calibrate this reagent pack.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
ClcT.E
25 Data alarms
Data alarms (photometric modules)
Alarm Calculation test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the calculation. However, the ClcT.E alarm is not attached to the calculated test if one of the following alarms occurred for a test needed in the calculation: o
Overflow (Over.E) o
Sample carry over for modules (Samp.O) o
Reagent expired date (ReagEx) o
On-board stability limit over on reagent manager (OBS.RM) o
On-board stability limit over on reagent rotor (OBS.RR) o
Serum index data alarms
Remedy 1. Check the data alarm of the test to be used on the calculation.
2. Recalibrate.
CmpT.?
Alarm Unable to calculate comp. test (compensation test)
Description During test-to-test compensation calculation, the denominator became zero. Blank space is left in the report.
Cause 1. The test used for test-to-test compensation has not been measured yet.
2. A test used for test-to-test compensation has a data alarm Calculation not possible
(Calc.?) or Data error in comp. test (compensation test) (CmpT.E).
3. A test used in the compensation formula has a data alarm that leaves the result blank (for example, Samp.S, Reag.S).
Remedy 1. Check the data alarm of the test to be used for compensation.
2. Rerun the sample.
CmpT.E
Alarm Data error in comp. test (compensation test)
Description 1. In test-to-test compensation calculation, a data alarm for the compensation test data is indicated.
2. Calculation not possible, Unable to calculate comp. test (compensation test),
Overflow, QC error and outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy 1. Check the data alarm on the test to be used for compensation.
2. Rerun the sample.
Roche Diagnostics
Operator’s Manual · 4.2.1
835
25 Data alarms
Data alarms (photometric modules)
>Cuvet
cobas® 8000 modular analyzer series
Alarm ABS Cell blank abnormal
Description For a diluted test, the cell blank value of the second reaction cell exceeds the reference by more than 0.1 Abs. The reference is the stored value from the (4) Cell Blank
Measurement.
If a reaction cell fails the cell blank measurement, the system excludes it from any measurements.
For diluted tests, however, the system uses two reaction cells: o
1st cell: Contains sample and diluent.
o
2nd cell: Used for discharging diluted sample from the 1st cell, adding reagent, and performing the measurement.
The >Cuvet alarm indicates a failed cell blank measurement for the 2nd cell.
Cause Reaction cells are contaminated or damaged.
Remedy 1. Check that the reaction cell is not contaminated or cracked.
2. Choose Utility > Maintenance and perform maintenance item (7) Wash
Reaction Parts.
3. Ensure that there is no excessive foaming or particles in the incubator bath. If you notice excessive foaming or particles, perform maintenance item (5) Incubation
Water Exchange.
4. Wipe the outside of the reaction cells with a gauze pad moistened with incubator bath water. Perform maintenance item (5) Incubation Water Exchange.
5. Resume operation. If the alarm recurs, ensure there is adequate rinse water and cell blank water from the rinse mechanism. The cells must be completely filled.
6. Resume operation. If the alarm recurs, choose Utility > Maintenance and perform maintenance item (4) Cell Blank Measurement.
If an Abnormal Cell List is displayed on the Cell Blank Measurement report, the cell blank failed. For the cells listed in the Abnormal Cell List , the cell blank value differs more than ± 1000 (± 0.1 Abs) compared to cell no. 1. These cells need to be inspected (or replaced) and the (4) Cell Blank Measurement must be performed again.
u
For further instructions, see:
To perform a cell blank measurement (p. 703)
To view the cell blank measurement results (p. 703).
7. Resume operation. If the alarm recurs, call technical support.
Det.S
Alarm Carry over detergent short
Description If a special wash for the reagent probe is defined, the reagent probe is immersed in the specified detergent pack. This alarm occurs if the test is carried out even though the detergent volume is insufficient.
Cause The residual volume of the special wash detergent is insufficient.
Roche Diagnostics
836 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (photometric modules)
Remedy 1. Load a new detergent pack.
2. Check the results of the measurement and rerun the sample if necessary.
Edited
Alarm Edited test
Description An edited first result or rerun result is marked with an Edited alarm on the Data
Review submenu. This also prints on the patient report.
Cause The result has been manually changed.
Remedy Check the result of measurement.
>I.H
Alarm Serum index interference hemolysis
Description The hemolytic value is larger than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.HI
Alarm Serum index interference hemolysis / icteric
Description The hemolytic and icteric values are larger than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.I
Alarm Serum index interference icteric
Description The icteric value is larger than the specified reference value.
Cause A highly icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Roche Diagnostics
Operator’s Manual · 4.2.1
837
25 Data alarms
Data alarms (photometric modules)
>I.L
cobas® 8000 modular analyzer series
Alarm Serum index interference lipaemia
Description The lipemic value is larger than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LH
Alarm Serum index interference lipaemia / hemolysis
Description The lipemic and hemolytic values are larger than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LHI
Alarm Serum index interference lipaemia / hemolysis / icteric
Description The lipemic, hemolytic and icteric values are larger than the specified reference values.
Cause A highly lipemic, hemolytic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LI
Alarm Serum index interference lipaemia / icteric
Description The lipemic and icteric values are larger than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Roche Diagnostics
838 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
>Kin
25 Data alarms
Data alarms (photometric modules)
Alarm Kinetic unstable (Prozone error 2)
Description The prozone check value exceeds the specified limit value. (Reaction rate method)
Cause o
The sample concentration is too high. The monotone kinetic check value exceeds the specified limit for other tests.
o
The limit value is not set properly.
Remedy Dilute and rerun the sample or rerun the sample with a decreased sample volume.
>Lin
Alarm Linearity abnormal
Description In a rate assay, the reaction linearity exceeds the specified limit value.
Cause o
The photometer lamp has deteriorated.
o
The linearity check value is not set properly.
o
The sample is extremely lipemic.
o
The ultrasonic mixers are defective.
o
Debris in the incubator bath.
Remedy 1. Check the photometer lamp.
2. Dilute and rerun the sample.
3. Choose Utility > Application > Analyze to check the Linearity Limit .
4. Choose Utility > Maintenance > 2 Check (on Maintenance Type list) and perform maintenance check (9) Cuvette Mixing to check the ultrasonic mixing mechanisms.
5. Ensure the incubator bath is free of debris. Clean the incubator bath, if necessary.
u
See:
Replacing reaction cells and cleaning incubator bath (p. 713).
6. Resume operation. If the alarm recurs, call technical support.
MIXLOW
Alarm Mixing current low
Description The ultrasonic monitor value is lower than the reference value.
Cause The ultrasonic mixer is deteriorated.
Remedy 1. Clean the surface of the ultrasonic mixers.
u
See
Cleaning the ultrasonic mixers (p. 729).
2. Call technical support.
Roche Diagnostics
Operator’s Manual · 4.2.1
839
25 Data alarms
Data alarms (photometric modules)
MIXSTP
cobas® 8000 modular analyzer series
Alarm Stop mixing
Description There is no ultrasonic output for mixing.
Cause o
The water level in the incubator bath is too low.
o
The water level sensor of the incubator bath is abnormal.
Remedy 1. Supply water to the incubator bath.
2. Call technical support.
na.LHI
Alarm Serum index measurement not performed
Description The serum index measurement could not be performed for the test.
Cause The serum index measurement could not be performed for the test for some reason.
Example 1: The remaining reagent volume for serum index testing is insufficient.
Example 2: The test is a high-priority immunoassay and the system is in the auto rerun mode. In that case, the serum index measurement cannot be performed before the high-priority immunoassay measurement.
Remedy 1. Check the remaining amount of reagent for serum index testing. Replace low reagent, as necessary.
2. If the flag is attached to a high-priority immunoassay and the system is in the auto rerun mode, rerun the serum index measurement.
OBS.RM (cobas c 702 only)
Alarm On-board stability limit over on reagent manager
Description The on-board stability time for reagent packs in the buffer rotor is set on Utility
> Application > Range . The setting is fixed for each test, for example, 24 hours
(which is the maximum value). The OBS.RM alarm is attached to results if the onboard stability time of a reagent used for this test expired for more than 30 minutes
(e.g., 24 hours + 30 minutes).
Cause The system detected that the on-board stability time of the reagent pack on the reagent manager expired.
Remedy 1. Exchange the expired reagent pack.
2. Check the results of the measurement and rerun the sample if necessary.
Roche Diagnostics
840 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (photometric modules)
OBS.RR
Alarm On-board stability limit over on reagent rotor
Description The on-board stability time of the reagent pack used for this test has expired while it was on the reagent disk.
Cause The system detected that the on-board stability time of the reagent pack expired.
Remedy 1. Exchange the expired reagent pack.
2. Check the results of the measurement and rerun the sample if necessary.
Over.E
Alarm Overflow
Description Display is not possible because the result exceeds 6 digits
Cause o
The K factor has more than six digits due to the use of a wrong calibrator decimal point.
o
The result contains more than 4 digits without decimal point and minus sign.
Examples: 0.123 or 12.34 or 123.4 or 1234
Remedy 1. Check the number of digits of the result. Only six digits including the minus sign and the decimal point are displayed.
2. Check that the number of decimal places in the application is appropriate.
3. Dilute the sample and perform a rerun.
>Proz
Alarm Prozone error
Description The prozone check value exceeds the specified limit value. (Antigen readdition method)
Cause o
The sample concentration is too high.
o
The limit value is not set properly.
Remedy 1. Check the reagent preparation.
2. Dilute and rerun the sample or rerun the sample with decreased sample volume.
3. Choose Utility > Application > Analyze to check the upper prozone limit.
4. Resume operation. If the alarm recurs, call technical support.
>React
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm Reaction limit over
Description In a rate assay, the rate of change in main wavelength absorbance exceeds the specified limit value.
841
25 Data alarms
Data alarms (photometric modules) cobas® 8000 modular analyzer series
Cause o
The sample concentration is too high.
o
The reagent has been prepared improperly or deteriorated.
o
On Utility > Application > Analyze there is an improper setting in the Abs.
Limit line in the Increase/Decrease box.
Remedy 1. Verify the setting in the Increase/Decrease text boxes on Utility > Application
> Analyze .
2. Dilute and rerun the sample or rerun the sample with a decreased sample volume.
3. Prepare fresh reagent.
4. Check the stability and preparation of the reagent.
5. Replace the reagent if necessary.
ReagEx
Alarm Reagent expired date
Description The alarm indicates that an expired reagent was used; the test result is not guaranteed. The alarm can be inactivated under Utility > System > Alarm Settings .
Cause The system detected an expired reagent onboard the instrument.
Remedy 1. Check the Reagent Overview submenu for expired reagents.
u
For more information, see
Reagent Overview window (cobas ISE module) (p. 339)
Reagent Overview window (cobas c 701 and c 702 module) (p. 365).
2. Exchange expired reagents.
Reag.S
This section describes the Reag.S flag for c 701 / c 702 modules.
On c 701 / c 702 modules only
Alarm Reagent short
Description For photometric tests, there is insufficient reagent volume in the cobas c pack, or the liquid level cannot be detected in the cobas c pack.
Cause o
The reagent volume remaining on board is insufficient.
o
The reagent probe is not correctly aligned.
o
The reagent probe wire is not correctly attached.
Remedy 1. Verify adequate reagent volumes. Replace low reagent, as necessary. Prime new reagent (if needed) and recalibrate.
2. If adequate reagent volumes are present, verify volumes on the Reagent menu.
3. If alarm reoccurs, ensure that the reagent probe is correctly aligned and the probe wire is attached correctly.
4. Rerun the sample.
5. Resume operation. If the alarm recurs, call technical support.
Roche Diagnostics
842 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (photometric modules)
>Rept / <Rept
Alarm Repeat limit over (upper) / (lower)
Description The result falls outside the repeat limit range programmed on Utility > Application
> Range .
Cause The sample concentration is higher (>Rept) or lower (<Rept) than the set value.
Remedy This alarm can be activated on Utility > System > Alarm Settings . If activated, the system may also be programmed to automatically repeat this test with normal sample volume.
Samp.?
Alarm ABS maximum over (non-lin curve)
Description The absorbance of a sample is found to be equal or greater than the theoretical maximum absorbance (for infinite analyte concentration). The result field will be left blank on the report and Data Review submenu.
Cause The sample concentration is too high.
Remedy Dilute the sample and rerun. If automatic rerun is programmed, the sample will be rerun with a decreased sample volume.
Samp.C
Alarm Sample clot
Description The specified volume of sample is not aspirated.
u
For more information see Samp.C
Samp.O
Alarm Sample carry over for modules.
Description Possible sample carryover must be considered when you check the results of the additional test(s) because special wash was not performed in the first run.
Cause An additional test that requires a special wash was performed and the module did not perform any special wash for the sample in the first run.
Remedy Repeat the measurement with a new sample aliquot.
q The second measurement will still have the Samp.O flag if the sample is rerun using the same sample ID. Results with Samp.O flags are acceptable when repeated with a new sample aliquot.
Roche Diagnostics
Operator’s Manual · 4.2.1
843
25 Data alarms
Data alarms (photometric modules)
Samp.S
cobas® 8000 modular analyzer series
Alarm Sample short
Description The liquid level cannot be detected in the sample container.
u
For more information see Samp.S
>Test / <Test
Alarm Technical limit over (upper) / (lower)
Description The sample concentration is outside the technical range entered on Utility
> Application > Range .
o
Over the technical limit: Value is greater than the upper limit (>Test).
o
Under the technical limit: Value is less than the lower limit (<Test).
Cause Sample concentration is too high or too low.
Remedy 1. If >Test appears, decrease sample volume for rerun.
2. If <Test appears, increase sample volume for rerun.
3. Choose Utility > Application > Range to check the technical limit.
Roche Diagnostics
844 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Data alarms (cobas e 602 module)
25 Data alarms
Data alarms (cobas e 602 module)
>AB
AB.E
Calc.?
Alarm AB level range over (Assay Buffer = ProCell)
Description During run preparation, the ProCell signal level is out of range.
Cause ProCell is evaporated or may be contaminated.
Remedy 1. Check for air bubbles in the ProCell reservoir.
2. Replace with a new ProCell bottle.
3. Rerun all flagged samples.
4. If the error recurs, call technical support.
Alarm AB level check error (Assay Buffer = ProCell)
Description The ProCell level check failed.
Cause ProCell liquid level check failed. The ProCell volume is inadequate for run preparation.
Remedy 1. Replace the low volume bottle with a new bottle.
2. Perform a reagent prime for the e 602 module. Select the Reagent option to prime the ProCell reagent lines.
3. Rerun all flagged samples.
4. If the error recurs, call technical support.
Alarm Calculation not possible
Description The denominator becomes zero in calculation.
Cause Internal calculation error occurred.
Remedy Rerun the sample.
Roche Diagnostics
Operator’s Manual · 4.2.1
845
25 Data alarms
Data alarms (cobas e 602 module)
Cal.E (Sample flag)
cobas® 8000 modular analyzer series
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
q Cal.E appears on each QC and patient sample for the affected test until the problem is resolved.
Cause o
There is no valid calibration stored in the system.
o
The attempted calibration has failed.
o
Previous calibration data was used to calculate this result.
Remedy 1. Correct the condition causing the alarm that occurred during the latest calibration.
2. Check the calibrators and the cobas e pack and repeat the calibration.
3. Replace with new calibrators and a cobas e pack, if necessary. Repeat the calibration.
4. Rerun the sample.
Cal.I
Alarm Calibration result invalid
Description The result was generated with an invalid transferred calibration.
Cause The instrument requested a changeover calibration due to a change in a reagent pack for this test, but the calibration was not performed. Therefore, the reagent pack has an Invalid calibration until the calibration is performed.
This flag is attached to results if a test requires to be calibrated after replacement of a reagent pack and the automatic calibration masking is switched off.
Remedy Calibrate this reagent pack.
CarOvr (during first or rerun measurement)
Alarm Potential carry over
Description The signal level of this sample is low, a carry over in the measuring cell may have occurred.
Cause Microbead carryover from the previous sample may have occurred.
Exception: The potential microbead carryover flag was set, yet had no impact on a clinical decision.
Remedy 1. Rerun the sample.
2. Exception only in one of the following cases:
1) Qualitative assay results are below cutoff
2) Quantitative assays are below the lower limit of the clinical decision
Roche Diagnostics
846 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas e 602 module)
Cell.T
Alarm Cell temperature
Description Measuring cell temperature is out of range. The system performs an initial check
30 minutes after start-up. The temperature is checked continuously thereafter.
Cause o
The reagent disk cover is open. Radiation of heat does not work normally.
o
The room temperature is out of range.
Remedy 1. Verify the temperature of ProCell/CleanCell. Check that the fans at the rear of the module are operating normally and are unobstructed.
2. Check that room temperature is between 18 °C and 32 °C.
3. If the alarm recurs, call technical service.
Clot.E
Alarm Clot pressure abnormal
Description In checking the pressure sensor, overflow data is detected.
Cause There are air bubbles in the water flow tube.
Remedy 1. Choose Utility > Maintenance and perform maintenance item (22) Pipetter Air
Purge (10 cycles).
2. Resume measurement with new sample material. Or centrifuge the sample and then perform a rerun.
3. If the alarm recurs, call technical service.
>Curr
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm Current range over
Description The measuring cell current is out of range when checked during operation.
Cause Abnormal measuring cell condition.
o
There are air bubbles in the ProCell reservoir.
o
The electrode of the measuring cell is contaminated or deteriorated.
Remedy 1. Check for air bubbles in the ProCell reservoir.
2. Replace with a new ProCell bottle, if necessary.
3. Choose Utility > Maintenance and perform maintenance item (26) Liquid Flow
Cleaning (1 cycle).
During operation:
1. Choose Utility > Maintenance and perform maintenance item (24) MC
Preparation (10 cycles).
2. Rerun the sample.
3. If the alarm recurs immediately, call technical support.
847
25 Data alarms
Data alarms (cobas e 602 module)
Curr.E
cobas® 8000 modular analyzer series
Alarm Current range check error
Description The measuring cell current check failed.
Cause ProCell liquid level check failed. The ProCell volume is inadequate for run preparation.
Remedy 1. Replace the low volume bottle with a new bottle.
2. Rerun the sample.
3. If the alarm recurs immediately, call technical support.
Edited
Alarm Edited test
Description An edited first result or rerun result is marked with an Edited alarm on the
Data Review submenu. This also prints on the patient report.
Cause The result has been manually changed.
Remedy Check the result of measurement.
>I.H
Alarm Serum index interference hemolysis
Description The hemolytic value is greater than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.HI
Alarm Serum index interference hemolysis / icteric
Description The hemolytic and icteric values are greater than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Roche Diagnostics
848 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
>I.I
25 Data alarms
Data alarms (cobas e 602 module)
Alarm Serum index interference icteric
Description The icteric value is greater than the specified reference value.
Cause A highly icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.L
Alarm Serum index interference lipaemia
Description The lipemic value is greater than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LH
Alarm Serum index interference lipaemia / hemolysis
Description The lipemic and hemolytic values are greater than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
>I.LHI
Alarm Serum index interference lipaemia / hemolysis / icteric
Description The lipemic, hemolytic, and icteric values are greater than the specified reference values.
Cause A highly lipemic, hemolytic, and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Roche Diagnostics
Operator’s Manual · 4.2.1
849
25 Data alarms
Data alarms (cobas e 602 module)
>I.LI
cobas® 8000 modular analyzer series
Alarm Serum index interference lipaemia / icteric
Description The lipemic and icteric values are greater than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy 1. Check the results of measurement.
2. Perform a rerun of the sample with new sample material.
Inc.T
Alarm Incubator temperature
Description Incubator temperature is out of range. The system performs an initial check
30 minutes after start-up. The temperature is checked continuously thereafter.
Cause o
Radiation of heat does not work normally.
o
The room temperature is out of range
Remedy 1. Check the fans at the rear of the module are operating normally and are unobstructed.
2. Check that room temperature is between 18 °C and 32 °C.
3. Rerun the sample.
4. If the alarm recurs, call technical support.
na.LHI
Alarm Serum index measurement not performed
Description The serum index measurement could not be performed for the test.
Cause The serum index measurement could not be performed for the test for some reason.
Example 1: The remaining reagent volume for serum index testing is insufficient.
Example 2: The test is a high-priority immunoassay and the system is in the auto rerun mode. In that case, the serum index measurement cannot be performed before the high-priority immunoassay measurement.
Remedy 1. Check the remaining amount of reagent for serum index testing. Replace low reagent, as necessary.
2. If the flag is attached to a high-priority immunoassay and the system is in the auto rerun mode, rerun the serum index measurement.
Roche Diagnostics
850 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
OBS.RR
25 Data alarms
Data alarms (cobas e 602 module)
Alarm On-board stability limit over on reagent rotor
Description The on-board stability time of the reagent pack used for this test has expired while it was on the reagent disk.
Cause The system detected that the on-board stability time of the reagent pack expired.
Remedy 1. Exchange the expired reagent pack.
2. Check the results of the measurement and rerun the sample if necessary.
Over.E
Alarm Overflow
Description Display is not possible because the result exceeds 6 digits
Cause The result contains more than 4 digits without decimal point and minus sign.
Examples: 0.123 or 12.34 or 123.4 or 1234
Remedy 1. Check the number of digits of the result. Only six digits including the minus sign and the decimal point are displayed.
2. Check that the number of decimal places in the application is appropriate.
3. Dilute the sample and perform a rerun.
ReagEx
Alarm Reagent expired date
Description The alarm indicates that an expired reagent was used; the test result is not guaranteed. The alarm can be inactivated under Utility > System > Alarm Settings .
Cause The system detected an expired reagent onboard the instrument.
Remedy 1. Expired reagents are listed in the Reagent Load/Unload List as Expired in the
Reason column.
2. Exchange expired reagents.
Reag.F
Alarm Reagent film detection
Description The reagent probe detects a film or air bubbles in the cobas e pack.
Cause There is foam or film in the cobas e pack, the diluent reagent pack, or the pretreatment reagent pack.
Remedy Remove foam or film with a cotton swab.
Roche Diagnostics
Operator’s Manual · 4.2.1
851
25 Data alarms
Data alarms (cobas e 602 module)
Reag.H
cobas® 8000 modular analyzer series
Alarm Reagent hovering
Description The reagent probe hovers over the reagent disk.
Cause A premature LLD signal is detected during reagent pipetting.
Remedy 1. Dry the lids on the affected cobas e pack.
2. Check for bubbles in the affected cobas e pack.
3. Choose Utility > Maintenance and perform maintenance item (1) Reset.
4. If the alarm recurs, call technical support.
Reag.S
Alarm Reagent, diluent, or Pre-Treatment short
Description The liquid level cannot be detected in the cobas e pack.
Cause o
There is no reagent in the cobas e pack.
o
The volume of diluent or pre-treatment is insufficient.
o
The lead wire for the liquid level sensor is disconnected.
Remedy 1. Verify that reagent, diluent, and pre-treatment are adequate.
1) If the volume is not adequate, replace the low reagent pack and perform a reagent scan.
2) If the volume is adequate, verify volumes on the Reagent Overview window.
2. Verify that the lead wire is connected.
3. Resume operation and rerun the sample.
4. If the alarm recurs, call technical support.
Reag.T
Alarm Reagent disk temperature
Description Reagent disk temperature is out of range. The system performs an initial check
30 minutes after start-up. The temperature is checked continuously thereafter.
Cause o
Radiation of heat does not work normally.
o
The room temperature is out of range.
Remedy 1. Verify that the reagent disk cover is securely in place.
2. Check that the fans at the rear of the module are operating normally and are unobstructed.
3. Check that room temperature is between 18 °C and 32 °C.
4. If the alarm recurs, call technical support.
Roche Diagnostics
852 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas e 602 module)
>Rept / <Rept
Alarm Repeat limit over (upper) / (lower)
Description The result is greater than the specified upper limit value (>Rept) or smaller than the lower limit value (<Rept) programmed for the Range parameters on Utility
> Application .
Cause o
The sample concentration is higher than the set value (>Rept).
o
The sample concentration is lower than the set value (<Rept).
o
An improper repeat limit range is specified.
Remedy 1. Rerun the sample and check the measured value.
2. Specify a proper range for Repeat Limit on Utility > Application > Range .
Samp.B
Alarm Sample air bubble
Description o
The sample probe detects air bubbles on the sample.
o
Air bubble is detected in the sample syringe flow path when the sample is aspirated.
Cause o
There are bubbles in the sample container.
o
There are air bubbles in the water flow tube.
Remedy 1. Remove bubbles from sample tube with a cotton swab.
2. Choose Utility > Maintenance and perform maintenance item (22) Pipetter Air
Purge (10 cycles).
3. Rerun the sample.
Samp.C
Alarm Sample clot
Description A sample clot is detected during aspiration.
Cause o
The sample volume is insufficient.
o
There are clots in the sample.
Remedy 1. Fill the required volume into the sample container.
2. Check sample for fibrin.
3. Remove any clots or centrifuge the sample and then perform a rerun.
4. If clots could not be removed, rerun the sample with new sample material.
Roche Diagnostics
Operator’s Manual · 4.2.1
853
25 Data alarms
Data alarms (cobas e 602 module)
Samp.O
cobas® 8000 modular analyzer series
Alarm Sample carry over for modules.
Description Possible sample carryover must be considered when you check the results of the additional test(s) because no special wash was performed in the first run.
Cause An additional test that requires a special wash was performed and the module did not perform any special wash for the sample in the first run.
Remedy Repeat the measurement with a new sample aliquot.
q The second measurement will still have the Samp.O flag if the sample is rerun using the same sample ID. Results with Samp.O flags are acceptable when repeated with a new sample aliquot.
Samp.S
Alarm Sample short
Description The liquid level cannot be detected in the sample container.
Cause o
The sample volume in the sample container is insufficient.
o
The sample container is missing on the rack.
Remedy 1. Load the sample, if it is not on board.
2. Check the sample volume, add the required sample volume and rerun.
3. Resume operation.
4. If the alarm recurs, call technical support.
<SigL
Alarm Minimum signal
Description The signal level is extraordinarily low.
Cause o
The volume of the reaction mixture in the AssayCup is insufficient o
Reaction mixture contains clots o
Extremely high sample concentration for a competitive assay o
Abnormal measuring cell condition of detection unit (sipper/tubing/MC) o
ProCell is expired
Remedy 1. Rerun the sample.
OR: Rerun manually diluted sample.
2. Replace ProCell if expired.
3. If the alarm recurs, call technical support.
Roche Diagnostics
854 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas e 602 module)
SLLD.E
Alarm Sample LLD abnormal
Description The sample probe does not start LLD or LLD is not completed.
Cause 1. The tip of the sample probe is dirty.
2. The tip of the sample probe is wet.
Remedy 1. Clean the tip of the sample probe and resume measurement. If the alarm recurs, call technical support.
2. Dry the tip of the sample probe and resume measurement. If the alarm recurs, call technical support.
SLLD.N
Alarm Sample LLD noise
Description The sample probe detects noise or air bubbles on the sample.
Cause 1. The sample volume is insufficient.
2. There are bubbles in the sample container.
Remedy 1. Check sample volume.
2. Remove the bubbles with a cotton swab.
3. Rerun the sample.
SysR.S
Alarm System reagent short
Description The counted remaining number becomes 0, liquid short signal is detected, or the liquid level cannot be detected in the ProCell reservoir.
Cause The volumes in the auxiliary reagent bottles (ProCell and CleanCell) are insufficient.
Remedy 1. Check the volumes in the ProCell/CleanCell bottles and replace, if necessary.
2. Resume operation.
3. Rerun the sample.
SysR.T
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm System reagent temperature
Description ProCell/CleanCell temperature is out of range. The system performs an initial check
30 minutes after start-up. The temperature is checked continuously thereafter.
Cause 1. Radiation of heat does not work normally.
2. The room temperature is out of range.
855
25 Data alarms
Data alarms (cobas e 602 module) cobas® 8000 modular analyzer series
Remedy 1. Check the fans at the rear part of the module are operating normally and are free of obstructions.
2. Check that room temperature is between 18 °C and 32 °C.
3. If the alarm recurs, call technical support.
>Test / <Test
Alarm Technical limit over (upper) / (lower)
Description o
Upper technical limit exceeded:
The measured value is higher than the measuring range (>Test).
o
Lower technical limit exceeded:
The measured value is lower than the measuring range (<Test).
Cause o
The sample concentration is above the upper limit of the measuring (reportable) range (>Test).
o
The sample concentration is below the lower limit of the measuring (reportable) range (<Test).
Remedy 1. If >Test, rerun using the recommended dilution and check the measured value.
2. If <Test, report the result as less than the lower detection limit of the assay. Rerun is not requested.
WB.S
Alarm Washing buffer short
Description The remaining volume for PreClean is 0, or liquid short signal is detected.
Cause There is no reagent in the reagent bottle.
Remedy 1. Replace with a new PreClean bottle.
2. Resume operation.
3. Rerun the sample.
WB.T
Alarm Washing buffer temperature
Description PreClean temperature is out of range. The system performs an initial check
30 minutes after start-up. The temperature is checked continuously thereafter.
Cause 1. Radiation of heat does not work normally.
2. The room temperature is out of range.
Roche Diagnostics
856 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarms (cobas e 602 module)
Remedy 1. Check that the fans at the rear of the module are operating normally and are unobstructed.
2. Check that room temperature is between 18 °C and 32 °C.
3. If the alarm recurs, call technical support.
Roche Diagnostics
Operator’s Manual · 4.2.1
857
Flag
Rsp1.E
Rsp2.E
S1A.E
SD.E
Sens.E
>Sig
<Sig
Sig.E
Cal.E
Cond.E
Diff.E
Dup.E
Factor
IStd.E
Mono.E
Prep.E
Slop.E
Std.E
Sys.E
Table 25-4
Cal.E
25 Data alarms
Alarms for calibrations
Alarms for calibrations
cobas® 8000 modular analyzer series
Alarm
CALIB error (Calib flag)
Conditioning (ISE) abnormal
Minimum acceptable difference
Duplicate error
Factor
IS concentration abnormal
Monotony of curve
Preparation abnormal
Response (ISE) abnormal 1
Response (ISE) abnormal 2
S1ABS abnormal
SD limit error
Sensitivity error
Maximum Signal
Minimum Signal
Minimum/Maximum Signal
Slope abnormal
Standard error
System errors
Data alarm list
The following table displays all calibration data alarms applicable for the modules.
q Calibration flags are indicated on the Calibration Trace window and on the Calibration
Monitor report.
For the e 602 module, calibration alarms are always indicated by an asterisk ( * ) on the
Calibration Trace window. This is used as a wildcard for all calibration flags. Please check the Calibration Monitor report to find out which calibration flag occurred.
ISE
–
–
–
–
–
–
–
–
–
–
– e 602
–
–
–
–
–
–
–
–
–
–
–
c 502
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– c 701 / c 702
–
–
–
–
–
–
–
Alarm CALIB error (Calib flag)
Displayed in Calibration > Status > Calibration Trace .
Description The current slope value differs from the previous one by more than the specified
Compensated Limit on Utility > Application > Calib . The Compensated Limit is a limit for the difference | previous value – current value | expressed as percentage of the average (previous value + current value)/2.
For ISE calibrations, the S3 concentration is checked additionally by applying a limit of the Compensated Limit multiplied by a fixed factor of 0.25. If this check fails, the
Cal.E alarm is also issued.
Roche Diagnostics
858 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Alarms for calibrations q The Cal.E alarm is a warning only, and does not necessarily indicate a calibration problem.
Check the test’s control recovery before accepting the new calibration result.
Cause o
The standard solution or reagent is not placed in proper position.
o
The reagent has deteriorated or the standard solution has become concentrated due to evaporation.
Remedy 1. Correct any other instrument and/or data alarms.
2. Check standards, reagents, and controls. If controls are in range, and standards and reagents are acceptable, resume operation. Otherwise, correct abnormalities and recalibrate.
3. For ISE, check Compensated Limit on Utility > Application > Calib.
Cond.E
Alarm Conditioning (ISE) abnormal
Description
The slope value is 68.1 mV or greater for Na
+
or K
+ electrodes, or it is -68.1 mV or less for the Cl
-
electrode. The conditioning is inadequate.
Alarm message Slope value
Cl
-
-68.1 mV or less
-68.0 mV to -40.0 mV
K
+
68.1 mV or more
68.0 mV to 50.0 mV
Na
+
68.1 mV or more
68.0 mV to 50.0 mV
-39.9 mV to -35.0 mV
-34.9 mV or more
Table 25-5
49.9 mV to 45.0 mV
44.9 mV or less
49.9 mV to 45.0 mV
44.9 mV or less
Slope values for ISE measuring electrodes
Conditioning inadequate
(Normal range)
ISE prepare error
ISE slope error
Cond.E
Prep.E
Slop.E
1D .
6ORSH( 3UHS( 1RUPDOUDQJH &RQG(
P9
&O
&RQG( 1RUPDOUDQJH 3UHS( 6ORSH(
P9
Figure 25-1 ISE data alarms and corresponding slope values (electrode voltage) q Judgement on ISE electrode replacement o If one of the alarms Preparation abnormal (Prep.E) or ISE slope error (Slop.E) appear during calibration, replace the electrodes at once.
o Normally, the slope values slightly decrease with time and use. If there is a large change compared to the value of the previous day, the cause may be other than deteriorated electrodes. Check for air bubbles in or leakage from the flow path, an error in substitution of standard solution, contamination of the flow path, etc.
Cause o
Conditioning of a new electrode is unsatisfactory.
o
The concentration of standard solution LOW/HIGH is improper.
Roche Diagnostics
Operator’s Manual · 4.2.1
859
25 Data alarms
Alarms for calibrations cobas® 8000 modular analyzer series
Remedy 1. Perform green wash rack with activator on the 3rd position.
2. Pour fresh calibrator ISE Low (S1) [Std(1)], ISE High (S2) [Std(2)], and ISE High
(S3) [Std (3)], place on calibration rack and recalibrate the ISE units.
3. Resume operation. If the alarm recurs, call technical support.
Diff.E
Alarm Minimum acceptable difference
Description If the difference between the mean of level 1 and level 2 calibrator is below the permissible value, the calibration is failed.
Cause o
The ProCell is expired.
o
The calibrator does not reach room temperature.
Remedy 1. Replace ProCell.
2. Set the calibrator appropriately.
3. Recalibrate.
Duplicate error
This section describes the duplicate error for photometric modules and for immunological modules.
Dup.E (photometric modules)
Alarm Duplicate error
Displayed on Calibration > Status > Calibration Trace .
Description The difference between the first and second measurement (absorbance) of a calibrator is outside the specified range.
The following steps describe how a decision is made to flag a calibration for violating the duplication limit.
1. The absorbance for a calibrator (N) is measured twice.
2. The % of error and absorbance error are computed.
3. Is the absorbance error < Duplicate Limit Abs. that appears on Utility
> Application ?
If yes, go to step
.
4. Continue with result calculations. No Dup.E alarm is issued.
5. Is the % error < the % Duplicate Limit?
If yes, go to step
.
6. Dup.E alarm is issued for this result.
Roche Diagnostics
860 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Alarms for calibrations
Cause The difference between the first and second measurement (absorbance) of a calibrator is greater than Duplicate Limit Abs and greater than the % Duplicate Limit.
Remedy 1. Recalibrate.
2. Check reagent storage, handling and expiration date. Replace the reagent if necessary and recalibrate.
3. If the alarm recurs, call technical support.
q If this alarm occurs, a Std.E alarm is issued. The Std.E alarm prevents updating of calibration for the affected test.
Dup.E (immunological modules)
Alarm Duplicate error ( e 602)
Displayed on Calibration > Status > Calibration Result .
Description The difference between the first and second measured signal of the calibrator is out of the range specified in the assay ( Utility > Application > Calib.
).
Cause o
Air was aspirated during the first determination due to air bubbles on the corresponding calibrator. During the second determination no air was aspirated.
o
Consequence: The signal values of the first and second determination differ more than the specified percentage.
Remedy Verify that there are no air bubbles on the surface of the calibrator and perform a new calibration.
Factor
Alarm Factor
Description Each new lot calibration utilizes a calibration factor of 1. For all subsequent reagent pack calibrations, a new calibration factor is calculated. The calibration factor is the quotient of the slopes of the currently performed calibration and the related stored calibration. The calibration factor is only used as calibration validation criteria and not used for sample calculation.
This is a calibration check only for quantitative immunoassays.
Cause Failed calibration (red on Calibration > Status ): Range < 0.8 or > 1.2
Remedy Recalibrate.
IStd.E
Alarm IS concentration abnormal
Displayed on Calibration > Status > Calibration Trace .
Roche Diagnostics
Operator’s Manual · 4.2.1
861
25 Data alarms
Alarms for calibrations cobas® 8000 modular analyzer series
Description The concentration of the Internal Standard solution (ISE IS) was not within the following ranges:
Na +
K
+
Cl -
120.0–160.0 mmol/L
3.0–7.0 mmol/L
80.0–120.0 mmol/L
Cause o
The flow path is contaminated.
o
The reagent has deteriorated.
Remedy 1. If the measured voltage of ISE IS is abnormal on the calibration report, check the
ISE IS reagent volume. If necessary, perform a reagent prime and recalibrate.
2. If the measured voltage of ISE IS is normal on the calibration report, check ISE reagent syringe. The measured voltage of ISE IS ideally lies midway between the low and the high standard. The ideal ISE IS concentrations values are: Na
+
:
140 mmol/L; K
+
: 5 mmol/L; Cl
-
: 100 mmol/L.
3. Perform maintenance item (8) Reagent Prime for the ISE module to wash the flow path.
4. Replace the internal standard solution and recalibrate.
5. Resume operation. If the alarm recurs, call technical support.
Mono.E
Alarm Monotony of curve
Description The working curve is not monotonically increasing or monotonically decreasing.
This is a calibration check only for quantitative immunoassays.
Cause o
The ProCell is expired.
o
The calibrator did not reach room temperature.
Remedy 1. Replace ProCell.
2. Place the calibrator appropriately.
Roche Diagnostics
862 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Alarms for calibrations
Prep.E
Alarm Preparation abnormal
Displayed on Calibration > Status > Calibration Trace .
Description
The slope value is within the following range: 45.0 to 49.9 mV for Na
+
or K
+ electrodes, -39.9 to -35.0 mV for the Cl
-
electrodes. This alarm causes a failed calibration.
1D .
6ORSH( 3UHS( 1RUPDOUDQJH &RQG(
P9
&O
&RQG( 1RUPDOUDQJH 3UHS( 6ORSH(
Figure 25-2 ISE data alarms and corresponding slope values (electrode voltage)
Cause o
The electrode is deteriorated.
o The flow path is contaminated.
Remedy 1. Replace the electrode.
2. Perform maintenance item (8) Reagent Prime to prime the lines.
3. Prepare fresh calibrator; place on calibration rack and recalibrate the ISEs.
4. Resume operation. If the alarm recurs, call technical support.
u
For more information on ISE calibration alarms, see:
P9
Rsp1.E
Roche Diagnostics
Operator’s Manual · 4.2.1
Alarm Response (ISE) abnormal 1
Description The compensation factor is over the limits (narrower range).
Cause o The flow path is contaminated.
o
The electrode is contaminated or deteriorated.
Remedy 1. Check ISE controls for correct levels.
2. If incorrect, go to step
3 before continuing routine analysis.
If correct, go to step 3 after finishing routine analysis at the end of the day.
3. Choose Utility > Maintenance and perform maintenance item (28) ISE System
Wash to wash the flow path.
4. Perform green wash rack with SysClean (pos. 2) and Activator (pos. 3).
5. Prepare fresh calibrator; place on calibration rack and recalibrate the ISEs.
6. Resume operation. If the alarm recurs, repeat steps
a maximum of two times. If the alarm recurs, replace the ISE electrodes.
863
25 Data alarms
Alarms for calibrations
Rsp2.E
cobas® 8000 modular analyzer series
Alarm Response (ISE) abnormal 2
Description The compensation factor is over the limits (wider range).
Cause o
The flow path is contaminated.
o
The electrode is contaminated or deteriorated.
Remedy u
S1A.E
Alarm S1ABS abnormal
Displayed on Calibration > Status > Calibration Trace .
Description During calibration, expected absorbance is outside the S1 Abs Limit. S1 is read bichromatically for endpoint assays, monochromatically for rate assays.
Cause o
The reagent has been stored or handled improperly or has deteriorated.
o
An improper absorbance range is specified for calibrator 1.
Remedy 1. Check reagent storage and handling and calibrator preparation, if applicable.
2. Recalibrate.
3. Check S1 Abs. Limit values on Utility > Application > Calib.
4. Resume operation. If the alarm recurs, call technical support.
SD.E
Alarm SD limit error
Description During nonlinear or multipoint linear calibration, the SD value was greater than the
SD limit programmed on Utility > Application > Calib.
Cause o
The calibrator is not placed in a correct position.
o
An improper SD limit value is specified.
Remedy 1. Check calibrator positions on Calibration > Calibrators .
2. Choose Utility > Application > Calib.
to check the SD limit.
3. Check reagent storage and handling and calibrator preparation. Recalibrate the affected test.
4. Check the standard concentrations on Calibration > Install . For a calibration with automatic standard dilution; check whether the ratio between concentration, sample, diluent volume and diluted sample is correct on Utility > Application
> Other .
5. Resume operation. If the alarm recurs, call technical support.
Roche Diagnostics
864 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Sens.E
25 Data alarms
Alarms for calibrations
Alarm Sensitivity error
Description Sensitivity is checked for linear (2 to 6 points), nonlinear, or isozyme-P calibration.
This alarm is indicated if the sensitivity value obtained in a calibration falls out of the sensitivity limits specified on Utility > Application > Calib.
q For span calibration, the previous S1 Abs (linear) or previous mean absorbance (nonlinear) of calibrator (1) is used for the sensitivity check.
Cause o
The calibrator is not placed in a proper position.
o
The reagent has been prepared improperly or has deteriorated.
An improper sensitivity limit is specified.
Remedy 1. Check preparation and expiration dates of calibrators and reagents. Recalibrate the affected test.
2. Check sample pipetter for leaks and recalibrate the affected test.
3. Choose Utility > Application > Calib.
to check the sensitivity limit and recalibrate the affected test.
4. Resume operation. If the alarm recurs, call technical support.
>Sig
Alarm Maximum Signal
Description The calibrator signal is greater than the specified upper limit value. Only for qualitative assays.
Cause o
The ProCell is expired.
o
The calibrator does not reach room temperature.
o
The calibrator was mixed up.
Remedy 1. Replace ProCell.
2. Place the calibrator appropriately.
3. Recalibrate.
<Sig
Alarm Minimum Signal
Description The calibrator signal is lower than the specified lower limit value. For qualitative and quantitative assays.
Cause o
The ProCell is expired.
o
The calibrator was mixed up.
o
Failure during reconstitution of the calibrator.
Roche Diagnostics
Operator’s Manual · 4.2.1
865
25 Data alarms
Alarms for calibrations
Remedy 1. Replace ProCell.
2. Place the calibrator appropriately.
3. Recalibrate.
cobas® 8000 modular analyzer series
Sig.E
Alarm Minimum/Maximum Signal
Description The measured signal of a calibrator for a qualitative test should fall between the designated minimum and maximum signal. If one or more values fall out of the allowable minimum/maximum signal range, the calibration fails.
Cause The measured signal of a calibrator for a qualitative test lies outside the designated minimum/maximum signal range.
Remedy 1. Check the calibrators and reagents and repeat the calibration.
2. Set new calibrators and a cobas e pack, if necessary, and repeat calibration.
Slop.E
Alarm Slope abnormal (ISE only)
Displayed on Calibration > Status > Calibration Trace .
Description
The slope value is less than 45.0 mV for Na
+
or K
+ electrodes, or greater than -35 mV for the Cl
-
electrode. This alarm causes a failed calibration.
1D .
6ORSH( 3UHS( 1RUPDOUDQJH &RQG(
P9
&O
&RQG( 1RUPDOUDQJH 3UHS( 6ORSH(
Figure 25-3 ISE data alarms and corresponding slope values (electrode voltage)
Cause o
The electrode is deteriorated.
o Standard solutions Low and High are not placed in the proper positions.
o
The sample probe is clogged.
Remedy 1. Replace the appropriate ISE electrode before continuing routine analysis.
2. Perform green wash rack with activator on the 3rd position.
3. Prepare fresh calibrator; place on calibration rack and recalibrate the ISEs.
4. Resume operation. If the alarm recurs, call technical support.
u
For more information on ISE calibration alarms, see:
P9
Roche Diagnostics
866 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Alarms for calibrations
Std.E
This section describes the Std.E flag for the ISE module and for photometric modules.
cobas ISE module
Alarm Standard error
Description Two cases must be distinguished: o
Case 1: During ISE calibration, one of the alarms listed in table
occurred.
o
Case 2: During calibration, calculation was disabled.
Table for case 1:
Data alarm Data flag
ADC abnormal
Calculation not possible
ISE voltage level error
ISE noise error
ADC.E
Calc.?
ISE.E
ISE.N
Mixing current low
Sample short
Table 25-6
MIXLOW
Samp.S
Data alarms causing a Std.E alarm when occurring in calibration q The calibration is not updated if this alarm is issued; i.e., the prior calibration remains in effect.
Cause o
The reagent is empty and has to be replaced.
o
The concentration of calibrator is incorrect or the calibrator is not placed in the proper position.
o
An improper check value is specified.
Remedy 1. Correct all other instrument and/or data alarms.
2. Prepare fresh calibrator, place on the rack, and recalibrate.
3. Replace reagent, prime, and recalibrate.
4. Choose Utility > Application > Calib.
to check the calibration parameters.
5. Resume operation. If the alarm recurs, call technical support.
Photometric modules
Alarm Standard error
Description Three cases must be distinguished: o
Case 1: During photometric calibration, one of the alarms listed in table
occurred.
o
Case 2: During calibration, calculation was disabled.
o
Case 3: During nonlinear calibration, an extreme value appeared.
Roche Diagnostics
Operator’s Manual · 4.2.1
867
25 Data alarms
Alarms for calibrations cobas® 8000 modular analyzer series
Table for case 1:
Data alarm Data flag
ABS over
ADC abnormal
Calculation not possible
ABS Cell blank abnormal
Duplicate error
Linearity abnormal
Mixing current low
>Abs
ADC.E
Calc.?
>Cuvet
Dup.E
>Lin
MIXLOW
Stop mixing
Prozone error, Kinetic unstable (Prozone error 2)
Sample short
Table 25-7
(1) Not for Std.1
MIXSTP
>Proz, >Kin
(1)
>React Reaction limit over
Reagent short
S1ABS abnormal
Reag.S
S1A.E
Samp.S
Data alarms causing a Std.E alarm when occurring in calibration q The calibration is not updated if this alarm is issued; i.e., the prior calibration remains in effect.
Cause o
The reagent has not been stored or handled properly or is empty and has to be replaced.
o
The concentration of calibrator is incorrect or the calibrator is not placed in the proper position.
o
An improper check value is specified.
Remedy 1. Correct all other instrument and/or data alarms.
2. Prepare fresh calibrator, place on the rack, and recalibrate.
3. Replace reagent and recalibrate.
4. Choose Utility > Application > Calib.
to check the calibration parameters.
5. Resume operation. If the alarm recurs, call technical support.
Sys.E
Alarm System errors
Description An error occurred on the system during measurement.
Cause Check the Alarm window.
Remedy 1. Eliminate problems with the instrument, referring to the Alarm window.
2. If the alarm recurs, call technical support.
Roche Diagnostics
868 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data alarm for controls
Data alarm for controls
QC results are validated on the data manager regarding the set rules. After validation is performed, the QC results are transferred back to the instrument. q On the instrument, invalid QC results are always indicated by the QCErr flag. Check the data manager for details.
Flag Alarm
QCErr
Table 25-8
QC error
Data alarm list
ISE
c 701 / c 702
c 502 e 602
QCErr
Alarm QC error
Description o
The QC result is not within the defined range.
o
No Westgard rule is assigned to the test.
o
There are not enough QC values available for evaluation of the Westgard rule.
Cause o
Reagent is deteriorated.
o
Poor precision due to leakage of the pipetter joint.
o
Proper control values (mean value, standard deviation) are not specified.
o
Improper preparation or storage of controls.
o
Missing Westgard rule assignment.
o
Missing QC values.
Remedy 1. Check that the controls are properly prepared, positioned, and stored.
2. Check that the target value and SD for the specified test are entered correctly on the data manager component QC Parameter .
3. Register a new reagent pack.
4. Prepare new control material.
5. Assign a Westgard rule to the test.
6. Run more QC samples.
Roche Diagnostics
Operator’s Manual · 4.2.1
869
25 Data alarms
Data problems without alarm
Data problems without alarm
cobas® 8000 modular analyzer series
This chapter provides general information about data problems on the cobas 8000 instrument without alarm.
Drift of result data
Cause o
Concentration or deterioration of sample o
The calibrator is concentrated or deteriorated.
o
The reagent flow path is contaminated. (ISE module)
Remedy 1. Avoid leaving the sample in the sample cup for extended periods.
2. Perform maintenance item (28) ISE System Wash.
Erroneous operation
Cause o
Neglect of preliminary or periodical check(s).
o
Carryover between tests.
o
Fibrin contained in sample or dust contained in reagent.
o
The sample container used was not recommended.
Remedy 1. Carry out preliminary and/or periodical check according to the specified procedure.
2. Change the channel, use the wash program, or take any other measure after consulting with the reagent manufacturer.
3. Eliminate fibrin or dust. Be sure to check the sample and reagent before setting them.
4. Perform maintenance item (18) Sample Probe Wash.
5. Use the recommended sample container.
Poor reproducibility
Cause o
A maintenance item is overdue.
o
Deterioration of reagent or precipitation of insoluble matter.
o
Deterioration of ProCell, CleanCell, or PreClean.
o
Poor deionized water quality.
o
Incorrect reagent handling.
o
Test parameters are not set properly.
Remedy 1. Carry out daily checks and periodical maintenance according to the specified maintenance procedure.
2. Replace with a new reagent pack. Do not add or mix old and new reagent.
3. Replace with new ProCell/CleanCell or PreClean bottles ( e 602).
4. The water quality must be 1 μ S/cm (microsiemens per cm) or less.
5. Handle reagents according to manufacturer’s recommendation.
Roche Diagnostics
870 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Data problems without alarm
6. Check the completeness of the special wash list. If necessary, install the special wash list according to the recommendation of the manufacturer.
7. Check the application setting of the Open/Close mode on Utility > Application
> Range . The usage of the Cap Open/Close mode open upon pipetting is recommended for all tests in order to guarantee maximum reagent stability.
Result data at high level
Cause o
Concentration of control or sample.
o
Deterioration of calibrator.
o
Deterioration of ProCell or CleanCell ( e 602).
o
The reagent, control, or standard handling was not done as recommended.
Remedy 1. Avoid leaving the sample or control in the sample cup for extended periods.
2. Avoid leaving the calibrator cup open for extended periods.
3. Replace with new ProCell/CleanCell bottles ( e 602).
4. Handle reagents, calibrators and controls according to manufacturer’s recommendation.
Result data at low level
Cause o
Concentration of calibrator.
o
Reagent was not stored or handled as recommended.
o
The test parameters are not set properly.
o
Deterioration of ProCell or CleanCell ( e 602).
Remedy 1. Use the calibrator immediately after opening the cap of the vial.
2. Replace the reagent.
3. Set the concentration of calibrator properly (not for e 602).
4. Replace with new ProCell/CleanCell bottles ( e 602).
Trouble attributed to characteristics of reagent
Cause o
Cross contamination (high value, low value) o
Coloring matter adheres to the reaction cell.
Remedy 1. Perform maintenance item (7) Wash Reaction Parts.
2. Check whether the special wash list is complete. Install the special wash list according to the manufacturer’s recommendations.
u
Trouble for each test
Cause o
Improper preparation or management of calibrator or control (high value, low value).
o
Improper management of reagent (low value).
Roche Diagnostics
Operator’s Manual · 4.2.1
871
25 Data alarms
Data problems without alarm cobas® 8000 modular analyzer series
Remedy 1. Prepare a new calibrator or control.
2. Replace with a new reagent pack.
3. Set the test parameters properly according to the setting table given by the reagent manufacturer.
Trouble on each analytical module
Cause o
Air bubbles in the sample or reagent syringe (poor reproducibility).
o
Liquid leakage from sample or reagent syringe (poor reproducibility).
o
Deterioration of ProCell, CleanCell, or PreClean ( e 602).
Remedy 1. Carry out maintenance and inspection.
2. Replace with new ProCell/CleanCell or PreClean bottles.
Trouble on each channel in same module
Cause o
Air bubbles in the sipper syringe (poor reproducibility).
o
Liquid leakage from sipper syringe (poor reproducibility).
o
The electrode of the measuring cell is contaminated or deteriorated (high value or low value).
Remedy 1. Call technical support.
2. Perform maintenance item (26) Liquid Flow Cleaning according to the specified procedure.
Roche Diagnostics
872 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 25 Data alarms
Rerun list
Rerun list
I
N
D
NR
N/A
The following table indicates whether a rerun is automatically requested by the system when a data alarm is attached to a result. The rerun conditions are displayed for each module. The automatic rerun column indicates whether a rerun is automatically performed by the system.
u
For more information on performing reruns, see Automatic reruns (p. 493)
Sample is rerun with an increased sample volume
Sample is rerun with the same ( normal ) sample volume (repeat)
Sample is rerun with a decreased sample volume
No rerun is performed on this module
Not applicable
Flag Alarm ISE
>AB
AB.E
>Abs
ADC.E
AB level range over (Assay Buffer = ProCell) -
AB level check error (Assay Buffer = ProCell) -
ABS over
ADC abnormal
-
N
Calc.?
Calculation not possible
Cal.E (Sample flag) Calibration result abnormal (Sample flag)
Cal.I
CarOvr
Calibration result invalid
Potential carry over
N
-
N
N
Cell.T
ClcT.E
Clot.E
CmpT.?
Cell temperature
Calculation test error
Clot pressure abnormal
Unable to calculate comp. test (compensation test)
Data error in comp. test (compensation test) N
-
N
-
N
CmpT.E
>Curr
Curr.E
>Cuvet
Det.S
Edited
< >ISE
>I.H
>I.HI
>I.I
>I.L
>I.LH
>I.LHI
>I.LI
Inc.T
Table 25-9
Current range over
Current range check error
ABS Cell blank abnormal
Carry over detergent short
Edited test
ISE range over
Serum index interference hemolysis
Serum index interference hemolysis / icteric NR
Serum index interference icteric NR
Serum index interference lipaemia
Serum index interference lipaemia / hemolysis
Serum index interference lipaemia / hemolysis / icteric
Serum index interference lipaemia / icteric
Incubator temperature
Rerun list
-
-
-
-
NR
I
(1)
NR
NR
NR
NR
NR
-
Roche Diagnostics
Operator’s Manual · 4.2.1
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
Yes
NR
NR
NR
NR
NR
-
N
N
-
-
NR
-
NR
NR
NR
NR
NR
N
-
-
N
N
NR
-
NR
NR
NR
NR
NR
N
-
-
N
N
NR
-
NR
NR
NR
NR
NR
N
-
-
N
N
NR
c 701 c 702 c 502 e 602 Auto rerun
N
-
N
N
D
N
-
-
-
N
-
N
N
-
N
N
D
N
-
-
-
N
-
N
-
-
D
N
N
N
N
-
-
N
-
N
N
N
-
-
N
N
N
N
N
N
N
-
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
NR
NR
-
NR
NR
-
NR
NR
-
NR
NR
N
No
No
Yes
873
25 Data alarms
Rerun list cobas® 8000 modular analyzer series
Flag Alarm ISE c 701 c 702 c 502 e 602 Auto rerun
ISE.E
ISE.N
>Kin
>Lin
MIXLOW
MIXSTP na.LHI
OBS.RM
ISE voltage level error
ISE noise error
Kinetic unstable (Prozone error 2)
Linearity abnormal
Mixing current low
Stop mixing
Serum index measurement not performed
On-board stability limit over on reagent manager
N
N
-
-
N
N
NR
-
-
-
D
N
N
N
NR
-
-
-
D
N
N
N
NR
NR
-
-
D
N
N
N
NR
-
-
-
-
-
-
-
NR
-
Yes
Yes
Yes
Yes
Yes
Yes
No
No
OBS.RR
Over.E
>Proz
>React
ReagEx
Reag.F
Reag.H
Reag.S
On-board stability limit over on reagent rotor -
Overflow
Prozone error
Reaction limit over
Reagent expired date
Reagent film detection
Reagent hovering
Reagent short
-
-
-
-
-
-
N
NR
NR
D
D
NR
-
-
N
NR
NR
D
D
NR
-
-
N
NR
NR
D
D
NR
-
-
N
NR
NR
-
-
NR
N
N
N
No
No
Yes
Yes
No
Yes
Yes
No
Reag.T
>Rept / <Rept
Reagent disk temperature
Repeat limit over (upper) / (lower)
ABS maximum over (non-lin curve)
Sample air bubble
Sample clot
Sample carry over for modules
Sample short
Minimum signal
Sample LLD abnormal
-
N
-
-
N
-
-
NR
N
-
N
-
-
-
N
D
-
N
-
-
NR
N
-
N
D
-
N
-
-
NR
N
-
N
D
-
N
-
-
NR
N
N
N
-
N
N
N
N
NR
N
Yes
Yes/No due to setting
Yes Samp.?
Samp.B
Samp.C
Samp.O
Samp.S
<SigL
SLLD.E
SLLD.N
SysR.S
SysR.T
< >Test
>Test
Sample LLD noise
System reagent short
System reagent temperature
ISE sample range over
Technical limit over (upper)
-
-
-
-
D
-
-
-
-
D
-
-
-
-
D
N
-
N
N
D
Yes
No
No
No
Yes
Yes
Yes
Yes
Yes
No
Yes
<Test
WB.S
Technical limit over (lower)
Washing buffer short
N
(2)
N
-
(2) I
-
I
-
I
-
NR
N
ISE: Yes c 701: Yes c 702: Yes c 502: Yes e 602: No
Yes
WB.T
Washing buffer temperature N Yes
Table 25-9 Rerun list
(1) Increased sample volume for Na
+
and Cl
-
tests. This alarm is effective for urine samples only and is not applicable to K
+
tests.
(2) Normal sample volume for serum/pl samples. For urine samples it depends on the technical limit setting whether a rerun is requested with normal sample volume or whether this alarm is issued at all.
Roche Diagnostics
874 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Table of contents
Troubleshooting
26 Troubleshooting
26
This chapter provides general information about troubleshooting problems on the cobas 8000 instrument.
Roche Diagnostics
Operator’s Manual · 4.2.1
In this chapter
Chapter
26
Cannot access another software submenu......................................................... 882
Selecting samples to compare the reaction curves ........................................... 883
875
26 Troubleshooting
Table of contents cobas® 8000 modular analyzer series
Multiple photometric tests (more than 1 reagent pack)......................................... 894
Reagent gripper arm stopped during movement (c 702 only).............................. 896
Inter-assay precision (including both channels within 1 module) ....................... 903
Roche Diagnostics
876 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
General troubleshooting
General troubleshooting
This chapter provides general information about troubleshooting problems on the cobas 8000 instrument.
Troubleshooting procedures
To identify and isolate problems effectively, you must understand the theory of operation, operating procedures, emergency procedures and test reaction descriptions covered in this manual. The following areas are covered:
Application problems o
Photometric, immunoassay or ISE o
Reagents o
Samples, controls or calibrators o
Operator error
Instrument problems o
Electrical/electronic o
Mechanical o
Operator error
Computer problems o
Problems during download procedure, incorrect parameters o
System parameter reading o
Operator error
Facility problems o
Heat o
Humidity o
Power supply o
Water supply o
Drain
Operator's primary responsibility o
Reagent, calibrator and control preparation and storage o
Sample preparation o
Instrument mechanical alignments and adjustments o
Computer parameters and general computer input/output operations o
Basic component replacement o
Basic operator technique, including computer operation o
Maintenance q The basic operator is not responsible for troubleshooting electrical problems except as covered in this part of the Operator’s Manual: Do not attempt removal of printed circuit boards unless specifically instructed to do so by a Roche Diagnostics representative.
When troubleshooting, observe and record the alarms and isolate the problem to the area denoted by the alarms. In many cases, you may be able to find the problem, correct it and then resume processing. The remainder of this chapter provides instructions and guidelines to aid in isolating problems.
Roche Diagnostics
Operator’s Manual · 4.2.1
877
26 Troubleshooting
General troubleshooting cobas® 8000 modular analyzer series
Calling technical support
If it becomes necessary to consult technical support to troubleshoot a test or instrument problem, be prepared with the following information: u
The items are divided into the following categories:
Chemistry problem o
Account number/customer ID number o
Instrument serial number o
Module type and serial number o
Software version o
Description of the problem including relevant alarm(s) and alarm code numbers o
Test(s) affected and other tests on board o
Special wash programming o
Catalog number, lot numbers and expiration dates of reagents o
Catalog number, lot numbers and expiration dates of calibrators and controls o
Lot number of ISE electrodes o
Calibration absorbance values from the last few calibrations performed o
Control results from the last few controls performed o
Patient results (with correlation results, if relevant) o
Reaction Monitor report for affected test(s)
Immunoassay problem o
Account number/customer ID number o
Instrument serial number and module serial number o
Software version o
Description of the problem including relevant alarm(s) and alarm code numbers o
Is the problem module or channel specific o
One assay or more assays affected and other assays on board o
When problem first occurred o
Special wash programming o
Catalog numbers, lot numbers, and expiration dates of reagents o
Catalog numbers, lot numbers, and expiration dates of calibrators and controls o
Calibration results from the last few calibrations performed o
Control results from the last few controls performed o
Patient results (with correlation results, if relevant)
Instrument problem o
Account number/customer ID number o
Instrument serial number o
Software version and installed language o
Installation date of instrument and software
Roche Diagnostics
878 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
General troubleshooting o
Detailed description of the problem including any form of evidence (e.g., screen shots, photos, or printed data)
O
Frequency and circumstances of occurrence
O
Alarm(s) and alarm code numbers
O
Alarm trace of the date in question o
Other instrument or maintenance related information
Roche Diagnostics
Operator’s Manual · 4.2.1
879
26 Troubleshooting
Instrument troubleshooting
Instrument troubleshooting
cobas® 8000 modular analyzer series
This chapter provides information about troubleshooting procedures for the system as a whole. Procedures for troubleshooting general instrument problems as well as problems during power up are described.
Troubleshooting at Power Up
Conditions that can affect instrument power up are presented in the table below.
To troubleshoot a problem, determine the category below that best describes the problem, and follow the recommended remedy. If all remedies are unsuccessful, call technical support.
NOTICE
PROBLEM: The instrument does not power up when the operation power switch (on the front side of the core unit) is pressed.
Damage to the instrument due to improper power connection r The instrument must only be connected to a power supply source with the specified power cord and by trained personnel.
r Always make sure that the power switch is in the off position before plugging in the instrument.
o
Cause or description o
Instrument is unplugged.
o
Main circuit breaker (on the rear side of rack sampler unit) in OFF position.
o
Module power switch for one of the modules is switched off.
o
The circuit breaker for the instrument power line in your facility is in the OFF position.
Control unit workstation power cord is unplugged at the rack sampler unit.
Table 26-1 Troubleshooting at power up
Remedy
Plug instrument power cord into socket.
Switch main circuit breaker to the ON position.
Switch on the module power switch.
Have your facility electrician check the appropriate circuit breaker.
Plug the power cord into the rack sampler unit. If the instrument still does not power up, call technical support.
General instrument troubleshooting
This chapter provides information about troubleshooting procedures for general instrument problems.
To troubleshoot a problem, determine the category below that best describes the problem, and follow the recommended remedy. If all remedies are unsuccessful, call technical support.
Roche Diagnostics
880 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Instrument troubleshooting
General mechanical problem isolation
The control unit controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately recognized by the system. The alarm indicator on the global Alarm button lights up, alerting you to the problem. Touch Alarm (global button) to display the Alarm window with the specific alarm code, date and time the alarm occurred and a description of the alarm. Touch a specific alarm to display the alarm details and appropriate remedy.
For certain problems affecting the instrument performance, the system terminates the operation mode and enters the S. Stop (sampling stop) or Stop mode. In the
S. Stop mode, the system allows completion of the samples in process unaffected by the failure. If the problem affects all samples in process, the computer immediately terminates the operation mode with a Stop or E. Stop (emergency stop).
CAUTION
Incorrect results or damage to the instrument due to unrecognized instrument problems
Certain instrument problems may arise that the instrument does not monitor. If this is the case, no alarm will be issued to alert the operator. Such problems may include worn parts, air leaks in the syringe system, reagent contamination, etc. r When you encounter these types of problems, you must decide whether to continue to process samples or terminate the operation, depending on the possibility of causing damage to the instrument or reporting erroneous test results.
Electrical power not available
If you are having problems powering the instrument on, follow this procedure: p To troubleshoot problems with the electrical power
1 Are the operation ON/OFF switch and circuit breaker switched OFF?
o
If yes, then go to step
o
If no, then go to step
2
Switch on both power switches.
3
Is the power cable plug disconnected at either the instrument or the outlet?
o
If yes, then go to step
o
If no, then go to step
4 Firmly connect the power cable.
5 Is the main power outlet working?
o
If yes, then go to step
o
If no, then go to step
6
Check the circuit breaker in the laboratory distribution box.
7
Ensure line voltage is adequate.
8
If you are still experiencing problems, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
881
26 Troubleshooting
Instrument troubleshooting cobas® 8000 modular analyzer series
Cannot access another software submenu
If you are unable to access another software submenu, follow this procedure: p To troubleshoot problems accessing another software submenu
1
Power OFF the instrument at the circuit breaker.
2
Check the cabling between the touchscreen and the instrument.
3
Power ON the instrument at the circuit breaker. If you are still unable to access another submenu, call technical support.
s
Touchscreen does not come on
If you are having problems with the touchscreen, follow this procedure: p To troubleshoot problems with the touchscreen
1 Is the operation ON/OFF switch on the front of the touchscreen switched OFF?
o
If yes, then go to step
o
If no, then go to step
2
Switch the operation switch ON.
3
Is the cable between the touchscreen and the instrument disconnected?
o
If yes, then go to step
o
If no, then go to step
4 Firmly connect the cable.
5 If you are still experiencing problems, call technical support.
s
Touchscreen is difficult to see
If the content of the touchscreen is difficult to see, follow this procedure: p To troubleshoot problems with the touchscreen
1
Is the touchscreen dirty?
o
If yes, then go to step
o
If no, then go to step
2 Gently wipe the surface with a dry cloth.
3 Is the ambient lighting too bright?
o
If yes, then go to step
o
If no, then go to step
4
Either reduce the brightness of the ambient lighting or change the direction of the monitor.
5
If you are still experiencing problems, call technical support.
s
Roche Diagnostics
882 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Instrument troubleshooting
Probes do not descend to liquid surface
If the sample probes do not descend to the liquid surface, follow this procedure: p To troubleshoot problems with the descending of the probes
1
Are there bubbles on the liquid surface?
o
If yes, then go to step
o
If no, then go to step
2 Eliminate the bubbles in the sample container with a cotton swab.
3 Did the probe tip touch something during descent?
If yes, remove the obstacle.
s
Selecting samples to compare the reaction curves
With the Overlay window you may select up to 5 samples or controls of a specific test to compare the reaction curves. The results show the relationship from one sample or control to another for a given test. This can assist in troubleshooting potential system or sample problems.
p Comparing reaction curves of up to 5 samples for a specific test
1
Choose Workplace > Data Review > Reaction Monitor > Overlay .
2
Select a sample to be added to the lower list.
3
Select a symbol in the lower list.
4
Choose the Add button to add this sample to the lower list.
The symbol is displayed in the upper list box in the Assort column.
5
to select further samples. Up to 5 samples can be selected to overlay.
The reaction graphs then overlay each other and display on the Reaction
Monitor window.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
883
26 Troubleshooting
Troubleshooting (cobas ISE module)
Troubleshooting (cobas ISE module)
cobas® 8000 modular analyzer series
This chapter provides information about troubleshooting procedures specific to the
ISE module.
Only one test shows erratic results
p Only one ISE channel shows erratic results on one or more samples
1
Check if the wrong sample container was used (for example, heparin sample tubes).
2
Check for contamination of sample containers.
s p Only one ISE channel shows erratic results that are not repeated
1 Check for small air bubbles in the ISE REF, ISE DIL and or ISE IS reagent lines.
o
If bubbles are present, choose Utility > Maintenance and perform
(8) Reagent Prime (All).
o
If bubbles are still visible, check if reagents were allowed to reach room temperature before being used.
2
Check if the signal cable connection of the affected channel is loose or has a salt bridge.
o
If a salt bridge is present, check the electrode compartment for leaks.
o
If only 1 ISE channel shows erratic results on all samples, follow the next steps of this procedure.
3 Check for contamination and use of the correct sample containers.
4 Perform a calibration and QC.
If the calibration and QC data of the affected channel show irregularities and/or data flags, follow the remedy described in the Data Flags list.
s
All results are erratic, excessive air in sipper syringe
p Problems with erratic ISE results and excessive air in the sipper syringe
1
Check reagent volumes in reagent containers. Are reagent volumes sufficient and is the ISE REF reagent line in the bottle?
If no, replenish reagent. Make sure the ISE REF reagent line is at the bottom of the bottle. Choose Utility > Maintenance and perform (8) Reagent Prime on the ISE module; select All and enter 20 cycles.
2
Is the system leaking?
If yes, check all tubing and connections for leaks. Tighten loose fittings. Check seals of the ISE and sipper syringes.
Choose Utility > Maintenance and perform (8) Reagent Prime on the ISE module; select All and enter 20 cycles.
Roche Diagnostics
884 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas ISE module)
3 Check position of the measuring electrodes. Are the measuring electrodes placed properly?
If no, place the electrodes in correct position. Choose Utility > Maintenance and perform (8) Reagent Prime on the ISE module; select All and enter 20 cycles.
4 Check reference electrode placement. Is the reference electrode placed properly?
If no, place the electrode in its proper position. Choose Utility > Maintenance and perform (8) Reagent Prime on the ISE module; select All and enter 20 cycles.
5 If problem recurs, call technical support.
s
Results are erratic
p Problems with erratic ISE results
1
Is the ISE REF reagent line correctly placed in the bottle?
If no, check line placement, prime reagents and rerun samples.
2
Is there salt buildup on electrodes or syringes or are there any loose connections?
If yes, tighten any loose or leaky connections, then clean all salt buildup with wet gauze and rerun samples.
3
Check sipper line tubing for kinks or occlusions and remove them.
4
Perform maintenance check (2) ISE Check (30 cycles).
The measured voltage for Ref. is allowed to be within -7 mV to +7 mV. The maximum deviation for the entire cycle range should be no more than ± 2 mV.
The measurement-to-measurement difference within the 30 cycle interval should not be greater than 0.2 mV for Na, K, and Cl.
If results are not within range, replace ISE reference electrode. Choose Utility
> Maintenance and perform (8) Reagent Prime on the ISE module; select All and enter 20 cycles. Then, recalibrate and rerun samples.
5
Are there air bubbles in the sipper syringe?
If yes, replace seal in the sipper syringe and prime the ISE IS reagent. Choose
Utility > Maintenance and perform (8) Reagent Prime on the ISE module (IS).
6
Verify microbial growth is not present in the reagent system. If necessary, clean the ISE reagent flow path.
u
See
Processing green wash rack (p. 646).
7
If problem recurs, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
885
26 Troubleshooting
Troubleshooting (cobas ISE module)
High/low internal standard values
cobas® 8000 modular analyzer series p Problems with high/low ISE internal standard values
1
Is the measured voltage for ISE IS and the ISE IS concentration value higher than normal?
The measured voltage for ISE IS deviated ± 2 mV maximum from the mean value between the Standard Low and Standard High. The ideal concentration of the
Internal Standard is:
Na
+
: 130–150 mmol/L
K
+
: 4.6–5.4 mmol/L
Cl
-
: 90–110 mmol/L o
If yes, go to step
or, o
If no, go to step
2 Check that the ISE IS is correctly placed on the system.
Replace ISE reagents if required.
u
For information about replacing ISE reagents, see:
Replacing reagents (cobas ISE module) (p. 341)
3 Check that fresh ISE calibrators are used and that they are placed in the correct positions of the calibrator rack.
Replace ISE calibrators if required.
4 Check the ISE sipper syringe assembly. Are there leaks?
If yes, please call your Roche service representative.
5
Perform maintenance check (2) ISE Check.
The measured voltage of the reference electrode must be between -7 mV and
+7 mV. The maximum deviation for the entire cycle range should be no more than ± 2 mV.
o
If all values (Na
+
, K
+
, and Cl
-
) are too high or too low, replace the reference electrode. An ISE.E data alarm is displayed in the printout adjacent to the respective measured voltage if the following limits are exceeded:
Na
+
: -90 to -10 mV
K
+
: -90 to -10 mV
Cl
-
: 80 to 160 mV o
If only single values (Na, K or Cl) are outside the range, replace the respective electrode.
6 If problem recurs, call technical support.
s
Roche Diagnostics
886 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas ISE module)
High sodium or low chloride values
p Problems with high sodium and low chloride values
1
Were fresh low and high calibrators used?
If no, recalibrate with fresh calibrators and rerun the samples.
2
Prepare fresh ISE IS and ISE DIL reagents.
o
Replace the old ISE IS and ISE DIL reagents with the fresh reagent.
o
Prime the fresh reagent: Choose Utility > Maintenance and perform
(8) Reagent Prime on the ISE module; select All and enter 20 cycles.
o
Recalibrate two times with fresh reagents and calibrators.
o
Rerun the sample.
3 If problem recurs, call technical support.
s
Low ISE values
p Problems with low ISE values
1
Were fresh low and high calibrators used?
If no, recalibrate with fresh calibrators and rerun the samples.
2
Were fresh ISE reagents used?
If no, prepare fresh ISE IS and ISE DIL o
Replace the old ISE IS and ISE DIL reagents with the fresh reagent.
o
Prime the fresh reagent: Choose Utility > Maintenance and perform
(8) Reagent Prime on the ISE module; select All and enter 20 cycles.
o
Recalibrate two times with fresh reagents and calibrators.
o
Rerun the sample.
3 Is the correct compensator value (ISE High (S3)) entered under Calibration
> Status > Chemistry ?
If no, correct the compensator value.
4 If problem recurs, call technical support.
s
Bubbles in syringes
If you see bubbles in either the reagent syringes and/or sample syringe, follow the corresponding procedure: p To troubleshoot problems with bubbles in ISE IS, ISE DIL or ISE REF syringes
1
Choose Utility > Maintenance and select (8) Reagent Prime on the
Maintenance Items list.
2
Select All from the Prime Item box and enter 20 cycles.
Roche Diagnostics
Operator’s Manual · 4.2.1
887
26 Troubleshooting
Troubleshooting (cobas ISE module) cobas® 8000 modular analyzer series
3 If there are still bubbles in the syringe, repeat this process for the syringe concerned.
If bubbles remain in the syringe after the second pipetter prime, call technical support.
s p To troubleshoot problems with bubbles in the sample syringe
1
Choose Utility > Maintenance and select (6) Air Purge on the Maintenance
Items list.
2
Select the ISE module and choose Execute .
3
If there are still bubbles in the syringe, repeat this process.
If bubbles remain in the syringe after the second air purge, call technical support.
s
Roche Diagnostics
888 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (photometric modules)
Troubleshooting (photometric modules)
This chapter provides information about troubleshooting procedures specific to the c 701 / c 702 and c 502 modules.
High test results
The following may cause high test results on photometric modules. Identify the module(s) giving high test results and follow this procedure: p To troubleshoot problems with high test results
1
Incubator bath temperature is incorrect.
o
If the bath temperature does not read 37 ± 0.1 °C, call technical support.
2
Poor calibration results.
o
Check calibrator preparation.
o
Check proper calibration programming and calibration results. Repeat calibration if necessary.
3 Calibrators were not properly prepared.
o
Check calibrator preparation and calibration results. Repeat calibration.
4 Evaporation of sample, calibrator or control.
o
Repeat analysis with fresh sample, calibrator and/or control.
If calibrators and controls have been loaded on the racks for more than
2 hours, evaporation of calibrator may lead to lower results for patient samples.
5 Reagents were not properly prepared.
o
Check reagent preparation and expiration date.
6 Information is not correct on Calibration > Install .
o
Verify the calibration points on Calibration > Install and compare the displayed data with the documentation for a specific test.
o
Verify the calibration sample volume in the application parameters.
7
Incorrect sampling or dilution of sample.
o
Check correct assembly of sample probe and pipetter parts.
o
Check all fittings and syringes for leaks. If there are leaks, please call your
Roche service representative
8 Insufficient reagent volume.
o
Check reagent pipetting system for leaks.
o
Replace reagent pack and repeat analysis.
9
If you are still experiencing problems, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
889
26 Troubleshooting
Troubleshooting (photometric modules)
Low test results
cobas® 8000 modular analyzer series
The following may cause low test results on photometric modules. Identify the module(s) giving low test results and follow this procedure: p To troubleshoot problems with low test results
1
Reagents are expired.
o
Prepare new reagents (see Instructions for Use for the stability of the prepared reagent).
2
Reagents were not properly stored.
o
Prepare new reagents (see Instructions for Use for proper storage).
3
Reagents were not properly prepared.
o
Prepare new reagents (see Instructions for Use for proper preparation instructions).
4
Incubator bath temperature is incorrect.
o
If the bath temperature does not read 37 ± 0.1 °C, call technical support.
5
Calibrators were not properly prepared.
o
Check calibrator preparation and repeat the calibration with fresh calibrators.
6
Information is not correct on Calibration > Install .
o
Check Calibration > Install and compare the displayed data with the documentation for a specific test.
o
Verify the calibration sample volume in the application parameters.
7 Ensure there is sufficient sample in the container. Check instrument specifications for minimum sample volumes.
8 Check sample for fibrin clotting.
9 Check sample pipetting systems for leaks and air bubbles.
10 Check sample probe for contaminants and obstructions.
11 Repeat analysis with appropriate sample volume.
12 Check if the cell rinse nozzles are dripping.
13 Check that ultrasonic mixers are operating properly.
14 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
890 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (photometric modules)
Erratic test results
The following may cause erratic test results on photometric modules. Identify the module(s) giving erratic test results and follow this procedure: p To troubleshoot problems with erratic test results
1
Fibrin clot in 1 sample container or in sample probe (if low values printed for several samples).
o
Check sample for fibrin clot; remove fibrin and repeat analysis.
o
Check sample probe for fibrin clot; clean probe (perform maintenance item
(18) Sample Probe Wash and perform an air purge.
u
See also
Cleaning the pipetter probes (p. 693).
o
Replace sample probe and sample probe seal.
2 Sample probe does not reach the bottom of the reaction cell when dispensing sample.
o
Perform mechanism check and verify that the probe reaches the bottom of the cell.
o
Check the spring mechanism to make sure the probe moves up and down freely.
o
The sample probe tip may be damaged. Replace the sample probe.
3 Maintenance was not performed properly or at the recommended intervals on sample or reagent pipetters or probes.
o
Check the Maintenance submenu and perform any overdue maintenance functions.
If maintenance was recently performed on the sample probe(s), reagent probe(s), rinse nozzles, or any pipetters: o
Was an air purge performed after maintenance?
o
Were all parts correctly assembled?
o
Have all tubing and seals been checked for air leaks?
o
Were sample and reagent probe seals replaced?
4
Insufficient sample volume.
o
Repeat analysis with sufficient sample.
5
Contaminated incubator bath.
o
Check for particles in the incubator bath. If particles exist, perform the incubation cleaning procedure.
u
See:
Replacing reaction cells and cleaning incubator bath (p. 713).
o
Check for foaming, perform maintenance item (5) Incubation Water
Exchange.
o
Check that the remaining volume of Ecotergent on the module is sufficient.
Perform incubation water exchange.
6 Check for sufficient volumes of cell cleaning detergents.
7 Check the cell rinse unit for contamination and clean the nozzles if necessary.
u
For more information, see
Cleaning cell rinse nozzles (p. 699)
Roche Diagnostics
Operator’s Manual · 4.2.1
891
26 Troubleshooting
Troubleshooting (photometric modules) cobas® 8000 modular analyzer series
8 If you are still experiencing problems, call technical support.
s
Erratic or biased test results
For problems with erratic or biased test results on photometric modules, identify the module(s) having problems and follow this procedure: p To troubleshoot problems with erratic or biased test results
1
Verify that the deionized water supply is free from contamination.
2
Check calibrators used on all modules.
o
Calibrators were not properly prepared. Repeat calibration with fresh calibrator.
o
Check calibrator preparation.
3 Information is not correct on Calibration > Install .
o
Verify the calibration points on Calibration > Install and compare the displayed data with the documentation for a specific test.
o
Check that the calibration sample volume in the application parameters is correct.
4
Check sample for fibrin clotting.
5
Ensure there is sufficient sample in the container. Check instrument specifications for minimum sample volumes.
o
Repeat analysis with appropriate sample volume.
6
If you are still experiencing problems, call technical support.
s
Bubbles in syringes
If you see bubbles in any of the syringes of a photometric module, follow this procedure: p To troubleshoot problems with bubbles in the syringes
1 Choose Utility > Maintenance and select (6) Air Purge on the Maintenance
Items list.
2 Select the desired module.
3 In the Syringe area, select the syringe to be purged of air (or all syringes).
4 If there are still bubbles in the syringe, repeat this process for the syringe concerned.
If bubbles remain in the syringe after the second air purge, call technical support.
s
Roche Diagnostics
892 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (photometric modules)
Single sample or control
For problems with a single sample or control on photometric modules, identify the module(s) having problems and follow this procedure: p To troubleshoot problems with a single sample or control
1
Verify samples and controls are placed in the proper rack and positions. If necessary, correct the sample or control placement and rerun the sample.
2
Verify the control value ranges and lot numbers entered on QC > Install are correct. If necessary, correct the control value range or lot number on QC
> Install .
3
Verify the sample and/or control volume is sufficient. Verify the selected sample cup on Workplace > Test Selection .
4
Verify the sample integrity is acceptable (fibrin, lipemia, hemolysis, icterus). If necessary, collect fresh sample and rerun.
5
Verify the appropriate sample type is selected (serum/plasma, CSF, urine, supernatant, other) and the sample is collected appropriately. If necessary, correct the sample type; check the Instructions for Use for acceptable sample types.
Check the sample collection; check the Instructions for Use for acceptable sample collection methods.
6
Verify the collection time and date of the sample are correct. If necessary, collect fresh sample.
7
Verify correct test selections were made on Workplace > Test Selection . If necessary, correct selections and rerun the sample.
8
If you are still experiencing problems, call technical support.
s
Single test (1 reagent pack)
For repeated or consistent problems with a single test on photometric modules, identify the module having problems and follow this procedure: p To troubleshoot problems with a single test (1 reagent pack)
1 Verify that reagents have not expired or are not contaminated or discolored. If necessary, insert a new reagent pack.
2 Verify the correct calibrator code and setpoints are used. If necessary, correct the calibrator code and setpoints and repeat the calibration.
3 Verify the special wash programming, if applicable.
4 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
893
26 Troubleshooting
Troubleshooting (photometric modules)
Tests with more than 1 calibration point
cobas® 8000 modular analyzer series
For problems with tests with more than 1 calibration point on photometric modules, identify the module(s) having problems and follow this procedure: p To troubleshoot problems of tests with more than 1 calibration point
1
Verify calibrators were properly prepared and stored. If necessary, prepare new calibrators and recalibrate.
2
Verify the assigned calibrators are in the correct positions. If necessary, place calibrator(s) in correct position(s), recalibrate and rerun samples. Verify that required diluents are on board.
3
If you are still experiencing problems, call technical support.
s
Multiple photometric tests (more than 1 reagent pack)
For problems with multiple photometric tests on photometric modules, follow this procedure: p To troubleshoot problems with multiple photometric tests (more than
1 reagent pack)
1 Verify there are sufficient volumes of special wash solutions and detergents. If necessary, replace special wash solutions, detergent and rerun samples needed.
2 Check the reagent probes for barbs, obstructions or leaks.
3 Verify the R1 system is not leaking. Perform an air purge. If the system is leaking, check connections in the R1 probe arm and check connections in the R1 syringe(s).
4 Verify the incubator bath is free of debris and foam. If necessary, perform maintenance item (10) Incubator Bath Cleaning.
5 Perform a photometer check. Verify the Photometer Check report is within acceptable limits (< 14 000). If it is not, replace the photometer lamp. Perform a cell blank. Calibrate all photometric tests.
6 Verify the R2/3 probe(s) is aligned properly. If necessary, perform a reagent probe check.
7 Verify the R2/3 probe system(s) is not leaking. Check connections in the R2/3 delivery system(s). Check syringe connections. Perform an air purge.
8 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
894 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (photometric modules)
All photometric tests
For problems with photometric tests on photometric modules, identify the module(s) having problems and follow this procedure: p To troubleshoot problems with all photometric tests
1
Verify the sample probe(s) is not blocked or does not have barbs at the tip. If necessary, clean or replace the probe(s). Perform an air purge.
2
Verify the sample system(s) is not leaking. If necessary, check tubing and connections. Perform an air purge and check if there are air bubbles in the syringe.
3
Verify controls/calibrators were properly prepared and stored. If necessary, prepare new controls/calibrators.
4
Check that ultrasonic mixers are operating properly.
5
If you are still experiencing problems, call technical support.
s
Biased enzyme results
For problems with biased enzymes on photometric modules, identify the module(s) having problems and follow this procedure: p To troubleshoot problems with biased enzymes
1 Verify the incubation water level is above the photometer lens.
2 Verify the incubator bath temperature displayed on the Overview menu is
37 ± 0.1 °C. Verify there is no Incubation Bath Temperature alarm present.
If the temperature is out of range, perform an incubation water exchange, allow the temperature to stabilize and recheck the bath temperature. If the temperature is still unacceptable, call technical support.
3 Verify the sample and reagent syringe seals are in good condition.
If no, please call your Roche service representative for replacement.
4 Verify the syringe fittings are not loose. If necessary, correct any loose fittings.
5 Verify controls were prepared using volumetric pipettes. If not, prepare new controls using a volumetric pipette.
6 Perform a full calibration or blank update.
7 Perform a photometer check. Verify the Photometer Check report is within acceptable limit (< 14 000). If not, replace the photometer lamp. Perform a cell blank. Calibrate all photometric tests.
8 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
895
26 Troubleshooting
Troubleshooting (photometric modules) cobas® 8000 modular analyzer series
Reagent gripper arm stopped during movement (c 702 only)
The home position of the c 702 reagent gripper arm is the leftmost position of the module. If the system has stopped during operation for some reason and the gripper arm stopped somewhere other than at the home position, perform the following procedure. Otherwise, the module will not resume operation and an alarm will be issued.
p To move the gripper arm to its home position
1
Verify that the entire analyzer is in Standby or the c 702 module is masked.
2
Open the top cover of the module.
3
Manually move the gripper either to the leftmost or the rightmost position of the module.
4
Close the top cover.
5
Restart operation.
s
Roche Diagnostics
896 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas e 602 module)
Troubleshooting (cobas e 602 module)
This chapter provides information about troubleshooting procedures specific to the e 602 module.
Reagent disk cover does not open/close
If you are having problems opening or closing the reagent disk cover, follow this procedure: p To troubleshoot problems opening or closing the reagent disk cover
1
The reagent disk cover is keyed. Is the reagent disk cover properly oriented for placement?
o
If yes, then go to step
o
If no, then go to step
2 Make sure that the reagent disk cover fits into the key before locking.
3 Is there an obstacle around the cover?
o
If yes, then go to step
o
If no, then go to step
4
Remove the obstacle.
5
If you are still experiencing problems, call technical support.
s
Trouble replacing ProCell/CleanCell
If you are having problems replacing a ProCell or CleanCell reagent bottle, follow this procedure: p To troubleshoot problems replacing a ProCell or CleanCell reagent bottle
1 The auxiliary reagent bottles are keyed for proper placement. Are you placing the bottle in its appropriate position?
o
If yes, then go to step
o
If no, then go to step
2
Remove the bottle and check the position before placing the reagent in its proper place.
3
Is there an obstacle beneath the auxiliary reagent bottle?
o
If yes, then go to step
o
If no, then go to step
4 Remove the obstacle.
5 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
Operator’s Manual · 4.2.1
897
26 Troubleshooting
Troubleshooting (cobas e 602 module)
Trouble replacing PreClean
cobas® 8000 modular analyzer series
If you are having problems replacing a PreClean reagent bottle, follow this procedure: p To troubleshoot problems replacing a PreClean reagent bottle
1
Ensure PreClean bottles are fully inserted.
2
Ensure the caps have been slightly opened after insertion.
3
If you are still experiencing problems, call technical support.
s
Drift
Control or sample shows drift over a period of time
Causes o
Evaporation or incorrect storage conditions of cobas e packs.
o cobas e packs are not at the proper temperature.
o
Recommended calibration frequency not used.
o
Recommended handling of controls and/or samples not followed (stability and evaporation).
p To troubleshoot problems with drift of controls or samples
1
Did you handle the reagents, calibrators, and/or controls according to the
Instructions for Use?
2
Perform recommended maintenance.
3
If you are still experiencing problems, call technical support.
s
Erratic test results
Causes o
Foam on sample o
Foam on assay reagents o
Foam on controls o
Non-recommended sample container used p To troubleshoot problems with erratic test results
1
Did you handle the reagents, samples, and controls according to Instructions for
Use?
2
Perform the recommended maintenance.
3
If you are still experiencing problems, call technical support.
s
Roche Diagnostics
898 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas e 602 module)
Bubbles in syringes
If you see bubbles in any of the syringes, follow this procedure: p To troubleshoot problems with bubbles in syringes
1
Choose Utility > Maintenance and select (36) System Air Purge (e602) on the
Maintenance Items list. Select both measuring channels and enter 1 cycle.
If only one syringe is affected, you may also select the corresponding air purge: o
(22) Pipetter Air Purge o
(23) Sipper Air Purge o
(30) Pre-wash Sipper Air Purge
2
Choose Utility > Maintenance and select (37) System Prime (e602) on the
Maintenance Items list. Select the desired e 602 module and enter 1 cycle.
3
If there are still bubbles in the syringe, repeat this process.
If bubbles remain in the syringe after (36) System Air Purge (e602) and
(37) System Prime (e602) were performed two times, call technical support.
s
Assay calibration
This section provides information about troubleshooting procedures for problems with assay calibration.
To resolve a problem, determine the category below that best describes the problem and follow the recommended remedy. If all remedies are unsuccessful, call technical support.
Calibration cannot be performed
Causes o
Calibrator vial previously used on the instrument.
o
More than 4 calibrations out of one vial (calibrators can be pipetted up to 4 times from the same vial).
o
The cobas e pack or calibrator not on board.
o
Calibrator is not installed in the software.
o
Calibrator expiration date exceeded.
o
Invalid or unreadable calibrator vial barcode, or calibrator lot specific data not downloaded.
o
Data link not available for combination cobas e pack and CalSet.
o
CalSet 1 and CalSet 2 not on same rack or empty space between CalSets.
o
Barcoded vial placed in a rack with manually assigned positions.
p To troubleshoot problems with calibrations
1 Check barcode of calibrator vial and cobas e pack (barcode damaged?, correct position of the barcode?).
2 Check if calibrator lot specific data has been downloaded.
3 Wipe off the dust on the surface of the barcode reader.
Roche Diagnostics
Operator’s Manual · 4.2.1
899
26 Troubleshooting
Troubleshooting (cobas e 602 module) cobas® 8000 modular analyzer series
4 Dry the calibrator vial, if it is wet.
5 Check calibrator position.
6 If you are still experiencing problems, call technical support.
s
Calibration not released
Roche Diagnostics
900 u
For more information about not released calibration, see:
Duplicates out of limits (p. 900)
Monotony not fulfilled (p. 900)
Calibration factor out of limits (p. 901)
Duplicates out of limits
Causes Foam on calibrator or assay reagents.
p To troubleshoot problems with duplicates out of limits
1
Did you handle the reagents and calibrators according to the Instructions for Use?
2
Perform a new assay calibration (new CalSet).
3
Perform recommended maintenance.
4
If you are still experiencing problems, call technical support.
s
Monotony not fulfilled
Causes Calibrators not transferred to the correct barcoded calibrator vials.
p To troubleshoot monotony problems
1 Did you handle the reagents and calibrators according to the Instructions for Use?
2 Perform a new assay calibration (new CalSet).
3 If you are still experiencing problems, call technical support.
s
Missing values
Causes o
Empty calibrator.
o
Insufficient volume of calibrator or calibrators.
p To troubleshoot problems with missing values
1 Did you handle the reagents and calibrators according to the Instructions for Use?
2 Perform a new assay calibration (new CalSet).
3 If you are still experiencing problems, call technical support.
s
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas e 602 module)
Values out of limits
Values below minimum signal or signal difference between CalSet 1 and CalSet 2 or maximum signal out of limits (latest criteria valid for qualitative assays only).
Causes o
Possible causes in connection with reagent handling:
O cobas e pack not at correct temperature.
O cobas e pack not within allowed stability after opening.
O cobas e pack expiration date exceeded.
O cobas e pack stressed (storage or transport conditions not as recommended, for example, temperature, upright position).
O
Foam on assay reagents.
o
Possible causes in connection with calibrator handling:
O
Calibrator not at correct temperature.
O
Foam on calibrator
O
Calibrator handling not as recommended.
O
Calibrator transferred to the incorrect calibrator vial. For example, CalSet 1 transferred to CalSet 2 vial.
O
Calibrators not within allowed stability after opening and/or reconstitution.
p To troubleshoot problems with values out of limits
1 Did you handle the reagents, calibrators, and/or controls according to the
Instructions for Use?
2 Perform a new assay calibration (new cobas e pack or new CalSet).
3 Perform recommended maintenance.
4 If you are still experiencing problems, call technical support.
s
Calibration factor out of limits
Only valid for quantitative assays.
Causes o
Possible causes in connection with reagent handling:
O cobas e pack not at correct temperature.
O cobas e pack not within allowed stability after opening.
O cobas e pack expiration date exceeded.
O cobas e pack stressed (storage or transport conditions not as recommended, for example, temperature, upright position).
O
Foam on assay reagents.
o
Possible causes in connection with calibrator handling:
O
Calibrator not at correct temperature.
O
Foam on calibrator
O
Calibrator handling not as recommended.
O
Calibrator transferred to the incorrect calibrator vial. For example, CalSet 1 transferred to CalSet 2 vial.
O
Calibrators not within allowed stability after opening and/or reconstitution.
Roche Diagnostics
Operator’s Manual · 4.2.1
901
26 Troubleshooting
Troubleshooting (cobas e 602 module) cobas® 8000 modular analyzer series p To troubleshoot problems with calibration factor out of limits
1 Did you handle the reagents, calibrators, and/or controls according to the
Instructions for Use?
2 Perform a new assay calibration (new cobas e pack or new CalSet).
3 Perform recommended maintenance.
4 If you are still experiencing problems, call technical support.
s
Recovery of controls
Control values out of range
Causes o
Possible causes in connection with control handling:
O
Controls not at correct temperature.
O
Control not within allowed stability after opening or reconstitution.
O
Control expiration date exceeded.
O
Foam on controls.
O
Control handling not as recommended.
o
Possible causes in connection with reagent handling:
O cobas e packs not at correct temperature.
O cobas e packs not within allowed stability after opening.
O cobas e pack expiration date exceeded.
O cobas e packs stressed (storage or transport conditions not as recommended, for example, temperature, upright position).
O
Foam on assay reagents or auxiliary reagents.
o
Possible causes in connection with calibrator handling:
O
Recommended calibration frequency not followed.
p To troubleshoot problems with control values out of range
1 Did you handle the reagents, calibrators, and/or controls according to the
Instructions for Use?
2 Use another control vial.
3 Perform a new assay calibration (new cobas e pack and CalSet).
4 Perform recommended maintenance.
5 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
902 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series 26 Troubleshooting
Troubleshooting (cobas e 602 module)
Intra-assay precision
Intra-assay precision out of expected range
Causes o
Foam on assay reagents.
o cobas e packs and/or sample not at correct temperature.
o cobas e packs stressed (storage or transport conditions not as recommended, for example, temperature, upright position).
p To troubleshoot problems with intra-assay precision
1
Have you handled the reagents, calibrators, and/or controls according to the
Instructions for Use?
2
Perform recommended maintenance.
3
If you are still experiencing problems, call technical support.
s
Inter-assay precision (including both channels within 1 module)
Inter-assay precision out of expected range
Causes o cobas e packs and/or sample not at correct temperature.
o cobas e pack stressed (storage or transport conditions not as recommended, for example, temperature, upright position).
o
Foam on assay reagents.
o
Calibration not carefully carried out.
o
Recommended calibration frequency not followed.
p To troubleshoot problems inter-assay precision
1 Did you handle the reagents, calibrators, and/or controls according to the
Instructions for Use?
2 Perform recommended maintenance.
3 If you are still experiencing problems, call technical support.
s
Module to module variance
Deviation of control and samples when measured with different modules.
Causes o
Recommended handling of assay, auxiliary reagents and calibrators, controls not followed (for example, stability, evaporation).
o
Calibration not carefully carried out.
Roche Diagnostics
Operator’s Manual · 4.2.1
903
26 Troubleshooting
Troubleshooting (cobas e 602 module) cobas® 8000 modular analyzer series p To troubleshoot problems with the module to module variance
1 Did you handle the reagents, auxiliary reagents, calibrators, and/or controls according to the Instructions for Use?
2 Perform recommended maintenance.
3 If you are still experiencing problems, call technical support.
s
Method comparison
Deviation of method comparison when compared with competitors (internal, external)
Causes o
Different standardizations (reference material).
o
Different antibodies (for example, HCG on Elecsys).
o
Different methods (RIA/ELISA etc.).
o
Different units (conversion factor between units sometimes different from competitor to competitor).
o
Different sample material +/- anticoagulants.
o
Recommended calibration frequency not followed.
o
Calibration handling not as recommended.
o
The number of samples is too small and/or all results are within a very limited range compared to the measuring range of the assay.
o
Reagent lot to reagent lot variance.
o
System to system variance.
p To troubleshoot problems
1 Did you handle the reagents and calibrators according to the Instructions for Use?
2 Perform recommended maintenance.
3 If you are still experiencing problems, call technical support.
s
Roche Diagnostics
904 Operator’s Manual · 4.2.1
Glossary
cobas® 8000 modular analyzer series
Glossary
This glossary is a compendium in which to look up the meaning of technical terms used in conjunction with the cobas 8000 modular analyzer series.
2-dimensional barcode A type of barcode on cobas e packs, calibrators, and control barcode cards or sheets. These matrix barcodes, which use PDF417 symbology, contain more information than traditional linear barcodes.
absorbance (Abs) The instrument displays an absorbance by ten-thousandfold value.
aspiration station A position on the e 602 module located next to the incubator where an AssayCup containing the reaction mixture is placed for aspiration into the measuring cell by the sipper probe.
assay 1. A specific test.
2. The process of measuring a substance.
AssayCup A plastic vessel that is used to hold the assay reaction mixture. An alternative term is reaction vessel.
AssayTip A disposable pipette tip made of black, conductive plastic. AssayTips are used by the sample probe.
assigned value (Roche-defined) Roche-defined concentration for calibrator material that is encoded on the calibrator barcode card or e-barcode. See also
Automated Download (ADL) A service that provides the information necessary for analysis, for example analytical parameters or concentration information from the data center. ADL is a cobas TeleService application.
See also TeleService Net (p. 916).
automatic calibration 1. Automatic timeout calibration. A calibration of a parameter performed if a specified time interval expires. The calibration can be defined for each method separately.
2. Automatic calibration after a new reagent pack or a reagent pack of a new lot is registered. The calibration can be defined for each method separately.
3. Automatic calibration on QC failure. A calibration request is generated by the data manager if a QC value is outside a predefined range.
automatic QC A quality-control function that automatically samples QC material, test-specifically according to defined time intervals.
automatic rerun The repetition, without operator intervention, of tests that have results with data alarms.
Roche Diagnostics
Operator’s Manual · 4.2.1
2-dimensional barcode - calibration curve
27 auxiliary reagent A non-test specific reagent that is needed to perform testing on an instrument.
backup 1. The saving of data onto supplementary storage media such as DVDs. If such data is required again but is no longer available from the main storage
(instrument hard disk), it can be restored from a backup copy.
2. An internal instrument-specific process to establish the data for a backup; only used in a case of routine instrument break down.
backup operation A software function that allows to place routine racks with barcoded samples manually into a module sample buffer. Intended to be used when trouble occurs in the rack sampler and racks cannot be conveyed.
barcode mode The operational mode when a system is configured to operate using barcoded samples.
barcode type Typical sample barcode types used in the IVD industry are Code39, NW7 (Codabar), ITF, and
Code 128.
bichromatic measurement The measured absorbance of the primary wavelength and the secondary wavelength.
bound/free separation The physical separation of reagent or sample that is bound to a solid phase (the microbeads) from free reagent or sample. With ECL systems this step occurs in the measuring cell.
bridging principle One of three test principles that can be applied to ECL immunoassays. It is used to detect antibodies (such as IgG, IgM, or IgA) in the sample. See
also competitive principle (p. 909),
calculated test A test result calculated from different individual analytical methods with a given formula such as ratio A/B.
Calib. Now A system-generated recommendation to carry out calibration within a forthcoming defined time interval (Remaining time on Calibration > Status submenu).
calibration The process that establishes the relation between measured signals (e.g. from a photometer, photomultiplier, or ion-selective electrodes) and corresponding concentration values of a calibrator.
calibration curve A plot of measured signal values
(determined during calibration) versus known concentration values of calibrators.
907
cobas® 8000 modular analyzer series calibration factor - cobas c pack calibration factor 1. In ECL systems ( e 602), one of the six calibration quality criteria used to verify the validity of a calibration. This criterion is only used for cobas e pack calibrations. It is derived by comparing two different calibrations. A factor of 1.0 is achieved when two calibrations are equal. A successful calibration has a factor of 0.8–1.2.
2. In photometric systems ( c 701 / c 702 / c 502), the
K factor and S1Abs (linear calibration), and factors A, B,
C for non-linear calibration curves.
calibration frequency A specified interval at which an assay should be calibrated. Also referred to as calibration stability. It is implemented in the application parameters which are downloaded from the data manager or encoded in the reagent barcode of cobas e packs.
calibration function The type of calibration (for example, Rodbard function, linear function, or cutoff function). A mathematical model that describes the relationship between a signal and a concentration in the
calibration curve. See calibration curve (p. 907).
calibration masking A function that masks a reagent pack for a module or measuring channel when no valid calibration is available for this particular module or measuring channel.
calibration monitor A function that prints the measured absorbance of the standard solution and the calibration factors, at the time of calibration, for every measurement item.
calibration quality criteria Calibration checks applied to the auto-validation of every calibration on the instrument.
calibration trace A graph used to review the measurements of the 50 most recent calibrations for a specific test.
calibration type 1. In clinical chemistry: One of the following: Linear, RCM, RCM2T1, RCM2T2, Spline,
Line Graph. Each calibration type corresponds to one specific type of mathematical function. See
calibration function (p. 908).
2. General: Lot calibration or reagent pack calibration.
calibration validation Analysis, performed by software, to check a calibration data set against specific criteria. Calibration validation results are: successful or failed.
calibration verification The assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument kit or test system has remained stable throughout the laboratory's reportable range for patient test results (for example,
Elecsys CalChecks).
Roche Diagnostics
908 calibrator A material of known concentration of the parameter that can be presented to the analytical instrument for calibration purposes.
calibrator code The identification number of the standard solution in calibration measurement.
capacitance An electrical property that provides the basis for liquid level detection in sample probes. The probes carry a high-frequency, low-voltage electrical charge. Frequency and electrical charge characteristics are altered and sensed when the probe touches liquid.
carryover Contamination of a reaction mixture of one assay by reagents or sample material from another assay.
cassette See
cell blank The process of measuring the absorbance of all reaction cells, filled with water, at all wavelengths. The cell blank values are stored on the hard disk. By periodic cell blank measurement, reaction cells can be screened for contamination or damage.
cell holder A container holding the electrode in the electrode measuring unit.
cell rinse units A device for cleaning the reaction cells with detergent and water and for dispensing and aspirating cell blank water.
channel 1. The number of reagent positions on an analytical instrument.
2. A specific reagent position. check digit A verification number used in barcodes and software.
check sum The result of a mathematical procedure to validate the integrity of a set of data.
circuit breaker The main power switch on the instrument. It controls the power supply including the power to the Peltier elements. Consequently it controls the temperature in each reagent compartment, incubator, and detection unit.
cleaning solution See
client/server A network in which computer processing is distributed among many individual PCs
(clients) and a more powerful, central computer (server).
clot detection 1. A device built into the pipetting system to detect clots and to avoid false pipetting.
2. The procedure of detecting a clot.
cobas c pack The name given to a reagent pack used on cobas c modules and COBAS INTEGRA® systems.
See also reagent pack (p. 914).
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series cobas c pack MULTI The name given to an empty, but assembled and barcoded reagent pack that can be used for Roche or non-Roche reagents. The word multi in this name stands for multi-purpose.
cobas e pack The name given to a reagent pack used on cobas e modules and Elecsys® systems. See also
cobas link The infrastructure of network connections that enables to exchange information between the Roche
TeleService Net (TSN) and a customer's laboratory.
cobas link data station A specific desktop computer, located in the laboratory, that has been configured to act as a gateway between Roche systems and the Internet. As well as providing a communication link, the data station also stores data and documentation for assay processing and can provide a data archive.
cobas® The umbrella brand name for a broad range of products and services for use in professional IVD laboratories and physician's office settings.
Code39 A barcode type for sample tubes that can be read by the barcode reader.
coefficient of variation A statistical measure used to describe imprecision. Often abbreviated to CV.
compensated test A test that has the result modified by a formula.
competitive principle One of three test principles that can be applied to ECL immunoassays. It is used to detect analytes of low molecular weight (for example,
FT3). See also
conditioning The process of letting serum-type liquid flow through the flow path and the electrodes before electrolyte measurement.
consumables A generic term for items that are used during test processing and must be replaced on a regular basis by the operator. Examples of consumables include
AssayCups, printer paper, and reaction cells.
consumables area The area of an instrument where the consumables, such as AssayCups and AssayTips, are stored.
continuous loading/access Instrument function that allows loading of samples and reagents during operation.
control ID The abbreviated name for a control material, for example PC U1 or PC TSH. Control IDs are used on software submenus and windows where limited space prevents the use of longer names.
cobas c pack MULTI - demographics control material A material used to assess the performance of an analytical procedure or part of an analytical procedure. Also called the control sample.
control name The name of a control material, for example PreciControl Universal.
control SD value The acceptable variation SD value of a quality control sample.
control unit An external PC by which an analytical system is controlled. The control unit also serves as the user interface.
core unit The backbone of modular instruments for sample transportation.
correction item A function that corrects the measurement result of one item by using figures or the measurement result of other tests.
cup disposal opening Openings where used
AssayCups are disposed into the solid waste.
cup-on-tube The placement of a smaller secondary sample container (for example a Hitachi standard cup) on top of a primary sample tube.
cycle The instrument time interval during which pipetting or measurement can be carried out.
data alarm Printed or displayed notification that occurs if a result (patient, calibration or QC result) is unexpected or abnormal; an indication of unusual reaction or instrument conditions, for example, insufficient sample or reagent.
data flag See
data manager A PC that coordinates data in real time between the cobas 8000 instrument and the laboratory
LIS. It processes orders from the LIS and manages patient results and QC results.
database A defined section of the computer memory where all instrument, assay, and patient-relevant data are processed and stored.
database management system A software system that provides the necessary procedures and programs to collect, create, organize, store, retrieve, and maintain databases or data files with security and integrity.
dead volume See
minimum sample volume (p. 912).
default profile Predefined test requests that the instrument automatically applies to a sample unless the operator requests different tests.
demographics Patient-related data such as name, date of birth, and gender.
Roche Diagnostics
Operator’s Manual · 4.2.1
909
cobas® 8000 modular analyzer series detection unit - Host communication detection unit A hardware unit comprising a photomultiplier tube, Peltier elements, flow-through measuring cell, magnet drive assembly, and an amplifier circuit board.
deviation of duplicate measurements
Diagnostics The status that is required to perform system diagnostics and hardware error tracking actions.
The field service engineer may request a system to go to
Diagnostics mode to perform such procedures. The system may require initialization afterwards to resume normal operation.
dilute waste solution A waste solution resulting after rinsing with water.
dilution factor A software preset or manually assigned dilution ratio that is used by the instrument to perform a requested dilution.
disk position A dedicated position on the reagent or sample disk.
down time The period of non-operation between an instrument failure and the resumption of operation.
dual value method A mode of expression of the control chart in real-time quality control. For X-axis and
Y-axis, measure simultaneously the average and the standard deviation of control of a low value and a high value, and display them by X and Y coordinates, respectively.
duplicate limit A calibration quality criterion. For a successful calibration, duplicate measurements must be within a specified limit.
dynamic range The reportable range of an assay. This range extends from the lower detection limit to the limit of linearity.
E.Stop A status indicating that the system has performed an emergency stop. This could be due to a hardware failure or because any of the safety devices requested an emergency stop. The system requires either complete power off, or at least initialization, to resume normal operation.
Ecotergent A detergent that can be used as an alternative to Hitergent. It is used as an additive for the incubator bath to reduce the formation of foam. electromotive force (EMF) The physical principle that provides the basis for electrolyte measurement.
emergency stop An instrument alarm level that immediately stops all instrument functions.
endpoint assay An analytical technique taking measurements after a reaction is completed or has been halted. See also
Roche Diagnostics
910 error handling A process during which the instrument attempts to recover from an error condition (for example, an AssayTip is not picked up from the magazine). If the instrument cannot successfully recover from error, an alarm is issued and the instrument is halted.
expected range The predefined range of test result values expected for a defined group of healthy patients or materials. Also known as normal range or reference range.
expected value A value for a test result that can be considered as a normal result. expiration date Also called the expiry date. The end of a period until which Roche Diagnostics guarantees product claims for its reagents, calibrators, and controls. extended dynamic range The measuring range for an assay at its highest dilution.
filter A process that sorts data for viewing, documenting, or printing according to pre-defined criteria first registration The date and time when a reagent or sample was successfully recognized by the barcode reader for the very first time functional sensitivity The concentration of an analyte at which a predefined level of imprecision is obtained.
global button A button that allows access to the global software submenus and that can be used at any time.
gripper A technical device that transports AssayCups and AssayTips to their required destination on the instrument (for example, to the incubator). The gripper moves in three directions (X, Y, and Z).
hard disk (HD) A computer component on which data can be written, stored, and retrieved by the means of magnetization.
Hitergent 1. A detergent, with antibacterial properties, that is added to the incubator bath where it acts as a surfactant, reducing the formation of foam.
2. A surfactant diluted for use in some cleaning procedures.
homogeneous immunoassay (HIA) An analytical technique employing antigens and antibodies. An HIA uses assay protocols similar to clinical chemistry without a bound-free separation (for example, latex assays).
Host communication Data exchange with a clinical laboratory information system (LIS).
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Host computer 1. A computer used for overall management and control of the computer network.
2. A clinical laboratory computer (LIS) that stores and processes patient requests and results. A Host is able to communicate with analytical instruments.
Host interface protocol A technical description that defines data transfer between a Host computer and an analytical system.
ID reader Typically an optical device that reads the identification code of a patient sample or sample rack
(ID) and transfers it to the instrument database.
increased volume rerun A rerun performed after increasing the amount of sample used for the determination.
incubator A temperature-controlled aluminum block for AssayCups on cobas and Elecsys instruments.
incubator bath A temperature-controlled, water-filled reservoir that surrounds the reaction cells. Also called a reaction bath.
initial BlankCell procedure The calibration procedure for ECL instruments performed by Roche
Diagnostics service staff when setting up an ECL-based instrument for the first time.
Initialization The operational mode of an instrument that occurs immediately after power on and during which the instrument prepares itself for operation.
instrument alarm A displayed alarm that indicates an unusual instrument condition such as an abnormal incubator bath temperature or a mechanical malfunction.
Instrument Manager Typically, PC-based software that controls or supervises one or more analytical instruments.
internal reference solution An internal standard solution, assayed between every ISE sample, that compensates for electronic drift.
inventory control The real-time monitoring of the quantities of all consumable items (liquid and solid) on an instrument.
ISE check A maintenance function for checking whether electrolyte analysis can be performed correctly.
ISE prime A procedure that fills the ISE reagent lines and syringes with reagent.
K factor The reciprocal of the slope of the calibration curve. A factor used in conversion of absorbance values to concentration values or activities.
Host computer - manual rerun
Laboratory Information System (LIS) The LIS performs order and result processing. It sends patient orders to the cobas 8000 modular analyzer series and receives related results and, after validation, makes these data available throughout a hospital.
linear barcode A conventional one-dimensional barcode with limited data capacity.
liquid level detection (LLD) The ability of an analytical instrument to sense liquid by using the sample or reagent probes.
liquid waste container A reservoir for liquid waste generated by an instrument; its size and location vary between instruments.
loader See
loading capacity The maximum number of samples that can be loaded into the rack loading area.
local area network (LAN) A computer network covering a limited area, such as an office or a home.
log file A set of data, typically stored in the control unit, that traces instrument-related or operator-related activities such as maintenance.
lot calibration (L-cal) A mandatory calibration when a new lot of reagents is introduced to an analytical instrument.
maintenance item A maintenance procedure performed by the system or the operator.
maintenance key A push button for position movement, used for a probe position check.
maintenance pipe A combination of sequential maintenance items programmed into a fully automated procedure, which can be performed by the instrument without operator intervention.
maintenance procedure A procedure that must be performed on a regular basis (for example daily, weekly, monthly, or every three months) to secure reliable operation of the instrument.
manual dilution An off-system, preanalytical step performed by laboratory staff to reduce the analyte concentration in a sample.
manual rerun A retest function. Although a list of samples required for a rerun is created by following data alarms, rerun is not carried out automatically. After organizing the rerun sample list, the operator directs the rerun.
Roche Diagnostics
Operator’s Manual · 4.2.1
911
cobas® 8000 modular analyzer series masking - order date/time masking A function that temporarily suspends the measurement or calibration of a specific test or measurement with a specific reagent pack. Some masking functions are set by the user (e.g., test masking, patient masking, or reagent pack masking), while others work automatically depending on the condition of the instrument or reagent (e.g., reagent masking or calibration masking). Masking can also be applied to single modules (module masking) so maintenance can be performed on the masked module while the other modules are still processing samples.
master calibration A reference standardization that uses master test kit reagents and certified reference standard material (for example, World Health
Organization reference material) measured at Roche
Diagnostics. The resulting reference standard curve, typically using 10 to 12 points, is the basis for the production of in-house master calibrators.
master curve A lot-specific master calibration curve
(n=5 or 6) measured at Roche Diagnostics using lotspecific test-kit reagents and master calibrators. The shape of the lot-specific master curve is characterized by a four-parameter Rodbard function. The data characterizing this curve is stored in the lot-specific reagent barcode. Lot-specific, calibrator-assigned values
(CalSet-assigned values) are read from the lot-specific master calibration curve and encoded in the CalSet calibrator barcode transfer sheet.
Material Safety Data Sheets (MSDS) Documents that list components of chemical solutions and precautions for the handling and disposal of the solutions.
measuring cell A flow-through device that is used to generate light during the ECL detection process.
measuring channel The entire pathway that is passed by the reaction mixture during the ECL measuring cycle
(including tubing, heat pipe, measuring cell, photo multiplier, and so on).
measuring point Time at which absorbance reading is taken and used to calculate results.
measuring range
See reportable range (p. 915).
Micro cup A secondary sample cup made by Hitachi with a small dead (residual) volume microbead Paramagnetic streptavidin-coated microparticles used as the solid phase for heterogeneous immunoassays in ECL systems.
microbead mixer A paddle or propeller that thoroughly mixes the microbead reagent to ensure resuspension before use.
microparticle See
Roche Diagnostics
912 minimum sample volume The amount of residual sample material plus the volume required for assaying all requested tests to ensure faultless sample aspiration.
minimum signal In ECL assays, a calibration quality criterion. A predefined, assay-specific signal level that must be achieved to establish a valid calibration.
missing value In ECL assays, a calibration quality criterion. All calibrator values must be available for a successful calibration.
mode Defined states of operation of an instrument. See
Instrument statuses (modes) (p. 477)
module An analytical unit that can be combined with others to form larger systems.
monotony of curve A calibration quality criterion. All measured calibrator values must fall in either ascending
(sandwich or bridging principle) or descending
(competition principle) order for a successful calibration.
multi-wavelength spectrophotometer A spectrophotometer in which detectors are placed at multi-wavelength positions to enable simultaneous light reception.
non-barcode mode A mode of instrument operation during which the instrument identifies samples by using the rack and position numbers.
normal range
on-board 1. A technical device or function that is part of the analytical instrument and can be used by the instrument at any time.
2. The availability of reagents and consumables on an analytical instrument for use at any time.
Online Help On-screen documentation that a user can request in a context-sensitive manner and search for any given term.
open request An ordered test that has not yet been performed or completed. Results for a sample may be partially available while some tests are not yet completed.
Operation The operational mode during which the instrument processes samples.
operator ID An alphanumeric ID that a system uses to identify a particular operator. There are several levels including operator, supervisor, and administrator.
order Also called a request. A test selected for a specific sample or control.
order date/time A field used to maintain the arrival date and time of an order in the laboratory. The date/time data may be entered manually or transmitted by LIS protocols.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series order ID The sample order identification refers to a number of sample tubes (one or more specimen types) of a given patient collected for a panel of different tests.
Typically, the sample order identification is printed on order sheets.
P. Mask See
paramagnetic A property of materials that do not exhibit magnetic forces themselves but are capable of becoming magnetic in the presence of a magnetic field.
Magnetic property of microbeads used with ECL technology.
patient ID A set of alphanumeric data that unmistakably identifies a particular patient. For example, a social security number and a sample number.
Patient mask There are two possibilities to mask a test:
Test mask (T. Mask) and Patient mask (P. Mask). If
T. Mask is selected, no patient samples, no controls, and no calibrations can be performed. If P. Mask is selected, the test is masked for patient samples only—calibration and QC can be performed.
pending requests
photometer A device that measures the intensity of light.
photometric assay An assay in which analytes are measured by a photometer.
photometric window A window that enables light to pass from the light source lamp and into the incubator bath.
photomultiplier A light-sensitive tube that collects and amplifies emitted photons from the ECL reaction and converts them into an electric signal.
photon A quantum of electromagnetic energy, having both particle and wave behavior, that carries the light emitted from the ECL reaction.
piercer A punch on the reagent transfer arm that pierces the reagent bottle seals during reagent pack preparation.
pinch valve A valve that pinches the suction tube and switches the flow path.
pipe See
pipetter A device used for pipetting (aspirating and dispensing) a fixed amount of sample or reagent from a sample or reagent container to reaction vessel.
plunger A rod that connects with the drive arm and moves up or down, depending on the pipetting amount.
post-analytical The sample management process, typically storage and archiving, after results have been reported.
Roche Diagnostics
Operator’s Manual · 4.2.1
order ID - protocol potentiometric assay An assay in which analytes (for example Na, K, or Cl) are measured in millivolts by ionselective electrodes.
Power Up The system status while it is loading programs, performing self-checks, and so on. pre-analytical The sample management process before the analytical phase. Preanalytical processing typically involves actions such as sorting and aliquoting.
pre-dilution A dilution step performed before samples are analytically processed on the instrument.
Pre-wash dispenser A technical device that dispenses PreClean into the AssayCups in the Pre-wash station.
Pre-wash sipper Sipper of the PreClean station, which aspirates reaction mixture and PreClean solution from AssayCups.
precision The closeness of agreement between independent test results obtained under prescribed conditions.
PreClean A phosphate buffer used to wash and resuspend the microbeads during the pre-wash step.
preventive action A series of actions, suggested by the system, that the operator should perform before daily operation to ensure sufficient inventory during the day
(for example, the replenishment of reagents and consumables).
primary tube The original tube containing the sample that has been drawn from the patient.
ProbeWash An auxiliary reagent used to wash the reagent probe during special wash steps.
ProCell An auxiliary reagent that transports the reaction mixture from an AssayCup into the measuring cell and aids the ECL detection technology.
processing lane The section of an analytical module where sample racks are moved for pipetting.
profile A user-defined set of test requests.
protocol 1. A convention or standard that controls or enables the connection, communication, and data transfer between two computing end points. Protocols can be implemented by hardware, software, or a combination of the two.
2. A set of rules that guides how an activity should be performed.
913
cobas® 8000 modular analyzer series prozone - reagent probe rinse station prozone The antigen/antibody complex formation is predictable as long as an excess of reagent (antibody) exists. However, in patient samples with very high levels of antigen, the reaction may begin to reverse
(deagglutination) because of the effect of the excess antigen. This is called a prozone effect, and without checking for this phenomenon, abnormally high samples may give incorrect or even false normal results. There are two prozone check methods available: Antigen readdition method and reaction rate method.
QC error An alarm generated when the measured value is outside the defined range. For routine QC, the applied
Westgard Rule is used, for Standby QC, the defined SD range.
qualitative assay An assay that does not allow the determination of the concentration of an analyte, but yields a classification of the sample, such as reactive/nonreactive or positive/negative, with regard to a certain analyte.
quantitative assay An assay that allows the determination of the quantity (concentration or activity) of an analyte.
query download A communication process between instrument PC, data manager, and LIS by which a predefined data set is transmitted from LIS or data manager upon request of the analytical instrument.
rack A sample carrier device that holds sample cups or primary sample tubes (including those for routine samples, standard and washing solutions, quality control,
STAT, and rerun samples). The rack enables easy transportation on analytical systems and modules.
Different rack types can be distinguished by their differing colors.
rack ID A barcode (one-dimensional or binary) at the end of the rack that unmistakably identifies the rack.
rack loading area Area on the top of the core unit where the sample racks to be measured are set. Two rack trays with 15 racks each can be placed into the rack loading area. The total capacity of the loading area is
60 racks (300 samples).
rack pusher arm An arm, located in the rack loading area, that moves racks forward.
rack tray A device for carrying and handling racks. It holds up to 15 racks and is placed directly in the rack loading/unloading area of the instrument.
rack unloading area Area on the top of the core unit that holds the sample racks whose measurements have been completed. The unloading area can store 60 racks
(300 samples) including the two rack trays with 15 racks on each.
Roche Diagnostics
914 random access The ability of an analytical instrument to process requests from a patient sample in any order.
rate assay A determination in which measurements are taken as the reaction proceeds. The rate of the reaction is proportional to the sample component being analyzed. Also known as a kinetic assay.
raw data The unprocessed values obtained during the analytical process on an instrument (for example mV or absorbance).
reaction bath A bath for keeping reaction cells at a defined temperature (37 °C).
reaction cell A plastic cuvette into which sample and reagents are pipetted for the chemical or immunological reactions.
reaction disk A rotatable disk that holds the reusable reaction cells used for photometric measurement.
reagent cap open/close mechanism A mechanism that prevents evaporation by automatically opening and closing the cobas e pack caps before and after reagent pipetting or operation.
reagent compartment A temperature-controlled section on an instrument that holds reagents and diluents.
reagent disk The device in the reagent compartment into which the reagent packs are placed.
reagent mask A function that automatically stops analysis of the current test when a required reagent
( cobas c pack or cobas e pack) is empty or not present on the system. A red bar appears on the test key in the Test
Selection submenu.
reagent pack An integrated reagent carrier consisting of two or three reagent bottles. The term reagent pack is used as an generic term that refers to cobas c packs and cobas e
packs. See also cobas c pack (p. 908)and
reagent pack calibration (R-cal) The calibration performed when a reagent has been on-board the instrument more than 24 hours or when generated by an operator-released calibration. In contrast to a lot calibration, this calibration is valid for one specific reagent pack.
reagent pack number A unique number on the reagent bottle label that identifies each reagent pack.
reagent probe Probe used to transfer reagents from the reagent bottles to the reaction cells.
reagent probe rinse station An area located between the reagent disks and reaction disk where reagent probes are rinsed both internally and externally with water.
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series reagent scan A scan of the reagent disk to read information from the reagent barcode into the instrument and to update the inventory.
real time The display of information on the monitor at the very moment a change to such information occurs.
realtime QC Real-time quality control. A method in which two quality control samples of low and high values are measured, the quantitative values are judged in real time, and an alarm is generated if necessary. recalibration The repetition of a calibration.
reference electrode 1. Electrode through which the reference solution flows to provide a reference potential for ISE measurements (also called reference electrode).
2. A part of the measuring cell used to control the electrochemical process of the ECL reaction.
reference solution A KCl solution aspirated through the ISE reference electrode. Also know as the REF,
ISE REF or reference electrode solution. See
reference electrode (p. 915)(1.).
reflex testing A request for additional testing based on customer-defined algorithms or rules and previous test results.
repeat limit A user-definable limit at which a test is run again under unchanged conditions.
reportable range The range of results that can be reported for the assay. It stretches from the lower detection limit to the high end of the calibration curve.
request See
rerun The performance of the same test on a sample again under the same or changed conditions.
rerun – concentrated The performance of the same test with a less diluted sample, either by decreasing the diluent or by increasing the sample volume.
Reset Operational mode during which the instrument sets and aligns all mechanical parts to their home positions.
Result Date/Time The instrument fills the result date and time after the result calculation is finished. It may be maintained by work area management systems for information purpose.
rinse bath
rinse nozzle A nozzle that supplies or drains detergent or water used for rinsing reaction cells.
rinse station A technical device that cleans probes or disposable tips with deionized water or cleaning solutions to avoid contamination and carryover.
reagent scan - sequence number
Rodbard function A mathematical function used to convert measured signals into concentrations. It uses four parameters to define the shape and position of calibration curves.
S.Stop Abbreviation for sampling stop. A system operating mode in which no new samples are pipetted, but samples already pipetted will be completed without interruption or loss.
S1Abs The absorbance of standard solution 1. The displayed value is 10 000 times greater than the actual measured absorbance.
sample blank The absorbance of the sample plus reagent 1 of a photometric test. The sample blank is subtracted from the actual absorbance reading to obtain the absorbance value relevant for the result calculation.
sample cup A small container that is used for samples and also for calibrator and control material. A sample cup can be placed either on specific racks, other inserts, or on sample tubes. Compared to a sample tube, a sample cup allows the use of smaller liquid volumes and so reduces the dead volume.
sample ID A set of alphanumeric data that unmistakably identifies a particular sample. See also
sample probe Pipetter probe used to transfer sample material from sample containers to reaction cells.
sample rack
sample tray See
sample tube A glass or plastic container for liquid samples to be used with the system. It may or may not have a barcode label, which may be used for positive sample identification. A sample tube contains sample of one specific specimen (sample) type.
sample type One of four types of sample that can be analyzed: serum/plasma, urine, cerebrospinal fluid
(CSF), or supernatant. The sample volume and normal value can be set for each type.
sampling stop An instrument alarm level that indicates a problem with the sampling system. See also
sandwich principle One of three test principles that can be applied to ECL immunoassays. It is used to detect higher molecular weight analytes, such as TSH. See also
competitive principle (p. 909).
secondary tube A sample container of variable size into which aliquots are transferred sequence number A number automatically assigned to each sample by the instrument and used to track samples and orders.
Roche Diagnostics
Operator’s Manual · 4.2.1
915
cobas® 8000 modular analyzer series serum index - tripropylamine (TPA) serum index A function by which the absorbance characteristics of the samples are described to assess the presence of lipemia, hemolysis, and icterus.
serum work area (SWA) The section of a clinical laboratory where all CC, HIA, and HetIA tests (including preanalytical and postanalytical work) are processed.
shutter A door, located on the lid of the reagent disk, that is opened when loading or unloading cobas c packs
( c 702 and c 502 only).
sipper A device to aspirate liquid from a vessel into a flow path, for example, ISE measuring flow path. In ECL systems, a device that aspirates the reaction mixture out of the AssayCup as well as ProCell and CleanCell from their reservoirs into the measuring channel.
slider A device for raising and lowering the aspiration nozzles from the ProCell and CleanCell bottles.
solid waste container A metal waste container holding a liner that collects discarded solid waste.
standard Traceable reference material used to create a
(master) calibration curve. Also referred to as calibrator.
standard deviation A statistic used as a measure of the dispersion or variation in a distribution of data.
standard rack A standardized transportation device for a maximum of five sample containers on Roche
Diagnostics/Hitachi High-Technologies instruments.
Standby An operational mode of the instrument during which power is on but no sample analysis or maintenance procedures are being performed. standby bottle QC The measurement of a quality control sample from a reagent that is on board the instrument but not presently in use for routine testing.
STAT application A special test application (for example, reduced incubation time) for STAT or emergency samples to achieve faster result reporting.
STAT port Special entry area for STAT samples, which will be processed with priority.
STAT sample Emergency sample. Results should be available within shortest possible time.
status LED A status light, for example at the front of the rack loading/unloading area that indicates if a component can be accessed or not.
SysClean An auxiliary reagent used for the periodic cleaning of the measuring cell.
system cleaning solution See
system error 1. A calibration quality criterion that originates from a hardware failure while a calibration measurement is performed.
2. The general term for a case of instrument-related problems.
system reagent See
T. mask See
target range The allowed range of recovery for an analyte in a control material.
target value The mean of all participant responses after removal of outlying values.
technical limit The dynamic range of an assay.
TeleService Net The set of software applications that use cobas link to exchange service information between
Roche service network and a customer's laboratory.
TeleService Net provides remote monitoring and diagnosis, hotline support, and software and documentation updates.
test code The abbreviated name for a test. This code is displayed on test buttons shown on software submenus or windows.
Test mask There are two possibilities to mask a test:
Test mask (T. Mask) and Patient mask (P. Mask). If
T. mask is selected, no patient samples, no controls, and no calibrations can be performed. If P. Mask is selected, the test is masked for patient samples only—calibration and QC can be performed.
test principle A technique that serves as the basis for designing an assay to detect or quantify analytes.
test protocol The sequence of test steps used to perform an assay (for example, volumes and timings). ticket master A part of the instrument software that controls the flow of racks on the instrument.
timeout calibration An instrument mode that automatically generates a calibration request after a predefined interval.
timeout QC A function that measures the quality control sample for the specified item at certain time intervals.
tip
tip eject station An opening in the instrument housing through which AssayCups and AssayTips are discarded.
tripropylamine (TPA) One of two electrochemically active substances used in the ECL reaction.
Roche Diagnostics
916 Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series turn-around-time 1. The time between the decision to perform a test and the time when the doctor receives the result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between receiving a sample and sending out the validated result.
ultrasonic mixer A mechanical unit, in a waterproof pack, that generates ultrasound used to stir samples.
unloader See
upload The process of sending data to Roche by a network link.
validation The process of checking results or data against defined rules or ranges in clinical laboratories.
Validation can be against technical or clinical criteria.
wash solution 1. A solution used to wash reaction cells. The unused solution is stored in a detergent bottle in the instrument.
2. A solution used to wash the reagent probes as specified in the Utility > Special Wash submenu.
waste solution reservoir Container that collects reaction waste.
water level sensor A sensor that monitors the water level of temperature-controlled water.
water supply tank A tank used to store ionexchanged water.
water supply tube A tube for connecting a water supply tank and an instrument.
workarea consolidation The combination of separate workstations to produce one physical or logical workarea in a laboratory. This combination can be achieved through mechanics (a conveyor, for example), facilitated sample transfer (racks or trays), and data management. turn-around-time - workarea consolidation
Roche Diagnostics
Operator’s Manual · 4.2.1
917
workarea consolidation - workarea consolidation cobas® 8000 modular analyzer series
Roche Diagnostics
918 Operator’s Manual · 4.2.1
Index
cobas® 8000 modular analyzer series
Index
Symbols
< >Test (data alarm)
<SigL (data alarm)
>Abs (data alarm)
>Curr (data alarm)
>I.H (data alarm)
>I.HI (data alarm)
>I.I (data alarm)
>I.L (data alarm)
>I.LH (data alarm)
>I.LHI (data alarm)
>I.LI (data alarm)
>Kin (data error)
>Lin (data alarm)
>Proz (data alarm)
>React (data alarm)
>Rept / <Rept (data alarm)
>Sig (calibration alarm)
Roche Diagnostics
Operator’s Manual · 4.2.1
>Test / <Test (data alarm)
A
AB level
Abbreviation
Abnormal Cell List, cell blank measurement, 703
ADC.E (data alarm)
Air purge
– probe replacement, c modules, 754
Air purge, maintenance item, 612
Alarm
– alarm indication (data alarms), 819
– alarm indication (instrument alarms), 820
– button flashes yellow or red, 275
Alcohol (ethanol), warning message, 581
Analysis flow
Analyzer
Application
921
Index
Index
Application setting
– dilution rations, e 602, 552
– qualitative field, c modules, 561
Application submenu
Archive
– saving system parameter, 532
Area
– Module Overview, Overview menu, 242
Aspiration filter
Aspiration of air, pipetter probes, 232
AssayCup
AssayTip
Assigning
– control racks for auto QC, 515
– racks and positions to controls, 469
Asterisk, on maintenance report, 596
Auto masking
– activate calibration masking, 525
Auto QC
– unloading auto QC racks from buffer, 465
auto QC rack
Automatic
Roche Diagnostics
922 cobas® 8000 modular analyzer series
– rerun, application-specific setting, 558
Automatic tube rotation, 83, 84
Auxiliary reagent
Available Tests
B
Backup
Backup operation
– measuring samples in backup operation mode, 499
Barcode
– types of sample barcodes, 98
Barcode label
Barcode read error
– manually assigned rack position, 287
Barcode reader
– for reagent packs, c 502, 172
– for reagent packs, e 602, 192
– positions on system, safety information, 47
Barcode reader window, e 602, 795
Barcoded
Batch mode, sample processing, 298
see Microbead mixer
Biased
– enzyme results, troubleshooting, c modules, 895
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Bubbles
– on sample, safety message, 31
Bubbles in syringe
Buffer rotor, inside Reagent Manager, c 702, 147
Buffering mode
– loading reagents, c 702, 367
Button
C
– cobas c pack, unloading and reloading, 383
– loading auxiliary reagents, 390
– reagent probe rinse station, 170
– reagent probe, location, 170
– sample probe rinse station, 168
– loading auxiliary reagents, 355
Roche Diagnostics
Operator’s Manual · 4.2.1
– reagent probe rinse station, 123
– loading auxiliary reagents, 378
– reagent probe rinse station, 144
– troubleshooting, reagent gripper arm stopped during movement, 896
c modules
– checking calibration results, 441
– maintenance
– Reagent Overview window, 350, 365
– review calibration data, 440
– safety labels, front view, 40
– safety labels, rear view, 44
– troubleshooting, biased enzyme results, 895
923
Index
Index cobas® 8000 modular analyzer series
– troubleshooting, erratic results, 891, 892
– troubleshooting, sample, 893
– troubleshooting, single test, 893
Cal.I (data alarm)
Calc.? (data alarm)
Calculated test
Calculation
– not possible, c modules, 834
– calibrator selection list, 324
– assigning calibrator positions, 426
– cannot be performed, e 602, 899
– checking information about installed calibrators, 429
– checking results (c modules), 441
– edit concentration values, 432
– factor (calibration alarm), 861
– factor, out of limit, e 602, 901
– failure data, c modules, 834
– invalid (data alarm), e 602, 846
– invalid (data alarm), ISE, 824, 834
– manual calibration, 415, 416
Roche Diagnostics
924
– overview over Calibration menu, 419
– quality criteria, e 602, 447
– requesting calibrations, 423
– review results of previous immunological calibrations,
– review results of previous ISE calibrations, 437
– review results of previous photometric calibrations, 443
– review results of the most recent photometric calibration, 442
Calibration (overall system), 415
Calibration and QC Select button, 276
Calibration concept
Calibration error
see Install submenu
(Calibration)
Calibration menu
Calibration method
Calibration status LED, control panel, c 702, 146
Calibrator
– barcoded or non-barcoded, 418
Cancel Maintenance button, 628
Cap
– empty cap waste box, c 702, 376
– open/close mechanism, e 602, 192
– reusing reagent pack caps, c 702, 150, 375
– soft-close position, cobas e pack, 395
Capacity
– data storage on control unit, 210
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
CarOvr (data alarm), e 602, 846
Carryover
– high-priority immunoassays, 311
Cassette
–
Cause
Caution level, instrument alarm, 819
Caution, safety classification, 23
Cell
– perform cell blank measurement, 703
Cell blank
– measure and view results, 703
Cell Blank Measurement
Cell detergent
Cell rinse nozzles
Cell rinse unit
Cell wash
Cell.T (data alarm), e 602, 847
Changeover
Check
– list of maintenance checks, 616
– performing maintenance checks, 594
Check box, software element, 264
Check digit
– types for sample barcodes, 212
Checking
– visual check after start-up, 274
Chemical, general handling notice, 25
Chemistry
photometric test
Roche Diagnostics
Operator’s Manual · 4.2.1
CLAS
– instrument connected to, 485
Class
ClcT.E (data alarm)
CleanCell
Cleaning
–
– incubator bath (c modules), 713
– solutions (e 602), notice message, 584
Clear
Clot.E (data alarm)
cobas c pack
cobas c pack medium, c 502, 381
cobas c pack MULTI
– insufficient filling volume, 30
cobas e pack
cobas link
cobas c pack
Color scheme
– Calibration Status submenu, 422
Index
925
Index
– Test Selection submenu, test matrix, 302
Compensation error
– calculation error, c modules, 835
Compensator, ISE calibrator (S3), 336
Component
Computer
Concentrated waste
Concept
– calibration concept, e 602, 445
– calibration concept, ISE, 435
Condition
– environmental during transport, 209
Conditioning error (calibration alarm), 859
Configuration
Configuring
Consumables
Roche Diagnostics
926 cobas® 8000 modular analyzer series
Container
– for calibrators and controls, 215
– mixing sample containers on a rack, 510
Control
–
– assign racks and positions, 469
Control tower
Control unit
Conventions used, operator’s manual, 12
Cooling fan, clean the cooling fans, 638
Core unit
Cover
– keep covers closed (caution message), 30
– missing (e 602), caution message, 584
– missing (ISE), caution message, 582
– on reagent disk, does not open/close (e 602), 897
– safety information for operation, 229
CSF (cerebrospinal fluid), sample type, 302, 510
– standard cup and micro cup, 214
Cup adapter
– sample tube alignment without cup adapter, 95
Curr.E (data alarm)
Curve
– comparing reaction curve, 883
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Customer
Reaction cell
D
Daily maintenance schedule, all modules, 620
Daily operation
–
Data
– distribution on the system, 58
– patient, display archived data, 322
– preparing DVD for backup, 502
Data distribution, data manager, 74
– checking results on instrument, 289
– sample processing workflow, 297
– editing or deleting sample results, 316
Database
– backup, maintenance check, 618
Date
Decontamination, instrument, 52
Degasser, draining the tank, 640
Roche Diagnostics
Operator’s Manual · 4.2.1
Deleting
Detergent
Development channel
Deviation
– module to module variance, e 602, 903
Device
Diff.E (calibration alarm)
Diluent
Diluted sample
Dilution
Direct mode
– loading reagents, c 702, 367
Disinfectant
– for cleaning instrument surfaces, 641, 687, 756
Dispenser
Disposal
– of control unit components, 52
Document
927
Index
Index
Duplicate limit
– Dup.E calibration alarm, c modules, 860
– Dup.E calibration alarm, e 602, 861
DVD
– applicable types for backup, 502
E
– calibration factor out of limit, 901
– ECL unit, specifications, 223
– loading auxiliary reagents, 404
– magazine waste compartment, 203
– maintenance
– microbead mixer rinse station, 192
– Pre-wash area, rinse station, 191
– reaction system, specifications, 222
– reagent probe rinse station, 193
– reagent system, specifications, 223
Roche Diagnostics
928 cobas® 8000 modular analyzer series
– safety information for operation, 233
– safety labels, front view, 42
– sampling system, specifications, 222
– troubleshooting calibration, 899
– waste handling, specifications, 223
e 602 module maintenance
E.Stop, status explanation, 477
Ecotergent
– for incubator bath, c 502, 174
– for incubator bath, c 701, 125
– for incubator bath, c 702, 152
– incubation water exchange rate, 521
Ecotergent/Hitergent setting, 521
Edited (data alarm)
Editing
Electrical supply
Electrical supply, power not available, 881
Electrode
– clean ISE electrodes (green rack), 648
– replace ISE REF electrode, 674
Emptying, concentrated waste container, 655
Environment
– conditions during transport, 209
Enzyme, results biased, c modules, 895
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Erratic result
– ISE module, troubleshooting, 885
– troubleshooting, c modules, 891
Erratic results
– troubleshooting, c modules, 892
Error
Essential Information Upload, maintenance check, 618
Evaporation, safety message, 31
Expiration date
Expired
– reagent, incorrect result, 335
Extended power OFF, e 602, 801
Extended power off/on pipe, 604
F
– areas in the help window, 250
F1+F2 button
Fatigue, long hours of operation, 33
Favorite
– using favorites in Help window, 255
Features
Fill height, sample containers, 215
Film
– on sample, safety message, 31
Filter
– radiator filter, c modules, 727
– solenoid valve, c 701/c 702, 732
Finalization
Foam
– incorrect level, c 701/c 702, 368
– inside reagent pack, c 701/c 702, 352
Formula
– Utility Application submenu, 563
Front view
– safety labels, c modules, 40
Function
– key, list of keys (instrument software), 266
G
Green status lamp
Green wash rack
Green wash rack, c modules, 693
Green wash rack, ISE module, 646
Gripper
– arm stopped during movement, troubleshooting
– consumables area, e 602, 199
– move to home position (c 702), 896
Roche Diagnostics
Operator’s Manual · 4.2.1
929
Index
Index
H
HbA1c
– notes for the use of the application, 547
Help
– areas in the help window, 250
– buttons in the help window, 250
Hemoglobin A1c application, 544
High result
High-priority immunoassay, potential carryover, 311
History window
Hitergent
– for incubator bath, c 502, 174
– for incubator bath, c 701, 125
– for incubator bath, c 702, 152
– incubation water exchange rate, 521
Hitergent/Ecotergent setting, 521
Holidays, programming time switch, 491
data manager
I
ID
Immunoassay
Inc.T (data alarm)
Incubation water exchange rate, 521
Incubator
Roche Diagnostics
930 cobas® 8000 modular analyzer series
– temperature, data alarm, e 602, 850
– water exchange rate for Hitergent/Ecotergent, 521
Infection
– by waste solution, Protective equipment, 28
– waste solution and solid waste, e 602, 796
Information
Initialize, status explanation, 477
Insoluble contaminants in samples, 31
Installation, safety information, 24
Installing
– special wash parameters, 572
Instructions for Use, on cobas link, 75
Instrument
– general troubleshooting, 880
Instrument alarm, Alarm window, 275
status
Insufficient reagent
– Reag.S alarm, c 701/c 702, 842
Interaction
– advanced software interactions, 257
– basic software interactions, 257
Interlock
Internal standard
Introduction
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Inventory update
– green buttons, e 602, 412, 798
– calibration, requesting, 343
– calibrators and controls, 337
– checking calibration results, 436
– replace pinch valve tubing, 672
– review calibration data, 436
– safety information for operation, 231
– safety labels, rear view, 44
ISE module maintenance
IStd.E (calibration alarm), 861
IVD
IVD directive
Roche Diagnostics
Operator’s Manual · 4.2.1
K
Key
– maintenance button, c 502, 181
L
Label, safety label description, 35
LED
–
Liquid level detection
– Sample LLD data alarms, e 602, 855
Liquid level sensor assembly, inside water tank, 636
LIS
– connection with cobas 8000, 57
– sample processing workflow, 297
List
List box
Load List
Loading
– auxiliary reagents, ISE, 344
– port, Reagent Manager, c 702, 367
Loading limit, c 702, 360, 530
Logoff
Lot
931
Index
Index
Low level
Low result
Low value
LSS, liquid short sensor (PreClean bottle), 202
M
Magazine
– waste compartment, e 602, 203
Main menu
Maintenance
– periodic replacement of parts, 629
– possibilities during a shift, 292
Maintenance (e 602 module)
Maintenance (ISE module)
Roche Diagnostics
932 cobas® 8000 modular analyzer series
Maintenance actions (c 702 only)
– checking reagent gripper, 711
– cleaning discharge chute for reagent caps, 709
– cleaning reagent gripper, 758
– cleaning waste box for reagent caps, 756
Maintenance actions (c 701/c 702)
– cleaning filter of solenoid valve, 732
Maintenance actions (c 702 only)
– cleaning reagent pack gripper, 758
Maintenance actions (c modules)
– draining the vacuum tank, 745
– replacing photometer lamp, 733
Maintenance actions (core unit)
Maintenance actions (e 602 module)
– cleaning instrument surfaces, 812
– cleaning microbead mixer, 777
– cleaning rinse stations, 779
– replacing PC/CC reservoirs, 768
– replacing pinch valve tubing, 784
Maintenance actions (ISE module)
– washing reagent flow path, 670
Maintenance button, c 502, 181
Maintenance checks
Maintenance interval
Maintenance items
Maintenance pipe
– recommended maintenance pipes, 603
– weekly pipe, all modules, 604
Maintenance pipe function, 595
Maintenance report
Maintenance schedule
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Maintenance type
Maintenance videos, list of, 630
Manual
Marking, test selection matrix, Test Selection submenu,
Masking
– auto masking (calibration), 482
– overview about different functions, 478
– tests or patient samples, 478
Measurement
– request QC measurement, manual, 463
Measuring channel, assign tests, e 602, 576
Mechanical safety, caution message, 30
Mechanism Check, maintenance check, 616
Menu
– Calibration Calibrators, 426
– Workplace Calib. Review, 323
Roche Diagnostics
Operator’s Manual · 4.2.1
– Workplace Test Selection, 301
Menu summary
Microbead mixer
Mixer
– consumables area, e 602, 199
Mixing volume
MIXLOW (data alarm)
Mode
– rerun, non-barcode mode, 308
Module
– trouble on each channel in module, 872
– performing background maintenance, 626
Module power off, status for maintenance, 590
Module sample buffer
Monitor
Mono.E (calibration alarm)
Monotony
Index
933
Index
Moving part
MPA
– barcode mode with non-barcoded samples, 297
– instrument connected to, 485
N
na.LHI (data alarm)
NaCl
Non-barcoded
Non-standard tube
Notice, safety classification, 23
Nozzle
– cell rinse unit, unclog, 741
Nozzle tips, replace, c modules, 743
O
OBS.RR (data alarm)
On-board stability
– OBS.RM (data alarm), c 702, 840
– OBS.RR (data alarm), c modules, 841
– OBS.RR (data alarm), e 602, 851
Online Help
Operation
– daily operation, workflow, 241
– interrupt, move c 702 gripper, 148
– interrupt, terminate Rack Reception Mode, 289
Roche Diagnostics
934 cobas® 8000 modular analyzer series
Operator
– troubleshooting responsibility, 877
Operator time, maintenance, 589
Operator’s Manual
Operator-controlled (manual) maintenance, 589
Option
Order processing workflow, 298
Out of order
– instrument unused for an extended period of time, 25
Over.E (data alarm)
Overdue, maintenance intervals, 606
Overview
– reagent level alarm settings, 528
– Reagent Overview window, c 502, 386
– Reagent Overview window, e 602, 401
– Reagent Overview window, ISE, 339
Overwrite, download application, 541
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
P
Parameter
– description of Analyze parameters, 551
– description of application parameter, 551
– description of Calib. parameters, 552
– description of Formula parameters, 563
– description of Other parameters, 562
– description of Range parameters, 556
– installing special wash parameter, 572
Parameter Download
Parameter Download button, 276
Parameter group
Partial Overwrite, download application, 541
Performing
Period check box, maintenance type, 607
Personal protective equipment, 24
Photometer
– specification, c modules, 221
Photometric modules
Photometric test
Piercer
Pinch valve
Maintenance pipe
Pipetter
Power
Roche Diagnostics
Operator’s Manual · 4.2.1
Power off
– note for longtime power off, 33
– single modules for maintenance, 591
Power Up
Powering off
Powering on
PreClean
– temperature out of range, 856
Prep.E (calibration alarm), ISE, 863
Preparation, status explanation, 477
Pretreatment
Preventive Action
– before routine operation, 284
Pre-wash area
Printing
Priority
– change priority of sample rack, 318
– high-priority immunoassay, #-flag, 311
– racks loaded from STAT port, 287
Probe
– check horizontal alignment, 752
– clean probes, c modules, 693
– clean sample probes, ISE, 651
– replace probes, c 701/c 702, 747
Index
935
Index
– wash reagent probe, immune module, 570
– wash reagent probe, photometric modules, 565
Probe check, maintenance check, 616
ProbeWash
ProCell
Processing
Profiles, assigning tests or profiles to test key, 517
Programming
– clear timer programming, 491
– special wash, chemistry modules, 565
– special wash, immunological module, 570
Protective equipment
– infection by samples and materials, 27
Push button
Q
QC
–
– assigning control positions, 469
– configuring automatic QC, 526, 558
– performing calibration and QC, 280
Roche Diagnostics
936 cobas® 8000 modular analyzer series
QC menu
QC sample
– barcoded or non-barcoded, 456
QC Violation, automatic calibration, 416
Qualification, of operator, 24
Quality criteria, calibration, e 602, 447
Question mark, Setting submenu, 334
R
– correct alignment of sample tubes, 95
– transfer mechanism, caution message, 230
– unloading QC racks from the auto QC buffer, 465
– unloading sample rack during analysis, 317
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Range
see Cell
Reaction disk
Reaction system
– specifications, c modules, 219
Reag.F (data alarm)
Reag.H (data alarm)
Reag.S (data alarm)
Reag.T (data alarm)
– all modules, introduction, 329
– reagent types, abbreviations in software, 331
– registration, module overview, 329, 330
– setting initial loading limit, c 702, 530
– setting yellow loading limit, c 702, 530
– storage compartment, c 502, 169
– storage compartment, c 701, 122
– volume, incorrect result, 30
Reagent area
Roche Diagnostics
Operator’s Manual · 4.2.1
Reagent cap
– cleaning discharge chute, c702, 709
– cleaning waste box, c 702, 756
Reagent cap open/close mechanism, e 602, 192
Reagent compartment
Reagent disk
– cover does not open/close, e 602, 897
– temperature abnormal, e 602, 852
Reagent level
Reagent Load/Unload List
Reagent Manager
– to control racks on the buffer rotor, 370
Reagent Overview window
Reagent pack
– cap soft-close position, e 602, 395
– multiple with same reagent, c 701/c 702, 352, 368, 387
– remaining volume control, c 502, 383
– remaining volume control, c 701, 347
– remaining volume control, c 702, 362
– remaining volume control, e 602, 396
– transfer mechanism, c 702, 145, 148
Reagent pack gripper
Reagent Preparing
Reagent prime
– before finalization, e 602, 799
Reagent probe
937
Index
Index
– does not descend to liquid surface, 883
– special wash, immune module, 570
– special wash, photometric module, 565
Reagent registration check box, maintenance pipe, 598
Reagent registration, c 701, 347
Reagent registration, c 702, 362
Reagent syringe
– bubbles in (ISE module), 887
Reagents (overall system), 329
ReagEx (data alarm)
Real-time query mode, sample processing, 298
Rear view
Recovery of control values, e 602, 902
Recycling, of the instrument, 52
Reference electrode
Registration
– auxiliary reagents, c 502, 385
– auxiliary reagents, c 701, 349
– auxiliary reagents, c 702, 364
– c modules, module overview, 329
– ISE and e modules, module overview, 330
Reloading
Remaining
– column in the Setting submenu, 334
Remaining volume control
– auxiliary reagents, c 701, 349
– auxiliary reagents, c 702, 364
– auxiliary reagents, ISE, 338
Roche Diagnostics
938 cobas® 8000 modular analyzer series
Repeat limit
Repeat limit (data alarm)
Replacement, periodic replacement of parts, 629
Replacing
– ISE reference electrode, 674
– PreClean, troubleshooting, 898
– ProCell/CleanCell, troubleshooting, 897
– sample probe detergents, c 502, 391
– sample probe detergents, c 701, 357
– sample probe detergents, c 702, 379
Report
Requesting
Rerun
– automatic (data alarms), 819
– automatic, application-specific setting, 558
– manual, non-barcode mode, 308
Restoring, system parameter, 534
Result data
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Results
– editing or deleting sample results, 316
– erratic, ISE module, 884, 885
Reviewing
RFID label
RFID reader
Rinse station
Routine operation
Rsp1.E (calibration alarm)
Rsp2.E (calibration alarm)
Rules
S
S.Stop
S1A.E (calibration alarm)
Safety information
– for operation, c modules, 232
– general safety information, 21
Roche Diagnostics
Operator’s Manual · 4.2.1
Safety label
– positions on the instrument, side view, 43
Samp.? (data alarm)
Samp.B (data alarm)
Samp.C (data alarm)
Samp.O (data alarm)
Samp.S (data alarm)
Sample
– clot (data alarm), e 602, 853
– container, specifications, 213
– contamination, foreign material, 230
– correct alignment of tubes on a rack, 95
– mismatch, non-barcode mode, 230, 297, 309
– mixing sample types on a rack, 510
– tracking on the analyzer, 290
– tube alignment with cup adapter, 95
– volume, decreased/increased, 873
Sample clogging (data alarm)
Sample Data Clear
sample probe
Sample probe
939
Index
Index
– replacing detergents, c 502, 391
– replacing detergents, c 701, 357
– replacing detergents, c 702, 379
Sample syringe
– bubbles in (ISE module), 888
Sample Tracking button
Sample type
– explanation of list box, 302, 510
– mixing sample types on a rack, 510
Sample volume
– incorrect definition, micro cups, 230
Sampling area
Sampling system, specifications, c modules, 220
Screen
– cannot access another screen, 882
SD.E (calibration alarm)
Search
Searching
Selecting
Sens.E (calibration alarm)
Serum index application
Serum index check (data alarms)
Setting
Sig.E (calibration alarm)
Roche Diagnostics
940 cobas® 8000 modular analyzer series
Signal
– maximum (calibration alarm), e 602, 865
– minimum (calibration alarm), e 602, 865
Sipper
– probe for measuring channels, e 602, 195
Skin inflammation, by reagent or other solution, 28
Skin inflammation, by reagent residue, 150, 371, 376
SLLD.E (data alarm)
SLLD.N (data alarm)
Slop.E (calibration alarm)
Soft-close position, cobas e pack, 395
Software
– areas in user interface, 238
– component, cobas e-service, 60
– components of the analyzer, 57
– design and functionality, 257
– elements, list box, 259, 262
– elements, menu and submenu, 258
– elements, parameter group, 259
Software-controlled maintenance, 589
Solid waste
– clean compartment, e 602, 796
Solution
–
Special reagent
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
Special wash
– reaction system, c 502 module, 383
– environmental condition, 209
– reaction system, c modules, 219
– sampling system, c modules, 220
Spilled liquid
Standard high, ISE calibrator, 336
Standard low, ISE calibrator, 336
Standard tube
Standby
Start
– start analysis, safety information, 34
Start-up
STAT
– process rack with priority, 318
– requesting test manually, 305
Status
– for background and parallel maintenance, 624
– lamp at magazine drawer (e 602), 410
Roche Diagnostics
Operator’s Manual · 4.2.1
– lamp at waste container (e 602), 410
– LED at loading port, c 702, 368
– LEDs at unloading tray, c 702, 372
– maintenance schedule, c modules, 691
– maintenance schedule, e 602, 763
– maintenance schedule, ISE module, 645
Status submenu (Calibration), 422
– requesting calibrations, 423
Std.E (calibration alarm)
Stop
Stop and S.Stop, instrument alarms, 819
Storage
Submenu
Supernatant, sample type, 302, 510
Support, calling technical support, 878
Surfaces
Symbol
Syringe
– bubbles in (ISE module), 887
Sys.E (calibration alarm)
SysClean
– liquid flow path cleaning, e 602, 782
SysR.S (data alarm)
SysR.T (data alarm)
System
Index
941
Index
– reagent pack management, c 502, 171
Overview menu
T
Technical limit
Technical support, calling, 878
Test
– calibrating tests during operation, 421
– checking calibrations of immunological tests, 449
– checking calibrations of ISE tests, 436
– inactivate control tests, 473
– multiple photometric tests, 894
– selecting tests for standby bottle QC, 464
– selecting tests for start-up calibration, 425
Test Selection submenu
Text box, software element, 264
Throughput
Time
Time switch
Roche Diagnostics
942 cobas® 8000 modular analyzer series
– set for automatic start-up, 488
– set present time and day, 489
Time To Unload
– reagent manager settings, 524
Timeout
Top view
– safety labels, c modules, 37
Touchscreen
Trouble
– attributed to characteristics of reagent, 871
– on each analytical module, 872
– on each channel in same module, 872
– general instrument troubleshooting, 880
– operator’s responsibility, 877
Tube rotation
Type
– barcode types for samples, 98
Operator’s Manual · 4.2.1
cobas® 8000 modular analyzer series
U
Ultrasonic mixer
Unloading
– rack reset, maintenance item, 611
– reagent packs from buffer rotor, c 702, 376
– sample rack during analysis, 317
Unloading tray, reagent pack, c 702, 148
Unreadable sample barcodes, 307
Upload, essential information, maintenance check, 618
Urgent Information, maintenance check, 618
User interface
–
Software
see Application submenu
Utility Maintenance submenu see
Maintenance submenu
Utility System Configuration submenu
see System
Configuration submenu
V
Vacant Slot
– reagent manager settings, 524
Vacuum
Vacuum tank, draining, c modules, 745
Validating
Validation, calibration (automatic checks), 417
Value
– edit concentration value, 432
Version
Roche Diagnostics
Operator’s Manual · 4.2.1
Version 05-01, new features, 16
Video, list of maintenance videos, 630
Viewing
Volume, minimum sample volume, 213
Vortex mixing station
W
Warning, safety classification, 23
Wash rack
Washing
Waste
– emptying solid waste, e 602, 412
– ISE waste solution (label), 43
– solid waste container, e 602, 203
Waste container, ISE module, 113
Waste outlet
Water inlet filter
Water tank
Water trap, draining the tank, 640
WB.S (data alarm)
WB.T (data alarm)
WEEE, disposal of components, 52
Index
943
Index
Whole blood HbA1c application, 544
Window
Work Flow Guide
Workflow
Workplace
– overview over Workplace menu, 300
Workplace menu
Y
cobas® 8000 modular analyzer series
Roche Diagnostics
944 Operator’s Manual · 4.2.1
Revisions
advertisement
Key Features
- Automated Photometric Analysis
- High Throughput
- Random Access
- In Vitro Diagnostics
- cobas 8000 System Integration
- Wide Test Menu
- Clinical Chemistry
- Immunochemistry
