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cobas
®
8000 modular analyzer series
Operator’s Manual
Software Version 02-01
cobas ® 8000 modular analyzer series
Document information
Manual version
1.0
2.0
Software version Revision date Changes
01-01 June 2009
02-01 January 602 module added
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.
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
Intended use agreement null and void.
Software updates may only be carried out by Roche service representatives.
The cobas
®
8000 modular analyzer series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitiative in-vitro determinations using a wide variety of tests.
The cobas
® equipment.
8000 modular analyzer series is an in-vitro diagnostic (IVD) medical
It is important that the user reads the Operator’s Manual thoroughly before using the cobas
®
8000 modular analyzer series.
Copyright
2009-2010, 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.
Roche Diagnostics
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cobas ® 8000 modular analyzer series
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 European Standard EN591.
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
Notice to the purchaser of cobas e 602 module(s)
The cobas
®
Issued by Intertek for Canada and the US.
8000 instrument complies with the emission and immunity requirements described in standard IEC 61326-2-6: 2005.
The purchase of this product allows the purchaser to use it solely for detection by
ECL Technology for human in vitro diagnostic uses. No general patent or other license of any kind other than this specific right of use from purchase is granted hereby. This product may not be used by purchaser to conduct life science research and/or development, patient self-testing, drug discovery and/or development or in any veterinary, food, water or environmental testing or use.
US Pat. 5,466,416; US Pat. 5,543,112; US Pat. 5,624,637; US Pat. 5,632,956; US Pat.
5,720,922; US Pat. 5,061,445; US Pat. 5,068,088; US Pat. 5,247,243; US Pat. 5,147,806;
US Pat. 5,779,976; US Pat. 6,325,973; US Pat. 5,296,191 and corresponding patents in other countries.
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Operator’s Manual · Version 2.0
3
Contact addresses
Manufacturer of cobas
®
8000 instrument
Manufacturer of cobas
®
8000 data manager
Authorized representative cobas ® 8000 modular analyzer series
Hitachi High-Technologies Corporation
1-24-14 Nishi-Shinbashi
Minato-ku, Tokyo 105-8717, Japan
Roche Diagnostics Ltd.
Forrenstrasse
CH-6343 Rotkreuz, Switzerland
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim, Germany
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cobas ® 8000 modular analyzer series
Table of contents
Online help system of the instrument
Online Help system of the data manager
Conventions used in this document
Part
ISE module
701 module
502 module
602 module
A–154
A–155
A–157
A–159
Safety information for barcode readers
3 Core components of the system
A–53
Sample containers, racks and trays A–64
Roche Diagnostics
Operator’s Manual · Version 2.0
Part
9 Safety information for operation
The help system of the instrument
Software design and functionality
cobas ISE module)
cobas c 701 module)
cobas c 502 module)
cobas e 602 module)
B–101
B–110
B–123
B–136
ISE module)
B–173
701 and c 502 modules) B–177
602 module) B–183
5
cobas ® 8000 modular analyzer series
Installing the HbA1c application
Archiving data and performing data backups B–231
Part
Introduction to the cobas® 8000 data manager C–5
8000 data manager and associated workflows C–5
®
8000 data manager C–7
8000 data manager interface C–10
Validating test results manually
Working with tests and reference ranges
Configuring test measurement units
8000 data manager
C–117
Archiving data to external media
Browsing data using the TraceDocViewer
27 Safety information for maintenance
Part
Combined maintenance schedules
Background and parallel maintenance
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29 Maintenance of the core unit
Maintenance schedule for the core unit
30 Maintenance (cobas ISE module)
cobas ISE module
31 Maintenance (cobas c 701 and c 502 modules)
cobas c 701 and c 502 modules
D–117
D–69
32 Maintenance (cobas e 602 module)
cobas e 602 module
D–191
ISE module)
701 and c 502 modules)
602 module)
Part
Part
Part
E–73
E–78
E–85
Part
cobas ISE module) E–10
cobas c 701 and c 502 modules) E–19
cobas e 602 module)
E–31
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Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series
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Preface
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. It is optimized for high throughput workloads using a combination of an ion selective electrode ( cobas ISE module), photometric analysis
( cobas c 701 and c 502 modules), and immunoassay analysis ( cobas e 602 module).
The cobas® 8000 data manager implements data and workflow management functionality and acts as an interface with the cobas® 8000 instrument, the laboratory information system (LIS), and the Roche Teleservice Network. It can manage and consolidate up to three fully equipped cobas® 8000 instruments. Through the Roche
Teleservice Network 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.
The cobas® 8000 modular analyzer series cobas® 8000 data manager cobas® 8000 instrument
Figure 1-1 The cobas® 8000 modular analyzer series
The Operator’s Manual contains a detailed description of the cobas® 8000 modular analyzer series. It describes operating instructions and maintenance procedures as well as troubleshooting procedures.
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.
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Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series
Where to find information
The following documents are provided to assist in finding desired information quickly:
Operator’s Manual Contains information about safety, hardware modules and operating the analyzer, as well as maintenance and troubleshooting. A table of contents at the beginning of the book and each chapter, and an index at the end of this manual help you to find information quickly. A glossary offers detailed explanations for selected key words.
Online Help Contains a detailed description of the software of the cobas® 8000 modular analyzer series. In addition to the software description, the entire Operator’s Manual is available in the Online Help. This makes it possible to retrieve information from both
Online Help and the Operator’s Manual using the search functions available for electronically stored documents.
e See:
Online help system of the instrument on page 11
Online Help system of the data manager on page 11
COBI CD The COBI CD (Compendium of Background Information) provides you with background information about the technologies, test principles, their theory and
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
calibration methods used by the cobas® 8000 instrument.
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.
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cobas ® 8000 modular analyzer series
Online help system of the instrument
F1 Help
Direct Help
The user interface 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 instrument software offers two help features: o F1 Help and o
Direct 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.
e For more information on F1 Help, see:
Searching for information in the help system on page B-28.
Direct Help 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.
e For more information on Direct Help, see:
About Direct Help on page B-32.
Online Help system of the data manager
The data manager application provides online help for every window and dialog box.
The online help appears in a dedicated window.
You display online help in context by pressing [F1].
Selecting DM help on the Help menu opens the online help at its table of contents.
Additionally, the online help provides an index, and search and bookmarking functionality.
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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
Tip a Start of procedure
End of procedure o e
List item
Cross-reference
Cross-reference for information provided in the Online Help of the instrument.
Roche Diagnostics
12
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.
Abbreviations The following abbreviations are used:
Abbreviation Definition
Numbers c 502 module (used in the user interface only) e 602 module c 701 module
5
6
7
A
ANSI
ASCII
C c 701 c 502 c7-1, c7-2, c7-3
Cal.
CC
C.E.
Cfas
CLAS 2
CLIA clinchem
CLSI
COBI CD
CSA
American National Standards Institute
American Standard Code for Information Interchange cobas c 701 module for photometric assays cobas c 502 module for photometric assays
First, second, third c 701 module of the instrument
Calibration
CleanCell, an auxiliary reagent used on the e 602 module
Carryover Evasion
Calibrator For Automated Systems
Clinical Laboratory Automation System 2
Clinical Laboratory Improvement Amendments
Clinical chemistry
Clinical & Laboratory Standards Institute
Compendium Of Background Information
Canadian Standards Association
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Roche Diagnostics
Operator’s Manual · Version 2.0
Abbreviation
CSF
CV
D
DAT dB(A)
L
LDL
LIS
LLD
M
MSB
I
ICVC
IB1, IB2, … i.e.
IEC
IS
ISE
IVD
IVDD
K
KCL kVA
GUI
H
HbA1c
HCFA
HIS
I
HPI
DIL
DM
E e 602 e6-1, e6-2, e6-3
EC
ECL e.g.
EMC
EMF
EN
G
Definition
CerebroSpinal Fluid
Coefficient of Variation (%)
Drugs of Abuse Testing
Decibel weighted against the A-frequency response curve. This curve approximates the audible range of the human ear.
Diluent
Data Manager cobas e 602 module for immunoassay analysis
First, second, third e 602 module of the instrument
European Community electrochemiluminescence exempli gratia – for example
ElectroMagnetic Compatibility
ElectroMotive Force
European standard
Graphical User Interface
Hemoglobin A1c, glycosylated hemoglobin
Health Care Financing Administration
Hospital information system
High-Priority Immunoassay
ISE module (used in the user interface only)
Initial Cassette Volume Check
Module sample buffer (Instrument Buffer) id est – that is to say
International Electrical Commission
Internal Standard (for ISE module)
Ion Selective Electrode; also used for ISE module
In Vitro Diagnostic
In Vitro Diagnostic Directive potassium chloride, reference solution for ISE module kilovolt-Ampere. Unit for expressing rating of AC electrical machinery
Lower Detection Limit see analytical sensitivity
Laboratory Information System
Liquid Level Detection
Module Sample Buffer
13
Roche Diagnostics
14 cobas ® 8000 modular analyzer series
SVGA
T
TDM
TPA
U
UL
W
WAM
Abbreviation
MSDS
N n/a
NCCLS
P
P
PC
PC/CC
PSM
Q
QC
R
RCM
Reac.
REF
RFID
R.P.
S
SD
SIP
STAT
Std
SU
Definition
Material Safety Data Sheet not applicable
National Committee for Clinical Laboratory Standards
Photometric module
Personal Computer (the control unit)
ProCell / CleanCell, auxiliary reagents used on the e 602 module
Process System Manager (software)
Quality Control
Reaction Calculation Module
Reaction bath temperature (used on the Overview menu)
Reference solution for ISE module
Radio Frequency Identification
Reagent Pack
Standard Deviation
ISE sipper syringe
Short Turn-Around Time
Standard, commonly used for calibrator rack Sampler Unit, the rack loader/unloader
(SU is used on the Overview menu)
Super Video Graphics Adapter
Therapeutic Drug Monitoring tripropylamine
Underwriters Laboratories Inc.
Work Area Manager (a middleware software)
Operator’s Manual · Version 2.0
System description
A
1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
2 Overview system components . . . . . . . . . . . . . . . . . . . . . . . . . . A-31
3 Core components of the system . . . . . . . . . . . . . . . . . . . . . . . . . A-49
4 cobas ISE module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-73
5 cobas c 701 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-87
6 cobas c 502 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-105
7 cobas e 602 module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-125
8 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-143
cobas ® 8000 modular analyzer series
General safety information
1 General safety information
Table of contents
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 · Version 2.0
In this chapter Chapter
1
Reagents and other working solutions .......................................................... A-11
A-3
1 General safety information
Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
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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:
The safety alert symbol by itself (without a signal word) is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document.
These symbols and signal words are used for specific hazards:
WARNING
Indicates a hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
NOTICE
Indicates a hazardous situation which, if not avoided, may result in property damage.
e For more information about the product safety labels, see
Safety labels of the system on page A-16.
Important information which is not safety relevant is indicated by the following symbol:
Tip
Indicates additional information on correct use of the system or useful tips.
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cobas ® 8000 modular analyzer series 1 General safety information
Safety precautions
Safety precautions
Particular attention must be paid to the following safety precautions. If these safety precautions are ignored, the operator 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.
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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 on page A-143). 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 circuit breaker switch must be set to OFF. Remove and refrigerate any remaining reagents. For further information, call technical support.
Relocation and transportation Do not attempt to relocate or transport the instrument. Leave relocation and transportation to personnel trained or authorized by Roche.
e For information about disposal of the instrument, see:
Disposal of the instrument on page A-29
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Operator’s Manual · Version 2.0
A-7
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
Part
and Part
The following figure shows the available modules of the cobas 8000 instrument:
F A B C D C E
A Core unit
B ISE module
Figure A-1
C Module sample buffer
D c 701 module e
E c 502 module
F e 602 module
Modules of the cobas 8000 instrument (the control unit is not shown in this figure)
For more information about the system components, see:
Warning messages
C
List of warning messages
Before operating the instrument, read the warning messages contained in this summary carefully. Failure to observe them may result in death or serious injury.
WARNING
Electrical safety
Electrical shock from electronic equipment
Removing covers marked with this symbol can cause electric shock, as there are high voltage parts inside. In addition, opening the top cover of the c 701 or c 502 module and touching the ultrasonic mixing mechanism during operation can also cause electric shock.
o Do not attempt to work in any electronic compartment. o Do not remove any cover of the instrument other than those specified in the Operator’s
Manual. o Do not open the top cover of an c 701 or c 502 module and touch the ultrasonic mixing unit during operation or when the instrument performs maintenance.
o Installation, service, and repair must only be performed by personnel authorized and qualified by Roche. o
Observe the system safety labels illustrated on pages A-18 to A-26 and in particular the
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cobas ® 8000 modular analyzer series 1 General safety information
Safety summary
Biohazardous materials
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.
o Follow standard laboratory practices, especially when working with biohazardous material.
o Keep all covers closed and in place while the instrument is operating. o 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.
o 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.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o 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.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
the following: T-1, T-8, T-9, T-14, T-15, F-2, F-7, R-1, R-2.
Infection and injury due to sharp objects
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.
Reagents and other working solutions
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.
o When handling reagents, exercise the precautions required for handling laboratory reagents. Be sure to wear protective equipment (such as goggles, gloves). o Observe the cautions given in the package insert and observe the information given in the Material Safety Data Sheets available for Roche reagents and cleaning solutions. o 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.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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Operator’s Manual · Version 2.0
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1 General safety information
Safety summary
Waste
WARNING cobas ® 8000 modular analyzer series
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. o 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. o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
o
Observe the system safety labels illustrated on pages A-18 to A-26 and in particular the
following: F-8, F-9, F-15, S-2, R-6, R-8.
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.
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 regulations.
o
Dilute waste: A non-concentrated waste solution diluted with rinsing water from cell wash or water from the incubation 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. Therefore liquid waste and replacement parts such as reaction cells and ISE electrodes have to be treated as infectious medical waste.
o When disposing of any waste generated by the instrument, do so according to the relevant laws and local regulations.
e For information about disposal of the instrument, see
Disposal of the instrument on page A-29
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A-10 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 1 General safety information
Safety summary
Caution messages
CAUTION
List of caution messages
Before operating the instrument, read the caution messages contained in this summary carefully. Failure to observe them may result in minor or moderate injury.
Mechanical safety
Personal injury due to contact with moving parts o Keep all covers closed and in place while the instrument is operating. o 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.
o Only trained personnel should have access to the keys to the protective covers of the instrument.
o Do not touch any parts of the instrument other than those specified. Keep away from moving parts during instrument operation.
o Do not remove the covers of the rack conveyor lines.
o Only load or unload racks when the green status LEDs on the rack loader are on.
o During operation and maintenance of the instrument, proceed according to the instructions.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
the following: T-1, T-7, T-12, F-2, F-4, F-6, F-13, R-1, R-2.
Reagents and other working solutions
Incorrect results due to incorrect reagent volume
Application faults may cause an undetectable loss of reagent.
o Store reagents always according to specified storage conditions.
o Do not reuse a reagent pack whose reagent has been spilled.
o Do not use a single reagent pack for different instruments.
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 package insert. 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. o Ensure that the cobas c pack MULTI contains the correct filling volume. Refer to the package insert.
Insoluble contaminants in samples
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. o When loading samples on the instrument, make sure that samples contain no insoluble contaminants such as fibrin or dust.
o Ensure to prepare enough sample volume for measurement.
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Safety summary cobas ® 8000 modular analyzer series
Foam, bubbles or films on sample
CAUTION
Incorrect results due to incorrect sample volume
Foam, bubbles or films on a sample or inside a sample container may cause pipetting volume shortage and lead to deterioration in measurement accuracy.
o When loading samples, calibrators and controls on the instrument, make sure that they do not contain foam, bubbles or films.
Evaporation of samples or reagents
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.
o Do not expose samples, calibrators, or quality controls that have been pipetted into a sample container to open air for any length of time.
o 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.
o Do not use expired reagents. Do not leave reagents on the instrument for a prolonged period of time.
Cross contamination of samples
Incorrect results due to carryover
Traces of analytes or reagents may be carried over from one test to the next.
Take adequate measures to safeguard additional testing and to avoid potentially false results.
e For more information about avoiding carryover and cross-contamination between tests,
see Special Wash submenu on page B-270.
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1 General safety information
Safety summary cobas ® 8000 modular analyzer series
Data security
CAUTION
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.
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
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.
The electromagnetic environment should be evaluated prior to operation of the device.
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 RF sources).
Do not operate the following devices in the same room where the instrument is installed: o Mobile phone o Transceiver o Cordless phone o Other electrical devices that generate electromagnetic fields
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Safety summary cobas ® 8000 modular analyzer series
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. o Take a break for 10 to 15 minutes every hour to relax. o Avoid spending more than 6 hours per day looking at the monitor screen.
Spillage
Malfunction due to spilled liquid
Any liquid spilled on the instrument may result in malfunction, or damage of the instrument. o Do not place samples, reagents or any other liquid on the surface of the instrument.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
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A-14 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 1 General safety information
Safety summary
Notices
NOTICE
Moving parts
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.
o Keep all covers closed and in place while the instrument is operating.
o Do not touch any parts of the instrument other than those specified. Keep away from moving parts during instrument operation.
o Only load or unload racks when the green status LEDs on the rack loader are on.
Powering-on and starting analysis
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.
o Make sure no maintenance item or check is being performed when powering on the instrument or starting analysis.
Cleaning solvents
List of notices
Before operating the instrument, read the notices contained in this summary carefully.
Failure to observe them may result in damage to equipment.
Damage to the instrument due to the use of organic solvents for cleaning
Organic solvents may dissolve surfaces of the instrument.
o Do not use any organic solvents except for isopropyl alcohol or ethanol.
Circuit breakers and fuses
Damage to the instrument due to improper use
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.
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Safety labels of the system
Safety labels of the system
cobas ® 8000 modular analyzer series
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.
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.
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A-16 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
2 kg Max.
1 General safety information
Safety labels of the system
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.
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.
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Safety labels of the system
Top view – ISE and photometric modules
T-1 T-2 cobas ® 8000 modular analyzer series
T-2 T-3 T-4
Figure A-2
T-6 T-10
T-11 T-1 T-9
Top view of the instrument (ISE, c 701 and c 502 modules)
T-4 T-8 T-7
2 kg Max.
T-5
Warning: Possibility of infection or injury due to contact with operating mechanisms!
Keep covers closed whenever possible.
T-1
Spilled liquids, e.g. water or detergents, may cause instrument damage.
Wipe up spilled liquids immediately.
T-2
T-3
T-4
Caution against pinch by mechanism!
Do not touch any moving parts.
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.
Attention to maximum load of the cassette table
Do not place anything other than reagent packs upon the table.
T-5
2 kg Max.
Observe direction when loading reagent packs at the c 502 module!
T-6
T-7 Warning: Possibility of injury due to contact with mechanisms!
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T-8
T-9
T-10
T-11
1 General safety information
Safety labels of the system
Warning: Possibility of infection due to contact with mechanisms!
Follow standard laboratory practices for working with biohazardous materials.
Warning: Possibility of electrical shock inside the instrument
Do not remove this cover.
Observe direction when loading racks at the module sample buffer!
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.
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Safety labels of the system
Top view – cobas e 602 module
T-12 cobas ® 8000 modular analyzer series
T-13 T-14 T-15
Roche Diagnostics
A-20
T-14
T-15
T-16
T-17
Figure A-3
T-2
T-12
T-13
T-17 T-16
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.
Warning: Possibility of infection due to contact with mechanical parts
Follow standard laboratory practices for working with biohazardous materials.
Caution: Measurement accuracy may be reduced if the reagent disk cover is opened!
Keep the reagent disk cover closed during analysis.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Front view – ISE and photometric modules
F-1 F-2 F-2
1 General safety information
Safety labels of the system
F-1 F-3 F-4
Figure A-4
F-10
F-2
F-5 F-6 F-8 F-7 F-6 F-9 F-6
F-1
F-6
Front view of the instrument (ISE, c 701 and c 502 modules)
F-8
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.
F-5
Caution against contact with piercer
Do not touch any moving parts.
F-3
F-4
F-5
F-6
F-7
Caution against contact with the loading mechanism for reagent packs!
Do not touch any moving parts.
Caution: Detergent and/or reagent may cause skin irritation!
Observe safety precautions. Wear protective equipment.
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 sipper syringe!
Follow standard laboratory practices for working with biohazardous materials.
Warning: Possibility of infection due to contact with waste from the vacuum tank!
F-8
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Safety labels of the system cobas ® 8000 modular analyzer series
F-9
F-10
Front view – cobas e 602 module
F-11 F-5 F-13 F-14
F-12
Warning: Possibility of infection due to contact with ISE drain ports!
Caution: Touching the ISE drain ports during analysis may lower measurement precision!
Keep the front doors closed during operation.
F-5
Figure A-5
F-16 F-5 F-6
Front view of the e 602 module
F-11
F-5
F-6
F-11
F-12
F-13
Roche Diagnostics
A-22
F-15
Caution: Detergent and/or reagent may cause skin irritation!
Observe safety precautions. Wear protective equipment.
Warning: Fingers or skin may be pinched by syringe (when plunger is moving).
Do not touch any moving parts.
Caution: Incorrect results due to misplaced reagents
Observe correct positions when replacing reagents. Only replace a bottle if the green push button is flashing.
Attention to the status of the green illuminated push buttons!
Replace the bottle only when the green light is flashing.
Warning: Possibility of infection and injury due to contact with mechanical parts
Keep the top cover closed whenever possible.
Operator’s Manual · Version 2.0
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F-14
F-15
F-16
1 General safety information
Safety labels of the system
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.
Warning: Possibility of infection due to contact with used
AssayTips and AssayCups!
Follow standard laboratory practices for working with biohazardous materials.
Caution against injury due to contact with PreClean needles!
Do not put your hands into the PreClean bottle holder.
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Safety labels of the system
Side view – complete instrument
cobas ® 8000 modular analyzer series
S-1
S-3
Figure A-6
S-1
S-2
S-3
S-2
Left view of the instrument
Observe rack direction when loading racks at the STAT port!
Warning: Possibility of infection due to contact with ISE waste solution from the waste solution tank!
Follow standard laboratory practices for working with biohazardous materials.
Caution: Water may leak from water tanks
Before disconnecting the joint, close the tap at the water tank.
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A-24 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Rear view – ISE and photometric modules
R-1 R-2 R-3 R-1
1 General safety information
Safety labels of the system
R-1 R-4
Figure A-7
R-8 R-7 R-5
Rear view of the instrument
R-1
R-2
R-3
R-6
R-7
R-4
R-5
R-8
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Operator’s Manual · Version 2.0
R-8 R-7 R-5 R-6 R-5
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 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: 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 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.
Caution: Incorrect results due to loose tube connectors
Follow all instructions for water inlet filter maintenance carefully!
Warning: Possibility of infection due to contact with waste solution!
Follow standard laboratory practices for working with biohazardous materials.
A-25
1 General safety information
Safety labels of the system
Rear view – cobas e 602 module
R-1 cobas ® 8000 modular analyzer series
Roche Diagnostics
A-26
Figure A-8
R-1
R-5
R-7
R-8
R-8
Rear view of the instrument
R-7 R-5
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 electrical shock
Do not remove these covers!
Caution: Incorrect results due to loose tube connectors
Follow all instructions for water inlet filter maintenance carefully!
Warning: Possibility of infection due to contact with waste solution!
Follow standard laboratory practices for working with biohazardous materials.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 1 General safety information
Safety information for barcode readers
Safety information for barcode readers
WARNING
BC-2
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.
o Do not stare into the beam of a laser or LED barcode reader.
o 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.
o The use of controls or adjustments or the performance of procedures other than those specified herein may result in hazardous radiation exposure.
The following two figures show the position of the barcode readers and the directions of their apertures in the cobas® 8000 instrument:
BC-1 BC-3 BC-4 BC-5
Figure A-9 Localization of barcode readers – Core unit, ISE module and c 701 module
No.
Table A-1
Module
BC-1 Core
Wavelength Pulse width and pulse frequency
112
μ s
Output power Max. output of laser diode
660 nm 1.0 mW
8.93 kHz
Laser barcode reader in the cobas® 8000 instrument
10 mW
Remark
Class 2 laser
IEC 60825-1, +A2:2001
The cobas® 8000 core unit is a class 1 laser product. 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.
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Safety information for barcode readers
BC-6 BC-7 BC-8 cobas ® 8000 modular analyzer series
BC-9 BC-10 BC-11
Figure A-10 Localization of barcode readers – c 502 and e 602 module
No.
Module
BC-2 Core
BC-3 ISE
BC-4 c 701 MSB
BC-5 c 701
BC-6 c 502 MSB
BC-7 c 502
BC-8 c 502
BC-9 e 602 MSB
BC-10 e 602
BC-11 e 602
Table A-2
Wavelength
655 nm
655 nm
655 nm
655 nm
655 nm
655 nm
655 nm
655 nm
Output power Remark
10
μ
W
10
μ
W
10
μ
W
10
μ
W
10
μ
W
10
μ
W
10
μ
W
10
μ
W
102.92
μ
W
10
μ
W
LED barcode readers (class 1)
655 nm
655 nm
LED barcode readers in the cobas® 8000 instrument
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A-28 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 1 General safety information
Disposal of the instrument
Disposal of the instrument
WARNING
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.
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).
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.
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.
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Disposal of the instrument cobas ® 8000 modular analyzer series
Roche Diagnostics
A-30 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Overview system components
2 Overview system components
Table of contents
This chapter provides an overview of all system components of the cobas® 8000 modular analyzer series .
In this chapter Chapter
2
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Table of contents cobas ® 8000 modular analyzer series
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A-32 Operator’s Manual · Version 2.0
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 A-11 The cobas®
B cobas 8000 instrument
8000 modular analyzer series cobas 8000 instrument The cobas 8000 instrument consists of: o cobas 8000 control unit - software o cobas 8000 instrument - hardware (core components and instrument modules)
Figure A-12
A
A cobas 8000 control unit PC
The cobas® 8000 instrument
B
B cobas 8000 instrument modules and core components
A cobas 8000 instrument is a set of minimum one and maximum four individual instrument modules, a core unit, and an ISE module.
e For more information about the instrument hardware, see:
Hardware components on page A-39.
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2 Overview system components
Overview cobas ® 8000 modular analyzer series cobas 8000 basic structure Given below, a schematic overview will present 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 too, or, depending on the laboratory workflow needs, somewhere else.
Data Manager
Software
Control Unit
Software
M1 cobas 8000 instrument modules
M2
Hardware
M3 M4
Figure A-13 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 loader and unloader for up to 300 samples o Has an independent sample buffer for each module with random access o
Has environmental controlled compartments to extend on-board lifetime of reagents and controls 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 samples/hour o
Is controlled by a data manager that allow 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 the c 701/ c 502 modules o Performs electrochemiluminescence assays on the e 602 module
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A-34 Operator’s Manual · Version 2.0
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 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 user friendly 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.
Figure A-14 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
It processes patient demographics, orders, results o It offers independent QC data management including graphical presentation o
It can be adapted to local requirements of QC standards and rules o It allows centralized result flag tracking of all instrument modules o
It provides online e-services o More efficient implementation of new requirements and software upgrades
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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:
HIS LIS DM Instrument Modules
A
Figure A-15
B C
A HIS - Hospital Information System
B LIS - Laboratory Information System
The cobas 8000 modular analyzer series - as part of the laboratory communication
D
C DM - data manager
D Instrument - is a set of modules
Outside of the cobas 8000 modular analyzer series, the HIS and LIS are available.
Component tasks These are the main tasks of the component presented above: o The HIS is the central data base system which traces patient data and make it 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: e-services
LIS
Results
•
QC
Results
•
Sample
Orders
DM
Results
•
CAL
Results
•
QC
Results • Sample
Orders
Instrument Modules
Figure A-16 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.
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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 A-17 Control unit PC - example installation and software GUI
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2 Overview system components
Software components
Software of cobas link
cobas ® 8000 modular analyzer series
The cobas link is an integrated system consisting of a PC ( cobas link data station) and a 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.
e For more information about cobas link ,
The user interface for working with cobas link is the cobas e-library. There is a separate Operator’s Manual for the cobas e-library available. e For more information on working with the e-library, refer to the cobas e-library
Operator’s Manual.
Figure A-18 Screen cobas e-library
This screen is also reachable on the data manager via the screen sharing function at the side bar.
e
.
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A-38 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 2 Overview system components
Hardware components
Hardware components
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 502 modules for clinical chemistry analyses o e 602 module for immunoassay analyses
A
A Core unit
B ISE module
Figure A-19
B C D C E C
C Module sample buffer
D c 701 module
Example of a cobas 8000 configuration. The control unit is not presented in this figure.
corresponding units:
E c 502 module
F e 602 module
The cobas 8000 instrument consists of the following products and their
F o
Core unit (model: cobas 8000 Core)
O Rack sampler unit
O
Rack conveyor o ISE module (model: cobas 8000 ISE) o cobas c 701 module (model: cobas 8000 c 701)
O c 701 analyzer unit
O c 701 module sample buffer o cobas c 502 module (model: cobas 8000 c 502)
O c 502 analyzer unit
O c 502 module sample buffer o cobas e 602 module (model: cobas 8000 e 602)
O e 602 analyzer unit
O e 602 module sample buffer
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cobas ® 8000 modular analyzer series 2 Overview system components
Hardware components
A list presenting some of the main features is given below:
Core unit ISE c 701 c 502 e 602 o Up to 200 racks/h
(1000 samples/h) o Loading area: 4 trays with
15 racks each (max. 300 samples) o Unloading area: 4 trays with
15 racks each (max. 300 samples) o Up to 900 test/h and ISE module o Up to 2000 photometric tests/h o 70 positions for cobas c packs large o Up to 600 photometric tests/h o 60 positions for cobas c packs medium o Automatic reagent pack loading / unloading o Up to 170 tests/h o 25 positions for cobas e packs o Rerun buffer: Located directly beside each module: Up to
20 racks
Applications: o 3 electrolyte applications o 200 photometric applications o 200 photometric applications o 100 applications preprogrammable o 8 calculated tests o 3 serum indices o 8 calculated tests o 3 serum indices o ECL
(a)
technology for heterogeneous immunoassays
Table A-3
(a) Electrochemiluminescence
Basic specifications of the cobas 8000 components
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Core unit
2 Overview system components
Hardware components
Main tasks of the core unit are: o Manage loading and reloading 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.
From this unit, racks are transported to individual instrument modules via a transportation line and, after being processed, returned via a return line .
A
B
C
D
A Rack loader/unloader area
B STAT input port
Figure A-20
C
D
Core unit as seen from the front
Status LED’s
Instrument power ON / OFF
Presented in figure
A-21 is a view of the top layout of the core unit.
Loading and unloading racks is possible during routine operation when the green Status LEDs are on.
In order to prevent any misplacement of racks, only a one way direction placement of racks is possible.
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2 Overview system components
Hardware components
Dummy position text
C
B cobas ® 8000 modular analyzer series
D
E
A
Place racks in this direction only
A Rack unloading section
B Rack Buffer area
D Return line
Schematic top view of the loading / unloading area of the core unit
C STAT port
Figure A-21
E Transportation line
F Rack loading section
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
F
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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.
A
B
ISE module
A ISE unit 2
Figure A-22
B ISE unit 1
The ISE module contains two individual ISE units; each unit is able to process up to
900 tests per hour (300 samples per hour).
The following are the main components of an ISE module: o ISE measuring compartment with measuring cartridges for Cl
-
, K
+
, Na
+
and
Reference cartridge o ISE pipetter for both ISE units o Individual ISE reagent compartments for each ISE unit
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2 Overview system components
Hardware components
Module sample buffer
cobas ® 8000 modular analyzer series
The module sample buffer is able to buffer racks in order to allow an optimized rack management. Additionally, a temperature-controlled compartment extends onboard stability of QC control material.
A
A Backup operation port for manual rack supply
Figure A-23 Module sample buffer
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.
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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 A-24 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 2 sampling probes working simultaneously o 4 reagent probes working simultaneously o 1 cuvette ring with 406 reaction cells (cuvettes) o 2 refrigerated reagent compartments
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.
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2 Overview system components
Hardware components
cobas c 502 module
cobas ® 8000 modular analyzer series
The c 502 module is a high performance photometric module for clinical chemistry analyses.
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A Module sample buffer c 502 module Figure A-25
A B
B 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.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
cobas e 602 module
2 Overview system components
Hardware components
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.
Figure A-26
The following are the main components of the e 602 module: o Reagent area e 602 module o Measuring area o Consumables area o Pre-wash area
Reagent area The reagent area comprises the left side of the instrument 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 instrument 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.
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2 Overview system components
Hardware components cobas ® 8000 modular analyzer series
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Core components of the system
3 Core components of the system
Table of contents
This chapter provides a brief description of components that are part of every system.
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Operator’s Manual · Version 2.0
In this chapter Chapter
3
Sample tube alignment without cup adapters .............................................. A-67
Sample tube alignment with cup adapters .................................................... A-67
A-49
3 Core components of the system
Table of contents cobas ® 8000 modular analyzer series
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Overview
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.
Data manager
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.
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Figure A-27 The data manager PC - example of installation and software GUI
A-51
3 Core components of the system
Data manager cobas ® 8000 modular analyzer series
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:
Orders
Sample
Results
Sample
Results
QC
Orders • Sample
Results
•
Sample
Results
•
QC
Results • CAL
Orders
•
Sample
Orders • QC
Orders
•
CAL
Results
•
Sample
Results
•
QC
Results • CAL
LIS Data Manager CU
Instrument
Modules
Data alarms • Results
Instrument alarms
Data alarms
•
Results
Instrument alarms
Figure A-28 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. Furthermore, the data manager is able to keep
QC results , patient results and data alarms (flags).
e
For details on the data manager, please refer to the corresponding Part C Operation data manager .
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cobas ® 8000 modular analyzer series 3 Core components of the system cobas link
cobas link
The cobas link platform is the gateway for retrieving and distributing information – such as instructions for use, value sheets, important notes, and test- and lot-specific instrument settings – from Roche TeleService infrastructure to cobas instruments in the laboratory.
The cobas link is an integral and mandatory part of the cobas® 8000 modular analyzer series. The cobas link communicates directly with the data manager. No operator intervention is necessary.
TeleService infrastructure 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.
TeleService infrastructure cobas link
Internet data manager cobas instruments
Figure A-29 cobas e -services cobas link functions These functions are available by cobas link: o e-barcodes (e-BC): Test specific instrument settings. Values of calibrators and controls.
o e-package inserts (e-PI): Instructions for use. Value sheets of calibrators and controls. Important notices (e.g., re-assigned control values).
o e-reference documents: Current product information o screen sharing: Function to support the instrument and the customer.
e Since these services are made available via the GUI of the data manager, please refer to
for details.
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3 Core components of the system
Control unit
Control unit
cobas ® 8000 modular analyzer series
NOTICE Damage to the instrument due to magnetic fields
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 A-30 Control unit PC - example of installation and software GUI
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Control unit
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.
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.
Keyboard
Selecting Items To select a successive range of items in a list, press <Shift> 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 <Ctrl>, then touch the desired items.
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, so called shortcut keys, these functions can be executed too.
e
For more information, see Shortcut keys on page B-43
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.
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3 Core components of the system
Core unit
Core unit
cobas ® 8000 modular analyzer series
The core unit is a core component. Core components are always part 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
F
D
Figure A-31
G
E
H
Core unit front view
A Rack loader/unloader section
B STAT input port
C Status LED’s
D System Power ON
E Software load status (Service only)
F System Power OFF
G Timer ON / OFF
H Timer (hidden behind flap)
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C
A Power outlet control unit and data manager
B Power inlet
Figure A-32 Core unit rear view
A
C Power circuit breaker
B
Operator’s Manual · Version 2.0
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 be 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 of the environmental controlled chambers inside of the module sample buffers.
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Operator’s Manual · Version 2.0
A
A Core unit
Figure A-33
B
B Module sample buffer
Core unit and one module sample buffer
In a full size system there will be up to 4 module sample buffers - fully controlled by the core unit.
A-57
3 Core components of the system
Core unit cobas ® 8000 modular analyzer series
Rack loading / unloading
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.
o In accordance with a GLP keep the cover closed during routine laboratory procedures.
This protects samples in this section from being contaminated. 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 that the tray handle direction is as presented at Figure A-
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 .
Tray placement
Racks are loaded into the system by placing them onto trays.
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Figure A-34 Loading trays
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Rack capacities
3 Core components of the system
Core unit
The right lanes are in charge of loading racks with a total capacity of 4
×
15 racks –
2
×
15 in buffer area and 2
×
15 in input area.
The left lanes are in charge of unloading racks with a total capacity of 4
×
15 racks.
Racks in output area undergo final processing in this system and can be removed from the unloader for further laboratory processing or archiving.
B C
Status LED ON
Access OK
Status LED OFF
No access
Figure A-35
A
A Status LED
B Unloading racks
Rack sample section as seen from the top - four empty trays are loaded.
C Loading racks
The status LED indicates if a lane can be accessed or not.
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3 Core components of the system
Core unit
STAT rack loading
cobas ® 8000 modular analyzer series
Any rack loaded via the STAT port is processed with a higher priority compared to those racks already available on the system.
Loading a STAT at this port will ensure the highest processing priority .
Barcode label position. Before loading a STAT rack, ensure that the barcode label(s) are in the correct position. This is very important in order to prevent any barcode read error.
Using red racks for STAT samples is mandatory!
e For information on the different types of racks, see
Rack classes and colors on page A-69.
Barcode reader
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 following tasks: o
Scan rack barcode of each sample rack o Scan barcodes of each sample within a rack
Barcode reading failed If an individual barcode is not readable, an error message indicates this situation.
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cobas ® 8000 modular analyzer series 3 Core components of the system
Core unit
Power switches
Main power ON/OFF
Power circuit breaker in position ON
There are two types of power switches: o A main power push-button switch 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.
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 switch
All power circuit breakers
Related components and function
Core unit. Powering ON/OFF the whole instrument except the cooling systems
Individual module. Powering ON/OFF the affected module including its cooling system
Table A-4 Power switches
A B
A Module sample buffer - c 502 module
B Module sample buffer - c 701 module
Figure A-36
C ISE module
D 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 switch is used. This allows continuous operation of all cooling systems and therefore fast powering
ON/OFF.
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3 Core components of the system
Module sample buffer (MSB)
Module sample buffer (MSB)
cobas ® 8000 modular analyzer series
The module sample buffer is a so-called core component, as this unit is always part of a cobas® 8000 system.
Module sample buffer functions
The main functions of the module sample buffer are: o Buffering racks as part of the rack management o
Environment temperature controlled chamber for extended shelf live of the
QC material o A backup port to insert single racks if a backup operation is necessary.
e
For details on how to use this port, see Backup Operation on page B-226.
A Module sample buffer
Figure A-37 Module sample buffer
A B
B Backup operation port for manual rack supply
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cobas ® 8000 modular analyzer series 3 Core components of the system
Module sample buffer (MSB)
A B C D
A Water buffer bottle
B Water inlet
Figure A-38
C
D
Module sample buffer rear view
Power circuit breaker
Power inlet
Physically, the module sample buffer is directly aligned with an instrument. Logically, it is fully controlled by the core unit.
corresponding module.
The module sample buffer does not provide any waste drain; this is provided by the
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3 Core components of the system
Sample containers, racks and trays
Sample containers, racks and trays
cobas ® 8000 modular analyzer series
This chapter describes the different sample containers and components used to transport samples.
Figure A-39 A tray loaded with racks
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.
Tubes and cups are inserted in sample racks.
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. The graphic below gives an overview about terms that are used throughout this manual.
A
B
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A Rack ID
Figure A-40 Sample and rack terms
B Rack color
Rack ID Rack ID is allocated to sample types , like: o Serum, Plasma, Urine, CSF, etc.
Rack color Rack color is allocated to sample classes , like: o Routine, STAT, Rerun, Calibrator, and Control samples
Operator’s Manual · Version 2.0
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Sample containers
3 Core components of the system
Sample containers, racks and trays
The material to be analyzed is supplied to the instrument in sample containers.
Sample containers are available in different shapes: tubes or cups .
Sample tubes
Standard and micro cups
CAUTION
CAUTION
A
A Sample tube
B Micro cup
Figure A-41
B C D
C Standard cup
D False bottom tube
A subset of sample container variations
Sample tubes are the primary collection tubes used for larger material volumes.
Example sizes are: o Diameter 13 mm / Length 75 mm o
Diameter 16 mm / Length 100 mm
Standard cups and micro cups are used for small amounts of sample material. Both can be inserted directly onto a rack.
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.
e For sample container specifications, see
Sample containers on page A-152.
Incorrect results or damage to the instrument due to wrong cup size
Hitachi 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.
o Use the cup size as registered for each sample.
Incorrect results due to the use of micro cups on e 602 modules o When the tip of the sample probe touches the inner wall of a micro cup this may result in improper sample aspiration.
o Do not use micro cups on e 602 modules.
o Do not use micro cups for calibrators and controls.
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Sample containers, racks and trays cobas ® 8000 modular analyzer series
Non-standard tubes
Sample tubes with the following dimensions can also be used: o Length between 63 mm - 102 mm o Outer diameter between 11 mm - 16 mm o Inner diameter > 10 mm ( > 9.7 mm for HbA1c whole blood samples)
Non-standard tubes and false bottom tubes can be used for patient samples and controls.
Please contact Roche technical support for more information about the use of non-standard tubes and other sample containers.
False bottom tubes
False bottom tubes are used for small amounts of sample material.
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Sample containers, racks and trays
Correct alignment of sample tubes on a rack
Take special care with regard to the alignment of sample tubes when placed onto a 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 or reagent probe may attempt to sample outside the tube, causing errors and incorrect results.
Sample tube alignment without cup adapters
The following figure illustrates correct and incorrect alignment of a sample tube on the rack.
The tube position must be straight vertically . This is important in order to ensure the maximum barcode readability for every tube, thus reducing the rate of barcode error problems.
Sample tube alignment
Correct - position perfect aligned
Incorrect - position misaligned
Figure A-42
Sample tube alignment with cup adapters
To improve the alignment of 13 mm tubes on the rack, Roche recommends that
Roche cup adapters are used. Cup adapters are inserted into standard racks as shown in the following figure.
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3 Core components of the system
Sample containers, racks and trays
A B C cobas ® 8000 modular analyzer series
Sample classes
A Roche cup adapter
B Insert adapter into rack
Figure A-43
C
Placing a cup adapter into a rack
13 mm tube placed in a rack position with cup adapter
The Roche cup adapters should be used only for sample tubes specified for use with the cobas 8000 instrument.
Tubes with an outer diameter greater than 13 mm should not be used in combination with cup adapters, because the barcode label might be damaged.
Tubes for the e 602 with an outer diameter less than 13 mm must be used in combination with cup adapters.
The instrument is able to process different sample classes. These are: o
Patient samples
O Routine samples
O
STAT samples
O Rerun samples o
Calibrators o Controls.
Every sample rack can carry up to five sample containers.
Sample types
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Patient samples are available with different sample types .
To process different sample types, it is necessary to allocate individual number ranges for racks. For further information, please refer to section Rack number ranges .
e For more information about rack number ranges, see:
Rack classes and colors on page A-69.
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Racks
3 Core components of the system
Sample containers, racks and trays
A standard rack design is used as a transport carrier for all types of containers throughout the cobas® 8000 system. This chapter explains all rack details.
Rack classes and colors
Racks are available in different colors which are allocated to individual sample classes. This simplifies the handling of sample classes.
The standard sample rack is gray .
The table below provides an overview of rack classes:
Rack class
Routine rack
Rack color
Gray
Display in software Label ID on rack
001-3999
STAT rack Red
50001-50999
60001-60999
70001-70999
80001-80999
S40001- S40999 S001-S999
Calibrator rack Black
White
C20001- C20999 C001-C999
QC rack Q30001-Q30999 Q001-Q999
Wash rack Green
Rerun rack Pink
Rerun racks are used for manual reruns in non-barcode mode only!
Table A-5 Rack types
W999 W999
R001-R999 R001-R999
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3 Core components of the system
Sample containers, racks and trays
Rack ID cobas ® 8000 modular analyzer series
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
Rack number ranges
B
A Rack ID - operator readable
B Rack ID - system readable
Figure A-44 Rack ID
On the analyzer different sample types are available, such as: o Serum/Plasma o
Urine o CSF o
Supernatant o Whole blood o
Oral fluid o Other
To process these different sample types, a rack number range must be defined for each sample type.
As an example, some number ranges are presented below: o Serum - rack number range 001 - 100 o
Urine - rack number range 401 - 500 e
To assign a rack number range to a sample type, see Rack Assignment on page B-238.
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Barcodes
Barcodes
All samples that are loaded onto the instrument, are identified by barcodes. This chapter provides information about the sample barcodes.
Sample identification
The sample barcode label provides the unique sample identification.
e
For label dimensions and placement specifications, see Barcode types on page A-150.
Barcode types
CAUTION
The following barcode types can be used for samples on the cobas® 8000 system: o
Code 39 o Code 128 o
ITF o NW-7
Incorrect results due to barcode reading errors
Barcode reading errors could potentially go undetected when a check digit is not used.
o Use only barcodes with check digits. o Use only barcode labels of a good printout quality.
o When using ITF, do not use mixed-up ID digit numbers.
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3 Core components of the system
Barcodes cobas ® 8000 modular analyzer series
Readability of barcodes
To minimize barcode read errors it is necessary to align barcode labels correctly.
Position in line
Position out of line
Figure A-45 Barcode label positions in and out of line
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 e read error will be issued.
For information on sample barcodes, see:
Roche Diagnostics
A-72 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
cobas ISE module
4 cobas ISE module
Table of contents
This chapter provides a detailed description of the ISE module, ISE components,
ISE functions and technical specifications.
In this chapter Chapter
4
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Operator’s Manual · Version 2.0
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Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
A-74 Operator’s Manual · Version 2.0
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 measurement units. The throughput of the ISE module can be up to 1800 tests per hour (if equipped with two measurement units).
Figure A-46 ISE module
Components of the ISE module The ISE module can be subdivided into the following components: o
Sampling area e
For more information, see Sampling area on page A-77
o
Measuring area e
For more information, see Measuring area on page A-78
o
Reagent system e
o
Components behind the front doors e
See Front view – behind the door on page A-82
o
Components at the rear side of the module e
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Top view
Top view
cobas ® 8000 modular analyzer series
Presented below is the ISE module as seen from the top.
A
B C
A ISE sample probe
B ISE measuring unit 2
Figure A-47
C ISE measuring unit 1
ISE components as seen from the top
ISE sample probe The ISE sample probe transports small sample volumes from a sample tube, located in a sample rack, to the dilution vessel.
e
For more information, see Sampling area on page A-77
ISE measuring units 1/ 2 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 sensitive electrodes, in order to determine a concentration of individual ions.
e
For more information, see Measuring area on page A-78
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A-76 Operator’s Manual · Version 2.0
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Sampling area
Given below is a description of components and positions:
4 cobas ISE module
Top view
A
B
C
D
E
F
A Sampling position
B Rinse station
C Sample Cleaner 1
Figure A-48 ISE measurement sequence
D Sample Cleaner 2
E Measuring position of ISE unit 2
F Measuring position of ISE unit 1
Sampling position When the sample tube is located beneath position A , 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 indicated.
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 indicated.
e For more information about the ISE cleaning solution, see
Auxiliary reagents (ISE module) on page B-103.
Measuring position ISE 1 and 2 The ISE pipetter dispenses the patient sample here into a vessel which is located beneath this position.
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Top view
Measuring area
cobas ® 8000 modular analyzer series
The ISE measuring compartment is fully isolated and temperature controlled.
Presented below are the main components
A B
A Vessel, sippers and nozzles
B Ion sensitive electrodes
Figure A-49
C
C Pinch valve
D
D 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 Figure A-
A B C D E F
J K J 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 A-50 ISE schematic diagram
H G
G Drain for ISE and reference electrodes
H Supply for diluent
I Supply for internal standard
J Ultrasonic mixer
K Vessel
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.
Cl
-
, K
+
, Na
+
electrodes Special electrode design. By using membranes with an open liquid junction it is able to measure ion-selective.
REF electrode This electrode uses the same design of the ion-electrodes. It is exclusively used as a reference for every measurement.
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Top view
Control 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
F
A Dilution vessel
E
C Cup - used for maintenance only
D
B Sipper nozzle to supply the ISE electrodes
Figure A-51 The vessel and related parts
D Nozzle for diluent supply
E Vacuum nozzle
F Nozzle for internal standard supply
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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.
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A-80 Operator’s Manual · Version 2.0
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Flow of ISE analysis
4 cobas ISE module
The workflow below describes an ISE measurement sequence in single steps.
ISE Measurement sequence
Top view
IS REF
IS REF
Sample + DIL REF
Cleaning the vessel
1.
2.
Dispensing IS into the vessel
Draining IS-solution
Calibration REF
3. Dispensing REF and transport to the
REF - electrode
Measuring resulting signal
Calibration Cl
-
, K
+
, Na
+
4./
5.
Dispensing IS and transport to the
Cl , K + signal
, Na + - electrodes
Measuring and checking resulting
6. Draining IS-solution
+
, Na
+
Measuring Cl
-
, K
7.
8.
Dispensing sample
Adding diluent and mixing
10. Transport diluted sample to the Cl
-
,
K
+
, Na
+
- electrodes
Measuring resulting signal
6. Draining REF - solution
Measuring REF
9. Dispensing REF and transport to the
REF - electrode
Measuring resulting signal
Calculating the result in relation to the REF-signal
Sample + DIL REF
11. Draining solutions
Figure A-52 ISE measurement sequence
End of ISE sequence
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Front view – behind the door
Front view – behind the door
The ISE module as seen behind the door: cobas ® 8000 modular analyzer series
A
B
C
A Drain ports
B Syringes for reagents and samples
Figure A-53 Components behind the front door
C 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 for reagents and samples
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 sensitive electrodes and drains after a measure cycle is final.
e
For more information, see Syringes on page A-83
ISE reagents The ISE reagents are located at the bottom of the module. e
For more information, see ISE reagents on page A-84
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A-82 Operator’s Manual · Version 2.0
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Front view – behind the door
Syringes
The sample syringe is filled with degassed and deionized water. The syringe aspirates and dispenses samples via the sample probe.
The reagent syringes aspirate and dispense reagent by means of positive displacement generated by the reagent syringes.
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 in a ratio of 1:31 with the sample.
Syringes and ISE reagents in detail
Unit 2
C content of the reagent containers:
A
B
Presented below are detailed illustrations about the function of every syringe and the
G
D
E
F
A Syringe IS-2
B Syringe DIL-2
C Syringe SIP-2
Figure A-54
D REF - Reference solution
E DIL-2 - Diluent
F IS-2 - Internal standard solution
G Sample syringe
ISE reagents for measuring unit 2
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Operator’s Manual · Version 2.0
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Front view – behind the door
Unit 1 cobas ® 8000 modular analyzer series
A
B
C
G
D
E
F
A Syringe IS-1
B Syringe DIL-1
C Syringe SIP-1
D REF - Reference solution
E DIL-1 - Diluent
F IS-1 - Internal standard solution
Figure A-55
G Sample syringe
ISE reagents for measuring unit 1
ISE reagents
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 past the three ion sensitive 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 sensitive electrodes. IS- and sample measurement will be performed alternately. Combined calculation of both measurements will result into the searched ion concentration values of an individual sample.
Since the IS properties are stable, it is used to compensate any change in temperature.
e Changing ISE reagents is described in chapter
To replace an ISE reagent container on page B-107.
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.
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Rear view
The ISE module as seen from the rear side:
4 cobas ISE module
Rear view
A
B
D
C
A Liquid level sensor assembly
B Waste container
Figure A-56
C
D
Power inlet
Power circuit breaker
ISE components as seen from the rear side
Liquid level sensor assembly Sensor to detect the maximum waste level.
Waste container Waste container of the ISE.
Power circuit breaker The power circuit breaker has two tasks: o Protecting the module in the case of an internal electrical short o
Powering OFF the module - for service purposes only! Leave this function to
Roche representative only, except in case you are requested to do so, e.g. during a maintenance procedure or in case of emergency.
Power inlet The mains supply of the ISE module is connected here.
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Rear view cobas ® 8000 modular analyzer series
Roche Diagnostics
A-86 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
cobas c 701 module
5 cobas c 701 module
Table of contents
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 · Version 2.0
A-87
5 cobas c 701 module
Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
A-88 Operator’s Manual · Version 2.0
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 2000 tests per hour. The related module sample buffer module offers a random access buffer function for samples.
Components of the cobas c 701 module
A Module sample buffer c 701 module Figure A-57
A B
B Module c 701
The c 701 module can be subdivided into the following areas: o Sampling area e
See Sampling area on page A-91
o Reagent area e
o Reaction disk area e
See Reaction disk area on page A-94
o Components behind the front doors e
See Front view – behind the doors on page A-99
o Components at the rear side of the module e
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Top view
Top view
cobas ® 8000 modular analyzer series
Presented below is the c 701 module as seen from the top.
Figure A-58 c 701 top view
The top of the c 701 module includes the sampling, reagent and reaction disk areas.
The following sections describe these areas.
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A-90 Operator’s Manual · Version 2.0
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Sampling area
5 cobas c 701 module
Top view
The sample area is in charge of transporting sample fluid between a sample tube and an individual reaction cuvette. Two sample pipetters are available in this section.
Sample area
A B C D E
Figure A-59
A Sample pipetter B
B Rinse station B
C Sample Cleaner 1
Sample components as seen from the rear side (safety cover removed)
D Sample Cleaner 2
E Rinse station A
F Sample pipetter A
Sample pipetter A and B Transports liquid which is aspirated from sample tubes.
F
Rinse station A and B Cleans inside and outside of the probes after an individual sample has been processed. This will prevent any carry over between individual samples.
Sample Cleaner 1 Is used as basic cleaning solution.
Sample Cleaner 2 Is used as acid cleaning solution.
Sample pipetters
The sample processing area is in charge of transporting sample material to individual reaction cells (also called cuvettes ). Two sample pipetters are available for the c 701 module. Each sample pipetter consists of the pipetter arm and the sample probe.
When a rack is in the sampling position, the pipetter transports sample liquid from the sample tube to a reaction cell. When aspirating, liquid level detection is accomplished by a highly sensitive capacitance measurement, as well as a 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.
A-91
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Top view
Sample probe rinse stattion cobas ® 8000 modular analyzer series
The sample probe rinse station is located between the sample aspiration position and at the reaction disk. To prevent carryover, the sample probe is rinsed with deionized water both externally and internally before aspirating a new sample.
Reagent area
The reagent area is in charge of transporting reagents to individual reaction cuvettes.
Four reagent pipetters are available in this section.
A B C D E F
Reagent pipetter area
Figure A-60
RFID readers A + B
B R2, R3 Reagent pipetter of disk A
A Reagent disk A
C R1 Reagent pipetter of disk A
Reagent components of the c 701 modules top section
D R1 Reagent pipetter of disk B
E R2, R3 Reagent pipetter of disk B
F Reagent disk B
Reagent disk A, B Two round compartments to accommodate all reagent packs. Both compartments are refrigerated and temperature controlled and protected by individual covers that must be locked when closed. Additionally, each cover has an integrated RFID
(Radio Frequency IdentiFication) reader.
R1, R2, R3 Reagent pipetters of disk A, B
Two rotating pipettes on each disk to transport R1, R2 and R3 reagents. The reagent probe is equipped with a level detector that uses a highly sensitive sensor. When a new reagent pack is loaded, this sensor checks the reagent level for every container of the reagent pack. This initial volume check is referred to as IPVC ( Initial reagent pack volume check ) check.
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Top view
Reagent storage compartment
Reagent packs are loaded manually in two refrigerated compartments for disk A and B. They are identified by an RFID label.
To load reagent packs, loose the screw and lift off the cover. Place reagent packs
manually as indicated in Figure A-61. Close the cover and tighten the screw.
e
A
RFID label
B
Figure A-61
Top view of a reagent pack with an RFID label attached
A RFID reader unit disk A B RFID reader unit disk B
Reagent loading at disk B (as an example) with the protection cover removed
The total capacity of both reagent disks is up to 70 reagent packs.
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)
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.
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Top view cobas ® 8000 modular analyzer series
The mechanical circle of the cobas c 701 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 timing.
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. After that the probes are dried.
The rinse stations are the home position for the reagent probes when the module is in
Standby.
Reaction disk area
Reaction disk
The reaction disk area of the c 701 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 The auxiliary reagents SmpCln 1 (basic wash), SmpCln 2 (acid wash), and
Hitergent.
The reaction disk of the c 701module carries 406 reusable plastic reaction cells (also called cuvettes ). These reaction cells are grouped together in sixteen 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.
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.
e See
To perform a cell blank measurement on page D-130.
Ultrasonic mixers
Ultrasonic mixing units
(reaction cuvettes removed)
The ultrasonic mixing units mix the reagents within each of the reaction cuvettes to ensure a homogeneous distribution between sample and reagent fluid.
Corresponding to the three reagent timings R1, R2, and R3, there are six independent mixing units.
To avoid any spillage, the liquid level in the cuvettes is checked before the mixing process starts. If the liquid level is too low or too high, an alarm is issued and mixing is not performed.
Contamination on the surface of the ultrasonic mixing units will cause inadequate mixing.
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 the replacement.
Operator’s Manual · Version 2.0
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Top view
Incubator bath
Reaction cuvette segment, shortly before passing the photometer windows
The analyzer controls the temperature of incubator bath water so that the reaction solution is kept at a constant temperature of 37
°
C (98.6
°
F).
Water in the incubator bath is continuously circulated by a pump. Its temperature is permanently controlled to ensure a deviation of a maximum of
±
0.1
°
C (
±
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.
Hitergent Hitergent is a non-ionic, bacteriostatic detergent automatically added to the incubator bath whenever the water is exchanged. It acts as a surfactant to minimize the formation of bubbles that could interfere with the photometer readings and, additionally, it will prevent the propagation of microbes. Hitergent is placed in reaction disk B.
Photometer
Photometer lamp - cover open
The c 701 module is equipped with a photometer to measure the absorbances of the reaction mixtures in the reaction cuvettes.
The photometer lamp is located outside of the incubator bath ring. The detector is located inside of the incubator bath ring.
e
To locate the photometer unit, see Figure A-60 on page A-92.
Measurements are taken of all 406 reaction cuvettes, as the reaction ring is turning.
A B C D E F G H I J K L M
Roche Diagnostics
Operator’s Manual · Version 2.0
N
A Photometer lamp
B Water jacket
C Infrared cut filter
D Mask
E Condenser lens
Figure A-62
I
F
G
H
J
Slit (IN)
Incubator bath
Cuvette and dispersion
Slit (OUT)
Imaging lens
K
L
M
N
Slit
Photometer unit
Diffraction grating
Detector
Illustration of light path through photometer components
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Top view
Photometer lamp The photometer lamp is encased in a constant-temperature water jacket, which helps to maintain a constant energy output from the lamp, and also extends the lamp life.
e
Light path The light from the photometer lamp passes through the following main components: o Outer incubator bath window o
Incubator bath water o Reaction cuvette and its contents o
Incubator bath water o Inner 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 individual wavelengths and reflects them onto a fixed array of
12 photodiodes. Each diode is mounted in a fixed position to detect light at an individual wavelength.
The computer 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.
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Top view
Cell rinse units
3
Position of the cell rinse units
2
Rinsing and cleaning of the reaction cuvettes is continuous in order to reuse of all cuvettes. A cell blank of each cuvette guarantees the perfect condition of all cuvettes within small tolerances. If any individual cuvette does not meet these predefined limits, it will be disabled for routine use.
The illustration below shows individual rinse units and their nozzle outfit:
Rotation direction of the reaction ring
1
A B C D E F G H I J K L
Cell blank measurement
M N
Rinse unit 3 Rinse unit 2 Rinse unit 1
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 A-63 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
Nozzle functions The nozzle shape is designed, according to their function. Presented below is an overview of nozzles and their functions:
Roche Diagnostics
Operator’s Manual · Version 2.0
A B
A Aspiration of liquids
B Discharging and aspiration liquids
Figure A-64 Nozzle functions
C
C Cuvette drying
The Teflon
tip of shape C is optimized for perfect drying of the cuvette.
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Top view cobas ® 8000 modular analyzer series
Flow of photometric analysis
Start of a measurement sequence
The workflow presented below illustrates a single measurement sequence:
After start, the instrument mechanism will be moved to its default position and starts rinsing the reaction cell.
The reaction ring is continuously rotating. Alternating between sample probe A and B, every
1.8 seconds a test sequence is initiated. The rinsing nozzle A aspirates reaction mixture from the reaction cell. Additionally the reaction cell is rinsed with deionized water using rinsing nozzles B/C .
Default position of mechanism
Cleaning the reaction cell
Then, after 4 cycles, the reaction cell is washed with rinsing nozzles D/E in the rinsing mechanism using CellCln 1. After another 4 cycles, the reaction cell is washed with rinsing nozzles F/G in the rinsing mechanism using CellCln 2.
Using the rinsing nozzles H/I , the reaction cell is rinsed with deionized water. Again deionized water is discharged with nozzle J , it is aspirated with nozzle K .
Water blank measurement
The rinse nozzle L dispenses a water blank discharge. A water blank is measured 3 times.
If the water blank value differs by 0.1 or more from the cell blank value, that cell will not be used for analysis.
Discharging of water
Dispensing of sample
Adding R1 - mixing
After rinsing and water blank measurement are done, the reaction cell returns to the sampling position.
The sample with the longest processing time is assayed first to get results out quickly.
Discharging of water and dispensing of sample starts.
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 has been added, the fluid in the cell is mixed at the corresponding mixing position by means of the ultrasonic mixer.
Adding R2 - mixing
Adding R3 - mixing
Calculating the result
16.2 s - photometric cycle time
1.8 s - sampling time
3.6 s - sampling time per sample probe (A or B)
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 by use of the absorbance at the specified points of the reaction process.
Cleaning the reaction cell
The instrument aspirates the reaction solution using the cell rinse units performing the washing sequence with detergent and rinsing with water afterwards.
Automatic STOP
Figure A-65
End of the measurement sequence
Then the instrument goes into Standby.
Workflow of a measurement sequence
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Front view – behind the doors
Front view – behind the doors
This section presents all elements which are located behind the front doors.
A B
A System syringes
C
C Refrigerator condenser filter
B Components used for maintenance
D Detergent bottles (Cell cleaner 1 and 2)
E Drain ports for condensation water in the vacuum system
Components behind the front doors Figure A-66
D E
System syringes These syringes are in charge of transporting reagent and sample liquid.
Refrigerator condenser filter Dust filter of the refrigerator unit.
Components used for maintenance
These controls and status LED are used for maintenance only.
Drain ports These two ports are used to drain the two tank compartments of the vacuum system.
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Front view – behind the doors
Maintenance controls
cobas ® 8000 modular analyzer series
A B C
A Control LEDs
B Maintenance tap
Figure A-67
C Maintenance push buttons
Components used during maintenance
Control LEDs These LEDs show the status of the individual internal power supplies. The green color indicate, that all power supplies are working properly.
Maintenance tap This tap is used to drain the incubator bath during maintenance.
Maintenance push buttons These push buttons are used for maintenance purposes. Depending on the selected maintenance item, the function of these button changes. They 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 plastic nose at the nozzle tip.
o To move the reagent probes horizontally.
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Syringes
5 cobas c 701 module
Front view – behind the doors
A B
A R1 syringe - disk A
B R2, R3 syringe - disk A
C R1 syringe - disk B
Figure A-68 System syringes
C D E
D R2, R3 syringe - disk B
E Syringe sample pipetter A
F Syringe sample pipetter B
F
R1 syringe - disk A, B Aspirates the determined volume of reagent R1 and discharges it into a reaction cuvette.
R2, R3 syringe - disk A, B Aspirates the determined volume of reagent R2, R3 and discharges it into a reaction cuvette also according to the test setup.
Syringe sample pipetter A, B Aspirates the determined volume of sample fluid and discharges it into a reaction cuvette. Equipped with a pressure sensor between the probe and the pipetter in order to monitor sample-aspirating state and to detect clots.
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Front view – behind the doors
Detergents and filter
A B C
A Refrigerator condenser filter
Figure A-69
B Cell cleaner 1 (CellCln 1)
C Cell cleaner 2 (CellCln 2)
Components used during maintenance - B
Refrigerator condenser filter Air protection filter. Must be cleaned regularly.
Cell cleaner 1 Basic detergent for cleaning purposes.
Cell cleaner 2 Acid detergent for cleaning purposes.
Vacuum system
The vacuum system is located behind the front section of the module. It consists of two vacuum pumps, vacuum tanks, vacuum sensors, and connecting tubing.
The vacuum system aspirates reaction mixture waste from the reaction cuvettes to the reaction waste container and removes reaction cuvette rinse water from the module through the main drain line.
As part of the maintenance, the vacuum system must be checked routinely.
e
To locate the drain ports of the vacuum system, see Figure A-66 on page A-99.
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Rear view
The c 701 module as seen from the back:
5 cobas c 701 module
Rear view
A Waste drain
B High concentration waste drain
C Liquid level sensor assembly
D Water tank
Figure A-70 c 701 rear view
A B C D
E Power inlet
F Power circuit breaker
G Water inlet
Waste drain Main drain outlet - connected to a drain pipe.
Waste drain - high concentrated Waste outlet for high concentrated waste - connected to a drain pipe. Needs special treatment according to local regulations.
F
E
Water tank This tank will buffer peak water consumptions during routine work.
Power inlet Mains supply will be connected here.
Water inlet Main water supply.
Liquid level sensor assembly Water tank cap with a float for the integrated level control.
G
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Roche Diagnostics
A-104 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
cobas c 502 module
6 cobas c 502 module
Table of contents
Roche Diagnostics
Operator’s Manual · Version 2.0
This chapter provides a detailed description of the c 502 module, its hardware components and technical specifications.
In this chapter Chapter
6
Reagent pack management system ............................................................... A-112
A-105
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Table of contents cobas ® 8000 modular analyzer series
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A-106 Operator’s Manual · Version 2.0
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Overview
6 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 600 tests per hour. The related module sample buffer offers a random access buffer function for samples.
A
A Module sample buffer
Figure A-71 c 502 module
B
B c 502 module
This chapter describes the c 502 module. The module sample buffer belongs to the core unit.
e
For a detailed description of the core unit, see Core unit on page A-56.
Components of the cobas c 502 module
The c 502 module can be subdivided into the following areas o Sampling area e
See Sampling area on page A-109.
o Reagent area e
See Reagent area on page A-110.
o Reaction disk area e
See Reaction disk area on page A-114.
o Components behind the front doors e
See Front view – behind the doors on page A-121.
o Components at the rear side of the module e
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Top view
Top view
cobas ® 8000 modular analyzer series
Presented below is the c 502 module as seen from the top.
A
B
A Sampling area
B Reaction disk area
Figure A-72 Areas of the c 502 module
C Reagent area
D Reagent pack loading port
The top of the c 502 module includes the sampling, reagent and reaction disk areas.
D
The following sections describe these areas.
C
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Sampling area
6 cobas c 502 module
Top view
The sampling area of the c 502 module consists of the following components: o Rack sampling position.
o
Sample pipetter to transport sample from the sample tubes to the reaction cells on the reaction disk.
o Rinse station for internal and external rinsing of the sample probe.
C D E
A
B
Rinse station
F
Figure A-73
G
Cleaner area
A Shield pipe (against electrostatic noise)
B Sample pipetter
C Drying position
D Sample probe (in detail)
Sample pipetting system
Sample pipetter
E Rinse station
F 1 - Sample Cleaner 1
G 2 - Sample Cleaner 2
The 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. The sample probe is equipped with liquid level detection (sensitive capacitance) and clot detection (pressure sensor).
To protect the probe against electrostatic noise, which could interfere with the capacitance measurement, a metal shield pipe is mounted over the sampling position.
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.
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Top view
Sample probe rinse station cobas ® 8000 modular analyzer series
The sample probe rinse station is located between the sample aspiration position and at the reaction disk. To prevent carryover, the sample probe is rinsed with deionized water both externally and internally before aspirating a new sample.
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.
Reagent area
The reagent area of the c 502 module consists of the following components: o A refrigerated reagent compartment for storing up to 60 reagent packs.
o Two reagent pipetters for aspirating and dispensing reagents.
o Two rinse stations for internal and external rinsing of the reagent probes.
Reagent storage compartment
A
B
C
D
E
A Reagent preparation station
B Reagent compartment flap
C Cutouts for R1 reagent pipetter probe
Figure A-74 c 502
D Reagent compartment (cover closed)
E Cutouts for R2 reagent pipetter probe 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.
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Reagent pipetters
6 cobas c 502 module
Top view
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
Figure A-75 Reagent pipetters
A R2 pipetter
B R1 pipetter
C Reagent preparing station
D Rinse stations
D
Two reagent pipetters which are mounted above the reagent disk, transport the reagents from the reagent compartment into the reaction disk.
Before each pipetting, the reagent probes are externally and internally rinsed with deionized water and dried. 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 probes are not lowered into the reaction cell.
The mechanical cycle of the c 502 module allows for three different reagent timings:
R1, R2, and R3.
Only R1 reagent probe is equipped with a level detector. This detector works with a pressure sensor and is used when a new reagent pack is loaded and checked at the preparation station. The R1 reagent probe, the gripper and the piercer are mounted on the same XY-transport.
e See
Reagent pack preparation station on page A-113.
Reagent probe rinse stations The reagent probe rinse stations are located between the reagent compartment and the reaction disk. After each reagent dispense, deionized water is flushed through the probes and onto their outside surfaces. After that the probes are dried.
The rinse stations are the home position for the reagent probes when the module is in
Standby.
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Top view cobas ® 8000 modular analyzer series
Reagent pack management system
Reagents for all Roche Diagnostics applications 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 - Reagent pack disposal port
Figure A-76
C
A Reagent pack loading port
B Reagent pack table - turned down
Components of the reagent pack management system
C Reagent pack disposal port
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Top view
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.
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.
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 system proceeds with the following actions while the reagent pack is at the preparation station: o
By reading the reagent pack barcode, the system checks the availability of the corresponding test application.
o The piercer pierces the reagent bottle caps.
Now, the reagent pack is ready to be transported to the reagent compartment by the gripper.
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 pierces 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
Do not touch piercer and 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.
e
To locate the reagent pack disposal, see Figure A-76 on page A-112.
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Top view
Reaction disk area
Reaction disk
B
The reaction disk area of the c 502 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 The auxiliary reagents SmpCln 2 (acid wash), SmpCln 1 (basic wash), and
Hitergent.
A presentation of the major parts of the reaction disk is given below:
H
A
G
C
A Reaction disk rotor
B Reaction cell – an individual segment
C Interlock unit
D Hitergent area
Figure A-77 Reaction disk – c 502
D E F
E Photometer lamp
F Incubator bath
G Ultrasonic mixers
H Water level sensor
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.
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.
e See
To perform a cell blank measurement on page D-130.
Operator’s Manual · Version 2.0
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Top view
Ultrasonic mixers
The ultrasonic mixing units mix the reagents within each of the reaction cells to ensure a homogeneous distribution of reactants.
e For more information, see:
Ultrasonic mixers on page A-94
Cleaning the ultrasonic mixers on page D-151.
Incubator bath
The circular incubator bath is filled with temperature controlled water. Located beneath the reaction disk, it keeps the reaction mixtures in every reaction cell at a temperature of 37
°
C (
±
0.1
°
C).
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. Due to evaporation deionized water is added into the incubator bath.
Hitergent reagent Hitergent is a non-ionic, bacteriostatic detergent automatically added to the incubator bath by the Hitergent pipetter whenever the water is exchanged. It acts as a surfactant to minimize the formation of bubbles that could potentially interfere with the photometer readings. The reagent bottle of the Hitergent is located beside the reaction disk.
A
B
Figure A-78
C
Hitergent pipetter
A Hitergent probe
B Hitergent pipetting position
Roche Diagnostics
Operator’s Manual · Version 2.0
C Hitergent reagent bottle
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Top view
Photometer cobas ® 8000 modular analyzer series
The c 502 module is equipped with a photometer to measure the absorbencies of the reaction mixtures in the reaction cells.
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.
e
To locate the photometer unit, see Figure A-77 on page A-114.
Measurements are taken of all the 160 reaction cells, as the reaction disk is turning.
A B C D E F G H I J K L M
F Slit (IN)
G Incubator bath
H Cuvette and dispersion
I Slit (OUT)
J Imaging lens
N
A Photometer lamp
B Water cooled case
C Infrared cut filter
D Mask
E Condenser lens
Figure A-79
K
L
M
N
Slit
Photometer unit
Diffraction grating
Detector
Illustration of light path through photometer components
Photometer lamp The photometer lamp beneath the reaction disk is assembled in a water cooled case.
This design ensures a constant energy output from the lamp. Additionally it will extend the lamps shelf life.
e
Roche Diagnostics
A-116
Light path The light from the photometer lamp passes through the following main components: o
Inner incubator bath window o Incubator bath water o
Reaction cell and its contents o Incubator bath water o
Outer incubator bath window o ...and into the photometer
When the light beam enters the photometer, it strikes a diffraction grating. This separates the light into its constituent wavelengths and reflects them onto a fixed array of 12 photodiodes. Each photodiode is permanently positioned to detect light at a different wavelength.
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.
Operator’s Manual · Version 2.0
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Top view
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. The control unit uses this tracking ability and the programmed read instructions to obtain test results.
Cell rinse unit
A
B
A Cell rinse unit
Figure A-80 Reaction cell rinsing system
B Cell rinse nozzles
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 cell optical performance, the absorbances of water filled cells are measured during the cleaning process (cell blank) and compared with the previous readings.
Cell rinse sequence The following sequence reflects the order in which cleaning, rinsing, and cell blanking of the reaction cells takes place.
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Top view cobas ® 8000 modular analyzer series
Rotation direction of the reaction ring
A B C D E F G
Cell blank measurement
H I
Rinse unit
G F E D C B A
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
Figure A-81 Flow of the cell rinse mechanism
H I
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)
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Top view
Flow of photometric analysis
Start of a measurement sequence
The workflow presented below illustrates a single measurement sequence:
After start, the instrument mechanics will be moved to its default position and start rinsing the reaction cell.
The reaction ring is continuously rotating. Every 6 seconds a sample sequence is performed. The rinsing nozzle A aspirates reaction mixture from the reaction cell. Additionally the reaction cell is rinsed with deionized water.
Default position of mechanics
Cleaning the reaction cell
Then, after 4 cycles, the reaction cell is washed with rinsing nozzle B in the rinsing mechanism using CellCln 1. After another 4 cycles, the reaction cell is washed with rinsing nozzle C in the rinsing mechanism using CellCln 2.
Using the rinsing nozzle D and the rinsing nozzle E , the reaction cell is rinsed again with deionized water. After deionized water is discharged with nozzle F , it is aspirated with nozzle G .
Water blank measurement
The rinse nozzle G dispenses a water blank discharge. A water blank is measured 3 times.
If the water blank value differs by 0.1 or more from the cell blank value, that cell will not be used for analysis.
Discharging of water
Dispensing of sample
After rinsing and water blank measurement are done, the water is aspirated and the related cells are dried. The reaction cell turns to the sampling position.
The sample with the longest processing time is assayed first to get results out quickly.
Discharging of water and dispensing of sample starts.
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 has been added, the fluid in the cell is mixed at the corresponding mixing position by means of the ultrasonic mixer.
Adding R1 - mixing
Adding R2 - mixing
Adding R3 - mixing
6 s - sampling time
8.6 s - measuring time
A measurement is performed every 6 seconds. Measurement is performed 70 times/cell in
10 minutes. After all measurements are final, the concentration is calculated by use of the absorbance at the specified point of the reaction.
Calculating the result
Cleaning the reaction cell
The instrument discharges the reaction solution by rinsing it and performs a washing sequence with detergent and rinsing with water afterwards.
Automatic STOP
Figure A-82
End of the measurement sequence
Then the instrument goes into Standby.
Workflow of a measurement sequence
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Top view
Maintenance push button
cobas ® 8000 modular analyzer series
A
Maintenance push button
Figure A-83
A Maintenance push button
Maintenance push button
The maintenance push button is located beside the Hitergent probe. It is used to move a pipetter probe to predefined positions to check its horizontal alignment.
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Front view – behind the doors
Front view – behind the doors
Figure A-84 provides a front view of the
c 502 module and lists the main components behind the front doors of the module.
A
B
A Sample and reagent syringes
C D
B Cell detergents (CellCln 1 and CellCln 2)
C Drain port for condensation water of the vacuum system
Figure A-84 Components behind the front doors
E
D Vacuum system (hidden)
E Reagent pack disposal
F Cooling unit
F e For more information about the cell detergents, see:
Auxiliary reagents (cobas c 502 module) on page B-127
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Front view – behind the doors
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.
A B C D
A Sample syringe
B Reagent syringe R1
Figure A-85 Location of syringes
C Reagent syringe R2
D Hitergent syringe
Sample syringe The sample syringe is filled with degassed and deionized water. The syringe uses positive displacement to aspirate and dispense samples via the sample probe.
The syringe motor retracts the plunger within the chamber of the syringe, and sample is aspirated into the tip of the sample probe. The pipetter arm moves the sample probe to the reaction disk. The sample probe lowers into the reaction cell and the syringe motor reverses to dispense the sample. The pipetter arm lifts the sample probe from the reaction cell and moves it to the sample probe rinse station.
Reagent syringes The reagent syringes are filled with degassed and deionized water, using positive displacement to aspirate and dispense reagents.
Hitergent syringe By using positive displacement, this syringe aspirates and dispenses Hitergent into the incubator bath in order to prevent contamination by bacteria and formation of bubbles.
Detergents and filter
Two large bottles with detergents for the cell rinse process are located behind the left front door of the c 502 module. They contain Cell Wash Solution I (CellCln 1) and
Cell Wash Solution II (CellCln 2).
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Vacuum system
6 cobas c 502 module
Rear view
The vacuum system is located at the front of the module. It consists of vacuum pump, vacuum tank, 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.
Rear view
Figure A-86 provides a rear view of the
c 502 module and its main components.
G
F
E
D
A Waste drain - diluted
B Waste drain - high concentrated
C Water tank
A B C
D Power inlet
E Power circuit breaker
F Liquid level sensor assembly
G Maintenance tap
Figure A-86 c 502 rear side view
Waste drain Main drain outlet - connected to a drain pipe.
Waste drain - high concentrated Waste outlet for high concentrated waste - connected to a drain pipe. Needs special treatment according to local regulations.
Water tank This tank will buffer peak water consumptions during routine work.
Power inlet Mains supply will be connected here.
Power circuit breaker Switch to power the module ON/OFF and protection in case of an internal electrical short.
Liquid level sensor assembly Water tank cup with a float for the level control integrated.
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Rear view cobas ® 8000 modular analyzer series
Roche Diagnostics
A-124 Operator’s Manual · Version 2.0
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cobas e 602 module
7 cobas e 602 module
Table of contents
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
7
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Table of contents cobas ® 8000 modular analyzer series
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A-126 Operator’s Manual · Version 2.0
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Overview
7 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.
Figure A-87 core unit.
e 602 module
This chapter describes the e 602 module. The module sample buffer belongs to the e
For a detailed description of the core unit, see Core unit on page A-41.
Components of the e 602 module
The e 602 module can be subdivided into the following areas: o Reagent area e
See Reagent area on page A-130.
o Measuring area e
See Measuring area on page A-132.
o Pre-wash area e
See Pre-wash area on page A-129.
o Consumables area e
See Consumables area on page A-135.
o Components behind the front doors e
See Front view – behind the doors on page A-136.
o Components at the rear side e
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Top view
Top view
cobas ® 8000 modular analyzer series
The different areas of the e
602 module are shown in Figure A-88 from a top view
perspective.
A
C
B
A Pre-wash area
B Reagent area
Figure A-88 e 602 module – top view
C Measuring area
(incubator and measuring unit)
D Consumables area
The top of the e 602 module includes the pre-wash, reagent, measuring, and
D consumables areas. The following sections describe these areas.
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Pre-wash area
7 cobas e 602 module
Top view
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.
It consists of the following components:
A B C D E F
Figure A-89
A Dispenser
B Sipper
C Rinse station
Components of the Pre-wash area
D Separation stations
E Vortex mixing station
F Gripper
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.
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.
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Top view cobas ® 8000 modular analyzer series
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.
Reagent area
The reagent area is on the left side of the analytical module and consists of the following components:
D E F
C
G
Figure A-90
H
B
Reagent area components
A
A Reagent disk
B Barcode reader
C Reagent cap open/close mechanism
D Microbead mixer rinse station
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.
Diluent or pretreatment reagents 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 utilizes a reagent cap open/close mechanism during reagent pipetting. 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 system can be configured to open caps prior to pipetting or mixing the specific reagent (e.g. R1, R2, or M) and close them again afterwards.
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Top view
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.
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7 cobas e 602 module
Top view
Measuring area
cobas ® 8000 modular analyzer series
The measuring area is in the middle of the analytical module and consists of the following components:
A
B
C
Figure A-91
CAUTION
D
A Sample probe
B Incubator disk
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.
Incorrect results due to residues on the sample probe
Residues on the sample probe seriously affect the probe performance.
Do not touch the surface of the sample probe with bare hands as this leaves residues on the probe. 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.
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
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Top view 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
C
B
A
A Cell body
B Top cell
C Counter electrode
D Reference electrode
Figure A-92 Measuring cell
H G F
E Outlet
F Working electrode
G Movable magnet
H Inlet
E
D
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.
e For more details refer to the chapter e 602 module – ECL technology on the COBI-CD.
Flow of immunoassay analysis
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.
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cobas ® 8000 modular analyzer series 7 cobas e 602 module
Top view
Start of a measurement sequence
After start, the instrument mechanic moves to its default position.
Every 21 seconds a sample sequence is performed.
Mechanism in default position
Preparation
Adding R1 / R2
Adding sample – mixing
The xyz arm (gripper) transports an AssyTip into the AssayTip station and an AssayCup into the incubator.
The reagent probe aspirates R1, is rinsed at the rinse station and aspirates R2.
Then R1/R2 are dispensed into the AssayCup.
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.
Adding microbeads - mixing
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.
Before the second incubation is completed, the sipper probe aspirates ProCell into the measuring cell to facilitate measurement.
Preparing measuring cell
Aspirating reaction mixture
The sipper probe aspirates 130
μ l of the reaction mixture.
The gripper pick up and transports the AssayCup to the cup disposal opening and discards the cup.
Calculating the 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.
Cleaning measuring cell
After measurement, the measuring cell is rinsed with CleanCell and ProCell.
Figure A-93
End of measurement sequence
Then the instrument goes into Standby.
Workflow of a measurement sequence
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Consumables area
7 cobas e 602 module
Top view
The components of the consumables area are located on the right of the analytical module.
C
D
A
Figure A-94
B
A Gripper
B Green status lamp
Consumables area components
C AssayTip buffer station with disposal opening
D Vortex mixing station
Some components of the consumables system are behind the right front door of the module.
e
For more information about these components, see Consumables components on page A-140.
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.
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7 cobas e 602 module
Front view – behind the doors cobas ® 8000 modular analyzer series
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
Front view – behind the doors
This section presents all elements located behind the front doors.
A B C
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A-136
A Auxiliary reagents and cleaning solutions
B Syringes
Figure A-95
C Consumables components
Components behind the front doors
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Syringes
A
7 cobas e 602 module
Front view – behind the doors
B
C
A Reagent syringe B Sample syringe
C Sipper syringes
Figure A-96 Syringes
Reagent syringe The reagent syringe is located on the left behind the front door of the analytical module. The syringe is filled with deionized water and uses positive displacement to aspirate and dispense from the reagent probe.
Sample syringe The sample syringe is located on the right behind the front door of the analytical module. The syringe is filled with deionized water and uses positive displacement to aspirate and dispense from the sample probe.
Sipper syringes The sipper syringes are located on the right behind the front door of the analytical module. The pipetters are filled with deionized water and use positive displacement to aspirate and dispense from the sipper probes.
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7 cobas e 602 module
Front view – behind the doors 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 A-97
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 each reagent 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 are available in case of inaccurate counting due to incorrect loading of
PreClean bottles.
e See
Loading auxiliary reagents (cobas e 602 module) on page B-144.
CAUTION
Personal injury due to contact with PreClean needles
Do not put your hand into the PreClean bottle holders as the needles are sharp and could cause injury.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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Front view – behind the doors
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.
e See
Loading auxiliary reagents (cobas e 602 module) on page B-144.
If a ProCell bottle is replaced, the lot number of the new bottle must be entered into the system.
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7 cobas e 602 module
Front view – behind the doors
Consumables components
cobas ® 8000 modular analyzer series
A
A Magazine lifter
B C
B Solid waste container
C Magazine waste compartment
Figure A-98 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.
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Rear view
7 cobas e 602 module
Rear view
Figure A-99 provides a rear view of the
e 602 module and its main components.
E
D
A B C
A Waste drain
B Waste drain - high concentrated
C Water tank
Figure A-99 e 602 rear side view
D Power inlet
E Power circuit breaker
Waste drain Main drain outlet - connected to a drain pipe.
Waste drain - high concentrated Waste outlet for high concentrated waste - connected to a drain pipe. Needs special treatment according to local regulations.
Water tank This tank buffer peak water consumptions during routine work.
Power inlet Mains supply is connected here.
Power circuit breaker Switch to power the module ON/OFF and protection in case of an internal electrical short.
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7 cobas e 602 module
Rear view cobas ® 8000 modular analyzer series
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A-142 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Specifications
8 Specifications
Table of contents
This chapter gives an overview of the specifications of the cobas® 8000 instrument and its components.
Roche Diagnostics
Operator’s Manual · Version 2.0
In this chapter Chapter
8
A-143
8 Specifications
Table of contents cobas ® 8000 modular analyzer series
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A-144 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 8 Specifications
System specifications
System specifications
The following specifications apply to the cobas® 8000 modular analyzer series.
Dimensions
Depth
Module
Core unit
Layout Width × Height × Depth
910
×
1080
×
950 mm
(35.8
×
42.5
×
37.4 in)
Weight
190 kg
(400 lb)
Height
Width
Dimension directions
ISE module
450
×
1150
×
1140 mm
(17.7
×
45.3
×
44.9 in)
175 kg
(385.8 lb) c 701
1500
×
1350
×
1170 mm
(59.1
×
53.1
×
46.1 in)
655 kg
(1444 lb)
1500
×
1350
×
1170 mm
(59.1
×
53.1
×
46.1 in) c 502
510 kg
(1124.4 lb)
1500
×
1145
×
1170 mm
(59.1
×
45.1
×
46.1 in)
545 kg
(1201.5 lb) e 602
Table A-6 Dimensions and weights of the cobas® 8000 modules
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cobas ® 8000 modular analyzer series 8 Specifications
System specifications
Operating conditions
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
> 12
°
C o must provide
≥
80 L/h o c 701 module: approx. 40 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 Power rating
Power supply fluctuation
Overvoltage category
Pollution degree
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 (incl. MSB): 3 kVA c 502 (incl. MSB): 2.5 kVA e 602 (incl. MSB): 3 kVA
Electrical shock by electronic equipment o The power supply must be grounded. o The instrument must only be connected to a power supply source with the specified power supply cable and only by authorized personnel.
WARNING
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.
o Comply with the specifications for electrical installation.
CAUTION
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cobas ® 8000 modular analyzer series 8 Specifications
System specifications
Environmental conditions
The following environmental conditions should be followed in order to ensure correct operation of this system:
Ambient temperature
Ambient humidity
Waste volume
Installation altitude
Noise emission
Other environmental conditions
During operation: o 18 to 32
°
C (64.4 to 89.6
°
F) with changes <
±
2
°
C/h (
±
3.6
°
F/h)
During operation: o 30-85% (non-condensing) o c 701 module: approx. 2.4 L/h concentrated waste solution including wastes of ISE tests o c 502 module: max. 2.5 L/h concentrated waste solution and max. 37.5 L/h diluted waste solution 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
.
Floor condition
Environmental conditions during transport
Ambient temperature during transport and storage
Ambient humidity
Vibration
Max. drop height
Max. shock
-20 to 75
°
C (-4 to 122
°
F)
5-95%
≤
15.8 m/s
2
0.3 m (11.8 in)
≤
98 m/s
2
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Operator’s Manual · Version 2.0
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8 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)
Example computer rack
Data storage capacity
Sample data (routine/STAT/QC)
Reaction process data
Calibration data
12 000 samples (including reruns)
12 000 tests
15 000 tests
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.
All data processing equipment connected to the system must comply with the relevant standards of IEC, UL and CSA.
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8 Specifications
Core unit cobas ® 8000 modular analyzer series
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.
e For more information, see:
System interface on page A-148
Sample containers on page A-152
The following specifications apply to the rack sampler unit of the core unit.
Rack transfer
Rack loader area
Rack unloader area
Rerun buffer
Sample rack
Rack identification
STAT samples
200 racks/h
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.
port
Roche standard rack
Identified by barcodes
Placed on a red STAT rack and placed into the STAT input
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cobas ® 8000 modular analyzer series 8 Specifications
Core unit
Barcode types
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
CAUTION
Incorrect results due to undetected reading errors
Barcode reading errors could potentially go undetected when a check digit is not used.
o Use only barcodes with check digits. o Use only barcode labels of a good printout quality.
o 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
Code 39 3-22 digits + 1 digit (with check digit)
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, -, /, ., $, :, +
(a)
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 Modulus 43
ITF Modulus 10/3 weight
(a) 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
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Core unit
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
CAUTION
63 mm
Barcode scan range
20 mm
Figure A-100 Scan range of sample barcode reader
Incorrect results due to misplaced barcode label
Barcode reading errors could potentially go undetected when a label is attached wrongly.
o Observe the designated scan range. Keep at least 5 mm distance between the label and the top of the sample tube.
o Do not use a wet label or a label with any writing on it.
o Attach the label upright to the sample tube (max. 5 ° inclination). Do not overlap labels.
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cobas ® 8000 modular analyzer series 8 Specifications
Core unit
Sample containers
Maximum fill height
Container Diameter × length
Primary sample tube 16 mm
×
100 mm
Primary sample tube 16 mm
×
75 mm
Primary sample tube 13 mm
×
100 mm
13 mm
×
75 mm
Hitachi standard cup
Hitachi micro cup
(a)
Comment Dead volume
Use for cup on tube 1000
μ
L
Use for cup on tube 1000
μ
L
2.5 mL
1.5 mL
500
μ
L
500
μ
L
100
μ
L
50
μ
L
Not to be used on e 602 modules!
Non-standard tube 11-16 mm
×
63-102 mm
False bottom tube 13-16 mm
×
63-102 mm 3 different types are definable
Table A-7 Sample containers
(a) If you use microcups, you have to select microcups on the Test Selection submenu as Sample Cup. Only in this case the dead volume for Hitachi micro cups is valid.
Sample cups (both standard and micro cups) can be inserted into 16-millimeter sample tubes (cup on tube) or they can be used without tubes.
e
For more information, see Sample containers on page A-65.
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 A-101 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.
o Avoid overfilling sample tubes and cups.
o Leave approximately 10 mm clearance between the liquid and the top of the tube or cup.
o If sample is spilled on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
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A-152 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Sample racks
8 Specifications
Core unit
Rack type Rack color Display in software
Routine rack
STAT rack
Rerun rack
(a)
Gray
Red
Pink
00001-03999
S00001-S00999
R00001-R00999
Calibrator rack
QC rack
Wash rack
Table A-8
Black
White
Green
Rack types
C00001-C00999
Q00001-Q00999
W00999
(a) Rerun racks are used for manual reruns in non-barcode mode only.
Label on rack
001-3999
S001-S999
R001-R999
C001-C999
Q001-Q999
W999
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cobas ® 8000 modular analyzer series 8 Specifications cobas ISE module
cobas ISE module
Applications
Detection system
Throughput
Sample pipetting volume
Reagent pipetting volume
Measuring range (serum)
Measuring range (urine)
Measuring temperature
Cycle time
Detection of sample clogging
Liquid level sensor
Mixing method
Na
+
, K
+
, Cl
-
in serum or urine
Ion-selective electrode system
One unit installed: up to 300 samples/h
Two units installed: up to 600 samples/h
15
μ
L (normal sample volume)
10
μ
L (decreased sample volume for urine)
Dil 450
μ
L/sample (dilution to 1/31)
ISE IS 500
μ
L/sample (measurements in succession)
1050
μ
L/sample (single measurement)
KCl 130
μ
L/sample
Na
+
K
+
80-180 mmol/L
1.5-10.0 mmol/L
Cl
-
Na
+
60-140 mmol/L
10-250 mmol/L
K
+
Cl
-
1-100 mmol/L
10-250 mmol/L
35
° ±
2
°
C
2
×
12 s
Pressure sensitive clot detection system
Capacitance sensing technology
Non-contact ultrasonic mixing
Roche Diagnostics
A-154 Operator’s Manual · Version 2.0
8 Specifications cobas c 701 module cobas ® 8000 modular analyzer series
cobas c 701 module
The following specifications apply to the c 701 module.
e For more information, see:
Dead volumes (c 701) on page A-155
Photometric measuring system on page A-156
Reaction system
Applications
Number of reagent packs
Throughput
Reaction volume
Reaction temperature
Reaction disk
Reaction cells
Reaction times
Pipetting cycle
Mixing method o 200 photometric applications can be registered o 8 calculated tests o 3 serum indices
Up to 70
2000 tests/h
100-250
μ
L
37 ± 0.1
° C circulating incubator bath
Turntable system with 406 reaction cells
14 segments of 29 reaction cells each (semi-disposable cuvettes for photometry)
3-10 min, in 1-minute steps
1.8 s
Non-contact ultrasonic mixing
Processing capacity varies depending on measuring conditions, test selection and system configuration.
Sampling system
Sample types
Sample pipetting volume
Detection of sample clogging
Liquid level sensor
Serum/plasma, urine, CSF, supernatant, oral fluid and other
1.5-35
μ
L, in 0.1
μ
L increments
Pressure sensitive clot detection system
Capacitance sensing technology
Dead volumes ( c 701) Sample container
Hitachi standard cup directly on the sample rack
Hitachi standard cup on top of a 16 mm diameter tube
Primary sample tube, 13 mm diameter
Primary sample tube, 16 mm diameter
Table A-9 Sample container dead volumes for c 701
Dead volume
100
μ
L
100 μ L
500
μ
L
1000 μ L
Roche Diagnostics
Operator’s Manual · Version 2.0
A-155
cobas ® 8000 modular analyzer series 8 Specifications cobas c 701 module
Reagent system
Reagent identification
Reagent pipetting volume
Reagent pipetting timing
Reagent storage
Reagent configurations
Reagent cooling
Remaining reagent volume control
Automatic identification
5-180
μ
L, in 1
μ
L increments (5-19
μ
L: + 20
μ
L water)
3 timings possible (R1: 3.6 s; R2: 113.4 s; R3: 307.8 s)
Refrigerated compartment for up to 70 reagent packs
3 different configurations available with up to 2 reagent containers per cobas c pack large
5-15
°
C
Reagent registration by LLD and automatic test countdown with each pipetting
Photometric measuring system
Light source
Photometer
Wavelengths
Optical path length
Optical range
Linearity
Optical mode
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
A-156 Operator’s Manual · Version 2.0
8 Specifications cobas c 502 module cobas ® 8000 modular analyzer series
cobas c 502 module
The following specifications apply to the c 502 module.
e For more information, see:
Photometric measuring system on page A-158
Reaction system
Applications
Number of simultaneous tests
Throughput
Reaction volume
Reaction temperature
Reaction disk
Reaction cells
Reaction times
Pipetting cycle
System start-up time
Mixing method
Up to 200 applications: o 200 photometric applications can be registered, max. 86 applications can be assigned per module o 8 calculated tests o 3 serum indices
Up to 60
Up to 600 tests/h
100-250
μ
L
37
±
0.1
°
C circulating incubator bath
Turntable system with 160 reaction cells
8 segments of 20 reaction cells each (semi-disposable cuvettes for photometry)
3-10 min, in 1-minute steps
6 s
12 min (power on to standby)
Non-contact ultrasonic mixing
Processing capacity varies depending on measuring conditions, test selection and system configuration Sample types Serum/Plasma, urine, CSF, supernatant, whole blood.
Roche Diagnostics
Operator’s Manual · Version 2.0
A-157
8 Specifications cobas c 502 module
Sampling system
cobas ® 8000 modular analyzer series
Sample types
Sample pipetting volume
Detection of sample clogging
Liquid level sensor
Serum/Plasma, urine, CSF, supernatant, whole blood, oral fluid and others
1.5-35
μ
L, in 0.1
μ
L increments
Pressure sensitive clot detection system
Capacitance sensing technology
Dead volumes
Sample container
Hitachi standard cup directly on the sample rack
Hitachi standard cup on top of a 16 mm diameter tube
Primary sample tube, 13 mm diameter
Primary sample tube, 16 mm diameter
Table A-10 Sample container dead volumes for c 502
Dead volume
100
μ
L
100
μ
L
500
μ
L
1000
μ
L
Reagent system
Reagent identification
Reagent pipetting volume
Reagent pipetting timing
Reagent storage
Reagent bottles
Automatic identification, automatic reagent pack loading/unloading
5-180
μ
L, in 1
μ
L increments (5-19
μ
L: +20
μ
L water)
3 timings possible (R1: 3.2 s; R2: 90.2 s; R3: 300.2 s)
Refrigerated compartment for up to 60 reagent packs
4 different configurations available with up to 3 reagent containers per cobas c pack.
o Container: 20 mL, 40 mL, or 60 mL o Configuration: 20/40/20 ml, 40/40 ml, or 60/20 ml
5-12
°
C
Automatic test countdown with each pipetting
Reagent cooling
Remaining reagent volume control
Capacity of cassette disposal 10 reagent packs
Photometric measuring system
Light source
Photometer
Wavelengths
Optical path length
Optical range
Linearity
Optical mode
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;
±
2 nm
5.6 mm
0.0-3.3 absorbance
Up to 2.5 absorbance
Monochromatic and bichromatic
Roche Diagnostics
A-158 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
cobas e 602 module
The following specifications apply to the e 602 module: e For more information, see:
ECL measuring system on page A-160
8 Specifications cobas e 602 module
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
±
0.3
°
C (98.6
±
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
Dead volumes ( e 602) Sample container
Hitachi standard cup directly on the sample rack
Hitachi standard cup on top of a 16 mm diameter tube
Primary sample tube, 13 mm diameter
Primary sample tube, 16 mm diameter
Calibrator/control vial
Table A-11 Sample container dead volumes for e 602
Roche Diagnostics
Operator’s Manual · Version 2.0
Dead volume
100
μ
L
100
μ
L
500
μ
L
1000
μ
L
200
μ
L
A-159
cobas ® 8000 modular analyzer series 8 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)
Liquid waste handling
Solid waste handling
ECL measuring system
Measuring method
Measuring cells
Calibration mode
Test protocols
Auxiliary reagents temperature
Detection unit temperature
Pre-wash station temperature
20
±
3
°
C (68 ± 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
Liquid level detection (LLD)
2-dimensional barcode (PDF417)
Available
Reagents are automatically opened and closed
Available
Optional: Two waste containers (20 L)
Two waste boxes for used AssayTips and AssayCups
(max. 672 per box) and the magazine waste section for magazine waste (max. 12 magazines).
Integral measuring of an electrochemiluminescence
(ECL) signal
2 individually calibrated ECL measuring cells two-point calibration
26 test methods
28
° ±
2
°
C (82.4
±
4
°
F)
28
° ±
0.3
°
C (82.4
±
0.5
°
F)
20
° ±
1
°
C (68
±
2
°
F)
This is the last page of Part A.
Roche Diagnostics
A-160 Operator’s Manual · Version 2.0
Operation instrument
B
9 Safety information for operation . . . . . . . . . . . . . . . . . . . . . . . B-3
10 Software basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9
11 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-45
16 Extended operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-211
cobas ® 8000 modular analyzer series 9 Safety information for operation
Safety information for operation
Make sure that you have read and understood the chapter
. The following safety messages in particular are relevant:
Warning messages: o
Electrical shock from electronic equipment on page A-8
o
Infection from samples and associated materials on page A-9
o
Infection and injury due to sharp objects on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
Caution messages: o
Personal injury due to contact with moving parts on page A-11
o
Incorrect results due to incorrect reagent volume on page A-11
o
Incorrect results and interruption of analysis due to contaminated samples on page A-11
o
Incorrect results due to evaporation of samples or reagents on page A-12
o
Incorrect results due to carryover on page A-12
o
Fatigue due to long hours of operation on page A-14
o
Observe the system safety labels illustrated and described starting on page A-16.
WARNING
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.
a Safety messages (overall system)
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in personal injury and infection.
o Whenever possible, keep the covers of the analytical modules closed.
o Do not open any cover while the module is operating.
o Do not touch any parts of the instrument other than those specified.
o Observe all instructions given in this manual very carefully.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
the following: T-1, T-10, T-12, T-14, T-17, F-1, F-2, F-9, F-13, R-1, R-2, R-5.
Roche Diagnostics
Operator’s Manual · Version 2.0
B-3
9 Safety information for operation
CAUTION
CAUTION
Roche Diagnostics
B-4 cobas ® 8000 modular analyzer series
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.
o Before starting operation or maintenance, be sure to close and lock all covers.
Operation will not start if an interlock cover is open.
o Do not open interlock covers during operation or maintenance.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
e See:
Interlock function on page D-13.
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.
o Only load or unload racks when the green status LEDs on the rack loader are on.
o Do not insert your fingers or any objects into the rack loader/unloader while the instrument is operating.
o Keep all covers closed and in place while the instrument is operating.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
Incorrect results due to sample contamination
If foreign material falls inside the rack loader, samples may get contaminated.
o Keep the cover of the rack loader closed while the instrument is operating.
o Do not place anything on the cover of the rack loader.
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.
o Do not use reagents, diluents or detergents that have exceeded their expiration dates.
o 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 o When operating in non-barcode mode (available for STAT samples only), make sure to load the samples according to the Requisition List provided by the instrument.
o Avoid empty positions within the racks. Do not place nonregistered samples in any empty rack position.
o When manually assigning positions, ensure the position is not already assigned.
o Do not insert any gray rack into the STAT port when operating in non-barcode mode because the predefined sequence of samples may be disrupted by the STAT-port inserted routine rack.
Incorrect results due to incorrect definition of sample volume
If you use standard and micro sample cups, the correct sample volume has to be selected when ordering samples manually from the Test Selection submenu or via LIS.
If a wrong sample volume is selected, the sample pipetting will be inaccurate and thus lead to inaccurate measurement results.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 9 Safety information for operation
NOTICE
CAUTION
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.
o Always keep a firm grip on the handle and do not let go when opening or closing a top cover.
o 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.
Back up your data (measurement results and system parameters) at regular intervals.
e See
Archiving data and performing data backups on page B-231.
a Safety messages (cobas ISE module)
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.
o Only perform measurement if the covers of the ISE module are installed.
o Before opening or closing the cover of the ISE measuring units, make sure the instrument is in Standby or powered off.
o Do not touch components of the ISE module during measurement.
Roche Diagnostics
Operator’s Manual · Version 2.0
B-5
9 Safety information for operation cobas ® 8000 modular analyzer series
WARNING
CAUTION
NOTICE a Safety messages (cobas c 701 and c 502 modules)
Infection due to contact with splashes of reaction solution or by inhaling reaction solution aerosol from the ultrasonic mixer
Keep all covers closed and in place while the instrument is operating.
Incorrect results due to missing covers
Measuring with open top cover or reagent disk cover may lead to abnormal temperature control, which may cause incorrect results. o 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.
o Check the instrument performance by measuring QCs.
o 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.
o Make sure that the volume of reaction solution stays in the range of 100 to 250 especially when loading a new application onto the instrument.
Damage to the instrument (c 502 only)
μ L, o For information on analytical parameters of each reagent, contact its manufacturer.
Excessive weight on the foldable table of the c 502 module may lead to damage.
o Do not place anything other than reagent packs upon the table.
o Maximum load of the table is 2 kg.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
Roche Diagnostics
B-6 Operator’s Manual · Version 2.0
s cobas ® 8000 modular analyzer series 9 Safety information for operation
CAUTION
NOTICE a Safety messages (cobas e 602 modules)
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.
o Only perform measurement when the covers are closed.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
Incorrect results due to foam on the surface of the ProCell/CleanCell reservoirs
Before start of analysis, check that no foam has been accumulated on the surface of the e 602 ProCell/CleanCell reservoirs.
o Clean the ProCell/CleanCell reservoirs if foam has been accumulated.
e See
Cleaning ProCell/CleanCell nozzles and replace reservoirs on page D-195 .
Damage to the instrument
Excessive weight on the magazine drawer of the e 602 module may lead to damage.
o 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.
o Pull out the magazine drawer gently and do not lean on the magazine drawer.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
Roche Diagnostics
Operator’s Manual · Version 2.0
B-7
9 Safety information for operation cobas ® 8000 modular analyzer series
Roche Diagnostics
B-8 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Software basics
10 Software basics
Table of contents
This chapter is an introduction to the basic operational procedures for the cobas 8000 instrument.
Roche Diagnostics
Operator’s Manual · Version 2.0
In this chapter Chapter
10
B-9
10 Software basics
Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
B-10 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 10 Software basics
Graphical user interface
Graphical user interface
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
B
A
Presented below is an example of the Overview menu, visualizing the different areas.
C
D
Roche Diagnostics
Operator’s Manual · Version 2.0
A Menu and data
B Status line
Figure B-1
C
D
Help buttons
Global buttons
Areas with different functions on the graphical user interface
B-11
10 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 first, if you are
not familiar with these concepts.
e See
Software design and functionality on page B-33
The software can be operated via touch screen, mouse or keyboard.
e For information about operation with the keyboard, see
Guidance prompt
Figure B-2 Guidance Prompt area
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 information prompt is specific to the location of the cursor.
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.
o The global buttons allow control of common system functions, for example starting and stopping the system. e See
Workflow for daily operation on page B-15
See
The help system of the instrument on page B-24
Roche Diagnostics
B-12 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Status line
10 Software basics
Graphical user interface
Figure B-3 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
A B
A Direct Help button (tooltip)
B F1 Help button
Figure B-4 Direct help and F1 Help buttons
The direct help 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 F1 Help button will open a new dialogue window that displays the content of this
Operator’s Manual as an electronic document. To simplify the use of this electronic manual, topics are connected via hyperlinks for more information.
e For information about using the help buttons, see
The help system of the instrument on page B-24.
Roche Diagnostics
Operator’s Manual · Version 2.0
B-13
10 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 rack processing.
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 Requisition List , Calibration Load List , QC
Load List , or maintenance reports.
To select Start condition settings and to start analysis.
Figure B-5 The global buttons
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.
e For information about operation with the keyboard, see
Roche Diagnostics
B-14 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 10 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.
Work Flow Guide
Figure B-6 cobas 8000 main menu Overview of its individual configuration.
This menu provides access and control for all modules of the instrument irrespective
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.
Roche Diagnostics
Operator’s Manual · Version 2.0
Follow this working direction
Figure B-7 Using the workflow guide as guidance
Red and yellow 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.
B-15
10 Software basics
Graphical user interface cobas ® 8000 modular analyzer series
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.
Figure B-8 Individual tabs allow exploring the cobas 8000 system
Submenus
Main menus will guide you into main subject areas. Every main menu is further more structured into submenus .
e
For a submenu overview, see:
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 the corresponding Reagent Overview window.
Roche Diagnostics
B-16
Figure B-9 Symbol buttons in the Module Overview area
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 10 Software basics
Graphical user interface
Menus overview
Workplace
Test Selection
Data Review
Main Menus and related submenus
Reagent
Presented below is an overall view of all main menus and its related submenus that are available:
Calibration QC Utility Overview
Setting
Status
Status
Calibrators
Install
Status
Run Status
Controls
Install
System
Maintenance
Application
Special Wash
System
Configuration
Always start from the Overview menu
Rack Loader/
Unloader
ISE c701 c502 e6-1, e6-2
Module Overview
Figure B-10
Sample Tracking
Reagent Overview –
ISE
Reagent Overview – c 701
Reagent Overview – c 502
Reagent Overview – e 602
Accessing data and control in detail
Standard software components like buttons, menu tabs and windows are used each menu screen. If you are not familiar with these components, we recommend that you
read the chapter Software design and functionality first.
e See
Software design and functionality on page B-33
Roche Diagnostics
Operator’s Manual · Version 2.0
B-17
10 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 two submenus: o Test Selection o
Data Review
The Test Selection submenu is used to perform the following tasks: 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.
The Data Review submenu is used to perform one of the following: o
To review, backup, edit, delete and/or send and print data (data and results are interchangeably used throughout this document)
Roche Diagnostics
B-18
Figure B-11 Workplace menu e For more information, see:
Test Selection submenu on page B-73
Data Review submenu on page B-81
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Reagent
The Reagent menu offers two submenus: o Setting o
Status
These submenus are used to: o view detailed reagent information
10 Software basics
Graphical user interface
Figure B-12 Reagent menu e For more information, see:
Roche Diagnostics
Operator’s Manual · Version 2.0
B-19
10 Software basics
Graphical user interface
Calibration cobas ® 8000 modular analyzer series
The Calibration menu offers three submenus: o Status o
Calibrators o Install
These submenus are used to perform the following tasks:
The calibration method for the start-up calibration or for an calibration can be determined here.
If a calibration in between is necessary, it can be requested by test and calibration type.
Roche Diagnostics
B-20
Figure B-13 Calibration menu
These functions are available at calibration:
Calibration Status o To view recommended calibrations 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 e For detailed information, see:
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
QC
Calibration Install o To download a new calibrator from cobas link o
To download a new lot of calibrator to the system o To manually add a new calibrator o
To manually edit calibrator setpoints o To delete a calibrator from the system e For detailed information, see:
Calibration - Calibrators o
To assign a rack and position to a calibrator e For detailed information, see:
Calibrators submenu on page B-166
The QC menu offers four submenus: o Status o
Run Status o Controls o
Install
These submenus are used to perform the following tasks:
10 Software basics
Graphical user interface
Figure B-14 QC menu
QC 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 e For more information, see:
Roche Diagnostics
Operator’s Manual · Version 2.0
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10 Software basics
Graphical user interface cobas ® 8000 modular analyzer series
QC Run Status o To view all processed controls evaluated against their reference ranges e For more information, see:
Run Status submenu on page B-205
QC Controls o
To assign a rack and position to a control e For more information, see:
Controls submenu on page B-206
QC Install o To download a new Roche control from cobas link o
To download a new lot number of an existing Roche control from cobas link o To manually add a new control or new lot number to the system o
To activate tests for controls o To delete a control from the system e For more information, see:
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Utility
10 Software basics
Graphical user interface
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.
Figure B-15 Utility menu e For more information, see:
Performing maintenance items on page D-18
Application submenu on page B-256
Special Wash submenu on page B-270
System Configuration submenu on page B-280
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10 Software basics
The help system of the instrument
The help system of the instrument
cobas ® 8000 modular analyzer series
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 and o
Direct Help (tooltips).
A B
A Direct Help button
B F1 Help button
Figure B-16 Online help buttons e For more information on F1 Help, see:
Searching for information in the help system on page B-28
Printing F1 Help topics on page B-32.
e For more information on Direct Help, see:
About Direct Help on page B-32.
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The help system of the instrument
About F1 Help
The F1 Help window
This help feature displays information related to the current window . a 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 <F1> on the keyboard.
The help window opens displaying the desired help information. Hypertext links guide you to additional information and procedures related to this window.
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.
The F1 Help window comprises three main areas: o
o
o
A
B
C
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A Button bar
B Navigation pane
Figure B-17
C Topic area
Area of the F1 Help window
(example screenshot from the English version)
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10 Software basics
The help system of the instrument
Button bar cobas ® 8000 modular analyzer series
The buttons on the top of the help window provide the following functions:
Hide / Show
Previous / Next
Back / Forward
Refresh
Allows you to show or hide the navigation pane. This feature provides more space in the topics pane, 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 disabled. The record of topics viewed is deleted each time you exit the F1 Help.
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 ).
Navigation pane
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
F1 Help
tab uses book and page symbols to display the contents of the
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.
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The help system of the instrument cobas ® 8000 modular analyzer series
A
B
Topic area
A Button bar
B Navigation pane
Figure B-18
C Topic area
Areas of the F1 Help window (example screenshot from the English version) e For information on the Contents , Index , Search , and Favorites tabs, see: topic.
Searching for information in the help system on page B-28
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
Related topics All subtopics to the current topic are listed at the end of each topic.
Alternatively, you can navigate to subtopics using the Next button or using the
Contents tab.
Links Jumps to associated topics are indicated by blue text. When you point to a link, the mouse pointer changes to a hand shape. e For information on the symbols used in the topic area, see:
Conventions used in this document on page 12.
C
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10 Software basics
The help system of the instrument cobas ® 8000 modular analyzer series
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.
a To use the Contents tab
1
Choose the Help icon in the top right corner of the screen or press <F1>.
The Help window appears displaying 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 appropriate topic .
o Use the scrollbar of the navigation pane to scroll up and down within the topics of the help system.
a To use the Index tab
1
In the F1 Help window, choose the Index tab to display the list of index entries.
2
Enter 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.
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cobas ® 8000 modular analyzer series a To use the Search tab
1 In the F1 Help window, choose the Search tab.
10 Software basics
The help system of the instrument
Figure B-19 Search tab
2 In the text box, enter 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.
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The help system of the instrument
Search options and recommendations
Recommendations for better search results
Search options
The number of search results is displayed above the result list ( Found: xx).
Problem
Too many search results
Recommendation
1. Select the Search titles only check box.
2. Deselect 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 B-1
1. Select the Match similar words check box.
2. Deselect 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
AND
OR
NEAR
NOT
Use this option to join words or phrases when both (or all) the 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.
Search previous results
Match similar words
Search titles only
Table B-2
Select this check box to limit the search results, and search through your results list from previous search.
Deselect this check box if you want to search through all of the files in the Online Help.
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.
Deselect this check box for a full-text search.
Search options
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Using favorites
10 Software basics
The help system of the instrument
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. a To add a favorite
1
In the F1 Help, search for or navigate to the desired topic.
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Figure B-20 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.
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 a number of 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 = Reagents , … ). All topics from the Workplace menu will be sorted together by the prefixed 1 in the favorite name.
a To rename a favorite
1 In the Favorites tab, select the desired favorite.
2 Right-click on the favorite name and select Rename .
3 Enter the new name and press <Enter>.
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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.
a To print a help topic
1
In the F1 Help, 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.
About Direct Help
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.
a 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.
The Direct Help can only provide short tooltips
If you require more information about an element, please press <F1> to open the
F1 Help system.
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Software design and functionality
Software design and functionality
This chapter presents some basic information about the software structure of the graphical user interface 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 range upper (or lower) line of a line
, 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.
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10 Software basics
Software design and functionality
Software elements
cobas ® 8000 modular analyzer series
The illustrations (Figure B-21 up to Figure B-33) presented below present more
detailed software functions which are necessary when working with the system.
Menu and submenu
A
B
GUI elements 01
A Menu
Figure B-21
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.
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Parameter group, list box and tab
C
B
A
10 Software basics
Software design and functionality
A Parameter group
B List box to select an item or a property
Figure B-22 GUI elements 02
C Tabs - examples
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. Figure B-22
demonstrates how to select the property of a test application such as: o
Analyze - as selected in the list box of Figure B-22
o Calib.
o
Range o Other o
Formula
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.
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10 Software basics
Software design and functionality
Dialog window and submenu area
B
A cobas ® 8000 modular analyzer series
A Example for a dialog window - this window does not appear in the application submenu and is for demonstration purposes only
B Area of a submenu - as an example
Figure B-23 GUI elements 03
Area An area describes a smaller range of the graphical user interface that offers more detailed information.
Dialog window Usually, the system uses a dialogue window to interact with the operator, for example deleting an application. Depending on an action by the operator a related window will pop up.
When all entries have been made, the operator must confirm his action by choosing
Yes, No, OK, Save or Update. Afterwards the window closes automatically.
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Buttons
10 Software basics
Software design and functionality
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 may have a so-called radio button. Choosing a radio button will activate or deactivate a function.
OK
Cancel
Yes
No
Close
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A Buttons with radio button function
B Standard button disabled
Figure B-24 Examples of buttons
C Standard buttons
The following buttons are used throughout the software. These buttons are explained below.
C
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.
B-37
A
10 Software basics
Software design and functionality
Save
Update
Excecute cobas ® 8000 modular analyzer series
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.
Lists
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).
A
B
A List
Figure B-25
B Scroll bars
Example of a list and scroll bars
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List box
10 Software basics
Software design and functionality
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
A List box
Figure B-26 Example of a list box as part of a submenu
Additionally, a list box can be contained within a list, specifying an additional parameter.
2 Point, Full or Span can be selected.
In the example below, an appropriate calibration method for an individual test, Blank,
A
A List box
Figure B-27 Example of a list box within a list
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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
Text boxes and fields
A Selected lines
Figure B-28 Example of a list with four individual lines selected
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
Figure B-29 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 deselecting check boxes or options.
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Check boxes
10 Software basics
Software design and functionality
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
Options
A Multiple check boxes
Figure B-30 Example of multiple check boxes
Confirming a check box
Data Initialization has been checked , confirm this action by choosing the OK button.
Figure B-31 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.
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Figure B-32 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.
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10 Software basics
Software design and functionality
Windows cobas ® 8000 modular analyzer series
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 B-33 Example of a dialog window, allowing the selection between
Routine and/or STAT samples being used for automatic rerun
Usually, the dialog window is closed by selecting a confirmation button.
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Shortcut keys
10 Software basics
Shortcut keys
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.
F4
F3
F11
F10
F2
Figure B-34 Global buttons and their corresponding keys
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10 Software basics
Shortcut keys cobas ® 8000 modular analyzer series
Shortcut
Menus
Description
F5 Workplace
F6 Reagent
F7 Calibration
F8 QC
F9 Utility
F12 Overview
General functions
F1 Online help
Print Print menu
Shift + Print Creates a screenshot of the current screen. The screenshot can be printed via Print > History .
Pause Displays the Logoff window.
TAB Moves the cursor to the next button or field.
Shift + TAB Moves the cursor to the previous button or field.
Enter Confirms any entry.
Shift + x Pressing <Shift> and a character key simultaneously will generate a capital letter or a special character.
Back space Deletes a character to the left of the cursor.
Space Inserts a space left of the cursor position.
Delete Deletes a character to the right of the cursor.
Caps lock Locks the letter keys into the upper case mode.
Num lock Activates the numerical keypad to enter numbers and mathematical operators such as +, -, /, *.
Cursor control
Home Places the cursor at the beginning of a list or text box.
End Places the cursor at the end of a list.
Page up Scrolls upward in a list, one page at a time.
Page down Scrolls downward in a list, one page at a time.
Use the arrow keys to move the cursor in all directions.
Table B-3 Shortcut keys
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Daily operation
11 Daily operation
Table of contents
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
.
Please refer to the Online Help for details about each software submenu.
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In this chapter Chapter
11
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11 Daily operation
Table of contents cobas ® 8000 modular analyzer series
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cobas ® 8000 modular analyzer series 11 Daily operation
Workflow overview
Workflow overview
Daily operation encompasses 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.
Daily operation
Page
o
o
o
o
o
o
Load new samples
o
o
o
Figure B-35 Example of a daily operation workflow
Configuration of the instrument
The instructions in this chapter are given assuming that all configurations are already set.
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11 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: Automatic or manual start-up
2. Visual checks after start-up
Before performing the following actions, observe these safety precautions: o
Infection and injury due to contact with instrument mechanism on page B-3
o
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
Starting the instrument
Instrument inspection
Before starting the instrument, ensure the instrument inspection was already performed
(either before start-up or after the last power off) .
e See
Instrument inspection on page B-68.
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.
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 32 Maintenance (cobas e 602 module)
.
e See:
Extended power OFF and ON procedures on page D-229.
Automatic start-up The instrument can be programmed for automatic start-up by the time switch at the front of the core unit (see:
Setting the time switch on page B-214).
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Start-up and daily checks a 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.
e
See To review the Alarm window on page B-51.
o If the Alarm
button is not flashing, go to step 2.
Figure B-36 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 (see
Visual checks after start-up on page B-50).
When initialization has been completed, the instrument goes into Standby.
Manual start-up If no automatic start-up has been set, use the following procedure to start up the instrument.
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.
a To manually start up the instrument
1 Press the green Operation Power ON button, located at the front of the core unit.
While the instrument is performing initialization (approximately 11 minutes), the
Logon window is displayed.
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 Power Up pipe is being processed
(see Visual checks after start-up on page B-50).
When initialization is completed, the instrument goes into Standby.
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11 Daily operation
Start-up and daily checks cobas ® 8000 modular analyzer series
Visual checks after start-up
During the pipe
While and after the Power On pipe or the Start Up pipe is processed, some visual checks need to be performed.
Be sure to perform these checks prior to routine operation.
Visual checks Maintenance item
[module] 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.
[ISE, c 701]
After the pipe (Standby)
Before starting analysis
Table B-4 m After 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 .
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.
[ c 701, c 502]
[ c 701, c 502]
Visual checks while and after the pipe is processed e For information about the maintenance items recommended for the pipe, see:
Recommended maintenance pipes on page D-26.
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.
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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.
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.
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Figure B-37 Alarm window a 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.
e
See Troubleshooting on page E-1.
4 Choose Close to close the Alarm window.
Order of alarms in the Alarm window
Alarms are displayed in accordance with their priority. Alarms at the same priority level are displayed in reverse chronological order with the latest one at the top.
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11 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 5 buttons are placed in the suggested sequence of pre-routine operation. The last button – Sample Tracking – is used during routine operation.
Pre routine operation
Routine operation
Button
Preventive Action
Daily Maintenance
Figure B-38 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.
Gray
Purple
Yellow
Red
Table B-5
Normal status: No action is required.
Reagent below daily requirement.
Attention: This action will be required soon .
Attention: This action is required immediately .
General meaning of the colors in the Work Flow Guide
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.
o Tests are recommended for calibration ( Calib.
Now ) if calibrations are due within the
Remaining Time set on the Calibration Status submenu.
Use of the button
Select this check box during pre-routine operation (active by default after power on) .
We recommend deselecting the
Preventive Action check box before starting routine operation.
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.
Choose this button to perform maintenance actions.
Work Flow Guide (Sheet 1 of 2) Table B-6
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cobas ® 8000 modular analyzer series 11 Daily operation
Pre-routine operation
Button
Sample Data Clear
Reagent Preparing
Calib. and QC Select
Parameter Download
Sample Tracking
Table B-6
Explanation
The button changes color when the sample database is almost full (max. 12 000 routine, STAT and control samples). Deleting sample data on the hard disk allows faster access to the data.
o Sample database almost full o Sample database is full
Use of the button
Choose this button regularly to clear the database (the instrument must be in Standby).
We recommend performing a periodic backup of data.
The button changes color to indicate the level of a reagent is low: o Reagent below daily requirement o Reagent below alarm level o Reagent empty
Choose this button to print a Reagent
Load/Unload List and to replace the required reagents.
See
Preparing reagents on page B-54.
The button changes color to yellow to indicate a calibration or QC is recommended.
Choose this button to perform calibration and QC.
See
Performing calibration and QC on page B-55.
The button changes color to indicate new parameters for applications, calibrators, controls, and special wash are available on the data manager.
Choose this button to download parameters from the data manager.
The Sample Tracking button is used to search for samples on the instrument. Sample tracking is possible during operation as long as no samples have been removed from the unloader and no new run has been started.
Work Flow Guide (Sheet 2 of 2)
For detailed information about these functions and the meaning of the colors used, please refer to the Online Help of the Overview menu.
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11 Daily operation
Pre-routine operation
Pre-routine steps
cobas ® 8000 modular analyzer series
NOTICE
We recommend performing the pre routine steps for buttons that changed color to purple, yellow or red:
1. Perform maintenance actions (now or before power off, see page B-66)
2. Clear the database and/or back up data
3. Prepare reagents (see page B-54)
4. Perform calibration and QC (see page B-55)
5. Download parameters from cobas link
A short description of the pre -
routine steps is contained in Table B-6 on page B-52.
Steps 3 and 4 are described in the following sections in detail.
Operation of the analyzer may slow down and become error-prone
If the database for patient, calibrator or QC results is overloaded, the operation of the analyzer software may slow down and become error-prone.
o It is strongly recommended to delete the contents of the database daily.
o Make sure that the results are transferred to the Host or saved on external storage media before deleting the contents of the database.
Preparing reagents
Reagent Preparing
When the Reagent Preparing button changes color, a reagent needs to be replaced.
However, this function is available only if reagent alarm levels and mandatory tests are defined.
e 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 replaced on the instrument.
a To print a Reagent Load/Unload List
1
Choose Reagent Preparing on the Overview menu.
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B-54
Figure B-39 Reagent Preparing window
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
CAUTION
11 Daily operation
Pre-routine operation
2 Choose Reagent Load/Unload List and confirm with OK .
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.
e For information on loading reagents, see:
Loading reagents (cobas ISE module) on page B-106
Loading reagents (cobas c 701 module) on page B-117
Loading reagents (cobas c 502 module) on page B-129.
Incorrect results due to expired reagents
Results obtained using expired reagents are not reliable. Do not use reagents that are expired.
7 Choose Reagent > Setting to check the expiration status of the reagents.
Performing calibration and QC
Calib. and QC Select
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. Therefore the instrument automatically recommends calibrations and QC measurements for all applications. The Calib. and QC Select button turns yellow to indicate a calibration or QC is recommended.
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11 Daily operation
Pre-routine operation cobas ® 8000 modular analyzer series
Calibration and QC workflow
The following flow chart shows the recommended workflow.
Recommended calibration and QC workflow
Calib. and QC Select
Yellow button indicates that calibration or QC are recommended.
1 Choose the marked buttons in this order.
2
Validation: o Choose Monitor button and check for data alarms.
o On QC > Run Status , check if all QC points are within confidence range or
2SD.
Load calibrators and controls
(see printed lists)
Start measurement
Validation:
Results ok?
Yes
No
Check for data alarms and perform remedies
Remedy description:
See chapter
Continue with routine operation
Figure B-40 Recommended calibration and QC workflow
Your laboratory might use calibration and QC workflows that may differ in some details
from the recommended workflow shown here (Figure B-40).
e For more detailed information on calibration and QC, see:
Calibration (overall system) on page B-155
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Pre-routine operation
Calibration and QC steps
The entire calibration and QC process comprises the following steps:
1. Request calibration and QC and print load lists
2. Load required calibrators and controls
3. Measure calibrators and controls
4. Validate calibration and QC results a To request calibration and QC and to print load lists
1 Choose Calib. and QC Select in the Work Flow Guide area.
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 Calibration 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 .
a To load required calibrators and controls
Injury due to contact with rack loader mechanism
Only load or unload racks when the green status LEDs on the rack loader are on.
CAUTION
CAUTION
Black calibrator rack
White control rack
CAUTION
Roche Diagnostics
Operator’s Manual · Version 2.0
Incorrect results due to expired calibrators or controls
Results obtained using expired calibrators or controls are not reliable.
o Do not use calibrators or controls that are expired.
o Do not mix-up calibrator containers or control containers.
o 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 calibrator and control racks onto a tray and place it into the loader.
When you perform QC after calibration, QC racks must follow directly after calibrator racks.
Calibration or QC failure o If you need to manually assign a calibrator, QC or routine sample 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.
o Do not use micro cups for calibrators and controls.
o Regularly perform QC measurements during operation to continuously monitor the instrument performance.
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11 Daily operation
Pre-routine operation cobas ® 8000 modular analyzer series a 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.
Correct temperatures are required for measurement accuracy.
3 Choose Start (global button).
4 Choose Start to start the calibration and control run.
Validating calibration and QC results
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:
Calib. and QC Select a 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, …).
3 On the QC > Run Status submenu, check if all QC points are within the confidence 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 (see Data alarms on page E-3).
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 on page B-57.
e For information on validating QC results on the data manager, please refer to Quality
Control in Part
.
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Routine operation
Preventive Action
CAUTION
CAUTION
11 Daily operation
Routine operation
Before continuing with routine operation, deselect 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:
Before performing the following actions, observe these safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Incorrect results and interruption of analysis due to contaminated samples on page A-11
o
Injury or damage to the instrument due to contact with rack transfer mechanism on page B-4
o
Incorrect results due to sample mismatch in non-barcode mode on page B-4
o
Interrupt of operation due to interlock system on page B-4
Injury due to contact with rack loader mechanism
Only load or unload racks when the green status LEDs on the rack loader 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.
o Do not use micro cups for samples to be processed on e 602 modules.
Sample preparation
When preparing samples, always ensure that the preanalytical requirements are fulfilled according to good laboratory practice and tube manufacturer recommendations.
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Routine operation
Processing samples
In this section, the workflow is described for an instrument that operates in connection with a LIS and is set to process samples in barcode mode . The test selection is usually downloaded from the LIS (host) via the data manager.
Non-barcode mode only available for STAT samples
The data manager supports the non-barcode mode only for STAT samples although this mode is visible in the instrument software.
e For information on other configurations, see Chapter
a To load routine samples
1
If you need a list of samples to be loaded (batch mode), choose Print (global button) > Workplace > Requisition List .
2
Prepare gray routine sample racks with rack numbers according to the sample types (such as Ser/Pl, Urine, CSF…).
3
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 .)
A
A Green status LEDs on – samples can be loaded or removed
Figure B-41 Loading routine samples
4
Before opening the cover of the rack loader, check the green status LEDs ( A ) are on.
5
Load rack trays with routine sample racks into the rack loader. Ensure the correct
orientation of the racks (see Figure B-41).
e For information on sample containers and their correct placement in racks, see:
Sample containers, racks and trays on page A-64.
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Routine operation a To start processing
1 Ensure that all test selections have been made on the LIS and all necessary calibrators, controls, and routine samples have been loaded.
e For test selections from the instrument software, see:
Requesting a test manually on page B-76.
2 Choose Start (global button).
Figure B-42 Start window (barcode mode)
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 this 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.
Notes on STAT samples
NOTICE
Samples loaded from the STAT (emergency) port are processed with higher priority than those from the rack loader.
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 could not be detected, which may possibly lead to instrument damage.
o Ensure the correct orientation of the rack when loading it into the STAT port.
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Routine operation cobas ® 8000 modular analyzer series
CAUTION
Figure B-43 Loading racks into the STAT port o Any type of rack can be loaded in the STAT port and will be processed before those residing in the rack loader.
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.
Incorrect results due to sample mismatch (non-barcode mode) o Do not insert any gray rack into the STAT port because the predefined sequence of samples would be disrupted by the STAT port inserted routine rack.
Notes on additional samples
Additional samples can be loaded onto the instrument at any time. Ensure the green status LEDs on the rack loader are on. Test selections for additional samples are downloaded from the LIS in real-time.
Load additional samples either at the STAT port or into the rack loader.
o
If the instrument is in Operation mode, samples are processed without any further action.
o If the instrument is not already in Operation mode, choose Start on the Start window to initiate the run.
Calibrators and controls can also be processed like other additional samples.
Notes on automatic reruns
Reruns are usually processed automatically depending on your configuration.
e For more information on automatic and manual reruns, see:
Automatic reruns on page B-222
Performing manual reruns on page B-79
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Routine operation
Sampling Stop status
After all test requests are completed, sampling stops. The instrument remains in Rack
Reception Mode 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.
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. At a set point in time, the instrument automatically sends the results to the LIS (host) via the data manager.
The results are validated on both the instrument and the data manager: o The instrument performs a technical validation; all results processed under irregular measurement conditions are indicated by data alarms.
o
The data manager and the LIS support you in performing the diagnostic validation. Data alarms are also indicated on the data manager.
a To validate 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 (see Data alarms on page E-3).
Flagged tests will be measured again for most of the data alarms if the automatic rerun function is activated (see
Rerun list on page E-63); otherwise, perform a
manual rerun.
e For more information, see:
Performing manual reruns on page B-79
Data Review submenu on page B-81
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Routine operation
Tracking samples cobas ® 8000 modular analyzer series
The Sample Tracking window provides an overview of the samples in the unloader trays. It also allows you to search for any sample on the instrument as soon as it is registered by the instrument.
o Only STAT and routine samples can be searched for in the Sample Tracking window.
o The location of a sample is indicated only when the sample tray has not been removed from the unloader and no new run has been started yet.
a To search for a specific sample
1
Choose Sample Tracking on the Overview menu.
Figure B-44 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 unloader, the sample is highlighted in the Rack
Information area and the rack is highlighted in the Rack Monitor area.
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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.
a To view recent results
1 Choose Monitor (global button).
2 Use the scrollbar or the mouse wheel to scroll the results.
a 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 .
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11 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:
2. Powering off the instrument
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 ( 3
) you can choose between three possibilities: o
) 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.
Routine operation
1 2 3 3 3
Maintenance action, recommended point in time
Maintenance action, alternative point in time
Maintenance pipe (a set of software-controlled maintenance items), automatically performed by the instrument
1 Instrument inspection
2 Power Up pipe (if configured), requires visual checks
3 Maintenance actions, not included in a pipe. Daily and other intervals.
4 Power Off pipe (if configured)
Figure B-45 Overview of maintenance during a shift
4 1
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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.
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.
e See:
Power Up Pipe function on page D-23.
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 Maintenance (cobas e 602 module).
e See:
Extended power OFF and ON procedures on page D-229.
If reagents remain on board the instrument, the power off procedure should be performed at least once a week followed immediately by a power on.
a 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.
e
See Instrument inspection on page B-68
If the time switch has been programmed, the instrument will start up automatically at the set time.
e For information on automatic start-up by timer, see:
Setting the time switch on page B-214.
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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.
Control unit
Core
All modules
ISE c 701 c 502 e 602
Table B-7
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, and placed in the correct position.
There are no racks on the rack loader/unloader, 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 (Power On Pipe function) are loaded.
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
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Workplace
Orders and results
12 Workplace
Table of contents
Roche Diagnostics
Operator’s Manual · Version 2.0
This chapter describes common tasks associated with the Workplace menu. For a detailed description of the Workplace menu, please refer to the Online Help.
In this chapter Chapter
12
Manual reruns in non-barcode mode ............................................................. B-79
Viewing the status of controls on Test Review window ..................................... B-89
B-69
12 Workplace
Table of contents cobas ® 8000 modular analyzer series
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Introduction
12 Workplace
Introduction
The cobas 8000 modular analyzer series typically operates in connection with an LIS and is set to process samples in barcode mode . The test selection is 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.
Non-barcode mode only available for STAT samples
The data manager supports the non-barcode mode only for STAT samples although this mode is visible in the instrument software.
The barcode mode is also used if non-barcoded samples were aliquoted on a MPA. In the data manager software, this mode is called MPA mode . In this case, the cobas® 8000 modular analyzer series receives the sample ID and the rack and position number together with the test request.
Orders can be processed in two different ways (see Figure B-46).
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.
Test Selection
Real Time Inquiry mode
Test Selection
Batch Request mode
Load any samples LIS sends test selection via data manager to instrument
Instrument requests test selection from LIS via data manager
Load samples
(see Requisition List)
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Operator’s Manual · Version 2.0
Start measurement Start measurement
Figure B-46 Possible sample processing workflows
Choose Overview > Data Manager to check the current test selection settings.
To activate the Test Selection Batch Request mode, disable the Test Selection
Inquiry check box on Utility > System > Data Manager Settings > Test Selection
Inquiry Settings (administrator level access required).
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12 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 STAT or routine test selections are being entered and whether the instrument is operating in barcode mode or not.
e See
Test Selection submenu on page B-73.
Workplace > Data Review submenu e
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
See
Data Review submenu on page B-81.
Table B-8 Menu overview
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Test Selection submenu
To display this submenu, choose Workplace > Test Selection .
12 Workplace
Test Selection submenu
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-47 Test Selection submenu
Use this submenu to enter test selections and sample information for a sample. The fields available for sample identification vary, depending on whether STAT or routine test selections are being entered and whether the instrument is operating in barcode mode or not.
Fields
Sample ID
Sequence No.
Rack No. / Pos.
Table B-9
Barcode mode Non-barcode mode
Routine l
–
STAT l
–
Routine l l
– – –
Test Selection submenu - fields available for sample identification
STAT l
– l e e
For information about the test selection matrix, see Test selection matrix on page B-74
For information on special operation procedures, see:
Requesting a test manually on page B-76
Entering unreadable sample barcodes on page B-78
Performing manual reruns on page B-79
For a detailed description of all elements on this submenu, please refer to the Online
Help.
B-73
12 Workplace
Test Selection submenu cobas ® 8000 modular analyzer series
S. Type Use this list box to select the sample type: o Serum/Pl: For serum or plasma.
o
Urine: For urine samples.
o CSF: Use this sample type for cerebrospinal fluids.
o
Suprnt: Use this sample type for supernatants.
o Other: This sample type is designed only for specially programmed applications.
o
Wb: Use this sample type for whole blood.
o OraFlu: Use this sample type for oral fluid.
For each test, only four sample types are available.
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 one result is available. The test can be reordered again.
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Test Selection submenu
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 can be requested, further settings are not required. The reagent is on board and registered.
Test mask: the test can be requested but not be measured until the test is manually unmasked due to one of the following causes: 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.
Reagent mask (no reagent available, the module is masked or powered off):
Test is automatically masked by the system. The reagent pack or detergent required for the respective test is either empty or not present on the instrument. The test can be requested; however, the test is performed only if new reagent is placed on the instrument.
If a diluent or other wash solutions are empty or missing (SmpCln 1, SmpCln 2, or ProbeWash), the corresponding reagent is not masked.
Calibration mask
Test is automatically masked by the system if no valid calibration is available and the test requires a calibration.
The purple bar will not be displayed on the test key if: o Auto. Masking check box for the individual test is not selected on
Utility > Application > Calib.
o Auto. Masking check box for the instrument is not selected in the
Calibration Settings area on Utility > System > QC and Calib .
Increased sample volume o Test will run with an increased sample volume set on Utility >
Application > Analyze.
Decreased sample volume o Test will run with the decreased sample volume set on Utility >
Application > Analyze.
Dilution Ratio o Test will run with a dilution. The number after the triangle indicates the ratio of the dilution (for example, 3 is 1:3).
Profile o 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.
If the reagent for a test is not on board, the corresponding test key is marked with reagent mask.
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Test Selection submenu cobas ® 8000 modular analyzer series
Requesting a test manually
Tests may be manually selected for routine and STAT samples. In non-barcode mode only STAT samples may be manually selected.
a To request a routine sample
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
Type the sample ID of the sample in the Sample ID text box.
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.
CAUTION
Manual selections remain unchanged
All manual selections such as sample type and dilution ratio remain selected until they are manually changed.
o Sample dilution is available depending on the test setting.
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 .
a To request a STAT sample
Incorrect results due to sample mismatch (non-barcode mode)
When operating in non-barcode mode: o 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.
o 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.
1
Choose Workplace > Test Selection
2
Select the sample type from the S. Type list box.
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Test Selection submenu
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 6.
4
Type the rack number of the sample in the Rack No.
text box.
5
Type the position number of the sample in the Pos.
text box.
6
Type the sample ID of the sample in the Sample ID text box.
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.
Microcups 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.
a To check and correct registered tests and to start analysis
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, type the sample ID number of the first sample in the Sample ID text box.
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. o Or correct the selected tests. 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 7.
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.
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Test Selection submenu
Entering unreadable sample barcodes
CAUTION cobas ® 8000 modular analyzer series
The Barcode Read Error window is only available in barcode mode.
Incorrect results due to sample mismatch
When registering samples with unreadable barcodes, make sure to select the correct sample. o Check if the affected sample corresponds with the right rack and position.
a To enter an unreadable sample barcode
1 Choose Workplace > Test Selection .
2 Choose Barcode Read Error .
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Figure B-48 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
Repeat steps 3 to 7 for any further samples with a barcode read error.
9
Choose OK .
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.
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cobas ® 8000 modular analyzer series 12 Workplace
Test Selection submenu
Performing manual reruns
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.
e For general information about reruns, see:
Automatic reruns on page B-222.
Manual reruns in barcode mode
In barcode mode you may request a manual rerun like a normal test request using the
Test Selection
submenu, see Requesting a test manually on page B-76.
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 only performed for STAT 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.
e For more information, see:
Requesting a test manually on page B-76
Assigning or deleting a rerun rack on page B-80.
You can change the sample volume or request a dilution for rerun.
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Test Selection submenu cobas ® 8000 modular analyzer series
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. Use the pink rerun racks for reruns in nonbarcode mode.
a To assign a rerun rack
1
Choose Workplace > Test Selection .
2
Type the sample ID of the sample in the Sample ID text box.
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 .
a To delete a rerun rack
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.
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Data Review submenu
To display this submenu, choose Workplace > Data Review .
12 Workplace
Data Review submenu
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Operator’s Manual · Version 2.0
Figure B-49 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 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 LIS, editing, searching, filtering, and deleting data individually or in batches, and backing up data.
e For information on special operation procedures, see:
Archiving patient data on page B-90
Editing or deleting sample results on page B-87
Displaying archived patient data on page B-91
For a detailed description of all elements on this submenu, please refer to the Online
Help.
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cobas ® 8000 modular analyzer series 12 Workplace
Data Review submenu
Sample selection list
The 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 . Some of essential columns are explained below.
DM This column displays whether a result has been transferred to the data manager or not.
No symbol
H (Sent to the data manager)
Sample results have not been sent to the data manager.
Sample 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).
Sample has not been pipetted yet. No symbol
# (Sharp symbol)
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).
b (Flat symbol)
A special wash of the sample probe has been performed before the sample was pipetted (ISE and /or c 701 / c 502 module).
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 701 or c 502 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.
e For more information about special washes, see:
Programming a special wash (cobas c 701 and c 502 modules) on page B-271
Programming a special wash (cobas e 602 module) on page B-277
St.
This column displays the sample status codes.
No symbol (Complete)
O (Ordered)
P (Processing)
I (Incomplete)
Sample successfully processed.
Sample has been registered.
Sample is being processed.
Samples processed, but a data alarm is present.
The Incomplete status is not applied to control samples.
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Data Review submenu
Rack No. - Pos.
This column displays the rack number and sample position within the rack for the current sample.
Examples:
50001-2:
S40023-5:
Q30002-2:
Normal/routine rack number 1 - position 2
(range from 50001 - 80999)
STAT rack number 23 - position 5
Quality control rack number 2 - position 2
Test results list
The list on the right side of the screen displays the results of the tests performed on the sample currently selected in the sample selection list.
C. E.
This column displays whether the special wash specified has been performed before pipetting.
# (Sharp symbol)
Special wash required for this test has not been performed.
Dil In this column a symbol for the volumes to be used is displayed. These 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 marked to be run with an increased sample volume.
This applies to photometric assays ( c 701 / c 502 module) only.
This symbol indicates a test is marked to be run with a decreased sample volume. This applies to photometric assays ( c 701 / c 502 module) and ISE tests only. For ISE tests, only urine samples can be run with decreased volume.
This symbol indicates a test is marked to be run with a diluted sample volume. The number displays the dilution ratio selected in the Workplace > Test Selection submenu.
o As soon as a result is available, it is displayed in this test result list 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 .
e For more information on special operation procedures, see:
Archiving patient data on page B-90
Editing or deleting sample results on page B-87
Displaying archived patient data on page B-91
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Data Review submenu cobas ® 8000 modular analyzer series
Searching for a sample in 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.
a To display the Search Sample window
1
Choose Workplace > Data Review .
2
Choose the Search button to display the Search Sample window.
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B-84
Figure B-50 Search Sample window, left: barcode mode, right: non-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 timed area.
3 To search for a sample, perform one of the following procedures: a)
To search for a sample by sample ID on page B-84
b)
To search for a sample by comment on page B-85
c)
To search for a sample by sequence number (non-barcode mode) on page B-85
a 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.
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Data Review submenu a To search for a sample by comment
1 Select the Comment-001 option in the Find area.
The title of the comment is defined on Utility > System > Comment Titles .
e See Comment Titles window on page H-301.
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.
a To search for a sample by sequence number (non-barcode mode)
1 Select the Sequence Number option in the Find area.
2 In the list below, enter all or a part of the sequence number to be searched for.
3 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.
4
Repeat step 3 to search for further samples with the same part of the sequence
number.
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Data Review submenu
Filtering data
cobas ® 8000 modular analyzer series
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.
a To define filter criteria and filter data
1
Choose Workplace > Data Review.
2
Choose Filter button to display the Filter window.
Figure B-51 Filter window
3
Select the option you want to display in the sample selection list.
e 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.
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Data Review submenu
Editing or deleting sample results
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.
a 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 .
a 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.
more information on the test results.
3
Choose Test Review to display the Test Review window. This window displays
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Figure B-52 Test Review window
4
Select the test result in the Result column. The result is activated (blue background) and highlighted white.
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12 Workplace
Data Review submenu cobas ® 8000 modular analyzer series a To edit sample data
1 Select the test result to be edited.
2 Enter the new result (the old result is overwritten) and press <Enter>. The
Updated button turns yellow.
Edited is displayed in the Alarm column and E in the St.
column.
3 Choose Update to save the changes, or Cancel to reset the entry to the original value.
a To delete test results
1 Select the test result to be deleted.
2 Choose Delete Test to delete the test after confirmation.
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Data Review submenu
Viewing the status of controls on Test Review window
The status of control data can be viewed on the Data Review submenu and the Test
Review window.
Use the following procedures to view the status of control measurement on the Test
Review window.
a To view status of control measurement on the Test Review window
1
Choose Workplace > Data Review .
2
Select the control to be viewed from the list on the left.
3
Choose Test Review to display the Test Review window. This window displays more information on the control data.
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Figure B-53 Test Review window – control
The St.
column displays the status of the control measurement.
No symbol (Complete)
O (Ordered)
P (Processing)
I (Incomplete)
M (Mask Test)
V
Control successfully processed.
Control has been registered.
Control is being processed.
Control processed, but a data alarm is present.
Test has been masked due to an abnormality during processing. Displayed only on Workplace > Data
Review > Test Review .
Control results have been sent to the data manager but not validated yet. e For more information please refer to the Online Help .
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Data Review submenu cobas ® 8000 modular analyzer series
Archiving patient data
Use this function to make backup copies of test results on a storage medium (CD or
DVD).
a 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.
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B-90
Figure B-54 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 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.
5
Insert the storage medium (for example CD, DVD) into the corresponding disk drive.
6
Choose 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.
7
Choose OK to back up the selected data.
e For more information about the different backup options, refer to the Online Help of
Backup Data window .
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Data Review submenu
Displaying archived patient data
Only data saved in binary format (*.mdf format) can be reloaded onto the instrument.
e
Archiving patient data on page B-90
Reloaded data can only be viewed on the Data Review submenu.
a To display archived patient data
1
Make sure that the computer can access the medium that contains the data (for example mass storage device or CD/DVD)
2
Choose Workplace > Data Review.
3
Select Backup View from the Data list box to display the Read Backup window.
Figure B-55 Read Backup window
4 Choose 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 .
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Data Review submenu cobas ® 8000 modular analyzer series
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Reagents
13 Reagents
Table of contents
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.
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Operator’s Manual · Version 2.0
In this chapter Chapter
13
Columns in the Reagent Setting submenu ..................................................... B-99
Reagent Overview window (cobas ISE module) ............................................... B-104
Loading auxiliary reagents (cobas ISE module) ............................................... B-109
Auxiliary reagents (cobas c 701 module) .................................................... B-114
Reagent Overview window (cobas c 701 module) ............................................ B-115
Registering reagents manually (Development Channel) .......................... B-119
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13 Reagents
Table of contents cobas ® 8000 modular analyzer series
Loading auxiliary reagents (cobas c 701 module) ............................................ B-120
Reagent packs – cobas c packs medium ...................................................... B-123
Auxiliary reagents (cobas c 502 module) .................................................... B-127
Reagent Overview window (cobas c 502 module) ............................................ B-128
Registering reagents manually (Development Channel) .......................... B-132
Loading auxiliary reagents (cobas c 502 module) ............................................ B-133
Auxiliary reagents (cobas e 602 module) .................................................... B-138
Reagent Overview window (cobas e 602 module) ............................................ B-139
Registering reagents manually (cobas e 602 module) ................................ B-143
Loading auxiliary reagents (cobas e 602 module) ............................................ B-144
Replacing ProCell and CleanCell (cobas e 602 module) ........................... B-146
Replacing consumables and emptying solid waste (cobas e 602 module) .... B-150
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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
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:
ISE c 701 c 502 e 602
Reagent container cobas c pack large cobas c pack medium size cobas e pack Containers with 2 L and 0.5 L; two reagent container sets on double
ISE units
Identification label
Types of reagent
No barcode or RFID label
ISE REF, ISE IS,
ISE DIL
RFID label
Reagent, diluent, detergent, special reagent
Barcode label
Reagent, diluent, detergent
Barcode label
Assay, diluent, pretreatment
Instrument status during reagent replacement
Loading and unloading of reagents
Registration of new reagent o o o
Standby or module masked
Manually
Reset volume
Prime
Calibrate always
Standby or module masked
Manually o Start registration o Calibrate if recommended by software
Detection of an empty reagent Yes (countdown) Yes
Automatic reagent change over
(in case of an empty reagent)
Table B-10
No, replacement required (no standby bottle).
Yes if a standby reagent pack is on board.
Commonalities and differences of the reagents on the modules
Standby or Operation Standby or module masked
Manually Automatic loader/unloader o Automatic registration o Calibrate if recommended by software o Automatic registration o Calibrate if recommended by software
Yes Yes
Yes if a standby reagent pack is on board.
Yes if a standby reagent pack is on board.
The term reagent pack is used generally to refer to cobas c packs, cobas e packs, and other reagent containers.
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Reagents (overall system)
Menu summary
cobas ® 8000 modular analyzer series
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 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 o To view information about reagent pack sets e See
Reagent > Status submenu 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) e
The Reagent > Status submenu is used to perform the following:
See
Table B-11 Reagent menu overview
Color scheme for reagent levels
The following colors are used in the Reagent submenus to indicate low reagent levels:
Color
Red
Yellow
Purple
White
Table B-12
Meaning
A reagent is empty on this module. The corresponding tests can not be performed (reagent masking) until the reagent is available.
The number of tests remaining for a reagent is less than the yellow alarm level. Levels are defined under Utility > System > Reagent Level .
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 is sufficient on this module.
Color scheme for reagents
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13 Reagents
Reagents (overall system) cobas ® 8000 modular analyzer series
Reagent types
The following abbreviations are used in the Reagent submenus:
Module
ISE c 701, 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
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/NaOH-D 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 the c 502 module
Diluent/NaCl
Hitergent (surfactant for the incubator bath) e 602 e 602 Inventory
(Reagent Status submenu)
DIL
ASSAY
D3 or SCCS
SPR
DIL or NACL
Hitergent or
HIT-D
SmpCln 1,
SmpCln 2
PRE
CleanCell (CC)
PreClean
ProCell (PC)
ProbeWash
Reagent types Table B-13
Sample probe wash solutions
(SmpCln 1 = basic wash, SmpCln 2 = acid wash
Special reagent ( c 701 only), can be used by multiple assays as additional reagent
Assay reagent pack (current or standby)
Diluent reagent pack
Pretreatment reagent pack
For details, see Auxiliary reagents (cobas e 602 module) on page B-138.
e For details on the reagents used on a particular module, see:
Reagent concept (cobas ISE module) on page B-101
Reagent concept (cobas c 701 module) on page B-110
Reagent concept (cobas c 502 module) on page B-123
Reagent concept (cobas e 602 module) on page B-136.
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13 Reagents
Reagents (overall system)
Setting submenu
cobas ® 8000 modular analyzer series
To display this submenu, choose Reagent > Setting .
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B-98
Figure B-56 Reagent Setting submenu
The Reagent > Setting submenu provides detailed information about each test reagent for each installed module. The compiled data include reagent code, lot number, expiration date (shelf life) as well as the on-board stability of the reagents (in days).
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 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
For a detailed description of all elements on this submenu, please refer to the Online
Help.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 13 Reagents
Reagents (overall system)
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 reagent registration. An asterisk ( * ) in this column indicates manually registered reagents.
Test This column displays the short test name of the reagent currently loaded in the corresponding reagent position. To indicate a low reagent level, the test names are highlighted using the color code previously described.
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 represents the purple alarm level for this test (only applicable if a purple alarm has been defined).
Remaining This column displays the number of tests remaining for a single reagent pack.
CAUTION
Exp. Date This column displays two expiration dates: The first one displays the expiration date
(shelf life) of the reagent.
The second expiration date (number in parentheses) displays the on-board stability of the reagent (in days).
The expiration date is displayed in red if the on-board stability is exceeded (indicated by a red (0) ) or if the shelf life is already expired.
Incorrect results due to expired reagents or mixing reagents
Results obtained using expired reagents are not reliable. Mixing together new reagent and residues of old reagent may also lead to incorrect results.
o Do not use reagents that have exceeded their expiration dates.
o Do not top off old reagent with new reagent. When a reagent pack is empty, replace it with a new one.
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13 Reagents
Reagents (overall system)
Status submenu
cobas ® 8000 modular analyzer series
To display this submenu, choose Reagent > Status .
B
A
C
A Test list
B R. Pack list: Reagents provided in reagent packs
C Inventory list: Auxiliary reagents and consumables provided in bottles or containers
Figure B-57 Reagent Status submenu
The Reagent > Status submenu provides data about test reagents to monitor the reagent status 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.
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B-100 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas ISE module)
Reagents (cobas ISE module)
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
Reagents for measurements
Calibrators
(b)
Quality controls
The following table compiles reference information for all ISE reagents, such as auxiliary reagents, calibrators, and controls.
Product name
ISE Internal Standard
ISE Diluent
ISE Reference Electrolyte
ISE Standard low
ISE Standard high
ISE Compensator
Precinorm U or Precinorm U plus
Precipath U or Precipath U plus
Short name (a)
ISE IS
ISE DIL
ISE REF
ISE Low
ISE High
ISE Comp.
PNU
PPU
Container type / size Code
1 container, 2 L
1 container, 2 L
1 container, 0.5 L
Sample tube or cup on calibrator rack;
Hitachi micro cups, non-standard and false bottom tubes must not be used for calibrators.
Sample tube or cup on
QC rack;
Non-standard and false bottom tubes can be used for QCs.
502
503
504
801
802
Table B-14 ISE reagents, calibrators, and QCs
(a) used in this documentation
(b) The calibration interval is 24 hours for all ISE applications. Calibrators are also called standards.
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cobas ® 8000 modular analyzer series 13 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 1/31 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 complete instrument is in Standby or if the module is masked and in Standby.
ISE reagent registration When you replace a reagent container, always use a new container and register it by resetting the remaining volume.
After replacement of any of the ISE reagent containers, a reagent prime is required.
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.
e For information on replacing ISE reagents, see:
Calibrators and controls
Loading reagents (cobas ISE module) on page B-106.
Calibrators ISE calibrators are used with or without barcodes. The following calibrators are used for two-point calibrations and full calibrations: o ISE Low [Std(1)]: water-based solution, used for two-point calibrations and for full calibrations o
ISE High [Std(2)]: water-based solution, used for two-point calibrations and for full calibrations o ISE Comp. [Std(3)]: serum-based solution, used for blank calibrations, full calibrations 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 .
e For information about calibrator position assignment, see:
Assigning calibrator positions on page B-167.
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Reagents (cobas ISE module)
Quality controls The following products are used for quality controls: o PNU o
PPU
Quality controls can be used either with or without barcodes. e See
Barcode or non-barcode mode on page B-194
Auxiliary reagents (ISE module)
The ISE module uses the following auxiliary reagents:
Product name Description Container type / size Position Short name (a)
Sample Cleaner 1
Sample Cleaner 2
Sample Cleaner 1
SmpCln 1
SmpCln 2
SmpCln 1
1 container, 68 mL
1 container, 68 mL
Sample tube or cup on green wash rack
Sampling area
ISE cleaning solution SysClean
Basic cleaning solution for the sample probe
Acid cleaning solution for the sample probe
For washing the sample probe, used by maintenance procedure
For washing the ISE flow path, used by maintenance procedure
Rack Pos. 1
Rack Pos. 2
Activator Activator For conditioning the ISE electrodes, used by Rack Pos. 3
Table B-15 ISE auxiliary reagents maintenance procedure
(a) used in this documentation and the instrument software
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 . e For information on monitoring the reagents and resetting the initial volume, see:
Loading auxiliary reagents (cobas ISE module) on page B-109.
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13 Reagents
Reagents (cobas ISE module) cobas ® 8000 modular analyzer series
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
A ISE unit 1
Figure B-58
Abbreviation
IS
DIL
REF
SmpCln 1
SmpCln 2
Table B-16
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)
B
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Reagents (cobas ISE module)
Reagent area The Reagent
area displays the remaining volume by way of bar-charts (see Figure B-
59). The first colored box below each bar-chart indicates the remaining volume of the
ISE reagent.
Two more color-coded boxes provide additional information on the statuses of calibration and QC.
IS DIL REF
A
B
C
D
R. P.
Cal.
QC
A Bar-chart for the remaining volume
B Remaining volume of the reagent pack (R.P.), see color explanations in the Contents area
C Calibration status
D QC status
Figure B-59
Help.
Reagent area (ISE module)
For a detailed description of all elements on this window, please refer to the Online
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13 Reagents
Reagents (cobas ISE module) cobas ® 8000 modular analyzer series
Loading 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 - Reference solution
B DIL-2 - Diluent
C IS-2 - Internal standard solution
Figure B-60 ISE reagents on the drawer
D REF - 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: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Incorrect results due to missing covers of the ISE module on page B-5
Incorrect results due to errors during ISE reagent replacement o Discard used reagent containers. Be sure to use a new container. Otherwise, inappropriate measurement result may occur.
o Execute Reagent Volume Reset after the replacement of a reagent container. This is required for appropriate reagent management.
o Execute Reagent Prime after the replacement of a reagent container.
o Take care to place the ISE reagent containers in the correct positions as labelled.
e For information about the onboard stability of the application, please refer to the corresponding package insert on cobas link.
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Reagents (cobas ISE module) a 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.
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.
e
See: To clean the ISE reagent aspiration filters on page D-84
CAUTION
A
A Correct
Figure B-61 Replacing the ISE reagent aspiration filters
5 Insert the tube into the new container ( A ).
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.
o Insert the aspiration tube into the container all the way until its end touches the bottom of the container. o 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.
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Reagents (cobas ISE module) cobas ® 8000 modular analyzer series a To perform a reagent prime
1 From the Overview menu, choose Reagent Preparing .
2 Choose Reagent Prime .
3 Select the ISE module.
4 In the Prime Item list box, select All (or the reagent corresponding to the replaced container).
5 Enter 20 in the Cycles text box (recommended number of priming cycles).
6 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.
7 If the module was masked, unmask it.
CAUTION a To request an ISE calibration
1 Make sure the ISE calibrators are placed on the rack loader.
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 o The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
o For ISE calibrations ensure that the calibrator is opened immediately before the calibration is performed.
e For details on the ISE calibration, see:
Requesting and cancelling calibrations manually on page B-164
Calibration (cobas ISE module) on page B-173.
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Reagents (cobas ISE module)
Loading auxiliary reagents (cobas ISE module)
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 o A detergent whose stability has expired must not be used. Otherwise, measurement may fail to achieve a correct result.
o Avoid adding a new detergent to the old one. Otherwise, measurement may fail to achieve a correct result.
a 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.
1
2
1 SmpCln 1 (basic wash)
2 SmpCln 2 (acid wash)
Figure B-62 Replacing sample probe detergents
3
Replace the required reagent container.
4
Choose Reagent > Status .
5
Select the detergent replaced in the Inventory list and choose Reagent Volume
Reset to reset the volume count.
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Reagents (cobas c 701 module)
Reagents (cobas c 701 module)
cobas ® 8000 modular analyzer series
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 c 701 module, including diluents and auxiliary reagents (such as basic and acid detergents).
The following application types are available on the c 701 module: o Serum proteins o
Therapeutic drug monitoring (TDM) o Drugs of abuse testing (DAT) o
Hormones o Cardiac applications
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
B-110
Figure B-63 cobas c pack large with position designations B and C
There are two types of reagent packs available for c 701 modules: o cobas c pack large – ready-to-use reagent pack o cobas c pack MULTI – empty reagent pack for Development Channel applications
COBAS INTEGRA cassettes cannot be used on c 701 modules.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 701 module)
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 Volume in mL (a) Volume in mL (a)
Configuration 1 90 30
Configuration 2 60 60
Table B-17 Bottle volumes of cobas c packs large
(a) 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, for 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 .
If one reagent pack of this Reagent Pack Set needs to be removed from the module, the set must be broken up via Reagent > Setting > R. Pack Set Information >
Break up .
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 on 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.
However, no special reagent settings are available for development channel applications.
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 (empty but assembled). These reagent packs are used 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 package insert on cobas link.
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Reagents (cobas c 701 module) cobas ® 8000 modular analyzer series
Development channel applications
Development channel applications can be performed on c 701 modules 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 and receives the corresponding parameters from the data manager. o If a reagent pack label is unreadable, an instrument alarm is issued. This cobas c pack cannot be used on the instrument. The identification can not be entered manually.
o In case the parameters can not be received from the data manager, an instrument alarm is issued.
Remaining volume control The remaining volume of the reagents in each cobas c pack is checked by liquid level detection during each reagent registration. During operation, the instrument counts every pipetting out of this reagent pack. Reagent registration can be performed manually when a new cobas c pack is loaded. Otherwise it will be performed automatically during preparation.
When the number of remaining tests (total number of tests available for an application on one module) is lower than a defined limit, an alarm is issued (yellow or purple alarm, according to configuration under Utility > System > Reagent
Level ). When the number of remaining tests becomes zero, an alarm is issued (red alarm) and the test is masked – unless another cobas c pack is available as a standby reagent pack.
Carryover evasion Even though all pipetter probes and reaction cells are washed and rinsed thoroughly after each use, it could be possible that traces of sample or reagent 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.
e For more information on programming special washes for c 701, see:
Reagent probe wash on page B-271
Sample probe wash on page B-275
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Reagents (cobas c 701 module)
Diluents
Reagent pack short name
NaCl
Table B-18
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 pre-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.
Make sure you have sufficient diluent on the c 701—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, there are universal calibrators and special calibrators 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 c 701 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.
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.
e For information about calibrators and quality controls for specific applications, refer to the corresponding package insert on cobas link.
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Reagents (cobas c 701 module) cobas ® 8000 modular analyzer series
Auxiliary reagents (cobas c 701 module)
The c 701 module uses the following auxiliary reagents:
Name Short name (a)
Description Container type / size Position
Cell cleaner 1
Cell cleaner 2
CellCln 1
CellCln 2
Cell wash solution I (NaOH-D), used for rinsing and cleaning of reaction cells
Cell wash solution II / acid wash, used test specific for rinsing and cleaning of reaction cells
Basic cleaning solution for sample probes
1 container, 2 L
1 container, 2 L
Sample Cleaner 1
Sample Cleaner 2
Hitergent
SmpCln 1
SmpCln 2
Hitergent
Acid cleaning solution for sample probes
Surfactant for incubator bath to prevent algae proliferation and foaming
1 container, 68 mL
1 container, 68 mL reagent pack
NaOHD NaOH-D
( D1 )
SMS ( D2 )
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 B-19 Auxiliary reagents on the c 701 module
(a) used in this documentation and the instrument software
Behind the front doors
Sample probe area
On 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 . This is also called reagent registration .
o Small 68 mL 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 (NaOH-D, SMS, Hitergent, 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 when a new cobas c pack is loaded. Otherwise it will be performed automatically during pre-operation.
e For information on monitoring the reagents and resetting the initial volume, see:
Loading auxiliary reagents (cobas c 701 module) on page B-120
e For information on monitoring cobas c packs, see:
Remaining volume control on page B-112
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Reagents (cobas c 701 module)
Reagent Overview window (cobas c 701 module)
On the Overview menu, choose the button that symbolizes the two reagent disks. The
Reagent Overview window appears for the selected c 701 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 reagent packs on the two reagent disks of this module o Inventory area: Status of the auxiliary reagents
D
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Operator’s Manual · Version 2.0
A
B
C
A Inner segment: R.P.
(reagent pack)
B Middle segment: Cal.
(calibration)
C Outer segment: QC (Quality Control)
Figure B-64
D Remaining volumes of CellCln 1/CellCln 2
E Remaining volumes of SmpCln 1/SmpCln 2
Reagent Overview window ( c 701 module)
E
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 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; i. e., 70 positions in total.
Each reagent pack position 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)
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Reagents (cobas c 701 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 clicking on a segment. Detailed information about the reagent pack (e.g., Remaining Tests , Registration Date and Calibration Date ) is
displayed next to the graphic (see Figure B-65).
Figure B-65
Help.
Detail window for a selected reagent pack
For a detailed description of all elements on this window, please refer to the Online
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Reagents (cobas c 701 module)
Loading reagents (cobas c 701 module)
Replace all required reagents and auxiliary reagents as indicated on the Reagent
Load/Unload List .
Replacing reagent packs The procedure for replacing cobas c packs comprises the following steps: o Check for empty reagents o
Remove empty cobas c packs from the reagent disks o Open new cobas c packs and place them onto the reagent disks o
Register currently loaded reagents
The cobas c packs containing diluent, Hitergent, detergents (NaOH-D and SMS) and special reagents, are loaded and registered in the same way as other cobas c packs.
Before performing the following actions, observe these safety precautions: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Incorrect results due to expired reagents or mixing reagents on page B-4
o
Incorrect results due to missing covers on page B-6
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. o Do not shake reagents. o When loading a cobas c pack onto the c 701 module, make sure neither bubbles nor foam are present inside the reagent pack.
Note: If the c 701 module detects foam on the surface of the reagent, this reagent pack will be masked. Remove this reagent pack for a short time until the foam has gone.
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.
a To replace 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.
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Reagents (cobas c 701 module) cobas ® 8000 modular analyzer series
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.
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.
A B C
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A Reagent disk A
B Reagent disk B
C Label on the cobas c pack facing to the left
Figure B-66 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 To register the currently loaded reagents, choose Reagent > Setting > Reagent
Registration .
11 Select the module and choose Execute .
During reagent registration, the instrument performs the following actions: o By reading the reagent pack label, the instrument checks the availability of the corresponding test application and receives parameters from the data manager.
o
The reagent probes perform a liquid level detection (LLD) and a foam detection for each reagent bottle. The number of remaining tests is calculated from the measured reagent level.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 701 module)
Foam detection
The reagent probes check for foam inside all newly inserted or reloaded reagent packs
(not available for cobas c packs MULTI) to ensure accurate level detection. If foam is detected, this reagent pack is masked and a yellow alarm Reagent Air Bubble of
Reagent Disk A/B is issued.
Remove this reagent pack for a short time until the foam has gone.
12
On the Reagent > Setting submenu, check that Reagent Type , Available Tests ,
Lot No., and Exp. Date are appropriate.
Notes on using cobas c packs
If reagent registration was not performed before start of measurement, it is performed automatically during preparation.
Multiple reagent packs with the same reagent
Unloading and reloading reagent packs
CAUTION 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.
o Already used cobas c packs can be unloaded and stored according to the storage conditions (see package insert).
o A used cobas c pack can be reloaded onto any of the c 701 modules within the same cobas 8000 instrument.
Incorrect results due to false or missing reagent volumes
Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument. Used reagent packs must not be loaded onto other instruments; otherwise information about reagent volume and onboard stability are missing, which may lead to incorrect results.
o Never refill a reagent pack. Discard empty reagent packs.
o Never load a used reagent pack onto another cobas 8000 instrument.
Registering reagents manually (Development Channel)
Development Channel applications must be registered manually on the c 701 module.
A description for loading Development Channel applications is available on cobas link.
Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche representative for more information.
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Operator’s Manual · Version 2.0
a To register a cobas c pack manually on a c 701 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.
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13 Reagents
Reagents (cobas c 701 module) cobas ® 8000 modular analyzer series
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 package insert).
4 Check that there is no foam inside the bottles of the cobas c pack.
5 Place the new cobas c pack 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 On the Reagent > Setting submenu, check that Reagent Type , Available Tests ,
Lot No., and Exp. Date are appropriate.
Loading auxiliary reagents (cobas c 701 module)
Replacing a container and resetting the reagent volume
CAUTION
When replacing auxiliary reagent containers (such as cell detergent or sample probe detergent containers), you must manually reset the reagent volume count.
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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.
o Do not shake the detergent containers before placing them on the instrument.
o Only reset the reagent volume count in the software after a new reagent container has been placed.
o Always replace empty reagent containers with new and full ones. Otherwise the volume cannot be correctly monitored by counting down from the initial volume.
Follow the procedures below to replace auxiliary reagent containers and reset their volume count:
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Reagents (cobas c 701 module) a 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
A CellCln 1
B CellCln 2
Figure B-67
A
Removing the detergent aspiration filters
B
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.
e
See: To clean the ISE reagent aspiration filters on page D-84
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.
o Insert the aspiration tube so that the end of the tube touches the bottom of the container. o Do not bend the aspiration tube.
6
Replace the container and close the front door.
7
Choose Reagent > Status .
8
In the Inventory list, select the replaced detergent and choose Reagent Volume
Reset to reset the volume count.
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13 Reagents
Reagents (cobas c 701 module) cobas ® 8000 modular analyzer series a 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.
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CAUTION
1 SmpCln 1 (basic wash)
2 SmpCln 2 (acid wash)
1
Figure B-68
2
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.
o Always reset the remaining volume after replacement of a sample probe cleaner.
o Do not replenish detergent bottles.
5
Choose Reagent > Status .
6
In the Inventory list, select the replaced detergent and choose Reagent Volume
Reset to reset the volume count.
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cobas ® 8000 modular analyzer series 13 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 the c 502 module: o Serum proteins o
Therapeutic drug monitoring (TDM) o Drugs of abuse testing (DAT) o
Hormones o Cardiac applications
Reagent packs – cobas c packs medium
Apart from various reagent containers for auxiliary reagents, cobas c packs are the principal reagent containers for photometric applications.
There are two/three types of reagent packs available: o cobas c pack – ready-to-use reagent pack o cobas c pack MULTI – empty reagent pack for Development Channel applications
COBAS INTEGRA cassettes cannot be used on c 502 modules.
B A C
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A Position A is not used in this example
B Bottle position B
C Bottle position C
Figure B-69 cobas c pack with position designations
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13 Reagents
Reagents (cobas c 502 module) cobas ® 8000 modular analyzer series
Configurations of cobas c packs medium
Each cobas c pack can contain up to three reagent containers. The center position is position A
(see Figure B-69). Pipettings at different timings (R1, R2, or R3) are not
restricted to any position.
Different configurations of cobas c packs are available. That is, the bottles in positions A through C may vary in size. The following table lists the volumes of different reagent bottles within different reagent packs: cobas c pack medium Position B
Volume in mL
(a)
40
Position A
Volume in mL
–
Position C
Volume in mL
40 cobas c pack configuration 1 cobas c pack configuration 2 cobas c pack configuration 3
20
60
40
–
20
20
Table B-20 Volumes of bottles in reagent packs
(a) 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 (empty but assembled). These reagent packs are used 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 package insert on cobas link.
Development channel applications
Development channel applications can be performed on c 502 modules using a cobas c pack MULTI. The reagent information, such as test name or diluent name 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. 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 cobas c pack is inserted backwards, reagents will be pipetted in the wrong order, leading to incorrect results. The instrument may also be damaged.
When inserting the reagent pack, make sure the barcode is facing the barcode reader.
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Reagents (cobas c 502 module) cobas c pack registration New cobas c packs are registered at the reagent pack preparation station after they have been loaded at the loading port.
e For information on the reagent pack preparation station and the reagent pack loading port, see:
Reagent pack management system on page A-112
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 R1 pipetter probe performs an initial volume check—also referred to as initial cassette volume check (ICVC)—for each of the containers in the cobas c pack, if this ICVC option has been selected.
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. When the number of remaining tests (total number of tests available for an application on one module) is lower than a defined limit, an alarm is issued (yellow or purple alarm, according to configuration under Utility > System > Reagent
Level ). When the number of remaining tests becomes zero, an alarm is issued (red alarm) and the test is masked—unless another cobas c pack is available on a second module.
Unloading and reloading cobas c packs e For more information on monitoring the reagent status, see:
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
Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument.
Never load a used reagent pack onto another instrument.
e For further instructions, see:
To unload cobas c packs on page B-131
Carryover evasion Even though all pipetter probes and reaction cells are washed and rinsed thoroughly after each use, it could be possible that traces of sample or reagent 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 bias the results of the latter.
e For more information on programming special washes for c 502, see:
Reagent probe wash on page B-271
Sample probe wash on page B-275
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Reagents (cobas c 502 module) cobas ® 8000 modular analyzer series
Diluents
Reagent pack short name
NaCl
A1CD2
Table B-21
Reagent pack long name
NaCl 9 %
Comment
Diluent for photometric tests
Hemolyzing Reagent
Gen.2
Diluents for photometric tests
Diluent for HbA1c whole blood test
NaCl For photometric applications, either water or a NaCl solution is used as diluent. 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.
Make sure you have sufficient diluent on the c 502—specially 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, there are universal calibrators and special calibrators available. The same universal calibrator is used for a large number of applications where as a special calibrator covers only a few or only one application.
Universal calibrators for c 502 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.
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.
e For information about calibrators and quality controls for specific applications, refer to the corresponding package insert on cobas link.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 502 module)
Auxiliary reagents (cobas c 502 module)
The c 502 module uses the following auxiliary reagents:
Product name Short name (a)
Description Container type / size Position
Cell cleaner 1
Cell cleaner 2
CellCln 1
CellCln 2
Cell wash solution I (NaOH-D), used for rinsing and cleaning of reaction cells
Cell wash solution II / acid wash, used test specific for rinsing and cleaning of reaction cells
Basic cleaning solution for sample probes
1 container, 2 L
1 container, 2 L
Sample Cleaner 1
Sample Cleaner 2
Hitergent
NaOHD
SMS
SmpCln 1
SmpCln 2
Hitergent
NaOH-D
(D1)
SMS (D2)
Acid cleaning solution for sample probes
Surfactant for incubator bath to prevent algae proliferation and foaming
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 reagent pack SCCS SCCS (D3) Special cell cleaning solution. Additive, used for reaction cell carry over evasion in long HbA1c batches.
Table B-22 Auxiliary reagents on the c 502 module
(a) used in this documentation and the instrument software
1 container, 68 mL
1 container, 68 mL
1 container
Behind the front doors
Sample probe area
Hitergent probe area
Reagent pack on reagent disk
Remaining volume control The instrument uses different methods to monitor the remaining volumes of the auxiliary reagents. The used monitoring method 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 68 mL containers (SmpCln 1, SmpCln 2 and Hitergent): 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 (NaOH-D, 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. e For information on monitoring the reagents and resetting the initial volume, see:
Loading auxiliary reagents (cobas c 502 module) on page B-133
e For information on monitoring cobas c packs, see:
Remaining volume control on page B-112
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Reagents (cobas c 502 module) cobas ® 8000 modular analyzer series
Reagent Overview window (cobas c 502 module)
On the Overview menu, choose the button that symbolizes the reagent disk. The
Reagent Overview window appears for the selected c 502 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 reagent packs on the reagent disk of this module o Inventory area: Status of the auxiliary reagents
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A
B
C
A Inner segment: R.P.
(reagent pack)
B Middle segment: Cal.
(calibration)
C Outer segment: QC (Quality Control)
D Remaining volumes of CellCln 1/CellCln 2
E Remaining volumes of SmpCln 1/SmpCln 2
F Remaining volume of Hitergent
Reagent Overview window ( c 502 module) Figure B-70
D
E
F
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.
The reagent disk is represented by two rings. The inner ring has 24 positions for reagent packs and the outer ring 36 positions; i. e., 60 positions in total.
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)
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 502 module)
Detailed information about a reagent pack
Choose a single reagent pack by clicking on a segment. Detailed information about the reagent pack (e.g., Remaining Tests , Registration Date and Calibration Date ) is
displayed next to the graphic (see Figure B-65).
Figure B-71 Detail window for a selected reagent pack
Help.
For a detailed description of all elements on this window, please refer to the Online
Loading reagents (cobas c 502 module)
Replace all required reagent packs and auxiliary reagents as indicated by the Reagent
Load List . Ensure that reagents have not exceeded their expiration date.
Before performing the following actions, observe these safety precautions: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Incorrect results due to expired reagents or mixing reagents on page B-4
o
Incorrect results due to missing covers on page B-6
Replacing auxiliary reagents e For instructions how to replace auxiliary reagents, see:
To replace a c 502 cell detergent container on page B-133
To replace a c 502 sample probe detergent container on page B-134
To replace the Hitergent container on page B-135
Replacing reagent packs The c 502 module automatically unloads empty reagent packs to the reagent pack disposal, which is located behind the left front door of the c 502 module. It is also possible to unload reagent packs manually from the Reagent > Setting submenu
(only possible in Standby).
e For details see
To unload cobas c packs on page B-131.
To load a new reagent pack, follow the procedure below:
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Reagents (cobas c 502 module) cobas ® 8000 modular analyzer series a 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 B-72 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. o The top cover must be closed and locked when loading cassettes.
o Leave the reagent pack table closed, except when registering reagent packs or when manually unloading reagent packs from the Reagent > Setting submenu.
o Do not insert anything other than reagent packs into the reagent pack loading port.
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.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 502 module) a To unload cobas c 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.
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.
Notes on using cobas c packs
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.
Unloading and reloading reagent packs
CAUTION o Already used cobas c packs can be unloaded and stored according to the storage conditions (see package insert).
o
A used cobas c pack can be reloaded onto any of the c 502 modules within the same cobas 8000 instrument.
Incorrect results due to false or missing reagent volumes
Reload a reagent pack only if you are sure the reagent volumes remained unchanged while the reagent pack was not on the instrument. Used reagent packs must not be loaded onto other instruments; otherwise information about reagent volume and onboard stability are missing, which may lead to incorrect results.
o Never refill a reagent pack. Discard empty reagent packs.
o Never load a used reagent pack onto another cobas 8000 instrument.
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Reagents (cobas c 502 module) cobas ® 8000 modular analyzer series
Registering reagents manually (Development Channel)
Development Channel applications must be registered manually on the c 502 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.
A description for loading Development Channel applications is available on cobas link.
Refer to the Instructions for Use for the cobas c pack MULTI. Please contact your Roche representative for more information.
a 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 package insert).
3 Check that there is no foam inside the bottles of the cobas c pack MULTI.
4 Load the cobas c pack MULTI in the same way as ready-to-use reagent packs. e
See To load a cobas c pack on page B-130
5 Choose Reagent > Setting > Manual Registration .
6 Select the Test Name and Type of the reagent and choose OK .
7 On the Reagent > Setting submenu, check that Reagent Type , Available Tests ,
Lot No., and Exp. Date are appropriate.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas c 502 module)
Loading auxiliary reagents (cobas c 502 module)
Replacing a container and resetting the reagent volume
CAUTION
When replacing auxiliary reagent containers (such as cell detergent or sample probe detergent containers), you must manually reset the reagent volume count.
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
CAUTION
Improper aspiration of detergent due to foam or air bubbles
If you shake the new detergent container before placing them on the instrument, the detergent may form foam or air bubbles.
o Do not shake the detergent containers before placing them on the instrument.
o Only reset the reagent volume count in the software after a new reagent container has been placed.
o Always replace empty reagent containers with new and full ones. Otherwise the volume cannot be correctly monitored by counting down from the initial volume.
Follow the procedures below to replace auxiliary reagent containers and reset their volume count: a To replace a c 502 cell detergent container
1
Make sure that the instrument is in Standby.
2
Open the front door of the module.
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Operator’s Manual · Version 2.0
A CellCln 1
Figure B-73
A B
B CellCln 2
Replacing the cell detergents
3 Take out the empty detergent container and remove the aspiration tube.
4 Unscrew the filter from the tube end and rinse the filter with deionized water.
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Reagents (cobas c 502 module)
CAUTION cobas ® 8000 modular analyzer series
5 Screw the filter on the tube end and place it 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.
o Insert the aspiration tube so that the end of the tube touches the bottom of the container. o Do not bend the aspiration tube.
6 Close the front door.
7 Choose Reagent > Status .
8 In the Inventory list, select the replaced detergent and choose Reagent Volume
Reset to reset the volume count.
CAUTION a 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.
1 2
1 SmpCln 1 (basic wash)
2 SmpCln 2 (acid wash)
Figure B-74 Sample probe cleaners
3
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.
o Always reset the remaining volume after replacement of a sample probe cleaner.
o Do not replenish detergent bottles.
4
Choose Reagent > Status .
5
In the Inventory list, select the replaced detergent and choose Reagent Volume
Reset to reset the volume count.
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cobas ® 8000 modular analyzer series a To replace the Hitergent container
1 Make sure that the instrument is in Standby.
2 Open the top cover of the module.
13 Reagents
Reagents (cobas c 502 module)
A
A Hitergent container
Figure B-75 Hitergent area
3
Replace the Hitergent container.
4
Choose Reagent > Status .
5
In the Inventory list, select the Hitergent and choose Reagent Volume Reset to reset the volume count.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas e 602 module)
Reagents (cobas e 602 module)
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 e 602 and the reagents that are specific for each available e 602 application. The available applications are divided into different groups: o Thyroid o
Cardiac marker o Fertility / Hormones o
Tumor marker o Anemia o
Bone marker o Infectious disease o
Torch o Diabetes o
Maternal care o Critical care o
Rheumatoid arthritis o Others
Reagent packs – cobas e packs
The principal reagent container for e 602 modules is the cobas e pack.
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Figure B-76 cobas e pack for cobas e systems
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas e 602 module)
A cobas e pack consists of three separate, capped reagent containers. The e 602 modules are capable of opening and closing these caps automatically. For each e 602 application, there is an individual cobas e pack available.
Each cobas e pack is equipped with a barcode label. The barcode label provides reagent information.
Carryover evasion 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.
e
For more information, see Programming a special wash (cobas e 602 module) on page B-277.
Diluents
For applications where dilution may be necessary, use Universal Diluent or
MultiAssay as diluent. However, some applications require specific diluents.
e For information on required diluents and recommended dilution factors, refer to the corresponding assay reagent package insert on cobas link.
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.
e For information on required calibrators and controls, refer to the corresponding assay reagent package insert on cobas link.
To obtain information about the calibrators and controls currently needed for calibration or QC, print a Calibration and QC Load List from the software.
e For information on how to print a Calibration and QC Load List , see
Performing calibration and QC on page B-55.
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Reagents (cobas e 602 module)
Auxiliary reagents (cobas e 602 module)
The e 602 module uses the following auxiliary reagents:
Product name
ProCell (PC)
CleanCell (CC)
PreClean
ProbeWash
SysClean
Table B-23
Description o Conditioning of the electrodes o Transport of the assay reaction mixture o Washing of the streptavidin-coated microbeads o Signal generation o Cleaning of tubing system and measuring cell after every measurement o Conditioning of the electrodes o To remove potentially interfering substances before signal generation—the final step of the analytical procedure.
o Required only for certain assays. Its use is indicated under
Materials required (but not provided) in the respective assay reagent package insert.
o Cleaning of the reagent probe 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 / size
Position
2 containers of 2 L Behind the middle front door
2 containers of 2 L
2 containers of
600 mL
2 containers of
70 mL
Near the reagent probe
Not on the instrument
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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
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A
B
C
A Inner segment: R.P.
(reagent pack)
B Middle segment: Cal.
(calibration)
C Outer segment: QC (Quality Control)
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) Figure B-77
F
D
E
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. The reagent disk is represented by a ring with 25 positions for reagent packs.
Each reagent pack is subdivided into three main segments. The segments of the middle and outer ring 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), for measuring channels 1 and 2 o
QC status (outer segment), for measuring channels 1 and 2
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13 Reagents
Reagents (cobas e 602 module) cobas ® 8000 modular analyzer series
Inventory area ( e 602) This area displays the amount of auxiliary reagents, magazines, magazine waste and solid waste. 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:
Example:
The number 7 indicates that
…
One full magazine
…
7 full magazines are onboard.
The place for one empty magazine
…
5 empty magazines are already onboard.
The place for cups/tips from one magazine
… the WasteLiner is nearly empty.
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 cups and tips are discarded from the current magazine and a full magazine will be lifted to the top.
o Check and update of ProbeWash solutions 1 & 2
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Reagents (cobas e 602 module)
Detailed information about a reagent pack
Choose a single reagent pack by clicking on a segment. Detailed information about the selected reagent pack (e.g., Test Name , Status and Available Tests ) is displayed inside the ring.
By double-clicking on a segment, more detailed information on this reagent is provided in a separate Detail
Figure B-78
Help.
Detail window for a selected cobas e pack
For a detailed description of all elements on this window, please refer to the Online
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Reagents (cobas e 602 module) cobas ® 8000 modular analyzer series
Loading reagents (cobas e 602 module)
Replacing cobas e packs Replace all required cobas e packs, auxiliary reagents and consumables as indicated by 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.
o Only insert cobas e packs of the correct temperature of 20 ± 3 ° C (68 ± 5.4
° F)
CAUTION a 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 red alarm.
o Never open the reagent disk cover while the module is in operation. o Before opening the cover, ensure the module has reached Standby status.
3 Lift off the reagent disk cover.
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Figure B-79 Placing cobas e packs
4
Place the required reagents in the reagent disk. Ensure that the cobas e packs are placed in the reagent disk with the correct orientation.
5
Close the cover of the reagent disk. A reagent scan is activated and the Reagent
Overview window is updated.
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Reagents (cobas e 602 module)
Registering reagents manually (cobas e 602 module)
The cobas e 602 module automatically registers all new cobas e packs. In case the automatic registration fails (if instrument is unable to read the barcode), you can manually register a cobas e pack from the Manual Registration window.
CAUTION
Incorrect results due to reagent barcode read error
If a cobas e pack is placed into a reagent disk position that was manually assigned before
(due to a barcode read error), and another barcode read error occurs, tests may be measured with a wrong reagent. This may lead to incorrect results.
o When barcode read errors occur, check reagent information thoroughly.
a To manually register a cobas e pack
1 Select an e 602 module from the Module list on the Reagent > Setting submenu.
2 Choose Manual Registration to open the Manual Registration window.
3 Type the barcode of the cobas e pack to be registered.
4 Choose OK .
same lot was scanned before.
It is only possible to manually register a cobas e pack if at least one cobas e pack of the
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Reagents (cobas e 602 module) cobas ® 8000 modular analyzer series
Loading 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.)
A
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CAUTION
B C D
A Green buttons for ProCell and CleanCell
B PreClean bottles
Figure B-80
C
D
ProCell bottles (in keyed positions)
CleanCell bottles (in keyed positions)
Green buttons near the auxiliary reagent bottles e For information on the auxiliary reagents used on e 602 modules, see:
Auxiliary reagents (cobas e 602 module) on page B-138.
Before performing the following actions, observe these safety precautions: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Incorrect results due to expired reagents or mixing reagents on page B-4
Personal injury due to contact with instrument mechanism
Contact with the syringes behind the front door may result in personal injury. o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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CAUTION
13 Reagents
Reagents (cobas e 602 module)
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.
o Only replace a bottle when the green button is flashing. o Only press a green button when the corresponding bottle was replaced.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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Reagents (cobas e 602 module)
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.
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.
e For information on the location of the reagents on the module, see:
Auxiliary reagents and cleaning solutions on page A-138.
a To replace ProCell (PC)/CleanCell (CC)
1 Open the middle door of the e 602.
Only replace a bottle if the green button is flashing.
A
B
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C
A Notch
B Aspiration tube
Figure B-81
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.
4 Remove the empty bottle, indicated by the flashing green button.
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CAUTION
NOTICE
13 Reagents
Reagents (cobas e 602 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.
o Ensure the bottle stand is present before placing the ProCell and CleanCell bottles.
o To prevent evaporation, check that each bottle is closed correctly by the slider cap.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: F-11.
5
Replace the bottle with a new one ensuring that it is firmly in place. Remove the cap.
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 > Inventory Setting .
o Choose Inventory Setting to open the Inventory Setting window.
o
Type the new lot number into the box for ProCell Position 1 or 2, respectively.
o Choose OK .
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Reagents (cobas e 602 module) cobas ® 8000 modular analyzer series
Replacing PreClean bottles
CAUTION
Two bottles of PreClean are located on the inner side of the front door of the module.
e To locate PreClean bottles, see:
Auxiliary reagents and cleaning solutions on page A-138.
Personal injury due to contact with PreClean needles
Contact with the PreClean needles may cause personal injury. o Do not put your hands into the PreClean bottle holder.
o Do not replace a bottle if the green button is not flashing.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
a 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
NOTICE
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Figure B-82 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.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: F-11 and F-16.
4 Loosen the cap to allow air into the PreClean bottle.
Only press the green button after you have replaced a bottle. Do not press the green button under any other circumstances.
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cobas ® 8000 modular analyzer series 13 Reagents
Reagents (cobas e 602 module)
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.
6 Close the middle door of the e 602.
Replacing ProbeWash bottles
Two bottles of ProbeWash are located on the analytical module near the reagent probe.
e To locate ProbeWash bottles, see:
a To replace ProbeWash
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.
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.
ProbeWash can only be replaced when the complete instrument is in Standby or if the affected module is masked and in Standby.
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Reagents (cobas e 602 module) cobas ® 8000 modular analyzer series
Replacing consumables and emptying solid waste (cobas e 602 module)
All consumables (AssayCups and AssayTips) and solid waste are located in the magazine drawer. The drawer contains consumables and solid waste.
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.
e See
Consumables components on page A-140
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 when the waste containers can be accessed.
A B
A Green status lamp
B Handle of the magazine drawer
Figure B-83 Opening the magazine drawer
Status
Off
On
Flashing
Table B-24
(magazine drawer)
Operating
DO NOT open
Drawer safe to open
(waste container)
Waste container in use
DO NOT replace it.
About to operate
DO NOT open
Standby container (empty)
DO NOT replace it.
Container full, safe to replace it.
Empty it immediately
Status indicators at the magazine drawer and waste containers
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NOTICE
13 Reagents
Reagents (cobas e 602 module)
Damage to the instrument
Excessive weight on the magazine drawer of the e 602 may lead to damage.
o 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.
o Pull out the magazine drawer gently and do not lean on the magazine drawer.
a To replace AssayCup and AssayTip magazines
1
Make sure the green status lamp (Figure B-83,
A ) at the top of the drawer is ON, then pull out the drawer all the way.
A
A Magazine waste
Figure B-84 Replacing magazines
B
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.
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Reagents (cobas e 602 module)
WARNING a 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. o 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. o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
o
Observe the system safety labels illustrated on pages A-18 to A-26 and in particular
1
Make sure the green status lamp (Figure B-83,
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.
NOTICE
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1 Green button for left WasteLiner
2 Green button for right WasteLiner
Figure B-85 Updating the inventory after replacement
Only press the green button after you have emptied a container. 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.
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.
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Calibration
14 Calibration
Table of contents
This chapter describes certain tasks associated with the Calibration menu as well as special tasks that are not usually part of the daily workflow.
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In this chapter Chapter
14
Usage recommendations for calibration ..................................................... B-155
Requesting calibrations from the Calibration > Status submenu ............ B-163
Requesting and cancelling calibrations manually ...................................... B-164
Checking information about already installed calibrators ....................... B-169
Reviewing calibration data (cobas ISE module) ............................................... B-175
Calibration concept (cobas c 701 and c 502 modules) .................................... B-177
B-153
14 Calibration
Table of contents cobas ® 8000 modular analyzer series
Reviewing calibration data (cobas c 701 and c 502 modules) ......................... B-179
Reviewing calibration data (cobas e 602 module) ............................................ B-186
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Calibration (overall system)
Calibration (overall system)
Chapter structure This chapter is separated into 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.
e
For instructions on how to perform calibrations, see Performing calibration and QC on page B-55.
e 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.
Automatic calibration Manual calibration
Recommended calibrations
Causes: o Changeover o Timeout o Calib Now o Failed o QC Violation (provided by data manager)
Start-up calibration
Cause: o Manual
Figure B-86 Automatic or manual calibration
Individual calibration
Cause: o Manual
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14 Calibration
Calibration (overall system) cobas ® 8000 modular analyzer series
Automatic calibrations
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)
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)
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 cobas c pack is inserted (reagent pack calibration).
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 SD limit. The SD limit can be defined on Utility > Application > Calib.
e For more information please refer to chapter Quality Control in Part
Recommended calibrations do not start automatically. To start the calibration, you have to request the recommended calibrations.
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Calibration (overall system)
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 )
o
individual tests for calibration are manually selected ( Individual calibration
)
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 .
e See
Selecting tests for start-up calibrations on page B-165.
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.
Validation of calibration
For individual calibrations Manual is displayed in the Cause column on e
Calibration > Status .
For more information, see
Requesting and cancelling calibrations manually on page B-164.
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
The Auto Masking function masks a reagent pack for a module or measuring cell when no valid calibration is available for this particular module or measuring cell.
This function is 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.
e See
Calibration masking on page B-264
Failed calibrations If automatic calibration masking is activated, the corresponding test with the Failed calibration data is masked. No more results are reported for this test.
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 recommendation remains for the reagent pack.
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14 Calibration
Calibration (overall system) cobas ® 8000 modular analyzer series
Barcode or non-barcode mode
On the Utility > System submenu under Barcode Settings , you can verify or change whether the system uses barcodes for calibrators or not.
When working with barcodes, calibrators are automatically identified. In case calibrators are processed without barcode or in non-barcode mode, 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 .
CAUTION
Incorrect results due to position mismatch
A misplacement of assigned calibrators (without barcode) would go undetected by the system and yield completely invalid results.
Be sure to use the specified racks and positions, for assigned calibrators (without barcode).
Do not use barcoded calibrators on a calibration rack that is assigned for non-barcoded calibrators.
e
For more information, see Calibrators submenu on page B-166.
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Menu summary
Submenu
Overview menu
14 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
Calibration Load List .
e See
Calibration > Status submenu e
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
See
Table B-25 Menu overview
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14 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 To review information about already registered calibrators o To assign calibrators to specific racks and positions e See
Calibrators submenu on page B-166.
Calibration > Install submenu
The Calibration > Install submenu is used to perform the following: e o To review information about already registered calibrators o To update calibrator information o To install new calibrators
See
Install submenu on page B-168.
Table B-25 Menu overview
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Calibration (overall system)
Overview menu
The following section explains calibration tasks associated with the Overview menu.
Choose the Overview button in the menu line, or press <F12> 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.
Calib. and QC Select a 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 B-87
3
Print the load list.
4
Prepare the calibrator(s).
Recommended calibration workflow during routine operation
Injury due to contact with rack loader mechanism
Only load or unload racks when the green status LEDs on the rack loader are on.
5 Place the calibrator rack(s) on the loader.
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.
e For a detailed description of the calibration process at the beginning of routine operation,
see Performing calibration and QC on page B-55.
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14 Calibration
Calibration (overall system)
Status submenu
cobas ® 8000 modular analyzer series
To display this submenu, choose Calibration > Status .
Color scheme
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Figure B-88 Calibration > Status submenu
This submenu shows detailed information about the calibration status of the tests on the modules selected in the Module list box. This submenu is used to select tests for start-up, timeout, changeover or manual calibrations.
e For information about particular tasks associated with this submenu, see:
Requesting and cancelling calibrations manually on page B-164
Selecting tests for start-up calibrations on page B-165
Reviewing calibration data (cobas ISE module) on page B-175
Reviewing calibration data (cobas c 701 and c 502 modules) on page B-179
Reviewing calibration data (cobas e 602 module) on page B-186
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 B-26
Column Meaning
Position The latest calibration for a reagent failed.
Or: A reagent has no valid calibration .
Cause
Cause
The instrument has recommended this test for calibration.
The test has been requested for calibration .
Color scheme for Status list
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cobas ® 8000 modular analyzer series 14 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:
Calibration > Status submenu
Calibrate recommended tests
(automatic)
Calibrate individual tests
(manual)
Calibrate start-up tests
(manual)
Select individual test
Start Up
Save
Print Calibration Load List
Request calibrations from Calibration > Status submenu Figure B-89
Calibrate recommended tests With this option you may request all tests with a yellow Cause column for calibration. 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.
e See
Requesting and cancelling calibrations manually on page B-164
Calibrate start-up tests With this option you may request a set of tests predefined as a start-up group for calibration.
e See
Selecting tests for start-up calibrations on page B-165
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14 Calibration
Calibration (overall system) cobas ® 8000 modular analyzer series
Requesting and cancelling calibrations manually a 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.
3
Select the appropriate method for a Blank, 2 Point, Full, or Span calibration in the
Method column.
CAUTION
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Figure B-90 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 2 and 3.
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 Calibration Load List and start the measurement.
e
For detailed information, see To load required calibrators and controls on page B-57.
Incorrect results due to concentrated ISE calibrators o The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
o For ISE calibrations ensure that the calibrator is opened immediately before the calibration is performed.
a 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.
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cobas ® 8000 modular analyzer series 14 Calibration
Calibration (overall system)
The entry in the Cause column for this test disappears and the Save button turns yellow.
4
To cancel further calibration requests, repeat steps 2 and 3.
5 Choose Save to save the changes.
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.
a To select tests for start-up calibration
1 Choose Calibration > Status > Start Up Setting .
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Operator’s Manual · Version 2.0
Figure B-91 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.
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14 Calibration
Calibration (overall system)
Calibrators submenu
cobas ® 8000 modular analyzer series
To display this submenu, choose Calibration > Calibrators .
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Figure B-92 Calibration > Calibrators submenu
The Calibration > Calibrators submenu is used to view information about already registered calibrators and the current rack assignment.
If you are using calibrators without a barcode, or if the instrument cannot read the barcode on the calibrator, you must assign a rack number and position to each calibrator.
e For information about particular tasks associated with this submenu, see:
Assigning calibrator positions on page B-167
Loading calibrator vials for e 602 tests on page B-185
For a detailed description of all elements on this submenu, please refer to the Online
Help.
If the Exp. Date column is highlighted in red , the corresponding calibrator has expired.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 14 Calibration
Calibration (overall system)
Assigning calibrator positions
Use the following procedure to assign a rack number and position to a calibrator if you are using calibrators without a barcode, or if the instrument cannot read the barcode on the calibrator. This can only be done if the instrument is in Standby.
Do not use barcoded calibrators on racks that have been assigned for non-barcoded calibrators. In this case, no calibration is performed. The rack is passed through to the output buffer.
a To assign calibrator positions
1 Choose Calibration > Calibrators > Rack Assign .
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Operator’s Manual · Version 2.0
Figure B-93 Calibrator Rack Assign window
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 ISE calibrators must be assigned to consecutive positions on the same rack. o
On c 701 modules, the calibrator vials can be on different racks.
o On c 502 modules, the calibrator vials can be on different racks.
o
On e 602 modules the calibrator vials must be assigned to consecutive positions on the same rack.
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 2 to 4.
6
After all necessary assignments are completed, choose OK to save the changes.
e
For more information about rack position assignment, see System submenu on page B-235.
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14 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 immunology calibrator, choose the
Immune option from the list box.
Figure B-94 Calibration > Install (Chemistry) submenu
The Calibration > Install submenu is used to review information about already registered calibrators, to update calibrator information, and to delete and install new calibrators.
e For information about particular tasks associated with this submenu, see:
Installing calibrators on page B-169
Editing concentration values on page B-171
For a detailed description of all elements on this submenu, please refer to the Online
Help.
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cobas ® 8000 modular analyzer series 14 Calibration
Calibration (overall system)
Checking information about already installed calibrators
This section describes how to check registered calibrator information.
a 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 .
Installing calibrators
Information regarding calibrator codes, lot numbers, expiration dates, and concentration values can be downloaded to the instrument using the online support function. If the information about calibrators cannot be downloaded, it is required to manually enter the relevant information into the instrument. An operator ID of supervisor level or higher is required for this operation.
e For instructions on entering calibration information manually, see
Editing concentration values on page B-171.
How to download new or update existing calibrator data from cobas link is described in the following procedure.
a To download calibrator data from cobas link
1
Make sure the instrument is in Standby.
2
Choose Calibration > Install > Download to open the Download window.
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Figure B-95 Download window
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14 Calibration
Calibration (overall system) cobas ® 8000 modular analyzer series
3 Select one of the available search conditions ( All Item , Required Item ,
Calibrator Name , Lot Number , or Release Date ). o The option Release Date refers to the date when the calibrator was released.
o
The option Required Item refers to calibrator information that was not found on the system at the time of installing calibrators into the instrument.
4
Choose Search to start searching for the selected criteria.
Figure B-96 Download window with search results
To change the order of the list select the tab (column header) to sort the list by
Calibrator Name or Release Date .
5
Select the check box of each list item to be downloaded.
6
Choose Download and confirm with Yes .
7
Choose Close to return to the Calibration > Install submenu and verify the downloaded information has been registered correctly.
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Calibration (overall system) a To add calibrators manually (without cobas link)
1 Select a blank line from the calibrator list on the Calibration > Install submenu.
2 Choose Add .
3 Type all necessary data in the Add window.
Figure B-97 Add window
4
Choose OK .
The new calibrator appears on the calibrator list.
To run tests with the newly installed calibrators, it is necessary to manually enter the calibration information for each test.
e
Editing concentration values
The concentration value of a calibrator can be edited on the Calibration > Install submenu. The instrument must be in Standby.
a 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.
4 Choose Edit . The Edit Calibrator window opens.
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Calibration (overall system) cobas ® 8000 modular analyzer series
CAUTION
Figure B-98 Edit Calibrator window (photometric)
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 701 and c 502, 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 5 through 7.
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)], always recalibrate the test with a full calibration to ensure no incorrect results are reported.
10 Calibrate the test.
11 Perform QC measurements.
No update of manually edited concentration values
In case a value has been manually edited, this value will not be updated when you download new calibrator values from cobas link.
If you want to return to the original concentration value, delete the calibrator and download it again from cobas link. Perform calibration before you resume routine operation.
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cobas ® 8000 modular analyzer series 14 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 Full calibration for Na
+
, K
+
, and Cl
- in the ISE module requires the following
3 calibrator solutions: o ISE Standard 1 (ISE Low) o
ISE Standard 2 (ISE High) o ISE Standard 3 (ISE Comp., compensator)
CAUTION
Incorrect results due to misplacement of ISE calibrators o The rack positions for barcoded calibrators are not fixed, but ISE Low must be placed before ISE High on the same rack. The ISE compensator can be placed on the same rack, or on a separate one, which then must follow the other ISE calibrator rack.
o These rules also apply to non-barcoded calibrators, but in this case the calibrator positions must additionally be set under Calibration > Calibrators > Rack Assign .
CAUTION
The slope of the calibration curve is calculated from ISE Standards 1 and 2.
ISE Comp. is designed to reduce matrix effects.
A full calibration is required every 24 hours.
Incorrect results due to concentrated ISE calibrators o The concentration of the ions increases due to evaporation, this may result in an incorrect calibration, and thus incorrect results.
o 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).
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14 Calibration
Calibration (cobas ISE module) cobas ® 8000 modular analyzer series
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.
Blank
Span
2 Point
Full
ISE tests
Only ISE Comp. [Std (3)] is used
(not recommended in US)
Not available
ISE Low [Std (1)] and ISE High [Std (2)] are used
ISE Low [Std(1)], ISE High [Std(2)], and ISE Comp. [Std (3)] are used
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)
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.
e For more information please refer to the Online Help .
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Calibration (cobas ISE module)
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 the compensator (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.
a To review calibration data
1
Choose Calibration > Status .
2
Select ISE in the Module list box.
3
Select an ISE test from the list.
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 .
4 Choose Calibration Result to display the Calibration Result window.
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Operator’s Manual · Version 2.0
Figure B-99 Calibration Result (ISE) window
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14 Calibration
Calibration (cobas ISE module) cobas ® 8000 modular analyzer series
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 Comp.) 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 Comp. is designed to reduce matrix effects. It only affects the intercept and not the slope.
a 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.
4 Select a test from the Test/Module list box on the top left of the window.
Figure B-100 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 ISE compensator [ISE Std (3)]represented by . o The right axis refers to the calculated slope values represented by .
e For a complete description of all fields and buttons, refer to the Online Help .
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cobas ® 8000 modular analyzer series 14 Calibration
Calibration (cobas c 701 and c 502 modules)
Calibration (cobas c 701 and c 502 modules)
This section contains information on the calibration concept for this module and how to review calibration results.
Calibration concept (cobas c 701 and c 502 modules)
Types of calibration curves There are six different types of calibration curves possible on a c 701 or c 502 module.
That is, there are six different types of mathematical functions possible to describe the relationship between measurement value and 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:
RCM2T1
RCM2T2
Calibration types for photometric tests
Spline
Line Graph
Linear
RCM
Table B-27
Each calibration type corresponds to one type of mathematical function. For example, Linear corresponds to a linear equation, RCM2T2 to an exponential function.
e 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
Photometric tests
Std (1)
(a)
is used
Only one calibrator out of
Std (2)-Std (6)
(b)
is used
Std (n)
(c)
and a second calibrator are used
All calibrators [Std (1)-Std (6)] are used (for nonlinear calibration types)
(a) 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.
(b) Std (2)-Std (6) refer to calibrators assigned to an application under Utility > Application > Others.
(c) Std (n) defined under Utility > Application > Calib. refer to one of the calibrator Std (1) to Std (6).
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Calibration (cobas c 701 and c 502 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 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 calibrator:
They can be used as well. In this case calibrators have to be assigned to specific racks and positions (rack assignment).
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 for the first time and all calibration quality criteria are met.
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.
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cobas ® 8000 modular analyzer series 14 Calibration
Calibration (cobas c 701 and c 502 modules)
Reviewing calibration data (cobas c 701 and c 502 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.
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.
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14 Calibration
Calibration (cobas c 701 and c 502 modules) cobas ® 8000 modular analyzer series a 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.
Figure B-101 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 .
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cobas ® 8000 modular analyzer series 14 Calibration
Calibration (cobas c 701 and c 502 modules) a 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
Operator’s Manual · Version 2.0
Figure B-102 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.
e For a complete description of all fields and buttons, refer to the Online Help .
Reaction monitor graphs of a calibration can be printed out: First, select a test from the
Calibration > Status submenu, then choose Print (global button), select Calibration
Reaction Monitor List from the list on the left, and choose Preview . Choose the History tab, select the Report, and choose Print Out .
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14 Calibration
Calibration (cobas c 701 and c 502 modules) cobas ® 8000 modular analyzer series a 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 .
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B-182
Figure B-103 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 .
o The right axis refers to the Std (2)-(6) calibrator represented by .
e 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. First, select a test from the Calibration > Status submenu, then choose Print (global button), select Calibration Trace from the list on the left, and choose Preview . Choose the History tab, select the report, and choose
Print Out .
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cobas ® 8000 modular analyzer series 14 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 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 a working curve.
RD Development
RD Production
Customer
Figure B-104 Calibration concept e 602
Calibration rules o
Calibration is best done as a part of the daily preroutine operation. However, it can be done at any time during operation as well.
o Elecsys test-specific calibrators are used. Calibrator data are downloaded via cobas link or data manager.
o
Calibrations are carried out in duplicate.
o Calibrations for both channels are automatically carried out from the same calibrator set if both 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 package insert. Carefully mix, avoiding the buildup of froth. Transfer the dissolved calibrator to the empty, labeled CalSet vials using the additional vials and labels provided.
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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 package insert information.
Positioning of calibrators Calibrators are placed in calibrator racks (black racks).
o Calibrator vials of the same set are to 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.
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.
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 channel is calibrated separately.
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.
Expired cobas e packs (reagent or diluent) can only generate a cobas e pack calibration.
e For more information about Lot and cobas e pack calibrations for e 602, refer to the
COBI CD.
Calibration quality criteria
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B-184
Calibration measurements are automatically checked against various quality criteria.
The assessment is different for qualitative and quantitative assays. The following table shows which criteria are used for quantitative assays and which are used 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 .
Quantitative assays
Missing values
Monotony of curve
Minimum signal
Calibration factor
Minimum difference
Qualitative assays
Missing values
Slope
Minimum signal
Maximum signal
Minimum acceptable difference
Deviation of duplicate measurement
System error
Table B-28
Deviation of duplicate measurement
System error
Quality criteria for quantitative and qualitative assays e For explanation of these calibration quality criteria for e 602, refer to the COBI CD .
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 14 Calibration
Calibration (cobas e 602 module)
Loading calibrator vials for e 602 tests
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.
o Before placing calibrators and controls on the loader, 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.
a To load calibrator vials
1
Place both calibration vials of a CalSet in a black calibrator rack according to the figure below.
Figure B-105 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 loader.
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14 Calibration
Calibration (cobas e 602 module) cobas ® 8000 modular analyzer series
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.
a 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.
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Figure B-106 Calibration Result (Immune) window
This window displays information relating to the calibration currently used for the selected heterogeneous immunology test (signal levels, calibration criteria).
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 14 Calibration
Calibration (cobas e 602 module) a 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.
Figure B-107 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:
The left axis refers to the Std (min) calibrator, represented by .
The right axis refers to the Std (max) calibrator, represented by .
e For a complete description of all fields and buttons, refer to the Online Help .
The calibration trace can be printed. First, select a test from the Calibration > Status submenu, then choose Print (global button), select Calibration Trace from the list on the left, and choose Preview . Choose the History tab, select the report, and choose
Print Out .
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14 Calibration
Calibration (cobas e 602 module) cobas ® 8000 modular analyzer series
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cobas ® 8000 modular analyzer series
QC
15 QC
Table of contents
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
15
Requesting QC measurements from QC > Status submenu ........................... B-200
Requesting QC measurements manually .......................................................... B-202
Unloading auto QC racks from the auto QC buffer ........................................ B-204
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Table of contents cobas ® 8000 modular analyzer series
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cobas ® 8000 modular analyzer series 15 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 Routine QC o Stand By Bottle QC o QC after Calibration o Timeout QC o Manual QC e
QC request from
Calib. and QC Select l l
(a) l
( Recommended button)
QC > Status
QC request from l l
(a) l l e See
Performing calibration and QC on page B-55.
See
Automatic QC request and measurement
(b) l e
See Automatic QC request on page B-193.
Table B-29 Different methods for QC requests
(b) QC after calibration can also be performed using automatic QC measurement (see
Automatic QC request on page B-193).
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Introduction
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).
e For more information about routine QC, see:
To perform QC during pre-routine operation on page B-197
To request controls for active reagents on page B-202
To program automatic QC request for Routine QC on page B-249
Standby reagent 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.
e For more information about standby reagent QC, see:
To perform QC during pre-routine operation on page B-197
To request controls for standby reagents on page B-203
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.
e For more information about QC after calibration, see:
To perform QC after calibration on page B-198
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.
e For more information about timeout QC, see:
To perform QC during routine operation on page B-198
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.
e See
Requesting QC measurements from QC > Status submenu on page B-200
To request controls for active reagents on page B-202
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Introduction
Automatic QC request
There are two different types of automatic QC measurement—Timeout QC and QC after Calibration. For Timeout QC and QC after Calibration it is possible to keep controls in the auto QC buffer—ready to be used any time before or during routine operation. When working with the auto QC buffer, define the on-board stability for the controls.
e See
To define the on-board stability for an auto QC on page B-267
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 buffer 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.
e See
To program auto QC measurements for timeout QC on page B-267.
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 buffer with a suitable control, the system performs automatic QC measurements after calibration without any intervention by the operator. e See
To program automatic QC measurements for QC after calibration on page B-249.
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15 QC
Introduction
Validation of QC
cobas ® 8000 modular analyzer series
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 and displayed on the QC > Run Status submenu.
e For more information on validation, see
To validate calibration and QC results on page B-58
e
For more information please refer to Part C Operation data manager
.
Barcode or non-barcode mode
CAUTION
Quality controls can be used either with or without barcodes. You must opt for permanently using either barcoded or non-barcoded QCs.
When working with barcodes, controls are automatically identified. If controls are processed without barcode or in non-barcode mode, 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.
If working with non-barcoded controls, ensure correct positions of the controls.
.
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 .
e
For more information, see Controls submenu on page B-206.
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Menu summary
Menu
Overview menu
15 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 .
e See
QC > Status submenu
QC > Run Status submenu e
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 and 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
See
The QC > Run Status submenu is used to perform the following: o To get an overview of the last 500 quality control (QC) measurements performed on the instrument o To view the most recent QC measurements for one particular test specified e See
Run Status submenu on page B-205.
Table B-30 Menu overview
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15 QC
Menu summary
Menu
QC > Controls submenu
QC > Install submenu
Table B-30 Menu overview cobas ® 8000 modular analyzer series
Function
The QC > Controls submenu is used to perform the following: o To review information about already registered controls.
They can either be downloaded or manually assigned by the operator o To assign controls to specific racks and positions e See
Controls submenu on page B-206.
The QC > Install submenu is used to perform the following: o To add, delete or download controls from the system o To activate/inactivate tests for the controls e See
Install submenu on page B-208.
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cobas ® 8000 modular analyzer series 15 QC
Overview menu
Overview menu
The following section explains QC tasks associated with the Overview menu.
Choose the Overview button in the menu line, or press <F12> 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 procedures to order QC during pre-routine and routine operation that we recommend. It also describes how to perform a QC after a calibration.
Calib. and QC Select a 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 .
Figure B-108
3
Print the load list.
Recommended QC workflow during pre-routine operation
Injury due to contact with rack loader mechanism
Only load or unload racks when the green status LEDs on the rack loader are on.
CAUTION
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.
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15 QC
Overview menu cobas ® 8000 modular analyzer series a To perform QC during routine operation
Timeout QC If the instrument issues a recommendation (timeout) for a QC measurement, request the QC measurement and start it.
1 Choose Calib. and QC Select button in the Overview menu, if it is highlighted yellow.
2 Request the recommended QC.
Figure B-109 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.
a To perform QC after calibration
QC after calibration 1 Choose Calib. and QC Select button in the Overview menu.
2 Request the calibration.
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Figure B-110 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
Calibration Load List and the QC Load List and start the measurement.
The QC rack must be loaded after the calibrator rack.
Operator’s Manual · Version 2.0
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Status submenu
To display this submenu, choose QC > Status .
15 QC
Status submenu
Figure B-111 QC > Status submenu
The QC > Status submenu displays all installed controls with the corresponding assigned and activated tests for each module and channel.
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.
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.
e
For more information, see Automatic QC request on page B-193.
Calculated tests Calculated tests are displayed on the QC >Status submenu if all parameters for the calculated test result are placed on the same module and the same reagent disk. In this case it is possible to perform QC for calculated tests.
If the parameters are not placed on the same reagent disk, calculated tests are gray shaded. In this case a request of the calculated test is flagged with Calc.?.
For a detailed description of all elements on this submenu, please refer to the Online
Help.
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Status submenu
Color scheme
The following colors are used in the QC Status list:
Color
Yellow
Yellow
Table B-31
Column Meaning
* The on-board stability is exceeded for controls in the auto
QC buffer.
Cause 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.
e
For more information, see Performing calibration and QC on page B-55.
Request recommended
QCs
(active reagents)
QC > Status submenu
Request
QCs manually
(active reagents)
Request routine QC
(active reagents)
Request standby reagent
QC
Stand By Bottle
QC
Select individual test
Routine QC
Assign
Save OK
Print QC Load List
Figure B-112 Requesting QCs from QC > Status submenu
The QC > Status submenu provides four options to request QC measurements:
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Status submenu
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.
e See
To perform QC during routine operation on page B-198
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.
e See
Requesting QC measurements manually on page B-202.
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. e See
Requesting QC measurements manually on page B-202.
Request standby reagent QC With this option you may request a single test or multiple test selected on the Stand
By Bottle QC window for QC measurements.
e See
Selecting tests for standby reagent QC on page B-203
o If expired controls are used on c 701 / c 502 modules and e 602 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.
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15 QC
Status submenu cobas ® 8000 modular analyzer series
Requesting QC measurements manually
a 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 appropriate test and control and measuring channel, if applicable. Multiple tests and controls and measuring channels can be selected.
Figure B-113 column.
QC workflow — selecting individual QCs
A check mark appears in the Select column. Manual is displayed in the Cause
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.
e
For detailed information, see To load required calibrators and controls on page B-57.
Routine QC does not include QC measurement for standby reagents. To perform controls for standby reagents, QC measurement must be requested separately.
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Status submenu
Selecting tests for standby reagent QC
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.
a To request controls for standby reagents
1
Choose QC > Status .
2
Choose Stand By Bottle QC to display the Stand By Bottle QC window.
Figure B-114 Stand By Bottle QC window
3
Select the appropriate test and control, and measuring channel if applicable.
Multiple tests and controls, and measuring channels 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.
e
For detailed information, see To load required calibrators and controls on page B-57.
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15 QC
Status submenu cobas ® 8000 modular analyzer series
Unloading auto QC racks from the auto QC buffer
a To unload auto QC racks from the auto QC buffer
1
Choose QC > Status > Unloading .
2
In the Unloading window select the rack(s) to be unloaded.
3
Choose Execute .
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.
o Do not use expired auto QCs. Unload the auto QC rack concerned, replace the expired control, and reload the rack onto the instrument.
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.
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Run Status submenu
To display this submenu, choose QC > Run Status.
15 QC
Run Status submenu
Figure B-115 QC > Run Status submenu
The Run Status submenu displays the control results processed on the data manager.
Use the 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 displays information that relates to the QC measurement selected on the chart.
Chart symbols
Today
Today
Past day
Past day
QC result falls out of SD (High / Low) value range.
QC result is within the SD (High / Low) value range.
QC result falls out of SD (High / Low) value range.
QC result is within the SD (High / Low) value range.
For a detailed description of all elements on this submenu, please refer to the Online
Help.
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15 QC
Controls submenu
Controls submenu
cobas ® 8000 modular analyzer series
To display this submenu, choose QC > Controls .
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Figure B-116 QC > Controls submenu
The QC > Controls submenu is used to view information about already registered controls and the current rack assignments.
If you are using controls without a barcode, you must assign a rack number and position to each control.
e For information about particular tasks associated with this submenu, see:
Assigning control positions on page B-207
For a detailed description of all elements on this submenu, please refer to the Online
Help.
If the Exp. Date column is highlighted in red, the corresponding control has expired.
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cobas ® 8000 modular analyzer series 15 QC
Controls submenu
Assigning control positions
Use the following procedure to assign a rack number and position to a control 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.
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.
a To assign racks and positions to controls
1 Choose QC > Controls .
2 Choose Rack Assign .
Figure B-117 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.
e
For more information about rack position assignment, see System submenu on page B-235.
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Install submenu
Install submenu
To display this submenu, choose QC > Install.
cobas ® 8000 modular analyzer series
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Figure B-118 QC > Install submenu
Use this submenu to add, delete or download controls from the system and to activate tests for the controls.
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.
e For information about particular tasks associated with this submenu, see:
Installing controls on page B-209
Inactivating and activating tests on page B-210
For a detailed description of all elements on this submenu, please refer to the Online
Help.
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cobas ® 8000 modular analyzer series 15 QC
Install submenu
Installing controls
Control data for available applications can be downloaded to the instrument from cobas link. An operator ID of supervisor level or higher is required for this operation.
The instrument must be in Standby.
e
If controls are used without barcodes, assign the control positions manually.
a To download control data from cobas link
1
Choose QC > Install.
2
On the submenu, select a free position in the control list and choose Download .
The Download window is displayed.
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Figure B-119 Download window (tentative window proposal)
3 Select one of the available search conditions ( All Item , Required Item , Control ,
Lot ID , or Release Date ). o The option Release Date refers to the date when the QC was released.
o The option Required Item refers to control information that was not found on the system at the time of installing controls into the instrument.
4
Choose Search to start searching for the selected criteria.
5
Select the check box(es) in the Selection column to download the necessary control information and choose Download .
6
Confirm the message on the confirmation window to start the download.
All necessary information, such as applications covered by the control, target mean values, and target SD values, is automatically stored by the system.
7
To run tests with a newly installed control, it is necessary to activate these tests.
e
See Inactivating and activating tests on page B-210.
B-209
15 QC
Install submenu cobas ® 8000 modular analyzer series
Inactivating and activating tests
All tests on board are automatically activated once the controls are installed. Tests can only be activated when the instrument is in Standby.
a 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 step 2 and 3 for all tests to be inactivated for that control.
a 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 step 2 and 3 for all tests to be activated for that control.
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Extended operation
Using various functions
16 Extended operation
Table of contents
Roche Diagnostics
Operator’s Manual · Version 2.0
This chapter contains additional information and tasks which are not required during the daily routine.
In this chapter Chapter
16
Measuring samples in Backup Operation mode .............................................. B-227
B-211
16 Extended operation
Table of contents cobas ® 8000 modular analyzer series
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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 B-120 Current instrument status
The following table shows the most important statuses:
Status Explanation
E.Stop
S.Stop
Power Up
Initialize
Standby
Preparation
Operation
Rack Reception Mode
Finalization
Status while the instrument is loading programs, performing self-checks etc.
Status while the instruments performs any kind of initialization
– after power up or before being operative.
Status when the instrument does not perform any measurement activities – but only a limited initialization or preparation is required.
Status while the instrument prepares any kind of reagent or other liquid.
Status while the instrument is pipetting, measuring or calculating.
After all test requests are completed, the instrument waits for additional samples. New samples will be processed automatically without the need to start a new analysis.
After Rack Reception Mode is 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 and then to Standby.
No new samples can be added via the loading port but the samples already past the barcode reader will be completed.
Statuses (modes) Table B-32
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Setting the time switch
Setting the 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.
Set the digital time switch
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 To set the present day and time
Example: Set the weekday and time to Wednesday, 15:20
1
Open the front panel of the core unit.
B
A Time switch
B Lid
Figure B-121
C D
Front panel of the core unit
C Core Load LED lights up for a few minutes after power-on (LED is used by Roche
Service personnel only)
D Timer toggle switch
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
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Setting the time switch
A
B
A MODE switch (P1, P2, RUN)
B Day keys
C Output setting switches (both must be set to: PULSE )
D Output ON/OFF switches (both must be set to: AUTO )
Figure B-122 Time switch
C D
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. The bar ( – ) mark at the Wednesday position turns on.
7 Set the time by pressing the h and min keys.
Holding the keys down rapidly advances the value. Pressing the Holiday key decreases the value of the key that was pressed last.
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 of the week.
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Setting the time switch cobas ® 8000 modular analyzer series a To set the start-up time for each day
Example: Set the start-up time to 8:30 a.m.
for Monday through Friday
(if different settings are required for each weekday, repeat steps 2 to 4)
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 on the bar ( – ) marks at the positions for Monday through Friday.
3
Set the start-up time by pressing the h and min keys. Press WRITE to save the setting.
4
Set the power-off time by pressing the h and min keys. Press WRITE to save the setting.
Automatic power-off
Although a power-off time must be set, the instrument cannot be powered off by the time switch!
o Both the power-on and power-off times must be set.
o Power off the instrument manually or use the Power Off Pipe function.
o The instrument cannot be powered off manually before the set power-off time. Set the earliest possible power-off time. It will have no consequences.
e
See Power Off Pipe function on page D-25.
Now you can activate the time switch.
a 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 on the left side 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. e For information on how to select a Power Up Pipe function, see:
Power Up Pipe function on page D-23.
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.
e
See Instrument inspection on page B-68.
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Setting the time switch
Check timer programming
a To check timer programming
1
Set the MODE switch to P1 .
2
Press WRITE repeatedly to display the programs already set.
3
Set the MODE switch to RUN .
Clear timer programming
Note: It is not possible to clear the program for single days.
a 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 .
a 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 3 seconds or more. The display indicates CLR - ALL .
4
Press WRITE to clear the settings. To cancel the clearing operation, press CLEAR while CLR is displayed.
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Installing the HbA1c application
Installing the HbA1c application
This section describes the necessary steps to use the HbA1c application (only available on c 502 modules).
e For general information on installing applications onto the instrument, see:
Installing or updating new applications on page B-257
Overview
Necessary applications To obtain results for HbA1c (%), the following applications are necessary:
Application/Reagent Short name Application code (ACN)
Hemolyzing reagent
Hemoglobin
Hemoglobin A1c
A1CD2
Hb-W2
A1-W2
952
870
880
% ratio of hemoglobin/hemoglobin A1c RWI2
Table B-33
890
Applications and reagents for the HbA1c (%) application
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Installing the HbA1c application
Reaction course The following figure shows the reaction course of the application:
1 Sample pipetting
For pipetting EDTA whole blood sample, the sample probe is lowered down to 70 % of the filling volume.
2 Hemolyzing process
EDTA whole blood sample is pipetted into predilution cuvette and is hemolyzed with hemolyzing reagent (A1CD2).
3 Hemoglobin analysis
Hemolyzed (prediluted) sample and R1 (Hb-W2 reagent) are pipetted.
o 1 Point assay o Cycle 1-34
4 Hemoglobin A1c analysis
R3 (A1-W2 reagent) is added.
o 2 Point assay o Cycle 34-70
A1CD2 reagent Hb-W2 reagent A1-W2 reagent
EDTA whole blood
Reaction cuvette Reaction cuvette
70 %
30 %
Predilution cuvette
Hemoglobin analysis
S, R1
0 o Sample (prediluted) +
R1 (Hb-W2 reagent)
34
R3
Hemoglobin A1c analysis o R3 (A1-W2 reagent) is added
Cycle (time)
70
Figure B-123 Reaction course of the HbA1c application
Result calculation The result for the Hemoglobin A1c analysis is calculated according to IFCC standardization:
Equation B-1 RWI 2 =
A1-W2
HB-W2
⋅ 100% (which means HbA 1 c % =
HbA
Hb
1 c
⋅ 100% )
This calculated test can be downloaded as application RWI2 (Application code 890)
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Installing the HbA1c application cobas ® 8000 modular analyzer series
Installing and configuring the application
To be able to utilize the HbA1c application on the system, you have to perform the following installation procedures:
1. Loading application parameters for the following applications:
O
Hemoglobin (Hb-W2, ACN 870)
O Hemoglobin A1c (A1-W2, ACN 880)
O
% ratio of hemoglobin/hemoglobin A1c (RWI2, ACN 890)
O Hemolyzing reagent (A1CD2, ACN 952) e
See Installing new application parameters on page B-258
2. Loading calibrator data for the following calibrator:
O
C.f.a.s HbA1c (674) e
See Installing calibrators on page B-169
3. To improve the fit of the nonlinear HbA1c calibration curve, a constant and lot independent 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. Loading control data for the following controls:
O
HbA1c Control N (357)
O HbA1c Control P (358) e
See Installing controls on page B-209
5. Setting the decimal places of the calculated test RWI2:
Roche recommends reporting the results to one decimal place.
6. Loading reagent packs for the following applications:
O
A1C-2: Hemoglobin (Hb-W2, ACN 870)/Hemoglobin A1c (A1-W2, ACN
880)
O A1CD2: Hemolyzing reagent (A1CD2, ACN 952)
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Installing the HbA1c application
Notes for the use of the application
Result calculation according to
DCCT/NGSP standardization
Roche provides the application RWI2 (Application code 890) to calculate the hemoglobin A1c% results according to IFCC standardization.
To report the results according to DCCT/NGSP standardization, you must configure the calculated test ACN 890 (under Utility > Application > Formula ):
Equation B-2 RWD 2 =
A1-W2
HB-W2
⋅ 87.6 % + 2.27
Sample container, sample pipetting
For processing the HbA1c whole blood application, the following tubes can be used:
Container
Primary sample tube
Sarstedt Monovette
(a)
BD Vacutainer
(b)
Sarstedt tube
(b)
Diameter
×
length
13 mm
×
75 mm
13 mm
×
100 mm
16 mm
×
75 mm
16 mm
×
100 mm
11 mm
×
66 mm
12 mm
×
75 mm
13 mm
×
75 mm
Volume
2.7 mL
3 mL
5 mL
Table B-34 Sample tubes for the HbA1c application
For HbA1c whole blood QC measurements, sample cups directly placed on a control rack can be used.
16 mm
×
100 mm 13 mL
(a) The rack range for the sample type Supernatant (Suprnt) must be defined on the Non-Standard tab under Utility > System > Rack Assignment .
(b) The rack range for the sample type Supernatant ( Suprnt ) must be defined on the Standard tab under
Utility > System > Rack Assignment .
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.
Clot detection Clot detection is automatically deactivated when pipetting whole blood samples.
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Automatic reruns
Automatic reruns
Rerun samples can be processed in two ways: as automatic reruns or as manual reruns.
Processing reruns
If a test result is flagged with a data alarm (e.g., the result is outside the technical limits, >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. e For information on data alarms that can cause an automatic rerun, see:
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 include or 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 is requested l
Rerun is performed l YES YES
YES NO l (a) l (a) l (a)
–
NO
NO
YES
NO
–
–
Table B-35 Correlation between the system-wide and the application-specific rerun setting
(a) The sample status changes back to Ordered (O) . An rerun can be performed by restarting the measurement.
System-wide setting The system-wide setting is displayed in the Automatic Rerun area on the Start window.
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Automatic reruns a 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 B-124 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.
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. This applies to data alarms which indicate that a result is outside the technical or repeat limit (>Test, <Test, >Rept, <Rept data alarms).
e For information on using the application-specific rerun setting, see:
Automatic Rerun (application-specific) on page B-266
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). In non-barcode mode, manual reruns can only be performed for STAT samples.
e For information about performing manual reruns, see:
Performing manual reruns on page B-79.
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Automatic reruns cobas ® 8000 modular analyzer series
Reruns with diluted samples
In case 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.
Decreased sample volume
Increased sample volume
Diluted sample
ISE module l (a)
–
– c 701 and c 502 modules l l l e 602 module l (b)
– l
Table B-36 Availability of dilutions for reruns
(a) available only for urine samples as a manual rerun
(b) If decreased is selected in the Test Selection submenu and in the data manager, the sample uses the dilution ration defined on Utility > Application > Range .
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).
e Refer to the package insert of the respective application for recommended dilutions.
Make sure that sufficient module-specific diluents are loaded to dilute samples.
Automatic dilutions Individual tests can be configured with a dilution for the first run and/or rerun.
Dilutions defined in the instrument software are automatically performed and calculated by the instrument. Administrator access is required to define these dilution parameters ( Utility > Application submenu).
Manually requested dilutions Dilutions can be requested by the operator. 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
When using dilution ratios different from the recommended ratios for the application, you must validate the dilution behavior of the application.
e
For more information, see Requesting a test manually on page B-76.
Request from LIS Dilutions can also be requested by the LIS. In this case, the samples are in the unloader and have to be reloaded and processed again.
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Prediluted samples
16 Extended operation
Automatic reruns
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.)
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.
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Backup Operation
Backup Operation
cobas ® 8000 modular analyzer series
The Backup Operation mode can be useful if the rack loader/unloader 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). o Backup Operation mode is available only if barcode mode is selected.
o Backup Operation mode is available on all modules at a time.
a 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 B-125 Overview menu
The Module window for the corresponding module sample buffer is displayed.
Roche Diagnostics
B-226
Figure B-126 Module window – module sample buffer
2
Choose Backup Operation .
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cobas ® 8000 modular analyzer series 16 Extended operation
Backup Operation
3 When the instrument goes into Backup Operation status, the instrument is ready to measure samples. e
See Measuring samples in Backup Operation mode on page B-227
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.
A
A Module sample buffer
Figure B-127 Backup operation port
B
B Backup operation port
Before performing the following actions, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Incorrect results and interruption of analysis due to contaminated samples on page A-11
o
Infection and injury due to contact with instrument mechanism on page B-3
o
Interrupt of operation due to interlock system on page B-4
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Operator’s Manual · Version 2.0
a To measure samples in Backup Operation mode
1 Activate the Backup Operation mode.
e
See To activate the Backup Operation mode on page B-226
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…).
B-227
16 Extended operation
Backup Operation
NOTICE cobas ® 8000 modular analyzer series
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 could not be detected, which may possibly lead to instrument damage.
o Ensure the correct orientation of the rack.
o 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.
a To unload racks in Backup Operation mode
After all test requests are completed, sampling stops and the Backup Collect button in the Module window is available.
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 .
e
See To measure samples in Backup Operation mode on page B-227.
5
Repeat steps 1 to 4 until all samples are measured.
6 Switch off the Backup Operation mode, after all samples are measured.
e
See To switch off the Backup Operation mode on page B-228.
a To switch off the Backup Operation mode
1
Choose Stop (global button).
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Preparing a DVD disk
Preparing a DVD disk
The cobas 8000 control unit computers are equipped with a DVD disk drive. The
DVD disk drive can be used for installing software updates and backing up and restoring data.
The following DVD formats can be used: o DVD-R o
DVD+R o DVD-RW o
DVD+RW
The preparation of a DVD disk consists of two steps:
1. DVD disks require formatting before use.
e
See Formatting a DVD disk on page B-229
2. If you want to use the DVD disk on computers other than the cobas 8000 control unit computer, the DVD disk must be made compatible after the backup.
e
See Making a DVD disk compatible on page B-230
Formatting a DVD disk
NOTICE
DVD-R and DVD+R disks can be formatted once only. DVD-RW and DVD+RW disks can be formatted several times.
Danger of data loss
Formatting a DVD-RW or DVD+RW disk deletes all data on the disk.
o Before formatting a DVD disk, make sure that no important data is stored on the disk.
a To format a DVD disk
1 Make sure the analyzer is in standby.
2 Insert a new DVD disk into the DVD drive.
3 Press <Ctrl>+<F7> to display the Format window.
4 Choose Quick (erase) or Full from the Format type area.
Depending on the type of DVD disk, only Full is available.
5 Choose Start and confirm the formatting process with OK .
The DVD disk is formatted. This may take several minutes.
6 After formatting is finished, confirm with OK .
The DVD disk is ready for a data backup now.
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Operator’s Manual · Version 2.0
To back up patient results on a DVD, choose Workplace > Data Review > Backup
Data .
e For information on how to back up results, see:
Archiving patient data on page B-90.
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cobas ® 8000 modular analyzer series 16 Extended operation
Preparing a DVD disk
Making a DVD disk compatible
A DVD disk must be made compatible ( finalized or closed ) if you want to use it on computers other than the cobas 8000 control unit computer.
Finalizing a DVD-R or
DVD+R disk
After making the DVD disk compatible, no more data can be stored on the DVD-R or DVD+R disk. The disk is finalized .
Closing a DVD-RW disk A DVD-RW can store additional data after being made compatible. The disk is not finalized, it is only closed . After storing additional data on the DVD-RW disk, the disk needs to be closed again.
A DVD+RW disk can be used on other computers without being made compatible.
a To make a DVD disk compatible
1
Make sure the analyzer is in standby.
2
Insert the DVD disk into the DVD drive.
3
Press <Ctrl>+<F8> to display the Compatibility window.
4
Choose Start and confirm the process with OK .
The DVD disk is made compatible. This may take several minutes.
5
After making it compatible is finished, confirm with OK .
The DVD disk is ready to be used on other computers.
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Archiving data and performing data backups
Archiving data and performing data backups
Data type
Test results
(patient data)
Important data, configurable
(a)
The instrument software manages several types of data and provides the following storage routines. CDs or DVDs can be used as storage media.
Storage routine
Sending/Archiving after measurement
Backup function
(daily)
Target
1. to the data manager
2. to a storage medium to the data manager
To be performed automatically (or manually via Workplace > Data Review >
Send 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)
System parameters Backup after
(re)programming to a storage medium via Utility > Maintenance > Parameter Read/Write
Reports Backup to a storage medium via Print > History > Backup
Figure B-128 Overview of data types and possible storage routines
(a) 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
Back up your data (measurement results and system parameters) at regular intervals.
a To minimize the risk of data loss, perform the following routines:
1
Make sure that all test results are archived on the data manager , LIS and/or make a backup copy on DVDs.
e For more information, see:
Archiving patient data on page B-90
2
We recommend using the backup function in a daily maintenance pipe to store relevant data on the hard disk of the data manager. e For more information, see:
(26) Essential Information Upload on page D-40
3
Make a backup copy if you have changed any system parameters (e.g., application
parameters, see Table B-37 on page B-236).
e For more information, see:
Saving system parameters on page B-253
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Archiving data and performing data backups cobas ® 8000 modular analyzer series
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B-232 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Utility
Configuring the instrument
17 Utility
Table of contents
This chapter describes the configuration of the cobas® 8000 instrument.
Roche Diagnostics
Operator’s Manual · Version 2.0
In this chapter Chapter
17
Yellow / Purple alarm settings overview ..................................................... B-252
Installing or updating new applications ...................................................... B-257
Description of application parameters ........................................................ B-259
B-233
17 Utility
Table of contents cobas ® 8000 modular analyzer series
Automatic Rerun (application-specific) ...................................................... B-266
Programming a special wash (cobas c 701 and c 502 modules) ..................... B-271
Programming a special wash (cobas e 602 module) ........................................ B-277
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System submenu
17 Utility
System submenu
This section explains how to perform certain tasks associated with the Utility >
System submenu.
The entire module set (module configuration, test assignment) should be set up before the other settings (control, calibrator settings) e For more information on configuring the modules, see
System Configuration submenu on page B-280
To display this submenu, choose Utility > System .
Figure B-129 Utility > System submenu e For information about particular tasks associated with this submenu, see:
Programming system parameters on page B-235
Assigning tests or profiles to test keys on page B-243
Configuring automatic QC on page B-249
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.
After (re)programming system parameters, it is strongly recommended that you make a backup disk. However, some items cannot be saved to disk.
e See
Saving system parameters on page B-253.
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17 Utility
System submenu cobas ® 8000 modular analyzer series
System parameter Menu/window
Assign Operator IDs
Assign Rack Numbers
Set the Barcode Mode
Add/Edit a Profile
Set the Printer Page Size
Utility > System > Operator List
Utility > System > Rack Assignment
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
Utility > System > Key Settings
Utility > System > Key Settings
Utility > System > Key Setting > Profile
Setting
Utility > System > Print Settings
Print Dilution Ratio
Define Comment Titles
Set Date and Time
Set the Screen Saver
Set the Order (Name/Test No.)
Define Rack Reception Mode
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
Utility > System > Wash Racks
Start Cell No. Incremental
Wash Rack Sampling
Define Rack Delivery Setting
Define Sample Tube Rotation
Maintenance Settings
Pipe Settings
Power Up Pipe Settings
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 > Alarm Settings Define Alarm Settings
Define QC Settings
Activate Calibration Mask Settings
Define Reagent Level Check Alarms
Check Diluents and Cleaners
Utility > System > Calib. and QC Settings
Utility > System > Calib. and QC Settings
Utility > System > Reagent Level
Utility > System > Utility Reagent Settings
Utility > System > ISE Calib. Setting
Start (global button) > Start Up Pipe Setting
Define ISE Calib Setting
Define a Start Up pipe
Activate Automatic Rerun
Define test and patient masking
Program Default Profiles
Set Alarm Sounds
Table B-37 System parameters
Start (global button) > Automatic Rerun
Start (global button) > Masking
Start (global button) > Default Profile
Alarm (global button) > Sound
For more information about system settings, please refer to the Online Help of the
Utility menu or contact your Roche service representative.
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17 Utility
System submenu cobas ® 8000 modular analyzer series
Operator ID settings
Administrator
Supervisor
Operator
Table B-38 Access levels
Figure B-130 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
Access rights
System configuration and maintenance settings
Supervisor
Operator
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.
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17 Utility
System submenu cobas ® 8000 modular analyzer series
Rack Assignment
Use the Rack Assignment window to assign rack ranges for routine, rerun and STAT samples for each sample type. The rack assignment must be done for the standard tubes, for non-standard tubes, and for false bottom tubes.
e
For more information about the different rack types, see Rack classes and colors on page A-69.
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.
The ranges have to be defined for routine racks (first run) and for rerun racks
(second rerun).
Rerun racks Using different racks for first run and rerun samples is only necessary in sample mode (sample barcode reader off) 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 (1 - 999) 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.
Mixing sample types on one rack If you want to place samples of different types on one rack, you have to define a rack range for the sample type None and use a rack from the defined rack range. In this case the sample type must be downloaded and a unique ID must be assigned to each sample type.
Racks for immunoassays For immunoassays, the sample type Ser/Pl and Urine are available as sample types. It is not possible to use racks assigned for CSF or Suprnt.
Standard tab
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Figure B-131 Rack Assignment window - Standard tab
Use the Standard tab to assign rack ranges for the use of standard tubes.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Standard tubes are available in the following dimensions: o 13 mm
×
75 mm o
13 mm
×
100 mm o 16 mm
×
75 mm o
16 mm
×
100 mm
Tubes with other dimensions must be defined on the Non-Standard tab.
17 Utility
System submenu
Non-Standard tab
Figure B-132 Rack Assignment window - Non-Standard tab
Use the Non-Standard tab to assign rack ranges for the use of non-standard tubes.
Non-standard tubes must have the following dimensions: o Length between 73 mm and 102 mm (equivalent to 60 mm + Hitachi cup) o
Outer diameter between 12 mm and 16 mm
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17 Utility
System submenu
False Bottom tabs cobas ® 8000 modular analyzer series
Roche Diagnostics
B-240
Figure B-133 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.
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 B-134 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
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
System submenu
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.
Bottom Level
(15 mm for example)
Adjusting sample probe setting for false bottom tubes
A
A Rubber holder for the tube (inside the rack)
Figure B-135 False bottom tube settings
If you use tubes with a conical bottom, select Conical bottom .
When using false bottom tubes or microcups 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 or microcups 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.
a 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.
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17 Utility
System submenu
Module Settings cobas ® 8000 modular analyzer series
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Figure B-136 Rack Assignment window - Module Settings tab
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 done on all modules at the same time.
At the bottom of this window, a rack range for auto QC racks can be defined. A QC rack within this rack range remains on the auto QC buffer until it is unloaded from the auto QC buffer on the Unloading window ( QC > Status > Unloading ).
Only standard tubes can be used for auto. QCs.
a 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 .
e For more information about auto QC, see:
To program automatic QC measurements for QC after calibration on page B-249
To program auto QC measurements for timeout QC on page B-267
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Assigning tests or profiles to test keys
a To display the Key Settings window
1
Choose Utility > System .
2
Choose Key Settings .
17 Utility
System submenu
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-137 Key Settings window
The Key Settings window is used to assign tests or profiles to test keys. 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 with only one test key. a To define a group name
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.
B-243
17 Utility
System submenu cobas ® 8000 modular analyzer series a To define a profile
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.
Figure B-138 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.
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.
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cobas ® 8000 modular analyzer series 17 Utility
System submenu a 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.
Figure B-139 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.
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cobas ® 8000 modular analyzer series 17 Utility
System submenu
Rack Reception
Figure B-140 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 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 rack reception mode, the system automatically turns to Standby after the sample result is generated.
For an analysis started with active rack reception mode, the system remains in operation after the last sample result is generated and until one of the following occurs:
Action Result
Specified time is elapsed
S.Stop button is chosen
System goes into Standby
System goes into Standby
Stop button is chosen
A red alarm is issued
System goes into Standby
System goes into Standby
A wash rack is loaded
Table B-39
The wash rack is processed and then the system goes into Standby
Stopping the system in rack reception mode
The remaining time for rack reception mode is shown in the status line.
Photometric Stop Washing During operation and rack reception mode the reaction cells are continuously washed. To disable the washing function, select the Stop Washing check box. If the check box is selected the washing stops after the last sample is processed and the reaction cell of this sample is washed.
Cell washing is automatically enabled when the next analysis is started.
This check box is available only if rack reception mode is selected.
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Rack Delivery
17 Utility
System submenu
Figure B-141 Rack Delivery window
STAT Rack number Set the number of slots in the module sample buffer that are reserved for STAT racks
(0 to 19). The reserved number of slots will be used by the STAT racks.
At least one position should be reserved 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 .
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) e For information, see:
Defining and editing maintenance types on page D-28
Defining and editing maintenance pipes on page D-20
Power Up Pipe function on page D-23
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Operator’s Manual · Version 2.0
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17 Utility
System submenu
Calib. and QC Settings
cobas ® 8000 modular analyzer series
Figure B-142 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.
a 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.
e
See To define application auto masking on page B-264
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.
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.
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Configuring automatic QC a 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 and choose OK .
17 Utility
System submenu
When this 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.
o With non-barcoded controls, a QC rack which is not defined for automatic QC should be used and the controls have to be placed in the defined positions.
o
With barcoded controls, any QC rack with barcoded controls is loaded.
a 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 and choose OK .
3 Assign control racks for auto QC.
e
See To assign control racks for auto QC on page B-242.
If the Auto. QC with QC after Calibration function is selected and if there is an auto
QC rack in the auto QC buffer with a suitable control, the system performs automatic
QC measurements after calibration without any intervention by the operator.
Roche Diagnostics
Operator’s Manual · Version 2.0
B-249
17 Utility
System submenu
Reagent Level
cobas ® 8000 modular analyzer series
Roche Diagnostics
B-250
Figure B-143 Reagent Level window
Red
Yellow
This window is used to define the level of reagent 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
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.
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.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
System submenu
Setting a yellow alarm / purple alarm
Both the yellow alarm level and the purple alarm level are set for individual tests by number of tests remaining; for wash solutions and diluents by mL remaining.
a 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.
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Operator’s Manual · Version 2.0
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17 Utility
System submenu cobas ® 8000 modular analyzer series
Yellow / Purple alarm settings overview
Module name Type/Test c c c c c c c c c c c c c
ISE
701
701
701
701
701
701
701
502
502
502
502
502
502
Comment Input range yellow alarm
An alarm can be activated if ISE is detected.
0 - 9999 tests Reagent (ISE IS, ISE DIL,
ISE REF (KCl)
Reagent pack
Special reagent
Diluent (DIL)
Wash solution for reagent probes (Washer D1 - D2)
Wash solution for sample probe (SmpCln 1,
SmpCln 2)
Additive for incubator bath
(Hitergent)
Wash solution for cuvettes
(CellCln 1, CellCln 2)
Reagent pack
Diluent (DIL)
Wash solution for reagent probes (Washer D1 - D3)
Wash solution for sample probe (SmpCln 1,
SmpCln 2)
Additive for incubator bath
(Hitergent)
Wash solution for cuvettes
(CellCln 1, CellCln 2)
Number of determinations in a reagent pack. 0 - 9999 tests
Volume warning level for special reagents
(SPR)
0 - 9999 ml
0 - 9999 ml 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 (NaOH-D, SMS)
0 - 9999 ml
Volume warning level for the wash solution in the container
0 - 9999 ml
Volume warning level for the wash solution in reagent pack (Hitergent); only purple
0 - 9999 ml alarm possible.
Volume warning level for the wash solution in reagent container (NaOH-D, Acid Wash)
0 - 9999 ml
Number of determinations in a reagent pack. 0 - 9999 tests
0 - 9999 ml 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 (NaOH-D, SMS, SCCS)
Volume warning level for the wash solution in the container
0 - 9999 ml
0 - 9999 ml
Volume warning level for the wash solution in reagent pack (Hitergent); only purple alarm possible.
Volume warning level for the wash solution in reagent container (NaOH-D, Acid Wash)
0 - 9999 ml
0 - 9999 ml
Input range purple alarm
0 - 9999 tests
0 - 9999 tests
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 tests
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml
0 - 9999 ml e 602 e 602
Table B-40 cobas e pack
Diluent (DIL)
Number of determination in a cobas e pack 0 - 9999 tests
Volume warning level for diluent
Yellow / Purple alarm settings overview
0 - 9999 ml
0 - 9999 tests
0 - 9999 ml
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cobas ® 8000 modular analyzer series 17 Utility
Maintenance submenu
Maintenance submenu
This chapter describes how to make a backup of system parameters and how to restore system parameters from a backup.
e For more information, see:
Saving system parameters on page B-253
Restoring system parameters on page B-255.
The configuration of maintenance related items is described in the corresponding maintenance chapters.
e
For information, see: Chapter 26 Maintenance .
Saving system parameters
Use the following procedure to make a backup of system parameters on a storage medium (CD or DVD). This information can be restored by using the Parameter
Read option in the Parameter Read/Write window, if required.
e See
Restoring system parameters on page B-255.
a 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
Operator’s Manual · Version 2.0
Figure B-144 Utility > Maintenance submenu
4 Select Maintenance from the Maintenance Type list.
5 Select
(14) Parameter Read/Write from the
Maintenance Items list.
6 Choose Select to display the Parameter Read/Write window.
B-253
17 Utility
Maintenance submenu cobas ® 8000 modular analyzer series
Roche Diagnostics
B-254
Figure B-145 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:
Application settings
Special wash settings
System settings
Calculated and compensated test settings
Alarm settings
Comment Settings
Data manager communication settings
Maintenance pipe settings
Operator ID setting parameters
Barcode check digit settings
Profile settings Power up pipe settings
Utility reagent settings
Start settings
Key settings
Channel assignment parameters
Table B-41
Scale settings for each graph
Data manager settings
CLAS settings
Module settings
System parameters stored by Parameter Read/Write function
8 When processing is complete, remove the storage medium from the control unit computer.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
Maintenance submenu
Restoring system parameters
Use the following procedure to restore system parameters from a storage medium.
a 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.
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17 Utility
Application submenu
Application submenu
cobas ® 8000 modular analyzer series
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.
Overview
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 B-42 Fixed test numbers
Test name
Na
K
Cl
Serum index L
Serum index H
Serum index I
Calculated tests
General information for immunoassays
Development channel applications
CAUTION
Up to 100 heterogeneous immunoassays can be installed, irrespective of the number of modules. Applications can be assigned individually to each module and measuring cell (e1-1, e1-2 and e2-1, e2-2) using Utility > System > Test Assignment .
A development channel application has to be installed via cobas link. All application fields are accessible and parameters can be entered manually.
Incorrect results when using development channel applications
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.
A description for loading Development Channel applications is available on cobas link.
Refer to the Instructions for Use for 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 have to be installed via cobas link. Otherwise, the reagent pack will be rejected by the system and the test will not be displayed correctly on different submenus of the Reagent , Calibration and the Utility menu.
e Refer to the following sections to get information about:
Installing new application parameters on page B-258
Description of application parameters on page B-259
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cobas ® 8000 modular analyzer series 17 Utility
Application submenu
Installing or updating new applications
To be able to utilize a new application on the instrument, you have to perform the following installation steps:
1. Install application parameters. Customize the default parameters if necessary.
If you install new application parameters, make sure that the correct units for these parameters are selected. After installing the application parameters a change of the units is no longer possible.
e For more information, see:
Installing new application parameters on page B-258
Description of application parameters on page B-259
2. Install calibrator data.
e
See Installing calibrators on page B-169
3. Install and activate the control data for the new application.
e
See Installing controls on page B-209
4. Assign rack positions for calibrator and controls (only necessary when working with non-barcoded calibrators or controls) e For more information, see:
Assigning calibrator positions on page B-167
Assigning control positions on page B-207
5. Add special wash if applicable.
e
6. Define a key setting for the new application.
e
See Special Wash submenu on page B-270
See To assign a test or a profile to a key on page B-245
7. Define reagent level; check alarm levels if necessary.
e
See To define a yellow / purple alarm level on page B-251
8. Load reagents onto the instrument.
e For more information, see:
Loading reagents (cobas ISE module) on page B-106
Loading reagents (cobas c 701 module) on page B-117
Loading reagents (cobas c 502 module) on page B-129
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Operator’s Manual · Version 2.0
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17 Utility
Application submenu cobas ® 8000 modular analyzer series
Installing new application parameters
This procedure can be performed by operators with administrator level password only.
a To download application parameters from cobas link
1
Choose Utility > Application to display the Application submenu.
2
Choose Download to start the download of information about additional applications.
Roche Diagnostics
B-258
Figure B-146 Download window (application)
3
Select one of the available search conditions ( All Item , Required Item ,
Application Code , Application Name , R. Pack ID , or Release Date ). o
The option Required Item refers to application information that was not found on the system at the time of installing applications into the instrument.
o The option Release Date refers to the date when the application was released.
4 Choose Search to start searching for the selected criteria. The search results are displayed in the Result area.
In the Comment column, you can find additional information about the application, such as the reason for change.
5 Mark the check box in the Selection column to download the corresponding application, and choose Download .
The application parameters of the downloaded application are displayed on the
Application submenu. Some parameters are user-definable.
e
See Description of application parameters on page B-259.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
Application submenu
Description of application parameters
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.
CAUTION
Incorrect results due to modifying application parameters
Changing an application setting may affect the validity of results.
Check the new settings before using them. e e
For instructions on changing default application parameters on the Analyze parameter,
see: To define application dilution ratios (e 602) on page B-261
For instructions on changing default application parameters on the Calib.
parameter, see:
To define calibration timeouts on page B-263
To define application auto masking on page B-264
To define the application duplicate limit (e 602) on page B-264
e For instructions on changing default application parameters on the Range parameter, see:
To change technical limit (photometric tests) on page B-267
To change the repeat limit on page B-268
To change qualitative fields (photometric tests) on page B-268
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Operator’s Manual · Version 2.0
B-259
17 Utility
Application submenu
Analyze parameters
cobas ® 8000 modular analyzer series
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 .
Figure B-147 Analyze parameters on Utility > Application submenu (immune tests)
Roche Diagnostics
B-260
Figure B-148 Analyze parameters on Utility > Application submenu (photometric tests)
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
Application submenu
Dilution ratios (cobas e 602 module) a 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
Select the required dilution for the first run in the For 1st list box and for reruns in the For Rerun list box of the Default Dilution Ratio area.
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.
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
Operator’s Manual · Version 2.0
Figure B-149 Calib. parameters on Utility > Application submenu (Photometric test)
B-261
17 Utility
Application submenu cobas ® 8000 modular analyzer series
Figure B-150 Calib. parameters on Utility > Application submenu (ISE test)
Figure B-151 Calib. parameters on Utility > Application submenu (Immune test) e For instructions on changing default application parameters on the Calib. parameters, see:
To define calibration timeouts on page B-263
To define application auto masking on page B-264
To define the application duplicate limit (e 602) on page B-264
Operator’s Manual · Version 2.0
Roche Diagnostics
B-262
cobas ® 8000 modular analyzer series
Auto Calibration
17 Utility
Application submenu
Calibration can be recommended automatically in various cases (see
Automatic calibrations on page B-156). In the
Auto. Calibration area, the cause for automatic calibration request is defined for each application.
Roche Diagnostics
Operator’s Manual · Version 2.0
A Photometric test B ISE tests
C Immune test
Figure B-152 Auto. Calibration area
When you load a new application onto the system, the time-triggered calibration
(Timeout) is activated by default. e e
For more information, see:
Automatic calibrations on page B-156
To define calibration timeouts on page B-263
For more information how to activate QC Violation, please refer to Part C Operation data manager .
a To define calibration timeouts
1
Choose Utility > Application > Calib.
2
Select the test to be edited from the Test list on the left.
For e 602 applications:
Before selecting the Timeout check box and defining timeout periods, please check the package insert of the application on cobas link. If the check box is not selected, the default values read from the cobas e pack parameter are used (in most cases 7 days for cobas e pack stability and 28 days for lot stability).
3
In the Timeout area, define the required calibration method and the timeout period: o
For c module applications:
O Select the calibration method for lot calibration from the corresponding list box.
O
Type the required timeout period for lot calibration in the corresponding text box and select the time unit from the corresponding list box.
O Repeat the last two steps for the R. Pack calibration.
o
For ISE applications:
O Select the calibration method from the corresponding list box.
O
Type the required timeout period for ISE calibration, in days, in the corresponding text box.
B-263
17 Utility
Application submenu cobas ® 8000 modular analyzer series o For e 602 applications:
O
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.
O 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.
Calibration masking
If the calibration of a test fails and Auto. Masking is selected, this test will be masked automatically.
a 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.
To activate the auto calibration masking function, select the Auto. Masking check box on Utility > System > Calib. and QC Settings .
Duplicate limit (cobas e 602 module)
All Roche e 602 calibrators have a default duplicate limit of 10%. For some applications it is necessary to change the duplicate limit value.
a 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.
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cobas ® 8000 modular analyzer series
Range parameters
17 Utility
Application submenu
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 B-153 Range parameters on Utility > Application submenu (Photometric test)
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-154 Range parameters on Utility > Application submenu (ISE test)
B-265
17 Utility
Application submenu cobas ® 8000 modular analyzer series
Figure B-155 Range parameters on Utility > Application submenu (Immune test) e For instructions on changing default application parameters on the Range tab, see:
To define application automatic rerun on page B-266
To change technical limit (photometric tests) on page B-267
To change the repeat limit on page B-268
To change qualitative fields (photometric tests) on page B-268
Automatic Rerun (application-specific)
If the Automatic Rerun check box is selected, the test is automatically performed for rerun each time a result is flagged with a specific data alarm. a 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.
e For more information, see
Processing reruns on page B-222
If automatic rerun is selected, the sample remains on the module sample buffer until the results of the sample are available.
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cobas ® 8000 modular analyzer series 17 Utility
Application submenu
Configuring automatic QC a To program auto 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.
e
See To assign control racks for auto QC on page B-242.
When the specified time has elapsed, a QC request is triggered. If an auto QC rack with a suitable control is located in the auto QC buffer, the system performs automatic QC measurements without any intervention by the operator. The control is measured with the active (in use) reagent packs.
a 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.
Technical limit (photometric tests)
3 Specify a time interval from 1 to 99 hours.
If AutoQC racks are used and a control expires (on-board stability exceeded), the system displays the yellow alarm.
The technical limit reflects the analyte concentration range within which the relation between measured signal (absorbance or rate of change in absorbance) and concentration is well defined. A lower and upper technical limit is set for each application. Recommended values are transferred via cobas link.
Any measurement with a result below the lower technical limit (<Test data alarm) is repeated with increased volume. Any measurement with a result over the upper technical limit (>Test data alarm) is repeated with decreased volume.
a To change technical limit (photometric tests)
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.
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17 Utility
Application submenu
Repeat limit cobas ® 8000 modular analyzer series
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.
e
For more information, see Processing reruns on page B-222
a 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.
For photometric tests, the concentration range of the Repeat Limit must be within the
Technical Limit .
4 Choose Save to save the changes.
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. a 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
Repeat steps 4 to 5 for numbers (2) to (6).
7 Choose Save to save the changes.
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Other parameters
17 Utility
Application submenu
The following sections explain certain settings associated with the Other parameters on Utility > Application submenu. Not all settings are described, but the most important ones.
To display this submenu, select Utility > Application > Other .
Figure B-156 Other parameters on Utility > Application submenu (photometric test)
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Operator’s Manual · Version 2.0
Figure B-157 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 .
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17 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
B-270
Figure B-158 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 ).
Regularly download special washes when the Parameter Download button is red on the
Overview menu. This ensures the correctness and completeness of the programmed special washes for the installed applications.
Downloaded special washes are displayed in the Manufacturer Rule list. Further special washes can be programmed and are displayed in the User Rule list.
e The following sections explain how to set the carryover avoidance function.
Programming a special wash (cobas c 701 and c 502 modules) on page B-271
Programming a special wash (cobas e 602 module) on page B-277
Installing special wash parameters on page B-279
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
Special Wash submenu
Programming a special wash (cobas c 701 and c 502 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
The reagent probes dip into the reagents when aspirating. To avoid a reagent carryover, program a special wash cycle for the reagent probe.
a To program a reagent probe wash
1
Choose Utility > Special Wash > Reagent Probe .
Figure B-159 Reagent Probe window (chemistry)
2
Select a c-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 · Version 2.0
Figure B-160 Edit (Reagent Probe) window (chemistry)
5 In the Probe list, select R1 or R2 to designate which reagent probe is to be washed.
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17 Utility
Special Wash submenu cobas ® 8000 modular analyzer series
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.
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 add the new special wash to the list on the User Rule area and to close the window.
10
Check the amount of the appropriate detergent on the instrument on the
Reagent > Status submenu.
a 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.
Cell wash
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.
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cobas ® 8000 modular analyzer series a To program a cell wash
1 Choose Utility > Special Wash > Cell .
17 Utility
Special Wash submenu
Figure B-161 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 · Version 2.0
Figure B-162 Edit (Cell) window
5 Select a test from the Test list that may cause carryover.
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 wash solution volume (from 20 to 180
μ
L) in the Volume text box.
7
R2/3 column.
8 Choose OK to save the settings, to add the programming to the User Rule area and to close the window.
9 Check the amount of the appropriate detergent on the instrument on the
Reagent > Status submenu.
B-273
17 Utility
Special Wash submenu cobas ® 8000 modular analyzer series a 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.
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Sample probe wash
17 Utility
Special Wash submenu
The sample probe dips into the sample when it aspirates 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. a To program a sample probe wash
1
Choose Utility > Special Wash > Sample Probe .
Figure B-163 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.
4
Choose Edit to display the Edit (Sample Probe) window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-164 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
B-275
17 Utility
Special Wash submenu cobas ® 8000 modular analyzer series
The detergent aspiration volume is 60
μ
L.
8 Choose OK to save the settings.
9 Check that the appropriate wash solution is placed on the instrument in the correct position.
1 SmpCln 1 (basic wash)
2 SmpCln 2 (acid wash)
Figure B-165 Sample probe cleaners ( c 502 module for example)
10
Check the amount of the appropriate detergent on the Reagent > Status submenu.
a 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.
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cobas ® 8000 modular analyzer series 17 Utility
Special Wash submenu
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.
a To program a reagent probe wash
1
Choose Utility > Special Wash > Reagent Probe .
Figure B-166 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.
4
Choose Edit to display the Edit (Reagent Probe) window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-167 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.
B-277
17 Utility
Special Wash submenu cobas ® 8000 modular analyzer series 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 Step 0 is used for pretreatment or diluent.
O
Step 1 is the pipetting step before the first incubation.
O Step 2 is the 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 add the new special wash to the list on the User Rule area and to close the window.
Sample probe wash
In the context of e 602 special washes, the term sample probe refers to the sample probe of the c 701 or c 502, not to the e 602 sample probe.
Prior to pipetting the c 701 or c 502 test, the sample probe of the c 701 or c 502 is
If a sample has been processed on c 701 or c 502 before an e 602 assay is performed and a special wash for the sample probe of the c 701 or c 502 has been performed, a b-flag is displayed for this sample on the Data Review submenu.
e washed with the specified reagent if afterwards an e 602 test is requested.
See
To program a sample probe wash on page B-275
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cobas ® 8000 modular analyzer series 17 Utility
Special Wash submenu
Installing special wash parameters
Special wash parameters can be downloaded to the instrument from the data manager using the online support function.
a To install special wash parameters
1
Choose Utility > Special Wash > Download.
Figure B-168 Download window - special wash
Type , or Release Date ).
2
Select one of the available search conditions ( All Item , Required Item , Module
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 .
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B-279
17 Utility
System Configuration submenu
System Configuration submenu
cobas ® 8000 modular analyzer series
This section explains how to perform certain tasks associated with entire modules rather than specific samples or tests.
e Refer to the following procedures to get information about:
Assigning a test to a module on page B-281
Powering off a module on page B-284
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.
Figure B-169 Utility > System Configuration submenu
This submenu is used to access the Test Assignment, Module Settings, and
CLAS Settings.
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cobas ® 8000 modular analyzer series 17 Utility
System Configuration submenu
Assigning a test to a module
Use the following procedures to assign a test to the corresponding module.
e For more information see:
To assign tests to the ISE module on page B-281
To assign tests to a c module on page B-282
To assign a test to an e 602 module on page B-283.
a 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 B-170 Test Assignment (ISE) window
3 Select Na, K, Cl or Na, K.
o Na, K, Cl: This option allows sodium (Na ion testing on this ISE module.
+
), potassium (K
+
) and chloride (Cl
-
) o
Na, K: This option allows only sodium (Na) and potassium (K) testing on this
ISE module.
4
Choose OK .
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17 Utility
System Configuration submenu cobas ® 8000 modular analyzer series a 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
B-282
Figure B-171 Test Assignment window – c 701
3 Select a test in the Test list.
4 In the Test Assignment area: o Select the Mandatory check box if the reagent must be on board all the time.
o
Select the Reagent Disk A and / or the Reagent Disk B check box to assign the test to the reagent disk.
5
Choose OK .
If the cobas c pack of a mandatory test is not available on the system, the corresponding module is displayed in red on the Overview menu. Nevertheless, operation of the module can start.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 17 Utility
System Configuration submenu a 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.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure B-172 Test Assignment window – e 602
3 Select a test in the Test list.
4 Check either the Ch.1
, Ch.2
or both check boxes to assign the test to measuring channel 1, 2, or both.
5 Select the Mandatory check box if the reagents for the selected test must be available on the module all the time.
6 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.
o If the cobas e pack of a mandatory test is not available on the system, the corresponding 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.
7 Choose OK .
B-283
17 Utility
System Configuration submenu
Powering off a module
cobas ® 8000 modular analyzer series
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.
The instrument must be in Standby to activate or power off a module.
e
For more information, see: To power off a specific module on page D-15.
This is the last page of Part B.
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B-284 Operator’s Manual · Version 2.0
Operation data manager
C
18 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–3
20 Quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–43
21 Routine configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–63
22 Test configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–75
23 System configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–101
24 Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C–105
18 Introduction
Table of contents cobas ® 8000 modular analyzer series
Introduction
This chapter provides an introduction to the data manager.
Roche Diagnostics
Operator’s Manual · Version 2.0
In this chapter Chapter
18
8000 data manager and associated workflows .......................................... C-5
8000 data manager ....................................................................... C-7
8000 data manager.............................................. C-9
Shutting down and restarting the cobas
8000 data manager......................... C-9
C-3
18 Introduction
Table of contents cobas ® 8000 modular analyzer series
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C-4 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 18 Introduction
Introduction to the cobas® 8000 data manager
Introduction to the cobas® 8000 data manager
The data manager implements data and workflow management functionality and provides an interface between the cobas 8000 instrument, the LIS, and the Roche
TeleService-Net (TSN). Through TSN 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 and calibration management.
Additionally, it has LIS backup functionality and serves as a robust storage location for the instrument.
The cobas ® 8000 data manager and associated workflows
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure C-1 data manager architecture.
The data manager acts as the central point between the cobas 8000 instrument and the LIS. Therefore it is able to perform tasks that would traditionally be performed by the LIS.
Order and patient demographics entry normally take place at the LIS level. However, the data manager provides a backup to these functions when the LIS is unavailable.
Tip
The patient data stored on the data manager is limited to date of birth, gender, first and last name, and patient ID.
e
For more information see Working with samples (p. C-21).
Orders and related information are sent from the LIS to the data manager.
The instrument receives test orders from the data manager and sends the results back to the data manager.
The TeleService-Net (TSN) infrastructure provides access and routing of information and functionality to and from Roche. For example, the data manager collects the instrument’s runtime and throughput data and sends them via TSN.
The data manager serves as backup/restore medium for instrument.
Two of the main areas of work that are undertaken on the data manager are:
C-5
18 Introduction
The cobas
®
8000 data manager and associated workflows o Technical validation of test results.
o
Quality control (QC).
cobas ® 8000 modular analyzer series
Technical validation
Technical validation includes a number of tasks including checking that test result values lie within the test's technical validation range or checking if the test was performed after an out of range QC measurement.
The data manager provides full rule management, including repeats, re-runs and reflex, within a short reaction time due to the data manager’s proximity to the instrument.
The rules that can be defined on the data manager are range-based, enabling a comprehensive rule system to be defined. Depending upon how the reference ranges and rules are implemented, test results can be validated automatically (for high throughput) or manually.
e
For more information see Working with tests and reference ranges (p. C-77).
Pass-through for patient results
If necessary, technical validation can be undertaken on the LIS rather than on the data manager. In order to do this the data manager is set to pass-through for patient results mode ( cobas 8000 data manager Service workplace). In this mode all test results are forwarded to the LIS for technical validation.
It should be noted that when pass-through for patient results is operational the repeat, reflex, and re-run rule environment can still be set up on the data manager providing increased performance for repeat, reflex, and re-run tests.
The data manager can also be used as a supportive system for operative business tasks that are not provided by the instrument.
Quality control
The data manager provides full quality control management, including QC evaluation, trend analysis, monitoring, all in close proximity to the instrument.
All quality control-related tasks are performed on the data manager. Roche-related information is downloaded automatically through the TSN.
The instrument measures control samples and sends the results together with traceability information to the data manager. The data manager stores the QC results and tracks the system quality by applying Westgard rules, and provides graphical and tabular data reports of the QC measurements.
Based upon the QC evaluation, or other appropriate information, the data manager is able to undertake calibration management for the instrument.
Pass-through for QC results
If necessary, quality control can be undertaken on the LIS rather than on the data manager. In order to do this the data manager is set to pass-through for QC results
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cobas ® 8000 modular analyzer series 18 Introduction
Accessing the cobas
®
8000 data manager mode ( Service workplace). In this mode all QC-related tasks are performed on the
LIS.
The data manager can still support this activity. Monitoring and notification activities have a short reaction time when the data manager is situated close to the instrument.
Monitoring and notification functionality supports the user in performing operative tasks. A customizable warning system enables the user to make timely responses.
This can be useful when the LIS is remotely located to the instrument.
Trends critical to business operation can be evaluated and displayed on the data manager. The data manager enables you to query and filter QC data for investigations. Useful again when the LIS is remotely located to the instrument.
Pass-through for calibration results
Calibration data can also be forwarded to the LIS. In order to do this, the data manager is set to pass-through for Calibration results mode ( cobas 8000 data manager Service workplace).
Accessing the cobas ® 8000 data manager
This section explains how to start the data manager
Starting up and logging onto the data manager
You start up the data manager by powering up the data manager server. You are automatically logged into Windows. The Sidebar application opens and displays the control screen of the cobas 8000 instrument control unit.
The data manager application is accessed through the Sidebar application. Clicking the data manager window in the Sidebar displays the data manager login screen in which you enter your user name and password.
The Sidebar application
The Sidebar application enables screen sharing by providing access to the: o data manager application.
o
Control screen of the control unit of the cobas 8000 instrument.
o e-Library access screen (the data manager serves as front-end for the cobas e-
Library).
o
TraceDocViewer .
The Sidebar is located on the right side of the screen, the work area to its left contains the application that has been selected.
Access to the data manager, instrument, and e-Library is achieved by clicking on the appropriate window on the Sidebar . Clicking a window displays the corresponding application in the work area beside the Sidebar .
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Operator’s Manual · Version 2.0
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18 Introduction
Accessing the cobas
®
8000 data manager cobas ® 8000 modular analyzer series
Figure C-2
Roche Diagnostics
C-8 data manager and Sidebar
Five buttons are located at the foot of the Sidebar .
Table C-1 Sidebar buttons
TraceDocViewer
Screenshot
Issue report
Remote support status
Shut down
The TraceDocViewer is viewed by clicking the ‘magnifying glass’ button. It is displayed in the work area.
e For more information about TraceDoc and the TraceDocViewer see
The other buttons enable you to: o Make screenshots.
o
Create issue reports.
o Indicates remote support status.
o
Shut down the data manager (server).
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 18 Introduction
Accessing the cobas
®
8000 data manager
Screen capture in the cobas ® 8000 data manager
Clicking the Screenshot (camera) button on the Sidebar captures the current content of the whole screen and opens the Save Screenshot dialog box.
Tip
If you want to save the screen capture to a USB storage device, ensure that it is inserted in the USB port before clicking the ‘camera’ button.
CAUTION
You use the dialog box to determine where the screenshot is saved. By default it is saved to a dedicated directory on the data manager server. However you can also save it to a USB storage device inserted in one of the data manager server’s USB ports.
Caution a For safety reasons, you should always perform a virus scan on any USB storage device before attaching it to the data manager as the data manager is unable to perform virus scans.
Creating issue reports
CAUTION
Issue reports are generated for support purposes. The issue report comprises an annotated screenshot and the corresponding log files and system messages.
Clicking the Issue report button on the Sidebar captures the current content of the whole screen and opens the Issue Report dialog box.
Tip
If you want to save the issue report to a USB storage device, ensure that it is inserted in the
USB port before clicking the ‘camera’ button.
The dialog box contains the screenshot and a Title field in which you can give a title to the issue, and a Description field in which you can provide a description of the issue.
When you click Save on the dialog box the log files and system messages corresponding to the issue report are bundled in a zip file and saved together with the issue report.
By default issue reports are saved to a dedicated directory on the data manager server.
However you can also save them to a USB storage device inserted in one of the data manager server’s USB ports.
Caution a For safety reasons, you should always perform a virus scan on any USB storage device before attaching it to the data manager as the data manager is unable to perform virus scans.
Shutting down and restarting the cobas ® 8000 data manager
Clicking the Shut Down (door) button on the Sidebar shuts down the data manager
(server). A message is displayed asking you to confirm that you want to do this.
CAUTION
Caution a Ensure that the instrument is in Standby mode before you shut down the data manager.
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Clicking [ Shift ] together with the ‘door’ button opens the Shut down data manager dialog box. The drop-down list provides you with the following options: o Log off user o
Shutdown o Restart
Select the option you require and click OK .
It is recommended that you restart the data manager once a week. You should shut down the instrument before restarting the data manager to avoid generating an error message.
If the instrument is shut down for more than three hours, it is recommended that you also shut down data manager.
Caution a You should always reboot the data manager following a hardware failure.
CAUTION
The cobas ® 8000 data manager interface
This section explains the main interface elements of the data manager application.
K
A Title bar
B Menu bar
C Icon bar
D Information bar
Figure C-3
E Navigation tree
F Component
G Sub-component
H Work area
Main interface elements of the data manager.
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I Hide / show navigation tree & Information window bar
J Information window
K Status bar
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Default workplaces
The Title bar displays the current workplace and window title, and contains the buttons for minimizing, maximizing, and closing the application window.
The Menu bar provides access to menus with which you operate the data manager.
The Icon bar is configurable for displaying buttons that provide direct access to frequently used components and sub-components.
The Information bar provides information on the active workplace and the open element of the corresponding component. In addition, it displays the user logged.
The Navigation tree displays the components and sub-components of the current workplace in hierarchical form. Double-clicking a component displays the corresponding sub-components when they exist.
If you select a component or a sub-component in the navigation tree, the corresponding information is displayed in the work area.
The content of the Work area is determined by the component or sub-component that you selected in the navigation tree.
The Hide / show navigation tree & Information window bar enables you to enlarge the work area . Clicking the bar hides the Navigation tree and the Information window . Click the bar again to show them again.
The Information window provides configurable and concise information about the data manager.
e
For more information about the Information window see Configuring system messages
The Status bar displays the current date and time as well as the number of records in the active table.
Default workplaces
A preset group of workplaces is provided with the data manager. However if necessary, administrators can customize workplaces to suit the user.
The following is a list of the default workplaces: o cobas 8000 data manager Routine .
o cobas 8000 data manager QC Parameters .
o cobas 8000 data manager QC Routine .
o cobas 8000 data manager Routine Configuration .
o cobas 8000 data manager Test Configuration .
o cobas 8000 data manager System Configuration .
o cobas 8000 data manager Administration .
o cobas 8000 data manager Service .
The cobas 8000 data manager Routine workplace is where you undertake routine tasks, focusing on sample and test management.
There are two QC-related workplaces. You use the cobas 8000 data manager QC
Parameters workplace to maintain the parameters used in the quality checks according to quality control rules. The cobas 8000 data manager QC Routine workplace is where you monitor quality checks and manage, view, and evaluate control values when errors have occurred.
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Standard tasks
CAUTION
There are three configuration workplaces. You maintain the parameters used in routine work using the cobas 8000 data manager Routine Configuration workplace. The cobas 8000 data manager Test Configuration workplace is used to maintain test-related parameters, and the cobas 8000 data manager System
Configuration workplace to maintain system-related parameters.
You use the cobas 8000 data manager Administration workplace to configure how the system is used in terms of workplace access and user rights.
The cobas 8000 data manager Service workplace is used primarily by Service
Engineers, however it is accessible to anyone with the appropriate access rights.
Caution a The structure of the data manager section of the manual reflects the default data manager workplaces. In addition, the procedures described start by indicating in which part of the data manager the procedure is undertaken. a For example, cobas 8000 data manager Test Configuration > Formulas > List indicates that the procedure takes place in the List sub component of the Formulas component in the cobas 8000 data manager Test Configuration workplace. a Be aware that by re-arranging data manager workplaces and components, it may make it difficult to locate the procedures in the data manager section of the manual.
Standard tasks
Selecting a workplace
The data manager section of the manual describes routine tasks according to common laboratory practices. The following describes the most important standard tasks that may be used.
The Workplaces menu on the menu bar is available for you to select workplaces. The contents are user-dependent, which means that the menu contains only those workplaces that have been assigned to you.
e For more information about workplaces see
Selecting components and sub-components
The Navigation tree is where you select components and sub-components . The contents of the tree depend on the workplace that you selected from the Workplaces menu.
Clicking a component displays the corresponding information in the work area.
When a component has sub-components, you can display them by double-clicking the component. To hide sub-components, double-click the component to which they belong.
Clicking a sub-component displays the corresponding information in the work area.
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Standard tasks
Tip
To ensure that the most current components and sub-components are displayed, rightclick on the Navigation tree , and then on the shortcut menu click Reload tree . The
Navigation tree refreshes.
Searching for data
There are a number of different ways by which you search for data on the data manager.
Filters
Filters are available in a number of components (e.g. the Sample overview , Day list , and Technical validation components in the cobas 8000 data manager Routine workplace) with which you can search for data by entering the appropriate criteria.
Search criteria dialog box
The Day list and Technical validation components in the cobas 8000 data manager
Routine workplace provide you with an additional search facility.
Right-click in the samples table ( Day list ) or the tests table ( Technical validation ), and then click Edit search criteria (F7) on the shortcut menu. The Search criteria dialog box opens.
Tip
You can also open the Search criteria dialog box by pressing [F7].
You then enter / select the appropriate search criteria.
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Figure C-4 Search criteria dialog box.
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Standard tasks cobas ® 8000 modular analyzer series
As with any search that you perform, the more criteria that you enter, the more refined the search results.
After selecting the search criteria you click Apply . The Search criteria dialog box closes and the data matching your search criteria is displayed in the table.
Wild card searches
In text boxes you can use wild cards to select certain kinds of data. For example, all names starting with ‘B’ or all numbers containing the string ‘234’.
The character ‘ % ’ stands for any number of characters, and the character ‘ _ ’ for a single character.
Examples:
You enter
D d
%5
%5%
_5
The system finds all entries
...beginning with a capital D.
...beginning with a lower case d.
... that end with a 5.
... that contain a 5.
... consisting of two characters and the second character is 5.
eLibrary document searches
There are three ways of searching for eLibrary documents within the data manager: o HRD search.
o Show eLibrary document about application .
o Show eLibrary document about control .
The HRD (Human Readable Documents) search function enables you to view eLibrary documents from anywhere in the data manager.
You perform HRD searches by clicking HRD search on the data manager Help menu. The HRD search dialog box opens.
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Working with tables
18 Introduction
Standard tasks
C
D
You enter the appropriate search criteria and click Search . Documents matching your search criteria are listed in the table below the search criteria.
To open a document in the Document Viewer you double-click its entry in the table.
Show eLibrary document about application is a shortcut menu item available in the following components: o Sample overview e
o Day list e
o Technical validation e
o QC Routine e
See The QC Routine component (p. C-57)
Right clicking on a test in these components and then clicking Show eLibrary document about application on the shortcut menu opens a submenu containing all eLibrary documents associated with the test.
Clicking on an entry on the submenu opens corresponding the document in the
Document Viewer .
A
B right-click on a control in the QC Routine component.
Show eLibrary document about control provides the same functionality when you
Tables in the data manager enable you to select and view data in different ways.
G
E
F
A Column
B Column header
C Column used to group by.
D Group heading
Figure C-6 Table elements
E Row
F Show/hide group
G Grouping bar
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Simple sorting
A simple way to sort data in a table is by clicking the column header by which you want to sort. The sort arrow on the column header points downwards to indicate that the values are listed in descending order, and points upwards to indicate an ascending order.
Text entries are sorted alphabetically, and numbers numerically.
Group sorting
You can group table contents by column entries (e.g. by patient). Left-click the column header by which you want to group and, holding down the mouse button, drag the column header to the Grouping bar
(Figure C-6 Table elements (p. C-15))
and then release the mouse button.
The table divides into groups each headed by an entry from the column by which you are sorting. Each group is sorted accordingly. For example, if you sorted using the
Patient column header , the table would be divided into groups where each group is headed by a patient. Each group would contain the corresponding table data (rows) for each patient.
You can perform more complex group sorts by dragging a second column header to the Grouping bar . This will perform a further sort on the groups.
Table groups can be hidden by clicking the ‘ ’ button to the left of group header, and made visible again by clicking the ‘ + ’ button.
To remove the groupings, right-click in the table, and then click Reset table settings on the shortcut menu. The column header(s) used to group are returned to their original position(s).
Selecting table rows
You can select a single row by clicking it.
To select adjacent rows, click the first row that you want to select. Press the [ Shift ] key and click the last row in the group that you want to select. The adjacent rows are selected.
To select a number of non-adjacent rows, click the first row that you want to select.
Press the [ Ctrl ] key and while it is depressed, click the additional rows want that you want to select.
Showing and hiding table columns
For any table, you can define which columns are displayed. Right-click anywhere in the table, and then click Properties on the shortcut menu. The Properties dialog box opens.
The Properties dialog box contains a list of the columns which can be displayed in the table. Each column has a check box. When the check box is selected the column is displayed in the table. When the check box is deselected the column is not displayed.
You can determine the columns which are displayed in the table by selecting and deselecting the corresponding check boxes.
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Standard tasks
Exporting and printing tables
CAUTION
By right-clicking in a table, and then clicking Export table to...
on the shortcut menu a sub menu opens on which you can click either Excel file...
or Printer...
.
If you click Excel file...
the Save to Excel dialog box opens with which you can save the table in MS Excel format.
The file is saved to a dedicated directory on the data manager server. To access the file you must log off as the user and a user with administrator rights must log on. They can then copy the file to a USB storage device in the Windows Explorer.
You can then process the Excel spreadsheet on any other computer.
Caution a For safety reasons, you should always perform a virus scan on any USB storage device before attaching it to the data manager as the data manager is unable to perform virus scans.
If you click Printer...
the Print dialog box opens with which you can print the table to the selected printer.
Refreshing table data
Online help
and then click Reload table on the shortcut menu. The table is updated.
To ensure that the most up-to-date data is displayed in a table right-click in the table,
The data manager application provides online help for every window and dialog box.
The online help opens in a dedicated window.
You display online help in context by pressing [F1].
Selecting DM help on the Help menu opens the online help at its table of contents.
Additionally, the online help provides an index, and search and bookmarking functionality.
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Routine tasks
19 Routine tasks
Table of contents
This chapter contains step-by-step descriptions of the procedures undertaken on a daily basis using the data manager cobas 8000 data manager Routine workplace.
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19
Requesting additional tests (Technical validation component)......................... C-31
Validating test results manually using the information window ....................... C-35
Validating test results manually in the Technical validation component ........ C-36
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Working with samples
Working with samples
The data manager enables you to register samples and administrate their associated data.
Samples in the data manager have two possible sources. They are: o Transferred from the LIS o
Manually entered in the data manager.
Samples from the LIS are listed and can be viewed in the Day list and the Sample overview components of the cobas 8000 data manager Routine workplace. This is the normal way for samples to be viewed in the data manager.
When the LIS is unavailable, samples can be entered manually using the LIS Backup component of the cobas 8000 data manager QC Routine workplace.
Much of the initial sample administration takes place in the cobas 8000 data manager QC Routine workplace. This section considers the day to day administration of samples in the data manager: o
Registering a sample.
o Viewing samples.
o
Adding tests to, and deleting tests from a sample.
o Commenting on a sample.
Registering a sample manually
The data manager retains data transferred from the LIS for a pre-determined period of time.
You can use the LIS Backup to manually register samples when the LIS is unavailable.
If a sample has not been transferred from the LIS automatically you can register it manually in the LIS Backup component of the cobas 8000 data manager Routine workplace.
There are three main steps to registering a sample manually: o Entering the sample details.
o
Assigning a patient ID to the sample.
o Adding tests to the sample.
Tip
New patients cannot be entered on the data manager. You can only select patients that already exist (i.e. were created on the LIS).
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Figure C-7 LIS backup component
To register a sample manually: a cobas 8000 data manager Routine > LIS Backup
1 In the sample group box, enter the appropriate sample data.
Tip o If by mistake, you enter blank spaces (‘white space’) before or after the Sample ID characters, they will be removed automatically when you save the sample.
o The Cup type defaults to Normal and the Order d/t and Collection d/t default to the current day’s date and time.
2 To assign a patient to the sample, click Search patient . The Search patient dialog box opens.
3 Enter the appropriate search criteria and click Apply . Patients matching your search criteria are listed in the patients table.
4 Double-click the patient you wish to assign to the sample. The Search patient dialog box closes and the patient details are entered in the patient group box.
5 Select the Pre-dilution check box if the sample is pre-diluted.
6 Click Apply .
7 From the Test drop-down list, select a test and press [Enter] . Repeat this procedure for each of the tests that you require. The test selections are saved automatically.
8 If appropriate, add a comment to the sample you are creating. The test selections are saved automatically.
e
For more information see Adding a comment to a sample (p. C-27)
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Viewing samples
19 Routine tasks
Working with samples
You can view samples and their associated information in the Sample overview and the Day list components of the cobas 8000 data manager Routine workplace.
The Sample overview component provides search criteria with which you can view samples. This includes searching by Sample ID meaning it provides a quick way of locating individual samples.
The Day list component provides filters with which you can search and view samples. Additional search criteria are available by using the Search criteria dialog box.
Sample overview
The Sample overview component enables you to search for samples based on sample-related criteria (located at the top of the work area): o Sample ID .
o
Orders from / To .
o Priority .
o
Sample type .
and by patient(s).
It contains three tables: o o
Samples table (located below the search criteria): contains samples matching the search criteria.
Targets table (located bottom left): contains instruments associated with the selected sample.
o
Tests table (located bottom right): contains tests associated with the selected sample.
Figure C-8 Sample overview component
To view samples and their associated information in the Sample overview component:
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Working with samples
Day list cobas ® 8000 modular analyzer series a cobas 8000 data manager Routine > Sample overview
1 Enter the appropriate search criteria in the sample group box and the patient group box.
For example, to view all emergency samples, from the Priority drop-down list, select STAT .
Tip
The Orders from and To dates default to the current day and should be modified appropriately to view samples ordered from earlier dates.
2 Click Apply . The samples matching your search criteria are listed in the samples table below the search criteria.
3 To view associated information, in the samples table click the sample whose information you wish to view. The instruments associated with the sample are listed in the targets table (bottom left).
4 To view the tests associated with an instrument, in the targets table click the instrument. The associated tests are displayed in the tests table (right).
Tip
When you select a sample, the tests associated with the first instrument in the targets table are listed in the tests table.
The Day list enables you to view all samples for the current day, or all samples for the current day according to their status: o Results pending (sample has tests without results).
o Validation pending (all sample tests have results and are awaiting validation).
o Completed samples (all sample tests are validated).
It contains four tables: o Samples table (located below the search criteria): contains samples matching the filter criteria.
o Tests table (located below the samples table): contains tests associated with the selected sample.
o Sample comments table (located bottom left): contains comments associated with the selected sample.
o Test comments table (located bottom right): contains comments associated with the selected test.
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Working with samples
Figure C-9 Day list component
To view samples and their associated information in the Day list component: a cobas 8000 data manager Routine > Day list
1 Select the samples filter check box that best matches the samples you wish to view.
The corresponding samples are listed in the samples table beneath the samples filters.
Tip
Additional search criteria are available by using the Search criteria dialog box (press
[ F7 ].
2 To view information associated with a sample, in the samples table click the sample whose information you wish to view.
The tests associated with the sample are listed in the tests table below the samples table.
Comments associated with the sample are listed in the sample comments table
(bottom left).
3 Click on a test in the tests table to display associated comments in the test comments table (bottom right).
Requesting additional tests for a sample
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Depending upon the context of your work, you can add tests to a registered sample in the following Routine workplace components: o Sample overview .
o Day list .
o Technical validation .
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Working with samples cobas ® 8000 modular analyzer series
In the Sample overview and the Day list components you locate the sample to which you wish to add a test(s) and then add the test.
e For information on adding tests in the Technical validation
component see Requesting additional tests (Technical validation component) (p. C-31).
To add one or more tests to a sample in the Sample overview and the Day list components: a cobas 8000 data manager Routine > Sample overview / Day list
1
Locate and click the sample to which you wish to add a test.
e For more information on locating samples in the Sample overview and the Day list components see
2
In the Sample overview component, in the instruments table select the instrument to which the test is to be added. The existing tests are displayed in the tests table.
In the Day list component the existing tests are displayed in the tests table when you select the sample.
3
In each case, right-click in the tests table, and then click Request additional test on the shortcut menu. The Edit sample dialog box opens.
4
From the Test drop-down list in the Test selection group box, select the test you want to add to the sample.
5
Press [Enter] . The test is added to the tests table.
6
Repeat steps 4 and 5 to request additional tests.
7
Click Cancel to close the Edit sample dialog box. The test(s) are added to sample.
Deleting a test from a sample
If you have the appropriate rights, you can delete tests from a registered sample in the: o Sample overview component.
o
Day list component.
The procedure is fundamentally the same in each. Tests with any status can be deleted.
To delete a test from a sample: a cobas 8000 data manager Routine > Sample overview / Day list
1 Locate and select the sample with which the test that you want to delete is associated.
2 In the tests table, right-click the test you want to delete, and then click Delete test on the shortcut menu. A message box opens prompting you to confirm you want to delete the test.
3 Click OK to confirm. The test is removed from the corresponding tests table.
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Adding a comment to a sample
You can add comments to a sample in each of the following Routine workplace components: o LIS Backup .
o
Sample overview .
o Day list .
The comments that you add to a sample can be pre-configured or free text. The preconfigured comments have been assigned to the sample.
e
For more information about assigning comments see Managing comment texts (p. C-98).
To add a comment to a sample: a cobas 8000 data manager Routine > LIS Backup / Sample overview / Day list
1
In the Sample overview and Day list components, locate the sample to which you want to add a comment.
e For information about locating a sample in:
Sample overview
Day list see
In the LIS Backup component you add the comment as you create a sample.
e For information abut creating a sample in LIS Backup
see Registering a sample manually (p. C-21).
2
In the Sample overview and Day list components, right-click the sample to which you are adding a comment, and then click Insert sample comment on the shortcut menu.
In the LIS Backup component, click Comment .
In each case the Sample comment dialog box opens.
3
You can select pre-configured comments by using the Code or the Text dropdown lists. Additionally you can enter a comment as free text, or supplement a comment in Comment text : a)Select the comment you require on the Code or Text drop-down lists and click
Apply . The corresponding comment text is entered in Comment text .
Tip
The Code and Text drop-down lists contain the same comments. The Code dropdown list orders comments by code. The Text drop-down list orders the comments alphabetically.
b)Enter comments as free text directly in Comment text as necessary.
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4 Clicking Apply adds the comment to the comments table and leaves the dialog box open for further comments to be added.
Clicking OK adds the comment to the comments table and closes the dialog box.
Tip
To edit a comment, double-click the comment in the comments table. The comment is displayed in Comment text in which you can modify it.
To delete a comment, in the comments table right-click the comment you want to delete, and then click Delete comment on the shortcut menu.
Working with tests
The data manager enables you to view tests and test result data.
Although you can work with samples and their corresponding tests in the Sample overview and Day list components, the Technical validation component provides a more direct access to tests.
This section looks at the main procedures that you undertake with tests: o Viewing tests.
o Searching for tests.
o Viewing a test’s details.
o Adding comments to tests.
o Requesting additional tests.
o Deleting tests.
o Entering test results.
o Repeating a test.
o Requesting a dilution for a test.
Viewing tests
The Technical validation component provides you with the most direct way to view tests and their associated information. It provides filters enabling you to view all tests or to view tests based on their status: o Pending results.
o
Pending validation.
o Processed tests.
and the time period since they were requested.
It contains three tables: o Tests table (located below the filters): contains tests matching the filter criteria.
o
Sample comments table (located bottom left): contains comments associated with the sample of the selected test.
o Test comments table (located bottom right): contains comments associated with the selected test.
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Working with tests
Tip
You can also view tests in the Sample overview and Day list components, but do this on a sample basis.
e
For more information see Sample overview (p. C-23) and
You can further filter the tests that you are viewing by using the column heads of the tests table. For example, you might want to view emergency tests: by dragging-anddropping the Priority column head above the tests table, you group the tests by their priority and all emergency tests are grouped together.
Figure C-10 Technical validation component
The Information window also provides you with a direct means of viewing tests.
e For examples of using Information windows see
Validating test results manually (p. C-34).
To view tests and their associated information: a cobas 8000 data manager Routine > Technical validation
1 Select the test filter that best matches the tests you wish to view. The corresponding tests are listed in the tests table beneath the tests filters.
Tip
The test filters apply the current day’s date by default. You can change date range applied using the Search criteria dialog box.
e For information about using the
Search criteria
dialog box see Searching for tests
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2 To view information associated with a test, in the tests table click the test whose information you wish to view.
Comments associated with the sample of the selected test are listed in the sample comments table (bottom left).
Comments associated with the selected test are listed in the test comments table
(bottom right).
Searching for tests
In addition to viewing tests using the Technical validation component’s test filters, you can search for tests using the Search criteria dialog box. It provides you with test-specific (and sample) search criteria with which you can search for tests.
The Search criteria dialog box applies the search criteria to the tests that have been returned by a test filter.
To search for tests: a cobas 8000 data manager Routine > Technical validation
1 Select the Pending results check box. All tests are listed in the tests table beneath the filters.
2 Right-click the tests table, and then click Edit search criteria (F7) on the shortcut menu. The Search criteria dialog box opens.
3 Type in the appropriate search criteria.
4 Click Apply . The Search criteria dialog box closes and the tests corresponding to your search criteria are listed in the tests table.
Viewing test details
You can view the details of a test using the Show test details command on the shortcut menu. It provides comprehensive information about the test, including: o
Sample ID, test selection date and time, and patient name.
o Test type and unit.
o
Test reference ranges.
o Test results and associated data.
o
Quality control data.
To view test details:
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Working with tests a cobas 8000 data manager Routine > Technical validation
1 Locate and right-click the test whose details you wish to view, and then click
Show test details on the shortcut menu. The Test details dialog box opens containing information about the test.
Confidential result
If the test that you are viewing is flagged Confidential result , you can only see the result if you have been assigned Read confidential results user rights. If you have not been assigned these rights the test result will appear as ‘xxxxx’.
2 Click the Additional data tab to view the test’s QC data.
3 Click Close to close the dialog box.
Requesting additional tests (Technical validation component)
In the Sample overview and Day list components you specify the sample for which you want to request additional tests.
In the Technical validation component you must specify a test that is associated to the sample to which you want to request additional tests.
To request additional tests: a cobas 8000 data manager Routine > Technical validation
1 Locate and right-click a test associated with the sample for which you wish to request additional tests, and then click Request additional test on the shortcut menu. The Edit sample dialog box opens.
2 On the Test drop-down list in the Test selection group box, select the test you want to add to the sample.
3 Press [Enter] . The test is added to the tests table in the dialog box.
4
Repeat steps 2 and 3 to request additional tests.
5 Click Cancel to close the Edit sample dialog box. The test(s) are added to the sample.
Deleting a test
To delete a test: a cobas 8000 data manager Routine > Technical validation
1
Locate and right-click the test you want to delete, and then click Delete test on the shortcut menu. A message box opens prompting you to confirm you want to delete the test.
2
Click OK to confirm. The test is removed from the tests table.
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Adding comments to a test
You can add pre-configured and free text comments to a test.
This procedure describes how you can add a comment to a test in the Technical validation component. You use the same procedure add a comment to a test in the
Sample overview and Day list components.
To add a comment to a test: a cobas 8000 data manager Routine > Technical validation
1
Locate and right-click the test to which you want to add a comment, and then click Insert test comment on the shortcut menu. The Test comment dialog box opens.
2
You can select pre-configured comments by using the Code or the Text dropdown lists. Additionally you can enter a comment as free text, or supplement a comment in Comment text : o
Select the comment you require on the Code or Text drop-down lists and click Apply . The corresponding comment text is entered in Comment text .
Tip
The Code and Text drop-down lists contain the same comments. The Code dropdown list orders comments by code.The Text drop-down list orders the comments alphabetically.
e
For information on setting up comments Managing comment texts (p. C-98)
o Enter comments as free text directly in Comment text as necessary.
3 Clicking Apply adds the comment to the comments table and leaves the dialog box open to make further comments.
Clicking OK adds the comment to the comments table and closes the dialog box.
Tip
To edit a comment, double-click the comment in the comments table. The comment is displayed in Comment text in which you can modify it.
To delete a comment, in the comments table, right-click the comment you want to delete, and then click Delete comment on the shortcut menu.
Entering a test result manually
Test results are normally entered automatically. When necessary you can enter or reenter test results manually. Test results can be entered in the Sample overview , Day list , and Technical validation components.
For tests that are flagged Confidential result
Note that manually entered values are not validated automatically and require manual validation.
You cannot modify validated results. You must repeat the test.
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Working with tests
If a test is flagged Confidential result , you can only enter a result manually when you have been assigned Read confidential results user rights. If you try to enter a result without the user right assigned, an error message is displayed saying that you are not authorized to do so.
e
For more information see Working with tests and reference ranges (p. C-77)
After the result has been entered the status of the test changes to In release .
It is possible to configure test result values to be color-coded. For example, red to indicate the result is out of range, and green to indicate the result is within range.
Caution a Ensure that test results are entered accurately. Inaccurately entered results could lead to an incorrect treatment of the patient.
a Test result values must be entered in line with the regional settings. Failure to do so will make the result unrecognizable as a value. For example, if the decimal separator is set to a comma (‘ , ’) by the regional settings, a full stop/period (‘ .
’) will invalidate the result if used as a decimal separator.
To enter or re-enter test results manually: a cobas 8000 data manager Routine > Sample overview / Day list /
Technical validation
1 Locate and click the test for which you want to add the test result.
2 Press [Enter] . The Result entry dialog box opens.
3 In Result , type in the numeric or alphanumeric value of the test result.
4 Press [Enter] . The Result entry dialog box closes and the result is entered.
Repeating a test
You can repeat a test before or after technical validation. You cannot repeat tests awaiting results. Tests can be repeated using the Sample overview , Day list , and
Technical validation components.
To repeat a test: a cobas 8000 data manager Routine > Sample overview / Day list /
Technical validation
1 Locate and right-click the test that you want to re-run, and then click Repeat test on the shortcut menu.
Tip
In the Day list and Technical validation components, selecting the Pending validation or the Processed tests check box will list tests that can be repeated.
2
The test can be repeated and as such will be listed when selecting the Pending validation check box.
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Validating test results manually
Requesting a dilution for a test
It might be necessary for you to request a dilution of a test either before or after you re-run a test. Dilution requests can be made from the Sample overview , Day list , and
Technical validation components.
You are able to request that the dilution factor for a test be increased or decreased.
To request a dilution for a test: a cobas 8000 data manager Routine > Sample overview / Day list /
Technical validation
1
In the tests table, locate and right-click the test for which you want to request a dilution, and then click Request dilution on the shortcut menu. The Request dilution for test: dialog box opens.
2
From the Dilution factor drop-down list click Decreased or Increased to request that the dilution factor be increased or decreased.
3
Click OK . The test result value is removed and the requested increase or decrease is indicated in the corresponding Requested dilution column of the table.
Additionally, the corresponding Repeat check box shows as selected in the
Sample overview and the Day list components, and the corresponding Multiple results check box shows as selected in the Technical validation component.
Validating test results manually
Depending upon how you have configured test validation rules and ranges, the majority of test results can be technically validated automatically.
e
For more information see Working with tests and reference ranges (p. C-77).
Test results must be validated manually in the following situations: o A test result falls outside the test’s technical validation range.
o
A test has not been flagged for automatic validation.
o An instrument flag has been set to block automatic validation.
o
Test results which have been entered manually.
You can manually validate test results: o
Individually ( Technical validation , Day list and Sample overview components).
o By sample ( Day list component).
There are three main locations in the data manager where you can manually validate tests: o Information window : Tests pending tech val (STAT) and Tests pending tech. validation (ROUTINE) .
o
Technical validation component: selecting the Pending validation check box lists all tests awaiting technical validation.
o Day list component: to validate test results by sample.
It is also possible to validate tests individually in the Sample overview component.
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Validating test results manually
Caution a Only authorized laboratory personnel should technically validate test results.
CAUTION
Validating test results manually using the information window
The information window provides you with direct access to test results awaiting technical validation. There are two system messages that you can use: o Tests pending tech. validation (ROUTINE) o
Tests pending tech val (STAT)
Each message indicates the number of test results awaiting technical validation.
In each case, double-clicking the message opens a dialog box containing the
Technical validation component, and in which the Pending validation check box is selected and the test status is In release .
The tests in the Tests pending tech val (STAT) system message have the status
‘ STAT ’ and the tests in the Tests pending tech. validation (ROUTINE) system message have the status ‘ Routine ’.
The process of validating test results in either information window is the same.
Validated tests can be viewed in the Technical validation component with the
Processed tests filter applied. The check box in the Validated column is selected, indicating that the test result has been technically validated.
To validate test results using an information window: a Information window > Tests pending tech val (STAT) / Tests pending tech. validation (ROUTINE)
1 Double-click the Tests pending tech val (STAT) / Tests pending tech. validation (ROUTINE) system message. In each case the Technical validation -
STAT / Technical validation - ROUTINE dialog box opens containing test results awaiting validation.
2 In the tests table right-click the test that you want to validate, and then click
Validate test result (F8) on the shortcut menu.
Tip
You can also validate selected tests by pressing [F8] .
The test is technically validated and it disappears from the tests table of the
Technical validation - ROUTINE or Technical validation - STAT dialog box.
3
Repeat the procedure for any other tests you want to technically validate, and close the dialog box.
Tip
You can validate more than one test at once by first making a multiple selection.
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Validating test results manually in the Technical validation component
You can validate test results using the Technical validation component and applying the Pending validation filter.
Tip
You can also validate test results in the Day list and Sample overview components using the same procedure. The main difference is that you must first select a sample in order to view and validate the test results.
Validated tests can be viewed in the Technical validation component with the
Processed tests filter applied. The check box in the Validated column is selected, indicating that the test result has been technically validated.
To validate test results in the Technical validation component: a cobas 8000 data manager Routine > Technical validation
1 Select the Pending validation check box. All tests awaiting technical validation are listed in the tests table.
2 Right-click the test that you want to validate, and then click Validate test result
(F8) on the shortcut menu.
Tip
You can also validate selected tests by pressing [F8] .
The test is technically validated and it disappears from the tests table.
3 Repeat the procedure for any other tests you want to technically validate, and close the dialog box.
Tip
You can validate more than one test at once by first making a multiple selection.
Validating test results manually by sample
You can validate tests by validating the sample to which they belong using the Day list component and applying the Pending validation filter. In this case only samples where all tests have results are displayed.
To validate test results by sample: a cobas 8000 data manager Routine > Day list
1 Select the Validation pending check box. All samples awaiting technical validation are listed in the samples table.
2 Right-click the sample that you want to validate, and then click Validate all sample results (F8) on the shortcut menu.
Tip
You can also validate test results for the selected sample by pressing [F8] .
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Results reporting
The sample results are technically validated and the disappears from the samples table.
Results reporting
You can generate test results reports in the Technical validation component. You have the option to preview a report before printing it, or printing it directly.
Tip
You can configure the data manager to print reports automatically (i.e. without using print commands) by entering the appropriate information on the Autoprint tab of the System configuration component, in the cobas 8000 data manager System Configuration workplace.
Show result report
The Show result report command enables you to preview a test result report and to print it.
a cobas 8000 data manager Routine > Technical validation
1 Locate and right-click the test whose results you wish to view, and then click
Show result report on the shortcut menu.
If there are two units, a sub-menu on which you must select Single result report or Single result report (two units) . The print preview window opens in which you can view the report.
2 To print the report click the printer icon on the tool bar of the print preview window.
Print result report
The Print result report command prints a test result report directly from the tests table.
a cobas 8000 data manager Routine > Technical validation
1
Locate and right-click the test whose results you wish to view, and then click Print result report on the shortcut menu.
If there are two units, a sub-menu on which you must select Single result report or Single result report (two units) .
The report is sent directly to the printer.
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Masking and unmasking tests
Masking and unmasking tests
When a test is masked it is blocked from being used by the instrument to which it is assigned. Tests can be patient masked or test masked
The Test mask overview component provides you with information about test masking.
Tip
Test masking is bi-directional. Tests masked on the instrument will be reflected in the Test mask overview .
Masking a test on the data manager is only possible when the Control Unit is running.
It enables you to request test or patient masking, and unmasking by: o Instrument.
o Module.
o Sub-module.
o Masking profile.
o Individual test.
Tip
Masking profiles are created in the cobas 8000 data manager Routine Configuration workplace using the Mask profiles component.
e
For more information see Defining an instrument masking profiles (p. C-69)
Tests are color-coded to indicate their masking status: o Violet : test masking.
o Orange : patient masking.
o Gray : module masking.
o No color (white) : unmasked.
The Test mask overview component also enables you to view the masking history of tests.
The number of masked tests is indicated by the Masked tests message in the
Information window . Opening the message displays the Test mask overview as a dialog box and provides the same functionality.
Masking and unmasking tests by instrument
To mask or unmask tests by instrument: a cobas 8000 data manager Routine > Test mask overview
1 On the Mask test tab, click the check box beside the instrument, module or submodule containing the tests you wish to mask.
The Confirm masking message box opens.
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Masking and unmasking tests
2 Click one of the following: o Patient masking to apply patient masking to the tests.
or, o
Test masking to apply test masking to the tests.
or, o Unmask to remove masking from tests.
The request to mask or unmask the tests is sent to instrument.
If you were masking tests, the check box beside the instrument, module or submodule, and all of the corresponding test check boxes are selected.
If you were unmasking tests, the corresponding instrument, module or submodule, and test check boxes are de-selected.
The tests are color-coded indicating their masking status.
Masking and unmasking tests by mask profile
To mask or unmask tests by mask profile: a cobas 8000 data manager Routine > Test mask overview
1 Click the Masking profiles tab.
The masking profiles are displayed.
2 Click the check box beside the masking profile that you wish to use.
The Confirm masking message box opens.
3 Click one of the following: o Patient masking to apply patient masking to the tests.
or, o
Test masking to apply test masking to the tests.
or, o Unmask to remove masking from tests.
The request to mask or unmask the tests is sent to instrument.
If you were masking tests, the check box beside the masking profile, and all of the corresponding test check boxes are selected.
If you were unmasking tests, the masking profile check box and the corresponding test check boxes are de-selected.
The masked tests are color-coded indicating their masking status.
Masking and unmasking individual tests
To mask / unmask an individual test:
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System information cobas ® 8000 modular analyzer series a cobas 8000 data manager Routine > Test mask overview
1 Locate the test that you want to mask and either: o Click its check box.
or, o
Right click the test and on the shortcut menu select Request patient masking or test masking .
In each case the Confirm masking message box opens.
Tip
Clicking the instrument name ( Mask test tab) will display all available tests.
2 Click one of the following: o Patient masking to apply patient masking to the tests.
or, o Test masking to apply test masking to the tests.
or, o Unmask to remove masking from tests.
The request to mask or unmask the tests is sent to instrument.
If you were masking the test, its check box is selected and it is color-coded accordingly. Orange if patient-masked tests, and grey if test-masked.
If you were unmasking a test, the test check box is de-selected and the colorcoding is removed.
Viewing the masking history of a test
To view the masking history of a test: a cobas 8000 data manager Routine > Test mask overview
1 Locate the test whose masking history you wish to view.
The masking history of the test is displayed in the bottom table.
System information
In the cobas 8000 data manager Routine workplace you are able to view system statuses and system alarms.
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Reviewing system statuses
The System status component enables you to review pre-defined system statuses together with the corresponding system alarms.
To review a system status: a cobas 8000 data manager Routine > System status
1
In the navigation tree, click the system (data manager or an instrument) whose statuses you want to view.
2
Use Status date to select the date for which you want to view statuses.
The corresponding statuses are listed in the statuses table.
3
In the statuses table, click on the status that you want to view.
The corresponding alarms are listed in the alarms table below.
4
To view the details of a status, right-click the status, and then click Display status on the shortcut menu.
The System status dialog box opens, containing the status details.
5
Close the dialog box after reviewing the status details.
6
To view details of an alarm associated with the selected status, in the alarms table right-click the alarm, and then click Display alarm on the shortcut menu.
The System alarm dialog box opens, containing the alarm details.
7
Close the dialog box after reviewing the details.
Reviewing system alarms
The System alarms component lists alarms with and without a corresponding system status. System alarms indicate when there are errors in the system.
To view a system alarm: a cobas 8000 data manager Routine > System alarms
1
In the navigation tree, click the data manager or an associated instrument to review the corresponding alarms.
2
Use Alarm date to select the date for which you want to view alarms.
The alarms are listed in the alarms table.
3
In the alarms table, right-click the alarm whose details you want to review, and then click Display alarm on the shortcut menu. The System alarm dialog box opens, containing the alarm details.
4
Review the details and close the dialog box.
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20 Quality control
Table of contents cobas ® 8000 modular analyzer series
Quality control
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Operator’s Manual · Version 2.0
Quality control is undertaken in two workplaces in the data manager. You use the cobas 8000 data manager QC Parameters workplace to configure the data manager for quality control, and the cobas 8000 data manager QC Routine workplace to retrieve and evaluate the results of the quality control test.
In this chapter Chapter
20
Viewing and printing control material and instrument assignment reports ... C-48
Westgard rules - instrument test assignment ................................................. C-53
Working with QC calibration and QC violation.................................................. C-54
Managing calibration recommendations ........................................................ C-56
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QC Parameter
QC Parameter
You use the cobas 8000 data manager QC Parameters workplace to: o Manage control materials.
o
Create and assign Westgard rules.
o Set the QC configuration.
o
Work with calibration settings.
Each of these activities is explained in the following sections.
Managing control materials
A control material is a sample with known target values used to carry out the assigned
QC tests on an instrument. The Control material component is used to manage control materials.
The Control material component contains filters at the top of the work area and three sets of tabbed tables.
The filters enable you to search for control materials. The tabbed tables are used to view, edit and create control materials.
The overview tab tables contain the results of a filter, and can be used to create controls. The three tabbed tables are linked hierarchically. Selecting a control in the table on the Control overview tab displays the associated lots in the table on the Lot overview tab. Selecting a lot displays the associated instrument / tests in the table on the Instrument overview tab.
The Detail tabs contain the details of the corresponding control material / lot / test selected on the overview tabs. They can be used for editing purposes.
Figure C-11 Control material component
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Roche control material information is downloaded to the data manager automatically by cobasLink via the instrument.
Non-Roche control materials must be created using the data manager.
Editing a Roche control material
With Roche control materials, the Lock validation and the Release automatically options are not downloaded to the data manager. You must set these options as necessary.
You can set the Lock validation at a lot level or at an individual test level. When selected, if a control fails quality control, all related patient results are not released.
When it is not selected, related patient results are released when a control fails quality control.
When Release automatically is selected, a locked test is automatically released when its control result fulfills all defined Westgard rules. When it is not selected you must release the locked test manually.
The values of a Roche control material are automatically updated. Consequently the values cannot be changed manually (i.e. they are grayed out). However, if you need to change the Target value and the Std. deviation values of a control, selecting Use custom values on the control Detail tab enables you to manually update them.
As long as Use custom values remains selected the Target value and the Std. deviation values will not be updated automatically.
If you de-select Use custom values a message is displayed asking you if ‘you want to use the instrument-specific target values and overwrite the current ones’. If you say
‘Yes’, the Target value and the Std. deviation values revert to the downloaded Roche values, and the fields revert to being un-editable (grayed out).
To edit a Roche control material: a cobas 8000 data manager QC Parameters > Control material
1
Use the filters at the top of the work area to select the control material that you want to edit. The control material matching your filter criteria is listed in the
Control overview table. The lots associated with the selected control materials are listed in the Lot overview table.
2
To select (or deselect) the Lock validation option at lot level: o
In the Lot overview table, click the lot you wish to edit. o Click the lot Detail tab and select (or deselect) the Lock validation check box.
o
Click Apply .
Tip
To select (or deselect) the Lock validation option at lot level for other lots associated with the control material, you can display the lots sequentially using >> (next lot) and
<< (previous lot) rather than using the tabs.
3
To select (or deselect) Release automatically or to select (or deselect) Lock validation at test level, in the Instrument overview table, right-click the
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QC Parameter appropriate test, and then click the corresponding command on the shortcut menu: o Click Release automatically y/n to select or deselect the Released automatically check box.
o
Click Lock validation y/n to select or deselect the Validation locked check box.
In each case, the respective statuses are indicated by the corresponding check boxes in the Released automatically and Validation locked columns of the
Instrument overview table.
Tip
You can also select (or deselect) the Release automatically and Lock validation check boxes on the test’s Detail tab. As with lots, you can display the tests sequentially using >> (next test) and << (previous test) rather than using the tabs.
4 If you will need to change the Target value and the Std. deviation values of a control, on the Detail tab, select Use custom values .
The Target value and the Std. deviation fields are no longer grayed out and can be updated.
Creating a control material
5
Repeat the above steps 2 and 3 for other lots associated with the control material.
To create a Non-Roche control material: a cobas 8000 data manager QC Parameters > Control material
1 Right-click in Control overview , and then click Insert control material on the shortcut menu. The Insert control material dialog box opens.
2 Complete the fields according to the information from the control material manufacturer.
When filling in the information start from the Control material group box and then fill in the information sequentially through the dialog box.
Following fields are mandatory: o Control name o
Lot No.
o Expiry date o
Instrument o Test
3 To lock all relevant patient results after a QC failure, in the Lot group box, select the Lock validation check box. The validation lock applies to all tests within the selected lot. It overrules the validation lock in the Test group box.
4 To add additional tests to an instrument, click Save test and enter the new test details. Repeat this for as many tests as required.
5 Click OK . The Insert control material dialog box closes and the control material details are entered.
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6 To add additional lots and associated data to the control material, in Control overview click on the control material to which you want to add a lot.
7 Right-click in Lot overview , and then click Insert control lot on the shortcut menu. The Insert control material dialog box opens in which the control material data is entered and grayed out.
8 Enter the lot details as described in steps 2 to 5 and click OK . The Insert control material dialog box closes and the lot details are entered.
Tip
To edit control material, lot, or instrument related data, click the corresponding Detail tab and make the appropriate amendments and click Apply .
Deleting control materials
CAUTION
Caution a Control materials with associated results cannot be deleted.
When it is necessary to delete a control material: a cobas 8000 data manager QC Parameters > Control material
1 Use the filters at the top of the work area to locate the control material that you want to delete. The control material is listed in the Control overview table.
2 In the Control overview table, right-click the control material you want to delete, and then click Delete control material on the shortcut menu. A message box opens prompting you to confirm that you want to delete the control material.
3 Click Yes . The control material and associated lots and instruments are removed.
Viewing and printing control material and instrument assignment reports
In the Control material component you can view and/or print: o
Control material - instruments assignment reports: listing control materials and their associated instruments o Instrument - control materials assignment reports: listing instruments and their associated control materials.
To view and print control material assignment reports and instrument assignment reports in the Control material component: a cobas 8000 data manager QC Parameters > Control material
1
Right-click in the Control overview table, and then click Preview controlinstrument assignment or Preview instrument-control assignment on the shortcut menu.
In each case, a print preview window opens in which you can view the corresponding report.
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2 To print the report, click the printer icon on the menu bar of the report preview window.
Tip
To print a report directly, click Preview control-instrument assignment or Preview instrument-control assignment on the shortcut menu in step 1.
Setting the QC configuration
The QC configuration component comprises the QC modules tab and the QC options tab which enable you to: o Select a QC module ( QC modules tab).
o Make a comment compulsory if deviation and /or target values of a control are changed ( QC options tab).
o Send calibration recommendations to the instrument automatically ( QC options tab).
Currently the data manager only uses the Westgard QC module, and this is the only
(default) option on the QC modules tab.
To configure the QC options: a cobas 8000 data manager QC Parameters > QC configuration
1 Click the QC options tab.
2 Select / deselect the corresponding check box to make the following conditions apply / not apply: o A comment is compulsory when changing the deviation and target .
o Send calibration recommendation to instrument automatically .
3 Click Apply .
Working with Westgard rules
Westgard rules are validation rules used to evaluate control values. For a test you can define and evaluate several Westgard rules in parallel.
In the Westgard rules component, you specify the Westgard Rules that you want to use for quality control.
Westgard rules are based on various principles: o The deviation of the control value from the set value is evaluated.
o
The interval between two control values is evaluated.
o The trend of the results is evaluated (e.g. are control values increasing or decreasing? Are they all above or below the set value?).
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Tip
Please refer to the data manager online help for detailed definitions of the available
Westgard rules.
For the assessment of the quality of the determination of a test, several Westgard rules are combined into a ‘multi-rule’.
For each test for which you want to perform a QC run you must assign a Westgard rule set that defines the permitted deviation and the upper and lower boundaries.
The Westgard rules component contains the most commonly used Westgard rules.
You can also define, edit and delete rules.
A Westgard rule set can be assigned to more than one test.
Defining Westgard rules
To define a Westgard rule: a cobas 8000 data manager QC Parameters > Westgard rules
1 Right-click in the Westgard rules table, and then click Insert Westgard rule on the shortcut menu. The Insert Westgard rule dialog box opens.
2 From the Method drop-down list, select the appropriate method for the rule you are creating.
The method that you select determines the parameters that are displayed in the group box at the bottom of the dialog box.
3 Enter a Name and an appropriate Comment for the rule you are creating.
4 If the rule is to be applied to a single control of a test, select the Within control check box. If the rule is to be applied to two or more controls of a test, deselect the
Within control check box.
5 Select the appropriate parameters for the new rule.
6 Click OK . The Insert Westgard rule dialog box closes and the new rule is added to the Westgard rules table and automatically assigned an ID .
Editing Westgard rules
You can edit the comment and the parameters of a Westgard rule.
To edit a Westgard rule: a cobas 8000 data manager QC Parameters > Westgard rules
1 In the Westgard rules table (work area) right-click the rule you want to edit, and then click Edit Westgard rule on the shortcut menu. The Edit Westgard rule dialog box opens.
2 Edit values and click OK . The changes are saved.
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Deleting Westgard rules
Only unassigned Westgard rules may be deleted.
To delete a Westgard rule: a cobas 8000 data manager QC Parameters > Westgard rules
1
In the Westgard rules table, right-click the rule you want to delete, and then click
Delete Westgard rule on the shortcut menu. A message box opens prompting you to confirm that you want to delete the rule.
2
Click OK . The rule is removed from the Westgard rules table.
Assigning Westgard rules
In the Westgard rule assignment component, you specify which Westgard rules are to be applied for the evaluation of control values of a test.
After selecting a Westgard rule set you must assign it to one or more instrument tests.
The QC measurement result is evaluated based on the assignment of rule set(s) to instrument(s) and test(s).
The Westgard rule assignment can be done on three levels, each representing a subcomponent within the Westgard rule assignment component:
1.
Global assignment
2.
Test assignment
3.
Instrument test assignment
The Global assignment and the Test assignment components enable you to create global profiles, therefore you do not have to define a rule for every test and/or instrument.
The global assignment of Westgard rules assigns rules to all instruments attached to the data manager.
The test assignment of Westgard rules assigns rules to specific tests. Such assignments take precedence over global assignments.
The Instrument test assignment component enables you to assign rules to a specific tests / instrument combination. Such assignments take precedence over test assignments and global assignments.
For each rule assignment, you must enter a failure status ( Warning or Error ). This determines the consequences when the rule is not fulfilled.
The Warning failure status indicates the violation of a rule, but does not affect the release of results. It is used to indicate that the measuring quality has begun to decline and provides the opportunity to resolve this trend.
The Error failure status indicates the violation of a rule and locks the test for further test results. It is used when the quality of the measurement has greatly deteriorated.
All rule changes are registered in a History .
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Global Westgard rules assignment
The Global assignment sub-component enables you to assign Westgard rules to all instruments attached to the data manager, and to set a failure status and the date from which the rule assignment is valid.
Global Westgard rules can be overwritten by test assignments and by instrument test assignments.
To create Global Westgard rules: a cobas 8000 data manager QC Parameters >Westgard rule assignment>
Global assignment
1
In the Not assigned Westgard rules table, select the rule(s) that you wish to assign.
2
From the Failure status drop-down list, select the failure status that you want to apply to a QC result if the rule fails, and then click >> . The selected rule(s) are moved to the Assigned Westgard rules table.
Tip
Click << to move rules from the Assigned Westgard rules table to the Not assigned Westgard rules table if necessary.
Tip
You can change the failure status of rules in the Assigned Westgard rules table by right-clicking the appropriate rule(s), and then clicking Change failure status on the shortcut menu. The failure status is updated.
3
From the Valid from drop-down list, select the date from which you want the assigned rules to be applied.
4
Click Apply to all . The rules will be applied accordingly from the date that you selected.
Tip
Clicking History opens the History dialog box which contains all actions carried-out to Global Westgard rules indicating the user and date for each action.
Westgard rules - test assignment
The Test assignment sub-component enables you to assign Westgard rules to specific tests, and to set a failure status and the date from which the rule assignment is valid.
Test-assigned Westgard rules can be overwritten by assignments made for particular tests on particular instruments.
To create test assigned rules:
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QC Parameter a cobas 8000 data manager QC Parameters > Westgard rule assignment >
Test assignment
1 In the test table, click the test to which you want to assign rules.
2 In the Not assigned Westgard rules table, select the rule(s) that you wish to assign to the test.
3 On the Failure status drop-down list, select the failure status that you want to apply to the rules that you have selected.
Tip
You can change the failure status of rules in the Assigned Westgard rules table by right-clicking the rule(s) whose status you want to change, and then clicking Change failure status on the shortcut menu. The failure status is updated.
4 Click >> . The selected rule(s) are moved to the Assigned Westgard rules table.
Tip
Click << to move rules from the Assigned Westgard rules table to the Not assigned Westgard rules table if necessary.
5
From the Valid from drop-down list, select the date from which you want the
Tip assigned rules to be applied.
6
Click Apply to test . The rules will be applied to the test from the date that you selected.
Clicking History opens the History dialog box which contains all actions carried-out to Global Westgard rules indicating the user and date for each action.
Clicking View opens the Westgard rule for the instrument dialog box containing the
‘active rules’ for the assigned instrument for the selected test.
Westgard rules - instrument test assignment
The Instrument test assignment sub-component enables you to assign rules on a instrument-test level
Instrument assigned Westgard rules take precedence over both globally assigned rules and test assigned rules.
To create Instrument test Westgard assignment rules: a cobas 8000 data manager QC Parameters > Westgard rule assignment >
Instrument test assignment
1 In the instruments table double-click the instrument you wish to assign. The
Westgard rules - instrument test assignment work area is displayed.
Tip
Rules should only be assigned to the sub-modules of the instrument.
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2 In the tests table, click the test to which you wish to assign Westgard rules for the selected instrument.
Tip
Note that current rules assignment for tests is indicated in the Assigned active rules column of the tests table.
3 From the Valid from drop-down list, select the date from which you want the assigned rules to be applied.
4 In the Not assigned Westgard rules table, select the rule(s) that you wish to assign to the test and click >> . The selected rule(s) are moved to the Assigned
Westgard rules table.
Tip
Use << to move rules from the Assigned Westgard rules table to the Not assigned
Westgard rules table if necessary. Rules with a History flag cannot be moved.
5
From the Failure status drop-down list, select the failure status that you want to apply to the rules that you have selected.
Tip
You can change the failure status of rules in the Assigned Westgard rules table as follows: o Select the new status from the Failure status drop-down list. o Right-click the rule(s) whose status you want to change, and then click Change failure status on the shortcut menu. The failure status is updated.
Working with QC calibration and QC violation
The Calibration method rules component enables you to configure the data manager to recommend an instrument calibration when a test fails its associated
Westgard rules.
The Calibration recommendations component enables you to view calibration recommendations and to take the appropriate action.
Defining a calibration method rule
To define a calibration method rule: a cobas 8000 data manager QC Parameters > Calibration method rules
1
Right-click in the calibration method rules table, and then click Insert calibration method rule . The Insert calibration method rule dialog box opens.
2
In the Tests table, click the test for which you wish to make the calibration method rule.
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3 In the Westgard rules table, click the Westgard rule(s) that you want to apply to the calibration method rule.
Tip
Use [Ctrl] -click to select more than one Westgard rule.
4 In the Calibration methods table click the calibration method that you want to recommend when the selected test violates the selected Westgard rule(s).
Tip
Ensure that the calibration method that you select is a valid method for the test that
5
Click Apply if you want the Insert calibration method rule dialog box to remain open so that you can define a new rule.
Otherwise, click OK . The Insert calibration method rule dialog box closes and the rule(s) is added to the calibration method rules table.
Editing a calibration method rule
To edit a calibration method rule: a cobas 8000 data manager QC Parameters > Calibration method rules
1
In the calibration method rules table right-click the calibration method rule that you want to edit, and then click Edit calibration method rule on the shortcut menu. The Edit calibration method rule dialog box opens.
2
Make the appropriate changes in the Tests table, Westgard rules table, and the
Calibration methods table.
3
Click OK . The Edit calibration method rule dialog box closes and the calibration method rule is updated in the calibration method rules table.
Deleting a calibration method rule
To delete a calibration method rule: a cobas 8000 data manager QC Parameters > Calibration method rules
1
In the calibration method rules table right-click on the calibration method rule that you want to delete, and then click Delete calibration method rule on the shortcut menu. A message opens asking if you want to delete the selected rule(s).
Tip
Use [Ctrl] -click to select more than one calibration method rule for deletion.
2 Click Yes . The calibration method rules are removed from the calibration method rules table.
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Managing calibration recommendations
Calibration recommendations are triggered when a test fails a Westgard rule. The
Westgard rule and the recommended calibration are configured in the Calibration method rules component.
The Calibration recommendations component enables you to view the recommendations and decide whether to reject a calibration or to request the calibration be sent to the instrument. It also enables you to view the corresponding
QC error details.
The number of calibration recommendations are indicated in the Information window by the Pending calibrations message. Double-clicking the message opens a dialog box containing the Calibration recommendations component in which you can perform the same tasks as in the Calibration recommendations component.
Tip
Calibration recommendations can be sent to the instrument automatically by selecting the
Send calibration recommendation to instrument automatically option on the QC options tab of the QC configuration component ( cobas 8000 data manager QC
Parameters workplace).
To request or reject a calibration: a cobas 8000 data manager QC Parameters > Calibration recommendations
1 Use the Selection criteria to choose the appropriate values that will return the calibration recommendations you want to view, and click Apply . The corresponding calibration recommendations are listed in the calibration recommendations table.
Tip
If the selection criteria are not visible, click the + to the left of Selection criteria to make them visible.
2 In the calibration recommendations table right-click on a calibration recommendation, and then on the shortcut menu click: o Reject calibration to reject the recommendation.
o Request calibration to send the recommendation to the instrument.
Tip
To view the QC error details behind a calibration recommendation, right-click the recommendation, and then click Show QC error details on the shortcut menu.
QC Routine
You use the cobas 8000 data manager QC Routine workplace to: o
Retrieve QC results.
o Evaluate QC results.
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o
Add comments to QC results.
o Monitor standby bottles.
o
Print QC statistics and Levy-Jennings charts.
The cobas 8000 data manager QC Routine workplace has two components: o
QC Routine .
o QC Standby bottles .
The QC Routine component
The QC Routine component comprises the following elements: o Filter options .
o
Reference values table.
o Statistics table.
o
Control values table.
o Levy-Jennings chart.
The Filter options enable you to determine the QC results that you want to view.
This includes being able to view QC results only, Standby bottle QC results only, or both result types.
The result of filtering are displayed in the Control values table. When you click a result in the table, information corresponding to the result is displayed in the
Reference values table.
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Figure C-12
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QC Routine component
Tip
By using the Table visible check box and the Graph visible check box you can show either the table only, or the graph only as necessary. This makes better use of the available space, and enables you to view the table or the graph in more detail.
You can gain additional space by hiding the Navigation bar and Information window.
e
For more information see The cobas
8000 data manager interface (p. C-10)
The Reference values table and the Statistics table contain the corresponding values for the result that is highlighted in the Control values table.
The Levy-Jennings chart provides a graphical representation of result values for the control selected in the Control values table. It provides the following functionality: o
Representation of QC results and Standby bottle results (indicated by circular and square points respectively). When you place the mouse pointer over a result node of a graph, a tool tip containing information about the result is displayed.
o Indication of when a calibration has taken place, there has been a reagent change, or both.
o
Color coding of the standard deviation ranges (<2s, 2s to 3s, and >3s).
o Results displayed as absolute values or as the corresponding standard deviation values.
o
Super-imposition of charts by making multiple selections in the Control values table.
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O
left to right over the area you want to zoom into.
O right to left over the area you want to zoom out of.
Masking
QC locking based on instrument flags is possible.
When masking is triggered by QC errors, only patient masking only is requested.
This is because you may still want to perform QC / calibration on the masked test without having to manually un-mask the test).
Retrieving QC results
In the QC Routine component, you have filters to retrieve QC results for evaluation and other further use. You can select a combination of filter criteria, such as instruments, tests and control material in order to retrieve the required results.
To retrieve QC results: a cobas 8000 data manager QC Routine > QC Routine
1
If the selection criteria are not visible, click + to display the Filter options .
2
In the Filter options group box: o Select a time frame using the From and To , or enter the number of Days counting back from the current date.
o Use the remaining drop-down lists make your selection as precise as necessary.
3 Select the filter option Show all results or Show current results only .
Show all results displays all QC results including previous ones. Show current results only displays the latest results. The system stores all QC results.
Evaluating QC results
CAUTION
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After you have filtered the requested results, you must evaluate them according to the information provided by the test manufacturer.
Evaluating results consists of agreeing with the results and approving the instrument to perform this particular test.
Caution a You should not release patient results without first evaluating the QC results.
To evaluate QC results: a cobas 8000 data manager QC Routine > QC Routine
1 On the Control values tab, right-click the result you want to evaluate from the
QC results list, and then click one of the following commands on the shortcut menu: o Evaluate result o Evaluate result with comment to enter one or more comments to the selected result.
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Tip
After evaluating a result, the check box in the Evaluated column is automatically checked. Once a result is evaluated, you cannot re-evaluate it. If the result has an enclosed comment, the corresponding check box in the Comments column is also selected.
2 Select the Graph visible check box to view a graphical representation of the QC results.
All results from the table can be displayed graphically.
3 Move the cursor over any result to display available information (comments, value, lot etc.).
Releasing results with QC errors
You are able to release QC results which are not within the defined range. When you release a result with a QC error, all the results assigned to the test are released as well.
The following rules for releasing controls are applied as follows:
1. You can always release a locked control on the last active QC result. This will allow the release of new patient results again.
2. If a control error occurred and patient results were received which were validated against the failed QC result, the patient results may not be released until you have explicitly accepted (‘Released’) the QC result.
To release results with a QC error: a cobas 8000 data manager QC Routine > QC Routine
1 On the Control values tab, right-click a result which is out of range, but which you still want to release, and then click Release result .
You are requested to enter a comment for the command. The system releases the
QC result and all the results assigned to the test.
Adding comments to QC results
You can add and edit multiple comments to individual QC results. Additionally, you can print comments for individual results.
a cobas 8000 data manager QC Routine > QC Routine
1 Right-click an entry, and then click Insert comment on the shortcut menu. The
Insert comment dialog box opens.
2 Select or enter one or more comments.
Tip
Click New comment to enter additional comments to the entry.
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Monitoring standby bottles
You use the QC Standby bottles component to monitor the QC status ( OK , Error , or
No evaluation ) of standby bottles based upon the tests performed on them in order to undertake the appropriate action.
The result status evaluation is based on the range which is entered in Control
Material and not on defined Westgard rules.
The QC Standby bottles component comprises a table listing the results and a number of criteria by which you can filter the entries.
You are also able to: o Resend a result.
o
Flag an error as acknowledged.
as necessary.
To monitor standby bottles: a cobas 8000 data manager QC Routine > QC Standby bottles
1 Use the filters above the table to select the results that you want to view.
Tip
Use Only not acknowledged results , and either Show all results or Show current results only to further filter results.
The results corresponding to the filter selection are displayed in the table.
2 To resend a result, right-click on the result and then on the shortcut menu select
Resend result .
To flag an error as acknowledged, right-click on the result and then on the shortcut menu select Acknowledge error .
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21 Routine configuration
Table of contents
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The following chapter provides descriptions for the data manager configuration procedures which can be performed, if required, by the user after the initial installation and configuration process. Although it is possible for users to make changes to these configurations, we recommend this only be done by an experienced and qualified staff member.
In this chapter Chapter
21
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Configuring sample types
Configuring sample types
CAUTION
The Sample type component enables you to edit the sample types, e.g. blood serum, that are tested in the laboratory.
The cobas 8000 system is capable of processing the following sample types: o Serum / plasma.
o
Urine.
o Supernatant.
o
CSF.
o Whole blood.
o
Oral fluids.
Caution a These sample types are installed as defaults in the data manager and it is not possible to add further sample types.
The description of the sample type can be edited, but we recommend you do this only once in the early stages of the system configuration.
Editing a sample type
To edit a sample type: a cobas 8000 data manager Routine Configuration > Sample type
1 In the sample types table, right-click the sample type that you want to edit, and then click Edit sample type on the shortcut menu. The Edit sample type dialog box opens.
2 Edit the sample type according to your laboratory’s requirements.
3 Click OK to save the changes and close the dialog box.
Tip
Edit sample types as early as possible as you need them to define a test later on in the system configuration process.
e For more information on adding tests see
Creating a custom test (p. C-79).
Setting up test groups
The Test groups component enables you to assign tests to test groups. These test groups can then be used in the Routine workplace ( Day list and Technical validation components) for filtering.
You can add, edit and delete test group descriptions, however we recommend you do this only as a part of the initial set up.
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Setting up test groups
Adding a test group
To add a test group: a cobas 8000 data manager Routine Configuration > Test groups
1
Right-click anywhere in the test groups table, and then click Insert test group on the shortcut menu. The Edit test group dialog box opens.
2
Configure the test group according to your laboratory’s requirements. The
Description field contains the description that you assign to the test group.
3
Fill in the Position number according to the order in which you want the tests to be listed.
Tip
To ensure that you can add new tests between existing tests in the list at a later time, number your initial tests with 10 positions apart, e.g. 10, 20, 30 instead of 1, 2, 3.
Editing a test group
Tip
To view the details of a test assigned to the group, right-click the test, and then click
Open test on the shortcut menu. The Test / reference values dialog box opens containing the test details.
4
Click OK to save the changes and close the dialog box.
To edit a test group: a cobas 8000 data manager Routine Configuration > Test groups
1
In the test groups table, right-click the test group that you want to edit, and then click Edit test group on the shortcut menu. The Edit test group dialog box opens.
2
Edit the test group according to your laboratory’s requirements. The Description field contains the description that you assign to the test group.
3
Fill in the Position number according to the order in which you want the tests to be listed.
Tip
To ensure that you can add new tests between existing tests in the list at a later time, number your initial tests with 10 positions apart, e.g. 10, 20, 30 instead of 1, 2, 3.
Tip
To view the details of a test assigned to the group, right-click the test, and then click
Open test on the shortcut menu. The Test / reference values dialog box opens containing the test details.
4 Click OK to save the changes and close the dialog box.
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Configuring profiles
Deleting a test group
To delete a test group: a cobas 8000 data manager Routine Configuration > Test groups
1
In the test groups table, right-click the test group that you want to delete, and then click Delete test group on the shortcut menu. A confirmation message box opens.
2
Click OK to delete the test group.
Configuring profiles
The Profiles component enables you to manage test group profiles.
A profile puts tests into a single group, so that multiple tests can be selected for a sample with one selection. This simplifies the sample registration process. Profiles can be nested, i.e. profiles may contain sub profiles.
Test profiles are commonly performed together for clinical and billing reasons. In that case tests are generally grouped according to your country’s regulations, e.g.
Chem 6 in the USA.
Adding and defining a profile
When adding and defining a profile you can add tests which are performed within this profile.
To add a profile: a cobas 8000 data manager Routine Configuration > Profiles
1
Right-click in the profiles table, and then click Insert profile on the shortcut menu. The Profiles dialog box opens.
2
Enter a code and name for the profile, e.g. C7 and Chem 7.
3
Enter the appropriate Host code .
4
Select To request to include the profile as an option to be applied to a sample request in the LIS Backup component.
5
Click Apply to save the profile code definition.
6
To assign a test to the profile, right-click in the tests table (below the profile definition), and then click Assign new test on the shortcut menu. The Assign tests dialog box opens.
7
From the Test drop-down list, select the test you want to assign to the profile.
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8 Type in a Position number to determine the position in which the test will be listed in the tests table in the Profiles dialog box.
Tip
To ensure that you can add new tests between existing tests in the list at a later time, number your initial tests with 10 positions apart, e.g. 10, 20, 30 instead of 1, 2, 3...
9 Click Apply to save the test assignment.
10
Repeat steps 7 and 8 for as many tests as you want to assign to the profile.
11 Click OK to close the Assign tests dialog box. The assigned tests appear as entries in the tests table in the Profiles dialog box.
12 Click Cancel to close the Profiles dialog box. The new profile appears as an entry in the profiles table.
Editing a profile
You can edit elements of the profile definition, edit or delete assigned tests, and assign tests to the profile.
To edit a profile: a cobas 8000 data manager Routine Configuration > Profiles
1 In the profiles table, right-click the profile that you want to edit, and then click
Edit profile on the shortcut menu. The Profiles dialog box opens.
2 Edit the profile definition as necessary. You cannot edit the Profile code or the
Sample type .
3 You can do one of the following: o To edit a test assignment, right-click the test and then on the shortcut menu click Edit assignment . The Assign tests dialog box opens in which you can edit the Position value of the assigned test.
o To assign a new test, right-click in the tests table and then on the shortcut menu click Assign new test
on the shortcut menu. Follow steps 7 to 11 in
Adding and defining a profile (p. C-67) above.
o
To delete an assigned test, right-click the test and then on the shortcut menu click Delete assignment . The test is removed from the tests table.
4
Click Cancel to close the Profiles dialog box.
Deleting a profile
To delete a test profile:
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1 In the profiles table, right-click the test that you want to delete, and then click
Delete profile on the shortcut menu. A confirmation message box opens.
2 Click Yes . The profile is removed from the profiles table.
Masking profiles
The Masking profiles component enables you to define and maintain masking profiles.
Masking profiles provide a convenient means of simultaneously masking a number of tests on an instrument, and are used in the Test mask overview component of the cobas 8000 data manager Routine workplace.
When you create a masking profile you specify which tests on an instrument are to be included. Masking profiles are then activated and de-activated as necessary in the
Test mask overview component in the cobas 8000 data manager Routine
Tip workplace.
For example, routine tests which need only be performed during a night shift can be masked during the day to leave instrument free for other tests.
e
For more information see Masking and unmasking tests (p. C-38).
It is possible to mask and unmask tests individually using the Instrument sub-component of the Instrument component. On the Tests tab of the instrument sub-component right click the test that you want to mask / unmask and on the shortcut menu click the Activate automatic test masking when QC error option or the Deactivate automatic test masking when QC error option.
Be sure to use the instrument sub-component only to mask / unmask tests in this way. The instrument modules and sub-modules are also displayed as sub-components of the
Instrument component. However, masking / unmasking tests on their Tests tabs will not have any affect (i.e. tests will not be masked / unmasked).
Defining an instrument masking profiles
To define an instrument masking profile: a cobas 8000 data manager Routine Configuration > Masking profiles
1
Right-click in the masking profiles table, and then click Insert profile on the shortcut menu. The Masking profiles dialog box opens.
2
Enter a Profile ID and Profile name . Click Apply to save the profile ID and profile name, and to populate the Tests not assigned table.
3
In the Tests not assigned table select the tests you want to assign to the profile, and click << . The tests move to the Assigned tests table.
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4 Click OK to save the masking profile and close the Masking profiles dialog box.
The profile appears as an entry in the masking profiles table.
Editing an instrument masking profile
You can unassign tests from an instrument masking profile, or assign more tests to it.
To edit an instrument masking profile: a cobas 8000 data manager Routine Configuration > Masking profiles
1 In the masking profiles table, right-click the profile that you want to edit, and then click Edit profile on the shortcut menu. The Masking profiles dialog box opens.
2 Edit the Profile name if necessary. Click Apply .
3 You can unassign and assign tests to the masking profile: o To unassign tests to the masking profile, in the Assigned tests table select the tests you want to unassign and click << . The tests move to the Tests not assigned table.
o
To assign tests to the masking profile, in the Tests not assigned table select the tests you want to assign, and click >> . The tests move t o the Assigned tests table.
4
Click Cancel to close the Masking profiles dialog.
Deleting an instrument masking profile
To delete an instrument masking profile: a cobas 8000 data manager Routine Configuration > Masking profiles
1
In the masking profiles table, right-click the profile that you want to delete, and then click Delete profile on the shortcut menu. A delete confirmation message box opens.
2
Click Yes to delete the masking profile. The masking profile is removed from the masking profiles table.
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Configuring SOPs
Configuring SOPs
The SOP configuration component enables you to integrate Standard Operating
Procedures (SOPs), or other information that will assist the user, into the data manager.
An SOP / information is linked to a relevant interface element (e.g. window / dialog box field). The SOP / information is displayed in a popup (dialog box) which opens by pressing [ F2 ] when the cursor is in that interface element.
For example, there may be important information of which the user should be aware when entering a sample manually. The information can be linked to the first field of the LIS Backup component, and by pressing [ F2 ] when the cursor is in the field, the popup containing the information opens and can be read by the user.
Tip
In order to configure SOP popups, you must have been granted the administration right to do so. This is done using the User component in the cobas 8000 data manager
Administration workplace.
You configure SOP popups in two stages:
1. You define the popup that will open and display the SOP / information in terms of its title, size and location on the screen, and then assign the document to be contained in popup.
The popup can contain HTML files and PDF files.
2. You assign the popup to the appropriate interface element.
Defining an SOP popup
You must first define the popup and the SOP / information it will contain.
a cobas 8000 data manager Routine Configuration > SOP configuration
1 Right-click in the SOP popups table (work area), and then click New popup on the shortcut menu. The Create popup dialog box opens.
2 Enter the appropriate detail to define the SOP popup and its content:
Title is the name that appears on the popup title bar.
The Top and Left values (pixels) locate the position of the popup’s top left corner, from the top edge and left edge of the data manager window.
Parameter contains the location of (link to) the information to be contained in the popup. You must use the following syntax:
For HTTP:
[url=http://intranet.yourcomany.com/sop.html]
For PDF:
[url=file://C:\Roche\SOP\sop.pdf]
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Tip
The data manager contains a pre-defined folder that is used to store PDFs that are used in popups:
C:\Roche\SOP
3 Click OK . The Create popup dialog box closes and the SOP popup is entered in the SOP popups table.
The SOP popup is also added to the navigation tree as a sub-component of the
SOP configuration component.
Assigning an SOP popup
After you have created the popup and its content, you can assign it to one or more interface elements.
There are two types of assignment: o Master assigns an SOP popup to an element in the window. You cannot define variables.
o Detail enables you to select field-specific variables and assign a value to them.
This enables you to specify the conditions under which the SOP popup is opened.
To assign an SOP popup: a To assign an SOP popup
1 Locate the appropriate component / sub-component and select the element to which you want to assign the popup.
2 Press [F3] . The Assign SOP dialog box opens.
3 Enter the appropriate detail and from the Popup drop-down list, select the SOP popup you wish to assign
Tip
You can preview the selected SOP popup by clicking the ‘...’ button beside the Popup drop-down list.
4
Click Save . The Assign SOP dialog box closes and the SOP popup is assigned to the interface element.
Tip
You can now open the popup and view its content by pressing [ F2 ] when the cursor is in the field.
Monitoring SOP popups
After you have assigned an SOP popup to interface elements you can view to which elements it is assigned using the Popup details and assignment dialog box.
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Managing processing intervals a cobas 8000 data manager Routine Configuration > SOP configuration
1 In the SOP popups table, right-click the SOP popup you wish to view, and then click Edit popup on the shortcut menu. The Popup details and assignment dialog box opens.
2 The table at the bottom of the dialog box lists the interface elements to which the
SOP is assigned.
3 Close the Popup details and assignment dialog box.
Managing processing intervals
The Processing intervals component enables you to manage the processing interval color-coding which provides a visual indication of the time elapsed since an order was created.
Processing intervals are defined by order priority (e.g Default, Routine, STAT) and represent a period of time that has elapsed since the creation of an order for a given priority.
For example, for routine priority, the period from an order’s creation (time =0 minutes) to 30 minutes could be represented by green. The time period from 31 minutes to 45 minutes could be represented by yellow and so on.
Processing intervals are used in the Sample overview , Day list and Technical validation components.
Creating a processing interval
Processing intervals are created and edited using the Processing interval dialog box.
To create a processing interval: a cobas 8000 data manager Routine Configuration > Processing intervals
1 Right-click in the processing interval table, and then click Insert processing interval on the and on the shortcut menu.
The Processing interval dialog box opens.
Tip
To edit an existing processing interval, right click the time interval and then click Edit processing interval on the short cut menu. You can then edit the existing values in the Processing interval dialog box.
2
Enter the details and select an appropriate color for the new processing interval.
Tip
Processing intervals for a priority cannot overlap. For example, if a time interval of 0 to
30 minutes has been created. You cannot create a new time interval for the same priority with a starting time < 30 minutes.
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3 Click OK .
The Processing interval dialog box closes and the processing interval is added to the processing interval table.
Deleting a processing interval
Processing intervals can be deleted in the processing interval table.
To delete a processing interval: a cobas 8000 data manager Routine Configuration > Processing intervals
1 In the processing intervals table right-click the processing interval that you want to delete, and then click Delete processing interval on the shortcut menu.
A message opens asking you to confirm the delete.
2 Click Yes .
The processing interval is removed from the table.
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Table of contents cobas ® 8000 modular analyzer series
Test configuration
This chapter primarily provides information explaining how you edit and define tests their reference ranges and associated information, and how you can integrate in formulas to accomplish more complex testing.
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22
Defining primary and secondary measurement units for a test......................... C-88
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Table of contents cobas ® 8000 modular analyzer series
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Working with tests and reference ranges
Working with tests and reference ranges
CAUTION
The Tests / reference ranges component is used for the administration and maintenance of all tests.
There are two main types of tests: o Pre-defined (Roche) tests (come from the instrument after a download from
TSN).
o
Custom (non-Roche) tests (created on the data manager).
Pre-defined tests will normally constitute the vast majority of available tests.
Consequently, you may need to edit test definitions, and will need to define the appropriate reference ranges.
You can create (custom) tests using the Tests / reference ranges component. You can also create tests in conjunction with the Formulas component.
e
For more information see Formulas (p. C-89).
The principle activities that you undertake in the Tests / reference ranges component are: o
Editing / defining a test definition.
o Defining / editing the reference ranges for a test.
o
Defining / editing result conversion rules for a test.
o Maintaining result texts for a test.
o
Editing detection limits for a test.
o Activating / deactivating tests.
Each of these activities are explained in this section.
Caution a Please note that users bear responsibility for the correctness of the outcomes to all rules and formulas that they define.
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Editing a test definition
cobas ® 8000 modular analyzer series
You can edit pre-defined tests and custom tests using the Test / reference ranges dialog box.
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Figure C-13 Test / reference ranges dialog box
To edit a test definition: a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the tests table, right-click the test you want to edit, and then click Edit test on the shortcut menu. The Test / reference ranges dialog box opens.
2 The fields that you can edit in the Test definition group box depend upon the type of test that you are editing (i.e. pre-defined or custom): o For pre-defined tests you are only able to edit Host code , Decimal places in
Report and Confidential result . You can also edit the Standby QC SD range which contains the default values (2 SD for Clinical Chemistry and ISE instruments, and 3 SD for Immunology instruments).
o For custom tests you can edit Host code , Test , Test group , and Decimal places in Report , Decimal places for result display and Confidential result .
Confidential result
By selecting the Confidential result check box for a test, only users with user right
Read confidential results assigned to them can: o enter a result for the test.
o view the result of the test.
o validate the test result.
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Working with tests and reference ranges
3 In the Workflow group box you can select / deselect the Automatic release check box to enable / disable automatic release of results for this test which are within the technical validation range.
If you select the Automatic release check box you have two additional options that you can select: o Release repetitions which enables results from repeated tests to be released automatically, if they are within the defined range.
o
Ignore technical validation range enables the technical release of a result independent of the value i.e. even when the value is outside the given range.
4
In the Secondary unit group box, from the Secondary units drop-down list select the secondary units as required. For example, some laboratories require that results are delivered using more than one unit of measurement.
e
For more information see Configuring test measurement units (p. C-87).
When secondary units are being used, edit / enter a value in Decimal places in
Report as necessary. This determines the number of decimal places shown for this test in test result reports.
Tip
Secondary units only apply to the Single result report (two units) (available in the cobas 8000 data manager Routine workplace). They cannot be seen in the data manager application other than in report previews, and are not sent to host.
5 If you are editing a custom test, you can edit an existing formula (indicated by the selected check box Has formula ), or add a formula. Clicking Formula opens the
Formula for dialog box in which you can do this.
e
For more information see Formulas (p. C-89).
Tip
You cannot edit the formula for an pre-defined test.
6
You can do one of the following: o Click Apply . Any changes that you have made are saved and the Test / reference ranges dialog box remains open. At this point you could define or edit the test reference ranges.
o Click OK . Any changes that you have made are saved and the Test / reference ranges dialog box closes. o If you are editing a custom test, you can click Insert New . Any changes that you have made are saved. The Test / reference ranges dialog box remains open with same test definition fields remaining populated. You can use them as the basis for the creation of the new test.
Creating a custom test
You can add additional tests using the Tests / reference ranges component. You can also create tests in conjunction with the Formulas component.
To create a custom test:
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Working with tests and reference ranges cobas ® 8000 modular analyzer series a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the tests table, right-click in the table, and then click Insert test on the shortcut menu. The Test / reference ranges dialog box opens.
2 In the Test definition group box complete the following fields:
Tip
The Test No.
field is automatically assigned by the system.
o In the Test field, enter the name or description of the test.
o In the Abbreviation field, enter the abbreviation for the name or description of the test.
o From the Test group drop-down list, select the group to which the test has been assigned.
Tip
Test groups are defined in the Test groups component in the cobas 8000 data manager Routine Configuration workplace. e
For more information see Setting up test groups (p. C-65)
o Change or enter the Host code as appropriate.
o From the Sample type drop-down list, select the name of the sample type on which you would perform this test, e.g. Cerebral spinal fluid.
o From the Module drop-down list, select the Laboratory Information System
(LIS) you are working in. These modules are configured during the initial installation and configuration stage.
o In the Symbolic name field, enter an additional name for the test which is an identifier in the host system.
o In the Method/manufacturer field, enter the name of the test method and manufacturer of the test reagent.
o From the Decimal places for result display drop-down list, select the number of decimal places to which the results of this test will displayed on the screen.
o Standby QC SD range contains the default standard deviation value used in
Standby bottle QC evaluation (2 SD for Clinical Chemistry and ISE instruments, and 3 SD for Immunology instruments).
You can modify this value if necessary. Decimal values are permitted (e.g.
‘2.3’).
o From the Decimal places in Report drop-down list, select the number of decimal places to which the results of this test should be shown in test reports. o Select the Confidential result check box if you only want users with the user right Read confidential results assigned to them to be able to:
O enter a result for the test.
O view the result of the test.
O validate the test result.
o In the Units field, enter the unit of measurement in which the results to this test are reported, e.g. mmol/L. This field accommodates a maximum of 15 characters.
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22 Test configuration
Working with tests and reference ranges
Caution a Please be aware that if you change the unit of a test you must also change all of the ranges that have been defined for this test.
a The unit of measurement is applied independently of the test date, so a modified unit of measurement would be applied to historical results as well as future results.
Consequently historical result data would be inaccurate.
We recommend that you create a new reference range for the test instead.
3 In the Workflow group box, select the Automatic release check box to enable automatic release of any results for this test which are within the technical validation range.
4 In the Secondary unit group box, from the Secondary units drop-down list, select the appropriate secondary units. For example some laboratories require that results are reported using more than one unit of measurement.
e
For more information see Configuring test measurement units (p. C-87).
In the Decimal places in Report field, enter the number of decimal places that will be applied to results of this test in reports, when the test’s secondary unit is used.
Tip
Secondary units only apply to the Single result report (two units) (available in the cobas 8000 data manager Routine workplace). They cannot be seen in the data manager application other than in report previews, and are not sent to host.
5
In the Formula group box, click Formula to create a formula for the test if appropriate. The Formula for <test name> dialog box opens in which you can create a formula.
e
For more information see Creating a formula (p. C-90).
6
You can do one of the following: o
Click Apply . The test is assigned a number and the Test / reference ranges dialog box remains open. You can continue and define the reference ranges for the test.
or, o Click Insert New . The new test is added to the tests table. The Test / reference ranges dialog box remains open with same test definition fields remaining populated. You can use them as the basis for the creation of the new test.
or, o
Click OK . The test is assigned a number and the Test / reference ranges dialog box closes.
Tip
If you click Insert New or OK you can define the reference ranges for the test you have created at a another time using Edit test .
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Working with tests and reference ranges cobas ® 8000 modular analyzer series
Defining reference ranges for a test
Pre-defined tests and custom tests require reference ranges defining. You can define the reference ranges by editing existing tests (e.g. pre-defined tests), or when you are defining a test (e.g. custom tests).
Reference ranges play a particularly important role in the automated throughput of tests. The ranges (e.g. technical validation) can be used to determine whether or not a test is automatically validated.
You can also define actions (a reflex, repeat, or adding a comment) which are determined by reference ranges.
A reference range for a test is specified for a patient group, which is defined in terms of age and gender. Therefore it is possible that there will be more than one reference range for a test.
The reference ranges for a test are displayed on the Reference ranges tab of the corresponding Test / reference ranges dialog box after being defined using the
Reference range for <test name> dialog box.
Figure C-14 Reference range for <test name> dialog box
Defining reference ranges for a test
You can define four ranges within a reference range: o User-defined range : the range according to your laboratory’s specifications.
o
Normal range : the range within which a result is normal for a healthy patient.
o Critical range : the range in which a result is not normal, but still not unhealthy.
o
Technical validation range : the range within which the system can technically validate the result. This range is used when automatic technical validation is performed.
A range is expressed using one of the following methods:
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Working with tests and reference ranges o A Lower limit and an Upper limit .
o
Relative to a value:
O Less than (<).
O
Less than or equal to (<=).
O Greater than or equal to (>=).
O
Greater than (>).
o As a comma separated list of alphanumeric value.
Tip
Ensure that you define the range within which a test result is valid i.e. no action is required.
For example, if you are defining a Critical range where a test must be repeated when the test result value is greater than 15, you would enter "<=15".
To define a reference range for a test: a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 If you are defining reference ranges for a test that is already defined, in the tests table, right-click the test you want to edit, and then click Edit test on the shortcut menu. The Test / reference ranges dialog box opens.
2 To add a new reference range for the test, right-click in the Reference ranges tab table, and then click Insert reference range on the shortcut menu. The Reference range for <test name> dialog box opens.
3 Complete the following fields: o In the Priority field, enter a number to indicate the priority with which this reference range is applied to the test. This value will be applied when more than one reference range is assigned to the test. Priority 1 is the highest.
o From the Age unit drop-down list, select whether the patient age group is measured in years or days.
This works in conjunction with From and To , to indicate the age range of patients to which this reference range applies.
If age is not relevant to the reference range, select the Any age check box. Age range values cannot be entered when this is selected.
o From the Sex drop-down list, select the gender of the patients to which the reference range applies.
4
For the ranges you wish to assign to the test ( User-defined range , Normal range ,
Critical range , and Technical validation range ) specify the criteria to be applied, using one of the available methods: o
Entering a Lower limit and Upper limit of the range.
o Selecting an inequality symbol ( < , <= , >= , > ) in conjunction with a value.
o
Entering the alphanumeric values (representing the results that fall within the defined range).
Tip
These values are defined at, and must correspond with, the cobas 8000 instrument.
5 You can do one of the following: o Click Apply . The reference ranges that you have entered are saved and the
Reference range for <test name> dialog box remains open. At this point you
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Working with tests and reference ranges cobas ® 8000 modular analyzer series could now add actions to be performed in the event of a violation of a
reference range (See Defining actions for a reference range (p. C-84)).
or, o
Click OK . The reference ranges that you have entered are saved and the
Reference range for <test name> dialog box closes. The reference ranges are added as an entry on the Reference ranges tab.
or, o below.
o
Click Insert New . The reference ranges that you have entered are saved and will be added as an entry on the Reference ranges tab. The Reference range for <test name> dialog box remains open and the reference range fields remain populated with the values of the previous reference range. You can use the values as the basis for a new set of reference ranges for the test.
Defining actions for a reference range
For each reference range that you create you can assign one or more actions to be performed when a test violates (falls outside) a range. The available actions are: o
Perform a reflex test.
o Perform a repeat with dilution.
o
Add pre-defined result / sample / test comments.
The actions are listed in the Reference range actions table of the Reference range for
<test> dialog box. They are listed in the order in which they are performed.
It is possible to stop actions being performed after a particular action has been executed. When defining an action you can select the Stop when executed check box.
Doing so will stop any further actions being performed after the action has been executed.
If a test result violates more than one range, all corresponding actions are performed.
For example, if you have a reference range of ‘>15’ and another range set to ‘<20’, a test result of ‘17’ would mean the corresponding actions of both ranges would be executed (unless the first action has Stop when executed selected).
You can define actions for reference ranges that have already been created, or you can define actions as you create reference range. Existing actions can be edited or removed.
To define actions for a reference range: a cobas 8000 data manager Test Configuration > Tests / reference ranges
> Reference ranges for <test>
1 Right-click in the Reference range actions table and on then click Insert Action on the shortcut menu.
The Insert Action dialog box opens.
2 From the Condition drop-down list, select the condition that will invoke the action.
3 From the Action drop-down list, select the action that is invoked for the
condition you selected in step 2.
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4 Select the Stop when executed check box if you want no further actions to take place for this reference range after this action has been performed.
5 Click OK .
The Insert Action dialog box closes and the action is added to the Reference range actions table.
Defining result conversion rules
The Result conversion rules tab contains the conversion rules for results sent from the instrument. The conversion rules convert results sent by the instrument and used in conjunction with the reference ranges.
You can define as many conversion rules as required. The use of the conversion rules is dependent on the priorities assigned to the rules.
a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the Test / reference ranges dialog box click the Result conversion rules tab.
The content of the tab is displayed.
2 Select the appropriate result type by clicking either Numeric results or
Alphanumeric results .
3 Set the range definition by selecting the appropriate sign from the if result is drop-down list, and typing in the corresponding value in the adjacent field.
For example, for a numeric results: >= and 1.5
4 Enter the Priority with which this conversion should be applied in relation to the other defined conversion rules.
5 Click Insert to save the conversion rule. The conversion rule appears in the table below.
6 To delete a conversion rule, right-click the rule in the table you want to delete, and then click Delete conversion on the shortcut menu.
Defining and editing result texts
Result texts are defined here for selection when manually entering alphanumeric test results in the data manager.
a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the Test / reference ranges dialog box click the Result texts tab.
The content of the tab is displayed.
2 To create a new result text: o Right-click the result texts table, and then click Insert value on the shortcut menu. The Text input dialog box opens.
o
In the Text field, enter an alphanumeric test result that will be used.
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Working with tests and reference ranges cobas ® 8000 modular analyzer series o In the Position field, enter the number to configure the order in which you want the result texts to appear in the Result entry dialog box.
o
Click Apply to save the data and add a additional result texts, or click OK to save the data and return to the Test / reference ranges dialog box.
To edit a result text: o
Right-click the result text in the table, and then click Edit value on the shortcut menu. The Text input dialog box opens.
o Edit the Text and Position fields as necessary.
o
Click OK to save the data and return to the Test / reference ranges dialog box.
3
To delete a result text, right-click the result text in the table, and then click Delete value on the shortcut menu.
Tip
The result text is deleted without prompting for confirmation.
Defining detection limits
You use the Detection limits tab to maintain detection limits for a test where appropriate (e.g. immunology-related). EP-17 flagging operates for: o Lower detection limit.
o The Limit of Blank (LoB), the Limit of Detection (LoD), and the Limit of
Quantitation (LoQ).
To define detection limits for a test: a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the Test / reference ranges dialog box click the Detection limits tab.
The content of the tab is displayed, on which the instrument types with which the test is associated are listed.
2 Right click the instrument type for which you want to define detection limits, and on the shortcut menu click Edit detection limits .
The Detection limits dialog box opens.
3 Enter the appropriate values in either; o the Lower detection limit or, o the Limit of Blank , the Limit of Detection , and the Limit of Quantitation .
4
Click OK .
The Detection limits dialog box closes and the detection limits are entered on the
Detection limits tab.
Tip
To edit detection limits, follow the same steps and amend the details accordingly.
To delete detection limits, follow the same steps and remove the details.
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Configuring test measurement units
Activating and deactivating a test
You are only able to deactivate and activate custom tests. When a test is deactivated it cannot be used.
When a test is deactivated, the text of its tests table entry is gray.
Tip
When you deactivate a test which is part of a formula, the formula is also deactivated.
Equally, you can not activate a formula containing a deactivated test.
e
For more information about formulas see Managing formulas (p. C-90).
To activate / deactivate a custom test: a cobas 8000 data manager Test Configuration > Tests / reference ranges
1 In the tests table, right-click the test you want to activate or deactivate, and then select Activate test or Deactivate test on the shortcut menu. The test is activated or deactivated accordingly.
Configuring test measurement units
The data manager uses primary and secondary measurement units to define test calculations and output.
Primary measurement units are used in the test definitions and are the main unit of measurement in all test calculations performed.
Where appropriate, you can output test values to reports using secondary measurement units. The secondary measurement unit is calculated by applying the appropriate conversion factor to the test’s primary measurement unit.
Primary and secondary measurement units are used in test definitions.
e
For more information on defining tests see Working with tests and reference ranges
You use the Component for test units component to configure secondary measurement units, and the tests to which they apply.
There are three main stages when you define secondary measurements:
1. Copy the (primary) units of measurement from the tests used by the data manager.
2. Create any secondary units of measurements to be used if none of those copied can be used.
3. For a primary unit of measurement, define its secondary unit of measurement by applying the appropriate conversion factor, and indicating the test to which both units of measurement will apply.
You can also create measurement units in the Tests / reference ranges component when you are defining a test. You can copy the measurement units from tests to the
Component for test units component.
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Configuring test measurement units
Copying and creating units of measurements
You should first copy all units of measurement from the tests used by the data manager. These units of measurement can be used as primary, and where appropriate, secondary units of measurement.
If you need to apply secondary units of measurement which were not in those copied from the tests, you must create them.
To copy primary unit of measurements from tests and create secondary units of measurement: a cobas 8000 data manager Test Configuration > Component for test units
1
Right-click in the units table (top), and then click Insert all units from test table on the shortcut menu. The units of measurement from all tests are listed in the units table.
2
If you need to create additional (secondary) units of measure, right-click in the units table and then click Insert units on the shortcut menu. The Test units dialog box opens.
3
In Units enter the letters representing the measurement unit and in Description enter the appropriate description.
to the units table.
4
Click OK . The Test units dialog box closes and the unit of measurement is added
Defining primary and secondary measurement units for a test
By defining a primary and secondary immurement unit for a test, the secondary measurement will then be available for selection in the test’s definition, and will be applied appropriately thereafter.
e
For more information see Editing a test definition (p. C-78).
To define primary and secondary measurement units for a test: a cobas 8000 data manager Test Configuration > Component for test units
1
In the units table (top), right-click the measurement unit to be used as the primary unit, and then click Edit units on the shortcut menu. The Test units dialog box opens.
2
Right-click in the conversion factor table, and then click Insert conversion factor on the shortcut menu. The Conversion factor dialog box opens in which
Primary units have been automatically entered.
3
From the Secondary units drop-down list, select the measurement unit you want to apply as secondary measurement unit.
4
From the Test drop-down list, select the test for which the primary and secondary measurement units are to apply.
Tip
If you leave the Test field empty, the unit is available for use for all tests.
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Formulas
5 In the Conversion factor field, enter the value which when applied will convert a primary measurement unit value to the corresponding secondary measurement unit.
6 Click OK . The Conversion factor dialog box closes and the corresponding values are added to the conversion factor table.
7 Click Cancel to close the Test units dialog box. The primary and secondary units, test, and conversion factor appear as an entry in the conversion factor table
(bottom).
Formulas
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Formulas enable you to calculate new test results that are based on measured test results (e.g. ratios).
Depending upon what you want to achieve by using a formula, you will base its output upon one or more validated test results. The formula output is validated by the corresponding reference values that have been defined in the Tests / reference ranges component.
e For more information on defining reference ranges see
Defining reference ranges for a test
You create, manage and monitor formulas in the Formulas component. You can also create formulas in the Tests / reference ranges component when you are creating or editing tests.
Tip
It is not possible to add formulas to Roche tests.
A formula contains a rule that calculates an output based upon the inputs to the formula. The formula inputs are one or more tests and numbers (numerical constants). You combine the inputs with the mathematical functions provided by the data manager to build a formula.
Tip
Formula output: o When the output of a formula is ordered, the input tests are automatically ordered.
o In the case of errors in the calculation, the calculated test result will be flagged and the calculated test result will be replaced by error text.
Error text with a flag will be sent to the host. The component test results will not be affected and will be maintained as received from instrument.
A formula is identified by a number which is automatically allocated when you create it, and is appended by a revision (version) number which enables you to track changes that you make to it. For example, 5.3 represents formula five is in its third revision.
A formula and its revision(s) each have a status reflecting the position of the formula in its life cycle. The possible statuses are:
Formula:
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Formulas cobas ® 8000 modular analyzer series
CAUTION
Managing formulas
o Draft (formula is being created).
o
Active (formula is being used in calculations).
o Inactive (formula is currently not being used).
o
Removed (Formula can no longer be used).
Revision: o
Draft (revision is being created/revised).
o Current (revision is being used in calculations).
o
Outdated (revision is no longer current).
Finally, a formula is either Active or Inactive . When a formula is active, it is used in test calculations. When a formula is inactive, it will not be used in test calculations.
This section describes formula management (creation, editing, deleting) and formula monitoring (tracking the status and life of formulas).
Caution a Please note that users bear responsibility for the correctness of the outcomes to all rules and formulas that they define.
Managing formulas includes the following activities: o o
Creating formulas.
Modifying formulas.
o
Activating and de-activating formulas.
o Removing formulas.
Creating a formula
You create a formula using the Formula definition dialog box which can be accessed from one of the following: o The Test / reference ranges dialog box when you are creating or editing a test
( Tests / reference ranges component).
e
For more information see Working with tests and reference ranges (p. C-77).
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22 Test configuration
Formulas
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Figure C-15
In each case the main stages in creating a formula using the Formula definition dialog box are:
Formula dialog box
1. Defining the formula (name, definition and output result).
2. Selecting the input tests and numbers to be used in the formula.
3. Building the rules to be used in the formula.
Tip
If the formula you want to create is similar to an existing formula, it might be quicker to make a copy of the existing formula and amend it accordingly.
In the formulas table ( List sub-component) right-click the formula on which you want to base the new formula, and then click Copy formula on the shortcut menu. The Formula definition dialog box opens containing the new formula with the settings and rule from the copied formula.
The new formula has a number, but requires a Name and Description , an output Result selection, and any appropriate amendments.
To create a formula: a cobas 8000 data manager Test Configuration > Tests / reference ranges cobas 8000 data manager Test Configuration > Formulas > List
1
To create a formula when working in the Test / reference ranges dialog box of a test ( Tests / reference ranges component), click Formula .
To create a formula in the List sub-component, right-click in the formulas table and, and then click New formula on the shortcut menu.
In each case the Formula definition dialog box opens.
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Tip
When the Formula definition dialog box opens, the Formula information group box contains the formula number and status (Draft), and the revision status (Draft).
The formula number is also displayed on the Revisions drop-down list at the bottom of the dialog box.
In each case a revision number has not yet been assigned.
2 In Name enter an appropriate name for the formula.
3 In Description enter a description of what the formula performs.
4 From the Result drop-down list, select the test which you want to use as the result of the formula. The test appears as the formula result (green button) in the
Formula result tree.
Tip
The button is only green if the test is active in the list of formula objects.
Tip
If you have accessed the Formula definition dialog box from a test in the Test / reference ranges dialog box, the output result in the Result drop-down list defaults to that test. You need not make a selection.
Tip
A test can be used as a formula output by one formula only. When you select a test from the Result drop-down list to be the formula output and it is being used as a formula output by another formula, a message is displayed informing you of this.
5 Select the formula inputs as follows:
Tests : o From the Input tests drop-down list ( Element declaration group box), select the test whose result you want to be used in the formula rule, and press
[Enter] . The test moves to the Formula input tree.
o Repeat the previous step for as many tests that you will use.
Numbers : o In Num. const.
( Element declaration group box) type in the value of the number that you want to be used in the formula rule, and press [Enter] . The number moves to the Constant tree.
o Repeat the previous step for as many numbers that you will use.
Tip
If necessary, you can still select additional tests and numbers as described above, after you have started to build the formula rule.
6 Drag the Formula result and drop it on the text Drop item here in the formulacreation pane. A result = icon opens in the rule-creation pane.
Tip
Ensure that you drop the Formula result on the text. Trying to drop it anywhere else in the formula-creation pane will display a ‘No entry’ icon on the mouse pointer, indicating that it cannot be dropped.
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Modifying a formula
22 Test configuration
Formulas
7 To build the formula rule you must drag the o Input tests from the Formula input tree.
o
Numbers from the Constant tree.
o Appropriate numerical functions from the Math tree.
and drop and arrange them inside the parenthesis of the result = icon.
Tip
To remove a Formula input or a Constant from the rule in the result = icon, rightclick the component, and then click Remove on the shortcut menu.
To remove a Math component you must select it by clicking it, and then press
[Delete] .
8 When you have built the formula rule, click Set to current . The formula status changes to Active and the revision status changes to Current ( Formula information group box).
The formula is given a revision number of 1 in the Formula information group box, and 1 is appended to the formula number on the Revisions drop-down list.
9 Click Close to close the Formula definition dialog box.
If you were creating the formula from the Test / reference ranges dialog box, you are returned to it.
If you were creating a formula in the List sub-component, the formula is added to the formulas table.
You modify a formula using the corresponding Formula definition dialog box.
When you modify a formula, a draft copy is created upon which you can work. When you have made the appropriate amendments you have the option to set the draft to current or to discard the draft.
When you set the (modified) draft formula to current, the draft replaces the existing current formula and the formula revision increments by one (e.g. the formula number 5 would go from 5.2 to 5.3).
If you discarded the modified draft it is removed and the existing current formula remains current.
Tip
If you want to continue modifying a formula at a later time, close the Formula definition dialog box. The draft copy of the formula is saved in the formulas table.
When you open the draft again to work on it, the Formula definition dialog box opens in edit mode.
Tip
When you are modifying a formula in the Formula definition dialog box you have access to the logs of the formula and to its history by clicking Log and History respectively.
To modify a formula:
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Formulas cobas ® 8000 modular analyzer series a cobas 8000 data manager Test Configuration > Formulas > List
1 In the formulas table, either: o Double-click the formula that you want to modify.
Or, o Right-click the formula that you want to modify, and then click Open formula on the shortcut menu.
In each case the Formula definition dialog box opens, containing the formula you want to modify.
2 Make the necessary amendments to the formula.
Tip
To remove a Formula input or a Constant from the rule in the result = icon, rightclick the component, and then click Remove on the shortcut menu.
To remove a Math component you must select it by clicking it, and then press
[Delete] .
3 Either: o Click Set to current . The Formula definition dialog box closes and the modified formula becomes the current formula in the formulas table. The revision number has incremented by one.
o Click Discard . The Formula definition dialog box closes and the existing current formula remains current.
o Click Close . The modified copy of the formula is saved in the formulas table as a (draft) revision, and can be modified at a later time.
Tip
In step 3 c) above, you can remove a draft revision by right-clicking it, and then clicking Discard revision on the shortcut menu. A message box asks you to confirm that you want to take this action.
Click OK . The revision is removed.
De-activating and activating a formula
When you set a formula to Current , it is Active by default, and will be used in test calculations. If you do not want a formula to be included in test calculations you must de-activate it.
In the formulas table ( List sub-component), the color-coding of a formula’s status indicates whether it is active (green) or inactive (red).
To de-activate or activate a formula:
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Formulas a cobas 8000 data manager Test Configuration > Formulas > List
1 In the formulas table, right-click the formula that you want to de-activate (green formula status) or activate (red formula status), and then click Deactivate formula or Activate formula on the shortcut menu.
The formula is de-activated or activated respectively and the formula status color changes accordingly.
Tip
The inclusion of the active / inactive formulas in the formulas table will depend upon whether the Show active formulas and Show inactive formulas filters ( Selection parameters ) are selected or not.
Removing a formula
When you have no further use for a formula you can remove it. When you remove a formula, all revisions of the formula remain in the formulas table ( List subcomponent) but cannot used again (i.e. you can open any revision to look at, but cannot edit).
Tip
You can use a removed formula revisions as the basis of a new formula by copying one.
e
For more information see Creating a formula (p. C-90)
A removed formula revision is indicated by the formula status of removed and the revision status of outdated, and each being color-coded black.
To remove a formula: a cobas 8000 data manager Test Configuration > Formulas > List
1
In the formulas table, right-click the formula that you remove, and then click
Remove formula on the shortcut menu. A message box opens asking you if you want to remove the formula.
2
Click OK . The Formula status and the Revision status change to Removed and
Outdated respectively, and each is color-coded black.
Tip
The inclusion of the removed formula revisions in the formulas table will depend upon whether the Show removed formulas and Show outdated revisions filters
( Selection parameters ) are selected or not.
Monitoring formulas
The List , Log and History sub-components enable you to monitor the use of formulas in terms of their status changes, runs and life cycle.
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Using the formulas list cobas ® 8000 modular analyzer series
As well as enabling you to manage formulas the List sub-component provides you with a means of monitoring formulas.
The List sub-component comprises selection parameters, and the formulas table containing the formulas matching the selection criteria.
Color-coding provides you with a visual indication of the formula status and the revision status as follows:
Formula status: o Draft = gray .
o
Active = green .
o Inactive = red .
o
Removed = black .
Revision status: o
Draft = gray .
o Current = green .
o
Outdated = black .
To view formulas: a cobas 8000 data manager Test Configuration > Formulas > List
1 If the filters in the Selection parameters group box are not visible, click the + to display them.
2 Select the appropriate formula and revision filters to display the formulas that you want to view and click Select . The formulas matching your selection criteria are listed in the formulas table.
Viewing formula logs
Each time a formula is run it is allocated a Run No.
, which increments each time the formula is run. A log is generated each time a formula is run. The Log subcomponent enables you to view the logs of formulas.
By using the selection filters provided you can choose to view the logs of formulas by period of time, by formula, by run number, or by any combination of these.
You also have access to formula definitions and the formula history from the Log sub-component.
Tip
The logs of a formula can also be accessed from the Formula definition dialog box by clicking Log .
To view the logs of formulas:
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Formulas a cobas 8000 data manager Test Configuration > Formulas > Log
1 If the filters in the Selection group box are not visible, click the + to display them.
2 Select the appropriate filters to display the logs that you want to view and click
Select . The logs matching your selection criteria are listed in the logs table.
Tip
You can view logs for a specific formula by entering the Formula No.
and pressing
Select . All logs for formula specified are listed in the logs table.
To view logs for a specific formula from the logs table, right-click a log of the formula that you want to view, and then click Show formula log on the shortcut menu. All logs for formula specified are listed in the logs table.
Viewing formula histories
Tip
To view the definition of a formula from the logs table, right-click a log of the formula whose definition you want to view, and then click Show formula definition on the shortcut menu. The Formula definition dialog box opens containing the definition of the formula selected. Note that you can only view the revision.
To view the history of a formula from the logs table, right-click a log of the formula whose history you want to view, and then click Show formula history on the shortcut menu. A dialog box opens containing the history of the formula selected.
history are available to view.
Some log entries do not belong to a formula and therefore no formula definitions and
The History sub-component lists the histories of all formulas.
The history of a formula records each status change of a formula and its revisions as an entry in the history table, indicating when the status change occurred, and which user made the change.
To view the history of a formula and a specific revision: a cobas 8000 data manager Test Configuration > Formulas > History
1 Right-click an entry of the formula whose history you wish to view, and then click
Show formula history on the shortcut menu. The History of formula dialog box opens containing all history entries of the formula selected.
2 To view a revision of the formula, in the dialog box right-click the revision you want to view, and then click Show revision on the shortcut menu. The Formula definition dialog box opens containing the details of the revision of the formula selected. Note that you can only view the revision.
Tip
Some history entries (e.g. ‘activation’) are only rule-specific and not revision-specific.
Consequently, no revision number is displayed, and the shortcut menu option Show revision is unavailable.
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Tip
You can view a revision of a formula directly from the history table by right-clicking on the revision of a formula that you want to view, and then clicking Show revision on the shortcut menu.
Formula settings
To enhance the legibility of formula rules created in the Formula definition dialog box, the Settings sub-component enables you to define the appearance of the mathematical notations used ( Math tree in the Formula definition dialog box).
e
For information on formula creation and rules see Creating a formula (p. C-90).
You are able to define the appearance of a mathematical notation in terms of the shape of the frame that surrounds it, color of the frame, and the background color in the frame.
To define the appearance of a mathematical notation: a cobas 8000 data manager Test Configuration > Formulas > Settings
1 In the settings table, right-click the mathematical notation whose appearance you want to define, and click one of the following commands on the shortcut menu: o Set background color to define the background color of the mathematical notation.
o Set frame color to define the color of the mathematical notation frame.
o Select shape , if available, to select the shape of the frame that surrounds the mathematical notation.
Tip
If you want to reset the frame and background colors to no color, on the shortcut menu select Reset frame color or Reset background color respectively.
Managing comment texts
Comment texts are used in different contexts (areas) within the data manager: o Samples o Tests o Results o Quality control
The Comment text groups component enables you to create and manage comments
(text blocks) that can used in these contexts.
When the comments texts are used "in context" (e.g. adding a comment to a test), they are added using the corresponding comment dialog box in which the comment texts are available from drop-down lists.
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Managing comment texts e
For more information see Adding comments to a test (p. C-32).
There are three main parts to creating comment texts:
1. Create comment groups (normally related to the contexts outlined above) into which comment texts can be added.
2. Assign the comment groups to the appropriate context ( Comment context ).
3. Create comment texts and add them to the appropriate comment groups.
The assignment of the comment groups to contexts ensures that only the relevant comments are available when you are adding them in a particular context (i.e. you only have test-related comments available when adding comments to tests).
Adding a comment group
Comment groups are used to group together common comment texts. There are three default comment groups that are pre-configured: o All comments : contains text comments (i.e. the content all comment groups).
o
Not assigned : contains text comments not assigned to a comment group.
o QC : contains text comments to be used in quality control.
These comment groups are not editable (in terms of their name, description and position). Comment groups that you create are editable.
To add a comment group: a cobas 8000 data manager Test Configuration > Comment text groups
1
Right-click in the comment groups table (top), and then click Insert group on the shortcut menu. The Comment group dialog box opens.
2
Type in the appropriate group name and description for the comment group.
3
Enter the appropriate value in Position . The value will determine the position of the comment group’s entry in the comment groups table. The lowest value has the highest position in the table.
4
You can:
Click Apply to save the comment group and add further comment groups.
Click OK to save the changes and to close the dialog box. The new comment group (s) appear as entries in the comment groups table.
Assigning context to a comment group
Having created a comment group you must indicate the context in which you want the comment texts contained in the groups to be used. You do this by assigning the corresponding comment group to the context.
The areas are listed in the comment context table (below the comment group table).
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Managing comment texts cobas ® 8000 modular analyzer series a cobas 8000 data manager Test Configuration > Comment text groups
1 In the comment context table, double-click the context to which you want to assign a comment group. The Comment group assignment dialog box for that context opens.
The dialog box contains two tables. The Not assigned comment groups table contains comment groups not assigned to this context. The Assigned comment groups table contains comment groups assigned to this context.
2 To assign a comment group to the context, in the click on the Not assigned comment groups table, click the comment group that you want to assign and click the >> button. The comment group moves to the Assigned comment groups table.
3
Repeat step 2 for as many comment groups as you need to assign to the context.
If you need to unassign a comment group, click it in the Assigned comment groups table, and click the << button.
4 When you have assigned the comment group(s) click Close . The Comment group assignment dialog box closes
Creating a comment text
Having created the comment groups and assigned them to the appropriate contexts, you can create comment texts for the appropriate comment groups.
Tip
You can create text comments in the All comments and the Not assigned comment groups, but must use the Group drop-down list to assign them to the appropriate comment group.
To create a comment text: a cobas 8000 data manager Test Configuration > Comment text groups
1 In the comment groups table, double-click the comment group to which you want to add a comment. The Comment texts dialog box opens.
2
Right-click in the comments texts table, and then on the shortcut menu click
Insert comment text . The Comment texts dialog box opens.
Note that the Group drop-down list defaults to the comment group that you double-clicked, and does not require selecting.
3
Enter an appropriate Text code for the comment text.
4
In Comment text type in the comment.
5
You can:
Click Apply to save the comment text and add another one.
Click OK to save the comment text and close the dialog box.
The new comment texts appear in the comment texts table.
6
Close the Comment texts dialog box.
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System configuration
23 System configuration
Table of contents
The majority of activities undertaken in the cobas 8000 data manager System
Configuration workplace components are applicable to Roche Field Service
Engineers only. This chapter looks at the activities undertaken in the System configuration and the Log files components.
In this chapter Chapter
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Data cleanup (data manager)
Data cleanup (data manager)
The Cleanup options tab in the System configuration component enables you to determine how long (in days) data is kept on the data manager.
The data categories for which you can specify retention periods are: o LIS messages and log entries.
o
Results.
o QC data.
o
Alarm data.
Data can be removed from the data manager automatically by specifying the time period you want it to be kept. When this time period has elapsed the data is removed automatically.
Tip
Only data that has been moved to TraceDoc, and is not part of an open order or an active
QC control will be removed.
You can also remove data manually.
Automatic data cleanup
You can configure the automatic cleanup by setting the data cleanup time periods on the Cleanup options tab in the System configuration component. Unless you specify otherwise, the default time period is 10 days for each category of data.
Tip
If you set a data category time period to zero, data in that category will not be removed by the automatic cleanup.
To configure an automatic data cleanup: a cobas 8000 data manager System Configuration > System configuration
1
On the Cleanup options tab, for each of the data categories, type in the appropriate time period (days) for which you want data to be kept.
2
Click OK .
Manual data cleanup
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You can manually start a cleanup using the Start cleanup button on the Cleanup options tab in the System configuration component. When you click the button the cleanup starts (i.e. data is cleaned up based on the time periods).
Tip
If you set a data category time period to zero, all data in that category will be removed when you click Start cleanup .
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Using log files
Using log files
cobas ® 8000 modular analyzer series
The Log files component helps you troubleshoot by enabling you to view system and user errors.
The log files are divided into the different categories (applications) based on the cause of the error.
Filters enable you to determine the log files that you view: o Application o
Log date from / Log date to o Type (Log type: information, warning, error, flag) o
Content (free text) o Only not seen (allows you to filter out entries already seen)
You can flag log files as reviewed, and can delete them
Viewing log file details
To view a log file and mark it as reviewed: a cobas 8000 data manager System Configuration > Log files
1
Use the filters to determine the log files that are listed in the log files table.
2
Right-click the log file you wish to view, and then click Display log info on the shortcut menu. The Log information dialog box opens containing the corresponding log file information.
3
After you have read the log file, close the Log information dialog box.
4
Optionally you can right-click on the log file, and then click Set reviewed on the shortcut menu. The corresponding Reviewed check box in the log files table is selected. The log file will not be listed when the Only not seen check box is selected.
Deleting a log file
To delete a log file: a cobas 8000 data manager System Configuration > Log files
1
Use the filters to determine the log files that are listed in the log files table.
2
Right-click the log file you wish to delete, and then click Delete on the shortcut menu. The log file is removed from the log files table.
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24 Administration
Table of contents cobas ® 8000 modular analyzer series
Administration
You use the cobas 8000 data manager Administration workplace to manage how the data manager will be used in terms of workplaces and components and user access, together with general system configuration.
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Managing workplaces
Managing workplaces
The Workplaces component enables you to manage the workplaces in the data manager. You can define workplaces and assign components to them.
Tip
Components can be assigned to more than one workplace.
The workplaces defined in the Workplaces component can be assigned to users in the User component. They are then available to the users on the Workplaces menu.
e
For more information see Assigning workplaces to a user (p. C-109).
The data manager comes with pre-defined workplaces: o cobas 8000 data manager Routine o cobas 8000 data manager QC Parameters o cobas 8000 data manager QC Routine o cobas 8000 data manager Routine Configuration o cobas 8000 data manager Test Configuration
Tip o cobas 8000 data manager System Configuration o cobas 8000 data manager Administration o cobas 8000 data manager Service
You can re-configure these to suit the needs of your organization.
There are two ways in which you can view existing workplaces:
When you click the Workplaces component in the navigation tree, the workplaces are displayed in the work area.
When you double-click the Workplaces component in the navigation tree, the workplaces are displayed as sub-components. Clicking one displays the components assigned to it in the work area.
Adding a workplace
To add a workplace to the data manager: a cobas 8000 data manager Administration > Workplaces
1 Right-click in the workplaces table, and then click Insert workplace on the shortcut menu. The Workplaces dialog box opens.
2 Enter the appropriate Workplace ID , Name and Description .
3 To add the workplace to the data manager, click the dialog box close button. A message is displayed asking if you want to save the modified data. Click Yes . The workplace is added to the workplaces table.
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Assigning components to a workplace
To assign components to a workplace: a cobas 8000 data manager Administration > Workplaces
1
In the workplaces table right-click the workplace to which you want to assign components, and then click Edit workplace on the shortcut menu. The
Workplaces dialog box opens.
2
Right-click in the components table (lower portion of the dialog box), and then click New assignment component on the shortcut menu. The Assignment component - workplace dialog box opens.
3
From the Component drop-down list, select the component you want to add to the workplace. The corresponding Language settings are automatically displayed.
4
In Parameter enter a number representing the position you want the component take when it is displayed below the workplace in the navigation tree. For example, entering 1 will locate the component immediately beneath workplace, 2 will locate it second and so on.
5
Click OK . The component is displayed in the components table of the
Workplaces dialog box.
6
Repeat steps 2 to 5 for every additional component that you wish to assign to the workplace.
7
When you have finished assigning the components to the workplace, close the
Workplaces dialog box.
Editing a workplace
You can edit a workplace in terms of assigning or unassigning components, or by editing a component’s assignment. (e.g. re-arranging the position of the components in the navigation tree).
a cobas 8000 data manager Administration > Workplaces
1
In the workplaces table right-click the workplace you want to edit, and then click
Edit workplace on the shortcut menu. The Workplaces dialog box opens.
2
Do one of the following: o
To unassign a component from the workplace, right-click the component, and then click Delete assignment on the shortcut menu. The component is removed from the components table.
o To edit the assignment of a component to the workplace, right-click the component, and then click Edit assignment on the shortcut menu. The
Assignment component - workplace dialog box opens in which you can make the appropriate amendments and then click OK .
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Managing users
24 Administration
Managing users
You use the User component to create and manage users together with their personal access permissions. Each user is individually assigned workplaces, icons, and permissions (including SOP maintenance) in addition to the user name and password.
Tip
Most of the changes to the user configuration will not become operational until after a new logon.
Adding a user
Editing a user
When you add a user to the data manager you define their system access permissions.
a cobas 8000 data manager Administration > User
1 Right-click in the users table, and then click Insert user on the shortcut menu.
The User ID dialog box opens.
2 Enter the appropriate details for the user that you are creating and click Save . The
User ID dialog box closes and user is added to the users table.
To edit a user: a cobas 8000 data manager Administration > User
1 In the users table right-click the user that you want to edit, and then click Edit user on the shortcut menu. The User ID dialog box opens.
2 Make the appropriate modifications and click Save . The User ID dialog box closes and user is updated.
Assigning workplaces to a user
By assigning workplaces to a user, you determine the data manager workplaces to which they have access.
The user will see the workplaces that have been assigned to them on the Workplaces menu on the data manager menu bar.
To assign workplaces to a user:
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Managing users cobas ® 8000 modular analyzer series a cobas 8000 data manager Administration > User
1 In the users table right-click the user to whom you want to assign workplaces, and then click Modify workplace on the shortcut menu. The User/Workplaces dialog box opens.
2 Right-click in the workplaces table (lower portion of the dialog box), and then click Insert workplace on the shortcut menu. The Assignment user - workplace dialog box opens.
3 On the Workplace drop-down list, click the workplace you want to assign to the user. This is a mandatory entry.
4 Enter the appropriate detail. The name that you enter in Title appears on the information bar when the user accesses the workplace. The number that you enter in Position determines the position of the workplace on the Workplaces menu.
5 Click OK . The Assignment user - workplace dialog box closes and the workplace is added to the workplaces table.
6 Repeat the previous steps for each workplace you want to assign to the user.
7 When you have finished assigning the workplaces to the user, close the
User/Workplaces dialog box.
Assigning icons to a user
Icons provide you with shortcuts to frequently used components or sub-components
(targets). Icons are located on the icon bar. Clicking an icon opens the target in a dialog box.
Additionally you assign icons to users. In doing so you can define the: o
Icon used.
o Icon’s target (component or sub-component).
o
Position of the icon on the icon bar.
o Size and position of the dialog box containing the target.
Icons are configured in the Icons component.
e
For more information see Editing user password profiles (p. C-115).
The data manager is delivered with a number of icons which can be used when configuring access to: o LIS Backup .
o
Technical validation .
o Day list .
o
QC Routine .
o Sample overview .
o
Test mask overview .
To assign an icon to a user: a cobas 8000 data manager Administration > User
1 In the navigation tree, double-click the user to whom you wish to assign an icon.
2 In the navigation tree, click Icons .
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Managing users
3 Right click in the icons table, and then click Insert icon on the shortcut menu.
The Assignment user - icons dialog box opens.
4 From the Icon drop-down list, select an icon.
5 Enter the appropriate detail for the icon that you are assigning:
Name is the icon name that appears below the icon on the icon bar.
Position determines where the position of the icon on the icon bar.
Title is the name that appears on the title bar of the dialog box.
Top , Left , Height and Width determine the size and location of the dialog box.
6 When all detail has been entered click OK . The icon is added to the icons table of the user.
Tip
The user must log out of the data manager and log back in before the icon is visible on the icon bar and available for use.
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Table of contents cobas ® 8000 modular analyzer series
Service
This chapter provides information for Roche Service Engineers, as well as for other users that might be given the relevant access rights.
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25
8000 data manager ............................................................. C-117
Determining when and where a system message appears................................. C-123
Determining the position of a system message ............................................ C-123
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Password profiles
Password profiles
The Password profiles component is used to govern the behavior of data manager users’ passwords. The password profile is global in that its settings apply to all data manager users.
The profile determines a password’s: o Password life time (days) : number of days for which a password is valid.
o
Password extension time (days) : number of days after the expiration of a password in which the user can change the password, after which the user cannot log in.
o Failed login attempts : number of times the user can enter their password incorrectly, after which the user cannot log in.
o
Password reuse time (days) : number of days before which a password can be used again.
o Password reuse max : number of passwords that must be used after the expiry of a password, before it can be used again.
Note that the options described above act in conjunction with each other.
The password life time and password extension time determine the maximum length of time that a password can be used.
The password re-use time and the password re-use max. determine when a password may be used again.
Applying a value of -1 to any of the options makes their value "unlimited". The default values for all options is -1, meaning that unless the value is changed, users’ passwords will not expire.
Editing user password profiles
To edit a user password profile: a cobas 8000 data manager Service > Password profiles
1
In the password profiles table, right-click the password profile, and then click Edit profile on the shortcut menu. The Password profile dialog box opens.
2
Make the appropriate changes and click Save . The Password profile dialog box closes.
Working with instruments
The Instrument component enables you to assign the tests which are performed on the cobas 8000 instrument.
Samples can be assigned in batches for testing on specific instruments.
In addition to assigning tests, you can store additional test-area-specific information or warnings such as flags and interface settings.
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Editing instrument flags
The instrument flag codes provided in this component are also printed on a test result report.
To edit an instrument flag: a cobas 8000 data manager Service > Instrument flags
1
In the instrument flags table, right-click the instrument flag that you want to edit, and then click Edit flag on the shortcut menu. The Edit instrument flag dialog box opens.
2
Edit the flag description as required.
3
Click OK to save the changes and close the dialog box.
Adding an instrument group
The Instrument groups component enables you to assign instruments to the data manager. These groups are then available as sub-components in the Day list and
Technical validation components in the cobas 8000 data manager QC Routine workplace.
It is possible to add and edit an instrument group. However, since instrument groups are normally defined during the initial installation and configuration of the system, we recommend that you do not edit them thereafter.
To add an instrument group: a cobas 8000 data manager Service > Instrument groups
1
Right-click anywhere in the instrument groups table, and then click Insert instrument group on the shortcut menu. The Edit instrument group dialog box opens.
2
Enter the appropriate values in Group and Name . Click Apply .
3
To add an instrument to the instrument group, right-click in the instruments table, and then click Insert instrument on the shortcut menu. The Assignment instrument group - instrument dialog box opens.
4
From the Instrument drop-down list and click the instrument that you want to add.
5
To assign additional instruments to the instrument group click Apply and repeat the previous steps.
6
When you have assigned the instruments click Cancel . The Assignment instrument group - instrument dialog box closes and the instruments are added to the instruments table in the Edit instrument group dialog box.
7
Click OK . The Edit instrument group dialog box closes and the instrument group is added to the instrument groups table.
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Icons used in the cobas
®
8000 data manager
Editing an instrument group
You can edit an instrument groups’s name, and add or delete instruments.
To edit an instrument group: a cobas 8000 data manager Service > Instrument groups
1
In the instrument groups table, right-click the instrument group that you want to edit, and then click Edit instrument group on the shortcut menu. The Edit instrument group dialog box opens.
2
You can add or delete instruments from the instrument group: o
To add an instrument to the instrument group repeat the appropriate steps in
the Adding an instrument group (p. C-116) procedure above.
o To delete an instrument from the instrument group, in the instruments table, right-click on the instrument that you want to delete and click Delete instrument . The instrument is removed.
3 Click OK . The Edit instrument group dialog box closes.
Deleting an instrument group
To delete an instrument group: a cobas 8000 data manager Service > Instrument groups
1 In the instrument groups table, right-click the instrument group that you want to delete, and then click Delete instrument group on the shortcut menu. A confirmation message box opens.
2 Click OK . The instrument group is removed from the instrument groups table.
Icons used in the cobas ® 8000 data manager
Icons are displayed on the icon bar and provide a shortcut to frequently used components and sub-components.
The Icons component enables you to view the available icons. The icons in this component can be individually assigned to a user and be linked with a selectable target in the User component.
e
For more information see Assigning icons to a user (p. C-110)
The icons provided in the data manager give access to: o
LIS Backup .
o Technical validation .
o
Day list .
o QC Routine .
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Defining patient genders cobas ® 8000 modular analyzer series o Sample overview .
o
Test mask overview .
These icons are provided with the intention to be assigned to users and provide short cuts to the corresponding components / sub-components.
Additionally a question mark icon and an exclamation mark icon are provided together with red, yellow and green system state icons. The latter are used in the
Information window , but can also be assigned to users and appear on the icon bar.
Defining patient genders
The Sex component enables you to configure the gender options, for example male, female or unknown, that are available to assign to patients.
Adding gender options for patients
To add a gender option: a cobas 8000 data manager Service > Sex
1 Right-click in the sex codes table, and then click Insert sex on the shortcut menu.
The Sex dialog box opens.
2 In Code , enter the abbreviation and in Sex , enter the description or name of the sex as required.
3 Click OK to save the entry and close the dialog box. Click Cancel to close the dialog box without saving the changes.
Editing gender options for patient
To edit a gender option: a cobas 8000 data manager Service > Sex
1 In the sex codes table, right-click the sex you want to edit, and then click Edit sex on the shortcut menu. The Sex dialog box opens.
2 Change the description to the sex as required.
Tip
You may not edit the code for the gender as it must correspond to the code used on the LIS.
3
Click OK to save the changes and close the dialog box. Click Cancel to quit the edit process and close the dialog box without saving the changes.
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Configuring priority statuses
Configuring priority statuses
The Priorities component enables you to manage all sample processing priority statuses used in your laboratory. These statuses can be selected when samples are registered in the LIS Backup component.
The samples and requests to be processed in the laboratory have different priorities.
For example, the sample of an emergency patient has a higher priority than a routine examination. The various priorities can be defined with priority codes.
In order to document the transfer of the result, you can also assign a special test to a priority (for example, Notify ward ) which is automatically included in the samples with this priority.
Tip
When the system is installed, it has the ‘ Routine ’ and ‘ STAT ’ (Short Turn Around Time) priority settings as default.
Editing priority codes
To edit a priority code: a cobas 8000 data manager Service > Priorities
1 Right-click the priority that you want to edit, and then click Edit priority on the shortcut menu. The Priority dialog box opens.
2 In the Name field, edit the long name for the priority, for example, change STAT to Emergency, as required in your laboratory.
Tip
You are not able to edit the priority code. You can only edit the name.
3 From the Color drop-down list, select a color, e.g. red for emergency. This color is used to highlight samples, for example, in the Sample overview component in the cobas 8000 data manager QC Routine workplace.
4 Click OK to save the changes and close the dialog box. Click Cancel to quit the edit process and close the dialog box without saving the changes.
Defining sample statuses
Sample statuses are used to document the progress of a sample from receiving it at the data manager to the release of its related test results, for example ‘All requests are still open’ or ‘Analysis and release completed’.
Sample status alerts can be color coded.
It is possible to edit the text that is displayed for a sample status, but these are generally defined during the initial installation and configuration of the system only.
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We recommend that you do not edit process status definitions after this initial configuration.
Editing a sample status
a cobas 8000 data manager Service > Sample status
1
In the sample statuses table, right-click the sample status you want to edit, and then click Edit sample status on the shortcut menu. The Sample status dialog box opens.
2
Change the name and description to the sample status as required.
3
Click OK to save the changes and close the dialog box.
Managing test statuses
The data manager includes default test statuses which advise laboratory staff at what point in the testing process an individual test is.
Tip
You can edit the test status descriptions, but we recommend that you do this only once after system installation. Subsequent changes to the test status descriptions should only be performed by an experienced and authorized staff member.
Editing test statuses
To edit a test status: a cobas 8000 data manager Service > Test status
1 In the test statuses table, right-click the test status that you want to edit, and then click Edit test status on the shortcut menu. The Test status dialog box opens.
2 Edit the status description according to your laboratory’s requirements.
Tip
Only enter a description which accurately reflects the meaning of the test status code.
3 Click OK to save the changes and to close the dialog box.
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Defining result statuses
Defining result statuses
The Result status component enables you to edit the test result description and how the information is displayed on the screen.
It is possible to edit a result status, but these are generally defined during the initial installation and configuration of the system only. We recommend that you do not edit result status definitions after this initial configuration.
Editing a result status
To edit a result status: a cobas 8000 data manager Service > Result status
1
In the result statuses table, right-click the result status you want to edit, and then click Edit result status on the shortcut menu. The Result status dialog box opens.
2
Change the name and description to the result status as required.
3
Click OK to save the changes and to close the dialog box. Click Cancel to quit the editing process and close the dialog box without saving the changes.
Real-time alarm configuration
The Real-time alarm configuration component enables you to create and remove alarm codes and sub-codes as necessary.
Configuring system messages
System messages are represented by colored icons and are contained in the
Information window . They provide a quick and visual indication of when action should be taken for the following situations: o Tests pending tech. validation (ROUTINE) : tests with a routine priority awaiting technical validation.
o
Tests pending tech val (STAT) : tests with a STAT priority awaiting technical validation.
o QC violations : tests which have QC violations.
o
Masked tests : tests which are masked (i.e. the tests are locked and cannot be sent to the instrument).
o Instrument flags : tests awaiting technical validation which have been flagged.
o
System information : system-related only information (hard disk space etc.).
o Pending calibrations indicates pending calibration requests.
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Configuring system messages cobas ® 8000 modular analyzer series o QC Standby bottle errors : Displays when there are QC Standby bottle errors and indicates the number. Double-clicking the system message opens the QC Standby bottles dialog box in which the errors can be located.
o
TraceDoc warnings : indicates when there is a TraceDoc warning. Doubleclicking the system message opens the TraceDoc warnings dialog box where you can view the log file associated with the warning.
o RAID information : Displays (red) when a RAID log has been generated. Doubleclicking the system message opens the RAID information dialog box where you can view the log file.
In almost all cases system messages provides quick access to the corresponding component or sub-component.
You can configure system messages to indicate the level of urgency in terms of the color of its icon: o Green - no action required.
o
Yellow - action might be required.
o Red - action should be taken.
The Information window component enables you to configure system messages in terms of: o Levels of urgency (color) of the system message.
o
Rules for when a system message is shown in the Information window .
o A system message’s position in the Information window .
o
Activating and deactivating a system message.
The available system messages are pre-determined, and you cannot add new or delete existing system messages. You can deactivate and activate system messages.
Editing system message parameters
The system message parameters enable you to define the rules determining the color of a system message icon. You define the value at which a system message icon changes from red to yellow, and the value when it changes from yellow to green.
To edit system message parameters: a cobas 8000 data manager Service > Information window > System messages
1 If they are not visible in the navigation tree, double-click System messages to display the system messages.
2 In the navigation tree, click the system message whose parameters you wish to edit. The Red > and Green < parameters are displayed in the work area.
3 Right-click the parameter you wish to edit, and then click Edit parameter on the shortcut menu. The Edit parameter dialog box opens.
4 Enter the appropriate value and click OK . The Edit parameter dialog box closes and the new value is entered in the Value column of the parameter.
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Configuring system messages
Determining when and where a system message appears
The active level and the sort value of a system message determine when and where it appears in the Information window .
Setting the active level of a system message
The Active level value of a system message determines when (i.e. which color icons) it is displayed in the Information window as follows: o Red : take action (red icon) only.
o
Yellow : action might be required (yellow icon), and take action (red icon).
o Green / All : no action required (green icon), action might be required (yellow icon), and take action (red icon).
Tip
When an active level value (i.e. red or yellow) means that a system message is not shown in the Information window , it is still running in the background and will be stored in the system messages overview.
This enables you ensure that you only see the system messages that interest you.
The active level value of a system message is displayed in the Active level column of the system messages overview table.
To change the active level values of a system message: a cobas 8000 data manager Service > Information window > System messages
1 In the system messages overview table, right-click the system message whose active level you wish to change, and then click Active level edit on the shortcut menu. The Active level dialog box opens.
2 From the Active level drop-down list, select the appropriate value and click OK .
The Active level dialog box closes.
3 The new active level value of the system message is displayed in the corresponding row of the Active level column in the system messages overview table.
The new active level value may mean that the system message is removed from the Information window (e.g. the system message icon is yellow and you change the active level to red).
Determining the position of a system message
The position of a system message in the Information window is determined by its sort value. The system message with the lowest sort value appears at the top of the
Information window and the system message with the highest sort value at the bottom.
The sort value of a system message is displayed in the Sort column of the system messages overview table.
To set the sort value of a system message:
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Configuring system messages cobas ® 8000 modular analyzer series a cobas 8000 data manager Service > Information window > System messages
1 In the system messages overview table, right-click the system message whose sort value you wish to change, and then click Active level edit on the shortcut menu.
The Active level dialog box opens.
2 In Sort , enter the appropriate value and click OK . The Active level dialog box closes.
3 The new sort value of the system message is displayed in the corresponding row of the Sort column in the system messages overview table.
The system message moves to the corresponding position in the Information window .
Activating / deactivating system messages
The activation status of a system message determines whether or not it is displayed in the Information window . A system message with a active status is displayed in the
Information window. A deactivated system will not.
Tip
Note that an activated system message may not be visible in the Information window because of its active level value.
The activation status of a system message is indicated in the Active column of the system messages overview table. A system message is active when the check box is selected.
To deactivate / activate a system message: a cobas 8000 data manager Service > Information window > System messages
1 In the system messages overview table, right-click the system message that you want to deactivate/activate, and then click one of the following commands on the shortcut menu:
Deactivate message to deactivate an active system message.
Or
Activate message to activate a deactivated system message.
For a system message that has been deactivated, its Active check box is deselected and the system message is removed from the Information window .
For a system message that has been activated, its Active check box is selected and the system message is added to the Information window .
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Table of contents cobas ® 8000 modular analyzer series
TraceDoc
TraceDoc is an application that is separate from the data manager, and is responsible for archiving activities.
In this chapter Chapter
26
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Introduction
26 TraceDoc
Introduction
TraceDoc receives and stores the data from the data manager that is required for long-term external archiving, and for upload to Roche via the TeleService-Net
(TSN).
Figure C-16 TraceDoc overview
You use TraceDoc to do the following: o
Trace data extraction and storage.
o Archiving trace data to external media (e.g. DVD, external hard drive).
o
Uploading trace data to Roche via the TeleService-Net (TSN). o Browsing current and archived trace data.
o
Trace data cleanup.
Data storage
Files to be archived are transferred from the data manager to TraceDoc every ten minutes. The time when this takes place is shown by Next process run input on the
TraceDoc tab of the Service-related configuration component in the Service workplace.
TraceDoc stores the files until they are transferred to TSN and archived to external media, for data that is older then the configured time span.
Archiving data to external media
TraceDoc creates off-line archives, normally to optical media.
You can configure data archiving to external media using the TraceDoc tab of the
Service-related configuration component in the Service workplace.
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Uploading data to TSN cobas ® 8000 modular analyzer series
Figure C-17 TraceDoc tab
You determine the time and frequency of an archive run using the: o Next archive run drop-down list to indicate when an archive takes place.
o Archiving interval field and drop-down list to determine the frequency of the archive (number of days / weeks / months between archives). The default setting is one week (1 W).
You indicate the destination of the archive by entering it in Archive destination . The default destination is the DVD drive (E:\).
If for any reason an archive fails to run (e.g. a DVD was not placed in the drive), an archive is automatically scheduled for the same time on the next day. This is shown in
Next emergency archive run .
Tip
You can use Notify before archiving to configure (in hours) when a reminder message will display if the archiving destination is unavailable (for example, there is no DVD in the destination drive). The default time is 10 hours.
When the archiving destination is available the message will not display.
You can start an archive run manually at any time by clicking Start archiving . The time at which the archive commences is shown in Next emergency archive run .
Uploading data to TSN
TraceDoc uploads data to the TSN every two hours. The time of the next upload to
TSN is shown in Next TSN upload run on the TraceDoc tab.
On the TSN agent tab of the Service-related configuration component, you can filter the data that is uploaded.
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Browsing data using the TraceDocViewer
Figure C-18 TSN agent tab
Selecting a filter means that the corresponding data will be sent to the TSN . The available filters are: o Patient results (no indication of patient identity is transmitted).
o Patient age and gender (no indication of patient identity is transmitted).
o Sample ID.
o Control results.
o Calibration information.
o Photometer check results.
o Events.
o Status log.
o Trace counter.
o Parameter transactions.
Browsing data using the TraceDocViewer
You use the TraceDocViewer to view trace data and can: o Browse different data types (traces).
o View related data.
o Perform related data searches.
o Print data.
You can browse data that is: o In TraceDoc.
o Archived on a DVD.
The TraceDocViewer functions in the same way in both cases.
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Browsing data using the TraceDocViewer cobas ® 8000 modular analyzer series
Starting the TraceDocViewer
To start the TraceDocViewer on your data manager client, click the ‘magnifying glass’ button on the Sidebar . The TraceDocViewer opens in the work area to the left of the Sidebar.
e
For more information see The Sidebar application (p. C-7).
To use the TraceDocViewer on a DVD containing archived data you must locate and double click the TraceDocViewer.exe
. In this case the TraceDocViewer opens, utilizing the whole screen.
Figure C-19
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TraceDoc viewer
The TraceDocViewer contains three main areas: o Looking for and Search criteria .
o Search result .
o Details .
You use Looking for and Search criteria to search for the data that you want to view.
The result of your search, or of subsequent ‘related data searches’ are listed in listed in
Search results .
Data for a selected result item, and data related to selected result item is viewed in
Details .
The function of each is explained in the following sections.
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Browsing data using the TraceDocViewer
Browsing data
You browse data in the TraceDocViewer using the Looking for drop-down list. The available data types are: o Samples.
o
QC control.
o Calibrations.
o
Reagents.
o ‘Others’ (trace types, e.g. calibration factors, instrument factors, photometer checks).
The criteria that you can use to search within a data type are listed in the Search
Criteria group box (beneath the Looking for drop-down list). For example, the available search criteria for ‘Samples’ are: o From / To dates .
o
Sample ID .
o Test code .
Additional group boxes of search criteria are listed beneath the Search Criteria group box: o Module .
o
Reagent .
o Calibration .
o
QC control .
The availability of the group boxes is dependant upon the data type that you have selected. For example, all group boxes are available for use for the data ‘samples’ type.
However, only Module and Reagent can be used for the ‘Calibrations’ data type.
Tip
The search criteria group boxes are ‘collapsed’ by default. Click ‘ + ’ to expand a group box view its content. Conversely, you can hide the content of a group box by clicking ‘ ’.
After you have selected the search criteria, click Find . The results of your search are listed in Search result .
Viewing result details and related data
After you have obtained the search results, you can view the result data and related data.
By clicking a result in Search results , you can view data related with the result in
Details and related data by clicking on the appropriate tab. The available tabs are dependant upon the data type you used in the search.
For example, if you searched using the ‘Samples’ data type, the available tabs are: o Sample details (shows the details of the sample selected).
o
QC control .
o Calibration .
o
Reagent .
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Data cleanup (TraceDoc)
Tip
Depending on the size of your monitor screen, all tabs may not be visible. Use the two arrows located to the right of the tabs to scroll and view hidden tabs.
Related-data searches
You can also perform searches based on data that is related to a search result. At the bottom of related data tabs is one (or more) search buttons with which you can perform a related-data search.
For example, you have performed a search for ‘Samples’, have selected a result in
Search results , and are looking at related-data on the Calibration tab.
You can use Find samples or Find controls located at the bottom of the tab to perform a search for the samples or for the controls (traces) which use the current calibration.
The result of the search is listed in Search results .
Printing
Tip
By clicking Print on the far right hand side of the TraceDocViewer , you can print the content of the Details tab that is currently visible.
To print related-data on other Details tabs, you must first click a tab to make its content visible.
Closing the TraceDocViewer
Click Exit to close the TraceDocViewer both when you are using it on the data manager client, and on an archive DVD.
When you are using the TraceDocViewer on the data manager client, you can switch from the TraceDocViewer to another application using the Sidebar . However it is advisable to exit the TraceDocViewer when you are not using it.
Data cleanup (TraceDoc)
Data is purged (deleted) from TraceDoc based on the length of time that it has resided on TraceDoc . Data is purged once a day.
You use Purge archived data older than ( TraceDoc tab of the Service-related configuration component, cobas 8000 data manager Service workplace) to configure the length of time (in months) that data remains on TraceDoc before it is purged. The default period is three months.
This is the last page of Part C .
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Maintenance
D
27 Safety information for maintenance . . . . . . . . . . . . . . . . . . . . . D-3
28 General maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-7
29 Maintenance of the core unit . . . . . . . . . . . . . . . . . . . . . . . . . . D-53
30 Maintenance (cobas ISE module) . . . . . . . . . . . . . . . . . . . . . . . D-67
31 Maintenance (cobas c 701 and c 502 modules) . . . . . . . . . . . . D-115
32 Maintenance (cobas e 602 module) . . . . . . . . . . . . . . . . . . . . . D-189
cobas ® 8000 modular analyzer series 27 Safety information for maintenance
Safety information for maintenance
Make sure that you have read and understood the chapter
. The following safety messages in particular are relevant:
Warning messages: o
Electrical shock from electronic equipment on page A-8
o
Infection from samples and associated materials on page A-9
o
Infection and injury due to sharp objects on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
Caution messages: o
Personal injury due to contact with moving parts on page A-11
Observe the system safety labels illustrated and described starting on page A-16.
WARNING
WARNING
Before performing any maintenance, read the following safety messages carefully. If you ignore these safety messages, you may suffer serious or fatal injury.
a Safety messages (overall system)
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in personal injury and infection. o Whenever possible, keep all covers of the analytical modules closed.
o Do not open a cover while the instrument is performing maintenance.
o When working with open covers while the instrument is powered on, always put the module in the appropriate maintenance mode first (e.g., power off).
o 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.
o If sample, reagent or other solution comes into contact with your skin, wash it off immediately with tap water and apply a disinfectant. Consult a physician.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
the following: T-1, T-8, T-9, T-13, T-14, T-15, T-16, F-2, F-4, F-6, F-7, F-13, F-16, R-1,
Fire and burns due to the use of alcohol
Alcohol is a flammable substance.
o Keep all sources of ignition (e.g. sparks, flames or heat) away from the instrument when conducting maintenance or checks using alcohol. o When using alcohol on or around the instrument, use no more than 20 mL at a time.
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CAUTION
NOTICE
CAUTION
WARNING
Malfunction due to spilled liquid
Any liquid spilled on the instrument may result in malfunction or damage of the instrument. o Do not place samples, reagents or any other liquid on the surface of the instrument.
o When removing and replacing the reaction cells, be careful not to spill water from the incubator bath.
o If liquid does spill on the instrument, wipe it up immediately and apply disinfectant. Be sure to wear protective equipment.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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. o Make sure no maintenance is being performed before supplying power to the instrument.
a Safety messages (cobas ISE module)
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.
o Only perform measurement, when the covers of the ISE measuring compartments are closed.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
a Safety messages (cobas c 701 and c 502 modules)
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. o Do not touch the piercer during cleaning.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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CAUTION
NOTICE a Safety messages (cobas e 602 module)
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.
o Only perform measurement, when the covers are closed.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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. o Use deionized water only to clean these parts of the instrument.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
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27 Safety information for maintenance cobas ® 8000 modular analyzer series
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General maintenance
Maintenance functions of the software
28 General maintenance
Table of contents
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 · Version 2.0
In this chapter Chapter
28
Extended power ON (after 1-2 days powered off) ....................................... D-27
Extended power ON (after 3-7 days powered off) ....................................... D-27
D-7
28 General maintenance
Table of contents cobas ® 8000 modular analyzer series
Maintenance schedules – weekly and longer intervals ...................................... D-43
Continuous operation and longtime power off .................................................. D-46
Performing background maintenance (module masking) ................................ D-50
Stopping background and parallel maintenance ................................................ D-51
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Overview
28 General maintenance
Overview
Personal injury or damage to the instrument due to non-observance of safety information o Before performing maintenance actions on any part of the instrument, read the safety notes for the corresponding maintenance item in the chapter
Safety information for maintenance on page D-3.
o 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.
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 core unit, ISE module, c 701 and c 502 module.
e See:
Maintenance of the core unit on page D-53
Maintenance (cobas ISE module) on page D-67
Maintenance (cobas c 701 and c 502 modules) on page D-115
Maintenance (cobas e 602 module) on page D-189.
All of the software submenus shown in Part
are used as examples only.
Your submenus may differ depending on your system setup.
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28 General maintenance
Overview cobas ® 8000 modular analyzer series
Maintenance concepts
Automation of maintenance tasks
Table D-1
Principle
Requirements
Scheduling of periodic maintenance intervals
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
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.
e See
Performing maintenance items on page D-18
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) e For more information on maintenance pipes, see:
Maintenance pipes on page D-19
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Overview
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 in Utility > System > Maintenance .
e For more information on defining and using maintenance types, see:
Defining and editing maintenance types on page D-28
Tracking maintenance on page D-30.
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 .
e
See Maintenance reports on page D-32
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.
e See
Background and parallel maintenance on page D-47.
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cobas ® 8000 modular analyzer series 28 General maintenance
Overview
Definitions
Maintenance item
A single maintenance procedure, such as (3) Photometer Check.
e For a list of maintenance items see
List of maintenance items on page D-33
Software-controlled maintenance
Maintenance items that are performed without operator interaction (such as Air
Purge). The software-controlled items are included in the maintenance types
Maintenance and Check under Utility > Maintenance .
Operator-controlled (manual) maintenance
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 D 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.
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.
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Interlock function
A
CAUTION
28 General maintenance
Overview
Some covers of the instrument are equipped with an interlock function that protects you from being injured by fast moving parts.
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.
o 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.
o Do not open an interlock cover during operation or maintenance. Mask the module first to put it in Standby. o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
c
c 701).
o
If you open one of these covers during Standby , an error message is displayed that the cover was opened.
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.
The following covers are monitored by the interlock function: o
ISE module: Top cover o c 701 module: Rear plexiglass cover around the sample probes o c 502 module: Top cover
B C
ISE
A Top cover
Figure D-1 c 701
B Rear plexiglass cover
Covers that are monitored by the interlock function c 502
C Top cover
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28 General maintenance
Overview cobas ® 8000 modular analyzer series a 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 .
Always execute a reset after using the interlock release tool. When it is possible that mechanisms have been moved, always execute a reset to return them to their home positions.
Instrument statuses for maintenance
CAUTION
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. o Before opening a cover for cleaning or maintenance, always check the instrument status. Make sure that no maintenance item is currently performed.
o 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.
o Make sure that the module is masked or the instrument is in Standby before executing a maintenance item or check.
o 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 Sampling Stop mode and then to Standby.
e For more information, see:
To perform background maintenance on page D-50
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Overview
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.
e For information about switching the instrument on and off, see:
To power off the instrument on page B-67
To manually start up the instrument on page B-49
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.
a 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 D-2 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. o Before replacing any parts, be sure to power off the instrument or the module.
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28 General maintenance
Overview cobas ® 8000 modular analyzer series
6 You may now perform any of the manual maintenance tasks listed in the maintenance schedules.
e
See: Combined maintenance schedules (all modules) on page D-41
a 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.
Wait at least for about one minute before resuming operation.
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Manual cleaning
28 General maintenance
Overview
The motors of the selected module are switched off. Use this item to move different parts manually for cleaning purposes, such as the pipetter probes, without having to power off the instrument.
a 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
Operator’s Manual · Version 2.0
Figure D-3 Manual Cleaning window
4
Select the desired module(s) and deselect all other modules.
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.
a To terminate Manual Cleaning mode
1
Choose Stop (global button).
2
Choose
Utility > Maintenance > (1) Reset .
3
Select the affected module and choose Execute .
4
On c 701 modules, perform a reagent registration via Reagent > Setting >
Reagent Registration .
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28 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.
e For information about the available maintenance items, see:
List of maintenance items on page D-33
List of maintenance checks on page D-38
a To execute a maintenance item
1
Choose Utility > Maintenance to display the Maintenance submenu.
Roche Diagnostics
D-18
Figure D-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.
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cobas ® 8000 modular analyzer series 28 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. e For more information, see:
Defining and editing maintenance pipes on page D-20
Recommended maintenance pipes on page D-26
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) e
Using maintenance pipe functions on page D-23
Example The Daily pipe
contains multiple maintenance items (Figure D-5). It can be executed
manually or be assigned e.g., to the Power Up Pipe function. In the latter case, the pipe function will automatically start the maintenance pipe at power-up.
Maintenance pipe
Manual execution
Daily pipe o
o
o
o
Automatic execution:
Maintenance pipe functions
Power Up Pipe function
Start Up Pipe function
Figure D-5 Example of maintenance pipes and maintenance pipe functions
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cobas ® 8000 modular analyzer series 28 General maintenance
Maintenance pipes
Note that: 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.
e See
Maintenance reports on page D-32
a To edit a maintenance pipe or to define a new pipe
1 Choose Utility > System > Pipe Settings to display the Pipe Settings window.
Figure D-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.
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Maintenance pipes
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-7 Edit window
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 loader. 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.
e See:
(16) QC Timer Reset on page D-36
(25) Urgent Information on page D-40
(26) Essential Information Upload on page D-40
(27) Database Backup on page D-40
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.
e For more information about the parameters of a specific maintenance item, please refer to the Online Help for that particular window.
7
Repeat steps 5 to 6 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.
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28 General maintenance
Maintenance pipes cobas ® 8000 modular analyzer series
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 > Power Up Pipe .
Performing maintenance pipes
The pipe must have been defined as a maintenance type first (see
Defining and editing maintenance types on page D-28).
a To execute a maintenance pipe
1 Choose Utility > Maintenance .
2
Follow the procedure to execute a maintenance item, see To execute a maintenance item on page D-18.
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.
Deleting maintenance pipes
a 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.
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Maintenance pipes
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.
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.
a To activate a Power Up pipe function
1
Choose Utility > System > Pipe Settings > Power Up Pipe .
Power Up Pipe window Figure D-8
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 rack loader (see: Setting the time switch on page B-214).
The analytical units will be initialized 10 minutes before the specified time. The maintenance pipe will be performed afterwards.
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28 General maintenance
Maintenance pipes
Start Up Pipe function cobas ® 8000 modular analyzer series
The Start Up Pipe function is used to automatically perform a selected pipe before the start of an analysis run.
a To activate a Start Up Pipe function
1
Choose Start (global button) or press the <F2> key to open the Start window.
Roche Diagnostics
D-24
Figure D-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.
Once the start up pipe begins, the setting changes back to Cancel .
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cobas ® 8000 modular analyzer series 28 General maintenance
Maintenance pipes
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.
a 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.
3
Choose Edit to display the Edit window.
Figure D-10 Edit window
4
Select the Power Off check box to activate the Power Off Pipe function.
The instrument will be powered off automatically after the pipe is completed.
e
See Recommended maintenance pipes on page D-26
5
Choose OK to save the settings and return to the Pipe Settings window.
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28 General maintenance
Maintenance pipes cobas ® 8000 modular analyzer series
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. e For information about maintenance pipes and maintenance pipe functions, see:
Maintenance pipes on page D-19
Defining and editing maintenance pipes on page D-20
Using maintenance pipe functions on page D-23
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).
Maintenance Item
ALL for
ISE, select Reagent for e 602 (1 cycle)
–
–
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.
Visual checks
With top covers closed, visually check that water is being
Module Page discharged at all rinse stations as well as through sample probes and reagent probes.
After air purge (in Standby mode), visually check the syringes
ISE c 701
and the tubing system for leakage and air bubbles.
c 701 c 502
ISE e 602 c 701 c 502
Table D-2
Check the photometer values via Print (global button) >
History .
Recommended maintenance pipe — Power ON
o Before starting routine operation, check that the incubator has reached the correct temperature (37 ± 0.1
° C) on the Overview menu.
It can take up to 30 minutes after an (5) Incubation Water Exchange for the incubator
to reach the correct temperature.
o If a green wash rack is processed in the Power On pipe, it is not necessary to perform
the maintenance item (8) Reagent Prime.
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Maintenance pipes
Weekly power off pipe
We recommend performing this maintenance pipe every week either before powering off or starting up ( Power Off Pipe function or Power Up Pipe function).
Module Maintenance Item c 701, c 502
(7) Wash Reaction Parts, NaOH-D pack (D1) required
Table D-3
Recommended maintenance pipe — Weekly
Page
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.
Extended power ON (after 1-2 days powered off)
Module e 602
Table D-4
Maintenance Item
(8) Reagent Prime, select W2 Sipper
(24) MC Preparation (5 cycles)
Extended power ON 1
Extended power OFF (for 3-7 days)
Module e 602
Table D-5
Maintenance Item
(8) Reagent Prime, select Reagent
(8) Reagent Prime, select W2 Sipper
Extended power ON 2
Extended power ON (after 3-7 days powered off)
Module e 602
Table D-6
Maintenance Item
(8) Reagent Prime, select Reagent
(8) Reagent Prime, select W2 Sipper
Extended power ON 2
Cycles
5
5
5
Cycles
1
5
-
1
5
10
Cycles
5
5
30
5
Page
Page
Page
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28 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.
a To edit a maintenance type or define a new type
1
Choose Utility > System > Maintenance Settings .
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Figure D-11 Maintenance Settings window
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cobas ® 8000 modular analyzer series 28 General maintenance
Maintenance types
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
3 Enter a name for the maintenance type in the text box at the top of the window.
A
Roche Diagnostics
Operator’s Manual · Version 2.0
A Name of a maintenance item or pipe
Figure D-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.
e 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 (see Maintenance reports on page D-32).
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.
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28 General maintenance
Maintenance types cobas ® 8000 modular analyzer series
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
Repeat steps 3 to 9 for all items of the maintenance type.
11 Choose OK to save the settings.
12 Choose Close to close the Maintenance Settings window.
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.
a To display the maintenance status
1 Choose Utility > Maintenance .
Figure D-13 Maintenance submenu
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Maintenance types
The right column displays the date the maintenance item or pipe was last performed. The following colors are used in this submenu:
Column
Maintenance
Type
Date/Time
Table D-7
Color Meaning
Yellow
Red
Yellow
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.
This maintenance item or pipe exceeded its warning level .
Red 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.
e For more information about the Maintenance Monitor window, refer to the Online
Help for that particular window.
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28 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.
a 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 .
2009/09/16 16:27
Power On Time
Operation Time
Maintenance Type :
Module :
Cell Detergent Prime
Date
* 2009/06/24
* 2009/06/23
* 2009/06/23
* 2009/06/22
* 2009/06/19
Time
Maintenance
C7-1
Operator ID
09:29:44 bmserv
17:31:00 SYSTEM
08:51:58 bmserv
06:39:55 SYSTEM
09:25:31 SYSTEM
06:39:04 SYSTEM
07:54:16 SYSTEM
08:54:06 SYSTEM
* 2009/06/18
* 2009/06/17
* 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
06:38:55 SYSTEM
06:39:02 SYSTEM
06:42:41
09:19:22
16:27:24
11:22:36
09:45:26
07:53:30
296
44
Operator ID: admin
Hours
Hours
Comment
Figure D-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.
e For more information about the Maintenance Report, please refer to the Online Help for that particular report.
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cobas ® 8000 modular analyzer series 28 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 502, e 602
Core
MSB
Denotes the module to which this maintenance item applies.
Core unit (rack loader/unloader and conveyor)
Module sample buffer
Injury due to contact with instrument mechanism
Contact with the instrument mechanisms during maintenance may result in personal injury.
o 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.
o Make sure that the module is masked or the instrument is in Standby before executing a maintenance item or check.
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 unloader.
(2) Rack Reset Core, MSB: Mechanical parts are reset to their home positions, all racks including
STAT racks are transported to the unloader. 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 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.
e See
To check the light intensity on page D-157.
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28 General maintenance
List of maintenance items cobas ® 8000 modular analyzer series
(4) Cell Blank Measurement c 701, 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 Abnormal Cell List . To view this list, choose
Print > History . e For information about the cell blank measurement, see:
To perform a cell blank measurement on page D-130
To view the cell blank measurement results on page D-130.
(5) Incubation Water Exchange c 701, c 502: Incubator bath water is exchanged and Hitergent is added. Incubator bath is also referred to as reaction bath (see also the abbreviation Reac.
on the
Overview menu).
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 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. e See
To perform an air purge (sample syringe) on page D-103 (ISE)
To perform an air purge (sample and reagent syringes) on page D-169 (
c 701, c 502)
(7) Wash Reaction Parts c 701, c 502: The reagent probes and all reaction cells are washed with detergent D1
(NaOH-D) from reagent packs (approx. 2
×
63 mL for c 701 and approx. 58 mL for c 502).
If you are running DAT assays, perform this item daily. For more information please refer to the package insert of the application on cobas link.
e See
To wash the reaction system on page D-130.
(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. e For the REF option, see:
To prime and calibrate the ISE module on page D-87
For the ALL option, see: To prime lines and check connections on page D-90.
e 602: The Pre-wash sippers and PreClean lines ( W2 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 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. e See
To perform a cell detergent prime on page D-148.
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cobas ® 8000 modular analyzer series 28 General maintenance
List of maintenance items
(10) Incubator Bath Cleaning c 701, c 502: Performs transition to Incubator Bath Cleaning mode: The photometer lamp is switched off and the incubator bath water is automatically drained.
On the c 701 module, press the F1 push button to terminate Incubator Bath Cleaning mode; on the c 502 module, choose Stop (global button). The reaction bath is automatically refilled with water and Hitergent is added.
e See
To remove reaction cells and to clean the incubator bath (c 502 module) on page D-142
To clean the surface of the ultrasonic mixer on page D-151.
(11) Manual Cleaning c 701, 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. Choose Stop (global button) or Cancel Maintenance (from the Overview menu) to terminate the Manual
Cleaning mode.
After manual cleaning, a reagent registration is required via Reagent > Setting >
Reagent Registration for c 701 modules.
e See
To put a module in Manual Cleaning mode on page D-17.
(12) Change Reaction Cell c 701, 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 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: Parameter settings are read from or written on a storage medium (CD or DVD).
e See
To save system parameters on a storage medium on page B-253
See
To restore system parameters to the system on page B-255.
(15) Test Count Write Core: Test count is written on a storage medium (CD or DVD).
Note: Insert the storage medium into the drive before
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28 General maintenance
List of maintenance items cobas ® 8000 modular analyzer series
(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.
(17) System Wash c 701: All reaction cells and reagent probes are washed with NaOH-D ( D1 ) from a reagent pack. The sample probes are washed with SmpCln 1 (basic wash) from the
68 mL container (approx. 300
μ
L).
e
602: Combination of maintenance items (19) Reagent Probe Wash, (20) Bead
Mixer Rinse, (21) e602 Reagent Wash, and (29) Pre-wash Sipper Rinse. This
combination is performed as many times as specified.
(18) Sample Probe Wash ISE, c 701 , c 502: The sample probes are washed with SmpCln 1 (basic wash) from the
68 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 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 water as many times as specified and then dried 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 is updated in the instrument software. For this purpose the AssayCups and 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.
This item can be performed in a power off pipe.
e For more information, see:
Power Off Pipe function on page D-25
To clean sample flow paths and ISE electrodes on page D-71.
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List of maintenance items
(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.
(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.
e For more information on the procedure, see:
(32) Empty PC/CC Reservoir e 602 (2:40): ProCell and CleanCell reservoirs are drained.
(33) Initial Bead Mixing e 602: Microbeads are mixed in each reagent pack for 15 seconds.
(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
o
o
(30) Pre-wash Sipper Air Purge.
(37) System Prime (e602) e 602: ProCell, CleanCell, and both Pre-wash lines are primed simultaneously.
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28 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.
o Program & Data : The report contains the names, sizes and date saved of the program and data files on the hard disk. The instrument software version is listed at the end of the report.
o
Extension : In addition to the previous option, this report includes the checksum of each file for error diagnosis by Roche service personnel.
(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. e See
To perform an ISE Check and calibrate the ISE units on page D-91.
(3) Mechanism Check All modules: Performs a functional check of mechanical parts of the selected module(s).
Deselect the SU check box to exclude all parts of the rack conveyor lines from this test. In this case, the Limit Cycles and Unlimited options are available. 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 (global button) to end this maintenance check. Or: Choose S.Stop to end this maintenance check and to move all racks to the unloader. Perform this check as needed after replacing the sample or reagent probe and after replacing the nozzle tips on the cell rinse nozzles.
e See
To perform a Mechanism Check on page D-113 (ISE)
To perform a Mechanism Check on page D-186 (
c 701 , c 502 )
(4) Probe Check c 701, 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 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.
Select Stop (global button) to stop the Probe Check.
e See
To check the horizontal alignment of a probe on page D-183
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cobas ® 8000 modular analyzer series 28 General maintenance
List of maintenance checks
(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.
Select Stop (global button) to stop the Probe Check.
e See
To check the horizontal alignment of a probe on page D-112
(6) Sample Barcode
Reader Check
Core, ISE, c 701, c 502 , e 602: Checks the sample barcode readers on the modules by scanning a rack with barcoded samples. After pressing Stop , the data are printed out for verification.
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. After pressing Stop , the data are printed out for verification.
Choose Print > History to view the results.
c 701 : The performance of the RFID readers is checked.
c
502: After starting the (7) Reagent ID Reader Check a reagent pack must be inserted
in the loading port. The gripper retracts the reagent pack automatically and the barcode reader reads in the barcode information on the cassette 5 times. Finally the reagent pack is ejected to the loading port and can be removed.
e 602: The barcodes of the loaded cobas e packs are scanned.
(8) R. Pack Loading Check c 502: The reagent pack loading mechanism is checked as well as the gripper and piercer movement. The check is performed according to input cycle (minimum:
5 cycles).
(9) Cuvette Mixing c 701, 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 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.
e See
To check the intensity of the ultrasonic output on page D-153.
(10) Reagent Short Sensor Check e 602: The sensors in the lines of the PreClean bottles, located on the inner side of the front door, 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.
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28 General maintenance
List of maintenance checks cobas ® 8000 modular analyzer series
(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.
(19) Pre-wash Gripper Check e 602 : The movement sequence and the AssayCup handling function of the Pre-wash gripper are checked.
(25) Urgent Information The data manager receives urgent parameters from Roche Diagnostics, such as urgent types of application, calibrator, and control parameters. When urgent parameters are available, the data manager creates a Urgent Information List and sends it to the control unit.
(26) Essential Information
Upload
This function saves necessary instrument information such as 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).
It is recommended performing this maintenance item every day. This maintenance item can only be performed in a maintenance pipe. Please contact either your Roche service representative or technical support to include Essential Information Upload in a maintenance pipe.
e For more information, see:
Defining and editing maintenance pipes on page D-20
Recommended maintenance pipes on page D-26
(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. In this case, please contact your Roche service representative or technical support.
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cobas ® 8000 modular analyzer series 28 General maintenance
Combined maintenance schedules (all modules)
Combined maintenance schedules (all modules)
CAUTION
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 based on a power-on time of 5 hours per day, 25 days per month . If the maintenance intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
o If your system power-on time is longer, you must create a customized maintenance schedule that matches your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types on page D-28.
The total power-on time is displayed on the Cumulative Operation List report. To view this report, choose Print > History > Cumulative Operation List .
WARNING
Symbols used in the maintenance schedules
– l
Infection and injury due to contact with instrument mechanism
Contact with the sampling mechanism or other mechanisms may result in personal injury and infection. o Whenever possible, keep all covers of the modules closed.
o Make sure that the instrument is in Standby before executing a maintenance item or check.
o 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).
This action is not performed or not available for this module.
This action is performed.
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28 General maintenance
Combined maintenance schedules (all modules) cobas ® 8000 modular analyzer series
Daily maintenance schedules
Instrument inspection – either before start-up or after poweroff
Procedure
Instrument inspection, including:
Check for any leakages
Unload all racks from the unloader
Turn on main water supply before shift.
Turn off if instrument is switched off and unused for more than 8 hours.
Load auxiliary reagents for the Daily pipe ( Power Up Pipe function)
Table D-8 Instrument inspection
Module l l l
Core ISE c 701 c 502 e 602 l l l l l l l l
– – – –
– – – – –
– – l l –
Page
Daily maintenance – at start up
(Daily pipe)
Items that can be performed in a daily Power Off pipe
Procedure Module
Core ISE c 701 c 502 e 602
ALL – l
ALL , 20 cycles
Table D-9
–
–
–
– l
Daily maintenance – at start up (Daily pipe)
Procedure
–
Module l
– l l l l
– l
–
–
–
–
Core ISE c 701 c 502 e 602 l
Table D-10
– l l
Items that can be performed in a daily Power Off pipe
–
Page
Page
Daily manual maintenance We recommend performing these actions after the working shift.
Procedure
Empty the concentrated waste container
Table D-11 Daily manual maintenance
Module Page
Core ISE c 701 c 502 e 602
– l l l
–
–
– l
–
– l
– l
–
–
– – – –
l
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cobas ® 8000 modular analyzer series 28 General maintenance
Combined maintenance schedules (all modules)
Maintenance schedules – weekly and longer intervals
Every two weeks
Weekly
Procedure
Table D-13
Module
Core ISE c 701 c 502 e 602
– l l l l
– – l l l
– – – – l
– – l l –
Washing the reaction parts, including item
– – –
– – l l l l –
Before power-off: Perform (4) Cell Blank
Measurement and check the cell blank
values under Print > History
– – – l l
– – – – l
D-195 Cleaning ProCell/CleanCell nozzles and replace reservoirs
Cleaning the mixing and separation stations
– – – – l
– – – – l
–
–
–
–
Module
–
–
Table D-12 Recommended weekly maintenance
Procedure
–
–
Core ISE c 701 c 502 e 602 l
l
Page
l
D-208 Cleaning the liquid flow path
– – – –
Page
Recommended maintenance – every two weeks
Monthly Procedure
Checking the ISE dilution vessel
Cleaning the ISE reagent aspiration filters
Replacing reaction cells and cleaning incubator bath
Cleaning the detergent aspiration filters
Module
Core ISE c 701 c 502 e 602
–
–
–
– –
Table D-14
–
Recommended monthly maintenance
– l l
–
–
– l l l
–
– l l l
–
–
–
–
–
Page
Every two months
Procedure
Replacing the Na, K and Cl electrodes
Table D-15
– l
Module
Core ISE c 701 c 502 e 602
–
Recommended maintenance – every two months
– –
Page
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28 General maintenance
Combined maintenance schedules (all modules) cobas ® 8000 modular analyzer series
Quarterly
Procedure
Cleaning the water inlet filters
Washing the ISE reagent flow paths
Replacing the ISE pinch valve tubing
Cleaning the ultrasonic mixers
Cleaning the filter of the air ionizer
Cleaning the filter of the solenoid valve
Replacing the pinch valve tubings
Table D-16
Module Page
Core ISE c 701 c 502 e 602 l – l l l
–
– l l
–
–
–
–
–
–
–
–
–
–
–
–
–
– l l l
– l
–
–
–
–
–
–
l
Recommended quarterly maintenance
Every six months
As needed
Procedure Module
Core ISE c 701 c 502 e 602
Replacing the ISE reference electrode
Emptying and cleaning the concentrated waste container
l
–
– l
–
– l
– l l
– l l l l –
Table D-17
Procedure
Recommended maintenance – every six months
Draining the tank of the deaerator and
– l
Module
Core ISE c 701 c 502 e 602 l – l –
– l
– l – l
–
–
Cleaning the ISE reagent aspiration filters
– l l l
– –
Cleaning the ISE dilution vessel
Replacing the pipetter probes – elimination of clogging
Cleaning the detergent aspiration filters
–
–
–
–
–
–
– l l l l l
– l l l l l
–
–
–
–
Replacing nozzle tips on cell rinse nozzles
–
– l
–
– l
–
–
–
l l l
Table D-18 Maintenance – as needed
Page
Page
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cobas ® 8000 modular analyzer series 28 General maintenance
Combined maintenance schedules (all modules)
Procedure
Cleaning ProCell/CleanCell stand and aspiration tubes
Cleaning ProCell/CleanCell aspiration tube filters
–
Cleaning the reagent disk and compartment
–
Module Page
Core ISE c 701 c 502 e 602
– – – – l
– – – l
Cleaning the solid waste compartment
Extended power OFF and ON procedures
Table D-18 Maintenance – as needed
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– l
l
l
l
e For detailed maintenance schedules of each module, see:
Maintenance schedule for the core unit on page D-55
Maintenance schedule for the cobas ISE module on page D-69
Maintenance schedule for cobas c 701 and c 502 modules on page D-117
Maintenance schedule for the cobas e 602 module on page D-191.
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28 General maintenance
Combined maintenance schedules (all modules) cobas ® 8000 modular analyzer series
Scheduling periodic maintenance tasks
Customized maintenance schedules
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.
The intervals for maintenance and checkup recommended in this document are based on a power-on time of 5 hours a day, 25 days a month. If your system's poweron time is longer, you must create a maintenance schedule, which is customized to your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types—scheduling and tracking maintenance items on page D-11.
Continuous operation and longtime power off
NOTICE
NOTICE
Precautions for continuous operation
If the instrument is used continuously (without power off) for 24 hours or more – for example, for STAT measurements at night – reset all maintenance intervals to meet the actual running hours of your system and use customized maintenance types to schedule your maintenance tasks.
e See
Maintenance types on page D-28.
Precaution for operation after longtime power off
If the instrument has been powered off for a week or more, check its performance before starting up operation again. For performance check details, consult your local service representative.
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cobas ® 8000 modular analyzer series 28 General maintenance
Background and parallel maintenance
Background and parallel maintenance
Background maintenance is used to perform maintenance functions on one or more modules while the instrument is still in Operation mode.
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 background or parallel maintenance; you must perform all maintenance items individually. e For more information, see:
Performing background maintenance (module masking) on page D-50
Performing parallel maintenance on page D-51
The tables on the following pages indicate the instrument status in which the maintenance items and checks can be performed.
Limitation for the left c 701 module
Background and parallel maintenance cannot be performed on the c 701 module closest to the ISE module when the ISE module is in Operation or in any maintenance mode.
Abbreviations used in the following tables
B
P l
SB
This item can be performed
Standby mode
Background maintenance (module is masked)
Parallel maintenance on different modules (system in Standby)
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Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series 28 General maintenance
Background and parallel maintenance
Maintenance Item
SB l
ISE
B l
P l
SB l c 701
B l
P l
SB l c 502
B l
P l
SB l e 602
B l
l l l l l l l l l l l l l a) l l l c) l l l l b) l l b) l l b) l l b) l l l c) l l a) l l b) l b) l b) l b) l l l l l l l l l a) l l l l l l l l l a) 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 l l l l l l l l l
l
(30) Pre-wash Sipper Air Purge
l l l l l l l l l l l l l l l l l l
Table D-19 Available operation modes for maintenance items a) Except for the sample probes b) This item cannot be performed on the c 701 module closest to the ISE module while the ISE module is in Operation or any maintenance mode.
c) This item cannot be performed on the c
701 module closest to the ISE module while the ISE module is in Operation mode or performing (2) ISE
l l l l l l l l l l l l l l l l l l l l l
P l
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cobas ® 8000 modular analyzer series 28 General maintenance
Background and parallel maintenance
Maintenance Check ISE
B c 701
B c 502
B e 602
B SB B SB P SB P SB
l l a) l l l a) l l l l l l l l l l l l l l l
l
(6) Sample Barcode Reader Check
l l l l l l l l l l l l l l l l l l l
(10) Reagent Short Sensor Check
(26) Essential Information Upload
Available operation modes for maintenance checks
Table D-20 l l l l l l l l l l a) This item cannot be performed while the c
701 module closest to the ISE module is performing (5) Incubation Water Exchange or (10) Incubator
l l l l l l l l l l l l l l l l l l l l l l
P
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28 General maintenance
Background and parallel maintenance cobas ® 8000 modular analyzer series
Performing background maintenance (module masking)
Use the following procedure to perform maintenance on one analytical module while the system is in operation.
a To perform background maintenance
1
Choose Start (global button) to display the Start window.
2
Choose Masking > Module Masking .
Roche Diagnostics
D-50
Module Masking window Figure D-15
3 Choose the modules to be masked. When a module is masked, it appears crossed out on the display.
4 Choose Execute to save the changes.
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.
e
See Background and parallel maintenance on page D-47.
The module can be masked/unmasked only when the instrument is in Standby or
Operation mode.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 28 General maintenance
Background and parallel maintenance
Performing parallel maintenance
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.
e See
Background and parallel maintenance on page D-47.
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.
Do not choose Stop (global button) to end background maintenance. This will stop all functions on all modules.
a To cancel 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 .
4 Confirm with OK to stop the action.
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cobas ® 8000 modular analyzer series 28 General maintenance
Periodic replacement of parts
Periodic replacement of parts
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. o Before replacing any parts, be sure to power off the instrument or the module.
e See
To power off a specific module on page D-15.
CAUTION
Incorrect results due to improper spare parts
For proper instrument function, use only original spare parts provided by Roche. o The necessary spare parts are listed in the description of the corresponding maintenance action.
o To order spare parts, please contact your Roche representative.
o When replacing parts (e.g., sample probe or nozzle tips), check their part numbers.
ISE module c 701 and c 502 modules
Item
Item
ISE measuring electrodes
(Na
+
, K
+
, Cl
-
)
ISE pinch valve tubing
Syringe seals
ISE reference electrode
ISE sample probe
As needed 2 months 3 months 6 months x (a) x x x (b) x
Table D-21
(a)
Periodic replacement of parts for the ISE module
Replace the ISE measuring electrodes after two months or after measuring 9000 samples.
(b)
Replace the ISE syringe seals after six months or after measuring 225 000 tests.
Page
As needed Monthly 3 months 6 months Page
Roche Diagnostics
D-52
Reaction cells x
Photometer lamp
Syringe seals x (a) x (b)
Nozzle tips of cell rinse unit
Sample and reagent probes x x
Table D-22
(a)
Periodic replacement of parts for the c 701/ c 502 module
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 .
(b)
Replace the syringe seals after six months or after measuring 225 000 tests.
e 602 module
Item As needed Weekly 3 months 6 months Page
Pinch valve tubings x (a)
Table D-23
(a)
Periodic replacement of parts for the e 602 module
Replace the pinch valve tubings after three months or after measuring 25,000 tests per measuring channel.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Maintenance of the core unit
29 Maintenance of the core unit
Table of contents
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
29
Draining the tank of the deaerator and water trap ............................................ D-64
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Operator’s Manual · Version 2.0
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29 Maintenance of the core unit
Table of contents cobas ® 8000 modular analyzer series
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cobas ® 8000 modular analyzer series 29 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 Page
Instrument status
PO
Weekly
Quarterly
Every six months
As needed
Table D-24
Cleaning the water inlet filters
Draining the tank of the deaerator and water trap
Maintenance schedule – core unit
PO
PO
PO
PO/SB
Instrument status (mode)
CAUTION
PO Power Off (or powered off on Utility > System Configuration > Module Settings ), see:
To power off a specific module on page D-15.
SB
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 based on a power-on time of 5 hours per day, 25 days per month . If the maintenance intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
o If your system power-on time is longer, you must create a customized maintenance schedule that matches your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types on page D-28.
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29 Maintenance of the core unit
Weekly maintenance
Weekly maintenance
cobas ® 8000 modular analyzer series
This section describes the maintenance action that must be performed at least once a week 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 week 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Malfunction due to spilled liquid on page D-4
a To disconnect a water tank
1 Power off the complete instrument or the individual module that uses the water tank.
e
See: To power off the instrument on page B-67
To power off a specific module on page D-15
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2 Turn off external water supply.
29 Maintenance of the core unit
Weekly maintenance
A
A Water tank
Figure D-16 Close the tap at the water tank
3 Locate the water tanks ( A ) at the rear of each module sample buffer.
4 Close the tap at the outlet of the water tank.
Roche Diagnostics
Operator’s Manual · Version 2.0
A
A Unlocked position
Figure D-17 Disconnecting the joint
5 Place paper towels under the joint to absorb spilled water.
6 Turn the ring to the unlocked position ( A ) of the joint.
D-57
29 Maintenance of the core unit
Weekly maintenance
7 Separate the joint.
A cobas ® 8000 modular analyzer series
Roche Diagnostics
D-58
A Liquid level sensor assembly
Figure D-18 Cleaning the liquid level sensor assembly
8 Lift the liquid level sensor assembly ( A ) from the tank and place the assembly on a
9 paper towel.
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 (see: To thoroughly clean the water tank on page D-58).
11 If the water is clear, rinse the tank with deionized water three times.
12 Reconnect the water tank (see:
To reconnect the water tank on page D-59).
a 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.
3 Reconnect the water tank (see:
To reconnect the water tank on page D-59).
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 29 Maintenance of the core unit
Weekly maintenance a 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 D-19 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. o Ensure that all joints are connected properly.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: S-3.
4 Open the tap.
5 Turn on external water supply.
6 Power on the instrument or module again, or continue performing other maintenance tasks.
e
See: To power on a specific module on page D-16
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Operator’s Manual · Version 2.0
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29 Maintenance of the core unit
Quarterly maintenance
Quarterly maintenance
cobas ® 8000 modular analyzer series
This section describes the maintenance actions that must be performed at least once every three months on the core unit.
Cleaning the water inlet filters
Clean the water inlet filters at least once every three 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. o Clean the filter regularly.
o Reconnect the water inlet hose to the water inlet manifold correctly.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in particular
a 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.
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D-60
Figure D-20 Disconnecting the water inlet cap
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 29 Maintenance of the core unit
Quarterly maintenance
3 Place a 500 mL beaker (or other appropriate container) beneath the water inlet manifold.
4 Turn the water inlet cap counterclockwise and disconnect the water inlet cap.
B
A
A Beaker
Figure D-21 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.
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29 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
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CAUTION
29 Maintenance of the core unit
Every six months maintenance a 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.
Therefore power off the instrument before cleaning.
A B
C
A Cooling fan of module sample buffer
B Cooling fan of ISE module
Figure D-22
C Cooling fan of core unit
Examples of cooling fans to be cleaned
2 Vacuum or brush dust, dirt, and other debris from all cooling fans at the rear of the instrument.
3 Power on the instrument or module again, or continue performing other maintenance tasks.
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29 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.
e This section discusses the following maintenance actions:
Draining the tank of the deaerator and water trap on page D-64
Cleaning instrument surfaces on page D-65
Draining the tank of the deaerator and water trap
A deaerator and a water trap are provided in the module sample buffer of each c 701 and e 602 module. If the connected tank is filled with water, it may affect the performance of the deaerator.
Drain the water when an alarm is issued.
Operator time approximately 1:30 minutes per module sample buffer
Materials required m Beaker a To drain the tank of the deaerator and water trap (c 701 / e 602)
1
Power off the complete instrument or the individual module to which the tank belongs.
Roche Diagnostics
D-64
Figure D-23 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 · Version 2.0
cobas ® 8000 modular analyzer series 29 Maintenance of the core unit
As needed maintenance
6 Power on the instrument or module again, or continue performing other maintenance tasks.
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)
NOTICE
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Damage to instrument surfaces
Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
a 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.
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Operator’s Manual · Version 2.0
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29 Maintenance of the core unit
As needed maintenance cobas ® 8000 modular analyzer series
Roche Diagnostics
D-66 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Table of contents
Maintenance (cobas ISE module)
Roche Diagnostics
Operator’s Manual · Version 2.0
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
30
Emptying and cleaning the concentrated waste container ............................... D-75
Replacing the ISE sample probe – elimination of clogging ............................ D-108
D-67
30 Maintenance (cobas ISE module)
Table of contents cobas ® 8000 modular analyzer series
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D-68 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Maintenance schedule for the cobas ISE module
Maintenance schedule for the cobas ISE module
Procedure
The following table lists all maintenance actions required for the ISE module:
Daily
Emptying and cleaning the concentrated waste container
Weekly
Monthly
Every two months
Quarterly
Checking the ISE dilution vessel
Cleaning the ISE reagent aspiration filters
Replacing the Na, K and Cl electrodes
(b)
Washing the ISE reagent flow paths
Replacing the ISE pinch valve tubing
Every six months
As needed
Table D-25
Replacing the ISE reference electrode
(c)
Cleaning the ISE dilution vessel
Replacing the ISE sample probe – elimination of clogging
Maintenance schedule – ISE module
(a) From any operational status, such as Standby or Rack Reception mode, or within a maintenance pipe.
(b) Replace the ISE measuring electrodes after two months or after measuring 9000 samples.
(c) Replace the ISE syringe seals after six months or after measuring 225 000 tests.
Instrument status
–
(a)
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM
SB/MM/PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
PO
SB/MM/PO
Page
Instrument status (mode)
CAUTION
PO
SB
MM
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 e
For more information, see: Instrument statuses for maintenance on page D-14.
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 based on a power-on time of 5 hours per day, 25 days per month . If the maintenance intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
o If your system power-on time is longer, you must create a customized maintenance schedule that matches your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types on page D-28.
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Operator’s Manual · Version 2.0
D-69
30 Maintenance (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.
e This section discusses the following maintenance actions:
Processing green wash rack on page D-70
Cleaning the ISE sample probe on page D-73
Emptying and cleaning the concentrated waste container on page D-75
Processing green wash rack
Each day at the end of analysis, process a green rack containing detergents and
Activator as described below. This is a combined maintenance procedure for the
ISE module and 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.
Roche recommends performing the cleaning of the flow paths and conditioning of the electrodes within a Power Off pipe or another maintenance pipe. Then you do not have to perform this maintenance task manually. If the Wash Rack check box is selected for a maintenance pipe and you load a green rack, this pipe is automatically started after the green rack is processed.
e See
Power Off Pipe function on page D-25
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) m SmpCln 1 (only required for photometric modules) m SysClean (ISE cleaning solution) m Activator (ISE conditioning solution) m NaOH-D ( D1 ) reagent packs (only required for c 701 modules)
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cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Daily maintenance
ISE reagent consumption approximately 54 mL internal standard (ISE IS) approximately 20 mL diluent (ISE DIL) approximately 17 mL reference electrode solution (ISE REF)
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
CAUTION
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.
o Fill a sufficient amount of Activator and SysClean into sample cups.
o Place the sample cups into the correct positions of the green wash rack.
o If an alarm due to insufficient volume of these solutions is issued, all ISE samples measured after the alarm must be rerun.
CAUTION
Incorrect results due to wrong calibration
After processing a green wash rack, all ISE tests must be calibrated.
o Do not load samples with ISE requests before you have checked the calibration and QC results for ISE.
a To clean sample flow paths and ISE electrodes
1 Place sample tubes into positions 1 to 3 on a green rack (wash rack).
1
2
3
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-24 Green rack with reagents
2
Pipet suitable amounts of auxiliary reagents into the sample tubes (see Table D-
D-71
30 Maintenance (cobas ISE module)
Daily maintenance cobas ® 8000 modular analyzer series
Rack pos.
Auxiliary reagent
1
2
3
SmpCln 1
SysClean
Activator
Cycles
5
15
15
ISE (2 units)
–
600
μ
L a)
600
μ
L a) c 701
700
–
–
μ
L c 502
350
–
–
μ
L
Table D-26 Required reagents per single module a) For an ISE module with one ISE measuring unit, only 300
μ
L of SysClean and Activator is required
(20
μ
L per cycle).
Ensure correct cup positions
Unless sample cups are positioned as instructed, neither sampling nor washing will be performed.
Number of wash cycles
We recommend the following number of detergent sipping cycles: 15 ISE cycles and
5 photometric cycles. These values should be set by your system administrator on
Utility > System > Wash Racks .
3 Place the green rack on the rack loader.
4 For c 701 modules only: Check the remaining amount of NaOH-D ( D1 ) reagent packs on the Reagent Overview menu. For washing the reagent probes 7600
μ
L of this detergent are required.
5 Choose Start (global button) and Start on the Start window.
If the instrument is already in an operational status, skip this step.
6 Calibrate the ISE units either prior to powering off the instrument or prior to beginning the next run. Perform a full calibration.
e
See To request an ISE calibration on page B-108.
If washing is interrupted for some reason, perform
followed by
(4) Cell Blank Measurement. Afterwards, perform (8) Reagent Prime
(ALL) (only required for ISE modules).
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D-72 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Daily maintenance
Cleaning the ISE sample probe
NOTICE
Each day at the end of analysis, clean the outside of the ISE sample probe to remove residual solution and precipitation.
When sample aspiration error occurs frequently or if an alarm for clogging of the sample probe occurs and is not reset after cleaning (maintenance item
Probe Wash ), the sample probe must be detached and clogging must be eliminated.
Probes must be replaced if they are bent or damaged. Positional adjustment is required after reattaching the probe.
e See
Replacing the ISE sample probe – elimination of clogging on page D-108
Operator time approximately 1 minute
Materials required m Alcohol (e.g., isopropyl alcohol or ethanol) m
Deionized water m Lint-free gauze pads m
Paper towel
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o
Interrupt of operation due to interlock system on page D-13
Damage to the probes
Do not bend or damage the lower end of the probes during cleaning. Move the arm gently.
Do not move it up or down.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-73
30 Maintenance (cobas ISE module)
Daily maintenance cobas ® 8000 modular analyzer series a 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.) e
See: Instrument statuses for maintenance on page D-14
2 Open the top cover of the module. Alarms are issued as this cover is monitored by the interlock function.
Roche Diagnostics
D-74
NOTICE
A
A Paper towel to cover the openings of the ISE dilution vessels
Figure D-25 Cleaning the outside of the sample probe
3 Do not allow alcohol to drip into the ISE dilution vessels. Therefore, cover the openings of the dilution vessels with a paper towel.
4 Move the pipetter probe by hand to an accessible position.
5 While holding the pipetter arm with one hand, wipe – from top to bottom – the outside of the probe with a gauze pad moistened with alcohol.
Damage to instrument surfaces
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.
6 Remove the paper towel from the ISE dilution vessels.
7 Close the top cover.
8 Delete any alarms concerning the opened cover.
9 Unmask the module, or continue performing other maintenance tasks.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Daily maintenance
Alignment and replacement of the sample probe
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.
e See:
Replacing the ISE sample probe – elimination of clogging on page D-108
To check the horizontal alignment of a probe on page D-112
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
Roche Diagnostics
Operator’s Manual · Version 2.0
D-75
30 Maintenance (cobas ISE module)
Daily maintenance cobas ® 8000 modular analyzer series a 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
D-76
A Waste container
B Hose
Figure D-26
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.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (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.
e This section discusses the following maintenance actions:
Cleaning the rinse stations on page D-77
Cleaning the ISE drain ports on page D-80
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 % Hitergent solution m
Deionized water
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o
Malfunction due to spilled liquid on page D-4
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
D-77
30 Maintenance (cobas ISE module)
Weekly maintenance cobas ® 8000 modular analyzer series a To clean the rinse station
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. Alarms are issued as this cover is monitored by the interlock function.
3 Move the pipetter probe to a position that leaves the rinse station easily accessible.
A
A Rinse station
Figure D-27 Cleaning the ISE rinse station
4
Using cotton swabs moistened with 2 % Hitergent solution, clean the inside of the rinse station.
Roche Diagnostics
D-78 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Weekly maintenance
NOTICE
Figure D-28 Cleaning the ISE rinse station
5
Inject about 10 mL of 2 % Hitergent solution into the rinse station.
Damage to instrument surfaces
Immediately clean the surface from any Hitergent spills.
6
Inject about 100 mL of deionized water into the rinse station.
7
Close the top cover.
8
Delete any alarms concerning the opened cover.
9
Unmask the module, or continue performing other maintenance tasks.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-79
30 Maintenance (cobas ISE module)
Weekly maintenance cobas ® 8000 modular analyzer series
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a 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.
B
A
Roche Diagnostics
D-80
A Outlets
B Drain ports
Figure D-29 Rinsing off crystals from the outlet
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Weekly maintenance
3 Apply deionized water to the drain ports ( B ) and the bottom of the outlets ( A ) to rinse off crystals.
A
CAUTION
A Drain plate
Figure D-30 Removing and cleaning the drain plates
4 If crystals are still present, remove the drain plates: o Loosen the thumbscrews of the drain plates ( A ).
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.
Do not touch the drain port components during operation.
5
Close the front door.
6
If the module was masked, unmask it.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-81
30 Maintenance (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.
e This section discusses the following maintenance actions:
Cleaning the ISE dilution vessel on page D-106
Cleaning the ISE reagent aspiration filters on page D-84
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: o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
D-82 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Monthly maintenance a 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. Alarms are issued as this cover is monitored by the interlock function.
3 Remove the covers of the ISE measuring compartments.
A B C C B
B Vacuum nozzle and retaining screw
A Dilution vessel
Figure D-31 Checking the dilution vessel
C 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.
e
See: Cleaning the ISE dilution vessel on page D-106
5
Close the ISE measurement covers if cleaning is not required.
6
Close the top cover.
7
Delete any alarms concerning the opened cover.
8
Unmask the module, or continue performing other maintenance tasks.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-83
30 Maintenance (cobas ISE module)
Monthly maintenance cobas ® 8000 modular analyzer series
Cleaning the ISE reagent aspiration filters
The aspiration filters are attached to the tube end 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
CAUTION
Before performing this maintenance action, observe the following safety precautions: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
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.
o When removing reagent aspiration tube from a reagent container, ensure the tube does not come into contact with other open reagent containers.
a 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.
3
Pull out the drawer with the reagent containers.
Roche Diagnostics
D-84 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Monthly maintenance
Figure D-32 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 · Version 2.0
A ISE reagent aspiration filter
Figure D-33 Cleaning the ISE reagent aspiration filters
6 Unscrew the filter from the tube end.
7 Clean and rinse the filter with deionized water.
D-85
30 Maintenance (cobas ISE module)
Monthly maintenance cobas ® 8000 modular analyzer series
A
CAUTION
A Correct
Figure D-34 Replacing the ISE reagent aspiration filters
8 Finally, screw the filter on the tube end and place it back into the container ( A ).
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.
o Insert the aspiration tube into the container all the way until its end touches the bottom of the container. o Do not bend the aspiration tube.
9 Replace the container.
10
Repeat steps 6 to 9 for each aspiration filter.
11 Close the front door.
12 Power on the instrument or module again, if necessary.
Roche Diagnostics
D-86 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Monthly maintenance a 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 .
4 Choose Select to open the Reagent Prime window.
Figure D-35 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. Investigate any problem caused by a failed calibration.
e
See To request an ISE calibration on page B-108.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-87
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every two months maintenance
Every two months maintenance
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.
e 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
×
30 cycles) approximately 8 minutes for ISE calibration
Materials required m Sodium (Na
+
) electrode (yellow) m Chloride (Cl
-
) electrode (green) m
Potassium (K
+
) electrode (red) m
O-rings (on the electrodes) m Lint-free gauze pads m
Forceps
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
D-88 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every two months maintenance a 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. Alarms are issued as this cover is monitored by the interlock function.
3 Remove the covers of the ISE measuring compartments.
A B
Roche Diagnostics
Operator’s Manual · Version 2.0
A ISE measuring electrodes
B Release lever
Figure D-36
C Metal clip
Replacing the measuring electrodes
C
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—watch your fingers.
6 To lock the lever, press the metal clip ( C ) 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.
Verify that the connecting part and the new electrodes are provided with O rings.
10
Insert new electrodes in the right color-coded position in the ISE measuring compartment.
D-89
30 Maintenance (cobas ISE module)
Every two months maintenance cobas ® 8000 modular analyzer series
11 To unlock the lever, pull it to the RELEASE position.
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.
15 If the module was masked, unmask it.
CAUTION a 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 one ISE module or both.
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.
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.
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.
10
Delete any alarms concerning the opened cover.
After installing new ISE electrodes, perform the following procedure to condition
the electrodes: To perform an ISE Check and calibrate the ISE units on page D-91.
Roche Diagnostics
D-90 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every two months maintenance a To perform an ISE Check and calibrate the ISE units
1 Choose Utility > Maintenance .
2 Select Check (2) from the left list.
3 Select
.
4 Choose Select to open the ISE Check window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-37 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:
Na + , K + , Cl -
Ref
±
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 D-27
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.
e
See To request an ISE calibration on page B-108.
D-91
30 Maintenance (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.
e This section discusses the following maintenance actions:
Washing the ISE reagent flow paths on page D-92
Replacing the ISE pinch valve tubing on page D-94
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: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
a To wash the ISE reagent flow paths
1
Ensure the instrument or the module is in Standby (by masking the module).
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 >
.
5 Choose Select to open the ISE System Wash window.
Roche Diagnostics
D-92 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Quarterly maintenance
CAUTION
Figure D-38 ISE System Wash window
6 Select one ISE module or both.
7 Choose Execute . After washing has been completed, an alarm requesting a change of the reagents is issued.
8 Pull the aspiration tubes from the SysClean solution. Rinse the filters with deionized water and dry them well.
9 Thoroughly remove the detergent from the surfaces of the tubes using gauze pads moistened with deionized water.
10 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.
o Insert the aspiration tube into the reagent container all the way until its end touches the bottom of the reagent container. o Do not bend the aspiration tube.
11 Follow instructions on screen. The instrument performs a reagent prime automatically.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-93
30 Maintenance (cobas ISE module)
Quarterly maintenance cobas ® 8000 modular analyzer series a 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.
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 If the module was masked, unmask it.
6 Calibrate the ISE module before processing routine samples. Investigate any problem caused by a failed calibration.
e
See To request an ISE calibration on page B-108.
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: o
Infection from samples and associated materials on page A-9
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
a 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. Alarms are issued as this cover is monitored by the interlock function.
3
Remove the covers of the ISE measuring compartments.
Roche Diagnostics
D-94 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Quarterly maintenance
A
B
CAUTION
A Pinch valve tubing
B Pinch valve
Figure D-39 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 ( B ). 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.
Always reinstall the covers of the ISE units after performing maintenance.
6 Close the covers of the ISE measuring compartments.
7 Close the top cover.
8 Delete any alarms concerning the opened cover.
9
Perform maintenance item (2) ISE Check (10 cycles).
e
See To perform an ISE check on page D-94.
10 Calibrate the ISE units before you resume routine analysis.
e
See To prime and calibrate the ISE module on page D-87.
Check connections!
Make sure no air bubbles enter the system from the connectors and there is no liquid leaking inside the ISE measuring units.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-95
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every six months maintenance
Every six months maintenance
In this section you will find the maintenance action for the ISE module that must be performed at least once every six months.
e This section discusses the following maintenance actions:
Replacing the ISE reference electrode on page D-96
Replacing the syringe seals on page D-98
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, 30 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: o
Infection from samples and associated materials on page A-9
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
D-96 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every six months maintenance a 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. Alarms are issued as this cover is monitored by the interlock function.
3 Remove the covers of the ISE measuring compartments.
Roche Diagnostics
Operator’s Manual · Version 2.0
A Metal clip
Figure D-40 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 to loosen the electrodes from the mounting block. The lever is equipped with a spring—watch your fingers.
6
To lock the lever, press the metal clip ( A ) near the REF electrode.
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 electrodes.
A
Verify that the connecting part and the new electrodes 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
To unlock the lever, pull it to the RELEASE position.
12
Set the lever to LOCK to fasten the electrode.
13
Reconnect the electrode cord to the electrode.
14
Close the top cover.
D-97
30 Maintenance (cobas ISE module)
Every six months maintenance cobas ® 8000 modular analyzer series
15 Delete any alarms concerning the opened cover.
16 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).
e For further instructions, see:
To prime lines and check connections on page D-90
To perform an ISE Check and calibrate the ISE units on page D-91
Replacing the syringe seals
Replace the syringe seals every six months or after 225 000 tests, whichever occurs first. Worn-out syringe seals can cause leakage and inaccurate pipetting.
o The procedure for replacing the syringe seals is the same for all syringes. Note, however that there are different spare parts for sample and reagent syringes.
o The figures in this section refer to an ISE reagent syringe as an example.
o Perform the entire seal replacement for the first syringe before starting with the next.
Do not dismount more than one syringe at a time because the internal parts of the syringes differ and may be easily mistaken with each other.
This maintenance comprises the following procedures and maintenance items:
3. To replace the syringe seals
5. To perform an air purge (sample syringe)
6. To prime lines (ISE IS, DIL, and SIP syringes)
7. To check syringe connections (all syringes)
Operator time approximately 6 minutes per syringe
System time
Roche Diagnostics
D-98 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every six months maintenance
Materials required m Seals and spacer m
Spanner wrench m Lint-free gauze pads m
Cotton swabs m Deionized water
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
a To locate the syringes
1
Open the front door of the module and locate the syringes.
B D E F
A
C
G
A
B
C
Internal Standard syringe (ISE 2)
Diluent syringe (ISE 2)
Sipper syringe (ISE 2)
Figure D-41 Syringes in the ISE module
D Internal Standard syringe (ISE 1)
E Diluent syringe (ISE 1)
F Sipper syringe (ISE 1)
G Sample syringe
Roche Diagnostics
Operator’s Manual · Version 2.0
D-99
30 Maintenance (cobas ISE module)
Every six months maintenance cobas ® 8000 modular analyzer series a To remove the syringe
1 Ensure the instrument or the module is in Standby (by masking the module).
(Or: Power off the instrument or the module.)
A
Figure D-42 Remove the syringe
A Knurled holding screw B Syringe holder
2
Loosen the tube connectors and disconnect the tubing at the top and bottom of the syringe.
Use a dry gauze pad to absorb any liquid leaking from the tubing or syringe.
3
Loosen the knurled holding screw ( A ).
4
Lift the syringe up about 1 cm from the syringe holder ( B ) and pull it toward you.
5
Place the syringe on a dry gauze pad.
B
Roche Diagnostics
D-100 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series a To replace the syringe seals
A
30 Maintenance (cobas ISE module)
Every six months maintenance
Reagent syringe
A
A Spanner wrench
Figure D-43 Loosen the retaining screw
1
Use the spanner wrench ( A ) to loosen the retaining screw. Be careful not to bend
B the plunger!
C D E F G
Sample syringe
A B C D E F G
A Plunger
B Retaining screw
Figure D-44
C Spring
D Lower seal
E Spacer
Components of the syringes
F Upper seal
G Syringe barrel
2 Carefully remove the plunger (
A ) together with retaining screw ( B ) from the
syringe barrel.
3
Remove the upper seal ( F ), spacer ( E ), and lower seal ( D ) from the plunger ( A
).
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Operator’s Manual · Version 2.0
D-101
30 Maintenance (cobas ISE module)
Every six months maintenance
NOTICE
NOTICE cobas ® 8000 modular analyzer series
Damage to the syringe tubes by alcohol, grease or detergent
Alcohol, grease or detergent that adheres to the syringe tubes may cause a crack in the syringe.
o Avoid applying alcohol, grease or detergent to the syringes.
o Only use deionized water to clean the syringes.
4 Wipe the plunger with a gauze pad to remove any residue.
5 Mount the retaining screw, spring, new lower seal, spacer, and new upper seal
onto the plunger (see Figure D-44 on page D-101).
o Observe correct orientation of syringe seals and spacer!
o The seals are different in shape depending on the kind of syringe. Check the part numbers before mounting.
6 Inspect the syringe barrel for scratches or cracks at the top and bottom. Replace the syringe barrel if it is scratched or damaged in any way.
7
Insert the plunger ( A ) into the syringe barrel ( G ).
8
With the syringe oriented vertically, check that the spring ( C ) is centered on the lower seal ( D
). If the spring is not centered, it could be damaged during tightening.
Damage to the syringe seals
Do not overtighten the retaining screw. If the retaining screw is overtightened, the syringe seals wear out quickly and the plunger may bend or break, requiring replacement.
9 Tighten the retaining screw with the spanner wrench until the screw is snug, but not overly tight. Check that the plunger can be moved up and down in the syringe by hand, but not too easily.
NOTICE
Roche Diagnostics
D-102 a To reattach the syringe
1 Place the syringe with the knurled holding screw onto the syringe holder by tilting the top of the syringe toward the back.
2 Ensure that the syringe is properly seated in the holder.
Damage to the syringe assembly
If the syringe and the knurled holding screw are not properly seated in the syringe holder, damage to the syringe assembly may occur.
3 The notched (bottom) end of the plunger must be secured within the U-shaped notch of the stepper motor.
4 Rotate the syringe holder until the side tube port is positioned to accept the syringe tubing.
5 Finger-tighten the knurled holding screw.
6 Reconnect the tubing to the top and the side of the syringe and finger-tighten the retaining nuts.
7 Replace all syringes following the procedures above.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
Every six months maintenance
8 Finally, it is important to remove all air bubbles from the syringes and to check
the connections: Perform either maintenance item (6) Air Purge or (8) Reagent
Prime depending on the syringe type.
o If are working on the ISE sample syringe, follow the procedure
To perform an air purge (sample syringe) on page D-103.
o
If are working on an IS, DIL, or sipper syringe, follow the procedure
To prime lines (ISE IS, DIL, and SIP syringes) on page D-104.
During the reagent prime or air purge, make sure the following conditions are met: o
The plungers move vertically.
o There is no leakage from any of the connections.
o
There are no air bubbles in the syringes.
a To perform an air purge (sample syringe)
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Ensure all covers monitored by the interlock function are closed.
2 Power on the instrument or module again.
3 Choose
Utility > Maintenance > (6) Air Purge
.
4 Choose Select to open the Air Purge window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-45 Air Purge window
5 Select the desired module(s).
D-103
30 Maintenance (cobas ISE module)
Every six months maintenance cobas ® 8000 modular analyzer series
6 From the Syringe list box, choose the syringe to be purged of air and choose
Execute .
The respective pipetters will operate. At the rinse stations, water as well as any air are discharged from the probe.
After the air purge, check connections following the procedure
To check syringe connections (all syringes) on page D-105.
a To prime lines (ISE IS, DIL, and SIP syringes)
1 Make sure the top cover is locked because of the interlock function.
2 Power on the instrument or module again.
3 Choose
Utility > Maintenance > (8) Reagent Prime .
4 Choose Select to open the Reagent Prime window.
5 Select one ISE module or both.
6 Choose All in the Prime Item area.
7 Enter 20 in the Cycles text box and choose Execute .
The prime is complete when the instrument returns to Standby.
After the reagent prime, check connections following the procedure
To check syringe connections (all syringes) on page D-105.
Roche Diagnostics
D-104 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
CAUTION
30 Maintenance (cobas ISE module)
Every six months maintenance a To check syringe connections (all syringes)
Incorrect results due to loose tube connectors
A loose tube connector may cause insufficient pipetting and result in inaccurate measurement. o Tighten the tube connector securely and make sure there is no liquid leakage.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: F-6.
1 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 ( A ), try to retighten.
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, disconnect the syringe again. Then wipe the plunger with gauze moistened with deionized water.
o If leakage is found at the bottom of the syringe ( C ), try to attach again.
A
B
A
Roche Diagnostics
Operator’s Manual · Version 2.0
C
A Check connectors for leakage
Figure D-46
B Check for air bubbles inside
C Check bottom of syringe for leakage
Check syringe for leakage and air bubbles
2
Close the front door of the module.
3
If the module was masked, unmask it.
D-105
30 Maintenance (cobas ISE module)
As needed maintenance
As needed maintenance
cobas ® 8000 modular analyzer series
This section describes the maintenance actions for the ISE module that must be performed as needed and are not subject to a regular schedule.
e This section discusses the following maintenance actions:
Cleaning the ISE dilution vessel on page D-106
Replacing the ISE sample probe – elimination of clogging on page D-108
Cleaning instrument surfaces on page D-114
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: o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
a 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. Alarms are issued as this cover is monitored by the interlock function.
3
Remove the covers of the ISE measuring compartments.
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D-106 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A B
30 Maintenance (cobas ISE module)
As needed maintenance
C
C Nozzle receptacle A Vacuum nozzle
B Sipper nozzle
Figure D-47 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 ( C ). Be careful not to damage the nozzles.
A
Roche Diagnostics
Operator’s Manual · Version 2.0
A Dilution vessel
Figure D-48 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.
D-107
30 Maintenance (cobas ISE module)
As needed maintenance cobas ® 8000 modular analyzer series
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 ( C ) and insert a new one.
11 Close the ISE measurement covers.
12 Close the top cover.
13 Delete any alarms concerning the opened cover.
After cleaning the ISE dilution vessel, it is important to perform a reagent prime and an ISE calibration.
If you continue with the next maintenance task
Cleaning the ISE reagent aspiration filters
, the reagent prime can also be performed afterwards.
e See:
To prime and calibrate the ISE module on page D-87.
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:
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: o
Infection and injury due to contact with instrument mechanism on page D-3
Roche Diagnostics
D-108 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
As needed maintenance
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 a To wash a sample probe
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 Num text box (5 cycles are recommended).
5 Choose Execute .
The inside of the sample probe is washed with SmpCln 1 (basic wash).
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
), the sample probe must be detached and clogging must be eliminated.
If the sample probe is still clogged, continue with the next procedures.
a 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
Roche Diagnostics
Operator’s Manual · Version 2.0
A Arm cover
Figure D-49
B Probe seal
C Connector of liquid level sensor
Removing the arm cover of a pipetter
D-109
30 Maintenance (cobas ISE module)
As needed maintenance cobas ® 8000 modular analyzer series
3 Remove the arm cover 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
Loosen the tubing from the probe by unscrewing it. Take care not to drop and lose the probe seal inside the instrument. Locate the probe seal either on the end of the probe tubing or in the retaining nut.
5
Disconnect the connector of the liquid level sensor.
6
Lift the probe from the probe arm.
a To eliminate clogging
Figure D-50 Unclogging the probe
1 To eliminate clogging, use probe cleaning wire (stainless steel) with 0.2 mm diameter.
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.
Roche Diagnostics
D-110 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
As needed maintenance a 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
Roche Diagnostics
Operator’s Manual · Version 2.0
A Probe seal
Figure D-51 Location of the probe seal, correct position of the tubing
3 When reconnecting the tubing, make sure a new probe seal is in place.
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, page D-112
o
To perform an air purge and check the operation of the probe, page D-112
o
To perform a Mechanism Check, page D-113
D-111
30 Maintenance (cobas ISE module)
As needed maintenance
NOTICE cobas ® 8000 modular analyzer series a To check the horizontal alignment of a probe
1 Choose Utility > Maintenance > (2) Check.
2 Select
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 small window on the top 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.
o Do not bend a probe sharply. This can crimp the probe, which must then be replaced.
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.
a 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.
Roche Diagnostics
D-112
Figure D-52 Air Purge window
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 30 Maintenance (cobas ISE module)
As needed maintenance
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.
a To perform a Mechanism Check
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Choose Utility > Maintenance > Check (2).
2 Select
3 Choose Select to open the Mechanism Check window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-53 Mechanism Check window
4 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.
D-113
30 Maintenance (cobas ISE module)
As needed maintenance cobas ® 8000 modular analyzer series
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
NOTICE Damage to instrument surfaces
Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
a 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.
e
See: Instrument statuses for maintenance on page D-14
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.
Roche Diagnostics
D-114 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Table of contents
Maintenance (cobas c 701 and c 502 modules)
This chapter describes the maintenance actions required for correct and efficient running of the c 701 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 · Version 2.0
In this chapter Chapter
31
Maintenance schedule for cobas c 701 and c 502 modules ................................... D-117
Replacing reaction cells and cleaning incubator bath ..................................... D-137
Replacing the pipetter probes – elimination of clogging ................................ D-178
Replacing the pipetter probes (cobas c 701 module) ................................. D-178
D-115
31 Maintenance (cobas c 701 and c 502 modules)
Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
D-116 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Maintenance schedule for cobas c 701 and c 502 modules
Maintenance schedule for cobas c 701 and c 502 modules
The following table lists all maintenance actions required for the photometric modules:
Page
Daily
Weekly
Procedure
c 701 c 502 l l l l l l l l l l l l
Instrument status
–
(a)
SB/MM/
MC/PO
SB/MM/PO
SB/MM
SB/MM/PO
Monthly
Quarterly
Every six months
As needed
Replacing reaction cells and cleaning incubator bath
Cleaning the detergent aspiration filters
Cleaning the ultrasonic mixers
Cleaning the filter of the air ionizer
Cleaning the filter of the solenoid valve
(b)
(c)
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 l l
–
– l l l l l l l
SB/MM/
MC/PO
IBC/PO
SB/MM/PO
SB/MM/PO
IBC/PO/
SB/MM
PO
PO
CPL/PO
PO
SB/MM/PO
SB/MM/PO
SB/MM/PO
PO
SB/MM/PO
Table D-28 Maintenance schedule – c 701 and c 502 modules
(a) From any operational status, such as Standby or Rack Reception mode, or within a maintenance pipe.
(b) Replace the lamp if the photometer check value exceeds 14 000 or when used for more than 750 hours of power-on time.
(c) Replace the syringe seals after six months or after measuring 225 000 tests.
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 e
For more information, see: Instrument statuses for maintenance on page D-14.
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Operator’s Manual · Version 2.0
D-117
31 Maintenance (cobas c 701 and c 502 modules)
Maintenance schedule for cobas c 701 and c 502 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 based on a power-on time of 5 hours per day, 25 days per month . If the maintenance intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
o If your system power-on time is longer, you must create a customized maintenance schedule that matches your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types on page D-28.
Figures of c 701 and c 502 modules
All figures in this chapter are used for illustrative purpose. As the maintenance tasks are performed similarly on both photometric modules, sometimes only the c 701 module is shown as an example for both modules (unless otherwise noticed). c 701
Figure D-54 Figures of c 701 and c 502 modules c 502
Roche Diagnostics
D-118 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance
Daily maintenance
This section describes all maintenance actions for the c 701 and c 502 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.
e This section discusses the following maintenance actions:
Processing green wash rack on page D-119
Cleaning the pipetter probes on page D-122
Cleaning cell rinse nozzles on page D-126
Processing green wash rack
Each day at the end of analysis, process a green rack containing detergents and
Activator as described below. This is a combined maintenance procedure for the
ISE module and 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.
Roche recommends performing the cleaning of the flow paths and conditioning of the electrodes within a Power Off pipe or another maintenance pipe. Then you do not have to perform this maintenance task manually. If the Wash Rack check box is selected for a maintenance pipe and you load a green rack, this pipe is automatically started after the green rack is processed.
e See
Power Off Pipe function on page D-25
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) m SmpCln 1 (basic wash) m SysClean (ISE cleaning solution, only required for ISE module) m Activator (ISE conditioning solution, only required for ISE module) m NaOH-D ( D1 ) reagent packs (only required for c 701 modules)
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
Roche Diagnostics
Operator’s Manual · Version 2.0
D-119
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance cobas ® 8000 modular analyzer series a To clean sample flow paths
1 Place sample tubes into positions 1 to 3 on a green rack (wash rack).
1
2
3
Roche Diagnostics
D-120
Figure D-55
Green rack with reagents
2
Pipet suitable amounts of auxiliary reagents into the sample tubes (see Table D-
Rack pos.
Auxiliary reagent Cycles ISE
(2 units) c 701
1 SmpCln 1
2 SysClean
5
15
–
600 μ L a) c 502
700
μ
L 350
μ
L
– –
600
μ
L a) 3 Activator 15 – –
Table D-29 Required reagents per single module a) For an ISE module with one ISE measuring unit, only 300
(20
μ
L per cycle).
μ
L of SysClean and Activator is required
Ensure correct cup positions
Unless sample cups are positioned as instructed, neither sampling nor washing will be performed.
Number of wash cycles
We recommend the following number of detergent sipping cycles: 15 ISE cycles and
5 photometric cycles. These values should be set by your system administrator on
Utility > System > Wash Racks .
3 Place the green rack on the rack loader.
4 For c 701 modules only: Check the remaining amount of NaOH-D ( D1 ) reagent packs on the Reagent Overview menu. For washing the reagent probes 7600
μ
L of this detergent are required.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance
5 Choose Start (global button) and Start on the Start window.
If the instrument is already in operational status, skip this step.
6 Calibrate the ISE units either prior to powering off the instrument or prior to beginning the next run. Perform a full calibration.
e
See To request an ISE calibration on page B-108.
If washing is interrupted for some reason, perform
followed by
(4) Cell Blank Measurement. For ISE modules, additionally perform (8) Reagent Prime
(ALL).
Roche Diagnostics
Operator’s Manual · Version 2.0
D-121
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance cobas ® 8000 modular analyzer series
Cleaning the pipetter probes
NOTICE
Each day at the end of analysis, clean the outside of the pipetter probes (sample probe, reagent probes, and c 502 Hitergent probe) to remove residual solution and precipitation.
When sample aspiration error occurs frequently or if an alarm for clogging of the sample probe occurs and is not reset after cleaning (maintenance item
Probe Wash ), the sample probe must be detached and clogging must be eliminated.
Probes must be replaced if they are bent or damaged. Positional adjustment is required after reattaching the probe.
e See
Replacing the pipetter probes – elimination of clogging on page D-178
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
Deionized water m Lint-free gauze pads m
Paper towel
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o
Interrupt of operation due to interlock system on page D-13
Damage to the probes
Do not bend or damage the lower end of the probes during cleaning. Move the arm gently.
Do not move it up or down.
a To clean the outside of the c 701 sample probes
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.) e
See: Instrument statuses for maintenance on page D-14
2
Open the rear cover of the module.
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D-122 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance
Sample probes ( c 701) c 701
A Plexiglass cover
Figure D-56 Removing the plexiglass cover above the sample probes
3 Remove the plexiglass cover. Alarms are issued as the plexiglass cover is monitored by the interlock function.
NOTICE
Roche Diagnostics
Operator’s Manual · Version 2.0
c 701
Figure D-57 Cleaning the outside of the c 701 sample probes
4 Move the pipetter probe by hand to an accessible position.
5 While holding the pipetter arm with one hand, wipe – from top to bottom – the outside of all probes with a gauze pad moistened with alcohol.
Damage to instrument surfaces
Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
D-123
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance cobas ® 8000 modular analyzer series
Use a new lint-free gauze pad for each probe to prevent cross contamination.
6 Reattach and close all covers.
7 Delete any alarms concerning the opened cover.
8 Unmask the module if necessary.
Alignment and replacement of pipetter 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.
e See:
Replacing the pipetter probes – elimination of clogging on page D-178
To check the horizontal alignment of a probe on page D-183
a To clean the outside of the c 701 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 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
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. The system requires either a complete power off or at least a reset ( Utility > Maintenance ) to resume normal operation.
4 For c 701 modules: Open the top cover.
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.
Roche Diagnostics
D-124 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance
B
Reagent probes ( c 701)
Sample and reagent probes
( c 502)
NOTICE c 502 c 502
C
A Sample probe ( c 502 sample probe is used to show cleaning of all probes)
B Reagent probe
C Shield pipe (exists only on c 502 modules)
Figure D-58 Cleaning the outside of the probes and the shield pipe
6
Move the pipetter probes by hand to an accessible position.
7
While holding the pipetter arm with one hand, wipe – from top to bottom – the outside of all probes with a gauze pad moistened with alcohol.
Damage to instrument surfaces
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.
8 For c 502 modules only: Also wipe the inside of the shield pipe ( C ) with a gauze pad moistened with alcohol.
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Operator’s Manual · Version 2.0
D-125
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance cobas ® 8000 modular analyzer series
9 Reattach and close all covers.
10 Delete any alarms concerning the opened cover.
11 To terminate Manual Cleaning mode, choose Stop (global button). Afterwards
perform maintenance item (1) Reset for the selected modules.
12 Unmask the module if necessary.
Alignment and replacement of c 701 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.
e See:
Replacing the pipetter probes – elimination of clogging on page D-178
To check the horizontal alignment of a probe on page D-183
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 (
Replacing nozzle tips on cell rinse nozzles on page D-173).
Operator time approximately 5 minutes per c 701 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
D-126 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance a 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.)
2 Open the top cover of the module. For the c 502 module, alarms are issued as this cover is monitored by the interlock function.
A A
A c 701
A Cell rinse units of the c 701 module
B
C c 502
B Retaining screw
C Cell rinse unit of the c 502 module
Figure D-59 Cell rinse units
Roche Diagnostics
Operator’s Manual · Version 2.0
c 701 c 502
Figure D-60 Cleaning the cell rinse nozzles
D-127
31 Maintenance (cobas c 701 and c 502 modules)
Daily maintenance cobas ® 8000 modular analyzer series
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 Delete any alarms concerning the opened cover.
6 If the module was masked, unmask it.
Roche Diagnostics
D-128 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance
Weekly maintenance
This section describes all maintenance actions for the c 701 and c 502 modules that must be performed at least once a week.
e This section discusses the following maintenance actions:
Washing the reaction parts on page D-129
Cleaning the cell covers on page D-131
Cleaning the rinse stations on page D-134
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.
e For instructions on how to remove reaction cells, see
Replacing reaction cells and cleaning incubator bath on page D-137.
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 (maintenance item (7) Wash Reaction Parts)
2. To perform a cell blank measurement (maintenance item (4) Cell Blank
3. To view the cell blank measurement results
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o For c
502 only: Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
D-129
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance c 701 c 502 a To wash the reaction system
1 Ensure the instrument or the module is in Standby (by masking the module).
2 On the Overview menu, select the graphical button of the desired module to open the Reagent Overview window.
3 Check that the remaining amounts of detergent are sufficient. If inadequate, add a new detergent container or reagent pack.
Detergent Description
SmpCln 1
Reagent probe and reaction cell detergent D1
Basic wash
NaOH-D reagent packs on both disks
Consumption approx. 1 mL c 701: approx. 63 mL for each reagent disk c 502: approx. 58 mL
Table D-30 Detergent consumption
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.
a 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.
a To view the cell blank measurement results
1
Choose Print (global button) > Utility > Cell Blank Measurement .
2
Select the module.
3
Choose Preview . The icon on the Print button starts flashing.
4
When the icon has stopped flashing, choose History .
The recent Cell Blank Measurement report is displayed.
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D-130 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance
5 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).
6
If only a few cells are listed in the Abnormal Cell List area, you can continue without any further action.
If more than about 10 reaction cells are affected, remove all reaction cells from the reaction disk and replace the listed cells by new ones.
e
For detailed instructions, see To put the module into Incubator Bath Cleaning mode on page D-138.
Cleaning the cell covers
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 above the ultrasonic mixers at least once a week, including the
U-shaped covers.
Operator time approximately 9 minutes per c 701 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o For c
502 only: Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
D-131
31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance cobas ® 8000 modular analyzer series a 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. For the c 502 module, alarms are issued as this cover is monitored by the interlock function.
c 701
Figure D-61 Removing the cell covers ( c 701 module) c 701
Roche Diagnostics
D-132 c 502
Figure D-62 Removing the cell covers ( c 502 module)
3
Remove the cell covers above the ultrasonic mixers (see Figure D-61 and D-62).
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance
A c 701 c 502 c 701
A Cell cover
Figure D-63 Cleaning the cell covers
B U-shaped covers ( c 701 only)
4 Wipe the front and rear of the cell covers using a gauze pad moistened with alcohol.
Wipe the openings of the cell covers using a cotton swab moistened with alcohol.
Be careful not to splash alcohol into the reaction cells.
5 Pinch the sides of the U-shaped covers ( A ) and pull them off the cell covers.
6 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.
If you are also performing monthly maintenance, we recommend continuing with the following action: e
See: Replacing reaction cells and cleaning incubator bath on page D-137.
7 Attach the dried U-shaped covers and put the cell covers back in place.
8 Close the top cover.
9 Delete any alarms concerning the opened cover.
10 Unmask the module, or continue performing other maintenance tasks.
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Operator’s Manual · Version 2.0
D-133
31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance cobas ® 8000 modular analyzer series
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 % Hitergent solution m Deionized water
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o For c
502 only: Interrupt of operation due to interlock system on page D-13
a To clean the rinse stations (c 701 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
3 Open the top cover and rear covers of the module.
4 Move the pipetter probes to positions that leave the rinse stations easily accessible.
Roche Diagnostics
D-134 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance c 701
Figure D-64
NOTICE
Cleaning the rinse stations of sample probe and reagent probe
5 Using cotton swabs moistened with 2 % Hitergent solution, clean the inside of the rinse stations.
6 Inject about 10 mL of 2 % Hitergent solution into each rinse station.
Damage to instrument surfaces
Do NOT splash Hitergent solution into the drying cylinder.
Immediately clean the surface from any Hitergent spills.
7 Inject about 100 mL of deionized water into each rinse station.
8 Return the sample probes to their original positions.
9 Close all covers of the module.
10 To terminate Manual Cleaning mode, choose Stop (global button). Afterwards
perform maintenance item (1) Reset for the module concerned.
Roche Diagnostics
Operator’s Manual · Version 2.0
a To clean the rinse stations (c 502 module)
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. Alarms are issued as this cover is monitored by the interlock function.
D-135
31 Maintenance (cobas c 701 and c 502 modules)
Weekly maintenance cobas ® 8000 modular analyzer series
3 Move the pipetter probes to positions that leave the rinse stations easily accessible.
c 502
Figure D-65
NOTICE
Cleaning the rinse stations of sample probe, Hitergent probe, and reagent probe
Drying cylinder at sample probe only
4
Using cotton swabs moistened with 2 % Hitergent solution, clean the inside of the rinse stations.
5
Inject about 10 mL of 2 % Hitergent solution into each rinse station.
Damage to instrument surfaces
Do NOT splash Hitergent solution into the drying cylinder.
Immediately clean the surface from any Hitergent spills.
6 Inject about 100 mL of deionized water into each rinse station.
7 Only in the sample probe rinse station: Wipe the drying cylinder with a cotton swab moistened with ethanol or alcohol.
8 Close the top cover.
9 Delete any alarms concerning the opened cover.
10 If the module was masked, unmask it.
Roche Diagnostics
D-136 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
Monthly maintenance
This section describes all maintenance actions for the c 701 and c 502 modules that must be performed at least once a month.
e This section discusses the following maintenance actions:
Replacing reaction cells and cleaning incubator bath on page D-137
Cleaning the detergent aspiration filters on page D-146
Cleaning the radiator filters on page D-149
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:
1. To put the module into Incubator Bath Cleaning mode
2. To remove reaction cells and to clean the incubator bath (c 701 module)
3. To remove reaction cells and to clean the incubator bath (c 502 module)
4. To reinstall reaction parts and to terminate Incubator Bath Cleaning mode
5. To replace reaction cells (without cleaning the incubator bath)
Operator time approximately 16 minutes per c 701 module approximately 15 minutes per c 502 module
System time approximately 2:00 minutes for draining the incubator bath approximately 7:30 minutes for refilling the incubator bath
Materials required m Reaction cells m
Hitergent reagent pack on the outer ring of disk B (at least 10 mL) m Deionized water m
Cotton swabs m Lint-free gauze pads m
Deionized water or 2 % Hitergent (prepared from Hitergent)
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Malfunction due to spilled liquid on page D-4
o For c
502 only: Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
D-137
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series a To put the module into Incubator Bath Cleaning mode
1 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), see
Cleaning the incubator bath with the instrument powered off on page D-145
.
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.
2 Choose Overview > Reagent Overview .
3 Check the remaining volume of Hitergent (consumption approx. 10 mL). If necessary, place a new reagent pack onto the outer ring of reagent disk B.
4 Ensure the instrument or the module is in Standby (by masking the module).
5 Choose Utility > Maintenance > Incubator Bath Cleaning mode .
6 Select the desired module and choose Execute .
The water is drained from the incubator bath.
7 Choose OK to confirm the confirmation window.
8 Choose Maintenance Monitor .
9 Wait until Incubator Bath Cleaning (Wait) is displayed.
Wait until draining is completed
Do not open the top cover while Incubator Bath Cleaning (Draining) is displayed in the
Maintenance Monitor window.
On c 502 modules, an alarm will be issued and maintenance will be stopped.
Roche Diagnostics
D-138 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance a To remove reaction cells and to clean the incubator bath (c 701 module)
1 Ensure the module is in Incubator Bath Cleaning mode.
2 Open the top cover of the module.
A B c 701
A Cell cover
B Bayonet cap (only on the left-most cell cover)
Figure D-66 Removing the cell covers
3
Remove all cell covers. The left-most cell cover (Figure D-66, large) is equipped
with two bayonet caps ( B ). Push down and rotate the caps to lock or unlock the bayonet lock.
Roche Diagnostics
Operator’s Manual · Version 2.0
c 701
Figure D-67 Removing reaction cells
4
Remove all cell rinse units.
5
Remove the reaction cells from the reaction disk. Be careful not to touch the optical surfaces of reaction cells that are to be used again.
D-139
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series
6 Discard the used reaction cells.
o If only reaction cells need to be replaced (without cleaning the incubator bath), continue with
To replace reaction cells (without cleaning the incubator bath) on page D-146.
c 701
A Indented parts near ultrasonic mixers
B Cleaning the incubator bath with a gauze pad
Figure D-68 Cleaning the incubator bath
A
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 ( A ) with a cotton swab.
e For details, see
To clean the surface of the ultrasonic mixer on page D-151.
B
Roche Diagnostics
D-140 c 701
Figure D-69 Cleaning the photometer windows
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
NOTICE
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
Damage to the photometer windows o Do not scratch the photometer windows when cleaning. o Use only gauze pads immersed in deionized water.
9
Carefully wipe the photometer windows ( A ) using a clean lint-free gauze pad (or a cotton swab) moistened with deionized water.
c 701
Figure D-70 Removing the two drain filters
10 Remove the drain filters of the incubator bath. The c 701 module is 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 next procedure:
To reinstall reaction parts and to terminate
Incubator Bath Cleaning mode on page D-144.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-141
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series a To remove reaction cells and to clean the incubator bath (c 502 module)
1 Choose Maintenance Monitor to ensure the module is in Incubator Bath
Cleaning mode.
2 Open the top cover of the module.
A B B
A c 502
A Cell rinse unit
B Cell covers
Figure D-71
3 Remove all cell covers.
Removing the cell covers
4 Remove the cell rinse unit.
B C
Roche Diagnostics
D-142 c 502
A Retaining nut
B Reaction disk
Figure D-72
C
Dismounting the reaction disk
Indented parts near ultrasonic mixers
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
5
Loosen the retaining nut (Figure D-72,
A ) and remove the complete reaction disk
( B ).
6 If the reaction cells are to be used again, be careful not to touch the optical surfaces.
Otherwise remove the reaction cells from the reaction disk.
7 Discard used reaction cells.
8 Using a clean lint-free gauze pad, wipe the inner surfaces of the incubator bath.
9
Wipe the indented parts near the ultrasonic mixers (Figure D-72,
C ) with a cotton swab.
e For details, see
To clean the surface of the ultrasonic mixer on page D-151.
NOTICE c 502
Figure D-73 Cleaning the photometer windows
Damage to the photometer windows o Do not scratch the photometer windows when cleaning. o Use only gauze pads immersed in deionized water.
10
Carefully wipe the photometer windows ( A ) using a clean lint-free gauze pad (or a cotton swab) moistened with deionized water.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-143
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series
Roche Diagnostics
D-144 c 502
Figure D-74 Removing the drain filter ( c 502 module)
11 Remove the drain filter of the incubator bath. Grasp the filter by its handle and pull it out.
12 Clean and rinse the filter with deionized water and return it to its place.
13 Check that the drain filters are correctly installed.
a To reinstall reaction parts and to terminate Incubator Bath Cleaning mode
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 For c 701 modules: Press the F1 push button behind the front doors to terminate the Incubator Bath Cleaning mode.
For c 502 modules: Choose Stop (global button) to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water and Hitergent is added to the water. 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.
e For detailed instructions, see:
To wash the reaction system on page D-130
To perform a cell blank measurement on page D-130
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
A c 701
B c 502
A Tap behind front doors of the c 701 module
B Tap at the rear of the c 502 module
Figure D-75 Tap for manually draining the incubator bath
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.
o Turn the tap to the DRAIN position and drain the incubator bath. The tap is located behind the front doors of the c 701 mod ule and at the rear of the c 502 module.
o Do not let all the water drain. Leave a small amount of water to just cover the bottom of the incubator bath. After draining, turn the tap back to its OPERATION position.
o After cleaning, gradually pour about 500 mL of deionized water into the incubator bath.
Perform maintenance item
(5) Incubation Water Exchange and (4) Cell Blank
Measurement before you resume routine operation.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-145
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series a To replace reaction cells (without cleaning the incubator bath)
If only reactions cells needed to be replaced, perform the following:
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 Choose Stop to terminate Change Reaction Cell mode.
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.
e For detailed instructions, see:
To wash the reaction system on page D-130
To perform a cell blank measurement on page D-130
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
2. To perform a cell detergent prime
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: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
Roche Diagnostics
D-146 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance a 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.
c 701
A CellCln 1
B CellCln 2
Figure D-76
A B
Removing the detergent aspiration filters ( c 701 used as example)
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.
Roche Diagnostics
Operator’s Manual · Version 2.0
c 701 c 502
A Correct
Figure D-77 Inserting the detergent aspiration tube
A
D-147
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
CAUTION cobas ® 8000 modular analyzer series
5 Finally, screw the filter on the tube end and place it back into the container ( A ).
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.
o Insert the aspiration tube into the container all the way until its end touches the bottom of the container.
o 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 .
a 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.
4 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 .
Roche Diagnostics
D-148 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance
Cleaning the radiator filters
Clean the radiator 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 a 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 of the refrigerator
You may get burned by touching the radiator. Avoid touching the radiator when removing the filter.
A c 701
A Radiator filter
Figure D-78 Removing the radiator filter ( c 701 module)
Roche Diagnostics
Operator’s Manual · Version 2.0
D-149
31 Maintenance (cobas c 701 and c 502 modules)
Monthly maintenance cobas ® 8000 modular analyzer series
A
B c 502
C
C Filter of the circuit board rack A Power supply filter
B Radiator filter
Figure D-79 Cleaning power supply filter, the radiator filter and the filter of the circuit board rack ( 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 To reinstall the radiator filter, 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.
Roche Diagnostics
D-150 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance
Quarterly maintenance
This section describes all maintenance actions for the c 701 and c 502 modules that must be performed at least once every three months.
e This section discusses the following maintenance actions:
Cleaning the ultrasonic mixers on page D-151
Cleaning the filter of the air ionizer on page D-153
Cleaning the filter of the solenoid valve on page D-156
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.
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
2. To check the intensity of the ultrasonic output
Operator time approximately 5 minutes per module
System time approximately 2:00 minutes for draining the incubator bath approximately 7:30 minutes for refilling the incubator bath
approximately 3:00 minutes for (9) Cuvette Mixing check
Materials required m 2 % Hitergent solution m Deionized water m Cotton swabs
Before performing this maintenance action, observe the following safety precautions: o
Electrical shock from electronic equipment on page A-8
o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o For c
502 only: Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
a To clean the surface of the ultrasonic mixer
1 Ensure the instrument or the module is in Standby (by masking the module).
2 Choose Utility > Maintenance > Incubator Bath Cleaning mode .
3 Select the desired module and choose Execute .
The water is drained from the incubator bath.
D-151
31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance cobas ® 8000 modular analyzer series
4 Choose OK to confirm the confirmation window.
5 Choose Monitor (at the bottom of the Maintenance menu).
6 Wait until Incubator Bath Cleaning (Wait) is displayed.
Wait until draining is completed
Do not open the top cover while Incubator Bath Cleaning (Draining) is displayed in the
Maintenance Monitor window. For c 502 an alarm will be issued and maintenance will be stopped.
7 Open the top cover of the module.
8 Remove the cell covers above the ultrasonic mixers.
9 Remove the reaction cells near the ultrasonic mixers (at least three cell segments).
Be careful not to touch the optical surfaces of reaction cells.
Roche Diagnostics
D-152 c 701
A
A Ultrasonic mixer
Figure D-80 Cleaning the surfaces of the ultrasonic mixers ( c 701 used as example)
10
Gently wipe the surface of the ultrasonic mixers with cotton swabs moistened with 2 % Hitergent solution.
Then wipe off the detergent with cotton swabs moistened with deionized water.
11
Return the removed sections of reaction cells.
12
Return the cell covers.
13
Close the top cover of the module.
14
For c 701 modules: Press the F1 push button behind the front doors to terminate the Incubator Bath Cleaning mode.
For c 502 modules: Choose Stop (global button) to terminate the Incubator Bath
Cleaning mode.
The incubator bath is filled with water and Hitergent is added to the water. The instrument returns to Standby.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance a To check the intensity of the ultrasonic output
1 Choose Utility > Maintenance .
2 Select Check (2) from the left list.
3 Select
.
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.
Cleaning the filter of the air ionizer
The air ionizer (or ion blower) reduces static charges on components in the reaction area to ensure accuracy of measurement. Clogging of the air ionizer filter may reduce the efficiency of electrical discharge. Check the filter once every three months and clean the filter if it is dirty.
Operator time approximately 7 minutes per c 701 module
Before performing this maintenance action, observe the following safety precautions: o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
a To clean the air ionizer filter (c 701 only)
1 Power off the complete instrument or the desired module.
2 Open the top cover of the module.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-153
31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance cobas ® 8000 modular analyzer series
A
B
C c 701
A Air ionizer
B Guide rails
Figure D-81
C Retaining screws
Dismounting the air ionizer
3 From the front of the module: Loosen the two retaining screws ( C ). Do not
4 remove them.
Push the air ionizer to the rear of the module along the guide rails (
5 Open the left rear cover of the module.
B ).
A
B
C
Roche Diagnostics
D-154
A Filter cover
B Filter
Figure D-82
C Fan speed switch (on the bottom side)
Removing the air ionizer filter
6 Remove the filter cover ( A ) and the filter ( B ) from the air ionizer.
7 Wash the filter with tap water, dry it well, and then reinstall it.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance
Check the position of the fan speed switch
Ensure that the switch ( C ) on the bottom side of the air ionizer is in position 2.
8 Return the air ionizer back in its place and fasten the retaining screws.
9 Close the top and rear covers of the module.
10 Power on the instrument or module again, or continue performing other maintenance tasks.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-155
31 Maintenance (cobas c 701 and c 502 modules)
Quarterly maintenance cobas ® 8000 modular analyzer series
Cleaning the filter of the 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. Clean the filter and the inner walls once every three months.
Operator time approximately 3 minutes per c 701 module
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
a To clean the solenoid valve unit filter (c 701 only)
1
Power off the complete instrument or the desired module.
2
Open the front doors of the module.
A c 701
A Solenoid valve filter (sponge)
Figure D-83 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.
Roche Diagnostics
D-156 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
Every six months maintenance
This section describes the maintenance actions for the c 701 and c 502 modules that must be performed at least once every six months.
e This section discusses the following maintenance actions:
Replacing the photometer lamp on page D-157
Replacing the syringe seals on page D-163
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 .
e 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
2. To remove the photometer lamp (c 701 modules)
3. To remove the photometer lamp (c 502 modules)
4. To install a new photometer lamp (c 701 and c 502 modules)
Operator time approximately 4 minutes per c 701 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 a 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 .
Roche Diagnostics
Operator’s Manual · Version 2.0
D-157
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance cobas ® 8000 modular analyzer series
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.
WARNING
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
o For c
502 only: Interrupt of operation due to interlock system on page D-13
a To remove the photometer lamp (c 701 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.
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.
o Wait about 30 minutes after turning off lamp power.
o Check that the photometer lamp unit has cooled down before replacing the lamp.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: T-4.
6
Open the top cover of the module.
Roche Diagnostics
D-158 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
7 Open the right front door.
A
Roche Diagnostics
Operator’s Manual · Version 2.0
c 701
D C B
A Photometer lamp cover
B Connector
Figure D-84
C Cable clip
D Retaining screws
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 ( B ) of the lamp wires.
11
Loosen both retaining screws ( D ) and take out the photometer lamp. When the screws become easy to turn, the lamp can be detached.
Continue with the next procedure:
To install a new photometer lamp (c 701 and c 502 modules) on page D-162
.
a To remove the photometer lamp (c 502 modules)
1
Choose
Utility > Maintenance. > (13) Change Photometer Lamp
.
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.
D-159
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
WARNING cobas ® 8000 modular analyzer series
Burns due to hot surface of the photometer lamp unit!
You may be burned if you touch any part of the photometer lamp unit.
o Wait about 30 minutes after turning off lamp power.
o Check that the photometer lamp unit has cooled down before replacing the lamp.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: T-4.
6
Open the top cover of the module.
7
Loosen the retaining screw of the cell rinse unit and lift off the entire unit.
8
Remove the cell cover above the ultrasonic mixers.
A
B c 502
A Retaining nut
Figure D-85
B Reaction disk
Dismounting the reaction disk ( c 502 only)
9
Loosen the retaining nut ( A ) and remove the reaction disk ( B ) inclusive reaction cells from system. Be careful not to touch the optical surfaces.
If the reaction disk is detached with the reaction cells left in place, water drops adhering to the outside of the reaction cells may drip onto the detector, causing an alarm to be issued.
Roche Diagnostics
D-160 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
B c 502
E D C
A Photometer housing
B Retaining screws
Figure D-86
C Cover of the connector
D Connector
E Cable clip
Removing the photometer lamp
10
Rotate the connector cover ( C ) and disconnect the connector ( D ) of the lamp wire.
11
Loosen both retaining screws ( B ) and take out the photometer lamp. When the screws become easy to turn, the lamp can be detached.
Continue with the next procedure:
To install a new photometer lamp (c 701 and c 502 modules) on page D-162
.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-161
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance cobas ® 8000 modular analyzer series a To install a new photometer lamp (c 701 and c 502 modules)
1 Insert the new photometer lamp.
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 c 701 c 502
A Pin hole
Figure D-87
B Guide pin
Installing a new photometer lamp
2
Align the pin hole in the lamp base with the guide pin of the lamp housing and tighten the two lamp retaining screws.
3
Connect the wire connector. Secure the lamp wires with the cable clip.
4
Reinstall all parts and close the covers of the module.
5
Choose Stop (global button) to terminate Change Photometer Lamp mode.
6
Wait about 30 minutes for the photometer lamp to stabilize.
7
Perform a cell blank measurement before you resume routine operation. This is necessary to compensate for a possible change in light intensity.
e For instructions, see
To perform a cell blank measurement on page D-130.
Roche Diagnostics
D-162 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
Replacing the syringe seals
Replace the syringe seals every six months or after 225 000 tests, whichever occurs first. Worn-out syringe seals can cause leakage and inaccurate pipetting.
o The procedure for replacing the syringe seals is the same for all syringes. Note, however that there are different spare parts for sample and reagent syringes.
o The figures in this section refer to a reagent syringe as an example.
o Perform the entire seal replacement for the first syringe before starting with the next.
Do not dismount more than one syringe at a time because the internal parts of the syringes differ and may be easily mistaken with each other.
This maintenance comprises the following procedures and maintenance items:
3. To replace the syringe seals
5. To perform an air purge (sample and reagent syringes)
6. To check syringe connections (all syringes)
Operator time approximately 6 minutes per syringe
System time
approximately 2:35 minutes for (6) Air Purge
Materials required m Seals and spacer m Spanner wrench m Lint-free gauze pads m Cotton swabs m Deionized water
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
Roche Diagnostics
Operator’s Manual · Version 2.0
D-163
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance cobas ® 8000 modular analyzer series a To locate the syringes
1 Open the front door of the module and locate the syringes.
c 701 module
B C D E
A
F c 502 module c 701
A R1-A syringe (left rear pipetter)
B R2/3-A syringe (left front pipetter)
C R1-B syringe (right rear pipetter)
Figure D-88 Syringes in the c
D
E
F
701 module
R2/3-B syringe (right front pipetter)
Sample A syringe (left pipetter)
Sample B syringe (right pipetter)
(position of the pipetters from the front view )
B C D
A
Roche Diagnostics
D-164 c 502
A Sample syringe (left pipetter)
B R1 syringe (front pipetter)
Figure D-89 Syringes in the c 502 module
C R2 syringe (rear pipetter)
D Hitergent syringe
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance a To remove the syringe
1 Power off the complete instrument or the desired module.
B
A c 701 c 502
Figure D-90 Remove the syringe
A Knurled holding screw B Syringe
C Syringe holder
2
Loosen the tube connectors (Figure D-90, left image) and disconnect the tubing at
the top and bottom of the syringe.
Use a dry gauze pad to absorb any liquid leaking from the tubing or syringe.
3
Loosen the knurled holding screw ( A ).
4
Lift the syringe ( B ) up about 1 cm from the syringe holder ( C ) and pull it toward you.
5
Place the syringe on a dry gauze pad.
C
Roche Diagnostics
Operator’s Manual · Version 2.0
D-165
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance a To replace the syringe seals
A cobas ® 8000 modular analyzer series
Sample syringe
A c 701 c 502
A Spanner wrench
Figure D-91 Loosen the retaining screw
1
Use the spanner wrench ( A ) to loosen the retaining screw (Figure D-92, B
).
B
Be careful not to bend the plunger!
C D E F G
Reagent/Hitergent syringe
A B C D E F G
A Plunger
B Retaining screw
Figure D-92
C Spring
D Lower seal
E Spacer
Components of the syringes
F Upper seal
G Syringe barrel
2 Carefully remove the plunger (
A ) together with retaining screw ( B ) from the
syringe barrel.
3
Remove the upper seal ( F ), spacer ( E ), and lower seal ( D ) from the plunger ( A
).
Roche Diagnostics
D-166 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
NOTICE
NOTICE
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
Damage to the syringe tubes by alcohol, grease or detergent
Alcohol, grease or detergent that adheres to the syringe tubes may cause a crack in the syringe.
o Avoid applying alcohol, grease or detergent to the syringes.
o Only use deionized water to clean the syringes.
4 Wipe the plunger, syringe barrel and spacer with a gauze pad or cotton swab moistened with deionized water.
5 Mount the retaining screw, spring, new lower seal, spacer, and new upper seal
onto the plunger (see Figure D-92 on page D-166).
o Observe correct orientation of syringe seals and spacer!
o The seals are different in shape depending on the kind of syringe. Check the part numbers before mounting.
6 Inspect the syringe barrel for scratches or cracks at the top and bottom. Replace the syringe barrel if it is scratched or damaged in any way.
7
Insert the plunger ( A ) into the syringe barrel ( G ).
8
With the syringe oriented vertically, check that the spring ( C ) is centered on the lower seal ( D
). If the spring is not centered, it could be damaged during tightening.
Damage to the syringe seals
Do not overtighten the retaining screw. If the retaining screw is overtightened, the syringe seals wear out quickly and the plunger may bend or break, requiring replacement.
9 Tighten the retaining screw with the spanner wrench until the screw is snug, but not overly tight.
10 Check that the plunger can be moved up and down in the syringe by hand, but not too easily.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-167
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance
NOTICE cobas ® 8000 modular analyzer series a To reattach the syringe
1 Place the syringe with the knurled holding screw onto the syringe holder by tilting the top of the syringe toward the back.
2 Ensure that the syringe is properly seated in the holder.
Damage to the syringe assembly
If the syringe and the knurled holding screw are not properly seated in the syringe holder, damage to the syringe assembly may occur.
3 The notched (bottom) end of the plunger must be secured within the U-shaped notch of the stepper motor.
4 Rotate the syringe holder until the side tube port is positioned to accept the syringe tubing.
5 Finger-tighten the knurled holding screw.
6 Reconnect the tubing to the top and the side of the syringe and finger-tighten the retaining nuts.
7 Replace all syringes following the procedures above.
8 Finally, it is important to remove all air bubbles from the syringes and to check the connections: Follow the procedure
To perform an air purge (sample and reagent syringes) on page D-169.
During the air purge, make sure the following conditions are met: o The plungers move vertically.
o There is no leakage from any of the connections.
o There are no air bubbles in the syringes.
Roche Diagnostics
D-168 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance a To perform an air purge (sample and reagent syringes)
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Ensure all covers monitored by the interlock function are closed.
2 Power on the instrument or module again.
3 Choose
Utility > Maintenance > (6) Air Purge
.
4 Choose Select to open the Air Purge window.
CAUTION
Air Purge window Figure D-93
5 Select the desired module(s).
6 From the Syringe list box, choose the syringe to be purged of air and choose
Execute .
The respective pipetters will operate. At the rinse stations, water as well as any air are discharged from the probe.
Incorrect results due to loose tube connectors
A loose tube connector may cause insufficient pipetting and result in inaccurate measurement. o Tighten the tube connector securely and make sure there is no liquid leakage.
o
Observe the system safety labels illustrated from page A-18 to A-26 and in
particular the following: F-6.
After the air purge, check connections following the procedure
To check syringe connections (all syringes) on page D-170.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-169
31 Maintenance (cobas c 701 and c 502 modules)
Every six months maintenance cobas ® 8000 modular analyzer series a To check syringe connections (all syringes)
1 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 ( A ), try to retighten.
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, disconnect the syringe again. Then wipe the plunger with gauze moistened with deionized water.
o If leakage is found at the bottom of the syringe ( C ), try to attach again.
B
A
A
C c 701 c 502
A Check connectors for leakage
Figure D-94
B Check for air bubbles inside
C Check bottom of syringe for leakage
Check syringe for leakage and air bubbles
2
Close the front doors of the module.
Roche Diagnostics
D-170 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance
As needed maintenance
This section describes the maintenance actions for the c 701 and c 502 modules that must be performed as needed and are not subject to a regular schedule.
e This section discusses the following maintenance actions:
Unclogging cell rinse nozzles on page D-171
Replacing nozzle tips on cell rinse nozzles on page D-173
Draining the vacuum tank on page D-175
Replacing the pipetter probes – elimination of clogging on page D-178
Cleaning instrument surfaces on page D-187
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
Roche Diagnostics
Operator’s Manual · Version 2.0
D-171
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series a 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. For the c 502 module, alarms are issued as this cover is monitored by the interlock function.
A A
A c 701
A Cell rinse units of the c 701 module
B
C c 502
B Retaining screw
C Cell rinse unit of the c 502 module
Figure D-95 Cell rinse units
3
Loosen the retaining screw of one cell rinse unit and lift off the entire unit.
Roche Diagnostics
D-172 c 701 c 502
Figure D-96 Unclogging the cell rinse nozzles with cleaning wire 0.5 mm
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance
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
Repeat steps 3 to 5 for each of the remaining cell rinse units.
7 Close the top cover.
8 Delete any alarms concerning the opened cover.
9 If the module was masked, unmask it.
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.
Nozzle tips can only be replaced on c 701 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
Materials required m Needle-nose pliers or radio pliers m Nozzle tips
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a To replace the cell rinse nozzle tips (for c 701 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 the cell rinse unit and lift off the entire unit.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-173
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series
A c 701
A Nozzle tip
Figure D-97 Replacing the cell rinse nozzle tips
B
A
4 Grip the nozzle tip ( A ) with pliers and pull it off. Be careful not to bend the nozzle.
Correct alignment
A
C
Roche Diagnostics
D-174
Incorrect alignment
A Nozzle tip
B Guide bars
Figure D-98
C Reaction cell
Alignment of a nozzle tip in relation to reaction cells
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
Repeat steps 3 to 7 for each of the remaining cell rinse units.
9
Close the top cover.
10
If the module was masked, unmask it.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance a To check the alignment of the nozzle tips (for c 701 only)
1 Choose Utility > Maintenance > (2) Check.
2 Select
(4) Probe Check and open the corresponding window.
3
Cell rinse units ( c 701)
2
1
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 Stop (global button).
6
Perform maintenance check (3) Mechanism Check (30 cycles) to check the
movement of the mechanical components. e
See To perform a Mechanism Check on page D-186.
Draining the vacuum tank
an instrument alarm will be issued.
If a mechanical problem is detected, the mechanism check will be interrupted and
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: o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
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Operator’s Manual · Version 2.0
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31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series a 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.
A B B c 701 c 701
A Vacuum tank (behind cover)
B Drain tubes of vacuum tank
Figure D-99 Draining the vacuum tank ( c 701 module)
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D-176 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance
A c 502
A Drain tube of vacuum tank
Figure D-100 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.
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.
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31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series
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:
2. To replace a probe
Probes can only be replaced on c 701 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. a To wash a sample probe
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 Choose Execute .
The inside of the sample probe is washed with SmpCln 1 (basic wash).
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
), the sample probe must be detached and clogging must be eliminated.
If the sample probe is still clogged, continue with the next procedures.
Replacing the pipetter probes (cobas c 701 module)
This maintenance comprises the following procedures and maintenance items:
1. To remove the plexiglass cover above the c 701 sample probes
2. To detach a c 701 sample or reagent probe
4. To reattach a c 701 sample or reagent probe
5. To check the tubing system for leakage (for c 701 only)
6. To check the horizontal alignment of a probe
7. To perform an air purge and check the operation of the probe
8. To perform a Mechanism Check
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)
Roche Diagnostics
D-178 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o For c
701 only: Interrupt of operation due to interlock system on page D-13
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 a To remove the plexiglass cover above the c 701 sample probes
1
Power off the complete instrument or the desired module.
2
Open the rear cover of the module.
A c 701
A Plexiglass cover
Figure D-101 Removing the plexiglass cover above the sample probes
3
Remove the plexiglass cover.
4
Continue with step 3 of the next procedure.
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Operator’s Manual · Version 2.0
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31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series a To detach a c 701 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
A Arm cover
Figure D-102
B Probe seal
C 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.
4 Loosen the tubing from the probe by unscrewing it. Take care not to drop and lose the probe seal ( B ) inside the instrument. Locate the probe seal either on the end of the probe tubing or in the retaining nut.
5 Disconnect the connector of the liquid level sensor ( C ).
6 Lift the probe from the probe arm.
Roche Diagnostics
D-180 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series a To eliminate clogging
Sample probe
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance
Reagent probe
Figure D-103 Unclogging probes
1
To eliminate clogging, use probe cleaning wire (stainless steel) with the following diameters: o
For sample probes: 0.2 mm diameter.
o For reagent probes: 0.5 mm diameter.
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.
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Operator’s Manual · Version 2.0
D-181
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series a To reattach a c 701 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
Roche Diagnostics
D-182
A Probe seal
Figure D-104 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. A new probe always comes with a new seal.
4 Reattach the arm cover; the rear section first and then the front section.
5 Reattach the plexiglass cover above the c 701 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 horizontal alignment of a probe, page D-183
o
To perform an air purge and check the operation of the probe, page D-185
o
To perform a Mechanism Check, page D-186
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
CAUTION
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance a To check the tubing system for leakage (for c 701 only)
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Start up the instrument.
2 When initial operation is completed, open the top and the rear cover of the c 701 module. Keep the plexiglass cover mounted.
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.
5 If there is a leak, power off the instrument or module temporarily, wipe up the leaked water, and reattach the retaining nut.
6 Then, start up the instrument and check again.
7 Reattach the arm covers.
8 Go through the following procedures before you resume routine operation: o
To check the horizontal alignment of a probe, page D-183
o
To perform an air purge and check the operation of the probe, page D-185
o
To perform a Mechanism Check, page D-186
a To check the horizontal alignment of a probe
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
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
During and at the completion of Probe Check mode, be careful not to come in contact with a moving probe.
5
Choose Execute to start the Probe Check mode.
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Operator’s Manual · Version 2.0
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31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series
A
NOTICE c 701
A F1 push button moves the probe horizontally
Figure D-105
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.
o Do not bend a probe sharply. This can crimp the probe, which must then be replaced.
o 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 the Probe Check mode, choose Stop (global button).
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D-184 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance a To perform an air purge and check the operation of the probe
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Choose
Utility > Maintenance> (6) Air Purge
.
2 Choose Select to open the Air Purge window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-106 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 corresponding pipetter will operate. 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 water is not dispensed in a straight flow, unclog the probe.
e
See: Replacing the pipetter probes – elimination of clogging on page D-178
Now continue with the mechanism check.
D-185
31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series a To perform a Mechanism Check
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
1 Choose Utility > Maintenance > Check (2).
2 Select
3 Choose Select to open the Mechanism Check window.
Figure D-107 Mechanism check window
4 Select the desired module.
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.
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D-186 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 31 Maintenance (cobas c 701 and c 502 modules)
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Interrupt of operation due to interlock system on page D-13
NOTICE Damage to instrument surfaces
Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
a 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.
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Operator’s Manual · Version 2.0
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31 Maintenance (cobas c 701 and c 502 modules)
As needed maintenance cobas ® 8000 modular analyzer series
Roche Diagnostics
D-188 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Table of contents
Maintenance (cobas e 602 module)
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 · Version 2.0
In this chapter Chapter
32
Cleaning ProCell/CleanCell nozzles and replace reservoirs ........................... D-195
Cleaning ProCell/CleanCell stand and aspiration tubes ................................. D-213
Cleaning ProCell/CleanCell aspiration tube filters .......................................... D-217
Cleaning the reagent disk and compartment .................................................... D-221
Extended power OFF and ON procedures ........................................................ D-229
D-189
32 Maintenance (cobas e 602 module)
Table of contents cobas ® 8000 modular analyzer series
Roche Diagnostics
D-190 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (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 Instrument status
Daily
Weekly
Every two weeks
Quarterly
As needed
Cleaning ProCell/CleanCell nozzles and replace reservoirs
Cleaning the mixing and separation stations
Replacing the pinch valve tubings
Cleaning ProCell/CleanCell stand and aspiration tubes
Cleaning ProCell/CleanCell aspiration tube filters
Cleaning the reagent disk and compartment
MC/PO
SB/MM
MC/PO
SB/MM/PO
MC/PO
MC/PO
SB
PO
SB/MM/PO
SB/MM/PO
SB/MM
Cleaning the solid waste compartment
SB/MM/PO
SB/MM
SB
SB/MM/PO
Table D-31
Extended power OFF and ON procedures
Maintenance schedule
Instrument status (mode) PO
Power Off (or module powered off on Utility > System Configuration > Module
Settings )
SB Standby mode
MM
Module Masked ( Start > Masking > Module Masking ), puts single modules in a status equal to Standby
MC Manual Cleaning mode
Page e
For more information, see: Instrument statuses for maintenance on page D-14.
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 based on a power-on time of 5 hours per day, 25 days per month . If the maintenance intervals are violated, this may lead to deterioration of system performance or damages to the instrument.
o If your system power-on time is longer, you must create a customized maintenance schedule that matches your laboratory’s individual requirements.
e For more information on scheduling maintenance tasks, see:
Maintenance types on page D-28.
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Operator’s Manual · Version 2.0
D-191
32 Maintenance (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
Alcohol (e.g., isopropyl alcohol or ethanol) m Deionized water m
Paper towel
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
NOTICE a 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
Wait until the probes on the selected modules moved to their cleaning positions.
3 Touch a screw on the rack loader 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
Do not place a gauze pad moistened with alcohol on the instrument surface as the finish may be damaged.
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D-192 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
NOTICE
32 Maintenance (cobas e 602 module)
Daily maintenance
Damage to the probes o Do not bend or damage the lower end of the probes during cleaning. Move the arm gently. Do not move it up or down.
o Use a new lint-free gauze pad for each probe to prevent cross contamination.
Figure D-108 Cleaning the outside of the sample probe
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.
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Operator’s Manual · Version 2.0
D-193
32 Maintenance (cobas e 602 module)
Daily maintenance cobas ® 8000 modular analyzer series
Roche Diagnostics
D-194
C
A Reagent probe
B Sipper probes for measuring channels
C Pre-wash probes
Figure D-109 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.
10
To terminate Manual Cleaning mode, choose Stop (global button). Afterwards
perform maintenance item (1) Reset for the module concerned.
B
A
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance
Weekly maintenance
This section describes all maintenance actions for the e 602 module that must be performed at least once a week.
e This section discusses the following maintenance actions:
Cleaning ProCell/CleanCell nozzles and replace reservoirs on page D-195
Cleaning the mixing and separation stations on page D-200
Cleaning the incubator on page D-202
Cleaning the microbead mixer on page D-204
Cleaning the rinse stations on page D-206
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a 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.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-195
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series a 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 on the rack loader in order to discharge any static charge which may have built up on you.
3 Open the top cover.
A B
NOTICE
A Sipper probe
B Black handle
C Unit with PC/CC filling nozzles and electrodes
Figure D-110 Pull up the ProCell/CleanCell filling nozzles and electrodes
C
Damage to the sipper probes o 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.
o Do not bend the electrodes for LLD inside the reservoir. If they are bent, contact technical support.
4 Manually move the sipper probes ( A ) over the incubator.
5 Use the black handle ( B ) to gently pull up the PC/CC filling unit ( C ) to the
stop/hold position as shown in Figure D-110.
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D-196 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance
A B
A Reservoir filling nozzle B Electrodes
Figure D-111 Cleaning the filling nozzles and electrodes
6
Clean the ProCell/CleanCell reservoir filling nozzle (
) and electrodes (
wiping them with a cotton swab moistened in deionized water.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-197
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series a Procedure 3 - To replace ProCell/CleanCell reservoirs
A ProCell/CleanCell reservoirs
Figure D-112 Cleaning ProCell/CleanCell reservoirs
A
1 Carefully remove the ProCell/CleanCell reservoirs (
) (upward /left direction)
2 making sure the electrodes are not bent.
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.
5 Choose Stop (global button) once cleaning is complete.
6 Choose Yes to stop maintenance after confirmation. Afterwards perform
for the module concerned.
Roche Diagnostics
D-198 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance a Procedure 4 - To perform a reagent prime
1 Choose Utility >
Maintenance > (8) Reagent Prime .
Figure D-113 Reagent Prime window o Select the desired e 602 module and deselect all other modules.
o
Select the Reagent option in the e 602 Prime Item area ( reagent refers to
ProCell and CleanCell). o Enter 1 in the Cycles text box.
o
Choose Execute to start reagent priming.
2
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.
e
See Finalization on page D-227.
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Operator’s Manual · Version 2.0
D-199
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Damage to the e 602 module due to the use of acid or alkaline solutions for cleaning on page D-5
NOTICE a 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
Wait until the probes on the selected modules moved to their cleaning positions.
3
Touch a screw on the rack loader 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
Do not bend or damage the lower end of the sipper and dispenser probes during cleaning.
Roche Diagnostics
D-200 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance
C A B
Example of the cleaning procedure for all mixing and separation stations:
A Separation stations
B Vortex mixing station (Pre-wash area)
Figure D-114 Cleaning the mixing stations and the separation stations
C Vortex mixing station (consumables area)
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.
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 Stop (global button). Afterwards
perform maintenance item (1) Reset for the module concerned.
Mechanical parts on the selected module move to their standby positions.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-201
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Damage to the e 602 module due to the use of acid or alkaline solutions for cleaning on page D-5
a 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 on the rack loader 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
D-202
A Incubator cover
Figure D-115 Cleaning the incubator cover
5
Remove the cover of the incubator.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance
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.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-116 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.
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.
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.
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.
D-203
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
NOTICE a 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
Wait until the probes on the selected modules moved to their cleaning positions.
3 Touch a screw on the rack loader in order to discharge any static charge which may have built up on you.
4 Open the top cover.
Damage to the microbead mixer o Do not bend the microbead mixer during cleaning.
o Look and make sure the microbead mixer is not bent.
Roche Diagnostics
D-204 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A
32 Maintenance (cobas e 602 module)
Weekly maintenance
Roche Diagnostics
Operator’s Manual · Version 2.0
A Microbead mixer paddle
B Propeller blades
Figure D-117 Cleaning the microbead mixer
B
5
Very carefully wipe the microbead mixer paddle ( A ) with a lint-free gauze pad moistened with alcohol from top to bottom.
6
Use a brush to clean the 4 propeller blades ( B ) with alcohol.
7
Repeat the procedure using deionized water instead of alcohol.
8
Close the top cover and lock it with the key.
9
To terminate Manual Cleaning mode, choose Stop (global button). Afterwards
perform maintenance item (1) Reset for the module concerned.
The probes on the selected module move to their standby positions.
D-205
32 Maintenance (cobas e 602 module)
Weekly maintenance cobas ® 8000 modular analyzer series
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% Hitergent m
50-mL syringe with tubing attached
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
a 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 >
Manual Cleaning
; see To put a module in Manual Cleaning mode on page D-17).
Wait until the probes on the selected modules moved to their cleaning positions.
3
Touch any screw on the rack loader in order to discharge any static charge which may have built up on you.
4
Open the top cover.
Roche Diagnostics
D-206 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Weekly maintenance
C D A B
Example of the cleaning procedure for all rinse stations:
C Rinse station for reagent probe
D Rinse station for sipper probes
A Rinse station for microbead mixer
B Rinse station for Pre-wash probes
Figure D-118 Cleaning the rinse stations
5
Clean the inside of each rinse station using a cotton swab moistened with alcohol, followed by a cotton swab moistened with deionized water.
6
Fill a syringe (with tubing attached) with 50 mL of 2% Hitergent solution.
7
Inject the Hitergent solution (empty the syringe) into the drain hole of the rinse station.
8
Fill a syringe with 50 mL of deionized water.
9
Inject the deionized water (empty the syringe) into the drain hole of the rinse station.
10
Repeat steps 5-9 for all rinse stations.
11
Close the top cover and lock it with the key.
12
To terminate Manual Cleaning mode, choose Stop (global button). Afterwards
perform maintenance item (1) Reset for the module concerned.
The probes on the selected module move to their standby positions.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-207
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Every two weeks maintenance
Every two weeks maintenance
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.
e 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
Roche Diagnostics
D-208 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Every two weeks maintenance a To prepare liquid flow path cleaning
1 Open the top cover.
2 Fill the SysClean adapters with SysClean solution to the lower line (approximately
9 mL/cup).
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-119 Placing the SysClean adapters
3 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.
4 Close the top cover.
a To perform liquid flow path cleaning
1 Choose Utility >
Maintenance > (26) Liquid Flow Cleaning .
2 Choose Select to display the Liquid Flow Path 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 .
6 Open the top cover.
7 Remove both SysClean adapters.
8 Dispose of any remaining SysClean solution. Rinse the SysClean adapters thoroughly with deionized water.
D-209
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Quarterly maintenance
Quarterly maintenance
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.
e 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a 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.
Roche Diagnostics
D-210 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
Quarterly maintenance
A
B
C
WARNING
A Tube fitting
B Tubing
Figure D-120
Infection from samples
Replacing pinch valve tubings
C Pinch valve
Liquid from the tubings and the acrylic block comes from the measuring cell and is potentially biohazardous.
o Wear gloves when removing the tubings. Wipe up all spills immediately.
4 Carefully remove (pull) all 4 pinch valve tubings (
).
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 ( C ).
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 on page D-212
o
To perform MC preparation on page D-212
Roche Diagnostics
Operator’s Manual · Version 2.0
D-211
32 Maintenance (cobas e 602 module)
Quarterly maintenance cobas ® 8000 modular analyzer series a To perform sipper air purge
1 Power on the instrument or the module.
2 After initialization is finished, choose Utility >
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
sipper probe.
a 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.
Roche Diagnostics
D-212 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (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.
e This section discusses the following maintenance actions:
Cleaning ProCell/CleanCell stand and aspiration tubes on page D-213
Cleaning ProCell/CleanCell aspiration tube filters on page D-217
Cleaning the reagent disk and compartment on page D-221
Cleaning the solid waste compartment on page D-224
Extended power OFF and ON procedures on page D-229
Cleaning instrument surfaces on page D-239
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
CleanCell causes severe burns!
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a 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.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-213
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
A
B
C
Figure D-121
C Filter A Notch
B Aspiration tube notches (
).
Pulling up the aspiration tubes
3 Pull the aspiration tubes (
B ) up and to the left to secure them on their respective
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.
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cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
Figure D-122 Removing the bottles and cleaning the aspiration tubes
4 Cap the ProCell and CleanCell bottles and remove them from the module.
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 · Version 2.0
A ProCell and CleanCell stand
Figure D-123 Cleaning the stand for ProCell and CleanCell bottles
6 Remove the ProCell and CleanCell stand ( A ) from the module.
A
D-215
32 Maintenance (cobas e 602 module)
As needed maintenance
CAUTION cobas ® 8000 modular analyzer series
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.
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.
o Ensure the bottle stand is present before placing the ProCell and CleanCell bottles.
o To prevent evaporation, check that each bottle is closed correctly by the slider cap.
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 to ensure there are no air bubbles in the fluid system.
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.
e
See: To perform a reagent prime on page D-220
To perform finalization on page D-228.
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D-216 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
Cleaning ProCell/CleanCell aspiration tube filters
Clean the ProCell and CleanCell aspiration tube filters if they are blocked (an instrument alarm is issued in this case).
This maintenance comprises the following procedures and maintenance items:
1. To clean ProCell/CleanCell aspiration tube filters
Operator time approximately 5 minutes
System time 15 minutes
Materials required m
Lint-free gauze pads m ProCell/CleanCell bottle caps m
Deionized water
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
CleanCell causes severe burns!
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a To clean ProCell/CleanCell aspiration tube 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 middle door of the module.
Roche Diagnostics
Operator’s Manual · Version 2.0
D-217
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
Figure D-124 Pulling up the aspiration tubes and removing the bottles
3
Pull the aspiration tubes up and to the left to secure them on their respective notches.
4
Cap the ProCell and CleanCell reagent bottles and remove them from the module.
Droplets of ProCell and CleanCell may trickle when ProCell and CleanCell bottles are removed. If this occurs, use paper towels to wipe up the liquid.
Roche Diagnostics
D-218
Figure D-125 Cleaning the outside of the aspiration filters
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
5 Wipe the outside of the aspiration filters with lint-free gauze pads moistened with deionized water, then dry them with dry gauze pads.
6 Unscrew the filters from the aspiration tubes.
CAUTION
Figure D-126
7 Clean the filters with deionized water, dry them with a lint-free gauze pad and replace them.
Cleaning the inside of the aspiration filters
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.
o Ensure the bottle stand is present before placing the ProCell and CleanCell bottles.
o To prevent evaporation, check that each bottle is closed correctly by the slider cap.
8
Return the ProCell and CleanCell reagent bottles to their original positions and remove the caps.
9
Lower the aspiration tubes into the bottles. Ensure that the bottles are closed by the slider caps.
10
Close the middle door of the module.
11
Unmask the module if it was masked.
After returning the ProCell and CleanCell bottles, it is important to perform a reagent prime to ensure there are no air bubbles in the fluid system. Continue the procedure to perform a reagent prime and a finalization.
e See:
To perform a reagent prime on page D-220
To perform finalization on page D-228
Roche Diagnostics
Operator’s Manual · Version 2.0
D-219
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series a To perform a reagent prime
1 Choose Utility > Maintenance
.
Figure D-127 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.
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, a finalization must be performed.
If further samples are to be processed, finalization is not necessary.
e
See Finalization on page D-227.
Roche Diagnostics
D-220 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
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 reinstall the reagent disk
NOTICE
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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Fire and burns due to the use of alcohol on page D-3
a To clean the reagent disk
1
Ensure the instrument or the module is in Standby (by masking the module).
Damage to the microbead mixer o Do not bend the microbead mixer when cleaning the reagent disk compartment.
o Look and make sure the microbead mixer is not bent.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-128 Removing the cover from the reagent disk
2 Unlock and open the cover from the reagent disk.
D-221
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
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 package insert for the onboard stability of reagents).
Figure D-129 Removing the reagent disk
5 Loosen and remove the black thumbscrews.
6 Remove the empty reagent disk from the compartment.
7 Wipe the inside and outside of the reagent disk with lint-free gauze pads moistened with deionized water.
If the disk appears dirty, use lint-free gauze pads moistened with alcohol to clean the disk, followed by lint-free gauze pads moistened with deionized water.
8 Dry the reagent disk with a cloth or lint-free towels. Set the reagent disk aside.
Roche Diagnostics
D-222 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance a To clean the reagent disk compartment
A
Roche Diagnostics
Operator’s Manual · Version 2.0
A Barcode reader window
Figure D-130
1
Wipe the reagent disk compartment with lint-free gauze pads moistened with deionized water.
Cleaning the reagent disk compartment
Do not scratch or smear the barcode reader window ( A ) as this may cause barcode reading errors.
If the compartment still appears dirty, use lint-free gauze pads moistened with alcohol, followed by lint-free gauze pads moistened with deionized water.
2
Dry the reagent disk compartment with a cloth or lint-free towels.
a To reinstall the reagent disk
1
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.
2
Reinstall and tighten the thumbscrews.
3
Return the cobas e packs to the reagent disk.
4
Replace and lock the reagent disk cover.
The caps of the cobas e packs are opened and the reagents are registered automatically.
5
Close the top cover of the module.
6
Unmask the module if it was masked.
D-223
32 Maintenance (cobas e 602 module)
As needed maintenance 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: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
WARNING a 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.)
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. o 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. o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o If waste solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
o
Observe the system safety labels illustrated on pages A-18 to A-26 and in particular
Roche Diagnostics
D-224 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
A
32 Maintenance (cobas e 602 module)
As needed maintenance
B
A Green status lamp
B Handle of the magazine drawer
Figure D-131 Opening 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 · Version 2.0
A B C C
A WasteLiner
B Solid waste containers
C Empty magazines
Figure D-132
D
Cleaning the magazine drawer
Magazine waste compartment
3
Remove both WasteLiners ( A ) from the solid waste containers ( B ).
4
Remove the empty magazines ( C ) from the magazine waste compartment.
D-225
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
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.
Roche Diagnostics
D-226
1 Green button for left WasteLiner
2 Green button for right WasteLiner
Figure D-133 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.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Finalization
32 Maintenance (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 water, the measuring channels are filled with ProCell, and the sipper probes are cleaned with water.
Finalization is performed automatically after completion of measurement (so called post operation ). It must only be initiated manually if it was not performed automatically (after pressing the Stop button or due to an error) or did not complete
(alarm is issued) and the instrument will stand unused for several hours.
Always start finalization in combination with reagent prime. Never perform finalization alone.
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
a 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 .
3 Choose Select to display the Reagent Prime window.
Roche Diagnostics
Operator’s Manual · Version 2.0
Figure D-134 Reagent Prime window
4 Select the desired e 602 module.
5 Select the Reagent option in the e 602 Prime Item area.
6 Enter 5 in the Cycles text box.
7 Choose Execute to start reagent priming.
D-227
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
Wait until the reagent prime is finished and the instrument enters Standby, before you continue.
a 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.
Roche Diagnostics
D-228 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
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 D-32
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
Use the normal power off procedure if the instrument will not be in use for 1 to
2 days (e.g., a weekend).
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.
e e
See:
Power Up Pipe function on page D-23.
For more information about powering off, see:
Powering off the instrument on page B-67.
a 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.
e
See Instrument inspection on page B-68
Roche Diagnostics
Operator’s Manual · Version 2.0
D-229
32 Maintenance (cobas e 602 module)
As needed maintenance
Power ON 1 cobas ® 8000 modular analyzer series
The following procedure corresponds to
, an extended Power OFF
Procedure applied if the instrument will not be in use for 1 to 2 days (for example, a weekend).
The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering on.
e See
Recommended maintenance pipes on page D-26.
Before performing this maintenance action, observe the following safety precautions: o
Infection and injury due to contact with instrument mechanism on page D-3
a To prepare e 602 modules for routine operation
1
Start up the instrument automatically or manually.
e
See To automatically start up the instrument on page B-49
To manually start up the instrument on page B-49
2
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.
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.
4
After system air purge, open the middle door of the module.
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A
A
B
32 Maintenance (cobas e 602 module)
As needed maintenance
C
A Check connectors for leakage
Figure D-135
(the reagent syringe is used as example) visible at any of their fittings.
B Check for air bubbles inside
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 o If leakage is found at a tube connector ( A ), try to retighten.
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.
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32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
Figure D-136 Reagent Prime window
7 Choose Utility > Maintenance
. o Select the W2 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 .
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.
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D-232 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
Power OFF 2
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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
System time approximately 45 minutes
The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering off.
e See
Recommended maintenance pipes on page D-26.
a To perform liquid flow path cleaning e For a detailed description of this procedure, see:
Cleaning the liquid flow path on page D-208.
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 .
Ensure the instrument has returned to Standby mode before continuing.
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32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series a To remove reagents and consumables
1 Remove the reagent 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.
a To perform reagent prime
1 Choose Utility > Maintenance
.
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D-234
Figure D-137 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.
2
Display the Reagent Prime window a second time.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance
Figure D-138 Reagent Prime window o Select the W2 Sipper option in the e 602 Prime Item area. o
Enter 5 in the Cycles text box.
o Choose Execute to start reagent priming.
a 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.
a 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.
Roche Diagnostics
Operator’s Manual · Version 2.0
a 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
e For more information, see:
Daily maintenance on page D-192
Weekly maintenance on page D-195
2
Press the orange Operation Power OFF button at the front of the core unit.
3
Turn off the external water supply.
D-235
32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
4
Perform the instrument inspection, either now or before the next power-on.
e
See Instrument inspection on page B-68
Power ON 2
The procedures below correspond to
, an extended Power OFF
Procedure applied if the instrument will not be used 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
The maintenance items listed in this procedure can be programmed as a maintenance pipe to be performed automatically when powering on.
e See
Recommended maintenance pipes on page D-26.
Before performing this maintenance action, observe the following safety precautions: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
o
Contamination of the environment due to inappropriate treatment of waste on page A-10
a 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.
e
See To automatically start up the instrument on page B-49
To manually start up the instrument on page B-49
6 Enter your operator ID and password to log on.
When initialization is completed, the analyzer goes into Standby.
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.
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cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 module)
As needed maintenance a 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
Figure D-139
B Check for air bubbles inside
C Check bottom of syringe for leakage
Check syringe for leakage and air bubbles
(the reagent syringe is used as example)
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 ( A ), try to retighten.
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.
5 Close the middle door of the module.
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32 Maintenance (cobas e 602 module)
As needed maintenance cobas ® 8000 modular analyzer series
Roche Diagnostics
D-238
Figure D-140 Reagent Prime window
6 Choose Utility > Maintenance
.
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
. o Select the W2 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.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 32 Maintenance (cobas e 602 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: o
Infection from samples and associated materials on page A-9
o
Skin inflammation or injury caused by reagents and other working solutions on page A-9
o
Infection from waste solution and solid waste on page A-10
o
Infection and injury due to contact with instrument mechanism on page D-3
NOTICE Damage to instrument surfaces
Do not use alcohol or bleach to clean instrument surfaces as the finish may be damaged.
a 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 on the rack loader 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.
This is the last page of Part D.
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32 Maintenance (cobas e 602 module)
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Roche Diagnostics
D-240 Operator’s Manual · Version 2.0
Troubleshooting
E
33 Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
34 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-65
cobas ® 8000 modular analyzer series
Data alarms
33 Data alarms
Table of contents
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.
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33
E-3
33 Data alarms
Table of contents
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Operator’s Manual · Version 2.0
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Roche Diagnostics
Operator’s Manual · Version 2.0
33 Data alarms
Table of contents
E-5
33 Data alarms
Table of contents cobas ® 8000 modular analyzer series
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E-6 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 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. These alarms comprise data alarms (referring to irregular measuring results or conditions) and instrument alarms
(referring to irregular system conditions). Alarms are classified into four levels:
Alarm levels
Data alarm
Warning
Sampling stop
Stop
This alarm is related to the results of calibrations, QC or patient samples. The instrument does not stop operation.
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 measurement.
This alarm is related to problems with the instrument. For the pipetted sample, measurement is continued.
This alarm is related to problems with the instrument. The instrument stops operation. For the sample under measurement, no result data are obtained and the measurement must be repeated.
Alarm indication 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.
Instrument alarms are indicated by the Alarm button (global button) on the
Overview menu as well as by an audible alarm. If an alarm occurs, the Alarm button lights up. Its color indicates the alarm level: o Yellow indicates warning level o Red indicates sampling stop or stop
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.
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.
e
For more information, see Rerun list on page E-63
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarm list
Data alarm list
Flag Alarm
Det.S
>I.H
>I.HI
>I.I
>I.L
>I.LH
>I.LHI
>I.LI
>ISE
QCErr1
QCErr2
Table E-1
AB level range over (Assay Buffer=ProCell)
Calibration result abnormal (Sample flag)
Measuring cell temperature out of range
Unable to calculate compensated test
Data error in compensated test
Measuring cell current range over
Interference by hemolysis
Interference by hemolysis and icterus
Interference by icterus
Interference by lipemia
Interference by lipemia and hemolysis
Interference by lipemia, hemolysis and icterus
Interference by hemolysis
ISE range over
Prozone error 2 / Kinetic unstable
Reaction limit over (substrate depletion)
Data alarm list (Sheet 1 of 2)
The following table displays the data alarms applicable to ISE tests, c 701 tests, c 502 tests, e 602, and their presentation (flag) on submenus and reports.
–
–
c 701 c 502 e 602
– –
–
–
–
–
–
–
–
–
–
–
–
– –
–
–
–
– –
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
ISE
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
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Flag
Samp.O
Table E-1
Alarm
Reagent, diluent, or Pre-Treatment film
Reagent, diluent, or Pre-Treatment hovering
Abnormal reagent disk temperature
Repeat limit over (upper / lower)
ABS maximum over (non-lin curve)
Sample carryover
Data alarm list (Sheet 2 of 2)
Washing buffer short (PreClean)
Washing buffer temperature (PreClean)
33 Data alarms
Data alarm list
ISE
–
–
–
–
–
–
–
–
–
–
–
–
– c 701 c 502 e 602
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
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33 Data alarms
Data alarms (cobas ISE module)
Data alarms (cobas ISE module)
ADC.E
cobas ® 8000 modular analyzer series
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 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.
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.
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas ISE module)
Remedy 1 Correct the condition that occurred during the latest calibration and caused the alarm.
2 Recalibrate.
ClcT.E
CmpT.?
Alarm Calculated test error
Description Calculation error has occurred.
Cause A data alarm has occurred for a test needed in the calculation. This is not valid for the following errors and alarms: o
Calculation not possible (Calc.?)
o
Test-to-test compensation disabled (CmpT.?)
Remedy 1 Correct the data alarm of the test to be used for the calculation.
2 Rerun the sample.
Alarm Unable to calculate compensated 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 test-to-test compensation error (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
Correct the data alarm of the test to be used for compensation.
2
Rerun the sample.
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>I.HI
>I.H
33 Data alarms
Data alarms (cobas ISE module)
CmpT.E
cobas ® 8000 modular analyzer series
Alarm Data error in compensated 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, test-to-test compensation disabled, overflow, random error, systematic error, QC error and outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy
1
Correct 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 replaced rerun result is marked with an Edited alarm on the
Data Review submenu. This also prints on the patient report.
Cause The result data has been edited.
Remedy Check the result of measurement.
Alarm Serum index check: interference by hemolysis.
Description The hemolytic value is greater than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy Check the results of measurement.
Alarm Serum index check: interference by hemolysis and icterus.
Description The hemolytic and icteric values are greater than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy Check the results of measurement.
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas ISE module)
>I.I
Alarm Serum index check: interference by icterus.
Description The icteric value is greater than the specified reference value.
Cause A highly icteric sample was measured.
Remedy Check the results of measurement.
>I.L
Alarm Serum index check: interference by lipemia.
Description The lipemic value is greater than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy Check the results of measurement.
>I.LH
Alarm Serum index check: interference by lipemia and hemolysis.
Description The lipemic and hemolytic values are greater than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy Check the results of measurement.
>I.LHI
Alarm Serum index check: interference by lipemia, hemolysis, and icterus.
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 Check the results of measurement.
>I.LI
Alarm Serum index check: interference by lipemia and icterus.
Description The lipemic and icteric values are greater than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy Check the results of measurement.
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas ISE module)
>ISE
Alarm ISE range over
Description If the data is outside the following ranges, ISE range over is issued.
Na +
K +
Cl -
45.0 - 49.9 mV
45.0 - 49.9 mV
-39.9 - -35 mV
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?
2
Continue with routine analysis. Continue with step 3 at the end of the day.
3
Replace the appropriate electrode according to the procedure in the Maintenance
Guide.
e
See Replacing the Na, K and Cl electrodes on page D-88.
4
Resume operation.
If alarm recurs, call technical support.
ISE.E
Alarm ISE voltage level error
Roche Diagnostics
E-14
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
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
Set the reagent and perform maintenance item (8) Reagent Prime for the ISE
module.
2
Replace the electrode 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.
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas ISE module)
4 Set the internal standard solution properly 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
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
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 power low level
Description The ultrasonic monitor value is lower than the reference value.
Cause The mixer is deteriorated.
Remedy Call technical support.
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33 Data alarms
Data alarms (cobas ISE module)
Over.E
cobas ® 8000 modular analyzer series
Alarm Overflow
Description Display is not possible because the output figure exceeds 6 digits
Cause The data obtained has more than six digits including negative sign and decimal point.
Remedy 1 Minimize the difference in concentration between the sample and calibrator.
2 Obtain the result data with six characters including negative sign and decimal point.
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 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.
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Samp.C
33 Data alarms
Data alarms (cobas ISE module)
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 alarm recurs, call technical support.
Samp.O
Alarm Possible sample carryover.
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 measurement 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 alarm recurs, call technical support.
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Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas ISE module)
< >Test
Alarm ISE sample range over
>Test / <Test
Description If the data is out of the following ranges, Sample range over is issued:
Na +
K +
Cl -
10-250 mmol/L
1-100 mmol/L
10-250 mmol/L
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.
e
See Replacing the Na, K and Cl electrodes on page D-88.
4
Resume operation. If alarm recurs, call technical support.
Alarm Upper/Lower technical Limit
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
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.
In case of urine samples with a >Test alarm, a manual rerun can be performed with decreased volume (6.5
μ
L instead of normal volume).
2
Perform maintenance item (18) Sample Probe Wash.
3
Clean the outside of the sample probe manually.
If alarm recurs, call technical support.
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E-18 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
Data alarms (cobas c 701 and c 502 modules)
>Abs
Alarm ABS over
Description The absorbance value to be used for calculation after cell blank correction exceeded
33 000.
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
O
Clean the incubator bath if it is contaminated.
e
See: Replacing reaction cells and cleaning incubator bath on page D-137.
O
Choose Utility > Maintenance and perform maintenance item
O Check the Photometer Check results on the printout (Abs < 14 000).
O
Replace the photometer lamp, if necessary.
O Resume operation. If alarm recurs, call technical support.
o
If all samples are affected intermittently:
For example, if any reaction cell is scratched, replace the cell.
e
For further instructions, see: Replacing reaction cells and cleaning incubator bath on page D-137
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Operator’s Manual · Version 2.0
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
ADC.E
cobas ® 8000 modular analyzer series
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.
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 o o During calculation the denominator became zero.
An overflow occurred in logarithmic or exponential calculation.
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 alarm recurs, call technical support.
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E-20 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
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.
ClcT.E
Alarm Calculated test error
Description Calculation error has occurred.
Cause A data alarm has occurred for the test needed in the calculation. This is not valid for the following data alarms: o
Calculation not possible (Calc.?)
o
Test-to-test compensation disabled (CmpT.E)
Remedy
1
Correct the data alarm of the test to be used on the calculation.
2
Recalibrate.
CmpT.?
Alarm Unable to calculate compensated 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 test-to-test compensation error (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 Correct the data alarm of the test to be used for compensation.
2 Rerun the sample.
Roche Diagnostics
Operator’s Manual · Version 2.0
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
CmpT.E
cobas ® 8000 modular analyzer series
Alarm Compensation Error between Tests
Description 1. In test-to-test compensation calculation, a data alarm for the compensation test data is indicated.
2. Calculation not possible, test-to-test compensation disabled, overflow, random error, systematic error, QC error and outside of expected value.
Cause The test to be used for compensation has a data alarm.
Remedy
1
Correct the data alarm on the test to be used for compensation.
2
Rerun the sample.
>Cuvet
Alarm Cell blank abnormal
Description The cell blank value used for measurement exceeds the reference value by more than
0.1 Abs.
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
3 Ensure that there is no excessive foaming or particles in the incubator bath.
4 Resume operation. If alarm recurs, ensure there is adequate rinse water and cell blank water from the rinse mechanism. The cells must be completely filled.
5 Choose Utility > Maintenance
and perform maintenance item (5) Incubation
6 Resume operation. If alarm recurs, choose Utility > Maintenance and perform
maintenance item (4) Cell Blank Measurement.
o If cells are out of specification, replace the cells.
o
If the results for the first cell are greater than 14 000 or if the deviation of the cells is
±
1000 or more, replace the cells and repeat the cell blank measurement.
e
See: Replacing reaction cells and cleaning incubator bath on page D-137.
7 Resume operation. If alarm recurs, call technical support.
Roche Diagnostics
E-22 Operator’s Manual · Version 2.0
>I.HI
>I.H
cobas ® 8000 modular analyzer series
Det.S
33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
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.
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 replaced rerun result is marked with an Edited alarm on the
Data Review submenu. This also prints on the patient report.
Cause The result data has been edited.
Remedy Check the result of measurement.
Alarm Serum index check: interference by hemolysis.
Description The hemolytic value is larger than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy Check the results of measurement.
Alarm Serum index check: interference by hemolysis and icterus.
Description The hemolytic and icteric values are larger than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy Check the results of measurement.
Roche Diagnostics
Operator’s Manual · Version 2.0
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
>I.I
cobas ® 8000 modular analyzer series
Alarm Serum index check: interference by icterus.
Description The icteric value is larger than the specified reference value.
Cause A highly icteric sample was measured.
Remedy Check the results of measurement.
>I.L
Alarm Serum index check: interference by lipemia.
Description The lipemic value is larger than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy Check the results of measurement.
>I.LH
Alarm Serum index check: interference by lipemia and hemolysis.
Description The lipemic and hemolytic values are larger than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy Check the results of measurement.
>I.LHI
Alarm Serum index check: interference by lipemia, hemolysis, and icterus.
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 Check the results of measurement.
Roche Diagnostics
E-24 Operator’s Manual · Version 2.0
>Lin
cobas ® 8000 modular analyzer series
>I.LI
33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
Alarm Serum index check: interference by lipemia and icterus.
Description The lipemic and icteric values are larger than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy Check the results of measurement.
>Kin
Alarm Prozone error 2 / Kinetic unstable
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.
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 incubation 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 > 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.
e
See: Replacing reaction cells and cleaning incubator bath on page D-137.
6
Resume operation. If alarm recurs, call technical support.
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Operator’s Manual · Version 2.0
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
MIXLOW
cobas ® 8000 modular analyzer series
Alarm Mixing power low level
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.
e
See Cleaning the ultrasonic mixers on page D-151.
2 Call technical support.
MIXSTP
Over.E
Alarm Ultrasonic mixing error
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 Supply water to the incubator bath.
Alarm Overflow
Description Display is not possible because the output figure 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 data obtained has more than six digits including negative sign and decimal point.
Remedy
1
Reduce the number of decimal places on Utility >Application > Range .
2
Obtain data with six characters including negative sign and decimal point.
Roche Diagnostics
E-26 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
>Proz
33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
Alarm Prozone error 1
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
Alarm Reaction limit over (substrate depletion)
Description In a rate assay, the rate of change in main wavelength absorbance exceeds the specified limit value.
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 box 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.
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
ReagEx
cobas ® 8000 modular analyzer series
Alarm Reagent expired
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.
e For more information, see
Reagent Overview window (cobas ISE module) on page B-104
Reagent Overview window (cobas c 701 module) on page B-115.
2 Exchange expired reagents.
Reag.S
cobas c 701 module only
This section describes the Reag.S flag for c 701 modules.
Alarm Reagent short
Description For photometric tests, there is insufficient reagent volume in the cobas c pack. The liquid level cannot be detected in the cobas c pack.
Cause o
There is not enough reagent in the reagent pack.
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 submenu.
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 alarm recurs, call technical support.
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E-28 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas c 701 and c 502 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.
e
For more information see Samp.C
Samp.O
Alarm Possible sample carryover.
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 measurement with a new sample aliquot.
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33 Data alarms
Data alarms (cobas c 701 and c 502 modules)
Samp.S
cobas ® 8000 modular analyzer series
Alarm Sample short
Description The liquid level cannot be detected in the sample container.
e
For more information see Samp.S
>Test / <Test
Alarm Upper/Lower technical limit
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.
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E-30 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas e 602 module)
Data alarms (cobas e 602 module)
>AB
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.
AB.E
Alarm AB level check error
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
Rerun all flagged samples.
3
If the error recurs, call technical support.
ADC.E
Alarm ADC abnormal
Description The analog-digital converter does not work normally.
Cause o Numerical conversion is abnormal.
o
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.
3
If the alarm recurs, call technical support.
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33 Data alarms
Data alarms (cobas e 602 module)
Calc.?
Alarm Calculation not possible
Description The denominator becomes zero in calculation.
Cause Internal calculation error occurred.
Remedy Rerun the sample.
cobas ® 8000 modular analyzer series
Cal.E (Sample flag)
Alarm Calibration result abnormal (Sample flag)
Description No calibration data or previous calibration data used.
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.
CarOvr
Roche Diagnostics
E-32
Alarm Potential microbead carryover
Description The signal level of this sample is low.
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: o Qualitative assay results are below cutoff o Quantitative assays are below the lower limit of the clinical decision
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Cell.T
33 Data alarms
Data alarms (cobas e 602 module)
Alarm Measuring cell temperature out of range
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
2 Resume measurement.
3 If the alarm recurs, call technical service.
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33 Data alarms
Data alarms (cobas e 602 module)
>Curr
cobas ® 8000 modular analyzer series
Alarm Measuring cell current range over
Description The measuring cell current is out of range when checked during run preparation.
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
Curr.E
During operation:
1 Choose Utility > Maintenance
and perform maintenance item (24) MC
2 Rerun the sample.
3 If alarm recurs immediately, call technical support.
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 alarm recurs immediately, call technical support.
Edited
Roche Diagnostics
E-34
Alarm Edited test
Description An edited first result or replaced rerun result is marked with an Edited alarm on the
Data Review submenu. This also prints on the patient report.
Cause The result data has been edited manually.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas e 602 module)
>I.H
Alarm Serum index check: interference by hemolysis.
Description The hemolytic value is greater than the specified reference value.
Cause A highly hemolytic sample was measured.
Remedy Check the results of measurement.
>I.HI
Alarm Serum index check: interference by hemolysis and icterus.
Description The hemolytic and icteric values are greater than the specified reference values.
Cause A highly hemolytic and icteric sample was measured.
Remedy Check the results of measurement.
>I.I
Alarm Serum index check: interference by icterus.
Description The icteric value is greater than the specified reference value.
Cause A highly icteric sample was measured.
Remedy Check the results of measurement.
>I.L
Alarm Serum index check: interference by lipemia.
Description The lipemic value is greater than the specified reference value.
Cause A highly lipemic sample was measured.
Remedy Check the results of measurement.
>I.LH
Alarm Serum index check: interference by lipemia and hemolysis.
Description The lipemic and hemolytic values are greater than the specified reference values.
Cause A highly lipemic and hemolytic sample was measured.
Remedy Check the results of measurement.
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Operator’s Manual · Version 2.0
E-35
Inc.T
33 Data alarms
Data alarms (cobas e 602 module)
>I.LHI
cobas ® 8000 modular analyzer series
Alarm Serum index check: interference by lipemia, hemolysis, and icterus.
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 Check the results of measurement.
>I.LI
Alarm Serum index check: interference by lipemia and icterus.
Description The lipemic and icteric values are greater than the specified reference values.
Cause A highly lipemic and icteric sample was measured.
Remedy Check the results of measurement.
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 alarm recurs, call technical support.
Over.E
Roche Diagnostics
E-36
Alarm Overflow
Description The result exhibits mathematical overflow.
Cause The display of the calibrator data result contains more than 7 digits (6 digits including a negative sign or decimal point).
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms (cobas e 602 module)
Remedy 1 Minimize the difference in concentration between sample and calibrator.
2 Repeat the calibration.
ReagEx
Alarm Reagent expired
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 on the reagent unload list with the ReagEx alarm.
2
Exchange expired reagents.
Reag.F
Alarm Reagent, diluent, or Pre-Treatment film
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.
Reag.H
Alarm Reagent, diluent, or Pre-Treatment 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 alarm recurs, call technical support.
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33 Data alarms
Data alarms (cobas e 602 module)
Reag.S
cobas ® 8000 modular analyzer series
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.
o If the volume is not adequate, replace the low reagent pack and perform a reagent scan.
o
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 alarm recurs, call technical support.
Reag.T
Alarm Abnormal 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 alarm recurs, call technical support.
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cobas ® 8000 modular analyzer series 33 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 > System
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 > System > 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
3
Rerun the sample.
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33 Data alarms
Data alarms (cobas e 602 module)
Samp.C
cobas ® 8000 modular analyzer series
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.
Samp.H
Alarm Sample hovering
Description The sample probe hovers over the sample.
Cause A premature LLD signal is detected during sample pipetting.
Remedy 1 Check for bubbles in the sample.
2 Choose Utility > Maintenance
and perform maintenance item (1) Reset.
Samp.O
Alarm Possible sample carryover.
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
1
Repeat measurement with a new sample aliquot.
2
If alarm recurs, call technical support.
Roche Diagnostics
E-40 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Samp.S
33 Data alarms
Data alarms (cobas e 602 module)
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.
1
Check the sample volume, add the required sample volume and rerun.
2
Resume operation.
3
If alarm recurs, call technical support.
<SigL
Alarm Low signal level
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 alarm recurs, call technical support.
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33 Data alarms
Data alarms (cobas e 602 module)
SLLD.E
cobas ® 8000 modular analyzer series
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 Auxiliary 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 that the volumes in the ProCell/CleanCell bottles and replace, if necessary.
2 Resume operation.
3 Rerun the sample.
Roche Diagnostics
E-42 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
SysR.T
33 Data alarms
Data alarms (cobas e 602 module)
Alarm Auxiliary 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.
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 alarm recurs, call technical support.
>Test / <Test
Alarm Upper/Lower technical limit
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.
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Operator’s Manual · Version 2.0
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33 Data alarms
Data alarms (cobas e 602 module)
WB.S
cobas ® 8000 modular analyzer series
Alarm Washing buffer short (PreClean)
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 (PreClean)
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.
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 alarm recurs, call technical support.
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E-44 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations
Flag
Table E-2
Alarms for calibrations
Alarm
The following table displays all calibration data alarms applicable to ISE tests, c 701 tests, c 502 tests, e 602 tests, and their presentation (flag) on submenus and reports.
Internal standard concentration abnormal
Data alarm list
ISE
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
– c 701
–
–
c 502
–
–
–
–
–
–
–
–
–
–
e 602
–
–
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Operator’s Manual · Version 2.0
E-45
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations
Cal.E
Alarm CALIB error (Calib flag)
Displayed in Calibration > Status > Calibration Trace .
Description The current calibrator concentration value or slope value differs from the previous one by more than the specified Compensated Limit. The Compensated Limit is a limit for the difference | previous value – current value | expressed as percentage of the average (previous value + current value)/2.
The Cal.E
alarm is a warning only, not necessarily indicative of 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 .
Roche Diagnostics
E-46 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations
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
Cl
-
-68.1 mV or less
-68.0 mV to -40.0 mV
Slope value
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 E-3
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
Na
+
, K
+ Slope.E
+ 40 + 45
Prep.E
+ 50 + 55
(Normal range)
+ 60
Cond.E
+ 65 + 68 mV
Cond.E
(Normal range) Prep.E
Slope.E
Cl
-
- 68 - 65 - 60 - 45
Judgement on ISE electrode replacement
- 40 - 35
Figure E-1 ISE data alarms and corresponding slope values (electrode voltage) o If the alarm “ISE slope error (Slope.E)” appears, replace the electrodes at once.
- 30 o If the alarm “Preparation abnormal (Prep.E)” appears during calibration, you may continue the day’s analyses and replace the electrodes next day.
mV 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.
Remedy
1
Perform green wash rack with activator on the 3rd position.
2
Pour fresh calibrator ISE Low [Std(1)], ISE High [Std(2)], and ISE Comp.
[Std (3)], place on calibration rack and recalibrate the ISE units.
3
Resume operation. If alarm recurs, call technical support.
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Operator’s Manual · Version 2.0
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33 Data alarms
Alarms for calibrations
Diff.E
cobas ® 8000 modular analyzer series
Alarm Minimum acceptable difference
Description The difference of the signals between each level of calibrators is below the permissible value.
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.
Dup.E
This section describes the Dup.E flag for photometric modules and for immunological modules.
cobas c 701 and cobas c 502 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 ?
4 Continue with result calculations. No Dup.E alarm is issued.
5 Is the % error < the % Duplicate Limit?
6 Dup.E alarm is issued for this result.
Roche Diagnostics
E-48
Cause The difference between the first and second measurement (absorbance) of a calibrator is greater than Duplicate Limit Abs and greater than the % Duplicate Error.
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations
Remedy 1 Recalibrate.
2 Check reagent storage, handling and expiration date. Replace the reagent if necessary and recalibrate.
3 If alarm recurs, call technical support.
If this alarm occurs, a Std.E alarm is issued. The Std.E alarm prevents updating of calibration for the affected test.
cobas e 602 module
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.
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
1
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 actual performed calibration and the related stored calibration. The calibration factor is only used as calibration validation criteria and not used for sample calculation.
Cause Red calibration: range < 0.8 or > 1.2
Remedy 1 Recalibrate.
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Operator’s Manual · Version 2.0
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33 Data alarms
Alarms for calibrations
IStd.E
cobas ® 8000 modular analyzer series
Alarm Internal standard concentration abnormal
Displayed on Calibration > Status > Calib Trace.
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 alarm recurs, call technical support.
Mono.E
Alarm Monotony of curve
Description The working curve is not monotonically increasing or monotonically decreasing.
Cause o The ProCell is expired.
o The calibrator did not reach room temperature.
Remedy 1 Replace ProCell.
2 Place the calibrator appropriately.
12 February 2010
Roche Diagnostics
E-50 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Prep.E
33 Data alarms
Alarms for calibrations
Alarm Preparation abnormal
Displayed on Calibration > Status > Calib 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.
Na + , K + Slop.E
Prep.E
(Normal range) Cond.E
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
Cl Cond.E
(Normal range) Prep.E
Slop.E
Figure E-2
- 68 - 65 - 60 - 45 - 40 - 35 - 30
ISE data alarms and corresponding slope values (electrode voltage) mV
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 Check standards, reagents, and controls. If controls are in range, and standards and reagents are acceptable, resume operation. Otherwise, correct abnormalities and recalibrate.
4 Resume operation. If alarm recurs, call technical support.
e For more information on ISE calibration alarms, see:
Rsp1.E
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.
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33 Data alarms
Alarms for calibrations cobas ® 8000 modular analyzer series
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 activator 2 and 3.
5 Prepare fresh calibrator; place on calibration rack and recalibrate the ISEs.
6
Resume operation. If alarm recurs, repeat steps 3 through 5 a maximum of two
times. If alarm recurs, replace the ISE electrodes.
Rsp2.E
S1A.E
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 e See
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 alarm recurs, call technical support.
Roche Diagnostics
E-52 Operator’s Manual · Version 2.0
33 Data alarms
Alarms for calibrations cobas ® 8000 modular analyzer series
SD.E
Sens.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 .
The result of the calibration is not updated.
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 >
Others .
5
Resume operation. If alarm recurs, call technical support.
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 .
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 alarm recurs, call technical support.
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Operator’s Manual · Version 2.0
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Sig.E
33 Data alarms
Alarms for calibrations
>Sig
cobas ® 8000 modular analyzer series
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.
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 does not reach room temperature.
Remedy
1
Replace ProCell.
2
Place the calibrator appropriately.
3
Recalibrate.
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.
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E-54 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations
Slop.E
This section describes the Slop.E flag for ISE modules and for immunological modules.
cobas ISE module
Alarm ISE slope abnormal
Displayed on Calibration > Status > Calib Trace .
Description The slope value is less than 45.0 mV for Na
+ for the Cl
-
electrode.
or K
+ electrodes, or greater than -35 mV
Na + , K + Slop.E
Prep.E
(Normal range) Cond.E
+ 40 + 45 + 50 + 55 + 60 + 65 + 68 mV
Cl Cond.E
(Normal range) Prep.E
Slop.E
Figure E-3
- 68 - 65 - 60 - 45 - 40 - 35 - 30
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 alarm recurs, call technical support.
mV e For more information on ISE calibration alarms, see:
cobas e 602 module
Alarm Slope
Description All measured calibrator values does not fall in ascending (sandwich or bridging principle) or descending (competition principle) order.
Qualitative assays only.
Cause o The ProCell or standard solution is expired.
o The standard solution does not reach room temperature.
Remedy 1 Replace ProCell.
2 Set the standard solution appropriately.
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33 Data alarms
Alarms for calibrations cobas ® 8000 modular analyzer series
Std.E
This section describes the Std.E flag for the ISE module and for photometric modules.
cobas ISE module
Alarm Standard error
Description 1. During ISE calibration, any one of the following alarms was encountered:
Data alarm Data flag
Table E-4
Data alarms causing a Std.E alarm when occurring in calibration
2. During calibration, calculation was disabled.
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 to check the calibration parameters.
5
Resume operation. If alarm recurs, call technical support.
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E-56 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Alarms for calibrations cobas c 701 and c 502 modules
Alarm Standard error
Description 1. During photometric calibration, any one of the following alarms was encountered:
Data alarm Data flag
(a)
Prozone error 1, Prozone error 2 / Kinetic unstable
Reaction limit over (substrate depletion)
Table E-5
Data alarms causing a Std.E alarm when occurring in calibration
(a) Not for Std.1
2. During calibration, calculation was disabled.
3. During nonlinear calibration, an extreme value appeared.
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 to check the calibration parameters.
5
Resume operation. If alarm recurs, call technical support.
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33 Data alarms
Alarms for calibrations
Sys.Err
cobas ® 8000 modular analyzer series
Alarm System error
Description An error occurs on the system during measurement.
Cause Check the Alarm window.
Remedy 1 Eliminate problems with the instrument, referring to the Alarm window.
2 If alarm recurs, call technical support.
Roche Diagnostics
E-58 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Data alarms for controls
Data alarms for controls
This section describes data alarms for controls. The QC results are validated on the data manager. If an alarm is issued it is transferred back and displayed on the control unit.
QCErr1 (1-3S)
Alarm QC error 1 (1-3SD)
Description In Realtime QC, the control X or control Y data value is above 3 SD or below -3 SD.
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.
This check is performed only when RULE 1- 3 SD is selected.
Remedy 1 Check that calibrators, controls, and reagents are properly prepared, positioned, and stored.
2 Check that the mean and SD for the specified assays are entered correctly on
QC > Install .
3 Check that calibrator values are correct, if available, on Calibration > Install .
4 Register a new reagent pack.
QCErr2
Alarm QC error 2 (1-2.5SD)
Description In Realtime QC, the control X value or control Y data value is above 2.5 SD or below
-2.5 SD.
Cause o
The reagent is deteriorated (linearity of working curve degraded).
o One control is concentrated or deteriorated.
This check is performed only when RULE 1- 2.5 SD is selected.
Remedy 1 Register new reagent pack.
2 Prepare a new control. Prepare control X together with control Y and use them for a given period of time.
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33 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.
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cobas ® 8000 modular analyzer series 33 Data alarms
Data problems without alarm
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.
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).
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33 Data alarms
Data problems without alarm cobas ® 8000 modular analyzer series
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.
e
Special Wash submenu on page B-270
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).
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.
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E-62 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 33 Data alarms
Rerun list
Rerun list
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.
e For more information on performing reruns, see
Processing reruns on page B-222
Increase
Normal
Decrease
No rerun
Sample is rerun with an increased sample volume
Sample is rerun with the same sample volume (repeat)
Sample is rerun with a decreased sample volume
No rerun is performed on this module
Flag Alarm ISE c 701 c 502 e 602
AB level range over (Assay Buffer=ProCell)
Cal.E (Sample flag) Calibration result abnormal (Sample flag)
CarOvr Potential microbead carryover
Measuring cell temperature out of range
Unable to calculate compensated test
Data error in compensated test
Measuring cell current range over
Table E-6
Serum index check: interference by hemolysis.
Serum index check: interference by hemolysis and icterus.
Serum index check: interference by icterus.
Serum index check: interference by lipemia.
Serum index check: interference by lipemia and hemolysis.
Serum index check: interference by lipemia, hemolysis, and icterus.
Serum index check: interference by lipemia and icterus.
Rerun list (Sheet 1 of 2)
-
-
-
Normal Yes
Normal Yes
Decrease Decrease Yes
Normal Normal Normal Normal Yes
-
-
Normal Normal Normal Normal Yes
Normal Normal Normal Normal No
-
-
-
-
-
-
Normal Yes
Normal Yes
Normal Normal Normal Normal Yes
Normal Yes
Normal Normal Normal Yes
Normal Normal Normal Yes
Normal Yes
-
-
Normal Yes
Normal Normal Yes
Normal Normal No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
No rerun No rerun No rerun No rerun No
-
Decrease -
Normal -
-
-
-
Normal Yes
-
-
Yes
Yes
Auto rerun
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cobas ® 8000 modular analyzer series 33 Data alarms
Rerun list
Flag
>Test
< Test
Table E-6
Alarm ISE c 701 c 502 e 602 Auto rerun
Prozone error 2 / Kinetic unstable
Reaction limit over (substrate depletion)
Reagent, diluent, or Pre-Treatment film
Reagent, diluent, or Pre-Treatment hovering
Abnormal reagent disk temperature
Repeat limit over (upper / lower)
ABS maximum over (non-lin curve)
Washing buffer short (PreClean)
Washing buffer temperature (PreClean)
Rerun list (Sheet 2 of 2)
Normal -
-
-
-
Decrease Decrease -
Normal Normal -
-
-
Normal Normal Normal -
Normal Normal Normal -
Decrease
Decrease
Decrease
Decrease
-
-
Yes
Yes
Yes
Yes
Yes
Yes
Yes
-
-
No rerun No rerun No rerun No
Normal Yes
Normal Yes
Normal Normal Normal Normal No
-
-
Normal Yes
Normal Normal Normal Normal Yes/No due to setting
Decrease Decrease -
Normal
Yes
Yes
Normal Normal Normal Normal No
-
-
-
-
-
-
-
-
Normal Yes
No rerun No rerun No rerun No rerun No
Normal Normal Normal Normal No
-
-
Normal Yes
Normal Yes
-
-
-
-
Normal Yes
Normal Yes
-
-
-
Normal -
-
-
Normal Yes
Yes
Decrease Decrease Decrease Decrease Yes
Normal Increase Increase No rerun ISE: Yes
-
-
-
c 701: Yes c 502: Yes e 602: No
Normal Yes
Normal Yes
Roche Diagnostics
E-64 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Troubleshooting
34 Troubleshooting
Table of contents
This chapter provides general information about troubleshooting problems on the cobas® 8000 instrument.
Roche Diagnostics
Operator’s Manual · Version 2.0
In this chapter Chapter
34
Cannot access another software submenu ..................................................... E-71
Selecting samples to compare the reaction curves ........................................ E-72
E-65
34 Troubleshooting
Table of contents cobas ® 8000 modular analyzer series
Multiple photometric tests (more than 1 reagent) .............................................. E-83
Inter-assay precision (including both channels within 1 module) ................... E-90
Roche Diagnostics
E-66 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
General troubleshooting
General troubleshooting
Roche Diagnostics
Operator’s Manual · Version 2.0
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
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.
E-67
34 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: e The items are divided into the following categories:
Chemistry problem on page E-68
Immunoassay problem on page E-68
Instrument problem on page E-68
Chemistry problem o account number/customer ID number o instrument serial number o module type, serial number, and software version o test(s) affected and other tests on board o special wash programming o description of the problem including relevant alarm(s) and alarm code numbers 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 software version o module serial number o is problem module or channel specific o one assay or more assays affected and other assays on board o special wash programming o description of the problem including relevant alarm(s) and alarm code numbers o when problem first occurred 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 and software version o description of the problem including relevant alarm(s) and alarm code numbers o other instrument or maintenance related information
Roche Diagnostics
E-68 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
Instrument troubleshooting
Instrument troubleshooting
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 o The instrument must only be connected to a power supply source with the specified power cord and by trained personnel.
o Always make sure that the power switch is in the off position before plugging in the instrument.
Cause or description
1. Instrument is unplugged.
Remedy
Plug instrument power cord into socket.
2. Main circuit breaker (on the rear side of rack sampler unit) in OFF position.
Switch main circuit breaker to the ON position.
Switch on the module power switch.
3. Module power switch for one of the modules is switched off.
4. The circuit breaker for the instrument power line in your facility is in the OFF position.
Have your facility electrician check the appropriate circuit breaker.
5. Control unit workstation power cord is unplugged at the rack sampler unit.
Plug the power cord into the rack sampler unit. If the instrument still does not power up, call technical support.
Table E-7 Troubleshooting at power up
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
Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series 34 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 sampling stop or stop mode. In the sampling 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 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.
Electrical power not available
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.
If you are having problems powering the instrument on, follow the steps below:
1
Are the operation ON/OFF switch and circuit breaker switched OFF?
o
o
2 Switch on both power switches.
3 Is the power cable plug disconnected at either the instrument or the outlet?
o
o
4
Firmly connect the power cable.
5
Is the main power outlet working?
o
o
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.
Roche Diagnostics
E-70 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
Instrument troubleshooting
Cannot access another software submenu
If you are unable to access another software submenu, follow the steps below:
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.
Touchscreen does not come on
If you are having problems with the touchscreen, follow the steps below:
1
Is the operation ON/OFF switch on the front of the touchscreen switched OFF?
o
o
2 Switch the operation switch ON.
3 Is the cable between the touchscreen and the instrument disconnected?
Touchscreen is difficult to see o
o
4
Firmly connect the cable.
5
If you are still experiencing problems, call technical support.
If the content of the touchscreen is difficult to see, follow the steps below:
1 Is the touchscreen dirty?
o
o
2
Gently wipe the surface with a dry cloth.
3
Is the ambient lighting too bright?
o
o
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.
Roche Diagnostics
Operator’s Manual · Version 2.0
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34 Troubleshooting
Instrument troubleshooting cobas ® 8000 modular analyzer series
Probes do not descend to liquid surface
If the sample probes do not descend to the liquid surface, follow the steps below:
1 Are there bubbles on the liquid surface?
o
o
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.
Bubbles in syringes
If you see bubbles in either the reagent and/or sample syringe, follow the steps below:
1 Choose Utility > Maintenance
and select (8) Reagent Prime on the
Maintenance Items list.
2 Select All from the Prime Item box and enter 5 cycles.
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.
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.
a 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
Repeat steps 2 to 4 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.
Roche Diagnostics
E-72 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas ISE module)
Troubleshooting (cobas ISE module)
This chapter provides information about troubleshooting procedures specific to the
ISE module.
Only 1 test shows erratic results
If only 1 ISE channel shows erratic results on one or more samples even after repeating the test, follow the steps below.
1 Check if the wrong sample container was used (i.e., heparin sample tubes).
2 Check for contamination of sample containers.
If only 1 ISE channel shows erratic results that are not repeated, follow the steps below.
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
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 steps below.
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.
Roche Diagnostics
Operator’s Manual · Version 2.0
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cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas ISE module)
All results are erratic, excessive air in sipper syringe
For problems with erratic ISE results and excessive air in the sipper syringe, follow the steps below:
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. Perform an ISE prime of the relevant reagent(s).
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
on the ISE module (Ref).
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 (Ref).
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 (Ref).
5 If problem recurs, call technical support.
Roche Diagnostics
E-74 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Results are erratic
34 Troubleshooting
Troubleshooting (cobas ISE module)
For problems with erratic ISE results, follow the steps below:
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 .
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
on the ISE module (Ref). 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 > Maintenanc e 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.
e
See Processing green wash rack on page D-70.
7 If problem recurs, call technical support.
Roche Diagnostics
Operator’s Manual · Version 2.0
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34 Troubleshooting
Troubleshooting (cobas ISE module) cobas ® 8000 modular analyzer series
High/low internal standard values
For problems with high/low ISE internal standard values, follow the steps below:
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 +
K +
Cl -
130 - 150 mmol/L
4.6 - 5.4 mmol/L
90 - 110 mmol/L o
o
2 Check that the ISE IS is correctly placed on the system.
Replace ISE reagents if required.
e For information about replacing ISE reagents, see:
Loading reagents (cobas ISE module) on page B-106
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, replace the seals and prime the ISE IS.
e
For more information, see Replacing the syringe seals on page D-98
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
+
K +
Cl
-
-90 to -10 mV
-90 to -10 mV
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.
Roche Diagnostics
E-76 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas ISE module)
High sodium or low chloride values
For problems with high sodium and low chloride values, follow the steps below:
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 (IS).
o Recalibrate two times with fresh ISE IS.
o
Rerun the sample.
3
If problem recurs, call technical support.
Low ISE values
For problems with low ISE values, follow the steps below:
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 (IS).
o Recalibrate two times with fresh ISE IS.
o
Rerun the sample.
3
Is the correct compensator value (ISE Comp.) entered under Calibration >
Install > Chemistry ?
If no, correct the compensator value.
4
If problem recurs, call technical support.
Roche Diagnostics
Operator’s Manual · Version 2.0
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34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules) cobas ® 8000 modular analyzer series
Troubleshooting (cobas c 701 and c 502 modules)
This chapter provides information about troubleshooting procedures specific to the c 701 and c 502 modules.
High test results
The following may cause high test results on the c 701 and c 502 modules. Identify the module(s) giving high test results and troubleshoot according to the steps below:
1 Incubation 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 for leaks.
o Replace O-rings and seals.
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.
Roche Diagnostics
E-78 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Low test results
34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules)
The following may cause low test results on the c 701 and c 502 modules. Identify the module(s) giving low test results and troubleshoot according to the steps below:
1 Reagents are expired.
o Prepare new reagents (see package insert on cobas link for stability of the prepared reagent).
2 Reagents were not properly stored.
o Prepare new reagents (see package insert for proper storage).
3 Reagents were not properly prepared.
o Prepare new reagents (see package insert for proper preparation instructions).
4 Incubation 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 not dripping.
13
Check that ultrasonic mixers are operating properly.
14
If you are still experiencing problems, call technical support.
Roche Diagnostics
Operator’s Manual · Version 2.0
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34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules)
Erratic test results
cobas ® 8000 modular analyzer series
The following may cause erratic test results on the c 701 and c 502 modules. Identify the module(s) giving erratic test results and troubleshoot according to the steps below:
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
) and perform an air purge.
e See also
Cleaning the pipetter probes on page D-122.
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.
o 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 incubation bath.
o Check for particles in the incubation bath. If particles exist, perform the incubation cleaning procedure.
e
See: Replacing reaction cells and cleaning incubator bath on page D-137.
o Check for foaming, perform incubation bath exchange.
o
Check for sufficient Hitergent on the module. 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.
e
For more information, see Cleaning cell rinse nozzles on page D-126
8
If you are still experiencing problems, call technical support.
Roche Diagnostics
E-80 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules)
Erratic or biased test results
For problems with erratic or biased test results on c 701 and c 502 modules, identify the module(s) having problems and troubleshoot according to the steps below:
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.
6 If you are still experiencing problems, call technical support.
o Repeat analysis with appropriate sample volume.
Roche Diagnostics
Operator’s Manual · Version 2.0
E-81
34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules) cobas ® 8000 modular analyzer series
Single sample or control
For problems with a single sample or control on the c 701 and c 502 modules, identify the module(s) having problems and troubleshoot according to the steps below:
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 package insert for acceptable sample types. Check the sample collection; check the package insert 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.
Single test (1 reagent)
For repeated or consistent problems with a single test on the c 701 and c 502 modules, identify the module having problems and troubleshoot according to the steps below:
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.
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cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas c 701 and c 502 modules)
Tests with more than 1 calibration point
For problems with tests with more than 1 calibration point on the c 701 and c 502 modules, identify the module(s) having problems and troubleshoot according to the steps below:
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.
Multiple photometric tests (more than 1 reagent)
For problems with multiple photometric tests on the c 701 and c 502 modules, follow the steps below:
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 incubation bath is free of debris and foam. If necessary, perform incubation bath maintenance.
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.
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Troubleshooting (cobas c 701 and c 502 modules)
All photometric tests
cobas ® 8000 modular analyzer series
For problems with photometric tests on the c 701 and c 502 modules, identify the module(s) having problems and troubleshoot according to the steps below:
1 Verify the sample probe(s) is not blocked or does not have barbs at the tip. If necessary, clean 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.
Biased enzyme results
For problems with biased enzymes on the c 701 and c 502 modules, identify the module(s) having problems and troubleshoot according to the steps below:
1
Verify the incubation bath level is above the photometer lens.
2
Verify the incubation 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 necessary, change the syringe seals.
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.
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cobas ® 8000 modular analyzer series 34 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 the steps below:
1 The reagent disk cover is keyed. Is the reagent disk cover properly oriented for placement?
o
o
2
Make sure that the reagent disk cover fits into the key before locking.
3
Is there an obstacle around the cover?
o
o
4 Remove the obstacle.
5 If you are still experiencing problems, call technical support.
Trouble replacing ProCell/CleanCell
If you are having problems replacing a ProCell or CleanCell reagent bottle, follow the steps below:
1
The auxiliary reagent bottles are keyed for proper placement. Are you placing the bottle in its appropriate position?
o
o
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
o
4
Remove the obstacle.
5
If you are still experiencing problems, call technical support.
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34 Troubleshooting
Troubleshooting (cobas e 602 module) cobas ® 8000 modular analyzer series
Trouble replacing PreClean
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.
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).
Erratic test results
Remedy 1 Did you handle the reagents, calibrators, and/or controls according to the package inserts?
2 Perform recommended maintenance.
3 If you are still experiencing problems, call technical support.
Causes o
Foam on sample o Foam on assay reagents o
Foam on controls o Non-recommended sample container used
Remedy 1 Did you handle the reagents, samples, and controls according to package inserts?
2 Perform the recommended maintenance.
3 If you are still experiencing problems, call technical support.
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cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas e 602 module)
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 calibrator events out of one 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.
Remedy
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.
4
Dry the calibrator vial, if it is wet.
5
Check calibrator position.
6
If you are still experiencing problems, call technical support.
Calibration not released e For more information, see:
Duplicates out of limits on page E-87
Monotony not fulfilled on page E-88
Values out of limits on page E-88
Calibration factor out of limits on page E-89
Duplicates out of limits
Causes Foam on calibrator or assay reagents.
Remedy 1 Did you handle the reagents and calibrators according to the package inserts?
2 Perform a new assay calibration (new CalSet).
3 Perform recommended maintenance.
4 If you are still experiencing problems, call technical support.
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34 Troubleshooting
Troubleshooting (cobas e 602 module) cobas ® 8000 modular analyzer series
Monotony not fulfilled
Causes Calibrators not transferred to the correct barcoded calibrator vials.
Remedy 1 Did you handle the reagents and calibrators according to the package inserts?
2 Perform a new assay calibration (new CalSet).
3 If you are still experiencing problems, call technical support.
Missing values
Causes o
Empty calibrator.
o Insufficient volume of calibrator or calibrators.
Remedy 1 Did you handle the reagents and calibrators according to the package inserts?
2 Perform a new assay calibration (new CalSet).
3 If you are still experiencing problems, call technical support.
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.
Remedy 1 Did you handle the reagents, calibrators, and/or controls according to the package inserts?
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.
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Troubleshooting (cobas e 602 module)
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.
Remedy
1
Did you handle the reagents, calibrators, and/or controls according to the package inserts?
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.
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.
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Troubleshooting (cobas e 602 module) cobas ® 8000 modular analyzer series
Remedy 1 Did you handle the reagents, calibrators, and/or controls according to the package inserts?
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.
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).
Remedy
1
Have you handled the reagents, calibrators, and/or controls according to the package inserts?
2
Perform recommended maintenance.
3
If you are still experiencing problems, call technical support.
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.
Remedy 1 Did you handle the reagents, calibrators, and/or controls according to the package inserts?
2 Perform recommended maintenance.
3 If you are still experiencing problems, call technical support.
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cobas ® 8000 modular analyzer series 34 Troubleshooting
Troubleshooting (cobas e 602 module)
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.
Remedy
1
Did you handle the reagents, auxiliary reagents, calibrators, and/or controls according to the package inserts?
2
Perform recommended maintenance.
3
If you are still experiencing problems, call technical support.
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/ES).
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.
Remedy
1
Did you handle the reagents and calibrators according to the package inserts?
2
Perform recommended maintenance.
3
If you are still experiencing problems, call technical support.
This is the last page of Part E.
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Operator’s Manual · Version 2.0
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34 Troubleshooting
Troubleshooting (cobas e 602 module) cobas ® 8000 modular analyzer series
Roche Diagnostics
E-92 Operator’s Manual · Version 2.0
Glossary
F
Glossary
2-dimensional barcode - bound/free separation 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.
Numbers
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.
A 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 target value .
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 system if a QC value is outside a predefined range.
B backup 1. The saving of data onto supplementary storage media such as DVDs or CDs. 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.
blank cell Calibration procedure for ECL instruments performed by Roche Diagnostics service staff.
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.
F-3
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Operator’s Manual · Version 2.0
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
.
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.
auxiliary reagent A non-test specific reagent that is needed to perform testing on an instrument.
cobas ® 8000 modular analyzer series Glossary bridging principle - cell blank 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
.
C calculated result See calculated test.
calculated test A test result calculated from different individual analytical methods with a given formula such as ratio A/B. 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.
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 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 via cobas link 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.
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 NOW A system-generated recommendation to carry out calibration within a forthcoming defined time interval (Remaining time on
Calibration > Status submenu).
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.
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). 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 to another assay.
cassette
cobas c pack , and cobas e pack .
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.
Operator’s Manual · Version 2.0
Roche Diagnostics
F-4
cobas ® 8000 modular analyzer series Glossary cell holder - control material cell holder A container holding the electrode in the electrode measurement 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 wash solution.
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
The umbrella brand name for a broad range of products and services for use in professional IVD laboratories and physician's office settings.
cobas c pack The name given to a reagent pack used on cobas c modules and COBAS INTEGRA
systems.
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 cobas TeleService to exchange information between the Roche service network 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 TeleService The set of software applications that use cobas link to exchange service information between Roche service network and a customer's laboratory. cobas TeleService provides remote monitoring and diagnosis, hotline support, and software and documentation updates.
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 that takes account of known or defined interference factors.
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 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.
control material A material used to assess the performance of an analytical procedure or part of an analytical procedure. Also called the control sample.
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Operator’s Manual · Version 2.0
F-5
cobas ® 8000 modular analyzer series Glossary control name - dynamic range 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.
cumulative QC The accumulated data and associated statistics of individual QC data.
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 Cup) on top of a primary sample tube cycle The instrument time interval during which pipetting or measurement can be carried out.
cyclic QC Controls run at fixed intervals.
D data alarm Printed or displayed notification that occurs if a result (including calibration or QC results) is unexpected or abnormal; an indication of unusual reaction or instrument conditions, for example, insufficient sample or reagent.
data flag See data alarm.
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.
default profile A predefined set of tests that the instrument automatically applies to a sample unless the operator specifies a different set of tests.
demographics Patient-related data such as name, date of birth, and gender.
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 See duplicate limit.
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.
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F-6 Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series Glossary emergency stop - incubation bath
E emergency stop An instrument alarm level that immediately stops all instrument functions.
electromotive force (EMF) The physical principle that provides the basis for electrolyte measurement.
endpoint assay An analytical technique taking measurements after a reaction is completed or has been
.
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.
E.Stop A status indicating that the system has performed an emergency stop. This could be due to hardware failure or because any of the safety devices have requested an emergency stop. The system requires either complete power off, or at least initialization, to resume normal operation.
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.
G 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).
H 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 can be added to the reaction 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 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 communication Data exchange with a clinical laboratory information system (LIS).
Host interface protocol A technical description that defines data transfer between a Host computer and an analytical system.
F 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.
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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.
incubation bath A temperature-controlled, waterfilled reservoir that surrounds the reaction cells. Also called a reaction bath.
F-7
cobas ® 8000 modular analyzer series Glossary incubator - maintenance procedure incubator A temperature-controlled aluminum block for AssayCups on cobas and Elecsys instruments.
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.
input buffer A section of an instrument where samples
are loaded by using a rack or rack tray. See also rack loader
.
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.
L
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 rack loader.
loading capacity The maximum number of samples that can be loaded onto the input buffer.
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.
K
K factor The reciprocal of the slope of the calibration curve. A factor used in conversion of absorbance values to concentration values or activities.
M maintenance item A maintenance procedure performed by the system or the operator.
maintenance key A 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.
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cobas ® 8000 modular analyzer series Glossary manual dilution - multi-wavelength spectrophotometer 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.
masking A function that temporarily suspends the measurement or calibration of a specific test, depending on the condition of the instrument or reagent. Tests can be masked completely, or just for individual modules or channels. There are two possibilities to mask a test: If Tmask 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. Masking can also be applied to entire 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.
measure point Time at which absorbance reading is taken and used to calculate results.
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 range See reportable range.
message In computing, a defined set of alphanumeric data that transfers information from computer to computer or from an analytical instrument to the operator.
microbead Paramagnetic streptavidin-coated microparticles used as the solid phase for heterogeneous immunoassays in ECL systems.
Microcup A secondary sample cup made by Hitachi with a small dead (residual) volume microparticle See microbead.
microbead mixer A paddle or propeller that thoroughly mixes the microbead reagent to ensure resuspension before use.
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. 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.
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cobas ® 8000 modular analyzer series Glossary non-barcode mode - pipe
N non-barcode mode A mode of instrument operation during which the instrument identifies samples by using the rack and position numbers.
normal range See
output buffer A section of an instrument to which samples are moved on completion of the analytical process and from which they can be unloaded. See also
O 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.
one-way serial processing Sample flow and processing along a single, serial process lane that allows no bypass function and no rerun.
Online Help On-screen documentation that a user can request in a context-sensitive manner and search for any given term.
online support A service that supports the preparation for analysis and maintenance management by
exchanging information over networks. See also cobas
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. 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
P-mask See Patient mask.
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 Tmask 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 See open request.
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.
pinch valve A valve that pinches the suction tube and switches the flow path.
piercer A punch on the reagent transfer arm that pierces the reagent bottle seals during reagent pack preparation.
pipe See maintenance pipe.
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cobas ® 8000 modular analyzer series Glossary pipetter - query download 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.
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.
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.
pre-dilution A dilution step performed before samples are analytically processed on the instrument.
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).
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.
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.
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
Q readdition method and reaction rate method.
QC error An alarm generated in realtime QC when either a low value or a high value exceeds the limit of 3SD
(QC error 1) or 2.5 SD (QC error 2).
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 and LIS by which a predefined data set is transmitted upon request of the analytical instrument.
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cobas ® 8000 modular analyzer series Glossary rack - reference electrode
R 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 loader Area where the sample racks to be measured are set (input buffer). 15 racks can be placed on each rack tray and 4 rack trays on the rack loader.
rack pusher arm An arm, located on the loader, for pushing racks.
rack tray A device for carrying and handling racks. It holds up to 15 racks and is placed directly in the rack loader or unloader of the instrument.
rack unloader Area that holds the sample racks whose measurements have completed (output buffer). 15 racks can be stored on each rack tray and 4 rack trays on the unloader.
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 mVolt 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 and cobas e pack .
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. A reagent pack calibration is valid for one specific assay.
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.
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.
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cobas ® 8000 modular analyzer series Glossary reference solution - secondary tube 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 (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 order.
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 See rinse station.
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.
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
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 See rack.
sample tray See rack tray.
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 are settable 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
.
secondary tube A sample container of variable size into which aliquots are transferred
F-13
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cobas ® 8000 modular analyzer series Glossary sequence number - Test mask sequence number A number automatically assigned to each sample by the instrument and used to track samples and orders.
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.
Service System status that is required to perform a maintenance action. See maintenance item, maintenance procedure.
shutter A door, located on the lid of the reagent disk, that is used to load and unload cobas c packs ( 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 reagent 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.
Start up An operational mode of an instrument, following power-on, during which the instrument prepares itself for operation.
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.
SysClean An auxiliary reagent used for the periodic cleaning of the measuring cell.
system cleaning solution See wash solution.
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
.
systematic error An error that is generated by a cause giving deviation to measured values. An alarm generated when control of a low value or a high value is changed in the same direction in realtime quality control.
SysWash A system-specific agent used to avoid reagent carryover. It also prevents bacterial growth.
T
T-mask See Test mask.
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.
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 Tmask 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.
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cobas ® 8000 modular analyzer series Glossary test principle - workarea consolidation 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 See AssayTip.
tip eject station An opening in the instrument housing through which AssayCups and AssayTips are discarded.
tray indication light A status light, at the front of the rack loader and unloader that indicates the mode of operation.
tripropylamine (TPA) One of two electrochemically active substances used in the ECL reaction.
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.
W 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.
This is the last page of Part F.
U ultrasonic mixer A mechanical unit, in a waterproof pack, that generates ultrasound used to stir samples.
unloader An unloader holds sample racks after the completion of the analytical process.
upload The process of sending data to Roche by a network link.
V validation The process of checking results or data against defined rules or ranges in clinical laboratories.
Validation can be against technical or clinical criteria.
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Glossary workarea consolidation - workarea consolidation cobas ® 8000 modular analyzer series
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Index
G
cobas ® 8000 modular analyzer series
Index
Symbols
<>Test (data alarm)
<Sig (calibration alarm)
<SigL (data alarm)
>AB (data alarm)
>Abs (data alarm)
>Curr (data alarm)
>Cuvet (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)
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>Kin (data error)
>Lin (data alarm)
>Proz (data alarm)
>React (data alarm)
>Rept /<Rept (data alarm)
>Sig (calibration alarm)
>Test /<Test (data alarm)
A
AB level
AB.E (data alarm)
Abbreviation
Abnormal Cell List, cell blank measurement, D–130
Abnormal condition, during operation, B–50
Activating
ADC.E (data alarm)
Air ionizer, clean filter, c 701, D–153
Air purge, maintenance item, D–34
G-3
Index
Index
Alarm
– button flashes yellow or red, B–51
– instrument alarm window, B–51
– problems without alarm, E–60
– setting a purple alarm, B–251
– setting a yellow alarm, B–251
Alcohol (ethanol), warning message, D–3
Analysis flow
Analyze parameters
Analyzer
Application
– installing or updating new application, B–257
– parameter description, B–259
– reagents for ISE, B–101, B–102
Application setting
– dilution rations, e 602, B–261
– duplicate limit, e 602, B–264
– qualitative field, c 701 and c 502, B–268
– technical limit, c 701 and c 502, B–267
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G-4 cobas ® 8000 modular analyzer series
Archive
– saving system parameter, B–253
Area
– Module Overview, Overview menu, B–16
– topic area, help system, B–27
Aspiration filter
– cleaning, c701 and c 502, D–146
Aspiration of air, pipetter probes, B–6
Aspiration tube, clean, e 602, D–213
AssayCup
AssayTip
– buffer station, e 602, A–136
Assigning
– control racks for auto QC, B–242
– racks and positions to controls, B–207
– tests to c 701 or c 502, B–281
Asterisk, on maintenance report, D–20
Auto masking
Auto QC buffer
– unloading auto QC racks, B–204
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– rerun, B–62, B–222, B–266, E–7
Timer
Auxiliary reagent
B
Backup
– system parameter, B–231, B–253
Backup Operation
– measuring samples in backup operation mode, B–227
Barcode
– reading sample barcodes, A–72
– types of sample barcodes, A–71
Barcode label
–
–
– on samples, readability, A–72
– on samples, scan range, A–151
– manually assigned rack position, B–62
Barcode reader
– c 502 module, for reagent pack, A–113
– positions on system, safety information, A–27
Barcode reader window, e 602, D–223
Batch mode, sample processing, B–71
see Microbead mixer
Biased result
– c 502 module, troubleshooting, E–81
– c 701 module, troubleshooting, E–81
Bubbles
– on sample, safety message, A–12
Button
C
– barcode reader, reagent pack, A–113
– calibration alarm, Cal.E, E–46
– calibration alarm, Dup.E, E–48
– calibration alarm, S1A.E, E–52
– calibration alarm, SD.E, E–53
– calibration alarm, Sens.E, E–53
– calibration alarm, Std.E, E–57
– calibrators and controls, B–126
– checking calibration results, B–179
– cobas c
pack, unloading and reloading, B–125
– cobas c
– data alarm, >Rept/<Rept, E–29
– data alarm, >Test/<Test, E–30
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Index
Index
– installing application parameter, B–258
– loading auxiliary reagents, B–133
– loading reagent packs, B–129
– minimum sample volumes, A–158
– module overview, A–46, A–107
– photometric system, specifications, A–158
– reaction system, specifications, A–157
– Reagent Overview window, B–128
– reagent pack management system, A–112
– reagent pack, unloading or reloading, B–131
– reagent probe rinse station, A–111
– reagent probe, location, A–111
– reagent storage compartment, A–110
– reagent system, specifications, A–158
– reagents for applications, B–123
– replacing reagent packs, B–129
– review calibration data, B–179
– safety information for operation, B–6
– sample probe rinse station, A–110
– sampling system, specifications, A–158
– troubleshooting, biased enzyme results, E–84
– troubleshooting, biased result, E–81
– troubleshooting, control, E–82
– troubleshooting, erratic results, E–80, E–81
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– troubleshooting, high results, E–78
– troubleshooting, low results, E–79
– troubleshooting, sample, E–82
– troubleshooting, single test, E–82
c 701 and c 502 module maintenance
– calibration alarm, Cal.E, E–46
– calibration alarm, Dup.E, E–48
– calibration alarm, S1A.E, E–52
– calibration alarm, SD.E, E–53
– calibration alarm, Sens.E, E–53
– calibration alarm, Std.E, E–57
– calibrators and controls, B–113
– checking calibration results, B–179
– cobas c
– data alarm, >Rept/<Rept, E–29
– data alarm, >Test/<Test, E–30
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– installing application parameter, B–258
– loading auxiliary reagents, B–120
– loading reagent packs, B–117
– minimum sample volumes, A–155
– photometric system, specifications, A–156
– reaction system, specifications, A–155
– Reagent Overview window, B–115
– reagent pack, unloading or reloading, B–119
– reagent probe rinse station, A–94
– reagent storage compartment, A–93
– reagent system, specification, A–156
– replacing reagent packs, B–117
– review calibration data, B–179
– safety information for operation, B–6
– sample probe rinse station, A–92
– sampling system, specifications, A–155
– troubleshooting, biased enzyme results, E–84
– troubleshooting, biased result, E–81
– troubleshooting, control, E–82
– troubleshooting, erratic results, E–80, E–81
– troubleshooting, high results, E–78
– troubleshooting, low results, E–79
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– troubleshooting, sample, E–82
– troubleshooting, single test, E–82
Cal.E (Calib flag)
Cal.E (Sample flag)
Calc.? (data alarm)
Calculation
Calib. parameters
– assigning calibrator positions, B–167
– automatic calibration, B–155, B–156, B–263
– calibrators for c 502, B–126
– calibrators for c 701, B–113
– calibrators for e 602, B–137
– cancelling calibrations manually, B–164
– cannot be performed, e 602, E–87
– checking calibrations of e 602 tests, B–186
– checking calibrations of ISE tests, B–175
– checking calibrations of photometric tests, B–179
– checking information about installed calibrators,
– cobas c
– cobas e
G-7
Index
Index cobas ® 8000 modular analyzer series
– edit concentration values, B–171
– factor, out of limit, e 602, E–89
– individual calibration, B–157
– loading calibrator data, B–169
– manual calibration, B–155, B–157
– overview over Calibration menu, B–159
– performing calibration and QC, B–55
– quality criteria, e 602, B–184
– requesting calibrations, B–163
– requesting calibrations manually, B–164
– review data, B–175, B–179, B–186
– review results of previous immunological calibrations,
– review results of previous ISE calibrations, B–176
– review results of previous photometric calibrations,
– review results of the most recent photometric calibration, B–181
– selecting tests for start-up calibration, B–165
– setting, auto masking, B–248
– troubleshooting, e 602, E–87
– usage recommendations, B–155
Calibration (overall system), B–155
Calibration and QC Select button, B–52
Calibration Calibrators submenu see
Calibrators submenu
Roche Diagnostics
G-8
Calibration error
Calibration Install submenu see
Install submenu
(Calibration)
Calibration menu
Calibration method
see Status submenu
(Calibration)
Calibrator
– checking information about installed calibrators,
– general handling notice, A–7
Calibrator Load List
Cancel Maintenance button, D–51
Cap, open/close mechanism, e 602, A–130
Capacity
– data storage on control unit, A–148
CarOvr (data alarm), e 602, E–32
Carryover
– high-priority immunoassays, B–82
see Electrode
Cassette
–
cobas c pack
–
Reagent pack
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Cause
– automatic calibration, B–156
Caution, safety classification, A–5
Cell blank
– measure and view results, D–130
Cell Blank Measurement
Cell cleaner
Cell cover, cleaning, c 701 and c 502, D–131
Cell detergent
Cell rinse nozzles
– unclog, c 701 and c 502, D–171
Cell rinse unit
Cell wash
– programming, c 701 and c 502, B–272
– washing reaction cell, c 502, B–272
– washing reaction cell, c 701, B–272
Cell.T (data alarm), e 602, E–33
Changeover
Check
– list of maintenance checks, D–38
– performing maintenance checks, D–18
Check box, software element, B–41
Check digit
– types for sample barcodes, A–150
Checking
– calibrations of e 602 tests, B–186
– calibrations of ISE tests, B–175
– calibrations of photometric tests, B–179
– information about installed calibrators, B–169
– visual check after start-up, B–50
Chemical, general handling notice, A–7
Roche Diagnostics
Operator’s Manual · Version 2.0
Chemistry
– module, programming special wash, B–271
Circuit breaker and fuse, A–15
Class
ClcT.E (data alarm)
CleanCell
– clean aspiration tube filters, D–217
– clean aspiration tubes, D–213
Cleaning
–
– concentrated waste container, ISE, D–75
– incubator bath (c 701 and c 502), D–137
– solutions (e 602), notice message, D–5
Clear
Clot.E (data alarm)
CmpT.? (data alarm)
CmpT.E (data alarm)
cobas c pack
–
Reagent pack
– volume control, c 502, B–125
– volume control, c 701, B–112
cobas c
G-9
Index
Index
cobas c pack medium, c 502, B–123
cobas c pack MULTI, B–111, B–124
– insufficient filling volume, A–11
cobas e
cobas link
Color scheme
– Calibration Status submenu, B–162
– Test Selection submenu, test matrix, B–74
Compensation error
– calculation error, c 502, E–21
– calculation error, c 701, E–21
– calculation error, ISE, E–11
– data error, photometric unit, E–22
Component
– core components, overview, A–51
Computer
Concentrated waste
– empty and clean container, D–75
– volume, specification, A–147
Concept
– calibration concept, c 502, B–177
– calibration concept, c 701, B–177
– calibration concept, e 602, B–183
Roche Diagnostics
G-10 cobas ® 8000 modular analyzer series
– calibration concept, ISE, B–173
– reagent concept, c 502, B–123
– reagent concept, c 701, B–110
– reagent concept, e 602, B–136
Cond.E (data alarm)
Condition
– environmental during transport, A–147
Configuration
Configuring
Consumables
– replace, e 602, B–150, B–151
Container
Contents tab
Control
–
QC
– assign racks and positions, B–207
– general handling notice for controls, A–7
– troubleshooting, c 502, E–82
– troubleshooting, c 701, E–82
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Control unit
Conventions used, operator’s manual, 12
Cooling fan, clean the cooling fans, D–62
Core component
Core unit
Cover
– keep covers closed (caution message), A–11
– missing (e 602), caution message, D–5
– missing (ISE), caution message, D–4
– on reagent disk, does not open/close (e 602), E–85
– safety information for operation, B–3
Cross contamination
–
CSF (cerebrospinal fluid), sample type, B–74
–
Cup adapter
– sample tube alignment with cup adapters, A–67
– sample tube alignment without cup adapter, A–67
Curr.E (data alarm)
Curve
– comparing reaction curve, E–72
Customer
Reaction cell
D
Daily Maintenance button, B–52
Daily maintenance schedule, all modules, D–42
Daily operation
–
Roche Diagnostics
Operator’s Manual · Version 2.0
Data
– calibration, B–175, B–179, B–186
– distribution on the system, A–36
– loading calibrator data, B–169
– patient, display archived data, B–91
– problems without alarm, E–60
Data manager
– editing or deleting sample results, B–87
Database
– backup, maintenance check, D–40
Deactivating
Deaerator, draining the tank, D–64
Decontamination, instrument, A–29
Deleting
Det.S (data alarm)
Detergent
Index
G-11
Index cobas ® 8000 modular analyzer series
Development channel
– register on c 701, B–119, B–132
Deviation
– module to module variance, e 602, E–91
Device
– external, data security, A–13
Window
Diff.E (calibration alarm)
Diluent
Diluted sample
Dilution
Dimension
Disinfectant
– for cleaning instrument surfaces, D–65, D–114, D–187
Dispenser
Disposal
– cobas c
– of control unit components, A–29
Drift
– troubleshooting, e 602, E–86
Dup.E (calibration alarm), E–48
Roche Diagnostics
G-12
Duplicate error
Duplicate limit
– Dup.E calibration alarm, e 602, E–49
– Dup.E data alarm, c 502, E–48
– Dup.E data alarm, c 701, E–48
DVD
– Finalizing a DVD disk, B–230
– Formatting a DVD disk, B–229
E
cobas e pack
– calibration alarm, <Sig, E–54
– calibration alarm, >Sig, E–54
– calibration alarm, Diff.E, E–48
– calibration alarm, Dup.E, E–49
– calibration alarm, Mono.E, E–50
– calibration alarm, Sig.E, E–54
– calibration alarm, Sys.E, E–58
– calibration factor out of limit, E–89
– calibrators and controls, B–137
– checking calibrations, B–186
– cobas e
– consumable components, behind the door, A–140
– data alarm, >Rept/<Rept, E–39
– data alarm, >Test/<Test, E–43
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
– ECL unit, specifications, A–160
– loading auxiliary reagents, B–144
– loading reagent packs, B–142
– magazine waste compartment, A–140
– microbead mixer rinse station, A–130
– minimum sample volumes, A–159
– module overview, A–47, A–127
– module to module variance, E–91
– PreClean bottles, A–138, B–144
– Pre-wash area, rinse station, A–129
Roche Diagnostics
Operator’s Manual · Version 2.0
– reaction system, specifications, A–159
– Reagent Overview window, B–139
– reagent probe rinse station, A–131
– reagent system, specifications, A–160
– reagents for applications, B–136
– replacing reagent packs, B–142
– safety information for operation, B–7
– sample probe rinse station, A–132
– sampling system, specifications, A–159
– sipper probe rinse station, A–132
– solid waste container, A–140
– solid waste, emptying, B–150, B–152
– special wash, programming, B–276
– troubleshooting calibration, E–87
– vortex mixing station, A–136
– waste handling, specifications, A–160
e 602 module maintenance
E.Stop, status explanation, B–213
ECL unit, specifications, A–160
Edited (data alarm)
Editing
Electrical supply
Electrode
– clean ISE electrodes (green rack), D–71
G-13
Index
Index cobas ® 8000 modular analyzer series
– replace ISE electrodes, D–88
– replace ISE REF electrode, D–96
Emptying
– concentrated waste container, D–75
– solid waste, e 602, B–150, B–152
Environment
– conditions during transport, A–147
– conditions, environmental, A–147
– contamination by waste, A–10
Equipment
Erratic result
– c 502 module, troubleshooting, E–80, E–81
– c 701 module, troubleshooting, E–80, E–81
– e 602 module, troubleshooting, E–86
– ISE module, troubleshooting, E–73, E–75
Error
Essential Information Upload, maintenance check, D–40
Evaporation
Expiration date
– Reagent Setting submenu, B–99
Expired
– reagent, incorrect result, B–99
Extended power OFF, e 602, D–229
Extended power off/on pipe, D–27
F
– areas in the help window, B–25
– search recommendations, B–30
Roche Diagnostics
G-14
– searching for information, B–28
Factor
– calibration factor out of limit, e 602, E–89
Fatigue, long hours of operation, A–14
Fill height, sample containers, A–152
Film
– on sample, safety message, A–12
Filter
– aspiration filter, c 701 and c 502, D–146
– aspiration filter, ISE, D–84
– circuit board rack filter, c 502, D–150
– PC/CC aspiration tube filters, e 602, D–217
– radiator filter, c 701 and c 502, D–149
– solenoid valve, c 701, D–156
Finalization
see Data alarm
Flow path
– cleaning, e 602 module, D–208
– wash rack, c 701 and c 502 module, D–119
Foam
– incorrect level, c 701, B–117
– on sample, safety message, A–12
Front view
Function
– key, list of keys (instrument software), B–43
Fuse and circuit breaker, A–15
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
G
Green status lamp
– auxiliary reagents, e 602, B–144
– cleaning magazine drawer, e 602, B–150, D–225
– magazine waste, e 602, A–140
– replacing reagents, e 602, B–144
Green wash rack
Gripper
– consumables area, e 602, A–135
H
Handling of reagents and other working solutions, A–7
HbA1c
– notes for the use of the application, B–221
Help
– areas in the help window, B–25
– buttons in the help window, B–26
– searching for information, B–28
– system, instrument, 11, B–24
High level
High result
High value
High-priority immunoassay, potential carryover, B–82
Roche Diagnostics
Operator’s Manual · Version 2.0
Hotkey
– list of keys (instrument software), B–43
I
ID
Illuminated push button, e 602, B–144
Immunoassay
Inactivating
Inc.T (data alarm)
Incubator
– temperature, data alarm, e 602, E–36
Incubator Bath Cleaning mode, D–138
Status lamp
Infection
– by sample materials
– during maintenance, all modules, D–3
– waste solution and solid waste, e 602, D–224
Information
Initialize, status explanation, B–213
Insoluble contaminants in samples, A–11
Inspection, before start-up or after power-off, B–68
Install submenu (Calibration), B–168
Installation
Installing
– application parameter, B–258
G-15
Index
Index
– special wash parameters, B–278
Instrument
– clean surfaces, e 602, D–239
– general troubleshooting, E–69
Instrument alarm, Alarm window, B–51
Instrument care
status
Insufficient reagent alarm
Interaction
– advanced software interactions, B–33
– basic software interactions, B–33
Inter-assay precision
Interface
Interlock
Internal standard
Intra-assay precision
Introduction
Inventory update
– green buttons, e 602, B–152, D–226
– calibration alarm, Cal.E, E–46
– calibration alarm, Cond.E, E–47
– calibration alarm, IStd.E, E–50
– calibration alarm, Prep.E, E–51
– calibration alarm, Rsp1.E, E–51
Roche Diagnostics
G-16 cobas ® 8000 modular analyzer series
– calibration alarm, Rsp2.E, E–52
– calibration alarm, Slop.E, E–55
– calibration alarm, Std.E, E–56
– calibration, requesting, B–108
– calibrators and controls, B–102
– checking calibration results, B–175
– data alarm, >Rept/<Rept, E–16
– data alarm, >Test/<Test, E–18
– erratic result, E–73, E–74, E–75
– internal standard value, E–76
– Reagent Overview window, B–104
– replace pinch valve tubing, D–94
– replace reference electrode, D–96
– review calibration data, B–175
– safety information for operation, B–5
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
– sipper syringe, air in, E–74
ISE module maintenance
IVD
IVD directive
K
Key
– list of shortcuts (instrument software), B–43
– maintenance button, c 502, A–120
– maintenance button, c 701, A–100
L
Label
– safety label description, A–16
Lamp
– green status lamp, e 602, A–136
LED
–
see Magazine lifter
Liquid flow path cleaning, e 602 module, D–208
Liquid level detection
– Sample LLD data alarms, e 602 module, E–42
Liquid level sensor assembly, inside water tank, D–58
List
Roche Diagnostics
Operator’s Manual · Version 2.0
List box
– software element, B–35, B–39
Load List
– Reagent Load/Unload List, B–54
Loading
– auxiliary reagents, c 502, B–133
– auxiliary reagents, c 701, B–120
– auxiliary reagents, e 602, B–144
– auxiliary reagents, ISE, B–109
– download control data, B–209
Lot
Logoff
Low level
Low result
Low signal level (data alarm), E–41
Low value
M
Magazine
– waste compartment, e 602, A–140
Magazine drawer (e 602), A–140
– replacing AssayCups/Tips, B–150
Main menu
Index
G-17
Index
Maintenance
– concepts, introduction, D–10
– manual and software-controlled, D–10
– performing items and checks, D–18
– periodic replacement of parts, D–52
– possibilities during a shift, B–66
– visual checks after start-up, B–50
Maintenance (c 701 and c 502 module)
– as needed maintenance, D–171
– quarterly maintenance, D–151
– six months maintenance, D–157
– six months maintenance, D–62
Maintenance (e 602 module)
– as needed maintenance, D–213
– quarterly maintenance, D–210
– two weeks maintenance, D–208
Maintenance (ISE module)
– six months maintenance, D–96
– two months maintenance, D–88
Maintenance actions (c 701 and c 502)
– cleaning aspiration filters, D–146
– cleaning cell rinse nozzles, D–126
Roche Diagnostics
G-18 cobas ® 8000 modular analyzer series
– cleaning dust filters (behind front doors), D–149
– cleaning instrument surfaces, D–187
– cleaning rinse station, D–134
– cleaning ultrasonic mixers, D–151
– draining the vacuum tank, D–175
– replacing nozzle tips, D–173
– replacing photometer lamp, D–157
– replacing reaction cells, D–137
– replacing syringe seals, D–163
– unclogging cell rinse nozzles, D–171
– washing reaction parts, D–129
Maintenance actions (c 701 only)
– cleaning filter of air ionizer, D–153
– cleaning filter of solenoid valve, D–156
Maintenance actions (core unit)
– cleaning instrument surfaces, D–65
– cleaning water inlet filter, D–60
– draining deaerator and water trap tank, D–64
Maintenance actions (e 602 module)
– cleaning instrument surfaces, D–239
– cleaning liquid flow path, D–208
– cleaning microbead mixer, D–204
– cleaning mixing and separation stations, D–200
– cleaning PC/CC aspiration tube filters, D–217
– cleaning PC/CC aspiration tubes, D–213
– cleaning PC/CC nozzles, D–195
– cleaning probes and sippers, D–192
– cleaning reagent disk and compartment, D–221
– cleaning rinse stations, D–206
– cleaning solid waste compartment, D–224
– replacing PC/CC reservoirs, D–195
– replacing pinch valve tubing, D–210
Maintenance actions (ISE module)
– cleaning concentrated waste container, D–75
– cleaning instrument surfaces, D–114
– cleaning reagent aspiration filter, D–84
– cleaning rinse station, D–77
– replacing electrodes (Na, K, Cl), D–88
– replacing pinch valve tubing, D–94
– replacing reference electrode, D–96
– replacing syringe seals, D–98
– washing reagent flow path, D–92
Maintenance button
Maintenance checks
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Maintenance interval
Maintenance item
Maintenance items
– performing items and checks, D–18
Maintenance pipe
– pipe and pipe function, differences, D–19
– recommended maintenance pipes, D–26
– weekly pipe, all modules, D–27
Maintenance pipe function, D–19
Maintenance report
Maintenance schedule
– c 701 and c 502 module, D–117
– combined (all modules), D–41
Maintenance type
Manual
– rerun, non-barcode mode, B–79
Marking
– test selection matrix, Test Selection submenu, B–75
Masking
Roche Diagnostics
Operator’s Manual · Version 2.0
Measurement
– request QC measurement, B–200
– request QC measurement, manual, B–202
Measuring area
Measuring channel, assign tests, e 602, B–282
Mechanical safety
Mechanism check, maintenance check, D–38
Menu
– Calibration Calibrators, B–166
– Utility System Configuration, B–279
– Workplace Test Selection, B–73
Menu summary
Method comparison
Microbead mixer
Minimum sample volume
G-19
Index
Index
Mixer
– cleaning vortex mixers, D–200
– consumables area, e 602, A–136
– PreClean area (e 602), A–130
Mixing volume
MIXLOW (data alarm)
MIXSTP (data alarm)
Mode
– barcode or non-barcode mode, B–158, B–194
– explanation of instrument statuses, B–213
– rerun, non-barcode mode, B–79
–
Module
– to module variance, e 602, E–91
– trouble on each channel in module, E–62
– trouble on each module, E–62
Module masking
– performing background maintenance, D–50
Module power off, status for maintenance, D–15
Monitor
Mono.E (calibration alarm)
Monotony
Roche Diagnostics
G-20 cobas ® 8000 modular analyzer series
Moving part
N
NaCl
Navigation pane, F1 Help, B–26
Non-barcode mode, B–158, B–194
Non-standard tube
Notice, safety classification, A–5
Nozzle tips, replace, c 701 and c 502, D–173
O
On-board stability
Online help
Operating conditions, A–7, A–146
Operating time (power on time), D–41
Operation
– calibrating tests during operation, B–161
– daily operation, workflow, B–15
Operator
– troubleshooting responsibility, E–67
Operator time, maintenance, D–12
Operator’s Manual
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Operator-controlled (manual) maintenance, D–12
Option
Other parameters
Out of order
– instrument unused for an extended period of time, A–7
–
Over.E (data alarm)
Overdue, maintenance intervals, D–28
Overview
– reagent level alarm settings, B–252
– Reagent Overview window, c 502, B–128
– Reagent Overview window, c 701, B–115
– Reagent Overview window, e 602, B–139
– Reagent Overview window, ISE, B–104
– Work Flow Guide area, B–15, B–52
P
Parameter
– description of Analyze parameters, B–260
– description of application parameter, B–259
Roche Diagnostics
Operator’s Manual · Version 2.0
– description of Calib. parameters, B–261
– description of Other parameters, B–269
– description of Range parameters, B–265
– installing new application, B–258
– installing or updating new applications, B–257
– installing special wash parameter, B–278
Parameter Download
Parameter Download button, B–52
Parameter group
Patient
Performing
Period check box, maintenance type, D–29
Personal protective equipment, A–6
Photometer
Photometric test
Piercer
Pinch valve
– replace tubing, e 602, D–210
see Maintenance pipe
Pipetter
Power
– power supply, specifications, A–146
– start-up analyzer, manual, B–49
G-21
Index
Index
Power off
– extended, e 602 module, D–229
– note for longtime power off, D–46
– single modules for maintenance, D–15
Power On pipe, introduction, D–19
Power Up
Powering off
Powering on
Precision
– inter-assay precision, e 602, E–90
– intra-assay precision, e 602, E–90
PreClean
– temperature out of range, E–44
– trouble placing bottle, E–86
– vortex mixing station, A–130
Prep.E (calibration alarm)
Preparation, status explanation, B–213
Preparing
Preventive Action
– before routine operation, B–59
Pre-wash area
Printing
Roche Diagnostics
G-22 cobas ® 8000 modular analyzer series
– Reagent Load/Unload List, B–54
Probe
– clean probes, c 701 and c 502, D–122
– clean sample probes, ISE, D–73
– does not descend to liquid surface, E–72
– replace probes, c 701 and c 502, D–178
– wash reagent probe, immune module, B–276
– wash reagent probe, photometric modules, B–271
– wash sample probe, B–274, B–277
Probe check, maintenance check, D–38
ProbeWash
Procedure
ProCell
– clean aspiration tube filters, D–217
– clean aspiration tubes, D–213
Processing
– green wash rack, c 701 and c 502, D–119
Profiles
– assigning tests or profiles to test key, B–243
Programming
– cell wash, c 701 and c 502, B–272
– clear timer programming, B–217
– special wash, chemistry modules, B–271
– special wash, immunological module, B–276
Protective equipment
Protective equipment, label on instrument, A–16
Push button, illuminated (e 602), B–144
Q
QC
–
Control
– assigning control positions, B–207
– automatic measurement, B–193
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
– configuring automatic QC, B–249, B–267
– overview over QC menu, B–195
– performing calibration and QC, B–55
– request QC measurement, B–200
– request QC measurement, manual, B–202
– standby reagent QC, B–192, B–203
– unload QC racks from the auto QC buffer, B–204
– usage recommendations, B–191
Controls submenu
Install submenu (QC)
QC Load List
QC menu
see Run Status submenu
see Status submenu (QC)
QC Violation
– automatic calibration, B–156
Qualification, of operator, A–6
Qualitative field, photometric application parameter,
Quality control
–
Quality criteria
R
Roche Diagnostics
Operator’s Manual · Version 2.0
– correct alignment of sample tubes, A–67
– rerun, assign or delete manually, B–80
– transfer mechanism, caution message, B–4
– unloading QC racks from the auto QC buffer, B–204
– assign control racks for auto QC, B–242
Range
– selecting a data range, B–33
Range parameters, Application submenu, B–265
see Incubator bath
Reaction cell
Reaction cell, cell blank measurement, D–130
Cell
Reaction curve
– comparing reaction curves, E–72
Reaction disk
– e 602 (incubator disk), A–132
Reaction system
– cell rinse nozzles, replace nozzle tips, D–173
– replace reaction cells, D–137
– specifications, c 502, A–157
– specifications, c 701, A–155
– specifications, e 602, A–159
– washing, c 701 and c 502, D–129
Reading, sample barcodes, A–72
Reag.F (data alarm)
Reag.H (data alarm)
G-23
Index
Index
Reag.S (data alarm)
Reag.T (data alarm)
– all modules, introduction, B–95
– auxiliary, e 602, A–138, B–138
– clean aspiration filter, ISE, D–84
– general handling notice, A–7
– ISE applications, B–101, B–102
– load auxiliary, c 502, B–133
– load auxiliary, c 701, B–120
– load auxiliary, e 602, B–144
– reagent types, abbreviations in software, B–97
– registering manually, c 502, B–132
– registering manually, c 701, B–119
– registering manually, e 602, B–143
– registration, module overview, B–95
– standby reagent QC, B–192, B–203
– storage compartment, c 502, A–110
– storage compartment, c 701, A–93
– volume, incorrect result, A–11
Reagent area
Reagent cap open/close mechanism, e 602, A–130
Reagent compartment
Roche Diagnostics
G-24 cobas ® 8000 modular analyzer series
Reagent disk
– cover does not open/close, e 602, E–85
Reagent level
– setting a purple alarm, B–251
– setting a yellow alarm, B–251
Reagent Load/Unload List
Reagent menu
Reagent Overview window
Reagent pack
– multiple with same reagent, c 502, B–131
– multiple with same reagent, c 701, B–119
– reloading, c 502, B–125, B–131
– remaining volume control, B–112, B–125
– unloading, c 502, B–125, B–131
Reagent Preparing
Reagent prime
– before finalization, e 602, D–227
Reagent probe
– does not descend to liquid surface, E–72
– special wash, immune module, B–276
– special wash, photometric module, B–271
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
Reagent syringe
Reagent system
– specifications, c 502, A–158
– specifications, c 701, A–156
– specifications, e 602, A–160
Reagent troubleshooting
Reagents (overall system), B–95
ReagEx (data alarm)
Real-time query mode, sample processing, B–71
Rear view
Recovery of control values, e 602, E–89
Recycling, of the instrument, A–29
Reference electrode
Registering
– reagent manually, c 502, B–132
– reagent manually, c 701, B–119
– reagent manually, e 602, B–143
Registration
– auxiliary reagents, c 502, B–127
– auxiliary reagents, c 701, B–114
– cobas c
– cobas c
pack, c 701, RFID label, B–112
Related topics, help system, B–27
Reloading
– reagent pack, c 502, B–125, B–131
Remaining volume control
– auxiliary reagents, c 502, B–127
– auxiliary reagents, c 701, B–114
Repeat limit
Repeat limit (data alarm)
Roche Diagnostics
Operator’s Manual · Version 2.0
Replacement, periodic replacement of parts, D–52
Replacing
– cell detergents, c 502, B–133
– cell detergents, c 701, B–121
– ISE pinch valve tubing, D–94
– ISE reference electrode, D–96
– PreClean, troubleshooting, E–86
– ProCell/CleanCell, troubleshooting, E–85
– sample probe detergents, c 502, B–134
– sample probe detergents, c 701, B–122
Requesting
– calibrations, B–57, B–163, B–164
– QC measurement, manual, B–202
Rerun
– automatic, B–62, B–222, B–266, E–7
– manual, non-barcode mode, B–79
– rack, assign or delete manually, B–80
Restoring
Result data
Results
– editing or deleting sample results, B–87
– erratic, ISE module, E–74, E–75
G-25
Index
Index
Reviewing
– calibration data, B–175, B–179, B–186
Rinse station
– cleaning, c 701 and c 502, D–134
– microbead mixer, e 602, A–130
Routine operation
Rsp1.E (calibration alarm)
Rsp2.E (calibration alarm)
Rules
Run
Running time (power on time), D–41
S
S.Stop
S1A.E (calibration alarm)
Safety information
Roche Diagnostics
G-26 cobas ® 8000 modular analyzer series
– general safety information, A–3
Safety label
– positions on e 602, front view, A–22
– positions on e 602, rear view, A–26
– positions on e 602, top view, A–20
– positions on ISE and c modules, front view, A–21
– positions on ISE and c modules, rear view, A–25
– positions on ISE and c modules, top view, A–18
– positions on the instrument, side view, A–24
Samp.? (data alarm)
Samp.B (data alarm)
Samp.C (data alarm)
Samp.H (data alarm)
Samp.O (data alarm)
Samp.S (data alarm)
Sample
– clot (data alarm), e 602, E–40
– comparing reaction curves, E–72
– container, A–64, A–65, A–152
– container, fill height, A–152
– contamination, foreign material, B–4
– correct alignment of tubes on a rack, A–67
– general handling notice, A–7
– hovering (data alarm), e 602, E–40
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
– minimum volumes, c 502, A–158
– minimum volumes, c 701, A–155
– minimum volumes, e 602, A–159
– mismatch, non-barcode mode, B–4, B–62
– processing STAT sample, B–61
– reruns with diluted samples, B–224
– results, editing or deleting, B–87
– selection list, Data Review submenu, B–82
– tracking on the analyzer, B–64
– troubleshooting, c 502, E–82
– troubleshooting, c 701, E–82
– tube alignment with cup adapter, A–67
– tube alignment without cup adapter, A–67
– volume, decreased/increased, E–63
Sample cleaner
Sample clogging (data alarm)
Sample Data Clear
sample probe
Sample probe
– not descending to liquid surface, E–72
– replacing detergents, c 502, B–134
– replacing detergents, c 701, B–122
Sample syringe
Sample Tracking button
Sample volume
– incorrect definition, micro cups, B–4
Roche Diagnostics
Operator’s Manual · Version 2.0
Sampling area
Sampling stop (Rack Reception), B–63
Sampling system
– specifications, c 502, A–158
– specifications, c 701 module, A–155
– specifications, e 602 module, A–159
Maintenance schedule
Screen
– cannot access another screen, E–71
SD.E (calibration alarm)
Search tab
Searching
Selecting
– tests, start-up calibration, B–165
Sens.E (calibration alarm)
Setting
Expiration date
Shortcut key
Sig.E (calibration alarm)
Signal
– maximum (calibration alarm), e 602, E–54
– minimum (calibration alarm), e 602, E–54
Sipper
– probe for measuring channels, e 602, A–132
Skin inflammation, by reagent or other solution, A–9
SLLD.E (data alarm)
G-27
Index
Index
SLLD.N (data alarm)
Slop.E (calibration alarm)
Sodium
Software
– areas in user interface, B–12
– component, cobas
– component, control unit, A–37
– component, data manager, A–35
– components of the analyzer, A–35
– design and functionality, B–33
– elements, list box, B–35, B–39
– elements, menu and submenu, B–34
– elements, parameter group, B–35
– elements, window, B–36, B–42
Software-controlled maintenance, D–12
Solenoid valve, clean, c 701, D–156
Solid waste
– clean compartment, e 602, D–224
– emptying, e 602, B–150, B–152
Solution
–
Spare parts, periodic replacement, D–52
Special wash
– installing parameters, B–278
– programming, chemistry modules, B–271
– programming, immune modules, B–276
– reaction system, c 502 module, B–125
Roche Diagnostics
G-28 cobas ® 8000 modular analyzer series
– reaction system, c 701, B–112
– reaction system, e 602, B–137
– electric power supply, A–146
– environmental condition, A–147
– reaction system, c 502, A–157
– reaction system, c 701, A–155
– reaction system, e 602, A–159
– reagent system, c 502, A–158
– reagent system, c 701, A–156
– reagent system, e 602, A–160
– sampling system, c 502, A–158
– sampling system, c 701 module, A–155
– sampling system, e 602 module, A–159
– waste handling, e 602, A–160
Spilled liquid
Standby reagent QC
Standard tube
Standby
– status for maintenance, D–14
Start
– start analysis, safety information, A–15
Start-up
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
– time, set time switch, B–216
STAT
– processing STAT sample, B–61
– requesting test manually, B–76
Status
– explanation of instrument statuses, B–213
– for background and parallel maintenance, D–48
– for maintenance, introduction, D–14
– green lamp on drawer, e 602, A–136
– green status lamp, e 602, B–144
– maintenance schedule, c 701 and c 502, D–117
– maintenance schedule, e 602, D–191
– maintenance schedule, ISE module, D–69
Status submenu (Calibration), B–162
– requesting calibrations, B–163
Status submenu (Reagent), B–100
Std.E (calibration alarm), E–56
Stop
– sampling (Rack Reception), B–63
Submenu
Supernatant, sample type, B–74
Support
– calling technical support, E–68
Surfaces
– cleaning (c 701 and c 502), D–187
Symbol
Syringe
Syringe seal
– replace syringe seals, c 701 and c 502, D–98, D–163
Sys.E (calibration alarm)
Roche Diagnostics
Operator’s Manual · Version 2.0
– liquid flow path cleaning, e 602, D–208
SysR.S (data alarm)
SysR.T (data alarm)
System
– parameter programming, B–235
– parameter, stored by Parameter Read/Write, B–254
– reagent pack management, c 502, A–112
System Configuration submenu, B–279
Overview menu
System time, maintenance, D–12
Tab
T
Technical limit
– change, c 701and c 502, B–267
– data alarm, e 602 module, E–43
Technical support, calling, E–68
Test
– activate control tests, B–210
– assigning tests or profiles to test key, B–243
– calibrating tests during operation, B–161
– checking calibrations of immunological tests, B–186
– checking calibrations of ISE tests, B–175
– checking calibrations of photometric tests, B–179
– defining automatic rerun, B–266
– inactivate control tests, B–210
– multiple photometric tests, E–83
– selecting tests for standby reagent QC, B–203
– selecting tests for start-up calibration, B–165
G-29
Index
Index
– Test Selection submenu, B–74
Test results list
Test Selection submenu
Text box
Time
– set present time and day, B–214
Timeout
see AssayTip
Top view
Touchscreen
Training
– environmental condition, A–147
Trouble
– attributed to characteristics of reagent, E–62
– on each analytical module, E–62
– on each channel in same module, E–62
– general instrument troubleshooting, E–69
Roche Diagnostics
G-30 cobas ® 8000 modular analyzer series
– operator’s responsibility, E–67
Type
– barcode types for samples, A–71
U
Ultrasonic mixer
Unloading
– QC racks from the auto QC buffer, B–204
– rack reset, maintenance item, D–33
– reagent pack, c 502, B–125, B–131
Unreadable sample barcodes, B–78
Updating
Upload, essential information, maintenance check, D–40
Urgent Information, maintenance check, D–40
User interface
–
Utility Application submenu see
Application submenu
see Maintenance submenu
– System Configuration submenu, B–279
see Special Wash submenu
Utility System Configuration submenu
see System
Configuration submenu
see System submenu
Operator’s Manual · Version 2.0
cobas ® 8000 modular analyzer series
V
Vacuum
Vacuum tank
– draining, c701 and c 502, D–175
Validating
Validation
Value
– edit concentration value, B–171
– internal standard, high/low, E–76
Variances
Version
Version, of instrument software, D–38
Viewing
Virus
Visual checks, after start-up, B–50
Volume
– minimum sample volume, c 502, A–158
– minimum sample volume, c 701, A–155
– minimum sample volume, e 602, A–159
Volume control
– cobas c
– cobas c
Vortex mixing station, PreClean area, A–130
W
Warning, safety classification, A–5
Wash rack
Waste
– cleaning drain port, ISE, D–80
Roche Diagnostics
Operator’s Manual · Version 2.0
– empty and clean container, D–75
– emptying solid waste, e 602, B–150, B–152
– ISE waste solution (label), A–24
– solid waste container, e 602, A–140
– volume, specification, A–147
Water inlet filter
Water tank
Water trap, draining the tank, D–64
Wavelength
WB.S (data alarm)
WB.T (data alarm)
WEEE, disposal of components, A–29
Weekly pipe, all modules, D–27
Window
– software element, B–36, B–42
Workplace
– overview over Workplace menu, B–72
Workplace menu
– Test Selection submenu, B–73
This is the last page of Part G.
Index
G-31
Index cobas ® 8000 modular analyzer series
Roche Diagnostics
G-32 Operator’s Manual · Version 2.0
Revisions
H
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Key Features
- Full automation of sample preparation, analysis and result reporting
- Continuous sample loading and STAT sample handling
- Integrated ISE sensors for a wide range of electrolytes and pH measurements
- Flexible test menu with a wide range of electrolyte and pH tests
- Comprehensive data management and quality control software
