Instructions For Use
Volume 1
UniCel® DxC Synchron®
Clinical Systems
For In Vitro Diagnostic Use
This manual is intended for
UniCel® DxC 600
UniCel® DxC 800
UniCel® DxC 600i
A13914AF
April 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
Instructions For Use
UniCel DxC Synchron Clinical Systems
PN A13914AF (April 2010)
Copyright © 2010 Beckman Coulter, Inc.
Trademarks
Following is a list of Beckman Coulter trademarks
• AccuSense®
• Array®
• Microtube™
• SPINCHRON™
• Synchron®
• Synchron LX®
• UniCel®
All other trademarks are the property of their respective
owners.
Find us on the World Wide Web at:
www.beckmancoulter.com
Beckman Coulter Ireland, Inc.
Mervue Business Park, Mervue Galway, Ireland 353 91 774068
Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda
Estr dos Romeiros, 220 - Galpao G3 - Km 38.5
06501-001 - Sao Paulo - SP - Brasil
CNPJ: 42.160.812/0001-44
製造販売元 : ベ ッ ク マ ン・ コ ール タ ー株式会社
東京都江東区有明三丁目 5 番 7 号
TOC 有明ウエ ス ト タ ワー
贝克曼库尔特有限公司,
美国加利福尼亚州,Brea 市,S. Kraemer 大街 250 号,
邮编:92821 电话:(001) 714-993-5321
Revision History
Initial Issue, A13914AA, 12/04
Software version 1.0
A13914AB, 10/05
Software version 1.4
A13914AC, 6/07
Software version 2.0
A13914AD, 2/08
Software version 3.0
A13914AE, 12/08
Software version 4.0
A13914AF, 4/2010
Software version 4.0
Changes:
Safety Notice:
• Added statement to Environmental Conditions Precautions
• Added Patient Results
• Added Quality Control
• Added Sample Integrity
CHAPTER 3, System Setup Options:
• Added footnotes to Table 3.3, UniCel DxC 600 Predefined Special Calculation Formulas and
Table 3.4, UniCel DxC 800 Predefined Special Calculation Formulas
CHAPTER 9, Maintenance:
• Added Twice Weekly bullet to Maintenance Schedule
• Added Twice Weekly Maintenance
• Added bullets to Weekly Maintenance
• Added Twice Weekly Maintenance procedure
• Added cleaning statement to Weekly Maintenance
• Added statement to Clean Flow Cell, Cups and CC Probes/Mixers (Automated)
• Deleted CC Probes/Mixers Cleaning (Manual Program) procedure
A13914AF
iii
Revision History
iv
A13914AF
Safety Notice
Summary of Hazards
Introduction
This section summarizes the hazards associated with the DxC System. Individual hazards associated
with a specific procedure in this manual are included in Warnings or Cautions within the procedures
for that task. Please read this section and the following Summary of Precautions before operating
the system.
Bar Code Reader Hazards
Do not tamper with or remove the housing of any bar code reader because of the laser-based nature
of the readers and the potential hazard of looking directly at laser light. When the instrument is
running, homing, or in diagnostics, the laser may be ON. At all other times the laser is OFF.
Biohazardous Materials Hazards
A011460L.EPS
Observe all laboratory policies or procedures which pertain to handling of infectious and
pathogenic materials.
Closed Tube Sampling (CTS) Cap Piercer Assembly Hazards/Biohazards
The Cap Piercer contains a razor sharp blade assembly that has been exposed to potentially
biohazardous fluids. The points of the Blade are very sharp and extend below the Wash Tower. Stay
away from the bottom of the Wash Tower. To prevent injury or exposure, do not touch the Points of
the Blade and always wear gloves.
CTS Auto-Gloss Handling Hazards
Be careful when handling the bottle of CTS Auto-Gloss. Prevent spills. This lubricant is extremely
slippery and difficult to clean from the floor.
Electrical Ground Hazards
Do not under any circumstances operate the system until an electrical ground is provided and the
power cord is properly connected to the ground.
A13914AF
v
Safety Notice
Summary of Hazards
Electric Shock Hazards
Replacement or servicing of any components where contact with bare, live hazardous parts could
occur, possibly resulting in electric shock, should only be performed by qualified service personnel.
Flammable Materials Hazards
Do not use this system in the presence of flammable materials.
Hazardous/Biohazardous Substances Hazards
When handling a spill of blood or other potentially hazardous substances, clean up the spill by using
a 10% bleach solution, or use your laboratory decontamination solution. Then follow your
laboratory procedure for disposal of hazardous materials. If the UniCel DxC system needs to be
decontaminated, call your Beckman Coulter Service Representative for assistance.
ISE Module Hazards
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
Moving Parts Hazard
CAUTION
TO REDUCE RISK OF PERSONAL INJURY,
OPERATE ONLY WITH ALL COVERS IN PLACE.
456161-B
A011459L.EPS
Do not place hands near any moving part while the system is operating. Lower and/or close
protective guards and covers during operation.
No Foam Reagent Pressurization Hazard
The No Foam container is pressurized during system operation and must be properly depressurized
prior to servicing to avoid sudden depressurization and potential exposure of the skin or eyes to the
No Foam solution. To release the air pressure, disconnect the white quick connector located at the
supply side of the container. If inhaled, move exposed individual to fresh air. If skin or eye contact
with the solution occurs, flush the affected area thoroughly with water for at least 15 minutes. In
both cases seek medical attention. Refer to the No Foam Material Safety Data Sheets (MSDS) for
additional information.
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A13914AF
Safety Notice
Summary of Hazards
Power Cord Hazards
Only use a three-pronged power cord to connect the instrument to a matching three-wire grounded
outlet. Do not use an adapter to connect the power plug to a two-pronged outlet.
Service Procedures Hazards
Disconnect the power cord when performing service procedures such as replacing electronic or
mechanical components.
Always wear appropriate personal protective equipment when handling reagents and other
chemical preparations used with the system.
Sodium Azide Preservative Hazards
Reagents, calibrators and controls used with the system may contain small quantities (< 0.1%) of
sodium azide preservative. Sodium azide preservative may form explosive compounds in metal
drain lines. Refer to National Institute for Occupational Safety and Health Bulletin: Explosive Azide
Hazards (8/18/76). Avoid skin contact with reagent by using personal protective equipment. If
contact on skin occurs, use water to wash reagent from skin. Refer to the related Material Safety
Data Sheets (MSDS) for additional information.
System Motors Hazards
To prevent possible injury, press the STOP button on the DxC System to disable the motors before
attempting to clear any jams.
System Operations and Specifications Hazards
System operation should be consistent with the power requirements as stated in the Summary of
Hazards section of this chapter, and should always conform to the procedures and safety warnings
throughout this manual.
If the equipment is used in a manner not specified by Beckman Coulter, Inc., the protection provided
by the equipment may be impaired.
Waste B Disposal Hazards/Biohazards
The Waste B collection bottle contents are considered biohazardous and should be handled
appropriately.
A13914AF
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Safety Notice
Summary of Precautions
Summary of Precautions
Introduction
This section summarizes the precautions that should be taken when operating the DxC System.
Individual precautions associated with a specific procedure in this manual are included in Caution
boxes within the procedures for that task. Please read this section and the preceding Summary of
Hazards before operating the system.
AccuSense Glucose Sensor Precautions
Whenever the sensor is replaced, reaction cup and stir bar cleaning is recommended. Remove the
sensor prior to removing stir bar. To prevent damage to the glucose oxygen sensor membrane tip,
do not insert the stir bar removal tool, applicator stick, or any other object into the glucose reaction
cup unless the sensor has been removed. Do not touch membrane tip of the AccuSense glucose
oxygen sensor.
Air Filter Cleaning Precautions
Do not place a damp filter back on the system. Residual moisture may damage the system.
Alkaline Buffer Stability Precautions
The alkaline buffer reagent is stable for one month on the system. However, if a color change from
pink to a lighter shade of pink should occur, replace the alkaline buffer with a fresh bottle of
reagent.
Aqueous Calibrator Precautions
Repetitive refrigeration of Synchron aqueous calibrators may facilitate crystal formation. When
removed from refrigerated storage, these calibrators should remain at room temperature. After the
calibrator is opened it is stable for the period claimed in the accompanying package insert.
Bar Code Label Precautions
A misread label can cause one sample ID to be read as another. The laboratory’s process for printing,
placing, and meeting all bar code specifications is important to achieve highly accurate readings.
Always follow the bar code label specifications to avoid misread labels.
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A13914AF
Safety Notice
Summary of Precautions
Beckman Coulter Microtube Precautions
• Beckman Coulter Microtubes are designed for use on specific Synchron systems. Using the
appropriate Microtube is essential for proper system operation.
• The sample height in the Microtube is critical for correct sample aspiration on all Synchron
systems.
• The use of Array Microtubes (PN 448163 or PN 448162) on Synchron Systems or the use of
Synchron Microtubes (PN 756776) on Array systems may result in short sampling, incorrect
results, and/or sample probe damage.
• The use of non-Beckman Coulter, third party Microtubes, which have not been designed and
tested on Synchron Systems may result in system damage and/or short sampling.
Biohazard Precautions
All biohazard precautions should be observed when doing maintenance, service, or troubleshooting
on the system. Always wear appropriate personal protective equipment, and wash hands after
working on contaminated portions of the system.
Blood Barrier Collection Tube Precautions
When blood collection tubes that contain physical barriers are used, extra care should be exercised
to ensure that the barrier is tightly packed. Loose particles from the barrier could coat or plug the
sample probe, flow cell, chemistry modules, electrolyte injection cup (EIC), or cuvette wash station.
BUNm/UREAm Electrode Precautions
To prevent damage to the BUNm/UREAm electrode, do not insert the stir bar removal tool,
applicator stick, or any other object into the BUNm/UREAm cup unless the electrode has been
removed. Remove the electrode before you remove the stir bar.
CC Subsystems Priming Precautions
If any two of the CC Subsystem items are selected, all three are primed automatically. Make sure that
all three areas are ready to be primed.
CO2 Membrane Replacement Precautions
Do not touch the membrane surface when installing the quad-ring.
Covers, Doors and Shields Precautions
To ensure optimum performance of the system, operate the system with reagent doors and all
shields and covers in place. To prevent possible motion errors, verify the proper positioning of any
removed and reinstalled cover or shield.
A13914AF
ix
Safety Notice
Summary of Precautions
CTS (Closed Tube Sampling) Cap Piercer Precautions
Use only validated sample containers with the CTS to avoid level sense errors.
CTS Tracking Loss Precautions
For systems with 1-Blade CTS, if there is an unusual loss of network communication, follow the
instructions in the message that appears.
• A normal shutdown or reboot does NOT give this CTS message.
• When there is no CTS Tracking, if the cap were kept on a previously-pierced tube:
— it would be pierced again and
— pieces of rubber could fall into the sample.
• A notification appears when full CTS Tracking is restored.
Diethylamine HCL and the Calcium ISE Precautions
Do not use controls containing diethylamine HCL. This adversely affects the calcium Ion-Selective
Electrode (ISE).
Electrostatic Discharge (ESD) Precautions
To prevent damage due to electrical static discharge (ESD), always wear the wrist ground strap when
directed to in a procedure.
Environmental Conditions Precautions
Changes in ambient temperatures and environmental conditions may result in a "reference drift"
message. In this case, the electrolyte chemistries must be recalibrated.
Studies have shown that NA (sodium) recovery could drift as much as 0.8 mmol/L for each degree
Celsius change in laboratory room temperature, from calibration to the time the sample is tested.
Therefore, laboratory temperature fluctuations need to be minimized.
Fibrin Clots Precautions
Samples should be free of all visible fibrin. Clots could coat or plug the sample probes, flow cell,
chemistry modules, electrolyte injection cup (EIC), or cuvette wash station leading to instrument
malfunction and/or short sampling.
x
A13914AF
Safety Notice
Summary of Precautions
ISE Reagent Precautions
Failure to operate the system with sufficient ISE reagent causes erroneous chemistry results. In
some cases, results are obtained without reagents. Therefore, before starting a run, make sure that
sufficient reagent is available to complete the run.
MC Reagent Stir Bar Precautions
When cleaning the MC Reagent Lines, Cups, and Stir Bars, the stir bar may rise in the cup due to air
accumulation in the lines. Verify that the stir bar is positioned down into the bottom of the cup.
Motion Error Precautions
If the same motion error occurs repeatedly, refer to the instructions in the correct section of
CHAPTER 5, Troubleshooting, of the UniCel DxC Synchron Clinical Systems Reference Manual or
CHAPTER 12, Troubleshooting Calibration and Result Errors of this manual. If the motion error
continues, contact your Beckman Coulter representative.
Narrow Margin Bar Code Precautions
The sample bar code reader on the DxC System can read narrow-margin bar codes. Because of the
sensitivity needed to read narrow-margin bar codes, the labels must be high quality. They must be
free from smudges, spots or other imperfections. An imperfection could be read as part of the
Sample ID. This could cause an inaccurate read of the bar code.
Obstruction Detection and Correction (ODC) Precautions
Disabling ODC inactivates sample handling safeguards and may compromise sample integrity and
cause erroneous results.
Patient Results
Patient results should be reviewed using delta checks. Please be aware of and question sequential
abnormal results.
Printed Reports Precautions
Based on the system’s units/precision setup, a result may be printed as either “high” or “low” even
though the value on the report is within the defined limits. This is due to the rounding of results.
For example, a potassium result of 5.14 mmol/L may be printed as 5.1 mmol/L in the “High” Result
column in a patient report when its reference range is defined as 3.5 to 5.1 mmol/L. The potassium
result of 5.14 mmol/L is greater than the upper reference range limit of 5.10 mmol/L but the value
printed is rounded to 5.1 mmol/L due to the units/precision set up on the system.
A13914AF
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Safety Notice
Summary of Precautions
Quality Control
Laboratory Quality Control practices should be commensurate with laboratory operations. Refer to
assay Instructions for Use and CLIA '88 (update 1/24/2004 Section 493.1256).
Racks Replacement Precautions
Racks should be replaced every five years. Damaged racks should not be used on the system or in
the SPINCHRON Centrifuge.
Ratio Pump Quad-Ring Replacement Precautions
Be careful not to twist quad-rings or O-rings during installation, as this could result in reagent
leakage or ratio pump failure.
Reagent Volume Precautions
Check reagent volumes before you start a run. Failure to operate with sufficient reagent causes
erroneous chemistry results. In some cases, results are obtained without proper amounts of
reagents in the modules. Therefore, before you start a run, make sure that sufficient reagent is
available to complete the run.
Modular chemistry reagent containers should not be handled while the system is performing
modular chemistry measurements.
The use of expired reagents may cause erroneous results.
Residual Blood Contamination Precautions
Before you place your validated closed tubes on the DxC System, check the top of the cap for any
residual blood. Residual blood contamination into the sample could affect results. If blood is
present, remove it by using a cotton-tipped applicator stick moistened with DI water. When running
in the CTS mode, if tubes off-loaded from the UniCel DxC Systems have water or droplets of water
on the caps, disable the CTS and the contact the Beckman Coulter Support Center.
NOTE Oil on a cap is normal.
Reuse of Sample ID Precautions
If your LIS or normal workflow requires the reuse of sample IDs, the sample programming should
be cleared from the DxC at a time interval that is less than the shortest time of sample ID reuse.
Failure to observe this warning causes new requests to be merged with tests from incomplete
samples that previously used that ID.
xii
A13914AF
Safety Notice
Summary of Precautions
Sample Bar Code Reader Precautions
Do not tamper with or remove the housing of the Sample Bar Code Reader.
Sample Integrity
To assure good sample integrity, review pre-analytical sample procedures with your nursing,
phlebotomy and laboratory staff. Follow your tube manufacturer's handling procedures. Contact
the sample tube manufacturer for educational materials and training.
Sample Syringe Replacement Precautions
When installing the syringes, do not mix the two different syringe sizes. The MC and CC sample
syringes (100 μL) are located on the back wall of the instrument. The CC reagent syringe (500 μL) is
located on the right side of the instrument.
Samples NOT Received by Host Precautions
Do not clear samples until results are received at the host or printed. Clearing samples manually or
through host programming, may cause results to be received at the host and printed at the DxC
without the sample ID. Depending on the host implementation, this can cause lost sample results or
sample results which merge with other sample results producing duplicate tests or added tests.
Sample Use Precautions
Do not use the same sample run on a DxC system for analysis of analytes for which a small quantity
of carryover could greatly increase the results (for example, TBhCG).
If your system has a Closed Tube Sampling (CTS) option, place low volume samples in a nesting cup
in a tube using a reserved rack to prevent motion errors.
System Backup Precautions
After inserting a diskette into the disk drive, selecting OK when prompted prepares the diskette by
ERASING it before copying data. Be sure the diskette does not contain critical data that is not
available from another source.
System Configuration Change Precautions
Changes to the System Configuration Data should only be done at the request or at the direction of
Beckman Coulter, Inc. Entry of incorrect information leads to system errors.
A13914AF
xiii
Safety Notice
Summary of Precautions
System Restore Precautions
System Parameter and Alignment data can be restored from the backup diskettes onto the system;
however, performing the Restore function deletes some or all files (depending on the areas
restored) from the hard drive.
Urine Sample Precautions
After analysis of ten consecutive urine electrolytes, run one replicate of electrolytes on Synchron
Calibrator Level 2 in the serum mode. This minimizes the potential for chloride drift due to matrix
effects of urine samples.
xiv
A13914AF
Safety Notice
Hardware Symbols and Labels
Hardware Symbols and Labels
Introduction
This section briefly describes symbols and labels used on the DxC Systems. They are affixed to the
appropriate components of the system.
Instrument Power Switch, ON
This symbol located on the main power switch indicates that the analyzer power is ON when this
portion of the switch is in the down position.
Instrument Power Switch, OFF
This symbol, also located on the main power switch, indicates that the analyzer power is OFF when
this side of the switch is in the down position.
Instrument or Printer Power Switch, ON
This symbol is located on the analyzer and printer power switch. When the portion of the switch
with this symbol on it is in the down position, power to the monitor or printer is ON.
A13914AF
xv
Safety Notice
Hardware Symbols and Labels
Monitor Switch, ON/OFF
This symbol is located on the monitor power switch. A green light to the left of this symbol indicates
the power is ON.
CPU Power OFF Switch
This symbol is located on the face of the Computer (CPU) unit and indicates the OFF state when
pressed.
Primary Electrical Ground
This symbol is used to indicate an electrical ground.
Keyboard Connection
This symbol is found above the connection between the computer and the keyboard.
xvi
A13914AF
Safety Notice
Hardware Symbols and Labels
Can Hold This Object Here
This black symbol, located on the bottom of each sample and reagent probe assembly, indicates that
this area may be handled to rotate the probe.
Do Not Hold This Object Here
This red symbol, located on the top of each sample and reagent probe assembly, indicates that this
area may not be handled.
Mouse Port Connection
This symbol is found next to the connection between the computer and the mouse port.
High Voltage Electric Shock Risk
This symbol indicates high voltage is present and /or there is a risk of electric shock when working
in this area.
A13914AF
xvii
Safety Notice
Hardware Symbols and Labels
CAUTION
This symbol indicates a caution message and is followed by an explanation or other symbols that
define the caution (see examples below).
CAUTION Operate with All Covers in Place
This symbol is located on top of the work surface cover and the cover of an optional Cap Piercer. It
indicates a caution to operate only with all covers in place to reduce risk of personal injury or
biohazard.
CAUTION
TO REDUCE RISK OF PERSONAL INJURY,
OPERATE ONLY WITH ALL COVERS IN PLACE.
456161-B
A011459L.EPS
General Biohazard
These caution symbols indicate biohazardous risk from possible patient specimen contamination.
A011460L.EPS
Laser Bar Code Caution
A label reading, "CAUTION. LASER LIGHT ACCESSIBLE. WHEN COVER IS OPEN OR REMOVED, DO NOT
STARE INTO BEAM." is placed on the cover of any laser-based code reader. Do not stare into laser
light beam when cover is open or removed.
xviii
A13914AF
Safety Notice
Hardware Symbols and Labels
Class II Laser Caution Warning
A label reading, "CAUTION. LASER LIGHT - DO NOT STARE INTO BEAM. 670 nm - 1mW CLASS II LASER
PRODUCT." is placed near any opening through which a bar code reading beam is emitted. Do not
stare into laser light beam.
Laser
A label reading, "AVOID EXPOSURE. LASER LIGHT IS EMITTED FROM THIS APERTURE." is placed
near any opening through which a bar code reading beam emits. Avoid exposure to laser light
emitted.
Sharp Objects Caution
A label reading, "CAUTION. SHARP OBJECTS - REFER SERVICING AND MAINTENANCE TO QUALIFIED
SERVICE PERSONNEL." is found on top of the optional cap piercing hardware which is located
underneath the removable cover of the cap piercing tower.
CAUTION
SHARP OBJECTS - REFER
SERVICING AND MAINTENANCE TO
QUALIFIED SERVICE PERSONNEL.
A012936L.EPS
A13914AF
xix
Safety Notice
Hardware Symbols and Labels
ISE Cover Caution
A label reading, "THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION." is
placed on top of the ISE module frame under the ISE cover to indicate that the ISE cover should
remain in place during system operation.
THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION.
471830-AA
A012937L.EPS
Moving Parts Caution
A label reading, "CAUTION PARTS MOVE AUTOMATICALLY" is placed inside the offload track, on the
left side of the back wall.
CAUTION
PARTS MOVE
AUTOMATICALLY
A015047L.EPS
MC Door Caution
A label reading, "THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION." is found on
the top edge of the left hand (MC reagent) door and indicates that the door should remain closed
during system operation.
THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION.
471831-AA
A012938L.EPS
xx
A13914AF
Safety Notice
Hardware Symbols and Labels
Read Manual Caution
A label reading, "CAUTION - READ MANUAL BEFORE OPERATING." is found on the hydropneumatics
behind the center door and recommends the operator read the manuals before operating the
system.
CAUTION - READ MANUAL
BEFORE OPERATING
ATTENTION - CONSULTER LA NOTICE
AVANT DE FAIRE FONCTIONNER.
270-455774-A
A012939L.EPS
Rack Loading Label
This label is found to the right of the Run and Priority Load buttons and indicates the correct
position of a rack for placement into the autoloader.
Laser Certification Label
This label is found on the back, bottom edge of the system. It provides information about the laser.
PRODUCT COMPLIES WITH
21 CFR CHAPTER I, SUBCHAPTER J
MANUFACTURED
DECEMBER 2004
LABEL P/N 448229 AB
BECKMAN COULTER, INC
S
MADE IN U.S.A. MARCA REG
A011540L.EPS
A13914AF
xxi
Safety Notice
Hardware Symbols and Labels
Ethernet/Serial Port Label
This label is found on the right side of the system and identifies connections for the Ethernet and
serial ports.
SERIAL PORT
ETHERNET
A012942L.EPS
Fluid Interface Label
This label is found on the center, back, bottom edge of the system.
It identifies inlet and outlet ports on the system.
136
WASTE B
SENSOR
D. I. WATER INLET
MAX. PRESS. 100 PSI (689 kPa)
128
WASTE B
OUTLET
137
WASTE OUTLET
D.I. FIBER
A012943L.EPS
xxii
A13914AF
Safety Notice
Hardware Symbols and Labels
Recycling Label
This symbol is required in accordance with the Waste Electrical and Electronic Equipment (WEEE)
Directive of the European Union. The presence of this marking on the product indicates:
1. the device was put on the European Market after August 13, 2005 and
2. the device is not to be disposed of via the municipal waste collection system of any member
state of the European Union.
A016608L.EPS
It is very important that customers understand and follow all laws regarding the proper
decontamination and safe disposal of electrical equipment. For Beckman Coulter products that have
this label please contact your dealer or local Beckman Coulter office for details on the take back
program that will facilitate the proper collection, treatment, recovery, recycling and safe disposal
of device.
A13914AF
xxiii
Safety Notice
Hardware Symbols and Labels
Restriction of Hazardous Substances (RoHS) Labels
These labels and materials declaration table (the Table of Hazardous Susbtance's Name and
Concentration) are to meet People's Republic of China Electronic Industry Standard SJ/T11364-2006
"Marking for Control of Pollution Caused by Electronic Information Products" requirements
RoHS Caution Label
This logo indicates that this electronic information product contains certain toxic or hazardous
elements, and can be used safely during its environmental protection use period. The number in the
middle of the logo indicates the environmental protection use period for the product. The outer
circle indicates that the product can be recycled. The logo also signifies that the product should be
recycled immediately after its environmental protection use period has expired. The date on the
label indicates the date of manufacture.
RoHS Environmental Label
This logo indicates that the product does not contain any toxic or hazardous substances or
elements. The "e" stands for electrical, electronic and environmental electronic information
products. This logo indicates that this electronic information product does not contain any toxic or
hazardous substances or elements, and is green and is environmental. The outer circle indicates
that the product can be recycled. The logo also signifies that the product can be recycled after being
discarded, and should not be casually discarded.
xxiv
A13914AF
Safety Notice
Documentation Symbols
Documentation Symbols
Read all product manuals and consult with Beckman Coulter-trained personnel before attempting
to operate instrument. Do not attempt to perform any procedure before carefully reading all
instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as
to how to proceed in any situation, contact your Beckman Coulter representative.
Alerts for Warning, Caution, Important, and Note
WARNING
WARNING indicates a potentially hazardous situation which, if not avoided, could
result in death or serious injury. May be used to indicate the possibility of
erroneous data that could result in an incorrect diagnosis (does not apply to all
products).
CAUTION
CAUTION indicates a potentially hazardous situation, which, if not avoided, may
result in minor or moderate injury. It may also be used to alert against unsafe
practices. May be used to indicate the possibility of erroneous data that could
result in an incorrect diagnosis (does not apply to all products).
IMPORTANT IMPORTANT is used for comments that add value to the step or procedure being performed.
Following the advice in the Important Notice adds benefit to the performance of a piece of equipment or
to a process.
NOTE NOTE is used to call attention to notable information that should be followed during installation, use,
or servicing of this equipment.
A13914AF
xxv
Safety Notice
Documentation Symbols
xxvi
A13914AF
Contents
Revision History, iii
Safety Notice, v
Introduction, xxxiii
CHAPTER 1:
System Description, 1-1
System Description, 1-1
Operational Conditions, 1-1
System Components, 1-5
Sample Handling System, 1-6
Modular Chemistry (MC) System, 1-12
Cartridge Chemistry (CC) Reagent Handling System, 1-17
Cuvette Reaction System, 1-21
Hydropneumatic System, 1-24
Operation and Control Components, 1-26
Main Screen and Program Structure, 1-27
Theory of Operation, 1-43
Cartridge Chemistry: Calibration Theory, 1-43
Modular Chemistry: Calibration Theory, 1-53
Cartridge Chemistry: Principles of Measurement, 1-54
CHAPTER 2:
Preparing Samples for Analysis, 2-1
Routine Operation Overview, 2-1
Preparing Samples for Analysis, 2-2
How to Use Reserved Racks, 2-7
xxvii
Contents
CHAPTER 3:
System Setup Options, 3-1
Overview, 3-1
Password Setup, 3-2
Auto Serum Index/ORDAC, 3-4
Configuring the Chemistry Menu, 3-5
Setting the Default Sample Type, 3-13
Date/Time Setup, 3-13
Demographics Setup, 3-14
Patient Results – Immediate Reporting Setup, 3-14
Panels, 3-15
Replicates, 3-16
Report Setup, 3-16
Reportable Ranges Setup, 3-17
Reference/Critical Ranges Setup, 3-19
Sample Comments Setup, 3-19
Special Calculations Definition, 3-20
Timed Urine and Creatinine Clearance Results, 3-23
Version Information, 3-23
Units/Precision Setup, 3-24
User Defined Chemistries Setup, 3-24
Bar Code Setup, 3-25
Maximum Sample Program Age, 3-26
Reserved Racks/Obstruct Detect, 3-26
Disable Service Monitor, 3-27
Host Communications, 3-28
Language/Keyboard Setup, 3-29
Printer Setup, 3-30
Service Setup, 3-30
System Configuration, 3-31
Version Upgrade, 3-31
Status Alarm/Annunciator, 3-32
Chemistry Update, 3-32
Auto Generation of Control, 3-33
xxviii
Contents
CHAPTER 4:
Reagent Load/Calibration, 4-1
Reagent Load, 4-1
System Calibration, 4-12
Load a Calibrator Diskette, 4-12
Calibrator Assignment, 4-13
Calibration Status, 4-14
Reagent and Calibration Status Warnings, 4-15
Request a Calibration, 4-16
Calibration Failure Messages, 4-18
Within-Lot Calibration, 4-19
Enzyme Validator, 4-23
Calibration Override, 4-24
Chemistry Bypass, 4-25
Extend Calibration Time, 4-26
Calibration Acceptance Limits, 4-27
Calibrator Set Point Modifications, 4-28
Slope Offset Adjustment, 4-29
Reprint Calibration Reports, 4-31
CHAPTER 5:
Quality Control, 5-1
Quality Control, 5-1
Define a Control, 5-4
Control ID Assignments, 5-7
Run Control Samples, 5-7
Edit a Control Definition, 5-9
Review a Control Definition, 5-12
Delete a Control, 5-12
Print QC Ranges, 5-13
QC File List, 5-14
QC Summary, 5-15
QC Chart (Levey-Jennings), 5-16
QC Log, 5-18
Quality Assurance Program (QAP) “Copy To Disk” Feature, 5-21
Archive QC, 5-23
xxix
Contents
Review Archived Data, 5-24
CHAPTER 6:
Sample Programming and Processing, 6-1
Overview, 6-1
Prior to Programming, 6-2
Identify Samples, 6-4
Sample Programming and Processing, 6-6
Additional Programming Information, 6-10
Clear Samples, 6-12
CHAPTER 7:
Results Recall, 7-1
Overview, 7-1
Recall Results by Sample ID, 7-2
Recall Results by Rack and Position, 7-3
Recall Results by Patient ID, 7-4
Recall Results by Run Date/Time, 7-4
Display Recalled Results, 7-5
Edit Critical Rerun Result, 7-6
Print Recalled Results, 7-7
Send Results to the Host, 7-8
Absorbance Versus Time, 7-8
Statistical Summary Report, 7-10
CHAPTER 8:
User Defined Reagents, 8-1
Overview, 8-1
Requirements and Precautions, 8-1
User-Defined Reagent Setup, 8-3
Chemistry Parameters, 8-4
Processing Parameters, 8-8
Error Detection Limits, 8-13
Wavelength Selection, 8-15
Determination of Extinction Coefficients, 8-16
Exit Check Criteria, 8-17
User Defined Reagent Removal, 8-19
Expanded User Defined Chemistry Feature, 8-20
xxx
Contents
CHAPTER 9:
Maintenance, 9-1
Overview, 9-1
Electronic Maintenance Log, 9-4
Twice Weekly Maintenance, 9-7
Weekly Maintenance, 9-9
Check Chloride Calibration Span, 9-17
Monthly Maintenance, 9-17
Two-Month Maintenance, 9-36
Three-Month Maintenance, 9-43
Four-Month Maintenance, 9-48
Six-Month Maintenance, 9-52
As-Needed/As-Required Maintenance, 9-64
CHAPTER 10:
System Status and Commands, 10-1
Overview, 10-1
System Status, 10-1
Status-Cycle Count, 10-2
Temperatures, 10-3
Show Temperature Status, 10-3
Power Subsystems, 10-4
Hydropneumatics Subsystem, 10-4
ICS/Smart Modules, 10-5
Cuvette Water Blank Status, 10-6
CTS Tracking, 10-7
Instrument Commands, 10-8
Home, 10-8
Pause, 10-9
Stop Print, 10-11
Shutdown, 10-12
System Power On/Boot, 10-14
Pause/Resume Waste B, 10-15
Enable/Disable Modules, 10-16
Unload All, 10-18
xxxi
Contents
CHAPTER 11:
Utilities, 11-1
Overview, 11-1
Prime, 11-1
Maintenance, 11-6
Event Log, 11-6
Alignment/Diagnostics/PVTs, 11-12
Metering, 11-12
Modem, 11-12
Backup/Restore, 11-13
Touch Screen Calibration, 11-16
CHAPTER 12:
Troubleshooting Calibration and Result Errors, 12-1
Calibration Errors, 12-1
MC Calibration, 12-2
Linear Calibration, 12-7
Non-Linear and Multipoint Calibrations, 12-10
Troubleshooting Result Errors, 12-13
Error Codes and Definitions, 12-14
Error Code – Definitions, 12-17
Common Error Messages and Corrective Actions, 12-1
Glossary, Glossary-1
Index, Index-1
Related Documents
xxxii
Introduction
Intended Use
The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical
chemistry analyzers designed for the in vitro determination of a variety of general chemistries,
therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or
cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Scope of This Manual
This manual covers basic operating instructions and maintenance guidelines for UniCel DxC 600/
800 Systems. Detailed operation, maintenance, and troubleshooting instructions are not included
in this manual. In addition, medical and diagnostic interpretation, or the clinical significance of
chemistries or assays are not discussed. Refer to the reference materials in the Related Documents
section for detailed information.
Manual Conventions
This manual uses the following printed and visual cues to guide the user in responding to printed
directions.
Table 1 Conventions Used in this Manual
Convention
Combination Keys
Description
Keyboard characters that when pressed, in conjunction with the
Control or Alt key, invoke a command. They are enclosed in ( ) with a
+ sign between each key.
Examples:
(Alt) + (X) or (Ctrl) + (Alt) + (Delete)
Command buttons
(buttons with names on
a screen)
A13914AF
Buttons with names are bold and use a SansSerif font.
Examples:
Select OK.
Select Cancel.
xxxiii
Introduction
Manual Conventions
Table 1 Conventions Used in this Manual (Continued)
Convention
Function buttons
Description
Function buttons are bold and use a SansSerif font.
Example:
Select Print F10.
Icon buttons
Icon buttons are bold and use a SansSerif font.
Example:
Select Samples from the menu bar.
Instrument buttons
Buttons on an instrument are bold and use a SansSerif font. They may
be all upper case or initial caps.
Example:
Press the STOP button.
Keyboard keys
Keyboard keys are enclosed in ( ) .
Examples:
(X) , (→) , (Tab) , (Enter)
Pull-down menus
Use the pull-down menu to see a list of options you can select.
Example:
Select the Calibrator Name pull-down menu at the top of the Assign
Barcode/Rack dialog box to view the list of calibrators.
Text field
Names in the text fields are bold and use a SansSerif font, followed by
the word "field".
Example:
Type the Patient ID in the Patient ID field.
xxxiv
A13914AF
Introduction
How to Use this Manual
How to Use this Manual
Manual Format
Information in this manual is presented in modular units. Each unit of information is described by
a brief title in the left margin.
Many units consist of a numbered list which presents a procedure, process, or description.
Procedure Lists
Procedure lists are the most common type of lists in this manual. Each step of a procedure is listed
by number with the corresponding action that is to be performed.
Occasionally, a decision must be made at a step within a procedure. An indented decision list is then
presented which describes the variable conditions in the first bullet and the appropriate action for
each condition in the subordinate bullets.
Example of a Procedure
The following is an example of a procedure that contains a decision list.
1
Select Rerun F6.
• To enter individual Sample IDs,
— Type the Sample IDs for rerun in the Sample IDs field.
• To enter a range of Sample IDs,
— Type the Sample ID at the beginning of the range in the Range field.
2
Select a button from the bottom of the dialog box.
Read the decision list as a complete sentence, using the first bullet to introduce the condition and the
second level bullet to introduce the action.
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xxxv
Introduction
How to Use this Manual
xxxvi
A13914AF
CHAPTER 1
System Description
System Description
Introduction
This chapter describes the system components, operational theories, principles of measurement,
programming structure, and operator controls. Detailed information is located in the UniCel DxC
Synchron Clinical Systems Reference Manual.
Operational Conditions
Shipping Damage
Each DxC System is carefully examined and checked by Beckman Coulter, Inc. before it is shipped.
When you receive your new DxC System, visually inspect the shipping container for damage. If
there is damage, notify the Beckman Coulter Service representative before he or she arrives at your
facility to install your system.
Installation
Table 1.1 Installation Requirements
Item
A13914AF
Requirement
Installed by
The DxC system is installed completely by Beckman Coulter
Installation Category
II
1-1
System Description
Operational Conditions
Clearances
Table 1.2 System Clearances
Area Affected
Clearance Needed
Left Side
Minimum of 6 inches (15.2 cm) clearance or 12 inches (30.5 cm) to access smart
modules.
Right Side
Minimum of 18 inches (45.7 cm) clearance when monitor on swing arm is in use.
Back
Zero inches. The venting design of the system allows for "0 inch" clearance at the
back.
Top
Minimum of 22 inches (55.9 cm) from highest point of system.
Front
Minimum of 25 inches (63.5 cm) to open doors.
Sunlight and Drafts
Do not place the system in direct sunlight or in drafts. Both of these conditions may affect the
temperature control of the system.
Drain
The system should be located near a sink or floor drain to accommodate the waste effluent at a
minimum rate of 6 liters/hour (16 liters/hour continuous flow).
The drain must not be placed any higher than 36 inches (91.4 cm) above the floor.
Power Requirements
Table 1.3 Power Requirements – DxC 600 or 800 Analytic Unit
Item
1-2
Requirement
Operating range
200–240 VAC ± 10% (180–264 VAC)
14 A at low line, exclusive of power on surge
Frequency
50/60 Hz
BTU generated
10,500 BTU/hour
Power connector
20 A current rating, NEMA L6-20R twistlock in-line connector
A13914AF
System Description
Operational Conditions
Table 1.4 Power Requirements – DxC Console (PC System and Monitor)
Item
Requirement
Operating range
100–120 VAC ± 10% (90–132 VAC); 4A
OR
200–240 VAC ± 10% (180–264 VAC); 2A
Frequency
50/60 Hz
BTU generated
1,500 BTU/hour
Power connector
15 A current rating, IEC 320 standard connector
Table 1.5 Power Requirements – Okidata B4350 LED Printer
Item
Requirement
Operating range
110–127 VAC ± 10% (99–140 VAC); 3A
OR
220–240 VAC ± 10% (198–264 VAC); 1.6A
Frequency
50/60 Hz
BTU generated
1228 BTU/hour (printing); 34 BTU/hour (standby power save)
Power connector
15 A current rating, IEC 320 standard connector
Notes on the System Power
The system can operate from any standard 3-wire electrical outlet and is wired as shipped from the
factory to operate on 220 VAC, 50/60 Hz.
IMPORTANT Line Voltage from the electrical outlet should be free of spikes, fluctuations, and dropouts for
protection of the electronic circuitry.
CAUTION
Only operate the system from a 3-wire power source. DO NOT use a 2-prong
adapter or a 2-wire AC power source.
Environmental Conditions
Table 1.6 Temperature, Humidity and Elevation
Item
A13914AF
Specification
Environment
Indoor use only
Ambient temperature
+18°C to +32°C
Warm-up time
30 minutes (time to reach operating temperature)
Relative humidity
20–85% relative, non-condensing
Elevation
Up to 4,200 ft (1280 m)
1-3
1
System Description
Operational Conditions
Water Requirements
Table 1.7 Water Requirements
Item
Specification
Flow Rate
0.6 L/min peak flow rate, 16 L/hr minimum continuous flow rate
Temperature
+15°C to +25°C
Water pressure
Deionized water entering the system must be 30–90 psi.
Table 1.8 Water Quality Requirements
CLSI (CLRW) 4TH Ed. C03 --A4
Formerly NCCLS (Type I & II)
Notes
Replaces Type I & II.
4th Ed. C03 --A4
CLSI
Beckman Coulter Requirements
CLRW
Organic Impurities
Not Applicable
Total Organic Carbon (TOC)
500 ng/g TOC (Total Organic
Carbon) parts per billion (ppb)
Microbiological Impurities
10 CFU/mL
10 CFU/mL
10 MΩ.Cm
1.0 MΩ.Cm
Particulate & Colloid Content
Purification process
requirement only: water
filtration using 0.22 μm pore
size to remove microorganisms
and particulates
Purification process
requirement only: water
filtration using 0.22 μm pore
size to remove microorganisms
and particulates
pH
Not Applicable
Not Appiicable
Maximum silicate (mg/mL) SiO2
Not Applicable
Not Applicable
Maximum microbial content colony
forming unit (CFU/mL)
Ionic Impurities
Minimum resistivity,
megohm.centimeter
(MΩ.Cm@25C)
Other System Specifications for IEC-1010 Compliance
Table 1.9 IEC-1010 Specifications
Item
1-4
Specification
Pollution Degree
2
EN55011
Meets Class A
Maximum Sound Pressure
≤65 dBA average over 8 hours with covers down at 1 meter away from
the instrument at +25°C
A13914AF
System Description
System Components
Table 1.9 IEC-1010 Specifications
Item
Maximum Leakage Current
Specification
DxC 600: 222 μA at 240V, 50Hz
DxC 800: 240 μA at 240V, 50Hz
System Components
DxC Systems
A UniCel DxC System can be divided into the following components:
• Sample Handling Components
• Modular Chemistry System
• Cartridge Chemistry Reagent Handling System
• Hydropneumatic System
• Operation and Control Components
A Closed Tube Sampling System has optional components listed below:
• Large Particle Immuno Assay Module (LPIA)*
• Closed Tube Sampling (CTS)
* Equivalent to Near Infrared Particle Immuno Assay (NIPIA).
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1-5
1
System Description
Sample Handling System
Figure 1.1 UniCel DxC 600/800 Analyzer (600 shown)
1
2
3
4
5
A011869P.EPS
1. Modular Chemistry (MC) Section
2. Cartridge Chemistry (CC) Portion
3. Autoloader
4. Dual Reagent Carousel
5. Operator Console
Sample Handling System
Introduction
The Sample Handling system is composed of the following components:
• Sample racks
• Autoloader/Offload track
• Shuttle
• Bar code reader
• Cap piercer assembly (optional)
• Sample Carousel
• Sample probe/mixer assemblies
The sample handling module is used to load samples onto the system, provide samples for analysis,
and provide temporary storage of completed samples. A detailed description of each component is
presented in the following paragraphs.
1-6
A13914AF
System Description
Sample Handling System
Sample Racks
A sample rack is a high-strength, plastic, centrifugable holder designed to house up to four samples.
There are four sizes of racks with each size capable of holding one length/width combination of
primary sample tubes in addition to accepting sample cups. Refer to Figure 1.2.
Sample racks accept the following tube and cup sizes:
IMPORTANT Adapters are provided to adapt various sized sample tubes (secondary tubes) to the short
racks. These adaptors must only be used in racks designated as reserved. The reserved rack feature is
described in CHAPTER 3, System Setup Options.
Table 1.10 Sample Racks
Rack
13 × 75
Accepts These Cups and Tubes
12 × 75 mm tubes
13 × 75 mm tubes
0.5 mL cups
2.0 mL cups
16 × 75
16 × 75 mm tubes
13 × 100
13 × 100 mm tubes
0.5 mL cups
2.0 mL cups
Capillary collection tubes (use with the capillary tube adapter)
Beckman Coulter Microtubes
16 × 100
16 × 100 mm tubes
16 × 92 mm tubes
16.5 × 100 mm tubes
Beckman Coulter 0.5 mL Cup Insert (PN 467406)
A13914AF
1-7
1
System Description
Sample Handling System
Rack ID Labels
Sheets of bar-coded rack ID labels are supplied with the system. They can be applied as shown in
Figure 1.2.
Figure 1.2 Rack
1. Numeric Rack ID Number
2. Rack Size Label
3. Bar Coded Rack ID Label
1-8
A13914AF
System Description
Sample Handling System
Autoloader/Offload Track
When viewed from the front of the system, the autoloader is on the left and holds up to 25 sample
racks in preparation for presentation to the DxC 800 system. The DxC 600 system has room to load
a maximum of 14 racks. Refer to Figure 1.3.
There is also space for 25 sample racks in the offload track as they are removed from the Sample
Carousel upon completion.
IMPORTANT When loading racks onto the autoloader, make sure that they are placed firmly down into the
autoloader.
Figure 1.3 Sample Loading Area
1
2
3
4
5
6
7
A011870P.EPS
1.
2.
3.
4.
Pushers
Run Button
Priority Load Button
Autoloader
5. Shuttle
6. Offload Track
7. Stop Button
Priority Load Position
Between the Autoloader and the Sample Gate is the Priority Load position. This position is used in
conjunction with the PRIORITY LOAD button when a rack is to be loaded onto the Sample Carousel
into a reserved priority position so that it can be run in a higher priority than other racks on the
Autoloader. Refer to Figure 1.3.
A13914AF
1-9
1
System Description
Sample Handling System
Priority Load Button
Typically, rack placement and removal is under microprocessor control. The operator may use the
reserved positions in the sample carousel by pressing the PRIORITY LOAD button and placing the
priority rack in the space provided by the system. The rack loads into one of the reserved positions
on the Sample Carousel.
PRIORITY LOAD only prioritizes the loading of the rack. It does not alter the sample priority (STAT
or routine) previously designated in Sample Programming.
Pushers
Pushers collect and move to the Sample Gate any racks loaded onto the system. They are activated
when the RUN button is pressed. Refer to Figure 1.3.
Sample Gate
The Sample Gate is the mechanism that moves racks from the load tray to the shuttle during the
load process. It also moves samples from the shuttle to the unload track during the unload process.
Shuttle
The Shuttle moves the rack from the gate area onto the Sample Carousel. Refer to Figure 1.3.
Bar Code Reader (Sample)
CAUTION
Do not tamper with or remove the housing of the Sample Bar Code Reader.
The Bar Code Reader is a Class II fixed-beam laser scanner. It is used to read the rack bar code, the
sample bar code (if present), and the background bar codes as the rack travels past. The rack bar
code and sample bar code (if present) are used to identify the sample and link it to the appropriate
sample programming.
There are two background bar codes that are used to determine whether a rack position is empty or
occupied, and if occupied, whether the sample is in a cup or tube.
Refer to Documentation Symbols in the Safety Notice section, for a description of the CAUTION
labels for the bar code reader.
1-10
A13914AF
System Description
Sample Handling System
1-Blade Thick CTS (Closed Tube Sampling) or 1-Blade Narrow CTS Cap Piercer
Assembly (optional)
CAUTION
This Cap Piercer contains a razor sharp blade assembly.
CAUTION
To avoid damage to the blade, do NOT use this Cap Piercer assembly with
foil-capped tubes.
This optional 1-Blade Thick CTS or 1-Blade Narrow CTS Cap Piercer assembly pierces capped tubes
allowing the sample probe access to the sample without the need for cap removal. Tubes with caps
must be loaded in racks that have had the size correctly defined and that are not Reserved (Reserved
Racks = No CTS). Both open and closed tubes can be in the same sample tube rack.
Table 1.11 Tubes Validated for Closed Tube Sampling
Cap Piercer Configuration
1-Blade Thick CTS
1-Blade Narrow CTS
Tube Type
Tube Size
Becton Dickinson VACUTAINER with
HEMOGARD
13 × 75 mm
13 × 100 mm
16 × 100 mm
Greiner VACUETTE
13 × 75 mm
13 × 100 mm
Sarstedt S-Monovette
75 × 15 mma
92 × 15 mm
a. This tube requires a special 5.5 mL rack (PN A18642).
Refer to Documentation Symbols in the Safety Notice section, for a description of the CAUTION
labels for the Cap Piercer.
A13914AF
1-11
1
System Description
Modular Chemistry (MC) System
Sample Carousel
The ten-rack position Sample Carousel is a motor-driven turntable. Refer to Figure 1.4. Under
normal operation, eight of the Sample Carousel positions are available for routine processing and
two positions are reserved for priority racks.
Figure 1.4 Sample Carousel Area
1
2
3
4
A015903P.EPS
1. Liquid Level Sense Assembly
2. Sample Probe (MC)
3. Collar Wash
4. Sample Carousel
Modular Chemistry (MC) System
Introduction
The Modular Chemistry system consists of the following major assemblies:
• Reagent storage area
• Ratio pump
• Sample probe
• Electrolyte injection cup (EIC)
• Flow cell assembly
• Chemistry reaction modules
A detailed description of each component is presented in the following paragraphs.
1-12
A13914AF
System Description
Modular Chemistry (MC) System
Reagent Storage Area
The reagent containers used to supply the modular chemistries are located behind the left front
door of the system. The only exception is the CO2 alkaline buffer which is located on the ISE module.
Figure 1.5 Modular Chemistry Reagent Storage Area
1. Bar Code Reader (hand held)
2. Reagent Storage Area
Reagent Bar Code Reader (Modular)
Behind the left side door of the system there is a hand-held bar code reader. Refer to Figure 1.5.
When this reader is held up to the label of one of the modular reagents and the trigger is pressed,
the identity of the reagent, the lot number and reagent volume are automatically entered into the
reagent load screen.
A13914AF
1-13
1
System Description
Modular Chemistry (MC) System
Ratio Pump
The Ratio Pump is a motor-driven, multicylinder, positive-displacement pump used to deliver the
necessary reagents to the ISE flow cell. Refer to Figure 1.6. It consists of a three-step piston housed
in three, stacked, independent cylinders.
Figure 1.6 DxC 800 Ratio Pump
1
2
3
4
5
6
A015904P.EPS
1. Solenoid Valve (example)
2. Cylinder 1
3. Cylinder 2
1-14
4. Cylinder 3
5. Outlet Line (example)
6. Inlet Line (example)
A13914AF
System Description
Modular Chemistry (MC) System
Electrolyte Injection Cup (EIC)
The EIC mixes the sample and buffer prior to delivery of the sample (now diluted) to the flow cell.
Figure 1.7 Electrolyte Injection Cup
1. Waste Outlet
2. Flow Cell Outlet
3. Buffer Inlet
A13914AF
4. Reference Inlet
5. DI H2O Inlet
1-15
1
System Description
Modular Chemistry (MC) System
Flow Cell Assembly
The flow cell assembly houses the seven electrodes that perform the analysis of sodium, potassium,
chloride, carbon dioxide, and calcium.
Figure 1.8 Flow Cell
1.
2.
3.
4.
5.
1-16
Inlet Port
CL Electrode
K Electrode
CO2 Reference Electrode
CO2 Electrode
6. Exit Port for Waste (large tube)
7. Exit Port for Internal reference
8. Na Reference Electrode
9. Na Electrode
10. Ca Electrode
A13914AF
System Description
Cartridge Chemistry (CC) Reagent Handling System
Chemistry Reaction Modules (Basic Components)
Each of the six Chemistry Reaction Modules have similarities in their design. These common
elements are described below. Refer to Figure 1.9. Unique design elements of the modules are
described under the specific module headings later in this section.
Figure 1.9 Basic Components of Modules (Ex: Albumin)
2
3
4
1
5
A015905P.EPS
1. Circuit Board (behind protective shield)
2. Reaction Cup
3. Reaction Cup Housing
4. Mixer Motor Assembly
5. Reagent Pump Assembly
Cartridge Chemistry (CC) Reagent Handling System
Introduction
The Cartridge Chemistry Reagent Handling system is composed of the following components:
• Reagent cartridges
• Reagent carousel
• Reagent probe assembly
• Reagent mixer assembly
• Mixer wash cup
The Reagent Handling system is used to transfer reagent from the individual cartridges to the
reaction cuvettes for processing and analysis of the requested chemistry tests.
A13914AF
1-17
1
System Description
Cartridge Chemistry (CC) Reagent Handling System
Reagent Cartridges
Reagent cartridges are single use, recyclable plastic containers that house the individual liquid
reagent components necessary to perform a chemistry test. The reagent carousel is capable of
storing 59 cartridges on board.
Figure 1.10 CC Reagent Cartridge
1. A Compartment
2. B Compartment
3. C Compartment
1-18
A13914AF
System Description
Cartridge Chemistry (CC) Reagent Handling System
Reagent Carousel and Reagent Bar Code Readers
The Reagent Carousel Compartment provides an on-instrument storage area for the individual
reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time. Refer
to Figure 1.11.
The storage compartment is refrigerated and fan-cooled to maintain a temperature of +5°C (±3°C).
The Bar Code Reader, (refer to Figure 1.11), situated near the front of the Cartridge Chemistry
reagent access door, scans each label during the loading of reagent cartridges. Only the reader for
the selected carousel is active. An audible signal acknowledges successful reading of the label.
Figure 1.11 CC Dual Carousels with Two Bar Code Readers
1
2
3
4
A007408P.EPS
1. Top Positions 31–59
2. Top Bar Code Reader
A13914AF
3. Bottom Positions 1–30
4. Bottom Bar Code Reader
1-19
1
System Description
Cartridge Chemistry (CC) Reagent Handling System
Reagent Probe Assembly
The Reagent Probe assembly consists of a mechanical structure that supports two moveable cranes.
Attached to each crane is a pickup probe. Refer to Figure 1.12.
Figure 1.12 CC Reagent Probe Area
1
2
3
4
A015908P.EPS
1. Reagent Mixer
2. CC Reagent Probe A
3. CC Reagent Probe B
4. Collar Wash
Reagent Mixer Assembly
This assembly consists of a mechanical structure that supports a single, moveable crane. Attached
to the crane is a high-speed mixer. Refer to Figure 1.12.
Reagent Mixer Wash Cup
The Mixer Wash Cup sprays the mixer with diluted wash solution while the mixer moves up and
down in the cup.
1-20
A13914AF
System Description
Cuvette Reaction System
Cuvette Reaction System
Introduction
The Cuvette Reaction system consists of the following components:
• Reaction carousel assembly
• Photometer assembly
• LPIA (Large Particle Immuno Assay) or NIPIA (Near-Infrared Particle Immuno Assay) module
(optional)
• Cuvette wash station
The Cuvette Reaction system involves the process of obtaining absorbance readings from each
cuvette during the analysis cycle.
Following the completion of each chemistry test, the cuvettes are processed through a wash station
in preparation for the next chemistry.
A description of each component is presented in the following paragraphs.
Reaction Carousel
The reaction carousel assembly, (refer to Figure 1.13), supports a total of 125 cuvettes. Each cuvette
is glass with a 0.5 cm path length and is approximately 30 mm high. The cuvettes are non-disposable
and have an indefinite life-span on the instrument. Cuvettes only need replacement if they are
damaged. (They remain under warranty for two years.)
A13914AF
1-21
1
System Description
Cuvette Reaction System
Figure 1.13 Reaction Carousel Area (Typical – Cover Removed)
2
3
1
A015909P.EPS
1. LPIA Module (optional)
2. Reaction Carousel
3. Photometer
Photometer Assembly
Attached to the reaction carousel support frame is the Photometer assembly. This consists of a
xenon pulse lamp, a discrete 10-position silicon-diode detector array, a monochromator housing
unit, and associated electronic circuitry. Refer to Figure 1.13.
As each cuvette passes through this optics station during a spin cycle, the xenon lamp is flashed and
the resulting light beam travels through the opposing sides of the square cuvette.
LPIA (Large Particle Immuno Assay)
The optional LPIA module uses a photometric detection system for large particle immuno assays.
This assembly is attached to the reaction carousel support frame to the left of the photometer
assembly, near the sample carousel. Refer to Figure 1.13. It has two printed circuit boards, an LED
(light-emitting diode) and a photodetector. Communication with the system software is through
fiber optic cables.
1-22
A13914AF
System Description
Cuvette Reaction System
Cuvette Wash Station
The Cuvette Wash Station, (refer to Figure 1.14), consists of four coaxial probes, an elevator
assembly, and the associated tubing.
A motor controls the vertical motion required by the elevator to raise and lower the probes during
the wash stage.
Figure 1.14 Cuvette Wash Station
1. Probe #1
2. Probe #2
3. Probe #3
A13914AF
4. Probe #4
5. Wash Station
1-23
1
System Description
Hydropneumatic System
Hydropneumatic System
Introduction
The main components of the Hydropneumatic System are mounted on a slide-out drawer that
allows for easier operator access. Refer to Figure 1.15 and Figure 1.16. When fully extended, the
drawer locks open. To close, lift up on the metal tabs, located on each side of the bottom runner of
the hydropneumatic unit, and push the drawer inward.
Figure 1.15 DxC 800 Hydropneumatics (right side)
6
5
4
3
2
1
A016497P.EPS
1. Wash Concentrate Solution
2. No Foam Reagent
3. DI Water Canister
1-24
4. Wash Solution Canister
5. Wash Concentrate Reservoir
6. Auto-Gloss
A13914AF
System Description
Hydropneumatic System
Function
The function of the hydropneumatic system is to provide the following media to the different
functional areas of the instrument:
• Vacuum
• Compressed air
• Diluted wash solution
• Deionized water
Figure 1.16 DxC 800 Hydropneumatics (left side)
7
6
5
4
3
1
2
A015911P.EPS
1.
2.
3.
4.
A13914AF
Waste B Exit Sump
Waste Exit Sump
DI Water Inlet On/Off
Waste Sump
5. Waste B Sump
6. DI Water Reservoir
7. Vacuum Accumulator
1-25
1
System Description
Operation and Control Components
Operation and Control Components
Operator Controls
The operator interfaces with various control devices such as the keyboard, monitor and pushbutton controls during a routine run. Basic operating functions are controlled and reviewed from
the monitor. Calibration functions are also controlled from the monitor. Information is selected and
entered into the system through touch screen monitors, from a mouse, and/or at a keyboard.
Push-button controls (refer to Figure 1.3) are used to start the process, to prioritize a sample run,
or to stop the process under certain conditions as described in Table 1.12.
Table 1.12 DxC Push-Button Controls
Push-Button
Control Type
Primary Function
Run
To start the test process.
Priority
To prioritize the loading of a rack by creating a space in front of the autoloader for
loading the next rack into a priority position on the sample carousel. It does not alter
the sample priority (STAT or routine) previously defined in sample programming.
Stop
To stop the process. The stop button should be used only under the following
conditions:
• To stop instrument motions
• To conduct a maintenance/repair activity
• To home and realign mechanical components without rebooting
1-26
A13914AF
System Description
Main Screen and Program Structure
Main Screen and Program Structure
Main Screen
DxC System operating and programming functions are initiated from the Main screen at the DxC
analyzer (refer to Figure 1.17). In addition, the screen provides status information to help
determine the present state of the system.
Figure 1.17 UniCel DxC 800 Main Screen
1
2
3
4
5
6
7
E011950S.EPS
1.
2.
3.
4.
A13914AF
CTS Indicator
Host Indicator
System Status Indicator
Menu Bar
5. Sample Status Icons
6. Rack Status Area
7. Function Bar
1-27
1
System Description
Main Screen and Program Structure
Status Functions
The following Table depicts the status information available from the operator screens of the DxC
analyzer.
Table 1.13 Main Screen Status Functions
Status Indicator
CTS
Status Description
This indicator (1) in Figure 1.17, appears in the blue bar at the top left side of the
Operator screens when the Closed Tube Sampling (CTS) option is installed. When
"CTS" appears, Closed Tube Sampling is enabled. When CTS appears within the
international "No" symbol (
), the feature has been installed, but it is not
enabled. When the indicator is absent, the CTS option is not installed. Enabling and
disabling Closed Tube Sampling is accomplished using the Setup procedures
described in the Reserved Racks/Obstruct Detect topic of CHAPTER 3, System Setup
Options.
IMPORTANT CTS is an optional feature of the system, which allows the system to
pierce primary sample tubes. The operator is only offered the enable/disable
CTS option if a CTS assembly is installed, otherwise that selection is grayed out
on the Setup screen. The default for CTS sampling is "OFF."
Host
This indicator (2) in Figure 1.17, appears on the blue bar at the top right side of the
Operator screens. The indicator to the right of the label shows communication
activity between the instrument and the host computer. A blue bar indicates that
the host is sending information. A green bar indicates that the host is receiving
information.
Printing
The indicator appears at the middle of the operator screens. When the indicator
appears, you must reboot the DxC system to restart printing.
System Status
1-28
This indicator (3) appears on the left side of the Main screen in Figure 1.17 just
above the Menu Bar (4). It shows the current state of the system: either Running,
Standby or Stopped. When both the Modular Chemistry (MC) and the Cartridge
Chemistry (CC) functions have the same status, a single status indicator appears.
When the statuses of these components are different, the MC Status is shown on
the left, and the CC Status appears on the right. For example, Running/Standby
would indicate that the MC side is Running, and the CC side is in Standby mode.
A13914AF
System Description
Main Screen and Program Structure
Sample Status Indicators
Refer to Figure 1.17. When monitoring sample status, a sample status icon appears in front of listed
samples. Samples are listed in a rack status box directly below the sample status icon legend (5). The
sample statuses shown are as follows:
Table 1.14 Sample Status Indicators
Status Indicator
A13914AF
Status Description
Not Programmed
Indicates a sample has been loaded without any programming associated with that
Sample ID.
Query Pending
Sample is waiting for specific program information to be downloaded from the host.
In Progress
Sample has been identified and is currently being processed.
Aspirated
Indicates whether an initial aspiration of the sample has been accomplished.
Incomplete
Sample has some tests that are still pending.
Complete
All tests for sample have been completed.
1-29
1
System Description
Main Screen and Program Structure
Menu Bar Icons and Program Structure
Near the top of the Operator screens, a series of icons on the touch screen provide access to each of
the major functional areas of the system (4) (refer to Figure 1.17).
Figure 1.18 Program Structure (Main, Samples)
1-30
A13914AF
System Description
Main Screen and Program Structure
Figure 1.19 Program Structure (Results, Rgts/Cal)
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1-31
1
System Description
Main Screen and Program Structure
Figure 1.20 Program Structure (QC, Setup)
1-32
A13914AF
System Description
Main Screen and Program Structure
Figure 1.21 Program Structure (Setup - continued)
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1-33
1
System Description
Main Screen and Program Structure
Figure 1.22 Program Structure (Setup - continued)
1-34
A13914AF
System Description
Main Screen and Program Structure
Figure 1.23 Program Structure (Utils)
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1-35
1
System Description
Main Screen and Program Structure
Figure 1.24 Program Structure (Utils – continued)
1-36
A13914AF
System Description
Main Screen and Program Structure
Figure 1.25 Program Structure (Utils – continued, Status, Instr Cmd, and Help)
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1-37
1
System Description
Main Screen and Program Structure
Recall Results for On-board Samples
To preview the results of tests In Progress, before the rack is unloaded from the system, perform the
following procedure.
1
Select the sample for the desired results. The sample is highlighted.
2
Select Results F1. The results for any completed tests for the requested sample are shown along
with the status of any pending tests.
3
Select one of the function keys:
•
Print F8 - to send completed results to the printer.
•
Host F6 - to send completed results to the host.
Accessing the Help System
Help is available online in multiple supported languages. To reach the online Help system,
• Select the Help icon
, or
• Use the combination keys (ALT) + (F1) from any screen.
The manual opens up full-screen in the language selected in System Setup. You can use the
combination keys (ALT) + (F1) to toggle between the active screen and the last accessed page of
the online manual.
Online Manual Links
The system may display an “Error -- The page cannot be displayed” pop-up message when you select
the Event ID button to link to the online manual from an instrument pop-up error message, or when
you select a link in the online manual. To continue, record the Event ID, select OK from the Error
pop-up message, and then use the search feature of the online manual to find the topic you were
seeking.
NOTE To view the instrument pop-up error Event ID number, use the (ALT) + (F1) key combination to return
to the instrument screen.
Print Data From a Screen
Many screens contain data that may be printed by selecting Print F10. Pressing the (PrtScn) key on
the keyboard also causes the current screen to print, regardless of whether the Print F10 option is
available.
1-38
A13914AF
System Description
Main Screen and Program Structure
Rack Status Area
These boxes, Figure 1.17 (6), represent the ten possible rack locations on the Sample Carousel. As
each rack is loaded, the rack number is displayed at the top of the Rack Status box. All sample IDs on
the rack are listed below the rack number. The Sample Status icons described earlier indicate
sample status.
STAT Highlighting
Any sample programmed as a STAT is highlighted in a yellow rack status box on the Main screen.
Additional Function Keys
Other functions may also be accessed through the Main screen.
• Results F1 - Retrieves results for samples that are In Progress on the system.
• Unload F2 - Requests particular racks to be unloaded at the next possible opportunity.
•
Log F8 - Lists errors detected on samples, for example, incomplete tests, host query timeout,
duplicate sample ID, programming conflict. If the error is logged, the Log F8 key is highlighted
in yellow. The yellow highlight disappears when the key is selected. The error will stay in the
Sample Log screen for 12 hours.
• Pre Run Summary F9 - Lists reagent and calibration status, as well as sample programming
needs.
• Post Run Summary F10 - Lists error conditions which have occurred on the system, including
suppressed results and no sample detected.
These functions are covered more thoroughly in the following sections.
Request a Sample for Unload
To unload racks that contain specific samples perform the following procedure.
1
Select the rack to unload. The rack is highlighted.
2
Select Unload F2. The rack is offloaded at the earliest opportunity.
Sample Log
The sample log feature provides a method to review the status of any incomplete patient and control
samples that have been off the system for less than 12 hours.
A13914AF
1-39
1
System Description
Main Screen and Program Structure
The samples in the log are arranged in a first in, first out sequence. When a new sample comes in
at the top of the list, the other sample(s) move down one space. Samples will remain on the list until
their status changes to "Complete" or they are on the list for more than 12 hours.
Request the Log
Table 1.15 Operations with the Sample Log
To...
Select...
See the log
Log F8 from the Main screen
See more pages
(Page Up) or (Page Down)
Print the log (present list of sample history)
PRINT
NOTE This printout contains the same information as the
body of the window. This window remains in view after
the print button is selected.
Exit and return to the Main screen
OK
Description of Log Fields
Table 1.16 Sample Log Fields
Field
Description
Rack
The rack in which the sample was run.
Position (Pos)
The position of the sample in the rack when it was run.
Sample ID
There are two ways to get this sample ID:
1. The system reads the bar code.
2. Manually input a sample program.
If there is no sample ID, there are two possible fields:
• If there is no sample ID then "NO ID" appears.
• If there is no sample ID and it is required, then a status of
Not Programmed appears.
IMPORTANT The Not Programmed status is used for samples for which:
• A bar code was read, but no programming was found.
• A bar code was not read, and no manual sample programming was
found for that rack and position.
Updated
This is the time and date that the sample entry was last updated.
The time and date is displayed in the format selected in System Setup
(12 or 24-hour clock and month/day or day/month).
1-40
A13914AF
System Description
Main Screen and Program Structure
Table 1.16 Sample Log Fields (Continued)
Field
Status
Description
• If there are two results because of a Critical Sample Rerun, the log entry
shows:
— Review Results
• If an incomplete sample is removed from the sample carousel, the log entry
shows one of the following status indications:
— Incomplete
— Sample Required
— Not Programmed
— Removed
— Rerun
— In Progress
IMPORTANT "In Progress" means a sample load error. Refer to the list
below for more status indications for some of these errors.
• If some CC results are still incubating, the sample status shows Removed
when it is first taken off the sample carousel. In this case, the sample is
deleted from the list when it goes to Complete. If it does not go to Complete,
more status strings are added, as applicable. Possible statuses are listed
below:
— Duplicate Sample ID
— Editing Sample
— Programming Conflict
— Barcode ID Too Long
— Invalid Barcode Char(acter)
— Host Query Timeout
• The Status updates when the sample is:
— loaded and an error condition is detected
— removed from the sample carousel
— completed with all its tests
A13914AF
1-41
1
System Description
Main Screen and Program Structure
Pre Run Summary
The Pre Run Summary is a printed report containing summary information about the programmed
tests for each chemistry. This information helps in determining the status of the reagents to verify
that the system is in a condition to complete the requested tests.
Information includes:
• reagent volume/tests available for resident reagents
• calibration time remaining and cal status
• lot and serial number of cartridge
• reagent status/on-board life
• number of tests programmed versus available for on-board reagents
• number of test programmed for non-resident reagents
Request a Pre Run Summary
1
If not currently in the Main screen, select the Main icon from the menu bar.
2
Select Pre Run F9. The Pre Run summary prints automatically. It may take up to 25 seconds to
start to print.
Post Run Summary
The Post Run Summary option provides a printed list of the samples that are pending or incomplete,
with an explanation of the status. Incomplete or Suppressed tests are generated due to a reagent or
calibration situation. To run a Pending test, simply reload the rack or bar code labeled tube. Results
for reloaded, incomplete tests replace results that were previously incomplete. Reloaded sample
results are collated with the existing reported tests in the sample report.
Request a Post Run Summary
1
If not currently in the Main screen, select the Main icon from the menu bar.
2
Select Post Run F10. The Post Run Summary prints automatically.
NOTE The Post Run Summary may require up to 7 minutes for printing.
1-42
A13914AF
System Description
Theory of Operation
Theory of Operation
Introduction
The UniCel DxC Synchron Clinical Systems are microprocessor-controlled, random access clinical
analyzers capable of processing a wide variety of operator-selected chemistries in a single run.
Cartridge Chemistries (CC)
The optical system of the DxC enables rate, endpoint, and nonlinear analyses to be performed
simultaneously. These analyses are referred to as cartridge chemistries because the reagents are
stored in cartridges.
Cartridge Chemistry (CC): Sample and Reagent Processing
During operation, a number of events occur simultaneously and are under direct control of the
instrument microprocessors.
Cartridge Chemistry: Calibration Theory
Introduction
Calibration determines the relationship between measured reaction responses and known
concentrations. Calibration factors are derived from this relationship. These factors are used to
convert the measured reaction responses to final concentration results.
Calibrated chemistries include endpoint and first-order rate chemistries, drugs, DATs, and specific
proteins. Zero-order rate chemistries include enzymes, which are precalibrated and require no
routine calibration. Enzyme verification can be performed on some of the enzymes to conform to
International Federation of Clinical Chemistry (IFCC) guidelines at +37°C.
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1-43
1
System Description
Cartridge Chemistry: Calibration Theory
Endpoint and First-Order Chemistries
Calibration of endpoint and first-order rate chemistries involve the use of a single-level calibrator
solution or a two-level calibrator kit. Each analyte in the calibrator solution has a known
concentration value associated with it. With each new lot of calibrator solution, the values are
transferred from disk and stored in memory for later use in the calibration procedure.
For most calibrated cartridge chemistries, the system will set calibration factors based on four
calibrator replicates per calibrator level. The instrument will determine and discard the highest and
lowest of the four replicates. The remaining two values are called the usable calibrator replicates.
All four replicates will appear on the report but the average of the two usable replicates is used to
determine the calibration factor.
For other chemistries, calibration is based on two calibrator replicates per calibrator level. No
replicates are discarded. The average value of the calibrator replicates is used to determine the
calibration factor.
Endpoint and First-Order Calibration Formulas
The calibration factor is determined by using one of the following equation sets where reaction and
blank are used from the usable replicates.
1-44
A13914AF
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries
Type
Nonblanked
Endpoint
Chemistries
Formula
FOR HIGH CALIBRATOR LEVEL:
Reaction ABS = ABSrep1
Reaction ABS = ABSrep2
(ABSrep1 + ABSrep2) × 0.5 = ABSavg(hi)
FOR LOW CALIBRATOR LEVEL:
Reaction ABS = ABSrep1
Reaction ABS = ABSrep2
(ABSrep1 + ABSrep2) × 0.5 = ABSavg(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
ABSavg(hi) – ABSavg(lo)
E014416L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × ABSavg(hi)]
Sample values are calculated by the following equation:
(Reaction ABS × Cal Factor) + offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
Blanked Endpoint FOR HIGH CALIBRATOR LEVEL:
Chemistries
(Reaction ABS - Blank ABS) = Delta ABSrep1
(Reaction ABS - Blank ABS) = Delta ABSrep2
(Delta ABSrep1 + Delta ABSrep2) × 0.5 = Delta ABSavg(hi)
FOR LOW CALIBRATOR LEVEL:
(Reaction ABS - Blank ABS) = Delta ABSrep1
(Reaction ABS - Blank ABS) = Delta ABSrep2
(Delta ABSrep1 + Delta ABSrep2) × 0.5 = Delta ABSavg(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Delta ABSavg(hi) – Delta ABSavg(lo)
E014417L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Delta ABSavg(hi)]
Sample values are calculated by the following equation:
[(Reaction ABS - Blank ABS) × Cal Factor] + offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
A13914AF
1-45
1
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Formula
Blanked Endpoint FOR HIGH CALIBRATOR LEVEL:
Chemistries
(with Volume
Correction)
Blank Correction Factor =
=
Blank Volume
Total Reaction Volume
Volume of Reagent(s) (and Sample) at Blank Read
Volume of Total Reagent and Sample at Reaction Read
E007123L.EPS
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABSrep1
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABSrep2
(Delta ABSrep1 + Delta ABSrep2) × 0.5 = Delta ABSavg(hi)
FOR LOW CALIBRATOR LEVEL:
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABSrep1
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABSrep2
(Delta ABSrep1 + Delta ABSrep2) × 0.5 = Delta ABSavg(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Delta ABSavg(hi) – Delta ABSavg(lo)
E014417L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Delta ABSavg(hi)]
Sample values are calculated by the following equation:
[[Reaction ABS - (Blank ABS × Blank Correction Factor)] × Cal Factor]
+ offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
1-46
A13914AF
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Formula
Nonblanked Rate FOR HIGH CALIBRATOR LEVEL:
Chemistries
Reaction Rate = Raterep1
Reaction Rate = Raterep2
(Raterep1 + Raterep2) × 0.5 = Rateavg(hi)
FOR LOW CALIBRATOR LEVEL:
Reaction Rate = Raterep1
Reaction Rate = Rate rep2
(Raterep1 + Raterep2) × 0.5 = Rateavg(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Rateavg(hi) – Rateavg(lo)
E014418L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Rateavg(hi)]
Sample values are calculated by the following equation:
(Reaction Rate × Cal Factor) + offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
A13914AF
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1
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Blanked Rate
Chemistries
Formula
FOR HIGH CALIBRATOR LEVEL:
(Reaction Rate - Blank Rate) = Delta Raterep1
(Reaction Rate - Blank Rate) = Delta Raterep2
(Delta Raterep1 + Delta Raterep2) × 0.5 = Delta Rate avg(hi)
FOR LOW CALIBRATOR LEVEL:
(Reaction Rate - Blank Rate) = Delta Raterep1
(Reaction Rate - Blank Rate) = Delta Raterep2
(Delta Raterep1 + Delta Raterep2) × 0.5 = Delta Rateavg(lo)
Offset = Cal Set Point (hi) - [Cal Factor × Delta Rateavg(hi)]
Sample values are calculated by the following equation:
[(Reaction Rate - Blank Rate) × Cal Factor] + offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
1-48
A13914AF
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Blanked Rate
Chemistries
(with Volume
Correction)
Formula
FOR HIGH CALIBRATOR LEVEL:
Blank Correction Factor =
=
Blank Volume
Total Reaction Volume
Volume of Reagent(s) (and Sample) at Blank Read
Volume of Total Reagent and Sample at Reaction Read
E007123L.EPS
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Raterep1
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Raterep2
(Delta Raterep1 + Delta Raterep2) × 0.5 = Delta Rateavg(hi)
FOR LOW CALIBRATOR LEVEL:
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Raterep1
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Raterep2
(Delta Raterep1 + Delta Raterep2) × 0.5 = Delta Rateavg(lo)
Offset = Cal Set Point (hi) - [Cal Factor × Delta Rateavg(hi)]
Sample values are calculated by the following equation:
[[Reaction Rate - (Blank Rate × Blank Correction Factor)] × Cal Factor]
+ offset = sample value
IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point
and the offset is equal to zero.
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1
System Description
Cartridge Chemistry: Calibration Theory
Non-Linear Chemistries
Non-linear chemistries include drugs and specific protein assays. Unlike the first-order rate and
endpoint chemistries, which exhibit a linear response to increasing concentration, the calibration
curves for non-linear chemistries exhibit logarithmic (S-shaped) or other nonlinear relationships.
For this reason, curve fitting interpolation techniques are employed to construct the calibration
curve.
For some non-linear calibrations, the curve parameters for a reagent lot are calculated during
manufacturing. The curve parameters are encoded in bar code form, shipped on a card in the
reagent box and loaded onto the system. A single point calibration is then run to adjust for
instrument-to-instrument variation. If necessary, the calibration includes the sample diluent
(DIL1), used as a blank, that is subtracted from all calibrator or sample responses.
• Multi-point chemistry calibration consists of five or six different levels of calibrators. These
chemistries set calibration based on single replicates of each calibrator level.
• Single-point chemistry calibration consists of one or two levels of calibrators. These
chemistries set calibration based on two to four replicates of each calibrator level.
Non-Linear Calibration Formulas
The standard curve is determined by use of one of several nonlinear math models. The system uses
an iterative technique to calculate the curve parameters. A modified Newton iteration is used to
choose values. The best-fitting calibration curve is determined by minimizing the sum of the
difference between the observed response and the calculated response of each standard.
The following symbols are used in the math models presented below:
1-50
R
= sample response
Conc
= standard or sample concentration
R0
= calculated response for a zero sample
Kc
= scale parameter
a, b, c
= parameters which define the nonlinear elements of the math model
A13914AF
System Description
Cartridge Chemistry: Calibration Theory
Table 1.18 Math Models for Non-Linear Chemistries
Type
Model #1
Formula
Math Model #1 is the four-parameter log-logit function most commonly used with
reagents that use antibodies.
Sample values are determined using the calculated curve parameters and the math
model. Values may be calculated directly as this model can be solved for concentration.
Model #2
Math Model #2 is a five-parameter logit function.
E014421L.EPS
This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.
Model #3
Math Model #3 is a five-parameter exponential function.
This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.
Models #4
through #7
These Models are reserved for future development.
Model #8
Math Model #8 is an alternative to model #2, the five-parameter logit function.
This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.
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1
System Description
Cartridge Chemistry: Calibration Theory
Table 1.18 Math Models for Non-Linear Chemistries (Continued)
Type
Model #9
Formula
Math Model #9 is an extension to model #1, the four-parameter log-logit function.
The "c" is allowed to be either +1 or -1.
If c = +1, then this is equivalent to model #1.
If c = -1, an alternative function is being used.
This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.
Polynomial
Exponential
(PXP)
E014476L.EPS
Quadratic
(POLY2)
E014477L.EPS
Lorentz
E014478L.EPS
Double Inflection
Model DP4
R=
Kc1
a1
1+
conc
+
Kc2
a2
1+
conc
E011537L.EPS
1-52
A13914AF
System Description
Modular Chemistry: Calibration Theory
Drugs of Abuse Testing (DAT) Chemistries
The Drugs of Abuse Testing (DAT) assays require three levels of calibrators. The calibration
measures the separation between calibrators to measure reagent integrity. The calibration factor
generated is non-functional for sample result calculation.
The cutoff value for each DAT chemistry represents the mean reaction rate of the low calibrator,
reported in mA/min units on patient and control reports. The reaction rate of the samples is
compared to the reaction rate of the low (cutoff) calibrator and reported out as POSITIVE or
NEGATIVE. Cutoff values are stored in memory until the next successful calibration.
Enzyme Verification
Enzyme verification is a means of adjusting enzyme chemistry reporting units to IFCC/DGKCh
methods. This feature is available for ALP, ALT-, AST-, CHE, CK-, GGT and LD. Verification also allows
results to be adjusted for country specific correlation needs.
Verification is similar to calibration except that normalization factors are applied to the sample
result in the form of a slope and offset adjustment, whereas calibration factors would be applied to
the reaction response.
Modular Chemistry: Calibration Theory
Calibration Theory
Modular chemistries are calibrated using two to three levels of calibrator (chemistry dependent).
Four replicates per level are assayed. Data from two middle replicates of each level is used to set the
system response. The highest and lowest replicates are discarded. Error checks are performed on
the two middle replicates to verify successful calibration.
Calibration Error Detection
The analog signals generated by the calibrator measurements are converted to digital form. The
resulting ADC values are compared to pre-programmed back-to-back, span and range limits to
determine the calibration acceptability.
Modular Chemistries (MC)
The UniCel DxC contains seven chemistry modules (see chart below), each of which is used in the
determination of eleven modular chemistries (MC), as follows.
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1
System Description
Cartridge Chemistry: Principles of Measurement
Table 1.19 Methodology and Modules Used with Modular Chemistries
Chemistry
Methodology
Module
Sodium
Ion selective electrode (ISE)
ISE Flow cell
Potassium
Ion selective electrode
ISE Flow cell
Chloride
Ion selective electrode
ISE Flow cell
Carbon Dioxide
pH electrode
ISE Flow cell
Calcium
Ion selective electrode
ISE Flow cell
Conductivity electrode
Urea Nitrogen
Phosphorusa
Colorimetric
Phosphorus
Creatininea
Colorimetric
Creatinine
Glucose
Oxygen sensor
Glucose
Total Proteina
Colorimetric
Total Protein
Albumina
Colorimetric
Albumin
Urea
Nitrogena
a. DxC 800 only.
Cartridge Chemistry: Principles of Measurement
Spectrophotometric Methods
Spectrophotometric methods rely on the principle that a sample, such as a patient sample, a
control, or a calibrator, when mixed with one or more appropriate chemical reagents, produces a
substance that has the ability to absorb light at specific wavelengths. This substance is referred to
as a chromophore.
Beer's Law
According to Beer's Law, the amount of light absorbed by the chromophore is proportional to the
concentration of the constituent being measured. The system can measure this as an endpoint or a
rate of formation.
A = abc
where
1-54
A
= absorbance of the chromophore
a
= absorptivity of the absorbing substance at the specific measuring wavelength(s)
b
= cuvette light pathlength (cm)
c
= constituent concentration (M)
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CHAPTER 2
Preparing Samples for Analysis
Routine Operation Overview
Daily Procedure
The following procedure shows an example of daily work flow using the UniCel DxC Synchron
Clinical System.
IMPORTANT This procedure assumes that the initial system setup has been completed.
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1
If necessary, start the system.
2
Check reagent status. Load reagent as necessary.
3
Check calibration. Program or load calibrators as needed.
4
Program or load controls, if required.
5
If the system is not already running, press RUN on the system.
6
Check the control results to verify system operation.
7
Program or load patient samples.
8
If the system has gone into Standby, press RUN on the system.
9
Review the patient results.
2-1
Preparing Samples for Analysis
Preparing Samples for Analysis
10 Return to Step 7 if more samples need to be run.
11 The system automatically returns to Standby when all testing is completed.
Preparing Samples for Analysis
Minimum Sample Volume
A minimum sample volume is required to run tests. To determine what volume of sample to use,
refer to the Synchron LX/UniCel DxC Clinical Systems Sample Template.
Sample Racks
Sample racks accept the following tube and cup sizes:
Table 2.1 Sample Racks
Rack
Accepts these cups and tubes
13 × 75
12 × 75 mm tubes
13 × 75 mm tubes
0.5 mL cups
2.0 mL cups
16 × 75
16 × 75 mm tubes
13 × 100
13 × 100 mm tubes
0.5 mL cups
2.0 mL cups
Capillary collection tubes (use with the capillary tube adapter)
16 × 100
16 × 100 mm tubes
16.5 × 92 mm tubes
Beckman Coulter 0.5 mL Cup Insert (PN 467406)
IMPORTANT Adapters are provided to adapt various sized sample tubes (secondary tubes) to the short
racks. These adaptors must only be used in racks designated as reserved. The reserved rack feature is
described in this chapter.
2-2
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Preparing Samples for Analysis
Preparing Samples for Analysis
Sample Preparation by Container Type
Table 2.2 shows how to prepare different sample containers.
Table 2.2 Preparation of Sample Containers
If running a sample from a...
Then...
Primary Tube
• Use the Synchron LX/UniCel DxC Clinical Systems Sample Template to
determine adequate sample volume.
• Remove the cap if not using CTS.
• For CTS systems, remove the cap, if not a validated closed tube.
Secondary Tube
• Determine sufficient volume.
• Check for fibrin or other materials resulting from storage.
Beckman Coulter Synchron
Microtube
•
•
•
•
Sample Cup
0.5 mL
(PN 651412)
• Place the cup into a 13 × 75 mm, or a 13 × 100 mm rack.
OR
• Place the cup in 15 × 85 mm tube into a 16 × 100 mm rack.
• Make sure there are no bubbles in sample.
• If cup is placed in a 15 × 85 tube with a Bar Coded label, a "reserved rack"
must be used.
2.0 mL
(PN 652730 or
81902)
0.5 mL
2.0 mL
Place into a 13 × 100 mm rack.
Pipette the sample into a Synchron Microtube.
Make sure there are no bubbles at the bottom of the tube.
A "reserved rack" must be used.
E014498L.EPS
• Place Microtainer in adapter (PN 472987).
(Refer to figure to the right.)
BD Microtainer
• Make sure there are no bubbles in sample.
• A "reserved rack" must be used.
• Place the metal Cup Insert into a 16 × 100 mm rack.
• Insert a 0.5 mL cup into the Cup Insert.
• A "reserved rack" must be used.
0.5 mL Cup Insert
(PN 467406) (reusable)
A011538L.EPS
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2-3
2
Preparing Samples for Analysis
Preparing Samples for Analysis
Bar Code Labeling
The use of bar code labels is a highly accurate and efficient method for identifying and processing
laboratory samples. However, the system must be able to identify and read every bar code label to
process each sample correctly. The following paragraphs provide some basic information
pertaining to bar code labels. Additional bar code information can be found in the UniCel DxC
Synchron Clinical Systems Reference Manual.
CAUTION
A misread label can cause one sample ID to be read as another. The laboratory’s
process for printing, placing, and meeting all bar code specifications is important
to achieve highly accurate reading. Follow the bar code label specifications to
keep the rate of misread labels to a minimum.
Bar Code Label Placement
Bar code labels must be applied to each sample tube in the correct location so that the bar code
reader can read the bar code. The following diagram (Figure 2.1) describes how to place the label on
a sample tube and how to place the tube into a sample rack.
Figure 2.1 Bar Code Label Placement
4
1
2
3
4
A014600L.EPS
1.
2.
3.
4.
2-4
14 mm (0.55 inch) Minimum
Label Placement Area
20 mm (0.78 inch) Minimum
7.5 Degree Maximum
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Preparing Samples for Analysis
Preparing Samples for Analysis
Sample Tubes Validated for CTS
Capped tubes can be run directly on the system without removing the cap. The CTS assembly cuts
a small hole in the cap and the sample probe aspirates a sample directly from the tube. With this
procedure, samples are processed faster and more safely.
CTS Validated Sample Tubes
Only validated sample tubes can be run on UniCel DxC Systems with CTS. However, capped and
uncapped tubes can be placed on the same rack. Refer to the table below for validated tubes.
Table 2.3 Tubes Validated for Closed Tube Sampling
CTS Configuration
1-Blade Thick CTS
1-Blade Narrow CTS
Tubes Validated for Cap Piercing
Size
Becton Dickinson VACUTAINER with HEMOGARD
13 × 75mm
13 × 100 mm
16 × 100 mm
Greiner VACUETTE
13 × 75mm
13 × 100 mm
Sarstedt S-Monovette
75 × 15 mma
92 × 15 mm
a. This tube requires a special 5.5 mL rack (PN A18642).
CAUTION
Before placing validated closed tubes on the UniCel DxC Systems, check the top of
the cap for any residual blood. Residual blood can contaminate the sample and
affect results. If blood is present, remove it by using a cotton-tipped applicator
stick moistened with DI water. When running in the CTS mode, if tubes off-loaded
from the UniCel DxC Systems have water or droplets of water on the caps, disable
the CTS and contact Beckman Coulter Support Center. Note: Oil on a cap is normal.
Closed Tube Sampling (CTS)
This is an optional feature that allows the system to pierce primary sample tubes. If a CTS assembly
is installed, the operator can enable/disable the CTS assembly. A CTS Tracking database monitors
pierced tubes. If you run a tube again, it will not be pierced again. The sample ID stays in this
database for seven days for a tube that has been pierced.
When a particular Sample ID is manually cleared through Sample Programming, the CTS Tracking
information is also cleared for that Sample ID. If the tube with this particular Sample ID was
previously pierced, reloading this sample tube on any tracking networked instrument will cause it
to be repierced.
NOTE If a sample ID is cleared at the Host (LIS), the sample ID is NOT cleared in the CTS Tracking database.
• If a previously pierced sample needs to be rerun, do not clear the Sample ID; use the rerun
procedure.
• If a Sample ID is manually cleared and reprogrammed for a previously pierced sample, remove
the cap to prevent repiercing.
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2-5
2
Preparing Samples for Analysis
Preparing Samples for Analysis
• If a Sample ID is reused for an unpierced sample, clear the Sample ID on the instrument, the cap
does not need to be removed.
• If you need to clear the CTS database (for example, if the host system's counter rolls over and
uses the same Sample IDs again), clear the Sample IDs at any of the instruments connected by
the tracking network.
Follow the steps below to verify Sample ID clearing status.
1
Select Samples from the menu bar.
2
Type the sample ID.
3
Press (Enter) .
4
Does the sample have its initial program?
• If the sample has its initial program:
— Do NOT remove its cap.
— Run the sample.
• If the sample does NOT have its initial program (the ID has been cleared):
— Remove its cap.
— Run the sample.
2-6
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Preparing Samples for Analysis
How to Use Reserved Racks
How to Use Reserved Racks
When NOT to Use a Reserved Rack
When you use CTS (Closed Tube Sampling), do NOT run a closed tube in a reserved rack.
Reserved Racks
If a rack number is entered into this field, any sample containers in this rack will not be cap pierced
even if the Cap Piercing feature is enabled. Level sensing on samples in the rack is set to the most
sensitive level to detect small sample volumes. This type of reserved rack may be used for
uncapped, primary or secondary tubes that have a small volume of sample, for example: nested cups
on primary tubes, Microtubes and pediatric capillary collection tubes.
IMPORTANT To identify a reserved rack, put a red ® on the front of the rack.
Reserved Racks for HbA1c, or IBCT
There are two separate fields for specific tests. One for HbA1c and one for IBCT. If a rack number is
entered into one of these fields, any samples run in that rack will only function for that specific test.
For example, Rack 66 is entered into the Reserved Racks for HbA1c field. Any sample placed in that
rack can only have an HbA1c/HbA1c2 run on it. The reason for this is that each test in this group
requires some sort of sample preparation. If these tests are part of a group of other tests that do not
require preparation, they cannot be run at the same time as the others. Using these features allows
the prepared sample to be run in one of the reserved racks and allows the result of the prepared
sample to be merged with the original sample report when all tests are complete.
IMPORTANT Even if the Auto Serum Index feature is enabled, no serum indices are run for the pre-treated
HbA1c and pre-treated IBCT samples run in these reserved racks.
The default for each of these features is:
• CTS = OFF,
• Reserved racks = none reserved,
• Obstruction detection = On,
• Reserved racks for HbA1c or IBCT = none reserved.
These features can only be modified when the system is in Standby, Stopped, Startup, Instrument
Down, or Homing state.
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2-7
2
Preparing Samples for Analysis
How to Use Reserved Racks
Assigning or Reassigning Reserved Racks
1
Select Setup from the menu bar.
2
Select Page Down on the right side of the screen.
3
Select 17 Reserved Racks/Obstruction Detection. The following screen appears.
Figure 2.2 Reserved Racks/Obstruction Detection Setup Dialog Box
E015928S.EPS
4
Type the rack numbers to assign as reserved racks in the HbA1c and IBCT fields.
AND/OR
Type the rack numbers to assign as reserved racks.
5
2-8
Select OK to assign the racks.
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CHAPTER 3
System Setup Options
Overview
Introduction
This chapter summarizes the 29 System Setup options depicted on the Setup screens shown in
Figure 3.1 and Figure 3.2 below:
Figure 3.1 Setup Screen (scrolled to the top)
E011951S.EPS
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3-1
System Setup Options
Password Setup
Figure 3.2 Setup Screen (scrolled to the bottom)
E015931S.EPS
For detailed step-by-step instructions on using the System Setup option, refer to the UniCel DxC
Synchron Clinical Systems Reference Manual.
Password Setup
Introduction
The Password Setup option allows the operator to:
• Assign up to 100 user names and their passwords
• Assign Administrator or Operator level privileges to each user name
• Define/edit or delete user name/password setup
• Enable/disable security for accessibility to certain system functions and setups
The following features may be password secured:
• Results, Edit
• Rgts/Cal, Modify Set Points
• Rgts/Cal, Slope/Offset Adjustment
• Rgts/Cal, Within-Lot Calibration
• Rgts/Cal, Enzyme Validator
• QC
• Setup
• Utils, Clear Event Log
3-2
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System Setup Options
Password Setup
Defining/Editing Password Setup
To define, edit or delete user names, passwords, privilege levels and accessibility levels, follow the
procedure below.
1
Select Setup from the menu bar.
2
Select 28 Password Setup from the Setup screen.
3
Enter an Administrator password in the Administrator Password dialog box.
• Select OK.
OR
• Select Cancel to return to the System Setup menu.
NOTE After a software install, the default password is beckman.
4
The Password Setup dialog box shows Page 1 (of 10) of the users with password security. If
necessary, select Page Down on the right side of the screen to show the user desired.
• Select New F1 to enter the password setup for a new user.
OR
• To edit the password setup for a user, select the user’s password number.
OR
• Type the user’s password number in the Numbers field.
• Select Define F2.
5
In the Define/Edit Password dialog box, enter the information requested.
IMPORTANT Do NOT type beckman in the Password field.
• Select Administrator in the Title field to allow the user to modify password setup.
OR
• Select Operator in the Title field to NOT allow the user to modify password setup.
• Select OK.
OR
• Select Cancel to return to the Password Setup screen.
6
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The new or edited user is now in the Password Setup screen in alphabetical order by last name.
3-3
3
System Setup Options
Auto Serum Index/ORDAC
Refer to the UniCel DxC Synchron Clinical Systems Reference Manual for additional information on
deleting users from the Password List, and enabling and disabling password security for functions.
Auto Serum Index/ORDAC
Auto ORDAC
Auto ORDAC permits the enabling or disabling of the automatic Overrange Detection and Correction
(ORDAC) function for specified chemistries (refer to the Synchron Clinical Systems Chemistry
Information Manual and to the list of chemistries offering ORDAC in the Synchron Clinical Systems
Chemistry Reference Manual). When a chemistry result exceeds the instrument analytical range and
Auto ORDAC is enabled, the sample automatically reruns with either:
• a smaller sample size or
• an online sample dilution (chemistry dependent).
When Auto ORDAC for Ig-A and Haptoglobin is enabled, the URDAC feature is also enabled. Ig-A and
Haptoglobin URDAC is used to analyze samples with concentrations below the analytical range. In
this case, the system takes a larger sample volume.
(The manual ORDAC function in Sample Programming is used for samples which are known to
exceed the analytical range. Chemistries designated with manual ORDAC at the time of
programming are run at the ORDAC sample volume.)
From the Setup screen, select 1 Auto Serum Index/ORDAC to enable or disable ORDAC. The default for
Auto ORDAC is OFF.
The Automatic ORDAC screen may be viewed at any time, however the system must be in Standby,
Stopped, Startup, Instrument Down, or Homing to modify the ORDAC selection.
IMPORTANT The analytical ranges for each analyte are system limits found in the respective CISs. These
are the ranges that Beckman Coulter has verified can be achieved by the system. There is no flagging
associated with values exceeding these limits.
The instrument printable ranges for each analyte are internal system limits. These ranges actually exceed
the analytical ranges by a certain limit. This allows for precision variations and still permits a result to print
even though it slightly exceeds the analytical range. Results outside this range are suppressed. The
suppressed results are flagged OIR HI or OIR LO (Out of Instrument Range).
Auto Serum Index
The Auto Serum Index function may apply to control material used in your lab. When enabled, Auto
Serum Index automatically analyzes every serum and plasma sample for the presence of hemolysis,
icterus and lipemia and numeric values (indices) for the relative concentrations are included in the
report.
The values are printed below the Special Calculations area of a patient report. The values are printed
with the test results for a control sample.
3-4
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System Setup Options
Configuring the Chemistry Menu
Auto Serum Index is intended for sample integrity assessment only; not for patient diagnosis.
IMPORTANT When running the system with Automatic Serum Index enabled, remember to manually
disable the serum index feature when choosing options to set the replicates. This prevents running
indices needlessly.
For additional information on Serum Index, refer to the Synchron Clinical Systems Chemistry
Reference Manual.
From the Setup screen, select 1 Auto Serum Index/ORDAC to enable/disable Auto Serum Index.
To enable or disable Auto Serum Index, the system must be in Standby, Stopped, Startup, Instrument
Down, or Homing.
The default for Auto Serum Index is OFF.
Configuring the Chemistry Menu
Introduction
• The Chemistry Configuration function accommodates the installation of desired tests from a
comprehensive list of available chemistries.
• Of the total tests available, 180 chemistries can be selected and positioned onto the menu at one
time and customized to match the test order on the lab request forms.
• Modular chemistries (MC) are permanently configured on the system. These chemistries may
be relocated on the configuration screen, but not removed.
• BUNm and UREAm are both displayed as available chemistries on the DxC 800. However, only
one may be configured at a time. The selected chemistry is configured during software
installation.
• The Chem Configuration/Default Sample Type screen may be viewed at any time, but
modifications can only be made when the system status is Standby, Stopped, Startup, Instrument
Down, or Homing.
Configuring a Beckman Coulter Chemistry
The chemistry menu, available in sample programming, quality control, panel definition and other
screens, is defined by the user. To define Beckman Coulter chemistries, select 2 Chemistry
Configuration/Sample Type from the Setup screen. Place the cursor in an open field in the Chem
Configuration/Default Sample Type screen and press Chems F1. Select the DxC chemistry from the
pop-up list.
Configuring a User Defined Chemistry (UDR)
The chemistry menu available in sample programming, quality control, panel definition and other
screens is defined by the user. After a User Defined Chemistry (UDR) has been defined by selecting
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3-5
3
System Setup Options
Configuring the Chemistry Menu
15 User-Defined Chemistries from the Setup screen, you can Configure the UDR by selecting
2 Chemistry Configuration/Sample Type from the Setup screen. After the Chem Configuration/Default
Sample Type screen appears, selecting UDR F2 presents a list of all User Defined Chemistries on the
system. Refer to CHAPTER 8, User Defined Reagents in this manual for additional information on
application of user-defined parameters.
Defining Chemistry Print Name
The Define Print Names function permits definition of the chemistry name that appears on the
chartable report. Each chemistry may be given a name of a maximum of 15 characters. To define the
chemistry print name, select 2 Chemistry Configuration/Sample Type from the Setup screen. Select
Define F3 from the Chem Configuration/Default Sample Type screen to use the Define Print Names
screen.
Inserting a Chemistry
The Insert function inserts a blank position for adding a chemistry to the menu. After a blank
position is inserted, the chemistries following that position are incremented by one position. If 180
is exceeded, the last one is dropped. From the Setup screen, select 2 Chemistry Configuration/Sample
Type. Refer to the UniCel DxC Synchron Clinical Systems Reference Manual for additional
information on this procedure.
Deleting a Chemistry
The Delete Chemistry function requires that you first clear the calibration, sample programming
and control (QC) information from the instrument before deleting the chemistry from the system.
Where it is used, Beckman Coulter recommends that you remove chemistries from the system
following the sequence and procedures below to prevent problems with deleting chemistries from
the QC definition:
IMPORTANT Control samples in the "sample required," "incomplete" or "rerun" status may prevent the
removal of the chemistry from the QC definition.
Remove the Chemistry from Reagent/Calibration (Example: DIGN)
1
Select Rgts/Cal from the menu bar.
2
Ensure the cal status of the chemistry DIGN is not "Requested." To cancel a calibration request:
• Select the position for the appropriate requested and assigned chemistry to be canceled.
• Select No Cal F8 to cancel the calibration request. Chemistries currently selected may be
canceled only if the calibration is not yet in progress.
3-6
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System Setup Options
Configuring the Chemistry Menu
3
Remove calibrator assignments. To clear calibrator bar code ID and/or rack and position:
• Select Assign F7.
• Select Next or Prev to locate the calibrator of interest.
OR
• Select the Calibrator Name pull-down menu at the top of the Assign Barcode/Rack dialog box
to view the List of Calibrators.
• To clear the fields select the Calibrator ID, Rack and Position fields for each level of calibrator
and press (Delete) on the keyboard.
• Select Close to exit and save information.
4
Remove the reagent cartridge. To remove the reagent cartridge DIGN:
• Select the position for the chemistry to be removed.
• Select Load F1.
• When prompted by the instrument to remove the reagent cartridge, open the reagent
carousel door to remove the cartridge. The reagent cartridge may be scanned off if it has a
bar code or select Clear F1 to remove reagent data.
• Close the reagent carousel door.
Remove the Chemistry from Sample Programming (Example: DIGN)
IMPORTANT All samples in the "sample required," "incomplete" and "rerun" status need to be cleared
before the chemistry can be deleted. Samples in the "in progress" or "removed" status should be allowed
to proceed to "complete" or "incomplete" status.
1
Request sample load lists for:
• Sample Required
• Incomplete and
• Rerun
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2
Select Samples from the menu bar.
3
Select List F9.
4
Select the Status field pull-down menu at the bottom of the Load List dialog box to view the List
of Sample Status.
5
Select Sample Required for a list of samples.
3-7
3
System Setup Options
Configuring the Chemistry Menu
6
Select Display to show the load list on the screen. The Load List may then be printed by selecting
Print to print, or OK to exit.
7
Repeat Steps 2–5 in this section to request load lists for samples in the Incomplete and Rerun
status. For Step 5:
• Select Incomplete for a list of samples.
• Select Rerun for a list of samples.
8
Look for the chemistry to be de-configured, DIGN, in each load list and clear these samples.
Refer to the UniCel DxC Synchron Clinical Systems Reference Manual, Clearing Samples section
for information on how to clear sample programming.
Remove the Chemistry from the Quality Control (QC) Program
If a control is defined solely for that chemistry and is no longer needed, the entire control definition
should be deleted.
1
Select QC from the menu bar.
2
Select the control to be cleared.
3
Select Delete F3.
4
The following message appears to confirm the clearing of the selected control:
"All QC files for the control will be deleted. Archiving is suggested. Delete this control?"
Select OK to delete the control.
5
3-8
If the control was deleted, type an operator ID of from 1–3 alphanumeric characters and press
(Enter) or (Tab) .
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System Setup Options
Configuring the Chemistry Menu
If the control definition contains the chemistry along with other chemistries that
should not be deleted, a single chemistry definition can be deleted.
1
Select QC from the menu bar.
2
From the QC screen, select a control number.
3
Select Define F2.
4
Select Chems F1. A list of configured chemistries appears.
• Remove the chemistry DIGN by deselecting the number next to the chemistry name.
• Press (Page Up) or (Page Down) keys to access all chemistries.
• Select OK to leave the selection screen and save the changes.
5
The following message appears to confirm the clearing of the selected chemistries from the
control: "QC data and statistics for this chemistry will be deleted. Archiving is suggested.
Deselect this chemistry?"
• Select OK to remove the chemistry from this control.
Deleting a Chemistry from the System (Example: DIGN)
1
Select Setup from the menu bar.
2
Select 2 Chemistry Configuration/Sample Type.
OR
Type 2 in the Option Number field and press (Enter) .
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3
Select Configured chemistry position number.
4
Select Delete F6.
3-9
3
System Setup Options
Configuring the Chemistry Menu
IMPORTANT Before de-configuring a chemistry, remove stored patient results containing that chemistry
from the system. To delete patient results, refer to CHAPTER 6, Sample Programming and Processing,
Clear Samples. If not, patient samples are purged during rollover at 10,000 Patient IDs or 150,000 results,
whichever comes first.
Beckman Coulter Defined Chemistries with Units and Precision
Table 3.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units
and Precision
Beckman Coulter Defined Chemistry
Acronym
Units
Precision
ACTM
μg/mL
X.X
Alanine Aminotransferase
ALT
IU/L
X
Alanine Aminotransferase (Pyridoxal-5'-Phosphate)
ALT-
IU/L
X
Albumin
ALB
g/dL
X.X
ALBm
g/dL
X.X
Alkaline Phosphatase
ALP
IU/L
X
Ammonia
AMM
μmol/L
X
Amphetamines
AMPH
mA/min
X.XX
Amylase
AMY
U/L
X
Antistreptolysin-O
ASO-
IU/mL
X.X
Apolipoprotein A-1
ApoA
mg/dL
X.X
Apolipoprotein B
ApoB
mg/dL
X.X
Aspartate Aminotransferase
AST
IU/L
X
Aspartate Aminotransferase (Pyridoxal-5'-Phosphate)
AST-
IU/L
X
Barbiturates
BARB
mA/min
X.XX
Benzodiazepine
BENZ
mA/min
X.XX
Benzodiazepine
BNZG
mA/min
X.XX
Calcium
CALC
mg/dL
X.X
Cannabinoid 100 ng
THC
mA/min
X.XX
Cannabinoid 20 ng
THC2
mA/min
X.XX
Cannabinoid 50 ng
THC5
mA/min
X.XX
Carbamazepine
CAR
μg/mL
X.X
Carbon Dioxide
CO2
mmol/L
X
CCWA
mA/min
X.XXX
CL
mmol/L
X
Cholesterol
CHOL
mg/dL
X
Cholinesterase
CHE
U/L
X
COCM
mA/min
X.XX
C3
mg/dL
X.X
Acetaminophen
Albumin (modular)
Cartridge Chemistry Wash Solution
Chloride
Cocaine Metabolite
Complement C3
3-10
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System Setup Options
Configuring the Chemistry Menu
Table 3.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units
and Precision (Continued)
Beckman Coulter Defined Chemistry
Acronym
Units
Precision
Complement C4
C4
mg/dL
X.X
C-Reactive Protein
CRP
mg/dL
X.X
C-Reactive Protein
C-RP
mg/dL
X.XX
C-Reactive Protein, High Sensitivity
CRPH
mg/dL
X.XXX
Creatine Kinase
CK
IU/L
X
Creatine Kinase (N-acetyl-L-Cysteine)
CK-
IU/L
X
Creatine Kinase-MB
CKMB
U/L
X.X
Creatinine
CREA
mg/dL
X.X
Creatinine
CR-S
mg/dL
X.XX
Creatinine (Serum/Plasma/Urine)
CREm
mg/dL
X.X
Direct Bilirubin
DBIL
mg/dL
X.X
Digoxin (Immuno Turbidimetric)
DIGN
ng/mL
X.X
Ethanol Alcohol
ETOH
mg/dL
X.X
Gamma (γ ) -Glutamyl Transferase
GGT
IU/L
X
Gentamicin
GEN
μg/mL
X.X
Glucose
GLU
mg/dL
X
Glucose
GLUCm
mg/dL
X
HPT
mg/dL
X
HDL Cholesterol (direct)
HDLD
mg/dL
X.X
Hemoglobin A1c
HbA1c
%
X.X
Hemoglobin A1c2
HbA1c2
%
X.X
Immunoglobulin A
Ig-A
mg/dL
X
Immunoglobulin G
Ig-G
mg/dL
X
Immunoglobulin M
Ig-M
mg/dL
X
Iron
FE
μg/dL
X
Lactate
LAC
mmol/L
X.X
Lactate Dehydrogenase
LD
IU/L
X
Lactate Dehydrogenase
LD-P
IU/L
X
LDL Cholesterol
LDLD
mg/dL
X.X
Lipase (random access)
LIP
U/L
X
Lithium
LI
mmol/L
X.XX
Magnesium
MG
mg/dL
X.XX
Methadone
METD
mA/min
X.XX
Methaqualone
METQ
mA/min
X.XX
Microalbumin
MA
mg/dL
X.X
Haptoglobin
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3
System Setup Options
Configuring the Chemistry Menu
Table 3.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units
and Precision (Continued)
Beckman Coulter Defined Chemistry
Acronym
Units
Precision
Microprotein
M-TP
mg/dL
X
Opiate (2000 ng/mL cutoff)
OP2
mA/min
X.XX
Opiate (300 ng/mL cutoff)
OP
mA/min
X.XX
Pancreatic Amylase
PAM
U/L
X
Phencyclidine
PCP
mA/min
X.XX
Phenobarbital
PHE
μg/mL
X.X
Phenytoin
PHY
μg/mL
X.X
PHOSm
mg/dL
X.X
PHS
mg/dL
X.X
Potassium
K
mmol/L
X.X
Prealbumin
PAB
mg/dL
X.X
PROX
mA/min
X.XX
RF
IU/mL
X.X
SALY
mg/dL
X.X
Sodium
NA
mmol/L
X
T-Uptake
TU
%
X.X
Theophylline
THE
μg/mL
X.X
Thyroxine
T4
μg/dL
X.X
Tobramycin
TOB
μg/mL
X.X
Total Bilirubin
TBIL
mg/dL
X.X
Total Iron Binding Capacity
IBCT
μg/dL
X
Total Protein (modular - CSF)
TPm
mg/dL
X
Total Protein (modular - Serum/Plasma)
TPm
g/dL
X.X
TP
g/dL
X.X
TRFN
mg/dL
X.X
TG
mg/dL
X
Triglycerides GPO Blanked
TG-B
mg/dL
X
Urea
UREA
mmol/L
X.X
Urea (modular)
UREAm
mmol/L
X.X
Urea Nitrogen
BUN
mg/dL
X
Urea Nitrogen (modular)
BUNm
mg/dL
X
Uric Acid
URIC
mg/dL
X.X
Valproic Acid
VPA
μg/mL
X.X
Vancomycin
VANC
μg/mL
X.X
Phosphorus (modular)
Phosphorus (Serum/Plasma/Urine)
Propoxyphene
Rheumatoid Factor
Salicylate
Total Protein (Serum/Plasma)
Transferrin
Triglycerides GPO
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System Setup Options
Setting the Default Sample Type
Setting the Default Sample Type
Introduction
Default Sample Type allows for definition of the default sample type for all programmed samples.
The sample type may be changed for individual samples while in the sample programming function.
Setup
To set the default sample type, select 2 Chemistry Configuration/Sample Type from the Setup screen.
Select the Default Sample Type pull-down menu at the top of the screen.
Date/Time Setup
Introduction
The Date/Time option allows the user to set the date and time, select the date/time formats that
appear on all screens and reports, and restore date and time defaults.
The first time the instrument is powered up, the user must set the date and time. When set, changes
to accommodate situations such as converting to daylight-savings time are performed through this
option. The Date/Time screen may be viewed at any time, but may only be modified when the system
status is Standby, Stopped, Startup, Instrument Down, or Homing.
Setup
To access Date/Time setup, from the Setup screen select 3 Date/Time. Then press Date F1 or Time F2
respectively to change the date and/or time formats for the system. Or you can press the Restore F3
key to restore the default display format.
Default Date Display Formats:
•
Order: mm dd yy
• Day Format: Leading Zero (01)
• Month Format: Leading Zero (01)
• Year Format: 1996 (four digit year)
• Separator: /
Default Time Display Formats:
• Time Format: 24 hour
• Hour Format: Leading Zero (01)
• Separator: :
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3
System Setup Options
Demographics Setup
IMPORTANT Changes to system date and/or time may affect reagent expiration date, calibration, quality
control data, within-lot calibration status, and on-board stability dates for reagents.
Demographics Setup
Introduction
The Demographics Setup option provides the ability to select the demographics fields that appear
in the demographics display/printout of the Program Samples function.
Setup
From the Setup screen, select 4 Demographics Setup to enable, disable and restore defaults to
demographic fields.
To change demographic field settings, the system must be in Standby, Stopped, Startup, Instrument
Down,or Homing.
The system default is ALL demographics fields shown.
Patient Results – Immediate Reporting Setup
Introduction
Use Immediate Report to configure the system to print and/or send results to the Host as they are
completed on the system. When these options are not selected, test results are not printed or sent
to the Host until all tests are completed for the sample ID.
Immediate Patient Results Reporting to Host and/or Printer
From the Setup screen, select 5 Immediate Report to change settings for Immediate Reporting.
To change Immediate Reporting settings, the system must be in Standby, Stopped, Startup,
Instrument Down, or Homing.
The default is all immediate reporting disabled (no boxes checked).
Select STAT in the Host section to send to the Host all MC chemistries programmed as STAT as soon
as they are completed. Select ALL in the Host section to send to the Host all MC chemistries as soon
as they are completed, whether or not they are programmed as STAT.
Select STAT in the Printer section to print all MC chemistries programmed as STAT as soon as they
are completed. Select ALL in the Printer section to print all MC chemistries as soon as they are
completed, whether or not they are programmed as STAT.
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A13914AF
System Setup Options
Panels
Select Immediate Report of Critical Rerun to send to the Host and/or printer any Critical Result
Rerun as soon as it is completed.
Select Immediate Report of Serum Index to send to the Host and/or printer any Serum Index result
as soon as it is completed.
Chemistries that are not complete at the time of interim STAT or ALL reports are designated by the
message Results Not Available in place of results. The report includes any results that are complete
at the time the report is generated. A final report with all results is printed upon completion of the
sample.
Panels
Introduction
The Panels option allows grouping of analytes commonly programmed and run together.
Defining, Editing and Deleting Panels
The operator may define a maximum of 50 panels, and must assign a unique name to each.
From the Setup screen, select 6 Panels to show the Panel Summary screen, then select Define F1 to
define, edit or Delete F2 to delete panels.
Panel definitions may be viewed and modified at any time.
Selecting a Default Panel
The operator may select one of the defined panels as the Default Panel. The DxC system selects the
Default Panel as the test(s) to run when the sample ID has no programming assigned, or after a Host
Query time-out.
From the Setup screen, select 6 Panels. From the resulting Panel Summary screen, select the panel
that you want to serve as the default and press Default F3. The ">" character shows to the left of the
selected Default Panel.
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3
System Setup Options
Replicates
Replicates
Introduction
The Replicates option allows the operator to set up the number of replicates per sample, which is
applied to all sample programs. The replicates per sample may also be edited by accessing a specific
sample program.
A maximum of 20 replicates may be assayed from a sample. All results are printed and maintained
in memory for recall.
Setup
From the Setup screen, select 7 Replicates to define the number of replicates or restore the system
Default Replicates value.
The Replicates option may be viewed at any time.
The system must be in Standby or Stopped state to change replicates.
The default for replicates is 1.
Report Setup
Introduction
This feature allows the operator to select the following options:
• Enable or disable printing of Patient and Control Reports
• Define a Report Header to print at the top of each report
• Select from a variety of Patient Report formats
• Select from a variety of Control Report formats
• Define Inter-Laboratory information to print in a report
Default settings:
• Facility Name: blank
• Facility Address: blank
• ID Number: blank
• Patient Report format: Lab Report
• Control Report format: Control Chart Report
3-16
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System Setup Options
Reportable Ranges Setup
Setup
From the Setup screen, select 8 Report Setup to make selections or changes to report setup
specifications.
Report Setup may be viewed at any time.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to edit Patient or
Control Report formats, Print Option, or the Inter-Laboratory information.
Reportable Ranges Setup
Introduction
The three types of range limits that can be applied to each analyte are:
• Analytical Range
• Instrument Printable Range
• Reportable Range
Analytical Range
The Analytical Range is an internal system limit verified by Beckman Coulter.
Refer to the Synchron Clinical Systems Chemistry Information Manual and the Synchron Clinical
Systems Chemistry Reference Manual for Analytical Ranges by analyte.
Instrument Printable Range
The Instrument Printable Range is an internal system limit, specified in the Reportable Range Setup
screen. The Instrument Printable range exceeds the Analytical Ranges by a factor. This allows for
the printing/reporting of a result slightly above or below the Analytical Range, given small
precision variations. A result outside of the Instrument Printable Range is suppressed. The
suppressed results are flagged OIR HI or OIR LO (Out of Instrument Range).
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3
System Setup Options
Reportable Ranges Setup
Reportable Range
The Reportable Range is operator-defined and represents the range verified at the operator’s site.
The Reportable Range may or may not be the same as the Analytical Range. A result exceeding the
Reportable Range is flagged ORR HI or ORR LO (Out of Reportable Range).
The Reportable Range feature is available on all configured chemistries except drugs of abuse (DAT)
and Beckman Coulter Performance Verification Tests (PVT).
The Reportable Range feature is available for User Defined Reagents (UDR). When any UDR
parameter is edited, the instrument automatically changes the Reportable Range information to the
Usable Range defined for the UDR. The Reportable Range must be re-entered if the values are
different from the Usable Range.
NOTE You cannot evaluate QC by Reportable Range. QC will not suppress or flag results based on Reportable
Range.
Suppress Results Option
For each analyte and sample type, the operator may enable or disable the Suppress Results option.
Results exceeding the Reportable Range are always flagged. If the Suppress Results check box is not
checked, the result number is printed on the report and sent to the LIS along with the remark. When
the Suppress Results check box is checked, instead of a numeric result the report will show Result
Suppressed and the numeric result is not sent to the LIS.
The Suppress Result option is not available for any chemistry that can report a less-than (<) or
greater-than (>) result. They are ACTM, CRP, PHE, TOB, ASO-, CRPH, PHY, VANC, C3, C-RP, RF, VPA,
C4, DIGN, SALY, CAR, GEN and THE.
The default for a Reportable Range is the Printable Range.
The default for Suppress Results is OFF (box is not checked).
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to edit these ranges.
From the Setup screen, select 9 Reportable Ranges to define, edit, or suppress a reportable result.
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A13914AF
System Setup Options
Reference/Critical Ranges Setup
Reference/Critical Ranges Setup
Reference and Critical Ranges
Reference and Critical Range Setup options allow the operator to define the reference and critical
ranges for each analyte by age group, gender and sample type. Up to 32 age ranges may be defined.
In addition, the operator may select one reference range as the default.
Each facility should establish reference ranges based on its own population demographics.
The Critical Range limits are used in conjunction with the Critical Results Rerun option. When the
limits of the critical range defined by the operator are exceeded, the system automatically reruns
the analyte. The operator may delete one result or send both to the host.
The Critical Results Rerun option should not be enabled for analytes with POS or NEG result reports
such as the drug of abuse tests (DAT).
From the Setup screen, select 10 Reference/Critical Ranges to define, edit, delete, view or set a
default.
Reference and Critical Ranges may be viewed while the system is running
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to edit these ranges or
to enable/disable Critical Results Rerun.
Sample Comments Setup
Introduction
The Sample Comments option allows the operator to define a maximum of 20 comments for use in
the Sample Programming screen.
Setup
From the Setup screen, select 11 Sample Comments to define, edit or delete sample comments. Up
to 25 alphanumeric characters, including spaces and punctuation, are allowed.
Sample Comments may be modified at any time.
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3
System Setup Options
Special Calculations Definition
Special Calculations Definition
Introduction
The two types of Special Calculations that can be reported with a sample are:
• Predefined by Beckman Coulter
• Operator defined
The system can maintain up to 40 special calculations. You can enable or disable the predefined
special calculations, but you cannot modify or delete them from the system. You can define and
modify additional special calculations.
When a special calculation is enabled, the value is reported only if the appropriate chemistries for
the equation are programmed and run for a given sample ID.
The system uses the full precision of the test’s results when performing special calculations. If you
manually calculate, using results that have been rounded, the results will be similar but they will
not match exactly.
From the Setup screen, select 12 Special Calculation to define, edit, delete or view a special
calculation.
Special Calculations may be viewed at any time.
The system must be in Standby or Stopped to define, edit or delete operator-defined Special
Calculations or to enable/disable them.
The default for any Special Calculation is disabled.
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A13914AF
System Setup Options
Special Calculations Definition
Beckman Coulter Predefined Special Calculations Defaults
Table 3.2 Beckman Coulter Predefined Special Calculations Defaults
Calculation
Unit
Precision
Sample Type
Osmolality (1)
mOsm/L
X.X
Serum
Osmolality (2)
mOsm/L
X.X
Serum
Anion Gap (1)
mmol/L
X.X
Serum
Anion Gap (2)
mmol/L
X.X
Serum
A/G Ratio
None
X.X
Serum
Indirect Bilirubin
mg/dL
X.X
Serum
BUN/CREA Ratio
None
X.X
Serum
Urea/CREA Ratio
None
X.X
Serum
Free Thyroxine
None
X.X
Serum
CREA Clearance (1)
mL/min
X.X
Timed Urine
CREA Clearance (2)
mL/sec
X.X
Timed Urine
ApoA/ApoB Ratio
None
X.X
Serum
ApoB/ApoA Ratio
None
X.X
Serum
Hemoglobin A1c
%
X.X
Serum
Hemoglobin A1c2
%
X.X
Blood
Hemoglobin A1c SI
mmol/mol
X.X
Serum
Hemoglobin A1c2 SI
mmol/mol
X.X
Blood
Beckman Coulter Predefined Special Calculation Formulas
Table 3.3 UniCel DxC 600 Predefined Special Calculation Formulas
Calculation
A13914AF
Formula
Osmolality (1)
(1.86 × NA) + (GLUCm/18) + (BUN/2.8) + 9
Osmolality (2)
(1.86 × NA) + (GLUCm/18) + (UREA) + 9
Anion Gap (1)a
NA - (CL + CO2)
Anion Gap (2)a
(NA + K) - (CL + CO2)
A/G Ratio
ALB / (TP - ALB)
Indirect Bili
TBIL - DBIL
BUN/CREA Ratio
BUN/CREA
UREA/CREA Ratio
UREA/(CREA × 0.0884)
Free Thyroxine
T4 × (TU/0.342)
CREA Clearance (1)
[(U × V)/P] × (1.73/A) reported in mL/min
CREA Clearance (2)
[(U × V)/P] × (1.73/A) reported in mL/sec
3-21
3
System Setup Options
Special Calculations Definition
Table 3.3 UniCel DxC 600 Predefined Special Calculation Formulas (Continued)
Calculation
Formula
ApoA/ApoB Ratio
ApoA/ApoB
ApoB/ApoA Ratio
ApoB/ApoA
HbA1c
A1c/Hb × 100
HbA1c2
A1c2/Hb2 × 100
HbA1c SI
A1c/Hb x 1000
HbA1c2 SI
A1c2/Hb2 x 1000
a. For a review of anion gap please refer to: Kraut JA, Madias NE: Serum anion gap: its uses and limitations in clinical
medicine. Clin J Am Soc Nephrol. 2007 Jan;2(1):162-74
Table 3.4 UniCel DxC 800 Predefined Special Calculation Formulas
Calculation
Formula
Osmolality (1)
(1.86 × NA) + (GLUCm/18) + (BUNm/2.8) + 9
Osmolality (2)
(1.86 × NA) + (GLUCm/18) + (UREAm) + 9
Anion Gap (1)a
NA - (CL + CO2)
Anion Gap (2)a
(NA + K) - (CL + CO2)
A/G Ratio
ALBm / (TPm - ALBm)
Indirect Bili
TBIL - DBIL
BUN/CREA Ratio
BUNm/CREm
UREA/CREA Ratio
UREAm/(CREm × 0.0884)
Free Thyroxine
T4 × (TU/0.342)
CREA Clearance (1)
[(U × V)/P] × (1.73/A) reported in mL/min
CREA Clearance (2)
[(U × V)/P] × (1.73/A) reported in mL/sec
ApoA/ApoB Ratio
ApoA/ApoB
ApoB/ApoA Ratio
ApoB/ApoA
HbA1c
A1c/Hb × 100
HbA1c2
A1c2/Hb2 × 100
HbA1c SI
A1c/Hb x 1000
HbA1c2 SI
A1c2/Hb2 x 1000
a. For a review of anion gap please refer to: Kraut JA, Madias NE: Serum anion gap: its uses and limitations in clinical
medicine. Clin J Am Soc Nephrol. 2007 Jan;2(1):162-74
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A13914AF
System Setup Options
Timed Urine and Creatinine Clearance Results
Timed Urine and Creatinine Clearance Results
Introduction
When Timed Urine is designated as the sample type for a Sample ID, the Results report will reflect:
• the concentration of the sample aliquot placed on the instrument.
• the concentration of the analyte with respect to sample volume and collection time period.
The DxC 600/800 performs additional calculations to accurately report the concentration as a
function of volume and time.
Calculation Constants and Factors
The sample volume is always expressed in milliliters (mL).
The selectable units for any given chemistry are always expressed as weight per milliliter
(therapeutic drugs only and this would be extremely rare), deciliter or liter.
Therefore, the factors applied to total volume will only be as follows:
• milliliters to milliliters = 1.0
• milliliters to deciliters = 0.01
• milliliters to liters = 0.001
For examples of Timed Urine Calculations, refer to the UniCel DxC Synchron Clinical Systems
Reference Manual, CHAPTER 3, Detailed System Setup.
Version Information
Introduction
The Version Information screen provides a condensed reference to:
• the software version number.
• the chemistry database version.
The Version Information screen may be viewed at any time.
Setup
From the Setup screen, select 13 Version Information, to review the Version Information.
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3
System Setup Options
Units/Precision Setup
Units/Precision Setup
Introduction
The Units/Precision option allows the operator to select the units and number of decimal places for
each viewed and printed result.
When the units are altered, all features affected by the change, such as reference ranges and
calibration values, automatically convert to match the new units.
Units cannot be changed for chemistries that are defined for a control in QC.
Setup
From the Setup screen, select 14 Units/Precision to modify units and number of decimal places or to
restore defaults.
The Unit Selection/Precision may be viewed at any time.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to change unit
selection or decimal places.
Refer to the default chemistry units and precision in Table 3.1.
User Defined Chemistries Setup
Introduction
With User Defined Chemistries, a maximum of 100 chemistries may be defined on the UniCel DxC.
Setup
Select 15 User-Defined Chemistries from the Setup screen.
For detailed information about User Defined chemistries, refer to CHAPTER 8, User Defined Reagents
in this manual.
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System Setup Options
Bar Code Setup
Bar Code Setup
Introduction
The Bar Code Setup option allows the operator to:
• Enable/disable sample bar code mode of operation
• Enable/disable sample bar code types
• Configure sample bar code parameters
• Restore defaults
The four sample bar code types that may be used on the DxC are:
• Code 39
• Codabar
• Interleaved 2 of 5
• Code 128
Any combination of bar code types may be enabled.
Setup
From the Setup screen, select 16 Bar Code to enable/disable bar code types, to further define bar
code parameters or to restore defaults
Bar Code Setup may be viewed at any time.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to make modifications.
Bar Code Setup Defaults:
• Bar Code mode: Enabled
• All bar code symbologies: Enabled
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3
System Setup Options
Maximum Sample Program Age
Maximum Sample Program Age
Introduction
This feature refers to the age of the sample program. The operator may define the time limit
allowed before the same sample ID can be reloaded on the system. The operator is notified of the
time conflict by a pop-up window when the time limit has been exceeded.
This feature is useful when Sample IDs are reused regularly.
Setup
From the Setup screen, select 16 Bar Code and check the box beside "Maximum Sample Program
Age" to enable this feature. The operator can enter the time limit in hours or days.
The system must be in Standby or Stopped to make changes.
The default is disabled.
Reserved Racks/Obstruct Detect
Introduction
The Reserved Rack/Obstruction Detection option allows the operator to:
• Enable/disable the CTS (Cap Piercer) option.
• Enable/disable obstruction detection.
• Assign reserved rack numbers for small sample volume containers.
• Reserve a rack number or numbers for the analysis of HbA1c or IBCT samples.
• For a CTS system, assign rack numbers to the proper rack size.
• Restore defaults.
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A13914AF
System Setup Options
Disable Service Monitor
Setup
From the Setup screen, scroll down and select 17 Reserved Racks/Obstruction Detection to enable/
disable CTS, enable/disable obstruction detection, assign reserved rack numbers for small sample
volume containers, HbA1c or IBCT, or to restore defaults.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to make modifications.
When changing the CTS option, the operator must Stop and Home the system to completely enable
the feature.
Defaults:
• CTS: Off
• Obstruction Detection: On
• Reserved Racks: None Reserved
• Reserved Racks for HbA1c or IBCT: None Reserved
Disable Service Monitor
Introduction
The Disable Service Monitor option permits the service monitor to be disabled.
When the Metering Counter is activated, the Service Monitor must be disabled. Refer to the Synchron
Clinical Systems Metered-Use Manual for information regarding the metering option.
Setup
The system must be in Standby or Stopped to change this option.
From the Setup screen, scroll down and select 18 Disable Service Monitor.
The default is Disabled.
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3
System Setup Options
Host Communications
Host Communications
Introduction
Table 3.5 following lists the Host communications parameters, the options of each, and the default
values.
Table 3.5 DxC Host Communications Parameter Options for ASTM, LX20/DxC, CX7 Compatible
Parameter
Serial Options
Transport
TCP/IP Options
Serial or TCP/IP
Default
Serial
IP Address
NAa
NNN.NNN.NNN.NNN
Blank
Port #
NA
Up to 5 digits
Range: 0–65535
12003
Data Bits
7 or 8
NA
8b
Stop Bits
1 or 2
NA
1b
ASTM Header
3 Digit Rack Number
Device ID
Short or Long
Short
Selected or Not Selected (CX7 Compatible only)
Not Selected
0–99
0
Flow Control
Software (XON/XOFF),
Hardware (RTS/CTS)c
or none
Data Transmission Mode
Transmission OFF, Unidirectional, Bidirectional
or Bidirectional with Query
Bidirectional
CX7 Compatible
LX20
ASTM
CX7 Compatible
Interface
NA
Software (XON/XOFF)
Parity
None, Odd or Even
NA
Noneb
Baud Rate
300, 1200, 2400,
4800, 9600, 19200
NA
9600
Query Timeout
2½, 4 or 6 minutes
2½ minutes
Requery
(Automatic Requery of Host)
Selected or Not Selected
Not Selected
Query Terminator
Selected or Not Selected
Selected
Host does NOT accept either
< or > symbols
Selected
< or > symbols
a. NA=Not Applicable
b. For Data Bits, Stop Bits and Parity, the Default Options are recommended settings when serial transport is selected.
c. For Flow Control, do not select the Hardware (RTS/CTS) option. With the Hardware option, ESD interference may affect the
performance.
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A13914AF
System Setup Options
Language/Keyboard Setup
Setup
From the Setup screen, scroll down and select 20 Host Communications to select parameters or
restore defaults.
The system must be in Standby or Stopped to make modifications.
Refer to the UniCel DxC Synchron Clinical Systems Host Interface Specifications for comprehensive
documentation for the host parameters.
Language/Keyboard Setup
Introduction
The Language/Keyboard Setup option allows the operator to select from the following languages
and keyboards for instrument operation:
• English
• French
• German
• Italian
• Spanish
• Japanese
• Simplified Chinese
Setup
From the Setup screen, scroll down and select 21 Language/Keyboard to select and activate the
desired language or keyboard.
Changing from Japanese to any other language or keyboard will require a reloading of the operating
software.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to make modifications.
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3
System Setup Options
Printer Setup
Printer Setup
Introduction
The Printer Setup option allows selection of paper size.
Setup
From the Setup screen, scroll down and select 22 Printer Setup to select one of three paper sizes.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to make modifications.
The default paper size is U. S. Domestic (8 ½ × 11 inches).
For laser printers use laser printer quality paper.
Service Setup
Introduction
The Service Setup feature allows Beckman Coulter support personnel to access several service
features on the system. Entering into this area activates the Service Monitor mode of operation.
Other than being able to access the protected features in this area and in the way tests are counted,
if on a metered reagent plan, there is no difference in system operation while in this mode. While
using the Service Setup feature, the menu bar is green. After exiting from Service Setup the screen
returns to normal.
Enabling Service Setup
This feature is password protected and can only be accessed by Beckman Coulter personnel.
Disabling Service Setup
The Service Monitor mode can be disabled at any time. Refer to Disable Service Monitor in this
chapter for instructions.
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System Setup Options
System Configuration
System Configuration
Introduction
Changes in hardware configuration may require changes to the (1) data logger IP address and/or (2)
the hardware Ethernet address. This feature allows changes to be made to both areas. If changes
are necessary, the new information is supplied by Beckman Coulter.
The instrument serial number is also shown in this area.
View/Edit System Configuration
This feature is password protected and can only be accessed by Beckman Coulter personnel.
CAUTION
Changes to the information in this area should only be done at the request or at
the direction of Beckman Coulter, Inc. Entry of incorrect information will lead to
system errors.
Version Upgrade
Introduction
The Version Upgrade option allows the operator to load a new version of operating software onto
the system.
Setup
From the Setup screen, scroll down and select 25 Version Upgrade to load an upgrade to operating
software.
The system must be in Standby or Stopped state to load new software. Never turn off power to the
system or console while loading software.
Please refer to the UniCel DxC Software Installation Procedure shipped with the CD-ROM.
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3
System Setup Options
Status Alarm/Annunciator
Status Alarm/Annunciator
Introduction
The Status Alarm/Annunciator option allows the operator to:
• Select from 5 different audible alarm patterns
• Test the audible alarm
• Disable the audible alarm
Setup
From the Setup screen, scroll down and select 26 Status Alarm/Annunciator to select an alarm
pattern, test or disable the alarm.
The system default is NO ALARM.
Changes to the alarm may be made at any time.
Although the system will continue providing pop-up notes requiring operator attention, disabling
the alarm will not sound an audible alert.
Chemistry Update
Introduction
The Chemistry Update option allows the operator to load a new version of chemistry database
software that:
• Updates chemistries on the existing menu
• Adds new chemistries
Setup
From the Setup screen, scroll down and select 27 Chem Update to load a new version of chemistry
database software.
The system must be in Standby or Stopped state to load new software. Never turn off power to the
system or console while loading software.
Please refer to the UniCel DxC Software Installation Procedure shipped with the CD-ROM.
IMPORTANT During the update, never turn off the power to the system or the console.
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System Setup Options
Auto Generation of Control
Auto Generation of Control
Introduction
When this feature is enabled, if a sample is loaded with a defined control ID, the instrument will
automatically run any chemistry that is on-board and runnable for that control.
When Auto Generation of Control is enabled, the automatic Multiple Cartridge option is available.
With the Multiple Cartridge option enabled, the system automatically runs all cartridges on-board
and runnable for any chemistries for an Auto Generated control. Enabling Multiple Cartridge
without Auto Generation has no effect on the manual programming of control samples.
Setup
From the Setup screen, scroll down and select 29 Auto Generation of Control to enable/disable either
feature.
The system must be in Standby, Stopped, Startup, Instrument Down, or Homing to make modifications.
The default is disabled.
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3
System Setup Options
Auto Generation of Control
3-34
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CHAPTER 4
Reagent Load/Calibration
Reagent Load
Introduction
This chapter describes how to load reagents onto the DxC 800 and DxC 600 systems and calibrate
chemistries using the Reagent Load/Calibration screen. The DxC system loads and removes both
cartridge (CC) and modular (MC) chemistries bulk reagents. Reagent information encoded on the
container label can be read by the bar code reader or entered manually from the keyboard.
Cartridge reagents:
• are stored in wedge-shaped cartridges containing three separate compartments.
• include a majority of chemistries (excluding the electrolytes).
• include user-defined reagents.
Modular reagents:
• Modular reagents are stored inside the lower left compartment in either 500 mL, 1 L, or 2 L
bottles.
• Other solutions associated with modular reagents include:
— No Foam
— CTS Auto-Gloss (used to lubricate CTS blade)
— Wash Concentrate II
— Alkaline Buffer
No Foam, CTS Auto-Gloss, and Wash Concentrate II are stored in bottles in the center
Hydropneumatics compartment. The Alkaline Buffer is stored in a bottle within the ISE Module.
Always check reagent status before starting a run. Make sure reagent is loaded for all tests ordered
and that all reagents have sufficient volume to complete the number of tests in the run.
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Reagent Load/Calibration
Reagent Load
Pre-Run Checklist
Before testing samples, generate a Pre-Run Checklist to determine if reagents should be loaded or
calibrated. From the Main screen, select Pre-Run F9 or select Rgts/Cal. Select Print F10.
Rgts/Cal Screen Overview
If the Rgts/Cal icon is red or yellow, select it and look for chemistries that are highlighted red or
yellow. Refer to Figure 4.1. Red highlighted chemistries will not run. Yellow highlighted chemistries
will run, but check the reagent volume before starting. Load new reagent if the reagent volume is
insufficient to run pending tests.
Figure 4.1 Reagent Load/Calibration Screen
E016483S.EPS
Load requests can be made simultaneously or independently for the MC and CC sides of the
instrument. To load MC reagents the system must be in Standby. CC reagents can be loaded while
the system status is in Standby or Running. The system automatically senses the level of reagent in
all the cartridges. Reagent status messages are listed in Table 4.1.
Table 4.1 Reagent Status Messages
Message
4-2
Explanation
Load Requested
Reagent position has been requested for reagent load but the system is
running.
Parameters Required
Parameters for a reagent cartridge are missing and were not loaded when
the cartridge was loaded.
Reagent Ok
No error flags present.
Reagent Expired
Reagent has exceeded shelf life stability date.
Days Exceeded
Reagent has been on system longer than acceptable.
0 Tests Available
Reagent has been used completely; reagent cartridge is empty.
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Reagent Load/Calibration
Reagent Load
Table 4.1 Reagent Status Messages (Continued)
Message
Explanation
Level Pending
Reagent cartridge has been loaded and is waiting to be level-sensed.
Level Sense Error
Level sense check failed to properly detect reagent in one or more
compartments.
n/a
Reagent status is not applicable for this chemistry (for example, an
electrolyte chemistry).
Sort Reagent Status
The order in which CC reagents are shown on the Reagent Status/Calibration Status screen can vary
according to operator selection.
1
Select Rgts/Cal from the menu bar.
2
Press (Page Up) or (Page Down) to go to pages 3–8.
3
Select Sort F9. A dialog box appears.
4
Select the sorting option in which the CC Chems should be shown.
• Position (on reagent carousel).
• Chemistry (Lists CC Chems alphabetically. The oldest cartridge is listed on top, for multiple
carts of the same Chem.)
• Days Left (onboard stability or expiration date, whichever comes first).
• Tests Left (number of tests left in cartridge).
• Cal Time Left (oldest Cal date listed first).
NOTE The option selected is shown in ascending or alphabetical order. When the sorting option is
selected, the sorting order is retained until the operator changes it.
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4-3
4
Reagent Load/Calibration
Reagent Load
Load/Unload Reagent
MC Reagents Information
The DxC System loads and unloads Modular Chemistries (MC) using the bar code system. The
reagent bar code information includes:
• Serial Number
• Lot Number
• Expiration Date
• Reagent Name
Figure 4.2 MC Reagent Information
1
4
2
3
A015919P.EPS
1.
2.
3.
4.
Reagent Name
Lot Number
Expiration Date
Serial Number
Reagent information is encoded on the label and read by the bar code reader when the reagent is
loaded or unloaded from the system. This information makes each container unique and allows the
DxC to maintain an accurate inventory of MC reagents.
Modular Chemistry (MC) Reagents
The Modular Chemistries (MC) reagents are stored in either 500 mL, 1 L, or 2 L bottles. Refer to
Figures 4.3, 4.4 and 4.5.
4-4
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Reagent Load/Calibration
Reagent Load
Figure 4.3 DxC 800 Leftmost Compartment
1.
2.
3.
4.
5.
BUNm/UREAm
PHOSm
GLUCm
TPm
ALBm
6.
7.
8.
9.
CREm
Electrolyte Buffer
Electrolyte Reference
CO2 Acid
Figure 4.4 DxC 600 Leftmost Compartment
1. GLUCm
2. CO2 Acid
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3. Electrolyte Buffer
4. Electrolyte Reference
4-5
4
Reagent Load/Calibration
Reagent Load
Figure 4.5 DxC 600/800 Center Compartment
3
2
1
A015922P.EPS
1. Wash Concentrate II
2. No Foam solution
3. CTS Auto-Gloss
Modular chemistry reagent bottles are selected from the Rgts/Cal screen and replaced as necessary
according to volume. Reagent volume levels are automatically tracked by the system after the initial
volume is set. When a new reagent bottle is replaced the system assumes the bottle is 100% full. If
the new bottle is not 100% full, the volume may be adjusted.
Load/Unload Modular Chemistries (MC)
4-6
1
Select Rgts/Cal from the menu bar.
2
Select the MC Rgts (Modular Chemistries).
3
Select Load F1.
4
Open the leftmost and/or center doors to access modular reagents. Refer to Figure 4.3 or
Figure 4.4, and Figure 4.5.
5
Remove the reagent from the system. It is not necessary to scan the bar code of the reagent
bottle when removing it.
6
Place new bottle on the system.
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Reagent Load/Calibration
Reagent Load
CAUTION
To avoid contamination, do NOT touch the reagent straw.
NOTE The No Foam container shown in Figure 4.6 (2) is refilled by pouring a fresh bottle of No Foam
solution into the empty container on the instrument.
Refer to Figure 4.6 and refill the No Foam container as follows:
• Wipe dust from around cap (4).
• Vent the No Foam container (2) by disconnecting the quick connector (3) at side of
container.
NOTE The connector may be located on either side of the No Foam container.
• Using the No Foam Container Cap Wrench, loosen the cap (4) from top of lid (1) by turning
the wrench counterclockwise.
NOTE Make sure the wrench is flush with the No Foam cap.
• Using the hand-held bar code reader, scan the bar code on new No Foam bottle.
• Pour bottle contents into No Foam container (2).
• Wipe off any spillage.
• Replace cap (4) and hand tighten. Do not use the wrench to tighten the cap.
• Reattach connector (3).
Figure 4.6 No Foam Container (DxC 800 shown)
4
1
3
2
A016484P.PNG
1. Lid
2. No Foam Container
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3. Connector
4. Cap
4-7
4
Reagent Load/Calibration
Reagent Load
7
Use the hand-held bar code reader to scan the reagent bar code of each new bottle. The system
"beeps" to indicate a successful bar code read.
Check the monitor to verify that the reagent data shows. When the bar code is scanned, the
reagent screen updates with current reagent information. The reagent may be loaded manually,
if the bar code cannot be scanned. If the bar code can not be scanned, manually clear the
reagent by selecting Clear F1, type new information.
8
Close the door and select Done F10. For loaded chemistries, continue to Step 9.
9
For loaded chemistries, calibrate and run QC before processing patient samples.
CC Reagents Information
DxC Systems use the cartridge bar code to identify and record data regarding reagent name, lot
number, expiration date (for example, 200601), and serial number of the cartridge. Refer to
Figure 4.7 and Figure 4.8. Additionally, the system retains calibration status of loaded and unloaded
cartridges.
• Reagents can be loaded while the system is Running or in Standby.
• Check reagent box or Reagent Preparation Card for reagent preparation instructions.
• Caps must be removed from the cartridge before loading.
• Check cartridges for bubbles in the reagent compartments before loading. Use an applicator
stick to remove bubbles.
Figure 4.7 CC Reagent Information
3
2
1
4
A016485P.EPS
1. Reagent Name
2. Lot Number
4-8
3. Expiration Date
4. Serial Number
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Reagent Load/Calibration
Reagent Load
Figure 4.8 CC Reagent Information
1. Reagent Name
2. Lot Number
3. Expiration Date
4. Serial Number
Load/Unload Cartridge Chemistries (CC)
1
Select Rgts/Cal from the menu bar.
2
Select all positions to be loaded or unloaded. The selected positions are highlighted. Use the up
and down arrows to access screens for additional chemistries.
3
Select Load F1.
4
To unload reagent:
• When the screen prompts you to remove the cartridge (1), open the reagent carousel door.
The cartridge to unload is positioned on either the upper or lower reagent carousel. A
blinking bar code reader indicates which carousel position to unload from the upper and
lower reagent carousel. Top positions (2) are 31 to 59. Bottom positions (3) are 1 to 30. Grasp
the cartridge at top and bottom, lift up a little and pull back. Refer to Figure 4.9.
• As the cartridge is moved in front of the bar code reader, a beep will indicate that the bar
code is read. Check the screen to verify reagent data is removed from the position selected.
If the bar code does not read, manually clear the position. To manually clear, select Clear F1.
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4-9
4
Reagent Load/Calibration
Reagent Load
Figure 4.9 Reagent Carousel
2
3
1
A011871P.EPS
1. Cartridge
2. Top Positions
3. Bottom Positions
5
To load reagent:
• When the screen prompts you to load the cartridge, open the reagent carousel door. Move
the cartridge in front of the bar code reader. A beep will indicate that the bar code is read.
• Check the screen to verify reagent data is added to the selected position. If the bar code
does not scan, manually type the information.
6
Close the reagent carousel door.
7
If multiple positions are selected to load or unload, repeat Step 4-6.
8
Before processing samples, calibrate and run QC if needed.
Reagent Parameters
Calibration parameters specific for a particular reagent lot are included with certain multipoint,
non-linear reagent cartridges. These parameters are referred to as Reagent Lot Specific Parameters.
The Reagent Lot Specific Parameters, contained in four bar codes, are included on a card in the
Reagent Kit.
These parameters:
• are loaded as part of a reagent load whenever the parameters are not found in the database.
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Reagent Load/Calibration
Reagent Load
• can be loaded using the hand-held bar code reader or loaded manually.
Load Reagent Parameters
1
Select Rgts/Cal from the menu bar.
NOTE If parameters are loaded as part of the reagent cartridge load, proceed directly to Step 3.
2
Select Params F2.
NOTE Parameters cannot be loaded if the reagent cartridge is onboard and the system status is
Running.
3
After the reagent cartridge loads successfully, a Load Reagent Parameters dialog box appears.
Enter data for cartridges that require parameter entry.
To automatically load reagent parameters:
• Use the hand-held bar code reader to scan each of the four bar codes.
• The blue bar indicator on the number button indicates the parameter was scanned
successfully.
Unacceptable bar codes are not read and a message appears.
4
To manually load reagent parameters:
• Type the parameter information, from the parameter card, on each line of the Load Reagent
Parameters dialog box.
NOTE Readable parameters coincide with each bar code on the card.
• The blue bar indicator on the number button indicates the parameter was entered
successfully.
5
Select Done to exit and save information.
OR
Select Clear to delete information.
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4
Reagent Load/Calibration
System Calibration
System Calibration
Introduction
System calibration is used to standardize the analysis of samples to existing conditions. Refer to the
Synchron Clinical Systems Chemistry Information Manual for detailed information regarding such
conditions. In general, system calibration is required when:
• A new Cartridge Chemistry (CC) reagent cartridge is used (except when within lot calibration
applies).
• A new Modular Chemistry (MC) reagent is loaded.
• At recommended calibration frequency intervals.
• Indicated by control results.
• Defined per your laboratory policy.
• Electronic or module adjustment is performed.
• A Calibration set point is modified.
• Specific maintenance procedures as defined in CHAPTER 9, Maintenance of this manual are
performed.
Calibration options are identified in the Cal Options box. To access a cal option, select Options F6
from the Reagent Status screen as shown in Figure 4.1. Then select the pull-down menu in the Cal
Options box to select the desired cal option. The cal options are:
• Load calibrator diskettes
• Calibrator acceptance limits
• Modify set points
• Slope/offset adjustment
• Within lot calibration
• Enzyme validator
• Calibration override
• Bypass chemistry
• Extend calibration time
• Print cal report
Load a Calibrator Diskette
Serum based calibrators require a calibrator diskette to be loaded on the system. The calibrator
diskette is loaded only one time per lot number.
• To check what lot number is currently loaded on the system, select the Rgts/Cal icon from the
menu bar, then select Options F6. Use the pull-down menu to select “Calibrator Acceptance
4-12
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Reagent Load/Calibration
Calibrator Assignment
Limits.” To find the calibrator, use either the Prev and Next button or use the pull-down menu
and select the calibrator name.
• To load a new lot number of calibrator, locate the calibrator diskette in the calibrator box and
follow the procedure below.
1
Make sure the DxC is in Standby.
2
Select Rgts/Cal from the menu bar.
3
Select Options F6.
4
Select Load calibrator diskette.
5
Verify that the lot number on the diskette is the same as the lot number on the calibrator bottle.
Insert the diskette into the disk drive. Select OK.
6
Verify that the lot number on the screen is the same as the lot number on the calibrator bottle.
7
Remove the diskette from the disk drive.
• If no other diskettes are to be loaded,
— Select Cancel.
• If additional calibrator diskettes need to be loaded,
— Select OK and repeat Step 5.
• If the incorrect diskette was placed in the disk drive
— Select OK.
— Obtain the correct diskette.
— Go back to Step 5.
Calibrator Assignment
To calibrate a reagent, first assign the rack/position or calibrator ID. The assignments can be reused
or new assignments can be programmed with each new calibration.
NOTE A reserved rack must be used when placing a calibrator cup in a tube.
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4-13
4
Reagent Load/Calibration
Calibration Status
1
Select Rgts/Cal from the menu bar.
2
Select Assign F7.
3
Use the down arrow option button to open list of calibrators.
4
Select the calibrator.
5
Enter the ID of the calibrator or the rack/position number.
• If using a bar code label, the label must match the assigned calibrator ID.
• If a rack/position is assigned, the calibrator must be placed in this assigned position.
6
Repeat Steps 3–5 to assign additional calibrators.
7
When calibration assignment is complete, select Close.
Calibration Status
Introduction
Calibration status, as well as reagent status, is accessed from the Rgts/Cal dialog box. Calibration
status is shown to determine which chemistries require calibration.
Calibration Status Messages
Table 4.2 Calibration Status Messages
Message
4-14
Explanation
Requested
Indicates that calibration is pending and calibrators have been identified.
Calibrated
Indicates that the chemistry has been calibrated and has not exceeded its
calibration time period.
Cal Required
Appears when:
• a new cartridge is loaded.
• a user-defined cartridge is loaded.
• a non-overrideable calibration failure has occurred.
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Reagent Load/Calibration
Reagent and Calibration Status Warnings
Table 4.2 Calibration Status Messages (Continued)
Message
Explanation
Cal Overridden
Operator-initiated; results are based on the failed calibration.
Chem Bypassed
Operator-initiated; allows analysis to proceed on all other chemistries without
having to deprogram the bypassed chemistry. A bypassed chemistry can be
recalibrated, but not extended or overridden.
Cal Failed
Indicates that calibrator values for a chemistry have exceeded calibration
acceptance limits.
Cal Timed Out
Indicates time remaining has exceeded the recommended calibration period.
Cal Time Extended
Operator-initiated; indicates that the recommended calibration period has been
extended. The chemistry must have a valid current calibration to be extended.
Within-Lot Pending
Indicates calibration has been requested for another cartridge with the same lot
number. Applies only to chemistries with within-lot capability.
Disable
System-initiated or operator-initiated; allows analysis to proceed on all other
chemistries without having to deprogram the disabled chemistry. To continue to
process a disabled chemistry, the operator must enable the chemistry. When the
disabled status is removed, the chemistry returns to the current calibration status.
n/a
Indicates calibration does not apply.
Reagent and Calibration Status Warnings
Introduction
When a reagent or chemistry calibration needs attention, a yellow or red warning highlight appears
in the applicable place on the Reagent Status/Calibration Status dialog box.
The highlight color depends on the reagent or calibration status.
Conditions that Cause a Calibration Status Warning
The table below lists the Calibration Status conditions and their related highlights.
Table 4.3 Conditions and Highlights for Calibration Status Warnings
IF the Calibration Status has...
Cal Required
Chem Bypassed
THEN the Highlight
is...
Red
Which Means...
The chemistry cannot be processed
now.
Cal Failed
Cal Timed Out
Disabled
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4
Reagent Load/Calibration
Request a Calibration
Table 4.3 Conditions and Highlights for Calibration Status Warnings (Continued)
IF the Calibration Status has...
Cal Overridden
THEN the Highlight
is...
Which Means...
Yellow
The chemistry needs attention, but the
process can continue.
Cal Time Extended
No warning condition or N/A
—a
The chemistry is OK and the process
runs normally.
a. — = No Highlight
Request a Calibration
Calibrate DxC Chemistries With Bar Code Labels
From the Rgts/Cal dialog box, check the Calibration Time Left column shown in days:hours:minutes
and the Cal Status column to see which chemistries require calibration.
1
Select Rgts/Cal from the menu bar.
2
Select the chemistries to be calibrated. If necessary, use the up and down arrows to select more
chemistries.
3
Select Cal F4.
4
Select List F5 to review the calibrator load list. Make sure the lot number on the calibrator
bottle agrees with the lot number seen on the screen.
5
Place a calibrator bar code label (with the name of the calibrator to be used) on a 16 mm
transport tube. Repeat for all calibrators. Make sure the correct bar code labels are in the
correct positions.
6
Place calibrator into sample cups.
• For Aqua cals 1, 2, and 3, fill a 0.5 mL cup.
• All other calibrators need 3 drops of calibrator in a 0.5 mL cup.
4-16
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Reagent Load/Calibration
Request a Calibration
7
Place the rack (1) in the autoloader (2) with the rack bar code label to the right. Press RUN (3)
on the analyzer.
Figure 4.10
1
2
3
A015925P.EPS
Calibrate DxC Chemistries Using Assigned Calibrator Racks
From the Rgts/Cal dialog box, check the Calibration Time Left column shown in days:hours:minutes
and the Cal Status column to see which chemistries require calibration.
1
Select Rgts/Cal from the menu bar.
2
Select the chemistries to be calibrated. If necessary, use the up and down arrows to select more
chemistries.
3
Select Cal F4.
4
Select List F5 to review the calibrator load list. Make sure the lot number on the calibrator
bottle is the same as the lot number on the screen.
5
Get the assigned calibrator racks listed on the screen and place the cups into assigned rack
positions as shown on the load list.
6
Place calibrator into sample cups.
• For Aqua cals 1, 2, and 3, fill a 0.5 mL cup.
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4-17
4
Reagent Load/Calibration
Calibration Failure Messages
• All other calibrators need 3 drops of calibrator in a 0.5 mL cup.
7
Place the rack (1) in the autoloader (2) with the rack bar code label to the right. Press RUN (3)
on the analyzer. Refer to Figure 4.10.
Cancel a Calibration Request
1
Select Rgts/Cal from the menu bar.
2
Select the appropriate requested and assigned chemistries to be canceled.
3
Select No Cal F8 to cancel calibration request.
Chemistries currently selected and programmed for calibration may be canceled only if the
calibration is not yet in progress.
Calibration reports for a given calibrator do not print until all calibrations are complete for each
chemistry requested, unlike sample and control results, which print on a cup-by-cup basis.
Calibration Failure Messages
Introduction
If there is a failure during calibration, for modular chemistry (MC) or cartridge chemistry (CC), there
is a pop-up message which shows:
• The chemistry that failed and
• The associated error code(s).
After a failure message, the operator can:
• Stop the calibration or
• Continue the calibration.
CC Subsystem Calibration Failure
The CC subsystem warns the operator of a failed calibration. If a chemistry fails, a pop-up message
appears after a completed calibrator level. The message includes:
• Calibrator name
4-18
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Reagent Load/Calibration
Within-Lot Calibration
• Chem name
• Reagent Position
MC Subsystem Calibration Failure
The MC Subsystem warns the operator of a failed calibration. If a chemistry fails, a pop-up message
appears after a completed calibrator level. The message includes:
• Chem name
• Calibration error
• Calibrator Name and Level Number
IMPORTANT Refer to CHAPTER 12, Troubleshooting Calibration and Result Errors for additional information
on Calibration Error messages.
Within-Lot Calibration
Introduction
The Within-Lot Calibration option provides multiple reagent load of cartridges of the same lot
number without having to calibrate each cartridge. The calibration factor established from a fresh
cartridge (less than 8 hours on board the instrument) is stored and applied to subsequently loaded
cartridges of the same lot.
Within-Lot Calibration Frequency
The length of time a within-lot calibration factor remains valid (its within-lot calibration
frequency) depends on the chemistry. During this interval any newly loaded cartridge with the
same lot number will receive the calibration status Calibrated. At the end of this frequency period,
a new within-lot calibration factor must be established from a fresh cartridge.
The calibration frequency of a particular cartridge has priority over the within-lot calibration
frequency. If a cartridge selected for within-lot calibration is still loaded at the end of its individual
calibration frequency period, that cartridge must be recalibrated (this will not affect the within-lot
calibration factor).
Enable Within-Lot Calibration
The system status must be Standby.
1
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Select Rgts/Cal from the menu bar.
4-19
4
Reagent Load/Calibration
Within-Lot Calibration
2
Select Options F6.
3
Select Within lot calibration from the pull-down menu.
4
From the pull-down menu, select a desired Configured Chemistry name. Refer to Figure 4.11.
5
Select Add to move the chosen Chemistry to the Selected Chemistries area.
6
Repeat Step 5 for other chemistries, if appropriate.
7
Select OK to enable the within-lot option for the selected chemistry.
OR
Select Cancel to exit without enabling.
Figure 4.11 Within-Lot Calibration Dialog Box
E015926S.EPS
NOTE If the within-lot calibration mode is disabled, any existing cartridges that are using the within-lot
calibration factor will retain that factor until the cartridge is depleted or until another calibration is
requested. When a chemistry is deselected, the following message appears:
"If chemistries are deselected, a new calibration factor will need to be generated for all subsequent
reagent packs loaded. Do you want to save changes to within-lot chemistries?"
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Reagent Load/Calibration
Within-Lot Calibration
Within-Lot Calibration Status Screen
The Within-Lot Calibration Status screen has a summary of the within-lot calibration time which
remains. This summary is for the cartridge chemistry/lot number combinations that have withinlot calibration factors applied.
1
Select a desired Configured Chemistry name from the Within-Lot Calibration dialog box. Refer
to Figure 4.11.
2
Select Status.
The within-lot chemistries appear by the within-lot calibration time remaining, the oldest
calibration date listed first. The lot number and the serial number of the cartridges are shown.
3
Select Close to exit the pop-up window and return to the Within-Lot Calibration screen.
Figure 4.12 Within-Lot Calibration Status Screen
E015927S.EPS
4
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Select Cancel to return to the Reagent Status and Calibration Status screens.
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4
Reagent Load/Calibration
Within-Lot Calibration
Within-Lot Designations
The designations wf, w, and ws follow the reagent lot numbers of those chemistries selected for
within-lot calibration. These designations are defined below.
Table 4.4 Definitions of Within-Lot Designations
Designation
wf
Description
Reagent has been enabled for within-lot calibration and the cartridge has been
"freshly" loaded. Any wf-designated cartridge can be used to establish a within-lot
calibration factor. A cartridge receives this designation if:
• it was loaded onto the system for the first time after within-lot calibration was
turned on.
• no more than 8 hours have lapsed since it was first loaded onto the system.
w
Reagent has been enabled for within-lot calibration. A cartridge receives this
designation if:
• it was loaded for the first time after a within-lot calibration was established.
• more than 8 hours have lapsed since it was first loaded onto the system.
ws
Reagent has been enabled for within-lot calibration but is a stand-alone (the
calibration factor currently used applies only to this cartridge). A reagent receives
this designation if:
• the cartridge was loaded before the within-lot calibration function was turned
on.
• more than 8 hours have lapsed since the cartridge was first loaded (it has a w
designation), and the cartridge is recalibrated.
• more than 8 hours have lapsed since the cartridge was first loaded (it has a w
designation) and a fresh reagent of the same lot is calibrated for within-lot use.
• the calibration status for the reagent becomes Cal timed out.
• within-lot calibration expires.
Within-Lot Calibration Limitations
Only one within-lot calibration factor per lot can be stored in memory. Any time a fresh cartridge is
calibrated for within-lot use, the previous within-lot calibration factor is overwritten.
Table 4.5 Reagent Calibration Requirements
If...
Then...
a newly loaded cartridge has the same lot
the new cartridge automatically receives the correct
number as a cartridge with previous within-lot calibration status; calibration is not necessary.
calibration,
4-22
the calibrator set point is modified,
within-lot calibration factor is lost and the calibration status
becomes Cal Required. This does not apply to the slope and
offset adjustment.
the lot number of the reagent is new to the
system,
calibration status is Cal Required for all cartridges of that lot
on the system.
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Reagent Load/Calibration
Enzyme Validator
IMPORTANT When you start to do a calibration on a fresh cartridge, you must complete it within 8 hours or
the within-lot calibration established will be less than optimal.
Enzyme Validator
Introduction
The Enzyme Validator option provides the ability to obtain IFCC/DGKCh (refer to Additional
Information below) equivalent answers for selective enzymes, or to obtain IFCC/DGKCh equivalent
answers for the non-IFCC/non-DGKCh formulation enzymes.
• The Synchron Enzyme Validator set is a human serum, albumin-based value assigned material
and is used like a calibrator.
• The feature can be turned on or off for applicable chemistries; the default is off.
• The Enzyme Validator Kit includes diskettes which provide set points for the selective enzymes.
IMPORTANT When the enzyme reagent is configured and loaded, and the Enzyme Validator feature turns
on, Enzyme Validator ID assignments and calibration requests can be performed in the same manner as
any calibrator.
1
Select Rgts/Cal from the menu bar.
2
Select Options F6.
3
Select Enzyme Validator.
4
Select a desired Configured Chemistry name from the pull-down menu.
5
Select Add to move the chosen Chemistry to the Selected Chemistries area.
6
Repeat Step 5 for other chemistries, if appropriate.
7
Select OK to enable the Enzyme Validator option.
OR
Select Cancel to exit without enabling the option.
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4
Reagent Load/Calibration
Calibration Override
Additional Information
DGKCh (Deutsche Gesellschaft für Klinische Chemie - German Clinical Chemistry Association)
IFCC (International Federation of Clinical Chemistry), a committee that establishes formulation
standards in Europe.
Calibration Override
Introduction
The Calibration Override option allows the system to override a failed calibration and obtain results
based on the failed calibration factors. Calibration Override is available only when an attempt to
calibrate the chemistries has been previously made and failed, the status Cal Failed is shown. A
chemistry with any other status, including Cal Required, cannot be overridden. The calibration can
be overridden while the system status is Standby, Disabled or Running.
IMPORTANT Overriding a calibration is not usually justified. However, there may be an emergency situation
when a delay caused by calibration is unacceptable to the laboratory. The magnitude of error which is
deemed acceptable when overriding a failed calibration is totally under the control of the laboratory.
Therefore, the Override function should be used with caution.
Override a Calibration
1
Select Rgts/Cal from the menu bar.
2
Select the Chem position to override.
3
Select Options F6.
4
Select Calibration override from the pull-down menu.
Remove Cal Overridden Status
The Cal Overridden status can only be removed by successfully recalibrating the chemistry or by
selecting Chem Bypass. A flag indicating that a particular chemistry has been overridden will
appear in the Instrument Code area on the appropriate Summary or Patient Chartable Results
report. Although a Cal Overridden status can be bypassed, the Cal Overridden flag is only removed
by a successful calibration.
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Reagent Load/Calibration
Chemistry Bypass
Chemistry Bypass
Introduction
In the event of a calibration failure for a chemistry which has been previously sample programmed,
Chemistry Bypass permits the continuation of analysis of all other programmed tests without
having to deprogram a failed chemistry. The chemistry can be bypassed while the system status is
Standby, Disabled or Running.
• The system will not aspirate sample or dispense reagents for bypassed chemistries. They will
not be marked as Pending.
• Bypassed chemistries are logged on the Post-Run Summary Report.
• Bypassed chemistries must be calibrated to process samples.
Bypass a Chemistry
1
Select Rgts/Cal from the menu bar.
2
Select the Chem position to bypass.
3
Select Options F6.
4
Select Bypass chemistry from the pull-down menu.
Remove a Bypassed Status
Recalibrate the chemistry to remove a bypassed status.
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4
Reagent Load/Calibration
Extend Calibration Time
Extend Calibration Time
Introduction
The Extend Calibration Time option allows the extension of a calibration that has exceeded the
recommended calibration time. The system shows a warning message approximately fifteen
minutes prior to the calibration timeout. At this point, the operator can recalibrate the chemistry
in question or extend the calibration time.
A calibration time can be extended if the current calibration for the chemistry:
• is valid but timed out
• is valid and not yet timed out
Extend Cal is not allowed if calibration has already been requested. If a chemistry is allowed to time
out, subsequent results will not be processed; however, extending the calibration time will allow
results to process and print.
Extend Calibration Time
1
Select Rgts/Cal from the menu bar.
2
Select Chem position to extend.
3
Select Options F6.
4
Select Extend calibration time from the pull-down menu.
The calibration status will show the updated information. A flag indicating that calibration
time has been extended will appear in the Instrument Code section on the appropriate
Summary or Patient Chartable Results report.
Remove an Extended Status
Calibration extension is indefinite. Recalibrate chemistry to remove an extended status.
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Reagent Load/Calibration
Calibration Acceptance Limits
Calibration Acceptance Limits
Introduction
Calibration absorbance or ADC values are compared to preprogrammed back-to-back, span, and
range limits to determine acceptable performance. If calibration errors in accuracy, precision,
sensitivity, or linearity are detected by the system computer, error flags are generated. Calibration
Acceptance provides a reference to the acceptable limits for calibration.
View Calibrator Acceptance Limits
1
Select Rgts/Cal from the menu bar.
2
Select Options F6.
3
Select Calibrator acceptance limits from the pull-down menu.
Chemistries appear with chemistry name, setpoint value(s), and appropriate limits.
4
Select Next or Prev to locate the calibrator of interest.
OR
Select the Calibrator Name pull-down menu at the top of the screen to view the List of
Calibrators.
5
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Select Close to exit the screen.
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4
Reagent Load/Calibration
Calibrator Set Point Modifications
Calibrator Set Point Modifications
Introduction
The Calibrator Set Point Modifications option allows editing of the programmed calibrator set
points. This option can be used to alter any chemistry provided it:
• has calibration data.
• uses three or less calibrator levels.
• is configured on the system.
The user-defined chemistry set points may be modified within the user-defined parameters setup.
Modify Calibrator Set Points
IMPORTANT Altering a programmed calibrator set point is not usually justified. However, there may be a
situation when a calibration value needs to be reassigned. Set Point Modification should not be used
routinely to correct instrument correlation. The magnitude of error which is deemed acceptable when
modifying a set point is totally under the control of the laboratory and, therefore, the Set Point
Modification function should be used with caution.
1
Select Rgts/Cal from the menu bar.
2
Select Options F6.
3
Select Modify set points from the pull-down menu.
4
Select Next or Prev to locate the calibrator of interest.
OR
Select the Calibrator Name pull-down menu at the top of the screen to view the List of
Calibrators.
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Reagent Load/Calibration
Slope Offset Adjustment
5
Move the cursor to the set point to be modified and type the desired value.
• If a previously modified set point is to be returned to the original default value for that
calibrator or chemistry, select desired chemistry, move cursor to the applicable set point
and select Restore Defaults.
• The default values have more significant figures than shown on the screen. Therefore,
select Restore Defaults, rather than typing the default values.
6
Select Close to exit the screen.
• Calibration status changes to Cal Required.
• A flag indicating that specific set points have been modified will appear in the Instrument
Code section on the results report.
Slope Offset Adjustment
Introduction
The Slope Offset Adjustment option allows adjustment of the slope (m) or the y-intercept offset (b)
of the regression equation used for results calculations. Modifications are made on a per chemistry
basis. The default value for the slope is equal to "1" and the default value for offset is equal to "0."
IMPORTANT Adjusting the slope and offset for a chemistry may result in a mismatch of normal range values
previously established.
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4
Reagent Load/Calibration
Slope Offset Adjustment
Slope Offset Recommendations
When slope and offset modification is desired, the slope and offset values to be used must be
experimentally derived from statistically significant patient correlation studies. It is recommended
that patient samples are run over a period of several days by both methods, using controls to
monitor accuracy. A good range of data should be achieved by analyzing below normal, normal, and
above normal samples. Patient sample data (only) should be used for linear regression analysis with
Synchron values as y values and other method values as x values. A minimum of 40 patient samples
is recommended. From this analysis, the regression equation in the following form is obtained:
y = mx+b
where:
y
=
Synchron value
x
=
other method value
m =
slope of regression line
b
y-intercept of regression line (offset)
=
To obtain the desired slope and offset values for entry into the Slope/Offset Adjustment screen, the
equation above must be rearranged as follows:
x = (y - b) / m
x = (y × 1 / m) + (-b / m)
Slope = 1 / m
(value to be entered)
Offset = -b / m
(value to be entered)
The Synchron values need to be multiplied by the slope value and then the offset value is added:
Reported sample result = Synchron calculated sample result × (slope) + offset.
4-30
1
Select Rgts/Cal from the menu bar.
2
Select Cal Options F6.
3
Select Slope/Offset adjustment from the pull-down menu.
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Reagent Load/Calibration
Reprint Calibration Reports
4
Move cursor to the slope and/or offset to be modified.
OR
Press (Page Up) or (Page Down) from the keyboard or use the screen scroll bar to locate the
Chem. Type the desired value in the appropriate Slope and Offset fields.
• If a previously modified slope or offset is to be returned to the original default value for that
calibrator or chemistry, select desired chemistry, move cursor to the applicable field and
select Restore Defaults.
5
Select Close to exit screen.
Reprint Calibration Reports
Introduction
The five most recent calibration reports for a given calibrator (chem position) may be printed for
an historical perspective.
Reprint Current Calibration Reports
1
Select Rgts/Cal from the menu bar.
2
Select the chem position(s) to print.
NOTE When requesting reports of recent MC calibrations, select only one chemistry per report format.
This prevents duplicate copies. For example, if NA is selected, the report contains all five ISE
chemistries.
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3
Select Options F6.
4
Select Print Cal Report from the pull-down menu.
5
Select Current Cal Report from the Print cal report dialog box. The report(s) automatically prints.
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4
Reagent Load/Calibration
Reprint Calibration Reports
Reprint Previous Calibration Reports
1
Select Rgts/Cal from the menu bar.
2
Select Options F6.
3
Select Print cal report from the pull-down menu.
4
Select Previous cal report(s) from the Print cal report dialog box.
5
Select the desired Configured Chemistry name(s) from the Previous cal report(s) dialog box.
NOTE When requesting reports of recent MC calibrations, select only one chemistry per report format.
This prevents duplicate copies. For example, if NA is selected, the report contains all five ISE
chemistries.
4-32
6
Select Add to move the chosen Chemistry(ies) to the Selected Chemistries area, then select OK.
7
Select 1, 2, 3, 4 or 5 most recent reports to print from the Print Previous Cal Report dialog box.
The report(s) automatically prints.
A13914AF
CHAPTER 5
Quality Control
Quality Control
Introduction
This task is performed when your laboratory protocol indicates that control material should be
analyzed. A daily analysis of at least two levels of control materials is highly recommended. In
addition, these controls should be run with each new calibration, with each new lot of reagents, and
after specific maintenance or troubleshooting activities. However, users should determine their
own frequency based on the NCCLS Proposed Guideline C24-P INTERNAL QUALITY CONTROL
TESTING: PRINCIPLES AND DEFINITIONS.
Quality Control Program
The system Quality Control program provides the capability of monitoring system and chemistry
performance by performing real-time analysis of control data.
The QC data is presented in both a summary format and in a chart format. Westgard QC rules are
applied to the data to aid in determining chemistry and system reliability.
Determination of QC Flags
The DxC uses the Z-score method for standardizing the scale of a normally distributed
measurement variable. For an individual control result, the Z-score represents the distance in
standard deviations from the assigned mean. The Z-score is calculated from the following equation
where:
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5-1
Quality Control
Quality Control
X = the individual control result
X = the assigned mean for the control
SD = the assigned standard deviation for the control
Z=
X-X
SD
E014425L.EPS
Each time a control result is received, the Z-score is calculated. If the Z-score is less than ± 2 SD, the
result is within the assigned control range (the assigned mean ± 2 assigned standard deviations) and
is considered acceptable.
NOTE Results are flagged at time of run. Flagging is not changed if the operator modifies the assigned mean
and/or SD.
Accuracy and Precision Flags
The DxC uses the following Westgard rules for evaluation of QC data.
• 1-2S: Result Between ± 2SD and ± 3SD From the Assigned Mean
If the result is between ± 2 and ± 3 standard deviations from the assigned mean, the result:
— is flagged as > 2SD on the QC Log report.
— appears in yellow on the QC LOG and QC CHART screens.
— is highlighted in a pop-up note on the monitor as the system is running.
• 1-3SD: Result Greater Than 3SD From the Assigned Mean
If the result is greater than ± 3 SD from the assigned mean, the result:
— is flagged as > 3SD on the QC Log report.
— appears in red on the QC LOG and QC CHART screens.
— is included in a real-time pop-up window as the system is running.
• 2-2S and R-4S: Results Between 2 SD and 3 SD as Compared to the Previous Result
In addition, the Z-score for the current result is compared with the Z-score of the previous
result in the same QC file. If both Z-scores are beyond 2 SD on the same side of the assigned
mean, the current result receives an "Accuracy" flag on the QC Log report; this flag signifies a
violation of the 2-2S rule. These values appear red in the QC log and QC chart.
If the two results being compared are greater than 2 SD on opposite sides of the assigned mean,
the current result receives the "Precision" flag on the QC Log report, signifying a violation of
R-4S rule. These values appear red in the QC log and QC chart.
• Results Greater Than 4 SD From the Assigned Mean
Results greater than 4 SD are included in the QC Log and QC Chart, but are not used to calculate
statistics.
5-2
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Quality Control
Quality Control
Flags Generated on Printed QC Reports
These flags appear in the remarks column of the QC results report:
• Greater than 2SD
• Greater than 3SD
• ACC (Accuracy) two successive controls greater than 2SD
• PRE (Precision) two successive controls greater than 2SD on opposite sides of the assigned mean
• Mean and/or SD not assigned
Additional QC Precision Rules
Some additional Westgard QC rules are helpful when determining whether the system is in control.
These are not flagged by the DxC QC package but can help in determining system performance.
Refer to Figure 5.1.
• 4-1S Within or Across: Last Four Results of One or Two Levels of Control Were More than 1 SD
From the Mean on the Same Side
This rule judges the result out-of-control if the last four results from one or two levels were
more than 1 SD from the mean in the same direction.
• 10X Within or Across: Last Ten Results of One or Two Levels of Control Were All on the Same
Side of the Mean
This rule judges the result out-of-control if the last ten results from one or two levels were all
on the same side of the mean.
Figure 5.1 QC Accept/Reject Chart Using Westgard Rules
Control
Data
1
2S
ACCEPT/REJECT CHART
NO
IN CONTROL
ACCEPT RUN
YES
1
3S
NO
NO
YES
2
2S
NO
YES
R
4S
NO
YES
OUT - OF - CONTROL REJECT RUN
4
1S
NO
YES
10
X
YES
EVALUATE
E015001L.EPS
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5-3
5
Quality Control
Define a Control
When defining controls, Control IDs should be as descriptive as possible. Refer to the UniCel
DxC Synchron Clinical Systems Reference Manual for further details. The following procedures
describe how to run control samples.
Define a Control
Introduction
The operator may define up to 100 controls. The minimum input required to save a control
definition is control name, lot number, QC file number, sample type, and one chemistry selection
per control. The maximum number of configurable chemistries is 175 per control.
Controls may be edited by adding or deleting individual chemistries, and modifying the mean, SD,
and constituent codes.
Special or Unique Control Samples
Only compatible chemistries should be defined together in the same control definition. Pre-treated
samples (for example, IBCT), diluted samples, or samples of different sample types should be
defined as separate controls.
Control Description
All described fields of the control definition screen (Define/Edit Controls) must be filled in before
leaving the control definition screen, otherwise the control will not be saved.
Control identifiers are fields used to identify a specific control. This information includes:
• Control Name
• Control Lot
• Sample Type
Define a Control
IMPORTANT When defining a control, it is important to select the Sample Type (Step 7) before selecting the
chemistries (Step 8). Failure to follow the procedure as described may result in the wrong units being
assigned to a chemistry.
5-4
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Quality Control
Define a Control
1
Select QC from the menu bar.
2
Select a control number from the QC dialog box.
3
Select Define F2.
4
Type the name of the control to be defined in the Control Name field. The control name must
be unique with a maximum of 20 alphanumeric characters.
NOTE When defining control names, avoid the following characters used by ASTM standard delimiters:
• "|" Vertical bar
• "\" Back slash
• "^" Caret
• "&" Ampersand
5
Type the control lot number in the Control Lot No. field. The control lot number has a maximum
of 12 alphanumeric characters.
6
Serum Index is an optional function. If Serum Index is applicable to your control material,
select the Serum Index check box.
For additional information on serum index, refer to the Synchron Clinical Systems Chemistry
Reference Manual.
7
Select or cursor to the Sample type field. Select the pull-down menu next to the Sample type
field and select the sample type.
The following sample types are available: Serum, CSF, Plasma, Random Urine, and Other. If a
sample type is not selected, the default sample type is Serum.
8
Select Chems F1. A list of configured chemistries appears. Add or remove chemistries by
selecting and adding to the list, or by selecting and removing from the list. Use the scroll bar to
access all chemistries.
• Select OK to leave the selection screen and save the chemistry selections.
• Select Cancel to exit without changing the chemistry selection.
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5
Quality Control
Define a Control
9
Type the following information in the appropriate fields for all chemistries shown:
Field
QC File Number
Description
Type a QC file number for each chemistry.
• The QC file number must be a unique 3-digit number from 1 to 999.
• If a QC file number has already been assigned, the system will not
accept it a second time. Refer to Display QC File Lists in this
chapter to obtain a list of used QC File numbers.
Assigned Mean
Type the assigned mean for the chemistry level and lot. The system
adds zeroes to the end of the number to show maximum precision
(X.XXX).
Assigned SD
Type the assigned standard deviation, ±1SD. The system adds zeroes
to the end of the numbers to show maximum precision (X.XXX).
Constituent Code This field is optional. If desired, type the constituent code.
10 Select Done F10 to leave the definition screen and to save the control.
Minimum requirements to save a control definition are control name, lot number, sample type,
QC file number and one chemistry selection.
If the control definition is not complete, a warning message will appear specifying which
information is missing. The operator has the option of exiting the control definition screen or
returning to the definition screen to add the missing information.
If exiting the definition screen without filling in the missing fields, the following will occur:
Exiting the screen without QC File Number not fully defined will delete any chemistry missing
this information.
If returning to the definition screen, verify that all of the following definition fields have been
filled for any control or requested chemistry:
• Control Name
• Control Lot Number
• QC File Number
Delete Controls from Definition Screen
Selecting the Delete F3 key deletes all definitions for the current control definition.
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Quality Control
Control ID Assignments
Control ID Assignments
Introduction to Assignment of QC Bar Codes
A maximum of eight bar codes (control IDs) per control may be defined. Assignment of bar code IDs
is mandatory for Auto Generation of controls.
Assignment of QC Bar Codes
1
Select Control ID F2 from the Define/Edit dialog box.
2
The Control ID dialog box appears. A maximum of eight unique bar code IDs with a maximum of
15 alphanumeric characters may be entered. Press (Tab) after each bar code entry to move
between fields.
When creating Control Bar Code IDs, use a format that is distinctly different from Sample IDs.
This will prevent the reporting of erroneous results due to Controls being run as patient
samples, or patient samples being run as controls.
Example:
Control Bar Code ID: SYNCHRON01
Sample Bar Code ID: 0000001
3
Select OK to exit the screen and save the bar code IDs.
OR
Select Cancel to clear all modifications.
Print Bar Code Assignments
Press the (PrtScn) key to print the Control ID assignment window.
Run Control Samples
Introduction
When the control is defined, the control sample runs on the instrument with or without bar code
labels. The following procedures describe how to run a control sample for each condition.
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5
Quality Control
Run Control Samples
Run Control Samples With Bar Code Labels and Auto Generation
of Control Enabled
1
Place bar-coded control samples in rack. All tube bar code labels must be visible through the
slots on the same side of the rack as the rack bar code label.
2
When Auto Generation of Control is enabled, the automatic Multiple Cartridge option is
available. With the Multiple Cartridge option enabled, the system automatically runs all
cartridges onboard and runnable for any chemistries for an auto generated control. To enable
Multiple cartridge from the Setup screen, scroll down and select 29 Auto Generation of Control.
3
Press RUN on the analyzer.
The instrument automatically runs chemistries that are:
• Defined for the control.
• Loaded and calibrated.
• Contain sufficient volume to run the controls.
4
If all tests programmed for an Auto Generated control ID do not complete testing (for example,
reagent not onboard, calibration required, cal time exceeded or disabled), the next time the
control ID is loaded, all tests for the control will Auto Generate and be run again. If a control ID
that was Manually programmed does not complete testing, the next time the control ID is
loaded, only the incomplete test will be run. A Manually programmed control ID that is
incomplete must be manually cleared before reloading the sample in order to Auto Generate all
tests for the control.
Manually Programming Control Samples
1
Select Samples from the menu bar.
2
Clear the QC sample ID to be used.
• Select Clear F7.
• Type the QC sample ID into the Sample ID(s) field.
• Select OK.
• Select OK to confirm.
3
5-8
Select Control F5.
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Quality Control
Edit a Control Definition
4
Select the number next to the Control Name field to select from predefined Control Names. If
necessary, use the scroll bar to view additional Control Names.
OR
Type the number in the No. field.
The Program Control screen opens. Make sure the Control Lot number on the screen is the same
as the lot number on the Control bottle.
5
Type the rack/position number if the bar code is not available.
6
Select chemistries to be run.
NOTE In Manual QC Programming, the system automatically runs the oldest cartridge onboard for the
selected chemistry. Specific cartridges (other than default) may also be selected. To access duplicate
or specific cartridges, select Rgt Cart F8. Then select the desired cartridges and select OK.
7
Select Save F10 to save the control programming and return to the Program Sample screen.
IMPORTANT If all tests programmed for the control do not complete testing (for example: calibration
required, cal time exceeded or disabled), the next time the control ID is loaded, only the incomplete tests
will run. To run all chemistries (autogeneration of control), the control ID must be cleared manually before
reloading the sample.
Edit a Control Definition
Introduction
The assigned mean, SD, constituent code, and bar code IDs of a previously defined control may be
edited. The QC File Number associated with any defined control may not be edited.
Edit Precautions
• Changing the mean and/or standard deviation may affect subsequent QC statistical data.
Changing previously defined mean and/or SD to zero will set the mean to zero, and the SD to
99999.
• Subsequent data points will be compared to the new mean and SD.
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Quality Control
Edit a Control Definition
Modify Assigned Mean, Assigned SD or Constituent Code
1
Select QC from the menu bar.
2
Select the control number beside the Control Name and select Define F2.
3
Select the field for modification.
4
Type the modified assigned mean, standard deviation (1 SD), or constituent code.
5
A Define/Edit Control dialog box prompts the operator to choose how the changes will be applied
to subsequent data. Select the desired option, or type the item number of the desired action.
Select Cancel to exit the Define/Edit Control dialog box without saving the modified values.
6
If a change was made to the mean, SD, or constituent code, the change is reflected in the Define/
Review screens. If changes were not saved, the previously defined mean/SD are shown.
NOTE If the assigned mean and SD were modified and the existing data points were not deleted, all
previous flagging will remain based on original assigned mean and SD.
7
Exit the Define/Edit Control dialog box by selecting Done F10.
Add Chemistry(ies)
1
Select QC from the menu bar.
2
Select the control number beside the Control Name and select Define F2.
3
Select Chems F1. A list of configured chemistries appears. Add chemistries by selecting and
adding to the list. Use the scroll bar to access all chemistries.
• Select OK to leave the selection screen and save the chemistry selections.
• Select Cancel to exit without changing the chemistry selection.
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Quality Control
Edit a Control Definition
4
Type the following information in the appropriate fields for all chemistries shown:
Field
QC File Number
Description
Type a QC file number for each chemistry.
• The QC file number must be a unique 3-digit number from 1 to 999.
• If a QC file number has already been assigned, the system will not
accept it a second time. Refer to Display QC File Lists in this
chapter to obtain a list of used QC File numbers.
Assigned Mean
Type the assigned mean for the chemistry level and lot. The system
adds zeroes to the end of the number to show maximum precision
(X.XXX).
Assigned SD
Type the assigned standard deviation, ±1SD. The system adds zeroes
to the end of the numbers to show maximum precision (X.XXX).
Constituent Code This field is optional. If desired, type the constituent code.
5
Select Done F10 to leave the definition screen and to save the control.
Remove Chemistry(ies)
1
Select QC from the menu bar.
2
Select the control number beside the Control Name and select Define F2.
3
Select Chems F1. A list of configured chemistries appears. Remove chemistries by selecting and
removing from the list. Use the scroll bar to access all chemistries.
• Select OK to leave the selection screen and save the chemistry selections.
• Select Cancel to exit without changing the chemistry selection.
4
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Select Done F10 to leave the definition screen and to save the control.
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Quality Control
Review a Control Definition
Review a Control Definition
Introduction
A control definition can be reviewed from either current QC data or archived QC data. Archived QC
data may not be modified, only printed. Current QC data may be reviewed, deleted, or printed.
Review a QC
1
Select QC from the menu bar.
2
Select a control number.
3
Select Review F1.
All current information and selected chemistries appear, including serum indices.
•
Control ID F2 can be accessed to view the eight bar code IDs.
•
Delete F3 can be used to clear a control.
• Select Print F9 to print a control.
• When reviewing QC definition, no cursor will be available because changes are not allowed.
4
Exit the Review screen by selecting Done F10.
Delete a Control
Introduction
Previously defined controls may be deleted and removed from the system. Clearing QC ranges and
applicable data can be done for Current QC data only. Controls may also be deleted through define,
edit, and review QC functions.
Controls with Incomplete status cannot be deleted. Clear the Control ID at the Program Sample
screen.
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Quality Control
Print QC Ranges
Delete a Control
1
Select QC from the menu bar.
2
Select the control to be cleared.
3
Select Delete F3.
4
The following message appears to confirm the clearing of the selected control:
"All QC files for control will be deleted. Archiving is suggested. Delete this control?"
• Select OK to delete the control.
OR
• Select Cancel to retain the control information.
5
If the control was deleted, type an operator ID of 1 to 3 alphanumeric characters and press
(Enter) .
Print QC Ranges
The entire database of controls may be printed.
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1
Select QC from the menu bar.
2
Select the control to be printed.
3
Select Print F10.
4
To print additional control ranges, repeat Steps 2 and 3.
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Quality Control
QC File List
QC File List
Introduction
QC File List allows the operator to view and/or print a list of QC files by control name, chemistry
name or QC file number. The QC File List is accessible from either Current QC data or Archived QC
data.
QC File Definition
A QC file is a grouping of control information for a particular chemistry in a particular control (for
example, control lot number, mean, SD, cumulative sums).
The QC file number is the unique number assigned by the operator to identify a particular QC file.
Refer to Define a Control in this chapter. A control can be associated with one or more QC files.
Display QC File Lists
1
Select QC from the menu bar.
2
Select List F4.
3
If no control is selected, the system shows all chemistries in all controls with chemistries in
alphabetical order. The QC File list appears with all defined controls listed in ascending order.
Use the scroll bar to view additional file numbers.
4
To view specific chemistries or see all QC file numbers associated with a specific chemistry:
• Select AllChem F1. A screen appears with chemistries and file numbers sorted by chemistry.
OR
• Select AllFile F2. A screen appears with QC File number and chemistries sorted by QC file
number.
Use the scroll bar to access additional chemistries if necessary.
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Quality Control
QC Summary
QC Summary
Introduction
• The QC Summary report contains the mean, SD, CV and number of results (N) for any control
run within a specified date interval. The printed report contains the cumulative mean, SD, CV
and (N)umber of accumulated results.
• The QC Summary is also available in the Inter-Laboratory format. The constituent code must
be defined in order for a chemistry to be included in the Inter-Laboratory QC Summary. To
enter the Inter-Laboratory reference number and contact person to be included in the InterLaboratory QC Summary, access Report Setup through System Setup.
Accessing the QC Summary
1
Select QC from the menu bar.
2
A list of currently defined controls appears. Select the control for the QC Summary. If
necessary, use the scroll bar to view additional controls.
3
Select Summary F6.
4
Type a Start date and an End date using the dd/mm/yy format. The default Start/End date is
the current date. Press (Tab) to move between fields.
• Select OK to view the QC Summary.
OR
• Select Cancel to return to QC screen.
If no data is available, the following message appears:
"No Data Available."
5
To print a hard copy of the summary, select Print F9.
To print the Inter-Laboratory format of the QC Summary, select InterLab F8.
6
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To exit the QC Summary dialog box, select Done F10.
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5
Quality Control
QC Chart (Levey-Jennings)
QC Chart (Levey-Jennings)
Introduction
QC Chart shows the results of a control for a specified period (default is current date) in a graphic
form, showing the position of data points relative to the assigned mean and standard deviation. The
results are listed by date and time, most recent results first. QC Chart is available from either the
hard disk or the diskette.
NOTE Color flagging is based on assigned mean and SD at time of run. If assigned mean and/or SD are
modified, flag color will not change.
QC Chart retrieves only the 4000 most recent results within the date range specified. If more than 4000
results are within the date range, the system does not print the oldest results. You may need to specify
another date range to retireve the additional results.
Accessing QC Charts
1
Select QC from the menu bar.
2
From the QC screen, select a currently defined control. If necessary, use the scroll bar to view
additional controls.
3
Select Chart F7.
4
Type a Start and End date for the QC Chart in the date range fields. The default Start/End date
is the current date. Press (Tab) to move between data fields.
NOTE If no data exists for the dates entered, the message "No Data Available" appears.
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Quality Control
QC Chart (Levey-Jennings)
5
The chemistries defined for the selected control are listed. All chemistries appear to be
selected.
For convenience, there are two ways to select the chemistries to chart:
• To chart most of the chemistries shown, select all chemistries which should NOT be
charted. Then select Remove.
• To chart less than half of the chemistries shown:
— Select Remove All.
— Select the chemistries to chart.
Multiple selections are allowed. Use the scroll bar to access additional chemistries.
NOTE User-defined chemistries which have been cleared cannot be retrieved for QC Chart.
• Select OK to show the QC Chart(s).
• Select Cancel to cancel the Chart request.
6
Select Next F8 to access all requested QC charts. Each of the requested charts appear in the
order of the control chemistry configuration.
7
Select Print F9 to print a copy of the Chart.
8
Select Chems F1 to specify additional chemistries for charting.
9
Select Filenum F2 to specify additional file numbers for charting.
10 Select Done F10 to exit the QC Chart dialog box.
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Quality Control
QC Log
QC Log
Introduction
QC Log shows results with information about the relationship of those results to the assigned mean,
SD and previous results for a specified data interval. Also shown are data point deletions. The QC
Log may be viewed and/or printed from either the hard disk or the diskette. Data points may be
deleted at the operator's discretion from the hard disk only. An action log comment may be added
from the QC Log screen.
NOTE Color flagging of results is based on assigned mean and/or SD at time of run. If assigned mean and/
or SD are modified, flag color will not change.
QC Log retrieves only the 4000 most recent results within the date range specified. If more than 4000
results are within the date range, the system does not print the oldest results. You may need to specify
another date range to retireve the additional results.
Accessing QC Logs
1
Select QC from the menu bar.
2
Select the control desired.
3
Select Log F5 from the QC dialog box.
4
Type a Start date and an End date in the date range fields. The default Start/End date is the
current date. Press (Tab) to toggle between fields.
• Select OK to continue.
OR
• Select Cancel to return to the QC dialog box.
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Quality Control
QC Log
5
The QC Log may be viewed by Chemistry or by Reagent Lot.
The default view is in alphabetical order by chemistry, with most recent data entries first. Also
shown are the date, time run, result, units, and interpretation of the data (relationship of the
result to the assigned mean and previous results).
To view the QC Log by Reagent Lot:
• Select Rgt Lot F2.
• Type the Start and End date.
• Select OK to view.
OR
• Select Cancel to return to the previous screen.
6
Data is shown by chemistry with reagent lot listed in descending order.
• Use the scroll bar to access additional data.
Data are shown as follows:
— Data points > 2 SD appear in yellow.
— Data Points > 3 SD appear in red.
— Data Points > 2 SD with Precision or Accuracy flags appear in red.
For a description of how accuracy and precision are determined, refer to Accuracy and
Precision Flags in this chapter.
Delete a Data Point
IMPORTANT QC data points should only be deleted when the system is in Standby or Stopped state.
Deleting a chemistry data point from a QC control file that has the same chemistry/control combination
actively running on the system may cause the system to update the QC files incorrectly.
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1
Select a data point by selecting the check box next to the data point.
2
Select Delete F3.
3
Type the password (if secured) and ID initials and press (Enter) .
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Quality Control
QC Log
4
The following message appears verifying the deletion of the data point:
"QC data point will be deleted. Archiving is suggested. Delete QC data point?"
• Select OK to delete the data point.
OR
• Select Cancel to retain the data point.
5
The data point will still appear within the QC Log. It will, however, be marked with the initials
of the operator who deleted it. The data point will no longer be included in any calculations or
summaries.
NOTE This feature is not available for external media; however, it is not grayed out. If the feature is selected
for external media, no error message shows.
Add a QC Action Log Comment
1
Select a data point by selecting the check box next to the data point.
2
Select Action F4.
3
Type the password (if secured) and ID initials.
4
The QC Action Log appears. There are 30 characters in the field.
• Write a comment about the data point.
• Select OK to save the comment.
OR
• Select Cancel to erase the comment.
5
To exit the QC Log screen, select Done F10.
NOTE This feature is not available for external media, however, it is not grayed out. If the feature is selected
for external media, no error message shows.
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Quality Control
Quality Assurance Program (QAP) “Copy To Disk” Feature
Quality Assurance Program (QAP) “Copy To Disk” Feature
Introduction
The QAP Copy to Disk feature allows QC data to be copied to a DOS-formatted diskette. This data can
then be uploaded to the Beckman Coulter website for processing as part of the Inter-laboratory QC
data reduction program.
Create a QAP Disk
CAUTION
When transferring data to a diskette, all data on the diskette created prior to the
current day will be deleted. Either use a new diskette for each new data transfer
OR be sure that the data on a previously used diskette has already been uploaded
to the Beckman Coulter website.
NOTE You can store multiple files created from the same analyzer OR files created from multiple analyzers
on the same diskette, provided that the files are created on the SAME day. Otherwise, the data will be
deleted. Data from multiple analyzers will be identified by instrument serial number and sequence
number on the diskette.
1
Select QC from the menu bar.
2
Select the Control Name containing the data you wish to transfer.
3
Select Summary F6.
4
Type the QC Date Range for the data you wish to transfer FROM mm/dd/yy TO mm/dd/yy.
5
Select OK to continue.
OR
Select Cancel to return to the QC screen.
6
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Select QAP Disk F7.
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Quality Control
Quality Assurance Program (QAP) “Copy To Disk” Feature
7
Type the two digit month and the four digit year the data represents.
IMPORTANT A date will not be accepted if it is more than 24 months prior to the current date or if it is
a future date.
8
Select OK to continue.
OR
Select Cancel to return to the QC Summary screen.
9
Follow the prompt on the screen and insert a blank, DOS formatted 3.5 inch diskette into the
console disk drive.
IMPORTANT A message will display if an error occurs with the diskette. Be sure to use a DOS formatted
3.5 inch diskette.
10 Select OK to continue.
OR
Select Cancel to return to the QC Summary screen.
11 If the diskette copy is successful, the following message appears:
“QAP diskette creation complete.”
Select OK to exit this screen.
12 Select DONE F10.
13 If necessary, repeat Steps 2 to 12 above to add additional data to the same diskette. Otherwise,
you may go to any screen using the menu bar icons.
The diskette is now ready for data to be uploaded to the Beckman Coulter website.
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Archive QC
Archive QC
Introduction
The Archive QC function archives control definition (control name, lot number, sample type, QC File
number, QC Log selected chemistries, assigned mean and SD, constituent code, and cumulative
mean, SD and N) and results to a diskette. Archiving is available from the hard disk only. The
archived diskette can be used to review data, but not to modify QC files. The system must be in
Standby to archive QC data.
The QC database can store at least 35,000 results. If a new result is processed and the QC Results
database is full, the oldest result related to the new result will be overwritten. If the QC Results
database is full and no results are associated with the QC File number of the new result in process,
the new result will not be saved. The operator will be notified that the new result was not saved.
When this dialog box notification appears, it may be appropriate to archive.
Archive QC
IMPORTANT To archive Current QC Data to a diskette, the diskette must be Double-sided, High Density.
1
Select QC from the menu bar.
2
From the QC screen, select Archive F8.
3
Select 1 Archive to Disk.
OR
Type 1 in the Option No. field and press (Enter) .
4
At the prompt, type an operator ID of 1 to 3 alphanumeric characters.
5
To confirm the continuation of the archive process, select OK.
To discontinue process, select Cancel.
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Quality Control
Review Archived Data
6
Insert a disk and select OK at the prompt when ready. The disk will be formatted by erasure,
then the QC data will be archived to it.
CAUTION
When QC data is deleted from the hard disk, no modifications are allowed.
NOTE When archiving is complete, a prompt will ask the operator if QC data should be deleted from the
hard disk.
7
Select OK or Cancel.
NOTE If the operator selects OK to the delete QC data prompt, a warning appears.
8
Press (Enter) to initiate deletion.
9
Select a date interval for QC data deletion by typing a Start date and an End date in the date
range fields.
Review Archived Data
Introduction
Archived data can be reviewed from a diskette. Review options available from the floppy include
review of demographics and cumulative statistics for a control file, viewing and printing of QC File
List, QC Log, QC Summary and Control Ranges. No modifications to the archived control files are
allowed.
Review Archived Data
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1
Select QC from the menu bar.
2
Select Archive F8.
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Quality Control
Review Archived Data
3
Select 2, Review Disk.
OR
Type 2 and press (Enter) .
4
Insert the archive disk and select OK at the prompt.
5
Information about the archive disk (date archived, operator ID, start date, end date) appears.
• If the information indicates that the proper disk was entered,
— Select Cancel to stop the disk review process and return to the Archive menu.
— Select OK to view another disk.
— Continue to Step 6.
• If the information indicates that this is not the proper diskette,
— Select OK and insert the next diskette
— Review the information shown and
— Select OK or Cancel accordingly as described above.
6
Select External Media from the QC dialog box.
Diskette retrieval provides access to date review of Control Ranges, QC Log, QC Summary and
QC Chart. No modification to the data is allowed.
7
Select any of the following options:
•
Review F1 to review archived control definition.
•
List F4 to view and Print archived QC File lists.
•
Log F5 to view the Log for the archived data.
•
Summary F6 to view and print a summary of the archived data.
•
Chart F7 to view a specific archived control chart.
•
Print F10 to print archived control ranges.
Refer to the appropriate sections in this chapter for specific instructions on each of the listed
functions.
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Quality Control
Review Archived Data
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CHAPTER 6
Sample Programming and Processing
Overview
Introduction
Sample programming provides the ability to identify samples, select tests to run, describe samples,
and designate how to run samples. Samples are programmed through a host computer, Laboratory
Information System (LIS), or at the analyzer. The minimum information required to save a sample
program includes:
• a Sample ID or
• a rack and position assignment
• and one test selection
Test selections are assigned by use of panels or by selection of individual tests.
NOTE The system can run only 50 chemistries per Sample ID at one time (for example, for a QC Sample). If
you program more than 50 tests for a Sample ID, the additional tests will cause an INCOMPLETE status
for the Sample ID.
Samples may be described and defined through use of the Sample Type, Sample Comment, Patient
ID, and Patient Demographics functions. The Sample Options feature allows modification of the
sample replicates, modification of the test replicates, entry of an off-line dilution factor, select/
deselect serum index, and programming of a manual ORDAC. A sample can be designated as a
Control sample or as a STAT for priority processing. Samples can also be programmed in a batch,
rerun, and cleared. A Load List that shows pending tests can be requested, as needed. After samples
are programmed, they are placed on the autoloader for processing.
Color is used to indicate if the chemistry is not runnable or if the chemistry is set for manual ORDAC.
Refer to Selecting Tests, Chemistry Identifiers in this chapter.
These features are described in more detail in the following sections.
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Sample Programming and Processing
Prior to Programming
WARNING
If your LIS or normal workflow requires the reuse of sample IDs, the sample
programming should be cleared from the DxC at a time interval that is less than
the shortest time of sample ID reuse. The DxC over-write feature is not sufficient
for successfully reusing sample IDs. If this warning is not followed, results from
the new request are merged with tests from incomplete samples that previously
used that ID. In addition, patient demographics at the instrument are from the
previous use of the sample ID. Since demographics are not uploaded from the
instrument, it is possible for these merged results to be uploaded to the LIS which
would contain the current demographics.
Figure 6.1 Program Sample Screen
E016486S.EPS
Prior to Programming
Introduction
Prior to programming, it is necessary to verify rack status and sample carousel status. These
options determine which racks are available for programming, for rack assignment, and for
determining the instrument status.
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Sample Programming and Processing
Prior to Programming
Rack Status
Patient samples, controls, or calibrators may be assigned to racks which are then loaded onto the
system for sample processing. Each rack is uniquely numbered (1–999) and can be assigned a
maximum of four positions. The Rack Status screen shows information about the current
programming for a rack, designating how many positions within a rack are available for
programming. Racks can be viewed and cleared from this screen. Only manually assigned samples
or controls need to be cleared from racks.
1
Select Samples from the menu bar.
2
Select Racks F8.
3
Select a rack or type a specific rack number in the Rack field to view Sample Status. Refer to
Table 6.1, for a description of each Sample Status. Press (Page Up) or (Page Down) to view
additional rack numbers.
4
The following functions are available:
• To clear a rack or several racks:
— Select Clear F1.
— Type rack or Sample ID and select OK.
— Select OK again to confirm deletion of sample programs.
• To return to Sample Programming without making changes:
— Select Cancel F9.
• To select a rack to program a sample:
— Select a rack with an available position.
— Enter the manual assignment information.
— Select OK to save.
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6
Sample Programming and Processing
Identify Samples
Table 6.1 Sample Status Designations
Sample Status
Meaning
In Progress
Sample has been identified and is currently being sampled for programmed
tests.
Incomplete
Sample has completed all tests possible and has some tests which are still
pending.
Complete
All tests have been completed.
Reserved for Cal
Rack/Position assigned to a calibrator.
Sample Required
Sample is programmed but not yet run by the system.
Rerun
Sample has been requested for rerunning.
Removed
Sample has been unloaded but some tests are still being processed.
Manual Assign
Sample ID has been manually assigned to a Rack/Position.
Verify Sample Carousel Status: Main Screen
The status of racks currently loaded on the sample carousel can be viewed on the Main screen. The
status of each sample is designated by an icon, described by the legend at the top of the screen.
Refer to CHAPTER 1, System Description, Main Screen for additional information on Sample Carousel
status.
Identify Samples
Introduction
Samples may be identified by a Sample ID or by a rack/cup position or both.
Rack and Position Mode and Bar Code Mode setup options affect where the cursor starts within
sample programming and which fields are required to save sample programs. If rack and position
priority is chosen during system setup, the cursor begins at the Rack field. If Bar Code Priority is
chosen, the cursor appears at the Sample ID field, skipping the rack and position assignment. In
both cases, either a rack and position or a Sample ID assignment is required, but both can be
entered.
Refer to CHAPTER 3, System Setup, Bar Code Setup for additional information on setting up sample
identification features.
If a rack has a readable bar code and a manual rack position assignment for the same sample
position, the system verifies that the bar code and the manual assignment match. If there is a
discrepancy, the rack is offloaded and the operator notified with a message. If the bar code and the
manual assignment agree, the rack remains on the carousel and is processed.
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Sample Programming and Processing
Identify Samples
Sample ID
A Sample ID is a unique name used to identify the sample. Sample IDs may be specified with a
maximum of 15 alphanumeric characters. Sample ID is not a required field entry if a rack and
position assignment is made.
1
Select Samples from the menu bar.
2
From the Program Samples screen, select the Sample ID field to type the Sample ID.
Limitations
The instrument stores up to 10,000 unique Sample IDs. When this limit is exceeded, the system
overwrites the oldest sample program. Duplicate Sample IDs are not allowed. If Sample IDs are
reused by the laboratory, set the Maximum Sample Program Age feature to help alert you to
conflicts. Refer to CHAPTER 3, System Setup Options, Maximum Sample Program Age.
WARNING
If your LIS or normal workflow requires the reuse of sample IDs, the sample
programming should be cleared from the DxC at a time interval that is less than
the shortest time of sample ID reuse. The DxC over-write feature is not sufficient
for successfully reusing sample IDs. If this warning is not followed, results from
the new request are merged with tests from incomplete samples that previously
used that ID. In addition, patient demographics at the instrument are from the
previous use of the sample ID. Since demographics are not uploaded from the
instrument, it is possible for these merged results to be uploaded to the LIS which
would contain the current demographics.
Valid Characters for Entries
Valid and Invalid characters for entries are listed in the table below:
Table 6.2 Valid and Invalid Entries
Type of Entry
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These are Valid ASCII
Character Codes...
Except for These Invalid Characters and
Character Codes...
Sample ID
33 thru 126
A space and $ , ; * ? [ ] \^ | &
Other
32 thru 175
ASCII Character Codes 44 and 127
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6
Sample Programming and Processing
Sample Programming and Processing
Create Sample IDs
When creating Sample IDs, use a format that distinctly differs from that used for Calibrator IDs. This
prevents the reporting of erroneous results due to calibrators being run as patient samples, or
patient samples run as calibrators.
Examples:
Calibrator Bar Code ID: MULTICAL
Sample Bar Code ID: 0000001
Sample Programming and Processing
Processing Bar Coded Samples
Generally, previous sample programming need not be cleared before placing a bar coded sample on
the instrument. If the lab reuses Sample IDs, previous programming must be cleared.
1
Load tubes in a rack with the bar code labels visible through the slot on the same side of the rack
as the rack bar code label.
2
For closed tube sampling systems:
• Check the top of the validated closed tube for visible blood.
— If blood is present,
·
Clean the cap with a cotton tipped applicator stick.
For non-CTS Systems or tubes not validated for closed tube sampling, remove the cap.
3
For a Routine Sample or if system is in Standby:
• Priority samples should be placed on the autoloader first.
— Place the rack in the autoloader with the rack bar code label to the right and
— Press RUN.
For a STAT Sample:
• If the system is running and there are other racks on the autoloader,
— Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed
in front of the other racks.
— Press RUN.
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Sample Programming and Processing
Sample Programming and Processing
Manually Assigning Rack and Position
It is only necessary to manually assign a rack and position if:
• The system is set up in bar code mode and a sample will not be bar coded,
OR
• A bar code is unreadable by the system.
1
Select Samples from the menu bar.
2
Select Racks F8.
3
Select a rack with an open position.
OR
Type the Rack number.
4
Type the desired manual assignment into the selected rack/position.
5
Select OK to accept the assignment.
OR
Select Cancel to leave assignment screen without saving assignments.
6
Select Program F10 to return to Sample Program screen.
Processing Samples Manually
Manual programming is used when there is no LIS or the LIS is not available. Samples may or may
not be bar coded. The sample is identified by a Sample ID and/or rack and position. The user selects
tests for programming.
The following items require manual programming:
• Samples without bar codes and no sample programming.
• Samples with bar codes and no sample programming.
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6-7
6
Sample Programming and Processing
Sample Programming and Processing
1
Select Samples from the menu bar.
2
Identify samples using the list below:
If the sample has a readable bar code:
• Type the Sample ID.
• If previous programming appears, it may be necessary to clear it.
• If no previous program appears, go to Step 3.
If the sample has no bar code or bar code can not be read:
• Type the Sample ID.
• Type the numbers in the Rack and Pos fields.
3
If the sample is stat, select the STAT check box.
4
Select Sample Type from the pull-down menu.
NOTE The sample type for UDR must be serum, plasma, CSF or urine. Do not use any other sample type.
5
Select Sample Comment from the pull-down menu.
6
To enter Demographics, select Demog F2. Type the information provided and select Next F10 to
return to the Program Sample screen.
7
Select each chemistry and/or select a panel. To access additional chemistries, use the up and
down arrows to move to other pages.
8
Select Next F10.
9
To program additional samples, repeat Steps 2-10.
10 Place the samples into assigned rack positions.
6-8
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Sample Programming and Processing
Sample Programming and Processing
11 For a Routine Sample or if system is in Standby:
• Priority samples should be placed on the autoloader first.
— Place the rack in the autoloader with the rack bar code label to the right and
— Press RUN.
For a STAT Sample:
• If the system is running and there are other racks on the autoloader,
— Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed
in front of the other racks.
— Press RUN.
Add Tests or Rerun a Sample
1
Select Samples from the menu bar.
2
Select Rerun F6.
3
Type the sample ID, rack, or rack and position for rerun. One or more samples can be
programmed to rerun.
4
Select one of the following buttons:
• To add or rerun specific tests press Select. All previous programming is highlighted.
Deselect chemistries that are not to be run. Select Save F10 to accept programming and
exit screen.
• To rerun all completed tests press All.
5
For a Routine Sample or if system is in Standby:
• Priority samples should be placed on the autoloader first.
— Place the rack in the autoloader with the rack bar code label to the right and
— Press RUN.
For a STAT Sample:
• If the system is running and there are other racks on the autoloader,
— Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed
in front of the other racks.
— Press RUN.
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6-9
6
Sample Programming and Processing
Additional Programming Information
Additional Programming Information
Chemistry Identifiers
Color is used to indicate chemistry information.
• The chemistry name appears in red when the chemistry is not runnable. There are two possible
reasons why a chemistry can not be run:
1. The reagent is not loaded or
2. A loaded chemistry has a reagent or calibration status that does not permit it to run.
Refer to the Reagent/Calibration Status screen for the reason the cartridge can not be run.
• A yellow indicator appears when the chemistry is set for manual ORDAC.
• A blue indicator bar turns from gray to blue when a chemistry is selected.
Enter a Dilution Factor
A dilution factor may be entered to be applied to the results of a specified sample by using
Options F3. The dilution factor represents an off-line dilution prepared by the operator. The default
dilution factor is 1X. Each result for the sample are multiplied by the factor. Any final result
generated by the system is multiplied by the factor.
NOTE The dilution factor will remain as part of the sample programming and must be removed if performing
additional testing of the undiluted sample.
Programming a Manual ORDAC
For samples with analytes of known concentration that exceed the analytic range, the manual
ORDAC feature may be selected. ORDAC compensates for extremely high concentrations by taking
either a smaller sample volume or diluting the sample online. Selecting manual ORDAC in Sample
Programming sends the request to run the test in ORDAC the first time it is run, unlike chemistries
selected for Automatic ORDAC (which are run undiluted first and then rerun using ORDAC when
recovery is out of range).
ORDAC is NOT available for uric acid that is run on urine samples.
NOTE All ORDAC results are designated in the instrument code section on the appropriate results report.
IMPORTANT Results which include the "less than" (<) sign are also multiplied. For example, a CRP result
with a sample dilution of 4, that should be reported out as "<0.5", is reported out as "<2.0".
Programming Samples for Serum Index
Specified samples can be programmed for serum index by using Options F3.
6-10
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Sample Programming and Processing
Additional Programming Information
Batch Programming
Batch Programming provides programming of multiple samples with the same chemistries, sample
type, dilution factor, and status. Any Panel, Comment, Demographics, Dilution Factor, Sample Type,
or Chemistry programmed will apply to all sample positions designated within the batch. This
information may be edited at any time on an individual position basis when the batch programming
is completed. Sample identification and description of each sample may be individually entered
later through the Sample Programming function. The Batch Mode is complete when End Batch is
requested or upon exiting the Sample Program screen.
Batch programming in rack and position mode can be performed using the following procedure.
1
Select Samples from the menu bar.
2
Select the tests, sample type, and any other data that is common for all samples in the batch,
including sample options information.
3
Select Batch F4. A list of available racks for batch programming appears. Racks may also be
cleared from this screen.
• To exit batch program, select Cancel.
• To clear racks, continue with Step 4.
• To batch program, continue with Step 5.
4
To clear racks, type the specific rack ID in the Rack field and select Clear. A message appears,
and verifies that all programming for this rack will be deleted.
• Select OK to delete.
OR
• Select Cancel to keep current programming.
Either response will return the screen to the Batch programming screen.
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6
Sample Programming and Processing
Clear Samples
5
A batch may be programmed with Sample IDs only, rack/cup designations only or both, as
follows:
Identification
6
Procedure
Rack/cup with Sample IDs
• Type rack numbers and number of samples desired in
the batch.
• Select OK and type specific Sample IDs.
Sample IDs only
• Select Sample IDs Only.
• Type specific Sample IDs.
• Select Racks F1 to assign specific racks to the IDs or
leave rack/positions empty.
Rack/Pos only
• Type the rack numbers and number of samples desired
in the batch only. Do not type Sample IDs.
To end Sample ID entry and to save the batch programming, select End F10.
NOTE Patient demographics may be entered for a particular Sample ID at any time from the sample
programming screen by typing a Sample ID in the Sample ID field and selecting Demog F2.
Clear Samples
Introduction
When the test program is processed, if all positions are used, the rack is not available for
programming again until it is cleared. Only the programming information is deleted; the results are
stored and are accessible through the recall function using the appropriate recall option.
Calibrator IDs or rack/position assignments are not cleared from within Sample Programming.
Refer to CHAPTER 4, Reagent Load/Calibration, Calibrator Assignment, for information on calibrator
identification.
IMPORTANT When clearing data, to verify exactly what will be cleared, first view the load list for the
intended range of samples. The samples recalled on the load list are identical to the samples that will be
cleared.
6-12
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Sample Programming and Processing
Clear Samples
When to Clear Samples
Samples should be cleared as follows:
If sample programming is complete:
• Clear sample programming.
If a sample ID must be reused:
• Clear that sample ID first.
If a sample rack can not be programmed due to previous programming:
(This occurs when a sample ID does not match, or when a rack number shows previous information.)
• Clear that programming.
Range of Sample IDs
The system retrieves a range of sample IDs in either Alphanumeric or Numeric form. The system
automatically selects one of the two, depending on the type of sample ID entered. These same
methods of retrieval are used for Load List, Clear Samples and Recall.
Sample IDs containing only Numeric Data:
• Samples are listed in numeric order. For example 1, 2, 3, 4...
• Include leading zeros in the Range field. For example, range 1 thru 1000 would not include
sample 0099, but range 0001 thru 1000 would.
Sample IDs containing only Alpha or Alphanumeric Data:
• Samples are listed in dictionary order. For example A, AB, B...
• Numbers come before letters. For example 1, 900, 1A, A...
• Include all characters in the To field. For example, range A thru Z would not include ZEBRA, but
range A thru ZZZZZZZZZZZZZZ would.
IMPORTANT Do not mix a pure numeric entry with an alphanumeric entry. For example, 0 through 1A
deletes all numeric.
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6-13
6
Sample Programming and Processing
Clear Samples
Procedure for Clearing Samples
1
Select Samples from the menu bar.
2
Select Clear F7.
3
Sample may be cleared by Sample ID(s), Rack/Position, or by Date/Time created. Type the
specific criteria for deletion.
IMPORTANT Clearing Rack/Position does not clear programming for sample(s) programmed in those
positions with associated Sample IDs. Sample must still be cleared by Sample ID. However, clearing
by Sample ID does clear rack/position in which the Sample ID was located.
4
Deletion Criteria
Procedure for Sample Clearing
Sample ID
• Type the Sample ID(s) to be cleared. Single and
multiple IDs may be cleared. Use a comma (,) to
separate a list of IDs.
Range of Sample IDs
(Refer to Range of Sample IDs
in this chapter for additional
information.)
• Type the first Sample ID in the From field.
• Type the last Sample ID in the To field.
Time/Date Programs Created
• Type the time and date range of samples to clear.
Rack/Position(s)
• Type the Rack/Position(s) to be cleared. Single
and multiple racks may be entered.
— If only Rack is entered, programming in all
positions in that rack is cleared.
Select OK to continue clearing. A confirmation screen appears.
OR
Select Cancel to retain sample programs.
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CHAPTER 7
Results Recall
Overview
Introduction
Results Recall allows patient and control results to be recalled, reviewed, updated, and printed.
Results can be recalled, viewed, and printed by:
• individual Sample ID or a list of Sample IDs
• rack and position
• Patient ID or
• run date and time.
Limitations
The system keeps a maximum of 150,000 results and 10,000 sample programs. When these limits are
exceeded, the system chronologically overwrites existing results.
When a sample program is cleared, results cannot be recalled by Sample ID. Results may still be
recalled by other demographic information.
To avoid retrieving inconsistent sample data, recall results using Sample ID or verify correct Sample
ID when recalling by rack and position. Results for the last sample run in a specific rack/cup
position will be recalled. Results for the new sample is available for recall only after the system
begins to run the new assignment.
CAUTION
If a newly assigned sample that has not been run is recalled, the Results for the
previous sample run in that position is shown or transmitted.
When using the Results Recall feature, do not leave any samples with tests In
Progress on the screen. This prevents the rack from being removed from the
system and a printout of the Results from being produced.
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7-1
Results Recall
Recall Results by Sample ID
Recall Results by Sample ID
Results can be recalled by an individual Sample ID and/or by a range of Sample IDs.
Individual Sample IDs and/or a range of Sample IDs can be entered. Results may be reviewed and/
or sent to the host. Follow the steps below to enter Sample IDs for recall.
1
Select Results from the menu bar.
2
To input an individual Sample ID:
• Type the Sample ID desired for recall in the Sample ID field.
• To input a range of Sample IDs:
— Type the Sample ID at the beginning of the range in the From field.
— Press (Tab) .
— Type the Sample ID at the end of the range in the To field.
— Press (Enter) .
• To input, select a function button from the bottom of the screen to select a desired output
option:
— Results F1 - to view results on the screen.
— Sum F7 - to send statistical summary to printer.
— Host F8 - to send results to the host.
— Print F10 - to send results to a printer.
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Results Recall
Recall Results by Rack and Position
Recall Results by Rack and Position
1
Select Results from the menu bar.
2
Type the rack number(s) (1–999) for recall in the Rack field from the Recall Results By dialog
box.
Numbers can be separated by a comma to define a series and/or by a dash to define a range
(Example: 1,2, 5–8).
• If one rack number is entered,
— Press (Tab) to access the Pos(s) field.
— Type the position numbers desired for recall (1–4). Numbers can be separated by a
comma to define a series and/or by a dash to define a range.
• If one rack number and no position number is entered, all positions on the rack are
automatically selected.
• If more than one rack number is entered,
— All positions on each rack are automatically selected.
— The Pos(s) field cannot be accessed.
3
Select a function button from the bottom of the screen to select a desired output option.
•
Results F1 - to view results on the screen.
•
Sum F7 - to send statistical summary to printer.
•
Host F8 - to send results to the host.
•
Print F10 - to send results to a printer.
For additional information, refer to Display Recalled Results, Print Recalled Results, and Send
Results to the Host in this chapter.
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7
Results Recall
Recall Results by Patient ID
Recall Results by Patient ID
1
Select Results from the menu bar.
2
Type the Patient ID in the Patient ID field (a maximum of 15 alphanumeric characters).
Only one Patient ID may be requested at a time.
3
Select a function button from the bottom of the screen to select a desired output option.
•
Results F1 - to view results on the screen.
•
Sum F7 - to send statistical summary to printer.
•
Host F8 - to send results to the host.
•
Print F10 - to send results to a printer.
Recall Results by Run Date/Time
7-4
1
Select Results from the menu bar.
2
From the Recall Results By dialog box, type the desired date and time ranges in the From fields
and To fields.
3
Select a function button from the bottom of the screen to select a desired output option.
•
Results F1 - to view results on the screen.
•
Sum F7 - to send statistical summary to printer.
•
Host F8 - to send results to the host.
•
Print F10 - to send results to a printer.
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Results Recall
Display Recalled Results
Table 7.1 Date and Time Formats with Recall Results
Field
Entries
Notes
Date
1–12 mm
1–31 dd
0–99 yy
• An entry in the From field is required.
• If only a From date is entered, the results are recalled for that
date.
Time
(12-hour format)
1–12 hh
0–59 mm
AM/PM
• The time format is defined in Setup as 12-hour or 24-hour.
• The 12-hour default is AM.
Time
(24-hour format)
0–23 hh
0–59 mm
• If no time interval is entered, the results are recalled for the
Date(s) entered in 24-hour interval(s).
Display Recalled Results
All recalled results may be viewed on the screen.
1
From the Recall Results By dialog box, select the results to be viewed, as previously described in
this chapter.
2
Select Results F1 to view requested samples.
3
Press (Page Up) or (Page Down) to view additional pages of the same sample.
4
If there are tests running, Recall F2 is available.
• Select Recall F2 to update the sample on the screen with new results since the sample was
first shown.
• Select ABS F3 to view the Absorbance versus Time plot.
OR
• Select Edit F4 to edit.
OR
• Select Host F6 to send results to the host.
OR
• Select Print F7 to print.
OR
• Select Prev F8 to view a previously shown sample.
OR
• Select Next F9 to view other samples if more than one sample was recalled.
OR
• Select Done F10 when done.
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7
Results Recall
Edit Critical Rerun Result
Edit Critical Rerun Result
Introduction
When a sample is rerun, the two results are shown in the Recall Results screen. The first result is
always listed at the top and the rerun result is listed under the first result. The operator can delete
one of the results and keep the other result. Only one of the two results can be deleted.
For Critical Rerun Result with DAT samples, printed results have a positive or negative flag for all
results. On the screen, the first result is flagged positive or negative. The second (rerun) result,
however, has no interpretation; only a rate and a critical rerun remark are shown. Use the printed
report to compare the two interpretations. If they are both positive or both negative, delete the
second result.
Delete Critical Rerun Result
Follow the steps below to delete one of the two results of a sample which was rerun with Critical
Rerun Result.
1
From the Recall Results By dialog box, select the results to be viewed, as previously described in
this chapter.
2
Select Results F1 to view requested samples.
3
Press (Page Up) or (Page Down) to view additional pages of the same sample.
4
Locate the desired sample that has two results. Select one of its results to delete.
5
Select Edit F4 to delete the selected result.
6
Select Yes to delete the result.
OR
Select No to not delete the result and return to the Recall Results dialog box.
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Results Recall
Print Recalled Results
7
If Yes was selected in Step 6, type the password (if secured) and ID initials.
Select OK to return to the Recall Results dialog box with the result deleted.
OR
Select Cancel to return to the Recall Results dialog box and not delete the result.
NOTE The deleted result with the initials of the operator are sent to an Event Log called Deleted Results.
8
Select Prev F8 to view a previously shown sample.
OR
Select Next F9 to view other samples if more than one sample was recalled.
OR
Select Done F10 when completed.
Print Recalled Results
All recalled results may be printed.
1
Select Results from the menu bar.
2
To print using the default report format:
• Go to Step 4.
To print using Patient Multi-Sample report format
• Continue with Step 3.
3
If Patient Multi-Sample Report box is selected, input specific Patient ID. Select Print F10.
Select samples to be compiled into report.
All selected Patient Results are compiled into a single report.
4
A13914AF
From the Recall Results By dialog box, select the results to be viewed, as described previously in
this chapter.
7-7
7
Results Recall
Send Results to the Host
5
Select Print F10. The selected results are printed in the format selected in System Setup.
NOTE Multipatient Sample reports print a maximum of 15 chemistry results and 5 special calculation results
per page. Additional results print on subsequent pages.
Send Results to the Host
Introduction
Results may be sent to the host in two ways:
• Recall and send whole groups of data.
• Recall and send individual sample data.
Send Data
1
Select Results from the menu bar.
2
To send whole groups of data:
• Type the range of racks, Sample ID, patient ID or run date/time.
• Select Host F8.
To send individual sample data:
• Type the Sample ID, patient ID, run date/time or racks/position.
• Select Host F8.
Absorbance Versus Time
To get data to help troubleshoot completed chemistry results, use the Absorbance versus Time
feature.
Recall Data
1
7-8
Recall the results of the desired sample (use any of the Results Recall criteria described in the
previous sections).
A13914AF
Results Recall
Absorbance Versus Time
2
When the results of the desired sample appear, select the desired chemistry(ies). Selected
chemistries are highlighted next to the chemistry name.
3
Select ABS F3.
NOTE The Absorbance vs. Time Plot is shown for the first selected chemistry.
4
To see the Absorbance Plot Summary Data:
• Select the down arrow.
To see the Absorbance vs. Time Table:
• Select the Table tab.
5
To output a file to a diskette:
• Select Done to exit the screen.
• Select Disk F1.
To output Absorbance vs. Time Plot and Absorbance vs. Time Table to a printer:
• Select Both.
To output either Absorbance vs. Time Plot or Absorbance vs. Time Table to a printer, depending
on which is on the screen:
• Use the Plot or Table tab at top of screen to go from the plot to the table.
• Select Print.
6
To output the plot for the next chemistry:
• Select Next.
7
To output the plot for the previous chemistry:
• Select Prev.
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7
Results Recall
Statistical Summary Report
Statistical Summary Report
Introduction
The Statistical Summary Report feature allows the user to select a range of samples that will
produce a calculated mean, Standard Deviation, and Coefficient of Variation for a group of selected
samples. The information is automatically printed out on a report. This can be valuable when
assessing the performance of the system, or as an aid in establishing population variances.
Additional Information
The maximum number of samples that may be recalled is 100. If more than 100 samples are recalled
the instrument will:
• Show "Exceeds maximum limit. Not all samples will print."
• Not print statistics for all samples.
Display Statistical Summary
1
Select Results from the menu bar.
2
Type the range of desired results (use any of the Results Recall criteria described in the Send
Results to the Host section).
NOTE The maximum range of samples that can be recalled is set to 100. If there are more than 100
samples in the range, the following message appears:
"Exceeds maximum limit. Not all samples will print."
3
Select Sum F7 from the Recall Results By dialog box.
A Statistical Summary Report is printed.
7-10
A13914AF
CHAPTER 8
User Defined Reagents
Overview
The user may define up to 100 chemistries on the UniCel DxC 600/800 using an endpoint or rate, and
calibrated or non-calibrated methodology. A set of parameters must be defined which fully
characterizes an analyte. When the parameters are defined, they are stored in memory according
to the test name designated in System Setup. Chemistries can then be configured on the test
selection menu for programming along with the Beckman Coulter-defined chemistries. When
configured, quality control, reference ranges, and special calculations may be used with these
configured chemistries.
In addition, up to 10 of the 100 user defined chemistries may be configured with the Expanded User
Defined Chemistry feature. Refer to the end of this chapter for further information.
NOTE The sample type for UDR must be serum, plasma, CSF or urine. Do not use any other sample type.
Requirements and Precautions
Minimum Requirements for Operation
The following parameters must be defined to use the User-Defined Reagent feature.
• chem name
• primary wavelength
• secondary wavelength (except for the LPIA Module)
• reagent dispense volume
• sample volume
• blank start and blank end read times
• reaction start and reaction end read times.
If additional parameters are defined, Exit Check criteria must be passed. Refer to Exit Check Criteria
in this chapter.
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8-1
User Defined Reagents
Requirements and Precautions
User Defined Reagent Cartridges
The user-defined reagent is placed in generic, non-bar code labeled, three-compartment cartridges
that are loaded onto the system manually. These cartridges are available in a box of 12 (PN 442835).
The label on the cartridge should be marked with the reagent name and expiration date. The
maximum and minimum fill volumes, required to allow for accurate level sensing, are indicated in
the table below.
Table 8.1 Fill Volumes for Accurate Level Sensing
Compartment A
Compartment B
Compartment C
Maximum Fill Volume
110 mL
18 mL
4 mL
Minimum Fill Volume
6 mL
1 mL
0.3 mL
IMPORTANT Since Beckman Coulter does not manufacture or otherwise control the reagents that may be
used in user defined reagent cartridges, Beckman Coulter makes no warranty whatsoever with respect
to such reagent's performance (including test results), their effect on the system or required system
maintenance or the frequency thereof, or their effect on operator safety. User assumes full responsibility
for use of the proper test protocol and test result generation for the reagent(s) selected by the user and
for any errors or omissions associated therewith. BECKMAN COULTER EXPRESSLY DISCLAIMS ALL
WARRANTIES WITH RESPECT TO THIS PRODUCT WHETHER EXPRESS OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
IMPORTANT Non-Beckman Coulter reagents, calibrators, and controls can contain components, not listed
on the insert, which may carry over into the system causing chemical or spectral interference. This
carryover could adversely affect results on a properly performing system. Manufacturers of user-defined
reagents should be contacted for disclosure of potentially interfering substances, such as preservatives.
8-2
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User Defined Reagents
User-Defined Reagent Setup
User-Defined Reagent Setup
Defining a User-Defined Reagent
1
Select Setup from the menu bar.
2
Select 15 User-Defined Chemistries.
3
Select the Number to be defined.
OR
Type a number in the Option Number field and press (Enter) .
4
Select Define F1.
5
Type information for the user-defined reagent as defined on the following screens:
• Chemistry Parameters
• Processing Parameters
• Error Detection Limits
6
Select Restore F1 to restore the default parameters.
OR
Select Cancel F9 to cancel and return to previous screen.
OR
Select Done F10 to save and exit.
• If an area is incomplete or incorrect, a flag appears indicating the error.
— Perform the appropriate action to continue.
— Refer to Exit Check Criteria in this chapter for additional information.
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8-3
8
User Defined Reagents
Chemistry Parameters
Edit a User-Defined Reagent
User-defined reagent parameters may be edited if:
• The reagent is not on board.
OR
• The reagent is loaded on board and the system is in Standby or Stopped. To modify the number
of calibrations used, the calibrator assignments must be removed.
Chemistry Parameters
Define a Chemistry Test Name
A test name cannot begin with a numeric entry or be defined the same as an existing chemistry test
name. The test name is stored and retrieved in upper case letters only. The designated test name
is used as the chemistry code as described in CHAPTER 4, Tables/Codes, in the UniCel DxC Synchron
Clinical Systems Host Interface Specifications manual.
Table 8.2 Allowable Entries for a Chemistry Test Name
A maximum of four alphanumeric characters, including "-".
The first character MUST be an alphabetical character.
Reaction Type
Refer to CHAPTER 2, Theory of Operation, Cartridge Chemistry: Principles of Measurement in the
UniCel DxC Synchron Clinical Systems Reference Manual for a detailed explanation of each type.
Table 8.3 Reaction Type Options
Reaction Type
8-4
Description
Endpoint 1
Blank absorbance is not subtracted from Reaction 1 absorbance.
Endpoint 2
Blank absorbance is subtracted from Reaction 1 absorbance.
Endpoint 3
Blank absorbance is volume corrected and then subtracted from Reaction 1
absorbance.
Endpoint 4
Blank absorbance is subtracted from Reaction 2 absorbance.
Endpoint 5
Reaction 1 absorbance is subtracted from Reaction 2 absorbance.
Rate 1
Blank rate is not subtracted from Reaction 1 rate.
Rate 2
Blank rate is subtracted from Reaction 1 rate.
Rate 3
Blank rate is volume corrected and then subtracted from Reaction 1 rate.
Rate 4
Blank rate is subtracted from Reaction 2 rate.
Rate 5
Reaction 1 rate is subtracted from Reaction 2 rate.
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User Defined Reagents
Chemistry Parameters
Units
Changing previously defined units for a user defined reagent is not allowed if the chemistry is
included in a current control definition. In addition, changing units invalidates recalled results and
deletes associated reference ranges.
Table 8.4 Options for Units
1. mg/dL
11. μg/mL
21. IU/mL
31. negative
41. mg/mL
2. mg/L
12. ng/mL
22. U/mL
32. pg/mL
42. ng/L
3. g/dL
13. μg/dL
23. Rate
33. pg/dL
43. RLU
4. g/L
14. μg/L
24. ng/dL
34. pmol/L
44. S/CO
5. mmol/L
15. nmol/L
25. μIU/mL
35. %Uptake
45. AU/mL
6. μmol/L
16. U/L
26. mIU/mL
36. %GHb
46. AU/L
7. mEq/L
17. other
27. Ku/L
37. %A1c
47. mAU/L
8. nKat/L
18. %
28. nIU/dL
38. GPL
48. mAUL/mL
9. μKat/L
19. mA
29. mIU/L
39. MPL
49. (i) SI
10. IU/L
20. mA/min
30. positive
40. APL
50. % Supp
Precision
Precision specifies the number of decimal places for reporting results.
Table 8.5 Options for Precision
X
X.X
X.XX
X.XXX
Reaction Direction
A positive reaction direction indicates increasing absorbance with time. A negative reaction
direction indicates decreasing absorbance with time.
Table 8.6 Options for Reaction Direction
Positive
Negative
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8-5
8
User Defined Reagents
Chemistry Parameters
Math Model
Refer to CHAPTER 2, Theory of Operation, Modular Chemistry: Calibration Theory, in the UniCel DxC
Synchron Clinical Systems Reference Manual for a detailed explanation of each selection.
Table 8.7 Options for Math Models
Linear
Math Model 1 - 4 Parameter Log-logit function
Math Model 2 - 5 Parameter Logit function
Math Model 3 - 5 Parameter Exponential function
Math Model 8 - Alternative to Model 2, 5 Parameter Logit function
Math Model 9 - Extension to Model 1, 4 Parameter Log-logit function
DAT Math Model
Double Inflection Model DP4
Primary Wavelength
The primary wavelength is used to measure the desired chromophore.
Table 8.8 Options for Primary Wavelengths for the Photometer
340, 380, 410, 470, 520, 560, 600, 650, 670, 700 or 940 nma
a. Refer to Expanded User Defined Chemistry Feature for more information.
Secondary Wavelength
The secondary wavelength is used for flash correction of the primary absorbance values. The
primary and secondary wavelength cannot be equal.
Table 8.9 Options for Secondary Wavelengths
340, 380, 410, 470, 520, 560, 600, 650, 670, or 700 nm
8-6
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User Defined Reagents
Chemistry Parameters
Calculation Factor
A calculation factor should be entered if no calibrators are defined. If a calculation factor is not
defined, the system will not accept the default value of 0, and the user must type 1. For downgoing
reactions, the entry must be a negative number. Additional slope and offset adjustments may be
made at the Reagent Status/Calibration Status screen.
For calculating the appropriate factor for rate chemistries, a derivation of the Beer's Law formula
as applied to bichromatic chemistries can be used as follows:
T.V.
S.V.
×
1000
0.5(e1 – e2)
E014426L.EPS
where:
e1
=
The extinction coefficient of the chromophore at the primary wavelength.
e2
=
The extinction coefficient of the chromophore at the secondary wavelength.
Extinction coefficients for the chromophore MUST be obtained from the reagent manufacturer or
determined experimentally (refer to Determination of Extinction Coefficients in this chapter).
T.V.
=
Total reaction volume (sample plus reagent, μL)
S.V.
=
Sample volume (μL)
0.5
=
Cuvette pathlength (cm)
1000
=
Units correction factor
Table 8.10 Allowable Entries for a Calculation Factor
-99999.000 to 99999.000, except 0
Number of Calibrators
• If no calibrators are used, type 0.
— A linear math model allows no more than two calibrators.
— A non-linear math model requires five or more calibrators.
• If two or more calibrators are used, span values are shown.
• If five or more calibrators are used, recovery and sensitivity statistics are also shown.
Table 8.11 Options for the Number of Calibrators
0, 1, 2, 3, 5, or 6
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8
User Defined Reagents
Processing Parameters
Calibrator Values
The values must be entered in the same units as specified in the Units parameter. Type the values
for the number of calibrators stated above in ascending order (low to high). This facilitates proper
placement of the calibration samples on the rack, since the load list does not denote the cup order
of the user-defined calibrators. All other values are disregarded.
Table 8.12 Allowable Entries for the Calibrator Values
-9999.000 to 9999.000
Calibration Time Limit
Calibration time limit is the number of hours the chemistry can be run before recalibration is
required. If this time is exceeded, the chemistry cannot be run. This parameter is not applicable if
the number of calibrators is zero. (Refer to CHAPTER 4, Reagent Load/Calibration for calibration
procedures.)
IMPORTANT If the UDR is removed from the instrument, calibration is lost. To enable Cal Save, refer to
Expanded User Defined Chemistry Feature in this chapter.
Table 8.13 Allowable Entries for the Calibration Time Limit
1 to 336 hours
Processing Parameters
First Inject: Component
The First Inject component designates the compartment of the cartridge which will be pipetted
first.
Table 8.14 Options for the First Inject Component
A, B, or C
First Inject: Dispense Volume
The combined volume of all inject reagents must be between 200 and 327 μL. If Second Inject and
Third Inject reagents are not used, the minimum volume for First Inject is 200 μL.
Table 8.15 Allowable Entries for the First Inject Dispense Volume
125 to 327 μL
8-8
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User Defined Reagents
Processing Parameters
Second Inject: Component
The Second Inject component designates the compartment of the cartridge which will be pipetted
second. If Second Inject is not used, the default compartment selection is None and should not be
modified.
Table 8.16 Options for the Second Inject Component
None, A, B, or C
Second Inject: Dispense Volume
The combined volume of all inject reagents must be between 200 μL and 327 μL.
Table 8.17 Allowable Entries for the Second Inject Dispense Volume
6 to 75 μL
Second Inject: Add Time
Add Time programs the reagent dispense time into the cuvette. Refer to Figure 8.1.
• The Second Inject may be added at the same time as First Inject or a minimum of 8 seconds after
sample has been pipetted. (Time is entered in increments of 1 second; however, the reagent is
added at the 8-second interval closest to the time defined. Sample addition occurs at 1 second.)
• A positive number indicates a Second Inject reagent component is added after sample add.
• An add time value of -180 dispenses reagent at the same time as First Inject reagent component.
Table 8.18 Allowable Entries for Add Time for the Second Inject
-180, 9 to 738 seconds
IMPORTANT When defining a UDR, the second inject is automatically moved to the third inject if only the
first and second injects are defined.
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8-9
8
User Defined Reagents
Processing Parameters
Figure 8.1 Timing Chart
Cuvette Wash
3 to 6 minutes
Sample Inject
Primary Reagent Fill
Cuvette Wash Completed
DxC 600/800 Timing Chart
TIME (SECONDS)
Reagent Blank Read Window
Second Inject Add Time (T = -180, 9 to 738)
Third Inject Add Time (T = -172, 9 to 738)
Reaction Read Windows
T = -180
T = -172
T=0
T=9
T = 738
E011407L.EPS
Third Inject: Component
This designates the compartment of the cartridge which will be pipetted third. If Third Inject is not
used, the default compartment selection is None and should not be modified.
Table 8.19 Options for the Third Inject Component
None, A, B, or C
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User Defined Reagents
Processing Parameters
Third Inject: Dispense Volume
The combined volume of all inject reagents must be between 200 and 327 μL.
Table 8.20 Options for the Third Inject Dispense Volume
6 to 75 μL
Third Inject: Add Time
Add Time programs the reagent dispense time into the cuvette.
• The Third Inject may be added a minimum of 8 seconds after reagent(s) and/or sample have
been pipetted. (Time is entered in increments of 1 second; however, the reagent is added at the
8-second interval closest to the time defined. Sample addition occurs at 1 second.)
• A positive number indicates Third Inject reagent component is added after sample add.
• Third Inject add time must be greater than Second Inject add time.
Table 8.21 Allowable Entries for Add Time for the Third Inject
-172, 9 to 738 seconds
Sample Volume
Total volume of sample and reagents A, B, and C cannot exceed 330 μL. Volume is specified in
increments of 1 μL.
Table 8.22 Allowable Entries for Sample Volume
3 to 40 μL
Blank Read Times
Blank read times indicate when the blank absorbance is to be read.
• Time -180 to -1 is a reagent blank.
• Time 1 is when sample is added to the cuvette.
• Time 1 to 720 is a sample blank.
• Time is entered in 1-second intervals, but readings begin and end at the closest 8-second
interval.
• Read times should not coincide with a pipetting cycle.
Table 8.23 Blank Read Times
Allowable Entry
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Start Read
-180 to 1704 seconds, except 0
End Read
-180 to 1720 seconds, except 0
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8
User Defined Reagents
Processing Parameters
Initial Read Times
The initial read time is defined in the initial read time window for the rate or end point
measurement. The end time must be at least 8 seconds greater than the start time.
Table 8.24 Initial Read Times
Allowable Entry
Start Read
1 to 1704 seconds
End Read
9 to 1720 seconds
If the initial read times are not entered, the default values are defined as follows:
• Reaction starts with sample addition (sample is added at cycle 1). Initial read starts at cycle 1
and ends at cycle 2.
• Reaction starts with trigger reagent (trigger reagent is added at cycle N). The initial read starts
at cycle N and ends at cycle N + 1.
Reaction Read Times
Reaction read times indicate when the reaction is to be read.
• Time 1 is when sample has been added to the cuvette.
• Time is entered in 1-second intervals, but readings begin at the next 8-second interval.
Table 8.25 Reaction Read Times
Allowable Entries
Single Cycle Test
Double Cycle Testa
Start Read
1 to 1704 seconds
1 to 1604 seconds
End Read
1 to 1720 seconds
721 to 1620 seconds
a. Overall system throughput is decreased. Cuvettes next to the test cuvette are left empty to prevent the test cuvette from
being washed in the first cycle.
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User Defined Reagents
Error Detection Limits
Usable Result Range
Usable result range specifies the analytical range of the reagent. Results are suppressed and flagged
as out-of-instrument range low (OIR-LO) or out-of-instrument range high (OIR-HI), respectively, if
these ranges are exceeded.
If any parameter is edited, the instrument automatically changes the Reportable Range information
from System Setup to the Usable Range defined for the UDR. The Reportable Range must be reentered if the values are different from the Usable Range.
Table 8.26 Usable Result Range
Allowable Entry
Lower Limit
0.000 to 99999.999
Upper Limit
0.000 to 99999.999
Error Detection Limits
Reagent Blank (Absorbance or Rate)
Reagent blank specifies the minimum and maximum absorbance or rate (method dependent) for
the reagent blank measured during the blank read window. If these values are exceeded, the results
are suppressed and flagged as blank absorbance/rate high (BL ABS HI or BL RATE HI) or blank
absorbance/rate low (BL ABS LO or BL RATE LO).
Mean deviation is a measure of noise in the read window.
Table 8.27 Allowable Entries for Reagent Blank
Low Limit
-1.500 to 2.200
High Limit
-1.500 to 2.200
Mean Deviation
0.000 to 2.200
Reaction (Absorbance or Rate)
Reaction specifies the minimum and maximum absorbance or rate (method dependent) measured
during the reaction read window.
• For upgoing rate or endpoint reactions, if the reaction absorbance is less than the Low Limit
then results are suppressed and flagged as RX ABS LO. Likewise, if the High Limit is exceeded,
the result is suppressed and flagged RX ABS HI.
• For downgoing rate methods, the Low Limit indicates the maximum rate observed during the
reaction read window.
• For downgoing endpoint methods, the Low Limit indicates the maximum absorbance observed
during the reaction read window.
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8
User Defined Reagents
Error Detection Limits
Mean deviation is a measure of noise in the read window.
Table 8.28 Allowable Entries for Reaction
Low Limit
-1.500 to 2.200
High Limit
-1.500 to 2.200
Mean Deviation
0.000 to 2.200
Initial Rate High and Substrate Depletion
The initial rate parameter specifies maximum rate of absorbance change measured within the first
cycle after the last component (sample or reagent) is added. When this value is exceeded, results
are suppressed and flagged Initial Rate High (INIT RATE HI).
The delta absorbance specifies the maximum acceptable difference between the Reaction HIGH
ABS, measured just after sample or starter reagent addition, and the final absorbance measured at
the end of the reaction read window. When this value is exceeded, results are suppressed and
flagged Substrate Depletion (SUB DEPL).
Table 8.29 Allowable Entries for Initial Rate and Delta Absorbance
Initial Ratea
-99.999 to 99.999
Delta Abs
0.000 to 2.200
a. For downgoing reactions, the initial rate should be a negative number.
Multipoint Spans
Multipoint span limits specify the allowable difference in absorbance or rate between respective
multipoint calibrator levels:
• 1 and 2
• 2 and 3
• 3 and 4
• 4 and 5
• 5 and 6
• 6 and 1
Values are only shown for the number of calibrators specified under "# of Calibrators". A change in
calibrator number resets the spans to zero (0.000).
The sign (positive or negative) of multipoint spans are dependent upon the direction of change
between two successive calibrators. For example, if the response for Cal 2 data < Cal 1 data, the
multipoint span must be negative.
Table 8.30 Allowable Entries for Multipoint Span Limits
-1.500 to 2.200
8-14
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User Defined Reagents
Wavelength Selection
IMPORTANT The system may accept incorrect calibration data if:
•
multipoint span values are not entered during UDR setup,
•
span values of 0 are entered, and/or
•
the samples are not loaded correctly during the run.
Wavelength Selection
Introduction
The UniCel DxC 600/800 provides a selection of ten wavelengths ranging throughout the UV-visible
spectral region from which to measure the absorbance of a desired analyte. These are 340, 380, 410,
470, 520, 560, 600, 650, 670, and 700 nm. In order to run a user-defined reagent, two wavelengths are
required: the primary or analysis wavelength, and the secondary or reference wavelength.
Primary Wavelength Selection
Knowledge of the spectral curve of the chromophore of interest facilitates proper selection of
wavelengths. The primary wavelength is selected based on the maximum absorbance peak
obtained using the desired chromophore. The secondary wavelength, which will vary depending on
the properties of the chromophore, is used to compensate for variations in the light intensity each
time the xenon lamp is flashed. For a detailed description of the principles of flash correction, refer
to CHAPTER 2, Theory of Operation in the UniCel DxC Synchron Clinical Systems Reference Manual.
Secondary Wavelength Selection
To select the optimal secondary wavelength for a given analyte, the following criteria are
recommended:
• The secondary wavelength should be as close to the primary wavelength as possible without
overlapping the spectral curve of the desired chromophore. The secondary reference
wavelength should be near the base of the analytical absorption curve. If the wavelength
selected resides on the spectral curve, a loss of sensitivity may result.
• In order to minimize any optical interference due to the presence of another absorption curve,
the selection of the secondary wavelength will depend on the location of the other curve in
relation to the primary wavelength of the desired chromophore. If the second curve overlaps
the primary wavelength, there may be an interference; however, proper selection of the
secondary wavelength can function as a "bichromatic" measurement effectively minimizing or
eliminating absorbance due to the interfering substance. In this instance, the secondary
wavelength should be on the interfering curve at or near a point where the absorbance is at the
same level as the crossover absorbance on the primary wavelength. If, however, the second
curve does not interfere at the primary wavelength, the secondary wavelength should not be
selected within the area encompassed by that curve.
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8
User Defined Reagents
Determination of Extinction Coefficients
•
The shortest distance between the two selected wavelengths (without overlapping the spectral
curve) optimizes the flash characteristics of the lamp, providing better precision of the
absorbance data. It is strongly recommended that precision and correlation data be
accumulated to verify proper selection of the wavelengths as well as all of the defined
parameters.
Summary
• A secondary wavelength closer to the primary wavelength reduces noise and increases
accuracy.
• Obtaining the maximum absorbance difference increases sensitivity.
• Avoid secondary wavelengths with peak spectral interferences within the primary spectral
curve.
• Select a secondary wavelength that produces a net absorbance that is close to the net
absorbance of the primary wavelength.
Determination of Extinction Coefficients
Introduction
In general, there are two ways to determine the molar absorptivity or extinction coefficient "e" for
a given chemistry at each of the wavelengths required for analysis.
Option 1
Prepare a stock, standard solution of the chromophore. From this stock solution, prepare a working
standard solution at the same molar concentration recommended by the reagent manufacturer.
Obtain absorbance values on this working standard solution within a narrow-bandpass, manual
spectrophotometer which uses 1 cm pathlength cuvettes. Calculate the extinction coefficient for
the appropriate wavelength as follows:
e=
Absorbance of chromophore
Concentration of standard solution (mmol / L) × pathlength
E014427L.EPS
This method may only be used when the chromophore is measurable in a stable form. When the
chromophore is not attainable in a stable form and may only be measured in a dynamic state, the
second method of determining extinction coefficients is suggested. For additional information,
refer to Textbook of Clinical Chemistry, Norbert W. Tietz, 1999.
8-16
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User Defined Reagents
Exit Check Criteria
Option 2
Prepare the reagent according to the manufacturer’s instructions. With a manual
spectrophotometer or automated instrument, obtain the delta absorbance per minute on at least
ten replicates of a normal or high normal sample at each of the appropriate wavelengths selected.
Average the delta absorbance per minute obtained at each wavelength. The extinction coefficient
at the secondary wavelength may be calculated by use of a factor or correction coefficient (R)
derived from the ratio of the delta absorbance per minute at the secondary and primary
wavelengths. The following formula may be used:
e2 = e1 × R
where:
R =
e2
=
Extinction coefficient at the secondary wavelength
e1
=
Extinction coefficient at the primary wavelength a
Delta absorbance / minute at secondary wavelength
Delta absorbance / minute at primary wavelength
E014428L.EPS
a. The extinction coefficient of the chromophore at the primary wavelength is usually specified by the reagent manufacturer.
Exit Check Criteria
Introduction
When preparing to save a chemistry protocol after editing, the parameters are checked for
correctness, completeness, and consistency. Chemistry protocols that fail any Exit Check criteria
are not allowed to run. The following requirements specify the Exit Check criteria and parameters
presented for modification when the user elects to correct detected protocol errors.
Wavelengths
• The primary wavelength must not be None.
• The secondary wavelength must not be None.
• The primary wavelength must be different from the secondary wavelength.
Calibration
• The calibration time limit must be greater than zero hours if the number of calibrator levels is
greater than zero.
• The sequence of calibrators must be in ascending target value order.
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8
User Defined Reagents
Exit Check Criteria
• Calibrator target values must be unique -- no two calibrator levels can have the same analyte
target value (setpoint).
• Models 1, 2, 3, 8 & 9 and DAT do not support negative setpoints.
• If the math model is either Model 1 or Model 9, the number of calibrators must be five or six
levels only.
• If the math model is Model 2, Model 3, or Model 8, the number of calibrators must be exactly six
levels.
• If the math model is DAT, the number of calibrators must be exactly three levels. The middle
level defines the cutoff between positive and negative. The lowest and highest levels are used
to measure the reagent sensitivity.
• If the math model has been specified as LINEAR, the number of cal levels must be 0, 1 or 2.
• If the math model is DAT, the result units must be mA/min (rate) or mA (absorbance).
Blanking
• The reagent blank end time must exceed the reagent blank start time by a minimum of one
processing cycle.
• The blank absorbance high limit must be greater than the blank absorbance low limit.
• The rate low limit cannot exceed the high limit for positive reaction direction chemistries.
• The rate low limit must exceed the high limit for negative reaction direction chemistries.
Measurement
• The reaction end-read time must exceed the reaction start-read time by a minimum of one
processing cycle.
• The reaction absorbance high limit must be greater than the reaction absorbance low limit.
• The usable range upper limit must be greater than the usable range lower limit.
Volumes
• If a reagent injection (first, second and third) specifies a reagent component to be dispensed,
component A, B or C is specified, the corresponding dispense volume must be greater than zero.
Reagent volumes of 0 μL indicate a volume that is not set.
• The sample volume must be greater than 0 μL.
• The sum of all reagent volumes added prior to the reagent blank read must be greater or equal
to 200 μL.
• The sum of sample volume and all reagent volumes must not exceed 330 μL.
• The first, second and third reagent inject components must be from different compartments of
the reagent package.
• The first reagent inject must be from a larger reagent compartment than either the second or
third reagent inject. The relative capacities of the reagent package compartments are:
A > B > C.
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User Defined Reagents
User Defined Reagent Removal
• If a single trigger is defined, it should be defined in the third inject column. If it is defined in
the second inject column, the system transfers the information to the third inject column upon
exit.
User Defined Reagent Removal
Remove a User Defined Reagent
1
Remove UDR reagent cartridge from system.
2
Delete UDR information from the following areas:
• reference ranges
• calibration assignments
• sample programming and
• quality control.
3
Select Setup from the menu bar.
4
Select 2 Chem Config/Sample Type.
5
Select the chemistry to be deleted.
6
Select Delete F6 to remove the UDR from the chemistry menu.
7
Select Setup from the menu bar.
8
Select 15 User-Defined Chemistries.
9
Select the Option No. of the chemistry to be deleted.
10 Select Delete F2.
A user defined reagent must be deconfigured from the chemistry menu prior to removal.
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8-19
8
User Defined Reagents
Expanded User Defined Chemistry Feature
Expanded User Defined Chemistry Feature
Introduction
The Expanded User Defined Chemistry (or UDR for User Defined Reagent) feature adds any or all of
the following options for up to 10 UDR chemistries:
• Retain calibration data when a cartridge is removed from the instrument.
• ORDAC capability.
• Onboard dilution of samples.
• Selection of 940 nm as the primary wavelength.
The options are enabled when UDR+ F3 is selected from the Define/Edit User Defined Chemistry
screen. An Expanded UDR chemistry is denoted by a “+” placed in front of the UDR name when
viewed in the User Defined Chemistries screen.
Cal Save
Cal Save allows the calibration parameters to be retained when the cartridge is removed from the
instrument. When the cartridge is reloaded within the calibration time limit, recalibration is not
required.
Enable/Disable Cal Save
1
The instrument must be in Standby or Stopped mode.
2
Select Setup from the menu bar.
3
Select 15 User Defined Chemistries.
4
Select the number to be defined.
OR
Type a number in the Option Number field.
8-20
5
Select Define F1.
6
Select UDR+ F3.
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User Defined Reagents
Expanded User Defined Chemistry Feature
7
On page 1 of the UDR setup, select the Cal Save check box.
ORDAC
ORDAC (Over Range Detection and Correction) allows a sample to be repeated with a smaller sample
volume if the first result exceeds the defined usable result range. Just like Beckman Coulter
chemistries, ORDAC can be turned on for automatic use through System Setup, or manually
requested in the Sample Program.
Enable/Disable UDR ORDAC
1
The instrument must be in Standby or Stopped mode.
2
Select Setup from the menu bar.
3
Select 15 User Defined Chemistries.
4
Select the number to be defined.
OR
Type a number in the Option Number field.
A13914AF
5
Select Define F1.
6
Select UDR+ F3.
7
Go to page 2 of the UDR Setup, type the ORDAC sample volume, 2–40 μL. The volume entered
must be smaller than the initial sample volume.
8
Type the Lower and Upper Usable Result Range.
8-21
8
User Defined Reagents
Expanded User Defined Chemistry Feature
On Board Dilution
On Board Dilution allows all samples for the UDR to be diluted prior to analysis. An aliquot of diluent
is placed into a cuvette. Then the Sample is dispensed into the diluent and mixed. On the next cycle,
the diluted sample is aspirated from the first cuvette and dispensed into another cuvette containing
the reagent. The diluent can be either a cartridge of DIL1 (PN 467826) or Component A in the UDR
cartridge.
Enable/Disable On Board Dilution
1
The instrument must be in Standby or Stopped mode.
2
Select Setup from the menu bar.
3
Select 15 User Defined Chemistries.
4
Select the number to be defined.
OR
Type a number in the Option Number field.
5
Select Define F1.
6
Select UDR+ F3.
7
Go to page 2 of the UDR Setup, and select Dilute F2. A new window appears.
8
Type the volume of neat sample to use for the dilution, 3–40 μL.
9
Type the volume of diluent to use for the the dilution, 140–300 μL. The dilution factor
automatically calculates and shows on the screen.
10 Select either check box to define where the diluent will be aspirated from.
 UDR Component A (default)
OR
 DIL1 Cartridge
8-22
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CHAPTER 9
Maintenance
Overview
Introduction
Maintenance on the UniCel DxC System should be performed by trained personnel to insure
continued, optimal performance and to reduce unnecessary service calls. Minimum training
requires that the operator read the Maintenance procedures.
The Scheduled Maintenance Log feature allows the system to keep track of what maintenance is
needed, when it is needed, and who performed the procedure. It also provides the capabilities of
alerting the operator to the maintenance that is due, and to the maintenance procedures that have
been performed and reviewed.
Basic Laboratory Practice
The maintenance frequencies established in this manual are based on processing approximately 400
samples/day.
The number of samples processed by the system, combined with the nature of the samples, may
require the stated maintenance frequencies to be adjusted in some laboratories.
A start-up prime of the various subsystems may be necessary if the system has been idle for more
than approximately 8 hours. Refer to CHAPTER 11, Utilities for priming procedures. Reviewing
reagent status prior to running the instrument is standard laboratory practice.
As with any laboratory equipment, the exterior of the DxC system should be kept clean. Any spills
should be cleaned up promptly. Spills that may be caused by leaking reagent lines or fittings should
be investigated. Refer to As-Needed/As-Required Maintenance in this chapter for cleaning
procedures.
Certain procedures in this manual require the use of a grounded wrist strap while the procedure is
being performed. The strap portion should be placed around the wrist. The wire portion can be
connected to the system in one of the following ways:
• Alligator Clipped: Wrist straps with an "alligator" clip should be clamped onto the metal frame
of the system. To access, open either the left or center door. If desired, the doors may be closed
after the clip is attached to the metal frame.
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9-1
Maintenance
Overview
• Banana Plug Insert: Wrist straps with a "banana" plug must be inserted into the chassis ground
next to the Stop button on the front of the system (See Figure 9.1.)
Figure 9.1 Chassis Ground
IMPORTANT The system does not autoprime in Maintenance mode. After completing a maintenance
procedure, or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the
system to Standby.
Common Abbreviations
• CC – Cartridge Chemistry side of the system
• MC – Modular Chemistry side of the system
• ISE – Ion Selective Electrode (Flow Cell Module)
• EIC – Electrolyte Injection Cup
• CCWA – Cartridge Chemistry Wash Solution
• CTS – Closed Tube Sampling
Maintenance Schedule
CAUTION
If the DxC is connected to the automation line, make sure the DxC is in Manual
mode before performing any DxC maintenance procedure.
The UniCel DxC System requires maintenance to operate correctly. Maintenance is scheduled at the
following intervals:
• Twice Weekly
• Weekly
9-2
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Maintenance
Overview
• Monthly
• Two-Month
• Three-Month
• Four-Month
• Six-Month
This maintenance schedule is developed for all systems. Following specific maintenance
procedures, running calibration and controls may be required.
Twice Weekly Maintenance
• Clean Sample and Reagent Probes, Mixers, EIC, and Flow Cell
Weekly Maintenance
• Check Reagent Levels
• Replace Cuvette Wiper
• Clean Total Protein and Albumin Cups (DxC 800 only)
• Clean Probes (Exterior)
• Clean Flow Cell, Cups and CC Probes/Mixers (Automated) (This weekly maintenance is
superceded by the mandatory Twice Weekly procedure Clean Sample and Reagent Probes,
Mixers, EIC, and Flow Cell.)
• Check Chloride Calibration Span
Monthly Maintenance
• Replace Alkaline Buffer
• Clean All Cup Modules
• Clean Mixers
• Calibrate Lamps and Sensor
• BUNm/UREAm Electrode Maintenance
• Replace CTS Blade (1-Blade Narrow CTS Option)
Two-Month Maintenance
• Replace CTS Blade/Wick (1-Blade Thick CTS option)
• Change/Clean Air Filters
Three-Month Maintenance
• Replace Syringe Plungers
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9-3
9
Maintenance
Electronic Maintenance Log
Four-Month Maintenance
• Clean MC Reagent Lines
Six-Month Maintenance
• Replace CALC Electrode Tip (6 months or 80,000 samples)
• Replace K Electrode Tip
• Replace Glucose Sensor
Electronic Maintenance Log
Feature Summary
Maintenance items are grouped together by frequency of performance. Only the maintenance items
appropriate for the particular system and installed hardware are shown. For example, a system that
does not have Closed Tube Sampling (CTS) hardware does not show the maintenance items for that
hardware. On the Scheduled Maintenance Log screen these groups have been placed under separate
tabs labeled:
• Weekly
• Monthly
• Two-Month
• Three-Month
• Four-Month
• Six-Month
To identify the maintenance procedures that are DUE, follow the yellow highlights as listed below:
• Select Utils from the menu bar,
• Select 2 Maintenance,
• Select Log F2,
• Select the appropriate highlighted maintenance tab.
The yellow highlights appear according to the following schedule:
• Weekly - 8 days
• Monthly - 31 days
• Two-Month - 61 days
• Three-Month - 91 days
• Four-Month - 121 days
• Six-Month - 181 days
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Maintenance
Electronic Maintenance Log
Maintenance information is not lost during normal software version updates. The maintenance
counter is reset to zero if a complete install of the software is performed under unusual
troubleshooting or system repair situations.
IMPORTANT Back up maintenance files onto a diskette at scheduled intervals. Refer to CHAPTER 11, Utilities
for Backup/Restore instructions. You can also print and store Electronic Maintenance data if required by
laboratory policy.
Access the Scheduled Log Feature
1
Select:
• Utils from the menu bar,
2
•
2 Maintenance,
•
Log F2.
Select the tab that represents the desired maintenance items.
Screen Description
Use the touch screen or the mouse to access each of the tabs shown and all of the functions available
under each tab. Enter data into any data field by selecting the field as described above and typing
the information using the keyboard. Press (Enter) to save the data.
The tabs and available functions of the Scheduled Maintenance Log feature are described below.
Help
On-line Help is available through the Scheduled Maintenance Log feature and Automated
Maintenance Procedures. Select the Help icon
next to the maintenance procedure to display
specific information about the procedure. If the Help icon is grayed out, this indicates the
Instructions For Use manual is not loaded.
Procedure
This area lists all of the procedures required at the specified frequency. Each of the maintenance
procedures has a number associated with it. These numbers indicate any action that might be
necessary after a maintenance procedure has been completed. The definitions for each number are:
• 0 = No action required.
• 1 = Run Controls. If controls are within specifications, no more action is necessary. If controls
are out of specification calibration or routine troubleshooting may be necessary (usually
verifying that there are no leaks or loose components due to maintenance resolves the issue.)
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9
Maintenance
Electronic Maintenance Log
• 2 = Calibrate the affected assays and run controls. If controls are out of specification, calibration
or routine troubleshooting may be necessary (usually verifying that there are no leaks or loose
components due to maintenance resolves the issue.)
An abbreviated version of these definitions can be found at the bottom of each Scheduled
Maintenance Log screen.
Select All
This function allows the operator to select all the maintenance procedures available on the screen
for initial and date entry all at one time. Refer to Initial and Date Check Box/Initial and Date Button
in this chapter.
Initial and Date Check Box/Initial and Date Button
This function allows the operator to select the procedure and enter the initials of the person who
performed the procedure and the date it was performed. When a maintenance procedure is
completed, select the Initial and Date checkbox. To complete the entry of this information, select the
Initial and Date button.
When a procedure has had initials and date entered, the maintenance counter resets for the
appropriate time interval.
Sensor/Electrode Number
When you complete the Initial and Date button entries for six month maintenance, you must enter
a sensor/electrode number. Record the number found on the sensor or electrode before you install
it.
Date Performed Field
Shows the date entered by the operator on which the maintenance was performed.
Initials Field
Shows the initials entered by the operator of the person who performed the maintenance.
Days Left Field
Shows the number of days left until a maintenance procedure is due. The word DUE is shown in this
area highlighted in yellow when a procedure is actually due or past due to be performed.
A yellow DUE indication will NOT prevent the system from being run.
IMPORTANT If a maintenance procedure was never entered into the system by inputting initials and date,
only the DUE field is yellow. The pathway is not activated. This gives the operator the option to not use
the Scheduled Maintenance Log feature. There is no way to deactivate the yellow DUE highlighting at the
Scheduled Maintenance Log screen level.
Counts Left Field
Certain maintenance procedures are better tracked by counting the number of samples run through
the system. This column shows a countdown of the number of samples that can be run until the
maintenance procedure is due to be performed. If no numbers appear in this column the procedure
is tracked by time not count.
History
The History icon
provides a stored history of maintenance performance with dates and initials
for the procedure selected.
9-6
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Maintenance
Twice Weekly Maintenance
Delete
The operator can use this option to delete old maintenance information from stored history.
NOTE Beckman Coulter recommends that you print out any maintenance history before you delete it. Once
deleted, there is no way to recover the information.
Print
When a time period (Month and Year) is entered, this button prints all of the maintenance tabs and
associated maintenance data.
Approve
This option allows a separate review and approval by allowing the reviewer to enter their initials
and the review date into the fields shown.
Maintenance Action Legend
This area gives a brief description of the actions that should be taken when a maintenance
procedure is completed.
Done
This option exits the Scheduled Maintenance Log feature and returns the operator to the
Maintenance screen.
Twice Weekly Maintenance
Introduction
Perform Twice Weekly Maintenance on the same days each week. These procedures prevent
contamination build-up on the instrument.
Clean Sample and Reagent Probes, Mixers, EIC, and Flow Cell
Clean the MC Sample Probe, CC Sample Probe, Reagent Probes and Mixers, EIC and Flow Cell twice
weekly to prevent sample, reagent, or system and hardware errors. You can reduce erratic
chemistry results such as drift and noise, or chemistry performance problems such as imprecision
when you keep a regular cleaning schedule.
Materials Required
• Diluted Clenz Solution (PN 664090) freshly prepared. Add four drops of Clenz Solution to an
empty 2 mL cup, fill to the 2 mL line with saline and mix.
• 0.9% Saline (Buffered Blood Bank Saline Can Not be Used)
• CCWA cartridge PN 657133 (Wash Solution)
• Sample racks
• 2mL sample cups
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9
Maintenance
Twice Weekly Maintenance
• Sodium Hypochlorite 5.25% (PN A32319). (DO NOT substitute “household” bleach products that
may contain thickeners or sodium hydroxide.)
NOTE. If the electrolyte calibration has reached time-out, you MUST extend the calibration to continue
with this cleaning procedure.
1
To load the CCWA cartridge on the system:
• Select Rgts/Cal from the menu bar
• Select an empty chem position to load (CC side)
• Select Load [F1].
• Load Cartridge Chemistry Wash Solution (CCWA).
2
Select Samples from the menu bar.
NOTE. Disable Serum Index to continue with this cleaning procedure.
3
In the Program Sample screen:
• Enter a rack number and press Enter
• Enter a position number and press Enter
• Enter a Sample ID (optional).
9-8
4
Select any one of the ISE chemistries (for example, K for diluted Clenz Solution, Sodium
Hypochlorite and Saline).
5
Select Options [F3].
6
Enter the required number of replicates in the Reps field and select (OK) . Refer to table in
step 7.
7
Press Next [F10] to program the remaining positions. Repeat steps 3 thru 7 for each sample
position.
Rack
Sample
Position
Chem
Reps
Fluid
XXX
1
K
15
Diluted Clenz Solution
2
K
CCWA
5
10
Saline
Saline
3
K
15
Sodium Hypochlorite
4
K
5
Saline
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Maintenance
Weekly Maintenance
8
Fill the 2 mL sample cups with diluted Clenz Solution, Sodium Hypochlorite and Saline and
place into the correct rack and positions identified in step 7.
9
Load the sample rack on the system, and press the RUN button on the instrument.
NOTE. Ignore the results for these samples.
10
Calibrate the electrolytes and run controls.
11
Remove the CCWA wash solution cartridge.
• Replace the cap on the cartridge and store at room temperature to use at the next
maintenance interval.
• Discard the cartridge after four months.
12 Record the maintenance procedure in the Action Log.
• Select Utils from the menu bar
• Select 2. Maintenance.
• Select Action [F1].
• Record the Twice Weekly maintenance and press Save.
13 To remove the yellow highlight from the maintenance icon, select the Initial and Date checkbox
for both the Clean Flow Cell and Cups and the CC Probe Cleaning procedures under the weekly
maintenance tab in the electronic maintenance log. To complete the entry of this information,
select the Initial and Date button. When a procedure has had initials and date entered, the
maintenance counter resets for the appropriate time interval.
NOTE. Entering of initials and date for the Clean Flow Cell and Cups and CC Probe Cleaning will have to
be done on a weekly basis to ensure that the yellow highlight does not remain lit for the tasks which
are being replaced by the Twice Weekly procedure.
Weekly Maintenance
Check Reagent Levels
Clean Total Protein and Albumin Cup Modules (DxC 800 Only)
Clean Probes (Exterior)
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Maintenance
Weekly Maintenance
Clean Flow Cell, Cups and CC Probes/Mixers (Automated) This weekly maintenance is superceded
by the mandatory Twice Weekly procedure Clean Sample and Reagent Probes, Mixers, EIC, and Flow
Cell.
Check Chloride Calibration Span
Check Reagent Levels
Check the levels of these MC reagents: Wash Concentrate II, No Foam and CTS Auto-Gloss (CTS
option only). To check the levels, perform the following procedure:
1
Select Rgts/Cal from the menu bar.
2
Select the Down Arrow to review the second page screen.
3
To access the modular reagents, open the left and middle doors.
NOTE The CTS Auto-Gloss bottle is in a bracket on the inside of the middle door.
4
Examine the reagent levels in the bottles and compare them with the percentages on the screen
(Wash, No Foam and Auto-Gloss).
5
If the volume shown does not match the actual reagent volume, enter the correct volume for
each reagent in the Vol field.
NOTE A pop-up message appears when approximately 10% and 5% of an MC reagent remains.
6
If necessary, load a new bottle of reagent.
Be careful when handling the bottle of CTS Auto-Gloss or No Foam. Prevent spills. These
solutions are extremely slippery and difficult to clean from the floor.
Refer to CHAPTER 4, Reagent Load/Calibration, Reagent Load in this manual.
7
Close the left and middle doors.
Replace Cuvette Wiper
With constant use, the cuvette wiper can deteriorate and become stained and torn. The cuvette
wiper should be changed weekly or as needed to maintain the cleanliness and integrity of the
cuvette.
9-10
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Maintenance
Weekly Maintenance
1
Remove the cuvette wash station cover. Pull up on the two locking pins (1). Pivot the right side
of the cover, turning it forward. Lift out the cover, being careful not to disturb the CC sample
mixer.
Figure 9.2 Cuvette Wash Station Cover
2
Loosen the two thumbscrews (1) on each side of the cuvette washer. Lift off the upper section
of the cuvette wash assembly. Pull off the silicone wiper.
Figure 9.3
3
A13914AF
Install new wiper (1) by sliding it onto the bottom of the probe until the under surface of the
wiper is flush with the end of the probe.
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9
Maintenance
Weekly Maintenance
Figure 9.4
NOTE The wiper tip should be square to the cuvette. The under surface of the wiper should be flush with
the end of the washer probe.
4
Replace the upper section of the cuvette wash assembly and tighten the thumbscrews fingertight. Make sure the wash assembly is seated properly on the mounting pins.
5
Verify that all four wash tower probes are centered over a cuvette. Failure to do so may cause a
flood.
6
Reinstall the cuvette wash station cover.
Clean Total Protein and Albumin Cup Modules (DxC 800 Only)
Total Protein and Albumin modular reaction cups and stir bars should be cleaned weekly, or more
frequently if the chemistry does not calibrate, or when chemistry performance indicates.
IMPORTANT For convenience, the Total Protein and Albumin Cup Maintenance procedure is also included
with the other modular chemistries in Monthly maintenance. Weekly Total Protein and Albumin Cup
Maintenance should be performed at equally distanced intervals.
IMPORTANT The system must be in Standby in order to access the Maintenance mode.
9-12
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Maintenance
Weekly Maintenance
Cleaning Preparation
Prepare the following solutions before beginning the cleaning procedure:
1N HCL solution
Combine one part 6N HCL and five parts of deionized water for cleaning Total
Protein cup.
AND
10% Cleaning Solution
Combine one part Wash Concentrate II with nine parts of deionized water for
cleaning Albumin cup.
Cleaning Procedure
1
Select:
• Utils from the menu bar,
•
2 Maintenance,
•
4 Cup Maintenance,
• Total Protein and Albumin.
2
Select Rinse.
The cups are drained and rinsed 5 times with water. A Result pop-up window appears when the
Rinse procedure is complete. DO NOT close the window at this time.
3
When the pop-up window appears, use a transfer pipette to manually add:
• One mL of 1N HCL solution to the Total Protein cup.
• One mL of 10% Cleaning solution to the Albumin cup.
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4
Let the cleaning solution sit in the cups for 10 minutes. The stir bars continues to stir during
this time.
5
At the end of the 10 minute waiting period, select Close to exit the Result pop-up window.
6
Select Rinse. The cups are drained and rinsed 5 times with water.
7
When the Rinse procedure is complete, select Close to exit the Result pop-up window, then
select Drain.
8
When the Drain procedure is complete, select OK to continue. When activity has completed
select Close to exit the Result pop-up window, and select Cancel to return to the Maintenance
menu.
9-13
9
Maintenance
Weekly Maintenance
9
Calibrate Total Protein and Albumin chemistries and run QC materials.
IMPORTANT A lamp calibration should be performed after Total Protein and Albumin cup maintenance
on a MONTHLY basis. You are not required to perform the ALBm and TPm lamp calibration following
the Weekly maintenance.
Clean Probes (Exterior)
Follow the steps below to clean the exterior of the sample and reagent probes. Periodic wiping of
the probes is needed to clean the entire (upper and lower) probe area.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Press the STOP button on the instrument to place the system into Stopped state.
The probes are ready for manual maintenance when system status is Stopped.
2
Wipe the outside and bottom of any exposed portions of the sample and reagent probes, and all
of the cuvette wash station probes. Use a lintless tissue moistened with 70% isopropyl alcohol
or a 70% isopropyl alcohol pad.
NOTE Use a separate pad for each probe.
Do not pull or exert pressure on probes, which can cause bending.
9-14
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Maintenance
Weekly Maintenance
3
To access the lower portions of the CC reagent probes (under the attached wash collars) remove
the reaction carousel cover, then:
• Move the reagent probes from the home position to the maintenance indentation (1).
• Press the probe down into the depression.
• Wipe the outside portion of the exposed probe.
Figure 9.5
1
A015937P.EPS
4
To access the lower portions of the MC and CC sample probes (under the attached wash collars)
remove the sample carousel cover. To continue access:
• Move the sample probes to a clear space (1), between the sample carousel racks and the
sample carousel tub.
• Press the probe down into the clear area.
• Wipe the outside portion of the probe.
Figure 9.6
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9
Maintenance
Weekly Maintenance
5
When all maintenance steps are complete, reinstall covers and select:
• OK to clear the pop-up message,
•
Instr Cmd from the menu bar,
•
1 Home.
Clean Flow Cell, Cups and CC Probes/Mixers (Automated)
This weekly maintenance is superceded by the mandatory Twice Weekly procedure Clean Sample
and Reagent Probes, Mixers, EIC, and Flow Cell.
To clean the flow cell, MC Sample Probe, selected cup modules, CC Sample Probe, reagent probes and
mixers follow the procedure below.
Materials Required:
• Diluted Clenz Solution freshly prepared by adding 4 drops of Clenz Solution
(PN 664090) to an empty 2 mL sample cup. Fill to 2 mL line with 0.9% saline and mix.
• 2 mL sample cup of 0.9% saline, required for CC Probes/Mixers.
• CCWA cartridge (PN 657133), required for CC Probes/Mixers. CCWA must have at least 25 tests
available.
Cleaning Procedure
1
Load CCWA cartridge.
2
Select Utils from the menu bar.
3
Select 2 Maintenance.
4
Select 10 Clean Flow Cell, Cups and CC Probes/Mixers.
5
Follow the instructions on the screen.
NOTE All components are selected by default. All components except the flow cell can be deselected if
you don’t want to clean them.
9-16
6
Select Close to exit the Result window after cleaning is completed.
7
Select Close to exit the procedure.
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Maintenance
Check Chloride Calibration Span
Check Chloride Calibration Span
The system automatically monitors the CL span with each calibration. If the span falls below 1800,
the system highlights the Check Chloride Calibration Span task in the Weekly tab of the Electronic
Maintenance Log. When the task is highlighted, replace the chloride electrode tip as soon as
convenient. See Replace the Chloride Electrode.
To check the chloride calibration span manually:
1
During the daily calibration routine, the AQUA CAL 2 Calibration Report is automatically
printed. If necessary, reprint this report. See Reprint Calibration Reports.
2
Refer to page 2 of the calibration report. Check the CL span value at the bottom of the page. If
the value is <1800, replace the electrode tip when it is convenient to your work load. See Replace
the Chloride Electrode.
Monthly Maintenance
Replace Alkaline Buffer
Adjust the Fluid Level of the Alkaline Buffer Damper Assembly
Clean All Cup Modules
BUNm/UREAm Electrode Maintenance (DxC 800 Only)
Calibrate Lamps and Sensor
Clean Mixers
Replace CTS Blade (1-Blade Narrow CTS Option)
Replace Alkaline Buffer
The following procedure describes how to replace the Alkaline Buffer reagent and the In-line air
filters.
A13914AF
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin (1) on the ISE module and lift the module until it clicks into a raised,
locked position. The locking pin is located on the left side of the ISE module on DxC 800 Systems
as shown in Figure 9.7. The locking pin is located on the right side of the ISE module on DxC 600
Systems.
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9
Maintenance
Monthly Maintenance
Figure 9.7 DxC 800 ISE Module
3
Unscrew and remove the bottle cap from the alkaline buffer reagent. Hold the cap with attached
straw over a container that catchs the residual fluid from the alkaline buffer return line #33.
4
Prime the line 10 times.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE CO2 Alkaline Buffer.
• Type 10 in the Number of primes to repeat field.
• Select Start Prime. Reagent line is drained of old reagent.
5
9-18
Remove reagent input line #30 (1) (line draining into damper) from the top of the in-line filter.
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Maintenance
Monthly Maintenance
Figure 9.8
6
Twist off the in-line filter (PN 669212) from the input line and replace.
NOTE When installing in-line filters, be sure the arrow on the filter is pointing in the direction of reagent
flow.
7
After installation of the filter is complete, reattach reagent input line #30 (that flows into
damper) to the top of the filter.
8
Select:
• Rgts/Cal from the menu bar,
• MC Rgts,
•
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Load F1.
9-19
9
Maintenance
Monthly Maintenance
9
Place a fresh bottle of alkaline buffer on the system. Wipe reagent straw and replace bottle cap
onto the new reagent bottle.
Figure 9.9
10 Load reagent information from bottle bar code into the system either automatically using the
hand-held bar code reader, or manually using the keyboard. Refer to CHAPTER 4, Reagent Load/
Calibration in this manual.
11 Select Done F10 when finished.
12 While priming with the alkaline buffer reagent, check the peri-pump tubing and line for leaks
or other problems. Correct as needed.
13 Adjust the fluid level of the Alkaline Buffer Damper Assembly. Refer to the Adjust the Fluid Level
of the Alkaline Buffer Damper Assembly procedure.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
14 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
15 Reinstall the ISE module cover.
9-20
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Maintenance
Monthly Maintenance
16 Calibrate the CO2 chemistry.
Adjust the Fluid Level of the Alkaline Buffer Damper Assembly
1
Visually inspect the damper to verify that the fluid level rests between the MIN and MAX lines,
approximately one-third to one-half full.
If the fluid level is below the MIN line, proceed to Step 2.
If fluid level is above the MAX line, go to Step 8.
2
Remove the alkaline damper (1) from the holding clip and place the damper in a horizontal
position.
Figure 9.10
1
2
A015938P.EPS
NOTE The damper should be positioned so that the output line #29 (2) Figure 9.10, leading from the
damper to the flow cell, is oriented on top.
3
Prime alkaline buffer five times or as many times as necessary to fill the damper one-half full.
Access alkaline buffer priming.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE CO2 Alkaline Buffer.
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Maintenance
Monthly Maintenance
• Type 5 in the Number of primes to repeat field.
• Select Start Prime. (Prime cycles are completed when Standby appears in the system status.)
4
Observe the fluid level during prime cycles. As the damper becomes half full, turn the damper
to the upright position.
5
Wipe dry any reagent spill on the damper assembly.
6
Clip the damper assembly back into the upright position.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
7
Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
8
Reinstall the ISE module cover.
9
If the fluid level is above the MAX line:
Remove input line #30 (1) feeding into the damper.
• Using a clean transfer pipette, remove excess reagent until damper is one-half full. Discard
the removed fluid.
• Reconnect input line #30 to the damper, wipe dry any reagent spill on the damper top.
Figure 9.11
9-22
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Maintenance
Monthly Maintenance
10 Prime the alkaline buffer three times.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE CO2 Alkaline Buffer.
• Type 3 in the Number of primes to repeat field.
• Select Start Prime. (Prime cycles are completed when Standby appears in the system status.)
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
11 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
12 Reinstall the ISE module cover.
Clean All Cup Modules
Albumin, Urea Nitrogen, Glucose, Phosphorus, Creatinine, and Total Protein cup modules need to
be cleaned monthly. Prepare the cup modules for cleaning as follows:
Table 9.1 Cup Cleaning Preparation
MC Module
Prepare
By Diluting
ALBma, BUNm/UREAma,
GLUCma,b, PHOSma
10% cleaning solution
One part Wash Concentrate II with
nine parts deionized water.
CREma, TPma
1N HCL
One part 6N HCL with five parts
deionized water.
a. ALBm, BUNm/UREAm, GLUCm, PHOSm, CREm and TPm cup modules are on DxC 800 Systems.
b. Only the GLUCm cup module is on DxC 600 Systems.
The following procedure can be applied to all modular chemistry cups. Where applicable, the
procedure lists instructions specific for a particular cup. It is important to follow any special case
instructions. It is recommended to prepare all requested cups for maintenance at the same time.
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9
Maintenance
Monthly Maintenance
Cup Cleaning Procedure
1
Select:
• Utils from the menu bar,
•
2 Maintenance,
•
4 Cup Maintenance,
• Appropriate chemistries.
2
Select Rinse. The cups are drained and rinsed 5 times with water.
IMPORTANT To prevent damage to either the BUNm/UREAm electrode or GLUCm* sensor, do not insert
transfer pipette or any other object down into the bottom of the cup. It is not required to remove the stir
bars from any cup during this cleaning procedure.
3
When rinsing is complete, use a transfer pipette to manually add:
• One mL of 10% cleaning solution to each of the cups, BUNm/UREAm, GLUCm* PHOSm, and
ALBm.
• One mL of 1N HCL solution to each of the cups, TPm, and CREm.
4
Let the cleaning solutions sit in the cups for 10 minutes. The stir bars continues to stir during
this time.
5
At the end of the 10 minute waiting period, select Close to exit the Result pop-up window.
6
Select Rinse. The cups are drained and rinsed 5 times with water.
7
When rinsing is complete, select Close to exit the Result pop-up window.
8
Highlight all chemistries and select Drain.
9
When draining is complete:
• Select OK in the Maintenance pop-up confirmation window.
• Select Close when priming is complete to exit the Result pop-up window.
• Select Cancel to return to the Maintenance screen.
* Only the GLUCm cup module is on DxC 600 Systems.
9-24
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Maintenance
Monthly Maintenance
BUNm/UREAm Electrode Maintenance (DxC 800 Only)
1
Drain the reagent from the MC cups.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 4 Cup Maintenance.
2
Select BUNm/UREAm to be drained in preparation for maintenance if performing BUNm/
UREAm maintenance.
Select Drain. A pop-up confirmation window indicates that the cup is drained and ready for
maintenance.
3
Loosen the two Phillips screws on the ISE module cover and remove the cover.
4
Loosen the two screws (1) on the MC cover and gently remove the cover.
Figure 9.12
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9-25
9
Maintenance
Monthly Maintenance
5
Press the latch, which is located on the connector (1), to disengage the electrode pin lead from
the connector panel and remove the electrode connector from the socket.
Figure 9.13
6
Unscrew the BUNm/UREAm electrode retainer nut (1) and withdraw the electrode-retainer
assembly from the chemistry reaction cup.
Figure 9.14
7
Separate the electrode (3), retainer (2) and retainer nut (1). Refer to Figure 9.15.
It is not required to clean the stir bar, however, the stir bar may be cleaned if desired while the
BUNm electrode is removed from the cup. Refer to Four Month Maintenance, Clean the MC
Reagent Lines, section in this chapter.
9-26
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Maintenance
Monthly Maintenance
CAUTION
Do not scratch gold coating on the face of the electrode as excessive scratches
may adversely affect performance.
8
Remove the quad-ring (4) from the front face of the electrode. Refer to Figure 9.15.
Figure 9.15
1. Retainer Nut
2. Retainer
9
3. Electrode
4. Quad-Ring
Rinse the quad-ring in deionized water. Dry with a lintless tissue.
10 Use a lintless tissue moistened with deionized water to clean the electrode face until the gold
surface is bright. Rub parallel to the gap (1) with tissue. Rinse with deionized water. Dry with a
lintless tissue.
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9
Maintenance
Monthly Maintenance
Figure 9.16
11 Apply a thin coating of Silicone Compound (PN 879049) over the tip of the electrode. Carefully
wipe the electrode end parallel to the gap with lintless tissue to remove all evidence of
compound. Rub to a bright finish.
IMPORTANT Thoroughly wipe off the electrode surface to remove any residual silicone compound.
Excess compound could prevent a successful calibration.
12 Using lintless tissue saturated with deionized water; clean the electrode mounting port.
13 Using dry, lintless tissue, wipe the electrode mounting port.
14 Reinstall the quad-ring on the face of the electrode.
15 Reinstall the retainer and retainer nut on the BUNm/UREAm electrode.
16 Rotate the electrode until the electrode key enters the retainer keyway and reinstall the
retainer nut on the electrode-retainer assembly.
17 Align the keyway on the body of the retainer containing the electrode with the key in the
electrode port and install electrode assembly. Finger-tighten retainer nut.
18 Reconnect the pin lead into the connector panel by aligning the latch on the connector with the
notch on connector panel. Push the pin lead into the connector panel until the latch clicks.
Refer to Figure 9.13.
9-28
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Maintenance
Monthly Maintenance
19 Select OK in the Maintenance pop-up confirmation window. The BUNm/UREAm cup is primed
with water.
20 Select Close when priming has completed to exit the Result pop-up window.
21 Select Prime5, to prime BUNm/UREAm 5 times with reagent. While the module is priming:
• Observe the reagent line and reaction cup to confirm there are no leaks.
— If any leaks are noticed correct the problem.
• Observe the stir bar to verify that it is rotating properly.
— Select Close when priming is complete.
22 Select Drain. When draining is complete, select OK.
23 When priming is complete, select Close to exit the Result pop-up window and select Cancel to
return to the Maintenance menu.
• If the BUNm/UREAm electrode maintenance was performed, wait 15–20 minutes to allow
for thermal equilibration. Calibrate BUNm/UREAm.
• To ensure there are no bubbles in the BUNm/UREAm cup, immediately prior to calibrating,
wrap the tip of an applicator stick with lintless tissue. Insert the end of the stick into the
bottom of the cup and carefully swab the electrode.
24 Proceed to Calibrate Lamps and Sensor.
Calibrate Lamps and Sensor
Calibrate lamps and/or sensor following monthly cup maintenance, sensor replacement, or any
adjustment made to the module.
IMPORTANT The system does not autoprime in Maintenance mode. After completing the maintenance
procedure, or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the
system to Standby.
1
Select Utils from the menu bar.
2
Select 2 Maintenance.
OR
Type 2 in the Option Number field and press (Enter) .
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9
Maintenance
Monthly Maintenance
3
Select 8 CUPs Lamp/Sensor Calibration.
OR
Type 8 in the Procedure No. field and press (Enter) .
IMPORTANT Always calibrate a chemistry following a CUPs Lamp/Sensor Calibration.
4
To calibrate Albumin, Creatinine, Phosphorus, and Total Protein (DxC 800 only):
• Select the following Lamp Calibration check boxes:
 ALBm
 TPm
 CREm
 PHOSm
5
To calibrate the Glucose Sensor:
• Select the GLUCm* check box:
 GLUCm
6
Select Start. The calibration process begins and continues for 5–7 minutes and ends with a pass/
fail indication.
• If lamp or sensor calibration fails, repeat calibration and check to see that cups fill with
water.
• If the cup is full and the calibration fails, the lamp or sensor may need to be replaced. Refer
to Six-Month Maintenance procedures in this chapter for glucose sensor replacement.
7
Select Close to exit the Lamp/Sensor Calibration screen.
8
Proceed to Reassemble the MC Components.
IMPORTANT Always calibrate a chemistry following a CUPs Lamp/Sensor Calibration.
Reassemble the MC Components
After all maintenance procedures are complete on the MC (all electrodes have been serviced), follow
the steps below to reassemble the MC components.
* Only the GLUCm cup module is on DxC 600 Systems.
9-30
A13914AF
Maintenance
Monthly Maintenance
1
Carefully replace MC cover over reaction cup modules and tighten screws.
IMPORTANT While the ISE cover is removed, for maximum efficiency, the Adjust the Fluid Level of the
Alkaline Buffer Damper Assembly procedure (in this chapter) can be performed.
2
Reinstall the ISE module cover.
3
Calibrate all applicable cup chemistries.
Clean Mixers
Wipe the mixers monthly to clean any buildup or discoloration that may accumulate over time.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
Gently but thoroughly wipe the outside of both mixers (1) and (2) of Figure 9.17 using 70% isopropyl
alcohol and lintless tissue or with a 70% isopropyl alcohol swab. Inspect mixers for scratches or
nicks and replace if necessary.
Figure 9.17 CC Sample and Reagent Mixers
1
2
A015939P.EPS
1. CC Sample Mixer
2. CC Reagent Mixer
A13914AF
9-31
9
Maintenance
Monthly Maintenance
Replace CTS Blade (1-Blade Narrow CTS Option)
Refer to Figure 9.18. Replace the Cap Piercer blade approximately once a month. If the system runs
>500 samples per day, replace the blade more frequently. The blade count records the number of
caps pierced by the blade. Refer to CHAPTER 10, System Status and Commands.
CAUTION
The Cap Piercer blade is very sharp and has been exposed to potentially
biohazardous fluids. To prevent injury or exposure, do not touch the points of the
blade and wear gloves.
Figure 9.18 Cap Piercer Blade
A014848P.EPS
Materials Required:
• Medium straight-edge screwdriver
Replacement Procedure
1
To access this procedure,
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 1 CTS Blade Replacement.
• To start the procedure select Continue.
OR
• To exit this screen select Cancel.
2
9-32
The instrument prepares for blade replacement, then the Maintenance pop-up confirmation
window appears.
A13914AF
Maintenance
Monthly Maintenance
CAUTION
The points of the Blade are very sharp and extend below the Wash Tower. Avoid
the bottom of the Wash Tower.
CAUTION
DO NOT select OK when the cover is removed. If you select OK the Cap Piercer
Carriage moves up and causes a pinch hazard.
3
Fully loosen the two captive Cap Piercer cover screws (1) at the base of the Cap Piercer cover.
Lift and remove the cover.
Figure 9.19
1
A014462P.EPS
A13914AF
9-33
9
Maintenance
Monthly Maintenance
4
Refer to Figure 9.20.
• Fully loosen the one captive blade screw (2).
• Fully loosen the two captive blade holder screws (1).
• Remove the blade holder.
Figure 9.20
1
2
A014850P.EPS
5
Hold the blade at the top of its shaft. Do NOT touch the points of the blade.
6
Lift up the blade to remove it.
7
Discard the old blade into a biohazard sharps container.
NOTE The points of the blade are very sharp.
8
Remove a new blade from its container.
9
Hold the blade holder with the blade hole on the top. Note that the blade hole is keyed and the
blade has a slot.
Install the blade into the blade holder as follows:
• Rotate the blade, if necessary, until it falls into place.
• Finger tighten the captive blade screw.
• Remove the protection from the points of the blade.
• Do NOT touch the points of the blade.
9-34
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Maintenance
Monthly Maintenance
10 Carefully move the points of the blade down through the wash tower and through the
alignment slot at the bottom:
• Push down on the blade holder screws and align them over their holes.
• Slowly lower the blade until the blade holder screws are in their holes. Do NOT hit the
points of the blade against the opening as you lower the blade.
• Install and tighten the two captive blade holder screws. Tighten the captive blade screw.
11 Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws.
12 Select OK.
• The system sets the blade count to zero.
• The Cap Piercer carriage moves up to Home position.
13 Simulate the load of CTS Auto-Gloss Lubricant by clearing and resetting the values on the
Auto-Gloss screen at Reagent Load.
• Select MC Reagent Load from the screen,
• Select Auto Gloss,
• Select F1, Clear.
• Type XXXXX in the Lot field. (Refer to Note below)
• Type NA in the SN field.
• Type Current month, 1 year greater than the current year in the Date field.
NOTE Use 00001 as the first lot number. For each additional load, use one number greater than the
number displayed in the lot number field.
A13914AF
9-35
9
Maintenance
Two-Month Maintenance
Two-Month Maintenance
Replace CTS Blade/Wick (1-Blade Thick CTS Option)
Change/Clean Air Filters
Replace CTS Blade/Wick (1-Blade Thick CTS Option)
Refer to Figure 9.21. Replace the Cap Piercer blade and its CTS Auto-Gloss wick approximately every
two months. If the system runs >500 samples per day, replace the blade and wick more frequently.
The blade count records the number of caps pierced by the blade. Refer to CHAPTER 10, System
Status and Commands.
CAUTION
The Cap Piercer blade is very sharp and has been exposed to potentially
biohazardous fluids. To prevent injury or exposure, do not touch the points of the
blade and wear gloves.
Figure 9.21 Cap Piercer Blade with CTS Auto-Gloss Wick
1
2
4
5
3
A007367P.EPS
1. Blade Clamp
2. Blade
3. Points
4. Wick Clip
5. Wick (in clip housing)
Materials Required:
• Medium Phillips screwdriver
• Small Phillips screwdriver
• Medium straight-edge screwdriver
9-36
A13914AF
Maintenance
Two-Month Maintenance
Replacement Procedure
1
To access this procedure, select:
• Utils from the menu bar
•
2 Maintenance
• 1 CTS Blade Replacement.
To start the procedure, select Continue.
OR
To exit this screen, select Cancel.
2
The instrument prepares for blade and wick replacement, then the Maintenance pop-up
confirmation window appears.
CAUTION
The points of the Blade are very sharp and extend below the Wash Tower. Avoid
the bottom of the Wash Tower.
CAUTION
DO NOT select OK when the cover is removed. If you select OK the Cap Piercer
Carriage moves up and causes a pinch hazard.
3
Fully loosen the two captive Cap Piercer cover screws (1) at the base of the Cap Piercer cover.
Lift and remove the cover.
Figure 9.22
1
A014462P.EPS
A13914AF
9-37
9
Maintenance
Two-Month Maintenance
4
Refer to Figure 9.23.
• Fully loosen the one captive blade screw (2).
• Push down on this screw until the blade (3) separates from the blade holder (4).
• Fully loosen the two captive blade holder screws (1).
• Remove the blade holder (4)
• Unclip the wick clip (5).
Figure 9.23
2
1
4
3
5
A015940P.EPS
9-38
A13914AF
Maintenance
Two-Month Maintenance
5
Refer to Figure 9.24.
Remove the blade and wick assemblies as follows:
• Hold the blade (1) at the top. Do not touch the points (2) of the blade.
• Lift up the blade and remove it with the wick assembly at the same time:
— The wick assembly (3) should be attached to the blade.
— Do not touch the wick because it contains CTS Auto-Gloss lubricant which is very
slippery and difficult to clean.
• Discard the old assemblies into a biohazard sharps container.
Figure 9.24
1
3
2
6
A011872P.EPS
Refer to Figure 9.24.
NOTE A new blade is shipped with a wick attached. The points of the blade are very sharp. The blade
shaft is not sharp.
• Remove a new blade and wick from its container.
• Hold it at the top of the blade (1), immediately under the blade clamp as shown in
Figure 9.24.
A13914AF
9-39
9
Maintenance
Two-Month Maintenance
7
Refer to Figure 9.25.
Hold the blade holder (5) with the blade clamp hole (3) on the top as shown. Note that the blade
clamp hole (3) is keyed and the blade clamp (2) has a slot. Install the blade (1) into the blade
holder (5) as follows:
• Put the blade clamp end (2) of the blade into the blade clamp hole (3).
• Rotate the blade, if necessary, until it falls into place.
• Finger tighten the captive blade screw (4).
• Remove the protection from the points (6) of the blade.
• Do not touch the points of the blade.
Figure 9.25
6
1
2
3
5
4
A015941P.EPS
8
Refer to Figure 9.23.
Carefully move the points of the blade down through the wash tower and through the
alignment slot at the bottom:
• Push down on the blade holder screws (1) and align them over their holes.
• Slowly lower the blade through the alignment slot until the blade holder screws are in their
holes. Be careful not to hit the points of the blade on the edge of the metal alignment slot.
• The blade is through the alignment slot when the blade holder touches the surface of the
frame of the cap piercer.
• Secure wick clip to blade holder wash block.
• Install and tighten the two captive blade holder screws (1). Tighten the captive blade screw
(2).
9-40
A13914AF
Maintenance
Two-Month Maintenance
9
Refer to Figure 9.22.
Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws (1).
10 Select OK.
• The system sets the blade count to zero.
• The Cap Piercer carriage moves up to Home position.
• The system primes the wick with CTS Auto-Gloss lubricant.
Change/Clean Air Filters
IMPORTANT To minimize system down time, it is recommended to keep on hand a clean set of air filters.
Dirty filters can then be cleaned at a convenient time.
1
Open all lower compartment doors (left, middle and right).
2
Pull up and remove each of the compartment air filters. There are two different sizes of air
filters. They are located over vent areas on the inner side of each door.
3
Vacuum or brush each filter thoroughly to remove dust. If excessively dirty, rinse with
deionized water. Vigorously shake residual water from filters. Allow the filter to air dry
completely.
CAUTION
Do not place a damp filter back on the system. Residual moisture may cause
damage to the system. You may find it helpful to order a second set of filters to
use as an alternate. The DxC 600 requires two of PN A08879 and one each of PN
A08851 and 466357. The DxC 800 requires three of PN A08879 and one of PN
466375.
A13914AF
9-41
9
Maintenance
Two-Month Maintenance
4
Lower the clean, dry filters back into position on each door, placing the small filters (1) on top
and the large filter (2) on the bottom. Refer to Figure 9.26.
Slide each filter into position so that the metal grating faces towards the inside of the
instrument when the doors are closed.
Figure 9.26
5
9-42
Close all compartment doors.
A13914AF
Maintenance
Three-Month Maintenance
Three-Month Maintenance
Replace Syringe Plungers
Replace Syringe Plungers
The one reagent and two sample syringe plunger rod assemblies should be replaced every three
months or when signs of wear (discoloration, flaking tips, etc.) are noticed.
The Syringe Plunger replacement procedures apply to the CC Reagent Syringe, the MC Sample
Syringe, and the CC Sample Syringe.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear a wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
Figure 9.27 CC Reagent Syringe (500 μL)
A015942P.EPS
A13914AF
9-43
9
Maintenance
Three-Month Maintenance
Figure 9.28 MC and CC Sample Syringes (100 μL)
3
1
2
A011873P.EPS
1. MC Sample Syringe
2. CC Sample Syringe
3. Syringe Attached to Luer-lock Fitting
Prepare for Maintenance Mode and Remove the Plunger
Before removing the plunger, the plunger rods must be fully extended to the bottom of the syringe
barrels. Follow the steps below to activate the automated Syringe Rod Replacement procedure.
IMPORTANT The system status must be in Standby to access Maintenance mode.
1
Select:
• Utils from the menu bar,
2
•
2 Maintenance,
•
7 Syringe Rod Replacement.
Select Continue to prepare the syringe rod assemblies for maintenance.
OR
Select Cancel to immediately return to the Maintenance menu without performing syringe rod
maintenance.
9-44
A13914AF
Maintenance
Three-Month Maintenance
3
The syringe rods (1) are now positioned for placement.
Figure 9.29
1
A015944P.EPS
4
Unscrew the barrel of the reagent syringe (left back wall) or barrels of two sample syringes
(back wall above modular cups) to release each syringe from the Luer-lock fitting. Refer to
Figure 9.28.
5
Unscrew the round plunger end (1).
Figure 9.30
1
A011874P.EPS
A13914AF
9-45
9
Maintenance
Three-Month Maintenance
6
Separate the plunger rod (3) from the barrel (1) by unscrewing the brown plunger guide (2) at
the base of the barrel and pull the plunger rod out of the barrel. Discard the old plunger rod
(with its guide and base).
The plunger rod cannot be pulled through the brown plunger guide.
Figure 9.31
1
2
3
A014468P.EPS
Install the Syringe
1
Remove the clear sleeve from the new plunger rod tip before installing into the syringe barrel.
2
Moisten the new plunger rod tip with deionized water to limit the amount of air bubbles and
insert the tipped end of the plunger rod into the syringe barrel.
3
Screw the brown plunger guide onto the barrel finger-tight.
CAUTION
When installing the syringes, do not mix the two different syringe sizes. The MC
and CC sample syringes (100 μL) are located on the back wall of the instrument.
The CC reagent syringe (500 μL) is located on the right side of the instrument.
4
To install the assembled syringe:
• Fill the syringe assembly completely full with deionized water.
• Tap the syringe to release bubbles.
• Screw the rounded plunger end onto the adaptor.
• Carefully pull the syringe barrel upward until the syringe Luer-lock fitting is engaged.
• Turn the syringe barrel and lock in place.
9-46
A13914AF
Maintenance
Three-Month Maintenance
5
Select OK when all components have been replaced in the syringe assemblies.
IMPORTANT Always select OK to return the syringe plunger rods to the Home position (top) of the
syringe unit. Select Cancel to close the pop-up window without homing the syringes. If you selected
Cancel from the pop-up window and the Syringe Rod Replacement screen is exited, a motion error
could occur.
6
Select Close to return to the Maintenance menu.
Prime the Syringes
1
Prime syringes 10 times. Do the following:
• Select Utils from the menu bar,
• Select 1 Prime,
• Select CC F2,
• Select Reagent and/or Sample Delivery Subsystem,
• Type 10 in the Number of primes to repeat field,
• Select MC F4,
• Select Sample Delivery Subsystem,
• Select Start Prime.
2
Check the syringes and aspiration lines for air bubbles. If bubbles persist after priming:
Remove syringe and repeat "Install the Syringe," Steps 4–6 and "Prime the Syringes," Step 1.
Return to Home Position
A13914AF
1
Select Instr Cmd from the menu bar.
2
Select 1 Home.
3
All instrument parts return to their home positions.
9-47
9
Maintenance
Four-Month Maintenance
Four-Month Maintenance
Clean the MC Reagent Lines
Clean the MC Reagent Lines
The MC Reagent Lines, Cups, and Stir Bars Cleaning procedure should be performed every four
months for ALBm, BUNm/UREAm, CREm, GLUCm*, PHOSm, and TPm. More frequent cleaning may
be required if erratic results, low results, or reagent cups not filling are experienced.
IMPORTANT The system must be in Standby in order to access Maintenance mode.
Use the MC Maintenance Kit (PN 474198) (includes 3 maintenance bottles with caps and labels, and
a bottle holder) to perform the cleaning.
Prepare the following before beginning this procedure:
Table 9.2 MC Line Cleaning Preparation
MC Module
Prepare
By Diluting
ALBm, BUNm/UREAm, GLUCma,
PHOSm
10% cleaning solution
One part Wash Concentrate II with
nine parts deionized water.
CREm, TPm
1N HCL
One part 6N HCL with five parts
deionized water.
a. Only the GLUCm cup module is on DxC 600 Systems.
• Two of the three maintenance bottles contained in the MC Line Maintenance kit are to be filled
with one of the prepared cleaning solutions. The third maintenance bottle is filled with
deionized water. Self-applied labels are included in the kit to label the contents of each bottle.
• The maintenance bottle caps contain holes or openings into which the reagent straws from the
removed reagent bottles are inserted.
• The maintenance bottles are placed into a bottle holder and the holder is then positioned onto
the bottom frame of the MC reagent compartment. The back of the holder hooks onto the
bottom metal frame of the MC reagent compartment, so that the holder sits upright on or near
the floor.
Cleaning the MC Lines, Cups, and Stir Bars
1
Select:
• Utils from the menu bar,
•
2 Maintenance,
•
4 Cup Maintenance.
* Only the GLUCm cup module is on DxC 600 Systems.
9-48
A13914AF
Maintenance
Four-Month Maintenance
2
Open the left side MC Reagent Compartment door and remove the straws from the reagent
bottles: ALBm, BUNm/UREAm, CREm, GLUCm*, PHOSm, and TPm. Each straw pulls out from the
reagent cap. Wipe the straws dry with lintless tissue.
3
Select all appropriate MC chemistries and Prime5. While all the straws are removed from the
reagent bottles, reagent is primed out from the reagent lines.
Select Close when priming is completed.
4
Using the maintenance bottles included in the MC Maintenance Kit, insert the reagent straws
for:
• GLUCm*, BUNm/UREAm, ALBm and PHOSm into the container of 10% wash concentrate
solution
• TPm and CREm into the container of 1N HCL solution.
Select Prime20. The cleaning solution is primed 20 times. This step takes approximately four
minutes.
5
When priming is complete, let the solutions sit in the cups for 10 minutes.
6
At the end of the 10-minute period, remove straws from the cleaning solution, wipe straws dry,
and insert all straws into the container of deionized water.
Select Close to exit the pop-up confirmation window.
7
Select Prime20. The cups are primed 20 times with deionized water.
8
When priming is complete, remove the reagent straws from the deionized water and wipe
straws dry.
Select Close to exit the pop-up confirmation window.
9
Select Prime5. Air primes through the lines removing residual water from the straws.
10 When priming is complete, insert each reagent straw back into the appropriate reagent bottle.
Verify that the reagent straws are seated properly and reach down into the reagent. Make sure
all reagent bottle caps are securely tightened and no reagent lines are crimped or pinched.
Select Close to exit the pop-up confirmation window.
* Only the GLUCm cup module is on DxC 600 Systems.
A13914AF
9-49
9
Maintenance
Four-Month Maintenance
11 Select Prime20. The cups are primed 20 times with reagent.
Select Close to exit.
12 Replace the glucose sensor and clean the cup and stir bar at this time if the six-month
expiration date has occurred. Refer to Six-Month Maintenance, Replace Glucose Sensor, in this
chapter. If replacement is not necessary, proceed to Step 13.
NOTE Following maintenance, allow 15–20 minutes for the glucose sensor to equilibrate prior to sensor
calibration.
13 Perform the BUNm/UREAm electrode maintenance if maintenance is due at this time. Refer to
Monthly Maintenance, Clean All Cup Modules, in this chapter. While the BUNm/UREAm
electrode is removed, clean the cup and stir bar as instructed in Steps 15 and 16. If BUNm/
UREAm electrode maintenance is not necessary, proceed to Step 14.
NOTE Following maintenance, allow 15–20 minutes for the BUNm/UREAm electrode to equilibrate prior
to chemistry calibration. To ensure there are no bubbles in the BUNm/UREAm cup, immediately prior
to calibration, wrap the tip of an applicator stick with lintless tissue and swab the electrode surface.
14 Select the desired chemistries. Then select Drain.
NOTE It is not necessary to select Glucose if the stir bar was cleaned during the glucose sensor
replacement.
CAUTION
Remove the Glucose sensor before removing the stir bar. To prevent damage to
the glucose sensor membrane tip, do not insert the stir bar removal tool,
applicator stick, or any other object into the glucose reaction cup unless the
sensor has been removed.
CAUTION
Loosen the BUNm/UREAm electrode retainer nut, approximately one-half turn,
and withdraw electrode slightly before removing the stir bar. This prevents
possible damage to the delicate electrode tip.
15 Using the stir bar removal tool (1) Figure 9.32, remove the stir bars from all cups (not necessary
for Glucose if the stir bar was previously cleaned during maintenance). Clean the cups with
cotton swabs moistened with deionized water. Be sure to moisten the swabs before inserting
them into the cups.
9-50
A13914AF
Maintenance
Four-Month Maintenance
Figure 9.32
NOTE If the removed swab from the TPm cup is black, prime TPm again with the 1N HCL solution. Use
additional swabs moistened with 1N HCL solution followed by swabs moistened with deionized water
to repeat the cup cleaning.
16 Clean stir bars with a cotton swab or lintless tissue and deionized water. Use 1N HCL to remove
buildup from CREm and TPm stir bars. Always rinse the cleaning solution from the stir bars
using deionized water.
CAUTION
Make sure the BUNm/UREAm electrode is slightly withdrawn before reinstalling
the stir bar. This prevents possible damage to the delicate electrode tip. After the
stir bar is reinstalled, tighten the retainer nut to prevent leakage.
17 Reinstall the stir bars in the appropriate cups.
NOTE Be careful to return the correct size stir bar to its appropriate cup to assure proper stirring
movement. Replace the stir bar if cracks or burrs are detected. The larger stir bars correspond to the
BUNm/UREAm and GLUCm* cups.
18 Select OK to continue. Observe whether the stir bars are turning properly.
CAUTION
The stir bar may rise in the cup due to air accumulation in the lines. Verify that the
stir bar is positioned down into the bottom of the cup.
* Only the GLUCm cup module is on DxC 600 Systems.
A13914AF
9-51
9
Maintenance
Six-Month Maintenance
19 Select Close when priming is complete to exit the Result pop-up window and select Cancel to
return to the Maintenance menu.
Perform a CUPs Lamp/Sensor Calibration prior to calibrating ALBm, CREm, GLUCm*, PHOSm,
and TPm. Refer to Monthly Maintenance, Calibrate Lamps and Sensor, in this chapter.
Six-Month Maintenance
Replace Calcium and Potassium Electrode Tip
Replace Glucose Sensor
Replace Calcium and Potassium Electrode Tip
The following procedures apply to the preparation and replacement of calcium and potassium
electrodes that are housed in the flow cell. The operator may replace one or both electrode tips at
the same time. Replace the calcium tip at 6 months or 80,000 samples.
Before you install a calcium or potassium electrode tip into the flow cell, record the electrode
number found on the tip. You must enter this number into the Electronic Maintenance Log at the
end of the procedure.
1
Pour ISE Reference Solution (do not dilute) into a clean container to a depth not to exceed two
inches (50 mm).
2
Refer to Figure 9.33. Unpack a new potassium electrode tip (1) (PN 669117) and/or a new
calcium electrode tip (2) (PN 467769).
Unpack each tip and carefully remove the knurled protective cap (3) from membrane end of tip
assembly.
Verify that the black protective cover on the internal threaded connector end of the tip
assembly is in place.
9-52
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Maintenance
Six-Month Maintenance
Figure 9.33
3
Lower electrode tip with the membrane face down into the soaking solution until it floats. For
maximum initial operational stability, the ideal soaking time is 24 hours. The minimum
required time is one hour.
If maximum soaking time is not allowed, the new electrode may require a few hours of
operation to achieve complete electrical stability. During this period of time, more frequent
than normal calibration may be required in response to system error messages. Assay results
are not compromised during this time.
A13914AF
4
After soaking is completed remove the tip from the soaking solution and dry sides using a
lintless tissue. DO NOT touch electrode tip.
5
Remove the back protective cover from the electrode tip. Check for the presence of moisture.
Remove any moisture using lintless tissue. Proceed to ISE Service in this section.
9-53
9
Maintenance
Six-Month Maintenance
ISE Service
The ISE service procedure prevents reagent leakage from the flow cell whenever electrode removal
is required.
1
Loosen the two Phillips screws (1) on the ISE module cover and remove the cover.
Figure 9.34
2
Release the locking pin (1) on the ISE module and lift the module until it clicks into a raised,
locked position. The locking pin is located on the left side of the ISE module on DxC 800 Systems
as shown below. The locking pin is located on the right side of the ISE module on DxC 600
Systems.
Figure 9.35
9-54
A13914AF
Maintenance
Six-Month Maintenance
3
Prevent leakage of reagent from the flow cell.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 3 ISE Service,
— Continue.
The flow cell is prepared for electrode maintenance.
4
Refer to the appropriate electrode procedures for servicing other electrodes (As-Needed/AsRequired Maintenance).
• Chloride Electrode (or Replace the Chloride Electrode Tip)
• CO2 Measuring Electrode (Replace the CO2 Membrane)
• Sodium Electrode (Replace the Sodium Measure/Reference Electrode).
Removal and Installation of the Electrodes
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Disconnect the electrode cable from potassium connector (1) and calcium connector (2).
Figure 9.36
A13914AF
9-55
9
Maintenance
Six-Month Maintenance
2
Loosen the flow cell retaining screw (1) located at the top of the flow cell. This is a captive screw
and cannot be removed from the flow cell. Pull assembly forward and upward to remove.
IMPORTANT Do not disconnect any of the reagent lines attached to the flow cell. Removal of the flow
cell is not necessary for replacing electrodes located on the right side of the flow cell.
Figure 9.37
3
Locate Potassium electrode (1). Remove electrode by loosening the electrode retaining nut.
AND/OR
Locate Calcium electrode (2). Remove electrode by loosening the electrode retaining nut.
Figure 9.38
4
9-56
Remove the retainer nut from the old electrode. Remove the quad-ring (1) from the tip of the
old electrode. Inspect the electrode port if the quad-ring is not on the electrode. Discard the
quad-ring.
A13914AF
Maintenance
Six-Month Maintenance
Figure 9.39
5
Unscrew the old tip from the electrode assembly. Discard the O-ring and the old electrode tip.
6
Install a new O-ring on the presoaked potassium and/or calcium electrode tip and screw onto
electrode body. Install the new quad-ring on the tip of the new electrode.
7
Thoroughly dry the electrode port with lintless tissue.
8
Replace retainer nut on the electrode and insert the new electrode into electrode port. Turn
electrode retainer nut until finger-tight.
9
To test for proper seating of electrode gently pull on electrode body. The electrode assembly
should not move. If the electrode moves, remove it and install it again. Check for an extra or
missing quad-ring if installation is difficult.
10 Reposition flow cell on the mounting panel and tighten the one retaining screw. Reconnect
electrode cable to the appropriate terminal being careful not to bend connecting pin.
11 Select OK in the Maintenance pop-up confirmation window when the electrode service has
been completed and the electrode has been properly replaced.
IMPORTANT Reagents immediately prime through the flow cell.
While system is priming, observe flow cell for leaks. If you notice any leaks, correct the problem
when priming is complete.
A13914AF
9-57
9
Maintenance
Six-Month Maintenance
12 When system has completed priming, select Close to exit the procedure.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
13 Lower the ISE module by releasing the locking pin. Be careful not to pinch tubing as the ISE
module is lowered.
14 Reinstall the ISE module cover.
15 Calibrate all the ISE chemistries. If the calcium electrode tip was replaced, proceed to Step 16.
IMPORTANT Reference drift for the new electrodes may be observed during the first 4-6 hours after
electrode replacement. Results will not be compromised. Recalibrating the chemistry during this
time period helps stabilize the electrode.
16 Following calcium electrode tip replacement and calibration:
• Program and run at least 20 replicates of serum samples for CALC.
• Calibrate calcium.
Replace Glucose Sensor
The Synchron AccuSense glucose oxygen sensor requires no assembly. Each sensor has a gasket
positioned over the membrane tip. The sensor is discarded after six months usage on an instrument,
at which time a new sensor is installed.
Before you install the glucose sensor, record the sensor number found on the sensor. You must enter
this number into the Electronic Maintenance Log at the end of the procedure.
On DxC 800 Systems, the BUNm/UREAm module has an extra glucose sensor connector located next
to the BUNm/UREAm electrode connector. This extra glucose connector can be used to precondition a new glucose sensor prior to installation.
Preparation Prior to Replacement (DxC 800 Systems)
For DxC 600 Systems, follow Steps 1–5 in the table below. Then proceed to Draining the Reaction Cup
for Sensor Maintenance or Replacement.
For DxC 800 Systems, plug the glucose sensor into the empty connector port, (labeled GLU on the
BUNm/UREAm module) 24 hours before glucose sensor installation minimizes sensor drift.
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Six-Month Maintenance
IMPORTANT A new glucose sensor may drift over the first 24 to 48 hours. Always verify control recoveries
after calibration. More Frequent calibration may be required during the first 24 to 48 hours following
installation.
CAUTION
Do not touch membrane tip.
1
Remove the AccuSense glucose oxygen sensor (PN 467432) from the package.
2
Remove the protective cap from the electrode connector.
3
Check the sensor for the presence of the gasket on the membrane tip. If the gasket is missing,
replace it at this time.
4
Visually inspect the sensor for leakage or puncture of membrane.
5
Hold the sensor in a vertical position with the membrane tip pointed down. Tap on the side of
the sensor body to remove any bubbles from the membrane tip.
6
Remove the ISE module and MC module covers.
7
Push the glucose sensor connector into the empty connector port (1) of the BUNm/UREAm
module until the latch clicks.
Figure 9.40
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Maintenance
Six-Month Maintenance
8
Set the glucose sensor down into an empty area of the cup modules. Allow the free standing
sensor to remain connected but not installed for 24 hours. Be careful that the sensor cable is not
pinched or crimped. Reinstall the MC module and ISE module covers.
9
Proceed to Draining Reaction Cup for Sensor Maintenance or Replacement below to replace the
sensor.
Drain the Reaction Cup for Sensor Maintenance or Replacement
IMPORTANT System does not autoprime in Maintenance mode. After completing the maintenance
procedure, or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the
system to Standby.
1
Drain the reagent from the MC cup.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 4 Cup Maintenance.
2
Select Glucose cup to be drained in preparation for maintenance.
3
Select Drain. This drains the cup of reagent so that maintenance may be performed,
OR
Select Cancel to immediately return to the Maintenance menu without draining the cup.
4
Proceed to Sensor Replacement and Stir Bar Cleaning.
Sensor Replacement and Stir Bar Cleaning
Follow the steps below to replace the sensor. After replacement, perform a Sensor Calibration, then
calibrate Glucose.
IMPORTANT When a new sensor is installed, if needed, the reaction cup and/or reagent lines can be cleaned
at this time. Follow the Four-Month Maintenance procedures found in the Four-Month section of this
chapter.
1
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Remove the ISE module and MC module covers.
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Maintenance
Six-Month Maintenance
2
Press the latch (1), which is located on the connector, and pull out to disconnect sensor pin lead
from connector panel.
Figure 9.41
3
Unscrew the sensor retainer nut (1) and withdraw the sensor assembly from chemistry reaction
cup.
Verify that the gasket (2) from the removed sensor has not been left in port opening.
Figure 9.42
4
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Separate the sensor from retainer nut. Discard the old sensor and gasket.
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CAUTION
Reaction cup and stir bar cleaning is recommended whenever the sensor is
replaced. Remove the sensor prior to removing stir bar. To prevent damage to the
glucose oxygen sensor membrane tip, do not insert stir bar removal tool,
applicator stick, or any other object into the glucose reaction cup unless the
sensor has been removed.
5
While the old sensor is removed, clean the cup and stir bar. Using the stir bar removal tool,
remove the stir bar. Clean the stir bar and cup with 10% cleaning solution (one part Wash
Concentrate II, nine parts deionized water). Use cotton swabs moistened with the 10% cleaning
solution to clean the cup. Rinse the cup using applicator swabs moistened with deionized water.
Rinse the stir bar with deionized water. Reinstall the stir bar.
6
This step only applies to DxC 800 Systems. For DxC 600 Systems, proceed to Step 8.
Hold the new sensor, connected to the BUNm/UREAm connector panel, in a vertical position
with the membrane tip pointed downward; tap side of sensor body to remove any bubbles from
the membrane tip.
7
This step applies to DxC 800 Systems only. For DxC 600 Systems, proceed to Step 8.
Disconnect the new prepared glucose sensor from the BUNm/UREAm connector panel.
8
Slide the retainer nut over the cable connector onto the new sensor.
9
Align the keyway on the body of the retainer containing the sensor with the key in the sensor
port and install the sensor assembly. Finger-tighten the retainer nut.
10 Reconnect the pin lead into the glucose connector panel by aligning the latch on the connector
with the notch on the connector panel. Push the pin lead into the connector panel until the
latch clicks.
11 Select OK in the Maintenance pop-up confirmation window when replacement is complete. The
Glucose cup is primed five times with water.
While module is priming:
• Observe the reagent line and Glucose reaction cup to determine there are no leaks. If any
leaks are noticed, correct the problem.
• Observe the stir bar to verify that it is rotating properly.
12 Select Close when priming has completed to exit the Result pop-up window.
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13 Select Cancel to return to the Maintenance menu.
14 Reinstall the MC module and ISE module covers.
15 Proceed to the Calibrate Lamps and Sensor in the Monthly Maintenance section of this chapter
As-Needed/As-Required Maintenance
Replace the Chloride Electrode Tip
Replace the Sodium Measure/Reference Electrode
Replace the CO2 Membrane
Clean the EIC Port
Clean the CO2 Alkaline Buffer Lines
Clean the ISE Drain
Flush the Flow Cell (Manual)
Clean the ISE Flow Cell Using Clenz Solution
Flush the Sample and Reagent Probe
Replace the Sample and Reagent Probe
Clean the CC Sample Probe, Reagent Probes and Mixers
Clean the MC Sample Crane and Collar Assembly
Clean the Precipitate in PHOSm (DxC 800 Only)
Inspect the Cuvette Washer Probe
Wash All Cuvettes With System Wash
Wash the CC Reagent Cuvettes with CCWA
Clean the Work Surfaces
Decontaminate the Sample Racks
Decontaminate the Instrument
Replace the CTS Wick
Replace ISE Drain Pump Tube
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As-Needed/As-Required Maintenance
Introduction
As-Needed/As-Required Maintenance contains miscellaneous maintenance procedures which may
be performed on an as-needed basis or procedures that may be performed on a regular basis as
preventive service maintenance.
The As-Required Maintenance includes items that are maintained on an interval schedule, and are
normally performed as preventive service maintenance. The As-Required procedures are grouped
together with As-Needed Maintenance, categorized by subsystem instead of by interval.
Record any As-Needed or As-Required Maintenance on the Instrument Action Log section of EMaintenance (On-screen Electronic-Maintenance). Select (F1) to access the log on the Maintenance
screen.
Action Log
The Maintenance Screen includes a free-text Action Log function that allows you to create notes
regarding maintenance issues and procedures. To display the Maintenance Action Log screen, select
the Utils icon, then select 2 Maintenance, then Action F1. Use the Action Log to record any As-Needed
or As-Required maintenance you perform.
Replace the Chloride Electrode Tip
Prepare the CL electrode tip as follows prior to removal and installation:
1
Unpack a new chloride electrode tip (PN A10867). Carefully remove the knurled protective cap
from membrane end of tip assembly.
2
Perform the following ISE Service procedure.
ISE Service Procedure
The ISE service procedure prevents the flow cell from leaking reagent when an electrode is removed
from the instrument.
9-64
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Proceed to Replacing the Chloride Electrode.
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Maintenance
As-Needed/As-Required Maintenance
Replace the Chloride Electrode
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Disconnect the electrode cable from the CL connector.
2
Loosen the flow cell retaining screw (1) located at the top of the flow cell. This is a captive screw
and cannot be removed from the flow cell. Pull assembly forward and upward to remove.
IMPORTANT Do not disconnect any of the reagent lines attached to the flow cell. Removal of the flow
cell is not necessary for replacing electrodes located on the right side of the flow cell.
Figure 9.43
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Maintenance
As-Needed/As-Required Maintenance
3
Locate the Chloride electrode (1). Remove electrode by turning the electrode retaining nut.
Figure 9.44
A015946P.EPS
4
Remove the retainer nut from the old electrode. Remove the quad-ring (1) from the tip of the
old electrode. Inspect the electrode port if the quad-ring is not on the electrode. Discard the
quad-ring.
Figure 9.45
9-66
5
Unscrew the old tip from the electrode assembly. Discard the O-ring and the old electrode tip.
6
Install a new O-ring on chloride electrode tip and screw the tip onto electrode body.
7
Completely dry the electrode port with lint-free tissue.
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Maintenance
As-Needed/As-Required Maintenance
IMPORTANT Do not scratch the electrode port.
8
Install the retainer nut and a new quad-ring on the electrode and insert the new electrode into
electrode port. Turn electrode retainer nut until finger-tight.
9
Gently pull on electrode body to test for proper seating of electrode. The electrode assembly
should not move. If electrode moves, remove it and install it again. Check for an extra or missing
quad-ring if installation is difficult.
10 Reposition flow cell on the mounting panel and tighten the one retaining screw. Reconnect
electrode cable to the appropriate terminal being careful not to bend the connecting pin.
11 Select OK in the Maintenance pop-up confirmation window when the electrode service has
been completed and the electrode has been properly replaced.
IMPORTANT Reagents immediately prime through the flow cell.
While the system is priming, observe the flow cell for leaks. Stop the priming if any leaks are
noticed and correct the problem.
12 When the system has completed priming, select Close to exit the procedure.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
13 Lower the ISE module by releasing the locking pin. Be careful not to pinch tubing as the ISE
module is lowered.
14 Reinstall the ISE module cover.
15 Calibrate all ISE chemistries. A reference drift for new electrodes may be observed during the
first 4–6 hours after electrode replacement. Results will NOT be compromised. Recalibrating the
chemistry during this time period helps stabilize the electrode.
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Replace the Sodium Measure/Reference Electrode
The Sodium Measuring Electrode must be prepared before installation of a new electrode.
Materials Required:
• Beaker
• Na/K-free filter paper
• Phillips screwdriver
Follow the steps below to prepare the Sodium electrode (PN 668295).
1
In a small beaker, prepare a soft bottom lining using crumpled multiple layers of Na/K-free
filter paper (2).
Pour ISE Reference solution (do not dilute) into the beaker to a depth not to exceed two inches
(50 mm) (1).
Figure 9.46
2
Unpack a new sodium electrode. Carefully remove black protective cap covering glass tip.
IMPORTANT If maximum soaking time is not allowed, the new electrode may require a few hours of
operation to achieve complete electrical stability. During this period, more frequent calibration than
normal may be required in response to system error messages. Assay results are not compromised during
this time.
3
Soak the electrode:
• 1 hour minimum
• 24 hours maximum
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4
Lower the electrode face (2) into the soaking solution until only the tip is covered by the soaking
solution (1).
Figure 9.47
Removal and Installation of the Sodium Electrode
For access to the Sodium Reference electrode, instrument covers must be removed. To remove the
ISE Module cover, follow the steps below. The instrument status must be Standby to perform this
procedure
CAUTION
To prevent damage due to electrical static discharge (ESD), wear a wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter..
1
Loosen the two Phillips screws on the ISE Module cover and remove the cover.
2
Release the locking pin on the ISE Module and lift the module until it clicks into a raised, locked
position.
3
Drain the flow cell.
Select:
• Utils from the menu bar,
A13914AF
•
2 Maintenance,
•
3 ISE Service.
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9
Maintenance
As-Needed/As-Required Maintenance
4
Select Continue. This drains the flow cell of reagent so that the electrode may be replaced.
OR
Select Cancel to immediately return to the Maintenance menu without draining the flow cell.
IMPORTANT Do not disconnect any of the reagent lines attached to the flow cell.
5
Disconnect the electrode cable (1).
Figure 9.48
6
Loosen the flow cell retaining captive screw (1) located at the top of the flow cell. Pull flow cell
assembly forward.
Figure 9.49
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As-Needed/As-Required Maintenance
7
Unscrew the electrode retainer nut (1) and withdraw the electrode (2) from the flow cell.
Verify that the quad-ring from the removed electrode has not been left in port opening.
Figure 9.50
8
Remove the retainer nut from the old electrode and install on new electrode.
9
Examine the electrode tip. If an air bubble is seen inside the tip, hold the electrode cable near
the end and spin the electrode for a few seconds. The bubble should be pushed back inside the
electrode and remain there away from the tip.
10 Using a lintless tissue, carefully and thoroughly dry the electrode sides and electrode port.
IMPORTANT Do not touch the electrode tip.
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Maintenance
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11 Install a new quad-ring (1) on the electrode.
Insert the sodium electrode into the flow cell. Insert retainer nut (2) and turn until finger-tight.
Figure 9.51
12 To test for proper seating of electrode, gently pull on electrode body. The electrode assembly
should not move. If the electrode moves, remove it and try to install it again. If installation is
difficult, check for an extra or missing quad-ring.
13 Reposition the flow cell on mounting panel and tighten the retaining screws.
14 Reconnect the electrode cable to the appropriate connector.
15 Select OK in the Maintenance pop-up confirmation window.
16 Select Close in the Result pop-up window. Proceed to Prime the Flow Cell.
Prime the Flow Cell
1
Prime the flow cell:
• Select Utils from the menu bar,
• Select 1 Prime,
• Select MC F4,
• Prime ISE ALL.
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2
Type 15 in the Number of primes to repeat field.
3
Select Start Prime.
IMPORTANT While priming, inspect flow cell for leaks. If any leaks are noticed, discontinue priming and
correct the problem.
Replace the ISE Module Cover
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
1
Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
2
Reinstall the ISE module cover.
Replace the CO2 Membrane
The permeability of the CO2 membrane may change depending on usage and time. Changes in the
membrane could be caused by a coating build-up, wear, or general deterioration. Replace the CO2
membrane as needed whenever these conditions occur.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
Remove the Old CO2 Membrane
A13914AF
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
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Maintenance
As-Needed/As-Required Maintenance
3
Prepare for ISE maintenance and disable autoprime.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 3 ISE Service,
— Continue.
The flow cell is prepared for maintenance.
4
Disconnect the CO2 Measuring Electrode cable (1).
Figure 9.52
1
A010980P.EPS
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Maintenance
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5
Locate the CO2 measuring electrode. Place absorbent tissue beneath the CO2 electrode port.
Using hemostats, clamp off reagent Lines #33 (1) and #32 (2) as closely as possible to the CO2
electrode. (Line #32 connects as a loop to the CO2 reference electrode.) Remove electrode by
turning the electrode retainer nut.
Figure 9.53
6
Remove electrode retainer nut (1). Remove membrane as follows:
• Separate the membrane retainer (3) assembly from the electrode.
• Remove the quad-ring (4) from the retainer. Inspect the electrode port if the quad-ring is
not on the electrode.
• Separate the membrane retainer from the membrane clamp (2) and pull apart. Discard the
used membrane.
Figure 9.54
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Maintenance
As-Needed/As-Required Maintenance
Prepare the New CO2 Measuring Electrode Membrane
1
Use tweezers to remove a new membrane (PN 661750) from the package in the Maintenance Kit.
Rinse the membrane thoroughly, on both sides, with deionized water. Gently dry the membrane
with lintless tissue.
Use the packaged membranes that are separated by pink spacers.
Figure 9.55
2
Place the membrane clamp (2) on a flat surface. Using tweezers, carefully center the membrane
(1) on top of the membrane clamp.
Figure 9.56
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3
Center the membrane retainer (1) over the membrane clamp (3). Press the membrane retainer
into the clamp, thus securing the membrane (2).
Figure 9.57
4
Place the retainer assembly upside down on the work surface so the clamp is on top and retainer
on the bottom. Grasp the electrode carefully and press it firmly against the membrane and into
the membrane clamp.
Figure 9.58
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Maintenance
As-Needed/As-Required Maintenance
5
Inspect the membrane to verify that it is not broken, or wrinkled and is centered properly with
no uneven edges protruding. If membrane is not centered correctly or is damaged, repeat Steps
1-4 with a new membrane.
Figure 9.59
CAUTION
Do not touch membrane surface when installing the quad-ring.
6
Reinstall the quad-ring (1) onto the membrane retainer. When installed, the quad-ring must be
on the very end of the CO2 electrode. This ensures a proper fluid seal when the electrode is
installed in the flow cell.
Figure 9.60
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Reinstall the CO2 Measuring Electrode
CO2 Measuring Electrode Reinstallation
1
Using a lintless tissue, carefully and thoroughly dry the electrode assembly and electrode port.
Electrode and electrode port must be completely dry before reinstallation of the electrode.
2
Insert the CO2 electrode onto the electrode port being careful to align key pin on electrode with
keyway in the electrode port. Insert retainer nut and turn until finger-tight.
3
To test for proper seating of electrode, gently pull on electrode body. The electrode assembly
should not move. If the electrode moves, remove it and try to install it again. If installation is
difficult, check for an extra or missing quad-ring.
4
Reconnect tubing lines #33 and #32 to the electrode. Remove hemostats. Make sure the tubings
fit tightly on the electrode port.
5
Reconnect the electrode cable to the appropriate connector.
6
When the necessary electrode service is completed and the electrode is properly replaced,
select OK to exit the Maintenance pop-up confirmation window.
NOTE While the system is priming, observe flow cell for leaks. Stop priming if any leaks are observed.
7
Select Close in the Result pop-up window to exit the ISE Service screen.
8
Adjust the alkaline buffer damper volume. Refer to Adjust the Fluid Level of the Alkaline Buffer
Damper Assembly under Monthly Maintenance, in this chapter.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
9
Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
10 Reinstall the ISE module cover.
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Maintenance
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11 Calibrate all the ISE chemistries.
Clean the EIC Port
Flushing of the EIC ports should be performed if the Electrolyte Injection Cup (EIC) becomes
plugged and overflows, or as part of troubleshooting for erratic electrolyte results. The following
items should be available before starting this procedure:
• 10% bleach* solution (one part 5.25% sodium hypochlorite (PN A32319), combined with nine
parts deionized water). Prepare fresh. Use within 24 hours.
• 70% isopropyl alcohol
• 20 or 30 mL irrigation syringe
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Prepare ISE for maintenance and disable autoprime.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 3 ISE Service.
• Select Continue to prepare for maintenance.
* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).
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4
Disconnect the solenoid valves, located on each side of the EIC, at the valve connector (1) as
shown below on DxC 800 Systems. The connector is located near the EIC ports where the ends
of the two solenoid valve cables meet. For DxC 600 Systems, trace the solenoid wiring to its
source and disconnect. Pull apart the valve connector to disconnect.
Figure 9.61
5
Carefully remove the Phillips screw and washer (1) (screw removed in figure) located on the top
of the EIC. Lift off the EIC (two sections with solenoid valves (2) attached) from the drip tray (3).
IMPORTANT DO NOT REMOVE the two screws on the drip tray. Removal or repositioning of the drip tray
requires an MC sample probe alignment.
Figure 9.62
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Maintenance
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6
Place absorbent tissue underneath the EIC port area. Place clamps or hemostats on lines #18 (1),
#24 (2), #23 (3), and #26 (4), near the EIC ports. Remove EIC lines from all the ports #18, #24, #23,
#26, and #15 (5).
Figure 9.63
7
Carefully loosen the two screws (1) from the solenoid valve located on the back side of the EIC.
Remove the solenoid valve and set aside.
Figure 9.64
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Maintenance
As-Needed/As-Required Maintenance
8
Hold the removed EIC over a sink or absorbent tissue. Using a 20 or 30 mL irrigation syringe
filled with 10% bleach solution, insert the tip of the syringe into the valve port opening (1).
Figure 9.65
9
Flush the 10% bleach solution through the valve port. This flushes the sample inject area. Allow
the bleach solution to sit for one minute.
The one-minute waiting period applies only to the 10% bleach solution, and not to the following
deionized water or 70% isopropyl alcohol.
10 Repeat the flushing procedure through the valve port using deionized water.
11 Repeat the flushing procedure through the valve port using 70% isopropyl alcohol.
12 Repeat the flushing procedure through the valve port using deionized water.
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Maintenance
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13 Using the syringe filled with 10% bleach solution, connect the syringe tip over the flow cell exit
port #23 (1).
Figure 9.66
14 Flush the 10% bleach solution through the flow cell exit port. This flushes the area between the
valve port and flow cell exit port. Allow the bleach solution to sit for one minute.
The one-minute waiting period applies only to the 10% bleach solution, and not to the following
deionized water or 70% isopropyl alcohol.
15 Repeat the flushing procedure through the flow cell exit port using deionized water.
16 Repeat the flushing procedure through the flow cell exit port using 70% isopropyl alcohol.
17 Repeat the flushing procedure through the flow cell exit port using deionized water.
18 Thoroughly dry the EIC and attached solenoid valve using a dry lintless tissue. Wipe the drip
tray with deionized water and lintless tissue. Thoroughly dry the drip tray.
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19 Reinstall the solenoid valve to the back side of the EIC. Orient the valve to align the guide pins
(1) on the valve with the appropriate holes (2) on the EIC. Press the EIC and valve firmly together
for a flush fit. Tighten the two screws on the valve, turning the screws until resistance is felt. At
this point, tighten each screw 1/8 of a turn further. DO NOT overtighten the screws.
Figure 9.67
20 Reattach lines #18, #24, #23, #26, and #15 to the EIC ports. Refer to Figure 9.63.
21 Remove clamps from lines #18, #24, #23, and #26.
22 Reattach the EIC top sections to the drip tray. Align the guide pin on the bottom of the EIC to
the hole on the drip tray and press the EIC down onto drip tray. Tighten the Phillips screw on
the top of the EIC.
23 Reconnect the solenoid valves at the valve connector.
24 Select OK to close the Maintenance pop-up confirmation window.
IMPORTANT Reagents immediately prime through the flow cell.
25 Select Close in the Result pop-up window to exit the ISE Service screen.
26 Observe EIC, lines and connections to verify that reagents are flowing properly with no leaks.
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CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
27 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
28 Reinstall the ISE module cover.
29 Calibrate the ISE chemistries.
Clean the CO2 Alkaline Buffer Lines
Bleaching of the Alkaline Buffer reagent straw and line is recommended to clean the reagent line
whenever the buffer is prematurely decolorizing (fading).
Prepare a 10% bleach* solution (one part 5.25% sodium hypochlorite (PN A32319), combined with
nine parts deionized water). Use within 24 hours.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Loosen the two Phillips screws from the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Disconnect line #33 from the alkaline buffer reagent bottle and place the line in a small
container. (The container is used to catch the line drainage while priming).
4
Unscrew and remove the alkaline buffer reagent bottle cap and insert the straw into a container
of 10% bleach solution.
* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).
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5
Prime the ISE CO2 Alkaline Buffer 20 times.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE CO2 Alkaline Buffer check box.
• Type 20 in the Number of primes to repeat field.
• Select Start Prime. Wait for prime cycles to finish.
6
Remove the alkaline buffer reagent straw from the bleach solution and insert the straw into a
container of deionized water.
7
Prime the ISE CO2 Alkaline Buffer 25 times as follows:
• Select the ISE CO2 Alkaline Buffer check box.
• Type 25 in the Number of primes to repeat field.
• Select Start Prime. Wait for prime cycles to finish.
8
Remove the alkaline buffer reagent straw from the deionized water and dry the straw with
lintless tissue.
9
Reinstall the alkaline buffer reagent cap and straw onto a new bottle of alkaline buffer reagent.
10 Prime the ISE CO2 Alkaline Buffer 15 times as follows:
• Select the ISE CO2 Alkaline Buffer check box.
• Type 15 in the Number of primes to repeat field.
• Select Start Prime. Wait for prime cycles to finish.
11 Reconnect line #33 to the reagent bottle. If the tubing does not make a tight fit, cut off the tip
of the end of the tubing and reconnect.
12 Prime the ISE CO2 Alkaline Buffer 5 times as follows:
• Select the ISE CO2 Alkaline Buffer check box.
• Type 5 in the Number of primes to repeat field.
• Select Start Prime. Wait for prime cycles to finish.
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13 Perform a reagent load if a new bottle of alkaline buffer reagent is loaded, and adjust the
alkaline buffer damper volume.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
14 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
15 Reinstall the ISE module cover.
16 Calibrate CO2 chemistry.
Clean the ISE Drain
With constant use, the flow cell drain can develop a salt bridge, possibly causing recovery anomalies
for NA and CL. To prevent this build up from occurring, the drain should be cleaned periodically.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Prepare for ISE maintenance and disable autoprime.
Select:
• Utils from the menu bar,
•
2 Maintenance,
• 3 ISE Service.
• Continue to drain the flow cell and prepare for maintenance.
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4
Loosen the screw at drain top (1). Gently grasp the ISE drain top and remove the top. Do not lose
the attached metal drip screen (2). (The top may require slight wiggling back and forth to
remove.)
Figure 9.68
5
Carefully set aside the drain top (with tubing #22 attached).
6
Remove the drain tube (1) from the drain.
Figure 9.69
7
A13914AF
Using four to five cotton swabs soaked with deionized water, clean the inside of the lower drain
and the top of drain.
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8
Reinstall the cleaned drain tube, or install a new drain tube (PN 472698). Insert the drain tube
down through the O-ring until it sits flush on the bottom of the ISE drain.
NOTE If the fit is too snug to insert the drain tube, it may be necessary to lubricate the O-ring on the
inside of the lower drain. Without removing the O-ring, apply a thin coat of Silicone compound to the
O-ring area inside the lower drain, prior to inserting the drain tube.
9
Clean the ISE drain top using a lintless tissue soaked with deionized water. Thoroughly wipe dry
the ISE drain.
IMPORTANT Do not pinch, damage, or disconnect the adjacent connector wires while reinstalling the drain
top.
10 Reinstall the ISE drain top onto the drain. Align the two posts extending from the bottom of the
drain top, with the holes in the acrylic drain mount, and gently lower the drain top until it sits
flush (with no gaps) on the mount.
Tighten the screw at drain top.
11 Select OK to exit the Maintenance pop-up confirmation window when procedure is complete.
12 After priming is complete, select Close in the pop-up Results window to exit the ISE Service
screen.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
13 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
14 Reinstall the ISE module cover.
15 Calibrate all the ISE chemistries.
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Flush the Flow Cell (Manual)
Flushing the flow cell is recommended for troubleshooting drift, back-to-back errors and range
errors that may be caused by plugs or debris lodged in the electrode ports. The following items
should be available before starting this procedure:
• Flow cell flush kit (PN 473181)
• 20 mL syringe
• hemostat
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Prepare for ISE Maintenance and disable autoprime.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 3 ISE Service.
• Select Continue to drain the flow cell and prepare for maintenance.
4
A13914AF
Use a hemostat to clamp off line #35 at the top of the flow cell. Line the area under the flow cell
with absorbent tissue.
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5
Remove line #23 from the bottom of the flow cell. Attach the connector fitting (1) on the small
diameter tubing, included in the Flow cell flush kit, to the syringe. Connect the open end of the
tubing to the bottom of the flow cell.
Figure 9.70
6
Without removing the hemostat, remove line #35 from the top of the flow cell. Remove line #27
from the front of the flow cell in order to allow residual acid to leak out.
7
Draw back on the syringe. This withdraws any remaining solution left in the flow cell and
removes any material that can be causing the occlusion of the small lumen.
NOTE The procedure may be concluded here if the problem has been resolved. Proceed to Step 10.
If the problem is not resolved, proceed to the next step.
8
9-92
Re-attach line #27 to the front of the flow cell. Remove the syringe and empty the contents. Fill
the syringe with ISE Buffer.
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9
Remove Line #35 from the top of the flow cell. Attach the connector fitting (1) of the large
diameter tubing, included in the Flow cell flush kit, to the syringe. Connect the open end of the
tubing to the top of the flow cell. Flush the buffer through.
Figure 9.71
10 Reattach the lines to the flow cell and remove the hemostat.
11 When all components are in place for the flow cell select OK to prime the flow cell. Select Close
in the pop-up window to exit the ISE Service screen.
12 Prime the flow cell 5 times.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE All check box.
• Type 5 in the Number of primes to repeat field.
• Select Start Prime.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
13 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
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14 Reinstall the ISE module cover.
15 Calibrate the ISE chemistries.
Clean the ISE Flow Cell Using Clenz Solution
The Flow Cell Cleaning procedure helps to maintain the performance of the ISE chemistries. The
procedure should be performed if one or more of the following conditions is seen:
• A yellow discoloration at, or above, the Flow Cell CO2 Acid port.
• A white coating throughout the flow cell.
• Continuous "CAL REF DRIFT"s which generate suppressed results.
• Low recovery for successive NA or K results.
• Excessive calibration failures due to range or span errors.
• Under extreme situations, control and sample recoveries vary, due to inaccurate calibrations.
• As instructed by Hotline or Service Engineer.
IMPORTANT System does not autoprime in maintenance move. After completion a maintenance procedure,
or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the system to
Standby.
A calibration of ALL flow cell chemistries is required after completion of the cleaning procedure.
Materials Required:
• Diluted Clenz Solution freshly prepared by adding 10 drops of Clenz Solution Concentrate (PN
664090) to 5 mL Saline.
• One 5 mL syringe.
• Flow cell cleaning kit (PN 473181) - optional.
Completely fill the syringe with diluted Clenz Solution. Tap syringe gently to remove any air
bubbles.
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Flow Cell Cleaning Procedure
CAUTION
To prevent damage due to electrical static discharge (ESD), wear the wrist ground
strap when you perform this procedure. for further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
1
Loosen the two Phillips screws on the ISE module cover and remove the cover.
2
Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked
position.
3
Prepare the flow cell for maintenance.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 3 ISE Service,
— Continue.
4
Remove line #23 from the bottom of the flow cell (see Figure 9.72). (A Luer connector and small
diameter tubing may be found in the Flow Cell Cleaning Kit (PN 473181)). Connect the open end
of the tubing to the bottom of the flow cell.
Figure 9.72 ISE Flow Cell
1. Line 23
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Maintenance
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5
Slowly inject the Diluted Clenz Solution into the flow cell. Be sure that liquid completely fills
the flow cell and that there are no air bubbles in the line. DO NOT REMOVE SYRINGE FROM THE
LINE.
6
Allow the system to stand idle for five minutes. DO NOT REMOVE SYRINGE FROM THE LINE
DURING THIS TIME.
7
Pull back on the syringe plunger to completely remove the Clenz Solution from the flow cell.
8
Disconnect the tubing from the bottom of the flow cell.
9
Reconnect line #23 to the bottom of the flow cell.
10 When the necessary cleaning is completed, select OK to close the dialog box.
IMPORTANT Reagents immediately prime through the flow cell.
While the flow cell is priming, verify there are no fluid leaks.
11 After the pop-up message appears, select Close to exit the ISE Service screen.
12 Rinse the syringe, connector, and tubing with deionized water. Dry and store for future use.
13 Prime the flow cell.
• Select:
— Utils from the menu bar,
— 1 Prime,
— MC F4,
— ISE All check box.
• Type 20 in the Number of primes to repeat field.
• Select Start Prime.
CAUTION
Pinch hazard. Keep fingers clear of the ISE module as you lower it.
14 Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module
is lowered.
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15 Reinstall the ISE module cover.
16 Calibrate all ISE chemistries twice. Run controls to verify ISE performance.
IMPORTANT By calibrating twice, all fluids are delivered to the flow cell in a standard manner and the
electrodes are stabilized more quickly.
Flush the Sample and Reagent Probe
The sample or reagent probes may need flushing when the probe becomes blocked or when
troubleshooting recommends flushing to clean the inside of the probe.
Materials Required:
• Probe Cleaner Tubing Assembly (PN 756613)
• Small cup for collecting wash solution
• 50 mL of 10% dilution of Wash Concentrate II solution per probe
CAUTION
To prevent damage due to electrical static discharge (ESD), wear a wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
A13914AF
1
Press the STOP button on the instrument to stop all motors.
2
Place a small cup under the collar wash of the probe to be flushed.
3
Unscrew the upper fitting (1) above the bead assembly to disconnect the DI water line. Do not
remove the level sense bead (2) otherwise alignments will be required.
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Figure 9.73
1
2
A015947P.EPS
4
Connect the Probe Cleaner Tubing Assembly to the top of the probe assembly where the fitting
for the probe tubing was removed in Step 3. Tighten no more than finger tight.
5
Fill a 10 mL syringe with diluted wash solution. Connect the syringe to the other end of the
probe cleaning assembly.
6
Dispense all of the syringe contents through the probe into the collection cup. Repeat until
50 mL has been dispensed. Empty the collection cup as often as necessary.
7
Remove the cleaning assembly from the probe. Clean the probe tubing fitting with a cotton
swab wrapped in lintless tissue and moistened with deionized water. Dry the probe tube fitting
with a cotton swab wrapped in lintless tissue.
8
Reconnect the DI water line into the black fitting at the top of the probe.
9
Home the instrument.
• Select Instr Cmd.
• Select 1 Home.
10 Prime the sample and reagent probes by performing the probe cleaning procedure listed in
Weekly Maintenance, Clean Flow Cell, Cups and CC Probes/Mixers (Automated).
NOTE Run controls to make sure that the cleaning completely removed the blockage.
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Replace the Sample and Reagent Probe
The Sample or Reagent Probe should be replaced when visual inspection or chemistry performance
indicates there is a compromised probe condition (scratches, pits or blockage). These instructions
cover installation of the replaceable style probe.
CAUTION
To prevent damage due to electrical static discharge (ESD), wear a wrist ground
strap when you perform this procedure. For further instructions, refer to Basic
Laboratory Practice in the beginning of this chapter.
Replace the Old Probe
1
Press the STOP button on the instrument to stop all motors.
2
Using a 3/8 inch open end or adjustable wrench, loosen the nut (1) at top of probe.
Figure 9.74
1
A007413P.EPS
A13914AF
3
Pull downward first on the probe, then up and to the side to remove the probe from the collar
wash.
4
Check to make sure the O-ring is on the nut. If the O-ring stayed inside the level sense bead,
bump it loose with a wooden applicator stick.
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Install the New Probe
1
Remove the protective sleeve from the probe tip and slip the probe down into the collar wash
block with the threaded end upward.
2
Install a new O-ring in the groove on the tip of the nut. It is OK to reuse an old O-ring if the new
O-ring is lost.
3
Slip the probe up, into the level sense bead fitting being careful not to lose the O-ring.
4
Tighten the probe with a wrench until it makes solid contact and locks within the fitting.
5
Wipe the outside and bottom portion of the probe with 70% isopropyl alcohol. Proceed to
Additional Procedures in this section.
Additional Procedures
Home, prime and align the system to resume proper system operation.
1
2
Select:
•
Instr Cmd.
•
1 Home.
Select:
• Utils from the menu bar,
•
1 Prime. Prime the probe that was replaced one time and watch for leaks or drips.
— If replacing the MC Sample Probe
·
Prime the MC Sample Delivery Subsystem
— If replacing the CC Sample Probe
·
Prime the CC Sample Delivery Subsystem
— If replacing the Either CC Reagent Probe
·
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Prime the CC Reagent Delivery Subsystem
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Maintenance
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3
Follow the appropriate alignment procedure as described in the UniCel DxC Synchron Clinical
Systems Reference Manual, System Tools.
• If the current probe is re-installed after inspection without moving the bead assembly,
— No alignments required.
• If a new MC Sample Probe is installed,
— MC Sample Probe Vertical Home and Wash
— MC Sample Probe Sample Height
— MC Sample Probe Cup Height
— MC Sample Probe EIC Height
• If a new CC Sample Probe is installed,
— CC Sample Probe Vertical Home and Wash
— CC Sample Probe Cuvette Height
— CC Sample Probe Sample Height
• If a new Reagent Probe is installed in either position,
— Reagent Probe (A or B) Vertical Home and Wash
— Reagent Probe (A or B) Height in Cuvette
— Reagent Probe (A or B) Height in Cartridge
• If the bead assembly is removed or repositioned,
— all rotary and vertical alignments for that probe must be performed.
When you perform the Vertical Home and wash alignment and verify the proper probe position in
the collar wash, follow the instructions on the screen. The proper positions are indicated below.
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Figure 9.75 CC and MC Sample Probe
1
2
3
4
5
A007375L.EPS
1. Sample Probe
2. Collar Wash
3. Waste Port
4. Wash Port
5. Probe tip is even to the bottom
edge of the wash port
Figure 9.76 Reagent Probe A and B
1
2
3
5
4
A007376L.EPS
1. Reagent Probe
2. Collar Wash
3. Waste Port
4. Wash Port
5. Probe tip is even to the middle of
the wash port
Confirm Instrument Performance
When the probe installation is complete, run the controls to confirm proper instrument
performance. If the controls are out but there are no visible leaks, recalibrate all chemistries and
rerun controls.
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Clean the CC Sample Probe, Reagent Probes and Mixers
The following procedure describes the automated procedure to wash the CC sample and reagent
probes and mixers. This routine takes the system approximately 15 minutes.
IMPORTANT The System does not autoprime in Maintenance mode. After completing a maintenance
procedure, or when a procedure is aborted, exit the Maintenance menu to resume autoprime and return
the system to Standby.
Materials Required:
• CCWA cartridge (PN 657133)
1
Load the CCWA cartridge onto the system.
• Select:
— Rgts/Cal from the menu bar,
— An empty chem position to load (CC side),
— Load F1. Scan Chemistry Wash Solution Cartridge (CCWA).
2
The Wash procedure is accessed, select:
• Utils from the menu bar,
•
2 Maintenance,
•
2 Cartridge Chemistry Probe Cleaning,
OR
Type 2 in the Procedure No. field and press (Enter) .
Follow all instructions on the screen.
3
To perform the procedure:
• Select Continue.
OR
• Select Cancel to exit this screen without performing the procedure.
IMPORTANT If desired, you may exit this procedure at any time before it is completed. To exit select
STOP on the instrument; wait for the system to finish processing. To return the system to Standby,
select Instr Cmd from the menu bar, then select 1 Home.
A pop-up message confirms that probe and mixer cleaning is complete.
• Select Close to exit.
4
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At the completion of this procedure, the Maintenance menu appears.
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Maintenance
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5
Exit the Maintenance menu.
IMPORTANT To resume autoprime and return the system to Standby, you must exit the Maintenance
menu.
6
Remove the CCWA cleaning solution cartridge.
• Recap the cartridge and store at room temperature. Reuse at the next maintenance
interval.
• Discard the cartridge after 180 days.
Clean the MC Sample Crane and Collar Assembly
Perform the MC Sample Crane and Collar Wash Assembly procedure whenever:
• A build up of residue is observed on the collar wash assembly, or
• It is suspected that a dirty collar wash assembly is causing increased level sense errors.
Materials Required:
• One sample rack
• One 2 mL cup
• Undiluted household bleach* (Sodium hypochlorite 5.25%) (PN A32319)
1
Select:
• Utils from menu bar,
•
4 Diagnostics,
• Functional Area 1 Sample System,
• Subfunctional Area 1 MC Chemistry Sample Crane,
• Test Number 1 Level Sense Test.
2
Type the Rack ID into the Rack ID field. Select the appropriate Rack Position. Select Cup as
container type.
3
Fill the cup with bleach. Place it in the specified rack and position, and then place the rack in
the autoloader.
4
Select Start.
The System automatically loads the rack and the MC probe aspirates the sample.
* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).
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If errors occur while the procedure is being performed, the error condition appears in the
message bar at the bottom of the screen. Status for non-compromised testing should be OK.
Ignore the values shown in the fluid level column.
5
Allow the test to continue until 10 to 12 data points are shown in the fluid level column. (The
MC sample probe has aspirated approximately 12 times.) Select Stop to end the testing. The test
rack automatically unloads.
6
Select Close to exit the screen. Then select Exit to leave the Diagnostic screen.
7
Select:
• Utils from the menu bar,
•
1 Prime,
•
MC F4,
• Sample Delivery Subsystem check box. Type 5 in the Number of primes to repeat field.
•
Start Prime. The collar wash assembly is rinsed with water.
If necessary, clean the exterior of the MC sample probe. Refer to Weekly Maintenance, Clean
Probes (Exterior) in this chapter.
Clean the Precipitate in PHOSm (DxC 800 Only)
The phosphorus (PHOSm) cup should be cleaned when protein precipitate accumulates at the top
of the liquid surface. The precipitate may not clear from the cup upon draining causing noise flags
to occur.
1
Using an applicator swab, skim off the visible precipitate floating at the top of the PHOSm cup
surface.
2
Drain the PHOSm cup.
• Select:
— Utils from the menu bar,
— 2 Maintenance,
— 4 Cup Maintenance,
— Phosphorus button,
— Drain.
The cup drains in preparation for maintenance.
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3
Clean the inside of the PHOSm cup with an applicator swab moistened with deionized water.
4
Select OK when the cup cleaning is complete. The cup primes five times with water.
5
Select Close to exit the Result pop-up window.
6
Select Cancel to exit the Cup Maintenance dialog box.
IMPORTANT The System does not autoprime in Maintenance mode. After completing a maintenance
procedure, or when a procedure is aborted, exit the Maintenance menu to resume autoprime. Return
the system to Standby.
Inspect the Cuvette Washer Probe
The following procedure is used to inspect the cuvette washer probe. If the cuvette wash station
probe is obstructed by debris (such as glass from a broken cuvette), the DxC may provide inaccurate
results. If any of these steps fail, contact Beckman Coulter Support Center or a local Beckman
Coulter representative to identify and resolve any suspected problems.
1
Remove the Cuvette Wash Station cover. Pull up on the two locking pins. Move the right side of
the cover forward. Carefully lift out the cover.
2
Loosen the two thumbscrews (1) on each side of the cuvette washer and lift off the upper section
of the cuvette wash assembly.
Figure 9.77
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3
Hold the wash station probes over a beaker or a container.
CAUTION
The Reaction Carousel continues to rotate during the Prime cycle.
4
Prime the wash lines one time.
• Select:
— Utils from the menu bar,
— 1 Prime,
— CC F2,
— Cuvette Wash.
• Type 1 in the Number of primes to repeat field.
• Select Start Prime.
5
Observe the wash probe spray pattern during the prime. There should be three distinct and
straight streams in a triangular pattern spraying from each probe.
NOTE If a pattern of distinct streams is not observed during prime, check for proper water pressure in
the hydropneumatic system. If the water pressure is adequate, check the probe tips for broken glass.
6
When the priming has stopped, turn the wash station to check the tips of the probes for
obstructions. Check for debris like glass from the cuvettes or resin beads, which can cause a
blockage of the probes. Manually remove any obstruction. You can use a small can of
compressed air to remove the blockage by blowing air through the probes from the probe top.
If you cannot remove the blockage, contact Beckman Coulter Support Center for instructions
on how to replace cuvette washer probes.
7
Place each of the first three wash probes into three 13 × 100 mm test tubes (one probe per test
tube). Be careful to keep the probes above the surface of the liquid.
8
Prime the wash lines one time.
• Select:
— CC F2,
— Cuvette wash.
9
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Type 1 in the Number of primes to repeat field.
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10 Select Start Prime.
At the end of the prime check for the following conditions:
• The amount of liquid that is delivered to the test tubes.
• The volume in tube 1 should be approximately equal to the volume in tube 2.
• The contents of tubes 1 and 2 should appear to have bubbles.
• The volumes in tubes 1 and 2 should be approximately 20% greater than the volume in
tube 3.
• The contents in tube 3 should appear clear.
NOTE Unlike running a test, precise volumes are not required for washing and rinsing.
11 Position the probes 1 through 3:
• Near the bottom of three 2.0 mL sample cups (one probe per cup)
OR
• Near the bottom of three small sample tubes (one probe per tube)
NOTE Do not push the probes against the bottom of the sample containers. This restricts the
vacuum.
12 Prime the wash lines one time.
• Select:
— CC F2,
— Cuvette wash.
13 Type 1 in the Number of primes to repeat field.
14 Select Start Prime.
Check the cups at the end of the prime cycle. Ensure that no liquid remains in the cups.
NOTE If liquid remains in the cups, an obstruction may still be present.
15 Replace the upper section of the cuvette wash assembly and tighten the screws finger-tight.
16 Orient the wiper square to the cuvette opening in the cuvette retaining ring.
17 Reinstall the Cuvette Wash Station cover.
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Wash All Cuvettes With System Wash
The following procedure describes the automated procedure to clean all the cuvettes on the
Reaction Carousel. This procedure should be performed as needed to maintain chemistry
performance. This routine takes approximately 20 minutes.
IMPORTANT System does not autoprime in Maintenance mode. After completing a maintenance procedure,
or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the system to
Standby.
1
Select:
• Utils from the menu bar,
•
2 Maintenance,
•
6 Wash All Cuvettes.
Follow all instructions on the screen.
2
Select Continue to perform the procedure.
You can exit this procedure at any time before it is completed.
• To exit, select:
— STOP on the instrument; wait for system to finish processing,
— OK to clear the pop-up message,
— Cancel to exit the procedure screen,
— Instr Cmd from the menu bar,
— 1 Home.
3
Select Close at the completion of this procedure to exit the Result pop-up window.
4
Exit Maintenance menu.
IMPORTANT To resume autoprime and return the system to Standby, you must exit the Maintenance
menu.
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Wash the CC Reagent Cuvettes with CCWA
CC Reagent Wash All Cuvettes is an automated procedure that cleans all the cuvettes on the Reaction
Carousel using a cartridge filled with cleaning solution. This procedure should be performed on
dirty cuvettes that require additional washing beyond the Washing All Cuvettes procedure. This
routine takes approximately 38 minutes.
IMPORTANT System does not autoprime in Maintenance mode. After completing a maintenance procedure,
or when a procedure is aborted, exit the Maintenance menu to resume autoprime and return the system
to Standby.
Materials Required:
• CCWA cartridge (PN 657133)
1
Load the CCWA cartridge on the system.
• Select:
— Rgts/Cal from the menu bar,
— An empty chem position to load,
— Load F1.
2
Select:
• Utils from the menu bar,
•
2 Maintenance,
•
9 CC Reagent Wash All Cuvettes.
OR
Type 9 in the Procedure No. field and press (Enter) .
Follow all instructions on the screen.
3
Select Continue to perform the procedure.
You can exit this procedure at any time before it is completed.
• To exit, select:
— STOP on the instrument; wait for system to finish processing,
— OK to clear message,
— Cancel to Exit the procedure screen,
— Instr Cmd from the menu bar,
— 1 Home.
4
9-110
Select Close at the completion of this procedure to exit the Result pop-up window.
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Maintenance
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5
Exit the Maintenance menu.
IMPORTANT To resume autoprime and return the system to Standby, exit the Maintenance menu.
Clean the Work Surfaces
Clean all exposed work surfaces and covers that may have contacted sera or other biological fluids.
1
Remove reaction carousel cover (1) and sample carousel cover (2).
Figure 9.78
2
Scrub the covers with a good grade of disinfectant soap and a soft brush.
3
Rinse the covers in deionized water. Dry thoroughly using lintless tissue.
4
Reinstall the covers.
5
Wipe all exposed surfaces on the system with a 10% bleach* solution (one part 5.25% sodium
hypochlorite (PN A32319), combined with nine parts deionized water). The surfaces include:
sample rack area covers, pull down cover, compartment doors, keyboard, table surfaces and
sides of the console.
* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).
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9
Maintenance
As-Needed/As-Required Maintenance
Wipe the touchscreen with 70% isopropanol, water, or any commercial computer screen
cleaner.
Decontaminate the Sample Racks
1
Prepare a 10% bleach* solution (one part 5.25% sodium hypochlorite (PN A32319), nine parts
deionized water). Use within 24 hrs.
2
Using a large container or sink, immerse all sample racks in the bleach solution.
3
Allow the sample racks to soak at room temperature in the 10% bleach solution for 15–20
minutes.
4
Remove the racks, rinse with deionized water or tap water, and allow to dry.
IMPORTANT Repeated decontamination of racks may result in rack label damage. If the label starts to
bubble or peel, remove and replace with a new label.
Decontaminate the Instrument
This procedure provides instructions for cleaning and decontaminating system tubing, waste
sumps, and reservoirs. Perform this procedure when microbial contamination is either evident or
suspected. This procedure should take about 1.5–2.0 hours.
CAUTION
All biohazard precautions should be observed when doing maintenance, service,
or troubleshooting on the system. This includes but may not be limited to wearing
gloves and eye shields, and washing hands after working on contaminated
portions of the system.
Materials Required:
• 10% bleach solution (one part 5.25% sodium hypochlorite (PN A32319), combined with nine
parts deionized water) - 8 Liters
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Maintenance
As-Needed/As-Required Maintenance
1
Shut down the hydropneumatic system as follows:
• Select Utils from the menu bar.
• Select 2 Maintenance.
• Select 5 Hydropneumatic Maintenance.
• Proceed to Step 2 only when the following message appears:
"The Hydropneumatic system has been shut down."
2
Open the lower, middle compartment door; release latch (1) on the hydropneumatics drawer
and pull out the hydropneumatic system.
Figure 9.79
1
A016466P.EPS
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Maintenance
As-Needed/As-Required Maintenance
3
Remove the Wash Concentrate bottle (1), the DI Water Reservoir canister (2), and the DI Water
canister (3) from the system. If necessary, use the spanner wrench tool to remove the canisters.
Refer to the UniCel DxC Synchron Clinical Systems Reference Manual, CHAPTER 4, Advanced
Maintenance and User Servicing, Cleaning Hydro Canisters, Waste Sumps, Reservoirs, and Float
Sensors, to remove the DI Water reservoir and DI Water canister.
Figure 9.80
2
1
3
A016489P.EPS
4
Empty the canisters. Then fill the canisters and the empty Wash Concentrate bottle with a 10%
bleach solution about two-thirds full.
5
Install both canisters with the 10% bleach solution back onto the system using the spanner
wrench tool, if necessary. Make sure the large O-ring is in place and both canisters fit tightly.
6
Install the Wash Concentrate bottle with the 10% bleach solution back onto system.
7
Restart the hydropneumatic system as follows:
• Select Close from the Hydropneumatic Shutdown screen.
• Select Exit F10 to exit the Maintenance screen.
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Maintenance
As-Needed/As-Required Maintenance
8
Prime the 10% bleach solution through the CC and MC subsystems as follows:
• Select Utils from the menu bar,
• Select Prime,
• Select the All CC Subsystems check box,
• Type 10 in the Number of primes to repeat field,
• Select MC F4,
• Select the following check boxes:
 All cup chemistries (ALBm, CREm, GLUCm, PHOSm, TPm, BUNm/UREAm)
 DI water
 Sample Delivery Subsystem
 EIC wash
• Select Start Prime. Allow all primes to complete.
9
Repeat Steps 1–8 three more times.
10 After the last prime is completed, allow the system to sit idle with 10% bleach solution for ten
minutes.
11 Remove both DI Water canisters and the Wash Concentrate bottle from the system. Use the
spanner wrench tool, if necessary. Empty out the bleach solution and rinse out the canisters
with DI water.
12 Install both canisters back onto the system using the spanner wrench tool, if necessary. Make
sure the large O-ring is in place and both canisters fit tightly.
13 Install the original Wash Concentrate bottle onto the system.
14 Refer to Step 7 and restart the hydropneumatic system.
15 Calibrate and run QC on all CC and MC chemistries.
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Maintenance
As-Needed/As-Required Maintenance
Replace the CTS Wick
This procedure applies to the UniCel DxC 600/800 and the UniCel DxC 600i Systems with the Closed
Tube Sampling (CTS), 1-Blade Thick Option. The wick is found within the Cap Piercer Assembly.
The Cap Piercer wick and blade are normally replaced every two months during scheduled
maintenance. However, if blood is not continuously wiped from the sample tube caps before they
are loaded onto the instrument, the CTS blade/wick area becomes dirty. This may cause a
contaminated condition. As a result, use this procedure to replace the wick as needed.
CAUTION
All biohazard precautions should be observed when doing maintenance,
service, or troubleshooting activities on the system. This includes but may not be
limited to wearing gloves and eye shields, and washing hands after working on
contaminated portions of the system.
Materials Required:
• 1 medium flat-edge screwdriver
• 1 medium Phillips screwdriver (for DxC 600i systems)
• 1 small tweezers
• 2 plastic trays (approximately 9 inches × 12 inches) (23.9 centimeters × 30.5 centimeters)
• Absorbant paper towel
• 1 bottle of Auto-Gloss
• 1 Wick Kit (PN A26924)
• Cotton-tip applicators (6 inches [15.2 centimeters] long, or greater)
• Disposable pipettes
• Personal protective gear such as rubber gloves and eye shields
• Scissors
System Preparation
The Cap Piercer Blade must be lowered before the Wick is replaced. Perform the following
procedure:
9-116
1
Select Utils from the menu bar.
2
Select 2 Maintenance.
3
Select 1 CTS Blade Replacement.
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Maintenance
As-Needed/As-Required Maintenance
4
Select Continue. Wait for the Maintenance pop-up confirmation window.
CAUTION
DO NOT select OK when the cover is removed. If you select OK the Cap Piercer
Carriage moves up and causes a pinch hazard
Remove the Cap Piercer Cover
The Cap Piercer Cover must be removed to get access to the Cap Piercer Assembly. Refer to
Figure 9.81 and perform the following procedure:
1
Lift the instrument cover.
2
Use a flat-edge screwdriver to fully loosen the two screws (1) from Cap Piercer Cover (2).
Figure 9.81
2
1
A007556P.EPS
3
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Lift and remove the Cap Piercer Cover and set it aside.
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9
Maintenance
As-Needed/As-Required Maintenance
Remove the Blade Assembly and Wick Clip Assembly
The Cap Piercer Assembly is now visible as shown in Figure 9.82. Remove the Blade Assembly and
Wick Clip Assembly as follows:
1
Refer to Figure 9.82. Use a flat-head screwdriver to loosen the two Blade Holder Screws (1) from
Blade Holder (2).
CAUTION
The points of the Blade (3) are very sharp and extend below the Wash
Tower (4). To prevent possible injury or exposure, avoid the bottom of the Wash
Tower.
Figure 9.82
1
2
4
3
A007557P.EPS
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Maintenance
As-Needed/As-Required Maintenance
2
Refer to Figure 9.83. Lift the Blade Assembly (1) straight up as shown.
NOTE The Blade Holder Assembly includes the Blade Holder and the Blade.
CAUTION
The points on the end of the Blade are very sharp and have been
exposed to potentially biohazardous fluids. To prevent possible injury or
exposure, avoid the Blade area.
Figure 9.83
1
A007558P.EPS
3
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Put the Blade Assembly onto a plastic tray. DO NOT touch the Blade.
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9
Maintenance
As-Needed/As-Required Maintenance
4
Remove the old Wick Clip Assembly (1) from Wash Tower (2) by lifting up on both sides of Wick
Clip as shown in Figure 9.84. Make sure that the old Wick is retained within the Wick Clip. If the
wick is NOT in the Wick Clip, the Wick should be found within the Wash Tower area. In this case,
use tweezers to remove the Wick. Put the old Wick and Wick Clip into a biohazard waste
container.
CAUTION
Observe all laboratory practices or procedures that pertain to handling of
infectious and pathogenic materials.
Figure 9.84
3
1
1
2
A007559P.EPS
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Maintenance
As-Needed/As-Required Maintenance
Clean the Blade
It is recommended to clean the Blade at or near the instrument. If required, use the tray to carry
blade/wick items to other locations. Clean the Blade as follows:
1
Refer to Figure 9.85. Rinse the Blade with hot water as shown.
CAUTION
The points on the end of the Blade are very sharp and have been
exposed to potentially biohazardous fluids. To prevent possible injury or
exposure, avoid the Blade area.
Figure 9.85
A007560P.EPS
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Maintenance
As-Needed/As-Required Maintenance
2
Refer to Figure 9.86. Wipe the Blade with a cotton-tip applicator as shown.
CAUTION
The points on the end of the Blade are very sharp and have been
exposed to potentially biohazardous fluids. To prevent possible injury or
exposure, avoid the Blade area.
Figure 9.86
A007561P.EPS
3
9-122
Put the Blade Assembly back on the same tray.
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Maintenance
As-Needed/As-Required Maintenance
Lubricate the New Wick
It is recommended to lubricate the Wick at or near the instrument. If required, use the tray to carry
blade/wick items to other locations. Refer to Figure 9.87 and perform the following procedure:
1
Remove a new Wick Clip Assembly (includes wick clip and wick) from package.
2
Put a piece of paper towel onto another tray. Put the new Wick Clip Assembly onto the paper
towel.
3
Use a pipette and apply 10 to 12 drops of Auto-Gloss Lubricant (1) directly onto the Wick (2), or
apply the drops until the Wick becomes saturated.
CAUTION
Be careful when handling Auto-Gloss lubricant. This lubricant is extremely
slippery and difficult to clean from the floor.
Figure 9.87
1
2
A007562P.EPS
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Maintenance
As-Needed/As-Required Maintenance
Install the Wick Clip Assembly and Blade Assembly
1
Install Wick Clip Assembly (1) onto Wash Tower (2). Make sure both ends of the Wick Clip are
secured. Refer to Figure 9.84.
2
Carefully pick up the Blade Assembly and orient end points of Blade with Slots (3) on Wick Clip.
Slowly push the Blade Assembly straight down so that the Blade goes through the Wick,
through the Wash Tower, and through the alignment slot at the bottom. Refer to Figure 9.84.
CAUTION
The points on the end of the Blade are very sharp and have been
exposed to potentially biohazardous fluids. To prevent possible injury or
exposure, avoid the Blade area.
3
Lift up the Blade Assembly again as shown in Figure 9.83. Put the Blade Assembly back on the
plastic tray.
4
Remove the Wick Clip Assembly again as shown in Figure 9.84. Examine the bottom of Wick area
for any loose fibers. Remove any loose fibers with scissors.
NOTE Loose fibers clog the drain.
9-124
5
Repeat Steps 1 and 2 above.
6
Align Blade Holder (2) to screw holes. Install and tighten the two Blade Holder Screws (1) with
a screwdriver. Refer to Figure 9.82.
7
Install the Cap Piercer Cover (2). Tighten the two cover Screws (1) with a screwdriver. Refer to
Figure 9.81.
8
After the Cap Piercer Cover is installed, select Cancel on the screen to retain the blade count
since the Blade was not replaced. If OK is selected, the system resets the blade count to zero.
9
Select Exit F10 to exit the Maintenance screen.
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Maintenance
As-Needed/As-Required Maintenance
10 Place four sample tubes that are capped and empty into an appropriate sample rack.
• If the system is a DxC 600/800, go to Step 11.
• If the system is a DxC 600i, go to Step 12.
11 For a DxC 600/800 system, place the rack into the autoloader with no sample programming.
Press the RUN button to pierce the tube caps. Inspect the bottom of each cap to confirm that the
cap was pierced.
12 For a DxC 600i system, loosen the two Phillips screws on the cover of the DxC Load Area and
remove the cover. Place the rack into the DxC Load Area with no sample programming.
NOTE Do not load the rack into the DxC 600i Load Area.
Loosen the screw and open the cover of the DxC Load Area RUN button (located to the right of
the DxC 600i Load Area). Press the DxC Load Area RUN button to pierce the tube caps. Inspect
the bottom of each cap to confirm that the cap was pierced. Close the DxC Load Area RUN button
cover and tighten the screw. Replace the DxC Load Area cover.
Replace ISE Drain Pump Tube
The DxC system must be in Standby.
Materials Required:
• ISE Drain Pump Tube (PN A43830)
1
Select:
• Utils from the menu bar
• 2 Maintenance
• 5 Hydropneumatic Maintenance
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9
Maintenance
As-Needed/As-Required Maintenance
2
Open the left door on the DxC. The ISE drain pump is located on the inside left wall.
CAUTION
BIOHAZARDOUS MATERIALS HAZARD. Observe all biohazard precautions when
you perform maintenance, service, or troubleshoot the system. This includes, but
may not be limited to, wearing gloves and eye shields and washing hands after
working on contaminated portions of the system.
MOVING PARTS HAZARD. Do not place hands near any moving parts while the
system is operating.
3
Refer to Figure 9.88.
• Lower the clear plastic cover (1).
• Disconnect both pump tube fittings (2 and 3), and move the tube out of both pinch clamps
(4 and 5).
• Manually rotate the pump roller mechanism (6) approiximately half a turn while removing
the tube. Use caution as the tube may contain residual fluid.
Figure 9.88 ISE Drain Pump
1. Plastic Cover
2. Pump Tube Fitting
3. Pump Tube Fitting
4
9-126
4. Pinch Clamp
5. Pinch Clamp
6. Pump Roller Mechanism
Discard the used tube in a bio-hazardous waste container.
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Maintenance
As-Needed/As-Required Maintenance
5
Install a new ISE drain pump tube:
• Connect the tube to the tube fitting and route it through the pinch clamp on one side of the
pump.
• Rotate the pump roller mechanism approiximately half a turn while feeding the tube under
the pump rollers.
• Route the tube through the second pinch clamp and attach it to the tube fitting on the other
side of the pump.
• Close the plastic cover.
6
Verify that the tube is properly positioned under the pump rollers and is not twisted.
7
Select Close to exit the maintenance procedure and return the system to Standby.
8
Select Exit F10
9
Select 1 Prime.
10 Select:
• All Hydropneumatic Subsystem from the Prime dialog box.
• Type 5 in the Number of primes to repeat field.
• Start Prime.
11 As the ISE primes, check for leaks or bubbles from the tube or fittings, ISE waste draining, and
the tube seated properly.
If you see a problem, select Stop Prime. Check the fitting connections or replace a damaged tube,
starting again at Step 1 above.
12 Prime the ISE 20 times and watch for bubbles or leaks.
13 Select Exit F10 to return to the Utilities screen.
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Maintenance
As-Needed/As-Required Maintenance
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CHAPTER 10
System Status and Commands
Overview
The System Status, Instrument Commands, and Help features provide real-time summaries and
control of essential instrument components.
System Status
Introduction
Status Summary provides a high level summary of the status of the system temperatures, power,
hydropneumatic, and ICS/Smart Module components on a real-time basis in that all parameters are
updated every eight seconds. Cycle count information and cuvette cleanliness data are also
provided.
IMPORTANT The Status icon on the menu bar is highlighted whenever a warning or error condition exists
on the Status Monitor screen. A highlighted status icon should be investigated by the operator, as further
action may be necessary to correct the warning or error condition.
Show Status Summary
1
Select Status from the menu bar.
2
A summary of the monitored areas appears.
Possible Status Messages
The following table lists the possible status messages and their meanings. If parameters are outside
the limits, only the most severe situation is indicated.
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10-1
System Status and Commands
Status-Cycle Count
Table 10.1 Status Messages
Status
Description
Error
Parameters which exceed allowable limits are called errors. If any of the parameters
in a monitored area exceed the allowable limit, Error appears with a red highlight.
Warning
Parameters which are out of recommended limits but still within allowable limits are
called Warnings. If any of the parameters in a monitored area are out of
recommended limits but still within allowable limits and there are no other
parameters that are in a error condition, Warning is shown with a yellow highlight.
Not all parameters have both a recommended range and an allowable range.
OK
If all of the parameters are within limits, OK is shown.
What to Do If There is an Error
If any of the monitored areas show a Warning or Error status, select the tab for that area. This shows
each parameter for the monitored area and indicates the specific parameter that is out of limits.
Return to Status Summary
When viewing the detailed status information, it is possible to return to the Status Summary by
selecting the Summary tab.
Status-Cycle Count
Introduction
The Status-Cycle Count provides an approximation of an instrument's usage. This information can
be useful for estimating maintenance frequencies or anticipating component failure. Cycle counts
may be periodically collected by Beckman Coulter using the instrument modem.
Show Cycle Count
10-2
1
Select Status from the menu bar.
2
Select the Count tab. A summary of the monitored areas appears.
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System Status and Commands
Temperatures
Cycle Count Description
Table 10.2 Counters
Counter
Description
Modular Chem
Each result for each cup is counted separately. Even if ORDAC is triggered, the
counter only increments for the one result.
ISE
A count of the number of samples run through the ISE module. Whether it is a
single chemistry per sample or a sample running all five chemistries, the ISE cycle
count increments only one time per sample processed through the ISE module.
Cartridge Chem
Each cartridge chemistry reagent dispensed is counted.
Blade Count
• This is the number of caps pierced by the blade(s).
• For 1-Blade CTS, the system sets this counter to zero when the blade is
replaced. To replace the blade for 1-Blade CTS, refer to CHAPTER 9,
Maintenance.
CTS Count
The total number of caps pierced by the Cap Piercer Module.
Sample Count
The total number of sample containers that have been scanned by a sample ID
bar code reader.
Temperatures
Introduction
The actual temperature of each of the various components is shown along with:
• the valid range.
• an indication of when a parameter is out of limits.
A yellow highlight indicates a warning condition and a red highlight indicates an error condition.
IMPORTANT While the system is in the Stopped state, temperatures will not be accurate. If the system boots
directly into the Stopped state, no temperatures are shown for the systems that caused the Stop state. If
the system goes to Stopped from Standby or Running, the temperatures shown reflect the previous state
and will NOT be updated while the system is Stopped.
Show Temperature Status
Follow the steps below to monitor instrument components (for example, reaction carousel, cups,
cuvette wash).
1
A13914AF
Select Status from the menu bar.
10-3
10
System Status and Commands
Power Subsystems
2
Select the Temp tab. A summary of the monitored areas appears.
Power Subsystems
Introduction
Status for the Power Subsystem shows:
• the actual voltage for each power distribution bus with the valid range.
• the status of the power supplies, peltiers and fans.
• an indication of when a parameter is out of limits.
A yellow highlight indicates a warning condition. A red highlight indicates an error condition.
Also shown is the status of the eight power supplies - OK, Warning, or Error with the same highlight
colors.
Show the Power Subsystem Status
1
Select Status from the menu bar.
2
Select the Power tab. A summary of the monitored areas appears.
Hydropneumatics Subsystem
Introduction
Status for the Hydropneumatics Subsystem shows the status for all of the reservoirs, canisters, and
sumps. A yellow highlight indicates a warning condition and a red highlight indicates an error
condition.
The following parameters are shown:
• external DI water system status, if enabled.
• status of the various hydro float switches.
• DI water resistivity measured on the instrument and its valid range.
• actual air and vacuum pressures and their valid ranges.
The same color highlights apply.
10-4
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System Status and Commands
ICS/Smart Modules
Show the Hydropneumatics Subsystem Status
1
Select Status from the menu bar.
2
Select the Hydro tab. A summary, by component name, of the monitored areas appears.
What to Do If a Parameter is Out of Limits
The range for air and vacuum levels are only valid when the system is in Standby and the
hydropneumatics are on. The hydropneumatics are automatically turned off after the system has
been in Standby for more than 15 minutes. While the hydro is off, all pressure and vacuum readings
show zero and a status of OK. To turn the hydro back on, either select a prime or press the RUN
button. Values fluctuate while the system is running.
For adjustment of the air and vacuum pressures, refer to the UniCel DxC Synchron Clinical Systems
Reference Manual. If the Waste B exit sump shows Paused, it has been stopped either automatically
by the system when the Waste B container is full, or by operator request. For additional information,
refer to Pause/Resume Waste B in this chapter.
ICS/Smart Modules
Introduction
ICS/Smart Module status monitors the power to the Smart Modules and the ability to communicate
to and from the Smart Module. Should the Smart Module lose power or the ability to send or receive
messages, an error appears.
Show the ICS/Smart Module Status
Follow the steps below to view the status of instrument components (for example, Reagent Probe,
cup modules). A yellow highlight indicates a warning condition and a red highlight indicates an error
condition.
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1
Select Status from the menu bar.
2
Select the SmrtMdl tab. A summary of the monitored areas appears.
10-5
10
System Status and Commands
Cuvette Water Blank Status
Cuvette Water Blank Status
Introduction
As a maintenance and troubleshooting aid, the Cuvette Status feature shows the absorbance values
for all 125 cuvettes at each of the 11 wavelengths available on the system (10 for the Photometer and
1 for the LPIA Module). The system derives the data from absorbance values obtained during
automatic water blank tests, which are part of cuvette washing.
From the Status Summary screen, a summary of the cuvette status appears under the Cuvettes Out
of Limit option. None indicates all cuvettes are clean. One or more dirty and a red highlight indicates
that at least one cuvette has failed the water blank test. Additional information is available under
Show the Cuvette Water Blank Status.
The current values are kept after the system goes to Standby but are lost when the system is reset
or powered off. When absorbance values are lost, the absorbance value will be zero until a water
blank test is run.
Show the Cuvette Water Blank Status
1
Select Status from the menu bar. From the Summary tab, under Cuvettes out of limit either None
or 1 or more dirty appears.
2
Select the CuvStat tab.
3
Use the scroll bar to view the various cuvettes.
If any of the absorbances are out of limit, the cuvette number is highlighted in red, indicating the
cuvette has been marked as dirty and are not used for analysis.
The right-most column is the Failed Count (Fcnt). It keeps track of the number of consecutive times
a cuvette has failed the water blank.
What to Do if a Cuvette is Dirty
A cuvette that is marked as dirty is not used for sample analysis but continues to be washed,
attempting to get it clean. If a cuvette repeatedly fails the water blank test, refer to CHAPTER 9,
Maintenance, As-Needed/As-Required Maintenance.
NOTE If only 940 nm wavelength cuvettes are dirty, the problem is only associated with the LPIA Module. You
can still continue to run chemistries that use the Photometer.
10-6
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System Status and Commands
CTS Tracking
CTS Tracking
Introduction
The CTS Tracking feature is used with DxC instruments that have the 1-Blade CTS option. It makes
sure that a sample tube is only pierced one time. This feature operates when up to four DxC
instruments are connected in a network.
NOTE If notified that CTS Tracking is lost, remove the cap of a sample tube before moving it to another
instrument.
Do Not Clear the Sample ID Manually
Before you run a sample whose cap has been pierced, be sure that its sample ID has not been cleared.
• If you clear a sample ID at the Host the sample ID is NOT cleared in the CTS Tracking database.
• If you were to manually clear the sample ID for a tube, you would also clear the sample ID in the
CTS Tracking database. The instrument would think it has a new tube and would pierce its cap
again.
For each DxC instrument in the network, CTS Tracking status shows its:
• Serial number
• Last update (day, date and time)
• Instrument status
Show the CTS Tracking Status
1
Select Status from the menu bar.
2
Select the CTS tab. The CTS Tracking status of the instruments in the network appears.
What to do if a Parameter is Out of Limits
If a status is other than OK, examine the network for:
• A loose connector
• A break in the network cable or
• A console error
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10-7
10
System Status and Commands
Instrument Commands
Instrument Commands
Instrument commands are high level system commands that are used to control the instrument and
printer.
Commands
Select Instr Cmd from the menu bar.
The following commands are available:
• Home – moves all mechanical assemblies to a known position.
• Pause – stops additional tests from starting; any tests with reagent already added will complete.
• Stop Print – prevents print requests in the queue from being sent to the printer.
• Shutdown – reboots the system (warm boot) or safely powers off the system.
• Pause Waste B – allows the external Waste B container to be emptied while the system is
running.
• Resume Waste B – resumes the dumping of Waste B to the external container.
• Enable/Disable Modules – enables or disables modules.
• Unload all racks – unloads all racks.
Home
Introduction
Home is used to move mechanical assemblies to a known "home" position and primes the system.
Why Use Home
Home is useful in the following situations:
• to attempt recovery from a motion error.
• to return the system or one component of the instrument from a Stopped state to Standby.
10-8
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System Status and Commands
Pause
Home
IMPORTANT If the STOP button is pressed immediately after selecting Home:
•
Wait at least 10 seconds.
•
Press the STOP button again.
This makes sure that the system correctly reaches the Stopped state.
NOTE If one side of the instrument (MC or CC) is Stopped and the other side is running, the Home command
operates on the side that is Stopped. The other side of the instrument continues to run.
1
Select Instr Cmd from the menu bar.
2
Select 1 Home.
The instrument status changes to Homing. If the home completes successfully, the instrument
will be in Standby. Should an error occur, the status will be Stopped and the appropriate error
message appears.
Pause
Introduction
Pause provides a way to prevent new tests from being started without wasting sample or reagent as
pressing STOP does. Those tests that already had reagent pipetted will run to completion, but no
new tests will be scheduled. This feature can pause the MC side, the CC side or both the MC and CC
sides of the instrument. The system will transition the paused side(s) of the instrument from
Running to Pausing and eventually will reach Standby. To reach Standby status as soon as possible,
cuvette washing stops as soon as the last result is available. Cuvettes may be left dirty.
IMPORTANT Do not request a Pause and leave the system sitting for a long period of time without washing
the cuvettes. If cuvettes are left sitting with reactant, evaporation will occur, leaving encrustation on the
sides of the cuvette that may require washing by hand.
Dirty cuvettes are washed automatically when the system status is Running or cuvettes can be washed
when the Maintenance option Wash All Cuvettes is selected.
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10-9
10
System Status and Commands
Pause
When to Use Pause
Use Pause when the system must be interrupted but there is not an immediate need to stop the
samples in process. Correct uses of Pause include:
• When maintenance is needed but the system is already running.
• When a rack needs to be removed from the sample carousel but is not needed immediately or
to avoid wasting reagent.
When NOT to Use Pause
Do not use Pause when there is danger involved or when the situation can be handled with another
function.
Table 10.3 Alternatives Instead of Pause for Some Situations
Situation...
Instead of Pause...
Imminent danger to a person or the
instrument.
Press the STOP button or turn off power.
Reagent needs to be loaded while the
system is running.
Perform a reagent load as usual and the system automatically
interrupts reagent additions to allow the reagent load to continue.
Upon completion of the reagent load, the system will resume
running samples.
Sample on the sample carousel is
needed immediately.
From the Main screen select the rack with the sample needed
and select Unload F2. Note that any tests that have been started
for the samples in the rack that have not yet had sample added
will be aborted. The rack, however, will be available within
approximately 40 seconds.
Pause
1
Select Instr Cmd from the menu bar.
2
Select 2 Pause.
3
To pause the related part of the instrument, from the Pause dialog box, select:
•
1 MC Only,
•
2 CC Only
OR
•
3 Both MC and CC.
OR
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System Status and Commands
Stop Print
Type 1, 2 or 3 in the Option Number field and press (Enter) .
NOTE Press RUN to continue the run after a Pause.
IMPORTANT Do not request a Pause and leave the system sitting for a long period of time without washing
the cuvettes. If cuvettes are left sitting with reactant, evaporation will occur, leaving encrustation on the
sides of the cuvette that may require washing by hand.
Stop Print
Introduction
Stop Print will stop print requests that are still in the print queue and prevent them from being sent
to the printer. This feature is useful in stopping print requests composed of many pages, such as the
entire Event Log, some QC reports, or preventing multiple print requests.
How Stop Print Works
Print requests are stored in the printer queue in the console. As portions of these requests are ready
to print, they are sent to the printer buffer and ultimately printed.
Stop Print deletes all of the print requests in the queue. Any portions of the print request already in
the printer buffer, which could be several pages, will be printed.
Stop Print
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1
Select Instr Cmd from the menu bar.
2
Select 3 Stop Print.
10-11
10
System Status and Commands
Shutdown
Shutdown
Introduction
Shutdown is used to place the system into a state where it is safe to reset or turn power off. System
files are closed to prevent data corruption.
IMPORTANT When you perform a shutdown, it is very important to read and follow the instructions on the
screens. Do not turn the console off until "Shutdown: It is now safe to reboot your computer" appears on
the monitor. If power is turned off before this, there is a potential for data corruption.
Additional Information
For additional information about preparing the system to remain in a powered-off condition for an
extended period, refer to the Extended Shutdown procedure in the UniCel DxC Synchron Clinical
Systems Reference Manual.
Shutdown
1
Verify that the system is in Standby or Stopped.
2
Select Instr Cmd from the menu bar.
3
Select 4 Shutdown.
4
Select OK. The Shutdown in Progress screen appears with the message "Please wait for further
instructions. DO NOT TURN THE POWER OFF."
The system status goes to Shutdown.
5
From the Select Reboot or Shutdown dialog box, select the appropriate option:
• Reboot to return the system to an operational state. The system automatically reboots and
returns to the Main screen.
OR
• Shutdown to prepare the system to have the power turned off. A counter appears while the
system shuts down. When "Shutdown: It is now safe to reboot your computer" appears in the
top, left corner of the screen:
— Turn off the console power: press and hold the power button until the light goes out.
— Turn the instrument main power switch (1) behind the far right door to the OFF (O)
position. Refer to Figure 10.1.
10-12
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System Status and Commands
Shutdown
6
To restore power, refer to System Power On/Boot.
ON/OFF Switch
The circuit breaker/power ON/OFF (O/|) switch is located behind the front right-hand door of the
instrument.
Figure 10.1 ON/OFF (O/|) Switch
1
A016487P.EPS
1. Main Power ON/OFF (O/|)Switch
Line Converter Device
All power to the instrument is passed through the line converter device located in the lower right
compartment of the instrument. The line converter serves as a conditioner to limit the effect of line
voltage changes that could damage the sensitive electronic components of the system.
DC Output Power Supplies
Power is routed to redundant DC output power supplies which provide 24V or 36V power for
distribution throughout the system. By using redundant power supplies, not all are used at any one
particular time. Should one fail, the operator is alerted, but may continue operation unaffected.
Uninterruptible Power Supply (UPS)
The computer console requires an additional power source. The UPS plugs into a standard 110-120V
AC, 50/60 Hz power source. The UPS in turn supplies power to the computer console and the
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10-13
10
System Status and Commands
System Power On/Boot
monitor as well as providing a short-term battery backup in case of a power failure. The printer
plugs directly into its own standard (110-120V AC, 50/60 Hz) power source.
Power Cord Connections
Power is connected to the instrument through the intermediate three-wire power cord with special
twist lock connectors. One end of the connector plugs directly into the back panel receptacle of the
instrument while the other end plugs into the appropriate laboratory outlet.
System Power On/Boot
Introduction
The first software routine executed from a power-on or reset condition is the boot-up. Boot software
places the instrument into a functional state by performing system initialization, running boot
diagnostics, and loading the operating system.
Power Up Sequence
The following procedure describes the power-up sequence often referred to as a hard (or cold) boot.
Use this procedure after an instrument shutdown.
1
If the monitor is off, turn it on.
2
If the printer is off, turn it on.
3
Press the power button to turn on the console. If you have an external UPS, make sure that it is
turned on.
4
Turn the instrument main power switch to the ON (|) position. Refer to Figure 10.1.
Full Boot
When power has been restored or a reboot has occurred, the boot-up routine will begin
automatically. The monitor will show the Main screen. Select the Status icon to display the boot-up
information, at the bottom of the Status Summary screen.
• Hardware Diagnostics are performed first. OK appears upon completion, unless an error
condition is found.
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System Status and Commands
Pause/Resume Waste B
• Following successful hardware diagnostics, the ICC Boot will begin. A bar graph appears
indicating how far the ICC Boot has progressed.
• The MSMC Boot follows the ICC Boot. Again, a bar graph shows progress.
• The next area booted is the Smart Module Boot; a bar graph shows progress.
• The final step includes homing of all mechanisms, removal of any racks on the sample carousel,
and priming of the system. During the boot sequence, the instrument status is Startup. Upon
completion of the boot sequence, the instrument status shown on the console changes to
Standby.
After Boot-up
If a temperature error occurs immediately after system boot-up, no action is required because the
system temperature has not yet equilibrated. During temperature equilibration, which takes
approximately 30 minutes, temperature errors should be ignored.
The Glucose sensor may drift over the first 24 to 48 hours. Verify control recovery at 4 hours and
recalibrate if necessary. More frequent calibration may be required during the first 24 to 48 hours
following installation.
Reset
For instructions on how to perform a reset (or reboot) refer to Shutdown, in this chapter.
Pause/Resume Waste B
Introduction
The Waste B option allows for some of the waste to be collected in an external bottle instead of going
immediately down the drain. It is only necessary to use the Pause Waste B option if your system is
configured with a Waste B collection bottle. Pause Waste B prevents the instrument from filling the
collection bottle to allow for exchange of bottles. Resume Waste B is used to return to normal
operation after Waste B removal was paused or to recover from certain flood conditions.
IMPORTANT If the Waste B option is paused and the Waste B exit sump is full, the system will not run until
the Resume Waste B option is selected.
Pause Waste B
1
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Select Instr Cmd from the menu bar.
10-15
10
System Status and Commands
Enable/Disable Modules
2
Select 5 Pause Waste B.
Waste B removal will be paused until Resume Waste B is selected. The Instrument Commands screen
remains so that Resume may be selected. Pause Waste B will be gray, to indicate it is already paused.
Resume Waste B
1
Select Instr Cmd from the menu bar.
2
Select 6 Resume Waste B.
The system will return to its normal operational state. The Instrument Commands screen closes
automatically.
Enable/Disable Modules
Introduction
Enable/Disable allows the user to Enable and Disable an individual subsystem module, the MC side,
or the CC side. This function allows some subsystems to operate while others are disabled due to
error conditions.
Additional Information
The user can manually enable or disable the following items:
• One or more individual MC modules (cups and ISE)
• All of the MC side
• Photometer
• LPIA Module
• All of the CC side
• Lower Reagent Carousel (1–30)
Notes:
 The optional LPIA Module must be installed to be able to enable or disable the LPIA Module.
 A module should be enabled or disabled only when the system is in Standby or is Stopped.
 To complete the enable for 1-Blade CTS, or LPIA, the operator must stop and home the DxC.
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System Status and Commands
Enable/Disable Modules
 All programming for Disabled modules is aborted. Modules or subsystems in the Disable mode
will not run, prime, or perform desired maintenance/diagnostic procedures.
When the MC module is enabled, the related reagent is primed 4 times. When the CC subsystem is
enabled, the system runs startup primes.
With an error, for example Reagent too full, the DxC automatically disables a module or subsystem.
The Rgts/Cal status screen changes to Disable (refer to CHAPTER 4, Reagent Load/Calibration for
additional information).
IMPORTANT When an MC Module or CC subsystem is enabled, the calibration status will not be lost. Check
the calibration status screen prior to running the system.
IMPORTANT When a module is Enabled, the system will go to Standby as it prepares for a prime. The system
will not accept work requests at this time. Reagents should be reloaded when a module is Enabled to
ensure that fresh reagents are used for subsequent testing.
Disable Modules
1
Select Instr Cmd from the menu bar.
2
Select 7 Enable/Disable Modules.
3
Select the desired module button to disable.
4
Select OK to Disable the desired modules.
5
Select OK to confirm Modules shown in the message box.
OR
Select Cancel to exit without saving changes.
Enable Modules
IMPORTANT After enabling a chemistry or a module, run controls to verify proper operation.
If a reagent is loaded while the module is disabled, prime the module eight times after the module has
been enabled.
Starting from a Stopped state, a module is not enabled until the system is homed and goes to Standby.
1
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Select Instr Cmd from the menu bar.
10-17
10
System Status and Commands
Unload All
2
Select 7 Enable/Disable Modules.
3
Select the box of the desired module with a Disabled status to enable a module (remove blue
indicator bar).
4
Select OK to enable the desired modules.
5
After Enable is requested, there is an eight-second delay before the system starts to prime.
NOTE Do not press RUN during this eight-second delay. Samples would not be run (NOT ACCEPTED
error) because the system is priming.
Unload All
Introduction
Unload All is used when the instrument is in Standby. It removes all the sample racks, from the
sample carousel, to the offload track. It can be used:
• When access to a sample is required, or
• After a system error, if a rack is shown on the Main screen, but it is not physically on the
carousel.
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System Status and Commands
Unload All
Unload All Racks
1
Select Instr Cmd from the menu bar.
2
Select 8 Unload All Racks.
OR
Type 8 in the Command Number field and press (Enter) .
3
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All racks on the sample carousel are removed and the Instrument Command window closes. An
empty sample carousel is shown on the Main screen.
10-19
10
System Status and Commands
Unload All
10-20
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CHAPTER 11
Utilities
Overview
The Utilities option provides the software tools to prime hardware subsystems and to prepare them
for proper system readiness. Utilities can also be used to program the instrument for maintenance,
to perform diagnostics and alignments, to view the Event Log, to back up and restore data, and to
track reagent metering.
Prime
Introduction
The Prime feature of the Utilities menu permits the user to manually request a prime. An entire
subsystem can be primed. A prime can also be requested on an individual component (refer to the
tables below). This feature is only available when the system status is in Standby.
Table 11.1 A Prime for the CC Subsystems
CC Subsystems
Function
Reagent Delivery Subsystem
Washes the reagent probes and mixer, primes the reagent
syringe.
Sample Delivery Subsystem
Washes the CC sample probe and mixer, primes the sample
syringe.
Cuvette Wash Station
Primes cuvette wash Probes 1 and 2 with wash and Probe 3
with water.
Table 11.2 A Prime for the Hydropneumatics Subsystem
Hydropneumatics Subsystem
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Function
Fill canisters and reservoirs
Fills water, wash, and diluted wash.
CC Drain waste sump
Drains waste sump and exit sump.
CC Drain Waste B sump
Drains Waste B sump and exit sump.
Drain gravity drain sump
Drains the gravity sump.
11-1
Utilities
Prime
Table 11.3 A Prime for the Cups of the MC Subsystems
MC Subsystems
Function
Cups
ALBm (DxC 800 only)
Primes Albumin Reagent and/or water.
CREm (DxC 800 only)
Primes Creatinine Reagent and/or water.
GLUCm (DxC 600 and DxC 800)
Primes Glucose Reagent and/or water.
PHOSm (DxC 800 only)
Primes Phosphorus Reagent and/or water.
TPm (DxC 800 only)
Primes Total Protein Reagent and/or water.
BUNm/UREAm (DxC 800 only)
Primes BUN/UREA Reagent and/or water.
Table 11.4 A Prime for Other Components of the MC Subsystems
MC Subsystems
ISE Module (all)
Function
Primes all reagents used by the ISE module.
Electrolyte Buffer
Primes Electrolyte Buffer Reagent.
Electrolyte Reference
Primes Electrolyte Reference Reagent.
EIC Wash
Primes DI water to the EIC.
ISE CO2 Alkaline Buffer
Primes the CO2 electrodes with Alkaline Buffer Reagent.
Reference and Acid
Primes both Electrolyte Reference and CO2 Acid Reagent.
Sample Delivery Subsystem
Washes the MC sample probe with wash, primes the sample
syringe.
Table 11.5 A Prime for CTS Auto-Gloss and Blade Wash
CTS Auto-Gloss and CTS blade wash
Primes the blade wick. One prime supplies the same quantity
of lubricant as supplied with each cap pierce.
Accessing Prime
The Prime screen allows selection of a prime for an entire subsystem or access to the subsystem
screens to prime individual system components. Follow the steps below to access Prime.
1
Select Utils from the menu bar.
2
Select 1 Prime.
OR
Type 1 in the Option Number field and press (Enter) .
11-2
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Utilities
Prime
Stopping a Prime
When a Prime has started, you can stop the Prime before the selected number of replicates has
completed.
From any of the prime screens, select Stop Prime.
The replicate that is currently processing will complete and any remaining primes will be canceled.
Priming All Subsystems
If the entire group of subsystems, such as all Cartridge Chemistry (CC) subsystems, needs to be
primed, it is easiest to simply select the group of subsystems for prime instead of having to select
each individual subsystem. Follow the steps below to prime a group of subsystems.
1
Select Utils from the menu bar.
2
Select 1 Prime.
OR
Type 1 in the Option Number field and press (Enter) .
3
Select one or a combination of the following check boxes:
 All CC Subsystems
 All Hydropneumatic Subsystems
 All MC Subsystems
 Prime DxC
 CTS Auto-Gloss (CTS System only)
 CTS Blade Wash (CTS System only).
A13914AF
4
Type the desired number of primes (1–99) in the Number of primes to repeat field. This does not
apply for Hydro primes.
5
Select Start Prime. The system status changes to Priming.
6
Upon completion of the requested prime, the number of primes remaining will be blank and the
system status returns to Standby.
11-3
11
Utilities
Prime
Priming CC Subsystems
The CC Subsystem option allows independent priming of CC Reagent Delivery Subsystem, CC
Sample Delivery Subsystem and Cuvette Wash.
CAUTION
If any two of the CC Subsystem items are selected, all three will prime
automatically. Check to make certain that all three areas are ready to be primed
if any two are selected.
1
Select:
• Utils from the menu bar,
• 1 Prime,
OR
Type 1 in the Option Number field.
• CC F2.
2
Select one or a combination of the following check boxes:
 Reagent Delivery Subsystem
 Sample Delivery Subsystem
 Cuvette Wash.
11-4
3
Type the desired number of primes (1–99) in the Number of primes to repeat field.
4
Select Start Prime. The system status changes to Priming and the number of primes remaining
are shown.
5
Upon completion of the requested prime, the number of primes remaining will be blank and the
system status returns to Standby.
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Utilities
Prime
Priming Hydropneumatic Subsystems
The Hydropneumatics Subsystem allows independent priming of each of its components. Follow
the steps below to prime any combination of the components.
1
Select:
• Utils from the menu bar,
• 1 Prime,
OR
Type 1 in the Option Number field.
• Hydro F3.
2
Select any or all of the hydropneumatic subsystems.
3
Select Start Prime. Although the instrument status remains in Standby, the hydro prime will
begin.
Priming MC Subsystems
MC Subsystem Prime allows the priming of the cup modules, the ISE flow cell and EIC, and the
Sample Delivery Subsystem.
• If a cup selection is made and neither reagent or DI water is specified, only DI water will be
primed into the cup.
• If both reagent and DI water are selected, both will be primed and the cup(s) will be left full of
DI water.
• Whenever Acid is primed, Reference must also be primed to prevent acid shocking the
electrodes. Therefore there is no Acid-only option.
• Only one ISE selection can be made at a time. However the ISE All option can be used to select
the entire list.
1
Select:
• Utils from the menu bar,
• 1 Prime,
OR
Type 1 in the Option Number field.
• MC F4.
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11-5
11
Utilities
Maintenance
2
Select the desired cup(s) and specify Reagent and/or DI water.
AND/OR
Select a single ISE option by choosing a check box.
AND/OR
Select the Sample Delivery Subsystem check box.
3
Type the desired number of primes (1–99) in the Number of primes to repeat field.
4
Select Start Prime. The system status changes to Priming and the number of primes remaining
appears.
5
Upon completion of the requested prime, the number of primes remaining will be blank and the
system status returns to Standby.
Maintenance
Maintenance is routine instrument cleaning and replacement of parts as they become worn. Proper
maintenance is essential for optimal instrument performance.
Additional Information
Refer to the CHAPTER 9, Maintenance in this manual for maintenance instructions.
Event Log
Introduction
The Event Log is a record of events and errors that are logged (for example, CAU: DI Water Canister
Level Low. Message ID 0x01FA000E.). This logged information can be used as a troubleshooting tool
if a problem is encountered while operating the instrument.
The entire Event Log can be viewed, printed, or copied to disk. It is possible to select only a portion
of the Event Log to work with by specifying classes and/or a date and time range.
11-6
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Utilities
Event Log
Event Log Classes
Table 11.6 Event Log Classes
Class Number
Event Log
# of entries
1
Chemistry Errors
10,000
2
Motion Errors
10,000
3
Status Monitor Errors
10,000
4
Other Instrument Errors
10,000
5
Instrument Events
120,000
6
LIS Comm. Errors
180,000
7
Other Console Errors
10,000
8
Input Device Events
15,000
9
Other Console Events
10,000
10
Sample Processing Events
60,000
11
Deleted Results
10,000
Event Information
Table 11.7 Information in the Event Log
Event information
Definition
Number
Sequential number identifying the "order", with number one representing
the most recent entry.
Class
Number corresponding to the 1-10 event classes listed on the Event Log
main screen (for example, Instrument Events).
Date
The Month, Day, and Year the event occurred.
Time
The time the event occurred in Hours, Minutes, and Seconds.
Description
Identifies the event or error that occurred.
Select Specific Event Classes
1
Select:
• Utils from the menu bar,
• 3 Event Log.
OR
Type 3 in the Option Number field and press (Enter) .
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11-7
11
Utilities
Event Log
2
Select the desired Classes. If no Classes are specified, all classes in the Event Log will be
retrieved.
3
Select Display to view the status of the desired event.
Information Options
After the Event Classes have been selected, the information can be formatted using the following
options.
Table 11.8 Event Classes Information Options
Option
Description
Display
Display Events - for reviewing events on the screen.
Copy
Copy to diskette - for saving events to a disk as a permanent record, for viewing on
another system or sending to Beckman Coulter.
Time
Date and Time selection - for selecting events for a specified date and time period.
Clear
Clear Events - for removing unwanted event information. To clear information,
select the event class(es) to be deleted and select the clear confirmation window.
Print
For creating a paper copy.
NOTE To save paper, before selecting Print, verify that only the desired event
classes for the appropriate time period are selected.
Done
To exit.
Show Events
11-8
1
Select the Event Log classes and a date/time range, if desired.
2
Select Display from the Event Log dialog box.
3
To transfer information to diskette, select Copy to Disk from the Display Events dialog box and
follow the instructions under "Copying to disk".
4
To print the information, select Print. This will print the entire selection, not just the page
currently shown.
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Utilities
Event Log
5
When finished viewing the information, select Close.
Additional Information
For additional information about corrective action for non-recoverable errors found in the Event
Log, refer to the CHAPTER 12, Troubleshooting Calibration and Result Errors in this manual.
Copy to a Disk
Follow the steps below to copy the Events to a disk. Copy will create a new file called elog1 without
deleting other files on the diskette. The file can then be opened using a word processing or
spreadsheet program or can be sent to Beckman Coulter for further investigation.
1
From the Events Log dialog box, select the event log classes and a date/time range if desired.
2
Select Copy from the Event Log dialog box.
OR
Select Copy to Disk from the Display Events dialog box.
3
Insert an MS-DOS formatted diskette into the disk drive.
4
Select OK to transfer information to a diskette.
OR
Select Cancel to exit without copying the information.
5
While the transfer is occurring the message, "Copying to Disk Please Wait..." appears.
NOTE If a damaged or write-protected disk is accidentally used to copy Event Log information, the
message "Copying to Disk Please Wait..." appears continuously. To exit from this condition, select
Cancel.
6
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Upon completion, "Copy Done" briefly appears before the screen returns to the Event Log dialog
box.
11-9
11
Utilities
Event Log
Specify the Date/Time
It is possible to select a date and time range to show only data from that time period. This
specification can be used alone to view all events for the specified date and time range or can be
combined with Class selections to view only those events which occurred for selected classes during
the specified date and time range.
When selecting a date and time the following rules apply:
• if a From date is entered but no End date, only data for that date is retrieved.
• if a To date is specified, a From date is required.
• if hours are entered, but no minutes, 00 minutes is used.
After selecting the desired Event Classes, follow the steps below to specify the desired date and time
period.
1
Select Time from the Event Log dialog box.
2
Type desired time period. Press (Tab) to advance the cursor to each field.
3
Select OK to accept the time period.
OR
Select Cancel to exit the Date/Time dialog box without specifying a date/time period.
4
Select Display to view selected information. When finished viewing the information, select
Close.
5
If desired, select Copy to Disk from the Display Events dialog box.
OR
Select Print. This will print the entire selection, not just the page currently shown.
11-10
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Utilities
Event Log
Clear Events
The Clear option is used to remove unwanted event information. It removes all events in the
selected classes even if a date/time range has been entered. If no classes are specified, the entire
Event Log is cleared.
1
Select the desired Event Log classes.
2
Select Clear from the Event Log dialog box.
3
Verify events to be cleared.
4
Select OK to remove specified events.
OR
Select Cancel to exit the Clear Events dialog box without clearing events.
Print an Event Log
The Print option will send the data in the currently selected classes and date/time range to the
printer. If no selections are made, the entire Event Log will be printed.
Print is available from both the Event Log dialog box without having to view the data first, or can be
selected from the Display Events dialog box. Print always sends the complete selection to the
printer. If a print of the current page/screen is required, press (PrtScn) from the keyboard.
IMPORTANT Use the Print function carefully when in the Event Log. Because there is a maximum of 100,000
events, printing the entire Event Log will take several minutes and many pages of paper to complete the
report.
1
Select the desired Event Log classes and a date/time range if desired.
2
Select Print from the Event Log dialog box.
OR
Select Print from the Display Events dialog box.
To stop the printer,
• Select Instr Cmd from the menu bar,
• Select 3 Stop Print.
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11-11
11
Utilities
Alignment/Diagnostics/PVTs
Alignment/Diagnostics/PVTs
Diagnostics and Alignment
• Diagnostics are tests used to confirm or isolate instrument problems.
• Alignment allows for adjustment of the various mechanical components.
• PVTs are Performance Verification Tests used to assess instrument performance.
Additional Information
Refer to the UniCel DxC Synchron Clinical Systems Reference Manual to access diagnostic testing
procedures and alignment instructions.
Metering
Reagent Metering
Reagent Metering provides reagent dispense counting and replenishment adjustments for those
instruments that are on a cost-per-test contract. Metering is only initialized on those instruments
with a cost-per-test contract.
Metered-Use Instruction Manual
Refer to the Synchron Clinical Systems Metered-Use Manual for instructions on usage.
Modem
The modem attached to the system provides the ability to electronically retrieve instrument data
and transmit it to Beckman Coulter.
Currently, there is no configuration required for the modem. Therefore, this option is grayed out.
The modem is automatically initialized upon instrument reboot.
11-12
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Utilities
Backup/Restore
Backup/Restore
Introduction
The Backup/Restore option provides the ability to store data to a diskette for use at a later time,
should an error occur that causes the loss of data. Backup is the process of saving data to a diskette
for safe storage. Restore takes previously backed up data from a diskette and places it back into the
system. The information is divided into two categories: System Parameters and Alignment Data,
each stored on a separate diskette.
System Parameters
System Parameters contains setup, e-maintenance log, reagent, and calibration information.
Alignment Data
Alignment Data includes all alignment information including photometer data.
Backup the System
The backup procedure should be performed following installation of a new software version, a
change in alignments or a change in system parameters, especially setup parameters. To perform
a backup, follow the steps below.
NOTE Alignment files are on a separate diskette from System Parameters. Depending on the instrument
configuration, System Parameters may require more than one diskette.
IMPORTANT Do not start a backup of System Parameters or Alignments while the printer is printing. If the
printer is printing, it will correctly stop before backup but will not restart when the backup is completed.
A reboot will be required to return the system to normal operation.
1
Select:
• Utils from the menu bar,
• 8 Backup/Restore,
OR
Type 8 in the Option Number field and press (Enter) .
2
Select the System Parameters box.
AND/OR
Select the Alignment Data Files box.
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11-13
11
Utilities
Backup/Restore
3
Select Backup. A warning message appears indicating that all host communication, and Print
functions will be disabled.
OR
Select Cancel to exit the dialog box without backing up the system.
4
Select OK. A slight delay occurs as the system prepares for the backup.
5
When prompted, insert a diskette into the disk drive. If both System Parameters and Alignment
Data Files are selected, the Alignment information will be copied first.
CAUTION
Selecting OK will prepare the diskette by ERASING it before copying data.
6
Select OK.
The diskette is then formatted and the backup files are created.
7
When the backup is complete, a confirmation message appears. Select OK.
8
Remove the diskette and label it with the following information:
 date of backup
 type of backup - System Parameters or Alignment Data
 current software and chemistry database version
 instrument serial number
• If both System Parameters and Alignment Data were selected, the Alignment Data diskette
is completed first.
— Store the diskettes in a safe place.
• If both System Parameters and Alignment Data were selected, Steps 5-8 are repeated for the
System Parameters.
Restore the System
System Parameter and Alignment data can be restored from the backup diskettes onto the system.
11-14
A13914AF
Utilities
Backup/Restore
CAUTION
Restoring System Parameters deletes all sample programming and results from
the hard drive. This includes QC, reagents onboard, and the calibration status.
NOTE If the software version on the backup diskette is different from the current software version, the
Restore function for System Parameters cannot be performed.
1
Select:
• Utils from the menu bar,
• 8 Backup/Restore.
OR
Type 8 in the Option Number field and press (Enter) .
2
Select the System Parameters box.
AND/OR
Select the Alignment Data Files box.
3
Select Restore.
OR
Select Cancel to exit without restoring.
4
Insert the backup diskette into the disk drive. If both System Parameters and Alignment Data
Files are selected, insert the Alignment diskette first.
5
Select OK. The date the backup was performed, type of backup, instrument serial number,
database version, and chemistry database version will be shown.
6
Select OK. The system prompts you to confirm you want to restore the database. Note that the
restore operation deletes the entire database.
7
Select OK. The restore will begin.
OR
Select Cancel to exit without restoring.
8
A13914AF
Upon completion of the Restore, a window appears prompting for the diskette to be removed.
Remove the diskette and select OK. The system automatically reboots.
11-15
11
Utilities
Touch Screen Calibration
Touch Screen Calibration
Introduction
Touch Screen Calibration adjusts the system so that a screen touch results in the selection of the
correct item. Perform touch screen calibration when:
• the touch screen is first installed,
• the monitor is moved (especially higher or lower), or
• screen touches do not select the correct item.
Parallax
Parallax affects touch screen selections; that is, an item on the screen apparently changes its
position when seen from different angles (side, top or front). Therefore, before the calibration,
install the monitor in a stable postition - at eye level, if possible.
Alignment Data
Alignment Data includes all alignment information including photometer data.
Procedure
Calibrate the touch screen in the same position (sitting or standing) as most operators work. Follow
the steps below to calibrate the touch screen.
1
Select the Utils icon from the menu bar.
2
Select 10 Touch Screen Calibration.
3
Use your finger or a pencil eraser and touch the target in the lower left corner for one second.
4
Repeat Step 3 for the target in the upper right corner. The system shows a new screen.
5
Repeat Steps 3-4 and the system saves the calibration automatically.
NOTE If you select the EXIT icon, the system will abort the calibration and disable the touch screen
function.
11-16
A13914AF
Index
Numerics
B
10% bleach solution, 9-80, 9-83, 9-84, 9-86, 9-112
1-Blade CTS option
See Cap piercer
1-Blade Narrow CTS, 2-5
1-Blade Thick CTS, 2-5
70% isopropyl alcohol, 9-14, 9-27, 9-31, 9-80
Backup, 11-13
Alignment data, 11-13, 11-16
System parameters, 10-2, 11-13
Bar code reader, 1-19
Hand-held (MC), 1-13
Reagent, CC, 1-19
Sample, 1-10
Bar codes, QC, 5-7
Printing, 5-7
Beer's Law, 1-54
Boot
Full boot, 10-14
Buttons, 1-xxxiv
A
Absorbance versus time, 7-8
AccuSense glucose sensor
Connector port, 9-59
Drain reaction cup for sensor, 9-58, 9-60
Gasket, 9-59, 9-61
Prepare prior to replacement, 9-60
Replace, six-month, 9-48, 9-60, 9-62
Stir bar and cup, clean, 9-62
Air filters
Change, 9-41
Clean, 9-41
Alarm/Annunciator
See Status Alarm/Annunciator
Alignment
See UniCel DxC Synchron Clinical Systems
Reference Manual
Alkaline buffer damper assembly
Adjust fluid level, 9-20
Fluid level high, 9-22
Fluid level low, 9-21
Check fluid level, 9-23
Replace alkaline buffer reagent, 9-18
Archive QC Data, 5-23
Auto ORDAC, 3-4
Auto serum index, 3-4
Autoloader, 1-9
C
Calibration
Acceptance limits, 4-27
Bypass, 4-25
Calibrator set point modifications, 4-28
Enzyme validator, 4-23
Error detection, 1-53
Extending calibration time, 4-26
Failure messages, 4-18
Formulas
Endpoint and first-order, 1-44–1-49
Non-linear, 1-50, 1-51
Override, 4-24
Reprint calibration report, 4-31
Request
Canceling a calibration request, 4-18
Slope offset adjustment, 4-29
Status, 4-14
Within-lot calibration, 4-19
Designations, 4-22
Enabling within-lot calibration, 4-19
Index-1
Index
Frequency, 4-19
Limitations, 4-22
Cap piercer
1-Blade CTS option
CTS Auto-Gloss
1-Blade Narrow CTS, 1-11
1-Blade Narrow CTS option, 9-32
1-Blade Thick CTS, 1-11
1-Blade Thick CTS option, 9-32
See CTS
Carousel, 1-6
Cartridge chemistries (CC), 1-43
Calibration theory, 1-43–1-53
Spectrophotometric methods, 1-54
Cartridges, 1-19
Reagent, 1-19
CC — Cartridge chemistry, 9-2
CC reagent mixer, clean, 9-31
CC sample mixer, clean, 9-31
CC sample probe, reagent probes and mixers
Automated cartridge chemistry probe
cleaning
Load CCWA, 9-103
CCWA — Cartridge chemistry wash solution, 9-2
Chemistry parameters, 8-4
Chemistry print name, defining, 3-6
Chemistry, configuring, 3-5
Clearing chemistries, 3-6
Deleting a chemistry, 3-6
Inserting a chemistry, 3-6
Chloride Electrode tip, Replace, 9-64
Closed Tube Sampling
See CTS
CO2 alkaline buffer reagent straw and line,
bleaching
Line #33, 9-86
CO2 measuring electrode membrane, 9-73
Broken, 9-78
ISE service, 9-74
Remove, 9-74
Replace, 9-76
Wrinkled, 9-78
Configuration, system, 3-31
Constituent code, 5-6, 5-11
Control, 5-9–5-14
Bar codes, 5-7
Constituent code, 5-6, 5-11
Definition, 5-4
Deleting, 5-13
Index-2
Editing, 5-9
Fields, 5-6, 5-11
File number, 5-6, 5-11
Printing, 5-13
QC chart, 5-17
QC file list, 5-14
QC summary, 5-15
Reviewing, 5-12
Copy to disk feature, 5-21
Creatinine clearance results
Calculation, 3-23
Critical ranges, 3-19
Critical Result Rerun, 3-15
Critical result rerun, 7-6
CTS — Closed Tube Sampling, 9-2
CTS (Closed Tube Sampling)
1-Blade Narrow CTS option, 1-11
1-Blade Thick CTS option, 1-11, 2-5
Blade count, 10-3
CTS Auto-Gloss, 2-v, 11-2
CTS Count, 10-3
CTS Tracking, 2-x, 10-7
4-Blade Foil CTS option, 2-5
CTS Auto-Gloss, 9-10
CUPs lamp and sensor calibration, 9-29, 9-30
Cuvette reaction system, 1-21
Cuvette washer probe, inspect
Blocked probe, 9-107
Cuvette washing
Wash station, 1-23
Cuvette water blank status, 10-6
Cuvette wiper
Reinstall, 9-12
Replace, 9-10
Cuvettes
Automated wash all cuvettes, 9-109
D
Data storage, 7-1
Results, 7-1
Sample programs, 7-1
Database version, 3-23
Date/time setup, 3-13
Deleted results, 11-7
Deleting, 5-19
Control, 5-12
Critical result rerun, 7-6
QC data point, 5-20
Demographics, 3-14
Index
Dilution factor, 6-10
Drain assembly, 1-26
Drugs of abuse testing (DAT), 1-53
E
Editing
Control, 5-9
EIC, 9-80
EIC — Electrolyte injection cup, 9-2
EIC ports, flushing, 9-80–9-86
ISE service, 9-80
Electrolyte injection cup (EIC), 1-15
Electrostatic Discharge, 9-1
Enable/disable modules, 10-16, 10-17
Enzyme validator, 4-23
Enzyme verification, 1-53
Error detection
See Calibration
Error detection limits, 8-13
Event log, 11-6
Exit check criteria, 8-17, 8-18
Expanded user defined chemistry feature, 8-20
Extinction coefficients, 8-16
F
Failure messages, calibration, 4-18
File number, 5-6, 5-11
Flow cell (ISE), 1-16
Flow cell flush kit, 9-91
Flow cell tubing #23, 9-92
Flow cell tubing #27, 9-92
Flow cell tubing #35, 9-92
Flow cell, flushing
ISE service, 9-91–9-94
H
Hazards, 2-v
Home, 10-8
Host specifications
See Host Interface Specifications Manual (P/
N A16150)
Hydropneumatic system, 1-24
Status, 10-5
I
Icons, 1-xxxiv
ICS/smart module status, 10-5
Immediate reporting, 3-14
Instrument commands, 10-8
Intended use, 1-xxxiii
ISE — Ion selective electrode (flow cell
module), 9-2
ISE drain cleaning, six-month
Drain top, 9-89
Drip screen, 9-89
ISE service, 9-88, 9-91
ISE module, 1-13
ISE reference solution, 9-52
ISE service, 9-54, 9-64
K
Keyboard, 3-29
L
Labels, 2-xv–2-xxiii, ??–2-xxiv
Language/keyboard, selection, 3-29
Levey-Jennings, 5-16
Log fields, 1-40, 1-41
LPIA (large particle immuno assay)
module, 1-21, 1-22, 8-1, 8-6, 10-6
M
Main screen, 1-27–1-42
Post run summary, 1-39, 1-42
Pre run summary, 1-39, 1-42
Results recall, 1-38, 1-39
Sample unload, 1-39
Main screen and program structure, 1-27
Maintenance, 9-1, 11-6
Manual
Conventions, 1-xxxiii
How to use, 1-xxxv
Scope, 1-xxxiii
Manual assignments, 6-7
Math models, 1-50, 1-51, 8-6
MC — Modular chemistry, 9-2
MC components, reassemble, 9-30
Mixer wash cup, 1-20
Reagent, 1-20
Modem, 11-12
Modular chemistries (MC), 1-53
Basic components, 1-17
Modular reagents
Index-3
Index
No Foam, 9-10
Manual assignments, 6-7
ORDAC, 6-10
Rack status, 6-3
Rack/cup position, 6-4
Sample ID, 6-4
Sample status, 6-4
Pushers, 1-10
O
Q
Offload track, 1-9
On/off switch, 10-13
ORDAC, 6-10
Auto ORDAC, 3-4
Manual, 6-10
QAP Disk, 5-21
Quad-ring
BUNm/UREAm electrode, 9-27
CO2 measuring electrode, 9-75
Potassium and calcium electrode, 9-56, 9-66
Quality Assurance Program (QAP)
Copy to disk feature, 5-21
Quality control (QC), 5-1–5-25
Chart, 5-16
Printing QC bar code assignments, 5-7
QC action log, 5-20
QC chart, 5-16
QC file list, 5-14
Displaying, 5-14
QC log, 5-18
Summary, 5-15
Check levels, 9-10
Modules, 1-17
Modules, enable/disable, 10-16
N
P
Panels, 3-15
Patient results
Critical results rerun, 3-14, 3-19, 7-6
Pause, 10-9
PHOSm, cleaning precipitate
Protein precipitate, 9-105
Photometer assembly, 8-6
Post run summary, 1-39, 1-42
Potassium and calcium electrode tips
Replacing, six-month
ISE service, 9-54
Removing/installing, 9-52–9-58
Power Subsystem Status, 10-4
Pre run summary, 1-39, 1-42
Precautions, 2-viii–2-xiv, 5-9
Prime, 11-1
Printers, 3-30
Printing, 5-13, 7-7
Control, 5-13
Data, 1-38
QC chart, 5-17
QC file list, 5-14
Recalled results, 7-7
Priority
Position, 1-9
Priority load, 1-9
Probes, clean, 9-14
Processing parameters, 8-8
Programming samples, 6-1
Batch, 6-11
Dilution factor, 6-10
Manual, 6-10
Index-4
R
Racks, 1-7
Sample, 1-7
Sizes, 1-7
Status, 6-3
Ratio pump, 1-14
Reaction carousel, 1-21
Cuvettes, 1-21
Reaction type, 8-4
Reagent carousel, 1-19
Reagent cartridges, 1-18
Reagent handling system, CC, 1-17
Reagent parameters, 4-10
Loading, 4-11
Reagent status
Sorting reagent status
Days left, 4-3
Tests left, 4-3
Reagent syringe, 9-43
See also Sample and reagent syringes,
replacing three-month
Recalling results
Index
Displaying, 7-5
On-board samples, 1-38
Patient ID, 7-4
Printing, 7-7
Rack and position, 7-3
Run date/time, 7-4
Sample ID, 7-2
Replicates, 3-16
Reportable range, 3-17
Reports, 3-16
Statistical summary, 7-10
Reserved racks, assigning, 2-xiii
Reset, 10-12
Restore, 11-13
Results, 1-39
Results recall, 1-38, 7-1
Main screen, 1-38
Retainer nut, 9-26, 9-56, 9-61, 9-66
Review, 5-24
Review results, 1-41
Reviewing, 5-12
S
Sample
Carousel, 1-12
Gate, 1-10
Handling system, 1-6
ID, 6-5
Log, 1-39–1-41
Programming
See Programming samples
Racks, 1-7, 2-2
Replicates, 3-16
Type
Default, 3-13
Sample and reagent syringes, replacing threemonth
Checking for bubbles, 9-47
Plunger rods, 9-44
Syringe rod replacement, 9-44
Sample syringe, 9-43
CC sample syringe, 9-44
MC sample syringe, 9-44
Serum index
Auto ORDAC, 3-4
Serum Index result, 3-15
Service
Monitor, 3-27
See also Metering Manual (P/N 967259)
Setup, 3-30
Setup
Screens, 3-1
Shutdown, 10-12
Shuttle, 1-10
Silicone compound, 9-28
Smart modules
Status, 10-5
Sodium Azide preservative, 2-vii
Software version, 3-23
Special calculations, 3-20
Specifications, system
Clearances, 1-2
Elevation, 1-3
Operating temperature, 1-3
STAT, 3-14
Statistical summary report, 7-10
Status
Alarm/Annunciator, 3-32
See also System status, 10-1
Status-cycle count, 10-2
Stop print, 10-11
Surfaces and covers, cleaning, 9-111
Symbols, 2-xv–2-xxiii, ??–2-xxiv
System configuration, 3-31
System description, 1-1
System hazards
Moving parts, 2-vi
System Status, 10-1
T
Tables, 3-10
Beckman Coulter defined chemistries, 3-10
Predefined special calculations, 3-21
Predefined special formulas, 3-21
Temperatures, 10-2
Timed urine results
Constants and factors, 3-23
Total protein cup maintenance, 9-13
Touch Screen Calibration, 11-16
U
Unload all, 10-18
Unloading samples, 1-39
Update, 3-31
See Version upgrade
UPS (Uninterruptible Power Supply), 10-13
User, 8-3
Index-5
Index
User defined reagents
Configuring, 3-5
Defining, 8-3–8-19
Deleting, 3-6
Inserting, 3-6
Minimum operating requirements, 8-1
Removing, 8-19
Setup, 3-24, 8-3
V
Valid entries, 6-5
Version information, 3-23
Version upgrade, 3-31
W
Warnings, reagent and calibration status, 4-15
Wash Concentrate II, 9-10
Waste B, pause/resume, 10-15
Wavelength
Primary, 8-6, 8-15
Secondary, 8-6, 8-15
Westgard rules, 5-2, 5-3
Wheel
See Carousel
Wrist ground strap, 9-43
Index-6
Related Documents
Synchron Clinical Systems
Chemistry Information Manual and
Synchron Clinical Systems Chemistry
Reference Manual
•
Contain specific chemistry information for
the full range of analytes available on UniCel
DxC and Synchron LX Systems.
Synchron Clinical Systems
Performance Verification Manual
•
Helps you integrate the UniCel DxC System
into your laboratory.
Synchron LX/UniCel DxC Clinical Systems
Sample Template
•
This template is used to determine if
primary tube samples have at least 264 μL of
sample available for testing. This volume of
sample is sufficient to run most 20-test
general chemistry panels.
UniCel DxC 600 and DxC 800 Synchron Clinical
Systems In-Lab Training Manual
•
Used to train laboratory personnel on
DxC 600 and 800 routine operations.
UniCel DxC 600 and DxC 800 Synchron Clinical
Systems Operator Tips
•
Provides a summary of frequently used
information about your system and the
chemistries used.
UniCel DxC Synchron Clinical Systems
Host Interface Specifications
•
Contains the necessary information to
interface UniCel DxC Systems to a
Laboratory Information System (LIS).
UniCel DxC Synchron Clinical Systems
Reference Manual
•
www.beckmancoulter.com
Contains detailed operating instructions
and supplemental maintenance and
troubleshooting guidelines for UniCel DxC
Systems. It also contains information about
the UniCel DxC Systems, such as theory of
operation, system specifications and safety
information.
© 2010 Beckman Coulter, Inc.
All Rights Reserved
Instructions For Use
Volume 2
UniCel® DxC Synchron®
Clinical Systems
For In Vitro Diagnostic Use
This manual is intended for
UniCel® DxC 600
UniCel® DxC 800
UniCel® DxC 600i
A13914AF
April 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
Instructions For Use
UniCel DxC Synchron Clinical Systems
PN A13914AF (April 2010)
Copyright © 2010 Beckman Coulter, Inc.
Trademarks
Following is a list of Beckman Coulter trademarks
• AccuSense®
• Array®
• Microtube™
• SPINCHRON™
• Synchron®
• Synchron LX®
• UniCel®
All other trademarks are the property of their respective
owners.
Find us on the World Wide Web at:
www.beckmancoulter.com
Beckman Coulter Ireland, Inc.
Mervue Business Park, Mervue Galway, Ireland 353 91 774068
Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda
Estr dos Romeiros, 220 - Galpao G3 - Km 38.5
06501-001 - Sao Paulo - SP - Brasil
CNPJ: 42.160.812/0001-44
製造販売元 : ベ ッ ク マ ン・ コ ール タ ー株式会社
東京都江東区有明三丁目 5 番 7 号
TOC 有明ウエ ス ト タ ワー
贝克曼库尔特有限公司,
美国加利福尼亚州,Brea 市,S. Kraemer 大街 250 号,
邮编:92821 电话:(001) 714-993-5321
Contents
Revision History, iii
Safety Notice, v
Introduction, xxxiii
CHAPTER 1:
System Description, 1-1
System Description, 1-1
Operational Conditions, 1-1
System Components, 1-5
Sample Handling System, 1-6
Modular Chemistry (MC) System, 1-12
Cartridge Chemistry (CC) Reagent Handling System, 1-17
Cuvette Reaction System, 1-21
Hydropneumatic System, 1-24
Operation and Control Components, 1-26
Main Screen and Program Structure, 1-27
Theory of Operation, 1-43
Cartridge Chemistry: Calibration Theory, 1-43
Modular Chemistry: Calibration Theory, 1-53
Cartridge Chemistry: Principles of Measurement, 1-54
CHAPTER 2:
Preparing Samples for Analysis, 2-1
Routine Operation Overview, 2-1
Preparing Samples for Analysis, 2-2
How to Use Reserved Racks, 2-7
xxvii
Contents
CHAPTER 3:
System Setup Options, 3-1
Overview, 3-1
Password Setup, 3-2
Auto Serum Index/ORDAC, 3-4
Configuring the Chemistry Menu, 3-5
Setting the Default Sample Type, 3-13
Date/Time Setup, 3-13
Demographics Setup, 3-14
Patient Results – Immediate Reporting Setup, 3-14
Panels, 3-15
Replicates, 3-16
Report Setup, 3-16
Reportable Ranges Setup, 3-17
Reference/Critical Ranges Setup, 3-19
Sample Comments Setup, 3-19
Special Calculations Definition, 3-20
Timed Urine and Creatinine Clearance Results, 3-23
Version Information, 3-23
Units/Precision Setup, 3-24
User Defined Chemistries Setup, 3-24
Bar Code Setup, 3-25
Maximum Sample Program Age, 3-26
Reserved Racks/Obstruct Detect, 3-26
Disable Service Monitor, 3-27
Host Communications, 3-28
Language/Keyboard Setup, 3-29
Printer Setup, 3-30
Service Setup, 3-30
System Configuration, 3-31
Version Upgrade, 3-31
Status Alarm/Annunciator, 3-32
Chemistry Update, 3-32
Auto Generation of Control, 3-33
xxviii
Contents
CHAPTER 4:
Reagent Load/Calibration, 4-1
Reagent Load, 4-1
System Calibration, 4-12
Load a Calibrator Diskette, 4-12
Calibrator Assignment, 4-13
Calibration Status, 4-14
Reagent and Calibration Status Warnings, 4-15
Request a Calibration, 4-16
Calibration Failure Messages, 4-18
Within-Lot Calibration, 4-19
Enzyme Validator, 4-23
Calibration Override, 4-24
Chemistry Bypass, 4-25
Extend Calibration Time, 4-26
Calibration Acceptance Limits, 4-27
Calibrator Set Point Modifications, 4-28
Slope Offset Adjustment, 4-29
Reprint Calibration Reports, 4-31
CHAPTER 5:
Quality Control, 5-1
Quality Control, 5-1
Define a Control, 5-4
Control ID Assignments, 5-7
Run Control Samples, 5-7
Edit a Control Definition, 5-9
Review a Control Definition, 5-12
Delete a Control, 5-12
Print QC Ranges, 5-13
QC File List, 5-14
QC Summary, 5-15
QC Chart (Levey-Jennings), 5-16
QC Log, 5-18
Quality Assurance Program (QAP) “Copy To Disk” Feature, 5-21
Archive QC, 5-23
xxix
Contents
Review Archived Data, 5-24
CHAPTER 6:
Sample Programming and Processing, 6-1
Overview, 6-1
Prior to Programming, 6-2
Identify Samples, 6-4
Sample Programming and Processing, 6-6
Additional Programming Information, 6-10
Clear Samples, 6-12
CHAPTER 7:
Results Recall, 7-1
Overview, 7-1
Recall Results by Sample ID, 7-2
Recall Results by Rack and Position, 7-3
Recall Results by Patient ID, 7-4
Recall Results by Run Date/Time, 7-4
Display Recalled Results, 7-5
Edit Critical Rerun Result, 7-6
Print Recalled Results, 7-7
Send Results to the Host, 7-8
Absorbance Versus Time, 7-8
Statistical Summary Report, 7-10
CHAPTER 8:
User Defined Reagents, 8-1
Overview, 8-1
Requirements and Precautions, 8-1
User-Defined Reagent Setup, 8-3
Chemistry Parameters, 8-4
Processing Parameters, 8-8
Error Detection Limits, 8-13
Wavelength Selection, 8-15
Determination of Extinction Coefficients, 8-16
Exit Check Criteria, 8-17
User Defined Reagent Removal, 8-19
Expanded User Defined Chemistry Feature, 8-20
xxx
Contents
CHAPTER 9:
Maintenance, 9-1
Overview, 9-1
Electronic Maintenance Log, 9-4
Twice Weekly Maintenance, 9-7
Weekly Maintenance, 9-9
Check Chloride Calibration Span, 9-18
Monthly Maintenance, 9-19
Two-Month Maintenance, 9-38
Three-Month Maintenance, 9-45
Four-Month Maintenance, 9-50
Six-Month Maintenance, 9-54
As-Needed/As-Required Maintenance, 9-66
CHAPTER 10:
System Status and Commands, 10-1
Overview, 10-1
System Status, 10-1
Status-Cycle Count, 10-2
Temperatures, 10-3
Show Temperature Status, 10-3
Power Subsystems, 10-4
Hydropneumatics Subsystem, 10-4
ICS/Smart Modules, 10-5
Cuvette Water Blank Status, 10-6
CTS Tracking, 10-7
Instrument Commands, 10-8
Home, 10-8
Pause, 10-9
Stop Print, 10-11
Shutdown, 10-12
System Power On/Boot, 10-14
Pause/Resume Waste B, 10-15
Enable/Disable Modules, 10-16
Unload All, 10-18
xxxi
Contents
CHAPTER 11:
Utilities, 11-1
Overview, 11-1
Prime, 11-1
Maintenance, 11-6
Event Log, 11-6
Alignment/Diagnostics/PVTs, 11-12
Metering, 11-12
Modem, 11-12
Backup/Restore, 11-13
Touch Screen Calibration, 11-16
CHAPTER 12:
Troubleshooting Calibration and Result Errors, 12-1
Calibration Errors, 12-1
MC Calibration, 12-2
Linear Calibration, 12-7
Non-Linear and Multipoint Calibrations, 12-10
Troubleshooting Result Errors, 12-13
Error Codes and Definitions, 12-14
Error Code – Definitions, 12-17
Common Error Messages and Corrective Actions, 12-1
Glossary, Glossary-1
Index, Index-1
Related Documents
xxxii
CHAPTER 12
Troubleshooting Calibration and Result Errors
Calibration Errors
Introduction
The following pages contain descriptions of calibration reports for linear, non-linear, electrolyte
module, and cup module chemistries and explanations of what each field on the report is used for
when calibrating each chemistry type.
Calibration Error Checking
Calibration and Result Error checking is used to flag system and reagent issues. Error checking is
performed on the final result and on interim steps of the reaction. The error flags may be directed
to a calculated calibration factor or to any of the interim data used to generate a final calibration
result. The flags may be indicative of a variety of different hardware, reagent, or sample (calibrator)
issues and can be used to troubleshoot different system issues. Any calibrator or sample outside of
any one or more calibration limits will be flagged.
Calibration Error Flags
Table 12.1 below is a general list of the calibration errors for linear, multipoint, and MC calibrations.
These errors are listed in the "Failed Calibration Report" area of the calibration report. Descriptions
of each of the calibration error flags are listed, in more detail, by calibration type in the following
sections.
Table 12.1 Calibration Error and Remarks
Printed Flag
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Remarks on Report
Description
BACK TO BACK
Calibration failed
Precision error.
CAL FAILED
Calibration failed
Calibration failed.
CHEM DB ERROR
Chemistry database error.
HI REAGENT
High reagent level.
LO REAGENT
Low reagent level.
12-1
Troubleshooting Calibration and Result Errors
MC Calibration
Table 12.1 Calibration Error and Remarks (Continued)
Printed Flag
MATH ERR
Remarks on Report
Calibration required
NO SAMP DETECT
Description
Math error – Calibration does not
fit expected model.
No sample detected.
OCR HIGH
Calibration failed
Response out of range high.
OCR LOW
Calibration failed
Response out of range low.
RECOVERY
Calibration failed
Recovery error
SENSITIVITY
Calibration failed
Sensitivity error
SEV RECOVERY
Calibration required
Severe recovery error
SEV SENSITVITY
Calibration required
Severe sensitivity error
SPAN
Calibration failed
Sensitivity error
RANGE
Calibration failed
Accuracy error (ISE)
MC Calibration
Overview
The DxC calibrates MC chemistries using two or three calibrator levels. Four replicates are assayed
per calibrator level. Of the four replicates, only the two middle values are used to set calibration.
The highest and lowest values are discarded. The analog signals generated by the calibrator
measurements are converted to digital form (ADC values). The resulting ADC values are compared
to pre programmed error limits for back-to-back, span, and calibrator range to determine the
integrity of the calibration.
MC Calibration Checks
Both results and interim data are error checked when calibrating a chemistry. Standard results
errors, as well as interim error flags, are applied to the calibration data.
Back-to-Back
• The back-to-back error check is a measure of system precision during calibration.
• A back-to-back value is the difference between the two middle Sample-Reference replicate
values within a calibration level. If the back-to-back limit is exceeded the calibration fails.
• Only the two replicates that meet back-to-back are used; all other replicates are discarded.
• Select Calibrator Acceptance Limits under Options in the Rgts/Cal screen to view current
calibration limits.
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Troubleshooting Calibration and Result Errors
MC Calibration
Calibrator Range (High/Low)
• The Calibrator Range (High/Low) error check is a measure of reagent and electrode
performance or accuracy.
• Calibrator ADC values are compared to acceptable ranges for calibrator values. Calibration fails
if the calibrator ADC values fall outside the acceptable calibrator limits.
• Select Calibrator Acceptance Limits under Options in the Rgts/Cal screen to view current
calibration limits.
DAC
• The DAC error check verifies proper operation of electrodes.
• The Digital-to-Analog Conversion (DAC) check mimics expected ranges of electrode output.
Failure to detect an output within a predetermined range for each channel will trigger a DAC
ERROR flag for the specific electrolyte.
• Limits are as shown in Table 12.2.
Table 12.2 Digital-to-Analog Conversion (DAC) Check Limits
Chemistry
A13914AF
DAC Limits
Low
High
NA
400
5,400
K
-5,900
-900
CL
-2,300
2,700
CO2
-30,000
-20,000
CALC
-125
4,875
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Troubleshooting Calibration and Result Errors
MC Calibration
Sample/Reference Deviation
• The Sample and Reference deviation error checks are used as a measure of noise for
electrolytes.
• Each Sample ADC and each Reference ADC is actually an average of ten readings.
• The difference between the high and low values (deviation) of the ten electrode readings (taken
milliseconds apart) must be within the maximum deviation.
• Maximum deviations are as shown in Table 12.3 below:
Table 12.3 Maximum Allowable Sample/Reference Deviations by Chemistry
Chemistry
Maximum Deviations
Sample
Reference
NA
200
200
K
150
150
CL
200
200
CALC
150
150
Span
• Span is a measure of sensitivity and verifies that two consecutive calibrator level ADC values are
a minimum distance apart.
• The difference between the average ADC value of Calibrator 1 and the average ADC value of
Calibrator 2 or between the average ADC value of Calibrator 2 and the average ADC value of
Calibrator 3 must exceed the minimum span limit.
• Select Calibrator Acceptance Limits under Options in the Rgts/Cal screen to view current
calibration limits.
Calibration Reports
The Calibration Report can be a useful tool for identifying issues. Table 12.4 below defines the Fields
in the order they are shown for each chemistry on a typical ISE Module Calibration Report.
Table 12.4 ISE Module Calibration Report Field Definitions
Field
Sample Reference
Description
The difference between the sample and reference ADC values. This is used
for the back-to-back, range, and span checks.
For CO2, the sample reference value is the ratio between the sample and
reference readings.
Sample
The average of eight ADC readings of the calibrator sample.
For CO2, the sample ADC represents the rate of pH change initiated by the
calibrator sample.
12-4
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Troubleshooting Calibration and Result Errors
MC Calibration
Table 12.4 ISE Module Calibration Report Field Definitions (Continued)
Field
Description
Sample Deviation
Each sample ADC is actually an average of eight readings. The ADC
difference between the minimum and maximum readings must be less
than the predefined limits a noise flag will occur. This does not apply to CO2.
Reference
The average of the eight ADC readings corresponding to the measurement
of the Electrolyte Reference Solution.
For CO2, the reference ADC represents the rate of pH change initiated by
the reference reagent.
Reference Deviation
Each reference ADC is actually an average of eight readings. The ADC
difference between the minimum and maximum readings must be less
than the predefined limits, otherwise a noise flag will occur.
Span
The difference between the average of the Sample-Reference values
reported for each calibrator level. The value is compared to an expected
value and if the calculated span is less than the expected span, the
calibration is flagged.
Set Point
The concentration value assigned to the calibrator level.
Set Point Units
The units assigned to the set point value.
Replicates Used
The field indicating which replicate of a calibrator level is used for a
particular chemistry.
Failed Calibration Log (ERR)
The fields listed below categorize information about a failed calibration.
Multiple errors are shown here for any chemistry failure. The errors should
correlate with any of the asterisked (*) fields listed within the calibration
report. This section of the report appears only when a calibration fails.
• Reagent – Identifies the failed chemistry.
• Level – Identifies the calibrator level which failed.
• Condition – In the event that an error occurs, an asterisk (*) appears
next to the value which is out of specification. The corresponding error
flag will print in this field. Only those errors that FAIL the calibration will
print.
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Troubleshooting Calibration and Result Errors
MC Calibration
Table 12.5 below defines the Fields in the order they appear for each chemistry on a typical MC
Calibration Report.
Table 12.5 Cup Module Calibration Report Field Definitions
Field
Description
Rate
Represents the rate of change in ADCs during the reaction. Rate is used for
back-to-back, span and range checks.
Initial Read
Represents the conductance measured by the electrode or absorbance
measured by detector with only reagent present in the cup.
Final Read
Represents the conductance measured by the electrode or absorbance
measured by detector after the reaction has taken place.
Set Point
The value assigned to the calibrator level.
Set Point Units
The units assigned to the set point value.
Replicates Used
The field indicating which two of the four calibrator replicates are used for
a particular chemistry.
Span
The difference between the average of the values reported for rate for each
calibrator level. This value is compared to an expected value; if the
calculated span is less than the expected span, the calibration is flagged.
Failed Calibration Log (ERR)
The fields listed below categorize information about a failed calibration.
Multiple errors are shown here for any chemistry failure. The errors should
correlate with any of the asterisked (*) fields listed within the calibration
report. This section of the report appears only when a calibration fails.
• Reagent – Identifies the failed chemistry.
• Level – Identifies the calibrator level which failed.
• Condition – In the event that an error occurs, an asterisk (*) appears
next to the value which is out of specification. The corresponding error
flag prints in this field. Only those errors that FAIL the calibration prints.
12-6
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Troubleshooting Calibration and Result Errors
Linear Calibration
Linear Calibration
Overview
For all linear photometric chemistries, the UniCel DxC sets calibration based on two or four
calibrator replicates.
• For calibrations using four replicates, the instrument will determine and discard the highest
and lowest values of the four replicates. The remaining two values are called the usable
calibrator replicates. Only the two usable replicates will be used for the calibration calculations.
The average value of the usable calibrator replicates is used to determine the calibration factor.
• For calibrations using only two replicates, the instrument uses the average of both replicates in
determining the calibration factor.
Calibration fails if one or more of the usable replicates is flagged.
Linear calibration chemistries include Endpoint and First Order reactions. For additional
information about linear calibration or for specific calibration equations, refer to CHAPTER 1,
System Description, Endpoint and First-Order Chemistries and Endpoint and First-Order Calibration
Formulas.
Calibration flags that are specific to the linear photometric chemistries, causing the reagent to fail
its calibration, are back-to-back and Calibrator Range (High/Low) errors, and for linear chemistries
that use more than one calibrator, Span.
To view the calibration flag limits for all calibrated chemistries, access View Calibrator Acceptance
Limits in the Rgts/Cal screen under Options. Calibration flags for any chemistry with loaded
calibration data are available to view and print.
Back-to-Back
• A back-to-back error check is a measure of system precision during calibration.
• A back-to-back value is the difference between the two usable replicate values. If the back-toback limit is exceeded the calibration fails.
• Limits are either pre-programmed in the system chemistry database or downloaded from disk
before calibration.
Calibrator Range (High/Low)
• Calibrator Range (High/Low) error check is a measure of reagent performance or accuracy.
• Calibrator ADC values are compared to acceptable ranges for calibrator values. Calibration fails
if the calibrator ADC values fall outside the acceptable calibrator limits.
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Troubleshooting Calibration and Result Errors
Linear Calibration
Span
• Span is a measure of the sensitivity of the reagent and verifies that two consecutive calibrator
levels values are a minimum distance apart.
• The difference between two consecutive calibrator rates or absorbances must exceed the
minimum limit or the reagent fails calibration.
Linear Calibration Report
The calibration report can be a useful tool for identifying issues. Table 12.6 below defines the fields
in the order they appear for each chemistry on a typical Linear Calibration Report.
Table 12.6 CC Linear Calibration Report Field Descriptions
Field
Reagent Identifiers
Description
The following fields identify specific cartridge information.
•
•
•
•
•
Rgt – Indicates which chemistry is being calibrated.
Units – Selected units shown for reference.
S/N – Specifies the serial number of the reagent cartridge being calibrated.
Lot – Identifies the lot number of the specific cartridge.
Loc – Identifies the location of the reagent cartridge on the reagent
carousel.
Cuv
The cuvette number on the reaction carousel in which the reaction took place.
Set Points
The target value for the calibrator.
Blank
The blank absorbance when it is an ENDPOINT chemistry or the blank rate
(absorbance per unit time) when it is a RATE chemistry.
Reaction
The reaction absorbance when it is an ENDPOINT chemistry or the reaction rate
(absorbance per unit time) when it is a RATE chemistry. For ENDPOINT 2 or RATE
2 reactions, the blank absorbance or blank rate must be subtracted from this
value to obtain the net delta absorbance.
The calibration is calculated using the two middle reaction values; the highest
and lowest values are not used. Back-to-back error checking is performed on
the mid reaction values.
Recovery
12-8
The value obtained when the final absorbance of each of the replicates used is
multiplied by the determined Calibration Factor. This is the value that would be
obtained if the calibrator was run as a sample using this calibration. The closer
the recovery of the calibrator is to the setpoint, the better the calibration is.
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Troubleshooting Calibration and Result Errors
Linear Calibration
Table 12.6 CC Linear Calibration Report Field Descriptions (Continued)
Field
Calibration Error Log
Description
The fields listed below categorize information about a failed calibration.
Multiple errors are shown here for any chemistry failure. The errors should
correlate with any of the asterisked (*) fields listed within the calibration report.
This section of the report appears only when a calibration fails.
• Reagent – Identifies the failed chemistry.
• Lot Number – Identifies the lot number of the reagent which failed
calibration.
• Serial Number (S/N) – Identifies the serial number of the specific cartridge
which failed.
• Cuvette – Identifies the cuvette in which the specific replicate failed.
• Condition – In the event that an error occurs, an asterisk (*) appears next
to the value which is out of specification. The corresponding error flag will
print in this field. Only those errors that FAIL the calibration will print.
• Value – Shows the absorbance value that failed calibrator or reaction limits.
• Magnitude – This is an indication of the severity of the failure. Depending
on the error, the magnitude may reflect the actual value of the error or it
may show the absolute difference between the limit and the actual value.
Likewise, the magnitude may not be applicable to the error which has
occurred. If this is the case, no value will appear under this field.
Error Flag
A13914AF
Magnitude
BLANK RATE
absolute delta
BLANK ABS
absolute delta
RXN RATE
absolute delta
RXN ABS
absolute delta
INIT ABS HI
actual value
INIT RATE HI
actual value
BACK TO BACK
absolute delta
OCR
absolute delta
All others
no magnitude
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Troubleshooting Calibration and Result Errors
Non-Linear and Multipoint Calibrations
Non-Linear and Multipoint Calibrations
Overview
Non-linear chemistries include drugs and specific protein assays. The calibration curves for nonlinear calibrations are logarithmic or have other non-linear relationships.
Non-linear chemistry calibrations may have single level or multilevel calibrators.
• Multipoint calibrations are based on a single determination of each calibrator level (five or six
levels). The standard curve is determined by use of one of several non-linear math models.
• Single point non-linear calibrations are based on one or two levels of calibrators. These
chemistries set calibration based on two to four replicates of each calibrator level.
Failed Multipoint calibration errors will be noted with an (*) at the bottom of the calibration report.
Refer to CHAPTER 1, System Description, Non-Linear Chemistries and Non-Linear Calibration
Formulas for additional information on this subject.
Non-Linear Calibration Checks
Non-linear calibrations have a set of calibration checks specific to non-linear calibrations.
• The first check determines whether the data is reasonable to attempt the curve fitting.
• The second check determines whether the Multipoint span is within acceptable limits.
The next set of errors are inherent to non-linear curve fitting and may or may not cause calibration
failure. Under certain conditions the curve fitting will produce parameters and curves that may
contain mathematical errors. Typically these errors occur outside of the reagent dynamic range and
have no effect on sample recovery. Math errors may be either overrideable or non-overrideable
depending on the severity of the failure. Math errors are reported as "MATH ERROR #" with the
number associated with a specific error that has occurred.
Multipoint Span
• The Multipoint Span flag is a measure of sensitivity over the entire standard curve.
• This is the difference between consecutive calibrator rates or absorbencies. There can be up to
six Multipoint spans for Level 0–1, 1–2, 2–3, 3–4, 4–5, 5–0.
Recovery
The Recovery Flag determines whether recovery errors for each calibration level are too large for a
calibration to be useful. The difference between the recovered concentration and the actual
concentration exceeds specification. This error is overrideable.
12-10
A13914AF
Troubleshooting Calibration and Result Errors
Non-Linear and Multipoint Calibrations
Severe Recovery
Severe Recovery is a non-overrideable extreme recovery error. Refer to RECOVERY error.
Sensitivity
Sensitivity is a check of the calibration slope for each calibrator level and several intermediate levels
to check if the response is too high or low. This error is overrideable.
Severe Sensitivity
Severe Sensitivity is a non-overrideable extreme sensitivity error. Refer to SENSITIVITY error.
Math Errors
These errors occur when the calibration graph is being established and the curve is being fit to a
specific non-linear curve model. Also, there is a math error with a single point non-linear curve to
show that the scale factor obtained during calibration is too far from the expected scale factor.
Calibration Report
The CC Non-Linear and Multipoint Calibration Reports can be a useful tool for identifying issues.
Table 12.7 below provides definitions of specific calibration fields found on those two reports.
Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions
Field
Reagent Identifiers
Description
The following fields identify specific cartridge information.
•
•
•
•
•
•
A13914AF
Rgt – Indicates which chemistry is being calibrated.
Units – Shows selected units for reference.
S/N – Specifies the serial number of the reagent cartridge being calibrated.
Lot – Identifies the lot number of the specific cartridge.
Loc – Identifies the location of the reagent cartridge on the reagent carousel.
Math Model – Identifies the specific Math Model used to calculate the curve
parameters.
Cuv
The cuvette number on the reaction carousel in which the reaction took place.
Level
The level of calibrator being run.
Set Points
The target concentration value for the calibrator level.
Blank
The blank absorbance when it is an ENDPOINT chemistry or the blank rate
(absorbance per unit time) when it is a RATE chemistry.
Reaction
The reaction absorbance when it is an ENDPOINT chemistry or the reaction rate
(absorbance per unit time) when it is a RATE chemistry. For ENDPOINT 2 or RATE
2 reactions, the blank absorbance or blank rate must be subtracted from this
value to obtain the net delta absorbance.
12-11
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Troubleshooting Calibration and Result Errors
Non-Linear and Multipoint Calibrations
Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions (Continued)
Field
Description
Recovery
The concentration obtained when the final calibrator absorbencies are applied
to the calculated curve.
Deviation
The difference between the obtained absorbance value and the curve in terms
of absorbance.
Standard Deviation
of the Curve
The standard deviation of all the calculated deviation values. An indication of
curve fit.
Curve Parameters
(R0, Kc, R, Conc, a, b, c) Positioning and scaling factors for curve determination.
• R0 – Calculated response for a zero sample
• Kc – Scale parameter
• R – Sample Response
• Conc – Standard
• a, b, c – Parameters which define the non-linear elements of the math model
Calibration Error Log
Several fields are shown for information on a failed calibration. Multiple errors
are shown here for any chemistry failure. The errors correlate with the fields
with asterisks, listed in the calibration report. This is only shown if a calibration
fails.
• Reagent – Identifies the failed chemistry.
• Lot Number – Identifies the lot number of the reagent which failed
calibration.
• Serial Number (S/N) – Identifies the serial number of the specific cartridge
which failed.
• Cuvette – Identifies the cuvette in which the specific replicate failed.
• Condition – In the event that an error occurred, an asterisk (*) appears next
to the value which is out of specification. The corresponding error flag will be
printed in this field. Only those errors that FAIL the calibration will be printed.
• Value – Shows the value of the absorbance data which failed calibrator or
reaction limits.
• Magnitude – An indication of the severity of the failure. Depending on the
error, the magnitude may reflect the actual value of the error or it may show
the absolute difference between the limit and the actual value. Likewise, the
magnitude may not be applicable to the error which has occurred. If this is
the case, no value will appear under this field.
12-12
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Troubleshooting Calibration and Result Errors
Troubleshooting Result Errors
Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions (Continued)
Field
Description
Calibration Error Log
Error Flag
Magnitude
BLANK RATE
absolute delta
BLANK ABS
absolute delta
RXN RATE
absolute delta
RXN ABS
absolute delta
INIT ABS HI
actual value
INIT RATE HI
actual value
SPAN
absolute delta
All others
no magnitude
Troubleshooting Result Errors
Result Errors
Introduction
All reactions are checked against chemistry parameter flag limits (for example, absorbance limits,
reference ranges) to qualify the reagent, calibration, or sample. Checks are performed against the
final result and on interim reaction data for all samples, including calibrators. Any calibrator or
sample result or reaction step performing outside of any one or more limits will be flagged (message
or remark). A flagged sample value will not be reported.
Error Types and Description
Result Errors and Codes describe the errors or system conditions which affect chemistry results.
The conditions are described in Table 12.8 below.
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Troubleshooting Calibration and Result Errors
Error Codes and Definitions
Table 12.8 Error Type and Description
Error Type
Description
Error appeared in Result Column on
report
Indicates a result issue, result condition, or suppressed result.
Error condition appeared in Remarks
column on report
Indicates the reason for suppressed results or a condition
associated with the result, like reference ranges.
Host Code
Host codes are transmitted to the host with the result in question.
These codes may be translated by the host into error messages to
be printed with the host report. These codes are not printed on the
report.
Instrument Code
Instrument Codes are coupled with a chemistry code and indicate a
condition tied to a specific chemistry. These codes are printed on
the report in the Instrument Code section.
Example:
01AC translates to Sodium (01A) Calibration Overridden (C).
Some of these conditions will prevent the printing of a result.
IMPORTANT These codes are not located or transmitted
anywhere other than the Instrument Code field on the DxC
printed report.
Error Codes and Definitions
Result Errors and Codes
Result errors and codes are printed on the report. Table 12.9 below provides descriptions of those
codes.
Table 12.9 Result Errors and Codes
Result Displayed on Report
Printed in
Remarks Area
Host
Code
Inst.
Code
Description
"Result Printed"
D
Reagent Days exceeded
"Result Printed"
C
Calibration overridden
"Result Printed"
E
Calibration time extended
"Result Printed"
J
Slope offset adjustment
"Result Printed"
M
Set point modification
"Result Printed"
R
Reagent Expired
"Result Printed"
V
Rerun result
"Result Printed"
O
ORDAC result
"Result Printed"
P
Default Panel
"Result Printed"
12-14
OK
Calculation completed
A13914AF
Troubleshooting Calibration and Result Errors
Error Codes and Definitions
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report
Printed in
Remarks Area
Host
Code
Inst.
Code
Description
"Result Printed"
CRITICAL HIGH
Exceeds Critical range high
"Result Printed"
CRITICAL LOW
Exceeds Critical range low
"Result Printed"
HIGH
Exceeds reference range high
"Result Printed"
LOW
Exceeds reference range low
"Result Printed"
TEMP ERR
TM
T
Temperature error
<X (X=lower inst range)
LT
Less than X - OIR LO
<X (X=lower reportable range)
LT
Less than X - ORR LO
>Y (Y=upper inst range)
GT
Greater than Y - OIR HI
>Y (Y=upper reportable range)
GT
Greater than Y - ORR HI
CAL FAILED
Calibration failed
CAL TIMED OUT
Calibration timed out
CHEM ABORTED
Too many retries
CHEM BYPASSED
Channel bypassed
CHEM NEEDS CAL
Chemistry needs calibration
CHEM NOT RUN
Chemistry not run
DAC ERROR
ISE DAC Failure
DIL1 LEV SENSE
Level sense error in diluent cartridge
DIVISION ERROR
ZD
HI REAGENT
INCOMPLETE
Division Error Special calculation divisor is
zero
MC reagent level high
AB
Calculation incomplete
INSUFF DIL1
Insufficient diluent reagent for scheduled
tests
INSUFF REAG
Insufficient reagent strength
INVALID CHEM
Invalid chemistry
LEV SENSE ERR
Low reagent fluid
LO REAGENT
MC reagent level low
MOTION ERR
Motion error
NO DIL1 ON SYS
No diluent reagent on the reagent carousel
NO REAG ON SYS
Reagent not on board
NO SAMP DETECT
Low sample fluid
NO SAMP ON SYS
Sample not on board
NOT ACCEPTED
Wrong state for sample program message
PENDING TEST
Not ready
PROBE OBSTRUCT
Probe obstruction detected
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Troubleshooting Calibration and Result Errors
Error Codes and Definitions
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report
Printed in
Remarks Area
Host
Code
Inst.
Code
Description
RACK CONFLICT
HDLC/IBCT/HbA1c sample in wrong rack,
test cancelled
RESULT ERROR
Result error
Results Suppressed
AG EXCESS
AX
Antigen excess
Results Suppressed
BL ABS HI
BH
Blank absorbance high
Results Suppressed
BL ABS LO
BL
Blank absorbance low
Results Suppressed
BL MAX DEV
BO
Blank outlier (maximum deviation)
Results Suppressed
BL MEAN DEV
BN
Blank noise (mean deviation)
Results Suppressed
BL RATE HI
SH
Blank rate high
Results Suppressed
BL RATE LO
SL
Blank rate low
Results Suppressed
CAL REF DRIFT
EC
Excessive reference drift – sample to
calibration
Results Suppressed
INIT ABS HI
AH
Initial absorbance too high
Results Suppressed
INIT ABS LO
AL
Initial absorbance too low
Results Suppressed
INIT RATE HI
IR
Initial rate too high
Results Suppressed
INIT RATE LO
IL
CC chemistries, initial rate too low
MC chemistries, a stirrer failure
Results Suppressed
INIT ADC HI
HI
Initial ADC error high
Results Suppressed
INIT ADC LO
LI
Initial ADC error low
Results Suppressed
INIT COND HI
CH
Initial conductance high
Results Suppressed
INIT COND LO
CL
Initial conductance low
Results Suppressed
K REQ
IK
Bad K value
Results Suppressed
NA/K REQ
IN
Bad NA value
Results Suppressed
OIR HI
DH
Out of instrument range high
Results Suppressed
OIR LO
DL
Out of instrument range low
Results Suppressed
ORDAC HI
OH
Out of instrument range ORDAC high
Results Suppressed
ORDAC LO
OL
Out of instrument range ORDAC low
Results Suppressed
URDAC HI
GH
Under range URDAC high
Results Suppressed
URDAC LO
GL
Under range URDAC low
Results Suppressed
ORR HI
UH
Out of reportable range high
Results Suppressed
ORR LO
UL
Out of reportable range low
Results Suppressed
ORR O HI
UO
Out of ORDAC reportable range high
Results Suppressed
OVERFLOW
OF
Number overflow error
Results Suppressed
REF NOISE
DR
Reference signal noise (ISE only)
Results Suppressed
RX ABS HI
HR
Reaction absorbance high.
Results Suppressed
RX ABS LO
LR
Reaction absorbance low
12-16
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Troubleshooting Calibration and Result Errors
Error Code – Definitions
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report
Printed in
Remarks Area
Host
Code
Inst.
Code
Results Suppressed
RX ERR
RE
Reaction error
Results Suppressed
RX MAX DEV
RO
Reaction outlier (maximum deviation)
Results Suppressed
RX MEAN DEV
RN
Reaction noise (mean deviation)
Results Suppressed
RX NOISE
EA
Results Suppressed
RXN RATE HI
RH
Reaction rate high
Results Suppressed
RXN RATE LO
RL
Reaction rate low
Results Suppressed
SAMP NOISE
DS
Sample signal noise (ISE only)
Results Suppressed
SAMP REF DRIFT
ES
Excessive reference drift – sample to
sample
Results Suppressed
SUB DEPL
SD
Substrate depleted
Results Suppressed
TEMP ERR
TM
Results Suppressed
MOTOR ERR
HW
A
T
Description
Erratic ADC (Cup Chems only)
Temperature error (MC only)
Stirrer Motor Error
TEST STOPPED
Test was aborted, system issue
TOO MANY TESTS
Too many tests on CC
Error Code – Definitions
Antigen Excess — A chemistry failed antigen excess test for immunoprotein reagents. This flag may
indicate a contaminated cartridge.
Bad K/NA Value — K or NA are required to calculate a CALC result. Should one or the other fail or have an
error, CALC cannot be calculated and this error is reported. Check your K and NA values for any error
conditions.
K is required to calculate a urine NA result. If K value has an error, urine NA cannot be calculated.
Blank Absorbance High/Low — The mean absorbance measured during the reagent blank spin cycle
(read window) exceeds expected limits. The units are measured in absorbance and will characterize
reagent quality. This flag may indicate an issue with the reagent cartridge, reaction cuvette cleanliness or
sample integrity if chemistry is sample blanked.
Blank Noise (Mean Deviation) — The average difference between the absorbance readings and the line
of regression is greater than allowed. This is a check for a constant rate during the blank spin cycle. The
flag may indicate possible issues with a photometer reading.
Blank Outlier (Maximum Deviation) — A single blank absorbance data point obtained during the reagent
blank read window deviates more than allowed from the line of regression. The units are measured in
delta absorbance. Blank Maximum Deviation is a check for a constant rate during the blank spin cycles.
This flag may indicate possible issues with a photometer reading.
Blank Rate High/Low — Rate measured during blank timing period is not within specifications. Units are
measured in delta absorbance/minute. This flag may indicate an issue with reagent contamination,
reaction cuvette cleanliness or sample integrity.
A13914AF
12-17
12
Troubleshooting Calibration and Result Errors
Error Code – Definitions
Calculation Complete — Special Calculation was calculated with no result errors.
Calculation Incomplete — Not all tests required for the special calculation have valid results. Check results
for the tests in question and rerun if necessary.
Calibration Failed — Calibration was scheduled but failed one or more acceptance limits.
Calibration Overridden — Chemistry result was calculated with an overridden calibration value. The
calibration should be verified as valid before reporting the result.
Calibration Time Extended — Chemistry result was calculated with a calibration value from an expired
calibration which had been extended. The calibration should be verified as valid before reporting the
result.
Calibration Timed Out — Calibration expired before system could run this chemistry. Results are
incomplete. The reagent must be calibrated and the sample reloaded.
Channel Bypassed — Chemistry has been bypassed by special request of the operator.
Chemistry Needs Calibration — Chemistry requires calibration before proceeding with the requested
tests.
Chemistry Not Run — Chemistry not run for non-specified reason. Reload sample and attempt to run
again.
Division Error — Special Calculation had a zero (0) result in the denominator of the calculation. Check
results for the test in question and rerun test if necessary.
Erratic ADCs — The erratic ADC flag is an indication of MC cup noise. Noise is determined differently within
each cup, dependent on each type of reaction.
TPm and PHOSm noise is evaluated by determining the standard estimate of the error divided by rate for
the rate ADC readings.
ALBm noise is determined by evaluating the maximum deviation between the four ADC readings for both
reference and sample plus reference readings.
GLUCm and BUNm/UREAm noise is evaluated using multiple rate readings used to determine the final
result by screening these values for indication of noise.
Exceeds Critical Range Low/High — Result exceeds operator defined critical ranges in reference range
setup. Please refer to Reference/Critical Ranges Setup in CHAPTER 3, System Setup Options in this manual
for additional information.
Exceeds Reference Range Low/High — Result exceeds operator defined reference ranges in reference
range setup. Please refer to Reportable Ranges Setup in CHAPTER 3, System Setup Options in this manual
for additional information.
Excessive Reference Drift – Sample to Calibration — The reference value for an ISE sample
measurement drifted from the reference value of the calibration and exceeded the limit. The units are
measured in ADCs and are a measurement of ISE sample electrode drift.
This flag may be triggered for CL, K, NA and CALC by excessive ambient room temperature shifts. CL may
also experience this flag when running many urine samples or needs maintenance. Correct CL electrode
by running serum samples to recondition the electrode.
K and CALC may see this error when electrode is newly installed. Refer to CHAPTER 9, Maintenance in this
manual for additional information.
A faulty calcium electrode MAY also cause sample reference drift errors on sodium and potassium results.
12-18
A13914AF
Troubleshooting Calibration and Result Errors
Error Code – Definitions
Excessive Reference Drift – Sample to Sample — The reference ADC value for a sample drifted above
the acceptable difference between consecutive samples. The units are measured in ADCs and are a
measurement of reference reagent readings by sample electrode. This measures the ability of the sample
electrode to recover between samples.
This flag may be triggered for CL when running urine and serum samples together and is an indication of
CL electrode condition.
A faulty calcium electrode MAY also cause sample reference drift errors on sodium and potassium results.
Greater Than Y - OIR HI — Calculated result is greater than the Upper Instrument Printable Range. Result
is not reported.
Greater Than Y - ORR HI — Calculated result is greater than the Upper Reportable Range. Result is not
reported.
Initial Absorbance High/Low — The reaction absorbance data taken from the first spin cycle after sample
or trigger reagent inject has exceeded specifications. This is a measure of sample integrity and may
indicate a turbid or lipemic sample or in DAT chems, the presence of an interfering substance.
Initial ADC Error High/Low — The ADC value determined from the first read after reagent addition has
exceeded specifications. This is a measure of modular cup reagent or cup integrity.
This flag may be triggered if using old, contaminated or poorly prepared reagents, or when a cup
chemistry fails to empty properly, leaving a dirty reaction cup. This flag may also be triggered when
experiencing temperature differences either external or internal to the system.
Initial Conductance Error High/Low — The initial conductance readings for GLUCm or BUNm are below or
above acceptable limits. This may be caused by poor reagent preparation, poor electrode integrity or cup
heater issues.
Initial Rate High/Low — For CC chemistries, the reaction absorbance data obtained between 2 and 17
seconds after sample or the trigger reagent inject exceeds specifications. This flag is used to trigger auto
and manual ORDAC testing
For the MC chemistries GLUCm, BUNm/UREAm, TPm (not CSF) and ALBm, this flag indicates a failure in
the related stirrer mechanism.
Insufficient Diluent Reagent — The Diluent cartridge currently loaded on the system does not contain
adequate volume of reagent to perform all required on-board dilutions.
Insufficient Reagent Strength — GLUCm and BUNm/UREAm reagent conductivity is below specifications.
For GLUCm, this flag may indicate an issue with the glucose electrode. Replace electrode and continue
running. For BUNm/UREAm, this flag may indicate an electrode cleaning issue, contaminated or old
reagent, or possible valve errors.
Invalid Chemistry — System cannot find correct parameters to run the requested chemistry. Possible UDR
or Database error.
ISE DAC Failure — The electrode response observed during calibration exceeds the pre-defined ADC
range. This flag may indicate an issue with an electrode, analog board problems, or compromised
reference reagent.
Less Than X-OIR LO — Calculated result is less than the Lower Instrument Printable Range. Result is not
reported.
Less Than X-ORR LO — Calculated result is less than the Lower Reportable Range. Result is not reported.
A13914AF
12-19
12
Troubleshooting Calibration and Result Errors
Error Code – Definitions
Level Sense Error in Diluent Cartridge — A Level Sense Error occurred in the diluent cartridge and the
system was unable to perform the required dilutions. This error may affect Ig-G, Ig-M, Ig-A, and TRFN in
serum samples or MG, BUN, UREA, or URIC in urine mode. All of these tests perform on-board dilutions
before analysis.
Low Reagent Fluid — A Level Sense Error was obtained when attempting to run a specific cartridge.
Remove cartridge and check for bubbles and adequate reagent level. Remove bubbles, if present, and
reload. If system still receives a level sense error, refer to the UniCel DxC Synchron Clinical Systems
Reference Manual, CHAPTER 5, Advanced Troubleshooting, CC Hardware Symptoms for additional
investigation.
Low Sample Fluid — No sample detect.
MC Reagent Level High/Low — Reagent level detected with cup is either too high or too low.
A high flag may indicate issues with a blocked drain value, low vacuum or malfunctioning level sensing.
A low flag may indicate an empty reagent bottle or loose straw, bubbles in the reagent, pump failure,
disconnected reagent lines or valve failures. After the problem is solved, repeat the last two samples run
in that cup module.
Motion Error — Motion error occurred while system was performing requested test.
No Diluent on Reagent Carousel — The required diluent cartridge is not present on the system and the
requested tests cannot be performed.
Not Ready — The system is preparing to run the requested tests and the tests are Pending.
ORDAC Result — Result was calculated using ORDAC feature.
Out of Instrument Range High/Low — The recovered value exceeds the value that the instrument will
report.
Out of ORDAC Range High/Low — A reaction exceeded the range of ORDAC (Over Range Detection and
Correction) values that the instrument will report.
If a sample has an ORDAC LO message and Manual ORDAC is on, rerun the sample with manual ORDAC
off.
If a sample has an ORDAC LO message and Auto ORDAC is on:
1. Dilute the sample 1:2.
2. Program the sample as a 1:2 dilution.
3. Rerun the sample.
If the system gives an answer, report this result. If the result again gives an ORDAC LO, do a larger dilution
and rerun for the applicable dilution.
Out of ORDAC Reportable Range — Result exceeds the operator defined ORDAC range high. Refer to
Reportable Ranges Setup in CHAPTER 3, System Setup Options in this manual for additional information.
Out of Reportable Range High/Low — Result exceeds the operator defined reportable range high or low.
Refer to Reportable Ranges Setup in CHAPTER 3, System Setup Options in this manual for additional
information.
Probe Obstruction Detected — The system detected a block in the sampling system when sampling the
requested samples. Check affected samples for clots, then reload. If issue still persists, refer to the UniCel
DxC Synchron Clinical Systems Reference Manual, CHAPTER 5, Advanced Troubleshooting, CC Hardware
Symptoms or MC Hardware Symptoms for additional investigation.
12-20
A13914AF
Troubleshooting Calibration and Result Errors
Error Code – Definitions
Reaction Absorbance High/Low — The mean absorbance measured during the reaction spin cycles
exceeded limits. The units are measured in absorbance and will usually characterize sample integrity. If
a high flag is triggered, dilute the sample and rerun. If a low flag is triggered, rerun sample for verification,
except for TDMs. TDMs with low reaction absorbance flags should be diluted and rerun.
Reaction Noise (Mean Deviation) — The average difference between the reaction absorbance readings
and the line of regression is greater than allowed. This checks for constant noise during the spin cycle.
This flag may indicate possible issues with a photometer reading. Also, results below the low end of the
analytical range may trigger the RXN NOISE flag.
Reaction Outlier (Maximum Deviation) — A single reaction absorbance data point, obtained during the
reaction read window, deviates more than allowed from the line of regression. The units are measured in
delta absorbance and will check for noise during the reaction read window. This flag may also indicate
possible issues with a photometer reading.
Reaction Rate High/Low — The rate calculated during the reaction read window exceeds reaction rate
limits. Units are measured in delta absorbance/minute. If a high flag is triggered, dilute the sample and
rerun. If a low flag is triggered, rerun sample for verification. The low flag may also indicate an old or
contaminated reagent cartridge.
It is not appropriate to report a result of ">" or "<" the analytical range of the analyte for this error code.
Reagent Days Exceeded — On-board reagent has exceeded the usable days. The result should be verified
as acceptable before reporting the value.
Reagent Expired — On-board reagent has exceeded its Lot Expiration Date. The result should be verified
as acceptable before reporting the value.
Reagent Not on Board — Tests could not be run as programmed; reagent was not loaded on the system.
Reference Signal Noise — The difference between the high and low values of the eight reference readings
(taken milliseconds apart) has exceeded the limits allowed. Units are measured in ADCs and are a
measurement of the ISE reference electrode noise observed during the reference cycle. Consistent flags
may indicate poor system grounding. Other causes include bubbles in reagent, pinched lines, or anything
which may interrupt reference reagent flow.
Rerun Result — Test result is a rerun result.
Result Error — This error occurs when a result does not fit into a specific calibration curve. Rerun the
sample for verification. This error may indicate sample interference issues. It may also indicate issues
with photometer performance. Contact Beckman Coulter Support Center for additional information.
Sample in Wrong Rack — The requested tests have been programmed in the wrong rack when preprogrammed reserved racks have been specified for requested tests. Refer to Reserved Racks/Obstruct
Detect in CHAPTER 3, System Setup Options in this manual for additional information on reserved racks.
Sample Signal Noise — The difference between the high and low values of the eight sample readings has
exceeded the limits allowed. Units are measured in ADCs and are a measurement of system noise
observed during the sample cycle. Consistent flags may indicate poor system grounding.
Set Point Modification — The calibration being used for this specific result was performed with adjusted
set point values. The test result associated with this Result Error code is directly affected by these
calibration adjustments. Refer to System Calibration in CHAPTER 4, Reagent Load/Calibration in this
manual for additional information.
A13914AF
12-21
12
Troubleshooting Calibration and Result Errors
Error Code – Definitions
Slope Offset Adjustment — The test result associated with this Result Error code was calculated with a
modified calibration. Slope and/or Offset were modified and the result was directly affected by these
calibratrion adjustments. Refer to Slope Offset Adjustment in CHAPTER 4, Reagent Load/Calibration in this
manual for additional information
Substrate Depletion — The difference (delta) between the initial absorbance taken after sample or trigger
reagent inject and the final absorbance data within the reaction read window exceeds specifications.
Rerun sample with ORDAC enabled (if appropriate) or dilute sample and rerun..
Temperature — The operating temperature of the system is beyond 0.1°C from the set point value. All
cartridge chemistries will be reported with a flag.
Test Aborted — Scheduled test has been aborted for non-specified reason. This usually occurs when a
system error compromises chemistry testing or sytem has been stopped while running.
Under Range Detection and Correction (URDAC) High/Low — A reaction exceeded the range of URDAC
values that the instrument will report.
12-22
A13914AF
A13914AF
Common Error Messages and Corrective Actions
Table 12.10 shows the most common system error messages in numerical sequence. It also shows the text that appears on the pop-up window
that appears when the error occurs, the accompanying text that will be inserted into the Event Log, a description of the probable cause for the
error and the recommended corrective action to take to resolve the problem.
Online Help is available for troubleshooting common error messages. On the DxC console, error messages contain links to the Online manuals.
Select the Help icon next to the event number to display specific information about the error. A grey Help icon indicates that the Instructions For
Use manual is not loaded. For error messages that do not have a Help icon next to the event number, refer to the UniCel DxC Synchron Clinical
Systems Reference Manual for troubleshooting information.
Online Manual Links
The system may display an “Error -- The page cannot be displayed” pop-up message when you select the Event ID button to link to the online
manual from an instrument pop-up error message, or when you select a link in the online manual. To continue, record the Event ID, select OK
from the Error pop-up message and then use the search feature of the online manual to find the topic you were seeking.
NOTE To view the instrument pop-up error Event ID number, use the ( ALT ) + ( F1 ) key combination to return to the instrument screen.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-1
Tr
ID
Class #
0x01F80019
5
0x01F90005
3
Pop-up
Event Log
Cup positions were out
of order. Repeat
procedure starting with
position 1 which is
outermost.
CAU: Align - Sample rack
positions are in reversed order
Reagent Carousel
Temperature Error.
Reagent Stability may
be compromised.
CAU: Reagent Carousel
Temperature Error. Reagent
Stability may become
compromised
Description
Corrective Action
Wrong order used for rack positions
while performing alignment.
• Redo the alignment. Make sure the correct
positions are used (position 1 is on the outside of
the sample carousel).
Sensor indicates the air temperature
within the reagent carousel is out of
range (+2.0°C to +8.0°C).
Intermittent message may be caused by:
• recent loss of power
• system reboot or
• reagent door being open too long
Message ID: 0x01F80019
Message ID: 0x01F90005
No operator action is necessary.
Subsystem: PWRMGR
Consistent messages may indicate issues with the:
• Thermister
• Thermister cable
• Power Control Board
• Peltier Assembly
Temperature:
Contact Beckman Coulter Support Center for
additional information.
0x01F90084
4
Power Smart Module
Communication Error
CAU: SMC Receive Error
Message ID: 0x01F90084
Subsystem: PWRMGR
A communication error has occurred
between the Power Distribution Board
(Smart Module 21) and the Instrument
Computer System (ICS).
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
Whenever the DI water reservoir does
not fill within its given amount of time, it
will time out and flag that it has not filled.
• Make sure DI water is turned on at the source.
• Make sure the manual water inlet valve is
turned on.
• Make sure the instrument has not rolled on top
of the water inlet lines.
• Home and restart the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
Msg Size: number of bytes
0x01FA0003
4
DI water reservoir is not CAU: DI water reservoir is not
filling at all
filling at all
Message ID: 0x01FA0003
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-2
Table 12.10 Error Messages and Corrective Actions
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
0x01FA0004
4
Flood In Waste
Collection Sump.
Switch #11
CAU: Flood In Waste Sump
0x01FA0006
4
Flood In Primary
Vacuum Accumulator.
Switch #22
CAU: Flood In Primary Vacuum
Accumulator
Waste Exit Sump Is Not
Draining At All
CAU: Waste Exit Sump Is Not
Draining At All
0x01FA0008
4
Message ID: 0x01FA0004
Message ID: 0x01FA0006
Message ID: 0x01FA0008
Description
Corrective Action
This error occurs when the waste
collection sump float switch indicates
that the canister is full, which is
considered a flood for this canister.
• Check the waste collection sump canister for
liquid. Empty if necessary.
• Press the STOP button and Home the system.
• Contact Beckman Coulter Support Center for
additional information.
This error will occur when the Vacuum
Accumulator Float Switch indicates that
the canister is full/flooded. This is a
safety mechanism that prevents a flood
from getting into the pumps. The
Vacuum accumulator should never have
any fluid in it and should be emptied
whenever fluid is found during
Maintenance.
• Check the vacuum accumulator canister for
liquid. Empty if necessary.
• Press the STOP button and Home the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
This error will flag when the Waste Exit
Sump does not drain within the given
drain time for the sump.
• Make sure Drain Line is not clogged or pinched.
• Make sure Instrument is not rolled on top of the
Drain Line.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-3
12
ID
Class #
0x01FA0009
4
Pop-up
Event Log
DI Water Canister Is Not CAU: DI Water Canister Is Not
Filling At All
Filling At All
Message ID: 0x01FA0009
Description
Corrective Action
Whenever the DI water canister does not
fill within its given amount of time, it will
time out and flag that it has not filled.
• Make sure DI water is turned on at the source
and present in the DI Water Reservoir.
• If Reservoir is full,
— Press the STOP button and Home the
system.
— If the error continues, contact Beckman
Coulter Support Center for additional
information.
• If Reservoir is empty,
— Make sure the Manual water inlet valve is
turned on.
— Make sure the instrument has not rolled on
top of the water inlet lines.
— Home and restart the system.
— If the error continues, contact Beckman
Coulter Support Center for additional
information.
0x01FA000B
4
0x01FA0014
4
0x01FA0015
4
A13914AF
Wash Concentrate
Reservoir Is Not Filling
At All
CAU: Wash Concentrate
Reservoir Is Not Filling At All
Wash Concentrate Reservoir Is Not Filling
At All.
• Load a new bottle of Wash Concentrate. Refer to
Load/Unload Modular Chemistries (MC).
Both The Waste B Exit
Sump And The
Collection Bottle Are
Full. Switch #29,15,9.
CAU: Both The Waste B Sump
And The Collection Bottle Are
Full
Both The Waste B Sump And The
Collection Bottle Are Full. Only applies to
systems configured with the Split Waste
Option.
• Empty the external waste B collection bottle and
Resume Waste B.
External Waste B
Collection Bottle Is Full.
Switch #29. Waste B
Paused. Replace Waste
B Container and select
Resume in Instrument
Commands when
ready.
CAU: External Waste B Bottle Is The Waste B Container is Full. Only
Full
applies to systems configured with the
Split Waste Option.
Message ID: 0x01FA0015
Message ID: 0x01FA000B
Message ID: 0x01FA0014
• Empty the external waste B collection bottle and
Resume Waste B.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-4
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
0x01FA0016
4
Primary vacuum level is CAU: Primary vacuum is low
low.
Message ID: 0x01FA0016
0x01FA0019
4
10 psi Air Supply
Pressure Is Low.
Description
Corrective Action
This error occurs when the Primary
vacuum drops below 18 in Hg for more
than 15 seconds. There is no vacuum
level adjustment now and cannot be set.
• Check vacuum levels and Home the system.
• Make sure No Foam is present, replace if
necessary. Refer to Load/Unload Modular
Chemistries (MC).
• Make sure caps on pressurized bottles are tight.
• Make sure Vacuum Accumulator canister in the
rear of the Hydro is empty.
• Contact Beckman Coulter Support Center for
additional information.
CAU: 10 psi Air Pressure Is Low This error occurs when the transducer
line #129 is outputting a value into the
Message ID: 0x01FA0019
Hydro Board that is below the 10 psi
specification.
• Check pressure levels and Home the system.
• Adjust pressure levels if necessary as follows:
— Adjust pressure in Main system above 17
psi.
— Adjust the high pressure system to 17 psi.
— Adjust the low pressure system. The
pressure range for the low pressure system
is 8–11 psi. Set it at 10 psi.
12-5
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
• Contact Beckman Coulter Support Center for
additional information.
12
ID
Class #
0x01FA001A
4
Pop-up
10 psi Air Supply
Pressure Is High
Event Log
Description
CAU: 10 psi Air Pressure Is High This error occurs when the transducer
line #129 is outputting a value into the
Message ID: 0x01FA001A
Hydro Board that is above the 10 psi
specification.
Corrective Action
• Check pressure levels and Home the system.
• Adjust pressure levels if necessary as follows:
— Make sure the 25 psi (Main Pressure) gauge
on the hydro reads within 24 to28 psi.
— Adjust the 25 psi (Main Pressure) regulator
as necessary.
— When the 25 psi pressure is within range,
make sure the High Pressure reading on the
Hydro Status screen is 17 ± 1.
— Adjust the low pressure system. The
pressure range for the low pressure system
is 8–11 psi. Set it at 10 psi.
• Contact Beckman Coulter Support Center for
additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-6
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
0x01FA001B
4
17 psi air supply
pressure is low
Event Log
Description
CAU: 17 psi Air Pressure is Low This error will occur whenever there is a
problem within the high-pressure
Message ID: 0x01FA001B
system. If the high pressure reads lower
than 14 psi for more than 15 seconds it
will be flagged as low.
Corrective Action
• Home the system.
• If the instrument returns to Standby, adjust
pressure levels if necessary as follows:
— Make sure the 25 psi (Main Pressure) gauge
on the hydro reads within 24 to28 psi.
— Adjust the 25 psi (Main Pressure) regulator
as necessary.
— When the 25 psi pressure is within range,
make sure the High Pressure reading on the
Hydro Status screen is 17 ± 1.
— Adjust the 17 psi (High Pressure) regulator
as necessary.
— When the 17 psi pressure is within range,
make sure the Low Pressure reading on the
Hydro Status screen is within range.
— Adjust the 10 psi (Low Pressure) regulator as
necessary.
0x01FA001C
4
17 psi air supply
pressure is high
CAU: 17 psi air pressure is high This error will occur whenever there is a
problem within the high-pressure
Message ID: 0x01FA001C
system. If the High pressure reads
higher than 19 psi for more than 15
seconds it will be flagged as "High."
• Check pressure levels and Home the system.
• Adjust pressure levels if necessary as follows:
— Make sure the 25 psi (Main Pressure) gauge
on the hydro reads within 24 to28 psi.
— Adjust the 25 psi (Main Pressure) regulator
as necessary.
— When the 25 psi pressure is within range,
make sure the High Pressure reading on the
Hydro Status screen is 17 ± 1.
— Adjust the high pressure system to 17 psi.
12-7
• Contact Beckman Coulter Support Center for
additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
• If the instrument will not return to Standby,
contact Beckman Coulter Support Center for
additional information.
12
ID
Class #
0x01FA002B
4
Pop-up
Hydro Smart Module
Communication
Problem. Stop/Home
may resolve this issue.
Event Log
Description
Corrective Action
System stopped. Communication issue
with hydro smart module.
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
Float Switch sending full and empty
messages at the same time.
• Unscrew the canister. Wipe the float switch and
make sure the float is not stuck.
• Replace the Float Switch in the specified
container.
Likely cause is the Instrument computer
has attempted to access a restricted
area or file.
• At the Red Message screen, select Shutdown.
• If the problem continues contact Beckman
Coulter Support Center for additional
information.
Likely cause is the Instrument computer
has received an invalid or unexpected
response. This is not caused by user
input.
• At the Red Message screen, select Shutdown.
• If the problem continues contact Beckman
Coulter Support Center for additional
information.
CAU: CC Sample Probe
Disabled Due To Level Sense
Errors
Five consecutive sample level sense
errors – probe, bead, bad alignment or
level sense board problem.
Message ID: 0x0262000F
System Response = Pause RA.
• Make sure Samples are in the correct rack.
• Perform CC Sample Probe to Cup and CC Sample
Probe Height alignments. Refer to step 3 of the
Replace the Old Probe procedure.
• Perform CC Sample Probe Level Sense
Alignment (Calibration).
CAU: Hydro SM not
communicating with MSMC.
Check fiber optics
communication loop
Message ID: 0x01FA002B
0x01FA0034
4
Hydro Illegal Switch
Condition
CAU: Hydro Illegal Switch
Condition
Message ID: 0x01FA0034
Container: container
0x025C0001
4
Instrument Computer
Error
CAU: Debug port abort
Message ID: 0x025C0001
Subsystem: CAU
Problem Area: problem area
0x025C0009
4
Instrument Computer
Error
CAU: Bus Error
Message ID: 0x025C0009
Subsystem: CAU
Task Name: task name
Vector ID: vector id
0x0262000F
4
CC Sample Probe
Disabled Due To Level
Sense Errors
Subsystem: RASched
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-8
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x02620012
4
0x02620017
2
Pop-up
Event Log
CC Reagent Cartridge –
No Fluid Detected
CAU: CC Reagent Cartridge No
Fluid Detected
Chemistry Name:
chemistry name
Message ID: 0x02620012
Reagent Position:
reagent position
Chemistry Name:
Component:
component
Component:
Description
Corrective Action
Two consecutive reagent level sense
errors for same cartridge – cartridge is
unusable.
• Remove bubbles from cartridge neck or floating
on reagent surface.
• Reload reagent cartridge.
Refer to Load/Unload Cartridge Chemistries
(CC).
This error will occur with any type of
motion error within the Reaction Wheel.
• Raise canopy and check for obvious obstruction
of the Reaction Wheel.
• Make sure sample and Reagent Mixer paddles
are properly seated.
• Make sure Wash Tower is properly seated and
aligned to cuvettes.
• Press the STOP button and Home the system.
• Contact Beckman Coulter Support Center for
additional information.
Subsystem: RASched
Reagent Position:
CC Reaction Wheel
CAU: CC Reaction Wheel
Subsystem Motion Error Subsystem Motion Error
Message ID: 0x02620017
Subsystem: RASched
Action Name: action name
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-9
12
ID
Class #
0x02620018
2
Pop-up
CC Reagent Delivery
Subsystem Motion
Error, Pausing
Event Log
CAU: CC Reagent Delivery
Subsystem Motion Error,
Pausing
Message ID: 0x02620018
Subsystem: RaSched
Description
Corrective Action
This occurs after 2 motion errors on the
Reagent Delivery Subsystem.
• When the instrument goes to Stopped state,
check for possible interference with the motion
of the reagent probes, reagent mixer or reagent
syringe drive.
• Make sure the reagent drip tray is installed
properly.
• Make sure the reaction carousel evaporation
cover is installed properly.
• Check the reagent syringe to make sure the
plunger is seated correctly.
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• While the system Homes, check for possible
interference issues.
• If the system Homes successfully, restart the
run and check the reagent probes and mixer for
possible interferences (e.g., improper cable
routing or not in alignment).
The CC side of the system is placed into
Pausing then Stopped state.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-10
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x02620019
2
Pop-up
CC Sample Delivery
Subsystem Motion
Error, Pausing
Event Log
CAU: CC Sample Delivery
Subsystem Motion Error,
Pausing
Message ID: 0x02620019
Subsystem: ccScheduler
CC Sample Probe
Obstruction
CAU: CC Sample Probe
Obstruction
Sample ID:
Message ID: 0x0262001A
Rack ID:
Subsystem: RASched
Rack Position:
Sample ID:
This occurs on first
attempt
Rack ID:
Rack Position:
Sample Error Count:
Probe Error Count:
Cycle Number:
Corrective Action
This occurs after two motion errors on
the Sample Delivery Subsystem. Level
Sense errors will not trigger this error.
The system goes into Pausing and then
Stopped state.
• Raise canopy and check for obvious obstruction
of the sample probe or syringe.
• Press the STOP button and Home the system.
While system is homing, observe motion of the
CC sample syringe and CC Sample probe. The
probe and syringe should complete their
operations in a smooth manner.
• If the error continues, check the event log to
determine if the syringe or probe is responsible
for the error.
• If the CC sample probe is responsible, perform
the appropriate vertical or horizontal alignment.
Refer to Step 3 in the Install the New Probe
procedure.
• If the Syringe is responsible, check for proper
seating of syringe assembly.
• Contact Beckman Coulter Support Center for
additional information.
This error occurs when the CC sample
probe ODC (Obstruction Detection &
Correction) indicates that the probe is
obstructed during sample aspiration.
• No operator action is necessary.
• The system will attempt a second aspiration
from this sample.
12-11
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x0262001A
4
Description
12
ID
Class #
Pop-up
0x0262001B
4
Unrecovered CC
Sample Probe
Obstruction
Event Log
Description
Corrective Action
CAU: Unrecovered CC Sample
Probe Obstruction
This error occurs when there was an
Obstruction present at the CC sample
probe. The probe tried to clear the
obstruction by flushing, but the
obstruction could not be removed. The
CC side of the system will finish any tests
that are in progress and then go to a
Stopped state.
• Flush the CC Sample probe per the "As Needed"
Flush the Sample and Reagent Probe procedure.
• If flushing probe is not successful, Replace the
Sample and Reagent Probe.
• If probe is clear and error continues, check for
pinched Sample line tubing.
• If the error continues contact Beckman Coulter
Support Center for additional information.
This error is caused by a Vertical or
Rotary motion error. This will cause the
instrument to go into a Stopped state.
• Raise canopy and check for obvious obstruction
of the CC reagent Probe A.
• Press the STOP button and Home the system.
While system is homing, observe motion of the
CC reagent probe A. The probe should complete
its operations in a smooth manner.
• If the error continues, check the event log to
determine the specific subsystem error. Refer to
Event Log.
• If event log indicates a vertical error, make sure
the reagent cartridges on the carousel are
pushed in and seated properly.
• Perform the appropriate vertical or horizontal
CC reagent Probe A alignment. Refer to step 3 in
the Install the New Probe procedure.
• Contact Beckman Coulter Support Center for
additional information.
Message ID: 0x0262001B
Subsystem: ccScheduler
0x0262001D
2
CC Reagent Probe A
Motion Error
CAU: CC Reagent Probe A
Motion Error
Message ID: 0x0262001D
Subsystem: RASched
Action Name: action name
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-12
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x0262001E
2
Pop-up
CC Reagent Probe B
Motion Error
Event Log
CAU: CC Reagent Probe B
Motion Error
Message ID: 0x0262001E
Corrective Action
This error is caused by a Vertical or
Rotary motion error. This will cause the
instrument to go into a Stopped state.
• Raise canopy and check for obvious obstruction
of the CC reagent Probe B.
• Press the STOP button and Home the system.
While system is homing, observe motion of the
CC reagent probe B. The probe should complete
its operations in a smooth manner.
• If the error continues, check the event log to
determine the specific subsystem error. Refer to
Event Log.
• If event log indicates a vertical error, check that
the reagent cartridges on the carousel are
pushed in and seated properly.
• Perform the appropriate vertical or horizontal
CC reagent Probe B alignment. Refer to Event
Log.
• Contact Beckman Coulter Support Center for
additional information.
This error occurs when there is an error
within the CC Reagent Syringe
Subsystem. This includes both the Shear
valve Motor and the Lead Screw Motor.
• Raise canopy and check for proper seating of
syringe assembly.
• Press the STOP button and Home the system.
While system is homing, observe motion of the
CC reagent syringe. The syringe should
complete its operations in a smooth manner.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
This error will occur whenever there is a
motion error in the Reagent Switch (A/B
valve). This error does not occur during a
home, only runtime, primes, etc.
• Press the STOP button and Home the system.
• Contact Beckman Coulter Support Center for
additional information.
Subsystem: RASched
Action Name: action name
0x02620020
2
CC Reagent Syringe
Motion Error
CAU: CC Reagent Syringe
Motion Error
Message ID: 0x02620020
Subsystem: RASched
Action Name: action name
0x02620021
2
CC Reagent Switch
Motion Error
CAU: CC Reagent Switch
Motion Error
Message ID: 0x02620021
Subsystem: RASched
Action:
12-13
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
Description
12
ID
Class #
0x02620022
2
Pop-up
CC Reagent Wheel
Motion Error
Event Log
CAU: CC Reagent Wheel
Motion Error
Message ID: 0x02620022
Description
The CC Reagent wheel observed a
motion error. The wheel itself may be
obstructed.
• Shutdown the instrument. Refer to Shutdown.
• When the DxC is turned off, manually unlatch
the CC Reagent Compartment door. The latch is
located below the CC reagent compartment
door and above the instrument power switch.
Slide the latch to the left to open the
compartment door.
• At this time, the reagent carousel can be
manually rotated, if necessary, to clear a
jammed cartridge.
• Close CC Reagent compartment door.
• Power the instrument back up. Refer to System
Power On/Boot.
• If the problem continues, contact Beckman
Coulter Support Center for additional
information.
This error occurs when there is a motion
error within the Sample mixer crane.
These errors will occur while in Standby,
Priming, or during runtime. This error will
not pop up during a home. This can be a
rotary or vertical motion error.
• Make sure mixer has the necessary room to
move.
• Make sure the wiring and cabling are secured
properly.
• Make sure mixer paddle is seated firmly in its
housing.
• Home the system.
• If mixer appears out of position, perform rotary
or vertical alignment.
• If motion error continues, contact Beckman
Coulter Support Center for additional
information.
Subsystem: RASched
Action Name: action name
0x02620024
2
CC Sample Mixer
Motion Error
CAU: CC Sample Mixer Motion
Error
Message ID: 0x02620024
Subsystem: RASched
Action:
Corrective Action
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-14
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x02620025
2
Pop-up
CC Sample Syringe
Motion Error
Event Log
CAU: CC Sample Syringe
Motion Error
Message ID: 0x02620025
Subsystem: RASched
Description
Corrective Action
This error occurs when there is an error
within the Sample Syringe Subsystem.
This includes both the Shear valve Motor
and the Lead Screw Motor.
• Make sure syringe and plunger are properly
seated at top and base of syringe.
• Check for obstruction of syringe movement.
• Perform CC Syringe Home Alignment.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
This error can be flagged for the
following:
• Remove wash station head and inspect probes
for blockage and wiper for wear. Refer to
Replace Cuvette Wiper for removal of Wash
Station.
• Check wash station wiper alignment.
• Check wash station alignment.
• Remove reaction carousel and check cuvette
cleanliness.
Action Name: action name
0x02620033
4
10 Cuvettes Have failed CAU: 10 Cuvettes Have Failed
Water Blank
Water Blank
Message ID: 0x02620033
Subsystem: RaSched
CC Reagent probe
disabled due to level
sense errors
CAU: CC Reagent Probe
Disabled Due To level Sense
Errors
Message ID: 0x02620034
Subsystem: RASched
Probe: probe
Multiple reagent cartridges have level
sense errors.
Non-resolution of problem may indicate photometer
issues. Contact Beckman Coulter Support Center for
additional information.
• Home the system.
• Check reagent cartridges for bubbles.
• Perform Reagent Probe to Cartridge and
Reagent Probe Height in Cartridge Alignments.
Refer to step 3 of the Replace the Old Probe
procedure.
12-15
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x02620034
4
• A cuvette's wavelength absorbance
is over 350 mA (Absorbance) for all
wavelengths between 340 to 700
nanometers.
• A cuvette's wavelength absorbance
is over 200 mA (Absorbance) for the
940 nanometer wavelength (PRO
System only).
• PSM Error.
• LPIA Failure.
12
ID
Class #
0x02620036
4
Pop-up
Event Log
Level sense error in one CAU: Level sense error in one
or more cartridges
or more cartridges
Message ID: 0x02620036
Subsystem: RASched
Description
Corrective Action
This error occurs when the reagent
probes were unable to detect fluid in a
selected cartridge or cartridges during a
reagent load. One attempt by each A
and B reagent probe is made to level
sense and resulting levels are then
compared for accuracy/consistency.
• Unload the reagent cartridge and inspect to see
if there are any bubbles in the cartridge
compartments, or residual fluid on the sidewalls
of the openings of the cartridge compartments.
This could cause false triggering of the level
sense. Refer to Load/Unload Cartridge
Chemistries (CC).
• Cartridge must be reloaded to initiate level
sense.
• Check reagent probe alignment for any residual
fluid in wash collar.
Consistent messages may indicate issues with the
level sense function of:
• reagent probe bead assembly
• reagent probe alignments
• level sense board
Contact Beckman Coulter Support Center for
additional information.
0x0262003A
4
CC Sample Probe
disabled due to
obstruction errors
CAU: CC Sample Probe
Disabled Due To Obstruction
Errors
Multiple samples had Obstructions
(Clots).
Message ID: 0x0262003A
Subsystem: ccScheduler
0x0262003F
4
Too many tubes not
venting correctly,
sampling for the CC
probe will be stopped
CAU: CC Sample Probe
Multiple tubes had excessive vacuum in
disabled due to Excess Vacuum thick stopper closed tubes. CC Sample
Errors
Probe Disabled.
Message ID: 0x0262003F
A13914AF
Subsystem: ccScheduler
• Try flushing probe from the top. Refer to Flush
the Sample and Reagent Probe.
• Perform the CC Sample Probe Alignment
(Calibration). Refer to Step 3 of the Replace the
Sample and Reagent Probe procedure.
• Replace probe. Refer to Step 3 of the Replace
the Sample and Reagent Probe procedure.
• Check cap piercer for broken blade. Refer to
Replace CTS Blade/Wick (1-Blade Thick CTS
Option) or Replace CTS Blade (1-Blade Narrow
CTS Option) to inspect the blade.
• Perform CC ODC Alignment.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-16
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x02620040
4
Pop-up
Corrective Action
Multiple tubes had excessive pressure in
thick stopper closed tubes. CC Sample
Probe Disabled.
• Check cap piercer for broken blade. Refer to
Replace CTS Blade/Wick (1-Blade Thick CTS
Option) or Replace CTS Blade (1-Blade Narrow
CTS Option) to inspect the blade.
• Perform CC ODC Alignment.
Likely cause is an obstruction in the
sample rack handler. Current In-Process
samples will continue until finished. No
more samples will be loaded.
• When instrument goes to Stopped state, press
the DxC STOP button. Wait for the motors to
release power (about 30 seconds, listen for the
sound of the Smart Modules resetting) then
Home the system.
• Check for any obstructions in the sample rack
handler and clear any obstruction found.
• Home the system.
• Reload any incomplete racks.
• Press the RUN button to resume testing.
Diluent cartridge must be loaded to
performed requested tests. Tests
requiring the diluent cartridge will be
incomplete.
• Load a DIL1 Cartridge. Refer to Load/Unload
Cartridge Chemistries (CC).
CC Sample Level Sense CAU: CC Sample Level Sense
Error
Error
This error occurs under following
conditions:
Sample ID: sample id
Message ID: 0x02680001
Rack ID: rack id
Subsystem: ccScheduler
Rack Position: rack
position
Sample ID: sample id
• The bottom of the container is
reached before sample is detected
(e.g., empty cup or tube).
• Insufficient sample volume in
container.
• Level sense is triggered sooner than
expected for the given container
type.
• Check sample for adequate volume
• Check proper rack assignment for type of
container used (reserved vs. non-reserved).
Refer to Assigning or Reassigning Reserved
Racks.
• Check for fluid in collar wash – fluid in collar
wash can trigger false level sense.
• Check alignment of sample probe in collar wash.
CAU: CC Sample Probe
Disabled due to Excess
Pressure Errors
Message ID: 0x02620040
Subsystem: ccScheduler
0x0262004B
4
CC Sample Side
Pausing Due to Sample
Rack Subsystem
Stopped
CAU: CC Sample Side Pausing
due to Sample Rack
Subsystem Stopped
Message ID: 0x0262004B
Subsystem: ccSched
0x02660001
4
No Diluent Cartridge
CAU: No Diluent Cartridge
Message ID: 0x02660001
Subsystem: RASched
Chem Name: chem id
0x02680001
4
Rack ID: rack id
Position: rack position
12-17
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
Description
Too many tubes not
venting correctly,
sampling for the CC
probe will be stopped
Event Log
12
ID
Class #
0x02680002
4
Pop-up
Event Log
CC Sample Obstruction
Error
CAU: CC Sample Obstruction
Sample ID:
Subsystem: RASched
Rack ID:
Sample ID:
Rack Position:
Rack ID:
Message ID: 0x02680002
Description
Corrective Action
This error occurs when an obstruction is
detected on a second aspirate attempt
of the same sample.
• Check specified sample for clots. Remove clots
and rerun.
• Check sample volume.
• If Nesting cup used, make sure rack is reserved.
Refer to Assigning or Reassigning Reserved
Racks.
• If multiple obstruction errors occur, flush probe.
Refer to Flush the Sample and Reagent Probe.
• Check tubing from top of probe to ODC sensor
for crimps. If crimped, tubing will need to be
replaced.
Probe detected excessive vacuum in
thick stopper closed tube on second
attempt. Sample is aborted.
• Uncap tube and rerun.
• If occurs consistently for many samples, check
cap piercer for broken blade. Refer to Replace
CTS Blade/Wick (1-Blade Thick CTS Option) or
Replace CTS Blade (1-Blade Narrow CTS Option)
to inspect the blade.
• Perform CC ODC Alignment.
Probe detected excessive pressure in
thick stopper closed tube on second
attempt. Sample is aborted.
• Uncap tube and rerun.
• If occurs consistently for many samples, check
cap piercer for broken blade. Refer to Replace
CTS Blade/Wick (1-Blade Thick CTS Option) or
Replace CTS Blade (1-Blade Narrow CTS Option)
to inspect the blade.
• Perform CC ODC Alignment.
Position:
0x02680003
4
0x02680004
4
Sample tube did not
vent correctly. Remove
cap and reload tube.
CAU: CC Sample Tube Excess
Vacuum Error
Sample ID: sample id
Subsystem: RASched
Rack: rack id
Sample ID: sample id
Position: rack position
CC Sample Probe
Rack ID: rack id
Sample tube did not
vent correctly. Remove
cap and reload tube.
CAU: CC Sample Tube Excess
Pressure Error
Sample ID: sample id
Subsystem: RASched
Rack: rack id
Sample ID: sample id
Position: rack position
CC Sample Probe
Rack ID: rack id
Message ID: 0x02680003
Rack Position: rack position
Message ID: 0x02680004
Rack Position: rack position
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-18
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x02BC1300
4
Pop-up
Photometer Error (error
message), Command:
0xcommand, Error
Number: 0xerror
number
Event Log
CAU: Photometer Error
Message ID: 0x02BC1300
Error Msg: error message
Description
Corrective Action
This error occurs when the photometer
fails to successfully read/analyze a
cuvette. There are several types of
Photometer Smart Module (PSM) errors.
• Press the STOP button and Home the system.
• Check Event Log for specific PSM subsystem
errors. Refer to Event Log.
• Contact Beckman Coulter Support Center for
additional information.
Command: 0xcommand
If for any reason the instrument "Stops"
Error number: 0xerror number while the photometer is trying to read a
cuvette, the photometer will flag an
error. Check the Event Log for any
messages that might indicate a problem
around the same time stamp as the PSM
Error.
Check the Cuvette Center Alignment for
any cuvettes that exceed a 0±6 value.
This will flag a PSM Error.
Failed to Initialize
Photometer
CAU: Failed to Initialize PSM
0x032B0005
2
CC Obstruction
Detection Transducer
Failure
CAU: CC Obstruction Detection This error usually occurs whenever the
Transducer Failure
obstruction transducer does not see fluid
during runtime. Often this comes from a
Message ID: 0x032B0005
clogged degasser or lack of Degassed
Subsystem: rasdSmc
water to the system. The obstruction
detection transducer is looking for a
certain range of pressure during its
primes before sample aspiration. If it
does not see the correct differential, it
will flag a transducer error.
Message ID: 0x02BC2107
The Photometer Smart Module (PSM)
failed to initialize during startup or
homing, the CC side is stopped.
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
12-19
• Check Obstruction Detection Transducer for
obvious leaks or dripping from connections or
the device itself and CC Sample Probe.
• Check for pinch in Water line (from syringe to to
top of probe).
• Make sure the CC sample Syringe is properly
seated.
• Make sure CC Sample Probe tubing is properly
connected at top of Probe. Refer to Step 3-4 of
the procedure.
• Contact Beckman Coulter Support Center for
additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x02BC2107
4
12
ID
Class #
0x03350010
2
Pop-up
MC Obstruction
Detection Transducer
Failure
Event Log
Description
CAU: MC Obstruction Detection MC Obstruction detection hardware
Transducer Failure
failure.
Message ID: 0x03350010
Subsystem: ppsdSmc
0x03880006
3
CC Reaction Carousel
Temperature Out of
Range
CAU: cc rwHtr reaction wheel
temp out of range
This error occurs under the following
conditions:
Message ID: 0x03880006
• When the reaction wheel monitor
sensor readings fall outside of the
+37°C ± 1.0°C specification.
• When the reaction wheel control
sensor readings fall outside of the
+37°C ± 0.1°C specification.
Subsystem: cc rwHtr
0x03EA0009
4
Instrument Detected
Power Loss
CAU: Instrument Detected
Power Loss
Message ID: 0x03EA0009
The instrument detected an interruption
in or loss of the AC input voltage
Corrective Action
• Consistent failures may indicate issues with the
MC Obstruction Detection Transducer.
• Contact Beckman Coulter Support Center for
additional information.
• Check System Status for Reaction Carousel
Temperature. Refer to Temperatures.
• Check Cuvette Status for a cuvette flagged in
red. This may indicate broken or cracked
cuvette. Refer to Cuvette Water Blank Status.
• If a cuvette appears to be damaged, replace it
(extra cuvettes available in Spares kit and may
be ordered).
• Press the STOP button and Home the system.
• If prompted, select Shutdown.
• When the console indicates the shutdown is
complete, turn off the main power switch on the
instrument and the computer.
• Verify the instrument power connections.
• Restart the computer and turn the instrument
back on.
• If the instrument fails to power on or the
problem continues after the instrument has
been rebooted, contact Beckman Coulter
Support Center for additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-20
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
Description
MC Sample Level Sense CAU: Sample Level Sense Error This error occurs under following
Error
conditions:
Message ID: 0x04B2001C
Sample ID: sample id
• The bottom of the container is
Sample ID: sample id
reached before sample is detected
Rack: rack id
Rack: rack id
(e.g., empty cup or tube).
Position: rack position
• Insufficient sample volume in
container.
• Level sense is triggered sooner than
expected for the given container
type.
0x04B2001E
4
MC Sample Probe
Obstruction
CAU: MC Sample Probe
Obstruction
Sample ID: sample id
Message ID: 0x04B2001E
Rack ID: rack
Sample ID: sample id
Position: position
Rack: rack
This occurs on first
attempt
Position: position
Unrecovered MC
Sample Probe
Obstruction
CAU: Unrecovered MC Sample
Probe Obstruction
0x04B2001F
4
Message ID: 0x04B2001F
• Check sample for adequate volume.
• Check proper rack assignment for type of
container used (reserved vs. non-reserved).
Refer to Assigning or Reassigning Reserved
Racks.
• Check for fluid in collar wash – fluid in collar
wash can trigger false level sense.
• Check alignment of sample probe in collar wash.
This error occurs when the MC sample
probe ODC (Obstruction Detection &
Correction) sensor indicates that the
probe is obstructed during sample
aspiration.
• No operator action is necessary.
• The system will attempt a second aspiration
from this sample.
This error occurs when there was an
Obstruction present at the MC sample
probe. The probe tried to clear the
obstruction by flushing, but the
obstruction could not be removed. The
MC side of the system goes to a Stopped
state.
• Flush the MC Sample probe as per the "As
Needed" Flush the Sample and Reagent Probe
procedure.
• If flushing probe is not successful, replace MC
Sample probe. Refer to Replace the Sample and
Reagent Probe.
• If probe is clear and error continues, check for
pinched Sample line tubing.
• If the error continues contact Beckman
Customer Support.
12-21
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x04B2001C
4
Corrective Action
12
ID
Class #
0x04B20026
4
0x04B20027
4
0x04B3000F
4
Pop-up
Event Log
Sample tube did not
vent correctly. Remove
cap and reload tube.
CAU: MC Sample Tube Excess
Vacuum
Sample ID: sample id
Sample ID: sample id
Rack: sample rack id
Rack ID: sample rack id
Position: sample
position, MC Sample
Probe
Pos: sample position
Sample tube did not
vent correctly. Remove
cap and reload tube.
CAU: MC Sample Tube Excess
Pressure
Sample ID: sample id
Sample ID: sample id
Rack: sample rack id
Rack ID: sample rack id
Position: sample
position, MC Sample
Probe
Pos: position
ISE DAC Setting Failed
CAU: ISE DAC Setting Failed
Chem Name: chem id
Message ID: 0x04B3000F
Message ID: 0x04B20026
Message ID: 0x04B20027
Description
Probe detected excessive vacuum in
thick stopper closed tube on second
attempt. Sample is aborted.
• Uncap tube and rerun.
• If occurs consistently for many samples, check
cap piercer for broken blade. Refer to Replace
CTS Blade/Wick (1-Blade Thick CTS Option) or
Replace CTS Blade (1-Blade Narrow CTS Option)
to inspect the blade.
• Perform MC ODC Alignment.
Probe detected excessive pressure in
thick stopper closed tube on second
attempt. Sample is aborted.
• Uncap tube and rerun.
• If occurs consistently for many samples, check
cap piercer for broken blade. Refer to Replace
CTS Blade/Wick (1-Blade Thick CTS Option) or
Replace CTS Blade (1-Blade Narrow CTS Option)
to inspect the blade.
• Perform MC ODC Alignment.
ISE DAC Setting Failed for the specified
chemistry.
• Make sure the ISE module is in the down
position, the cover is in place, the reagent door
is closed.
• Check for reagent volume in bottles or flow cell
leaks.
• Check electrode connections.
MC sample probe detected reagent in
the cup module above the expected
level.
• Prime cup with reagent and make sure it drains.
Refer to Priming MC Subsystems.
• Failure to drain is either caused by low vacuum
or a valve failure.
• Contact Beckman Coulter Support Center for
additional information.
Chem Name: chem id
0x04B30010
4
MC Reagent Level High
in Reaction Cup
CAU: Reagent too full
Chem Name: chem id
Cup: chem id
Message ID: 0x04B30010
Corrective Action
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-22
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x04B30011
4
Pop-up
MC Reagent Level Low
Event Log
Chem Name:
CAU: Reagent too low
Message ID: 0x04B30011
Corrective Action
This error occurs when the MC sample
probe does not sense reagent at the
proper level or at all during the sample
dispense into the cup module.
• Check Reagent bottle volume.
• Check Reagent tubing to straw connection is
tight.
• Make sure the straw is properly seated in the
cap and reaches to the bottom of the reagent
bottle.
• Enable module and perform reagent/water
primes to make sure the cup is filling and
draining properly. Refer to Enable Modules.
• Remove cover and check for leaks or presence
of fluid at the base of the cup assembly and/or
at the electrode/detector port.
• Contact Beckman Coulter Support Center for
additional information.
More than 3 samples in a row had
obstruction errors (clots), MC side
Stopped.
• Prime MC internal probe wash to make sure it is
not obstructed. Refer to Priming MC Subsystems
(select Sample Delivery Subsystem.)
• Probe may need to be replaced. Refer to
Replace the Sample and Reagent Probe.
• If error continues, perform MC ODC Calibration
(Alignment).
No Foam has 0% left.
The system continues to process all samples onboard the sample carousel, then goes to Stopped
state.
Subsystem:
Chem Name:
0x04B30013
4
MC Sample Probe
disabled due to
obstruction errors
CAU: MC Sample Probe
disabled due to obstruction
errors
Message ID: 0x04B30013
0x05780015
4
No Foam Is Empty
CAU: No Foam is Empty
Message ID: 0x05780015
Subsystem: SRMGR
• Make sure the system is in Stopped state.
• Home the system.
• Load No Foam Reagent. Refer to Load/Unload
Reagent.
• If there are sample racks on the DxC sample
wheel, request the system to unload racks.
Refer to Unload All Racks.
12-23
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
Description
12
ID
Class #
0x057A0008
4
Pop-up
Rack Out of Range
Event Log
CAU: Invalid Rack ID
Message ID: 0x057A0008
Subsystem: SRShttl
Description
Corrective Action
The bar code reader was unable to
identify the rack within a specified range
(1-999) during a load or unload of the
rack.
• If this occurs on a rack load:
— Check that the bar code label is on the rack
and facing to the right.
— Check the condition of the bar code label on
the rack.
• If this occurs on a rack unload, perform Unload
All. Refer to Unload All Racks.
• If the error continues, compare the racks shown
on the Main screen with the racks present on the
Sample Carousel to make sure the rack is
physically present.
— If on Main screen, but the rack is not
physically present, reboot system. Refer to
Shutdown.
— If on Main screen, and the rack is physically
present, shuttle latch may not have hooked
the rack properly. Contact Beckman Coulter
Support Center for additional information.
• If this error occurred during a rack unload, check
the results for the samples in the misread rack.
0x057A0009
4
Duplicate Rack ID rack
#
CAU: Duplicate Rack ID
Message ID: 0x057A0009
Subsystem: SRShttl
Rack ID: rack #
This error occurs during a load when a
rack ID is read by the bar code reader
and an identical rack ID is already
present on the system. The system
cannot use duplicate ID racks
simultaneously.
A13914AF
• Compare the number of the rack that was
rejected with the racks currently on the analyzer
by looking at the Main Screen.
• Check the actual bar code that is on the rack
correlates with the number that the system is
rejecting.
• Switch samples to a rack with a different ID or
wait until the samples in the previous rack has
completed testing and has been offloaded.
• If the Main screen shows the Rack, but it is
physically not on the instrument, use the Unload
All feature to clear the sample wheel. Refer to
Unload All Racks.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-24
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
0x057A000A
4
Tube Too Tall for Cap
CAU: Incompatible Tube Type
Piercing Sample Wheel. Message ID: 0x057A000A
Rack; Cup:
Subsystem: SRShuttle
0x057A000E
4
Rack Height Not
Defined
CAU: Rack Height Not Defined
Message ID: 0x057A000E
Corrective Action
This error will only occur when the CTS
thinks it has sensed a tube too soon. In
reality, it is impossible to put too tall of a
tube in because of the Gate Top and the
CTS cover. They sit too low to allow any
marginal tube height.
• Make sure tubes are approved for use and in
appropriate rack for tube size. Refer to Sample
Tubes Validated for CTS.
• Make sure rack is designated properly as a 100
or 75 mm rack in the Reserved Rack screen.
Refer to Assigning or Reassigning Reserved
Racks.
• Make sure the tubes are seated properly in the
appropriate rack.
• If tubes have been re-capped, make sure caps
are fully seated in the tube.
• If error continues perform cap piercer tube
height alignment.
• Contact Beckman Coulter Support Center for
additional information.
CTS is installed and the sample rack
does not have a height defined.
• Make sure the rack height is defined. Refer to
Figure 2.2, Reserved Racks/Obstruction
Detection Setup Dialog Box.
This error will occur when the offload
trays sensor has been triggered. This
error is working as designed in most
cases.
• Unload Racks from the Offload Tray.
• If track is not full, make sure the switch at the far
right end of the track is not pressed in.
• If the error continues, contact Beckman Coulter
Support Center.
Likely cause is a resource issue between
the Instrument computer processes.
There may be a mix-up during file
transfer or a file may be missing.
• At the Red Message screen, select Shutdown.
• If the problem continues after the instrument
has been shutdown, contact Beckman Coulter
Support Center for additional information.
Subsystem: SRShttl
0x057B0008
4
Offload Track Is Full
CAU: Offload Track Is Full
Message ID: 0x057B0008
Subsystem: SRLdr
0x05DC0070
4
Instrument Computer
Interprocess Error
CAU: Boot Task - Message
Receive Error
Message ID: 0x05DC0070
Subsystem: boot
Err no: errno
12-25
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
Description
12
ID
Class #
0x05DC0096
4
Pop-up
Event Log
Smart Module
CAU: Boot Task - SM Download
Download Failed. Smart Failed
Module ID: sm id
Message ID: 0x05DC0096
Description
Smart module communication error
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• If the error continues after homing, Shutdown
the instrument and reboot.
• If the problem continues after the instrument
has been shutdown, contact Beckman Coulter
Support Center for additional information.
This error occurs when there is a motion
error with the Reagent Mixer, either
Rotary or Vertical. The parameter in the
event log entry will show one of the
following:
• Raise canopy and check for obvious obstruction
of the CC reagent mixer.
• Press the STOP button and Home the system.
While system is homing, observe motion of the
CC reagent mixer. The mixer should complete
its operations in a smooth manner.
• If the error continues, check the event log to
determine the specific subsystem error.
• Perform the appropriate vertical or horizontal
CC reagent mixer alignment.
• Contact Beckman Coulter Support Center for
additional information.
Subsystem: boot
SM ID: sm id
0x05DC01F8
4
CC Reagent Mixer
Motion Error
CAU: Homing Error for CC
Reagent Mixer
Message ID: 0x05DC01F8
Subsystem: boot, homing
command
Corrective Action
A13914AF
• "AttachRgtMixer" – error occurred
attaching to smart module 0xC1.
• "RecoverRgtMixer",
"EnergizeRgtMixerVer",
"RaiseRgtMixer" – error occurred
during a vertical movement toward
the home sensor flag.
• "HomeRgtMixerVer" – error occurred
during a vertical movement away
from the home sensor flag.
• "EnergizeRgtMixerCrn",
"MoveRgtMixerToSensor" – error
occurred during a horizontal
movement toward the hardware
sensor.
• "HomeRgtMixerCrane" – error
occurred during a horizontal
movement.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-26
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x05DC01FB
4
Pop-up
CC Reagent Carousel
Motion Error
Event Log
CAU: Homing Error for CC
Reagent Carousel
Message ID: 0x05DC01FB
CC Sample Mixer Error
0x05DC01FF
4
Sample Autoloader
Error
Corrective Action
This error occurs when there is any
homing issue with the Reagent Carousel
Subsystem. This includes the following:
• If reagent cartridges have been loaded recently,
make sure cartridges are fully seated and
refrigerator door is latched.
• Press the STOP button and Home the system.
• Check Event Log for specific RGTWHL
subsystem errors.
• Contact Beckman Coulter Support Center for
additional information.
Subsystem: boot, homing
command
• Upper/Lower reagent decks/motors.
• Both decks flag sensors.
• The magnetic door sensor.
CAU: Homing Error: $s
This motion error is contained within the
Sample Mixer Crane and will only occur
during a home. This can be either a
vertical or rotational error.
• Make sure mixer has the necessary room to
move.
• Make sure the wiring and cabling are secured
properly.
• Make sure mixer paddle is seated firmly in its
housing.
• If mixer appears out of position, perform rotary
or vertical alignment.
• Home and restart the system.
• If motion error continues, contact Beckman
Coulter Support Center for additional
information.
This error encompasses all homing
motions in the Sample Rack Handling
System (SRHS) and occurs whenever
there is a homing issue during an initial
boot. This includes the On Load
Assembly, Shuttle, Sample Wheel, and
the Lifter. If the devices do not find their
home position in time or they jam, the
error will be flagged.
• Check for any racks that may have jammed in
the Sample Rack Handling System or if any of
the devices have jammed together.
• Check for other obstructions if no rack problem
(covers, stoppers, etc.)
• Press the STOP button and Home the system.
• If error continues after Home, print screen and
check event log for specific sub-system homing
error. Contact Beckman Coulter Support Center
for additional information.
Message ID: 0x05DC01FD
CAU: Homing Error: $s
Message ID: 0x05DC01FF
12-27
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x05DC01FD
2
Description
12
ID
Class #
0x05DC0200
4
Pop-up
CC Subsystem Error
Event Log
CAU: Homing Error for CC
Subsystem
Message ID: 0x05DC0200
Subsystem: boot, homing
command
0x05DC0201
4
CC Reaction Carousel
Subsystem Error
CAU: Homing Error for CC
Reaction Carousel Subsystem
Message ID: 0x05DC0201
Subsystem: boot, homing
command
Description
Corrective Action
This is a generic homing error that
occurs whenever there is an issue with
the CC Subsystem. This will normally be
the second error or will be preceded by a
more definite error.
• Press the STOP button and Home the system.
• If the error continues, check Event Log for
specific subsystem errors.
• Contact Beckman Coulter Support Center for
additional information.
The parameter for the event log entry
will either show "InitPhotometer" if the
error occurred during an RA Results
subsystem SpinReactionWheel
command or will show "HomeRA" if this
error occurred while the RA Subsystem
was performing a startup home and
Prime.
An error occurred while homing the
cuvette wash station or reaction
carousel. Check the Event Log (classes 2
and 4) for specific reaction carousel or
cuvette wash station related errors.
• Make sure the cuvette wash head is installed
properly. Refer to Replace Cuvette Wiper to view
wash head.
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• If the error continues after homing, contact
Beckman Coulter Support Center for additional
information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-28
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x05DC0202
2
Pop-up
MC Cups/ISE
Subsystem Error
Event Log
CAU: Homing Error: $s
Message ID: 0x05DC0202
Description
Corrective Action
This generic homing error covers all
aspects of the MC side in the homing
routine. This error has several different
triggers ranging from motion issues to
"Attach" and download failures.
• Press the STOP button and Home the system.
• Reboot system. Refer to Shutdown.
• Contact Beckman Coulter Support Center for
additional information.
• If the event log parameter is
AttachPhos, AttachAlb, AttachTP,
AttachCrea, AttachBun, AttachGlu
or AttachIse then the error occurred
attaching to one of the MC modules.
• If the parameter is InitCupsIse or
PrimeCupsIse, the error occurred
during a cup or ISE initialize or prime
for a stop or cold home.
• If the parameter is
WHomeMCIsePpsd or
WHomeMCCups then the error
occurred during a warm home of the
ISE, MC Sample Delivery subsystem
or MC cups.
12-29
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
System Stopped. Generic homing error
message. Check Event Log for specific
subsystem errors.
12
ID
Class #
0x05DC0204
4
Pop-up
MC Probe/Syringe Error
Event Log
Description
Corrective Action
An error occurred while homing the MC
Probe or MC Sample Syringe drive.
Check the Event Log (classes 2 and 4) for
specific MC probe or syringe related
errors.
• When the instrument goes to Stopped state,
check for possible interference with the motion
of the MC probe or MC sample syringe drive.
• Make sure the ISE, MC cup and sample carousel
evaporation covers are installed properly.
• Press the DxC STOP button. Wait for the motors
to release power (about 30 seconds, listen for
the sound of the Smart Modules resetting) then
Home the system.
• While the system Homes, check for possible
interference issues. If the error continues after
homing, Shutdown the instrument.
• If the problem continues after the instrument
has been shutdown and rebooted, contact
Beckman Coulter Support Center for additional
information.
CAU: Homing Timeout for
Hydro Subsystem
This error occurs when the hydro fails to
respond to commands or fails to attach.
Message ID: 0x05DC0227
This event can be generated by any
Hydro command sent by start.dat
including "AttachHydro",
"StartAutomonitor", "HydroInitStatus",
or "HydroWatchdogOn".
•
•
•
•
CAU: Homing Error for MC
Probe/Syringe
Message ID: 0x05DC0204
Subsystem: boot, homing
command
0x05DC0227
4
No Response From
Hydro Subsystem
Subsystem: boot, homing
command
0x1391000E
Instrument stopped
communicating with
console
ROUTER: Cable down
detected. (/mpcvan/src/
cauman/cau_router.c:1675)
Message ID: 0x1391000E
This Fatal Error will occur when a
network connection has been lost and
the computer console cannot
communicate with the instrument.
Check Event Log for specific subsystem errors.
Press the STOP button and Home the system.
Reboot. Refer to Shutdown.
If the error continues, contact Beckman Coulter
Support Center for additional information.
• Make sure Instrument is on. Refer to ON/OFF
Switch.
• Check Ethernet cable connection at console,
microhub and instrument.
• Reboot system. Refer to Shutdown.
• Contact Beckman Coulter Support Center for
additional information.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-30
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x13940013
7
Pop-up
Event Log
PVT:
PVT:
ERROR: Insufficient
reagent
ERROR: Insufficient reagent
Description
Corrective Action
Cannot perform the test because there is
not enough reagent.
• Load a new PVT reagent cartridge. Refer to
Load/Unload Cartridge Chemistries (CC).
Sample Level Sense error while running
PVT.
• Pour a fresh PVT sample and restart the test.
A motion error occurred while running a
PVT. The test is aborted and no result will
be shown.
• Home and restart the test.
Unable to transition to Maintenance. The
system may still be in a Running state.
• Allow samples to complete before requesting
maintenance.
File: filename
Line: lineno
0x13940014
7
PVT:
PVT:
ERROR: Insufficient
sample
ERROR: Insufficient sample
File: filename
Line: lineno
0x13940015
7
PVT:
PVT:
ERROR: Motion
ERROR: Motion
File: filename
Line: lineno
0x1394001B
7
MAINT: Cannot block
the run button
PVT: cannot block the run
button
File: filename
Line: lineno
Printing for the system
is down. Please reboot
the system at your
earliest convenience.
All requested print jobs
will need to be
requested again after
you have rebooted.
PRTMGR: Task: task - error.
(filename, linenumber)
Logs that the printing is down in the
event log and displays the note to inform
the user.
• Reboot the DxC system. Refer to Shutdown.
• Review and reprint the missing reports.
0x1399002E
7
The printer needs
attention. Please check
the printer and correct
any issues.
PRTMGR: The printer needs
attention. Please check the
printer and correct any issues.
The printer has reported a bad status to
the system and needs attention. After
the printer error has been corrected, the
reports will resume printing.
• Check the printer and correct any issues. If
needed, consult the printer manual to
determine the corrective action for the specific
printer.
12-31
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x1399002D
7
12
ID
Class #
Pop-up
Event Log
There was a problem initializing the
keyboard navigation.
Corrective Action
• Contact Beckman Coulter Support Center for
additional information.
0x139C000C
7
Unable to initialize
keyboard navigation.
0x139D0044
7
Data May Be Out Of
SS: date/time was set
Information to user that changing
Order Due to Date/Time backwards from previous value system date or time (specifically
Change
to new value
backwards) will cause certain data to be
out of order.
• No operator action is necessary. Be aware
events will be out of order.
0x139F0036
9
One or more
STM: One or more chemistries
chemistries will timeout will timeout soon
soon
At least one chemistry will require
recalibration within 1 hour.
• Check Reagent Load/Calibration screen for
calibration information. Refer to Rgts/Cal Screen
Overview.
• Begin to prepare to calibrate required
chemistries. Refer to Request a Calibration.
0x139F0037
9
Within Lot Cal Factor
Timeout in hours
STM: Within Lot Cal Factor
Timeout in hours
The within lot calibration factor for the
specified chemistry will timeout soon.
Hours:
Hours:
• No operator action is necessary. The next time a
fresh cartridge of the specified chemistry is
loaded, it will require calibration.
Chemistry: chem
(Chemistry: chem
Lot No: lot no
Lot No: lot no
Serial No: serial no
Serial No: serial no
Pos: position
Pos: position)
Within Lot Cal Factor
Timeout in hours
STM: Within Lot Cal Factor
Timeout in hours
The within lot calibration factor for the
specified chemistry will timeout soon.
Hours:
Hours:
• No operator action is necessary. The next time a
fresh cartridge of the specified chemistry is
loaded, it will require calibration.
Chemistry: chem
(Chemistry: chem
Lot No: lot no
Lot No: lot no
Serial No: serial no
Serial No: serial no)
0x139F0038
9
Unable to initialize keyboard
navigation for <Subsystem>.
Description
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-32
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x139F0039
9
0x139F003A
9
0x139F0068
7
Pop-up
Event Log
Reagent Cartridge has
less than 5 tests left:
STM: Reagent container has
less than 5 tests left:
Reagent: reagent
Reag: chem
Position: position
Lot No: lot no
Lot #: lot num
Serial No: serial no
Serial #: serial num
Pos: position
MC Reagent container
has low volume:
STM: Reagent container has
low volume remaining:
Reag: chem
(Reag: chem
Volume: volume
Volume: volume
Lot no: lot no
Lot no: lot no
Serial No: serial no
Serial No: serial no)
Corrective Action
Specified reagent cartridge has less than
5 tests remaining.
• Prepare to load another cartridge if another is
not already on-board. Refer to Load/Unload
Cartridge Chemistries (CC).
MC reagent container is getting low.
• Begin preparations to load another container.
Refer to Load/Unload Modular Chemistries (MC).
This error will occur whenever 1 or more
instruments is no longer communicating
Cut Tube Tracking information with the
other networked instruments for any
reason.
• If a networked system has been shutdown and
rebooted, ignore this message. If not, check
power to all Microhubs and network cable
connections.
• Select Status, then the CTS tab to determine
which instrument is no longer connected. Refer
to Show the CTS Tracking Status.
IMPORTANT TS-CTS stands for ThickStopper, Closed Tube Sampling.
CAUTION
To make sure a pre-cut tube is not cut a second
time, any pre-cut tube moved to the
disconnected system should have its cap
removed prior to loading.
12-33
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
STM: TS-CTS Tracking System
CTS Tracking
Information can NOT be disconnect detected
shared between all
Message ID: 0x139F0068
instruments. When you
move a tube to a
different instrument,
remove its cap. You will
be notified when full
CTS tracking is
restored.
Description
12
ID
Class #
0x139F0069
9
Pop-up
Event Log
Description
Corrective Action
All of the systems that we expect to be
networked together are connected (it
has recovered from a disconnect state).
• No operator action is necessary. Databases
automatically synchronize and caps can be left
in place.
WLM: Rack rack ID cannot be
loaded
(FileName:LineNumber)
The sample rack subsystem was unable
to load a rack, usually due to a motion
error. The rack will be removed and
processing will continue.
• Correct the accompanying motion error and
reload the rack.
WLM: Unprogrammed samps,
Rack has been loaded with a sample
which has not been programmed.
• Make sure the complete sample bar code is
readable through the window in the rack.
• Check communication with LIS.
• Manually program if necessary.
Full CTS Tracking is now STM: TS-CTS Tracking System
reconnect detected
available.
When you move a tube
to a different
instrument, it is not
necessary to remove its
cap.
0x13A00004
10
Requested Rack Not
Loaded
Rack: rack ID
0x13A0001C
10
Non-programmed
samples on rack.
Rack: rack ID
[p:PositionSample ID]
[p:PositionSample ID]
[p:PositionSample ID]
[p:PositionSample ID]
WLM: QC DB is xx% percent
full
0x13A00022
10
The QC Database is
xx% full. Archiving is
suggested.
0x13A00023
10
QC Database is full. The WLM: QC DB is full. The oldest
oldest result has been result for
overwritten.
control: control name /
Chem: chem name has been
overwritten.
Refer to Processing Samples Manually.
QC data base is becoming full. When the
database becomes full, the oldest
results will be overwritten. To avoid this,
archive your QC data.
• Archive QC data so it will not be overwritten.
QC database is full. The oldest result for
specified control and chemistry has
been overwritten. Archiving is
suggested.
• Archive QC so that additional data will not be
overwritten.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-34
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x13A00024
10
Pop-up
Event Log
QC Database is full. This WLM: QC DB is full. The result
result was not saved.
for
control: control name /
Chem: chem name has not
been saved
0x13A0003F
10
0x13A00056
10
WLM: Missing calibrator levels
Rack: rack ID
QC database is full and there is no space
for the result to be saved. Results may
only overwrite data for existing,
previously defined control and chemistry
information.
• Archive QC data.
Not all calibrator levels were loaded or
were loaded out of order.
• Reload calibrator racks.
• Make sure bar codes are readable. Refer to Bar
Code Labeling.
• If there are 4 calibrators or less, they must all be
in the same rack.
• If more than 4 levels are required, levels 1–4
must be in the first rack loaded and the next
rack loaded must contain the remaining levels.
Calibrators: calibrator list (File
Name:Line Number)
No sample
programming or
pending test found for
samples in rack #<rack
ID>. Rack will be
unloaded from <rack
location>
WLM: No sample programming A rack was loaded with nothing to run.
The rack is off-loaded and any previous
or pending tests found for
results are printed.
sample on rack.
Required levels for
calibrator not loaded.
Rack will be unloaded
from the sample
carousel.
WLM: Subsequent calibrator
Not all calibrator levels were loaded or
levels not loaded for multi-rack were loaded out of order.
calibrator on rack rack ID (File
Name:Line Number)
Rack: rack ID
Calibrator: calibrator
name
Corrective Action
Rack ID: <rack ID> (<File
Name>:<Line Number>)
• Check the sample status. It may have been
completed and reloaded. Verify the sample
programming.
• Could indicate a problem receiving sample
programming from the LIS.
• Reload calibrator racks.
• Make sure bar codes are readable. Refer to Bar
Code Labeling.
• If there are 4 calibrators or less, they must all be
in the same rack.
• If more than 4 levels are required, levels 1–4
must be in the first rack loaded and the next
rack loaded must contain the remaining levels.
12-35
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x13A00057
10
Incomplete set of
calibrator levels in rack
rack ID for the following
calibrators: calibrator
name list
Description
12
ID
Class #
0x13A00059
10
Pop-up
Scanned barcodes in
rack #<rack ID>
contain invalid
characters. Rack will be
unloaded from <rack
location>
Event Log
Description
WLM: Barcodes contain invalid Sample bar code contains illegal
chars.
characters.
Rack: <rack ID>
[1:<sample ID>]
Corrective Action
• Check the sample bar code for illegal
characters. Refer to Valid Characters for Entries.
• Make sure the complete bar code is visible and
there are no smudges or wrinkles. Refer to Bar
Code Labeling.
[2:<sample ID>]
[3:<sample ID>]
[4:<sample ID>]
0x13A0007E
10
WLM: Received request to
Module: xxxxxx is
disable module: Module (File
disabled due to a
Name:Line Number)
system error. All
module functioning has
now ceased. When the
problem is fixed, enable
the module through
Instrument Commands.
0x13A00092
10
Sample Programs are
too old on rack: rack
number
Position Sample ID
1 sample ID1
2 sample ID2
3 sample ID3
4 sample ID4
WLM: Sample programs too
old
Rack: rack number
[p: sample ID1]
[p: sample ID2]
[p: sample ID3]
[p: sample ID4]
Specified module has been disabled
automatically. This will normally have
severity of IM.
• Enable the module under Instrument
Commands, Enable/Disable Modules. If the
problem continues, it could be a valve or
vacuum problem.
Sample programming exceeds age
specified in setup. Usually indicates host
has reused sample IDs and the old
information was not cleared from the
instrument.
• Clear the existing sample program and
reprogram or requery host. Refer to Clear
Samples.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-36
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
0x13A000CE
10
0x13A000E4
10
Pop-up
Event Log
Description
Samples in rack #
<rack number> have
barcodes longer than
15 characters. Rack will
be unloaded from
<rack location>
WLM: Rack contains samples One or more samples were loaded with
with barcodes > 15 characters. barcodes longer than 15 characters.
Position
1
2
3
4
[3:<cup3 ID>]
Sample ID
ID too long
ID too long
ID too long
ID too long
Module: <module
name> is disabled due
to a stirrer motor error.
All module functioning
has now ceased. Call
Beckman Coulter
Technical Support.
Rack: <rack #>
[1:<cup1 ID>]
Corrective Action
• Check barcodes on samples in rack.
• Reload rack.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
[2:<cup2 ID>]
[4:<cup4 ID>]
WLM: Stirrer motor error module disabled: <module
name> (<file>:<line>)
If a motor speed error occurs, the
following symptoms are exhibited:
12-37
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
• With Albumin (ALBm), Blood Urea
Nitrogen/Urea (BUNm/UREAm),
Glucose (GLUCm), and Total
Protein (TPm), results are
suppressed with an Initial Rate Low/
High Error Flag. When three
consecutive results are suppressed,
the Cup Module is disabled.
• With Creatinine (CREm),
suppressed results are reported with
a Reaction Noise Error Flag. The
CREm Cup Module is not disabled; it
continues to run and reports
suppressed results with an error flag.
• With Phosphorous (PHOSm), low
results are reported. The PHOSm
Cup Module is not disabled; it
continues to run and reports low
results.
• Contact your local service representative to
schedule an inspection of the stirrer motor. DO
NOT use the cup module until your service
representative has inspected and/or replaced
the stirrer motor.
• Review the results reported just prior to the
occurrence of these symptoms and respond in
accordance with your laboratory policies and
procedures.
• From Instrument Commands, disable the
appropriate cup module.
12
ID
Class #
0x13A10012
7
Pop-up
Event Log
MAINT: All or some of MAINT: All or some of the
the report name did not report name did not print
print.
File: filename
Description
Corrective Action
All or some of the report did not print.
• Reprint the report.
Unable to transition to Maintenance.
Samples may still be running.
• Wait for samples to complete and system to go
to Standby before requesting Maintenance
procedure.
Motion error observed while performing
requested maintenance. Test aborted,
no results are available.
• Home and restart the maintenance.
Maintenance procedure aborted
because the reagent has not been
loaded.
• Load the reagent and retry the request. Refer to
Load/Unload Reagent.
Maintenance procedure aborted
because the requested rack was not
loaded.
• The wrong rack was loaded. Check the rack ID
and retry.
• Make sure the bar code faces to the right when
loading.
A problem sending data out the host port
has been encountered. Generated once
and not again until the condition is
cleared. Will continue to retry.
• Check the LIS for status.
• Check cable connections.
• Make sure the host setup parameters have not
been changed. Refer to Host Communications,
Setup.
Line: lineno
0x13A20008
7
MAINT: Cannot block
the run button.
MAINT: Cannot block the run
button
File: filename
Line: lineno
0x13A20015
7
MAINT:
MAINT:
ERROR: Motion.
ERROR: Motion
File: filename
Line: lineno
0x13A20016
7
MAINT:
MAINT:
ERROR: Reagent has
not been loaded.
ERROR: Reagent has not been
loaded
File: filename
Line: lineno
0x13A20019
7
MAINT:
MAINT:
ERROR: Requested
rack not loaded.
ERROR: Requested rack not
loaded
File: filename
Line: lineno
0x13A50024
6
Host Communication
Error, Check Event Log
HC: Host Port Communication
Error
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-38
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
Description
Corrective Action
0x13A50026
6
Host Communication
Line Down, Check
Event Log
HC: Host line down
A problem sending data out the host port
has been encountered. Generated once
and not again until the condition is
cleared. Will continue to retry.
• Check the LIS for status.
• Check cable connections.
• Check the host setup parameters have not been
changed. Refer to Host Communications, Setup.
0x13A50097
6
Host Communication
Line Down, Check
Event Log. No new
messages will be sent.
Review Host Comm
Setup to re-enable.
HC: Chronic Host Port
Communications Error
Communications between the console
and the host has been disrupted for a
prolonged period of time. Check to see
that the Host is operating and
responding to messages sent by the
console. Check the cable is correctly
attached.
• Check the LIS for status.
• Go to Host Communications, Setup. Exiting
screen will force the system to reestablish
communication.
• Check cable connections.
• Make sure the host setup parameters have not
been changed.Refer to Host Communications,
Setup.
0x13A70004
7
Instrument not in
proper state.
ICMD: System Error. Cannot
HOME
System is not in proper state for Homing
(usually still Stopping). Must be Standby/
Stopped/Disabled/PVT/Diag/Maint or
Align
• Wait for the system to get to Standby/Stopped/
Disabled/PVT/Diag/Maint or Align.
• Reboot if necessary. Refer to Shutdown.
ICMD: Cannot HOME in current The instrument is not in the proper state
for Homing (usually still Stopping). All
state.
sides of the instrument must be in
File: filename
Standby, Stopped, Disabled, PVT, Diag,
Line: line number
Maint or Align.
• Wait for the system to go to a Standby, Stopped,
Disabled, PVT, Diag, Maint or Align state.
• Select Instr Cmd and Home.
• If problem continues, reboot the DxC system.
Refer to Shutdown.
ICMD: Cannot PAUSE in current The instrument is not in the proper state
state
to accept a PAUSE command. Only
select PAUSE when not already in a
File: filename
Pausing state and at least one side of the
Line: line number
instrument is running.
• If Pause was previously selected, the System will
go to Standby automatically.
• Select Pause only when at least one side of the
system is running.
• Reboot if necessary. Refer to Shutdown.
CAU: restart may be required
File: filename
Line: line number
Instrument not in
proper state.
or
Unable to send Home
message.
0x13A70006
7
Instrument not in
proper state.
12-39
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
0x13A70005
7
12
ID
Class #
0x13A70007
7
Pop-up
Instrument not in
proper state.
Event Log
ICMD: Cannot SHUTDOWN in
current instrument state.
File: filename
Line: line number
Description
Corrective Action
System is not in proper state for
Shutdown command. Only select
Shutdown when all sides of the
instrument are in Standby, Stopped,
Disabled. Press the STOP button if
necessary to obtain these states.
• Wait for all sides of the system to go to a
Standby, Stopped, or Disabled state.
• Wait for the DxC system to go to Standby.
• Select Instr Cmd and Home.
• If problem continues, press the DxC STOP
button. Wait for the motors to release power
(about 30 seconds, listen for the sound of the
Smart Modules resetting) then Home the
system.
• To immediately shutdown, press the STOP
button and wait to go to the Stopped state, then
request Shutdown.
0x13AC0008
7
Cannot create socket.
BOOT: Cannot create socket
Unable to create a network socket
(shutdown didn't complete cleanly).
• Reboot. Refer to Shutdown.
0x13AC000B
7
Unable to connect to
instrument
BOOT: Select failed
Unable to boot.
• Make sure the instrument power is on and
reboot. Refer to Shutdown. Continued errors
may indicate an incorrect hardware address.
0x13A70010
7
Instrument not in
proper state.
ICMD: Cannot disable Lower
Reagent Carousel in current
instrument state.
CC was not in Standby/Stopped state
when the Lower Reagent Carousel was
disabled.
• Wait until the instrument goes to a Standby or
Stopped state before attempting to disable the
lower reagent wheel.
File: filename
Line: line number
A13914AF
0x13A70012
7
Unable to send
message to DxC
Instrument.
ICMD: Cannot <Action> Waste Unable to send request to DxC
B operation, possible line down instrument. Check to see if the cable is
sending msg. #916
correctly attached.
• Check the connections between the DxC
Instrument and the Console Computer.
• If the problem continues, reboot the DxC
system. Refer to Shutdown.
0x13A70013
7
Unable to send
message to DxC
Instrument.
ICMD: Cannot Enable/Disable
CAU modules
(<EnDisStatus>), possible line
down sending msg. #932
• Check the connections between the DxC
Instrument and the Console Computer.
• If the problem continues, reboot the DxC
system. Refer to Shutdown.
Unable to send status update to DxC
instrument. Check to see if the cable is
correctly attached.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-40
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Table 12.10 Error Messages and Corrective Actions (Continued)
ID
Class #
Pop-up
Event Log
Description
Corrective Action
0x13AC0016
5
Automatic smart
module download:
smart modules.
BOOT: Automatic smart
module download: smart
modules
After new software is loaded, new
software was downloaded to the
indicated smart module.
• No operator action is necessary.
0x13AC0040
7
STOP button pressed.
Press HOME to home
instrument.
BOOT: STOP button pressed
This popup is expected when the
Operator presses the STOP button.
• Home the system.
0x13AC0051
4
Instrument Computer
Error
Boot: Instrument attempted a Likely cause is an Internal
second ICC (Instrument Control Communication issue. Possible bad
Computer) boot
Ethernet connection causes Instrument
to attempt a second boot.
• At the Red Message screen, select Shutdown.
• If the problem continues after the instrument
has been shutdown, contact Beckman Coulter
Support Center for additional information.
0x13AD000B
7
Database Version
number on disk doesn't
match Database
Version number.
Backup/Restore: Database
The contents of the backup are from a
Version number on disk doesn't different version of the Console Software
match Database Version num and cannot be restored on this version.
• Use a newer disk if available.
Refer to Backup the System.
Message ID: 0x13AC0040
File: file
Line: line
0x13AD0013
7
Error copying to floppy
Backup/Restore: Error
copying to floppy
File: file name
• Make sure the diskette is inserted correctly.
• Try another diskette.
Refer to Backup the System.
Cannot format floppy.
• Make sure the diskette is inserted correctly.
• Try another diskette.
Refer to Backup the System.
System cannot identify inserted disk.
Probably a blank disk or incorrect format.
• Use another disk if available.
Refer to Backup the System.
Line: line num
0x13AD001E
7
Error formatting floppy
Backup/Restore: Error
formatting floppy (fdformat)
File: file name
Line: line num
0x13AD0020
7
No Contents file on
floppy
Backup/Restore: No TOC
floppy file
File: file name
Line: line num
12-41
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
System cannot identify inserted disk.
Backup and Restore procedure will
abort.
12
ID
Class #
0x13AD0029
7
Pop-up
Event Log
Backup Type on disk
doesn't match request
type
Backup/Restore: Backup type
on disk doesn't match request
type
Description
Corrective Action
Incorrect disk format, probably a
different backup.
• Use another disk if available.
Refer to Backup the System.
Trying to restore from a disk for a
different system.
• Use another disk if available.
Refer to Backup the System.
The contents of the backup are from a
different version of the Console Software
and cannot be restored on this version.
• Use another disk if available.
Refer to Backup the System.
File: file name
Line: line num
0x13AD002A
7
Instrument serial
number on disk doesn't
match Instrument serial
number
Backup/Restore: Inst serial
number on disk doesn't match
Inst serial num
File: file name
Line: line num
0x13AD002B
7
S/W Version on disk
Backup/Restore: SW Version
doesn't match MPC S/W on disk doesn't match MPC SW
Version
Version
File: file name
Line: line num
0x13AD0040
7
Bad Floppy, replace
floppy and try Backup
again
Backup/Restore: Bad floppy, Cannot check backup.
cannot read from floppy during
backup
• Repeat Backup with different disk.
Refer to Backup the System.
File: file name
Line: line num
0x13AD0041
7
Chemistry Version
number on disk doesn't
match Chemistry
Version number
Backup/Restore: Chemistry
The contents of the backup are from a
Version number on disk doesn't different version and cannot be restored
match Chemistry Version num on this version.
File: file
Line: line
• Use another disk if available.
Refer to Backup the System.
Troubleshooting Calibration and Result Errors
Common Error Messages and Corrective Actions
12-42
Table 12.10 Error Messages and Corrective Actions (Continued)
A13914AF
Glossary
Absorbance
The difference between the amount of light entering a solution (incident light) and the amount
of light passing through solution (transmittance) without being absorbed, to determine the
concentration of the substance in solution.
Accession Number
A unique ID (between 1 and 65535) assigned by the instrument for each sample, based on the
order in which the sample is scheduled. This is an internal system ID used for scheduling and
is not visible to the user.
ADC
Analog to Digital Conversion.
Alphanumeric Character
Characters taken from one or more of the following: A–Z, a–z, 0–9.
Analyte
The component being measured.
Analytical Range
Analytical ranges are internal system limits used to set the high and low measuring limits of the
system. These are the ranges that Beckman Coulter has verified can be achieved by the system.
The ranges for each analyte can be found in the Synchron Clinical Systems Chemistry
Information Manual and the Synchron Clinical Systems Chemistry Reference Manual. Results
exceeding these limits are flagged OIR HI or OIR LO
(Out of Instrument Range).
Antibody (Ab)
A protein made by the body to defend itself against a foreign substance (antigen). Antibody
molecules bind noncovalently to the antigen that triggers their production.
Antigen (Ag)
A foreign substance that triggers an antibody response from the body's immune system.
Antigen Excess (AGXS) Testing
A test for unbound (excess) antibody remaining in solution after the primary reaction with
antigen. Excess antibody is detected by the further addition of antigen and measurement of
reaction rate.
Aspirated
Indicates whether an initial aspiration of the sample has been accomplished.
Assay
A test. A single concentration determination.
Assigned Mean
The mean value defined for a control.
A13914AF
Glossary-1
Glossary
ASTM Protocol
A standardized computer interface specification following the guidelines from the American
Society for Testing and Materials.
Autoloader/Offload Track
When viewed from the front of the system, the autoloader is on the left and holds up to 25
sample racks in preparation for presentation to the DxC 800 system. The DxC 600 system has
room to load a maximum of 14 racks.
There is also space for 25 sample racks in the offload track as they are removed from the Sample
Carousel upon completion. Combined, these two components allow for over one hour of
uninterrupted sample processing, with no operator intervention involved.
Auto ORDAC
Automatic Overrange Detection and Correction. A system feature that detects a chemistry
result that exceeds the instrument analytical range.
Back-to-Back
A measure of system precision during calibration. The difference in the response from two,
usable calibrator replicates.
Bar Code Reader (Sample)
The Bar Code Reader is a Class II fixed-beam laser scanner. It is used to read the rack bar code,
the sample bar code (if present), and the background bar codes as the rack travels past. The rack
bar code and sample bar code (if present) are used to identify the sample and link it to the
appropriate sample programming.
Batch
A group of samples with identical sample programming information, with the exception of the
Sample ID.
Baud Rate
The serial data transfer speed between two or more communication devices.
Bidirectional Interface
Two-way transmission of information from the host computer to the instrument (usually
sample programming) and from the instrument to the host computer (usually results).
Blanked
A sample or reagent baseline, photometric measurement subtracted from the reaction read
window measurement.
Calculation, Beckman Coulter-Defined
A calculation formula, supplied by Beckman Coulter, which is uneditable and undeletable.
Cartridge Chemistries (CC)
Chemistries whose reagents are packaged in a three-chamber cartridge designed to hold up to
three levels of reagent.
Check Digit
A character used to mathematically check that a bar code is read accurately.
Glossary-2
A13914AF
Glossary
Chemistry List
The comprehensive list of all Beckman Coulter chemistries available to the user.
Chemistry Menu
The collection of chemistries configured by the user from the chemistry list for display/
selection in sample programming and panel configuration.
Chromophore
A colored substance that is measured in spectrophotometry.
Code Length
A parameter defined by the user so that only one bar code length is accepted.
Collar Wash
A component of the sample probe assembly that washes the external and internal surfaces of
the probe.
Configured Chemistry
A chemistry, selected from the chemistry list, programmed to be included as part of the
chemistry menu.
Constituent Code
A quality assurance (QC) program code that can be defined for a control chemistry.
Control ID
The equivalent of a Sample ID for a control. A maximum of eight unique Control IDs can be
defined for each Control Name.
Critical Range
A user-defined range consisting of low and high values that are used to flag patient results as
"critical low" or "critical high".
CTS
Closed Tube Sampling.
CTS Auto-Gloss
A lubricant used with 1-Blade Thick CTS.
Cup Insert (Metal 0.5 mL)
This metal cup insert is placed into a 16 × 100 mm rack. An autoanalyzer cup is then inserted
into the cup insert and run in the "reserved rack" mode.
Cuvette
One of the receptacles on the reaction carousel in which sample and reactants are mixed and in
which the reaction is measured.
Cuvette Pathlength
The distance light travels through fluid in a cuvette. Pathlength is used as a measurement in
absorbance (Abs) calculations.
A13914AF
Glossary-3
Glossary
Data Bits
Low or high voltage signals transmitted through the serial communication data line. Data bits
are transmitted after a Start Bit and before the Parity Bit and Stop Bit. The user can configure
the number of bits to be transmitted between the start bit and stop bit.
Database
A collection of data stored and organized for rapid access and retrieval.
DGKCh
Deutsche Gesellschaft für Klinische Chemie (A German Clinical Chemistry Association).
Dialog Box
A small window that generates from a screen, requiring interaction from a user through the use
of text fields, check boxes, and command buttons. A dialog box, smaller in size than a screen,
does not generally include a row of function buttons.
Diluent
Fluid used to dilute another fluid.
Dilution Factor, Off-Line
A factor defined by the user by which the sample result is multiplied.
Discrete
The state of reactions taking place in their own separate container.
Double Trigger
Two different reagent components, added to the cuvette after sample addition, that initiate the
desired action.
Downgoing
The decrease in absorbance as a reaction progresses.
EIC
Electrolyte Injection Cup.
Electronic Maintenance
Maintenance items are grouped together by frequency of performance. Only the maintenance
items appropriate for the particular system and installed hardware are shown. On the
Scheduled Maintenance Log screen these groups have been placed under separate labeled tabs.
Each of these tabs is accessed by using the touchscreen or by using the mouse. Selecting the
highlighted tabs will reveal the procedures requiring attention highlighted in yellow. Yellow
highlights will also alert the operator when any maintenance item on the respective tabs is due
to be performed.
Endpoint
A reaction that has come to completion before the absorbance measurements are taken. It is
expressed as absorbance (A).
Enzyme Validator
A human serum, albumin-based, value assigned material that can be used as a calibrator to
provide IFCC/DGKCh equivalent answers for selected enzymes.
Glossary-4
A13914AF
Glossary
Enzyme Verification
A means of adjusting enzyme chemistry reporting to IFCC methods or to country specific
correlation methods.
File Number (QC)
A unique number that must be assigned to each chemistry defined for a control.
Flow Cell
The component that houses the Ion Selective Electrodes (ISE).
Help System
A Help System is available online in six supported languages. The Help System can be accessed
by selecting the Help icon
on the right side of the Menu Bar. When selected, the UniCel DxC
Synchron Clinical Systems Instructions For Use manual may be installed.
Host Query
A form of bidirectional interface communication. When the instrument reads a bar coded
Sample ID for which it has no program, the host computer is queried for the program associated
with that sample. The host then sends the queried information to the system.
ICC
Instrument Control Computer. The central, controlling processor of the system that provides
large scale timing and communication with the MSMCs.
Icon
A small pictorial representation of a functional area. The icons are found on the menu bar at
the top of the screen.
IFCC
International Federation of Clinical Chemistry.
IFU
Instructions For Use.
Imprecision
The lack of reproducibility of test results.
Instrument Printable Range
The Instrument Printable Ranges are internal system limits and are found in the Reportable
Range setup screen. These ranges actually exceed the analytical ranges by a factor. This factor
accounts for precision variations and still allows a result to print even though it exceeds the
analytical range slightly. Results outside this range are suppressed.
Intercharacter Gap
The space that separates two characters in a bar code.
ISE
Ion Selective Electrode.
Laboratory Information System (LIS)
A laboratory host computer that can be interfaced to an DxC analyzer.
A13914AF
Glossary-5
Glossary
Lot-Specific Parameter Card
A Beckman Coulter-provided card which is imprinted with bar codes. The card allows for lotspecific calibration information to be loaded into the DxC system.
LPIA
Large Particle Immuno Assay
Microtube
A sample tube, manufactured by Beckman Coulter, intended for low-volume samples and that
can be bar coded.
Modular Chemistries (MC)
The discrete, cup modules located on the left side of the instrument: Glucose, BUN, creatinine,
phosphorous, albumin, Total Protein. The electrolytes, analyzed in the flow cell, are also
located in this area.
MSMC
Multiple Smart Module Controllers. Processors that work in conjunction with the ICC and
communicate with the network of subsystems.
Multipage List
A list that contains more than one screen page of information, requiring use of Page Up/Page
Down to access additional pages.
Multipoint Span
The difference between consecutive calibrator rates or absorbances. The maximum of six
consecutive calibrator rates seen on a standard curve for levels 0-1, 1-2, 2-3, 3-4, 4-5, 5-0. Span
indicates a measure of sensitivity over the entire curve.
No Foam
Reagent additive automatically added to the system waste to prevent excessive foaming that
may occur with certain reagent combinations.
Numeric Character
The counting digits, 0-9.
Offset
A value which is added or subtracted following the application of a slope value to a chemistry
result.
On-Board Reagent
The chemistries, buffers, and diluents that are currently loaded onto the system.
ORDAC
Over Range Detection And Correction. When enabled, this feature causes specific high test
results to be rerun using a sample diluted automatically by the system or using a smaller sample
volume (depending on the test being rerun).
Panel
A group of tests that are ordered together.
Parity
A method of detecting serial data transmission errors.
Glossary-6
A13914AF
Glossary
Patient Demographics
Information that is associated with a patient, such as name, ID, age, or sex.
Pause
An instrument command which allows results to be generated for all samples in progress before
returning the instrument to Standby status.
Peltier
A type of temperature control system that heats or cools depending on the ambient
temperature.
Pop-Up Window
An information box that pops up to provide necessary system information. A pop-up can
appear as the result of an error in instrument or chemistry performance.
Prime
A process that flushes components (such as tubing) and replenishes fluid levels to maintain the
integrity of the system.
Primary Tube
A tube into which the patient sample is collected.
Pull-down Menu
A button on a screen or dialog box that, when selected, presents a list of items options from
which to choose. These buttons, triangular in shape, appear beside a text field.
Range Length, Bar Code
The limits of the code length which may be defined for a symbology.
Rate
The type of reaction in progress while absorbance measurements are taken. The reaction is
expressed as rate of change (Δ A/min).
Reagent Acronym
The two-to five-character abbreviation of the chemistry name.
Reagent Carousel
The Reagent Carousel Compartment provides an on-instrument storage area for the individual
reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time. The
storage compartment is refrigerated and fan-cooled to maintain a temperature of +5°C (±3°C).
Reference Interval (normal range)
A user-defined range consisting of low and high values that are used to flag patient results as
"low" or "high".
Replicates
The number of repetitions performed for a test or sample.
Reportable Range
Reportable Ranges are operator defined in System Setup. They represent the ranges that are
verified at a site. These ranges may or may not be the same as the analytical ranges depending
on the needs of a site. Results exceeding these limits are flagged ORR HI or ORR LO (Out of
Reportable Range).
A13914AF
Glossary-7
Glossary
Reserved Racks
A reserved rack may be used for uncapped, primary or secondary tubes that have a small
volume of sample, for example: nested cups on primary tubes, Microtubes and pediatric
capillary collection tubes.
Screen
A feature of the software interface that presents information in a rectangular window,
including text fields and a row of function buttons at its lower level.
Secondary Tube
A tube, also called a transfer tube, which contains a portion of patient sample, control, or
calibrator from another container.
Slope
A value by which a result is multiplied to make the results comparable to other systems.
Span
The difference between the average ADC value of Calibrator 1 and the average ADC value of
Calibrator 2. Span is used to check for system or reagent sensitivity.
Smart Module
An intelligent, computer-controlled mechanical device designed to perform a specific motion
control or environmental function.
Special Character
Any viewable or printable keyboard character that is not an alphanumeric character, including
the following:
`˜!@#$%^&*()-_=+\|[]{};:'",<>./?
Standby
An instrument mode where all requested activity is complete and motion is stopped.
Start/Stop Bits
Synchronization method that signals the start and end of data transmission in serial
communication. The data bits are proceeded by the Start bit and followed by the Stop bit.
System Exerciser
A set of programs that run a series of tests, designed to test the proper action sequence of each
component of the instrument. An offline diagnostics program used by Beckman Coulter
Service.
Symbology, Bar Code
A set of rules for encoding and decoding information contained in a bar code symbol. Examples
of symbologies are Code 39, Code 128, Codabar, and Interleaved 2 of 5.
Target Value
The known concentration of a calibrator or control.
Trigger
The reaction initiated by a reagent component that is added to the cuvette after sample
addition and primary reagent have pre-incubated.
Glossary-8
A13914AF
Glossary
Unidirectional Interface
One-way communication. Results are communicated from the instrument to the host
computer only.
Unit
An expression of concentration, such as weight/volume (for example, mg/dL), mass/volume
(for example, mol/L), and International Units/volume (for example, IU/mL).
Upgoing Reaction
The increase in absorbance as a reaction progresses.
URDAC
Under Range Detection And Correction. Specific chemistries that are below the normal
analytical range will automatically be rerun with a larger sample volume.
Wash Concentrate
The on-board fluid used to automatically rinse the probes and cuvettes.
A13914AF
Glossary-9
Glossary
Glossary-10
A13914AF
Index
Numerics
B
10% bleach solution, 9-81, 9-84, 9-85, 9-87, 9-113
1-Blade CTS option
See Cap piercer
1-Blade Narrow CTS, 2-5
1-Blade Thick CTS, 2-5
70% isopropyl alcohol, 9-14, 9-27, 9-31, 9-81
Backup, 11-13
Alignment data, 11-13, 11-16
System parameters, 10-2, 11-13
Bar code reader, 1-19
Hand-held (MC), 1-13
Reagent, CC, 1-19
Sample, 1-10
Bar codes, QC, 5-7
Printing, 5-7
Beer's Law, 1-54
Boot
Full boot, 10-14
Buttons, 1-xxxiv
A
Absorbance versus time, 7-8
AccuSense glucose sensor
Connector port, 9-60
Drain reaction cup for sensor, 9-59, 9-60
Gasket, 9-59, 9-62
Prepare prior to replacement, 9-60
Replace, six-month, 9-48, 9-61, 9-63
Stir bar and cup, clean, 9-62
Air filters
Change, 9-41
Clean, 9-41
Alarm/Annunciator
See Status Alarm/Annunciator
Alignment
See UniCel DxC Synchron Clinical Systems
Reference Manual
Alkaline buffer damper assembly
Adjust fluid level, 9-20
Fluid level high, 9-22
Fluid level low, 9-21
Check fluid level, 9-23
Replace alkaline buffer reagent, 9-18
Archive QC Data, 5-23
Auto ORDAC, 3-4
Auto serum index, 3-4
Autoloader, 1-9
C
Calibration
Acceptance limits, 4-27
Bypass, 4-25
Calibrator set point modifications, 4-28
Enzyme validator, 4-23
Error detection, 1-53
Extending calibration time, 4-26
Failure messages, 4-18
Formulas
Endpoint and first-order, 1-44–1-49
Non-linear, 1-50, 1-51
Override, 4-24
Reprint calibration report, 4-31
Request
Canceling a calibration request, 4-18
Slope offset adjustment, 4-29
Status, 4-14
Within-lot calibration, 4-19
Designations, 4-22
Enabling within-lot calibration, 4-19
Index-1
Index
Frequency, 4-19
Limitations, 4-22
Cap piercer
1-Blade CTS option
CTS Auto-Gloss
1-Blade Narrow CTS, 1-11
1-Blade Narrow CTS option, 9-32
1-Blade Thick CTS, 1-11
1-Blade Thick CTS option, 9-32
See CTS
Carousel, 1-6
Cartridge chemistries (CC), 1-43
Calibration theory, 1-43–1-53
Spectrophotometric methods, 1-54
Cartridges, 1-19
Reagent, 1-19
CC — Cartridge chemistry, 9-2
CC reagent mixer, clean, 9-31
CC sample mixer, clean, 9-31
CC sample probe, reagent probes and mixers
Automated cartridge chemistry probe
cleaning
Load CCWA, 9-104
CCWA — Cartridge chemistry wash solution, 9-2
Chemistry parameters, 8-4
Chemistry print name, defining, 3-6
Chemistry, configuring, 3-5
Clearing chemistries, 3-6
Deleting a chemistry, 3-6
Inserting a chemistry, 3-6
Chloride Electrode tip, Replace, 9-65
Closed Tube Sampling
See CTS
CO2 alkaline buffer reagent straw and line,
bleaching
Line #33, 9-87
CO2 measuring electrode membrane, 9-74
Broken, 9-79
ISE service, 9-75
Remove, 9-75
Replace, 9-77
Wrinkled, 9-79
Configuration, system, 3-31
Constituent code, 5-6, 5-11
Control, 5-9–5-14
Bar codes, 5-7
Constituent code, 5-6, 5-11
Definition, 5-4
Deleting, 5-13
Index-2
Editing, 5-9
Fields, 5-6, 5-11
File number, 5-6, 5-11
Printing, 5-13
QC chart, 5-17
QC file list, 5-14
QC summary, 5-15
Reviewing, 5-12
Copy to disk feature, 5-21
Creatinine clearance results
Calculation, 3-23
Critical ranges, 3-19
Critical Result Rerun, 3-15
Critical result rerun, 7-6
CTS — Closed Tube Sampling, 9-2
CTS (Closed Tube Sampling)
1-Blade Narrow CTS option, 1-11
1-Blade Thick CTS option, 1-11, 2-5
Blade count, 10-3
CTS Auto-Gloss, 2-v, 11-2
CTS Count, 10-3
CTS Tracking, 2-x, 10-7
4-Blade Foil CTS option, 2-5
CTS Auto-Gloss, 9-10
CUPs lamp and sensor calibration, 9-29, 9-30
Cuvette reaction system, 1-21
Cuvette washer probe, inspect
Blocked probe, 9-108
Cuvette washing
Wash station, 1-23
Cuvette water blank status, 10-6
Cuvette wiper
Reinstall, 9-12
Replace, 9-10
Cuvettes
Automated wash all cuvettes, 9-110
D
Data storage, 7-1
Results, 7-1
Sample programs, 7-1
Database version, 3-23
Date/time setup, 3-13
Deleted results, 11-7
Deleting, 5-19
Control, 5-12
Critical result rerun, 7-6
QC data point, 5-20
Demographics, 3-14
Index
Dilution factor, 6-10
Drain assembly, 1-26
Drugs of abuse testing (DAT), 1-53
E
Editing
Control, 5-9
EIC, 9-81
EIC — Electrolyte injection cup, 9-2
EIC ports, flushing, 9-81–9-87
ISE service, 9-81
Electrolyte injection cup (EIC), 1-15
Electrostatic Discharge, 9-1
Enable/disable modules, 10-16, 10-17
Enzyme validator, 4-23
Enzyme verification, 1-53
Error detection
See Calibration
Error detection limits, 8-13
Event log, 11-6
Exit check criteria, 8-17, 8-18
Expanded user defined chemistry feature, 8-20
Extinction coefficients, 8-16
F
Failure messages, calibration, 4-18
File number, 5-6, 5-11
Flow cell (ISE), 1-16
Flow cell flush kit, 9-92
Flow cell tubing #23, 9-93
Flow cell tubing #27, 9-93
Flow cell tubing #35, 9-93
Flow cell, flushing
ISE service, 9-92–9-95
H
Hazards, 2-v
Home, 10-8
Host specifications
See Host Interface Specifications Manual (P/
N A16150)
Hydropneumatic system, 1-24
Status, 10-5
I
Icons, 1-xxxiv
ICS/smart module status, 10-5
Immediate reporting, 3-14
Instrument commands, 10-8
Intended use, 1-xxxiii
ISE — Ion selective electrode (flow cell
module), 9-2
ISE drain cleaning, six-month
Drain top, 9-90
Drip screen, 9-90
ISE service, 9-89, 9-92
ISE module, 1-13
ISE reference solution, 9-52
ISE service, 9-54, 9-65
K
Keyboard, 3-29
L
Labels, 2-xv–2-xxiii, ??–2-xxiv
Language/keyboard, selection, 3-29
Levey-Jennings, 5-16
Log fields, 1-40, 1-41
LPIA (large particle immuno assay)
module, 1-21, 1-22, 8-1, 8-6, 10-6
M
Main screen, 1-27–1-42
Post run summary, 1-39, 1-42
Pre run summary, 1-39, 1-42
Results recall, 1-38, 1-39
Sample unload, 1-39
Main screen and program structure, 1-27
Maintenance, 9-1, 11-6
Manual
Conventions, 1-xxxiii
How to use, 1-xxxv
Scope, 1-xxxiii
Manual assignments, 6-7
Math models, 1-50, 1-51, 8-6
MC — Modular chemistry, 9-2
MC components, reassemble, 9-30
Mixer wash cup, 1-20
Reagent, 1-20
Modem, 11-12
Modular chemistries (MC), 1-53
Basic components, 1-17
Modular reagents
Index-3
Index
No Foam, 9-10
Manual assignments, 6-7
ORDAC, 6-10
Rack status, 6-3
Rack/cup position, 6-4
Sample ID, 6-4
Sample status, 6-4
Pushers, 1-10
O
Q
Offload track, 1-9
On/off switch, 10-13
ORDAC, 6-10
Auto ORDAC, 3-4
Manual, 6-10
QAP Disk, 5-21
Quad-ring
BUNm/UREAm electrode, 9-27
CO2 measuring electrode, 9-76
Potassium and calcium electrode, 9-57, 9-67
Quality Assurance Program (QAP)
Copy to disk feature, 5-21
Quality control (QC), 5-1–5-25
Chart, 5-16
Printing QC bar code assignments, 5-7
QC action log, 5-20
QC chart, 5-16
QC file list, 5-14
Displaying, 5-14
QC log, 5-18
Summary, 5-15
Check levels, 9-10
Modules, 1-17
Modules, enable/disable, 10-16
N
P
Panels, 3-15
Patient results
Critical results rerun, 3-14, 3-19, 7-6
Pause, 10-9
PHOSm, cleaning precipitate
Protein precipitate, 9-106
Photometer assembly, 8-6
Post run summary, 1-39, 1-42
Potassium and calcium electrode tips
Replacing, six-month
ISE service, 9-54
Removing/installing, 9-52–9-58
Power Subsystem Status, 10-4
Pre run summary, 1-39, 1-42
Precautions, 2-viii–2-xiv, 5-9
Prime, 11-1
Printers, 3-30
Printing, 5-13, 7-7
Control, 5-13
Data, 1-38
QC chart, 5-17
QC file list, 5-14
Recalled results, 7-7
Priority
Position, 1-9
Priority load, 1-9
Probes, clean, 9-14
Processing parameters, 8-8
Programming samples, 6-1
Batch, 6-11
Dilution factor, 6-10
Manual, 6-10
Index-4
R
Racks, 1-7
Sample, 1-7
Sizes, 1-7
Status, 6-3
Ratio pump, 1-14
Reaction carousel, 1-21
Cuvettes, 1-21
Reaction type, 8-4
Reagent carousel, 1-19
Reagent cartridges, 1-18
Reagent handling system, CC, 1-17
Reagent parameters, 4-10
Loading, 4-11
Reagent status
Sorting reagent status
Days left, 4-3
Tests left, 4-3
Reagent syringe, 9-43
See also Sample and reagent syringes,
replacing three-month
Recalling results
Index
Displaying, 7-5
On-board samples, 1-38
Patient ID, 7-4
Printing, 7-7
Rack and position, 7-3
Run date/time, 7-4
Sample ID, 7-2
Replicates, 3-16
Reportable range, 3-17
Reports, 3-16
Statistical summary, 7-10
Reserved racks, assigning, 2-xiii
Reset, 10-12
Restore, 11-13
Results, 1-39
Results recall, 1-38, 7-1
Main screen, 1-38
Retainer nut, 9-26, 9-57, 9-62, 9-67
Review, 5-24
Review results, 1-41
Reviewing, 5-12
S
Sample
Carousel, 1-12
Gate, 1-10
Handling system, 1-6
ID, 6-5
Log, 1-39–1-41
Programming
See Programming samples
Racks, 1-7, 2-2
Replicates, 3-16
Type
Default, 3-13
Sample and reagent syringes, replacing threemonth
Checking for bubbles, 9-47
Plunger rods, 9-44
Syringe rod replacement, 9-44
Sample syringe, 9-43
CC sample syringe, 9-44
MC sample syringe, 9-44
Serum index
Auto ORDAC, 3-4
Serum Index result, 3-15
Service
Monitor, 3-27
See also Metering Manual (P/N 967259)
Setup, 3-30
Setup
Screens, 3-1
Shutdown, 10-12
Shuttle, 1-10
Silicone compound, 9-28
Smart modules
Status, 10-5
Sodium Azide preservative, 2-vii
Software version, 3-23
Special calculations, 3-20
Specifications, system
Clearances, 1-2
Elevation, 1-3
Operating temperature, 1-3
STAT, 3-14
Statistical summary report, 7-10
Status
Alarm/Annunciator, 3-32
See also System status, 10-1
Status-cycle count, 10-2
Stop print, 10-11
Surfaces and covers, cleaning, 9-112
Symbols, 2-xv–2-xxiii, ??–2-xxiv
System configuration, 3-31
System description, 1-1
System hazards
Moving parts, 2-vi
System Status, 10-1
T
Tables, 3-10
Beckman Coulter defined chemistries, 3-10
Predefined special calculations, 3-21
Predefined special formulas, 3-21
Temperatures, 10-2
Timed urine results
Constants and factors, 3-23
Total protein cup maintenance, 9-13
Touch Screen Calibration, 11-16
U
Unload all, 10-18
Unloading samples, 1-39
Update, 3-31
See Version upgrade
UPS (Uninterruptible Power Supply), 10-13
User, 8-3
Index-5
Index
User defined reagents
Configuring, 3-5
Defining, 8-3–8-19
Deleting, 3-6
Inserting, 3-6
Minimum operating requirements, 8-1
Removing, 8-19
Setup, 3-24, 8-3
V
Valid entries, 6-5
Version information, 3-23
Version upgrade, 3-31
W
Warnings, reagent and calibration status, 4-15
Wash Concentrate II, 9-10
Waste B, pause/resume, 10-15
Wavelength
Primary, 8-6, 8-15
Secondary, 8-6, 8-15
Westgard rules, 5-2, 5-3
Wheel
See Carousel
Wrist ground strap, 9-43
Index-6
Related Documents
Synchron Clinical Systems
Chemistry Information Manual and
Synchron Clinical Systems Chemistry
Reference Manual
•
Contain specific chemistry information for
the full range of analytes available on UniCel
DxC and Synchron LX Systems.
Synchron Clinical Systems
Performance Verification Manual
•
Helps you integrate the UniCel DxC System
into your laboratory.
Synchron LX/UniCel DxC Clinical Systems
Sample Template
•
This template is used to determine if
primary tube samples have at least 264 μL of
sample available for testing. This volume of
sample is sufficient to run most 20-test
general chemistry panels.
UniCel DxC 600 and DxC 800 Synchron Clinical
Systems In-Lab Training Manual
•
Used to train laboratory personnel on
DxC 600 and 800 routine operations.
UniCel DxC 600 and DxC 800 Synchron Clinical
Systems Operator Tips
•
Provides a summary of frequently used
information about your system and the
chemistries used.
UniCel DxC Synchron Clinical Systems
Host Interface Specifications
•
Contains the necessary information to
interface UniCel DxC Systems to a
Laboratory Information System (LIS).
UniCel DxC Synchron Clinical Systems
Reference Manual
•
www.beckmancoulter.com
Contains detailed operating instructions
and supplemental maintenance and
troubleshooting guidelines for UniCel DxC
Systems. It also contains information about
the UniCel DxC Systems, such as theory of
operation, system specifications and safety
information.
© 2010 Beckman Coulter, Inc.
All Rights Reserved
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