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A13914AF
April 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
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
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
A13914AF
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:
•
Environmental Conditions Precautions
•
•
•
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
•
•
•
procedure
•
Added cleaning statement to
•
Clean Flow Cell, Cups and CC Probes/Mixers (Automated)
•
Deleted CC Probes/Mixers Cleaning (Manual Program) procedure 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
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.
vi
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
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 vii
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
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.
viii
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.
CO
2
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 xi
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.
456161-B
CAUTION
TO REDUCE RISK OF PERSONAL INJURY,
OPERATE ONLY WITH ALL COVERS IN PLACE.
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.
WASTE B
SENSOR
WASTE B
OUTLET
128
136
D. I. WATER INLET
MAX. PRESS. 100 PSI (689 kPa)
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
Safety Notice
, v
Introduction
, xxxiii
CHAPTER 1:
System Description
, 1-1
, 1-1
, 1-5
Modular Chemistry (MC) System , 1-12
Cartridge Chemistry (CC) Reagent Handling System , 1-17
, 1-21
Operation and Control Components
, 1-26
Main Screen and Program Structure , 1-27
, 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
Configuring the Chemistry Menu , 3-5
Setting the Default Sample Type , 3-13
Patient Results – Immediate Reporting Setup
, 3-14
, 3-15
, 3-16
, 3-17
Reference/Critical Ranges Setup , 3-19
, 3-19
Special Calculations Definition , 3-20
Timed Urine and Creatinine Clearance Results
, 3-23
User Defined Chemistries Setup
, 3-24
, 3-25
Maximum Sample Program Age , 3-26
Reserved Racks/Obstruct Detect
, 3-26
Disable Service Monitor , 3-27
, 3-28
Language/Keyboard Setup , 3-29
, 3-30
, 3-30
, 3-31
Status Alarm/Annunciator , 3-32
, 3-33 xxviii
CHAPTER 4:
Reagent Load/Calibration
, 4-1
, 4-12
Load a Calibrator Diskette , 4-12
, 4-13
Reagent and Calibration Status Warnings , 4-15
, 4-18
, 4-26
Calibration Acceptance Limits , 4-27
Calibrator Set Point Modifications , 4-28
, 4-29
Reprint Calibration Reports , 4-31
CHAPTER 5:
Quality Control
, 5-1
, 5-1
, 5-7
, 5-7
, 5-9
Review a Control Definition , 5-12
, 5-12
, 5-16
, 5-18
Quality Assurance Program (QAP) “Copy To Disk” Feature , 5-21
, 5-23
Contents
xxix
Contents
, 5-24
CHAPTER 6:
Sample Programming and Processing
, 6-1
, 6-2
Sample Programming and Processing
, 6-6
Additional Programming Information , 6-10
CHAPTER 7:
Results Recall
Recall Results by Sample ID , 7-2
Recall Results by Rack and Position
, 7-3
, 7-4
Recall Results by Run Date/Time
, 7-4
Display Recalled Results , 7-5
Edit Critical Rerun Result , 7-6
, 7-7
, 7-8
, 7-10
CHAPTER 8:
User Defined Reagents
, 8-1
Requirements and Precautions , 8-1
, 8-3
, 8-8
, 8-15
Determination of Extinction Coefficients
, 8-16
, 8-17
, 8-19
Expanded User Defined Chemistry Feature
, 8-20 xxx
Contents
CHAPTER 9:
Maintenance
Electronic Maintenance Log , 9-4
, 9-7
Check Chloride Calibration Span , 9-17
, 9-43
As-Needed/As-Required Maintenance
, 9-64
CHAPTER 10:
System Status and Commands
, 10-1
, 10-2
, 10-3
, 10-3
, 10-4
Hydropneumatics Subsystem , 10-4
, 10-6
, 10-7
, 10-8
, 10-8
, 10-9
Enable/Disable Modules , 10-16
, 10-18 xxxi
Contents
CHAPTER 11:
Utilities
, 11-1
, 11-1
, 11-12
, 11-12
, 11-13
, 11-16
CHAPTER 12:
Troubleshooting Calibration and Result Errors
, 12-1
, 12-2
, 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
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
Command buttons
(buttons with names on a screen)
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
)
Buttons with names are bold and use a SansSerif font.
Examples:
Select
OK
.
Select
Cancel
.
A13914AF xxxiii
Introduction
Manual Conventions
Table 1 Conventions Used in this Manual (Continued)
Convention
Function buttons
Icon buttons
Instrument buttons
Keyboard keys
Pull-down menus
Text field
Description
Function buttons are bold and use a SansSerif font.
Example:
Select
Print F10
.
Icon buttons are bold and use a SansSerif font.
Example:
Select
Samples
from the menu bar.
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 are enclosed in ( ) .
Examples:
(
X
) , ( ) , (
Tab
) , (
Enter
)
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.
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.
A13914AF 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
Installed by
Installation Category
Requirement
The DxC system is installed completely by Beckman Coulter
II
A13914AF
1-1
System Description
Operational Conditions
Clearances
Table 1.2 System Clearances
Area Affected
Left Side
Right Side
Back
Top
Front
Clearance Needed
Minimum of 6 inches (15.2 cm) clearance or 12 inches (30.5 cm) to access smart modules.
Minimum of 18 inches (45.7 cm) clearance when monitor on swing arm is in use.
Zero inches. The venting design of the system allows for "0 inch" clearance at the back.
Minimum of 22 inches (55.9 cm) from highest point of system.
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
Operating range
Frequency
BTU generated
Power connector
Requirement
200–240 VAC ± 10% (180–264 VAC)
14 A at low line, exclusive of power on surge
50/60 Hz
10,500 BTU/hour
20 A current rating, NEMA L6-20R twistlock in-line connector
1-2
A13914AF
System Description
Operational Conditions
1
Table 1.4 Power Requirements – DxC Console (PC System and Monitor)
Item
Operating range
Frequency
BTU generated
Power connector
Requirement
100–120 VAC ± 10% (90–132 VAC); 4A
OR
200–240 VAC ± 10% (180–264 VAC); 2A
50/60 Hz
1,500 BTU/hour
15 A current rating, IEC 320 standard connector
Table 1.5 Power Requirements – Okidata B4350 LED Printer
Item
Operating range
Frequency
BTU generated
Power connector
Requirement
110–127 VAC ± 10% (99–140 VAC); 3A
OR
220–240 VAC ± 10% (198–264 VAC); 1.6A
50/60 Hz
1228 BTU/hour (printing); 34 BTU/hour (standby power save)
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
Environment
Ambient temperature
Warm-up time
Relative humidity
Elevation
Specification
Indoor use only
+18°C to +32°C
30 minutes (time to reach operating temperature)
20–85% relative, non-condensing
Up to 4,200 ft (1280 m)
A13914AF
1-3
System Description
Operational Conditions
Water Requirements
Table 1.7 Water Requirements
Item
Flow Rate
Temperature
Water pressure
Specification
0.6 L/min peak flow rate, 16 L/hr minimum continuous flow rate
+15°C to +25°C
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
Organic Impurities
Total Organic Carbon (TOC)
CLSI
CLRW
500 ng/g TOC (Total Organic
Carbon) parts per billion (ppb)
Microbiological Impurities
Maximum microbial content colony forming unit (CFU/mL)
10 CFU/mL
10 M
Ω.Cm
Ionic Impurities
Minimum resistivity, megohm.centimeter
(M
Ω.Cm@25C)
Particulate & Colloid Content Purification process requirement only: water filtration using 0.22 μm pore size to remove microorganisms and particulates
Beckman Coulter Requirements
Not Applicable
10 CFU/mL
1.0 M
Ω.Cm
Purification process requirement only: water filtration using 0.22 μm pore size to remove microorganisms and particulates pH
Maximum silicate (mg/mL) SiO
2
Not Applicable
Not Applicable
Not Appiicable
Not Applicable
Other System Specifications for IEC-1010 Compliance
Table 1.9 IEC-1010 Specifications
Item
Pollution Degree
EN55011
Maximum Sound Pressure
Specification
2
Meets Class A
≤ 65 dBA average over 8 hours with covers down at 1 meter away from the instrument at +25°C
1-4
A13914AF
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)
System Description
System Components
1
A13914AF
* Equivalent to Near Infrared Particle Immuno Assay (NIPIA).
1-5
System Description
Sample Handling System
Figure 1.1 UniCel DxC 600/800 Analyzer (600 shown)
1 2
3
4 5
1. Modular Chemistry (MC) Section
2. Cartridge Chemistry (CC) Portion
3. Autoloader
A011869P.EPS
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
1
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
13 × 75
16 × 75
Rack
13 × 100
16 × 100
Accepts These Cups and Tubes
12 × 75 mm tubes
13 × 75 mm tubes
0.5 mL cups
2.0 mL cups
16 × 75 mm tubes
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 mm tubes
16 × 92 mm tubes
16.5 × 100 mm tubes
Beckman Coulter 0.5 mL Cup Insert (PN 467406)
A13914AF
1-7
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 Rack
1. Numeric Rack ID Number
2. Rack Size Label
3. Bar Coded Rack ID Label
1-8
A13914AF
System Description
Sample Handling System
1
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
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. Pushers
2. Run Button
3. Priority Load Button
4. 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
.
A13914AF
1-9
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
.
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
section, for a description of the CAUTION labels for the bar code reader.
1-10
A13914AF
System Description
Sample Handling System
1
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 Becton Dickinson VACUTAINER with
HEMOGARD
Tube Type
1-Blade Narrow CTS
Greiner VACUETTE
Sarstedt S-Monovette
Tube Size
13 × 75 mm
13 × 100 mm
16 × 100 mm
13 × 75 mm
13 × 100 mm
75 × 15 mm a
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
System Description
Modular Chemistry (MC) System
Sample Carousel
The ten-rack position Sample Carousel is a motor-driven turntable. Refer to
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
1. Liquid Level Sense Assembly
2. Sample Probe (MC)
3. Collar Wash
4. Sample Carousel
A015903P.EPS
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
1
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 CO
2
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
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
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
. 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
1. Solenoid Valve (example)
2. Cylinder 1
3. Cylinder 2
A015904P.EPS
4. Cylinder 3
5. Outlet Line (example)
6. Inlet Line (example)
1-14
A13914AF
System Description
Modular Chemistry (MC) System
1
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
4. Reference Inlet
5. DI H
2
O Inlet
A13914AF
1-15
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. Inlet Port
2. CL Electrode
3. K Electrode
4. CO
2
Reference Electrode
5. CO
2
Electrode
6. Exit Port for Waste (large tube)
7. Exit Port for Internal reference
8. Na Reference Electrode
9. Na Electrode
10. Ca Electrode
1-16
A13914AF
System Description
Cartridge Chemistry (CC) Reagent Handling System
1
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
. 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
1
4
5
1. Circuit Board (behind protective shield)
2. Reaction Cup
3. Reaction Cup Housing
A015905P.EPS
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
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
1
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
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
3
4
1
2
1. Top Positions 31–59
2. Top Bar Code Reader
3. Bottom Positions 1–30
4. Bottom Bar Code Reader
A007408P.EPS
A13914AF
1-19
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 CC Reagent Probe Area
1
2
4
3
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
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
1
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
), 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
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
.
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
1
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
4. Probe #4
5. Wash Station
A13914AF
1-23
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
and
. 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
1. Wash Concentrate Solution
2. No Foam Reagent
3. DI Water Canister
A016497P.EPS
4. Wash Solution Canister
5. Wash Concentrate Reservoir
6. Auto-Gloss
1-24
A13914AF
System Description
Hydropneumatic System
1
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
1. Waste B Exit Sump
2. Waste Exit Sump
3. DI Water Inlet On/Off
4. Waste Sump
2
5. Waste B Sump
6. DI Water Reservoir
7. Vacuum Accumulator
A015911P.EPS
A13914AF
1-25
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 DxC Push-Button Controls
Push-Button
Control Type
Run
Priority
Stop
To start the test process.
Primary Function
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.
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
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System Description
Main Screen and Program Structure
1
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
1. CTS Indicator
2. Host Indicator
3. System Status Indicator
4. Menu Bar
5. Sample Status Icons
6. Rack Status Area
7. Function Bar
E011950S.EPS
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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
Host
Printing
System Status
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."
This indicator (2) in
, 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.
The indicator appears at the middle of the operator screens. When the indicator
appears, you must reboot the DxC system to restart printing.
This indicator (3) appears on the left side of the Main screen in
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.
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System Description
Main Screen and Program Structure
1
Sample Status Indicators
Refer to
. 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
Not Programmed
Query Pending
In Progress
Aspirated
Incomplete
Complete
Status Description
Indicates a sample has been loaded without any programming associated with that
Sample ID.
Sample is waiting for specific program information to be downloaded from the host.
Sample has been identified and is currently being processed.
Indicates whether an initial aspiration of the sample has been accomplished.
Sample has some tests that are still pending.
All tests for sample have been completed.
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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 1.18 Program Structure (Main, Samples)
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Figure 1.19 Program Structure (Results, Rgts/Cal)
System Description
Main Screen and Program Structure
1
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System Description
Main Screen and Program Structure
Figure 1.20 Program Structure (QC, Setup)
1-32
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Figure 1.21 Program Structure (Setup - continued)
System Description
Main Screen and Program Structure
1
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System Description
Main Screen and Program Structure
Figure 1.22 Program Structure (Setup - continued)
1-34
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Figure 1.23 Program Structure (Utils)
System Description
Main Screen and Program Structure
1
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1-35
System Description
Main Screen and Program Structure
Figure 1.24 Program Structure (Utils – continued)
1-36
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Figure 1.25 Program Structure (Utils – continued, Status, Instr Cmd, and Help)
System Description
Main Screen and Program Structure
1
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1-37
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.
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System Description
Main Screen and Program Structure
1
Rack Status Area
These boxes,
(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.
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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...
See the log
See more pages
Print the log (present list of sample history)
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
Select...
Log F8 from the Main screen
(
Page Up
)
or
(
Page Down
)
Description of Log Fields
Table 1.16 Sample Log Fields
Field
Rack
Position (Pos)
Sample ID
Updated
Description
The rack in which the sample was run.
The position of the sample in the rack when it was run.
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.
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).
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System Description
Main Screen and Program Structure
1
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
1-41
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.
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System Description
Theory of Operation
1
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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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.
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System Description
Cartridge Chemistry: Calibration Theory
1
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries
Type
Nonblanked
Endpoint
Chemistries
FOR HIGH CALIBRATOR LEVEL:
Reaction ABS = ABS rep1
Reaction ABS = ABS rep2
(ABS rep1
+ ABS rep2
) × 0.5 = ABS avg
(hi)
FOR LOW CALIBRATOR LEVEL:
Reaction ABS = ABS rep1
Reaction ABS = ABS rep2
(ABS rep1
+ ABS rep2
) × 0.5 = ABS avg
(lo)
Formula
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
ABS avg
(hi) – ABS avg
(lo)
E014416L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × ABS avg
(hi)]
Sample values are calculated by the following equation:
(Reaction ABS × Cal Factor) + offset = sample value
Blanked Endpoint
Chemistries
IMPORTANT
For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.
FOR HIGH CALIBRATOR LEVEL:
(Reaction ABS - Blank ABS) = Delta ABS rep1
(Reaction ABS - Blank ABS) = Delta ABS rep2
(Delta ABS rep1
+ Delta ABS rep2
) × 0.5 = Delta ABS avg
(hi)
FOR LOW CALIBRATOR LEVEL:
(Reaction ABS - Blank ABS) = Delta ABS rep1
(Reaction ABS - Blank ABS) = Delta ABS rep2
(Delta ABS rep1
+ Delta ABS rep2
) × 0.5 = Delta ABS avg
(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Delta ABS avg
(hi) – Delta ABS avg
(lo)
E014417L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Delta ABS avg
(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.
1-45
System Description
Cartridge Chemistry: Calibration Theory
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Blanked Endpoint
Chemistries
(with Volume
Correction)
FOR HIGH CALIBRATOR LEVEL:
Blank Correction Factor =
Formula
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 ABS rep1
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS rep2
(Delta ABS rep1
+ Delta ABS rep2
) × 0.5 = Delta ABS avg
(hi)
FOR LOW CALIBRATOR LEVEL:
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS rep1
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS rep2
(Delta ABS rep1
+ Delta ABS rep2
) × 0.5 = Delta ABS avg
(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Delta ABS avg
(hi) – Delta ABS avg
(lo)
E014417L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Delta ABS avg
(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.
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System Description
Cartridge Chemistry: Calibration Theory
1
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Type
Nonblanked Rate
Chemistries
Formula
FOR HIGH CALIBRATOR LEVEL:
Reaction Rate = Rate rep1
Reaction Rate = Rate rep2
(Rate rep1
+ Rate rep2
) × 0.5 = Rate avg
(hi)
FOR LOW CALIBRATOR LEVEL:
Reaction Rate = Rate rep1
Reaction Rate = Rate rep2
(Rate rep1
+ Rate rep2
) × 0.5 = Rate avg
(lo)
Cal Factor (Slope) =
Cal Set Point (hi) – Cal Set Point (lo)
Rate avg
(hi) – Rate avg
(lo)
E014418L.EPS
Offset = Cal Set Point (hi) - [Cal Factor × Rate avg
(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.
1-47
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 Rate rep1
(Reaction Rate - Blank Rate) = Delta Rate rep2
(Delta Rate rep1
+ Delta Rate rep2
) × 0.5 = Delta Rate avg
(hi)
FOR LOW CALIBRATOR LEVEL:
(Reaction Rate - Blank Rate) = Delta Rate rep1
(Reaction Rate - Blank Rate) = Delta Rate rep2
(Delta Rate rep1
+ Delta Rate rep2
) × 0.5 = Delta Rate avg
(lo)
Offset = Cal Set Point (hi) - [Cal Factor × Delta Rate avg
(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
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System Description
Cartridge Chemistry: Calibration Theory
1
Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)
Formula Type
Blanked Rate
Chemistries
(with Volume
Correction)
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 Rate rep1
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate rep2
(Delta Rate rep1
+ Delta Rate rep2
) × 0.5 = Delta Rate avg
(hi)
FOR LOW CALIBRATOR LEVEL:
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate rep1
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate rep2
(Delta Rate rep1
+ Delta Rate rep2
) × 0.5 = Delta Rate avg
(lo)
Offset = Cal Set Point (hi) - [Cal Factor × Delta Rate avg
(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.
1-49
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:
R = sample response
Conc = standard or sample concentration
R
0
K c
= calculated response for a zero sample
= scale parameter a, b, c = parameters which define the nonlinear elements of the math model
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System Description
Cartridge Chemistry: Calibration Theory
1
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.
Model #2
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.
Math Model #2 is a five-parameter logit function.
Model #3
E014421L.EPS
This function cannot be solved directly for concentration. The instrument uses an iterative method to determine the sample value.
Math Model #3 is a five-parameter exponential function.
Models #4 through #7
Model #8
This function cannot be solved directly for concentration. The instrument uses an iterative method to determine the sample value.
These Models are reserved for future development.
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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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)
Quadratic
(POLY2)
Lorentz
E014476L.EPS
E014477L.EPS
Double Inflection
Model DP4
R =
K
1 + c1 a
1 conc
+
K c2 a
2
1 + conc
E011537L.EPS
E014478L.EPS
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System Description
Modular Chemistry: Calibration Theory
1
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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System Description
Cartridge Chemistry: Principles of Measurement
Table 1.19 Methodology and Modules Used with Modular Chemistries
Chemistry
Sodium
Potassium
Chloride
Carbon Dioxide
Calcium
Urea Nitrogen a
Phosphorus a
Creatinine a
Glucose
Total Protein a
Albumin a a. DxC 800 only.
Ion selective electrode (ISE)
Ion selective electrode
Ion selective electrode pH electrode
Ion selective electrode
Conductivity electrode
Colorimetric
Colorimetric
Oxygen sensor
Colorimetric
Colorimetric
Methodology Module
ISE Flow cell
ISE Flow cell
ISE Flow cell
ISE Flow cell
ISE Flow cell
Urea Nitrogen
Phosphorus
Creatinine
Glucose
Total Protein
Albumin
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
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.
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.
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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
13 × 75
16 × 75
13 × 100
16 × 100
Accepts these cups and tubes
12 × 75 mm tubes
13 × 75 mm tubes
0.5 mL cups
2.0 mL cups
16 × 75 mm tubes
13 × 100 mm tubes
0.5 mL cups
2.0 mL cups
Capillary collection tubes (use with the capillary tube adapter)
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
2
Sample Preparation by Container Type
shows how to prepare different sample containers.
Table 2.2 Preparation of Sample Containers
If running a sample from a...
Primary Tube
Then...
• 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
• 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.
Sample Cup
0.5 mL
(PN 651412)
2.0 mL
(PN 652730 or
81902)
BD Microtainer
0.5 mL
E014498L.EPS
2.0 mL
• 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.
• Place Microtainer in adapter (PN 472987).
(Refer to figure to the right.)
• Make sure there are no bubbles in sample.
• A "reserved rack" must be used.
0.5 mL Cup Insert
(PN 467406) (reusable)
A011538L.EPS
• 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.
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2-3
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 (
) 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
1. 14 mm (0.55 inch) Minimum
2. Label Placement Area
3. 20 mm (0.78 inch) Minimum
4. 7.5 Degree Maximum
4
A014600L.EPS
2-4
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Preparing Samples for Analysis
Preparing Samples for Analysis
2
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
Tubes Validated for Cap Piercing
Becton Dickinson VACUTAINER with HEMOGARD
1-Blade Narrow CTS
Greiner VACUETTE
Sarstedt S-Monovette
Size
13 × 75mm
13 × 100 mm
16 × 100 mm
13 × 75mm
13 × 100 mm
75 × 15 mm a
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
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.
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Preparing Samples for Analysis
How to Use Reserved Racks
2
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
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
Select
OK
to assign the racks.
2-8
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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
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
3
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
The new or edited user is now in the
Password Setup
screen in alphabetical order by last name.
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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 (
O
ut of
I
nstrument
R
ange).
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.
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System Setup Options
Configuring the Chemistry Menu
3
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
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
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.
A13914AF
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
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
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
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
If the control was deleted, type an operator ID of from 1–3 alphanumeric characters and press
(
Enter
)
or
(
Tab
)
.
3-8
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System Setup Options
Configuring the Chemistry Menu
3
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
)
.
3
Select Configured chemistry position number.
4
Select
Delete F6
.
3-9
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,
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
Acetaminophen
Alanine Aminotransferase
Alanine Aminotransferase (Pyridoxal-5'-Phosphate)
Albumin
Albumin (modular)
Alkaline Phosphatase
Ammonia
Amphetamines
Amylase
Antistreptolysin-O
Apolipoprotein A-1
Apolipoprotein B
Aspartate Aminotransferase
Aspartate Aminotransferase (Pyridoxal-5'-Phosphate)
Barbiturates
Benzodiazepine
Benzodiazepine
Calcium
Cannabinoid 100 ng
Cannabinoid 20 ng
Cannabinoid 50 ng
Carbamazepine
Carbon Dioxide
Cartridge Chemistry Wash Solution
Chloride
Cholesterol
Cholinesterase
Cocaine Metabolite
Complement C3
Acronym
AMPH
AMY
ASO-
ApoA
ApoB
AST
AST-
BARB
ACTM
ALT
ALT-
ALB
ALBm
ALP
AMM
BENZ
BNZG
CALC
THC
THC2
THC5
CAR
CO
2
CCWA
CL
CHOL
CHE
COCM
C3
Units
mA/min
U/L
IU/mL mg/dL mg/dL
IU/L
IU/L mA/min
μg/mL
IU/L
IU/L g/dL g/dL
IU/L
μmol/L mA/min mA/min mg/dL mA/min mA/min mA/min
μg/mL mmol/L mA/min mmol/L mg/dL
U/L mA/min mg/dL
Precision
X.XX
X
X.X
X.X
X.X
X
X
X.XX
X.X
X
X
X.X
X.X
X
X
X.XX
X.XX
X.X
X.XX
X.XX
X.XX
X.X
X
X.XXX
X
X
X
X.XX
X.X
3-10
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System Setup Options
Configuring the Chemistry Menu
3
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Table 3.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units
and Precision (Continued)
Beckman Coulter Defined Chemistry
Complement C4
C-Reactive Protein
C-Reactive Protein
C-Reactive Protein, High Sensitivity
Creatine Kinase
Creatine Kinase (N-acetyl-L-Cysteine)
Creatine Kinase-MB
Creatinine
Creatinine
Creatinine (Serum/Plasma/Urine)
Direct Bilirubin
Digoxin (Immuno Turbidimetric)
Ethanol Alcohol
Gamma (
γ ) -Glutamyl Transferase
Gentamicin
Glucose
Glucose
Haptoglobin
HDL Cholesterol (direct)
Hemoglobin A1c
Hemoglobin A1c2
Immunoglobulin A
Immunoglobulin G
Immunoglobulin M
Iron
Lactate
Lactate Dehydrogenase
Lactate Dehydrogenase
LDL Cholesterol
Lipase (random access)
Lithium
Magnesium
Methadone
Methaqualone
Microalbumin
Acronym
FE
LAC
LD
LD-P
LDLD
LIP
LI
MG
GLUCm
HPT
HDLD
HbA1c
HbA1c2
Ig-A
Ig-G
Ig-M
METD
METQ
MA
CR-S
CREm
DBIL
DIGN
ETOH
GGT
GEN
GLU
C4
CRP
C-RP
CRPH
CK
CK-
CKMB
CREA
Units
μg/dL mmol/L
IU/L
IU/L mg/dL
U/L mmol/L mg/dL mg/dL mg/dL mg/dL
%
% mg/dL mg/dL mg/dL mA/min mA/min mg/dL mg/dL mg/dL mg/dL ng/mL mg/dL
IU/L
μg/mL mg/dL mg/dL mg/dL mg/dL mg/dL
IU/L
IU/L
U/L mg/dL
Precision
X.X
X
X.XX
X.XX
X
X.X
X
X
X.X
X
X
X
X
X
X.X
X.X
X.XX
X.XX
X.X
X.X
X
X.X
X
X.XX
X.X
X.X
X.X
X.X
X.X
X.XX
X.XXX
X
X
X.X
X.X
3-11
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
Microprotein
Opiate (2000 ng/mL cutoff)
Opiate (300 ng/mL cutoff)
Pancreatic Amylase
Phencyclidine
Phenobarbital
Phenytoin
Phosphorus (modular)
Phosphorus (Serum/Plasma/Urine)
Potassium
Prealbumin
Propoxyphene
Rheumatoid Factor
Salicylate
Sodium
T-Uptake
Theophylline
Thyroxine
Tobramycin
Total Bilirubin
Total Iron Binding Capacity
Total Protein (modular - CSF)
Total Protein (modular - Serum/Plasma)
Total Protein (Serum/Plasma)
Transferrin
Triglycerides GPO
Triglycerides GPO Blanked
Urea
Urea (modular)
Urea Nitrogen
Urea Nitrogen (modular)
Uric Acid
Valproic Acid
Vancomycin
Acronym
TRFN
TG
TG-B
UREA
UREAm
BUN
BUNm
URIC
VPA
VANC
IBCT
TPm
TPm
TP
THE
T4
TOB
TBIL
PHS
K
PAB
PROX
RF
SALY
NA
TU
M-TP
OP2
OP
PAM
PCP
PHE
PHY
PHOSm
Units
mg/dL mg/dL mg/dL mmol/L mmol/L mg/dL mg/dL mg/dL
μg/mL
μg/mL
μg/mL
μg/dL
μg/mL mg/dL
μg/dL mg/dL g/dL g/dL mg/dL mmol/L mg/dL mA/min
IU/mL mg/dL mmol/L
% mg/dL mA/min mA/min
U/L mA/min
μg/mL
μg/mL mg/dL
Precision
X.X
X
X
X.X
X.X
X
X
X.X
X.X
X.X
X
X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X
X.X
X.X
X.X
X.X
X.XX
X
X.XX
X.XX
X
X.XX
X.X
X.X
X.X
3-12
A13914AF
System Setup Options
Setting the Default Sample Type
3
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:
:
A13914AF
3-13
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.
3-14
A13914AF
System Setup Options
Panels
3
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.
A13914AF
3-15
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
A13914AF
System Setup Options
Reportable Ranges Setup
3
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).
A13914AF
3-17
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 (
O
ut of
R
eportable
R
ange).
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.
3-18
A13914AF
System Setup Options
Reference/Critical Ranges Setup
3
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.
A13914AF
3-19
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.
3-20
A13914AF
System Setup Options
Special Calculations Definition
3
Beckman Coulter Predefined Special Calculations Defaults
Table 3.2 Beckman Coulter Predefined Special Calculations Defaults
Calculation
Osmolality (1)
Osmolality (2)
Anion Gap (1)
Anion Gap (2)
A/G Ratio
Indirect Bilirubin
BUN/CREA Ratio
Urea/CREA Ratio
Free Thyroxine
CREA Clearance (1)
CREA Clearance (2)
ApoA/ApoB Ratio
ApoB/ApoA Ratio
Hemoglobin A1c
Hemoglobin A1c2
Hemoglobin A1c SI
Hemoglobin A1c2 SI
Unit
None mL/min mL/sec
None
None
%
% mmol/mol mmol/mol mOsm/L mOsm/L mmol/L mmol/L
None mg/dL
None
None
Precision
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
X.X
Beckman Coulter Predefined Special Calculation Formulas
Table 3.3 UniCel DxC 600 Predefined Special Calculation Formulas
Calculation
Osmolality (1)
Osmolality (2)
Anion Gap (1) a
Anion Gap (2) a
A/G Ratio
Indirect Bili
BUN/CREA Ratio
UREA/CREA Ratio
Free Thyroxine
CREA Clearance (1)
CREA Clearance (2)
Formula
(1.86 × NA) + (GLUCm/18) + (BUN/2.8) + 9
(1.86 × NA) + (GLUCm/18) + (UREA) + 9
NA - (CL + CO
2
)
(NA + K) - (CL + CO
2
)
ALB / (TP - ALB)
TBIL - DBIL
BUN/CREA
UREA/(CREA × 0.0884)
T4 × (TU/0.342)
[(U × V)/P] × (1.73/A) reported in mL/min
[(U × V)/P] × (1.73/A) reported in mL/sec
Sample Type
Serum
Timed Urine
Timed Urine
Serum
Serum
Serum
Blood
Serum
Blood
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum
A13914AF
3-21
System Setup Options
Special Calculations Definition
Table 3.3 UniCel DxC 600 Predefined Special Calculation Formulas (Continued)
Calculation
ApoA/ApoB Ratio
ApoB/ApoA Ratio
HbA1c
HbA1c2
HbA1c SI
HbA1c2 SI
ApoA/ApoB
ApoB/ApoA
A1c/Hb × 100
A1c2/Hb2 × 100
A1c/Hb x 1000
A1c2/Hb2 x 1000
Formula
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
Osmolality (1)
Osmolality (2)
Anion Gap (1) a
Anion Gap (2) a
A/G Ratio
Indirect Bili
BUN/CREA Ratio
UREA/CREA Ratio
Free Thyroxine
CREA Clearance (1)
CREA Clearance (2)
ApoA/ApoB Ratio
ApoB/ApoA Ratio
HbA1c
HbA1c2
HbA1c SI
HbA1c2 SI
Calculation Formula
(1.86 × NA) + (GLUCm/18) + (BUNm/2.8) + 9
(1.86 × NA) + (GLUCm/18) + (UREAm) + 9
NA - (CL + CO
2
)
(NA + K) - (CL + CO
2
)
ALBm / (TPm - ALBm)
TBIL - DBIL
BUNm/CREm
UREAm/(CREm × 0.0884)
T4 × (TU/0.342)
[(U × V)/P] × (1.73/A) reported in mL/min
[(U × V)/P] × (1.73/A) reported in mL/sec
ApoA/ApoB
ApoB/ApoA
A1c/Hb × 100
A1c2/Hb2 × 100
A1c/Hb x 1000
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
3-22
A13914AF
System Setup Options
Timed Urine and Creatinine Clearance Results
3
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.
A13914AF
3-23
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.
3-24
A13914AF
System Setup Options
Bar Code Setup
3
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
A13914AF
3-25
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.
3-26
A13914AF
System Setup Options
Disable Service Monitor
3
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.
A13914AF
3-27
System Setup Options
Host Communications
Host Communications
Introduction
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
Transport
Parameter
IP Address
Port #
Serial Options TCP/IP Options
NA a
Serial or TCP/IP
NNN.NNN.NNN.NNN
NA
7 or 8
Up to 5 digits
Range: 0–65535
NA
Default
Serial
Blank
12003
Data Bits
Stop Bits
ASTM Header
3 Digit Rack Number
Device ID
Flow Control
Data Transmission Mode
Interface
1 or 2 NA
Short or Long
Selected or Not Selected (CX7 Compatible only)
0–99
Software (XON/XOFF),
Hardware (RTS/CTS) c or none
NA
Transmission OFF, Unidirectional, Bidirectional
or Bidirectional with Query
CX7 Compatible
LX20
ASTM
None, Odd or Even NA
8 b
1 b
Short
Not Selected
0
Software (XON/XOFF)
Bidirectional
CX7 Compatible
Parity
Baud Rate 300, 1200, 2400,
4800, 9600, 19200
2½, 4 or 6 minutes
Selected or Not Selected
NA
None b
9600
Query Timeout
Requery
(Automatic Requery of Host)
Query Terminator
< or > symbols
Selected or Not Selected
Host does NOT accept either
< or > symbols
2½ minutes
Not Selected
Selected
Selected 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.
3-28
A13914AF
System Setup Options
Language/Keyboard Setup
3
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.
A13914AF
3-29
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
in this chapter for instructions.
3-30
A13914AF
System Setup Options
System Configuration
3
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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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.
3-32
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System Setup Options
Auto Generation of Control
3
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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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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4-1
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
. 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
4-2
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
Load Requested
Parameters Required
Reagent Ok
Reagent Expired
Days Exceeded
0 Tests Available
Explanation
Reagent position has been requested for reagent load but the system is running.
Parameters for a reagent cartridge are missing and were not loaded when the cartridge was loaded.
No error flags present.
Reagent has exceeded shelf life stability date.
Reagent has been on system longer than acceptable.
Reagent has been used completely; reagent cartridge is empty.
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Reagent Load/Calibration
Reagent Load
4
Table 4.1 Reagent Status Messages (Continued)
Message
Level Pending
Level Sense Error n/a
Explanation
Reagent cartridge has been loaded and is waiting to be level-sensed.
Level sense check failed to properly detect reagent in one or more compartments.
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
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. Reagent Name
2. Lot Number
3. Expiration Date
4. 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
.
4-4
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Figure 4.3 DxC 800 Leftmost Compartment
Reagent Load/Calibration
Reagent Load
4
1. BUNm/UREAm
2. PHOSm
3. GLUCm
4. TPm
5. ALBm
6. CREm
7. Electrolyte Buffer
8. Electrolyte Reference
9. CO
2
Acid
Figure 4.4 DxC 600 Leftmost Compartment
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1. GLUCm
2. CO
2
Acid
3. Electrolyte Buffer
4. Electrolyte Reference
4-5
Reagent Load/Calibration
Reagent Load
Figure 4.5 DxC 600/800 Center Compartment
3
2
4-6
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)
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
.
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
4
CAUTION
To avoid contamination, do NOT touch the reagent straw.
NOTE
The No Foam container shown in
(2) is refilled by pouring a fresh bottle of No Foam
solution into the empty container on the instrument.
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
1. Lid
2. No Foam Container
3. Connector
4. Cap
A016484P.PNG
4-7
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
. 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
1
2
4
1. Reagent Name
2. Lot Number
3. Expiration Date
4. Serial Number
A016485P.EPS
4-8
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Figure 4.8 CC Reagent Information
Reagent Load/Calibration
Reagent Load
4
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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
.
•
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
.
4-9
Reagent Load/Calibration
Reagent Load
Figure 4.9 Reagent Carousel
2
3
1
1. Cartridge
2. Top Positions
3. Bottom Positions
A011871P.EPS
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.
4-10
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Reagent Load/Calibration
Reagent Load
4
•
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.
4-11
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
. 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
4
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
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
Requested
Calibrated
Cal Required
Explanation
Indicates that calibration is pending and calibrators have been identified.
Indicates that the chemistry has been calibrated and has not exceeded its calibration time period.
Appears when:
• a new cartridge is loaded.
• a user-defined cartridge is loaded.
• a non-overrideable calibration failure has occurred.
4-14
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Reagent Load/Calibration
Reagent and Calibration Status Warnings
4
Table 4.2 Calibration Status Messages (Continued)
Message Explanation
Cal Overridden
Chem Bypassed
Operator-initiated; results are based on the failed calibration.
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
Cal Timed Out
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
Indicates that calibrator values for a chemistry have exceeded calibration acceptance limits.
Indicates time remaining has exceeded the recommended calibration period.
n/a
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.
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...
THEN the Highlight is...
Red
Which Means...
The chemistry cannot be processed now.
Cal Required
Chem Bypassed
Cal Failed
Cal Timed Out
Disabled
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4-15
Reagent Load/Calibration
Request a Calibration
Table 4.3 Conditions and Highlights for Calibration Status Warnings (Continued)
IF the Calibration Status has...
Cal Overridden
Cal Time Extended
No warning condition or N/A
THEN the Highlight is...
Yellow
Which Means...
The chemistry needs attention, but the process can continue.
— 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
4
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
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
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
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Reagent Load/Calibration
Within-Lot Calibration
4
•
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
Select
Rgts/Cal
from the menu bar.
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4-19
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
.
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
4-20
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
4
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
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
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E015927S.EPS
4
Select
Cancel
to return to the
Reagent Status
and
Calibration Status
screens.
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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 w ws
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.
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.
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 number as a cartridge with previous within-lot calibration, the new cartridge automatically receives the correct calibration status; calibration is not necessary.
the calibrator set point is modified, the lot number of the reagent is new to the system, within-lot calibration factor is lost and the calibration status becomes Cal Required. This does not apply to the slope and offset adjustment.
calibration status is Cal Required for all cartridges of that lot on the system.
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Reagent Load/Calibration
Enzyme Validator
4
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
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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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
4
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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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
4
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
Select
Close
to exit the screen.
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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
4
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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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.
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
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.
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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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.
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.
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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:
A13914AF
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.
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A13914AF
Quality Control
Quality Control
5
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.
•
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
ACCEPT/REJECT CHART
1
2S
YES
NO
IN CONTROL ACCEPT RUN
1
3S
NO
2
2S
NO
R
4S
YES YES YES
OUT - OF - CONTROL REJECT RUN
NO
NO
4
1S
NO
YES
EVALUATE
10
X
YES
E015001L.EPS
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5-3
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
5
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.
5-5
Quality Control
Define a Control
9
Type the following information in the appropriate fields for all chemistries shown:
Field Description
QC File Number 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
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
5
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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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
Select
Control F5
.
5-8
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Quality Control
Edit a Control Definition
5
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
5
4
Type the following information in the appropriate fields for all chemistries shown:
Field Description
QC File Number 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
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
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
5
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.
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
5
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 Inter-
Laboratory 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
To exit the
QC Summary
dialog box, select
Done F10
.
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5-15
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
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
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.
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
5
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
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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Quality Control
Archive QC
5
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
1
Select
QC
from the menu bar.
2
Select
Archive F8
.
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Quality Control
Review Archived Data
5
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
5-26
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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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6-1
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
6
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
, 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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6-3
Sample Programming and Processing
Identify Samples
Table 6.1 Sample Status Designations
Sample Status
In Progress
Incomplete
Complete
Reserved for Cal
Sample Required
Rerun
Removed
Manual Assign
Meaning
Sample has been identified and is currently being sampled for programmed tests.
Sample has completed all tests possible and has some tests which are still pending.
All tests have been completed.
Rack/Position assigned to a calibrator.
Sample is programmed but not yet run by the system.
Sample has been requested for rerunning.
Sample has been unloaded but some tests are still being processed.
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
6
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
Sample ID
Other
These are Valid ASCII
Character Codes...
33 thru 126
32 thru 175
Except for These Invalid Characters and
Character Codes...
A space and $ , ; * ? [ ] \^ | &
ASCII Character Codes 44 and 127
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6-5
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
6
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
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
A13914AF
Sample Programming and Processing
Sample Programming and Processing
6
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
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
6
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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6-11
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 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.
6
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,
, 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.
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Sample Programming and Processing
Clear Samples
6
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
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.
Deletion Criteria
Sample ID
Range of Sample IDs
(Refer to
in this chapter for additional information.)
Time/Date Programs Created
Rack/Position(s)
Procedure for Sample Clearing
• Type the Sample ID(s) to be cleared. Single and multiple IDs may be cleared. Use a comma (,) to separate a list of IDs.
• Type the first Sample ID in the From field.
• Type the last Sample ID in the To field.
• Type the time and date range of samples to clear.
• 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.
4
Select
OK
to continue clearing. A confirmation screen appears.
OR
Select
Cancel
to retain sample programs.
6-14
A13914AF
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.
7-2
A13914AF
Results Recall
Recall Results by Rack and Position
7
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 ,
in this chapter.
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7-3
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
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.
7-4
A13914AF
Results Recall
Display Recalled Results
7
Table 7.1 Date and Time Formats with Recall Results
Field
Date
Time
(12-hour format)
Time
(24-hour format)
Entries
1–12 mm
1–31 dd
0–99 yy
1–12 hh
0–59 mm
AM/PM
0–23 hh
0–59 mm
Notes
• An entry in the From field is required.
• If only a From date is entered, the results are recalled for that date.
• The time format is defined in Setup as 12-hour or 24-hour.
• The 12-hour default is AM.
• 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.
A13914AF
7-5
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.
7-6
A13914AF
Results Recall
Print Recalled Results
7
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
From the
Recall Results By
dialog box, select the results to be viewed, as described previously in this chapter.
A13914AF
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
7-8
1
Recall the results of the desired sample (use any of the Results Recall criteria described in the previous sections).
A13914AF
A13914AF
Results Recall
Absorbance Versus Time
7
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
.
6
To output the plot for the next chemistry:
•
Select
Next
.
7
To output the plot for the previous chemistry:
•
Select
Prev
.
7-9
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
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
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
Maximum Fill Volume
Minimum Fill Volume
Compartment A
110 mL
6 mL
Compartment B
18 mL
1 mL
Compartment C
4 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
A13914AF
User Defined Reagents
User-Defined Reagent Setup
8
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
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
Endpoint 1
Endpoint 2
Endpoint 3
Endpoint 4
Endpoint 5
Rate 1
Rate 2
Rate 3
Rate 4
Rate 5
Description
Blank absorbance is not subtracted from Reaction 1 absorbance.
Blank absorbance is subtracted from Reaction 1 absorbance.
Blank absorbance is volume corrected and then subtracted from Reaction 1 absorbance.
Blank absorbance is subtracted from Reaction 2 absorbance.
Reaction 1 absorbance is subtracted from Reaction 2 absorbance.
Blank rate is not subtracted from Reaction 1 rate.
Blank rate is subtracted from Reaction 1 rate.
Blank rate is volume corrected and then subtracted from Reaction 1 rate.
Blank rate is subtracted from Reaction 2 rate.
Reaction 1 rate is subtracted from Reaction 2 rate.
8-4
A13914AF
User Defined Reagents
Chemistry Parameters
8
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
2. mg/L
3. g/dL
4. g/L
5. mmol/L
6. μmol/L
7. mEq/L
8. nKat/L
9. μKat/L
10. IU/L
11. μg/mL
12. ng/mL
13. μg/dL
14. μg/L
15. nmol/L
16. U/L
17. other
18. %
19. mA
20. mA/min
21. IU/mL
22. U/mL
23. Rate
24. ng/dL
25. μIU/mL
26. mIU/mL
27. Ku/L
28. nIU/dL
29. mIU/L
30. positive
31. negative
32. pg/mL
33. pg/dL
34. pmol/L
35. %Uptake
36. %GHb
37. %A1c
38. GPL
39. MPL
40. APL
41. mg/mL
42. ng/L
43. RLU
44. S/CO
45. AU/mL
46. AU/L
47. mAU/L
48. mAUL/mL
49. (i) SI
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
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 nm a 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
8
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
(e
1
– e
2
)
E014426L.EPS
where: e
1 e
2
=
=
The extinction coefficient of the chromophore at the primary wavelength.
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.
S.V.
= Total reaction volume (sample plus reagent, μL)
= 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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8-7
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
8
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
User Defined Reagents
Processing Parameters
Figure 8.1 Timing Chart
DxC 600/800 Timing Chart
3 to 6 minutes
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
8-10
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User Defined Reagents
Processing Parameters
8
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
Start Read
End Read
Allowable Entry
-180 to 1704 seconds, except 0
-180 to 1720 seconds, except 0
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8-11
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
Start Read
End Read
Allowable Entry
1 to 1704 seconds
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 Test a
Start Read
End Read
1 to 1704 seconds
1 to 1720 seconds
1 to 1604 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.
8-12
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User Defined Reagents
Error Detection Limits
8
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
Lower Limit
Upper Limit
Allowable Entry
0.000 to 99999.999
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
High Limit
Mean Deviation
-1.500 to 2.200
-1.500 to 2.200
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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8-13
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
High Limit
Mean Deviation
-1.500 to 2.200
-1.500 to 2.200
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 Rate a
Delta Abs
-99.999 to 99.999
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
8
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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8-15
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
8
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: e
2
= e
1
× R where: e
2 e
1
= Extinction coefficient at the secondary wavelength
=
Extinction coefficient at the primary wavelength a
R =
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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8-17
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.
8-18
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User Defined Reagents
User Defined Reagent Removal
8
•
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
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.
5
Select
Define F1
.
6
Select
UDR+ F3
.
8-20
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User Defined Reagents
Expanded User Defined Chemistry Feature
8
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.
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.
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8-21
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
A13914AF
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
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 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
A13914AF
Maintenance
Overview
9
•
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
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
9-4
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Maintenance
Electronic Maintenance Log
9
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
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 Maintenance
,
•
Log F2
.
2
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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9-5
Maintenance
Electronic Maintenance Log
9-6
•
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
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.
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Maintenance
Twice Weekly Maintenance
9
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.
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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9-7
Maintenance
Twice Weekly Maintenance
9-8
•
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).
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 Chem Reps Fluid
XXX
Sample
Position
1
2
3
4
K
K
CCWA
K
K
15
5
10
15
5
Diluted Clenz Solution
Saline
Saline
Sodium Hypochlorite
Saline
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Maintenance
Weekly Maintenance
9
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
Clean Total Protein and Albumin Cup Modules (DxC 800 Only)
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9-9
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
.
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,
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
9
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
A13914AF
3
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.
9-11
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
9
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.
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
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
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
9
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
9-15
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)
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.
6
Select
Close
to exit the Result window after cleaning is completed.
7
Select
Close
to exit the procedure.
9-16
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Maintenance
Check Chloride Calibration Span
9
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
.
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
Adjust the Fluid Level of the Alkaline Buffer Damper Assembly
BUNm/UREAm Electrode Maintenance (DxC 800 Only)
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.
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
. The locking pin is located on the right side of the ISE module on DxC 600
Systems.
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9-17
Maintenance
Monthly Maintenance
Figure 9.7 DxC 800 ISE Module
9-18
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 CO
2
Alkaline Buffer
.
•
Type
10
in the
Number of primes to repeat
field.
•
Select
Start Prime
. Reagent line is drained of old reagent.
5
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
9
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
,
•
Load F1
.
9-19
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
9-20
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
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.
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Maintenance
Monthly Maintenance
9
16
Calibrate the CO
2
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
A13914AF
A015938P.EPS
NOTE
The damper should be positioned so that the output line #29 (2)
, 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 CO
2
Alkaline Buffer
.
9-21
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
9
10
Prime the alkaline buffer three times.
•
Select:
—
Utils
from the menu bar,
—
1 Prime
,
—
MC F4
,
—
ISE CO
2
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
ALBm a
, BUNm/UREAm a,
GLUCm a,b
, PHOSm a
CREm a
, TPm a
Prepare
10% cleaning solution
By Diluting
One part Wash Concentrate II with nine parts deionized water.
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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9-23
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
9
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
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
9-26
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.
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Maintenance
Monthly Maintenance
9
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
1. Retainer Nut
2. Retainer
3. Electrode
4. Quad-Ring
9
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.
9-27
Maintenance
Monthly Maintenance
Figure 9.16
9-28
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
.
A13914AF
Maintenance
Monthly Maintenance
9
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/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
)
.
A13914AF
9-29
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
9
1
Carefully replace MC cover over reaction cup modules and tighten screws.
IMPORTANT
While the ISE cover is removed, for maximum efficiency, 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
in the beginning of this chapter.
Gently but thoroughly wipe the outside of both mixers (1) and (2) of
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
A13914AF
1. CC Sample Mixer
2. CC Reagent Mixer
9-31
Maintenance
Monthly Maintenance
Replace CTS Blade (1-Blade Narrow CTS Option)
. 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
9-32
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
The instrument prepares for blade replacement, then the Maintenance pop-up confirmation window appears.
A13914AF
A13914AF
Maintenance
Monthly Maintenance
9
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
9-33
Maintenance
Monthly Maintenance
4
Refer to
.
•
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
9-34
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.
A13914AF
A13914AF
Maintenance
Monthly Maintenance
9
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.
9-35
Maintenance
Two-Month Maintenance
Two-Month Maintenance
Replace CTS Blade/Wick (1-Blade Thick CTS Option)
Replace CTS Blade/Wick (1-Blade Thick CTS Option)
. 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
.
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
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
A007367P.EPS
9-36
A13914AF
A13914AF
Maintenance
Two-Month Maintenance
9
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
9-37
Maintenance
Two-Month Maintenance
4
Refer to
.
•
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
A13914AF
Maintenance
Two-Month Maintenance
9
5
.
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
3
1
2
A011872P.EPS
6
.
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
9-39
Maintenance
Two-Month Maintenance
7
Refer to
.
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
.
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
9
.
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
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
.
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
Close all compartment doors.
9-42
A13914AF
Maintenance
Three-Month Maintenance
9
Three-Month Maintenance
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
in the beginning of this chapter.
Figure 9.27 CC Reagent Syringe (500 μL)
A015942P.EPS
A13914AF
9-43
Maintenance
Three-Month Maintenance
Figure 9.28 MC and CC Sample Syringes (100 μL)
1
3
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 Maintenance
,
•
7 Syringe Rod Replacement
.
2
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
A13914AF
Maintenance
Three-Month Maintenance
9
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
5
Unscrew the round plunger end (1).
Figure 9.30
1
A011874P.EPS
9-45
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
9-46
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.
A13914AF
A13914AF
Maintenance
Three-Month Maintenance
9
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
1
Select
Instr Cmd
from the menu bar.
2
Select
1 Home
.
3
All instrument parts return to their home positions.
9-47
Maintenance
Four-Month Maintenance
Four-Month Maintenance
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
ALBm, BUNm/UREAm, GLUCm a
,
PHOSm
CREm, TPm
10% cleaning solution
1N HCL
By Diluting
One part Wash Concentrate II with nine parts deionized water.
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
9
A13914AF
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.
9-49
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)
, 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
9
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.
A13914AF
* Only the GLUCm cup module is on DxC 600 Systems.
9-51
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 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
. 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.
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9
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.
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
in this section.
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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
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Maintenance
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9
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 (
).
•
Chloride Electrode (or
Replace the Chloride Electrode Tip
)
•
CO
2
Measuring Electrode (
•
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
in the beginning of this chapter.
1
Disconnect the electrode cable from potassium connector (1) and calcium connector (2).
Figure 9.36
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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
9-56
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.
A13914AF
Maintenance
Six-Month Maintenance
9
Figure 9.39
A13914AF
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.
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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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9
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
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9-60
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
Remove the ISE module and MC module covers.
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Maintenance
Six-Month Maintenance
9
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
A13914AF
4
Separate the sensor from retainer nut. Discard the old sensor and gasket.
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9-62
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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Maintenance
As-Needed/As-Required Maintenance
9
13
Select
Cancel
to return to the Maintenance menu.
14
Reinstall the MC module and ISE module covers.
15
Proceed to the
in the Monthly Maintenance section of this chapter
As-Needed/As-Required Maintenance
Replace the Chloride Electrode Tip
Replace the Sodium Measure/Reference Electrode
Clean the CO2 Alkaline Buffer Lines
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
Decontaminate the Sample Racks
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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 E-
Maintenance (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.
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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9
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
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
A13914AF
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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
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9
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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Maintenance
As-Needed/As-Required Maintenance
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
9-68
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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Maintenance
As-Needed/As-Required Maintenance
9
4
Lower the electrode face (2) into the soaking solution until only the tip is covered by the soaking solution (1).
Figure 9.47
A13914AF
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
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,
•
2 Maintenance
,
•
3 ISE Service
.
9-69
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
9-70
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9
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
As-Needed/As-Required Maintenance
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
9-72
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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Maintenance
As-Needed/As-Required Maintenance
9
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 CO
2
Membrane
The permeability of the CO
2
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 CO
2 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
in the beginning of this chapter.
Remove the Old CO
2
Membrane
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
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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 CO
2
Measuring Electrode cable (1).
Figure 9.52
1
A010980P.EPS
9-74
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Maintenance
As-Needed/As-Required Maintenance
9
5
Locate the CO
2
measuring electrode. Place absorbent tissue beneath the CO
2
electrode port.
Using hemostats, clamp off reagent Lines #33 (1) and #32 (2) as closely as possible to the CO
2 electrode. (Line #32 connects as a loop to the CO
2
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
9-75
Maintenance
As-Needed/As-Required Maintenance
Prepare the New CO
2
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
9-76
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Maintenance
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9
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
9-77
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 CO
2
electrode. This ensures a proper fluid seal when the electrode is installed in the flow cell.
Figure 9.60
9-78
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9
Reinstall the CO
2
Measuring Electrode
CO
2
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 CO
2
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
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
As-Needed/As-Required Maintenance
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
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.
9-80
* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).
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Maintenance
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9
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
9-81
Maintenance
As-Needed/As-Required Maintenance
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
9-82
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As-Needed/As-Required Maintenance
9
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
A13914AF
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.
9-83
Maintenance
As-Needed/As-Required Maintenance
13
Using the syringe filled with 10% bleach solution, connect the syringe tip over the flow cell exit port #23 (1).
Figure 9.66
9-84
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.
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
A13914AF
20
Reattach lines #18, #24, #23, #26, and #15 to the EIC ports. Refer to
.
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.
9-85
Maintenance
As-Needed/As-Required Maintenance
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 CO
2
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
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).
9-86
A13914AF
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
5
Prime the ISE CO
2
Alkaline Buffer 20 times.
•
Select:
—
Utils
from the menu bar,
—
1 Prime
,
—
MC F4
,
—
ISE CO
2
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 CO
2
Alkaline Buffer 25 times as follows:
•
Select the
ISE CO
2
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 CO
2
Alkaline Buffer 15 times as follows:
•
Select the
ISE CO
2
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 CO
2
Alkaline Buffer 5 times as follows:
•
Select the
ISE CO
2
Alkaline Buffer
check box.
•
Type
5
in the
Number of primes to repeat
field.
•
Select
Start Prime
. Wait for prime cycles to finish.
9-87
Maintenance
As-Needed/As-Required Maintenance
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 CO
2
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
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.
9-88
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
A13914AF
7
Using four to five cotton swabs soaked with deionized water, clean the inside of the lower drain and the top of drain.
9-89
Maintenance
As-Needed/As-Required Maintenance
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.
9-90
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
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
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.
A13914AF
9-91
Maintenance
As-Needed/As-Required Maintenance
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
9-92
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
Re-attach line #27 to the front of the flow cell. Remove the syringe and empty the contents. Fill the syringe with ISE Buffer.
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
A13914AF
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.
9-93
Maintenance
As-Needed/As-Required Maintenance
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 CO
2
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.
9-94
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
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
). (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
A13914AF
1. Line 23
9-95
Maintenance
As-Needed/As-Required Maintenance
9-96
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.
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
in the beginning of this chapter.
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.
A13914AF
9-97
Maintenance
As-Needed/As-Required Maintenance
Figure 9.73
1
2
9-98
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.
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
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
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.
A13914AF
9-99
Maintenance
As-Needed/As-Required Maintenance
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
Select:
•
Instr Cmd
.
•
1 Home
.
2
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
·
Prime the CC Reagent Delivery Subsystem
9-100
A13914AF
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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.
9-101
Maintenance
As-Needed/As-Required Maintenance
Figure 9.75 CC and MC Sample Probe
1
2
3
5
4
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
9-102
1. Reagent Probe
2. Collar Wash
3. Waste Port
A007376L.EPS
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.
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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
At the completion of this procedure, the Maintenance menu appears.
A13914AF
9-103
Maintenance
As-Needed/As-Required Maintenance
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).
9-104
A13914AF
Maintenance
As-Needed/As-Required Maintenance
9
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,
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.
A13914AF
9-105
Maintenance
As-Needed/As-Required Maintenance
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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9
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
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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9
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
Select
Close
at the completion of this procedure to exit the
Result
pop-up window.
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9
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
A13914AF
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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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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9
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
3
1
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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9
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
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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:
1
Select
Utils
from the menu bar.
2
Select
2 Maintenance
.
3
Select
1 CTS Blade Replacement.
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9
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
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
Lift and remove the Cap Piercer Cover and set it aside.
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Maintenance
As-Needed/As-Required Maintenance
Remove the Blade Assembly and Wick Clip Assembly
The Cap Piercer Assembly is now visible as shown in
. Remove the Blade Assembly and
Wick Clip Assembly as follows:
1
. 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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9
2
. 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
Put the Blade Assembly onto a plastic tray. DO NOT touch the Blade.
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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
. 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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9
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
. 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
. 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
3
Put the Blade Assembly back on the same tray.
A007561P.EPS
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9
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
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
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.
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
7
Install the Cap Piercer Cover (2). Tighten the two cover Screws (1) with a screwdriver. Refer to
.
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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9
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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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
.
•
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
9-126
1. Plastic Cover
2. Pump Tube Fitting
3. Pump Tube Fitting
4. Pinch Clamp
5. Pinch Clamp
6. Pump Roller Mechanism
4
Discard the used tube in a bio-hazardous waste container.
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Maintenance
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9
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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As-Needed/As-Required Maintenance
9-128
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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
Error
Warning
OK
Description
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.
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.
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
1
Select
Status
from the menu bar.
2
Select the
Count
tab. A summary of the monitored areas appears.
10-2
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System Status and Commands
Temperatures
10
Cycle Count Description
Table 10.2 Counters
Counter
Modular Chem
ISE
Cartridge Chem
Blade Count
CTS Count
Sample Count
Description
Each result for each cup is counted separately. Even if ORDAC is triggered, the counter only increments for the one result.
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.
Each cartridge chemistry reagent dispensed is counted.
• 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
.
The total number of caps pierced by the Cap Piercer Module.
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
Select
Status
from the menu bar.
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10-3
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
10
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.
1
Select
Status
from the menu bar.
2
Select the
SmrtMdl
tab. A summary of the monitored areas appears.
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10-5
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
A13914AF
System Status and Commands
CTS Tracking
10
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
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
A13914AF
System Status and Commands
Pause
10
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
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...
Imminent danger to a person or the instrument.
Reagent needs to be loaded while the system is running.
Sample on the sample carousel is needed immediately.
Instead of Pause...
Press the STOP button or turn off power.
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.
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
10-10
A13914AF
System Status and Commands
Stop Print
10
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
1
Select
Instr Cmd
from the menu bar.
2
Select
3 Stop Print
.
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10-11
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
A13914AF
System Status and Commands
Shutdown
10
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
A13914AF
10-13
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.
10-14
A13914AF
System Status and Commands
Pause/Resume Waste B
10
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
•
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.
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
Select
Instr Cmd
from the menu bar.
A13914AF
10-15
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.
10-16
A13914AF
System Status and Commands
Enable/Disable Modules
10
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
Select
Instr Cmd
from the menu bar.
A13914AF
10-17
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.
10-18
A13914AF
System Status and Commands
Unload All
10
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
All racks on the sample carousel are removed and the Instrument Command window closes. An empty sample carousel is shown on the
Main
screen.
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10-19
System Status and Commands
Unload All
10-20
A13914AF
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
Reagent Delivery Subsystem
Sample Delivery Subsystem
Cuvette Wash Station
Function
Washes the reagent probes and mixer, primes the reagent syringe.
Washes the CC sample probe and mixer, primes the sample syringe.
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
Fill canisters and reservoirs
CC Drain waste sump
CC Drain Waste B sump
Drain gravity drain sump
Function
Fills water, wash, and diluted wash.
Drains waste sump and exit sump.
Drains Waste B sump and exit sump.
Drains the gravity sump.
A13914AF
11-1
Utilities
Prime
Table 11.3 A Prime for the Cups of the MC Subsystems
MC Subsystems
Cups
ALBm (DxC 800 only)
CREm (DxC 800 only)
GLUCm (DxC 600 and DxC 800)
PHOSm (DxC 800 only)
TPm (DxC 800 only)
BUNm/UREAm (DxC 800 only)
Function
Primes Albumin Reagent and/or water.
Primes Creatinine Reagent and/or water.
Primes Glucose Reagent and/or water.
Primes Phosphorus Reagent and/or water.
Primes Total Protein Reagent and/or water.
Primes BUN/UREA Reagent and/or water.
Table 11.4 A Prime for Other Components of the MC Subsystems
MC Subsystems
ISE Module (all)
Electrolyte Buffer
Electrolyte Reference
EIC Wash
ISE CO
2
Alkaline Buffer
Reference and Acid
Sample Delivery Subsystem
Function
Primes all reagents used by the ISE module.
Primes Electrolyte Buffer Reagent.
Primes Electrolyte Reference Reagent.
Primes DI water to the EIC.
Primes the CO
2
electrodes with Alkaline Buffer Reagent.
Primes both Electrolyte Reference and CO
2
Acid Reagent.
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
A13914AF
Utilities
Prime
11
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)
.
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.
A13914AF
11-3
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
.
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.
11-4
A13914AF
Utilities
Prime
11
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
.
A13914AF
11-5
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
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
A13914AF
Utilities
Event Log
11
Event Log Classes
Table 11.6 Event Log Classes
Class Number
6
7
4
5
1
2
3
10
11
8
9
Event Log
Chemistry Errors
Motion Errors
Status Monitor Errors
Other Instrument Errors
Instrument Events
LIS Comm. Errors
Other Console Errors
Input Device Events
Other Console Events
Sample Processing Events
Deleted Results
# of entries
10,000
10,000
10,000
10,000
120,000
180,000
10,000
15,000
10,000
60,000
10,000
Event Information
Table 11.7 Information in the Event Log
Event information
Number
Class
Date
Time
Description
Definition
Sequential number identifying the "order", with number one representing the most recent entry.
Number corresponding to the 1-10 event classes listed on the Event Log main screen (for example, Instrument Events).
The Month, Day, and Year the event occurred.
The time the event occurred in Hours, Minutes, and Seconds.
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
)
.
A13914AF
11-7
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
Display
Copy
Option
Time
Clear
Done
Description
Display Events - for reviewing events on the screen.
Copy to diskette - for saving events to a disk as a permanent record, for viewing on another system or sending to Beckman Coulter.
Date and Time selection - for selecting events for a specified date and time period.
Clear Events - for removing unwanted event information. To clear information, select the event class(es) to be deleted and select the clear confirmation window.
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.
To exit.
Show Events
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
. This will print the entire selection, not just the page currently shown.
11-8
A13914AF
Utilities
Event Log
11
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
Upon completion, "Copy Done" briefly appears before the screen returns to the
Event Log
dialog box.
A13914AF
11-9
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
. This will print the entire selection, not just the page currently shown.
11-10
A13914AF
Utilities
Event Log
11
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
from the
Event Log
dialog box.
OR
Select
from the
Display Events
dialog box.
To stop the printer,
•
Select
Instr Cmd
from the menu bar,
•
Select
3 Stop Print
.
A13914AF
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
A13914AF
Utilities
Backup/Restore
11
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.
A13914AF
11-13
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
11
A13914AF
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
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
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
1-Blade CTS option
1-Blade Narrow CTS,
70% isopropyl alcohol,
A
AccuSense glucose sensor
Drain reaction cup for sensor, 9-58 ,
Prepare prior to replacement, 9-60
Replace, six-month,
,
Air filters
Alarm/Annunciator
Alignment
See UniCel DxC Synchron Clinical Systems
Reference Manual
Alkaline buffer damper assembly
Adjust fluid level,
Fluid level high,
Fluid level low,
Replace alkaline buffer reagent, 9-18
Archive QC Data,
Auto ORDAC,
Auto serum index,
Autoloader,
B
Backup,
Alignment data,
Hand-held (MC),
Sample,
Boot
Full boot,
Buttons,
C
Calibration
Acceptance limits,
Bypass,
Calibrator set point modifications, 4-28
Enzyme validator,
Extending calibration time, 4-26
Failure messages,
Formulas
Endpoint and first-order, 1-44 –
Reprint calibration report,
Request
Canceling a calibration request, 4-18
Status,
Within-lot calibration,
Enabling within-lot calibration, 4-19
Index-1
Index
Index-2
Frequency,
Cap piercer
1-Blade Narrow CTS,
1-Blade Narrow CTS option, 9-32
1-Blade Thick CTS option,
Carousel,
Cartridge chemistries (CC),
Spectrophotometric methods,
CC — Cartridge chemistry,
CC reagent mixer, clean,
CC sample mixer, clean,
CC sample probe, reagent probes and mixers
Automated cartridge chemistry probe cleaning
CCWA — Cartridge chemistry wash solution,
Chemistry parameters,
Chemistry print name, defining, 3-6
Chemistry, configuring,
Clearing chemistries,
Chloride Electrode tip, Replace,
Closed Tube Sampling
CO
2
alkaline buffer reagent straw and line, bleaching
CO
2
measuring electrode membrane, 9-73
Replace,
Wrinkled,
Constituent code,
Control,
–
Bar codes,
Constituent code,
Definition,
Deleting,
Fields,
File number,
Printing,
QC chart,
QC file list,
QC summary,
Creatinine clearance results
Critical Result Rerun,
CTS — Closed Tube Sampling,
CTS (Closed Tube Sampling)
1-Blade Narrow CTS option,
1-Blade Thick CTS option,
Blade count,
CTS Count,
CTS Auto-Gloss,
CUPs lamp and sensor calibration, 9-29
Cuvette reaction system,
Cuvette washer probe, inspect
Blocked probe,
Cuvette washing
Cuvette water blank status, 10-6
Cuvette wiper
Reinstall,
Cuvettes
Automated wash all cuvettes, 9-109
D
Sample programs,
Date/time setup,
Deleted results,
Deleting,
Control,
Critical result rerun,
QC data point,
Index
Drugs of abuse testing (DAT),
E
Editing
EIC — Electrolyte injection cup, 9-2
–
ISE service,
Electrolyte injection cup (EIC), 1-15
,
Enzyme validator,
Enzyme verification,
Error detection
Error detection limits,
Exit check criteria,
,
Expanded user defined chemistry feature,
Extinction coefficients,
Immediate reporting,
Instrument commands,
Intended use,
ISE — Ion selective electrode (flow cell
ISE drain cleaning, six-month
Drain top,
Drip screen,
ISE reference solution,
K
Keyboard,
L
Labels,
Language/keyboard, selection, 3-29
Levey-Jennings,
Log fields,
LPIA (large particle immuno assay)
I
F
Failure messages, calibration,
File number,
Flow cell flush kit,
Flow cell, flushing
ISE service,
–
H
Home,
Host specifications
See Host Interface Specifications Manual (P/
N A16150)
Hydropneumatic system,
Icons,
M
,
Main screen and program structure,
Maintenance,
Manual
Conventions,
Scope,
Manual assignments,
MC — Modular chemistry,
MC components, reassemble,
Modem,
Modular chemistries (MC),
Basic components,
Modular reagents
Index-3
Index
Index-4
Check levels,
Modules,
Modules, enable/disable,
N
O
ORDAC,
Auto ORDAC,
P
Panels,
Patient results
Critical results rerun,
PHOSm, cleaning precipitate
Protein precipitate,
Photometer assembly,
Post run summary,
Potassium and calcium electrode tips
Replacing, six-month
ISE service,
Removing/installing,
Power Subsystem Status,
Pre run summary,
,
Precautions,
–
Prime,
Printers,
Printing,
Control,
Data,
QC chart,
Priority
Position,
Priority load,
Probes, clean,
Batch,
Manual assignments,
ORDAC,
Rack/cup position,
Sample ID,
Sample status,
Pushers,
Q
QAP Disk,
Quad-ring
CO
2
measuring electrode,
Potassium and calcium electrode,
,
Quality Assurance Program (QAP)
Copy to disk feature,
Quality control (QC),
Printing QC bar code assignments,
QC chart,
QC file list,
Displaying,
R
Status,
Reaction type,
Reagent handling system, CC, 1-17
Reagent parameters,
Loading,
Reagent status
Sorting reagent status
Days left,
Tests left,
Reagent syringe,
See also Sample and reagent syringes,
replacing three-month
Recalling results
Index
Printing,
Replicates,
Reports,
Reserved racks, assigning,
Reset,
Restore,
,
Retainer nut,
Review results,
Reviewing,
S
Sample
Handling system,
Programming
Type
Default,
Sample and reagent syringes, replacing threemonth
Plunger rods,
Sample syringe,
MC sample syringe,
Serum index
Service
See also Metering Manual (P/N 967259)
Setup,
Setup
Screens,
Silicone compound,
Smart modules
Status,
Sodium Azide preservative,
Software version,
Specifications, system
Statistical summary report,
Status
Alarm/Annunciator,
See also System status,
Status-cycle count,
Stop print,
Surfaces and covers, cleaning,
System hazards
Moving parts,
System Status,
T
Tables,
Beckman Coulter defined chemistries,
Predefined special calculations,
Predefined special formulas,
Timed urine results
Constants and factors,
Total protein cup maintenance,
Touch Screen Calibration,
U
Update,
UPS (Uninterruptible Power Supply),
User,
Index-5
Index
User defined reagents
Defining,
Deleting,
Inserting,
Minimum operating requirements,
Removing,
Setup,
V
Version information,
Version upgrade,
W
Warnings, reagent and calibration status,
Wash Concentrate II,
Waste B, pause/resume,
Wavelength
Primary,
Secondary,
Westgard rules,
Wheel
Index-6
www.beckmancoulter.com
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
•
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
A13914AF
April 2010
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
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
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
Safety Notice
, v
Introduction
, xxxiii
CHAPTER 1:
System Description
, 1-1
, 1-1
, 1-5
Modular Chemistry (MC) System , 1-12
Cartridge Chemistry (CC) Reagent Handling System , 1-17
, 1-21
Operation and Control Components
, 1-26
Main Screen and Program Structure , 1-27
, 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
Configuring the Chemistry Menu , 3-5
Setting the Default Sample Type , 3-13
Patient Results – Immediate Reporting Setup
, 3-14
, 3-15
, 3-16
, 3-17
Reference/Critical Ranges Setup , 3-19
, 3-19
Special Calculations Definition , 3-20
Timed Urine and Creatinine Clearance Results
, 3-23
User Defined Chemistries Setup
, 3-24
, 3-25
Maximum Sample Program Age , 3-26
Reserved Racks/Obstruct Detect
, 3-26
Disable Service Monitor , 3-27
, 3-28
Language/Keyboard Setup , 3-29
, 3-30
, 3-30
, 3-31
Status Alarm/Annunciator , 3-32
, 3-33 xxviii
CHAPTER 4:
Reagent Load/Calibration
, 4-1
, 4-12
Load a Calibrator Diskette , 4-12
, 4-13
Reagent and Calibration Status Warnings , 4-15
, 4-18
, 4-26
Calibration Acceptance Limits , 4-27
Calibrator Set Point Modifications , 4-28
, 4-29
Reprint Calibration Reports , 4-31
CHAPTER 5:
Quality Control
, 5-1
, 5-1
, 5-7
, 5-7
, 5-9
Review a Control Definition , 5-12
, 5-12
, 5-16
, 5-18
Quality Assurance Program (QAP) “Copy To Disk” Feature , 5-21
, 5-23
Contents
xxix
Contents
, 5-24
CHAPTER 6:
Sample Programming and Processing
, 6-1
, 6-2
Sample Programming and Processing
, 6-6
Additional Programming Information , 6-10
CHAPTER 7:
Results Recall
Recall Results by Sample ID , 7-2
Recall Results by Rack and Position
, 7-3
, 7-4
Recall Results by Run Date/Time
, 7-4
Display Recalled Results , 7-5
Edit Critical Rerun Result , 7-6
, 7-7
, 7-8
, 7-10
CHAPTER 8:
User Defined Reagents
, 8-1
Requirements and Precautions , 8-1
, 8-3
, 8-8
, 8-15
Determination of Extinction Coefficients
, 8-16
, 8-17
, 8-19
Expanded User Defined Chemistry Feature
, 8-20 xxx
Contents
CHAPTER 9:
Maintenance
Electronic Maintenance Log , 9-4
, 9-7
Check Chloride Calibration Span , 9-18
, 9-45
As-Needed/As-Required Maintenance
, 9-66
CHAPTER 10:
System Status and Commands
, 10-1
, 10-2
, 10-3
, 10-3
, 10-4
Hydropneumatics Subsystem , 10-4
, 10-6
, 10-7
, 10-8
, 10-8
, 10-9
Enable/Disable Modules , 10-16
, 10-18 xxxi
Contents
CHAPTER 11:
Utilities
, 11-1
, 11-1
, 11-12
, 11-12
, 11-13
, 11-16
CHAPTER 12:
Troubleshooting Calibration and Result Errors
, 12-1
, 12-2
, 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
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
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
BACK TO BACK
CAL FAILED
CHEM DB ERROR
HI REAGENT
LO REAGENT
Remarks on Report
Calibration failed
Calibration failed
Description
Precision error.
Calibration failed.
Chemistry database error.
High reagent level.
Low reagent level.
A13914AF
12-1
Troubleshooting Calibration and Result Errors
MC Calibration
Table 12.1 Calibration Error and Remarks (Continued)
MATH ERR
Printed Flag Remarks on Report
Calibration required
NO SAMP DETECT
OCR HIGH
OCR LOW
RECOVERY
SENSITIVITY
SEV RECOVERY
SEV SENSITVITY
SPAN
RANGE
Calibration failed
Calibration failed
Calibration failed
Calibration failed
Calibration required
Calibration required
Calibration failed
Calibration failed
MC Calibration
Description
Math error – Calibration does not fit expected model.
No sample detected.
Response out of range high.
Response out of range low.
Recovery error
Sensitivity error
Severe recovery error
Severe sensitivity error
Sensitivity error
Accuracy error (ISE)
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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MC Calibration
12
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 Digital-to-Analog Conversion (DAC) Check Limits
Chemistry
NA
K
CL
CO2
CALC
Low
400
-5,900
-2,300
-30,000
-125
DAC Limits
High
5,400
-900
2,700
-20,000
4,875
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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 Maximum Allowable Sample/Reference Deviations by Chemistry
Chemistry Maximum Deviations
NA
K
CL
CALC
Sample
200
150
200
150
Reference
200
150
200
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
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
Sample
Description
The difference between the sample and reference ADC values. This is used for the back-to-back, range, and span checks.
For CO
2
, the sample reference value is the ratio between the sample and reference readings.
The average of eight ADC readings of the calibrator sample.
For CO
2
, the sample ADC represents the rate of pH change initiated by the calibrator sample.
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12
Table 12.4 ISE Module Calibration Report Field Definitions (Continued)
Field Description
Sample Deviation
Reference
Reference 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 CO
2
.
The average of the eight ADC readings corresponding to the measurement of the Electrolyte Reference Solution.
For CO
2
, the reference ADC represents the rate of pH change initiated by the reference reagent.
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.
The concentration value assigned to the calibrator level.
Set Point
Set Point Units
Replicates Used
The units assigned to the set point value.
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
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
Initial Read
Final Read
Represents the rate of change in ADCs during the reaction. Rate is used for back-to-back, span and range checks.
Represents the conductance measured by the electrode or absorbance measured by detector with only reagent present in the cup.
Represents the conductance measured by the electrode or absorbance measured by detector after the reaction has taken place.
The value assigned to the calibrator level.
The units assigned to the set point value.
Set Point
Set Point Units
Replicates Used
Span
The field indicating which two of the four calibrator replicates are used for a particular chemistry.
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.
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Linear Calibration
12
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
.
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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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.
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
Cuv
Set Points
Blank
Reaction
Recovery
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.
The cuvette number on the reaction carousel in which the reaction took place.
The target value for the calibrator.
The blank absorbance when it is an ENDPOINT chemistry or the blank rate
(absorbance per unit time) when it is a RATE chemistry.
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.
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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Linear Calibration
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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
BLANK RATE
BLANK ABS
RXN RATE
RXN ABS
INIT ABS HI
INIT RATE HI
BACK TO BACK
OCR
All others
Magnitude
absolute delta absolute delta absolute delta absolute delta actual value actual value absolute delta absolute delta 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
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.
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Non-Linear and Multipoint Calibrations
12
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.
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
Cuv
Level
Set Points
Blank
Reaction
Description
The following fields identify specific cartridge information.
• 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.
The cuvette number on the reaction carousel in which the reaction took place.
The level of calibrator being run.
The target concentration value for the calibrator level.
The blank absorbance when it is an ENDPOINT chemistry or the blank rate
(absorbance per unit time) when it is a RATE chemistry.
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.
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Non-Linear and Multipoint Calibrations
Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions (Continued)
Recovery
Deviation
Field
Standard Deviation of the Curve
Curve Parameters
Calibration Error Log
Description
The concentration obtained when the final calibrator absorbencies are applied to the calculated curve.
The difference between the obtained absorbance value and the curve in terms of absorbance.
The standard deviation of all the calculated deviation values. An indication of curve fit.
(R
0
, K c
, R, Conc, a, b, c) Positioning and scaling factors for curve determination.
• R
0
– Calculated response for a zero sample
• K c
– Scale parameter
• R – Sample Response
• Conc – Standard
• a, b, c – Parameters which define the non-linear elements of the math model
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.
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Troubleshooting Result Errors
12
Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions (Continued)
Field
Calibration Error Log
Description
Error Flag
BLANK RATE
BLANK ABS
RXN RATE
RXN ABS
INIT ABS HI
INIT RATE HI
SPAN
All others
Magnitude
absolute delta absolute delta absolute delta absolute delta actual value actual value absolute delta 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
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Error Codes and Definitions
Table 12.8 Error Type and Description
Error Type Description
Error appeared in Result Column on report
Error condition appeared in Remarks column on report
Host Code
Instrument Code
Indicates a result issue, result condition, or suppressed result.
Indicates the reason for suppressed results or a condition associated with the result, like reference ranges.
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 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.
below provides descriptions of those codes.
Table 12.9 Result Errors and Codes
Result Displayed on Report Printed in
Remarks Area
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
Host
Code
OK
Inst.
Code
V
O
M
R
P
E
J
D
C
Description
Reagent Days exceeded
Calibration overridden
Calibration time extended
Slope offset adjustment
Set point modification
Reagent Expired
Rerun result
ORDAC result
Default Panel
Calculation completed
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Error Codes and Definitions
12
HI REAGENT
INCOMPLETE
INSUFF DIL1
INSUFF REAG
INVALID CHEM
LEV SENSE ERR
LO REAGENT
MOTION ERR
NO DIL1 ON SYS
NO REAG ON SYS
NO SAMP DETECT
NO SAMP ON SYS
NOT ACCEPTED
PENDING TEST
PROBE OBSTRUCT
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
"Result Printed"
<X (X=lower inst range)
<X (X=lower reportable range)
>Y (Y=upper inst range)
>Y (Y=upper reportable range)
CAL FAILED
CAL TIMED OUT
CHEM ABORTED
CHEM BYPASSED
CHEM NEEDS CAL
CHEM NOT RUN
DAC ERROR
DIL1 LEV SENSE
DIVISION ERROR
Printed in
Remarks Area
CRITICAL HIGH
CRITICAL LOW
HIGH
LOW
TEMP ERR TM
LT
LT
GT
GT
Host
Code
Inst.
Code
ZD
AB
Description
T
Exceeds Critical range high
Exceeds Critical range low
Exceeds reference range high
Exceeds reference range low
Temperature error
Less than X - OIR LO
Less than X - ORR LO
Greater than Y - OIR HI
Greater than Y - ORR HI
Calibration failed
Calibration timed out
Too many retries
Channel bypassed
Chemistry needs calibration
Chemistry not run
ISE DAC Failure
Level sense error in diluent cartridge
Division Error Special calculation divisor is zero
MC reagent level high
Calculation incomplete
Insufficient diluent reagent for scheduled tests
Insufficient reagent strength
Invalid chemistry
Low reagent fluid
MC reagent level low
Motion error
No diluent reagent on the reagent carousel
Reagent not on board
Low sample fluid
Sample not on board
Wrong state for sample program message
Not ready
Probe obstruction detected
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Error Codes and Definitions
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report Printed in
Remarks Area
RACK CONFLICT
RESULT ERROR
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
AG EXCESS
BL ABS HI
BL ABS LO
BL MAX DEV
BL MEAN DEV
BL RATE HI
BL RATE LO
CAL REF DRIFT
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
INIT ABS HI
INIT ABS LO
INIT RATE HI
INIT RATE LO
INIT ADC HI
INIT ADC LO
INIT COND HI
INIT COND LO
K REQ
NA/K REQ
OIR HI
OIR LO
ORDAC HI
ORDAC LO
URDAC HI
URDAC LO
ORR HI
ORR LO
ORR O HI
OVERFLOW
REF NOISE
RX ABS HI
RX ABS LO
AH
AL
IR
IL
BN
SH
SL
EC
AX
BH
BL
BO
UH
UL
UO
OF
OH
OL
GH
GL
DR
HR
LR
IK
IN
DH
DL
HI
LI
CH
CL
Host
Code
Inst.
Code
Description
HDLC/IBCT/HbA1c sample in wrong rack, test cancelled
Result error
Antigen excess
Blank absorbance high
Blank absorbance low
Blank outlier (maximum deviation)
Blank noise (mean deviation)
Blank rate high
Blank rate low
Excessive reference drift – sample to calibration
Initial absorbance too high
Initial absorbance too low
Initial rate too high
CC chemistries, initial rate too low
MC chemistries, a stirrer failure
Initial ADC error high
Initial ADC error low
Initial conductance high
Initial conductance low
Bad K value
Bad NA value
Out of instrument range high
Out of instrument range low
Out of instrument range ORDAC high
Out of instrument range ORDAC low
Under range URDAC high
Under range URDAC low
Out of reportable range high
Out of reportable range low
Out of ORDAC reportable range high
Number overflow error
Reference signal noise (ISE only)
Reaction absorbance high.
Reaction absorbance low
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Error Code – Definitions
12
Table 12.9 Result Errors and Codes (Continued)
Result Displayed on Report
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Results Suppressed
Printed in
Remarks Area
RX ERR
RX MAX DEV
RX MEAN DEV
RX NOISE
RXN RATE HI
RXN RATE LO
SAMP NOISE
SAMP REF DRIFT
Results Suppressed
Results Suppressed
Results Suppressed
TEST STOPPED
TOO MANY TESTS
SUB DEPL
TEMP ERR
MOTOR ERR
Host
Code
RH
RL
DS
ES
RE
RO
RN
EA
Inst.
Code
A
SD
TM
HW
T
Description
Reaction error
Reaction outlier (maximum deviation)
Reaction noise (mean deviation)
Erratic ADC (Cup Chems only)
Reaction rate high
Reaction rate low
Sample signal noise (ISE only)
Excessive reference drift – sample to sample
Substrate depleted
Temperature error (MC only)
Stirrer Motor Error
Test was aborted, system issue
Too many tests on CC
Error Code – Definitions
A13914AF
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.
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Troubleshooting Calibration and Result Errors
Error Code – Definitions
12-18
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
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.
manual for additional information.
A faulty calcium electrode MAY also cause sample reference drift errors on sodium and potassium results.
A13914AF
A13914AF
Troubleshooting Calibration and Result Errors
Error Code – Definitions
12
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.
12-19
Troubleshooting Calibration and Result Errors
Error Code – Definitions
12-20
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
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.
A13914AF
A13914AF
Troubleshooting Calibration and Result Errors
Error Code – Definitions
12
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
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.
12-21
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
Common Error Messages and Corrective Actions
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.
Table 12.10 Error Messages and Corrective Actions
Pop-up ID
Class #
0x01F80019
5
0x01F90005
3
0x01F90084
4
0x01FA0003
4
Event Log Description Corrective Action
Cup positions were out of order. Repeat procedure starting with position 1 which is outermost.
Reagent Carousel
Temperature Error.
Reagent Stability may be compromised.
CAU: Align - Sample rack positions are in reversed order
Message ID: 0x01F80019
CAU: Reagent Carousel
Temperature Error. Reagent
Stability may become compromised
Message ID: 0x01F90005
Subsystem: PWRMGR
Temperature:
Power Smart Module
Communication Error
DI water reservoir is not filling at all
CAU: SMC Receive Error
Message ID: 0x01F90084
Subsystem: PWRMGR
Msg Size: number of bytes
CAU: DI water reservoir is not filling at all
Message ID: 0x01FA0003
Wrong order used for rack positions while performing alignment.
Sensor indicates the air temperature within the reagent carousel is out of range (+2.0°C to +8.0°C).
• Redo the alignment. Make sure the correct positions are used (position 1 is on the outside of the sample carousel).
Intermittent message may be caused by:
• recent loss of power
• system reboot or
• reagent door being open too long
No operator action is necessary.
Consistent messages may indicate issues with the:
• Thermister
• Thermister cable
• Power Control Board
• Peltier Assembly
Contact Beckman Coulter Support Center for additional information.
A communication error has occurred between the Power Distribution Board
(Smart Module 21) and the Instrument
Computer System (ICS).
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.
• 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
the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
• 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.
•
and restart the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA0004
4
0x01FA0006
4
0x01FA0008
4
Description Corrective Action
Flood In Waste
Collection Sump.
Switch #11
CAU: Flood In Waste Sump
Message ID: 0x01FA0004
This error occurs when the waste collection sump float switch indicates that the canister is full, which is considered a flood for this canister.
Flood In Primary
Vacuum Accumulator.
Switch #22
Waste Exit Sump Is Not
Draining At All
CAU: Flood In Primary Vacuum
Accumulator
Message ID: 0x01FA0006
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.
CAU: Waste Exit Sump Is Not
Draining At All
Message ID: 0x01FA0008
This error will flag when the Waste Exit
Sump does not drain within the given drain time for the sump.
• 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.
• 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.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA0009
4
0x01FA000B
4
0x01FA0014
4
0x01FA0015
4
Description Corrective Action
DI Water Canister Is Not
Filling At All
CAU: DI Water Canister Is Not
Filling At All
Message ID: 0x01FA0009
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
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.
—
and restart the system.
— If the error continues, contact Beckman
Coulter Support Center for additional information.
• Load a new bottle of Wash Concentrate. Refer to
Load/Unload Modular Chemistries (MC)
.
Wash Concentrate
Reservoir Is Not Filling
At All
Both The Waste B Exit
Sump And The
Collection Bottle Are
Full. Switch #29,15,9.
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: Wash Concentrate
Reservoir Is Not Filling At All
Message ID: 0x01FA000B
Wash Concentrate Reservoir Is Not Filling
At All.
CAU: Both The Waste B Sump
And The Collection Bottle Are
Full
Message ID: 0x01FA0014
CAU: External Waste B Bottle Is
Full
Message ID: 0x01FA0015
Both The Waste B Sump And The
Collection Bottle Are Full. Only applies to systems configured with the Split Waste
Option.
The Waste B Container is Full. Only applies to systems configured with the
Split Waste Option.
• Empty the external waste B collection bottle and
Resume Waste B.
• Empty the external waste B collection bottle and
Resume Waste B.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA0016
4
0x01FA0019
4
Description Corrective Action
Primary vacuum level is low.
10 psi Air Supply
Pressure Is Low.
CAU: Primary vacuum is low
Message ID: 0x01FA0016
CAU: 10 psi Air Pressure Is Low
Message ID: 0x01FA0019
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
.
• 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.
This error occurs when the transducer line #129 is outputting a value into the
Hydro Board that is below the 10 psi specification.
• Check pressure levels and
• 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.
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA001A
4
10 psi Air Supply
Pressure Is High
Description Corrective Action
CAU: 10 psi Air Pressure Is High
Message ID: 0x01FA001A
This error occurs when the transducer line #129 is outputting a value into the
Hydro Board that is above the 10 psi specification.
• Check pressure levels and
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA001B
4
17 psi air supply pressure is low
0x01FA001C
4
17 psi air supply pressure is high
Description Corrective Action
CAU: 17 psi Air Pressure is Low
Message ID: 0x01FA001B
CAU: 17 psi air pressure is high
Message ID: 0x01FA001C
This error will occur whenever there is a problem within the high-pressure system. If the high pressure reads lower than 14 psi for more than 15 seconds it will be flagged as low.
This error will occur whenever there is a problem within the high-pressure system. If the High pressure reads higher than 19 psi for more than 15 seconds it will be flagged as "High."
•
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.
• If the instrument will not return to Standby, contact Beckman Coulter Support Center for additional information.
• Check pressure levels and
• 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.
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x01FA002B
4
0x01FA0034
4
0x025C0001
4
0x025C0009
4
0x0262000F
4
Hydro Smart Module
Communication
Problem. Stop/Home may resolve this issue.
CAU: Hydro SM not communicating with MSMC.
Check fiber optics communication loop
Message ID: 0x01FA002B
Hydro Illegal Switch
Condition
Instrument Computer
Error
Instrument Computer
Error
CC Sample Probe
Disabled Due To Level
Sense Errors
CAU: Hydro Illegal Switch
Condition
Message ID: 0x01FA0034
Container: container
CAU: Debug port abort
Message ID: 0x025C0001
Subsystem: CAU
Problem Area: problem area
CAU: Bus Error
Message ID: 0x025C0009
Subsystem: CAU
Task Name: task name
Vector ID: vector id
CAU: CC Sample Probe
Disabled Due To Level Sense
Errors
Message ID: 0x0262000F
Subsystem: RASched
Description
System stopped. Communication issue with hydro smart module.
Float Switch sending full and empty messages at the same time.
Likely cause is the Instrument computer has attempted to access a restricted area or file.
Corrective Action
• 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
the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
• Unscrew the canister. Wipe the float switch and make sure the float is not stuck.
• Replace the Float Switch in the specified container.
• At the Red Message screen, select
• 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
• If the problem continues contact Beckman
Coulter Support Center for additional information.
Five consecutive sample level sense errors – probe, bead, bad alignment or level sense board problem.
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
procedure.
• Perform CC Sample Probe Level Sense
Alignment (Calibration).
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620012
4
0x02620017
2
Description Corrective Action
CC Reagent Cartridge –
No Fluid Detected
Chemistry Name:
chemistry name
Reagent Position:
reagent position
Component:
component
CC Reaction Wheel
Subsystem Motion Error
CAU: CC Reagent Cartridge No
Fluid Detected
Message ID: 0x02620012
Subsystem: RASched
Chemistry Name:
Reagent Position:
Component:
Two consecutive reagent level sense errors for same cartridge – cartridge is unusable.
This error will occur with any type of motion error within the Reaction Wheel.
CAU: CC Reaction Wheel
Subsystem Motion Error
Message ID: 0x02620017
Subsystem: RASched
Action Name: action name
• Remove bubbles from cartridge neck or floating on reagent surface.
• Reload reagent cartridge.
Refer to Load/Unload Cartridge Chemistries
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620018
2
CC Reagent Delivery
Subsystem Motion
Error, Pausing
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.
The CC side of the system is placed into
Pausing then Stopped state.
• 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
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).
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
0x0262001A
4
CC Sample Probe
Obstruction
Sample ID:
Rack ID:
Rack Position:
This occurs on first attempt
CAU: CC Sample Probe
Obstruction
Message ID: 0x0262001A
Subsystem: RASched
Sample ID:
Rack ID:
Rack Position:
Sample Error Count:
Probe Error Count:
Cycle Number:
Description 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.
This error occurs when the CC sample probe ODC (Obstruction Detection &
Correction) indicates that the probe is obstructed during sample aspiration.
• 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
procedure.
• If the Syringe is responsible, check for proper seating of syringe assembly.
• Contact Beckman Coulter Support Center for additional information.
• No operator action is necessary.
• The system will attempt a second aspiration from this sample.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x0262001B
4
0x0262001D
2
Unrecovered CC
Sample Probe
Obstruction
CC Reagent Probe A
Motion Error
CAU: Unrecovered CC Sample
Probe Obstruction
Message ID: 0x0262001B
Subsystem: ccScheduler
CAU: CC Reagent Probe A
Motion Error
Message ID: 0x0262001D
Subsystem: RASched
Action Name: action name
Description Corrective Action
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,
• 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
• 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
procedure.
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x0262001E
2
CC Reagent Probe B
Motion Error
CAU: CC Reagent Probe B
Motion Error
Message ID: 0x0262001E
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:
Description Corrective Action
This error is caused by a Vertical or
Rotary motion error. This will cause the instrument to go into a Stopped state.
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 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
• 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
.
• Contact Beckman Coulter Support Center for additional information.
• 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.
the system.
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620022
2
CC Reagent Wheel
Motion Error
0x02620024
2
CC Sample Mixer
Motion Error
Description Corrective Action
CAU: CC Reagent Wheel
Motion Error
Message ID: 0x02620022
Subsystem: RASched
Action Name: action name
CAU: CC Sample Mixer Motion
Error
Message ID: 0x02620024
Subsystem: RASched
Action:
The CC Reagent wheel observed a motion error. The wheel itself may be obstructed.
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.
• Shutdown the instrument. Refer to
.
• 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
.
• If the problem continues, contact Beckman
Coulter Support Center for additional information.
• 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.
•
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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620025
2
0x02620033
4
0x02620034
4
Description Corrective Action
CC Sample Syringe
Motion Error
CC Reagent probe disabled due to level sense errors
CAU: CC Sample Syringe
Motion Error
Message ID: 0x02620025
Subsystem: RASched
Action Name: action name
10 Cuvettes Have failed
Water Blank
CAU: 10 Cuvettes Have Failed
Water Blank
Message ID: 0x02620033
Subsystem: RaSched
CAU: CC Reagent Probe
Disabled Due To level Sense
Errors
Message ID: 0x02620034
Subsystem: RASched
Probe: probe
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:
• 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.
Multiple reagent cartridges have level sense errors.
• Remove wash station head and inspect probes for blockage and wiper for wear. Refer to
for removal of Wash
Station.
• Check wash station wiper alignment.
• Check wash station alignment.
• Remove reaction carousel and check cuvette cleanliness.
Non-resolution of problem may indicate photometer issues. Contact Beckman Coulter Support Center for additional information.
•
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
procedure.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620036
4
0x0262003A
4
0x0262003F
4
Description Corrective Action
Level sense error in one or more cartridges
CC Sample Probe disabled due to obstruction errors
Too many tubes not venting correctly, sampling for the CC probe will be stopped
CAU: Level sense error in one or more cartridges
Message ID: 0x02620036
Subsystem: RASched
CAU: CC Sample Probe
Disabled Due To Obstruction
Errors
Message ID: 0x0262003A
Subsystem: ccScheduler
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.
Multiple samples had Obstructions
(Clots).
• 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
• 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.
• 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
Sample and Reagent Probe procedure.
• Replace probe. Refer to Step 3 of the Replace the Sample and Reagent Probe procedure.
CAU: CC Sample Probe disabled due to Excess Vacuum
Errors
Message ID: 0x0262003F
Subsystem: ccScheduler
Multiple tubes had excessive vacuum 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
or Replace CTS Blade (1-Blade Narrow
CTS Option) to inspect the blade.
• Perform CC ODC Alignment.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02620040
4
0x0262004B
4
0x02660001
4
0x02680001
4
Description Corrective Action
Too many tubes not venting correctly, sampling for the CC probe will be stopped
CC Sample Side
Pausing Due to Sample
Rack Subsystem
Stopped
CAU: CC Sample Probe
Disabled due to Excess
Pressure Errors
Message ID: 0x02620040
Subsystem: ccScheduler
CAU: CC Sample Side Pausing due to Sample Rack
Subsystem Stopped
Message ID: 0x0262004B
Subsystem: ccSched
No Diluent Cartridge
CC Sample Level Sense
Error
Sample ID: sample id
Rack ID: rack id
Rack Position: rack
position
CAU: No Diluent Cartridge
Message ID: 0x02660001
Subsystem: RASched
Chem Name: chem id
CAU: CC Sample Level Sense
Error
Message ID: 0x02680001
Subsystem: ccScheduler
Sample ID: sample id
Rack ID: rack id
Position: rack position
Multiple tubes had excessive pressure in thick stopper closed tubes. CC Sample
Probe Disabled.
Likely cause is an obstruction in the sample rack handler. Current In-Process samples will continue until finished. No more samples will be loaded.
Diluent cartridge must be loaded to performed requested tests. Tests requiring the diluent cartridge will be incomplete.
• 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
the system.
• Check for any obstructions in the sample rack handler and clear any obstruction found.
•
the system.
• Reload any incomplete racks.
• Press the RUN button to resume testing.
• Load a DIL1 Cartridge. Refer to Load/Unload
.
This error occurs under following conditions:
• 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 cap piercer for broken blade. Refer to
Replace CTS Blade/Wick (1-Blade Thick CTS
or Replace CTS Blade (1-Blade Narrow
CTS Option) to inspect the blade.
• Perform CC ODC Alignment.
• Check sample for adequate volume
• Check proper rack assignment for type of container used (reserved vs. non-reserved).
Refer to Assigning or Reassigning Reserved
• Check for fluid in collar wash – fluid in collar wash can trigger false level sense.
• Check alignment of sample probe in collar wash.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02680002
4
0x02680003
4
0x02680004
4
Description Corrective Action
CC Sample Obstruction
Error
Sample ID:
Rack ID:
Rack Position:
CAU: CC Sample Obstruction
Message ID: 0x02680002
Subsystem: RASched
Sample ID:
Rack ID:
Position:
Sample tube did not vent correctly. Remove cap and reload tube.
Sample ID: sample id
Rack: rack id
Position: rack position
CC Sample Probe
Sample tube did not vent correctly. Remove cap and reload tube.
Sample ID: sample id
Rack: rack id
Position: rack position
CC Sample Probe
CAU: CC Sample Tube Excess
Vacuum Error
Message ID: 0x02680003
Subsystem: RASched
Sample ID: sample id
Rack ID: rack id
Rack Position: rack position
CAU: CC Sample Tube Excess
Pressure Error
Message ID: 0x02680004
Subsystem: RASched
Sample ID: sample id
Rack ID: rack id
Rack Position: rack position
This error occurs when an obstruction is detected on a second aspirate attempt of the same sample.
Probe detected excessive vacuum in thick stopper closed tube on second attempt. Sample is aborted.
• 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
• 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.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x02BC1300
4
0x02BC2107
4
0x032B0005
2
Description Corrective Action
Photometer Error (error
message), Command:
0xcommand, Error
Number: 0xerror
number
CAU: Photometer Error
Message ID: 0x02BC1300
Error Msg: error message
Command: 0xcommand
Error number: 0xerror number
This error occurs when the photometer fails to successfully read/analyze a cuvette. There are several types of
Photometer Smart Module (PSM) errors.
If for any reason the instrument "Stops" 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.
• Press the STOP button and Home
the system.
• Check Event Log for specific PSM subsystem
• Contact Beckman Coulter Support Center for additional information.
Failed to Initialize
Photometer
CC Obstruction
Detection Transducer
Failure
CAU: Failed to Initialize PSM
Message ID: 0x02BC2107
The Photometer Smart Module (PSM) failed to initialize during startup or homing, the CC side is stopped.
CAU: CC Obstruction Detection
Transducer Failure
Message ID: 0x032B0005
Subsystem: rasdSmc
This error usually occurs whenever the obstruction transducer does not see fluid during runtime. Often this comes from a clogged degasser or lack of Degassed 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.
• 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
the system.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x03350010
2
0x03880006
3
0x03EA0009
4
MC Obstruction
Detection Transducer
Failure
CC Reaction Carousel
Temperature Out of
Range
Instrument Detected
Power Loss
CAU: MC Obstruction Detection
Transducer Failure
Message ID: 0x03350010
Subsystem: ppsdSmc
CAU: cc rwHtr reaction wheel temp out of range
Message ID: 0x03880006
Subsystem: cc rwHtr
CAU: Instrument Detected
Power Loss
Message ID: 0x03EA0009 conditions:
Description
MC Obstruction detection hardware failure.
This error occurs under the following
• 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.
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
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x04B2001C
4
0x04B2001E
4
0x04B2001F
4
Description Corrective Action
MC Sample Level Sense
Error
Sample ID: sample id
Rack: rack id
Position: rack position
CAU: Sample Level Sense Error
Message ID: 0x04B2001C
Sample ID: sample id
Rack: rack id
This error occurs under following conditions:
• 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
• Check for fluid in collar wash – fluid in collar wash can trigger false level sense.
• Check alignment of sample probe in collar wash.
MC Sample Probe
Obstruction
Sample ID: sample id
Rack ID: rack
Position: position
This occurs on first attempt
Unrecovered MC
Sample Probe
Obstruction
CAU: MC Sample Probe
Obstruction
Message ID: 0x04B2001E
Sample ID: sample id
Rack: rack
Position: position
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.
CAU: Unrecovered MC Sample
Probe Obstruction
Message ID: 0x04B2001F
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
.
• If probe is clear and error continues, check for pinched Sample line tubing.
• If the error continues contact Beckman
Customer Support.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x04B20026
4
0x04B20027
4
0x04B3000F
4
0x04B30010
4
Description Corrective Action
Sample tube did not vent correctly. Remove cap and reload tube.
Sample ID: sample id
Rack: sample rack id
Position: sample
position, MC Sample
Probe
Sample tube did not vent correctly. Remove cap and reload tube.
Sample ID: sample id
Rack: sample rack id
Position: sample
position, MC Sample
Probe
ISE DAC Setting Failed
Chem Name: chem id
CAU: MC Sample Tube Excess
Vacuum
Message ID: 0x04B20026
Sample ID: sample id
Rack ID: sample rack id
Pos: sample position
CAU: MC Sample Tube Excess
Pressure
Message ID: 0x04B20027
Sample ID: sample id
Rack ID: sample rack id
Pos: position
CAU: ISE DAC Setting Failed
Message ID: 0x04B3000F
Chem Name: chem id
Probe detected excessive vacuum in thick stopper closed tube on second attempt. Sample is aborted.
Probe detected excessive pressure in thick stopper closed tube on second attempt. Sample is aborted.
ISE DAC Setting Failed for the specified chemistry.
MC Reagent Level High in Reaction Cup
Chem Name: chem id
CAU: Reagent too full
Message ID: 0x04B30010
Cup: chem id
MC sample probe detected reagent in the cup module above the expected level.
• 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.
• 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.
• 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.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x04B30011
4
0x04B30013
4
0x05780015
4
MC Reagent Level Low
MC Sample Probe disabled due to obstruction errors
No Foam Is Empty
Chem Name:
CAU: Reagent too low
Message ID: 0x04B30011
Subsystem:
Chem Name:
CAU: MC Sample Probe disabled due to obstruction errors
Message ID: 0x04B30013
CAU: No Foam is Empty
Message ID: 0x05780015
Subsystem: SRMGR
Description 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.
More than 3 samples in a row had obstruction errors (clots), MC side
Stopped.
No Foam has 0% left.
• 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.
• Prime MC internal probe wash to make sure it is not obstructed. Refer to
(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).
The system continues to process all samples onboard the sample carousel, then goes to Stopped state.
• Make sure the system is in Stopped state.
• Home the system.
• Load No Foam Reagent. Refer to
.
• If there are sample racks on the DxC sample wheel, request the system to unload racks.
.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x057A0008
4
Rack Out of Range CAU: Invalid Rack ID
Message ID: 0x057A0008
Subsystem: SRShttl
0x057A0009
4
Duplicate Rack ID rack
#
CAU: Duplicate Rack ID
Message ID: 0x057A0009
Subsystem: SRShttl
Rack ID: rack #
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.
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.
• 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
.
• 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
— 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.
• 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
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x057A000A
4
0x057A000E
4
0x057B0008
4
0x05DC0070
4
Description Corrective Action
Tube Too Tall for Cap
Piercing Sample Wheel.
Rack; Cup:
Rack Height Not
Defined
Offload Track Is Full
Instrument Computer
Interprocess Error
CAU: Incompatible Tube Type
Message ID: 0x057A000A
Subsystem: SRShuttle
CAU: Rack Height Not Defined
Message ID: 0x057A000E
Subsystem: SRShttl
CAU: Offload Track Is Full
Message ID: 0x057B0008
Subsystem: SRLdr
CAU: Boot Task - Message
Receive Error
Message ID: 0x05DC0070
Subsystem: boot
Err no: errno
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.
CTS is installed and the sample rack does not have a height defined.
• Make sure tubes are approved for use and in
appropriate rack for tube size. Refer to Sample
.
• Make sure rack is designated properly as a 100 or 75 mm rack in the Reserved Rack screen.
Refer to Assigning or Reassigning Reserved
• 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.
• Make sure the rack height is defined. Refer to
Figure 2.2, Reserved Racks/Obstruction
.
This error will occur when the offload trays sensor has been triggered. This error is working as designed in most cases.
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.
• 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.
• At the Red Message screen, select
• If the problem continues after the instrument has been shutdown, contact Beckman Coulter
Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x05DC0096
4
0x05DC01F8
4
Description Corrective Action
Smart Module
Download Failed. Smart
Module ID: sm id
CC Reagent Mixer
Motion Error
CAU: Boot Task - SM Download
Failed
Message ID: 0x05DC0096
Subsystem: boot
SM ID: sm id
CAU: Homing Error for CC
Reagent Mixer
Message ID: 0x05DC01F8
Subsystem: boot, homing
command
Smart module communication error
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:
• "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.
• 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
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.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x05DC01FB
4
CC Reagent Carousel
Motion Error
CAU: Homing Error for CC
Reagent Carousel
Message ID: 0x05DC01FB
Subsystem: boot, homing
command
0x05DC01FD
2
0x05DC01FF
4
CC Sample Mixer Error
Sample Autoloader
Error
CAU: Homing Error: $s
Message ID: 0x05DC01FD
CAU: Homing Error: $s
Message ID: 0x05DC01FF
Description Corrective Action
This error occurs when there is any homing issue with the Reagent Carousel
Subsystem. This includes the following:
• Upper/Lower reagent decks/motors.
• Both decks flag sensors.
• The magnetic door sensor.
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.
• 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.
• 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.
•
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.)
the system.
• If error continues after
check event log for specific sub-system homing error. Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x05DC0200
4
0x05DC0201
4
CC Subsystem Error
CC Reaction Carousel
Subsystem Error
CAU: Homing Error for CC
Subsystem
Message ID: 0x05DC0200
Subsystem: boot, homing
command
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.
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.
• 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.
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
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
the system.
• If the error continues after homing, contact
Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x05DC0202
2
MC Cups/ISE
Subsystem Error
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.
• 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.
System Stopped. Generic homing error message. Check Event Log for specific subsystem errors.
• Press the STOP button and Home
the system.
• Reboot system. Refer to Shutdown .
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x05DC0204
4
0x05DC0227
4
0x1391000E
MC Probe/Syringe Error
No Response From
Hydro Subsystem
CAU: Homing Error for MC
Probe/Syringe
Message ID: 0x05DC0204
Subsystem: boot, homing command
CAU: Homing Timeout for
Hydro Subsystem
Message ID: 0x05DC0227
Subsystem: boot, homing
command
Instrument stopped communicating with console
ROUTER: Cable down detected. (/mpcvan/src/ cauman/cau_router.c:1675)
Message ID: 0x1391000E
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.
This error occurs when the hydro fails to respond to commands or fails to attach.
This event can be generated by any
Hydro command sent by start.dat including "AttachHydro",
"StartAutomonitor", "HydroInitStatus", or "HydroWatchdogOn".
• 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
the system.
• While the system Homes, check for possible interference issues. If the error continues after homing,
• If the problem continues after the instrument has been shutdown and rebooted, contact
Beckman Coulter Support Center for additional information.
• Check Event Log for specific subsystem errors.
• Press the STOP button and Home
the system.
.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
This Fatal Error will occur when a network connection has been lost and the computer console cannot communicate with the instrument.
• Make sure Instrument is on. Refer to
.
• Check Ethernet cable connection at console, microhub and instrument.
• Reboot system. Refer to Shutdown .
• Contact Beckman Coulter Support Center for additional information.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13940013
7
0x13940014
7
0x13940015
7
0x1394001B
7
0x1399002D
7
0x1399002E
7
Description Corrective Action
PVT:
ERROR: Insufficient reagent
PVT:
ERROR: Insufficient sample
PVT:
ERROR: Motion
PVT:
ERROR: Insufficient reagent
File: filename
Line: lineno
PVT:
ERROR: Insufficient sample
File: filename
Line: lineno
PVT:
ERROR: Motion
File: filename
Line: lineno
MAINT: Cannot block the run button
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.
PVT: cannot block the run button
File: filename
Line: lineno
PRTMGR: Task: task - error.
(filename, linenumber)
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.
Cannot perform the test because there is not enough reagent.
Sample Level Sense error while running
PVT.
• Load a new PVT reagent cartridge. Refer to
Load/Unload Cartridge Chemistries (CC)
• 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.
•
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.
Logs that the printing is down in the event log and displays the note to inform the user.
• Reboot the DxC system. Refer to
• Review and reprint the missing reports.
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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x139C000C
7
Unable to initialize keyboard navigation.
Unable to initialize keyboard navigation for <Subsystem>.
Description
There was a problem initializing the keyboard navigation.
Corrective Action
• Contact Beckman Coulter Support Center for additional information.
0x139D0044
7
0x139F0036
9
0x139F0037
9
0x139F0038
9
Data May Be Out Of
Order Due to Date/Time
Change
SS: date/time was set backwards from previous value to new value
Information to user that changing system date or time (specifically backwards) will cause certain data to be out of order.
• No operator action is necessary. Be aware events will be out of order.
One or more chemistries will timeout soon
STM: One or more chemistries will timeout soon
At least one chemistry will require recalibration within 1 hour.
The within lot calibration factor for the specified chemistry will timeout soon.
• Check Reagent Load/Calibration screen for calibration information. Refer to
• Begin to prepare to calibrate required
chemistries. Refer to Request a Calibration .
• No operator action is necessary. The next time a fresh cartridge of the specified chemistry is loaded, it will require calibration.
Within Lot Cal Factor
Timeout in hours
Hours:
Chemistry: chem
Lot No: lot no
Serial No: serial no
Pos: position
Within Lot Cal Factor
Timeout in hours
Hours:
Chemistry: chem
Lot No: lot no
Serial No: serial no
STM: Within Lot Cal Factor
Timeout in hours
Hours:
(Chemistry: chem
Lot No: lot no
Serial No: serial no
Pos: position)
STM: Within Lot Cal Factor
Timeout in hours
Hours:
(Chemistry: chem
Lot No: lot no
Serial No: serial no)
The within lot calibration factor for the specified chemistry will timeout soon.
• No operator action is necessary. The next time a fresh cartridge of the specified chemistry is loaded, it will require calibration.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x139F0039
9
0x139F003A
9
0x139F0068
7
Description Corrective Action
Reagent Cartridge has less than 5 tests left:
Reagent: reagent
Position: position
Lot #: lot num
Serial #: serial num
MC Reagent container has low volume:
Reag: chem
Volume: volume
Lot no: lot no
Serial No: serial no
CTS Tracking
Information can NOT be shared between all instruments. When you move a tube to a different instrument, remove its cap. You will be notified when full
CTS tracking is restored.
STM: Reagent container has less than 5 tests left:
Reag: chem
Lot No: lot no
Serial No: serial no
Pos: position
STM: Reagent container has low volume remaining:
( Reag: chem
Volume: volume
Lot no: lot no
Serial No: serial no)
STM: TS-CTS Tracking System disconnect detected
Message ID: 0x139F0068
Specified reagent cartridge has less than
5 tests remaining.
MC reagent container is getting low.
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.
IMPORTANT
TS-CTS stands for Thick-
Stopper, Closed Tube Sampling.
• Prepare to load another cartridge if another is
not already on-board. Refer to Load/Unload
.
• Begin preparations to load another container.
Refer to Load/Unload Modular Chemistries (MC)
• 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
.
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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x139F0069
9
0x13A00004
10
0x13A0001C
10
0x13A00022
10
0x13A00023
10
Description Corrective Action
Full CTS Tracking is now available.
When you move a tube to a different instrument, it is not necessary to remove its cap.
Requested Rack Not
Loaded
Rack: rack ID
STM: TS-CTS Tracking System reconnect detected
WLM: Rack rack ID cannot be loaded
(FileName:LineNumber)
All of the systems that we expect to be networked together are connected (it has recovered from a disconnect state).
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.
• No operator action is necessary. Databases automatically synchronize and caps can be left in place.
• Correct the accompanying motion error and reload the rack.
Non-programmed samples on rack.
The QC Database is
xx% full. Archiving is suggested.
WLM: Unprogrammed samps,
Rack: rack ID
[p:PositionSample ID]
[p:PositionSample ID]
[p:PositionSample ID]
[p:PositionSample ID]
WLM: QC DB is xx% percent full
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.
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 has been overwritten.
WLM: QC DB is full. The oldest result for
control: control name /
Chem: chem name has been 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A00024
10
0x13A0003F
10
0x13A00056
10
0x13A00057
10
Description Corrective Action
QC Database is full. This result was not saved.
WLM: QC DB is full. The result for
control: control name /
Chem: chem name has not been saved
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.
Incomplete set of calibrator levels in rack
rack ID for the following calibrators: calibrator
name list
WLM: Missing calibrator levels
Rack: rack ID
Calibrators: calibrator list (File
Name:Line Number)
Not all calibrator levels were loaded or were loaded out of order.
No sample programming or pending test found for samples in rack #<rack
ID>. Rack will be unloaded from <rack location>
Required levels for calibrator not loaded.
Rack will be unloaded from the sample carousel.
Rack: rack ID
Calibrator: calibrator
name
WLM: No sample programming or pending tests found for sample on rack.
Rack ID: <rack ID> (<File
Name>:<Line Number>)
A rack was loaded with nothing to run.
The rack is off-loaded and any previous results are printed.
WLM: Subsequent calibrator levels not loaded for multi-rack calibrator on rack rack ID (File
Name:Line Number)
Not all calibrator levels were loaded or were loaded out of order.
•
• Reload calibrator racks.
• Make sure bar codes are readable. Refer to Bar
• 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.
• 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
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A00059
10
0x13A0007E
10
0x13A00092
10
Description Corrective Action
Scanned barcodes in rack #<rack ID> contain invalid characters. Rack will be unloaded from <rack location>
WLM: Barcodes contain invalid chars.
Rack: <rack ID>
[1:<sample ID>]
[2:<sample ID>]
[3:<sample ID>]
[4:<sample ID>]
Sample bar code contains illegal characters.
Module: xxxxxx is disabled due to a system error. All module functioning has now ceased. When the problem is fixed, enable the module through
Instrument Commands.
WLM: Received request to disable module: Module (File
Name:Line Number)
Specified module has been disabled automatically. This will normally have severity of IM.
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]
• Check the sample bar code for illegal
Commands,
vacuum problem.
• Make sure the complete bar code is visible and there are no smudges or wrinkles. Refer to
• Enable the module under Instrument
Enable/Disable Modules . If the
problem continues, it could be a valve or
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
.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A000CE
10
0x13A000E4
10
Description Corrective Action
Samples in rack #
<rack number> have barcodes longer than
15 characters. Rack will be unloaded from
<rack location>
Position Sample ID
1 ID too long
2 ID too long
3 ID too long
4 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.
WLM: Rack contains samples with barcodes > 15 characters.
Rack: <rack #>
[1:<cup1 ID>]
[2:<cup2 ID>]
[3:<cup3 ID>]
[4:<cup4 ID>]
WLM: Stirrer motor error - module disabled: <module name> (<file>:<line>)
One or more samples were loaded with barcodes longer than 15 characters.
If a motor speed error occurs, the following symptoms are exhibited:
• 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.
• Check barcodes on samples in rack.
• Reload rack.
• If the error continues, contact Beckman Coulter
Support Center for additional information.
• 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.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A10012
7
0x13A20008
7
0x13A20015
7
0x13A20016
7
0x13A20019
7
0x13A50024
6
Description Corrective Action
MAINT: All or some of the report name did not print.
MAINT: Cannot block the run button.
MAINT: All or some of the
report name did not print
File: filename
Line: lineno
MAINT: Cannot block the run button
File: filename
Line: lineno
MAINT:
ERROR: Motion.
MAINT:
ERROR: Reagent has not been loaded.
MAINT:
ERROR: Requested rack not loaded.
Host Communication
Error, Check Event Log
All or some of the report did not print.
Unable to transition to Maintenance.
Samples may still be running.
MAINT:
ERROR: Motion
File: filename
Line: lineno
MAINT:
ERROR: Reagent has not been loaded
File: filename
Line: lineno
MAINT:
ERROR: Requested rack not loaded
File: filename
Line: lineno
HC: Host Port Communication
Error
Motion error observed while performing requested maintenance. Test aborted, no results are available.
Maintenance procedure aborted because the reagent has not been loaded.
Maintenance procedure aborted because the requested rack was not loaded.
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.
• Reprint the report.
• Wait for samples to complete and system to go to Standby before requesting Maintenance procedure.
•
and restart the maintenance.
• Load the reagent and retry the request. Refer to
.
• The wrong rack was loaded. Check the rack ID and retry.
• Make sure the bar code faces to the right when loading.
• Check the LIS for status.
• Check cable connections.
• Make sure the host setup parameters have not
been changed. Refer to Host Communications ,
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A50026
6
0x13A50097
6
0x13A70004
7
0x13A70005
7
0x13A70006
7
Description Corrective Action
Host Communication
Line Down, Check
Event Log
Host Communication
Line Down, Check
Event Log. No new messages will be sent.
Review Host Comm
Setup to re-enable.
Instrument not in proper state.
Instrument not in proper state.
or
Unable to send Home message.
Instrument not in proper state.
HC: Host line down
HC: Chronic Host Port
Communications Error
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.
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.
• Check cable connections.
• Check the host setup parameters have not been changed. Refer to
.
• Check the LIS for status.
• Go to
. Exiting screen will force the system to reestablish communication.
• Check cable connections.
• Make sure the host setup parameters have not been changed.Refer to
,
• Wait for the system to get to Standby/Stopped/
Disabled/PVT/Diag/Maint or Align.
• Reboot if necessary. Refer to
ICMD: System Error. Cannot
HOME
CAU: restart may be required
File: filename
Line: line number
System is not in proper state for Homing
(usually still Stopping). Must be Standby/
Stopped/Disabled/PVT/Diag/Maint or
Align
ICMD: Cannot HOME in current state.
File: filename
Line: line number
The instrument is not in the proper state for Homing (usually still Stopping). All sides of the instrument must be in
Standby, Stopped, Disabled, PVT, Diag,
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.
.
ICMD: Cannot PAUSE in current state
File: filename
Line: line number
The instrument is not in the proper state to accept a PAUSE command. Only select PAUSE when not already in a
Pausing state and at least one side of the instrument is running.
• If Pause was previously selected, the System will go to Standby automatically.
Pause only when at least one side of the
system is running.
• Reboot if necessary. Refer to
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13A70007
7
0x13AC0008
7
0x13AC000B
7
0x13A70010
7
0x13A70012
7
0x13A70013
7
Instrument not in proper state.
ICMD: Cannot SHUTDOWN in current instrument state.
File: filename
Line: line number
Description
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.
Corrective Action
• 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
system.
• To immediately shutdown, press the STOP button and wait to go to the Stopped state, then request Shutdown.
Cannot create socket.
Unable to connect to instrument
Instrument not in proper state.
Unable to send message to DxC
Instrument.
Unable to send message to DxC
Instrument.
BOOT: Cannot create socket Unable to create a network socket
(shutdown didn't complete cleanly).
BOOT: Select failed
ICMD: Cannot disable Lower
Reagent Carousel in current instrument state.
File: filename
Line: line number
ICMD: Cannot <Action> Waste
B operation, possible line down sending msg. #916
CC was not in Standby/Stopped state when the Lower Reagent Carousel was disabled.
Unable to send request to DxC instrument. Check to see if the cable is correctly attached.
ICMD: Cannot Enable/Disable
CAU modules
(<EnDisStatus>), possible line down sending msg. #932
Unable to boot.
Unable to send status update to DxC instrument. Check to see if the cable is correctly attached.
• Make sure the instrument power is on and reboot. Refer to
. Continued errors may indicate an incorrect hardware address.
• Wait until the instrument goes to a Standby or
Stopped state before attempting to disable the lower reagent wheel.
• Check the connections between the DxC
Instrument and the Console Computer.
• If the problem continues, reboot the DxC
• Check the connections between the DxC
Instrument and the Console Computer.
• If the problem continues, reboot the DxC
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13AC0016
5
0x13AC0040
7
0x13AC0051
4
0x13AD000B
7
0x13AD0013
7
0x13AD001E
7
0x13AD0020
7
Description Corrective Action
Automatic smart module download:
smart modules.
STOP button pressed.
Press HOME to home instrument.
BOOT: Automatic smart module download: smart
modules
BOOT: STOP button pressed
Message ID: 0x13AC0040
After new software is loaded, new software was downloaded to the indicated smart module.
This popup is expected when the
Operator presses the STOP button.
• No operator action is necessary.
•
the system.
Instrument Computer
Error
Boot: Instrument attempted a second ICC (Instrument Control
Computer) boot
Likely cause is an Internal
Communication issue. Possible bad
Ethernet connection causes Instrument to attempt a second boot.
Database Version number on disk doesn't match Database
Version number.
Backup/Restore: Database
Version number on disk doesn't match Database Version num
File: file
Line: line
Error copying to floppy
Backup/Restore: Error copying to floppy
File: file name
Line: line num
The contents of the backup are from a different version of the Console Software and cannot be restored on this version.
System cannot identify inserted disk.
Backup and Restore procedure will abort.
• Use a newer disk if available.
• Make sure the diskette is inserted correctly.
• Try another diskette.
Error formatting floppy Backup/Restore: Error formatting floppy (fdformat)
No Contents file on floppy
File: file name
Line: line num
Backup/Restore: No TOC floppy file
File: file name
Line: line num
Cannot format floppy.
System cannot identify inserted disk.
Probably a blank disk or incorrect format.
• At the Red Message screen, select
• If the problem continues after the instrument has been shutdown, contact Beckman Coulter
Support Center for additional information.
• Make sure the diskette is inserted correctly.
• Try another diskette.
• Use another disk if available.
Table 12.10 Error Messages and Corrective Actions (Continued)
Pop-up Event Log ID
Class #
0x13AD0029
7
0x13AD002A
7
0x13AD002B
7
0x13AD0040
7
0x13AD0041
7
Description Corrective Action
Backup Type on disk doesn't match request type
Instrument serial number on disk doesn't match Instrument serial number
Backup/Restore: Backup type on disk doesn't match request type
Incorrect disk format, probably a different backup.
File: file name
Line: line num
Backup/Restore: Inst serial number on disk doesn't match
Inst serial num
File: file name
Line: line num
Trying to restore from a disk for a different system.
• Use another disk if available.
• Use another disk if available.
S/W Version on disk doesn't match MPC S/W
Version
Bad Floppy, replace floppy and try Backup again
Backup/Restore: SW Version on disk doesn't match MPC SW
Version
File: file name
Line: line num
Backup/Restore: Bad floppy, cannot read from floppy during backup
File: file name
Line: line num
The contents of the backup are from a different version of the Console Software and cannot be restored on this version.
Cannot check backup.
• Use another disk if available.
• Repeat Backup with different disk.
Chemistry Version number on disk doesn't match Chemistry
Version number
Backup/Restore: Chemistry
Version number on disk doesn't match Chemistry Version num
File: file
Line: line
The contents of the backup are from a different version and cannot be restored on this version.
• Use another disk if available.
Glossary
A13914AF
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
(
O
ut of
I
nstrument
R
ange).
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.
Glossary-1
Glossary
Glossary-2
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.
A13914AF
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.
Glossary-3
Glossary
Glossary-4
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.
A13914AF
Glossary
A13914AF
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.
Glossary-5
Glossary
Glossary-6
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.
A13914AF
Glossary
A13914AF
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 (
O
ut of
R
eportable
R
ange).
Glossary-7
Glossary
Glossary-8
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.
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
1-Blade CTS option
1-Blade Narrow CTS,
70% isopropyl alcohol,
A
AccuSense glucose sensor
Drain reaction cup for sensor, 9-59 ,
Prepare prior to replacement, 9-60
Replace, six-month,
,
Air filters
Alarm/Annunciator
Alignment
See UniCel DxC Synchron Clinical Systems
Reference Manual
Alkaline buffer damper assembly
Adjust fluid level,
Fluid level high,
Fluid level low,
Replace alkaline buffer reagent, 9-18
Archive QC Data,
Auto ORDAC,
Auto serum index,
Autoloader,
B
Backup,
Alignment data,
Hand-held (MC),
Sample,
Boot
Full boot,
Buttons,
C
Calibration
Acceptance limits,
Bypass,
Calibrator set point modifications, 4-28
Enzyme validator,
Extending calibration time, 4-26
Failure messages,
Formulas
Endpoint and first-order, 1-44 –
Reprint calibration report,
Request
Canceling a calibration request, 4-18
Status,
Within-lot calibration,
Enabling within-lot calibration, 4-19
Index-1
Index
Index-2
Frequency,
Cap piercer
1-Blade Narrow CTS,
1-Blade Narrow CTS option, 9-32
1-Blade Thick CTS option,
Carousel,
Cartridge chemistries (CC),
Spectrophotometric methods,
CC — Cartridge chemistry,
CC reagent mixer, clean,
CC sample mixer, clean,
CC sample probe, reagent probes and mixers
Automated cartridge chemistry probe cleaning
CCWA — Cartridge chemistry wash solution,
Chemistry parameters,
Chemistry print name, defining, 3-6
Chemistry, configuring,
Clearing chemistries,
Chloride Electrode tip, Replace,
Closed Tube Sampling
CO
2
alkaline buffer reagent straw and line, bleaching
CO
2
measuring electrode membrane, 9-74
Replace,
Wrinkled,
Constituent code,
Control,
–
Bar codes,
Constituent code,
Definition,
Deleting,
Fields,
File number,
Printing,
QC chart,
QC file list,
QC summary,
Creatinine clearance results
Critical Result Rerun,
CTS — Closed Tube Sampling,
CTS (Closed Tube Sampling)
1-Blade Narrow CTS option,
1-Blade Thick CTS option,
Blade count,
CTS Count,
CTS Auto-Gloss,
CUPs lamp and sensor calibration, 9-29
Cuvette reaction system,
Cuvette washer probe, inspect
Blocked probe,
Cuvette washing
Cuvette water blank status, 10-6
Cuvette wiper
Reinstall,
Cuvettes
Automated wash all cuvettes, 9-110
D
Sample programs,
Date/time setup,
Deleted results,
Deleting,
Control,
Critical result rerun,
QC data point,
Index
Drugs of abuse testing (DAT),
E
Editing
EIC — Electrolyte injection cup, 9-2
–
ISE service,
Electrolyte injection cup (EIC), 1-15
,
Enzyme validator,
Enzyme verification,
Error detection
Error detection limits,
Exit check criteria,
,
Expanded user defined chemistry feature,
Extinction coefficients,
Immediate reporting,
Instrument commands,
Intended use,
ISE — Ion selective electrode (flow cell
ISE drain cleaning, six-month
Drain top,
Drip screen,
ISE reference solution,
K
Keyboard,
L
Labels,
Language/keyboard, selection, 3-29
Levey-Jennings,
Log fields,
LPIA (large particle immuno assay)
I
F
Failure messages, calibration,
File number,
Flow cell flush kit,
Flow cell, flushing
ISE service,
–
H
Home,
Host specifications
See Host Interface Specifications Manual (P/
N A16150)
Hydropneumatic system,
Icons,
M
,
Main screen and program structure,
Maintenance,
Manual
Conventions,
Scope,
Manual assignments,
MC — Modular chemistry,
MC components, reassemble,
Modem,
Modular chemistries (MC),
Basic components,
Modular reagents
Index-3
Index
Index-4
Check levels,
Modules,
Modules, enable/disable,
N
O
ORDAC,
Auto ORDAC,
P
Panels,
Patient results
Critical results rerun,
PHOSm, cleaning precipitate
Protein precipitate,
Photometer assembly,
Post run summary,
Potassium and calcium electrode tips
Replacing, six-month
ISE service,
Removing/installing,
Power Subsystem Status,
Pre run summary,
,
Precautions,
–
Prime,
Printers,
Printing,
Control,
Data,
QC chart,
Priority
Position,
Priority load,
Probes, clean,
Batch,
Manual assignments,
ORDAC,
Rack/cup position,
Sample ID,
Sample status,
Pushers,
Q
QAP Disk,
Quad-ring
CO
2
measuring electrode,
Potassium and calcium electrode,
,
Quality Assurance Program (QAP)
Copy to disk feature,
Quality control (QC),
Printing QC bar code assignments,
QC chart,
QC file list,
Displaying,
R
Status,
Reaction type,
Reagent handling system, CC, 1-17
Reagent parameters,
Loading,
Reagent status
Sorting reagent status
Days left,
Tests left,
Reagent syringe,
See also Sample and reagent syringes,
replacing three-month
Recalling results
Index
Printing,
Replicates,
Reports,
Reserved racks, assigning,
Reset,
Restore,
,
Retainer nut,
Review results,
Reviewing,
S
Sample
Handling system,
Programming
Type
Default,
Sample and reagent syringes, replacing threemonth
Plunger rods,
Sample syringe,
MC sample syringe,
Serum index
Service
See also Metering Manual (P/N 967259)
Setup,
Setup
Screens,
Silicone compound,
Smart modules
Status,
Sodium Azide preservative,
Software version,
Specifications, system
Statistical summary report,
Status
Alarm/Annunciator,
See also System status,
Status-cycle count,
Stop print,
Surfaces and covers, cleaning,
System hazards
Moving parts,
System Status,
T
Tables,
Beckman Coulter defined chemistries,
Predefined special calculations,
Predefined special formulas,
Timed urine results
Constants and factors,
Total protein cup maintenance,
Touch Screen Calibration,
U
Update,
UPS (Uninterruptible Power Supply),
User,
Index-5
Index
User defined reagents
Defining,
Deleting,
Inserting,
Minimum operating requirements,
Removing,
Setup,
V
Version information,
Version upgrade,
W
Warnings, reagent and calibration status,
Wash Concentrate II,
Waste B, pause/resume,
Wavelength
Primary,
Secondary,
Westgard rules,
Wheel
Index-6
www.beckmancoulter.com
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
•
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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Table of contents
- 3 Revision History
- 5 Safety Notice
- 27 Contents
- 33 Introduction
- 37 CHAPTER 1
- 37 System Description
- 37 System Description
- 37 Introduction
- 37 Operational Conditions
- 37 Shipping Damage
- 37 Installation
- 38 Clearances
- 38 Sunlight and Drafts
- 38 Drain
- 38 Power Requirements
- 39 Environmental Conditions
- 40 Water Requirements
- 40 Other System Specifications for IEC-1010 Compliance
- 41 System Components
- 41 DxC Systems
- 42 Sample Handling System
- 42 Introduction
- 43 Sample Racks
- 44 Rack ID Labels
- 45 Autoloader/Offload Track
- 45 Priority Load Position
- 46 Priority Load Button
- 46 Pushers
- 46 Sample Gate
- 46 Shuttle
- 46 Bar Code Reader (Sample)
- 47 1-Blade Thick CTS (Closed Tube Sampling) or 1-Blade Narrow CTS Cap Piercer Assembly (optional)
- 48 Sample Carousel
- 48 Modular Chemistry (MC) System
- 48 Introduction
- 49 Reagent Storage Area
- 49 Reagent Bar Code Reader (Modular)
- 50 Ratio Pump
- 51 Electrolyte Injection Cup (EIC)
- 52 Flow Cell Assembly
- 53 Chemistry Reaction Modules (Basic Components)
- 53 Cartridge Chemistry (CC) Reagent Handling System
- 53 Introduction
- 54 Reagent Cartridges
- 55 Reagent Carousel and Reagent Bar Code Readers
- 56 Reagent Probe Assembly
- 56 Reagent Mixer Assembly
- 56 Reagent Mixer Wash Cup
- 57 Cuvette Reaction System
- 57 Introduction
- 57 Reaction Carousel
- 58 Photometer Assembly
- 58 LPIA (Large Particle Immuno Assay)
- 59 Cuvette Wash Station
- 60 Hydropneumatic System
- 60 Introduction
- 61 Function
- 62 Operation and Control Components
- 62 Operator Controls
- 63 Main Screen and Program Structure
- 63 Main Screen
- 64 Status Functions
- 66 Menu Bar Icons and Program Structure
- 74 Recall Results for On-board Samples
- 74 Accessing the Help System
- 74 Print Data From a Screen
- 75 Rack Status Area
- 75 STAT Highlighting
- 75 Additional Function Keys
- 75 Request a Sample for Unload
- 75 Sample Log
- 78 Pre Run Summary
- 78 Post Run Summary
- 79 Theory of Operation
- 79 Introduction
- 79 Cartridge Chemistries (CC)
- 79 Cartridge Chemistry (CC): Sample and Reagent Processing
- 79 Cartridge Chemistry: Calibration Theory
- 79 Introduction
- 80 Endpoint and First-Order Chemistries
- 80 Endpoint and First-Order Calibration Formulas
- 86 Non-Linear Chemistries
- 86 Non-Linear Calibration Formulas
- 89 Drugs of Abuse Testing (DAT) Chemistries
- 89 Enzyme Verification
- 89 Modular Chemistry: Calibration Theory
- 89 Calibration Theory
- 89 Calibration Error Detection
- 89 Modular Chemistries (MC)
- 90 Cartridge Chemistry: Principles of Measurement
- 90 Spectrophotometric Methods
- 90 Beer's Law
- 91 CHAPTER 2
- 91 Preparing Samples for Analysis
- 91 Routine Operation Overview
- 91 Daily Procedure
- 92 Preparing Samples for Analysis
- 92 Minimum Sample Volume
- 92 Sample Racks
- 93 Sample Preparation by Container Type
- 94 Bar Code Labeling
- 95 Sample Tubes Validated for CTS
- 95 Closed Tube Sampling (CTS)
- 97 How to Use Reserved Racks
- 97 When NOT to Use a Reserved Rack
- 97 Reserved Racks
- 97 Reserved Racks for HbA1c, or IBCT
- 98 Assigning or Reassigning Reserved Racks
- 99 CHAPTER 3
- 99 System Setup Options
- 99 Overview
- 99 Introduction
- 100 Password Setup
- 100 Introduction
- 101 Defining/Editing Password Setup
- 102 Auto Serum Index/ORDAC
- 102 Auto ORDAC
- 102 Auto Serum Index
- 103 Configuring the Chemistry Menu
- 103 Introduction
- 103 Configuring a Beckman Coulter Chemistry
- 103 Configuring a User Defined Chemistry (UDR)
- 104 Defining Chemistry Print Name
- 104 Inserting a Chemistry
- 104 Deleting a Chemistry
- 108 Beckman Coulter Defined Chemistries with Units and Precision
- 111 Setting the Default Sample Type
- 111 Introduction
- 111 Setup
- 111 Date/Time Setup
- 111 Introduction
- 111 Setup
- 112 Demographics Setup
- 112 Introduction
- 112 Setup
- 112 Patient Results - Immediate Reporting Setup
- 112 Introduction
- 112 Immediate Patient Results Reporting to Host and/or Printer
- 113 Panels
- 113 Introduction
- 113 Defining, Editing and Deleting Panels
- 113 Selecting a Default Panel
- 114 Replicates
- 114 Introduction
- 114 Setup
- 114 Report Setup
- 114 Introduction
- 115 Setup
- 115 Reportable Ranges Setup
- 115 Introduction
- 115 Analytical Range
- 115 Instrument Printable Range
- 116 Reportable Range
- 116 Suppress Results Option
- 117 Reference/Critical Ranges Setup
- 117 Reference and Critical Ranges
- 117 Sample Comments Setup
- 117 Introduction
- 117 Setup
- 118 Special Calculations Definition
- 118 Introduction
- 119 Beckman Coulter Predefined Special Calculations Defaults
- 119 Beckman Coulter Predefined Special Calculation Formulas
- 121 Timed Urine and Creatinine Clearance Results
- 121 Introduction
- 121 Calculation Constants and Factors
- 121 Version Information
- 121 Introduction
- 121 Setup
- 122 Units/Precision Setup
- 122 Introduction
- 122 Setup
- 122 User Defined Chemistries Setup
- 122 Introduction
- 122 Setup
- 123 Bar Code Setup
- 123 Introduction
- 123 Setup
- 124 Maximum Sample Program Age
- 124 Introduction
- 124 Setup
- 124 Reserved Racks/Obstruct Detect
- 124 Introduction
- 125 Setup
- 125 Disable Service Monitor
- 125 Introduction
- 125 Setup
- 126 Host Communications
- 126 Introduction
- 127 Setup
- 127 Language/Keyboard Setup
- 127 Introduction
- 127 Setup
- 128 Printer Setup
- 128 Introduction
- 128 Setup
- 128 Service Setup
- 128 Introduction
- 128 Enabling Service Setup
- 128 Disabling Service Setup
- 129 System Configuration
- 129 Introduction
- 129 View/Edit System Configuration
- 129 Version Upgrade
- 129 Introduction
- 129 Setup
- 130 Status Alarm/Annunciator
- 130 Introduction
- 130 Setup
- 130 Chemistry Update
- 130 Introduction
- 130 Setup
- 131 Auto Generation of Control
- 131 Introduction
- 131 Setup
- 133 CHAPTER 4
- 133 Reagent Load/Calibration
- 133 Reagent Load
- 133 Introduction
- 134 Pre-Run Checklist
- 134 Rgts/Cal Screen Overview
- 135 Sort Reagent Status
- 136 Load/Unload Reagent
- 142 Reagent Parameters
- 144 System Calibration
- 144 Introduction
- 144 Load a Calibrator Diskette
- 145 Calibrator Assignment
- 146 Calibration Status
- 146 Introduction
- 146 Calibration Status Messages
- 147 Reagent and Calibration Status Warnings
- 147 Introduction
- 147 Conditions that Cause a Calibration Status Warning
- 148 Request a Calibration
- 148 Calibrate DxC Chemistries With Bar Code Labels
- 149 Calibrate DxC Chemistries Using Assigned Calibrator Racks
- 150 Cancel a Calibration Request
- 150 Calibration Failure Messages
- 150 Introduction
- 150 CC Subsystem Calibration Failure
- 151 MC Subsystem Calibration Failure
- 151 Within-Lot Calibration
- 151 Introduction
- 151 Within-Lot Calibration Frequency
- 151 Enable Within-Lot Calibration
- 153 Within-Lot Calibration Status Screen
- 154 Within-Lot Designations
- 154 Within-Lot Calibration Limitations
- 155 Enzyme Validator
- 155 Introduction
- 156 Calibration Override
- 156 Introduction
- 156 Override a Calibration
- 156 Remove Cal Overridden Status
- 157 Chemistry Bypass
- 157 Introduction
- 157 Bypass a Chemistry
- 157 Remove a Bypassed Status
- 158 Extend Calibration Time
- 158 Introduction
- 158 Extend Calibration Time
- 158 Remove an Extended Status
- 159 Calibration Acceptance Limits
- 159 Introduction
- 159 View Calibrator Acceptance Limits
- 160 Calibrator Set Point Modifications
- 160 Introduction
- 160 Modify Calibrator Set Points
- 161 Slope Offset Adjustment
- 161 Introduction
- 162 Slope Offset Recommendations
- 163 Reprint Calibration Reports
- 163 Introduction
- 163 Reprint Current Calibration Reports
- 164 Reprint Previous Calibration Reports
- 165 CHAPTER 5
- 165 Quality Control
- 165 Quality Control
- 165 Introduction
- 165 Quality Control Program
- 165 Determination of QC Flags
- 166 Accuracy and Precision Flags
- 167 Flags Generated on Printed QC Reports
- 167 Additional QC Precision Rules
- 168 Define a Control
- 168 Introduction
- 168 Special or Unique Control Samples
- 168 Control Description
- 168 Define a Control
- 170 Delete Controls from Definition Screen
- 171 Control ID Assignments
- 171 Introduction to Assignment of QC Bar Codes
- 171 Assignment of QC Bar Codes
- 171 Print Bar Code Assignments
- 171 Run Control Samples
- 171 Introduction
- 172 Run Control Samples With Bar Code Labels and Auto Generation of Control Enabled
- 172 Manually Programming Control Samples
- 173 Edit a Control Definition
- 173 Introduction
- 173 Edit Precautions
- 174 Modify Assigned Mean, Assigned SD or Constituent Code
- 174 Add Chemistry(ies)
- 175 Remove Chemistry(ies)
- 176 Review a Control Definition
- 176 Introduction
- 176 Review a QC
- 176 Delete a Control
- 176 Introduction
- 177 Delete a Control
- 177 Print QC Ranges
- 178 QC File List
- 178 Introduction
- 178 QC File Definition
- 178 Display QC File Lists
- 179 QC Summary
- 179 Introduction
- 179 Accessing the QC Summary
- 180 QC Chart (Levey-Jennings)
- 180 Introduction
- 180 Accessing QC Charts
- 182 QC Log
- 182 Introduction
- 182 Accessing QC Logs
- 183 Delete a Data Point
- 184 Add a QC Action Log Comment
- 185 Quality Assurance Program (QAP) “Copy To Disk” Feature
- 185 Introduction
- 185 Create a QAP Disk
- 187 Archive QC
- 187 Introduction
- 187 Archive QC
- 188 Review Archived Data
- 188 Introduction
- 188 Review Archived Data
- 191 CHAPTER 6
- 191 Sample Programming and Processing
- 191 Overview
- 191 Introduction
- 192 Prior to Programming
- 192 Introduction
- 193 Rack Status
- 194 Verify Sample Carousel Status: Main Screen
- 194 Identify Samples
- 194 Introduction
- 195 Sample ID
- 195 Limitations
- 195 Valid Characters for Entries
- 196 Create Sample IDs
- 196 Sample Programming and Processing
- 196 Processing Bar Coded Samples
- 197 Manually Assigning Rack and Position
- 197 Processing Samples Manually
- 199 Add Tests or Rerun a Sample
- 200 Additional Programming Information
- 200 Chemistry Identifiers
- 200 Enter a Dilution Factor
- 200 Programming a Manual ORDAC
- 200 Programming Samples for Serum Index
- 201 Batch Programming
- 202 Clear Samples
- 202 Introduction
- 203 When to Clear Samples
- 203 Range of Sample IDs
- 204 Procedure for Clearing Samples
- 205 CHAPTER 7
- 205 Results Recall
- 205 Overview
- 205 Introduction
- 205 Limitations
- 206 Recall Results by Sample ID
- 207 Recall Results by Rack and Position
- 208 Recall Results by Patient ID
- 208 Recall Results by Run Date/Time
- 209 Display Recalled Results
- 210 Edit Critical Rerun Result
- 210 Introduction
- 210 Delete Critical Rerun Result
- 211 Print Recalled Results
- 212 Send Results to the Host
- 212 Introduction
- 212 Send Data
- 212 Absorbance Versus Time
- 212 Recall Data
- 214 Statistical Summary Report
- 214 Introduction
- 214 Additional Information
- 214 Display Statistical Summary
- 215 CHAPTER 8
- 215 User Defined Reagents
- 215 Overview
- 215 Requirements and Precautions
- 215 Minimum Requirements for Operation
- 216 User Defined Reagent Cartridges
- 217 User-Defined Reagent Setup
- 217 Defining a User-Defined Reagent
- 218 Edit a User-Defined Reagent
- 218 Chemistry Parameters
- 218 Define a Chemistry Test Name
- 218 Reaction Type
- 219 Units
- 219 Precision
- 219 Reaction Direction
- 220 Math Model
- 220 Primary Wavelength
- 220 Secondary Wavelength
- 221 Calculation Factor
- 221 Number of Calibrators
- 222 Calibrator Values
- 222 Calibration Time Limit
- 222 Processing Parameters
- 222 First Inject: Component
- 222 First Inject: Dispense Volume
- 223 Second Inject: Component
- 223 Second Inject: Dispense Volume
- 223 Second Inject: Add Time
- 224 Third Inject: Component
- 225 Third Inject: Dispense Volume
- 225 Third Inject: Add Time
- 225 Sample Volume
- 225 Blank Read Times
- 226 Initial Read Times
- 226 Reaction Read Times
- 227 Usable Result Range
- 227 Error Detection Limits
- 227 Reagent Blank (Absorbance or Rate)
- 227 Reaction (Absorbance or Rate)
- 228 Initial Rate High and Substrate Depletion
- 228 Multipoint Spans
- 229 Wavelength Selection
- 229 Introduction
- 229 Primary Wavelength Selection
- 229 Secondary Wavelength Selection
- 230 Summary
- 230 Determination of Extinction Coefficients
- 230 Introduction
- 230 Option 1
- 231 Option 2
- 231 Exit Check Criteria
- 231 Introduction
- 231 Wavelengths
- 231 Calibration
- 232 Blanking
- 232 Measurement
- 232 Volumes
- 233 User Defined Reagent Removal
- 233 Remove a User Defined Reagent
- 234 Expanded User Defined Chemistry Feature
- 234 Introduction
- 234 Cal Save
- 235 ORDAC
- 236 On Board Dilution
- 237 CHAPTER 9
- 237 Maintenance
- 237 Overview
- 237 Introduction
- 237 Basic Laboratory Practice
- 238 Common Abbreviations
- 238 Maintenance Schedule
- 239 Twice Weekly Maintenance
- 239 Weekly Maintenance
- 239 Monthly Maintenance
- 239 Two-Month Maintenance
- 239 Three-Month Maintenance
- 240 Four-Month Maintenance
- 240 Six-Month Maintenance
- 240 Electronic Maintenance Log
- 240 Feature Summary
- 241 Access the Scheduled Log Feature
- 241 Screen Description
- 241 Help
- 241 Procedure
- 243 Twice Weekly Maintenance
- 243 Introduction
- 243 Clean Sample and Reagent Probes, Mixers, EIC, and Flow Cell
- 245 Weekly Maintenance
- 246 Check Reagent Levels
- 246 Replace Cuvette Wiper
- 248 Clean Total Protein and Albumin Cup Modules (DxC 800 Only)
- 250 Clean Probes (Exterior)
- 252 Clean Flow Cell, Cups and CC Probes/Mixers (Automated)
- 253 Check Chloride Calibration Span
- 253 Monthly Maintenance
- 253 Replace Alkaline Buffer
- 257 Adjust the Fluid Level of the Alkaline Buffer Damper Assembly
- 259 Clean All Cup Modules
- 261 BUNm/UREAm Electrode Maintenance (DxC 800 Only)
- 265 Calibrate Lamps and Sensor
- 267 Clean Mixers
- 268 Replace CTS Blade (1-Blade Narrow CTS Option)
- 272 Two-Month Maintenance
- 272 Replace CTS Blade/Wick (1-Blade Thick CTS Option)
- 277 Change/Clean Air Filters
- 279 Three-Month Maintenance
- 279 Replace Syringe Plungers
- 284 Four-Month Maintenance
- 284 Clean the MC Reagent Lines
- 288 Six-Month Maintenance
- 288 Replace Calcium and Potassium Electrode Tip
- 294 Replace Glucose Sensor
- 299 As-Needed/As-Required Maintenance
- 300 Introduction
- 300 Action Log
- 300 Replace the Chloride Electrode Tip
- 304 Replace the Sodium Measure/Reference Electrode
- 309 Replace the CO2 Membrane
- 316 Clean the EIC Port
- 322 Clean the CO2 Alkaline Buffer Lines
- 324 Clean the ISE Drain
- 327 Flush the Flow Cell (Manual)
- 330 Clean the ISE Flow Cell Using Clenz Solution
- 333 Flush the Sample and Reagent Probe
- 335 Replace the Sample and Reagent Probe
- 339 Clean the CC Sample Probe, Reagent Probes and Mixers
- 340 Clean the MC Sample Crane and Collar Assembly
- 341 Clean the Precipitate in PHOSm (DxC 800 Only)
- 342 Inspect the Cuvette Washer Probe
- 345 Wash All Cuvettes With System Wash
- 346 Wash the CC Reagent Cuvettes with CCWA
- 347 Clean the Work Surfaces
- 348 Decontaminate the Sample Racks
- 348 Decontaminate the Instrument
- 352 Replace the CTS Wick
- 361 Replace ISE Drain Pump Tube
- 365 CHAPTER 10
- 365 System Status and Commands
- 365 Overview
- 365 System Status
- 365 Introduction
- 365 Show Status Summary
- 365 Possible Status Messages
- 366 What to Do If There is an Error
- 366 Return to Status Summary
- 366 Status-Cycle Count
- 366 Introduction
- 366 Show Cycle Count
- 367 Cycle Count Description
- 367 Temperatures
- 367 Introduction
- 367 Show Temperature Status
- 368 Power Subsystems
- 368 Introduction
- 368 Show the Power Subsystem Status
- 368 Hydropneumatics Subsystem
- 368 Introduction
- 369 Show the Hydropneumatics Subsystem Status
- 369 What to Do If a Parameter is Out of Limits
- 369 ICS/Smart Modules
- 369 Introduction
- 369 Show the ICS/Smart Module Status
- 370 Cuvette Water Blank Status
- 370 Introduction
- 370 Show the Cuvette Water Blank Status
- 370 What to Do if a Cuvette is Dirty
- 371 CTS Tracking
- 371 Introduction
- 371 Do Not Clear the Sample ID Manually
- 371 Show the CTS Tracking Status
- 371 What to do if a Parameter is Out of Limits
- 372 Instrument Commands
- 372 Commands
- 372 Home
- 372 Introduction
- 372 Why Use Home
- 373 Home
- 373 Pause
- 373 Introduction
- 374 When to Use Pause
- 374 When NOT to Use Pause
- 374 Pause
- 375 Stop Print
- 375 Introduction
- 375 How Stop Print Works
- 375 Stop Print
- 376 Shutdown
- 376 Introduction
- 376 Shutdown
- 377 ON/OFF Switch
- 377 Line Converter Device
- 377 DC Output Power Supplies
- 377 Uninterruptible Power Supply (UPS)
- 378 Power Cord Connections
- 378 System Power On/Boot
- 378 Introduction
- 378 Power Up Sequence
- 378 Full Boot
- 379 After Boot-up
- 379 Reset
- 379 Pause/Resume Waste B
- 379 Introduction
- 379 Pause Waste B
- 380 Resume Waste B
- 380 Enable/Disable Modules
- 380 Introduction
- 381 Disable Modules
- 381 Enable Modules
- 382 Unload All
- 382 Introduction
- 383 Unload All Racks
- 385 CHAPTER 11
- 385 Utilities
- 385 Overview
- 385 Prime
- 385 Introduction
- 386 Accessing Prime
- 387 Stopping a Prime
- 387 Priming All Subsystems
- 388 Priming CC Subsystems
- 389 Priming Hydropneumatic Subsystems
- 389 Priming MC Subsystems
- 390 Maintenance
- 390 Additional Information
- 390 Event Log
- 390 Introduction
- 391 Event Information
- 391 Select Specific Event Classes
- 392 Information Options
- 392 Show Events
- 393 Additional Information
- 393 Copy to a Disk
- 394 Specify the Date/Time
- 395 Clear Events
- 395 Print an Event Log
- 396 Alignment/Diagnostics/PVTs
- 396 Diagnostics and Alignment
- 396 Additional Information
- 396 Metering
- 396 Reagent Metering
- 396 Metered-Use Instruction Manual
- 396 Modem
- 397 Backup/Restore
- 397 Introduction
- 397 System Parameters
- 397 Alignment Data
- 397 Backup the System
- 398 Restore the System
- 400 Touch Screen Calibration
- 400 Introduction
- 400 Parallax
- 400 Alignment Data
- 400 Procedure
- 401 Index
- 408 Related Documents
- 411 Contents
- 417 CHAPTER 12
- 417 Troubleshooting Calibration and Result Errors
- 417 Calibration Errors
- 417 Introduction
- 417 Calibration Error Checking
- 417 Calibration Error Flags
- 418 MC Calibration
- 418 Overview
- 418 MC Calibration Checks
- 418 Back-to-Back
- 419 Calibrator Range (High/Low)
- 419 DAC
- 420 Sample/Reference Deviation
- 420 Span
- 420 Calibration Reports
- 423 Linear Calibration
- 423 Overview
- 423 Back-to-Back
- 423 Calibrator Range (High/Low)
- 424 Span
- 424 Linear Calibration Report
- 426 Non-Linear and Multipoint Calibrations
- 426 Overview
- 426 Non-Linear Calibration Checks
- 426 Multipoint Span
- 426 Recovery
- 427 Severe Recovery
- 427 Sensitivity
- 427 Severe Sensitivity
- 427 Math Errors
- 427 Calibration Report
- 429 Troubleshooting Result Errors
- 429 Result Errors
- 430 Error Codes and Definitions
- 430 Result Errors and Codes
- 433 Error Code - Definitions
- 439 Common Error Messages and Corrective Actions
- 439 Online Manual Links
- 481 Glossary
- 491 Index
- 498 Related Documents