Linear Calibration

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Linear Calibration | Manualzz

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:

Added statement to

Environmental Conditions Precautions

Added

Patient Results

Added

Quality Control

Added

Sample Integrity

CHAPTER 3, System Setup Options:

Added footnotes to Table 3.3, UniCel DxC 600 Predefined Special Calculation Formulas and

Table 3.4, UniCel DxC 800 Predefined Special Calculation Formulas

CHAPTER 9, Maintenance:

Added Twice Weekly bullet to

Maintenance Schedule

Added

Twice Weekly Maintenance

Added bullets to

Weekly Maintenance

Added

Twice Weekly Maintenance

procedure

Added cleaning statement to

Weekly Maintenance

Added statement to

Clean Flow Cell, Cups and CC Probes/Mixers (Automated)

Deleted CC Probes/Mixers Cleaning (Manual Program) procedure iii

Revision History

iv

A13914AF

Safety Notice

Summary of Hazards

Introduction

This section summarizes the hazards associated with the DxC System. Individual hazards associated with a specific procedure in this manual are included in

Warnings

or

Cautions

within the procedures for that task. Please read this section and the following

Summary of Precautions

before operating the system.

Bar Code Reader Hazards

Do not tamper with or remove the housing of any bar code reader because of the laser-based nature of the readers and the potential hazard of looking directly at laser light. When the instrument is

running, homing, or in diagnostics, the laser may be ON. At all other times the laser is OFF.

Biohazardous Materials Hazards

A011460L.EPS

Observe all laboratory policies or procedures which pertain to handling of infectious and pathogenic materials.

Closed Tube Sampling (CTS) Cap Piercer Assembly Hazards/Biohazards

The Cap Piercer contains a razor sharp blade assembly that has been exposed to potentially biohazardous fluids. The points of the Blade are very sharp and extend below the Wash Tower. Stay away from the bottom of the Wash Tower. To prevent injury or exposure, do not touch the Points of the Blade and always wear gloves.

CTS Auto-Gloss Handling Hazards

Be careful when handling the bottle of CTS Auto-Gloss. Prevent spills. This lubricant is extremely slippery and difficult to clean from the floor.

Electrical Ground Hazards

Do not under any circumstances operate the system until an electrical ground is provided and the power cord is properly connected to the ground.

A13914AF v

Safety Notice

Summary of Hazards

Electric Shock Hazards

Replacement or servicing of any components where contact with bare, live hazardous parts could occur, possibly resulting in electric shock, should only be performed by qualified service personnel.

Flammable Materials Hazards

Do not use this system in the presence of flammable materials.

Hazardous/Biohazardous Substances Hazards

When handling a spill of blood or other potentially hazardous substances, clean up the spill by using a 10% bleach solution, or use your laboratory decontamination solution. Then follow your laboratory procedure for disposal of hazardous materials. If the UniCel DxC system needs to be decontaminated, call your Beckman Coulter Service Representative for assistance.

ISE Module Hazards

Pinch hazard. Keep fingers clear of the ISE module as you lower it.

Moving Parts Hazard

CAUTION

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

456161-B

A011459L.EPS

Do not place hands near any moving part while the system is operating. Lower and/or close protective guards and covers during operation.

No Foam Reagent Pressurization Hazard

The No Foam container is pressurized during system operation and must be properly depressurized prior to servicing to avoid sudden depressurization and potential exposure of the skin or eyes to the

No Foam solution. To release the air pressure, disconnect the white quick connector located at the supply side of the container. If inhaled, move exposed individual to fresh air. If skin or eye contact with the solution occurs, flush the affected area thoroughly with water for at least 15 minutes. In both cases seek medical attention. Refer to the No Foam Material Safety Data Sheets (MSDS) for additional information.

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

Summary of

Hazards section of this chapter, and should always conform to the procedures and safety warnings

throughout this manual.

If the equipment is used in a manner not specified by Beckman Coulter, Inc., the protection provided by the equipment may be impaired.

Waste B Disposal Hazards/Biohazards

The Waste B collection bottle contents are considered biohazardous and should be handled appropriately.

A13914AF 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

Hazards

before operating the system.

AccuSense Glucose Sensor Precautions

Whenever the sensor is replaced, reaction cup and stir bar cleaning is recommended. Remove the sensor prior to removing stir bar. To prevent damage to the glucose oxygen sensor membrane tip, do not insert the stir bar removal tool, applicator stick, or any other object into the glucose reaction cup unless the sensor has been removed. Do not touch membrane tip of the AccuSense glucose oxygen sensor.

Air Filter Cleaning Precautions

Do not place a damp filter back on the system. Residual moisture may damage the system.

Alkaline Buffer Stability Precautions

The alkaline buffer reagent is stable for one month on the system. However, if a color change from pink to a lighter shade of pink should occur, replace the alkaline buffer with a fresh bottle of reagent.

Aqueous Calibrator Precautions

Repetitive refrigeration of Synchron aqueous calibrators may facilitate crystal formation. When removed from refrigerated storage, these calibrators should remain at room temperature. After the calibrator is opened it is stable for the period claimed in the accompanying package insert.

Bar Code Label Precautions

A misread label can cause one sample ID to be read as another. The laboratory’s process for printing, placing, and meeting all bar code specifications is important to achieve highly accurate readings.

Always follow the bar code label specifications to avoid misread labels.

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

, iii

Safety Notice

, v

Introduction

, xxxiii

CHAPTER 1:

System Description

, 1-1

System Description

, 1-1

Operational Conditions

, 1-1

System Components

, 1-5

Sample Handling System , 1-6

Modular Chemistry (MC) System , 1-12

Cartridge Chemistry (CC) Reagent Handling System , 1-17

Cuvette Reaction System

, 1-21

Hydropneumatic System , 1-24

Operation and Control Components

, 1-26

Main Screen and Program Structure , 1-27

Theory of Operation

, 1-43

Cartridge Chemistry: Calibration Theory , 1-43

Modular Chemistry: Calibration Theory , 1-53

Cartridge Chemistry: Principles of Measurement , 1-54

CHAPTER 2:

Preparing Samples for Analysis

, 2-1

Routine Operation Overview , 2-1

Preparing Samples for Analysis

, 2-2

How to Use Reserved Racks , 2-7

xxvii

Contents

CHAPTER 3:

System Setup Options

, 3-1

Overview , 3-1

Password Setup , 3-2

Auto Serum Index/ORDAC , 3-4

Configuring the Chemistry Menu , 3-5

Setting the Default Sample Type , 3-13

Date/Time Setup , 3-13

Demographics Setup , 3-14

Patient Results – Immediate Reporting Setup

, 3-14

Panels

, 3-15

Replicates

, 3-16

Report Setup , 3-16

Reportable Ranges Setup

, 3-17

Reference/Critical Ranges Setup , 3-19

Sample Comments Setup

, 3-19

Special Calculations Definition , 3-20

Timed Urine and Creatinine Clearance Results

, 3-23

Version Information , 3-23

Units/Precision Setup , 3-24

User Defined Chemistries Setup

, 3-24

Bar Code Setup

, 3-25

Maximum Sample Program Age , 3-26

Reserved Racks/Obstruct Detect

, 3-26

Disable Service Monitor , 3-27

Host Communications

, 3-28

Language/Keyboard Setup , 3-29

Printer Setup

, 3-30

Service Setup

, 3-30

System Configuration , 3-31

Version Upgrade

, 3-31

Status Alarm/Annunciator , 3-32

Chemistry Update , 3-32

Auto Generation of Control

, 3-33 xxviii

CHAPTER 4:

Reagent Load/Calibration

, 4-1

Reagent Load , 4-1

System Calibration

, 4-12

Load a Calibrator Diskette , 4-12

Calibrator Assignment

, 4-13

Calibration Status , 4-14

Reagent and Calibration Status Warnings , 4-15

Request a Calibration , 4-16

Calibration Failure Messages

, 4-18

Within-Lot Calibration , 4-19

Enzyme Validator , 4-23

Calibration Override , 4-24

Chemistry Bypass , 4-25

Extend Calibration Time

, 4-26

Calibration Acceptance Limits , 4-27

Calibrator Set Point Modifications , 4-28

Slope Offset Adjustment

, 4-29

Reprint Calibration Reports , 4-31

CHAPTER 5:

Quality Control

, 5-1

Quality Control

, 5-1

Define a Control , 5-4

Control ID Assignments

, 5-7

Run Control Samples

, 5-7

Edit a Control Definition

, 5-9

Review a Control Definition , 5-12

Delete a Control

, 5-12

Print QC Ranges , 5-13

QC File List , 5-14

QC Summary , 5-15

QC Chart (Levey-Jennings)

, 5-16

QC Log

, 5-18

Quality Assurance Program (QAP) “Copy To Disk” Feature , 5-21

Archive QC

, 5-23

Contents

xxix

Contents

Review Archived Data

, 5-24

CHAPTER 6:

Sample Programming and Processing

, 6-1

Overview , 6-1

Prior to Programming

, 6-2

Identify Samples , 6-4

Sample Programming and Processing

, 6-6

Additional Programming Information , 6-10

Clear Samples , 6-12

CHAPTER 7:

Results Recall

, 7-1

Overview , 7-1

Recall Results by Sample ID , 7-2

Recall Results by Rack and Position

, 7-3

Recall Results by Patient ID

, 7-4

Recall Results by Run Date/Time

, 7-4

Display Recalled Results , 7-5

Edit Critical Rerun Result , 7-6

Print Recalled Results

, 7-7

Send Results to the Host

, 7-8

Absorbance Versus Time , 7-8

Statistical Summary Report

, 7-10

CHAPTER 8:

User Defined Reagents

, 8-1

Overview , 8-1

Requirements and Precautions , 8-1

User-Defined Reagent Setup

, 8-3

Chemistry Parameters , 8-4

Processing Parameters

, 8-8

Error Detection Limits , 8-13

Wavelength Selection

, 8-15

Determination of Extinction Coefficients

, 8-16

Exit Check Criteria

, 8-17

User Defined Reagent Removal

, 8-19

Expanded User Defined Chemistry Feature

, 8-20 xxx

Contents

CHAPTER 9:

Maintenance

, 9-1

Overview , 9-1

Electronic Maintenance Log , 9-4

Twice Weekly Maintenance

, 9-7

Weekly Maintenance , 9-9

Check Chloride Calibration Span , 9-17

Monthly Maintenance , 9-17

Two-Month Maintenance , 9-36

Three-Month Maintenance

, 9-43

Four-Month Maintenance , 9-48

Six-Month Maintenance , 9-52

As-Needed/As-Required Maintenance

, 9-64

CHAPTER 10:

System Status and Commands

, 10-1

Overview , 10-1

System Status

, 10-1

Status-Cycle Count

, 10-2

Temperatures

, 10-3

Show Temperature Status

, 10-3

Power Subsystems

, 10-4

Hydropneumatics Subsystem , 10-4

ICS/Smart Modules , 10-5

Cuvette Water Blank Status

, 10-6

CTS Tracking

, 10-7

Instrument Commands

, 10-8

Home

, 10-8

Pause

, 10-9

Stop Print , 10-11

Shutdown , 10-12

System Power On/Boot , 10-14

Pause/Resume Waste B , 10-15

Enable/Disable Modules , 10-16

Unload All

, 10-18 xxxi

Contents

CHAPTER 11:

Utilities

, 11-1

Overview , 11-1

Prime

, 11-1

Maintenance , 11-6

Event Log , 11-6

Alignment/Diagnostics/PVTs

, 11-12

Metering , 11-12

Modem

, 11-12

Backup/Restore

, 11-13

Touch Screen Calibration

, 11-16

CHAPTER 12:

Troubleshooting Calibration and Result Errors

, 12-1

Calibration Errors

, 12-1

MC Calibration

, 12-2

Linear Calibration

, 12-7

Non-Linear and Multipoint Calibrations , 12-10

Troubleshooting Result Errors , 12-13

Error Codes and Definitions , 12-14

Error Code – Definitions , 12-17

Common Error Messages and Corrective Actions , 12-1

Glossary

, Glossary-1

Index

, Index-1

Related Documents

xxxii

Introduction

Intended Use

The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).

Scope of This Manual

This manual covers basic operating instructions and maintenance guidelines for UniCel DxC 600/

800 Systems. Detailed operation, maintenance, and troubleshooting instructions are not included in this manual. In addition, medical and diagnostic interpretation, or the clinical significance of chemistries or assays are not discussed. Refer to the reference materials in the Related Documents section for detailed information.

Manual Conventions

This manual uses the following printed and visual cues to guide the user in responding to printed directions.

Table 1 Conventions Used in this Manual

Convention

Combination Keys

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

.

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

Figure 1.3

.

There is also space for 25 sample racks in the offload track as they are removed from the Sample

Carousel upon completion.

IMPORTANT

When loading racks onto the autoloader, make sure that they are placed firmly down into the autoloader.

Figure 1.3 Sample Loading Area

1

2 3 4 5 6 7

A011870P.EPS

1. 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

Figure 1.3

.

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

Figure 1.3

.

Bar Code Reader (Sample)

CAUTION

Do not tamper with or remove the housing of the Sample Bar Code Reader.

The Bar Code Reader is a Class II fixed-beam laser scanner. It is used to read the rack bar code, the sample bar code (if present), and the background bar codes as the rack travels past. The rack bar code and sample bar code (if present) are used to identify the sample and link it to the appropriate sample programming.

There are two background bar codes that are used to determine whether a rack position is empty or occupied, and if occupied, whether the sample is in a cup or tube.

Refer to

Documentation Symbols

in the Safety Notice

section, for a description of the CAUTION labels for the bar code reader.

1-10

A13914AF

System Description

Sample Handling System

1

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

Figure 1.4

. Under

normal operation, eight of the Sample Carousel positions are available for routine processing and two positions are reserved for priority racks.

Figure 1.4 Sample Carousel Area

1

2

3

4

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

Figure 1.5

.

When this reader is held up to the label of one of the modular reagents and the trigger is pressed, the identity of the reagent, the lot number and reagent volume are automatically entered into the reagent load screen.

A13914AF

1-13

System Description

Modular Chemistry (MC) System

Ratio Pump

The Ratio Pump is a motor-driven, multicylinder, positive-displacement pump used to deliver the necessary reagents to the ISE flow cell. Refer to

Figure 1.6

. It consists of a three-step piston housed in three, stacked, independent cylinders.

Figure 1.6 DxC 800 Ratio Pump

1 2 3 4 5

6

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

Figure 1.9

. Unique design elements of the modules are described under the specific module headings later in this section.

Figure 1.9 Basic Components of Modules (Ex: Albumin)

2

3

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

to Figure 1.11

.

The storage compartment is refrigerated and fan-cooled to maintain a temperature of +5°C (±3°C).

The Bar Code Reader, (refer to Figure 1.11

), situated near the front of the Cartridge Chemistry

reagent access door, scans each label during the loading of reagent cartridges. Only the reader for the selected carousel is active. An audible signal acknowledges successful reading of the label.

Figure 1.11 CC Dual Carousels with Two Bar Code Readers

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

.

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

Figure 1.12

.

Reagent Mixer Wash Cup

The Mixer Wash Cup sprays the mixer with diluted wash solution while the mixer moves up and down in the cup.

1-20

A13914AF

System Description

Cuvette Reaction System

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

Figure 1.13

), supports a total of 125 cuvettes. Each cuvette

is glass with a 0.5 cm path length and is approximately 30 mm high. The cuvettes are non-disposable and have an indefinite life-span on the instrument. Cuvettes only need replacement if they are damaged. (They remain under warranty for two years.)

A13914AF

1-21

System Description

Cuvette Reaction System

Figure 1.13 Reaction Carousel Area (Typical – Cover Removed)

2

3

1

A015909P.EPS

1. LPIA Module (optional)

2. Reaction Carousel

3. Photometer

Photometer Assembly

Attached to the reaction carousel support frame is the Photometer assembly. This consists of a xenon pulse lamp, a discrete 10-position silicon-diode detector array, a monochromator housing unit, and associated electronic circuitry. Refer to

Figure 1.13

.

As each cuvette passes through this optics station during a spin cycle, the xenon lamp is flashed and the resulting light beam travels through the opposing sides of the square cuvette.

LPIA (Large Particle Immuno Assay)

The optional LPIA module uses a photometric detection system for large particle immuno assays.

This assembly is attached to the reaction carousel support frame to the left of the photometer

assembly, near the sample carousel. Refer to Figure 1.13

. It has two printed circuit boards, an LED

(light-emitting diode) and a photodetector. Communication with the system software is through fiber optic cables.

1-22

A13914AF

System Description

Cuvette Reaction System

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

Figure 1.15

and

Figure 1.16

. When fully extended, the drawer locks open. To close, lift up on the metal tabs, located on each side of the bottom runner of the hydropneumatic unit, and push the drawer inward.

Figure 1.15 DxC 800 Hydropneumatics (right side)

6

5

4

3

2

1

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

.

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

1-26

A13914AF

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

A13914AF

1-27

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

Figure 1.17

, appears on the blue bar at the top right side of the

Operator screens. The indicator to the right of the label shows communication activity between the instrument and the host computer. A blue bar indicates that the host is sending information. A green bar indicates that the host is receiving information.

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

Figure 1.17

just above the Menu Bar (4). It shows the current state of the system: either Running,

Standby or Stopped. When both the Modular Chemistry (MC) and the Cartridge

Chemistry (CC) functions have the same status, a single status indicator appears.

When the statuses of these components are different, the MC Status is shown on the left, and the CC Status appears on the right. For example, Running/Standby would indicate that the MC side is Running, and the CC side is in Standby mode.

1-28

A13914AF

System Description

Main Screen and Program Structure

1

Sample Status Indicators

Refer to

Figure 1.17

. When monitoring sample status, a sample status icon appears in front of listed samples. Samples are listed in a rack status box directly below the sample status icon legend (5). The sample statuses shown are as follows:

Table 1.14 Sample Status Indicators

Status Indicator

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.

A13914AF

1-29

System Description

Main Screen and Program Structure

Menu Bar Icons and Program Structure

Near the top of the Operator screens, a series of icons on the touch screen provide access to each of the major functional areas of the system (4) (refer to

Figure 1.17

).

Figure 1.18 Program Structure (Main, Samples)

1-30

A13914AF

Figure 1.19 Program Structure (Results, Rgts/Cal)

System Description

Main Screen and Program Structure

1

A13914AF

1-31

System Description

Main Screen and Program Structure

Figure 1.20 Program Structure (QC, Setup)

1-32

A13914AF

Figure 1.21 Program Structure (Setup - continued)

System Description

Main Screen and Program Structure

1

A13914AF

1-33

System Description

Main Screen and Program Structure

Figure 1.22 Program Structure (Setup - continued)

1-34

A13914AF

Figure 1.23 Program Structure (Utils)

System Description

Main Screen and Program Structure

1

A13914AF

1-35

System Description

Main Screen and Program Structure

Figure 1.24 Program Structure (Utils – continued)

1-36

A13914AF

Figure 1.25 Program Structure (Utils – continued, Status, Instr Cmd, and Help)

System Description

Main Screen and Program Structure

1

A13914AF

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.

1-38

A13914AF

System Description

Main Screen and Program Structure

1

Rack Status Area

These boxes,

Figure 1.17

(6), represent the ten possible rack locations on the Sample Carousel. As

each rack is loaded, the rack number is displayed at the top of the Rack Status box. All sample IDs on the rack are listed below the rack number. The Sample Status icons described earlier indicate sample status.

STAT Highlighting

Any sample programmed as a STAT is highlighted in a yellow rack status box on the

Main

screen.

Additional Function Keys

Other functions may also be accessed through the

Main

screen.

Results F1

- Retrieves results for samples that are In Progress on the system.

Unload F2

- Requests particular racks to be unloaded at the next possible opportunity.

Log F8

- Lists errors detected on samples, for example, incomplete tests, host query timeout, duplicate sample ID, programming conflict. If the error is logged, the

Log F8

key is highlighted in yellow. The yellow highlight disappears when the key is selected. The error will stay in the

Sample Log screen for 12 hours.

Pre Run Summary F9

- Lists reagent and calibration status, as well as sample programming needs.

Post Run Summary F10

- Lists error conditions which have occurred on the system, including suppressed results and no sample detected.

These functions are covered more thoroughly in the following sections.

Request a Sample for Unload

To unload racks that contain specific samples perform the following procedure.

1

Select the rack to unload. The rack is highlighted.

2

Select

Unload F2

. The rack is offloaded at the earliest opportunity.

Sample Log

The sample log feature provides a method to review the status of any incomplete patient and control samples that have been off the system for less than 12 hours.

A13914AF

1-39

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

)

PRINT

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).

1-40

A13914AF

A13914AF

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.

1-42

A13914AF

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.

A13914AF

1-43

System Description

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Chemistries

Calibration of endpoint and first-order rate chemistries involve the use of a single-level calibrator solution or a two-level calibrator kit. Each analyte in the calibrator solution has a known concentration value associated with it. With each new lot of calibrator solution, the values are transferred from disk and stored in memory for later use in the calibration procedure.

For most calibrated cartridge chemistries, the system will set calibration factors based on four calibrator replicates per calibrator level. The instrument will determine and discard the highest and lowest of the four replicates. The remaining two values are called the usable calibrator replicates.

All four replicates will appear on the report but the average of the two usable replicates is used to determine the calibration factor.

For other chemistries, calibration is based on two calibrator replicates per calibrator level. No replicates are discarded. The average value of the calibrator replicates is used to determine the calibration factor.

Endpoint and First-Order Calibration Formulas

The calibration factor is determined by using one of the following equation sets where reaction and blank are used from the usable replicates.

1-44

A13914AF

A13914AF

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.

1-46

A13914AF

A13914AF

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

A13914AF

A13914AF

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

1-50

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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.

1-51

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

1-52

A13914AF

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

Table 2.2

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 (

Figure 2.1

) describes how to place the label on a sample tube and how to place the tube into a sample rack.

Figure 2.1 Bar Code Label Placement

4

1

2

3

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.

2-6

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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.

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CHAPTER 3

System Setup Options

Overview

Introduction

This chapter summarizes the 29 System Setup options depicted on the

Setup

screens shown in

Figure 3.1

and

Figure 3.2

below:

Figure 3.1 Setup Screen (scrolled to the top)

E011951S.EPS

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3-1

System Setup Options

Password Setup

Figure 3.2 Setup Screen (scrolled to the bottom)

E015931S.EPS

For detailed step-by-step instructions on using the System Setup option, refer to the UniCel DxC

Synchron Clinical Systems Reference Manual.

Password Setup

Introduction

The Password Setup option allows the operator to:

Assign up to 100 user names and their passwords

Assign Administrator or Operator level privileges to each user name

Define/edit or delete user name/password setup

Enable/disable security for accessibility to certain system functions and setups

The following features may be password secured:

Results, Edit

Rgts/Cal, Modify Set Points

Rgts/Cal, Slope/Offset Adjustment

Rgts/Cal, Within-Lot Calibration

Rgts/Cal, Enzyme Validator

QC

Setup

Utils, Clear Event Log

3-2

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System Setup Options

Password Setup

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.

3-4

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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

A13914AF

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.

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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

Print

to print, or

OK

to exit.

7

Repeat Steps 2–5 in this section to request load lists for samples in the Incomplete and Rerun status. For Step 5:

Select Incomplete for a list of samples.

Select Rerun for a list of samples.

8

Look for the chemistry to be de-configured,

DIGN

, in each load list and clear these samples.

Refer to the UniCel DxC Synchron Clinical Systems Reference Manual, Clearing Samples section for information on how to clear sample programming.

Remove the Chemistry from the Quality Control (QC) Program

If a control is defined solely for that chemistry and is no longer needed, the entire control definition should be deleted.

1

Select

QC

from the menu bar.

2

Select the control to be cleared.

3

Select

Delete F3

.

4

The following message appears to confirm the clearing of the selected control:

"All QC files for the control will be deleted. Archiving is suggested. Delete this control?"

Select

OK

to delete the control.

5

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,

Clear Samples . If not, patient samples are purged during rollover at 10,000 Patient IDs or 150,000 results,

whichever comes first.

Beckman Coulter Defined Chemistries with Units and Precision

Table 3.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units

and Precision

Beckman Coulter Defined Chemistry

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

A13914AF

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.

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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

Table 3.5

following lists the Host communications parameters, the options of each, and the default

values.

Table 3.5 DxC Host Communications Parameter Options for ASTM, LX20/DxC, CX7 Compatible

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.

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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

Disable Service Monitor

in this chapter for instructions.

3-30

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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.

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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

Figure 4.1

. Red highlighted chemistries will not run. Yellow highlighted chemistries

will run, but check the reagent volume before starting. Load new reagent if the reagent volume is insufficient to run pending tests.

Figure 4.1 Reagent Load/Calibration Screen

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

4.3

, 4.4

and

4.5

.

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

Figure 4.4

, and

Figure 4.5

.

5

Remove the reagent from the system. It is not necessary to scan the bar code of the reagent bottle when removing it.

6

Place new bottle on the system.

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Reagent Load/Calibration

Reagent Load

4

CAUTION

To avoid contamination, do NOT touch the reagent straw.

NOTE

The No Foam container shown in

Figure 4.6

(2) is refilled by pouring a fresh bottle of No Foam

solution into the empty container on the instrument.

Refer to Figure 4.6

and refill the No Foam container as follows:

Wipe dust from around cap (4).

Vent the No Foam container (2) by disconnecting the quick connector (3) at side of container.

NOTE

The connector may be located on either side of the No Foam container.

Using the No Foam Container Cap Wrench, loosen the cap (4) from top of lid (1) by turning the wrench counterclockwise.

NOTE

Make sure the wrench is flush with the No Foam cap.

Using the hand-held bar code reader, scan the bar code on new No Foam bottle.

Pour bottle contents into No Foam container (2).

Wipe off any spillage.

Replace cap (4) and hand tighten. Do not use the wrench to tighten the cap.

Reattach connector (3).

Figure 4.6 No Foam Container (DxC 800 shown)

4

1

3

2

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

Figure 4.7

and

Figure 4.8

. Additionally, the system retains calibration status of loaded and unloaded cartridges.

Reagents can be loaded while the system is Running or in Standby.

Check reagent box or Reagent Preparation Card for reagent preparation instructions.

Caps must be removed from the cartridge before loading.

Check cartridges for bubbles in the reagent compartments before loading. Use an applicator stick to remove bubbles.

Figure 4.7 CC Reagent Information

3

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

Figure 4.9

.

As the cartridge is moved in front of the bar code reader, a beep will indicate that the bar code is read. Check the screen to verify reagent data is removed from the position selected.

If the bar code does not read, manually clear the position. To manually clear, select

Clear F1

.

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.

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A13914AF

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

Figure 4.1

. Then select the pull-down menu in the Cal

Options box to select the desired cal option. The cal options are:

Load calibrator diskettes

Calibrator acceptance limits

Modify set points

Slope/offset adjustment

Within lot calibration

Enzyme validator

Calibration override

Bypass chemistry

Extend calibration time

Print cal report

Load a Calibrator Diskette

Serum based calibrators require a calibrator diskette to be loaded on the system. The calibrator diskette is loaded only one time per lot number.

To check what lot number is currently loaded on the system, select the

Rgts/Cal

icon from the menu bar, then select

Options F6

. Use the pull-down menu to select “Calibrator Acceptance

4-12

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Reagent Load/Calibration

Calibrator Assignment

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

Figure 4.10

.

Cancel a Calibration Request

1

Select

Rgts/Cal

from the menu bar.

2

Select the appropriate requested and assigned chemistries to be canceled.

3

Select

No Cal F8

to cancel calibration request.

Chemistries currently selected and programmed for calibration may be canceled only if the calibration is not yet in progress.

Calibration reports for a given calibrator do not print until all calibrations are complete for each chemistry requested, unlike sample and control results, which print on a cup-by-cup basis.

Calibration Failure Messages

Introduction

If there is a failure during calibration, for modular chemistry (MC) or cartridge chemistry (CC), there is a pop-up message which shows:

The chemistry that failed and

The associated error code(s).

After a failure message, the operator can:

Stop the calibration or

Continue the calibration.

CC Subsystem Calibration Failure

The CC subsystem warns the operator of a failed calibration. If a chemistry fails, a pop-up message appears after a completed calibrator level. The message includes:

Calibrator name

4-18

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Reagent Load/Calibration

Within-Lot Calibration

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

Figure 4.11

.

5

Select

Add

to move the chosen Chemistry to the Selected Chemistries area.

6

Repeat Step 5 for other chemistries, if appropriate.

7

Select

OK

to enable the within-lot option for the selected chemistry.

OR

Select

Cancel

to exit without enabling.

Figure 4.11 Within-Lot Calibration Dialog Box

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

to Figure 4.11

.

2

Select

Status

.

The within-lot chemistries appear by the within-lot calibration time remaining, the oldest calibration date listed first. The lot number and the serial number of the cartridges are shown.

3

Select

Close

to exit the pop-up window and return to the Within-Lot Calibration screen.

Figure 4.12 Within-Lot Calibration Status Screen

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E015927S.EPS

4

Select

Cancel

to return to the

Reagent Status

and

Calibration Status

screens.

4-21

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

Additional

Information

below) equivalent answers for selective enzymes, or to obtain IFCC/DGKCh equivalent answers for the non-IFCC/non-DGKCh formulation enzymes.

The Synchron Enzyme Validator set is a human serum, albumin-based value assigned material and is used like a calibrator.

The feature can be turned on or off for applicable chemistries; the default is off.

The Enzyme Validator Kit includes diskettes which provide set points for the selective enzymes.

IMPORTANT

When the enzyme reagent is configured and loaded, and the Enzyme Validator feature turns on, Enzyme Validator ID assignments and calibration requests can be performed in the same manner as any calibrator.

1

Select

Rgts/Cal

from the menu bar.

2

Select

Options F6

.

3

Select

Enzyme Validator

.

4

Select a desired Configured Chemistry name from the pull-down menu.

5

Select

Add

to move the chosen Chemistry to the Selected Chemistries area.

6

Repeat Step 5 for other chemistries, if appropriate.

7

Select

OK

to enable the Enzyme Validator option.

OR

Select

Cancel

to exit without enabling the option.

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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:

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5-1

Quality Control

Quality Control

X = the individual control result

X = the assigned mean for the control

SD = the assigned standard deviation for the control

Z =

X - X

SD

E014425L.EPS

Each time a control result is received, the Z-score is calculated. If the Z-score is less than ± 2 SD, the result is within the assigned control range (the assigned mean ± 2 assigned standard deviations) and is considered acceptable.

NOTE

Results are flagged at time of run. Flagging is not changed if the operator modifies the assigned mean and/or SD.

Accuracy and Precision Flags

The DxC uses the following Westgard rules for evaluation of QC data.

1-2S: Result Between ± 2SD and ± 3SD From the Assigned Mean

If the result is between ± 2 and ± 3 standard deviations from the assigned mean, the result:

is flagged as > 2SD on the QC Log report.

appears in yellow on the QC LOG and QC CHART screens.

is highlighted in a pop-up note on the monitor as the system is running.

1-3SD: Result Greater Than 3SD From the Assigned Mean

If the result is greater than ± 3 SD from the assigned mean, the result:

is flagged as > 3SD on the QC Log report.

appears in red on the QC LOG and QC CHART screens.

is included in a real-time pop-up window as the system is running.

2-2S and R-4S: Results Between 2 SD and 3 SD as Compared to the Previous Result

In addition, the Z-score for the current result is compared with the Z-score of the previous result in the same QC file. If both Z-scores are beyond 2 SD on the same side of the assigned mean, the current result receives an "Accuracy" flag on the QC Log report; this flag signifies a violation of the 2-2S rule. These values appear red in the QC log and QC chart.

If the two results being compared are greater than 2 SD on opposite sides of the assigned mean, the current result receives the "Precision" flag on the QC Log report, signifying a violation of

R-4S rule. These values appear red in the QC log and QC chart.

Results Greater Than 4 SD From the Assigned Mean

Results greater than 4 SD are included in the QC Log and QC Chart, but are not used to calculate statistics.

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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.

Refer to Figure 5.1

.

4-1S Within or Across: Last Four Results of One or Two Levels of Control Were More than 1 SD

From the Mean on the Same Side

This rule judges the result out-of-control if the last four results from one or two levels were more than 1 SD from the mean in the same direction.

10X Within or Across: Last Ten Results of One or Two Levels of Control Were All on the Same

Side of the Mean

This rule judges the result out-of-control if the last ten results from one or two levels were all on the same side of the mean.

Figure 5.1 QC Accept/Reject Chart Using Westgard Rules

Control

Data

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

Display QC File Lists in this

chapter to obtain a list of used QC File numbers.

Assigned Mean Type the assigned mean for the chemistry level and lot. The system adds zeroes to the end of the number to show maximum precision

(X.XXX).

Assigned SD Type the assigned standard deviation, ±1SD. The system adds zeroes to the end of the numbers to show maximum precision (X.XXX).

Constituent Code This field is optional. If desired, type the constituent code.

10

Select

Done F10

to leave the definition screen and to save the control.

Minimum requirements to save a control definition are control name, lot number, sample type,

QC file number and one chemistry selection.

If the control definition is not complete, a warning message will appear specifying which information is missing. The operator has the option of exiting the control definition screen or returning to the definition screen to add the missing information.

If exiting the definition screen without filling in the missing fields

, the following will occur:

Exiting the screen without QC File Number not fully defined will delete any chemistry missing this information.

If returning to the definition screen

, verify that all of the following definition fields have been filled for any control or requested chemistry:

Control Name

Control Lot Number

QC File Number

Delete Controls from Definition Screen

Selecting the

Delete F3

key deletes all definitions for the current control definition.

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Quality Control

Control ID Assignments

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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5-7

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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5-9

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

Display QC File Lists

in this chapter to obtain a list of used QC File numbers.

Assigned Mean Type the assigned mean for the chemistry level and lot. The system adds zeroes to the end of the number to show maximum precision

(X.XXX).

Assigned SD Type the assigned standard deviation, ±1SD. The system adds zeroes to the end of the numbers to show maximum precision (X.XXX).

Constituent Code This field is optional. If desired, type the constituent code.

5

Select

Done F10

to leave the definition screen and to save the control.

Remove Chemistry(ies)

1

Select

QC

from the menu bar.

2

Select the control number beside the

Control Name

and select

Define F2

.

3

Select

Chems F1

. A list of configured chemistries appears. Remove chemistries by selecting and removing from the list. Use the scroll bar to access all chemistries.

Select

OK

to leave the selection screen and save the chemistry selections.

Select

Cancel

to exit without changing the chemistry selection.

4

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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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.

5-17

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

Table 6.1

, for a description of each Sample Status. Press

(

Page Up

)

or

(

Page Down

)

to view additional rack numbers.

4

The following functions are available:

To clear a rack or several racks:

Select

Clear F1

.

Type rack or Sample ID and select

OK

.

Select

OK

again to confirm deletion of sample programs.

To return to Sample Programming without making changes:

Select

Cancel F9

.

To select a rack to program a sample:

Select a rack with an available position.

Enter the manual assignment information.

Select

OK

to save.

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6-3

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

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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,

Calibrator Assignment

, for information on calibrator identification.

IMPORTANT

When clearing data, to verify exactly what will be cleared, first view the load list for the intended range of samples. The samples recalled on the load list are identical to the samples that will be cleared.

6-12

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Sample Programming and Processing

Clear Samples

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

Range of Sample IDs

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

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CHAPTER 7

Results Recall

Overview

Introduction

Results Recall allows patient and control results to be recalled, reviewed, updated, and printed.

Results can be recalled, viewed, and printed by:

individual Sample ID or a list of Sample IDs

rack and position

Patient ID or

run date and time.

Limitations

The system keeps a maximum of 150,000 results and 10,000 sample programs. When these limits are exceeded, the system chronologically overwrites existing results.

When a sample program is cleared, results cannot be recalled by Sample ID. Results may still be recalled by other demographic information.

To avoid retrieving inconsistent sample data, recall results using Sample ID or verify correct Sample

ID when recalling by rack and position. Results for the last sample run in a specific rack/cup position will be recalled. Results for the new sample is available for recall only after the system begins to run the new assignment.

CAUTION

If a newly assigned sample that has not been run is recalled, the Results for the previous sample run in that position is shown or transmitted.

When using the Results Recall feature, do not leave any samples with tests In

Progress on the screen. This prevents the rack from being removed from the system and a printout of the Results from being produced.

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7-1

Results Recall

Recall Results by Sample ID

Recall Results by Sample ID

Results can be recalled by an individual Sample ID and/or by a range of Sample IDs.

Individual Sample IDs and/or a range of Sample IDs can be entered. Results may be reviewed and/ or sent to the host. Follow the steps below to enter Sample IDs for recall.

1

Select

Results

from the menu bar.

2

To input an individual Sample ID:

Type the Sample ID desired for recall in the

Sample ID

field.

To input a range of Sample IDs:

Type the Sample ID at the beginning of the range in the

From

field.

Press

(

Tab

)

.

Type the Sample ID at the end of the range in the

To

field.

Press

(

Enter

)

.

To input, select a function button from the bottom of the screen to select a desired output option:

Results F1

- to view results on the screen.

Sum F7

- to send statistical summary to printer.

Host F8

- to send results to the host.

Print F10

- to send results to a printer.

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Results Recall

Recall Results by Rack and Position

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 ,

Print Recalled Results , and

Send

Results to the Host

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.

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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.

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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

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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.

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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).

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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

Print

.

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

Results to the Host

section).

NOTE

The maximum range of samples that can be recalled is set to 100. If there are more than 100 samples in the range, the following message appears:

"Exceeds maximum limit. Not all samples will print."

3

Select

Sum F7

from the

Recall Results By

dialog box.

A Statistical Summary Report is printed.

7-10

A13914AF

CHAPTER 8

User Defined Reagents

Overview

The user may define up to 100 chemistries on the UniCel DxC 600/800 using an endpoint or rate, and calibrated or non-calibrated methodology. A set of parameters must be defined which fully characterizes an analyte. When the parameters are defined, they are stored in memory according to the test name designated in System Setup. Chemistries can then be configured on the test selection menu for programming along with the Beckman Coulter-defined chemistries. When configured, quality control, reference ranges, and special calculations may be used with these configured chemistries.

In addition, up to 10 of the 100 user defined chemistries may be configured with the Expanded User

Defined Chemistry feature. Refer to the end of this chapter for further information.

NOTE

The sample type for UDR must be serum, plasma, CSF or urine. Do not use any other sample type.

Requirements and Precautions

Minimum Requirements for Operation

The following parameters must be defined to use the User-Defined Reagent feature.

chem name

primary wavelength

secondary wavelength (except for the LPIA Module)

reagent dispense volume

sample volume

blank start and blank end read times

reaction start and reaction end read times.

If additional parameters are defined, Exit Check criteria must be passed. Refer to

Exit Check Criteria

in this chapter.

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8-1

User Defined Reagents

Requirements and Precautions

User Defined Reagent Cartridges

The user-defined reagent is placed in generic, non-bar code labeled, three-compartment cartridges that are loaded onto the system manually. These cartridges are available in a box of 12 (PN 442835).

The label on the cartridge should be marked with the reagent name and expiration date. The maximum and minimum fill volumes, required to allow for accurate level sensing, are indicated in the table below.

Table 8.1 Fill Volumes for Accurate Level Sensing

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

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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

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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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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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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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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

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Third Inject: Component

This designates the compartment of the cartridge which will be pipetted third. If Third Inject is not used, the default compartment selection is None and should not be modified.

Table 8.19 Options for the Third Inject Component

None, A, B, or C

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User Defined Reagents

Processing Parameters

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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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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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

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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

.

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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

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CHAPTER 9

Maintenance

Overview

Introduction

Maintenance on the UniCel DxC System should be performed by trained personnel to insure continued, optimal performance and to reduce unnecessary service calls. Minimum training requires that the operator read the Maintenance procedures.

The Scheduled Maintenance Log feature allows the system to keep track of what maintenance is needed, when it is needed, and who performed the procedure. It also provides the capabilities of alerting the operator to the maintenance that is due, and to the maintenance procedures that have been performed and reviewed.

Basic Laboratory Practice

The maintenance frequencies established in this manual are based on processing approximately 400 samples/day.

The number of samples processed by the system, combined with the nature of the samples, may require the stated maintenance frequencies to be adjusted in some laboratories.

A start-up prime of the various subsystems may be necessary if the system has been idle for more than approximately 8 hours. Refer to

CHAPTER 11, Utilities

for priming procedures. Reviewing reagent status prior to running the instrument is standard laboratory practice.

As with any laboratory equipment, the exterior of the DxC system should be kept clean. Any spills should be cleaned up promptly. Spills that may be caused by leaking reagent lines or fittings should be investigated. Refer to

As-Needed/As-Required Maintenance in this chapter for cleaning

procedures.

Certain procedures in this manual require the use of a grounded wrist strap while the procedure is being performed. The strap portion should be placed around the wrist. The wire portion can be connected to the system in one of the following ways:

Alligator Clipped: Wrist straps with an "alligator" clip should be clamped onto the metal frame of the system. To access, open either the left or center door. If desired, the doors may be closed after the clip is attached to the metal frame.

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9-1

Maintenance

Overview

Banana Plug Insert: Wrist straps with a "banana" plug must be inserted into the chassis ground next to the Stop button on the front of the system (See

Figure 9.1

.)

Figure 9.1 Chassis Ground

IMPORTANT

The system does not autoprime in Maintenance mode. After completing a maintenance procedure, or if a procedure is aborted, exit the Maintenance menu to resume autoprime and return the system to Standby.

Common Abbreviations

CC – Cartridge Chemistry side of the system

MC – Modular Chemistry side of the system

ISE – Ion Selective Electrode (Flow Cell Module)

EIC – Electrolyte Injection Cup

CCWA – Cartridge Chemistry Wash Solution

CTS – Closed Tube Sampling

Maintenance Schedule

CAUTION

If the DxC is connected to the automation line, make sure the DxC is in Manual mode before performing any DxC maintenance procedure.

The UniCel DxC System requires maintenance to operate correctly. Maintenance is scheduled at the following intervals:

Twice Weekly

Weekly

9-2

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Maintenance

Overview

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

Backup/Restore

instructions. You can also print and store Electronic Maintenance data if required by laboratory policy.

Access the Scheduled Log Feature

1

Select:

Utils

from the menu bar,

2 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

for initial and date entry all at one time. Refer to Initial and Date Check Box/Initial and Date Button

in this chapter.

Initial and Date Check Box/Initial and Date Button

This function allows the operator to select the procedure and enter the initials of the person who performed the procedure and the date it was performed. When a maintenance procedure is completed, select the

Initial and Date

checkbox. To complete the entry of this information, select the

Initial and Date

button.

When a procedure has had initials and date entered, the maintenance counter resets for the appropriate time interval.

Sensor/Electrode Number

When you complete the

Initial and Date

button entries for six month maintenance, you must enter a sensor/electrode number. Record the number found on the sensor or electrode before you install it.

Date Performed Field

Shows the date entered by the operator on which the maintenance was performed.

Initials Field

Shows the initials entered by the operator of the person who performed the maintenance.

Days Left Field

Shows the number of days left until a maintenance procedure is due. The word DUE is shown in this area highlighted in yellow when a procedure is actually due or past due to be performed.

A yellow DUE indication will NOT prevent the system from being run.

IMPORTANT

If a maintenance procedure was never entered into the system by inputting initials and date, only the

DUE

field is yellow. The pathway is not activated. This gives the operator the option to not use the Scheduled Maintenance Log feature. There is no way to deactivate the yellow DUE highlighting at the

Scheduled Maintenance Log

screen level.

Counts Left Field

Certain maintenance procedures are better tracked by counting the number of samples run through the system. This column shows a countdown of the number of samples that can be run until the maintenance procedure is due to be performed. If no numbers appear in this column the procedure is tracked by time not count.

History

The History icon provides a stored history of maintenance performance with dates and initials for the procedure selected.

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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.

Print

When a time period (Month and Year) is entered, this button prints all of the maintenance tabs and associated maintenance data.

Approve

This option allows a separate review and approval by allowing the reviewer to enter their initials and the review date into the fields shown.

Maintenance Action Legend

This area gives a brief description of the actions that should be taken when a maintenance procedure is completed.

Done

This option exits the Scheduled Maintenance Log feature and returns the operator to the

Maintenance

screen.

Twice Weekly Maintenance

Introduction

Perform Twice Weekly Maintenance on the same days each week. These procedures prevent contamination build-up on the instrument.

Clean Sample and Reagent Probes, Mixers, EIC, and Flow Cell

Clean the MC Sample Probe, CC Sample Probe, Reagent Probes and Mixers, EIC and Flow Cell twice weekly to prevent sample, reagent, or system and hardware errors. You can reduce erratic chemistry results such as drift and noise, or chemistry performance problems such as imprecision when you keep a regular cleaning schedule.

Materials Required

Diluted Clenz Solution (PN 664090) freshly prepared. Add four drops of Clenz Solution to an empty 2 mL cup, fill to the 2 mL line with saline and mix.

0.9% Saline (Buffered Blood Bank Saline Can Not be Used)

CCWA cartridge PN 657133 (Wash Solution)

Sample racks

2mL sample cups

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9-7

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

Check Reagent Levels

Clean Total Protein and Albumin Cup Modules (DxC 800 Only)

Clean Probes (Exterior)

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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

Cell

.

Check Chloride Calibration Span

Check Reagent Levels

Check the levels of these MC reagents: Wash Concentrate II, No Foam and CTS Auto-Gloss (CTS option only). To check the levels, perform the following procedure:

1

Select

Rgts/Cal

from the menu bar.

2

Select the

Down Arrow

to review the second page screen.

3

To access the modular reagents, open the left and middle doors.

NOTE

The CTS Auto-Gloss bottle is in a bracket on the inside of the middle door.

4

Examine the reagent levels in the bottles and compare them with the percentages on the screen

(

Wash, No Foam

and

Auto-Gloss

).

5

If the volume shown does not match the actual reagent volume, enter the correct volume for each reagent in the

Vol

field.

NOTE

A pop-up message appears when approximately 10% and 5% of an MC reagent remains.

6

If necessary, load a new bottle of reagent.

Be careful when handling the bottle of CTS Auto-Gloss or No Foam. Prevent spills. These solutions are extremely slippery and difficult to clean from the floor.

Refer to CHAPTER 4, Reagent Load/Calibration,

Reagent Load in this manual.

7

Close the left and middle doors.

Replace Cuvette Wiper

With constant use, the cuvette wiper can deteriorate and become stained and torn. The cuvette wiper should be changed weekly or as needed to maintain the cleanliness and integrity of the cuvette.

9-10

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Maintenance

Weekly Maintenance

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

Basic

Laboratory Practice in the beginning of this chapter.

1

Press the

STOP

button on the instrument to place the system into Stopped state.

The probes are ready for manual maintenance when system status is Stopped.

2

Wipe the outside and bottom of any exposed portions of the sample and reagent probes, and all of the cuvette wash station probes. Use a lintless tissue moistened with 70% isopropyl alcohol or a 70% isopropyl alcohol pad.

NOTE

Use a separate pad for each probe.

Do not pull or exert pressure on probes, which can cause bending.

9-14

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Maintenance

Weekly Maintenance

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)

This weekly maintenance is superceded by the mandatory Twice Weekly procedure Clean Sample and Reagent Probes, Mixers, EIC, and Flow Cell .

To clean the flow cell, MC Sample Probe, selected cup modules, CC Sample Probe, reagent probes and mixers follow the procedure below.

Materials Required:

Diluted Clenz Solution freshly prepared by adding 4 drops of Clenz Solution

(PN 664090) to an empty 2 mL sample cup. Fill to 2 mL line with 0.9% saline and mix.

2 mL sample cup of 0.9% saline, required for CC Probes/Mixers.

CCWA cartridge (PN 657133), required for CC Probes/Mixers. CCWA must have at least 25 tests available.

Cleaning Procedure

1

Load CCWA cartridge.

2

Select

Utils

from the menu bar.

3

Select

2 Maintenance

.

4

Select

10 Clean Flow Cell, Cups and CC Probes/Mixers

.

5

Follow the instructions on the screen.

NOTE

All components are selected by default. All components except the flow cell can be deselected if you don’t want to clean them.

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

Reprint Calibration Reports

.

2

Refer to page 2 of the calibration report. Check the CL span value at the bottom of the page. If the value is <1800, replace the electrode tip when it is convenient to your work load. See

Replace the Chloride Electrode .

Monthly Maintenance

Replace Alkaline Buffer

Adjust the Fluid Level of the Alkaline Buffer Damper Assembly

Clean All Cup Modules

BUNm/UREAm Electrode Maintenance (DxC 800 Only)

Calibrate Lamps and Sensor

Clean Mixers

Replace CTS Blade (1-Blade Narrow CTS Option)

Replace Alkaline Buffer

The following procedure describes how to replace the Alkaline Buffer reagent and the In-line air filters.

1

Loosen the two Phillips screws on the ISE module cover and remove the cover.

2

Release the locking pin (1) on the ISE module and lift the module until it clicks into a raised, locked position. The locking pin is located on the left side of the ISE module on DxC 800 Systems as shown in

Figure 9.7

. The locking pin is located on the right side of the ISE module on DxC 600

Systems.

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9-17

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

CHAPTER 4, Reagent Load/

Calibration

in this manual.

11

Select

Done F10

when finished.

12

While priming with the alkaline buffer reagent, check the peri-pump tubing and line for leaks or other problems. Correct as needed.

13

Adjust the fluid level of the Alkaline Buffer Damper Assembly. Refer to the

Adjust the Fluid Level of the Alkaline Buffer Damper Assembly procedure.

CAUTION

Pinch hazard. Keep fingers clear of the ISE module as you lower it.

14

Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module is lowered.

15

Reinstall the ISE module cover.

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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)

Figure 9.10

, leading from the damper to the flow cell, is oriented on top.

3

Prime alkaline buffer five times or as many times as necessary to fill the damper one-half full.

Access alkaline buffer priming.

Select:

Utils

from the menu bar,

1 Prime

,

MC F4

,

ISE 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

.

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

Figure 9.13

.

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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 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

Adjust the Fluid Level of the

Alkaline Buffer Damper Assembly

procedure (in this chapter) can be performed.

2

Reinstall the ISE module cover.

3

Calibrate all applicable cup chemistries.

Clean Mixers

Wipe the mixers monthly to clean any buildup or discoloration that may accumulate over time.

CAUTION

To prevent damage due to electrical static discharge (ESD), wear the wrist ground strap when you perform this procedure. For further instructions, refer to

Basic

Laboratory Practice

in the beginning of this chapter.

Gently but thoroughly wipe the outside of both mixers (1) and (2) of

Figure 9.17

using 70% isopropyl alcohol and lintless tissue or with a 70% isopropyl alcohol swab. Inspect mixers for scratches or nicks and replace if necessary.

Figure 9.17 CC Sample and Reagent Mixers

1 2

A015939P.EPS

A13914AF

1. CC Sample Mixer

2. CC Reagent Mixer

9-31

Maintenance

Monthly Maintenance

Replace CTS Blade (1-Blade Narrow CTS Option)

Refer to Figure 9.18

. Replace the Cap Piercer blade approximately once a month. If the system runs

>500 samples per day, replace the blade more frequently. The blade count records the number of caps pierced by the blade. Refer to

CHAPTER 10, System Status and Commands

.

CAUTION

The Cap Piercer blade is very sharp and has been exposed to potentially biohazardous fluids. To prevent injury or exposure, do not touch the points of the blade and wear gloves.

Figure 9.18 Cap Piercer Blade

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

Figure 9.20

.

Fully loosen the one captive blade screw (2).

Fully loosen the two captive blade holder screws (1).

Remove the blade holder.

Figure 9.20

1

2

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)

Change/Clean Air Filters

Replace CTS Blade/Wick (1-Blade Thick CTS Option)

Refer to Figure 9.21

. Replace the Cap Piercer blade and its CTS Auto-Gloss wick approximately every

two months. If the system runs >500 samples per day, replace the blade and wick more frequently.

The blade count records the number of caps pierced by the blade. Refer to

CHAPTER 10, System

Status and Commands

.

CAUTION

The Cap Piercer blade is very sharp and has been exposed to potentially biohazardous fluids. To prevent injury or exposure, do not touch the points of the blade and wear gloves.

Figure 9.21 Cap Piercer Blade with CTS Auto-Gloss Wick

1

2

4

5

3

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

Figure 9.23

.

Fully loosen the one captive blade screw (2).

Push down on this screw until the blade (3) separates from the blade holder (4).

Fully loosen the two captive blade holder screws (1).

Remove the blade holder (4)

Unclip the wick clip (5).

Figure 9.23

2

1

4

3

5

A015940P.EPS

9-38

A13914AF

A13914AF

Maintenance

Two-Month Maintenance

9

5

Refer to Figure 9.24

.

Remove the blade and wick assemblies as follows:

Hold the blade (1) at the top. Do not touch the points (2) of the blade.

Lift up the blade and remove it with the wick assembly at the same time:

The wick assembly (3) should be attached to the blade.

Do not touch the wick because it contains CTS Auto-Gloss lubricant which is very slippery and difficult to clean.

Discard the old assemblies into a biohazard sharps container.

Figure 9.24

3

1

2

A011872P.EPS

6

Refer to Figure 9.24

.

NOTE

A new blade is shipped with a wick attached. The points of the blade are very sharp. The blade shaft is not sharp.

Remove a new blade and wick from its container.

Hold it at the top of the blade (1), immediately under the blade clamp as shown in

Figure 9.24

.

9-39

Maintenance

Two-Month Maintenance

7

Refer to

Figure 9.25

.

Hold the blade holder (5) with the blade clamp hole (3) on the top as shown. Note that the blade clamp hole (3) is keyed and the blade clamp (2) has a slot. Install the blade (1) into the blade holder (5) as follows:

Put the blade clamp end (2) of the blade into the blade clamp hole (3).

Rotate the blade, if necessary, until it falls into place.

Finger tighten the captive blade screw (4).

Remove the protection from the points (6) of the blade.

Do not touch the points of the blade.

Figure 9.25

6

1

2

3

5

4

A015941P.EPS

8

Refer to

Figure 9.23

.

Carefully move the points of the blade down through the wash tower and through the alignment slot at the bottom:

Push down on the blade holder screws (1) and align them over their holes.

Slowly lower the blade through the alignment slot until the blade holder screws are in their holes. Be careful not to hit the points of the blade on the edge of the metal alignment slot.

The blade is through the alignment slot when the blade holder touches the surface of the frame of the cap piercer.

Secure wick clip to blade holder wash block.

Install and tighten the two captive blade holder screws (1). Tighten the captive blade screw

(2).

9-40

A13914AF

Maintenance

Two-Month Maintenance

9

9

Refer to Figure 9.22

.

Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws (1).

10

Select

OK

.

The system sets the blade count to zero.

The Cap Piercer carriage moves up to Home position.

The system primes the wick with CTS Auto-Gloss lubricant.

Change/Clean Air Filters

IMPORTANT

To minimize system down time, it is recommended to keep on hand a clean set of air filters.

Dirty filters can then be cleaned at a convenient time.

1

Open all lower compartment doors (left, middle and right).

2

Pull up and remove each of the compartment air filters. There are two different sizes of air filters. They are located over vent areas on the inner side of each door.

3

Vacuum or brush each filter thoroughly to remove dust. If excessively dirty, rinse with deionized water. Vigorously shake residual water from filters. Allow the filter to air dry completely.

CAUTION

Do not place a damp filter back on the system. Residual moisture may cause damage to the system. You may find it helpful to order a second set of filters to use as an alternate. The DxC 600 requires two of PN A08879 and one each of PN

A08851 and 466357. The DxC 800 requires three of PN A08879 and one of PN

466375.

A13914AF

9-41

Maintenance

Two-Month Maintenance

4

Lower the clean, dry filters back into position on each door, placing the small filters (1) on top and the large filter (2) on the bottom. Refer to

Figure 9.26

.

Slide each filter into position so that the metal grating faces towards the inside of the instrument when the doors are closed.

Figure 9.26

5

Close all compartment doors.

9-42

A13914AF

Maintenance

Three-Month Maintenance

9

Three-Month Maintenance

Replace Syringe Plungers

Replace Syringe Plungers

The one reagent and two sample syringe plunger rod assemblies should be replaced every three months or when signs of wear (discoloration, flaking tips, etc.) are noticed.

The Syringe Plunger replacement procedures apply to the CC Reagent Syringe, the MC Sample

Syringe, and the CC Sample Syringe.

CAUTION

To prevent damage due to electrical static discharge (ESD), wear a wrist ground strap when you perform this procedure. For further instructions, refer to

Basic

Laboratory Practice

in the beginning of this chapter.

Figure 9.27 CC Reagent Syringe (500 μL)

A015942P.EPS

A13914AF

9-43

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

Figure 9.28

.

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

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)

Figure 9.32

, remove the stir bars from all cups (not necessary for Glucose if the stir bar was previously cleaned during maintenance). Clean the cups with cotton swabs moistened with deionized water. Be sure to moisten the swabs before inserting them into the cups.

9-50

A13914AF

Maintenance

Four-Month Maintenance

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 Glucose Sensor

Replace Calcium and Potassium Electrode Tip

The following procedures apply to the preparation and replacement of calcium and potassium electrodes that are housed in the flow cell. The operator may replace one or both electrode tips at the same time. Replace the calcium tip at 6 months or 80,000 samples.

Before you install a calcium or potassium electrode tip into the flow cell, record the electrode number found on the tip. You must enter this number into the Electronic Maintenance Log at the end of the procedure.

1

Pour ISE Reference Solution (do not dilute) into a clean container to a depth not to exceed two inches (50 mm).

2

Refer to

Figure 9.33

. Unpack a new potassium electrode tip (1) (PN 669117) and/or a new calcium electrode tip (2) (PN 467769).

Unpack each tip and carefully remove the knurled protective cap (3) from membrane end of tip assembly.

Verify that the black protective cover on the internal threaded connector end of the tip assembly is in place.

9-52

A13914AF

A13914AF

Maintenance

Six-Month Maintenance

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

ISE Service

in this section.

9-53

Maintenance

Six-Month Maintenance

ISE Service

The ISE service procedure prevents reagent leakage from the flow cell whenever electrode removal is required.

1

Loosen the two Phillips screws (1) on the ISE module cover and remove the cover.

Figure 9.34

2

Release the locking pin (1) on the ISE module and lift the module until it clicks into a raised, locked position. The locking pin is located on the left side of the ISE module on DxC 800 Systems as shown below. The locking pin is located on the right side of the ISE module on DxC 600

Systems.

Figure 9.35

9-54

A13914AF

A13914AF

Maintenance

Six-Month Maintenance

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 (

As-Needed/As-

Required Maintenance

).

Chloride Electrode (or

Replace the Chloride Electrode Tip

)

CO

2

Measuring Electrode (

Replace the CO2 Membrane )

Sodium Electrode (

Replace the Sodium Measure/Reference Electrode

).

Removal and Installation of the Electrodes

CAUTION

To prevent damage due to electrical static discharge (ESD), wear the wrist ground strap when you perform this procedure. For further instructions, refer to

Basic

Laboratory Practice

in the beginning of this chapter.

1

Disconnect the electrode cable from potassium connector (1) and calcium connector (2).

Figure 9.36

9-55

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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Maintenance

Six-Month Maintenance

12

When system has completed priming, select

Close

to exit the procedure.

CAUTION

Pinch hazard. Keep fingers clear of the ISE module as you lower it.

13

Lower the ISE module by releasing the locking pin. Be careful not to pinch tubing as the ISE module is lowered.

14

Reinstall the ISE module cover.

15

Calibrate all the ISE chemistries. If the calcium electrode tip was replaced, proceed to Step 16.

IMPORTANT

Reference drift for the new electrodes may be observed during the first 4-6 hours after electrode replacement. Results will not be compromised. Recalibrating the chemistry during this time period helps stabilize the electrode.

16

Following calcium electrode tip replacement and calibration:

Program and run at least 20 replicates of serum samples for CALC.

Calibrate calcium.

Replace Glucose Sensor

The Synchron AccuSense glucose oxygen sensor requires no assembly. Each sensor has a gasket positioned over the membrane tip. The sensor is discarded after six months usage on an instrument, at which time a new sensor is installed.

Before you install the glucose sensor, record the sensor number found on the sensor. You must enter this number into the Electronic Maintenance Log at the end of the procedure.

On DxC 800 Systems, the BUNm/UREAm module has an extra glucose sensor connector located next to the BUNm/UREAm electrode connector. This extra glucose connector can be used to precondition a new glucose sensor prior to installation.

Preparation Prior to Replacement (DxC 800 Systems)

For DxC 600 Systems, follow Steps 1–5 in the table below. Then proceed to Draining the Reaction Cup for Sensor Maintenance or Replacement.

For DxC 800 Systems, plug the glucose sensor into the empty connector port, (labeled GLU on the

BUNm/UREAm module) 24 hours before glucose sensor installation minimizes sensor drift.

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Maintenance

Six-Month Maintenance

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

9-59

Maintenance

Six-Month Maintenance

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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Maintenance

Six-Month Maintenance

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.

A13914AF

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

Calibrate Lamps and Sensor

in the Monthly Maintenance section of this chapter

As-Needed/As-Required Maintenance

Replace the Chloride Electrode Tip

Replace the Sodium Measure/Reference Electrode

Replace the CO2 Membrane

Clean the EIC Port

Clean the CO2 Alkaline Buffer Lines

Clean the ISE Drain

Flush the Flow Cell (Manual)

Clean the ISE Flow Cell Using Clenz Solution

Flush the Sample and Reagent Probe

Replace the Sample and Reagent Probe

Clean the CC Sample Probe, Reagent Probes and Mixers

Clean the MC Sample Crane and Collar Assembly

Clean the Precipitate in PHOSm (DxC 800 Only)

Inspect the Cuvette Washer Probe

Wash All Cuvettes With System Wash

Wash the CC Reagent Cuvettes with CCWA

Clean the Work Surfaces

Decontaminate the Sample Racks

Decontaminate the Instrument

Replace the CTS Wick

Replace ISE Drain Pump Tube

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9-63

Maintenance

As-Needed/As-Required Maintenance

Introduction

As-Needed/As-Required Maintenance contains miscellaneous maintenance procedures which may be performed on an as-needed basis or procedures that may be performed on a regular basis as preventive service maintenance.

The As-Required Maintenance includes items that are maintained on an interval schedule, and are normally performed as preventive service maintenance. The As-Required procedures are grouped together with As-Needed Maintenance, categorized by subsystem instead of by interval.

Record any As-Needed or As-Required Maintenance on the Instrument Action Log section of 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.

9-64

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Maintenance

As-Needed/As-Required Maintenance

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

Basic

Laboratory Practice

in the beginning of this chapter.

1

Disconnect the electrode cable from the CL connector.

2

Loosen the flow cell retaining screw (1) located at the top of the flow cell. This is a captive screw and cannot be removed from the flow cell. Pull assembly forward and upward to remove.

IMPORTANT

Do not disconnect any of the reagent lines attached to the flow cell. Removal of the flow cell is not necessary for replacing electrodes located on the right side of the flow cell.

Figure 9.43

A13914AF

9-65

Maintenance

As-Needed/As-Required Maintenance

3

Locate the Chloride electrode (1). Remove electrode by turning the electrode retaining nut.

Figure 9.44

A015946P.EPS

4

Remove the retainer nut from the old electrode. Remove the quad-ring (1) from the tip of the old electrode. Inspect the electrode port if the quad-ring is not on the electrode. Discard the quad-ring.

Figure 9.45

9-66

5

Unscrew the old tip from the electrode assembly. Discard the O-ring and the old electrode tip.

6

Install a new O-ring on chloride electrode tip and screw the tip onto electrode body.

7

Completely dry the electrode port with lint-free tissue.

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Maintenance

As-Needed/As-Required Maintenance

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.

9-67

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

Basic

Laboratory Practice

in the beginning of this chapter..

1

Loosen the two Phillips screws on the ISE Module cover and remove the cover.

2

Release the locking pin on the ISE Module and lift the module until it clicks into a raised, locked position.

3

Drain the flow cell.

Select:

Utils

from the menu bar,

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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Maintenance

As-Needed/As-Required Maintenance

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.

9-71

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

.

A13914AF

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

Basic

Laboratory Practice

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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9-73

Maintenance

As-Needed/As-Required Maintenance

3

Prepare for ISE maintenance and disable autoprime.

Select:

Utils

from the menu bar,

2 Maintenance

,

3 ISE Service

,

Continue

.

The flow cell is prepared for maintenance.

4

Disconnect the CO

2

Measuring Electrode cable (1).

Figure 9.52

1

A010980P.EPS

9-74

A13914AF

A13914AF

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

As-Needed/As-Required Maintenance

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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Maintenance

As-Needed/As-Required Maintenance

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

Damper Assembly

under Monthly Maintenance, in this chapter.

CAUTION

Pinch hazard. Keep fingers clear of the ISE module as you lower it.

9

Lower the ISE module by releasing the locking pin. Be careful NOT to pinch tubing as the module is lowered.

10

Reinstall the ISE module cover.

9-79

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

Basic

Laboratory Practice in the beginning of this chapter.

1

Loosen the two Phillips screws on the ISE module cover and remove the cover.

2

Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked position.

3

Prepare ISE for maintenance and disable autoprime.

Select:

Utils

from the menu bar,

2 Maintenance

,

3 ISE Service

.

Select

Continue

to prepare for maintenance.

9-80

* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).

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Maintenance

As-Needed/As-Required Maintenance

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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Maintenance

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

Figure 9.63

.

21

Remove clamps from lines #18, #24, #23, and #26.

22

Reattach the EIC top sections to the drip tray. Align the guide pin on the bottom of the EIC to the hole on the drip tray and press the EIC down onto drip tray. Tighten the Phillips screw on the top of the EIC.

23

Reconnect the solenoid valves at the valve connector.

24

Select

OK

to close the Maintenance pop-up confirmation window.

IMPORTANT

Reagents immediately prime through the flow cell.

25

Select

Close

in the

Result

pop-up window to exit the

ISE Service

screen.

26

Observe EIC, lines and connections to verify that reagents are flowing properly with no leaks.

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

Basic

Laboratory Practice in the beginning of this chapter.

1

Loosen the two Phillips screws from the ISE module cover and remove the cover.

2

Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked position.

3

Disconnect line #33 from the alkaline buffer reagent bottle and place the line in a small container. (The container is used to catch the line drainage while priming).

4

Unscrew and remove the alkaline buffer reagent bottle cap and insert the straw into a container of 10% bleach solution.

* DO NOT use bleach that contains additives (for example, Ultra Bleach Advantage).

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

Basic

Laboratory Practice in the beginning of this chapter.

1

Loosen the two Phillips screws on the ISE module cover and remove the cover.

2

Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked position.

3

Prepare for ISE maintenance and disable autoprime.

Select:

Utils

from the menu bar,

2 Maintenance

,

3 ISE Service

.

Continue

to drain the flow cell and prepare for maintenance.

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

Basic

Laboratory Practice

in the beginning of this chapter.

1

Loosen the two Phillips screws on the ISE module cover and remove the cover.

2

Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked position.

3

Prepare for ISE Maintenance and disable autoprime.

Select:

Utils

from the menu bar,

2 Maintenance

,

3 ISE Service

.

Select

Continue

to drain the flow cell and prepare for maintenance.

4

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

Basic

Laboratory Practice

in the beginning of this chapter.

1

Loosen the two Phillips screws on the ISE module cover and remove the cover.

2

Release the locking pin on the ISE module and lift the module until it clicks into a raised, locked position.

3

Prepare the flow cell for maintenance.

Select:

Utils

from the menu bar,

2 Maintenance

,

3 ISE Service

,

Continue

.

4

Remove line #23 from the bottom of the flow cell (see

Figure 9.72

). (A Luer connector and small

diameter tubing may be found in the Flow Cell Cleaning Kit (PN 473181)). Connect the open end of the tubing to the bottom of the flow cell.

Figure 9.72 ISE Flow Cell

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

Basic

Laboratory Practice

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

Basic

Laboratory Practice

in the beginning of this chapter.

Replace the Old Probe

1

Press the

STOP

button on the instrument to stop all motors.

2

Using a 3/8 inch open end or adjustable wrench, loosen the nut (1) at top of probe.

Figure 9.74

1

A007413P.EPS

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,

Clean

Probes (Exterior) in this chapter.

Clean the Precipitate in PHOSm (DxC 800 Only)

The phosphorus (PHOSm) cup should be cleaned when protein precipitate accumulates at the top of the liquid surface. The precipitate may not clear from the cup upon draining causing noise flags to occur.

1

Using an applicator swab, skim off the visible precipitate floating at the top of the PHOSm cup surface.

2

Drain the PHOSm cup.

Select:

Utils

from the menu bar,

2 Maintenance

,

4 Cup Maintenance

,

Phosphorus

button,

Drain

.

The cup drains in preparation for maintenance.

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

9-106

A13914AF

A13914AF

Maintenance

As-Needed/As-Required Maintenance

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.

9-107

Maintenance

As-Needed/As-Required Maintenance

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.

9-108

A13914AF

Maintenance

As-Needed/As-Required Maintenance

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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Maintenance

As-Needed/As-Required Maintenance

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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Maintenance

As-Needed/As-Required Maintenance

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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Maintenance

As-Needed/As-Required Maintenance

Wipe the touchscreen with 70% isopropanol, water, or any commercial computer screen cleaner.

Decontaminate the Sample Racks

1

Prepare a 10% bleach

*

solution (one part 5.25% sodium hypochlorite (PN A32319), nine parts deionized water). Use within 24 hrs.

2

Using a large container or sink, immerse all sample racks in the bleach solution.

3

Allow the sample racks to soak at room temperature in the 10% bleach solution for 15–20 minutes.

4

Remove the racks, rinse with deionized water or tap water, and allow to dry.

IMPORTANT

Repeated decontamination of racks may result in rack label damage. If the label starts to bubble or peel, remove and replace with a new label.

Decontaminate the Instrument

This procedure provides instructions for cleaning and decontaminating system tubing, waste sumps, and reservoirs. Perform this procedure when microbial contamination is either evident or suspected. This procedure should take about 1.5–2.0 hours.

CAUTION

All biohazard precautions should be observed when doing maintenance, service, or troubleshooting on the system. This includes but may not be limited to wearing gloves and eye shields, and washing hands after working on contaminated portions of the system.

Materials Required:

10% bleach solution (one part 5.25% sodium hypochlorite (PN A32319), combined with nine parts deionized water) - 8 Liters

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Maintenance

As-Needed/As-Required Maintenance

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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Maintenance

As-Needed/As-Required Maintenance

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

As-Needed/As-Required Maintenance

Replace the CTS Wick

This procedure applies to the UniCel DxC 600/800 and the UniCel DxC 600i Systems with the Closed

Tube Sampling (CTS), 1-Blade Thick Option. The wick is found within the Cap Piercer Assembly.

The Cap Piercer wick and blade are normally replaced every two months during scheduled maintenance. However, if blood is not continuously wiped from the sample tube caps before they are loaded onto the instrument, the CTS blade/wick area becomes dirty. This may cause a contaminated condition. As a result, use this procedure to replace the wick as needed.

CAUTION

All biohazard precautions should be observed when doing maintenance, service, or troubleshooting activities on the system. This includes but may not be limited to wearing gloves and eye shields, and washing hands after working on contaminated portions of the system.

Materials Required:

1 medium flat-edge screwdriver

1 medium Phillips screwdriver (for DxC 600i systems)

1 small tweezers

2 plastic trays (approximately 9 inches × 12 inches) (23.9 centimeters × 30.5 centimeters)

Absorbant paper towel

1 bottle of Auto-Gloss

1 Wick Kit (PN A26924)

Cotton-tip applicators (6 inches [15.2 centimeters] long, or greater)

Disposable pipettes

Personal protective gear such as rubber gloves and eye shields

Scissors

System Preparation

The Cap Piercer Blade must be lowered before the Wick is replaced. Perform the following procedure:

1

Select

Utils

from the menu bar.

2

Select

2 Maintenance

.

3

Select

1 CTS Blade Replacement.

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Maintenance

As-Needed/As-Required Maintenance

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

Figure 9.81

and perform the following procedure:

1

Lift the instrument cover.

2

Use a flat-edge screwdriver to fully loosen the two screws (1) from Cap Piercer Cover (2).

Figure 9.81

2

1

A007556P.EPS

3

Lift and remove the Cap Piercer Cover and set it aside.

9-117

Maintenance

As-Needed/As-Required Maintenance

Remove the Blade Assembly and Wick Clip Assembly

The Cap Piercer Assembly is now visible as shown in

Figure 9.82

. Remove the Blade Assembly and

Wick Clip Assembly as follows:

1

Refer to Figure 9.82

. Use a flat-head screwdriver to loosen the two Blade Holder Screws (1) from

Blade Holder (2).

CAUTION

The points of the Blade (3) are very sharp and extend below the Wash

Tower (4). To prevent possible injury or exposure, avoid the bottom of the Wash

Tower.

Figure 9.82

1

2

4

3

A007557P.EPS

9-118

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Maintenance

As-Needed/As-Required Maintenance

9

2

Refer to Figure 9.83

. Lift the Blade Assembly (1) straight up as shown.

NOTE

The Blade Holder Assembly includes the Blade Holder and the Blade.

CAUTION

The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids. To prevent possible injury or exposure, avoid the Blade area.

Figure 9.83

1

A007558P.EPS

3

Put the Blade Assembly onto a plastic tray. DO NOT touch the Blade.

9-119

Maintenance

As-Needed/As-Required Maintenance

4

Remove the old Wick Clip Assembly (1) from Wash Tower (2) by lifting up on both sides of Wick

Clip as shown in

Figure 9.84

. Make sure that the old Wick is retained within the Wick Clip. If the

wick is NOT in the Wick Clip, the Wick should be found within the Wash Tower area. In this case, use tweezers to remove the Wick. Put the old Wick and Wick Clip into a biohazard waste container.

CAUTION

Observe all laboratory practices or procedures that pertain to handling of infectious and pathogenic materials.

Figure 9.84

3

1

1

2

A007559P.EPS

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Maintenance

As-Needed/As-Required Maintenance

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

Refer to Figure 9.85

. Rinse the Blade with hot water as shown.

CAUTION

The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids. To prevent possible injury or exposure, avoid the Blade area.

Figure 9.85

A007560P.EPS

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Maintenance

As-Needed/As-Required Maintenance

2

Refer to

Figure 9.86

. Wipe the Blade with a cotton-tip applicator as shown.

CAUTION

The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids. To prevent possible injury or exposure, avoid the Blade area.

Figure 9.86

3

Put the Blade Assembly back on the same tray.

A007561P.EPS

9-122

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Maintenance

As-Needed/As-Required Maintenance

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

9-123

Maintenance

As-Needed/As-Required Maintenance

Install the Wick Clip Assembly and Blade Assembly

1

Install Wick Clip Assembly (1) onto Wash Tower (2). Make sure both ends of the Wick Clip are

secured. Refer to Figure 9.84

.

2

Carefully pick up the Blade Assembly and orient end points of Blade with Slots (3) on Wick Clip.

Slowly push the Blade Assembly straight down so that the Blade goes through the Wick, through the Wash Tower, and through the alignment slot at the bottom. Refer to

Figure 9.84

.

CAUTION

The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids. To prevent possible injury or exposure, avoid the Blade area.

3

Lift up the Blade Assembly again as shown in Figure 9.83

. Put the Blade Assembly back on the

plastic tray.

4

Remove the Wick Clip Assembly again as shown in Figure 9.84

. Examine the bottom of Wick area for any loose fibers. Remove any loose fibers with scissors.

NOTE

Loose fibers clog the drain.

5

Repeat Steps 1 and 2 above.

6

Align Blade Holder (2) to screw holes. Install and tighten the two Blade Holder Screws (1) with a screwdriver. Refer to

Figure 9.82

.

7

Install the Cap Piercer Cover (2). Tighten the two cover Screws (1) with a screwdriver. Refer to

Figure 9.81

.

8

After the Cap Piercer Cover is installed, select

Cancel

on the screen to retain the blade count since the Blade was not replaced. If

OK

is selected, the system resets the blade count to zero.

9

Select

Exit F10

to exit the

Maintenance

screen.

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Maintenance

As-Needed/As-Required Maintenance

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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9-125

Maintenance

As-Needed/As-Required Maintenance

2

Open the left door on the DxC. The ISE drain pump is located on the inside left wall.

CAUTION

BIOHAZARDOUS MATERIALS HAZARD. Observe all biohazard precautions when you perform maintenance, service, or troubleshoot the system. This includes, but may not be limited to, wearing gloves and eye shields and washing hands after working on contaminated portions of the system.

MOVING PARTS HAZARD. Do not place hands near any moving parts while the system is operating.

3

Refer to

Figure 9.88

.

Lower the clear plastic cover (1).

Disconnect both pump tube fittings (2 and 3), and move the tube out of both pinch clamps

(4 and 5).

Manually rotate the pump roller mechanism (6) approiximately half a turn while removing the tube. Use caution as the tube may contain residual fluid.

Figure 9.88 ISE Drain Pump

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

As-Needed/As-Required Maintenance

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.

9-127

Maintenance

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

CHAPTER 9,

Maintenance

.

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

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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

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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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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

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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

.

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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

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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.

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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.

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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.

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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.

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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.

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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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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.

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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

)

.

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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.

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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.

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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

.

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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

CHAPTER 9, Maintenance

in this manual for maintenance instructions.

Event Log

Introduction

The Event Log is a record of events and errors that are logged (for example, CAU: DI Water Canister

Level Low. Message ID 0x01FA000E.). This logged information can be used as a troubleshooting tool if a problem is encountered while operating the instrument.

The entire Event Log can be viewed, printed, or copied to disk. It is possible to select only a portion of the Event Log to work with by specifying classes and/or a date and time range.

11-6

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Utilities

Event Log

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

)

.

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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

Print

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

Print

. This will print the entire selection, not just the page currently shown.

11-8

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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.

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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

Print

. This will print the entire selection, not just the page currently shown.

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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

Print

from the

Event Log

dialog box.

OR

Select

Print

from the

Display Events

dialog box.

To stop the printer,

Select

Instr Cmd

from the menu bar,

Select

3 Stop Print

.

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

10% bleach solution, 9-80 ,

9-83 ,

9-84 ,

9-86

, 9-112

1-Blade CTS option

See Cap piercer

1-Blade Narrow CTS,

2-5

1-Blade Thick CTS, 2-5

70% isopropyl alcohol,

9-14 ,

9-27

, 9-31 ,

9-80

A

Absorbance versus time, 7-8

AccuSense glucose sensor

Connector port, 9-59

Drain reaction cup for sensor, 9-58 ,

9-60

Gasket, 9-59 ,

9-61

Prepare prior to replacement, 9-60

Replace, six-month,

9-48

,

9-60

, 9-62

Stir bar and cup, clean, 9-62

Air filters

Change, 9-41

Clean, 9-41

Alarm/Annunciator

See Status Alarm/Annunciator

Alignment

See UniCel DxC Synchron Clinical Systems

Reference Manual

Alkaline buffer damper assembly

Adjust fluid level,

9-20

Fluid level high,

9-22

Fluid level low,

9-21

Check fluid level, 9-23

Replace alkaline buffer reagent, 9-18

Archive QC Data,

5-23

Auto ORDAC,

3-4

Auto serum index,

3-4

Autoloader,

1-9

B

Backup,

11-13

Alignment data,

11-13 ,

11-16

System parameters, 10-2 ,

11-13

Bar code reader, 1-19

Hand-held (MC),

1-13

Reagent, CC, 1-19

Sample,

1-10

Bar codes, QC, 5-7

Printing, 5-7

Beer's Law, 1-54

Boot

Full boot,

10-14

Buttons,

1-xxxiv

C

Calibration

Acceptance limits,

4-27

Bypass,

4-25

Calibrator set point modifications, 4-28

Enzyme validator,

4-23

Error detection, 1-53

Extending calibration time, 4-26

Failure messages,

4-18

Formulas

Endpoint and first-order, 1-44 –

1-49

Non-linear, 1-50

, 1-51

Override, 4-24

Reprint calibration report,

4-31

Request

Canceling a calibration request, 4-18

Slope offset adjustment, 4-29

Status,

4-14

Within-lot calibration,

4-19

Designations, 4-22

Enabling within-lot calibration, 4-19

Index-1

Index

Index-2

Frequency,

4-19

Limitations, 4-22

Cap piercer

1-Blade CTS option

CTS Auto-Gloss

1-Blade Narrow CTS,

1-11

1-Blade Narrow CTS option, 9-32

1-Blade Thick CTS, 1-11

1-Blade Thick CTS option,

9-32

See CTS

Carousel,

1-6

Cartridge chemistries (CC),

1-43

Calibration theory, 1-43 –

1-53

Spectrophotometric methods,

1-54

Cartridges, 1-19

Reagent, 1-19

CC — Cartridge chemistry,

9-2

CC reagent mixer, clean,

9-31

CC sample mixer, clean,

9-31

CC sample probe, reagent probes and mixers

Automated cartridge chemistry probe cleaning

Load CCWA, 9-103

CCWA — Cartridge chemistry wash solution,

9-2

Chemistry parameters,

8-4

Chemistry print name, defining, 3-6

Chemistry, configuring,

3-5

Clearing chemistries,

3-6

Deleting a chemistry, 3-6

Inserting a chemistry, 3-6

Chloride Electrode tip, Replace,

9-64

Closed Tube Sampling

See CTS

CO

2

alkaline buffer reagent straw and line, bleaching

Line #33, 9-86

CO

2

measuring electrode membrane, 9-73

Broken, 9-78

ISE service, 9-74

Remove, 9-74

Replace,

9-76

Wrinkled,

9-78

Configuration, system, 3-31

Constituent code,

5-6

, 5-11

Control,

5-9

5-14

Bar codes,

5-7

Constituent code,

5-6 ,

5-11

Definition,

5-4

Deleting,

5-13

Editing, 5-9

Fields,

5-6 ,

5-11

File number,

5-6

, 5-11

Printing,

5-13

QC chart,

5-17

QC file list,

5-14

QC summary,

5-15

Reviewing, 5-12

Copy to disk feature, 5-21

Creatinine clearance results

Calculation, 3-23

Critical ranges, 3-19

Critical Result Rerun,

3-15

Critical result rerun, 7-6

CTS — Closed Tube Sampling,

9-2

CTS (Closed Tube Sampling)

1-Blade Narrow CTS option,

1-11

1-Blade Thick CTS option,

1-11 ,

2-5

Blade count,

10-3

CTS Auto-Gloss, 2-v ,

11-2

CTS Count,

10-3

CTS Tracking, 2-x

, 10-7

4-Blade Foil CTS option, 2-5

CTS Auto-Gloss,

9-10

CUPs lamp and sensor calibration, 9-29

, 9-30

Cuvette reaction system,

1-21

Cuvette washer probe, inspect

Blocked probe,

9-107

Cuvette washing

Wash station, 1-23

Cuvette water blank status, 10-6

Cuvette wiper

Reinstall,

9-12

Replace, 9-10

Cuvettes

Automated wash all cuvettes, 9-109

D

Data storage, 7-1

Results, 7-1

Sample programs,

7-1

Database version, 3-23

Date/time setup,

3-13

Deleted results,

11-7

Deleting,

5-19

Control,

5-12

Critical result rerun,

7-6

QC data point,

5-20

Demographics, 3-14

Index

Dilution factor, 6-10

Drain assembly, 1-26

Drugs of abuse testing (DAT),

1-53

E

Editing

Control, 5-9

EIC, 9-80

EIC — Electrolyte injection cup, 9-2

EIC ports, flushing, 9-80

9-86

ISE service,

9-80

Electrolyte injection cup (EIC), 1-15

Electrostatic Discharge, 9-1

Enable/disable modules, 10-16

,

10-17

Enzyme validator,

4-23

Enzyme verification,

1-53

Error detection

See Calibration

Error detection limits,

8-13

Event log, 11-6

Exit check criteria,

8-17

,

8-18

Expanded user defined chemistry feature,

8-20

Extinction coefficients,

8-16

ICS/smart module status, 10-5

Immediate reporting,

3-14

Instrument commands,

10-8

Intended use,

1-xxxiii

ISE — Ion selective electrode (flow cell

module), 9-2

ISE drain cleaning, six-month

Drain top,

9-89

Drip screen,

9-89

ISE service, 9-88 ,

9-91

ISE module, 1-13

ISE reference solution,

9-52

ISE service, 9-54

, 9-64

K

Keyboard,

3-29

L

Labels,

2-xv –

2-xxiii

, ??– 2-xxiv

Language/keyboard, selection, 3-29

Levey-Jennings,

5-16

Log fields,

1-40

, 1-41

LPIA (large particle immuno assay)

module, 1-21 ,

1-22

, 8-1 ,

8-6 ,

10-6

I

F

Failure messages, calibration,

4-18

File number,

5-6 ,

5-11

Flow cell (ISE), 1-16

Flow cell flush kit,

9-91

Flow cell tubing #23, 9-92

Flow cell tubing #27, 9-92

Flow cell tubing #35, 9-92

Flow cell, flushing

ISE service,

9-91

9-94

H

Hazards, 2-v

Home,

10-8

Host specifications

See Host Interface Specifications Manual (P/

N A16150)

Hydropneumatic system,

1-24

Status, 10-5

Icons,

1-xxxiv

M

Main screen, 1-27 –

1-42

Post run summary, 1-39 ,

1-42

Pre run summary, 1-39 ,

1-42

Results recall, 1-38

,

1-39

Sample unload, 1-39

Main screen and program structure,

1-27

Maintenance,

9-1 ,

11-6

Manual

Conventions,

1-xxxiii

How to use, 1-xxxv

Scope,

1-xxxiii

Manual assignments,

6-7

Math models, 1-50 ,

1-51 ,

8-6

MC — Modular chemistry,

9-2

MC components, reassemble,

9-30

Mixer wash cup, 1-20

Reagent, 1-20

Modem,

11-12

Modular chemistries (MC),

1-53

Basic components,

1-17

Modular reagents

Index-3

Index

Index-4

Check levels,

9-10

Modules,

1-17

Modules, enable/disable,

10-16

N

No Foam, 9-10

O

Offload track, 1-9

On/off switch, 10-13

ORDAC,

6-10

Auto ORDAC,

3-4

Manual, 6-10

P

Panels,

3-15

Patient results

Critical results rerun,

3-14

, 3-19 ,

7-6

Pause, 10-9

PHOSm, cleaning precipitate

Protein precipitate,

9-105

Photometer assembly,

8-6

Post run summary,

1-39

, 1-42

Potassium and calcium electrode tips

Replacing, six-month

ISE service,

9-54

Removing/installing,

9-52 –

9-58

Power Subsystem Status,

10-4

Pre run summary,

1-39

,

1-42

Precautions,

2-viii

2-xiv ,

5-9

Prime,

11-1

Printers,

3-30

Printing,

5-13

, 7-7

Control,

5-13

Data,

1-38

QC chart,

5-17

QC file list, 5-14

Recalled results, 7-7

Priority

Position,

1-9

Priority load,

1-9

Probes, clean,

9-14

Processing parameters, 8-8

Programming samples, 6-1

Batch,

6-11

Dilution factor, 6-10

Manual, 6-10

Manual assignments,

6-7

ORDAC,

6-10

Rack status, 6-3

Rack/cup position,

6-4

Sample ID,

6-4

Sample status,

6-4

Pushers,

1-10

Q

QAP Disk,

5-21

Quad-ring

BUNm/UREAm electrode, 9-27

CO

2

measuring electrode,

9-75

Potassium and calcium electrode,

9-56

,

9-66

Quality Assurance Program (QAP)

Copy to disk feature,

5-21

Quality control (QC),

5-1 –

5-25

Chart, 5-16

Printing QC bar code assignments,

5-7

QC action log, 5-20

QC chart,

5-16

QC file list,

5-14

Displaying,

5-14

QC log, 5-18

Summary, 5-15

R

Racks, 1-7

Sample, 1-7

Sizes, 1-7

Status,

6-3

Ratio pump, 1-14

Reaction carousel, 1-21

Cuvettes, 1-21

Reaction type,

8-4

Reagent carousel, 1-19

Reagent cartridges, 1-18

Reagent handling system, CC, 1-17

Reagent parameters,

4-10

Loading,

4-11

Reagent status

Sorting reagent status

Days left,

4-3

Tests left,

4-3

Reagent syringe,

9-43

See also Sample and reagent syringes,

replacing three-month

Recalling results

Index

Displaying, 7-5

On-board samples, 1-38

Patient ID, 7-4

Printing,

7-7

Rack and position, 7-3

Run date/time, 7-4

Sample ID, 7-2

Replicates,

3-16

Reportable range, 3-17

Reports,

3-16

Statistical summary, 7-10

Reserved racks, assigning,

2-xiii

Reset,

10-12

Restore,

11-13

Results, 1-39

Results recall, 1-38

,

7-1

Main screen, 1-38

Retainer nut,

9-26 ,

9-56

, 9-61 ,

9-66

Review, 5-24

Review results,

1-41

Reviewing,

5-12

S

Sample

Carousel, 1-12

Gate, 1-10

Handling system,

1-6

ID, 6-5

Log, 1-39 –

1-41

Programming

See Programming samples

Racks, 1-7

, 2-2

Replicates, 3-16

Type

Default,

3-13

Sample and reagent syringes, replacing threemonth

Checking for bubbles, 9-47

Plunger rods,

9-44

Syringe rod replacement, 9-44

Sample syringe,

9-43

CC sample syringe, 9-44

MC sample syringe,

9-44

Serum index

Auto ORDAC, 3-4

Serum Index result, 3-15

Service

Monitor, 3-27

See also Metering Manual (P/N 967259)

Setup,

3-30

Setup

Screens,

3-1

Shutdown, 10-12

Shuttle, 1-10

Silicone compound,

9-28

Smart modules

Status,

10-5

Sodium Azide preservative,

2-vii

Software version,

3-23

Special calculations, 3-20

Specifications, system

Clearances, 1-2

Elevation, 1-3

Operating temperature, 1-3

STAT, 3-14

Statistical summary report,

7-10

Status

Alarm/Annunciator,

3-32

See also System status,

10-1

Status-cycle count,

10-2

Stop print,

10-11

Surfaces and covers, cleaning,

9-111

Symbols, 2-xv –

2-xxiii , ??–

2-xxiv

System configuration, 3-31

System description, 1-1

System hazards

Moving parts,

2-vi

System Status,

10-1

T

Tables,

3-10

Beckman Coulter defined chemistries,

3-10

Predefined special calculations,

3-21

Predefined special formulas,

3-21

Temperatures, 10-2

Timed urine results

Constants and factors,

3-23

Total protein cup maintenance,

9-13

Touch Screen Calibration,

11-16

U

Unload all, 10-18

Unloading samples, 1-39

Update,

3-31

See Version upgrade

UPS (Uninterruptible Power Supply),

10-13

User,

8-3

Index-5

Index

User defined reagents

Configuring, 3-5

Defining,

8-3

– 8-19

Deleting,

3-6

Inserting,

3-6

Minimum operating requirements,

8-1

Removing,

8-19

Setup,

3-24

, 8-3

V

Valid entries, 6-5

Version information,

3-23

Version upgrade,

3-31

W

Warnings, reagent and calibration status,

4-15

Wash Concentrate II,

9-10

Waste B, pause/resume,

10-15

Wavelength

Primary,

8-6 ,

8-15

Secondary,

8-6

, 8-15

Westgard rules,

5-2 ,

5-3

Wheel

See Carousel

Wrist ground strap, 9-43

Index-6

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

, iii

Safety Notice

, v

Introduction

, xxxiii

CHAPTER 1:

System Description

, 1-1

System Description

, 1-1

Operational Conditions

, 1-1

System Components

, 1-5

Sample Handling System , 1-6

Modular Chemistry (MC) System , 1-12

Cartridge Chemistry (CC) Reagent Handling System , 1-17

Cuvette Reaction System

, 1-21

Hydropneumatic System , 1-24

Operation and Control Components

, 1-26

Main Screen and Program Structure , 1-27

Theory of Operation

, 1-43

Cartridge Chemistry: Calibration Theory , 1-43

Modular Chemistry: Calibration Theory , 1-53

Cartridge Chemistry: Principles of Measurement , 1-54

CHAPTER 2:

Preparing Samples for Analysis

, 2-1

Routine Operation Overview , 2-1

Preparing Samples for Analysis

, 2-2

How to Use Reserved Racks , 2-7

xxvii

Contents

CHAPTER 3:

System Setup Options

, 3-1

Overview , 3-1

Password Setup , 3-2

Auto Serum Index/ORDAC , 3-4

Configuring the Chemistry Menu , 3-5

Setting the Default Sample Type , 3-13

Date/Time Setup , 3-13

Demographics Setup , 3-14

Patient Results – Immediate Reporting Setup

, 3-14

Panels

, 3-15

Replicates

, 3-16

Report Setup , 3-16

Reportable Ranges Setup

, 3-17

Reference/Critical Ranges Setup , 3-19

Sample Comments Setup

, 3-19

Special Calculations Definition , 3-20

Timed Urine and Creatinine Clearance Results

, 3-23

Version Information , 3-23

Units/Precision Setup , 3-24

User Defined Chemistries Setup

, 3-24

Bar Code Setup

, 3-25

Maximum Sample Program Age , 3-26

Reserved Racks/Obstruct Detect

, 3-26

Disable Service Monitor , 3-27

Host Communications

, 3-28

Language/Keyboard Setup , 3-29

Printer Setup

, 3-30

Service Setup

, 3-30

System Configuration , 3-31

Version Upgrade

, 3-31

Status Alarm/Annunciator , 3-32

Chemistry Update , 3-32

Auto Generation of Control

, 3-33 xxviii

CHAPTER 4:

Reagent Load/Calibration

, 4-1

Reagent Load , 4-1

System Calibration

, 4-12

Load a Calibrator Diskette , 4-12

Calibrator Assignment

, 4-13

Calibration Status , 4-14

Reagent and Calibration Status Warnings , 4-15

Request a Calibration , 4-16

Calibration Failure Messages

, 4-18

Within-Lot Calibration , 4-19

Enzyme Validator , 4-23

Calibration Override , 4-24

Chemistry Bypass , 4-25

Extend Calibration Time

, 4-26

Calibration Acceptance Limits , 4-27

Calibrator Set Point Modifications , 4-28

Slope Offset Adjustment

, 4-29

Reprint Calibration Reports , 4-31

CHAPTER 5:

Quality Control

, 5-1

Quality Control

, 5-1

Define a Control , 5-4

Control ID Assignments

, 5-7

Run Control Samples

, 5-7

Edit a Control Definition

, 5-9

Review a Control Definition , 5-12

Delete a Control

, 5-12

Print QC Ranges , 5-13

QC File List , 5-14

QC Summary , 5-15

QC Chart (Levey-Jennings)

, 5-16

QC Log

, 5-18

Quality Assurance Program (QAP) “Copy To Disk” Feature , 5-21

Archive QC

, 5-23

Contents

xxix

Contents

Review Archived Data

, 5-24

CHAPTER 6:

Sample Programming and Processing

, 6-1

Overview , 6-1

Prior to Programming

, 6-2

Identify Samples , 6-4

Sample Programming and Processing

, 6-6

Additional Programming Information , 6-10

Clear Samples , 6-12

CHAPTER 7:

Results Recall

, 7-1

Overview , 7-1

Recall Results by Sample ID , 7-2

Recall Results by Rack and Position

, 7-3

Recall Results by Patient ID

, 7-4

Recall Results by Run Date/Time

, 7-4

Display Recalled Results , 7-5

Edit Critical Rerun Result , 7-6

Print Recalled Results

, 7-7

Send Results to the Host

, 7-8

Absorbance Versus Time , 7-8

Statistical Summary Report

, 7-10

CHAPTER 8:

User Defined Reagents

, 8-1

Overview , 8-1

Requirements and Precautions , 8-1

User-Defined Reagent Setup

, 8-3

Chemistry Parameters , 8-4

Processing Parameters

, 8-8

Error Detection Limits , 8-13

Wavelength Selection

, 8-15

Determination of Extinction Coefficients

, 8-16

Exit Check Criteria

, 8-17

User Defined Reagent Removal

, 8-19

Expanded User Defined Chemistry Feature

, 8-20 xxx

Contents

CHAPTER 9:

Maintenance

, 9-1

Overview , 9-1

Electronic Maintenance Log , 9-4

Twice Weekly Maintenance

, 9-7

Weekly Maintenance , 9-9

Check Chloride Calibration Span , 9-18

Monthly Maintenance , 9-19

Two-Month Maintenance , 9-38

Three-Month Maintenance

, 9-45

Four-Month Maintenance , 9-50

Six-Month Maintenance , 9-54

As-Needed/As-Required Maintenance

, 9-66

CHAPTER 10:

System Status and Commands

, 10-1

Overview , 10-1

System Status

, 10-1

Status-Cycle Count

, 10-2

Temperatures

, 10-3

Show Temperature Status

, 10-3

Power Subsystems

, 10-4

Hydropneumatics Subsystem , 10-4

ICS/Smart Modules , 10-5

Cuvette Water Blank Status

, 10-6

CTS Tracking

, 10-7

Instrument Commands

, 10-8

Home

, 10-8

Pause

, 10-9

Stop Print , 10-11

Shutdown , 10-12

System Power On/Boot , 10-14

Pause/Resume Waste B , 10-15

Enable/Disable Modules , 10-16

Unload All

, 10-18 xxxi

Contents

CHAPTER 11:

Utilities

, 11-1

Overview , 11-1

Prime

, 11-1

Maintenance , 11-6

Event Log , 11-6

Alignment/Diagnostics/PVTs

, 11-12

Metering , 11-12

Modem

, 11-12

Backup/Restore

, 11-13

Touch Screen Calibration

, 11-16

CHAPTER 12:

Troubleshooting Calibration and Result Errors

, 12-1

Calibration Errors

, 12-1

MC Calibration

, 12-2

Linear Calibration

, 12-7

Non-Linear and Multipoint Calibrations , 12-10

Troubleshooting Result Errors , 12-13

Error Codes and Definitions , 12-14

Error Code – Definitions , 12-17

Common Error Messages and Corrective Actions , 12-1

Glossary

, Glossary-1

Index

, Index-1

Related Documents

xxxii

CHAPTER 12

Troubleshooting Calibration and Result Errors

Calibration Errors

Introduction

The following pages contain descriptions of calibration reports for linear, non-linear, electrolyte module, and cup module chemistries and explanations of what each field on the report is used for when calibrating each chemistry type.

Calibration Error Checking

Calibration and Result Error checking is used to flag system and reagent issues. Error checking is performed on the final result and on interim steps of the reaction. The error flags may be directed to a calculated calibration factor or to any of the interim data used to generate a final calibration result. The flags may be indicative of a variety of different hardware, reagent, or sample (calibrator) issues and can be used to troubleshoot different system issues. Any calibrator or sample outside of any one or more calibration limits will be flagged.

Calibration Error Flags

Table 12.1

below is a general list of the calibration errors for linear, multipoint, and MC calibrations.

These errors are listed in the "Failed Calibration Report" area of the calibration report. Descriptions of each of the calibration error flags are listed, in more detail, by calibration type in the following sections.

Table 12.1 Calibration Error and Remarks

Printed Flag

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.

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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

.

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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Sample/Reference Deviation

The Sample and Reference deviation error checks are used as a measure of noise for electrolytes.

Each Sample ADC and each Reference ADC is actually an average of ten readings.

The difference between the high and low values (deviation) of the ten electrode readings (taken milliseconds apart) must be within the maximum deviation.

Maximum deviations are as shown in

Table 12.3

below:

Table 12.3 Maximum Allowable Sample/Reference Deviations by Chemistry

Chemistry Maximum Deviations

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

below defines the Fields

in the order they are shown for each chemistry on a typical ISE Module Calibration Report.

Table 12.4 ISE Module Calibration Report Field Definitions

Field

Sample Reference

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.

12-4

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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

Table 12.5

below defines the Fields in the order they appear for each chemistry on a typical MC

Calibration Report.

Table 12.5 Cup Module Calibration Report Field Definitions

Field Description

Rate

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

Formulas

.

Calibration flags that are specific to the linear photometric chemistries, causing the reagent to fail its calibration, are back-to-back and Calibrator Range (High/Low) errors, and for linear chemistries that use more than one calibrator, Span.

To view the calibration flag limits for all calibrated chemistries, access View Calibrator Acceptance

Limits in the

Rgts/Cal

screen under

Options

. Calibration flags for any chemistry with loaded calibration data are available to view and print.

Back-to-Back

A back-to-back error check is a measure of system precision during calibration.

A back-to-back value is the difference between the two usable replicate values. If the back-toback limit is exceeded the calibration fails.

Limits are either pre-programmed in the system chemistry database or downloaded from disk before calibration.

Calibrator Range (High/Low)

Calibrator Range (High/Low) error check is a measure of reagent performance or accuracy.

Calibrator ADC values are compared to acceptable ranges for calibrator values. Calibration fails if the calibrator ADC values fall outside the acceptable calibrator limits.

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Linear Calibration

Span

Span is a measure of the sensitivity of the reagent and verifies that two consecutive calibrator levels values are a minimum distance apart.

The difference between two consecutive calibrator rates or absorbances must exceed the minimum limit or the reagent fails calibration.

Linear Calibration Report

The calibration report can be a useful tool for identifying issues.

Table 12.6

below defines the fields in the order they appear for each chemistry on a typical Linear Calibration Report.

Table 12.6 CC Linear Calibration Report Field Descriptions

Field

Reagent Identifiers

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.

12-8

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Linear Calibration

12

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

12-9

Troubleshooting Calibration and Result Errors

Non-Linear and Multipoint Calibrations

Non-Linear and Multipoint Calibrations

Overview

Non-linear chemistries include drugs and specific protein assays. The calibration curves for nonlinear calibrations are logarithmic or have other non-linear relationships.

Non-linear chemistry calibrations may have single level or multilevel calibrators.

Multipoint calibrations are based on a single determination of each calibrator level (five or six levels). The standard curve is determined by use of one of several non-linear math models.

Single point non-linear calibrations are based on one or two levels of calibrators. These chemistries set calibration based on two to four replicates of each calibrator level.

Failed Multipoint calibration errors will be noted with an (*) at the bottom of the calibration report.

Refer to CHAPTER 1, System Description, Non-Linear Chemistries

and

Non-Linear Calibration

Formulas for additional information on this subject.

Non-Linear Calibration Checks

Non-linear calibrations have a set of calibration checks specific to non-linear calibrations.

The first check determines whether the data is reasonable to attempt the curve fitting.

The second check determines whether the Multipoint span is within acceptable limits.

The next set of errors are inherent to non-linear curve fitting and may or may not cause calibration failure. Under certain conditions the curve fitting will produce parameters and curves that may contain mathematical errors. Typically these errors occur outside of the reagent dynamic range and have no effect on sample recovery. Math errors may be either overrideable or non-overrideable depending on the severity of the failure. Math errors are reported as "MATH ERROR #" with the number associated with a specific error that has occurred.

Multipoint Span

The Multipoint Span flag is a measure of sensitivity over the entire standard curve.

This is the difference between consecutive calibrator rates or absorbencies. There can be up to six Multipoint spans for Level 0–1, 1–2, 2–3, 3–4, 4–5, 5–0.

Recovery

The Recovery Flag determines whether recovery errors for each calibration level are too large for a calibration to be useful. The difference between the recovered concentration and the actual concentration exceeds specification. This error is overrideable.

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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.

Table 12.7

below provides definitions of specific calibration fields found on those two reports.

Table 12.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions

Field

Reagent Identifiers

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.

12-12

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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

Table 12.8

below.

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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.

Table 12.9

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

A13914AF

12-15

Troubleshooting Calibration and Result Errors

Error Codes and Definitions

Table 12.9 Result Errors and Codes (Continued)

Result Displayed on Report Printed in

Remarks Area

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

12-16

A13914AF

Troubleshooting Calibration and Result Errors

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.

12-17

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

range setup. Please refer to Reportable Ranges Setup in CHAPTER 3, System Setup Options in this manual

for additional information.

Excessive Reference Drift – Sample to Calibration — The reference value for an ISE sample measurement drifted from the reference value of the calibration and exceeded the limit. The units are measured in ADCs and are a measurement of ISE sample electrode drift.

This flag may be triggered for CL, K, NA and CALC by excessive ambient room temperature shifts. CL may also experience this flag when running many urine samples or needs maintenance. Correct CL electrode by running serum samples to recondition the electrode.

K and CALC may see this error when electrode is newly installed. Refer to CHAPTER 9, Maintenance in this

manual for additional information.

A faulty calcium electrode MAY also cause sample reference drift errors on sodium and potassium results.

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

Reportable Ranges Setup

in CHAPTER 3, System Setup Options in this manual for additional information.

Out of Reportable Range High/Low — Result exceeds the operator defined reportable range high or low.

Refer to Reportable Ranges Setup

in CHAPTER 3, System Setup Options in this manual for additional information.

Probe Obstruction Detected — The system detected a block in the sampling system when sampling the requested samples. Check affected samples for clots, then reload. If issue still persists, refer to the UniCel

DxC Synchron Clinical Systems Reference Manual, CHAPTER 5, Advanced Troubleshooting, CC Hardware

Symptoms or MC Hardware Symptoms for additional investigation.

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

Reserved Racks/Obstruct

Detect

in CHAPTER 3, System Setup Options in this manual for additional information on reserved racks.

Sample Signal Noise — The difference between the high and low values of the eight sample readings has exceeded the limits allowed. Units are measured in ADCs and are a measurement of system noise observed during the sample cycle. Consistent flags may indicate poor system grounding.

Set Point Modification — The calibration being used for this specific result was performed with adjusted set point values. The test result associated with this Result Error code is directly affected by these calibration adjustments. Refer to

System Calibration in CHAPTER 4, Reagent Load/Calibration in this

manual for additional information.

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

Table 12.10

shows the most common system error messages in numerical sequence. It also shows the text that appears on the pop-up window that appears when the error occurs, the accompanying text that will be inserted into the Event Log, a description of the probable cause for the error and the recommended corrective action to take to resolve the problem.

Online Help is available for troubleshooting common error messages. On the DxC console, error messages contain links to the Online manuals.

Select the Help icon next to the event number to display specific information about the error. A grey Help icon indicates that the Instructions For

Use manual is not loaded. For error messages that do not have a Help icon next to the event number, refer to the UniCel DxC Synchron Clinical

Systems Reference Manual for troubleshooting information.

Online Manual Links

The system may display an “Error -- The page cannot be displayed” pop-up message when you select the

Event ID

button to link to the online manual from an instrument pop-up error message, or when you select a link in the online manual. To continue, record the Event ID, select

OK

from the Error pop-up message and then use the search feature of the online manual to find the topic you were seeking.

NOTE

To view the instrument pop-up error Event ID number, use the

(

ALT

)

+

(

F1

)

key combination to return to the instrument screen.

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

Home

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.

Home

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

Home

the system.

If the error continues, contact Beckman

Coulter Support Center for additional information.

If Reservoir is empty,

Make sure the Manual water inlet valve is turned on.

Make sure the instrument has not rolled on top of the water inlet lines.

Home

and restart the system.

If the error continues, contact Beckman

Coulter Support Center for additional information.

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

Load/Unload Modular

Chemistries (MC)

.

Make sure caps on pressurized bottles are tight.

Make sure Vacuum Accumulator canister in the rear of the Hydro is empty.

Contact Beckman Coulter Support Center for additional information.

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

Home the system.

Adjust pressure levels if necessary as follows:

Adjust pressure in Main system above 17 psi.

Adjust the high pressure system to 17 psi.

Adjust the low pressure system. The pressure range for the low pressure system is 8–11 psi. Set it at 10 psi.

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

Home the system.

Adjust pressure levels if necessary as follows:

Make sure the 25 psi (Main Pressure) gauge on the hydro reads within 24 to28 psi.

Adjust the 25 psi (Main Pressure) regulator as necessary.

When the 25 psi pressure is within range, make sure the High Pressure reading on the

Hydro Status screen is 17 ± 1.

Adjust the low pressure system. The pressure range for the low pressure system is 8–11 psi. Set it at 10 psi.

Contact Beckman Coulter Support Center for additional information.

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."

Home

the system.

If the instrument returns to Standby, adjust pressure levels if necessary as follows:

Make sure the 25 psi (Main Pressure) gauge on the hydro reads within 24 to28 psi.

Adjust the 25 psi (Main Pressure) regulator as necessary.

When the 25 psi pressure is within range, make sure the High Pressure reading on the

Hydro Status screen is 17 ± 1.

Adjust the 17 psi (High Pressure) regulator as necessary.

When the 17 psi pressure is within range, make sure the Low Pressure reading on the

Hydro Status screen is within range.

Adjust the 10 psi (Low Pressure) regulator as necessary.

If the instrument will not return to Standby, contact Beckman Coulter Support Center for additional information.

Check pressure levels and

Home the system.

Adjust pressure levels if necessary as follows:

Make sure the 25 psi (Main Pressure) gauge on the hydro reads within 24 to28 psi.

Adjust the 25 psi (Main Pressure) regulator as necessary.

When the 25 psi pressure is within range, make sure the High Pressure reading on the

Hydro Status screen is 17 ± 1.

Adjust the high pressure system to 17 psi.

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

Home

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

Shutdown .

If the problem continues contact Beckman

Coulter Support Center for additional information.

Likely cause is the Instrument computer has received an invalid or unexpected response. This is not caused by user input.

At the Red Message screen, select

Shutdown .

If the problem continues contact Beckman

Coulter Support Center for additional information.

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

Replace the Old Probe

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

(CC) .

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

Home

the system.

While the system Homes, check for possible interference issues.

If the system Homes successfully, restart the run and check the reagent probes and mixer for possible interferences (e.g., improper cable routing or not in alignment).

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

Install the New Probe

procedure.

If the Syringe is responsible, check for proper seating of syringe assembly.

Contact Beckman Coulter Support Center for additional information.

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,

Replace the

Sample and Reagent Probe .

If probe is clear and error continues, check for pinched Sample line tubing.

If the error continues contact Beckman Coulter

Support Center for additional information.

This error is caused by a Vertical or

Rotary motion error. This will cause the instrument to go into a Stopped state.

Raise canopy and check for obvious obstruction of the CC reagent Probe A.

Press the STOP button and Home

the system.

While system is homing, observe motion of the

CC reagent probe A. The probe should complete its operations in a smooth manner.

If the error continues, check the event log to determine the specific subsystem error. Refer to

Event Log .

If event log indicates a vertical error, make sure the reagent cartridges on the carousel are pushed in and seated properly.

Perform the appropriate vertical or horizontal

CC reagent Probe A alignment. Refer to step 3 in

the Install the New Probe

procedure.

Contact Beckman Coulter Support Center for additional information.

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

Event Log .

If event log indicates a vertical error, check that the reagent cartridges on the carousel are pushed in and seated properly.

Perform the appropriate vertical or horizontal

CC reagent Probe B alignment. Refer to

Event

Log

.

Contact Beckman Coulter Support Center for additional information.

Raise canopy and check for proper seating of syringe assembly.

Press the STOP button and Home

the system.

While system is homing, observe motion of the

CC reagent syringe. The syringe should complete its operations in a smooth manner.

If the error continues, contact Beckman Coulter

Support Center for additional information.

This error will occur whenever there is a motion error in the Reagent Switch (A/B valve). This error does not occur during a home, only runtime, primes, etc.

Press the STOP button and

Home

the system.

Contact Beckman Coulter Support Center for additional information.

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

Shutdown

.

When the DxC is turned off, manually unlatch the CC Reagent Compartment door. The latch is located below the CC reagent compartment door and above the instrument power switch.

Slide the latch to the left to open the compartment door.

At this time, the reagent carousel can be manually rotated, if necessary, to clear a jammed cartridge.

Close CC Reagent compartment door.

Power the instrument back up. Refer to

System

Power On/Boot

.

If the problem continues, contact Beckman

Coulter Support Center for additional information.

Make sure mixer has the necessary room to move.

Make sure the wiring and cabling are secured properly.

Make sure mixer paddle is seated firmly in its housing.

Home

the system.

If mixer appears out of position, perform rotary or vertical alignment.

If motion error continues, contact Beckman

Coulter Support Center for additional information.

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

Replace Cuvette Wiper

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.

Home

the system.

Check reagent cartridges for bubbles.

Perform Reagent Probe to Cartridge and

Reagent Probe Height in Cartridge Alignments.

Refer to step 3 of the

Replace the Old Probe

procedure.

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

Load/Unload Cartridge

Chemistries (CC) .

Cartridge must be reloaded to initiate level sense.

Check reagent probe alignment for any residual fluid in wash collar.

Consistent messages may indicate issues with the level sense function of:

reagent probe bead assembly

reagent probe alignments

level sense board

Contact Beckman Coulter Support Center for additional information.

Try flushing probe from the top. Refer to Flush the Sample and Reagent Probe .

Perform the CC Sample Probe Alignment

(Calibration). Refer to Step 3 of the

Replace the

Sample and Reagent Probe procedure.

Replace probe. Refer to Step 3 of the Replace the Sample and Reagent Probe procedure.

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

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 #

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

Home

the system.

Check for any obstructions in the sample rack handler and clear any obstruction found.

Home

the system.

Reload any incomplete racks.

Press the RUN button to resume testing.

Load a DIL1 Cartridge. Refer to Load/Unload

Cartridge Chemistries (CC)

.

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

Option)

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

Racks .

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

Racks .

If multiple obstruction errors occur, flush probe.

Refer to Flush the Sample and Reagent Probe .

Check tubing from top of probe to ODC sensor for crimps. If crimped, tubing will need to be replaced.

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

errors. Refer to Event Log .

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

Home

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

Cuvette Water Blank Status .

If a cuvette appears to be damaged, replace it

(extra cuvettes available in Spares kit and may be ordered).

Press the STOP button and Home

the system.

If prompted, select Shutdown.

When the console indicates the shutdown is complete, turn off the main power switch on the instrument and the computer.

Verify the instrument power connections.

Restart the computer and turn the instrument back on.

If the instrument fails to power on or the problem continues after the instrument has been rebooted, contact Beckman Coulter

Support Center for additional information.

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

Racks .

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

Reagent Probe

.

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

Priming MC Subsystems

(select Sample Delivery Subsystem.)

Probe may need to be replaced. Refer to

Replace the Sample and Reagent Probe .

If error continues, perform MC ODC Calibration

(Alignment).

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

Load/Unload

Reagent

.

If there are sample racks on the DxC sample wheel, request the system to unload racks.

Refer to Unload All 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

Unload All Racks

.

If the error continues, compare the racks shown on the Main screen with the racks present on the

Sample Carousel to make sure the rack is physically present.

If on Main screen, but the rack is not physically present, reboot system. Refer to

Shutdown .

If on Main screen, and the rack is physically present, shuttle latch may not have hooked the rack properly. Contact Beckman Coulter

Support Center for additional information.

If this error occurred during a rack unload, check the results for the samples in the misread rack.

Compare the number of the rack that was rejected with the racks currently on the analyzer by looking at the Main Screen.

Check the actual bar code that is on the rack correlates with the number that the system is rejecting.

Switch samples to a rack with a different ID or wait until the samples in the previous rack has completed testing and has been offloaded.

If the Main screen shows the Rack, but it is physically not on the instrument, use the Unload

All feature to clear the sample wheel. Refer to

Unload All Racks .

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

Tubes Validated for CTS

.

Make sure rack is designated properly as a 100 or 75 mm rack in the Reserved Rack screen.

Refer to Assigning or Reassigning Reserved

Racks .

Make sure the tubes are seated properly in the appropriate rack.

If tubes have been re-capped, make sure caps are fully seated in the tube.

If error continues perform cap piercer tube height alignment.

Contact Beckman Coulter Support Center for additional information.

Make sure the rack height is defined. Refer to

Figure 2.2, Reserved Racks/Obstruction

Detection Setup Dialog Box

.

This error will occur when the offload trays sensor has been triggered. This error is working as designed in most cases.

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

Shutdown .

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

Home

the system.

If the error continues after homing, Shutdown

the instrument and reboot.

If the problem continues after the instrument has been shutdown, contact Beckman Coulter

Support Center for additional information.

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.

Home

and restart the system.

If motion error continues, contact Beckman

Coulter Support Center for additional information.

This error encompasses all homing motions in the Sample Rack Handling

System (SRHS) and occurs whenever there is a homing issue during an

initial

boot. This includes the On Load

Assembly, Shuttle, Sample Wheel, and the Lifter. If the devices do not find their home position in time or they jam, the error will be flagged.

Check for any racks that may have jammed in the Sample Rack Handling System or if any of the devices have jammed together.

Check for other obstructions if no rack problem

(covers, stoppers, etc.)

Press the STOP button and

Home

the system.

If error continues after

Home , print screen and

check event log for specific sub-system homing error. Contact Beckman Coulter Support Center for additional information.

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

Replace Cuvette Wiper

to view wash head.

Press the DxC STOP button. Wait for the motors to release power (about 30 seconds, listen for the sound of the Smart Modules resetting) then

Home

the system.

If the error continues after homing, contact

Beckman Coulter Support Center for additional information.

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

Home

the system.

While the system Homes, check for possible interference issues. If the error continues after homing,

Shutdown the instrument.

If the problem continues after the instrument has been shutdown and rebooted, contact

Beckman Coulter Support Center for additional information.

Check Event Log for specific subsystem errors.

Press the STOP button and Home

the system.

Reboot. Refer to Shutdown

.

If the error continues, contact Beckman Coulter

Support Center for additional information.

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

ON/OFF

Switch

.

Check Ethernet cable connection at console, microhub and instrument.

Reboot system. Refer to Shutdown .

Contact Beckman Coulter Support Center for additional information.

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.

Home

and restart the test.

.

Unable to transition to Maintenance. The system may still be in a Running state.

Allow samples to complete before requesting maintenance.

Logs that the printing is down in the event log and displays the note to inform the user.

Reboot the DxC system. Refer to

Shutdown .

Review and reprint the missing reports.

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

Rgts/Cal Screen

Overview .

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

Cartridge Chemistries (CC)

.

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

Show the CTS Tracking Status

.

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.

Archive QC data.

Reload calibrator racks.

Make sure bar codes are readable. Refer to Bar

Code Labeling .

If there are 4 calibrators or less, they must all be in the same rack.

If more than 4 levels are required, levels 1–4 must be in the first rack loaded and the next rack loaded must contain the remaining levels.

Check the sample status. It may have been completed and reloaded. Verify the sample programming.

Could indicate a problem receiving sample programming from the LIS.

Reload calibrator racks.

Make sure bar codes are readable. Refer to Bar

Code Labeling .

If there are 4 calibrators or less, they must all be in the same rack.

If more than 4 levels are required, levels 1–4 must be in the first rack loaded and the next rack loaded must contain the remaining levels.

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

characters. Refer to

Code Labeling

Commands,

.

vacuum problem.

Valid Characters for Entries

Make sure the complete bar code is visible and there are no smudges or wrinkles. Refer to

Bar

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

Samples .

.

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.

Home

and restart the maintenance.

Load the reagent and retry the request. Refer to

Load/Unload Reagent

.

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 ,

Setup .

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

Host Communications ,

Setup

.

Check the LIS for status.

Go to

Host Communications

, Setup

. Exiting screen will force the system to reestablish communication.

Check cable connections.

Make sure the host setup parameters have not been changed.Refer to

Host Communications

,

Setup .

Wait for the system to get to Standby/Stopped/

Disabled/PVT/Diag/Maint or Align.

Reboot if necessary. Refer to

Shutdown .

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.

Refer to Shutdown

.

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.

Select

Pause only when at least one side of the

system is running.

Reboot if necessary. Refer to

Shutdown .

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

Home the

system.

To immediately shutdown, press the STOP button and wait to go to the Stopped state, then request Shutdown.

Reboot. Refer to 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

Shutdown

. 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

system. Refer to Shutdown .

Check the connections between the DxC

Instrument and the Console Computer.

If the problem continues, reboot the DxC

system. Refer to Shutdown .

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.

Home

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.

Refer to Backup the System .

Make sure the diskette is inserted correctly.

Try another diskette.

Refer to Backup the System .

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

Shutdown .

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.

Refer to Backup the System .

Use another disk if available.

Refer to Backup the System .

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.

Refer to Backup the System

Use another disk if available.

Refer to Backup the System .

.

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.

Refer to Backup the System .

Repeat Backup with different disk.

Refer to Backup the System .

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.

Refer to Backup the System .

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

10% bleach solution, 9-81 ,

9-84 ,

9-85 ,

9-87

, 9-113

1-Blade CTS option

See Cap piercer

1-Blade Narrow CTS,

2-5

1-Blade Thick CTS, 2-5

70% isopropyl alcohol,

9-14 ,

9-27

, 9-31 ,

9-81

A

Absorbance versus time, 7-8

AccuSense glucose sensor

Connector port, 9-60

Drain reaction cup for sensor, 9-59 ,

9-60

Gasket, 9-59 ,

9-62

Prepare prior to replacement, 9-60

Replace, six-month,

9-48

,

9-61

, 9-63

Stir bar and cup, clean, 9-62

Air filters

Change, 9-41

Clean, 9-41

Alarm/Annunciator

See Status Alarm/Annunciator

Alignment

See UniCel DxC Synchron Clinical Systems

Reference Manual

Alkaline buffer damper assembly

Adjust fluid level,

9-20

Fluid level high,

9-22

Fluid level low,

9-21

Check fluid level, 9-23

Replace alkaline buffer reagent, 9-18

Archive QC Data,

5-23

Auto ORDAC,

3-4

Auto serum index,

3-4

Autoloader,

1-9

B

Backup,

11-13

Alignment data,

11-13 ,

11-16

System parameters, 10-2 ,

11-13

Bar code reader, 1-19

Hand-held (MC),

1-13

Reagent, CC, 1-19

Sample,

1-10

Bar codes, QC, 5-7

Printing, 5-7

Beer's Law, 1-54

Boot

Full boot,

10-14

Buttons,

1-xxxiv

C

Calibration

Acceptance limits,

4-27

Bypass,

4-25

Calibrator set point modifications, 4-28

Enzyme validator,

4-23

Error detection, 1-53

Extending calibration time, 4-26

Failure messages,

4-18

Formulas

Endpoint and first-order, 1-44 –

1-49

Non-linear, 1-50

, 1-51

Override, 4-24

Reprint calibration report,

4-31

Request

Canceling a calibration request, 4-18

Slope offset adjustment, 4-29

Status,

4-14

Within-lot calibration,

4-19

Designations, 4-22

Enabling within-lot calibration, 4-19

Index-1

Index

Index-2

Frequency,

4-19

Limitations, 4-22

Cap piercer

1-Blade CTS option

CTS Auto-Gloss

1-Blade Narrow CTS,

1-11

1-Blade Narrow CTS option, 9-32

1-Blade Thick CTS, 1-11

1-Blade Thick CTS option,

9-32

See CTS

Carousel,

1-6

Cartridge chemistries (CC),

1-43

Calibration theory, 1-43 –

1-53

Spectrophotometric methods,

1-54

Cartridges, 1-19

Reagent, 1-19

CC — Cartridge chemistry,

9-2

CC reagent mixer, clean,

9-31

CC sample mixer, clean,

9-31

CC sample probe, reagent probes and mixers

Automated cartridge chemistry probe cleaning

Load CCWA, 9-104

CCWA — Cartridge chemistry wash solution,

9-2

Chemistry parameters,

8-4

Chemistry print name, defining, 3-6

Chemistry, configuring,

3-5

Clearing chemistries,

3-6

Deleting a chemistry, 3-6

Inserting a chemistry, 3-6

Chloride Electrode tip, Replace,

9-65

Closed Tube Sampling

See CTS

CO

2

alkaline buffer reagent straw and line, bleaching

Line #33, 9-87

CO

2

measuring electrode membrane, 9-74

Broken, 9-79

ISE service, 9-75

Remove, 9-75

Replace,

9-77

Wrinkled,

9-79

Configuration, system, 3-31

Constituent code,

5-6

, 5-11

Control,

5-9

5-14

Bar codes,

5-7

Constituent code,

5-6 ,

5-11

Definition,

5-4

Deleting,

5-13

Editing, 5-9

Fields,

5-6 ,

5-11

File number,

5-6

, 5-11

Printing,

5-13

QC chart,

5-17

QC file list,

5-14

QC summary,

5-15

Reviewing, 5-12

Copy to disk feature, 5-21

Creatinine clearance results

Calculation, 3-23

Critical ranges, 3-19

Critical Result Rerun,

3-15

Critical result rerun, 7-6

CTS — Closed Tube Sampling,

9-2

CTS (Closed Tube Sampling)

1-Blade Narrow CTS option,

1-11

1-Blade Thick CTS option,

1-11 ,

2-5

Blade count,

10-3

CTS Auto-Gloss, 2-v ,

11-2

CTS Count,

10-3

CTS Tracking, 2-x

, 10-7

4-Blade Foil CTS option, 2-5

CTS Auto-Gloss,

9-10

CUPs lamp and sensor calibration, 9-29

, 9-30

Cuvette reaction system,

1-21

Cuvette washer probe, inspect

Blocked probe,

9-108

Cuvette washing

Wash station, 1-23

Cuvette water blank status, 10-6

Cuvette wiper

Reinstall,

9-12

Replace, 9-10

Cuvettes

Automated wash all cuvettes, 9-110

D

Data storage, 7-1

Results, 7-1

Sample programs,

7-1

Database version, 3-23

Date/time setup,

3-13

Deleted results,

11-7

Deleting,

5-19

Control,

5-12

Critical result rerun,

7-6

QC data point,

5-20

Demographics, 3-14

Index

Dilution factor, 6-10

Drain assembly, 1-26

Drugs of abuse testing (DAT),

1-53

E

Editing

Control, 5-9

EIC, 9-81

EIC — Electrolyte injection cup, 9-2

EIC ports, flushing, 9-81

9-87

ISE service,

9-81

Electrolyte injection cup (EIC), 1-15

Electrostatic Discharge, 9-1

Enable/disable modules, 10-16

,

10-17

Enzyme validator,

4-23

Enzyme verification,

1-53

Error detection

See Calibration

Error detection limits,

8-13

Event log, 11-6

Exit check criteria,

8-17

,

8-18

Expanded user defined chemistry feature,

8-20

Extinction coefficients,

8-16

ICS/smart module status, 10-5

Immediate reporting,

3-14

Instrument commands,

10-8

Intended use,

1-xxxiii

ISE — Ion selective electrode (flow cell

module), 9-2

ISE drain cleaning, six-month

Drain top,

9-90

Drip screen,

9-90

ISE service, 9-89 ,

9-92

ISE module, 1-13

ISE reference solution,

9-52

ISE service, 9-54

, 9-65

K

Keyboard,

3-29

L

Labels,

2-xv –

2-xxiii

, ??– 2-xxiv

Language/keyboard, selection, 3-29

Levey-Jennings,

5-16

Log fields,

1-40

, 1-41

LPIA (large particle immuno assay)

module, 1-21 ,

1-22

, 8-1 ,

8-6 ,

10-6

I

F

Failure messages, calibration,

4-18

File number,

5-6 ,

5-11

Flow cell (ISE), 1-16

Flow cell flush kit,

9-92

Flow cell tubing #23, 9-93

Flow cell tubing #27, 9-93

Flow cell tubing #35, 9-93

Flow cell, flushing

ISE service,

9-92

9-95

H

Hazards, 2-v

Home,

10-8

Host specifications

See Host Interface Specifications Manual (P/

N A16150)

Hydropneumatic system,

1-24

Status, 10-5

Icons,

1-xxxiv

M

Main screen, 1-27 –

1-42

Post run summary, 1-39 ,

1-42

Pre run summary, 1-39 ,

1-42

Results recall, 1-38

,

1-39

Sample unload, 1-39

Main screen and program structure,

1-27

Maintenance,

9-1 ,

11-6

Manual

Conventions,

1-xxxiii

How to use, 1-xxxv

Scope,

1-xxxiii

Manual assignments,

6-7

Math models, 1-50 ,

1-51 ,

8-6

MC — Modular chemistry,

9-2

MC components, reassemble,

9-30

Mixer wash cup, 1-20

Reagent, 1-20

Modem,

11-12

Modular chemistries (MC),

1-53

Basic components,

1-17

Modular reagents

Index-3

Index

Index-4

Check levels,

9-10

Modules,

1-17

Modules, enable/disable,

10-16

N

No Foam, 9-10

O

Offload track, 1-9

On/off switch, 10-13

ORDAC,

6-10

Auto ORDAC,

3-4

Manual, 6-10

P

Panels,

3-15

Patient results

Critical results rerun,

3-14

, 3-19 ,

7-6

Pause, 10-9

PHOSm, cleaning precipitate

Protein precipitate,

9-106

Photometer assembly,

8-6

Post run summary,

1-39

, 1-42

Potassium and calcium electrode tips

Replacing, six-month

ISE service,

9-54

Removing/installing,

9-52 –

9-58

Power Subsystem Status,

10-4

Pre run summary,

1-39

,

1-42

Precautions,

2-viii

2-xiv ,

5-9

Prime,

11-1

Printers,

3-30

Printing,

5-13

, 7-7

Control,

5-13

Data,

1-38

QC chart,

5-17

QC file list, 5-14

Recalled results, 7-7

Priority

Position,

1-9

Priority load,

1-9

Probes, clean,

9-14

Processing parameters, 8-8

Programming samples, 6-1

Batch,

6-11

Dilution factor, 6-10

Manual, 6-10

Manual assignments,

6-7

ORDAC,

6-10

Rack status, 6-3

Rack/cup position,

6-4

Sample ID,

6-4

Sample status,

6-4

Pushers,

1-10

Q

QAP Disk,

5-21

Quad-ring

BUNm/UREAm electrode, 9-27

CO

2

measuring electrode,

9-76

Potassium and calcium electrode,

9-57

,

9-67

Quality Assurance Program (QAP)

Copy to disk feature,

5-21

Quality control (QC),

5-1 –

5-25

Chart, 5-16

Printing QC bar code assignments,

5-7

QC action log, 5-20

QC chart,

5-16

QC file list,

5-14

Displaying,

5-14

QC log, 5-18

Summary, 5-15

R

Racks, 1-7

Sample, 1-7

Sizes, 1-7

Status,

6-3

Ratio pump, 1-14

Reaction carousel, 1-21

Cuvettes, 1-21

Reaction type,

8-4

Reagent carousel, 1-19

Reagent cartridges, 1-18

Reagent handling system, CC, 1-17

Reagent parameters,

4-10

Loading,

4-11

Reagent status

Sorting reagent status

Days left,

4-3

Tests left,

4-3

Reagent syringe,

9-43

See also Sample and reagent syringes,

replacing three-month

Recalling results

Index

Displaying, 7-5

On-board samples, 1-38

Patient ID, 7-4

Printing,

7-7

Rack and position, 7-3

Run date/time, 7-4

Sample ID, 7-2

Replicates,

3-16

Reportable range, 3-17

Reports,

3-16

Statistical summary, 7-10

Reserved racks, assigning,

2-xiii

Reset,

10-12

Restore,

11-13

Results, 1-39

Results recall, 1-38

,

7-1

Main screen, 1-38

Retainer nut,

9-26 ,

9-57

, 9-62 ,

9-67

Review, 5-24

Review results,

1-41

Reviewing,

5-12

S

Sample

Carousel, 1-12

Gate, 1-10

Handling system,

1-6

ID, 6-5

Log, 1-39 –

1-41

Programming

See Programming samples

Racks, 1-7

, 2-2

Replicates, 3-16

Type

Default,

3-13

Sample and reagent syringes, replacing threemonth

Checking for bubbles, 9-47

Plunger rods,

9-44

Syringe rod replacement, 9-44

Sample syringe,

9-43

CC sample syringe, 9-44

MC sample syringe,

9-44

Serum index

Auto ORDAC, 3-4

Serum Index result, 3-15

Service

Monitor, 3-27

See also Metering Manual (P/N 967259)

Setup,

3-30

Setup

Screens,

3-1

Shutdown, 10-12

Shuttle, 1-10

Silicone compound,

9-28

Smart modules

Status,

10-5

Sodium Azide preservative,

2-vii

Software version,

3-23

Special calculations, 3-20

Specifications, system

Clearances, 1-2

Elevation, 1-3

Operating temperature, 1-3

STAT, 3-14

Statistical summary report,

7-10

Status

Alarm/Annunciator,

3-32

See also System status,

10-1

Status-cycle count,

10-2

Stop print,

10-11

Surfaces and covers, cleaning,

9-112

Symbols, 2-xv –

2-xxiii , ??–

2-xxiv

System configuration, 3-31

System description, 1-1

System hazards

Moving parts,

2-vi

System Status,

10-1

T

Tables,

3-10

Beckman Coulter defined chemistries,

3-10

Predefined special calculations,

3-21

Predefined special formulas,

3-21

Temperatures, 10-2

Timed urine results

Constants and factors,

3-23

Total protein cup maintenance,

9-13

Touch Screen Calibration,

11-16

U

Unload all, 10-18

Unloading samples, 1-39

Update,

3-31

See Version upgrade

UPS (Uninterruptible Power Supply),

10-13

User,

8-3

Index-5

Index

User defined reagents

Configuring, 3-5

Defining,

8-3

– 8-19

Deleting,

3-6

Inserting,

3-6

Minimum operating requirements,

8-1

Removing,

8-19

Setup,

3-24

, 8-3

V

Valid entries, 6-5

Version information,

3-23

Version upgrade,

3-31

W

Warnings, reagent and calibration status,

4-15

Wash Concentrate II,

9-10

Waste B, pause/resume,

10-15

Wavelength

Primary,

8-6 ,

8-15

Secondary,

8-6

, 8-15

Westgard rules,

5-2 ,

5-3

Wheel

See Carousel

Wrist ground strap, 9-43

Index-6

www.beckmancoulter.com

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© 2010 Beckman Coulter, Inc.

All Rights Reserved

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