Beckman Coulter UniCel DxC 600, UniCel DxC 600i, UniCel DxC 800 Instructions For Use Manual

Instructions For Use

Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

Volume 1

UniCel

®

DxC Synchron®

Clinical Systems

For In Vitro Diagnostic Use

This manual is intended for
UniCel® DxC 600
UniCel® DxC 800
UniCel® DxC 600i

A13914AF
April 2010

Instructions For Use

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：[phone]

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

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:

Revision History

Safety Notice:

• Added statement to Environmental Conditions Precautions

• Added Patient Results

• Added Quality Control

• Added Sample Integrity

CHAPTER 3, System Setup Options:

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

Table 3.4, UniCel DxC 800 Predefined Special Calculation Formulas

CHAPTER 9, Maintenance:

• Added Twice Weekly bullet to Maintenance Schedule

• Added Twice Weekly Maintenance

• Added bullets to Weekly Maintenance

• Added Twice Weekly Maintenance procedure

• Added cleaning statement to Weekly Maintenance

• Added statement to Clean Flow Cell, Cups and CC Probes/Mixers (Automated)

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

A13914AF

iii

Revision History

iv

A13914AF

Summary of Hazards

A011460L.EPS

Introduction

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

Safety Notice

Warnings or Cautions within the procedures

Biohazardous Materials Hazards

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

456161-B

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

CAUTION

A011459L.EPS

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

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

No Foam Reagent Pressurization Hazard

The No Foam container is pressurized during system operation and must be properly depressurized
prior to servicing to avoid sudden depressurization and potential exposure of the skin or eyes to the
No Foam solution. To release the air pressure, disconnect the white quick connector located at the
supply side of the container. If inhaled, move exposed individual to fresh air. If skin or eye contact
with the solution occurs, flush the affected area thoroughly with water for at least 15 minutes. In
both cases seek medical attention. Refer to the No Foam Material Safety Data Sheets (MSDS) for
additional information.

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A13914AF

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.

Safety Notice

Summary of Hazards

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.

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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
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.

Caution

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

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.

Safety Notice

Summary of Precautions

Blood Barrier Collection Tube Precautions

When blood collection tubes that contain physical barriers are used, extra care should be exercised
to ensure that the barrier is tightly packed. Loose particles from the barrier could coat or plug the
sample probe, flow cell, chemistry modules, electrolyte injection cup (EIC), or cuvette wash station.

BUNm/UREAm Electrode Precautions

To prevent damage to the BUNm/UREAm electrode, do not insert the stir bar removal tool,
applicator stick, or any other object into the BUNm/UREAm cup unless the electrode has been
removed. Remove the electrode before you remove the stir bar.

CC Subsystems Priming Precautions

If any two of the CC Subsystem items are selected, all three are primed automatically. Make sure that
all three areas are ready to be primed.

CO2 Membrane Replacement Precautions

Do not touch the membrane surface when installing the quad-ring.

Covers, Doors and Shields Precautions

To ensure optimum performance of the system, operate the system with reagent doors and all
shields and covers in place. To prevent possible motion errors, verify the proper positioning of any
removed and reinstalled cover or shield.

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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

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.

Safety Notice

Summary of Precautions

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.

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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

xii

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.

A13914AF

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.

Safety Notice

Summary of Precautions

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.

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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

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.

Safety Notice

Hardware Symbols and Labels

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.

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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

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.

Safety Notice

Hardware Symbols and Labels

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.

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xvii

Safety Notice

456161-B

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

CAUTION

A011459L.EPS

A011460L.EPS

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.

General Biohazard

These caution symbols indicate biohazardous risk from possible patient specimen contamination.

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

Class II Laser Caution Warning

A012936L.EPS

CAUTION

SHARP OBJECTS - REFER

SERVICING AND MAINTENANCE TO

QUALIFIED SERVICE PERSONNEL.

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.

Safety Notice

Hardware Symbols and Labels

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.

A13914AF

xix

Safety Notice

A012937L.EPS

THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION.

471830-AA

CAUTION
PARTS MOV E
AUTOMATICALLY

A015047L.EPS

A012938L.EPS

THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION.

471831-AA

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.

Moving Parts Caution

A label reading, "CAUTION PARTS MOVE AUTOMATICALLY" is placed inside the offload track, on the
left side of the back wall.

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.

xx

A13914AF

Read Manual Caution

A012939L.EPS

270-455774-A

CAUTION - READ MANUAL

BEFORE OPERATING

ATTENTION - CONSULTER LA NOTICE

AVANT DE FAIRE FONCTIONNER.

A011540L.EPS

BECKMAN COULTER, INC

MADE IN U.S.A. MARCA REG

PRODUCT COMPLIES WITH
21 CFR CHAPTER I, SUBCHAPTER J

MANUFACTURED DECEMBER 2004

LABEL P/N 448229 AB

S

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.

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.

Safety Notice

Hardware Symbols and Labels

Laser Certification Label

This label is found on the back, bottom edge of the system. It provides information about the laser.

A13914AF

xxi

Safety Notice

A012942L.EPS

ETHERNET

SERIAL PORT

A012943L.EPS

WASTE B
OUTLET

WASTE OUTLET

WASTE B

SENSOR

D. I. WATER INLET

MAX. PRESS. 100 PSI (689 kPa)

136

137128

D.I. FIBER

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.

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.

xxii

A13914AF

Recycling Label

A016608L.EPS

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.

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.

Safety Notice

Hardware Symbols and Labels

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

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).

Safety Notice

Documentation Symbols

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

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.

IMPORTANT is used for comments that add value to the step or procedure being performed.

A13914AF

xxv

Safety Notice

Documentation Symbols

xxvi

A13914AF

Revision History, iii

Safety Notice, v

Introduction, xxxiii

CHAPTER 1: System Description, 1-1

System Description, 1-1

Contents

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

xxviii

System Configuration, 3-31

Version Upgrade, 3-31

Status Alarm/Annunciator, 3-32

Chemistry Update, 3-32

Auto Generation of Control, 3-33

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

Contents

Chemistry Bypass, 4-25

Extend Calibration Time, 4-26

Calibration Acceptance Limits, 4-27

Calibrator Set Point Modifications, 4-28

Slope Offset Adjustment, 4-29

Reprint Calibration Reports, 4-31

CHAPTER 5: Quality Control, 5-1

Quality Control, 5-1

Define a Control, 5-4

Control ID Assignments, 5-7

Run Control Samples, 5-7

Edit a Control Definition, 5-9

Review a Control Definition, 5-12

Delete a Control, 5-12

Print QC Ranges, 5-13

QC File List, 5-14

QC Summary, 5-15

QC Chart (Levey-Jennings), 5-16

QC Log, 5-18

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

Archive QC, 5-23

xxix

Contents

Review Archived Data, 5-24

CHAPTER 6: Sample Programming and Processing, 6-1

Overview, 6-1

Prior to Programming, 6-2

Identify Samples, 6-4

Sample Programming and Processing, 6-6

Additional Programming Information, 6-10

Clear Samples, 6-12

CHAPTER 7: Results Recall, 7-1

Overview, 7-1

Recall Results by Sample ID, 7-2

Recall Results by Rack and Position, 7-3

Recall Results by Patient ID, 7-4

Recall Results by Run Date/Time, 7-4

Display Recalled Results, 7-5

Edit Critical Rerun Result, 7-6

Print Recalled Results, 7-7

Send Results to the Host, 7-8

Absorbance Versus Time, 7-8

Statistical Summary Report, 7-10

CHAPTER 8: User Defined Reagents, 8-1

Overview, 8-1

Requirements and Precautions, 8-1

User-Defined Reagent Setup, 8-3

Chemistry Parameters, 8-4

Processing Parameters, 8-8

Error Detection Limits, 8-13

xxx

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

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

Contents

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

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

Introduction

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 Description

Combination Keys Keyboard characters that when pressed, in conjunction with the

Command buttons
(buttons with names on
a screen)

Control or Alt key, invoke a command. They are enclosed in
+ sign between each key.

Examples:

+

Alt

(

Buttons with names are bold and use a SansSerif font.

Examples:

Select OK.
Select

)

or

(X)

Cancel.

+

(

Ctrl

+

Alt

)

Delete

(

)

(

)

(

)

with a

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xxxiii

Introduction

Manual Conventions

Table 1 Conventions Used in this Manual (Continued)

Function buttons Function buttons are bold and use a SansSerif font.

Convention Description

Example:

Select Print F10.

Icon buttons Icon buttons are bold and use a SansSerif font.

Example:

Select Samples from the menu bar.

Instrument buttons Buttons on an instrument are bold and use a SansSerif font. They may

be all upper case or initial caps.

Example:

Press the STOP button.

Keyboard keys

Keyboard keys are enclosed in

Examples:

(X), (→), (

Ta b

), (

Enter

)

.

(

)

Pull-down menus Use the pull-down menu to see a list of options you can select.

Example:

Select the Calibrator Name pull-down menu at the top of the Assign

Barcode/Rack

dialog box to view the list of calibrators.

Text field Names in the text fields are bold and use a SansSerif font, followed by

the word "field".

Example:

Type the Patient ID in the Patient ID field.

xxxiv

A13914AF

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.

Introduction

How to Use this Manual

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

• To enter a range of Sample IDs,
— Type the Sample ID at the beginning of the range in the

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.

Sample IDs field.

Range field.

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xxxv

Introduction

How to Use this Manual

xxxvi

A13914AF

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.

CHAPTER 1

System Description

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 Requirement

Installed by The DxC system is installed completely by Beckman Coulter

Installation Category II

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1-1

System Description

Operational Conditions

Clearances

Table 1.2 System Clearances

Area Affected Clearance Needed

Left Side Minimum of 6 inches (15.2 cm) clearance or 12 inches (30.5 cm) to access smart

Right Side Minimum of 18 inches (45.7 cm) clearance when monitor on swing arm is in use.

Back Zero inches. The venting design of the system allows for "0 inch" clearance at the

Top Minimum of 22 inches (55.9 cm) from highest point of system.

Front Minimum of 25 inches (63.5 cm) to open doors.

Sunlight and Drafts

Do not place the system in direct sunlight or in drafts. Both of these conditions may affect the
temperature control of the system.

modules.

back.

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

Operating range 200–240 VAC ± 10% (180–264 VAC)

Frequency 50/60 Hz

BTU generated 10,500 BTU/hour

Power connector 20 A current rating, NEMA L6-20R twistlock in-line connector

Item Requirement

14 A at low line, exclusive of power on surge

1-2

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Table 1.4 Power Requirements – DxC Console (PC System and Monitor)

Item Requirement

Operating range 100–120 VAC ± 10% (90–132 VAC); 4A

OR
200–240 VAC ± 10% (180–264 VAC); 2A

Frequency 50/60 Hz

BTU generated 1,500 BTU/hour

Power connector 15 A current rating, IEC 320 standard connector

Table 1.5 Power Requirements – Okidata B4350 LED Printer

Item Requirement

Operating range 110–127 VAC ± 10% (99–140 VAC); 3A

OR
220–240 VAC ± 10% (198–264 VAC); 1.6A

Frequency 50/60 Hz

System Description

Operational Conditions

1

BTU generated 1228 BTU/hour (printing); 34 BTU/hour (standby power save)

Power connector 15 A current rating, IEC 320 standard connector

Notes on the System Power

The system can operate from any standard 3-wire electrical outlet and is wired as shipped from the
factory to operate on 220 VAC, 50/60 Hz.

IMPORTANT

protection of the electronic circuitry.

Line Voltage from the electrical outlet should be free of spikes, fluctuations, and dropouts for

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 Specification

Environment Indoor use only

Ambient temperature +18°C to +32°C

A13914AF

Warm-up time 30 minutes (time to reach operating temperature)

Relative humidity 20–85% relative, non-condensing

Elevation Up to 4,200 ft (1280 m)

1-3

System Description

Operational Conditions

Water Requirements

Table 1.7 Water Requirements

Item Specification

Flow Rate 0.6 L/min peak flow rate, 16 L/hr minimum continuous flow rate

Temperature +15°C to +25°C

Water pressure Deionized water entering the system must be 30–90 psi.

Table 1.8 Water Quality Requirements

CLSI (CLRW) 4TH Ed. C03 --A4

Formerly NCCLS (Type I & II)

Notes Replaces Type I & II.

4th Ed. C03 --A4

CLSI

CLRW

Organic Impurities

Total Organic Carbon (TOC)

Microbiological Impurities

Maximum microbial content colony
forming unit (CFU/mL)

Ionic Impurities

Minimum resistivity,
megohm.centimeter
(MΩ. Cm@25C)

Particulate & Colloid Content Purification process

pH Not Applicable Not Appiicable

Maximum silicate (mg/mL) SiO

500 ng/g TOC (Total Organic
Carbon) parts per billion (ppb)

10 CFU/mL 10 CFU/mL

10 MΩ. Cm 1.0 MΩ.Cm

requirement only: water
filtration using 0.22 μm pore
size to remove microorganisms
and particulates

Not Applicable Not Applicable

2

Beckman Coulter Requirements

Not Applicable

Purification process
requirement only: water
filtration using 0.22 μm pore
size to remove microorganisms
and particulates

Other System Specifications for IEC-1010 Compliance

Table 1.9 IEC-1010 Specifications

Item Specification

Pollution Degree 2

EN55011 Meets Class A

Maximum Sound Pressure ≤ 65 dBA average over 8 hours with covers down at 1 meter away from

the instrument at +25°C

1-4

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Table 1.9 IEC-1010 Specifications

Item Specification

Maximum Leakage Current DxC 600: 222 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

DxC 800: 240 μA at 240V, 50Hz

System Description

System Components

1

• 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)

*

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* Equivalent to Near Infrared Particle Immuno Assay (NIPIA).

1-5

System Description

A011869P.EPS

4

3

1

2

5

Sample Handling System

Figure 1.1 UniCel DxC 600/800 Analyzer (600 shown)

1. Modular Chemistry (MC) Section

2. Cartridge Chemistry (CC) Portion

3. Autoloader

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

4. Dual Reagent Carousel

5. Operator Console

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

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Sample Racks

A sample rack is a high -strengt h, plastic , centrifugable ho lder desig ned to h ouse up to f our sa mples.
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:

System Description

Sample Handling System

1

IMPORTANT

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 12 × 75 mm tubes

16 × 75 16 × 75 mm tubes

13 × 100 13 × 100 mm tubes

16 × 100 16 × 100 mm tubes

Adapters are provided to adapt various sized sample tubes (secondary tubes) to the short

Rack Accepts These Cups and Tubes

13 × 75 mm tubes

0.5 mL cups

2.0 mL cups

0.5 mL cups

2.0 mL cups

Capillary collection tubes (use with the capillary tube adapter)

Beckman Coulter Microtubes

16 × 92 mm tubes

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16.5 × 100 mm tubes

Beckman Coulter 0.5 mL Cup Insert (PN 467406)

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

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Autoloader/Offload Track

A011870P.EPS

2 3 764 5

1

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.

System Description

Sample Handling System

1

IMPORTANT

autoloader.

Figure 1.3 Sample Loading Area

1. Pushers

2. Run Button

3. Priority Load Button

4. Autoloader

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

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.

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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-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

1

Cap Piercer Configuration Tube Type Tube Size

1-Blade Thick CTS Becton Dickinson VACUTAINER with

HEMOGARD

Greiner VACUETTE 13 × 75 mm

1-Blade Narrow CTS Sarstedt S-Monovette

a. This tube requires a special 5.5 mL rack (PN A18642).

13 × 75 mm
13 × 100 mm
16 × 100 mm

13 × 100 mm

75 × 15 mm

92 × 15 mm

a

Refer to Documentation Symbols in the Safety Notice section, for a description of the CAUTION
labels for the Cap Piercer.

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1-11

System Description

A015903P.EPS

1

2

3

4

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. Liquid Level Sense Assembly

2. Sample Probe (MC)

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.

3. Collar Wash

4. Sample Carousel

1-12

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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

Figure 1.5 Modular Chemistry Reagent Storage Area

System Description

Modular Chemistry (MC) System

alkaline buffer which is located on the ISE module.

2

1

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.

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1-13

System Description

A015904P.EPS

6

54321

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. Solenoid Valve (example)

2. Cylinder 1

3. Cylinder 2

4. Cylinder 3

5. Outlet Line (example)

6. Inlet Line (example)

1-14

A13914AF

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

System Description

Modular Chemistry (MC) System

1

1. Waste Outlet

2. Flow Cell Outlet

3. Buffer Inlet

4. Reference Inlet

5. DI H

O Inlet

2

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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

5. CO

Reference Electrode

2

Electrode

2

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

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Chemistry Reaction Modules (Basic Components)

A015905P.EPS

3

4

5

1

2

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)

System Description

Cartridge Chemistry (CC) Reagent Handling System

1

1. Circuit Board (behind protective shield)

2. Reaction Cup

3. Reaction Cup Housing

4. Mixer Motor Assembly

5. Reagent Pump Assembly

Cartridge Chemistry (CC) Reagent Handling System

Introduction

The Cartridge Chemistry Reagent Handling system is composed of the following components:

• Reagent cartridges

• Reagent carousel

• Reagent probe assembly

• Reagent mixer assembly

• Mixer wash cup

The Reagent Handling system is used to transfer reagent from the individual cartridges to the
reaction cuvettes for processing and analysis of the requested chemistry tests.

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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

Reagent Carousel and Reagent Bar Code Readers

The Reagent Carousel Compartment provides an on-instrument storage area for the individual
reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time. Refer
to Figure 1.11.

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

The Bar Code Reader, (refer to Figure 1.11), situated near the front of the Cartridge Chemistry
reagent access door, scans each label during the loading of reagent cartridges. Only the reader for
the selected carousel is active. An audible signal acknowledges successful reading of the label.

Figure 1.11 CC Dual Carousels with Two Bar Code Readers

1

2

System Description

Cartridge Chemistry (CC) Reagent Handling System

1

1. Top Positions 31–59

2. To p Ba r Co d e Re a d e r

3

4

A007408P. E P S

3. Bottom Positions 1–30

4. Bottom Bar Code Reader

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1-19

System Description

A015908P. E P S

2

4

1

3

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. Reagent Mixer

2. CC Reagent Probe A

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.

3. CC Reagent Probe B

4. Collar Wash

1-20

A13914AF

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.

System Description

Cuvette Reaction System

1

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.)

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1-21

System Description

A015909P.EPS

2

1

3

Cuvette Reaction System

Figure 1.13 Reaction Carousel Area (Typical – Cover Removed)

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

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

System Description

Cuvette Reaction System

1

1. Probe #1

2. Probe #2

3. Probe #3

4. Probe #4

5. Wash Sta tion

A13914AF

1-23

System Description

A016497P.EPS

6

1

2

3

4

5

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)

1. Wash Concentrate Solution

2. No Foam Reagent

3. DI Water Canister

1-24

4. Wash Solution Canister

5. Wash Concentrate Re servoir

6. Auto-Gloss

A13914AF

Function

A015911P.EPS

2

4

5 6 7

1

3

System Description

Hydropneumatic System

The function of the hydropneumatic system is to provide the following media to the different
functional areas of the instrument:

• Vac uum

• Compressed air

• Diluted wash solution

• Deionized water

Figure 1.16 DxC 800 Hydropneumatics (left side)

1

1. Waste B Exit Sump

2. Waste Exit Sump

3. DI Water Inlet On/Off

4. Waste Sump

A13914AF

5. Waste B Sump

6. DI Water Reservoir

7. Vacuum Accumulator

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 To start the test process.

Priority To prioritize the loading of a rack by creating a space in front of the autoloader for

loading the next rack into a priority position on the sample carousel. It does not alter
the sample priority (STAT or routine) previously defined in sample programming.

Stop To stop the process. The stop button should be used only under the following

conditions:

• To stop instrument motions

• To conduct a maintenance/repair activity

• To home and realign mechanical components without rebooting

Primary Function

1-26

A13914AF

Main Screen and Program Structure

E011950S.EPS

5

6

7

4

3

1 2

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

System Description

Main Screen and Program Structure

1

1. CTS Indicator

2. Host Indicator

3. System Status Indicator

A13914AF

4. Menu Bar

5. Sample Status Icons

6. Rack Status Area

7. Function Bar

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 Status Description

CTS This indicator (1) in Figure 1.17, appears in the blue bar at the top left side of the

Host This indicator (2) in Figure 1.17, appears on the blue bar at the top right 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."

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

Printing The indicator appears at the middle of the operator screens. When the indicator

appears, you must reboot the DxC system to restart printing.

System Status 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

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 Status Description

Not Programmed Indicates a sample has been loaded without any programming associated with that

Sample ID.

Query Pending Sample is waiting for specific program information to be downloaded from the host.

In Progress Sample has been identified and is currently being processed.

Aspirated Indicates whether an initial aspiration of the sample has been accomplished.

Incomplete Sample has some tests that are still pending.

Complete All tests for sample have been completed.

1

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

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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

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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

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1-37

System Description

Main Screen and Program Structure

Recall Results for On-board Samples

To preview the results of tests In Progress, before the rack is unloaded from the system, perform the
following procedure.

1

Select the sample for the desired results. The sample is highlighted.

2

Select Results F1. The results for any completed tests for the requested sample are shown along
with the status of any pending tests.

3

Select one of the function keys:

Print F8 - to send completed results to the printer.

•

• Host F6 - to send completed results to the host.

Accessing the Help System

Help is available online in multiple supported languages. To reach the online Help system,

• Select the Help icon , or

• Use the combination keys

The manual opens up full-screen in the language selected in System Setup. You can use the
combination keys
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
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.

(

ALT

+

ALT

(

+

to toggle between the active screen and the last accessed page of

)

(F1)

from any screen.

)

(F1)

OK from the Error

Print Data From a Screen

Many screens contain data that may be printed by selecting Print F10. Pressing the
the keyboard also causes the current screen to print, regardless of whether the

available.

1-38

PrtScn

(

Print F10 option is

key on

)

A13914AF

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
in yellow. The yellow highlight disappears when the key is selected. The error will stay in the
Sample Log screen for 12 hours.

System Description

Main Screen and Program Structure

Log F8 key is highlighted

1

•

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

See the log Log F8 from the Main screen

To... Select...

See more pages

Print the log (present list of sample history)

Page Up

(

PRINT

)

or

Page Down

(

NOTE This printout contains the same information as the

body of the window. This window remains in view after
the print button is selected.

Exit and return to the Main screen OK

Description of Log Fields

Table 1.16 Sample Log Fields

Field Description

Rack The rack in which the sample was run.

Position (Pos) The position of the sample in the rack when it was run.

Sample ID There are two ways to get this sample ID:

1. The system reads the bar code.

2. Manually input a sample program.

If there is no sample ID, there are two possible fields:

• If there is no sample ID then "NO ID" appears.

• If there is no sample ID and it is required, then a status of

Not Programmed appears.

)

1-40

IMPORTANT The Not Programmed status is used for samples for which:

• A bar code was read, but no programming was found.

• A bar code was not read, and no manual sample programming was

found for that rack and position.

Updated This is the time and date that the sample entry was last updated.

The time and date is displayed in the format selected in System Setup
(12 or 24-hour clock and month/day or day/month).

A13914AF

System Description

Main Screen and Program Structure

Table 1.16 Sample Log Fields (Continued)

Field Description

Status • 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.

1

• If some CC results are still incubating, the sample status shows Removed

when it is first taken off the sample carousel. In this case, the sample is
deleted from the list when it goes to Complete. If it does not go to Complete,
more status strings are added, as applicable. Possible statuses are listed
below:

— Duplicate Sample ID
— Editing Sample

— Programming Conflict

— Barcode ID Too Long
— Invalid Barcode Char(acter)

— Host Query Timeout

• The Status updates when the sample is:

— loaded and an error condition is detected

— removed from the sample carousel
— completed with all its tests

A13914AF

1-41

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.

1-42

2

Select Post Run F10. The Post Run Summary prints automatically.

NOTE

The Post Run Summary may require up to 7 minutes for printing.

A13914AF

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

System Description

Theory of Operation

1

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

Cartridge Chemistry: Calibration Theory

Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries

Ty pe F or m ul a

System Description

1

Nonblanked
Endpoint
Chemistries

Blanked Endpoint
Chemistries

FOR HIGH CALIBRATOR LEVEL:

Reaction ABS = ABS
Reaction ABS = ABS

rep1

+ ABS

rep2

(ABS

rep1

rep2

) × 0.5 = ABS

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

Reaction ABS = ABS
Reaction ABS = ABS
(ABS

rep1

+ ABS

rep2

Cal Factor (Slope) =

Offset = Cal Set Point (hi) - [Cal Factor × ABS

rep1

rep2

) × 0.5 = ABS

Cal Set Point (hi) – Cal Set Point (lo)

avg

ABS

(lo)

avg

(hi) – ABS

(hi)]

avg

avg

(lo)

E014416L.EPS

Sample values are calculated by the following equation:
(Reaction ABS × Cal Factor) + offset = sample value

IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point

and the offset is equal to zero.

FOR HIGH CALIBRATOR LEVEL:

(Reaction ABS - Blank ABS) = Delta ABS
(Reaction ABS - Blank ABS) = Delta ABS
(Delta ABS

+ Delta ABS

rep1

FOR LOW CALIBRATOR LEVEL:

(Reaction ABS - Blank ABS) = Delta ABS
(Reaction ABS - Blank ABS) = Delta ABS
(Delta ABS

+ Delta ABS

rep1

rep1

rep2

) × 0.5 = Delta ABS

rep2

rep1

rep2

) × 0.5 = Delta ABS

rep2

avg

avg

(hi)

(lo)

A13914AF

Cal Factor (Slope) =

Offset = Cal Set Point (hi) - [Cal Factor × Delta ABS

Cal Set Point (hi) – Cal Set Point (lo)

Delta ABS

(hi) – Delta ABS

avg

avg

(hi)]

(lo)

avg

E014417L.EPS

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

E007123L.EPS

Blank Correction Factor =

Total Reaction Volume

Blank Volume

=

Volume of Total Reagent and Sample at Reaction Read

Volume of Reagent(s) (and Sample) at Blank Read

Cartridge Chemistry: Calibration Theory

Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)

Ty pe F or m ul a

Blanked Endpoint
Chemistries
(with Volume
Correction)

FOR HIGH CALIBRATOR LEVEL:

[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS
(Delta ABS

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS
[Reaction ABS - (Blank ABS × Blank Correction Factor)] = Delta ABS
(Delta ABS

Cal Factor (Slope) =

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

avg

(lo)

Cal Set Point (hi) – Cal Set Point (lo)

Delta ABS

(hi) – Delta ABS

avg

(lo)

avg

E014417L.EPS

rep1

rep2

rep1

rep2

Offset = Cal Set Point (hi) - [Cal Factor × Delta ABS

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.

avg

(hi)]

1-46

A13914AF

System Description

Cartridge Chemistry: Calibration Theory

Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)

Ty pe F or m ul a

1

Nonblanked Rate
Chemistries

FOR HIGH CALIBRATOR LEVEL:

Reaction Rate = Rate
Reaction Rate = Rate
(Rate

rep1

+ Rate

rep2

rep1

rep2

) × 0.5 = Rate

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

Reaction Rate = Rate
Reaction Rate = Rate
(Rate

rep1

+ Rate

rep2

Cal Factor (Slope) =

Offset = Cal Set Point (hi) - [Cal Factor × Rate

rep1

rep2

) × 0.5 = Rate

avg

(lo)

Cal Set Point (hi) – Cal Set Point (lo)

Rate

(hi) – Rate

avg

avg

(hi)]

avg

(lo)

E014418L.EPS

Sample values are calculated by the following equation:
(Reaction Rate × Cal Factor) + offset = sample value

IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point

and the offset is equal to zero.

A13914AF

1-47

System Description

Cartridge Chemistry: Calibration Theory

Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)

Ty pe F or m ul a

Blanked Rate
Chemistries

FOR HIGH CALIBRATOR LEVEL:

(Reaction Rate - Blank Rate) = Delta Rate
(Reaction Rate - Blank Rate) = Delta Rate
(Delta Rate

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

rep1

rep2

(hi)

avg

FOR LOW CALIBRATOR LEVEL:

(Reaction Rate - Blank Rate) = Delta Rate
(Reaction Rate - Blank Rate) = Delta Rate
(Delta Rate

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

Offset = Cal Set Point (hi) - [Cal Factor × Delta Rate

rep1

rep2

(lo)

avg

(hi)]

avg

Sample values are calculated by the following equation:
[(Reaction Rate - Blank Rate) × Cal Factor] + offset = sample value

IMPORTANT For single point linear calibration, the low calibrator is a fixed zero point

and the offset is equal to zero.

1-48

A13914AF

System Description

E007123L.EPS

Blank Correction Factor =

Total Reaction Volume

Blank Volume

=

Volume of Total Reagent and Sample at Reaction Read

Volume of Reagent(s) (and Sample) at Blank Read

Cartridge Chemistry: Calibration Theory

Table 1.17 Calculation of Calibration Factors for Endpoint and Rate Chemistries (Continued)

Ty pe F or m ul a

1

Blanked Rate
Chemistries
(with Volume
Correction)

FOR HIGH CALIBRATOR LEVEL:

[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate
(Delta Rate

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate
[Reaction Rate - (Blank Rate × Blank Correction Factor)] = Delta Rate
(Delta Rate

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

avg

(lo)

rep1

rep2

rep1

rep2

Offset = Cal Set Point (hi) - [Cal Factor × Delta Rate

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.

avg

(hi)]

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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

a, b, c = parameters which define the nonlinear elements of the math model

= calculated response for a zero sample

=scale parameter

1-50

A13914AF

System Description

Cartridge Chemistry: Calibration Theory

Table 1.18 Math Models for Non-Linear Chemistries

Ty pe F or m ul a

Model #1 Math Model #1 is the four-parameter log-logit function most commonly used with

reagents that use antibodies.

Sample values are determined using the calculated curve parameters and the math
model. Values may be calculated directly as this model can be solved for concentration.

Model #2 Math Model #2 is a five-parameter logit function.

E014421L.EPS

1

This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.

Model #3 Math Model #3 is a five-parameter exponential function.

This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.

Models #4
through #7

Model #8 Math Model #8 is an alternative to model #2, the five-parameter logit function.

These Models are reserved for future development.

This function cannot be solved directly for concentration. The instrument uses an
iterative method to determine the sample value.

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1-51

System Description

E014478L.EPS

Cartridge Chemistry: Calibration Theory

Table 1.18 Math Models for Non-Linear Chemistries (Continued)

Ty pe F or m ul a

Model #9 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)

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Quadratic
(POLY2)

Lorentz

Double Inflection
Model DP4

R =

1 +

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K

c1

a

1

+

1 +

K

c2

a

2

concconc

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1-52

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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.

System Description

Modular Chemistry: Calibration Theory

1

Modular Chemistry: Calibration Theory

Calibration Theory

Modular chemistries are calibrated using two to three levels of calibrator (chemistry dependent).
Four replicates per level are assayed. Data from two middle replicates of each level is used to set the
system response. The highest and lowest replicates are discarded. Error checks are performed on
the two middle replicates to verify successful calibration.

Calibration Error Detection

The analog signals generated by the calibrator measurements are converted to digital form. The
resulting ADC values are compared to pre-programmed back-to-back, span and range limits to
determine the calibration acceptability.

Modular Chemistries (MC)

The UniCel DxC contains seven chemistry modules (see chart below), each of which is used in the
determination of eleven modular chemistries (MC), as follows.

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1-53

System Description

Cartridge Chemistry: Principles of Measurement

Table 1.19 Methodology and Modules Used with Modular Chemistries

Chemistry Methodology Module

Sodium Ion selective electrode (ISE) ISE Flow cell

Potassium Ion selective electrode ISE Flow cell

Chloride Ion selective electrode ISE Flow cell

Carbon Dioxide pH electrode ISE Flow cell

Calcium Ion selective electrode ISE Flow cell

Urea Nitrogen

Phosphorus

Creatinine

Glucose Oxygen sensor Glucose

To t al P r o t ei n

Albumin

a. DxC 800 only.

a

a

a

a

a

Conductivity electrode Urea Nitrogen

Colorimetric Phosphorus

Colorimetric Creatinine

Colorimetric Total Protein

Colorimetric 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)

1-54

c = constituent concentration (M)

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Routine Operation Overview

Daily Procedure

The following procedure shows an example of daily work flow using the UniCel DxC Synchron
Clinical System.

CHAPTER 2

Preparing Samples for Analysis

IMPORTANT

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.

This procedure assumes that the initial system setup has been completed.

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8

If the system has gone into Standby, press RUN on the system.

9

Review the patient results.

2-1

Preparing Samples for Analysis

Preparing Samples for Analysis

10

Return to Step 7 if more samples need to be run.

11

The system automatically returns to Standby when all testing is completed.

Preparing Samples for Analysis

Minimum Sample Volume

A minimum sample volume is required to run tests. To determine what volume of sample to use,
refer to the Synchron LX/UniCel DxC Clinical Systems Sample Template.

Sample Racks

Sample racks accept the following tube and cup sizes:

Table 2.1 Sample Racks

13 × 75 12 × 75 mm tubes

16 × 75 16 × 75 mm tubes

13 × 100 13 × 100 mm tubes

16 × 100 16 × 100 mm tubes

IMPORTANT

Rack Accepts these cups and tubes

13 × 75 mm tubes

0.5 mL cups

2.0 mL cups

0.5 mL cups

2.0 mL cups
Capillary collection tubes (use with the capillary tube adapter)

16.5 × 92 mm tubes
Beckman Coulter 0.5 mL Cup Insert (PN 467406)

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

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0.5 mL 2.0 mL

Preparing Samples for Analysis

Sample Preparation by Container Type

Table 2.2 shows how to prepare different sample containers.

Table 2.2 Preparation of Sample Containers

If running a sample from a... Then...

Primary Tube • Use the Synchron LX/UniCel DxC Clinical Systems Sample Template to

determine adequate sample volume.

• Remove the cap if not using CTS.

• For CTS systems, remove the cap, if not a validated closed tube.

Secondary Tube • Determine sufficient volume.

• Check for fibrin or other materials resulting from storage.

2

Beckman Coulter Synchron
Microtube

Sample Cup

0.5 mL
(PN 651412)

2.0 mL
(PN 652730 or

81902)

BD Microtainer • Place Microtainer in adapter (PN 472987).

0.5 mL Cup Insert
(PN 467406) (reusable)

• 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.

• 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.

(Refer to figure to the right.)

• Make sure there are no bubbles in sample.

• A "reserved rack" must be used.

• Place the metal Cup Insert into a 16 × 100 mm rack.

• Insert a 0.5 mL cup into the Cup Insert.

• A "reserved rack" must be used.

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2-3

Preparing Samples for Analysis

2

3

4

4

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1

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

1. 14 mm (0.55 inch) Minimum

2. Label Placement Area

3. 20 mm (0.78 inch) Minimum

4. 7.5 Degree Maximum

2-4

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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 Tubes Validated for Cap Piercing Size

1-Blade Thick CTS Becton Dickinson VACUTAINER with HEMOGARD 13 × 75mm

1-Blade Narrow CTS Sarstedt S-Monovette

a. This tube requires a special 5.5 mL rack (PN A18642).

Preparing Samples for Analysis

Preparing Samples for Analysis

13 × 100 mm
16 × 100 mm

Greiner VACUETTE 13 × 75mm

13 × 100 mm

75 × 15 mm
92 × 15 mm

2

a

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.

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• 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.

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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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.

Preparing Samples for Analysis

How to Use Reserved Racks

2

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

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.

Even if the Auto Serum Index feature is enabled, no serum indices are run for the pre-treated

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These features can only be modified when the system is in Standby, Stopped, Startup, Instrument
Down, or Homing state.

2-7

Preparing Samples for Analysis

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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

4

Type the rack numbers to assign as reserved racks in the HbA1c and IBCT fields.

AND/OR
Type the rack numbers to assign as reserved racks.

5

Select OK to assign the racks.

2-8

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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)

CHAPTER 3

System Setup Options

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3-1

System Setup Options

Password Setup

Figure 3.2 Setup Screen (scrolled to the bottom)

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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

3-2

• Rgts/Cal, Within-Lot Calibration

• Rgts/Cal, Enzyme Validator

• QC

• Setup

• Utils, Clear Event Log

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