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

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A13914-AB

October 2005

UniCel® DxC Synchron

Clinical Systems

Instructions For Use

For In Vitro Diagnostic Use Only

This manual is intended for

UniCel UniCel® DxC 800

DxC 600

REPEC Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue Galway, Ireland 353 91 774068

BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA 92835 U.S.A.

CHAPTER 1 General Information.......................................................................................... 1-1

General Information....................................................................................... 1-1

Manual Conventions...................................................................................... 1-2

How to Use this Manual ................................................................................ 1-3

Summary of Hazards ..................................................................................... 1-4

Summary of Precautions................................................................................ 1-7

Symbols and Labels..................................................................................... 1-12

CHAPTER 2 System Description........................................................................................... 2-1

System Description........................................................................................ 2-1

Operational Conditions.................................................................................. 2-2

System Components ...................................................................................... 2-5

Sample Handling System............................................................................... 2-7

Modular Chemistry (MC) System ............................................................... 2-13

Cartridge Chemistry (CC) Reagent Handling System................................. 2-18

Cuvette Reaction System............................................................................. 2-21

Hydropneumatic System.............................................................................. 2-24

Operation and Control Components ............................................................ 2-26

Main Operator Screen and Program Structure............................................. 2-27

Theory of Operation..................................................................................... 2-37

Cartridge Chemistry: Calibration Theory.................................................... 2-38

Modular Chemistry: Calibration Theory ..................................................... 2-49

Cartridge Chemistry: Principles of Measurement ....................................... 2-50

CHAPTER 3 Preparing Samples for Analysis........................................................................ 3-1

Routine Operation Overview......................................................................... 3-1

Sample Programming and Processing ........................................................... 3-2

How to Use Reserved Racks.......................................................................... 3-8

CHAPTER 4 System Setup Options....................................................................................... 4-1

Overview........................................................................................................ 4-1

Password Setup.............................................................................................. 4-3

Auto Serum Index/ORDAC........................................................................... 4-5

Configuring the Chemistry Menu.................................................................. 4-7

Setting the Default Sample Type................................................................. 4-15

Date/Time Setup .......................................................................................... 4-16

Demographics Setup.................................................................................... 4-17

Patient Results – Immediate Reporting Setup ............................................. 4-18

Panels........................................................................................................... 4-19

Replicates..................................................................................................... 4-20

Report Setup ................................................................................................ 4-21

Reportable Ranges Setup............................................................................. 4-22

Reference/Critical Ranges Setup ................................................................. 4-24

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Sample Comments Setup............................................................................. 4-25

Special Calculations Definition ................................................................... 4-26

Timed Urine and Creatinine Clearance Results........................................... 4-29

Setup Summary............................................................................................ 4-30

Units/Precision Setup................................................................................... 4-31

User Defined Chemistries Setup.................................................................. 4-32

Bar Code Setup ............................................................................................ 4-33

Maximum Sample Program Age ................................................................. 4-34

Reserved Racks/Obstruct Detect ................................................................. 4-35

Disable Service Monitor .............................................................................. 4-36

Host Communications.................................................................................. 4-37

Language/Keyboard Setup........................................................................... 4-38

Printer Setup ................................................................................................ 4-39

Service Setup ............................................................................................... 4-40

System Configuration .................................................................................. 4-41

Version Upgrade.......................................................................................... 4-42

Status Alarm/Annunciator ........................................................................... 4-43

Chemistry Update ........................................................................................ 4-44

Auto Generation of Control ......................................................................... 4-45

CHAPTER 5 Reagent Load/Calibration................................................................................. 5-1

Reagent Load ................................................................................................. 5-1

System Calibration.......................................................................................... 5-13

System Calibration Introduction.................................................................. 5-13

Loading a Calibrator Diskette...................................................................... 5-14

Calibrator Assignment ................................................................................. 5-15

Calibration Status......................................................................................... 5-16

Reagent and Calibration Status Warnings ................................................... 5-17

Requesting a Calibration.............................................................................. 5-18

Calibration Failure Messages....................................................................... 5-20

Within-Lot Calibration ................................................................................ 5-21

Enzyme Validator ........................................................................................ 5-25

Calibration Override .................................................................................... 5-26

Chemistry Bypass ........................................................................................ 5-27

Extending Calibration Time......................................................................... 5-28

Calibration Acceptance Limits .................................................................... 5-29

Calibrator Set Point Modifications .............................................................. 5-30

Slope Offset Adjustment.............................................................................. 5-32

Reprint Calibration Reports......................................................................... 5-34

CHAPTER 6 Quality Control ................................................................................................. 6-1

Quality Control .............................................................................................. 6-1

Defining a Control ......................................................................................... 6-4

Control ID Assignments ................................................................................ 6-8

Running Control Samples.............................................................................. 6-9

Editing a Control Definition ........................................................................ 6-11

Reviewing a Control Definition................................................................... 6-12

Deleting a Control........................................................................................ 6-13

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Printing QC Ranges ..................................................................................... 6-14

QC File List ................................................................................................. 6-15

QC Summary ............................................................................................... 6-16

QC Chart (Levey-Jennings)......................................................................... 6-17

QC Log ........................................................................................................ 6-19

Archive QC.................................................................................................. 6-22

Restore and Review Archived Data............................................................. 6-24

CHAPTER 7 Sample Programming ....................................................................................... 7-1

Overview........................................................................................................ 7-1

Prior to Programming .................................................................................... 7-2

Identifying Samples ....................................................................................... 7-4

Selecting Tests ............................................................................................... 7-7

Programming Functions................................................................................. 7-8

Batch Programming ....................................................................................... 7-9

CHAPTER 8 Results Recall ................................................................................................... 8-1

Overview........................................................................................................ 8-1

Recalling Results by Sample ID .................................................................... 8-2

Recalling Results by Rack and Position ........................................................ 8-3

Recalling Results by Patient ID..................................................................... 8-5

Recalling Results by Run Date/Time............................................................. 8-6

Displaying Recalled Results .......................................................................... 8-7

Critical Result Rerun Editing......................................................................... 8-8

Printing Recalled Results............................................................................. 8-10

Sending Results to the Host......................................................................... 8-11

Absorbance Versus Time............................................................................. 8-12

Statistical Summary Report ......................................................................... 8-13

CHAPTER 9 User Defined Reagents ..................................................................................... 9-1

Overview........................................................................................................ 9-1

Requirements and Precautions....................................................................... 9-2

User-Defined Reagent Setup ......................................................................... 9-4

Chemistry Parameters.................................................................................... 9-5

Processing Parameters ................................................................................. 9-10

Error Detection Limits................................................................................. 9-16

Wavelength Selection .................................................................................. 9-18

Determination of Extinction Coefficients.................................................... 9-20

Exit Check Criteria ...................................................................................... 9-21

User Defined Reagent Removal .................................................................. 9-23

CHAPTER 10 Maintenance.................................................................................................... 10-1

Maintenance Overview................................................................................... 10-1

Overview...................................................................................................... 10-1

Electronic Maintenance Log........................................................................ 10-4

Weekly Maintenance ................................................................................... 10-8

Monthly Maintenance................................................................................ 10-18

Two-Month Maintenance .......................................................................... 10-37

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Three-Month Maintenance ........................................................................ 10-44

Four-Month Maintenance .......................................................................... 10-50

Six-Month Maintenance ............................................................................ 10-55

As-Needed/As-Required Maintenance ...................................................... 10-68

CTS Wick Replacement Procedure ......................................................... 10-121

CHAPTER 11 System Status and Commands........................................................................ 11-1

Overview...................................................................................................... 11-1

System Status.................................................................................................. 11-2

Status Summary ........................................................................................... 11-2

Status-Cycle Count ...................................................................................... 11-4

Temperatures ............................................................................................... 11-5

Power Subsystems ....................................................................................... 11-6

Hydropneumatics Subsystem....................................................................... 11-7

ICS/Smart Modules...................................................................................... 11-8

Cuvette Water Blank Status......................................................................... 11-9

CTS Tracking............................................................................................. 11-10

Instrument Commands.................................................................................. 11-11

Instrument Commands Summary .............................................................. 11-11

Home.......................................................................................................... 11-12

Pause .......................................................................................................... 11-13

Stop Print ................................................................................................... 11-15

Shutdown ................................................................................................... 11-16

System Power On/Boot.............................................................................. 11-19

Pause/Resume Waste B ............................................................................. 11-21

Enable/Disable Modules............................................................................ 11-22

Unload All.................................................................................................. 11-24

CHAPTER 12 Utilities............................................................................................................ 12-1

Overview...................................................................................................... 12-1

Prime............................................................................................................ 12-2

Maintenance................................................................................................. 12-7

Event Log..................................................................................................... 12-8

Alignment/Diagnostics/PVTs .................................................................... 12-14

Metering..................................................................................................... 12-15

Modem....................................................................................................... 12-16

Backup/Restore.......................................................................................... 12-17

Touch Screen Calibration .......................................................................... 12-20

CHAPTER 13 Troubleshooting Calibration and Result Errors.............................................. 13-1

Troubleshooting Calibration Errors................................................................ 13-1

Calibration Errors ........................................................................................ 13-1

MC Calibration ............................................................................................ 13-3

Linear Calibration........................................................................................ 13-8

Non-Linear and Multipoint Calibrations ................................................... 13-12

Troubleshooting Result Errors...................................................................... 13-17

Result Errors .............................................................................................. 13-17

Error Codes and Definitions ......................................................................... 13-18

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GLOSSARY

INDEX

Result Errors and Codes ............................................................................ 13-18

Error Code – Definitions............................................................................ 13-21

Common Error Messages and Corrective Actions .................................... 13-29

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Table of Contents UniCel DxC Systems Instructions For Use A13914 Page 6 of 6 October 2005

General Information

Intended Use

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

Scope of This Manual

This manual covers basic operating instructions and maintenance guidelines for UniCel DxC 600/800 Systems. Detailed operation, maintenance, and troubleshooting instructions are not included in this manual. In addition, medical and diagnostic interpretation, or the clinical significance of chemistries or assays are not discussed. Refer to the reference materials below for detailed information.

CHAPTER 1 General Information

General Information

Intended Use

Reference Manuals

Other manuals that accompany the system include:

• the UniCel DxC Synchron Clinical Systems Reference Manual which contains detailed system description, comprehensive operating instructions, theory of operation, system calibration, and programming procedures, and quality control information for the UniCel DxC Systems.

• the Synchron Clinical Systems Chemistry Information Manual which contains specific chemistry information for the full range of analytes available on the UniCel DxC and Synchron LX Systems.

• the UniCel DxC Synchron Clinical Systems Host Interface Specifications.

• the Synchron Clinical Systems Performance Verification Manual which will help you integrate the new UniCel DxC System into your daily laboratory routine.

• the UniCel DxC 600/800 Synchron Clinical System Operator Tips which provide additional information about your system, including screen names for general chemistries and Immunoassays.

• the Synchron LX®/UniCel DxC Clinical Systems Sample Template.

UniCel DxC Systems Instructions For Use A13914 General Information October 2005 Page 1-1

Manual Conventions

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

Table 1.1 Conventions Used in this Manual

Convention Description

Icon buttons and

Icon buttons and dialog box buttons are written in bold.

Dialog box buttons

Example:

Select the Samples icon.

Function buttons Function buttons are written in bold with the corresponding

function key in square brackets ([ ]).

Example:

Select Print [F10].

Command buttons (buttons with names

Buttons with names are bold and enclosed in angle brackets

< >. on a screen) or <↑> <↓>

Example:

Select <Cancel>. Instrument buttons Buttons on an instrument are in bold. May be all upper case or

initial caps.

Example:

Press the STOP button. Keyboard keys Keyboard keys are written in bold and enclosed in square

brackets [ ].

Examples:

[X], [→], or [Tab] [Enter] Options button An Options button is a triangle enclosed in angle brackets < >.

Example:

Select the Options button <▼>. Text field Names in the text fields are bold followed by the word "field".

Example:

Type in the Patient ID in the Patient ID field. [Alt + X] Combination keys are written in bold and enclosed by square

brackets ([ ]) with a plus (+) sign between each key.

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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 table which presents a procedure, process, or description.

Procedure Tables

Procedure tables are the most common type of table in this manual. They list each step of a procedure by number with the corresponding action that is to be performed.

Occasionally, a decision must be made at a step within a procedure. A smaller decision table is then presented which describes the variable conditions in the left column and the appropriate action for each condition in the right column.

How to Use this Manual

Manual Format

Example of Procedure Table

The following table is an example of a procedure table that contains a decision table.

Step Action

1Select Rerun [F6]. 2

To enter... type...

individual Sample IDs, the Sample IDs for rerun in the Sample

a range of Sample IDs, the Sample ID at the beginning of the

3 Select a button from the bottom of the dialog box.

Read the decision table as a complete sentence, using the first heading to introduce the condition and the second heading to introduce the action. Step 2 of the table is read:

To enter individual Sample IDs, type the Sample IDs for rerun in the Sample IDs field.

IDs field.

range in the Range field.

To enter a range of Sample IDs, type the Sample ID at the beginning of the range in the Range field.

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Summary of Hazards

Introduction

Summary of Hazards

Introduction

This section summarizes the hazards associated with the DxC System. Individual hazards associated with a specific procedure in this manual are included in Warning or Caution boxes within the procedures for that task. Please read this section and the following Summary of Precautions before operating the system.

Bar Code Reader Hazards

Do not tamper with or remove the housing of any bar code reader because of the laserbased nature of the readers and the potential hazard of looking directly at laser light. When the instrument is running, homing, or in diagnostics, the laser may be ON. At all other times the laser is OFF.

Biohazardous Materials Hazards

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. Do not select <OK> when the cover is removed. This will move the Cap Piercer Carriage up and cause a pinching hazard.

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 a floor.

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.

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.

Flammable Materials Hazards

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

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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

When lowering the ISE module, keep fingers clear to avoid a pinching hazard.

Moving Parts Hazards

Do not place hands near any moving parts while the system is in 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 Antifoam Material Safety Data Sheets (MSDS) for additional information.

Hazardous/Biohazardous Substances Hazards

Summary of Hazards

Power Cord Hazards

Only use a three-pronged power cord to connect the instrument to a matching threewire grounded outlet. Do not use an adapter to connect the power plug to a twopronged outlet.

Service Procedures Hazards

Disconnect the power cord when performing service procedures such as replacing electronic or mechanical components.

The reagents and other chemical preparations used with the system will not normally cause adverse reactions; however, those persons with sensitive skin should wear protective rubber gloves before attempting to work with those substances.

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Summary of Hazards

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. Use water to wash reagent from skin. Refer to the related Material Safety Data Sheets (MSDS) for additional information.

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.

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-6 October 2005

Summary of Precautions

Introduction

This section summarizes the precautions that should be taken when operating the DxC System. Individual precautions associated with a specific procedure in this manual are included in Caution boxes within the procedures for that task. Please read this section and the preceding Summary of Hazards before operating the system.

AccuSense™ Glucose Sensor Precautions

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

Air Filter Cleaning Precautions

Summary of Precautions

Introduction

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. Once removed from refrigerated storage, these calibrators should remain at room temperature. The calibrator once opened 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.

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™ (P/N 448163 or P/N 448162) on Synchron Systems or the use of Synchron Microtubes (P/N 756776) on Array systems may result in short sampling, incorrect results, and/or sample probe damage.

UniCel DxC Systems Instructions For Use A13914 General Information October 2005 Page 1-7

Summary of Precautions

Biohazard Precautions

• 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. This includes but may not be limited to wearing gloves and eye shields, and washing hands after working on contaminated portions of the system.

Blood Barrier Collection Tube Precautions

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

BUNm/UREAm Electrode Precautions

Loosen the BUNm/UREAm electrode retainer nut, approximately one-half turn, and withdraw electrode slightly before removing the stir bar and make sure the BUNm/ UREAm electrode is slightly withdrawn before reinstalling the stir bar. This prevents possible damage to the delicate electrode tip. After the stir bar is reinstalled, tighten the retainer nut to prevent leakage.

CC Subsystems Priming Precautions

If any two of the CC Subsystem items are selected, all three will prime automatically. Check to make certain that all three areas are ready to be primed if any two are selected.

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.

CTS (Closed Tube Sampling) Cap Piercer Precautions

Do not use the Cap Piercer with foil-capped tubes. This will give level sense errors.

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-8 October 2005

CTS Tracking Loss Precautions

For systems with 1-Blade Thick CTS, if there is an unusual loss of network communication, then a message tells you that if you move a tube to a different instrument, remove its cap.

• 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.

• You will be notified 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) Hazards

To prevent damage due to electrical static discharge (ESD), always wear the wrist ground strap when cleaning the probes, Flow Cell, ISE Drain or CC sample, Glass Cuvettes and reagent mixers; removing, installing or flushing the Flow Cell Electrodes; cleaning the EIC Ports; bleaching CO2 Alkaline Buffer Reagent Straw and

Line; removing the CO2 Measuring Electrode Membrane; replacing EIC Quad-Ring, Ratio Pump Quad-Rings, Alkaline Buffer Peri-Pump Tubing or Sample and Reagent

Syringes.

Summary of Precautions

CTS Tracking Loss Precautions

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.

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.

ISE Reagent Precautions

Failure to operate the system with sufficient ISE reagent will result in erroneous chemistry results. In some cases, results will be obtained without reagents. Therefore, before starting any run, verify 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.

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Summary of Precautions

Narrow Margin Bar Code Precautions

The sample bar code reader on the DxC 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.

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 even in ratio pump failure.

Reagent Volume Precautions

Check reagent volumes before starting a run. Failure to operate with sufficient reagent will result in erroneous chemistry results. In some cases, results will be obtained without proper amounts of reagents in the modules. Therefore, before starting any run, verify 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, 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 call Beckman Coulter Technical Support.

Note: Oil on a cap is normal.

Reuse of Sample ID Precautions

If your LIS or normal workflow requires the reuse of sample IDs, the sample programming should be cleared from the DxC at a time interval that is less than the shortest time of sample ID reuse. Failure to heed this warning will result in new requests being merged with tests from incomplete samples that previously used that ID.

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Sample Bar Code Reader Precautions

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

Sample Syringe Replacement Precautions

When installing the syringes, do not mix the two different syringe sizes. The MC and CC sample syringes (100 µL) are located on the back wall of the instrument. The CC reagent syringe (500 µL) is located on the right side of the instrument.

Samples NOT received by Host Precautions

Do not clear samples until results are received at the host and 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.

Samples Use Precautions

Do not use the same sample run on an DxC system for analysis of analytes for which a small quantity of carryover could greatly increase the results (for example, TBhCG).

Sample Bar Code Reader Precautions

Summary of Precautions

If your system has a Closed Tube Sampling (CTS) option, Do not run samples in cups on top of a sample tube. This would give motion errors. As an alternative, put the sample in a nesting cup on a tube in a reserved rack.

System Backup Precautions

After inserting a diskette into the floppy disk drive, selecting <OK> when prompted will prepare the floppy disk 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 will lead to system errors.

System Restore Precautions

System Parameter and Alignment data can be restored from the backup floppy disks 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 will minimize the potential for chloride drift due to matrix effects of urine samples.

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Symbols and Labels

Introduction

Symbols and Labels

Introduction

The following is a list of symbols and labels used on the DxC Systems. You will find them affixed to the appropriate components of the system, as described briefly below.

Instrument Power Switch, ON

This symbol located on the main power switch indicates that the analyzer power is ON when this portion of the switch is in the down position.

Instrument Power Switch, OFF

This symbol, also located on the main power switch, indicates that the analyzer power is OFF when this side of the switch is in the down position.

Instrument or Printer Power Switch, ON

This symbol is located on the analyzer and printer power switch. When the portion of the switch with this symbol on it is in the down position, power to the monitor or printer is ON.

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.

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-12 October 2005

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

Symbols and Labels

CPU Power OFF Switch

This symbol is found above the connection between the computer and the keyboard.

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.

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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.

CAUTION

This symbol indicates a caution message and is followed by an explanation or other symbols that define the caution (see examples below).

CAUTION Operate with All Covers in Place

This symbol is located on top of the work surface cover and the cover of an optional Cap Piercer. It indicates a caution to operate only with all covers in place to reduce risk of personal injury or biohazard.

456161-B

General Biohazard

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

CAUTION

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

A011459L.EPS

A011460L.EPS

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-14 October 2005

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.

Class II Laser Caution Warning

A label reading, "CAUTION. LASER LIGHT - DO NOT STARE INTO BEAM. 670nm - 1mW CLASS II LASER PRODUCT." is placed near any opening through which a bar code reading beam will emit. Do not stare into laser light beam.

Symbols and Labels

Laser Bar Code Caution

Laser

A label reading, "AVOID EXPOSURE. LASER LIGHT IS EMITTED FROM THIS APERTURE." is placed near any opening through which a bar code reading beam emits. Avoid exposure to laser light emitted.

Sharp Objects Caution

A label reading, "CAUTION. SHARP OBJECTS - REFER SERVICING AND MAINTENANCE TO QUALIFIED SERVICE PERSONNEL." is found on top of the optional cap piercing hardware which is located underneath the removable cover of the cap piercing tower.

CAUTION

SHARP OBJECTS - REFER

SERVICING AND MAINTENANCE TO

QUALIFIED SERVICE PERSONNEL.

A012936L.EPS

UniCel DxC Systems Instructions For Use A13914 General Information October 2005 Page 1-15

Symbols and Labels

ISE Cover Caution

A label reading, "THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION." is placed on top of the ISE module frame under the ISE cover to indicate that the ISE cover should remain in place during system operation.

THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION.

471830-AA

Moving Parts Caution

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

A012937L.EPS

CAUTION PARTS MOVE AUTOMATICALLY

MC Door Caution

A label reading, "THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION." is found on the top edge of the left hand (MC reagent) door and indicates that the door should remain closed during system operation.

THIS DOOR SHOULD REMAIN CLOSED DURING SYSTEM OPERATION.

471831-AA

Read Manual Caution

A label reading, "CAUTION - READ MANUAL BEFORE OPERATING." is found on the hydropneumatics behind the center door and recommends the operator read the manuals before operating the system.

A015047L.EPS

CAUTION - READ MANUAL

BEFORE OPERATING

ATTENTION - CONSULTER LA NOTICE

AVANT DE FAIRE FONCTIONNER.

270-455774-A

A012939L.EPS

A012938L.EPS

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-16 October 2005

Rack Loading Label

This label is found to the right of the Run and Priority Load buttons and indicates the correct position of a rack for placement into the autoloader.

Laser Certification Label

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

Symbols and Labels

Rack Loading Label

Ethernet/Serial Port Label

This label is found on the right side of the system and identifies connections for the Ethernet and serial ports.

PRODUCT COMPLIES WITH 21 CFR CHAPTER I, SUBCHAPTER J

MANUFACTURED DECEMBER 2004

LABEL P/N 448229 AB

BECKMAN COULTER, INC

SERIAL PORT

MADE IN U.S.A. MARCA REG

ETHERNET

A011540L.EPS

A012942L.EPS

UniCel DxC Systems Instructions For Use A13914 General Information October 2005 Page 1-17

Symbols and Labels

Fluid Interface Label

This label is found on the center, back, bottom edge of the system. It identifies inlet and outlet ports on the system.

136

Recycling Label

This symbol is required in accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive of the European Union. The presence of this marking on the product indicates:

1. the device was put on the European Market after August 13, 2005 and

2. the device is not be disposed via the municipal waste collection system of any

WASTE B

SENSOR

WASTE B OUTLET

D. I. WATER INLET

MAX. PRESS. 100 PSI (689 kPa)

WASTE OUTLET

member state of the European Union.

137128

D.I. FIBER

A012943L.EPS

A016608L.EPS

It is very important that customers understand and follow all laws regarding the proper decontamination and safe disposal of electrical equipment. For Beckman Coulter products bearing 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.

General Information UniCel DxC Systems Instructions For Use A13914 Page 1-18 October 2005

System Description

Introduction

The following chapter briefly 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 2 System Description

System Description

Introduction

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-1

Operational Conditions

Shipping Damage

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

Refer to the following table.

Table 2.1 Installation Requirements

Item Requirement

Installed by The DxC system is installed completely by Beckman

Coulter

Installation Category II

Clearances

The system requires the following clearances.

Table 2.2 System Clearances

Area Affected Clearance Needed

Left Side Minimum of 6 inches (15.2 cm) clearance or 12 inches

Right Side Minimum of 18 inches (45.7 cm) clearance when monitor

Back Zero inches. The venting design of the system allows for

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

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

Sunlight and Drafts

(30.5 cm) to access smart modules.

on swing arm is in use.

"0 inch" clearance at the back.

system.

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

Drain

The system should be located near a sink or floor drain to accommodate the waste effluent at a minimum rate of 6 liters/hour (16 liters/hour continuous flow).

The drain must not be placed any higher than 36 inches (91.4 cm) above the floor.

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-2 October 2005

Power Requirements

Table 2.3 Power Requirements

Operating range 180–264 V AC, RMS

Frequency 47–63 Hz (50/60 Hz nominal) BTU generated DxC 600: 7,200 BTU/hour at nominal (estimated)

Power connector 20 A current rating. Nema L6-20R twistlock Uninterrupted power supply Refer to UPS manufacturer’s literature for

Item Requirement

220 V AC nominal, approximately 15 A at low line, exclusive of power on surge

DxC 800: 7,500 BTU/hour at nominal (estimated) DxC PC: 979 BTU/hour

specifications

Operational Conditions

Power Requirements

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 220V AC, 50/60 Hz.

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

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 2.4 Temperature, Humidity and Elevation

Item Specification

Environment Indoor use only Ambient temperature +18°C to +32°C

NOTICE

CAUTION

Warm-up time 30 minutes (time to reach operating temperature) Relative humidity 20–85% relative, non-condensing Elevation Up to 1,280 m (4,200 ft.)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-3

Operational Conditions

Water Requirements

Table 2.5 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 quality NCCLS Type II deionized water, except for total

bacteria count < 10 cfu/mL Water pressure Deionized water entering the system must be 30–90

psig.

Other System Specifications for IEC-1010 Compliance

Table 2.6 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 Maximum Leakage Current DxC 600: 222 µA at 240V, 50Hz

DxC 800: 240 µA at 240V, 50Hz

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-4 October 2005

System Components

DxC Systems

A UniCel DxC System can be divided into the following components:

• Sample Handling Components

• Modular Chemistry System

• Cartridge Chemistry Reagent Handling System

• Hydropneumatic System

• Operation and Control Components

A Closed Tube Sampling System has optional components listed below:

System Components

DxC Systems

• Large Particle Immuno Assay Module (LPIA)

• Closed Tube Sampling (CTS)

1. Modular Chemistry (MC) Section

2. Cartridge Chemistry (CC) Portion

3. Autoloader

4. Reaction Carousel

5. Dual Reagent Carousel

6. Operator Console

A015900P.EPS

Figure 2.1 UniCel DxC 600 Analyzer

Equivalent to Near Infrared Particle Immuno Assay (NIPIA).

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-5

System Components

DxC Systems

Figure 2.2 UniCel DxC 800 Analyzer

A015901P.EPS

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-6 October 2005

Sample Handling System

Introduction

The Sample Handling system is composed of the following components:

• Sample racks

• Autoloader/Offload track

• Priority load position

• Shuttle

• Bar code reader

• Cap piercer assembly (optional)

• Sample Carousel

• Sample probe/mixer assemblies

• Wash cup assemblies

• Obstruction detection assemblies

Sample Handling System

Introduction

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.

Sample Racks

A sample rack is a high-strength, plastic, centrifugable holder designed to house up to four samples. There are four sizes of racks with each size capable of holding one length/width combination of primary sample tubes in addition to accepting sample cups. (Refer to Figure 2.3.)

Sample racks accept the following tube and cup sizes:

Table 2.7 Sample Racks

NOTICE Adapters are provided to adapt various sized sample tubes (secondary tubes) to the short racks. These adaptors must only be used in racks designated as reserved. The reserved rack feature is described in CHAPTER 4,

Options.

System Setup

Rack Accepts These Cups and Tubes

13 × 75 12 × 75 mm tubes

13 × 75 mm tubes

0.5 mL cups

2.0 mL cups

(1 of 2)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-7

Sample Handling System

Rack ID Labels

Table 2.7 Sample Racks, continued

Rack Accepts These Cups and Tubes

16 × 75 16 × 75 mm tubes 13 × 100 13 × 100 mm tubes

16 × 100 16 × 100 mm tubes

0.5 mL cups

2.0 mL cups Capillary collection tubes (use with the capillary tube adapter) Beckman Coulter Microtubes™

16 × 92 mm tubes

16.5 × 100 mm tubes Beckman Coulter 0.5 mL Cup Insert (P/N 476399)

Rack ID Labels

Sheets of bar-coded rack ID labels are supplied with the system. They can be applied as shown in Figure 2.3.

(2 of 2)

1. Numeric Rack ID number

2. Rack size label

3. Bar coded rack ID label

Figure 2.3 Rack

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-8 October 2005

Autoloader/Offload Track

When viewed from the front of the system, the autoloader is on the left and holds up to 25 sample racks in preparation for presentation to the DxC 800 system. The DxC 600 system has room to load a maximum of 14 racks. (Refer to Figure 2.4.)

There is also space for 25 sample racks in the offload track as they are removed from the Sample Carousel upon completion. Combined, these two components allow for over one hour of uninterrupted sample processing, with no operator intervention involved.

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

NOTICE

Sample Handling System

Autoloader/Offload Track

2 3 4 8765

1. Pushers

2. Autoloader

3. Run button

4. Priority load button

Figure 2.4 Sample Loading Area

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 2.4.)

A015902P.EPS

5. Sample gate

6. Shuttle

7. Offload track

8. Stop button

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-9

Sample Handling System

Priority Load Button

Typically, rack placement and removal is under microprocessor control. The operator may choose to use the reserved positions by pressing the PRIORITY LOAD button and placing the priority rack in the space provided by the system. (Refer to Figure 2.4.) The rack will load 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 2.4.)

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. (Refer to Figure 2.4.)

Shuttle

The Shuttle moves the rack from the gate area onto the Sample Carousel. (Refer to

Figure 2.4.)

Bar Code Reader (Sample)

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 "Symbols and Labels of the CAUTION labels for the bar code reader.

CAUTION

" in CHAPTER 1, General Information, for a description

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-10 October 2005

1-Blade Thick CTS (Closed Tube Sampling) Cap Piercer Assembly (optional)

CAUTION

This Cap Piercer contains a razor sharp blade assembly.

CAUTION

Do NOT use this Cap Piercer assembly with foil-capped tubes. This would give level sense errors.

This optional 1-Blade Thick CTS Cap Piercer assembly pierces thick-stoppered 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 2.8 Tubes Validated for Closed Tube Sampling

Sample Handling System

Cap Piercer

Tube Type Tube Size

Configuration

1-Blade Thick CTS

Becton Dickinson VACUTAINER®a with HEMOGARD™

Greiner VACUETTE

®a

13 × 75 mm 13 × 100 mm 16 × 100 mm

13 × 75 mm 13 × 100 mm

Sarstedt S-Monovette

®ab

75 × 15 mm

92 × 15 mm

All trademarks are the property of their respective owners.

This tube requires a special 5.5 mL rack (P/N A18642).

Refer to "Symbols and Labels" in CHAPTER 1, General Information, for a description of the CAUTION labels for the Cap Piercer.

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-11

Sample Handling System

Sample Carousel

The ten-rack position Sample Carousel is a motor-driven turntable. (Refer to Figure

2.5.) Under normal operation, eight of the Sample Carousel positions are available for

routine processing and two positions are reserved for priority racks.

1. Liquid level sense assembly

2. Sample probe (CC)

3. Collar wash

4. Sample Carousel

Figure 2.5 Sample Carousel Area

A015903P.EPS

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-12 October 2005

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.

Reagent Storage Area

Modular Chemistry (MC) System

Introduction

The reagent containers used to supply the modular chemistries are located behind the left front door of the system. The only exception is the CO2 alkaline buffer which is

located on the ISE module.

A015906P.EPS

1. Bar code reader (hand held)

2. Reagent storage area

Figure 2.6 Modular Chemistry Reagent Storage Area

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-13

Modular Chemistry (MC) System

Reagent Bar Code Reader (Modular)

Behind the left side door of the system there is a hand-held bar code reader. (Refer to

Figure 2.6.)

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.

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

54321

1. Solenoid valve (example)

2. Cylinder 1

3. Cylinder 2

Figure 2.7 DxC 800 Ratio Pump

A015904P.EPS

4. Cylinder 3

5. Outlet line (example)

6. Inlet line (example)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-14 October 2005

Electrolyte Injection Cup (EIC)

The EIC mixes the sample and buffer prior to delivery of the sample (now diluted) to the flow cell.

Modular Chemistry (MC) System

Electrolyte Injection Cup (EIC)

1. Waste outlet

2. Flow Cell outlet

3. Buffer inlet

4. Reference inlet

5. DI H

Figure 2.8 Electrolyte Injection Cup

O inlet

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-15

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. (Refer to Figure 2.9.)

1. Inlet port

2. CL electrode

3. K electrode

4. CO

5. CO

reference electrode

electrode

Figure 2.9 Flow Cell

6. Exit port for waste (large tube)

7. Exit port for internal reference

8. Na reference electrode

9. Na electrode

10. Ca electrode

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-16 October 2005

Chemistry Reaction Modules (Basic Components)

Each of the six Chemistry Reaction Modules have similarities in their design. These common elements are described below. (Refer to Figure 2.10.) Unique design elements of the modules are described under the specific module headings later in this section.

Chemistry Reaction Modules (Basic Components)

Modular Chemistry (MC) System

1. Circuit board (behind protective shield)

2. Reaction cup

3. Reaction cup housing

4. Mixer motor assembly

5. Reagent pump assembly

A015905P.EPS

Figure 2.10 Basic Components of Modules (Ex: Albumin)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-17

Cartridge Chemistry (CC) Reagent Handling System

Introduction

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.

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.

1. A compartment

2. B compartment

3. C compartment

Figure 2.11 CC Reagent Cartridge

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-18 October 2005

Reagent Carousel

The Reagent Carousel Compartment provides an on-instrument storage area for the individual reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time. (Refer to Figure 2.12.)

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

Cartridge Chemistry (CC) Reagent Handling System

1 2

Reagent Carousel

1. Top positions 31–59

2. Top Bar Code Reader

3. Bottom positions 1–30

4. Bottom Bar Code Reader

Figure 2.12 CC Dual Carousels with Two Bar Code Readers

Reagent Bar Code Reader (CC)

The Bar Code Reader, (refer to Figure 2.12), 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.

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 2.13

A007408P.EPS

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-19

Cartridge Chemistry (CC) Reagent Handling System

Reagent Mixer Assembly

1. Reagent Mixer

2. CC Reagent Probe A

3. CC Reagent Probe B

4. Collar Wash

A015908P.EPS

Figure 2.13 CC Reagent Probe Area

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 2.13.)

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. (Refer to Figure 2.13.)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-20 October 2005

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.

Cuvette Reaction System

Introduction

A description of each component is presented in the following paragraphs.

Reaction Carousel

The reaction carousel assembly, (refer to Figure 2.14), 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.)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-21

Cuvette Reaction System

Photometer Assembly

1. LPIA module

2. Reaction carousel

3. Photometer

A015909P.EPS

Figure 2.14 Reaction Carousel Area (Typical – Cover Removed)

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

2.14.)

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) or NIPIA (Near-Infrared Particle Immuno Assay) Module (optional)

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 2.14.) It has two printed circuit boards, an LED (light-emitting diode) and a photodetector. Communication with the system software is through fiber optic cables.

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-22 October 2005

Cuvette Wash Station

The Cuvette Wash Station, (refer to Figure 2.15), 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.

Cuvette Reaction System

Cuvette Wash Station

1. Probe #1

2. Probe #2

3. Probe #3

Figure 2.15 Cuvette Wash Station

4. Probe #4

5. Wash station

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-23

Hydropneumatic System

Introduction

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 2.16 and Figure 2.17.) 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.

Function

A016497P.EPS

1. Wash concentrate solution

2. No foam reagent

3. DI water reservoir

4. Dilute wash solution reservoir

5. Wash concentrate reservoir

6. Auto-Gloss

Figure 2.16 DxC 800 Hydropneumatics (right side)

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

• Vacuum

• Compressed air

• Diluted wash solution

• Deionized water

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-24 October 2005

Hydropneumatic System

567

A015911P.EPS

Function

1. Waste exit

2. Waste B exit

3. DI water inlet On/Off

4. DI water reservoir

5. Vacuum accumulator

6. Waste B canister

7. Waste canister

Figure 2.17 DxC 800 Hydropneumatics (left side)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-25

Operation and Control Components

Operator Controls

Operation and Control Components

Operator Controls

The operator interfaces with various control devices such as the keyboard, monitor and push-button 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 2.4) are used to start the process, to prioritize a sample run, or to stop the process under certain conditions as described in Table 2.9 below.

Table 2.9 DxC Push-Button Controls

Push-Button

Primary Function

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

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-26 October 2005

Main Operator Screen and Program Structure

Main Operator Screen

DxC System operating and programming functions are initiated from the main operator screen at the DxC analyzer (refer to Figure 2.18). In addition, the screen provides status information to help determine the present state of the system.

Main Operator Screen and Program Structure

Main Operator Screen

CTS

1. CTS Indicator

2. Host Indicator

3. System Status Indicator

4. Function Selection Icons

5. Sample Status Icons

6. Sample Status Icon Legend

Figure 2.18 UniCel DxC 800 Main Operator Screen

E016482S.EPS

Accessing the Help System

Help is available online in six supported languages (the default is English). To reach the on-line Help system, select the Question Mark icon ( ) on the right side of the

Function Selection Icon menu. The system will offer three options:

• Install an On-Line Instructions For Use manual (IFU)

• View the installed On-Line Instructions For Use manual

• View the License Agreement

When you access the On-Line Instructions For Use manual screen, the currently loaded language manual version will be show in the Choose a Language dropdown field. To view the IFU Manual in that language, press (on the touch screen) or select (with the mouse) the <View Manual> button. The first page of the IFU Manual will appear.

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-27

Main Operator Screen and Program Structure

Printing Data From a Screen

To load an alternate language, select the desired language from the Choose a Language dropdown list and select the <Install Manual> button. You can then view the IFU Manual in the selected language as described in the preceding paragraph.

To view the License Agreement, simply select the <License> button on the screen.

Printing Data From a Screen

Many screens contain data that may be printed by selecting Print [F10]. Pressing the [Control] and [Print Screen] key simultaneously on the keyboard will also cause the current screen to print, regardless of whether the Print [F10] option is available.

Status Functions

The following Table depicts the status information available from the operator screens of the DxC analyzer.

Table 2.10 Main Operator Screen Status Functions

Status Indicator Status Description

CTS This indicator (refer to item 1 on Figure 2.18) appears in the blue

bar at the top left side of the Operator screens when the Closed Tube Sampling (CTS) option is installed. When "CTS" appears, Closed Tube Sampling is enabled. When CTS appears within the

international "No" symbol ( ), the feature 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 4, System Setup Options.

NOTICE CTS is an optional feature of the system, which allows the system to pierce primary sample tubes. The operator will only be offered the enable/disable CTS option if a CTS assembly is installed, otherwise that selection will be grayed out on the setup screen. The default for CTS sampling is "OFF."

Host This indicator (refer to item 2 on Figure 2.18) appears on the blue

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

(1 of 2)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-28 October 2005

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Table 2.10 Main Operator Screen Status Functions, continued

Status Indicator Status Description

System Status This indicator appears just below the Function Selection Icons

on the left side of the Operator screens (refer to item 3 on Figure

2.18). It shows the current state of the system: either Running or

Standby. 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.

(2 of 2)

Sample Status Indicators

When monitoring sample status, a sample status icon (refer to item 5 on Figure 2.22) appears in front of listed sample. Samples are listed in a rack status box directly below the sample status icon legend (6). The sample statuses shown are as follows:

Table 2.11 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.

Function Selection 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 (refer to item 4 on Figure

2.18). The overall program structure is shown in beginning on the following page.

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-29

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Main

Samples

F1 Results F2 Unload F8 Log F9 Pre Run F10 Post Run

F2 Demog

F3 Options

F4 Batch

F5 Control

F6 Rerun

F7 Clear

F1 Sample F2 Edit F3 Urine F10 Next

Clear OK Smp ID Only

F3 Options F5 Control F6 Remove F8 Rgt Cart F9 Cancel F10 Save

Select All Batch Cancel

Sample IDs Rack(s)/Position(s) Date/Time (From/To) OK Cancel

System Replicates Sample Replicate Serum Index Off-line Dilution Factor Manual ORDAC Test Replicates OK Cancel

Rack End

System Replicates Sample Replicate Serum Index Off-line Dilution Factor Manual ORDAC Test Replicates OK Cancel

F3 Options F7 Rgt Cart F8 Remove F9 Cancel F10 Save

F1 Clear F9 Cancel F10 Program

Sample ID(s) From/To Rack(s)/Position(s) Date/Time (From/To) Status Print Display Cancel

F1 Disk F2 Recall F3 ABS F4 Edit F6 Host F7 Print F8 Prev F9 Next F10 Done

Results

F8 Racks

F9 List

F10 Next

Sample ID(s) Rack(s)/Pos(s) Patient ID Multi-Sample Report Run Date/Time (From/To) F1 Results F7 Sum F8 Host F10 Print

Figure 2.19 Program Structure (Main, Samples and Results)

Sample Required In Progress Complete Incomplete Rerun Manual Assign Cancel

Plot Ta bl e Both Print Next Prev Done

E007323L.EPS

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-30 October 2005

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Rgts/Cal

F1 Load F2 Params F3 No Load F4 Cal F5 List F6 Options

F7 Assign F8 No Cal F9 Sort (CC List) F10 Print

F1 Review

F1 Clear F10 Done

Load calibrator diskette Calibrator acceptance limits Modify set points Slope/Offset adjustment Within lot calibration Enzyme Validator Calibration override Bypass chemistry Extend calibration time Print cal report Cancel

Avail Racks Next Prev Close

Position Chemistry Tests Left Days Left Cal Time Left OK

F2 Control ID F3 Delete F9 Print F10 Done

Current Cal Report Previous Cal Report(s)

F2 Define

F3 Delete

F4 List

F5 Log

F6 Summary

F7 Chart

F8 Archive

F10 Print

F1 Chems F2 Control ID F3 Delete F10 Done

F1 All Chem F2 All File F10 Done

QC Date Range OK Cancel F8 Inter-Lab F9 Print F10 Done

QC Date Range OK Cancel F1 Chems F2 Filenum F7 Prev F8 Next F9 Print F10 Done

Option 1 Archive to Disk Option 2 Review Disk Cancel

QC Date Range OK Cancel F1 Chem F2 Rgt Lot F3 Delete F4 Action F9 Print F10 Done

E007324L.EPS

Figure 2.20 Program Structure (Rgts/Cal and QC)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-31

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Setup 1. Auto Serum Index/ORDAC F1 Restore

2. Chem Config/Sample Type

3. Date/Time

4. Demographics Setup

5. Immediate Report

6. Panels

7. Replicates

8. Report Setup

9. Reportable Ranges

10. Reference/Critical Ranges

F10 Done

F1 Date F2 Time F3 Restore F10 Done

F1 Restore F10 Done

MC STAT Host/Printer MC ALL Host/Printer Immediate Report of Reruns OK Cancel

F1 Define F2 Delete F3 Default F10 Done

F1 Restore F10 Done

Report Header Patient Format Control Format Inter-Laboratory Information Print Patient and Control Report F1 Restore F10 Done

Define/Edit Cancel

Define/Edit Clear Ranges

F1 Chems F2 UDR F3 Define F4 Clear F5 Insert F6 Delete F10 Done

F1 Restore F8 Prev F9 Next F10 Done

F1 Delete F2 Clear All F3 Default F8 Previous F9 Next F10 Done

Serum CSF Plasma Random Urine Timed Urine Blood Other

E007409L.EPS

11. Sample Comments

Summary by Sample Type Ranges Summary Cancel

F10 Done

Figure 2.21 Program Structure (Setup – Page 1)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-32 October 2005

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Setup, continued

12. Special Calculations F1 View

13. Setup Summary

14. Units/Precision

15. User-Defined Chemistries

16. Barcode

17. Reserved Racks/Obstruct Detect

18. Disable Service Monitor

19. External Water Monitor

20. Host Communications

F2 Define F3 Delete F10 Done

F10 Done

F1 Restore F10 Done

F1 Define F2 Delete F4 Config F9 Print F10 Done

Code 39 Parameters Codabar Parameters Interleaved 2 of 5 Parameters Code 128 Barcode Mode Rack/Position Mode Maximum Sample Program Age (Days/Hours) F10 Done

1-Blade Thick CTS Reserved Racks 75mm Racks 100mm Racks Obstruction Detection Reserved Racks for HbA1c Reserved Racks for IBCT Restore Defaults OK Cancel

F1 Restore F2 Diag F10 Done

F1 Restore F9 Cancel F10 Done

F1 Restore F2 Host Com F10 Done

21. Language/Keyboard

22. Printer Setup

23. Service Setup

24. System Configuration

25. Version Upgrade

26. Status Alarm/Annunciator

27. Chem Update

28. Password Setup

29. Auto Generation of Control

Language Keyboard OK Cancel

Restore Default Printer Type Paper Size OK Cancel

Insert CD

Alarm Test OK Cancel

System

Media

Control Sample Multiple Cartridges F10 Done

DxC

CD Diskette

E007326L.EPS

Figure 2.22 Program Structure (Setup – Page 1 continued and Page 2)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-33

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Utils 1. Prime F1 Prime

F2 CC

F3 Hydro

F4 MC

Start Prime Stop Prime F10 Exit

All CC Subsystems All Hydropneumatic Subsystems All MC Subsystems Prime DxC Prime CTA Prime CTA Auto-Gloss CTS Auto-Gloss CTS Blade Wash

Reagent Delivery Subsystem Sample Delivery Subsystem Cuvette Wash

Fill Canisters and reservoirs CC Drain waste sump CC Drain waste B sump Drain gravity drain sump

Cup Selection: ALBm (DxC 800 only) CREm (DxC 800 only) GLUCm (DxC 600 only) PHOSm (DxC 800 only) TPm (DxC 800 only) BUNm (DxC 800 only) Prime Cup(s) with: Reagent DI Water Sample Delivery Subsystem ISE All Electrolyte Buffer Electrolyte Reference EIC Wash ISE CO2 Alkaline Buffer Reference and Acid

1. 1-Blade Thick CTS Blade Replacement

2. Maintenance

2. Cartridge Chemistry Probe Cleaning

3. ISE Service

4. Cup Maintenance

5. Hydropneumatic Maintenance

6. Wash All Cuvettes

7. Syringe Rod Replacement

8. CUPs Lamp/Sensor Calibration

9. CC Reagent Wash All Cuvettes

10. Clean Flow Cell and Cups F1 Action F2 Log F10 Exit

Figure 2.23 Program Structure (Utils)

1. Albumin (DxC 800 only)

2. BUNm (DxC 800 only)

3. Creatinine (DxC 800 only)

4. Glucose (DxC 600 only)

5. Phosphorus (DxC 800 only)

6. Total Protein (DxC 800 only) Prime20 Prime5 Drain Rinse Cancel

E007327L.EPS

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-34 October 2005

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Utils, continued

3. Event Log Display

4. Diagnostics

5. Alignment

Copy Time Clear Print Done

1. Chemistry Errors

2. Motion Errors

3. Status Monitor Errors

4. Other Instrument Errors

5. Instrument Events

6. LIS Comm. Errors

7. Other Console Errors

8. Input Device Events

9. Other Console Events

10. Sample Processing Events

11. Deleted Results

Functional Areas

Sub-functional Areas

Test Selection F10 Exit

Align All Reaction Carousel Cuvette Wash Station Reagent Carousel Sample Carousel Sample Rack Handling Sample Rack Barcode Reader Cap Piercer CC Sample Crane or Probe CC Sample Crane Smart Module (B2) MC Sample Crane or Probe MC Sample Crane Smart Module (52) Reagent A Crane or Probe Reagent A Crane Smart Module (C2) Reagent B Crane or Probe Reagent B Crane Smart Module (C3) CC Sample Mixer Crane or Body CC Sample Mixer Smart Module (B3) Reagent Mixer Crane or Body Reagent Mixer Smart Module (C1) CTA Assemblies Procedure Selection - Based on Functional Area selected F10 Exit

Sample System Reagent System Reaction System Hydropneumatic System ISE Module System Modular Cup Chemistry Module Valve and Fluidics

Based on Functional Area selected

E007328L.EPS

Figure 2.24 Program Structure (Utils – continued)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-35

Main Operator Screen and Program Structure

Function Selection Icons and Program Structure

Utils, continued

Status

Instr Cmd

Help

6. PVT

7. Modem

8. Backup/Restore

9. Metering

10. Touch Screen Calibration

F1 Summary F2 Count F3 Temp F4 Power F5 Hydro F6 Smrt Mdl F7 Cuv Stat F8 CTS F10 Print

1. Home

2. Pause

3. Stop Print

4. Shutdown

5. Pause Waste B

6. Resume Waste B

7. Enable/Disable Modules

8. Unload All

Choose a Language: English (default) Italian Spanish French German Japanese Install Manual View Manual License

Performance Verification Tests Sub-Functional Area Test Selection - Based on Functional Area Selected F10 Exit

System Parameters Alignment Data Files Backup Restore Cancel

F1 Disk F2 Replen F3 Report F4 Off F5 Modem F9 Cancel F10 Done

E007329L.EPS

Figure 2.25 Program Structure (Utils – continued 2, Status, Instr Cmd, and Help)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-36 October 2005

Theory of Operation

Introduction

The UniCel DxC Synchron Clinical Systems are microprocessor-controlled, random access clinical analyzers capable of processing a wide variety of operator-selected chemistries in a single run.

Cartridge Chemistries (CC)

The optical system of the DxC enables rate, endpoint, and nonlinear analyses to be performed simultaneously. These analyses are referred to as cartridge chemistries because the reagents are stored in cartridges.

Cartridge Chemistry (CC): Sample and Reagent Processing

During operation, a number of events occur simultaneously and are under direct control of the instrument microprocessors.

Theory of Operation

Introduction

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-37

Cartridge Chemistry: Calibration Theory

Introduction

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.

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 will be discarded. The average value of the calibrator replicates is used to determine the calibration factor.

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-38 October 2005

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.

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries

Type Formula

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Nonblanked Endpoint Chemistries

FOR HIGH CALIBRATOR LEVEL:

Reaction ABS = ABS Reaction ABS = ABS (ABS

rep1

+ ABS

rep1 rep2

) × 0.5 = ABS

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

Reaction ABS = ABS Reaction ABS = ABS (ABS

+ ABS

rep1

Cal Factor (Slope) =

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

rep1 rep2

) × 0.5 = ABS

rep2

(lo)

avg

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

ABS

(hi) – ABS

avg

(hi)]

(lo)

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

E014416L.EPS

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(1 of 6)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-39

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries, continued

Type Formula

Blanked Endpoint Chemistries

FOR HIGH CALIBRATOR LEVEL:

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

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

rep1 rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

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

Cal Factor (Slope) =

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

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

Delta ABS

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

rep1 rep2

(hi) – Delta ABS

avg

(lo)

avg

E014417L.EPS

(hi)]

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

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(2 of 6)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-40 October 2005

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries, continued

Type Formula

Blanked Endpoint Chemistries (with Volume Correction)

FOR HIGH CALIBRATOR LEVEL:

Blank Correction Factor =

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

Volume of Total Reagent and Sample at Reaction Read

Blank Volume

Total Reaction Volume

E007123L.EPS

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

rep1

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

(Delta ABS

rep2

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

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

rep1

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

rep2

+ Delta ABS

rep1

) × 0.5 = Delta ABS

rep2

avg

(lo)

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

E014417L.EPS

(hi)]

avg

(lo)

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

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(3 of 6)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-41

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries, continued

Type Formula

Nonblanked Rate Chemistries

FOR HIGH CALIBRATOR LEVEL:

Reaction Rate = Rate Reaction Rate = Rate (Rate

rep1

+ Rate

rep1 rep2

) × 0.5 = Rate

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

Reaction Rate = Rate Reaction Rate = Rate (Rate

+ Rate

rep1

Cal Factor (Slope) =

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

rep1

rep2

) × 0.5 = Rate

rep2

(lo)

avg

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

Rate

(hi) – Rate

avg

(hi)]

(lo)

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

E014418L.EPS

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(4 of 6)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-42 October 2005

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries, continued

Type Formula

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 avg(hi)

rep2

rep1 rep2

FOR LOW CALIBRATOR LEVEL:

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

Cal Factor (Slope) =

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

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

Delta Rate

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

rep1 rep2

(hi) – Delta Rate

avg

(lo)

avg

(lo)

avg

E014419L.EPS

(hi)]

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

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(5 of 6)

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-43

Cartridge Chemistry: Calibration Theory

Endpoint and First-Order Calibration Formulas

Table 2.12 Calculation of Calibration Factors for Endpoint and Rate

Chemistries, continued

Type Formula

Blanked Rate Chemistries (with Volume Correction)

FOR HIGH CALIBRATOR LEVEL:

Blank Correction Factor =

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

Volume of Total Reagent and Sample at Reaction Read

Blank Volume

Total Reaction Volume

E007123L.EPS

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

rep1

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

(Delta Rate

rep2

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

avg

(hi)

FOR LOW CALIBRATOR LEVEL:

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

rep1

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

rep2

+ Delta Rate

rep1

) × 0.5 = Delta Rate

rep2

avg

(lo)

Cal Factor (Slope) =

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

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

Delta Rate

(hi) – Delta Rate

avg

E014419L.EPS

(hi)]

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

NOTICE For single point linear calibration, the low calibrator is a fixed zero point and the offset is equal to zero.

(lo)

(6 of 6)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-44 October 2005

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.

Cartridge Chemistry: Calibration Theory

Non-Linear Chemistries

• 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

= calculated response for a zero sample

= scale parameter

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

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-45

Cartridge Chemistry: Calibration Theory

Non-Linear Calibration Formulas

Table 2.13 Math Models for Non-Linear Chemistries

Type Formula

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

commonly used with reagents that use antibodies.

R = R0 + K

1 + e

–a–b∗1n(conc)

E014420L.EPS

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.

R = R0 + K

1 + e

–a–b∗1n(conc) – c(conc)

E014421L.EPS

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

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

R = R0 + K

a∗1n(conc) + b∗1n(conc)2 + c∗1n(conc)

E014422L.EPS

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

Models #4

These Models are reserved for future development.

through #7 Model #8 Math Model #8 is an alternative to model #2, the five-parameter logit

function.

E014423L.EPS

R = R0 + K

1 + e

–a–b∗1n(conc)

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

(1 of 2)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-46 October 2005

Cartridge Chemistry: Calibration Theory

Drugs of Abuse Testing (DAT) Chemistries

Table 2.13 Math Models for Non-Linear Chemistries, continued

Type Formula

Model #9 Math Model #9 is an extension to model #1, the four-parameter log-

logit function.

Polynomial Exponential (PXP)

Quadratic (POLY2)

Lorentz

Double Inflection Model DP4

R = R0 + K

1 + c ∗ e

–a–b∗1n(conc)

E014424L.EPS

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.

R = b0 + Pn(x)e Pn(x) = Polynomial of degree N

R = b0 + b1∗(conc) + b2∗(conc)

R = R0 + π {arctan(c∗conc + a) + 2 }

R =

1 +

-a∗(conc)

E014476L.EPS

E014477L.EPS

Conc Conc

1 +

A011537L.EPS

E014478L.EPS

(2 of 2)

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.

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-47

Cartridge Chemistry: Calibration Theory

Enzyme Verification

Enzyme verification is a means of adjusting enzyme chemistry reporting units to IFCC 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 UniCel DxC Systems Instructions For Use A13914 Page 2-48 October 2005

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.

Modular Chemistry: Calibration Theory

Calibration Theory

Table 2.14 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

Conductivity electrode Urea Nitrogen

Colorimetric Phosphorus

Colorimetric Creatinine

Glucose Oxygen sensor Glucose

Total Protein

Albumin

DxC 800 only.

Colorimetric Total Protein

Colorimetric Albumin

UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-49

Cartridge Chemistry: Principles of Measurement

Spectrophotometric Methods

Cartridge Chemistry: Principles of Measurement

Spectrophotometric Methods

Spectrophotometric methods rely on the principle that a sample, such as a patient sample, a control, or a calibrator, when mixed with one or more appropriate chemical reagents, produces a substance that has the ability to absorb light at specific wavelengths. This substance is referred to as a chromophore.

Beer's Law

According to Beer's Law, the amount of light absorbed by the chromophore is proportional to the concentration of the constituent being measured. The system can measure this as an endpoint or a rate of formation.

A = abc

where

A = absorbance of the chromophore a = absorptivity of the absorbing substance at the specific measuring

wavelength(s) b = cuvette light pathlength (cm) c = constituent concentration (M)

System Description UniCel DxC Systems Instructions For Use A13914 Page 2-50 October 2005

CHAPTER 3 Preparing Samples for Analysis

Routine Operation Overview

Daily Procedure

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

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

Step Action

1 If necessary, start the system. 2 Check reagent status. Load reagent as necessary.

NOTICE

Routine Operation Overview

Daily Procedure

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 the RUN button on the system. 6 Check the control results to verify system operation. 7 Program or load patient samples. 8 If the system has gone into Standby, press the RUN button on the system. 9 Review the patient results.

10 Return to Step 7 if more samples need to be run. 11 The system will automatically return to Standby when all testing has been

completed.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-1

Sample Programming and Processing

Introduction

Sample Programming and Processing

Introduction

Sample programming provides the ability to identify samples, select tests to run, describe samples, and designate how to run samples. Samples are programmed through a host computer or Laboratory Information System (LIS or at the analyzer). The minimum information required to save a sample program includes:

• a sample ID or a rack and position assignment

• and one test selection

Test selections are assigned by the use of panels or by the selection of individual tests. Samples may be described and defined through sample type, sample comment, patient ID, and patient demographic functions. A sample can be programmed as a control sample or as a STAT for priority processing. Once programmed, samples are placed on the autoloader for processing.

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. If this warning is not followed, results from the new request will be merged with tests from incomplete samples that previously used that ID.

Program Samples and Controls

Refer to this chapter for Sample information and CHAPTER 6, Quality Control for Control programming information. If auto QC is enabled, reuse the same control ID bar code labels.

CAUTION

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-2 October 2005

Prepare Samples

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 3.1 Sample Racks

13 × 75 12 × 75 mm tubes

Sample Programming and Processing

Rack Accepts these cups and tubes

13 × 75 mm tubes

0.5 mL cups

2.0 mL cups

Prepare Samples

16 × 75 16 × 75 mm tubes 13 × 100 13 × 100 mm tubes

0.5 mL cups

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

16 × 100 16 × 100 mm tubes

16.5 × 92 mm tubes Beckman Coulter 0.5 mL Cup Insert (P/N 476399)

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-3

Sample Programming and Processing

Sample Preparation by Container Type

Table 3.2 shows how to prepare different sample containers.

Table 3.2 Preparation of Sample Containers

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

Primary Tube • Use the sample template in the Appendix to determine

adequate sample volume.

• Remove the stopper.

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

Secondary Tube • Remove the cap.

• Determine sufficient volume.

• Check for fibrin or other materials resulting from storage.

Beckman Coulter Synchron Microtube™

Autoanalyzer Cup

BD Microtainer

0.5 mL 2.0 mL

E014498L.EPS

• Pipette the sample into a Synchron Microtube™.

• Verify there are no bubbles at the bottom of the tube.

• Place into a 13 × 100 "reserved" rack.

• Place the cup into a rack.

• Place in 15 × 85 tube (with sample bar code on tube).

• Verify there are no bubbles in sample.

• If cup is placed in a tube with a Bar Coded label a "reserved rack" must be used.

• Place Microtainer in adapter P/N 472987.

(refer to figure to the right)

• Verify there are no bubbles in sample.

• If cup is placed in a tube with a Bar Coded label a "reserved rack" must be used.

0.5 mL Cup Insert (P/N 476399) (reusable)

• Place the metal Cup Insert into a 16 × 100 mm rack (P/N 471921 – blue or 474463 – purple).

• Insert a 0.5 mL Autoanalyzer cup into the Cup Insert.

• Run in the "reserved rack" mode.

A011538L.EPS

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-4 October 2005

Sample Tubes Validated for CTS

Introduction

Rubber cap 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 safer.

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 reserved rack. Each tube is scanned to determine if it needs piercing. Refer to the table below for validated tubes.

Table 3.3 Tubes Validated for Closed Tube Sampling

Sample Programming and Processing

Sample Tubes Validated for CTS

CTS Configuration Tubes Validated

for Cap Piercing

1-Blade Thick CTS

Becton Dickinson VACUTAINERa

with HEMOGARD

Greiner VACUETTE

Sarstedt S-Monovette

All trademarks are property of their respective owners.

This tube requires a special 5.5 mL rack (P/N A18642).

CAUTION

Before placing validated closed tubes on the UniCel DxC Systems, check the top of the cap for any residual blood. Residual blood can contaminate the sample and affect results. If blood is present, remove it by using a cottontipped 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 call Beckman Coulter Technical Support. Note: Oil on a cap is normal.

®ab

Size

13 × 75mm 13 × 100 mm 16 × 100 mm

13 × 75mm 13 × 100 mm

75 × 15 mm 92 × 15 mm

Reserved Racks for CTS Samples

The Reserved Racks/Obstruct Detect feature allows the user access to the following features:

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.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-5

Sample Programming and Processing

Reserved Racks

The 16 × 100 tubes must be run in a non-reserved 16 × 100 mm rack.

If a sample ID is manually cleared, the CTS tracking information is cleared on that instrument only. If a sample ID is reused and the tube requires piercing, the sample ID must be cleared on the instrument that is loaded first.

Do not clear the Sample ID manually. Before you run a sample whose cap has been pierced, be sure that its sample ID has not been cleared.

• If you clear a sample ID at the Host, the sample ID is NOT cleared in the CTS Tracking database.

• If you were to manually clear the sample ID for a tube, you would also clear the sample ID in the CTS Tracking database. The instrument would think it has a new tube and would pierce its cap again. Follow the steps below to verify sample ID clearing status.

NOTICE

Step Action

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 will be set to its 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.

1 Select the Samples icon from the menu bar. 2 Type in the sample ID. 3 Press [Enter]. 4 Does the sample have its initial program?

If… Then… The sample has its initial

program,

The sample does NOT have its initial program (the ID has been

• Do NOT remove its stopper.

• Run the sample.

• Remove its stopper.

• Run the sample.

cleared),

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-6 October 2005

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 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.

Even if the Auto Serum Index feature is enabled, no serum indices will be run for the pre-treated HbA1c and pre-treated IBCT samples run in these reserved racks.

NOTICE

Sample Programming and Processing

Reserved Racks for HbA1c, or IBCT

The default for each of these features is:

• CTS = OFF,

• Reserved racks = none reserved,

• Obstruction detection = On,

• Reserved racks for HbA1c or IBCT = none reserved.

These features can only be modified when the system is in the Standby or Stopped state.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-7

How to Use Reserved Racks

When NOT to Use a Reserved Rack

How to Use Reserved Racks

When NOT to Use a Reserved Rack

When you do CTS (Closed Tube Sampling) do NOT run a closed tube in a reserved rack.

Recommended Use of Reserved Racks

Green Racks

Series 350–400 to run:

• nesting cups

• capillary collection containers

• Beckman Coulter Microtubes™

Gray Racks

Series 601 to run:

• "Barcoded" Calibrators and Controls

Purple Racks

• Series 401–420 to run HbA1c

• 0.5 mL Cup Insert (P/N 476399)

Brown Racks

• Series 451–499 to run IBCT

Blue Racks

0.5 mL Cup Insert (P/N 476399)

To identify a reserved rack, put a red ® on the top of the rack.

NOTICE

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-8 October 2005

Recommended Use of Reserved Racks

Assigning or Reassigning Reserved Racks

Step Action

1 Select the Setup icon from the menu bar. 2 Select the <Page Down> button on the right side of the screen. 3 Select <17> Reserved Racks/Obstruction Detection.

Type 17 in the Option Number field and press [Enter].

The following screen appears.

How to Use Reserved Racks

E015928S.EPS

Figure 3.1

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.

5Select <OK> to assign the racks.

Select <Cancel> to exit without assigning the racks.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-9

How to Use Reserved Racks

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.

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

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.

1. 14 mm (0.55 inch) Minimum

2. Label Placement Area

3. 20mm (0.78 inch) Minimum

4. 7.5 Degree Maximum

Figure 3.2 Bar Code Label Placement

A014600L.EPS

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-10 October 2005

Processing Bar Coded Samples

Generally, previous sample programming will not need to be cleared before placing a bar coded sample on the instrument. If the lab reuses Sample IDs, previous programming must be cleared.

Step Action

1 Load tubes in a rack with the bar code labels visible through the slot on the

same side of the rack as the rack bar code label.

2 For closed tube sampling systems, check the top of the validated closed

tube for visible blood. If blood is present, clean the rubber stopper with a cotton tipped applicator stick.

For non-CTS Systems or tubes not validated for closed tube sampling, remove the cap.

3 For a Routine Sample or if system is in Standby: Priority samples

should be placed on the autoloader first.

• Place the rack in the autoloader with the rack bar code label to the right and

How to Use Reserved Racks

Processing Bar Coded Samples

•Press RUN.

For a STAT Sample: If the system is running and there are other racks on

the autoloader,

•Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed in front of the other racks.

•Press RUN.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-11

How to Use Reserved Racks

Processing Unreadable Bar Coded Samples

If a sample bar code is unreadable and the LIS needs to be queried, use manual assignment. A manual assignment is rack and position and a Sample ID with no other information. The DxC will query the LIS for tests and demographics.

If... Then...

Individual Samples, • Select the Samples icon from the menu bar,

Several samples in the same rack, • Select the Samples icon from the menu bar,

• Type rack and position,

• Type Sample ID,

• Save [F10].

• Select Rack [F8],

• Select the rack,

• Type Sample ID(s),

• Select <OK>.

Note: If previous programming appears, it may be necessary to clear it.

Processing Samples Manually

Manual programming is used when there is no LIS or the LIS is not available. Samples may or may not be bar coded. The sample is identified by a Sample ID and/ or rack and position. The user selects tests for programming.

The following items require manual programming:

• samples without bar codes

• samples with bar codes and no sample programming

Step Action

1 Select the Samples icon from the menu bar. 2 Before programming, check for previous programming.

•Select Racks [F8].

• Select the rack number and select <OK>.

• If the rack has programming that is no longer required, select Clear [F1].

• Type the Sample IDs into the Sample ID(s) field.

•Select <OK>. A second screen will open. Select <OK> again to clear the data.

3Select Program [F10].

(1 of 2)

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-12 October 2005

Step Action, continued

4 Identify samples using the table below:

If… Then…

How to Use Reserved Racks

Processing Samples Manually

Sample has a readable bar code,

• Type in the sample ID.

• If previous programming appears, it may be necessary to clear it.

• Go to Step 2, or Step 5 if no previous program appeared.

Sample has no bar code or bar code can not be read,

• Type in the sample ID.

• Select the Rack field.

• Type in a rack number that is not programmed.

• Go to Step 5.

5 If the sample is stat, select the STAT check box. 6Select Sample Type and Sample Comment if provided. 7 To enter Demographics, select Demog [F2]. Type in the information

provided and select Next [F10] to return to the Program Sample screen.

8 Select each chemistry and/or select a panel. To access additional

chemistries, use the up and down arrows to move to other pages.

9Select Next [F10].

10 To program additional samples, repeat Steps 2-8. 11 Get the rack(s) listed on the screen and place the samples into assigned

rack positions as shown on the load list.

12 For a Routine Sample or if system is in Standby: Priority samples

should be placed on the autoloader first.

• Place the rack in the autoloader with the rack bar code label to the right and,

•Press RUN.

For a STAT Sample: If the system is running and there are other racks on the autoloader,

•Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed in front of the other racks.

•Press RUN.

(2 of 2)

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-13

How to Use Reserved Racks

Adding Tests or Rerunning a Sample

Step Action

1 Select the Samples icon from the menu bar. 2Select Rerun [F6]. 3 Type the sample ID, rack, or rack and position for rerun. One or more

samples can be programmed to rerun.

4 Select one of the following buttons:

• To add or rerun specific tests press the <Select> button. All previous

programming will be highlighted. Deselect chemistries that are not to be run.

• To rerun all completed tests press the <All> button. Rerun all completed

tests for all requested samples. Go to Step 6.

5Select Next [F10]. 6 For a Routine Sample or if system is in Standby: Priority samples

Clearing Samples

Once the test program has been processed, if all positions were used, the rack is not available for programming again until it has been cleared. Only the programming information is deleted; the results are stored and are accessible through the recall function using the appropriate recall option.

Calibrator IDs or rack/position assignments are not cleared from within Sample Programming. Refer to CHAPTER 5, Reagent Load/Calibration, "Calibrator

Assignment", for information on calibrator identification.

should be placed on the autoloader first.

• Place the rack in the autoloader with the rack bar code label to the right and,

•Press RUN.

For a STAT Sample: If the system is running and there are other racks on the autoloader,

•Press PRIORITY. The rack pusher moves back one space so the STAT rack can be placed in front of the other racks.

•Press RUN.

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

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-14 October 2005

How to Use Reserved Racks

Range of Sample IDs

When to Clear Samples

Samples should be cleared as follows:

If... Then...

Sample programming has been completed. Clear sample programming. A sample ID has to be reused. Clear that sample ID first.

A sample rack can not be programmed due to previous programming. (This occurs when a sample ID does not match, or when a rack number shows previous information.)

Range of Sample IDs

The system retrieves a range of sample IDs in either Alphanumeric or Numeric form. The system automatically selects one of the two, depending on the type of sample ID entered. These same methods of retrieval are used for Load List, Clear Samples and Recall.

Sample IDs containing only Numeric Data:

• Samples are listed in numeric order. For example 1, 2, 3, 4...

• Include leading zeros in the Range field. For example, range 1 thru 1000 would not

include sample 0099, but range 0001 thru 1000 would.

Sample IDs containing only Alpha or Alphanumeric Data:

• Samples are listed in dictionary order. For example A, AB, B...

• Numbers come before letters. For example 1, 900, 1A, A...

Clear that programming.

• Include all characters in the To field. For example, range A thru Z would not

include ZEBRA, but range A thru ZZZZZZZZZZZZZZ would.

NOTICE Do not mix a pure numeric entry with an alphanumeric entry. For example, 0 thorough 1A will delete all numeric.

UniCel DxC Systems Instructions For Use A13914 Preparing Samples for Analysis October 2005 Page 3-15

How to Use Reserved Racks

Procedure for Clearing Samples

Step Action

1 Select the Samples icon from the menu bar. 2Select Clear [F7]. 3 Sample may be cleared by Sample ID(s), Rack/Position, or by Date/Time

created. Type in the specific criteria for deletion.

Clearing Rack/Position does not clear programming for sample(s) programmed in those positions with associated Sample IDs. Sample must still be cleared by Sample ID. However, clearing by Sample ID does clear rack/position in which the Sample ID was located.

NOTICE

Deletion Criteria Procedure for Sample Clearing

Sample ID • Type in the Sample ID(s) to be

cleared. Single and multiple IDs may be cleared. Use a comma (,) to separate a list of IDs.

Range of Sample IDs Refer to "Range of Sample

IDs" in this chapter for

additional information

• Type the first Sample ID in the

Range field.

• Type the last Sample ID in the

Thru field.

Time/Date Programs Created Type the time and date range of

samples to clear.

Rack/Position(s) • Type Rack/Position(s) to be

cleared. Single and multiple racks may be entered.

If only Rack is entered, programming in all positions in that rack will be cleared.

4Select <OK> to continue clearing. A confirmation screen will appear.

Select <Cancel> to retain sample programs.

Preparing Samples for Analysis UniCel DxC Systems Instructions For Use A13914 Page 3-16 October 2005

Overview

Introduction

Overview

Introduction

CHAPTER 4 System Setup Options

This chapter summarizes the 29 System Setup options depicted on the Setup screens shown in Figure 4.1 and Figure 4.2 below:

Figure 4.1 Setup Screen (scrolled to the top)

E015930S.EPS

E015931S.EPS

Figure 4.2 Setup Screen (scrolled to the bottom)

UniCel DxC Systems Instructions For Use A13914 System Setup Options October 2005 Page 4-1

Overview

Introduction

For detailed step-by-step instructions on using the System Setup option, refer to the UniCel DxC Synchron Clinical Systems Reference Manual.

System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-2 October 2005

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

Password Setup

Introduction

• Rgts/Cal, Within-Lot Calibration

• Rgts/Cal, Enzyme Validator

•QC

•Setup

• Utils, Clear Event Log

Defining/Editing Password Setup

To define, edit or delete user names, passwords, privilege levels and accessibility levels, follow the steps below.

Step Action

1 Select the Setup icon from the menu bar. 2Select <28> Password Setup from the Setup screen 3 Type an Administrator password in the Administrator Password dialog

box.

Select <OK>.

Select <Cancel> to return to the System Setup menu.

Note: After a software install, the default password is beckman.

(1 of 2)

UniCel DxC Systems Instructions For Use A13914 System Setup Options October 2005 Page 4-3

Password Setup

Defining/Editing Password Setup

Step Action, continued

4 The Password Setup dialog box shows Page 1 (of 10) of the users with

5 In the Define/Edit Password dialog box, type the information requested.

password security. If necessary, select <Page Down> on the right side of the screen to show the user desired.

Select New [F1] to enter the password setup for a new user.

To edit the password setup for a user, select the user’s password number.

Type the user’s password number in the Numbers field and press [Enter].

Select Define [F2].

NOTICE

Do NOT type beckman in the Password field.

Select Administrator in the Title field to allow the user to modify password setup.

Select Operator in the Title field to NOT allow the user to modify password setup.

Select <OK>.

Select <Cancel> to return to the Password Setup screen.

6 The new or edited user is now in the Password Setup screen in alphabetical

order by last name.

(2 of 2)

Refer to the UniCel DxC Synchron Clinical Systems Reference Manual for additional information on deleting users from the Password List, and enabling and disabling password security for functions.

System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-4 October 2005

Auto Serum Index/ORDAC

Auto ORDAC

Auto ORDAC permits the enabling or disabling of the automatic Overrange Detection and Correction (ORDAC) function for specified chemistries (refer to the Synchron Clinical Systems Chemistry Information Manual for a list of chemistries offering ORDAC). When a chemistry result exceeds the instrument printable range and Auto ORDAC is enabled, the sample will automatically rerun with either:

• a smaller sample size or

• an on-line sample dilution (chemistry dependent).

When Auto ORDAC for Ig-A and Haptoglobin is enabled, the URDAC feature is also enabled. Ig-A and Haptoglobin URDAC is used to analyze samples with concentrations below the analytical range. In this case, the system takes a larger sample volume.

Auto Serum Index/ORDAC

Auto ORDAC

(The manual ORDAC function in Sample Programming is used for samples which are known to exceed the usable range. Chemistries designated with manual ORDAC at the time of programming are run at the ORDAC sample volume.)

From the Setup Screen, select <1> Auto Serum Index/ORDAC to enable or disable ORDAC. The default for Auto ORDAC is OFF.

The Automatic ORDAC screen may be viewed at any time, however the system must be in Standby to modify the ORDAC selection.

NOTICE The analytical ranges for each analyte are system limits found in the respective CISs. These are the ranges that Beckman Coulter has verified can be achieved by the system. There is no flagging associated with values exceeding these limits.

The instrument printable ranges for each analyte are internal system limits. These ranges actually exceed the analytical ranges by a certain limit. This allows for precision variations and still permits a result to print even though it exceeds the analytical range slightly. Results outside this range will be suppressed. The suppressed results will be flagged OIR HI or OIR LO (Out of Instrument Range).

UniCel DxC Systems Instructions For Use A13914 System Setup Options October 2005 Page 4-5

Auto Serum Index/ORDAC

Auto Serum Index

The Auto Serum Index function, when enabled, automatically analyzes every sample for the detection of hemolysis, icerus and lipemia and numeric values (index) for the relative concentrations (range) are included in the report.

The values are printed below the Special Calculations area of a patient report. The values are printed with the test results for a control sample.

Auto Serum Index is intended for sample integrity assessment only; not for patient diagnosis.

For additional information on Serum Indexing, refer to the Synchron Clinical Systems Chemistry Information Manual.

NOTICE When running the system with Automatic Serum Index enabled, remember to manually disable the serum index feature when choosing options to set the replicates. This prevents running indices needlessly.

From the Setup screen, select <1> Auto Serum Index/ORDAC to enable/disable Auto Serum Index.

To enable or disable Auto Serum Index, the system must be in Standby or Stopped.

The default for Auto Serum Index is OFF.

System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-6 October 2005

Configuring the Chemistry Menu

Introduction

• The Chemistry Configuration function accommodates the installation of desired tests from a comprehensive list of available chemistries.

• Of the total tests available, 180 chemistries can be selected and positioned onto the menu at one time and customized to match the test order on the lab request forms.

• Modular chemistries (MC) are permanently configured on the system.

• These chemistries may be relocated on the configuration screen, but not removed.

• BUNm and UREAm both show (DxC 800 only) as available chemistries; only one may be configured at a time. To replace one with the other, overwrite the existing chemistry acronym with the replacement acronym.

• The Chemistry Configuration screen may be viewed at any time, but modifications can only be made when the system status is Standby or Stopped.

Configuring the Chemistry Menu

Introduction

Configuring a Beckman Coulter Chemistry

The chemistry menu, available in sample programming, quality control, panel definition and other screens, is defined by the user. To define Beckman Coulter chemistries, select <2> Chemistry Configuration/Sample Type from the Setup screen. Place the cursor in an open field in the Configuration Chemistry screen and press Chems [F1]. Select the DxC chemistry from the pop-up list.

Configuring a User Defined Chemistry (UDR)

The chemistry menu available in sample programming, quality control, panel definition and other screens is defined by the user. After a User Defined Chemistry (UDR) has been defined by selecting <15> User-Defined Chemistries from the Setup screen, you can Configure the UDR by selecting <2> Chemistry Configuration/ Sample Type from the Setup screen. After the Chemistry Configuration/Sample Type screen appears, selecting UDR [F2] presents a list of all User Defined Chemistries on the system. Refer to CHAPTER 9, User Defined Reagents in this manual for additional information on application of user-defined parameters.

Defining Chemistry Print Name

The Define Print Names function permits definition of the chemistry name that appears on the chartable report. Each chemistry may be given a name of a maximum of 15 characters. To define the chemistry print name, select <2> Chemistry Configuration/Sample Type from the Setup screen. Select Define [F3] from the Configured Chemistry screen to use the Define Print Names screen.

UniCel DxC Systems Instructions For Use A13914 System Setup Options October 2005 Page 4-7

Configuring the Chemistry Menu

Inserting a Chemistry

The Insert function inserts a blank position for adding a chemistry to the menu. After a blank position is inserted, the chemistries following that position will be incremented by one position. If 180 is exceeded, the last one will be dropped. From the Setup screen, select <2> Chemistry Configuration/Sample Type. Refer to UniCel DxC Synchron Clinical Systems Reference Manual for additional information on this procedure.

Deleting a Chemistry

The Delete Chemistry function requires that you first clear the calibration, sample programming and control (QC) information from the instrument before deleting the chemistry from the system. Where it is used, Beckman Coulter recommends that you remove chemistries from the system following the sequence and procedures below to prevent problems with deleting chemistries from the QC definition:

Control samples in the "sample required," "incomplete" or "rerun" status may prevent the removal of the chemistry from the QC definition.

NOTICE

1. Remove the chemistry from Reagent/Calibration (Example: DIG)

Step Action

1 Select the Rgts/Cal icon from the menu bar. 2 Ensure the cal status of the chemistry DIG is not "Requested." To cancel a

calibration request:

• Select the position for the appropriate requested and assigned chemistry to be canceled.

•Select No Cal [F8] to cancel the calibration request. Chemistries currently selected may be canceled only if the calibration is not yet in progress.

3 Remove calibrator assignments. To clear calibrator bar code ID and/or rack

and position:

•Select Assign [F7].

•Select <Next> or <Prev> to locate the calibrator of interest.

• Select the Calibrator Name options button <▼> at the top of the Assign Barcode/Rack dialog box to view the List of Calibrators.

• Clear the fields by selecting the Calibrator ID, Rack and Position fields for each level of calibrator and pressing the [Delete] key on the keyboard.

•Select <Close> to exit and save information.

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System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-8 October 2005

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

Specifications and Main Features

Frequently Asked Questions

User Manual

A13914-AB

Instructions For Use

Table of Contents

General Information

Intended Use

Scope of This Manual

CHAPTER 1 General Information

Reference Manuals

Manual Conventions

Manual Conventions

Table 1.1 Conventions Used in this Manual

How to Use this Manual

Manual Format

Procedure Tables

Example of Procedure Table

Summary of Hazards

Introduction

Bar Code Reader Hazards

Biohazardous Materials Hazards

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

CTS Auto-Gloss Handling Hazards

Electric Shock Hazards

Electrical Ground Hazards

Flammable Materials Hazards

Hazardous/Biohazardous Substances Hazards

ISE Module Hazards

Moving Parts Hazards

No Foam Reagent Pressurization Hazard

Power Cord Hazards

Service Procedures Hazards

Sodium Azide Preservative Hazards

System Operations and Specifications Hazards

Waste B Disposal Hazards/Biohazards

Summary of Precautions

Introduction

AccuSense™ Glucose Sensor Precautions

Air Filter Cleaning Precautions

Alkaline Buffer Stability Precautions

Aqueous Calibrator Precautions

Bar Code Label Precautions

Beckman Coulter Microtube™ Precautions

Biohazard Precautions

Blood Barrier Collection Tube Precautions

BUNm/UREAm Electrode Precautions

CC Subsystems Priming Precautions

CO2 Membrane Replacement Precautions

Covers, Doors and Shields Precautions

CTS (Closed Tube Sampling) Cap Piercer Precautions

CTS Tracking Loss Precautions

Diethylamine HCL and the Calcium ISE Precautions

Electrostatic Discharge (ESD) Hazards

Environmental Conditions Precautions

Fibrin Clots Precautions

ISE Reagent Precautions

MC Reagent Stir Bar Precautions

Narrow Margin Bar Code Precautions

Racks Replacement Precautions

Ratio Pump Quad-Ring Replacement Precautions

Reagent Volume Precautions

Residual Blood Contamination Precautions

Reuse of Sample ID Precautions

Sample Bar Code Reader Precautions

Sample Syringe Replacement Precautions

Samples NOT received by Host Precautions

Samples Use Precautions

System Backup Precautions

System Configuration Change Precautions

System Restore Precautions

Urine Sample Precautions

Symbols and Labels

Introduction

Instrument Power Switch, ON

Instrument Power Switch, OFF

Instrument or Printer Power Switch, ON

Monitor Switch, ON/OFF

CPU Power OFF Switch