Beckman Coulter UniCel DxC 600i User guide

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Page 1

Instructions For Use

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

UniCel DxC 600i Synchron Access Clinical Systems

For In Vitro Diagnostic Use

A93695AC March 2014

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Instructions For Use

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

Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda Estr dos Romeiros, 220 - Galpao G3 - Km 38.5 06501-001 - Sao Paulo - SP - Brasil CNPJ: 42.160.812/0001-44

製造販売元 : ベックマン･コールター株式会社東京都江東区有明三丁目5番7号 TOC 有明ウエストタワー

贝克曼库尔特有限公司，美国加利福尼亚州，Brea 市，S. Kraemer 大街 250 号，邮编：92821 电话：(001) 714-993-5321

UniCel DxC 600i Synchron Access Clinical Systems

PN A93695AC (March 2014)

Trademarks

Beckman Coulter, the Beckman Coulter logo, Access, Synchron and UniCel are trademarks of Beckman Coulter, Inc. and are registered in the USPTO. All other trademarks are the property of their respective owners.

Find us on the World Wide Web at:

www.beckmancoulter.com

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Revision History

This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released.

Initial Issue, A24644AA, 10/05

Software version 1.4

A24644AB, 6/07

Software version 2.0

A24644AC, 2/08

Software version 3.0

A24644AD, 12/08

Software version 4.0

A93695AA, 10/10

Software version 5.0

A93695AB, 10/12

Software version 5.0

A93695AC, 03/14

Changes:

Software version 5.4 Removed references to discontinued CX and LX products.

CHAPTER 1, System Description:

• Added QSD 'Insufficient reagent dispensed' to Table 1.18 Access Codes Converted to DxC Codes

for DxC 600i Reporting.

CHAPTER 2, Pre-Test Activities:

• Information was updated for sample containers in Table 2.1 DxC 600i Sample Containers in

table rows marked 'Used in reserved racks' and 'If running Pediatric samples requiring both DxC and Access chemistries'.

• Updated 'Load or Unload MC Reagents' procedure and added the 'Refill the No Foam Container' procedure to 'Check and Load Supplies at DxC Analyzer' section.

CHAPTER 3, System Calibration and CHAPTER 4, Sample Programming and Processing:

• Updated notes in ‘Calibrate Access Chemistries (Assays)’ and ‘Access: Small Sample Volume

Assays’ sections: “For Access 2 Total BhCG...”

CHAPTER 5, Post-Test Activities:

• Added Extended Shutdown information to 'Power Down the DxC Analyzer' and ‘Power Down

the Access Analyzer’ sections.

• Updated the ‘Shutdown’ and 'Restart the DxC 600i System' procedures.

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Revision History

CHAPTER 6, Maintenance Procedures:

• Updated the 'Electronic Maintenance Tabs and Tasks' for Weekly, Monthly, Three-Month, and

• Added Tecan syringe replacement details to the 'Replace CTA Syringes' procedure in 'CTA

• Added note to alignment procedures: “Beckman Coulter recommends that you backup data

Appendix A, Supplementary DxC 600i Information:

• Updated the Program Structure diagrams.

• Updated notes in Mode A and Mode B columns in Tables A.2, A.3, A.6, A.7, A.8, and A.9 in the

Six-Month Maintenance.

Maintenance (yearly)'.

after every alignment procedure.”

Independent Operating Modes section: “For Access 2 Total BhCG...”

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Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate instrument. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your Beckman Coulter representative.

Introduction

This safety notice summarizes information basic to the safe operation of the UniCel DxC 600i System described in this manual. All safety instructions should be read and understood before installation, operation, maintenance, or repair of this product. Observance of safety precautions will also help to avoid actions that could damage or adversely affect the performance of this product.

Safety During Installation and/or Maintenance

This product is designed to be installed by a Beckman Coulter Field Service representative. Installation by anyone other than authorized Beckman Coulter personnel invalidates any warranty covering the instrument.

Safety Notice

Any servicing of this equipment that requires removal of any covers can expose parts which involve the risk of electric shock or personal injury. Make sure that the power switch is turned OFF and that the product is disconnected from the main power source. Refer such maintenance to qualified service personnel.

Electrical Safety

• To reduce the risk of electrical shock, this product uses a three-wire electrical cord and plug to connect to earth-ground. Make sure that the matching wall outlet receptacle is properly wired and earth-grounded.

• Never remove or install any circuit board, connect or disconnect any plug or cable, while the power is ON.

• Do not place containers holding liquid on top of this product. If a spill occurs, liquid may damage electrical or mechanical components.

Safety Against Risk of Fire

Fuses protect certain electrical circuits within this product against overcurrent conditions. For continued protection against the risk of fire, replace only with the same type and rating specified.

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Safety Notice

A011460L.EPS

System Hazards

Before operating and/or maintaining the UniCel DxC 600i System, all hazards (i.e., warning and caution statements) associated with the system should be reviewed and understood. The following list summarizes some primary hazards. System hazards are also identified.

Performing Service Procedures

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

Use of Three-Pronged Power Cord

The three-pronged power cord must only be connected to a matching three-wire grounded outlet. DO NOT use an adapter to connect the power plug to a two-pronged outlet.

Biohazardous Materials

Observe all laboratory policies which pertain to handling of infectious or biohazardous materials.

Electrical Ground

DO NOT UNDER ANY CIRCUMSTANCES OPERATE THE SYSTEM UNTIL AN ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY CONNECTED TO THE GROUND.

Electric Shock

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

Flammable Materials

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

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Moving Parts

456161-B

TO REDUCE RISK OF PERSONAL INJURY,

OPERATE ONLY WITH ALL COVERS IN PLACE.

CAUTION

A011459L.EPS

Do not place hands near any moving part while the system is operating. Lower and/or close protective guards and covers during operation. Failure to properly seat covers could lead to erroneous results.

Exposed Working Surfaces

Use caution when performing maintenance, service, or troubleshooting on the system around the CTA and UniCel DxC 600i load area.

Safety Notice

System Hazards

When exiting the CTA alignment screen, the CTA canopy is not locked during the homing procedure.

Handling Closed Tube Sampling (CTS) Auto-Gloss

The DxC analyzer and the CTA unit use an Auto-Gloss solution to lubricate CTS components. Be careful when handling the CTS Auto-Gloss bottle. Use care to prevent spills. This lubricant is extremely slippery and difficult to clean from the floor.

Sodium Azide Preservative

Reagents, calibrators, and controls used on the UniCel DxC 600 analyzer may contain small quantities (<0.1%) of sodium azide preservative. Refer to the Material Safety Data Sheets (MSDS) CD for additional information.

ISE Module Pinching Hazard

To avoid personal injury, make sure to keep your fingers clear when the ISE module is lowered at the UniCel DxC 600 analyzer.

Bar Code Labels

The use of bar code labels is a highly accurate and efficient method to identify and process laboratory samples. In order to maintain this type of accuracy, the system must be able to identify and read every bar code label to process each sample correctly. Therefore, bar code labels must be of high quality. Each label must be free from smudges, spots, or other imperfections. Follow the bar code label specifications, and bar code symbology and configuration recommendations to keep the rate of misread labels to a minimum.

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Safety Notice

CAUTION

CLASS 2 LASER LIGHT WHEN OPEN

DO NOT STARE INTO BEAM

B08479-AA

System Hazards

Laser Bar Code Caution

A label reading, "CAUTION CLASS 2 LASER LIGHT WHEN OPEN. DO NOT STARE INTO BEAM" is placed near any opening through which a bar code reading beam emits. Do not stare into beam.

Recycling Label

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

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

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

state of the European Union.

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.

Motion Error

If the same motion error occurs repeatedly, refer to the troubleshooting instructions for the specific system component. If the motion error continues, contact your Beckman Coulter representative.

System Motors

To prevent possible injury, press the STOP button on the UniCel DxC 600i System to disable the motors before attempting to clear any jams.

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Restriction of Hazardous Substances (RoHS) Labels

These labels and materials declaration table (the Table of Hazardous Substance's Name and Concentration) are to meet People's Republic of China Electronic Industry Standard SJ/T11364-2006 "Marking for Control of Pollution Caused by Electronic Information Products" requirements.

RoHS Caution Label

This logo indicates that this electronic information product contains certain toxic or hazardous elements, and can be used safely during its environmental protection use period. The number in the middle of the logo indicates the environmental protection use period for the product. The outer circle indicates that the product can be recycled. The logo also signifies that the product should be recycled immediately after its environmental protection use period has expired. The date on the label indicates the date of manufacture.

Safety Notice

System Hazards

RoHS Environmental Label

This logo indicates that the product does not contain any toxic or hazardous substances or elements. The "e" stands for electrical, electronic and environmental electronic information products. This logo indicates that this electronic information product does not contain any toxic or hazardous substances or elements, and is green and is environmental. The outer circle indicates that the product can be recycled. The logo also signifies that the product can be recycled after being discarded, and should not be casually discarded.

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Safety Notice

Alerts for Warning, Caution, Important, and Note

WARNING

WARNING indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products).

CAUTION

CAUTION indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. May be used to indicate the possibility of erroneous data that could result in an incorrect diagnosis (does not apply to all products).

IMPORTANT

Following the advice in the IMPORTANT notice adds benefit to the performance of a piece of equipment or to a process.

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

NOTE NOTE is used to call attention to notable information that should be followed during installation, use,

or servicing of this equipment.

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Revision History, iii

Safety Notice, v

Introduction, xv

CHAPTER 1: System Description, 1-1

System Description, 1-1

Introduction, 1-1 Shipping Damage, 1-2 Specifications, 1-2 Instrument and System Supplemental Specifications, 1-7

Version Information, 1-8

System Components, 1-9

DxC Analyzer, 1-9 Access Analyzer, 1-9 Closed Tube Aliquotter (CTA) Unit, 1-9

Theory of Operation, 1-11

Access Functional Differences, 1-13

Operator Control Devices, 1-13

Access Online Help Feature, 1-17

DxC 600i Main Menu Features, 1-18

Host Communication Status Bar, 1-18 Access Event Log Symbol, 1-18

Main Operating Screens, 1-18

System Monitoring, 1-20

System Operating Conditions, 1-20 Sample Status, 1-20 Test Result Errors, 1-21 CTA Event Codes, 1-21 Access Codes Converted to DxC Codes for DxC 600i Reporting, 1-22 Test Reports, 1-23 Recalling Test Results, 1-23

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Contents

CHAPTER 2: Pre-Test Activities, 2-1

Introduction, 2-1

Prepare Test Samples, 2-1

Check and Load Supplies at DxC Analyzer, 2-3

Load or Unload MC Reagents, 2-4 Refill the No Foam Container, 2-7

Load/Unload CC Cartridges at DxC Analyzer, 2-9

Check and Load Supplies at CTA Unit, 2-12

Change AV Waste Container at CTA Unit, 2-14

Change the Wash Buffer at CTA Unit, 2-16

Change the Auto-Gloss Solution at CTA Unit, 2-18

Check and Load Access Supplies and Reagents, 2-20

Load the Reaction Vessel (RV) Cartridges onto Access Analyzer, 2-22

Change the RV Waste Bag at Access Analyzer, 2-24

Change the Wash Buffer Bottle at Access Analyzer, 2-25

Change the Liquid Waste Bottle at Access Analyzer

(Optional Waste Collection Feature), 2-27

Change the Substrate Bottle at Access Analyzer, 2-29

Load a Reagent Pack onto Access Analyzer, 2-31

CHAPTER 3: System Calibration, 3-1

System Calibration, 3-1

Introduction, 3-1 Calibrate DxC Chemistries With Bar Code Labels, 3-2 Calibrate DxC Chemistries Using Assigned Calibrator Racks, 3-4 Calibrate Access Chemistries (Assays), 3-5 Calibration Override Function, 3-7 Override a Calibration for DxC, 3-7 Remove Cal Overridden Status at DxC, 3-7 Override a Calibration or Supply for Access, 3-8 Remove Cal Overridden Status at Access, 3-8 Run QC Samples, 3-9 Run Control Samples With Bar Code Labels and Auto Generation of

Control Enabled, 3-9

Run Manually Programmed Control Samples, 3-10

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CHAPTER 4: Sample Programming and Processing, 4-1

Sample Programming and Processing, 4-1

Introduction, 4-1 DxC 600i Setup Options, 4-2 Chemistry Configuration, 4-3

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Units/Precision, 4-5 Default Sample Type, 4-7 DxC 600i Reflex Testing, 4-8 Access Priority Option, 4-10 Obstruction Detection and Correction (ODC), 4-11 Special Calculations, 4-14 Sample Programming With Bar Codes, 4-16 Sample Programming Without Bar Codes (Manual

Programming), 4-18 Sample Processing, 4-19 Sample Reruns, 4-22 Independent Operating Modes, 4-23 Access: Small Sample Volume Assays, 4-23

CHAPTER 5: Post-Test Activities, 5-1

Introduction, 5-1

System Power Down Procedures, 5-1

Contents

Power Down the DxC Analyzer, 5-2

Introduction, 5-2 Shutdown, 5-2

Power Down the CTA, 5-5

Power Down the Access Analyzer, 5-6

Restart the DxC 600i System, 5-7

Restart the Access Analyzer, 5-8

Reboot the DxC 600i System, 5-9

Reboot the CTA Unit, 5-10

Reboot the Access Analyzer, 5-11

Place the CTA Unit Offline, 5-13

Home the DxC Analyzer and CTA Unit, 5-15

Prime the DxC 600i System, 5-16

Event Log Screens, 5-18

Home (Initialize) the Access Analyzer, 5-20

CHAPTER 6: Maintenance Procedures, 6-1

Introduction, 6-1

Electronic Maintenance Log, 6-1

Feature Summary, 6-1 Accessing the Scheduled Log Feature, 6-2 Screen Description, 6-3 Help, 6-3 Procedure, 6-3 Electronic Maintenance Tabs and Tasks, 6-5

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Contents

Maintenance Instructions, 6-6

CTA Maintenance (Twice-Monthly), 6-7

CTA Maintenance, 6-7 Clean the CTA Aliquot Probe, CTA Piercing Probe, CTA Probe Wash

Station, and Auto-Gloss Dispense Station, 6-8

CTA Maintenance (Yearly), 6-9

Replace the CTA Piercing Probe, 6-9 Replace the CTA Aliquot Probe, 6-10 CTA Aliquot Probe Vertical Alignment, 6-13 Replace CTA Syringes, 6-16 Replace the Peristaltic Drain Pump Tube (Hoses at Top of

Pump), 6-20

Replace the Peristaltic Drain Pump Tube (Hoses at Bottom of

Pump), 6-23

CTA Maintenance (As-Needed), 6-28

Flush the CTA Aliquot Probe, 6-28 Replace the CTA Pick and Place Head, 6-31 CTA Alignment: Pick and Place Crane (Horizontal), 6-34 CTA Alignment: Pick and Place Head (Vertical), 6-39 CTA Alignment: Pick and Place Head to AV Shuttle Automatic Fine

Alignment, 6-43

CTA Accuracy PVT Procedure, 6-45

CTA Carryover PVT Procedure, 6-47

APPENDIX A: Supplementary DxC 600i Information, A-1

Supplementary Information, A-1

Introduction, A-1 Program Structure, A-2 System Operating Conditions, A-10 Independent Operating Modes, A-11

APPENDIX B: Common Event Codes, B-1

Common Event Codes, B-1

Introduction, B-1 CTA Event Codes, B-2

Index

Introduction

The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, cerebrospinal fluid, whole blood, amniotic fluid and others (sample type is chemistry dependent).

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Introduction

A016702P.EPS

A2 CTA DxC

Intended Use

Figure 1 UniCel DxC 600i System

1. UniCel DxC 600 Analyzer

2. Closed Tube Aliquotter (CTA) unit

3. Access 2 Analyzer

Scope of Manual

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

Operator Indicator Box

An operator indicator box is located throughout this manual before a procedure. The operator indicator box (shown below) identifies where to start the procedure. In the example below, an "X" is located within the DxC box, which indicates that the operator needs to go to the UniCel DxC 600 analyzer to start the procedure. DxC = UniCel DxC 600 analyzer, CTA = Closed Tube Aliquotter unit, A2 = Access 2 analyzer

Example:

xvi

IMPORTANT

From this point forward, the UniCel DxC 600i System will be described in abbreviated or general terms. The UniCel DxC 600 analyzer will be referred to as the "DxC analyzer", the Closed Tube Aliquotter unit will be referred to as the "CTA unit", and the Access 2 analyzer will be referred to as the "Access analyzer".

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System Description

DxC Load Area

DxC 600i Load Area

Off-load Area

DxC AnalyzerAccess Analyzer CTA Unit

DxC

Monitor

Access

Monitor

A007128P.EPSE016701L.EPS

Introduction

As shown in Figure 1.1, the DxC 600i System consists of a DxC analyzer, an Access analyzer, and a CTA unit. The following paragraphs give a brief description of the system and how it functions. In addition, this chapter identifies some important hazards inherent to the system in a laboratory environment.

CHAPTER 1

System Description

Figure 1.1 DxC 600i System Description

1. Primary Sample Rack

2. CTA Bar Code Reader

3. CTA Tube Clamp

4. CTA Sample Wheel

5. Aliquot Vessels (AVs)

7. Access Sample Carousel with AVs

8. Access Bar Code Reader

6. DxC Bar Code Reader

9. AV Waste Container (behind CTA door)

10. Reaction Vessel (RV) Waste Bag

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System Description

Shipping Damage

Each DxC 600i System is carefully examined and checked by Beckman Coulter, Inc. before it is shipped. When you receive your new DxC 600i 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.

If there is no damage to the shipping container, the Beckman Coulter Service Representative will supervise the unpacking of your system. If it is damaged in any way, file a complaint with the carrier. If there is no damage, a visual and operational check of your system will be performed.

Specifications

System Clearance

Table 1.1 System Clearance

Area Affected Clearance Needed

Sides Minimum of 18 inches (45.8 cm) clearance, both sides.

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

at the back.

Top Minimum of 22 inches (55.9 cm)

Front Minimum of 25 inches (63.5 cm)

Sunlight and Drafts

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

Drain

Liquid waste exits the DxC 600i System by 3 separate effluent streams:

Table 1.2 System Waste Disposal

Item Description

DxC Waste drain 16 L/hour

Maximum drain height of 36 inches (91.4 cm)

CTA May be plumbed into existing DxC effluent stream

Access Plumbed to Access Waste Container

May be plumbed into existing DxC effluent stream

1-2

The DxC System should be located near a sink or floor drain to accommodate the waste effluent at a minimum rate of 16 liters/hour.

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

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System Description

Power Requirements

Table 1.3 Power Requirements – DxC 600 Analytic Unit

Item Requirement

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

14 A at low line, exclusive of power on surge

Frequency 50/60 Hz

BTU generated 10,500 BTU/hour

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

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

Item Requirement

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

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

Frequency 50/60 Hz

BTU generated 1500 BTU/hour

Power connector 15A current rating, IEC 320 standard connector

Table 1.5 Power Requirements – CTA Component

Item Requirement

Operating range 100-120 VAC ± 10% (90-132 VAC); 6A (nominal)

OR 200-240 VAC ± 10% (180-264 VAC); 3A (nominal)

Frequency 50/60 Hz

BTU generated 2900 BTU/hour

Power connector 15A current rating, IEC 320 standard connector

Table 1.6 Power Requirements – Okidata B4350 LED Printer

Item Requirement

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

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

Frequency 50/60 Hz

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

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Power connector 15A current rating, IEC 320 standard connector

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System Description

Table 1.7 Power Requirements – Access 2 Analytic Unit

Operating range 100-120 VAC ± 10% (90-132 VAC); 7A (nominal)

Frequency 50/60 Hz

BTU generated 2730 BTU/hour

Power connector 15A current rating, IEC 320 standard connector

Table 1.8 Power Requirements – Access 2 Console (PC System and Monitor)

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

Frequency 50/60 Hz

Item Requirement

OR 200-240 VAC ± 10% (180-264 VAC); 3.5A (nominal)

Item Requirement

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

BTU generated 1500 BTU/hour

Power connector 15A current rating, IEC 320 standard connector

Notes on the System Power

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

IMPORTANT

protection of the electronic circuitry.

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

CAUTION

Only operate the system from a 3-wire power source. DO NOT use a 2-prong adapter or a 2-wire AC power source.

1-4

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System Description

Environmental Conditions

Table 1.9 Working Environment, Temperature, Warm-up Time, Humidity and Elevation – DxC 600i System

Item Specification

Working environment Indoor use only

Ambient temperature +18°C to +32°C, ≤ 2°C change in 1/2 an hour

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

Relative humidity 20-85% relative, non-condensing

Elevation ≤ 4200 ft (1280 m)

> 4200 ft (1280 m) altitude modification required

NOTE These specifications apply to the DxC analyzer only. For specifications for the Access 2 analyzer, refer

to the Access 2 Instructions for Use.

Water Requirements

Table 1.10 Water Requirements – DxC Side

Item Specifications

Flow Rate 0.6 L/min peak flow rate

16 L/hr, minimum continuous flow rate

Temperature +15°C to +25°C

Water pressure 30-90 psi

Table 1.11 Water Quality Requirements

CLSI (CLRW) 4TH Ed. C03 --A4 Formerly NCCLS (Type I & II)

Notes Replaces Type I & II.

CLSI

CLRW

Organic Impurities

Total Organic Carbon (TOC)

Microbiological Impurities

Maximum microbial content colony forming unit (CFU/mL)

Ionic Impurities

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

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

10 CFU/mL 10 CFU/mL

10 MW.Cm 1.0 MW.Cm

4th Ed. C03 --A4

Beckman Coulter Requirements

Not Applicable

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System Description

Table 1.11 Water Quality Requirements (Continued)

CLSI (CLRW) 4TH Ed. C03 --A4 Formerly NCCLS (Type I & II)

Notes Replaces Type I & II.

4th Ed. C03 --A4

Particulate & Colloid Content Purification process

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

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

pH Not Applicable Not Appiicable

Maximum silicate (mg/mL) SiO

Not Applicable Not Applicable

CTA and Access - None required.

1-6

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Instrument and System Supplemental Specifications

Table 1.12 Instrument and Supplemental Specifications

Item Description

Installation Category II

Pollution Degree 2

EN55011 Meets Class A

Sound Pressure Level ≤ 65 dBA with covers down

Maximum Leakage Current 240 V, 50 Hz: 330 µA

System Description

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System Description

E011858S.EPS

Version Information

A2 CTA DxC

Version Information

The Version Information screen provides a condensed reference to the software version number and the chemistry database number.

View the Version Information Screen

Select Setup from the menu bar.

Select 13 Version Information.

OR Type

13 in the Option Number field.

View the Version Information screen.

Figure 1.2 Version Information Screen

1-8

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System Components

The DxC 600i System consists of three major components: a DxC analyzer, an Access analyzer, and a CTA unit. The following paragraphs briefly describe these components.

DxC Analyzer

The DxC analyzer is designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, proteins, and other chemistries. The DxC analyzer has many components. Refer to the UniCel DxC Synchron Clinical Systems Reference Manual for a detailed description.

WARNING

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

System Description

System Components

Access Analyzer

The Access analyzer is an automated system that performs a wide variety of immunoassays on body fluid samples. Refer to the Access 2 Immunoassay System Reference Manual for a detailed description on Access components.

Closed Tube Aliquotter (CTA) Unit

As shown in Figure 1.3, sample racks are loaded onto the DxC 600i load area after programming functions are completed. The operator presses the RUN button (1) to begin the test process. When the RUN button is pressed, the CTA load pusher feeds the sample racks towards the CTA shuttle. The shuttle sends each sample rack past the CTA bar code reader and into the CTA sample wheel.

If the sample needs to be tested at the DxC analyzer, the sample rack enters the DxC load area. The DxC load pusher feeds the sample racks toward the DxC shuttle. Finally, the shuttle sends each sample rack past the DxC bar code reader and into the DxC sample wheel.

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System Description

A011868P.EPS

System Components

Figure 1.3 DxC 600i Load Area

1. RUN Button

2. Load Gate

3. Sample Rack

If the sample needs to be tested at the Access analyzer, the piercing probe (1) in Figure 1.4 is lubricated with an Auto-Gloss solution and a hole is pierced into the sample tube cap. (Note: The CTA goes through the cap piercing sequence on all tubes.) The aliquot probe (2) then moves into position, aspirates the sample, and places it into an aliquot vessel (AV) (3) at the AV queue area (4). The cap piercer probe and aliquotter probe are cleaned with a wash buffer and the process is repeated.

A pick-and-place head (5) picks up each AV from the AV queue tray and places it on the automation rack (6) at the Access sample carousel (7). Finally, the Access analyzer transfers the AV material into reaction vessels (RVs) for processing.

1-10

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Figure 1.4 Sample Aliquotting Area

A007256P.EPS

System Description

Theory of Operation

1. CTA Piercing Probe

2. CTA Aliquot Probe

3. CTA Aliquot Vessel (AV)

4. CTA AV Queue Tray

Theory of Operation

The entire operating process is described in the following flow chart (Figure 1.5). When sample preparation and calibration activities are completed, programmed samples are loaded onto the DxC 600i load area. Press the

If an immunoassay sample needs to be tested, the CTA pierces the cap on the sample tube, aliquots the sample into an AV, and sends it to the Access analyzer. If a general chemistry sample needs to be tested, the CTA sends the sample to the DxC analyzer.

An AV holds a maximum of 450 µL. Rarely, the volume needed to complete Access testing for a sample will exceed this maximum. In this event, the sample will be marked as incomplete. To complete the testing, run the sample again.

The test status is viewed from the DxC 600i monitor while the system is operating. A test report may be generated for both analyzers after testing has been completed. If a rerun is required, the operator places the sample rack back onto the DxC 600i load area to rerun the test.

5. CTA Pick and Place Head

6. Access Automation Rack

7. Access Sample Carousel

RUN button on the CTA to start the testing process.

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System Description

START

E016700L.EPS

Prepare

samples and

check system

supplies

Calibrate

DxC and

Access

analyzers

Enter sample

programming

data

Put sample

racks onto

DxC 600i

load area

CTA barcode reader scans

sample IDs

NOTE:

IA = Immunoassay

GC = General Chemistry

CTA pierces tube

caps and aliquots

sample material

into AV for

IA testing

CTA moves AV

containers to

Access

Access processes

IA samples

CTA moves AVs to

waste bag when

completed

DxC and

Access tests

are monitored

CTA moves

sample racks onto

DxC load area

DxC receives GC

samples

DxC processes

GC samples

Sample racks

move to DxC

oﬄoad area when

completed

Sample report

generated for

DxC and Access

Rerun, or

remove sample

from system

End

Rerun

Theory of Operation

Figure 1.5 DxC 600i System Operating Process

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Access Functional Differences

When the Access analyzer is operating as part of the DxC 600i System, certain operating functions are not available (grayed out) at the Access analyzer. Those functions are listed in Table 1.13.

Table 1.13 Access Functional Differences

From Access Main Menu Not Available When CTA is Online

System Description

Access Functional Differences

Diagnostics

From Access Main Menu Not Available With DxC 600i

Configuration • Derived Results

Sample Manager (Test Request) • Dilution Factor

a. Function available when Access is in Not Ready state.

Operator Control Devices

During normal operation, the operator uses various control devices such as the keyboard, a touchscreen monitor, and mouse. Basic operating functions for both analyzers are controlled and reviewed from the DxC 600i monitor and keyboard. Calibration and maintenance functions are controlled from DxC 600i and Access monitors and keyboards. Information is selected and entered into the system through touch screen monitors, with a mouse, or at a keyboard. Refer to Figure 1.6 and Figure 1.7.

• Initialize System

• Volume Check

• Device Diagnostics

• Reference Ranges (Gray Zone)

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System Description

A016704P.EPS

A016716P.EPS

Operator Control Devices

Figure 1.6 DxC 600i Keyboard and Monitor

1. DxC 600i Monitor and Keyboard

2. DxC Analyzer

Figure 1.7 Access Keyboard and Monitor

1. Access Monitor and Keyboard

2. Access Analyzer

Control buttons are used to start the test process, to prioritize a sample run, or to stop the process under certain conditions as described in Table 1.14 through Table 1.16. Control buttons are shown in Chapters 4 and 5.

1-14

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Table 1.14 DxC Control Buttons

Control Type Location, Function, and Usage

System Description

Operator Control Devices

Run (hard wired button)

Priority (hard wired button)

Stop (hard wired button)

Pause (software button)

Table 1.15 CTA Control Buttons

Control Type Location, Function, and Usage

Run (hard wired button)

Priority (hard wired button)

Stop (hard wired button)

Pause (software button)

• Located in front of DxC System, but covered during routine operation.

• Starts test process at DxC analyzer for independent operating mode.

• Located in front of DxC System, but covered during routine operation.

• Starts priority (STAT) test at DxC analyzer for one or more samples for

independent operating mode.

• Located in front of DxC System.

• Stops the test process at DxC analyzer.

• Used in maintenance/repair procedures at DxC.

• Located under the Instrument Commands icon.

• Prevents new or additional tests from starting at DxC System or CTA

unit without wasting sample or reagent. Any tests with reagent already added are completed.

• Used to interrupt the DxC System when a rack needs to be removed from sample carousel, or to avoid wasting reagent.

• Located in front of CTA unit.

• Starts the test process at DxC 600i System.

• Located in front of CTA unit.

• Starts a priority (STAT) test at DxC 600i System for one or more

samples.

• Located in front of CTA unit.

• Stops the CTA from routing and/or aliquotting samples.

• Used in maintenance/repair procedures at CTA.

• Located under the Instrument Commands icon.

• Prevents new or additional tests from starting at CTA without wasting

sample or reagent. Any tests with reagent already added are completed.

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System Description

Operator Control Devices

Table 1.16 Access Control Buttons

Control Type Location, Function, and Usage

Stop (hard wired button)

Stop (software button)

Pause (software button)

Run (software button)

CTA (software button)

• Located between Access and CTA unit.

• Stops the test process at Access analyzer.

• Use during an emergency situation. If the STOP button is pressed,

sample processing may not stop immediately because another process is in control of the system. If this is the case, a message appears on the Access monitor to notify the operator. If required, press the STOP button again to stop sample processing.

• Located on every Access screen.

• Stops the test process at Access analyzer. If the STOP button is

pressed, sample processing may not stop immediately because another process is in control of the system. If this is the case, a message appears on the Access monitor to notify the operator. If required, press the STOP button again to stop sample processing.

• Located on every Access screen.

• Interrupts the Access analyzer at the next opportunity. In-process

tests are completed.

• Use to add or delete test requests without initializing the system.

• Located on every Access screen.

• Starts the test process at Access analyzer.

• Located on Main menu.

• Stops sample processing at CTA unit.

• CTA must be placed offline to conduct diagnostic activities at Access

analyzer. Refer to CHAPTER 5, Post-Test Activities for instructions.

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A2 CTA DxC

Access Online Help Feature

Operating, maintenance, troubleshooting, and diagnostics information for the Access analyzer can be obtained through the Access Online Help feature. Not all Access online help features are applicable to the DxC 600i System.

System Description

Access Online Help Feature

NOTE

The Help icon on the DxC 600i menu bar provides information from the DxC 600i and DxC Instructions For Use manuals. Similarly, the Access Online Help feature does not provide information for the DxC analyzer or CTA unit.

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System Description

DxC 600i Main Menu Features

A2 CTA DxC

DxC 600i Main Menu Features

Host Communication Status Bar

At the top, right hand corner of the Main menu is a Host Communication Status Bar (1). Refer to

Figure 1.8. The blue bar indicates that the host is sending information. The green bar indicates that

the host is receiving information. A red circle with a slash through it indicates that the host is not communicating.

Access Event Log Symbol

Next to the Host Communication bar is an Access Event Log symbol (2) that looks like an exclamation mark. Refer to Figure 1.8. If the background behind the symbol is clear, the Access is operating normally. If the background behind the symbol turns yellow, a caution condition has occurred at the Access analyzer. If the background turns red, a warning condition has occurred at the Access analyzer that demands immediate attention.

Main Operating Screens

DxC 600i System operating functions and programming functions are initiated from the Main menu screen at the DxC 600i monitor. Refer to Figure 1.10.

1-18

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Figure 1.8 DxC 600i Main Menu Screen

E016706S.EPS

System Description

Main Operating Screens

E016705S.EPS

1. Host Communication Status Bar

2. Access Event Log

The Access analyzer Main menu screen is used during Access calibration, maintenance, reagent load/supply, and diagnostics activities, or when the CTA unit is not functional. Refer to Figure 1.9.

Figure 1.9 Access Main Menu Screen

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System Description

E016707S.EPS

321 4

System Monitoring

The system can be monitored to check system operating conditions, sample test status, test errors, and assay flags. A printed test report is automatically generated after testing.

System Operating Conditions

During normal operation, the operating condition of the entire DxC 600i System is identified at the top, left corner of any screen at the DxC 600i monitor. The operating condition is arranged in the following order:

Access ¦ CTA ¦ DxC / (MC/CC)

Refer to APPENDIX A, Supplementary DxC 600i Information for further details.

Sample Status

The sample status for each sample can be monitored from the DxC 600i monitor at the Main screen.

The sample status for each sample can be viewed for the Access analyzer, AV area, CTA unit, or DxC analyzer. To view a sample status, select the Access (1), AV (2), CTA (3), or DxC (4) tab on the screen. Refer to Figure 1.10.

Figure 1.10 DxC 600i Main Menu Screen Displaying Access Sample Status

1. Access Tab

2. AV Tab

3. CTA Tab

1-20

4. DxC Tab

5. Sample Status Icon

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System Description

System Monitoring

NOTE Any sample programmed as a STAT is highlighted in a yellow rack status box. Other functional keys

(tab dependant) include:

• Results F1 - Retrieves results for samples that are in-progress on the system.

• Unload F2 - Requests particular racks to be unloaded at next possible opportunity.

• Pre Run Summary F9 - Lists a variety of information on reagent and calibration status, as well as

• Post Run Summary F10 - Lists error conditions that occurred on the system, including suppressed

results and no sample detected.

• Log F8 - Lists errors detected on samples, for example, incomplete tests, host query timeout,

dulplicate sample ID, programming conflict. If the error is logged, the Log F8 key is highlighted in yellow. The yellow highlight disappears when the key is selected. The error will stay in the Sample Log screen for 12 hours.

A sample status icon (5) Figure 1.10, appears in front of the listed sample. Samples are listed in a rack status box directly below the sample status icon legend. Table 1.17 lists the function of each sample status icon.

Table 1.17 Sample Status Icons

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

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

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

Incomplete Sample has some tests that are still pending.

Complete All tests have been completed.

Aliquotted Identifies samples aliquotted at the CTA unit.

Aspirated Indicates initial aspiration of the sample was completed.

Test Result Errors

Test results are checked against chemistry reaction flag limits to qualify the reagent, calibration, or sample. Checks are performed against the final results and on interim reaction data for all samples, including calibrators. Any calibrator, sample result, or reaction step outside of these limits is flagged. Test result errors and codes that affect the chemistry results are described in the UniCel DxC Synchron Clinical Systems Reference Manual and the Access 2 Immunoassay System Reference Manual.

Icon Function

with that Sample ID.

the host.

CTA Event Codes

CTA error codes that an operator may see during normal operation are located in Appendix B of this manual. A complete list of CTA error codes is located in APPENDIX B, Common Event Codes of this manual.

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System Description

System Monitoring

Access Codes Converted to DxC Codes for DxC 600i Reporting

Certain Access codes (flags) are converted to DxC codes. This information is noted on the DxC 600i report. Refer to Table 1.18 for details.

Table 1.18 Access Codes Converted to DxC Codes

Access DxC

Description Value Flag Remarks Inst

Code

Normal result result none none none print result none

Indeterminate "No value" IND INDETERMINATE none suppress RE

Out of range high >highest OVR none none print: >X GT

Curve expired result CEX none E print result none

Substrate expired result EXS none S print result none

Lot expired result LEX none R print result none

Lower than reportable result result LOW OIR LO none print result LO

< lowest none none none print: < X LT

No curve – cal required "No value" NCR CHEM NEEDS CAL

Pack expired result PEX none D print result none

Control outside QC limits NA QCF NA NA NA NA

Control lot expired NA QEX NA NA NA NA

Quantity not sufficient "No value" QNS NO SAMP DETECT NA incomplete NA

Insufficient reagent dispensed "No value" QSD INSUF FLUID DISP NA incomplete NA

Reflex test NA RFX NA NA NA NA

Obstruction detected in the primary probe

RLU is out of measuring range "Cancelled" RLU RLU RANGE none suppress OR

Instrument error NA SYS DEVICE ERROR NA incomplete NA

"No value" CLT none none Probe Obstruct none

Result Host

Code

incomplete NA

Incubator temperature error "No value" TRI INCUBATOR TEMP none suppress TM

Substrate temperature error "No value" TRS SUBSTRATE TEMP none suppress TM

Carousel temperature error "No value" TRW CAROUSEL TEMP none suppress TM

Gray zone NA GRY NA NA NA NA

AV Expired - loaded > 3 hours NA AVX AV EXPIRED NA incomplete NA

Sample carousel cover opened NA AVC A2 DOOR OPEN NA incomplete NA

User unload automation sample NA AVU SAMP REMOVED NA incomplete NA

Sample ID conflict with DxC 600i console

1-22

NA AVS A2 ID CONFLICT NA incomplete NA

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Table 1.18 Access Codes Converted to DxC Codes (Continued)

Access DxC

System Description

System Monitoring

Description Value Flag Remarks Inst

Code

Can’t run test (Undetected by CTA)

Cannot Calculate Result "No value" CCR none none RESULT ERR none

a. NA = Not applicable.

"Cancelled" other CHEM NOT RUN NA incomplete NA

Result Host

Code

Test Reports

When testing is completed, a test report is generated and printed automatically. Test results are compared against customer defined reference ranges. Various test reports are shown in the UniCel DxC Synchron Clinical Systems Reference Manual and the Access 2 Immunoassay System Reference Manual.

Relative Light Units (RLUs) are not printed on DxC reports. RLUs are only printed on Access reports.

NOTE

Printed test reports may display “#” or “@” in place of numbers or text if the information to be displayed exceeds the maximum allowable display area on the printout. To see the correct information, view the test report from the console.

Recalling Test Results

Test results can be recalled from the Recall Results screen by various methods as shown in

Figure 1.11.

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System Description

System Monitoring

Figure 1.11 Recall Results Screen

1-24

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Introduction

The following pre-test activities should be completed before testing the samples on your DxC 600i System:

• Prepare test samples.

• Check and load system supplies at DxC analyzer, CTA unit, and Access analyzer.

CHAPTER 2 Pre-Test Activities

Prepare Test Samples

Select Sample Containers

Prepare samples according to the type of container to be used. The following information describes sample containers used on the DxC 600i System.

IMPORTANT

Table 2.1 DxC 600i Sample Containers

Used in non-reserved racks • 13 x 75 mm and 13 x 100 mm open and capped

Used in reserved racks • 2.0 mL cup (PN 81902 or PN 652730) in 5 mL transfer tubes

DO NOT put 13 x 75 mm or 16 x 75 mm tubes in 13 x 100 or 16 x 100 racks.

Use Description

(B-D Hemogard

• 16 x 100 mm open and capped (B-D Hemogard only) samples tubes

• 15 x 92 mm and 15 x 75 mm open and capped Sarstedt S-Monovette

• 0.5 mL cups (PN 651412)

• 2.0 mL cups (PN 81902 or PN 652730)

(PN 979272)

• 1.0 mL pediatric insert cup (PN 81916) in a 12 or 13 x 75 mm tube

• 2.0 mL insert cup (PN 81917) in a 16 x 75 mm tube

and Greiner Vacuetteb) sample tubes

sample tubes

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Pre-Test Activities

Prepare Test Samples

Table 2.1 DxC 600i Sample Containers (Continued)

Use Description

If running Pediatric samples for DxC only chemistries, use

• 0.5 mL cups (PN 651412) in metal cup inserts (PN 476406)

• Microtainer (baby bullets) in pediatric tube adapter (PN 472987).

Load onto CTA for processing.

If running Pediatric samples requiring both DxC and Access chemistries, use

• 1.0 mL pediatric insert cup (PN 81916) in pediatric tube adapter (PN 472987). First load directly onto Access using racks 1800-

1899. When finished processing on Access, transfer sample to CTA for DxC processing.

• For Access 2 Total bhCG, diluted bhCG and all Access 2 tests that use sample volumes of less than 20 µL per test, you must use Aliquot Vessel (AV) containers manually loaded in automation racks (1900 -1999).

a. Registered trademark of the Becton Dickinson Corporation.

b. Registered trademark of the Greiner Corporation.

c. Registered trademark of the Sarstedt Corporation.

d. Requires Sarstedt S- Monovette Type CTS and CTA hardware. The 15 x 75 mm tubes must be installed into a special, non-

reserved, multi-colored rack (PN A18642, package of 10, amber/purple). Rack IDs for Non-Reserved Racks using 15 x 75 mm tubes, must be defined using the 75 mm Racks field on the "Reserved Racks/Obstruction Detection Setup" screen.

CAUTION

Visible blood MUST be removed from the top of capped tubes using a cottontipped applicator moistened with DI water.

2-2

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Check and Load Supplies at DxC Analyzer

A2 CTA DxC

Select Rgts/Cal from the menu bar.

Select the DxC tab on the screen. Reagents highlighted in yellow indicates that the reagent supply is getting low. Reagents highlighted in red indicates that the particular reagent supply

is empty or requires calibration or has exceeded the on-board stability and requires immediate attention.

Pre-Test Activities

Check and Load Supplies at DxC Analyzer

Load/Unload MC Reagents onto DxC Analyzer

The DxC analyzer loads and unloads MC bulk reagents using the bar code system. The reagent bar code information includes:

• Test or Reagent Name (1)

• Lot Number (2)

• Expiration Date (3)

• Serial Number (4)

Refer to Figure 2.1. Reagent information is encoded on the label and read by the bar code reader when the reagent is loaded or unloaded from the system. This information makes each container unique.

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Pre-Test Activities

A015919P.EPS

Check and Load Supplies at DxC Analyzer

Figure 2.1 MC Reagent Information

1. Test or Reagent Name

2. Lot Number

IMPORTANT Reagent preparation may be necessary prior to loading certain MC reagents onto the DxC

analyzer. For further details, refer to Table 2.2 and the corresponding chemistry information sheet in the Synchron Clinical Systems Chemistry Information Sheets.

Table 2.2 MC Reagent Preparation

Modular Chemistries (MC) Preparation Required

GLUCm Allow reagent to equilibrate to room temperature for at least 8

Load or Unload MC Reagents

IMPORTANT You must wear a CLEAN pair of gloves to load new reagents.

Select Rgts/Cal from the menu bar.

Select the DxC tab on the screen.

3. Expiration Date

4. Serial Number

hours.

2-4

Select the modular chemistry MC Rgts.

Select Load F1.

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A016709P.EPS

Open the door (1) of the DxC Analyzer to access MC reagents.

Pre-Test Activities

Check and Load Supplies at DxC Analyzer

NOTE

Figure 2.2 Accessing DxC MC Reagents

Wash concentrate and Auto-Gloss are located behind the DxC center door.

1. DxC Analyzer Door

Disconnect the straws from the fittings and remove the reagents from the tray. Do not scan the bar code of the reagent bottle when removing it.

CAUTION

To avoid contaminating the reagent, do not touch the draw tube in the following steps. Handle the cap/draw tube assembly by the cap only. Do not put the straw on the instrument or on the ground. Do not pool reagents.

Replace the old bottle with the new bottle. Unscrew the caps of both bottles and place the cap from the old bottle onto the new bottle.

Replace the reagents on the tray and connect the fittings to the straws.

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Pre-Test Activities

A016710P.EPS

Check and Load Supplies at DxC Analyzer

Use the hand-held bar code reader (1) shown in Figure 2.3, scan the reagent bar code on the new reagent bottle(s). The system makes a sound to indicate a successful bar code read.

Check the monitor to verify that the reagent data is displayed. When the bar code is scanned, the reagent screen updates with current reagent information. If the bar code can not be scanned, manually clear the reagent by selecting

Figure 2.1).

Clear F1, type new information (see

NOTE

Figure 2.3 Bar Code Reader and Reagent Storage Area

The Lot # field has 6 characters only. Do not enter the alpha character of the lot number.

1. Hand-held Bar Code Reader

2. Reagent Storage Area

Close the door and select Done F10. For loaded chemistries, continue to Step 11.

Calibrate reagents and run Quality Control (QC) materials before processing samples.

2-6

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Refill the No Foam Container

The No Foam Container shown in Figure 2.4 (2) is refilled by pouring a fresh bottle of No Foam solution into the empty container on the instrument.

Figure 2.4 No Foam Container (DxC 800 shown)

Pre-Test Activities

Check and Load Supplies at DxC Analyzer

1. Lid

2. No Foam Container

3. Quick Connector

4. Cap

CAUTION

Wear appropriate Personal Protective Equipment (PPE), including face and eye protection.

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

Refer to Figure 2.4 and refill the No Foam Container as follows:

Select Rgts/Cal from the menu bar.

Select the DxC tab. Select the MC Rgts button.

A93695AC

Select Load F1.

Open the center door on the DxC to access the No Foam Container.

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Pre-Test Activities

Check and Load Supplies at DxC Analyzer

Lift the lever on the hydropneumatic drawer and pull the drawer out.

NOTE

Wipe off any dust from around the top of the No Foam Container lid.

Vent the No Foam Container by disconnecting the quick connector (3) at the supply side of the container. Refer to Figure 2.4.

NOTE

Using the No Foam Container Cap Wrench, loosen the Cap (4) of the No Foam Container by turning the wrench counterclockwise.

NOTE

Unscrew the cap (4) from the top of the lid (1).

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

If you pull the drawer all the way out, it will lock. To unlock the drawer, push in the locks on each

side of the drawer and push the drawer in.

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

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

Pour the contents of the bottle into the No Foam Container (2).

Wipe off any spillage.

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

Reattach the quick connector (3).

Slide the drawer back into the instrument and close the door.

Select Done F10.

2-8

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A2 CTA DxC

Load/Unload CC Cartridges at DxC Analyzer

As shown in Figure 2.5 and Figure 2.6, the DxC analyzer also loads and unloads CC reagents using the bar code system. The reagent bar code information includes:

• Test or Reagent Name (1)

• Lot Number (2)

• Expiration Date (3)

• Serial Number (4)

Pre-Test Activities

Load/Unload CC Cartridges at DxC Analyzer

Figure 2.5 CC Reagent Cartridge

1. Test or Reagent Name

2. Lot Number

A016485P.EPS

3. Expiration Date

4. Serial Number

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Pre-Test Activities

Load/Unload CC Cartridges at DxC Analyzer

Figure 2.6 CC Reagent Information

1. Test or Reagent Name

2. Lot Number

IMPORTANT Reagent cartridge preparation may be necessary prior to loading certain CC reagents onto the

DxC analyzer. For further details, refer to the corresponding chemistry information sheet in the Synchron Clinical Systems Chemistry Information Sheets.

Load or Unload CC Reagents

Select Rgts/Cal from the menu bar.

Select all positions to be loaded or unloaded. Selected positions are highlighted. Use the up and down arrows to access screens for additional chemistries.

Select Load F1.

To unload reagent:

• When the screen prompts you to remove the cartridge (1), open the reagent carousel door. The cartridge to unload is positioned on either the upper or lower reagent carousel. A blinking bar code reader indicates which carousel position to unload from the upper and lower reagent carousels. Upper reagent carousel positions (2) are 31 to 59. Lower reagent carousel positions (3) are 1 to 30. Grasp the cartridge at top and bottom, lift up a little and pull back. Refer to Figure 2.7.

3. Expiration Date

4. Serial Number

2-10

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Pre-Test Activities

Load/Unload CC Cartridges at DxC Analyzer

• As the cartridge is moved in front of the bar code reader, a beep indicates that the bar code is read. Check the screen to verify reagent data is removed from the position selected. If the bar code does not read, manually clear the position. To manually clear, select

Figure 2.7 CC Reagents

Clear F1.

1. Reagent Cartridge

2. Upper Reagent Carousel Positions 31 to 59

3. Lower Reagent Carousel Positions 1 to 30

To load reagent:

• When the screen prompts you to load the cartridge, open the reagent carousel door. Move the cartridge in front of the bar code reader that blinks. A beep indicates that the bar code is read.

• Check the screen to verify reagent data is added to the selected position. If the bar code does not scan, manually enter the information.

NOTE

Close the reagent carousel door.

If multiple positions are selected to load or unload, repeat Step 4-6.

Before processing samples, calibrate and run QC if needed.

This field has 6 characters only. Do not enter the alpha character of the lot number.

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Pre-Test Activities

A007263L.EPS

Check and Load Supplies at CTA Unit

A2 CTA DxC

Check and Load Supplies at CTA Unit

Check the CTA Supplies

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the Reagent/Calibration screen to view the supply status. A supply highlighted in yellow indicates that the supply is getting low. A supply highlighted in red

indicates that the particular supply is too low and requires immediate attention.

Load Aliquot Vessels (AV) Cartridges onto CTA Unit

As shown in Figure 2.8, aliquot vessels are packaged in a cartridge. Each cartridge holds 98 vessels. The AV compartment holds up to 294 AVs. If the AV supply has <60 AVs, the AV Supply button turns yellow. If the AV supply has <28 AVs, the AV Supply button turns red.

Figure 2.8 Loading the AV Cartridge

2-12

1. AV Supply Door

2. AV Load Door

3. AV Cartridge

4. AV Stora ge Rack

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Load the AV Cartridge

Obtain an AV container cartridge.

Peel off the protective covering from the cartridge.

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the screen.

Select AV Supply.

Select Load F1.

Pre-Test Activities

Check and Load Supplies at CTA Unit

Open the AV supply door.

Open the AV load door and insert the AV cartridge into AV storage rack as shown in Figure 2.8.

Press down firmly on the AV load door so that the cartridge spine releases from the AVs.

Open the AV load door and remove the spine.

Close the AV load door.

Close the AV supply door.

Select Done to let the system know that the AVs are loaded.

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Pre-Test Activities

Change AV Waste Container at CTA Unit

A2 CTA DxC

Change AV Waste Container at CTA Unit

Refer to Figure 2.9. The AV Waste Container is located underneath the CTA on a sliding tray behind the wash buffer. The waste container holds up to 900 AVs. The system counts used AVs. If 900 AVs were counted, the AV Waste button turns red and the CTA unit stops. It is recommended to empty the AV waste container before running the system.

Change the AV Waste Container

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the screen.

Select the AV Waste button at the CTA Supplies area.

Select Empty F2.

Open the CTA door (1).

Slide out the metal tray (7) to gain access to the waste container area.

AVs are collected into a red waste bag that fits into the metal waste container (8). Open the metal lid (9) and remove the red waste bag and cardboard insert. Discard the waste bag

according to laboratory procedures.

Place a new waste bag and a cardboard insert into the container.

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Install the metal lid so it fits over the container shroud.

Slide the metal tray back into position. Make sure that the tray is all the way back against the AV chute.

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Pre-Test Activities

Change AV Waste Container at CTA Unit

Close the CTA door.

Select OK to let the system know that the AV waste container is emptied. The system resets the count to 900.

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Pre-Test Activities

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Change the Wash Buffer at CTA Unit

A2 CTA DxC

Change the Wash Buffer at CTA Unit

The Wash Buffer is used to wash the CTA probes. The wash buffer assembly is located underneath the CTA unit. Refer to Figure 2.9. Visually observe the wash buffer level. The CTA Supply tab turns yellow if the wash buffer level is low (100 aliquots left). After the 100 aliquots are made, the tab turns red and the system stops. It is recommended to check the wash buffer before running the system.

Figure 2.9 Waste Container and Wash Buffer

1. CTA Door

2. CTA Power On/Off Switch

3. Sample Syringe

4. Wash Syringe

5. Auto-Gloss Bottle

Change the Wash Buffer at the CTA Unit

Refer to Figure 2.9. Open the door (1) underneath the CTA. The Wash Buffer Assembly (bottle

6. Wash Buffer Assembly

7. Metal Tray

8. Waste Container

9. Metal Lid

10. Peristaltic Drain Pump

and reservoir) (6) is mounted on a sliding tray (7).

Pull out the sliding tray.

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Mix the contents of the new wash buffer bottle by gently inverting the sealed bottle 3 or 4 times.

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Change the Wash Buffer at CTA Unit

Remove the cap and inner seal from new bottle.

Remove empty bottle.

Remove dispense cap assembly from empty bottle.

CAUTION

To avoid contaminating the wash buffer, DO NOT touch any part of the dispense cap assembly that enters the reservoir. Handle the dispense cap assembly only by the screw cap, not the nozzle.

Attach dispense cap assembly to new bottle.

Pre-Test Activities

Turn the new bottle upside down and place it into reservoir receptacle.

Push the sliding tray all the way in until it latches.

Close the CTA door.

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the screen.

Optional:

Type the lot number and expiration date in the

Supplies Status section of the screen.

CTA Wash Buffer Level field located on the CTA

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Pre-Test Activities

Change the Auto-Gloss Solution at CTA Unit

A2 CTA DxC

Change the Auto-Gloss Solution at CTA Unit

The Auto-Gloss solution is used to lubricate the piercing probe on the CTA unit. Refer to Figure 2.10.

Replace and Load the Auto-Gloss Solution

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the screen.

Select CTA Auto-Gloss.

Select Load F1. An Auto-Gloss data screen appears.

Open the CTA door (1). The Auto-Gloss bottle (5) is located on the bottom shelf.

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Figure 2.10 CTA Auto-Gloss

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Pre-Test Activities

Change the Auto-Gloss Solution at CTA Unit

1. CTA Door

2. CTA Power On/Off Switch

3. Sample Syringe

4. Wash Syringe

5. Auto-Gloss Bottle

Unfasten the cap and remove the old bottle.

Install the new Auto-Gloss bottle and tighten the cap. Use the DxC hand-held bar code reader

6. Wash Buffer Assembly

7. Metal Tray

8. Waste Container

9. Metal Lid

10. Peristaltic Drain Pump

(1) Figure 2.3, to scan the Auto-Gloss bottle. The data appears on the screen.

Select Done F10.

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Pre-Test Activities

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Check and Load Access Supplies and Reagents

A2 CTA DxC

Check and Load Access Supplies and Reagents

Select Rgts/Cal from the menu bar.

Select the Supplies tab on the Reagent/Calibration screen to view the supply status. Refer to

Figure 2.11. A supply highlighted in red indicates that the particular supply is low and requires

immediate attention. A supply highlighted in yellow indicates that the supply is getting low.

Select the Access tab to check the reagent status at the Access analyzer. A reagent supply highlighted in yellow indicates that the supply is getting low. A reagent highlighted in red

indicates that the particular reagent supply is low and requires immediate attention.

Figure 2.11 Supplies Screen at the DxC 600i Monitor

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Pre-Test Activities

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Check and Load Access Supplies and Reagents

Access supplies can also be checked from the Access Supplies screen (Figure 2.12) at the Access monitor. Select the

Figure 2.12 Access Supplies Screen at Access Monitor

F3 Supplies button on the Main menu to bring up this screen.

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Pre-Test Activities

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Load the Reaction Vessel (RV) Cartridges onto Access Analyzer

A2 CTA DxC

Load the Reaction Vessel (RV) Cartridges onto Access Analyzer

Reaction Vessels (RVs) are used to process immunoassay tests within the Access analyzer. RVs are packaged in a cartridge. Each cartridge holds 98 vessels. Three cartridges can be loaded at one time for a maximum capacity of 294 vessels. If the RV supply is getting low (<60 RVs), the Access system displays a yellow caution. If the RV supply is low (<28 RVs) the RV Supply icon turns red.

It is recommended to load RVs when the yellow caution displays. When the RV Supply icon turns red, the Access must be in Ready mode to load a cartridge.

Figure 2.13 Changing the RV Cartridge

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1. RV Supply Door

2. RV Cartridge

3. RV Load Door

4. RV Waste Bag Area

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Pre-Test Activities

Load the Reaction Vessel (RV) Cartridges onto Access Analyzer

Load the RV Cartridges

Select Supplies F3 from any Access screen.

Select Load RVs F4. The reaction vessel latch disengages.

CAUTION

Loading the RVs without selecting "Load RVs F4" may damage the analyzer.

Refer to Figure 2.13 for steps 3-6. Remove protective covering from the RV cartridge (2).

Open the RV supply door (1) at the front of the analyzer.

Open the RV load door (3) when prompted by the software.

Place the RV cartridge into RV supply area as shown.

Press down firmly on the RV load door to release the RVs from the spine.

Open the RV load door and remove the spine.

Close the RV load door.

Close the RV supply door.

Select Done F1.

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Pre-Test Activities

Change the RV Waste Bag at Access Analyzer

A2 CTA DxC

Change the RV Waste Bag at Access Analyzer

When the RV waste bag has room for 60 or fewer RVs, the RV Waste Bag button turns yellow at the Access and DxC 600i turns red and the system will not process samples. It is recommended to change the bag when the button turns yellow before processing samples.

Select Supplies F3 from any Access screen.

Supplies screen. When the RV waste bag becomes full, the Waste Bag button

Select Change RV Waste Bag F6.

Open the RV supply door (1). Unfold and expand the new RV waste bag. Refer to Figure 2.13.

Remove and seal the old bag.

Insert the new bag. Each bag has a plastic flange that fits into a slot. If the system is running, install the bag immediately.

CAUTION

If the system is running when you change the bag, the system may try to eject an RV when the plastic collar on the waste bag is blocking the ejection chute. This causes a jam. To prevent damaging the system, DO NOT push an RV that is sticking out from the ejection chute all the way back into the chute.

Close the RV supply door.

WARNING

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Dispose of waste bag according to proper laboratory procedures.

Select Done F1.

NOTE

RV Waste bag information is also displayed at the DxC 600i monitor.

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Change the Wash Buffer Bottle at Access Analyzer

A2 CTA DxC

Change the Wash Buffer Bottle at Access Analyzer

The wash buffer bottle, shown in Figure 2.14, may be changed at any time. If the Wash Buffer button turns red at the Access and DxC 600i until the wash buffer bottle is changed.

Figure 2.14 Changing the Wash Buffer Bottle

Supplies screen, the system will not schedule any new tests

Pre-Test Activities

1. Wash Buffer Bottle

2. Dispense Cap Assembly

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3. Reservoir Receptacle

4. Wash Buffer Reservoir

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Pre-Test Activities

Change the Wash Buffer Bottle at Access Analyzer

Change the Wash Buffer Bottle

Mix the contents of the new wash buffer bottle by gently inverting the sealed bottle 3 or 4 times.

Remove the cap and inner seal from the new bottle.

Remove the empty bottle.

Remove the dispense cap assembly from the empty bottle.

CAUTION

To avoid contaminating the wash buffer, DO NOT touch any part of the dispense cap assembly that enters the reservoir. Handle the dispense cap assembly only by the screw cap, not the nozzle.

Attach dispense cap assembly to the new bottle.

Turn the new bottle upside down and place it into the reservoir receptacle.

Select Rgts/Cal from the menu bar at the DxC 600i monitor.

Select the Supplies tab on the screen.

Optional:

Type the lot number and expiration date in the Supplies Status section of the screen.

Wash Buffer Level field located on the Access

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Change the Liquid Waste Bottle at Access Analyzer (Optional Waste Collection Feature)

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A2 CTA DxC

Change the Liquid Waste Bottle at Access Analyzer (Optional Waste Collection Feature)

The Liquid Waste bottle (shown in Figure 2.15) can be changed at any time. If the Liquid Waste button is red, the system will not schedule any new tests.

Figure 2.15 Changing the Liquid Waste Bottle

Pre-Test Activities

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1. Liquid Waste Bottle

2. Quick Disconnect

Change the Liquid Waste Bottle

Change the liquid waste bottle (1).

• If the system has stopped processing samples, — release the quick disconnects (2) from the full bottle and connect the disconnects to

the empty bottle.

• If the system is still processing samples, — leave the bottle cap attached to the quick disconnects — replace the full bottle with a clean bottle and attach the cap.

Decontaminate contents of full liquid waste bottle according to your laboratory protocol.

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Pre-Test Activities

Change the Liquid Waste Bottle at Access Analyzer (Optional Waste Collection Feature)

Dispose of liquid waste and rinse bottle thoroughly.

WARNING

Consider liquid waste potentially infectious. handle and dispose of liquid waste according to proper laboratory procedures.

Store a clean bottle for future use.

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Change the Substrate Bottle at Access Analyzer

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A2 CTA DxC

Change the Substrate Bottle at Access Analyzer

The Substrate icon turns yellow when the system can process 60 or fewer tests with the current supply of substrate. The icon turns red when the substrate bottle is empty. The system cannot start processing samples until you load a new bottle of substrate. The substrate bottle (shown in

Figure 2.16) can only be changed when the Access analyzer is in Ready mode.

Figure 2.16 Changing the Substrate Bottle

Pre-Test Activities

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1. Substrate Bottle In Use

2. Substrate Bottle Equilibrating to Room Temperature

CAUTION

Before changing the substrate, always wear powder free gloves so that the substrate does not become contaminated.

Change the Substrate Bottle

Select Supplies F3 from any Access screen.

Select Change Substrate F5.

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Pre-Test Activities

Change the Substrate Bottle at Access Analyzer

Scan the new, equilibrated substrate bottle using the Access hand-held bar code reader.

NOTE

Replace cap on new substrate bottle with cap from old substrate bottle.

Discard empty bottle. Equilibrate another new bottle at room temperature for at least 18 hours prior to use.

Select Done F1.

Select Yes F1. The system automatically primes the substrate lines.

Allow the substrate bottle to equilibrate at room temperature for at least 18 hours prior to use.

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Load a Reagent Pack onto Access Analyzer

A2 CTA DxC

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The Access Reagent Pack is loaded onto the Access Analyzer to run immunoassay tests. Refer to

Figure 2.17 for details.

Figure 2.17 Loading/Unloading a Reagent Pack

Pre-Test Activities

Load a Reagent Pack onto Access Analyzer

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1. Reagent Pack

2. Carousel

Load the Reagent Pack

Select Supplies F3 from any Access screen.

Select Load Reagent Pack F1.

Mix the reagent pack (1) by gentle inversion.

When prompted by the software, open the sample carousel cover and reagent carousel door. Insert the reagent pack at a downward angle and press down until it snaps in place. Refer to

Figure 2.17, view A. Then gently pull the pack back towards the outer rim of the carousel (2) to

ensure it is properly seated in place. Refer to Figure 2.17, view B.

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Pre-Test Activities

Load a Reagent Pack onto Access Analyzer

CAUTION

To prevent damage to the reagent pack, be sure it is properly seated in the reagent carousel.

CAUTION

Do not interchange used Access reagent packs between DxC 600i and: Standalone DxC 600i systems, Networked DxC 600i systems, Stand-alone Access 2 systems and Networked Access 2 systems.

If you reload a partially used Access reagent pack, it must be returned to the same stand-alone system (Access or DxC 600i) or Access workgroup (systems networked to each other) from which it was inventoried and removed. If loaded on a different stand-alone system or workgroup, it is treated as if it contains 50 tests, and invalid results may occur.

Enter the reagent pack bar code by scanning the reagent pack with the hand-held bar code reader, or by typing the characters above the reagent pack bar code in the barcode field.

Select Done F1.

Close the reagent carousel door and sample carousel cover.

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Pre-Test Activities

Load a Reagent Pack onto Access Analyzer

Unload the Reagent Pack

Select Supplies F3 from any Access screen.

Select the pack name to unload.

Select UnLoad Reagent Pack F2.

Open the sample carousel cover.

Open the reagent carousel door and remove the reagent pack in the presented carousel slot. Push the pack in towards the center of the carousel and lift the back of the pack.

Close reagent carousel door.

Close the sample carousel cover.

Select Done F1 when finished.

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Pre-Test Activities

Load a Reagent Pack onto Access Analyzer

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System Calibration

Introduction

System calibration is used to standardize the analysis of samples to existing conditions. Refer to the Synchron Clinical Systems Chemistry Information Sheets and the Access Immunoassay System Assay Manual for detailed information regarding such conditions. In general, system calibration is required when:

CHAPTER 3

System Calibration

• a new reagent is used (except when within lot calibration applies on DxC System)

• at recommended calibration frequency intervals

• indicated by control results

• after specified maintenance and diagnostic procedures

• after certain parts replacement

IMPORTANT

describe how to calibrate the DxC and Access analyzers under various conditions.

Calibration procedures must be conducted separately at each analyzer. The following tables

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System Calibration

A2 CTA DxC

Calibrate DxC Chemistries With Bar Code Labels

From the Rgts/Cal screen, check the Calibration Time Left column displayed in days:hours:minutes and the Cal Status column to see which chemistries require calibration.

Select Rgts/Cal from the menu bar.

Select the DxC tab on the calibration screen.

Select the chemistries to be calibrated. If necessary, use the up and down arrows to select more chemistries.

Select Cal F4.

Select List F5 to review the calibrator load list.

• Make sure the lot number on the calibrator bottle agrees with the lot number seen on the screen.

• Make sure the correct bar code labels are in the correct positions.

Place a calibrator bar code label (with the name of the calibrator to be used) on a 16 mm transport tube. Repeat for all calibrators.

Place calibrator into sample cups.

• For Aqua cals 1, 2, and 3, fill a 0.5 mL cup.

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Refer to Figure 3.1.

• Open the DxC 600i load area cover.

• Place the sample rack (1) onto DxC 600i load area with bar codes facing right.

• Press

Figure 3.1 DxC 600i Load Area

RUN (2).

System Calibration

1. Sample Rack

2. RUN Button

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System Calibration

A2 CTA DxC

Calibrate DxC Chemistries Using Assigned Calibrator Racks

From the Rgts/Cal screen, check the Calibration Time Left column displayed in days:hours:minutes and the Cal Status column to see which chemistries require calibration.

Select Rgts/Cal from the menu bar.

Select the DxC tab on the calibration screen.

Select the chemistries to be calibrated. If necessary, use the up and down arrows to select more chemistries.

Select Cal F4.

Select List F5 to review the calibrator load list. Make sure the lot number on the calibrator bottle is the same as the lot number on the screen.

Get the assigned calibrator racks listed on the screen and place the cups into assigned rack positions as shown on the load list.

Place calibrator into sample cups.

• For Aqua cals 1, 2, and 3, fill a 0.5 mL cup.

• All other calibrators need 3 drops of calibrator in a 0.5 mL cup.

Refer to Figure 3.1.

• Open the DxC 600i load area cover.

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• Place the sample rack (1) onto DxC 600i load area with bar codes facing right.

• Press RUN (2).

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A2 CTA DxC

Calibrate Access Chemistries (Assays)

This procedure is performed at the Access analyzer. Calibrate Access assays as follows in the procedure below:

System Calibration

IMPORTANT

than 20 µL per test, you must use Aliquot Vessel (AV) containers manually loaded in automation racks (1900 - 1999).

Select the Main menu at the Access monitor.

Select Sample Manager F1.

Select an off-board rack (X).

Type the rack ID (X) and press

Select Test Request F3.

Select Request Calibration F6.

For Access 2 Total bhCG, diluted bhCG and all Access 2 tests that use sample volumes of less

Enter

(

)

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Select calibration set.

Select OK F1. The system enters calibration set lot number, calibration levels, and a reagent pack lot number. The system also enters each calibrator level in subsequent sample positions.

Select Load Rack (X) F1.

Insert samples into rack and load the rack onto the Access sample carousel.

Select F1 Done.

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System Calibration

Select RUN.

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Calibration Override Function

The Calibration Override option allows the system to override a failed calibration and obtain results based on the failed calibration factors. Calibration Override is available only when an attempt to calibrate the chemistries has been previously made and failed, displaying the status Cal Failed. A chemistry with any other status, including Cal Required, cannot be overridden. The calibration can be overridden while the system status is Standby, Disabled or Running.

System Calibration

IMPORTANT

when a delay caused by calibration is unacceptable to the laboratory. The magnitude of error which is deemed acceptable when overriding a failed calibration is totally under the control of the laboratory. Therefore, the Override function should be used with caution.

Overriding a calibration is not usually justified. However, there may be an emergency situation

Override a Calibration for DxC

Override a Calibration

Select Rgts/Cal from the menu bar.

Select the DxC tab on the calibration screen.

Select the Chem position to override.

Select Options F6.

Select Calibration override from the Cal Options dialog box.

Remove Cal Overridden Status at DxC

The Cal Overridden status can only be removed by successfully recalibrating the chemistry or by selecting Chem Bypass. A flag indicating that a particular chemistry has been overridden appears in the Instrument Code area on the appropriate Summary or Patient Chartable Results report. Although a Cal Overridden status can be bypassed, the Cal Overridden flag is only removed by a successful calibration.

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System Calibration

Override a Calibration or Supply for Access

Refer to the following instructions to override an expired Access calibration or Access Substrate expiration status from DxC 600i monitor. The calibration override function does not apply to failed calibrations on the Access analyzer.

IMPORTANT

load area.

Select Rgts/Cal from the menu bar.

Select the Access or Supply tab.

If the Access tab was selected above, select the chemistry position. If Supply tab was selected above, select the Substrate.

Select OK F3 to override.

Calibration override for Access must be completed prior to loading samples on the DxC 600i

Remove Cal Overridden Status at Access

The Cal Overridden status can be removed by successfully recalibrating the chemistry. The overridden substrate can be removed by replacing the substrate bottle.

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System Calibration

A2 CTA DxC

Run QC Samples

This task is performed when your laboratory protocol indicates that control material should be analyzed. A daily analysis of at least two levels of control materials is highly recommended. In addition, these controls should be run with each new calibration, with each new lot of reagents, and after specific maintenance or troubleshooting activities.

When defining controls, Control IDs should be as descriptive as possible. Refer to the UniCel DxC Synchron Clinical Systems Instructions For Use manual for additional information about programming controls. The following procedures describe how to run control samples.

Run Control Samples With Bar Code Labels and Auto Generation of Control Enabled

When Auto Generation of Control is enabled, the automatic Multiple Cartridge option is available. With the Multiple Cartridge option enabled, the system automatically runs all cartridges onboard and runnable for any chemistries for an autogenerated control. To enable Multiple cartridge from the

Setup screen, scroll down and select 29 Auto Generation of Control.

If all tests programmed for an Auto Generated control ID do not complete testing (for example, reagent not onboard, calibration required, cal time exceeded, or disabled), the next time the control ID is loaded, all tests for the control Auto Generate and are run again.

Place bar-coded control sample(s) in rack(s). All tube bar code labels must be visible through the slots on the same side of the rack as the rack bar code label.

Place cups that contain QC material in bar code labeled tubes and place rack(s) in the DxC 600i load area.

Press RUN on the analyzer.

The instrument automatically runs chemistries that are:

• Defined for the control.

• Loaded and calibrated.

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• Contain sufficient volume to run the controls.

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System Calibration

Run Manually Programmed Control Samples

If a control ID that was manually programmed does not complete testing, the next time the control ID is loaded, only the incomplete tests will run. A Manually programmed control ID that is incomplete must be manually cleared before reloading the sample in order to Auto Generate all tests for the control.

NOTE

In Manual QC Programming, the system automatically runs the oldest cartridge onboard for the selected chemistry. Specific cartridges (other than default) may also be selected. To access duplicate or specific cartridges, select Rgt Cart F8. Then select the desired cartridges and select OK.

Select Samples from the menu bar.

Clear the QC sample ID to be used.

• Select

• Type the QC sample ID in the

• Select

Select Control F5 and select the control name from the list.

• Select the pull-down menu next to the

• Type the QC Sample ID in the

The lot number on the Control bottle.

Clear F1.

Sample ID(s) field. OK. OK to confirm.

Control ID field to select from predefined Control IDs.

Sample ID field.

Program Control screen opens. Make sure the lot number on the screen is the same as the

3-10

Type the rack/position number.

Select chemistries to be run.

Select Save F10 to save the control programming and return to the Program Sample screen.

Pour control material into sample cups.

Load racks onto the DxC 600i load area.

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Press RUN on the analyzer.

System Calibration

IMPORTANT

required, cal time exceeded or disabled), the next time the control ID is loaded, only the incomplete tests will run. To run all chemistries, the control ID must be cleared manually before reloading the sample for Auto Generation of Controls.

Run QC Samples at Access Analyzer

Refer to Access 2 Immunoassay System Operator's Guide for instructions. QC samples programmed and processed at the Access analyzer are not uploaded to the DxC QC database.

If all tests programmed for the control do not complete testing (for example: calibration

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System Calibration

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Sample Programming and Processing

Introduction

Sample programming identifies the samples, selects tests to run, describes samples, and designates how to run samples. Samples are programmed through a host computer such as a Laboratory Information System (LIS), or directly from the DxC 600i System. The minimum information required to save a sample program on the DxC 600i System includes:

CHAPTER 4

• a sample ID

• and one test selection

Test selections are assigned by 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. When programmed, samples are placed onto the DxC 600i load area. The operator presses the RUN button to start the test process. A complete programming tree is located in APPENDIX A,

Supplementary DxC 600i Information.

Access manual programming overrides programming done at the DxC.

If the System Configuration screen is accessed, press the leave the screen. Pressing the

Any sample manually loaded on the Access analyzer (such as Access calibrators) causes the CTA to stop transferring aliquots to the Access analyzer. The CTA resumes transferring aliquots to the Access sample carousel when the Access analyzer has completed aspirating all of the manually loaded samples. Samples manually loaded at the Access must be removed by the operator after aspiration is complete. Samples transferred by the CTA are removed by the CTA.

Cancel button insures that the current IP addresses are retained.

Cancel button instead of the OK button to

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Sample Programming and Processing

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Sample Programming and Processing

DxC 600i Setup Options

The following Setup Options should be configured before samples are processed on the DxC 600i System. These setup options include Chemistry Configuration, Units/Precision, Default Sample Type, Reflex Testing, Access Priority, Obstruction Detection and Correction, Reference Ranges (Gray Zone), and Special Calculations. Setup options are accessed through the as shown in Figure 4.1.

Figure 4.1 System Setup Screen

System Setup screen

IMPORTANT Chemistry Configuration and Units/Precision must be setup identically at the DxC and Access

analyzers.

Access LIS Configuration

On the DxC 600i System, the Access LIS Configuration only permits the selection of the "By Test" mode in the LIS

Send field. The "By Test" mode sends test results to the DxC console as soon as they

are available.

However, the DxC 600i System defaults to hold all test results until the sample is complete. In this configuration, the system sends test results to the LIS in a single transmission. To change this, select an Immediate Report option on the

Immediate Report screen under System Setup. If you select an

Immediate Report option, designated results for the sample are sent as they are complete, and when the sample is complete.

Immediate Report of Access 2 by Test

If you select Immediate Report of Access 2 by Test, each individual Access assay result is sent to the Host and/or Printer as soon as it becomes available.

If you do not select or Printer in a single transmission when all Access test results for the sample are complete.

Immediate Report of Access 2 by Test, the Access test results are sent to the Host

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Chemistry Configuration

The Chemistry Configuration function accommodates the installation of desired tests from a comprehensive list of available chemistries. Of the total tests available, 180 chemistries/ immunoassays 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.

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

Sample Programming and Processing

Configure a Beckman Coulter Chemistry

The chemistry menu, available in sample programming, quality control, panel definition and other screens, is defined by the user.

Define Beckman Coulter Chemistries

Select Setup from the menu bar.

Select 2 Chemistry Configuration/Sample Type.

2 in the Option Number field.

Type

Select Configured chemistry position number. (Configured chemistry position number refers to how the chemistries are displayed throughout the system and appear on the reports.)

If the Beckman Coulter chemistry acronym is known (e.g., CO2), type the acronym in the blank position.

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Select Chems F1 to view a comprehensive listing of the available Beckman Coulter tests and the appropriate test acronyms. Only those chemistries which appear on the list can be configured.

Select the Beckman Coulter chemistry from the Chemistries list number. The Chemisty acronym appears in the blank position.

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Sample Programming and Processing

Repeat Steps 3-6 until all applicable chemistries are placed in the desired positions. Any positions left blank appear the same on all menu displays.

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Units/Precision

The Units/Precision option is used to select the units and the number of decimal places for each result. If the units are altered, all features affected by this change, such as reference ranges and calibration values, automatically converts to match the new units. Units can only be selected when the DxC 600i System is in the Standby, Stopped, Startup, Instrument Down, or Homing mode.

Select Chemistry Units or Precision Values

Select Setup from the menu bar.

Sample Programming and Processing

Select 14 Units/Precision.

14 in the Option Number field.

Type

Select the pull-down menu below the Units column and select the desired units for the chemistry.

Select the pull-down menu below the Precision column and select the desired precision for the chemistry.

Repeat Steps 3-4 until all of the desired units and precision have been selected.

Select Done F10 when complete.

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Sample Programming and Processing

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Sample Programming and Processing

Figure 4.2 Units/Precision Screen

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Default Sample Type

The default sample type option allows for the definition of the default sample type for all programmed samples. The sample type may be changed for individual samples within the sample programming function.

Set the Default Sample Type

Select Setup from the menu bar.

Select 2 Chemistry Configuration/Sample Type.

Sample Programming and Processing

OR Type

2 in the Options Number field.

Select the pull-down menu next to the Default Sample Type field.

Select a sample type and select Done F10.

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DxC 600i Reflex Testing

Access-to-Access Reflex Testing Defined at Access Analyzer:

The Access analyzer has a reflex test feature that can be used in a DxC 600i configuration. The operator defines reflex testing rules at the Access analyzer. When a sample is programmed for an Access test that could trigger a reflex text, the CTA recognizes that a reflex test may be required. As a result, additional sample volume is aliquotted for that test up to the maximum volume allowed in an AV.

An AV holds a maximum of 450 µL. Rarely, the volume needed to complete Access testing for a sample exceeds this maximum. In this event, the sample is marked as incomplete. To complete the testing, run the sample again.

The AV remains on the Access analyzer until it is determined if it needs to perform the reflex test. At that point, the Access analyzer performs the reflex test or discards the AV. Refer to the Access 2 Immunoassay System Operator’s Guide for further details.

Reflex Testing Defined at the DL2000 or LIS:

Reflex rules are defined externally to the DxC 600i at the DL2000 Data Manager, or at the Laboratory Information System (LIS). The operator has the option of setting up DxC to DxC, DxC to Access, or Access to Access to run reflex tests. Refer to the DL2000 Operations Manual or your LIS Operations Manual for further details.

Setup the DxC 600i System to Setup the Reflex Test on the DL2000 or LIS

Select Setup from the menu bar.

Select 30 Access 2 Priority/Reflex Test Setup.

OR Type

30 in the Option Number field.

Check the box next to the chemistry which triggers the reflex test defined at DL2000 or LIS.

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Done F10.

Select

Select 20 Host Communication.

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Access 2 Priority / Reflex Test Setup

Select the Requery box on the screen and Done F10.

Figure 4.3 Reflex Test Setup

Sample Programming and Processing

The DxC 600i automatically recirculates the sample racks that contain a sample programmed with a reflex conditioned test. When the initial test is completed, the DL2000 or LIS determines if the reflex test needs to be performed. The DxC 600i queries the DL2000 or LIS again for the reflex test. If the DxC 600i receives the reflex test programming, the reflex test is performed for that sample. If the DxC 600i does not receive additional tests for that sample, the rack is offloaded. If the sample becomes INCOMPLETE, it is offloaded and no reflex test is performed.

NOTE

When the DxC 600i re-queries DL2000 or the LIS, the prior test programming for the sample is deleted

from the DxC console and CANNOT be recalled. These results should be available at DL2000 or LIS.

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Access Priority Option

The Access Priority option allows programmed samples to be processed on the Access analyzer first.

Setup the Access Priority Option

Select Setup from the menu bar.

Select 30 Access 2 Priority/Reflex Test Setup.

30 in the Option Number field.

Type

Select the Access Priority check box on the screen and Done F10.

IMPORTANT

programmed for general chemistries and immunoassays are not processed.

If the Access Priority Option is enabled, and the Access is not operational, samples

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Obstruction Detection and Correction (ODC)

A2 CTA DxC

The CTA unit and the DxC analyzer use Obstruction Detection and Correction to detect the difference between a normal fluid sample and a clotted sample. This is accomplished by measuring the pressure when a sample is aspirated. If the pressure exceeds the normal range, the sample is flagged. Obstruction Detection for the CTA and the DxC function independently of each other. For detailed information on the Obstruction Detection for the DxC analyzer, refer to the UniCel DxC Synchron Clinical Systems Instructions For Use manual.

The system uses Obstruction Detection on every open or closed sample tube. There must be sufficient volume in the sample tube for the requested tests. If the sample tube has insufficient volume, the probe may get too close to the bottom of the sample tube and cause Obstruction Detection messages.

Sample Programming and Processing

If the CTA detects a complete blockage of the sample probe, an Obstruction Detection message is displayed indicating which rack and sample is involved. An Obstruction Detection message on the CTA causes the CTA to go to Stopped. The message: "Unrecovered CTA Sample Probe Obstruction 0x07000809" indicates that the CTA ODC requires operator intervention.

Remove an Obstruction Detection Error at the CTA

Verify that the CTA is Stopped. If not, press the CTA STOP button.

Follow the procedure for flushing the CTA probe in CHAPTER 6, Maintenance Procedures, "CTA

Maintenance (As-Needed)".

CAUTION

The procedure for flushing the CTA probe is not recommended for removing gel from the Aliquot Probe. Replace the probe if gel is present, or if the clot cannot be removed.

When the obstruction is removed, unload the racks with the suspect samples.

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Inspect the samples for clots. Remove clots, if present, and centrifuge the samples again.

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Sample Programming and Processing

Load the samples onto the DxC 600i load area and press RUN to process the samples.

IMPORTANT

when the CTA is operational (if within 3 hours).

IMPORTANT If the obstruction in the CTA Aliquot probe cannot be removed, or if samples need to be

processed immediately, process samples as follows in the procedure below.

What to do if an Obstruction Detection Error at the CTA Cannot be Removed

Verify that the CTA is Stopped. If not, press the CTA STOP button.

Open the door below the CTA, and locate the CTA Sample Syringe (the syringe on the right).

Obtain the Probe Cleaning Tubing Assembly, PN 756613.

Unscrew the threaded fitting on the right side of the Sample syringe. Place the removed fitting and tubing in a beaker placed next to the Sample syringe.

Connect the black fitting of the Probe Cleaning Tubing Assembly to the right side of the Sample syringe.

DO NOT remove aliquotted AVs if present in the AV Queue area. The AVs are processed

Close the CTA canopy and Home the CTA.

When the CTA is at Standby, remove the fitting from the Probe Cleaning assembly and securely reattach the threaded fitting for the Sample syringe. Tighten the fitting finger tight and one-

fourth turn to secure.

Off load all racks on the CTA Sample Carousel using the Instr Cmd icon. Then select 8 Unload All.

An Unload All Racks screen appears. Remove all racks from the DxC 600i load area and select 2

CTA

Press RUN at the DxC 600i load area. The CTA moves all AV’s presently aliquotted in the AV Queue area onto Access for processing.

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Sample Programming and Processing

To continue sample processing, refer to the Independent Mode procedure in APPENDIX A,

Supplementary DxC 600i Information of this manual.

Figure 4.4 Obstruction Detection Screen

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Special Calculations

The Special Calculations option provides a means of selecting predefined calculations or operatordefined calculations that are reported with each sample. The system provides capability of 40 calculations. The pre-programmed special calculations for DxC cannot be modified or deleted from the system. Additional calculations may be defined and/or modified by the operator. The selected calculations are reported only if the appropriate chemistries/assays for the equation are programmed and run for a given sample ID. While the calculations may be viewed at any time, the system status must be Standby, Stopped, Startup, Instrument Down, or Homing to program or modify special calculations. The default for predefined and operator defined calculations is disabled.

IMPORTANT

chemistry acronyms.

To define special calculations for Access assays at the DxC 600i monitor, use DxC 600i

IMPORTANT The predefined Free Thyroxine calculation for DxC is not equal to Free Thyroxine Index (FTI)

calculation (derived results) from Access.

NOTE If you have both CO

You must create a user-defined special calculation for CO

If you have only CO calculation for CO

and CO2E loaded on your system, the Anion Gap special calculation uses CO2.

E loaded on your system, you must create a user-defined Anion Gap special

Enable or View a Predefined Special Calculation

Select Setup from the menu bar.

Select 12 Special Calculations.

OR Type

12 in the Option Number field.

Select the check box beside the desired predefined special calculation to enable or disable.

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To view a predefined special calculation, select the calculation, then select View F1.

Select Cancel to exit the view screen.

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Beckman Coulter UniCel DxC 600i User guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Instructions For Use

Revision History

Safety Notice

Contents

Introduction

System Description

Introduction

CHAPTER 1

System Description

Shipping Damage

Specifications

Instrument and System Supplemental Specifications

Version Information

System Components

DxC Analyzer

Access Analyzer

Closed Tube Aliquotter (CTA) Unit

Theory of Operation

Access Functional Differences

Operator Control Devices

Access Online Help Feature

DxC 600i Main Menu Features

Host Communication Status Bar

Access Event Log Symbol

Main Operating Screens

System Monitoring

System Operating Conditions

Sample Status

Test Result Errors

CTA Event Codes

Access Codes Converted to DxC Codes for DxC 600i Reporting

Test Reports

Recalling Test Results

Introduction

CHAPTER 2

Pre-Test Activities

Prepare Test Samples

Check and Load Supplies at DxC Analyzer

Load or Unload MC Reagents

Refill the No Foam Container

Load/Unload CC Cartridges at DxC Analyzer

Check and Load Supplies at CTA Unit

Change AV Waste Container at CTA Unit

Change the Wash Buffer at CTA Unit

Change the Auto-Gloss Solution at CTA Unit

Check and Load Access Supplies and Reagents

Load the Reaction Vessel (RV) Cartridges onto Access Analyzer

Change the RV Waste Bag at Access Analyzer

Change the Wash Buffer Bottle at Access Analyzer

Change the Liquid Waste Bottle at Access Analyzer (Optional Waste Collection Feature)

Change the Substrate Bottle at Access Analyzer

Load a Reagent Pack onto Access Analyzer

System Calibration

Introduction

CHAPTER 3

System Calibration

Calibrate DxC Chemistries With Bar Code Labels

Calibrate DxC Chemistries Using Assigned Calibrator Racks

Calibrate Access Chemistries (Assays)

Calibration Override Function

Override a Calibration for DxC

Remove Cal Overridden Status at DxC

Override a Calibration or Supply for Access

Remove Cal Overridden Status at Access

Run QC Samples

Run Control Samples With Bar Code Labels and Auto Generation of Control Enabled

Run Manually Programmed Control Samples

Sample Programming and Processing

Sample Programming and Processing

Introduction

CHAPTER 4

DxC 600i Setup Options

Chemistry Configuration

Units/Precision

Default Sample Type

DxC 600i Reflex Testing