Abbott CELL-DYN 3200 System Operator's Manual

CELL-DYN

®

3200 System Operator’s Manual

i

9140181K—July 2002

Foreword

We welcome you to the role of Operator of the CELL-DYN 3200 System. Using

state-of-the-art technology, we have designed your instrument to function

consistently and dependably on a day-to-day basis.

The CELL-DYN 3200 System is backed by dedicated professionals who excel in

engineering, training, and technical expertise. As you are a valued customer, we

will teach you how to operate, maintain, and troubleshoot your system.

For continuing service, we also provide telephone technical assistance should you

need additional information or assistance in diagnosing a problem. This service is

available 7 days a week, 24 hours a day in the United States.

If a problem should arise that cannot be resolved by telephone, on-site support is

offered by Abbott’s Field Service Representatives. Our Field Service

Representatives are extensively trained in all aspects of Abbott instrumentation,

which assures proficiency in diagnosing, isolating, and correcting problems.

Abbott Laboratories is dedicated to manufacturing the highest quality, most

reliable instrumentation available. We look forward to serving your needs in any

way possible.

Customer Support

United States: 1 (800) CELL DYN or 1 (800) 235-5396

Abbott Diagnostics Customer Support Center:

200 Abbott Park Road

Abbott Park, Il 60064

Canada: 1 (800) 387-8378

For customers outside the U.S., call your local Hematology Customer Support

Representative.

Intended Use

The CELL-DYN 3200 is a multiparameter hematology analyzer designed for in

vitro diagnostic use in clinical laboratories.

Proprietary Statement

The entire contents copyrighted 1995, 1998, 1999, and 2001 by Abbott

Laboratories. Abbott Laboratories’ software programs are protected by copyright.

All rights are reserved. The software was developed solely for use with Abbott

Laboratories equipment and for in vitro diagnostic applications as specified in the

operating instructions. No part of this document may be reproduced, stored, or

transmitted in any form or by any means (electronic, mechanical, photocopied,

recorded, or otherwise) without the prior written permission of Abbott

Laboratories.

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Patent Statement

The following U.S. Patents are relevant to the CELL-DYN 3200 Instrument:

5,017,497; 5,378,633; 5,510,267; and 5,733,784.

Instrument Disclaimer

All operating instructions must be followed. In no event shall Abbott be

responsible for failures, errors, or other liabilities resulting from a customer’s

noncompliance with the procedures and precautions outlined herein.

Pictorial Disclaimer

The sample printouts/screens/graphics contained in this manual are for information

and illustration purposes only. Abbott Laboratories makes no representations or

warranties about the accuracy and reliability of the information on the printouts/

screens/graphics, and this information is not to be used for clinical or maintenance

evaluation.

Abbott Instrument Warranty

Abbott Laboratories warrants CELL-DYN Instruments sold by Abbott Sales

Representatives (the “Instrument”) to be free from defects in workmanship and

materials during normal use by the original purchaser. This warranty shall continue

for a period of one (1) year, commencing twenty-one (21) days from date of

shipment to the original purchaser, or until title is transferred from the original

purchaser, whichever occurs first (the “Warranty Period”).

If any defects occur during the Warranty Period, contact your Abbott Hematology

Customer Support Center immediately and be prepared to furnish pertinent details

concerning the defect, the Instrument model number, and the serial number.

Abbott’s Warranty coverage limits are as follows:

1. Abbott Hematology Customer Support Center: 24 hours per day, 7 days per

week phone support in the United States.

2. Field Service Representative support: 8:30

A.M.

to 5:00

P.M.

Monday through

Friday (excluding all Abbott-observed holidays).

3. Any on-site service performed at other times and all service required to

correct defects or malfunctions not covered by this Warranty (as noted in the

paragraph below) will be billed at Abbott’s labor rates then in effect.

This Warranty does not cover defects or malfunctions which:

1. Are not reported to Abbott during the Warranty Period and within one week

of occurrence.

2. Result from chemical decomposition or corrosion.

3. Are caused by customer or third party abuse, misuse, or negligence, or by

failure to comply with any requirement or instruction contained in the

applicable Abbott Operator’s Manual.

4. Result from maintenance, repair, or modification performed without Abbott’s

authorization.

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3200 System Operator’s Manual

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9140181K—July 2002

Abbott’s liability for all matters arising from the supply, installation, use, repair,

and maintenance of the Instrument, whether arising under this Warranty or

otherwise, shall be limited solely to the repair or (at Abbott’s sole discretion)

replacement of the Instrument or of components thereof. In no event shall Abbott

be liable for injuries sustained by third parties, incidental or consequential

damages, or lost profits. Replaced parts shall become the property of Abbott

Laboratories.

THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT

LABORATORIES REGARDING THE INSTRUMENT, AND ABBOTT

SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR

IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF

MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.

The CELL-DYN 3200 Series Hematology Systems are manufactured by Abbott

Diagnostics, Abbott Laboratories, at 5440 Patrick Henry Drive, Santa Clara, CA

95054, U.S.A. Please direct all inquiries concerning information in this manual to

the foregoing address.

NOTE: Direct all inquiries regarding equipment problems to the Abbott

Hematology Customer Support Center. (U.S. customers only.)

Regulatory and Safety Agency Approvals

UL1262 Approved

CSA 22.2 # 151 Approved

IEC 1010-1 Approved

In Vitro Diagnostic Directive 98/79/EC

Legal Manufacturer Abbott Laboratories

Abbott Park, Il 60064 US

Authorized Representative ABBOTT

Max-Planck-Ring 2

65205 Wiebaden

Delkenheim, Germany

iv

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3200 System Operator’s Manual

9140181K—July 2002

Trademark Statements

BJC-600e is a trademark of Canon Inc.

Canon is a registered trademark of Canon Inc.

CELL-DYN is a registered trademark of Abbott Laboratories.

CELL-DYN HemCal is a registered trademark of Abbott Laboratories.

Epson is a registered trademark of Seiko Epson Inc.

Hemogard is a registered trademark of Becton Dickinson and Company.

MAPSS is a trademark of Abbott Laboratories.

MICROLINE is a registered trademark of Oki America, Inc.

Millipore is a registered trademark of Millipore Corporation.

OKIDATA is a registered trademark of Oki America, Inc.

Retic-RITE is a registered trademark of Abbott Laboratories.

Sarstedt is a registered trademark of Walter Sarstedt Gerate, a German

Company.

Technicon H

•

3 is a registered trademark of Miles Inc.

TEFLON is a registered trademark of E.I. DuPont de Nemours Co., Inc.

TYGON is a registered trademark of Norton Performance Plastics.

VACUTAINER is a registered trademark of Becton Dickinson and

Company.

VenojectII is a registered trademark of Terumo Medical Company.

Westgard is a registered trademark of Westgard Quality Corporation.

CELL-DYN

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3200 System Operator’s Manual

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9140181K—July 2002

Symbols

The symbols listed below are used on CELL-DYN labeling, including the

instrument, reagents, calibrators, controls, and this manual. Please note that

Warning and Caution symbols and statements are in this manual in Section 8:

Hazards.

Instrument/Power related

Alternating Current

Input

Power

Busy

Pressure 1

Communications Port 1 Pressure 2

Communications Port 2 Pressure 3

Fault Ready

Frequency Revision

Fuse

Serial number

Fuses Service disk

High Speed Serial Link

Set-Up disk

Installation Disk

Shear Valve

Keyboard Touch

Line frequency select

Trap

Line Voltage Vacuum 1

Line Voltage Select

Video Graphics Adapter

First Parallel Printer

Port

Vent

Second Parallel Printer

Port

Waste

Maximum power Waste sensor

Model number

Y-Valve

Peristaltic Pump

$&,1387 32:(5

%86< 35(66

&20 35(66

&20 35(66

)$8/7 5($'<

)5(48(1&< 5(9

)86( 61

)86(6 6(59,&(',6.

+66/ 6(783',6.

,167$//$7,21',6. 6+($59$/9(

.(<%2$5' 728&+

/,1()5(46(/(&7 75$3

/,1(92/7$*( 9$&

/,1(92/7$*(6(/(&7 9*$

/37 9(17

/37 :$67(

0$;32:(5 :$67(6(1625

02'(/ <9$/9(

3(5, 67$/7 ,&3803

vi

CELL-DYN

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3200 System Operator’s Manual

9140181K—July 2002

Reagent related

Cyanide-Free Hemoglobin/Nucleated Optical Count Lyse

Diluent

Diluent/Sheath

Enzymatic Cleaner Concentrate

Expiration Date

Hemoglobin

Hemoglobin Lyse

Lot Number

Red Blood Cell

Sheath

Storage temperature. (Example shows “Store at 2º–8ºC”)

White Blood Cell

White Blood Cell Lyse

Calibrator/Control related

Control Assay

Whole Blood Calibrator

Whole Blood Control

Whole Blood Control, High

Whole Blood Control, Low

Whole Blood Control, Normal

&1)5((+*%12&/<6(

',/8(17

',/8(176+($7+

(1=<0$7,&&/($1(5&21&(175$7(

+(02*/2%,1

+*%

+*%/<6(

/27

5%&

6+($7+

8

o

C

2

o

C

:%&

:%&/<6(

&21752/$66$<

:+2/(%/22'&$/,%5$725

:+2/(%/22'&21752/

:%&21752/+

:%&21752//

:%&21752/1

CELL-DYN

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3200 System Operator’s Manual

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9140181K—July 2002

Miscellaneous

Authorized Representative

Consult instructions for use

Date of Manufacture

For In Vitro Diagnostic Use

Legal Manufacturer

List Number

(&5(3

,9'

5()

viii

CELL-DYN

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3200 System Operator’s Manual

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Instrument Labeling

The following labels are affixed to the CELL-DYN 3200 System:

Current CELL-DYN customer’s instruments are CE Marked to the

European Electro-Magnetic Compliance (EMC) and Low-Voltage

Directives and have the following labels:

Laser Label, Front Panel

Laser Label, Rear Panel

Serial Number Label, Rear Panel

AVOID DIRECT EXPOSURE TO BEAM.

NICHT DIREKT IN DEN LASERSTRAHL BLICKEN.

EVITER TOUTE EXPOSITION DIRECTE

AU FAISCEAU LASER.

NO SE EXPONGA DIRECTAMENTE AL RAYO LASER.

EVITARE OGNI ESPOSIZIONE DIRETTAAL RAGGIO.

LASER LIGHT WHEN OPEN.

BEI OFFENER ABDECKUNG TRITT

LASERSTRAHL AUS.

RAYON LASER SI OUVERT.

RADIACION LASER SI SE ABRE.

LUCE LASER SE APERTO.

DANGER

GEFAHR DANGER

PELIGRO PERICOLO

PN 9230701D

Class l Laser Product

per

lEC 825-1[1993]

PN 9230702A

ABBOTT DIAGNOSTICS

A wholly owned subsidiary of Abbott Laboratories

Abbott Park IL. 60064

THIS PRODUCT CONFORMS TO

THE APPLICABLE REQUIREMENTS

OF 21 CFR SUBCHAPTER J

AT THE DATE OF MANUFACTURE

MANUFACTURED DATE

MODEL NO.

SERIAL NO.

LIST NO. REV

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3200 System Operator’s Manual

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9140181K—July 2002

Voltage Label, Rear Panel

CE Label

Solution Container Label, Rear Panel

WARNING

WARNUNG

MISE EN GARDE

ADVERTENCIA

AVVERTENZA

: SET FOR 120 VOLTS

When operation at other line voltage is required, refer to operation manual for detailed instructions.

: FUER 120 VOLT EINGESTELLT

Ist der Betrieb mit einer anderen Netzspannung erforderlich, entnehmen Sie die genauen

Anweisungen der Bedienungsanleitung.

: PARAMETRE POUR UTILISATION SUR 120 VOLTS

Si une utilisation à une tension de réseau différente est requise, reportez-vous au Manuel

Technique pour de plus amples informations.

: CONFIGURADO PARA 120 VOLTIOS

Si se necesita otra tensión diferente a la indicada, consulte el Manual de Operaciones para

instrucciones más detalladas.

: CONFIGURATO PER 120 VOLT

Se la tensione è di voltaggio diverso, fare riferimento alle istruzioni dettagliate nel Manuale di

Impiego.

PN 9230003

CAUTION: DO NOT HANDLE

SOLUTION CONTAINER

UNLESS PROPERLY

PROTECTED. REFER TO

OPERATOR’S MANUAL FOR

INSTALLATION PROCEDURE.

PN 9230334

x

CELL-DYN

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3200 System Operator’s Manual

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New CELL-DYN customer’s instruments are CE Marked to the European

In Vitro Diagnostic Directive, which encompasses the requirements of the

EMC and Safety Directives, and have the following labels:

Laser Label, Front Panel

Laser Label, Rear Panel

Serial Number Label, Rear Panel

CAUTION –

CLASS 3B LASER LIGHT WHEN OPEN.

AVOID EXPOSURE TO BEAM.

PN 9230701

CLASS 1 LASER PRODUCT

PN 9230702

ABBOTT DIAGNOSTICS DIVISION

Abbott Laboratories

Abbott Park IL, 60064 USA

THIS PRODUCT CONFORMS TO

THE APPLICABLE REQUIREMENTS

OF 21 CFR SUBCHAPTER J AT THE DATE

OF MANUFACTURE

DATE OF MANUFACTURE

MADE IN U.S.A. PN 9230308 REV G

CELL-DYN

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3200 System Operator’s Manual

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9140181K—July 2002

CE Mark Label, Rear Panel

Voltage Label, Rear Panel

Solution Container Label, Rear Panel

NOTE: The most current representation of these labels will be depicted in

graphics contained in this manual.

ABBOTT

Max-Planck-Ring 2

65205 Wiesbaden

Germany

+49-6122-580

ABBOTT LABORATORIES

Abbott Park, IL 60064 USA

PN 9230751

A

WARNING: SET FOR 120 VOLTS

When operation at other line voltage is required,

refer to Operator’s Manual for detailed instructions.

PN 9230003

E

CAUTION: DO NOT HANDLE

SOLUTION CONTAINER

UNLESS PROPERLY

PROTECTED. REFER TO

OPERATOR’S MANUAL FOR

INSTALLATION PROCEDURE.

PN 9230334

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NOTES

CELL-DYN

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3200 System Operator’s Manual

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9140181K—July 2002

How to Use This Manual

Overview

This Operator’s Manual contains complete instructions for using and maintaining

the CELL-DYN 3200 System.

This manual was designed to fill several needs, from providing step-by-step

operating instructions to listing accessory part numbers. You will find it a valuable

aid as you learn to use the system and an essential reference thereafter.

A basic principle of effective learning is to proceed from the general to the specific.

That is the way the material in this manual is presented. And that is how we wish

to present the manual to you.

The first and most important step is to get acquainted with the Master Table of

Contents. For this reason, we start with a brief overview to show you how the

information is organized in sections.

After that, we explain how the manual is physically designed to help you locate

desired information quickly and easily.

Finally, we discuss different ways material is presented for different purposes and

explain various icons that identify specialized types of information in the text.

Please take the time to read and understand this brief preparatory section.

Manual Organization

Front Matter

The pages in front of the Master Table of Contents contain two main sections: A

Foreword that includes customer support and intended use information, and How

to Use This Manual that includes a description of the organization. These pages

also contain proprietary, warranty, trademark statements, and Manual Revision and

Status Logs.

Section 1. Use or Function

This section provides an overall description of the system and its components. It

names the major system components and tells what they are used for.

Section 2. Installation Procedures and Special Requirements

This section provides instructions for installing the CELL-DYN 3200 system. It

explains proper location, installation, setup, and configuration to meet your

laboratory’s specific needs.

Section 3. Principles of Operation

This section explains the principles behind the system’s operation. It describes

what the system measures and how those measurements are made. It also explains

the translation of those measurements into useful data and reports for the user.

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Section 4. Performance Characteristics and Specifications

This section contains useful details on the dimensions of the instrument, proper

operating environment, and performance specifications.

Section 5. Operating Instructions

This section contains detailed instructions to set up the instrument and explains the

procedures for daily start-up and shutdown, sample collection and handling,

routine operation of the instrument, sample analysis, and use of the data log.

Section 6. Calibration Procedures

This section takes you step by step through the calibration process. It discusses

calibration materials, guidelines, and methods, including troubleshooting

procedures and corrective action.

Section 7. Operational Precautions and Limitations

This section contains a summary of known factors that may adversely affect the

proper operation of the instrument or the quality of the output.

Section 8. Hazards

This section covers possible hazards arising from the operation of the instrument,

as well as decontamination and waste handling procedures.

Section 9. Service and Maintenance

This section discusses routine maintenance and cleaning on a daily, weekly,

monthly, and “as needed” basis. Also included are detailed instructions for

removing, cleaning, and replacing various components to ensure proper system

performance.

Section 10. Troubleshooting and Diagnostics

This section discusses the diagnostics capability of the instrument. It contains a

troubleshooting guide to help users identify probable causes of a system

malfunction or of suspect data, and to suggest the proper corrective action.

Section 11. Quality Control

This section covers the proper mixing, handling, and running of control material,

setting up QC files and using the QC capabilities of the instrument, and setting up

and using the X-B Analysis Program. It also provides a review of the Westgard

®

Rules.

Section 12. Printers

This section reviews the setup and use of printers for graphics output and ticket

printing.

Section 13. Sample Loader

This section includes material from all the previous sections which pertains

specifically to the installation, operation, and maintenance of the Sample Loader.

CELL-DYN

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9140181K—July 2002

Section 14. Reticulocyte Package

This section contains detailed information on how to turn ON the reticulocyte

package, set up retic QC and retic patient limits, and prepare and process retic

samples.

Appendices

Appendix A describes how to use bar codes on the CELL-DYN 3200 and contains

information on bar code types and bar code labels.

Appendix B lists the part numbers of components, accessories, controls, reagents,

and consumables associated with the CELL-DYN 3200 System for user

convenience when placing orders.

Index

This section contains an alphabetical listing of subject matter to help users quickly

locate specific information about the system.

Manual Construction

The physical construction of the manual supports its sectional organization.

Master Table of Contents

The Master Table of Contents at the beginning of this manual lists each section and

its subsections.

Section Separators

A large separator tab marks the start of each section.

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Text Conventions Used in This Manual

The following list summarizes the text conventions that are used in this manual:

Soft Keys (Screen Label Keys)

Screen labels are menu keys displayed at the bottom of the display screen. Directly

below the display screen is a row of eight unlabeled pressure-sensitive keys which

correspond to the menu labels. Pressing one of these keys (on the membrane

keypad) initiates the action specified by the corresponding menu label.

This manual indicates that one of these “soft keys” is to be pressed by showing the

label in all caps, bold, sans serif font, and enclosed in brackets. For example, when

the manual calls for the operator to press the key under the RUN label and then the

key under the SPECIMEN TYPE label, the text will read “Press [RUN] followed by

[SPECIMEN TYPE].”

Keyboard/Keypad Keys

In some cases, the operator must press a key on the PC keyboard or on the pressure-

sensitive keypad on the front of the instrument. Such keys include the Enter key,

the ESC key, the pound (#) key, and other special function keys. Special function

keys, such as the arrow keys, are in regular type. The arrow symbol may be

substituted for the word. For example, the text will read “Press the arrow keys” or

“Press the ↑ key” or “Press the ↑ arrow key.”

The Print Screen key on the keyboard can be used to print the screen as it is

displayed on the monitor. This allows the operator an option to print the screen

when the [PRINT] soft key is not available.

Information Presentation Examples

Menu name Sans serif font, all capital letters MAIN MENU

DATA LOG menu

Soft keys (screen label keys) Sans serif font, all capital letters,

enclosed in brackets

[RUN]

Keyboard/keypad keys Regular font, initial capital letters only

when appropriate

arrow keys

↑ arrow key

Enter key

ESC key

Page Up key

the pound (#) key

the asterisk (*) key

Status Regular font, all capital letters READY

STANDBY

INITIALIZED

Data entry field Regular font, enclosed in angle brackets <Operator ID> field

Screen message or other screen

display

Courier Waste Full

ON and OFF All caps, regular font ON

OFF

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NOTE: Press the Print Screen Key only when the displayed screen is at a

static state. Pressing the key during an instrument action, i.e., run

cycle may not print the screen properly.

Safety

Operation, maintenance and servicing of hematology systems may expose

individuals to potential safety and health hazards. All work must be

performed as described in the CELL-DYN Operator’s manual or as

directed by an Abbott Representative. For detailed safety information,

refer to Section 8: Hazards.

Warnings are inserted throughout this manual to alert personnel to

potential hazards. The standard warning conventions including signal

words and symbols are described in Section 8: Hazards.

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Revision Status

Document Control

Number(s)

Revision

Date

Section(s)

Revised

Pages Revised

and Added

9140181H 10/01 All All

9340541B N/A All (new tabset) N/A

9140181J 3/02 Forward All

How To Use This

Manual

All

Master Table of

Contents

pp. 1 through 5; 12 through 14; 19

List of Figures p. 3

1: Use or Function pp. 1-1 and 1-2; 1-8; 1-18 and 1-19

2: Installation

Procedures and

Special

Requirements

pp. 2-3; 2-7; 2-15

3: Principles of

Operation

p. 3-7

4: Performance

Characteristics and

Specifications

pp. 4-4 and 4-5

5: Operating

Instructions

pp. 5-8; 5-10; 5-99

6: Calibration pp. 6-21; 6-26; 6-30 through 6-32; 6-57

7: Operational

Precautions and

Limitations

pp. 7-1 and 7-2

8: Hazards All

9: Service and

Maintenance

pp. 9-12; 9-55 and 9-56

13: Sample Loader p. 13-1

Appendix B pp. B-1; B-3

Index All

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9140181K—July 2002

NOTE: For existing customers, pages of 9140181J will be changed to Revision K and sent with 9140181K

9140181K 7/02 Forward All

How To Use This

Manual

All

Master Table of

Contents

pp. 1 through 5; 10; 12 through 20

List of Figures pp. 3 and 4

List of Tables All

1: Use or Function pp. 1-1 and 1-2; 1-8; 1-16; 1-18 and 1-19

2: Installation

Procedures and

Special

Requirements

pp. 2-3; 2-5; 2-7; 2-15

3: Principles of

Operation

pp. 3-7; 3-16; 3-28; 3-31 through 3-36

4: Performance

Characteristics and

Specifications

pp. 4-4 and 4-5

5: Operating

Instructions

pp. 5-8; 5-10; 5-42 through 5-44; 5-86 and

5-87; 5-99; 5-128

6: Calibration pp. 6-21; 6-26; 6-30 through 6-32; 6-57

7: Operational

Precautions and

Limitations

pp. 7-1 and 7-2

8: Hazards All

9: Service and

Maintenance

pp. 9-12; 9-21; 9-25; 9-46; 9-55 and 9-56;

9-59; 9-61

10:

Troubleshooting

and Diagnostics

pp. 10-24 and 10-25; 10-28 and

10-29; 10-65; 10-89

11: Quality Control p. 11-17

13: Sample Loader p. 13-1

14: Reticulocyte

Package

pp. 14-20; 14-47; 14-61; 14-68 through

14-69

Appendix B pp. B-1; B-3

Index All

Document Control

Number(s)

Revision

Date

Section(s)

Revised

Pages Revised

and Added

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Revision Log

Instructions: Use this log to provide a permanent record to verify

that revised chapter(s) and/or page(s) have been added to this

manual.

1. Record the document control number of the revised section in the first

column. You will find the number in the footer. Make an entry for each

chapter you receive and place in the manual.

2. Record the revision date, also found in the footer, in the second column.

3. Record the current CELL-DYN 3200 System software version in the third

column.

4. Write your initials or signature in the fourth column to verify that you have

placed the revised page(s) in the manual.

5. Record the date that you added the revised section to the manual in the fifth

column.

Conclusion

We hope you have found this preview of the manual useful. The information in this

section should help you better understand the construction and organization of this

manual and help you get started easily and quickly.

Document

Control Number

Revision

Date

Software Version

Revision

Incorporated by

Date

Incorporated

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Abbott CELL-DYN 3200 System Operator's Manual

Abbott CELL-DYN 3200 System Operator's Manual

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