COULTER HmX Hematology Analyzer Manual de usuario

PN 4237523A (July 1999)

COULTER CORPORATION

A Beckman Coulter Company

Miami, Florida 33196-2500 USA

COULTER®HmX Hematology Analyzer

COULTER®HmX Hematology Analyzer with

Autoloader Reference

AVOID EXPOSURE, LASER RADIATION

EMITTED FROM THIS APERTURE

ECKMAN

OULTER

HmX

COULTER

HmX

ECKMAN

OULTER

HmX

COULTER

HmX

READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL

BEFORE ATTEMPTING TO OPERATE INSTRUMENT.

HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING - Might cause injury.

CAUTION - Might cause damage to the instrument.

IMPORTANT - Might cause misleading results.

CAUTION System integrity might be compromised and operational failures might occur if:

r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product

Manuals.

r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s

computer with software authorized by Beckman Coulter.

r You install software that is not an original copyrighted version. Only use software that is an original copyrighted

version to prevent virus contamination.

Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier

protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable laboratory attire when

operating or maintaining this or any other automated laboratory analyzer.

WARNING Risk of operator injury if all covers are not secured in place prior to instrument operation or you attempt to

replace a part without carefully reading the replacement instructions. Do not attempt to replace any component until you

carefully read the instructions for replacing the component.

IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter

distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot

guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most

current information bulletins concerning the product. If you purchased this product from a third party and would like

further information concerning this topic, call your Beckman Coulter Representative.

LEGAL NOTICES

iii

PN 4237523A

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.

REVISION STATUS

Initial Issue, A 7/99

Software version 1.0.

PN 4237523A

REVISION STATUS

PN 4237523A v

CONTENTS

LEGAL NOTICES

REVISION STATUS, iii

CONTENTS, v

INTRODUCTION, xv

HOW TO USE YOUR COULTER® HmX HEMATOLOGY ANALYZER AND HmX

HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET, xv

ABOUT THIS MANUAL, xv

CONVENTIONS, xvi

LIST OF ICONS, xvii

COMPUTER PROGRAM STATEMENT, xvii

1 USE AND FUNCTION , 1-1

1.1 INTENDED USE, 1-1

General, 1-1

Parameters, 1-2

CLIA Complexity Categories, 1-3

1.2 QUALITY CONTROL (QC), 1-3

1.3 METHOD HISTORY, 1-4

Development, 1-4

Hemoglobinometry, 1-4

Differential Measurement, 1-5

Volume Analysis, 1-5

Conductivity Analysis, 1-5

Light Scatter Analysis, 1-5

Reticulocyte (Retic) Analysis, 1-5

%Analysis, 1-5

1.4 SYSTEM COMPONENTS, 1-6

Main Unit, 1-6

Sample Handler, 1-6

Diluter, 1-6

Analyzer/Systems Control Module, 1-6

Electronic Power Supply, 1-6

Pneumatic Power Supply, 1-6

Data Management System (DMS), 1-7

1.5 OPTIONS, 1-7

Printers, 1-7

PN 4237523A

CONTENTS

1.6 REAGENTS, 1-7

Diluent, 1-7

CBC Lytic Reagent, 1-8

HmX PAK, 1-8

PAK LYSE, 1-8

PAK PRESERVE, 1-8

ReticPrep™ Reagent Kit, 1-8

Reagent A, 1-8

Reagent B, 1-8

Cleaning Agent, 1-8

1.7 CONTROLS AND CALIBRATOR, 1-9

Controls, 1-9

Calibrator, 1-9

1.8 MATERIAL SAFETY DATA SHEETS (MSDS), 1-9

2 INSTALLATION, 2-1

2.1 GENERAL, 2-1

2.2 SPECIAL REQUIREMENTS, 2-1

Space and Accessibility, 2-1

Electrical Input, 2-1

Ambient Temperature and Humidity, 2-2

Ventilation, 2-2

Air Conditioning, 2-2

Drainage, 2-2

Date Format, 2-3

2.3 INTERUNIT CONNECTIONS, 2-3

Reagent and Waste Connections, 2-3

Power and Signal Cables, 2-5

3 OPERATION PRINCIPLES, 3-1

3.1 GENERAL PRINCIPLES, 3-1

CBC Analysis, 3-1

Differential Analysis, 3-1

Effect of Reagents, 3-2

Retic Analysis, 3-2

3.2 SPECIMEN TRANSPORT - HmX HEMATOLOGY ANALYZER WITH

AUTOLOADER, 3-3

3.3 SPECIMEN TRANSPORT - HmX HEMATOLOGY ANALYZER, 3-4

3.4 SAMPLE FLOW, 3-5

Normal Sample Flow, 3-5

Retic Sample Flow, 3-9

PN 4237523A vii

CONTENTS

3.5 COUNTING AND SIZING, 3-10

Red and White Blood Cell Counting, 3-10

Routine Counting, 3-10

Extended Counting, 3-10

Coincidence Correction, 3-10

Triplicate Counting/Voting, 3-10

Sweep Flow, 3-11

Pulse Editing, 3-11

RBC Count and Size Distribution, 3-11

Plt Count and Size Distribution, 3-11

Plt Fitting Process, 3-12

Scatterplot Development, 3-12

Differential-Related, 3-12

Retic-Related, 3-13

Retic Parameters, 3-14

Derived and Computed Parameters, 3-14

3.6 Hgb CONCENTRATION MEASUREMENT, 3-14

3.7 PARAMETERS AND THEIR DERIVATION, 3-14

White Blood Cell (WBC) Count, 3-15

Red Blood Cell (RBC), 3-15

Hemoglobin (Hgb) Concentration, 3-15

Mean Corpuscular Volume (MCV), 3-15

Hematocrit (Hct), 3-15

Mean Corpuscular Hemoglobin (MCH), 3-15

Mean Corpuscular Hemoglobin Concentration (MCHC), 3-16

Red Distribution Width (RDW), 3-16

Platelet (Plt) Count, 3-16

Mean Platelet Volume (MPV), 3-16

Differential Counts, 3-16

Percentages, 3-16

Absolute Numbers, 3-17

Reticulocyte (Retic) Parameters, 3-17

Reticulocyte Percent (RET%), 3-17

Reticulocyte Absolute Number (RET#), 3-17

PN 4237523A

viii

CONTENTS

4 SPECIFICATIONS/CHARACTERISTICS, 4-1

4.1 INSTRUMENT SPECIFICATIONS, 4-1

Dimensions, 4-1

Power, 4-1

Installation Category, 4-1

Input - Dedicated Line, 4-1

Consumption, 4-1

Pneumatic Supplies, 4-1

Pressure, 4-1

Vacuum, 4-2

Temperature (Ambient Operating Range for Patient Samples), 4-2

Humidity, 4-2

Recommended Reagents, 4-2

Reagent Usage, 4-2

Recommended Commercial Controls, 4-2

Recommended Calibrator, 4-2

Recommended Anticoagulant, 4-3

Minimum Sample Volume Required, 4-3

Tube Sizes for Closed-Vial Mode, 4-3

Recommended Bar-Code Labels, 4-3

DMS Storage, 4-3

Patient Results, 4-3

Controls, 4-3

Conditions of Measurement, 4-3

Hemoglobin Measurement, 4-3

Aperture Size, 4-4

Electronic Stability, 4-4

Throughput, 4-4

4.2 SOFTWARE SPECIFICATONS, 4-4

Date Format, 4-4

4.3 CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS, 4-4

Precision, 4-4

Accuracy, 4-5

CBC, 4-5

WBC Differential, 4-5

Linearity, 4-5

Mode-to-Mode Matching, 4-6

Background Counts, 4-6

Carryover, 4-7

4.4 RETICULOCYTE PERFORMANCE SPECIFICATIONS, 4-7

Precision, 4-7

Accuracy, 4-7

Reportable Range, 4-8

Operating Range, 4-8

Flagging, 4-8

Limitations, 4-8

PN 4237523A ix

CONTENTS

4.5 PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER , 4-8

Precision of the CBC Parameters, 4-8

Imprecision Analysis by Paired Sample of the Differential Parameters, 4-10

Accuracy of CBC Parameters, 4-10

Accuracy of Differential Parameters, 4-11

Clinical Sensitivity, 4-11

4.6 PERFORMANCE CHARACTERISTICS - HmX HEMATOLOGY ANALYZER WITH

AUTOLOADER, 4-13

Precision of the CBC Parameters, 4-13

Precision of the Differential Parameters - HmX Hematology Analyzer with

Autoloader, 4-13

Accuracy of CBC Parameters - HmX Hematology Analyzer with Autoloader, 4-14

4.7 RETICULOCYTE PERFORMANCE CHARACTERISTICS, 4-15

Imprecision Analysis by Replication, 4-15

Accuracy, 4-15

Reference Interval, 4-16

4.8 INTERFERING SUBSTANCES, 4-16

WBC, 4-16

RBC, 4-16

Hgb, 4-16

MCV, 4-16

RDW, 4-16

Plt, 4-17

MPV, 4-17

Hct, 4-17

MCH, 4-17

MCHC, 4-17

Diff Parameters, 4-17

Reticulocytes, 4-17

5 LASER SAFETY, 5-1

5.1 LASER SAFETY PRECAUTIONS, 5-1

5.2 GENERAL LASER SAFETY WARNINGS, 5-1

5.3 WARNING LABELS, 5-1

6 REPORTING OPTIONS, 6-1

6.1 TICKET FORMAT ON A GRAPHIC PRINTER, 6-1

6.2 GRAPHIC FORMAT, 6-2

PN 4237523A

CONTENTS

7 BAR-CODE SPECIFICATIONS, 7-1

7.1 BAR-CODE LABELS, 7-1

Optical Characteristics at 670 nm ±10%, 7-2

Label Specifications, 7-3

Code-Related Specifications, 7-4

Printing Methods, 7-4

7.2 BAR-CODE READER, 7-4

Description, 7-4

Settings and Defaults, 7-4

7.3 BAR-CODE DECODER, 7-5

Normal Operation, 7-5

HmX Hematology Analyzer, 7-5

HmX Hematology Analyzer with Autoloader, 7-5

A SAMPLE TUBE SIZES, A-1

A.1 BECKMAN COULTER, A-1

A.2 BECTON DICKINSON, A-1

Worldwide, A-1

U.S.A., A-1

Europe, A-2

U.K. and Australia, A-2

Japan, A-2

A.3 GREINER, A-2

Vacuette Brand, A-2

A.4 JOHNS, A-3

A.5 LABCO, A-3

Exetainer Brand, A-3

A.6 LABO EXPRESS SERVICE (L.E.S.), A-3

A.7 LDM, A-3

A.8 L.I.P., A-3

A.9 SARSTEDT, A-3

A.10 SHERWOOD MEDICAL, A-4

A.11 TERUMO (Worldwide), A-4

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