COULTER HmX Hematology Analyzer User manual

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
B ECKMAN
C
OULTER
HmX
COULTER
HmX
®
B ECKMAN
C 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
iv
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

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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

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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
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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

PN 4237523A xi
CONTENTS
B DIFF COMPARISON, B-1
B.1 INTRODUCTION, B-1
B.2 PROCEDURE, B-1
B.3 LOG SHEETS, B-5
LIMITED WARRANTY
REFERENCES, REFERENCES-1
GLOSSARY, GLOSSARY-1
INDEX, 9
TRADEMARKS

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xii
CONTENTS
ILLUSTRATIONS
1.1 The HmX Hematology Analyzer, 1-1
1.2 The HmX Hematology Analyzer with Autoloader, 1-2
1.3 System Version Display, 1-7
2.1 Reagent and Waste Container Tubing Connections, 2-4
2.2 Interunit Connections, 2-5
3.1 Coulter Method of Counting and Sizing, 3-1
3.2 Flow Cell, 3-2
3.3 Loading a Cassette, 3-3
3.4 Reading a Bar-Code Label, 3-4
3.5 BSV, 3-5
3.6 Baths Draining, 3-6
3.7 Sample Flow, 3-7
3.8 Erythrolyse II (PAK LYSE) and StabiLyse (PAK PRESERVE) Reagent Pumps, 3-8
3.9 Aperture Baths and Vacuum Isolators, 3-8
3.10 Sample Movement to the Flow Cell, 3-9
3.11 Sweep Flow, 3-11
3.12 Scatterplot, DF 1 View, 3-12
3.13 Scatterplot, DF 2 View, 3-13
3.14 Scatterplot, DF 3 View, 3-13
3.15 Scatterplot, DF 5 View, 3-14
3.16 Scatterplot, DF 6 View, 3-14
5.1 Laser Safety Label, 5-2
5.2 Safety Labels on the TTM, 5-3
5.3 Laser Safety Labels for Bar-Code Reader on the HmX Hematology Analyzer, 5-4
5.4 Laser Safety Labels for Bar-Code Reader on the HmX Hematology Analyzer with
Autoloader, 5-4
6.1 Ticket Format, 6-1
6.2 Graphic (Wide/Large Page) Format, 6-2
6.3 Graphic (Narrow/Small Page) Format, 6-3
7.1 Bar-Code Label Specifications, 7-3

PN 4237523A
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CONTENTS
TABLES
1.1 CLIA Complexity Table, 1-3
4.1 Precision Specifications, 4-4
4.2 Precision, WBC Differential Parameters, 4-5
4.3 CBC Accuracy Limits, 4-5
4.4 Linearity Limits, 4-6
4.5 Mode-to-Mode Matching, 4-6
4.6 Background Counts for CBC Analysis, 4-6
4.7 Reportable Range, 4-8
4.8 Imprecision Analysis by Replication WHOLE BLOOD - HmX Hematology Analyzer, 4-9
4.9 Imprecision Analysis by Paired Sample - HmX Hematology Analyzer, 4-9
4.10 Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer, 4-10
4.11 Imprecision Analysis (Diff Parameters) by Replication - HmX Hematology Analyzer, 4-10
4.12 Reference Range (Diff Parameters) for 160 Subjects - HmX Hematology Analyzer, 4-10
4.13 Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer, 4-11
4.14 Accuracy Analysis (Diff Parameters) by Compared Specimens - HmX Hematology
Analyzer, 4-11
4.15 Flagging Criteria - H2O Method, 4-12
4.16 Morphologic Abnormalities - HmX Hematology Analyzer, 4-12
4.17 Clinical Sensitivity for Morphologic Abnormals - HmX Hematology Analyzer, 4-12
4.18 Imprecision Analysis by Replication: WHOLE BLOOD - HmX Hematology Analyzer with
Autoloader, 4-13
4.19 Imprecision Analysis by Paired Sample - HmX Hematology Analyzer with Autoloader, 4-13
4.20 Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer with
Autoloader, 4-14
4.21 Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer with
Autoloader, 4-14
4.22 Imprecision Analysis by Replication, 4-15
4.23 Imprecision Analysis by Paired Samples, 4-15
4.24 Accuracy Analysis by Compared Specimens, 4-15
4.25 Reference Intervals, 4-16
7.1 Code 128 Characters, 7-1
7.2 Code-Related Specifications, 7-4
7.3 Bar-Code Reader Settings and Defaults , 7-4

PN 4237523A
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CONTENTS

PN 4237523A xv
INTRODUCTION
This introductory section contains the following topics:
r How to use your COULTER HmX Hematology Analyzer and HmX Hematology Analyzer
with Autoloader Documentation set
r About this Manual
r Conventions
r List of Icons.
HOW TO USE YOUR COULTER®HmX HEMATOLOGY ANALYZER AND HmX
HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET
Use the
Reference
manual for in-depth information about what the instrument does, the
methods it uses, its specifications, and information on installation, safety, and software options.
Use the Special Procedures and Troubleshooting Manual to run a calibration, perform
reproducibility and carryover checks, and to clean, replace, or adjust a component of the
instrument. The troubleshooting tables appear at the back of the manual.
Use the Operator's Guide for the day-to-day running of your instrument. Read the System
Overview chapter to become familiar with the different parts of your system. Then go through
the detailed step-by-step procedures of start up, running controls and samples, reviewing data,
and shutdown.
Use the Host Specifications Manual to locate information about transmission to a host
computer.
Use the Master Index to locate a subject in your documentation set.
See the Documentation page on the back cover of this manual for the contents of each manual.
It can help you to determine quickly which manual contains the information you need.
ABOUT THIS MANUAL
Your COULTER HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader
Reference manual provides in-depth information about what the instrument does, the
methods it uses, its specifications, and information on installation, safety, and software
options.
This manual covers the total HmX system. Use this manual for reference if you have a HmX
Hematology Analyzer or a HmX Hematology Analyzer with Autoloader.
This information is organized as follows:
s Chapter 1, Use and Function
Contains the intended use of the instrument, a brief history of the methods used by the
instrument, the reagents, calibrator, and controls used, and a short description of the
major components and options.
s Chapter 2, Installation
Contains the instrument requirements, the diagrams of the reagent tubing connections,
and the interunit cable connections.

PN 4237523A
xvi
INTRODUCTION
CONVENTIONS
s Chapter 3, Operation Principles
Contains the descriptions of the Coulter Method, the normal sample flow through the
instrument, how counting and sizing are accomplished, and how the parameters are
derived.
s Chapter 4, Specifications/Characteristics
Details the instrument and performance specifications, the performance characteristics,
and the interfering substances.
s Chapter 5, Laser Safety
Describes laser safety precautions and the location of the laser-related labels.
s Chapter 6, Reporting Options
Shows examples of printouts you can select from your graphic printer.
s Chapter 7, Bar-Code Specification
Describes the specifications for bar-code labels to be used with the system.
s Appendices
The appendices provide reference material on the following topics:
r Tu b e S i z e s
r Diff Comparison.
s References
Lists the references, by number, as used throughout this manual.
s Glossary
Contains the definitions for words and terms used in the set of manuals.
s Index
Contains terms and where you can easily locate information about them in this manual.
CONVENTIONS
This manual uses the following conventions:
r ITALICS indicate screen messages such as RESET THE SYSTEM or Press any key.
r Bold indicates
t a menu item such as Run Samples
t or a function such as F3 Run.
r The software path to access the needed function or screen appears in a series separated
by double arrow heads. For example, the path to the REAGENTS set up screen is:
Special Functions tt Set Up tt System Set Up tt Reagents.
To select a menu item, highlight it then press Ûor press the alphabetic key on the
keyboard that corresponds to the letter displayed in black within the name of the menu
item.
r ëindicates a key (such as Û).
r ëëindicates to press and release the first key listed, then press and release the next
key listed.
r ë+ëindicates to press and hold the first key listed, then press the next key.

PN 4237523A xvii
INTRODUCTION
LIST OF ICONS
LIST OF ICONS
COMPUTER PROGRAM STATEMENT
Read this section if you
have a HmX Hematology
Analyzer with
Autoloader.
Read this section if you
have a HmX
Hematology Analyzer.
About the HmX Hematology Analyzer Computer Program
HmX Hematology Analyzer Computer Program, Version 1.0
Copyright©1999 Beckman Coulter, Inc.
All Rights Reserved.
This Computer program is protected by international copyright laws, and unauthorized
copying, use, distribution, transfer or sale is a violation of those laws that may result in civil
or criminal penalties. This computer program may also be subject to additional restrictions
contained in a license granted by Beckman Coulter, Inc. to the authorized user of this
computer program or to the authorized owner or other authorized user of the system onto
which this computer program is installed. Any violation of the license provisions may result
in additional civil penalties, including an injunction and damages. Please refer to the
computer program or system agreement or to the computer program or system
documentation for the terms and conditions of that license.

PN 4237523A
xviii
INTRODUCTION
COMPUTER PROGRAM STATEMENT

PN 4237523A 1-1
1
1USE AND FUNCTION
1.1 INTENDED USE
General
The COULTER HmX Hematology Analyzer, Figure 1.1, and the HmX Hematology Analyzer
with Autoloader, Figure 1.2, are quantitative, automated hematology analyzers and leukocyte
differential cell counters For In Vitro Diagnostic Use in clinical laboratories.
The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all
normal system-generated parameters, from the patient who needs additional studies. These
studies include further measurements of cell size and cell distribution, biochemical
investigation or any other test that helps diagnose the abnormality.
Figure 1.1 The HmX Hematology Analyzer
Main Unit
Graphic Printer
Computer LCD Display
MICTREEBLEBASS
ON/OFF
VOLUME
MAX MIN MAX MIN MAXMIN ON OFF
+
-
EXIT MENU
ON
OFF
AVOID EXPOSURE, LASER RADIATION
EMITTED FROM THIS APERTURE
B ECKMAN
C OULTER
HmX
COULTER
HmX
®

PN 4237523A
1-2
USE AND FUNCTION
INTENDED USE
Figure 1.2 The HmX Hematology Analyzer with Autoloader
Parameters
The systems measure these hematologic parameters of whole-blood specimens:
Main Unit
Graphic Printer
Computer LCD Display
MICTREEBLEBASS
ON/OFF
VOLUME
MAX MIN MAX MIN MAXMIN ON OFF
+
-
EXIT MENU
ON
OFF
B ECKMAN
C OULTER
HmX
COULTER
HmX
®
WBC White Blood Cell (leukocyte) Count
NE% Neutrophil percent
NE# Neutrophil number
LY% Lymphocyte percent
LY# Lymphocyte number
MO% Monocyte percent
MO# Monocyte number
EO% Eosinophil percent
EO# Eosinophil number
BA% Basophil percent
BA# Basophil number
RBC Red Blood Cell (erythrocyte) count
Hgb Hemoglobin concentration
Hct Hematocrit
MCV Mean Corpuscular Volume
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration
RDW Red Cell Distribution Width
Plt Platelet count
MPV Mean Platelet Volume
*PDW Platelet Distribution Width
*Pct Plateletcrit