Beckman Coulter COULTER HmX Operator Training Manual

COULTER HmX Hematology Analyzer
COULTER HmX Hematology Analyzer with

Autoloader

Operator’s Training

Guide

B

ECKMAN

OULTER

C

ECKMAN

B

C

OULTER

AVOID EXPOSURE, LASER RADIATION

EMITTED FROM THIS APERTURE

HmX

COULTER

®

HmX

HmX

COULTER

®

HmX

PN 4237530BB (March 2011)

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

WARNINGS AND PRECAUTIONS

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.

HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING - Can cause injury.

CAUTION - Can cause damage to the instrument.

IMPORTANT - Can cause misleading results.

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:

r All doors, covers and panels are not closed and secured in place prior to and during instrument operation.
r The integrity of safety interlocks and sensors is compromised.
r Instrument alarms and error messages are not acknowledged and acted upon.
r You contact moving parts.
r You mishandle broken parts.
r Doors, covers and panels are not opened, closed, removed and/or replaced with care.
r Improper tools are used for troubleshooting.

To avoid injury:

r Keep doors, covers and panels closed and secured in place while the instrument is in use.
r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors.
r Acknowledge and act upon instrument alarms and error messages.
r Keep away from moving parts.
r Report any broken parts to your Beckman Coulter Representative.
r Open/remove and close/replace doors, covers and panels with care.
r Use the proper tools when troubleshooting.

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.

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.

REVISION STATUS

Initial Issue, A 6/99

Software version 1.0

Revision B, 3/01

Software version 1.3
Information concerning the IVD parameters, MRV and IRF, was added to this training
guide.

®

Changed pages: Cover, iii, ix, 3-5, 3-6, 3-7, 4-10, 4-14, 4-22, 6-26, 7-39, Running 5C
Control summary page 2 of 2, and Control File Management summary page 3 of 3.

Note: Changes that are part of the most recent revision are indicated in text by a bar in the
margin of the amended page.

Revision BA, 5/10

Software Version 1.3.

Updates were made to the company corporate address.

Cell

Note: Changes that are part of the most recent revision are indicated in text by a bar in the
margin of the amended page.

Revision BB, 03/11

Software Version 1.3.

Changes were made to pages, 6-3, 6-22.

Note: Changes that are part of the most recent revision are indicated in text by a bar in the
margin of the amended page.

PN 4237530BB

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 to the Beckman Coulter website. For
labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for
your instrument.

iii

REVISION STATUS

iv

PN 4237530BB

LEGAL NOTICES

REVISION STATUS, iii

CONTENTS, v

INTRODUCTION, vii

1 GETTING TO KNOW YOUR INSTRUMENT, 1-1

2 STARTUP / SHUTDOWN, 2-1

3 SET UP OPTIONS, 3-1

4 QUALITY CONTROL, 4-1

5 CALIBRATION, 5-1

6 SAMPLE ANALYSIS, 6-1

7 DATA REVIEW, 7-1

CONTENTS

8 BASIC TROUBLESHOOTING, 8-1

SUMMARY PAGES

TRAINING CHECKLIST

TRADEMARKS

PN 4237530BB

v

CONTENTS

vi

PN 4237530BB

PURPOSE OF THIS DOCUMENT

To provide an authorized trainer with corporately accepted training materials for instructing a
new operator in the proper use and operation of a COULTER HmX Hematology Analyzer
with Autoloader or a HmX Hematology Analyzer.

DOCUMENTATION

Several manuals and related documents are shipped with a new instrument. It is important
that you familiarize yourself with these materials as soon as possible. Since these materials
may be used during your training, please make sure the following manuals and related
documents are readily available before the training session begins.

HmX Hematology Analyzer with Autoloader

r Reference Manual, PN 4237523, provides in-depth information about what the

instrument does, the methods it uses, its specifications, and information on installation,
safety, and software options.

r Operator’s Guide, PN 4237521, provides step-by-step instructions for the day-to-day

running of your instrument.

r Special Procedures and Troubleshooting Manual, PN 4237522, provides in-depth

information about how to run a calibration, how to clean, replace, or adjust a component
of the instrument, and provides troubleshooting tables as diagnostic tools.

r Host Specifications, PN 4237518, defines the contents of records transmitted from a

HmX Hematology Analyzer with Autoloader to a host computer.

r Master Index, PN 4237525, is a combined index for the Operator’s Guide, Reference,

and Special Procedures and Troubleshooting manuals. Each manual also has an
individual index.

INTRODUCTION

HmX Hematology Analyzer

r Reference Manual, PN 4237523, provides in-depth information about what the

instrument does, the methods it uses, its specifications, and information on installation,
safety, and software options.

r Operator’s Guide, PN 4237519, provides step-by-step instructions for the day-to-day

running of your instrument.

r Special Procedures and Troubleshooting Manual, PN 4237520, provides in-depth

information about how to run a calibration, how to clean, replace, or adjust a component
of the instrument, and provides troubleshooting tables as diagnostic tools.

r Host Specifications, PN 4237518, defines the contents of records transmitted from a

HmX Hematology Analyzer to a host computer.

r Master Index, PN 4237524, is a combined index for the Operator’s Guide, Reference,

and Special Procedures and Troubleshooting manuals. Each manual also has an
individual index.

PN 4237530BB

vii

INTRODUCTION

ABOUT THIS TRAINING GUIDE

ABOUT THIS TRAINING GUIDE

Scope

This training guide provides the trainer with the opportunity to customize the training
experience to best fit the individual trainee and laboratory. Since trainee experience levels and
laboratory needs differ, this training outline is designed with flexibility in mind.

This document is designed to support both HmX Hematology Analyzer with Autoloader and
HmX Hematology Analyzer training. Material that is unique to the autoloader or the
single-specimen, rotary cap-pierce analyzer is clearly identified, usually with the analyzer’s
name at the top of the page.

r HmX Hematology Analyzer with Autoloader headers indicate the autoloader version of

the analyzer.

r HmX Hematology Analyzer headers indicate the single-specimen, rotary cap-pierce

version of the analyzer.

r Using the term instrument or HmX instrument indicates the material applies to both.

Topics

The materials in this guide support the training of eight different topics:

r Topic 1 GETTING TO KNOW YOUR INSTRUMENT

r Topic 2 STARTUP / SHUTDOWN

r Top ic 3 SE T U P O PT I ON S

r Topic 4 QUALITY CONTROL

r Top ic 5 CA LI BR AT IO N

r Topic 6 SAMPLE ANALYSIS

r Top ic 7 DATA RE VI EW

r Topic 8 BASIC TROUBLESHOOTING

Each topic consists of several related subjects that may be used, as needed, in your training.

Organization

The eight individual topics contained in the Operator’s Training Guide are part of a larger
organization that includes four basic types of information:

Introduction Explains how to use this training guide

Topics Heart of this document, each topic consists of multiple subjects and

operational summaries relating to the overall topic

viii

Summary Pages Master copy for use by the Key Operator in their laboratory once

training is complete

Training Checklist Method for documenting the specific training an operator receives

PN 4237530BB

INTRODUCTION

RESPONSIBILITIES

Summary Pages

Routine operational tasks detailed in the various instrument manuals are abbreviated in this
training document. These abbreviated instructions are referred to as either summary pages or
operational summaries. Each summary page is an individual, stand-alone document that is
designed for use in your laboratory as a training aid and/or as a reference tool for a trained
operator. A master copy of each summary page is located behind the

These summary pages contain essential operational instructions. As a result, it is important
that you become proficient in the use of this tool during your training. To eliminate the need
to flip back and forth between the topic and the summary masters, the appropriate
operational summaries are inserted within each topic. When an operational summary is
inserted in the training material, a rotated chevron (
Page title. For example, at the point of insertion, the Startup summary would begin with

➤) appears to the left of the Summary

Summary Masters tab.

➤ Startup Summary

Since this is a stand-alone summary for use after training is complete, some of the
instructions discussed in the training topic may be repeated in the summary. Two rotated
chevrons (

➤ ➤) mark the end of the inserted summary.

Training Checklist

This checklist provides the trainer with an official method to document the completion of
training on the COULTER HmX Hematology Analyzer with Autoloader or the HmX
Hematology Analyzer.

When the training process is complete, we recommend that both the trainer and trainee sign
the Training Checklist to show agreement that the trainee is sufficiently trained and able to
meet the objectives listed for each topic.

RESPONSIBILITIES

Beckman Coulter’s Responsibility

Beckman Coulter is responsible for instructing a Key Operator in the proper use and
operation of a COULTER HmX Hematology Analyzer with Autoloader or a HmX Hematology
Analyzer.

Our goal is to provide your laboratory with high quality training that best fits your
laboratory’s needs. This means the emphasis given to each topic may differ, with some topics
needing to be covered more thoroughly than others.

Key Operator’s Responsibility

It is the Key Operator’s responsibility to train all other operators in their laboratory. To assist
you in this process, a master copy of each operational summary is located at the end of the
Operator’s Training Guide. Once trained by an authorized Beckman Coulter trainer, the Key
Operator is authorized to copy these masters for use in training other laboratory personnel.

PN 4237530BB

ix

INTRODUCTION

CONVENTIONS

CONVENTIONS

This training guide uses the following conventions:

r Italics font indicates screen text and/or messages displayed by the instrument such as

r Note (in bold font) prefaces information that is important to remember or helpful in

r

RESET THE SYSTEM or Press any key.

performing a procedure.

Bold indicates

t a menu item such as

t or a function such as F3 Run.

r ë indicates a key such as Û.
r Ì indicates the operator needs to press and release the F4 key.
r ë ë indicates to press and release the first key listed, then press and release the next

key listed.

r ë + ë indicates to press and hold the first key listed, then press the next key.

r Software navigation to access a needed function or screen appears as a sequence of menu

items separated by double arrow heads. For example, the path to the screen for setting
up reagents is
contains one letter displayed in black.

r To select a particular menu item,

t Use the æ or ç keys to highlight the menu item then press Û

or

t Note the black letter within the desired menu item and press the corresponding

alphabetic key. (It is not necessary to press the Û key.)

r A rotated chevron (

summary inserted within the training materials. For example,

Special Functions tt Set Up tt System set up tt Reagents. Each menu item

Run Samples

➤) placed to the left of a Summary Page title identifies an operational

➤ Changing Reagents Summary

GRAPHICS

x

r Two rotated chevrons (➤ ➤) designate the end of an operational summary.

r HmX Hematology Analyzer with Autoloader or HmX Analyzer with Autoloader indicates

an autoloader unit.

r HmX Hematology Analyzer or HmX Analyzer indicates a single-specimen, rotary

cap-pierce unit.

r Instrument or HmX instrument indicates information concerning both the autoloader

and the single-specimen, rotary cap-pierce versions of the analyzer.

All graphics, including screens and printouts, are for illustration purposes only and must not
be used for any other purposes.

PN 4237530BB

OBJECTIVES

When the subject is complete, you will be able to . . .

Data Management System (DMS)

r Locate and name the three major components of the peripheral computer system.

r Locate and explain the function of specific keys on the keyboard.

r Quickly access a commonly used area of software using the Access screen.

r Select a desired option from the DMS Main Menu or submenu.

r On the Status line, explain the meaning of the

r Replace the ribbon or ink cartridge and paper in the printer.

Main Unit

r Locate and name the hardware controls and indicators.

r Given an instrument that appears to be without power,

GETTING TO KNOW YOUR INSTRUMENT

1

t Symbols
t Background colors
t Up arrows versus down arrows.

1

t Tell whether it is powered down or in Standby.
t Bring the instrument back into operation.

r Reset the system.

r Locate, name, and explain the major function of each module.

Modes of Operation

r State the four modes of operation available on HmX instruments.

r Briefly overview the Primary mode of operation versus the Secondary mode of operation.

r List four situations when the Secondary mode can be used.

r Demonstrate how to silence an alarm.

Reagents

r Name the reagents used on a HmX instrument.

r State if the reagent is used for CBC analysis, DIFF analysis, or both.

r State if the reagent is used for Retic analysis.

r State the open container stability of each reagent used on a HmX instrument.

r Explain how to change reagents.

r Explain how to replace a waste container, if applicable.

PN 4237530BB

1-1

GETTING TO KNOW YOUR INSTRUMENT

ACCESS SCREEN

ACCESS SCREEN

COULTER(R) HmX HEMATOLOGY ANALYZER

F1

RUN

SAMPLES

F4

DATA BASE

QUERY

This program is protected by U.S. and International laws as described

in the manual. (C) Copyright Beckman Coulter Inc., 1999

02/28/99 10:14 OPR DMS PR HC DB XB WL HWL QC

F5

WORKLIST

F2

RUN

CONTROLS

F6

HOST

WORKLIST

F3

CLEAN

F9
MAIN
MENU

SELECT FUNCTION

r First screen to appear after a system reset or power up

r Screen provides operator with quick access to the most commonly used areas of the

software

1-2

r Display automatically returns to the Access screen upon exit when this screen is used to

access any of the designated software areas

r May also display this screen from the Main Menu by pressing É

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

SOFTWARE MENU TREE - HmX Hematology Analyzer with Autoloader

SOFTWARE MENU TREE - HmX Hematology Analyzer with Autoloader

1

Sample Analysis

Run Samples
Data Base Query
Worklist
Host Worklist
XB

Current XB batch
XB batch means
XB graphs

F3 from Run Samples screen

SAMPLE MODE?

F2
F3
F4
F5
F6
F7
F8
F9

DIFF: ON
BLOOD DET: ON

Select to change/ESC to continue

F5 from Run Samples screen

F2 XB: ON N=2 IN
F4 DB: ON
F5 Print: NONE
F6 Host: OFF
F7 Display only: OFF
F8 Operator: OPR
F11 B&W screen print
F12 Color screen print

Control Run
Review or Report
Graphs

START PRIMARY
SECONDARY
PREDILUTE CBC
RETIC
DIFF ON/OFF
PURGE
RINSE
STOP

Controls

Diluent
Lyse
Pak
Cleaner
All

Diluter Functions

Prime Reagents
Start Up
Shut Down
Disinfect

Reproducibility
Carryover
CBC Calibration
Enter Calibration Factors

Special Functions

Diagnostics
Set Up
Calibration
Error File

Workload recording
Operator options
Service options

Control set up
Sample analysis set up
System set up

Fluidic Tests
BSV Tests
Autoloader tests
System Test
Solenoid Test
Drain and Vent
HGB Lamp Adjust

CBC/DIFF file
Latex file
CBC file
RETIC file
Auto-Stop

Action limits
Location list
Physician list
Display formats
Delete database
Delete host spooler
Clear printer spooler queue
Print options

Shift
Reagents
Institution
Communication def
IQAP ID #
Set Date/Time
Supervisor Password
Optimize Hard Disk

Multiple Aperture Zap
Compressor On/Off
Disable Reagent Sensors
Bubble Mix
Clean Needle

Cycle BSV
Blood Detector Test
Probe Wash
BSV Removal
Blood Detector ON/OFF

Autoloader Home
Clear the Bed/
Autoloader Home
Rock the Bed
Right Elevator Up/Down
Left Elevator Up/Down
Autoloader Test Routine

XB limits
Definitive flag limits
High/low flag limits
Laboratory Normal Ranges

Screen Labels
Parameter Selection
Reporting Units

Auto Print Format
Ticket Options
Spooler Priority
Graphics Options
Optional Printer

Host Computer Definition

PN 4237530BB

1-3

GETTING TO KNOW YOUR INSTRUMENT

SOFTWARE MENU TREE - HmX Hematology Analyzer

SOFTWARE MENU TREE - HmX Hematology Analyzer

Sample Analysis

Run Samples
Data Base Query
Worklist
Host Worklist
XB

Current XB batch
XB batch means
XB graphs

F3 from Run Samples screen

SAMPLE MODE?

F2
F3
F4
F5
F6
F7
F8
F9

DIFF: ON
BLOOD DET: ON

Select to change/ESC to continue

F5 from Run Samples screen

F2 XB: ON N=2 IN
F3 CAP PIERCER 10mm-13mm
F4 DB: ON
F5 Print: NONE
F6 Host: OFF
F7 Display only: OFF
F8 Operator: OPR
F11 B&W screen print
F12 Color screen print

Control Run
Review or Report
Graphs

START PRIMARY
SECONDARY
PREDILUTE CBC
RETIC
DIFF ON/OFF
PURGE
RINSE
STOP

Controls

Diluent
Lyse
Pak
Cleaner
All

Diluter Functions

Prime Reagents
Start Up
Shut Down
Disinfect

Reproducibility
Carryover
CBC Calibration
Enter Calibration Factors

Special Functions

Diagnostics
Set Up
Calibration
Error File

Workload recording
Operator options
Service options

Control set up
Sample analysis set up
System set up

Fluidic Tests
BSV Tests
CVS Functions
System Test
Solenoid Test
Drain and Vent
HGB Lamp Adjust

CBC/DIFF file
Latex file
CBC file
RETIC file
Auto-Stop

Action limits
Location list
Physician list
Display formats
Delete database
Delete host spooler
Clear printer spooler queue
Print options

Shift
Reagents
Institution
Communication def
IQAP ID #
Set Date/Time
Supervisor Password
Optimize Hard Disk

Multiple Aperture Zap
Compressor On/Off
Disable Reagent Sensors
Bubble Mix
Clean Needle

Cycle BSV
Blood Detector Test
Probe Wash
BSV Removal
Blood Detector ON/OFF

CVS Initilize
Cycle CVS

XB limits

Definitive flag limits

High/low flag limits

Laboratory Normal Ranges

Screen Labels
Parameter Selection
Reporting Units

Auto Print Format
Ticket Options
Spooler Priority
Graphics Options
Optional Printer

Host Computer Definition

1-4

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

STATUS LINE TABLE

07/13/99 19:34 OPR DMS PR P2 HC DB XB WL HWL QC

STATUS LINE TABLE

1

Symbol Refers to

DMS Data

Management
System

PR* Graphics

Printer

HC Host

Computer

DB Data Base Store is ON. Store is OFF. Data base is not

XB

WL Worklist Preassigned

HWL Host Worklist Preassigned

QC Quality Control Auto-Stop is

P2 Additional

% Analysis

Graphics
Printer

↑↓

Connected to
Analyzer.

Autoprint is set
to ALL,
ABNORMALS or
NORMALS.

Auto
transmission
ON.

XB is ON. XB is OFF. Last completed

entries pending
on Worklist.

entries are on
the Host
Worklist.

ON.

Autoprint is ON. Autoprint is OFF. Printer is

Not connected
to Analyzer.

Autoprint is set
to NONE.

Auto
transmission
OFF.

No preassigned
entries on the
Worklist.

No preassigned
entries on the
Host Worklist.

Auto-Stop is
OFF.

Red Yellow White

Not
communicating
with Analyzer.

Printer is
off-line OR
Printer is out of
paper.

Not connected
to host.

functional.
System stops.
Reset the
system and
rerun last 2
specimens.

batch was OUT
(outside the XB
Action Limits).

3 consecutive or
10 total error
messages are in
the status field.

Host Worklist is
full.

Last control run
had an error
message.

off-line OR
printer is out of
paper.

DMS busy or
receiving data.

Printer is
printing.

Sending to host
computer.

Data base is
storing data.

N/A Last completed

The Worklist is
full (300
preassigned
samples).

DMS is
receiving
preassigned
samples from
the host
computer.

Receiving a
control run.

Printer is
printing.

DMS is OK.

Printer and DMS
are connected.

Host and DMS
are connected.

Data base is OK.

batch was IN
(within the XB
Action Limits).

Worklist is OK.

Host Worklist is
OK.

Results of last
control run are
OK.

Printer and DMS
are connected.

PN 4237530BB

* Changes to MA for manual printing, BA for batch printing, and AU for autoprinting.

1-5

GETTING TO KNOW YOUR INSTRUMENT

DATA MANAGEMENT SYSTEM (DMS)

DATA MANAGEMENT SYSTEM (DMS)

Functions of the Data Management System (DMS)

r Controls and monitors instrument operation

r Displays, stores, outputs, and allows recall of sample results

r Stores and graphs control results for the QC program

r Automatically calculates new calibration factors

r Allows bidirectional communication with a host computer

r Consists of three major components: the computer, the monitor, and the printer

Major Components

Computer

r Must not use this system as a personal computer

r Consists of hardware components and software

r Hardware is the term used to describe the physical components of a computer system

t Locate the following hardware components:

- Power ON/OFF button

- Power ON/OFF indicator light

- Hard drive indicator and symbol

- Diskette drive

r Software refers to a sequence of detailed instructions (called a program) that directs the

computer to perform certain actions

t Data Management System or DMS refers to the software used in the computer

Monitor

r Computer uses the monitor to visually display information

r Locate the Power ON/OFF switch and the indicator light that lights when power is on

r Locate screen adjustment controls

Printer

r Used to either print a copy of the screen displayed on the monitor or of data stored in the

computer’s data base

r Up to two printers can be used with your system

r Locate the Power ON/OFF switch

1-6

r Explain use of the ONLINE/OFFLINE button

r Demonstrate how to load the paper

r Demonstrate how to change the ribbon or ink cartridge

Keyboard

r Direct line of communication between the operator and the peripheral computer

containing the DMS software program

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

DATA MANAGEMENT SYSTEM (DMS)

Layout

r Alphanumeric keys

t Configured in a standard typewriter keyboard layout
t Consists of all standard alphanumeric keys plus a handful of special computer keys

and symbols

r Ú

t Works like the Shift Lock key on a typewriter
t With

r Numeric keypad

t Keypad contains the numbers 0 through 9, plus the period, an Û key, and various

t Can expedite manual entry of patient ID numbers and certain quality control entries

Caps Lock on,

- Pressing any alphabet key on the keyboard produces an uppercase letter

- Pressing the Ü key plus a letter produces a lowercase letter

- Only shifts the letter keys, all other keys on the keyboard remain the same

mathematical symbols

1

r ê

t Controls operation of the numeric keypad
t Locate light that illuminates when
t With
t DMS keyboard is designed to be used with
t With

r Cursor control keys

t è æ ç é

t ä and å

t â and ã

t à and á keys are not used with the DMS program

Num Lock on, the numeric keypad produces numbers

Num Lock off, the numeric keypad on a typical keyboard doubles as a cursor

keypad; however, the DMS program is designed for use with the cursor control keys

- Also called arrow keys

- Directional keys for moving the cursor on the screen

- Used to highlight menu items, scroll up and down screens, or move to a field on
a screen to enter or edit data

- Commonly used to page through stored sample and control data

- Generally used to locate the beginning or the end of stored data

Num Lock is turned on

Num Lock on

PN 4237530BB

- When appropriate, a function key is designated as a delete key

r É through Ô Function Keys

t Pressing a Function Key activates the function assigned to that key
t For example, if a screen displays

displayed data and exits the screen display at the same time

r Õ key is not used with the DMS program

t When appropriate, a function key is designated as a print key

F10-Save/Esc as an option, pressing Ò saves the

1-7

GETTING TO KNOW YOUR INSTRUMENT

DATA MANAGEMENT SYSTEM (DMS)

r Û

t Mainly used to confirm a menu or submenu selection which then activates a change

in the screen display

t Do not use Û to bring up the DMS display as pressing this key may activate a

command

t Keyboard has two Û keys

- Both work identically

- Û key was placed by the numeric keypad to facilitate rapid entry of numbers

r È

t Used to back out of an option one screen at a time
t Use Ò

Save/Esc instead of È to store data you just entered or edited

r ß

t Used to toggle among options when a choice is required
t Use the ßto bring up the DMS display when the screen is dark

r Ý and Þ

t Modifier keys that have no action by themselves but can be used in conjunction

with other keys to generate special characters or operations not readily available at
the keyboard

Hot Keys

r Also called shortcut keys because they allow the operator to do certain functions quickly

r Includes the following:

É Displays the Access screen

(only available when the Main Menu is displayed)

Ì Prints

Ñ Exits the current screen and returns to either the Main Menu or the

Access screen depending on point of origination

Exception → if the F3 Run window is displayed, then the function of

Ñ is Stop

Ò Saves and/or returns to the previous screen

Þ + ã Stops instrument beeping and removes the error message at the

bottom of the screen

Ý + Ê Moves from the current screen to the Error file and back to the

original screen

Ý + w Moves from Sample Analysis screen to Worklist and back when a

submenu or window is not displayed

1-8

Ý + Ñ Stops the cycle (HmX Hematology Analyzer with Autoloader only)

Ý + C Clears the bed (HmX Hematology Analyzer with Autoloader only)

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

DATA MANAGEMENT SYSTEM (DMS)

Screen Conventions

r DMS uses several conventions that either reduce keystrokes or aid the operator in

obtaining the proper screen needed to complete a desired task

Menu Item Conventions

r Are displayed in blue text

r Each menu item contains one black letter

t Pressing the corresponding alphabetic key is one way of selecting that particular

menu item

t Pressing Û is not necessary

r Main Menu items have designated colors

1

t Sample Analysis

t Controls

t Diluter Functions

t Special Functions

r Designated color coding appears on

t Submenu borders
t Screen titles
t Titles that are part of a bordered display box

Display Screen Conventions

r As a general rule, black text indicates a screen label or a field that cannot be edited;

blue text indicates a field that can be edited

r Numeric data stored in a table generally has a turquoise background

Instructional and Informational Message Convention

r Most, but not all, instructional or informational messages appear as black text with a

black border

blue

green

magenta

orange

PN 4237530BB

To continue HmX Hematology Analyzer training, proceed to page 1-10.

To continue HmX Hematology Analyzer with Autoloader training, go to page 1-18.

1-9

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

MAIN UNIT - HmX Hematology Analyzer

Front View of the Main Unit

POWER On/Off

rocker switch

C

ECKMAN

B

OULTER

READY
indicator
light

COMPUTER AC

POWER

AC INPUT

STANDBY

AVOID EXPOSURE, LASER RADIATION

EMITTED FROM THIS APERTURE

indicator
light

Red LED

Green LED

Standby/Reset

rocker switch

Exit
tray

HmX

Entry

port

®

HmX

COULTER

Bar-code

reader

Aspirator probe

Sample bar

IMPORTANT Risk of misleading results. Electrical interference can produce erratic parameter results. Operate

this instrument with all the doors closed to minimize external electrical interference.

Controls and Indicators

1-10

POWER On/Off Rocker Switch

r Main POWER On/Off switch located on the back of the Main Unit

r Recommend the Main Power be left on at all times

t Prolongs the life of the lasers
t Increases stability of electronic components

Standby/ Reset Rocker Switch

r Located on the left side of the lower front door, near the bottom

r Used to place instrument in a Ready or Standby state

t Symbol for indicating the Ready state is “

|”

t Symbol for indicating the Standby state is “O”

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

r Instrument state is determined by the position of this rocker switch

t In the Ready state, the back portion of the rocker switch is flush with the

instrument’s base; this is position

t In the Standby state, the front portion of the rocker switch is flush with the

instrument’s base; this is position

r Also used to reset the system or reestablish communication between components

|

O

1

t To reset the system, place the Standby/Reset rocker switch in Standby (position

for 15 seconds then flip the switch back to Ready (position

Ready Indicator Light

r Used to quickly identify instrument status

r When the light is ON, the Main Power is ON and the instrument is ready for operation

r When the Standby (

is OFF

Standby Indicator Light

r Used to quickly identify instrument status

r When the light is ON, the Main Power is ON and the instrument is in the Standby state

r To return to the Ready state, the

r Standby/Reset rocker switch must be moved to Ready, position

r In the Standby state, voltages are still being applied to a memory location in the Analyzer

but everything else is powered down

r When the Standby (

is OFF

Entry Port

r Port for inserting closed-vial specimen tubes

O) and Ready (|) indicator lights are OFF (not lighted), Main Power

O) and Ready (|) indicator lights are OFF (not lighted), Main Power

|)

|

O)

PN 4237530BB

Exit Tray

r Output tray for specimen tubes processed using the carousel in the Rotary Cap-Pierce

module in the Closed-Vial mode

Aspirator Probe

r Used to aspirate from an open vial containing a whole-blood specimen, prediluted

specimen, or a retic preparation

r Also used to aspirate from an open bottle of LATRON Primer or Control

Sample Bar

r Press to start aspiration from an open vial

1-11

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

Bar-code Reader

r Scanner for reading the bar-code label on a specimen tube before either closed-vial or

open-vial sampling

Green LED

r When scanning a bar-code label, a glowing green LED indicates the barcode was read

successfully - the operator can process the specimen

Red LED

r Glowing red LED means wait

r When scanning a bar-code label, a glowing red LED indicates the barcode was not read

successfully

MODES OF OPERATION

HmX Hematology Analyzer . . . a Single-Specimen, Rotary Cap-Pierce System

Primary Mode

r The lower door of the Main Unit must remain closed while the instrument is cycling

r Also referred to as the Closed-Vial or Automatic mode

r Carousel rotates the specimen tube from the entry port to the cap-piercing station then

when sampling is complete, carousel rotates again to deposit the tube onto the exit tray
for removal by the operator

r Aspirates 185 µL of sample from each tube

r Specimen tubes must contain at least 1.0 mL of whole blood (minimum volume with the

proper proportion of blood to anticoagulant)

r Tube and tube devices can be used if they fall within the following ranges:

diameter of 10 to 16 mm / length of 47 to 77 mm / capacity of 2 to 7 mL

t Beckman Coulter control and calibration tubes can also be used

t Before inserting a specimen tube through the entry port, it may be necessary to

change the size of the carousel tube slot from the 10mm-13mm tube slot to the
16mm tube slot, or vice versa

t See Appendix A of the Reference Manual for a listing of tested collection devices

r May run specimen tubes with or without bar-code labels

1-12

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

Secondary Mode

r Also referred to as the Open-Vial or Manual mode

r Aspirates 125 µL of sample from each tube via the aspirator probe

r Opening for aspiration is located on the back side of the aspirator probe’s tip

r Mode used for processing

t Microsamples

t Retics

t LATRON Primer and Control

t Any specimen tube that does not fit into the carousel

t Any specimen tube with insufficient sample volume for processing in the Primary

(Closed-Vial) mode of operation (that is, tubes containing <1.0 mL of whole blood)

t Any samples requiring dilution

Predilute Mode

r Aspirator probe also used for running samples in the Predilute mode

r CBC mode only

1

r Requires specimen to be diluted 1:3 (minimum 50 µL of blood and 100 µL of diluent)

r Aspirates 125 µL of the prediluted sample via the aspirator probe

r Final results are calculated automatically

Retic Mode

r Aspirator probe also used for running samples in the Retic mode

r Sample preparation is required before processing

r Aspirates approximately 2 mL of the sample dilution via the aspirator probe

PN 4237530BB

1-13

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

MAIN UNIT - HmX Hematology Analyzer

Modules on the Front of the Main Unit

Analyzer

module

Electronic

ower Supply

CBC module

BSV module

1-14

Rotary

Cap-Pierce

module

Pump module

PN 4237530BB

INSTRUMENT MODULES

Modules on the Front of the Main Unit

Analyzer Module

r Also referred to as the Analyzer/ Systems Control module

r Contains the various circuit boards needed to operate the instrument

r Controls the timing and sequencing of the operating cycles

r Receives pulses and raw data from the CBC and VCS modules

r Counts, measures, and computes CBC parameter results

r Sends final CBC parameter results and VCS data to the DMS

Electronic Power Supply

r Supplies the necessary power for all instrument operations

Rotary Cap-Pierce Module

r Single specimen tube transport and cap-piercing system

r When the specimen tube is inserted through the entry port, the carousel rotates the tube

to the cap-piercing station where the needle pierces the tube’s stopper so that 185 µL of
whole blood can be aspirated from the specimen tube into the instrument for analysis

r When the aspiration is complete, the carousel rotates the specimen tube away from the

needle and deposits it onto the exit tray for removal by the operator

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

1

CBC Module

r Contains all the components necessary for CBC analysis

BSV (Blood Sampling Valve) Module

r Contains components associated with the sampling of blood including the aspiration

pumps for pulling sample from the specimen tube into the instrument

r Also contains the sheath tank that supplies the diluent needed for proper sample flow for

differential analysis using VCS technology

Pump Module

r Contains the two Erythrolyse II reagent pumps needed for differential analysis using

VCS technology

PN 4237530BB

1-15

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

Right Side of the Main Unit

041993

Main Diluter module

Mixing

module

LASER

ON

Flow Cell module

Modules on the Right Side of the Main Unit

Main Diluter Module

r Contains various components relating to sample dilution and cycling as well as vacuum

and pressure regulators

Flow Cell Module

r Contains the components necessary for analyzing the WBC Diff and Retics using VCS

technology

r Also referred to as the Triple Transducer Module (TTM)

r Flow cell and laser are inside a protective housing

Mixing Module

r Associated with the VCS portion of the system

r Used to mix the whole blood sample with the reagents needed to prepare the sample for

WBC differential analysis using VCS technology

1-16

PN 4237530BB

Back View of the Main Unit

Reagent

manifold

and

connectors

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer

Fans

Power ON/OFF
rocker switch

Plugs for
computer

1

Pneumatic Power Supply

Module on the Back of the Main Unit

Pneumatic Power Supply

r Source of the vacuums and pressures used throughout the instrument

r The compressor/ vacuum pump produces one service adjustable level of air pressure,

60 psi and one nonadjustable level of vacuum, >22" Hg

To continue HmX Hematology Analyzer training, go to page 1-26.

PN 4237530BB

1-17

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Front View of the Main Unit

POWER On/Off

rocker switch

POWER

COMPUTER AC

AC INPUT

Emergency

Stop button

Standby/Reset

rocker switch

C

B

ECKMAN

OULTER

HmX

Loading bay

COULTER

READY
indicator
light

STANDBY
indicator
light

Aspirator probe

Sample bar

®

HmX

1-18

IMPORTANT Risk of misleading results. Electrical interference can produce erratic parameter results. Operate

this instrument with all the doors closed to minimize external electrical interference.

Controls and Indicators

POWER On/Off Rocker Switch

r Main POWER On/Off switch located on the back of the Main Unit

r Recommend the Main Power be left on at all times

t Prolongs the life of the lasers

t Increases stability of electronic components

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Standby / Reset Rocker Switch

r Located on the left side of the lower front door, near the bottom

r Used to place instrument in a Ready or Standby state

1

t Symbol for indicating the Ready state is “
t Symbol for indicating the Standby state is “O”

r Instrument state is determined by the position of this rocker switch

t In the Ready state, the back portion of the rocker switch is flush with the

instrument’s base; this is position

t In the Standby state, the front portion of the rocker switch is flush with the

instrument’s base; this is position

r Also used to reset the system or reestablish communication between components

t To reset the system, place the Standby/Reset rocker switch in Standby (position

for 15 seconds then flip the switch back to Ready (position

Ready Indicator Light

r Used to quickly identify instrument status

r When the light is ON, the Main Power is ON and the instrument is ready for operation

r When the Standby (

is OFF

Standby Indicator Light

r Used to quickly identify instrument status

r When the light is ON, the Main Power is ON and the instrument is in the Standby state

r To return to the Ready state, the Standby/Reset rocker switch must be moved to Ready,

position

r In the Standby state, voltages are still being applied to a memory location in the Analyzer

but everything else is powered down

r When the Standby (

is OFF

|

O) and Ready (|) indicator lights are OFF (not lighted), Main Power

O) and Ready (|) indicator lights are OFF (not lighted), Main Power

|

O

|”

O)

|)

PN 4237530BB

Loading Bay

r Cassettes are loaded here for processing in the Primary (Closed-Vial) mode

Aspirator Probe

r Used to aspirate from an open vial containing a whole-blood specimen, prediluted

specimen, or a retic preparation

r Also used to aspirate from an open bottle of LATRON Primer or Control

Sample Bar

r Press to start aspiration from an open vial

Emergency Stop Button

r Press this button to immediately stop the autoloader mechanism

1-19

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

MODES OF OPERATION

HmX Hematology Analyzer with Autoloader

Primary Mode

r The lower door of the Main Unit must remain closed while the instrument is cycling

r Also referred to as the Closed-Vial or Automatic mode

r Autoloader uses the rocker bed and sensors to move specimen tube holders called

cassettes from the loading bay to a cap-piercing station, then to the unloading bay

r Aspirates 185 µL of sample from each tube

r Specimen tubes must contain at least 1.0 mL of whole blood (minimum volume with the

proper proportion of blood to anticoagulant)

r Up to five specimen tubes of various types and sizes can be loaded into a cassette

r Tube and tube devices can be used if they fall within the following ranges:

diameter of 10 to 16 mm / length of 47 to 77 mm / capacity of 2 to 7 mL

t Beckman Coulter control and calibration tubes can also be used

t See Appendix A of the Reference Manual for a listing of tested collection devices

r Proper size cassette must be used

t Use only 10 to 13 mm o.d. tubes in the universal cassette with gray inserts

t Use only 16 mm o.d. tubes in the cassette with black inserts

t When loading tubes into a cassette, make sure each specimen tube fits securely

inside the cassette to prevent blood spills that may occur if a tube falls or a cap is
pierced off center

r May run specimen tubes with or without bar-code labels

r Stop button is for emergency use only

Secondary Mode

r Also referred to as Open-Vial or Manual mode

r Aspirates 125 µL of sample from each specimen tube via the aspirator probe

r Opening for aspiration is located on the back side of the aspirator probe’s tip

r Mode used for processing

t Microsamples

t Retics

t LATRON Primer and Control

t Any specimen tube that does not fit into the cassette

t Any specimen tube with insufficient sample volume for processing in the Primary

(Closed-Vial) mode of operation (that is, tubes containing <1.0 mL of whole blood)

1-20

t Any samples requiring dilution

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Predilute Mode

r Aspirator probe also used for running samples in the Predilute mode

r CBC mode only

r Requires specimen to be diluted 1:3 (minimum 50 µL of blood and 100 µL of diluent)

r Aspirates 125 µL of the prediluted sample via the aspirator probe

r Final results are calculated automatically

Retic Mode

r Aspirator probe also used for running samples in the Retic mode

r Sample preparation is required before processing

1

PN 4237530BB

1-21

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Modules on the Front of the Main Unit

Analyzer

module

Electronic

Power Supply

CBC module

BSV module

DO NOT STARE INTO BEAM

CAUTION

LASER LIGHT

1.0 MILLIWATT MAXIMUM CLASS II LASER PRODUCT
670 nm DIODE LASER

1-22

Autoloader

module

Pump module

PN 4237530BB

INSTRUMENT MODULES

Modules on the Front of the Main Unit

Analyzer Module

r Also referred to as the Analyzer/ Systems Control module

r Contains the various circuit boards needed to operate the instrument

r Controls the timing and sequencing of the operating cycles

r Receives pulses and raw data from both the CBC and VCS modules

r Counts, measures, and computes CBC parameter results

r Sends final CBC parameter results and VCS data to the DMS

Electronic Power Supply

r Supplies the necessary power for all instrument operations

Autoloader Module

r Cassette transport and cap-piercing system

r Contains the robotic mechanisms to move the specimen tube holders called cassettes

from the loading bay to the cap-piercing station and then to the unloading bay

r Up to five specimen tubes can be loaded into a cassette which is then placed in the

loading bay

r Once operation is initiated, the bottom cassette is lowered onto the rocker bed where the

cassette is rocked back and forth while it moves along the bed to the cap-pierce station

r Each time a tube reaches the cap-pierce station, the needle pierces its stopper so that

185 µL of whole blood can be aspirated from the specimen tube into the instrument for
analysis

r When all the specimen tubes are pierced, the rocker bed moves the cassette to the

unloading bay for removal by the operator

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

1

PN 4237530BB

CBC Module

r Contains all the components necessary for CBC analysis

BSV (Blood Sampling Valve) Module

r Contains components associated with the sampling of blood including the aspiration

pumps for pulling sample from the specimen tube into the instrument

r Also contains the sheath tank that supplies the diluent needed for proper sample flow for

differential analysis using VCS technology

Pump Module

r Contains the two Erythrolyse II reagent pumps needed for differential analysis using

VCS technology

1-23

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Right Side of the Main Unit

041993

Main Diluter module

Mixing

module

LASER

ON

Flow Cell module

Modules on the Right Side of the Main Unit

Main Diluter Module

r Contains various components relating to sample dilution and cycling as well as vacuum

and pressure regulators

Flow Cell Module

r Contains the components necessary for analyzing the WBC Diff and Retics using VCS

technology

r Also referred to as the Triple Transducer Module (TTM)

r Flow cell and laser are inside a protective housing

Mixing Module

r Associated with the VCS portion of the system

r Used to mix the whole blood sample with the reagents needed to prepare the sample for

WBC differential analysis using VCS technology

1-24

PN 4237530BB

Back View of the Main Unit

Reagent

manifold

and

connectors

GETTING TO KNOW YOUR INSTRUMENT

MAIN UNIT - HmX Hematology Analyzer with Autoloader

Fans

Power ON/OFF
rocker switch

Plugs for
computer

1

Pneumatic Power Supply

Module on the Back of the Main Unit

Pneumatic Power Supply

r Source of the vacuums and pressures used throughout the instrument

r The compressor/ vacuum pump produces one service adjustable level of air pressure,

60 psi and one nonadjustable level of vacuum, >22" Hg

PN 4237530BB

1-25

GETTING TO KNOW YOUR INSTRUMENT

REAGENTS

REAGENTS

Reagents Connected to the Main Unit

Reagent Recommended Function CBC DIFF Retic

Open Container
Stability

Diluent ISOTON III diluent r Isotonic solution that

dilutes the sample

r Stabilizes cell

membranes

r Conducts aperture

current

r Carries and focuses the

VCS sample stream

r Rinses the system

between samples

CBC Lytic
Reagent

Diff Lytic Reagent Erythrolyse II erythrocyte

Diff Leukocyte
Preservative

Cleaning Agent COULTER CLENZ

LYSE S III diff lytic
reagent

lytic reagent (also called
PAK LYSE)

One of the HmX PAK
reagents

StabiLyse leukocyte
preservative (also called
PAK PRESERVE)

One of the HmX PAK
reagents

cleaning agent

r Disrupts erythrocytes
r Frees hemoglobin
r Reduces cellular debris
r Converts hemoglobin to

a stable cyanide­containing pigment

r Dilutes the sample for

the diff

r Lyses red blood cells
r Reduces cellular debris

r Preserves white blood

cells in their near-native
state for differentiation
using VCS technology

r Cleans and rinses the

diluter parts

r Prevents protein buildup
r Eliminates routine

aperture bleaching











Same as shelf life
(date printed on
the container)

60 Days

60 Days

60 Days

90 Days

1-26

PN 4237530BB

GETTING TO KNOW YOUR INSTRUMENT

Special Reagents Used in Sample Preparation for Retic Analysis

Reagent Recommended Function CBC DIFF Retic

REAGENTS

Open Container
Stability

1

ReticPrep
Reagent A

ReticPrep
Reagent B

New Methylene Blue dye,
special formulation

Clearing reagent
(very dilute sulfuric acid)

r Stains any reticulum

present in the RBCs

r Removes hemoglobin

from the cells without
removing the
precipitated stain-RNA
complex

r Keeps the cell

membrane intact





60 Days

60 Days

Storage and Handling

r All reagents should be stored and used at the laboratory’s ambient room temperature

r Active components may separate (layer) if the reagent has been frozen during transport

or storage → inconsistency of components affects parameter results

r To ensure reagent integrity, treat each reagent container as if it were frozen sometime

during transport or delivery to your institution

r Before using a reagent

t Make sure the reagent is completely thawed

t Gently mix by inversion

t Allow sufficient time for any microbubbles to dissipate

Note: Microbubbles may increase the background count and affect parameter
results.

➤ Changing Reagents Summary

1 Record the New Reagent Information

r From the Main Menu, select Special Functions tt Set Up tt System Set Up tt Reagents

r Enter the lot number and the expiration date or open container stability date,

as applicable

t The date opened automatically changes to today’s date when the lot number is

entered (this is the reason the lot number should always be typed even if it is the
same as the last container)

t Six digits must be entered for the expiration date or open container stability date

Note: Open container stability is stated on the reagent container, when applicable.

r Press Ò to save the information then Ñ to return to the Main Menu

PN 4237530BB

1-27

GETTING TO KNOW YOUR INSTRUMENT

REAGENTS

2 Replace the Reagent Container

r Turn the compressor off

From the Main Menu, select

Fluidics Tests tt Compressor On/Off then press Û; press the ßto select Off and

press Û again

r Open the new reagent container

r Remove the pickup tube assembly from the old container then transfer it directly to the

new container and tighten

Note: If the lower part of the assembly touches you or anything outside the container,
flood that lower part of the assembly with distilled water then wipe it with a lint-free
tissue.

3 Prime the Lines

r From the Main Menu, select Diluter Functions tt Prime Reagents
r Select the reagent that was changed then press Û, the compressor turns on and the

Prime Reagents program activates

Special Functions tt Diagnostics tt Operator Options tt

r Once priming is complete, press Ñ to return to the Main Menu and continue normal

operation

➤ ➤

➤ Replacing a Waste Container Summary

1 Put the Instrument into Standby

r Move the Standby/Reset rocker switch to Standby, position O

2 Turn OFF the Main Power

r Use the Main POWER On/Off rocker switch located on the back of the Main Unit

3 Replace the Waste Container

r Using biohazardous precautions,

t Remove the waste assembly from the full container

t Transfer the waste assembly directly to an empty waste container and tighten

r Dispose of the biohazardous waste according to you laboratory’s protocol

1-28

4 Turn ON the Main Power

r Use the Main POWER On/Off rocker switch located on the back of the Main Unit

5 Put the Instrument into Ready

r Move the Standby/Reset rocker switch to Ready, position |

➤ ➤

PN 4237530BB

OBJECTIVES

When the subject is complete, you will be able to . . .

Startup

r Initiate a Startup.

r Recognize an out-of-limit result on the Startup Summary or System Status Values screen.

r Explain what to do if a Startup result is out of limits.

Clean Cycle

r Initiate a Clean Cycle.

r State the difference between a Clean Cycle and a Shutdown.

Shutdown

r Initiate a Shutdown.

r State how often a Shutdown must be performed.

r State the minimum time the COULTER CLENZ cleaning agent should stay in the

instrument while in Shutdown.

STARTUP / SHUTDOWN

2

2

PN 4237530BB

2-1

STARTUP / SHUTDOWN

OBJECTIVES

NOTES

2-2

PN 4237530BB

STARTUP

r Must be completed before running patient specimens or controls anytime cleaning agent

has replaced diluent in the aperture baths

r During a Clean Cycle, Startup is automatically initiated 30 minutes after completion of

the Shutdown cycle

r Perform quality control checks before running patient specimens

STARTUP SCREENS

Summary Screen

STARTUP / SHUTDOWN

STARTUP

2

PN 4237530BB

r Also referred to as the First Start Up screen because it is the first display that

automatically appears and prints

r Shows a reagent summary on the left and a system check summary on the right

r Autoloader Check prompt only appears on the Summary screen of a HmX Hematology

Analyzer with Autoloader

Reagent Summary

r The reagent summary lists each reagent lot number and expiration date (may be the

open container expiration date, if applicable)

r If a date appears in red numbers, the expiration date is exceeded

System Check Summary

r Shows results on a Pass/Fail basis

r A check that fails appears in red

2-3

STARTUP / SHUTDOWN

STARTUP

System Status Values Screen

r Also called the Second Start Up screen

r Allows an operator to review the detailed system check results
r Can only be viewed by pressing Ê when the Summary screen is displayed

Background Values

r If any Background result is outside of its limits,

t Result is displayed in red
t Press Ë

Repeat Background to redo the background counts

t If the condition still exists, refer to the Special Procedures and Troubleshooting

(SPT) Manual

System Values

r If any of the electronic readings, pressures, vacuums, or temperature readings are outside

of limits,

t Value is displayed in red

t Perform a

Special Functions tt Diagnostics tt Operator Options tt System Test

System Test to confirm

Press Û then Ë Run to initiate the test

t If the condition still exists, refer to the Special Procedures and Troubleshooting

(SPT) Manual

2-4

PN 4237530BB

➤ STARTUP SUMMARY

1 Check Current Instrument Status

r If the power is off, turn it on

r If the Main unit is in Standby, switch it to Ready
r If the DMS monitor is dark, press ß

r If Startup results are already displayed as the result of a Clean Cycle, go to step 3; if not,

enter your three character Operator ID (optional)

t From the Main Menu, press Í

t Type your three character Operator ID
t Press È to return to the Main Menu

2 Perform Start Up

r From the Main Menu, select Diluter Functions tt Start Up
r Press Û

Options

STARTUP / SHUTDOWN

STARTUP

2

3 Review Results

r Once the startup cycles are complete, review the Summary screen and, if necessary, the

System Status Values screen
t If the Background Check fails, press Ê to view the System Status Values screen

and then press Ë

t If Fail appears for any other check, press Ê to view the System Status Values

screen then perform a

Special Functions

Press Û then Ë Run to initiate the test then follow the prompts

r Startup results are not saved, but do print automatically

r Save the Summary and System Status Values screen printouts for documentation

purposes

Repeat Background to redo the background counts

System Test

tt Diagnostics tt Operator Options tt System Test

4 Perform Quality Control Checks

r Perform quality control checks before running patient specimens

➤ ➤

PN 4237530BB

2-5

STARTUP / SHUTDOWN

STARTUP

NOTES

2-6

PN 4237530BB

SHUTDOWN

r Allowing cleaning agent to remain in the instrument a minimum of 30 minutes

r Perform either a Clean Cycle or a Shutdown once every 24 hours that the instrument is

Clean Cycle

r Consists of a Shutdown cycle followed 30 minutes later by a Startup cycle

r Perform quality control checks before running patient specimens

Shut Down

r When the Shutdown cycle is complete, leave the power ON → every 24 hours, the system

r Startup must be completed before running patient specimens or controls

STARTUP / SHUTDOWN

SHUTDOWN

minimizes protein buildup in the instrument

in use

does an autopurge cycle to purge the flow cell and the sample lines with diluent

Note: If you turn the power OFF and the instrument is going to be idle for more than
48 hours, do the Prolonged Shutdown Procedure in the Operator’s Guide, Chapter 5.

2

➤ CLEAN CYCLE SUMMARY

1 Perform the Clean Cycle

r From the Access screen, press Ë CLEAN then press Û

2 Let the Instrument Stand

r Cleaning agent remains in the instrument

r Leave instrument power on

r After 30 minutes, a Startup automatically begins

3 Review Results

r Once the startup cycles are complete, review the Summary screen and, if necessary, the

System Status Values screen
t If the Background Check fails, press Ê to view the System Status Values screen

and then press Ë

t If Fail appears for any other check, press Ê to view the System Status Values

screen then perform a

Special Functions

Press Û then Ë Run to initiate the test then follow the prompts

r Startup results are not saved, but do print automatically

r Save the Summary and System Status Values screen printouts for documentation

purposes

Repeat Background to redo the background counts

System Test

tt Diagnostics tt Operator Options tt System Test

PN 4237530BB

4 Perform Quality Control Checks

r Perform quality control checks before running patient specimens

➤ ➤

2-7

STARTUP / SHUTDOWN

SHUTDOWN

➤ SHUTDOWN SUMMARY

1 Perform Shut Down

r Verify SELECT FUNCTION is displayed on the status line

r From the Main Menu, select
r Press Û

Diluter Functions tt Shut Down

2 Let the Instrument Stand

r Allow cleaning agent to remain in the instrument a minimum of 30 minutes

r Leave instrument power on

Note: If the power is turned off and the instrument is going to be idle for more than
48 hours, do the Prolonged Shutdown Procedure in the Operator’s Guide, Chapter 5.

r Perform the Startup procedures before running patient specimens or controls

➤ ➤

2-8

PN 4237530BB

OBJECTIVES

When the subject is complete, you will be able to . . .

r Set up control files using the

Control set up option.

SET UP OPTIONS

3

3

r Enter data under the

formats, and print options.

r Enter data under the

host computer is in use.

Sample analysis set up option to include flagging limits, display

System set up option including the communications definition if a

PN 4237530BB

3-1

SET UP OPTIONS

OBJECTIVES

NOTES

3-2

PN 4237530BB

SET UP MENU OPTIONS

r From the Main Menu, select Special Functions tt Set Up to access this menu

r

Set Up submenu consists of three options

t Control set up
t Sample analysis set up
t System set up

r All the options available in the Set Up area of the DMS software are listed here

t Each menu item is listed with a short description

t For details, see Chapter 6 of the Operator’s Guide

CONTROL SET UP

r From the Main Menu, select Special Functions tt Set Up tt Control set up

r For additional details, see Chapter 6 of the Operator’s Guide

r Used to set up any of the 20 control files

r Sets up a variety of control files

t CBC/DIFF file

SET UP OPTIONS

SET UP MENU OPTIONS

3

t Latex file

t CBC file

t RETIC file

r Also used to enable or disable the Auto-Stop function

t Although available on both HmX instruments, the Auto-Stop function is more

typically used with a HmX Hematology Analyzer with Autoloader

t

Auto-Stop option ON

Instrument stops and a beeping alarm sounds when one of the following control
error messages occur:

Control Out of Range

Control Expired

File Full

File not Found (CBC/DIFF only)

Disk Drive C: Full

t

Auto-Stop option OFF

Instrument continues analysis when a control error occurs

Setting Up Your Laboratory’s Control Files

r Use the instructions under the Initial Set Up of Control Files Summary heading to set up

your laboratory’s control files

PN 4237530BB

3-3

SET UP OPTIONS

CONTROL SET UP

➤ INITIAL SET UP OF CONTROL FILES SUMMARY

Any Control File can be set up as a:

r LATRON control file (Latex file)
r 5C cell control file (CBC/DIFF file)
r Retic-C cell control file (RETIC file)

Setting Up a LATRON Control File

1 Select the File

r From the Main Menu, select
r Move the cursor to a NOT SETUP file then press Û

2 Type Manual Entries

r Enter the name of the file and your Operator ID

r Enter the Lot # and expiration date from the package insert

Special Functions tt Set Up tt Control set up tt Latex file

3 Verify Host Setting

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r To change, use the ß to toggle between ON and OFF

4 Verify All Information

r Check all entries are correct then press Ò to save and exit the screen

Setting Up a 5C Cell Control File

1 Select the File

r From the Main Menu, select

CBC/DIFF file

r Move the cursor to a NOT SETUP file then press Û

2 Upload the Assay Values

r Insert the 5C cell control diskette into the A: drive of the computer
r Press Í

r Press the function key for the desired level of control

3 Type Manual Entries

r Select the Shift and manually type the Operator ID

Upload Assay Values

Special Functions tt Set Up tt Control set up tt

3-4

4 Verify Host Setting

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r To change, use the ß to toggle between ON and OFF

5 Verify All Information

r Check all entries are correct then press Ò to save and exit the screen

PN 4237530BB

6 Set Up Another Level of Control, if applicable

r Move the cursor to a

r Repeat steps 2 through 6

7 Remove the Diskette from Drive A: (after all needed set ups are complete)

NOT SETUP file then press Û

Setting Up a RETIC File

1 Select the File

r From the Main Menu, select
r Move the cursor to a NOT SETUP file then press Û

2 Type Entries from the Table of Expected Results

r Enter the Lot #, Expiration Date, Shift, and your Operator ID

r Enter the RBC and Retic % values from the assay sheet

Note: If you report Retic number (RET #), it is important that you enter the correct
RBC value from the assay sheet. If you enter the wrong number and then correct it
after running controls, the DMS does not recalculate the incorrect RET # control
results that are stored in the RETIC file.

r If your instrument has the MRV and IRF parameters enabled, enter 99.9 as the

assigned values and expected ranges for these parameters. Use these values until
you establish your own.

Special Functions tt Set Up tt Control set up tt RETIC file

SET UP OPTIONS

CONTROL SET UP

3

3 Verify Host Setting

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r To change, use the ß to toggle between ON and OFF

4 Verify All Information

r Check all entries are correct then press Ò to save and exit the screen

➤ ➤

Note: This summary is only for initial set up of control files; therefore, it is not included in
the Summary Pages. The next time you set up a control file, use the

Using the Default Limits/ Expected Ranges from the Package Insert Summary

to maintain customized expected ranges in a 5C control file. In this case, use the

Management Using Your Laboratory’s Custom Ranges Summary

Control File Management

unless you wish

Control File

.

PN 4237530BB

3-5

SET UP OPTIONS

SAMPLE ANALYSIS SET UP

SAMPLE ANALYSIS SET UP

r From the Main Menu, select Special Functions tt Set Up tt Sample analysis set up

r For additional details, see Chapter 6 of the Operator’s Guide

Action limits

XB limits

r Sets Target Values and Limits, user defined

Definitive flag limits

r These word messages are generated based on user defined limits

High/low flag limits

Note: MRV and IRF parameters appear on this screen when these parameters are enabled.

r These flags are generated based on user defined limits

Laboratory Normal Ranges

Note: MRV and IRF parameters appear on this screen when these parameters are enabled.

r These limits are the default normal ranges for the HmX instruments

r The laboratory’s normal ranges should be entered here for printing on the report

Location list

r Creates a list of common locations

r Operator may then choose from this list when assigning demographics in the Worklist or

when editing in the Data Base

Physician list

r Creates a list of common physicians

r Operator may then choose from this list when assigning demographics in the Worklist or

when editing in the Data Base

Display formats

Screen Labels

Note: MRV and IRF parameters appear on this screen when these parameters are enabled.

3-6

r Makes Primary Identifier selections and allows the operator to change the name of the

label identifiers

PN 4237530BB

SET UP OPTIONS

SAMPLE ANALYSIS SET UP

Parameter Selection

r Enables or disables the Pct, PDW, and RET#

r Enables or disables the MRV and IRF

Reporting Units

Note: MRV and IRF parameters appear on this screen when these parameters are enabled.

r Selects the appropriate reporting units for the laboratory

Delete database

r Deletes all samples in the data base and resets the system

Delete host spooler

r Clears the buffer of results waiting to be transmitted to the host computer

Clear printer spooler queue

r Clears the buffer of results waiting to be transmitted to the printer

3

Print options

Auto Print Format

r Selects ticket or graphics format

Ticket Options

r Selects the options available for the ticket format (if applicable)

r These options include selecting the units (% or 10

(WBC or RBC) or if Suspect and Definitive flags will print

Spooler Priority

r Sets which will print first (Manual, Auto, or Batch)

Graphics Options

r Selects the options available for the graphics format

r These options include the page format (width /font), which scatterplots will print, and

determines if demographics, suspect and definitive flags, units, normal ranges and the
diff box will print

Optional Printer

r Sets the options for a second printer

3

/µL), normal ranges, parameter labels

PN 4237530BB

3-7

SET UP OPTIONS

SYSTEM SET UP

SYSTEM SET UP

r From the Main Menu, select Special Functions tt Set Up tt System set up

r For additional details, see Chapter 6 of the Operator’s Guide

Shift

r Used to separate the control files into different shifts

Reagents

r Updates the reagent log

Institution

r Sets up the banner for the top of each printout

Communication def

r Host computer definition

r Configures the communication format for transfer of sample information to a host

computer

IQAP ID#

r After entering the lab’s participant number in this field, it will attach to the control files

for IQAP reference

Set Date/Time

r Allows the operator to adjust the current date and/or time (for example, daylight savings

time)

Supervisor Password

r Allows the operator to change the supervisor password

Optimize Hard Disk

r Sets the option to initiate the clean up of the DMS hard drive upon power up or resetting

the unit

r See the Special Procedures and Troubleshooting (SPT) Manual for more information

3-8

PN 4237530BB

OBJECTIVES

When the subject is complete, you will be able to . . .

LATRON Primer and Control

r Explain the storage and handling requirements.

r State the open-vial stability.

r Prepare and run LATRON primer and control.

r Recognize an out-of-limits result on the LATRON screen.

r Using the Operator’s Guide, explain what to do if a LATRON primer or control result is

r Explain the statistics associated with the control files and graphs.

5C Cell Control

r Explain the storage and handling requirements.

r State the open-vial stability.

r Define an event.

r State indications of instability or deterioration.

r Prepare and run 5C cell control.

out-of-limits.

QUALITY CONTROL

4

4

r Recognize an out-of-limit result on the 5C control screen.

r Using the Operator’s Guide, explain what to do if a 5C cell control result is out-of-limits.

r Explain the statistics associated with the control files and graphs.

Retic-C Cell Control

r Explain the storage and handling requirements.

r State the open-vial stability.

r Define an event.

r State indications of instability or deterioration.

r Prepare and run Retic-C cell control.

r Recognize an out-of-limit result on the Retic-C control screen.

r Using the Operator’s Guide, explain what to do if a Retic-C control result is out-of-limits.

r Explain the statistics associated with the control files and graphs.

Interlaboratory Quality Assurance Program (IQAP)

r Explain the purpose of the Interlaboratory Quality Assurance Program (IQAP).

PN 4237530BB

4-1

QUALITY CONTROL

OBJECTIVES

Control File Management

r Review numeric and graphic control data for errors and make appropriate corrections.

r Print and/or download control file data.

r Delete individual control runs.

r Delete a control file.

r Properly set up control files for running LATRON, 5C Cell Control, and/or Retic-C Cell

r Explain how to make changes to an existing control file.

Additional QC Checks

r Explain the purpose of Mode-to-Mode Comparison.

r Explain the purpose of a linearity study.

r Explain the purpose of a diff comparison.

XB Analysis

r Explain the purpose of XB Analysis.

Control.

r Explain why only RBC indices are used in the X

Analysis.

B

r Define the terms batch, target values, action limits, non-reportable results, and

non-random sampling as they apply to the X

r State the minimum number of samples for a valid X

r Explain when an X

r Describe the three areas of the X

batch mean table prints automatically.

B

graph.

B

r Identify the problem parameter (or parameters) causing an X

Analysis.

B

batch.

B

batch to be out-of-control.

B

4-2

PN 4237530BB

LATRON PRIMER AND CONTROL

r Daily quality control check to verify performance of the VCS technology TTM

components in both the DIFF and Retic modes

r Must be at room temperature prior to use

t May be stored in the refrigerator but not necessary

t If stored in the refrigerator product must be brought to room temperature before

running

r Instrument aspirates approximately 1.5 mL

LATRON Primer

r Contains a surfactant to remove bubbles and clean the sample tubing and pathway from

the tip of the aspirate probe to and through the flow cell (located inside the TTM)

r Does not need to be mixed

t Vigorous mixing creates microbubbles that may cause increased counts

r Results are automatically saved in the Latex control file

QUALITY CONTROL

LATRON PRIMER AND CONTROL

4

r Can manually print the results if desired

LATRON Control

r Contains specific size latex particles with a predetermined Volume, Conductivity and

Laser Light Scatter (measurements determined using VCS technology)

r Control is used to verify

t Flow cell alignment

t Gains for flow cell volume, conductivity and laser light scatter

t CV for flow cell volume, conductivity and laser light scatter

r Latex particles settle to the bottom of the vial

t Operator must gently invert the vial to resuspend particles

t Vigorous mixing creates microbubbles that may affect results

r Control must not be exposed to direct sunlight or temperatures above 30°C (86°F);

keep the vials away from windows and heaters

r Results are automatically saved in the Latex control file

r Can manually print the results if desired

PN 4237530BB

4-3

QUALITY CONTROL

LATRON PRIMER AND CONTROL

Reviewing LATRON Control Results

On the Control Run Screen

r Mean Channel result for Volume, Conductivity, and Scatter

t An

H or L is displayed when a result is outside the limits (flag does not appear in red

as its does on the Startup screen)

r CV results for Volume, Conductivity, and Scatter

t An

H is displayed when a result is above the upper limit

Using Î Graph . . . a Control Run Screen Option

r Semi-quantitative graphs

r Mean channel and %CV graphs of the last 10 runs
r Press Î as many times as necessary to scroll to the graphs you want to view

Using Review or Report, Latex . . . a Control Menu Option

r Comprehensive display of all runs, up to 100 runs per file

r Allows operator to view the Mean Channel and CV data

t An

t An

H or L is displayed when a Mean Channel result is outside the limits

H is displayed when a CV percentage result is above the upper limit

r Use the é and è keys to move between DIFF and Retic data

r Use the

F6-Remove/Restore option as a data management tool

Using Graphs . . . another Control Menu Option

r Levey-Jennings graphs

r Plot point for each result, up to 100 runs per file

r Ideal for spotting trends and shifts

4-4

r Use Î

Additional Graphs to move between DIFF and Retic graphs

PN 4237530BB

➤ Running LATRON Primer and Control Summary

1 Status for Proceeding

r Ensure Startup is complete

r LATRON Primer and Control must be at room temperature

2 Run LATRON Primer

At the DMS

r From the Main Menu, select
r If the LATRON file does not appear, press Ê File and select your current Latex file

Controls tt Control Run

QUALITY CONTROL

LATRON PRIMER AND CONTROL

4

r Press Ë

At the Diluter

r Cycle LATRON Primer in the Secondary mode

t Immerse the aspirator tip completely in the Primer

t Do not place the tip against the side of the bottle

t Press and release the sample bar

t Listen for the beep or verify the status line message changes from Aspirating to

Reviewing Primer Results at the DMS

r Check the count for both DIFF and Retic when the analysis is complete

r If both counts are

t Press È to remove the Primer Run window

t Go to step 3 and run LATRON Control

r If either or both counts are

t Rerun the LATRON Primer

t Evaluate the new count and troubleshoot if needed

Run then Ì PRIMER

Diluting before removing the bottle

≤500,

≥500,

PN 4237530BB

3 Run LATRON Control

At the DMS

r If necessary, press È to close the Primer Run window
r Press Ë

Run then press Ë CONTROL (SECONDARY)

4-5

QUALITY CONTROL

LATRON PRIMER AND CONTROL

At the Diluter

r Gently invert the LATRON Control bottle 5 to 8 times

r Cycle LATRON Control in the Secondary mode

t Immerse the aspirator tip completely in the control

t Do not place the tip against the side of the bottle

t Press and release the sample bar

t Listen for the beep or verify the status line message changes from Aspirating to

Diluting before removing the bottle

Reviewing Control Results at the DMS

r Review results once the run appears on the Control Run screen

r If a result is out-of-limits, repeat the entire process beginning with LATRON Primer

r If the results of two control runs are unacceptable,

t Follow your laboratory’s protocol

or

t Refer to the

When LATRON is Out of Limits table in the Operator’s Guide

r Compare the results of this run with previous runs, as desired

t To evaluate stored numerical data, select

Controls tt Review or Report

Note: Use the é and è keys to move between DIFF and Retic data.

t To evaluate Levey-Jennings graphs, select

Controls tt Graphs

➤ ➤

4-6

PN 4237530BB

5C CELL CONTROL

r Material for quality control of CBC and DIFF parameters

r 5C Cell Control is assayed only for Primary mode

r Three levels of control with varying mixtures of normal and abnormal values: Normal,

Abnormal I, and Abnormal II

Storage

r Control must be stored at 2 to 8°C (35 to 46°F)

r Storage of the control product in the cap down (inverted) position is not recommended

t Might require additional mixing for complete resuspension of cellular components

Proper Handling

r Do not write an open tube date or initials in the white space between the bar code and

the tube’s cap

t Bar-code reader may not be able to properly read the barcode if marks are present in

this white space

QUALITY CONTROL

5C CELL CONTROL

4

t When the bar-code label cannot be read, the control is stored as a sample in the

Sample Analysis data base rather than in its proper control file

Prepare 5C Cell Controls according to the Package Insert Instructions

r Warm control vials at ambient temperature for 10 to 15 minutes before mixing

r Mix gently by hand using the 8 x 8 x 8 method twice

t After the second mixing, check the sides and bottom of the tube to verify the control

is mixed completely

t Overmixing causes hemolysis which indicates product deterioration

r Do not use mechanical mixers or rotators

r Return to the refrigerator within 30 minutes to ensure stated open-vial stability

Stability

Open-Vial Stability

r Open-vial stability is 13 days or 13 events (whichever comes first)

r An event occurs anytime an operator completes the following sequence:

t Removes a control vial from the refrigerator

t Allows the control vial to stand at room temperature 10 to 15 minutes

t Mixes the control vial gently by hand using the 8 x 8 x 8 method two times

t Aspirates sample

t Returns the control vial to the refrigerator within 30 minutes

PN 4237530BB

r MCV and/or RDW parameters may show trending through the product’s shelf life;

however, this is inherent to the product and should not be considered an indicator of
product instability

4-7

QUALITY CONTROL

5C CELL CONTROL

Indications of Instability

r A slight pink color to the supernatant is normal

r Inability to obtain expected values in the absence of known instrument problems or

Running 5C Cell Control

Control Run Option

r Using the

r Only use this option to run

gross hemolysis (darkly colored supernatant) indicates deterioration of the control

Control Run option to process 5C cell controls is not recommended

t LATRON Primer and Control in the Secondary (Open-Vial) mode

t Retic-C cell controls in the Secondary (Open-Vial) mode

t Control vials with damaged bar-code labels

Note: We recommend control vials with damaged bar-code labels be processed in
the Primary (Closed-Vial) mode using the

Bar-Code Labels

procedure in Chapter 2 of the Operator’s Guide.

Cycling Commercial Cell Controls without

t Commercial cell controls without bar-code labels

Note: We recommend these controls be processed in the Primary (Closed-Vial)
mode; see the

Cycling Commercial Cell Controls without Bar-Code Labels procedure

in Chapter 2 of the Operator’s Guide.

Recommendations for Running 5C Cell Controls

r Control tubes may be run in any order

r Run cell controls in the Primary mode in

Sample Analysis

t Will not see the control results displayed on the Run Samples screen

t Continues to display the last patient sample processed

t Bar-code label on the control tube directs results to the correct file

r To use the Secondary (Open-Vial) mode for running 5C cell control, your laboratory

must determine its own means and expected ranges for each parameter and set up a
control file using these values

4-8

PN 4237530BB

➤ Running 5C Cell Control Summary

1 Getting the DMS Ready

QUALITY CONTROL

5C CELL CONTROL

4

If SELECT FUNCTION is displayed

r From the Main Menu, select Sample

Analysis

Note: Preparation for cycling in the
Primary mode with the DIFF mode
ON begins automatically.

tt Run Samples

If SELECT FUNCTION is not displayed

r From the Main Menu, select Sample

Analysis tt Run Samples

r Press Ë Run
r If DIFF mode is OFF, press Ñ STOP

then press Î DIFF ON / OFF

r Is the PRIMARY: SAMPLE ANALYSIS

prompt at the top of the F3-Run
window?

t If yes, press È
t If no, press Ê

2 Prepare Controls according to the Package Insert

r Warm controls at room temperature 10 to 15 minutes

r Mix each control tube using the 8 x 8 x 8 method twice

t Do not use a mechanical mixer!

t Do not write an open tube date or your initials in the white space between the bar

code and the tube’s cap

3 Run Controls in the same manner as Patient Samples

START PRIMARY

If using a HmX Hematology Analyzer with Autoloader

r Load the control tubes into a cassette

t Load in any order

t Verify the bar-code label is facing upward

r Place the cassette in the loading bay

If using a HmX Hematology Analyzer

r Scan the bar-code label of the control tube you wish to run

Note: Control levels may be processed in any order.

r After a successful read, insert the control tube through the entry port into the carousel

r Repeat for each control tube

PN 4237530BB

4-9

QUALITY CONTROL

5C CELL CONTROL

4 Review Results

If using a HmX Hematology Analyzer with Autoloader

r To verify control results are stored in the control file, select

r If the bar code was not facing up properly or if the bar code was not read because it is

For both the HmX Hematology Analyzer with Autoloader and the HmX Hematology Analyzer

r If a result is out-of-limits,

r Compare the results of this run with previous runs, as desired

Controls tt Review or Report

damaged, control results are stored in the patient data base

t If the bar code was not facing up, position it correctly and run the control again

t If the bar code is damaged, see the

Bar-Code Labels

heading in the Operator’s Guide Startup and Controls chapter

Cycling Commercial Cell Controls without

t Follow your laboratory’s protocol

or

t Refer to the

When CBC/DIFF Control is Out of Limits table in the Operator’s Guide

t To evaluate stored numerical data, select

Controls tt Review or Report

t To evaluate Levey-Jennings graphs for the presence of shifts or trends, select

Controls tt Graphs

r Print results from the Control Run screen, as desired

➤ ➤

4-10

PN 4237530BB

RETIC-C CELL CONTROL

r Three levels: Level I, Level II and Level III

r Controls can only be analyzed after sample preparation is completed using the

COULTER ReticPrep Reagent Kit

r Used for monitoring the Coulter method of reticulocyte analysis which uses VCS

technology

r Cannot be used to control the manual method

Storage

r Control must be stored at 2 to 8°C (35 to 46°F)

r Store open vials upright in the rack provided

t Storage of the control product in the cap down (inverted) position might require

additional mixing for complete resuspension of cellular components

Proper Handling

Prepare according to the Package Insert Instructions

r Warm at room temperature (20 to 25°C) for 15 minutes before mixing

QUALITY CONTROL

RETIC-C CELL CONTROL

4

r Mix gently by hand using the 8 x 8 x 8 method once

t After mixing, check the sides and bottom of the vial to verify the control is mixed

completely

t Overmixing causes hemolysis which indicates product deterioration

r Do not use mechanical mixers or rotators

r Return to the refrigerator within 30 minutes to ensure stated open vial stability

Stability

Open-Vial Stability

r Open-vial stability is 30 days or 30 events (whichever comes first)

r An event occurs anytime an operator completes the following sequence:

t Removes a control vial from the refrigerator

t Allows the control vial to stand at room temperature 15 minutes

t Mixes the control vial gently by hand using the 8 x 8 x 8 method (one time)

t Pipettes control sample from the vial

t Returns the control vial to the refrigerator within 30 minutes

Indications of Instability

r A pink to light red supernatant is normal

r Moderate to marked hemolysis indicates deterioration of the control, usually due to

overmixing

PN 4237530BB

4-11

QUALITY CONTROL

RETIC-C CELL CONTROL

Running Retic-C Cell Control

r Use the Control Run option for processing

r Prepare a dilution using the COULTER ReticPrep Reagent Kit before analysis

r Run in the Secondary mode

Special Reagents Needed for Retic Analysis

Reagent Recommended Function CBC DIFF Retic

Open Container
Stability

ReticPrep
Reagent A

ReticPrep
Reagent B

New Methylene Blue
dye, special
formulation

Clearing reagent
(very dilute sulfuric
acid)

r Stains any reticulum

present in the RBCs

r Removes hemoglobin

from the cells without
removing the precipitated
stain-RNA complex

r Keeps the cell membrane

intact





60 Days

60 Days

4-12

PN 4237530BB

➤ Running Retic-C Cell Control Summary

1 Prepare Controls according to the Package Insert

r Warm controls at room temperature 10 to 15 minutes

r Mix each control tube using the 8 x 8 x 8 method once

r Do not use a mechanical mixer

2 Preparing the Control

r For each control tested, label two 12 x 75 mm test tubes "A" and "B"

r Place 4 drops of Reagent A into tube "A"

r Dispense 50 µL of the well mixed control into tube "A"

r Gently mix tube "A"

t Let the tube stand for a minimum of 5 minutes and a maximum of 60 minutes

3 Getting the DMS Ready

r From the Main Menu, select Controls tt Control Run
r Press Ê File and select the desired file

QUALITY CONTROL

RETIC-C CELL CONTROL

4

r Press Ë

Run, Ë CONTROL (SECONDARY)

4 Run Controls in the Same Manner as Patient Samples

r Gently mix the "A" tube

r Pipette 2 µL of the control/stain mixture from tube "A" into the bottom of tube "B"

r Place tube "B" with the control/stain aliquot at an angle under the tip of the Reagent B

dispenser

r Dispense 2 mL of Reagent B into tube "B"

r Do not mix

r Wait 30 seconds then analyze the retic preparation you just made

t Immerse the aspirator tip into the retic preparation

t Press and release the sample bar

t Listen for the beep or verify the status line message changes from Aspirating to

Diluting before removing the tube

5 Review Results

r If a result is out-of-limits,

t Follow your laboratory’s protocol

or

t Refer to the

r Compare the results of this run with previous runs, as desired

t To evaluate stored numerical data, select

When Retic Control is Out of Limits table in the Operator’s Guide

Controls tt Review or Report

PN 4237530BB

t To evaluate Levey-Jennings graphs for the presence of shifts or trends, select

Controls tt Graphs

➤ ➤

4-13

QUALITY CONTROL

REVIEWING CONTROL RESULTS

REVIEWING CONTROL RESULTS

Using Control Menu Options to Review 5C Cell Control or Retic-C Results

Note: MRV and IRF parameters appear on the retic screens when these parameters are
enabled.

On the Control Run Screen

r Compares control results to expected ranges

t An

Using Î Graph . . . a Control Run Screen Option

r Semi-quantitative graphs

r Displays results of the last 10 runs
r Press Î as many times as necessary to scroll to the graphs you want to view

Using Review or Report, CBC/DIFF (or RETIC) . . . a Control Menu Option

r Comprehensive display of all runs, up to 100 runs per file
r Use the é or è key to view additional parameters

H or L is displayed when a result is outside the limits (flag does not appear in red

as it does on the Startup screen)

r Allows operator to review all parameter results

t Values for Assay and Limits are entered when a control file is set up

t Parameter results are listed individually and by average (MEAN); ongoing 2SD and

CV values are also provided

t If the CV result is greater than 20%, a +++++ code is displayed

Note: +++++ code replacing basophil parameter results is typical.

t Out-of-control results have an

r Use the

F6-Remove/Restore option as a data management tool

H or L next to the result

Using Graphs . . . another Control Menu Option

r Levey-Jennings graphs

r Plot point for each result, up to 100 runs per file

r Ideal for spotting trends or shifts

4-14

PN 4237530BB

TABLE OF QUALITY CONTROL MATERIALS

Recommended
QC material Function CBC DIFF Retic

QUALITY CONTROL

TABLE OF QUALITY CONTROL MATERIALS

4

Open Vial
Stability

LATRON Primer Cleans and prepares the pathway for

running LATRON Control

LATRON Control Checks the functioning of the VCS

Technology

5C Cell Control Checks recovery of CBC and Diff

parameters

Retic-C Cell Control Checks recovery of Retic parameter

S-CAL Calibrator Adjusts the accuracy of the CBC

parameters

LIN-C Cell Control Checks the linear recovery of the CBC

parameters

IQAP (Interlaboratory Quality Assurance Program)

r The Coulter Interlaboratory Quality Assurance Program is a free service offered to all

regular users of 4C, 4C PLUS, 5C and Retic-C cell controls as well as users of LIN-C
linearity controls

r It complements a laboratory’s in-house quality control program by providing peer group

comparisons for each lot number of a given control product run on the same instrument
type

r The assessment is completely independent of the assay value issued when the product

was supplied

r A separate IQAP manual (PN 4206266) is available with information on enrollment, data

submission, understanding the IQAP report, and troubleshooting IQAP problems











30 Days

30 Days

13 Days/Events

30 Days/Events



1 Hour

7 Days

PN 4237530BB

4-15

QUALITY CONTROL

CONTROL FILE MANAGEMENT

CONTROL FILE MANAGEMENT

r Once a control file is initially set up, the file:

t Never reverts back to a

t Is considered an existing control file

r Two types of existing control files

t Control file that contains control run data (may be either current or old data)

t Control file with no stored control run data because the file is either newly set up or

has had all its control runs deleted from it

Existing Control Files Currently In Use

Reasons an Operator may need to Access a Control File that is Currently in Use

r To correct a typographical error

r To edit an assigned value (obtained from the Table of Expected Results) to a running

mean (established by the laboratory)

NOT SET UP status

4-16

PN 4237530BB

➤ MAKING CHANGES TO A CONTROL FILE CURRENTLY IN USE

Use only if you want to make a change in a control file that is currently in use. This summary
should be used when changing individual
entering a running mean or correcting a typographical error. If you want to make a set up
change (such as changing the lot number), use the appropriate Control File Management
Summary.

1 Select the File

r From the Main Menu, select Special Functions tt Set Up tt Control set up

r Select the type of file and then select the existing file you want to change

2 Answer the Questions

r Recompute Existing Runs ?

t Press ß to answer Ye s then press Û

t Yes automatically adjusts the statistics and graphs to the change

t Operator must toggle to Ye s to look at the screen even if no changes are made

items in a previously set up control file, such as

QUALITY CONTROL

CONTROL FILE MANAGEMENT

4

r Use Default Limits / Expected Range ?

t To maintain laboratory custom ranges, press Û to answer No
t To use Expected Ranges (from the package insert), press ß to answer Ye s then

press Û

3 Make the Changes

r Enter the new information

4 Verify All Changes

r Check all entries are correct then press Ò to save and exit the screen

➤ ➤

PN 4237530BB

4-17

QUALITY CONTROL

CONTROL FILE MANAGEMENT

Existing Control Files No Longer In Use

Reason an Operator may need to Access an Existing File that is No Longer in Use

r To overwrite the file with the set up information of another lot number

Note: Management of these control files differs depending on whether the laboratory
wants to use the default limits /expected ranges (from the Table of Expected Results on
the Beckman Coulter package insert) or the laboratory wants to use their own custom
ranges (expected ranges established by the laboratory).

To evaluate the difference of control file management for a laboratory using the default
limits / expected ranges from the package insert versus a laboratory using their own
custom ranges, see a comparison of procedures on the next page.

4-18

PN 4237530BB

CONTROL FILE MANAGEMENT

Management of Existing Control Files No Longer In Use . . . a Comparison

QUALITY CONTROL

4

Using Default Limits/ Expected Range

(from the package insert)

1. Control file is initially set up using a

NOT SETUP file

2. Run controls for the month 2. Run controls for the month

3. Using the
review stored control data and use the

F6-Remove/Restore option to remove

any invalid runs

4. Print the control file 4. Print the control file

5. Download the file for IQAP,
if applicable

6. Delete all the control runs using the

F8-Delete File option

Review or Report option,

Using Custom Ranges
(established by your laboratory)

1. Control file is initially set up using a

NOT SETUP file

Operator types over the default limits /
expected ranges with their laboratory’s
own established ranges

3. Using the
review stored control data and use the

F6-Remove/Restore option to remove

any invalid runs

5. Download the file for IQAP,
if applicable

6. Set up the new lot number of control

a. Answer the following questions:

Question 1:
Recompute Existing Runs ?

Review or Report option,

7. Set up a new lot in this file either now
or in the future

r Press ß to toggle to Ye s

then press Û

r Yes automatically adjusts the

statistics and graphs to the
change (operator must toggle
to Yes to look at the screen even
if no changes are made)

Question 2:

Use Default Limits/ Expected Range ?

r Pressing Û to answer No

maintains the laboratory’s
custom ranges

b. Set up the new lot information

7. Before
access the
delete all the control runs using the

F8-Delete File option

starting to run the new control,

Review or Report option and

PN 4237530BB

4-19

QUALITY CONTROL

CONTROL FILE MANAGEMENT

➤ CONTROL FILE MANAGEMENT SUMMARY
(Using the Default Limits/ Expected Range from the Package Insert)

Note: To maintain customized expected ranges in a control file, use the Control File

Management Using Your Laboratory’s Custom Ranges Summary

Review the Numeric Control Data and Graphs, if applicable

1 Locate the Control File

r From the Main Menu, select
r Press Ê File and select the file for review then press Û

2 Review the Graphs

r Using Î

Additional Graphs review all graphs noting any trends, shifts or plot points

inside the red area

Controls tt Graphs

.

r Press È then R to switch to the

3 Review Numeric Data

r Review %CV of all parameters (press é to see additional parameters)
r If a CV is high, use å and examine each run for results mistakenly run into

the file (the graph review should correlate)

r Delete any mistakes from the file using Î

Print / Download the Control File Data

r From the Review or Report screen, press Ì to automatically print all parameters

and all runs

r If desired, press È then G then Ì to print all graphs

r Download IQAP data, as needed

Delete the Control File Data

1 Go to Control Review Screen

r From the Main Menu, select
r Press Ê File and select the file you want to delete then press Û

Review or Report option

Remove/Restore

Controls tt Review or Report

4-20

2 Delete the Control File Data

r Press Ð

Delete File

r Press ß to toggle to Ye s
r Press Û to confirm and delete the control file data

Set Up the New Lot Number of Control

Any Control File can be set up as a:

r 5C cell control file (CBC/DIFF file)

r LATRON control file (Latex file)

r Retic-C cell control file (RETIC file)

PN 4237530BB

Setting Up a 5C Cell Control File

1 Select the File

r From the Main Menu, select

r Move the cursor to a NOT SETUP file or an inactive file where the control run data is

deleted then press Û

2 Upload the Assay Values

r Insert the 5C cell control diskette into the A: drive of the computer

QUALITY CONTROL

CONTROL FILE MANAGEMENT

Special Functions tt Set Up tt Control set up tt CBC/DIFF file

4

r Press Í

r Press the function key for the desired level of control

3 Type Manual Entries

r Select the Shift and manually type the Operator ID

4 Verify All Information

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r Check all entries are correct then press Ò to save and exit the screen

5 Set Up Another Level of Control, if applicable

r Move the cursor to a

deleted then press Û

r Repeat steps 2 through 5

6 Remove the Diskette from Drive A: (after all needed set ups are complete)

Upload Assay Values

NOT SETUP file or an inactive file where the control run data is

Setting Up a LATRON Control File

1 Select the File

r From the Main Menu, select

r Move the cursor to a NOT SETUP file or an inactive file where the control run data is

deleted then press Û

Special Functions tt Set Up tt Control set up tt Latex file

PN 4237530BB

2 Type Manual Entries

r Enter the name of the file and your Operator ID

r Enter the Lot # and expiration date from the package insert

3 Verify All Information

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r Check all entries are correct then press Ò to save and exit the screen

4-21

QUALITY CONTROL

CONTROL FILE MANAGEMENT

Setting Up a RETIC File

1 Select the File

r From the Main Menu, select

r Move the cursor to a NOT SETUP file or an inactive file where the control run data is

deleted then press Û

2 Type Entries from the Table of Expected Results

r Enter the Lot #, Expiration Date, Shift, and your Operator ID

r Enter the RBC and Retic % values from the assay sheet

Note: If you enter the wrong RBC value and then correct it after running controls,
the DMS does not recalculate the incorrect RET # control results stored in the
RETIC file.

3 If the MRV and IRF Parameters Are Enabled

r Enter 99.9 for MRV and IRF assigned values and expected ranges if customized

values are not established

Special Functions tt Set Up tt Control set up tt RETIC file

4 Verify All Information

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r Check all entries are correct then press Ò to save and exit the screen

➤ ➤

4-22

PN 4237530BB

➤ CONTROL FILE MANAGEMENT SUMMARY
(Using Your Laboratory’s Custom Ranges)

Use this summary only if you want to maintain the customized expected ranges previously
entered in an existing control file (typically a 5C control file).

Review the Numeric Control Data and Graphs, if applicable

1 Locate the Control File

r From the Main Menu, select
r Press Ê File and select the file for review then press Û

2 Review the Graphs

r Using Î

points inside the red area

r Press È then R to switch to the

3 Review Numeric Data

r Review %CV of all parameters (press é to see additional parameters)

Additional Graphs review all 20 graphs noting any trends, shifts or plot

Controls tt Graphs

Review or Report option

QUALITY CONTROL

CONTROL FILE MANAGEMENT

4

r If a CV is high, use å and examine each run for results mistakenly run into

the file (the graph review should correlate)

r Delete any mistakes from the file using Î

Print / Download the Control File Data

r From the Review or Report screen, press Ì to automatically print all parameters

and all runs

r If desired, press È then G then Ì to print all 20 graphs

r Download IQAP data, as needed

Changing the Existing File

1 Select the File

r From the Main Menu, select

r Select the existing file you want to change

2 Answer the Questions

r Recompute Existing Runs ?

t Press ß to answer Ye s then press Û

t Yes automatically adjusts the statistics and graphs to the change (operator must

toggle to Ye s to look at the screen even if no changes are made)

r Use Default Limits / Expected Range ?

t Press Û to answer No (maintains your laboratory’s custom ranges)

Remove/Restore

Special Functions tt Set Up tt Control set up tt CBC/DIFF file

PN 4237530BB

4-23

QUALITY CONTROL

CONTROL FILE MANAGEMENT

3 Upload the 5C Control Assay Values

r Insert the 5C cell control diskette into the A: drive of the computer
r Press Í

r Press the function key for the desired level of control

4 Type Manual Entries

r Select the Shift and manually type the Operator ID

5 Verify All Information

r Make sure the Host transmit setting correlates with your laboratory’s protocol
r Check all entries are correct then press Ò to save and exit the screen

6 Set Up Another Level of Control, if applicable

r Select another

r Repeat steps 2 through 6

Upload Assay Values

CBC/DIFF file you want to change

7 Remove the Diskette from Drive A: (after all needed set ups are complete)

IMPORTANT Risk of misleading control results. Old control runs remaining in a newly set up control file are

included in the statistical data for the new file. Delete all controls runs before starting to run the new control.

Delete the Control File Data

1 Go to Control Review Screen

r From the Main Menu, select

Controls tt Review or Report

r Press Ê File and select the file you want to delete then press Û

2 Delete the Control File Data

r Press Ð

Delete File

r Press ß to toggle to Ye s
r Press Û to confirm and delete the control file data

➤ ➤

4-24

PN 4237530BB

ADDITIONAL QC CHECKS

Mode-to-Mode Comparison

r Ensures both the Primary and Secondary aspiration modes recover similar values

r Minor differences between the Primary and Secondary modes are due to differences in

the flow characteristics of the aspiration pathways

r 5C cell control is assayed for Primary mode only

r Recommended procedure is located in Chapter 2 of the Operator’s Guide

r The mode to mode limits stated in the Reference manual are established using 10 normal

bloods measured in triplicate (3 consecutive runs each); these limits should not
necessarily be used as limits for a single sample used to check differences between modes

Linearity Checks

r Linearity limits apply only to WBC, RBC, Hgb, and Plt

r Uses various concentrations of blood to verify the reportable range from very low to very

high values

r Linearity can be performed using whole blood or a commercial product such as

COULTER LIN-C linearity control

r Coulter publishes performance specifications in the Reference Manual, however, a

laboratory may be required by a regulatory agency to perform an independent procedure

r When running very low concentrations in the Primary mode, blood detectors must be

disabled prior to the run

Special Functions tt Diagnostics tt Operator Options tt BSV Tests tt Blood Detector ON/OFF

QUALITY CONTROL

ADDITIONAL QC CHECKS

4

Diff Comparison

r Perform manual differentials as a measure of good QC practice or as recommended by

your laboratory, state, and federal protocols

r Manual differentials are performed to verify the automated differential

r Checks the full differential including:

t Reagents

t Mixing process in the mixing chamber

t Sheath and sample pressures

Note: LATRON control checks the VCS technology and the integrity and alignment
of the flow cell.

r For details, see the Differential Comparison Procedure in Appendix B of the Reference

Manual

PN 4237530BB

4-25

QUALITY CONTROL

ADDITIONAL QC CHECKS

XB Analysis

r XB X = Mean

r Pronounced x-bar-bee

r Appears on the DMS screen as XB

r XB will default to ON if instrument is reset

XB Analysis, a Quality Control Tool

r XB Analysis is a quality control method that allows a laboratory to continuously monitor

the performance of their automated hematology system and thus control the quality of
their results

r Any method used for quality control must use a material that meets two requirements

t Material must be stable

t Material must be similar in content to the patient samples that will be analyzed

r X

r No additional cost to the laboratory because the method uses patient sample results

Analysis meets these requirements

B

t Uses the patient samples themselves as a material so the similarity requirement is

t Uses the red blood cell indices (MCV, MCH, and MCHC) so the stability

B = Bull (for Brian S. Bull, M.D.)

met

requirement is met

RBC Indices

r MCV, MCH, and MCHC are relatively stable parameters

t RBC indices are very tightly controlled by the body because the red cells function

best within a very narrow range of size and hemoglobin content

t Other parameters such as the white blood cells and platelets tend to have a wider

physiological range and are, therefore, not as predictable as the red cell indices

r Are typically stable for an individual patient from day to day

r Are stable for a patient population over time

t Many hospitalized patients have been investigated and it has been found that there

is no significant day-to-day or week-to-week variability in the mean of their indices

Target Values

r A constant for each RBC index (MCV, MCH, or MCHC)

r Target values should reflect the entire patient population of the laboratory

t The patient population of a general hospital usually includes samples from all

patient age groups, disease states and many hematologically “normal” samples

t A patient population that includes only one age group or only one disease state will

yield different target values than a patient population that includes all groups

4-26

PN 4237530BB

QUALITY CONTROL

ADDITIONAL QC CHECKS

r As long as the patient population remains constant, the target values of each index also

remain constant

r If the patient population changes, the mean of an index may also change and needs to be

reevaluated

Dr. Bull's Target Values

r Default starting values

t MCV = 89.5

t MCH = 30.5

t MCHC = 34.0

r Each laboratory should begin with these target values and then evaluate and adjust them

for their own patient population

Getting Started

Enter Target Values and Action Limits

r Target values and action limits must be entered in the DMS:

Special Functions tt Set Up tt Sample Analysis Set Up tt Action Limits tt XB Limits

4

r Use either the suggested target values or the target values established by your laboratory

r 3% action limits are suggested

Turning the XB Option ON

r X

Analysis is done automatically by the DMS only if the option is turned on

B

r On the Run Samples screen, check the Status line

t

XB↑ indicates the X

XB↓ indicates the X

t

Analysis is turned ON

B

Analysis is turned OFF

B

r To change the setting,

t

Sample Analysis tt Run Samples; press Í Optns then Ê to change XB ON/OFF setting

r X

Analysis is automatically turned OFF when the Run Samples ÏDisplay Only option

B

is ON

Using the XB Analysis

When XB function is turned on, the

t DMS stores the RBC results of all patient samples as they are cycled

t X

Analysis is performed on small sets of 20 patient results at regular intervals

B

(each patient set is referred to as a batch)

PN 4237530BB

r Stored results (RBC, Hgb, Hct, MCV, MCH, and MCHC) are displayed on the Current XB

Batch table:

Sample Analysis tt XB tt Current XB Batch

r Of the displayed results, only the MCV, MCH, and MCHC parameters are used in the

analysis

4-27

QUALITY CONTROL

ADDITIONAL QC CHECKS

r Having the other RBC parameters displayed allows the operator to judge the validity of

the sample results when an out-of-limits situation occurs

r When the batch of 20 patient samples is completed, the DMS performs the X

and determines the batch mean of each index (MCV, MCH, and MCHC)

t Method for obtaining the batch mean is rather complicated, but the calculation is

t This batch mean is not a simple average value of the patients’ indices, but a type of

r DMS then compares each batch mean to its expected target value

Analysis

B

done automatically by the DMS

“weighted moving average” that statistically allows the small batch of 20 patient
samples to appear as if it were a larger set of approximately 100 samples

t Results are displayed on the XB Batch Means table:

Means

Sample Analysis tt XB tt XB Batch

t If the batch mean is inside the expected action limits, the batch is said to be IN

t Instrument is functioning properly

t

XB↑ status message remains white to indicate the last completed batch was

inside the action limits

t If the batch mean is outside the expected action limits, the batch is said to be OUT

t One or more of the three indices did not come close enough to the expected

target values

t An

t

H or L flag appears beside the out-of-limit results

XB↑ status message turns red to indicate the last completed batch was outside

the action limits

t

XB↑ status message will return to white when the next batch of XB is IN

Reviewing XB Data

Current XB Batch

r Stores RBC parameter results when X

r When a batch of 20 samples is collected, the DMS performs the X

calculates the batch mean for MCV, MCH, and MCHC

t The system automatically excludes samples that do not yield numeric results such

as partial aspirations

r Option primarily used for reviewing individual sample results to identify sample related

problems such as non-reportable results or non-random sampling

t Once the batch is completed (20 patient samples are accumulated), individual

samples cannot be deleted

t Deleted sample results and partial aspiration codes are displayed and consume one

of the 20 sample spaces; however, these results are not used in the X
calculation

Analysis is turned on

B

Analysis and

B

batch mean

B

4-28

t A maximum of 5 samples may be deleted from the current batch prior to

completion

t A minimum of 15 samples are required to calculate a batch mean

PN 4237530BB

QUALITY CONTROL

ADDITIONAL QC CHECKS

XB Batch Means Option

r Used to view the calculated batch means for the last batch of 20 samples collected

r Also provides the percent difference between the calculated batch mean and its

corresponding target value

r If a percent difference is outside the action limit, the parameter is flagged with an

r May be used to identify the affected RBC indices and to determine the direction and

amount of the change

r After the first 20 batches are completed, this option always displays the last 20

completed batches

t Provides a history of recent batch means which may serve as an aid during the

troubleshooting process

t After the 20

results are deleted to make space for the last completed batch results

XB Graphs

r Three graphs, one for each index

r Used to view the batch means in relationship to the target value and action limit of the

corresponding index

r Graphs are good for identifying trends and shifts

r Each graph contains three areas

th

batch is completed, the table begins to rollover where the oldest batch

H or L

4

t A central white line representing the actual target value

t A black area representing the acceptable range

t An upper and lower red line represent action limit boundaries

r After the first 20 batches are completed, this option always displays the plot points for

the last 20 completed batches

t Provides a history of recent batch means which may serve as an aid during the

troubleshooting process

t After the 20

batch results are deleted to make space for the last completed batch results

th

batch is completed, the graph begins to rollover where the oldest

What Causes a Batch to go “Out-of-Limits”?

r Change in the patient population

t One or more types of patients added or removed from the total patient population

mix

t Non-reportable results where a batch of patients is biased by short samples,

physiologically impossible results and/or erroneous data accumulated before a
reagent or instrument problem was identified and solved

t Non-random patient sampling where a batch of patients is biased by several

abnormal patients of one particular type (oncology, neonatal and so forth)

r An instrument problem may exist

r A calibration problem may exist

r A reagent problem may exist

PN 4237530BB

4-29

QUALITY CONTROL

ADDITIONAL QC CHECKS

Troubleshooting when an XB Batch is “Out”

Consider a Change in the Patient Population

r Is there a change in the overall patient population?

t One or more new patient types were added to the population

t One or more patient types are no longer part of the population

t Possible seasonal change of the patient population (hospitals or clinics in resort

r If a change in the overall patient population is probable,

t Future XB batch results will also be outside the limits

t New target values based on the current population must be established and entered

r If a change in the overall patient population is not probable,

t It is possible that the patient population has not really changed but just appears to

t Use the

areas)

in the computer

have changed because the batch of 20 patients does not truly represent the total
population

Current XB Batch option to check for non-reportable results and/or

non-random sampling:

Sample Analysis tt XB tt Current XB Batch

Checking for Non-Reportable Results

r An XB batch may go outside the ±3% action limits because the batch is biased by

physiologically impossible results caused by a reagent or instrument problem, or by
physiologically abnormal specimen

Consider an Instrument Problem Exists

r Consider an instrument problem only if

t A change in the patient population is doubtful

t All the results in the Current XB Batch are reportable (physiologically possible)

t Random sampling is verified

r Instrument problems cause XB batch results to go “out” and stay out

t Can be a gradual change

t If caused by a calibration drift, should go back within limits after calibration

t If caused by a component going bad over time, should go back within limits

after the component is replaced

t Can be a sudden change

t If caused by a component failure, should go back within limits after the

component is replaced

t If caused by any number of instrument problems, should go back within limits

after the problem is fixed

4-30

PN 4237530BB

QUALITY CONTROL

ADDITIONAL QC CHECKS

Assessing the Situation

r Review the XB Graphs and XB Batch Means options to identify the out-of-limits RBC

indices and note the direction of the change (increased or decreased)

t Generally two of the three RBC indices are affected

t It is also important to note any index that may still be inside the limit but shows a

significant change

Identifying the Parameter Causing the Problem

r There are two ways to identify the parameter causing the problem

t Knowledge and analysis of the involved parameters

t Use of a table showing the relationship between the RBC Indices and their

associated parameters

Analysis of Involved Parameters

r MCV parameter is derived from the RBC Histogram

t Although derived from the histogram, the size of the individual red cells is

determined using the Coulter Principle which is a direct measurement

4

Hgb

r

r

MCH

MCHC

-----------­RBC

Hgb

---------­Hct

10×=

100×=where the Hct

RBC MCV×

-------------------------- -----=
10

r RBC indices are based on three directly measured parameters: MCV, RBC, and Hgb

By Use of a Parameter Relationship Table

r Table relates the RBC Indices and their associated parameters

MCV

LOW

MCV dec inc --- --- inc dec

RBC --- --- inc dec inc dec

Hgb --- --- dec inc dec inc

Hct dec inc --- --- inc dec

MCV

HIGH

MCH
LOW

MCH

HIGH

MCHC

LOW

MCHC

HIGH

r Once the operator identifies the affected RBC indices and notes the direction of the

change (increased or decreased), the table reveals the suspected parameters (MCV, RBC,
or Hgb)

PN 4237530BB

4-31

QUALITY CONTROL

ADDITIONAL QC CHECKS

NOTES

4-32

PN 4237530BB

OBJECTIVES

When the subject is complete, you will be able to . . .

r Explain the purpose of calibration.

r Tell when one needs to verify calibration.

r Perform the preliminary procedures.

r Perform the calibration procedure using the Special Procedures and Troubleshooting

(SPT) Manual.

CALIBRATION

5

5

PN 4237530BB

5-1

CALIBRATION

OBJECTIVES

NOTES

5-2

PN 4237530BB

CALIBRATION

r A procedure used to standardize the instrument by determining its deviation from

r Never use calibration to adjust for an instrument problem

r Verify the ambient room temperature is typical for the laboratory and within the

r In the normal process of tracking data for an extended period of time, your laboratory

r Never adjust to a specific value based on an individual sample result

When to Calibrate

r At installation, before you begin analyzing samples

r After you replace any component dealing with

r If your Beckman Coulter Representative suggests you calibrate

calibration references and applying any necessary correction factors

instrument’s operating range (16 to 32°C; 60 to 90°F)

can make a specific decision to recalibrate a given parameter

t Dilution preparation, such as the BSV
t Primary measurement, such as an aperture

CALIBRATION

CALIBRATION

5

When to Verify Calibration

r As dictated by your laboratory procedures, local, or national regulations

r When controls show evidence of unusual trends

r When controls exceed the manufacturer’s defined acceptable limits

r When average ambient room temperature changes more than 10°F (5.5°C) from the

room temperature during your last calibration

PRELIMINARY CALIBRATION PROCEDURES

r Procedures designed to ensure the instrument is operating optimally

r Recommend a thorough review of data stored in current control and X

possible bias that might require a change in a calibration factor

r Thorough review of IQAP data is also recommended

files to note any

B

PN 4237530BB

5-3

CALIBRATION

CALIBRATION PROCEDURE

Procedures to be Completed Prior to Calibration

r Check reagent volumes to ensure sufficient volume to complete calibration procedures

r Ensure the instrument is clean

t If the instrument is routinely shut down with COULTER CLENZ cleaning agent for

at least 30 minutes every 24 hours it is in use, initiate the

t If the instrument is not routinely shut down with COULTER CLENZ cleaning agent

for at least 30 minutes every 24 hours the instrument is in use, the apertures must
be bleached as instructed in the SPT’s Cleaning Procedures chapter

r Bleach the aspiration system using the

Special Functions tt Diagnostics tt Operator Options tt Fluidic Tests tt Clean Needle

r Do a Start Up

r Run commercial cell controls

CALIBRATION PROCEDURE

r Beckman Coulter recommends using S-CAL Calibrator and performing the procedure in

the Primary mode (Closed-Vial mode)

Clean Cycle option

Clean Needle option

r Carefully follow the instructions in Chapter 1 of the Special Procedures and

Troubleshooting (SPT) Manual anytime calibration is performed

r From the Main Menu, selecting

Special Functions tt Calibration tt CBC Calibration accesses

the CBC Calibration screen

CBC Calibration Screen

5-4

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CALIBRATION PROCEDURE

Terms and Formulas used in the CBC Calibration Procedure

MEAN

r Average of the 10 S-CAL calibrator runs

t Run 1 of the 11 runs is automatically deleted

NEW CAL FACTOR

r Calibration Factor needed to recover the S-CAL Calibrator Reference value

r It is calculated and displayed regardless of whether or not you need to change it

CALIBRATION

5

NEW CAL FAC

OLD CAL FACTOR

r The current Calibration Factor in use by the analyzer

% CV

r Indicates the reproducibility of the S-CAL Calibrator run

r Checked to ensure valid data is used as you are deciding whether or not to recalibrate

FACTOR % DIFF

r The percentage difference between the NEW CAL FAC and the OLD CAL FAC

DELTA DIFF

r Absolute difference between the REFERENCE VALUE and the S-CAL Calibrator MEAN

REFERENCE VALUES

r The assigned value for each parameter

Reference Value Old Cal Factor×

--------------------------- --------------------------------- ----------------------=
S-CAL Mean Value (n=10)

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5-5

CALIBRATION

CALIBRATION PROCEDURE

5-6

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OBJECTIVES

When the subject is complete, you will be able to . . .

Basics of Running a Sample

r State the proper anticoagulant to use for specimens processed on a HmX Hematology

r State the minimum volume of blood needed for the Primary mode, Secondary mode,

r State the maximum storage time prior to running a specimen for CBC, Differential, and

r State the proper storage temperature.

r Properly place a bar-code label on a specimen tube.

r Properly insert a bar-code labeled specimen tube into a cassette or the cap-pierce station,

r Explain the purpose of a Worklist.

r Explain the purpose of the blood detecting system.

Analyzer with Autoloader or HmX Hematology Analyzer.

Predilute mode, and Retic mode.

Retic analysis.

as applicable.

SAMPLE ANALYSIS

6

6

Cycling Options

r Use the correct F3-Run option to designate the appropriate operation mode for the

required task.

r Identify when it is necessary to use

r Set up the options you want under

r Explain the purpose of the

r Print results automatically.

r Explain how an operator can quickly verify the communication link between the DMS

and HmX instrument is intact.

Running Whole Blood Patient Samples

r Run samples in the Primary mode.

r Briefly describe the cassette transport or rotary cap-piercing operational sequence,

as applicable.

r Run samples in the Secondary mode.

r Run samples with and without differentials.

Processing a STAT Specimen (HmX Hematology Analyzer with Autoloader only)

r Interrupt Primary mode operation to run a STAT specimen.

r Resume operation in the Primary mode without skipping any patient samples.

F7-Display Only option.

F9-STOP prior to changing the instrument’s state.

F5-Optns.

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Predilute Mode

r State when this mode should be used.

r State the dilution ratio required for processing samples.

6-1

SAMPLE ANALYSIS

OBJECTIVES

Run Samples Screen

r Explain É through Í and Ñ on the Run Samples screen.

r Name and define each area on the Run Samples screen.

r Label the WBC populations on a normal DF1 scatterplot.
r Use Ó to display Suspect and Definitive flag messages.

Retic Mode

r State the volumes used in the reticulocyte procedure for:

r State the minimum and maximum incubation times for the blood/stain mixture.

r State the waiting time once Reagent B is added to the proper volume of the incubated

t Whole blood

t Reagent A

t Incubated blood/stain mixture for the final preparation

t Reagent B

blood/stain mixture.

Worklist (Optional)

r Define the PART ASP, NO MATCH, and NO READ error messages.

r List indications the system gives when

t Three consecutive PART A S P, NO MATCH, or NO READ errors occur.

t Any combination of 10 errors accumulate on the Worklist.

r List the steps an operator must take to resume operation when the above errors occur.

r Explain what the colors behind the

r Explain what the

↑ or ↓ next to WL on the Status line indicates.

WL on the Status line indicate.

6-2

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SAMPLE HANDLING

Specimen Collection

Using Evacuated Collection Tubes

r Collect venous blood specimens in K

t A proper proportion of whole blood to anticoagulant is critical

t K

validation studies are based on its use

t K

by instruments using VCS technology

r Specimen tubes cycled in the Primary mode must contain a minimum 1.0 mL of a

properly collected specimen

Using Microcollection Devices

r Anticoagulated capillary specimens collected in a microcollection device may be directly

aspirated into the HmX instrument using the Secondary mode

r Proper collection is critical to avoid micro-clots and/or debris

SAMPLE ANALYSIS

SAMPLE HANDLING

EDTA or K2EDTA

3

EDTA is the preferred anticoagulant because all performance claims and

3

EDTA shows no significant differences for CBC and differential results generated

2

6

r Review and follow the directions in the package insert provided by the manufacturer

Storage

r Run a CBC/Diff specimen within 24 hours of collection

r Store specimens capped at room temperature

r Run a Retic specimen within 8 hours of collection if stored at room temperature or

within 24 hours if refrigerated (2-8°C; 36-46°C)

BAR-CODE LABELING

IMPORTANT Risk of misidentification. Do not use the tilde (~) character in demographics, including

Specimen or Patient ID.

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6-3

SAMPLE ANALYSIS

BAR-CODE LABELING

Correct Incorrect

Stopper

Bars parallel
to stopper

Incorrect

Label covers
the bottom
end of the tube

Bars not
parallel
to stopper

Proper Placement of a Bar-Code Label on a Specimen Tube

r Bar-code labels must be within specifications as stated in the Reference Manual

r The bars on the label must be parallel to the stopper

t If the label is skewed more than 5 degrees, the scanner may not read it

r Do not cover the bottom of the tube with the bar-code label

t On a HmX Hematology Analyzer with Autoloader, this space is needed for the

scanner to distinguish the specimen tube label from the cassette label

t On a HmX Hematology Analyzer with rotary cap-pierce, proper label placement

prevents jamming in the carousel

Tube Adapters for Single Specimen, Rotary Cap-Pierce Instruments Only

r Tube adapters are used for 2 mL and 3 mL specimen tubes

t 2 mL adapter is for 10.25 mm x 47 mm specimen tubes

t 3 mL adapter is for 10.25 mm x 64 mm specimen tubes

t Although they appear similar, the base differs to provide different stop points for the

specimen tubes

r An operator may scan the bar-code labeled specimen tube before or after placing the tube

into the adapter

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CYCLING OPTIONS

F3-Run Options

From the Main Menu, select Sample Analysis tt Run Samples tt F3-Run

Ê START PRIMARY

r Closed-Vial mode

Ë

SECONDARY

r Open-Vial mode

Ì

PREDILUTE CBC

r Open-Vial mode only

r For processing a 1:3 sample dilution (1 part blood to 2 parts diluent) in the

RETIC

Í

r Open-Vial mode only

r Sample preparation is required before processing in the Secondary mode

Secondary mode

SAMPLE ANALYSIS

CYCLING OPTIONS

6

Î

DIFF ON / OFF

r To toggle this option ON or OFF, the SAMPLE MODE ? prompt must appear at the

top of the

r If the SAMPLE MODE ? prompt is not displayed, press Ñ

Note: If an operator attempts to change the DIFF status without pressing Ñ
the DMS beeps and will not make the requested change.

PURGE

Ï

r For troubleshooting purposes

Ð

RINSE

r For troubleshooting purposes

Ñ

STOP

r Stops the system as soon as the current cycle is complete

r Returns the system to SELECT FUNCTION

r Must be used when changing the DIFF mode from ON to OFF
r If an operator attempts to change the DIFF mode without using Ñ

instrument signals with an audible beep

F3-Run window

STOP

STOP first, the

STOP,

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6-5

SAMPLE ANALYSIS

CYCLING OPTIONS

F5-Optns

From the Main Menu, select Sample Analysis tt Run Samples tt F5-Optns

Ê XB

r Three indicators:

t ON / OFF current usage of X

Analysis

B

t N number of patient samples accumulated in the current batch

t IN / OUT status of the last completed batch of 20 patient samples

r If

Display Only is ON, then XB is automatically turned OFF

r If instrument is reset, ON is the default setting

Ë CAP PIERCER: 10mm-13mm (Single Specimen, Rotary Cap-Pierce System Only)

r Allows the operator to select the correct size carousel slot based on the size of the

specimen tube

t Majority of the tubes are 10-13 mm tubes (Control tubes are 10-13 mm)

t 16 mm tubes are the fat 7 mL specimen tubes

r Do not run 10-13 mm tubes in the 16 mm tube slot

r Run control and calibrator vials in the 10-13 mm slot

r If instrument is reset, 10 mm - 13 mm is the default setting

Ì DB

r Must be on to store patient results

r Data base can store up to 5000 complete sets of results including retic results

r When the data base is full, the newest sample results replace the oldest sample

results in a process referred to as wraparound

r If

Display Only is ON, then the data base is automatically turned OFF

r If instrument is reset, ON is the default setting

6-6

Í Print

r If the setting is NONE, the operator must manually print results from display screen

or data base

r If the setting is ALL, NORMAL, or ABNORMAL, results are automatically printed as

they are run

t Results are considered abnormal when any of the parameter codes or messages

listed in Chapter 4 of the Operator’s Guide are generated

r If instrument is reset, NONE is the default setting

Î Host

r Turn this on if your laboratory is interfaced to a host computer and you want the

results to transmit automatically to the host as the samples are run

r If

Display Only is ON, then the host is automatically turned OFF

r If instrument is reset, OFF is the default setting

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SAMPLE ANALYSIS

CYCLING OPTIONS

Ï Display Only

r Useful for cycling samples when an operator does not want results sent to the host

computer or stored in XB or the data base

t Especially helpful when troubleshooting

r Quick way to turn XB, DB, and Host off then back on simultaneously

t Position of the arrows on the Status line easily verifies the current state of these

options

r If instrument is reset, OFF is the default setting

Ð Operator

r Operator identification

r Up to three alphanumeric characters can be entered

r If instrument is reset, OPR is the default setting

Ó B&W screen print

r Used to make a large black and white printout of the results displayed on the screen

r Can only be used for the current sample

6

Ô Color screen print

r Used to make a large color printout of the results displayed on the screen if a color

ribbon or ink cartridge is installed

r Can only be used for the current sample

Note: When at the Main Menu, an operator can access a window displaying the

F6-Host, and Operator options by pressing Í Options.

To continue HmX Hematology Analyzer training, proceed to page 6-9.

To continue HmX Hematology Analyzer with Autoloader training, go to page 6-15.

F5 -Print ,

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6-7

SAMPLE ANALYSIS

CYCLING OPTIONS

NOTES

6-8

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