Beckman Coulter COULTER ACT 5diff Guida all'installazione

COULTER AC•T 5diff Autoloader

Hematology Analyzer

Operator’s

Training Guide

PN 177196BB (August 2012)

Manufactured for

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea, CA 92821 U.S.A.

WARNINGS AND PRECAUTIONS

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.

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.

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.

iii

PN 177196BB

REVISION STATUS

Issue A, 10/02

Software version 1.00

Issue B, 4/03

Software version 1.10

Issue BA, 5/10

Software Version 1.10.

Updates were made to the company corporate address.

Issue BB, 08/12

Software Version 1.2.4.

Changes were made to:

r Section 1.5, ANALYZER > D Topic Notes and Tasks, step 3a2

r Removed step 5c under SHUTDOWN PROCEDURE > D Topic Notes and Tasks

r Carryover Check

r Refer to the Hematology Tube List on the BCI website

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

margin of the amended page.

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.

PN 177196BB

REVISION STATUS

PN 177196BB v

CONTENTS

WARNINGS AND PRECAUTIONS,ii

REVISION STATUS, iii

CONTENTS,v

INTRODUCTION,ix

PURPOSE OF THIS DOCUMENT,ix

TRAINING RESPONSIBILITIES,ix

INSTRUMENT DOCUMENTATION,ix

ABOUT THIS TRAINING GUIDE,x

CONVENTIONS,xi

SAFETY SYMBOLS,xii

1 GETTING TO KNOW YOUR INSTRUMENT,1-1

1.1 WORKSTATION HARDWARE,1-1

1.2 WORKSTATION SOFTWARE AND THE ONLINE HELP SYSTEM,1-4

1.3 PRINTER,1-9

1.4 BAR-CODE SCANNER (OPTIONAL),1-10

1.5 ANALYZER,1-11

1.6 REAGENTS AND INSTRUMENT WASTE,1-17

2 STARTUP / SHUTDOWN,2-1

2.1 STARTUP PROCEDURE,2-1

2.2 MINI-CLEAN CYCLE,2-4

2.3 AUTO-CLEAN CYCLE,2-5

2.4 SHUTDOWN PROCEDURE,2-6

2.5 SYSTEM POWER DOWN PROCEDURE,2-7

2.6 SYSTEM POWER UP PROCEDURE,2-8

3 SETUP OPTIONS,3-1

3.1 MISCELLANEOUS (OPERATIONAL) SETUP OPTIONS,3-1

3.2 QUALITY ASSURANCE SETUP OPTIONS,3-5

3.3 AUTO FUNCTIONS SETUP OPTIONS,3-7

PN 177196BB

CONTENTS

3.4 SYSTEM SETUP OPTIONS,3-9

3.5 CONFIGURATION SAVE AND RESTORE SETUP OPTIONS,3-13

3.6 OPERATORS SETUP OPTIONS,3-14

3.7 FLAGGING SETS SETUP OPTIONS,3-16

4 QUALITY ASSURANCE,4-1

4.1 SETTING UP OR MODIFYING CELL CONTROL FILES,4-1

4.2 ANALYZING CELL CONTROLS,4-3

4.3 INTERPRETING AND USING CELL CONTROL DATA,4-9

4.4 CONTROL DATA MANAGEMENT,4-13

4.5 INTERLABORATORY QUALITY ASSURANCE (IQAP),4-14

4.6 REPRODUCIBILITY AND CARRYOVER CHECKS,4-15

4.7 SETTING UP XB/XM,4-17

4.8 INTERPRETING AND USING THE XB/XM DATA,4-20

5 CALIBRATION,5-1

5.1 CALIBRATION OVERVIEW,5-1

5.2 PRELIMINARY CALIBRATION CHECKS/PROCEDURES,5-2

5.3 AUTO-CALIBRATION,5-3

5.4 MANUAL CALIBRATION,5-7

6 SAMPLE ANALYSIS,6-1

6.1 SPECIMEN HANDLING,6-1

6.2 SAMPLE IDENTIFICATION,6-3

6.3 PATIENT/SAMPLE INFORMATION,6-6

6.4 WORKFLOW OPTIONS,6-12

6.5 SAMPLE ANALYSIS IN THE AUTOLOADER MODE,6-14

6.6 SAMPLE ANALYSIS IN THE MANUAL MODE,6-16

6.7 RUN-IN-PROGRESS, RESULTS LIST, AND RESULTS SCREENS,6-18

6.8 AUTOMATIC AND MANUAL SPECIMEN RERUNS,6-23

6.9 MANUAL MATCHES,6-24

PN 177196BB vii

CONTENTS

7 DATA MANAGEMENT AND REVIEW,7-1

7.1 DATA MANAGEMENT,7-1

7.2 DATA ANALYSIS - AN OVERVIEW OF THE DILUTIONS AND

MEASUREMENTS,7-3

7.3 DATA ANALYSIS - MEASUREMENT PRINCIPLES,7-9

7.4 DATA ANALYSIS REVIEW - WBC PARAMETERS,7-15

7.5 DATA ANALYSIS REVIEW - RBC PARAMETERS,7-21

7.6 DATA ANALYSIS REVIEW - PLATELET PARAMETERS,7-27

8 SYSTEM DIAGNOSTICS AND MAINTENANCE,8-1

8.1 ACCESSING AND IDENTIFYING ANALYZER HARDWARE COMPONENTS,8-1

8.2 RECOGNIZING NORMAL INSTRUMENT OPERATION - CYCLE

DESCRIPTION,8-7

8.3 BASIC TROUBLESHOOTING TECHNIQUES,8-16

8.4 SYSTEM MESSAGE TABLES AND OTHER TROUBLESHOOTING TOOLS,8-19

8.5 PREVENTIVE MAINTENANCE,8-22

9 SUMMARY AND QUICK REFERENCE MASTERS,9-1

9.1 SUMMARY PAGES,9-1

9.2 QUICK REFERENCES PAGES,9-1

9.3 CONTENTS,9-1

TRAINING CHECKLIST,1

ACCOUNT INFORMATION,1

PURPOSE,1

INSTRUCTIONS,1

CHECKLIST,1

TRADEMARKS,1

PN 177196BB

viii

CONTENTS

PN 177196BB ix

INTRODUCTION

PURPOSE OF THIS DOCUMENT

This document provides an authorized trainer with corporately accepted training materials

for instructing a new Operator in the correct use and operation of a COULTER AC•T 5diff

Autoloader (AL) hematology analyzer.

TRAINING RESPONSIBILITIES

Beckman Coulter’s Responsibility

Beckman Coulter is responsible for instructing a Key Operator in the correct use and

operation of the AC•T 5diff AL 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 in this Training Guide 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 the laboratory. Once

trained by an authorized Beckman Coulter trainer, the Key Operator is authorized to use and

make copies of any of the material in this Training Guide as needed for training other

laboratory personnel.

INSTRUMENT DOCUMENTATION

The Training Guide is part of a document set provided with your instrument. The Training

Guide references the following documents whenever appropriate, to help the trainee become

familiar with their contents and to use them as needed.

r Instructions for Use, PN 4277367, provides information about the function of the AC•T

5diff AL instrument and describes how to:

t Get started using the instrument.

t Operate the instrument safely.

t Run controls and samples.

t Review results.

t Do special maintenance procedures, such as cleaning, replacing, or adjusting an

instrument component.

t Troubleshoot problems.

t Power down and power up the instrument.

t Customize the instrument’s setup.

The Instructions for Use is accessed using the AC•T 5diff AL Online Help system. The

printed version is by order. Contact your Beckman Coulter Representative if you want to

order a printed copy of this manual.

PN 177196BB

INTRODUCTION

ABOUT THIS TRAINING GUIDE

r Host Transmission Specification, PN 4277065, defines the information needed to

program the transmission interface between the AC•T 5diff AL hematology analyzer and

your laboratory’s host computer. The printed version is available by order. Contact your

Beckman Coulter Representative if you want to order a printed copy of this manual.

ABOUT THIS TRAINING GUIDE

Scope

This training guide is designed to support AC•T 5diff AL hematology analyzer training. It

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.

Topics

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

r Topic 1 Getting to Know Your Instrument

r Topic 2 Startup/Shutdown

r Topic 3 Set Up Options

r Topic 4 Quality Assurance

r Topic 5 Calibration

r Topic 6 Sample Analysis

r Topic 7 Data Management and Review

r Topic 8 System Diagnostics and Maintenance

Each main topic is further divided into several related topics (subjects) that may be included,

as needed, in your training. Each of these smaller topics includes four elements:

A Objectives. Lists the objectives the trainee is expected to meet at the completion of the topic.

B References. Lists the sections in the customer documentation where the topic is covered.

These references can be used by the trainer to prepare for teaching the topic and could be

assigned to the trainee as prerequisite or review reading.

C Special Instructions. Lists the instrument conditions that must be met, supplies needed

(when applicable), and other tips to the trainer for completing the topic.

D Topic Notes and Tasks. Lists the key facts that should be covered and suggests tasks to

promote or reinforce learning the topic material.

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