Beckman Coulter 773022BE University Physics Volume 1

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COULTER LH 780 System

Instructions for Use

III

VII

VIII

ALARM

PREMIX

START

STOP

PRIME

CLEAR

DRAIN

RINSE

RESET

APERT

CONT

APERT

POWER ON

START UP

POWER OFF

SHUT DOWN

NEC

MultiSync LCD 1700m+

PN 773022BE (January 2013)

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

WARNINGS AND PRECAUTIONS

READ ALL PRODUCT MANUALS AND CONSUL T WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMP T ING 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

Issue A, 12/06 Software version 1A. Manual derived from Help version 1A.063001.

Issue B, 10/07 Software version 1B. Manual derived from Help version 1B.072681.

Issue BA, 08/09 Software version 1B1. Manual derived from Help version 1B1.091732.

Issue BB, 10/10 Software version 1B1.

Updates were made to the Company corporate address. Issue BC, 12/10

Software version 1B1. Changes were made to:

r Bar-code ID Field r Manually Setting Up Controls in Units Other Than US1 or US2 r STORING SPECIMENS r USING HANDHELD SCANNER

Issue BD, 12/11 Software version 1B1.

Changes were made to:

r Tube Sizes r Universal Tube Processing

Issue BE, 01/13 Software version 1B3. Manual derived from Online Help 1B3.

Changes were made to:

r Universal Tube Processing r Removable Media Entry Window r SETTING UP LIS / HIS COMMUNICATIONS r LIS COM Port Configuration r INTERUNIT CONNECTIONS

PN 773022BE

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

PN 773022BE

WARNINGS AND PRECAUTIONS,ii REVISION STATUS, iii CONTENTS,v INTRODUCTION, xiii

HOW TO USE YOUR COULTER LH 780 SYSTEM HARD-COPY MANUALS, xiii ABOUT THIS MANUAL,xiv ONLINE HELP SYSTEM,xiv CONVENTIONS,xiv

1 CONTROLS AND INDICATORS,1-1

1.1 ANALYZER,1-1 Analyzer Screen and CRT Buttons,1-1

1.2 DILUTER,1-2 Numeric Keypad,1-2 Numeric Keypad--.,1-3 Numeric Keypad--0-9,1-3 Numeric Keypad--Alarm Reset,1-3 Numeric Keypad--CE,1-4 Numeric Keypad--CLEAR APERT,1-4 Numeric Keypad--DRAIN,1-5 Numeric Keypad--ENTER,1-5 Numeric Keypad--F,1-6 Numeric Keypad--ID,1-6 Numeric Keypad--POWER OFF,1-6 Numeric Keypad--POWER ON,1-7 Numeric Keypad--PREMIX,1-7 Numeric Keypad--PRIME APERT,1-8 Numeric Keypad--RINSE,1-8 Numeric Keypad--SHUT DOWN,1-9 Numeric Keypad--START UP,1-9 Numeric Keypad--START/CONT,1-10 Numeric Keypad--STOP,1-11

1.3 POWER SUPPLY,1-12 Side/Front,1-12 Back,1-13 Power Supply Function Levels,1-13 Power Supply Function Status,1-14 Power Supply Adjustment Controls,1-14

1.4 WORKSTATION,1-16 CD ROM Drive,1-16

3.5-inch Diskette Drive,1-16

PN 773022BE

CONTENTS

Power On/Off (Workstation),1-17 Workstation Keyboard,1-17 Monitor and Volume Controls,1-18 Using Command Center,1-18 Process Type,1-19 Bar-code ID Field,1-19 Status Area,1-20 Default Type,1-21 Last Message,1-21 Reviewing System Status,1-21

2STARTUP,2-1

2.1 LOGGING OFF/ON THE WORKSTATION,2-1 Logging OFF,2-1 Logging ON,2-1

2.2 PERFORMING DAILY STARTUP,2-1 Checking Instrument Operation,2-1 Setting Up Analyzer Date and Time,2-2 Setting Up Analyzer Date Format,2-2 Turn Pneumatics ON,2-2 Checking Power Supply and Vacuum Level,2-3 Check Baths,2-3 Automatic Startup Cycles,2-4 Checking Daily Test Results,2-4 Checking Background Test Results,2-4 Checking HGB Voltage Test Results,2-5 Checking Instrument Setup,2-5 Checking Precision Test Results,2-5 Checking Ramp Test Results,2-6 Possible Startup Problems and Fixes,2-6 Running Controls,2-6

3 QUALITY CONTROL,3-1

3.1 QUALITY CONTROL OVERVIEW,3-1

3.2 LATRON,3-1 Running Latex Control—Diff,3-1 Running Latex Control—Retic,3-3 Running Latex Control—Diff and Retic ,3-4

3.3 5C SERIES CELL CONTROL AND RETIC-C,3-5 Cycling Controls,3-5 Aspirate Control in Manual Mode,3-6 Reviewing Control Results,3-7 Control Codes and Flags,3-7 When a Control is Outside Its Expected Ranges,3-8 When a Latex Control is Outside its Expected Ranges,3-9 Controls Window,3-9

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Transmit, Print and Archive,3-10 Deleting Control Data,3-10 Adjusting Control Limits,3-11 Providing Comments for Quality Assurance,3-11 Performing NRBC Quality Control,3-11

3.4 EXTENDED QC,3-13 Overview,3-13 Extended QC - Random Error,3-14 Extended QC- Systematic Error,3-14 Extended QC- Total Error,3-15

3.5 XB ANALYSIS,3-16 Overview,3-16 Reviewing XB Results,3-16 Adding Comments to an XB Batch,3-17

3.6 Xm Analysis Overview,3-17 Overview,3-17 Reporting,3-20 Reviewing XM Results,3-20 Adding Comments to an Xm Batch,3-21

CONTENTS

3.7 PARTICIPATING IN IQAP,3-21 IQAP Setup,3-21 IQAP Download Procedure,3-21 Troubleshooting,3-22

3.8 PARTICIPATING IN eIQAP,3-22 Enroll in eIQAP,3-22 Data Submission for eIQAP,3-22

4RUN SAMPLES,4-1

4.1 COLLECTING WHOLE BLOOD SPECIMENS,4-1

4.2 STORING SPECIMENS,4-1 Venipuncture Specimens,4-1

4.3 IDENTIFYING SAMPLES OVER VIEW,4-2 Automatic Aspiration Mode,4-2 Manual Aspiration Mode,4-2 Using the Predilute Mode,4-2 Setting Up Identifiers,4-3 Tube Sizes,4-3 Universal Tube Processing,4-4

4.4 USING BAR-CODE LABELS,4-5 Labeling Requirements—Tubes Without Adapters or Clips,4-5 Labeling Requirements—Tubes with Sleeve Adapters,4-6 Labeling Requirements—Tubes with Cassette Clips,4-7

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vii

CONTENTS

4.5 CASSETTE HANDLING ,4-8 Cleaning the Cassette,4-8

4.6 LOADING THE CASSETTE,4-9 Using Cassette Clips,4-9 Installing the Cassette Clips,4-10

4.7 USING HANDHELD SCANNER,4-11 Setting Up Bar-Code Configuration,4-12

4.8 CYCLING SAMPLES IN AUTOMATIC ASPIRATION MODE,4-13

4.9 CYCLING SAMPLES IN MANUAL ASPIRATION MODE,4-13

4.10 CHANGING THE NUMBER OF ASPIRATIONS PER TUBE,4-15

4.11 CHANGING TEST MODE,4-15

4.12 ENABLING/DISABLING BLOOD DETECTOR,4-16

5 REVIEWING DATA,5-1

5.1 REVIEWING SAMPLE RESULTS,5-1

5.2 Results & Graphics Overview Tab,5-1

5.3 REVIEWING 2D DATAPLOTS,5-3 Enlarged View,5-3 What to Look For ,5-3

5.4 REVIEWING 3D DATAPLOT,5-4 Retrieving Data,5-5 Changing the Perspective,5-5 Minimizing the Window,5-5

5.5 REVIEWING HISTOGRAMS,5-5 What to Look For ,5-6

5.6 EDITING SAMPLE RESULTS,5-6

5.7 REVIEWING PATIENT HISTORY,5-7

5.8 PROCESSING RESULTS OVERVIEW,5-7 Flagging,5-7 Rules for Flagging Results (Decision Rules & Criteria),5-8 Processing Flagging Limits,5-8

5.9 FLAGS,5-9

5.10 CODES,5-11

5.11 SUSPECT MESSAGES,5-12 Optimizing Efficiency,5-12

viii

PN 773022BE

5.12 DEFINITIVE MESSAGES,5-14 Definitive Messages,5-14 Auto Validation Overview,5-15

6SHUTDOWN,6-1

6.1 POWER ON/OFF OVERVIEW,6-1 Workstation,6-1 Analyzer/Diluter,6-1 Power Supply,6-2

6.2 PERFORMING DAILY SHUTDOWN,6-2

6.3 PERFORMING EXTENDED SHUTDOWN AND RESTART,6-2 Shutdown,6-2 Restart,6-2

6.4 SHUTTING DOWN THE WORKSTATION,6-3

6.5 RESETTING THE WORKSTATION,6-4 Using the Command Center,6-4 Using the Keyboard,6-4

CONTENTS

7 DATABASE AND TODO LIST,7-1

7.1 DATABASE & TODO WINDOW,7-1 Columns You May Not Understand,7-1 Finding and Sorting,7-1 Selecting,7-1 Transmitting, Printing and Archiving,7-2 Other Actions,7-2

7.2 COMMON FUNCTIONS (OVERVIEW),7-2 Transmitting Results,7-2 Printing Reports,7-2 Archiving Data,7-3 Deleting Data,7-3 Deleting Patient Data,7-3 Deleting Sample Information,7-3 Printing,7-4 What Prints When You Select ,7-4 Archiving,7-6 Formatting a CD for Direct Archiving,7-6 Archiving to a CD,7-6 Reviewing Archived Information,7-7

7.3 SAVING SAMPLE RESULTS,7-8

7.4 ADDING A SAMPLE REQUEST TO THE TODO LIST,7-9 Adding a Test to an Existing Set of Sample Results,7-9

7.5 DATABASE OVERVIEW,7-10

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CONTENTS

How Overwriting and DataBase Storage Work for Sample Results,7-10 DataBase Storage Limits and Saving Results,7-10

7.6 TODO LIST OVERVIEW,7-10 Setting Up AutoSequencing,7-11

7.7 RANDOM ACCESS OVERVIEW,7-12 Random Access,7-12

7.8 COLLATION OVERVIEW,7-13 How Collation Works,7-13 Printing Collated Reports,7-13

7.9 SEARCHING FOR RESULTS OVERVIEW,7-14 Searching,7-14 Results of a Search,7-14 Search Criteria,7-14

7.10 FINDING SAMPLE RESULTS USING THE DATABASE EXPLORER BUTTON,7-14 Using a Search Criteria Name,7-15 Saving Search Criteria,7-15

7.11 VIEWING DATABASE COUNT INFORMATION,7-16

8SETUP,8-1

8.1 SYSTEM SETUP OVERVIEW,8-1

8.2 CHANGING REAGENT INFORMATION,8-2

8.3 SETTING UP CONTROLS ,8-3 Removable Media Entry Window,8-4 Specifying Latex Reference Values,8-4 Specifying Reference Values,8-5 Deleting Control Setup Information,8-5 Editing Control Setup Information,8-6 Setting Up Lab Limits for Controls,8-7

8.4 Enabling Extended QC,8-7

8.5 SETTING UP XB ANALYSIS,8-8

8.6 Setting Up Xm Analysis,8-8

8.7 SETTING UP SHIFTS FOR CONTROLS,8-9

8.8 SETTING UP DISPLAY LABELS FOR REPORTING,8-10

8.9 SETTING UP A POSITIVE IDENTIFIER,8-10

8.10 SETTING UP AUTOSEQUENCING,8-11

8.11 SETTING UP THE RBC HISTOGRAM NORMAL RANGE,8-11

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8.12 SPECIFYING THE PARAMETERS YOU WANT TO REPORT,8-12

8.13 SETTING UP REPORTING UNITS,8-12 Manually Setting Up Controls in Units Other Than US1 or US2,8-13

8.14 SETTING UP FLAGGING LIMITS,8-14 Flagging Preferences,8-16 Defining Definitive Messages,8-17 Editing Existing Flagging Limits,8-17

8.15 SETTING UP RULES FOR FLAGGING SAMPLE RESULTS ,8-18 Defining Delta Check Criteria,8-19 Defining Reflex Manager Criteria,8-20 Setting Up the Rule Environment,8-20

8.16 Setting Up the RBC Histogram Normal Range,8-21

8.17 SETTING UP REPORTS,8-21 Show Last Name Before First Name,8-22

CONTENTS

8.18 SETTING UP INSTITUTION DETAILS,8-22

8.19 SETTING UP LIS / HIS COMMUNICATIONS,8-23 LIS COM Port Configuration,8-25

8.20 INTERUNIT CONNECTIONS,8-27 Power and Signal Cables,8-27 Changing 9-pin and 25-pin connectors,8-28 Setting Up Auto Validation,8-28 Sending LH 780 Data,8-30

8.21 CHANGING AN INSTRUMENT NAME,8-31

8.22 REVIEWING WORKST ATION SETTINGS,8-31

8.23 SETTING UP USER ACCESS LEVELS,8-32 Changing Your Password,8-32

8.24 CHANGING PHYSICIAN LIST,8-33 Adding to the List,8-33 Editing the List,8-34 Deleting from the List,8-34

8.25 CHANGING LOCATION LIST,8-35 Adding to the List,8-35 Editing the List,8-35 Deleting from the List,8-35

8.26 SETTING UP DATABASE STORAGE LIMITS,8-36 Setting Up Screen Saver,8-36 Setting Up Colors,8-37 Setting Up Date and Time,8-37 Setting Up Your Default Printer,8-38

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CONTENTS

Setting Up a New Printer,8-38

8.27 RUN CONFIGURATION WINDOW,8-39 Changing Your Default Printout Format,8-40 Changing Your Default Report Layout,8-40 Setting Up Which Results to Print Automatically,8-40 Setting Up Which Results to Transmit Automatically,8-41 Turning AutoStop OFF/ON ,8-41 Turning SlideMaker OFF/ON ,8-41 Setting Up When to Make a Slide,8-42 Turning Decision Criteria OFF/ON,8-42 Turning AutoNumbering OFF/ON,8-42 Turning AutoCollation OFF/ON,8-42 Turning XB Analysis OFF/ON,8-43 Turning Xm Analysis OFF/ON,8-43 Specifying Default Control Lot Numbers,8-44 Change the Control Lot Status,8-44 Changing the Active Printer,8-44

INDEX,INDEX-1 REFERENCES, REFERENCES-1 TRADEMARKS, TRADEMARKS-3

xii

PN 773022BE

This introductory section contains the following topics:

INTRODUCTION

r How to use your COULTER r About this manual r Online Help System r Conventions

LH 780 System hard-copy manuals

HOW TO USE YOUR COULTER LH 780 SYSTEM HARD-COPY MANUALS

Use the Reference manual for in-depth information about what the instrument does, the methods it uses, its specifications, and information on installation, safety and software options. The Reference manual for the LH 780 Sy s tem is included in the online Help system; it is available in hard copy by request.

Use the adjust a component on the instrument; and for troubleshooting the instrument. This document is made up of procedures from the online Help system; it is available in hard copy by request.

Use the Instructions for Use for the day-to-day operation of your instrument. This document is made up of procedures from the online Help system; it includes Startup, running controls and samples, reviewing data, Shutdown, and the software on the Analyzer and the Workstation. This document is available in hard copy by reques t.

Use the does, the methods it uses, its specifications, and information on installation, safety and software, as well as day-to-day operating and troubleshooting your SlideMaker. This document is made up of procedures from the online Help system; it is available in hard copy by request.

Special Procedures and T r oubleshooting

SlideMaker Operator’s Guide

for in-depth information about what the SlideMaker

manual to run calibration; to clean, r eplace or

Use the SlideStainer Operator’s Guide for the day-to-day operating and troubleshooting of your SlideStainer. This document is made up of procedures from the online Help system; it includes in-depth information about what the SlideStainer does, the methods it uses, its specifications, and information on installation, safety and software. This document is available in hard copy by request.

Use the Host Transmission Specification to find the information needed to program the transmission interface between the LH 780 System and your laboratory’s host computer. This document is available in hard copy by request.

See the Documentation page on the back cover of this manual for the contents of each ma nual. It can help you to determine quickly in which manual the information you need is located.

PN 773022BE

xiii

INTRODUCTION

ABOUT THIS MANUAL

Your LH 780 System Operator’s Guide is a source of information for the day-to-day operation of your instrument. This information is organized as follows:

s Chapter 1, Controls and Indicators

Provides description of controls and indicators on the Analyzer, Diluter, Power Supply and Works tation.

s Chapter 2, Startup

Provides procedures to check the instrument during daily Startup.

s Chapter 3, Quality Control (QC)

Provides procedur es for running and reviewing controls.

s Chapter 4, Run Samples

Provides description of aspiration and test modes, procedures for collecting and storing specimens, applying bar-code labels, checking instrument setup, identifying samples and cycling samples.

s Chapter 5, Reviewing Data

Provides procedures for reviewing, editing and saving results.

s Chapter 6, Shutdown

Provides procedur es for shutting down the system.

s Chapter 7, DataBase and ToDo List

Provides an overview of the window and the common functions available, and procedures for reviewing, editing, searching and saving results.

s Chapter 8, Setup

Provides procedures for setting up controls, patient envir onment, physician list, location list, institution, communications, passwords, control panel and Run Configuration.

s References s Index, hard copy only.

ONLINE HELP SYSTEM

The Workstation has a comprehensive Online Help System, which includes reference information, all operating, maintenance and troubleshooting procedures. On the LH

Workstation, select to access Help.

CONVENTIONS

This document uses the following conventions:

xiv

indicates a key on the Numeric keypad.

indicates a key on the LH Workstation keyboard.

is the icon for Patient results on the LH Workstation.

is the icon for the Printer on the LH Workstation.

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1.1 ANALYZER

The Analyzer is a subsystem of the LH 700 Series System that physically sits on top of the Diluter. Move the cursor over the illustration to see links to additional information.

CONTROLS AND INDICATORS

Analyzer Screen and CRT Buttons

*SYSTEM RUN* 04/30/05 12:30:18

STATUS : READY ALERT: MODE: C/D/R

BLOOD DETECT: ON

ASPIRATIONS/TUBE 01

PRIME APERT

TEST MODE

MAIN MENU

04/30/05 12:30:18

STATUS: READY ALERT: MODE: C/D/R

BLOOD DETECT: ON

DRAIN RINSE CLEAR

START UP

SHUT DOWN

III

VII

VIII

APERT

*SYSTEM RUN*

ASPIRATIONS/TUBE 01

III

TEST MODE

VII

VIII

MAIN MENU

ALARM

STOP PREMIX START

RESET

CONT

3 6

POWER ON

T E

POWER OFF

The Analyzer has a set of CRT buttons and a screen. The screen displays messages and menu items. Press the buttons to the right of the screen to perform LH 700 Series System functions.

PN 773022BD

1-1

CONTROLS AND INDICATORS

DILUTER

1.2 DILUTER

This is the fluidics portion of the LH 700 Series System. The Diluter is the subsystem that aspirates the sample, dilutes it and mixes it. Move the cursor over the illustration to see links to additional information.

LH 780

Numeric Keypad

Move the cursor over the illustration in Help to see links to additional information.

PRIME

APERT

The Analyzer contains a keypad and a small Liquid Crystal Display (LCD). Use the keypad to initiate Diluter functions or provide numeric values.

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

STOP PREMIX START

2 5 8 0

3 6

POWER ON

T E

POWER OFF

CONT

ALARM

RESET

1-2

PN 773022BD

Numeric Keypad--.

Press to add a decimal point.

Numeric Keypad--0-9

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

CONTROLS AND INDICATORS

DILUTER

STOP PREMIX START

4 7

POWER ON

8 0

T E

POWER OFF

CONT

ALARM

RESET

Press these keys to specify a numeric function you want to perform. You also use these keys to provide sample ID information.

Example: Press to specify the Prime CBC Lytic Reagent function.

Numeric Keypad--Alarm Reset

ALARM

RESET

Press To silence the alarm that sounds when the instrument encounters a problem, such as a low reagent.

PRIME

DRAIN RINSE CLEAR

APERT

E N T E

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

START UP

SHUT DOWN

APERT

1 4 7

2 5

STOP PREMIX START

POWER ON

N T E

POWER OFF

STOP PREMIX START

POWER ON

N T E

POWER OFF

CONT

ALARM

RESET

ALARM

RESET

PN 773022BD

1-3

CONTROLS AND INDICATORS

DILUTER

Numeric Keypad--CE

Press prior to pressing to clear the previous entry and respecify a

sample ID or an function.

When you press , this button is

inactive. You must press or press the Analyzer reset button to exit the current function or remove the current sample ID from memory.

PRIME

E N T E R

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

2 5

STOP PREMIX START

POWER ON

POWER OFF

CONT

ALARM

RESET

E N T E R

STOP

Numeric Keypad--CLEAR APERT

CLEAR APERT

Press to dislodge debris in the apertures by applying pressure behind the apertures. This function also allows the waste chamber to drain.

CLEAR APERTURES appears on the Numeric Keypad during this processing. READY appears upon completion of this processing.

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

STOP PREMIX START

POWER ON

T E

POWER OFF

CONT

ALARM

RESET

1-4

PN 773022BD

Numeric Keypad--DRAIN

CONTROLS AND INDICATORS

DILUTER

DRAIN

Press to: Empty the RBC bath and the vacuum

isolator chamber into the waste chamber.

Empty the WBC bath through the Hgb cuvette into the waste chamber.

DRAIN appears on the Numeric Keypad during this processing. READY appears upon completion of this processing.

Numeric Keypad--ENTER

E N

T E R

Press after you provide a sample identification or specify a function.

PRIME

DRAIN RINSE CLEAR

APERT

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

START UP

SHUT DOWN

APERT

STOP PREMIX START

3 4 7

POWER ON

8 0

T E

POWER OFF

STOP PREMIX START

POWER ON

T E

POWER OFF

CONT

ALARM RESET

ALARM

RESET

E N T

Example: Press to specify the Prime CBC Lytic Reagent function.

If a function is active, press this button a second time to perform the function again.

PN 773022BD

1-5

CONTROLS AND INDICATORS

DILUTER

Numeric Keypad--F

Press before you specify the number of a function you want to perform.

Example: Press to specify the Prime CBC Lytic Reagent function.

E N T E R

Press to repeat the function.

PRIME

DRAIN RINSE CLEAR

APERT

E N T

START UP

SHUT DOWN

APERT

1 4 7

2 5 8 0

STOP PREMIX START

3 6

POWER ON

T E

POWER OFF

CONT

ALARM RESET

Example: After pressing

E N T

, press

(only) to repeat the function.

Numeric Keypad--ID

Press and then specify the sample identifier for a sample you want to cycle in Manual aspiration mode.

Numeric Keypad--POWER OFF

POWER OFF

Press to turn the instrument off. The Workstation and printer remain turned on.

E N T E R

PRIME

DRAIN RINSE CLEAR

APERT

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

START UP

SHUT DOWN

APERT

STOP PREMIX START

1 4 7

POWER ON

5 8 0

T E

POWER OFF

STOP PREMIX START

POWER ON

POWER OFF

CONT

ALARM

RESET

ALARM

RESET

1-6

PN 773022BD

Numeric Keypad--POWER ON

Press to turn the instrument on.

The instrument: Performs reagent and waste level

sensing. When level sensing indicates low reagent or full waste conditions, the instrument displays a message on the Numeric Keypad and stops.

Initializes the Analyzer and Diluter hardware and software.

Puts various mechanical devices into the correct starting position.

POWER ON

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

CONTROLS AND INDICATORS

STOP PREMIX START

POWER ON

T E

POWER OFF

DILUTER

CONT

ALARM

RESET

Displays the current version of the instrument.

When the POWER ON process completes its cycle, READY appears on the Numeric Keypad and on the Analyzer. To operate the instrument, you must also ensure the Workstation and printer are turned on.

Numeric Keypad--PREMIX

PREMIX

Press to mix samples by rocking the bed for about 1 minute before

Automatic aspiration mode starts. AUTOMATIC MODE appears on the

Numeric Keypad during this processing. READY appears upon completion of this processing.

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

STOP PREMIX START

1 4

2 5

POWER ON

T E

POWER OFF

CONT

ALARM RESET

PN 773022BD

1-7

CONTROLS AND INDICATORS

DILUTER

Numeric Keypad--PRIME APERT

PRIME

APERT

Press to: Ensure pneuma tics are ON and at

correct operating levels. Drain and rinse baths. Apply vacuum to apertures to remove

bubbles from lines to vacuum isolators. Ensure aperture current is ON. PRIME APERTURES appears on the

Numeric Keypad during this processing. READY appears upon completion of this processing.

Numeric Keypad--RINSE

RINSE

Press to: Fill the RBC and WBC baths with

diluent. Empty the waste chamber.

PRIME

DRAIN RINSE CLEAR

APERT

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

START UP

SHUT DOWN

APERT

STOP PREMIX START

1 4

1 4 7

2 5

POWER ON

2 5 8 0

T E

POWER OFF

STOP PREMIX START

3 6

POWER ON

T E

POWER OFF

CONT

ALARM

RESET

ALARM

RESET

1-8

RINSE appears on the Numeric Keypad during this processing. READY appears upon completion of this processing.

PN 773022BD

Numeric Keypad--SHUT DOWN

Press to: Rinse all lines. Perform daily instrument cleaning by

introducing cleaning agent into the Diluter to prevent protein buildup.

Check Wa ste level and notify you if a full condition exists to avoid biohazard overflow.

Turn the compressor off.

Note:

manually turned off until all slide processing has been completed at the SlideMaker.

SHUT DOWN

The LH compressor should not be

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

CONTROLS AND INDICATORS

STOP PREMIX START

POWER ON

T E

POWER OFF

DILUTER

CONT

ALARM

RESET

SHUTDOWN appears on the Numeric Keypad during this processing. COMPRESSOR OFF appears upon completion of this processing. When the instrument is in SHUTDOWN, the only function that can be performed is

START UP

Numeric Keypad--START UP

START UP

Press to: Flush the cleaning agent out of the

Diluter components and tubing. Prime the Diluter with CBC, Diff and

Retic reagents. Perform fluidic and electronic checks,

such as background, ramp, and precision tests.

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

STOP PREMIX START

POWER ON

POWER OFF

CONT

ALARM RESET

PN 773022BD

START UP

appears on the Numeric Keypad during this processing. appears upon completion of this processing.

READY

1-9

CONTROLS AND INDICATORS

DILUTER

Numeric Keypad--START/CONT

START

CONT

Press to start or continue automatic sample processing.

The instrument: Automatically primes. Rocks the bed at least 14 times to mix

samples before aspiration. Checks reagent, waste, sheath tank and

backwash tank levels prior to aspirating each sample.

Checks for flow cell clogs. Reads the blood detector sensors to

determine aspiration quality. Ignores all other Numeric Keypad

entries during processing. AUTOMATIC MODE appears on the

Numeric Keypad during this processing. READY appears upon completion of this processing.

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

STOP PREMIX START

1 4

2 5

POWER ON

T E

POWER OFF

CONT

ALARM RESET

1-10

PN 773022BD

Numeric Keypad--STOP

CONTROLS AND INDICATORS

DILUTER

STOP

Press to stop processing samples after the current sample cycles. After stopping processing, the instrument drains and rinses the Hgb cuvette.

If the rocker bed is mixing samples, pressing this button stops the mixing process.

If the instrument is performing an

function, this button exits function.

STOP

Press twice to release the stripper plate.

Before continuing processing, verify the position of the next tube you want sampled. The system does not remember how many aspirations it has

START

CONT

already made. When you press , the system performs the total number of aspirations originally selected.

PRIME

DRAIN RINSE CLEAR

APERT

START UP

SHUT DOWN

APERT

STOP PREMIX START

POWER ON

T E

POWER OFF

CONT

ALARM

RESET

PN 773022BD

STOP

Note: Pressing does not stop startup or shutdown cycles.

1-11

CONTROLS AND INDICATORS

POWER SUPPLY

1.3 POWER SUPPLY

Side/Front

The Power Supply allows you to monitor:

r Pressure r Vacuum r Voltage r Temperature.

The Power Supply also allows you to adjust pressure. When the Power Supply is unplugged, the system receives no power.

1-12

PN 773022BD

Back

CONTROLS AND INDICATORS

POWER SUPPLY

POWER TO

DILUTER

PRESSURE TO DILUTER

250V FUSES

POWER

PRIMARY

POWER

CORD

POWER SUPPLY

Power Supply Function Levels

The actual level of the function appears on the display. The levels are updated automatically whenever changes occur.

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

30.0

30.0 28

30.0 5.0

5.0 28

5.0

115

11560

115

60 PSI pressure level. This should be

AC DC

±5 PSI.

30 PSI pressure level. This should be 30 ±1 PSI.

5 PSI pressure level. This should be 5

±0.1 PSI.

V ACUU M supply level. This should be 22 in. Hg minimum at sea level.

AC LINE (input voltage) level. This should be between 90 V and 264 V.

PN 773022BD

1-13

CONTROLS AND INDICATORS

POWER SUPPLY

Power Supply Function Status

Green indicates the function is within normal range; red indicates outside normal range.

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

60 PSI 30 PSI 5 PSI VACUUM AC LINE

PNEU TEMP

30.0

5.0 28

115

Input Power (AC) Status

AC DC

Output Voltage (DC) Status

AC DC

Pneumatic (PNEU) Status

AC DC

Power Supply Temperature (TEMP)

Status

Power Supply Adjustment Controls

Note: When adjusting PSI pressure, adjust to the midpoint.

Tu rn ad justment controls clockwise to increase pressure; counterclockwise to reduce pressure.

5 PSI

ADJUST

5 PSI

ADJUST

30 PSI

ADJUST

30 PSI

ADJUST

60 PSI

ADJUST

60 PSI

ADJUST

1/16A 250 V

F3 1/16A 250 V

MAIN

POWER

0 N

MAIN

POWER

S U F

5-PSI pressure level. This should be

0 F

5 ±0.1 PSI.

30-PSI pressure level. This should

be 30 ±0.1 PSI.

1-14

PN 773022BD

CONTROLS AND INDICATORS

POWER SUPPLY

5 PSI

ADJUST

5 PSI

ADJUST

30 PSI

ADJUST

30 PSI

ADJUST

60 PSI

ADJUST

60 PSI

ADJUST

F3 1/16A 250 V

MAIN

POWER

MAIN

POWER

60-PSI pressure level. This should

E S

be 60 ±5 PSI.

Master circuit breaker

E S

enables/disables input power reaching internal electrical components of the Power Supply.

PN 773022BD

1-15

CONTROLS AND INDICATORS

GEN•

WORKSTATION

1.4 WORKSTATION

CAUTION

Possible system damage could occur if the LH Workstation is used to operate personal software that has not been authorized for use by Beckman Coulter. Only use software that is authorized by Beckman Coulter.

The Workstation:

r Stores and recalls sample data r Automates QC and calibration

procedures

r Assists you in troubleshooting.

N E C

M u l t i S y n c L C D 1 7 0 0 m +

CD ROM Drive

3.5-inch Diskette Drive

Your Workstation uses a Compact Disk Read-Only Memory disk drive to read data from a CD ROM disk, such as the Audio Visual Help CD-ROM. This CD-ROM holds text, graphics and hi-fi stereo sound.

Use this diskette drive for inserting diskettes.

1-16

PN 773022BD

Power On/Off (Workstation)

Workstation Keyboard

CONTROLS AND INDICATORS

WORKSTATION

Before turning the W orkstation off, you should try to shut down the Workstation to avoid loss of any data. If you cannot shut down the Workstation, turn the Workstation off, wait 30 seconds and restart the Workstation.

Press this button to turn the Workstation on or off.

You can use the keyboard as an alternate method of interacting with the W orkstation. Press

to access Help

Alt

to access the menu bar

Tab

to move between fields

to move within a field.

PN 773022BD

1-17

CONTROLS AND INDICATORS

WORKSTATION

Monitor and Volume Controls

Press Auto to change the monitor settings. Refer to the instructions in the manual that came with your monitor.

E x i t E n t e r

A u t o

Using Command Center

The LH W orkstation always appears with a light green Command Center at the bottom of the screen. This area provides quick access to functions and system status.

Buttons

The buttons on the Command Center enable you to access major Workstation functions:

Select To Access

Run Configuration application where you can quickly change defaults for workflow preferences.

Patient application where you can review, report and modify existing patient sample results and add new patient sample requests.

1-18

Quality Assurance application where you can review results for the various quality assurance methods, such as controls, Extended QC, XB, Xm, and calibration.

System Setup application where you can customize your LH Workstation to your laboratory workflow preferences, such as flagging limits and decision rules.

History Log Viewer application where you can review and comment on messages posted to various electronic logbooks that identify history.

System Status application where you can view current details about the system. The Shutdown Type window so you can logoff or shutdown your Workstation.

PN 773022BD

CONTROLS AND INDICATORS

WORKSTATION

Process Type

This field displays the current processing of the sample analysis data received fr om the instrument. To change the process type:

1. Select for the process type.

2. Select the type of processing you want for the instrument:

Select For Results Considered As From

AUTO ANALYSIS

Any automatic identification of the type of run. This includes all patient and bar-coded control analyses.

REPRODUCIBILITY CARRYOVER CALIBRATION CONTROL

Reproducibility analysis. Carryover analysis. Calibration analysis. Control analysis.

Note: If a sample tube does not have a bar-code label and the r esults are to be sent to a specific Control Folder, select

CONTROL and select the target Control Folder Lot Number using the

Default Cell Control field on the Run Configuration screen. Use the CONTROL mode when using Other Controls (Non BCI) to prevent the SlideMaker from aspirating.

The next time the Workstation receives data from the instrument, it stores it in the database according to your selection.

Bar-code ID Field

1. Select this field.

2. Use the handheld scanner to scan the sample ID for the next sample cycled in Manual aspiration mode or perform the following procedure:

a. Using the Workstation keyboard, type a sample ID that you want used for the next

PN 773022BD

Tab

sample cycled in Manual aspiration mode, and then press .

IMPORTANT

1. DO NOT use the following characters # @ [ \ ] ` { | } ~ in Specimen or Patient identifiers. There is a potential for Specimen or Patient misidentification to occur. The system will substitute or omit these characters when the system is configured in a language other than English or Chinese.

2. Risk of missing identifier. If you fail to send the sample ID to the instrument within 60 seconds of data entry in the Bar-code ID field, the sample ID provided is cleared. This minimiz es the risk of sample misidentification.

b. Press , then to send the Barcode ID to the Analyzer. After the Ba rcode

ID appears on the Analyzer. ENTER ACCEPT/STOP REJECT appears on the Numeric Keypad.

1-19

CONTROLS AND INDICATORS

WORKSTATION

c. Press 0 to accept the Barcode ID or to reject the Barcode ID. d. Ensure the Sample ID is correctly displayed at the analyzer screen.

Status Area

Graphics appear in this area to provide status about the system.

This Means

E N T E R

STOP

The system is functioning properly. (GREEN)

The system recognized an event that might have caused it to stop processing, but the automatic stop option was turned off. Check for additional status graphics to indicate the nature of the event. You can also check the History Logs for detailed messages. (YELLOW)

The system encountered an event that caused it to stop processing. This could be due to an automatic stop option or error condition. Check for additional status graphics to indicate the nature of the event. You can also check the History Logs for detailed messages. (RED)

When an event causes the system to stop processing, double-click on the traf fic light to display the Status dialog box. Place the cursor over an entry in the Status box to display additional information. Double-click on an entry in the Status box if you want to display the error message help topic for that event.

Select to accolade the event and continue processing. The Review folder contains one or more samples.

An Analytical Station attached to the Workstation stopped processin g and sent a message to the Workstation that it should stop. Check the History Logs for detailed messages.

The database is functioning improperly. Shut down and restart the Workstation. If the problem persists, call your Beckman Coulter Representa tiv e .

Information systems communications is functioning improperly. Check the History Logs for detailed messages.

Last control results were outside the defined limits. Check the History Logs for detailed messages.

1-20

Last batch of XB results was outside the defined limits. Check the History Logs for detailed messages.

PN 773022BD

CONTROLS AND INDICATORS

WORKSTATION

Last batch of Xm results was outside the defined limits. Check the History Logs for detailed messages.

The Remote Communication Service (RCS) is enabled.

The SlideMaker has stopped.

The SlideStainer has stopped.

Default Type

Use to select the default test type for sample processing. Options are C, CD, CDR, CR, and R.

Last Message

This field displays the last message posted to the Event history log. If the message is too long to fit in this field, it appears truncated. Select to see the complete message and additional

messages that may have been posted to the log.

Reviewing System Status

In addition to the Command Center that displays system status, you can select to display the Status Application window. This window displays information about your system status:

r Monitor serial number r PC serial number r Other serial numbers r Computer name r Software versions r Installation identification r System revisions r Last Service Maintenance Information

You can also obtain information about the number of records in the database.

PN 773022BD

1-21

CONTROLS AND INDICATORS

WORKSTATION

1-22

PN 773022BD

2.1 LOGGING OFF/ON THE WORKSTATION

Logging OFF

1. Select on the Command Center to display the Log Off window.

2. Select to confirm that you want to log off the current user name and display the Log On window.

Logging ON

1. Type your user name that was defined by your laboratory administrator.

2. Type your password that was defined by your laboratory administrator. If you forget your password, contact your laboratory administrator. Your laboratory administrator can reset your password.

3. Select . The Workstation checks your password and starts the appropriate applications.

STARTUP

2.2 PERFORMING DAILY STARTUP

1. Check to see if the instrument is running properly.

2. If you have system options, such as the LH 700 Series SlideMaker, startup the system option.

3. Press on the Numeric Keypad to enable the automatic startup cycles.

4. Check the startup test results. Note: SlideMaker only: After the workstation receives startup results from the Analyzer,

The SlideMaker will automatically go through its startup cycle if the SlideMaker is in Shutdown. If the SlideMaker is not in Shutdown, request a Startup on the SlideMaker, from the SlideMaker Keypad: Main Menu, Routine Functions, Routine Fluidics.

5. Select on the Command Center to verify the Workstation run configuration.

6. Run your controls

7. Select to print startup results.

Checking Instrument Operation

1. Ve rify that the inst rument has been turned on.

START UP

PN 773022BE

2. If the power is off, press on the Numeric Keypad.

3. While the instrument initializes, you may want to:

4. Collect and prepare samples.

5. Place bar-code labels on sample tubes.

6. Ensure the pneumatics are on.

POWER ON

2-1

STARTUP

PERFORMING DAILY STARTUP

7. If you have not already done so, check the baths to ensure they function properly.

Setting Up Analyzer Date and Time

1. Go to the Analyzer screen.

2. Press

3. Press

4. Press

5. Press

6. Press the button for the setting you want to set up. Example: Press

MAIN MENU. ANALYZER FUNCTIONS. DATE AND TIME. SET DATE & TIME.

MONTH.

7. Go to the Numeric Keypad.

8. Press the value associated with the setting you want to specify. Each setting must be

entered as a two-digit number. Example: Press and then press .

9. Repeat steps 6 through 8 for each setting you want to specify.

10. Press one of the following:

SYSTEM RUN RETURN

To cycle samples. To display the DATE & TIME screen.

Setting Up Analyzer Date Format

E N T E R

1. Go to the Analyzer screen.

2. Press

3. Press

4. Press

5. Press

MAIN MENU. ANALYZER FUNCTIONS. DATE AND TIME. FORMAT until the date format you want to use appears:

r MM/DD/YY r DD/MM/YY r YY/MM/DD

where MM = Month, DD= Day, and YY= last two digits of the Year

6. Press one of the following:

MAIN MENU SYSTEM RUN RETURN

To display the Analyzer MAIN MENU screen. To cycle samples. To display the ANALYZER FUNCTIONS screen .

Turn Pneumatics ON

The Pneumatics are OFF if the Power Supply pneumatics light is red, or if the Analyzer scr een is blank.

2-2

PN 773022BE

PERFORMING DAILY STARTUP

PRIME

APERT

Press on the Numeric Keypad to activate the pneumatic subsystem. The pneumatic subsystem has an automatic shutoff feature to prolong the life of the

compressor and vacuum pump. If the Diluter is idle (not cycled) for about 1 hour, the pneumatic subsystem turns off. Messages that cause the system to stop processing samples inhibit the time-out function.

Checking Power Supply and Vacuum Level

CAUTION System damage or malfunction can occur if you operate the instrument when any indicator is

outside the following limits. Do not operate the instrument if any indicator is outside these limits.

Check the following status and function levels on the Power Supply.

Status or Function Level Should Appear

Input Power (AC) Status

STARTUP

Output Voltage (DC) Status Pneumatic (PNEU) Status Temperature (TEMP) Status 60 PSI

30 PSI 5 PSI

±5 psi ±1 psi

5 ±0.1 psi VACUUM 22 in. Hg minimum at sea level AC LINE 90 - 264 V

Turn adjustment controls clockwise to increase pressure; counterclockwise to reduce pressure. If the vacuum is out of range, call your Beckman Coulter Representative.

Check Baths

1. Open the aperture compartment door.

DRAIN

2. Press on the Numeric Keypad.

3. Verify that both aperture baths drain completely.

RINSE

PN 773022BE

4. Press on the Numeric Keypad.

5. Ve rify that both baths fill with liquid.

6. Verify that the waste chamber drains.

2-3

STARTUP

PERFORMING DAILY STARTUP

7. Close the aperture compartment door.

Automatic Startup Cycles

Pressing starts automatic startup cycles. When you press this button, the system

START UP

flushes the cleaning agent from all Diluter components and tubing if cleaning reagent is not already removed. It also performs electronic and fluidic checks to ensure the instrument is ready to analyze contr o l or whole-blood samples. Specifically, the instrument:

r Performs reagent and waste level sensing. r Replaces the cleaning agent with diluent. r Performs ramp-pulse and precision-pulse tests. r Performs a background count in the baths and flow cell. r Measures Hgb-blank and Hgb-sample voltages. r Performs an electronic check of the Triple Transducer Module (flow cell). r If a SlideMaker unit is attached, it will perform a ventline calibration.

Checking Daily Test Results

1. Select on the Command Center to display the Quality Assurance application.

2. If necessary, select to display the daily startup test results.

3. If you want to see past startup test results: a. Select .

b. Select a row indicating the date, time and type of test results you want to see. The

results appear on the window.

Note: Select only 1 row. Daily Checks results will not be displayed if you select more than 1 row of results.

4. Check the reagent status, background status and subsystem status for any items that failed.

5. Select to see startup test details. You can also select to see background test results on the QA Results & Graphics window.

6. Take appropriate action to r e s o lve any failed items.

Checking Background Test Results

1. Select to display the Quality Assurance application.

2. If necessary, select to display the Daily Checks window.

3. Review the results on the window.

2-4

PN 773022BE

PERFORMING DAILY STARTUP

4. Select to see the specific background Diff test results. Acceptable background results indicate the count did not exceed the preset tolerances. If

results appear with a red background they are unacceptable.

If an incomplete computation (.....) of the Hgb parameter occurs, verify that the Hgb-blank

and Hgb-read voltages are acceptable. If the voltages are acceptable, the dots (.....) for the Hgb

parameter are acceptable. If the voltages are unacceptable, you must repeat the background test.

Checking HGB Voltage Test Results

1. Select to display the Quality Assurance application.

2. If necessary, select to display the Daily Checks window.

3. Review the results on the window.

STARTUP

4. Select to see the Hgb voltage blank and read results.

Checking Instrument Setup

1. Ensure the instrument is running properly.

2. Check the following at the Analyzer:

r No alert messages exist r Blood Detector is ON r Desired test mode is set r Desired number of aspirations per tube is set (For Automatic aspiration mode)

3. If necessary, add tests to the ToDo list.

4. Ensure the W orkstation run configuration is set up corr ectly.

5. On the Command Center, check the instrument

r Process Type. r Default Type

Checking Precision Test Results

1. Select to display the Quality Assurance application.

PN 773022BE

2. If necessary, select to display the Daily Checks window.

3. Review the results on the window.

4. Select to see the results for the precision test.

2-5

STARTUP

PERFORMING DAILY STARTUP

Checking Ramp Test Results

1. Select to display the Quality Assurance application.

2. If necessary, select to display the Daily Checks window.

3. Review the results on the window.

4. Select to see the ramp test results.

Possible Startup Problems and Fixes

When Reagents Fail

1. Ensure reagent information was entered properly.

2. Replace expired reagents.

When Background Fails

1. Perform a background test or rerun startup.

2. If the problem occurs again, call your Beckman Coulter Representative.

When Diluter, Analyzer, Power Supply, Communications, HGB Voltage, or VCS Module Fail

1. Perform a background test, if necessary rerun startup.

2. If the problem occurs again, call your Beckman Coulter Representative.

When Precision Test Fails

1. Verify that clean diluent covers the apertures and that there is no bleach or cleaning agent in the baths.

2. Repeat the precision test at the Analyzer.

3. If the problem occurs again, call your Beckman Coulter Representative.

When Ramp Test Fails

1. Verify that clean diluent covers the apertures and that there is no bleach or cleaning agent in the baths.

2. Repeat the ramp test at the Analyzer.

3. If the problem occurs again, call your Beckman Coulter Representative.

2-6

Running Controls

Refer to Chapter 3, Quality Control, for detailed instructions on running your controls.

PN 773022BE

3.1 QUALITY CONTROL OVERVIEW

IMPORTANT Risk of erroneous results. If you have an LH SlideMaker installed with the LH 780 Analyzer,

refer to the special instructions for Quality Control Processing with LH SlideMaker.

Quality control includes monitoring r outine performance and service in conjunction with the use of controls and calibrators. You should routinely check results between quality control analyses. The combination of these methods provides the assurance of complete quality control.

The LH 700 Series System incorporates multiple quality control techniques. For the CBC, CBC/DIFF and RETIC parameters, the LH 700 Series System uses the established technique of commercial contr ols. The LH 700 Series System uses a stabilized par ticle suspension, such as LATRON, to verify flow cell alignment, gains, and CVs for flow cell volume, conductivity and light scatter (Performing NRBC Quality Control). The Workstation stores information about the control setup and control results in the DataBase.

The LH 700 Series System also allows you to customize the way the Workstation displays control results. Your laboratory can establish acceptance limits for control results based on the control source, type and level, as well as the aspiration mode. This can help you better understand control results and interpret them more quickly.

QUALITY CONTROL

Beckman Coulter recommends that Quality Control checks be performed using patient or commercial controls in both automatic (primary) and manual (secondary) modes at intervals established by your lab. When using a commercial control, refer to the package insert to determine which mode to use. Failure to recover Control values within your lab's expected limits or the presence of unexplained shifts or trends in either mode of analysis should be investigated. If Control problems in either mode cannot be resolved, call your Beckma n Coulter Representative.

3.2 LATRON

Running Latex Control—Diff

1. Perform instrument startup.

2. Check that the instrument process type on the Command Center is set to

3. Ensure the latex primer and control are within the correct temperature range. For

4. Verify the lot number of the primer and control. If you must use a new lot number,

CAUTION Possible system damage could occur if you aspirate anything except latex control or latex primer

using this function. Do not aspirate any other materials with this function.

or CONTROL

COULTER LATRON primer and control the correct temperature range is 18-30°C/64-86°F.

ensure that it has been set up properly.

AUTO ANALYSIS

PN 773022BE

5. Go to the Numeric Keypad.

3-1

QUALITY CONTROL

LATRON

6. Press to aspirate la tex for the Diff test mode. The Numeric

7. Press . The Numeric Keypad displays PRESS MANUAL OR PRESENT SAMPLE.

8. Remove the cap of the latex primer vial.

9. Immerse the aspirator tip in the latex primer vial. The instrument automatically aspirates

10. Remove the vial from the aspirator tip when you hear a beep and the Analyzer Status line

11. At the Workstation, check the results from the primer.

12. If the results in the PRIMER column are less than or equal to 500, proceed to step 12.

E N T

5 5

E R

Keypad displays PRESS MANUAL OR CLEAR APERTURE.

CLEAR APERT

the primer. The Numeric Keypad displays DIFF PRIMER while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 55.

displays PREPARING SAMPLE. The aspirator tip automatically retracts and the probe wiped cleans it.

Otherwise, if the results in the PRIMER column are greater than 500:

E N T E R

a. At the Numeric Keypad, press to reactivate the function for the control. The

Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE. b. Perform steps 6 through 9 up to three more times. c. If you do not get a result below 500, cycle a new vial of primer. d. If you still do not get a result below 500, call your Beckman Coulter Representative.

E N T E R

13. At the Numeric Keypad, press to reactivate the function for the latex control. The Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

IMPORTANT Erroneous results could occur if you press CLEAR APERTURE before aspirating latex control.

CLEAR APERTURE is only used before aspirating latex primer in this procedure.

14. Gently mix the latex control according to the directions in the package insert.

15. Immerse the aspirator tip in the latex control vial. The instrument automatically aspirates the control. The Numeric Keypad displays LATEX—DIFF while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 55.

16. At the Workstation, verify the results from the control.

3-2

PN 773022BE

QUALITY CONTROL

STOP

17. At the Numeric Keypad, press twice to exit this function. The Numeric Keypad displays READY.

Running Latex Control—Retic

1. Perform instrument startup.

2. Check that the instrument process type on the Command Center is set to

or CONTROL.

3. Ensure the latex primer and control are within the correct temperature range. For COULTER LATRON primer and control the correct temperature range is 18-30°C/64-86°F.

4. Verify the lot number of the primer and control. If you must use a new lot number, ensure that it has been set up properly.

CAUTION Possible system damage could occur if you aspirate anything except latex control or latex primer

using this function. Do not aspirate any other materials with this function.

AUTO ANALYSIS

LATRON

5. Go to the Numeric Keypad.

E N T E

6. Press to aspirate latex for Retic test mode. The Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

CLEAR

APERT

7. Press . The Numeric Keypad displays PRESS MANUAL OR PRESENT SAMPLE.

8. Remove the cap of the latex primer vial.

9. Immerse the aspirator tip in the latex primer vial. The instrument automatically aspirates the primer. The Numeric Keypad displays RETIC PRIMER while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 56.

10. Remove the vial from the aspirator tip when you hear a beep and the Analyzer Status line displays PREPARING SAMPLE. The probe cleaner retracts the aspirator and automatically cleans it.

11. At the Workstation, check the results from the primer.

12. If the results in the PRIMER column are less than or equal to 500, proceed to step 12. Otherwise, if the results in the PRIMER column are greater than 500:

PN 773022BE

E N T E R

a. At the Numeric Keypad, press to reactivate the function for the control. The

Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

b. Perform steps 6 through 9 up to three more times.

3-3

QUALITY CONTROL

LATRON

13. At the Numeric Keypad, press to reactivate the function for the latex control. The

IMPORTANT Erroneous results could occur if you press CLEAR APERTURE before aspirating latex control.

CLEAR APERTURE is only used before aspirating latex primer in this procedure.

14. Gently mix the latex control according to the directions in the package insert.

15. Immerse the aspirator tip in the latex control vial. The instrument automatically

c. If you do not get a result below 500, cycle a new vial of primer. d. If you still do not get a result below 500, call your Beckman Coulter Representative.

E N T E R

Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

aspirates the control. The Numeric Keypad displays RETIC--LATEX while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 56.

16. At the Workstation, verify the results from the control.

STOP

17. At the Numeric Keypad, press twice to exit this function. The Numeric Keypad displays READY.

Running Latex Control—Diff and Retic

1. Perform instrument startup

2. Check that the instrument process type on the Command Center is set to

or CONTROL

3. Ensure the latex primer and control are within the correct tem pera ture range. For COULTER LATRON primer and control the correct temperature range is 18-30°C/64-86°F.

4. Verify the lot number of the primer and control. If you must use a new lot number, ensure that it has been set up properly.

CAUTION Possible system damage could occur if you aspirate anything except latex control or latex primer

using this function. Do not aspirate any other materials with this function.

5. Go to the Numeric Keypad.

6. Press to aspirate LA TEX primer and LATEX control for combined Diff and Retic test modes. The Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

AUTO ANALYSIS

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CLEAR APERT

7. Press . The Numeric Keypad displays PRESS MANUAL OR PRESENT SAMPLE.

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5C SERIES CELL CONTROL AND RETIC-C

8. Remove the cap of the latex primer vial.

9. Immerse the aspirator tip in the latex primer vial. The instrument automatically aspirates the RETIC+DIFF primer. The Numeric Keypad displays RETIC+DIFF PRIMER while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 57.

10. Remove the vial from the aspirator tip when you hear a beep and the Analyzer Status line displays PREPARING SAMPLE. The probe cleaner retracts the aspirator and automatically cleans it.

11. At the Workstation, check the results from the primer.

12. If the results in the PRIMER column are less than or equal to 500, proceed to step 12. Otherwise, if the results in the PRIMER column are greater than 500:

E N T E R

a. At the Numeric Keypad, press to reactivate the function for the control. The

Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

b. Perform steps 6 through 9 up to three more times. c. If you do not get a result below 500, cycle a new vial of primer. d. If you still do not get a result below 500, call your Beckman Coulter Representative.

E N T E R

13. At the Numeric Keypad, press to reactivate the function for the latex control. The Numeric Keypad displays PRESS MANUAL OR CLEAR APERTURE.

IMPORTANT Erroneous results could occur if you press CLEAR APERTURE before aspirating latex control.

CLEAR APERTURE is only used before aspirating latex primer in this procedure.

14. Gently mix the latex control according to the directions in the package insert.

15. Immerse the aspirator tip in the latex control vial. The instrument automatically aspirates the control. The Numeric Keypad displays RETIC+DIFF--LATEX while the instrument performs this function. When this function completes processing, the Numeric Keypad displays FUNCTION = 57.

16. At the Workstation, verify the results from the control.

STOP

17. At the Numeric Keypad, press to exit this function. The Numeric Keypad displays READY.

3.3 5C SERIES CELL CONTROL AND RETIC-C

Cycling Controls

If you have an LH SlideMaker, follow the instructions contained in Quality Control Processing with LH SlideMaker (refer to your Coulter LH SlideMaker Operator’s Guide).

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5C SERIES CELL CONTROL AND RETIC-C

1. Ensure the instrument is set up for the appropriate control.

2. Prepare the controls according to the directions in the package insert.

3. Ensure the controls are properly set up on the Workstation. Note: If you run a Beckman Coulter control without setting it up, the Workstation

automatically creates control setup information for you. The control information identifies the lot number, source, type and level of the control.

4. Load the cassette with the control material.

5. Place the cassette firmly and securely into the loading bay. The instrument begins to cycle the controls.

6. On the Command Center, select have bar-code labels. See process type if you run controls without bar-code labels.

Note: Use the

CONTROL process type only if you are using a non-bar-coded control or a

tube with a damaged bar-code.

7. Review the control results.

Aspirate Control in Manual Mode

AUTO ANALYSIS as the process type if your control tubes

Optical sensors exist at the bottom of the activator.

IMPORTANT Risk of misleading results. Holding the tube against the bottom of the aspirator tip can

prevent aspiration. Do not hold the tube against the bottom of the aspirator tip.

IMPORT ANT Risk of misleading results. Removing a sample tube from the aspirator tip before the ST ATUS

message changes and you hear a beep could cause a short sample aspiration. Wait until the message changes and you hear a beep to remove the sample tube.

WARNING Risk of personal injury. If the optical sensors do not detect an obstruction, the aspirator tip

retracts when PRIME appears on the STATUS field on the Analyzer screen. If you have the aspirator tip immersed in the tube when the tip retracts, the aspirator can hit the tube and break it. Be sure to remove the sample tube when the instrument beeps and be clear of the aspirator tip before PRIME appears. If a tube should break, use your laboratory’s safety procedure for cleaning the broken glass.

Immerse the aspirator tip in the sample such that the tube or your hand blocks the optical sensors. The instrument automatically aspirates the sample.

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5C SERIES CELL CONTROL AND RETIC-C

When the instrument beeps, remove the sample. The instrument automatically cleans the aspirator tip with a probe wipe.

Reviewing Control Results

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the Controls window.

3. Select the control folder for which you want to view results.

4. Select the specific control for which you want to review results. The control results table, statistics and graphs appear on the window. Use the scroll bars on the window to view

other parameter results and graphs. Use to add comments to a control run.

5. If you want to view the results and graphics for a specific latex run: a. Select the control run you want to view in the table.

b. Select to see the Latex Graphs window.

6. Select:

This To Do This

Adjust assigned values to the current mean values. Restore the manufacturer’s assigned values and expected ranges. Select Active, Accumulating or Inactive from the drop down box.

Control Codes and Flags

As appropriate, the LH 700 Series System applies instrument-generated and/or laboratory-defined flags, codes, and/or messages to each set of patient results. Flags, codes, and suspect or definitive messages are used to alert you to an instrument malfunction, specimen abnormality, abnormal data pattern, or abnormal results. Beckman Coulter recommends review, appropriate to the requirements of the patient population, of all results displaying a flag, code or message.

The following codes appear in place of results when the system cannot obtain results:

..... Incomplete computation. When this code occurs for a parameter result it indicates

an incomplete computation due to problems such as data insufficiency.

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When this code appears on all parameter results, it indicates a Power Supply Failure. Check this condition and rerun the sample

- - - - - When this code appears for CBC parameter results and no average histogram appears for the affected parameter, it indicates a total voteout.

+++++ The result exceeds the instrument's operating range. Follow your laboratory’s

policies for reviewing the sample.

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QUALITY CONTROL

5C SERIES CELL CONTROL AND RETIC-C

IMPORT ANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have +++++ (code) when cycling in

Manual mode, run a blank cycle before analyzing the next test sample to prevent carryover to the next sample. When cycling in Automatic mode, rerun the sample immediately following the one with the +++++. Sample dilutions may also result in wrong differential results. The instrument will automatically set to CBC mode when predilute is chosen.

::::: The instrument detected a clog in the flow cell. You must clear the clog and

rerun the sample.

????? I nvalid data.

The following flags appear to the right of the parameter result:

* Result exceeds instrument's counting threshold. Follow your laboratory's policies

for reviewing the sample. This flag is applicable to MCV only.

+ Result exceeds linearity (reportable) range. Follow your laboratory’s policies for

reviewing the sample.

H Result is higher than your reference range. Follow your laboratory’s policies for

reviewing the sample.

L Result is lower than your reference range. Follow your laboratory’s policies for

reviewing the sample.

P Partial aspiration detected. R Review the result according to your laboratory's protocol. When editing parameter

results, this flag requir es special handling. Any parameter derived from an R-flagged parameter cannot be recalculated until the parameters with the R flags have been edited.

When a Control is Outside Its Expected Ranges

1. Ensure the control:

r Material was mixed properly. If not, mix it according to the package insert. r Identification information was entered correctly. If using a bar-code reader, ensure

the bar-code labels are clean and positioned correctly. If using the Numeric Keypad, ensure you typed the correct information.

r Setup information (assigned values and expected ranges) matches the control

package insert. If they do not, change the control’s information to match the package insert.

2. If any of the problems existed, rerun the control; otherwise, proceed to the next step.

3. Rerun the control to ensure the problem was not a statistical outlier.

4. Ensure the control material was not contaminated by running another vial or level of control.

5. Watch for normal sample flow as part of troubleshooting the instrument. If necessary, call your Beckman Coulter Representative.

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5C SERIES CELL CONTROL AND RETIC-C

When a Latex Control is Outside its Expected Ranges

1. Ensure the control setup information (as signed values and expected ranges) matches those on the package insert. If they do not, change the control information to match the package insert, then rerun the control.

2. Ensure no bubbles exist in the flow cell by rerunning the primer and the control. If the control is still outside the expected ranges:

a. Go to the Numeric Keypad. b. Use F13 to purge the flow cell. c. Run primer and control again.

3. Check the control: a. Ensure the control is not contaminated, properly mixed, and not expired: b. Ensure the aspirator tip is clean and dry. c. If necessary, use a new vial of latex control. Be sure to mix it according to the

directions on the package insert.

4. Ensure the flow cell is clear by performing the procedure for clearing a clogged flow cell.

5. Rerun the control. If the control is still outside the expected ranges, call your Beckman Coulter Representative. You can set the instrument to CBC mode and continue to process CBC samples.

Controls Window

This window enables you to see control information stored in the database.

Finding Control Results

Use the following to find the information and sort the information displayed on this window.

Use This To Do This

Select this graphic to expand the list of control categories. You can double-click the folder beside this graphic to perform the same function.

Select this graphic to collapse the list of control categories. Y ou can double-click the folder beside this graphic to perform the same function.

By default, control lots have an active status. Active control lots are files that are currently in use. Control lots with an Active status are evaluated and stored, and event log messages, alarms and stop conditions are triggered as applicable.

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Accumulating control lots are utilized during crossover studies. Control lots with an Accumulating status will not trigger event log messages, alarms and stop conditions. Processing is otherwise the same as Active State.

Control lots with an Inactive status are no longer in use. No new data will be added to a lot with an Inactive status.

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QUALITY CONTROL

5C SERIES CELL CONTROL AND RETIC-C

Transmit, Print and Archive

Standard buttons appear at the top of this window. These buttons enable you to perform actions on the items that appear in the control results grid. You can perform these actions on multiple items at a time.

1. Select an item in the control results grid on the right side of the window. If you want to

Double-click one of the source folders to expand or collapse the list of control types for the selected control source.

Double-click one of the folders representing a control type to expand or collapse the list of lot numbers for the selected control source and type.

Select a lot number folder to see the details for the control runs of the selected source, type and lot.

The control results grid displays the r esults.

perform the same action on all items, select .

2. Select the relevant button to perform the action it represents. For example, select a lot number and then select to print the control results.

Deleting Control Data

1. Select in the Quality Assurance application. The CONTROLS window appears.

2. Determine what you want to delete: r If you want to delete specific control runs, select the control runs you want to delete

by selecting the row number that contains the control results. Selected rows appear with a black background.

r If you want to delete all the control runs for a specific lot number, select the lot

number by selecting its file folder.

r If you want to delete all the information associated with a lot number, including the

setup information, select the lot number by selecting its file folder.

3. Select to display the Control Data — DELETION REQUESTED window.

4. Verify the data you want to delete.

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5. Select to delete the data. A message that asks you to confirm your request appears.

6. Select to delete the data. The Workstation deletes the selected data. The data cannot be retrieved.

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5C SERIES CELL CONTROL AND RETIC-C

Adjusting Control Limits

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the Controls window.

3. Select the specific control for which you want to adjust limits. The control results table, statistics and graphs appear on the window.

4. Select to replace the assigned values on this window with the values that currently appear as the mean values. The Workstation also replaces the expected ranges. The Workstation now displays the Lab Target and Lab Limit values.

Providing Comments for Quality Assurance

1. Select on the Command Center to display the Quality Assurance application.

2. Select the control file and run for comment addition.

3. Select . The Comments window appears.

4. Type the comments you want to provide.

5. Select to save the comments. For control runs, appears in the CMNT column to indicate that it has a comment.

Performing NRBC Quality Control

1. Ensure the daily quality assurance for the LH 700 Series CBC and VCS subsystems is acceptable, including:

a. Startup, including backgrounds b. For the CBC and DIFF parameters, the LH 700 Series uses the established technique

of commercial controls.

c. For the DIFF parameters, the LH 700 Series uses a stabilized particle suspension,

such as LATRON, to verify flow cell alignment, gains, and CVs for flow cell volume, conductivity and light scatter.

2. Use the LH 700 Series to screen for positive and negative control samples. a. A negative control is a sample that reports 0% NRBC. b. A positive control is a sample that reports

control samples should be reviewed to ensure that the presence of a known interference is unlikely to affect accuracy of the NRBC. The known interferences are listed in HELP under Performance Characteristics / Known Limitations and Interfering Conditions / NRBC.

3. Record all values and calculations on the NRBC Control Table. The reference to the correct column in the table is shown as an upper case alpha character; for example, LH 700 Series values should be recorded in columns A and F.

>2% and <15% NRBC. NOTE: Positive

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5C SERIES CELL CONTROL AND RETIC-C

4. Make two peripheral smears for each control sample. Stain according to your laboratory protocol.

5. Enumerate the NRBC/100 WBC from each slide using two technologists counting 200 cells per slide, as follows:

Slide 1 Tech 1, 200 cells (column B)Tech 1, 200 cells (column

Slide 2 Tech 2, 200 cells (column C)Tech 2, 200 cells (column

6. Calculate an average manual count for both the negative and positive control sample (D and Tech 2, 200 cells (column H)).

7. Calculate the difference between the LH 700 Series NRBC and the manual count (E and J).

Negative Control Positive Control

8. Perform this procedure for 30 days to establish the expected range for the positive control for your laboratory. At the end of 30 days, calculate the mean difference and expected ranges for the positive control as indicated in the table (K through N). Beckman Coulter suggests using the following range as a guideline until your own expected range can be established:

Minimum Difference -12.8 Maximum Difference 12.8

9. Use the following guidelines for results that indicate an ‘out of control situation’. a. Negative control: Differences exceed 2. b. Positive control: Differences exceed the established range. c. Differences exhibit a trend or shift. d. Excessive differences between results might be attributable to variability between

slide readers.

10. Use bias plots to visualize results by plotting the average manual counts on the abscissa (X) and differences on the ordinate axis (Y). For the negative control, plot D on the X axis and E on the Y axis. For the positive control, plot I on the X axis and J on the Y axis.

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EXTENDED QC

3.4 EXTENDED QC

Overview

Extended QC Rules are derived from the German Quality Control Guidelines for the Medical laboratory, known in Germany as Rili-BÄK. Rili-BÄK (Guidelines of the Federal Chamber of Physicians), was first published in 1987 and amended in 1990 and 1993 covering clinical chemistry, immunochemistry and other tests, but not hematology. In 2003, the guidelines were extended to include hematology.

User's can enable/disable Extended QC Rules for 5C Cell control.

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EXTENDED QC

Note: Extended QC Rules apply to 5C Cell control runs only. Other manufacturers' quality control products will not perform with the LH 780 Extended QC Rules program. If your laboratory decides to use other manufacturers' control products, you may use manual calculations, other manufacturers' QC programs or certain middleware products for the purpose of extended QC monitoring. Beckman Coulter does not support the use of any such third-party control products or related Quality Control programs. Therefore, validation of non- Beckman Coulter control products and r elated softwar e is solely the r esponsibility of the laboratory.

Extended QC Rules include:

r Random Error - imprecision r Systematic Error - bias r Total Error - inaccuracy

Note: 5C Cell controls are intended for use as a quality control material with assigned values and expected ranges as defined in the Table of Expected Results distributed with each lot of controls. The application of Extended QC Rules on 5C Cell controls does not denote additional product claims; the Extended QC Rules are only an additional quality control tool, such as XB and Xm, which can be used in conjunction with the assigned values and expected ranges or mean to lab target values to monitor the status of your analyzer.

Extended QC - Random Error

Random error is Extended QC’s measurement of imprecision. The method is considered out of control if the CV falls outside the Extended QC Random

Error Limit. r If the control file has an N

> 2 and N < 20, and the CV exceeds the Random Error limit,

the CV value for that parameter is highlighted in yellow in the statistics section of the QC summary results screen.

r If the control file has an N

> 20, and the CV exceeds the Random Error limit, the CV

value for that parameter is highlighted in red in the statistics section of the QC summary results screen. The user must acknowledge the alert, an d the event is logged in the QC Event log.

Extended QC- Systematic Error

Systematic error is Extended QC’s measurement of bias. A systematic error is defined as the deviation of the mean from the targe t value. The method is considered out of control if the deviation falls outside the Extended QC

Systematic Error Limit. r If the control file has an N

100) exceeds the Systematic Error limit, the Delta Diff for the parameter is highlighted in yellow in the statistics section of the QC summary results screen.

> 2 and N < 20, and the ((absolute Delta Diff / T ar get Value) x

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r If the control file has an N

> 20, and the ((absolute Delta Diff / Target Value) x 100)

exceeds the Systematic Error limit, the Delta Diff for the parameter is highlighted in red in the statistics section of the QC summary results screen. The user must acknowledge

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EXTENDED QC

the alert, and the event is logged on the QC Event log.

Extended QC- Total Error

Total Error is Extended QC’s measurement of inaccuracy, as compared to an established limit. Total Error is defined as the deviation of a single measurement from the Target V alue that was

setup for your 5C Cell control (e.g. BCI Assigned Value or Mean => Lab Target value). For each 5C Cell control run, the WBC, RBC, Hgb, HCT and Plt values are evaluated as

follows:

Target Value +/- (Target Value * Total Error Limit / 100) for that parameter.

If the result is outside of the upper or lower range, the user is notified by highlighting the result in yellow.

Extended QC Limits

Limits are not lot specific. Limits apply to all controls and all control levels except for platelets, for which there are tiered level limits.

Error Limits:

Random Error

Parameter WBC 4.0 5.0 13.0

RBC 2.5 3.0 8.0 Hgb 2.0 2.0 6.0 Hct 3.0 3.0 9.0 Plt

40,000 – 300,000 (Normal, Abnormal II)

Plt

> 300,000 (Abnormal I)

Limit%

9.0 9.0 27.0

6.0 5.0 17.0

Systematic Error Limit%

Total Error Limit%

For Platelets there are two limit sets:

1. 1. Plt values in the range 40 - 300 x 103/µL are evaluated using 5C Normal and Abnormal II level limits.

2. 2. Plt values >300 x 103/µL – are evaluated using 5C Abnormal I level limits.

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Extended QC limits may be edited.

r Editing is restricted to Advance Operator level and above. r Edits are recorded in the QC Event Log.

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QUALITY CONTROL

XB ANALYSIS

3.5 XB ANALYSIS

Overview

XB Analysis is a quality-control method that monitors instrument performance (calibration) by tracking the MCV, MCH, and MCHC parameters of all patient samples. For more information about XB Analysis, refer to the XB Analysis topic in the Reference Information section of the Help.

Using XB

When using XB Analysis, it is important to process samples randomly; for example, chemotherapy or neonate patient samples, if processed as a group, can cause XB to be OUT.

When XB Analysis is on, the Workstation compares the mean values with the target values and the percent limits. If the mean values are within the percent limits of the target values, then the XB is IN.

Setup Options

When you set up XB Analysis, you have options: r You can specify that yo u wan t XB to automatically stop processing on an instrument.

Otherwise, XB status appears in the XB history log, and it is up to you to investigate it. You should investigate any batch that is out of the XB limits.

r You can specify if you want to automatically print XB Analysis information.

Reviewing XB Analysis Information

The W orkstation displays the batch means for each parameter in graph form. The lines on the graph are from point to point, but when printed on the Graphic Printer, a horizontal bar represents each mean.

The Workstation determines if results should be included in a batch by considering several factors. The following factors cause results to be excluded from a batch:

r No CBC Data r Blood detector off r RBC value < 1.0 x 10

cell/µL

r Partial Aspiration r Body Fluid r Non-numeric value for MCV, MCH, and MCHC

You can delete individual samples from the batch. The total number of deletes in a batch must not exceed 5.

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Reviewing XB Results

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the XB window.

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Xm Analysis Overview

3. Select:

This To Display This

Current XB batch results and statistics

XB batch results and statistic s of the batch immediately prior to the current batch.

XB batch results and statistics of the batch previous to the last batch.

XB batch means and statistics.

Add Comments to an XB batch.

The window refreshes the results table, statistics and graphs based on the changes you made

Adding Comments to an XB Batch

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the XB window. Note: You cannot add comments to a current XB Batch you can only add comments to

the last batch or a previous batch

3. To display XB Batch results:

a. Select to display the last batch

b. Select to display a previous batch

4. Select to add a comment.

5. Type the comment you want to add.

6. Select on the Comment window to save Comment.The Workstation adds the comment to the appropriate XB Batch and places an X in the CMNT field.

3.6 Xm Analysis Overview

Overview

Xm Analysis is a quality-control method that uses an Exponentially Weighted Moving Average (EWMA) of CBC, Diff, NRBC and Reticulocyte parameters and compares them with

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Xm Analysis Overview

known target values, to monitor instrument performance. For more information about Xm Analysis, refer to Setting Up Xm Analysis.

Setup Options

When you set up Xm Analysis, you have the following options: r You can specify that you wan t Xm to automatically stop processing on an instrument.

Otherwise, Xm status appears in the Xm history log, and it is up to you to investigate it. You should investigate any batch that is out of the Xm limits.

r You can also specify if you want to automatically print Xm Analysis information.

Parameter Groups

There are four Xm parameter groups:

r CBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT. RDW, RDW-SD and MPV r DIFF (LYMPH%, MONO%, NEUT%, EO%, BA%, NRBC%, LYMPH#, MONO#, NEUT#,

EO#, BA#, and NRBC#)

r RETIC (RETIC%, IRF and MRV) r RETIC Calc (This field displays the RETIC# and Retic calculated parameters that require

a simultaneous CBC analysis)

Note: The workstation does not include runs with a:

r Non-numerical value r Partial Aspiration r RBC value < 1.0 x 106 cell/µL r WBC value < 1.0 x 103 cell/µL r PLT value < 20 x 103 cell/µL r Over linearity "+" r System Alarms

Batch Sizes

Users can configure independent batch sizes for each of the four parameter groups. The batch size can be from 2-1000, inclusive, with a maximum of 20 batches.

Target Value

You can configure the target value for each parameter by:

r Manually entering the target value r Providing a Moving Target equal to the last batch mean. The target shall be updated at

the end of each batch. You can set/lock the last batch mean.

Note: if the target value for a parameter is not defined (blank), or if the target value exceeds the error limits, there will be no graph for that parameter.

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Limits

You can specify each parameter's limit in Absolute value (Upper and Lower limits) format

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Xm Analysis Overview

You can configure the limit for each parameter by:

r Manually entering a limit r Automatically calculating a limit.

r You can specify 2SD or 3SD limits as a deviation from target. r The limits are updated once a batch is completed. You can set/lock the last batch

limit.

Error Handling

You can specify that you want Xm to automatically stop processing on an instrument when the Xm batch mean is out of limits.

You can set Logging/Auto-Stop options:

r 1 Batch Out of limits r 2 Batches Out of limits r When one or two Xm batches are out of limits, depending on your configuration, a

message is logged in the Xm history log.

Reviewing Xm Analysis Information

The ability to view batch means in a graphical and tabular format is provided.

r You can delete the last batch or all batches. r You can add comments to a completed batch r You can delete individual samples from the batch. The total number of deletions in a

batch must not exceed 25% of the total batch. r For example: A batch size of 1,000 would allow for the deletion of up to 250

individual samples.

r The following table identifies the number of samples allowed for deletion from

batches of 20 or less:

Number of samples

Batch Size

20 5

16-19 4 12-15 3

8-11 2

4-7 1 2-3 0

allowed for deletion

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Xm Analysis Overview

Reporting

Auto-Print Reports

You can auto-print batch mean summary report (graphical and tabular) with the following options:

r Every 20 batches r If batch is out of limits

Upon Demand Reports

The following reports can be printed at your request:

r Batch means summary (graphical and tabular) r Batch runs

Exporting

You can also export Batch means and runs to CSV format.

Reviewing XM Results

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the Xm window.

3. Select:

This To Display This

Current Xm batch results and statistics

Xm batch results and statistics of the batch immediately prior to the current batch (last batch).

Xm batch results and statistics of the batch previous to the last batch (previous batch).

Batch Means Table

Batch Means Graph

Add Comments to an Xm batch.

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Note: You cannot add comments to a current Xm Batch, you can only add comments to the last batch or a previous batch.

The window refreshes the Xm Statistics Table, Xm Means T able and XM Means Graphs based on the changes you made.

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PARTICIPATING IN IQAP

Adding Comments to an Xm Batch

1. Select on the Command Center to display the Quality Assurance application.

2. Select to display the XM window. Note: You cannot add comments to a current Xm Batch; you can only add comments to

completed batches (any older batch in the Batch Means screen).

3. To display Xm Batch results:

a. Select to display the last batch.

b. Select to display a previous batch.

4. Select to add a comment

5. Type the comment you want to add.

6. Select on the Comment window to save the comment. The Workstation adds the comment to the appropriate Xm Batch and places an X in the CMNT field.

3.7 PARTICIPATING IN IQAP

Use this procedure to download control folder data from the LH Workstation to your removable media for submission to the Beckman Coulter Interlaboratory Quality Assurance Program (IQAP).

You will be supplied with self-adhesive return labels and pre-addressed mailers. Control data should be submitted to IQAP on a monthly basis as soon as you have finished using a set of controls.

IQAP Setup

An IQAP participant number is assigned to you at the time you enroll in the program. This participant number identifies your data set from all others. Ensure that your IQAP participant number has been entered in your Workstation prior to downloading your data to diskette. You may also choose to participate in eIQAP.

IQAP Download Procedure

At the LH Workstation:

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1. Select on the Command Center.

2. Select to display the CONTROLS window.

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QUALITY CONTROL

PARTICIPATING IN eIQAP

3. Select . An IQAP Disk Storage window appears.

4. Ensure the removable media (formatted CD, formatted diskette, flash drive) is inserted in the appropriate drive or attached to the computer.

5. Select the lot numbers you want copied to the removable media.

6. Select to begin copying the control information.

7. The “Save as” window appears.

8. Specify the location of your removable media and select “Save”.

9. After the download process is complete, take the removable media from the appropriate drive or USB location.

10. Use the files downloaded to submit the data through the eIQAP website.

Troubleshooting

If there is a problem downloading QC data to your chosen remova ble media chec k the following:

r If using a diskette, make sure the diskette is inserted completely in the a: drive. r If you are using a blank diskette, make sure it has been formatted. r If using a CD, make sure it is the CD-R type and that it is formatted. r If using a flash drive, be sure to remove it properly. Double click on the "Safely Remove

Hardware" icon on the task bar and follow the on screen directions to remove.

If all attempts to download are unsuccessful you can submit your control data to IQAP using the Summary Data Entry Form or the COULTER Retic-C Control Data Entry Form. Refer to the Data Entry chapter of the Interlaboratory Quality Assurance Program Procedure Manual for specific instructions.

3.8 PARTICIPATING IN eIQAP

Once you have your IQAP participant number, you may elect to set up an eIQAP internet account through our secure server. Your eIQAP participant account is accessible through the User Name and Password that you setup. The account provides separate administrator and user functions. After enrollment, all eligible hematology instruments in your laboratory will be accessible through your eIQAP account. eIQAP allows you to upload your data via the Internet and to access your own IQAP reports.

Enroll in eIQAP

1. Go to the company's website at: www.beckmancoulter.com.

2. Select Customer Support from the top menu, then select QA & Service Programs.

3. Scroll down to the Interlaboratory Quality Assurance Program and select the link "Go to eIQAP"

4. You will find information and help in registering your account.

3-22

Data Submission for eIQAP

Data is uploaded to your eIQAP account from either a:

PN 773022BE

QUALITY CONTROL

PARTICIPATING IN eIQAP

r 3.5 inch diskette r CD-ROM, or r flash drive.

Follow instruction on the eIQAP site to upload data. Use a CD or flash drive for the eIQAP upload if the computer you use does not have a 3.5 inch floppy drive.

PN 773022BE

3-23

QUALITY CONTROL

PARTICIPATING IN eIQAP

3-24

PN 773022BE

4.1 COLLECTING WHOLE BLOOD SPECIMENS

Collect whole blood in a salt of EDTA according to tube manufacturer's instructions and procedures in:

1, 2, 3

RUN SAMPLES

r CLSI publication H4-A3 (for capillary) r CLSI publication H3-A3 (for venipuncture) 5.

Beckman Coulter recommends you use a dipotassium (K2) or tripotassium (K3) salt of EDTA.

IMPORTANT Misleading results could occur if you fail to leave space at the top of the tube between the

sample and the stopper. Ensure you leave space at the top of the tube between the sample and the stopper to facilitate mixing. Also, ensure that the sample is properly mixed before analysis.

Follow manufacturer's recommendations for use of microcollection and venipuncture devices.

For Automatic aspiration mode, you need at least 1.0 mL of sample with pr oper propor tion of blood to anticoagulant.

For LH 700 Series only systems, the instrument aspirates a maximum of 300 µL (0.3 mL) of whole blood. In the Automatic aspiration mode, the instrument aspirates approximately 200 µL (0.2 mL) of whole blood for the Manual aspiration mode.

For LH 700 Series SlideMaker systems, the instrument will aspirate an additional 250 µL (0.25 mL) of whole blood for the SlideMaker. A total of 550 µL (0.55 mL) will be aspirated.

4.2 STORING SPECIMENS

Analyze specimens as soon as possible for optimum accuracy.

PN 773022BD

Venipuncture Specimens

For CBC and DIFF:

r Run within 24 hours after collection, if stored at 21.2 to 25.6 °C (70 - 78 °F). r Run within 48 hours after collection, if stored at 2 to 8°C (35.6 to 46.4°F).

For Reticulocytes:

r Run within 24 hours after collection, if stored at 21.2 to 25.6 °C (70 - 78 °F). r Run within 72 hours after collection, if stored at 2 to 8°C (35.6 to 46.4°F).

NRBC Parameters

r Run within 24 hours after collection, if stored at 21.2 to 25.6 °C (70 - 78 °F). r Stored between 2 and 8°C (35.6 and 46.4°F), up to 24 hours after collection.

Note: Also refer to any pertinent manufacturer's storage recommendations for the venipuncture and microcollection devices used in your lab.

4-1

RUN SAMPLES

IDENTIFYING SAMPLES OVERVIEW

4.3 IDENTIFYING SAMPLES OVERVIEW

Automatic Aspiration Mode

The Workstation identifies a sample by:

r Reading the cassette number and cassette position of each sample at the time it is cycled r Reading the tube’s bar-code label automatically r Allowing you to provide sample demographic information that includes optional

identifiers, such as a patient identifier

r Time-stamping sample results with the date and time they were analyzed.

Manual Aspiration Mode

The Workstation identifies a sample by:

r Reading the tube’s bar-code label when you use the handheld scanner r Reading a sample identifier you provided by using the Numeric Keypad r Allowing you to provide sample demographic information that includes optional

identifiers, such as a patient identifier

r Time-stamping sample results with the date and time they were analyzed.

Using the Predilute Mode

Overview

The Predilute mode on the LH 700 Series may be used to analyze diluted specimens that exceed the reportable range, or to run a citrated tube when clumped platelets are suspected. The Predilute mode runs in the CBC test mode via manual aspiration.

You may enter dilution factors from 1.1 to 5.0. Use adequate sample and diluent volumes to prepare a simple dilution. Manual mode requires 200 mL of sample for aspiration.

A simple dilution is one in which a unit of sample volume is combined with the appropriate unit volume of diluent to achieve a desired concentration. The dilution factor is the total number of unit volumes in which the blood sample will be dissolved. For example, a 1:2 dilution combines one (1) unit volume of blood sample and one (1) unit volume of diluent. The resulting dilution factor is two (2 = 1 + 1).The diluted sample results are automatically multiplied by the dilution factor entered.

Procedure for a 1:2 Dilution

Use a sample for which you already have results.

4-2

1. Dispense diluent from the instrument, using the function. Have a clean empty tube ready to collect the diluent dispensed (approximately 2 mL) from the manual

probe when you press .

PN 773022BD

RUN SAMPLES

IDENTIFYING SAMPLES OVERVIEW

2. Using a pipette, dispense 200 µL blood into a second clean tube which does not contain any anticoagulant.

3. Use a pipette to dispense 200 µL diluent into the same (second) tube.

4. Mix well.

5. On the Workstation Command Center: a. Enable Predilute (CBC).

b. Set the Factor to 2.0 in the pop-up box.

Note: A dilution factor is valid for one sample analysis. Once the sample has been processed, the Analyzer disables the Predilute function and the dilution factor returns to a default of 1.0.

6. Identify your sample ID using the numeric keypad or bar-code scanner.

7. Analyze your sample using the manual mode, as soon as possible after preparing the dilution.

Note: If results are not received at the Workstation within approximately two minutes, the predilute function is disabled.

8. Compare the results to the results of the sample analyzed undiluted.

Note: If the Pre-dilute mode is chosen and then a cassette is introduced into the Automatic Mode, the sample in the cassette will be aspirated. The Analyzer will then stop and discard the sample. No results are sent to the Workstation. No error message will be displayed at the workstation.

Setting Up Identifiers

As part of system setup, you must specify whether your laboratory wants the cassette number and position, the tube’s bar-code label, or both used as a positive identifier. When you specify a positive identifier, the system links it irrevocably to the date and time of instrument analysis.

If you specify cassette number and position, ensure you provide enough demographic information or use another identifier, such as the sample identifier, to distinguish sample results since you may use a cassette number and position more than once throughout the day.

Tube Sizes

Beckman Coulter does not recommend the use of one tube in preference to another, nor guarantees the acceptability of the sample tube to produce quality results. Refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com.

Keep the following in mind when using this list:

PN 773022BD

r Use the tubes listed only with the cassette indicated. r 13-mm cassettes are also known as 5-mL cassettes. r 16-mm cassettes are also known as 7-mL cassettes.

4-3

RUN SAMPLES

IDENTIFYING SAMPLES OVERVIEW

r HEMOGARD cassettes are those designed for tubes with HEMOGARD closure.

CAUTION Possible system damage could occur if the adapters for the Beckman Coulter

MAXM, MAXM with Autoloaders, JT2 and JT# analyzers are used for the LH700 Series. Do not use these adapters on the LH 700 Series.

r Two sizes (2 ML and 3mL) of sleeve adapters are available to accommodate narrow and

short tubes. Place the tube inside the adapter before placing it into a 13-mm cassette.

Table 4.1

Sleeve Adapter Solid Base Length

2 mL 1 inch 3 mL 1/2 inch

Universal Tube Processing

The LH 700 Series System contains a universal stripper plate. It permits the instrument to run multiple tube sizes and styles in Automatic Aspiration Mode. Refer to the Hematology Tube List available on the BCI website at www.beckmancoulter.com.

CAUTION Possible specimen leakage or clogging of the aspiration system can occur. Excessive piercing of

the sample tubes causes significant coring of the stopper . The number of pierces without problems can vary slightly among sample tube types and manufacturers. Do not pierce a blood collection tube more than five times.

Your instrument also contains a self-adjusting tube detector. This tube detector automatically adjusts to various sizes of tubes in the same cassette. You do not need to manually change the instrument tube detector settings.

Many laboratories run tubes that do not require adapters or clips on the LH 700 Series; however, your laboratory may require tube adapters or cassette clips.

If your laboratory requires adapters or clips, contact your Beckman Coulter representative.

4-4

PN 773022BD

4.4 USING BAR-CODE LABELS

Beckman Coulter recommends the use of bar-code labels for specimen identification.

RUN SAMPLES

USING BAR-CODE LABELS

The LH 700 Series System comes with cassette and cassette position numbers 1 to 100. You can obtain additional cassettes with numbers

L a b e l

a l i g n m e n t

m a r k e r

C a s s e t t e

a l i g n m e n t

m a r k e r

101 to 1000 from Beckman Coulter Inc.

C a s s e t t e b a r - c o d e

l a b e l

Two labels provide identification: r Cassette ID label provides a

4-digit cassette number.

r Cassette bar-code label appears

as a bar-code and readable number. The cassette bar-code label includes the cassette ID number and the 2-digit position number.

C a s s e t t e I D l a b e l

T h e c a s s e t t e b a r c o d e l a b e l s h o u l d b e p o s i t i o n e d t o t h e r e a r o f t h e c u t o u t a n d c e n t e r e d l e f t t o r i g h t

Specimen tube bar-code labels pr ovide sample identification. Bar -code label specifications are in the Reference Information section of this help system.

If you use Interleaved 2-of-5 bar-code specimen labels, you must set the number of digits on the label in the Analyzer.

Labeling Requirements—Tubes Without Adapters or Clips

IMPORTANT

labels could keep the instrument from reading the bar -cod e labels. Ensure the bar -c ode labels are undama ged. Ensure the bar-code labels conform to the specifications provided in Chapter 4 of th e Reference manual.

Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code

C o r r e c t

I n c o r r e c t

You can use up to two labels in addition to the sample tube manufacturer's label.

S t o p p e r

B a r s p a r a l l e l t o s t o p p e r

> 1 2

B a r s n o t p a r a l l e l t o s t o p p e

Do not skew the bar-code label mor e than 12 degrees.

Place each label so that it does not cover the bottom of the tube and is flat and smooth against the tube. This prevents the adapter from being broken or the tube jammed, and ensures the label can be scanned properly.

Ensure that the bar-code symbol and a 1/4-inch blank space on either side of the bar-code symbol ar e visible to the scanner.

PN 773022BD

4-5

RUN SAMPLES

USING BAR-CODE LABELS

For tubes with rubber-stopper caps or foil tops:

1. Place the bar-code label so that the first bar of the bar-code symbol is at least 1/2 inch from the tube cap.

2. Press the label down securely, including edges and corners.

3. Ensure the bars on the label are parallel to the stopper.

For all other tubes:

Place the bar-code label so that the first bar of the bar-code symbol is at least 1/4 inch from the tube cap.

Labeling Requirements—Tubes with Sleeve Adapters

IMPORTANT

labels could keep the instrument from reading the bar-code labels. Ensure the bar-code labels are undamaged. Ensure the bar-code labels conform to the specifications provided in Chapter 4 of the Reference manual.

Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code

C o r r e c t

I n c o r r e c t

Y ou can use a maximum of two labels in addition to the sample tube

S t o p p e r

B a r s p a r a l l e l

t o s t o p p e r

B a r s n o t p a r a l l e l

t o s t o p p e r

manufacturer's label. Place each label so that it does not cover

the bottom of the tube and is flat and smooth against the tube. This prevents the adapter from being broken or the tube jammed, and ensures the label can be scanned properly.

Do not skew the bar-code label more than 5 degrees.

3 mL

Ensure that the bar-code symbol and a 1/4-inch blank space on either side of the bar-code symbol are visible through the read window when you insert the

2 mL

tube into the adapter.

4-6

PN 773022BD

RUN SAMPLES

USING BAR-CODE LABELS

TOP OPENING

You must position the gray sleeve adapters in a cassette so that their keys (located on top of their bar-code read windows) fit into the top openings of the cassette.

READ SLIT

KEY

IMPORTANT Sample misidentification could occur if the label is improperly aligned in the read

window. The bar-code reader can only read the portion of the bar-code label within the read window. Make sure the bar-code label appears within the read window.

Labeling Requirements—Tubes with Cassette Clips

IMPORTANT

Risk of misidentification. Use of poor quality, dirty, improperly placed or damaged bar-code

C o r r e c t

I n c o r r e c t

You can use a maximum of two labels in addition to the sample tube

S t o p p e r

B a r s p a r a l l e l

t o s t o p p e r

1 2

B a r s n o t p a r a l l e l

t o s t o p p e r

manufacturer’s label. Do not skew the bar-code label more

than 12 degrees. Ensure that the bar -code symbol and a

1/4-inch blank space on either side of the symbol are visible to the scanner.

Place labels flush with the tube cap. Place each label so that it does not cover the bottom of the tube and is flat and smooth against the tube. This prevents the adapter from being broken or the tube jammed, and ensures the label can be scanned properly

PN 773022BD

4-7

RUN SAMPLES

CASSETTE HANDLING

4.5 CASSETTE HANDLING

Make sure the bar-code label faces up when you place a tube into the cassette so that it may be scanned correctly.

SPECIAL CASSETT CLIP

The cassette is the carrier for the sample tubes (patient, control, or special test) used in Automatic aspiration mode where automatic

L a b e l

a l i g n m e n t

m a r k e r

C a s s e t t e

a l i g n m e n t

m a r k e r

loading, mixing, and sampling occurs.

C a s s e t t e b a r - c o d e

l a b e l

Tubes should be pushed into the cassette with the tube bar-code labels facing up.

Always hold the cassette firmly by its edges. Do not try to hold or lift a cassette by grabbing a tube. The weight of the remaining tubes could cause the cassette to fall.

C a s s e t t e I D l a b e l

T h e c a s s e t t e b a r c o d e l a b e l s h o u l d b e p o s i t i o n e d t o t h e r e a r o f t h e c u t o u t a n d c e n t e r e d l e f t t o r i g h t

Cleaning the Cassette

Wash the cassettes as needed in warm soapy water and rinse thoroughly. Do not use an abrasive. Keep the cassettes free of dried blood, bleach, or diluent. Be careful not to scratch or deface the bar-code labels. Dirt, smears, pencil lead, and grease can affect bar-code label reading.

4-8

PN 773022BD

4.6 LOADING THE CASSETTE

RUN SAMPLES

LOADING THE CASSETTE

WARNING

force a tube into a cassette. If a tube should break, use your laboratory’s safety procedure for cleaning the broken glass.

IMPORTANT Sample misiden tificatio n could occur. If not using the appropriate bar-code labels on the

sample tubes, ensure you place the tubes in the proper cassette positions.

Risk of personal injury. Forcing a tube into the cassette improperly could cause it to break. Do not

1. Slide each sample firmly into the cassette.

2. Ensure the bar-codes are facing up. Note: If the compressor has timed out and a cassette is placed in the loading bay, the

SlideMaker will not automatically start.

PRIME

APERT

Before placing a cassette in the loading bay, press to place the system in a READY state. Once READY appears on the Numeric Keypad, the cassette can be placed in the loading bay and processed as normal.

Using Cassette Clips

Make sure the bar-code label faces up when you place a tube into the cassette so that it can be scanned correctly.

SPECIAL CASSETT CLIP

PN 773022BD

4-9

RUN SAMPLES

LOADING THE CASSETTE

Installing the Cassette Clips

Install the cassette clips into the HEMOGARD cassettes for tubes with HEMOGARD Closure. You can use any of the tubes approved for this cassette with these cassette clips in place.

1. Place the bottom of the cassette clip into the opening of the cassette.

2. Pressing down on the cassette clip, turn it to the left (counterclockwise) until it clicks into place. Then push down on the cassette clip to position it at the bottom of the cassette opening.

3. It is easiest to insert the first cassette clip into the far left opening of the cassette (cassette position one). Then proceed in order from left to right.

4. Install cassette clips into all 12 tube openings of each HEMOGARD cassette for tubes with HEMOGARD Closure.

4-10

PN 773022BD

4.7 USING HANDHELD SCANNER

IMPORTANT

1. Risk of sample misidentification. When using the handheld scanner, occasional misread errors can occur as the result of partial label scans and damaged or misapplied labels. Beckman Coulter recommends that you verify each bar-code reading to assure correct patient identification.

2. DO NOT use the following characters # @ [ \ ] ` { | } ~ in Specimen or Patient identifiers. There is a potential for Specimen or Patient misidentification to occur. The system will substitute or omit these characters when the system is configured in a language other than English or Chinese.

3. DO NOT use leading or trailing spaces in the ID.

1. Ensure the cursor is in the field you want to fill with the scanned information.

RUN SAMPLES

USING HANDHELD SCANNER

WARNING Risk of personal injury. Some

handheld scanners use a low-power, visible laser diode which could damage your eye. Avoid staring directly into the beam.

2. Aim the scanner at the bar-code and press the trigger . If necessary, adjust the scanner position so the red scan beam is centered on the bar-code and overlaps it on both sides.

3. When the scanner has read the symbol, you will hear a beep. If you do not hear a beep:

r Ensure the scanner is properly

connected to your Workstation.

r Make sure the scanner is

properly configured for your labels.

4. Press to accept the sample ID at the Workstation.

PN 773022BD

IMPORTANT

of data entry in the Bar-code ID field, the sample ID provided is cleared. This minimizes the risk of sample misidentification.

Risk of missing identifier. If you fail to send the sample ID to the instrument within 60 seconds

5. Press , then to send the sample ID to the Analyzer.

4-11

RUN SAMPLES

USING HANDHELD SCANNER

6. After the sample ID appears on the Analyzer. Press to accept the sample ID or

STOP

to reject the sample ID.

7. Ensure the sample ID is correctly displayed at the Analyzer screen.

Cleaning the Scan Window

Note: The following information is reprinted from the Welch Allyn IT 3800/3900 Handheld Linear Imager User's Guide by by permission of Welch Allyn, Inc.

CAUTION Risk of damage to the handheld scanner. Do not submerge the scanner in water. The scanner’s

housing is not water tight. Do not use abrasive wipers or tissues on the scan window: abrasive wipers may scratch the window. Never use solvents (alcohol or acetone) on the housing or window: solvents can damage the finish or the window.

E N T E R

Scanning performance can degrade if the scan window is not clean. If the scan window is visibly dirty, or if the scanner is not scanning well, clean the scan window with a soft cloth or tissue dampened with water (or a mild detergent-water solution). If a detergent solution is used, rinse with a clean tissue dampened with water only.

The scanner housing can also be cleaned the same way.

Setting Up Bar-Code Configuration

Note: Use this procedur e to indicate the number of digits only when you use Interleaved 2-of-5 bar-code labels for sample tubes.

1. Go to the Analyzer screen.

2. Press

3. Press

4. Press

5. Go to the Numeric Keypad. It displays VALUE? XXXX

6. Use the Keypad to specify the number of digits (from 03 through 11).

7. Press after specifying the number of digits.

8. Go to the Analyzer screen.

9. Confirm the number you specified appears on the Analyzer screen.

MAIN MENU. SYSTEM CONFIGURATION.

NUMBER OF BAR-CODE DIGITS (2 OF 5) XX, where XX repr esents the current number of

bar-code digits.

E N T E R

4-12

PN 773022BD

CYCLING SAMPLES IN AUTOMATIC ASPIRATION MODE

10. Press one of the following:

SYSTEM RUN To cycle samples. RETURN To display the Analyzer MAIN MENU screen.

4.8 CYCLING SAMPLES IN AUTOMATIC ASPIRATION MODE

WARNING Risk of personal injury. If a problem occurs while the system is cycling, press and wait

for the system to stop before you do anything to correct the problem. Attempting to correct an instrument problem while the instrument continues to process samples could injure you.

1. Ensure the instrument is set up for the appropriate test.

IMPORTANT Misleading results can occur if specimens contain clots. Inspect specimens for clots and use

good laboratory practices for verifying results to ensure you do not receive misleading results.

2. Ensure your specimens have been collected, stored, and mixed properly.

3. Load the cassettes.

4. Place the cassettes firmly and securely into the loading bay on the right side of the Diluter. The instrument automatically begins cycling the cassettes.

5. After the instrument cycles the samples, review the sample results on the Workstation.

RUN SAMPLES

STOP

4.9 CYCLING SAMPLES IN MANUAL ASPIRATION MODE

IMPORT ANT If the probe is stuck in the IN position after you entered the patient ID, you can discard that ID

only by resetting the Analyzer.

1. Ensure the instrument is set up for the appropriate test.

IMPORTANT Misleading results can occur if specimens contain clots. Inspect specimens for clots and use

good laboratory practices for verifying results to ensure you do not receive misleading results.

2. Ensure your specimens have been collected, stored, and mixed properly.

3. You can enter the sample ID for Manual Aspiration three ways, by performing the steps below:

To type the sample ID using only the Numeric Keypad at the instrument:

a. Press . b. Type sample ID.

E N T E

c. Press .

PN 773022BD

4-13

RUN SAMPLES

CYCLING SAMPLES IN MANUAL ASPIRATION MODE

d. Ensure the sample ID is displayed correctly at the Analyzer screen. e. If you need to change the ID, go back to step a.

To scan the sample ID into the Barcode field at the Workstation

At the Workstation: a. Place the cursor in the barcode field. b. Scan the sample ID using the handheld scanner.

IMPORTANT Risk of missing identifier. Prior to accepting the sample ID at the Workstation, verify that the

scanned ID matches the bar-code label. This minimizes the risk of sample misidentification.

c. Press to accept the sample ID at the Workstation.

At the Analyzer’s Numeric Keypad:

d. Press then (period or decimal point).

T E

e. Press to accept or to reject the sample ID. f. If you need to change the ID, go back to step a.

To type the sample ID at the Workstation

At the Workstation: a. Type the sample ID for the next sample to be cycled into the barcode field

b. Press to accept the sample ID at the Workstation.

At the Analyzer’s Numeric Keypad:

c. Press then (period or de cimal point) .

T E

d. Press to accept or to reject the sample ID. e. If you need to change the ID, go back to step a.

4-14

PN 773022BD

CHANGING THE NUMBER OF ASPIRATIONS PER TUBE

4. Aspirate the sample.

IMPORTANT Risk of missing identifier. If you fail to send the sample ID to the instrument within 60 sec-

onds of data entry in the Bar-Code ID field, the sample ID is cleared. This minimizes the risk of sample misidentification.

5. Immerse the aspirator tip in the tube. The instrument automatically aspirates the sample.

6. When you hear a beep, remove the tube from the aspirator tip. The probe cleaner retracts the aspirator and automatically cleans it.

7. After the instrument cycles the samples, review the sample results on the Workstation.

4.10 CHANGING THE NUMBER OF ASPIRATIONS PER TUBE

CAUTION Needle damage can occur if you pierce a specimen more than five times. Do not pierce a

specimen tube more than five times.

1. Go to the Analyzer screen.

RUN SAMPLES

2. If the

3. Press

4. Press

SYSTEM RUN screen currently appears on the Analyzer screen, skip to step 4.

Otherwise, press

SYSTEM RUN. ASPIRATIONS/TUBE.

MAIN MENU.

5. Go to the Numeric Keypad.

6. Use the Keypad to specify the number of aspirations desired.

E N T E R

7. Press after specifying the number of aspirations.

8. Go to the Analyzer screen to verify that the number of aspirations appears on the Analyzer.

SYSTEM RUN

The

screen displays the current number of aspirations. Example:

ASPIRATIONS/TUBE 01

4.11 CHANGING TEST MODE

1. Go to the Command Center.

2. Use to select the default test type for sample processing.

PN 773022BD

CDR Run samples for CBC, Diff and Retic. CD Run samples for CBC and Diff. C Run samples for CBC only. CR Run samples for CBC and Retic. R Run samples for Retic only.

The CURRENT MODE message displays the test mode you select.

4-15

RUN SAMPLES

ENABLING/DISABLING BLOOD DETECTOR

Note: If Random Access is enabled, review Random Access Overview, Heading 7.7.

4.12 ENABLING/DISABLING BLOOD DETECTOR

1. Go to the Analyzer screen.

2. Press

3. Press

4. Press BLOOD DETECTOR until the appropriate s etting appears.

5. Press one of the following:

MAIN MENU. SYSTEM CONFIGURATION.

Note: The system flags all parameters with a P (partial aspiration) when samples are analyzed with blood detectors disabled. P flagged control run results are automatically removed from statistical calculations, and there is no way to reintr oduce the flagged runs into the calculations.

SYSTEM RUN RETURN

To cycle samples. To display the Analyzer MAIN MENU screen.

4-16

PN 773022BD

5.1 REVIEWING SAMPLE RESULTS

1. Select on the Command Center to display the Patient Tests application.

2. If necessary, select to display the Results & Graphics window that contains:

r Parameters r Flags r Codes r Definitive messages r Suspect messages r Histograms r DataPlots r Identification information.

3. If necessary, find the sample results you want to review.

4. Specify the way you want the window updated:

REVIEWING DATA

Keeps the current sample displayed. You can view the graphs, demographics and detailed p ar ame ter results for the sample results as needed.

The W orkstation continues to receive, process and store analysis data from the Analyzer.

Automatically updates the window as the Workstation receives patient sample analysis data from the Analyzer.

5.2 Results & Graphics Overview Tab

The Results and Graphics Overview Tab allows you to view results and graphics for patient tests. It displays the information identified in the following sections.

r Identification Information r Parameters r Suspect/Definitive r WBC and RBC DataPlots r Histograms r Rule Messages

Identification Information

The patient identification information includes the Patient ID, First Name, Last Name and Sequence Number as well as:

PN 773022BD

r Sample ID r Cass / Pos r Date

5-1

REVIEWING DATA

Results & Graphics Overview Tab

r Time r Aspiration Mode r Status r Instrument r Listname r Elapsed Time

Parameters

WBC UWBC RBC RET% NE% NE# HGB RET# LY% LY# HCT MRV MO% MO# MCV IRF EO% EO# MCH BA% BA MCHC

RDW RDW-SD

NRBC% NRBC# PLT MPV

Suspect/Definitive

This field identifies suspect and definitive messages associated with the sample result. Suspect messages appear for sample results based on an abnormal cell distribution or

population. The system generates these messages according to an internal algorithm. All sample results with suspect messages automatically appear in the Review Folder.

Definitive messages appear for sample results based on action limits your laboratory defines. The messages are set up as part of your flagging limits.

Review the sample according to your laboratory’s procedures.

WBC and RBC DataPlots

Select the WBC or RBC tab to view the respective DataPlots. DataPlots present a combined view of subp opulation density and membership.

Histograms

Histograms provide a graphical representation of the cell frequency versus size. The histograms (WBC, RBC and PLT) display the data from the average of the apertures.

5-2

Double-click a histogram to view an enlarged version.

Rule Messages

After processing a sample, this field displays rule messages that apply to the sample.

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5.3 REVIEWING 2D DATAPLOTS

By default, DataPlots prese nt a combined vie w of population density and membership. Colors represent different types of cells. Shades of colors represent the number of cells—bright colors being the most dense.

Button Population Color Button Population Color

Lymphocytes Blue RBCs Red

Neutrophils Purple Reticulocytes Blue

Eosinophils Orange

Monocytes Green Platelets Green

Basophils White WBCs Purple

REVIEWING DATA

REVIEWING 2D DATAPLOTS

Non-white cells Red

The Y-axis represents volume, and the X-axis represents relative light scatter. If the instrument encounters a clog while analyzing the sample, the appropriate code appears

on this window:

Code Means

FC Flow cell clogged. PC1 Partial clog 1. PC2 Partial clog 2.

Enlarged View

Double-click a DataPlot to see an enlarged version of it. Select to return to the normal size.

Select the parameter button at the top of the enlarged window to remove the corresponding population from the DataPlot.

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Select to display the classic VCS scatterplot (DF1) beside the LH 700 Series DataPlot. You cannot remove populations from the classic scatterplot.

What to Look For

When reviewing DataPlots, inspect:

5-3

REVIEWING DATA

REVIEWING 3D DATAPLOT

r Position of individual populations as compared to normal/typical positions r Amount of separation between populations as compared to normal/typical separation r Relative concentration of each population as compared to normal/typical concentrations r Presence of unexpected or non-typical populations.

Refer to the Reference manual for more information about DataPlot development. Refer to your laboratory’s operating procedures for details about interpreting DataPlots.

5.4 REVIEWING 3D DATAPLOT

Select to display the 3D DataPlot window to review a three-dimensional (3D) representation of the data for a sample. The 3D DataPlot window appears on top of all other windows until you minimize it.

Initially the 3D DataPlot shows the currently selected full data, static information for the sample run. If the Results & Graphics window is unlocked, the 3D DataPlot displays the last sample received.

Select This To Display This

WBC differential data. This button appears gray and inactive when no data is available.

Reticulocyte data. This button appears gray and inactive when no data is available.

The 3D DataPlot presents a combined view of population density and membership. Colors represent different types of cells. Shades of colors represent the number of cells—bright colors being the densest.

Button Population Color Button Population Color

Lymphocytes Blue RBCs Red

Neutrophils Purple Reticulocytes Blue

Eosinophils Orange

Monocytes Green Platelets Green

5-4

Basophils White WBCs Purple

Non-white cells Red

Select a parameter button on the side of the 3D DataPlot window to remove the corresponding population from the 3D DataPlot. The Workstation automatically redraws the

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REVIEWING DATA

REVIEWING HISTOGRAMS

3D DataPlot without the selected population. Select the button a second time to include the corresponding population.

Retrieving Data

You can also view data for results that have previously been saved. By default, the Workstation stores data for the last 2000 samples. You can change the amount of data the Works tation stores as part of setup.

1. Select a sample from the Completed Folder.

2. Select to view the Results & Graphics screen.

3. Select to see a three-dimensional representation of the differential data for the sample selected.

Changing the Perspective

Drag to change the angle of the DataPlot. You can also use and .

Select This To Do This

Rotate the DataPlot.

Play the analysis from beginning to end.

Rewind the analysis to the beginning.

Forward the analysis to the end.

Minimizing the Window

Select to minimize the window.

5.5 REVIEWING HISTOGRAMS

Histograms show relative cell frequency versus size. They provide information about erythrocyte, leukocyte, and thrombocyte frequency. They also might show the presence of subpopulations. Histograms provide a means of comparing the sizes of a patient’s cells with normal populations.

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Double-click a histogram to see an enlarged version of it. Select to r eturn to the normal size.

5-5

REVIEWING DATA

EDITING SAMPLE RESULTS

What to Look For

IMPORTANT Incorrect results can occur if you estimate the number of cells from the distribution curves.

Curves show only the relative, not actual, number of cells in each size range. Do not estimate the number of cells from the distribution curves.

When reviewing histograms, inspect:

Refer to the Reference manual for more information about histograms. Refer to your laboratory’s operating procedures for details about interpreting histograms.

5.6 EDITING SAMPLE RESULTS

1. Select on the Command Center to display the Patient Tests application.

2. Find the results you want to edit.

3. Select to display the Edit Sample window.

4. Edit the following as necessary:

r Preassigned and read identification information r Parameter results r Demographic information

Tab

r Use to move between fields.

Note: Duplicate Sample IDs or Cass/Pos are allowed for the same Patient ID only if the Test Type is different. If the same test type is specified for a Sample ID, the following message will display:

Duplicate Sample ID entry. Sample IDs must be unique within the ToDo list. Original value will be restored.

5. If you want to add a test or remove a

PENDING test:

a. Select the specific test identifiers you want to add or remove. b. Provide the sample identification information for the tests.

IMPORTANT Incorrect results or incorrect identification could lead to misleading results or

misidentification. Before saving edits, check that you typed them properly.

5-6

6. Select to save the edits in the database. The Workstation recalculates any derived parameters and reapplies flagging limits. Decision criteria rules are not reapplied. Reports with Pending status include a special message indicating the status. When all tests complete processing, the report includes a special message that indicates the change in status.

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5.7 REVIEWING PATIENT HISTORY

1. Select on the Command Center to display the Patient Tests application.

2. Find the most recent sample for the patient you want to review.

3. Select to display the Patient History window that contains:

r Patient History Table r Patient History Statistics r Patient History Graphs

5.8 PROCESSING RESULTS OVERVIEW

The Coulter LH 700 Series System provides many functions to help you identify and process results quickly and effect ively. The Workstation includes flags and codes with results to help you. You can also customize the flagging of results and define rules for flagging sample results.

Flagging

The Workstation assigns priorities to flags. Critical flags (cH/cL) are the most important. They are followed by action flags (aH/aL) and then default flags(H/L).

REVIEWING DATA

REVIEWING PATIENT HISTORY

IMPORTANT

the results are manually edited, or when new results are received for a pending sample. Flagging is not reevaluated upon a change of flagging limits for results already in the database. Delta Check and Reflex Decision Rules are not reevaluated.

Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument results. All flagging options include reference ranges (H/L), action and critical limits, definitive flags, suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions.

You can customize many of the flags to suit the needs of your laboratory. You can define:

r Default high/low limits r Different high/low limits based on gender and age r Different high/low limits based on location r Action limits that exceed the default limits. These appear with a unique aH (action high)

and aL (action low) flags

r Critical limits that exceed the action limits. These appear with a unique cH (critical

high) and cL (critical low) flags

r Limits (action) that force the display of definitive messages r Limits that route results to a special Review Folder (Auto Validation).

Of course, you do not need to define these all at once, you can use the default set* and gradually add additional limits based on your laboratory's assessment.

Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when

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*The default set is in alignment with the adult refer ence ranges found in literature.

55, 56, 57, 58,

5-7

REVIEWING DATA

PROCESSING RESULTS OVERVIEW

Rules for Flagging Results (Decision Rules & Criteria)

You can define rules for delta checking. When the Workstation finds a sample for a patient that already has sample results in the DataBase, it uses the rules you define to determine how to flag the sample.

You can also define rules (Reflex Manager) to identify sample results that meet a set of criteria. For example, you can automatically generate the message "Perform Retic Count" in the comment field if the W orkstation receives a sample result with Hgb <= 10.5 or RBC <= 3.2 and MCV <= 65.

As part of your rule definition, you can specify where you want the results that satisfy the rule to appear. For example, the Workstation can route results to special Reflex Manager, Delta Check and Review folders.

Processing Flagging Limits

The following flow chart illustrates how the system processes flagging limits.

5-8

PN 773022BD

REVIEWING DATA

FLAGS

5.9 FLAGS

Flags appear to the right of the result. For some parameters, flagging occurs as a result of the flagging or editing of other parameters.

The LH 700 Series applies instrument-generated and/or laboratory-defined flags, codes, and/or messages to each set of patient results. Flags, codes, suspect and definitive messages are used to alert you to an instrument malfunction, specimen abnormality, abnormal data pattern, or abnormal results. Beckman Coulter recommends review, appropriate to your patient population, of all results displaying a flag, code or other message.

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5-9

REVIEWING DATA

FLAGS

IMPORTANT Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman

Coulter Inc. suggests using all available flagging options to optimize the sensitivity of instrument results based on your patient population. All flagging options include reference ranges (H/L), action and critical limits, definitive flags, suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter Inc. recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions. There may be situations where the presence of a rare events may fail to trigger a suspect message.

Look for data patterns when examining codes, flags and messages. For example, determine if some, all or related sets of results (for example, WBC and differential results) exhibit flags, codes and messages. For some parameters, flagging occurs as a result of the flagging or editing of other parameters. In all cases, follow you laboratory's policy for reviewing the sample.

IMPORT ANT Flagging is evaluated when the sample is analyzed. Flagging is reevaluated for a sample when

the results are manually edited, or when new results are received for a pending sample. Flagging is not reevaluated upon a change of flagging limits for results already in the database.

Flag Definition

Indicates reference interval low or high.

Indicates an action, critical or other flag.

* The MCV is < 50 fL. Some red cells may be smaller than the instrument's counting

threshold.

+ Result exceeds the reportable range.

IMPORTANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have + (flag), when cycling in

Manual mode, run a blank cycle before analyzing the next test sample to prevent carryover to the next sample. When cycling in Automatic mode, rerun the sample immediately following the one with the +. Sample dilutions may also result in wrong differential results. The instrument will automatically set to CBC mode when predilute is chosen.

aL Action low limit was exceeded. aH Action high limit was exceeded. cL Critical low limit was exceeded.

5-10

cH Critical high limit was exceeded. D Result triggered a Delta Check rule as defined by your laboratory. e Result has been calculated from a manually edited parameter. This flag overwrites +,

*, and R flags.

E Manual edit or a primary parameter 'E' overwrites +, * and R flags.

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H Reference interval high limit was exceeded. L Reference interval low limit was exceeded. P A partial aspiration was detected during sample analysis, or the blood detectors

R Review the result. Special handling is required for editing a result flagged with R.

5.10 CODES

Codes appear in place of results when the system cannot generate results. Codes are also called non-numeric results.

REVIEWING DATA

CODES

were disabled.

Any parameter derived from an R-flagged parameter cannot be recalculated until the R-flagged parameter is edited. R flags may also indicate a sy stem alarm occur r ed such as a flow cell error). Check the event log for details.

IMPORTANT Beckman Coulter In c. does no t claim to identify every abnormality in all samples. Beckman

Codes

..... Incomplete computation occurred. Incomplete computation may occur in place of

calculated parameters because a voteout or overrange occurred for a primary parameter used in the calculation.

- - - - - Total voteout occurred. No average histogram will appear for the affected parameter. If this code appears for WBC, the WBC and NRBC absolute count

results appear as an incomplete computation (.....) since the absolute counts are

calculated from the non-numeric WBC.

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5-11

REVIEWING DATA

SUSPECT MESSAGES

::::: Flow cell clog was detected. PC1, PC2 or FC will be displayed on the y-axis of the

dataplot

+++++ This result exceeds the instrument's operating range. Follow your laboratory’s

policies for reviewing the sample. Note: +++++ does not apply to NRBC%.

IMPORT ANT Incorrect results can occur. If the WBC, RBC, HGB, or PLT have +++++ (code), when cycling in

5.11 SUSPECT MESSAGES

Suspect messages appear for sample results based on an abnormal cell distribution or population. The system generates these messages according to an internal algorithm.

IMPORTANT Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman

Optimizing Efficiency

All sample results with suspect messages automatically appear in the Review Folder. Laboratories may differ in their desired sensitivity to abnormal cell types. The LH 700 Series

provides the laboratory with the ability to adjust the sensitivity of the differential suspect messages, to meet your individual requirements. The following suspect messages may be adjusted (refer to Flagging Preferences): Imm NE 1, Imm NE 2, Variant LY, Blast (all subtypes).

5-12

In order to optimize system efficienc y and clinical significance, Beckman Coulter, Inc. recommends completion of LH 700 Series-specific sensitivity and specificity studies using your sample population prior to adjusting message sensitivity.

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REVIEWING DATA

SUSPECT MESSAGES

IMPORTANT The operating temperature influences the rate of kinetic reactions. The LH 700 Series should

be recalibrated whenever the ambient temperature changes by 10 degrees Fahrenheit. If you have to recalibrate the CBC due to a large change in laboratory ambient temperature, you should also re-evaluate the differential flagging sensitivity settings for your typical patient population.

Message Source Notes

Abnormal Retic Pattern

Cellular Interference

Dimorphic Reds CBC Two populations of RBCs. Giant Platelets CBC Composite Plt, WBC and RBC histogram pattern consistent

Imm. NE1 Diff Immature neutrophil 1, suspect immature neutrophils,

Imm. NE 2 Diff Immature neutrophil 2, suspect immature neutrophils,

Low Event # Diff Less than 800 white cell events were counted for the

LY Blast Diff Suspect blasts in the lymphocyte area of the dataplot. Three

Retic Composite message triggered by an internal algorithm.

CBC WBC histogram pattern consistent with interference at 35

fL. A WBC correction has occurred. When the separation between the WBC population and interference is poorly defined on the histogram, a WBC correction is performed and the corrected WBC is flagged with R.

with giant platelets.

primarily bands. Can be disabled at Flagging Preferences. Three levels of sensitivity if enabled at Flagging Preferences.

primarily metamyelocytes, myelocytes and promyelocytes Three levels of sensitivity available at Flagging Preferences.

differential. R appears next to differential and NRBC percentages and absolute numbers.

levels of sensitivity available at Flagging Preferences.

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MO Blast Diff Suspect blasts in the monocyte area of the dataplot. Three

levels of sensitivity available at Flagging Preferences.

NE Blast Diff Suspect blasts in the neutrophil area of the dataplot. Three

levels of sensitivity available at Flagging Preferences.

NRBC Diff Suspect nucleated red blood cells. Note: This Suspect

Message will not be displayed if you have enabled either NRBC% or NRBC#.

Platelet Clumps CBC Platelet histogram, WBC histogram, and RBC histogram

patterns consistent with platelet clumps, fragmented red cells, or small red cells.

RBC Interference

Red Cell Agglutination

CBC MCV < 50 fL, flagged MCV*. The RBC, Hct, MCH, MCHC,

RDW, RDW-SD, Plt, MPV and RET# display with an R flag.

CBC. MCV > 110 fL, MCHC > 40.0 g/dL.

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REVIEWING DATA

DEFINITIVE MESSAGES

Variant LY Diff Suspect variant lymphocytes. Three levels of sensitivity

Verify Diff Diff An unexpected data pattern is encountered. Also generated

Verify Retic Retic An unexpected data pattern is encountered. R appears next

available at Flagging Preferences.

when WBC > 1.5 x 10

cells/µL and MO% > 20. R appears next to differential and NRBC perc enta ges and absolute numbers.

to RET%, RET#, IRF and MRV.

WBC Exceeds

CBC The uncorrected WBC > 400.0 x 103 cells/µL. A plus sign

Linearity

5.12 DEFINITIVE MESSAGES

Definitive Messages appear for sample results based on exceeded action limits. The messages are configured as part of your flagging limits set.

IMPORTANT Beckman Coulter Inc. does not claim to identify every abnormality in all samples. Beckman

(+) appears next to the WBC and UWBC. R appears next to the RBC, Hgb, Hct, MCV, MCH, MCHC, RDW and RDW -SD, as well as the differential percentages and numbers.

5-14

Definitive Messages

Definitive messages appear for sample results based on action limits exceeded for age only. The messages are set up as part of your flagging limits.

Result Exceeds the Action

Message

Anemia RBC or Hgb low Pancytopenia overrides this message. Anisocytosis (with

gradient ranges)

Limit for Notes

RDW high

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REVIEWING DATA

DEFINITIVE MESSAGES

Basophilia BA% or BA# high Eosinophilia EO% or EO# high Erythrocytosis RBC high H&H Check Failed Hct < ((Hgb*3) - 3)

Hct > ((Hgb * 3)+3) Hypochromia (X) MCH low X indicated 1+ or 2+ gradient range Large Platelets MPV high Leukopenia WBC low Overwritten by Pancytopenia Leukocytosis WBC high Lymphopenia LY% or LY# low Lymphocytosis LY% or LY# high

Macrocytosis (with gradient ranges)

Microcytosis (with gradient ranges)

Monocytosis MO% or MO# high Neutropenia NE% or NE# low Neutrophilia NE% or NE# high Pancytopenia WBC, RBC and Plt low Overwrites Anemia, Leukopenia and

Reticulocytosis RET% or RET# high Small Platelets MPV low Thrombocytopenia Plt low Overwritten by Pancytopenia Thrombocytosis Plt high

MCV high

MCV low

Thrombocytopenia

Auto Validation Overview

The enhanced Auto Validation procedure provides information as to the state of the sample. The sample can have one of three states with respect to validation:

r Auto Validated, meaning that it has passed all criteria for validation r Validated, meaning that although it failed at least one criteria, the sample has been

manually validated

r Not Validated, meaning that the sample failed at least one criteria and has not been

manually validated.

On the screen, samples which are Auto Validated will not appear in the Reflex, Delta, or Review folders, and will not have the Validate button enabled. If the sample fails validation for non-decision rule criteria, it would appear in the Review Folder. If the sample fails for

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5-15

REVIEWING DATA

DEFINITIVE MESSAGES

Decision Rule criteria, it could appear in either the Delta Check or Reflex folders (depending which one was triggered), or in the Review folder, depending whether they have configured Delta Check and Reflex failures to go to the Review folder. It is possible, if the sample fails both decision rule-related and non-rule related criteria, for the sample to appear in both or all three folders. If the user reviews and manually validates the sample, it would no longer appear in any of these folders, and the validate button would be in a depressed state when that single sample is selected.

For the print and host transmission, these messages are output as "Sample Auto Validated", "Sample Not Validated", or "Sample Validated". In addition, individual codes will provide validation information for predefined parameter sets, referred to as parameter blocks. If at least one parameter from the parameter block is included in the reported results, the appropriate validation code will be displayed. The codes may be disabled for host transmission in the Host Communications Setup area.

The major difference between the screen and print is that the screen is not profile specific. This means that on screen, all parameters, suspect/definitive messages, and rules triggered will be displayed, and the validation status depends on the whole sample. For the print and host transmission, only those parameters, suspect/definitive messages, and rule messages which are part of the profile are output, and the validation codes and messages are based on this output.

The logic for arriving at the validation status is as follows: W e first r educe the parameters to an active set. The set of active parameters starts with the set

of parameters which is enabled for the system in parameter setup. It is further reduced to those parameters which were either run on the analyzer or edited into the sample. For printing and transmission, the active set is further reduced to the parameters included in the selected profile. If the status we are looking for is a validation code, the active set is further reduced to the parameters applicable to that code.

For example, suppose that all parameters are enabled for the system. Now suppose that a CR sample is run. W e are now only looking at CR parameters. Now if we are looking at the printout and the selected profile is CBC, we are reduced to only the CBC parameters. To determine the status of the Validation Message, we are looking for all the CBC parameters. To determine the status of the parameter codes, such as the C Code (CBC parameter block), then we're still looking at all CBC parameters. If it is H Code, we're looking at only Hgb and Hct parameters. The W code only looks at the WBC, Hgb and Plt parameters If we're looking for the D code (Diff parameter block) or R code (Reticulocyte block), we have no parameters, and the code would not be displayed.

Now that we know which parameters to include, we will look for anything which causes an Auto Validation failure:

r Any active parameter which exceeds limits, where the limit has been configured as

autoverification criteria. This could also be based on a definitive message, where the definitive set has been specified as autoverification criteria.

r H & H Check Failed is a separate check. Since it is not tied to any limit set, it can not be

configured as autoverification criteria. It will always trigger a failure when both HGB and HCT are part of the active set.

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REVIEWING DATA

DEFINITIVE MESSAGES

r Any active parameter which has a nonnumeric value (+++++, :::::, ....., -----), a Review

flag, Partial Aspiration (P), exceeds linearity (+), or MCV exceeds threshold (*).

r Any suspect flag, where the active parameter set includes at least one parameter from the

suspect message parameter group. Suspect messages are associated with either CBC, Diff, or Retic parameters. If, for example, a CBC suspect message is triggered and at least one CBC parameter is in the active set, we have an autovalidation failure.

Any reflex or delta rule, where ALL parameters included in the rule must be in the active set.

r When editing the WBC / HGB / PLT Report configuration, enabling or disabling the

UWBC parameter will also cause UWBC to be included or excluded from consideration in the 'W' validation code that can be included in printouts and host transmission. The 'W' validation code will use the same parameters defined in the WBC / HGB / PL T repor t, if they are enabled in the Report Format in use.

IMPORTANT Several precautions have been taken to ensure integrity of Manual Validation. If new data is

collated to a sample, if the sample is edited in a way that would cause a reflag, or if the profile is changed, manual validation for the sample is cleared.

Auto Validation Example

Auto Validation Setup

r Enable Validation Codes r Enable Auto Validation Criteria for Action Limits r Enable Decision rules = Reflex rule is defined as "If Retic % < 0.2 then Make Retic Smear

and scan slide.”

Sample Setup:

r Test Mode = CBC/Diff r Patient Sample preassigned with a CBC and Retic Report Profile

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REVIEWING DATA

DEFINITIVE MESSAGES

Sample Results: (printed and transmitted)

WBC

End of Completed Report, Sample Not Validated, C NV, H AV, W NV

Manual Validation:

Once the results are reviewed and manually validat ed at the LH Workstation the report appears as follows.

Comments: Make Retic Smear and scan slide

4.8 x 10

cells/µL

RBC

2.53 x 106 cells/µL Hgb 6.3 g/dL MPV 10.3 fL Hct 19.6 % MCV 77.4 fL MCH 24.9 pg MCHC 32.1 g/dL RDW 16.1 % Ret % % Ret #

x 10

cells/µL

Plt

80 aL x 103 cells/µL

Comments: WBC

4.8 x 10

cells/µL

RBC

2.53 x 106 cells/µL Hgb 6.3 g/dL MPV 10.3 fL Hct 19.6 % MCV 77.4 fL MCH 24.9 pg MCHC 32.1 g/dL RDW 16.1 % Ret % % Ret #

x 10

cells/µL

End of Completed Report, Sample Validated, C V, H AV, W V

Plt

80 aL x 103 cells/µL

5-18

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Beckman Coulter 773022BE University Physics Volume 1

Specifications and Main Features

Frequently Asked Questions

User Manual

COULTER LH 780 System

Instructions for Use

WARNINGS AND PRECAUTIONS

WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows:

WARNING Risk of operator injury if:

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

REVISION STATUS

Issue A, 12/06 Software version 1A. Manual derived from Help version 1A.063001.

Issue B, 10/07 Software version 1B. Manual derived from Help version 1B.072681.

Issue BA, 08/09 Software version 1B1. Manual derived from Help version 1B1.091732.

Issue BB, 10/10 Software version 1B1.

Issue BD, 12/11 Software version 1B1.

Changes were made to:

Issue BE, 01/13 Software version 1B3. Manual derived from Online Help 1B3.

Changes were made to:

CONTENTS

This introductory section contains the following topics:

INTRODUCTION

HOW TO USE YOUR COULTER LH 780 SYSTEM HARD-COPY MANUALS

ABOUT THIS MANUAL

ONLINE HELP SYSTEM

CONVENTIONS

This document uses the following conventions:

indicates a key on the Numeric keypad.

indicates a key on the LH Workstation keyboard.

is the icon for Patient results on the LH Workstation.

is the icon for the Printer on the LH Workstation.

1.1 ANALYZER

CONTROLS AND INDICATORS

Analyzer Screen and CRT Buttons

1.2 DILUTER

Numeric Keypad

Move the cursor over the illustration in Help to see links to additional information.

Numeric Keypad--.

Press to add a decimal point.

Numeric Keypad--0-9

Example: Press to specify the Prime CBC Lytic Reagent function.

Numeric Keypad--Alarm Reset

Numeric Keypad--CE

Numeric Keypad--CLEAR APERT

Numeric Keypad--DRAIN

Empty the WBC bath through the Hgb cuvette into the waste chamber.

Numeric Keypad--ENTER

Press after you provide a sample identification or specify a function.

Example: Press to specify the Prime CBC Lytic Reagent function.

If a function is active, press this button a second time to perform the function again.

Numeric Keypad--F

Press before you specify the number of a function you want to perform.

Example: Press to specify the Prime CBC Lytic Reagent function.

Press to repeat the function.

Numeric Keypad--ID

Numeric Keypad--POWER OFF

Press to turn the instrument off. The Workstation and printer remain turned on.

Numeric Keypad--POWER ON

Press to turn the instrument on.

Initializes the Analyzer and Diluter hardware and software.

Puts various mechanical devices into the correct starting position.

Displays the current version of the instrument.

Numeric Keypad--PREMIX

Numeric Keypad--PRIME APERT

Numeric Keypad--RINSE

Numeric Keypad--SHUT DOWN

Check Wa ste level and notify you if a full condition exists to avoid biohazard overflow.

Turn the compressor off.

Numeric Keypad--START UP

Numeric Keypad--START/CONT

Press to start or continue automatic sample processing.

Numeric Keypad--STOP

If the rocker bed is mixing samples, pressing this button stops the mixing process.

Press twice to release the stripper plate.

Note: Pressing does not stop startup or shutdown cycles.

1.3 POWER SUPPLY

Side/Front

The Power Supply allows you to monitor:

Back

Power Supply Function Levels