ERBA ELite 5 Manuale utente

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ

ELite 5

Hematology Analyzer

USER MANUAL

INS00068

Page 2 of 159

Introduction

This user manual is intended to give detailed information for end users of the ‘ELite 5’ optical

hematology analyzer.

All information contained herein is the intellectual property of Erba Lachema s.r.o. and should

not be used or reproduced without prior agreement of Erba Lachema s.r.o., the

manufacturer.

This manual was written with the intention to give the most precise and up-to-date, detailed

description of operation and use of the analyzer for laboratory purposes.

Despite careful revision and multiple grammar and content control, mistakes can still be

present in this manual. Erba Lachema may from time to time issue errata, or a new revision

of the manual. Would you find things unclear, please contact your service engineer for

assistance.

Descriptions contained herein are relevant to ‘ELite 5’, software versions (latest available at

the publication of the manual):

High Level SW version: 1.5.2105.0

Low Level SW version: 1.5.2105.0

Low Level boot version 2.0

Firmware: 2.78 (1208)

PIC SW: 2.1

Laser SW: 3.5

TCU SW: 3.42

Page 3 of 159

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR

FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

Erba Lachema’s obligation or liability under this warranty does not include any transportation

or other charges or liability for direct, indirect or consequential damages or delay resulting

from the improper use or application of the product or the use of parts or accessories not

approved by Erba Lachema or repairs by people other than Erba Lachema authorized

personnel.

This warranty shall not extend to:

•Any Erba Lachema product which has been subjected to misuse, negligence or

accident.

•Any Erba Lachema product from which Erba Lachema’s original serial number tag or

product identification markings have been altered or removed.

•Any product of any other manufacturer.

Content

Page 4 of 159

Table of Contents

For Your Safety ........................................................................................................ 10

1.1 Who Should Use This Manual ....................................................................................... 10

1.2 Spe ial symbols used in this Manual............................................................................. 10

1.3 General Pre autions .................................................................................................... 10

1.4 Environmental Fa tors ................................................................................................. 11

1.5 Ele tri al Requirements ............................................................................................... 12

1.6 Spa e Requirements .................................................................................................... 12

1.7 Weight Requirements .................................................................................................. 14

1.8 Waste Disposal ............................................................................................................ 15

1.9 Known Limitations ....................................................................................................... 15

1.10 Emergen y Situations .................................................................................................. 15

Product Support ....................................................................................................... 16

Installation .............................................................................................................. 17

3.1 Pa kage ontents ......................................................................................................... 17

3.1.1

The ‘ELite 5’ Analyzer Package ....................................................................................................... 1

3.1.2

The Autosampler Package ............................................................................................................. 1

3.1.3

Small Sample Package (optional) ................................................................................................... 1

3.2 Conne ting the reagents .............................................................................................. 18

3.3 Power onne tion ........................................................................................................ 18

3.4 Conne tions to the peripherals .................................................................................... 18

3.5 Environmental onditions ............................................................................................ 18

3.6 Visual inspe tion ......................................................................................................... 19

3.7 Moving to the sele ted lo ation ................................................................................... 19

3.8 Removing the safety ard from the shear valve ............................................................ 19

3.9 Conne ting the Autosampler ........................................................................................ 20

3.10 Conne ting the reagents .............................................................................................. 20

General O er iew and Principles of Operation .......................................................... 21

4.1 General Overview ........................................................................................................ 21

4.1.1

Measured Parameters ................................................................................................................... 21

4.1.2

Approved Reagents and Control Materials .................................................................................... 22

4.1.3

Original Erba Lachema Reagents ................................................................................................... 22

4.2 Prin iples of Operation ................................................................................................ 24

4.2.1

Volumetric Impedance Method ..................................................................................................... 24

4.2.2

Photometric Light Absorbance Method ........................................................................................ 24

Content

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4.2.3

Optical Light Scatter and Diffraction Method ................................................................................ 25

Inside the ‘ELite 5’ Analyzer .................................................................................................... 28

4.2.4

Front Panel ..................................................................................................................................... 28

4.2.5

Back Panel ...................................................................................................................................... 28

4.2.6

Left Side Assembly ......................................................................................................................... 30

4.2.

Right Side Assembly ....................................................................................................................... 31

4.2.8

Front Assembly .............................................................................................................................. 32

4.3 Small Sample Mode (SSM) – optional ........................................................................... 32

User Interface .......................................................................................................... 34

5.1 Using the Tou h S reen ................................................................................................ 34

5.2 Using the ‘Start’ Button ............................................................................................... 34

5.3 Using an External Mouse ............................................................................................. 34

5.4 Using an External Keyboard ......................................................................................... 35

5.5 Using the On-S reen Virtual Keypads ........................................................................... 35

5.6 Using the Graphi al User Interfa e ............................................................................... 37

5.6.1

Quick Links ..................................................................................................................................... 3

5.6.2

Interactive Display Area ................................................................................................................. 3

5.6.3

Status Display ................................................................................................................................. 38

5.6.4

Entering Information ..................................................................................................................... 38

5.7 The Menu System ........................................................................................................ 38

5. .1

Primary Menu Items ...................................................................................................................... 38

5. .2

Starting a Manual Single Tube Measurement ............................................................................... 38

5. .3

Start Automated Measurements ................................................................................................... 39

5. .4

Access the Database ...................................................................................................................... 39

5. .5

Initiate Printing .............................................................................................................................. 39

5. .6

Main Menu .................................................................................................................................... 40

5. .

Autosampler (AS) Control Panel .................................................................................................... 40

5. .8

Adjust the Time and Date .............................................................................................................. 40

5. .9

Open the Warning Panel ................................................................................................................ 40

5. .10

Menu tree ...................................................................................................................................... 41

5. .11

Safety Access Codes ....................................................................................................................... 43

5. .12

SSM Menu Add-ons ....................................................................................................................... 43

Start Up and Shut Down of ‘ELite 5’ .......................................................................... 45

6.1 Start Up and Shut Down Overview ............................................................................... 45

6.2 Starting Up the ‘ELite 5’ Analyzer ................................................................................. 45

6.2.1

Visual Inspection ............................................................................................................................ 45

6.2.2

Power Up the ‘ELite 5’ Analyzer ..................................................................................................... 45

6.2.3

Start Up the User Interface ............................................................................................................ 46

6.2.4

User Login ...................................................................................................................................... 4

6.2.5

Pneumatic System Start and Blank Measurement ........................................................................ 4

6.3 Exiting the ‘ELite 5’ Analyzer ........................................................................................ 48

6.3.1

Log Off ............................................................................................................................................ 48

6.3.2

Shut Down...................................................................................................................................... 49

Content

Page 6 of 159

6.3.3

Prepare for Shipment .................................................................................................................... 49

6.3.4

Emergency Shut Down ................................................................................................................... 52

6.3.5

Repackaging the ‘ELite 5’ Analyzer ................................................................................................ 53

Sample Measurement .............................................................................................. 55

7.1 Sample Types Supported by the ‘ELite 5’ ...................................................................... 55

.1.1

Supported Sample Tube Types ...................................................................................................... 55

.1.2

Sampling Depth .............................................................................................................................. 55

.1.3

Open or Closed Sample Tubes ....................................................................................................... 56

.1.4

Sample Collection and Handling .................................................................................................... 56

7.2 Sample Types and Modes ............................................................................................ 57

7.3 Sample Identifi ation ................................................................................................... 57

7.4 Running Samples ......................................................................................................... 58

.4.1

Manual Mode ................................................................................................................................ 58

.4.2

Prediluted mode ............................................................................................................................ 61

.4.3

Automatic Mode ............................................................................................................................ 62

7.5 Result Display .............................................................................................................. 72

7.6 Printing Reports........................................................................................................... 72

7.7 The Measurement Pro ess ........................................................................................... 72

Result Interpretation ................................................................................................ 74

8.1 The Result S reen ........................................................................................................ 74

8.2 Sample Identifi ation Information ................................................................................ 74

8.3 Parameter Information ................................................................................................ 75

8.3.1

Scatter Diagrams and Histograms .................................................................................................. 6

8.3.2

Warnings ........................................................................................................................................

Database Functions .................................................................................................. 85

9.1 Database Overview ...................................................................................................... 85

9.2 S rolling the Database View ......................................................................................... 86

9.3 Sorting Database Information ...................................................................................... 87

9.4 Manual Sele tion of Database Re ords ......................................................................... 87

9.5 Automati Sele tion of Database Re ords .................................................................... 88

9.6 Viewing Detailed Results ............................................................................................. 88

9.7 Statisti s ...................................................................................................................... 88

9.8 Managing Database Re ords ........................................................................................ 88

9.8.1

Select By ......................................................................................................................................... 89

9.8.2

Importing ....................................................................................................................................... 90

9.8.3

Export ............................................................................................................................................. 91

9.8.4

Send to LIS...................................................................................................................................... 91

9.8.5

Save Tab File .................................................................................................................................. 91

9.8.6

Save Raw Data ............................................................................................................................... 92

9.8.

Delete ............................................................................................................................................. 92

Content

Page of 159

Calibration ........................................................................................................... 93

10.1 Calibrating the ‘ELite 5’ ................................................................................................ 94

10.1.1

View Calibrations ........................................................................................................................... 95

10.2 SSM Calibration ........................................................................................................... 96

Quality Control ..................................................................................................... 97

11.1 Set QC Referen e ......................................................................................................... 97

11.2 QC Measure................................................................................................................. 99

11.3 View QC Referen es ..................................................................................................... 99

11.4 View QC Data .............................................................................................................. 99

11.5 View QC Diagrams ....................................................................................................... 99

11.6 View X-B Data............................................................................................................. 100

11.7 View X-B diagrams ...................................................................................................... 101

Patients ............................................................................................................ 102

Settings ............................................................................................................... 104

13.1 Customize Settings ..................................................................................................... 104

13.2 Laboratory Settings..................................................................................................... 105

13.3 External Devi es ......................................................................................................... 106

13.4 System Settings .......................................................................................................... 107

13.5 Units .......................................................................................................................... 108

13.6 Printer Settings ........................................................................................................... 109

13.7 Profile Limits Settings ................................................................................................. 110

13.8 X-B Settings ................................................................................................................ 111

13.9 User Settings .............................................................................................................. 112

13.10 Date and Time Adjustment ...................................................................................... 113

Instrument Diagnostics ........................................................................................ 114

14.1 Self Test of the Analyzer ............................................................................................. 115

14.2 Daily Log .................................................................................................................... 117

14.3 Reagent Status ........................................................................................................... 117

14.4 Statisti s ..................................................................................................................... 118

14.5 Information ................................................................................................................ 118

Maintenance ....................................................................................................... 120

15.1 Opening the Front Panel ............................................................................................. 120

15.1.1

Closing the Front Panel ................................................................................................................ 121

15.1.2

Removing the Side Panels ............................................................................................................ 121

Content

Page 8 of 159

15.1.3

User Maintainable Parts of the Analyzer ..................................................................................... 121

15.2 Maintenan e Programs of the Analyzer ....................................................................... 122

15.2.1

Cleaning the Shear Valve ............................................................................................................. 123

15.2.2

Cleaning the Washing Head ......................................................................................................... 12

15.2.3

Cleaning the Measuring Chambers (Hard Cleaning) .................................................................... 128

15.2.4

Daily Cleaning .............................................................................................................................. 128

15.2.5

Special Cleaning Procedure .......................................................................................................... 128

15.2.6

Replacing Reagents ...................................................................................................................... 129

15.2.

Disposal of Reagent Containers ................................................................................................... 130

Reagent Locking .................................................................................................. 131

The Daily-Routine ................................................................................................ 132

Troubleshooting .................................................................................................. 134

18.1 Software error messages ............................................................................................ 134

18.2 Pneumati error messages .......................................................................................... 134

18.3 Me hani al Problems .................................................................................................. 135

18.4 Sample Rotor (SR) Failures .......................................................................................... 135

18.4.1

SR Gives Grinding Noise And / Or SW Displays SR Error Messages ............................................. 135

18.4.2

SR Error Appears During Initialization Process: ........................................................................... 136

18.4.3

The SR Does Not Turn Into the Analyzer Even With Open Front Panel ....................................... 136

18.5 Needle Me hani s, Verti al Motor (Mvert) Problems ................................................... 136

18.5.1

The Needle Carriage Keeps Dropping Back (Down) At Initialization ............................................ 136

18.6 Shear Valve (SV) Related Errors ................................................................................... 136

18.6.1

SV Error at the First Startup ......................................................................................................... 136

18.6.2

Grinding Noise after SV Cleaning, (after SV Reinstallation) ......................................................... 136

18.6.3

SV Leakage ................................................................................................................................... 136

18.7 Dilutor Errors .............................................................................................................. 137

18.8 Priming Problems ....................................................................................................... 137

18.8.1

The Analyzer Would Not Prime Liquids ....................................................................................... 13

18.9 Ele troni s Related Problems ...................................................................................... 137

18.9.1

No Image on Display, No Backlight .............................................................................................. 13

18.9.2

Touch Sensitive Surface Not Working .......................................................................................... 13

18.9.3

Touch (Click) Is Inaccurate ........................................................................................................... 13

18.9.4

The Cursor Seems To Be Moving With Good Ratios, But In a Smaller Area ................................ 13

18.10 The Analyzer Does Not Power On ............................................................................ 137

18.11 I2 Errors Displayed At Startup ................................................................................ 137

18.12 Measurement results related problems ................................................................... 138

18.12.1

Fluctuating PLT background values .............................................................................................. 138

18.12.2

Long, smeared population ........................................................................................................... 138

Accessories .......................................................................................................... 139

Appendices .......................................................................................................... 140

20.1 Reagent Consumption ................................................................................................ 140

Content

Page 9 of 159

20.2 Display Range ............................................................................................................. 141

20.3 Printed Report Formats .............................................................................................. 142

20.4 Spe ifi ations ............................................................................................................. 144

20.4.1

Measured Parameters ................................................................................................................. 144

20.4.2

Technical Data .............................................................................................................................. 145

20.4.3

Performance Data ........................................................................................................................ 148

20.4.4

Reagent System ........................................................................................................................... 151

20.4.5

Tab File Format ............................................................................................................................ 152

20.5 Fluidi System............................................................................................................. 153

20.6 Summary of Cleaning Produ ts and Pro edures for Elite Hematology Analyzers ........... 154

Known Problems .................................................................................................. 155

Index ................................................................................................................... 156

Contact ................................................................................................................ 158

Appendix- package inserts for reagents and cleaning solutions ............................ 159

ELite 5, User Manual

Page 10 of 159

1 For Your Safety

1.1 Who Should Use This Manual

This User Manual is intended for clinical laboratory professionals using the ‘ELite 5’

automated hematology analyzer. The Manual includes information about the operation and

user interface of the ‘ELite 5’ analyzer.

It also contains basic steps necessary to perform the setup procedures to adapt the

operation of the analyzer to the requirements of your laboratory.

This manual also describes daily routine maintenance requirements to keep your analyzer

functioning properly.

1.2 Special symbols used in this Manual

Label

Meaning Explanation

Biohazard Blood samples and analyzer waste are potentially

infectious materials.

Corrosive Reagents may cause corrosion or skin irritation.

Warning General warning of possible hazard conditions.

Sharp needle warning The sampling needle may be a hazard to the operator.

1.3 General Precautions

The analyzer weighs 35kg (~77lbs).Please do not attempt to move it alone. The

analyzer should always be moved by two persons holding the analyzers by its sides

in an upright position.

Always use safe lifting procedures when lifting the analyzer.

Make sure to retain the original packaging material for safe transportation and

storage in the future.

To prepare the analyzer for shipping, storage or extended periods of inactivity,

please drain the reagents and repackage the ‘ELite 5’ in its original packaging. Do

not expose the ‘ELite 5’ to direct sunlight, extreme temperature or humidity (>80%).

The analyzer operates with chemically and biologically active reagents. Physical

contact with these reagents should be avoided. Please read reagent descriptions

carefully for possible emergency actions.

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