ERBA ELite 5 User Manual
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
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Table of Contents
1 For Your Safety ........................................................................................................ 10
1.1 Who Should Use This Manual ....................................................................................... 10
1.2 Special symbols used in this Manual............................................................................. 10
1.3 General Precautions .................................................................................................... 10
1.4 Environmental Factors ................................................................................................. 11
1.5 Electrical Requirements ............................................................................................... 12
1.6 Space Requirements .................................................................................................... 12
1.7 Weight Requirements .................................................................................................. 14
1.8 Waste Disposal ............................................................................................................ 15
1.9 Known Limitations ....................................................................................................... 15
1.10 Emergency Situations .................................................................................................. 15
2 Product Support ....................................................................................................... 16
3 Installation .............................................................................................................. 17
3.1 Package contents ......................................................................................................... 17
3.1.1 The ‘ELite 5’ Analyzer Package ....................................................................................................... 17
3.1.2 The Autosampler Package ............................................................................................................. 17
3.1.3 Small Sample Package (optional) ................................................................................................... 17
3.2 Connecting the reagents .............................................................................................. 18
3.3 Power connection ........................................................................................................ 18
3.4 Connections to the peripherals .................................................................................... 18
3.5 Environmental conditions ............................................................................................ 18
3.6 Visual inspection ......................................................................................................... 19
3.7 Moving to the selected location ................................................................................... 19
3.8 Removing the safety card from the shear valve ............................................................ 19
3.9 Connecting the Autosampler ........................................................................................ 20
3.10 Connecting the reagents .............................................................................................. 20
4 General Overview 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 Principles 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
4.2.7 Right Side Assembly ....................................................................................................................... 31
4.2.8 Front Assembly .............................................................................................................................. 32
4.3 Small Sample Mode (SSM) – optional ........................................................................... 32
5 User Interface .......................................................................................................... 34
5.1 Using the Touch Screen ................................................................................................ 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-Screen Virtual Keypads ........................................................................... 35
5.6 Using the Graphical User Interface ............................................................................... 37
5.6.1 Quick Links ..................................................................................................................................... 37
5.6.2 Interactive Display Area ................................................................................................................. 37
5.6.3 Status Display ................................................................................................................................. 38
5.6.4 Entering Information ..................................................................................................................... 38
5.7 The Menu System ........................................................................................................ 38
5.7.1 Primary Menu Items ...................................................................................................................... 38
5.7.2 Starting a Manual Single Tube Measurement ............................................................................... 38
5.7.3 Start Automated Measurements ................................................................................................... 39
5.7.4 Access the Database ...................................................................................................................... 39
5.7.5 Initiate Printing .............................................................................................................................. 39
5.7.6 Main Menu .................................................................................................................................... 40
5.7.7 Autosampler (AS) Control Panel .................................................................................................... 40
5.7.8 Adjust the Time and Date .............................................................................................................. 40
5.7.9 Open the Warning Panel ................................................................................................................ 40
5.7.10 Menu tree ...................................................................................................................................... 41
5.7.11 Safety Access Codes ....................................................................................................................... 43
5.7.12 SSM Menu Add-ons ....................................................................................................................... 43
6 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 ...................................................................................................................................... 47
6.2.5 Pneumatic System Start and Blank Measurement ........................................................................ 47
6.3 Exiting the ‘ELite 5’ Analyzer ........................................................................................ 48
6.3.1 Log Off ............................................................................................................................................ 48
6.3.2 Shut Down...................................................................................................................................... 49
Content
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6.3.3 Prepare for Shipment .................................................................................................................... 49
6.3.4 Emergency Shut Down ................................................................................................................... 52
6.3.5 Repackaging the ‘ELite 5’ Analyzer ................................................................................................ 53
7 Sample Measurement .............................................................................................. 55
7.1 Sample Types Supported by the ‘ELite 5’ ...................................................................... 55
7.1.1 Supported Sample Tube Types ...................................................................................................... 55
7.1.2 Sampling Depth .............................................................................................................................. 55
7.1.3 Open or Closed Sample Tubes ....................................................................................................... 56
7.1.4 Sample Collection and Handling .................................................................................................... 56
7.2 Sample Types and Modes ............................................................................................ 57
7.3 Sample Identification ................................................................................................... 57
7.4 Running Samples ......................................................................................................... 58
7.4.1 Manual Mode ................................................................................................................................ 58
7.4.2 Prediluted mode ............................................................................................................................ 61
7.4.3 Automatic Mode ............................................................................................................................ 62
7.5 Result Display .............................................................................................................. 72
7.6 Printing Reports........................................................................................................... 72
7.7 The Measurement Process ........................................................................................... 72
8 Result Interpretation ................................................................................................ 74
8.1 The Result Screen ........................................................................................................ 74
8.2 Sample Identification Information ................................................................................ 74
8.3 Parameter Information ................................................................................................ 75
8.3.1 Scatter Diagrams and Histograms .................................................................................................. 76
8.3.2 Warnings ........................................................................................................................................ 77
9 Database Functions .................................................................................................. 85
9.1 Database Overview ...................................................................................................... 85
9.2 Scrolling the Database View ......................................................................................... 86
9.3 Sorting Database Information ...................................................................................... 87
9.4 Manual Selection of Database Records ......................................................................... 87
9.5 Automatic Selection of Database Records .................................................................... 88
9.6 Viewing Detailed Results ............................................................................................. 88
9.7 Statistics ...................................................................................................................... 88
9.8 Managing Database Records ........................................................................................ 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
9.8.7 Delete ............................................................................................................................................. 92
Content
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10 Calibration ........................................................................................................... 93
10.1 Calibrating the ‘ELite 5’ ................................................................................................ 94
10.1.1 View Calibrations ........................................................................................................................... 95
10.2 SSM Calibration ........................................................................................................... 96
11 Quality Control ..................................................................................................... 97
11.1 Set QC Reference ......................................................................................................... 97
11.2 QC Measure................................................................................................................. 99
11.3 View QC References ..................................................................................................... 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
12
Patients ............................................................................................................ 102
13 Settings ............................................................................................................... 104
13.1 Customize Settings ..................................................................................................... 104
13.2 Laboratory Settings..................................................................................................... 105
13.3 External Devices ......................................................................................................... 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
14 Instrument Diagnostics ........................................................................................ 114
14.1 Self Test of the Analyzer ............................................................................................. 115
14.2 Daily Log .................................................................................................................... 117
14.3 Reagent Status ........................................................................................................... 117
14.4 Statistics ..................................................................................................................... 118
14.5 Information ................................................................................................................ 118
15 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
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15.1.3 User Maintainable Parts of the Analyzer ..................................................................................... 121
15.2 Maintenance Programs of the Analyzer ....................................................................... 122
15.2.1 Cleaning the Shear Valve ............................................................................................................. 123
15.2.2 Cleaning the Washing Head ......................................................................................................... 127
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
15.2.7 Disposal of Reagent Containers ................................................................................................... 130
16 Reagent Locking .................................................................................................. 131
17 The Daily-Routine ................................................................................................ 132
18 Troubleshooting .................................................................................................. 134
18.1 Software error messages ............................................................................................ 134
18.2 Pneumatic error messages .......................................................................................... 134
18.3 Mechanical 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 Mechanics, Vertical 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 ....................................................................................... 137
18.9 Electronics Related Problems ...................................................................................... 137
18.9.1 No Image on Display, No Backlight .............................................................................................. 137
18.9.2 Touch Sensitive Surface Not Working .......................................................................................... 137
18.9.3 Touch (Click) Is Inaccurate ........................................................................................................... 137
18.9.4 The Cursor Seems To Be Moving With Good Ratios, But In a Smaller Area ................................ 137
18.10 The Analyzer Does Not Power On ............................................................................ 137
18.11 I2c 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
19 Accessories .......................................................................................................... 139
20 Appendices .......................................................................................................... 140
20.1 Reagent Consumption ................................................................................................ 140
Content
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20.2 Display Range ............................................................................................................. 141
20.3 Printed Report Formats .............................................................................................. 142
20.4 Specifications ............................................................................................................. 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 Fluidic System............................................................................................................. 153
20.6 Summary of Cleaning Products and Procedures for Elite Hematology Analyzers ........... 154
21 Known Problems .................................................................................................. 155
22 Index ................................................................................................................... 156
23 Contact ................................................................................................................ 158
24 Appendix- package inserts for reagents and cleaning solutions ............................ 159
ELite 5, User Manual
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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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To ensure reliable operation and reliable results:
• Only human blood samples should be analyzed
• Only original Erba Lachema reagents should be used
• Required maintenance (user and service level) should be performed as
recommended in this Manual
• Only Erba Lachema certified service personnel should perform service
actions
• Only original Erba Lachema service materials and spare parts should be
used
Original reagents and service materials and spare parts are available from Erba
Lachema.
Only Erba Lachema certified service personnel that have successfully completed
the ‘Erba Lachema ELite 5 Service Training program are qualified to service the
‘ELite 5’ analyzer.
Before operating the ‘ELite 5’ analyzer, all operators should complete the ‘Erba
Lachema ELite 5 Operator Training’ program. This program is offered by Erba
Lachema or by Erba Lachema certified service personnel.
Replacement materials or spare parts (tubes, valves, etc.) which might have been in
contact with human blood or reagents should be handled as a potentially
biologically hazardous and chemically dangerous material. All applicable laws and
regulations must be observed in the handling and disposal of these materials.
The ‘ELite 5’ is designed for laboratory operation. Mobile operation is not supported.
Operate ‘ELite 5’ within the ambient temperature range described in section 1.4.
The IVD equipment complies with the emission and immunity requirements
described in relevant part of the IEC 61326 series.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to reduce the interference.
Electromagnetic environment should be evaluated prior to operation of the device.
This analyzer contains electronic components. Please handle electronic
waste adhering to local or federal regulations.
1.4 Environmental Factors
Operate the ‘ELite 5’ analyzer at the ambient temperature within the range of 15-30°C
(59-86 °F) and a relative humidity range of 10% - 80%. The optimum operating temperature
is 25°C (~77°F).
Avoid exposing the ‘ELite 5’ analyzer to direct sunlight or to extreme high or low
temperatures. If the ‘ELite 5’ analyzer was subjected to extreme temperatures during
shipment or storage, the analyzer must be placed for at least one hour in a room whose
temperature is within the operational range before installation or use.
Reagents should be stored within the temperature range of 15-30°C (59-86 °F).
The analyzer should be placed in a well-ventilated location.
ELite 5, User Manual
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Operation at an altitude above 3000 meters (9800 ft) is not recommended.
1.5 Electrical Requirements
The analyzer should only be operated from a wall outlet meeting these power input
requirements:
• 100-127VAC/200-240VAC; 47Hz to 63Hz
• Power Consumption: maximum 400 VA
Please ensure that the wall outlet is also capable of supplying the power consumption of any
additional devices (such as a printer).
Only the power cord supplied with the instrument should be used. Avoid using extension
cords. The ‘ELite 5’ analyzer comes with a power cord appropriate for your power system.
Proper use of the appropriate power cord assures adequate grounding of the system. If the
power network is not reliable, contact your representative for options such as the installation
of an external UPS module.
Failure to properly ground the ‘ELite 5’ bypasses important safety features
and may result in electrical hazard.
The instrument should not be placed near potentially interfering devices capable of emitting
radio frequencies (e.g. radio or television transmitters/receivers, radars, centrifuges, X-ray
devices, fans, etc.).
This analyzer is designed to be safe for transient voltages to INSTALLATION CATEGORY II
and POLLUTION DEGREE 2.
1.6 Space Requirements
It is important to install the instrument in a suitable location. A poor location can adversely
affect its performance.
Select a well-ventilated location near a power source and close to a suitable drain.
Place the unit on a clean, level surface. Leave at least 0.5 m (18 inches) space on both sides
and above the instrument to access pneumatics. A minimum of 0.2 m (8 inches) must be
maintained between the rear panel and the wall to allow for heat dissipation and tube
clearance.
Ensure there is enough clearance in front of the ‘ELite 5’ analyzer to open the front panel.
Allow enough space if you want to use optional external keyboard, mouse or bar code
reader.
Your selected location should allow placement of the reagents in an unobtrusive location
below the laboratory bench that the instrument is placed on, or on the same surface.
Placement below the laboratory bench also allows for storage of a spare set of reagents.
Never place the reagents above the ‘ELite 5’ analyzer.
See Chyba! Nenalezen zdroj odkazů. and Chyba! Nenalezen zdroj odkazů. for more
information about proper analyzer location and clearance.
ELite 5, User Manual
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Figure 1. ELite 5 with Autosampler Space Requirements
ELite 5, User Manual
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Figure 2. ELite 5 Without Autosampler Space Requirements
1.7 Weight Requirements
The ‘ELite 5’ analyzer weighs 35 Kg (77 lb) without the Autosampler. The ‘ELite 5’ with
optional Autosampler weighs 47Kg (104 lb). Adding an external keyboard, printer etc. can
bring the total weight up to 60 Kg (132 lb). If you decide to store the reagents on the same
surface, then the combined weight can reach 100 Kg (220 lb).
Please select a table, laboratory shelf, or other location which can support the weight of the
‘ELite 5’ with accessories and is free from vibration.
ELite 5, User Manual
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To allow reliable operation and to provide a safe working environment, make
sure that the table supporting the unit is stable enough to carry the weight of
the instrument and accessories.
1.8 Waste Disposal
‘ELite 5’ analyzer waste contains human blood and reagents that are chemically and
biologically active, and should be considered to be a potential infection and biohazard threat.
Safe laboratory practices must be followed including the use of personal protective when
operating the ‘ELite 5’ and handling blood, reagents, and waste.
1.9 Known Limitations
The ‘ELite 5’ is not intended for analysis of animal blood samples. Anti-coagulated and
homogenized human blood samples must be free from contamination.
Blood samples must be analyzed within 12 hours of venipuncture.
1.10 Emergency Situations
Always follow all applicable laws and regulations with regard to emergency situations.
If the ‘ELite 5’ needs to be powered off due to an emergency situation (like fire, thunderstorm
etc.), follow the procedures in chapter 6.3.4.
In case of fire, do not use water to extinguish the fire unless the ‘ELite 5’ is
disconnected from the electrical network!
ELite 5, User Manual
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2 Product Support
Your sales representative is trained and qualified to answer questions about applications and
the operation of the ‘ELite 5’ analyzer. If you have additional questions regarding the ‘ELite
5’, please ask for manufacturer support through your sales representative.
Erba Lachema makes every effort to provide excellent support and up to date information
and services regarding the ‘ELite 5’ analyzer. Software updates and application documents
are available on the Erba Lachema web site at http://www.erbamannheim.com.
ELite 5, User Manual
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3 Installation
Your Erba Lachema certified service engineer will perform the initial installation of the ‘ELite
5’ analyzer and train you and selected laboratory personnel on the proper use and
maintenance of the analyzer. The analyzer should only be operated by properly trained
personnel. You’ll also be explained about necessary maintenance actions.
3.1 Package contents
3.1.1 The ‘ELite 5’ Analyzer Package
After opening the ‘ELite 5’ analyzer packaging, you will find an accessory box. The analyzer
is in a plastic bag in between cushioning protective material. After opening the bag, remove
the desiccant packs. The package should contain the following items:
• ‘ELite 5’ analyzer
• Accessories box on top of the analyzer, containing:
• Power cord
• User Manual (this document)
• Sample tube adapter for the individual sample unit (1 pc)
• Reagent tube kit (in a plastic bag, with special caps)
• Plastic waste container
• Cardboard box for the waste container
• “Preparing for shipment” tube kit
• ‘ELite 5’ analyzer Final Check Report
Please inform your Sales Representative if any item is missing or damaged. Retain the
original ‘ELite 5’ analyzer packaging for future transportation and storage.
3.1.2 The Autosampler Package
The Autosampler is an optional unit that attaches to the ELite 5. If the optional Autosampler
unit was ordered, package should contain the following items:
• Autosampler unit
• Sample tray
• Sample racks -10 pieces
• Autosampler Final Check Report
Please inform your sales representative if any item is missing or damaged. Retain the
original Autosampler packaging for future transportation and storage.
3.1.3 Small Sample Package (optional)
• SSM Micro dilutor front-left frame rail assembly
• Ribbon cable #1 with connectors for the SSM micro dilutor
• SSM valve assembly with connected Tygon tubing
• “T” fitting with attached 3 cm Tygon tube
• 4-way ribbon cable #2 with connectors for the SSM valve assembly
• Pre-dilution chamber plus pre-dilution chamber holder assembly with rubber chamber
protector
• SSM sample rotor plate
• 2 pcs of 3x10 hex screws with washers (used for mounting SSM pre-dilution chamber holder)
• Adhesive cable holder, plastic adhesive tube holder and 2 pcs of plastic tube holders
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• Silicon edge protectors and cable guide tool
3.2 Connecting the reagents
The ‘ELite 5’ is capable to aspirate reagents from 1.2m (~4’). (Measured from the bottom of
the reagent container to the table level where the ‘ELite 5’ is installed.)
You will use 3 input reagents and the 2 waste-output. Select a location close to a suitable
drain. The waste container should be periodically emptied.
You can place the reagent below or on the same level where the ‘ELite 5’ is installed. Do not
place the reagents to a higher location than the bottom of the ‘ELite 5’, because in case of
any tubing problem, valve error etc. the reagent can spill out.
3.3 Power connection
The analyzer should only be operated from a wall out
let meeting general
specifications of power input requirements: 100-127VAC/200-240VAC; 47Hz
to 63Hz
Power Consumption: maximum 400 VA
If the power network is not reliable, contact your representative for options
(e.g. installation of an external UPS module).
Only the power cord supplied with the instrument should be used. Avoid
using extension cords.
Please check the power consumption of the additional devices (printer) as well.
3.4 Connections to the peripherals
If you plan to connect any external devices (printer, host-computer etc.) to ‘ELite 5’ then prior
the installation please check the possible cable paths. If it is necessary then make all the
preparations (cable-channels, cable-binders, drilling trough tables, walls etc.) before the
installation starts.
Although the Windows® XP® Embedded operating system can recognize several peripheral
devices please prepare the installation material provided by the vendor of the device.
3.5 Environmental conditions
The ‘
ELite
5’ is designed for laboratory operation.
Mobile operation is not
supported. Operate ‘ELite 5’ at the ambient temperature within the range of
15-30°C (59-98 °F) and maximum relative humidity of 80%. The optimum
operating temperature is 25°C. Reagents should be stored at a temperature
range of 15-30°C. The ‘ELite 5’ operates properly up to 3000 meters above
sea-level.
Do not place the reagent containers to a higher position than ‘ELite 5’. This
is to avoid unintentional spilling of reagents. The vertical distance between
the reagent container and ‘ELite 5’ must not be more than 120 centimeter.
The instrument should be placed in a well-ventilated location. The instrument should not be
placed near potentially interfering devices capable of emitting radio frequencies (e.g. radio or
television transmitters/receivers, radars, centrifuge, X-ray devices, fans, etc.).
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Operation at an altitude over 3000 meters (9000 ft) is not recommended.
3.6 Visual inspection
To ensure correct operation, and to check that the instrument has been delivered to you
without any damage, please check the following before starting the unit for the first time:
‘ELite 5’:
• The front panel should have no cracks;
• The screen should have no cracks;
• No visible dents or bumps on instrument housing (front, side rear, top cover);
• Open the front panel of the unit:
o The front panel is easy to open and close (see section 15.1);
o Inspect that the syringes are not cracked;
o Check if the shear valve has the safety card installed;
o Check if there are no fluid inside the tubing;
o Check if there are no salt build-ups inside the tubing.
Autosampler:
• No visible dents or bumps on the housing of the Autosampler;
• The transparent cover opens and closes smoothly;
• The sample-tray and the racks have no visible damage.
3.7 Moving to the selected location
Check the presence of all necessary connections.
Move the ‘ELite 5’ to the selected location.
If it is hard to access the back of the ‘ELite 5’ after it is in the final location then connect the
reagent tubes to the ‘ELite 5’ but not to the reagent containers. (For details see chapter 3.2)
Be sure that the main switch (right next to the power connector) is in off position.
3.8 Removing the safety card from the shear valve
In order to prevent the damage of the shear valve during transportation a protective plastic
card is placed between the ceramic disks of the shear valve. Before using the ’ELite 5’
instrument, this card must be removed.
Please perform the following steps:
• Open the cover of the equipment
• Locate the white plastic card in shear valve
• Pull out the card
• Check and tighten the locking screw of the shear valve if necessary
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Figure 3. Shear Valve with plastics card
3.9 Connecting the Autosampler
If the optional Autosampler unit also purchased then:
• Remove the secondary cover-plate from the right-side cover-plate of the ‘ELite 5’;
• Check that the connection surface is clean and there are no blocking objects (like
hanging, swinging cables);
• Push the Autosampler into the ‘ELite 5’ until the clamps are locked.
3.10 Connecting the reagents
If it was not done beforehand than:
• Connect the reagent tubes to the ‘ELite 5’:
o Use the supplied connecting tubes and special bottle caps;
o Be sure that the color on each tube, cap and connector in the back of the
instrument match.
• Connect the reagent containers to the reagent tubes.
The analyzer operates with chemically and biologically active reagents.
Direct (skin) contact with these reagents should be avoided. Please read
reagent descriptions carefully for possible emergency actions. Only original
reagents are usable with ‘ELite 5’, available from Erba Lachema.
Place the reagent containers near the instrument, to an accessible location.
Do not place the containers to a higher position than ‘ELite 5’. This is to
avoid unintentional spilling of reagents.
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4 General Overview and Principles of Operation
4.1 General Overview
The ‘ELite 5’ is a fully automated high quality hematology analyzer for in vitro diagnostic use
in clinical laboratories. It provides precise and accurate 5-part differential measurement using
a laser based optical measurement technology.
The ‘ELite 5’ analyzer uses the impedance method for measurement of leukocytes (WBC),
erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin
(HGB) content of red blood cells is accomplished by photometric measurement technology.
5-part leukocyte differentiation (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished
using optical laser-based flow cytometric technology.
A vivid color touch screen display is featured with an intuitive, informative, and attractive user
interface. A START button allows one-touch operation for ease of use.
The ‘ELite 5’ analyzer’s unique software system supports the use of many commonly used
external printers with its USB connections. The ‘ELite 5’ internal database is capable of
storing 100,000 patient, QC, and calibration result records including flags and graphical
scatter diagrams and histograms. The system software is field-upgradeable to ensure up-todate operation.
An automatic optional Autosampler is available (sold separately) for automated processing
up to 100 sample tubes for increased laboratory efficiency. The system software supports a
variety of flexible LIS download techniques for efficient integration into laboratory workflow.
The ‘ELite 5’ features advanced Ethernet LIS connectivity using the HL7 protocol in addition
to standard serial interfaces, providing the clinical laboratory with flexible connectivity
options.
Small Sample Module (optional) enables to test patient samples having only a small venous
blood volume.
4.1.1 Measured Parameters
‘ELite 5’ determines 26 hematology parameters including 5-part WBC differential. The
instrument requires 110 l of whole blood-sample in closed- and open-vial mode. Cycle time
is 60 seconds.
With SSM (small sample module - optional) 25 µl of venous blood is aspirated in open-vial
mode.
Par
ameter
Symbol
Measurement method
White Blood Cell count WBC Impedance measurement
Lymphocyte count LYM Calculated
Monocyte count MON Calculated
Neutrophil count NEU Calculated
Eosinophil count EOS Calculated
Basophil count BAS Calculated
Lymphocyte percentage LYM% Optical measurement
Monocyte percentage MON% Optical measurement
Neutrophil percentage NEU% Optical measurement
Eosinophil percentage EOS% Optical measurement
Basophil percentage BAS% Optical measurement
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Par
ameter
Symbol
Measurement method
Red Blood Cell count RBC Impedance measurement
Hemoglobin HGB Photometric measurement
Hematocrit HCT Calculated
Mean Corpuscular Volume MCV Derived
Mean Corpuscular Hemoglobin MCH Calculated
Mean Corpuscular Hemoglobin
Concentration
MCHC Calculated
Red Blood cells Distribution Width RDWcv Derived
Red Blood cells Distribution Width RDWsd Derived
Platelet count PLT Impedance measurement
Mean Platelet Volume MPV Derived
Platelet Distribution Width**
(for Research Use Only)
PDWcv Derived
Platelet Distribution Width**
(for Research Use Only)
PDWsd Derived
Thrombocrit**
(for Research Use Only)
PCT Calculated
Large platelet count PLCC PLT count above 12 fl in
size
Large platelet percentage PLCR Calculated
**The PDWcv, PDWsd, and PCT parameters are considered to be for Research
Use Only (RUO), and will be marked on the screen, printout, database, and LIS
transmission.
Table 1. ‘ELite 5’ Analyzer Parameters
4.1.2 Approved Reagents and Control Materials
Always use reagents, control and calibration materials that are recommended and approved
by the manufacturer. The ‘ELite 5’ analyzer, controls, calibrator and reagents are part of a
system and are carefully designed and selected for optimal performance. Using unapproved
reagents or controls may cause false flagging or incorrect, inaccurate results.
Only original Erba Lachema reagents may be used in the ‘ELite 5’ analyzer. For additional
details about these materials, please contact the manufacturer directly.
4.1.3 Original Erba Lachema Reagents
Use only the original Erba Lachema reagents listed below to ensure proper
performance of the ‘ELite 5’ analyzer. Reagents are manufactured and provided by
Erba Lachema s.r.o., and are for in vitro diagnostic use only. For using leave the
reagent at room temperature for at least 12 hours. Do not use reagent once frozen.
Kat. číslo
Název
Objem
HEM00006 Erba Lyse-5P 5 l
HEM00002 Erba Diff-5P 1 l
HEM00005 Erba Hypoclean CC 100 ml
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HEM00003 Erb Dil-5P 20 l
Additional cleaning solutions – use as needed
HEM00017 Erba Clenz 1 l
HEM00016 Erba Hypoclean 1 l
For package insert for reagents and cleaning solutions please see Appendix
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4.2 Principles of Operation
The ‘ELite 5’ analyzer uses a combination of methods to provide measurement results:
• Volumetric impedance (the Impedance method) is used to determine the cellular
concentrations and volume distributions of leukocytes (WBC), erythrocytes (RBC),
and platelets (PLT).
• Photometric measurement of light absorbance is used to determine hemoglobin
(HGB) concentration.
• Optical measurement of light scattering and diffraction is used to determine 5-part
leukocyte (LYM%, MON%, NEU%, EOS%, BAS%) differential parameters.
4.2.1 Volumetric Impedance Method
The volumetric impedance method determines cellular concentrations and volume
distributions of cells by detecting and measuring changes in electrical impedance when
particles suspended in a conductive liquid pass through a small aperture. The method is
“volumetric” because a small known volume of blood is precisely diluted with a conductive
diluent and forced through the aperture at a fixed rate.
Figure 4. Volumetric Impedance Method
A constant direct current flows between the electrodes on either side of the aperture. Each cell
passing through the aperture causes a change in the electrical impedance of the conductive blood
cell suspension. This change is sensed by the ‘ELite 5’ electronics and converted to an electrical pulse.
The quantity of pulses is proportional to the number of particles. The intensity of each pulse is
proportional to the volume of the particle. The volume distribution diagrams of the particles result in
the WBC, RBC, and PLT histograms that measured in femtoliter volume units.
Electronic discrimination allows separation of erythrocytes (RBC) and platelets (PLT). A lytic
reaction lyses erythrocytes to clearly measure leukocytes (WBC).
4.2.2 Photometric Light Absorbance Method
A lysed blood sample dilution can be analyzed for hemoglobin (HGB) concentration based on
its stable chromogen content. The reagent lyses the red blood cells causing the release of
cellular hemoglobin. The hemoglobin concentration is measured by taking a photometric
reading across the ‘ELite 5’ WBC chamber. The HGB measurement is calculated as the
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difference between blank and sample measurement with and without illumination to reduce
the effect of liquid refraction and incident light.
Figure 5. Photometric Light Absorbance Method
4.2.3 Optical Light Scatter and Diffraction Method
Optical measurement of light scattering and diffraction is used to determine 5-part leukocyte
(LYM%, MON%, NEU%, EOS%, BAS%) differential parameters. An optical measuring head
contains a focused laser source that is used to illuminate a stream of leukocytes (WBC)
suspended in an optically clear diluent moving through a flow cell.
The cells scatter light as they flow through the path of the laser beam. An optical detector
senses changes in the intensity of the scattered laser light which are proportional to the cell
volume and granularity of the cell’s internal structure. The ‘ELite 5’ electronics convert these
changes to electrical pulses which are gathered and stored for analysis. Five part population
discrimination is based on analysis of the two dimensional volume and granularity distribution
scatter diagram.
Figure 6. ‘ELite 5’ Optical Head Block DIagram
Cells with greater volume or size or more granularity will tend to scatter greater amounts of
light. The intensity of scattered light is detected by an optical signal processing system.
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Figure 7. Optical Signal Processing System
External structure (and the size of the cell) causes lower angles of scatter, and internal
granularity or complexity causes higher angles of diffraction. Both low and high angles of
light scatter are captured by optical sensors, providing the ‘ELite 5’ analyzer with two
independent measurements for each cell crossing the path of the laser beam.
Figure 8. Cellular Light Scatter
The light scatter data are gathered and plotted as a two dimensional scatter diagram. Similar
cells have similar scatter characteristics and tend to group together. This allows the
analytical software to differentiate and identify the leukocyte populations and generate the
4DIFF and BASO scatter diagrams.
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Figure 9. 4DIFF Scatter Diagram
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Inside the ‘ELite 5’ Analyzer
4.2.4 Front Panel
The touch screen display is the primary user interface
of ‘ELite 5’ analyzer for user interactions and data
entry. The LCD screen can be cleaned with a damp
sponge and gentle detergent.
The front panel is a hinged cover that provides easy
access to the shear valve, sampling needle and
syringes for cleaning and maintenance. The front
panel, START button, and the sample rotor can be
cleaned with a damp sponge and ethanol or
isopropanol.
Sample tube is placed into a tube adapter inserted on
the sample rotor for closed vial or open vial singletube manual sample processing. The sample tube is
rotated from the front of the unit into the inside of the
‘ELite 5’ for aspiration. This safety feature protects
the operator from inadvertent contact with the
aspiration needle during specimen processing.
Automatic sample processing with the optional Autosampler can be interrupted in order to
run one or more stat samples with the sample rotor. Automatic processing can be resumed
after stat sample processing is complete.
The START button allows easy one-hand operation of the ‘ELite 5’ analyzer. The color of the
START button indicates the status of the ‘ELite 5’ analyzer:
Green - ready to process samples
Red – busy
Orange - standby mode.
4.2.5 Back Panel
Power connector: the ‘ELite 5’ power connector should be
connected to a grounded power outlet that meets the
requirements listed in section 1.5.
Main power switch: this is a small switch located next to the
power connector. This switch turns off all electrical power to the
‘ELite 5’ analyzer. Leaving this switch on allows the ‘ELite 5’ to
remain in the standby mode. The switch is on when it is in the
‘up’ position labeled ‘1’ and is off when it is in the down position
labeled ‘0’.
Standby switch: flipping this switch to the ‘up’ position takes
the ‘ELite 5’ main computer out of the standby state and
powers up internal analyzer components. Please note that this
switch springs back to the down position when released and
does not stay in the ‘up’ position.
Figure
10
. Elite 5 Front Panel
1
2
3
4
5
6
Start button
Touch screen
Sample rotor
Place for
autosampler
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Hardware key connector: this connection is used to plug in the hardware key supplied with
every new package of original Erba Lachema Erba•Lyse-5P reagent. A new reagent key
provides the analyzer with the ability to run 800 measurements. When the measurement
count has been exhausted, the ‘ELite 5’ analyzer stops processing samples.
Reagent connectors: five color-coded tubing connectors provide connection to the
reagents. There are three reagent connectors and two waste connectors.
Green
1
connector
Erba•Dil-5P diluent
Orange
1
connector
Erba•Diff-5P
Yellow
1
connector
Erba•Lyse-5P
Red
2
connectors
Waste
Main board back panel I/O Ports: these are the back panel computers of the ‘ELite 5’
analyzer main computer board. They provide standard connection to peripherals such as
external keyboard and mouse, printers, bar code readers.
Avoid getting liquids on the electrical connectors. The rear panel of the analyzer should
be cleaned with a cloth or sponge with 70% ethanol
1 PS2 Mouse port for optional mouse
1 PS2 Keyboard for optional PS2
keyboard
1 COM port for LIS
2 RJ45 Ethernet port for LIS
1 VGA port (unused)
4 USB 2.0 ports for peripherals
3 Audio jacks (unused)
Figure 12. Main Board Back Panel I/O Ports
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4.2.6 Left Side Assembly
To access the left or right side assemblies, the side panels must be removed. Please refer to
section 15.1.2 for information about removing the side panels.
Pressure Sensors
Small Measure Buffer
Drain Buffer,
Mix, RBC & WBC
Chambers
Valves 1-22
Valves 23-44
Diluent Buffers
Diff-5p, Lyse-5p Buffer s
Sheath Buffer
Figure 13. Left Side Assembly
• Pressure sensors measure the differential pressures of vacuum buffer for
impedance base and optical measurement and empty chamber process.
• Small Measure buffer is a vacuum buffer used for impedance measurement.
• Sheath buffer is a reservoir for Erba•Dil-5P diluent for optical measurements.
• Diff-5P buffer is a reservoir for Erba•Diff-5P reagent.
• Lyse-5P puffer is a reservoir for Erba•Lyse-5P reagent.
• Diluent buffers are reservoirs for Erba•Dil-5P diluent.
• Valves 1-44 connect pneumatic components to carry out dilution, reaction,
measurement, and waste disposal processes.
• Drain buffer controls chamber draining procedures.
• Mix chamber performs the first step of RBC dilution.
• RBC chamber performs the second step of RBC dilution and contains the RBC
aperture.
• WBC chamber performs the WBC dilution and holds the WBC aperture and HGB
photometric measurement system.
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