abx pentra 60-c plus analyzer - service manual

Pentra 60C+

P/n: RAA021B

Technical Manual

ABX DIAGNOSTICSB.P. 7290Rue du caduceParc Euromdecine34184 MONTPELLIER Cedex 04 - FRANCE

(Pentra 60 C+

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Copyright 2004 by ABX DIAGNOSTICS All rights reserved. No part of this book may be reproduced or transmitted in any form orby any means, electronic, mechanical, photocopying, recording, or otherwise, without theprior written permission of ABX DIAGNOSTICS.

Trademarks Microsoft and Windows are registered trademarks of Microsoft corporation.

Other product names mentioned within this publication may be trademarks or registeredtrademarks of other companies.

Notice of Liability The information in this manual is distributed on an as is basis, without warranty. Whileevery precaution has been taken in the preparation of the manual, ABX DIAGNOSTICS will notassume any liability to any persons or entities with respect to loss or damage, caused oralleged to be caused directly or indirectly by the instructions contained in this manual or bythe computer software and hardware products described herein.

Graphics All graphics including screens and printouts, photographs are for illustrations purposesonly and are not contractual.

III

Introduction

REVISIONS

INDEX TECHNICAL NOTE SOFTWARE REVISION SECTION DATEA RAH801A V1.61 ALL 14/04/2001B RAN038A V2.2.9 ALL 15/02/2004

This document applies to the latest higher software version.

When a subsequent software version changes the information in this document, a new issue will be released.

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1. WARNINGS AND PRECAUTIONS

User manual must be enterely read and personnel trained by ABX DIAGNOSTICS beforeattempting to operate instrument. The user always operates with full knowledge andappreciation of instrument warnings, alarms and flags.Always refer to labeling and ABX DIAGNOSTICS instructions in order to avoid to compromisesystem integrity.

The ABX PENTRA 60 C+ responds to the Standards and directives named in the Declarationof Conformity added at the beginning of this manual.

The reagents and accessoiries stipulated by ABX DIAGNOSTICS have been validated inaccordance with the European Directive for in-vitro medical devices (98/79/CE).

The use of any other reagents and accessoiries may place at risk the performance of theinstrument, engaging the Users reponsability. In this case, ABX DIAGNOSTICS takes noresponsability for the device nor for the results rendered.

Disposal gloves, eyes protection and lab coat must be worn by the operator. Local ornational regulations must be applied in all the operations.

Portable/mobile should not be used in proximity

All peripheral devices should be IEC compatible.

1.1. Warnings

WARNING: Flags a procedure that if not followed properly, can prove to be extremelyhazardous to either the operator or the environment or both.

NOTENOTE: Emphasizes the important information especially helpful to the operator before, duringor after a specific operational function.

IMPORTANT

CAUTION

WARNING

CAUTION: Emphasizes an operating procedure that must be followed to avoid possibledamage to the instrument or erroneous test results.

IMPORTANT: Emphasizes an operating procedure that must be followed to avoid erroneousresults.

VIntroduction

The following parts must not be handled or checked by the user:- Electrical power supply,- Electronic components.

Operator injury may occur from an electric shock. Electronic components can shock andinjure the user. Do not tamper with the instrument and do not remove any components(covers, doors, panels and so on) unless otherwise instructed within this document.

Danger ! The battery may explode if it is not replaced correctly ! Replace only with thesame or equivalent type recommanded by the manufacturer. Dispose of used batteriesaccording to the manufacturers instructions.

Moving parts:It is strictly forbidden to disable sensors as it may cause operator injuries. Protection coversmust not be opened during instrument operations.

If this instrument has been supplied to you by anyone other than ABX

Diagnostics or an authorised representative, ABX Diagnostics cannot

guarantee this product in terms of specification, latest revision and latest

documentation. Further information may be obtained from your

authorised representative.

CAUTION

The duration of guarantee is stipulated in the Sales conditions associated with the purchaseof this instrument. To validate the guarantee, ensure the following is adhered to:

1 - The system is operated under the instructions of this manual.

2 - Only software or hardware specified by ABX DIAGNOSTICS is installed on the instrument.This software must be the original copyrighted version.

3 - Services and repairs are provided by an ABX DIAGNOSTICS authorized technician, usingonly ABX DIAGNOSTICS approved spare parts.

4 - The electrical supply of the laboratory follows the national regulations.

5 - Specimens are collected and stored in normal conditions.

6 - Reagents used are those specified in this user manual.

7 - Proper tools are used when maintenance or troubleshooting operations are performed.

1.2. Limited garantee

1.3. Safety precautions, electronic and moving parts

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Consider all Specimens, Reagents, Calibrators, Controls, etc that contain human bloodor serum as potentially infectious! Use established, good laboratory working practices whenhandling specimens. Wear protective gear, Gloves, Lab coats, Safety glasses and/or Faceshields, and follow other bio-safety practices as specified in OSHA Blood borne PathogensRule (29 CFR part 1910. 1030) or equivalent bio-safety procedures.

ABX DIAGNOSTICS uses disinfectant product for instrument decontamination and highlyrecommends it to decontaminate your instrument.

1.4. Biological risks

Instrument external cleaning The external surfaces of the instrument must be decontaminated considering the biologicalenvironment.

1.5. Instrument cleaning

WARNINGNever spill liquid on the instrument.

Never use Disinfectant product* that contains alcohol.

Computer screen: Use a soft clot, slightly wet with disinfectant product*. Wipe gently thescreen and dry to remove any trace of moisture.

All contaminated surfaces (covers, counting assembly area...): Slightly wet a sponge withdisinfectant product* and wipe the dirty surfaces.

Stainless steel parts: Slightly wet a sponge with disinfectant product* and wipe the dirtysurfaces. Dry with a soft cloth.

*Products having the following microbiological properties: Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis (B.K) Antiviral (VIH, HBV and rotavirus)

Product Example validated by ABX DIAGNOSTiCS:ANIOS detergent disinfectant ; WIPANIOS ; ref: 1316.424

NOTEPlease also refer to the W.H.O (World Health Organization) guidelines:

Laboratory Biosafety Manual, 2nd edition, for further information.

VII

Introduction

Instrument internal cleaning Concentrated cleaning: Counting chambers and hydraulics parts are decontaminated byusing the Concentrated cleaning function as described in 2.1.2. Concentrated cleaning,page 5-11.

Sampling probe Sampling probe must be decontaminated as follows:

1- Prepare a solution of Sodium Hypochlorite to 100ml/l.

2- Fill a 5ml tube with this solution.

3- Run 5 analysis on bleach.

NOTEPlease also refer to the W.H.O (World Health Organization) guidelines:

Laboratory Biosafety Manual, 2nd edition, for further information.

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VIII

Alternating current

1.6. Graphics and symbols

Switch off position Switch on position

Manufacturer

In Vitro Diagnostics medical deviceThis product conforms to the EEC Stan-dards and Directives named in thedeclaration of conformity

Caution, consult accompanyingdocuments

Biological risk

Reagent Up

Fragile, handle with care Keep dry

Do not stack Temperature limitation

Batch code Catalogue number

Use by Consult Instructions for use

Calibrator Control

Content

IX

Introduction

2. WORKING CONDITIONS

2.1. Environment

The operation of the ABX PENTRA 60 C+ should be restricted to indoor location use only !Operation of the instrument at altitudes of over 3000 Meters (9800 feet) is not recommended.The instrument is designed for safety from voltages surges according to INSTALLATIONCATEGORY II and POLLUTION DEGREE 2(IEC EN 61010-1).Please contact your local ABX DIAGNOSTICS representative for information regarding operationlocations, when it does not comply with the recommended specifications.

2.2. Location

The ABX PENTRA 60 C+ should be placed on a clean and levelled table or workbench. Pleasenote that the ABX PENTRA 60 C+, printer and reagents weigh approximately 40 kilograms (88lbs).Avoid exposure to sunlight.Place your instrument where it is not exposed to water or vapor.Place your instrument where it is free from vibration or shock.Place your instrument where an independent power receptacle can be used.Use a receptacle different from the one used by a device that easily generate noise such asa centrifuge, etc...

Provide a space of at least 20 cm (8 inches) at the back of the instrument for arranging thepower cable and tubings.

The Power switch and Input voltage supply connection should always be accessible !When positioning the system for operational use, leave the required amount of space foreasy accessibility to these items.

2.3. Grounding

Proper grounding is required when installing the system. Check the wall outlet ground(Earth) for proper grounding to the facilities electrical ground. If you are unsure of the outletgrounding, contact your facilities engineer to verify the proper outlet ground !

2.4. Humidity and temperature conditions

ABX PENTRA 60 C+ must operate between temperatures of 16 to 34C (61 to 93F). Maxi-mum relative humidity should be 80% for temperatures up to 31C (88F) and decreasinglinearly to 50% relative humidity at 40C (104F). If the system is kept at a temperature of10C (50F) or less, it must be allowed to sit at room temperature for 1 hour before it can beused for operation.

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2.5. Electromagnetic environment check

The ABX PENTRA 60 C+ has been designed to produce less than the accepted level ofelectromagnetic interference in order to operate in conformity with its destination, allowingthe correct operation of other instruments also in conformity with their destination.In case of suspected electromagnetic noise, check that the instrument has not been placedin the proximity of electromagnetic fields or short wave emissions, i. e. (Radar, X-rays, Scan-ners, Cell phones, etc...).

2.6. Environment protection

Disposal Used accessories and consumables must be collected by a laboratory specializedin elimination and recycling of this kind of material according to the local legislation.

Disposal ABX PENTRA 60 C+ instrument:It should be disposed of, in accordance with local legislation, and should be treated as beingcontaminated with blood. The appropriate biological precautions should be taken.

2.7. Transport and storage conditions

Storage temperature: -20C +50C

Prior to the shipping of an instrument by transporter, whatever

the destination, an external decontamination of the instrument

must be carried out.

XI

Introduction

INTRODUCTION

REVISIONS ........................................................................................................ III

1. WARNINGS AND PRECAUTIONS .................................................................. IV1.1. Warnings ................................................................................................ IV1.2. Limited garantee .................................................................................... V1.3. Safety precautions, electronic and moving parts ................................... V1.4. Biological risks ....................................................................................... VI1.5. Instrument cleaning ............................................................................... VI1.6. Graphics and symbols ......................................................................... VIII

2. WORKING CONDITIONS .............................................................................. IX2.2. Location................................................................................................ IX2.3. Grounding ............................................................................................. IX2.1. Environment .......................................................................................... IX2.4. Humidity and temperature conditions ................................................... IX2.5. Electromagnetic environment check ..................................................... X2.6. Environment protection ......................................................................... X2.7. Transport and storage conditions .......................................................... X

SPECIFICATIONS............................................................................................. XII

HYDRAULIC & PNEUMATIC PRINCIPLES ........................................................XIII

ELECTRIC & ELECTRONIC PRINCIPLES ......................................................... XIV

ANALYSIS CYCLE TECHNOLOGY ................................................................... XV

SOFTWARE VERSIONS................................................................................... XVI

OUTPUT FORMAT ......................................................................................... XVII

ALARMS & ERROR LIST ............................................................................... XVIII

MAINTENANCE .............................................................................................. XIX

EXPLODED VIEWS .............................................................. XX

SPARE PART LIST .......................................................................................... XXI

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SPECIFICATIONS

1. TECHNICAL SPECIFICATIONS .................................................................... 1-21.1. Parameters .......................................................................................... 1-2

1.1.1. CBC Mode .................................................................................................. 1-21.1.2. CBC + 5DIFF Mode ..................................................................................... 1-3

1.1.3. Units.................................................................................................. 1-41.2. Throughput Analyses .......................................................................... 1-51.3. Tube Identification ............................................................................... 1-51.4. Reagents ............................................................................................. 1-51.5. Workstation Computer ........................................................................ 1-51.6. Measurements and computation ........................................................ 1-5

2. PHYSICAL SPECIFICATIONS ...................................................................... 1-62.1. Power requirements ............................................................................ 1-62.2. Operating temperature and humidity .................................................. 1-62.3. Dimensions and Weight ...................................................................... 1-62.4. Minimum specimen volume ................................................................ 1-62.5. Dilution ratios ...................................................................................... 1-72.6. Hgb measurement ............................................................................. 1-72.7. Counting aperture diameters .............................................................. 1-72.8. Reagent consumption (ml) ................................................................. 1-8

3. SUMMARY OF PERFORMANCE DATA ....................................................... 1-93.1. Precision (Reproducibility)* .................................................................. 1-93.2. Precision (Repeatability) .................................................................... 1-10

Precision claims* ............................................................................................... 1-103.2. Linearity* ............................................................................................. 1-113.3. Carryover* .......................................................................................... 1-113.4. Normal ranges* ................................................................................. 1-123.5. Accuracy* .......................................................................................... 1-133.6. Leukocyte differential count ............................................................... 1-133.7. Sample stability study ........................................................................ 1-133.8. Flags giving an analysis default .......................................................... 1-14

4. REAGENTS SPECIFICATIONS .................................................................... 1-154.1. Reagent specifications ....................................................................... 1-154.2. Waste handling precautions .............................................................. 1-15

5. LIMITATIONS ............................................................................................. 1-165.1. Maintenance ...................................................................................... 1-165.2. Blood specimens ............................................................................... 1-165.3. Known interfering substances ........................................................... 1-17

XIII

Introduction

HYDRAULIC & PNEUMATIC PRINCIPLES

1. HYDROPNEUMATIC CONNECTIONS ..........................................................2-2

2. FUNCTION OF VALVES ..............................................................................2-5

3. VALVES LOCATIONS ..................................................................................2-6

4. PNEUMATIC DIAGRAM .............................................................................. 2-7

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ELECTRIC & ELECTRONIC PRINCIPLES

1. MAIN BOARD TEST POINTS .......................................................................3-2

2. MAIN BOARD POTENTIOMETERS ..............................................................3-4

3. PENTRA 60 C+ BOARDS ............................................................................3-53.1 Main board XAA 425 C .........................................................................3-53.2. Optical Preampli board XAA 423 B .....................................................3-63.3. Motor relay board XAA 427 B ............................................................. 3-73.4. Carriage board XAA 428 C .................................................................3-83.5. LED board XAA 429 A .........................................................................3-9

4. PENTRA 60 C+ CONNECTORS ................................................................ 3-104.1. Chamber Heating Connector XBA 386 A .......................................... 3-104.2. Reagent Heating Coil Connector XBA 387 A ..................................... 3-114.3. Horizontal Carriage Motor XBA 391 A ............................................... 3-124.4. Upper Fan XBA 393 A ....................................................................... 3-134.5. IR sensor XBA 394 AS ...................................................................... 3-144.6. IR sensor XBA 395 AS ...................................................................... 3-154.7. IR sensor XBA 396 AS....................................................................... 3-164.8. IR sensor XBA 397 AS....................................................................... 3-174.9. RBC / WBC coaxe XBA 398 B .......................................................... 3-184.10. LMNE flowcell coaxe XBA 399 AS ................................................... 3-194.11. Barcode reader cable XBA 402 AS ..................................................3-204.12. Diluent level sensor XDA 605 AS ..................................................... 3-21

5. PENTRA 60 C+ SYNOPTIC .......................................................................3-22

XV

Introduction

ANALYSIS CYCLE TECHNOLOGY

1. ANALYSIS CYCLE DESCRIPTION ................................................................2-2

2. MEASURING PRINCIPLES ..........................................................................2-42.1. Multi Distribution Sampling System (MDSS) .........................................2-42.2. RBC / Plt detection principles .............................................................2-52.3. Hgb measurement .............................................................................2-62.4. Hct measurement............................................................................... 2-72.5. RDW calculation.................................................................................. 2-72.6. MCV, MCH, MCHC calculation ............................................................ 2-72.7. MPV Measurement .............................................................................2-82.8. Pct calculation ....................................................................................2-82.9. PDW calculation ..................................................................................2-82.10. WBC and differential count ................................................................2-9

2.10.1. General principles .................................................................................... 2-92.10.2. BASO / WBC Count ................................................................................ 2-92.10.3. LMNE matrix .......................................................................................... 2-10

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SOFTWARE VERSIONS

1. SERVICE SOFTWARE OVERVIEW ...............................................................5-2

2. SOFTWARE RELEASES ..............................................................................5-32.1. Software releases table .......................................................................5-32.2. Software modifications .......................................................................5-3

XVII

Introduction

OUTPUT FORMAT

Refer to document ABX Diagnostics OUTPUT FORMAT RAA024 7-1

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XVIII

ALARMS & ERROR LIST

1. TRANSMISSION .......................................................................................... 7-2

2. DATABASE ................................................................................................. 7-2

3. WORKLIST ................................................................................................. 7-2

4. CALIBRATION ............................................................................................ 7-3

5. TECHNICAL OPERATIONS ......................................................................... 7-3

6. PRINTER .................................................................................................... 7-3

XIX

Introduction

MAINTENANCE

1. MAINTENANCE ..........................................................................................8-21.1. Introduction..........................................................................................8-21.2. Daily customer maintenance ...............................................................8-21.3. Weekly customer maintenance ...........................................................8-21.4. Maintenance table ...............................................................................8-3

2. MAINTENANCE KITS ..................................................................................8-42.1. 6 month maintenance kit .....................................................................8-42.2. Yearly maintenance kit ........................................................................8-42.3. Pistons maintenance kit ......................................................................8-52.4. Fitting kit .............................................................................................8-52.5. Screws kit ...........................................................................................8-6

3. PROCEDURES............................................................................................ 8-73.1. Required tools and product ................................................................. 8-73.2. Procedure chart table .........................................................................8-83.3. Procedure chart table in maintenance order ......................................8-9

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EXPLODED VIEWS

XXI

Introduction

SPARE PART LIST

SPARE PART LIST ......................................................................................... 11-2

Pentra 60 C+SPECIFICATIONS

1. TECHNICAL SPECIFICATIONS ................................................. 1-21.1. Parameters ....................................................................... 1-2

1.1.1. CBC Mode ................................................................ 1-21.1.2. CBC + 5DIFF Mode ................................................... 1-3

1.1.3. Units .............................................................................. 1-41.2. Throughput Analyses ....................................................... 1-51.3. Tube Identification ............................................................ 1-51.4. Reagents ......................................................................... 1-51.5. Workstation Computer..................................................... 1-51.6. Measurements and computation ..................................... 1-5

2. PHYSICAL SPECIFICATIONS ................................................... 1-62.1. Power requirements ........................................................ 1-62.2. Operating temperature and humidity .............................. 1-62.3. Dimensions and Weight .................................................. 1-62.4. Minimum specimen volume ............................................ 1-62.5. Dilution ratios .................................................................. 1-72.6. Hgb measurement .......................................................... 1-72.7. Counting aperture diameters........................................... 1-72.8. Reagent consumption (ml) .............................................. 1-8

3. SUMMARY OF PERFORMANCE DATA .................................... 1-93.1. Precision (Reproducibility)* .............................................. 1-93.2. Precision (Repeatability) ................................................. 1-10

Precision claims* .............................................................. 1-103.2. Linearity* ........................................................................ 1-113.3. Carryover* ...................................................................... 1-113.4. Normal ranges* .............................................................. 1-123.5. Accuracy* ...................................................................... 1-133.6. Leukocyte differential count ........................................... 1-133.7. Sample stability study ..................................................... 1-133.8. Flags giving an analysis default ...................................... 1-14

4. REAGENTS SPECIFICATIONS ................................................ 1-154.1. Reagent specifications.................................................... 1-154.2. Waste handling precautions ........................................... 1-15

5. LIMITATIONS.......................................................................... 1-165.1. Maintenance ................................................................... 1-165.2. Blood specimens ........................................................... 1-165.3. Known interfering substances ........................................ 1-17

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1-2

1. TECHNICAL SPECIFICATIONS

The ABX PENTRA 60 C+ is a fully automated hematology analyzer used for in vitro diagnostic

testing of whole blood specimens. A control station (or workstation) is directly connected to

the instrument.

The ABX PENTRA 60 C+ is able to operate either in CBC mode (Cell Blood Count:12 parameters)

or in CBC + 5DIFF mode (5 population Differential count: 26 parameters).

1.1. Parameters

1.1.1. CBC Mode

WBC White Blood Cell

RBC Red Blood Cell

Hgb Hemoglobin concentrationHct HematocritMCV Mean Corpuscular Volume

MCH Mean Corpuscular HemoglobinMCHC Mean Corpuscular Hemoglobin ConcentrationRDW Red Distribution Width

Plt Platelets

PDW * Platelet Distribution WidthMPV Mean Platelet VolumePct * Plateletcrit

* PDW and PCT have not been established as indications for this product,in the Uni-

ted States. The use of PCT and PDW should be restricted to research and

Investigational measurements only.

1-3

Specifications

1.1.2. CBC + 5DIFF Mode

WBC White Blood CellLYM Lymphocytes % and #

MON Monocytes % and #NEU Neutrophils % and #EOS Eosinophils % and #

BAS Basophils % and #LIC * Large Immature Cell % and #ALY * Atypical Lymphocyte % and #

RBC Red Blood Cell

Hgb Hemoglobin concentrationHct HematocritMCV Mean Corpuscular Volume

MCH Mean Corpuscular HemoglobinMCHC Mean Corpuscular Hemoglobin ConcentrationRDW Red Distribution Width

Plt Platelets

PDW * Platelet Distribution WidthMPV Mean Platelet VolumePct * Plateletcrit

* PCT, PDW, ALY and LIC have not been established as indications for this product,in

the United States. The use of PCT, PDW, ALY and LIC should be restricted to research

and Investigational measurements only.

Pentra 60 C+

1-4

UNITSWBC RBC HGB HCT PLT MCV

STD 103/mm3 106/mm3 g/dl % 103/mm3 m3

SI 109/l 1012/l g/l l/l 109/l flmmol/l 109/l 1012/l mmol/l l/l 109/l flJAPAN 102/mm3 104/mm3 g/dl % 104/mm3 m3

MCH MCHC RDW MPV PCT PDWSTD pg g/dl % m3 % %SI pg g/l % fl 10-2/l %mmol/l fmol mmol/l % fl 10-2/l %JAPAN pg g/dl % m3 % %

LYC LYC MON MON NEU NEU EOSSTD % # % # % # %SI % # % # % # %mmol/l % # % # % # %JAPAN % # % # % # %

EOS BAS BAS ALY ALY LIC LICSTD # % # % # % #SI # % # % # % #mmol/l # % # % # % #JAPAN # % # % # % #

1.1.3. Units

To select the set of units refers to Chapter 4. Instrument configuration

1-5

Specifications

Impedance for WBC, Plt, RBC, BASO. Photometry for Hgb. Impedance and light scattering for LYM, MON, NEU, EOS, ALY and LIC. Computation from stored data that was directly measured for Hct, MCV, MCH, MCHC,RDW, MPV, Pct, PDW.

1.2. Throughput Analyses

CBC Mode (CBC): .............. 60/h CBC + 5DIFF Mode (DIF): .. 60/h

1.3. Tube Identification

By means of the ABX WORKSTATION: Barcode labels or keyboard.

1.4. Reagents

1.5. Workstation Computer

Processor frequency: ......... * Pentium II 350 Mhz (min.) Memory capacity: .............. * 128 Mb (min.) Hard drive: .......................... * 4 Gb (min.) Floppy + CD-ROM Keyboard: ........................... * 105 keys (Qwerty default or Option) Mouse: ............................... * Standard PS/2 compatible RS232 port: ........................ * x2 (Analyser/Local network) Screen: ............................... * 15 monitor (800x600 min.) Operating System: ............. * Microsoft Windows NT 4.0 Service pack 4 GB or US

1.6. Measurements and computation

ABX DILUENT (20 litres) ABX CLEANER (1 litre, Integrated), ABX EOSINOFIX (1litre, Integrated), ABX BASOLYSE II (1 litre, Integrated), ABX ALPHALYSE or BIOLYSE (0.4 litre, Integrated)

Pentra 60 C+

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2. PHYSICAL SPECIFICATIONS

2.1. Power requirements

Power supplies: ................. * from 100Vac to 240Vac (+10%).................................. * 50 Hz to 60 Hz

Power Consumption: ......... * Analyzer and computer: 400 VA.................................. * Printer (Depends on printer see Printers manual).................................. * EPSON EPL5900: 900 VA

2.2. Operating temperature and humidity

16 - 34C (61 - 93F) room temperature

Maximum relative humidity 80% for temperatures up to 31C (88F) decreasing linearly to50% relative humidity at 40C (104F).

2.3. Dimensions and Weight

Analyzer dimensions: ......... * Height: approximately 516 mm (20.3 in.).................................. * Width: approximately 444 mm (17.5 in.).................................. * Depth: approximately 481 mm (19 in.)

Analyzer weight: ................. * approximately 35Kgs (77lbs)

Computer dimensions: ....... * See computers manual Computer weight: .............. * See computers manual

2.4. Minimum specimen volume

CBC Mode (CBC): .............. * 30l CBC + 5DIFF Mode (DIF): .. * 53l

1-7

Specifications

2.5. Dilution ratios

WBC/BASO ........................ * 1/200 LMNE ................................. * 1/80 RBC/Plt .............................. * 1/10 000 Hgb .................................. * 1/250

2.6. Hgb measurement

Hgb chamber, LED 555 nm. Modified Drabkin method (cyanmethemoglobin)

Light source ....................... * Electroluminescent diode Wavelength ........................ * 550nm + 10nm

2.7. Counting aperture diameters

WBC/BASO ........................ * 80 m LMNE ................................. * 60 m RBC/Plt .............................. * 50 m

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2.8. Reagent consumption (ml)

CYCLE REAGENT APPROXIMATEDILUENT BASOLYSE II CLEANER EOSINOFIX ALPHALYSE DURATION

CBC (CBC) 22.6 2.1 0.9 X 0.4 60

5DIFF (DIF) 28.5 2.1 0.9 1 0.4 60Startup* 65.4 2.1 3.7 1 1.4 450Shutdown 27 X 14 X 1 300

Diluent Prime 44.9 X X X X 310Cleaner Prime X X 24.8 X X 120Eosinofix Prime X X X 23.6 X 110

Basolyse II Prime X 23.6 1.1 X X 220Alphalyse Prime 2.1 X X X 8.4 130All Reagents Prime 49 24 25.1 24 8.2 6

Autoclean 13.4 1 1 1 0.3 135Autocontrol 25.4 X 1.4 X 1 150

* for one background count only (maxi = 3)

1-9

Specifications

3. SUMMARY OF PERFORMANCE DATA

3.1. Precision (Reproducibility)*

The ABX PENTRA 60 C+ was initially calibrated with Minocal Calibrator (Lot No. CX322, ExpiryDate: 05-Aug-2002).

Three levels of ABX MINOTROL material (Lot No: JX108) were run in duplicate once dailyfor a prolonged period (26th July 2002 to 30 August 2002) on all parameters.The results were used to quantify within run precision, and Total Precision in accordancewith the NCCLS EP 5-A Guidelines.

PARAMETER ABX MINOTROL WITHIN RUN SD OF RUN SD OF DAILY TOTALCONTROL SD MEANS MEANS PRECISION (SD)

JX108 Low 0.001 N/A N/A 0.001

WBC JX108 Normal 0.008 N/A N/A 0.013JX108 High 0.031 N/A N/A 0.045JX108 Low 0.000 N/A N/A 0.000

RBC JX108 Normal 0.001 N/A N/A 0.001JX108 High 0.002 N/A N/A 0.003JX108 Low 0.001 N/A N/A 0.001

HGB JX108 Normal 0.002 N/A N/A 0.007JX108 High 0.005 N/A N/A 0.012JX108 Low 0.021 N/A N/A 0.025

HCT JX108 Normal 0.064 N/A N/A 0.122JX108 High 0.104 N/A N/A 0.181JX108 Low 6.271 N/A N/A 20.646

PLT JX108 Normal 40.229 N/A N/A 72.103JX108 High 154.146 N/A N/A 381.388

*Source: 510K submission K030144

PARAMETER ABX MINOTROL WITHIN RUN CV% OF RUN CV% OF DAILY TOTALCONTROL CV% MEANS MEANS PRECISION (CV%)

JX108 Low 1.8 N/A N/A 1.93WBC JX108 Normal 0.9 N/A N/A 1.12

JX108 High 0.9 N/A N/A 1.05

JX108 Low 0.8 N/A N/A 0.86RBC JX108 Normal 0.6 N/A N/A 0.79

JX108 High 0.7 N/A N/A 0.88

JX108 Low 0.4 N/A N/A 0.57HGB JX108 Normal 0.3 N/A N/A 0.59

JX108 High 0.4 N/A N/A 0.60

JX108 Low 0.9 N/A N/A 0.99HCT JX108 Normal 0.7 N/A N/A 0.97

JX108 High 0.7 N/A N/A 0.89

JX108 Low 3.1 N/A N/A 5.69PLT JX108 Normal 2.6 N/A N/A 3.46

JX108 High 2.5 N/A N/A 4.01

Pentra 60 C+

1-10

Based on 10 consecutive samples of the same fresh whole blood sample without alarm:

PARAMETERS %CV TEST LEVELWBC

1-11

Specifications

PARAMETER LINEARITY LINEARITY VISIBLE DIFFERENCERANGE LIMITS RANGE

WBC (103/L) 0.40 130.80 0 120 120 150 0.3 7%

RBC (106/L) 0.23 9.76 0 8.00 8.00 18.00 0.07 2%HGB (g/dL) 0.00 31.06 0 24 24 30 0.3 2%HCT (%) 1.80 88.90 0 67 67 80 2.0 3%PLT (103/L) 3.30 2007 0 1900 1900 2800 10 10%

(Hgb>2g/dL,RBC>0.5x106/L)

PLT (103/L) 7.00 - 2895 0 2800 2800 3200 10 10%(Hgb

Pentra 60 C+

1-12

Carry-over Conclusion:Results provided are extremely satisfactory. In order to provide for eventual possibilitieswithin the laboratory environment the following claims shall be made :

WBC RBC HGB PLT

Claims < 2.0% < 2.0% < 2.0% < 2.0%


3.4. Normal ranges*

PARAMETERS MALE FEMALEWBC (103/L) 4 - 10 4 - 10

RBC (106/L) 4.50 - 6.50 3.80 - 5.80HGB (g/dL) 13.0 - 17.0 11.5 - 16.0HCT (%) 40.0 - 54.0 37.0 - 47.0

MCV (m3) 80 - 100 80 - 100MCH (pg) 27.0 - 32.0 27.0 - 32.0MCHC (g/dL) 32.0 - 36.0 32.0 - 36.0

RDW (%) 11.0 - 16.0 11.0 - 16.0PLT (103/L) 150 - 500 150 - 500MPV (m3) 6 - 11 6 - 11

PCT (%) 0.15 - 0.50 0.15 - 0.50PDW (%) 11 - 18 11 - 18NEU (%) 50 - 80 50 - 80

LYM (%) 25 - 50 25 - 50MON (%) 2 - 10 2 - 10EOS (%) 0 - 5 0 - 5

BAS (%) 0 - 2 0 - 2

Expected values will vary with sample population and/or geographical

location. It is highly recommended that each Laboratory establish its

own Normal ranges based upon the local population!

IMPORTANT

*Bibliography:AIDE MEMOIRE DHEMATOLOGIEProf : C.SULTAN / M. GOUAULT- HELMANN / M. IMBERTService Central dHmatologie de lHopital Henri MondorFacult de mdecine de Crteil (Paris XII)

1-13

Specifications

3.5. Accuracy*

The data shows good correlation between results achieved on the ABX PENTRA 60 C+versus the reference system, which can be resumed as follows:

PARAMETER R(COMPARISON OF MEANS) ACCURACY CLAIMS

WBC 0.997 >0.95

PLT 0.998 >0.95RBC N/A N/AHGB N/A N/A

HCT N/A N/ALYM N/A N/ANEU N/A N/A

MON N/A N/AEOS N/A N/ABAS N/A N/A

3.6. Leukocyte differential count


Not available at the time of publication.

3.7. Sample stability study

Not available at the time of publication.

Pentra 60 C+

1-14

Results displayed

Use the instrument diluent to dilute the sample if a ---- D flag occurs

on WBC or Hct.

NOTE

3.8. Flags giving an analysis default

PARAMETER LINEARITY VISIBLE >VISIBLELIMITS RANGE RANGE

WBC(x103/mm3) result result+ D DILRBC(x106 /mm3) result result+ D DIL

PLT(x103/mm3) HGB>2g/dL result result+ D DILHGBVISIBLELIMITS RANGE RANGE

WBC(x103/mm3) result result+D --.-- + DRBC(x106 /mm3) result result+D --.-- + DPLT(x103/mm3) HGB>2g/dL result result+D --.-- + D

HGB

1-15

Specifications

4. REAGENTS SPECIFICATIONS

In order for the instrument to operate correctly, high-quality reagents must be used. ABXDIAGNOSTICS provides all the necessary reagents.

NOTE

The ABX Diagnostics reagents specified for this instrument may have

followed one or both of the approval methods below:

1 - have been registered by the A.F.S.S.A.P.S. Agence Franaise de

Scurit Sanitaire des Produits de Sant according to the procedure

relative to laboratory reagents used for biological analyses.

2 - or approved in accordance with the European Directive 98/79/CE

(Annex III) for in-vitro medical devices.

Please refer to the packaging of each reagent concerned to establish

the approval method.

Refer to Chapter Annex of this manual for all reagent speifications.

4.2. Waste handling precautions

If required, waste can be neutralized before being discarded. Follow your laboratorysprotocol when neutralizing and disposing of waste.

Dispose of the waste container according to the local or national regulatory requirements.

4.1. Reagent specifications

When disposing of waste, protective clothing must be worn (lab coat,

gloves, eye protection, etc). Follow your local and /or national

guidelines for biohazard waste disposal.

WARNING

Pentra 60 C+

1-16

5. LIMITATIONS

5.1. Maintenance

In Chapter 5. Maintenance & Troubleshooting, specific maintenance procedures are listed.The maintenance procedures identified are mandatory for proper use and operation of theABX PENTRA 60 C+. Failure to execute any of these recommended procedures may result inpoor reliability of the system.

Failure to execute any of these recommended procedures may result

in poor reliability of the system.

5.2. Blood specimens

Verification of any abnormal test result (including flagged results or results outside of thenormal range) should be performed using reference methods or other standard laboratoryprocedures for conclusive verification of the results. The sections below list known limita-tions of automated blood cell counters which use the principles of impedance and lightabsorbance as principles of measurement.

IMPORTANT

Whilst every effort is taken by ABX Diagnostics to investigate and

indicate all known interferences, it is by no means possible to guarantee

that all interferences have been identified. At all times, results should

be validated and communicated only once all information relating to

the patient has been assessed and taken into account.

WARNING

1-17

Specifications

RBC: Red Blood Cells (Erythrocytes)The red blood cell dilution contains all the formed elements in the blood: erythrocytes,leukocytes and platelets. During erythrocytes counting (red blood cells), platelets are notcounted as their size falls below the minimum threshold.

Agglutinated erythrocytes - May cause a low incorrect RBC count. Blood samplescontaining the agglutinated red blood cells may be suspected by elevated MCH and MCHCvalues and shown by examination of the stained blood film.

Cold agglutinins - IgM immunoglobulins which are high in cold agglutinin disease maycause lower RBC and PLT counts and increase MCV.

5.3. Known interfering substances

White Blood Cells (Leukocytes):WBC results that exceed the linearity limits of the system will require dilution of the bloodsample (Leukemia sample followed by a leukopenia).Re-assaying the diluted sample will help to obtain the correct assay value.

Unlysed Red Cells - In some rare instances, the erythrocytes in the blood sample may notbe completely lysed. These non-lysed red blood cells may be detected on the WBC histogramwith an L1 alarm or as an elevated baseline on the side (leading edge) of the lymphocytespopulation. Non-lysed erythrocytes will cause a falsely elevated WBC count.

Multiple myeloma - The precipitation of proteins in multiple myeloma patients may givehigh WBC counts.

Leukemia - A very low WBC count may result from this disease because of possible increasedfragility of the leukocytes leading to destruction of some of these cells during counting.These white cell fragments will also interfere with the white cell differential parameters.These white cell fragments will also interfere with the white cell partial differential parameters:LYM% + #, MON% + #, GRAN% + #. A suspiciously low WBC count may also be seen inpatients with lymphocytic leukemias due to the presence of abnormally small lymphocyteswhich may not be counted by the instrument.

Chemotherapy - Cytotoxic and immunosuppressive drugs may increase the fragility of theleukocytes which may cause low WBC counts.

Cryoglobulins - Increased levels of cryoglobulin that may be associated with myeloma,carcinoma, leukemia, macroglobulinemia, lymphoproliferative disorders, metastic tumors,autoimmune disorders, infections, aneurism, pregnancy, thromboembolic phenomena,diabetes, etc, which can increase the WBC, RBC or PLT counts and the HGB concentration.The specimen must be warmed up to 37C (99F) in a bain marie for 30 minutes and analyzedagain immediately after (analyzer or manual method).

Macrothrombocytes - in excessive numbers may affect and increase Leukocyte numeration.

Pentra 60 C+

1-18

MCH (Mean Corpuscular Hemoglobin)The MCH is determined according to HGB value and the RBC count. The limitations listedfor the HGB and RBC will have an effect on the MCH and may cause inaccurate values.

MCHC (Mean Corpuscular Hemoglobin Concentration)The MCHC is determined according to the HGB and HCT values. The limitations listed forthe HGB and HCT will have an effect on the MCHC and may cause inaccurate values.

Hgb (Hemoglobin):Turbidity of the blood sample - Any number of physiological and/or therapeutic factorsmay produce high incorrect HGB results. To obtain accurate hemoglobin results whenincreased turbidity of the blood sample occurs, determine the cause of the turbidity andfollow the appropriate method below:

High WBC: An extremely high WBC will cause excessive light scatter. In these cases usereference (manual) methods.The diluted sample should be centrifuged, and the supernatantfluid measured with a spectrophotometer.

High lipid concentration: A high concentration of lipids in the blood sample will give theplasma a milky appearance. This condition can occur with hyperlipidemia, hyperproteinemia(as in gammapathies) and hyperbilirubinemia. Accurate hemoglobin determinations can beachieved by using reference (manual) methods and a plasma blank.

Increased turbidity may also be seen in cases where the red blood cells are resistant tolysing. This condition will cause an incorrect high HGB result, but may be detected byobserving the abnormal MCH, MCHC values, and the increased baseline on the leadingedge of the WBC histogram. Erroneous hemoglobin results will cause the results of theMCH and MCHC to be incorrect as well.

Fetal bloods - The mixing of fetal and maternal bloods may produce a high inaccurate HGBvalue.

Hct (Hematocrit)Red blood cells agglutination - May produce an inaccurate HCT and MCV values. Redblood cell agglutination may be detected by observing abnormal MCH and MCHC values,as well as by examination of the stained blood film In such cases, manual methods may berequired to obtain an accurate HCT value.

MCV (Mean Corpuscular Volume)Red blood cell agglutination - May produce an inaccurate MCV value. Red blood cellagglutination may be detected by observing abnormal MCH and MCHC values, as well asby examination of the stained blood film. In such cases, manual methods may be required toobtain an accurate MCV value.

Excessive numbers of large platelets and/or the presence of an excessively high WBCcount may interfere with the accurate determination of the MCV value. In such cases, carefulexamination of the stained blood film may reveal the error.

1-19

Specifications

Plt (Platelets)Very small erythrocytes (microcytes), erythrocyte fragments (schizocytes) and WBC frag-ments may interfere with the proper counting of platelets and cause elevated PLT counts.

Agglutinated erythrocytes - May trap platelets, causing an erroneously low platelet count.The presence of agglutinated erythrocytes may be detected by observation of abnormalMCH and MCHC values and by careful examination of the stained blood film.

Giant platelets in excessive numbers - may cause a low inaccurate platelet count asthese large platelets may exceed the upper threshold for the platelet parameter and are notcounted.

Chemotherapy - Cytotoxic and immunosuppressive drugs may increase the fragility ofthese cells which may cause low PLT counts. Reference (manual) methods may be necessaryto obtain an accurate platelet count.

Hemolysis - Hemolysed specimens contain red cell stroma which may increase plateletcounts.

A.C.D. blood - Blood anticoagulated with acid-citrate-dextrose may contain clumped plateletwhich could decrease the platelet count.

Elevated triglycerides and/or cholesterol: may interfere with correct platelet counting.

Platelet agglutination - Clumped platelets may cause a decreased platelet count and/or ahigh WBC count. The specimen should be recollected in sodium citrate anticoagulant toensure the anticoagulated character depending on agglutination and reanalyzed only for theplatelet count. The final PLT result must be corrected for the sodium citrate dilution effect.However, these platelet clumps do trigger flags L1, LL and LL1.

RDW (Red blood cell Distribution Width)The red blood cell distribution width is determined according to the RBC count.

Nutritional deficiency or blood transfusion - May cause high RDW results due to ironand/or cobalamin and /or folate deficiency.

MPV (Mean Platelet Volume)Giant platelets that exceed the upper threshold of the Platelet parameter may not be countedas platelets. Consequently, these larger platelets will not be included in the instrumentscalculation of Mean Platelet Volume.

Very small erythrocytes (microcytes), erythrocytic fragments (Schizocytes) and white bloodcell fragments may interfere with the proper counting and sizing of Platelets.

Agglutinated erythrocytes - May trap Platelets, causing an incorrect MPV result. Thepresence of agglutinated erythrocytes may be detected by observation of abnormal MCHand MCHC values and by careful examination of the stained blood film.

Chemotherapy - May also affect the sizing of PLTs.

Blood samples collected in EDTA will not maintain a stable Mean

Platelet Volume. Platelets collected in EDTA swell depending on the

time post-collection and storage temperature.

IMPORTANT

Pentra 60 C+

1-20

LYM# (Lymphocyte count absolute value), LYM% (Lymphocyte percentage)The Lymphocyte count is derived from the WBC count. The presence of erythroblasts, cer-tain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYMcount. Limitations listed for the WBC count pertain to the LYM # and % counts as well.

MON# (mononuclear cell count absolute), MON% (Mononuclear percentage)The mononuclear cell count absolute is derived from the WBC count. The presence of largelymphocytes, atypical lymphocytes, blasts and an excessive number of basophils mayinterfere with an accurate monocyte count. Limitations listed for the WBC count pertain tothe MON # and % counts as well.

NEU# (neutrophil count absolute), NEU% (Neutrophil percentage)The neutrophils cell count is derived from the WBC cell count. The excessive presence ofeosinophils, metamyelocytes, myelocytes, promyelocytes, blasts and plasma cells mayinterfere with an accurate neutrophils count.

EOS# (Eosinophil cell count absolute), EOS% (Eosinophil percentage)The eosinophil cell count is derived from the WBC cell count. The presence of abnormalgranules (degranulated areas, toxic granules...) may interfere with the eosinophil counting.

BAS# (Basophil cell count absolute), BAS% (Basophil percentage)The Basophil cell count is derived from the WBC cell count.

(Pentra 60 C+HYDRAULIC&PNEUMATIC PRINCIPLES

1. HYDROPNEUMATIC CONNECTIONS ..................................... 2-2

2. FUNCTION OF VALVES .......................................................... 2-5

3. VALVES LOCATIONS .............................................................. 2-6

4. PNEUMATIC DIAGRAM .......................................................... 2-7

(Pentra 60 C+

2-2

1. HYDROPNEUMATIC CONNECTIONS

FROM LENGTH DIAM. TOABX CLEANERAbx Cleaner Bottle 2.05 400 LV7_1

LV7_3 2.05 120 Diluter Syringe_2

LV7_2 1.52 230 LV12_3

LV12_1 1.52 350 Baso/WBC chamber_1

LV12_2 1.52 280 T3_3ABX EOSINOFIXAbx Eosinofix Bottle 2.05 400 LV8_1


LV8_2 1.52 500 Reagent Heater_3SReagent Heater_4S 1.52 120 LMNE chamber_3ABX BASOLYSE IIAbx Basolyse II Bottle 2.05 400 LV11_1


LV11_2 1.52 500 Reagent Heater_10SReagent Heater_9S 1.52 60 Reagent Heater_11SReagent Heater_12S 1.52 120 BASO/WBC chamber_2ABX ALPHALYSEAbx Alphalyse Bottle 1.52 350 LV6_1


LV6_2 1.52 480 DIL1/HGB chamber_2SAMPLINGProbe_1 1.02 205 Sampling Syringe_1LMNE COUNTINGLMNE chamber_4 1.30 20 M1_2 photocell

M1_1 photocell 1.30 320 LV4_1

LV4_2 1.02 130 T2_2

T2_3 1.02 240 Injector Syringe_5

Injector Syringe_3 1.02 95 LV5_1

LV5_2 2.05 420 T6_2

T2_1S 1.85 11 LMNE flowcell_60.19 4 LMNE flowcell_6

LMNE flowcell_Output 1.52 20 E1_1 Anode fitting

E1_2 Anode fitting 1.52 70 Isolator_1

Isolator_2 1.52 80 E2_1 Ground fitting

E2_2 Ground fitting 1.52 335 LV24_2

LV24_1 1.52 120 T4_2

T4_1 1.52 160 Reagent Heater_5SReagent Heater_6S 1.52 120 LMNE chamber_2

Read this table as follow: LV3_2S means connection to port 2 of valve 3 with a Sleeving.

2-3

Hydraulic &Pneumatic Principles

FROM LENGTH DIAM. TODILUENTDiluent Input 2.54 170 LV25_2SLV25_1S 2.54 140 Diluent Tanker_4S

2.05 65 Diluent Tanker_1

Diluent Tanker_1 2.05 350 LV3_1

LV3_3S 2.05 120 Injector Syringe_2LV3_2S 1.52 50 LV2_3SLV2_1S 1.52 50 LV1_3SLV1_1S 1.52 200 Isolator_1SIsolator_2S 1.52 100 T1_1T1_2 1.14 35 LMNE flowcell_4

T1_2 XBA403 LMNE flowcell_4

T1_3 1.14 35 LMNE flowcell_2

T1_3 XBA403 LMNE flowcell_2

LV1_2 1.52 250 T4_3

LV2_2 1.02 175 Injector Syringe_4

Injector Syringe_1 1.02 205 LMNE flowcell_5

LMNE flowcell_7 1.02 10 (Cap)

2.05 65 Diluent Tanker_3

Diluent Tanker_3 2.05 480 LV9_1


LV9_2 1.52 50 LV10_3

LV10_1 1.52 15 T3_2

T3_1 1.52 640 LV18_3

LV18_1 1.52 50 LV19_3

LV19_1 1.52 190 T12_1

T12_3 1.52 75 Probe Rinsing Body_1

T12_2 1.30 15 Isolator_1

Isolator_3 1.52 215 LV32_1

LV32_2 1.52 780 T5_2

LV19_2 1.52 300 Probe Rinsing Body_2

LV18_2 1.02 115 Sampling Syringe_2

LV10_2 1.52 380 LV21_3

LV21_1 1.52 50 LV22_3

LV22_1 1.52 200 Reagent Heater_7SReagent Heater_8S 1.52 120 RBC chamber_1LV22_2 1.52 260 Reagent Heater_1SReagent Heater_2S 1.52 120 DIL1/HGB chamber_1LV21_2 1.52 220 Baso/WBC chamber_4

(Pentra 60 C+

2-4

FROM LENGTH DIAM. TOWBC/RBC COUNTINGBASO/WBC chamber_3 1.52 200 LV23_3

LV23_1 1.52 220 RBC chamber_3

RBC chamber_2 1.52 430 LV14_2

LV14_1 1.52 70 Counting Syringe_2

LV23_2 1.52 310 Counting Syringe_3DRAININGSRinse chamber_3 2.05 30 Filter_1

Filter_2 2.05 30 LV27_2

LV27_1 2.05 30 T7_3

DIL1/HGB chamber_3 2.05 70 LV28_2

LV28_1 2.05 20 T7_2

T7_1 2.05 20 T8_3

LMNE chamber_5 2.05 70 LV29_2

LV29_1 2.05 20 T8_2

T8_1 2.05 20 T9_3

RBC chamber_4 2.05 60 LV30_2

LV30_1 2.05 20 T9_2

T9_1 2.05 20 T10_2

BASO/WBC chamber_5 2.05 55 LV31_2

LV31_1 2.05 20 T10_1

T10_3 2.05 30 T6_3

T6_1 2.05 20 T5_3

T5_1 2.05 50 M2_1 photocell

M2_2 photocell 2.05 15 Isolator_1

Isolator_2 2.05 280 LV26_1

LV26_3S 2.54 150 Draining Syringe_2SLV26_2S 2.54 130 T11_3Counting Syringe_5 2.05 125 LV16_1

LV16_2S 2.54 340 T11_2T11_1 2.54 20 Waste OutputAIRAtmosphere 2.05 140 LV13_2


Atmosphere 2.05 100 LV15_1

LV15_3 1.52 400 Diluent Tanker_2


Atmosphere 2.05 70 LV17_2

LV17_1 1.30 185 Isolator_2

Rinse_2 chamber (Atmo.) 2.05 300 LV20_2

LV20_1 1.52 90 Draining Syringe_1

2-5


VALVE # VALVE SUBJECT VALVE FUNCTIONS1 DIL LMNE Directing optical chamber / LMNE chamber

2 DIL LMNE Directing Internal / External sleeving

3 DIL LMNE Control Entry / Exit syringe

4 LMNE Transfer control LMNE tray /Injection syringe

5 LMNE Transfer control LMNE tray /Injection syringe

6 LYSE Control Entry / Exit syringe

7 CLEANER Control Entry / Exit syringe

8 EOSINOFIX Control Entry / Exit syringe

9 DIL Control Entry / Exit syringe

10 DIL Directing Circuit chamber / Needle circuit

11 BASOLYSE II Control Entry / Exit syringe

12 CLEANER Directing WBC/BASO chamber / Needle circuit

13 COUNTING SYRINGE Set in the atmosphere

14 COUNTING SYRINGE RBC/PLT count

15 TANK Set in the atmosphere

16 COUNTING SYRINGE Draining

17 NEEDLE Flushing out of rinsing unit

18 NEEDLE Commutation Diluent interior/exterior Needle

19 NEEDLE Probe cleaning

20 DRAINING SYRINGE Set in the atmosphere

21 DIL Directing head for WBC count / Valve 22

22 DIL Directing diluent chamber dil.1

23 COUNTING SYRINGE WBC/RBC selection count

24 LMNE Exit from the optical chamber

25 DILUENT TANK Entry of the diluent

26 FLUSHING SYRINGE Flushing of the syringe

27 CHAMBER GROUP Drain rinse chamber

28 CHAMBER GROUP Drain first dilution chamber

29 CHAMBER GROUP Drain LMNE chamber

30 CHAMBER GROUP Drain RBC/PLT chamber

31 CHAMBER GROUP Drain WBC/BASO chamber

32 NEEDLE Probe cleaning

2. FUNCTION OF VALVES

(Pentra 60 C+

2-6

Valve blocks are located close to the elements concerned. There are 5 different blocks:

3. VALVES LOCATIONS

Valves 1 to 11:On the left side,Horizontal block,On the top of the reagent and injection syringes.

Valves 12 to 16:On the left side,Vertical block,Beside the counting syringe.

Valves 20 to 26:On the right side,Vertical block,Beside the draining syringe.

Valves 27 to 31:On the right side,Horizontal block,On top of the blending and count chambers.

Valves 17 to 19 & 32:On the right side,Horizontal block,On ampling carriage.

2-7


4. PNEUMATIC DIAGRAM See Pneumatic diagram on next page.

(Pentra 60 C+ELECTRIC&ELECTRONIC PRINCIPLES

1. MAIN BOARD TEST POINTS ................................................... 3-2

2. MAIN BOARD POTENTIOMETERS ......................................... 3-4

3. PENTRA 60 C+ BOARDS........................................................ 3-53.1 Main board XAA 425 C .................................................... 3-53.2. Optical Preampli board XAA 423 B ................................. 3-63.3. Motor relay board XAA 427 B......................................... 3-73.4. Carriage board XAA 428 C ............................................. 3-83.5. LED board XAA 429 A .................................................... 3-9

4. PENTRA 60 C+ CONNECTORS ............................................. 3-104.1. Chamber Heating Connector XBA 386 A ....................... 3-104.2. Reagent Heating Coil Connector XBA 387 A .................. 3-114.3. Horizontal Carriage Motor XBA 391 A ........................... 3-124.4. Upper Fan XBA 393 A ................................................... 3-134.5. IR sensor XBA 394 AS ................................................... 3-144.6. IR sensor XBA 395 AS ................................................... 3-154.7. IR sensor XBA 396 AS ................................................... 3-164.8. IR sensor XBA 397 AS ................................................... 3-174.9. RBC / WBC coaxe XBA 398 B ...................................... 3-184.10. LMNE flowcell coaxe XBA 399 AS ............................... 3-194.11. Barcode reader cable XBA 402 AS .............................. 3-204.12. Diluent level sensor XDA 605 AS .................................. 3-21

5. PENTRA 60 C+ SYNOPTIC ................................................... 3-22

(Pentra 60 C+

3-2

1. MAIN BOARD TEST POINTSTEST POINT POTEN- TARGET TOLERANCE REMARKDESIGNATION TIOMETERTP1 HB Blank adjustment R248 4.7V +/- 0.05V

TP2 PLT Threshold adjustment R159 300mV +/- 5mV

TP3 LMNE CIS Threshold adjustment R160 650mV +/- 5mV

TP4 LMNE OD Threshold adjustment R161 350mV +/- 5mV

TP5 Draining syringe motor R149 4.8V +/- 0.05V

TP6 Counting syringe motor R150 4.8V +/- 0.05V

TP7 Dilutor syringe motor R151 4V +/- 0.05V

TP8 Injection syringe motor R152 3V +/- 0.05V

TP9 UNUSED

TP10 Horizontal carriage motor R154 3V +/- 0.05V

TP11 Sample syringe motor R155 2V +/- 0.05V

TP12 Probe carriage motor R156 4.5V +/- 0.05V

TP13 RBC Threshold adjustment R158 300mV +/- 5mV

TP14 BASO Threshold adjustment R157 300mV +/- 5mV

TP15 BASO Comparator

TP16 RBC Comparator

TP17 PLT Comparator

TP18 LMNE CIS Comparator

TP19 LMNE OD Comparator

TP20 RBC line height adjsutment R133 XX V +/- 50mV Factory Adjusted

TP21 BASO gain adjustment R134 XX V +/- 50mV Factory Adjusted

TP22 PLT line height adjustment R135 XX V +/- 50mV Factory Adjusted

TP23 LMNE Resistive gain adjustment R136 XX V +/- 50mV Factory Adjusted

TP24 LMNE Optical gain adjustment R148 XX V +/- 50mV Factory Adjusted

TP25 RBC line width adjustment

TP26 RBC line reject adjustment R142 10s +/- 0.5s Factory Adjusted

TP27 RBC line pulse adjustment

TP28 BASO line width adjustment

TP29 BASO line reject adjustment R139 10s +/- 0.5s Factory Adjusted

TP30 BASO line pulse adjustment

TP31 PLT line width adjustment

TP32 PLT line reject adjustment R144 10s +/- 0.5s Factory Adjusted

TP33 PLT line pulse adjustment

TP34 LMNE Resistive line width adjustment

TP35 LMNE Resistive line reject adjustment R145 15s +/- 0.5s Factory Adjusted

TP36 LMNE Resistive line pulse adjustment

TP37 LMNE Optical line width adjustment

TP38 LMNE Optical line reject adjustment R147 5s +/- 0.5s Factory Adjusted

TP39 LMNE Optical line pulse adjustment

3-3

Electric &Electronic Principles

TEST POINT POTEN- TARGET TOLERANCE REMARKDESIGNATION TIOMETERTP40 5V Power supply 5V

TP41 12V Power supply 12V

TP42 24V Power supply 24V

TP43 -12V Power supply -12V

TP44 GROUND

TP45 GROUND

TP46 GROUND

TP47 GROUND

TP48 LMNE Draining sensor R286

(Pentra 60 C+

3-4

POTENTIOMETERDESIGNATION TEST POINT TARGET TOLERANCE REMARKR133 RBC line height adjsutment TP20 F.A.

R134 BASO gain adjustment TP21 F.A.

R135 PLT line height adjustment TP22 F.A.

R136 LMNE Resistive gain adjustment TP23 F.A.

R139 BASO line reject adjustment TP29 F.A.

R142 RBC line reject adjustment TP26 F.A.

R144 PLT line reject adjustment TP32 F.A.

R145 LMNE Resistive line reject adjustment TP35 F.A.

R147 LMNE Optical line reject adjustment TP38 F.A.

R148 LMNE Optical gain adjustment TP24 F.A.

R149 Draining syringe motor TP5 4.8V +/- 0.05V

R150 Counting syringe motor TP6 4.8V +/- 0.05V

R151 Dilutor syringe motor TP7 4V +/- 0.05V

R152 Injection syringe motor TP8 3V +/- 0.05V

R154 Horizontal carriage motor TP10 3V +/- 0.05V

R155 Sample syringe motor TP11 2V +/- 0.05V

R156 Needle carriage motor TP12 4.5V +/- 0.05V

R157 BASO Threshold adjustment TP14 300mV +/- 5mV

R158 RBC Threshold adjustment TP13 300mV +/- 5mV

R159 PLT Threshold adjustment TP2 300mV +/- 5mV

R160 LMNE CIS Threshold adjustment TP3 650mV +/- 5mV

R161 LMNE OD Threshold adjustment TP4 350mV +/- 5mV

R248 HB Gain adjustment TP1 4.7mV +/- 0.1mV

2. MAIN BOARD POTENTIOMETERS

3-5


3. PENTRA 60 C+ BOARDS

3.1 Main board XAA 425 C

(Pentra 60 C+

3-6

OPTICAL PRE-AMPLI BOARD:

Perform an absorbance measurement This is an Intensity / Tension convertissor A photodiode measures absorbance of light through the cell, the optical pre-ampli boardreturns an intensity proportionnal to the light signal (Light signal is proportionnal to the cellsize)

3.2. Optical Preampli board XAA 423 B

3-7


3.3. Motor relay board XAA 427 B

MOTOR RELAY BOARD:

Interconnection board where all the different motors and end of run sensor are connected This board is connected to the main board with a flat cable

(Pentra 60 C+

3-8

3.4. Carriage board XAA 428 C

CARRIAGE BOARD:

Interconnection board where all the carriage electrical functions are connected This board is connected to the main board with a flat cable

3-9


3.5. LED board XAA 429 A

LED BOARD:

This board supports LEDs on the front panel. They give instrument state:Red: instrument is busyGreen: instrument is ready to sample

(Pentra 60 C+

3-10

4. PENTRA 60 C+ CONNECTORS

4.1. Chamber Heating Connector XBA 386 A

3-11


4.2. Reagent Heating Coil Connector XBA 387 A

(Pentra 60 C+

3-12

4.3. Horizontal Carriage Motor XBA 391 A

3-13


4.4. Upper Fan XBA 393 A

(Pentra 60 C+

3-14

4.5. IR sensor XBA 394 AS

3-15



(Pentra 60 C+

3-16


3-17



(Pentra 60 C+

3-18

4.9. RBC / WBC coaxe XBA 398 B

3-19


4.10. LMNE flowcell coaxe XBA 399 AS

(Pentra 60 C+

3-20

4.11. Barcode reader cable XBA 402 AS

3-21


4.12. Diluent level sensor XDA 605 AS

(Pentra 60 C+

3-22

5. PENTRA 60 C+ SYNOPTIC

(Pentra 60 C+ANALYSIS CYCLE TECHNOLOGY

1. ANALYSIS CYCLE DESCRIPTION ............................................ 2-2

2. MEASURING PRINCIPLES ...................................................... 2-42.1. Multi Distribution Sampling System (MDSS) .................... 2-42.2. RBC / Plt detection principles ......................................... 2-52.3. Hgb measurement ......................................................... 2-62.4. Hct measurement .......................................................... 2-72.5. RDW calculation ............................................................. 2-72.6. MCV, MCH, MCHC calculation ....................................... 2-72.7. MPV Measurement ........................................................ 2-82.8. Pct calculation ................................................................ 2-82.9. PDW calculation ............................................................. 2-82.10. WBC and differential count ........................................... 2-9

2.10.1. General principles .................................................. 2-92.10.2. BASO / WBC Count .............................................. 2-92.10.3. LMNE matrix ........................................................ 2-10

(Pentra 60 C+

4-2

1. ANALYSIS CYCLE DESCRIPTION Aspiration of blood sample from the tube trough the cap (53l) Translation of sampling carriage over Rinse chamber.

Cleaning of the needles: Internal cleaning: 1ml inside piercing needle External cleaning: 2ml outside piercing needle Internal cleaning: 1ml inside piercing needle and reject of 3l of blood(not used).

Translation of sampling carriage DIL1 chamber (first dilution), descent ofthe needle. Positioning the needle point into a tangential flux of ABX diluent (1.65ml)and synchronised distribution of 10l of blood.

Translation of sampling carriage over WBC/BASO count chamber. Positioning the needle point into a tangential flux of 2ml of ABX BASOLYSEII and synchronised distribution of 10l of blood.

Translation of sampling carriage over LMNE mixing chamber. Positioning the needle point into a tangential flux of 1ml of ABX Eosinofixand synchronised distribution of 25l of blood.

!

4-3

Analysis CycleTechnology

Translation of sampling carriage over Rinse chamberRinsing of the needles: Internal rinsing: 0.8ml inside sampling needle External rinsing: 0.5ml outside sampling needle Internal rinsing: 0.5ml inside sampling needle External rinsing: 0.3ml outside sampling needle

Translation of sampling carriage over DIL1 chamber Sample of the 42.5l of the first dilution.

WBC and LMNE counting: 1ml of diluent into LMNE chamber Dilution transfer trough LMNE flowcell and counting during 12 seconds WBC\BASO counting

Translation of sampling carriage over Rinse chamber. Rinsing of the exterior of sampling needle with 0.4ml of diluent

Translation of sampling carriage over RBC and PLT count chamber. Distribution of the 42.5l of first dilution into a flux of 2.20ml of diluent. Distribution of 0.3ml of diluent from the interior of the needle.

"#$%&'()

Hgb: Distribution of 0.36ml of ABX ALPHALYSE into DIL1 chamber while bubbling.WBC\BASO chamber rinsing: Draining and filling with 1ml of ABX CLEANER and 1.5ml of diluentRBC\Plt counting and Hgb measurementChambers cleaning and Hgb blank Draining and filling of DIL1 chamber with 2.7ml of diluent Measurement of Hgb blank Flowcell rinsing (about 1.6ml of diluent) Draining and filling of RBC chamber with 2.5ml of diluent

(Pentra 60 C+

4-4

2. MEASURING PRINCIPLES

2.1. Multi Distribution Sampling System (MDSS)+

ABX PENTRA 60 C+ analysiscycle needs

3 blood specimens distributedas follows:

one specimen for the firstRBC/Plt dilution and the Hgb

measurement.

another specimen for theBASO/WBC count.

the last specimen for theLMNE matrix.

+ Specimen distribution in

the chambers is carried out in atangential flow of reagent

which allows perfect mixing ofthe dilution and avoids any

viscosity problems (this multidistribution in a reagent flow is

an ABX DIAGNOSTICS patent).

These 3 specimens areprovided by means

of a multidistributionprinciple:

53 l of blood are aspiratedinside the needle (sufficient

volume for all dilutions) thendivided up and distributed tothe chambers with reagents.

Extremities of the specimenare not delivered to the dilu-

tions.

Diluent

Air bubble

Not used

LMNE Dilution

WBC\BASO Dilution

RBC\PLT\HGB first dilution

Not used

Needle

Reagentinput

Tangential Flow Mix

Mixing chamber

BLOOD DISTRIBUTION IN A TANGENTIAL FLOW

SPECIMENS INSIDE THE NEEDLE

4-5


2.2. RBC / Plt detection principles+

Measurement ofimpedance variation

generated by the passage ofcells through a calibrated

micro aperture.

The specimen is diluted in anelectrolytic diluent (current

conductor) and pulled throughthe calibrated micro-aperture.Two electrodes are placed on

either side of the aperture.Electric current passes through

the electrodes continuously.

When the cell passes throughthe aperture, electric resistance

between the two electrodesincreases proportionately with

the cell volume.

The generated impulses havea very low voltage, which the

amplification circuit increases,so that the electronic system

can analyze them and eliminatethe background noise.

TECHNICAL CHARACTERISTICS OF THE RED BLOOD CELL AND PLATELETCOUNTS

Initial blood volume 10 l Method Impedance

Vol. ABX DILUENT 2500 l Aperture diameter 50 m

Final dilution rate** 1/10000 Count vacuum 200 mb

Temperature of reaction 35C Count period 2 X 5 seconds**: TWO SUCCESSIVE DILUTIONS ARE CARRIED OUT :PRIMARY DILUTION FOR RBC AND PLT:Blood (l): 10

ABX DILUENT (L): 1700 dilution: 1/170

SECONDARY DILUTION RBC AND PLT (FROM THE PRIMARY DILUTION):

Dilution (l): 42.5

ABX DILUENT(L): 2500 dilution: 1/58.8FINAL DILUTION: 1/170 X 1/58.8 =1/10000

Solution to be ananlyzed

Volts

TimePulse

Electrodes

Vacuum = Constant

Analyzingelectronic

circuit

(Pentra 60 C+

4-6

Results Number of cells counted per volume unit x Calibration coefficient.

HistogramsRBC: Distribution curves on 256 counting channels from 30fl to 300fl.

Plt: Distribution curves on 256 channels from 2fl to a mobile threshold. This thresholdmoves according to the microcyte population present in the analysis area.

The hemoglobin released by the lysis of the red blood cells combines with thepotassium cyanide to form the chromogenous cyanmethemoglobin compound.This compound is then measured through the optical part of the first dilutionchamber using a spectrophotometric technique at a wavelength of 550 nm.

2.3. Hgb measurement

TECHNICAL CHARACTERISTICS FOR THE MEASUREMENT OF THE HEMOGLOBIN:Volume of blood 10 l Method Photometry

Volume ABX DILUENT 1700 l Wavelength 550 nm

Volume ABX ALPHALYSE 400 l

Complement ABX DILUENT 400 l

Final dilution rate 1/250

Temperature of reaction 35C

Result Final Hgb result represents: Absorbance value obtained x coefficient of calibration.

RBC

4-7


The height of the impulse generated by the passage of a cell through the micro-aperture is directly proportional to the volume of the analyzed RBC.

The hematocrit is measured as a function of the numeric integration of the MCV.

2.4. Hct measurement

2.5. RDW calculation

The study of the RBC distribution detects erythrocyte anomalies linked toanisocytosis.A Red Cell Distribution Width (RDW) will enable you to follow the evolution of thewidth of the curve in relation to the cell number and average volume.

K SDRDW=

MCV

With: K = system constant SD = Determined standard deviation according to statistical studies on cell dis-tribution. MCV = Mean Corpuscular Volume of erythrocytes

MCV (Mean Cell Volume) is calculated directly from the RBC histogram.

MCH (Mean Cell Hemoglobin) is calculated from the Hgb value and the RBCnumber.The mean hemoglobin weight in each RBC is given by the formula:

HgbMCH (pg) = x 10

RBC

MCHC (Mean Corpuscular Hemoglobin Contained) is calculated according tothe Hgb and Hct values. Mean Hgb concentration in the total volume of RBC isgiven by the formula:

HgbMCHC (g/dL) = x 100

Hct

2.6. MCV, MCH, MCHC calculation

(Pentra 60 C+

4-8

The MPV (Mean Platelet Volume) is directly derived from the analysis of theplatelet distribution curve.

2.7. MPV Measurement

Thrombocrit is calculated according to the formula:

Plt (103/l) x MPV (m3)Pct% =

10 000

2.8. Pct calculation

2.9. PDW calculation

PDW (Platelet Distribution Width) iscalculated from the Plt histogram.

The PDW is represented by the width of the curve between

15% of the number of platelets starting from 2 fl (S1),

and 15% of the number of plateletsbeginning with the variable

top threshold (S2).

S1 S2

PDW

4-9


2.10. WBC and differential count

2.10.1. General principles

The WBC count is carried out twice by two different sensors: In the BASO count chamber at the same time as the BASOS count, In the optical chamber during the acquisition of the LMNE matrix.

The reference count is the one obtained in the WBC and BASO count chamber.

2.10.2. BASO / WBC Count

Detection principle is the same as for RBC.Differentiation betwen BASOs and other leukocytes is obtained by means of theBASOLYSE II specific lysing action.

All the WBCs are counted between the electrical threshold threshold .The basophils are located from threshold to threshold .

TECHNICAL CHARACTERISTICS OF THE WBC/BASO COUNTBlood volume 10 l Method Impedance

BASOLYSE II volume 2000 l Ruby diameter 80 m

Dilution rate 1/200 Depression of count 200 mb

Reaction temperature 35 C Duration of the count 2 X 6 seconds

ResultsWBC: Number of cells per volume x coefficient of calibration.

BASO: Number of cells per volume x coefficient of calibration in percentageregarding the total number of leukocytes (BASO + WBC nuclei)

BA1 BA2 BA3

WBC BASO

(Pentra 60 C+

4-10

2.10.3. LMNE matrix

The WBC and Differential countare based on 3 essential

principles:

1- The doublehydrodynamic sleeving

DHSS (ABX DIAGNOSTICSpatent)

2- The volumemeasurement

impedance changes.

3- The measurement oftransmitted light

with 0 angle, which permits aresponse according to the

internal structure of eachelement and its absorbance by

means of incident light diffu-sion.

25l of whole blood isdelivered to the LMNE

chamber in a flow ofEOSINOFIX. This reagent lysesthe RBC, stabilizes the WBC in

their native forms and stainsthe eosinophil nuclei with a

specific coloration. The solution is then stabilizedwith diluent and transferred tothe measuring chamber. Each

cell is measured both inabsorbance (cytochemistry)

and resistivity (volume).

TECHNICAL CHARACTERISTICS OF THE WBC COUNT DURING THE ACQUISITION OFTHE MATRIXBlood volume 25 l Method Impedance

with hydrofocus

Eosinofix volume 1000 l Ruby diameter 60 m

Diluent volume 1000 l Flow diameter 42 m

Final dilution rate 1/80 Injection duration 12 seconds

Reaction temperature 35 C Volume injected 72 l

Incubation duration 12 s.

Results From these measurements, a matrix is drawn up with volumes on the X-axis andoptical transmission on the Y-axis.The study of the matrix image permits the clear differentiation of 4 out of 5 leukocytepopulations. As a matter of fact, the basophil population is very small comparedto the other 5 in a small blood sample.

1) PRIMARY FOCUSED FLOW FOR IMPEDANCEMEASUREMENT

2) SECOND FOCUSED FLOW FOR OPTICALDETECTION

4-11


NEUTROPHILS EOSINOPHILS

LIC

MONOCYTESALYLYMPHOCYTES

LMNE

ABSO

RBAN

CE

VOLUME

(Pentra 60 C+

4-12

LYMPHOCYTES: The lymphocytes being small with regular shape, are positioned in the lower part ofboth the optical axis and volume axis. Normal lymphocyte populations are generally observed with agood volume homogeneity. Large lymphocytes are detected in the ALY (Atypical Lymphocytes) zone,where reactive lymphoid forms, stimulated lymphocytes and plasmocytes are also to be found. The farleft side of the lymphocyte zone should normally be empty, but when small lymphocytes are present,population may exist in this area. The presence of platelet aggregates is detected by a distribution patternthat moves from the origin of the matrix (background zone) into the lymphocyte zone. The NRBCs withtheir cytoplasmic membranes lysed like the erythrocytes, will have their nuclei situated to the far left sideof the lymphocyte zone.

MONOCYTES: The monocytes, being cells with large kidney shaped nuclei and a large non-granularcytoplasm, will neither be scattered nor absorb a large amount of light. They will therefore be positionedin the lower part of the optical axis but clearly to the right of the volume axis. Certain large monocytes canbe found on the right side of the matrix in the lower LIC (Large Immature Cells) zone. The immaturegranulocytic cells are detected by their larger volumes and by the presence of granules which increasethe intensity of the scattered light. Therefore, cells such as metamyelocytes will be found clearly to theright of the neutrophils and nearly at the same level. Myelocytes and promyelocytes will be found insaturation position on the far right of the matrix. These last three populations will be counted as LIC (LargeImmature Cells) and their given results are included in the neutrophil value. The blast cells will be foundgenerally to the right of the monocytes, and, as such, will increase the LIC count. Small blasts will befound between the normal lymphocytes and monocytes. Platelets and debris from erythrocyte lysisrepresent the background noise population located in the lower left area of the matrix. Most of the popu-lation partition thresholds are fixed and give the limits of the morphological normality of leukocytes. Chan-ges in the morphology of a population will be expressed on the matrix by a shifting of the correspondingpopulation.

EOSINOPHILS: With reagent action on cytoplasmic membranes, the leukocytes keep their native sizeand only eosinophils are colored for optical separation. Eosinophils will be situated in the upper part of theoptical Y-axis due to their strong absorbance qualities and their size, which is nearly equivalent to largeneutrophils.

NEUTROPHILS: The neutrophils, with their cytoplasmic granules and their generally segmented nuclei,will scatter light depending on their morphological complexity. A hypersegmented neutrophil will give anincreased optical response with respect to a young neutrophil population which will be in the upperposition of the optical axis depending on the presence of segmentation and/or granules.

(Pentra 60 C+SOFTWARE VERSIONS

1. SERVICE SOFTWARE OVERVIEW ........................................... 5-2

2. SOFTWARE RELEASES .......................................................... 5-32.1. Software releases table .................................................. 5-32.2. Software modifications ................................................... 5-3

(Pentra 60 C+

5-2

1. SERVICE SOFTWARE OVERVIEW

+ Initialization+ Check motors+ Check valves+ Sampling needle adjustment+ Maintenance carriage position+ Park syringe position

MECHANICAL SYSTEMS

+ Drain chamber+ Rinse+ Cleaning cycle+ Prime cycles

HYDRAULIC SYSTEMS

+ Sampling needle adjustment+ Draining sensor adjustment+ Transfer sensor adjustment+ Vacuum adjustment+ Cycles+ Heating coil adjustment+ Thermostatic compartment adjustment+ Bublbing+ Carriage dilution positions

TECHNICIAN ADJUSTMENT

+ Gain adjustment+ LMNE calibration+ Pulse adjustment

TECHNICIAN MEASUREMENT

+ Burn in parameters

BURN IN CYCLE

+ Connection test & command+ Service mode+ Configure Analyzer Main board

RS232 TO P60

5-3

Software Versions

2. SOFTWARE RELEASES

2.1. Software releases table

2.2. Software modifications

Between software released, the software or techchnical evolutions may be described inTechnical notes.

TECHNICAL NOTE SOFTWARE REVISION DATERAH801A V1.61 14/04/2001RAN015A V2.2.9 15/02/2004

(Pentra 60 C+OUTPUT FORMAT

Refer to document ABX Diagnostics OUTPUT FORMAT RAA024

(Pentra 60 C+ALARMS & ERROR LIST

1. TRANSMISSION ...................................................................... 7-2

2. DATABASE ............................................................................. 7-2

3. WORKLIST ............................................................................. 7-2

4. CALIBRATION ........................................................................ 7-3

5. TECHNICAL OPERATIONS ..................................................... 7-3

6. PRINTER ................................................................................ 7-3

(Pentra 60 C+

7-2

1. TRANSMISSIONDISPLAYED MESSAGE CAUSES ACTIONNo ENQ Character Received On RS232

No ACK Character Received On RS232

Write Error On RS232 Defect on transmission Check RS232 setup

Internal Error On RS232 operations Menu\Service\RS232 TO P60

Time Out Reached

Too Many Characters Received On RS232

Connection To Analyser Failed Time out Disconnect/Reset/Connect

from menu RS232 TO P60

Communication to S.I.L. : Spooler full, result lost !

Result transmission capacity exceeded, only the first XX will be sent

Connection Failure - - - - - -

2. DATABASEDISPLAYED MESSAGESimilar Reference Found In The Database

Result Not Recorded, File Full

Result Not Recorded, Write Error In Database

Insufficient free disk space !

There Is No Valid Backup

Abnormal Backup Termination !

Abnormal Restore Termination !

File XX Not Found In YY Directory

3. WORKLISTDISPLAYED MESSAGESample Id Already Exists In Worklist !

Rejected Result Not Recorded

Invalid Date

Invalid Gender Entry

Patient Name Field Cannot Be Empty !

Sample Id Field Cannot Be Empty !

Patient Information Cannot Be Modified, Result Already Exist !

7-3

Alarms &Error list

6. PRINTER

4. CALIBRATION

5. TECHNICAL OPERATIONS

DISPLAYED MESSAGEMinimum Of 3 Results Required For Calibration

Calibration Failed : Confirm To Force Calibration

Calibration Failed : Coef. Out Of Range

Minimum Of 5 Results Required To Calibrate

DISPLAYED MESSAGEValues Out Of Range : [XX]

YY Value Out Of Range [XX - ZZ]

YY Value Cannot Be Less Than XX Value

YY Value Cannot Be Less Than 1

YY Value Must Be Positive

Access denied

Invalid Value(s) On XX Pathological Limits

Thresholds not saved. - - - - Acceptance conditions violated:

DISPLAYED MESSAGEAre windows messages

(Pentra 60 C+MAINTENANCE

1. MAINTENANCE ...................................................................... 8-21.1. Introduction ..................................................................... 8-21.2. Daily customer maintenance .......................................... 8-21.3. Weekly customer maintenance ...................................... 8-21.4. Maintenance table .......................................................... 8-3

2. MAINTENANCE KITS ............................................................. 8-42.1. 6 month maintenance kit ................................................ 8-42.2. Yearly maintenance kit ................................................... 8-42.3. Pistons maintenance kit ................................................. 8-52.4. Fitting kit ......................................................................... 8-52.5. Screws kit ...................................................................... 8-6

3. PROCEDURES ....................................................................... 8-73.1. Required tools and product ............................................ 8-73.2. Procedure chart table .................................................... 8-83.3. Procedure chart table in maintenance order .................. 8-9

(Pentra 60 C+

8-2

1. MAINTENANCE

1.1. Introduction

Customer maintenance has to be carried out according to the

abx pentra 60-c plus analyzer - service manual

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