HORIBA ABX PENTRA 80 RAA022AA User manual

Technical Manual
P/n: RAA022B

PENTRA 80 TECHNICAL MANUAL RAA022BA
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1. Revisions
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.
1.1. Notice of liability
The information in this manual is distributed on an ’’as is’’ basis, without warranty. While every
precaution has been taken in the preparation of the manual, ABX DIAGNOSTICS shall have any liability to
any person or entity with respect to liability, loss, or damage caused or alleged to be caused directly or
indirectly by the instructions contained in this manual or by the computer software and hardware
products described herein.
1.2. Trademarks
Other product names mentioned within this publication may be trademarks or registered
trademarks of other companies.
1.3. Copyright ®2002 by ABX DIAGNOSTICS
All rights reserved. No part of this book may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of ABX DIAGNOSTICS.
ABX DIAGNOSTICS
Parc Euromédecine
Rue du caducée
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Tel: (33) (0)4 67 14 15 16
Fax: (33) (0)4 67 14 15 17
Table 1: Table of Revisions
Index P/N revision Revision Section Date
RAA022AA RAH912AA <V1.01 All 31/03/02
RAA022B RAH986 XL 80 integration All 30/04/04

INTRODUCTION
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2. Working conditions
2.1. Environment
The Pentra 80 should be operated in an indoor location only. Operation at an altitude over 3000
meters (9800 feet) is not recommended. Instrument is designed to be safe for transient voltages
according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2.
Please ask your ABX Diagnostics representative service center for any information about the operating
location when it does not comply with the recommended specifications.
2.2. Location
The Pentra 80 should be placed on a clean and leveled table or work station. Please note that the
Pentra 80, printer and reagents weigh approximately 40 kilograms (88 lbs). Avoid exposure to sunlight.
Proper ventilation requires that a space of at least 20 cm (8 inches) must be left behind the instrument.
2.3. Grounding
Proper grounding is required. Check that the wall ground (earth) plug is correctly connected to the
laboratory grounding electricity installation.
If there is no ground then use a ground stake. Current electricity Standards must be applied.
2.4. Humidity and temperature conditions
The Pentra 80 must function between 16 to 34°C (61 to 93°F). Maximum relative humidity 80% for
temperatures up to 31°C (88°F) decreasing linearly to 50% relative humidity at 40°C (104°F). If it is kept
at a temperature of less than 10°C (50°F), the instrument should be allowed to sit for an hour at the
correct room temperature before use.
2.5. Electromagnetic environment check
The Pentra 80 as been designed to produce less than the required level of electromagnetic
interferences in order to operate in conformity with its destination. The electromagnetic interferences
caused by the Pentra 80 are limited to a level allowing the correct operation of other instruments in
conformity with their destination.
In case of problems, check that the instrument is not placed in proximity of electromagnetic fields,
or short wave emissions (radars, X-rays, scanner, etc...).
2.6. Environment protection
Used accessories and consumables must be collected by a laboratory specialized in elimination
and recycling of this kind of material according to the legislation.

PENTRA 80 TECHNICAL MANUAL RAA022BA
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Specifications
Section 1: Specifications
1. Technical specifications ..........................................1-2
1.1. Parameters................................................................... 1-2
1.2. Throughput Analyses ................................................... 1-2
1.3. Tube identification ...................................................... 1-2
1.4. Reagents...................................................................... 1-3
1.5. Internal Computer ....................................................... 1-3
1.6. Measurements and computation .................................. 1-3
2. Physical specifications.............................................1-3
2.1. Power requirements..................................................... 1-3
2.2. Operating temperature and humidity ........................... 1-3
2.3. Dimension and weight ................................................ 1-3
2.4. Minimum specimen volume ........................................ 1-4
2.5. dilution ratios .............................................................. 1-4
2.6. Hgb measurement ....................................................... 1-4
2.7. Counting aperture diameters........................................ 1-4
2.8. Reagent consumption (ml) ........................................... 1-4
3. Summary of performance data.................................1-5
3.1. Repeatability ............................................................... 1-5
3.2. Linearity ...................................................................... 1-5
3.3. Carryover .................................................................... 1-5
4. Reagents specification .............................................1-6
4.1. ABX DILUENT............................................................. 1-6
4.2. ABX LYSE .................................................................... 1-6
4.3. ABX BIOLYSE .............................................................. 1-6
4.4. ABX CLEANER............................................................. 1-7
4.5. ABX EOSINOFIX.......................................................... 1-7
4.6. ABX BASOLYSE II........................................................ 1-7
4.7. Waste handling precautions ........................................ 1-8
5. Limitations ..............................................................1-8
5.1. Maintenance ............................................................... 1-8
5.2. Blood specimens ......................................................... 1-8
5.3. Known interfering substances

PENTRA 80 TECHNICAL MANUAL RAA022B
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1. Technical specifications
1.1. Parameters
1.2. Throughput Analyses
• 80 samples per hour.
1.3. Tube identification
• By mean of Keyboard, internal and external Barcode.
Table 1: CBC Mode
WBC White Blood Cell
RBC Red Blood Cell
Hgb Hemoglobin Concentration
Hct Hematocrit
MCV Mean Corpuscular Volume
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration
RDW Red Distribution Width
PLT Platelets
PDW Platelets Distribution Width
MPV Mean Platelet Volume
PCT Plateletcrit
Table 2: CBC + 5DIFF Mode
WBC White Blood Cell
LYM Lymphocytes % and #
MON Monocytes % and #
NEU Neutrophils % and #
EOS Eosinophils % and #
BAS Basophils % and #
LIC Large Immature Cell % and #
ALY Atypical Lymphocytes % and #
RBC Red Blood Cell
Hgb Hemoglobin Concentration
Hct Hematocrit
MCV Mean Corpuscular Volume
MCH Mean Corpuscular Hemoglobin
MCHC Mean Corpuscular Hemoglobin Concentration
RDW Red Distribution Width
PLT Platelets
PDW Platelets Distribution Width
MPV Mean Platelet Volume
PCT Plateletcrit

SECTION 1 SPECIFICATIONS
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1.4. Reagents
• ABX DILUENT (20 Litres).
• ABX CLEANER (1 Litre, Integrated).
• ABX EOSINOFIX (1 Litre, Integrated).
• ABX BASOLYSE (1 Litre, Integrated).
• ABX LYSE (0.4 Litre, Integrated).
1.5. Internal Computer
• Color LCD touch screen: 12 inches.
• Industrial PC board:
.................................Windows NT 4.0. for Pentra 80
................................... Windows XP for Pentra XL80
• Processor frequency ................ Celeron 433 MHz.
• Memory capacity:
................................................128 Mo for Pentra 80
............................................256 Mo for Pentra XL80
• Hard drive ................................................... 20 Go.
• Floppy disck.
• CD ROM drive.
• RS 232C
• USB, Ethernet for Pentra XL80.
• Keyboard.
• Mouse.
1.6. Measurements and computation
• 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 and Pdw.
2. Physical specifications
2.1. Power requirements
• Power supply..................from 100 Vac to 240 Vac.
................................. 50 Hz to 60 Hz.
• Power consumption .................Maximum 230 VA.
• Printer ...................................... Depends of printer.
.............................................. (See printer’s manual).
2.2. Operating temperature and humidity
• 16 - 34°C (61-93°F) room temperature.
• Maximum relative humidity 80% for temperature up to 31°C (88°F) decreasing linearly to 50%
relative humidity at 40°C (104°F).
2.3. Dimension and weight
• Dimensions.................................. 82 x 57 x 54 cm.
........................... 34.1 x 23.3 x 22 in.
• Weight.......................................................... 55 Kg.
............................................. 122 lbs.

PENTRA 80 TECHNICAL MANUAL RAA022B
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2.4. Minimum specimen volume
• CBC Mode (CBC) ...........................................30µl.
• CBC + 5DIFF Mode (DIF)................................53µl.
2.5. dilution ratios
• WBC/BASO.................................................. 1/200.
• LMNE ............................................................. 1/80.
• RBC/PLT .................................................. 1/10000.
• HGB ............................................................. 1/250.
2.6. Hgb measurement
• Hgb chamber, LED 555 nm.
• Modified Drabkin method (cyanmethemoglobin).
• Light source .................. Electroluminescent diode.
• Wavelenght .................................550nm +/- 10nm.
2.7. Counting aperture diameters
• WBC/BASO...................................................80µm.
• LMNE ............................................................60µm.
• RBC/PLT .......................................................50µm.
2.8. Reagent consumption (ml)
Table 3: Reagents consumption
Cycles Estimated
duration (s)
Diluent
(ml)
Eosinofix
(ml)
Basolyse II
(ml)
Cleaner
(ml)
Lyse
(ml)
CBC/DIFF 0’45’’ 27.4 1.0 2.0 1.0 0.45
CBC 0’45’’ 24.4 -2.0 1.0 0.45
Prime DILUENT 3’00’’ 44 - - - -
Prime
EOSINOFIX 1’34’’ 1.6 23.7 - - -
Prime
BASOLYSE 2 1’25’’ 1.7 -23.7 1.0 -
Prime CLEA-
NER 1’24’’ 1.7 - - 24.7 -
Prime LYSE 1’31’’ 2.7 - - - 8.4
Prime ALL 7’13’’ 50.7 24.0 24.0 25.0 8.4
STARTUP
(1 blank cycle) 2’28’’ 55.2 2.0 3.0 2.0 0.95
SHUT DOWN 2’56’’ 32.2 1.0 1.0 14.2 0.49
Rinse
CYTOMETER 1’14’’ 5.0 - - - -
AUTOCLEAN 1’33’’ 27.6 1.0 1.0 1.0 0.50
MINICLEAN 0’21’’ 10.3 1.0 2.0 1.0 0.33
CONCENTRA-
TED cleaning 4’00’’ 29.6 1.0 1.0 1.0 0.50
BACKFLUSH 0’24’’ - - - - -

SECTION 1 SPECIFICATIONS
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STARTUP cycle estimated duration and consumptions are given for one blank cycle control. It
could be a maximum of three cycles.
3. Summary of performance data
3.1. Repeatability
• Based on 10 consecutive samples of the same fresh whole blood sample without alarm:
3.2. Linearity
3.3. Carryover
• Carry-over was tested by analyzing samples with hight concentration of WBCs, RBCs, Hgb and
PLTs. Each sample was run in triplicate, followed by three background cycles. The % carryover is
calculated using the following formula:
Table 4: Repeatibility
PARAMETERS %CV Test Level
WBC < 2% at 10 x 103/µL
RBC < 2% at 5 x 106/µL
Hgb < 1% at 15 g/dL
Hct < 2% at 45%
Plt < 5% at 300 x 103/µL
Table 5: Linearity
PARAMETERS Linearity Range Difference
(Which ever is greater)
WBC (103/µL) 0 to 120 x 103/µL +/- 0.3 or +/- 7%
RBC (106/µL) 0 to 8 x 106/µL +/- 0.07 or +/- 2%
RBC (106/µL) 8 to 18 x 106/µL Reportable range
PLT (103/µL) 0 to 1 900 x 103/µL +/- 10 or +/- 7%
PLT Concentrated mode (103/µL) 1500 to 5000 x 103/µL +/- 10 or +/- 7 %
HGB (g/dl) 1.3 to 24 g/dl +/- 0.3 or +/- 2%
HCT (%) 2 to 67 % +/- 2 or +/- 3%
Table 6: Carryover
WBC RBC Hgb PLT
Level 43.64 8.56 25.94 739
% Carryover (Actual) 0.00 0.00 0.05 0.28
% Carryover (Claimed) <0.5% <0.5% <0.5% <0.5%
Carryover Background1 Background3–
Sample3 Background3–
-------------------------------------------------------------------------x100=

PENTRA 80 TECHNICAL MANUAL RAA022B
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4. Reagents specification
In order for the instrument to operate correctly, hight-quality reagents must be used.
ABX DIAGNOSTICS provides all the necessary reagents.
All these reagents have been registered by the A.F.S.S.A.P.S. «Agence Française de Sécurité
Sanitaire des Produits de Santé» according to the procedure relative to laboratory reagents
used for biological analyses.
These reagents are used for in vitro diagnostics.
All these reagents are manufactured by:
ABX DIAGNOSTICS
Rue du caducée - Parc Euromédecine
34184 MONTPELLIER CEDEX - FRANCE
Tel: [phone] - Fax: [phone]
4.1. ABX DILUENT
• Function: This diluent is necessary for the process involved in counting (and differentiating) the
blood cells. This reagent is used also to rinse the hydraulic parts of the instrument.
• Composition: Stabilized saline solution which contains an organic buffer, an antiseptic and
Sodium Azide < 0.1%.
• Description: Limpid and odourless aqueous solution.
• Physico-chemical properties: Boiling point: About 100°C, pH: neutral.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Handling Precautions: Avoid skin and eye contact. Use laboratory gloves when handling the
reagents. If a large quantity of reagent is ingested a mucous irritation can result.
• Emergency First aid: If the eyes or skin come into contact with the reagent, rinse thoroughly with
water. If a large quantity is ingested, drink water immediately, and induce vomiting.
• Storage conditions: Stored at 18°C (65°F) to 25°C (77°F) away from light.
• ABX DIAGNOSTICS Part number: 0901020
4.2. ABX LYSE
• Function: This reagent is used to lyse blood cells and determine hemoglobin concentration.
• Composition:The reagent contains potassium cyanide at 0.03%, a quarternary ammonium salt
and a saline phosphate buffer containing sodium azide < 0.1%.
• Description: Aqueous solution, limpid.
• Physico-chemical properties: Boiling point: approximately 100°C. pH: basic, smells of cyanide.
• Mesuring Principles: See user manual.
• Performances: See user manual.
• Results: See user manual.
• Directions for use: See user manual.
• Handling Precautions: May be dangerous. Avoid contact with eyes, skin and clothing. Wear
laboratory gloves when handling the product. The product may be harmful if ingested. The product
can be absorbed through an open wound, or inhalation.
• Emergency First aid: If the eyes or skin come into contact with the reagent, rinse with water. If
the reagent is inhaled, breathe fresh air immediately. If a large quantity is ingested, drink water
immediately, and induce vomiting. Call anti-poison center, or contact doctor.
• Storage conditions: Stored at 18°C (65°F) to 25°C (77°F) away from light. Product will degrade if
exposed to air, keep cap / probe assembly securely tightened.
• ABX DIAGNOSTICS Part number: 0906004
4.3. ABX BIOLYSE
• Function: This reagent is used to lyse blood cells and determine hemoglobin concentration.
• Composition:Quarternary ammonium chloride.