ABX Pentra 80 RAB108EA User manual

User Manual
P/n: RAB108EA
ABX Diagnostics
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE

2
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.
▼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 thismanual, ABX Diagnostics will not assume any liability to any persons or entities with
respect to 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.
▼Trademarks
◆Microsoft and Windows are registered trademarks of Microsoft Corporation
◆Other product names mentioned within this publication may be trademarks or registered trademarks of other com-
panies.
▼Graphics
All graphics including screens and printouts, photographs are for illustrations purposes only and are not contractual.
▼Potentials hazards
To alert the operator of potentially hazardous conditions, one of the bold captioned headings which are described
below is provided wherever necessary throughout this text.
Flags a procedure that if not followed properly, can prove to be extremely hazardous to either the operator
or the environment or both.
Emphasizes an operating procedure that must be followed to avoid possible damage to the instrument or
erroneous test results.
Emphasizes the important information especially helpful to the operator before, during or after a specific
operational function.
▼Copyright ®2000 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
Index Technical note Software revision Section Date
RAB108BA V 1.0 All 17/06/02
RAB108CA RAH 912 AA V1.01 All 01/08/02
RAB108DA RAH 938 AA V1.1 4 and 8 16/12/02
RAB108DB ECR1354 UL Correction 801/09/03
RAB108EA RAH 986 AA V1.3.0 + CE Ivd labelling corrections All 07/11/03

1
Section1: Introduction
1. Warning and precautions................................................ 1-2
1.1. Limited guarantee ..................................................................1-2
1.2. Safety Precautions..................................................................1-3
1.3. graphics and symbols.............................................................1-4
2. Labels ............................................................................. 1-5
2.1. Input/Output Labels...............................................................1-5
2.2. PC connections label.............................................................1-7
3. Operational conditions ................................................... 1-8
3.1. Environment ..........................................................................1-8
3.2. Location.................................................................................1-8
3.3. Grounding.............................................................................1-9
3.4. Humidity/Temperature conditions..........................................1-9
3.5. Electromagnetic environment check ......................................1-9
3.6. Environmental protection.......................................................1-9
3.7. Transportation and storage conditions..................................1-10
3.8. Installation...........................................................................1-10
3.9. Interconnections ..................................................................1-11
3.10. Racks.................................................................................1-12
4. Software overview......................................................... 1-13
4.1. Generic toolbar description .................................................1-14
4.2. Contextual toolbar description.............................................1-15
4.3. Main Menu description........................................................1-16
4.4. Miscellaneous......................................................................1-17
5. Workflow overview....................................................... 1-21
5.1. Order overview....................................................................1-21
5.2. Worklist overview................................................................1-23
5.3. Runs and results overview....................................................1-24
5.4. Archives overview ...............................................................1-25
5.5. Results production ...............................................................1-27
6. Printer........................................................................... 1-28

2
Section 2: Daily Guide
1. Instrument Startup........................................................... 2-2
1.1. Waste levels...........................................................................2-2
1.2. Printer start up .......................................................................2-2
1.3. Pentra 80 Startup ...................................................................2-2
1.4. Status.....................................................................................2-5
2. Running the ABX Quality Control ................................... 2-6
2.1. Closed tube Mode with barcode............................................2-6
2.2. Open tube .............................................................................2-7
3. Running specimen .......................................................... 2-9
3.1. Sample identification with internal barcode reader ................2-9
3.2. Non-identified sample with external barcode reader..............2-9
3.3. Stat mode.............................................................................2-11
3.4. Run in progress....................................................................2-12
4. Results .......................................................................... 2-13
4.1. Printing a result series ..........................................................2-13
4.2. Unmatched results...............................................................2-14
5. Archives........................................................................ 2-15
5.1. Searching results by day.......................................................2-15
5.2. Searching results by patient..................................................2-15
6. Instrument Shutdown .................................................... 2-16
6.1. Manual shutdown................................................................2-16

3
Section 3: Quality Assurance & Logs
1. Quality control................................................................ 3-4
1.1. Access to the Quality Control Menu ......................................3-4
1.2. L.J. Graphs.............................................................................3-6
1.3. QC data screen grid...............................................................3-7
1.4. Graphics screen.....................................................................3-8
1.5. Print, send or delete results ....................................................3-9
1.6. New blood control setup .....................................................3-10
1.7. Running control blood.........................................................3-13
2. Patient Quality Control (XB).......................................... 3-14
2.1. Access to the XB menu ........................................................3-15
2.2. XB Graphs ...........................................................................3-16
2.3. XB Data Grid screen ............................................................3-17
2.4. Batch content.......................................................................3-18
2.5. XB limits ..............................................................................3-19
3. Within run .................................................................... 3-20
3.1. Accessing the Within Run Data Grid....................................3-20
3.2. Closed tube sample setting...................................................3-22
3.3. Running cycles ....................................................................3-22
4. Calibration.................................................................... 3-25
4.1. Accessing the Calibration Main Menu..................................3-25
4.2. Target values........................................................................3-26
4.3. Running calibration .............................................................3-27
5. Logs.............................................................................. 3-32
5.1. Access to «Logs» function....................................................3-32
5.2. Calibration logs....................................................................3-34
5.3. Quality control logs .............................................................3-34
5.4. Reagent logs ........................................................................3-35
5.5. Settings logs.........................................................................3-35
5.6. Maintenance logs.................................................................3-35
5.7. Error logs .............................................................................3-35
5.8. Host logs..............................................................................3-35
5.9. Blank cycle logs...................................................................3-35
5.10. Patient logs........................................................................3-36

4
Section 4: Workflow
1. Workflow........................................................................ 4-3
1.1. Sample tube management......................................................4-3
1.2. Workflow...............................................................................4-4
1.3. Worklist.................................................................................4-4
1.4. Sample identification .............................................................4-5
1.5. Barcode Identification............................................................4-5
1.6. Sample identification on Rack/position ..................................4-8
1.7. Exception management........................................................4-11
1.8. Sample tube and order association.......................................4-13
1.9. Patient file management.......................................................4-13
1.10. Loading Worklist from the LIS............................................4-13
2. Worklist........................................................................ 4-14
2.1. Overview.............................................................................4-14
2.2. Accessing the Worklist function...........................................4-14
2.3. Worklist grid........................................................................4-15
2.4. Rack view............................................................................4-20
3. Sample collection & mixing ......................................... 4-24
3.1. Recommended anticoagulant ..............................................4-24
3.2. Blood sample stability..........................................................4-24
3.3. Microsampling.....................................................................4-24
3.4. Mixing .................................................................................4-24
4. Running specimens....................................................... 4-25
5. Run results and associated Flags.................................... 4-26
5.1. Printer output format............................................................4-26
5.2. Result screen........................................................................4-27
5.3. Flags ....................................................................................4-29
6. Order & sample run association.................................... 4-47
6.1. Reviewing sample results.....................................................4-47
6.2. Result /order association ......................................................4-53
7. Results Archives............................................................ 4-55
7.1. Accessing the Results Archives.............................................4-55
7.2. Daily result Description .......................................................4-56
7.3. Patient Result.......................................................................4-58
7.4. Reviewing a result in full screen mode.................................4-60

5
Section 5: Settings
1. Menu «Settings» overview............................................... 5-3
1.1. Accessing the «Settings» menu...............................................5-3
1.2. Menu Settings functions.........................................................5-4
2. Soft parameters ............................................................... 5-5
2.1. Accessing the Soft Parameters menu ......................................5-5
2.2. General tab............................................................................5-6
2.3. Department/Physicians tab.....................................................5-8
2.4. Units tab................................................................................5-9
3. Quality assurance settings............................................. 5-11
3.1. Accessing the QA settings....................................................5-11
3.2. XB options...........................................................................5-11
3.3. Number of calibration runs..................................................5-12
3.4. Coefficients of variation ranges ............................................5-12
4. Rules............................................................................. 5-13
4.1. Accessing the «Rules» screen...............................................5-13
4.2. Rerun conditions..................................................................5-13
4.3. Print conditions....................................................................5-15
4.4. Transmit conditions .............................................................5-16
5. System .......................................................................... 5-17
5.1. Accessing the «System» screen ............................................5-17
5.2. Local settings .......................................................................5-17
5.3. Communication...................................................................5-19
5.4. Printer..................................................................................5-21
5.5. Cycle option........................................................................5-25
6. Save and restore............................................................ 5-26
6.1. Access to «Save/Restore» screen ..........................................5-26
6.2. Configuration.......................................................................5-26
6.3. Dump database....................................................................5-27
6.4. Update of the Help on line of P80 software .........................5-28
7. User profiles.................................................................. 5-30
7.1. Accessing the User screen....................................................5-30
7.2. User menu function keys .....................................................5-31
7.3. Creating a new «User» profile..............................................5-31
8. Sample Types................................................................ 5-33

6
8.1. Accessing the «Types» parameters menu .............................5-33
8.2. Pathological limits ...............................................................5-36
8.3. Alarms & Curve thresholds...................................................5-37
8.4. Age range ............................................................................5-41

7
Section 6: DescriptionTechnology
1. Pentra 80 description ......................................................6-2
1.1. Front View.............................................................................6-2
1.2. Left side view.........................................................................6-2
1.3. Right side view ......................................................................6-3
1.4. Stat tube holder......................................................................6-3
1.5. Rear view...............................................................................6-4
2. Automatic mode principles............................................. 6-5
3. Measuring principles....................................................... 6-9
3.1. Multi distribution sampling sytem (MDSS)..............................6-9
3.2. CBC detection principles .....................................................6-11
3.3. WBC and differential count..................................................6-15

8
Section7: Maintenance & Troubleshooting
1. Maintenance & Troubleshooting procedures................... 7-3
1.1. Hydraulic cycles maintenance chart table..............................7-3
1.2. Maintenance procedures........................................................7-3
1.3. Instrument general cleaning...................................................7-4
2. .Replacement procedures................................................ 7-5
2.1. Reagent replacement .............................................................7-5
2.2. Optical bench lamp replacement.........................................7-11
2.3. Sampling probe replacement ...............................................7-13
2.4. Rinse chamber filter cleaning...............................................7-15
2.5. Instrument Rinse ..................................................................7-16
3. Instrument panels & cover Removals............................. 7-18
3.1. Left front door removal ........................................................7-18
3.2. Right front door removal......................................................7-19
3.3. Right-hand side panel removal.............................................7-19
3.4. Left-hand side panel removal...............................................7-20
4. Service menu description.............................................. 7-21
5. Super User menu description........................................ 7-22
5.1. Mechanical menu................................................................7-23
5.2. Hydraulical menu................................................................7-30
5.3. Others..................................................................................7-35
6. Troubleshooting............................................................ 7-36
6.1. Instrument operation mode..................................................7-37
6.2. Results .................................................................................7-38
6.3. Flags ....................................................................................7-40
7. Hydraulic Diagram ....................................................... 7-42
8. Error messages .............................................................. 7-43
8.1. Analyzer error types and help messages...............................7-44
8.2. Transfer error types and help messages ................................7-45
8.3. STAT mode error type and help message .............................7-46
8.4. Environment Error Types and Help Messages.......................7-46
8.5. User Error Types and Help Messages ...................................7-49
8.6. Expiration Date Error Types and Help Messages...................7-49
8.7. Analyzer Internal Error Types and Help Messages................7-49

9
Section 8: Specifications
1. Technical specifications.................................................. 8-2
1.1. Parameters.............................................................................8-2
1.2. Throughput Analyses .............................................................8-3
1.3. Tube identification.................................................................8-4
1.4. Reagents ................................................................................8-4
1.5. Internal Computer..................................................................8-4
1.6. Measurements and computation............................................8-4
2. Physical specifications .................................................... 8-5
2.1. Power requirements...............................................................8-5
2.2. Operating temperature and humidity .....................................8-5
2.3. Dimension and weight...........................................................8-5
2.4. Minimum specimen volume ..................................................8-5
2.5. dilution ratios.........................................................................8-5
2.6. HGB measurement ................................................................8-5
2.7. Counting aperture diameters..................................................8-5
2.8. Reagent consumption (ml) .....................................................8-6
2.9. Recommended Anticoagulant................................................8-6
3. Summary of performance data*....................................... 8-7
3.1. Precision (Reproducibility).....................................................8-7
3.2. Precision (Repeatability).........................................................8-8
3.3. Linearity.................................................................................8-9
3.4. Carryover.............................................................................8-10
3.5. Normal Ranges....................................................................8-11
3.6. Accuracy .............................................................................8-11
3.7. Leukocyte differential count.................................................8-12
3.8. Sample stability study ..........................................................8-12
3.9. Waste handling precautions.................................................8-13
4. Limitations.................................................................... 8-14
4.1. Maintenance........................................................................8-14
4.2. Blood specimens..................................................................8-14
4.3. Known interfering substances...............................................8-14
5. Reagent Specifications .................................................. 8-18
5.1. Reagent Leaflets...................................................................8-18

10
Section9: Glossary
1. Glossary.......................................................................... 9-2
2. Index............................................................................... 9-4
3. ..................................................................................... 9-11

Introduction
Pentra 80 - User Manual - RAB108EA 1–1
Section 1:Contents
1. Warning and precautions........................................ 1-2
1.1. Limited guarantee........................................................1-2
1.2. Safety Precautions .......................................................1-3
1.3. graphics and symbols ..................................................1-4
2. Labels..................................................................... 1-5
2.1. Input/Output Labels.....................................................1-5
2.2. PC connections label...................................................1-7
3. Operational conditions........................................... 1-8
3.1. Environment................................................................1-8
3.2. Location......................................................................1-8
3.3. Grounding...................................................................1-9
3.4. Humidity/Temperature conditions ...............................1-9
3.5. Electromagnetic environment check............................1-9
3.6. Environmental protection ............................................1-9
3.7. Transportation and storage conditions .......................1-10
3.8. Installation.................................................................1-10
3.9. Interconnections........................................................1-11
3.10. Racks.......................................................................1-12
4. Software overview................................................ 1-13
4.1. Generic toolbar description.......................................1-14
4.2. Contextual toolbar description...................................1-15
4.3. Main Menu description .............................................1-16
4.4. Miscellaneous ...........................................................1-17
5. Workflow overview.............................................. 1-21
5.1. Order overview .........................................................1-21
5.2. Worklist overview .....................................................1-23
5.3. Runs and results overview.........................................1-24
5.4. Archives overview.....................................................1-25
5.5. Results production.....................................................1-27
6. Printer................................................................... 1-28

Pentra 80
1–2 Pentra 80 - User Manual - RAB108EA
Section 1: Introduction
This section provides important information to get you started with Pentra 80
1. Warning and precautions, page 1-2
2. Labels, page 1-5
3. Operational conditions, page 1-8
4. Software overview, page 1-13
5. Workflow overview, page 1-21
6. Printer, page 1-28
1. Warning and precautions
User manual must be enterely read and personnel trained byABX Diagnostics before attempt-
ing to operate instrument. The user always operates with full knowledge and appreciation of
instrument warnings, alarms and flags.
Always refer to labeling and ABX Diagnostics instructions in order to avoid to compromise
system integrity.
The Pentra 80 responds to the Standards and directives named in the Declaration of Confor-
mity added at the beginning of this manual.
◆The reagents and accessoiries stipulated by ABX Diagnostics have been vali-
dated in accordance 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 perfor-
mance of the instrument, engaging the Users reponsability. In this case, ABX
Diagnostics takes no responsability for the device nor for the results rendered.
◆Disposal gloves, eyes protection and lab coat must be worn by the operator.
Local or national regulations must be applied in all the operations
◆Portable/mobile telephones should not be used in proximity of the instrument.
◆All peripheral devices should be IEC compatible.
1.1. Limited guarantee
The duration of guarantee is stipulated in the Sales conditions associated with the purchase
of 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, using only
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.

Introduction
Warning and precautions
Pentra 80 - User Manual - RAB108EA 1–3
6 - Reagents used are those specified in this user manual.
7 - Proper tools are used when maintenance or troubleshooting operations are performed (See
Section 7, 1.2. Maintenance procedures, page 7-3).
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 informa-
tion may be obtained from your authorised representative.
1.2. Safety Precautions
1.2.1. Electronic and moving parts
The following parts must not be handled or checked by the user:
◆electrical Power supply.
◆electronic circuit boards.
Danger of explosion if battery is not replaced correctly!
When replacing the battery, always use the same and/or equivalent type recommended by the
manufacturer. Dispose of used batteries according tothe manufacturer's specific instructions.
Moving parts: It is strictly forbidden to disable sensors as it may cause operator injuries.
Protection covers must not be opened during instrument operations.
1.2.2. Biological risks
Consider all Specimens, Reagents, Calibrators, Controls, etc… that contain hu-
man blood or serum as potentially infectious! Use established, good laboratory
working practices when handling specimens. Wear protective gear, Gloves, Lab
coats, Safety glasses and/or Face shields, and follow other bio-safety practices
as specified in OSHA Blood borne Pathogens Rule (29 CFR part 1910. 1030) or
equivalent bio-safety procedures.
ABX Diagnostics uses disinfectant product for instrument decontamination (including touch
screen) and highly recommends it to decontaminate your instrument (refer to Section 7,
1.3. Instrument general cleaning, page 7-4), to perform the instrument decontamination
procedure).

Pentra 80
1–4 Pentra 80 - User Manual - RAB108EA
1.3. graphics and symbols
Switch off position Switch on position
Alternating current Manufacturer
In Vitro Diagnostic Medical Device This product conforms to the EEC Standards and Directives named in
the Declaration of Conformity.
Caution, consult accompanying
documents 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 All graphics including screens
and printouts, photographs are
for illustrations purpose only and
are not contractual.

Introduction
Labels
Pentra 80 - User Manual - RAB108EA 1–5
2. Labels
2.1. Input/Output Labels
Fig. 1–1 Rear panel labels
2.1.1. Identification label
Fig. 1–2 Serial number label

Pentra 80
1–6 Pentra 80 - User Manual - RAB108EA
2.1.2. Reagent and waste connection labels
◆Waste output: Connection used for Waste output tubing (on Waste position).
◆Waste level detection: Connection used for Waste level detection (on Waste Alarm posi-
tion)
◆Diluent input: Connection used for Diluent input tubing (on Diluent position).
Fig. 1–3 Reagent and waste label
2.1.3. Output label
Fig. 1–4 Ouput Label
1- RS 232 output: LIS (Laboratory Information System) connection.
2- Printer connection: Do not connect any printer which has not been recommended
by an ABX Diagnostics qualified engineer.

Introduction
Labels
Pentra 80 - User Manual - RAB108EA 1–7
2.2. PC connections label
Fig. 1–5 Internal PC connections
1 - Mouse
2 - Keyboard
Refer to 3.9. Interconnections, page 1-11, for other peripheral connections.

Pentra 80
1–8 Pentra 80 - User Manual - RAB108EA
3. Operational conditions
3.1. Environment, page 1-8
3.2. Location, page 1-8
3.3. Grounding, page 1-9
3.4. Humidity/Temperature conditions, page 1-9
3.5. Electromagnetic environment check, page 1-9
3.6. Environmental protection, page 1-9
3.7. Transportation and storage conditions, page 1-10
3.8. Installation, page 1-10
3.9. Interconnections, page 1-11
3.10. Racks, page 1-12
3.1. Environment
The operation of the Pentra 80 should be restricted to indoor location use only! Operation
of the instrument at altitudes of over 3000 Meters (9800 feet) is not recommended. The in-
strument is designed for safety from voltages surges according to INSTALLATION CATEGORY II
and POLLUTION DEGREE 2 (IEC EN 61010-1).
Please contact your local ABX Diagnostics representative for information regarding operation
locations, when it does not comply with the recommended specifications.
3.2. Location
The Pentra 80 should be placed on a clean and leveled table or workbench.
Please note that the Pentra 80 and printer weigh approximately 55 kilograms (121 lbs).
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 as
a centrifuge, etc...
Provide a space of at least 20 cm (8 inches) at the back of the instrument for arranging the
power 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 for easy accessibility to these items