horiba HEMAPREP RAB316AEN User manual

Blood Spreading System
User Manual
Ref: RAB316AEN

User Manual
User Manual
Ref: RAB316AEN

Contents
Foreword..........................................................................................................................................3
1. Revisions.................................................................................................................................... 4
2. Legal Information....................................................................................................................5
Introduction................................................................................................................................... 9
1. Warning and Precautions.................................................................................................. 10
2. Operational Conditions...................................................................................................... 12
3. Labels and Connections.................................................................................................... 14
Specifications.............................................................................................................................15
1. Intended Use...........................................................................................................................16
2. Principles of Operation.......................................................................................................17
3. Performance Characteristics...........................................................................................18
Workflow........................................................................................................................................19
1. General Recommendations..............................................................................................20
2. Adjusting the System before Operation...................................................................... 22
3. Performing the Test............................................................................................................. 24
Maintenance and Troubleshooting............................................................................ 27
1. Cleaning Procedure............................................................................................................. 28
2. Replacement Procedures..................................................................................................29
3. Troubleshooting Procedures........................................................................................... 31
User Manual
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ii User Manual
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Foreword
1. Revisions.................................................................................................................................... 4
2. Legal Information....................................................................................................................5
2.1. Declaration of Conformity.............................................................................................................. 5
2.2. Notice of Liability............................................................................................................................5
2.3. Trademarks.................................................................................................................................... 5
2.4. Graphics.........................................................................................................................................5
2.5. Document Symbols........................................................................................................................6
2.6. Typographical Conventions........................................................................................................... 6
2.7. Copyright ©2016 by HORIBA ABX SAS....................................................................................... 6
User Manual
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1. Revisions
Reference Internal Reference Document Date Issued
RAB316AEN November 2016
This document is only available online at www.horiba-abx.com/documentation.
Foreword
Revisions
4 User Manual
Ref: RAB316AEN

2. Legal Information
2.1. Declaration of Conformity
This product complies with the Standards and Directives named in the Declaration of Conformity.
The latest version of the EC Declaration of Conformity for this product is available on www.horiba-
abx.com/documentation.
2.2. 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 this manual, HORIBA Medical 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 not following the instructions contained in this manual, or by using the
hardware products described herein in a manner inconsistent with our product labelling.
2.3. Trademarks
Other product names mentioned within this publication may be trademarks or registered trademarks
of their respective owners.
2.4. Graphics
All graphics or photographs are for illustration purposes only and are not contractual.
Foreword
Legal Information
User Manual
Ref: RAB316AEN
5

2.5. Document Symbols
To alert the operator of potentially hazardous conditions, symbols described in this chapter are
provided wherever necessary throughout the manual.
Emphasizes information that must be followed to avoid hazard to either the operator or the
environment, or both.
Emphasizes information that must be followed to avoid possible damage to the system.
Emphasizes information that can be helpful to the operator before, during or after a
specific operational function.
Gives a summary of what can be achieved if the task is performed.
2.6. Typographical Conventions
Before you start using this documentation, you should become familiar with the following
typographical conventions.
More information on
www.horiba-abx.com/documentation.
External links can be used to retrieve
information from a web site.
The Related information box provides clickable
internal links to navigate throughout the user
manual.
2.7. Copyright ©2016 by HORIBA ABX SAS
All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of HORIBA Medical.
Foreword
Legal Information
6 User Manual
Ref: RAB316AEN

HORIBA ABX SAS
Parc Euromédecine - Rue du Caducée
B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: [phone]
Fax: [phone]
Foreword
Legal Information
User Manual
Ref: RAB316AEN
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Foreword
Legal Information
8 User Manual
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Introduction
1. Warning and Precautions.................................................................................................. 10
1.1. Limited Warranty.......................................................................................................................... 10
1.2. Operational Precautions...............................................................................................................11
1.3. Biological Hazard......................................................................................................................... 11
1.4. Graphics and Symbols.................................................................................................................11
2. Operational Conditions...................................................................................................... 12
2.1. Environmental Protection.............................................................................................................12
2.2. Installation.................................................................................................................................... 12
2.3. Package....................................................................................................................................... 12
3. Labels and Connections.................................................................................................... 14
3.1. Serial Number Label.....................................................................................................................14
3.2. Warnings and Biological Hazards Labels.................................................................................... 14
User Manual
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1. Warning and Precautions
This system must be operated as instructed in the user manual. Any other use might compromise
system integrity and might be hazardous for the operator.
This system complies with Standards and Directives named in the Declaration of Conformity. The
latest version of the Declaration of Conformity for this system is available online at www.horiba-
abx.com/documentation.
■The accessories stipulated by HORIBA Medical have been validated in accordance
with the European Directive for in vitro medical devices (98/79/EC).
■The use of some other accessories may place the performance of the system at risk,
thus engaging user responsibility. In this case, HORIBA Medical takes no responsibility
for the system nor for the results rendered.
■Disposable gloves, eye protection and lab coat must be worn by the operator.
■Local or national regulations must be applied in all the operations.
1.1. Limited Warranty
The duration of warranty is stipulated in the Sales conditions associated with the purchase of this
system. To validate the warranty, ensure the following is adhered to:
■The system is operated under the instructions of this manual.
■Maintenance must be done by recommendation from HORIBA Medical using only approved spare
parts.
■The system is operated according to HORIBA Medical recommendations.
■Proper tools are used when maintenance or troubleshooting operations are performed.
If this system has been supplied to you by anyone other than HORIBA Medical or an
authorized representative, HORIBA Medical cannot guarantee this product in terms of
specification, latest revision and latest documentation. Further information may be
obtained from your authorized representative.
Introduction
Warning and Precautions
10 User Manual
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1.2. Operational Precautions
■Gently manipulate the front lever.
■When using frosted slides, make sure frosted portion is facing front. If not, spreader blades come
into contact with frosting and become nicked.
■Clean the spreader blades between each operation especially if an excess of blood was applied
on the slides, to prevent carry-over.
■Carefully handle the slides.
1.3. Biological Hazard
Consider all specimens that contain human specimen extracts 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
biosafety practices as specified in OSHA Blood borne Pathogens Rule (29 CFR part
1910. 1030) or equivalent biosafety procedures.
All accessible surfaces of the system can be potentially contaminated by human
specimens. Disposable gloves and lab coat must be worn by the operator. Local and
national regulations must be applied in all the operations.
1.4. Graphics and Symbols
In Vitro Diagnostic medical
device
This product conforms to the EC Directives
named in the Declaration of Conformity
Manufacturer Biological hazard
Packaging recycling mark Consult Instruction for Use
Related information:
■To Clean the Spreader Blades, p.25
Introduction
Warning and Precautions
User Manual
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2. Operational Conditions
2.1. Environmental Protection
Used Accessories and Consumables Disposal
Disposable used accessories and consumables must be collected by a laboratory specialized in
elimination and recycling of this kind of material according to the local legislation.
System Disposal
This product should be disposed of in accordance with local and applicable country specific
standards.
If any doubt, please contact your local representative.
2.2. Installation
Package content:
■HEMAPREP
■Spreader blades
Only HORIBA Medical approved accessories should be used with the HEMAPREP.
2.3. Package
Factory package of the system HEMAPREP and its implements consists of firm corrugated cardboard
and polyethylene foil. Package protects the system and its implements from adverse factors of
outside environment.
Introduction
Operational Conditions
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The system must be transported in its original factory package.
After unpacking, we recommend you to:
■Visually check the system
■Check the spread quality on first using
Introduction
Operational Conditions
User Manual
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13

3. Labels and Connections
3.1. Serial Number Label
The serial label is located below the system.
3.2. Warnings and Biological Hazards Labels
Warning! Biological hazard
Front of the system
Risk: the specimens containing human specimen
extracts are potentially infectious; all accessible
surfaces of the system can be potentially
contaminated.
How to avoid the risk: wear suitable protective
gloves and handle glasses carefully.
Introduction
Labels and Connections
14 User Manual
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Specifications
1. Intended Use...........................................................................................................................16
2. Principles of Operation.......................................................................................................17
3. Performance Characteristics...........................................................................................18
User Manual
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1. Intended Use
The HEMAPREP is a mechanical system designed to emulate the manual method of preparing
peripheral blood films by the wedge technique.
The system was created for both stationary or portable use.
■As stationary use, it is valuable for preparations in laboratories or at fixed locations.
■As portable use, it is valuable for specimens preparation at patients bedside.
You can use both frosted end and clear slides.
Specifications
Intended Use
16 User Manual
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