bioMerieux VIDAS User manual

Ref : 99762
Version B
12/2005
VIDAS®
Instrument User’s Manual
bioMérieux®SA 69280 Marcy l'Etoile / France
Tel. [phone] - Fax [phone]
http://www.biomerieux.com
Printed in France / 673 620 399 RCS Lyon
© 2005. bioMerieux, SA

V. AG 06.2005 en
Argentina
bioMérieux Argentina
Av. Congreso 1745
(C1428BUE) Capital Federal
Buenos Aires
tel. [phone]
fax [phone]
Australia
bioMérieux Australia P/L
Unit 25, Parkview Business Center
1 Maitland Place
Baulkham Hills NSW 2153
tel. [phone]
fax [phone]
Austria
bioMérieux Austria GmbH
Eduard-Kittenberger-Gasse 97
Top 3
A-1230 Wien
tel. [phone]
fax [phone]
Belgium
bioMérieux Benelux s.a./n.v.
Media Square
18-19 Place des Carabiniers
Bruxelles 1030
tel. [phone]
fax [phone]
Brazil
bioMérieux Brasil SA
Estrada Do Mapua
491 Taquara - Jacarepaguá
CEP 22710 261 Rio de Janeiro R.J
Rio de Janeiro R.J
tel. [phone]
fax [phone]
Canada
bioMérieux Canada, Inc.
7815, Henri-Bourassa West
Saint Laurent, QC
H4S 1P7
tel. [phone]
fax [phone]
Chile
bioMérieux Chile S.A.
Seminario 131
Providencia
Santiago
tel. [phone]
fax [phone]
China
bioMérieux China Limited
17/Floor, Yen Sheng Centre,
64 Hoi Yuen Road,
Kwun Tong
Kowloon - Hong Kong
tel. [phone]
fax [phone]
Colombia
bioMérieux Colombia Ltda
Avenida 15 No. 100-43
Piso 2
Bogotá D.C.
tel. [phone]
fax [phone]
Denmark
bioMérieux Danmark Aps
Smedeholm 13C,
2730 Herlev
tel. [phone]
fax [phone]
Finland
bioMérieux Suomi Oy
Rajatorpantie 41 C
01640 Vantaa
tel. [phone]
fax [phone]
France
bioMérieux SA
69280 Marcy l’Etoile
tel. [phone]
fax [phone]
http://www.biomerieux.com
Germany
bioMérieux Deutschland GmbH
Weberstrasse 8
D-72622 Nürtingen
tel. [phone]
fax [phone]
Greece
bioMérieux Hellas S.A.
Papanikoli 70
15232 Halandri
Athens
tel. [phone]
fax [phone]
Hungary
Representation office
bioMérieux B.V. Hungarian
Reitter Ferenc u. 39-49
1135 Budapest,
Budapest
tel. [phone]
fax [phone]
India
bioMérieux India Pvt. Ltd
D-45, Defense Colony
New Delhi 110 024
tel. [phone]
fax [phone]
Indonesia
bioMérieux Asean
Enseval Building
Kawasan Industri Pulo Gadung - JI. Pulo
Lentut No. 10
Jakarta Timur 13920
tel. [phone]
fax [phone]
Italy
bioMérieux Italia S.p. A
Via Fiume Bianco, 56
00144 Roma
tel. [phone]
fax [phone]
Ivory Coast
bioMérieux Afrique Occidentale
08 BP 2634
Abidjan 08
tel. [phone]
fax [phone]
Japan
bioMérieux Japan, Ltd
Seizan Bldg.,
12-28 Kita-Ayoama 2-chome
Minato-ku,
Tokyo 107-0061
tel. [phone]
fax [phone]
Korea
bioMérieux Korea Co., Ltd
7th Floor Yoosung Building
# 830-67, Yoksam-dong, Kangnam ku
Seoul
tel. [phone]
fax [phone]
Mexico
bioMérieux México SA de CV
Chihuahua 88, col. Progreso
México 01080, D.F.
tel. [phone]
fax [phone]
Netherlands (The)
bioMérieux Benelux BV
Boseind 15
P.O. Box 23
5280 AA Boxtel
tel. [phone]
fax [phone]
New Zealand
bioMérieux New Zealand Ltd
22/10 Airbourne Road
North Harbour
Auckland
tel. [phone]
fax [phone]

Norway
bioMérieux Norge AS
∅kernveien 145
N - 0513 Oslo
tel. [phone]
fax [phone]
Philippines (The)
Representation office
bioMérieux Philippines Rep. Office
11th Floor, Pearlbank Centre
146 Valero Street, Salcedo Village
1227 Makati City
tel. [phone]
fax [phone]
Poland
bioMérieux Polska Sp. Z.o.o.
ul. Zeromskiego 17
01-882 Warszawa
tel. [phone]
fax [phone]
Portugal
bioMérieux Portugal, Lda.
Rua Alto do Montijo,
Lotes 1 e 2 - Portela de Carnaxide
2794-070 Carnaxide
tel. [phone]
fax [phone]
Russia
o.o.o. bioMérieux
Petrovsko-Razoumovskii proyezd, 29
127287 Moscow
tel. [phone]
fax [phone]
Spain
bioMérieux España S.A.
Manual Tovar, 45-47
28034 Madrid
tel. [phone]
fax [phone]
Sweden
bioMérieux Sverige AB
Hantverksvägen 15
436 33 Askim
tel. [phone]
fax [phone]
Switzerland
bioMérieux Suisse s.a.
51, avenue Blanc
Case postale 2150
1211 Genève 2
tel. [phone]
fax [phone]
Taiwan
Representation office
bioMérieux China Limited - Taiwan Branch
RM 608, No. 6-3 Ching Cheng Street
Taipei 105
tel. [phone]
fax [phone]
Thaïland
bioMérieux Thaïland Ltd
Regent House Bldg, 16 th Floor
183 Rajdamri Road, Lumpini, Pathumwan
Bangkok 10330
tel. [phone]
fax [phone]
Turkey
bioMérieux Diagnostik A.S.
Değirmen Sok. Nida Plaza Kat:6
34742 Kozyataği / Istanbul
tel. [phone]
fax [phone]
United Kingdom
bioMérieux UK Ltd
Grafton Way, Basingstoke
Hampshire RG22 6HY
tel. [phone]
fax [phone]
USA
bioMérieux, Inc.
100 Rodolphe Street
Durham NC 27712
tel. [phone]
fax [phone]
Vietnam
Representation office
bioMérieux Vietnam Rep. Office
17 Nguyen Van Mai, Ward 8
District 3
Ho Chi Minh City
tel. [phone]
fax [phone]
Distribution in over 130 countries

V.B 02/2005
This manual is periodically updated. The updates shall be included in the new
releases of the Software.
Information supplied in this manual may be subject to modifications before the
products described become available.
This manual may contain information or references relating to certain
bioMérieux®SA products, software or services which are not available in the country
of release; this shall not mean that bioMérieux SA intends to market such products,
software or services in such country
To request copies of publications or for any technical request, contact bioMérieux SA
or your local distributor.
Liability disclaimer
This manual is provided “AS IS” without any warranty, whether express or
implied, of merchantability, safety, quality, accuracy, performance of products
described on this manual, including an implied warranty of merchantability or
fitness for a particular purpose, non infringement of third parties intellectual
property rights and against an incidental or direct damage.
In no event shall bioMérieux SA be liable for any direct or indirect damage or
consequence related to, arising out of or in connection with, any use of this
manual and/or its results by the User and/or any third party.
In no event shall this manual be construed as an undertaking of bioMérieux SA,
who reserves the right to modify this manual without notice and shall incur no
liability as a result of such modification.
This manual is provided for information purposes only and except for the
present provisions does not constitute a binding document legally.
Intellectual Property
bioMérieux SA is the sole owner of copyright, patrimonial rights and any other
intellectual property rights in and to this manual and its content subject to
possible third parties rights.
This manual and its content are protected under the provisions of section L.111-1
and following articles of the French Intellectual Property Code and International
Copyright and Author Rights Treaties.
The rights to use this manual granted herein are non-exclusive and limited to the
extent necessary to use the Software and Instrument. In no event shall the
Users be granted herein any other right to use this manual including without
limitation, the right to reproduce, represent, adapt or translate all or part of this
manual by any mean whatsoever and in any country without the prior written
consent of bioMérieux SA.
Any use of this manual other than expressly permitted hereunder shall be
prosecuted.
IMPORTANT! USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE CLAUSES
ABOVE MENTIONED.

bioMérieux, the blue logo and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux SA
or one of its subsidiaries.
Windows is a used, pending and/or registered trademark belonging to Microsoft Corporation.
Dacron is a used, pending and/or registered trademark belonging to Invista North America, SARL.
7X is a used, pending and/or registered trademark belonging to MP Biomedicals, LLC.
Alconox and Liquinox are used, pending and/or registered trademarks belonging to Alconox, Inc.

V.B 02/2005
General Warnings
DANGER! All biological fluids should be considered as potentially infectious.
Protective gloves must be worn when manipulating blood, products
derived from blood or objects contaminated with blood.
Qualified laboratory personnel should use acceptable procedures for
biohazardous material.
IMPORTANT! The configuration that you have purchased is adapted to the legislation
and standards of the different countries it will be sent to.
For this reason, it may differ from the one presented in this document.
However, it will not prevent VIDAS®from operating correctly.
This product is an in vitro diagnostic medical device. It complies with the
directives and standards mentioned in the certificate supplied with it.
The user is advised to read and understand all instructions in this manual
to be able to derive the best performance from the VIDAS.
bioMérieuxSA recommends that you observe the different warnings
inscribed on the instrument itself and indicated in the documentation
supplied.
The accuracy of results obtained with this instrument depends, in
particular, on the maintenance operations described in this manual.
The user should be aware that, if the maintenance operations are not
performed, are only partially performed, or are not performed as described
in this manual, bioMérieux SA is in no case liable for any false test results
obtained.
bioMérieux SA is in no case liable for any changes made to the equipment
without authorization from bioMérieux SA.

IMPORTANT! Electromagnetic Compatibility (EMC):
This is a Class A product.
In a residential area, this product may cause harmful interference in which
case the user may be required to take adequate measures at his own
expense.
The equipment may also cause inteference if not installed in accordance
with the instructions given in this manual.
This statement only applies to European countries and instruments
bearing the symbol with regard to the waste electrical and electronic
equipment European directive.
You can play an important role in contributing to reuse, recycling and
other forms of recovery of waste electrical and electronic equipment.
Sorting this type of waste significantly reduces potential negative effects
on the environment and human health as a result of the presence of
hazardous substances in electrical and electronic equipment.
At the end of the life cycle of this product, do not dispose of
the product as unsorted municipal waste, even if it is
decontaminated. It is imperative that you contact bioMérieux to
assure for its appropriate disposal.

Revisions
The list of revisions below summarizes replacements or additional pages in your
VIDAS Instrument User’s Manual.
Manual Reason Page(s)
V.A 03.2005 New VIDAS model All
V.B 12.2005 New software version All
VIDAS®Instrument User's manual Revisions-1

Table of Contents
1How to use this manual 1-1
Finding topics and procedures ............................................................................................................. 1-2
Typographic conventions ..................................................................................................................... 1-3
Warnings.............................................................................................................................................. 1-3
Graphic symbols .................................................................................................................................. 1-4
2Functional description 2-1
Description / aim .................................................................................................................................. 2-3
Configuration components ................................................................................................................... 2-4
Hardware........................................................................................................................................ 2-6
Extension potential ....................................................................................................................... 2-11
Consumables ............................................................................................................................... 2-12
General features and technical specifications.................................................................................... 2-17
Environmental conditions ............................................................................................................. 2-17
Physical features .......................................................................................................................... 2-18
Electrical specifications ................................................................................................................ 2-19
Technical specifications ............................................................................................................... 2-20
Temperature control ..................................................................................................................... 2-20
Characteristics of optical components.......................................................................................... 2-21
Assay kit....................................................................................................................................... 2-21
Operating principles ........................................................................................................................... 2-22
Immunoassay methods ................................................................................................................ 2-22
Protocol concept........................................................................................................................... 2-23
Optical system.............................................................................................................................. 2-25
Performance checks / self-tests ......................................................................................................... 2-26
Optical system.............................................................................................................................. 2-26
Pipette mechanisms ..................................................................................................................... 2-28
VIDAS temperature ...................................................................................................................... 2-28
3Getting started 3-1
Recommendations for installation and use .......................................................................................... 3-2
Unpacking the VIDAS .......................................................................................................................... 3-4
Assembly and installation .................................................................................................................... 3-5
Choosing a location........................................................................................................................ 3-6
4Starting the VIDAS 4-1
Switching on......................................................................................................................................... 4-2
Installing the hand-held bar code reader.............................................................................................. 4-3
Preliminary instructions .................................................................................................................. 4-3
Preparing the computer.................................................................................................................. 4-4
VIDAS®Instrument User's manual V-1

Table of Contents
Preparing the reader ...................................................................................................................... 4-8
Connecting the bar code reader ..................................................................................................... 4-8
Configuring the bar code reader................................................................................................... 4-10
Recommendation for use of the bar code reader ......................................................................... 4-11
5Using VIDAS 5-1
Basic VIDAS work flow......................................................................................................................... 5-2
6Maintenance 6-1
Preventive maintenance....................................................................................................................... 6-2
User maintenance................................................................................................................................ 6-3
Tools required ................................................................................................................................ 6-3
Summary of maintenance operations................................................................................................... 6-4
Decontamination of the VIDAS blue..................................................................................................... 6-5
Cleaning the strip preparation tray ................................................................................................. 6-8
Cleaning the reagent strip trays.................................................................................................... 6-10
Cleaning the spill tray ................................................................................................................... 6-12
Reassembling the strip preparation tray and switching the analytical
module back on ............................................................................................................................ 6-13
Using the reagent for testing the pipette mechanisms: Quality Control VIDAS
(QCV) – Reference 30706 ................................................................................................................. 6-13
Decontamination of the VIDAS .......................................................................................................... 6-14
Cleaning the SPR®block.............................................................................................................. 6-15
Cleaning the reagent strip trays.................................................................................................... 6-17
Cleaning the spill tray ................................................................................................................... 6-18
Replacing the front panel and switching the analytical module back on....................................... 6-19
Using the reagent for testing the pipette mechanisms: Quality Control VIDAS
(QCV) – Reference 30706 ................................................................................................................. 6-19
Computer ........................................................................................................................................... 6-20
Cleaning the screen ..................................................................................................................... 6-20
Printer ................................................................................................................................................ 6-22
Cleaning ....................................................................................................................................... 6-22
Replacing the ink cartridge ........................................................................................................... 6-22
Bar code reader ................................................................................................................................. 6-22
Cleaning ....................................................................................................................................... 6-22
7Troubleshooting 7-1
8Glossary 8-1
9Index 9-1
Notes
V-2 VIDAS®Instrument User's manual

List of figures
Functional description
Fig. 2-1: VIDAS configuration .................................................................................................................... 2-2
Fig. 2-2: Configuration components (example).......................................................................................... 2-4
Fig. 2-3: Reagent strip tray ........................................................................................................................ 2-7
Fig. 2-4: Strip preparation tray closed........................................................................................................ 2-8
Fig. 2-5: Opening the strip preparation tray ............................................................................................... 2-8
Fig. 2-6: Reagent strips place on the strip preparation tray ....................................................................... 2-8
Fig. 2-7: Reagent strips placed on the strip preparation tray with its boat ................................................. 2-8
Fig. 2-8: SPR®block.................................................................................................................................. 2-9
Fig. 2-9: Optical cuvette on a reagent strip.............................................................................................. 2-10
Fig. 2-10: Single reagent strip.................................................................................................................. 2-12
Fig. 2-11: Dual reagent strip .................................................................................................................... 2-13
Fig. 2-12: Reagent strip label................................................................................................................... 2-14
Fig. 2-13: Reagent strip dot ..................................................................................................................... 2-14
Fig. 2-14: SPR®....................................................................................................................................... 2-16
Fig. 2-15: Dynamic reactions ................................................................................................................... 2-23
Fig. 2-16: Example of a protocol.............................................................................................................. 2-24
Fig. 2-17: Fluorescent reading................................................................................................................. 2-25
Getting started
Fig. 3-1: Gripping area (only concerns VIDAS blue) .................................................................................. 3-4
Starting the VIDAS
Fig. 4-1: Power switch ............................................................................................................................... 4-2
Fig. 4-2 : Configuration options.................................................................................................................. 4-4
Fig. 4-3 : Configuration details................................................................................................................... 4-5
Fig. 4-4 : Shutting down Windows®........................................................................................................... 4-7
Fig. 4-5 : Shutting down the computer....................................................................................................... 4-7
Fig. 4-6 : Example of a reader configuration sheet .................................................................................. 4-10
Using VIDAS
Fig. 5-1: Basic VIDAS work flow ................................................................................................................ 5-2
Fig. 5-2: Basic VIDAS work flow (cont'd)................................................................................................... 5-3
VIDAS®Instrument User's manual VI-1

List of figures
Maintenance
Fig. 6-1: Opening the section fully ............................................................................................................. 6-6
Fig. 6-2: Cleaning the SPR®block ............................................................................................................. 6-7
Fig. 6-3: Cleaning the rear of the SPR®block............................................................................................ 6-7
Fig. 6-4: Do not clean the seals situated above the SPR®block ............................................................... 6-8
Fig. 6-5: Opening the strip preparation tray ............................................................................................... 6-8
Fig. 6-6: Cleaning the strip preparation tray............................................................................................... 6-9
Fig. 6-7: Dismantling the strip preparation tray ........................................................................................ 6-10
Fig. 6-8: Removing the strip preparation tray........................................................................................... 6-10
Fig. 6-9: Repositioning the strip sections trays ........................................................................................ 6-11
Fig. 6-10: Cleaning the spill tray .............................................................................................................. 6-12
Fig. 6-11: Removing the front panel......................................................................................................... 6-14
Fig. 6-12: Cleaning the SPR®block ......................................................................................................... 6-15
Fig. 6-13: Cleaning the rear of the SPR®block........................................................................................ 6-16
Fig. 6-14: Do not clean the seals situated above the SPR®block............................................................ 6-16
Fig. 6-15: Repositioning the strip sections trays ...................................................................................... 6-17
Fig. 6-16: Cleaning the spill tray .............................................................................................................. 6-18
Fig. 6-17: Replacing the front panel......................................................................................................... 6-19
Fig. 6-18: Shutting down Windows®......................................................................................................... 6-20
Fig. 6-19: Shutting down the computer .................................................................................................... 6-21
Note: Software screens and figures are given for information purposes only.
V-2 VIDAS®Instrument User's manual

1 How to use this manual
Introduction
This manual deals exclusively with the VIDAS equipment and consumables.
The software and procedures for use are described in the VIDAS PC User's
Manual.
The table of contents lists all the chapters of this manual. Each chapter is
subdivided into sections corresponding to a procedure or a precise description.
Answers to questions can easily be found by referring to the table of contents, or
the index at the back of this manual.
WARNING! The user is advised to read and understand all instructions in this manual
to be able to derive the best performance from the VIDAS.
VIDAS®Instrument User's manual 1-1

How to use this manual
Finding topics and procedures
Finding topics and procedures
This manual is divided into nine chapters. The first seven chapters are used for
the description and procedures. Chapter 8 contains the glossary and chapter 9
the index.
Table of contents The main table of contents of the manual is located on pages V-1 to V-2.
It lists each chapter and the procedures and/or topics contained in the manual.
List of figures Page VI-1 contains a list of the figures in this manual.
Graphic symbols The standard symbols used for bioMérieux instruments, and their meanings,
can be found in the list on page 1-4.
Page headers and
page footers
Apart from the first page of every chapter, each page of this manual includes a
page header and a footer.
Each page header includes the chapter title and the title of a procedure or its
corresponding description.
These titles are located on the outside of the page so that you can thumb
through the pages to quickly locate a chapter or a procedure.
The footers contain the title of the manual, the name of the product and the
page number.
Glossary The glossary is located in chapter 8 at the back of the manual. It gives the
definition of the main technical terms used in the manual.
Index The index is located in chapter 9 at the back of the manual. It is used to locate a
particular description or procedure.
Sheet of
decontamination
labels
One of these labels is applied to the equipment to certify that it has been
properly decontaminated:
− before any operation by a service technician,
− before it is returned to the factory, if necessary.
1-2 VIDAS®Instrument User's manual

How to use this manual
Typographic conventions
1
2
3
4
Typographic conventions
The following typographic conventions are used throughout this manual.
•Prepare samples... The bullet point is used to indicate an action to be performed.
This icon is used to indicate specific information concerning the VIDAS
instrument called "VIDAS blue"in the manual.
Unless otherwise specified, the information in the manual applies to the
VIDAS, whichever model is used.
Warnings
The following warnings are used throughout the manual:
− for safety reasons (DANGER!),
− to ensure that VIDAS is maintained in good working condition (CAUTION!),
− or to allow optimum use of your VIDAS (IMPORTANT!or WARNING!).
5
VIDAS®Instrument User's manual 1-3

How to use this manual
Graphic symbols
Graphic symbols
V.A 09/2003 – màj smn –10/2004
The standard symbols used for the bioMérieux systems and their meanings
can be found below:
Direct current
Alternating current
Both direct and alternating current
Three-phase alternating current
Earth (ground) TERMINAL
PROTECTIVE CONDUCTOR TERMINAL
Frame or chassis TERMINAL
Equipotentiality
ON (power supply)
OFF (power supply)
"ON" (only for a component of the system equipment)
1-4 VIDAS®Instrument User's manual

How to use this manual
Graphic symbols
1
2
3
4
5
VIDAS®Instrument User's manual 1-5
"OFF" (only for a component of the system equipment)
Equipment protected throughout by DOUBLE INSULATION or
REINFORCED INSULATION (equivalent to Class II of IEC 536)
Risk of electric shock
Caution: see accompanying documents
High temperature
Potential pinch point
Potential biohazard
i
Consult Instructions for Use
LOT Batch code
or REF Catalogue number
Temperature limitation
EC REP
Authorised representative of the European Community
Keep dry

How to use this manual
Graphic symbols
Manufacturer
Date of manufacture
IVD In Vitro Diagnostic Medical Device
SN or SN Serial number
Keep away from magnetic field
Separate collection for waste electrical and electronic equipment
1-6 VIDAS®Instrument User's manual