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]

Distribution in over 130 countries

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]

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
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
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.

®

SA products, software or services which are not available in the country

bioMérieux SA be liable for any direct or indirect damage or

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

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.

®

from operating correctly.

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
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.

symbol with regard to the waste electrical and electronic

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

V.B 12.2005

New VIDAS model

New software version

All

All

VIDAS

®

Instrument User's manual Revisions-1

Table of Contents

1 How to use this manual 1-1

Finding topics and procedures ............................................................................................................. 1-2

Typographic conventions ..................................................................................................................... 1-3

Warnings.............................................................................................................................................. 1-3

Graphic symbols .................................................................................................................................. 1-4

2 Functional 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

3 Getting 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

4 Starting 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

5 Using VIDAS 5-1

Basic VIDAS work flow......................................................................................................................... 5-2

6 Maintenance 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

7 Troubleshooting 7-1

8 Glossary 8-1

9 Index 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

List of figures

Graphic symbols

Page headers and
page footers

Glossary

Index

Sheet of
decontamination
labels

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.

Page VI-1 contains a list of the figures in this manual.

The standard symbols used for bioMérieux instruments, and their meanings,
can be found in the list on page 1-4.

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.

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.

The index is located in chapter 9 at the back of the manual. It is used to locate a
particular description or procedure.

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

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

How to use this manual

Typographic conventions

1

2

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!).

3

4

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

1-4 VIDAS® Instrument User's manual

ON (power supply)

OFF (power supply)

"ON" (only for a component of the system equipment)

How to use this manual

Graphic symbols

"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

1

2

i

LOT

or REF

EC REP

Potential biohazard

Consult Instructions for Use

Batch code

Catalogue number

Temperature limitation

3

4

5

Authorised representative of the European Community

Keep dry

VIDAS

®

Instrument User's manual 1-5

How to use this manual

Graphic symbols

IVD

SN or SN

Manufacturer

Date of manufacture

In Vitro Diagnostic Medical Device

Serial number

Keep away from magnetic field

Separate collection for waste electrical and electronic equipment

1-6 VIDAS

®

Instrument User's manual

2 Functional description

Introduction

This chapter describes the VIDAS instrument:

− its configuration components,

− general features and technical specifications,

− operating principles,

− performance checks / self-tests.

VIDAS

®

Instrument User's manual 2-1

Functional description

Graphic symbols

Analytical module (example)

Computer module (example)

Reagent strip

®

SPR

Fig. 2-1: VIDAS configuration

2-2 VIDAS

®

Instrument User's manual

Description / aim

VIDAS is a compact automated multiparametric immunoanalyzer including:

− the VIDAS analytical module divided into five independent sections each

containing six assays with compatible protocols,

− the VIDAS PC software allowing up to two VIDAS modules to be operated,

− the reagents presented in kits of 60, 30 or 10 unit tests including :

− the SPR

− the additional consumables required: standard, control(s), solvent,

− the factory calibration data provided in the form of a bar code (MLE

− the package insert.

The basic VIDAS workflow steps consist of:

•

creating predefined sections,

•

performing calibrations and controls,

•

running assays.

VIDAS offers routine batch or random access (mixed) testing for:

− serology,

− immunochemistry,

− antigen detection,

− industrial microbiology,

− immunohemostasis.

card),

®

s and reagent strips,

Functional description

Description / aim

1

2

3

VIDAS

VIDAS

The combination of two original concepts, sectioned architecture and single­dose reagents (SPR/Reagent Strip), offers:

− reliable results,

− ease-of-use,

− rapid analyis results.

stands for:

®

Instrument User's manual 2-3

®

Immuno Diagnostic Assay System.

Vitek

The technology used, which is adaptable to a wide range of assays, combines
the EIA method with a final fluorescence reading: this technology is known as
ELFA (Enzyme Linked Fluorescent Assay).

The enzyme used in the VIDAS range is alkaline phosphatase.

The substrate is 4-methyl umbelliferyl phosphate (4-MUP) hydrolyzed into
4-methyl umbelliferone.

Umbelliferone fluoresces at 450 nm after excitation at 370 nm.

4

5

Functional description

(op

Configuration components

Configuration components

Connection to

external systems

(optional)

UPS or laboratory

safety power supply

system (optional)

Printer

First analytical module

Bar code reader

- Monitor

- Computer

- Keyboard

- Mouse

Second analytical
module

tional)

Fig. 2-2: Configuration components (example)

2-4 VIDAS

®

Instrument User's manual

Hardware

Functional description

Configuration components

The VIDAS can be divided into three categories of components :

− hardware,

− software,

− consumables.

VIDAS consists of:

One or 2 analytical modules, each containing 5 sections of 6 positions each
(capacity to process over 200 samples per day).

A computer system offering data management, result storage and bidirectional
interface with the laboratory information system. This system consists of :

− a computer,

− a screen,

− a bar code reader,

− a printer.

1

2

CAUTION!

Software

IMPORTANT! Never download into the computer, programs other than those provided

Consumables

Never use material other than that specified by bioMérieux

The software is multi-task and provides for:

− entry of patient data and assays,

− storage of calibrations in memory,

− display and validation of results,

− system operation and self-tests,

− management of patient records,

− management of the uni- or bidirectional interface (optional).

by bioMérieux. If these instructions are not complied with, the computer
could become infected with computer viruses. Any intervention directly or
indirectly resulting from the presence of such a virus cannot be covered
by the warranty or the maintenance contract.

Assay kit (60, 30 or 10 tests).

®

.

3

4

5

VIDAS

®

Instrument User's manual 2-5

Functional description

Configuration components

Hardware

Analytical module

General remarks

30 tests can be performed simultaneously: 5 sections (A, B, C, D, E) containing
6 positions each.

Each section is microprocessor-controlled and consists of:

− a transport tray for reagent strips,

− a pipetting system,

®

− a SPR

block for pipetting,

− an incubation system.

Each section operates independently, enabling the analytical module to handle
a wide range of tests at one time.

An indicator light on each section shows the current status.

− The indicator light is on when a section is performing an assay.

− The indicator light flashes when the assays are completed.

®

− The indicator light goes off when the reagent strips and SPR

s are

unloaded.

The VIDAS handles reagents via five six-channel pipetting systems (1 system
per section) which carry out all reagent transfers, dilution and washing by means
of the SPRs.

The pipetting system handles liquid volumes of between 8.9 µl to 316.5 µl. The
system is lowered and raised to give the SPRs access to the wells on the
reagent strip.

The six pipetting channels are physically independent but mechanically linked
for synchronized operation.

Movement in each section is driven by stepper motors.

The range of movement is determined by parameter-defined protocols.

The assay temperature is 37°C inside the module.

Each module is equipped with two thermal probes per section, which ensure
that this constant temperature is maintained.

2-6 VIDAS

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Instrument User's manual

Microprocessor

Reagent strip tray

Functional description

Configuration components

In addition to the central processing unit, each VIDAS section contains its own
microprocessor.

Each microprocessor controls the movements required by each assay,
depending on the protocol applying.

Each section is therefore

This unit is responsible for storing and operating assay protocols.

A protocol consists of a series of commands including aspiration of the
reagents, washing and optical scanning.

The microprocessor enables the VIDAS to perform a fully automated assay.

A plastic cover, located at the lower edge of each section, can be lifted up to
reveal the reagent strip tray.

This tray shown in the figure below contains six channels into which reagent
strips can be inserted.

Each channel constitutes a section position.

Up to six single reagent strips or three dual reagent strips can be inserted at one
time, taking the total module capacity to 30 single tests.

independent and autonomous.

1

2

Fig. 2-3: Reagent strip tray

The reagent strip tray is also used for automatic entry of the factory master
calibration data (MLE card) using the card holder.

For further information on the MLE card, see the VIDAS PC User's Manual. Note:

CAUTION! The reagent strip trays are movable parts. The risk of

finger pinching exists.

3

4

5

VIDAS

®

Instrument User's manual 2-7

Functional description

Configuration components

Strip preparation tray

(only concerns
VIDAS blue)

A retractable strip preparation tray is located under each reagent strip tray.

②

Fig. 2-4: Strip preparation tray

closed

Fig. 2-5: Opening the strip

preparation tray

①

Fig. 2-6: Reagent strips placed on

the strip preparation tray

2-8 VIDAS

Fig. 2-7: Reagent strips placed on

the strip preparation tray with their

boat

®

Instrument User's manual

SPR® block

Functional description

Configuration components

The upper part of the section includes a tilt-down door which gives access to
the SPR block .

The six positions of the SPR block correspond to the six positions of the reagent
strip.

During processing, the SPR block and SPRs form a pipetting device that is used
throughout the assay.

The reagent is cycled in and out of each SPR by a piston-driven air system.

1

Fig. 2-8: SPR block

2

3

4

5

VIDAS

®

Instrument User's manual 2-9

Functional description

Configuration components

Incubator

Bar code readers

Detection system

Assays using the VIDAS require a controlled temperature.

The temperature of each section tray and each SPR

®

block is individually

controlled and monitored.

Each tray and SPR block are equipped with a stable high-precision temperature
detection system, known as the thermistor.

During manufacture, each thermistor assembly is tested to NIST (National
Institute of Standards and Technology) ITS-90 tolerance requirements for
temperature measurement.

The thermistors used in the VIDAS are accurate to within 0.2°C.

Only thermistor systems that meet this criterion on manufacture are installed in
the VIDAS.

To display the SPR block and tray temperatures, see the VIDAS PC User's Manual. Note:

Two bar code readers:

− A hand-held

bar code reader is included in the VIDAS configuration. It may

be used to:

− read the bar codes of certain reagents before they are used. The
procedure for using these reagents is described in Chapter 5 of the
VIDAS PC User’s Manual.

− enter patient data or search for patient data (or a specimen) and read
MLE cards.
To install the hand-held bar code reader, see Chapter 4 "Installing the
hand-held bar code reader".

− An internal bar code reader enables identification of the reagent strips and
reading of the MLE card.

The VIDAS detection system consists of an optical fluorimetric scanner.

It is mounted on a mechanical device which enables it to be used on all five
sections.

The system detects any chemical changes occurring in the optical cuvette at the
end of each reagent strip.

Fig. 2-9 shows the position of the optical cuvette on a standard reagent strip.

Optical cuvette

Fig. 2-9: Optical cuvette on a reagent strip

2-10 VIDAS

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Instrument User's manual