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

®

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

®

Instrument User's manual

Central processing
unit

Computer module

UPS

Note:

Extension potential

Functional description

Configuration components

The central processing unit controls all aspects of the VIDAS operations,
including data analysis and verification of optical and mechanical systems.

The computer is designed to operate the analytical module(s) (up to 2) and to
manage assays using the VIDAS PC software (see the VIDAS
Manual).

It

is connected to the module(s) in order to perform automatic analysis of the

various assays.

The computer is equipped with peripherals to display, print and store results.

In the absence of a safety power supply system in the laboratory, the UPS
guarantees an uninterrupted power supply.

It protects the analytical module(s) from any electrical disturbances, ensuring
that test results are systematically preserved.

For further information on peripherals (computer, etc.), see the enclosed manufacturer’s
documentation.

PC User's

1

2

3

VIDAS

− Second analytical module,

− Uni-directional or bidirectional connection (connection to the laboratory

information system).

®

Instrument User's manual 2-11

4

5

Functional description

Configuration components

Consumables

Assay kit

Single reagent strip

Each VIDAS assay kit contains the reagents required to run a specific assay.

Kit contents vary for each assay, but generally a kit contains:

− Single or dual reagent strips,

− SPR®s (Solid Phase):

− one for a single reagent strip,

− two for a dual reagent strip,

− control(s),

− the necessary standard(s),

− a diluent (as required),

− a package insert

− a MLE card.

The VIDAS single reagent strip contains ten wells. The sample is placed in the
first well.

The other eight wells contain the necessary reagents (conjugate, diluent, wash
buffer).

The last well is the optical cuvette in which the fluorescence of the substrate is
measured.

A small tab ensures that the strip is correctly positioned in its channel guides.

Fig. 2-10: Single reagent strip

2-12 VIDAS

Tab

®

Instrument User's manual

Dual reagent strip

Functional description

Configuration components

Some assays require the use of a dual reagent strip, consisting of two strips
side by side.

The sample is divided between the two sample wells on the two reagent strips.

With the strip oriented as shown in the figure below, the upper strip serves as
the reference strip and the lower as the sample test strip.

The sample test strip contains a reagent which is not included in the sample
reference strip.

A comparison of the measurements from the two strips determines the test
result.

1

Fig. 2-11: Dual reagent strip

2

3

4

5

VIDAS

®

Instrument User's manual 2-13

Functional description

Configuration components

Reagent strip label

2

Each VIDAS reagent strip has a label and a color-coded dot. Both are identified
by the same 2-4 character and/or figure code.

The colored dot corresponds to a matching dot on the test’s companion SPR

The bar code identifies:

− the assay name,

− the manufacturing lot number,

− the sequence number,

− the assay kit expiration date.

3

5

6

7

®

.

4

Fig. 2-12: Reagent strip label

TXG

TXG

Fig. 2-13: Reagent strip dot

1

2-14 VIDAS

®

Instrument User's manual

Ref. Description

1: Bar codes

2: Alphanumeric

representation of
the bar code

3: Assay code

4: ID

5: Lot number

6: Expiration date

7: Sequence Number

Under normal operating conditions, the internal bar code reader reads the
machine readable code.

If the system is unable to read this code, the alphanumeric form of the bar code
is used to enter the bar code.

The assay code is based on two or four characters and/or figures which
represent the name of the assay to be performed.

Examples:

− RBG Rubella IgG II

− 153 CA 15-3

All references to an assay in the software and on printed reports use the assay
code.

A blank space is provided to write the sample ID (if necessary) .

The lot number is used by the VIDAS to code the expiration date of the reagent
lot.

This corresponds to the expiration date of the reagent lot. When the bar code
reader reads this date, the VIDAS compares it to the date stored in its memory
to ensure that the lot has not passed its expiration date.

Within a single batch, each reagent tray carries a different number
corresponding to the order of manufacture.

Functional description

Configuration components

1

2

3

4

VIDAS

®

Instrument User's manual 2-15

5

Functional description

Configuration components

SPR®s

Characteristics

Functions

The SPR is a plastic (polypropylene or polystyrene) device capable of capturing
soluble proteins, viruses and bacteria.

®

It is sealed with a color-coded dot and perforated in the center. Each SPR

is

disposable (see Fig. 2-14).

The SPR is the solid phase base for the immunological reaction. Its interior walls
are coated with antibodies or antigens that capture a target analyte.

The SPR is used to pipette samples and reagents, and eliminates cross­contamination between reagent and instrument. Maintenance is reduced to a
minimum since there is no tubing, syringe or sampling needle involved.

Each SPR for a specific assay is identified by a color-coded cap and a letter
and/or figure code representing the assay name.

Fig. 2-14: SPR®

The VIDAS uses the SPR to perform the following operations:

− sampling,

− incubation,

− mixing,

− washing.

2-16 VIDAS

®

Instrument User's manual

Functional description

General features and technical specifications

General features and technical specifications

Environmental conditions

Operating temperature: + 15° C to + 30° C (59° F to 86° F)

Storage temperature: + 10° C to + 40° C (50° F to 104° F)

Relative humidity: 10 to 80%, without condensation

1

Type of installation:

Installation category (voltage overload
category):

Degree of pollution:

Maximum installation altitude: 2 000 m

for indoor use only; light industrial
equipment

2

II (according to standard IEC 61010.1)

no. 2 (according to standard IEC

61010.1)

3

4

VIDAS

®

Instrument User's manual 2-17

5

Functional description

General features and technical specifications

Physical features

Dimensions

VIDAS blue VIDAS

Instrument packed Instrument alone Instrument packed Instrument alone

Height

Width

Depth

59 cm (23¼") 45 cm (17⅝") 58.2 cm (23")

110 cm (43⅓") 88 cm (34½") 99 cm (39")

66 cm (26")

55 cm (21⅝

")

67.5 cm (26⅝ ")

44.4 cm (max.)
(17½")

84.7cm (33⅓")

52.4 cm (20⅝")

Space requirements

Height

Width

Depth

VIDAS blue VIDAS

65 cm (25⅝") 65 cm (25⅝")

150 cm (59") 150 cm (59")

90 cm (35½") 90 cm (35½")

The instrument must be placed on a flat surface with a maximum horizontality
defect of 5°.

Weight

VIDAS blue VIDAS

Instrument packed Instrument alone Instrument packed Instrument alone

Mass

75 kg (165⅓ lbs) 65 kg (143⅓ lbs) 71 kg (156½ lbs) 61 kg (134½ lbs)

Sound level

Sound level: <

59 dBA

2-18 VIDAS

®

Instrument User's manual

Electrical specifications

Class I equipment

Voltage

Consumption

Frequency

Safety fuse

Approximate emission of
heat

Power switch

Internal code bar reader

Functional description

General features and technical specifications

VIDAS blue VIDAS

100 – 240 VAC

3 - 1.2 A

280 VA 200 VA

50-60 Hz 50 – 60 Hz

External :

4.0 AT

921 Btu/hr
270 W

Location :
Back of the module

Type :
bipolar (live + neutral)

Maximum leakage current:
< 1 mA

The instrument includes an internal bar code reader with a 660 nm LED
whose radiation is Class 1 according to IEC 60825-1. This class does not
present a risk.

Nota : The voltage (100 - 120 VAC

External (power input module)

3.0 AT at 100 - 120 VAC

1.6 AT at 200 - 240 VAC

512 Btu / hr (rated)
150 W

100 - 120 VAC

200 - 240 VAC

or 200 - 240 VAC) is
selected using the power
supply unit at the rear of the
module.

1

2

3

4

5

VIDAS

®

Instrument User's manual 2-19

Functional description

General features and technical specifications

Technical specifications

Processing capacity

− 30 test positions:
5 sections each containing 6 positions.

− Up to 50 tests/hour depending on the type of test used (see test duration
indicated on each VIDAS assay package insert).

Motors

Pumping

− Automatic control by means of stepper motors.

− 5 pumps: one per section.

− Mixing, dilution and transfer of reagents.

Temperature control

Absolute precision

®

SPR

blocks: 37 ± 1°C

Section tray: 37°C (-2°C, + 1°C)

Relative precision

SPR blocks: ± 0.7°C (against the average of all the SPR blocks)

Section tray: ± 1°C (against the average of all the section trays)

Process

Automatic control

Thermal resistance

By thermal probes

2-20 VIDAS

®

Instrument User's manual

Characteristics of optical components

Functional description

General features and technical specifications

Detector

Detection range

Automatic self-testing

Assay kit

SPR®

Reagent strip

Fluorimetric photodiode

40 to 40000 nmol of 4MU (4-Methyl Umbelliferone)

Automatic self-testing of the optical system every 12 hours against a benchmark
standard (known as the "Solid Standard").

Automatic recalibration if the deviation from the Solid Standard is ≥ 0.6 %.

Length: 76 mm (3 inches)

Composition: plastic polymer

Work volume: 5 - 350 µl

External dimensions

VIDAS assay

Length

157 mm (6.2 inches)

1

2

3

VIDAS

Width

Depth

Well capacity

Sample well: 960 µl

Reagent well (8): 960 µl

Substrate well: 530 µl

The strip is covered by foil which seals the wells and prevents any evaporation
that might compromise the reagents.

The substrate well is made of a plastic which has the appropriate optical
qualities.

®

Instrument User's manual 2-21

18 mm (0.7 inches)

15 mm (0.6 inches)

4

5

Functional description

Operating principles

Operating principles

Immunoassay methods

INDIRECT EIA

ANTIBODY TO BE

DETECTED

BOUND
ANTIGEN

4-METHYL

UMBELLIFERYL

PHOSPHATE

ALKALINE PHOSPHATASE
LABELED ANTIBODY

Detection of antibody

The antigen is coated on the interior walls of the SPR®.

If the sample contains the antibody to be detected, the 4-methyl
umbelliferyl phosphate is hydrolyzed to umbelliferone.

IMMUNOCAPTURE

ANTIBODY TO BE

DETECTED

ALKALINE PHOSPHATASE
LABELED ANTIBODY

ANTIGEN IN LIQUID

MEDIUM

UMBELLIFERYL

PHOSPHATE

4-METHYL

Detection of immunoglobulins M

The IgM to be detected is captured by the anti-IgM coated on the
interior walls of the SPR.

The presence of the IgM is detected by the Ag stabilized in liquid
medium.

Detection of antigens (bacterial, viral, protein, ...)

ALKALINE PHOSPHATASE

LABELED ANTIBODY

The interior wall of the SPR is coated with antibody.

In the above three methods, the fluorescence levels measured are
directly proportional to the quantity of antibody or antigen present in
the sample.

Detection of haptens (hormones, ...)

The interior wall of the SPR is coated with a limited quantity of
antibody.

COMPETITION

BOUND

ANTIBODY

BOUND
ANTIBODY

ANTIGEN TO BE
DETECTED

4-METHYL

UMBELLIFERYL

PHOSPHATE

4-METHYL

UMBELLIFERYL

PHOSPHATE

The hapten to be detected competes with the labeled hapten.

ALKALINE PHOSPHATASE
MARKED HAPTEN

The fluorescence level measured is inversely proportional to the
quantity of haptens present in the sample.

HAPTEN TO BE DETECTED

2-22 VIDAS

®

Instrument User's manual

Protocol concept

Definition

Method

Functional description

Operating principles

A protocol defines a specific sequence of operations required to perform an
assay. It therefore covers :

− sample volume,

®

− incubation time in the SPR

− frequency of cycling of reagents in and out of the SPR,

− movements of the SPR and the reagent strip,

− final reading.

Assays using the same protocol can be carried out in the same section.

The VIDAS will automatically group compatible assays.

The sample (serum or pre-treated) must be placed in the sample well on the
reagent strip as indicated in the appropriate assay package insert.

The sample volume required varies according to the test and is given in the
assay package insert.

The reagent strip slides horizontally to position the required well under the SPR.

The SPR moves up and down so it can perforate the foil seal and pipette the
required reagents.

Dynamic reactions:

At each stage, the reagent is cycled in and out of the SPR several times. This
increases reaction kinetics and reduces incubation times.

,

1

2

3

4

VIDAS

Fig. 2-15: Dynamic reactions

®

Instrument User's manual 2-23

5

Functional description

Operating principles

Different stages of the protocol

Reagent check

Wash buffer

Strip

Sample Diluent

SPR

Conjugate

Wash buffer

Substrate

Wash buffer

Fig. 2-16: Example of a protocol

Before starting the assay, the system checks the reagent; it scans the bar code,
reads substrate fluorescence and checks the expiration date of the strips.

Any anomaly is reported on the screen.

Bar code scanning error (ERRCB)

This error report will be generated if the reagent strip does not correspond to the
assay requested, if the corresponding protocol is not activated, if the strip is not
properly inserted or if the scanner has difficulty reading the bar code. If the
scanner has difficulty reading the bar code, it can be entered manually.

This error report will also be generated if you have inserted more strips than
expected.

Whatever the cause, refer to the VIDAS PC User's Manual.

Substrate fluorescence error (ERRSUB)

The software contains standard fluorescence levels designed to guarantee
reagent quality.

If levels measured do not fall within the standard range, a warning appears on
the screen and the fluorescent value of the substrate can be displayed in the
Error Reporting Menu.

Kit not calibrated or expired calibration (ERRCAL).

Expired lot (ERRLOT)

• Rerun the assay with a valid lot.

2-24 VIDAS

®

Instrument User's manual

Immunological reaction

Determining background

Chemical reaction

Fluorescent reading

Functional description

Operating principles

The SPR®, coated with antigen or antibody, is brought into contact with the
sample, the conjugated antibody and the substrate.

SPR washing operations are also programmed.

At this stage, the VIDAS makes a fluorescent reading of the substrate. This
fluorescence value will appear on the result sheet under the heading BKG
(background).

The 4-methyl umbelliferyl phosphate is hydrolized to 4-methyl umbelliferone by
the alkaline phosphatase in the SPR.

The intensity of the final reaction is measured in the optical cuvette on the
reagent strip.

1

2

Optical system

450 nm

370 nm

Photodiode

Fig. 2-17: Fluorescent reading

The VIDAS optical system measures the concentration of reagent developed
during the assay, using a single channel fluorometer.

This optical system uses dual beam excitation to compensate for variations in
the lamp output.

The optical system can be moved through the module to read the required test.
The reagent then produces a fluorescent signal proportional to its concentration.

3

4

5

VIDAS

®

Instrument User's manual 2-25

Functional description

Performance checks / self-tests

Performance checks / self-tests

Optical system

Calibration principle

The module’s optical system is controlled and calibrated by a bioMérieux
technician during maintenance operations. To do so, the bioMérieux technician
uses a standardized solution of 4-MU in a buffer (see Manual Calibration).

Once the module is correctly calibrated, it measures the fluorescence of the
solid standard and then stores this value in the VIDAS system's permanent
memory.

This value then becomes the reference point for all future calibration checks.

Optical system self-tests

The VIDAS carries out periodic readings in air and on the solid standard and
sends an error message if these readings fall out of expected bounds.

®

Manual calibration

The instrument is calibrated against a standard solution contained in VIDAS
strips of the same design as reagent strips.

Specific fluorescence values are assigned to these calibration strips.

This corresponds approximately to a reading of 3200 RFU with a solution of
4-methyl umbelliferone (4-MU) of 8000 nmol in a buffer.

Manual calibration of the module is performed by a bioMérieux

technician during

maintenance operations.

2-26 VIDAS

®

Instrument User's manual

Autocalibration

Functional description

Performance checks / self-tests

The VIDAS optical system has proven to be highly reliable and stable over
many years of use.

As a further step in checking system performance, the VIDAS also uses a
reference to compensate for any drift in the optical system.

The VIDAS module therefore incorporates a specific material (fluorescent
europium) embedded in an optically clear polymer, to serve as an optical
reference (also known as the solid standard).

This reference enables the VIDAS to check the entire optical system and
correct the variations likely to cause the level of fluorescence to drift.

The long-life reference material is placed in a well inside the module, between
sections A and B. The optical system periodically measures the reference and
the results are monitored by the VIDAS to ensure that optical drift is minimal.

Every 12 hours, the VIDAS carries out a calibration check, consisting of three
readings of the solid standard. It averages out the results and compares the
average against the value in memory.

The VIDAS automatically recalibrates if it finds a difference greater than 0.6 %
(a variation of 19 RFU for a value of 3200 RFU) from the value in memory.

The recalibration is carried out automatically by three new readings. The new
average value calculated must this time be less than 0.4% (13 RFU for a value
of 3200 RFU) of the value in memory.

The series of readings continues until this level of 0.4% is reached by
successive recalibrations.

If the value of the optical calibration changes by more than 3% (96 RFU for a
value of 3200 RFU), an error message which does not block the system
(ERROR 160 see chapter 12 "Troubleshooting" in the VIDAS PC User’s
Manual) will inform you. Unless this error occurs while your instrument is
warming up (see chapter 3 "Getting started" in the VIDAS P
call your bioMérieux
checked before a problem arises.

If the system is reaching the end of its recalibration capacity, ERROR 161 is
generated (see chapter 12 "Troubleshooting" in the VIDAS PC User’s Manual).
Call your bioMérieux Technical Assistance Dept. immediately.

®

Technical Assistance so that the instrument can be

C User’s Manual),

1

2

3

4

VIDAS

®

Instrument User's manual 2-27

5

Functional description

Performance checks / self-tests

Pipette mechanisms

Calibration and self-tests

On-site calibration of the pipette mechanisms is not necessary.

Controls of pipette mechanism precision during manufacturing include physical
inspection, pressure and volume checks on each module and a liquid transfer
check carried out on the fully assembled equipment before shipment.

When an assay is performed, the VIDAS checks the movement of the pipette
mechanisms. If there is any variation from the expected movement, the assay is
automatically halted and the computer sends an error message.

Field checks of the pipettor accuracy may be accomplished by using
bioMérieux

®

controls.

VIDAS

temperature

Self-tests

The SPR®/strip environment is maintained at a controlled temperature. Each
SPR block includes a heating element and a temperature sensor. The same
principle is applied to the reagent strip section trays.

The temperature of each section is individually regulated. An error message is
generated if the temperature moves out of the required range.

The sensor sends the measured value to the section microprocessor which
responds by regulating the heating element accordingly.

SPRs are kept at a constant temperature of 37°C ± 1°C which must not vary by
± 0.7°C from the average for the five compartments.

On the same principle, the reagent strip section trays are maintained at 37°C
(-2°C, + 1°C) with a maximum variation of ± 1°C from the average for the five
sections.

If a temperature error occurs, the VIDAS halts all assays in progress. No further
assays can be launched in this section until the temperature returns to its
normal operating range.

2-28 VIDAS

®

Instrument User's manual

3 Getting started

Introduction

This chapter gives recommendations for installation and use of the VIDAS
instrument.

CAUTION! You are advised to read this chapter in full and follow the different

instructions in order to use the VIDAS correctly.

VIDAS

®

Instrument User's manual 3-1

Getting started

Recommendations for installation and use

Recommendations for installation and use

In order to facilitate assembly, it is recommended that the components are
unpacked and the instructions below are carefully read before starting.

CAUTION! The VIDAS weighs 65 kg (143 ⅓ lbs). Two people should lift it out of its

box and place it on the benchtop.

The instrument must be placed on a flat surface with a maximum
horizontality defect of 5°.

The VIDAS blue should be lifted or moved using the gripping area located
on its base.

Before unpacking the instruments, it is advisable to have previously
planned where they will be placed.

Avoid exposing the equipment to direct sunlight, excessive heat, humidity
or dust.

Only power cords and accessories supplied by bioMérieux® SA should be
used to connect the instruments.

Nothing should be placed on top of the connection cables, whether
temporarily, permanently or intermittently. Cables should not be laid
across passage-ways.

Computer cables must not intersect or be placed too close to one another.

Cables should not be allowed to form loops or knots, or be rolled up near
or on other electrical equipment.

All connections should be performed with the power OFF.

Before connecting the system to the power supply, check that all switches
are in the OFF position.

The electrical supply to which the system is connected must conform to
current standards:

diameter of cables,

−

−

grounding,

−

protection through circuit breaker and/or use of fuse,

−

connector calibration and type...etc.

3-2 VIDAS

®

Instrument User's manual

Getting started

Recommendations for installation and use

CAUTION!

The electrical power supply must be:

−

direct,

−

individual,

−

calibrated,

−

protected,

−

compatible with the technical specifications of the product or
configuration.

No other electrical equipment likely to interfere with the proper functioning
of the system should be connected on the same circuit.

Extension sockets and serially connected adapters should not be used.

If the power supply is not sufficient to guarantee proper functioning of the
product, an independent protective device, adapted to the product’s
technical characteristics should be used.

Do not use power sockets controlled by wall-mounted switches or timers.
Accidental power cuts may destroy information in both the analytical
module and the computer memories.

No electrical equipment likely to cause interference (equipment not
bearing the CE mark...) should be operated in the immediate vicinity of the
system.

The safety connection (ground) should not be interrupted by an extension
cord without a protection (ground) conductor.

Before connecting or disconnecting the connecting cables, check that the
power supply cords of the CPU and all the units connected to it are
themselves disconnected.

When adding units to the system or removing them, disconnect the power
cables to these units before connecting or disconnecting the connecting
cables.

Never connect the VIDAS to the same power supply as devices which
generate high current surges (centrifuges) or which, due to frequent start­ups, generate interferences if they are ill-protected (freezers, water
baths...).

1

2

3

4

VIDAS

®

Instrument User's manual 3-3

5

Getting started

Unpacking the VIDAS

Unpacking the VIDAS

Before opening the boxes, make sure that no damage has been caused during
transport.

If damage has occurred, make a claim to the transport company and notify
bioMérieux

When opening the boxes, make sure that all the items in the packing list have
been delivered.

If possible, keep packaging materials in case the VIDAS instrument has to be
moved in the future

CAUTION! Any damage directly or indirectly resulting from the transport of the

instrument without adequate containers will not be covered by the
warranty or maintenance contract.

The VIDAS weighs 65 kg (143 ⅓ lbs). Two people should lift it out of its
box and place it on the benchtop.

The instrument must be placed on a flat surface with a maximum
horizontality defect of 5°.

®

.

.

The VIDAS blue should be lifted or moved using the gripping area located
on its base.

Fig. 3-1: Gripping area (only concerns VIDAS

blue)

3-4 VIDAS

®

Instrument User's manual

Assembly and installation

This manual contains information and warnings which have to be respected by
the purchaser or the lessee to ensure safe operation and to maintain the
instrument in good condition.

Getting started

Assembly and installation

1

CAUTION! The system must be installed and brought into service by or under the

guidance of bioMérieux

After installation, users are given training to help them make the most of
their VIDAS system in the shortest possible time.

bioMérieux Technical Assistance must be contacted before moving the
equipment, failing which, any such action is taken entirely under the
user’s responsibility.

Never download into the computer, programs other than those provided
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.

The computer media (floppy disks or CD ROMs) containing the VIDAS
software programs or the user’s backups used for installation or
reinstallation must be stored in an appropriate location.

The different elements composing your VIDAS: hardware, software
programs, software configuration (especially date and time format,
language, type of keyboard, …) are part of a configuration validated by
bioMérieux
configuration to the one validated may cause incorrect operation.

SA. Any modification or addition resulting in a different

®

Technical Assistance.

2

3

4

VIDAS

®

Instrument User's manual 3-5

5

Getting started

Assembly and installation

DANGER ! Any break in the grounding protective conductor inside or outside the

equipment or disconnection of the protective ground terminal may
render the equipment dangerous. Deliberate interruption of such
conductors is forbidden.

Opening the covers or removing components, except those maneuvrable

by hand, may give access to parts that can be dangerous if touched.

Disconnect the instruments prior to any adjustment, replacement,

servicing or repair requiring them to be opened.

After opening, if it is imperative to switch the instrument on, any

adjustment, servicing or repair should be performed by a qualified
technician, well aware of the possible risks.

During a storm, never connect cables to the keyboards/screens, printer

or telephones, or lightning conductors to the transmission lines.

Choosing a location

CAUTION! Avoid exposing the equipment to direct sunlight, excessive heat, humidity

or dust.

To ensure that the temperature control maintains the temperature at 37°C,
the system must be set up in a room with an ambient temperature of
between 15°C and 30°C.

Leave sufficient clearance around the analytical module for the circulation
of air, essential to proper temperature control, and for easy access to the
power switch.

Do not install the UPS near the right-hand side of your analytical module.

3-6 VIDAS

®

Instrument User's manual

4 Starting the VIDAS

Introduction

This chapter describes:

− the procedure for switching on the VIDAS instrument,

− the procedure for installing the hand-held bar code reader.

VIDAS

®

Instrument User's manual 4-1

Starting the VIDAS

Switching on

Switching on

Step 1

Step 2

After you have assembled and installed the various VIDAS components,
ensuring that the safety instructions set out in Chapter 3 "Getting started", have
been correctly followed, proceed as follows:

•

Switch on the UPS, if required.

•

Switch on the analytical module and leave it to warm up for 45 minutes.

Step 3

Step 4

Step 5

Step 6

CAUTION!

The power switch is located on the back of the analytical module. It must
be easy to reach at all times.

Power switch

Fig. 4-1: Power switch

•

Switch on the printer and screen.

•

Switch on the computer.

Refer to the section entitled "Starting VIDAS PC" in Chapter 3 of the VIDAS PC
User's Manual.

•

Turn the power switch on the analytical module to the "OFF" position.

•

Wait for 1 minute and turn the power switch to the "ON" position.

The

VIDAS proceeds to self-test its mechanical and optical systems.

All these operations take about ten minutes, during which time the VIDAS
cannot be used to run assays.

The VIDAS can only be used once the self-test phase is completed. The user is
alerted by the appearance of the message "AVAIL" on the section status.

4-2 VIDAS

®

Instrument User's manual

Installing the hand-held bar code reader

Installing the hand-held bar code reader

Preliminary instructions

IMPORTANT! You are advised to read this procedure in full and follow the different

instructions in order to use the bar code reader correctly.

Each VIDAS configuration in your laboratory should be equipped with a
hand-held bar code reader. Repeat this procedure for each computer
dedicated to your VIDAS configuration.

Perform this procedure BEFORE using new VIDAS reagent kits.

Note:

This procedure does not involve the analytical module. It only applies to the VIDAS PC
software host computer.

Starting the VIDAS

1

2

3

4

5

VIDAS

®

Instrument User's manual 4-3

Starting the VIDAS

Installing the hand-held bar code reader

Preparing the computer

The computer should be switched on.

Checking the keyboard language

Check the VIDAS PC computer keyboard language before configuring the bar
code reader. To do this,

On the Windows

1. click on the button in the bottom left-hand corner of the screen

(or press one of the "Windows" keys situated either side of the space bar).

2. Select "Settings", "Control Panel" and "Regional and Language Options".

2

®

desktop:

1

Fig. 4-2 : Configuration options

4-4 VIDAS

®

Instrument User's manual

Starting the VIDAS

Installing the hand-held bar code reader

The options screen is displayed.

3. Select the "Languages" tab.

4. Click "Details...".

The "Text Services and Input Languages" window is displayed.

5. Select the "Settings" tab .

1

6. The default language is indicated:

• Note down this information which will be required for configuration of the

reader.

1

2

Fig. 4-3 : Configuration details

•

Click to close the different option windows and return to the Windows®
desktop.

3

4

2

3

4

5

VIDAS

®

Instrument User's manual 4-5

Starting the VIDAS

Installing the hand-held bar code reader

Switching off the computer

The VIDAS PC host computer should be switched off. To do this,

•

Make sure that:

− no assays are running,

− no reagents (strips and SPR

blocks,

− printing is not in progress.

To quit the VIDAS PC software:

•

click on the stop icon in the top right-hand corner of your work window.

The following dialog box displays.

®

s) remain in the strip sections and SPR

®

•

Click on "Yes".

®

The Windows

desktop displays.

To quit the BCI RS232 or BCI-NET software (if necessary),

•

click on the stop icon in the top right-hand corner of the BCI window.

• Follow the instructions in the dialog box corresponding to the BCI software

installed on your computer.

®

The Windows

4-6 VIDAS

desktop displays.

®

Instrument User's manual

Starting the VIDAS

Installing the hand-held bar code reader

To shut down the computer:

Click on the button in the bottom left-hand corner of the screen or

•

press one of the "Windows" keys situated either side of the space bar,

• Select "Shut Down…".

1

The following window appears.

Fig. 4-4 : Shutting down Windows®

2

3

4

1

2

Fig. 4-5 : Shutting down the computer

5

VIDAS

1. Select "Shut down".

2. Click "OK".

The computer will stop and shut down.

For further information, refer to the VIDAS PC User’s Manual.

®

Instrument User's manual 4-7

Starting the VIDAS

Installing the hand-held bar code reader

Preparing the reader

The reader is supplied in a kit containing:

− 1 bar code reader (1),

− 1 cord (2),

1

2

− 1 configuration sheet.

•

Connect (2) to (1).

The bar code reader can now be connected to the computer.

Note:

The kit must include the above mentioned components. If any are missing,
call bioMérieux® Technical Assistance or your local bioMérieux
representative.

Connecting the bar code reader

Note: The bar code reader preparation procedure must have been previously performed.

There are two possibilities:

− The system is already equipped with a reader
described below.

− The system is not equipped with a reader

Step 1

Disconnect the reader:

− If the cord connecting the reader to the computer is Y-shaped:

: perform all the steps

: proceed directly to step 2.

• Disconnect the Y-shaped cord from the keyboard port on the computer (1)

and from the keyboard cord (2) (see diagram below).

1

2

•

Reconnect the keyboard cord to the keyboard port (1)).

•

Proceed to step 2.

− If the cord is directly connected to the computer:

•

Disconnect the reader cord from the connection port (USB port)

•

Proceed to step 2.

4-8 VIDAS

®

Instrument User's manual

Step 2

Starting the VIDAS

Installing the hand-held bar code reader

Connecting the bar code reader:

The bar code reader cord must always be connected to a USB port. This port
may be located at the back and/or at the front of the computer depending on the
VIDAS configuration.

Step 3

It is flat and is identified by the symbol

.

• Connect the reader cord to a USB port (the figure below shows the

connection at the back of the computer).

Note: For systems which were already equipped with a reader, use the USB port to

which the old reader was connected.

•

Switch the computer back on.

The reader initializes and emits 2 beeps.

•

Wait for the Windows® login screen to display.

•

Enter your user name and password.

Note: If the VIDAS is switched off, follow the instructions in section "Switching on,

page 4-2.

If the VIDAS system was already equipped with a reader, the old reader’s
configurations will be replaced by the
reader.

default configuration of the new bar code

1

2

3

4

VIDAS

®

Instrument User's manual 4-9

5

Starting the VIDAS

Installing the hand-held bar code reader

Configuring the bar code reader

IMPORTANT! The reader you have received has already been configured by bioMérieux

and takes into account most of the existing types of bar codes.
Should the reader lose its configuration, refer to the following procedure.

Before configuring the bar code reader, check that:

− the reader has been assembled and connected,

− the computer is switched on and a session is open (the Windows

displayed).

− the configuration sheet included in the bar code reader kit is available,

− the information concerning the keyboard language (checked during the

"Checking the keyboard language" step) is available.

IMPORTANT! Before configuring the bar code reader, check that the upper case key

(<Maj> or <Caps lock>) is disabled.

• Follow the instructions on the configuration sheet.

®

desktop is

Fig. 4-6 : Example of a reader configuration sheet

At the end of configuration, the reader is ready for use.

4-10 VIDAS

®

Instrument User's manual

Recommendation for use of the bar code reader

To read a bar code:

•

Hold the reader about 5 cm from the bar code.

•

Check that the reader is perpendicular to the bar code (maximum 5° tilt).

•

Depress the trigger.

A red beam of light will appear on the bar code.

•

Hold the trigger and slowly scan the bar code from top to bottom or bottom
to top until the code has been read completely.

A beep and a green LED indicate that reading has been performed correctly.

Starting the VIDAS

Installing the hand-held bar code reader

1

Nota : If pdf bar codes are read, refer to the VIDAS PC User’s Manual, Chapter "Updating a

VIDAS assay".

When reading is complete:

•

Release the trigger.

If reading does not occur immediately:

•

Slowly move the reader away from and/or towards the bar code until the
optimal position for reading has been reached.

•

If the problem persists, refer to Chapter 7 "Troubleshooting".

2

3

4

VIDAS

®

Instrument User's manual 4-11

5

5 Using VIDAS

Introduction

This chapter contains the procedure to be followed to carry out routine
operations on the VIDAS.

Before applying these procedures, you will have already:

− switched on VIDAS.

− defined the system configuration options explained in the VIDAS

Manual.

®

PC User's

VIDAS

®

Instrument User's manual 5-1

Using VIDAS

Basic VIDAS work flow

Basic VIDAS work flow

Step 1
Prepare the sample.

Step 5
Place the reagent strips in their
positions and fill them.

Step 6
Close the door of the SPR

®

block.

Step 2
Create a predefined section
and then reserve a section.

Step 4
Place the SPR

Step 7
Lower the section's cover.

®

s in their slots.

Step 3
Fill the sample well.

(Basic VIDAS work flow continued on next page)

Fig. 5-1: Basic VIDAS work flow

5-2 VIDAS

®

Instrument User's manual

Using VIDAS

Basic VIDAS work flow

Step 8
Run assays.

Step 9
Results are printed (depending on the software
configuration).

For details of routine use of your VIDAS, refer to the VIDAS PC User's Manual. Note:

The following procedure outlines the common work flow steps that are used for
VIDAS immunoassay tests.

Sample preparation steps, which may vary from one assay to another, are
described in the package insert of each assay.

The VIDAS blue strip preparation tray can be used to bring the reagents to
room temperature (see Fig. 2-6 and 2-7, on page 2-8).

CAUTION! Never dispense samples into the reagent strips when

Fig. 5-2: Basic VIDAS work flow (cont'd)

they are on the strip preparation tray.

The strip preparation tray should only be used for reagent
strips. Do not place samples on it.

Step 10
When assays are completed, remove the reagent
strips and SPRs.

2

3

4

Step 1

Step 2

VIDAS

IMPORTANT! Always observe good laboratory practices and universal safety

precautions when handling VIDAS assays.

If the test is being used for the first time, its data must be updated in the
VIDAS PC software. Follow the instructions in Chapter 5 "Updating a
VIDAS assay" of the VIDAS PC User’s Manual.

•

Prepare samples as described in the appropriate assay package insert.

•

Create a predefined section, reserve a section and generate a loading
report (see VIDAS PC User's Manual).

®

Instrument User's manual 5-3

5

Using VIDAS

Basic VIDAS work flow

Step 3

To fill a reagent strip,

•

Place the prepared samples, standards and controls in the appropriate
wells on the reagent strip.

The sample is placed in the sample well as indicated shown in the package
insert.

The assay package insert specifies the volume of sample required to ensure
proper performance of the assay.

Step 4 To load a SPR

•

Open the SPR block door.

•

Place the SPR in the SPR block position directly above the corresponding
reagent strip.

®

,

CAUTION!

When placing the SPR in the SPR block position, do not apply pressure to
the block position as this may cause the SPR to be ejected.

IMPORTANT! Check the position of SPRs and reagent strips. The SPR color-coded dot

must match the dot on the corresponding reagent strip.

CAUTION!

It is very important that all the correct SPRs are properly placed in the SPR
block and the dot on top has a hole. The VIDAS cannot detect the type of
SPR used nor the absence or presence of SPRs.

Step 5 To load a reagent strip,

•

Lift the cover of the reagent strip section.

•

Holding it by its handle, insert a reagent strip into its assigned test position.

•

Slide the strip into the position until it seats fully in the channel. The strip
should now be firmly fixed in the channel.

CAUTION!

Strips and SPRs should not be loaded in advance but just before the
corresponding test is performed, since preincubation in the sections may
affect results. However, certain tests do require preincubation, in which
case the strips can be incubated in the VIDAS (refer to the corresponding
reagent package insert).

IMPORTANT! It is very important to respect the required volume indicated in the assay

package insert.

It is important not to have solids in the sample that could clog the tip of
the SPR.

Do not use the strips if the aluminium foil is damaged or if reagents are
leaking, as this could affect the accuracy of test results.

Always make sure you put the correct patient sample into the assigned
strip.

For optimum operation of the instrument, the SPR
must be kept closed.

5-4 VIDAS

®

block and tray doors

®

Instrument User's manual

Using VIDAS

Basic VIDAS work flow

Step 6

Step 7

Step 8

Step 9

Step 10 When the assays are completed:

Step 11

CAUTION!

•

Close the SPR® block door(s).

•

Lower the cover(s) of the reagent strip section(s).

Run the assays.

•

Section status switches from
having checked the reagent, VIDAS indicates the time of completion.

− A report is automatically printed (depending on the software configuration).

− Section status switches from

.

− The section door indicator light flashes to indicate that the reagent strips and
SPRs should be removed.

•

Remove the completed reagent strips from each section used.

•

Remove the used SPRs, making sure that each carries a color-coded dot.

If a SPR does not have its color-coded dot:

−

Reject the result corresponding to the defective SPR.

−

Check that the dot has not become stuck on the SPR block or the
SPR

seal and if it has, then remove it.

−

Repeat the assay corresponding to the defective SPR.

−

Inform bioMérieux® Technical Assistance.

When a SPR block door is closed after SPRs are removed,

to and then . After

(time of completion of the assay) to

2

3

4

VIDAS

− section status switches from

− the section indicator light stops flashing, indicating that the section is free to

perform a new assay.

®

Instrument User's manual 5-5

to

.

5

6 Maintenance

Introduction

This chapter deals with:

− the routine maintenance operations which should be performed by the user.

− the preventive maintenance operations performed by bioMérieux

technicians or a qualified person trained by bioMérieux.

®

VIDAS

®

Instrument User's manual 6-1

Maintenance

Preventive maintenance

Preventive maintenance

Optimum performance of the VIDAS (within the limits of manufacturer
specifications) depends on the preventive maintenance being performed by
bioMérieux
part of a maintenance contract.

The list of maintenance operations and their frequency is available from
bioMérieux.

IMPORTANT! As well as the user maintenance operations described in this manual,

periodic preventive maintenance must be performed by bioMérieux.

®

technicians or a qualified person trained by bioMérieux only, as

6-2 VIDAS

®

Instrument User's manual

User maintenance

Maintenance

User maintenance

DANGER ! Opening covers or removing components other than those

WARNING! After opening, if it is imperative to switch the instrument on, any

Tools required

maneuverable by hand may give access to parts of the equipment that
can be dangerous to touch; exposed terminals may also be dangerous to
touch.
Prior to any adjustment, replacement, servicing or repair, disconnect the
instrument if it has to be opened.

adjustment, servicing or repair should be performed by a qualified,
properly trained technician, well aware of the possible risks and
appropriate service procedures.

No specific tools are required for preventive maintenance of VIDAS.

The basic equipment and products required are:

− sponges (Part no. 99 087),

− a flat screw-driver (VIDAS),

− a screwdriver for recessed head screws (only concerns VIDAS blue),

− disposable powderless gloves (latex-type),

®

− Dacron

− demineralized water,

− bleach solutions containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium

hypochlorite); these solutions should be prepared in demineralized water,

− curved forceps,

− normal laboratory detergent solutions (7X

equivalent) used according to the manufacturers recommendations.

swabs (Part no. 30 531),

®

, Alconox®, Liquinox® or

6

7

8

9

10

VIDAS

®

Instrument User's manual 6-3

Maintenance

Summary of maintenance operations

Summary of maintenance operations

Frequency

Equipment

VIDAS blue

Weekly

(S)

• •

®

block Decontaminate:

Monthly

(M)

As required

(B)

• Clean SPR

Decontaminate:

analytical module

− strip tray

− strip preparation

tray,

− spill tray.

•

Test the pipette
mechanisms using
the bioMérieux

®

SA

− strip tray,

− strip preparation

tray,

− spill tray.

(in the event of
accidental
contamination).

control reagent.

VIDAS analytical

• •

• Clean SPR block . Decontaminate:

Decontaminate:

module

− strip tray,

− spill tray.

•

Test the pipette
mechanisms using
the bioMérieux SA

− strip tray,

− spill tray.

(in the event of
accidental
contamination).

control reagent.

Computer

Printer

• • •

Clean

• Clean : screen

(1)

. Replace ink

cartridge.

Bar code reader

• •

(1)

For cleaning of the computer and printer, refer to Computer on page 6-20 and Printer on page 6-22.

Note: To check the pipette mechanisms, follow the instructions in the reagent package insert. To

analyze the results, you must refer to the printed report and the package insert.

Clean the window.

(1)

.

WARNING! All the panels of the instrument should be regularly cleaned with a mild

detergent diluted in water.

Do not use hot water (maximum temperature: 60°C) to clean the
instrument bodywork and removable parts (e.g. plastic trays, strip
preparation tray).

6-4 VIDAS

®

Instrument User's manual

Decontamination of the VIDAS blue

Decontamination of the VIDAS blue

Decontamination involves:

DANGER ! Turn the VIDAS power switch to "OFF" and then disconnect the power

− Routine decontamination which should be performed on a periodic basis.

− Cleaning of accidental spills (accidental contamination), which should be

dealt with immediately.

cord.
Use POWDERLESS disposable gloves.
This operation must be performed once all assays are completed.
Do not allow disinfectant solution to spill into the instrument.

Maintenance

6

7

8

9

10

VIDAS

®

Instrument User's manual 6-5

Maintenance

Decontamination of the VIDAS blue

Cleaning the SPR® block

(weekly)

DANGER ! This operation must be performed once all assays are completed. Use

POWDERLESS disposable gloves.

Do not allow disinfectant solution to spill into the instrument.

To clean the SPR block the section needs to be fully open.
To do this:

•

•

Open the section door slightly.

Pull the safety latch towards you and then fully open the section door.

Fig. 6-1: Opening the section fully

6-6 VIDAS

®

Instrument User's manual

Maintenance

Decontamination of the VIDAS blue

Fig. 6-2: Cleaning the SPR® block

Using a Dacron

•

the interior of each SPR® sleeve (see Fig. 6-2).

•

Repeat the previous operation using a new Dacron swab moistened with a
bleach solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Rinse each SPR sleeve using a new Dacron swab moistened with
demineralized water.

®

swab moistened with a detergent solution, carefully clean

6

7

8

9

VIDAS

Fig. 6-3: Cleaning the rear of the SPR® block

•

Using curved forceps, moisten a sponge with detergent and swab the rear
of the SPR block, pushing each SPR sleeve individually back towards the
interior of the section (see figure opposite).

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a sponge with demineralized water. Holding the sponge with curved
forceps rinse the SPR

®

Instrument User's manual 6-7

®

sleeves.

10

Maintenance

Decontamination of the VIDAS blue

• Close the SPR block door.

Fig. 6-4: Do not clean the seals situated above the SPR block

CAUTION! Do not clean the seals situated above the SPR block (see Fig. 6-4) as they

do not require cleaning other than when preventive maintenance is
performed by the bioMérieux® Field Service Technician.
In the event of accidental spills or contamination, it is imperative that you
call bioMérieux Technical Assistance. Any handling of the seals may affect
the performance of your instrument.

Cleaning the strip preparation tray

(monthly)

Lift the handle on the strip preparation tray and tilt the tray forwards.

•

The strip preparation tray will open.

②

Fig. 6-5: Opening the strip preparation tray

6-8 VIDAS

①

®

Instrument User's manual

Maintenance

Decontamination of the VIDAS blue

6

④

③

Fig. 6-6: Cleaning the strip preparation tray

•

Using curved forceps and a sponge moistened with a detergent, carefully
clean the front of the strip preparation tray

4 by sliding the sponge along each one.

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Carefully rinse using curved forceps and a new sponge moistened with
demineralized water.

3 (Fig. 6-6) and the 6 channels

7

8

9

VIDAS

®

Instrument User's manual 6-9

10

Maintenance

Decontamination of the VIDAS blue

Cleaning the reagent strip trays

(monthly)

Raise the strip preparation tray until it is in its upright position.

•

•

Use a suitable screwdriver to remove the 2 screws ① located under the
strip preparation tray.

•

Open the strip preparation tray by tilting it forwards.

①

Fig. 6-7: Dismantling the strip preparation tray

• With one hand (finger and thumb), grasp the 2 tabs inside the strip

preparation tray, squeeze gently and pull forwards to remove the tray (see
Fig. 6-8).

Fig. 6-8: Removing the strip preparation tray

This gives access to the reagent strip tray.

• Repeat this operation for each compartment.

6-10 VIDAS

®

Instrument User's manual

Maintenance

Decontamination of the VIDAS blue

• Manually pull the reagent strip trays d to their outermost position (see Fig.

6-9).

Fig. 6-9: Repositioning the strip sections trays

•

Moisten a sponge in the detergent solution. Holding the sponge with curved
forceps, carefully clean the 6 channels of the reagent strip tray by sliding the

sponge along each channel.

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a new sponge with demineralized water. Holding the sponge with
curved forceps, rinse each tray.

•

Push the reagent strip trays d back in until they engage the tray drive
mechanism (see Fig. 6-9).
You will feel a slight resistance during engagement.

6

7

8

9

VIDAS

®

Instrument User's manual 6-11

10

Maintenance

Decontamination of the VIDAS blue

Cleaning the spill tray

(monthly)

Remove the plastic tray e that sits underneath each reagent strip tray by

•

sliding it towards you (see Fig. 6-10).

Fig. 6-10: Cleaning the spill tray

•

Clean each tray with a sponge moistened with a detergent solution.

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a new sponge with demineralized water. Holding the sponge with
curved forceps, rinse each tray.

•

Carefully replace each tray e. The edges of the tray must fit into the plastic
grooves on each side.

e

WARNING! The spill tray

the reagent strip tray.

6-12 VIDAS

must slide BELOW the electric wire f that is underneath

®

Instrument User's manual

Maintenance

Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference

30706

Reassembling the strip preparation tray and switching the analytical module
back on

CAUTION!

CAUTION!

Wait until all the parts are dry before reassembling them.

Reassembling the strip preparation tray:

•

Slide the strip preparation tray into its housing.

A "click" indicates that the strip preparation tray has been properly reassembled.

Raise the strip preparation tray and screw the 2 screws back into place.

•

Slide it back down into position.

•

The VIDAS blue should not be used when the strip preparation tray is not
in place.

Powering on the analytical module:

•

Reconnect the module to the power supply.

•

Turn the power switch to the "ON" position.

•

Leave the module to pre-heat for 45 minutes.

•

Turn the power switch to the "OFF" position.

•

Wait for approximately 1 minute and turn the power switch to the "ON"
position.

•

Wait for the module to reset (approximately 10 minutes) before attempting to
use it again.

6

7

8

WARNING! Dispose of sponges and swabs according to acceptable procedures for

biohazardous material.

Using the reagent for testing the pipette mechanisms:
Quality Control VIDAS (QCV) – Reference 30706

This control reagent is a simple and rapid technique for testing the pipette

VIDAS® Instrument User's manual 6-13

mechanisms of your VIDAS instrument. You must perform the QCV test on all
the VIDAS instrument positions at least once a month or anytime that a pipetting
problem is suspected.

For further information on this test, refer to the package insert included in the kit.

Read the package insert carefully before performing the test.

9

10

Maintenance

Decontamination of the VIDAS

Decontamination of the VIDAS

Decontamination involves:

− Routine decontamination which should be performed on a periodic basis.

− Cleaning of accidental spills (accidental contamination), which should be

dealt with immediately.

DANGER ! Turn the VIDAS power switch to "OFF" and then disconnect the power

cord.
Use POWDERLESS disposable gloves.
This operation must be performed once all assays are completed.
Do not allow disinfectant solution to spill into the instrument.

Fig. 6-11: Removing the front panel

• Remove the screws from the front panel c of the module below the reagent

strip trays and pull the panel off (see Fig. 6-11).

6-14 VIDAS

®

Instrument User's manual

Cleaning the SPR® block

(weekly)

Maintenance

Decontamination of the VIDAS

DANGER ! This operation must be performed once all assays are completed. Use

POWDERLESS disposable gloves.

Do not allow disinfectant solution to spill into the instrument.

Fig. 6-12: Cleaning the SPR® block

•

Open the door of the section containing the SPR block.

•

Using a Dacron
the interior of each SPR sleeve (see Fig. 6-12).

®

swab moistened with a detergent solution, carefully clean

6

7

8

9

VIDAS

•

Repeat the previous operation using a new Dacron swab moistened with a
bleach solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Rinse each SPR sleeve using a new Dacron swab moistened with
demineralized water.

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Instrument User's manual 6-15

10

Maintenance

Decontamination of the VIDAS

•

•

Fig. 6-13: Cleaning the rear of the SPR® block

Using curved forceps, moisten a sponge with detergent and swab the rear
of the SPR block, pushing each SPR sleeve individually back towards the
interior of the section (see Fig. 6-13).

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a sponge with demineralized water. Holding the sponge with curved
forceps rinse the SPR sleeves.

•

Close the SPR block door.

Fig. 6-14: Do not clean the seals situated above the SPR block

CAUTION!

6-16 VIDAS

Do not clean the seals situated above the SPR® block (see Fig. 6-14) as
they do not require cleaning other than when preventive maintenance is
performed by the bioMérieux® Field Service Technician.
In the event of accidental spills or contamination, it is imperative that you
call bioMérieux Technical Assistance.
Any handling of the seals may affect the performance of your instrument.

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Instrument User's manual

Cleaning the reagent strip trays

(monthly)

Manually pull the reagent strip trays d to their outermost position (see Fig.

•

6-15).

Maintenance

Decontamination of the VIDAS

6

7

②

Fig. 6-15: Repositioning the strip sections trays

•

Moisten a sponge in the detergent solution. Holding the sponge with curved
forceps, carefully clean the 6 channels of the reagent strip tray by sliding the

sponge along each channel.

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a new sponge with demineralized water. Holding the sponge with
curved forceps, rinse each tray.

8

9

VIDAS

•

Push the reagent strip trays d back in until they engage the tray drive
mechanism (see Fig. 6-15).
You will feel a slight resistance during engagement.

®

Instrument User's manual 6-17

10

Maintenance

Decontamination of the VIDAS

Cleaning the spill tray

(monthly)

•

Remove the plastic tray e that sits underneath each reagent strip tray by
sliding it towards you (see Fig. 6-16).

Fig. 6-16: Cleaning the spill tray

•

Clean each tray with a sponge moistened with a detergent solution.

•

Repeat the previous operation using a new sponge moistened with a bleach
solution containing 0.5-0.6% active chlorine (5.5 to 6.6 g/l sodium
hypochlorite); these solutions should be prepared in demineralized water.

•

Allow the bleach solution to react for 10 minutes.

•

Moisten a new sponge with demineralized water. Holding the sponge with
curved forceps, rinse each tray.

•

Carefully replace each tray e. The edges of the tray must fit into the plastic
grooves on each side.

e

WARNING! The spill tray

the reagent strip tray.

6-18 VIDAS

must slide BELOW the electric wire f that is underneath

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Instrument User's manual

Maintenance

Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706

Replacing the front panel and switching the analytical module back on

Fig. 6-17: Replacing the front panel

•

Replace the front panel c (see Fig. 6-17).

•

Reconnect the module to the power supply.

•

WARNING! Dispose of sponges and swabs according to acceptable procedures for

Turn the power switch to the "ON" position.

•

Leave the module to pre-heat for 45 minutes.

•

Turn the power switch to the "OFF" position.

•

Wait for approximately 1 minute and turn the power switch to the "ON"
position.

•

Wait for the module to reset (approximately 10 minutes) before attempting to
use it again.

biohazardous material.

6

7

8

9

Using the reagent for testing the pipette mechanisms:
Quality Control VIDAS (QCV) – Reference 30706

VIDAS

®

Instrument User's manual 6-19

This control reagent is a simple and rapid technique for testing the pipette
mechanisms of your VIDAS instrument. You must perform the QCV test on all
the VIDAS instrument positions at least once a month or anytime that a pipetting
problem is suspected.

For further information on this test, refer to the package insert included in the kit.

Read the package insert carefully before performing the test.

10

Maintenance

Computer

Computer

Cleaning the screen

(as required)

From any window (no assays should be in progress):

Quit all programs by clicking on the icon in the top right-hand corner of

•

the windows.

To shut down the computer,

• Click on the button in the bottom left-hand corner of the screen or

press one of the "Windows" keys either side of the space bar,

Select "Shut down". •

Fig. 6-18: Shutting down Windows®

6-20 VIDAS

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Instrument User's manual

Maintenance

Computer

The following window appears:

•

Select "Shut down".

•

Click "OK".

The computer will stop and shut down.

•

Switch off the computer (if necessary) and the screen.

•

Clean the screen with a dry anti-static cloth or use a special screen cleaner.

•

Turn on the screen and the computer.

Refer to the section entitled "Starting VIDAS PC" in Chapter 3 of the VIDAS PC
User's Manual.

VIDAS retests some of its mechanical and optical systems.

The

Fig. 6-19: Shutting down the computer

6

7

8

9

VIDAS

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Instrument User's manual 6-21

10

Maintenance

Printer

Printer

Cleaning

(monthly)

Refer to the Printer User’s Manual.

•

WARNING! Never use alcohol or solvents to clean the printer as these chemicals

could damage components or the housing.

Do not allow water to spill into the printing mechanism or onto electronic
components.

Do not use hard-bristle brushes or abrasive materials.

Do not spray lubricants into the printer.

Replacing the ink cartridge

(as required)

As soon as the print quality begins to deteriorate,

•

Change the ink cartridge.

To do so:

•

Refer to the Printer User’s Manual.

Bar code reader

Cleaning

(as required)

Clean the reader window using a soft cloth.

•

6-22 VIDAS

®

Instrument User's manual

7 Troubleshooting

Introduction

This chapter describes the problems that may occur with the bar code reader.

In case of a problem, see Chapter 12 "Troubleshooting" in the VIDAS PC User's
Manual.

VIDAS

®

Instrument User's manual 7-1

Troubleshooting

Bar code reader

The reader does not emit a beam of light

•

Check that the computer is switched on.

•

Check that the cables are securely connected (see the procedure for
connection, page 4-8).

•

Check that the trigger is working.

After verification, if the reader does not function properly:

•

Repeat the installation procedure in section "Starting the VIDAS".

If the problem persists, call bioMérieux® Technical Assistance or your local
bioMérieux representative.

Reader fails to read bar codes

There are several possibilities:

− The bar codes are unreadable:

IMPORTANT! To be readable, bar codes must be complete, unstained and untorn.

If the configuration sheet provided with the reader is missing or unreadable, call
bioMérieux Technical Assistance or your local bioMérieux representative.

− The reader window is not clean:

Error 161

Note:

•

Check that the reader window is clean and if necessary clean it using a
soft cloth.

•

Repeat the reading.

− The reading distance is incorrect:

•

Slowly move the reader away from and/or towards the bar code until the
optimal position for reading has been reached.

A beep indicates that reading has been performed.

− A keyboard error has occured:

•

Check that the upper case key (<Maj> or <Caps lock>) is disabled.

•

Repeat the reading.

If these failures recur, call bioMérieux Technical Assistance or your local
bioMérieux representative.

If the VIDAS PC software displays "Error 161" following a reading:

•

Refer to Chapter 12 in the VIDAS PC User’s Manual.

7-2 VIDAS

®

Instrument User's manual

8 Glossary

ASSAY ANALYSIS

ASSAY CODE

ASSAY COMPATIBILITY

ASSAY KIT

BAR CODE

BCI

Interpretation of data using sample assay data, standard assay data, and

thresholds for data comparison.

These calculations can be different for each type of assay and enable
interpretation of the assay result.

A two-, three- or four-character designation for an assay used in the VIDAS.

Assays are entered into the system, for example, to create a Work List,
using the assay code.

A property in which two or more assays use the same .

A package containing a set of Reagent Strips, SPR®s, and a package insert

along with any necessary controls, standards, sample treatment agents and
the MLE card.

A series of lines printed on the label of a Reagent Strip and on the MLE

card. The encoded information can be read and interpreted by the scanner
and used to identify the strip.

Bidirectional Computer Interface (bidirectional connection between 2

computers).

CALIBRATION

CENTRAL PROCESSING

UNIT

CONFIGURATION

CONNECTION

®

VIDAS

Instrument User's manual 8-1

The process of adjusting the standard curve of a quantitative assay lot or

storing of the calibrator’s RFV for a qualitative assay.

The portion of a computer that is responsible for processing software

instructions.

A group of elements consisting of an instrument, its operating software and

the peripheral(s) which can be connected to it. .

Link between the computer and the peripherals or with the central laboratory

information system via input and output ports.

Glossary

DUAL REAGENT STRIP

FLUORESCENCE

OPTICAL CUVETTE

OPTICAL SCANNER

POSITION

PREDEFINED SECTION

PROTOCOL

A strip consisting of a jointly attached sample reference Reagent Strip (left)

and a sample test Reagent Strip (right).

A physical process in which a substance emits light at a certain wavelength

after exposure to light at another wavelength. This is the measurement
process used in the VIDAS.

The last well on the Reagent Strip. It is made of optically clear plastic that

permits the scanner to take an accurate fluorometric reading of the
substrate.

A component of the analytical module which reads bar codes and measures

the intensity of fluorescence of an assay.

A section consists of 6 positions numbered from 1 to 6 from left to right.

Each position corresponds to a SPR

Compatible tests (max. 6) grouped under the same number.

A specific sequence of computer-controlled activities (pipetting, mixing,

incubating, reading, etc.) needed to perform an assay.

®

slot in the SPR block.

REAGENT

REAGENT STRIP

REAGENT STRIP TRAY

RESERVED

RESULT

8-2 VIDAS

A package consisting of a single or a dual strip and a SPR.

A polypropylene strip of 10 wells with a foil seal and paper label. The first

well is the sample well and the other eight wells contain the various
reagents required for the immunoassay. The last well of the strip is the
optical cuvette containing the substrate.

A temperature-controlled tray with a plastic cover that can hold six reagent

strips or three dual reagent strips. Also called Section tray.

A reserved predefined section is one in which the system assigns the

Reagent Strips and SPRs to specific positions in the analytical module.

The interpretation of the test value in a defined unit.

®

Instrument User's manual

RFV

Glossary

Relative Fluorescence Value. The difference between the final and the initial

(background) fluorescent readings of a reagent strip.

SAMPLE

SECTION

SEQUENCE NUMBER

SPR®

®

SPR

BLOCK

STANDARD

The patient material being tested.

A microprocessor-controlled assay processing unit in the VIDAS instrument.

Each module has five sections, labeled A through E. Each incubator
contains a SPR® block with channels for six Reagent Strips or three Dual
Reagent Strips. A SPR position and its corresponding Reagent Strip
channel make up one test position.

A number printed on the Reagent Strip and encoded into the bar code. It

can be read by the optical scanner and printed on the assay report. It
uniquely identifies a particular reagent strip.

A specially designed plastic pipette-shaped device with its inside wall coated

with antibody, antigen, or other treatments that allow capture of a target
analyte. Each SPR has a corresponding Reagent Strip.

A temperature-controlled block with receptacles to hold six SPRs. Each has

a position for a corresponding Reagent Strip immediately below it in the
section. A tilt-down door provides access to the SPR

A solution containing a known analyte concentration. The RFV obtained

from testing a standard is used to calculate concentrations and to interpret
patient samples or controls.

®

.

6

7

8

9

STRIP PREPARATION

TRAY

SUBSTRATE

TARGET ANALYTE

TEST

®

VIDAS

Instrument User's manual 8-3

A tray with 6 positions located under each reagent strip tray. It is used to

prepare tests for a specific section as it can hold either 6 individual strips or
the boat included in the reagent kit.

A substance in the Reagent Strip that is broken down enzymatically to

create a compound that fluoresces.

10

A biological element to be assayed (antigens, antibodies, …)

Term which refers to the combination of sample identifier (sample ID or

patient ID) and assay code with which the analysis is to be performed.

Glossary

TEST VALUE

VIDAS MODULE

For qualitative tests. The result calculated by VIDAS using the RFV

(Relative Fluorescence Value) of the sample and which enables the
interpretation of results.

The VIDAS analyzer / reader.

8-4 VIDAS

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Instrument User's manual