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® SA products, software or services which are not available in the country of release; this shall not mean that bioMérieux SA intends to market such products, software or services in such country

To request copies of publications or for any technical request, contact bioMérieux SA or your local distributor.

L i a b i l i t y d i s c l a i m e r

This manual is provided “AS IS” without any warranty, whether express or implied, of merchantability, safety, quality, accuracy, performance of products described on this manual, including an implied warranty of merchantability or fitness for a particular purpose, non infringement of third parties intellectual property rights and against an incidental or direct damage.

In no event shall bioMérieux SA be liable for any direct or indirect damage or consequence related to, arising out of or in connection with, any use of this manual and/or its results by the User and/or any third party.

In no event shall this manual be construed as an undertaking of bioMérieux SA, who reserves the right to modify this manual without notice and shall incur no liability as a result of such modification.

This manual is provided for information purposes only and except for the present provisions does not constitute a binding document legally.

I n t e l l e c t u a l P r o p e r t y

bioMérieux SA is the sole owner of copyright, patrimonial rights and any other intellectual property rights in and to this manual and its content subject to possible third parties rights.

This manual and its content are protected under the provisions of section L.111-1 and following articles of the French Intellectual Property Code and International Copyright and Author Rights Treaties.

The rights to use this manual granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument. In no event shall the Users be granted herein any other right to use this manual including without limitation, the right to reproduce, represent, adapt or translate all or part of this manual by any mean whatsoever and in any country without the prior written consent of bioMérieux SA.

Any use of this manual other than expressly permitted hereunder shall be prosecuted.

IMPORTANT! USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE CLAUSES ABOVE MENTIONED.

bioMérieux, the blue logo and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries.

Windows is a used, pending and/or registered trademark belonging to Microsoft Corporation. Dacron is a used, pending and/or registered trademark belonging to Invista North America, SARL. 7X is a used, pending and/or registered trademark belonging to MP Biomedicals, LLC.

Alconox and Liquinox are used, pending and/or registered trademarks belonging to Alconox, Inc.

V.B 02/2005

General Warnings

DANGER!

All biological fluids should be considered as potentially infectious.

Protective gloves must be worn when manipulating blood, products derived from blood or objects contaminated with blood.

Qualified laboratory personnel should use acceptable procedures for biohazardous material.

IMPORTANT! The configuration that you have purchased is adapted to the legislation and standards of the different countries it will be sent to.

For this reason, it may differ from the one presented in this document. However, it will not prevent VIDAS® from operating correctly.

This product is an in vitro diagnostic medical device. It complies with the directives and standards mentioned in the certificate supplied with it.

The user is advised to read and understand all instructions in this manual to be able to derive the best performance from the VIDAS.

bioMérieux SA recommends that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied.

The accuracy of results obtained with this instrument depends, in particular, on the maintenance operations described in this manual.

The user should be aware that, if the maintenance operations are not performed, are only partially performed, or are not performed as described in this manual, bioMérieux SA is in no case liable for any false test results obtained.

bioMérieux SA is in no case liable for any changes made to the equipment without authorization from bioMérieux SA.

IMPORTANT!	Electromagnetic Compatibility (EMC):
	This is a Class A product.
	In a residential area, this product may cause harmful interference in which
	case the user may be required to take adequate measures at his own
	expense.
	The equipment may also cause inteference if not installed in accordance
	with the instructions given in this manual.
	This statement only applies to European countries and instruments
	bearing the	symbol with regard to the waste electrical and electronic

equipment European directive.

You can play an important role in contributing to reuse, recycling and other forms of recovery of waste electrical and electronic equipment. Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment.

At the end of the life cycle of this product, do not dispose of the product as unsorted municipal waste, even if it is decontaminated. It is imperative that you contact bioMérieux to assure for its appropriate disposal.

Revisions

The list of revisions below summarizes replacements or additional pages in your

VIDAS Instrument User’s Manual.

Manual	Reason	Page(s)
V.A 03.2005	New VIDAS model	All
V.B 12.2005	New software version	All

VIDAS® Instrument User's manual

Revisions-1

Table of Contents

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

I n t r o d u c t i o n

	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

F i n d i n g t o p i c s a n d p r o c e d u r e s

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

1-2	VIDAS® Instrument User's manual

How to use this manual

Typographic conventions

T y p o g r a p h i c c o n v e n t i o n s

	The following typographic conventions are used throughout this manual.
	1
• 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.

W a r n i n g s

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!).

VIDAS® Instrument User's manual

1-3

How to use this manual

Graphic symbols

G r a p h i c s y m b o l s

V.A 09/2003 – màj smn –10/2004

The standard symbols used for the bioMérieux systems and their meanings can be found below:

Direct current

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) TERMINAL

PROTECTIVE CONDUCTOR TERMINAL

Frame or chassis TERMINAL

Equipotentiality

ON (power supply)

OFF (power supply)

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

1-4	VIDAS® Instrument User's manual

How to use this manual

Graphic symbols

	"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)	1
	Risk of electric shock
	Caution: see accompanying documents
	High temperature
	Potential pinch point
	Potential biohazard
i	Consult Instructions for Use
LOT	Batch code
or REF	Catalogue number
	Temperature limitation
EC REP	Authorised representative of the European Community
	Keep dry

VIDAS® Instrument User's manual

1-5

How to use this manual

Graphic symbols

	Manufacturer
	Date of manufacture
IVD	In Vitro Diagnostic Medical Device
SN or SN	Serial number
	Keep away from magnetic field
	Separate collection for waste electrical and electronic equipment

1-6	VIDAS® Instrument User's manual

2 Functional description

I n t r o d u c t i o n

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

Functional description

Description / aim

D e s c r i p t i o n / a i m

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®s and reagent strips,

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

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

		− the package insert.	2
	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.

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

−reliable results,

−ease-of-use,

−rapid analyis results.

VIDAS stands for: Vitek® Immuno Diagnostic Assay System.

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.

VIDAS® Instrument User's manual

2-3

Functional description

Configuration components

C o n f i g u r a t i o n c o m p o n e n t s

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 (optional)

Fig. 2-2: Configuration components (example)

2-4	VIDAS® Instrument User's manual

Functional description

Configuration components

The VIDAS can be divided into three categories of components :

−hardware,

−software,

−consumables.

Hardware

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,	2

−a screen,

−a bar code reader,

−a printer.

CAUTION!	Never use material other than that specified by bioMérieux®.
Software	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 unior bidirectional interface (optional).
IMPORTANT!	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.
Consumables	Assay kit (60, 30 or 10 tests).

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.

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	Functional description
	Configuration components
Microprocessor	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 independent and autonomous.
	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.
Reagent strip tray	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	2
	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.

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.

Note:	For further information on the MLE card, see the VIDAS PC User's Manual.
	CAUTION!	The reagent strip trays are movable parts. The risk of
		finger pinching exists.

VIDAS® Instrument User's manual

2-7

Functional description

Configuration components

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

(only concerns

VIDAS blue)

Fig. 2-4: Strip preparation tray closed

Fig. 2-5: Opening the strip preparation tray

Fig. 2-6: Reagent strips placed on	Fig. 2-7: Reagent strips placed on
the strip preparation tray	the strip preparation tray with their
	boat

2-8	VIDAS® Instrument User's manual

	Functional description
	Configuration components
SPR® block	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.

2

Fig. 2-8: SPR block

VIDAS® Instrument User's manual

2-9

Functional description

Configuration components

Incubator	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.
Note:	To display the SPR block and tray temperatures, see the VIDAS PC User's Manual.
Bar code readers	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.
Detection system	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