Biomerieux Vidas PC User Manual

REF : 93 073

Version : F

05/2008

VIDAS

®

PC

User's Manual

bioMérieux S.A. 69280 Marcy l'Etoile / France

Tel. [phone] - Fax [phone]

http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

© 2005-2008.bioMérieux, S.A.

4501-1714-en

4501-1584 E 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

Room 1601-02B & 10

Est Ocean Centre

n° 24A Jiang Guo Men Nei Street,

100004 Beijing

tel. [phone]

fax [phone]

bioMérieux China Limited

Room 2605, South Tower,

World Trade Center

371-375 Huan Shi Dong East Road

510095 Guangzhou

tel. [phone]

fax [phone]

Colombia

bioMérieux Colombia Ltda

Avenida 15 No. 100-43

Piso 2

Bogotá D.C.

tel. [phone]

fax [phone]

Czech republic

bioMérieux CZ s.r.o.

Business Park Kosice,

Jinonická 80

158 00 Praha 5

tel. (420)

2 57 290 623 / (420) 2 57 290 232

fax [phone]

Denmark

bioMérieux Danmark Aps

Smedeholm 13C,

2730 Herlev

tel. [phone]

fax [phone]

Finland

bioMérieux Suomi Oy

Konalantie 47 C

FI-00390 Helsinki

tel. [phone]

fax [phone]

France

bioMérieux S.A.

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

bioMérieux Hungária Kft.

Fóti út. 56 (5

th

Floor)

H-1047 Budapest

tel. [phone]

fax [phone]

India

bioMérieux India Pvt. Ltd

A-32, Mohan Co-Operative Ind. Estate

New Delhi 110 024

tel. [phone]

fax [phone]

Indonesia

Representation office

bioMérieux Indonesia

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

1

st

& 2

nd

Floor, Yoosung Building

# 830-67 Yoksam-dong, Kangnam ku

Seoul 135-080

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

C/- Logical Freight Solutions

12 C Rennie Drive, Airport Oaks

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 Warsaw

tel. [phone]

fax [phone]

Portugal

bioMérieux Portugal, Lda.

Av. 25 de Abril de 1974, nº 23 – 3º

2795-197-LINDA-A-VELHA

tel. [phone]

fax [phone]

Russia

o.o.o. bioMérieux

Derbenevskaya ul. 20, str. 11

115 114 Moscow

tel. [phone]

fax [phone]

Spain

bioMérieux España S.A.

Manual Tovar, 45-47

28034 Madrid

tel. [phone]

fax [phone]

Sweden

bioMérieux Sverige AB

Hantverksvägen 15

436 33 Askim

tel. [phone]

fax [phone]

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc

Case postale 2150

1211 Genève 2

tel. [phone]

fax [phone]

Taiwan

Representation office

bioMérieux China Limited - Taiwan Branch

RM 608, No. 6-3 Ching Cheng Street

Taipei 105

tel. [phone]

fax [phone]

Thaïland

bioMérieux Thaïland Ltd

Regent House Bldg, 16 th Floor

183 Rajdamri Road, Lumpini, Pathumwan

Bangkok 10330

tel. [phone]

fax [phone]

Turkey

bioMérieux Diagnostik A.S.

Değirmen Sok. Nida Plaza Kat:6

34742 Kozyataği / Istanbul

tel. [phone]

fax [phone]

United Kingdom

bioMérieux UK Ltd

Grafton Way, Basingstoke

Hampshire RG22 6HY

tel. [phone]

fax [phone]

USA

bioMérieux, Inc.

100 Rodolphe Street

Durham NC 27712

tel. [phone]

fax [phone]

Vietnam

Representation office

bioMérieux (Thailande) Ltd. Rep. Office

in Vietnam

Room 4A, 4th Floor

Green House Building

62A Pham Ngoc Thach Street, Ward 6

District 3

Ho Chi Minh City

tel. [phone]

fax [phone]

Distribution in over 130 countries

4501-1618 A en

The content of this manual is based on the Software release 4.0.0 and later Software

releases.

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 S.A. products, software or services which are not available in the country

of release; this shall not mean that bioMérieux S.A. intends to market such products,

software or services in such country

To request copies of publications or for any technical request, contact

bioMérieux S.A. or your local distributor.

Liability disclaimer

THIS MANUAL IS PROVIDED "AS IS" WITHOUT ANY WARRANTY, EITHER EXPRESS OR

IMPLIED

, OF MERCHANTABILITY, SAFETY, QUALITY, ACCURACY OR THE PERFORMANCE OF

PRODUCTS DESCRIBED IN THIS MANUAL

. IN ADDITION, THERE SHALL BE NO IMPLIED

WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE

, NOR NON

INFRINGEMENT OF THIRD PARTIES

' INTELLECTUAL PROPERTY RIGHTS.

In no event shall bioMérieux S.A. be liable for any direct, consequential, incidental 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 S.A.

bioMérieux S.A. 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.

Intellectual Property

bioMérieux S.A. is the sole owner of copyright, patrimonial rights and any other

intellectual property rights in and to this manual and its content, except for the

potential third parties' rights.This manual and its content are protected under the

p r o v i s i o n s o f s e c ti o n 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 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 means

whatsoever without the prior written consent of bioMérieux S.A.

Any use of this manual other than expressly permitted hereunder may be

prosecuted.

IMPORTANT!

USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE TERMS AND

CONDITIONS SET FORTH HEREIN.

bioMérieux, the blue logo, VIDAS, BCI RS232 and BCI NET are used, pending and/or registered trademarks

belonging to bioMérieux S.A. or one of its subsidiaries.

Windows and Excel are used, pending and/or registered trademarks belonging to Microsoft Corporation.

4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.:

Software: VIDAS PC, BCI RS232 and/or BCI NET

Release:

Computer: Brand name:

Printer: Brand name:

Disk player: Brand name:

IMPORTANT! The use of this Software is strictly governed by the following terms and

conditions.

I – Purpose of this Agreement / Rights granted

bioMérieux S.A. hereby grants, to the User who, by using this manual, accepts a

non-exclusive right to use the Software. The license is personal, non transferable,

non assignable and does not comprise the right to grant sub-licenses.

The User expressly agrees, in its own name and behalf as well as in the name and

on behalf of its employees, agents and collaborators, not to make any copy of the

Software-except one single backup copy for archival purposes- display the Software

on any computer other than the Computer, reproduce, sell, rent, lease, modify,

adapt, translate or otherwise dispose of, all or part of the Software, the equipment,

the user manual and its related documentation.

Specifically, the User agrees not to decompile, reverse engineer or disassemble all

or part of the Software.

II – Intellectual Property

All intellectual property rights including patrimonial rights, in and to the Software are

and shall remain bioMérieux S.A. exclusive property, subject to possible third party

rights. Consequently, the User is not entitled to copy or reproduce the Software

except as set forth above.

Except as expressly specified above, nothing contained herein shall be construed as

conferring to the User any right, title or interest in and to the Software.

III – Warranties

Provided that this Agreement duly signed is received by bioMérieux S.A. within ten

(10) business days from the delivery, bioMérieux S.A. warrants that the Software is

free from defect in materials and workmanship under normal conditions of use during

three (3) months from the delivery. Should any defect occur during such period,

bioMérieux S.A. or one of its authorized distributors in the country of sale shall

replace the Software provided that the User makes its request in writing together with

copy of the Software invoice and, as the case may be, the defective media.

Apart from the foregoing, the Software is provided "AS IS" and no warranty, whether

express or implied, of merchantability, safety, quality, or fitness for a particular

purpose is given hereunder nor any warranty that the Software shall not infringe

upon the intellectual property rights of any third party.

The warranty provided herein shall apply provided that Software is used under

normal conditions and to the exclusion of any replacement caused by accidental or

willful damage, or misuse of the software or accident whatsoever.

It is expressly understood that, according to this License, bioMérieux S.A. shall not

perform any service related to the training, assistance or maintenance of the

Software unless otherwise agreed upon between the parties through a separate

written agreement setting forth the terms and conditions (in particular, financial

conditions) of such training, assistance or maintenance.

IV – Liability

In no event shall bioMérieux S.A. be liable for consequences related to, arising out of

or in connection with, modifications of Software by anyone other than

bioMérieux S.A.

In no event shall bioMérieux S.A. be liable for any direct, indirect, special,

consequential, incidental or material damage (including loss of goodwill, profits, data

or any other economic advantage) related to, arising out of or in connection with, any

use of the Software and/or its results by the User and/or any third party, including

without limitation, its clients, customers and sub-contactors. User hereby agrees to

indemnify, defend and hold bioMérieux S.A. harmless from all claims, damages,

expenses, suits, losses or liabilities relating to, arising out of or in connection with

User or such parties as well for any action of such third parties against

bioMérieux S.A.

Should this provision be held unenforceable or void, the User irrevocably agrees that

bioMérieux S.A. liability and expenses for all causes shall not exceed the total

amount actually paid by the User hereunder for the software release concerned by

the claim.

V – Applicable Law and settlement of disputes

This agreement is governed and construed in accordance with French Law.

Parties shall make their best efforts to settle any dispute through amicable

discussions. In the event no amicable settlement is reached in the period of three (3)

months after communication of the claim, any litigation shall be held in the exclusive

jurisdiction of the courts of Lyon, France.

Done..............................................................................

This…….....................day of .........................................

Signature and User's stamp:

COPY TO BE RETURNED TO BIOMERIEUX

S.A.

4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.:

Software: VIDAS PC, BCI RS232 and/or BCI NET

Release:

Computer: Brand name:

Printer: Brand name:

Disk player: Brand name:

IMPORTANT! The use of this Software is strictly governed by the following terms and

conditions.

I – Purpose of this Agreement / Rights granted

bioMérieux S.A. hereby grants, to the User who, by using this manual, accepts a

non-exclusive right to use the Software. The license is personal, non transferable,

non assignable and does not comprise the right to grant sub-licenses.

The User expressly agrees, in its own name and behalf as well as in the name and

on behalf of its employees, agents and collaborators, not to make any copy of the

Software-except one single backup copy for archival purposes- display the Software

on any computer other than the Computer, reproduce, sell, rent, lease, modify,

adapt, translate or otherwise dispose of, all or part of the Software, the equipment,

the user manual and its related documentation.

Specifically, the User agrees not to decompile, reverse engineer or disassemble all

or part of the Software.

II – Intellectual Property

All intellectual property rights including patrimonial rights, in and to the Software are

and shall remain bioMérieux S.A. exclusive property, subject to possible third party

rights. Consequently, the User is not entitled to copy or reproduce the Software

except as set forth above.

Except as expressly specified above, nothing contained herein shall be construed as

conferring to the User any right, title or interest in and to the Software.

III – Warranties

Provided that this Agreement duly signed is received by bioMérieux S.A. within ten

(10) business days from the delivery, bioMérieux S.A. warrants that the Software is

free from defect in materials and workmanship under normal conditions of use during

three (3) months from the delivery. Should any defect occur during such period,

bioMérieux S.A. or one of its authorized distributors in the country of sale shall

replace the Software provided that the User makes its request in writing together with

copy of the Software invoice and, as the case may be, the defective media.

Apart from the foregoing, the Software is provided "AS IS" and no warranty, whether

express or implied, of merchantability, safety, quality, or fitness for a particular

purpose is given hereunder nor any warranty that the Software shall not infringe

upon the intellectual property rights of any third party.

The warranty provided herein shall apply provided that Software is used under

normal conditions and to the exclusion of any replacement caused by accidental or

willful damage, or misuse of the software or accident whatsoever.

It is expressly understood that, according to this License, bioMérieux S.A. shall not

perform any service related to the training, assistance or maintenance of the

Software unless otherwise agreed upon between the parties through a separate

written agreement setting forth the terms and conditions (in particular, financial

conditions) of such training, assistance or maintenance.

IV – Liability

In no event shall bioMérieux S.A. be liable for consequences related to, arising out of

or in connection with, modifications of Software by anyone other than

bioMérieux S.A.

In no event shall bioMérieux S.A. be liable for any direct, indirect, special,

consequential, incidental or material damage (including loss of goodwill, profits, data

or any other economic advantage) related to, arising out of or in connection with, any

use of the Software and/or its results by the User and/or any third party, including

without limitation, its clients, customers and sub-contactors. User hereby agrees to

indemnify, defend and hold bioMérieux S.A. harmless from all claims, damages,

expenses, suits, losses or liabilities relating to, arising out of or in connection with

User or such parties as well for any action of such third parties against

bioMérieux S.A.

Should this provision be held unenforceable or void, the User irrevocably agrees that

bioMérieux S.A. liability and expenses for all causes shall not exceed the total

amount actually paid by the User hereunder for the software release concerned by

the claim.

V – Applicable Law and settlement of disputes

This agreement is governed and construed in accordance with French Law.

Parties shall make their best efforts to settle any dispute trough amicable

discussions. In the event no amicable settlement is reached in the period of three (3)

months after communication of the claim, any litigation shall be held in the exclusive

jurisdiction of the courts of Lyon, France.

Done..............................................................................

This…….....................day of .........................................

Signature and User's stamp:

COPY TO BE KEPT BY USER

General warnings

DANGER ! All biological fluids should be considered as potentially infectious.

Powderless 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.

You are advised to read and understand all the instructions in this

manual to be able to derive the best performance from your VIDAS.

bioMérieux



SA recommends that you observe the different

warnings inscribed on the instrument itself and indicated in the

documentation supplied.

The equipment may also cause inteference if not installed in

accordance with the instructions given in this manual.

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.

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.

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. Please contact bioMérieux or its distributor

in order to organize its collection.

VIDAS

®

PC User's Manual Revisions-1

Revisions

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

VIDAS PC User’s Manual.

Manual Reason Page(s)

V.C 08.2003 Update of a few screens + text 1-7,1-8,

1-11, 2-3,

3-7, 3-8, 4-2,

4-5,5-21,

6-6, 6-7,

11-17

V.D. 03.2005 Modification relating to the new

VIDAS model

All

V.E. 12.005 New VIDAS software version All

V.F 05.2008 Addition of a backup mode Chapter 9

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.................................................................................................................................. 2-2

General features .................................................................................................................................. 2-3

Principle of operation ........................................................................................................................... 2-3

3 Getting started 3-1

Safety instructions................................................................................................................................ 3-2

Precautions for use of reagents ........................................................................................................... 3-3

Control devices .................................................................................................................................... 3-4

Main function keys.......................................................................................................................... 3-4

The mouse keys ............................................................................................................................. 3-5

Main computer terminology ............................................................................................................ 3-5

Recommendation for use of the bar code reader ........................................................................... 3-6

Starting VIDAS PC............................................................................................................................... 3-7

Shutting down VIDAS PC .................................................................................................................. 3-10

Changing the system date and time................................................................................................... 3-13

User management ............................................................................................................................. 3-14

Creating a user .................................................................................................................................. 3-16

Modifying a user................................................................................................................................. 3-20

Deleting a user................................................................................................................................... 3-22

Unlocking a user account................................................................................................................... 3-24

Opening a session for a new user...................................................................................................... 3-25

Selecting a default printer .................................................................................................................. 3-26

Logging on with a user group after opening a session....................................................................... 3-27

Changing the password ..................................................................................................................... 3-29

Changing the password when opening Windows

®

....................................................................... 3-29

Changing the password when starting VIDAS PC........................................................................ 3-29

VIDAS

®

PC User's Manual V-1

Table of Contents

Locking and unlocking the VIDAS PC software ................................................................................. 3-30

Locking and unlocking the BCI RS232 software ................................................................................3-31

4 Instructions for use 4-1

Theory of operation .............................................................................................................................. 4-2

User interface....................................................................................................................................... 4-5

Presentation of the main screen..................................................................................................... 4-5

The navigation tree......................................................................................................................... 4-7

The three main menus.................................................................................................................... 4-7

The VIDAS PC status summaries .................................................................................................. 4-8

Calibration status ...................................................................................................................... 4-8

Instrument status ...................................................................................................................... 4-8

Section status ........................................................................................................................... 4-8

User identification........................................................................................................................... 4-9

Minimize button .............................................................................................................................. 4-9

Presentation of a typical menu ..................................................................................................... 4-10

Entering assays (or assay requests).................................................................................................. 4-11

Summary table for the different entries ........................................................................................ 4-13

Entry in simple demographics mode ............................................................................................ 4-14

Entry in complete demographics mode ........................................................................................4-15

Entry in "Industrial context" mode................................................................................................. 4-16

Modifying and deleting assay requests ........................................................................................ 4-17

Managing creation of predefined sections for two connected VIDAS

®

analytical modules........................................................................................................................ 4-17

Transferring assays............................................................................................................................ 4-18

Transferring an assay from the job list to a predefined section .................................................... 4-20

Manual transfer....................................................................................................................... 4-20

Optimized transfer .................................................................................................................. 4-21

Transferring assays from predefined sections to the job list......................................................... 4-21

Reserving sections............................................................................................................................. 4-22

Individual reservation.................................................................................................................... 4-24

Grouped reservation..................................................................................................................... 4-24

Manual reservation....................................................................................................................... 4-25

Printing.................................................................................................................................... 4-27

Running assays ................................................................................................................................. 4-29

Loading plan................................................................................................................................. 4-29

Load help screen .................................................................................................................... 4-31

Printing.................................................................................................................................... 4-32

Quitting the menu ................................................................................................................... 4-32

Running assays ...................................................................................................................... 4-33

Emergencies ...................................................................................................................................... 4-35

Reserving a section and running an assay................................................................................... 4-36

Modification - Deletion........................................................................................................................ 4-37

Modification of an assay............................................................................................................... 4-37

Deletion ........................................................................................................................................ 4-39

Deletion of an assay from the job list ...................................................................................... 4-40

Deletion of an assay in a predefined section .......................................................................... 4-41

Halting an assay ..................................................................................................................... 4-41

V-2 VIDAS

®

PC User's Manual

Table of Contents

5 Updating a VIDAS assay 5-1

Purpose of the PTC update ................................................................................................................. 5-2

Updating .............................................................................................................................................. 5-2

Preliminary instructions .................................................................................................................. 5-2

Reading PTC cards ........................................................................................................................ 5-3

6 Calibration 6-1

Calibration / recalibration ..................................................................................................................... 6-2

Calibrators...................................................................................................................................... 6-3

How to calibrate.............................................................................................................................. 6-3

Controls .................................................................................................................................... 6-8

MLE card (Master Lot Entry) or specifications sheet ...................................................................... 6-9

Presentation ............................................................................................................................. 6-9

Composition............................................................................................................................ 6-11

"Calibrations" menu ........................................................................................................................... 6-12

Entry of MLE card data................................................................................................................. 6-14

Automatic reading by the VIDAS analyzer.............................................................................. 6-14

Manual entry or entry using the bar code reader .................................................................... 6-16

Displaying Calibrations................................................................................................................. 6-18

Calibrations to do.................................................................................................................... 6-18

Current calibrations................................................................................................................. 6-20

All calibrations (valid and expired) .......................................................................................... 6-23

Deleting calibrations ..................................................................................................................... 6-24

Other recalibration methods............................................................................................................... 6-25

7 Results 7-1

Calculating results................................................................................................................................ 7-2

Qualitative assays..................................................................................................................... 7-2

Quantitative assays .................................................................................................................. 7-2

Results menu....................................................................................................................................... 7-3

"Results" menu commands ............................................................................................................ 7-5

Details of a result............................................................................................................................ 7-6

List of functions .............................................................................................................................. 7-8

Validate..................................................................................................................................... 7-8

Retest ....................................................................................................................................... 7-8

Recompute ............................................................................................................................... 7-8

Retransmit .............................................................................................................................. 7-10

Exporting results..................................................................................................................... 7-10

Print ........................................................................................................................................ 7-12

8 The different VIDAS PC menus 8-1

Functions ............................................................................................................................................. 8-2

Loading ................................................................................................................................................ 8-2

Results................................................................................................................................................. 8-2

Calibrations.......................................................................................................................................... 8-3

VIDAS

®

PC User's Manual V-3

Table of Contents

Quality control ...................................................................................................................................... 8-3

Kit quality control reports................................................................................................................ 8-5

Select data................................................................................................................................ 8-5

Display...................................................................................................................................... 8-7

External quality control report......................................................................................................... 8-8

Select data................................................................................................................................ 8-8

Display.................................................................................................................................... 8-10

Linearity report ............................................................................................................................. 8-14

Selecting data ......................................................................................................................... 8-14

Text mode display................................................................................................................... 8-15

Graphic mode display ............................................................................................................. 8-18

Patient data........................................................................................................................................ 8-19

"Patient data" menu commands ...................................................................................................8-21

Search procedure......................................................................................................................... 8-22

Procedure for patient search................................................................................................... 8-23

Printing of results .................................................................................................................... 8-24

Instrument .......................................................................................................................................... 8-26

Section status window.................................................................................................................. 8-28

Statuses.................................................................................................................................. 8-28

Managing sections.................................................................................................................. 8-28

Error window ................................................................................................................................8-30

List of errors............................................................................................................................ 8-31

Log..................................................................................................................................................... 8-38

Configuration...................................................................................................................................... 8-39

"Routine" submenu....................................................................................................................... 8-41

"Assay assignment" submenu ......................................................................................................8-43

"Profiles" submenu ....................................................................................................................... 8-45

Entering a profile of assays.................................................................................................... 8-46

"BCI" submenu ............................................................................................................................. 8-46

"Units" submenu........................................................................................................................... 8-46

"Assay activation" submenu ......................................................................................................... 8-48

"Controls" submenu...................................................................................................................... 8-49

The "Westgard" submenu............................................................................................................. 8-51

Specific assay set up .............................................................................................................. 8-53

Printing.................................................................................................................................... 8-53

Maintenance ...................................................................................................................................... 8-54

"About" dialog box............................................................................................................................. 8-54

9 Backup 9-1

Programming automatic backup .......................................................................................................... 9-2

Starting manual backup .......................................................................................................................9-5

Restoring data...................................................................................................................................... 9-7

V-4 VIDAS

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Table of Contents

10

Bidirectional Computer Interface (BCI) 10-1

Introduction ........................................................................................................................................ 10-2

BCI Configuration............................................................................................................................... 10-3

"Routine" submenu....................................................................................................................... 10-4

"BCI Link" submenu ..................................................................................................................... 10-6

Selecting the BCI RS232 link.................................................................................................. 10-6

Selecting the BCI NET link ................................................................................................... 10-10

BCI RS232 Configuration................................................................................................................. 10-11

Status of the connection ....................................................................................................... 10-12

Alarm connection.................................................................................................................. 10-12

Unused connection ............................................................................................................... 10-12

"Link Operations" submenu ........................................................................................................ 10-13

Starting/stopping the connection .......................................................................................... 10-14

Transmission of results (Upload) .......................................................................................... 10-14

Reception of requests (Download)........................................................................................ 10-14

Results on hold (Back in Service/Out of Service) ................................................................. 10-14

Displaying communications tracking data............................................................................. 10-15

Displaying uploaded messages ............................................................................................ 10-16

Searching for uploaded messages ....................................................................................... 10-17

Deleting uploaded messages ............................................................................................... 10-18

Printing uploaded messages ................................................................................................ 10-18

"Link Configuration" submenu .................................................................................................... 10-19

"Tools" submenu ........................................................................................................................ 10-20

Unidirectional interface .................................................................................................................... 10-21

BCI RS232 parameter setting .................................................................................................... 10-21

Starting/stopping the connection .......................................................................................... 10-21

Transmission of results (Upload) .......................................................................................... 10-21

Reception of requests (Download)........................................................................................ 10-21

Connection statuses ............................................................................................................. 10-21

Setting VIDAS PC parameters ................................................................................................... 10-22

Loading ...................................................................................................................................... 10-22

Automatic transmission of results............................................................................................... 10-23

Bidirectional connection ................................................................................................................... 10-24

Setting BCI RS232 parameters .................................................................................................. 10-24

Starting/stopping the connection .......................................................................................... 10-24

Transmission of results (Upload) .......................................................................................... 10-24

Reception of requests (Download)........................................................................................ 10-24

Connection statuses ............................................................................................................. 10-24

Setting VIDAS PC parameters ................................................................................................... 10-25

Loading ...................................................................................................................................... 10-26

Automatic transmission of results ......................................................................................... 10-26

Validation / Retransmission of results .............................................................................................. 10-27

"Results" Menu........................................................................................................................... 10-27

Displaying results ....................................................................................................................... 10-27

Validation of results .................................................................................................................... 10-27

Retransmission of results ........................................................................................................... 10-27

VIDAS

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PC User's Manual V-5

Table of Contents

11 Maintenance 11-1

Patient database purge ...................................................................................................................... 11-2

Maintenance "Instrument run"............................................................................................................ 11-7

12 Troubleshooting 12-1

Reagent errors ................................................................................................................................... 12-2

Instrument errors................................................................................................................................ 12-3

List of errors from 12 to 57 and corresponding corrective action.................................................. 12-4

List of errors from 101 to 163 .......................................................................................................12-8

List of errors from 101 to 163 and corresponding corrective action ...................................... 12-10

Software errors ................................................................................................................................12-16

Internal errors ............................................................................................................................. 12-17

Assay preparation and loading errors:........................................................................................ 12-17

"Results" window errors.............................................................................................................. 12-20

"Configuration" window errors .................................................................................................... 12-21

Errors or warnings printed on reports............................................................................................... 12-22

Error not related to the equipment ................................................................................................... 12-24

13 Glossary 13-1

14 Index 14-1

Notes

V-6 VIDAS

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List of figures

1 How to use this manual 1-1

2 Functional description 2-1

3 Getting started 3-1

Fig. III 1: VIDAS PC initialization screen .............................................................................................. 3-8

Fig. III 2: Main screen .......................................................................................................................... 3-9

Fig. III 3: Shutting down Windows

®

.................................................................................................... 3-11

Fig. III 4: Shutting down the computer ............................................................................................... 3-12

Fig. III 5: Date/Time Properties window ............................................................................................. 3-13

Fig. III 6: Opening the VIDAS user manager window......................................................................... 3-16

Fig. III 7: Add user window................................................................................................................. 3-17

Fig. III 8: Group membership window ................................................................................................ 3-18

Fig. III 9: Group membership window ................................................................................................ 3-20

Fig. III 10: Deleting a user account .................................................................................................... 3-22

Fig. III 11: Unlocking a user account.................................................................................................. 3-24

Fig. III 12: Selecting a printer ............................................................................................................. 3-26

Fig. III 13 : VIDAS PC login window.................................................................................................. 3-30

Fig. III 14 : BCI RS232 login window.................................................................................................. 3-31

4 Instructions for use 4-1

Fig. IV 1: Basic VIDAS workflow .......................................................................................................... 4-3

Fig. IV 2: Basic VIDAS workflow (cont’d) ............................................................................................. 4-4

Fig. IV 3: Main screen .......................................................................................................................... 4-5

Fig. IV 4: List of VIDAS PC menus....................................................................................................... 4-6

Fig. IV 5 : A typical menu ................................................................................................................... 4-10

Fig. IV 6: "Loading" window (complete demographics mode) ............................................................ 4-12

Fig. IV 7: Entry zone (simple demographics) .....................................................................................4-14

Fig. IV 8: Entry zone (complete demographics) ................................................................................. 4-15

Fig. IV 9: Entry zone (industrial context) ............................................................................................ 4-16

Fig. IV 10: Transfer to predefined sections ........................................................................................ 4-19

Fig. IV 11: Main reservation commands............................................................................................. 4-23

Fig. IV 12: Manual reservation window .............................................................................................. 4-25

Fig. IV 13: Job list report (example) ................................................................................................... 4-28

Fig. IV 14 : Predefined sections list report (example)......................................................................... 4-28

Fig. IV 15: Loading plan commands................................................................................................... 4-29

Fig. IV 16: Loading plan window ........................................................................................................ 4-30

VIDAS

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PC User's Manual VI-1

List of figures

Fig. IV 17: Loading report (example).................................................................................................. 4-32

Fig. IV 18: Section assigned to emergencies .....................................................................................4-35

Fig. IV 19: Modification of an assay ................................................................................................... 4-37

Fig. IV 20: Deletion of an assay ......................................................................................................... 4-39

5 Updating a VIDAS assay 5-1

Fig. V 1 : "Assay activation" function.................................................................................................... 5-3

Fig. V 2 : Assay update card reading screen .......................................................................................5-4

Fig. V 3 : Examples of bar codes ......................................................................................................... 5-4

Fig. V 4 : Status after reading of the first bar code (example).............................................................. 5-5

Fig. V 5 : Status after reading of the last bar code (example) .............................................................. 5-6

Fig. V 6 : Assay update report (example)............................................................................................. 5-7

6 Calibration 6-1

Fig. VI 1: Master curve......................................................................................................................... 6-5

Fig. VI 2: Establishing the master curve............................................................................................... 6-6

Fig. VI 3:Recalibration of the master curve .......................................................................................... 6-7

Fig. VI 4: MLE card (qualitative assays)............................................................................................... 6-9

Fig. VI 5: MLE card (quantitative assays)........................................................................................... 6-10

Fig. VI 6: Calibrations window (example)........................................................................................... 6-13

Fig. VI 7: Read MLE card window...................................................................................................... 6-14

Fig. VI 8: MLE Card report (example) ................................................................................................ 6-17

Fig. VI 9: "Calibrations to do" window ................................................................................................ 6-18

Fig. VI 10: "Valid calibrations" window ............................................................................................... 6-20

Fig. VI 11: Calibration details ............................................................................................................. 6-22

7 Results 7-1

Fig. VII 1: "Results" menu window ....................................................................................................... 7-4

Fig. VII 2: Example of results ............................................................................................................... 7-6

Fig. VII 3: Additional assay data........................................................................................................... 7-7

Fig. VII 4: "Recompute" submenu ........................................................................................................ 7-9

Fig. VII 5: Exporting data from the Results Menu............................................................................... 7-11

Fig. VII 6: Results report (list of results) ............................................................................................. 7-13

Fig. VII 7: Results reports (one result)................................................................................................ 7-13

8 The different VIDAS PC menus 8-1

Fig. VIII 1: "Quality control" menu window ...........................................................................................8-4

Fig. VIII 2: Window for the result of a kit quality control ....................................................................... 8-7

Fig. VIII 3: Window for the result of an external control (text mode)................................................... 8-11

Fig. VIII 4: Result of an external quality control (graphic mode)......................................................... 8-12

Fig. VIII 5: Expected concentrations .................................................................................................. 8-15

Fig. VIII 6: Result of a text mode linearity report ................................................................................ 8-16

Fig. VIII 7: Result of a linearity control (graphic mode).......................................................................8-18

VI-2 VIDAS

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List of figures

Fig. VIII 8: "Patient data" menu window............................................................................................. 8-20

Fig. VIII 9: Detailed patient data......................................................................................................... 8-22

Fig. VIII 10: Printing of results............................................................................................................ 8-25

Fig. VIII 11: "Instrument" menu status window...................................................................................8-27

Fig. VIII 12: Error display window....................................................................................................... 8-30

Fig. VIII 13: Online help window......................................................................................................... 8-32

Fig. VIII 14: "Log" menu window ........................................................................................................ 8-38

Fig. VIII 15: "Routine" submenu window ............................................................................................ 8-41

Fig. VIII 16: "Assay assignment" submenu window ........................................................................... 8-43

Fig. VIII 17: "Profiles" submenu window ............................................................................................ 8-45

Fig. VIII 18: "Units" submenu window ................................................................................................ 8-47

Fig. VIII 19: "Assay activation" submenu ........................................................................................... 8-48

Fig. VIII 20: "Controls" submenu window ........................................................................................... 8-49

Fig. VIII 21: "Westgard" submenu window .........................................................................................8-51

Fig. VIII 22: Specific set-up ................................................................................................................ 8-53

Fig. VIII 23: "About" menu window (example).................................................................................... 8-54

9 Backup 9-1

Fig. IX 1: Backup selection .................................................................................................................. 9-2

Fig. IX 2: Setting automatic backup parameters ..................................................................................9-3

Fig. IX 3: Maintenance menu (backup) ................................................................................................ 9-6

Fig. IX 4: Maintenance Menu (restore)................................................................................................. 9-8

10 Bidirectional Computer Interface (BCI) 10-1

Fig. X 1: "Routine" submenu.............................................................................................................. 10-4

Fig. X 2: "Link BCI" submenu - "BCI RS232" link.............................................................................. 10-6

Fig. X 3: Field selection zone............................................................................................................. 10-8

Fig. X 4: " Submenu BCI Link"–BCI NET Link.................................................................................. 10-10

Fig. X 5: "BCI RS232 Configuration" Menu...................................................................................... 10-11

Fig. X 6: BCI-NT Configuration: "Link Operations" submenu ........................................................... 10-13

Fig. X 7: Displaying communications tracking data.......................................................................... 10-15

Fig. X 8: Displaying uploaded messages ......................................................................................... 10-16

Fig. X 9: Search for transmitted messages ...................................................................................... 10-17

Fig. X 10: "Link Configuration" submenu ......................................................................................... 10-19

VIDAS

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PC User's Manual VI-3

List of figures

11

Maintenance 11-1

Fig. XI 1: "Run" window...................................................................................................................... 11-3

Fig. XI 2: VidasPurge selection window ............................................................................................. 11-4

Fig. XI 3: VidasPurge selection window ............................................................................................. 11-5

Fig. XI 4: Invalid password................................................................................................................. 11-5

Fig. XI 5: Purge confirmation window................................................................................................. 11-6

Fig. XI 6: End of VidasPurge.............................................................................................................. 11-6

Fig. XI 7: Maintenance Menu ............................................................................................................. 11-7

Fig. XI 8: Password for the "Instrument run" submenu....................................................................... 11-8

12 Troubleshooting 12-1

Fig. XII 1: Indication of an error (example)......................................................................................... 12-8

Fig. XII 2: Description of an error (example) ......................................................................................12-9

Note: The copies of VIDAS PC software screens are only given as examples.

VI-4 VIDAS

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PC User's Manual

1 How to use this manual

Introduction

This manual covers the procedures for the major functions of the VIDAS as well

as its software and consumables.

It also deals with the various procedures relating to the VIDAS installation and

start-up.

The instruments are described in the VIDAS Instrument User’s Manual.

CAUTION! The software must be used by trained personnel only, who are authorized

to do so.

You are advised to read and understand all the instructions in this manual

to be able to derive the best performance from your VIDAS.

VIDAS

®

PC User's Manual 1-1

How to use this manual

Finding topics and procedures

Finding topics and procedures

This manual is divided into fourteen chapters. The first eleven chapters are used

for the description and procedures. Chapter 13 contains the glossary and

chapter 14 the index.

Table of contents

The main table of contents of the manual is located on pages V-1 to V-6.

It lists each chapter and the procedures and/or topics contained in the chapter.

List of figures

Pages VI-1 to VI-3 contain 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.

Warnings

The warning messages are used throughout the procedures for use.

All the warnings in this manual should be read carefully before using VIDAS PC

in any way.

Page headers and

page footers

Apart from the first page of every chapter, each page of the manual includes a

page header and 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 13 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 14 at the back of the manual. It is used to locate

a particular description or procedure.

1-2 VIDAS

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PC User's Manual

How to use this manual

Typographic conventions

Typographic conventions

1

2

3

These conventions are used in the different chapters of the manual.

• Click on...

A bullet point is used to denote an action to be performed.

"Calibration…”

Quotation marks are used for information which appears on the screen:

messages, menu options, functions.

< >

Keyboard keys are represented in angle brackets.

"O" and "I" are letters.

"ø" and "1"

are the digits zero and one.

Warnings

The following warnings are used throughout the manual:

for safety reasons (DANGER!), −

−

−

to ensure that VIDAS is maintained in good working condition (CAUTION!),

or to allow optimum use of your VIDAS (IMPORTANT!).

4

5

VIDAS

®

PC User's Manual 1-3

How to use this manual

Graphic symbols

1-4 VIDAS

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PC User's Manual

Graphic symbols

4501-1582 A en

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)

How to use this manual

Graphic symbols

1

2

3

4

5

VIDAS

®

PC User's Manual 1-5

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

"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, consult accompanying documents

High temperature

Potential pinch point

Biological risks

Consult Instructions for Use

LOT

Batch code

REF

or REF

Catalogue number

Temperature limitation

EC REP

Authorised Representative in the European Community

How to use this manual

Graphic symbols

1-6 VIDAS

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PC User's Manual

Keep dry

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