Biomerieux Vidas PC User Manual

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Page 1

REF : 93 073

Version : F

05/2008

VIDAS® PC

User's Manual

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

Tel. 33 (0)4 78 87 20 00 - Fax 33 (0)4 78 87 20 90

4501-1714-en

http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

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4501-1584 E en

Argentina

bioMérieux Argentina

Av. Congreso 1745 (C1428BUE) Capital Federal Buenos Aires tel. (54) 11 5555-6800 fax (54) 11 5555-6888

Australia

bioMérieux Australia P/L

Unit 25, Parkview Business Center 1 Maitland Place Baulkham Hills NSW 2153 tel. (61) 2 8852 4700 fax (61) 2 8852 4777

Austria

bioMérieux Austria GmbH

Eduard-Kittenberger-Gasse 97 Top 3 A-1230 Wien tel. (43) 186 50 650 fax (43) 186 50 661

Belgium

bioMérieux Benelux s.a./n.v.

Media Square 18-19 Place des Carabiniers Bruxelles 1030 tel. (32) 2 743 01 70 fax (32) 2 733 55 97

Brazil

bioMérieux Brasil SA

Estrada Do Mapua 491 Taquara - Jacarepaguá CEP 22710 261 Rio de Janeiro R.J Rio de Janeiro R.J tel. (55) 21 2444 1400 fax (55) 21 2445 6025

Canada

bioMérieux Canada, Inc. 7815, Henri-Bourassa West Saint Laurent, QC H4S 1P7 tel. (1) 514 336 7321 fax (1) 514 807 0015

Chile

bioMérieux Chile S.A. Seminario 131 Providencia Santiago tel. (56) 2634 20 92 fax (56) 2634 20 93

China

bioMérieux China Limited

Room 1601-02B & 10 Est Ocean Centre n° 24A Jiang Guo Men Nei Street, 100004 Beijing tel. (86) 10 6515 6963 fax (86) 10 6515 6993

bioMérieux China Limited

Room 2605, South Tower, World Trade Center 371-375 Huan Shi Dong East Road 510095 Guangzhou tel. (86) 20 8762 7010 fax (86) 20 8762 7015

Colombia

bioMérieux Colombia Ltda Avenida 15 No. 100-43 Piso 2 Bogotá D.C. tel. (57) 1 520 0080 fax (57) 1 520 0088 / 1 520 0831

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 (420) 2 57 290 964

Denmark

bioMérieux Danmark Aps

Smedeholm 13C, 2730 Herlev tel. (45) 70 10 84 00 fax (45) 70 10 84 01

Finland

bioMérieux Suomi Oy Konalantie 47 C FI-00390 Helsinki tel. (358) 9 8545 6000 fax (358) 9 8545 6045

France

bioMérieux S.A. 69280 Marcy l’Etoile tel. 33 (0)4 78 87 20 00 fax 33 (0)4 78 87 20 90 http://www.biomerieux.com

Germany

bioMérieux Deutschland GmbH Weberstrasse 8 D-72622 Nürtingen tel. (49) 7022 30070 fax (49) 7022 36110

Greece

bioMérieux Hellas S.A.

Papanikoli 70 15232 Halandri Athens tel. (30) 210 81 72 400 fax (30) 210 68 00 880

Hungary

bioMérieux Hungária Kft.

Fóti út. 56 (5 H-1047 Budapest tel. (36) 1 231 3050 fax (36) 1 231 3059

India

bioMérieux India Pvt. Ltd

A-32, Mohan Co-Operative Ind. Estate New Delhi 110 024 tel. (91) 11 42 09 88 00 fax (91) 11 24 64 88 30

Indonesia Representation office

bioMérieux Indonesia

Enseval Building Kawasan Industri Pulo Gadung - JI. Pulo Lentut No. 10 Jakarta Timur 13920 tel. (62) 21 461 51 11 fax (62) 21 460 41 07

Italy

bioMérieux Italia S.p. A

Via Fiume Bianco, 56 00144 Roma tel. (39) 0 6 523081 fax (39) 0 6 52308240

Ivory Coast

bioMérieux Afrique Occidentale

08 BP 2634 Abidjan 08 tel. (225) 22 40 93 93 / (225) 22 40 41 40 fax (225) 22 40 93 94

Japan

bioMérieux Japan, Ltd

Seizan Bldg., 12-28 Kita-Ayoama 2-chome Minato-ku, Tokyo 107-0061 tel. (81) 3 5411 87 11 fax (81) 3 5411 87 10

Korea

bioMérieux Korea Co., Ltd

1 # 830-67 Yoksam-dong, Kangnam ku Seoul 135-080 tel. (82) 2 2188 4700 fax (82) 2 547 6263

& 2nd Floor, Yoosung Building

Floor)

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Mexico

bioMérieux México SA de CV

Chihuahua 88, col. Progreso México 01080, D.F. tel. (52) 55 5481 9550 fax (52) 55 5616 2245

Netherlands (The)

bioMérieux Benelux BV

Boseind 15 P.O. Box 23 5280 AA Boxtel tel. (31) 411 65 48 88 fax (31) 411 65 48 73

New Zealand

bioMérieux New Zealand Ltd

C/- Logical Freight Solutions 12 C Rennie Drive, Airport Oaks Auckland tel. (64) 9 918 6354 fax (64) 9 918 6355

Norway

bioMérieux Norge AS

∅kernveien 145 N - 0513 Oslo tel. (47) 23 37 55 50 fax (47) 23 37 55 51

Philippines (The) Representation office

bioMérieux Philippines Rep. Office

11th Floor, Pearlbank Centre 146 Valero Street, Salcedo Village 1227 Makati City tel. (632) 817 7741 fax (632) 812 0896

Poland

bioMérieux Polska Sp. Z.o.o. ul. Zeromskiego 17

01-882 Warsaw tel. (48) 22 569 85 00 fax (48) 22 569 85 54

Portugal

bioMérieux Portugal, Lda.

Av. 25 de Abril de 1974, nº 23 – 3º 2795-197-LINDA-A-VELHA tel. (351) 21 415 23 50 fax (351) 21 418 32 67

Russia

o.o.o. bioMérieux

Derbenevskaya ul. 20, str. 11 115 114 Moscow tel. (7) 495 221 10 79 fax (7) 495 221 10 79

Spain

bioMérieux España S.A. Manual Tovar, 45-47 28034 Madrid tel. (34) 91 358 11 42 fax (34) 91 358 06 29

Sweden

bioMérieux Sverige AB

Hantverksvägen 15 436 33 Askim tel. (46) 31 68 84 90 fax (46) 31 68 48 48

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc Case postale 2150 1211 Genève 2 tel. (41) 22 906 57 60 fax (41) 22 906 57 42

Taiwan Representation office

bioMérieux China Limited - Taiwan Branch

RM 608, No. 6-3 Ching Cheng Street Taipei 105 tel. (886) 2 2545 2250 fax (886) 2 2545 0959

Distribution in over 130 countries

Thaïland

bioMérieux Thaïland Ltd

Regent House Bldg, 16 th Floor 183 Rajdamri Road, Lumpini, Pathumwan Bangkok 10330 tel. (66) 2 651 98 00 fax (66) 2 651 98 01

Turkey

bioMérieux Diagnostik A.S.

Değirmen Sok. Nida Plaza Kat:6 34742 Kozyataği / Istanbul tel. (90) 216 444 00 83 fax (90) 216 373 16 63

United Kingdom

bioMérieux UK Ltd

Grafton Way, Basingstoke Hampshire RG22 6HY tel. (44) 1256 461881 fax (44) 1256 816863

USA

bioMérieux, Inc.

100 Rodolphe Street Durham NC 27712 tel. (1) 919 620 20 00 fax (1) 919 620 22 11

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. (84) 88 209 906 fax (84) 88 209 905

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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

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

IMPLIED PRODUCTS DESCRIBED IN THIS MANUAL WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE INFRINGEMENT OF THIRD PARTIES

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.

. IN ADDITION, THERE SHALL BE NO IMPLIED

, NOR NON

' INTELLECTUAL PROPERTY RIGHTS.

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.

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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.

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4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: VIDAS PC, BCI RS232 and/or BCI NET 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.

Release:

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.

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IV – Liability

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.

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.

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4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: VIDAS PC, BCI RS232 and/or BCI NET 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

Specifically, the User agrees not to decompile, reverse engineer or disassemble all or part of the Software.

Release:

II – Intellectual Property

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

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IV – Liability

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

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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 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.



SA recommends that you observe the different

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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

bearing the

symbol with regard to the waste electrical and electronic

to European countries and instruments

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.

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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

V.E. 12.005 New VIDAS software version All

V.F 05.2008 Addition of a backup mode Chapter 9

All

VIDAS

PC User's Manual Revisions-1

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Page 15

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

Page 16

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

Page 17

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

Page 18

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

PC User's Manual

Page 19

Table of Contents

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® PC User's Manual V-5

Page 20

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

PC User's Manual

Page 21

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® PC User's Manual VI-1

Page 22

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® PC User's Manual

Page 23

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® PC User's Manual VI-3

Page 24

List of figures

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® PC User's Manual

Page 25

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

Page 26

How to use this manual

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

List of figures

Graphic symbols

Warnings

Page headers and page footers

Glossary

Index

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.

Pages VI-1 to VI-3 contain a list of the figures in this manual.

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

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.

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.

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.

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® PC User's Manual

Page 27

How to use this manual

Typographic conventions

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

"Calibration…”

• Click on...

< >

"O" and "I" are letters.

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

Quotation marks are used for information which appears on the screen: messages, menu options, functions.

Keyboard keys are represented in angle brackets.

"ø" and "1"

Warnings

are the digits zero and one.

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!).

VIDAS

PC User's Manual 1-3

Page 28

How to use this 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)

1-4 VIDAS® PC User's Manual

Page 29

How to use this manual

Graphic symbols

"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

VIDAS

LOT

REF

EC REP

PC User's Manual 1-5

or REF

Consult Instructions for Use

Batch code

Catalogue number

Temperature limitation

Authorised Representative in the European Community

Page 30

How to use this manual

Graphic symbols

Keep dry

IVD

or SN

Manufacturer

Date of manufacture

In Vitro Diagnostic Medical Device

Serial number

Keep away from magnetic field

Separate collection for waste electrical and electronic equipment

1-6 VIDAS® PC User's Manual

Page 31

2 Functional description

Introduction

This chapter describes the main features of the VIDAS® PC software.

VIDAS

PC User's Manual 2-1

Page 32

Functional description

Description / Aim

The VIDAS software is multi-task.

It enables:

Entry of patient data and analyses via the keyboard or the bidirectional

−

connection with or without the bar code reader,

−

Printing of results via the printer, the screen or the uni/bidirectional connection (on request).

−

System operation and self-tests.

−

Management of calibrations and controls in memory.

−

Display and validation of results.

−

Management of patient records.

−

Running of one or two analytical modules.

The computer contains software programs and various files which enable it to run the VIDAS system.

VIDAS PC

software: This software contains all the elements and information required to run the

system.

Protocol software:

PTC Protocol Test Change: this software contains all the protocols and tests required

to perform assays.

Bidirectional Interface Software: BCI

idirectional Connection Interface: this is an optional software which controls

the bidirectional interface with the Laboratory Information System (LIS).

2-2 VIDAS

PC User's Manual

Page 33

Functional description

General features

Hardware

Consumables

Principle of operation

•

Refer to Chapter 2 of the VIDAS Instrument User's Manual in which the analytical and computer modules are described.

Refer to Chapter 2 of the VIDAS Instrument User's Manual in which the

•

consumables are described.

• Refer to Chapter 2 of the VIDAS Instrument User's Manual in which the

following are described:

− Methods for immunoassay.

− Protocol concept.

− The optical system.

VIDAS

PC User's Manual 2-3

Page 34

Page 35

3 Getting started

Introduction

This chapter covers the first steps you need to take before you can use the VIDAS PC :

safety instructions, −

−

precautions for use of reagents,

−

starting and shutting down the software,

−

defining and using user groups.

VIDAS

PC User's Manual 3-1

Page 36

Getting started

Safety instructions

This manual contains information and warnings which you must respect in order to ensure that the software runs properly.

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

provided by bioMérieux

If these instructions are not complied with, the computer and software provided by bioMérieux

could become infected with computer viruses.

Any intervention directly or indirectly resulting from the use of a software program other than the one provided by bioMérieux

shall not be covered

by the warranty or the maintenance contract.

Do not install a screen saver on the computer.

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

guidance of bioMérieux Technical Assistance.

The computer media containing the VIDAS PC software programs or the user’s backups used for installation or reinstallation, must be stored in an appropriate location.

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

3-2 VIDAS

PC User's Manual

Page 37

Getting started

Precautions for use of reagents

IMPORTANT! Reagent kits must be stored between 2 and 8°C.

Bring reagents to room temperature before use (refer to the package insert in the reagent kits).

To ensure that the standard duration of temperature control is respected, the strips should not be kept in the trays, or the SPR for any longer than it takes to prepare or normally perform the tests. Strips and SPRs should not be loaded into the instrument in advance, but just before the corresponding test is performed.

Do not use the reagents after the expiration date.

Do not mix reagents from different lots.

Carefully reseal the SPR pouch with the desiccant inside after use.

Powderless gloves should be worn when using the reagents.

Homogenize the standard, controls and samples before use.

Check that each SPR has a color-coded dot. If a SPR does not have its color-coded dot:

s in the SPR block,

VIDAS

−

Reject the result corresponding to the defective SPR.

−

Clean the SPR block.

−

Repeat the assay corresponding to the defective SPR.

−

Inform bioMérieux

PC User's Manual 3-3

Technical Assistance.

Page 38

Getting started

Control devices

You can access most of the VIDAS PC software functions using the mouse. However, you can also use the keyboard to run the software.

Main function keys

Ctrl

Num Lock

Delete

This key is always combined with another one (on the keyboard or on the mouse). Both keys should be pressed simultaneously.

(E.g.: <CTRL> + <left mouse button> enables you to select one or several lines on the screen).

Caps Lock key. This is used to lock the keyboard in upper case characters. Combined with the left mouse button, it allows you to select data lists in a table.

This key must be activated (light on) if you want to use the numeric keypad.

Left and right arrow keys are used for moving the cursor in the entry zones.

This key enables you to delete a character to the right of the cursor.

This key enables you to delete a character to the left of the cursor.

In certain windows, the tabulation key enables you to move the cursor from one entry field to another.

These function keys at the top of the keyboard correspond to keyboard shortcuts which are used in the "Loading" menu.

3-4 VIDAS

PC User's Manual

Page 39

Getting started

Control devices

The mouse keys

The left button is used for selecting.

The middle scroll wheel is used for rapid scrolling. The right button is not used in the VIDAS PC software.

Note: Left-handed users can invert the mouse buttons. To do so, please refer to the

Main computer terminology

Enable/disable boxes

enabled

Enabled/disabled icon

List zone

Entry zone

disabled

− Small boxes which correspond to one or several options which can be

enabled or disabled.

− Small circles corresponding to one or several options which can be enabled

or disabled. Only one option at a time can be enabled.

− When a function or a menu represented by an icon is accessible, the icon is

colored (enabled).

− When a function or a menu is not available, the icon is a bluish color

(disabled).

− In a dialog box, this zone lists available options. If all the options do not fit in

the zone, a scroll bar can be used.

− In a dialog box, this zone can be used to enter information.

Windows user's manual.

Text zone

VIDAS

PC User's Manual 3-5

− A zone in which you can enter information required to carry out a command.

When the dialog box opens, the text zone may be blank or already contain text.

Page 40

Getting started

Control devices

Recommendation for use of the bar code reader

To read a bar code:

•

Hold the reader about 5 cm from the bar code.

•

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

•

Depress the trigger.

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

•

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

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

When reading is complete:

•

Release the trigger.

If reading does not occur immediately:

•

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

•

If the problem persists, refer to Chapter 7 "Troubleshooting" of the VIDAS Instrument manual.

3-6 VIDAS

PC User's Manual

Page 41

Getting started

Starting VIDAS PC

•

Turn on the instruments in the following order:

− UPS (if necessary),

− VIDAS analytical modules,

− printer and screen,

− computer.

The configuration initializes.

•

Wait for the Windows® welcome window to appear.

•

Enter the user’s name and password.

Note: Your user name, your password and the user group you are a member of, must be pre-

defined in your laboratory.

This information will determine the level at which you can use your VIDAS PC software.

A user who is a member of the VIDAS_ADMIN group has access to all the software functions and certain administration functions such as programming backups, changing the system time etc.

A user who is a member of the VIDAS_ROUTINE group can access the main functions of the software, except the "Configuration" menu. The administration functions, however, are not available.

Group membership is predefined for each user by a bioMérieux engineer, the local bioMérieux representative or your laboratory system admininstrator.

Field Service

VIDAS

PC User's Manual 3-7

Page 42

Getting started

Starting VIDAS PC

The Windows

•

Wait for 2 minutes before starting the VIDAS PC application.

•

Double click on the VIDAS PC icon,

desktop is displayed.

The VIDAS PC initialization screen displays.

Fig. III 1: VIDAS PC initialization screen

3-8 VIDAS

PC User's Manual

Page 43

Getting started

Starting VIDAS PC

After a short time, the VIDAS PC main screen appears.

Fig. III 2: Main screen

Note: For optimum performance of the VIDAS PC software, only one application can be started

at a time. If you try to start a second application, the following error message appears.

VIDAS

• Click on "OK" to close the window.

PC User's Manual 3-9

Page 44

Getting started

Shutting down VIDAS PC

When you turn on the analytical module, leave it to warm up for 45 minutes.

When the analytical module initializes, it automatically calibrates according to a solid standard which reacts to temperature.

Note: If the room temperature is too low when the analytical module is turned on, an error is

generated (error 160) by VIDAS PC after the self-calibration phase (see "Error 160 – Selfcalibration drift", on page 12-15).

After the instrument has warmed up for 45 minutes, turn it off for one minute and then turn it back on again. This operation enables the instrument to store in memory the solid standard value after temperature stabilization.

Note: If error 160 was generated when the analytical module was turned on for the first time,

another error 160 will appear after the new self-calbiration phase. Turn off the module and then turn it back on again. If error 160 persists call your bioMérieux Service.

CAUTION! Never connect or disconnect cables when the computer is switched on.

Shutting down VIDAS PC

•

Make sure that:

− no assays are running,

− no reagents (strips and SPR

blocks,

− printing is not in progress.

To quit the VIDAS PC software,

•

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

The following dialog box displays.



Technical Assistance

s) remain in the strip sections and SPR

• Click on "Yes".

The Windows

3-10 VIDAS

desktop displays.

PC User's Manual

Page 45

Getting started

Shutting down VIDAS PC

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

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

Note: For more information on BCI RS232, see chapter "Bidirectional Computer Interface (BCI)"

in this manual.

For more information on BCI NET, see the BCI NET User’s Manual.

The Windows® desktop displays.

To shut down the computer,

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

screen or press one of the Windows key situated either side of the space bar.

• Select "Shut Down".

VIDAS

Fig. III 3: Shutting down Windows®

PC User's Manual 3-11

Page 46

Getting started

Shutting down VIDAS PC

Note: For optimum operation of your PC, it is recommended to shut it down once a week.

The following window appears.

Fig. III 4: Shutting down the computer

•

Select "Shut down"

•

Click "OK".

The computer will stop and shut down.

•

Turn off the other instruments:

− screen,

− printer,

− analytical module(s),

− UPS (if necessary).

3-12 VIDAS

PC User's Manual

Page 47

Getting started

Changing the system date and time

CAUTION! Incorrect setting of the date and time can lead to incorrect running of

programs and loss of data.

IMPORTANT! In order to change the system date and time, you must be logged on with a

user identifier which gives administration rights over the operating system. For additional information, contact your laboratory system administrator.

•

Go to the Windows® desktop.

•

Double click in the bottom right-hand corner of the window where the time is displayed.

The following dialog box appears :

VIDAS

Fig. III 5: Date/Time Properties window

•

Change the date and time.

•

Click "Apply ".

•

Click "OK".

The new date and time are displayed in the bottom right-hand corner of the Windows

PC User's Manual 3-13

desktop.

Page 48

Getting started

User management

The "User Manager" utility developed by bioMérieux® SA enables the laboratory administrator to:

− manage user accounts for Windows

− create and manage new user accounts.

XPe, VIDAS PC and BCI RS232 or

BCI NET created with previous versions of the VIDAS PC software;

Note: User management operations can only be performed by the laboratory system

administrator or another person qualified to do so.

The following table presents the user groups and their rights for for Windows XPe, VIDAS PC and BCI RS232 or BCI NET.

GROUP WINDOWS

Users

Administrators

VIDAS_ROUTINE

VIDAS_ADMIN

BCI_ROUTINE

BCI_ADMIN

ORDINARY / /

FULL / /

/ ORDINARY /

/ FULL /

/ / ORDINARY

/ / FULL

VIDAS PC

The "Users" group can use Windows XPe, but not modify its properties.

The "Administrators" group gives full access rights to the Windows software.

The "VIDAS_ROUTINE" group gives access rights to the main VIDAS PC menus, except the "Configuration" menu and the Maintenance/Instrument run menu.

The "VIDAS_ADMIN" group gives full access rights to all the VIDAS PC software menus

except the Maintenance/Instrument run menu.

The BCI_ROUTINE group allows you to view the BCI.

The "BCI_ADMIN" and "BCI_ROUTIN" groups give full access rights to the BCI RS232 or BCI NET software menus.

BCI RS232 or

BCI NET

3-14 VIDAS

PC User's Manual

Page 49

Getting started

User management

Example: To have full access rights to Windows® XPe, VIDAS PC and BCI RS232 or BCI NET, you

IMPORTANT! Each user must belong to a VIDAS group (VIDAS_ADMIN or

must be a member of the "Administrators", "VIDAS_ADMIN" and "BCI_ADMIN" and "BCI ROUTINE" groups.

To have limited access rights to Windows XPe but full access rights to VIDAS PC and BCI RS232 or BCI NET, you must be a member of the "Users", "VIDAS_ADMIN" and "BCI_ADMIN" and "BCI ROUTINE" groups.

To have limited access rights to Windows XPe, VIDAS PC and BCI RS232 or BCI NET, you must be a member of the "Users", "VIDAS_ROUTINE" and "BCI_ROUTINE" groups.

VIDAS_ROUTINE) and a Windows XPe group (Users or Administrators) to be able to use the VIDAS PC software.

If a bidirectional connection interface is used, each user must belong to a BCI group ("BCI_ADMIN" or "BCI_ROUTINE") to be able to use BCI RS232 or BCI NET.

VIDAS

PC User's Manual 3-15

Page 50

Getting started

Creating a user

Note: During user management, you must close the VIDAS PC interface.

• If necessary, open the session using the administrator's identifier and

On the Windows

• Double click on the "User Manager" icon.

The "Vidas user manager" menu opens and the following window is displayed.

password.

desktop:

Fig. III 6: Opening the VIDAS user manager window

To create a new user account,

• Click on "Add".

3-16 VIDAS

PC User's Manual

Page 51

Getting started

Creating a user

The following window displays:

•

Enter the user's name in the "Name" text box.

•

Enter the password in the "Password" text box.

•

Confirm the password in the corresponding text box.

•

Click on "OK" to confirm creation of the new user account.

Fig. III 7: Add user window

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PC User's Manual 3-17

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Getting started

Creating a user

The following window displays:

Fig. III 8: Group membership window

The name of the new user account is displayed at the top of the "Vidas user manager" window.

•

Select the user group(s) (Users, Administrators, VIDAS_ADMIN, VIDAS_ROUTINE, BCI_ADMIN, BCI_ROUTINE) in the "Groups" field according to the permissions or rights assigned to the new user.

•

Click on the button to assign permissions or rights, or on the button to remove them.

Note: A user can belong to several user groups, for example:

- VIDAS_ADMIN and BCI_ADMIN.

- VIDAS_ROUTINE and BCI_ROUTINE.

•

Proceed in the same way to create other user accounts.

•

Click on "Quit" to close the "Vidas user manager" window.

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Getting started

Creating a user

The following dialog box opens:

• Click on "Yes" to confirm creation of the new user account.

Note: A new user must be assigned a default printer (see section Selecting a default printer, on

page 3-26).

For a new user opening Windows XPe for a new user, on page 3-25.

for the first time, see section Opening a session

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Getting started

Modifying a user

Note: During user management operations, you must close the VIDAS PC interface.

• Open a session by entering the administrator's identifier and password (if

On the Windows

• Double click on the "User Manager" icon.

The "Vidas user manager" menu opens and the following window is displayed.

necessary).

desktop:

Fig. III 9: Group membership window

In the "Vidas user manager" window,

• Select the user whose rights you want to modify.

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Getting started

Modifying a user

In the "Groups" field,

Select the group to be removed or added using the add button or the

•

remove button

• Click on "Quit" when modification is finished.

The following window is displayed.

• Click on "Yes" to confirm the modifications.

The user's permissions and rights are now modified.

VIDAS

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Getting started

Deleting a user

Note: During user management operations, you must close the VIDAS PC interface.

• Open a session by entering the administrator's identifier and password (if

necessary).

On the Windows

desktop:

• Double click on the "User Manager" icon.

The " Vidas user manager" menu opens and the following window is displayed.

Fig. III 10: Deleting a user account

•

Select the user you want to delete in the list of users.

•

Click on "Delete".

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Getting started

Deleting a user

The following window is displayed.

•

Click on "Yes" to confirm deletion.

The user account is definitively deleted.

•

Click on "Quit" to close the "Vidas user manager" window.

Note: This operation has no effect on the results or calibrations that the user obtained in the

application. When the user is deleted, the user data remain in the VIDAS PC database and can be consulted by any other users who have access rights to this information.

VIDAS

PC User's Manual 3-23

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Getting started

Unlocking a user account

After three unsuccessful attempts to connect, the software will lock.

To unlock it:

• Open a session by entering the administrator's identifier and password.

On the Windows

• Double click on the "User Manager" icon.

The "Vidas user manager" menu opens and the following window is displayed.

desktop:

Fig. III 11: Unlocking a user account

•

Select the user account you want to unlock.

The "Unlock" button is activated.

•

Click on "Unlock" to unlock the account.

•

Click on "Quit" to close the "Vidas user manager" window.

The user account is now unlocked.

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Getting started

Opening a session for a new user

When Windows appear for modification of the password.

•

Click on OK.

A dialog box is displayed.

•

Enter your new password.

•

Confirm your new password.

•

Click on "OK".

A message is displayed informing you that your password has been changed.

•

Validate by clicking on "OK".

The Windows session opens.

Note: The numeric keypad is disabled when a new session is opened. Press

XPe is opened for the first time by a new user, various screens

Verr num

to enable it.

VIDAS

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Getting started

Selecting a default printer

When a new user account is created, the administrator must select a printer using Windows

Xpe. To do so, on the Windows desktop:

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

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

• Select "Settings" and then "Printers and Faxes".

Fig. III 12: Selecting a printer

In the "Printers and Faxes" menu,

•

Click on the icon of the printer to be selected by default.

•

Click on the right mouse button and select "Set as default printer".

This printer will be selected by default for the user's print-outs.

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Getting started

Logging on with a user group after opening a session

To log on using a different user group ("Routine" or "Administrator") to the one you initially logged on to the VIDAS PC software with, you have to quit the

CAUTION! • If you need to open a new Windows session, you must shut down the

VIDAS PC software and open a Windows® session using your own user

identifier .

connection and quit the BCI software before closing the current Windows session.

Proceed as follows:

click on the button in the bottom left-hand corner of the screen or press one of the "Windows" key situated either side of the space bar.

• select "Log Off…".

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Getting started

Logging on with a user group after opening a session

The "Log Off Windows" dialog box displays.

•

Select "Log off" .

The session closes and a new session opening screen is displayed.

•

Enter the data required to open a new Windows® session corresponding to the desired user group.

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Getting started

Changing the password

Changing the password when opening Windows®

Changing the password when starting VIDAS PC

When you enter your password, a dialog box will inform you if your password has expired.

•

Click on "OK".

A dialog box displays.

•

Enter your new password.

•

Confirm your new password.

•

Click on "OK".

A message will appear to inform you that your password has been changed.

When you enter your password in the VIDAS PC prompt screen, a dialog box will inform you if your password has expired.

•

Click on "OK".

•

Simultaneously press <Ctrl>, <Alt> and <Del>.

The Windows security window displays.

VIDAS

•

Click on "Change password".

•

Enter your old password.

•

Enter your new password.

•

Confirm your new password.

•

Click on "OK".

You can also change your password at any time using the above procedure.

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Getting started

Locking and unlocking the VIDAS PC software

After 30 minutes of inactivity, or if requested by the user (by clicking on the key icon in the bottom right-hand corner of the screen), the VIDAS PC software locks. This has no effect on assays in progress.

Note: The default time is 30 minutes, but it can be modified by any user who has sufficient rights

to access the "Routine" submenu in the "Configuration" screen.

The following window is displayed on the screen:

Fig. III 13 : VIDAS PC login window

To unlock the software,

•

Enter your user name.

•

Enter your password.

•

Click on "Login".

When you unlock the software, you can also log on as a different user but from the same group, i.e. "Routine" or "Administrator".

To do so,

•

Enter your user name.

•

Enter your password.

•

Click on "Login".

When you unlock the software, you can also log on as a different user but from another group. Refer to "Logging on with a user group after opening a session" on page 3-27.

CAUTION!

3-30 VIDAS

After 3 unsuccessful attempts, the software will lock. To unlock it, call your laboratory system administrator.

PC User's Manual

Page 65

Getting started

Locking and unlocking the BCI RS232 software

CAUTION!

To log on as a different user, you must be a member of the same user group ("Routine" or "Administrator"). If this is not the case, a warning message will appear on the screen. You will therefore have to quit the VIDAS PC software and open a Windows identifier.

If you need to open a new Windows session, you must shut down the connection and quit the BCI RS232 software before closing the current Windows session.

session using your own user

Locking and unlocking the BCI RS232 software

After 10 minutes of inactivity, the BCI RS232 software locks. This has no effect on the assays or the interface with the LIS.

The following window appears on the screen:

VIDAS

Fig. III 14 : BCI RS232 login window

To unlock the software,

•

Enter your password.

•

Click on "OK".

When you unlock the software, you can also log on as a different user but from the same group, i.e. "Routine" or "Administrator".

To do so,

•

Enter your user name.

•

Enter your password.

•

Click on "OK".

CAUTION!

If you need to open a new Windows session, you must shut down the connection and quit the BCI RS232 software before closing the current Windows

session.

Note: For the BCI NET software, see the BCI NET User’s Manual.

PC User's Manual 3-31

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Page 67

4 Instructions for use

Introduction

This chapter deals with the use of the VIDAS® PC software for preparing and starting assays.

VIDAS® PC User's Manual 4-1

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Instructions for use

Theory of operation

VIDAS is a multiparametric system for immunoassay. It is composed of hardware, software and consumables.

The VIDAS analytical module is divided into 5 sections each containing up to

−

6 assays with compatible protocols.

−

The VIDAS PC software can manage two VIDAS modules.

−

The reagent kits of 60, 30 or 10 tests are composed of:

− the reagent strips and SPR

− the necessary additional consumables such as standard(s), control(s),

diluent,

− the master curve in the form of bar codes (MLE card),

− the package insert.

The theory of operation on VIDAS consists of:

−

creating predefined sections,

−

running assays,

−

performing calibrations and controls.

s (Solid Phase Receptacle),

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Instructions for use

Theory of operation

Step 1 Prepare the sample

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

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

Step 4 Place the SPR

s in their slots.

Step 3 Fill the sample well

Step 6 Close the door of the SPR

block.

Step 7 Lower the section's cover.

Fig. IV 1: Basic VIDAS workflow

(continued on next page)

VIDAS® PC User's Manual 4-3

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Instructions for use

Theory of operation

Step 8 Run assays.

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

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

IMPORTANT! Always observe good laboratory practices and universal safety

precautions when handling VIDAS reagents.

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

CAUTION!

Check that each SPR® has a color-coded dot. If a SPR

−

does not have its color-coded dot :

Reject the result corresponding to the defective SPR

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

SPR

seal and if it has, then remove it.

Repeat the assay corresponding to the defective SPR

Inform bioMérieux® Technical Assistance.

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Instructions for use

User interface

Presentation of the main screen

When you start the VIDAS PC software, the following window displays:

1. Navigation tree

2. Three main menus

3. VIDAS status summary

Fig. IV 3: Main screen

VIDAS® PC User's Manual 4-5

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Instructions for use

User interface

The main window is divided into two parts:

the navigation tree and the three main menus, −

− the VIDAS PC status summaries.

• Click on the navigation tree in the main window to display the list of

VIDAS PC menus. The following window appears :

Fig. IV 4: List of VIDAS PC menus

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Instructions for use

User interface

The navigation tree

You can access 10 menus through this window :

− LOADING menu

The three main menus

Loading menu

− RESULTS menu

− CALIBRATIONS menu

− QUALITY CONTROL menu

− PATIENT DATA menu

− INSTRUMENT menu

− JOURNAL menu

− CONFIGURATION menu

− MAINTENANCE menu

− ABOUT menu

Enables you to prepare and run assays.

Calibrations menu

VIDAS® PC User's Manual 4-7

Results menu

Enables you to display and access the various procedures for calibration.

Enables you to display and validate assay results.

Page 74

Instructions for use

User interface

The VIDAS PC status summaries

Calibration status

Recently expired

calibrations

Instrument status

Analytical module

affected by the error

Section status

Enables you to view the status of the various sections.

The statuses are the following:

The flashing icon in the bottom left-hand corner of the screen indicates that at least one calibration has expired (see page 6-18).

Instrument error 101 to 163 : the icon corresponding to the analytical module affected by the error is circled in red (see page 12-8).

(white)

(green)

(white)

(red)

(black)

The section is available.

The section is reserved for emergencies.

The section has been reserved for a predefined section (see Reserving sections page 4-22).

Verifications are in progress in this section (reading of bar codes, strips, verification of calibrations, etc.). The section number is displayed below the section concerned, under the status bar.

The section is running an assay. The time indicated corresponds to the time of completion of the assay.

Strips and SPR

The section is being reset.

An error has occurred in a section.

The section is disconnected.

s are waiting to be unloaded from the section.

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Instructions for use

User interface

User identification

The identification icon shown opposite gives access to the VIDAS PC login window (see Fig. III 13). The user name is displayed below the icon.

To lock the VIDAS PC software,

•

Click on the identification icon.

The VIDAS PC login window displays. The VIDAS PC software is now locked. Assays continue normally.

It is possible to enter a user name and a password that are different to those initially entered.

This can be useful when several users work routinely with the VIDAS.

•

Enter the desired user name.

•

Enter the corresponding password.

•

Click on OK.

CAUTION!

Minimize button

The new user name is displayed below the icon.

To log on as a different user, you must be a member of the same user group ("VIDAS_ROUTINE" or "VIDAS_ADMIN"). If this is not the case, a warning message will appear on the screen. You will therefore have to quit the VIDAS PC software and open a Windows user name.

This button in the top right-hand corner of the window enables you to minimize a window to the size of an icon in the task bar.

To restore the window,

session using your own

• click on the icon in the task bar.

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Instructions for use

User interface

Presentation of a typical menu

All the VIDAS PC menu and submenu screens are divided into several zones with a similar architecture.

1. Menu bar. The menu bar enables you to access the three main menus

(Loading, Calibrations and Results) and to return to the main menu. The icon of the current menu is shaded.

2. Menu name. The name of the current menu or submenu is displayed.

3. Tool bar. The tool bar enables you to access the specific tools for the

current menu or submenu.

4. Menu screen. This is the specific screen for the current menu or submenu.

5. Sub-menu bar. The submenu bar enables you to access the different

submenus of the current menu.

6. Status bar. The status summary indicates the following information:

- section status,

- presence of errors,

- system time,

- name of the technician currently using the software.

Fig. IV 5 : A typical menu

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Instructions for use

Entering assays (or assay requests)

In the main window, or any other window,

or,

• Click on the "Loading" button,

in the main window,

•

click on the navigation tree and then,

•

select the "Loading" button.

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Instructions for use

Entering assays (or assay requests)

The following window is displayed.

1. Job list. List of entered assays waiting to be run, and assay requests

received from the LIS.

2. Predefined sections. List of the predefined sections waiting to be reserved

and then started.

3. Entry zone. Entry of data according to the entry mode selected (simplified,

complete, industrial). The fields of this zone are detailed in each entry mode.

4. Section number. The number of a predefined section is displayed below

the reserved section to which it corresponds.

5. Clear. The "Clear" button enables you to delete all the fields (including

the "Dilution" field).

by default, to 1. You can also press <F12> to do so (keyboard shortcut).

When you do this, the "Multiplier" check box returns,

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

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Instructions for use

Entering assays (or assay requests)

Before entering assays, you can select one of the following three entry modes:

−

simple demographics mode (see page 4-14).

−

complete demographics mode (see page 4-15).

−

industrial context mode (see page 4-16).

Summary table for the different entries

The selection of these modes is described in Chapter 8 - The different VIDAS PC menus.

Description of fields

(Maximum number of characters)

Assay code (obligatory field)

Dilution (3 characters)

Sample ID (12 characters - obligatory field)

Origin (5 characters)

Patient ID (12 characters)*

Patient’s name (30 characters)

Patient’s sex

Patient’s date of birth

Specimen*

Transfer mode ("Reserve" box to be enabled)

* This ID must be unique and specific for a patient or a specimen.

Simple

demographics

Yes Yes Yes

Depending on

type of assay

Yes Yes Yes

No Yes No

No No Yes

Depending on

work method

Complete

demographics

Depending on

type of assay

Depending on

work method

Industrial

context

Depending on

type of assay

Depending on

work method

VIDAS® PC User's Manual 4-13

Page 80

Instructions for use

Entering assays (or assay requests)

Entry in simple demographics mode

1. Assay selection. Manual entry or selection of an assay code from a pull-

down entry list.

2. Sample ID. Sample ID (12 characters maximum).

3. Dilution. Dilution factor for a defined assay. This window is only for

quantitative assay codes (from 1 to 999).

4. Origin. Five characters indicating the origin of the assay (laboratory,

specimen location, etc).

5. Multiplier. Enables you to repeat an assay up to 30 times.

6. Reserve. 2 work modes :

"Reserve" box enabled This enables automatic recording of an assay in a predefined section. "Reserve" box disabled: This enables automatic recording of an assay in the job list.

7. Create. The "Create" button enables you to validate entry of an assay. You

can also press <F10> to do so (keyboard shortcut).

8. Modify. The "Modify" button enables you to modify an entry in the job list or

a predefined section (see Modification - Deletion page 4-37). You can also press <F11> to do so (keyboard shortcut).

9. Clear. The "Clear" button enables you to delete all the fields (including the

"Dilution" field). By default the "Multiplier" check box resets to 1 when this is done. You can also press <F12> to do so (keyboard shortcut).

7 8

Fig. IV 7: Entry zone (simple demographics)

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Instructions for use

Entering assays (or assay requests)

To enter an assay request,

•

Select the assay.

•

Enter the necessary information in the entry zone according to the patient data.

•

Click on "Create" or press <F10> (keyboard shorcut).

The assay request is displayed as a list or predefined section, depending on the recording mode selected ("Reserve" box enabled or disabled).

Note: The cursor for entering the next assay request is automatically positioned in the "Sample

ID" text box.

Entry in complete demographics mode

1. Date of birth. Patient’s date of birth (depending on the configuration:

dd/mm/yyyy or mm/dd/yyyy).

2. Sex. Patient’s sex (M, F, -).

3. Patient name. Patient’s name (max. 30 characters). The patient’s name

will only be taken into account if a Patient ID has also been entered.

4. Patient ID. Patient ID (max. 12 characters).

Fig. IV 8: Entry zone (complete demographics)

To enter an assay request,

•

Select the assay.

•

Enter the necessary information in the entry zone according to the patient data.

VIDAS® PC User's Manual 4-15

Note: If a patient ID has previously been used, the patient’s data will appear by default.

See "Entry in simple demographics mode" on page 4-14 for entry of basic information.

•

Click on "Create" or press <F10> (keyboard shortcut).

The assay request is displayed as a job list or predefined section, depending on the recording mode selected ("Reserve" box enabled or disabled).

Page 82

Instructions for use

Entering assays (or assay requests)

Entry in "Industrial context" mode

1. Specimen. Specimen type (max. 30 characters).

To enter an assay request,

•

Select the assay.

•

Enter the necessary information in the entry zone.

See "Entry in simple demographics mode" on page 4-14 for entry of basic information.

•

Click on "Create" (or press <F10>.).

The assay request is displayed as a job list or a predefined section, depending on the recording mode selected ("Reserve" box enabled or disabled).

Fig. IV 9: Entry zone (industrial context)

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Instructions for use

Entering assays (or assay requests)

Modifying and deleting assay requests

The methods for modification and deletion of assay requests which have been entered and queued are described in "Modification - Deletion" on page 4-37.

Managing creation of predefined sections for two connected VIDAS® analytical modules

− If compatible assays have been assigned to different VIDAS® analytical

modules (VIDAS 1, VIDAS 2 in the Configuration menu) during the creation of an analysis including these assays, separate predefined sections are automatically created.

− The "Reorganize all sections by compatible tests" icon does not allow

you to group these tests together in one section.

VIDAS® PC User's Manual 4-17

Page 84

Instructions for use

Transferring assays

The following window shows assays and indicates the commands used to transfer them to a predefined section or the job list.

1. List of predefined sections. List of the predefined sections ready to be

reserved or run by the VIDAS module(s) (up to 20 predefined sections displayed at the same time).

2. One predefined section. Predefined section composed of a maximum of 6

assays with compatible protocols. The VIDAS PC software assigns a number to the predefined section and displays the expected time for completion of the assay.

3. Job list. The job list is composed of up to 200 lines. Each line is a request

for a given assay. You can sort by category by clicking on the column header (eg : Patient ID). The width of the columns can be adjusted. To do so,

Click on the ↔ arrows of the column header while holding down the left

•

button of the mouse until you obtain the width you want.

4. Selection of compatible assays. Selection of the first 6 compatible assays

in the job list. They will display in inverse video.

5. Entry commands for loading assays. Entry commands required to load

assays in a predefined section or the job list.

Note: It is possible to automatically perform a search for identical sample numbers in the job list.

To do so, use the bar code reader to scan a tube bar code corresponding to the sample number you are searching for.

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Instructions for use

Transferring assays

Fig. IV 10: Transfer to predefined sections

VIDAS® PC User's Manual 4-19

Page 86

Instructions for use

Transferring assays

Transferring an assay from the job list to a predefined section

Transfer of assay requests can be manual or optimized.

Manual transfer

Creating a predefined section in manual mode

• Select an assay in the job list (the assay is in inverse video).

• Transfer the assay by clicking on the "Transfer" button.

The assay appears in a predefined section numbered by VIDAS PC (if the "Manual assignment" box has not been selected).

If a predefined section has already been created for the same protocol, the assays will automatically be assigned to this section until all six positions have been filled.

If you want to transfer an assay to a predefined section of your choice, select the "Manual assignment" box beforehand.

If the "Manual assignment" box has been selected, a dialog box is displayed which will enable you to either use a new section or select the predefined section to which you want to transfer the assay.

The time required to run the assay (in minutes) is displayed below the number of the predefined section.

An assay that is transferred to a predefined section will disappear from the job list.

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Instructions for use

Transferring assays

Optimized transfer

Optimized transfer enables you to rapidly fill the positions of predefined sections by selecting the first six assay requests with compatible protocols from the job list.

This function can only be used if assays with compatible protocols have been assigned to the same VIDAS module (see "Assay assignment" submenu on page 8-43).

The "Select 6 compatible assays" button is enabled (colored).

The selected assays appear in the job list in inverse video.

• Click on this button.

• Transfer them to the predefined section by clicking on the "Transfer" button.

Note: If two assays with compatible protocols are assigned to two different VIDAS instruments,

two predfined lists will be created.

Transferring assays from predefined sections to the job list

Transferring an assay

• In the predefined section to be modified, select the assay you want to

transfer (the assay is displayed on a blue background).

• Click on the "Transfer" button.

The assay disappears from the predefined section and is returned to the top of the job list.

Sorting is possible by clicking on the column header.

Transferring a predefined section

• Select the predefined section by clicking in the white background of the

predefined section button.

The assays and the predefined section appear on a blue background.

• Click on the "Transfer" button.

VIDAS® PC User's Manual 4-21

All the assays loaded in this predefined section are returned to the top of the job list and the predefined section is cancelled.

Page 88

Instructions for use

Reserving sections

Reserving a section consists of loading a previously created predefined section in a section defined by VIDAS PC or the user.

You must then physically load the strips, SPR indicated on the loading plan provided by VIDAS PC. The instrument will then run the assays.

Two types of reservations are possible:

by VIDAS PC : −

− individual reservation

− grouped reservation

−

by the user:

− manual reservation

s and samples into the sections

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Instructions for use

Reserving sections

The window of the "Loading" menu displays the various functions used for the reservation of sections.

1. Individual reservation.

2. Grouped reservation.

3. Manual reservation.

Fig. IV 11: Main reservation commands

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Page 90

Instructions for use

Reserving sections

Individual reservation

VIDAS PC automatically assigns a predefined section to an available section.

Individual reservation is performed section by section.

• Click on the predefined section number.

The number is displayed in red.

Grouped reservation

The status of one of the sections of the VIDAS which is still available changes to reserved in the status bar.

When all the sections of each VIDAS module are loaded, you can no longer reserve sections.

A warning message alerts you when the VIDAS module is full (or modules if there are several).

Grouped reservation is managed by VIDAS PC. This procedure enables you to load all the predefined sections into the available sections of each VIDAS module in numerical order (except the sections dedicated to emergencies "EMERG." (see "Emergencies" on page 4-35).

• Click on the "Reserve all" button.

Note: Individual and grouped reservations take into account the assignment of assays by

module (see the "Assay assignment" submenu on page 8-43).

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Instructions for use

Reserving sections

Manual reservation

To perform manual reservation, proceed as follows:

The "Section reservation" window appears.

• Click on an "AVAIL" or "EMERG." button corresponding to the desired

section (the "Emergency" mode is described on page 4-35).

1. The section reservation window displays the number of the VIDAS

analytical module and the selected section.

Fig. IV 12: Manual reservation window

VIDAS® PC User's Manual 4-25

Page 92

Instructions for use

Reserving sections

• In the "Section reservation" window, click on the number of the predefined

section to be reserved.

The technician’s name is displayed.

• Click on the "Reserve" button if you only want to reserve a section (the

"Section reservation" window disappears).

The section status changes to "RESER", or,

• Click on the "Start immediately" button if you want to reserve a section and

run it immediately (the "Section reservation" window disappears).

Note: Check that reagents and samples have been inserted before starting the

assay.

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Instructions for use

Reserving sections

Printing

It is possible at any time to print information on assays and predefined sections.

The following window appears:

Note: If you select "Job list and predef. sections list" the 2 reports are printed one after another.

• Click on the "Print" button.

• Click on "Cancel" to close the window without printing,

• Select the option you want and click on "OK".

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Instructions for use

Reserving sections

Pending VIDAS patients

Patient ID

----------------MIL849

MOR564

Total number of pending assays : 6

Test

------RSV

TXG TXG TXG TXG TXG

Dilution

--------- 127848

Pending patients tests on Aug 02 2005 13:56:19

Sample ID

--------------

123564 C2 C1 S1 S1

Origin

-------C

Name

-------MILLER

MORTON

Fig. IV 13: Job list report (example)

Predefined sections

16 juil. 2005 18:55:23

Section Position Test Dilution Patient ID Sample ID

---------- ------------ ------ ---------- ------------- ------------------ 107 1 RSV MIL849 127848 2 TXG MOR564 123564 3 TXG C2 4 TXG C1 5 TXG S1 6 TXG S1

Section Position Test Dilution Patient ID Sample ID

---------- ------------ ------ ---------- ------------- ------------------ 108 1 OPT OPT 2 OPT OPT

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

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Instructions for use

Running assays

The assay is performed from start to finish by VIDAS PC.

Loading plan

Loading is made easier by the loading plan provided by VIDAS PC.

The following procedures were defined for one or two VIDAS modules.

You can access the VIDAS PC loading plan by clicking on one of the icons shown in the figure below.

1. Loading plan. These icons enable you to access the loading plan for

module 1 or module 2 before the start up phase.

Fig. IV 15: Loading plan commands

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Instructions for use

Running assays

Note: If two VIDAS modules are used, assays can be assigned specifically to one or another of

the modules (see "Assay assignment" page 8-43).

• Click on the "Access to loading plan" icon on the VIDAS 1 module,

• Click on the "Access to loading plan" icon on the VIDAS 2 module.

Note: If only one VIDAS module is connected, the button giving access to the loading plan of the

other module is disabled (blue).

The loading plan window appears.

1. Load help zone. Enables you to find an assay which has been reserved or

is being run, by searching for the patient ID or the sample ID.

2. VIDAS module. Indicates the VIDAS analytical module currently running.

3. Number of predefined reserved section. Displays the number of the

predefined section that has been reserved.

Fig. IV 16: Loading plan window

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Instructions for use

Running assays

You can now view the loading plans of the VIDAS 1 or VIDAS 2 modules with their sections labeled A to E.

• In the VIDAS 2 loading plan, click on the VIDAS 1 icon (colored and

enabled) to view the VIDAS 1 loading plan.

Load help screen

•

In the VIDAS 1 loading plan, click on the VIDAS 2 icon (colored and enabled) to view the VIDAS 2 loading plan.

You must then load each chosen section with the appropriate reagents and samples using the loading plans shown on the screen.

The load help screen (mark 1) enables you to find an assay which has been reserved or is being run, by searching for the patient ID or the sample ID.

•

Select the "Patient" or "Sample" option box.

•

Enter the information manually or using the bar code reader. You must respect upper case and lower case characters.

• Press <TAB> to quit.

The corresponding section is automatically selected and displayed on the screen.

The "Run" icon is used to start a section.

The "Run all" icon is used to start all the reserved sections in the VIDAS module.

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Instructions for use

Running assays

Printing

VIDAS : 2 Technician : Robert Printed on Aug 02 2005 13:57:14 Section

---------A:497 1

B:498 1

C 1

D 1

E 1

Position

----------

2 3 4 5 6

• To print the loading plan displayed on the screen, click on this icon.

Loading report

Assay

-------HCG HCG HCG HCG

HBS HBS HBS HBS HBS

Dilution

----------

Fig. IV 17: Loading report (example)

Patient ID

-------------

MOR564

MIL251

Patient name

------------------

MORTON

MILLER

Sample

---------S1 S1 C1 123564

S1 S1 C1 C2 659251

Quitting the menu

• You can return to the loading menu at any time by clicking on this icon.

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Instructions for use

Running assays

There are three different ways to run assays:

at the time of reservation of a section (see "Manual reservation" on page

−

4-25).

− − using the individual mode,

using the complete mode.

Individual mode

In the loading plan,

• click on the "Run" icon next to the desired section.

The icon disappears.

The status button of the section concerned switches from "RESER" to "VERIF".

It then changes to "busy" (analysis end time is displayed).

Complete mode

In the loading plan,

•

click on the "Run all" icon to start all the reserved sections in the VIDAS module.

The "Run" icons of each section disappear.

The status button of all the sections of the VIDAS module switch from "RESER" to "VERIF".

If an error occurs on one of the sections run in complete mode, only the section with the error will be jammed. To correct the error:

•

Check what type of error has occurred (see the instructions on page 8-30, "Error window").

•

Reset the section to enable the assay to continue (see the instructions on page 8-28, "Resetting a section").

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Instructions for use

Running assays

Errors

The instrument and reagents are checked for errors. If an error occurs, the

section concerned changes to red and displays the type of error.

Operating errors or errors occurring during analysis, are described in "Error window" on page 8-30 as well as in Chapter 12 "Troubleshooting".

Halting an assay

You can halt an assay that is being run in one or several sections. This procedure is described in the "Instrument" menu on page 8-28.

4-34 VIDAS

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Biomerieux Vidas PC User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

General warnings

Table of Contents

List of figures

Finding topics and procedures

Typographic conventions

Warnings

Graphic symbols

2 Functional description

Description / Aim

General features

Principle of operation

3 Getting started

Safety instructions

Precautions for use of reagents

Control devices

Starting VIDAS PC

Shutting down VIDAS PC

Changing the system date and time

User management

Creating a user

Modifying a user

Deleting a user

Unlocking a user account

Opening a session for a new user

Selecting a default printer

Logging on with a user group after opening a session

Changing the password

Locking and unlocking the VIDAS PC software

Locking and unlocking the BCI RS232 software

Theory of operation

User interface

Entering assays (or assay requests)

Transferring assays

Reserving sections

Running assays