Biomerieux Vidas PC User Manual

REF : 93 073

Version : F

05/2008

VIDAS® PC

User's Manual

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

Tel. 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

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)

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

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.

bioMérieux, the blue logo, VIDAS, BCI RS232 and BCI NET are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of its subsidiaries.

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

4501-1577 A en

SOFTWARE LICENSE AGREEMENT

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

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.

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

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

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

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.

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

1 How to use this manual 1-1

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

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

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

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

2 Functional description 2-1

Description / Aim.................................................................................................................................. 2-2

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

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

3 Getting started 3-1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Changing the password when opening Windows®....................................................................... 3-29

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

VIDAS® PC User's Manual V-1

Table of Contents

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

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

4 Instructions for use 4-1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Managing creation of predefined sections for two connected VIDAS®

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

V-2 VIDAS

PC User's Manual

Table of Contents

5 Updating a VIDAS assay 5-1

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

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

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

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

6 Calibration 6-1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

7 Results 7-1

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

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

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

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

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

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

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

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

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

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

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

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

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

8 The different VIDAS PC menus 8-1

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

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

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

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

VIDAS® PC User's Manual V-3

Table of Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

9 Backup 9-1

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

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

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

V-4 VIDAS

PC User's Manual

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

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

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

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

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

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

1 How to use this manual

Introduction

This manual covers the procedures for the major functions of the VIDAS as well as its software and consumables.

It also deals with the various procedures relating to the VIDAS installation and start-up.

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

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

to do so.

You are advised to read and understand all the instructions in this manual to be able to derive the best performance from your VIDAS.

VIDAS

PC User's Manual 1-1

How to use this manual

Finding topics and procedures

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

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

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

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

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

+ 264 hidden pages

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