Biomerieux mini Vidas User manual

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Page 1

mini VIDAS

Procedures Manual

4501 - 1721 en

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

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

http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

REF

version F

99188

07/2008

Page 2

Page 3

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

2 57 290 623 / (420) 2 57 290

tel. (420) 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 (5th Floor) 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

& 2nd Floor, Yoosung Building # 830-67 Yoksam-dong, Kangnam ku Seoul 135-080 tel. (82) 2 2188 4700 fax (82) 2 547 6263

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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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Revisions

The list of revisions below summarizes remplacements or additional pages in your Procedures Manual.

Version

A 03/1996 Creation All

B 03/2003 New format (7x9) - Manual update All

C 04/2005 Modification relating to the new mini VIDAS®

D Not used

E 10/2005 New software version All

F 07/2008 New software version

Date of

printing

Modifications Page (s) modified

All

model

All

mini VIDAS® Procedures Manual Revisions-1

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4501-1618 A en

The content of this manual is based on the Software release 5.3.0.

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 an d f o l l o w i n g a r t i c l e s o f t h e F r e n c h I n te l l e c t u a l P r operty 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 and mini VIDAS are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of its subsidiaries.

Dacron is a used, pending and/or registered trademark belonging to Invista North America, SARL. 7X is a used, pending and/or registered trademark belonging to MP Biomedicals, LLC. Alconox and Liquinox are used, pending and/or registered trademarks belonging to Alconox, Inc.

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4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: Release: Computer: Brand name: Printer: Brand name: Disk player: Brand name:

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

conditions.

I – Purpose of this Agreement / Rights granted

bioMérieux S.A. hereby grants, to the User who, by using this manual, accepts a non-exclusive right to use the Software. The license is personal, non transferable, non assignable and does not comprise the right to grant sub-licenses.

The User expressly agrees, in its own name and behalf as well as in the name and on behalf of its employees, agents and collaborators, not to make any copy of the Software-except one single backup copy for archival purposes- display the Software on any computer other than the Computer, reproduce, sell, rent, lease, modify, adapt, translate or otherwise dispose of, all or part of the Software, the equipment, the user manual and its related documentation.

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

II – Intellectual Property

All intellectual property rights including patrimonial rights, in and to the Software are and shall remain bioMérieux S.A. exclusive property, subject to possible third party rights. Consequently, the User is not entitled to copy or reproduce the Software except as set forth above.

Except as expressly specified above, nothing contained herein shall be construed as conferring to the User any right, title or interest in and to the Software.

III – Warranties

Provided that this Agreement duly signed is received by bioMérieux S.A. within ten (10) business days from the delivery, bioMérieux S.A. warrants that the Software is free from defect in materials and workmanship under normal conditions of use during three (3) months from the delivery. Should any defect occur during such period, bioMérieux S.A. or one of its authorized distributors in the country of sale shall replace the Software provided that the User makes its request in writing together with copy of the Software invoice and, as the case may be, the defective media.

Apart from the foregoing, the Software is provided "AS IS" and no warranty, whether express or implied, of merchantability, safety, quality, or fitness for a particular purpose is given hereunder nor any warranty that the Software shall not infringe upon the intellectual property rights of any third party

Page 10

The warranty provided herein shall apply provided that Software is used under normal conditions and to the exclusion of any replacement caused by accidental or willful damage, or misuse of the software or accident whatsoever.

It is expressly understood that, according to this License, bioMérieux S.A. shall not perform any service related to the training, assistance or maintenance of the Software unless otherwise agreed upon between the parties through a separate written agreement setting forth the terms and conditions (in particular, financial conditions) of such training, assistance or maintenance.

IV – Liability

In no event shall bioMérieux S.A. be liable for consequences related to, arising out of or in connection with, modifications of Software by anyone other than bioMérieux S.A.

In no event shall bioMérieux S.A. be liable for any direct, indirect, special, consequential, incidental or material damage (including loss of goodwill, profits, data or any other economic advantage) related to, arising out of or in connection with, any use of the Software and/or its results by the User and/or any third party, including without limitation, its clients, customers and sub-contactors. User hereby agrees to indemnify, defend and hold bioMérieux S.A. harmless from all claims, damages, expenses, suits, losses or liabilities relating to, arising out of or in connection with User or such parties as well for any action of such third parties against bioMérieux S.A.

Should this provision be held unenforceable or void, the User irrevocably agrees that bioMérieux S.A. liability and expenses for all causes shall not exceed the total amount actually paid by the User hereunder for the software release concerned by the claim.

V – Applicable Law and settlement of disputes

This agreement is governed and construed in accordance with French Law. Parties shall make their best efforts to settle any dispute through amicable

discussions. In the event no amicable settlement is reached in the period of three (3) months after communication of the claim, any litigation shall be held in the exclusive jurisdiction of the courts of Lyon, France.

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

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

Signature and User's stamp:

COPY TO BE RETURNED TO BIOMERIEUX

S.A.

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4501-1577 A en

SOFTWARE LICENSE AGREEMENT

User: No.: Software: Release: Computer: Brand name: Printer: Brand name: Disk player: Brand name:

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

conditions.

I – Purpose of this Agreement / Rights granted

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

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

Page 12

IV – Liability

In no event shall bioMérieux S.A. be liable for consequences related to, arising out of or in connection with, modifications of Software by anyone other than bioMérieux S.A.

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

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

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

Signature and User's stamp:

COPY TO BE KEPT BY USER

Page 13

General Warnings

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

Protective gloves must be worn when manipulating blood, products

derived from blood or objects contaminated with blood.

Qualified laboratory personnel should use acceptable procedures for

biohazardous material.

WARNING! 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 mini 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.

IMPORTANT ! Read this manual carefully to obtain optimum performance from your

mini VIDAS.

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

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

Page 14

WARNING! bioMérieux SA is in no case liable for any changes made to the equipment

without authorization from bioMérieux SA.

Electromagnetic Compatibility (EMC): This is a Class A product. In a residential area, this product may cause harmful interference in which case the user may be required to take adequate measures at his own expense.

The equipment may also cause inteference if not installed in accordance with the instructions given in this manual.

Never download into the computer, programs other than those provided by bioMérieux SA. If these instructions are not complied with, the computer could become infected with computer viruses. Any intervention directly or indirectly resulting from the presence of such a virus cannot be covered by the warranty or the maintenance contract.

This statement only applies to the EC and instruments bearing the

symbol with regard to the waste electrical and electronic equipment.

You can play an important role in contributing to reuse, recycling and

other forms of recovery of waste electrical and electronic equipment. Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment.

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

Page 15

1 How to use this manual..................................................................................................................... 1-1

Finding topics or procedures................................................................................................................ 1-2

Typographic conventions ..................................................................................................................... 1-4

The mini VIDAS keypad....................................................................................................................... 1-4

Graphic symbols .................................................................................................................................. 1-6

2 Parts of the mini VIDAS..................................................................................................................... 2-1

The mini VIDAS hardware ................................................................................................................... 2-2

Sections ......................................................................................................................................... 2-3

Reagent strip tray ..................................................................................................................... 2-3

SPR® block ............................................................................................................................... 2-4

Operating status light................................................................................................................ 2-4

Microprocessor ......................................................................................................................... 2-4

Incubators................................................................................................................................. 2-4

Strip preparation tray ................................................................................................................ 2-5

Detection system............................................................................................................................ 2-6

Central processing unit................................................................................................................... 2-6

Keypad and screen ........................................................................................................................ 2-6

Internal printer ................................................................................................................................ 2-7

Rear panel components ................................................................................................................. 2-8

Bar code readers.......................................................................................................................... 2-10

Recommendations for use of the bar code reader.................................................................. 2-10

Possibilities of extension.................................................................................................................... 2-11

The mini VIDAS software................................................................................................................... 2-12

The mini VIDAS menus ................................................................................................................ 2-12

Selecting a menu option .........................................................................................................2-13

Menu structure........................................................................................................................ 2-14

The status screen......................................................................................................................... 2-15

The first status screen ............................................................................................................ 2-15

The second status screen....................................................................................................... 2-18

The third status screen ........................................................................................................... 2-19

Online help ................................................................................................................................... 2-20

Viewing error messages............................................................................................................... 2-21

Screen paging .............................................................................................................................. 2-21

Paging bar .............................................................................................................................. 2-22

Memory cards............................................................................................................................... 2-23

The assay kit...................................................................................................................................... 2-24

Single reagent strip ...................................................................................................................... 2-24

Dual reagent strip ......................................................................................................................... 2-25

The label ...................................................................................................................................... 2-25

The SPR....................................................................................................................................... 2-27

How the SPR functions...........................................................................................................2-28

mini VIDAS® Procedures Manual V-1

Page 16

Table of contents

Getting started ................................................................................................................................... 3-1

Aim / Description.................................................................................................................................. 3-2

Precautions for installation and use ..................................................................................................... 3-3

Unpacking the mini VIDAS................................................................................................................... 3-5

Preparations before unpacking....................................................................................................... 3-5

Starting the mini VIDAS ....................................................................................................................... 3-7

Shutting down the mini VIDAS ........................................................................................................... 3-10

Configuring the mini VIDAS ............................................................................................................... 3-11

Setting dose units......................................................................................................................... 3-12

Setting user ID.............................................................................................................................. 3-14

Setting the report header.............................................................................................................. 3-16

Setting the date and time.............................................................................................................. 3-17

Setting display contrast ................................................................................................................3-18

Selecting the printer ..................................................................................................................... 3-19

Setting the date/time format .........................................................................................................3-20

Defining the sample ID character sets.......................................................................................... 3-23

Changing the keyclick volume ...................................................................................................... 3-25

Changing the beep volume........................................................................................................... 3-26

Error beeps................................................................................................................................... 3-27

Setting initial error volume ...................................................................................................... 3-27

Setting the final error volume ..................................................................................................3-28

Enabling display blinking .............................................................................................................. 3-29

Miscellaneous items ..................................................................................................................... 3-30

LIS user options ........................................................................................................................... 3-34

Creating normal ranges for assays...............................................................................................3-36

Installing paper in the printer.............................................................................................................. 3-38

Print screen........................................................................................................................................ 3-40

4 Routine procedures ........................................................................................................................... 4-1

Precautions for use of reagents ........................................................................................................... 4-2

Specificities of the mini VIDAS blue .......................................................................................... 4-2

Basic mini VIDAS work flow................................................................................................................. 4-3

Planning a run...................................................................................................................................... 4-8

Type of run required ....................................................................................................................... 4-8

Defined vs. load and go runs ....................................................................................................4-8

Assay compatibility......................................................................................................................... 4-9

Standards and controls................................................................................................................. 4-10

Standards ............................................................................................................................... 4-10

Controls ..................................................................................................................................4-10

Summary of the mini VIDAS software .......................................................................................... 4-11

V-2 mini VIDAS® Procedures Manual

Page 17

Table of contents

Running assays ................................................................................................................................. 4-13

Assay requests............................................................................................................................. 4-13

Starting a load and go run ............................................................................................................ 4-13

Starting a defined run ................................................................................................................... 4-16

Assigning a dilution factor ............................................................................................................ 4-24

Calibration – Recalibration................................................................................................................. 4-27

Principles of calibration using the mini VIDAS.............................................................................. 4-27

Theoretical principle................................................................................................................ 4-27

Principle applied to mini VIDAS .............................................................................................. 4-28

Principles of recalibration using mini VIDAS ................................................................................ 4-29

Theoretical principle................................................................................................................ 4-29

Principle of use ....................................................................................................................... 4-29

Establishing the master curve................................................................................................. 4-31

How to calibrate............................................................................................................................ 4-32

Master Lot data– Principle of calibration................................................................................. 4-32

Procedure ............................................................................................................................... 4-32

Entering master lot data..................................................................................................................... 4-33

Automatic entry via the Master Lot Entry (MLE) card................................................................... 4-34

Error reading the card............................................................................................................. 4-36

Manual master lot data entry (option 2)........................................................................................ 4-37

Case 1 .................................................................................................................................... 4-37

Case 2 .................................................................................................................................... 4-40

Listing stored standards..................................................................................................................... 4-43

Listing master lots .............................................................................................................................. 4-45

Halting a section ................................................................................................................................ 4-46

5 Results and reports ........................................................................................................................... 5-1

Analysis methods................................................................................................................................. 5-1

Terminology ................................................................................................................................... 5-2

Qualitative assays: single reagent strips ........................................................................................ 5-3

Qualitative assays: dual reagent strips........................................................................................... 5-4

Quantitative assays ........................................................................................................................ 5-5

The assay report .................................................................................................................................. 5-6

Qualitative assays: single reagent strip .......................................................................................... 5-8

Qualitative Assays: dual reagent strip ............................................................................................ 5-9

Quantitative assays ...................................................................................................................... 5-10

Assay report errors ............................................................................................................................ 5-11

Reprinting an assay report................................................................................................................. 5-12

Validating LIS results ......................................................................................................................... 5-15

Printing the mini VIDAS assay list...................................................................................................... 5-18

mini VIDAS® Procedures Manual V-3

Page 18

Table of contents

Miscellaneous operations ................................................................................................................. 6-1

Taking a section off line .......................................................................................................................6-2

Changing factory settings..................................................................................................................... 6-3

Accessing the factory settings ........................................................................................................ 6-3

Selecting a language...................................................................................................................... 6-5

Testing the mini VIDAS instrument ...................................................................................................... 6-7

Accessing the tests ........................................................................................................................ 6-7

Testing the display ......................................................................................................................... 6-7

Decrease in the intensity of display .......................................................................................... 6-7

Testing the keypad ......................................................................................................................... 6-8

Testing the printer .......................................................................................................................... 6-9

Testing the audio output ................................................................................................................. 6-9

Updating an assay ............................................................................................................................. 6-10

Purpose of the assay update........................................................................................................ 6-10

Updating ....................................................................................................................................... 6-10

Preliminary instructions........................................................................................................... 6-10

Reading assay update card bar codes ................................................................................... 6-11

Displaying the mini VIDAS software version ...................................................................................... 6-15

Printing the mini VIDAS software version........................................................................................... 6-16

Displaying the assay version.............................................................................................................. 6-17

Section counters ................................................................................................................................ 6-19

Printing the assay version.................................................................................................................. 6-20

Updating the mini VIDAS software via the memory card.................................................................... 6-21

Verifying the memory card data ......................................................................................................... 6-24

Shipping the mini VIDAS.................................................................................................................... 6-25

7 Error handling .................................................................................................................................... 7-1

The error message alert system .......................................................................................................... 7-2

Responding to an error alert........................................................................................................... 7-2

Types of error message screens .................................................................................................... 7-3

Start errors ........................................................................................................................................... 7-4

What happens? .............................................................................................................................. 7-4

What you should do........................................................................................................................ 7-5

How to resolve start errors .............................................................................................................7-7

Remedies for start errors (except bad bar code) ...................................................................... 7-7

Manually entering bar codes ..........................................................................................................7-9

Substrate error ............................................................................................................................. 7-11

Expired lot error............................................................................................................................ 7-11

Other error messages................................................................................................................... 7-12

V-4 mini VIDAS® Procedures Manual

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Table of contents

Instrument errors................................................................................................................................ 7-13

Error messages............................................................................................................................ 7-14

Problems that may occur with the bar code reader............................................................................ 7-22

Assay report errors ............................................................................................................................ 7-23

Correcting assay report errors...................................................................................................... 7-23

Assay report error symbols .......................................................................................................... 7-23

Error messages on assay reports.................................................................................................7-24

Printer errors...................................................................................................................................... 7-25

Viewing saved errors ......................................................................................................................... 7-26

Displaying instrument temperatures................................................................................................... 7-27

Printing instrument temperatures ....................................................................................................... 7-28

8 Appendices......................................................................................................................................... 8-1

Appendix A: Specifications .................................................................................................................... 8-3

Characteristics ..................................................................................................................................... 8-3

Environmental requirements .......................................................................................................... 8-3

Physical features............................................................................................................................ 8-3

Dimensions............................................................................................................................... 8-3

Physical space requirements.................................................................................................... 8-3

Sound level............................................................................................................................... 8-3

Mass ......................................................................................................................................... 8-3

Electrical requirements................................................................................................................... 8-4

Technical features .......................................................................................................................... 8-6

Temperature control ....................................................................................................................... 8-6

Optics ............................................................................................................................................. 8-7

Test kit............................................................................................................................................ 8-7

Appendix B: Maintenance....................................................................................................................... 8-9

Introduction .......................................................................................................................................... 8-9

Preventive maintenance .................................................................................................................... 8-10

User maintenance.............................................................................................................................. 8-11

Tools required for maintenance.................................................................................................... 8-11

Summary of user maintenance operations................................................................................... 8-12

Decontamination of the mini VIDAS blue ........................................................................................... 8-13

Cleaning the SPR block ............................................................................................................... 8-13

Cleaning the strip preparation tray ......................................................................................... 8-16

Cleaning the reagent strip trays.................................................................................................... 8-17

Cleaning the plastic trays ............................................................................................................. 8-19

Reassembling the strip preparation tray and powering on the analytical

module ......................................................................................................................................... 8-20

Reassembling the strip preparation tray ................................................................................. 8-20

Powering on the analytical module ......................................................................................... 8-20

mini VIDAS® Procedures Manual V-5

Page 20

Table of contents

Decontamination of the mini VIDAS ................................................................................................... 8-21

Cleaning the SPR block................................................................................................................ 8-21

Cleaning the reagent strip trays.................................................................................................... 8-23

Cleaning the plastic tray ............................................................................................................... 8-25

Replacing the front panel and powering on the analytical module................................................ 8-26

Replacing the front panel ........................................................................................................ 8-26

Powering on the analytical module ......................................................................................... 8-26

Using the quality control test .............................................................................................................. 8-27

Cleaning the computer screen and keypad........................................................................................ 8-27

Cleaning the bar code reader............................................................................................................. 8-27

Appendix C: Quality control ................................................................................................................. 8-29

Checking performance ....................................................................................................................... 8-29

Optics for the mini VIDAS............................................................................................................. 8-29

How it works ................................................................................................................................. 8-29

Manual optics calibration.............................................................................................................. 8-30

Self diagnostics ............................................................................................................................ 8-30

Auto-calibration of the optical system................................................................................................. 8-31

How it works ................................................................................................................................. 8-31

Pipetting for the mini VIDAS............................................................................................................... 8-33

How it works ................................................................................................................................. 8-33

Pipetting calibration and self diagnostics......................................................................................8-33

Using the reagent for testing the pipette mechanisms.................................................................. 8-34

Temperature validation for the mini VIDAS ........................................................................................ 8-34

How it works ................................................................................................................................. 8-34

Self diagnostics ............................................................................................................................ 8-34

mini VIDAS master curve establishment and calibration.................................................................... 8-35

Definitions and principles of calibration/recalibration.................................................................... 8-35

Establishing the master curve (performed at the factory) ............................................................. 8-35

Establishing the calibration curve (performed by the customer) ................................................... 8-36

Master lot data.............................................................................................................................. 8-37

V-6 mini VIDAS® Procedures Manual

Page 21

Table of contents

Appendix D: Installing optional external hardware ............................................................................ 8-39

External printer................................................................................................................................... 8-39

Materials required......................................................................................................................... 8-39

Before installation......................................................................................................................... 8-39

Installation .................................................................................................................................... 8-39

Testing the external printer ................................................................................................................ 8-40

Possible error message ..........................................................................................................8-40

Installing the bar code reader ............................................................................................................ 8-41

Preparing the reader .................................................................................................................... 8-41

Before installation......................................................................................................................... 8-41

Reading bar codes ....................................................................................................................... 8-42

Installing the bar code reader wand .............................................................................................8-43

Appendix E: Computer interface information ..................................................................................... 8-45

Introduction ........................................................................................................................................ 8-45

Configuration information................................................................................................................... 8-48

LIS user options ........................................................................................................................... 8-48

LIS interface options..................................................................................................................... 8-49

Example of a mini VIDAS upload ....................................................................................................... 8-50

9 Glossary ............................................................................................................................................. 9-1

10 Index ................................................................................................................................................. 10-1

NOTES Notes-1

mini VIDAS® Procedures Manual V-7

Page 22

Page 23

List of figures

Note : Screen captures and figures are given as examples only.

2 Parts of the mini VIDAS

Fig. 2-1: The mini VIDAS blue..................................................................... 2-2

Fig. 2-2: The mini VIDAS ......................................................................................... 2-2

Fig. 2-3: Reagent strip tray ...................................................................................... 2-3

Fig. 2-4: SPR block .................................................................................................. 2-4

Fig. 2-5: Strip preparation tray closed...................................................................... 2-5

Fig. 2-6: Opening the strip preparation tray ............................................................. 2-5

Fig. 2-7: Reagent strips placed on the strip preparation tray ................................... 2-5

Fig. 2-8: Reagent strip placed on the strip preparation tray with its boat ................. 2-5

Fig. 2-9: Optical cuvette on a reagent strip .............................................................. 2-6

Fig. 2-10: mini VIDAS blue keypad and screen ....................................................... 2-6

Fig. 2-11: mini VIDAS keypad and screen ............................................................... 2-6

Fig. 2-12: mini VIDAS rear panel ............................................................................. 2-8

Fig. 2-13: mini VIDAS Main Menu.......................................................................... 2-12

Fig. 2-14: Showing active selection keys ............................................................... 2-13

Fig. 2-15: mini VIDAS menu structure ................................................................... 2-14

Fig. 2-16: First status screen ................................................................................. 2-15

Fig. 2-17: Second status screen ............................................................................ 2-18

Fig. 2-18: Third status screen ................................................................................ 2-19

Fig. 2-19: Help mode screen.................................................................................. 2-20

Fig. 2-20: Single reagent strip................................................................................ 2-24

Fig. 2-21: Dual reagent strip .................................................................................. 2-25

Fig. 2-22: Reagent strip label................................................................................. 2-25

Fig. 2-23: Solid phase receptacle (SPR)................................................................ 2-27

mini VIDAS

3 Getting started

Fig. 3-1: mini VIDAS dust covers ............................................................................. 3-6

Fig. 3-2: Power switch.............................................................................................. 3-7

Fig. 3-3: Accessing the Configuration Menu .......................................................... 3-11

Procedures Manual VI-1

Page 24

List of figures

4 Routine procedures

Fig. 4-1: Basic mini VIDAS work flow....................................................................... 4-4

6 Miscellaneous operations

Fig. 6-1: Accessing the Configuration Menu ............................................................6-4

Fig. 6-2: Accessing the Test Menu........................................................................... 6-6

Fig. 6-3: Assay update card bar code screen......................................................... 6-11

Fig. 6-4: Example of a bar code............................................................................. 6-12

Fig. 6-5: Status after reading.................................................................................. 6-13

Fig. 6-6: mini VIDAS back panel............................................................................ 6-21

8 Appendices

Fig. 8-1: Opening the section fully.......................................................................... 8-13

Fig. 8-2: Cleaning the SPR block........................................................................... 8-14

Fig. 8-3: Cleaning the rear of the SPR block.......................................................... 8-14

Fig. 8-4: Opening the strip preparation tray ........................................................... 8-16

Fig. 8-5: Cleaning the strip preparation tray........................................................... 8-16

Fig. 8-6: Dismantling the strip preparation tray ...................................................... 8-17

Fig. 8-7: Removing the strip preparation tray ......................................................... 8-17

Fig. 8-8: Cleaning the reagent strip trays ............................................................... 8-18

Fig. 8-9: Cleaning the plastic tray........................................................................... 8-19

Fig. 8-10: Cleaning the SPR block ......................................................................... 8-21

Fig. 8-11: Cleaning the rear of the SPR block........................................................ 8-22

Fig. 8-12: Removing the front panel....................................................................... 8-23

Fig. 8-13: Cleaning the reagent strip trays ............................................................. 8-24

Fig. 8-14: Cleaning the plastic tray......................................................................... 8-25

Fig. 8-15: Replacing the front panel ....................................................................... 8-26

Fig. 8-16: Location of printer port ........................................................................... 8-39

Fig. 8-17: Location of diagnostic port ..................................................................... 8-43

VI-2 mini VIDAS

Procedures Manual

Page 25

1 How to use this manual

Introduction

The mini VIDAS Procedures Manual is a complete guide for the mini VIDAS. It includes the information you need to:

− Install and set up the instrument,

− Operate the hardware and software portions of the mini VIDAS,

− Obtain and interpret reports,

− Identify and correct some of the errors that may occur.

As you become more familiar with the easy-to-use procedures of the mini VIDAS, you will find that this manual becomes more a reference than a companion guide.

It has, however, been organized to both guide new users through their first experiences with the mini VIDAS, and also to serve the more experienced users who may need occasional help.

mini VIDAS

Procedures Manual 1-1

Page 26

How to use this manual

Finding topics or procedures

∗ To help you find the information you want, this manual is divided into 10

chapters. The first 7 contain the topics and procedures.

Chapter 8 includes the Appendices. Chapter 9 is the Glossary of technical terms. Chapter 10 is the Index.

Table of contents

List of figures

Warnings

Chapter contents

Graphic symbols

Page Headers

The main table of contents for the manual is located on pages V-1 to V-7 It lists each chapter and the procedures within each chapter.

Pages VI-1 to VI-2 contains a list of the figures in the manual.

Different types of warnings are used throughout the manual:

- for safety reasons (DANGER!),

- to ensure that the instruments are maintained in good working condition

(CAUTION!),

- for regulatory reasons (WARNING!) or,

- for optimum performance of operations, procedures, etc. (IMPORTANT!).

Every chapter containing procedures begins with a mini table of contents specifically for the chapter.

The standard symbols used for bioMérieux 1-6.

Apart from the first page of every chapter, each page of the manual includes a page header and a footer. Each page header includes the chapter title and the title of a procedure or its corresponding description. These titles are located on the outside of the page so that you can thumb through the pages to quickly locate a chapter or a procedure. The footers contain the title of the manual, the name of the product and the page number.

instruments can be found on page

1-2 mini VIDAS

Procedures Manual

Page 27

How to use this manual

Finding topics or procedures

Notes

Glossary

Index

Sheet of decontamination

labels

This manual contains a certain number of notes that are used to emphasize a procedure or certain information.

The glossary is located in chapter 9 of the manual. It gives the definition of the main technical terms used in the manual.

The index is located in chapter 10 at the back of the manual. It is used to locate a particular description or procedure.

One of these labels is stuck on the instrument to certify that it has been properly decontaminated:

− before any operations by a service technician,

− before it is returned to the factory, if necessary.

This icon is used to indicate specific information concerning the mini VIDAS instrument called "mini VIDAS blue" in the manual.

Unless otherwise specified, the information in the manual applies to the mini VIDAS, whichever model is used.

mini VIDAS

Procedures Manual 1-3

Page 28

How to use this manual

Typographic conventions

∗ Following are the terms and visual cues used in this manual to aid in your

understanding of the procedures.

• Press

INSTALL

Reading

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

This typography is used for messages that appear on the screen (except error messages which appear in bold type).

This typography is used to represent selection keys, e.g

• Select [Utility Menu].

The mini VIDAS keypad

There are 24 keys on the mini VIDAS keypad. They are divided among four groups, according to their function:

Number keys

Function keys

A standard set of digits, as you would find on a calculator. When referring to these keys, we use their general name enclosed in angle

brackets "< >" : <Number key>. Three keys with specially programmed functions. In procedures, these keys are referred to by their individual names, enclosed in

angle brackets "< >".

• Press <Previous Screen> to return to the menu.

Note: Detailed descriptions of these function keys are in Chapter 2 on page 2-7.

Arrow keys

1-4 mini VIDAS

Four keys used to move the cursor on the screen. The arrow keys are referenced by their direction, enclosed in angle brackets

"< >" : <↑>, <↓>, <←> and <→>.

Procedures Manual

Page 29

How to use this manual

The mini VIDAS keypad

Selection keys

Five keys used to select options from the screen. The selection keys are used most often when the instrument is running. An operation involving a selection key always begins with "Select". For other operations, the word "Press" is used.

The use of a selection key is always associated with a selection option displayed on the screen. The name of the option appears in parentheses. A selection referenced specifically by name appears in parentheses and in bold type. E.g.

• Select [Utility Menu] in the Main Menu.

mini VIDAS

Procedures Manual 1-5

Page 30

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)

1-6 mini VIDAS

Procedures Manual

Page 31

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

REF

mini VIDAS

LOT

or REF

Procedures Manual 1-7

Consult Instructions for Use

Batch code

Catalogue number

Temperature limitation

Page 32

How to use this manual

Graphic symbols

EC REP

IVD

or SN

Authorised Representative in the European Community

Keep dry

Manufacturer

Date of manufacture

In Vitro Diagnostic Medical Device

Serial number

Keep away from magnetic field

Separate collection for waste electrical and electronic equipment

1-8 mini VIDAS

Procedures Manual

Page 33

2 Parts of the mini VIDAS

Introduction

Each section in the chapter provides a description of the mini VIDAS and mini VIDAS blue components.

The following procedures are described in this chapter:

♦ The mini VIDAS hardware ......................................................................... 2-2

♦ Possibilities of extension.......................................................................... 2-11

♦ The mini VIDAS software......................................................................... 2-12

♦ The assay kit............................................................................................ 2-24

mini VIDAS® Procedures Manual 2-1

Page 34

Parts of the mini VIDAS

The mini VIDAS hardware

The mini VIDAS is a completely self-contained unit, intended for use with VIDAS assay kits.

Fig. 2-1: The mini VIDAS

blue Fig. 2-2: The mini VIDAS

∗ The hardware contains the following elements:

− Space to insert up to 12 single or 6 dual reagent strips.

− A fluorometric optical system.

− A mechanical system that processes the tests.

− An incubation system to maintain all components at required temperatures.

− A central processing unit to control the entire mini VIDAS.

− A keypad and screen.

− A thermal printer.

− A strip preparation tray which is used to prepare reagent strips when assays

are already running (only concerns mini VIDAS blue).

−

A bar code reader to read encoded information from the reagent strip label

and Master Lot Data Cards.

CAUTION! Never use material other than that specified by bioMérieux

2-2 mini VIDAS

SA.

Procedures Manual

Page 35

Parts of the mini VIDAS

The mini VIDAS hardware

Sections

The analytical portion of the mini VIDAS contains two compartments called “Sections.”

Labeled A and B, the sections operate independently, allowing a variety of tests to be run on the mini VIDAS at the same time.

Reagent strip tray

On the lower portion of each section, a plastic dust cover can be lifted to reveal the reagent strip tray.

The tray, shown in the figure below, consists of six channels into which you can slide a reagent strip.

Each of the six channels constitutes a position in the section. You can insert up to six single, or three dual reagent strips for a combined

capacity of up to 12 tests. The tray is pulled into the instrument during processing.

CAUTION! The reagent strip trays are movable parts.

mini VIDAS

Fig. 2-3: Reagent strip tray

The strip tray is also used to automatically enter the MLE card.

Note: See chapter 4 "Routine procedures" in this Manual for more information on the MLE Card.

Risk of finger pinching.

Procedures Manual 2-3

Page 36

Parts of the mini VIDAS

The mini VIDAS hardware

SPR® block

The upper portion of a section has a door that pulls down to reveal the SPR block.

The main feature of this compartment is the six-position SPR

block, used to hold

the SPRs, or Solid Phase Receptacles. The six positions of the block correspond to the six positions in the reagent strip

tray. During processing, the SPR

block and SPR form a pipetting system that is used

in the various steps of the assay process.

Fig. 2-4: SPR block

Operating status light

A small light above the SPR block door indicates the operating status of each section.

When the section is running a test, the light is on; when the light is off, the section is idle.

A flashing light indicates that the tests in that section are completed, and that the reagent strips and SPRs should be removed.

Microprocessor

In addition to the central processing unit, each section of the mini VIDAS contains its own microprocessor.

This unit is responsible for storing and operating the assay protocols. A protocol is a series of commands that include the mixing of reagents, washing

steps, and optical readings. It allows the mini VIDAS to perform a completely automated assay.

Incubators

The assays used in the mini VIDAS require temperature control. Two systems control temperature, one in the reagent strip tray and the other in

the SPR

Note: For information on temperature monitoring in the mini VIDAS, see Chapter 7.

block.

2-4 mini VIDAS

Procedures Manual

Page 37

Parts of the mini VIDAS

The mini VIDAS hardware

Strip preparation tray

(only concerns mini VIDAS blue)

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

②

①

Fig. 2-5: Strip preparation tray closed Fig. 2-6: Opening the strip preparation tray

mini VIDAS

Fig. 2-7: Reagent strips placed on the

strip preparation tray

Procedures Manual 2-5

Fig. 2-8: Reagent strips placed on the

strip preparation tray with its boat

Page 38

Parts of the mini VIDAS

The mini VIDAS hardware

Detection system

The mini VIDAS uses a fluorometric scanner as the detection system. The scanner is mounted on a mechanical device that permits it to be used for

both sections. The mini VIDAS detects chemical changes in the specialized optical cuvette

mounted at the end of every reagent strip. Figure II-9 shows the position of the optical cuvette in a typical reagent strip.

Central processing unit

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

Keypad and screen

The keys on the mini VIDAS console are almost completely flat. They are used to enter information which is taken directly into account when the key is pressed.

The screen is a liquid crystal type. It conveys all communications from the onboard computer.

Nota: If the intensity of the mini VIDAS blue display decreases considerably or becomes

irregular, refer to "Decrease in the intensity of display" on page 6-7. The running of the mini VIDAS blue is in no way affected.

Immediately to the right of the screen are five touch keys that are used to select items presented on the screen.

Optical cuvette

Fig. 2-9: Optical cuvette on a reagent strip

Fig. 2-10: mini VIDAS blue keypad and screen Fig. 2-11: mini VIDAS keypad and screen

2-6 mini VIDAS

Procedures Manual

Page 39

Parts of the mini VIDAS

The mini VIDAS hardware

Ref. Description

1: Display screen

2: Option selection keys

3: Numeric keypad

4: Function keys

This is where all instructions and messages for operating the mini VIDAS are displayed.

These five keys are used to select one of up to five options that can appear on the display screen. The options are displayed on the screen opposite the keys (which are black in the manual) used to select them.

These keys are used to input numbers into the mini VIDAS, and, in some cases, to make input selections. They include the ten digits, 0 - 9, a decimal point, and an

These three keys perform specific functions in the mini VIDAS.

The key represented by a question mark

<ENTER> key.

<?> is the help key.

• Press this key once to display information for the screen on which you are

working, to view an error after a sound signal has been emitted and/or a flashing screen (see the Configuration Menu).

• Press this key twice for a Help Mode Sceen that provides the following: print

screen, mini VIDAS status, information, assay compatibility list. This key is also used to display error messages.

5: Arrow keys

Internal printer

mini VIDAS

Procedures Manual 2-7

This key is used to return to the previous screen during a procedure It can be used to return to a particular menu or to correct a selection error.

The

<UNDO> key is used to undo a keypad input. In some cases it deletes the

last input and returns you to the previous operation.

These keys are used to move the cursor on certain screens. The

<↑>and <↓> keys are also used to page the display screen, that is, to show

a second or third page of output that does not fit on one screen.

The mini VIDAS includes an internally mounted thermal printer. The printer is located on the top of the mini VIDAS, directly above the keypad

and screen.

Page 40

Parts of the mini VIDAS

The mini VIDAS hardware

Rear panel components

The rear panel of the mini VIDAS contains several important hardware components.

The location of these components is shown in the figure below.



 





Fig. 2-12: mini VIDAS rear panel

2-8 mini VIDAS

Procedures Manual

Page 41

Parts of the mini VIDAS

The mini VIDAS hardware

Ref. Description

1: Memory card slot

2: Diagnostic port

3: Computer port

4: Printer port

This slot is the receptacle for the mini VIDAS software update cards. A memory card is sent to you to perform updates of the mini VIDAS software

when required.



This recyclable card must be returned to bioMérieux representative after your mini VIDAS has been upgraded.

This cable connection is used to troubleshoot the mini VIDAS and is not part of normal operation.

This cable connection can be used if problems occur with the instrument. If necessary, it will be used by a bioMérieux

This cable connection can be used to connect the mini VIDAS to a computer. Assay results are then sent to that computer via this connection.

This cable connection can be used to connect the mini VIDAS to a matrix parallel printer.

A parallel / Centronix-type cable and a printer are therefore required.



service technician.

SA or their local

5: AC power connection

mini VIDAS

Procedures Manual 2-9

This section of the rear panel contains the hardware for connecting the mini VIDAS to an AC power source. It includes:

− ON/OFF switch.

− Receptacle for an AC power cord.

− Fuse compartment.

Page 42

Parts of the mini VIDAS

The mini VIDAS hardware

Bar code readers

There are 2 readers:

∗ A hand-held bar code reader is included in the mini VIDAS configuration. It is

used to:

− read the bar codes of certain reagents before they are used. The procedure

for using these reagents is described in "Instructions for use" in the package insert.

− enter the sample ID and read MLE cards.

∗ A bar code reader inside the instrument enables identification of the reagent

strips and reading of the MLE card.

Recommendations 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 is visible 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 "Error handling".

2-10 mini VIDAS

Procedures Manual

Page 43

Parts of the mini VIDAS

Possibilities of extension

∗ External printer (optional)

Note: See section "Selecting the printer" on page 3-19 of chapter 3 and appendix D in this

manual.

∗ Bar code reader

Note: See section "Reading bar codes" on page 8-42 of this manual.

∗ Unidirectional interface (optional)

Note: See section "LIS user options" on page 3-34 of chapter 3 and appendix E in this manual.

mini VIDAS

Procedures Manual 2-11

Page 44

Parts of the mini VIDAS

The mini VIDAS software

The mini VIDAS menus

The mini VIDAS is menu-driven, that is, all of the parts of the software program are selected from a menu, rather than by entering commands.

The following figure for example, shows the Main Menu.

Fig. 2-13: mini VIDAS Main Menu

2-12 mini VIDAS

Procedures Manual

Page 45

Parts of the mini VIDAS

The mini VIDAS software

Selecting a menu option

Five selection keys, located to the right of the screen, enable you to select options in mini VIDAS menus.

∗ Since not all displays use all five selection keys, the boxed selections and lines

indicate the active keys. This display uses one of two methods to show the active keys. The figure on page 2-12 illustrates the first method. Notice that each option is in

a box with a line extending to a selection key.

∗ The other method of showing active selection keys is used where additional

information appears between the option and the selection key. The following figure shows the status screen for the two mini VIDAS sections,

A and B.

∗ The sections represent two of the three section options on this screen; the text

is status information for each section.

mini VIDAS

Fig. 2-14: Showing active selection keys

∗ Two things to note on the screen in Figure 2-14 are:

• The active selection keys are noted by the marker “•–” and the enclosed box

with a line extending to a selection key

• Only three of the five selection keys are active on this screen

Procedures Manual 2-13

Page 46

Parts of the mini VIDAS

The mini VIDAS software

Menu structure

The diagram in Figure 2-15 shows the entire structure of the mini VIDAS menus.

Notice that the Main Menu, as the entry point into the mini VIDAS, also serves as the pathway to the other menus in the mini VIDAS.

Several of the selections in the VIDAS Main Menu are other menus. This is reflected in the structure diagram below.

Fig. 2-15: mini VIDAS menu structure

When a menu is accessed from another menu, it is called a submenu. Each submenu in the mini VIDAS contains a particular group of programs that

are related. The Configuration Menu, for example, contains all the programs that set the

configuration of the mini VIDAS. The programs in the mini VIDAS Main Menu are those that you will use most

often.

2-14 mini VIDAS

Procedures Manual

Page 47

Parts of the mini VIDAS

The mini VIDAS software

The status screen

The second item in the mini VIDAS Main Menu is labeled “status screen”. This display is used to indicate the current status of the two sections in the

mini VIDAS, and to assign assays to them. The status screen is also used to display the temperature of each section’s tray

The first status screen

and SPR Knowing how to read the status screens is an important part of operating the

mini VIDAS.

The first status screen is shown in the figure below.

block.

Fig. 2-16: First status screen

mini VIDAS

Procedures Manual 2-15

Page 48

Parts of the mini VIDAS

The mini VIDAS software

Description

Ref.

1: Section labels

2: Section status

Available:

Barcode:

Error:

Offline:

Resetting:

There are two sections, labeled A and B.

The status of each section. The following status indicators are used:

The section is available to be assigned and run tests.

The mini VIDAS module is in the process of reading the bar codes of the reagent strips in the section.

Indicates a temperature control problem or a hardware problem in the section.

The section has been taken offline.

The section is in the process of a hardware reset and is not available. This status normally lasts for less than one minute.

Run:

2-16 mini VIDAS

The section is running tests.

When a section is running, the following additional information appears on the screen:

- Assay code of the assay in the section (it is not displayed if several tests are running in the same section).

- The estimated time of the day that the run is expected to finish.

Procedures Manual

Page 49

Parts of the mini VIDAS

The mini VIDAS software

Start error:

Starting:

Unload:

There is an error related to the preprocessing of a reagent strip. Press the <?> key to display the status of each position in the section.

Possible start errors are:

− Bad bar code: the mini VIDAS was unable to read the bar code on the

reagent strip. It must be entered manually.

− Bad substrate: the initial fluorescence reading of the substrate is not

acceptable. The reagent strip must be replaced.

− Incompatible: the assay in this position is not compatible with other assays in

the section. (the assay cannot be run at the same time as the others in the same section). The assay must be removed from the section and rerun with other tests with which it is compatible.

− Misaligned: a dual reagent strip has been placed in the wrong positions.

Dual reagent strips must be placed in positions 1 & 2, 3 & 4, or 5 & 6.

− No strip: a reagent strip was specified for this position but none was found.

− Unknown assay: there is no protocol stored in the mini VIDAS for the assay

type.

− Wrong type: the type of assay specified for this position differs from the one

found.

− No MLE card: the MLE card was not read for the assay.

− The reagent lot used has expired.

− Expired calibration: the validity date of the last calibration for this assay or lot

has expired.

− Unknown calibration: there is no calibration in the mini VIDAS for this assay

or lot and there are no calibrators in the job list.

The section has completed the preprocessing steps and is preparing to run tests.

The section is waiting for the SPR to be removed. This occurs at the completion of a run, and is accompanied by the blinking of the operating status light located over the SPR block door.

3 : The "•–" marker

4: Display temperature

mini VIDAS

Procedures Manual 2-17

Indicates that a selection key is active and that a section can be selected.

If you select this key, a screen is displayed showing the internal temperature of each reagent strip tray and SPR

block.

Page 50

Parts of the mini VIDAS

The mini VIDAS software

The second status screen

The second status screen is accessed by selecting one of the two sections on the first screen.

The purpose of the second status screen is to display the tests you have assigned to each position within the section.

The following figure shows a second status screen after all six positions have been assigned.

Fig. 2-17: Second status screen

Ref. Description

1: Screen label

2: Position numbers

3: Assay code

4: Standards, control

5: Start

halt:

This label shows you are looking at the status of section B.

These numbers identify the six positions in the section.

These codes appear as tests are assigned to the section or after the strip's bar code has been read.

If a position is assigned to a standard or control, this type of designator appears.

A selection option to start processing. In other circumstances, this selection may have another function.

This function appears while the section is processing. Use it to halt the processing.

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Parts of the mini VIDAS

The mini VIDAS software

The third status screen

The third status screen is accessed by selecting [Display temperatures] from the first status screen.

The purpose of this screen is to inform you of the operating temperature of the SPR

block and the reagent strip tray compartment of each section.

The figure below shows a typical third status screen.

Description

Ref.

1: Screen label

2: Reagent strip tray

column

3: SPR column

4: Sections

5: Print

This label shows you are looking at the Temperatures screen.

This column shows the temperature of the tray compartment for each section.

This column shows the temperature of the SPR block for each section.

These rows show the section A or B.

This selection allows you to print a copy of the temperature screen.

Fig. 2-18: Third status screen

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Procedures Manual 2-19

Page 52

Parts of the mini VIDAS

The mini VIDAS software

Online help

You can display information on the menu or program you are using by accessing the online help function.

Pressing the If you press the <?> key a second time, the following screen appears:

<?> key on the keypad activates this function.

Fig. 2-19: Help mode screen

Print Screen:

Information:

System Status:

compatibility

Assay

list:

The help mode screen provides the following functions:

Creates a printout of the screen from which you accessed the help function.

Displays the first help screen.

Displays the current date/time and the instrument status.

Displays a list of the mini VIDAS assay codes classified according to compatibility. Compatible assays are assays with the same protocol = assays which can be run simultaneously in the same section.

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Parts of the mini VIDAS

The mini VIDAS software

Viewing error messages

The <?> key also functions to display error messages. Should something happen on your mini VIDAS that requires your attention, the

mini VIDAS will start to beep. When you press the

message. The following figure is one example of the type of display you see:

<?> key in this mode, the screen displays an error

Screen paging

Using the arrow keys

Some of the displays in the mini VIDAS are too long for one screen. In these cases you can page the screen display using the keys. The following figure, showing the Configuration Menu, illustrates this function:

<↑> and <↓> arrow

• Note the arrow on the screen.

∗ To display additional items,

• Press the <↓> arrow key.

∗ After the <↓> arrow key is pressed, another arrow appears at the top of the

display, indicating that you can use the

<↑> arrow key to page the display back.

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Procedures Manual 2-21

Page 54

Parts of the mini VIDAS

The mini VIDAS software

Paging bar

Some mini VIDAS screens have what is called a paging bar, as illustrated in the following figure:

A paging bar is generally used for displays that require several screens.

As you page down to the last page, the solid bar moves down the slot.

Its position is relative to your position within the possible pages.

The next page of this display would be similar to the following figure:

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Parts of the mini VIDAS

The mini VIDAS software

Memory cards

A memory card is a storage device for software, similar to the more familiar floppy disks.

The mini VIDAS uses this type of device because of its small size and convenience.

Should the software for your mini VIDAS be updated, bioMérieux you a program update memory card.

This card remains the property of bioMérieux SA. It should be returned to bioMérieux SA after your instrument has been upgraded.

A special program takes the software from this card and places it in the mini VIDAS's internal memory for permanent storage.



SA will send

IMPORTANT! Memory cards:

- must be protected from humidity, extreme temperatures, direct sunlight, and strong magnetic fields.

- must not be subjected to flexing,

- must not be subjected to severe impacts.

mini VIDAS

Procedures Manual 2-23

Page 56

Parts of the mini VIDAS

The assay kit

Single reagent strip

Each mini VIDAS assay kit provides the materials required to run a specific assay.

The materials vary for each assay, but generally a kit contains:

− single or dual reagent strips,

− SPRs (Solid Phase Receptacle):

. one per single reagent strip, . two per dual reagent strip

− control(s)

− the necessary standard(s)

− a diluent, if required,

− a package insert,

− an MLE card.

The mini VIDAS single reagent strip has ten wells. The sample is placed in the sample well.

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

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

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

Fig. 2-20: Single reagent strip

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Tab

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Parts of the mini VIDAS

The assay kit

Dual reagent strip

Some assays use a dual reagent strip, two strips attached side by side.

The sample is equally divided between the two sample wells of the dual reagent strip.

With the strip oriented as shown in figure 2-21, the strip on the top is the sample reference strip. The one on the bottom is the sample test strip.

The dual reagent strip configuration is used to compensate for sample variability.

The sample test strip contains a reagent that is not included in the sample reference strip. Measurements taken from both strips are used to determine the test result.

Dual strips fit in the reagent strip tray exactly like single strips, but they require two channels.

The label

Fig. 2-21: Dual reagent strip

Each mini VIDAS reagent strip has a label, a colored dot and the assay code (2 or 4 letters/digits).

The color-coded dot corresponds to a matching dot on the test's companion SPR. The bar code identifies:

− the assay name,

− the manufacturing batch code,

− the sequence number,

− the expiration date of the test kit for the mini VIDAS.

The figure below represents a typical label:

② ③ ⑤ ⑥ ⑦

④ ①

Fig. 2-22: Reagent strip label

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Procedures Manual 2-25

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Parts of the mini VIDAS

The assay kit

Ref. Description

1: Bar codes

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

2: Alphanumeric representation of the bar code

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

3: Assay name The assay code is based on two or four characters and/or figures which

represent the name of the assay to be performed;

Examples:

RBG RUB IgG (Immunoassay)

153 CA 15-3

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

4: ID A blank space is provided to write the sample ID (if required).

5: Batch code The Batch code is used by the mini VIDAS to code the expiration date of the

reagent lot.

6: Expiration date This corresponds to the expiration date of the reagent lot. When the bar code

reader reads this date, the mini VIDAS compares it to the date stored in its memory to ensure that the lot has not passed its expiration date.

7: Sequence Number Within a single batch, each reagent tray carries a different number

corresponding to the order of manufacture.

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Parts of the mini VIDAS

The assay kit

The SPR

The Solid Phase Receptacle, or SPR (pronounced “spur”), is a specially designed plastic pipette-shaped device.

During manufacturing, the interior of the SPR other treatments that capture a target analyte.

Each SPR both are coded with matching color dots and assay code.

It is critical that SPRs be paired only with strips that have matching dots, otherwise the test result will be invalid.

The figure below shows a typical SPR.

has a corresponding mini VIDAS reagent strip included in the test kit;

is coated with antibody, antigen, or

Fig. 2-23: Solid phase receptacle (SPR)

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Procedures Manual 2-27

Page 60

Parts of the mini VIDAS

The assay kit

How the SPR functions

The SPR block is part of an automated pipetting system that uses the SPRs to mix and transfer reagents during processing.

The mini VIDAS uses the SPR to withdraw or dispense liquid from or to a well in the reagent strip.

The beveled tip of the SPR enables it to pierce the protective seal that covers the wells in a reagent strip.

The reagent strip tray then moves in and out to allow liquids to be transferred from one well to another.

The mini VIDAS uses the SPR to accomplish all the required processing steps, including:

− sampling,

− incubation,

− mixing,

− washing.

The sample is drawn into and out of the SPR. The target analyte from the sample binds to the SPR's interior coating (antibody,

antigen, etc.). Various washes remove unbound and interfering substances. The target analyte is labeled by an enzyme-conjugated antibody or antigen,

forming a "sandwich". The immobilized enzyme catalyzes the breakdown of the substrate into a

fluorescent end product. The optical scanner obtains fluorescence readings of the substrate material and

transmits the measurement to the central processing unit for analysis.

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Page 61

3 Getting started

Introduction

This chapter covers the very first steps you need to take before you can use the

mini VIDAS.

The following procedures are described in this chapter:

♦ Aim / Description........................................................................................ 3-2

♦ Precautions for installation and use ........................................................... 3-3

♦ Unpacking the mini VIDAS......................................................................... 3-5

♦ Starting the mini VIDAS .............................................................................3-7

♦ Shutting down the mini VIDAS ................................................................. 3-10

♦ Configuring the mini VIDAS ..................................................................... 3-11

♦ Installing paper in the printer.................................................................... 3-38

♦ Print screen.............................................................................................. 3-40

mini VIDAS® Procedures Manual 3-1

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Getting started

Aim / Description

mini VIDAS is a compact, multiparametric, automated immunoanalyzer.

∗ Automated immunoanalyzer

After the samples have been dispensed by the user, the mini VIDAS automatically performs the different stages of analysis, including the printing of reports.

The software processes the reagents using their bar codes and can send the mini VIDAS results to a Laboratory Information System (uni-directional interface). The bar code labels on the sample tubes can be read using an independent bar code reader (optional).

The mini VIDAS has a built-in system for detecting and reporting errors. Its unique design enables it to operate around the clock and daily start-up is completed in a few seconds.

∗ Compact

The mini VIDAS is a completely self-contained unit that includes:

− an analytical module,

(12 test positions i.e. two 6-test sections) and,

− data processing equipment (monitor, keypad, printer).

∗ Multiparametric

The mini VIDAS enables 10 different analytes to be used simultaneously and up to 30 results can be produced per hour.

∗ Immunoassays

The mini VIDAS is used with VIDAS assay kits covering numerous immunoassay * fields:

− hepatitis,

− AIDS,

− serology testing,

− bacterial and viral antigen detection,

− fertility/pregnancy monitoring,

− thyroid hormones,

− allergies,

− tumor markers,

− endocrinology,

− anemia,

− cardiovascular diseases,

− therapeutic drug monitoring,

− immuno-hemostasis,

− industrial microbiology.

The availability of certain VIDAS tests may be restricted in some countries, depending on registration release dates.

Contact your local sales representative for details.

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Page 63

Getting started

Precautions for installation and use

CAUTION! Before unpacking the instruments, it is advisable to have previously

planned where they will be placed.

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

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

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

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

Only power cords and accessories supplied by bioMérieux used to connect the instruments.

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

Computer cables must not intersect or be placed too close to cables for connection of the power supply.

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

All connections should be performed with the power OFF.

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

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

- diameter of cables,

- grounding,

- protection through circuit breaker and/or use of fuse,

- connector calibration and type etc.

sa should be

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Procedures Manual 3-3

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Getting started

Precautions for installation and use

The electrical power supply must be:

- direct,

- individual,

- calibrated,

- protected,

- compatible with the technical specifications of the product or

configuration.

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

Extension sockets and serially connected adapters should not be used.

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

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

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

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

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

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

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

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Getting started

Unpacking the mini VIDAS

Preparations before unpacking

Step 1

Step 2

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

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

∗ Make sure that all the items in the packing list have been delivered. ∗ Make sure that no damage has been caused during transportation. ∗ The instrument must be placed on a flat surface with a maximum horizontality

defect of 5°.

Note: See Appendix A for a complete listing of mini VIDAS specifications.

Note: Retain the shipping box and packing materials in case you need to ship the mini VIDAS at

CAUTION! The mini VIDAS blue weighs 40 kg (88 lb).

CAUTION! The mini VIDAS blue should be lifted or moved using the gripping area

• Place the box containing the mini VIDAS on the floor and open the top of

the shipping box.

a later date.

• Remove the instrument from the shipping box and place it on the floor.

The mini VIDAS weighs 37 kg (81.5 lb). Two people should lift it out of its box and place it on the benchtop.

located on its base.

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Procedures Manual 3-5

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Getting started

Unpacking the mini VIDAS

Step 3

Step 4

Step 5

Step 6

• Remove the foam end caps and the antistatic bag. (see Note in Step 1

above).

• Place the instrument on the benchtop.

• Remove the tape securing the dust covers. (See the figure below).

Dust covers

Fig. 3-1: mini VIDAS dust covers

• Open each dust cover.

• Remove the shipping block (See Note in Step 1

Note: The shipping block in Section A (on the left as you face the instrument) has a rod attached

to it. This rod secures the optical scan head during shipment and must be removed with the shipping block.

above).

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Getting started

Starting the mini VIDAS

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

Note: All software required for the mini VIDAS has been loaded into the mini VIDAS. Follow

Step 1

Note: See Appendix A for mini VIDAS power specifications.

Step 2

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

After opening, if it is imperative to switch the instrument on, any adjustment, servicing or repair should be performed by a qualified technician, well aware of the possible risks.

During a storm, never connect cables to the keyboards, screens, printer or telephones, or lightning conductors to the transmission lines.

these steps to start your mini VIDAS.

• Connect the power cord to the mini VIDAS and an appropriate power outlet.

• Reach behind the instrument and turn the power on (see figure below).

mini VIDAS

ON/OFF switch and power outlet

Fig. 3-2: Power switch

CAUTION! The power switch is located on the back of the analytical module. It must

be easy to reach at all times.

Procedures Manual 3-7

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Getting started

Starting the mini VIDAS

Allow the mini VIDAS to warm up for 45 minutes. During initialization, the

•

optical system automatically calibrates against a standard which reacts to temperature.

• Put the "ON/OFF" switch on the analytical module in the "OFF" position.

• Wait 1 minute and put the switch back in the "ON" position. This operation

enables the standard value to be memorized after the temperature has stabilized.

This procedure involves the following:

− Software self test and diagnostics.

This part of the sequence is not noticeable.

− Hardware self test.

The mini VIDAS tests all its motors. Expect to hear noises inside the instrument and to see the reagent strip trays (under the dust covers) retract into the instrument.

− Software boot sequence.

The boot sequence is a program that loads the mini VIDAS software into its memory.

∗ During this sequence, expect to see the following messages on the display

screen:

Booting Initializing... Please Wait

The mini VIDAS may be left on 24 hours a day for three reasons:

− to avoid problems when it is turned on,

− to avoid incorrect auto-calibration,

− to enable the temperature of electrical components to remain stable

The mini VIDAS can therefore be used at any time during the day.

Note: If the room temperature is too low when the mini VIDAS is turned on, error 160 will be

3-8 mini VIDAS

generated after the initialization phase or when the instrument is restarted. After complete reinitialization, turn off the mini VIDAS and then turn it back on again. If error 160 persists, call bioMérieux

Technical Assistance.

Procedures Manual

Page 69

Getting started

Starting the mini VIDAS

∗ The first time that power is applied to your mini-VIDAS, the language selection

screen appears:

Step 3

Step 4

• Press the <↑> or <↓> keys, as needed, until the language you want appears

on the screen

• Select the language you want to use.

This completes the initial startup sequence and brings up the mini VIDAS Main Menu:

mini VIDAS

Procedures Manual 3-9

Page 70

Getting started

Shutting down the mini VIDAS

∗ If the mini VIDAS has been shut down for an extended period of time, wait for

45 minutes

it can autocalibrate at 37°C.

Note: The "park system" procedure should only be performed when the mini VIDAS has to be

transported (see page 6-25).

after switching it on again, then turn it off and on once more so that

∗ When the mini VIDAS is shut down the following are stored in memory:

− the software,

− the protocols,

− the configuration,

− the results of the last two calibrations per assay,

− Master Lot Data.

∗ The following are erased:

− assay results (except calibration results),

− error messages.

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Getting started

Configuring the mini VIDAS

CAUTION! Configuration parameters should only be modified by trained and qualified

personnel. Any modification to configuration parameters may lead to problems when the system is used or cause it to operate in an unexpected manner. Make sure that modifications are necessary and justified.

The procedures in this section are accessed from the Configuration Menu. Proceed as follows to reach the Configuration Menu:

Main Menu

Utility Menu

mini VIDAS

Configuration Menu

Fig. 3-3: Accessing the Configuration Menu

Procedures Manual 3-11

Page 72

Getting started

Configuring the mini VIDAS

Setting dose units

Step 1

∗

This option is used to set the standard units applicable to results for the quantitative mini VIDAS assays.

In the Configuration Menu (see page 3-11 for accessing this menu),

• Select [Set Dose Units].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

An assay selection list, similar to the following, appears:

Step 2

(optional)

Note: If the [Configuration Menu] , [Misc], [Show all assays]functions are not

• Press the <↓> or <↑> keys, as needed, until the assay you want appears on

the screen.

activated,

only the tests whose MLE card has been read will be displayed.

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Getting started

Configuring the mini VIDAS

Step 3

• Select an assay whose dose units you want to set.

A screen similar to the following appears:

Note 1 : The dose unit currently set is indicated by an arrow.

Note 2 : For certain assays, a second screen may appear (similar to the one in Step 1) for

Step 4

Step 5 This step has two options:

selection of a "sub-assay".

• Select the dose unit desired for this assay.

The display returns to the Configuration Menu.

∗ Select another assay to set the dose units. ∗ Repeat steps 1 - 4.

• Press <Previous Screen> to return to the Configuration Menu.

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Procedures Manual 3-13

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Getting started

Configuring the mini VIDAS

Setting user ID

∗ Set the user IDs (up to nine). When you start assays in a section, you are asked

∗ The user is automatically identified on all reports. ∗ If you do not set a user ID, the user field is left blank on the reports.

Step 1 ∗

This option is used to enter an ID for those who will be using the mini VIDAS. These IDs appear on the assay report.

How you use this configuration option affects the operation of the mini VIDAS in the following ways:

to select a user ID from the group you create here.

− If both sections are started together, one user is identified.

− If the sections are started separately, two users can be identified.

In the Configuration Menu (see page 3-11 for accessing this menu),

• Select [User ID].

The Set User ID screen appears:

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Getting started

Configuring the mini VIDAS

Step 2

• Press a digit, 1 - 9, on the <Number Key> pad, corresponding to the first

through the ninth user entered. The User ID screen appears:

"Z" character can be used to create a space in your ID.

Step 3

Step 4

Step 5

The space next to the

• Press the <↑>, <↓>, <←> and <→> keys to highlight the appropriate

character in the character box.

• Validate this character by pressing the selection key.

The character appears in the cursor box.

• Repeat steps 3 and 4 to create an ID of up to 10 characters.

• Use these functions as required:

[Clr] to clear the cursor box. [←] to delete one character in front of the cursor.

Step 6

Step 7 This step has two options:

• Press <Previous Screen> to return to the Set User ID screen.

∗ To enter another user,

• Repeat steps 2 - 6.

mini VIDAS

∗ To return to the Configuration Menu,

• Press the <Previous Screen> key.

Procedures Manual 3-15

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Getting started

Configuring the mini VIDAS

Setting the report header

This option is used to define a line of up to 32 characters. This line appears in the header information of the assay report.

Step 1 ∗

In the Configuration Menu (see page 3-11 for accessing this menu),

• Select [Report Header].

• Press the <↑> and <↓> keys until the submenu you want appears on the

The Header screen appears:

screen.

Step 2

Step 3

Step 4

Step 5

The space next to the "Z" character can be used to create a space in your header.

• Press the <↑>, <↓>, <←> and <→> keys to highlight the appropriate

character in the character box.

• Validate this character by pressing the selection key.

The character appears in the cursor box.

• Repeat steps 2 and 3 to create a report header of up to 32 characters.

• Use these functions as required:

[Clr] to clear the cursor box. [←] to delete one character in front of the cursor.

Note: The display shows a maximum of 14 characters. If the report header created is longer, the

symbol "<" will appear first followed by the last 14 characters.

∗

To return to the Configuration Menu,

• Press the <Previous Screen> key.

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Getting started

Configuring the mini VIDAS

Setting the date and time

This option is used to set the date and time for the mini VIDAS. These values appear on the assay report and all other places in the software where the date or time of day is used.

Step 1

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

programs and loss of data.

In the Configuration Menu (see page 3-11 for accessing this menu),

∗

• Select [Set Date/Time].

The following screen appears:

Step 2

Step 3

• Set the date and time using the following functions:

[Clr] to clear the cursor box. [←] to delete one character in front of the cursor.

<Number Keypad> pad to fill in the numerical value for a day, month, year,

hour or minute.

Note: Use the <ENTER> key to validate the numerical values.

∗

To return to the Configuration Menu,

• Press the <Previous Screen> key.

mini VIDAS

Procedures Manual 3-17

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Getting started

Configuring the mini VIDAS

Setting display contrast

The liquid crystal display on the mini VIDAS has a contrast adjustment to allow for proper viewing in different room lighting conditions.

Use this procedure to adjust the contrast.

CAUTION! Too much contrast could reduce the life span of your monitor. It is

recommended that you use your mini VIDAS for several days with the original setting before modifying the contrast.

Step 1

In the Configuration Menu (see page 3-11 for accessing this menu),

∗

• Select [Set Display Contrast].

Step 2 The following screen appears:

Step 3

∗

To adjust the contrast,

• Press the <↑> or <↓> key.

The contrast bar and relative contrast level (number in the box) go up or down in response to your adjustments.

Step 4

(optional)

Step 5

The actual display contrast also changes as you make the adjustments.

∗

To go back to the default setting,

• Press the <UNDO> key.

∗

To return to the Configuration Menu,

• Press the <Previous Screen> key.

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Getting started

Configuring the mini VIDAS

Selecting the printer

∗ With this option you can select the internal thermal printer, or an external matrix

parallel printer.

Step 1 ∗

In the Configuration Menu,

• Select [Select Printer].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 The following selections appear:

Step 3

Step 4

Note: A ⌧ symbol indicates the current setting.

IMPORTANT! Before selecting an external printer, see Appendix D for external printer

∗

[Internal Printer] [External Printer]

• Select the printer you want to use.

installation instructions.

To return to the Configuration Menu,

• Press the <Previous Screen> key.

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Procedures Manual 3-19

Page 80

Getting started

Configuring the mini VIDAS

Setting the date/time format

∗ To set the format of the date and time used on the reports,

• Use this option.

Step 1 ∗

In the Configuration Menu,

• Select [Set Date/Time Format].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 The Date/Time format screen appears:

Note: If you do not want to change the current time separator,

• Go to Step 5.

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Getting started

Configuring the mini VIDAS

Step 3

Step 4

Step 5

Step 6

Note: If you do not want to change the current date separator,

Note: If you do not want to change the current date/time format,

• Select [Time Separator] on the Date/Time Format screen

The following selections appear:

[:] (colon) [.] (period) [,] (comma)

• Select a time separator.

The display automatically returns to the Date/Time format screen.

• Go to Step 7.

• Select [Date Separator] on the Date/Time format screen.

The following selections appear:

[/] (slash) [-] (dash) [.] (period)

• Select a date separator.

The display automatically returns to the Date/Time format screen.

• Go to Step 9.

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Step 7

∗ To display the selection [HH.MM dd.mm.yy],

Note: The date and time separators used in this display are those that you selected in Step 5

Step 8

Step 9

∗

• Select [Format] on the Date/Time format screen.

The following selections appear:

[HH.MM ddmmm] [HH.MM ddmmmyy] [HH.MM yy.mm.dd] [HH.MM.SS ddmmmyy] [HH.MM mm.dd.yy]

• Press the <↓> key.

above.

• Select a date/time format.

The display automatically returns to the Date/Time format screen.

To return to the Configuration Menu,

• Press the <Previous Screen> key.

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Configuring the mini VIDAS

Defining the sample ID character sets

This option enables you to define two separate three-character ID sets. Use one or both of these sets to input repetitive characters for sample IDs.

In the Configuration Menu,

Step 1

∗

• Select [Define Sample ID Character Sets].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 The following selections appear:

[Sample ID Set 1] [Sample ID Set 2]

Step 3

• Select one of the two character sets to define. The following screen

appears:

The space next to the set.

"Z" character can be used to create a space in your ID

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Step 4

∗

To highlight the appropriate character in the character box,

• Press the <↑>, <↓>, <←> and <→> keys.

Step 5

Step 6

Step 7 This step has two options:

• Validate this character by pressing the selection key.

It then appears in the cursor box.

• Repeat Steps 4 and 5 to add up to three additional characters to the ID.

Use these functions as needed:

[Clr] to clear the cursor box. [←] to delete one character in front of the cursor.

∗ If you have finished defining sample ID character sets,

• Press the <Previous Screen> key two times to exit to the Configuration

Menu.

∗ If you want do define the other ID character set,

• Press the <Previous Screen> key once and return to Step 3.

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Changing the keyclick volume

When you press any key on the keypad, there is an audible tone that confirms the keystroke.

Use this procedure to change the volume of that tone.

In the configuration Menu,

Step 1

∗

• Select [Sound Menu].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2

• Select [Keyclick Volume] in the Sound Menu.

The following screen appears:

Step 3 ∗

Step 4

(optional)

Step 5 ∗

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∗

To adjust the keyclick volume,

• Press the <↑> and <↓> keys.

The volume bar and relative volume level (number in the box) go up or down in response to your adjustments.

To go back to the default setting,

• Press the <UNDO> key.

To return to the Sound Menu,

• Press the <Previous Screen> key.

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Changing the beep volume

The beep is the tone you hear when you press a key that is inactive (it should not be pressed on the particular screen you are viewing).

Use this procedure to change the volume of that tone.

In the Configuration Menu,

Step 1

∗

• Select [Sound Menu].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2

• Select [Beep Volume].

The following screen appears:

Step 3 ∗

To adjust the beep volume,

• Press the <↑> and <↓> keys.

The volume bar and relative volume level (number in the box) go up or down in response to your adjustments.

Step 4 ∗

(optional)

Step 5

(optional)

Step 6

3-26 mini VIDAS

To go back to the default setting,

• Press the <UNDO> key.

∗

To hear the tone at the adjusted volume,

• Select [Test].

∗

To return to the Sound Menu,

• Press the <Previous Screen> key.

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Error beeps

∗ When an error occurs, the mini VIDAS begins to beep. The beep grows louder

over a 5 minute period. You can set the initial and final volume of this error beep.

Setting initial error volume

Step 1 ∗

Step 2

Step 3

Step 4

(optional)

Step 5

(optional)

Step 6

In the Configuration Menu,

• Select [Sound Menu].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

• Select [Initial Error Volume] in the Sound Menu.

The following screen appears:

∗

To adjust the initial error beep volume,

• Press the <↑> and <↓> keys.

The volume bar and relative volume level (number in the box) go up or down in response to your adjustments.

∗

To go back to the default setting,

• Press the <UNDO> key.

∗

To hear the tone at the adjusted volume,

• Select [Test].

∗

To return to the Sound Menu,

• Press the <Previous Screen> key.

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Setting the final error volume

Step 1

In the Configuration Menu,

∗

• Select [Sound Menu].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2

• Select [Final Error Volume] in the Sound Menu.

The following screen appears:

Step 3

∗

To modify the final error beep volume.

• Press the <↑> and <↓> keys.

The volume bar and relative volume level (number in the box) go up or down in response to your adjustments.

Step 4

(optional)

Step 5

(optional)

Step 6

∗

To hear the tone at the adjusted volume,

• Select [Test].

∗

To go back to the default setting,

• Press the <UNDO> key.

∗

To return to the Sound Menu,

• Press the <Previous Screen> key.

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Enabling display blinking

While not a sound function per se, display blinking is associated with the error beep since it only occurs during an error condition.

Step 1

Use this procedure to enable or disable the display blinking function. When enabled, it causes the display to blink (flash on and off) when an error

occurs.

In the Configuration Menu,

∗

• Select [Sound Menu].

• Press the <↑> and <↓> keys until the submenu you want appears on the

Step 2

screen.

∗

To select [Display Blinking] in the Sound Menu,

• Press the <↓> key once.

The following selections appear on the screen:

Blinking on

Note: The current condition of this function is denoted by an arrow "→" in the selection box.

Blinking off

Step 3

mini VIDAS

• Indicate your choice by selecting the appropriate key. The display returns to

the Sound Menu.

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Configuring the mini VIDAS

Miscellaneous items

Note: In the default configuration, all of the miscellaneous options are enabled except the two

Step 1

∗

This option is used to configure various warnings concerning Master Lot data and standards.

for:

- Expired Standard Printed Warnings,

- Autoprint Errors.

In the Configuration Menu,

• Select [Misc Items].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 A screen similar to the following appears:

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Step 3 This step has seven options:

Note: A  symbol indicates an enabled option. Each option is independent. This is why more

than one option can be selected. The  symbol is removed when you disable a selected option.

∗ Select [Expired Standard - Onscreen warnings].

The mini VIDAS automatically checks for expired calibrations. This procedure is performed every 24 hours or when the mini VIDAS is started up. If there are any expired calibrations, an error message is displayed and printed (printing can be configured).

Note: See chapter 7 "Error handling" for more information on error messages.

∗ Select [Expired Standard - Printed warnings].

Note: See chapter 7 "Error handling" for more information on error messages.

∗ Select [Autoprint Errors].

The mini VIDAS will generate a printout when an error occurs. You will still need to view the error on screen to stop the blinking and beeping.

Note: See chapter 7 "Error handling" for more information on error messages.

If you do not select this option, messages are printed only after the operator acknowledges the error.

• Press the <↓> key.

The following screen appears:

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Step 3 (cont'd)

∗ Select [Check for ANY Standard at assay startup].

Note: See chapter 7 "Error handling" for more information on error messages.

∗ Select [Check for Current Standard at assay startup].

Note: See chapter 7 "Error handling" for more information on error messages.

The mini VIDAS generates a startup error only when no standard, current or expired, exists for the selected assay. If an expired standard exists, the assay will start.

The mini VIDAS generates a startup error if there are no current standards for the selected assay.

• Press the <↓> key once more.

The following screen appears:

∗ Select [Check for Master Lot at assay startup].

The mini VIDAS generates a startup error when there is no Master Lot data for the selected assay.

Note: See chapter 7 "Error handling" for more information on error messages.

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∗ Select [Show all assays].

The mini VIDAS will include all of the assays it is capable of running when it displays an assay selection list.

To display only the assays for which Master Lot data have been entered,

Note: A change to this option does not take effect until the mini VIDAS is rebooted.

• Deselect [Show all assays].

Only the assays for which Master Lot data have been entered will be displayed.

• Press the <↓> key once more.

The following screen appears:

Step 4

• Select [Beep After Printing].

The mini VIDAS will beep discontinuously for a few seconds each time it generates a printout.

To return to the Configuration Menu,

∗

• Press the <Previous Screen> key.

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LIS user options

CAUTION! Your unidirectional connection must be configured and brought into

Step 1

∗

This option is used if your mini VIDAS is connected to a Laboratory Information System (LIS). Before results can be sent to the LIS, the LIS upload function must be enabled. This option is also used to validate results before they are transmitted to the LIS.

service by trained and qualified personnel. Any modification may lead to problems when the connection is used or cause it to operate in an unexpected manner.

In the Configuration Menu (see page 3-11 for accessing this menu),

• Select [LIS User Options].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 A screen similar to the following appears:

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Step 3

Note: A ⊠ symbol indicates a selected option. The ⊠ symbol is removed when you disable a

Step 4 This step is optional.

IMPORTANT! If you select [LIS upload Enabled], it is recommended that you also

Step 5

Step 6

• Select [LIS Upload Enabled].

This selection will activate the Laboratory Information System (LIS) upload feature.

selected option.

• Select [Warn About Missing IDs].

When this option is selected, assays are checked at assay startup.

If an assay does not have an ID, a warning message is generated.

Acknowledging the message allows the assay to continue. You can then add an ID to the assay.

If this option is not selected, no ID warning messages are generated.

select [Warn About Missing IDs] since any results without IDs will not be transmitted to the LIS.

If you want uploading to be automatic,

∗

• Select [LIS auto validation].

∗

To return to the Main Menu,

• Press <ENTER> twice.

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Configuring the mini VIDAS

Creating normal ranges for assays

You can create up to 8 lines of free text for any mini VIDAS assay. These lines, each with up to 36 characters, are printed at the bottom of each

Step 1

report for the particular assay type.

In the Configuration Menu (see page 3-11 for accessing this menu),

∗

• Select [Normal Ranges].

• Press the <↑> and <↓> keys until the submenu you want appears on the

screen.

Step 2 An assay selection screen appears:

The assays that actually appear may be limited by the [Show All Assays]

Step 3

(optional) This step is optional.

configuration option.

• Press the <↓> or <↑> key until the assay you want appears on the screen.

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Step 4

• Select an assay whose normal ranges you want to create.

The following screen appears:

Step 5 ∗

The [1 / 1] in the upper left portion of the display tells you that this screen is for Line #1 of 1 total lines.

These numbers change as you access the screens for other lines.

To highlight the appropriate character in the character box,

• Press the <↓>, <↑>, <←>or <→> key.

Step 6

The space next to the "Z" character can be used to create a space in your text.

For the character box to select the character,

∗

• Press the selection key.

Step 7

The selected character then appears in the cursor box.

To add up to 36 characters,

∗

• Repeat steps 5 and 6.

Use these functions as needed: [Clr] to clear the cursor box.

Step 8 This step is optional.

[←] to delete one character in front of the cursor. [Prev.] to switch to the screen for the previous line of text.

To switch to the screen for the next line of text,

• Press <ENTER>.

To enter up to eight lines of text,

• Repeat steps 5 to 7.

Step 9

To return to the Configuration Menu,

∗

• Press the <Previous Screen> key.

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Getting started

Installing paper in the printer

Use this procedure to load paper in the internal thermal printer.

Note: The paper for this printer is coated on only one side. If the printer does not print after the

paper is installed, reorient the roll to expose the other side.

Step 1

Step 2

Step 3

Step 4

• Select [Utility Menu] on the Main Menu.

• Select [Misc. Functions] on the Utility Menu.

The miscellaneous functions menu appears:

• Select [Load Printer].

The following message appears:

Load paper now

(Press any key to quit)

• Lift the printer door, located on the top of the instrument, above the keypad.

Step 5

Note: If you have just unpacked the mini VIDAS, there may be a piece of tape holding the

Step 6

Step 7

3-38 mini VIDAS

• Retrieve the paper spindle from its slots and put it through the core of the

paper roll.

spindle. Remove and discard this tape.

• Return the loaded spindle to the vertical slots in the print roll housing.

The paper engagement lever is in the LOWER end of its slot.

• Push the edge of the paper under the paper feed roller.

A sensor that detects the presence of the paper activates the paper roller.

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Installing paper in the printer

Step 8

• Allow the roller to feed the paper.

It stops automatically after a few seconds.

• Slide the paper engagement lever to the UPPER end of its slot.

Step 9

IMPORTANT! The paper must be fed enough so that the leading edge extends under the

plastic paper guide and out of the printer compartment so that it is exposed when you close the printer door. If necessary, select [Load Printer

] again to feed more paper.

• Hold the leading edge of the paper in one hand.

• With the other hand, close the printer door.

Your mini VIDAS is now ready for use!

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Print screen

• Display the page you want to print.

• Press the key twice.

The following screen appears:

• Select [Print Screen] to start printing.

• Press the key to go back to the previous screen.

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Biomerieux mini Vidas User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

General Warnings

Table of contents

List of figures

Finding topics or procedures

Typographic conventions

The mini VIDAS keypad

Graphic symbols

The mini VIDAS hardware

Possibilities of extension

The mini VIDAS software

The assay kit

3 Getting started

Aim / Description

Precautions for installation and use

Unpacking the mini VIDAS

Starting the mini VIDAS

Shutting down the mini VIDAS

Configuring the mini VIDAS

Installing paper in the printer

Print screen