VIDAS Users Manual Ver B Dec 2005

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

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

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

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

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

United Kingdom bioMérieux UK Ltd Grafton Way, Basingstoke Hampshire RG22 6HY tel. (44) 1256 461881 fax (44) 1256 816863

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

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

Poland bioMérieux Polska Sp. Z.o.o. ul. Zeromskiego 17 01-882 Warszawa tel. (48) 22 569 85 00 fax (48) 22 569 85 54 Portugal bioMérieux Portugal, Lda. Rua Alto do Montijo, Lotes 1 e 2 - Portela de Carnaxide 2794-070 Carnaxide tel. (351) 21 424 59 80 fax (351) 21 418 32 67 Russia o.o.o. bioMérieux Petrovsko-Razoumovskii proyezd, 29 127287 Moscow tel. (7) 095 212 10 26 / 095 424 79 38 fax (7) 095 214 95 41

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 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

Distribution in over 130 countries

Vietnam Representation office bioMérieux Vietnam Rep. Office 17 Nguyen Van Mai, Ward 8 District 3 Ho Chi Minh City tel. (84) 88 299 599 fax (84) 88 207 898

V.B 02/2005

This manual is periodically updated. The updates shall be included in the new releases of the Software. Information supplied in this manual may be subject to modifications before the products described become available. This manual may contain information or references relating to certain bioMérieux® SA products, software or services which are not available in the country of release; this shall not mean that bioMérieux SA intends to market such products, software or services in such country To request copies of publications or for any technical request, contact bioMérieux SA or your local distributor.

Liability disclaimer This manual is provided “AS IS” without any warranty, whether express or implied, of merchantability, safety, quality, accuracy, performance of products described on this manual, including an implied warranty of merchantability or fitness for a particular purpose, non infringement of third parties intellectual property rights and against an incidental or direct damage. In no event shall bioMérieux SA be liable for any direct or indirect damage or consequence related to, arising out of or in connection with, any use of this manual and/or its results by the User and/or any third party. In no event shall this manual be construed as an undertaking of bioMérieux SA, who reserves the right to modify this manual without notice and shall incur no liability as a result of such modification. This manual is provided for information purposes only and except for the present provisions does not constitute a binding document legally.

Intellectual Property bioMérieux SA is the sole owner of copyright, patrimonial rights and any other intellectual property rights in and to this manual and its content subject to possible third parties rights. This manual and its content are protected under the provisions of section L.111-1 and following articles of the French Intellectual Property Code and International Copyright and Author Rights Treaties. The rights to use this manual granted herein are non-exclusive and limited to the extent necessary to use the Software and Instrument. In no event shall the Users be granted herein any other right to use this manual including without limitation, the right to reproduce, represent, adapt or translate all or part of this manual by any mean whatsoever and in any country without the prior written consent of bioMérieux SA. Any use of this manual other than expressly permitted hereunder shall be prosecuted. IMPORTANT!

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

bioMérieux, the blue logo and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux SA or one of its subsidiaries. Windows is a used, pending and/or registered trademark belonging to Microsoft Corporation. Dacron is a used, pending and/or registered trademark belonging to Invista North America, SARL. 7X is a used, pending and/or registered trademark belonging to MP Biomedicals, LLC. Alconox and Liquinox are used, pending and/or registered trademarks belonging to Alconox, Inc.

V.B 02/2005

General Warnings

DANGER!

All biological fluids should be considered as potentially infectious. Protective gloves must be worn when manipulating blood, products derived from blood or objects contaminated with blood. Qualified laboratory personnel should use acceptable procedures for biohazardous material.

IMPORTANT!

The configuration that you have purchased is adapted to the legislation and standards of the different countries it will be sent to. For this reason, it may differ from the one presented in this document. ® However, it will not prevent VIDAS from operating correctly. This product is an in vitro diagnostic medical device. It complies with the directives and standards mentioned in the certificate supplied with it. The user is advised to read and understand all instructions in this manual to be able to derive the best performance from the VIDAS. bioMérieux SA recommends that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied. The accuracy of results obtained with this instrument depends, in particular, on the maintenance operations described in this manual. The user should be aware that, if the maintenance operations are not performed, are only partially performed, or are not performed as described in this manual, bioMérieux SA is in no case liable for any false test results obtained. bioMérieux SA is in no case liable for any changes made to the equipment without authorization from bioMérieux SA.

IMPORTANT!

Electromagnetic Compatibility (EMC): This is a Class A product. In a residential area, this product may cause harmful interference in which case the user may be required to take adequate measures at his own expense. The equipment may also cause inteference if not installed in accordance with the instructions given in this manual. This statement only applies to European countries and instruments symbol with regard to the waste electrical and electronic bearing the equipment European directive. You can play an important role in contributing to reuse, recycling and other forms of recovery of waste electrical and electronic equipment. Sorting this type of waste significantly reduces potential negative effects on the environment and human health as a result of the presence of hazardous substances in electrical and electronic equipment. At the end of the life cycle of this product, do not dispose of the product as unsorted municipal waste, even if it is decontaminated. It is imperative that you contact bioMérieux to assure for its appropriate disposal.

Revisions The list of revisions below summarizes replacements or additional pages in your VIDAS Instrument User’s Manual.

VIDAS® Instrument User's manual

Manual

Reason

Page(s)

V.A 03.2005

New VIDAS model

All

V.B 12.2005

New software version

All

Revisions-1

Table of Contents

1

How to use this manual

1-1

Finding topics and procedures ... 1-2 Typographic conventions ... 1-3 Warnings... 1-3 Graphic symbols ... 1-4 2

Functional description

2-1

Description / aim ... 2-3 Configuration components ... 2-4 Hardware... 2-6 Extension potential ... 2-11 Consumables ... 2-12 General features and technical specifications... 2-17 Environmental conditions ... 2-17 Physical features ... 2-18 Electrical specifications ... 2-19 Technical specifications ... 2-20 Temperature control ... 2-20 Characteristics of optical components... 2-21 Assay kit ... 2-21 Operating principles ... 2-22 Immunoassay methods ... 2-22 Protocol concept... 2-23 Optical system... 2-25 Performance checks / self-tests ... 2-26 Optical system... 2-26 Pipette mechanisms ... 2-28 VIDAS temperature ... 2-28 3

Getting started

3-1

Recommendations for installation and use ... 3-2 Unpacking the VIDAS ... 3-4 Assembly and installation ... 3-5 Choosing a location... 3-6 4

Starting the VIDAS

4-1

Switching on... 4-2 Installing the hand-held bar code reader... 4-3 Preliminary instructions ... 4-3 Preparing the computer... 4-4

VIDAS® Instrument User's manual

V-1

Table of Contents

Preparing the reader ... 4-8 Connecting the bar code reader ... 4-8 Configuring the bar code reader... 4-10 Recommendation for use of the bar code reader ... 4-11 5

Using VIDAS

5-1

Basic VIDAS work flow... 5-2 6

Maintenance

6-1

Preventive maintenance... 6-2 User maintenance ... 6-3 Tools required ... 6-3 Summary of maintenance operations... 6-4 Decontamination of the VIDAS blue... 6-5 Cleaning the strip preparation tray ... 6-8 Cleaning the reagent strip trays... 6-10 Cleaning the spill tray ... 6-12 Reassembling the strip preparation tray and switching the analytical module back on ... 6-13 Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706 ... 6-13 Decontamination of the VIDAS ... 6-14 ® Cleaning the SPR block... 6-15 Cleaning the reagent strip trays... 6-17 Cleaning the spill tray ... 6-18 Replacing the front panel and switching the analytical module back on ... 6-19 Using the reagent for testing the pipette mechanisms: Quality Control VIDAS (QCV) – Reference 30706 ... 6-19 Computer ... 6-20 Cleaning the screen ... 6-20 Printer ... 6-22 Cleaning ... 6-22 Replacing the ink cartridge ... 6-22 Bar code reader ... 6-22 Cleaning ... 6-22 7

Troubleshooting

7-1

8

Glossary

8-1

9

Index

9-1

Notes

V-2

VIDAS® Instrument User's manual

List of figures Functional description Fig. 2-1: VIDAS configuration ... 2-2 Fig. 2-2: Configuration components (example)... 2-4 Fig. 2-3: Reagent strip tray ... 2-7 Fig. 2-4: Strip preparation tray closed... 2-8 Fig. 2-5: Opening the strip preparation tray ... 2-8 Fig. 2-6: Reagent strips place on the strip preparation tray ... 2-8 Fig. 2-7: Reagent strips placed on the strip preparation tray with its boat ... 2-8 Fig. 2-8: SPR® block ... 2-9 Fig. 2-9: Optical cuvette on a reagent strip ... 2-10 Fig. 2-10: Single reagent strip... 2-12 Fig. 2-11: Dual reagent strip ... 2-13 Fig. 2-12: Reagent strip label... 2-14 Fig. 2-13: Reagent strip dot ... 2-14 Fig. 2-14: SPR® ... 2-16 Fig. 2-15: Dynamic reactions ... 2-23 Fig. 2-16: Example of a protocol... 2-24 Fig. 2-17: Fluorescent reading... 2-25

Getting started Fig. 3-1: Gripping area (only concerns VIDAS blue) ... 3-4

Starting the VIDAS Fig. 4-1: Power switch ... 4-2 Fig. 4-2 : Configuration options... 4-4 Fig. 4-3 : Configuration details... 4-5 Fig. 4-4 : Shutting down Windows® ... 4-7 Fig. 4-5 : Shutting down the computer ... 4-7 Fig. 4-6 : Example of a reader configuration sheet ... 4-10

Using VIDAS Fig. 5-1: Basic VIDAS work flow ... 5-2 Fig. 5-2: Basic VIDAS work flow (cont'd)... 5-3 VIDAS® Instrument User's manual

VI-1

List of figures

Maintenance Fig. 6-1: Opening the section fully ... 6-6 Fig. 6-2: Cleaning the SPR® block ... 6-7 Fig. 6-3: Cleaning the rear of the SPR® block... 6-7 Fig. 6-4: Do not clean the seals situated above the SPR® block ... 6-8 Fig. 6-5: Opening the strip preparation tray ... 6-8 Fig. 6-6: Cleaning the strip preparation tray... 6-9 Fig. 6-7: Dismantling the strip preparation tray ... 6-10 Fig. 6-8: Removing the strip preparation tray... 6-10 Fig. 6-9: Repositioning the strip sections trays ... 6-11 Fig. 6-10: Cleaning the spill tray ... 6-12 Fig. 6-11: Removing the front panel... 6-14 Fig. 6-12: Cleaning the SPR® block ... 6-15 Fig. 6-13: Cleaning the rear of the SPR® block... 6-16 Fig. 6-14: Do not clean the seals situated above the SPR® block... 6-16 Fig. 6-15: Repositioning the strip sections trays ... 6-17 Fig. 6-16: Cleaning the spill tray ... 6-18 Fig. 6-17: Replacing the front panel... 6-19 Fig. 6-18: Shutting down Windows®... 6-20 Fig. 6-19: Shutting down the computer ... 6-21 Note:

V-2

Software screens and figures are given for information purposes only.

VIDAS® Instrument User's manual

1

How to use this manual

Introduction This manual deals exclusively with the VIDAS equipment and consumables. The software and procedures for use are described in the VIDAS PC User's Manual. The table of contents lists all the chapters of this manual. Each chapter is subdivided into sections corresponding to a procedure or a precise description. Answers to questions can easily be found by referring to the table of contents, or the index at the back of this manual. WARNING!

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

VIDAS® Instrument User's manual

1-1

How to use this manual Finding topics and procedures

Finding topics and procedures This manual is divided into nine chapters. The first seven chapters are used for the description and procedures. Chapter 8 contains the glossary and chapter 9 the index.

Table of contents

The main table of contents of the manual is located on pages V-1 to V-2. It lists each chapter and the procedures and/or topics contained in the manual.

List of figures

Page VI-1 contains a list of the figures in this manual.

Graphic symbols

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

Page headers page footers

and

Apart from the first page of every chapter, each page of this 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.

Glossary

The glossary is located in chapter 8 at the back of the manual. It gives the definition of the main technical terms used in the manual.

Index

The index is located in chapter 9 at the back of the manual. It is used to locate a particular description or procedure.

Sheet of decontamination labels

One of these labels is applied to the equipment to certify that it has been properly decontaminated:

1-2

− −

before any operation by a service technician, before it is returned to the factory, if necessary.

VIDAS® Instrument User's manual

How to use this manual Typographic conventions

Typographic conventions The following typographic conventions are used throughout this manual.

1 • Prepare samples...

The bullet point is used to indicate an action to be performed.

This icon is used to indicate specific information concerning the VIDAS instrument called "VIDAS blue" in the manual. Unless otherwise specified, the information in the manual applies to the VIDAS, whichever model is used.

2

Warnings The following warnings are used throughout the manual:

3

−

for safety reasons (DANGER!),

−

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

−

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

4

5

VIDAS® Instrument User's manual

1-3

How to use this manual Graphic symbols

Graphic symbols V.A 09/2003 – màj smn –10/2004

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

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) TERMINAL

PROTECTIVE CONDUCTOR TERMINAL

Frame or chassis TERMINAL

Equipotentiality

ON (power supply)

OFF (power supply)

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

1-4

VIDAS® Instrument User's manual

How to use this manual Graphic symbols

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

Equipment protected throughout by DOUBLE INSULATION or REINFORCED INSULATION (equivalent to Class II of IEC 536)

1

Risk of electric shock

Caution: see accompanying documents

2 High temperature

Potential pinch point

3

Potential biohazard

i LOT

or REF

Consult Instructions for Use

Batch code

4

Catalogue number

Temperature limitation

5 EC

REP

Authorised representative of the European Community

Keep dry

VIDAS® Instrument User's manual

1-5

How to use this manual Graphic symbols

Manufacturer

Date of manufacture

IVD

SN or SN

In Vitro Diagnostic Medical Device

Serial number

Keep away from magnetic field

Separate collection for waste electrical and electronic equipment

1-6

VIDAS® Instrument User's manual

2

Functional description

Introduction This chapter describes the VIDAS instrument: −

its configuration components,

−

general features and technical specifications,

−

operating principles,

−

performance checks / self-tests.

VIDAS® Instrument User's manual

2-1

Functional description Graphic symbols

Analytical module (example)

Computer module (example)

Reagent strip

SPR®

Fig. 2-1: VIDAS configuration

2-2

VIDAS® Instrument User's manual

Functional description Description / aim

Description / aim VIDAS is a compact automated multiparametric immunoanalyzer including: −

the VIDAS analytical module divided into five independent sections each containing six assays with compatible protocols,

−

the VIDAS PC software allowing up to two VIDAS modules to be operated,

−

the reagents presented in kits of 60, 30 or 10 unit tests including : − the SPR®s and reagent strips, −

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

−

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

−

the package insert.

1

2

The basic VIDAS workflow steps consist of:

• creating predefined sections, • performing calibrations and controls, • running assays. VIDAS offers routine batch or random access (mixed) testing for: − − − − −

3

serology, immunochemistry, antigen detection, industrial microbiology, immunohemostasis.

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

4

reliable results, ease-of-use, rapid analyis results.

® Vitek Immuno Diagnostic Assay System.

The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay).

5

The enzyme used in the VIDAS range is alkaline phosphatase. The substrate is 4-methyl umbelliferyl phosphate (4-MUP) hydrolyzed into 4-methyl umbelliferone. Umbelliferone fluoresces at 450 nm after excitation at 370 nm.

VIDAS® Instrument User's manual

2-3