Biomerieux mini Vidas User manual

mini VIDAS®

Procedures Manual

4501 - 1721 en

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

Tel. [phone] - Fax [phone] http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon © 1996-2008. bioMérieux, S.A.

REF 99188

version F 07/2008

4501-1584 E en

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Distribution in over 130 countries

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Revisions

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

	Version	Date of	Modifications	Page (s) modified
		printing
	A	03/1996	Creation	All
	B	03/2003	New format (7x9) - Manual update	All
	C	04/2005	Modification relating to the new mini VIDAS®	All
			model
	D		Not used
	E	10/2005	New software version	All
	F	07/2008	New software version	All

mini VIDAS® Procedures Manual

Revisions-1

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.

L i a b i l i t y d i s c l a i m e r

THIS MANUAL IS PROVIDED "AS IS" WITHOUT ANY WARRANTY, EITHER EXPRESS OR IMPLIED, OF MERCHANTABILITY, SAFETY, QUALITY, ACCURACY OR THE PERFORMANCE OF PRODUCTS DESCRIBED IN THIS MANUAL. IN ADDITION, THERE SHALL BE NO IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NOR NON INFRINGEMENT OF THIRD PARTIES' INTELLECTUAL PROPERTY RIGHTS.

In no event shall bioMérieux S.A. be liable for any direct, consequential, incidental or indirect damage or consequence related to, arising out of or in connection with, any use of this manual and/or its results by the User and/or any third party.

In no event shall this manual be construed as an undertaking of bioMérieux S.A. bioMérieux S.A. reserves the right to modify this manual without notice and shall incur no liability as a result of such modification.

This manual is provided for information purposes only.

I n t e l l e c t u a l P r o p e r t y

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 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 any other right to use this manual including without limitation, the right to reproduce, represent, adapt or translate all or part of this manual by any means whatsoever without the prior written consent of bioMérieux S.A.

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

IMPORTANT! USE OF THIS MANUAL CONSTITUTES ACCEPTANCE OF THE TERMS AND CONDITIONS SET FORTH HEREIN.

bioMérieux, the blue logo 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.

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 purposesdisplay the Software on any computer other than the Computer, reproduce, sell, rent, lease, modify, adapt, translate or otherwise dispose of, all or part of the Software, the equipment, the user manual and its related documentation.

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

II – Intellectual Property

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

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

III – Warranties

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

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

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

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

IV – Liability

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

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

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

V – Applicable Law and settlement of disputes

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

Parties shall make their best efforts to settle any dispute through amicable discussions. In the event no amicable settlement is reached in the period of three (3) months after communication of the claim, any litigation shall be held in the exclusive jurisdiction of the courts of Lyon, France.

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

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

Signature and User's stamp:

COPY TO BE RETURNED TO BIOMERIEUX S.A.

4501-1577 A en

	SOFTWARE LICENSE AGREEMENT
User:	No.:
Software:	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 purposesdisplay the Software on any computer other than the Computer, reproduce, sell, rent, lease, modify, adapt, translate or otherwise dispose of, all or part of the Software, the equipment, the user manual and its related documentation.

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

II – Intellectual Property

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

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

III – Warranties

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

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

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

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

IV – Liability

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

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

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

V – Applicable Law and settlement of disputes

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

Parties shall make their best efforts to settle any dispute trough amicable discussions. In the event no amicable settlement is reached in the period of three (3) months after communication of the claim, any litigation shall be held in the exclusive jurisdiction of the courts of Lyon, France.

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

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

Signature and User's stamp:

COPY TO BE KEPT BY USER

General Warnings

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

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.

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.

Table of contents

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

Table of contents

3	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 user ID..............................................................................................................................	3-14
	Setting the report header..............................................................................................................	3-16
	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

	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

Table of contents

6	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

	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

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

	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

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
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
mini VIDAS® Procedures Manual		VI-1

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

1 How to use this manual

I n t r o d u c t i o n

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

How to use this manual

Finding topics or procedures

F i n d i n g t o p i c s o r p r o c e d u r e s

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	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.
List of figures	Pages VI-1 to VI-2 contains a list of the figures in the manual.
Warnings	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!).
Chapter contents	Every chapter containing procedures begins with a mini table of contents
	specifically for the chapter.
Graphic symbols	The standard symbols used for bioMérieux® instruments can be found on page
	1-6.
Page Headers	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.

1-2	mini VIDAS® Procedures Manual

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.

1

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

How to use this manual

Typographic conventions

T y p o g r a p h i c c o n v e n t i o n s

• Press

INSTALL

Following are the terms and visual cues used in this manual to aid in your understanding of the procedures.

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).

Reading	This typography is used to represent selection keys, e.g
	• Select [Utility Menu].

T h e m i n i V I D A S k e y p a d

	There are 24 keys on the mini VIDAS keypad. They are divided among four
	groups, according to their function:
Number 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>.
Function keys	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	Four keys used to move the cursor on the screen.
	The arrow keys are referenced by their direction, enclosed in angle brackets
	"< >" : <↑>, <↓>, <←> and <→>.

1-4	mini VIDAS® Procedures Manual

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.

1

mini VIDAS® Procedures Manual

1-5

How to use this manual

Graphic symbols

G r a p h i c s y m b o l s

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