MU_161150_637_A_mini VIDAS.book

MU_161150_637_A_mini VIDAS.book
161150-637- A - en - 2016/03 – 161150-637
User Manual
bioMérieux SA
376 Chemin de l’Orme
69280 Marcy-l’Etoile - France
Tél: 33 (0)4 78 87 20 00
Fax: 33 (0)4 78 87 20 90
www.biomerieux.com
General Information
The content of this manual is based on the Software release 5.6.
Please discard any previous copies of this manual if relevant.
This manual may contain information or references relating to certain bioMérieux products,
software or services which are not available in the country of release; this shall not mean that
bioMérieux intends to market such products, software or services in such country.
To request copies of publications or for any technical request / assistance, contact bioMérieux
or your local distributor (contact information available on www.biomerieux.com).
Note: The screens and figures shown are intended as illustrations only and must not be interpreted
as actual representations of data, results or equipment. 
Screens and equipment are not shown to scale.
IMPORTANT: Please read this manual carefully before using the mini VIDAS® analyzer.
Intellectual Property
BIOMERIEUX, the blue logo, SPR and VIDAS are used, pending and/or registered
trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.
Any other name or trademark is the property of its respective owner.
© 2016 bioMérieux SA
bioMérieux SA RCS Lyon 673 620 399.
Table of Contents
Introduction to the System ........................................................................................ 1-1
Intended Use and Users of the mini VIDAS® analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Benefits and Limitations of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Warning and Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Statement Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
General Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Standard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Safety Information ...................................................................................................... 2-1
System Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
SPR® Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Reagent Strip Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Strip Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Safety Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Precautions For Use Of Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Preparing the Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Precautions for Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
At the End of the Run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
System Description and Basic Operations .............................................................. 3-1
mini VIDAS® analyzer Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Screen and Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Internal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Rear Panel Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Bar Code Readers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Memory Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Technical Data and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Physical Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Technical features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Temperature control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Optional Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
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Accessories for Industry Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Assay Kit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
VIDAS®Assay Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
System Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Analysis Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Principle of a VIDAS® Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Analysis Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Principles Of Calibration / Recalibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Overview of Operation Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Strip and SPR® Sections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Microprocessor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Incubator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Detection System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Central Processing Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Software Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Selecting a Menu Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30
The Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Online Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Viewing Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33
Screen Paging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34
System Installation and Configuration ..................................................................... 4-1
Unpacking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Choosing A Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Electrical connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Checking Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Connecting an external bar code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Starting the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Shutting Down the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Configuring the mini VIDAS® analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Selecting a Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Setting Dose Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Setting User IDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Setting the Report Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Setting the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Setting Display Contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
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Selecting the Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Setting the Date/time Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Defining the Sample ID Character Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Changing the Keyclick Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Changing the Beep Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Error Beeps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Setting the Final Error Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Enabling Display Blinking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Miscellaneous Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
LIS User Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Creating Normal Ranges for Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Installing Paper in the Internal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Print Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Workflow and Instructional Procedures ................................................................... 5-1
Routine Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Planning a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Managing the Job List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Defining the Type of Run Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Checking Assay Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Defining the Standards/calibrators and Controls to be used . . . . . . . . . . . . . . . . . . . . . 5-3
Running Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Entering Master Lot Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Running Assays in «Load and Go» Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Loading Reagent Strips and SPRs® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Running Assays in «Defined» mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Running Internal Quality Controls (for Clinic Use Only) . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Viewing Stored Standards/calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Viewing Master Lot Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Stopping a Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Results and Reports ................................................................................................... 6-1
The Assay Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Report Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Qualitative Assays Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Quantitative Assays Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Assay Report Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Reprinting an Assay Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Reprinting an Assay Report without Editing Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Editing Data before Reprinting an Assay Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Validating LIS Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Canceling Uploads of Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
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Deleting the Remaining Non-validated LIS Upload Data . . . . . . . . . . . . . . . . . . . . . . . 6-10
Stopping Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Validating Internal Quality Controls Transfers (for Clinic Use Only). . . . . . . . . . . . . . . . . . 6-11
Printing the mini VIDAS® Assay List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Miscellaneous Operations ......................................................................................... 7-1
Taking a Section Off line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Changing Factory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Testing the mini VIDAS® analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Testing the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Testing the Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Testing the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Testing the audio output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Updating an Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Preliminary Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Reading Assay Update Card Bar codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Displaying the mini VIDAS Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Printing the mini VIDAS Software Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Displaying the Assay Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
Section Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Printing the Assay Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11
Updating the mini VIDAS® Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Verifying the Memory Card Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Parking the mini VIDAS® analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Maintenance ................................................................................................................ 8-1
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Required Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Cleaning and Disinfection Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Cleaning Optical Lenses (Monthly) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Checking the Pipetting System (Monthly) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Calibration and Adjustments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Optical System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Pipetting System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Temperature Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Master Curve Establishment and Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-16
Appendix - Maintenance Records .............................................................................A-1
Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Maintenance Check-List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2
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Appendix - Troubleshooting ......................................................................................B-1
Indication Of Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
Displaying Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
Error Messages and Recovery Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
Start Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-2
Manually Entering Bar codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5
Other Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7
Instrument Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-7
Problems that May Occur with the Bar code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-15
The reader does not emit a beam of light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-15
Reader fails to read bar codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-15
Assay Report Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-16
Correcting Assay Report Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-16
Assay Report Error Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-16
Error Messages on Assay Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-17
Printer Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-17
Viewing Saved Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-18
Displaying and Printing Instrument Temperatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-18
Appendix - Installing external hardware...................................................................C-1
External printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Before Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Possible Error Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Installing the Bar code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Equipment Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Appendix - Computer interface information.............................................................D-1
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
Configuration Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-2
Example of a mini VIDAS® Upload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
Appendix - Technical Data and Specifications (previous versions of mini VIDAS®
analyzers) ....................................................................................................................E-1
Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Physical Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-1
Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-2
Environmental Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
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Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
Sound Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-3
Technical features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Motors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Pumping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Temperature control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Absolute Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Relative Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Thermal resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-4
Optics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Assay Kit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
VIDAS® SPR® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
VIDAS® Single Reagent Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Appendix - Glossary ................................................................................................... F-1
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1
Introduction to the System
Intended Use and Users of the mini VIDAS® analyzer
The mini VIDAS® system is an immunodiagnostic system intended to be used by trained and
qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and
industrial applications.
The mini VIDAS® system is intended to execute an immunoassay protocol and to release
results according to the package insert of the VIDAS® assay kits.
Benefits and Limitations of Use
The mini VIDAS® analyzer 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.
The mini VIDAS® analyzer is a completely self-contained system that includes:
•
an analytical module (12 test positions i.e. two 6-test sections) and,
•
data processing equipment (monitor, keypad, printer).
The mini VIDAS® analyzer enables different analytes to be used simultaneously according to
their compatibility.
The number of tests/ hour depends on the kit (eg: up to 36 tests/ hour with VIDAS® PCT).
It is used with VIDAS® assay kits covering numerous immunoassay* fields (non exhaustive
list):
•
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. Please contact your local bioMérieux representative for further information.
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mini VIDAS®
Warning and Safety Messages
Introduction to the System
Warning and Safety Messages
The user documentation uses several types of statements to alert you to important
information. Important information is labeled in text and identified using symbols.
Statement Types
The statement types are Warning, Caution, Important, and Note. The following examples
define each statement type. The general caution symbol is used in these examples, but other
symbols (see Standard Symbols on page 1-6) may be used instead.
The warning messages in this manual mainly refer to:
WARNING
A Warning statement alerts the user to the possibility of injury, death, or
other serious adverse reactions associated with the use or misuse of the
device.
CAUTION: A Caution statement alerts the user to the possibility of a problem with
the device associated with its use or misuse. Such problems include device
malfunction, device failure, damage to the device, or damage to other property.
Where applicable, a Caution statement may include a precaution that should be
taken to avoid the hazard.
IMPORTANT: An Important statement relates to content presented in the user documentation. It is
used to reinforce the user’s understanding of selected information.
Note: A Note statement supplies additional information about a topic.
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mini VIDAS®
General Statements
Introduction to the System
General Statements
This section provides important statements that apply to all products. Equipment meets the
requirements and standards stated in the certificate supplied with it.
WARNING
Equipment is intended for professional use only.
Laboratory personnel should be qualified and adhere to the principles of
good laboratory practice.
All the user documents supplied must be read prior to use of the equipment.
Under no circumstance should the user dismantle equipment due to the risk
of touching dangerous parts, including parts that are infectious or
connected to a source of electric power.
Do not obstruct the equipment and hardware ventilation apertures, and
leave sufficient clearance around the equipment for the circulation of air.
All biological and industry samples should be considered as potentially
infectious. Suitable individual protective equipment is required when
handling chemical or biological substances.
bioMérieux is in no case liable for the harmful consequences of incorrect
use or improper handling of these substances.
WARNING
Electromagnetic Compatibility (EMC):
The EMC class of the equipment is indicated on the certificate supplied with
it.
If equipment is a class A product, it may cause radio interference in a
domestic environment, in which case the user will be required to correct the
interference at his own expense.
Do not use this device near strong sources of electromagnetic radiation (for
example, intentionally unprotected radio-electric sources), which could
interfere with the operation of the equipment.
It is recommended to evaluate the electromagnetic environment before
starting the device.
WARNING
Only modify the software configuration parameters you are authorized to
modify and which are described in the user documentation.
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mini VIDAS®
General Statements
Introduction to the System
WARNING
Decontamination of equipment at the end of its life cycle:
The following instructions must be followed by all users in countries where
local legislation imposes the treatment and recycling of equipment at the
end of its life cycle.
As a general rule, and as a precautionary measure, any part of the
equipment (including sub-assemblies, components and materials)
considered to be potentially infectious, must be decontaminated, whenever
possible, or removed if decontamination is impossible or presents a risk.
Any part considered to be potentially infectious, which is not
decontaminated, must be removed from the instrument before following the
normal channels for elimination of infectious products, in accordance with
local regulations.
The decontamination instructions in the user documentation correspond to
the parts of the equipment that are potentially infectious according to their
intended use. These operations must be performed before the equipment is
transferred to a third party.
However, bioMérieux cannot exclude that other parts of the equipment have
not been contaminated in other circumstances, in particular as the result of
spillage of infectious substances. In this case, the user is solely responsible
for decontaminating these parts or removing them before they follow the
normal channels for elimination of infectious products.
WARNING
This statement only applies to European countries with regard to the waste
electrical and electronic 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 its appropriate disposal.
IMPORTANT: Electrical or other connections should only be made using the accessories supplied
with the equipment.
IMPORTANT: It is important to follow all the restrictions on use, particularly concerning temperature,
storage, installation and voltage, which are indicated on the product label or in the user
documentation.
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mini VIDAS®
General Statements
Introduction to the System
IMPORTANT: The accuracy of results obtained with this equipment depends on the maintenance
operations described in the user documentation (user maintenance and/or periodic
preventive maintenance performed by bioMérieux).
IMPORTANT: The user should be aware that if the maintenance operations are not performed, are
only partially performed, or are not performed as described in the user documentation,
bioMérieux is in no case liable for any false test results obtained.
IMPORTANT: It is recommended to keep the original packaging materials in case the equipment
needs to be moved. Any damage directly or indirectly resulting from the transport of
the equipment without adequate containers will not be covered by the warranty.
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mini VIDAS®
Standard Symbols
Introduction to the System
Standard Symbols
The following symbols may appear in the instructions for use or on the instrument, package
inserts, or packaging. Some of the following symbols may not be used on the instrument,
package insert nor packaging. When surrounded by a triangle on a yellow background, the
symbol highlights an immediate warning and is positioned on the instrument itself.
CE-Marking of Conformity
Compliance with US and Canadian Safety
Standards certified by CSA
In Vitro Diagnostic Medical Device
Batch code
Authorized Representative in the European
Community
Catalog number
Serial number
Consult Instructions for Use
Use by date
Manufacturer
Date of manufacture
This way up
Do not stack
Caution, consult accompanying documents
Contains sufficient for <n> tests
Do not reuse
Keep dry
Keep away from sunlight
Fragile, handle with care
Protect from light
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mini VIDAS®
Standard Symbols
Introduction to the System
Humidity limitation
Keep away from magnetic field
Temperature limitations
Upper limit of temperature
Lower limit of temperature
Sterile
Positive control
Negative control
Biological risk
Electric shock warning
Radiation warning
Potential pinch-point warning
Laser beam
Shearing hazard
High temperature
Hazardous magnetic field
Potential tip-over/crush hazard
Acute toxicity
Corrosives
Sodium azide
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mini VIDAS®
Standard Symbols
Introduction to the System
Irritant
Recyclable
Separate collection for waste electrical and
electronic equipment
Environmentally friendly use period. Actual
number of years may vary by product. This
symbol is typically orange in color.
Fuse
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 (supply)
OFF (supply)
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)
Ethernet port
161150-637 - A
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mini VIDAS®
2
Safety Information
It is essential that the warnings, cautions and safety requirements contained in this manual are
read and understood by the user before operating the system.
Warning symbols have been placed on the system to draw your attention to areas of potential
hazards.
System Compliance
The mini VIDAS® analyzer conforms to the relevant European regulations for electrical safety
and electromagnetic compatibility (EMC).
•
This IVD instrument complies with the emissions and immunity requirements of IEC
61326.
•
This is a Class A product. The instrument was designed and tested against CISPR 11,
class A.
CAUTION: Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets, etc.) may cause damaging static
discharges that may cause erroneous results.
•
Laser Class 1
The Instrument is a Class 1 LED/Laser product in accordance with the requirements of:
•
21CFR1040.10 and 1040.11 except for deviations pursuant to Laser Notice No 50, dated
July 26,2001
•
IEC 60825-1: 1993+Amendments
•
EN 60825-1:1994+Amendments
•
IEC 60825-1: 2007
•
EN 60825-1:2007
Class 1 devices are not considered to be hazardous when used for their intended purpose.
CAUTION: Use of controls, adjustments or performance of procedure other than
those specified in the user’s manual may result in hazardous LED/laser light
exposure.
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mini VIDAS®
Instrument Labels
Safety Information
Instrument Labels
The following photos of the analyzer illustrate the positions of the safety warning labels.
SPR® Block
The label is applied above the SPR® slots inside each SPR® block.
This label reads:
WARNING - DO NOT APPLY PRESSURE IN ORDER TO SEAT SPRS.
INADVERTENT EJECTION OF SPR MAY RESULT.
Figure 2-1: SPR® Block Label
Figure 2-2: Position of the label
161150-637 - A
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mini VIDAS®
Instrument Labels
Safety Information
Reagent Strip Tray
When you pull out the reagent strip tray, the biological risk label appears.
Figure 2-3: Reagent strip tray label (Biohazard)
Figure 2-4: Position of label
161150-637 - A
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mini VIDAS®
Instrument Labels
Safety Information
Strip Section
The label is applied inside the transparent part of the each section door. In addition to the
biological risk, the label directs the user to read the user manual in French and English.
This label reads:
CAUTION: BIOHAZARD MATERIAL. SEE MANUAL
FOR DECONTAMINATING INSTRUMENT
Figure 2-5: Strip section label
Figure 2-6: Position of label
161150-637 - A
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mini VIDAS®
Instrument Labels
Safety Information
Rear Panel
The label is positioned on the rear panel of the mini VIDAS® analyzer.
This label reads:
WARNING - FOR CONTINUED PROTECTION
AGAINST RISK OF FIRE, REPLACE ONLY WITH
FUSE OF THE SPECIFIED TYPE AND CURRENT
RATING.
FUSE 5x20 4AT 250V (TIME LAG TYPE)
DISCONNECT POWER BEFORE CHANGING THE
FUSE.
Figure 2-7: Label (rating plate)
161150-637 - A
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mini VIDAS®
Safety Precautions
Safety Information
Safety Precautions
Pay particular attention to the following safety precautions. If these safety precautions are
ignored, injury or damage to the instrument may occur. Each individual precaution is
important.
WARNING
If the equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
WARNING
All biological and industry samples and quality control (QC) products
incubated in this system, as well as all waste in the waste containers,
should be treated as potentially biohazardous materials. All materials and
mechanical components associated with the waste systems should be
handled according to safe microbiological practices in compliance with the
installation site's biohazard procedures. Use the personal protective
equipment recommended by the facility when handling any of these
components, including gloves, safety glasses, and a lab coat.
The system must be decontaminated before its covers are removed by
service personnel. Ensure that appropriate decontamination is carried out if
hazardous materials are spilled on or into the equipment or surrounding
areas.
WARNING
Treat waste material, including consumable items, and any components
coming into contact with waste material as having the potential hazards of
the samples used.
All service personnel should be familiar with the Material Safety Data Sheet
(MSDS) for all materials used in the procedures relating to this instrument,
and the correct procedures for handling these materials.
WARNING
Even when power is removed from the instrument, the potential exists for
electricity to be generated if components, such as assemblies that are
mounted on belts, are moved too quickly. Components should be moved
slowly to prevent the buildup of electricity. Failure to comply may result in
injury to personnel or damage to the instrument.
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mini VIDAS®
Safety Precautions
Safety Information
WARNING
Do not replace detachable main supply cords by inadequately rated cords.
Only use main supply cords provided by the manufacturer.
Do not replace electric cables. If cables do not have the same technical
specificities, there is a risk of electrical shock.
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.
WARNING
Electronic equipment can be the source of electrical shocks. Installation,
service, and repair should only be performed by authorized and qualified
bioMérieux personnel.
WARNING
All power switches should be off when connecting or disconnecting cables
to power outlets to reduce the risk of electrical shock.
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2-7
mini VIDAS®
Safety Precautions
Safety Information
WARNING
bioMérieux recommends connecting this instrument to a main power outlet
that is protected with a ground fault circuit interrupter to reduce the risk of
electrical shock.
The electrical supply to which the system is connected must conform to
current standards:
•
diameter of cables,
•
grounding,
•
connector calibration and type etc.
The electrical power supply must be direct, individual, calibrated, and
compatible with the technical specifications of the product or
configuration.
WARNING
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® analyzer to the same power supply as
devices which generate high current surges (centrifuges) or which, due to
frequent start-ups, generate interferences if they are ill-protected (freezers,
water baths etc.).
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2-8
mini VIDAS®
Safety Precautions
Safety Information
WARNING
As with any mechanical system, certain precautions must be taken when
operating the instrument. The instrument has a protective cover intended to
prevent the operator from coming into contact with any moving parts and
aerosols. When servicing the instrument, take special care, as there are
moving parts that can cause injury.
WARNING
Cleaning and disinfecting solutions have corrosive properties. Always wear
protective (chemical resistant) gloves and safety glasses when handling
cleaning and disinfecting solutions.
WARNING
Hot surfaces can cause injury.
WARNING
After replacement or recalibration of the scanner head of the mini VIDAS®
analyzer, reperform a calibration for each assay used.
CAUTION: Any liquid spilled on the system may result in system malfunctioning.
If liquid is spilled on the system, wipe it up immediately using decontamination
wipes.
CAUTION: The mini VIDAS® analyzer has been carefully configured for optimal
system performance. Altering the configuration may severely hamper the usability
of the instrument.
IMPORTANT: For optimum operation of the instrument, the SPR® block and tray doors must be kept
closed.
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2-9
mini VIDAS®
Safety Precautions
Safety Information
Note: Before performing electrical safety or other compliance testing on the instrument, contact your
local bioMérieux representative.
WARNING
The user must only perform the maintenance operations described in this
user manual and rigorously follow each of the steps.
The use of tools not specified by bioMérieux is forbidden.
Powderless gloves, a lab coat and safety glasses or goggles must be worn
when performing maintenance operations.
Always use personal protective equipment, including powderless gloves, a
lab coat and safety glasses or goggles when handling reagents.
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2-10
mini VIDAS®
Precautions For Use Of Reagents
Safety Information
Precautions For Use Of Reagents
General Precautions
CAUTION: Carefully read the reagent kit package insert before using the
reagents.
Store the reagent kits according to the kit label instructions.
ONLY use bioMérieux reagents to perform the analyses. The use of any other
reagents is the sole responsibility of the user.
Do not mix reagents from different lots.
Do not use reagents after the expiration date.
Use powderless gloves.
Preparing the Analyses
CAUTION: Sample preparation steps, which may vary from assay to assay, are
covered in the package insert for each assay.
ONLY remove the required number of tests from the reagent kit.
Reagents should be at room temperature before use (refer to the package insert in
the reagent kits).
Carefully reseal the SPR® pouch after use with the desiccant inside.
Carefully mix the standard/calibrator, controls and samples before pipetting into
the strip.
Do not use visibly deteriorated strips (damaged foil or plastic) or if reagents are
leaking, as this could affect the accuracy of test results.
Do not re-use a SPR®.
Avoid touching the SPR® dots.
Check that each SPR® has a color-coded dot that is clean and undamaged.
Check that each SPR® dot on top has a hole.
Reject SPRs® with no hole in the center of the dot.
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mini VIDAS®
Precautions For Use Of Reagents
Safety Information
Precautions for Samples
CAUTION: The sample must not contain any solid matter that could clog the tip of
the SPR®.
Always put the correct sample into the assigned strip.
At the End of the Run
CAUTION: If a SPR® does not have its color-coded dot:
161150-637 - A
•
Reject the result corresponding to the defective SPR®.
•
Check that the dot is not adhered to the SPR® block or the SPR® seal and
if it has, remove it.
•
Repeat the assay for the defective SPR®.
•
Contact bioMérieux Technical Assistance or your local bioMérieux
representative.
2-12
mini VIDAS®
3
System Description and Basic Operations
mini VIDAS® analyzer Description
6
1
5
2
3
4
7
Figure 3-1: mini VIDAS® analyzer
1
2
3
4
5
6
7
—
—
—
—
—
—
—
Operating status light
SPR® block
Strips section
Strip preparation tray
Keypad and screen
Thermal printer
External bar code reader
Note: Previous versions of the mini VIDAS® analyzer may not have a strip preparation tray.
CAUTION: Never use material other than that specified by bioMérieux.
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3-1
mini VIDAS®
mini VIDAS® analyzer Description
System Description and Basic Operations
Screen and Keypad
2
1
5
3
4
Figure 3-2: mini VIDAS® screen and keypad
1 — Liquid crystal display screen
2 — Selection keys
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 used to select them.
3 — Arrow keys
Used to move the cursor on certain screens.
The up and down keys are also used to page the display screen.
4 — Number keys
Used to input numbers and to make input selections.
5 — Function keys
Function key
Description
Undoes a keypad input.
Deletes the last action and returns to the previous operation.
Returns the user to the previous screen during a procedure or returns to a
particular menu or corrects a selection error.
Help key:
• Press it once to display information about a screen, error, or flashing screen.
• Press it twice to access the Help Mode Screen.
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3-2
mini VIDAS®
mini VIDAS® analyzer Description
System Description and Basic Operations
Internal Printer
The mini VIDAS® analyzer includes an internally mounted thermal printer.
The printer is located on the top of the instrument, directly above the keypad and screen.
Rear Panel Components
1
2
3
4
5
Figure 3-3: mini VIDAS® rear panel
1 — Memory card slot
This slot is for the mini VIDAS® software update cards.
2 — Diagnostic port
Used by bioMérieux Field Service Engineers to troubleshoot the mini VIDAS® analyzer.
Also used external bar code reader.
3 — Computer port
Used to connect the mini VIDAS® analyzer to a computer.
Assay results are then sent to that computer via this connection.
4 — Printer port
Used to connect the mini VIDAS® analyzer to a matrix parallel printer.
5 — Power inlet module with ON/OFF switch, mains connector and replaceable fuses.
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3-3
mini VIDAS®
mini VIDAS® analyzer Description
System Description and Basic Operations
Bar Code Readers
There are two types of bar code readers:
1. 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.
• enter the sample ID and read the master lot data.
2. A bar code reader inside the instrument identifies the reagent strips.
Memory Cards
Memory cards store the mini VIDAS® software.
Figure 3-4: mini VIDAS® memory card
bioMérieuxsends a program update memory card for software updates.
This card should be returned to bioMérieux after your instrument has been upgraded.
CAUTION: When using memory cards:
161150-637 - A
•
Keep them away from humidity, extreme temperatures, direct sunlight,
and strong magnetic fields.
•
Do not bend them.
•
Handle them with care.
3-4
mini VIDAS®
Technical Data and Specifications
System Description and Basic Operations
Technical Data and Specifications
Technical data and specifications are given for the latest version of the mini VIDAS® analyzer
(analyzer with transparent blue section covers).
For previous versions of the mini VIDAS® analyzer, see Appendix E, Appendix - Technical
Data and Specifications (previous versions of mini VIDAS® analyzers).
Dimensions
Instrument + Packaging
Instrument
Height (cm)
59
45
Width (cm)
80
57.5
Depth (cm)
66
55
Instrument + Packaging
Instrument
47
40
Weight
Weight (kg)
Physical Space Requirements
Value
Height (cm)
65
Width (cm)
120
Depth (cm)
90
The instrument must be placed on a flat surface tilted no more than 5°.
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3-5
mini VIDAS®
Technical Data and Specifications
System Description and Basic Operations
Electrical Specifications
The instrument includes an internal bar code reader with a 660 nm LED whose radiation is
Class 1 according to IEC 60825-1.
Specification
Value
Voltage
100 - 240 VAC
3 - 1.2 A
Consumption
100 - 240 VAC
1.5 – 0.8 A
Frequency
50 - 60 Hz
Power
150
Fuse Current
External: 4.0 AT
Approximate Emission of Heat
512 Btu / hr
Power Switch
Location: back of instrument
Type: bipolar (phase + neutral)
Max. leakage of current: < 1mA
150 W
Caution: 

The user must comply with the technical specifications and standards in this
manual to ensure user safety as well as the proper functioning of the instrument.
bioMérieux is in no case liable for any damage that may arise from failure to
comply with these specifications or any operation conducted on the equipment not
in compliance with these mandatory standards.
Moreover, the warranty for this equipment is expressly subject to use of the mini
VIDAS® analyzer in compliance with the procedures and specifications herein.
Environmental Conditions
Specification
Value
Type of Installation
For indoor use only
Installation category
II
Pollution degree
2
The mini VIDAS® analyzer is compliant with the environmental safety requirements in IEC
61010-1, section 1.4.
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3-6
mini VIDAS®
Technical Data and Specifications
System Description and Basic Operations
Temperature
Specification
Value
Operating temperature
15°C to 30°C (room temperature)
Storage temperature
-10°C to 50°C
Note: The average heat emission is approximately 512 BTU - 150 W.
Humidity
Specification
Value
Relative humidity
10% to 80% RH non-condensing
Humidity during storage and transport
(non-condensing within the storage and
transport temperature range)
up to 90%
Altitude
Specification
Value
Maximum altitude
2,500 m
Specification
Value
During an analysis
< 59 dBA
Sound Level
Technical features
Capacity
•
12 test positions (2 sections with 6 positions in each section).
•
Up to 30 tests/hour depending on the type of assay used (see test duration in the package
insert for each VIDAS® assay).
•
Automatic control by stepper motors.
•
2 pumps; one for each section
•
Mixing, diluting, and transferring of liquids
Motors
Pumping
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3-7
mini VIDAS®
Technical Data and Specifications
System Description and Basic Operations
Temperature control
Absolute Accuracy
•
SPR®: 36°C – 38°C
•
Tray: 35°C – 38°C
Relative Accuracy
•
SPR®: ± 0.7°C between the 2 sections
•
Tray: ±
1°C between the 2 sections
Thermal resistance
•
Process: thermal resistance
•
Automatic Control: by thermal probe
Optics
161150-637 - A
Specification
Value
Detector
Photodiode fluorimeter
Detection range
40 to 40 000 nmol of 4MU (4-Methyl Umbelliferone)
Automatic checking
Automatically checks the optic system every 12
hours against a reference standard (named "solid
standard"); automatic calibration if the difference
with the solid standard is > 0.6 %
3-8
mini VIDAS®
Optional Hardware
System Description and Basic Operations
Optional Hardware
•
External printer (optional)
Note: See Appendix - Installing external hardware.
•
Unidirectional interface (optional)
Note: See Appendix - Computer interface information
Accessories for Industry Use
•
VIDAS® Heat and Go or water bath (95-100°C)
These accessories are necessary for the sample preparation procedures recommended in the
package insert.
Figure 3-5: VIDAS® Heat and Go instrument
Contact bioMérieux or your local bioMérieux representative to purchase the VIDAS® Heat and
Go instrument.
Refer to the VIDAS® Heat and Go user's manual for further instructions.
161150-637 - A
3-9
mini VIDAS®
Assay Kit Specifications
System Description and Basic Operations
Assay Kit Specifications
VIDAS® SPR®
Specification
Value
Length
76 mm
Material
Plastic polymer
Work volume
5 to 350 µl
VIDAS® Single Reagent Strip
External dimensions
Value
Length
157 mm
Width
18 mm
Depth
15 mm
Well
Capacity
Sample Well
960 µl
Reagent Well
960 µl
Substrate Well
530 µl
The strip is sealed by a foil to ensure that no evaporation will occur that may compromise the
reagents.
The substrate well is made of a plastic that complies with the appropriate optical qualities.
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3-10
mini VIDAS®
Reagents
System Description and Basic Operations
Reagents
VIDAS®Assay Kit
Each VIDAS®assay kit contains everything required to carry out a specific assay:
•
Single or dual reagent strips,
•
SPRs® (Solid Phase Receptacle)
•
Standard/calibrator(s)
•
Controls
•
Diluent (depending on the kit),
•
a Master Lot Entry (MLE) bar code printed on the box label
Note: Some assay kits may also include a Master Lot Entry (MLE) card.
•
a package insert (included in the kit or downloadable from a server) with the protocol to be
loaded if necessary
•
A closing clip for the bag of SPRs® (in certain kits)
Single Reagent Strip
The VIDAS® single reagent strip is made of polypropylene and contains ten wells.
2
1
3
4
Figure 3-6: Single reagent strip
1
2
3
4
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—
—
—
—
First well, where the sample is placed
Eight reagent wells (conjugate, diluent, wash buffer)
the last well is the optical cuvette in which the fluorescence of the substrate is measured.
Tab ensures that the strip is correctly positioned in its channel guides.
3-11
mini VIDAS®
Reagents
System Description and Basic Operations
Single Reagent Strip for Immuno-Concentration (for Industry Use Only)
These strips are used to concentrate a targeted antigen. No result interpretation is done.
1
2
Figure 3-7: Single reagent strip for immuno-concentration
1 — Well where the immunoconcentrated targeted antigen is released at the end of the run
2 — Well where sample is dispensed
Dual Reagent Strip (for Clinic Use Only)
Some assays require the use of a dual reagent strip, consisting of two strips side by side.
The dual reagent strip is used to compensate for sample variability.
The sample is divided between the two sample wells on the two reagent strips.
One strip serves as the reference strip and the other as the sample test strip.
The sample test strip contains a reagent which is not included in the sample reference strip.
A comparison of the measurements from the two strips determines the test result.
Dual strips fit in the reagent strip tray exactly like single strips, but they require two channels.
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mini VIDAS®
Reagents
System Description and Basic Operations
Reagent Strip Label
Each 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 code
• the manufacturing lot number
• the sequence number
• the assay kit expiration date
The figure below represents a typical label:
1 2
3
7
4
5
6
Figure 3-8: Reagent strip label
1 — Alphanumeric bar code.
The first two characters of the alphanumeric code indicate the unique assay code (UAC).
If the system is unable to read this code, the alphanumeric form of the bar code is used
to enter the bar code.
2 — Assay code
The assay code is based on three or four characters 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.
3 — Lot number
4 —
5 —
6 —
7 —
161150-637 - A
The lot number is used by the mini VIDAS® analyzer to code the expiration date of the
reagent lot.
Expiration date
This corresponds to the expiration date of the reagent lot.
When the bar code reader reads this date, the mini VIDAS® analyzer compares it to the
date stored in its memory to ensure that the lot has not passed its expiration date.
Sequence number
Within a single batch, each reagent tray carries a different number corresponding to the
order of manufacture.
Bar code
Read by the internal bar code reader.
ID
Optional: A blank space is provided to write the sample ID (if required).
3-13
mini VIDAS®
Reagents
System Description and Basic Operations
SPR®
The SPR® is a plastic (polystyrene) device capable of capturing soluble proteins, viruses and
bacteria. It is sealed with a color-coded, barcoded dot perforated in the center. Each SPR® is
disposable.
It eliminates cross-contamination between reagent and instrument and reduces maintenance
to a minimum since there is no tubing, syringe or sampling needle involved.
Each SPR® for a specific assay is identified by a color-coded dot on which a bar code and a
letter and/or digit code representing the assay name are printed.
VIDAS® clinical assays
VIDAS® industry assays
Figure 3-9: Solid phase receptacle (SPR®)
The SPR® is the solid phase base for the immunological reaction. Its interior walls are coated
with antibody or antigen that captures a target analyte.
The target analyte from the sample binds to the SPRs®' interior coating (antibody, antigen,
etc.). It is then bound by an enzyme-conjugated antibody or antigen, forming a «sandwich».
The immobilized enzyme catalyzes the hydrolysis of the substrate into a fluorescent end
product.
The SPR® is used to pipette samples and reagents and perform the following operations:
• sampling
• incubation
• mixing
• washing
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.
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3-14
mini VIDAS®
Reagents
System Description and Basic Operations
Standards / Calibrators and Controls
The standards/calibrators, which are used to calibrate the mini VIDAS® analyzer to each lot,
are available in the reagent kit at one or more concentrations levels depending on the test.
They can be either ready to use or lyophilized (follow the instructions in the reagent package
insert).
Figure 3-10: Vial (control and/or standard/calibrator)
161150-637 - A
3-15
mini VIDAS®
System Basics
System Description and Basic Operations
System Basics
The mini VIDAS® analyzer is a compact, multiparametric, automated immunoanalyzer.
After the samples have been dispensed, the mini VIDAS® analyzer automatically performs
the different stages of analysis, including report printing.
The software processes the reagents using the strips bar codes and can send the results to a
Laboratory Information System (uni-directional interface). The bar code labels on the sample
tubes can be read using an external bar code reader.
Analysis Protocols
The analysis protocol determines a specific sequence of operations required to perform an
analysis. It defines the volume of sample to be aspirated, and the sequence of fluid
manipulations and fluorescence readings. It also manages the mechanical and sensor
functions of the pipettor during sample pipetting.
Principle of a VIDAS® Assay
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device
for the assay. Reagents for the assay are ready-to-use and predispensed in the sealed
reagent strips. All of the assay steps are performed automatically by the instrument. The
reaction medium is cycled in and out of the SPR® several times.
Unbound components are eliminated during the washing steps. During the final detection step,
the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR®. The
conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product 
(4-Methyl-umbelliferone), the fluorescence of which is measured at 450 nm.
The intensity of the fluorescence depends on the concentration of alkaline phosphatase
present on the SPR® that transforms the substrate.
At the end of the assay, results are automatically calculated by the instrument. For some tests,
two detection steps are performed successively.
For antigen detection, the SPR® is generally coated on the interior with capture antibody or
sometimes with a derivative of the analyte. 
For antibody detection, the SPR® is coated with a capture antigen or antibody directed to the
antigen. 
Depending on the test, the conjugate can be a derivative of the analyte or an antibody labeled
with alkaline phosphatase.
For more details, refer to the assay package inserts.
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3-16
mini VIDAS®
System Basics
System Description and Basic Operations
Analysis Methods
The mini VIDAS® analyzer uses several different methods to calculate results. Three basic
categories of analysis methods are:
Calculation method
Description
Test sample to Standard
A comparison of the Relative Fluorescence Value (RFV) of the test
sample to that of a standard. This method is used in Single Reagent
Strip qualitative and most semi-quantitative assays.
Test sample to Reference
A comparison of the RFV of the test sample to that of a reference.
This method is used in Dual Reagent Strip qualitative assays.
Curve Fitting Equations
The RFV of a test sample is mathematically placed on a Calibration
Curve. This method is used for all quantitative and some semiquantitative assays.
Qualitative Assays (Single Reagent Strips)
Two analysis methods are used for single reagent strip qualitative assays: the P/S method and
the P-S method.
In these methods, the “P” stands for the RFV of the test sample and the “S” stands for the RFV
of a standard.
Assay Calibration
Single reagent strip assays are calibrated using one or two standards/calibrators supplied with
the assay kit. Calibration using the standard(s)/calibrator(s) provided in the kit should be run
the first time the assay kit lot is used, after the master lot data have been entered.
If replicate standards are run, their values are averaged. The calibration obtained can be used
for a programmed period of days.
After that, the software automatically expires the calibration, requiring that you run another
one from the same lot.
P/S Method
For assays that use the P/S method, the test value is calculated from the ratio of the sample
RFV to that of the standard RFV.
• RFV (tested sample) = 2158
• RFV (standard) = 2177
• Test value (VT) = 2158/2177 = 0.99
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3-17
mini VIDAS®
System Basics
System Description and Basic Operations
P-S Method
For assays that use the P-S method, the test value is calculated from the difference between
the sample RFV and the standard RFV.
• RFV (tested sample) = 1774
• RFV (standard) = 1689
• Test value (VT) = 1774 - 1689 = 85
Assay Result
In both the P/S and P-S methods, the result of the assay is determined by comparing the test
value to a set of preprogrammed thresholds.
Depending on the assay and the test value result compared to the thresholds, the result can
be either positive, equivocal or negative.
For every assay type, there is a high and low threshold value. The assay result is interpreted
from the test value as follows:
If the test value is:
the result is:
high threshold
Positive
< high threshold and low threshold
Equivocal
< low threshold
Negative
Note: For some qualitative assays (e.g. TOXO Competition, anti-HBc total), the result of the test
value will be negative if the test value is to the high threshold.
Qualitative Assays (Dual Reagent Strips)
Two analysis methods are used for dual reagent strip qualitative assays: the P/N method and
the P-N method.
In these methods, the “P” stands for the RFV of the test sample and the “N” stands for the RFV
of a reference.
Assay Calibration
Dual reagent strip assays do not require separate calibration standards. Instead, the reference
strip serves the same purpose.
P/N Method
For assays that use the P/N method, the test value is calculated from the ratio of the sample
RFV to that of the reference RFV.
• RFV (tested sample) = 2158
• RFV (reference) = 2177
• Test value (VT) = 2158/2177 = 0.99
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3-18
mini VIDAS®
System Basics
System Description and Basic Operations
P-N Method
For assays that use the P-N method, the test value is calculated from the difference between
the sample RFV and the reference RFV.
• RFV (tested sample) = 1774
• RFV (reference) = 1689
• Test value (VT) = 1774 - 1689 = 85
Assay Result
In both the P/N and P-N methods, the result of the assay is determined by comparing the test
value to a set of preprogrammed thresholds.
Depending on the assay and the test value result compared to the thresholds, the result can
be either positive or negative.
If the test value is:
the result is:
high threshold
Positive
< high threshold and low threshold
Equivocal
< low threshold
Negative
Note: For some qualitative assays (e.g. TOXO Competition, anti-HBc total), the result of the test
value will be negative if the test value is to the high threshold.
Quantitative Assays
Quantitative VIDAS® assays use a calibration curve to determine analyte concentrations in
test samples.
Note: Although standards/calibrators can be run after analyses have completed, it is recommended
that they be run either before or with analyses from the same assay kit lot. If an assay has two
standards/calibrators, both must be run at the same time.
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mini VIDAS®
System Basics
System Description and Basic Operations
Principles Of Calibration / Recalibration
The reagents are calibrated according to two different modes, depending on whether the
assays are quantitative or qualitative.
Assay
Description
Quantitative
Calibration is performed at the factory for each new reagent lot and is entered
into the instrument using a bar code provided with each reagent kit. This creates
a «Master Curve» that is stored in memory. It can be readjusted by running a
standard/calibrator. Readjustment of the curve must be validated by testing the
control(s) in the kit. Recalibration should be performed every 14 days or 28 days
depending on reagents.
Qualitative
The result is interpreted by comparing the «Test Value» to one or two threshold
values entered into the mini VIDAS® software.
Calibration
Theoretical Principle for Quantitative Assays
The principle consists of determining the mathematical equation which represents the
calibration curve, i.e. the relationship between the RFV and the concentration of the
standards/calibrators.
Well-defined reference solutions (standards) are used to make this determination. This
calibration curve is established with at least 5 standards/calibrators. It is valid between zero
and the standard/calibrator with the highest titer.
3 mathematical models can be used to establish the master lot curve:
1. 4 logistic parameters or Rodbard model
a1 - a4
RFV =
1 + (c / a3)a2
+ a4
2. Polynomial
ln(c) = a1 + a2 RFV + a3 RFV2 + a4 RFV3
3. Semi-log
RFV = a1 + a2 ln(c)
c represents the concentration.
a1, a2, a3, a4 are the mathematical parameters of the model. They are recalculated for each
calibration.
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3-20
mini VIDAS®
System Basics
System Description and Basic Operations
Principle Applied to the mini VIDAS® analyzer
For the mini VIDAS® analyzer, calibration is performed during the production of each new lot
of SPRs® and reagents. The number of standards/calibrators varies between 5 and 11
depending on the biological assay. Each lot is associated with a particular mathematical
model.
To determine the master curve, the standards/calibrators are tested in seven different runs on
the same mini VIDAS® analyzer. The mean curve of these seven runs becomes the master
curve.
Figure 3-11: Master curve (example)
The master curve is specific for a certain manufacturing lot and biological parameter.
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3-21
mini VIDAS®
System Basics
System Description and Basic Operations
Recalibration
Theoretical Principle
Recalibration consists of establishing a calibration curve from a reference curve and a
standard/calibrator. The reference curve is the master curve used to calibrate reagent lots.
Before use, it must be readjusted to compensate for any minor variations in assay signal
between the mini VIDAS® modules and any possible alteration of the reagent kit.
This readjustment is called recalibration. It may affect the master curve defined at the factory
as well as the calibrator's RFV.
Figure 3-12: Master curve (example)
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3-22
mini VIDAS®
System Basics
System Description and Basic Operations
Principle of Use
Upon receipt of a new lot of reagents, the user must enter the master curve (master lot data)
using the Master Lot Data (bar code) provided with the kit. The standard/calibrator should then
be run to readjust the curve. The controls are tested in the same run to check the recalibration.
Recalibration is valid for 14 days or 28 days depending on reagents, after which, the software
requests another calibration.
To avoid any deviation, the master lot curve is the one set in the factory and not the last curve
readjusted. The software can perfectly manage simultaneous use of several master curves
corresponding to different lots for a given assay.
Figure 3-13: Master curves
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3-23
mini VIDAS®
System Basics
System Description and Basic Operations
Establishing the Master Curve
Each kit includes the master curve in the form of:
•
an MLE bar code printed on the reagent kit label,
•
an MLE card provided in the reagent kit (for certain assays).
The bar code contains the following information:
• 4 RFV levels, corresponding to 4 standards defined in the software. The master curve is
restored using 4 points. The levels of concentration of these 4 standards are known to the
mini VIDAS® software and are specific for each assay.
The mini VIDAS® software replots the total curve using the 4 pairs of concentrations and
RFVs (master lot data).
The remaining information includes:
• the assay code,
• the kit lot number (SPRs® and reagents). It is used to link the master curve data to the
strip lot number,
• mathematical model used to establish the master curve 
(7: Rodbard, 8: Polynomial, 9: Semilog),
• the dose value for the standard (recalibrator) which is essential for calculating the
correction factor. This value may vary slightly from one lot to another,
• range values for the controls in the kit,
• range values for the standard’s RFV,
• maximum variation coefficient of the standard’s RFV duplicates or triplicates.
All these data are specific to an assay and a given lot.
The standard/calibrator must be identified by S1 or S2 (e.g. HBET) or S1 and S2 (e.g.TSH3).
Calibration should be performed each time a new lot is opened (after master lot data have
been entered), and every 14 or 28 days, depending on the reagent.
If the values obtained are not within the acceptable range, an error message appears on the
result sheet.
The control(s) should be tested in single.
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3-24
mini VIDAS®
Overview of Operation Elements
System Description and Basic Operations
Overview of Operation Elements
Strip and SPR® Sections
The mini VIDAS® analyzer contains two compartments called “sections”. Each section
(labeled A and B) can process six single, or three dual, reagent strips for a maximum capacity
of twelve single or six dual tests.
These sections operate independently or linked, allowing a variety of assays to be run on the
mini VIDAS® analyzer at the same time. On each section, a plastic cover can be lifted to
access the reagent strip tray.
Figure 3-14: Strip section
The reagent strip tray consists of six channels into which you can slide a reagent strip. Each of
the six channels constitutes a position in the section.
Up to six reagent strips can be inserted per section for a total combined capacity of up to 12
tests. The tray is pulled into the instrument during processing.
WARNING
The reagent strip trays are movable parts. Use caution to avoid pinch
injuries.
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mini VIDAS®
Overview of Operation Elements
System Description and Basic Operations
The SPR® block has six slots used to hold the Solid Phase Receptacles (SPR®). The six
positions of the block correspond to the six positions of the reagent strip tray.
During processing, the SPR® block and SPRs® form a pipetting device that is used throughout
the assay.
Figure 3-15: SPR® Block
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.
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3-26
mini VIDAS®
Overview of Operation Elements
System Description and Basic Operations
Strip Preparation Tray
A retractable strip preparation tray is located under each reagent strip tray.
Note: Previous versions of the mini VIDAS® analyzer may not have a strip preparation tray.
Figure 3-16: Strip preparation tray
The mini VIDAS® preparation tray can be used to bring the reagents to room temperature.
Caution: 

Never dispense samples into the reagent strips when they are on the strip
preparation tray.
The strip preparation tray should only be used for reagent strips. Do not place
samples on it.
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3-27
mini VIDAS®
Overview of Operation Elements
System Description and Basic Operations
Microprocessor
In addition to the central processing unit, each mini VIDAS® section contains its own
microprocessor. This unit is responsible for storing and operating the assay protocols.
A protocol is a series of commands including all necessary operations for an analysis to be
run. The microprocessor enables the mini VIDAS® analyzer to perform a fully automated
analysis.
Incubator
The assays used in the mini VIDAS® analyzer require temperature control.
Two systems control temperature, one in the reagent strip tray and the other in the SPR®
block.
Note: For more information on temperature monitoring, see Displaying and Printing Instrument
Temperatures on page B-18.
Detection System
The mini VIDAS® detection system consists of an optical fluorimetric scanner. It is mounted
on a mechanical device which enables it to be used on all the sections.
The system detects any chemical changes occurring in the optical cuvette at the end of each
reagent strip.
Optical cuvette
Figure 3-17: Optical cuvette on a reagent strip
Central Processing Unit
The central processing unit controls all aspects of the operations, including data analysis, and
verification of the mechanical and optical systems.
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3-28
mini VIDAS®
Software Basics
System Description and Basic Operations
Software Basics
Menu Structure
The Main Menu is the entry point into the mini VIDAS® software. It also serves as the pathway
to the other mini VIDAS® menus.
Figure 3-18: mini VIDAS® menu structure
A menu accessed from another menu is called a submenu.
Each submenu 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®.
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3-29
mini VIDAS®
Software Basics
System Description and Basic Operations
Selecting a Menu Option
Five selection keys on 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.
The active selection keys are noted by the marker «–» and the enclosed box with a line
extending to a selection key.
The following figure shows the status screen for the two mini VIDAS® sections, A and B.
Figure 3-19: Showing active selection keys
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3-30
mini VIDAS®
Software Basics
System Description and Basic Operations
The Status Screen
The Status Screen display is used to indicate the current status of the two mini VIDAS®
sections and to assign assays to them.
It is also used to display the temperature of each section’s tray and SPR® block.
The First Status Screen
1
2
3
4
Figure 3-20: First status screen
1 — Section labels
2 — Section status (see Table 3-1, Section Status for the different statuses)
3 — The «–» marker: indicates that a selection key is active and that a section can be
selected.
4 — Display temperatures: if you select this key, a screen is displayed showing the internal
temperature of each reagent strip tray and SPR®block.
Table 3-1: Section Status
Section Status
Available
Barcode
Error
Offline
Description
The section is available to be assigned and run tests
The mini VIDAS® analyzer is in the process of reading the bar codes
of the reagent strips in the section.
Indicates a temperature control or hardware problem in the section.
The section has been taken offline.
Resetting
The section is in the process of a hardware reset and is not available.
This status normally lasts for less than one minute.
Run
The section is running tests. When a section is running, the following
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.
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mini VIDAS®
Software Basics
System Description and Basic Operations
Section Status
Description
Starting
The section has completed the preprocessing steps and is preparing to
run tests.
Unload
The section is waiting for the SPRs® 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.
There is an error related to the preprocessing of a reagent strip.
See Start Errors in Appendix - Troubleshooting.
Start error
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.
2 3
4
1
5
Figure 3-21: Second status screen (six positions assigned)
1 — Screen label: this label shows you are looking at the status of section A.
2 — Position numbers: these numbers identify the six positions in the section.
3 — Assay code: these codes appear as tests are assigned to the section or after the strip's
bar code has been read.
4 — Standards/calibrators, control: If a position is assigned to a standard/calibrator or a
control, this type of designator appears.
5 — Start: a selection option to start processing. In other circumstances, this selection may
have another function.
the halt function appears while the section is processing. Use it to stop the processing.
The Third Status Screen
The third status screen is accessed by selecting Display temperatures from the first status
screen. See Displaying and Printing Instrument Temperatures on page B-18.
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3-32
mini VIDAS®
Software Basics
System Description and Basic Operations
Online Help
You can display information on the menu or program you are using by accessing the online
help function.
Pressing
on the keypad activates this function.
a second time, the following screen appears:
If you press
1
2
3
4
Figure 3-22: Help mode screen
1
2
3
4
—
—
—
—
Print Screen: creates a printout of the screen from which you accessed the help function.
System Status: displays the current date/time and the instrument status.
Information: displays the first help screen.
Assay compatibility list: 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.
Viewing Error Messages
The
161150-637 - A
key also functions to display error messages.
3-33
mini VIDAS®
Software Basics
System Description and Basic Operations
Screen Paging
Using the Arrow Keys
As some of the mini VIDAS® displays are too long for one screen, you can page the screen
display using the <> and <> arrow keys.
Figure 3-23: Screen paging
Paging Bar
Some mini VIDAS® screens have a paging bar.
It is used for displays that require several screens. As you page down to the last page, the
solid bar moves down the slot.
Figure 3-24: Paging bar
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3-34
mini VIDAS®
4
System Installation and Configuration
WARNING
The mini VIDAS® analyzer must be installed by bioMérieux Technical
Assistance or your local bioMérieux representative.
WARNING
The mini VIDAS® analyzer weighs 40 kg. Before moving any of the
equipment, it is imperative that you contact bioMérieux Technical
Assistance or your local bioMérieux representative.
Users are trained during installation of the mini VIDAS® analyzer so that they are able to
derive the best performance from it.
Unpacking
Caution: The different components of the mini VIDAS® analyzer must be
unpacked by bioMérieux or by your local bioMérieux representative.
Caution: Keep the packaging materials to ensure protection of the equipment if
ever it needs to be moved.
Caution: The mini VIDAS® analyzer must only be moved by bioMérieux or by
your local bioMérieux representative as fragile components have to be secured
prior to transport.
Caution:
Any damage directly or indirectly resulting from the transport of an instrument
without adequate containers will not be covered by the warranty or maintenance
contract.
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4-1
mini VIDAS®
Storage Conditions
System Installation and Configuration
Storage Conditions
IMPORTANT: It is recommended to keep the original packaging materials in case the equipment
needs to be stored for any period of time.
IMPORTANT: All the equipment, disposables, reagents, etc., must be stored at the temperatures and
in the conditions described in their respective documentation.
Note: The storage temperatures and conditions for the mini VIDAS® analyzer are indicated in
Environmental Conditions on page 3-6.
Choosing A Location
WARNING
Avoid exposing the mini VIDAS® analyzer to direct sunlight, excessive
heat, humidity or dust.
Leave sufficient space around the mini VIDAS® analyzer to allow
airflow that is essential to proper operation of the thermostat.
At a minimum, the instrument requires 10 cm on each side and at the
rear of the instrument.
Do not obstruct the mini VIDAS® analyzer ventilation apertures.
Electrical connections
Refer to Safety Information in Chapter 2 for safety precautions concerning electrical
connections.
Checking Installation
After the mini VIDAS® analyzer has been installed, bioMérieux or your local bioMérieux
representative will perform a test to check that the system is operating correctly.
Connecting an external bar code reader
Caution: Always shut down the mini VIDAS® analyzer before connecting an
external bar code reader.
See Appendix - Installing external hardware for further information on how to connect the bar
code reader.
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4-2
mini VIDAS®
Starting the System
System Installation and Configuration
Starting the System
The mini VIDAS® analyzer may be on 24 hours a day:
•
to avoid incorrect auto-calibration,
•
to enable the temperature of electrical components to remain stable
1. Make sure the mini VIDAS® analyzer is connected to a power outlet.
Figure 4-1: Power switch
2. Turn the mini VIDAS® analyzer power switch to ON.
The power switch is located on the back of the instrument.
CAUTION: The power switch must be easily accessible.

3. Let the mini VIDAS® analyzer warm up for 45 minutes.
4. Turn the power switch to OFF.
5. Wait 1 minute and turn it ON again.
The mini VIDAS® Main Menu appears.
Note: If the room temperature is too low when the mini VIDAS® analyzer is turned on, error 160 will
appear after the initialization phase or when the instrument is restarted (see Instrument
Errors on page B-7).
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4-3
mini VIDAS®
Shutting Down the System
System Installation and Configuration
Shutting Down the System
Introduction
When the mini VIDAS® analyzer is shut down the following data are stored:
•
the mini VIDAS® software application,
•
Protocols,
•
Configuration,
•
Results of the last two calibrations per assay,
•
Master Lot Data.
The following data are erased:
•
Assay results (except calibration results),
•
Error messages.
Procedure
1. Make sure that no analyses are in progress.
2. Make sure that all results have been printed and/or transmitted to the LIS.
3. Turn the mini VIDAS® analyzer power switch to OFF.
4. Disconnect the power cord from the power outlet.
161150-637 - A
4-4
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Configuring the mini VIDAS® analyzer
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.
Selecting a Language
Menus, messages and other information displayed on the mini VIDAS® screen can be
displayed in two different languages, one of which is English. The display language is selected
at the time of installation.
Proceed as follows to select one of the installed languages.
1. Select Configuration menu in the Main Menu.
2. Select Select Language.
A list of languages appears.
Note: If the language you want to install is not in the list, contact bioMérieux or your local bioMérieux
representative.
3. Select the language you want to use.
If no other language is selected at the time of installation, only English will be installed.
The following message appears:
Please wait...
The screen returns to the Configuration Menu.
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4-5
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting Dose Units
This option is used to set the standard units applicable to results for the quantitative VIDAS®
assays.
Caution: After selecting a new unit for an assay, the results for assays run after
this change are automatically calculated with this new unit.
Therefore, always pay particular attention to the units displayed on the results
reports.
1. Make sure that no assays are running.
2. Select Set Dose Units in the Configuration Menu.
A list of assays appears.
Note: If the Show all assays function is not activated, only assays for which the Master Lot data
have been read will be displayed. See Show All Assays on page 4-22.
3. Select an assay for which you want to set the dose units.
If an assay has several versions, a second screen is displayed allowing you to select the
assay version you want. This version is represented by the two characters preceding the
abbreviated assay code (AL or OA in the following example).
On the reagent strip label, the assay version is indicated by the first two characters in the
alphanumeric code printed vertically (OA in the following example).
4. Select the assay version for which you want to set the dose units.
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4-6
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Note: The dose unit currently set is indicated by an arrow.
5. Select the dose unit desired for this assay.
The Configuration Menu appears.
6. Select another assay to set the dose units.
7. Repeat the same procedure.
8. Press
161150-637 - A
to return to the Configuration Menu.
4-7
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting User IDs
This option is used to enter user IDs (up to nine). These IDs will appear automatically on all
reports.
If you do not set a user ID, the user field is left blank on the reports.
1. Select User ID in the Configuration Menu.
2. Press the <Number Key> for the user you want to define.
3. Press the arrow keys to highlight the appropriate character in the character box.
4. Press the Selection key to select the character.
The character appears in the cursor box.
5. Repeat steps 3 and 4 to create an ID.
Note: IDs can contain up to 10 characters.
6. To delete characters, use:
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
7. Press
161150-637 - A
to return to the Set User ID screen.
4-8
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
8. Repeat this procedure to enter another user,
or
Press
to return to the Configuration Menu.
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.
1. Select Report Header in the Configuration Menu.
Note: The space next to the "Z" character can be used to create a space in your header.
2. Press the arrow keys to highlight the appropriate character in the character box.
3. Press the Selection key to select the character.
The character appears in the cursor box.
4. Repeat steps 2 and 3 to create a report header.
Note: Report headers can contain up to 32 characters.
5. To delete characters, use:
• [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.
6. Press
161150-637 - A
to return to the Configuration Menu.
4-9
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting the Date and Time
This option is used to set the date and time for the mini VIDAS® analyzer.
These values appear on the assay report and all other places in the software where the date
or time of day is used.
Caution: Incorrect setting of the date and time can lead to incorrect running of
programs and loss of data.
1. Select Set Date/Time in the Configuration Menu.
2. Set the date and time using the following functions:
• Numeric keypad to fill in the numerical value for a day, month, year, hour or minute.
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
Note: Use
3. Press
161150-637 - A
to validate the numerical values.
to return to the Configuration Menu.
4-10
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting Display Contrast
The liquid crystal display of the mini VIDAS® analyzer has a contrast adjustment to allow for
proper viewing in different room lighting conditions.
Caution: Too much contrast could reduce the life span of your monitor.
It is recommended that you use your mini VIDAS® analyzer for several days with
the original setting before modifying the contrast.
1. Select Set Display Contrast in the Configuration Menu.
2. Press the <> or <> key to adjust the contrast.
The contrast bar and relative contrast level (number in the box) increase or decrease.
The actual display contrast also changes as you make the adjustments.
3. Press
to go back to the default setting
or
Press
161150-637 - A
to return to the Configuration Menu.
4-11
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Selecting the Printer
This option lets you select the internal thermal printer or an external matrix parallel printer.
1. Select Select Printer in the Configuration Menu.
The following selections appear:
•
Internal Printer
•
External Printer
Note: A  symbol indicates the current setting.
2. Select the printer you want to use.
IMPORTANT: Before selecting an external printer, see Appendix - Installing external hardwarefor
external printer installation instructions.
3. Press
161150-637 - A
to return to the Configuration Menu.
4-12
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting the Date/time Format
To set the format of the date and time used on the reports:
1. Select Set Date/Time in the Configuration Menu.
The Date/Time format screen appears:
2. Select Time Separator.
3. Select one of the time separators:
• [:] (colon)
• [.] (period)
• [,] (comma)
The display automatically returns to the Date/Time format screen.
4. Select Date Separator.
5. Select one of the date separator:
• [/] (slash)
• [-] (dash)
• [.] (period)
The display automatically returns to the Date/Time format screen.
6. Select Format.
7. Select one of the date/time formats:
•
•
•
•
•
[HH.MM ddmmm]
[HH.MM ddmmmyy]
[HH.MM yy.mm.dd]
[HH.MM.SS ddmmmyy]
[HH.MM mm.dd.yy]
Note: The date and time separators used in this display are based on your previous selections.
The display automatically returns to the Date/Time format screen.
8. Press
161150-637 - A
to return to the Configuration Menu.
4-13
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Defining the Sample ID Character Sets
This option enables you to define two separate ID sets with three characters.
Use one or both of these sets to input repetitive characters for sample IDs.
1. Select Define Sample ID Character Sets in the Configuration Menu.
The following selections appear:
• Sample ID Set 1
• Sample ID Set 2
2. Select one of the two character sets to define.
The following screen appears.
Note: The space next to the "Z" character can be used to create a space in your ID set.
3. To highlight the appropriate character in the character box, press the arrow keys.
4. Press the Selection key to select the character.
It then appears in the cursor box.
5. Repeat this procedure to add up to three additional characters to the ID.
6. To delete characters, use:
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
7. Press
two times to exit to the Configuration Menu.
or
Press
once and repeat the whole procedure if you want do define the other ID
character set.
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4-14
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Changing the Keyclick Volume
When you press any key on the keypad, there is an audible tone that confirms the keystroke.
1. Select Sound Menu in the Configuration Menu.
2. Select Keyclick Volume in the Sound Menu.
3. Press the arrow keys to adjust the keyclick menu.
The volume bar and relative volume level (number in the box) increase or decrease.
4. Press
to go back to the default setting.
or
Press
161150-637 - A
to return to the Sound menu.
4-15
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
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).
1. Select Sound Menu in the Configuration Menu.
2. Select Beep Volume in the Sound Menu.
3. Press the arrow keys to adjust the beep volume.
The volume bar and relative volume level (number in the box) increase or decrease.
4. Press
to go back to the default setting.
or
Press
161150-637 - A
to return to the Sound menu.
4-16
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Error Beeps
When an error occurs, the mini VIDAS® analyzer begins to beep. The beep grows louder over
a 5 minute period.
You can set the initial and final volume of this error beep.
1. Select Sound Menu in the Configuration Menu.
2. Select Initial Error Volume in the Sound Menu.
3. Press the arrow keys to adjust the initial error beep volume.
The volume bar and relative volume level (number in the box) increase or decrease.
4. Press
to go back to the default setting.
or
Select Test to hear the tone at the adjusted volume.
or
Press
161150-637 - A
to return to the Sound menu.
4-17
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Setting the Final Error Volume
1. Select Sound Menu in the Configuration Menu.
2. Select Final Error Volume in the Sound Menu.
3. Press the arrow keys to adjust the final error beep volume.
The volume bar and relative volume level (number in the box) increase or decrease.
4. Press
to go back to the default setting.
or
Select Test to hear the tone at the adjusted volume.
or
Press
161150-637 - A
to return to the Sound menu.
4-18
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Enabling Display Blinking
A blinking display is associated with the error beep since it only occurs when an error
happens.
When enabled, it causes the display to blink when an error occurs.
1. Select Sound Menu in the Configuration Menu.
2. Select Display Blinking in the Sound Menu.
Note: The current condition of this function is shown with an arrow "" in the selection box.
3. Select the appropriate key.
The display returns to the Sound Menu.
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4-19
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Miscellaneous Items
This option is used to configure various warnings concerning Master Lot data and standards.
Note: In the default configuration, all of the miscellaneous options are enabled except the two for:
- Expired Standard Printed Warnings,
- Autoprint Errors.
1. Select Misc. Items in the Configuration Menu.
2. Press the <> and <> keys to access the option you want to use.
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.
Onscreen Warnings for Expired Standards
1. Select Misc. Items in the Configuration Menu.
2. Select Expired Standard - Onscreen warnings.
The mini VIDAS® analyzer automatically checks for expired calibrations. This procedure
is performed every 24 hours or when the instrument is started up.
If there are any expired calibrations, an error message is displayed.
Note: See Appendix - Troubleshooting for more information on error messages.
Printed warnings for Expired Standards
1. Select Misc. Items in the Configuration Menu.
2. Select Expired Standard - Printed warnings.
The mini VIDAS® analyzer automatically checks for expired calibrations. This procedure
is performed every 24 hours or when the instrument is started up.
If there are any expired calibrations, an error message is displayed and printed (printing
can be configured).
Note: See Appendix - Troubleshooting for more information on error messages.
161150-637 - A
4-20
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Autoprint Errors
1. Select Misc. Items in the Configuration Menu.
2. Select Autoprint Errors.
The mini VIDAS® analyzer will generate a printout when an error occurs. You will still
need to view the error on screen to stop the blinking and beeping.
If you do not select this option, messages are printed only after the user acknowledges the
error.
Note: See Appendix - Troubleshooting for more information on error messages.
Check for Any Standard at Assay Startup
1. Select Misc. Items in the Configuration Menu.
2. Select Check for ANY Standard at assay startup.
The mini VIDAS® analyzer generates a startup error if there are no standard, current or
expired for the selected assay. If an expired standard exists, the assay will start.
Note: See Appendix - Troubleshooting for more information on error messages.
Check for Current Standard at Assay Startup
1. Select Misc. Items in the Configuration Menu.
2. Select Check for Current Standard at assay startup.
The mini VIDAS® analyzer generates a startup error if there are no current standards for
the selected assay.
Note: See Appendix - Troubleshooting for more information on error messages.
Check for Master Lot at Assay Startup
1. Select Misc. Items in the Configuration Menu.
2. Select Check for Master Lot at assay startup.
The mini VIDAS® analyzer generates a startup error if there is no Master Lot data for the
selected assay.
Note: See Appendix - Troubleshooting for more information on error messages.
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4-21
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Show All Assays
1. Select Misc. Items in the Configuration Menu.
2. Select Show all assays.
The mini VIDAS® analyzer will include all of the assays it is capable of running when it
displays an assay selection list.
3. Deselect Show all assays 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® analyzer is restarted.
Beep After Printing
1. Select Misc. Items in the Configuration Menu.
2. Select Beep After Printing.
The mini VIDAS® analyzer will beep discontinuously for a few seconds each time it
generates a printout.
3. Press
161150-637 - A
to return to the Configuration menu.
4-22
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
LIS User Options
This option is used if your mini VIDAS® analyzer 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.
Caution: Your unidirectional connection must be configured and brought into
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.
Enable LIS Upload
1. Select LIS User Options in the Configuration Menu.
2. Select LIS Upload Enabled.
This selection will activate the Laboratory Information System (LIS) upload feature.
Note: A ⊠ symbol indicates a selected option. The ⊠ symbol is removed when you disable a
selected option.
Warn About Missing IDs
1. Select LIS User Options in the Configuration Menu.
2. Select Warn About Missing IDs.
Assays are checked at assay startup.
If an assay does not have an ID, a warning message is generated.
The assay will continue if you acknowledge the message. You can then add an ID to the
assay.
If this option is not selected, no ID warning messages are generated.
IMPORTANT: If you select «LIS upload Enabled», it is recommended that you also select «Warn
About Missing IDs» since any results without IDs will not be transmitted to the LIS.
LIS Auto Validation
1. Select LIS User Options in the Configuration Menu.
2. Select LIS auto validation.
Results will be automatically uploaded to your LIS.
3. Press
161150-637 - A
twice to return to the Main menu.
4-23
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
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 report for the
particular assay type.
1. Select Normal Ranges in the Configuration Menu.
A list of assays displays.
Note: The assays that actually appear may be limited by the Show All Assays configuration option.
2. Press the arrow keys to find an assay.
3. Select the assay with the normal ranges you want to create.
Note: 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.
4. Press the arrow keys to highlight the appropriate character in the character box.
Note: The space next to the "Z" character can be used to create a space in your text.
5. Press the Selection key to select the character for the character box.
The selected character then appears in the cursor box.
6. Repeat steps 4 and 5 to select other characters.
Use these functions as needed:
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
• [Prev.] to switch to the screen for the previous line of text.
7. Press
to switch to the screen for the next line of text,
8. Repeat steps 4 to 7 to enter up to eight lines of text.
9. Press
161150-637 - A
to return to the Configuration menu.
4-24
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Installing Paper in the Internal 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.
1. Select Utility Menu on the Main Menu.
2. Select Misc. Functions.
3. Select Load Printer.
The following message appears:
Load paper now (Press any key to quit)
4. Lift the printer door.
Note: The printer door is on the top of the instrument above the keypad.
5. Retrieve the paper spindle from its slots and put it through the core of the paper roll.
Note: If you have just unpacked the mini VIDAS® analyzer, there may be a piece of tape holding the
spindle. Remove and discard this tape.
6. 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.
7. Push the edge of the paper under the paper feed roller.
A sensor that detects the presence of the paper activates the paper roller.
8. Push the edge of the paper under the paper feed roller.
9. Allow the roller to feed the paper.
It stops automatically after a few seconds.
10. Slide the paper engagement lever to the UPPER end of its slot.
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.
11. Hold the leading edge of the paper in one hand.
12. With the other hand, close the printer door.
161150-637 - A
4-25
mini VIDAS®
Configuring the mini VIDAS® analyzer
System Installation and Configuration
Print Screen
1. Display the page you want to print.
2. Press the
key twice.
3. Select Print Screen to start printing.
4. Press the
161150-637 - A
key to go back to the previous screen.
4-26
mini VIDAS®
5
Workflow and Instructional Procedures
Routine Workflow
161150-637 - A
5-1
mini VIDAS®
Planning a Run
Workflow and Instructional Procedures
Planning a Run
Managing the Job List
The laboratory job list is a list of all assay requests entered and queued pending receipt of the
results.
Assays may be performed on different instruments, so each mini VIDAS® analyzer has its
own job list.
The assay requests have to be created directly on the mini VIDAS® analyzer.
You need to manage tube prioritization and allocation of the assays to be run depending on
the samples to be analyzed.
Defining the Type of Run Required
Your workload and procedural requirements will determine the type of run you use.
There are two ways to run a test with the mini VIDAS® analyzer:
•
«Load and Go» mode:
Start the test and then define its routine information.
The information that the mini VIDAS® analyzer requires is taken from the labels on the
reagent strips during the initial steps of the run.
The Sample ID, standard(s)/calibrator(s) or control(s), dilution factor can be entered after
the run has been started.
•
«Defined» mode:
Enter routine information before running the test.
In addition to the assay type, Sample ID, standard(s)/calibrator(s) or control(s), dilution
factor can be entered prior to starting a defined run.
Checking Assay Compatibility
The mini VIDAS® analyzer allows you to run different assays in the two sections at the same
time as long as these assays have the same protocol.
1. Press
twice from any screen.
A help screen appears.
2. Select Assay compatibility list.
The assays listed in the same column are compatible with one another. If an assay is not
on this list, it is not compatible with any other assay.
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5-2
mini VIDAS®
Planning a Run
Workflow and Instructional Procedures
Defining the Standards/calibrators and Controls to be used
CAUTION: To obtain a result, it is important to use a valid standard/calibrator.
Standards/calibrators
All single strip reagent assays require that a standard/calibrator assay result be stored in the
mini VIDAS® analyzer.
A standard/calibrator must be included in a run when:
•
you are running an assay kit lot for the first time,
•
the previous standard/calibrator for the lot you are using was run over 14 or 28 days ago
(depending on assays) and has therefore expired.
Controls
For qualitative assays, Positive and Negative Controls are provided in all VIDAS® assay kits.
For quantitative assays, controls with targeted value are provided in all VIDAS® assay kits.
Controls should be tested routinely according to your laboratory’s regulatory guidelines.
Always refer to the reagent package insert for more information.
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5-3
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Running Assays
Before running assays, carefully read the precautions described in Precautions For Use Of
Reagents on page 2-11.
Entering Master Lot Data
Before each new lot of reagents is used, specifications (or factory master data) must be
entered into the mini VIDAS® analyzer using the Master Lot Entry (MLE) data.
The master lot data only needs to be entered once for each lot.
Master Lot data can be entered into the mini VIDAS® analyzer automatically using:
•
the Master Lot Entry (MLE) data printed on the reagent kit label.
This bar code can only be read using the hand-held bar code reader connected to the
instrument
•
the Master Lot Entry (MLE) card provided in the VIDAS® assay kit (for certain assays).
Note: The mini VIDAS® analyzer uses a check code to verify the Master Lot data entered manually
and by the bar code reader.
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5-4
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Scanning Master Lot Data on the Reagent Kit Label
Before reading the bar code, check that:
•
The bar code reader has been installed and configured. 
If not, see Appendix - Installing external hardware.
•
The reagent kit label is in good condition.
To be readable the bar code must be complete, free of stains or tears.
If the label is stained or torn, contact bioMérieux or your local bioMérieux representative.
1. Select Master Lot Menu in the Main Menu.
2. Select Scan Master Lot.
The Master Lot screen appears:
3. Using the bar code reader, scan the bar code printed on the reagent kit label.
Note: Older bar code readers may require that you slowly scan the bar code on the kit label from top
to bottom or bottom to top until the code has been read completely.
A message is displayed that reading is in progress.
The reader beeps when the reading is finished.
If the bar code is read correctly, the display returns to the Master Lot Menu.
Entering the Master Lot Data is now complete and a report showing the main characteristics of
the lot is automatically printed.
In case of problem when reading the Master Lot Entry (MLE) bar code,
161150-637 - A
•
if the kit does not contains the Master Lot Entry (MLE) card, contact bioMérieux or your
local bioMérieux representative.
•
if the kit contains the Master Lot Entry (MLE) card, perform the manual data entry
procedure (see Manually Entering Master Lot Data Using the Master Lot Entry (MLE)
card. on page 5-7).
5-5
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Automatically Entering Master Lot Data Using the Master Lot Entry (MLE) card
IMPORTANT: Some VIDAS® reagent kits no longer include the Master Lot Entry (MLE) Card.
Refer to Scanning Master Lot Data on the Reagent Kit Label.
The Master Lot Entry (MLE) card is placed into a specially designed holder and then inserted
into a section of the mini VIDAS® analyzer.
Note: The data are presented in two forms: machine-readable bar codes and alphanumerics. This
allows for manual data entry or correction if the machine cannot read all of the bar codes.
1. Select Master Lot Menu in the Main Menu.
2. Select Read Master Lot.
The list of available sections appears.
3. Place the Master Lot Entry (MLE) card in the reagent strip tray of the section you will use.
Note: The status of the selected section must be “Available”.
4. Select the appropriate section.
The mini VIDAS® analyzer reads the bar coded data from the card and the screen returns
to the Master Lot Menu.
Entering the Master Lot Data is now complete and a report showing the main characteristics of
the lot is automatically printed.
If the instrument is unable to read all the data on the card, the mini VIDAS® analyzer beeps
and an error message is generated.
1. Make sure the Master Lot Entry (MLE) Card is properly oriented in the tray and perform
this procedure again.
If the instrument again fails to read the data, perform the manual data entry procedure (see
Manually Entering Master Lot Data Using the Master Lot Entry (MLE) card. on page 5-7).
161150-637 - A
5-6
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Manually Entering Master Lot Data Using the Master Lot Entry (MLE) card.
CAUTION: There is a risk of error when entering the Master Lot Data manually.
Make sure that you enter the lines in exactly the same order as they appear on the
Master Lot Entry (MLE) card.
IMPORTANT: Some VIDAS® reagent kits no longer include the Master Lot Entry (MLE) Card.
Refer to Scanning Master Lot Data on the Reagent Kit Label
There are two reasons for manually entering Master Lot data:
•
when you want to correct bar codes read incorrectly by the mini VIDAS® analyzer (see
Correcting Bar codes Manually on page 5-7),
•
when you want to enter the information manually (see Entering Bar codes Manually on
page 5-10).
Note: Data can be read using the bar code reader. However, new models of bar code readers
cannot read bar codes printed on the Master Lot Entry (MLE) card.
Correcting Bar codes Manually
1. Select Master Lot Menu in the Main Menu.
2. Select Manual Master Lot Entry.
The following screen appears:
Note: The numbers "1/16" on the screen indicate that there is a total of 16 bar codes on the Master
Lot data card, and, in the example shown, bar code  1 is bad.
3. Select <Clr> to clear the bar code window of the message «BAD».
4. Find the appropriate bar code on the Master Lot Data card.
161150-637 - A
5-7
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
The figure below shows a portion of a sample card with the 16 machine-readable bar codes
and matching alphanumeric strings.
5. Enter the correct bar code by typing the characters of the bar code manually.
6. Press the arrow keys to highlight the appropriate character in the character box.
7. Select the character.
The character appears in the cursor box.
8. Press a <Number Key> to place a number in the cursor box.
9. Continue this for all nine characters in the bar code.
10. Use these functions as needed:
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
• [Prev.] to go back to the previous bar code.
(do not mistake this key for the
key on the keypad).
Note: "O" and "I" are letters.
"Ø" and "1" are the digits zero and one.
11. Press
when the bar code entry is complete.
The mini VIDAS® analyzer checks the bar code.
161150-637 - A
5-8
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
If the bar code was entered correctly and there are no other errors, the display exits to the
Master Lot Menu.
Entry of this Master Lot Data is complete.
The Master Lot Data report showing the main characteristics of the assays is printed
automatically.
If you entered the bar code incorrectly, or if other bar codes need to be corrected, the following
prompt appears:
MLE Card data bad.
Edit again?
12. Select Yes to continue the entry process.
The manual bar code entry screen appears again.
The digits, indicating the bar code number from 1 to 16, are displayed.
13. Repeat this procedure to correct other bar code(s) if necessary.
161150-637 - A
5-9
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Entering Bar codes Manually
1. Select Master Lot Menu in the Main Menu.
2. Select Manual Master Lot Entry.
The following screen appears:
Note: The numbers "1/16" on the screen indicate that there is a total of 16 bar codes on the Master
Lot data card, and, in the example shown, you are entering bar code  1.
The figure below shows a portion of a sample card with the 16 machine-readable bar codes
and matching alphanumeric strings.
3. Enter the first bar code on the Master Lot Entry (MLE) card by typing the characters of the
bar code manually.
4. Press the arrow keys to highlight the appropriate character in the character box.
161150-637 - A
5-10
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
5. Select the character.
The character appears in the cursor box.
6. Press a <Number Key> to place a number in the cursor box.
7. Continue this for all nine characters in the bar code.
8. Use these functions as needed:
• [Clr] to clear the cursor box.
• [] to delete one character in front of the cursor.
• [Prev.] to go back to the previous bar code.
(do not mistake this key for the
key on the keypad).
Note: "O" and "I" are letters.
"Ø" and "1" are the digits zero and one.
9. Press
.
10. Enter the second bar code on the Master Lot Entry (MLE) card.
11. Press
.
12. Repeat this procedure for the following bar codes.
13. Press
after having entered the last bar code (entry zone 16/16).
The mini VIDAS® analyzer checks the bar codes.
The Master Lot Data report is printed automatically.
161150-637 - A
5-11
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Running Assays in «Load and Go» Mode.
CAUTION: When calibration is performed, the standard/calibrator and/or controls
must be identified. In this case, only «Defined» mode will be used.
CAUTION: When different assays use the same strip (eg.: VIDAS® LYG and
VIDAS® LYGS), the assay must be selected prior to the run. If no assay is
selected, a start error occurs and the run is stopped.
1. Check that a calibration has been run for this assay.
2. Make sure that the appropriate samples have been inoculated into the assigned strips.
CAUTION: It is very important to respect the required volume indicated in the
assay package insert.
Loading Reagent Strips and SPRs®
CAUTION: Strips and SPRs® should not be loaded in advance but just before the
test is performed as preincubation in the sections can affect results.
However, certain tests require preincubation, so the strips need to be incubated in
the instrument (refer to the reagent package insert). 
1. Lift the cover of the reagent strip section.
2. Hold the strip by its handle and insert it into a test position.
3. Slide the strip into the section channel.
CAUTION: Make sure the strip is firmly placed by sliding it all the way until you feel
the strip lock into the section channel. 
4. Open the SPR® block door.
161150-637 - A
5-12
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
5. Place the SPR® in the SPR® block position directly over the reagent strip.
CAUTION: When placing the SPR® in the SPR® block position, do not apply
pressure to the block position as this may cause the SPR to be ejected.
Check the position of SPRs® and reagent strips. The SPR® color-coded dot must
match the dot on the reagent strip.

It is very important that all the SPRs® for the assay you want to run are properly
placed in the SPR® block and that the dot on top has a hole.

The mini VIDAS® analyzer cannot detect the type of SPR® used nor the absence
or presence of an SPR®.
6. Repeat this procedure for other strips and SPRs® to be loaded.
7. Close the SPR® block door and the reagent strip tray cover.
Starting A «Load and Go» Run
1. Select Start Section on the Main Menu.
2. Select the section(s) you want to run.
Note: If two or more user IDs have been defined, the following screen appears.
If only one user ID was defined, that ID appears on the assay report.
If no user IDs were defined, no ID is included on the assay report.
See Setting User IDs on page 4-8 for more information.
3. Press the <Number Key> for the user ID assigned to this section.
The following message appears:
Starting Section
Please wait...
161150-637 - A
5-13
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
The status of the started section now displays «Barcode».
4. Press
to return to the Main Menu.
Note: The Sample ID, standard(s)/calibrator(s) or control(s), dilution factor can be entered after the
run has been started.
5. After the assays are completed, remove the SPRs® and strips from the mini VIDAS®
analyzer.
6. Dispose of the used SPRs® and strips into an appropriate receptacle.
161150-637 - A
5-14
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Running Assays in «Defined» mode
1. Make sure that the appropriate samples have been inoculated into the assigned strips.
IMPORTANT: It is very important to respect the required volume indicated in the assay package
insert.
Assigning Assays to a Position
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
3. Press the <Number Key> for the position where you want to place a reagent strip.
Note: Dual reagent strips MUST be placed in positions 1 & 2, 3 & 4, or 5 & 6. Placing one in
positions 2 & 3, for example, causes an error.
4. Select Assay.
161150-637 - A
5-15
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
5. Select Select Assay.
An assay code list appears.
Note: The assays that actually appear may be limited by the Show All Assays configuration option.
See Show All Assays on page 4-22.
Note: If an assay has already been selected for the section, the assay code list only includes the
assays compatible with the previously selected assay and with the other assays that have the
same name.
6. Scroll the list using the arrow keys to select the assay code.
The Position screen appears with the assay code now included.
161150-637 - A
5-16
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning Standards/calibrators for Assays with one standard/calibrator
Always refer to the reagent package insert for more information on the standard(s)/
calibrator(s) to be run for an assay.
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
The Section screen appears displaying the six positions in the section.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select S on the Position screen.
The following prompt appears:
Enter standard number (1-4)
5. Select «1» or «2» on the numerical keypad (depending on the kit: eg for HBET).
S1 or S2 is created automatically and appears on the screen.
6. Press
.
7. Repeat steps 4 to 6 if the standard/calibrator must be run in duplicate (S1 S1) or in
triplicate (S1 S1 S1).
161150-637 - A
5-17
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning Standards/calibrators for Assays with two standards/calibrators (S1 and S2)
Always refer to the reagent package insert for more information on the standard/calibrator to
be run for an assay.
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
The Section screen appears displaying the six positions in the section:.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select S on the Position screen.
The following prompt appears:
Enter standard number (1-4)
5. Select «1» on the numerical keypad.
S1 is created automatically and appears on the screen.
6. Press
.
7. Repeat steps 4 to 6 if S1 must be run in duplicate or in triplicate.
8. Select S on the Position screen.
9. Select «2» on the numerical keypad.
S2 is created automatically and appears on the screen.
10. Press
.
11. Repeat the steps 8 to 10 if S2 must be run in duplicate or in triplicate
Note: Multiple standards/calibrators with the same ID number are considered to be replicates by the
mini VIDAS® analyzer.
The number of replicates to be performed for each standard/calibrator is indicated in the
reagent package insert.
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5-18
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning Controls to a Position
Always refer to the reagent package insert for more information on controls.
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
The Section screen appears displaying the six positions in the section.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select C on the Position screen.
Note: If your mini VIDAS® analyzer has been configured to run internal quality controls and to send
them to a web application for statistical processing, the Position screen will display Controls
instead of C. In that case, select Controls, then select C to enter controls.
The following prompt appears:
Enter Control number (1-4)
5. Press the <Number Key> for the ID number for the control.
161150-637 - A
5-19
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning Sample IDs to a Position using a Bar code Reader
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
The Section screen appears displaying the six positions in the section.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select Sample ID.
5. Scan the sample bar code label with the bar code reader.
The sample ID now appears on the screen.
6. Repeat the whole procedure to enter other sample IDs.
7. After identification of the last sample, press
displayed on the screen
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5-20
until the work list for the section is
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning Sample IDs to a Position Manually
Note: Sample IDs may contain a maximum of 12 alphanumeric characters.
1. Select Status Screen from the Main Menu.
2. Select a section.
The Section screen appear.
Note: A section must have an “Available” status in order for you to proceed.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select Sample ID.
5. Press the arrow keys to highlight the appropriate character in the character box.
6. Select the character.
The character appears in the cursor box.
7. Press a <Number Key> to place a number in the cursor box.
8. Select one of the two sample ID character sets if you want to place one of these in the
cursor box.
Note: See Defining the Sample ID Character Sets on page 4-14 fore more information.
9. Repeat these steps until the sample ID for the test is complete.
161150-637 - A
5-21
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
10. Press
to validate the sample ID and to go to the next position if other sample IDs
must be entered.
11. Repeat the whole procedure to enter other sample IDs.
12. After identification of the last sample, press
displayed on the screen.
until the work list for the section is
Defining the Same Assay Type for the next position
If the Assay Type has been selected,
1. Press
to copy the same assay type for the next position.
Erasing Inputs for a Position or a Section
1. Select Status Screen from the Main Menu.
2. Select a section.
Note: A section must have an “Available” status in order for you to proceed.
The Section screen appear.
3. Press the <Number Key> for the position where you want to place a reagent strip.
4. Select Assay in the Position screen.
5. Select Clear.
6. Select Clear this position's setup only or Clear entire section's setup.
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5-22
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Loading Reagent Strips and SPRs®
CAUTION: Strips and SPRs® should not be loaded in advance but just before the
test is performed as preincubation in the sections can affect results.
However, certain tests require preincubation, so the strips need to be incubated in
the instrument (refer to the reagent package insert). 
1. Lift the cover of the reagent strip section.
2. Hold the strip by its handle and insert it into a test position.
3. Slide the strip into the section channel.
CAUTION: Make sure the strip is firmly placed by sliding it all the way until you feel
the strip lock into the section channel. 
4. Open the SPR® block door.
5. Place the SPR® in the SPR® block position directly over the reagent strip.
CAUTION: When placing the SPR® in the SPR® block position, do not apply
pressure to the block position as this may cause the SPR to be ejected.

Check the position of SPRs® and reagent strips. The SPR® color-coded dot must
match the dot on the reagent strip.

It is very important that all the SPRs® for the assay you want to run are properly
placed in the SPR® block and that the dot on top has a hole.

The mini VIDAS® analyzer cannot detect the type of SPR® used nor the absence
or presence of an SPR®.
6. Repeat these steps for other strips and SPRs® to be loaded.
7. Close the SPR® block door and the reagent strip tray cover.
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5-23
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Starting a «Defined» Run
Note: Sections can be started individually or together.
The only difference is in defining the user ID. Sections started together will use the same user
ID; those started individually can use different user IDs.
Starting Sections Individually
1. Select Start in the concerned section screen.
Note: If two or more user IDs have been defined, the following screen appears.
If only one user ID was defined, it appears on the assay report.
If no user IDs were defined, no ID appears on the assay report.
See Setting User IDs on page 4-8 for more information.
2. Press the <Number Key> for the user ID assigned to this section.
The following message appears:
Starting Section
Please wait...
The status of the section displays «Barcode».
3. Press
161150-637 - A
to return to the Main Menu.
5-24
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Starting Sections Together
1. Select Start Section on the Main Menu.
2. Select All Sections.
Note: If two or more user IDs have been defined, the following screen appears.
If only one user ID was defined, it appears on the assay report.
If no user IDs were defined, no ID appears on the assay report.
See Setting User IDs on page 4-8 for more information.
3. Press the <Number Key> for the user ID assigned to this section.
The following message appears:
Starting Section
Please wait...
The status of the sections displays «Barcode».
4. Press
to return to the Main Menu.
Unloading Reagent Strips and SPRs®
1. After the assays are completed, remove the SPRs® and reagent strips from the mini
VIDAS® analyzer.
2. Dispose of the used SPRs® and reagent strips into an appropriate receptacle.
IMPORTANT: When unloading the Reagent strips and SPR, carefully read the precautions described
in Precautions For Use Of Reagents on page 2-11, section «At the End of the Run».
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5-25
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Assigning a Dilution Factor
Note: Standards/calibrators, controls and qualitative assays should not be diluted.
Use this feature to assign a dilution factor to an individual test.
Report printouts indicate when a dilution factor is being used. On this screen, a number will
appear in a box next to the section if a dilution factor is used.
A dilution factor can be assigned or changed at any time before the completion of a run.
IMPORTANT: You should perform sample dilution manually using the dilution factor memorized by
the mini VIDAS® analyzer.
1. Select Status Screen on the Main Menu.
2. Select a section.
3. Press the <Number Key> for the position to which you want to assign a dilution factor.
Note: If the position contains an assay that should not be diluted, the Dilution option does not
appear on the Position screen.
If you attempt to dilute a standard/calibrator or a control, that designation is removed and the
test becomes a normal assay.
4. Select Dilution.
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5-26
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
5. Enter a dilution factor between 1 and 999.
6. Press
.
The Position screen appears with the new dilution factor displayed.
7. Press
to return to the Section screen.
8. Repeat this procedure to assign dilution factors to additional positions in the section.
9. Press
161150-637 - A
to return to the Main Menu.
5-27
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Running Internal Quality Controls (for Clinic Use Only)
The mini VIDAS® analyzer allows you to run internal quality controls and to send them to a
web application where the results will undergo intra- and inter-laboratory statistical processing.
IMPORTANT: Since this function is optional, certain menus will not be displayed if you have not
subscribed to this service through bioMérieux.

Only a bioMérieux representative can configure the mini VIDAS® software to run and
send internal quality controls.

Internal quality controls can only be performed on quantitative assays.
1. Select Status screen from the Main Menu.
2. Select a section.
The selected section screen appears.
3. Select a position.
The Position screen appears.
4. Select the assay for which you want to run an internal quality control.
5. Select Controls.
6. Select QC.
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5-28
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
7. Press the <Number Key> for the level of the internal quality control.
8. Enter the lot number of the internal quality control you want to run.
Note: If an internal quality control with the same level has already been performed for this assay, the
software will display the lot number of the last internal quality control that was run for that level.
9. Press
.
10. Repeat this procedure to define another internal quality control.
11. When all the positions in a section are defined, press the
Section screen.
key to return to the
12. Start the section.
Note: To transfer internal quality controls results, refer to Validating Internal Quality Controls
Transfers (for Clinic Use Only) on page 6-11.
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5-29
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Viewing Stored Standards/calibrators
Use this procedure to view the standards/calibrators for a particular assay lot.
1. Select Master Lot Menu in the Main Menu.
2. Select List Stored Stds.
An assay code list appears.
3. Select the assay code.
4. Press
to view additional standards/calibrators (if any) for this assay type.
A screen appears displaying information on the stored standard/calibrator for the selected
assay.
5. Select Delete to delete the stored standard/calibrator shown.
The following prompt appears:
Standard will be deleted.
Are you certain?
6. Select Yes to delete the stored standard/calibrator.
7. Press
161150-637 - A
to return to the Master Lot Menu.
5-30
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Viewing Master Lot Data
Use this procedure to display the master lot data entered.
1. Select Master Lot Menu in the Main Menu.
2. Select List Master Lots.
A list of assays appears for which master lot data exists.
3. Select an assay code to display master lot data.
A screen appears displaying information on the stored master lot data for the selected
assay.
Note: If there is more than one lot that has master lot data, a lot selection screen appears first.
4. Press any key to return to the Assay Code List.
5. Repeat this procedure to select another assay code for which you want to display Master
Lot data.
or
Press
161150-637 - A
to return to the Main Menu.
5-31
mini VIDAS®
Running Assays
Workflow and Instructional Procedures
Stopping a Section
CAUTION: You must discard the strips and SPRs® that are in a section that has
been stopped.
Use this procedure to stop processing one or more sections.
Note: The stop option is also available on the first status screen, accessed via the Status Screen
selection in the Main Menu. This stop option is only available while a section is running.
1. Select Utility Menu in the Main Menu.
2. Select Halt Section.
3. Select one of the sections to stop.
The following selections appear:
Halt (clear setup)
Halt (retain setup)
4. Select the Halt (clear setup) option to stop the section and erase the tests defined in the
positions. Use this option when the tests will not be run again.
or
Select the Halt (retain setup) option to stop the section and retain the tests defined in the
positions. Use this option when the tests will be run again.
The Utility Menu appears again.
5. Press
161150-637 - A
twice to return to the Main Menu.
5-32
mini VIDAS®
6
Results and Reports
The Assay Reports
When the run for a section is completed, the mini VIDAS® analyzer automatically prints an
assay report.
The report is printed on the internal printer or on the optional external printer, depending on
how printers are configured.
All assay reports are similar, but not identical. Slight differences occur, depending on the
assay type.
Report Header
The figure below shows a sample of a report header that contains information common to all
reports.
1
2
3
4
5
6
7
8
9
10
11
Figure 6-1: Example of a result report header
1 —
2 —
3 —
4 —
5 —
6 —
7 —
8 —
9 —
10 —
11 —
The report title
The custom report header you can enter in the appropriate configuration option.
The identity of the section, A or B.
Date and time the assay completed.
Technologist ID, from the appropriate configuration option.
Name (and code) of the assay.
Version of the mini VIDAS software (Ver).
Assay kit lot number.
Information on the standard/calibrator used.
Date and time the standard/calibrator was run.
Mean RFV of the standard/calibrator.
Note: Information concerning the standard/calibrator (lines 9, 10 and 11) do not appear on reports
for dual reagent strip Assays.
161150-637 - A
6-1
mini VIDAS®
The Assay Reports
Results and Reports
Qualitative Assays Results
Results are compared to the threshold provided by the Master Lot data and adjusted by
standards during calibration.
The result is either:
•
Negative
•
Positive
•
Equivocal
Figure 6-2: Example of a qualitative result report
1
2
3
4
5
6
7
161150-637 - A
—
—
—
—
—
—
—
Software and protocol version
Reagent lot number
Mean of S1 Relative Fluorescence Value
Cut off
Initial strip’s Relative Fluorescence Value
Final Relative Fluorescence Value
Interpretation
6-2
mini VIDAS®
The Assay Reports
Results and Reports
Figure 6-3: Example of a qualitative result report
Note: For dual reagent strip, «Reference» is reported next to the position of the test strip.
161150-637 - A
6-3
mini VIDAS®
The Assay Reports
Results and Reports
Quantitative Assays Results
Results are compared to the master curve provided by Master Lot data and adjusted by
standards/calibrators during calibration.
The result is a concentration given in the chosen unit.
Figure 6-4: Example of a quantitative result report
1
2
3
4
161150-637 - A
—
—
—
—
Software and protocol version
Reagent lot number
Relative Fluorescence Value
Result concentration
6-4
mini VIDAS®
The Assay Reports
Results and Reports
Assay Report Errors
The mini VIDAS® assay report is designed to display error messages whenever a result does
not conform to the internal requirements that are programmed for each assay.
On the report, any values found to be outside control ranges are noted.
An error message is then printed at the bottom of the report.
Figure 6-5: Assay report error (example)
1 — Noted value.
Note the “§” symbol next to the value. Different symbols are used for different error
messages.
2 — Note and error message.
In this case, the error message is: «High reading»
3 — The test result has been flagged as «INVALID» due to the type of the error.
Note: See Appendix - Troubleshooting for a listing of the error messages.
161150-637 - A
6-5
mini VIDAS®
Reprinting an Assay Report
Results and Reports
Reprinting an Assay Report
Note: Only those tests stored in the mini VIDAS® analyzer memory are available for reprinting. If
the mini VIDAS® analyzer is turned off, stored results are no longer available.
The mini VIDAS® analyzer can store up to 48 results. 
For example, all 48 results can be from one section, or they can be divided between the two
sections in any combination. The total, however, cannot exceed 48 (6 results x 8 sections).
The storage system works on a «First In, First Out» basis. This means that the results of the
last eight sections are the ones that are stored.
When the results of the ninth section are stored, the first results of the first section to be stored
are deleted.
Reprinting an Assay Report without Editing Data
1. Select Results Menu in the Main Menu.
2. Select Reprint Results.
3. Select one or more sections to reprint.
Note: The  symbol appears in the box for the selected section(s).
4. Press
to print your selection.
The following prompt appears:
Edit the data before reprinting?
5. Select No to reprint the selected section without viewing the assays run before reprinting
results.
The display returns to the Results Menu.
After a few seconds, the results print out.
161150-637 - A
6-6
mini VIDAS®
Reprinting an Assay Report
Results and Reports
Editing Data before Reprinting an Assay Report
1. Select Results Menu in the Main Menu.
2. Select Reprint Results.
3. Select one or more sections to reprint.
Note: The  symbol appears in the box for the selected section(s).
4. Press
to print your selection.
The following prompt appears:
Edit the data before reprinting?
5. Select Yes to view one or more positions in a section before reprinting results.
6. Press a digit, 1 to 6, on the keypad to recalculate the results of this section using a more
recent standard.
161150-637 - A
6-7
mini VIDAS®
Reprinting an Assay Report
Results and Reports
The following prompt appears:
Replace the Standard currently used by this report for this
assay with the most recent stored Standard?
7. Select Yes to replace the standard/calibrator currently used.
Note: If you select No, the report will print with the standard/calibrator currently used. The screen will
then return to the next section for editing.
The following message appears:
Retrieving most recent Standard
Please wait....
The screen returns to the Section screen for further editing.
Note: After recalculation, you cannot retrieve the original standard/calibrator.
8. Press
to edit the next section.
When all sections have been printed, the screen returns to the Results Menu.
9. Press
161150-637 - A
to return to the Main Menu.
6-8
mini VIDAS®
Validating LIS Results
Results and Reports
Validating LIS Results
The mini VIDAS® software has a unidirectional interface which allows results to be uploaded
to the Laboratory Information System (LIS).
You can access results to be uploaded when the option «LIS auto validation» is not
activated.
CAUTION: Notes associated with the results are not uploaded to the LIS. They
only appear at the bottom of result reports.
Note: There cannot be more than 8 sections in the LIS validation queue.
If this queue is full, a warning message will appear when you start additional assays.
The message will warn you that the assay you are about to start will not be placed in the LIS
validation queue unless you validate some assay results. However, the results will still be
printed.
1. Select Results Menu in the Main Menu.
2. Select Validate LIS results.
2
3
1
5
7
6
4
1
2
3
4
—
—
—
—
Section number
Date / time the results were completed
Sample identifier
Send
A selection option to upload results to the LIS queue.
5 — Check boxes
• When a result is invalid, it is shown on the screen but does not include a check
box.
• When the box is checked, the position is validated for LIS upload.
The position will not be validated when there is an expired reagent kit lot, expired
calibration standard or a result based on calibration with a single standard.
6 — Position numbers
7 — Assay code
Assay being run in a position.
3. Press the <Number Key> for the position to be validated.
4. Select Send to upload the results to the LIS.
The screen will display the other results that need to be validated.
161150-637 - A
6-9
mini VIDAS®
Validating LIS Results
Results and Reports
5. Repeat this procedure to upload other results to the LIS.
When all the validated results have been uploaded, the screen returns to the Results Menu.
Canceling Uploads of Results to the LIS
1. Select Results Menu in the Main Menu.
2. Select Validate LIS results.
3. Press the <Number Key> for the position number with the box checked.
The  will be removed indicating that the test result will not be uploaded to the LIS.
Deleting the Remaining Non-validated LIS Upload Data
1. Select Results Menu in the Main Menu.
2. Select Validate LIS results.
3. Press
.
The following message appears:
Delete the remaining non-validated LIS upload data ?
Are you certain ?
4. Select Yes.
The screen returns to the Results Menu.
5. Select No to cancel deletion.
The screen will display the other results that need to be validated.
Stopping Validation
1. Select Results Menu in the Main Menu.
2. Select Validate LIS results.
3. Press the <Number> key that corresponds to the position to be validated.
4. Press
.
The following message appears:
Validation aborted.
Current Section’s results NOT validated.
The screen returns to the Results Menu.
5. Press
to return to the Main Menu.
Note: A result can only be uploaded once (unless the section results are reprinted).
CAUTION: If you turn OFF the mini VIDAS® analyzer, the memory will refresh
and results will be lost.
161150-637 - A
6-10
mini VIDAS®
Validating Internal Quality Controls Transfers (for Clinic Use Only)
Results and Reports
Validating Internal Quality Controls Transfers (for Clinic Use Only)
Internal quality controls can be sent to a Web application where statistical processing will be
performed on the results.
See Running Internal Quality Controls (for Clinic Use Only) on page 5-28 for further details.
1. Select Results Menu in the Main Menu.
2. Select Validate QC results.
3. The following screen appears (if the «internal quality controls» function is activated).
4. Select more internal quality controls results to be transferred to the Web based
application.
The  symbol will appear in the box for each selected result.
5. Press
.
To delete the remaining non-transferred results of internal quality controls,
1. Select more internal quality controls results to be deleted.
The  symbol will appear in the box for each selected result.
2. Press
.
3. Select Delete,
or
Select Cancel.
Note: If you select Delete, a message will display asking you to confirm the deletion. The screen will
return to the Main Menu. If you select Cancel, you will cancel the request and return to the
Results menu.
Note: A result can only be uploaded once (unless the section results are reprinted).
If results are reprinted, they can also be recalculated.
See Reprinting an Assay Report on page 6-6.
161150-637 - A
6-11
mini VIDAS®
Printing the mini VIDAS® Assay List
Results and Reports
Printing the mini VIDAS® Assay List
Use this procedure to print a list of the mini VIDAS® assays that have Master Lot Data loaded
on your mini VIDAS® analyzer.
The assay list includes the complete name of each assay and its assay code.
Assays in the list are grouped by compatible protocols.
1. Select Results Menu in the Main Menu.
2. Select Print Assay List.
The following message appears for a moment:
Constructing assay list printout.
Please wait
The assay list then begins to print and the display returns to the Results Menu.
A portion of an assay list printout appears below.
Figure 6-6: A sample of the assay list printout.
161150-637 - A
6-12
mini VIDAS®
7
Miscellaneous Operations
Taking a Section Off line
An off-line section is not available for running assays. The operating temperature remains the
same whether a section is off-line or on-line.
Note: Use the same procedure to place an off-line section on-line. The section will be available for
use immediately after it has been put back on-line.
1. Select Utility Menu in the Main Menu.
2. Select On/Off line.
3. Select one of the sections to place off-line.
The display returns to the previous menu.
Note: You can confirm the off-line status of a section by selecting Status Screen on the main menu.
The first screen shows the status of each section.
4. Press
to return to the Utility Menu.
Changing Factory Settings
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 factory settings control various physical parameters that affect the keypad and display
screen.
All of the factory-set parameters are found on the Configuration Menu.
This section contains the procedures needed to change these parameters from the values set
by bioMérieux.
Note: We suggest that you use the mini VIDAS® analyzer for several days before changing any of
the settings. Later, if you find that you need to change the settings, you can make the
necessary adjustments.
161150-637 - A
7-1
mini VIDAS®
Testing the mini VIDAS® analyzer
Miscellaneous Operations
Testing the mini VIDAS® analyzer
There are a number of simple tests that the mini VIDAS® analyzer can perform.
These tests provide a quick and easy way to verify the display, the keypad, the printer, and the
audio output are working properly.
It is not necessary to perform any of these tests on a routine basis.
All of the hardware tests are found on the Test Menu.
Testing the Display
The mini VIDAS® display screen is composed of several hundred individual points called
pixels.
The display test darkens all the pixels on the display. It begins with the first vertical column on
the left side of the screen, quickly moving towards the right, column by column.
The failure of any pixel to darken can easily be seen.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Functions.
3. Select Test Menu.
4. Select Display Test.
The screen clears initially, and then begins to darken, from left to right, as described
above.
5. When the entire screen has darkened, inspect it for pixels that have failed to darken.
They appear as “holes” in an otherwise dark screen.
6. Press
to return to the Test Menu.
Decrease in the Intensity of Display
The mini VIDAS® analyzer is equipped with a backlight system which improves the display’s
luminosity.
If the intensity decreases considerably or becomes irregular, call bioMérieuxTechnical
Assistance or your local bioMérieux representative.
Note: The intensity of the display does not affect the mini VIDAS® analyzer's ability to perform
operations.
161150-637 - A
7-2
mini VIDAS®
Testing the mini VIDAS® analyzer
Miscellaneous Operations
Testing the Keypad
This test ensures that every key on the keypad is connected to the mini VIDAS® analyzer.
The test requires that you press every key on the keypad.
The mini VIDAS® analyzer responds with a symbol for each key on the display.
The only exception to this pattern is the
key, which activates the help screen.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Functions.
3. Select Test Menu.
4. Select Keypad Test.
The screen clears except for the title:
Keypad Test
5. Press each key on the keypad.
When you are done, the display should be similar to the Keypad Test screen.
Note: The last key pressed ends the test and returns the display to the Test Menu. You will not see
that key’s symbol on the screen.
After the last key is pressed, the following message confirms a passed test:
Keypad okaya
Press any key to continue
Note: If you do not receive this message, contact bioMérieux or your local bioMérieux
representative.
161150-637 - A
7-3
mini VIDAS®
Testing the mini VIDAS® analyzer
Miscellaneous Operations
Testing the Printer
Testing the printer is a matter of sending a string of known characters and ensuring that those
characters are printed.
There are two printer tests: one for an internal and one for an external printer.
Before beginning, make sure that the mini VIDAS® analyzer is connected to the external
printer and that the cord is properly plugged in.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Functions.
3. Select Test Menu.
4. Select Printer Test.
The printer should immediately begin to print the following test pattern.
Note: If the printer does not print the test pattern, the printer is not properly connected.
Testing the audio output
This procedure tests the audio output for the instrument’s alarms.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Functions.
3. Select Test Menu.
4. Select Audio Test.
The mini VIDAS® analyzer should respond with the beep tone.
Note: The display does not change during this test.
161150-637 - A
7-4
mini VIDAS®
Updating an Assay
Miscellaneous Operations
Updating an Assay
When you update an assay, you can use the complete range of VIDAS® reagents by updating
the VIDAS® assay protocols.
IMPORTANT: This function enables you to transfer assay data to the mini VIDAS® analyzer when a
new assay is used or when an existing assay is updated.
IMPORTANT: The update is stored in the mini VIDAS® analyzer for further use of the assays.
CAUTION: If your mini VIDAS® analyzer is connected to an LIS, please contact
your computer service company to check that the new assay version is consistent
with your LIS.
Preliminary Instructions
Before performing the update, make sure that:
•
no assays are running,
•
no reagents (strips and SPRs®) remain in the strip sections and SPR® blocks,
•
printing is not in progress,
•
results have been printed or sent to the LIS, if applicable (see Reprinting an Assay Report
and Validating LIS Results for further information).
•
the bar code reader provided for this update has been installed and configured.
If not, see Appendix - Installing external hardware .
•
the PTC bar codes on the reagent kit package insert must be in good conditions.
To be readable the bar code must be complete, free of stains or tears.
If the bar codes are stained or torn, contact bioMérieux or your local bioMérieux
representative.
Note: If PTC bar codes have to be printed (after downloading them from the bioMérieux technical
library), do not change their size and contrast. Changing size and contrast can affect the
quality of the printed bar code and subsequently, the ability of the bar code to be read by the
bar code reader.
161150-637 - A
7-5
mini VIDAS®
Updating an Assay
Miscellaneous Operations
Reading Assay Update Card Bar codes
1. Select Utility Menu in the Main Menu.
2. Select Assay Update.
3. Select No if the data has to be sent to the LIS or reprinted.
Follow the instructions for sending or printing data before the update (see Reprinting an
Assay Report and Validating LIS Results for further information).
or
Select Yes.
The following message appears:
Please wait...
The assay update card bar code screen is displayed:
1
2
1 — Assay Update: describes the status of the current reading.
2 — Reading instructions: follow these instructions as they appear during the update
procedure.
161150-637 - A
7-6
mini VIDAS®
Updating an Assay
Miscellaneous Operations
To read a bar code:
4. Take the page in the package insert that includes the bar codes (back of the package
insert) or the printed bar codes (downloaded from the technical library).
Figure 7-1: Example of a bar code
5. Read the first bar code using the bar code reader.
Note: Older bar code readers may require that you slowly scan the bar code from top to bottom or
bottom to top until the code has been read completely.
The reader beeps when the reading is finished.
6. Wait for a few moments to allow data to transfer.
The following message is displayed on the screen:
Please wait…
Note: The first reading may take a while as you need to become familiar with the use of the reader.
Continue until reading is successful.
The reading screen is updated.
1
2
1 — Total number of bar codes to be read.
2 — Number of the code already read.
The codes may not necessarily be read in numerical order.
161150-637 - A
7-7
mini VIDAS®
Updating an Assay
Miscellaneous Operations
7. Read the second bar code using the bar code reader.
8. Wait for a few moments to allow transfer of the data.
9. If necessary, repeat the reading and waiting steps until all the codes required to update
the protocol have been read.
Note: The number of bar codes to be read for the update depends on the protocol.
When reading is complete, a summary of the update status is displayed on the screen.
10. Select Confirm to quit to validate the update.
The following message appears:
Please wait...
11. Wait a few moments for the data to be saved.
The Utility Menu is displayed. The update is complete.
12. Press
to return to the Main Menu.
An assay update report is printed.
161150-637 - A
7-8
mini VIDAS®
Displaying the mini VIDAS Software Version
Miscellaneous Operations
Bar code reading may fail if
•
The code was not correctly read by the reader.
•
The code is unreadable (incomplete, stained, or torn).
•
The code read does not belong to the series of codes for the current update. You should
only read codes belonging to the same series.
If bar code reading fails, a warning message is displayed.
1. Solve the problems described in the message.
2. Repeat the bar code reading.
Displaying the mini VIDAS Software Version
1. Select Utility Menu in the Main Menu.
2. Select Misc. Function.
3. Select Version Menu.
4. Select Show Software Version.
The software version screen displays.
5. Press any key on the keypad to return to the Version Menu.
6. Press
to return to the Main Menu.
Printing the mini VIDAS Software Version
1. Select Utility Menu in the Main Menu.
2. Select Misc. Function.
3. Select Version Menu.
4. Select Print Software Version.
The Software version begins to print and the display returns to the Version Menu.
5. Press
161150-637 - A
to return to the Main Menu.
7-9
mini VIDAS®
Displaying the Assay Version
Miscellaneous Operations
Displaying the Assay Version
Use this procedure to display the Assay version for the selected assay.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Function.
3. Select Version Menu.
4. Select Show Assay Version.
An assay selection list appears:
5. Select an assay.
Note: An intermediate screen appears for assays that have more than one version; the version used
is represented in the first two characters of the strip's bar code.
6. Press any key to return to the assay selection list.
7. Repeat this procedure to display additional assays.
or
Press
161150-637 - A
to return to the Main Menu.
7-10
mini VIDAS®
Section Counters
Miscellaneous Operations
Section Counters
1. Select Utility Menu in the Main Menu.
2. Select Misc. Function.
3. Select Section Counters.
4. Select a section.
A screen appears showing the 2 counters.
1
2
3
1 — [C1]: The number of job lists run in this section since the mini VIDAS® analyzer was
installed.
2 — [C2]: The number of job lists run in this section since the last reset performed by a
bioMérieux representative.
3 — Date of the last reset.
IMPORTANT: Only bioMérieux personnel or a qualified person trained by bioMérieux can perform the
reset operation.
Printing the Assay Version
Use this procedure to print the list of assays and their respective versions.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Function.
3. Select Version Menu.
4. Select Print Assay Version.
The following message appears:
Preparing report
Please wait...
The assay list then begins to print and the display returns to the Version Menu.
5. Press
161150-637 - A
to return to the Main Menu.
7-11
mini VIDAS®
Updating the mini VIDAS® Software
Miscellaneous Operations
Updating the mini VIDAS® Software
Updates are sent to you by bioMérieux on memory cards. An update procedure will also be
provided if the mini VIDAS® software needs to be updated by the customer.
IMPORTANT: The update process saves all database contents, including previous protocols data
loaded with updated PTC features. Valid calibrations and controls are not impacted by
the update.
Before performing the update, make sure that:
•
no assays are running,
•
no reagents (strips and SPRs®) remain in the strip sections and SPR® blocks,
•
printing is not in progress,
•
results have been printed or sent to the LIS, if applicable (see Reprinting an Assay Report
and Validating LIS Results for further information).
•
the bar code reader provided for this update has been installed and configured.
If not, see Appendix - Installing external hardware .
To update the mini VIDAS® software:
1. Shut down the mini VIDAS® analyzer (see “Shutting Down the System” on page 4-4).
2. Place the memory card in the slot on the back of the instrument, in the direction indicated
by the arrow, with the label towards the outside.
Figure 7-2: mini VIDAS® analyzer back panel
Note: The memory card is placed in the slot with the end containing the two rows of connector holes
inserted first.
3. Apply gentle pressure on the center of the card to place it.
Note: The eject button, located below the slot, pops up when the card is properly seated. The card
itself is keyed so that it can be placed properly.
4. Switch on the mini VIDAS® analyzer (see “Starting the System” on page 4-3).
5. Follow the instructions of the update procedure provided with the memory card.
161150-637 - A
7-12
mini VIDAS®
Verifying the Memory Card Data
Miscellaneous Operations
Verifying the Memory Card Data
Use this procedure to verify the data on the memory card that is installed in the memory card
slot on the back of the mini VIDAS® analyzer.
1. Select Utility Menu in the Main Menu.
2. Select Card Info.
The following message appears:
Scanning card
Please wait...
After the mini VIDAS® analyzer reads the card, a screen containing the card data
appears.
3. Press any key to return to the Utility Menu.
Parking the mini VIDAS® analyzer
CAUTION: Follow this procedure very carefully to avoid causing any damage to
the extremely fragile electrical components and the optical parts of the instrument.
1. Select Utility Menu in the Main Menu.
2. Select Misc. Functions.
3. Select Park system.
The following message appears:
Parking disables the instrument.
Are you certain?
The prompt is accompanied by [Yes] and [No] selections.
4. Select Yes to park the mini VIDAS® analyzer.
Note: From this point, the parking process cannot be interrupted.
The following occurs:
•
The scan head moves inside the instrument. It is being placed in its parked position.
•
Other parts of the mini VIDAS® analyzer are placed in their parked positions.
•
The two reagent strip trays are retracted into the instrument.
When the mini VIDAS® analyzer is fully parked, the status lights on each section blink.
5. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4).
161150-637 - A
7-13
mini VIDAS®
8
Maintenance
Maintenance of the mini VIDAS® analyzer comprises:
•
the preventive maintenance operations performed by bioMérieux technicians or a qualified
person trained by bioMérieux,
•
the routine maintenance operations which should be performed by the user.
Preventive Maintenance
IMPORTANT: Optimum performance of the mini VIDAS® analyzer (within the limits of bioMérieux
specifications) depends on the preventive maintenance being performed by bioMérieux
technicians or a qualified person trained by bioMérieux only, as part of a maintenance
contract.
For servicing information, contact bioMérieux or your local distributor (contact information
available on www.biomerieux.com).
User Maintenance
Required Tools
The basic equipment and products required are:
•
Disposable powderless gloves (latex-type)
•
Dacron® swabs (Part no. 30531)
•
Cleaning & disinfection wipes
•
Laboratory cleaning and disinfection solution
•
Quality Control VIDAS® (QCV) pipette mechanism test (Part no. 30706).
•
VIDAS® Lens Cleaner (Part no. 93567)
WARNING
Cleaning and disinfection solution and wipes should be provided by
your local suppliers. 
The cleaning and disinfection solution can be identical to the one used
in the wipes (same active principle).
Solutions concentrations must be LOWER than or EQUAL to:
161150-637 - A
•
70% for ethanol
•
70% for isopropanol
•
0.05 M for NaOH
8-1
mini VIDAS®
User Maintenance
Maintenance
Cleaning and Disinfection Procedures
Cleaning and disinfection involve:
•
Routine cleaning which should be performed on a periodic basis.
•
Cleaning of accidental spills (accidental contamination), which should be dealt with
immediately.
CAUTION: Turn the mini VIDAS® analyzer power switch to OFF and then
disconnect the power cord (see Starting the System on page 4-3).

This operation must be performed once all assays are completed.

Use powderless disposable gloves.

Do not allow disinfectant solution to spill into the instrument.
CAUTION: It is the responsibility of the user to clean and disinfect the mini
VIDAS® analyzer.

The instrument must always be thoroughly cleaned and disinfected before
servicing by a bioMérieux Service Engineer.

Complete decontamination of the instrument involves all cleaning tasks
described in the Maintenance Schedule.
161150-637 - A
8-2
mini VIDAS®
User Maintenance
Maintenance
Cleaning the SPR® block (Monthly)
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4).
2. Open the SPR® block door slightly.
3. Tilt the safety latch located on the left side and then fully open the SPR® block door.
Note: Previous versions of the mini VIDAS® analyzer have no safety latch. For these versions, you
can directly open the SPR® block door
161150-637 - A
8-3
mini VIDAS®
User Maintenance
Maintenance
4. Using a Dacron® swab moistened with a laboratory cleaning and disinfection solution,
carefully clean the interior of each SPR® liner of the first SPR® block.
5. Continue the operation by using a new Dacron® swab moistened with the cleaning and
disinfection solution for each SPR® block.
Note: Laboratory cleaning and disinfection solution can be identical to the one used in the wipes
(same active principle).
IMPORTANT: The presence of fibers from the Dacron® swab inside the SPR® liners may interfere with
the performance of the mini VIDAS® analyzer.
When cleaning the SPR® liners, replace any swab if it becomes fluffy.
161150-637 - A
8-4
mini VIDAS®
User Maintenance
Maintenance
6. Clean all surfaces of the SPR® block by using the cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
CAUTION: Do not clean the seals situated above the SPR® block as they only
require cleaning when preventive maintenance is performed by the bioMérieux
Field Service Engineer.
In the event of accidental spills or contamination, it is imperative that you contact
bioMérieux or your bioMérieux representative.
Handling of the seals may affect the performance of your instrument.
161150-637 - A
8-5
mini VIDAS®
User Maintenance
Maintenance
7. Press each SPR® liner until you are able to clean its rear end.
8. Repeat this procedure for each SPR® liner of each block.
9. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
161150-637 - A
8-6
mini VIDAS®
User Maintenance
Maintenance
Cleaning the Reagent Strip Trays (Every 6 Months or if Needed)
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Open the section tray dust cover (Plexiglas).
3. Clean the strip slots with the cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
4. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
161150-637 - A
8-7
mini VIDAS®
User Maintenance
Maintenance
Cleaning the Plastic Trays (Every 6 Months or if Needed)
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Open the section tray dust cover (Plexiglas).
3. Move the strip tray in order to have access to the plastic tray.
4. Clean the plastic tray with cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
5. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
The strip tray will move back into place automatically.
161150-637 - A
8-8
mini VIDAS®
User Maintenance
Maintenance
Cleaning the Strip Preparation Trays (Every 6 Months or if Needed)
Note: Previous versions of the mini VIDAS® analyzer may not have a strip preparation tray.
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Open the strip preparation bay.
.
3. Clean the strip preparation tray with cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
4. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
161150-637 - A
8-9
mini VIDAS®
User Maintenance
Maintenance
Cleaning the Outer Covers of the Instrument (Every 6 Months or if Needed)
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Wipe all surfaces with cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
3. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
Cleaning the Screen and Keypad (Every 6 Months or if Needed)
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Wipe the screen and the keypad with cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
3. If no other maintenance tasks have to be performed, start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
Cleaning the Bar Code Reader (Every 6 Months or if Needed)
1. Wipe the bar code reader (except the window) with cleaning and disinfection wipes.
Note: Wipe all surfaces thoroughly with the wipe, ensure complete wetting and allow to take effect.
2. Clean the reader window with a soft cloth.
161150-637 - A
8-10
mini VIDAS®
User Maintenance
Maintenance
Cleaning Optical Lenses (Monthly)
It is recommended to perform the following procedure to ensure the cleanliness of the scanner
and prevent optical self-test errors and self-calibration drifts.
IMPORTANT: The VIDAS® Lens Cleaner is intended for cleaning the optical lenses of the mini VIDAS®
analyzers.
•
Turn the power switch to OFF before cleaning the optical lenses.
•
Before each use: Take the VIDAS® Lens Cleaner out of its package and squeeze the
rubber ball hard two or three times in order to remove any moisture inside.
•
During cleaning: Avoid touching the lenses with the extremity of the tool as it could
damage them.
•
After each use: Put the VIDAS® Lens Cleaner back into its package and store it in a
dry place.
•
In case of accidental spills on the VIDAS® Lens Cleaner, clean the tool with a dry
clean cloth.
•
If any substance is accidentally introduced inside the VIDAS® Lens Cleaner, replace
the tool.
1. Open the SPR® block doors of sections A and B.
The Scanner head should be visible (see figures below) either in section A or section B.
There are two scanner head models (see Figure 8-1).
Model A
Model B
Figure 8-1: Scanner models
2. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
161150-637 - A
8-11
mini VIDAS®
User Maintenance
Maintenance
3. Position the VIDAS® Lens Cleaner above the lens.
4. Clean the upper lens (tilted surface): squeeze the rubber ball hard ten times.
Model A
Model B
Figure 8-2: Cleaning the upper lens
5. Clean the lower lens (horizontal surface) by squeezing the rubber ball ten times.
Model A
Model B
Figure 8-3: Cleaning the lower lens.
6. Close the SPR® block doors.
7. Start the mini VIDAS® analyzer (see Starting the System on page 4-3).
Checking the Pipetting System (Monthly)
CAUTION: Quality Control VIDAS® (QCV) must be run on all the mini VIDAS®
analyzer positions at least once a month or anytime that a pipetting problem is
suspected.
The Quality Control VIDAS® (QCV) allows to check pipette mechanisms of the section pumps.
Follow the instructions in the VIDAS® QCV package insert.
To analyze the results, refer to the «Results interpretation» section in the VIDAS® QCV
package insert.
161150-637 - A
8-12
mini VIDAS®
Calibration and Adjustments
Maintenance
Calibration and Adjustments
Optical System
The mini VIDAS® analyzer optical system measures the concentration of the reaction product
developed during an assay with a single channel fluorometer.
This optical system uses a dual beam excitation system to compensate for variations in the
lamp output.
The optical system can be moved across the instrument to read the desired test position. The
reagent then produces a fluorescence signal proportional to its concentration.
Manual Optics Calibration
Instrument calibration is provided using a standard calibration solution in a VIDAS® strip
prepared by bioMérieux. These calibration strips are checked by QC/QA and values are
assigned to the strip [approximately a 3,200 RFU reading with an 8,000 nM solution of 4methylumbelliferone (4-MU) in a buffer.
Instrument calibration should be checked every 12 months by bioMérieux Technical
Assistance.
Self Diagnostics
Internal self diagnostics of the optics include computations that monitor the CVs of the
readings and will issue warning messages if wide ranges of data within the readings of a
cuvette is detected.
The computer also periodically takes readings on the surrounding environment and issues a
message if the air readings fall out of expected bounds.
Self-calibration
To further verify the performance of the optical system, the mini VIDAS® analyzer also uses
the optical reference to detect instrument problems before they have an opportunity to impact
the results of an assay.
The mini VIDAS® analyzer incorporates a fluorescent europium material embedded in an
optically transparent polymer as a fluorescence optical reference.
This reference allows the mini VIDAS® analyzer to monitor the condition of the entire optical
system for changes that could result in optical drift.
The long life reference material is placed in a standard VIDAS® cuvette mounted internal to
the instrument and placed between bays A and B.
The optical system periodically measures the reference and the results are closely monitored
by the mini VIDAS® analyzer to insure there is minimal optical drift between calibrations.
161150-637 - A
8-13
mini VIDAS®
Calibration and Adjustments
Maintenance
The instrument is calibrated at the appropriate service intervals by the service technician using
a standardized solution of 4 MU in a buffer. Once the instrument is properly calibrated, the
technician instructs the mini VIDAS® analyzer to measure the built-in reference standard.
The value of this reading is stored by the mini VIDAS® analyzer and becomes a reference
point for future calibration checks.The internal reference is recalibrated every time the
instrument is recalibrated.
In normal operation, the mini VIDAS® analyzer periodically measures the reference during an
idle period and compares the result to the one stored when the instrument was calibrated.
161150-637 - A
•
If the result is outside of the internal adjustment range, the mini VIDAS® analyzer
automaticaily readjusts the optical system to bring the result back within the expected
range.
Moderate drift in the optical system is detected and reported in an error message (error
160).
Unless the error occurs while your analytical module is warming up, clean the optical
lenses (see Cleaning Optical Lenses (Monthly) on page 8-11).
If the problem persists, contact bioMérieux or your local bioMérieux representative.
•
If calibration from one reference check to the next is more than ± 3%, a warning message
is issued to alert the operator to the calibration adjustment and to contact bioMérieux or
your local bioMérieux representative.
Significant optical drift since the last calibration is detected and reported as an instrument
error.
8-14
mini VIDAS®
Calibration and Adjustments
Maintenance
Pipetting System
The mini VIDAS® analyzer handles reagents via two six-pipettor channels (1 per section),
which carry out all reagent transfers, dilution and washing by means of the SPRs®.
The pipettors can accommodate liquid volumes. The entire module can move up and down,
allowing the SPRs® to access wells in the reagent strip. The six pipettor channels are
physically independent, but mechanically linked to act in unison.
Fluids move in and out of each SPR® channel by using an air displacement piston.
Pipetting volume and the speed at which fluids are moved into or out of the SPR® are
microprocessor controlled and programmable via protocol commands. A linear stepper motor
is used to product the precise linear motion required by the module.
Calibration and self diagnostics
The volume accuracy of the fluid displacement is controlled by precision machining of the
critical geometries in the pipettor at the time of manufacture. Field calibration of the pipettor
assembly is not required. Manufacturing verification of pump accuracy is done prior to
shipment.
When running an assay, optical sensors and the microprocessor monitor the linear motion in
the pipetting system. If a deviation in the expected linear displacement occurs, the assay is
automatically stopped and an error message is issued via the computer to the operator.
Field checks of the pipettor accuracy may be accomplished by using bioMérieux controls.
SeeChecking the Pipetting System (Monthly) on page 8-12.
Temperature Validation
The temperature of each tray and SPR® block in the mini VIDAS® analyzer is independently
controlled and monitored.
Each tray and SPR® block contains a highly accurate and stable temperature sensing device
called a thermistor. The thermistors used in the mini VIDAS® analyzer are 0.2°C accurate.
Self diagnostics
The software controlling the instrument runs an algorithm which measures the temperature at
each thermistor every 60 seconds.
This algorithm checks these temperatures and verifies the temperature across all SPR®
blocks within an instrument as well as the temperature across all trays within the instrument.
In addition to these consistency measurements, an absolute measurement comparison is
made to insure that the temperature at any thermistor is also within specified range.
If any of these checks fails, the instrument will report an error to the user and the assay being
run on this section will be aborted. No other assays can be run until the condition is resolved.
161150-637 - A
8-15
mini VIDAS®
Calibration and Adjustments
Maintenance
Master Curve Establishment and Calibration
Establishing the master curve (performed at the manufacturer)
The master curve is established at the time of manufacture for each lot of reagents. It
establishes the mathematical relationship of RFV versus concentration and is provided with
each kit.
Well defined reference solutions (standards) are used to make this determination.
Each assay is associated with a particular mathematical model based on the fundamental
properties of that assay.
To determine the master curve, the standards/calibrators are tested in seven different runs on
the same mini VIDAS® analyzer.
The mean curve of these seven runs becomes the master curve. Four points from the master
curve, which uniquely and completely specify the curve, become the master curve data. These
data are specific for a certain manufacturing lot and are encoded in bar codes (Master Lot
Data) provided with each kit.
Establishing the Calibration Curve (performed by the customer)
The customer defines a curve specific to a particular mini VIDAS® analyzer by recalibrating
the master curve using the standard/calibrator provided in the kit.
Each laboratory must establish its own Calibration Curve.
This function is called recalibration and is based on the mathematical master curve data and
the test results of one or two standards/calibrators tested in duplicate or triplicate by the
customer.
Recalibration serves to control for minor variations in assay signal from one mini VIDAS®
analyzer to another and is therefore specific for each instrument.
On receipt of a new lot of reagents, the customer must enter the master curve data. It may be
entered by a bar code scanner or manual entry of the codes. The customer runs the
standard(s)/calibrator(s) in duplicate or triplicate to define the instrument-specific calibration
curve.
The calibration curve is valid for an extended period of time specified for each assay (14 or 28
days, depending on the type of assay). After this time, the software requires another
calibration.
This recalibration over time accommodates minor variations in assay signal throughout the
shelf-life of the kit.
The calibration curve is valid for analyte concentrations between zero and the standard/
calibrator (from the master curve data) with the highest concentration.
If the RFV is higher or lower (depending on the type of assay) than the signal of this highest
standard/calibrator, the message "greater than the concentration of (assay dependent
standard)" is given.
161150-637 - A
8-16
mini VIDAS®
A
Appendix - Maintenance Records
Maintenance Schedule
Part
Frequency
Procedure
SPR® block
Monthly
Cleaning the SPR® block (Monthly)
Reagent strip tray
Every 6 months or if needed
Cleaning the Strip Preparation Trays (Every
6 Months or if Needed)
Plastic tray (underneath the
Every 6 months or if needed
Cleaning the Plastic Trays (Every 6 Months
or if Needed)
Strip preparation tray
Every 6 months or if needed
Cleaning the Strip Preparation Trays (Every
6 Months or if Needed)
Outer covers
Every 6 months or if needed
Cleaning the Outer Covers of the Instrument
(Every 6 Months or if Needed)
Screen and keypad
Every 6 months or if needed
Cleaning the Screen and Keypad (Every 6
Months or if Needed)
Bar code reader
Every 6 months or if needed
Cleaning the Bar Code Reader (Every 6
Months or if Needed)
Optical lenses
Monthly
Cleaning Optical Lenses (Monthly)
Pipetting device
Monthly
Checking the Pipetting System (Monthly)
reagent strip tray)
161150-637 - A
A-1
mini VIDAS®
Maintenance Check-List
Appendix - Maintenance Records
Maintenance Check-List
YEAR:
Month
1
2
3
4
5
6
7
8
9
10
11
12
Frequency
M
6M/N
6M/N
6M/N
6M/N
161150-637 - A
A-2
mini VIDAS®
Maintenance Check-List
Appendix - Maintenance Records
Month
1
2
3
4
5
6
7
8
9
10
11
12
6M/N
6M/N
Cleaning Optical lenses
(using VIDAS® Lens Cleaner)
M
Checking the Pipetting System
(using VIDAS® QCV)
M
Frequency
M = Monthly
6M = Every 6 months
Keep the preventive maintenance charts.
Complete with your initials
161150-637 - A
N = if needed
A-3
mini VIDAS®
B
Appendix - Troubleshooting
Indication Of Errors
The mini VIDAS® analyzer has several ways to indicate errors: an alarm (a beep) and an
optional visual cue (the display blinks).
Both can be configured.
•
Error beep.
You can set the volume of the beep the mini VIDAS® analyzer emits when there is an
error. There are configuration options to set an initial volume and a final volume.
The initial volume is the volume used when the beep begins.
The volume then increases until you respond, or until it reaches the final volume.
Both volumes can be set to the same level so that there is no increase in loudness.
•
Blinking display.
There is a configuration option in which you can enable or disable a display blink to
accompany the error beep.
See System Installation and Configuration in Chapter 4 for procedures to set these
configuration options.
Displaying Errors
When the mini VIDAS® analyzer alerts you to the presence of an error condition,
1. Press
to respond.
This stops the beeping and blinking display.
Whatever was being displayed when you pressed
screen.
is replaced by an error message
The format of the message screen depends on the type of error.
There are two basic types of error message screens.
161150-637 - A
•
Start error message screen: a start error occurs during the initial processing of a run of
reagent strips.
•
Other type of error message screens: it consists of an error code number and the error
message itself.
B-1
mini VIDAS®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Error Messages and Recovery Procedures
This section lists the possible error messages and general problems that could occur when
using the system.
Start Errors
A start error can occur when you start a section during the verification phase.
The mini VIDAS® analyzer reads the bar code on the label of each reagent strip and performs
an optical check of the substrate. If one of these checks fails, a start error message will
appear.
Depending on the selections you made in the Configuration Menu:
•
The mini VIDAS® analyzer beeps.
•
The display blinks.
•
The error message is printed.
Start errors cause the mini VIDAS® analyzer to stop the run in the section containing the
error. The other section is not affected by any of this action.
1. Press
to display the error message screen.
An error screen appears.
The screen displays the status of each position in the section that has the error.
2. Solve the anomalies if needed (See the Problem Resolution table on page B-3).
3. Press
from the error message screen.
The following selections are displayed:
Restart
Cancel
161150-637 - A
B-2
mini VIDAS®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
4. Select Cancel to abort the run.
or
5. Select Restart to restart the run.
Note: If you select Cancel, the mini VIDAS® analyzer returns to the state it was in before the run
was started.
Any data you entered about the assays are retained.
If you select Cancel, the run resets and begins with another bar code reading and substrate
check.
Table B-1: Problem Resolution
Error Message / Problem
Cause
Resolution
Bad Barcode
The mini VIDAS® analyzer was unable to
read the bar code on the reagent strip.
1. Enter the strip bar code manually. See
Manually Entering Bar codes on
page B-5.
Expired lot
The VIDAS® reagent lot has expired.
If you run the assay, a message will
appear on your result sheet indicating
that the assay was performed using an
expired lot.
1. Use a new reagent kit.
The assay in this position is not
compatible with other assays in the
section.
This type of error should only occur in a
Load and Go run.
In a defined run, the mini VIDAS®
analyzer would detect incompatible
assays before they were run.
1. Run the reagent strip in the other
section or in a different run.
2. Check for assay compatibility (see
Checking Assay Compatibility on
page 5-2).
Misaligned
A dual reagent strip has been placed in
the wrong positions.
This type of error should only occur in a
Load and Go run.
In a defined run, the mini VIDAS®
analyzer would detect a misaligned dual
reagent strip.
1. Move the strip so that it occupies an
acceptable pair of positions: 1 & 2, 3 &
4, 5 & 6.
Sub.(XX)
The initial substrate fluorescence reading
is not acceptable.
XX corresponds to the fluorescence value
read.
1. Make sure the optical cuvette on the
reagent strip is clean.
2. Change the reagent strip and start
again.
Wrong type
The type of assay specified for this
position is different to the one found by
the mini VIDAS® analyzer.
This type of error should only occur in a
defined run.
1. Put the reagent strips in their proper
positions or correct the test entries.
No strip
An assay was specified for this position
but no reagent strip was found.
This type of error should only occur in a
defined run.
1. Place a reagent strip in the appropriate
position or delete the entry for that
position.
Incompatible
161150-637 - A
B-3
mini VIDAS®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Table B-1: Problem Resolution
Error Message / Problem
Cause
Resolution
Unknown Assay
There is no protocol stored in the mini
VIDAS® analyzer for the assay type.
This type of error should only occur in a
Load and Go run.
1. Stop and update the PTC of the assay
of the corresponding position.
Not Empty
The position is supposed to be empty, yet
a test is detected.
1. Remove the reagent strip.
Missing ID
The sample ID, required for configuration
of the LIS, is missing.
1. Stop and return to the section status
screen to enter an ID for the position.
Wrong Control
Wrong Std
The number of the control or standard
has been entered for a parameter
whereas it does not exist in the PTC
base.
1. Stop and return to the section status to
check controls or standards/calibrators
for the position.
No Standard
There is no calibration in the mini
VIDAS® analyzer and no standards/
calibrators in the job list.
1. Stop and return to the section status
screen to enter standards/calibrators
for the position.
Old Standard
The calibration for this assay lot has
expired.
1. Stop and return to the section status
screen to run a new calibration for the
position.
No Master Lot
The Master Lot Data were not entered.
1. Stop and enter the Master Lot Data for
the assay of the corresponding
position.
Select Assay
This type of error should only occur in a
Load and Go run when the same strip
can be used for different assays (eg.:
VIDAS® LYG and VIDAS®LYGS).
1. Stop and return to the section status
screen to select the assay you want to
run.
161150-637 - A
B-4
mini VIDAS®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
Manually Entering Bar codes
This procedure begins from the error message screen display.
1. Press the <Number Key> for the position containing the bar code error.
2. Remove the reagent strip from the section and find the eight-digit alphanumeric bar code,
located next to the assay code.
3. Manually enter the bar code as follows:
a. Press the appropriate <Number Key> to enter a digit.
b. For a letter, press the arrow keys to highlight the appropriate character in the
character box.
c.
Select the [character box].
It appears in the cursor box.
Note: "O" and "I" are letters.
"Ø" and "1" are the digits zero and one.
When the bar code entry has been completed,
4. Press
.
The mini VIDAS® analyzer checks the bar code you entered.
• If the bar code is valid, the display returns to the Error message screen.
• If the bar code is not valid, the following message appears:
Warning: Barcode still invalid
Press any key to continue
5. Press any key on the keypad.
The display returns to the error message screen.
161150-637 - A
B-5
mini VIDAS®
Error Messages and Recovery Procedures
Appendix - Troubleshooting
6. Start the procedure from the start if you want to reenter the bar code.
or
Press
If you press
.
, the following selections appear:
Restart
Cancel
7. Select Cancel to abort the run.
or
Select Restart to restart the run.
Note: If you select Cancel, the mini VIDAS® analyzer returns to the state it was in before the run
was started.
Any data you entered about the assays are retained.
If you select Restart, the run resets and begins with another bar code reading and substrate
check.
161150-637 - A
B-6
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Other Error Messages
When the mini VIDAS® analyzer detects a System error, an error message screen is
displayed.
System errors cause the mini VIDAS® analyzer to halt the run in the section containing the
error. The other section is not affected by any of this action.
These error alert cues continue until you respond to the error condition by pressing the <?>
key.
This action causes the mini VIDAS® analyzer to display an error message screen. The text on
the screen is similar to the following:
Errorcode: 73
Time: 14:53:20 14/09/15
MLE Card data bad
Instrument Errors
Instrument errors can occur for a broad range of error conditions.
An error message display consists of three lines: the error code, the time, and the error
message. For example:
161150-637 - A
•
Errorcode: 73
This line contains a number that corresponds to the specific error. Make note of this
number in case you need to contact the bioMérieux Technical Assistance.
The mini VIDAS® analyzer maintains a log of the last ten error messages produced by the
mini VIDAS. They are saved unless THE mini VIDAS® analyzer power is shut off.
You can access stored error messages via the View Saved Errors function.
•
Time: 14:53:20 14/09/15
This line contains the time and date that the error message was produced.
•
MLE Card data bad
This line contains the actual error message text. These messages are detailed in the Error
Messages section.
B-7
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Error Messages
Listed below are all of the error messages programmed into the mini VIDAS® analyzer.
•
If error messages other than the ones below appear, call bioMérieux Technical Assistance
or your local bioMérieux representative.
•
In some cases, there are suggestions for corrective action. Where no corrective action is
possible, or if the corrective actions fail, the final action is to call bioMérieux Technical
Assistance or your local bioMérieux representative.
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
Warning - LIS
Validation Queue Full
The validation queue is a temporary
storage area for results waiting to be
validated.
This message appears if the results of 8
sections are already stored in the
validation queue and a 9th section is run.
1. Use the results validation procedure to
remove results from this queue (see
Validating LIS Results on page 6-9).
Warning
LIS
queue full
upload This message indicates a possible
®
problem in the mini VIDAS analyzer to
LIS interface.
1. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message.
Some scanner errors This message may occur after repeated
scanner errors.
lost due to overflow
1. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message.
Some section errors This message may occur after repeated
scanner errors.
lost due to overflow
1. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message.
Optics
autocalibration data
corrupt - instrument
may
be
out
of
calibration
1. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message.
Configuration
not found
MLE Card data bad
data This error would occur during the poweron startup sequence.
Note that any previously entered
configuration options are lost, and the
options have returned to their default
states.
The instrument failed to read a Master
Lot Entry (MLE) card (for assays using a
MLE card).
1. Enter one or two configuration
changes.
2. Repeat the power up start sequence.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Inspect the card for proper placement
in the reagent strip tray, debris, or
smudges.
2. Replace or reinsert, as necessary.
3. Retry the read operation, or enter the
data manually.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
161150-637 - A
B-8
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Assay
failed
data
Cause
Resolution
load The mini VIDAS® analyzer cannot read
the protocol memory card.
1. Make sure the protocol memory card is
in the memory card slot.
2. Reinsert the memory card to ensure
proper contact.
3. Retry the last operation.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Normal
failed
Range
save
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Normal
failed
Range
load
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Assay startup error
This error would appear during the
preprocessing steps of a run.
1. Perform the procedure to halt the
section.
2. Retry an assay in the same section.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Check the section for physical
obstructions or any jams.
Section reset failed
2. Perform the halt operation on the
section.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Standard save failed
The assays in a section have failed to
process correctly.
1. Retry an assay in the same section.
processing The assays in a section have failed to
1. Retry an assay in the same section.
Assay failed
Assay
error
process correctly
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Retry the operation that created the
error.
Communications error
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Halt the Section with the error. Retry
an assay in the same section.
Section
communications error
161150-637 - A
2. If the error recurs, place the Section
offline and call bioMérieux Technical
Assistance or your local bioMérieux
representative.
B-9
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
Unknown section error
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Unknown
error
software
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Unknown scanner error
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
External
error
printer The external printer has sent an error
1. Consult your printer manual.
Internal
error
printer
1. Retry a print operation.
signal to the mini VIDAS® analyzer
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Check to see that the door to the
SPR® block is completely closed and
restart the assay.
Cannot begin bar code
read - check door
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Check to see that the door to the
SPR® block is completely closed and
restart the assay.
Cannot begin assay check door
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Unable to initialize
Section
This error would occur during the poweron startup sequence.
1. Shut down the mini VIDAS® analyzer
(see Shutting Down the System on
page 4-4.)
2. Check the instrument for physical
obstructions or other possible jams.
3. Start the mini VIDAS® analyzer again
(see Starting the System on page 4-3).
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
External printer
offline
The external printer has sent an offline
signal to the mini VIDAS® analyzer.
1. Press the online button on the printer,
or consult your printer manual.
1. Allow the mini VIDAS® analyzer to sit
idle (not performing assays) for at least
two hours.
Instrument has been
too busy for
autocalibration to
occur
2. Continue normal operations.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
161150-637 - A
B-10
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
New LIS Results have
been discarded due to
full queues
This message appears after other
messages warning you that the LIS result
validation or upload queues are full.
1. Use the results validation procedure to
remove results from this queue (see
Validating LIS Results on page 6-9).
Boot EPROM obsolete
This error would appear during the
power-on startup sequence
1. Shut down the mini VIDAS® analyzer
and then restart it (see Shutting Down
the System on page 4-4 and Starting
the System on page 4-3).
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Scanner board memory
almost full
1. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message.
Scan head motor
movement becoming
restricted
1. Shut down the mini VIDAS® analyzer
(see Shutting Down the System on
page 4-4).
2. Check for any physical obstructions
that could cause a jam.
3. Call bioMérieux Technical Assistance
or your local bioMérieux representative
to report this message
1. Shut down the mini VIDAS® analyzer
and then restart it (see Shutting Down
the System on page 4-4 and Starting
the System on page 4-3).
Scanner Board failure
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Allow any assays that are running to
complete.
Temperature
monitoring failed
2. Shut down the mini VIDAS® analyzer
and then restart it (see Shutting Down
the System on page 4-4 and Starting
the System on page 4-3).
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Shut down the mini VIDAS® analyzer
and then restart it (see Shutting Down
the System on page 4-4 and Starting
the System on page 4-3).
Section hardware
failure
2. If the error recurs, halt the section,
place it offline, and then call
bioMérieux Technical Assistance or
your local bioMérieux representative.
161150-637 - A
B-11
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
1. Shut down the mini VIDAS® analyzer
(see Shutting Down the System on
page 4-4).
Scan head motor
failure
2. Check for any physical obstructions
that could cause a jam.
3. Start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Software failure
1. Call bioMérieux Technical Assistance
or your local bioMérieux
representative.
Tray mechanism
failure
1. Check the reagent strip tray area for
any physical obstructions that could
cause a jam.
2. Also check the tray to see that it is on
its track. This is especially important
after decontaminating the instrument.
3. Run a TP6 assay.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Check the area inside the SPR® block
for any physical obstructions that could
cause a jam.
Pump mechanism
failure
2. Run a TP4 assay.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Check the area inside the SPR® block
for any physical obstructions that could
cause a jam.
Tower mechanism
failure
2. Run a TP5 assay.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
1. Shut down the mini VIDAS® analyzer
and then restart it (see Shutting Down
the System on page 4-4 and Starting
the System on page 4-3).
Hardware failure
2. Retry another assay.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
161150-637 - A
B-12
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
1. Shut down the mini VIDAS® analyzer
(see Shutting Down the System on
page 4-4).
Optical hardware
failure (or excessive
auto-calibration
drift)
2. Clean the optical lenses (see Cleaning
Optical Lenses (Monthly) on page 811).
3. Start the mini VIDAS® analyzer (see
Starting the System on page 4-3).
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
No Master Lots
available
The mini VIDAS® analyzer cannot read
the protocol memory card.
1. Make sure the protocol memory card is
in the memory card slot.
2. Reinsert the memory card to ensure
proper contact.
3. Retry the last operation.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
External printer
paper empty
The external printer has sent a signal to
the mini VIDAS® analyzer indicating it is
out of paper
1. Reload the printer with paper.
2. If the printer still has paper, check the
cable connections between the printer
and the mini VIDAS® analyzer.
3. Consult your printer manual if
necessary.
1. Install another roll of paper in the
thermal printer.
Internal printer
paper empty
2. Attempt another print operation.
3. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Restoring saved
master lot
information
1. Try to reenter the Master Lot data.
SPR temperature out
of allowed range
1. Check the temperature of the SPR®
block.
2. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
2. If the temperature is low, make sure all
doors on the mini VIDAS® analyzer
are closed.
3. Allow time for the temperature to
equilibrate.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
161150-637 - A
B-13
mini VIDAS®
Other Error Messages
Appendix - Troubleshooting
Table B-2: Problem Resolution
Error Message / Problem
Cause
Resolution
1. Check the temperature of the reagent
strip tray.
Tray temperature out
of allowed range
2. If the temperature is low, make sure all
doors on the mini VIDAS® analyzer
are closed.
3. Allow time for the temperature to
equilibrate.
4. If the error recurs, call bioMérieux
Technical Assistance or your local
bioMérieux representative.
Unable to complete
LIS upload of results
The mini VIDAS® analyzer was unable to
transfer its results.
1. Check all cable connections between
the mini VIDAS® analyzer and the LIS
computer.
2. Make sure that your LIS computer is
ready to receive data.
161150-637 - A
B-14
mini VIDAS®
Problems that May Occur with the Bar code Reader
Appendix - Troubleshooting
Problems that May Occur with the Bar code Reader
The reader does not emit a beam of light
1. Check that the cable is securely connected (see the installation procedure in Appendix Installing external hardware).
2. Check that the trigger is working.
After verification, if the reader does not function properly:
1. Repeat the bar code reader installation procedure.
If the problem persists, call bioMérieux Technical Assistance or your local bioMérieux
representative.
Reader fails to read bar codes
The bar codes are unreadable:
IMPORTANT: To be readable, bar codes must be complete, unstained, and untorn.
1. If the configuration sheet provided with the reader is missing or unreadable, call
bioMérieux Technical Assistance or your local bioMérieux representative.
The reader window is not clean:
1. Check that the reader window is clean and if necessary clean it using a soft cloth.
2. Repeat the reading.
The reading distance is incorrect:
1. Slowly move the reader away from and/or towards the bar code until the optimal position
for reading has been reached.
Note: A beep indicates that reading has been performed.
161150-637 - A
B-15
mini VIDAS®
Assay Report Errors
Appendix - Troubleshooting
Assay Report Errors
Errors related directly to results on an assay report are not displayed on an error screen.
Rather, the assay report itself is used to report these errors.
The assay report uses a set of symbols to mark the part of the report that contains the error. A
footnote then appears at the bottom of the report, referencing the same symbol. The footnote
includes the error message.
Correcting Assay Report Errors
In all cases, the test should be repeated.
If the error recurs and you suspect a problem in the mini VIDAS® analyzer, call bioMérieux
Technical Assistance.
Assay Report Error Symbols
The symbols in Table B-3 are used on assay reports to indicate error messages.
Table B-3: Assay Report Error Symbols
Symbol
Message
Cause
&
Low reading.
A fluorescence reading for the reagent strip is below a
preset limit.
§
High reading.
A fluorescence reading for the reagent strip is above a
preset limit.
¥
Offscale reading.
A fluorescence reading for the reagent strip is outside the
operating range of the detector.
#
Low RFV.
An RFV for the reagent strip is below a preset limit.
!
High RFV.
An RFV for the reagent strip is above a preset limit.
{
No reading.
Call bioMérieux Technical Assistance.

Math Error.
The mini VIDAS® analyzer encountered a calculation error,
e.g., a divide by zero.
@
High Test Value.
A test value calculated for the reagent strip is above a
preset limit.
Low Test Value.
A test value calculated for the reagent strip is below a
preset limit.
¢
Sample Over-Diluted.
~
Low control.»
A high control is giving a low response.
¶
High control.
A low control is giving a high response.
$
Std. CV exceeded.
The coefficient of variation (CV) for the standard result is
greater than a preset limit.
£
Invalid std.
The result for the standard is invalid and cannot be used to
calculate the result for the test samples.
]
Please refer to the package insert
161150-637 - A
B-16
mini VIDAS®
Printer Errors
Appendix - Troubleshooting
Error Messages on Assay Reports
If a standard is out-of-range or missing (when an assay is started), the following error
message is printed at the bottom of the assay report:
Insufficient standard run or Standard value out of range
The test result should not be taken into account, and it is recommended to repeat calibration
for the test.
Printer Errors
If the internal printer is out of paper or does not respond, the mini VIDAS® analyzer will keep
retrying for 30 seconds and begin beeping.
1. Press
to display the error message screen.
The error message refers to the internal printer.
2. Replace the printer paper if the error indicates that the printer is out of paper.
The following selections are displayed:
Retry Printing
Abort Printing
3. Select Retry Printing to try to print the job at this time,
or
Select Abort Printing to stop printing at this time.
The mini VIDAS® analyzer will try to print this job again if:
161150-637 - A
•
the printer is told to print something else,
•
you use the Select Printer function on the configuration menu.
B-17
mini VIDAS®
Viewing Saved Errors
Appendix - Troubleshooting
Viewing Saved Errors
The mini VIDAS® analyzer stores the last ten error messages it creates.
These messages remain in the mini VIDAS® analyzer unless the power is turned off.
Use the following procedure to access the stored error messages.
1. Select Utility Menu in the Main Menu.
2. Select View Saved Errors in the Utility Menu.
The screen displays an error message similar to the following:
Errorcode: 73 (Saved)
Time: 14:53 09/14/Ø2
MLE Card data bad
Note: The first message shown is the newest message stored in the message file.
3. Press
to display the next message.
or
Press
to return to the Utility Menu.
Displaying and Printing Instrument Temperatures
1. Select Status Screen in the Main Menu.
2. Select Display temperatures.
The Temperatures screen appears displaying the temperature readings for the reagent
strip tray and the SPR® block of both sections.
3. Press
twice to return to the Main Menu,
or
4. Select Print if you want to print a copy of the temperature readings.
The temperature report begins to print and the screen returns to the Main Menu.
5. Wait until the result sheet finishes printing (if one is in progress) before printing the
temperature report.
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mini VIDAS®
C
Appendix - Installing external hardware
External printer
Equipment Required
•
Compatible printer.
For information on the recommended type of printer, contact bioMérieux or your local
bioMérieux representative.
•
PC compatible printer cable with a DB 25-pin connector on one end and a 36-pin
Centronix connector on the other end.
•
Small, flathead screwdriver.
Before Installation
1. Make sure that the mini VIDAS® analyzer has been configured for an external printer.
2. If not, refer to Selecting the Printer on page 4-12.
Installation
1. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.).
2. Set the printer near the mini VIDAS® analyzer within reach of the printer cable and an
appropriate electrical outlet.
3. Locate the Printer Port on the rear of the mini VIDAS® analyzer.
Figure C-1: location of printer port
161150-637 - A
C-1
mini VIDAS®
Installing the Bar code Reader
Appendix - Installing external hardware
4. Insert the DB 25-pin connector of the cable into the printer port.
Make sure it is oriented correctly.
5. With the screwdriver, tighten the connector to the port.
6. Insert the 36-pin Centronix connector of the cable into the port on the printer.
Make sure it is oriented correctly.
7. Load the printer with paper per the manufacturer’s instructions.
8. Turn the printer on.
9. Start the mini VIDAS® analyzer (see Starting the System on page 4-3).
10. Test the external printer (see Testing the Printer on page 7-4).
Possible Error Message
If the message "External printer error" appears:
1. Check that the printer is turned on,.
2. Make sure there is a enough paper.
Installing the Bar code Reader
Equipment Required
The reader is supplied in a kit containing:
•
1 bar code reader,
•
1 cable,
•
1 configuration sheet.
Note: The kit must include the above mentioned components. If any are missing, contact bioMérieux
or your local bioMérieux representative.
Installation
1. Connect the cable to the bar code reader.
2. Make sure that the mini VIDAS® analyzer has been configured to use the correct bar
code reader.
3. Select Barcode Wand in the Configuration Menu.
The following selections appear:
• None (the default setting)
• Barcode Wand
Note: A ⊠ symbol indicates the current setting.
4. Select Barcode Wand.
161150-637 - A
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mini VIDAS®
Installing the Bar code Reader
5. Press
Appendix - Installing external hardware
to return to the Configuration Menu.
6. Shut down the mini VIDAS® analyzer (see Shutting Down the System on page 4-4.)
Caution: Always shut down the mini VIDAS® analyzer before connecting the
external bar code reader.
7. Locate the diagnostic port on the rear of the mini VIDAS® analyzer.
Figure C-2: Location of diagnostic port
8. Connect the bar code reader cable to the diagnostic port.
The port and connector are shaped such that the cable can be successfully inserted in
only one orientation.
9. Start the mini VIDAS® analyzer (see Starting the System on page 4-3).
The bar code wand is now ready to use.
If the mini VIDAS® analyzer was already equipped with a bar code reader, the old reader’s
configurations will be replaced by the default configuration of the new bar code reader.
The bar code reader you have received has already been configured by bioMérieux and takes
into account most of the existing types of bar codes.
If the reader does not retain its configuration,
1. Scan the bar codes on the configuration sheet provided with the bar code reader kit.
If the configuration sheet is missing, contact bioMérieux or your local bioMérieux
representative.
161150-637 - A
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mini VIDAS®
D
Appendix - Computer interface information
Introduction
The mini VIDAS® analyzer is a standalone instrument that does not use a separate computer.
It contains everything to support a unidirectional computer interface.
This interface only allows the mini VIDAS® results to be transmitted (i.e., uploaded) to the
Laboratory Information System (LIS) or other host computer system.
Note: The pn and pi fields (patient name and patient identification) are not transmitted as part of the
upload on a mini VIDAS® analyzer as this information does not exist in the mini
VIDAS®application.
The mini VIDAS® fields that are transmitted include:
•
mtrsl
message type
•
pi
patient ID
•
pn
patient name
•
si
specimen separator
•
ci
sample ID
•
rt
short assay name
•
rn
long assay name
•
ql
qualitative result
•
qn
quantitative result
•
tt
test completion time
•
td
test completion date
•
qd
dilution (optional)
The following results are not uploaded:
•
Strips without a sample ID
•
QCV, OPT, LEAK.
•
Any raw result analysis type assays
•
Controls
•
Standards/Calibrators.
The «Ready-to-send» queue can hold up to 48 sample results.
As mini VIDAS® results are not permanently stored in the instrument, uploads should be
performed on a routine basis.
If attempts to upload results are unsuccessful, once the retry interval and number of retries
have elapsed, an error will be logged.
1. To view this log, select
selection.
161150-637 - A
on the keypad or view saved errors from the Utility Menu
D-1
mini VIDAS®
Configuration Information
Appendix - Computer interface information
Configuration Information
CAUTION: Your unidirectional connection must be configured and brought into
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.
1. Select Configuration Menu in the Main Menu.
2. Select LIS Interface Options.
Table D-1: LIS Interface Options
Option
Communication settings
Minim.
Maxim.
Default
• Baud rate
• 300
• 38400
• 1200
• Parity ( None, Odd, Even, Low,
High )


• None
• Character Size
• 7
• 8
• 8
Timeouts & Limits
Minim.
Maxim.
Default
• Timeout
• 2
• 99
• 3
• Checksum Retry Limit
• 0
• 99
• 3
• Checksum Error Retry Interval
• 0
• 99
• 10
• <ENQ> Retry Limit
• 0
• 99
• 3
• <ENQ> Retry Interval
• 0
• 99
• 10
• InterRecord Delay
• 0
• 99
• 0
• InterMessage Delay
• 0
• 99
• 2
Data Format
• Misc. Format
Alternate Protocol
• STX : <CR><LF>
• ETX : <CR><LF>
• RS :
<CR><LF>
• GS :
<CR><LF>
• ENQ : <CR><LF>
• EOT : <CR><LF>
• Send Dilution
Default
• Time Separator
• . : / - ,
• :
• Date Separator
• . : / - ,
• /
• Field Terminator
• !@#$%^&*()-=+<>/?[]\|{}
• |
Send Text Message
Used to send text message patern
161150-637 - A
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mini VIDAS®
Configuration Information
Appendix - Computer interface information
Example of a mini VIDAS® Upload
161150-637 - A
D-3
mini VIDAS®
E
Appendix - Technical Data and Specifications
(previous versions of mini VIDAS® analyzers)
Technical data and specifications are given for previous versions of the mini VIDAS® analyzer
(analyzer without transparent blue section covers).
Dimensions
Instrument packed
Instrument unpacked
Height (cm)
57
44
Width (cm)
68
54
Depth (cm)
68
53
Instrument packed
Instrument unpacked
46
37
Weight
Weight (kg)
Physical Space Requirements
Value
Height (cm)
65
Width (cm)
120
Depth (cm)
90
The instrument must be placed on a flat surface tilted no more than 5°.
161150-637 - A
E-1
mini VIDAS®
Appendix - Technical Data and Specifications (previous versions of mini VIDAS® analyzers)
Electrical Specifications
Electrical Specifications
The instrument includes an internal bar code reader with a 660 nm LED whose radiation is
Class 1 according to IEC 60825-1. This class does not present a risk.
Specification
Value
Voltage
100 - 240 VAC
200 - 240 VAC
The voltage (100 - 240 VAC or
200 - 240 VAC) is selected using
the power unit at the back of the
instrument)
Consumption
1.5 A at 100 - 120 VAC
0.8 A at 200 - 240 VAC
Frequency
50 - 60 Hz
Power
180 Watts (maximum)
75 Watts (minimum)
Fuse Current
External (power input module):
1.5 AT at 100 - 120 VAC
1.6 AT at 200 - 240 VAC
Approximate Emission of Heat
250 Btu / hr
Power Switch
Location: back of instrument
Type: bipolar (phase + neutral)
Max. leakage of current: < 1mA
75 W
Caution: 

The user must comply with the technical specifications and standards in this
manual to ensure user safety as well as the proper functioning of the instrument.
bioMérieux is in no case liable for any damage that may arise from failure to
comply with these specifications or any operation conducted on the equipment not
in compliance with these mandatory standards.
Moreover, the warranty for this equipment is expressly subject to use of the mini
VIDAS® analyzer in compliance with the procedures and specifications herein.
161150-637 - A
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mini VIDAS®
Environmental Conditions
Appendix - Technical Data and Specifications (previous versions of mini VIDAS® analyzers)
Environmental Conditions
Specification
Value
Type of Installation
For indoor use only
Installation category
II
Pollution degree
2
The mini VIDAS® analyzer meets the environmental safety requirements defined in clause
1.4 of the standard IEC 61010-1.
Temperature
Specification
Value
Operating temperature
15°C to 30°C (room temperature)
Storage temperature
-10°C to 40°C
Note: The average heat emission is approximately 512 BTU - 150 W.
Humidity
Specification
Value
Relative humidity
10% to 80% RH non-condensing
Humidity during storage and transport
(non-condensing within the storage and
transport temperature range)
up to 90%
Altitude
Specification
Value
Maximum altitude
2,000 m
Specification
Value
During an analysis
< 59 dBA
Sound Level
161150-637 - A
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mini VIDAS®
Appendix - Technical Data and Specifications (previous versions of mini VIDAS® analyzers)
Technical features
Technical features
Capacity
•
12 test positions (2 sections with 6 positions in each section).
•
Up to 30 tests/hour depending on the type of assay used (see test duration in the package
insert for each VIDAS® assay).
•
Automatic control by stepper motors.
•
2 pumps; one for each section
•
Mixing, diluting, and transferring of liquids
Motors
Pumping
Temperature control
Absolute Accuracy
•
SPR®: 36°C – 38°C
•
Tray: 35°C – 38°C
Relative Accuracy
•
SPR®: ± 0.7°C between the 2 sections
•
Tray: ±
1°C between the 2 sections
Thermal resistance
161150-637 - A
•
Process: thermal resistance
•
Automatic Control: by thermal probe
E-4
mini VIDAS®
Appendix - Technical Data and Specifications (previous versions of mini VIDAS® analyzers)
Optics
Optics
Specification
Value
Detector
Photodiode fluorimeter
Detection range
40 to 40 000 nmol of 4MU (4-Methyl Umbelliferone)
Automatic checking
Automatic checking every 12 hours of the optic
system against a reference standard (named "solid
standard"); automatic calibration if the difference
with the solid standard is > 0.6 %
Assay Kit Specifications
VIDAS® SPR®
Specification
Value
Length
76 mm
Material
Plastic polymer
Work volume
5 to 350 µl
VIDAS® Single Reagent Strip
External dimensions
Value
Length
157 mm
Width
18 mm
Depth
15 mm
Well
Capacity
Sample Well
960 µl
Reagent Well
960 µl
Substrate Well
530 µl
The strip is sealed by a foil to ensure that no evaporation will occur that may compromise the
reagents.
The substrate well is made of a plastic that meets with the appropriate optical qualities.
161150-637 - A
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mini VIDAS®
F
Appendix - Glossary
Assay
A complete test procedure using immunological methods and fluorescent chemistry to detect
or quantify an analyte.
Assay analysis
Interpretation of data using sample assay data, standard assay data, and thresholds for data
comparison. These calculations can be different for each type of assay and can interpret the
assay result.
Assay code
A two-, three-, or four-character designation for an assay used in the mini VIDAS® analyzer.
Assays are defined in the mini VIDAS® analyzer, for example, using the assay code.
Assay Compatibility
The property that two or more assay types have when they utilize the same protocol in the
mini VIDAS® analyzer.
Assay kit
A package containing a set of reagent strips, SPRs®, and a package insert along with any
necessary controls, standards, and sample treatment reagents.
Background
The native fluorescence that a substrate has without the intended chemical reaction for the
assay.
Bar code
A series of lines printed on the label of a reagent strip. The encoded information can be read
and interpreted by the scanner and used to identify the strip.
Calibration
The process of adjusting the standard curve of a quantitative assay lot or storing the
calibrator's RFV for a qualitative assay.
Calibration curve
A set of data, supplied by bioMérieux with each lot of a quantitative assay, that becomes the
standard curve for that lot.
Cuvette
The last of the 10 wells of the reagent strip. It is made of optically clear plastic that permits the
scanner to take an accurate fluorometric reading of the substrate.
Defined run
An assay run in which assay types, sample IDs, standards, and controls are defined on the
mini VIDAS® analyzer prior to the start of the run.
161150-637 - A
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mini VIDAS®
Appendix - Glossary
Dual reagent strip
A strip consisting of a jointly attached sample reference reagent strip (left) and a sample test
reagent strip (right).
Equivocal
An assay analysis result that is neither positive/reactive nor negative/nonreactive; it falls
between the high and low threshold values for the test.
Fluorescence
A physical process in which a substance, after exposure to light at a specific wavelength,
emits light at another wavelength. This is the process used for analyte detection in the mini
VIDAS® analyzer.
Fluorescent units
A numerical value that represents the intensity of fluorescence detected by the optical
scanner.
Load and Go run
An assay run in which reagent strips are placed into the mini VIDAS® analyzer and run
without any prior definition on the mini VIDAS® analyzer.
Master Lot Data
A set of data, supplied by bioMérieux with each lot of an assay that supplies quality control
ranges and, for quantitative assays, becomes the standard curve for that lot.
Master Lot Entry (MLE) card
It is used to enter master lot data into the mini VIDAS® analyzer. Some reagent kits no longer
contain a MLE card. The master lot data is printed under the form of a bar code on the reagent
kit label.
Optical cuvette
The last of the ten wells of the reagent strip. It is made of optically clear plastic that permits the
scanner to take an accurate fluorometric reading of the substrate.
Optical scanner
A component of the mini VIDAS® analyzer that reads the bar code label and measures the
intensity of fluorescence of the assay.
Port
A cable connection site on the back of the mini VIDAS® analyzer.
Position
The reagent strip and SPR® slots in the mini VIDAS® analyzer where a reagent strip/SPR®
pair can be placed.
161150-637 - A
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mini VIDAS®
Appendix - Glossary
Protocol
A specific sequence of computer-controlled activities (pipetting, mixing, incubating, reading,
etc.) needed to perform an assay. Only assays with identical Protocols can be run in the same
section.
Reagent strip
A polypropylene strip consisting of 10 wells with a foil seal and paper label. 
One well of the strip is for the sample.
The other eight wells contain the various reagents required for the immunoassay. The last well
of the strip is the optical cuvette that contains the substrate.
Reagent strip compartment
A temperature-controlled tray with a plastic cover containing six section channels that hold six
reagent strips or three dual reagent strips.
Reagent strip tray
The temperature-controlled tray within the reagent strip compartment. Also called section tray.
Reference strip
The reagent strip in a dual strip pair that is used to measure the background reading for the
sample.
Relative Fluorescence Value (RFV)
The difference between the final and the initial (background) fluorescent readings of a reagent
strip.
Replicates
The multiple samples of a standard that are run, and of which an average value is calculated.
Result
Interpretation of a quantitative or qualitative test.
Sample
The material being tested.
Scanner
A unit in the mini VIDAS® analyzer that contains the fluorescent detector and the bar code
reader.
Section
A microprocessor-controlled assay processing unit in the mini VIDAS® analyzer. Each
analyzer has two sections. Each section contains an SPR® block with six corresponding
reagent strip channels. An SPR® position and its corresponding reagent strip channel make
one test position.
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mini VIDAS®
Appendix - Glossary
Section channel
A groove in a section tray that holds a reagent strip. Channels are designated one through six.
Each has a corresponding SPR® position in the SPR® compartment.
Section tray
A temperature-controlled plate with six channels to hold six Single reagent strips or three dual
reagent strips. Also called reagent strip tray.
Single reagent strip
See Reagent strip.
Solid Phase Receptacle (SPR®)
A specially designed plastic pipette-shaped device with its inside wall coated with antibody,
antigen, or other treatments that allow capture of a target analyte. Each SPR® has a
corresponding VIDAS® reagent strip.
SPR® block
A temperature-controlled block with receptacles to hold six SPRs®. Each has a position for a
corresponding reagent strip immediately below it in the section. A tilt-down door provides
access to the SPR® block.
Standard/Calibrator
A solution containing a known analyte concentration. The RFV obtained from testing a
Standard is used to calculate concentrations and to interpret samples or controls.
Stored Standard
The test result of a standard, stored as data in the mini VIDAS® analyzer, and used to
calculate results for test samples over a period of time.
Strip preparation tray
Note: Previous versions of the mini VIDAS® analyzer may not have a strip preparation tray.
A tray with 6 positions located under each reagent strip tray. It is used to prepare tests for a
specific section as it can hold either 6 individual strips or the boat included in the reagent kit.
Substrate
A substance in the reagent strip that is broken down enzymatically to create a compound that
fluoresces.
Test
That portion of an assay kit used to process a specimen, control, or standard; consists of a
paired reagent strip and SPR®.
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mini VIDAS®
Appendix - Glossary
Test value
The result calculated using the Relative Fluorescent Value (RFV) of the sample and the
Relative Fluorescent Value of the reference or of the standard, depending upon whether it is a
dual or Single reagent strip, respectively.
Threshold
A numerical value stored in the mini VIDAS® analyzer memory.
It is used to translate the test value to qualitative results such as «Positive», «Negative»,
«Equivocal».
Unique Assay Code (UAC)
The Unique Assay Code corresponds to 2 characters encoding the link between all
information needed for the biological assay.
VIDAS® Lens Cleaner
A tool for cleaning the mini VIDAS® analyzer optical lenses in order to avoid optical drift.
161150-637 - A
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mini VIDAS®
Revision History
This section contains a summary of changes made to each released revision of this manual starting with part
number 161150-637 - A.
Change type categories:
N/A
Not applicable (First publication)
Correction
Correction of documentation anomalies
Technical change
Addition, revision and/or removal of information related to the product
Administrative
Implementation of non-technical changes noticeable to the user
Note: • Minor typographical, grammar, and formatting changes are not included in the revision
history.
• Not all versions may be available in all languages.
Release Date
Part Number Change Type
Change Summary
2016/03
161150-637 - A Administrative
• Improvements to match the bioMérieux templates and style
guides.
• Renewed illustrations
Technical change
• Updated information regarding maximum altitude and
storage temperature (Section 3 > Technical Data and
Specifications)
• Updated information regarding frequency and cleaning and
disinfection mode during user preventive maintenance
(Section 8 > User Maintenance and Appendix A >
Maintenance Schedule).
• Corrected information concerning assay calibration
frequency: 28 days for certain assays (Section 3 > Principles
of calibration / recalibration, Section 5 > Defining the
Standards/calibrators and controls to be used and Section 8
> Master curve establishment and calibration).
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