Biomerieux Mini vidas User manual

BIOMÉRIEUX

MINI VIDAS®

ESSENTIALS

bioMérieux S.A. • 69280 Marcy l’Etoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90

www.biomerieux.com

SYSTEM OVERVIEW

SPR®loading

position

Reagent loading position

(12 positions)

Integrated PC

Integrated Printer

Section

Sample Extrenal

Barcodes reader

HOW TO TURN ON MINI VIDAS?

Switch on the MINI VIDAS®with the power switch located on the back of

the analytical module.

Allow the MINI VIDAS®to warm up for 45 minutes.

During initialization, the optical system automatically calibrates against a standard

which reacts to temperature.

Switch o the MINI VIDAS®.

Wait 1 minute and switch on the system again.

This operation enables the standard value to be memorized after the

temperature has stabilized.

Trick: barcode wand must be plugged when system is OFF.

MENU OVERVIEW

MAIN MENU

Start Section: To start an analysis as soon as SPR®, strips and samples are in position.

Status Screen: To know the status of sections A & B and temperature of SPR®and Strip areas.

Master Lot Menu: To scan the Master Lot data for any new parameter or new assay lot.

Results Menu: Direct access to stored results for validation, print or reprint of assay list.

Utility Menu: Conguration of the instrument (e.g.: unit, date & time, user ID, language,

printer, barcode wand).

TOUCH PAD: KEY FUNCTIONS

To erase a data

entry

To go back to

the previous screen

Press once: it will

display errors

Press twice: to print

out the screen

To move the cursor

on certain screens

To show a 2nd 3rd

screen

The «ENTER» key to

validate data

Document only for Training use. Does not replace the User Manual. Refer to MINI VIDAS®user’s manual for detailed data

HOW TO PERFORM A CALIBRATION?

Read the MLE bar code

Integrate factory data into the instrument

1When using a new lot

Calibrate

Adjustment of the instrument

to the factory data

2When using a new lot

Every 14 or 28 days

Control

Check calibration and ensure that reagent

performance has not been altered

After each calibration

When using a new kit

HOW TO SCAN MLE DATA?

In the MAIN MENU, select the Master Lot Menu.

Select Scan Master Lot.

Scan the MLE barcode on the reagent kit label using the bar code reader :

slowly scan the barcode from top to bottom or from bottom to top until the code has

been read completely.

At the end of the reading,

“Please wait” is displayed.

The MLE card is then

automatically printed.

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HOW TO RUN STANDARDS (S)

AND CONTROLS (C) FOR CALIBRATION?

In the MAIN MENU, select Status Screen.

THEN PRESS

Repeat this operation for each standard and control used for the test.

Load SPR®, Strips and distribute Standard and Controls in the strips.

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2. Select the1st position

Typing 1.

3. Select Sfor the standard,

or C for the control.

4. Type 1 for the standard

number 1…

Run the analysis selecting “START”.

1. Select section Aor B.

Document only for Training use. Does not replace the User Manual. Refer to MINI VIDAS®user’s manual for detailed data

Then start running the samples (using

the protocol below).

2. Type 1.

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3. Select Sample ID. 4. Enter the Sample ID *

and, if necessary, the dilution factor.

1. Select a free section.

THEN PRESS

AFTER IDENTIFYING

THE LAST PATIENT,

PRESS

Sample ID can also be entered by using the barcode wand.

ON THE KEYBOARD TO MOVE THE CURSOR AND SELECT THE

CHARACTERS, THEN VALIDATE THEM ONE BY ONE BY PRESSING.

USE THE ARROW PAD.

Sample identication

(maximum of 12 alphanumeric characters)

Numeric characters are entered using the keyboard.

Alphabetic characters are entered by selecting each character on the screen:

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UNTIL THE WORK LIST

FOR THE SECTION IS

DISPLAYED

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HOW TO IDENTIFY SAMPLES IN STATUS

SCREEN?

Document only for Training use. Does not replace the User Manual. Refer to MINI VIDAS®user’s manual for detailed data

HOW TO RUN SAMPLES?

1. Select Start.

2. If required, select User ID.

Reaction starts: the green LED of the section lights up

Reaction ends: the green LED ashes.

Results print out automatically.

At the end, remove the strip(s) and SPR(s) of the section.

HOW TO PERFORM USER MAINTENANCE?

Monthly:

Cleaning of the SPR®block

Cleaning of the two optical lenses

Performing VIDAS®QCV test

Every 6 Months:

Cleaning of the reagent strip area

Yearly:

A preventive maintenance has to be done by a bioMérieux representative.

Performing VIDAS

QCV test

1. Press start (No position identication required).

2. After 20 min, results print out automatically.

Quality Control VIDAS (QCV) is used to

detect abnormal operation of pipette

mechanisms which may aect the results of

biological tests.

It is also intended for checking that the

optical system is capable of measuring high

uorescence levels.

QCV test must be run in EVERY position.

Place SPR®and strips in each position of

each section.

VIDAS®QCV reference 30706

INTERPRETATION OF QCV TEST:

Check the TV1 value and R3 value

for each position.

IN CASE OF OUT OF RANGE RESULTS:

For TV1: If the result of a particular position is outside the range, two new VIDAS®

QCV tests must be run successively in all the positions in the section concerned.If at

least one other non-compliant result is produced in the same section, independent

of the position: PUT THE SECTION OFFLINE and Call bioMérieux Technical Support.

For R3: If the result of a particular position is outside the range:

PUT THE SECTION OFFLINE and Call bioMérieux Technical Support.

TV1 must be > = the value indicated on

the kit label.

HOW TO PERFORM AND INTERPRET QCV

TEST?

Please follow instruction in package insert of the reagent

If required, leave reagents 30 min at room temperature before use.

Check the type of sample and pre-process samples if required.

Place the strip(s) and SPR®(s) into the section indicated on the screen.

Dispense the sample volume into the sample well of the strip.

Repeat the same actions for each sample.

Document only for Training use. Does not replace the User Manual. Refer to MINI VIDAS®user’s manual for detailed data

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ANNOTATIONS

01-18 / 9312787-008-GB-E - Document and/or pictures not legally binding. Modifications by bioMérieux can be made without prior notice - The BIOMERIEUX logo, SPR and VIDAS are used, pending and/or registered trademarks belonging to

bioMérieux 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 to the property of its respective owner / bioMérieux S.A. 673 620 399 RCS Lyon /