mini VIDAS Simplified User Guide Feb 2010

HOW TO KNOW IF A CALIBRATION IS VALID?

● If the lot does not feature in the list,

the lot has not been calibrated: To do this, proceed as follows: Press

Press three times to return to the MAIN MENU and follow the protocol on page 4

until the MAIN MENU is displayed

Select the Master lot menu

Select List Stored Stds

● If the lot features in the list, check whether the calibration

is still valid: Press on the key corresponding to the lot required, and the following screen will be displayed:

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● If the calibration has expired:

Select the test code in the list by pressing on the key to scroll down/up if necessary Test code

Press three times to return to the MAIN MENU and follow the protocol on page 5 ● If the calibration is still valid:

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SE E E PACKAG INSERT

Control the lot expiration date displayed on the screen

● If the test does not feature in the list, the test has not been

calibrated: Press twice to return to the MAIN MENU and follow the protocol on page 4

Press three times to return to the MAIN MENU and follow the protocol on page 6 IMPORTANT: The key enables the user to return to the MAIN M ENU at any time.

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HOW TO UPDATE A PROTOCOL? Always read the protocole barcode before reading the MLE card

● If the test features in the list, check whether the calibration is

still valid:

MAIN MENU Select the Utility Menu

Select the lot if necessary

Select Assay Update

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2

Fulfil the warning instructions and click on Yes to continue

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Read the protocole barcode printed on last page of the package insert with the barcode wand

As soon as the message disappears, remove the card and support Press

to return to the MAIN MENU

Then calibrate using the protocol below

HOW TO RUN STANDARDS (S) AND CONTROLS (C) FOR CALIBRATION?

Select Confirm to Quit

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If an error is made when selecting a standard, control or sample: • select the position n° to be modified (1 to 6) • select “Assay” • select “Clear” • select “Clear this position’s setup only”

HOW TO READ A MLE CARD? MAIN MENU MAIN MENU

Select Status Screen

Select section A or B

Select the Master Lot Menu

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q Place the MLE card on the white plastic card support Slide the card support into an empty section Type 1

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Select Read Master Lot

Select S for the standard, type 1, then press

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Select the chosen section

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The message “Please wait” is displayed on the screen

Repeat this operation for each standard used for the test

SE E E PACKAG INSERT

5

Select C for control, type 1 for C1 SE E E then press PACKAG

Enter the Sample ID (see below) and, if necessary, the dilution factor

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INSERT

Repeat this operation for each control used for the test Then follow the protocol below from

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IMPORTANT: The key enables the user to return to the Main Menu at any time.

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Press After identifying the last patient, press until the work list for the section is displayed, then start running the samples using the protocol below Sample identification (maximum of 12 alphanumeric characters) Numeric characters are entered using the keyboard Alphabetic characters are entered by selecting each character on the screen:

HOW TO IDENTIFY SAMPLES IN STATUS SCREEN?

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MAIN MENU Select Status Screen

Select a free section

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Use the arrow pad on the keyboard to move the cursor and select the characters, then validate them one by one by pressing Sample ID can also be entered by using the barcode wand

HOW TO RUN SAMPLES? Type 1

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Select Sample ID

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

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6

SE E E PACKAG INSERT

Repeat the same actions for each sample 7

If required, select User ID, if not press

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02-10 / 008GB99071C / This document is not legally binding. bioMérieux reserves the right to modify specifications without notice / BIOMERIEUX and the blue logo, are registered and protected trademarks belonging to bioMérieux S.A. or one of its subsidiaries / bioMérieux SA RCS Lyon 673 620 399 / Printed in France / THERA Conseil / RCS Lyon B 398 160 242

Select Start

GCS / IMMUNOASSAYS SIMPLIFIED USER GUIDE

Reaction starts: the green LED of the section lights up Test time SE E Reaction ends: the green LED flashes

E PACKAG INSERT

Remove the strip(s) and SPR(s) of the section Results print out automatically SE E Interpretation and E ACKAG P measurement range INSERT

mini VIDAS

®

2010/02/01

HOW TO PERFORM MAINTENANCE? Weekly: - cleaning of the SPR blocks

SE E IDAS MINI V USE R L MANUA

Monthly: - cleaning of the reagent strip area - performing VIDAS QCV test - cleaning of the two optical lenses

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

S SEE LEN R CLEANE E PACKAG INSERT