TEMPO
®
QC
12767
B
-
en - 2007/12
bioMérieux
®
SA
au capital de 12 029 370
€
673 620 399 RCS LYON
69280 Marcy-l'Etoile / France
Tel. 33 (0)4 78 87 20 00
Fax 33 (0)4 78 87 20 90
http://www.biomerieux.com
bioMérieux, Inc
Box 15969,
Durham, NC 27704-0969 / USA
Tel. (1) 919 620 20 00
Fax (1) 919 620 22 11
Printed in France
bioMérieux, the blue logo and TEMPO are used, pending and/or registered trademarks belonging to bioMérieux SA or one
of its subsidiaries.
READING AND INTERPRETATION
1. Open the TEMPO Check application on the reading
station.
2. Introduce the reading rack into the TEMPO Reader
and start the reading. The TEMPO Reader checks that
the cards are in the correct positions in the rack, by
scanning each of the barcodes, then detects and
interprets the fluorescence for each card.
3. Consult the test results display and management
screen. Once the reading is completed, the results are
automatically analyzed by the computer, which
determines whether the reader is functioning correctly,
by comparing the results to the range of expected
fluorescence values.
4. Remove the cards from the rack and dispose of them
into an appropriate receptacle.
EXPECTED RESULTS
When reading of the TEMPO QC cards is completed, the
screen for the display and management of the results of
the TEMPO Reader measurement performance controls
displays the results:
-
: The reader functions correctly.
-
: The reader functions correctly but you must be
extremely vigilant when the next controls are
performed.
-
: See "Troubleshooting" section below.
Troubleshooting
¾
Check if the storage conditions (2-8°C and no
exposure to direct light) and instructions for use (allow
the kit to come to room temperature before use) have
been respected.
¾
Change the position of the card with
status
*
and
read again.
¾
If the result of the control is still red (
), perform the
control again using another QC kit which has been
correctly stored and allowed to come to room
temperature before use.
¾
If the result of the control obtained with this second
QC kit is still red (
), change the position of the card
with
status
*
and read again.
¾
If the result of the control is still red (
), please
contact bioMérieux SA or its local representative.
*
making sure the 8µM cards are in positions 1, 2 and 3
and the 20 µM cards are in positions 4 and 5.
NOTE: A maximum number of 2 readings can be
performed with each kit.
WASTE DISPOSAL
It is the responsibility of each laboratory to handle waste
and effluents produced according to their nature and
degree of hazardousness and to treat and dispose of
them (or have them treated and disposed of) in
accordance with any applicable regulations.
INDEX OF SYMBOLS
Symbol
Meaning
GB: Catalogue number
US: Catalog number
Manufacturer
Temperature limitation
Protect from light
Use by
Batch code
Consult Instructions for Use
WARRANTY
bioMérieux disclaims all warranties, express or implied,
including any implied warranties of MERCHANTABILITY
AND FITNESS FOR A PARTICULAR USE. bioMérieux
shall not be liable for any incidental or consequential
damages. IN NO EVENT SHALL BIOMERIEUX’S
LIABLITY TO CUSTOMER UNDER ANY CLAIM
EXCEED A REFUND OF THE AMOUNT PAID TO
BIOMERIEUX FOR THE PRODUCT OR SERVICE
WHICH IS THE SUBJECT OF THE CLAIM.
