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FilmArray
®
Gastrointestinal Panel
(Injection Vials)
To avoid contamination always wear gloves and work behind a protective shield.
Step 1: Prepare Pouch
q Insert pouch into Pouch Loading Station.
q Place Sample Injection Vial into red well.
q Place Hydration Injection Vial into blue well.
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
Step 2: Hydrate Pouch
q Unscrew Hydration Injection Vial, leaving cap in Pouch Loading
Station, and insert into pouch hydration port.
q Forcefully push down to puncture seal and wait as Hydration Solution
is drawn into pouch.
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
Step 3: Prepare Sample Mix
q Add Sample Buffer to Sample Injection Vial:
• Invert Sample Buffer Ampoule so that tip is facing up.
Note: Do not touch the tip of the ampoule.
• Firmly pinch textured plastic tab on side of ampoule until seal snaps.
• With the tip facing down, dispense Sample Buffer into Sample
Injection Vial using a slow, forceful squeeze, followed by a 2nd
squeeze. Avoid generating excessive bubbles.
q Thoroughly mix stool specimen in transport media.
q Using transfer pipette, draw up specimen to 2nd line.
q Add to Sample Injection Vial.
q Tightly close lid of Sample Injection Vial.
q Mix sample by gently inverting Sample Injection Vial 3 times.
q Return Sample Injection Vial to red well of Pouch Loading Station.
Warning: The Sample Buffer is harmful if swallowed, can cause
serious eye damage and/or skin irritation.
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
x3
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
Step 4: Load Sample Mix
q Unscrew Sample Injection Vial from cap.
q Pause for 3-5 seconds, then remove Sample Injection Vial, leaving
cap in Pouch Loading Station.
q Insert Sample Injection Vial into pouch sample port.
q Forcefully push down to puncture seal.
q Wait as Sample Mix is drawn into pouch.
x3
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
BioFire Diagnostics, LLC
390 Wakara Way
Salt Lake City, Utah 84108
USA
FLM1-SUB-0065
0:05
Step 5: Run Pouch
q Follow instructions on computer for initiating a test.
q The pouch will click into place when properly seated.
Note: If the pouch does not insert easily, ensure that the lid is opened completely.
FilmArray
™
Panel
Page 2
3. ' Detected', pathogen was detected
4. 'Not Detected', pathogen was not
detected
5. ' ø N/A', pathogen was not reported.
Refer to Instruction Booklet for more
information.
TM
Example
1. 2.
TM
4.
5.
3.
TM
Ashley Hunter (ah)
ITI FA "FA1115"
6.
The Run Summary Section displays information about the sample and a summary of the
control and test results.
1. Detected:
• Names of any detected pathogens
• If “None”, no pathogens were
detected
• If “ Invalid”, RETEST SAMPLE
2. Controls:
• If “Passed”, results are valid
• If “
Failed”, RETEST SAMPLE
• If “ Invalid”, RETEST SAMPLE
The Results Summary Section lists the test results for each pathogen targeted
by the Respiratory Panel.
6. Run Status: If Completed, run is
complete.
If Incomplete, Aborted, Instrument
Communication Error, Instrument Error
or Software Error, RETEST SAMPLE.
Note: If repeated “Error” messages are obtained contact BioFire Diagnostics, the local bioMérieux sales representative, or an
authorized distributor.
The Run Details Section displays information about the pouch, instrument,
run status and operator.
Understanding the FilmArray Run Report
Mar. 2015 / RFI T-PRT-0490- 01 / FR / A / bioMérie ux S.A. RCS Lyo n 673 620 399 / Impr inted in France.
Manufactured by:
BioFire Diagnostics, LLC
390 Wakara Way, Salt Lake City,
UT 8 4108, USA
BioFire is a subsidiary 100% owned by bioMérieux.
www.biofiredx.com
bioMérieux S.A.
69280 Marcy I’Etoile
France
Tel.: +33 (0) 4 78 87 20 00
Fax: +33 (0) 4 78 87 20 90
www.biomerieux.com
The purcha se of this product i ncludes a limited, n on-transferab le license under sp eci c claims of one or m ore US patents lis ted on the BioFi re Diagnostics w ebsite (htt p://www.bio redx.com/L egalNotices /) owned by B ioFire and/or t he Research Fou ndation of The Un iversity of Ut ah. The blue logo, B ioFire
and FilmA rray logos, and BI OMÉRIE UX, BIOFI RE, and FILM ARRAY are us ed, pending, and/o r registered trade marks belonging to b ioMérieux or Bio Fire or one of their sub sidiaries or comp anies. Document an d/or picture not le gally binding. Modi cations can be made wit hout prior notice . No part of this
document ma y be reproduced or tr ansmitted in any for m or by any means, elect ronic or mechanica l, for any purpose, wi thout the express w ritten permiss ion of bioMérieu x / BioFire Diagnos tics.
TM
®
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