BioFire Inc. FilmArray operator's manual

FilmArray, 2016. — 59 p.This document is used solely for the purpose of FilmArray Instrument operation. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of BioFire Diagnostics, LLC.
Always maintain the instrument in good working order. If the instrument is used in a manner not specified by BioFire Diagnostics, LLC, then protection provided by the equipment may be impaired. A printed version of this manual is available upon request.
The FilmArray Instrument is an automated in vitro diagnostic (IVD) device designed to work with specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens. The instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray Software automatically interprets the results and provides an easy-to-understand test report.E-labeling.
Customer and Technical Support.
Instrument Manual Symbols.
Abbreviation of Terms.
FilmArray System.
FilmArray Intended Use.
Limitations of Use.
FilmArray Installation.
Components of the FilmArray System.
FilmArray Instrument.
FilmArray Accessories and Laptop Computer.
Installing the FilmArray Instrument.
Installation and Setup Requirements.
Unpacking the Instrument.
Connecting the Computer and FilmArray Instrument.
Turning on the Laptop Computer and FilmArray Instrument.
Principles Of Operation.
PCR Basics.
Nested Multiplex PCR.
High Resolution Melting Analysis.
Components of the FilmArray System.
FilmArray Pouch.
FilmArray Instrument.
Performance Specifications.
FilmArray Specifications.
Computer Specifications.
FilmArray Operating Instructions.
Components of a FilmArray Reagent Kit.
How to Perform a FilmArray Test.
General Precautions.
Starting the Software.
Pouch Loading Considerations.
Hydrating the Pouch.
Mix and Load the Sample.
Label the Pouch with a Sample ID.
Start a FilmArray Run.
View and/or Print a Run Report.
Viewing Error Messages.
FilmArray Software.Logging onto Windows.
Logging Off the Computer.
Instrument Control.
Understanding the Instrument Control Window.
Using the Browse Runs Tab to Search and View Run Data.
Quick Search.
Advanced Search.
Notes and Tags.
Viewing Control Results.
Managing Instrument Connections.
Creating New Operators.
Deleting Operators.
Modifying Operators.
PCR Evaluator.
Understanding the PCR Evaluator Window.
Managing the Database.
Archiving and Restoring Runs.
Exporting and Importing Runs.
Exporting Anonymous Runs.
System Administrator Tasks (Windows).
Precautions when Working with the FilmArray System.
Laboratory Safety and Biohazards.
General Safety Precautions.
Laboratory Precautions.
General PCR Precautions.
Decontamination and Cleaning Procedures.
Cleaning Materials.
Decontamination of the Pouch Loading Station.
Decontamination Related to Pouch Leakage.
Instrument Decontamination.
Decontamination of Bench Tops and Other Areas.
Check Function of Decontaminated Instrument.
Preventative Maintenance and Troubleshooting.General Maintenance.
Using Error Reporting Tools.
Troubleshooting.
Hardware Troubleshooting.
Barcode Scanner.
Diagnostic Errors.
Software Troubleshooting.
Pouch Troubleshooting.
Appendices.
Instrument Return Procedures.
Return Procedures.
Return Instrument Check List.
Decontamination Labels.
FilmArray Customer Support Information.
FilmArray Ordering/Re-ordering Instructions.
Warranty Information.
APPENDIX C: Barcode Calibration.