BioFire FilmArray Torch Manual

HTFA-ASY-0102
HTFA-SUB-0103
HTFA-ASY-0104
Operator’s Manual
For In Vitro Diagnostic Use
®
This document is used solely for the purpose of FilmArray
Torch operation.
Always maintain the FilmArray Torch in good working order.

If 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.
BioFire Diagnostics, LLC Qarad b.v.b.a.

515 Colorow Drive Cipalstraat 3
Salt Lake City, UT 84108 B-2440 Geel, Belgium
USA
FilmArray® Torch Operator’s Manual IVD HTFA-PRT-0001-03 June 2017
© Copyright 2007–2017, BioFire Diagnostics, LLC All rights reserved.
The information contained in this document is subject to change without notice. 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.
BioFire Diagnostics makes no warranties regarding this material, including, but not limited to implied warranties of merchantability and fitness for a
particular purpose. BioFire Diagnostics will not be liable for errors contained herein or for incidental consequential damages in connection with the
furnishing, performance, or use of this material.
FilmArray software, Detector, and Metacall software Modules © 2002–2017 BioFire Diagnostics, LLC
BioFire Diagnostics, BioFire, the BioFire logo, FilmArray and LCGreen are trademarks of BioFire Diagnostics, LLC or BioFire Defense, LLC and
are registered trademarks of BioFire Diagnostics, LLC or BioFire Defense, LLC in the United States.
The purchase of this product includes a limited, nontransferable license under specific claims of one or more U.S. patents as listed on BioFire
Diagnostics, LLC’s Web site (http://www.biofiredx.com/LegalNotices/index.html) and owned by the University of Utah Research Foundation and/
or BioFire. The purchase of this product also includes a limited, non-transferable license under U.S. Patent No. 5,871,908, owned by Evotec
Biosystems GmbH and licensed to Roche Diagnostics GmbH.
Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.
E-Labeling
The manual for this product can be accessed online at www.online-ifu.com/KEY-CODE. The product
KEY-CODE is provided on the outer box label at the end of the URL. The KEY-CODE for this opera-
tor’s manual is also listed below. Additionally, a paper copy is available upon request by contacting
customer service via phone, fax, e-mail, or regular mail.
FilmArray Torch Operator’s Manual http://www.online-ifu.com/ITI0066

FilmArray Torch Information Quick Guide http://www.online-ifu.com/ITI0077
Customer and Technical Support

Customer and Technical Support for U.S. Customers
Reach Us on the Web Reach Us by Phone
www.biofiredx.com 1-800-735-6544 –Toll Free
(801) 736-6354 - Utah
Reach Us by E-mail
[email protected] Reach Us by Fax
(801) 588-0507
Reach Us by Mail
515 Colorow Drive
Salt Lake City, UT 84108
USA
Customer and Technical Support Outside of the U.S.

Contact the local bioMérieux sales representative or an authorized
distributor for Customer Support.
FilmArray Torch Operator’s Manual CE IVD <i>

Symbols Glossary
The following symbols can be found on the FilmArray Torch Modules, the System Base, the
Duplex(es), the FilmArray pouches, or throughout this manual. Use the definitions below as a guide-
line to interpreting the symbols.
ISO 15223-1:2012
Medical devices - Symbols to be used with medical devices labels, labeling and information to be supplied
5.1.1 5.1.2 5.1.4

Authorized representa-
Use By
Manufacturer tive in the European
(YYYY-MM-DD)
Community
5.1.5 5.1.6 5.1.7

Batch Code
Catalog Number Serial Number
(Lot Number)
5.2.8 5.3.4 5.3.7

Do Not Use if Package
Keep Dry Temperature Limit
Is Damaged
5.4.1 5.4.3 5.4.4

Consult Instructions
Biological Risks Caution
for Use
5.5.1
In vitro Diagnostic Medical Device
IEC 60417
Graphical Symbols for Use on Equipment
5007 5008 5019

On Off Protective Ground
5032 5988
Alternating current Computer Network
Underwriter’s Laboratory Listing Mark for

ISO 7000 USB Implementers Forum
Canada and the United States
1027 Underwriter’s
Reset Laboratory Listing USB Cable
Mark
European Union Directive 98/79/EC of the European

European Directive 2012/19/EU on waste electrical and electronic
Parliament and of the Council on in vitro Diagnostic
equipment (WEEE)
Medical Device
European Union Conformity WEEE - Do not throw in trash
Manufacture Symbols (BioFire Diagnostics, LLC)
NOTE - explains how to

Consult Instructions Consult Instructions
operate the instrument more
for Use - Online for Use - Phone
efficiently
< ii > FilmArray Torch Operator’s Manual CE IVD

Contents
Abbreviation of Terms
A ��amp (ampere)
cm ��centimeters
DNA ��deoxyribonucleic acid
dNTP ��deoxyribonucleotide triphosphate
kg..................................kilograms
Hz ��hertz
in ��inches
IVD ��in vitro diagnostic
lbs ��pounds
m ��meters
nmPCR ��nested multiplex PCR
PCR ��polymerase chain reaction
PPE ��personal protective equipment
RNA ��ribonucleic acid
RT ��reverse transcription
Taq ��enzyme from Thermus aquaticus
Tm ��melting temperature
VAC ��volt, alternating current
FilmArray Torch Operator’s Manual CE IVD < iii >

Contents
TABLE OF CONTENTS
E-Labeling ...............................................................................................i
Customer and Technical Support.............................................................i
Symbols Glossary...................................................................................ii
Abbreviation of Terms............................................................................iii
Chapter 1:
FilmArray Torch....................................................................................................1
FilmArray Torch Intended Use............................................................... 1
FilmArray Pouch.................................................................................... 3
FilmArray Torch ..................................................................................... 4
FilmArray Torch software ...................................................................... 5
Toolbar....................................................................................................................... 5
Chapter 2:
FilmArray Torch
Components and Setup.......................................................................................7
FilmArray Torch System Base Box Contents ........................................................... 7
FilmArray Torch Module Box Contents...................................................................... 8
FilmArray Duplex Box Contents (Optional) .............................................................. 8
Setup Requirements.............................................................................. 9
FilmArray Torch Installation.................................................................. 10
FilmArray Torch System Base Setup....................................................................... 10
FilmArray Torch Duplex Installation......................................................................... 11
FilmArray Torch Module Installation........................................................................ 12
FilmArray Torch Module Removal........................................................ 13
Instrument Configuration Application
for FilmArray Torch............................................................................... 14
Start Instrument Configuration Application ............................................................. 14
Instrument Configuration Grid................................................................................. 14
Add FilmArray Torch Module .................................................................................. 15
Remove FilmArray Torch Module ........................................................................... 16
FilmArray Torch Module Status............................................................ 17
Connecting a Printer to FilmArray Torch.............................................. 18
Chapter 3:
Principles of Operation .....................................................................................19
PCR Basics.......................................................................................... 19
Nested Multiplex PCR............................................................................................. 20
High Resolution Melting Analysis............................................................................ 20
< iv > FilmArray Torch Operator’s Manual CE IVD

Contents
Chapter 4:
Performance Specifications..............................................................................22
FilmArray Torch System Specifications............................................... 22
Chapter 5:
FilmArray Torch Operating Instructions..........................................................24
FilmArray Reagent Kits........................................................................ 24
FilmArray Test Procedure.................................................................... 25
General Precautions................................................................................................ 25
Initiate Run.............................................................................................................. 25
Start Run................................................................................................................. 27
Abort Run................................................................................................................ 28
Finish Run............................................................................................................... 29
View Report............................................................................................................. 29
Print Report............................................................................................................. 29
Error Messages....................................................................................................... 30
Chapter 6:
FilmArray Torch software..................................................................................31
FilmArray Torch Toolbar....................................................................... 31
Dashboard........................................................................................... 32
Browse Runs........................................................................................ 33
View Report Menu................................................................................................... 33
Search Run Data .................................................................................................... 35
Browse Runs Options Menu.................................................................................... 35
Settings................................................................................................ 38
Print Options............................................................................................................ 38
Operators................................................................................................................. 39
Pouch Modules........................................................................................................ 40
Archive Runs........................................................................................................... 41
Switch to Admin Mode............................................................................................. 43
Database Management........................................................................ 43
Chapter 7:
Precautions when Working
with the FilmArray System................................................................................44
Laboratory Safety and Biohazards...................................................... 44
General Safety Precautions..................................................................................... 44
Laboratory Precautions........................................................................................... 44
General PCR Precautions ...................................................................................... 45
Decontamination and Cleaning Procedures........................................ 45
Cleaning Materials................................................................................................... 45
Pouch Loading Station Decontamination ............................................................... 46
Decontamination Related to Pouch Leakage.......................................................... 46
FilmArray Torch Module Decontamination............................................................... 47
Decontamination of Bench Tops and Other Areas.................................................. 47
Check Function of Decontaminated FilmArray Torch Module................................. 48
FilmArray Torch Operator’s Manual CE IVD <v>

Contents
Chapter 8:
Preventative Maintenance and Troubleshooting.............................................49
Introduction.......................................................................................... 49
General Maintenance........................................................................... 49
Troubleshooting................................................................................... 50
Pouch Troubleshooting............................................................................................ 50
Warning Messages.................................................................................................. 51
Hardware Troubleshooting...................................................................................... 51
Error Messages ...................................................................................................... 52
Diagnostic Errors..................................................................................................... 53
Error Reporting Tools........................................................................... 54
System Log.............................................................................................................. 54
Error Bundle ........................................................................................................... 55
Appendix A:
FilmArray Support Information.........................................................................56
FilmArray Torch Module Return Procedure......................................... 56
Disposal Recommendation.................................................................. 56
FilmArray Ordering Instructions........................................................... 56
Warranty Information............................................................................ 57
Appendix B:
Barcode Calibration............................................................................................58
< vi > FilmArray Torch Operator’s Manual CE IVD

Chapter 1: FilmArray Torch
CHAPTER 1:
FILMARRAY TORCH
FilmArray Torch Intended Use
The FilmArray Torch is an automated in vitro diagnostic (IVD) device intended for use with FDA
cleared or approved IVD FilmArray panels. The FilmArray Torch is intended for use in combination
with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical
specimens. The FilmArray Torch interacts with the reagent pouch to both purify nucleic acids and
amplify targeted nucleic acid sequences using nested multiplex PCR (nmPCR) in a closed system.
The resulting PCR products are evaluated using DNA melting analysis. The FilmArray Torch software
automatically determines the results and provides a test report.
The FilmArray Torch is a modification of FilmArray 2.0 and is composed of two to twelve FilmArray
Torch Modules connected to a FilmArray Torch System Base running FilmArray Torch software. The
FilmArray Torch System Base houses two FilmArray Torch Modules. Up to five Duplex Module
enclosures, each capable of housing two additional Torch Modules, may be added on top of the
FilmArray Torch System Base. Each FilmArray Torch Module can be randomly and independently
accessed to run a reagent pouch. The FilmArray Torch software controls the function of each
FilmArray Torch Module and collects, analyzes, and stores data generated by each FilmArray Torch
Module.
FilmArray Torch Operator’s Manual CE IVD <1>

Limitations of Use
• This product can be used only with FilmArray pouches.
• For prescription use only.
• The FilmArray Torch is intended to be used in combination with FilmArray panels that have been
FDA cleared for use on the FilmArray Torch.
• Do not remove the FilmArray Torch Module(s) front cover during a run.
• Use only the supplied cables when connecting any FilmArray Torch Module to the FilmArray
Torch System Base.
• Do not use cable extenders to increase cable length.
• Do not install any software other than the BioFire Diagnostics FilmArray Torch software on the
System Base unless required by peripheral devices (printers, removable drives, other USB
devices).
• Do not enable Windows Automatic Updates on the System Base.
• Do not remove the default Windows user accounts
• Do not change screensaver settings on the System Base.
• Do not modify the FilmArray Torch software or configuration settings.
• Do not adjust system settings (such as date/time) while FilmArray Torch Modules are running.
• Do not re-run a pouch associated with an error, incomplete run, or invalid result.
• Only authorized service personnel should install and perform service or repairs on the FilmArray
Torch.
<2> FilmArray Torch Operator’s Manual CE IVD

FilmArray Pouch
Each FilmArray pouch is a self-contained, closed-system disposable that houses all the chemistry
required to isolate, amplify, and detect nucleic acid from a sample. The reservoirs in the rigid plastic
component, or fitment, of the pouch (A) contain freeze-dried reagents. The flexible plastic film portion
of the pouch (B) is divided into discrete segments (blisters) which, via interactions with actuators and
sensors in the FilmArray Torch Module, are where the following chemical processes are performed:
(C) Extraction and purification of nucleic acids from a clinical sample using mechanical lysis (bead
beating) and magnetic bead technology
(D) First-stage multiplex PCR (including reverse transcription of target RNAs when appropriate)
(E) Second-stage singleplex PCR and melting analysis within a multi-well array
Fitment
A and Pouch
Label
B Plastic Film
Pouch
C D E
Nucleic Acid Extraction Reverse Transcription and Second-stage
and Purification First-stage Multiplex PCR Singleplex PCR
NOTE: The colored liquid in this image of a FilmArray pouch is for visualization only.
FilmArray pouches do not contain any colored fluid.
Each pouch contains at least one internal process control. Control material is lysed and the nucleic
acids of the control material are extracted along with that of the organisms contained in the sample.
When the internal control is positive, proper operation of the FilmArray Torch Module and chemical
processes have been demonstrated.

FilmArray Torch
Major components and operations of the FilmArray Torch are described below. A full list of
components can be found in Chapter 2 and specific step-by-step operating instructions can be found
in Chapter 5.
FilmArray Torch Module

Interacts with the reagent
FilmArray Torch Duplex pouch to purify and am-
Module enclosure; houses plify targeted nucleic acid
two FilmArray Torch sequences using nmPCR;
Modules includes pouch slot and LED
status light
FilmArray Torch
System Base
Includes barcode scanner,
touch screen, and USB ports
FilmArray Pouch Modules

Each FilmArray reagent pouch requires a pouch specific software called a pouch module to be
installed on the FilmArray Torch in order to perform a test. These pouch modules contain definitions,
protocols, analysis and reporting for specific FilmArray reagent kits. See the Pouch Modules section
in Chapter 6 for more information.
FilmArray Pouch Preparation

Refer to the Procedure section of the appropriate FilmArray reagent kit instruction booklet for step-
by-step instructions for sample and pouch preparation.
FilmArray Torch Runs

The FilmArray Torch is used in combination with FilmArray reagent pouches to perform tests,
also known as runs, that detect multiple nucleic acid targets contained in clinical specimens. The
FilmArray Torch interacts with the reagent pouch to both purify nucleic acids and amplify targeted
nucleic acid sequences using nmPCR in a closed system.
The FilmArray Torch software includes a detailed workflow that guides the operator on how to per-
form a run. Once a pouch has been prepared for testing, on-screen instructions prompt the operator
to enter pouch and sample information, insert the pouch into an available Torch Module and start the
run. For more information on starting a FilmArray Torch run, see Chapter 5.

FilmArray Torch Module and Pouch Interaction

After the run is started, a series of plungers, pneumatic actuators, and hard seals work together
to move and mix liquid reagents between the blisters of the pouch. The FilmArray Torch Module
controls these functions automatically based on the pouch module run protocol selected for a
specific pouch and sample type in the FilmArray Torch software.
Mechanical Lysis
The first step in processing a sample is to break the outer membrane of the target cells or organisms
contained in the sample using a device called a bead-beater. A sensor detects the speed and
operation of the bead-beater motor and aborts the run if the bead-beater is not working properly.
Nucleic Acid Extraction

Following bead-beating, the nucleic acids contained in the sample are purified by magnetic bead
technology. A retractable magnet is used to capture or release the magnetic beads during washes.
Thermal Control
The purified nucleic acids are mixed with PCR reagents, which amplify all of the targets identified
by the pouch as well as the control material. A Peltier device drives the thermocycling (heating and
cooling of the solution) of the reverse transcription and/or first-stage PCR reactions. A second Peltier
device controls thermocycling for second-stage PCR and DNA melting. These reactions take place
in the array located in the final pouch blister. The thermocycling conditions are controlled by the run
protocol associated with each specific reagent pouch and sample type.
Optics and Imaging

To identify targets from positive PCR reactions, DNA melting curve analysis is performed. The
fluorescence emitted by the LCGreen® Plus dye is imaged by a camera. DNA melting curves are
captured by slowly increasing the temperature of the PCR array and capturing the fluorescent
signal. These images are processed automatically by the System Base, and the data is analyzed to
determine if the control reactions passed and which targets were detected in the sample.
The optics system contained in the FilmArray Torch Module is aligned, focused, and calibrated at
the factory. Proper operation and calibration of FilmArray Torch Module optics is monitored by the
FilmArray Torch Module self-tests and internal pouch controls.
FilmArray Torch software

The FilmArray Torch software manages and controls the operation of each FilmArray Torch Module.
The software also collects, stores, and analyzes data generated by the FilmArray Torch Module.
Results of analyses are presented in a test report. A brief overview of major software components
are described below. For more detailed information about the features and operation of the FilmArray
Torch software, see Chapter 6, FilmArray Torch software.
Toolbar
The toolbar always displays at the top of the screen and consists of three options:
• Dashboard
• Browse Runs
• Settings

Dashboard
Displays the status of each FilmArray Torch Module within the FilmArray Torch and guides the opera-
tor through the process of operating the Modules.
NOTE: The Dashboard display may be different dependent upon the number of Modules
configured.
Browse Runs
Allows operators to search for runs and perform operations on individual runs or on groups of runs.
Settings
Allows users to perform administrative type tasks, such as managing operators (adding and updat-
ing), view system logs, etc.

Chapter 2: FilmArray Torch Components and Setup
CHAPTER 2:
FILMARRAY TORCH
COMPONENTS AND SETUP
FilmArray Torch Components
Each FilmArray Torch comes with a FilmArray Torch System Base, two or more FilmArray Torch
Modules, and accessories. Optional Duplexes are available to house additional Modules (up to 12
total). The FilmArray Torch ships in a minimum of three boxes and a maximum of 18 boxes; one
System Base box, two to twelve Module boxes (one box per Module), and up to five Duplex boxes
(one for every two Modules after the first two Modules).
FilmArray Torch System Base Box Contents
NOTE: The FilmArray Torch System Base comes pre-loaded with the FilmArray Torch
software
FilmArray Torch System Base Top Cover System Base Cable Shroud
FilmArray Pouch
EU Power Cable US Power Cable
Loading Station
Information CD
HTFA-SFW-0160
Ver 1.0
HTFA-SCD-0001
Click on Start-Here.htm to begin.

No part of this CD may be reproduced or transmitted in any form HTFA-SFW-0160
or by any means, electronic or mechanical, for any purposes,

without the express written permission of BioFire Diagnostics.
Label No: HTFA-PRT-0008-01
Ethernet Cable FilmArray Torch Information CD Information CD
FilmArray Torch Operator’s Manual CE IVD HTFA-SFW-0160

Ver 1.0
<7>
HTFA-SCD-0001
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or by any means, electronic or mechanical, for any purposes,

without the express written permission of BioFire Diagnostics.
Label No: HTFA-PRT-0008-01
FilmArray Torch Module Box Contents
Module Front
FilmArray Torch Module Cover Filter
Long Ethernet Cable Long Power Cable Spare Filters (2x)
INFORMATION QUICK GUIDE
FilmArray Torch installation should only be performed by a BioFire Diagnostics-appointed specialist.

FilmArray Torch requires one power outlet. LIS connectivity requires a single data outlet.
FilmArray Torch (Front)

1. FilmArray Torch Duplex
1 2. FilmArray Torch Module
a. Module Reset
2 2a 3. Module Front Cover
4. Module Status LED Light
5. FilmArray Pouch Insert Slot
6. FilmArray Torch System Base
a. Touch Screen
b. Barcode Scanner
c. USB Ports (2)
3 FilmArray Torch (Back)

4 7. FilmArray Torch Top Cover
8. Back of Module
5
a. Power On/Off Switch
b. Ethernet Port
9. Duplex Cable Shroud
10. System Base Cable Shroud
6
11. System Base Power Port + On/Off
a. Power Inlet
6a b. Power On/Off Switch
12. System Base Reset + USB + Ethernet
6b
a. System Base Reset
b. USB Ports (2)
6c
c. Ethernet Port for LIS Connectivity
7
8a
8b 8
11a
11b
10
12b
12a 11
12c
12
Short Ethernet Cable Short Power Cable Information Quick Guide
FilmArray Duplex Box Contents (Optional)
FilmArray Pouch Duplex Cable Shroud

FilmArray Torch Duplex
Loading Station
NOTE: Duplexes ship separately in their own boxes.

Setup Requirements
Select a clean, well-ventilated area that is large enough to fit the FilmArray Torch.
• There must be at least 1 inch (2.6 cm) between the rear panels and any other surface (such as
the wall) to allow for proper air flow.
• The depth of the bench-top space should be at least 30 in (77 cm).
• The width of the bench-top space should be at least 19 in (49 cm).
• The height of the space required depends on the number of Modules installed:
• System Base – 11.5 in (30 cm)
• System Base + 1 Duplex – 16 in (41 cm)
• System Base + 2 Duplexes – 20.5 in (53 cm)
• System Base + 3 Duplexes – 25 in (64 cm)
• System Base + 4 Duplexes – 29.5 in (75 cm)
• System Base + 5 Duplexes – 34 in (87 cm)
NOTE: One Duplex holds two FilmArray Torch Modules.
• Power Specifications:
Qty. of Modules Voltage Frequency AC Current at 120V* AC Current at 240V*
2 3.2 A 1.7 A
4 5.0 A 2.8 A
6 6.9 A 3.8 A
100-240VAC 50-60Hz
8 8.8 A 4.8 A
10 10.6 A 5.8 A
12 12.5 A 6.9 A
*Grounded outlet required
NOTE: FilmArray Torch requires one dedicated circuit. A single data outlet is sufficient
for optional LIS connectivity.
The FilmArray Torch complies with the emission and immunity requirements in IEC 61326. It is
advisable to evaluate the electromagnetic environment prior to operating the device.
CAUTION: Do not use this device in close proximity to sources of strong electromag-
netic radiation (unshielded intentional radio frequency sources, for example) because these
may interfere with the operation of the FilmArray Torch.

FilmArray Torch Installation

CAUTION: FilmArray Torch installation should only be performed by a BioFire
Diagnostics appointed specialist. A brief description of the installation process is provided
below.
FilmArray Torch System Base Setup
CAUTION: Use only the supplied cables when

connecting the FilmArray Torch Modules to the
FilmArray Torch System Base. Do not use cable
extenders to increase cable length.
1. Remove all components in the System Base

box.
2. Place the System Base in desired location.
3. Plug in power and ethernet cord from the System Base to the wall.
4. Turn on power to the System Base; then check that the FilmArray Torch software powers on.
Module On/Off Switch
Module Ethernet
Ports Only
Module Power
Ports Only
System Base Ethernet Port

For LIS Connectivity
System Base On/Off
Switch
< 10 > FilmArray Torch Operator’s Manual CE IVD

FilmArray Torch Duplex Installation
NOTE: Duplex installation is performed if more than two Modules need to be installed. If
not, continue on to the FilmArray Torch Module Installation section in this chapter.
1. Remove all components from the Duplex box(es).
2. Loosen screw to remove the spring brackets at the rear of the top cover (leave the screw
threaded in below).
Spring Bracket
Leave screws
3. Stack a Duplex Module enclosure on top of the System Base/lower Duplex and align the key-
holes with the screws in the base/Duplex below.
Keyhole
Align with screw
4. Slide the new Duplex back until the front edge is aligned with the Duplex below it; then tighten
the fasteners.
5. Repeat steps 3 – 4 until all Duplexes are installed (up to five Duplexes).
6. Reinstall the top cover spring brackets on the top Duplex (at the rear holes) and tighten the
screws.
FilmArray Torch Operator’s Manual CE IVD < 11 >

7. Align the top cover straps with the spring brackets; then slide the top cover back until the tabs
align with the front of the top Duplex.
Top Cover Strap
8. Fasten with washers and screws.
Washer
Screw
FilmArray Torch Module Installation

Unplug the FilmArray Torch before beginning.
1. Remove all contents from the Module boxes.
2. If necessary, install all Duplexes (see the FilmArray Duplex Installation section previously in
this chapter for instructions).
3. Loosen the two screws on the front of the preinstalled tabs.
4. Starting at the bottom and working up, install Modules into the front of each Duplex opening
and secure each with washers and screws.
5. Using the power and ethernet cables, connect each Module to the back of the System Base.
The labels next to the AC power connectors on the System Base will indicate the optimal cable
routing order.
6. Turn on power to each Module using the power switch on the back of each Module (see image
in the FilmArray Torch System Base Setup section previously in this chapter for more informa-
tion).

7. Install cable shrouds over the electrical cables. The shrouds attach by aligning the magnets on
the back of each Duplex with the holes in the strikers.
8. Ensure the filters are in place on the back of each Module front cover; then attach a front
cover to each Module by aligning the mounting posts with the alignment holes in the plastic.
9. Plug the System Base power cord into a power source; then plug the System Base Ethernet
cable into desired Ethernet port.
10. Turn the FilmArray Torch on using the power switch on the back of the System Base near the
power cord.
NOTE: Routine shutdown is not required for FilmArray Torch. To properly turn off, first
press the reset button on the back of the System Base until the screen goes black; then turn
off the main power switch near the System Base power cord.
FilmArray Torch Module Removal

1. Remove the cable shroud from the back of the Module and turn off the Module to be replace.
2. Disconnect the cables and remove the Module front cover.
3. Unscrew the washers and screws on the front of the Module; then carefully slide the Module
out of its Duplex.
NOTE: If installing a replacement Module, install using the steps in the previous section.

Instrument Configuration Application

for FilmArray Torch
The FilmArray Torch System Base is preinstalled with the Instrument Configuration application. Once
connected physically to the System Base, the Instrument Configuration application allows an opera-
tor to add or remove Modules to the FilmArray Torch software.
NOTE: A Module must be added to the FilmArray Torch before the software can be used
to initiate and perform runs.
Start Instrument Configuration Application

To access to the application from the FilmArray Torch software:
1. Navigate to the Settings toolbar and select Switch to Admin Mode.
A confirmation message will appear.
2. Select Yes on the message to exit the FilmArray Torch software.
A Windows login screen will appear after the software closes.
3. Log into Admin Mode by entering a valid username and password (see the Switch to Admin
Mode section in Chapter 6 for more information).
4. When the Windows desktop displays, double-tap the icon.
Instrument Configuration Grid

The Instrument Configuration grid is broken into 12 boxes that represent the physical locations for all
12 potential Modules. Each Module that is currently configured to the FilmArray Torch displays within
a box. Any boxes that have not had a Module configured to them contain a plus icon .

NOTE: Start initial configuration from the bottom and work up. Modules should be config-
ured to correspond with the physical location(s) on the FilmArray Torch.
Grid Box
The grid box represents a single location within the FilmArray Torch.
Each Module configured to the FilmArray Torch displays the following:
• Serial Number displayed as a title

• Firmware version
• Master version
• Thermoboard version
• Valveboard version
• Status
• Runs Since Last Service
• Blink LED identifies which physical Module is linked to the appropriate location. The Module
LED blinks white when the Blink LED option is selected. The Blink LED option is unavailable if
the Module is disconnected.
• Remove (see the Remove FilmArray Torch Module section below)
Add FilmArray Torch Module

To add a Module to the FilmArray Torch software:
1. Select the plus icon for the appropriate location.

The application presents the Detected Modules dialog.
2. Use the scroll bar to locate the applicable Module Serial Number and select Blink LED.
3. Use the plus icon to add the appropriate Module.
4. Select Save to save all changes made during this operation.
Remove FilmArray Torch Module

To remove a Module from the FilmArray Torch software:
1. Identify the location configured to Module and check that its status is Idle.
NOTE: There is no warning presented for removal of a FilmArray Torch Module that is
currently in a running status.
2. Select Remove on the applicable location.
3. Select the Save option to save all changes made during this operation.

FilmArray Torch Module Status

The front of each FilmArray Torch Module is equipped with an LED light that shows the specific sta-
tus of that Module.
LED Color Status Meaning
White Solid Module initializing.
Yellow Solid Warning - e.g., Module not connected.
Blue Solid Module idle and available to run a pouch.
Module waiting for operator to insert a

Blue Blink
pouch.
pouch inserted and seated, but pouch run

Green Fast Blink
not started.
Green Solid pouch run in progress.
Green Slow Blink Run complete - remove pouch

LED Color Status Meaning
Warning – Operator action required - e.g.,

unknown insertion, double insertion, pouch
Yellow Blink jam
Follow on-screen instructions.
Error. Operator intervention or maintenance

required.
Module must be reset. Remove the front

Purple Blink
cover of the affected Module and reset the
Module, or power off then power on the
Module.
Error. Operator intervention or maintenance

required.
Module must be reset. Remove the front

Red Solid
cover of the affected Module and reset the
Module, or power off then power on the
Module.
Connecting a Printer to FilmArray Torch

The FilmArray Torch can be configured to print to any printer compatible with a Windows 7 operating
system.
Add or Update Printer

1. Navigate to the Settings toolbar.
2. Select Switch to Admin Mode. A warning message informs the operator that switching to
Admin Mode will close the application and log off.
3. Select Yes to confirm the switch.
4. Enter the appropriate user name and password to log in. The standard Windows desktop lay-
out will display.
5. Navigate to the Control Panel to manipulate printer details for the FilmArray Torch.
6. Restart the System Base when printer maintenance is complete. The FilmArray Torch software
will automatically load.

Chapter 3: Principles of Operation
CHAPTER 3:
PRINCIPLES OF OPERATION
FilmArray is an automated in vitro diagnostic (IVD) system that utilizes nmPCR and high-resolution
melting analysis to detect and identify multiple nucleic acid targets from clinical specimens. The user
of the FilmArray Torch loads the sample into a reagent pouch, places the pouch into the FilmArray
Torch Module, and starts the run. The FilmArray Torch Module interacts with the reagent pouch to
extract nucleic acids from the sample and to amplify pathogen specific DNA sequences that are tar-
geted by the assays. The resulting PCR products are evaluated using DNA melting analysis and the
results are automatically determined and presented by the FilmArray software in a test report.
PCR Basics
Polymerase chain reaction (PCR) is the process of making billions of copies of DNA. Copies are
made by melting the DNA into separate strands and using each strand as a template for generation
of a new strand. To identify specific pathogens using PCR, primers (short pieces of a specific DNA
sequence) are included in the PCR reaction to target unique segments of the pathogen genome.
If the organism of interest has an RNA genome, a process called reverse transcription (RT) is per-
formed prior to PCR in order to convert the RNA template into a DNA template (RT-PCR).
There are 3 steps to a PCR cycle:
Step 1: Denaturation - The sample is heated to about 94°C to denature or ‘melt’ the double-
stranded target DNA into single strands.
Step 2: Primer annealing - The sample is cooled to about 60°C, allowing the primers to bind or
“anneal” to the target DNA strands at a specific site.

Step 3: Primer extension - an enzyme (Taq DNA polymerase) binds to the DNA/primer complex
and makes a copy of the original double stranded DNA by adding nucleotides (dNTPs A, G, T or C)
that are complementary to the nucleotide sequence of the target DNA.
At the end of a cycle, each piece of double-stranded target DNA has been duplicated. The new DNA
copies act as templates in the next cycles, so after 30 cycles, as many as 1 billion copies of a single
piece of DNA can be produced. With this duplication process, it becomes possible to detect DNA or
RNA from even a low concentration of pathogens in the original sample.
1 Cycle 2 Cycles 30 Cycles
Nested Multiplex PCR

nmPCR uses two stages of PCR. During the first-stage PCR, multiple “outer primers” are used to
perform multiplex PCR on the target templates present in the sample.
Second-stage PCR is performed in a singleplex format to further amplify the DNA copies generated
during the first-stage PCR. The “inner primers” used in second-stage PCR are made up of
1 Cycle 2 Cycles 30 Cycles
sequences “nested” within the first-stage PCR product(s).
High Resolution Melting Analysis

FilmArray PCR reactions contain the DNA binding dye LCGreen® Plus. LCGreen Plus is incorporated
into the copies of DNA as they are made during each PCR cycle. When bound to double-stranded
DNA, the dye fluoresces and the fluorescence is detected by the FilmArray Torch Module. As the
temperature is increased and the copies of double-stranded DNA melt, the LCGreen Plus dye is
released and a reduction in fluorescence is detected.

Copies of double-stranded DNA generated during PCR (called PCR products or amplicon) will
have unique sequences based on the template that was amplified. Amplicon length and sequence
determines the temperature at which the double-stranded DNA will melt apart, which is known as
the melting temperature (Tm) of the amplicon. PCR products made from different targets will have
different sequences and, therefore, different Tms.
After the last cycle of PCR, the FilmArray Torch Module gradually raises the temperature of the
reaction from approximately 60°C to 94°C. As the temperature reaches the Tm of an amplicon,
the amplicon denatures and fluorescence drops, releasing LCGreen Plus. This produces a melting
curve, seen in the graph below, which shows the rapid decline in fluorescence. A melting peak with a
specific Tm is generated for each amplicon by plotting the negative derivative of the melting curve.
Melting Peaks
Melting Curves
The FilmArray uses melting curve analysis to identify pathogen specific PCR product. Since the
sequence and Tm of an amplicon from a specific target is known and consistent, pathogen specific
PCR product can be identified as being copied from that target. Non-specific PCR products with
different Tms are excluded.

Chapter 4: Performance Specifications
CHAPTER 4:
PERFORMANCE SPECIFICATIONS
FilmArray Torch System Specifications
Sample Description • One sample capacity per FilmArray Torch Module (with up to
12 samples per FilmArray Torch)
Run Time • Sample run time about one hour
User Interface • System Base with touch screen and barcode scanner
Data Output • Automatic analysis with end-of-run result reports
Fluorescence Acquisition • Single color optics module: 475nm excitation, 545nm emis-
sion, and sensor imaging
Temperature Control • Operating temperature 15°C to 30°C
• Peltier devices:
• Ambient to 100°C
• Ramp rate from 0.1–0.5°C /sec on melt
Operations Specification • 15°C to 30°C @ 20 to 80% relative humidity (non-condensing)
• -16m to 3048m
• Indoor use only
Shipping Specifications • -30°C to 38°C @ 5 to 85% relative humidity (non-condensing)
• -16m to 10,600m
Power Requirements Qty. of Voltage Frequency AC Current AC Current
Modules at 120V at 240V
2 3.2 A 1.7 A
4 5.0 A 2.8 A
6 6.9 A 3.8 A
100-240VAC 50-60Hz
8 8.8 A 4.8 A
10 10.6 A 5.8 A
12 12.5 A 6.9 A
Fuse • 250V 3.15A Type T (Modules)

• 250V 10A Type T (System Base)

Chapter 4: Performance Specifications
Dimensions and Weight • 18 x 29 x 11.5 in (45.8 x 73.66 x 29.21 cm) (W x D x H;

System Base only)
• 4.5 in (11.43 cm) (H; Modules only)
• 34 in (86.36 cm) max height (12 Modules)
• Weight: Approximately 268 lbs (121.6 kg) maximum:
• System Base – 36 lbs (16.3 kg)
• Modules – 15 lbs (6.8 kg) each
• Duplex (Module enclosure) – 6.5 lbs (2.95 kg) each
EMC Requirements • The FilmArray Torch complies with the emission and immunity
requirements in IEC 61326: Electrical equipment for measure-
ment, control and laboratory use - EMC requirements - Part 1:
General requirements.
Safety Requirements • The FilmArray Torch complies with IEC 61010-2-101: Safety
requirements for electrical equipment for measurement, control
and laboratory use - Part 2-101: Particular requirements for in
vitro diagnostic (IVD) medical equipment.
CPU • Intel® Core™ i7 4770S 3.1 GHz or faster
Storage and Memory • 512 GB hard drive or greater
• 16 GB RAM or greater
Interfaces and Peripherals System Base
• 12+1 Ethernet network interfaces
• 4 USB connections or more
Module
• One Ethernet network interface
Display • LCD
• 10.6” diagonal (26.9 cm)
• 1280 x 768 resolution
• Capacitive touch screen interface
Operating System • Microsoft® Windows® 7 Embedded OS

Chapter 5: FilmArray Torch Operating Instructions
CHAPTER 5:
FILMARRAY TORCH OPERATING
INSTRUCTIONS
NOTE: Pouch preparation may vary depending on the pouch type used. Please consult
the instruction booklet for each FilmArray reagent kit for specific preparation steps.
Using the FilmArray Torch involves three main steps:
1. Adding a patient sample to the FilmArray pouch.
2. Performing a run within a FilmArray Torch Module.
3. Viewing and/or printing a report.
FilmArray Reagent Kits

FilmArray reagent kits include FilmArray pouches and all components required to run tests on the
FilmArray Torch. Components will vary based on the type of FilmArray reagent kit. Refer to the
instruction booklet or Quick Guide for specific preparation and testing procedures.
CAUTION: Do not attempt to use components from one reagent kit to prepare a different
pouch type. Components are pouch specific.
Each FilmArray pouch is labeled with:
Batch Code Serial Number

This information is both human-readable and contained in the barcode. The pouch also includes a
space to write the Sample ID or affix a Sample ID barcode.

FilmArray Test Procedure
General Precautions
BIOLOGICAL RISKS: When working with the FilmArray Torch and clinical specimens,
personnel may come in contact with contaminants or potentially infectious material.
Appropriate biohazard guidelines for working with potentially infectious samples should be
followed. Refer to the Safety Precautions section of the appropriate FilmArray reagent kit
instruction booklet for additional safety information.
It is recommended that the handling of potentially infectious samples be performed in a biologi-
cal safety cabinet or hood, or behind a protective shield. Once a sample has been added to the
FilmArray pouch, move the pouch to a separate area to perform the test.
One of the most important guidelines for a test using PCR is to avoid contamination. Some important
rules to follow are:
• Sample collection, pouch loading, and FilmArray Torch operation should each be performed in
separate locations or work areas.
• Do not leave a work area or return to a previous work area without first completing decontami-
nation procedures (i.e., washing the area and changing protective clothing and gloves).
• Prepare and load only one pouch at a time.
• Always dispose of used pouches, or pouches that have come in contact with a sample, in a bio-
hazard waste container. Change gloves after handling a used pouch.
FilmArray pouches are stored under vacuum in individually-wrapped canisters. To preserve the integ-
rity of the pouch vacuum for proper operation, be sure that a FilmArray Torch Module will be avail-
able and operational before unwrapping any pouches for loading.
Initiate Run
Refer to the Procedure section of the appropriate FilmArray reagent kit instruction booklet for step-
by-step instructions for sample and pouch preparation.
The FilmArray Torch software includes a detailed workflow that guides the operator on how to per-
form a run.
Once a pouch has been prepared for testing, follow the on-screen instructions to enter pouch and
sample information. Insert the pouch into an available FilmArray Torch Module and start the run.
The operator cannot start a run until one FilmArray Torch Module has been added to the FilmArray
Torch software. Please see the Instrument Configuration section in Chapter 2 for more information
about adding a FilmArray Torch Module. In addition, the appropriate pouch module must be installed
on the FilmArray Torch in order to start a run (see the Pouch Module section in Chapter 6).
Initiate a FilmArray Torch run by Manual Initiation or Scan Initiation.

Manual Initiation
The operator selects a specific FilmArray Torch Module from the Dashboard using the touch screen.
To initiate a run manually:
1. Select an Available Module on the Dashboard and scan the pouch barcode on the fitment
label. Then scan or manually enter the Sample ID.
NOTE: If the barcode scanner is not available or the barcode is unreadable, manually
enter the lot number and serial number printed on the pouch label.
2. Insert the pouch into the selected FilmArray Torch Module. The Module’s LED will blink blue.
Ensure that the pouch fitment label is lying flat on top of the pouch and not folded over. As the
pouch is inserted, the Module will grab onto the pouch and pull it into the chamber.
CAUTION: Do not insert sharp objects to remove a jammed pouch. In the event of a
jammed pouch, contact BioFire Diagnostics, the local bioMérieux sales representative, or an
authorized distributor for Customer Support.

Scan Initiation
The operator scans the fitment label on the pouch while the Dashboard is displayed on the touch
screen. To initiate a run by scanning:
1. Scan the pouch barcode on the fitment label. Then scan or manually enter the Sample ID.
2. Insert the pouch into any Available FilmArray Torch Module. All available Module’s LED will
blink blue. Ensure that the pouch fitment label is lying flat on top of pouch and not folded over.
As the pouch is inserted, the Module will grab onto the pouch and pull it into the chamber.
Start Run
After the pouch is correctly inserted into the FilmArray Torch Module, the LED will blink green to
indicate that the pouch has been seated but the run has not yet started. To continue the run after
Manual or Scan Initiation:
1. Select the correct pouch protocol for the pouch and sample type.
NOTE: If only one protocol is available, it will be automatically selected.
2. Enter operator username and password, then select Next.
The Next key will only become available when a correct username and password is entered.
See the Create New Operator(s) section in Chapter 6 for more information on how to create a
new operator’s username and password.
NOTE: The font color of the username and password is red until the user name is recog-
nized by the FilmArray Torch software.
3. Review run information on the screen and if correct, select Start Run.

Once the run has been started, the selected Module’s LED will turn solid green, indicating the run is
in progress. The display also changes to the Run In Progress screen and shows the steps that the
Module is currently performing and the approximate remaining run time. The operator may navigate
to the Dashboard to perform other tasks.
Abort Run
If a run needs to be stopped before it is finished, select the applicable FilmArray Torch Module from
the Dashboard. The Run In Progress screen will display the current run information; select Abort.
Any data that has been generated for the aborted run will not be available for analysis. An aborted
run cannot be restarted and the pouch must not be re-run.
NOTE: Aborting a run may take up to five minutes to complete.

Finish Run
At the end of the run, the Dashboard changes the status of the Module to Finished and the pouch is
partially ejected. To finish a run:
1. Select the Finished Module on the Dashboard to view the report.
2. Remove the pouch from the Module as shown in the diagram in the lower left corner of the dis-
play. The Module LED is solid blue indicating that the Module is ready for a new run
NOTE: Once the pouch has been removed, the report can only be viewed through the
Browse Runs feature.
View Report
When a run is finished the report can be viewed on the:
• Run In Progress screen - the run report displays once the run is complete.
• Dashboard screen - a report icon appears and the status changes to Finished. Selecting the
Module box displays the run report. Once the pouch is removed from the FilmArray Torch
Module, the status changes to Available.
• Browse Runs screen - the run reports are accessible from the table.
Refer to the instruction booklet for the appropriate FilmArray reagent kit for more details about the
information provided in the report.
Print Report
Reports will always be printed to the default printer. The FilmArray Torch software can be configured
to automatically print the report at the end of the run (see the Print Options section within Settings in
Chapter 6, FilmArray Torch software).

To print a report from a previous FilmArray pouch run:
1. Select Browse Runs in the top menu on the touch screen.
2. Use the search icon to search for runs.
3. Select a single desired run from the table.
4. Select View Report to open the report page.
NOTE: If no runs or multiple runs are selected, the View Report option is disabled.
5. Select Print.
Error Messages
If errors occur, see Chapter 8, Preventative Maintenance and Troubleshooting, for more information
on viewing and handling error messages.

Chapter 6: FilmArray Torch Software
CHAPTER 6:
FILMARRAY TORCH SOFTWARE
This chapter explains how to use the FilmArray Torch software and manage the database. The
FilmArray Torch software automatically starts when the FilmArray Torch is powered on – no login is
required.
FilmArray Torch Toolbar

The table below lists the features available in the FilmArray Torch toolbar:
FilmArray Torch Toolbar Description

The Dashboard allows the operator to do the following:
• View the status of each FilmArray Torch Module in the sys-

tem on a display that can be seen from a distance.
Dashboard
• View the status of all runs that are in progress, along with
the Sample ID, Pouch Type, and time remaining until com-
pletion.
• Start a run by using the Start Run Workflow.
Browse Runs allows the operator to review Run Results for runs
performed on all FilmArray Torch Modules within the FilmArray
Torch. The Browse Runs feature displays all the runs and allows
access to the following actions:
• View Report – This option is inactive until a specific report

is selected.
Browse Runs • Options – Allows access to additional features.

• Run Table – Allows the operator to perform the following
actions:
a. View and sort runs in the database.
b. Filter the database by run criteria.
c. Page through the runs using the paging navigation at

the bottom of the screen.
Settings Settings allows the operator to perform basic configuration and

management of the FilmArray Torch. See the Settings section for
details.

Dashboard
The Dashboard option is always accessible from the toolbar. To access the Dashboard from any
screen, select the Dashboard option on the toolbar. The FilmArray Torch Dashboard allows the
operator to interact with several FilmArray Torch Modules from one System Base. Each FilmArray
Torch Module is represented by a box displayed on the touch screen. Until at least one Module has
been added to the FilmArray Torch software, the Dashboard will be blank. The number of boxes on
the Dashboard mirrors the number of Modules that are configured.
Any FilmArray Torch Module box on the Dashboard can be selected to display additional details
about the FilmArray Torch Module status.
The details for each FilmArray Torch Module include the following:
Status Icon Status Description

The Module is available for a new run. The operator
Available
can initiate a new run (Manual Initiation of workflow)
Run In Module is performing a run and displays the Time

Progress Remaining.
Module is performing a run and has gone over
Overtime the expected run time for the pouch and displays
Overtime.
Run has finished, pouch is ejected, run report is
Finished
ready for viewing.
Module has lost connection with the software as a
result of one of the following:
Attention
• Module is initializing or is not connected.
• There is an unknown pouch in the Module.
The Module needs to be reset.
Module has an error on it as a result of one of the
following:
Attention • Pouch jam
• Stalled
• Module error

Browse Runs
The Browse Runs option is always accessible from the toolbar. To access Browse Runs from any
screen, select the Browse Runs option on the toolbar. When a run is completed on a Module,
the software generates a report with the results of the run. Upon initial entry into the Browse Runs
screen, all the runs within the database are displayed.
The runs are presented as a table that lists the date of the run, the Sample ID, and other information
about the run. Selecting an individual run enables the View Report option, which can be selected
to display the run report. For more information on viewing a report, see Chapter 5, FilmArray Torch
Operating Instructions.
View Report Menu

The table below lists the features available on the View Report menu:
Menu Item Description

Print Prints the run report. See Chapter 5, FilmArray Torch Operating
Instructions for more information about printing a report.
Save Opens a dialog that enables the operator to save the run report
to a chosen location.
Actions Allows for the following actions to be performed for the selected
report:
1. Edit Sample ID: If a mistake was made during run

setup when entering the Sample ID, the operator can
make the necessary corrections. A history is recorded
of all changes and will be added to the run report.
2. Show Run Details: Allows the operator to view sys-

tem details, messages and errors associated with a
run.
3. Create Error Bundle: If an error associated with a

FilmArray run occurs, a Customer Support represen-
tative may request that the operator create an error
bundle for that run and send it to BioFire Diagnostics.
For more information on creating an error bundle, see
the Error Bundle section in Chapter 8.

Save Report
Run reports can be saved as a PDF file for future use. To save reports as PDF file:
1. Insert a removable drive into an available USB port on the front of the System Base. One or
more removable drives, including USB flash drives, external CD/DVD drives, and external hard
drives, can be connected to the USB ports on the System Base.
NOTE: Reports can only be saved to an removable drive.
2. Select Save on the View Report page.
3. Choose location and filename; then select Save. If multiple removable drives are connected to
the USB ports on the System Base, select a destination device.
4. After save completion, select OK to close the dialog. It is now safe to remove the removable
drive(s) from the front of the System Base.
Edit Sample ID
To change the Sample ID if a mistake was made during run set up:
1. Select Actions in the View Report page; then select Edit Sample ID.
The operator is presented with a table that lists any previous change history.
2. Update the current Sample ID; then enter Username and Password.
The save option is not enabled until the operator has entered their Username and Password.
This tracks the changes to a specific user and meets the electronic signature and records
requirements required in laboratories.
3. Select Save.
After saving the changes, the report reflects the new Sample ID and displays the Change
History.
Show Run Details

To see details of the run:
1. Select Actions on the View Report page; then select Show Run Details from the menu.
The operator is presented with a list of the system details, messages, and errors associated
with that run.
Create Error Bundle

For more information on creating an Error Bundle, see the Error Bundle section in Chapter 8.

Search Run Data

Search
The search icon on the Browse Runs page contains multiple search criteria the operator can
use to locate desired runs. The following table describes the search criteria options:
Criteria How to Search
Date Select the date or date range of interest.
Sample ID Enter the Sample ID of interest.
Pouch Type Select the panel of interest.
Operator Select the operator of interest.
Module Select the Module serial number of interest.
Pouch Status Select the pouch outcome of interest: Pass, Fail or Invalid, Completed,
Incomplete, Aborted, Instrument Error, or Software Error.
To clear Search Criteria and view all of the runs saved in the database, select Clear All on the
search screen or the X on the search results page.
To retain the search criteria and update the search results to include recent runs, select Refresh.
Browse Runs Options Menu

The Browse Runs options menu presents a list of actions the operator can use on FilmArray Torch
runs. The following table describes the available Browse Runs options:
Menu Item Description

Export Runs Enables the operator to write runs to a file while leaving the original runs
in the FilmArray database.
Import Runs Enables the operator to import FilmArray runs from a separate FilmArray
database into the database on the FilmArray System Base being used.
Export Anonymous Works like the Export Runs option, but replaces the Sample ID in the run
Runs files with Anonymous.
To access the Browse Runs options menu, select Options to bring up the Options menu.

Export Runs
When exporting runs, database files are saved with the extension .db. To export runs to a file:
1. Insert removable drive(s) into an available USB port on the front of the System Base. One or
2. Select Browse Runs from the toolbar to display a list of runs in the database. Runs can be
searched and filtered by selecting the search icon . See the Search Run Data section in
this chapter for more information.
3. Select Options to view the Options menu; then select Export Runs.
4. Select one or more desired runs on the Browse Runs page; then select OK.
5. Select a location and filename for the .db file within the Specify Filename dialog. If multiple
removable drives are connected to the USB ports on the System Base, select a destination
device.
6. Select Save to start the export process. The message Exporting Runs... appears during the
exporting process.
The operator can cancel the export process before it completes by selecting Cancel on the
export process dialog. Any runs that were exported before selecting Cancel will be saved to
the chosen location.
7. After export completion, a Successfully Exported [n] Runs to File message appears. Select
OK to close the export process dialog.
It is now safe to remove the removable drive(s) from the front of the System Base.
Import Runs
When importing runs, database files with the extension .db are added.
This process can also be used to restore any archived files with the extension .faz. Prior to restor-
ing archived runs, verify that there is sufficient room in the database. If the database is approaching
5,000 runs, see the Archive Runs section in this chapter for more information.
To import runs from a file:
1. Insert the removable drive(s) containing the files into an available USB port on the front of
the System Base. If multiple removable drives are connected to the USB ports on the System
Base, select a destination device.
2. On the Browse Runs page, select Options to display the Options menu; then select Import
Runs.
The software searches the root level of all connected removable drives for any files that con-
tain run data (both .db and .faz) and displays these files on the Select File page.

3. Select the runs needing to be imported (or restored) to start the import process.
The operator can stop the import process before it completes by selecting Stop. Any runs that
were imported before selecting Stop will be saved in the database.
4. After import completion, select OK to close the dialog. It is now safe to remove the removable
drive(s) from the front of the System Base.
Export Anonymous Runs

Anonymous run files are saved with extension .adb. If a copy of run files must be sent to an external
site, this option protects patient confidentiality. To prevent operators from overwriting a run file with
an anonymous run file, these files cannot be imported back into the database
To export anonymous runs to a file:
1. Insert removable drive(s) into an available USB port on the front of the System Base.
2. Select Browse Runs from the toolbar to display a list of runs in the database. Runs can be
searched and filtered by selecting the search icon . See the Search Run Data section in
this chapter for more information.
3. Select Options to view the Options menu; then select Export Anonymous Runs.
4. Select one or more desired runs on the Browse Runs page; then select OK.
5. Select a location and filename for the .db file within the Specify Filename dialog. If multiple
removable drives are connected to the USB ports on the System Base, select a destination
device.
6. Select Save to start the export process. The message Exporting Runs... appears during the
exporting process.
The operator can cancel the export process before it completes by selecting Cancel on the
export process dialog. Any runs that were exported before selecting Cancel will be saved to
the chosen location.
7. After export completion, a Successfully Exported [n] Runs to File message appears. Select
OK to close the export process dialog.
It is now safe to remove the removable drive(s) from the front of the System Base.

Settings
The Settings option is always accessible from the toolbar. To access Settings, select the Settings
option on the toolbar. The Settings option allows users to perform the following administrative type
tasks:
• Print Options - Allows the operator to set or change a default printer as well as the option to
have reports automatically printed.
• Operators - Displays all operators currently recognized in the software and allows for addition
and modification of operators within the system.
• Pouch Modules - Displays all currently installed pouch modules within the software and allows
for installation of new pouch modules, modification of their status (active/inactive), and removal.
• Instrument Modules - Displays high level information for all Modules connected to FilmArray
Torch.
• Archive - Allows operators to archive old runs off FilmArray Torch to an removable drive.
• System Log - Allows access to system logs for all Modules.
• About FilmArray - Displays details about FilmArray Torch installation.
• Switch to Admin Mode - Allows an administrator to log out of the FilmArray Torch software and
access the Windows OS to perform administrative tasks (such as software/firmware updates,
printer maintenance, and Instrument Configuration).
• Switch to Cleaning Mode - Allows an operator to temporarily freeze the touch screen so the
surface can be cleaned without activating any actions (see Chapter 8, Preventative Maintenance
and Troubleshooting).
Print Options
Any printer that has been configured to FilmArray Torch can be selected as the default.
To set a default printer:
1. Select the Select Printer drop down box to display all printers configured to the System Base.
The current default printer is highlighted green.

2. Select the applicable printer to set it as the default.
The software updates the default printer and displays the new default within the Select Printer
display box.
To Auto Print Reports after a run, toggle the Auto Print Reports setting to On or Off.
Operators
An operator username and password are required to run a pouch on FilmArray Torch.
The FilmArray Torch software prompts the operator to enter these credentials after a pouch has
been inserted into an available Module and pouch information has been captured.
The Operators feature displays all current operators on FilmArray Torch. This feature allows for the
addition, modification, and/or deletion of operators.
Create New Operator(s)

New operators are created in two ways:
• Within the Settings toolbar Operators menu option within the Settings toolbar.
• Before starting a run during the Enter Operator Information step.
Operators menu option:
1. Select the Settings options from the toolbar; then select Operators.
2. Select Add Operator at the bottom of the screen when the list of current operators display.
3. Enter the new operator’s information in the following fields:

• First Name
• Last Name
• Username
• Password
• Confirm.
The Confirm field will always display the password dots in red until the Password and Confirm
fields match.
4. Select Save when complete.

Enter Operator Information step:
1. Select Add/Edit Operator.
2. Follow steps 3 and 4 in the previous instructions, Create New Operator(s).
Pouch Modules
This feature enables the operator to install, and inactivate/uninstall pouch modules. These pouch
modules contain definitions, protocols, analysis and reporting for specific FilmArray reagent kits.
Install Pouch Modules

When new pouch modules are received from BioFire Diagnostics, the Pouch Modules option must
be used on the FilmArray Torch. For information on receiving new pouch modules, contact Customer
Support (see page i).
To install a new pouch module:
1. Insert removable drive containing the pouch module software. One or more removable drives,
including USB flash drives, external CD/DVD drives, and external hard drives, can be con-
nected to the USB ports on the System Base.
2. Navigate to the Settings menu from the toolbar.
3. Select Pouch Modules.
All pouch modules currently installed display as Active.
4. Select Install New Pouch The software searches the root level of all connected removable
drives and displays any detected pouch modules.
5. Select Install next to the desired pouch module. The new pouch module then displays with an
Active status in the list of installed pouch modules to indicate that it is ready for use.

Inactivate/Uninstall Pouch Module

To inactivate a pouch module:
• Toggle the Active slider next to the pouch name to Inactive.
To uninstall a pouch module:
• Select Uninstall next to the pouch module name.
When a pouch module in uninstalled, it is no longer available for selection when starting a run.
To re-activate an uninstalled pouch module, it must be installed again.
Archive Runs
To archive runs stored in the FilmArray database:
1. Insert removable drive(s) into an available USB port on the front of the System Base. One or
2. Navigate to the Settings menu from the toolbar.
3. Select Archive.
The Archive Log will display the current status of archives and a log of all previous archiving
tasks.
4. Select Archive Runs to display a calendar.
5. Select a date parameter on the calendar. This parameter means that all runs on or before that
date will be archived.
If more than 100 runs are selected, archived runs are sorted into files containing 100 runs
each.

6. Select Next to choose the location and filename for the archived runs. It multiple removable
drives are connected to the USB ports on the System Base, select a destination device.
By default, runs are saved to a file with the extension .faz. Filenames default to a name con-
taining the date parameter and the name of the System Base being used.
After selecting the file name, a message displays indicating that the selected runs will be delet-
ed from the database.
7. Select Yes to launch the archiving process. The date and time of the start will be recorded in
the Archive Log.
The archive process executes in the background and the status of the archive is seen in the
status message on the Archive Log page. The operator may navigate to the Dashboard to per-
form other tasks.
NOTE: The software verifies that all runs have been saved to the file, and then deletes
each run from the database one at a time.
When the archiving is complete, the date and time of the completion is logged and the
archiving Status is set to Idle.
8. Remove the removable drive on which the .faz file was saved from the System Base and store
according to institutional data retention policies.
Abort Archive Process

It is safe to abort the archive process while runs are being saved. To abort:
• Select the Cancel status message; then select Confirm.
The status message changes to Canceling Archive. The archive stalls and all runs remain in the
database.
When archive cancellation is complete, the date and time of the completion is recorded in the
Archive Log and the archiving Status is set to Idle.
NOTE: It is not safe to abort the archiving process while runs are being removed from the
database. During this time, the software will not allow the operator to cancel the process.
CAUTION: Do not attempt to shut down the System Base or switch to Admin Mode during
the archiving process. Wait until the process is complete before shutting down the System
Base or performing other tasks.
Restore Runs
If a run file must be accessed after it has been removed from the database, the runs stored in the
.faz file can be restored to the database by using Import Runs (see the Import Runs section in this
chapter for more information).

Switch to Admin Mode

Admin Mode tasks are specific to the Windows application; these include:
• Installing printers
• Adding and removing Modules
• Updating software and applying security patches.
Please see Microsoft help for instructions on adding and deleting printers and changing the date and
time. For further assistance, please contact Customer Support (see page i).
NOTE: Do not perform administrative tasks on the System Base—including setting the
System Base’s date/time—while a run is in progress on any Module.
To access the main Windows application:
• Select Settings from the toolbar; then select Switch to Admin Mode.
This logs the user out of the FilmArray Torch software and allows for the admin user to log in to
Windows. Once logged in as the admin user, the normal Windows desktop is displayed with lim-
ited access to Windows tools and the Instrument Configuration application.
NOTE: Logging into Admin Mode requires an administrative password. The FilmArray
Torch is pre-configured with an administrative user account. The Windows user name is
“LabAdmin” and the default password is “Lab_Admin”. It is recommended that local IT per-
sonnel change the default password for the LabAdmin user account. Do not delete or modify
the groups associated with the LabAdmin user account.
Instrument Configuration
Details of instrument configuration, including how to add and remove individual FilmArray Torch
Modules, is done through Admin Mode using a separate application. Please see the Instrument
Configuration section in Chapter 2 for more information about adding a Module.
Printer Configuration
Adding and configuring printers to the FilmArray Torch is done through Admin Mode using the stan-
dard Windows features. For more information, see the Switch to Admin Mode section in this chapter.
Database Management
A local database on the System Base stores all run data generated by the FilmArray Torch. The runs
saved in the database are listed in a table within Browse Runs toolbar. For more information on the
function and use of the Browse Runs toolbar, see the Browse Runs section in this chapter.
The database stores up to 12,000 runs reliably. A warning appears when 5,000 runs is reached to
encourage frequent archiving of data. For more information on archiving runs, see the Archive Runs
section in this chapter.

Chapter 7: Precautions When Working with the FilmArray System
CHAPTER 7:
PRECAUTIONS WHEN WORKING
WITH THE FILMARRAY SYSTEM
Laboratory Safety and Biohazards
General Safety Precautions

Please note that while the FilmArray pouches and the FilmArray Torch Modules are not themselves
biohazardous, it is good laboratory procedure to handle all waste materials as potentially
biohazardous material.
a. Follow all safety instructions printed on, or attached to, the FilmArray Torch.
b. Observe all general safety precautions that apply to electrical instruments.
c. Never touch switches or power cords with wet hands.
CAUTION: Do not attempt to lift or carry the FilmArray Torch while Modules are installed.
Remove all Modules prior to lifting or carrying the FilmArray Torch System Base and always
lift from the bottom.
NOTE: Only authorized service personnel should perform service or repairs required for
this unit.
Laboratory Precautions
Handle all samples and waste materials as if they were capable of transmitting infectious agents.
Refer to Biosafety in Microbiological and Biomedical Laboratories (Centers for Disease Control and
Prevention and National Institutes of Health; available online at http://www.cdc.gov/od/ohs/biosfty/
bmbl5/bmbl5toc.htm) or other appropriate Biosafety procedures.
Observe safety guidelines found in the Clinical and Laboratory Standards Institute (CLSI) Protection
of Laboratory Workers from Occupationally Acquired Infections, Approved Guideline M29 or other
appropriate safety guidelines.
Wear personal protective equipment (PPE) and disposable powder-free gloves while handling
reagents or samples and change gloves often. Wash hands thoroughly after performing a run.
Refer to the FilmArray reagent kit instruction booklets for assay-specific safety precautions.
CAUTION: A tear in the pouch could contaminate the Module and the surrounding area.
Carefully dispose of pouches in a biohazard waste container.

General PCR Precautions

One of the most important guidelines when performing PCR is to avoid contamination. Some
important rules to follow are:
a. Perform sample collection, pouch preparation, and running the FilmArray Torch in separate
locations.
b. Load the pouch with sample behind a protective shield (or in a biological safety cabinet or
hood whenever possible).
c. Do not leave a laboratory area without first completing decontamination procedures (i.e.,
washing and changing protective clothing and gloves).
Decontamination and Cleaning Procedures

The decontamination and cleaning procedures listed are intended to limit spread of contaminants as
a result of a broken or leaked pouch. Decontamination is necessary to prevent false-positive results
in subsequent runs.
If a pouch leak or breakage occurs, change gloves and other potentially contaminated personal
protective equipment (PPE). Change gloves often during the decontamination process, especially
during the first steps of decontamination and before touching any clean surface. All PPE should be
disposed of after decontamination.
CAUTION: It is important that contamination from leaking and/or punctured pouches be

contained and cleaned immediately. Pouches that break after PCR can contaminate future
pouch runs. This material, although noninfectious, is easily spread by normal human activity.
Treat all broken pouches as capable of contaminating the work area. Very small (molecular)
quantities can be amplified by PCR in future runs, which can then be identified as a false
positive by the FilmArray Torch.
BIOLOGICAL RISKS: If the pouch contains potentially infectious material, the risk of bio-
hazard contamination exists in addition to sample contamination.
Cleaning Materials
This list provides items that are necessary in a laboratory to keep contamination to a minimum:
• 10% bleach solution in a squeeze or spray bottle (1 part bleach to 9 parts water)
• Distilled water in a squeeze or spray bottle
• DNAZap™ or equivalent DNA degrading system
• Paper towels
• Bleach wipes

Pouch Loading Station Decontamination

Routine cleaning of the Pouch Loading Station includes a 10% bleach wipe followed by two water
wipes before each new pouch is loaded.
In the event of a sample spill or pouch leak, perform the following decontamination procedures.
1. Put on clean PPE, such as lab coat and gloves.
2. Fill a sink or bin with water and add bleach to create a 10% bleach solution.
3. Submerge the Pouch Loading Station until completely covered with bleach solution. Soak for
15 minutes.
4. Remove Pouch Loading Station from sink or bin. Replace bleach solution with distilled water.
5. Rinse the Pouch Loading Station by completely submerging in distilled water two additional
times.
Contact BioFire Diagnostics, the local bioMérieux sales representative, or an authorized distributor to
obtain a replacement Pouch Loading Station, if necessary.
Decontamination Related to Pouch Leakage

If a pouch leaks, take the following precautions to avoid contamination:
1. Put on clean PPE, such as a lab coat and gloves.
2. Ensure no one uses the FilmArray Torch Module or potentially contaminated areas until the
decontamination is complete.
3. Decontaminate the FilmArray Torch Module and work area and dispose of the pouch using the
following steps:
a. Dispose leaking pouch in a biohazard container.
b. Dispose of potentially contaminated gloves and put on clean gloves.
c. Dispose of the potentially contaminated lab coat.
d. Put on clean PPE, such as a lab coat and gloves.
e. Clean the Module and affected work areas following the guidelines below in Module
Decontamination.
CAUTION: Use only 10% bleach solution, distilled water, and/or DNAZap to
decontaminate the FilmArray Torch Module and Pouch Loading Station.

FilmArray Torch Module Decontamination
2. Remove pouch from Module and dispose in biohazard waste container.
3. Dispose of potentially contaminated gloves and lab coat and put on clean gloves and lab coat.
4. Wet a paper towel with the 10% bleach solution and wipe all exterior surfaces of the FilmArray
Torch, including the bottom and the bench top where the FilmArray Torch Module had contact.
Let it stand for at least 3 minutes to allow the bleach solution to react with any contaminants.
Discard paper towel in biohazard waste. Change gloves.
NOTE: When cleaning the touch screen, put the FilmArray Torch into Cleaning Mode. The
Cleaning Mode allows 30 seconds for the touch screen to be cleaned. Access this features
from the Settings toolbar (see Chapter 8, Preventative Maintenance and Troubleshooting for
more information).
CAUTION: The interior of the pouch slot and Module(s) should not be cleaned. Do not
spray or insert any cleaning materials into the Module.
5. Repeat Step 4 twice with fresh paper towels for a total of three bleach wipes.
6. Change gloves, then wet a new paper towel with distilled water and wipe the all exterior
surfaces of the FilmArray Torch. Dispose of paper towel in biohazard waste. Change gloves.
7. Repeat Step 6 with a new paper towel.
8. Remove Module front cover. Repeat Steps 3 through 7 for inner front cover surfaces and
pouch slots.
Decontamination of Bench Tops and Other Areas
2. Spray the 10% bleach solution on the area that may have been contaminated. Let it stand
for at least three minutes to allow the bleach solution to react with any contaminants on the
surface.
3. Wipe the area with a clean paper towel. Change gloves.
4. Repeat Steps 2 and 3 twice, for a total of three wipes.
5. Change gloves. Spray the area with distilled water.
6. Wipe the area dry with a new paper towel. Change gloves.
7. Spray the area with DNAZap or an equivalent product. Follow the product’s instructions for
correct use. Change gloves.
8. Rinse the area by spraying it with distilled water and wiping it dry.

Check Function of Decontaminated FilmArray Torch Module
1. Test a negative sample by preparing a pouch according to instructions in Chapter 5, using

water as the sample. Use distilled, sterile or molecular grade water for this test.
2. If the run is successful and all results are negative, continue using the Module as normal.
3. If unexpected positive results are obtained, or the run fails, please contact BioFire Diagnostics,
the local bioMérieux sales representative, or an authorized distributor for further instructions.

Chapter 8: Preventative Maintenance and Troubleshooting
CHAPTER 8:
PREVENTATIVE MAINTENANCE
AND TROUBLESHOOTING
Introduction
This chapter provides step-by-step instructions for operators performing basic maintenance and
troubleshooting for the FilmArray Torch.
The tasks performed in this chapter are the only tasks that should be performed by the operator. Do
not attempt to perform any additional maintenance without the guidance and direction of a specialist
from BioFire Diagnostics, the local bioMérieux sales representative, or an authorized distributor.
In the event that an individual Module or the entire FilmArray Torch is taken out of service, follow the
FilmArray Torch Return Procedure in Appendix A.
General Maintenance
There is no general maintenance needed for the FilmArray Torch other than the periodic cleaning
steps listed below:
1. Wipe down all outside surfaces of the FilmArray Torch with a cloth or paper towel and a freshly
prepared 10% bleach solution (one part bleach to nine parts water), followed by a water wipe.
NOTE: Do not remove the Module front cover and clean underneath it, except in the case
of a contamination event.
2. Periodically check and clean the FilmArray Torch Module’s air filters for any build up and
debris. Air filters can also be swapped out with the spare filters included with the FilmArray
Torch Module box (see Chapter 2, FilmArray Torch Setup).
3. When cleaning the touch screen of the FilmArray Torch, it is recommended that the FilmArray
Torch software be put into cleaning mode in order to avoid any accidental selections.
This can be done by navigating to the Settings toolbar and selecting the Switch to Cleaning
Mode option. After selecting a confirmation for this action, the screen will display a timer for 30
seconds that will temporarily freeze the screen and allow for cleaning of the surface.

System Base Shutdown

It is not necessary to shut down and restart the System Base. If facility policy requires regular shut-
down, select the reset button on the back of the System Base, wait for the screen to go black, then
switch off the power. Switching the power back on will then restart the System Base and start the
software automatically.
System Base Reset System Base On/Off Switch
Troubleshooting
Pouch Troubleshooting
For problems encountered while using a FilmArray pouch, see the possible solutions below. If pouch
leakage occurs, refer to Chapter 7 for proper decontamination procedures.
Problem Possible Error Cause Solution
Pouch packaging is not sealed Loss of vacuum in pouch Attempt to hydrate. If pouch
tightly around pouch canister packaging hydration is successful, con-
tinue the run. Otherwise, dis-
card the pouch and use a new
pouch to test the sample.
Pouch does not automatically Loss of vacuum in pouch Discard the pouch and use a
draw Hydration Solution or new pouch to test the sample.
sample mix into pouch when
loading
Failed controls Hydration Solution not added Retest sample in a new
or drawn into pouch pouch.
Sample mix not added or Retest sample in a new
drawn into pouch pouch.
pouch and/or FilmArray Torch Retest sample in a new
Module are not functioning pouch.
properly If controls continue to fail con-
tact Customer Support.
Inadequate volume in Hydra- Evaporation or leakage Discard vials/ampoules and
tion Solution or Sample Buffer obtain new ones.
vials/ampoules

Warning Messages
Warning Messages may originate in a FilmArray Torch Module, in the software, or in communication
between the two. These messages and the suggested actions are reported in the table that follows.
Warning Message Possible Solution

The pouch has already been run - a pouch can Dispose of any pouch that has already been
only be used once. run in a FilmArray Torch Module.
An attempt to leave the workflow has been Select Yes to end the workflow. If a pouch has
made. If a pouch has been inserted the pouch been inserted, it will eject from the Module.
will be ejected and Run Setup will have to be
restarted. Do you wish to continue? The ejected pouch may be used to begin
another workflow.
FilmArray Torch database has more than 5,000 Use the Archive Runs feature in the Settings
runs on it. Please use the Archive feature with- tab to remove run files from the database.
in Settings to remove runs from the database
and store them according to your data retention Contact Customer Support if the problem per-
policy. sists.
Please contact FilmArray Customer Support if

you require assistance.
Auto Print Error. There is an error auto print- The FilmArray Torch software could not find
ing reports. See the System Log for details of the default printer. Ensure printer is properly
affected runs. connected. Use Print Options on the Settings
Printer Error. The report could not be printed toolbar to select a new default printer or Admin
Mode to add a new default printer. For more
information see Chapter 6.
Hardware Troubleshooting
The table below lists potential symptoms and possible solutions for troubleshooting hardware issues
with the FilmArray Torch. If the issue(s) persists after applying the recommended solutions, contact
Customer Support for further assistance (see page i).
Symptom Possible Solution

FilmArray Torch Module status • Turn Module on
lights are not on • Check power cord
• Try different outlet
• If problem persists, contact Customer Support
FilmArray Torch Module status • Reset system using the reset button located on the rear
light is red of the System Base
• Check and reconnect cables
FilmArray Torch Module status • Remove and discard the pouch
light is blinking purple • Remove the front cover of the affected Module and reset
the Module
Software will not connect to • Check cable connections
FilmArray Torch Module • Turn off system and disconnect all cables
• Reconnect all cables and turn system on

Symptom Possible Solution

Pouch not recognized when • Remove the front cover of the affected Module and reset
inserted into or removed from the Module
FilmArray Torch Module • If problem persists, contact Customer Support
Pouch not recognized when • Follow the software’s on-screen instructions for recovery
inserted into FilmArray Torch • If problem persists, contact Customer Support
Module, due to jam
Pouch is ejected immediately after • Remove the front cover of the affected Module and reset
insertion the Module
• Check and reconnect cables
Pouch is difficult to insert into • Remove the front cover of the affected Module and reset
FilmArray Torch Module the Module
Pouch does not eject from Module • Remove the front cover of the affected Module and reset
after run the Module
Software on the System Base • Reset the System Base using the reset button on the
crashes back of the System Base.
Barcode will not scan • Manually input the pouch serial number and lot number
Module Reset
If a Module needs to be reset, remove the magnetic front cover; then press and hold the Reset but-
ton until the light turns off.
Error Messages
Errors in the FilmArray Torch may originate in a Module, in the software, or in communication
between the two. In each case, the software reports a clear message with instructions that the oper-
ator can follow to resolve the issue. These messages and the suggested actions are reported in the
table that follows.
The FilmArray Torch performs self-diagnostics with every run. Malfunctions are reported as errors
to the operator with instructions on how to correct them. Record any error messages to assist in
troubleshooting. Questions should be directed to BioFire Diagnostics, the local bioMérieux sales rep-
resentative, or an authorized distributor.
If communication is lost between the Module and System Base during a run, the run will continue
and data will be uploaded when communication is re-established.

Error Message Possible Solution

Remove the magnetic front cover from the Follow the error message as directed.
Module and press the Reset button. Contact Customer Support if the problem
persists.
A white light on the Module indicates initialization
which may take up to 2 minutes. If the problem
persists, contact FilmArray Customer Support for
assistance.
The FilmArray Torch encountered an error during Discard the pouch and follow the error mes-
the run. The test results are invalid. sage as directed.
Please see the System Log for details. If the The message should be accompanied by
problem persists, contact FilmArray Customer a fast blinking green light on the Module.
Support for assistance. The light indicates that the pouch can be
removed. Removing the pouch sets the
Module into an Available state. Contact
Customer Support if the problem persists.
Data Recovered. Data has been recovered from
a FilmArray Torch Module that could not be pro-
cessed.
Please see the System Log for details.

Please contact Customer Support for assistance. Follow the error message as directed.
Run data was retrieved but cannot be analyzed Contact Customer Support if the problem
because the <pouch type> pouch module was persists.
not installed in the software.
For assistance, please contact FilmArray

Customer Support.
The software for the scanned pouch is not Verify the correct pouch module is installed
installed or is inactive. Please install or activate and the correct barcode has been scanned
the required pouch module. for the pouch.
Diagnostic Errors
Diagnostic errors are used by Customer Support representatives to troubleshoot FilmArray Torch
problems. See the System Log section in this chapter for details on accessing diagnostic error infor-
mation.
The table that follows lists potential error messages and possible solutions. If the error(s) persists
after applying the recommended solutions, contact Customer Support for further assistance. Before
contacting Customer Support, write down all error messages, the serial numbers of the System
Base, affected Module(s), and pouch lot numbers. Customer Support will use this information to
identify and resolve the error(s).

Error Message Possible Solution

1012 Pouch Not Present • Remove the magnetic front
1014 Failed to Find Run Data cover and press and hold the
Reset button until the light turns
1015 Failed to Read Run Data
off.
2003 Thermoboard is not present • A white light on the Module
2004 Valve board is not present indicates initialization which may
3001 Valve Board Response Timeout take up to 2 minutes.
• If the problem continues, please
contact Customer Support for
assistance.
3002 Valve Board Malformed Response • Remove the magnetic front
3003 Valve Board Command Error Response cover and press and hold the
Reset button until the light turns
3004 Thermocycler Board Response Timeout
off.
3005 Thermocycler Board Malformed Response • A white light on the Module
3006 Thermocycler Board Command Error Response indicates initialization which may
4001 Pressurization failed take up to 2 minutes.
• If the problem continues, please
7001 Camera Initialization Error contact Customer Support for
7003 Failed Excitation Check assistance.
Error Reporting Tools
System Log
The error messages may refer to the System Log for details depending on the error and is accessed
via the Settings option. When the System Log is opened, the following displays. Select the plus icon
to view additional information regarding the error.

Error Bundle
A Customer Support representative may request the operator to create and provide an error bundle
to assist in troubleshooting.
To create an error bundle:
1. Insert a removable drive into a USB port located on the front of the System Base.
2. Select the Browse Runs option from the toolbar.
3. Select the desired run.
4. Select View Report to open the report page; then select Actions.
5. Select Create Error Bundle menu item. A dialog displays the drive path and file name.
6. Navigate to a file location to save the zipped error bundle.
7. Select Save.
8. When the error bundle is complete, a message will indicate that the error bundle has been
created.
9. Remove the removable drive.
10. Email this file to the Customer Support representitive to diagnose errors.

Appendix A: FilmArray Support Information
APPENDIX A:
FILMARRAY SUPPORT
INFORMATION
FilmArray Torch Module problems may be reported by contacting BioFire Diagnostics Customer
Support, the local bioMérieux sales representative, or an authorized distributor.
FilmArray Torch Module Return Procedure

If returning a FilmArray Torch Module from within the United States, visit the Return Forms and
Decontamination Procedures webpage:
• http://www.biofiredx.com/support/return-forms/
If returning a FilmArray Torch Module from outside the United States, contact the local bioMérieux
sales representative or an authorized distributor for detailed instructions.
Disposal Recommendation
Components of the FilmArray Torch such as the FilmArray Torch Module, the FilmArray Torch
System Base, etc., which are marked with the crossed-out wheeled bin symbol are covered by
the European Directive 2012/19/EU.
These items must be disposed of via designated collection facilities appointed by government or
local authorities.
For more information about disposal of old product, please contact local city office or waste disposal
service; or BioFire Diagnostics Customer Support Department, a local bioMérieux sales representa-
tive, or an authorized distributor.
FilmArray Ordering Instructions

Customers inside the United States should contact BioFire Diagnostics to order any FilmArray equip-
ment, accessories, and/or supplies.
BioFire Diagnostics accepts purchase orders and credit cards (Visa®, MasterCard®, and American
Express®) as methods of payment.
Orders can be made via:
• E-mail: [email protected]
• Fax: 801-588-0507
• Phone: 800-735-6544 or 801-736-6354
• Payment is by credit card only for phone orders.
If ordering from outside the United States, contact the local bioMérieux sales representative or an
authorized distributor for detailed instructions.

Appendix A: FilmArray Support Information
Warranty Information
Product warranty information is available online at:
• http://www.biofiredx.com/support/
For warranty information for customers outside the United States, contact the local bioMérieux sales
representative or an authorized distributor.

Appendix B: Barcode Calibration
APPENDIX B:
BARCODE CALIBRATION
If the barcode scanner is not functioning, calibrate it by scanning the barcode shown below to pro-
gram the barcode scanner. The scanner should sound as the code is scanned.

For additional information regarding our products
and applications, please contact BioFire Diagnostics
Customer Support Department, local bioMérieux sales
representative or an authorized distributor.

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