FLM2-PRT-0230 FilmArray Link Software for FilmArray 2 0 User Guide
FLM2-PRT-0230 FilmArray Link Software for FilmArray 2 0 User Guide
for the
BioFire® FilmArray® 2.0 System
User Guide
BIOFIRE® FILMARRAY® LINK SOFTWARE FOR THE BIOFIRE® FILMARRAY® 2.0 SYSTEM 2
Purpose of the Document
The purpose of this document is to provide instructions for obtaining, installing or upgrading, and
configuring the BioFire Link Software on a BioFire 2.0 System. This document also provides instructions
for using and troubleshooting the software.
System Overview
The BioFire 2.0 System is an automated in vitro diagnostic (IVD) device intended for use with FDA-
cleared or approved IVD BioFire® FilmArray® Panels. The BioFire 2.0 System is intended for use in
combination with assay-specific reagent pouches to detect multiple nucleic acid targets contained in
clinical specimens. The BioFire 2.0 Instrument interacts with the reagent pouch to both purify nucleic
acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The
resulting PCR products are evaluated using DNA melting analysis. The BioFire® FilmArray® Software
automatically determines the results and provides a test report.
The BioFire 2.0 System is composed of one to eight BioFire 2.0 Instruments connected to a computer
running BioFire Software. The BioFire Software controls the function of each instrument and collects,
analyzes, and stores data generated by each instrument.
Refer to the BioFire® FilmArray® 2.0 Operator’s Manual for more information on the system.
Interface Overview
As an add-on to the system, the BioFire Link Software provides the BioFire 2.0 System with the capability
of interfacing with a data manager (i.e., a laboratory information system or middleware) to transfer test
results. There are two supported implementations: 1) a unidirectional, flat-file transfer from the BioFire 2.0
System to a data manager, and 2) a unidirectional transfer of structured text from the BioFire 2.0 System
to a data manager.
Preparation
Prior to beginning the process of interfacing a BioFire 2.0 System, the following steps must be completed.
1. Review the BioFire® FilmArray® 2.0/Torch Interface Checklist and complete steps 1 and 2 of the
checklist.
2. Ensure that no runs are in progress. The software installation and interface setup must NOT be
performed while clinical testing is in progress.
3. Remove any pouches from all the instruments and close the instrument lids.
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2. Enter the KEY-CODE “ITILIS20” and select Search.
3. Ensure that the current version is highlighted in yellow and select English below.
Note: The figure is for illustrative purposes and the current version number may change.
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4. Enter the code displayed on the screen and select Download Zip.
Note: A high-speed Internet connection is recommended for downloading the installation file.
6. Extract (unzip) the folder and save the contents on a removable drive.
7. Confirm that the following files are saved on the removable drive:
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Installing the BioFire Link Software
The BioFire Link Software v2.2 and a protocol must be installed in order to interface the BioFire 2.0
System with a data manager. Sections 4 and 5 of this document must be completed before proceeding.
IMPORTANT: The BioFire® Software v2.1 must be installed on the BioFire 2.0 System prior to installing
the BioFire Link Software v2.2 and a protocol.
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2. Confirm that the full version is 2.1.336.0. If this version is installed, close the dialog and the
BioFire® Software application and proceed to section 6.2. If this version is not installed, the
BioFire Software must be upgraded before proceeding. Contact BioFire Diagnostics Technical
Support for assistance.
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6.2. Install the BioFire Link Software v2.2
1. Insert the removable drive containing the installation file into the computer.
3. Double-click on the file named FilmArray Link Setup.exe to launch the BioFire® FilmArray® Link
installer.
Note: A prompt requesting administrative login credentials is displayed. Enter the credentials
associated with the LabAdmin user account. Refer to the BioFire® FilmArray® 2.0 Operator’s
Manual for more information.
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4. Select Install. The installer dialog window indicates when the software has been successfully
installed.
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6.3. Install a Protocol
Before proceeding, determine which protocol is required to interface and install it using the instructions
provided below. Refer to step 2 in the BioFire® FilmArray® 2.0/ Torch Interface Checklist for assistance in
determining which protocol to use. Sections 4 through 6.2 of this document must be completed before
proceeding.
Note: The screenshots below demonstrate the process of installing the FTP Server protocol and are
intended to be used for illustrative purposes. The process of installing other protocols is similar.
1. If the BioFire® Software application is not already open, start the application by double-clicking the
FilmArray icon on the desktop.
2. From the FilmArray Link tab, select the Protocol Installation option.
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3. Select the Install option associated with the protocol to be installed.
4. Select OK to close the Protocol Installed dialog. The protocol is installed and the BioFire®
Software application restarts.
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6.4. Replace a Protocol
If an installed protocol must be replaced with a different protocol, complete the following instructions.
3. Select OK to close the Protocol Installed dialog. The protocol is installed and the BioFire®
Software application restarts.
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Configuring the BioFire Link Software
In the BioFire Link Software, there are two ways to configure a protocol: 1) a new configuration can be
created or 2) a previously exported configuration can be imported.
Note: Only one protocol can be installed at any given time and only one configuration can be active at
once.
IMPORTANT: Before proceeding, ensure the following tasks have been completed:
• The FilmArray driver has been installed in the data manager and configured.
• The corresponding protocol has been installed according to the steps in section 6.3
• Protocol-specific requirements:
o FTP:
Configuring the FTP server on the BioFire 2.0 System Computer requires
creating an FTP user account. The FTP user account information will be entered
in the data manager’s FTP client. Configuration of BioFire® FilmArray® Link
requires that the user creates an account name, login, and password. Ensure this
information is available.
o HTTP:
Obtain the server URL for the data manager and ensure it is active.
Note: A secure server URL may be used to configure the HTTP protocol.
o Local Folder:
Designate the folder path on the BioFire 2.0 System Computer to which the XML
files will be sent.
Ensure the driver is configured to access the XML files in the designated folder
path.
o LIS Shared Folder:
Designate the LIS folder path to which the XML files will be sent.
Ensure that credentials for a user account with read and write access to the LIS
shared folder path and the domain (if required) are available.
Ensure the driver is configured to access the XML files in the designated folder
path.
o Network Shared Folder:
Designate the network folder path to which the XML files will be sent.
Network domain name and user account credentials with read and write access
to the network shared folder path are required. Ensure that these credentials and
the domain name are available.
Ensure the driver is configured to access the XML files in the designated folder
path.
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7.1. Configure a BioFire Link Protocol
Complete the steps in this section to configure a BioFire Link protocol.
2. Fill in the protocol credentials and select Configure. The examples shown below are for
illustrative purposes and cover each of the six protocols.
FTP
Note: The default account name is “FilmArray” but it can be changed.
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HTTP
HTTPS
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LIS Shared Folder
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3. Select OK.
Note: The FTP Server protocol is shown in the figure below but the dialog associated with the
other protocols will look similar.
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7.2. Import a Configuration
Importing allows the user to import a previous protocol configuration. Some situations where importing a
previous configuration are: software upgrade, new system install, etc. Complete the following steps to
import a saved configuration. Note that the FTP protocol is used in this example, however, the other
protocols work similarly.
2. Select Import.
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3. In the Select Configuration File to Import dialog, navigate to the configuration file. Select the file
and select Open. A dialog confirming the import is displayed.
Note: The imported configuration file contains all of the previous configuration except for the
password.
Note: If the BioFire Link Software was upgraded from version 2.0 to version 2.2 and version 2.0
was configured, a configuration file is saved in
C:\ProgramData\BioFireDx\FilmArrayLink\ConfigurationExport. The file may also be saved in a
location designated in a previous configuration export.
Note: If there is text in any of the fields of the Configure FTP Server dialog, a dialog confirming
the import is displayed when the Open is selected. Select Yes.
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4. Enter and confirm the password associated with the user account. Select the Configure option.
Note: The entries shown in the figure below are for illustrative purposes.
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Using the BioFire Link Software
This section describes how to use the BioFire Link Software. The BioFire Link Software can be accessed
from the FilmArray Link tab in the BioFire® Software v2.2 interface. From the FilmArray Link tab, operators
can:
• Access other features of the BioFire Link Software, including electronic report modules, protocols
and protocol configuration, and the FilmArray Link Diagnostic Report.
Note: The interface between the BioFire 2.0 System and the data manager must be set up before test
results can be sent. Refer to sections 6.3 for protocol installation and section 7 for protocol configuration
in this document.
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8.1. View the Status of BioFire Link Software
The Information section of the FilmArray Link tab displays the status of the BioFire Link Software.
The status of the BioFire Link Software is either Ok, Not Configured, or Error. The following table provides
a description of each status.
Status Description
Ok The BioFire Link Software is configured and the connection with the data
manager is established.
Not Configured The BioFire Link Software is not configured and there is no connection
with the data manager. Refer to section 7 of this document for more
information.
Error The BioFire Link Software has detected a connection error which
interrupts communication between the software and the data manager.
Refer to section 9 of this document for more information.
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8.2. Send Runs to a Data Manager
The BioFire Link Software allows runs to be sent to a data manager automatically or manually. The
following sections provide instructions for activating and deactivating automated run processing, as well
as for manually sending test results.
Note: When the BioFire Link Software is initially installed, automated run processing is inactive.
Note: The BioFire Link Software will only send runs with a pouch result of Pass and a status of
Completed.
When automated run processing is enabled, newly completed runs and runs completed within the last two
hours of enabling automated run processing will be formatted as XML files and the files will be sent to the
data manager within two minutes.
Runs completed more than two hours prior to enabling automated run processing must be manually
processed. Runs can be manually processed when automated run processing is active.
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8.2.2. Manual Run Processing
Complete the following steps to manually send one or more FilmArray runs.
1. From the Browse Runs tab, select one or more runs to be sent to the data manager.
2. Right-click on the run(s) to activate the context menu and select the Send to LIS option.
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3. When the runs have been sent, select Close to close the dialog.
• Transfer of a FilmArray run to the data manager (e.g., successful and failed transfers)
• Installation of a protocol
Events are presented in a scrollable table that lists the date of the event, the type of event, and the
message details. They can be sorted by date and type.
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8.4. Access Additional Features of the BioFire Link Software
The Options section of the FilmArray Link tab provides the operator with a menu that lists other features
of the software. The features are described in the table below.
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Menu Item Purpose
FilmArray Link Diagnostic Report Enables the operator to access a report to assist with
troubleshooting the BioFire Link Software and the network
connection with the data manager.
Electronic Report Modules Enables the operator to install and manage electronic report
modules.
Selecting the FilmArray Link Diagnostic Report option will generate and display a report. When
generating the report, the BioFire Link Software performs tests to determine if there are any issues with
the BioFire Link Software, network connection, or the interface. The results of the tests are shown in the
report when it is generated. If a test failed, more information is provided by selecting the Details option
associated with the test.
Once a report is generated, the operator can refresh the report by selecting the Refresh Report option.
A report can also be saved by selecting the Save Report option. It can then be sent to BioFire
Diagnostics Technical Support to assist with troubleshooting.
Refer to section 9 for instructions about how to use the report to assist with troubleshooting.
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Select the Close option to return to the FilmArray Link tab.
A panel-specific electronic report module must be installed to process and send test results for a
corresponding panel to a data manager.
1. Select the Electronic Report Modules option from the Options section of the FilmArray Link tab.
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2. Select the Uninstall option associated with the electronic report module to be uninstalled.
3. Select Yes to confirm that the electronic report module will be uninstalled.
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4. Select Close to close the Electronic Report Modules dialog.
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8.4.3.2. Export a Configuration
The Export feature allows the user to export a protocol configuration. Complete the following steps to
export a configuration.
Note: The following steps describe how to export a local folder protocol configuration but they can be
completed for any FilmArray Link protocol. If a configuration requires a password, the password will not
be included as part of the exported configuration.
1. Select the Protocol Configuration option from the Options section of the FilmArray Link tab.
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2. In the Configure Local Folder dialog, select the Export option.
3. From the Export Configuration File dialog, navigate to the location to which the configuration
should be saved and click Save.
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4. Click OK to close the status message dialog.
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Troubleshooting
If there are any issues with the BioFire Link Software or the interface between the BioFire 2.0 System and
the data manager, refer to FilmArray Link Diagnostic Report. The report can be accessed from the
Options section of the FilmArray Link tab. Refer to section 8.4.1 for more information.
The following table describes the tests the BioFire Link Software performs and displays on the FilmArray
Link Diagnostic Report. It also provides troubleshooting steps that can be used to resolve the issue.
Protocol Tests that a protocol is installed. If the test failed, a protocol must be installed.
Installed Complete the steps in section 6.3. If the issue
persists, save the report and contact BioFire
Diagnostics Technical Support.
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Test Description Action
FTP Service Tests that the FTP server If the test failed:
Running service is running. 1. Restart the BioFire 2.0 System Computer.
(FTP Server 2. Regenerate the report. If the issue persists,
Protocol only) proceed to the next step.
3. Reconfigure the FTP Server Protocol using
the credentials previously used to configure
the software. Refer to the instructions in
section 7.1.
4. Regenerate the report.
5. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
FTP Site Tests that the FTP server site If the test failed:
Configured has been created. 1. Reconfigure the FTP Server Protocol using
(FTP Server the credentials previously used to configure
Protocol only) the software. Refer to the instructions in
section 7.1.
2. Regenerate the report.
3. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
FTP User Tests that the FTP user has If the test failed:
Configured been created. 1. Reconfigure the FTP Server Protocol using
(FTP Server the credentials previously used to configure
Protocol only) the software. Refer to the instructions in
section 7.1.
2. Regenerate the report.
3. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
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Test Description Action
HTTP Server Tests that the HTTP server is If the test failed:
Responding responding. 1. Verify that the BioFire 2.0 System is
(HTTP only) connected to the network via Ethernet
cable.
2. Regenerate the report.
3. If the test failed again, contact LIS Support
personnel to verify that the data manager
HTTP server is running and accepting
POST requests.
4. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
LIS Host Tests that the LIS shared folder If the test failed:
Available host is present. 1. Verify that the BioFire 2.0 System is
(LIS Shared connected to the network via Ethernet
Folder cable.
Protocol only) 2. Regenerate the report.
3. If the issue persists, reconfigure the LIS
Shared Folder Protocol using the
credentials previously used to configure the
software. Refer to the instructions in section
7.1.
4. Regenerate the report.
5. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
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Test Description Action
LIS Shared Tests that the BioFire Link If the test failed:
Folder Software has read and write 1. Verify that the BioFire System is connected
Permissions access to the LIS shared folder. to the network via Ethernet cable.
Valid 2. With assistance from LIS Support
(LIS Shared personnel, verify that the shared folder has
Folder read and write access for the provided
Protocol only) credentials.
3. Regenerate the report.
4. If the issue persists, reconfigure the LIS
Shared Folder Protocol using the
credentials previously used to configure the
software. Refer to the instructions in 7.1.
5. Regenerate the report.
6. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
Local Folder Tests that the BioFire Link If the test failed:
Permissions Software has read and write 1. With assistance from LIS Support
Valid access to the folder. personnel, verify that the local folder has
(Local Folder read and write access for the FilmArray user
Protocol only) account.
2. Regenerate the report.
3. If the issue persists, save the report and
contact BioFire Diagnostics Technical
Support.
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Test Description Action
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