Quick Start Guide T16-ISO DESKTOP SOFTWARE - TwistDx

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1 Quick Start Guide T16-ISO DESKTOP SOFTWARE In association with E: support[email protected] W:www.axxin.com D004829 Version 1.1

2 Australian Office USA Office UK Office Ground Floor, 4370 La Jolla Village 45 King William Street 582 Heidelberg Rd, Drive, London, United Kingdom Fairfield, 3078 Suite 400 EC4R 9AN Victoria, Australia San Diego, CA, 92122 T + 44 203 714 5650 T + 61 3 9329 1167 USA F + 61 3 8732 0310 T + 1 858 736 9160 www.axxin.com ABN 43 120 905 839 F + 1 858 346 9300 DOCUMENT CONTROL DETAILS TITLE QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform DOC No. D004829 CUSTOMER CONTACT General Release DOCUMENT APPROVAL POSITION NAME SIGNATURE DATE Director of Technology Bill Hopper CEO Andrew Lysikatos REVISION HISTORY NO. REVISION DESCRIPTION AUTHOR DATE 1.1 Internal Review WRH 29 January 2016 1 First Release CCH 02 December 2013 NOTE: latest revision is first D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 2 of 14

3 Contents 1 Introduction .......................................................................................................................................................... 4 1.1 Operating Modes....................................................................................................................................... 4 2 Desktop Software Installation ............................................................................................................................... 5 2.1 Desktop Application Installer ..................................................................................................................... 5 2.2 Install Bonjour ........................................................................................................................................... 6 2.3 Customisation Tool ................................................................................................................................... 6 3 Starting the Desktop Software .............................................................................................................................. 7 3.1 Software Menu Structure .......................................................................................................................... 7 3.2 Creating a Test Type................................................................................................................................. 8 3.3 Running a Test Type on Existing Saved Data ........................................................................................... 9 3.4 Exporting a Test Package ......................................................................................................................... 9 4 Connect Desktop Application to Instrument ....................................................................................................... 10 4.1 Instrument Modes ................................................................................................................................... 10 4.2 Instrument Setup ..................................................................................................................................... 11 4.3 Connect Via USB .................................................................................................................................... 12 4.4 Connect Via Network .............................................................................................................................. 13 3 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

4 1 Introduction This document describes setup, configuration and operation of the desktop software used to operate the T16-ISO Isothermal Test Instrument with a connected PC. Axxins advanced T16-ISO isothermal instrument provides next generation molecular testing in a compact, stand alone, high sensitivity instrument suitable for both laboratory and field-based applications. The T16-ISO Instrument is a portable instrument that provides measurement of three fluorophores: FAM, HEX and ROX or other fluorophores with similar spectra. This instrument is intended for research and development use only and is not intended for in vitro diagnostic (IVD) medical use without further assay and application specific, testing and certification. The T16-ISO instrument forms part of a larger test system including the chemistry assay under test and risks for the overall system should be considered. If the intended use carries risks of loss or injury, additional tests or indicators must be considered to mitigate these risks. This document is a quick guide to assist with instrument setup and use. Refer to the following full user manuals for detailed instructions and warnings: D003643 User Manual, Instrument Stand Alone Mode, Axxin T16-ISO D003374 User Manual, Instrument and Desktop Application, Axxin T16-ISO 1.1 Operating Modes The T16-ISO instrument will operate; either stand alone or connected to a desktop software application. Functions available include the ability to, run tests, observe tests and test results curves in real time. The desktop software will also allow the user to develop test types including development of customised decision algorithms. Test types can be run dynamically on the instrument, or run with previously acquired tests to optimise their functions. Test types can also be exported in a test package and imported on to an instrument for standalone testing without a connected PC. D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 4 of 14

5 2 Desktop Software Installation Obtain a copy of the installation files for the desk top software. This is obtained by USB key copy from the supplier or downloaded from the Axxin Download Centre www.axxin.com Select < support option> Then It is required to register and receive approval to get access to the downloads. This registration will give you access to all of the software modules and support documents required. 2.1 Desktop Application Installer The Desktop software can be installed on a PC running: Windows 7, Windows 8, or windows 10 The software will run under 32 bit or 64 bit operation systems. To install the software: Run T16-ISO-Desktop_installer_v1.5.0.2.exe file on the target computer. If required, give permission for application to Run. Follow prompts in the Setup Wizard Select Installation folder location (default location: C:\Program Files\Axxin\Axxin T16 ISO Desktop\ Axxin suggests the application be made available for all users on the computer. Confirm installation process. Read and accept License Agreement In pop-up window, select Customisation Profile to apply (Default Axxin T16 Customisation Profile file is included in Installer Folder). The T16-ISO Desktop application will be found in the Start Menu > All Programs > Axxin > T16-ISO Desktop. 5 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

6 2.2 Install Bonjour Select icon from the Installer Folder. The Bonjour service is a prerequisite to the Desktop application. This needs to be installed once only, and is also found in the installer directory. Recommended Install Procedure: Run BonjourPSSetup.exe Give Permission for application to Run. Follow prompts in the Bonjour Print Service Installer Read and Accept License Agreement Read the Bonjour Print Service Information Run install process 2.3 Customisation Tool The customisation tool is a special application not required for normal use refer to the full user manual for details. D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 6 of 14

7 3 Starting the Desktop Software To start the T16-ISO software select the desktop start icon or the .exe file in the T16-ISO program folder. Once started the software displays a home screen with a menu bar and icons specific to each screen. 3.1 Software Menu Structure OPEN CREATE CREATE INSTRUMENT ABOUT TEST ALGORITHM INFO PRINT TYPE SAVE AS IMPORT EDIT TEST EDIT TEST SELF TEST NEW TEST TYPE ALGORITHM EXPORT PRINT PARK OPTICS USER CLONE CLONE MANUAL EXPORT SET TEMP NORMALISE EXPORT TEMP TEST PACKAGE 7 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

8 3.2 Creating a Test Type The Test setup is conducted under the Test Types tab where test parameters can be set. It enables a user to add and remove a test profile or to edit an existing test profile. A user can view and clone a test profile. The user can clone a profile but must enter a new unique name for the new profile. Test Parameters include: Selecting tubes to use (read) in a test. It can be any combination of 1-16 tubes Selecting channels to read (e.g. FAM, HEX and ROX) Selecting LED Settings Setting Chanel LED levels (as a percent) Setting test duration Selecting a Decision algorithm, decision algorithms re created in the "Algorithms" Tab. Setting test temperature Building up workflow modules (up to 5 can be set) The test workflow is set up using a drag and drop input method. Each workflow step is configurable: o Pause: Set wait time 10-1200 seconds (20 minutes max) when T16-ISO device is at temperature; User Interface Message text required to save test type profile. o Read: Set read time 50-3600 seconds (60 minutes max) o Lid Action: Test proceeds when lid close action is recorded; set timeout 15-1200 seconds; User Interface Message text required to save test type profile. D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 8 of 14

9 3.3 Running a Test Type on Existing Saved Data To run a test, select a previously created Test Type (with associated decision algorithm) from a drop down list and select OK The tube diagram on the screen will display in which locations tubes need to be inserted. Enter a: User Name The Lot ID of the test batch Then enter the Sample ID for the tubes undergoing test. The T16-ISO will continue to heat up until the device is at temperature for testing. The Start Workflow button located at the bottom of the screen will be disabled until the device is ready. Close Lid: The device lid is required to be closed to initiate the start of a test. All Tubes: Depending on the number of tubes under test the results will be displayed in either a 16 tube or an eight tube format. 3.4 Exporting a Test Package If a comprehensive list of Test Types and Decision Algorithms has been generated on an installed version of the T16-ISO Desktop Application then that list may be configured and exported for use in other installed version of the T16-ISO Desktop application or can be imported onto a T16-ISO device to operate in standalone mode. 1. Select the test types from a list of Test types that you would like to export. 2. Select Export 3. Choose a directory to save the Test Types (*.tar) file. 4. Enter a file name. 5. Select Save 9 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

10 4 Connect Desktop Application to Instrument After installation, open the T16-ISO Desktop application. Select the connect button and view a list of detected Axxin Instruments connected over the network. The T16-ISO Desktop application will automatically find and display all supported Axxin T16 instruments. The connection between the Axxin instrument and computer is established by USB or Ethernet network over TCP/IP protocol. 4.1 Instrument Modes Stand-alone mode: allows the instrument to run independently with the use of its touch screen. There is no need for a network or computer in this mode. Remote Connection mode: allows a computer with T16-ISO Desktop installed to control the instrument and obtain data from it. To allow remote connection navigate to the Instrument GUI Remote Mode Screen (Home > Settings > Remote Mode). NOTE 1. Remote mode does not allow the user to operate T16-ISO instrument independently. D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 10 of 14

11 4.2 Instrument Setup Place the T16-ISO instrument on a stable, level bench, in a clean office or lab type environment. Configure the power supply for your region. Connect the 12V power supply to the instrument and press the front panel button to start up. Refer to the instrument user manual D003374 User Manual, Instrument and Desktop Application, Axxin T16-ISO for important warnings. Remote Mode The instrument must be in remote mode to connect to the desktop software. To enter remote mode; - Power up the instrument - Login as admin user, (the default admin password is admin) - Select settings - Select admin settings - Select Remote mode, the remote mode screen shown below will be displayed while the desktop software is connected. Note: If the instrument is being used continually with the desktop software the check box titled Bootup into Remote Mode can be selected. With this check box selected the instrument will startup and go directly to the remote connection screen and not require login. 11 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

12 4.3 Connect Via USB USB CABLE Desktop Application T16-ISO Instrument Figure 1 USB Setup Configuration A mini USB Cable is used instead of a router to connect the instrument directly to the laptop PC. A. Connect instrument to computer via USB cable. B. Press the power button for one second to power up and start the instrument. Confirm that splash screen is displayed at power up. C. Ensure Instrument is in Remote Mode. D. On desktop software, click Connect to view available units. E. Find instrument on USB list and connect. Figure 2 Connect to an Instrument with USB F. USB connection successful. D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 12 of 14

13 Figure 3 Instrument Connection Status 4.4 Connect Via Network ETHERNET CABLE ETHERNET CABLE DHCP Hub or Router Desktop Application T16-ISO Instrument Figure 4 Network Configuration Setup DHCP Hub or Router and Two Ethernet Cables An Ethernet cable is required to connect the T16-ISO device to a facility network, for network printing and to sync to network date/time settings. You will require two network cables to interface with the router. One to connect the T16-ISO device to the router and one to connect the laptop to the router. The router shall need to be set up to connect to the network. 13 of 14 D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform

14 A. Connect instrument to computer via Ethernet Cables and DHCP Hub or Router. B. Press the power button for one second to power up and start the instrument. Confirm that splash screen is displayed at power up. C. Ensure Instrument is in Remote Mode and observe IP Address. If IP address not shown, refresh instrument network settings by navigating to network settings screen: Settings > Administrator Settings > Network > D. On desktop software, click Connect to view available units. E. Find Instrument on Networking list by matching IP address. Click Locate to confirm choice, instrument will emit a tone. Click to connect to instrument. Figure 5 Connection to an instrument with Networking F. Network connection successful. Figure 6 Instrument connectivity status D004829v1.1 QSG, Quick Start Guide, Desktop Software, Axxin T16-ISO Platform 14 of 14

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