User Manual T16-Isothermal Instrument & Desktop Application
© 2013 – 2017 Axxin Pty Ltd All Rights Reserved. Commercial in Confidence D003374 Version 3.4
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D003374v3.4 User Manual, Instrument and Desktop Application, Axxin T16-ISO.docx
Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
4370 La Jolla Village Drive, Suite 400 San Diego, CA, 92122 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
DOCUMENT CONTROL DETAILS
TITLE
DOC No. CUSTOMER CONTACT
User Manual, Instrument and Desktop Application, Axxin T16ISO D003374
Axxin Internal
DOCUMENT APPROVAL POSITION
NAME
TECHNICAL DIRECTOR
Bill Hopper
SOFTWARE IMPLEMENTATION MANAGER
Daniel Murawczuk
SOFTWARE QUALITY ENGINEER
Navin Jayasinghe
SIGNATURE
DATE
REVISION HISTORY NO.
REVISION DESCRIPTION
AUTHOR
DATE
NKJ
31 Mar 2017
NKJ/TL
13 Feb 2017
3.4
Updated for release 23
3.3
Updated for release v2.1.0.0 software.
3.2
Updated for release of v1.8.1.3 software.
IW
19 Aug 2015
3.1
Updated for release of v1.8.1.X software. Includes Personalization module.
DM
3 Jun 2015
3
Updated for release of v1.8.0.X software. Dual instrument connection supported.
CCH / KSW
13 Mar 2015
2.8
Updated incorrect part numbers
NKJ
18 Oct 2013
2.7
Gradient Information expansion
CCH
24 Apr 2013
2.6
Gradient Information expansion
CCH
17 Apr 2013
2.5
Gradient Stacking and minor edits
CCH
27 Mar 2012
2.4
Updated following normalisation inclusion
CCH
7 Dec 2012
2.3
Updated following Software update.
CCH
27 Sep 2012
2.2
Updated format, customization profile instructions and USB connectivity
KSW
31 July 2012
2.1
Removal of Customization content into separate user manual D003698
CCH
20 July 2012
Minor Updates
CCH
14 May 2012
Updated following R3 Software Release
CCH
26 Apr 2012
2 1.9
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REVISION HISTORY NO.
REVISION DESCRIPTION
AUTHOR
DATE
1.8
Customization section added
CCH
27 Mar 2012
1.7
FCC Statements Included
KSW
23 Mar 2012
1.6
Updated to include
CCH
14 Feb 2012
1.5
Updated following internal review
AL
10 Feb 2012
1.4
Updated following Software Release
CCH
9 Feb 2012
1.3
Minor type fixes
CCH
21 Nov 2011
1.2
Updated following internal review
CCH
18 Nov 2011
1.1
Updated
AL
15 Nov 2011
1
Initial Release
CCH
5 Oct 2011
NOTE: Latest version is first.
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Contents 1 General Information ................................................................................................................................................................. 7 1.1
Warnings & Limitations................................................................................................................................................ 7
1.2
Safety Information ....................................................................................................................................................... 8
1.3
Copyright .................................................................................................................................................................... 9
2 Introduction............................................................................................................................................................................ 10 2.1
Intended Use............................................................................................................................................................. 11
2.2
Contact Information - Axxin Pty Ltd ........................................................................................................................... 11
2.3
Conventions .............................................................................................................................................................. 11
2.4
Abbreviations ............................................................................................................................................................ 11
2.5
T16-ISO Layout ......................................................................................................................................................... 12
2.6
Power Button ............................................................................................................................................................ 12
2.7
External Connectors.................................................................................................................................................. 13
2.8
Lysis Tubes ............................................................................................................................................................... 13
3 Quick Start Guide .................................................................................................................................................................. 14 4 Setup and installation ............................................................................................................................................................ 15 4.1
Firewall exception NEW ............................................................................................................................................... 18
5 Connect Desktop Application to Instrument ........................................................................................................................... 19 5.1
Instrument Modes ..................................................................................................................................................... 19
5.2
Connect to Instrument via USB ................................................................................................................................. 20
5.3
Connect to Instrument via Network ............................................................................................................................ 21
5.4
Connect Dual Instruments to Desktop ....................................................................................................................... 22
6 Desktop Software .................................................................................................................................................................. 23 6.1
Icons ......................................................................................................................................................................... 23
6.2
Connection Status Control ........................................................................................................................................ 24
7 Overview Page ...................................................................................................................................................................... 25 8 Home Page ........................................................................................................................................................................... 27 8.1
Test Setup ................................................................................................................................................................ 27
8.2
Start Test .................................................................................................................................................................. 29
8.3
Run Multiple Tests .................................................................................................................................................... 29
8.4
Stop Test .................................................................................................................................................................. 29
8.5
New Test................................................................................................................................................................... 30
9 Results Display...................................................................................................................................................................... 31 9.1
Save As .................................................................................................................................................................... 34
9.2
Print .......................................................................................................................................................................... 35
9.3
Export ....................................................................................................................................................................... 36
9.4
Open ......................................................................................................................................................................... 38
9.5
Open List .................................................................................................................................................................. 38
9.6
Open Remote List NEW ............................................................................................................................................... 39
10 Test Type Page .................................................................................................................................................................. 45 10.1
Test Parameters ....................................................................................................................................................... 45
11 Algorithm Page ................................................................................................................................................................... 47 11.1
Module Stacking ....................................................................................................................................................... 48
11.1.1
Late Rise Scenario .......................................................................................................................................... 49
11.1.2
Mid Rise Scenario............................................................................................................................................ 49
11.1.3
Early Rise Scenario ......................................................................................................................................... 49
11.2
Assay Channels and Terminology ............................................................................................................................. 50
11.3
Algorithm Time Definition .......................................................................................................................................... 50
11.4
Initial Average Module ............................................................................................................................................... 51
11.5
Gradient Module ....................................................................................................................................................... 52
11.6
Threshold Module ..................................................................................................................................................... 53
11.7
Baseline Correction Δ ............................................................................................................................................... 54
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11.8
Double Differential (PATENT PENDING) ............................................................................................................................... 55
11.9
Test Algorithm ........................................................................................................................................................... 56
11.10 Test Algorithm ........................................................................................................................................................... 58 12 Instrument Page ................................................................................................................................................................. 60 12.1
Print .......................................................................................................................................................................... 60
12.2
Self Test.................................................................................................................................................................... 61
12.3
Park Optics ............................................................................................................................................................... 61
12.4
Default Temp ............................................................................................................................................................ 61
12.5
Temp Offset .............................................................................................................................................................. 61
12.6
Normalize.................................................................................................................................................................. 62
12.6.1
Normalisation Storage ..................................................................................................................................... 64
12.6.2
Normalisation Not Set ...................................................................................................................................... 64
12.7
Personalise ............................................................................................................................................................... 64
13 Sync Page NEW .................................................................................................................................................................... 65 13.1
Add an Outgoing Connection .................................................................................................................................... 65
13.2
Sync Operation (Outgoing Connections) ................................................................................................................... 67
13.3
Add Incoming Connection (Server)............................................................................................................................ 69
13.3.1
Configuring Users ............................................................................................................................................ 69
13.4
Sync Server Operation (Incoming Connection) .......................................................................................................... 70
13.5
Troubleshooting Sync Issues .................................................................................................................................... 71
14 Support Page ..................................................................................................................................................................... 72 14.1
User Manual.............................................................................................................................................................. 72
14.2
About ........................................................................................................................................................................ 73
14.3
Import ....................................................................................................................................................................... 73
14.4
Export ....................................................................................................................................................................... 74
15 Customization..................................................................................................................................................................... 75 15.1
Customization Tool Description ................................................................................................................................. 75
15.2
Icons ......................................................................................................................................................................... 76
15.3
Profile Name ............................................................................................................................................................. 76
15.4
Desktop Settings ....................................................................................................................................................... 77
15.5
Reports ..................................................................................................................................................................... 82
15.6
Software Help File ..................................................................................................................................................... 83
15.7
Desktop Graphics...................................................................................................................................................... 84
15.8
Instrument Graphics .................................................................................................................................................. 87
15.9
Open ......................................................................................................................................................................... 87
15.10 Save As .................................................................................................................................................................... 88 15.11 About ........................................................................................................................................................................ 89 16 Instrument Specifications.................................................................................................................................................... 90 17 12V Power Supply Adaptor Specifications .......................................................................................................................... 91 18 Uninstall the Application ..................................................................................................................................................... 92 19 Troubleshooting.................................................................................................................................................................. 93 19.1
Cleaning.................................................................................................................................................................... 93
19.2
Software Issue Reporting .......................................................................................................................................... 93
20 Warranty & End User License Agreement .......................................................................................................................... 97 20.1
Limitations................................................................................................................................................................. 97
20.2
Design Life and Updates ........................................................................................................................................... 97
20.3
Instrument Failure and Errors .................................................................................................................................... 97
20.4
General Notice .......................................................................................................................................................... 98
20.5
Licensing and Third Party Intellectual Property .......................................................................................................... 98
20.6
Intended Use............................................................................................................................................................. 98
20.7
End-User License Agreement ................................................................................................................................... 98
20.8
Restrictions ............................................................................................................................................................... 99
20.9
Warranties and Disclaimer ........................................................................................................................................ 99
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1
General Information 1.1
Warnings & Limitations Warning: Hot Surfaces. The heater block in this instrument operates at up to 65˚C and may cause contact burns or damage to materials in contact with these areas. Warning: Always operate the T16-ISO on a surface that is level, dry and not exposed to direct sunlight. Warning: Do not move the T16-ISO when conducting a test. Warning: Do not drop the T16-ISO instrument. Warning: Do not place objects on top of or directly against the T16-ISO instrument. Warning: Do not operate the T16-ISO instrument if the power supply pack is wet. Warning: Do not operate the T16-ISO instrument with a damaged power supply pack. Warning: Only use the approved and listed peripheral accessories with the T16-ISO instrument. Warning: Do not use this instrument in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with the proper operation. Warning: Any changes or modifications not explicitly approved by Axxin Pty Ltd could void the user's authority to operate this equipment. Warning: If a USB extension cable is used with the instrument the total length should not exceed 3.0 meters. Warning: Maximum current supplied by all USB peripherals should not exceed 1.1A (2 High power Loads and 1 Low power Load). Warning: This Instrument is designed to operate only with the provided power supply plug pack; This module forms part of the system. Do not operate the system with a different power supply module. The correct power supply is required to maintain the safety and electromagnetic compatibility of the system. Warning: Risk of electrical shock. Do not operate the Instrument or the power supply plug pack if it has been opened, damaged or exposed to moisture, condensation or rain. The external power supply plug pack is sealed with no user serviceable parts. Do not operate this module with any damaged or exposed parts. Warning: Do not open or attempt to repair the Instrument or other accessories as there is a risk of damage to the Instrument. This Instrument does not contain serviceable parts and should be returned to the supplier for repair. Opening the Instrument will also void the warranty. Real time clock coin battery included in the equipment will run for the operational life and is not a user replaceable item.
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Warning: Only operate the Instrument for its intended purpose and in accordance with this user manual and warnings. Protection provided by the equipment may be impaired if the equipment is operated in a manner contradictory to the above. This Instrument (including power supply) is designed to operate within the manufacturers specifications. Do not exceed the manufacturer’s specifications when in use. Warning: Position the instrument with clear access to connectors. Keep connected cables clear of work areas such that tripping or catching will not pull the instrument off its workbench. The mains socket outlet intended to use with T16-ISO external power pack should be located near the equipment and should be readily accessible. It’s recommended that the user unplug the T16-ISO Instrument when not in use. Warning: USB and Ethernet Interfaces: Please ensure that interfaces of such equipment are separated from mains by double reinforced insulation and present no risk of electrical shock if intended for connection to external equipment. NOTE 1.
1.2
Failure to follow these warnings will void the instrument warranty.
Safety Information
The T16-ISO instrument is intended to provide safe and reliable operation when used in accordance to this User Manual. If the instrument is used in a manner that is not specified in the User Manual, the protections provided by the equipment may be impaired. The T16-ISO instrument is designed to operate safely under these conditions:
Indoor use (protected from water).
Altitude up to 2000m.
Temperature 10ºC to 30ºC.
Relative humidity 10% to 70% non-condensing.
Mains supply voltage fluctuations not to exceed ±10% of the nominal voltage.
Installation Categories (Overvoltage categories) II.
Pollution Category 2.
Use with specified and supplied external AC/DC power adaptor only.
Mains socket for AC/DC power pack should be readily accessible.
Set up instrument on a stable, level bench, in an office or laboratory environment.
The T16-ISO instrument is not intended to be used as a hand held instrument; only operate the instrument on a flat and level surface.
Install the T16-ISO instrument at least 100mm minimum from any edges.
Install cables so as to prevent risk of tripping or pull that may cause instrument or personal injury.
The T16-ISO instrument is a non serviceable part, opening the instrument will void the instrument warranty.
Ensure ferrites are fitted to USB peripheral accessories before operation with the T16-ISO instrument.
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1.3
Copyright
© 2013 - 2017 Axxin Pty. Ltd. All Rights Reserved. This manual and software described in it, is provided under license and may be used and/or copied only in accordance with the terms of such license. The content of this manual is furnished for informational use only, is subject to change without notice and should not be construed as a commitment by Axxin Pty. Ltd. Axxin Pty. Ltd. assumes no responsibility or liability for any errors or inaccuracies that may appear in this manual. Axxin Pty. Ltd. and the Axxin Pty. Ltd. Logo are trademarks of Axxin Pty. Ltd. in Australia and/or other countries. Commercial in Confidence
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2
Introduction This document describes setup, configuration and operation of the T16-ISO Instrument that works in conjunction with the AX-ISO Desktop application. The T16 Instrument complies with the emission and immunity requirements described in IEC61326-26. Axxin advises the user to assess the electromagnetic environment of the intended operational environment of the instrument prior to use. The T16-ISO Instrument is a portable, research instrument that provides measurement of three fluorophores; FAMTM, HEXTM and ROXTM. The instrument test set up is conducted on the AX-ISO Desktop application and displays detailed test results of a test that can be exported or printed. The test configuration function allows generalized construction of tests with multiple measurements, workflow and pause steps. Tests can be saved on the controlling computer and used to run tests on any connected instrument. Any number of tests can be created and saved. When running a test, the desktop application displays live graphs of the tube measurements. The application will save and allow measured data, including a .csv file format and graph images to be exported. NOTE 2.
It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to the customer or user.
NOTE 3.
It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the instrument will perform as intended.
NOTE 4.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -
Reorient or relocate the receiving antenna
-
Increase the separation between the equipment and receiver
-
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
This manual, as well as the software described in it, is provided under license and may be used and/or copied only in accordance with the terms of such license. The content of this manual is furnished for informational use only, is subject to change without notice and should not be construed as a commitment by Axxin Pty. Ltd. Axxin Pty. Ltd. assumes no responsibility or liability for any errors or inaccuracies that may appear in this manual. Axxin Pty. Ltd. and the Axxin Pty. Ltd. Logo are trademarks of Axxin Pty. Ltd. in Australia and/or other countries.
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For a detailed explanation for the setup and testing of the T16-ISO instrument in standalone mode, please refer to the latest version of: "D003643 User Manual, Instrument Stand Alone Mode, Axxin T16-ISO" for specific information about T16-ISO instrument setup and configuration.
2.1
Intended Use
This instrument is intended for research and development use only and is not intended for any diagnostic or medical use. This document is provided as an operational guide to describe the use of the instrument. This document does not describe operation of the specific diagnostic test or provide any input to the requirements, safety or processing of any diagnostic test which is outside of the scope of Axxin Pty Ltd.
2.2
Contact Information - Axxin Pty Ltd
AXXIN PTY LTD Original Equipment Manufacture Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
400 Continental Blvd, 6th Floor El Segundo, CA, 90245 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650
www.axxin.com
[email protected]
2.3
NOTE
2.4
Conventions Warning
Indicative of a situation which if not avoided could result in injury of the user and/or damage of the instrument
Hot Surface
This symbol is used to indicate potentially hot instrument surfaces.
USB Connector
USB 2.0 High Speed interface connector
Ethernet Connector
Wired Ethernet ,10/100 Mb/s connector
Power Connector
DC Power connector, for connection with supplied external AC/DC power pack. 12VDC, 3.0 Amp maximum
Information
Critical information relating to procedures or use.
Abbreviations
2D
Two Dimensional
PC
Personal Computer
ID
Identification
PCB
Printed Circuit Board
LCD
Liquid Crystal Display
USB
Universal Serial Bus
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2.5
T16-ISO Layout
3.5” LCD Color Touch Screen - Dynamic Graphics - Workflow Management - Step by Step User Guide - Results Display - Easy to Clean
Lid
Tube locatons1 to 16 200 μL format Minimum 50 μL sample volume
Power button
Communications - USB Connection - Ethernet Connection - Mini-USB Connection (USB Comms Connection)
Power Connector - External 12 V DC - Multi-adaptor for world use
Speaker - Audio Tones - Prompts
2.6
Fluorophore Module System - Replaceable Module - 3 Channels
Power Button
The T16-ISO instrument incorporates a front mounted power button. Once power is connected to the rear of the instrument, press the button for one second to power up and start the instrument. Once the instrument is running it can be turned off (shut down) by depressing the power button for 3 seconds or longer.
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2.7
External Connectors
Figure 1
2.8
T16-ISO Instrument, Back View, External Connectors
Lysis Tubes The T16-ISO Instrument accepts up to 16 Axygen 200µL Tubes. A minimum sample volume of 50µL is recommended.
Warning: Do not apply excessive force. Excessive force could damage the instrument.
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3
Quick Start Guide Install Desktop software Install the Desktop software to a PC running: Windows 7, 32 Bit computer. Windows 7, 64 Bit computer. Windows 8, 32 Bit computer. Windows 8, 64 Bit computer.
Network Connection Setup a DHCP router. Connect the instrument to the router using an Ethernet cable. Connect the PC to the router using an Ethernet cable. The network should setup automatically if a network connection is found during start up.
DHCP Hub or Router 2 x Ethernet Cables OR
Mini USB Connection The instrument can also be directly connected to the PC via a Mini USB cable. Mini USB PC Cable Setup Instrument Inspect the T16-ISO instrument packaging for any obvious signs of damage prior to use. Place the T16-ISO instrument on a stable, level bench, in a clean office or lab type environment.
NOTE 5.
Configure the power supply for your region. Connect the 12V power supply to the unit.
NOTE 6.
Refer to the stand alone operation user manual for the T16-ISO for specific setup and configuration instructions.
Connect power supply to the instrument then press the front power button to start up the instrument. When the instrument has completed start-up, navigate to Settings > Remote Mode.
A USB key is used for export and import functions on the instrument. The SanDisk, Cruzer Blade brand flash memory key formatted for FAT32 with only 1 partition is the suggest USB key device for use.
T16-ISO Instrument and Power Supply
Export Results to USB Key: Use a USB Flash Memory Key to export test results and instrument data from the instrument. Test Package on USB Key: Use a USB Flash Memory Key loaded with a Workflow Test Package to import test types onto the instrument. Software Update on USB Key: Use a USB Flash Memory Key loaded with a Software update package to update the application software on the instrument. The USB key must be connected at start-up and the update placed in the main directory for the update to be detected.
USB key
View the list of instruments available on the same network as the desktop computer running the T16-ISO desktop software. Select the instrument you wish to connect to by identifying it using the IP address listed and matching it to the IP address displayed on the instruments remote mode application screen.
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4
Setup and installation Copy Installer Folder to USB Find the Installer folder in the T16-ISO Desktop Application file directory and copy to USB key. Open Installation Folder on USB on Laptop. Installer files Ensure the T16-ISO Desktop and Customization Tool installers, and the Axxin Default T16 Customization Profile file are in the Installer folder. The T16-ISO Desktop and Customization Tool applications are bundled into installers, *.msi files compatible for compatible with Microsoft Windows 7 and Windows 8, 32 bit and 64 bit operating systems. Install Bonjour Bonjour print services must be installed to run the Desktop application. This needs to be installed once only, and is also found in the installer directory. NOTE 7.
Bonjour Print Services for Windows can be downloaded at: http://support.apple.com/kb/dl999
Recommended Install Procedure:
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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
D003374v3.4 User Manual, Instrument and Desktop Application, Axxin T16-ISO.docx
Install Customization Tool This needs to be installed once only, and is also found in the installer directory. Recommended Install Procedure:
Run Iso Installer.CustomisationTool_ vX.X.X.X.exe
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 Customization Tool\
NOTE 8.
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For Windows 64 bit systems replace "Program Files" with "Program Files (x86)")
Axxin suggests the application be made available for all users on the computer.
Confirm installation process.
Read and accept License Agreement
The Customization Tool application will be found in the Start Menu > All Programs > Axxin > T16-ISO Customization Tool.
D003374v3.4 User Manual, Instrument and Desktop Application, Axxin T16-ISO.docx
Desktop Application Installer This needs to be installed once only, and is also found in the installer directory. The T16 Desktop Customization Profile is loaded during installation. NOTE 9.
To change the installed T16 Customization Profile, uninstall the Desktop application then reinstall the T16 Desktop application and select the new Customization Profile.
NOTE 10.
The Default Axxin T16 Customization Profile, "T16Profile.IsoProfile" is included in Installer Folder.
Recommended Install Procedure:
Run T16-ISO-Desktop_installer_v1.5.0.2.exe
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\
NOTE 11.
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For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
Axxin suggests the application be made available for all users on the computer.
Confirm installation process.
Read and accept License Agreement
In the Customization Profile pop-up screen, click browse, find and open the required Customization Profile file, *.IsoProfile. Then click continue.
Follow prompts to complete installation, including CP210x USB to UART Bridge Driver installation.
The T16-ISO Desktop application will be found in the Start Menu > All Programs > T16-ISO Desktop.
D003374v3.4 User Manual, Instrument and Desktop Application, Axxin T16-ISO.docx
4.1
Firewall exception NEW
NOTE: with the addition of Sync, Sync server, and Open Remote views, the desktop software now requires permission to communicate on the network. It is recommended that during installation, when the windows firewall prompt alert is displayed, both Public and Private Networks are checked to avoid issues with syncing.
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5
Connect Desktop Application to Instrument The connection between the Axxin instrument and computer can be established by USB or Ethernet network over TCP/IP protocol. After installation, Run the desktop software on the computer by navigating to Start Menu > All Programs > T16-ISO Desktop. Select the connect button to view a list of detected Axxin Instruments connected via USB or network. The T16-ISO Desktop application will automatically find and display all supported Axxin instruments.
Figure 2
5.1
List of available instruments
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 12.
Remote mode does not allow the user to operate T16-ISO instrument independently.
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5.2
Connect to Instrument via USB
USB CABLE
Desktop Application
T16-ISO Instrument Figure 3
USB Setup Configuration
Connect Instrument to the computer via a Mini USB cable. On the instrument, navigate to Settings > Remote Mode. The Remote Mode screen should display the COM port number. Run the desktop software on the computer by navigating to Start Menu > All Programs > T16-ISO Desktop. On desktop software, click Connect to view available units. Find the instrument in the USB list and click its Connect button.
When USB connection is successful the desktop displays the connected instrument's COM port number, a connection active icon and a disconnect button. The instrument's remote mode screen displays 1 connection.
NOTE 13.
The COM port number of the instrument should be displayed on its remote mode screen. To find a connected instrument's COM port number via the computer: -
Navigate to the computer's Device Manager via Control Panel\All Control Panel Items\Device Manager.
-
Expand "Ports (COM & LPT)"
-
Find the connected instrument, "Silicon Labs CP210x USB to UART Bridge (COM#)" Where "COM#" is the COM port number of the instrument.
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5.3
Connect to Instrument via Network ETHERNET CABLE
ETHERNET CABLE
DHCP Hub or Router
Desktop Application
T16-ISO Instrument
Figure 4
Network Configuration Setup
Connect the instrument to the Network via an Ethernet cable. Connect the computer to the Network via an Ethernet cable. On the instrument, navigate to Settings > Remote Mode. If an IP address is not displayed on the instrument: Navigate to Settings > Administrator Settings (password protected) > Network. Ensure DHCP is selected then touch to refresh settings. Navigate to back to Home > Settings > Remote Mode. Run the desktop software on the computer by navigating to Start Menu > All Programs > T16-ISO Desktop. On the desktop software, click Connect to view available units. Find the instrument's IP address in the Network list, or type the instrument's IP address into the Manual Connection field, then click its Connect button.
When Network connection is successful the desktop displays the connected instrument's IP address, a connection active icon and an Options button. The Options button provides Disconnect and other features. The instrument's remote mode screen displays 1 connection.
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5.4
Connect Dual Instruments to Desktop
The application can connect to two instruments at a time. Instruments may be connected by different methods e.g. Instrument 1 via Network and instrument 2 via USB; or via the same method e.g. Instrument 1 via Network and instrument 2 via Network.
USB OR NETWORK
T16-ISO Instrument 1 Desktop Application T16-ISO Instrument 2
USB OR NETWORK Figure 5
Dual Instrument Setup Configuration
Follow instructions in the previous sections to connect each instrument to the computer via:
Direct connection to computer using a mini USB cable
OR
Connect using Ethernet cables via a DHCP network hub or router
Follow instructions in the previous sections to connect the Desktop application to instrument 1 via USB or Network. When Instrument 1 is connected, a second Connect button is displayed. Click the second connect button and follow the instructions in the previous sections to connect the desktop application to instrument 2 via USB or network.
When two instruments are connected, the blue line indicates which instrument is selected. To select an instrument, click the instrument’s name / connection status. To disconnect an instrument, click its Disconnect button. Icons indicate the status of each instrument. Each instrument is controlled independently.
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6
Desktop Software The application aims to provide a means of navigating between available functions. It also provides a means of navigating between pages. The order of the pages is fixed. Navigating between pages does not reset or change the content of each page, e.g. data received for test in progress updates the corresponding results page, regardless of whether the user is viewing the page. The blue line indicates which page is displayed. Click a page title to display that page.
Figure 6
6.1
Desktop Application pages
Icons
The following icons are provided on each page:
Open
Open List
Open Remote List
Save
Delete
New
Clone
Save
Delete
New
Clone
Print
Self Test
Park Optics
Home
Save As
New
Stop
Run
Print
Test Types
Algorithms
Instrument
Sync
Add Outgoing Connection
Temp Offset
Normalisation
Personalisation
Add Incoming Connection
Support
Export About
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Default Temp
Test
Import
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Export
6.2
Connection Status Control
This is a specific UI control that is located to the right of the page menus. Due to its importance across the application, it is always displayed. Its status options are ‘Connected’ and ‘Disconnected’.
Displays current connection status.
Provides a list of detected COM ports.
Selecting 'Connect' (from a disconnected state) will fire a request to the Connection Manager.
Selecting 'Disconnect' (from a connected/listening state) will fire a request for disconnection to the Connection Manager.
'Locate' will fire a request for that instrument to emit a locating beep.
Figure 7
Figure 8
Figure 9
Instrument not connected
Instrument is connected
Instrument is running test
Figure 10 Connection Menu
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7
Overview Page The Overview page was introduced to provide a summary of each connected instrument. To run a test from the Overview page, click an Instrument’s Start button. Select a Test Type from the list then click OK.
Enter test details according to the instructions in the Test Setup section. When the instrument is at temperature, test samples are inserted and the lid is closed, click the Start button. Click the Cancel button to stop test. Tests can be independently run on each instrument.
Figure 11 Connected instruments running tests at the same time
When a test is completed, clicking View Detail navigates to that instrument’s Home page. Click clear to run a new test.
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Figure 12 Test Completed
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8
Home Page The Home page enables viewing of incoming results from an instrument. Results are displayed in both a graphical and numeric format during testing and once testing is complete. Various view points for a test result are presented. This page can also display a previously run test is loaded into the system. The Run button is disabled if no instrument is connected. Use the Test Profile selection box to make a test type selection prior to running test. Navigation between pages, instruments, or switching tube views does not affect incoming results on a running test. User can navigate away from a Home page while a test is in progress. If two instruments are connected, there is effectively a Home page for each instrument. A blue line below the instrument's connection status indicates which instrument's Home page is displayed. Click an instrument’s name / connection status to display that instrument's Home page.
8.1
Test Setup
To run a test from the Home page:
Select an instrument by clicking its name / connection status..
Click the Run button, select a previously created Test Type (with associated decision algorithm) from a drop down list and select “OK”
Figure 13 Home > Run > Select Test Type
The instrument will adjust the tube temperatures according to the test type settings. The Start Workflow button located at the bottom of the screen will be disabled until the instrument is ready. The tube diagram on the screen will display in which tube locations are under test. In the example bellow, a sixteen tube test is about to be performed.
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Enter:
User Name
The Lot ID of the test batch
Sample ID for each tube under test.
NOTE 14.
User Name and Lot ID are pre-filled with previous entries.
Figure 14 Instrument Ready, Temperature Adjusted
To enable the rapid entry of Sample IDs, if an alpha followed by a numeric Sample ID is entered (for example ABC01) then the information can be auto filled. The auto fill icon will appear in the Tube 01 Sample ID field only once a numeric has been entered.
If a Sample ID is not entered for a Tube, no result will be displayed for that tube; instead the “No Sample ID” icon will be displayed. A warning underneath the Sample IDs indicates when no data is entered and because of this no result can be displayed.
Figure 15 Empty Sample ID prompts warning
Figure 16 Results Screen showing ‘No Sample ID’ icon
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8.2
Start Test
Once the sample tubes have been inserted, the test information has been entered, including all Sample IDs as required, the instrument is at temperature and the instrument lid is closed, the user is ready to start a test.
Figure 17 Test is ready to start
Close Lid: The instrument lid must be closed at the start of a test. Once the test workflow has started, lid open and close events are recorded in .csv file.
Figure 18 Close lid to start test message
8.3
Run Multiple Tests
The desktop software can independently run tests on two connected instruments. While a test is running on the first instrument, click the second instrument’s name / connection status to display the second instrument's Home page. Follow the instructions in the previous Test Workflow and Run Test sections.
8.4
Stop Test
Click the Stop button if you wish to cancel a test in progress.
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8.5
New Test
Click the New Test button to clear the Home screen.
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9
Results Display 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. Below is a screen shot example of a sixteen tube result on the default landing screen of the test results.
Figure 19 All Tubes graph summary
NOTE 15.
Sample IDs are shown in the left hand navigation column.
NOTE 16.
Graphs can be displayed dynamically or statically, configure in the T16-ISO Customization Tool.
Figure 20 Example of Result Displayed on the graph
To change the views of the All Tubes graph summary, the user can switch between normal, first and second tube derivatives and choose which of the FAM™, HEX™ or ROX™ channels to display.
Figure 21 View options and Legend
Tube Overlay: The tube overlay graph displays the data readings for all Tubes tested in one graph. The graph can only display results for one (FAM™, HEX™ or ROX™) Channel at a time. Tubes
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hidden and displayed are configurable by the check boxes on the right hand side of the application window.
Figure 22 Tube Overlay graph
Temperature: The “Temperature” graph displays the T16-ISO temperature readings taken throughout the test time.
Figure 23 Temperature Graph
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Results: The results view visually displays the tube results with one of the following possible results: Positive Result Negative Result Invalid Result No Sample ID entered
Figure 24 Test Results showing Positive and Negative results
Figure 25 Duplex Test Results showing Positive and Negative results across 2 channels
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Tube 1 to Tube 16: displays the individual graph for the that tube and offers the same graph configurations of normal, first and second tube derivatives and choose which of the FAM™, HEX™ or ROX™ channels, available in the All Tubes view. 1-Tube (full page) view displays the graph in more detail. ‘Mouse-Over’ style hovering on data points displays information about that data point (e.g. time, raw figures).
Figure 26 Single Tube graph
Comments: fields can be entered and edited on running test, completed test, and previously saved test. Additional Test information can be added to the comments section to help a user distinguish tests.
9.1
Save As
The application automatically saves test results to a location in the windows file location. The default file location allocated during the application installation process is: C:\Program Files\Axxin\Axxin T16 ISO Desktop\TestResults NOTE 17.
For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
The test results are .JSON files that can be opened and viewed within the T16-ISO Desktop Application and exported and printed. The test results are automatically assigned a default file name. The first 8 characters of the instrument serial ID form the Instrument ID: Example: CCEEC413_20120427105101.json Filename format Example
Instrument ID
_
yyyy
mm
dd
hh
mm
ss
File extension
CCEEC413
_
2012
04
27
10
51
01
.json
The Save As function allows the user to resave a results file under a default name or with a user configured name in a user specified file location.
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9.2
Print
The user is able to export an A4 test result file to save as a .pdf or print. The T16-ISO Application offers two print options:
Summary Report: A one page summary based on the application results view.
Tube Graphs including: Tube 1 to 16 Results, Tube Overlay and Temperature Graphs.
This can be at the completion of a test or from the review memory screens.
Figure 27 Print Results window
TUBE SUMMARY REPORT
TUBE GRAPHS, PAGE 3/5
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GRAPHS, PAGE 1/5
TUBE GRAPHS, PAGE 2/5
TUBE GRAPHS, PAGE 4/5 TUBE GRAPHS, PAGE 5/5 Figure 28 Print Results preview, Summary Report and Tube Graphs
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9.3
Export
The export function available for Test Results allows the user to export the test data to a .csv file which is compatible and editable in excel, along with the image files of each of the graphs.
Figure 29 Export Results window
Data Files: Saves the test result as a .json file in a user specified file location. CSV (Spreadsheet) data: The test data is automatically saved in .csv file format upon completion of a test. The .csv files are automatically assigned a default file name. For example: C9A4EA13_20120229015400_4bce65eb-1b59-4f98-83aa-b1decbee4439.csv Filename format:
Instrument ID
_
yyyy
mm
dd
hh
mm
ss
Auto-generated Unique ID
File extension
Example:
CCEEC413
_
2012
02
29
01
54
00
4bce65eb-1b594f98-83aab1decbee4439
.csv
The .csv file displays a maximum of 48 columns of results. This includes three fluorescence channels, FAM, HEX and ROX read for 16 tubes. A list of line items is included bellow:
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Edited .csv test record and results information: Axxin Isothermal Reader: Test Record Test Name Test Start Time and Date Comments Run Result
User Name:
Mode
Lot ID:
Duration (Sec)
Sample ID entries
Silicon ID
Tube Index
Application Version
Workflow Items:
Firmware Version
Algorithm Decision Definition:
Settings
Decision Name:
Set Temperature
Control Type:
Channel
Channel 1 Type:
ROX LED PWM %
Channel 2 Type:
HEX LED PWM %
Channel 1 Test Name:
FAM LED PWM %
Channel 2 Test Name:
Channel 1 Mappings: Control:
Channel:
Result:
Workflow Items: Control: Type:
Start Time:
End Time:
Asserted Expectation:
Non-Asserted Expectation:
Asserted Link:
Start Time:
End Time:
Asserted Expectation:
Non-Asserted Expectation:
Asserted Link:
Channel 1: Type: Events Workflow Events List: Time
Elapsed Time (sec)
Workflow Index
Workflow Status
Workflow Type
Instrument Lid Status: Time
Elapsed Time (sec)
Event
Full Results Table Time
Elapsed Time (sec) Event
Tube 1 FAM
Tube 1 HEX
Tube 1 ROX
Elapsed Time (sec) Event
Tube 1 FAM
Tube 1 HEX
Tube 1 ROX
Elapsed Time (sec) Event
Tube 1 FAM
Tube 1 HEX
Tube 1 ROX
Full Results Timestamp Table Time Tube 1 Data Time Temperature Time
Elapsed Time (sec)
Temperature (Deg C)
Assay Decision Tube 1 (Channel 1) Result: Control Interpretation: Channel 1 Interpretation: Channel Evaluation Criteria Results Channel: Criteria Index
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Criteria Name
Evaluation Criteria Result
Evaluation Description
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Graphs: The following graphs generated as part of the T16-ISO Test result are included in the printed report:
All individual Tubes
Tube Overlay Defaults
Tube overlay as configured on screen
Temperature
9.4
Open
Previously saved test data can be opened from a file directory and viewed. Opening a test is independent on instrument connection; however a test can be opened to a connected instrument's Home page only if there is no running test. If one instrument is running a test, select the other connected instrument or the instrument icon above the Connect button before opening a test. Clicking the open button opens a navigation screen. Default location: C:\Program Files\Axxin\Axxin T16 ISO Desktop\TestResults\Records NOTE 18.
For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
Select a Test Record file then click Open.
9.5
Open List
Clicking Open list displays a summary list of all test record files in a directory. Default location: C:\Program Files\Axxin\Axxin T16 ISO Desktop\TestResults\Records NOTE 19.
For Windows 32 bit systems replace "Program Files" with "Program Files (x86)"
In the open list window:
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Change the directory displayed by clicking the directory path. Navigate to then click on the folder, then click Open.
Search for a test record by typing in the box marked “Search…” and clicking the magnifying glass or hitting Enter. The search is case insensitive and will filter the currently displayed results based on the search term, showing results which have matches in their: o
Test Type name
o
Filename
o
Test started date / time
o
User ID
o
Lot ID
o
Sample ID
o
Test Result (will only match the complete string i.e. “positive”, “negative” or “indeterminate”).
Click the Reset button to clear the search term, reset the directory to the default and remove any result filter.
Click Print to view a PDF version of what is displayed on screen (filtered search results included).
Click Export to export the test record's CSV and/or Data File (json).
Click Load to open the test record in the Home page.
9.6
Open Remote List NEW
Open Remote List allows a user to access and download test files saved on a remote server. Users can navigate SFTP or FTP servers, and download relevant results for review. The T8 desktop software supports viewing (and listing) of T8 results only (.csv files). 9.6.1.1
Add and Remove ‘Open Remote List’ Profiles
To set up a remote connection, click on the Open Remote List button. From the drop-down list, select New Connection.
Figure 30 Set up a new connection
When prompted, fill in the remote server’s details in the Add Connection window.
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Figure 31 Add connection details
The following fields must be filled in:
Address – IP address or domain name of the remote server. eg: 118.168.4.75 or sftp.example.com
Type – The type of server the user is connecting to. This can be either SFTP or FTP.
Port – The port number through which the server can be reached.
Destination Directory – The user can explicitly specify which subdirectory (on the remote server) should be viewed. If this field is left blank, the root directory of the server will be displayed.
User Name/ Password – The user’s login credentials for the remote server.
It’s useful to click on the Test Connection button to confirm the entered details are valid. An error icon will be displayed if the connection was unsuccessful, along with further details for troubleshooting.
Figure 32 Test Connection failed
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Figure 33 Hovering over the error icon will provide helpful information for troubleshooting
A few common connection errors are:
Incorrect IP address
Incorrect server type – the desktop software supports connecting to SFTP/FTP servers
Incorrect or invalid user login credentials – The user must have access to the server for results to be listed.
If all fields are valid and correct, Test Connection will indicate that a connection could be successfully made.
Figure 34 Test Connection was successful. The Open Remote List profile can now be added
The user can now add the profile, by clicking the Add button. Once a profile has been created, the user can add other profiles too, to browse other desktop servers.
Figure 35 A list of other valid Open Remote List profiles. Each will pull results from a different server
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To delete a profile, click the red ‘X’ icon as shown below:
Figure 36 Click the red X icon to delete a profile.
9.6.1.2
Browsing, Viewing and Downloading Results
Once a valid connection has been established, the user can now browse results on the remote server.
Figure 37 A collection of test result files on the remote server
The user can navigate up a folder by clicking “Open” on the Parent Folder. Similarly, clicking “Open“ on a subfolder will display that subfolder’s contents. A user can also search for test results using the search field.
The search field will look for matching filenames, and will return a list of partial matches as well. Once a relevant result has been located, click on the Load button:
Figure 38 View a result by clicking Load
The result is loaded into the desktop view:
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Figure 39 Loaded result from Open Remote View
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Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
4370 La Jolla Village Drive, Suite 400 San Diego, CA, 92122 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
Viewing a result remotely does not automatically download it. To do this, click on the “Export” button, and provide a local location for the file to be saved to.
Figure 40 Click on Export to save the file to a local location.
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10 Test Type Page The Test setup is conducted under the Test Types page 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. User can clone a profile but must enter a new unique name for the new profile.
10.1
Test Parameters
Select tubes to use (read) in a test. It can be any combination of 1-16 tubes
Select channels to read (e.g. FAM, HEX and ROX)
Select LED Settings
Set Chanel LED levels (as a percent)
Set test duration
Set test temperature
Figure 41 Test Types page
Workflow: The test workflow is set up using a drag and drop input method. Each workflow step is configurable:
Pause: Set wait time 10-1200 seconds (20 minutes max) when T16-ISO instrument is at temperature; User Interface Message text required to save test type profile.
Read: Set read time 50-3600 seconds (60 minutes max)
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.
NOTE 20.
Test may not stop exactly at time specified as the T16-ISO Instrument must complete its scan cycle and return to the 'home' position. This may cause the algorithm end time to be extended by set time + seconds taken to complete scan cycle.
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Figure 42 Test Workflow and Workflow Toolbox
The Test Type contains a collection of predefined default profile spots. If user has edited and navigates to another profile, the user shall be prompted that they will lose the changes if they proceed. Configure Tube Label: The ID of each tube can be configured in the Test Type menu by entering an eight character label.
Figure 43 Configure Tube Label
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11 Algorithm Page The Axxin AX-ISO desktop provides a general algorithm editor to generate customized logic to suit the response of specific assay and test results. The general principle of this editor is that decision components can be selected from a toolbox and dropped into a list to be executed by the software. Each component has specific parameters that can be configured by the user.
Figure 44 Algorithm Page
The output from each component is either true or false. These outputs can be combined with either an “OR”, “AND” or “ANY” operator to form a result. This logic is independently specified for a positive or a negative result. The result will be invalid if it is either negative or positive, or in the event that it is scored to be both Negative and Positive. The calculation modules offered in the AX-ISO decision toolbox are:
Baseline Correction
Initial Average
Threshold
Gradient
Second Derivative (Patent Pending)
NOTE 21.
Test may not stop exactly at time specified as the T16-ISO Instrument must complete its scan cycle and return to the 'home' position. This may cause the algorithm end time to be extended by set time + seconds taken to complete scan cycle.
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11.1
Module Stacking
Module Stacking can be used if a user wishes to add two or more module options to the Algorithm. "Stacking" of gradient module options one after another and using the "OR" relationship enables the algorithm to run in the following way.
Figure 45 Gradient Stacking Logic
The figure bellow show how the gradient stacking method looks when building an algorithm.
Figure 46 Example of Gradient Stacking
See Section 11.5 Gradient for more information on Gradient calculation and how the Gradient parameters are used. Refer to following page for scenarios.
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11.1.1 Late Rise Scenario mV
GRADIENT 1
GRADIENT 2
or
Asserted: False
Asserted: False
or
GRADIENT 3 Asserted: True
AVERAGE TEST & Asserted: True
t t2 t1
t1
t2
t1
t2 t2
t1
11.1.2 Mid Rise Scenario mV
GRADIENT 1
GRADIENT 2
or
Asserted: True
Asserted: False
or
GRADIENT 3 Asserted: False
AVERAGE TEST & Asserted: True
t t2 t1
t1
t2
t1
t2 t2
t1
11.1.3 Early Rise Scenario mV
GRADIENT 1 Asserted: True
GRADIENT 2
or
Asserted: False
or
GRADIENT 3 Asserted: False
AVERAGE TEST & Asserted: True
t t1
t2 t1
t2 t1
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t1
t2 t2
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11.2
Assay Channels and Terminology
A typical assay has several channels of fluorescence. In the Axxin instrument these are typically labeled FAM, HEX and ROX. In the Assay decision logic up to three channels can be considered; Control, Channel #1 and Channel #2. The software allows the user to define the test specific name for channel 1 (and Channel 2 if it is enabled). As an example an Assay channel name may be assigned as Control, Alpha and Beta. The decision logic for each channel is considered first and it will be calculated by the algorithm to be asserted, not asserted or indeterminate. These individual channel results are then combined to form an Assay Result. A logic table is provided in the software to allow the user to define how the channel results are combined to form the assay result. The Assay Result can be Negative, Positive or Indeterminate.
Figure 47 Algorithm Page, Channel 1 Decision Logic settings
11.3
Algorithm Time Definition
The Algorithm editor provides two different options for determining start (t1) and end (t2) window times.
From first data point of each Tube (Default)
From first data point of the test run (Tube 1)
Figure 48 Screenshot of Algorithm Page, Time Definition
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11.4
Initial Average Module
The Initial Average module allows a check that the Assay starts correctly within a specific range.
mV
T MAX Average value MIN
t t1
t2 Figure 49 Calculating the Initial Average
The function confirms that the assay average within the time window t1 to t2 is within the range minimum value to maximum value. This function can be used to ensure that the assay starts with a low value and only subsequently rises higher to form a positive result. If the assay average is within the min and max limits the function is true. If the assay average is outside the bounds the function is false. If the tube scan time is less than the period of T then only a single data point above the threshold is required for the function to be true.
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11.5
Gradient Module
The gradient module function is a test that can be applied to check the slope of the assay curve. The function will be true if the gradient is above the gradient threshold for more than a present period Time Above Threshold (T).
mV T
t Gradient test window
t1
t2
Figure 50 Gradient Test Overview
The gradient test is only applied within a time window defined by the t1 and t2 values. The tube readings within the period T must all be consecutive with gradients above the gradient threshold. If the tube scan time is less than T then only a single data point above the threshold is required for the function to be true. Gradient Calculation: The gradient for each point in the result curve is calculated by using the data point at each side of it.
mV
x gradient
ΔV x
Δt t Figure 51 Gradient Calculation
The gradient of point x is calculated as
∆𝑉 ∆𝑡
as shown in the diagram above. The very first and very last
data points in the test will not be used as they do not have a data point on each side. Therefore point
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(X) marked on the diagram above is used as it is the first data point to fall "within" the Gradient Test window. Time Above Threshold (T): The following diagram describes the Data points included in the algorithm calculation of Time Above Gradient.
mV Points above Gradient Threshold
t Time Above Threshold (T)
Figure 52 Definition of Time Above Threshed (T) with consecutive Gradients
mV Points above Gradient Threshold
Time Above Threshold
(T)
t
Figure 53 Definition of Time Above Gradient (T), where consecutive gradients are equal to one (=1)
The T16 will have different scan times if a different number of tubes are specified to be used in the test. For example an 8 tube test may requires three data points to be above gradient in the time T while a 4 tube test with the same algorithm may require only three points in the same period T. This is because the T16-ISO will have a shorter time between readings for a specific tube when it only reads 4 tubes compared to 8 tubes.
11.6
Threshold Module
The threshold test is used to confirm that the assay curve rises above a threshold value for a minimum time T to be true. The threshold test operates within a time window defined as t1 to t2.
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T
mV
Threshold set value
Δ t t1
Test applied window
t2
Figure 54 Threshold Algorithm
The curves must be above the threshold for a minimum time T for the function to be set “true”. If the tube scan time is less than T then only a single data point above the threshold is required for the function to be true. A typical assay test may include multiple threshold tests. The diagram shows some possible examples:
mV
[1] [2] Gradient Test [3] Initial Average
t Threshold [1]: Assay is automatically positive. Threshold [2]: Required for assay to be positive. Threshold [3]: Below this threshold (threshold is false) the assay can’t be positive. Figure 55 Multiple Threshold Types
If the tube scan time is less than T then only a single data point above the threshold is required for the function to be true.
11.7
Baseline Correction Δ
In some applications each curve may be corrected to have a common baseline based on the average value acquired within an initial period. This correction is referred to as Delta (Δ) and is shown in the graph below. The Baseline Correction module calculates an average level — using the same functionality as Initial Average.
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Baseline correction does not affect a gradient calculation but it does have an effect on any absolute thresholds applied in the Assay algorithm. For this reason, as a simplification in the calculations, every point in the graph is not adjusted down for the baseline correction, rather any thresholds applied are adjusted up by the same (Δ) value. The effect of this approach is identical and is represented in the graph below.
mV
Baseline correction threshold value
Δ Threshold set value
Δ t t1
t2 Figure 56 Applying Delta (Δ) to Normalize
A typical example of the use of the Baseline Correction is explained below:
Figure 57 Example usage of Baseline Correction with additional modules
The Baseline Correction module calculates an average value Delta (Δ) that can be applied in any subsequent threshold calculation modules. Only one Baseline Correction module can be defined, however multiple threshold modules can be applied within the Assay Algorithm. With in a subsequent Threshold module, the threshold can be a fixed, absolute value or it can be baseline corrected if the "Use baseline correction or threshold" check box is selected. Where this check box is selected the threshold is increased by the value (Δ), calculated for each individual test. This is equivalent to applying the absolute threshold to a curve that is corrected down to the baseline by the baseline correction value (Δ).
11.8
Double Differential (PATENT PENDING)
Axxin have developed a double differential assay test particularly suited as a tool to detect “low positive” and “late positive” assay responses. This function will be provided in future releases of the software.
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11.9
Test Algorithm
The Algorithm Page has a test function that runs a simulation of the current specified Algorithm, as a tool to enable the user to understand and verify the correct functionality of the decision logic they have constructed.
Figure 58 Algorithm Test Results Window
The user can create an Algorithm then test the Algorithm using the Test Button. Return to the Results page, then click the "1st Derivative" view. The user can now view the Gradient calculations. Hover over points to view the elapsed time information.
Figure 59 View of Gradient Calculations
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Figure 60 View of Gradient Calculations in the Test Page
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11.10 Test Algorithm The Algorithm Page has a test function that runs a simulation of the current specified Algorithm, as a tool to enable the user to understand and verify the correct functionality of the decision logic they have constructed.
Figure 61 Algorithm Test Results Window
The user can create an Algorithm then test the Algorithm using the Test Button. Return to the Results page, then click the "1st Derivative" view. The user can now view the Gradient calculations. Hover over points to view the elapsed time information.
Figure 62 View of Gradient Calculations
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Figure 63 View of Gradient Calculations in the Test Page
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12 Instrument Page The Instrument page displays information about a currently connected T16-ISO instrument with the aim of aiding in the identification of an attached T16-ISO Instruments. Instrument logs and an export/print function are also available. If two instruments are connected, click the second instrument’s name / connection status to view the second instrument’s information.
Figure 64 Connected T16-ISO Information page
12.1
Print
Using the print function the user can generate a one page A4 report on the T16-ISO Instrument used for testing.
Figure 65 Instrument page, Print, Preview
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12.2
Self Test
The self test functionality enables a user to run a series of T16-ISO Instrument function tests remotely using the T16-ISO Desktop application to ensure proper function of the instrument. Such tests are either fully automated or require user confirmation of correct function. The status indicators used
12.3
pass or
fail display the self test result.
Park Optics
The park optics button commands the T16-ISO Instrument Optics Module to move across where it can be accessed through the Module Bay Cover.
12.4
Default Temp
The user may wish to set a default temperature that the T16-ISO will automatically reach when powered up. Set the Temperate in the text box input. Temperature is in Celsius at ± 0.1ºC.
Figure 66 Default Temperature Setting
12.5
Temp Offset
If the user suspects the T16-ISO instrument is producing a higher or lower temperature reading than expected. The user may wish to apply a temperature offset to correct the reading. It is recommended that the user contacts the manufacturer.
Figure 67 Setting Temperature Offset
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12.6
Normalize
A normalization function has been incorporated into the T16-ISO product. The sensitivity of the instrument is dependent on the assay fluorescence chemistry used. For this reason, where normalization is to be applied, it is recommended that the user normalize against a reference that they intend to use for their test system. Typically this reference will be used across the system to ensure that both the normalized instrument and assay response do not drift or change over time. Instrument normalization forms part of the instrument QC process. Due to minor mechanical tolerances and differences in manufacturing, conducting normalisation on both Tube 1 and 16 locations will allow the Normalization factor level to be averaged depending on the Tube location.
Figure 68 Instrument Normalisation
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Example: Tube 1 Normalisation Factor level: 0.900 Tube 16 Normalisation Factor level: 1.100 A table of factors is created that the software will apply based on the above Tube 1 and Tube 16 normalisation factors: 1
2
3
4
5
6
7
8
0.900 0.9125 0.9250 0.9375 0.950 0.9625 0.9750 0.9875
9
10
11
12
13
14
15
16
1.0125 1.0250 1.0375 1.050 1.0625 1.0750 1.0875 1.100
The main requirements for setting normalisation are:
Obtaining multiple readings for the given tube location (tube 1 or tube 16), at a user-defined temperature and LED intensity.
Suggested normalisation values based on obtained readings.
Reading while the instrument is at a desired set temperature.
Entering additional text information about the normalisation routine.
The function allows users to run a reference tube and enter its target value. The software will run the instrument and determine by test the normalisation values that will provide the required target reading. However the user is required to enter the factors into the apply fields. This approach allows the user to directly enter normalisation factors if they are already known. Alternatively the user may wish to return the factors back to 1.000.
Enter set temperature, desired LED intensities, and target values.
Enter a prepared sample into the Tube 1 location, and click on Read Tube 1 for that corresponding optics channel.
After a short time, the reads will complete and the corresponding fields below the Read button will populate.
Repeat steps for Tube 16, and the other optical modules. Once complete, click apply to continue to the confirmation screen. Example:
Figure 69 Setting Normalisation Values
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12.6.1 Normalisation Storage The normalisation data is stored on the instrument, in the existing factory calibration data. This allows other desktop installed software from different computers to connect and use the same normalisation. The desktop obtains normalisation data from the instrument connected. This allows the stand-alone instrument to also use the normalisation data for stand-alone test runs. Normalisation data will be captured in the following areas:
Desktop Log file (on applying/resetting normalisation on an instrument).
Instrument Log file (on both applying/resetting normalisation and every test run).
JSON Test Result file (normalisation data embedded into test result files).
CSV exported Test Result files.
NOTE 22.
The normalisation data is retained during desktop and instrument updates.
12.6.2 Normalisation Not Set Where an instrument has never been normalized, or the normalisation has been reset the instrument uses default values of 1.000. NOTE 23.
12.7
There are no error messages if normalisation has not been set. Instruments built at Axxin are released without normalisation.
Personalise
The operator is now able to apply a custom name and color to the instrument. This helps further distinguish multiple T16s that may be present.
Figure 70 Instrument Personalisation
The applied settings are shown in: -
The Network browser, on all Desktop applications running within the local network.
-
The available USB combo/connection box.
-
The Connected panel, when connected.
-
The Overview tab.
-
On the instruments’ Remote mode screen.
The personalise data is saved onto the instrument, and retained during instrument software update.
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13 Sync Page NEW The T16-ISO desktop now supports synchronizing test results saved on the laptop to a remote server. This is known as the “Sync” function. This Sync is unidirectional; results can only be transmitted to the server, and not retrieved. Up to two remote Sync profiles can be configured for use. A sync profile will look for test records to transfer to the server. It’s important to note that only results that reside in the Records folder will be synchronized. By default the records folder is created in C:\Program Files (x86)\Axxin\Axxin 16 ISO Desktop\TestResults\Records In addition, the software can also be configured to act as a server, and receive test results when transmitted by another desktop sync profile. This is convenient when several instruments are in use, and it’s necessary to store a copy of all results in one centralized location.
13.1
Add an Outgoing Connection
Figure 71 Add a new Sync profile
Adding an ‘outgoing connection’ can be thought of as creating an automatic backup. When an outgoing connection is configured, any new results will be transmitted to the designated server. To create a sync profile, click the ‘Add Outgoing Connection’ button. When prompted, enter the required server details:
Figure 72 Enter sync server details
The following fields need to be set:
Address – The address of the remote server. (E.g.: 192.168.10.10 or server.example.com)
Type – Selected between SFTP and FTP
Port – The server access port number
Destination Directory – The location where files will be stored on the server. (E.g.: MyT16Results will store the results in server.example.com/MyT16Results)
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User Name/ Password – Authentication credentials for the server
Periodic Sync – If enabled, the software will transfer any unsynced results every 10 minutes to the server. If disabled, the user must manually initiate the Sync function.
Click Test Connection to confirm that with a valid username and password, a connection can be made to the server. If successful, a green ‘success’ icon will be displayed:
Figure 73 Valid parameters entered for the sync profile
If unsuccessful, the software will indicate which field was invalid
Figure 74 Invalid connection parameters
In the above screenshot, the login credentials were incorrect. Hovering over the red exclamation icon will provide more information about the error
Figure 75 Further information about a connection error
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13.2
Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
4370 La Jolla Village Drive, Suite 400 San Diego, CA, 92122 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
Sync Operation (Outgoing Connections)
Two outgoing connection profiles can be configured for use. It’s important to note that while a test is running, no Sync operations will be performed. The \TestResults folder is the ‘root’ folder which the Sync function will search through to find files. Additionally, the Sync function will search 3 levels deep through subfolders for other files to transmit. It’s important to note that test results are saved in \TestResults\Records by default. As an example, any files that have been saved in \TestResults\Records\SubFolder will be transmitted, however, data in \TestResults\Records\SubFolder\AnotherFolder will be ignored. NOTE: Sync is restricted to transmitting only .csv files, the main file format exported/saved by the T8 desktop software. Other files in the \Records folder (if any) are not transferred. NOTE: Result files larger than 5Mb will not be transferred. During normal operation, it is unlikely that a result file larger than 5Mb will be generated.
Figure 76 Example of a sync profile ready to transmit
Clicking on the ‘Sync Now’ button will force the desktop software to connect and transmit data to the server.
Figure 77 Additional options under “More…”
Clicking on the ‘More’ button will display additional profile options:
Remove – Will remove the sync profile.
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Edit – This will allow the user to edit the sync parameters for the profile, as in Figure 61.
Test Connection – Test the current connection parameters. If the connection was successful, a green tick icon will be displayed next to the test connection button. If unsuccessful, a red error icon is displayed.
Enable/Disable Periodic Sync – Toggle between Periodic Sync being enabled or disabled. Once enabled, the Sync process will begin immediately to transmit any unsent results.
Figure 78 Sync in progress
While files are being transmitted, the sync profile displays the text ‘Running’ and begins counting down the number of files remaining to be pushed to the server. The user cannot trigger a manual sync or modify the contents of the sync profile while a Sync is in progress.
Figure 79 Sync completed successfully
Once all files have been successfully pushed to the server, the User Interface will display ‘Synchronized’. If periodic send is enabled, the time the last transmission was successful will be displayed along with the time the next Periodic Sync will happen.
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13.3
Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
4370 La Jolla Village Drive, Suite 400 San Diego, CA, 92122 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
Add Incoming Connection (Server)
The software can be configured as a server, to receive data transmitted by a sync profile (outgoing connection) from another instance of desktop software on a separate computer. Click Add Incoming Connection: The following fields need to be filled out by the user: File Storage Path – The location where received results will be saved. Start Server on Instrument Startup – If this is checked, the server will be online and ready to receive files, as soon as the desktop software is powered up. Connection Port – Specify the port number over which results can be received. User management – At least 1 user needs to be created before a server can be set up. (see section below)
13.3.1 Configuring Users To create a user, enter a user name between 5 and 20 characters. Enter a password for this user. The password must: be between 6 and 20 characters contain at least 1 capital letter contain at least 1 number contain at least 1 non-alphanumeric character (eg: #, $, @) not match the username.
Click on “Show Passwords” at the bottom of the panel to simplify user creation. To delete a user, click on the red “X” next to their entry.
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13.4
Sync Server Operation (Incoming Connection)
Once a server is added, the desktop software is now ready to receive test results.
Only 1 Sync server (Incoming Connection) configuration can be set up and active at any time. It’s important to note that the sync server will only run as long as the desktop software is open; if it is closed, any profiles which are configured to transfer results to it, will be unable to do so.
A server is set up and running on these IP addresses. The following pieces of information are displayed to the user:
The local IP address(es) on which the server can be connected to. (Note: if attempting to connect from a computer that is not on a local network, use your global IP address instead.)
The Connection Type – the server type is SFTP
Auto-start – Whether the server will automatically start once the desktop software starts
Port – the port on which data can be transmitted
Storage Location – The folder in which received data will be stored.
Server state – Online or Offline
Current Connections – The number of users currently connected to the server
Files Received – The total number of files received for the duration of the server session (i.e.: from the last time the desktop software was opened).
Last File Received – The filename of the last file transmitted.
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Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
400 Continental Blvd, 6th Floor, El Segundo CA, 90245 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
For additional configuration options, click on “More…”
Figure 80 Additional options for the server
The user can delete or edit the server configuration, and view server logs if required. Server logs are useful for troubleshooting connectivity issues.
13.5
Troubleshooting Sync Issues
Sync issues may be related to the structure of the network the user is operating on. In the majority of cases, issues can be resolved by adjustments to the network. By default, on installation, the desktop software will prompt the user to add a firewall exception. It’s required that this be done before sync will work. It’s worth checking that a firewall exception (for both public and private networks) has been added if you’re experiencing sync issues. Additionally, it’s worth checking that the IP address used for a sync profile correctly matches the IP address of the target server. If connecting to a server that’s not on the local network (i.e.: a server on the internet) ensure the target IP is the server’s public IP address, and that a port has been forwarded for this purpose. Contact your IT group for assistance with this.
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14 Support Page The T16-ISO Desktop application Support page provides a copy of the T16-ISO Instrument System user manual as well as information about the T16-ISO Application and import/export functions to enable users to set up and configure installed T16-ISO Desktop applications with the desired Test Types and associated algorithm decision logic.
14.1
User Manual
The T16-ISO Instrument system user manual is imbedded into the application as a .pdf file and can be saved or printed from this screen. The .pdf viewer also provides a “find” function to enable quick search of key terms. NOTE 24.
Adobe Reader must be installed to view help files.
Figure 81 Support page window
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14.2
About
The Help page provides informative instructions to the user when desired, including support links and application version information.
Figure 82 About window
14.3
Import
The import function in the support screen enables a user to import test types (with associated algorithms) created on another installed version of the T16-ISO Desktop for testing on a connected T16-ISO Desktop.
Figure 83 Import test types process
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14.4
Export
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.
Figure 84 Export Test Types process
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15 Customization A customization tool is available to customers in the form of an application/ wizard that enables a user to create, load or cave a “Customization Profile”. This file is encrypted on saving and loading for content protection. An admin user of the T16-ISO Instrument and Desktop Application may wish to configure the app for end users. This may require the restriction of some Application functions and configurable settings to simplify its use. The customization described here operates only on the computer in which the Axxin T16-ISO Desktop Application has been installed on. The T16-ISO Desktop Application will then be shipped containing the desired “Customization Profile” and the installer will not be operational without the presence of this file. Particular configuration lines that can be added to this file can restrict access to pages, results displayed and other specific application items. Additionally the Admin user can replace the logo file and the user manual file in the distribution file directory.
15.1
Customization Tool Description
The customization tool is a single screen application that provides different configurable settings and input fields that can be saved and compiled as an .Iso Profile file to customize the appearance and operation of the T16 Desktop Application.
Figure 85 T16 Customization Tool
NOTE 25.
To change the customisation profile applied to the T16-ISO desktop application, the program must be reinstalled OR save a new customisation profile over the existing file in the program files folder
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(Default C:\Program Files\Axxin\Axxin T16 ISO Desktop\T16Profile.IsoProfile, for Windows 64 bit systems replace "Program Files" with "Program Files (x86)"). NOTE 26.
Image files and PDF help file are embedded into customization profile. Changing the original files will not change appearance of customization profile.
NOTE 27.
If the Customization File is not found when opening the T16-ISO Desktop Application, the following Error Message is displayed:
Figure 86 Error screen: Customization file not found or corrupted
15.2
Icons
ICON
FUNCTIONALITY Create a new profile by configuring the default profile settings Open an existing profile to edit or clone Save the currently configured profile Information about the T16 Customization tool
15.3
Profile Name
Enter a name for the customization profile for ease of identification. Enter the “desktop application titlebar text”, this is effectively the name of the application.
Figure 87 Profile Name Interface
The desktop application title bar text will be displayed in the top left hand corner of the application window next to the application icon.
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Figure 88 Screenshot of the Desktop Application title bar text location
15.4
Desktop Settings
In the Desktop Settings section particular items checked/unchecked can restrict access to pages, results displayed and other specific application items.
Figure 89 Screenshot of the Desktop Settings Checkboxes
ITEM Show Test Types page
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DESCRIPTION CHECKED / UNCHECKED Will show / hide the entirety of the Test Types Page.
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ITEM
DESCRIPTION CHECKED / UNCHECKED
Show Algorithm page
Will show / hide the entirety of the Algorithm Page.
Show Overview page
Will show / hide the entirety of the Overview page. NOTE 28.
This item is linked to “Enable Dual Connections”. If “Enable Dual Connections” is un-checked, “Show Overview Page” must be un-checked when saving the customization file. If “Enable Dual Connections” is checked, “Show Overview Page” may be checked or un-checked when saving the customization file.
Show Instrument Tab
Will show/hide the Instrument tab
Show Sync Tab
Will show/hide the sync tab
Show All Tubes Result view
Will show / hide the “All Tubes” 16 Graph display on the Home page.
Show Results Summary view
Will show / hide the “Results” summary display on the Home page.
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ITEM
DESCRIPTION CHECKED / UNCHECKED
Show Individual Tube graph views
Will show / hide the “Tube 1” to “Tube 16” individual tube results on the Home page..
Show Tube Overlay graph view
Will show / hide the “Tube Overlay” Graph display on the Home page.
Show Temperature graph view
Will show / hide the “Temperature” Graph display on the Home page.
Show Graph Derivative buttons
Will show / hide the ability to configure the graph views for 1st, 2nd derivatives on the Home page.
Static size graph heights
Will disable / enable variable y-axis scales on the Home page results graphs. Checking this option sets the maximum y-axis value to 5000.
Show Current Temperature
Will display the test current temperature.
Show Calibration / Normalisation Items
Will hide Default Temp, Temp Offset and Normalize icons and features on the Instrument page.
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ITEM
DESCRIPTION CHECKED / UNCHECKED
Show Result Algorithm further information
Will show / hide the “Tube [x] (Channel [y])” the detailed test information on the Home page.
Show Import Test Types button
Will show / hide the Import Test types Button on the Support page.
Show Export Test Types button
Will show / hide the Export Test types Button on the Support page.
Show Park Optical Head button
Will show / hide the Park Optics button on the Instrument page.
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Un-checking this option limits the “results” button to just graphically displaying the tube results.
Un-checking this option means that the end user will only have access to test types created in the installed version of the T16-ISO Application.
Un-checking this option means that the end user will not be able to export test types created in the installed version of the T16-ISO Application.
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ITEM
DESCRIPTION CHECKED / UNCHECKED
Lock Metadata entry on start run
Checking this option locks test detail entries after the test starts.
Calculate Result on no Sample ID
Checking this option means that results will be calculated only for tubes with sample IDs added prior to testing.
Un-checking this option will allow the user to edit Sample IDs prior, during and after a test run.
Un-checking this option means that that results are calculated for all tubes.
Use Lid detection on start test
Checking this option means that the T16-ISO lid must be closed to start test. Un-checking this option allows the user to run a test on the T16-ISO Instrument without closing the instrument lid.
Enable Algorithm Channel 2 Results
Will show / hide the channel two Algorithm Results in the Home page results display.
Enable Dual Connections
Will enable / disable dual connections.
Show instrument personalize button
Allow customer to personalize a T16 instrument
Show instrument self test button
Allow customer to run an instrument self-test
Enable Sync incoming connections funtion
Permit a sync ‘server’ to be configured.
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Un-checking this option allows only one instrument connection at a time.
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Figure 90 Example of Full (Unrestricted) T16-ISO Desktop Application
Figure 91 Example of Customized Results Screen, with functionality removed in T16-ISO Desktop Application
15.5
Reports
Choose headings for printed or exported test reports.
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Three types of test results can be exported from the T16 Desktop Application as printed reports. The header block of these documents is customizable.
Figure 92 Reposts, Header Editing Text Fields
Figure 93 Example of Summary Report heading
Figure 94 Example of Graph Report heading
15.6
Software Help File
Choose PDF file to view on desktop Support page e.g. User Manual. Maximum size 4MB.
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Figure 95 Loading the Help File .pdf
Figure 96 Screenshot of User Manual displayed within the T16 Desktop Application
15.7
Desktop Graphics
Figure 97 Screenshot of the Desktop Graphics Customization Tool
Application Icon: Appears in far left of title bar and requires a 64 x 64 pixel ICO file (image file format for computer icons in Microsoft Windows).
Figure 98 Application Icon (ICO)
Application Logo: Appears in various locations including About screen and requires a 147 x 70 pixel PNG image file with transparent background.
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Figure 99 Application Logo (PNG)
Menu Bar Logo: Appears in far right of menu bar and requires a 66 x 28 pixel PNG image file with transparent background suitable for use on dark grey background e.g. white text.
Figure 100
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Menu Bar Icon
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GRAPHIC SPECIFICATIONS Item
Size
Resolution
File Type
Recommendation
Application Icon
64 x 64 px
72 dpi
.ico
Transparent Background
Application Icon
147 x 70 px
72 dpi
.png
Transparent Background
Menu Bar Logo
66 x 28 px
72 dpi
.png
Transparent Background
Example
Bellow is an example of the images implemented in the application:
Figure 101
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Example of Application Icons
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15.8
Instrument Graphics
Instrument Startup Logo: Appears during the instrument start up sequence and requires a 320 x 240 pixel PNG image file with a black background.
Instrument Help Screen Logo: Appears on the instrument Help Screen and requires a 320 x 155 pixel PNG image file with a black background. GRAPHIC SPECIFICATIONS Item
Size
Resolution
File Type
Recommendation
Start Up Image
320 x 155 px
72 dpi
.png
Black Background
15.9
Open
Open an existing customization profile (.ISOPROFILE) to view or edit. By default, T16-ISO Desktop program files including customization profiles are located at C:\Program Files\Axxin\Axxin T16-ISO Desktop NOTE 29.
For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
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Figure 102
Open existing customization profile
15.10 Save As Save a new customization profile. To replace the customization profile currently installed on the T16ISO desktop application, save as the same file name and replace existing file. NOTE 30.
Please note that this action cannot be undone.
Figure 103
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Save as new customization profile
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15.11 About
Figure 104
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Customization Tool About screen
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16 Instrument Specifications Number of Tubes
Configured for up to 16 tubes
Assays
Supports a test types defined on the AX-ISO Desktop application
Measurement Technology Fluorescent - 3 Channel: FAMTM, HEXTM, ROXTM Color Touch Screen 3.5”
Simple workflow management Ease of use; Color icon driver menus and prompts.
Communications
Cable Ethernet for Data Transfer. USB Port for data export, barcode reader and printer Mini USB Port for Laptop connection
Data storage
Up to 99 results (configurable)
Power
12 V DC from external AC/DC supplied plug pack. Battery power (optional). DC Voltage fluctuation ±10% DC Current consumption: 12V DC, 3.0 Amps
Dimensions
380 mm (L) x 122 mm (W) x 139 mm (H) 14.0” (L) x 4.8” (W) x 5.4” (H)
Weight
1.95 kg 4.1 lb
Lifetime
3 year calibration life 5 year instrument life
Printers
Postscript 3 network printer
Operating Environment
Indoor Use 10ºC to 30ºC. 10% to 70% RH (non-condensing). 0 to 2000m altitude. Pressure 0.763 bar (2000m) to 1.01 bar (sea level) Pollution category 2 Minimum light conditions of 100 LUX. Maximum light intensity of 5,000 LUX.
Storage Environment
0ºC to 45ºC, 20% to 70% RH (non-condensing) for at least 7 days. Pressure 0.763 to 1.01 bar. 0 to 2000m altitude. Maximum duration 1 month (cumulative)
Cleaning
Isopropyl Alcohol (IPA) or 10% bleach solution, on a damp, lint free wipe. (No free liquid)
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17 12V Power Supply Adaptor Specifications The T16-ISO Instrument is operated using only the specified and supplied AC/DC power adaptor to ensure both the EMC and safety compliance of the product. The Axxin supplied power adapter, 12V DC, 3.5 Amps: Part Number: PC003354 Description: Power adapter input (100 - 240V AC~50/60 Hz, 1.2A), output (DC 12V, 3.5A) Approval UL'CE; C-Tick; FCC and PSE 4 types plug can fit Australia type; UK type; US (Europe) type and China type. Rated input voltage
100-240VAC
Rated input frequency
50/60Hz
Rated input current
0.4A max.
Operating Environment
0ºC to 40ºC. 10% to 80% RH (non-condensing).
Storage Environment
-20ºC to 80ºC. 10% to 90% RH (non-condensing).
Output voltage
12 V
Output current:
3.5 Amps
The Axxin supplied power adapter (PC003354) is compliant with the following standards: ARCANUM
COUNTRY
CERTIFIED STATUS
STANDARD
UL
USA
MEET
UL 60950-1
CSA
Canada
MEET
CSA C22.2 NO.950
TUV
Europe
MEET
TUV/VDE-EN60950-1
CE
Europe
MEET
Declared& CE Mark
PSE
Japan
/
J60950(H19)/J55001(H14)
BSMI
Taiwan
/
CNS13438
CCC
CHINA
/
GB4943-2001
UK
Britain
MEET
EN60950-1:2000
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18 Uninstall the Application It is recommended that any previous versions of the desktop software be uninstalled from the computer before attempting a new desktop software install. It is also recommended that the user delete any remaining Application files from the Computer Program Files folder before update is installed. UNINSTALLING DESKTOP SOFTWARE
Navigate to Control Panel\All Control Panel Items\Programs and Features
Find Axxin in the list of Publishers. Select T16-ISO Desktop from list and uninstall.
Follow prompts to complete installation.
Navigate to C:\Program Files\Axxin
Delete folder titled: T16-ISO Desktop
NOTE 31.
For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
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19 Troubleshooting 19.1
Cleaning
The T16-ISO Instrument can be cleaned using a lint free wipe, damp with Isopropyl Alcohol (IPA) or 10% bleach solution. Axxin advices to avoid using free liquids to clean the instrument.
19.2
Software Issue Reporting
It may be possible that if you are seeing a software issue on the instrument application or on the desktop software and it is occurring across more than one product; you may have found a software defect or "bug". This user manual contains copies of the following forms that can be used for directly reporting a software defect:
Axxin T16-ISO Instrument Issue: D003453 Form, T16-ISO Support Form, Axxin Instrument Platform
T16-ISO Desktop Application SW Issue: D004045 Form, T16-ISO Desktop Software Support Form, Axxin Instrument Platform
Axxin recommends completing the above mentioned forms and supplying them to Axxin via
[email protected]. The forms are also available on Axxin web site at www.axxin.com/support Some things to consider when reporting a software defect or bug:
Make sure your software is up to date.
Take note of what steps you performed to cause the defect to occur. Steps to reproduce are the most important part of any defect report. If Axxin is able to reproduce the defect, the defect can be investigated. If the steps are unclear, it might not even be possible for Axxin to replicate the issue that you have found.
What where you expecting to see "expected result" and what happened instead "actual result"?
If you are seeing an Error or Warning dialogue, please let us know the Error Code number "0000" which can be found on the top line of the dialogue screen.
Take note if the issue is accruing on the instrument application or on the desktop software.
Take note of how many instruments are affected.
Take note of how frequently you are seeing the defect.
Take note of what hardware is connected to the instrument such as printers, barcode scanners, USBs or to a desktop computer via a network connection.
If you believe you are seeing multiple defects on the same instrument, please fill separate support forms per defect, rather than by instrument.
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Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
400 Continental Blvd, 6th Floor, El Segundo CA, 90245 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
Thank you for completing this form. Please send your response to
[email protected] T16-ISO SUPPORT FORM Company: Name: Position: Email: T16-ISO INSTRUMENT The Instrument Serial Number and Revision Number is located on a label on the back side of the instrument. Look for the serial number format: S00XXXX and revision number R1, R2, R3
Instrument Serial Number/s: Revision Number: If you are able to access the instrument application screens, navigate to: Settings/About/. You will find the entire instrument Software, Firmware and Hardware information here.
Instrument Application Version x.x.x.x:
In your own words describe what the problem is. On which screen you were looking at when the error occurred and if any USB instruments such as a USB Memory key or Printer Attached. How frequently are you seeing the issue?
Description of Fault:
Please supply the instrument log file as an attachment. Attach a USB Flash Memory Key to the T16-ISO Instrument. If you are able to access the instrument application screens, navigate to: Setting/ Administrator Setting/Enter Admin Password/Import and Export Functions/Export Logfile to USB This export the instrument “Logfile” to an attached USB Flash Memory Key. Please attach the instrument log file to this email. Refer to the Instrument User Manual D003643 Import and Export Functions section for further information.
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Australian Office
USA Office
UK Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia T + 61 3 9329 1167 F + 61 3 8732 0310 ABN 43 120 905 839
400 Continental Blvd, 6th Floor, El Segundo CA, 90245 USA T + 1 858 736 9160 F + 1 858 346 9300
45 King William Street London, United Kingdom EC4R 9AN T + 44 203 714 5650 www.axxin.com Commercial in Confidence
Thank you for completing this form. Please send your response to
[email protected] T16-ISO Desktop Support Form Company: Name: Position: Email: T16-ISO DESKTOP SOFTWARE
NOTES Check the Desktop Software version number, go to:
Desktop software version:
T16 ISO Desktop Application/ Support/ About
Software Version of connected instrument:
If you are able to access the instrument application screens navigate to the instrument information/about screen. You will find the entire instrument Software, Firmware and Hardware information here. Instrument Application Version x.x.x.x
What Windows Operating System were you using?
To find your system specification go to:
E.g. Windows 7 or 8, 32 bit or 64 bit?
Record the Windows edition and the System type
How were you connected to the instrument?
Using a network cable and connecting via Ethernet direct adhoc connection or via Local Area Connection?
Control Panel\All Control Panel Items\System
Or where you using a USB Cable to connect?
Description of Fault:
In your own words describe what the problem is. On which screen you were looking at when the error occurred? At what stage does the problem occur? (E.g. on connection, temperature warm-up, test run?) How frequent is the problem? (E.g. intermittent - every few tests? Does the test run ever finish or does it always crash before this?).
Are you able to take a screen shot of the error? If so please attach. If you are looking at the fault on screen, or are seeing an error message you could take a screen shot of what you see. Hold down the "Alt" key and press "Print Screen" And either attach or copy past the image into this email.
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Please perform a self test on the Desktop Software. Please send us a copy of Self Test output file, conducted on the instrument with the issue. Go to T16 ISO Desktop Application/ Instrument/ Self Test, run a Self Test and save the test result JSON file and attach it to this email. Refer to the Desktop User Manual D003468 for further information. If you cannot access the self test, a log file can be found at C:\Program Files\Axxin\Axxin T16 ISO Desktop\Logs. For Windows 64 bit systems replace "Program Files" with "Program Files (x86)"
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20 Warranty & End User License Agreement The software is warranted against defects in materials and workmanship for a period of one (1) year. For specific warranty information, contact the Axxin office in your country. If any defects should occur during the warranty period, Axxin will replace the defective parts without charge. However, the following defects are specifically excluded:
Defects caused by improper operation or by improper packaging of returned goods.
Repair or modifications done by anyone other than Axxin Pty. Ltd.
Use with tubes, or materials not specified by Axxin Pty. Ltd.
Deliberate or accidental misuse.
Damage caused by disaster.
Damage due to use of improper solvent or sample.
The warranty does not apply to fuses. For inquiry or request for repair service, contact Axxin after confirming the model and unique silicon chip serial number of your instrument.
20.1
Limitations
This is a prototype system for use in research, development and investigation. No guarantee or warranty, express or implied is provided for the operation and use of this equipment. This system of instrument & software is provided solely for use as an experimental instrument for research applications and is not approved for any diagnostic or medical applications. In no event shall licensor or its suppliers be liable to you or any third party for any special, incidental, indirect or consequential damages of any kind, or any damages whatsoever, including, without limitation, those resulting from loss of use, data or profits, whether or not licensor had been advised of the possibility of such damages, and on any theory of liability, arising out of or in connection with the use of the licensed works. Some jurisdictions prohibit the exclusion or limitation of liability for consequential or incidental damages, so the above limitations may not apply to you. These limitations shall apply notwithstanding any failure of essential purpose of any limited remedy.
20.2
Design Life and Updates
This instrument is intended for desktop research only, and has a design life of five years. After this period, the equipment must be decommissioned and not used, or specifically evaluated for any further application or extension of life and support. Axxin Pty. Ltd. reserves the right to issue a “change notice” relating to the construction, software or use of the instrument at any time. The instrument must be quarantined from use immediately after a change notice is issued and until the update is completed.
20.3
Instrument Failure and Errors
The instrument and its associated software are constructed using standard components and methods. The instrument and the software can fail or provide incorrect readings or result in error. These risks should be considered by the intended user and where applicable mitigated by other methods independent of the Axxin supplied equipment, such as:
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Warnings
Use of other indicators or readings.
Secondary, independent, testing or measurement.
20.4
General Notice
The Axxin instrument is intended as a general-purpose instrument for research use. No claim or representation is intended for their use to identify any specific organism or for a specific clinical use (diagnostic, prognostic, therapeutic or blood banking). It is the user’s responsibility to validate the performance of Axxin instruments and kits for any particular use, since their performance characteristics have not been validated for any specific use. 20.5
Licensing and Third Party Intellectual Property
The Axxin Instrument is a general purpose instrument and can run many different types of chemistry, assays and test types. It is the responsibility of the user to ensure they have acquired the applicable licenses or rights to use the intellectual property of others for a specific test protocol, reading protocol, chemistry, assay or test type. The requirements may vary by the intended test type applicator, region chemistry or applied test result method used.
20.6
Intended Use
This instrument is supplied for research testing and is not an IVD instrument suitable or intended for use in clinical or human health applications. Where reliance on the test result, even for research is important, additional independent tests or indicators must be used. Axxin does not accept any consequent loss that would arise in relying on the readings of the Axxin instrument alone. 20.7
End-User License Agreement
CAREFULLY READ THE FOLLOWING TERMS AND CONDITIONS BEFORE USING THIS PRODUCT. IT CONTAINS SOFTWARE, THE USE OF WHICH IS LICENSED BY AXXIN PTY LTD (ACN 120 905 839), TO ITS CUSTOMERS FOR THEIR USE ONLY AS SET FORTH BELOW. IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, DO NOT USE THE SOFTWARE. USING ANY PART OF THE SOFTWARE INDICATES THAT YOU ACCEPT THESE TERMS. GRANT OF LICENSE: Axxin Pty Ltd, Inc. (the "Licensor") grants to you this personal, limited, nonexclusive, non-transferable, non-assignable license solely to use in a single copy of the Licensed Works on a single computer for use by a single concurrent user only and solely provided that you adhere to all of the terms and conditions of this Agreement. The foregoing is an express limited use license and not an assignment, sale, or other transfer of the Licensed Works or any Intellectual Property Rights of Licensor. ASSENT: By opening the file containing this software, you agree that this Agreement is a legally binding and valid contract, agree to abide by the intellectual property laws and all of the terms and conditions of this Agreement, and further agree to take all necessary steps to ensure that the terms and conditions of this Agreement are not violated by any person or entity under your control or in your service.
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OWNERSHIP OF SOFTWARE: The Licensor and/or its affiliates or subsidiaries own certain rights that may exist from time to time in this or any other jurisdiction, whether foreign or domestic, under patent law, copyright law, publicity rights law, moral rights law, trade secret law, trademark law, unfair competition law or other similar protections, regardless of whether or not such rights or protections are registered or perfected (the "Intellectual Property Rights"), in the computer software and hardware, together with any related documentation (including design, systems and user) and other materials for use in connection with such computer software in this package (collectively, the "Licensed Works"). ALL INTELLECTUAL PROPERTY RIGHTS IN AND TO THE LICENSED WORKS ARE AND SHALL REMAIN IN LICENSOR. NO COMMERCIAL USE: This License Agreement grants you the right to use the Software for solely for the intended use with Axxin products. PRODUCT ACTIVATION: Your use of the Software is governed by product activation technology that limits the number of installations and total number of computers on which the Software. This product activation technology may not be circumvented or otherwise disabled in any way.
20.8
Restrictions
(a) You are expressly prohibited from copying, modifying, merging, selling, leasing, redistributing, assigning, or transferring in any matter, Licensed Works or any portion thereof. (b) You may take a single copy of materials within the package or otherwise related to Licensed Works only as required for backup purposes. (c) You are also expressly prohibited from reverse engineering, decompiling, translating, disassembling, deciphering, decrypting, or otherwise attempting to discover the source code of the Licensed Works as the Licensed Works contain proprietary material of Licensor. You may not otherwise modify, alter, adapt, port, or merge the Licensed Works. (d) You may not remove, alter, deface, overprint or otherwise obscure Licensor patent, trademark, service mark or copyright notices. (e) You agree that the Licensed Works will not be shipped, transferred or exported into any other country, or used in any manner prohibited by any government agency or any export laws, restrictions or regulations. (f) You may not publish or distribute in any form of electronic or printed communication the materials within or otherwise related to Licensed Works, including but not limited to the object code, documentation, help files, examples, and benchmarks. TERM: This Agreement is effective until terminated. You may terminate this Agreement at any time by uninstalling the Licensed Works and destroying all copies of the Licensed Works. Upon any termination, you agree to uninstall the Licensed Works and return or destroy all copies of the Licensed Works, any accompanying documentation, and all other associated materials.
20.9
Warranties and Disclaimer
EXCEPT AS EXPRESSLY PROVIDED OTHERWISE IN A WRITTEN AGREEMENT BETWEEN LICENSOR AND YOU, THE LICENSED WORKS ARE NOW PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THE WARRANTY OF NON-INFRINGEMENT. WITHOUT LIMITING THE FOREGOING, LICENSOR MAKES NO WARRANTY THAT (i) THE LICENSED WORKS WILL MEET
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YOUR REQUIREMENTS, (ii) THE USE OF THE LICENSED WORKS WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE, (iii) THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE LICENSED WORKS WILL BE ACCURATE OR RELIABLE, (iv) THE QUALITY OF THE LICENSED WORKS WILL MEET YOUR EXPECTATIONS, (v) ANY ERRORS IN THE LICENSED WORKS WILL BE CORRECTED, AND/OR (vi) YOU MAY USE, PRACTICE, EXECUTE, OR ACCESS THE LICENSED WORKS WITHOUT VIOLATING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. SOME STATES OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES OR LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY MAY LAST, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. IF CALIFORNIA LAW IS NOT HELD TO APPLY TO THIS AGREEMENT FOR ANY REASON, THEN IN JURISDICTIONS WHERE WARRANTIES, GUARANTEES, REPRESENTATIONS, AND/OR CONDITIONS OF ANY TYPE MAY NOT BE DISCLAIMED, ANY SUCH WARRANTY, GUARANTEE, REPRESENTATION AND/OR WARRANTY IS: (1) HEREBY LIMITED TO THE PERIOD OF EITHER (A) THIRTY (30) DAYS FROM THE DATE OF OPENING THE PACKAGE CONTAINING THE LICENSED WORKS OR (B) THE SHORTEST PERIOD ALLOWED BY LAW IN THE APPLICABLE JURISDICTION IF A THIRTY (30) DAY LIMITATION WOULD BE UNENFORCEABLE; AND (2) LICENSORS SOLE LIABILITY FOR ANY BREACH OF ANY SUCH WARRANTY, GUARANTEE, REPRESENTATION, AND/OR CONDITION SHALL BE TO PROVIDE YOU WITH A NEW COPY OF THE LICENSED WORKS. IN NO EVENT SHALL LICENSOR OR ITS SUPPLIERS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, OR ANY DAMAGES WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THOSE RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER OR NOT LICENSOR HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND ON ANY THEORY OF LIABILITY, ARISING OUT OF OR IN CONNECTION WITH THE USE OF THE LICENSED WORKS. SOME JURISDICTIONS PROHIBIT THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. SEVERABILITY: In the event any provision of this License Agreement is found to be invalid, illegal or unenforceable, the validity, legality and enforceability of any of the remaining provisions shall not in any way be affected or impaired and a valid, legal and enforceable provision of similar intent and economic impact shall be substituted therefore. ENTIRE AGREEMENT: This License Agreement sets forth the entire understanding and agreement between you and Licensor, supersedes all prior agreements, whether written or oral, with respect to the Software, and may be amended only in a writing signed by both parties.
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