User Manual T16-Isothermal Instrument Stand Alone Mode
© 2013 - 2017 Axxin Pty Ltd All Rights Reserved. Commercial in Confidence D003643 Version 3.2
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
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
DOCUMENT CONTROL DETAILS
TITLE DOC No. CUSTOMER CONTACT
User Manual, Stand Alone Instrument, Axxin T16-ISO D003643
Axxin Internal
DOCUMENT APPROVAL POSITION
NAME
SIGNATURE
TECHNICAL DIRECTOR
Bill Hopper
SOFTWARE IMPLEMENTATION MANAGER
Daniel Murawczuk
DATE
REVISION HISTORY NO.
REVISION DESCRIPTION
AUTHOR
DATE
NKJ
24 Feb 2017
3.2
Updated for Release 21 Instrument Software: v2.1.0.2-466 Desktop Software: v2.1.0.2-409
3.1
Updated for software release version 1.8.1.3
IW
19 Aug 2015
3
Updated for software release version 1.8.X.X
KSW
13 Mar 2015
Address Update
CCH
07 Jan 2015
Addition of CE and WEEE declarations Update to document template
CCH
26 May 2014
1.5
Minor Screen Updates
CCH
28 Mar 2013
1.4
Updated following 1.5.1.0 Software Release
CCH
27 Sep 2012
1.3
Typo Update
CCH
28 Aug 2012
1.2
Cleaning Instructions Added
CCH
24 Aug 2012
1.1
Updated following internal Review
CCH
03 Aug 2012
Initial Release
CCH
14 May 2012
2.1 2
1
NOTE: Latest version is first.
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Contents 1 General Information ................................................................................................................................................................. 5 1.1
Warnings & Limitations ................................................................................................................................................ 5
1.2
Safety .......................................................................................................................................................................... 6
1.3
Copyright ..................................................................................................................................................................... 7
2 Introduction.............................................................................................................................................................................. 8 2.1
Intended Use ............................................................................................................................................................... 8
2.2
Contact Information – Axxin Pty Ltd ............................................................................................................................. 9
2.3
Conventions ................................................................................................................................................................. 9
2.4
Abbreviations ............................................................................................................................................................. 10
2.5
System Components.................................................................................................................................................. 11
2.6
Instrument Overview .................................................................................................................................................. 11
2.7
Power Button ............................................................................................................................................................. 12
2.8
Front LED Status Indicator ......................................................................................................................................... 12
2.9
External Connectors .................................................................................................................................................. 12
2.10
Labels ....................................................................................................................................................................... 13
2.11
Lysis Tubes ............................................................................................................................................................... 14
3 Setup Guide .......................................................................................................................................................................... 15 4 Instrument Software .............................................................................................................................................................. 16 4.1
Menu Structure .......................................................................................................................................................... 16
4.2
Home Menu ............................................................................................................................................................... 17
4.3
Navigation Icons ........................................................................................................................................................ 17
4.4
Function Icons ........................................................................................................................................................... 17
4.5
Menu Icons ................................................................................................................................................................ 18
4.6
System Keyboard and Keypad ................................................................................................................................... 18
4.7
User Types ................................................................................................................................................................ 18
4.7.1
Standard User..................................................................................................................................................... 18
4.7.2
Admin User ......................................................................................................................................................... 19
4.7.3
Factory User ....................................................................................................................................................... 19
5 Run Test.............................................................................................................................................................................. 20 5.1
Completed Test Results ............................................................................................................................................. 22
5.2
Completed Test Saved............................................................................................................................................... 23
6 Test Result History ............................................................................................................................................................... 24 7 Settings ................................................................................................................................................................................ 26 7.1
About this device ....................................................................................................................................................... 26
7.2
Help Information ........................................................................................................................................................ 27
7.3
Audio ......................................................................................................................................................................... 27
7.4
Brightness.................................................................................................................................................................. 27
7.5
Printer Setup .............................................................................................................................................................. 28
7.6
Remote Mode ............................................................................................................................................................ 28
8 Administrator Settings PASSWORD ACCESS .................................................................................................................................... 29 8.1
Time & Date ............................................................................................................................................................... 29
8.2
Network Setup ........................................................................................................................................................... 30
8.3
Import and Export Functions ...................................................................................................................................... 30
8.3.1
Export Test Results............................................................................................................................................. 30
8.3.2
Exporting Device Log .......................................................................................................................................... 31
8.3.3
Importing Test Types .......................................................................................................................................... 31
8.3.4
Importing Customization Profiles ......................................................................................................................... 31
8.4
Park Optics Head FOR SERVICE USE ONLY ........................................................................................................................... 31
8.5
Reset to Factory Default FOR SERVICE USE ONLY ................................................................................................................. 32
8.6
Factory Settings PASSWORD ACCESS ................................................................................................................................. 32
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9 Error, Warning and Information Screens ................................................................................................................................ 33 10
Update Software .............................................................................................................................................................. 34
11
Uninstall Software............................................................................................................................................................ 35
12
Data Export and Archive .................................................................................................................................................. 36 12.1
Saved Results ........................................................................................................................................................... 36
12.2
Published Data Interface ........................................................................................................................................... 36
13
T16-ISO instrument Specifications................................................................................................................................... 38
14
12V Power Supply Adaptor Specifications ....................................................................................................................... 39
15
16 17
Accessories ..................................................................................................................................................................... 40 15.1
USB key .................................................................................................................................................................... 40
15.2
Network Printer ......................................................................................................................................................... 40
15.3
Barcode Scanner ...................................................................................................................................................... 41
Cleaning & Decontamination ........................................................................................................................................... 42 Service & Maintenance .................................................................................................................................................... 43 17.1
Software Issue Reporting .......................................................................................................................................... 43
17.2
Service & Repair Procedure ...................................................................................................................................... 46
17.3
Return for Service Request ....................................................................................................................................... 47
17.3.1 Quote for Services .............................................................................................................................................. 48 18
CE Declaration ................................................................................................................................................................ 50
19
RoHS Declaration ............................................................................................................................................................ 51
20
WEEE Directive Declaration ............................................................................................................................................ 52
21
Warranty & End User License Agreement ....................................................................................................................... 53 21.1
Limitations................................................................................................................................................................. 53
21.2
Design Life and Updates ........................................................................................................................................... 53
21.3
Instrument Failure and Errors .................................................................................................................................... 53
21.4
General Notice .......................................................................................................................................................... 54
21.5
Licensing and Third Party Intellectual Property .......................................................................................................... 54
21.6
Intended Use............................................................................................................................................................. 54
21.7
End-User License Agreement ................................................................................................................................... 54
21.8
Restrictions ............................................................................................................................................................... 55
21.9
Warranties and Disclaimer ........................................................................................................................................ 56
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1
General Information 1.1
Warnings & Limitations Warning: Hot Surfaces. The heater block in this T16-ISO instrument operates at up to 65˚C and may cause contact burns or damage to materials in contact with these areas. Warning: This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. Warning: Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with proper operation. 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 approved, listed peripheral accessories with the T16-ISO instrument. Warning: Do not use this T16-ISO 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 T16-ISO instrument the total length should not exceed 3.0 metres. Warning: Maximum current supplied by all USB peripherals should not exceed 1.1A (2 High power Loads and 1 Low power Load). Warning: This T16-ISO 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 T16-ISO 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.
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Warning: Do not open or attempt to repair the T16-ISO instrument or other accessories as there is a risk of damage to the T16-ISO instrument. This T16-ISO instrument does not contain serviceable parts and should be returned to the supplier for repair. Opening the T16-ISO 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. Warning: Only operate the T16-ISO 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 T16-ISO 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 T16-ISO instrument with clear access to connectors. Keep connected cables clear of work areas such that tripping or catching will not pull the T16ISO 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. If intended for connection to external equipment, please ensure that interfaces of such equipment are separated from mains by double reinforced insulation and present no risk of electrical shock. NOTE 1.
1.2
Failure to follow these warnings will void the T16-ISO instrument warranty.
Safety
The T16-ISO instrument is intended to provide safe and reliable operation when used in accordance to this User Manual. If the T16-ISO 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 T16-ISO instrument on a stable, level bench, in an office or laboratory environment. The T16-ISO instrument is not intended as a hand held T16-ISO instrument, only operate it on a flat and level surface. Install the T16-ISO instrument at least 100mm minimum form any edge. Install cables so as to prevent risk of tripping or pull that may cause T16-ISO instrument or personal injury. The T16-ISO instrument is a non serviceable part, opening the T16-ISO instrument will void the T16-ISO instrument warranty.
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1.3
Copyright
© 2013 - 2015 Axxin Pty. Ltd. All Rights Reserved. This manual, as well as the hardware 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. This document is provided as an operational summary to describe the use of the T16-ISO instrument. This document does not describe operation of the specific diagnostic test or provide any input to the requirements, safety or processing of the diagnostic test which is outside of the scope of Axxin Pty Ltd. 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 — also referred to as "the T16-ISO device". Axxin’s advanced T16-ISO isothermal instrument operates at constant temperature and enables the next generation of diagnostic DNA/RNA amplification in a compact, low cost, stand alone, sensitive instrument suitable for field based and point of care diagnostic applications. The T16-ISO Instrument is a portable, research instrument that provides measurement of three fluorophores; FAMTM, HEXTM and ROXTM. This instrument is intended for research and development use only and is not intended for any diagnostic or medical use. The T16-ISO instrument developed as part of a larger diagnostic system including an assay and specific test instructions for diagnostic applications and should not be considered in isolation. If the intended use carries risks of injury or death additional tests or indicators must be considered The T16-ISO Instrument that works in conjunction with the T16-ISO Desktop application. The T16-ISO instrument complies with the emissions and immunity requirements of the following standards IEC 61326-1 (complying with Immunity test requirements for equipment intended for use in industrial locations) and IEC 61326-2-6. NOTE 2.
Refer to the CE Declaration, a copy of which has been provided in the rear of this manual.
This equipment has been tested and found compliant with emissions limits required by CISPR11 Class A equipment. This T16-ISO instrument complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this T16-ISO instrument may not cause harmful interference, and (2) this T16-ISO instrument must accept any interference received, including interference that may cause undesired operation. Where Axxin is the importer and distributer, the product has WEEE registration for the UK and specific other countries as required. NOTE 3.
Refer to the WEEE Declaration, a copy of which has been provided in the rear of this manual.
NOTE 4.
The Axxin T16-ISO device is RoHS compliant. Please refer to RoHS Declaration, a copy of which has been provided in the rear of this manual.
Axxin advises the user to assess the electromagnetic environment of the intended operational environment of the T16-ISO instrument prior to use. Key features of the T16-ISO instrument include multiplexing support, automated workflow management, colour touch screen, networking and communication options.
2.1
Intended Use
This T16-ISO 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 T16-ISO 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 the scope of Axxin Pty Ltd.
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NOTE 5.
It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to the customer or user.
NOTE 6.
It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the T16-ISO instrument will perform as intended.
NOTE 7.
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 radiates 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. • Consult the dealer or an experienced radio/TV technician for help.
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
Conventions
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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
D003643v3.2 User Manual, Instrument Stand Alone Mode, Axxin T16-ISO.docx
NOTE
2.4
Information
Critical information relating to procedures or use.
Abbreviations
ID
Identification
LCD
Liquid Crystal Display
LED
Light-Emitting Diode
PC
Personal Computer
PCB
Printed Circuit Board
USB
Universal Serial Bus
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2.5
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
System Components
The following system components are supplied with the T16-ISO instrument:
2.6
T16-ISO instrument. Power supply.
Instrument Overview
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
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Fluorophore Module System - Replaceable Module - 3 Channels
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2.7
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.
2.8
Front LED Status Indicator
The Front LED provides approximate confirmation that temperature is close to the requirements for a test as a general status guide to a user. Currently the software will not start a test until the “at temperature” flag is set by the instrument firmware. STATUS
DESCRIPTION
Solid Green
Heater is at temperature (±1°C)
Flashing Orange
Heater is not at temperature (outside ±1.0°C)
Flashing Red
Hardware fault is detected.
Flashing Red 5Hz
Factory use only: Instrument is running in bootloader firmware rescue mode.
2.9
External Connectors
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2.10 Labels
LABEL
DESCRIPTION
Axxin PTY LTD logo
CE Mark
Restriction of Hazardous Substances Compliant WEEE Directive Compliance Where Axxin is the importer and distributer, the product has WEEE registration for the UK and specific other countries as required. FFC Rules Biological hazards Also known as biohazards: Potential contamination of biological substances that pose a threat to the health. Australian Regulatory Compliance Mark (RCM) E1372 is the Axxin PTY LTD manufacture registration number Refer to User Manual
Manufacturer
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2.11 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
Setup Guide T16-ISO instrument UNPACK
Unpack the T16-ISO instrument and set up on a stable, level bench, in a clean office or lab type environment.
Power Supply POWER UP
Configure the power supply for your region. Connect the 12V power supply to the T16-ISO instrument. Ethernet Cable
CONNECT
is required to connect the T16-ISO instrument to a facility network, for network printing and to sync to network date/time settings. Test Package on USB Key
IMPORT
Use a USB key loaded with a Workflow Test Package to import test types onto the T16-ISO instrument. Blank USB Key for Archive
EXPORT
Use a USB key to export test results and instrument data from the T16-ISO instrument. Software Update on USB Key
SOFTWARE UPDATE
Use a USB key loaded with a software update to install the latest software onto the T16-ISO instrument. Power Off/ Standby
POWER DOWN
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It is recommended that the T16-ISO instrument is powered down when not in use. However the instrument will go into a screen saver mode when left on and not in use.
D003643v3.2 User Manual, Instrument Stand Alone Mode, Axxin T16-ISO.docx
4
Instrument Software 4.1
Menu Structure
HOME MENU
TEST TEST RESULTS
VIEW ALL RESULTS SEARCH FILTER GO TO TEST NUMBER
SETTINGS
ABOUT THIS DEVICE HELP INFORMATION AUDIO BRIGHTNESS PRINTER SETUP REMOTE MODE ADMIN SETTINGS
ADMIN PASSWORD ACCESS TIME AND DATE NETWORK IMPORT AND EXPORT PARK OPTICS RESET TO FACTORY DEFAULT FACTORY SETTINGS
FACTORY PASSWORD ACCESS
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4.2
Home Menu
Connect instrument power supply to T16-ISO. The T16-ISO Instrument will start power up sequence once the user engages the power switch. The landing page is the Home Menu. The Home Menu screen provides the following:
Testing History Settings
NOTE 8.
4.3
The time and date is displayed to the user on the main screen. Time and dates is confirmed by the user.
Navigation Icons HOME: Select “Home” to navigate back to the Home Menu screen. This is a faster way to navigate back from one of the lower application screens, for example on completion of setting date/time in the Administrator settings screens. OK: If the Instrument Application requires the user to confirm an input or a settings change the “OK” button will appear. The user must select this button to proceed. CANCEL: In the event that the user wishes to cancel a current action they may do so by selecting the “Cancel” icon. They will be prompted with a dialogue screen requesting a confirmation. The user will be directed back to the previous screen. UP & DOWN ARROWS: Enable navigation, particularly in settings screens to scroll through menus.
RETURN: The ‘Return’ icon jumps back to the previous menu screen.
4.4
Function Icons NEW TEST: Selecting the new test icon will take the user directly to the select test type screen. To enable a rapid workflow of testing. PRINT: Select the print icon on the test result screens to print a report summary for record keeping. GRAPH: Selecting the graph icon displays the data points recorded over time as the assay develops. AUTOFILL: Once a Sample ID is entered for Tube 01, containing a ID ending in a numeric input (for example ABC01), then the “Auto fill” icon will appear. Once selected all other Sample IDs will be filled, auto incrementing by 1.
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4.5
Menu Icons MAIN MENU TESTING TEST RESULTS SETTINGS ADMINISTRATOR SETTINGS FACTORY SETTINGS
4.6
System Keyboard and Keypad
The onscreen Qwerty Keyboard and Numeric Keypad enable user text input into the T16-ISO instrument.
Figure 1 Qwerty Keyboard and Numeric Keypad
4.7 4.7.1
User Types Standard User
The standard user has access to the home menu, testing, result review and basic settings. The standard user can:
Run a test.
Review results.
Print a single result.
Export a single result to an attached USB key.
Can view the T16-ISO instrument "About" information.
Adjust the T16-ISO instruments audio settings.
Configure the LCD screen brightness level.
Setup a printer to work with T16-ISO instrument.
Can review the T16-ISO instrument "Help" information.
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4.7.2
Admin User
There is one admin user role on the T16-ISO instrument. The admin user has access to the same functionality as the standard user as well as access to the "Admin Settings" screens. The admin user can:
Change the time and date.
Setup a network connection to a T16-ISO instrument.
Export test results.
Export the T16-ISO instrument logfile.
Import test types onto the T16-ISO instrument.
Park the optics module for troubleshooting.
Run a self test as required.
Return the T16-ISO instrument to factory default settings.
4.7.3
Factory User
There is one factory user role on the T16-ISO instrument. The factory user has access to the same functionality as the standard user and the admin user as well as access to the "Factory Settings" screens.
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5
Run Test NOTE 9.
In the event that the test cannot be completed due to instrument failure or unexpected power loss, the test result will not be saved.
Select the “Testing” icon on the home screen. Select “Test Type” to view the list of the currently available test types. NOTE 10. To change assigned test type, press the test type button again to make new selection
Select the test type you wish to run from the onscreen test type list. Once an appropriate test has been selected from the list of Test types installed on the T16-ISO Instrument, then select “OK” to navigate to the next test step.
Enter a Test Name The user enters a Test Name as an additional information field as a reference item to search and identify tests at a later date. The test screen indicates which tubes need to be inserted for the assigned Test Type. Where a Tube is not required, an empty (black) tube location is displayed. In this example all 16 tubes are required for testing. Tube locations with no Sample ID entries will remain blank until a Sample ID is entered and saved.
Each tube requires a unique Sample ID. Enter a Sample ID by selecting the tube location from the onscreen graphic and using the onscreen keyboard to input the text field. Select “OK” to save text input. Select “Cancel” to navigate back without saving changes. Sample IDs: If the Test Type requires Sample ID entry this must be done using the Instrument‘s touch screen display prior to testing. If an alpha followed by a numeric sample id is entered, for example ABC00 the information can be auto-filled
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Once all Sample IDs have been entered it is now possible to start the test. Insert the samples into the T16-ISO tube bed. Select “OK” to proceed. Select “Cancel” to cancel current test. NOTE 11. that if the test is cancelled the test number (T#) will not be recorded in the test results and the test number will be used on the next run test. Close Lid: The device lid is required to be closed to initiate the start of a test but once the test workflow has started, lid open and close events will be recorded in test results .JSON file for review. The T16-ISO Instrument will display the current temperature and the test temperature set in the Test Type. Once the Temperature is set the test can begin.
If the Test Type required the Instrument lid to close during test then the instrument will not initiate testing until the lid is closed by the user.
Once the:
sample tubes have been inserted the test name has been entered all desired Sample IDs have been entered the T16-ISO is at temperature and the device lid is closed.
The user is ready to start a test. The “Waiting” workflow item displays the timer countdown in which the sample is held at temperature.
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The “Reading” workflow item indicates that FAM, HEX and ROX readings are being taken for the tubes and the channels selected in the Test Type.
The “Lid Action” workflow item indicates that the lid must be opened and closed before the time out finished. The timeout period and Lid Action Message are set by the test type definition.
5.1
Completed Test Results
The following results are possible for the T16-ISO Instrument tests: Negative Result Positive Result Invalid Result No Sample ID: 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. The Results Summary screen displays the test results for each of the tubes tested. This information can be printed in a test report by selecting the “Print” icon. To start a new test, select the “New Test” icon. On the results screen, touch any tube to see detailed results for that tube.
For a duplex test result, tube results for both channels are displayed. Detailed tube results may be viewed by touching the required tube.
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The detailed results screen shows a graph of the tube readings. Select back to navigate back to the Results Summary screen.
Back on the Results Summary screen, selecting the Report icon provides the following options:
Print Test Result
Export Test Result
Selecting “Print Test Result” prints a test result summary report. The summary report format is set by the Customisation Profile loaded on the instrument. See the Settings section for printer setup. If a USB key is connected to the instrument, selecting “Export Test Result” exports the test result’s JSON and CSV files to the connected USB key. Select the back button to return to the results screen.
5.2
Completed Test Saved
The application automatically saves test results to a location in the T16-ISO Instrument memory. 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 Test Result file name CCEEC413_20120427105101.json can be broken down to: Instrument ID CCEEC413
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_ _
YYYY 2012
MM 04
DD 27
hh 10
mm 51
ss 01
File ext .json
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6
Test Result History The T16-ISO Instrument’s Test Results screen enables the user to search through the test data stored. Such information can be searched via a number of different text fields. Select the “Test Results” icon from the “Home” menu screen. “View all Test Results” will display the full list of test result performed and saved on the instruments internal memory; beginning with the most recently performed test. The user will receive notifications as the instrument memory approaches capacity. The “Search Filter” will enable the user to enter field search for either Test Name, Test Type or Test Number. “Go to Test Number” will allow the user to jump to a particular point in the entire test result list. This method may be most appropriate way to search within the range of the test results in question. “Test Name” allows the user to search through results by Test Name. The Test Name can be entered by using the on screen keypad. “Test Type” allows the user to search through results by the Test Type that was conducted. The test type can be entered by using the on screen keypad. “Test Number” allows the user to search through results by entering the test number. “Sample ID” allows the user to search through results by entering the Sample ID. Users can navigate through different Result Summary screens by using the “Up” and “Down” navigation arrows. A user can select a tube result to view more information about that tube.
Duplex test results will display the tube results from both channels. As with a single channel result, a user can select any of the tube results to view more information about that tube.
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Tube Graph Display
By selecting the “Print” icon from the results screen will display a “Print Test Result” and “Export Test Result”. The print function will print a test report to a network connected printer. Export Test will export the singular test report to an attached USB Flash memory key.
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7
Settings The “Settings” screen is accessed from the Home menu and allows a user to configure the instrument. Use the settings screen to find out information about the T16-ISO device or change/ update device settings, including:
About this device
Help Information
Audio
Brightness
Printer Setup
Remote Mode
Administrator Settings (Password Access)
7.1
About this device
The “About this device” screen gives information about the T16-ISO Instrument Device including:
Instrument Name Instrument ID Application Version IP Address Mac Address OS build Version Kernel Version
NOTE 12. A record of these identifying fields can assist the company in providing support and assistance. This information is also available on the printed report from the instrument. Navigating to the second information screen via arrow displays the following Hardware and Firmware version numbers:
Base Board Tray Board FAM Channel HEX Channel ROX Channel
Navigating to the third information screen via arrow displays the channel normalization values.
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7.2
Help Information
The “Help” screen displays the company contact information, T16-ISO Instrument Serial Number and copyright information. Direct any queries to the company via the website. Select return to view the first information screen.
7.3
Audio
The instrument sound volume can be edited on this screen. The volume can be adjusted from 0 (no sound) to 5 (highest volume). The test icon allows the user to hear what the current settings are. The Instrument uses sound for the following functions:
A click whenever the touch screen is used.
Tones to indicate processes such as the end of a test, alerts, and warnings.
Select the “OK” icon to save changes, or “CANCEL” to return to settings screen.
7.4
Brightness
Use the up and down arrows to set instrument LCD brightness. 50% is the default and recommended device setting. Select the “OK” icon to save changes, or “CANCEL” to return to settings screen.
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7.5
Printer Setup
The user can print a summary of a Test conducted on the T16-ISO instrument to a connected network printer. If the T16-ISO Instrument is connected to the network, the “Find Printers on Network” function can be used to search for printers already setup on the same network. Otherwise a user can search for a printer by entering the printer’s known IP Address.
7.6
Remote Mode
Entering this screen places the T16-ISO Instrument into Remote Connection Mode. If the instrument is connected to a PC loaded with the T16-ISO Desktop Software, then a user can conduct tests remotely. The instrument can be connected to the PC via:
Direct connection via a Mini USB cable OR
Connected via an Ethernet cable to the same Network as the computer.
NOTE 13. Exiting this screen will cancel the remote connection. Selecting the checkbox will ensure that the following instrument bootups will automatically land on this screen. This will enable rapid T16-ISO Remote Mode, Desktop Application set ups.
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8
Administrator Settings PASSWORD ACCESS Enter the Password The administrator password is required to access the Administrator settings. Authorised administrator users will be issued with password. Use the administrator settings screen to change or update instrument configuration, including:
Time and Date
Network
Import and Export Functions
Park Optics
Reset to Factory Default
Factory Settings (Password Access)
8.1
Time & Date
The “Time & Date” settings screen allows an Admin user to configure the real time clock calendar within the instrument. The time and date format is hh:mm AM/PM DD MM YYYY in all screen displays and reports. To change the time and date:
Touch a section of the time and date to highlight it for editing.
Use the “Up” and “Down” arrows to increase or decrease value.
Select the “OK” icon to save changes, or “CANCEL” to return to settings screen.
The Instrument incorporates a battery backed real time clock calendar that will retain the time & date when idle or without power connected. The battery has a service life that exceeds 7 years. It can be replaced if necessary but is not a user service item.
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8.2
Network Setup
The “Network” settings allow a user to configure the Ethernet connection to the Instrument. Functions supported include:
Select between DHCP and Static Network.
Enter IP address.
Enter Subnet Mask
Select the “OK” icon to refresh network settings and save changes, or “CANCEL” to return to the settings screen.
The default is DHCP. To switch to static IP, an IP address and subnet mask must be entered manually. DHCP (Router): The T16-ISO instrument supports the use of a typical network with DHCP enabled. Plug the T16-ISO instrument into a network port on the router, then power the T16-ISO instrument on.
8.3
Import and Export Functions
The Import and Export menu provides the following functions:
Export Test Results to a connected USB key
Export Device Log to a connected USB key
Import Test Types created on the T16-ISO Desktop Application from a connected USB key.
Import Customisation Profile created in the Customisation Desktop Application from a connected USB key.
8.3.1
Export Test Results
The Exporting Test results function allows the archive of test results currently viewable in the “Test Results” section to be exported as a set of .JSON and .CSV test results to a USB Flash Memory Key connected to the T16-ISO Instrument. Exported JSON files can be viewed using the T16-ISO Desktop Application. When test result export is successfully completed, the following warning message is displayed: WARNING 0190: Test results exported successfully. Would you like to clear all test results from the instrument? Selecting “OK” will delete all results from the instrument. Selecting “CANCEL” will retain all results on the instrument.
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8.3.2
Exporting Device Log
The T16-ISO Instrument Log file keeps an event history of all Instrument events. If the user is experiencing issues with the instrument they are able to export the Log file to an attached USB Flash Memory Key, which can be supplied to the manufacturer for issue diagnosis and support purposes. 8.3.3
Importing Test Types
The T16-ISO Instrument is supplied by the manufacturer without any Test types loaded onto the device. An administrator user can create Test Types using the T16-ISO Desktop application. Test Types created can be packaged into a .tar file that can be saved to a USB Flash Memory Key. The Administrator user can then import Test Types onto the T16-ISO Instrument from this screen, if the appropriate file type is found on an attached USB Flash Memory Key. The following Warning message is displayed on screen: WARNING 0090: Test Type file {File name}.tar found on USB key. Do you wish to import? New Test Type will replace existing test types. If the Test Types file was successfully imported the instrument displays a confirmational “Info” message to the user. Once the user navigates to the Test Types selection in the New Test workflow they will be able to view and select the newly loaded Test Types. NOTE 14. Importing a New Test Types .tar profile will replace all test types previously loaded onto the device. NOTE 15. The Workspace test types package must be the in USB flash memory key root directory folder for theT16-ISO instrument to find the test types package file. 8.3.4
Importing Customization Profiles
The T16-ISO Instrument is supplied by the manufacturer with default logos loaded onto the device in the Instrument Start-up Sequence and the Help Screen. An administrator user can create a customization profile containing logos using the T16-ISO Customization application. A Customization Profile created can be packaged into a file that can be saved to a USB Flash Memory Key. The Administrator user can then import the Profile onto the T16-ISO Instrument from this screen, if the appropriate file type is found on an attached USB Flash Memory Key.
8.4
Park Optics Head FOR SERVICE USE ONLY
Once the “Park Optics” screen is entered the Optical head will park and will be available for removal for service or replacement. Once “Cancel” is selected the optical module will return to the home position, ready for further testing.
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8.5
Reset to Factory Default FOR SERVICE USE ONLY
The device can be reset to factory default to remove all user configured settings and preferences and all user inputs on the T16-ISO Instrument including Test Results, User Lists and Test Types. THIS CAN NOT BE UNDONE. Please ensure that any important data such as User Lists and Test Results are exported to a USB Memory Key prior to performing Factory Default Reset. The device requires on screen confirmation: WARNING 0080: Reset device settings to factory default? All current settings and data will be lost.
8.6
Factory Settings PASSWORD ACCESS
Access to the Factory Settings is restricted to manufacture only. A Factory Password is required to access this menu.
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9
Error, Warning and Information Screens This section provides troubleshooting steps for specific error and warning codes and explains information messages. Once the steps listed below are executed, if the error or warning persists, contact:
[email protected]. Alternatively, please contact Axxin directly. Australian Office
USA Office
Europe Office
Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia
4370 La Jolla Village Drive, Suite 400 San Diego 92122 CA, USA
45 King William Street London, EC4R 9AN United Kingdom
P: + 61 3 9329 1167 F: + 61 3 8732 0310A BN: 43 120 905 839
P: + 1 858 736 9160 F: + 1 858 346 9300
P+ + 44 (0) 203 714 5650
www.axxin.com
Warning: The software uses a standard Warning screen. A Warning screen will be displayed where a user has made a selection that is not reversible and a confirmation is required. Error: If the Device receives a request or performs an action outside the normal operating parameters for that user/test/function, an error message will be displayed, explaining what error has occurred and requiring the user to confirm the error has been noted before the Device returns to normal operation. In some cases it may cancel a current test and/or require a Device reboot. Information: An information screen supplies the user with important information. There are no [OK] or [Cancel] input required from the user so once the user has finished reading the message [OK] will exit the screen.
NOTE 16. After unexpected power loss, the instrument shall boot up when power is reconnected. In the event of file corruption due to power loss, self test at power up and the test results shall indicate any issues caused.
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10 Update Software The Instrument update process consists of a single file packaged release that is deployed on a USB Flash Memory Key. This packaged release can be issued by email. It can be simply copied to a USB Flash Memory Key and then used to update one or multiple instruments. The single file package contains the Update Package Script, Axxin Firmware Updater and Axxin Application Software Updater. Caution: Stored test data may be at risk of being deleted during the software update process! It is highly recommended that the test result stored on the T16-ISO instrument is archived to an external formatted, USB Key prior to performing a software update. Caution: DO NOT REMOVE USB KEY DURING SOFTWARE UPDATE. USB Flash memory T16-ISO instrument can be removed from the T16-ISO instrument once the software update is complete. Update Sequence: 1) Prior to software update, export test results and users list stored on the T16-ISO instrument. 2) Attach USB key with the required software to the T16-ISO instrument USB port, located on the right hand side of the rear of the instrument. 3) Turn the T16-ISO instrument off by pressing and holding the power button for 3 seconds or longer. 4) Power up the T16-ISO instrument by holding down the power button. The T16-ISO instrument shall begin the start-up sequence. 5) Touch the screen to confirm the update process when a confirmation requests is displayed onscreen. 6) Follow onscreen prompts to complete update process. 7) Remove the USB Key when prompted that the update is complete. Then turn the T16-ISO instrument off by removing the power cable from the T16-ISO instrument. 8) Wait 10 seconds then reattach power and turn on the T16-ISO instrument using by pressing and holding the power button. The T16-ISO instrument shall power up as normal. Observe the version number displayed during start up to confirm that the software update was applied.
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11 Uninstall Software Warning: Do not put both the Axxin supplied .bin files on the same USB key at the same time. It may be recommended that an Application be un-installed and a new update re-installed. Uninstalling the Instrument application: 1) Copy the uninstaller.bin file onto one of the USB Flash Memory Keys. An example of the file type is: update_ax-utility_XXXX.bin 2) This file will be emailed to you by Axxin. 3) Insert the USB Key into the T16-ISO instrument whilst it is power off. 4) Once the USB Key in inserted, power up the instrument. 5) Observe the instrument LCD screen. 6) After bootup (approx 1 min the instrument screen will request the user to click the screen to commence. 7) Click the screen. The removal process takes approx 1 minute and at the end it will display a completion message. 8) Remove the USB key from the instrument 9) Remove power from the instrument.
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12 Data Export and Archive A user can export the following file types from the T16-ISO instrument to a USB key.
Test Results. JSON
Test Results CSV
Log Files
The test results saved on the T16-ISO instrument are in JSON format and contain all test data. The JSON text file format requires a viewer to display its contents and is not directly readable. The log files are in text format and are provided for system diagnostics. Test Results and Data Archive Recommendation: It is highly recommended that a tests results “Archive” is made to an external USB Key and is stored separate to the T16-ISO instrument as a backup. NOTE 17. JSON files can also be viewed in freely available JSON file viewers online.
12.1 Saved Results The application automatically saves test results to a location in the T16-ISO instrument memory. The test results are .JSON files that can be exported, printed and viewed on a PC with a Desktop application. The test results are automatically assigned a default file name. The Test Result file name can be broken down to: T16-ISO instrument ID
_
YYYY
MM
DD
hh
mm
ss
_
Unique Test ID
File ext
81DB3616
_
2015
03
12
18
43
51
_
e11172fa-3d55-4db9-9d48b5aec9672a55
.json
81DB3616_20150312184351_e11172fa-3d55-4db9-9d48-b5aec9672a55.json A .CSV file spreadsheet of the test result can also be exported.
12.2 Published Data Interface When the T16-ISO is set up and connected to a network, a computer on that same network can download JSON test result files directly from the instrument using a web browser. The data available is identical to the JSON files is exported to USB key using the instruments "Export Test Results" function. JSON test results files can be viewed using the T16-ISO Desktop Application. To access the results, open a web browser and enter the following address in the address bar: Error! Hyperlink reference not valid. Where
is the IP address of the T16-ISO instrument. The IP address of the T16-ISO instrument is available in the About screen, Home > Settings > About this device; and is configurable by the administrator in Network Settings, Home > Settings > Administrator Settings (password protected) > Network.
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In the example below, the instrument’s IP address is “172.16.0.110”, so http://172.16.0.110/cgibin/records.cgi is entered as a web address.
NOTE 18. Data is only viewable and downloadable. Results cannot be deleted from the instrument via the web interface.
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13 T16-ISO instrument Specifications ITEM
DESCRIPTION
Number of test bay slots
Configured for up to 16 tubes.
Multiple assays
Supports multiple assay types and test protocols defined on the T16-ISO Desktop application.
Measurement technology
Fluorescent - 3 Channel: FAMTM, HEXTM, ROXTM
Colour Touch Screen:
3.4” diagonal TFT LCD. Simple workflow management Ease of use; Colour 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:
On board storage can store up to 99 results (configurable) History Records allow search and retrieval. Archive or export via USB/ Ethernet.
Power:
12 V DC from external AC/DC supplied plug pack. 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 Ib
Lifetime:
3 year calibration life 5 year instrument life
Printer Support:
Postscript 3 compatible network printer
Operating Environment:
Indoor Use. 10°C to 30°C. 10% to 70% RH (non-condensing). 0 to 2000m altitude. Pollution degree: 2 Pressure 0.763 bar (2000m) to 1.01 bar (sea level) Minimum light conditions of 100 LUX. Maximum light intensity of 5,000 LUX
Storage Environment:
2°C to 45°C, 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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14 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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15 Accessories Accessories that can be used with the T16-ISO instrument are available separately and include a:
USB key
Barcode scanner, the Datalogic QuickScan Barcode Wand QD2430
15.1 USB key The SanDisk, Cruzer Blade key is an example of a typical USB key proven to work with the T16-ISO instrument.
Formatted for FAT32, min 1GB with only 1 partition.
The USB Key doesn’t perform CD-ROM emulation
The USB Key does not have proprietary software loaded to run it.
There is only one USB Key present during a software update process.
Axxin advises the use of a low profile USB Key such as the Lacie, mosKeyto USB Flash Drive to reduce the risk of T16-ISO instrument damage and/or failure due to pronounced accidental loading on the profile of most USB Keys. The Lacie, mosKeyto, USB Key offers a compact USB peripheral profile that will greatly simplify the use of T16-ISO instrument in a real test environment.
15.2 Network Printer The Instrument will print to a network connected printer with Printer Postscript Level 3 support. The printer itself must accept postscript. Where this is simply specified as being part of the printer driver, it may not operate as drivers are not located on the instrument. Use of a monochrome laser printer is recommended. A range of printers with Postscript Level 3 support have been tested with the instrument. Usually the very cheapest printers in a company’s range do not provide the required postscript processing on the instrument. Often postscript capability is included in printers with network capability, where the printer also has a USB connection.
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15.3 Barcode Scanner Datalogic QuickScan Barcode Wand, QD2430 Axxin Instruments can accept input from a standard USB connected barcode wand, where the barcode wand operates in “keyboard mode”. In “keyboard mode” the wand will supply a character string to the USB that appears in any enabled text box as if it was typed from a keyboard. Both the “contact” type barcode wand and CCD or laser “non-contact” type barcode readers can be used. The instrument is configured to automatically accept barcode reader inputs for User ID, TEST ID and Test ID. Plug the cable into the T16-ISO instrument then connect it to the Axxin instrument via USB. For a complete setup and operating procedure refer the Datalogic QuickScan™ QD2430 user manual. SPECIFICATIONS SUMMARY Light Source
LED
Roll (Tilt) Tolerance
Up to ±360°
Pitch Tolerance
±65°
Skew (Yaw) Tolerance
±60°
Print Contrast Minimum
25% minimum reflectance
Operating Temperature
0° to 50°C (32°F to 122°F)
Storage Temperature
−40° to 70°C (−40°F to 158°F)
Humidity
0% to 95% relative humidity, non condensing
Drop test
Scanner withstands 18 drops from 1.5m (5ft)
Ambient Light Immunity
Up to 86,000 Lux
ESD Level
16 KV
Supply Voltage
4.5-14.0 V (DC) 140mA (typical) 380mA (max) 50mA (typical) Height: 163mm (6.4”) Length: 91mm (3.6”) Width: 41mm (1.6”) ~145g (~5.1oz) without cable
Operating Current Idle/Standby Dimension Weight Types Interface
Code 39, EAN, PDF-417, DataMatrix, QR Code. RS232, Keyboard Wedge, USB Com Std., USB Keyboard, USB OEM
More information is available at: http://www.datalogic.com/eng/products/automatic-datacapture/general-purpose-handhelds/quickscan-qd2400-pd-612.html
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16 Cleaning & Decontamination Warning: The isopropyl alcohol used in this procedure is flammable. Ensure T16-ISO instrument is not powered. Do not use isopropyl alcohol within 3m of open flames or sources of ignition. Avoid contact with skin. Warning: T16-ISO instrument may be contaminated. Avoid contact with skin. Wash hands with hand wash after completing decontamination.
Suggested materials:
Gloves: Disposable laboratory gloves
Wipes: Lint free wipes
Swabs: Foam Tipped Swab Name: Chemtronics, Foamtips™ #140 Product No.: CF4050 Swab Length : 2.87" (7.3 cm) Head Material: 100 ppi Open Cell Foam Head W/L: 0.19" x 0.50" (4.8 x 12.7 mm)
Isopropyl Alcohol: 99% Isopropyl Alcohol in a spray dispenser
Hand wash: Disinfectant hand wash
The T16-ISO instrument can be cleaned using a lint free wipe, damp with Isopropyl Alcohol (IPA). Axxin does not recommend using free liquids to clean the T16-ISO instrument. To clean the T16-ISO Tube wells Axxin advises the use of a Foam tip Swab such as the Chemtronics, Foam Tip Swabs, Product Number CF4050. 1. Inspect: Inspect for damage or visible contamination. 2. Dispose: Dispose of any materials left on the instrument such as test parts.. 3. Wipe surfaces: Wipe all surfaces of the instrument with wipes wetted with isopropyl alcohol. Use sufficient alcohol such that the surfaces are clearly wetted by the cleaning process. Surfaces include the LCD display and touch screen. 4. Dip: Dip the Foam tip Swap into the Isopropyl Alcohol and allow any excess fluid to flow off the swap. 5. Insert: the swab in to T16-ISO Tube well and circle the tube wall. If any lint or dust remains on the swab head once swap is removed after cleaning, dispose of swab 6. Dispose: Dispose of all used materials and gloves. 7. Wash hands: Wash hands with the disinfectant hand wash.
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17 Service & Maintenance 17.1 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
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
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
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
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 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.
Software Version of connected instrument:
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?
Control Panel\All Control Panel Items\System 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? Or where you using a USB Cable to connect? 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?).
Description of Fault:
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.
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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17.2 Service & Repair Procedure Axxin recommends the following customer procedure for assessing instrument for return to service. 1. Refer to T16-ISO User Manual for information on instrument operation, troubleshooting, error codes and self test as an initial step in resolving the issue. 2. If problem is not resolved then Axxin recommends contacting [email protected] for further guidance and complete technical information from document D003453 Form, T16-ISO Support Form to assist identification of the issue. Form is available on Axxin web site at www.axxin.com/support or contact [email protected] 3. If problem is not resolved or instrument fails to operate correctly, fails self test,or hardware is deemed to be faulty then contact [email protected] with a completed Return for Service Form. Refer to Section 4 below for instructions. 4. Axxin will acknowledge the receipt of Return for Service Request within 5 business days. 5. Ship the decontaminated T16-ISO instrument to Axxin Australia with the Return for Service Request marked to: Axxin Attn. Service & Repairs Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia 6. On receipt of Instrument at Axxin:
The Instrument is inspected and assigned a service and repair tracking number.
The Instrument is allocated a service category / charge rate during service and inspection and customer is provided a Quote within 5 business days.
Axxin will also confirm if this is a warranty item or chargeable service.
If Quote is accepted by the customer the repair is initiated within 10 business days from date of approval.
If Quote is not accepted by customer or no response is received to Quote provided within 7 business days the Instrument is returned to customer at customers expense.
Axxin provides a report for all service and repair processes completed. A description of service activity, fault diagnosis, repairs and testing activity are detailed in this report.
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17.3 Return for Service Request The customer must complete and provide the Return for Service form (refer Section 5) with any instrument returned for service. Completed form may be supplied electronically via email or shipped with the instrument. The Return for Service Form, D004056 is available on Axxin web site at www.axxin.com/support or print the form below. Axxin must receive a completed form before any work, inspection or service of the instrument can begin. Instruments should be packed securely in the original packing materials before returning to Axxin. Return for Service Checklist:
Return form completed and provided via email or shipped with the T16-ISO instrument.
Copy of the return form retained if required.
T16-ISO instrument serial number noted on shipping documents.
T16-ISO instrument cleared of risks and free of contamination for servicing. (refer to Section 7 for instructions)
All data on the T16-ISO instrument is copied and retained in archive.
T16-ISO instrument is packed in original packaging for shipping.
NOTE 19. All data will be erased from the T16-ISO instrument during service. NOTE 20. Instruments not cleaned for return to service may be returned or an additional fee incurred. NOTE 21. Warranty is voided if the Axxin Warranty Void label has been removed. An additional fee may be incurred to review this instrument. NOTE 22. Instrument is to be shipped in original packaging or equivalent packaging. Instrument may incur damage if not shipped with appropriate packaging material. Please contact [email protected] if further advice is required on return packaging. NOTE 23. No new accessories are supplied with the repaired Instrument. If Instrument is returned without original cable or original power supply as an example then the Instrument is returned without these. NOTE 24. If Axxin Quote is not accepted then instrument will be returned as supplied and an inspection fee charged.
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17.3.1 Quote for Services This table outlines the service category definition and charge rate. SERVICE CATEGORY
DESCRIPTION
TEST APPLIED
CHARGE CATEGORY
Warranty Repair
12 months from original shipment date from Axxin.
Complete final test
NIL
Inspection Fee
If Axxin Quote for repairs is not accepted this fee is applicable for inspecting and handling of returned instrument.
N/A
Inspection
No fault found
No fault found from inspection and testing.
Complete final test
Minor repair charges
Software or update issue. Service inspection to return to known factory status. Replacement of labels. Correction of minor cosmetic or function items.
Complete final test
Minor repair charges
Replacement of a single plastic housing component: bottom, top or LID. Disassembly of instrument to correct internal or electrical damage. Broken connectors (eg USB, Ethernet, Power) Replacement of a single optical module. (optical module parts cost is additional. See below) Cleaning of heat block tube due to liquid ingress Replacement of touch screen & LCD display
Complete final test
Standard repair charges
Replacement of more than one plastic housing component (bottom, top, LID). Replacement of single PCB Water or moisture entry into heat block and instrument chassis Replacement of more than one optical module (optical module parts cost is additional. See below) Replacement of motor or drive assembly
Complete final test
Major repair charges
Complete final test
Replacement instrument cost
Minor repair
Standard repair
Major Repair
Instrument is considered beyond repair. Replacement
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internal chassis rebuild required two of more PCBs require replacement
Purchase of a new replacement instrument may be offered. This is subject to availability of instruments dependent on time after last production.
D003643v3.2 User Manual, Instrument Stand Alone Mode, 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
T16-ISO Return for Service Form Instrument Serial No.
Instrument Software Version
Contact Name Contact Phone No. Contact Email Return Address for Shipping Company Name Street Address State / Province Country
Zip / Postal Code
Courier Information
Name
Account Number Service Information
All instrument data copied and archived?
YES
NO
Instrument cleaned and decontaminated, safe for service?
YES
NO
Is this a warranty repair?
YES
NO
Did the instrument suffer damage?
YES
NO
Description of fault:
Are you authorized to request this repair and authorize payment for service and shipping charges? NAME
SIGNATURE
YES
DATE (dd month yyyy)
Completed form must be provided to Axxin electronically via email or shipped with the instrument before any work, inspection or service of the instrument can begin.
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18 CE Declaration
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19 RoHS Declaration
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20 WEEE Directive Declaration
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21 Warranty & End User License Agreement The T16-ISO product 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.
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 enquiry or request for repair service, contact Axxin after confirming the model and unique silicon chip serial number of your T16-ISO instrument.
21.1 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 device & software is provided solely for use as an experimental device 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.
21.2 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.
21.3 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:
Warnings
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Use of other indicators or readings. Secondary, independent, testing or measurement.
21.4 General Notice The Axxin instrument is intended as a general-purpose device 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.
21.5 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.
21.6 Intended Use This instrument is suppled for research testing and is not an IVD device 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.
21.7 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. 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 Page 54 of 56
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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.
21.8 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.
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21.9 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 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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