user manual axxin t8-iso · page 7 of 77 d005566v3.1 user manual, t8 -iso instrument, axxin t8...

User Manual Axxin T8-ISO

T8-Isothermal Instrument

D005566

© 2007 - 2016 Axxin Pty Ltd

All Rights Reserved.

Commercial in Confidence

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of 77 D005566v3.1 User Manual, T8-ISO Instrument, Axxin T8-ISO.docx

Contents

1 Introduction .......................................................................................................................................................................... 6

2 T8-ISO instrument Specifications ......................................................................................................................................... 7

3 General Information ............................................................................................................................................................. 8

3.1 Abbreviations .............................................................................................................................................................. 8

3.2 Conventions ............................................................................................................................................................... 9

3.3 Warnings & Limitations ............................................................................................................................................... 9

3.4 Safety ....................................................................................................................................................................... 11

3.5 Symbols and Labels ................................................................................................................................................. 12

3.6 Contact Information .................................................................................................................................................. 13

4 Instrument Overview .......................................................................................................................................................... 14

4.1 Regulatory Compliance ............................................................................................................................................ 14

4.2 Intended Use ............................................................................................................................................................ 14

4.3 System Components ................................................................................................................................................ 15

4.4 Instrument Overview ................................................................................................................................................. 15

4.5 Front Status Light ..................................................................................................................................................... 16

4.6 Power Button ............................................................................................................................................................ 16

4.7 External Connections................................................................................................................................................ 16

4.8 Lid ............................................................................................................................................................................ 17

4.9 Test Tubes ............................................................................................................................................................... 17

4.10 Instrument Software Menus ...................................................................................................................................... 18

4.11 User Interface ........................................................................................................................................................... 19

5 Start up .............................................................................................................................................................................. 21

5.1 Initial Setup ............................................................................................................................................................... 21

5.2 Power up .................................................................................................................................................................. 22

5.3 Self Test (only shown if error is found) ...................................................................................................................... 22

5.4 User Login ................................................................................................................................................................ 22

5.5 Home Menu .............................................................................................................................................................. 23

6 User Types ........................................................................................................................................................................ 24

6.1 Standard User .......................................................................................................................................................... 24

6.2 Admin User ............................................................................................................................................................... 24

6.3 Factory User ............................................................................................................................................................. 24

6.4 Changing User Types ............................................................................................................................................... 25

7 Run Test ............................................................................................................................................................................ 26

7.1 Tube Results ............................................................................................................................................................ 27

7.2 Save Results ............................................................................................................................................................ 28

8 Test Results ....................................................................................................................................................................... 29

9 Settings.............................................................................................................................................................................. 30

9.1 About Screen ............................................................................................................................................................ 30

9.2 Audio Volume ........................................................................................................................................................... 31

9.3 Brightness ................................................................................................................................................................ 31

9.4 Help .......................................................................................................................................................................... 31

9.5 Legal ........................................................................................................................................................................ 31

10 Admin Settings ................................................................................................................................................................... 32

10.1 User List ................................................................................................................................................................... 32

10.2 User Login ................................................................................................................................................................ 33

10.3 Auto Logout .............................................................................................................................................................. 33

10.4 Change Admin Password ......................................................................................................................................... 34

10.5 Set Clock .................................................................................................................................................................. 34


10.6 Test List .................................................................................................................................................................... 34

10.7 Default Test Settings ................................................................................................................................................ 35

10.8 Print Options ............................................................................................................................................................. 35

10.9 Language ................................................................................................................................................................. 35

10.10 Temperature ............................................................................................................................................................. 35

10.11 Update Software ....................................................................................................................................................... 36

10.12 Restore Defaults ....................................................................................................................................................... 36

10.13 Import Resources ..................................................................................................................................................... 36

10.14 Open Lid ................................................................................................................................................................... 37

10.15 Run Self Test ............................................................................................................................................................ 37

10.16 Export Logfile ........................................................................................................................................................... 37

11 Factory Settings ................................................................................................................................................................. 38

11.1 Reading Test ............................................................................................................................................................ 39

11.2 Function Tests .......................................................................................................................................................... 39

11.3 Motor Tests .............................................................................................................................................................. 40

11.4 Calibration Record .................................................................................................................................................... 40

11.5 Import Result Files .................................................................................................................................................... 40

11.6 Block Temperature Calibration.................................................................................................................................. 40

11.7 FAM/ROX/HEX Normalisation .................................................................................................................................. 41

12 Creating & Loading Test Type Packages ........................................................................................................................... 42

12.1 Importing Test Types from a USB ............................................................................................................................. 42

12.2 Generating a Test Type Barcode .............................................................................................................................. 43

13 Errors, Warnings and Information....................................................................................................................................... 46

14 Software Update ................................................................................................................................................................ 47

14.1 Update Software ....................................................................................................................................................... 47

15 Data Export and Archive .................................................................................................................................................... 50

15.1 Export Result Process .............................................................................................................................................. 50

16 Restoring Factory Defaults ................................................................................................................................................. 52

17 Comparison between T8-ISO and T16-ISO Instrument Specifications................................................................................ 53

18 12V Power Supply Adaptor Specifications ......................................................................................................................... 55

19 Peripherals ........................................................................................................................................................................ 56

19.1 USB Key ................................................................................................................................................................... 56

19.2 Barcode Scanner ...................................................................................................................................................... 56

19.2.1 Barcode Scanner Details .................................................................................................................................... 57

19.2.2 Barcode Scanner Cable ..................................................................................................................................... 58

19.3 Label Printer ............................................................................................................................................................. 59

19.3.1 Printed Report Format ........................................................................................................................................ 60

19.3.2 Label Printer Cable ............................................................................................................................................. 61

20 Cleaning & Decontamination .............................................................................................................................................. 62

21 Service & Maintenance ...................................................................................................................................................... 63

21.1 Software Issue Reporting ......................................................................................................................................... 63

21.2 Service & Repair Procedure ..................................................................................................................................... 66

21.3 Return for Service Request ....................................................................................................................................... 67

21.3.1 Quote for Services .............................................................................................................................................. 68

22 CE Declaration ................................................................................................................................................................... 70

23 RoHS Declaration .............................................................................................................................................................. 71

24 WEEE Directive Declaration............................................................................................................................................... 72

25 Warranty & End User License Agreement .......................................................................................................................... 73

25.1 Limitations ................................................................................................................................................................ 73

25.2 Design Life and Updates .......................................................................................................................................... 73


25.3 Instrument Failure and Errors ................................................................................................................................... 73

25.4 General Notice ......................................................................................................................................................... 74

25.5 Licensing and Third Party Intellectual Property ......................................................................................................... 74

25.6 Intended Use ............................................................................................................................................................ 74

25.7 End-User License Agreement ................................................................................................................................... 74

25.8 Restrictions ............................................................................................................................................................... 75

25.9 Warranties and Disclaimer ........................................................................................................................................ 76

25.10 Copyright .................................................................................................................................................................. 77


1 Introduction

This document describes setup, configuration and operation of the T8-ISO Isothermal Test Instrument.

Axxin’s advanced T8-ISO isothermal instrument operates at constant temperature and enables the

next generation of molecular testing in a compact, low cost, stand alone, high sensitivity instrument

suitable for both laboratory and field-based applications.

The T8-ISO Instrument is a portable research instrument that provides measurement of two

fluorophores. The standard instrument configuration is FAM and ROX fluorophores. A HEX

fluorescence module is also available as a build option.

This instrument is intended for research and development use only and is not intended for in vitro

diagnostic (IVD) medical use without further assay and application specific, verification, testing and

software.

When used in research work the T8-ISO instrument forms part of a larger test system including the

chemistry assay under test and risks for the overall system should be considered.

If the intended research use carries risks of loss or injury, additional tests or indicators must be

considered to mitigate these risks.

It is the user’s responsibility to follow all diagnostic test kit instructions for use with T8-ISO Instrument.

Any improper use leading to test failure such as contamination, lot expiry or incorrect sample handling

is the responsibility of the user and falls outside the scope of Axxin.


2 T8-ISO instrument Specifications

Number of Tubes Configured for 8 tubes Accepts 8 x 200µL PCR tubes (standard 8 tube strip)

Scan Time 10, 15 or 20 seconds

Data Storage 50 test results can be stored on the instrument. History Records allow search and retrieval. Archive or export via USB/ Ethernet.

Multiple Assays, Test Types Supports multiple assay types and test protocols defined on the T8-ISO Desktop Utility. 10 test types can be stored on the instrument, imported from a USB data file or scanned from a QR code.

Measurement technology 2 Fluorescent Channels. FAM and ROX as standard. Optional FAM, HEX, ROX, Custom, or bioluminescence.

Colour Touch Screen 4.3 inch TFT LCD. Simple workflow management Ease of use; Colour icon driver menus and prompts.

Communications Ethernet Network Connection Mini USB Port for PC connection USB Port for Data Export, Software Update and Test Types import

Power 12 V DC from external AC/DC supplied plug pack. DC Voltage fluctuation ±10% DC Current consumption: 12V DC, 3.0 Amps Power supply adaptor is configured for different regions.

Dimensions Width 185mm (7.28") Depth 203mm (8.00") Height 110mm (4.33")

Weight 2.3 kg (5.1 lb)

Lifetime 5 year design life or 10,000 test whichever occurs first

Printer Support Label printer connected via Serial cable

Barcode Reader Barcode reader connected via Serial cable

Operating Environment Indoor Use. 10°C to 30°C, 10% to 80% 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)


3 General Information

3.1 Abbreviations

Ave. Average

Cal Calibration

ID Identification

IVD In Vitro Diagnostics

LCD Liquid Crystal Display

LED Light-Emitting Diode

LIS Laboratory Information System

PC Personal Computer

PCB Printed Circuit Board

Posn. Position

PWM Pulse Width Modulation

RID Run Identification

SID Sample Identification

USB Universal Serial Bus

Var. Variance

Ver Version


3.2 Conventions

Warning: Indicative of a situation which if not avoided could result in injury of the user

and/or damage of the T8-ISO instrument.

NOTE Information: Critical information relating to procedures or use of the T8-ISO

instrument.

3.3 Warnings & Limitations

Warning: Hot Surface. The heater block in the T8-ISO instrument may cause contact

burns or damage to materials in contact with the heater.

Warning: Always operate the T8-ISO on a surface that is level, dry and not exposed to

direct sunlight.

Warning: Do not move the T8-ISO when conducting a test.

Warning: Do not drop the T8-ISO instrument.

Warning: Do not cover or place objects on top of or directly against the T8-ISO

instrument.

Warning: Only use approved listed peripheral accessories with the T8-ISO instrument.

Warning: Do not use this T8-ISO instrument in close proximity to sources of strong

electromagnetic radiation (e.g. unshielded intentional radio frequency 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 warranty and may introduce unintended risks to the operator.

Warning: If a USB extension cable is used with the T8-ISO instrument the total length

should not exceed 3.0 metres.

Warning: Maximum current supplied by all USB peripherals should not exceed 400mA

per USB port.

Warning: This T8-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 T8-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.


Warning: Do not open or attempt to repair the T8-ISO instrument or other accessories

as there is a risk of damage to the T8-ISO instrument. This T8-ISO instrument does not

contain serviceable parts and should be returned to the supplier for repair. Opening the

T8-ISO instrument will void the warranty.

The 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 T8-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 T8-ISO instrument (including power supply) is designed to operate within the

manufacturer’s specifications. Do not exceed the manufacturer’s specifications when in

use.

Warning: Position the T8-ISO instrument with clear access to connectors. Keep

connected cables clear of work areas such that tripping or catching will not pull the T8-

ISO instrument off its workbench. The mains socket outlet intended for use with the T8-

ISO external power pack should be located near the equipment and should be readily

accessible. It’s recommended that the user unplug the T8-ISO instrument when not in

use for extended periods.

Warning: USB, Serial 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.

Warning: In the instance of sudden power loss due to the power cable being removed or

instrument power failure, a test result file will not be retained during an existing test run.

The power loss will void the current test run data. All other tests previously run on the T8

instrument will be retained per normal.

Warning: It is the user’s responsibility to follow all diagnostic test kit instructions for use

with T8-ISO Instrument. Any improper use leading to test failure such as contamination,

lot expiry or incorrect sample handling is the responsibility of the user and falls outside

the scope of Axxin.

Warning: The user is responsible for confirming the instrument Time and Date settings

are correct before proceeding to performing any diagnostic tests. Failure to incorrectly

set the time and date could lead to incorrectly calling a lot expiry or incorrect time and

date stamp on a test result file.

NOTE: Failure to follow these warnings will void the T8-ISO instrument warranty.


3.4 Safety

The T8-ISO instrument is intended to provide safe and reliable operation when used in accordance to

this User Manual. If the T8-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 T8-ISO instrument is designed to operate safely under these conditions:

Indoor use (protected from water).

Altitude up to 2000 m.

Ambient temperature 10ºC to 30ºC.

Relative humidity 10% to 80% 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 T8-ISO instrument on a stable, level bench, in an office or laboratory environment.

The T8-ISO instrument is not intended as a hand-held device; only operate it on a flat and

level surface.

Install the T8-ISO instrument at least 100 mm from all edges.

Install cables so as to prevent risk of tripping or pulling that may cause damage to T8-ISO

instrument or personal injury.

The T8-ISO instrument is a non-serviceable part, opening the T8-ISO instrument will void the

T8-ISO instrument warranty.


3.5 Symbols and Labels

The following definitions are provided for symbols used in this document or on product labels. The

Regulatory Compliance requirements are described in Section 4.1.

Axxin Pty Ltd Logo

MODEL T8-ISO

P003843 Device Model Number and Axxin Part Number.

CE Mark

RoHS: 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.

This device complies with the FCC Rules

Biological hazards (also known as biohazards): Potential contamination

with 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: Axxin Pty Ltd, www.axxin.com, Made in Australia

USB Port: for connection of USB flash memory key or external barcode

scanner.

Network Port: to connect the T8-ISO instrument to a network.

Power Supply: to connect the supplier power supply to the T8-ISO instrument.

DC Power connector, for connection with supplied external AC/DC power pack.

12VDC, 3.0 A maximum

Power Button: Used to power on /off the T8-ISO instrument

Hot Surface: This symbol is used to indicate potentially hot instrument surfaces.

http://en.wikipedia.org/wiki/Biological

http://www.axxin.com/


The following example compliance label is affixed to the back of the T8-ISO instrument.

3.6 Contact Information

AXXIN PTY LTD

Original Equipment Manufacture

Ground Floor,

582 Heidelberg Rd,

Fairfield, 3078

Victoria, Australia

[email protected]

T + 61 3 9329 1167

F + 61 3 8732 0310

ABN 43 120 905 839


4 Instrument Overview

4.1 Regulatory Compliance

The T8-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.

Refer to the CE Declaration, a copy of which has been provided in Section 22.

This equipment has been tested and found compliant with emissions limits required by CISPR11

Class A equipment.

This T8-ISO instrument complies with Part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) this T8-ISO instrument may not cause harmful interference, and (2) this T8-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.

The Axxin T8-ISO device is RoHS compliant. Please refer to RoHS Declaration, a copy of which has been provided in Section 23.

Refer to the WEEE Declaration, a copy of which has been provided in Section 24.

Axxin advises the user to assess the electromagnetic environment of the intended operational

environment of the T8-ISO instrument prior to use.

4.2 Intended Use

This T8-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 T8-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.


4.3 System Components

The following system components are supplied with the T8-ISO instrument:

T8-ISO Instrument

Power Supply and region specific power adapters

Printer Cable

Barcode Scanner Cable

4.4 Instrument Overview


4.5 Front Status Light

The instrument has a fixed intensity white, front panel LED to indicate power status:

Rapid Flash 5 Hz: Instrument is in bootloader mode (shown during Instrument software

updates)

Medium Flash Instrument is heating up to set temperature (approx. 1 flash per second)

Slow Flash Instrument is in sleep mode (approx. 1 flash per 4 seconds)

On Solid Instrument is running and at set temperature

4.6 Power Button

The T8-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. When the

instrument is running it can be turned off (shut down) by pressing and holding the power button for 3

seconds or longer.

4.7 External Connections

Desktop

application

via USB Printer Barcode Scanner Network Power


4.8 Lid

The Lid is magnetically latched during testing to prevent test failure due to user opening.

The Lid is lifted by a cam mechanism at the completion of each test to allow user to access the test

tubes.

4.9 Test Tubes

The T8-ISO Instrument accepts 8 x 200µL PCR tubes (standard 8 tube strip) or single 200µL PCR

tubes. Axxin recommends the following tubes:

Axygen PCR-0208-C, 8 x 200µL PCR tube strip

Axygen PCR-02-C, single 200µL tube with flat cap

A minimum sample volume of 30 µL is recommended. Typical test volumes are in the range of 50 µL

to 100 µL. The tubes should have a good fit in the block and should not require force to insert.

Figure 1 T8-ISO Instrument compatible PCR 8 tube strip


4.10 Instrument Software Menus

User

Sett

ing

s

Ad

min

Sett

ing

s

Facto

ry

Sett

ing

s

Home Screen

Test

Results

Settings

Audio Volume

About

Legal

Help

Brightness

User Login

User List

Set Clock

Set Admin Password

Auto Logout

Default Test Settings

Test List

Print Options

Temperature

Language

Import Resources

Restore Defaults

Update Software

Open Lid

Run Self Test

Export Logfile

Function Test

Reading Test

Calibration Record

Motor Tests

Lid Temp Cal

Block Temp Cal

Normalize ROX

Normalize FAM

Import Result File

Login Screen

Export Test Results

Print Test Results

Refer to section 6 for information on User Types and

instructions on how to switch between users.


4.11 User Interface

Button: Touch the button to perform action.

Editable text: Touch the yellow text box to edit text.

If the text is a single digit, the digit will increase by 1 with each touch.

If the text is a number, the numerical keypad will be displayed:

If the text is a text string, the QWERTY keypad will be displayed:

Text: Text such as reading results or settings is displayed in a white text box.

This text is not editable.

Test: Touch the Test button / icon to run a new test.

Test Results: Touch the Test Result button to navigate to the Test Results menu

and access test result history.

Settings: Touch the Settings button to navigate to the settings menu.

In Standard User: Allows password input for user to change to either Admin or

Factory User

In Admin/Factory User: Allows access to Admin settings menu

Factory Settings: Available to Factory users only, touch the Factory Settings

icon to navigate to the factory settings menu.


OK: Touch the OK icon to confirm an action, input or settings change,

acknowledge information or perform another action as specified by instructions

on screen. The OK icon must be touched to proceed.

Cancel: Touch the Cancel icon to cancel an action, input, settings change, or

perform another action as specified by instructions on screen. The cancellation of

an action may need to be confirmed e.g. when cancelling a running test.

Up / Down: Touch Up or Down icons to navigate through screens, e.g. through a

list or menu which flows over multiple screens.

Return / Next: Touch the Return or Next icon to navigate through screens.

Print: Touch the Print icon to print information on screen. Printer must be

connected to instrument.

Export: Touch the Export icon to export test result or other content as specified

by instructions on screen. An FAT32-formatted USB key must be connected to

instrument.

Import: Touch the Import icon to import test packages or other content as

specified by instructions on screen. An FAT32-formatted USB key must be

connected to instrument.

Error: An error screen is displayed when an action could not be completed, e.g.

a test could not be completed, USB key was not found, or the self test was failed.

Touch the icon to acknowledge the error.

Warning: A warning screen is displayed when confirmation of an action is

required e.g. user cancels a test in progress.

Touch the icon to confirm the action.

Touch the icon to cancel the action.

Information: An information screen is displayed to notify the user of information,

e.g. export was successful.

Touch the icon to acknowledge the information.

Waiting: A waiting screen is displayed when an action is in progress.

Touch the icon to cancel process.


Page 21 of 77 D005566v3.1 User Manual, T8-ISO Instrument, Axxin T8-ISO.docx

5 Start up

5.1 Initial Setup

Unpack T8-ISO instrument

Unpack the T8-ISO instrument and set up on a stable, level bench, in a

clean office or lab type environment.

Power Supply

Configure the power supply for your region.

Connect the 12V power supply to the T8-ISO instrument.

Test Types on USB Key

Use a USB key to import test types onto the T8-ISO instrument.

Power Off/Standby

It is recommended that the T8-ISO instrument is powered down when

not in use.



5.2 Power up

Connect the 12V power supply adaptor to the

T8-ISO instrument.

Press and hold the power button until the

instrument shows the loading screen.

The instrument will perform a self test.

5.3 Self Test (only shown if error is found)

The instrument runs a self test sequence at start

up.

If all tests pass, the instrument will automatically

load to the “User Login” screen (below).

In the event of an error:

If the self test identifies a fault an error screen is

displayed. Click the icon to acknowledge self

test results.

Some errors will allow the user to continue to

use the instrument with limited functionality.

The user will not be able to run tests if doing so

in the presence of the fault puts the test at risk.

However, if possible, the user will be given

access to diagnostics and export tools to enable

servicing.

If the error persists and use of the instrument is

impaired, refer to Section 21 for service

instructions.

5.4 User Login

Enter User Name and password if requested.

(Login requirements are set by the Admin User

in Section 10.2.)

Standard User: A standard user has access to

the home menu, testing, result review and basic

settings.

Admin User: The admin user has access to the

all the same functionality as the standard user

as well as to the "Admin Settings" screens.



Factory User: The factory user has access to

the all the same functionality as the standard

user as well as to the "Admin Settings" screens

and "Factory Settings" screens. Factory Mode is

indicated by a yellow header bar.

Refer to section 10.1 (User List) for details of setting

up, importing or exporting user lists.

5.5 Home Menu

The “Home Menu” is displayed after start up, self test

and user login.

The “Home Menu” screen provides access to the

following functions:

Test

Results History

Settings



6 User Types

6.1 Standard User

The standard user has access to the home menu, testing, results review and basic settings.

The standard user can:

1. Run a test.

2. Review results.

3. Print a single result.

4. Export results to a USB key and delete the results at completion of export.

5. View the T8-ISO instrument "About" information.

6. Adjust the T8-ISO instruments audio settings.

7. Configure the LCD screen brightness level.

8. Review the T8-ISO instrument "Help & Legal" information.

6.2 Admin User

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:

9. Create and import ‘User Lists’ and login settings.

10. Change the time and date.

11. Import test types onto the T8-ISO instrument.

12. Change default Test settings.

13. Change printed report name.

14. Change language settings.

15. Review and set default temperatures.

16. Update the instrument software.

17. Return the T8-ISO instrument to factory default settings.

18. Import resources to change logo and icons.

19. Open the lid of the instrument

20. Run a Self-Test to check instrument functionality

21. Export instrument log file

6.3 Factory User

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.

The factory user can:

22. Perform reading tests on each tube independent of a test type.



23. Run functional and motor tests of the instrument.

24. Review and print calibration records.

25. Import result files from a USB.

26. Set temperature calibration and normalization details.

6.4 Changing User Types

Login to Admin/Factory Users:

Touch on the settings icon on the home screen.

Touch on the icon to enter a password.

Depending on the password, either Admin

mode or Factory mode will be initiated.

Note:

“admin” is the default password for access to

Admin mode.

Logout:

Logout to return to Standard User mode.

Logout by touching on the icon repeatedly,

navigating to the screen displayed on the left.

Touch the icon to confirm logging out.



7 Run Test

Run Test

Select the "Test" icon on the Home Screen.

Touch a Test Type in the list of test types

installed on the instrument.

Alternatively, scan a Test Type barcode.

Touch the icon to cancel.

Refer to section 10.6 for details of setting up, importing

or exporting test lists.

Refer to section 12.2 for details of setting up and using

the barcode scanner.

Edit Test Details, Run ID & Test ID

Enter a test name: touch the yellow “Run ID”

field.

Enter sample IDs: touch the yellow “Sample ID”

fields for Tube 1 to Tube 8.

Auto fill Sample IDs: enter text in the T1 field,

then touch the "Auto 1-8" button.

Touch the icon to continue.


Heating to Test Temperature

Wait for the heater block to reach the pre-set test

type temperature.


Factory users will be presented with a icon,

allowing them to perform diagnostics without the

instrument heating to test temperature.



Insert Samples and Close Lid

Insert sample tubes.

Close the lid.

The instrument will detect that the lid is closed

and automatically proceed to the next screen.


7.1 Tube Results

The following results are possible for each tube:

Negative Result

Positive Result

Invalid Result

Test Running

The Run ID (“RID”) and Sample ID (“SID”)

entered in Section 7 are displayed on this screen.

The time remaining until test completion is shown

at the bottom of the screen.


Detailed results for each tube can be accessed

by touching its results icon ( ).

Touch the icon, or click the result to navigate

to the graph for the selected tube.

Touch the icons to navigate between

screens.

!



Test Results screen

The “Results” screen is displayed when test is

completed.

Touch a Tube icon to view detailed results.

Touch the icon to print test result.

Touch the icon to export test result.

Touch the icon to run a new test.

Touch the icon to cancel and navigate to the

Home Screen.

Test Result Details

Detailed “Results” screens.

Touch the tube result (“Tube 1 NEGATIVE” in the

screenshot) to view the result graph (if enabled in

the test type).


screens displayed on the left.

7.2 Save Results

The application automatically saves test results to a location in the T8-ISO Instrument memory.

Refer to section 15 for details of exporting test results to a USB key.

The test results are .CSV files that can be opened and viewed on a PC and printed.



8 Test Results

Results List Menu

Touch the "Results" icon on the Home Screen.

A list of test results is displayed.

Touch a test result in the list to view result.

Touch Export Results icon to export results

to a USB key.

Refer to section 15 for details of exporting test

results to a USB key.

Results screen

Touch a Tube icon to view detailed results.

Touch the icon to cancel and navigate to the

“Home Screen”.

Touch the icon to print test result (refer to

section 19.3).

Touch the icon to export test result (refer to

section 15).

Result Details

Detailed results screens.

Touch the Forward icon to navigate to the

next screen and the to go back to the

previous screen.



9 Settings

The “Settings” menu is available to all Users.

Touch the Settings icon on the “Home Screen”.

Touch a menu button to navigate to that item.

9.1 About Screen

The “About” screen provides instrument

configuration information, including:

Model

Serial Number

Silicon ID

Hardware Version (Ver.)

Software Version

Bootloader Version

Test Package

Test Count

Scan Cycles

FAM/ROX/HEX Optical Module

Firmware (Compensation or Not)

IP Address

MAC Address


screens.

Touch the icon to print the information (refer

to section 19.3).

Touch the icon to return to the “Settings”

menu.



9.2 Audio Volume

Touch the icons to adjust volume levels.

Touch the “Test” icons to play a test sound.

Touch the icon to save the settings for this

current session.


9.3 Brightness

Touch the icons to adjust LCD screen

brightness.

Touch the icon to save the settings for this

current session.


9.4 Help

Axxin contact information is provided:

www.axxin.com

[email protected]

Copyright information is also displayed.

9.5 Legal

Axxin contact website for accessing licensing

information is provided:

www.axxin.com

License details are also provided in the last

section of this user manual.


mailto:[email protected]




10 Admin Settings

Admin settings are available to Admin and

Factory Users.

Navigate to the Admin Settings by touching the

icon on the “Settings” screen.



screens.

Touch the icon to return the basic settings

menu.

If the user is logged in as Factory User, the

icon will be visible on the “Admin

Settings” screens.

Touch the icon to access “Factory

Settings”.

10.1 User List

Touch the “User List” button to delete users or

edit user names and passwords.

Touch to navigate through the user list

screens.

Touch the Import icon to import a user list

from a USB device.



Touch the Export icon to export the user

list to a USB device.

To make changes, touch a user name. Edit the

user name or password by typing in the yellow

fields.

Touch the “Delete User” button to delete that

user.

Touch to confirm settings or to cancel.

10.2 User Login

Touch “User Login” button to change user login

requirements. Touch button repeatedly to switch

between the following options:

-Password: requires password to login.

-User name: requires user name and password to

login.

-Not req’d: no password or username required.

10.3 Auto Logout

Touch the “Auto Logout” button to scroll through

logout settings. Touch button repeatedly to switch

between the following options:

-Never: the instrument will not auto logout.

-5 mins: Auto logout after 5 minutes idleness.






10.4 Change Admin Password

Enter a new admin password.

Touch to confirm.

Touch to cancel.

Re-enter the new admin password.

Touch to confirm.

Touch to cancel.

10.5 Set Clock

Touch to adjust selected value.

Touch to move to the next field.

Touch the “Display Mode” button to select 24

hour (24 hr) or 12 hour (AM/PM) time format.

Touch to confirm setting.

10.6 Test List

Touch the icons to enable or disable test

types. Enabled test types will be available to all

users in the “Test” menu.

Touch to navigate through the “Test List”

screens.

Touch the Import icon to import the Test

List from a USB device (refer to section 12.1).




10.7 Default Test Settings

To make changes, touch one of the yellow

fields and enter a numeric value in the prompt.


10.8 Print Options

Touch the yellow field to enter a report name.


10.9 Language

Touch the buttons to select language.

The instrument will reboot if the language is

changed.


10.10 Temperature

Reports the temperatures measured in the

Block, Lid and Enclosure.

Set default temperatures for the Block and Lid

by touching on the corresponding yellow fields.




10.11 Update Software

Insert a USB device with the software HEX file.

Touch the “Update Software” button in admin

settings.

Touch to confirm new software update.

The instrument will load the new software and

reboot.

Touch to cancel.

Refer to section 14 for detailed software update

process description.

10.12 Restore Defaults

Touch the “Restore Defaults” button in admin

settings to restore all default settings.

Touch to confirm returning to default

settings.

Touch to cancel.

NOTE: Restoring Defaults deletes all User

Lists, Test Types and Test Results.

Refer to section 16 for list of all items that will

restore to factory settings.

10.13 Import Resources

Allows the user to import customisation files to

change icons and logos.

Insert a USB device with the software HEX file.

Touch to confirm import.



10.14 Open Lid

Touch the “Open Lid” button to force the

instrument to open the lid.

10.15 Run Self Test

Touch the “Run Self-Test” button to run the

instrument self test.

10.16 Export Logfile

Click on “Export Logfile” (with a USB key

inserted) to export the instrument’s log.

The log file tracks the results of every Self-Test

run, instrument details, calibration records and

other pieces of information, and can be

exported out as a csv file.



11 Factory Settings

The Factory Settings are intended for use by the instrument distributor or management group

responsible for managing a set of instruments. The factory screens are accessed by a passcode. This

passcode will be provided to instrument managers separately to this user manual. Contact

[email protected]

CAUTION: Only authorized, trained users should be provided with access to the factory

screens as incorrect setting of options and calibrations can cause measurement error or

incorrect operation of the instrument.

The factory screens are not accessible to a Standard User or Admin User and are intended to

administer specific calibrations, options and functions. Incorrect settings or calibrations entered in the

factory screens can cause measurement error or incorrect operation of the instrument.

Some instrument function can be tested using the Factory Setting screens for the purpose of

diagnostics and repair. These screens also provide the capability to calibrate the instrument.

Factory settings are available to Factory Users

only.

Touch the Factory icon on the “Admin Setting”

screen.




11.1 Reading Test

Touch the yellow “Tube #” box to increment

through tube numbers.

Insert sample in the selected tube location in

the heater block and close the lid.

Touch the button to run a reading test for

the corresponding channel.

Touch or to return to the factory settings

menu.

11.2 Function Tests

Touch the “Function Test” buttons to test the

instrument functions. Blue text indicates the

current status of the part being tested.

LCD Test – Displays colours and B&W shades.

Touch Screen Test – Displays grid with X/Y

coordinates when touched.

LID Cam – Drives lid motor to open and close the

Instrument lid.

Case Fan – Turns on case fan for 10 seconds.

Block Fan – Turns on heater block fan for 10

seconds.

Lid Sensor – Displays lid open/close state.

Debug Button – Displays debug button state.

Home Sensor – Displays home sensor state.

Ethernet Ping – Displays status of Ethernet Ping.

Printer Port – Displays status of Printer Port.

Barcode Port – Displays status of Barcode Port.



11.3 Motor Tests

These options are presented to allow a Factory

User to test specific motor and position

functions.

11.4 Calibration Record

A summary of instrument calibration settings is

displayed.

Touch the icon to print screen.

Touch to return to the “Factory Settings”

menu.

11.5 Import Result Files

Click on “Import Result Files” (with a USB key

inserted) to import previously saved result files.

Files must follow the following naming

convention:

TRxxx.CSV

Where xxx is the test number.

E.g.: TR002.CSV

11.6 Block Temperature Calibration

The block temperature set point setting is

displayed. The current set point can be

adjusted by touching the yellow box.

The current block temperature sensor reading

is displayed.

Adjust the block temperature offsets by

touching the yellow boxes.

Touch to save the calibration.

Touch to cancel details and return to the

“Factory Settings” menu.



11.7 FAM/ROX/HEX Normalisation

Touch the yellow “Tube #” box to increment

through tube numbers.

Touch the yellow “Target box” and enter the

FAM/ROX/HEX target value of the reference

sample used for FAM/ROX/HEX normalization.

Touch the yellow box and enter the LED%

value of the reference sample used for

FAM/ROX/HEX normalization.

Close lid, then touch “Run”.

Normalization will run and a calibration factor is

calculated.

Touch icon to save and apply the

FAM/ROX/HEX calculated normalization factor

setting.

NOTE: Return Normalization to default value.

The “Clear” button can be used to clear the

current normalization and reset its factor to the

default setting of 1.00.



12 Creating & Loading Test Type Packages

When the T8-ISO instrument is first shipped or after it is returned to the User Default state by an

admin user, a single default test will be available for selection by the user for the purposes of

evaluation and demonstration.

A user can create tests specific to their application using the associated Desktop application for the

T8 instrument. These customer specific tests can then be run on the T8-ISO instrument. Two

methods are provided to run user created tests on the instrument. These are:

Up to 10 tests types can be imported from a USB key and saved within the instrument

memory to be run at any time.

A test type can read from a 2 dimensional QR code using an attached barcode reader and

run immediately.

12.1 Importing Test Types from a USB

The user can create Test Types on the Desktop Application and import these onto the instrument

using a USB key.

Create Test Types & Export onto USB

After creating a Test Type on the Desktop Application, export it as a package onto a USB key.

Refer to D005842 User Manual, T8 Desktop Application, Axxin T8-ISO on how to create and export a Test Type Package.

NOTE:

Ensure that only 1 Test Type Package file (*.pkg) is present on the USB key.

Ensure that the Test Type Package is saved at the USB root level (not nested in any folders).

Insert USB into T8-ISO Instrument

Insert USB key with the Test Type Package file (*.pkg) into the T8-ISO instrument’s USB port, located on the front of the instrument.



Import Test Types into T8-ISO Instrument

Log in as an admin/factory user (section 6.4).

Navigate to the Test List screen under admin settings (section 10).

Select the icon to import Test Type Package from the USB key.

Touch to import Test Type Package.

Touch to cancel and return to Test List

screen.

When the Test Type Package has been successfully imported, the Test Types will be available in the Test List screen.

12.2 Generating a Test Type Barcode

Any Test Type created in the Desktop Application can also be exported as a 2D QR barcode (2D) for

use by any T8-ISO instrument.

Refer to document D005842 (User Manual, T8 Desktop Application, Axxin T8-ISO)

for details on how to print QR-Code for test types.

A Test Type barcode can either be scanned from the “Home Screen” or the “New Test” screen.

An example test type printout report is shown on the next page.



Image: Example of Test Type QR-Code Print

A flow chart showing operation of the QR Code test type scanning function within the instrument

workflow is shown on the next page.



Scan QR code

Test error, test expired

Run test type, test workflow continues

Test Type Expired

Test Type Expired

No No

Yes

Yes

No

Yes

Return to HOME / TEST

screen

Test error, test expired

Scan QR code

Return to HOME / TEST

screen

Remain in current screen

(HOME / TEST)

User selects test

Test result

(Expiry date and lot

number are included in

this test result, if

available)

Finish

QR code

valid?

QR Code Type> Test type only

> Expiry date

> Lot #

> Test type

> Expiry date

> Lot #

QR Code Type> Test type only

> Expiry date

> Lot #

> Test type

> Expiry date

> Lot #

Expiry Date and Lot #

is overwritten with latest

values

Start

Expiry Date and Lot #

is overwritten with latest

values



13 Errors, Warnings and Information

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

Ground Floor, 582 Heidelberg Rd, Fairfield, 3078 Victoria, Australia

T + 61 3 9329 1167

F + 61 3 8732 0310

ABN 43 120 905 839

www.axxin.com

USA Office

4370 La Jolla Village Drive, Suite 400 San Diego, CA, 92122 USA

T + 1 858 736 9160

F + 1 858 346 9300

UK Office

45 King William Street London, United Kingdom EC4R 9AN

T + 44 203 714 5650


NOTE: After unexpected power loss, the instrument will 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 will indicate any issues

caused.

Error: An error screen is displayed when an action

could not be completed, e.g. a test could not be

completed, USB key was not found, or self test was

failed.

Touch the icon to acknowledge the error.

Warning: A warning screen is displayed when

confirmation of an action is required e.g. user cancels

a test in progress.

Touch the icon to confirm the action.

Touch the icon to cancel the action.

Information: An information screen is displayed to

notify the user of information, e.g. export was

successful.

Touch the icon to acknowledge the information.





14 Software Update

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.

NOTE: The critical measurement calibrations parameters set in factory settings will not be affected by

a typical software update.

Caution: Stored test data may be at risk of being deleted during the software update

process! It is highly recommended that the test results saved on the T8-ISO instrument are

archived to an external formatted, USB Key prior to performing a software update.

14.1 Update Software

Copy the update file (“T8Update_vXXX.hex”)

onto a USB key.

NOTE: Ensure this is the only .hex file on

the USB, and do not place the file in a

folder.

Turn on the T8-ISO instrument.

Insert USB key with the software update file

into the T8-ISO instrument’s USB port, located

on the front of the instrument.

Touch on the “Settings” button from the home

screen.

Navigate to Admin Settings by touching on the

icon.

When prompted to log in, enter “admin” as the

password.

NOTE: “admin” is the default password and

can be changed.



Touch the “Update Software” button located on

the second page of Admin Settings.

A warning message will display.

Touch to confirm installation of software

update.

An information page will display.

Wait for the transfer to complete.

The instrument will go to a black screen and

the front panel white LED will flash rapidly

during the software update process.

This process may take up to 3 minutes.

DO NOT remove power during the software

update.

When the update has completed, the front

panel white LED will return to a slow flash (idle)

mode.

Press the front panel power switch to start the

instrument.



To confirm the software updated, navigate to

the About screen by touching on the “About”

button in the “Settings” menu.

The current running software version number

will be displayed.

The USB key can be removed.



15 Data Export and Archive

The instrument has an internal test result memory capacity of 50 tests.

Test Results and Data Archive Recommendation: It is highly recommended that test results are

exported to an external USB Key and that this data is stored separately from the T8-ISO instrument

as a backup.

The results from each test on the T8-ISO instrument get saved as

- a test results .csv file, which contains all the test parameters, measured data and final results

- a summary .pdf file, which contains only the final results and corresponds to the printed

results page

The file names are structured in this fashion:

Instrument model - serial number – year – month – day - file number - test name.csv

e.g. T8-S000000-2014-09-07-12-Case 2.csv

A user can export individual test results or all test results on the instrument.

An admin or factory user can delete all tests on the instrument at the completion of a successful

export.

15.1 Export Result Process

Choose Test Result for Export

Touch to navigate through the “Results”

screens.

Touch the Test Name.

Touch the icon to export the selected test

to a USB device.


Insert a FAT32 formatted USB flash memory

key.

Touch the icon to export results.



Export Success

Test results were successfully exported to the

connected USB key.

Touch the icon to acknowledge.

Delete Results

If the user is logged in as Admin User or

Factory User, an additional screen asks if you

wish to delete all test results in the instrument's

test result history.

Touch the icon to confirm removal.

If you want to retain the test results on the

instrument, touch the icon.

Results Deleted

If the icon was selected on the previous

screen, this message will indicate that the

instrument's test result history was successfully

deleted.



16 Restoring Factory Defaults

Refer to section 10.12 for details of how to restore factory defaults.

NOTE: The calibrations parameters set in factory settings will not be affected by restoring default

settings.

The list below shows all parameters that will be updated after restoring default settings:

Parameter Item Default Setting

Settings Touch Volume 60

Alert Volume 80

Brightness 80

Results Test Results None (all deleted)

Admin Settings User List None (all deleted)

User Login None

Auto Logout Timer 0

Admin Password Admin

Test Type Package None (all deleted)

Default Test Edits -

Printed report name -

Network NA

LIS Settings NA

Misc Parameters Heater Set Point Max 70

Start Up Temp Set Point (Lid) 40

Start Up Temp Set Point (Heater Block) 40

Read Cycle Interval 10

Scan Duration 900

Opto PWM Duty FAM 20

Opto PWM Duty ROX 30

Results File Sequence Number 1



17 Comparison between T8-ISO and T16-ISO Instrument

Specifications

T8-ISO T16-ISO Note

Number of tubes 8 16

Number of Fluorescence channels 2 2 or 3 FAM, HEX, ROX, Custom, or

bioluminescence.

Run Standalone, run decision

algorithm and display test results

Display on screen graphs

Run with a connected PC

application Desktop Research

Software

Import Test Types created on

Desktop Software

Import from USB memory key

Normalized Readings T8 and T16 have identical

readings response.

Heated Lid Option

Lid latched during test

Fan assisted, rapid cool down

Block Temperature range 37 to 70 °C 37 to 70 °C

Temperature Accuracy (as shipped) 1 °C 1 °C 0.5 °C with calibration

Temperature resolution 0.1 °C 0.1 °C

10/100 Ethernet Port

Embedded web page

Network Printing Serial attached printer for T8

Label Printer Support

serial

USB

Barcode Reader Support

serial

USB

No of test results stored in history

memory

50 99



T8-ISO T16-ISO Note

Export Test results to USB memory

key

CSV

CSV, JSON

Ambient operation temperature

range

10 to 30 °C 10 to 30 °C

Size (mm) 185 W

203 D

110 H

380 W

125 D

140 H

Weight 2.3 Kg

5.1 lbs

2.0 Kg

4.4 lbs

Power Supply Requirements 12V DC,

3 Amps

12V DC,

3 Amps

Same power supply

Universal External Supply module

included

Adaptors for

AUS, US, Europe, UK

Packaging Cardboard product

box

Moulded

plastic

transit case

Upgrade to Wireless Option

Upgrade to Automated Cloud sync

of results

Option

Laboratory Information System

Interface LIS / LIMS

Option

Internal Self Test Reference Option



18 12V Power Supply Adaptor Specifications

The T8-ISO shall be 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, 3.5A:

Part No: PC003354

Description: Power adapter Input:100-240V 50/60Hz Output:12V

3.5A Approval UL'CE; C-Tick; FCC and PSE 4 types plug can to 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



19 Peripherals

19.1 USB Key

The SanDisk, Cruzer Blade key is an example of a typical USB key proven to

work with the T8-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 require loaded proprietary software to run.

NOTE: There is only one USB Key present during a software update process.

Test Types on USB Key

Use a USB key to import test types onto the T8-ISO instrument.

Blank USB for Archive of Test Results

Use a blank USB key to export test results and instrument data from the T8-ISO instrument.

Software Update on USB Key

Use a USB key loaded with a software update to install the latest software onto the T8-ISO

instrument.

19.2 Barcode Scanner

The T8-ISO instrument accepts a serial connected barcode scanner.

A ‘Test Type’ QR-code can be scanned from either the ‘Home Screen’ or the ‘New Test’ screen to

initiate a new test.

The QR code can include test parameters such as:

1. Test Type – Temperature, test name, decision logic to apply).

2. Expiry Date

3. Lot number



19.2.1 Barcode Scanner Details

Datalogic QuickScan Barcode Wand, QD2430

The T8-ISO Instrument will accept input from a barcode scanner.

The barcode scanner will supply a character string that appears in

the text box as if it was typed on the onscreen keyboard. The

instrument is configured to automatically accept barcode reader

inputs for User ID, Run ID and Test Type.

The recommended barcode scanner is the Datalogic QuickScan™

QD2430. The QD2430 scanner is connected to the instrument via a

specific cable supplied in the pack. (Refer to Section 19.2.2.) It is

also available as a spare part (Part number P004038). Once

connected, the scanner is typically operated in default mode and

will read both standard barcodes and 2D,QR-type barcodes.

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)

Operating Current 140mA (typical) 380mA (max)

Idle/Standby 50mA (typical)

Dimension Height: 163mm (6.4”) Length: 91mm (3.6”) Width: 41mm (1.6”)

Weight ~145g (~5.1oz) without cable

Types Code 39, EAN, PDF-417, DataMatrix, QR Code.

Interface RS232, Keyboard Wedge, SERIAL Com Std., SERIAL Keyboard, SERIAL OEM

More information is available at: http://www.datalogic.com/eng/products/automatic-data-

capture/general-purpose-handhelds/quickscan-qd2400-pd-612.html

http://www.datalogic.com/eng/products/automatic-data-capture/general-purpose-handhelds/quickscan-qd2400-pd-612.html

http://www.datalogic.com/eng/products/automatic-data-capture/general-purpose-handhelds/quickscan-qd2400-pd-612.html



19.2.2 Barcode Scanner Cable

A specific cable is required to connect the scanner to the T8-ISO instrument.

Part number P004038 Cable Assembly, Barcode Scanner.

Refer to section 4.7 for the cable connection location on the rear of the T8-ISO instrument.



19.3 Label Printer

The T8-ISO instrument supports a connected label printer. The recommended printer is the Seiko

SLP 650-SE operating in serial mode. The printer will print the instrument's test report on a receipt or

adhesive shipping label.

The SLP 650-SE label printer is connected to the instrument via a specific cable supplied in the pack.

(Refer to Section 19.3.2.) It is also available as a spare part (Part number P004037).

Serial Label Printer

Seiko SLP 650-SE

Label Part Number: SLP-SRL Label Size: 2-1/8” x 4” ( 53.98 x 101.6mm)



19.3.1 Printed Report Format



19.3.2 Label Printer Cable

A specific cable is required to connect the printer to the T8-ISO instrument.

Part number P004037 Cable Assembly, Printer.

Refer to section 4.7 for the cable connection location on the rear of the T8-ISO instrument.

Printer



20 Cleaning & Decontamination

WARNING: The isopropyl alcohol used in this procedure is flammable.

Ensure T8-ISO instrument is not powered.

Do not use isopropyl alcohol within 3 m of open flames or sources of ignition.

Avoid contact with skin.

WARNING: T8-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 T8-ISO instrument can be cleaned using a lint free wipe dampened with Isopropyl Alcohol (IPA).

Axxin does not recommend using free liquids to clean the T8-ISO instrument.

To clean the T8-ISO Tube wells Axxin advises the use of a Foam tip Swab such as the Chemtronics,

Foam Tip Swabs with 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 into each T8-ISO Tube well and circle the tube wall. If any lint or dust

remains on the swab head once swab 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.



21 Service & Maintenance

21.1 Software Issue Reporting

This user manual contains copies of the following forms that can be used for reporting a software

issue or requesting support:

T16-ISO/T8-ISO Instrument Support Request Form

T16-ISO/T8-ISO Desktop Utility Support Request Form

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

http://www.axxin.com/support.php

Some things to consider when reporting a software defect or bug:

1. Make sure your software is up to date.

2. 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.

3. What where you expecting to see "expected result" and what happened instead "actual

result"?

4. If you are seeing an Error or Warning dialogue, please let us know the Error Code number

"0000" which can be found on the screen.

5. Take note of whether the issue is occurring on the device application or on the desktop

software.

6. Take note of how many instruments are affected.

7. Take note of how frequently you are seeing the defect.

8. Take note of what hardware is connected to the device 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 for each defect, rather than by device.





Thank you for completing this form. Please send your response to [email protected]

T8-ISO INSTRUMENT SUPPORT FORM

Company

Name

Position

Email

T8-ISO INSTRUMENT NOTE

Instrument serial number/s:

Revision Number:

The Instrument Serial Number & Revision Number are

located on a label on the back side of the instrument.

The serial number format is: S00XXXX

and revision number format is R1, R2, R3

Instrument Application Version x.x.x.x: If you are able to access the device application screens,

navigate to: Settings/About/. You will find the entire device

Software, Firmware and Hardware information here.

Description of Fault: Describe the problem in your own words. Which screen

were you looking at when the error occurred? Were any

USB devices such as a USB Memory key or Printer

attached? How frequently are you seeing the issue?

FOR FUTURE REFERENCE:

Please supply the instrument log file as an attachment.

Attach a USB Flash Memory Key to the T8-ISO Instrument.

If you are able to access the device application screens,

navigate to: Setting / Administrator Setting / Enter Admin

Password / Import and Export Functions / Export Logfile

to USB

This exports the device “Logfile” to an attached USB Flash

Memory Key. Please attach the device log file to this email.

Refer to the Instrument User Manual Import and Export

Functions for further information.

mailto:[email protected]?subject=T16-ISO%20Instrument%20Support



Thank you for completing this form. Please send your response to [email protected]

T8-ISO DESKTOP UTILITY SUPPORT FORM

Company

Name

Position

Email

T8-ISO DESKTOP SOFTWARE NOTE

Desktop software version Check the Desktop Software version number, go to:

T8-ISO Desktop Application / Support / About

Software Version of connected instrument

Instrument Application Version x.x.x.x:

If you are able to access the device application screens

navigate to the device information/about screen. You will find

the entire device Software, Firmware and Hardware

information here.

What Windows Operating System are you using?

E.g. Windows 7, 32 bit

To find your system specification go to:

Control Panel\All Control Panel Items\System

Record the Windows edition and the System type

How where you connected to the instrument? Using a network cable and connecting via Ethernet direct

adhoc connection or via Local Area Connection?

Or were you using a USB Cable to connect?

Description of Fault: Describe the problem In your own words. Which screen you

were looking at when the error occurred? At what stage does

the problem occur (e.g. on connection, temperature warm-up,

test run)? How frequent is the problem (e.g. intermittent -

every few tests)? Does the test run ever finish or does it

always crash before this?).

Are you able to take a screen shot of the error?

If so please attach.

If you are looking at the fault on screen, or are seeing an error

message you could take a screen shot of what you see. Hold

down the "Alt" key and press "Print Screen". Either attach or

paste a copy of the image into this email.

FOR FUTURE REFERENCE:

Please perform a self test on the Desktop Software.

Please send us a copy of the Self Test output file, conducted

on the instrument with the issue

Go to T8-ISO Desktop Application/ Instrument/ Self Test,

Run a Self Test and save the test result.CSV file and attach it

to this email. Refer to the Desktop User Manual for further

information. If you cannot access the self test, a log file can be

found at C:\Program Files\Axxin\Axxin T8-ISO

Desktop\Logs

mailto:[email protected]?subject=T16-ISO%20Desktop%20Support



21.2 Service & Repair Procedure

Axxin recommends the following customer procedure for assessing instrument for return to service.

1. Refer to T8-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 completing technical information from document T16-ISO/T8-ISO Support Form

to assist identification of the issue. Form is available on Axxin web site at

http://www.axxin.com/support.php 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 21.3 below for instructions.

4. Axxin will acknowledge the receipt of Return for Service Request within 5 business days.

5. Ship the decontaminated T8-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 whether this is a warranty item or a 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 customer's 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.






21.3 Return for Service Request

The customer must complete and provide the Return for Service form (Refer to 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 is provided 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 T8-ISO instrument.

Copy of the return form retained if required.

T8-ISO instrument serial number noted on shipping documents.

T8-ISO instrument cleared of risks and free of contamination for servicing.

(refer to Section 20 for instructions)

All data on the T8-ISO instrument is copied and retained in an archive.

T8-ISO instrument is packed in original packaging for shipping.

NOTES:

All data will be erased from the T8-ISO instrument during service.

Instruments not cleaned for return to service may be returned or an additional fee incurred.

Warranty is voided if the Axxin Warranty Void label has been removed. An additional fee

may be incurred to review this unit.

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.

No new accessories are supplied with the repaired Instrument. For example, if Instrument is

returned without original cable or original power supply, then the Instrument is returned

without these.

If Axxin Quote is not accepted then instrument will be returned as supplied and an

inspection fee charged.




21.3.1 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

Minor repair

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

Standard repair

Replacement of a single plastic housing component: bottom,

top or LID.

Disassembly of instrument to correct internal or electrical

damage.

Broken connectors (e.g. 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

Major Repair

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

Replacement

Instrument is considered beyond repair if:

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.

Complete

final test

Replacement

instrument cost



T8-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 / Post Code

Courier Name Courier Account No.

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?

YES

NAME SIGNATURE 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.

Axxin Pty Ltd Ground Floor,

582 Heidelberg Rd, Fairfield, 3078

Victoria, Australia



22 CE Declaration



23 RoHS Declaration



24 WEEE Directive Declaration



25 Warranty & End User License Agreement

The T8-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 T8-ISO instrument.

25.1 Limitations

This instrument is intended 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.

25.2 Design Life and Updates

This instrument is intended for desktop research only, and has a design life of five years or 10,000

tests, whichever occurs first. 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.

25.3 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



Use of other indicators or readings.

Secondary, independent, testing or measurement.

25.4 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.

25.5 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.

25.6 Intended Use

This instrument is supplied 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.

25.7 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, non-

exclusive, 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 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 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.

25.8 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.



25.9 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.



25.10 Copyright

© 2007-2016 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 T8-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 other

countries.


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