Quick Start Guide T16-ISO · 5.1 View all Test Results ... If an alpha followed by a numeric Sample ID is entered, for ... The T16-ISO Instrument Test Results screen enables the user

Quick Start Guide T16-ISO

Instrument

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W: www.axxin.com

D004818 Version 1.1

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D004818v1.1 QSG, Quick Start Guide, Axxin T16-ISO Platform 2 of 17

DOCUMENT CONTROL DETAILS

TITLE QSG, Quick Start Guide, Axxin T16-ISO Instrument

DOC No. D004818

CUSTOMER CONTACT General Release

DOCUMENT APPROVAL

POSITION NAME SIGNATURE DATE

Director of Technology Bill Hopper

CEO Andrew Lysikatos

REVISION HISTORY

NO. REVISION DESCRIPTION AUTHOR DATE

1.1 Updated with introduction WRH 29 January 2015

1 First Release CCH 02 December 2013

NOTE: latest revision is first

3 of 17 D004818v1.1 QSG, Quick Start Guide, Axxin T16-ISO Platform

Contents

1 Introduction .......................................................................................................................................................... 4 1.1 Operating Modes....................................................................................................................................... 4 1.2 T16-ISO Instrument Overview ................................................................................................................... 5

2 Setup Guide ......................................................................................................................................................... 6 2.1 Captions and Warnings ............................................................................................................................. 6

3 Start Up.. .............................................................................................................................................................. 7 3.1 Self Test .................................................................................................................................................... 7 3.2 Home Menu .............................................................................................................................................. 7

4 Run Test ................................................................................................................................................................7 5 Test Result History ............................................................................................................................................. 10

5.1 View all Test Results ............................................................................................................................... 10 5.2 Search Filter ............................................................................................................................................ 11 5.3 Go To Test Number ................................................................................................................................ 11

6 Settings.............. ................................................................................................................................................ 12 6.1 About this Device .................................................................................................................................... 12 6.2 Help Information ...................................................................................................................................... 12 6.3 Audio ....................................................................................................................................................... 13 6.4 Brightness ............................................................................................................................................... 13 6.5 Remote Mode ......................................................................................................................................... 13

7 Administrator Settings ........................................................................................................................................ 14 7.1 Time & Date ............................................................................................................................................ 14 7.2 Network Setup ........................................................................................................................................ 14 7.3 Import and Export Functions ................................................................................................................... 15 7.4 Park Optics Head .................................................................................................................................... 15 7.5 Reset to Factory Default ......................................................................................................................... 15 7.6 Factory Settings ...................................................................................................................................... 15

8 Diagnostics ......................................................................................................................................................... 16 9 Instrument Specifications ................................................................................................................................... 17

Commercial in Confidence


1 Introduction This document describes setup, configuration and operation of the T16-ISO Isothermal Test Instrument. Axxin’s advanced T16-ISO instrument provides next generation molecular testing in a compact, stand alone, high sensitivity instrument suitable for both laboratory and field-based applications.

The T16-ISO Instrument is a portable instrument that provides measurement of three fluorophores: FAM, HEX and ROX or other fluorophores with similar spectra.

This instrument is intended for research and development use only and is not intended for in vitro diagnostic (IVD) medical use without further assay and application specific, testing and certification. The T16-ISO instrument forms part of a larger test system including the chemistry assay under test and risks for the overall system should be considered. If the intended use carries risks of loss or injury, additional tests or indicators must be considered to mitigate these risks. This document is a quick guide to assist with instrument setup and use. Refer to the following full user manuals for detailed instructions and warnings: D003643 User Manual, Instrument Stand Alone Mode, Axxin T16-ISO D003374 User Manual, Instrument and Desktop Application, Axxin T16-ISO

1.1 Operating Modes

The T16-ISO instrument will operate in two primary modes, stand alone or connected desktop software mode. When the instrument is connected to a PC, (USB or Ethernet connection) all of the functions of the instrument and tests can be run from the desktop software. Functions available include, run tests, observe tests and curves in real time, customise and calibrate the instrument. The desktop software will also allow the user to develop test types including development of customised decision algorithms. Test types can be run on the attached instrument, or run with previously acquired tests to optimise their functions. Test types can also be exported in a test package and imported on to an instrument.


1.2 T16-ISO Instrument Overview

Figure 1 Front View

Figure 2 Back View

Status LED



2 Setup Guide

2.1 Captions and Warnings

Refer to the T16-ISO standard instrument user manual, D003643 User Manual, Instrument Standalone Mode, Axxin T16-ISO.

Status LED

LED Indication

Green Solid Ready for test

Green Flashing

Heating up or test in progress

Red Flashing

Fault or special mode. Instrument will not run a test.

Setup the T16-ISO instrument on a stable, level bench, in a clean office or lab type environment.

Connect the 12V power supply to the unit.

Connect the power supply to mains power


3 Start Up

3.1 Self Test

Connect power supply to T16-ISO.

Turn on using front panel switch, press for 1 second. The instrument will start up and show a set of software loading screens before progressing to the home menu screen.

3.2 Home Menu

The Home Menu screen provides the following:

Testing History Settings

4 Run Test Select the “Testing” icon on the home screen

Select “Test Type” to view the list of the currently available test types.

The test type that will run next is shown above the ‘Test Type’ button. Select to run this test type.

Select the test type you wish to run from the onscreen test type list.



Enter a Test Name using the onscreen keyboard.

The user enters a Test Name as an additional information field as a reference item to search and identify tests at a later date.

The test screen indicates which tubes need to be inserted for the assigned Test Type. Where a tube is not required, an empty (black) tube location is displayed. In this example all 16 tubes are required for testing.

Tube locations with no Sample ID entries will remain blank until a Sample ID is entered and saved.

Each tube requires a unique Sample ID. Enter a Sample ID by selecting the tube location from the onscreen graphic and using the onscreen keyboard to input the text field. Select “OK” to save text input. Select “Cancel” to navigate back without saving changes.

Sample IDs: If the Test Type requires Sample ID entry this must be done using the Instrument‘s touch screen display prior to testing.

If an alpha followed by a numeric Sample ID is entered, for example ABC00 the information can be auto-filled

Once all Sample IDs have been entered it is now possible to start the test. Insert the samples into the T16-ISO tube s. Select “OK” to proceed. Select “Cancel” to cancel current test.


The T16-ISO Instrument will display the current temperature and the test temperature set in the Test Type. Once the Temperature is set the test can begin.

If the Test Type required the Instrument lid to close during test then the instrument will not initiate testing until the lid is closed by the user.

Once the:

sample tubes have been inserted the test name has been entered all desired Sample IDs have been entered the T16-ISO is at temperature the device lid is closed. The user is ready to start a test.

The “Waiting” workflow item displays the timer countdown in which the sample is held at temperature.

The “Reading” workflow item indicates that fluorescence readings are being taken for the tubes and the channels selected in the Test Type.



5 Test Result History The T16-ISO Instrument Test Results screen enables the user to search through the test data stored. Such information can be searched via a number of different text fields.

5.1 View all Test Results

The following results are possible for the T16-ISO Instrument tests: Negative Result

Positive Result

Invalid Result

Result Not Available

The results screen displays the test results for each of the tubes tested. This information can be printed in a test report by selecting the “Print” icon. To start a new test by selecting the “New Test” icon.

To view more results information about a specific tube result by selecting that tube from the onscreen graphic. In the examples bellow the Tube 6 “Negative” result was selected.

The Detailed Results screen displays the Sample ID and result for that tube.

By selecting the “Graph” icon the user can view a graph for that tube.

Selecting “Print” will print a summary of this screen.

Selecting the graph icon displays the data points recorded over time as the assay develops.

Selecting “Print” will print a summary of this screen.


5.2 Search Filter

Select the “Test Results” icon on the home screen.

Select “Search Filter” to search through all currently available test results to find a specific test.

The following search devices are available:

Search By Test Name

Search By Test Type

Search By Test Number

Search By Sample ID

Use the search filter by selecting one of the above search devices and using the onscreen keyboard to input the text field. Select “OK” to search text input. Select “Cancel” to navigate back without completing search.

5.3 Go To Test Number

Select the “Test Results” icon on the home screen.

Select “Go To Test Number” to search through all currently available test results using a specific test number.



6 Settings The “Settings” screen is accessed from the Home menu and allows a user to configure the instrument.

Use the settings screen to find out information about the T16-ISO device or change/ update device settings, including:

About this device

Help Information

Audio

Brightness

Printer Setup

Remote Mode

Administrator Settings (Password Access)

6.1 About this Device

The “About this device” screen gives information about the T16-ISO Instrument Device including:

Instrument Name Instrument ID Application Version IP Address Mac Address OS build Version Kernel Version

6.2 Help Information The “Help” screen displays the company contact information, T16-ISO Instrument Serial Number and copyright information.

Direct any queries to the company via the website.

Select return to view the first information screen.


6.3 Audio

The instrument sound volume can be edited on this screen. The volume can be adjusted from 0 (no sound) to 5 (highest volume). The test icon allows the user to hear what the current settings are.

The Instrument uses sound for the following functions:

A click whenever the touch screen is used.

Tones to indicate processes such as the end of a test, alerts, and warnings.

Select the “OK” icon to save changes, or “CANCEL” to return to settings screen.

6.4 Brightness

Use the up and down arrows to set instrument LCD brightness.

50% is the default and recommended device setting.

Select the “OK” icon to save changes, or “CANCEL” to return to settings screen.

6.5 Remote Mode

Entering this screen places the T16-ISO Instrument into Remote Connection Mode. If the instrument is connected to a PC loaded with the T16-ISO Desktop Software, then a user can conduct tests remotely.

The instrument can be connected to the PC via:

Direct connection via a Mini USB cable

OR

Connected via an Ethernet cable to the same Network as the computer.



7 Administrator Settings The administrator settings are available under “Settings”

The administrator password is required to access the Administrator settings.

Use the administrator settings screen to change or update instrument configuration, including:

Time and Date

Network

Import and Export Functions

Park Optics

Reset to Factory Default

Factory Settings (Password Access)

The default admin password is “admin”, this can be changed by the user.

If the admin password is lost contact: [email protected]

7.1 Time & Date

The “Time & Date” settings screen allows an Admin user to configure the real time clock calendar within the instrument.

The time and date format is hh:mm AM/PM DD MM YYYY in all screen displays and reports.

7.2 Network Setup

The “Network” settings allow a user to configure the Ethernet connection to the Instrument.

Functions supported include:

Select between DHCP and Static Network.

Enter IP address.

Enter Subnet Mask


7.3 Import and Export Functions

The Import and Export menu provides the following functions:

Export Test Results to a connected USB key

Export Device Log to a connected USB key

Import Test Types created on the T16-ISO Desktop Application from a connected USB key.

Import Customisation Profile created in the Customisation Desktop Application from a connected USB key.

7.4 Park Optics Head

Once the “Park Optics” screen is entered the Optical head will park and will be available for removal for service or replacement.

Once “Cancel” is selected the optical module will return to the home position, ready for further testing.

This is a service function only and is not required in normal use. No user serviceable parts.

7.5 Reset to Factory Default

The device can be reset to factory default to remove all user configured settings and preferences and all user inputs on the T16-ISO Instrument including Test Results, User Lists and Test Types. THIS CAN NOT BE UNDONE. Please ensure that any important data such as User Lists and Test Results are exported to a USB Memory Key prior to performing Factory Default Reset.

The device requires on screen confirmation:

WARNING 0080: Reset device settings to factory default? All current settings, test results and data will be erased.

7.6 Factory Settings

Access to the Factory Settings is restricted to manufacture only. A Factory Password is required to access this menu.



8 Diagnostics A number of functions are available to assist with diagnostics. These are shown in the table below:

Diagnostic Function Description Access

About screen Instrument The instrument about screen provides details of hardware and software version number.

Instrument

<settings>

Software about screen The software about screen provides details of the desktop software version number.

Desktop software

<about>

Instrument log file The instrument log file provides detailed information to assist with diagnostics of instrument issues.

Email to [email protected]

Instrument

<admin settings>

<export>

<log file>

Desktop Software log file The software log file provides detailed information to assist with diagnostics of desktop software issues.

Email to [email protected]

Desktop software

<support tab>

<export>

<log file>

Test result file Export test result from desktop or instrument.

Self test from Desktop Software

Desktop software

<instrument tab>

mailto:[email protected]


9 Instrument Specifications

Number of Tubes Configured for up to 16 tubes

Assays Supports a test types defined on the AX-ISO Desktop application

Measurement Technology Fluorescent - 3 Channel: FAMTM, HEXTM, ROXTM

Colour Touch Screen 3.5”

Simple workflow management Ease of use; Colour icon driver menus and prompts.

Communications Cable Ethernet for Data Transfer. USB Port for data export, barcode reader and printer Mini USB Port for Laptop connection

Data storage Up to 99 results (configurable)

Power 12 V DC from external AC/DC supplied plug pack. Battery power (optional). DC Voltage fluctuation ±10% DC Current consumption: 12V DC, 3.0 Amps

Dimensions 380 mm (L) x 122 mm (W) x 139 mm (H) 14.0” (L) x 4.8” (W) x 5.4” (H)

Weight 1.95 kg 4.1 Ib

Lifetime 3 year calibration life 5 year instrument life

Printers Postscript 3 Network Printer

Operating Environment Indoor Use 10ºC to 30ºC. 10% to 70% RH (non-condensing). 0 to 2000m altitude. Pressure 0.763 bar (2000m) to 1.01 bar (sea level) Pollution category 2 Minimum light conditions of 100 LUX. Maximum light intensity of 5,000 LUX.

Storage Environment 0ºC to 45ºC, 20% to 70% RH (non-condensing) for at least 7 days. Pressure 0.763 to 1.01 bar. 0 to 2000m altitude. Maximum duration 1 month (cumulative)

Cleaning Isopropyl Alcohol (IPA) or 10% bleach solution, on a damp, lint free wipe. (No free liquid)

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Quick Start Guide T16-ISO · 5.1 View all Test Results ... If an alpha followed by a numeric Sample ID is entered, for ... The T16-ISO Instrument Test Results screen enables the user