T16 User Manual
Contents
1. EJ DNAble Desktop OER Home Instrument Support DNA Eas 16 150 Instrument P COMI6G if Stop Print Export Disconnect Fetive Q Setting Temperature gt User JSmith Lot ID 123456 Samplet 2 Sample 3 Sampled 4 Samples 5 Samples 6 Samples ample 8 Samples 1 Sample ID s 9 Sampled 10 Samplel 11 Samplell 12 13 Samplel 14 Samplet 15 Samplelb 15 Samplel Instrument Ready oet Temperature 56 0 C gt Start Workflow Figure8 Test is ready to start Close Lid The device lid is required to be closed to initiate the start of a test Once the test workflow has started lid open and close events will be recorded in the csv file for review 6 RESULTS DISPLAY All Tubes Test results will be displayed in either an eight or sixteen tube format depending on the number of tubes to be run Below is an example of a sixteen tube summary shown in the results screen 12 of 21 ENVIRGLOGIX DNAble Reader User Manual Version 1 0 To change the views of the All Tubes graph summary the user can switch between the test and control channels to display Tube Overlay The tube overlay graph displays the data readings for all Tubes tested in one graph The graph can only display results for one chan2. 1500 1000 500 T T 120 180 240 300 360 Tubes graph summary Test 1 Control Tube 1 Tube 2 Tube 3 Tube 4 Tube 5 Tube 6 Tube 7 Tube 8 Tube 8 Tube 10 Tube 11 Tube 12 Tube 13 Tube 14 Tube 15 Tube 16 4420 4490 4540 Show Grid Data NE JSMITH 000 000 1 ABC 01 ABC 09 Figure 11 Figure 10 Tube Overlay graph ABC 02 ABC 03 4 ABC 04 10 ABC 10 11 11 12 12 Channel 1 Results c ABC 05 13 ABC 13 14 ABC 06 14 7 07 15 15 18 gt gt dE dE dE dE dE dE dili dili di dii di di di di T I I I T I I I H 1 N v j j D M j A j Jj j Jj eus ha Nae Wu We Pu Eu Wu Ge Wu Wu 1 2 1 5 6 7 C 10 11 12 13 14 15 1 ENVIR QLOGIX DNAble Reader User Manual Version 1 0 Test Results showing Positive and Negative results ABC 08 ABC 16 13 of 21 Tube to Tube 16 Displays an individual graph for each tube and offers the same graph configurations available in the All Tubes view Mouse Over style hovering on data points displays information about that data point e g time raw figures All Tubes Test 1 Tube Overlay Control Results gt Tube 2 2400 Tube 3 Tube 4 Tube 5 P Tube 6 d Tube 7 D adi Tube 8 Tube 9 1200 Tube 10 258 Tube 11 0 I Tube 12 nt Tube 13 Tube 14 Tube 15 1 20 00 00 120 180 4240 300
3. This symbol is used to indicate potentially hot instrument surfaces USB 2 0 High Speed interface connector Wired Ethernet 10 100 Mb s connector DC Power connector for connection with supplied external AC DC power pack 12V DC 3 0 Amp maximum Critical information relating to procedures or use of the instrument PC Personal Computer PCB Printed Circuit Board USB Universal Serial Bus 2 WARNINGS AND SAFE USE gt gt bbbbbbbbbbb Always operate the instrument on a surface that is level and dry and not in direct sunlight Never move the instrument while there is a test in progress To avoid damaging the instrument never place objects on top of it Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded intentional RF sources as these may interfere with the proper operation Warning Any changes or modifications not explicitly approved by Axxin Pty Ltd could void the user s authority to operate this equipment Warning lf a USB extension cable is used with the instrument the total length should not exceed 3 0 meters Warning Hot Surfaces The heater block in this instrument operates up to 65 C and may cause contact burns or damage to materials in contact with these areas Warning This instrument is designed to operate only with the provided power supply plug pack This module forms part of the system Do not operate the system with
4. 360 420 480 600 4560 Show Grid Data Figure 12 Single Tube graph Comments Fields can be entered and edited on running test completed test and previously saved test Additional Test information can be added to the comments section to help a user distinguish tests SAVE AS The application automatically saves test results to a windows file location The default file location allocated during the application installation process is Local Disk C gt Program Files gt gt Axxin 6 ISO Desktop gt Test Results C Program Files Axxin Axxin T16 ISO Desktop TestResults JSON data The test results are JSON files that can be opened viewed exported and printed within the DNAble Reader Desktop Application The test results are automatically assigned a default file name Instrument ID i YYYY MM DD hh mm sS File extension EXAMPLE CCEECA413 _ 2012 04 27 10 5 0l json e g 413 20120427105101 json The Save As function allows the user to resave a results file under a default name or with a user configured name in a user specified file location CSV Spreadsheet data The test data is automatically saved in csv file format upon completion of a test The csv files are automatically assigned a default file name FILENAME FORMAT Instrument ID i YYYY MM DD hh mm sS File extension EXAMPLE CCEECA413 2 2012 04 27 10 5 0l CSV e g CCEEC413 20120427105101 csv 14 of 21 ENVIRQLOGIX DNAble Reader User
5. EJ DNAble Desktop 51 ICONS New Test c Open Self Test Home Instrument Support a_ un pen Not Connected Figure 4 gt Run Hi Save Save As About 5 2 PAGE Desktop Application opening screen Pause Stop id T Import Export EEk Not Connected X Delete Print The Home tab enables viewing of incoming results from the DNAble Reader It displays these results in both a graphic and numeric format during and once testing is complete It presents various view points for a test result The Run button is disabled if no device is connected Use the Select Test Type selection box to make a test type selection prior to running test Navigation between tabs or Tube menu does not hinder incoming results on a running test User can navigate and return 10 of 21 ENVIRGLOGIX DNAble Reader User Manual Version 1 0 5 3 b TEST SETUP To run a test select a Test Type from the drop down list and click EJ DNAble Desktop Home Instrument Support Open ve f N t Run Prir Export Connected Select Test Type Program 1 X 16 150 Instrument COMI6 Disconnect Figure5 Home gt Run gt Select Test Type Enter the e User Name of the Tester e Lot ID of the kit reagents e Sample ID for the tubes undergoing test aag 5 Petive Q The DNAble Reader will continue to heat up until the device has reached the co
6. 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 20 of 21 ENVIRQLOGIX DNAble Reader User Manual Version 1 0 um DNABLE DNA Detection 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 10 7 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 WARRANT
7. Manual Version 1 0 6 2 i PRINT Print and or Save a pdf report of test results either upon completion of a test run or from the review memory screens The DNAble Reader Application offers two print options e Summary Report A one page summary based on the application results view e Tube Graphs Includes Tube to 16 Results Tube Overlay as configured on screen is J Summary J Tube Graphs Print Phy ew T16 1SO SUMMARY TEST amp TUBE GRAPHS REPORT Test Octal eeeeceoccc 00000000 Comments SUMMARY REPORT T16 ISO SUMMARY TEST amp TUBE GRAPHS REPORT TUBE GRAPHS PAGE 3 5 ENVIR QLOGIX DNAble Reader User Manual Version 1 0 th Erin d Export Figure I3 Print Results window T16 ISO SUMMARY TEST amp TUBE GRAPHS REPORT TUBE GRAPHS PAGE 1 5 T16 ISO SUMMARY TEST amp TUBE GRAPHS REPORT tee TUBE GRAPHS PAGE 4 5 Coc teed T16 ISO SUMMARY TEST amp TUBE GRAPHS REPORT TUBE GRAPHS PAGE 2 5 T16 ISO SUMMARY TEST amp TUBE GRAPHS REPORT TUBE GRAPHS PAGE 5 5 Figure 14 Print Results preview Summary Report and Tube Graphs Graphs The following graphs generated as part of the DNAble Reader Test result are included in the printed report e All individual Tubes e Tube overlay as configured on screen e Tube Overlay Defaults e Temperature 63 WH OPEN Previously saved test data can be opened from a file dir
8. ALL 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 ENVIRGLOGIX DNAble Reader User Manual Version 1 0 21 of 21
9. ENVIROLOGIX Putting Science to the Test User Manual n DNABLE DNAble Reader amp Desktop Application Version 1 0 March 2013 PREFACE 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 or EnviroLogix Inc This document is provided as an operational summary to describe the use of the instrument accessed remotely using the supplied desktop software application 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 EnviroLogix Inc 11 CONVENTIONS SYMBOL NAME AN Warning A Hot Surface e a i USB Connector Ethernet Connector Power Connector 12 NOTE Information 1 2 ABBREVIATIONS ID Identification LCD Liquid Crystal Display LED Light Emitting Diode 2 of 21 ENVIRQLOGIX DNAble Reader User Manual Version 1 0 500 Riverside Industrial Parkway Portland ME 04103 Ph 1 866 408 4597 1 207 797 0300 outside U S DESCRIPTION Indicative of a situation which if not avoided could result in injury to the user and or damage to the instrument
10. IES 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 ivy 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 SH
11. UIDELINES The DNAble Reader Instrument is designed to operate safely under these conditions Y Indoor use protected from water Y Pollution Category 2 v Altitude up to 2000m Y Use with specified and supplied external AC DC Y Temperature 10 C to 30 C power Adapto oniy v Relative humidity 10 to 70 non condensing rains Boeke ier ENSUE POMEL paslssmoHld ge readily accessible Y Mains supply voltage fluctuations not to exceed Y unit on a stable level bench an office or 10 of the nominal voltage laboratory environment lt S Installation Categories Overvoltage categories ll 4 of 21 ENVIRQLOGIX DNAble Reader User Manual Version 1 0 3 2 LAYOUT 35 LCD Color Touch Screen Dynamic Graphics Workflow Management Lid Step by Step User Guide Results Display Easy to Clean EEE TTT Power Button Tube Locations 1 to 16 200 uL format Minimum 0 yL Sample Volume Figurel Front View Communications Il USB connection ll SOM UP naling P A d Power Connector External 12 V DC Multi adaptorfor world use Fluorophore Module System Speaker Replaceable Module Audio Tones 3channels Prompts Figure2 Back View ENVIRDLOGIX DNAble Reader User Manual Version 1 0 5 of 21 NABLIE Rapid On Site 976 DNA Detection INSTRUMENT SPECIFICATIONS Number of Tubes Configured for up to 16 tubes Measurement Technology Fluorescent 3 Chann
12. XIN 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
13. a different power supply module The correct power supply is required to maintain the safety and electromagnetic compatibility of the system Warning Risk of electrical shock Do not operate the instrument or the power supply plug pack if it has been opened damaged or exposed to moisture condensation or rain The external power supply plug pack is sealed with no user serviceable parts Do not operate this module with any damaged or exposed parts Warning Do not open or attempt to repair the instrument or other accessories as there is a risk of damage to the instrument This instrument does not contain serviceable parts and should be returned to the supplier for repair Opening the instrument will also void the warranty Real time clock coin battery included in the equipment will run for the operational life and is not a user replaceable item Warning Only operate the instrument for its intended purpose and in accordance with this user manual and warnings Protection provided by the equipment may be impaired if the equipment is operated in a manner contradictory to the above This instrument including power supply is designed to operate within the manufacturers specifications Do not exceed the manufacturer s specifications when in use Warning Position the unit with clear access to connectors Keep connected cables clear of work areas such that tripping or catching will not pull the unit off its work bench The mains socket outlet intended
14. adapter input 100 240V AC 50 60Hz 1 2 Output DC 12 3 5A Approval UL CE C Tick FCC and PSE 4 types plug to fit Australia type UK type US Europe type and China type 6 of 21 ENVIRQLOGIX DNAble Reader User Manual Version 1 0 Rated input voltage 100 240V AC Rated input frequency 50 60Hz Rated input current 2 Amps Operating Environment 0 C to 40 C 10 to 80 RH non condensing Storage Environment 20 C to 80 C 10 to 90 RH non condensing Output voltage 12 Output current 3 5 Amps The supplied power adapter P002090 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 CE Europe MEET Declared amp CE Mark PSE Japan Je0950 H19 55001 H14 BSMI Taiwan CNS13438 CCC China GB4943 2001 UK Britain MEET EN60950 1 2000 3 5 POWER BUTTON The DNAble instrument incorporates a front mounted power button Once power is connected to the rear of the instrument press the button for one second to power up and start the instrument Once the instrument is running it can be turned off shut down by depressing the power button for 3 seconds or longer 3 6 EXTERNAL CONNECTORS T Power Supply Module USB Flash Memory Key 1 North America Printer 3 74 SF China Remote Client Ethernet 10 100 Figure3 Reader Instrument SIC A A E Australia L Back Vi
15. ble Reader User Manual as well as information about the DNAble Reader Application and an import function to enable users to import Test Profiles 8 1 USER MANUAL The DNAble Reader Instrument system user manual is embedded into the application as a pdf file and can be saved or printed from this screen The pdf viewer also provides a find function to enable quick search of key terms Note Adobe Reader must be installed to view help files Ej DNAble Desktop Home Instrument Support QO amp About Import Connect Not Connected Not Connected Figure 16 Support tab window 8 2 D ABOUT The About function provides Version information DHAble Desktop version 1 5 1 0 Build ID 8398337241 Figure 17 About window This software iz supplied under licence All rights reserved Refer to user manual for instructions warnings and licence terms Copyright amp 2011 amp xxin y axxin carm 8 3 b li IMPORT The import function allows the user to update the DNAble Reader desktop software when new Test Types become available e g new assay developed by EnviroLogix The update file tar file will be provided by EnviroLogix when needed ENVIR LOGIX DNAble Reader User Manual Version 1 0 17 of 21 Look ir O DNAble Test Types v a Program 1 Recent Documents Documents hy Computer gt File name Network Files of type Import Tests A Importing wil
16. ectory and viewed only if there is not a test in process 64 NEW TEST The tab cannot display a previous test when a test is running If a user is currently viewing a test result and wishes to clear the screen and begin a new test simply press the New Test button 7 INSTRUMENT TAB The Instrument tab displays information about a currently connected DNAble Reader device with the aim of aiding in the identification of an attached DNAble Reader Instrument Instrument logs and an export print function are also available Ej DNAble Desktop Home Instrument Support 16 150 Instrument p COMIS Print Self Test Disconnect Connected Instrument System Information Instrument Name T16 ISO Instrument Instrument Unique ID TEASE215 IP Address MAC Address 00 04 amp 3 3F 11 34 Instrument Version Information Instrument Engine Version 151 0 Operating System 2 0 Hardware Version 400 Kernel Version 3 0 4 Trayboard Version 3 316 Opto Modules Opto Module 1 Type Opto Module 1 Version Opto Module 2 Type Opto Module 2 Version Opto Module 3 Type Opto Module 3 Version Figure 15 Connected DNAble Reader Information page 7 1 d PRINT Using the print function the user can generate a one page A4 report on the DNAble Reader Instrument used for testing 16 of 21 ENVIRGLOGIX DNAble Reader User Manual Version 1 0 8 SUPPORT TAB The DNAble Desktop application support tab provides a copy of the DNA
17. el Color Touch Screen 3 5 Simple workflow management Ease of use Color icon driver menus and prompts Communications Cable Ethernet for Data Transfer USB Port for data export barcode reader and printer Mini USB Port for Laptop connection Data storage Up to 99 results configurable Power 12 DC from external AC DC supplied plug pack Battery power optional DC Voltage fluctuation 10 DC Current consumption 12 DC 3 0 Amps Dimensions 380 mm L x 122 mm W x 139 mm H 14 0 L x 4 8 VWV x 5 4 H Weight 1 95 kg 4 1 Ib Lifetime 3 year calibration life 5 year instrument life Printers Network Printer Operating Environment Indoor Use 10 to 30 C 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 0 C to 45 C 20 to 7076 RH non condensing for at least 7 days Pressure 0 763 to 1 01 bar 0 to 2000m altitude Maximum duration month cumulative Cleaning Isopropyl Alcohol IPA on a damp lint free wipe no free liquid 12 POWER SUPPLY ADAPTOR SPECIFICATIONS a The DNAble Reader Instrument is operated using only the specified and supplied AC DC power adaptor to ensure both the EMC and safety compliance 4 of the product The Axxin supplied power adapter 12V 3 5 Amps Part Number P002090 Description Power
18. emote Mode Screen Home gt Settings gt Remote Mode Select the Default Remote Mode Startup 8 of 21 ENVIRQLOGIX DNAble Reader User Manual Version 1 0 4 1 2 CONNECT READER TO COMPUTER USB CABLE Desktop Application on Computer A Follow remote connection setup guide Section 4 1 above connecting instrument to computer via USB Cable B Press the instrument power button for one second to power up and start the instrument Confirm that splash screen is displayed at power up 97 ort m C Ensure Instrument is in Remote Mode w D On desktop software click Connect to I view available units ERES E Click to connect to instru ment Connect to an Instrument with USE Instrument Detected Connect F Click disconnect when session is complete 116 4 1 31 11 34 Locate 169 254 4 30 Connect G Connection successful 16 150 Instrument a 169 754 4 80 Disconnect Active Q 5 DESKTOP SOFTWARE The application aims to provide a means of navigating between available functions It also provides a means of navigating between pages Tabs will remain fixed Navigating between pages shall not reset or change the content e g data received for a currently running test shall update the corresponding results page regardless of whether the user is viewing the page Available Tabs ENVIR LOGIX DNAble Reader User Manual Version 1 0 9 of 21
19. ew External Connectors KEU AT Hiina E Barcode Scanner a D Europe UA South America is 7 a iW REA United Kingdom dA Hong Kong 2 Singapore ENVIR LOGIX DNAble Reader User Manual Version 1 0 7 of 21 3 PC REQUIREMENTS PC system requirements for DNAble Reader Desktop Application Operating System Windows 7 Use Windows Update to make sure you have the latest Service Pack installed for your computer Memory Minimum I GB RAM Processor Minimum Intel Core i3 Processor Peripherals Ethernet Connection USB Port Printer Requirements Network printers over Wi Fi or Ethernet USB printer 4 SETUP AND INSTALLATION 4 1 SETUP GUIDE eg SS DNAble Reader Instrument Unpack the DNAble Reader Unit and set Sy up unit on a stable level bench in a clean office or lab type environment E Power Supply Configure the power supply for your region Connect the 12 power supply to the unit Windows Laptop Refer to PC Requirements section Mini USB PC Cable USB key SanDisk Cruzer Blade brand flash memory key formatted for FAT32 with only partition 4 1 1 INSTRUMENT MODES Stand alone mode allows the instrument to run independently with the use of its touch screen There is no need for a network or computer in this mode Remote Connection mode allows a computer with DNAble Reader Desktop installed to control the instrument and obtain data from it To allow remote connection navigate Instrument GUI R
20. l delete any currently installed Test and Decision Definitions Are vou sure you wish bo continue Import Tests 1 Tests have been successfully imported Please restart the application Far changes to take effect Figure 18 Import test types process 9 MAINTENANCE 9 1 CLEANING The DNAble Reader Instrument can be cleaned using a lint free wipe damp with Isopropyl Alcohol IPA Avoid using free liquids to clean the device To clean the wells of the DNAble Reader we advise the use of a foam tip swab such as Chemtronics Foamtips Product Number CF4050 Dip the foam tip swab into the isopropyl alcohol and allow any excess fluid to flow off the swab Insert the swab into the instrument well and circle the tube wall Dispose of swab if any lint or dust is visible and repeat for remaining wells Use spray bottle with compressed air to clean wells of debris 92 FAQ amp TROUBLESHOOTING Contact EnviroLogix at DNAble envirologix com 18 of 21 ENVIRGLOGIX DNAble Reader User Manual Version 1 0 10 WARRANTY amp END USER LICENSE AGREEMENT The software is warranted against defects in materials and workmanship for a period of one 1 year For specific warranty information contact EnviroLogix If any defects should occur during the warranty period EnviroLogix will replace the defective parts without charge However the following defects are specifically excluded e Defects caused by improper operation or by improper packagi
21. nel Control or Tests at a time Tubes hidden and displayed are configurable ar 2000 2000 a 1000 66 1000 a 0 t 0 9 20 00 120 240 300 480 600 8 30 00 120 240 180 600 Tut Tub 4000 4000 3000 3000 2000 si 2000 1000 pee 1000 b T T 0 T T T T 8 36 00 120 240 0 480 800 8 b 120 240 360 480 800 Tut Tut 10 4000 4000 3000 3000 2000 m 27000 A p 1000 e 1000 roo 0 t t t T 0 t t t t 8 30 00 120 240 300 480 600 9 20 00 120 240 00 180 600 Tube 1 14 4000 4000 3000 3000 2000 2000 pr 1000 E 1000 ee ammm b T T T b 8 00 120 240 0 480 800 8 00 120 240 0 480 800 ae ae pt _ _s o o t t t 00 120 240 60 480 e err T T 6 00 120 240 0 480 11 T T 36 00 120 240 60 480 ee oo T T d 120 240 0 480 Tut 4000 3000 2000 1000 m 00 120 240 0 n 4000 3000 2000 1000 i Rm dc 0 8 30 00 120 240 360 Tube 1 4000 3000 2000 1000 ee b T 8 36 00 120 240 n Figure 9 by the check boxes on the right hand side of the application window Results The results view visually displays the tube results with one of the following possible results Test Fields User Name Lot ID Sample ID s Results Tube Overlay 5000 4 4600 4 1 4000 3500 3000 2500 2000
22. ng of returned goods e Repair or modifications done by anyone other than EnviroLogix e Use with tubes or materials not specified by EnviroLogix e Deliberate or accidental misuse e Damage caused by disaster e Damage due to use of improper solvent or sample The warranty does not apply to fuses For inquiry or request for repair service contact EnviroLogix after confirming the serial number of your instrument 10 1 LIMITATIONS 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 10 2 DESIGN LIFE AND UPDATES This instrument has a design life of five years After this period the equipment must be decommissioned and not used or specifically evaluated for any further application or extension of life and support EnviroLogix Inc reserves the right to issue a change notice relating to the constructi
23. on 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 10 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 EnviroLogix supplied equipment such as e Warnings e Use of other indicators or readings e Secondary independent testing or measurement 10 4 LICENSING AND THIRD PARTY INTELLECTUAL PROPERTY The DNAble Reader 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 ENVIR LOGIX DNAble Reader User Manual Version 1 0 19 of 21 NABLIE Rapid On Site 976 DNA Detection 10 5 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 AX
24. rrect temperature for testing The Start Workflow button located at the bottom of the screen will be disabled until the device is ready DNAble Desktop Home Instrument Support h Print Export OIDIOIOOIDIDIO 16 150 Instrument COG Disconnect Save As New Stop Setting Temperature User Name Lot ID 1 Sample ID s 9 11 12 13 14 Figure Setup Start Workflow screen Instrument Ready Set Temperature 56 0 C gt Start Workflow Sm DNA oe v Bk fetive o ENVIR LOGIX DNAble Reader User Manual Version 1 0 of 21 Sample IDs Entering Sample IDs into DNAble Reader Application is recommended User Name JSmith Lot ID 56789 1 ABCH 2 ABCOZ 3 ABCO3 4 ABCH 5 ABCOS ABCOB ABCOT ABCOS sample ID s 9 10 11 12 13 14 15 16 Figure7 Auto filled Sample ID To enable the rapid entry of Sample IDs if an alpha followed by a numeric Sample ID is entered for example ABCO I then the information can be auto filled The auto fill icon will appear in the Tube 01 Sample ID field only once a numeric has been entered 5 4 RUNNING A TEST Once the sample tubes have been inserted the User Lot and Sample IDs have been entered the DNAble Reader is at temperature and the device lid is closed then the user is ready to start a test
25. t or provide any input to the requirements safety or processing of any diagnostic test See the specific product insert for assay procedure NOTE I It is the manufacturer s responsibility to provide equipment electromagnetic compatibility information to the customer or user NOTE 2 It is the user s responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended NOTE 3 This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 5 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected SAFE USE G
26. to use with the DNAble Readers external power pack should be located near the equipment and should be readily accessible It s recommended that the user unplug the DNAble Reader Instrument when not in use Warning USB and Ethernet Interfaces If intended for connection to external equipment please ensure that interfaces of such equipment are separated from mains by double the reinforced insulation and present no risk of electrical shock ENVIRGLOGIX DNAble Reader User Manual Version 1 0 3 of 21 INTRODUCTION This document describes setup configuration and operation of the DNAble Reader Instrument that works in conjunction with the Desktop software application The DNAble Reader Instrument complies with the emission and immunity requirements described in EC6 1326 2 6 The instrument manufacturer advises the user to assess the electromagnetic environment of the intended operational environment of the device prior to use The instrument test set up is conducted on the DNAble Reader Desktop application and displays detailed test results of a test that can be exported or printed When running a test the desktop application displays live graphs of the tube measurements The application will save and allow measured data including a csv file and graph images to be exported This document is provided as an operational guide to describe the use of the instrument This document does not describe operation of the specific diagnostic tes
27. unfair competition law or other similar protections regardless of whether or not such rights or protections are registered or perfected the Intellectual Property Rights in the computer software and hardware together with any related documentation including design systems and user and other materials for use in connection with such computer software in this package collectively the Licensed Works ALL INTELLECTUAL PROPERTY RIGHTS IN AND TO THE LICENSED WORKS ARE AND SHALL REMAIN IN LICENSOR NO COMMERCIAL USE This License Agreement grants you the right to use the Software for solely for the intended use with Axxin products PRODUCT ACTIVATION Your use of the Software is governed by product activation technology that limits the number of installations and total number of computers on which the Software This product activation technology may not be circumvented or otherwise disabled in any way 10 6 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
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