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User Manual - APPY International

1. 69 10 4 1 SYSTEM INSTALLATION CHECKLIST 70 Venaxis Inc L10019EN Rev 05 Page 4 APPYReader User Manual 1 How To Use This Manual The following conventions are used in this manual Each screen is referenced by the name that appears at the top of the screen Words on the screen titles on screen options and soft key labels are shown in bold Buttons are referenced only by their icon a For example Use and to make the necessary changes To make instructions easy to read soft keys are referenced only by their label For example Press Select to save this setting Sections with blue text contain useful information that is relevant to chapter content or important usage information For example IMPORTANT To maintain the expected useful life of the QC N cassette avoid light exposure Store and reseal the QC cassette in its original pouch immediately after each use 2 Reader Overview The APPYReader Instrument the Reader is a fluorescence instrument used to measure relative fluorescence units RFU generated by lateral flow immunoassay tests manufactured by Venaxis The Reader is designed for use in a laboratory setting Light from the Reader s UV LED hits a Test Cassette once inserted into t
2. 49 5 1 CHECKING THE SOFTWARE VERSION 49 5 2 REVIEWING THE SUPERVISOR 25405554044 vua EXER De A RA RENE e vod drach SE Ra ede qe Sa abt qa v caros uere bun ser en Ee rea a 50 5 3 REVIEWING GLOBAL SETTINGS aseo riri Id ed a S odi a EE n d uS DAT UTE DAL I od Uo a do Dc 52 5 4 DELETING 5 00 st Fata vas nid 62 Suma HR 54 6 MAINTAINING THE 56 6 1 CIFANING THE READER 52506 m T 56 6 2 CHANGING THE PAPER d RER 57 6 3 REPLACING THE BATTERIES aaa Gn 58 7 TROUBLESHOOTING 5 5 52552225545552049 5 ORO PESO ERE 60 7 1 UNDERSTANDING ERROR MESSAGES satus odio Xiao vis ws x ya uua Xd pee ie d Y eae udi ew rele S Pu Vac d d
3. 33 4 3 AOA CONTRO M 34 4 3 1 PING CACC CSS CS RE TER 34 4 3 2 Running Liquid Quality 600000000000000000600 36 44 MANAGING THE QG RESULT 39 4 4 1 Viewing QC Results in Reader 60 enne nnns sease sene ise se na essa essa esses sese a ns 39 4 4 2 Viewing a QC Control Result Stored on a Test Cassette 0 0 60 00000000000000 snas 41 Venaxis Inc L10019EN Rev 05 Page 3 APPYReader User Manual 4 5 TESTINGA PATIENT SAMPLE siesta du VUE x bios E p RM SUE LUE Rt DINE 42 4 6 MANAGING PATIENT RESULTS 1 0 45 4 6 1 Viewing Test Results Reader 0 1 0 nennen nenne se rese 46 4 6 2 Viewing o Result Stored on o Test Cassette exea YER 47 4 7 N 48 5 REVIEW READER
4. 6 2 2 PEADERTRONT A 7 2 3 n 8 2 4 UNDERSTANDING SCREENS AND IVIEN US SIR bed IPFI Ra werent ania Den Med RU p aM MN EU MEE 9 2 4 1 Inici rois io NN 9 2 4 2 COMER ATO c M 10 2 4 3 M OG M 10 2 4 4 VEC LING E 10 2 4 5 ica oET 11 2 5 UNDERSTANDING LABELING 5 12 2 6 Mr 13 2 7 cde igo HQ 13 SETTING UP THE READER IARE NUN CP ESPERE MENT UM 15 3 1 15 3 2 USING AN OPTIONAL BARCODE SCANNER 15 222 TURNING ON THE READER Me 16 3 4 SETTING OR CHANGING THE DATE AND TIME 16 3 5 ADDING THE FIRST SUPERVISOR
5. 5 APPY Reader User Manual APPYReader User Manual Copyright This document discloses subject matter in which Venaxis Inc has certain proprietary rights Neither receipt nor possession of this document confers or transfers any rights to reproduce store in a retrieval system transmit or translate in any form or by any means electronic mechanical photocopying recording or otherwise without prior permission from Venaxis The information contained in this User Manual is subject to change lllustrations including software screen illustrations are representative and may not reflect the most recently released updates Copyright 2014 Venaxis Inc All rights reserved Venaxis Inc Emergo Europe 1585 South Perry Street Molenstraat 15 Castle Rock CO 80104 2513 BH The Hague USA The Netherlands www venaxis com techsupport venaxis com Tel 1 303 794 2000 Fax 1 303 798 8332 For U S Export Only Distributor To locate a distributor in your region please visit Venaxis com Venaxis Inc L10019EN Rev 05 Page 2 APPYReader User Manual Table of Contents 1 2 54485 5 READER OVERVIEW Us VR 5 2 1 CONT TONEN nose
6. Delete Results Screen 4 Use and 7 to highlight the result you want to delete and press Options Ato display the Delete Results Options menu Venaxis Inc L10019EN Rev 05 Page 54 APPYReader User Manual 13 03 14 07 59 Delete Results ID Date Time Result UBKX 13 03 08 09 23AM Inconcl Negative Results List Options Screen Delete Results To delete only the selected result highlight Result and press Select To delete all test results highlight All and press Select To delete all inconclusive test results Inconcl and press Select To delete all negative test results highlight Negative and press Select xx uU S After deleting the Reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted 1 13 12 12 05 29pm Delete Results The selected results have been successfully deleted Delete Results Confirmation Screen 10 Press OK to return to the Delete Results screen or press to return to the supervisor Main Menu screen Venaxis Inc L10019EN Rev 05 Page 55 APPYReader User Manual 6 Maintaining The Reader Standard maintenance activities for the Reader which can be performed by an operator include periodically cleaning the exterior of the Reader changing the paper replacing the batteries Other maintenance activities that might be performed on occasion and can only be performed by a Supervisor include
7. Minute 00 Set Time Screen Venaxis Inc L10019EN Rev 05 Page 17 APPYReader User Manual 8 Use V to toggle between the following screen and printout time format options 12h Select this option to display times in the 12 hour time format with a m and p m 24h Select this option to display times in the 24 hour time format When the preferred time format is displayed press to highlight the Hour field 9 To set the hour and minute use 4 and gt to highlight the respective field Use 4 and Y to change the setting 10 When the correct time is displayed press Confirm to accept all settings 11 If the Reader has been allowed to warm up for 10 minutes you may begin running quality Controls and patient samples See Testing a Patient Sample for instructions 3 5 Adding the First Supervisor User and Additional Users N IMPORTANT You must add the first supervisor user before you can change any Reader settings 1 To create a supervisor when the Create a Supervisor screen is first displayed press OK One Time 12 12 05 05 18 pm Create a Supervisor 2 You will be guided in creating at least one Supervisor Create a Supervisor Confirmation Screen 2 Enter a four digit Operator ID and four digit PIN using the keypad and press Confirm 13 03 07 01 16 nm Enter Operator ID Op 1D PIN Confirm PIN Enter Operator ID Screen 3 Enter Operator Name using Use 4 bd 4 and
8. Set Language English Deutsch Q Frangais Italiano O Nederlands Set Language Screen Venaxis Inc L10019EN Rev 05 Page 10 APPYReader User Manual 2 4 5 Entering Text Text can be entered for Patient IDs supervisor IDs Operator IDs and quality control lot numbers Numbers can be intermixed with letters at any time by using the numeric keypad The text entry screen is automatically shown when entering supervisor and Operator IDs 2 12 12 05 05 07 pm Enter Patient ID Enter a patient ID using the barcode scanner or using the keypad Enter Patient ID Screen Push the Keypad soft key to bring up the text entry screen when entering Patient IDs and quality control lot numbers 13 03 05 04 51 pm Enter Patient ID Bc B E GAS 3 EK OF ST UV 2 Clear all Keypad Screen a Use 4 4 and P to highlight the desired character b Press Confirm to add the highlighted character to the user name c Repeat Step a and Step b as necessary d When the name is complete use 4b Y 4 49 io highlight Done Select Confirm Venaxis Inc L10019EN Rev 05 Page 11 APPYReader User Manual 25 Understanding Labeling Symbols The following symbols are located on the bottom of the Reader i Venaxis Inc L10019EN Rev 05 Consult Instructions for Use For n Vitro Diagnostic Use Catalog Number Humidity Limitation Temperature L
9. changing the date and time updating languages available in the Reader upgrading the Reader software If any other service or maintenance is required the Reader should be sent to the manufacturer See Returning the Reader 6 1 Cleaning the Reader The Reader requires minimal maintenance Occasional cleaning of the exterior is usually sufficient If blood or other fluids are not allowed enough time to fully absorb into test devices the Reader drawer may occasionally require cleaning Use a damp not wet lint free cloth to apply a 70 ethanol solution on the outside of the Reader or to the inside of the Reader drawer Do not allow water to seep into the printer Do not immerse the Reader in water or other liquids If the Reader is moved or returned for replacement or repair the Reader should be cleaned prior to transfer NOTE Never insert any tools swabs or cleaning materials beyond the open Reader drawer Venaxis Inc L10019EN Rev 05 Page 56 APPYReader User Manual 6 2 Changing the Paper You can change the paper in the Reader anytime If the Reader runs out of paper while in the middle of a printing task and displays the Empty Paper Tray message the paper may be changed and the print job restarted To change the paper 1 Remove the printer cover by pulling up on the blue handle on the top of the cover Removing the Printer Cover 2 Remove the empty paper spindle and any unused paper necessary t
10. The result of the QC analysis Cassette Line 0 and Line 1 RFU Values for the QC Cassette APPY value Time The time and date the test was performed LQC Lot The lot number of the cassette used for the test Venaxis Inc L10019EN Rev 05 Page 40 APPYReader User Manual Op ID The ID for the operator that performed the test When you have finished viewing result details press Result List b C d e To print the result highlight Print Result and press Select To print all the test results stored in the Reader highlight Print All and press Select To send the result to a LIS system highlight Send Result and press Select To send all the test results to a LIS system highlight Send and press Select 4 4 2 Viewing QC Control Result Stored on a Test Cassette Perform the following steps to view an individual result stored on a Test Cassette 1 From the operator Main Menu highlight Result History and press Select 12 12 06 03 28 pm T Result History Patient Results Liquid QC Results Qc Cassette Results Read Cassette Result History Screen NOTE The Result History menu item is not available on the supervisor Main Menu screen If you are logged in as a supervisor select Change to Operator 2 Place the Test Cassette over the Reader keypad 3 Use The and V to highlight Read Cassette and press Select Reader displays the Patient ID date time and test
11. 04 pm Settings Maintenance Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout MILI Supervisor Settings Screen Maintenance Screen 3 If you are logged in as a supervisor use and V to highlight Device Info and press Select If you are logged in an operator use and V to highlight Settings and press Select Venaxis Inc L10019EN Rev 05 Page 49 APPYReader User Manual E 01 13 10 06 31 pm Device Info Settings 2 Supervisor History Global Settings Global Settings Supervisor History Device Info Screen Operator Settings Screen 4 Use and v to highlight Software Version and press Select The version information for the Reader s software is displayed 13 03 06 10 17 Software Version Firmware 2 0 3 Bootware 0 0 0 Serial Number 00000000 IP Address 0 0 0 0 Current Software Version Screen 5 Press Back to return to the previous screen or press to return to the Main Menu screen 52 Reviewing the Supervisor History Supervisor users and operator users can review a listing of actions that have been performed by supervisors Perform the following steps to review supervisor history 1 Press to display the Main Menu screen 13 03 07 12 54 pm m 01 05 10 01 05 pm Main Menu Main Menu 2 Settings ey Result History Gh Oper Administration ini Maintenance 12 Change to Operator Supervisor Main Menu
12. ID Already Exists One Time PIN Invalid One Time PIN Invalid Patient ID Invalid Op ID LAN Error Cannot Get IP Address LAN Error Network Cannot Be Configured LIS Error LIS Connection Interrupted Venaxis Inc L10019EN Rev 05 Corrective Action Attempt to read the barcode again If the problem persists check the connection to the barcode scanner As an alternative use the keypad to enter the information manually Replace the Reader s 4 AA batteries or connect the AC power adapter Try again to print Replace the Reader s 4 AA batteries or connect the AC power adapter Replace the paper roll in the Reader Remove the expired Test Cassette and repeat the test with a new Test Cassette The selected Operator ID is already in use Enter a different 4 digit Operator ID Supervisor Login information is incorrect Try again to enter the supervisor information If the problem persists contact Technical Support to obtain a temporary One Time PIN Each PIN is only valid for 24 hours The entered PIN is invalid Try again to enter the one time PIN that was provided If the problem persists contact Technical Support to obtain a new PIN Each PIN is only valid for 24 hours The Patient ID must be 1 to 15 digits Try again to enter the Patient ID The Operator ID must be 4 numbers Try again to enter the Operator ID The DCHP server is not responding with an IP address Contact your network administrat
13. Screen If you select Automatically test results will be printed automatically upon completion of a patient test If you select Manually test results will not be printed automatically upon completion of a patient test Results will have to be printed manually by the user 4 When the desired setting is highlighted press Select to save this setting 5 Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen 3 11 Changing Security and Power Saving Settings Supervisor users can change the following security and power saving settings Logout Time The logout time setting is the duration of inactivity after which a user will be automatically logged out of the Reader Power Off Time The power off time is the duration of inactivity after which the Reader will automatically turn off Auto Login Setting The auto login setting determines whether users are required to enter a login and PIN to use the Reader Perform the following steps to change the logout time power off time or auto login setting 1 Goto the Settings screen 2 Use and Y to highlight Set Login Logout and press Select Venaxis Inc L10019EN Rev 05 Page 28 APPYReader User Manual 13 03 05 08 28 pm Login Logout Timeouts Auto Login Set Login Logout Screen 3 Perform the following steps to change the logout time and or power off time a Use and Y to highlight Set Ti
14. Screen Operator Main Menu Screen 2 lf you are logged in as a supervisor use and v to highlight Settings and press Select If you are logged in as an operator use and v to highlight Maintenance and press Select Venaxis Inc L10019EN Rev 05 Page 50 APPYReader User Manual 01 07 10 03 26 pm 13 03 07 02 04 pm Settings Maintenance Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout KILLING Supervisor Settings Screen Operator Maintenance Screen 3 If you are logged in as a supervisor use and v to highlight Device Info and press Select If you are logged in as an operator use and v to highlight Settings and press Select E 01 13 10 06 31 pm Device Info T Supervisor History Global Settings Global Settings Supervisor History Supervisor Device Info Screen Operator Settings Screen 4 Use and v to highlight Supervisor History and press Select The Reader displays the user ID date time and action identifier for actions that have been performed by supervisor users You can scroll through actions using and v m 01 15 10 00 22 am Supervisor History ID 9 Time lt lt Action Time Action 0011 06 04 08 09 22AM 10 ERU MI 0010 06 03 08 09 21AM 0009 06 02 08 09 20 08 0008 06 01 08 09 19 07 Supervisor History Screen 5 f you want to print the supervisor history press Print 6 Pres
15. To turn off the Reader push the on off switch until the screen menu disappears then release it Venaxis Inc L10019EN Rev 05 Page 48 APPYReader User Manual 5 Review Reader Information NOTE Supervisors and operators can review information about the Reader Some information is only available to supervisor users users can review the version information for the Reader s software See Checking the Software Version for instructions All users can review a summary of the Reader s settings including login logout settings Patient ID settings and the Reader s serial number See Reviewing Global Settings for instructions users can review a listing of actions that have been performed by supervisors See Reviewing the Supervisor History for instructions 51 Checking the Software Version Supervisor users and operator users can review the version information for the Reader s software Perform the following steps to check the software version 1 Press to display the Main Menu screen A 13 03 07 12 54 pm 01 05 10 01 05 pm Main Menu Main Menu a Settings ey Result History Gh Oper Administration in Maintenance 12 Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 2 If you are logged in as a supervisor use and Y to highlight Settings and press Select If you are logged in as an operator use and Y to highlight Maintenance and press Select 01 07 10 03 26 pm 13 03 07 02
16. User Manual 3 Enter your 4 digit PIN 4 Press Login to log in as an operator NOTE You can also press Supervisor Login to log in as a supervisor If you log in as a supervisor you will need to select Change to Operator to test patient samples 4 3 Quality Control Quality control QC testing ensures that the Reader is operating within acceptable ranges QC routines are mandatory and patient tests should not be performed unless required QC is complete Refer to the APPY1 Control Kit Instructions for Use for additional information The Reader performs initialization and self checks each time it is powered on These checks ensure that Communication between the different Reader modules is working Reader settings and calibration integrity are verified optics are functioning properly carriage is free to move correctly carriage position is zeroed IMPORTANT On each day of testing the Reader should be powered on and allowed to complete its initialization and self checks From the Check APPYReader screen you can run the QC cassette QCC provided with the Reader You can also run liquid QC LQC The test result can be printed or sent to the LIS IMPORTANT Follow laboratory procedures regarding how frequently to perform QC checks and how to document the results NOTE To send QC results to the LIS the Reader must be connected to the LIS and the LIS must have been set up by a supe
17. cR 61 B SYSTEM SPECIFICATIONS ERR Rd UDUP RU DUE quA EOS 63 8 1 RETURNING THE 63 8 2 DISPOSING OF THE READER dca dag civic sale ansaid Sd P da RD An NU Eua AUT 63 8 3 ACCESSORIES PART NUMBERS 64 9 GLOSSARY 65 10 BAPPENDICES 66 10 1 8 Ma Ea SS MR Pro dis archa bu IC Met VR ES ear Eni 66 10 2 THEAPPYI SYSTEM CONTROL 68 10 3 THEAPPY1 PATIENT TEST 0
18. gt and press Confirm When preferred Operator Name is done highlight Done and press Confirm Venaxis Inc L10019EN Rev 05 Page 18 APPYReader User Manual 13 03 05 09 24 pm Operator Name Operator Name ABCDEFGHIJKLMN QE RAS UE W SOY Ze Clear all Cont Enter Operator Name Screen NOTE To delete the last character entered press GO 4 Use Y to highlight desired Barcode The following options are available on the Barcode screen 13 03 07 01 18 pm Barcode Assign O Skip To enter a new Barcode choose Assign Use the barcode reader to read the barcode Barcode Screen a To assign a barcode for this user use 4 ang Y to highlight Assign then use the external barcode scanner to scan the barcode The Reader assigns the barcode and displays the RFID screen NOTE To delete this user s barcode return to the Barcode screen and use A and to highlight Reset Then press Confirm b If you do not want to assign a barcode use 4 ang Y to highlight Skip and press Confirm 5 The Reader can be programmed to read the facility supplied RFID card The following options are available a To assign an RFID for this user use ang V to highlight Assign Hold the user s RFID card over the Reader keypad then press Confirm The Reader assigns the RFID and displays the Operator Administration screen Venaxis Inc L10019EN Rev 05 Page 19 APPYReader User Manu
19. in the Reader s memory starting with the most recent test Scroll through results using and 13 03 19 09 37 Result List ID Date Time Result 123123 13 03 13 01 20PM NEGATI XEWT 13 03 08 09 43AM NEGATIV BZQXx 13 03 08 09 33AM Notestr UBKX 13 03 08 09 23AM NEGATIV Result List Screen 3 Use and Y highlight the desired result and press Options A to display the Result List Options screen Venaxis Inc L10019EN Rev 05 Page 46 APPYReader User Manual a m i 13 03 19 09 38 am Result List Options ID Date Time Result 123123 13 03 13 01 20PM Show Details Print All Result List Options Screen Send All To see the result details highlight Show Details and press Select 13 03 18 06 15 pm Result Details Assay APPY1 Result NEGATIVE WBC Entered 12 4 Time 06 15PM 13 03 18 Result List Detailed Result Screen The following information is available on the Detailed Result screen Patient ID The complete Patient ID recorded for the test Assay The assay type that was performed Result The result of the APPY1 Test WBC Entered The entered WBC count Time The time and date the test was performed Lot The lot number of the cassette used for the test Op ID The ID for the operator that performed the test Last LQC The date of the last liquid QC performed on the Reader When you have finished viewing result det
20. result for the result stored on the Test Cassette 4 Use 5 You 13 03 18 06 16 Cassette Details Patient ID 123123 Assay APPY1 Result NEGATIVE WBC Entered 12 4 Time 06 15PM 13 03 18 Read Result on Cassette Screen a and v to review the result stored on the cassette can also press Print to print the result Venaxis Inc L10019EN Rev 05 Page 41 APPYReader User Manual 4 5 Testing a Patient Sample IMPORTANT Allow the Reader to warm up for at least 10 minutes before running any patient samples Perform the following steps to test a patient sample 1 From the operator Main Menu Use and V to highlight Run Test and press Select 12 12 06 02 23 pm D Enter Patient ID Enter a patient ID using the barcode scanner or using the keypad Enter Patient ID Screen 2 Enter the Patient ID using one of the following methods a To enter manually press Keypad b To use a barcode scanner scan the Patient ID 3 Press Confirm 13 03 07 01 43 pm gt Enter WBC Results wec 8 1551 Push Skip if WBC is not available WBC can be entered later Enter WBC Result Screen 4 the patient WBC result is available enter it and press Confirm Otherwise press Skip If you press Skip you will be asked to enter the patient WBC after the test Venaxis Inc L10019EN Rev 05 Page 42 APPYReader User Manual 12 12 06 02 31 Insert Cassette Place a test cassette in the
21. EMENT This instrument complies with Part 15 of the FCC rules Operations are subject to the following two conditions 1 this instrument may not cause harmful interference and 2 this instrument must accept any interference received including interference that may cause undesired operation This instrument has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This instrument generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this instrument does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and the receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult Venaxis an experienced radio TV technician for help CAUTION Any changes or modifications not expressly approved by the grantee of this device
22. Reader warmed up 10 minutes 2 point sample extraction technique 2 points of contact without touching buffy coat WBC Enter within 90 minutes of initiating test _Pipetting Avoid buffy coat 60 second total sample processing Pipette correct volume and no excessive bubbles Cleaning Occasional Cleaning damp non wet lint free cloth exterior and drawer no internal cleaning Troubleshooting and Reader Messages Paperjam Reader Locked up Reset 000000000002 Reader drawerjam Internal QC Out of Range error Measurement failure 220000000 Monitoring Recording and Reporting of Result Retrieve sample and reprint or resend to LIS a User Operator Signature Date Supervisor Signature Date Venaxis Inc provides this sample Training Checklist for the convenience and use of its customers It is the laboratory s responsibility to establish the competency of all users of the APPYReader Instrument at their facility in accordance with the laboratory policies and procedures at the facility This Checklist does not cover all scenarios Information is subject to change Contact Venaxis 1 303 794 2000 or techsupport venaxis com or your authorized APPY1 System distributor for additional assistance Venaxis Inc L10019EN Rev 05 Page 67 APPYReader User Manual 10 2 The APPY1 System Control Log Test Name The APPY1 Test Codes APPYReader
23. Serial OPID Operator ID QCC QC cassette Number C1 Control 1 C2 Control 2 Lab Director Manager acc Control 1 Control 2 Date Control Control ome nr De ore E C1 Ll C2 Ll C2 Ll Venaxis Inc L10019EN Rev 05 Page 68 APPYReader User Manual 10 3 The APPY1 Patient Test Log APP YReader Serial Number Sample Sample Draw Patient ID Lot Centrifuge Time Time Expiration Operator WBC Result Test Result e Date Initials Sample must be centrifuge within 1 hour of sample collection Venaxis Inc L10019EN Rev 05 Page 69 APPYReader User Manual 10 4 The APPY1 System Installation Checklist Hospital Name Installation Date City State Installation Contact Reader Set up Activity Task Initial amp Date EENNITTI OU O o EENNETC CT IN n SetUp Usor Dand opieral RED Caa n 00 seta mapas _ no setSeeumtyana Power sonnas OOOO Set Up Network Connection LIS O Yes O No Determine Type of Connection if any Contact for Integration or Interface Expected Timeframe to Implement Interface Venaxis Inc L10019EN Rev 05 70 APPYReader User Manual FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STAT
24. USER AND ADDITIONAL USERS 1 2 10 1 eene essere seen 18 3 6 CHANGIN SE NIC OM c 24 3 7 clc 24 3 8 E EE MnI Sa Candid pM en MEE SDN ISI aD PRU DNE 25 3 9 CHANGING DATA ENTRY IVIELHODOEEINOSoesusepun Dura Eden r r ENE 26 CHANGING THE PRINT SETTING siirron erorien ninni r EE EErEE EEPE dor 27 3 11 CHANGING SECURITY AND POWER SAVING SETTINGS cesis ice teaser oro RUP TU MIR EG PV EHE REED 28 ST P CONN CUNG TOTEL 5 05 cc 30 3 12 1 Setting Up the Network Connection cies seed een Re a n9 ual agree gu Ree EN Ue pad da enA e EN VA PU PX E 30 S02 2 Seti B Soda E nsec dated urinae editas eden EE AU Oro E eM pM E 32 DAIEY OPERATIONS KS ERU UN MIU MON ss 0d vd NERA DUDARIRAUR 33 4 1 P T 33 4 2 Rr
25. a valid SD card is properly inserted in the Reader No software upgrade was found on the SD card Make sure a valid SD card with a software upgrade is properly inserted in the Reader The confirmed PIN must match the entered PIN The printer temperature is too high for printing Allow the printer to cool off and try again to print There was an error during RFID communication Try again If the problem persists move the Reader away from possible sources of RF interference The SD card may be wrong type or may be damaged Make sure a valid SD card is properly inserted in the Reader The SD card may be wrong type or may be damaged Make sure a valid SD card is properly inserted in the Reader The ambient temperature is outside the measurement range of the Reader 15 C to 30 C Adjust the ambient temperature or relocate the Reader to an area within the operating range Error mitigation prevented generation of APPY1 Test result Repeat with another Test Cassette The user database is full To import more users using the SD card you must first delete existing users Remove the Test Cassette and repeat the test with a new Test Cassette Page 62 APPYReader User Manual 8 System Specifications Product Information APPYReader Part Number F10009 Dimensions 24cm deep x 17cm wide x 12cm high Weight 3 Ibs 1 3Kg Power Requirements AC Operation 6 VDC at 4 16 A Battery Operation 4 AA LR6 Cells Nominal Voltage g
26. ader s auto login feature is enabled Quality control must be performed as required by laboratory procedures 41 Turning On the Reader The on off switch is located on the back of the Reader To turn on the Reader push the on off switch until the Initializing screen appears then release it The Reader displays a splash screen during startup then displays one of the following screens The Login screen is displayed if the Reader s auto login feature is disabled Enter Patient ID screen is displayed if the Reader s auto login feature is enabled IMPORTANT Allow the Reader to warm up for at least 10 minutes before running any patient samples 42 Logging In If necessary perform the following steps to log in to the Reader 1 On the Login screen enter your 4 digit user ID or barcode using one of the following methods Use the numeric keypad to enter your user ID manually Use the optional external barcode scanner to scan your barcode Place your facility supplied RFID card over the Reader keypad Go to Step 4 NOTE Press the back space key lt to delete the last character entered 13 03 05 04 05 pm Login Place your ID card above the keypad or enter ID using the keypad or via barcode then press Operator or Supervisor Op ID acm Barcode PIN Operator Supervisor Login Screen 2 Press 7 to highlight the PIN field Venaxis Inc L10019EN Rev 05 Page 33 APPYReader
27. age 38 APPYReader User Manual 12 Press 2 to eject the drawer Remove the Test Cassette and dispose or store as appropriate 44 Managing the QC Results The Result List screen displays basic information for each patient test result stored in the Reader s memory From the Result List screen you can view details for a QC result send QC results to the LIS print test results You can also view send and print an individual result stored on a Test Cassette NOTE To send a QC result to the LIS the Reader must be connected to the LIS and the LIS must have been set up by a supervisor See Connecting to the LIS for instructions IMPORTANT The Reader can store up to 500 QC amp patient test results When the Reader s memory is full a warning message is N displayed prompting user action If no action is taken results are overwritten as new tests are completed starting with the oldest result in memory 4 4 1 Viewing QC Results in Reader Memory Perform the following steps to view detailed information for test results stored in the Reader s memory 1 From the operator Main Menu highlight Result History and press Select 14 03 21 14 11 14 03 21 14 15 Result History Result History Patient Results Patient Results Liquid QC Results Liquid QC Results QC Cassette Results QC Cassette Results Read Cassette Read Cassette Result History Screen NOTE The Result History menu
28. ails press Result List b C d e To print the result highlight Print Result and press Select To print all the test results stored in the Reader highlight Print All and press Select To send the result to a LIS system highlight Send Result and press Select To send all the test results to a LIS system highlight Send and press Select 4 6 2 Viewing Result Stored on a Test Cassette Perform the following steps to view an individual result stored on a Test Cassette 1 From the operator Main Menu highlight Result History and press Select Venaxis Inc L10019EN Rev 05 Page 47 APPYReader User Manual m 12 12 06 03 28 pm Result History Patient Results Liquid QC Results QC Cassette Results Read Cassette Result History Screen NOTE The Result History menu item is not available on the supervisor Main Menu screen If you are logged in as a supervisor select Change to Operator 2 Place the Test Cassette over the Reader keypad 3 Use 4 and V to highlight Read Cassette and press Select The Reader displays the Patient ID date time and test result for the result stored on the Test Cassette 13 03 18 06 16 pm Cassette Details Patient ID 123123 Assay 1 Result NEGATIVE WBC Entered 12 4 Time 06 15PM 13 03 18 Read Result on Cassette Screen 4 Use A and to review the result stored on the cassette 5 You can also press Print to print the result 47 Shutdown
29. al p 13 03 07 02 33 pm Reset O Assign O Skip To enter a RFID card choose Assign place your RFID card over the keypad and press Confirm RFID Screen NOTE The facility supplied RFID card must comply with ISO IEC 15693 If you do not want to assign an RFID use 4 and 7 to highlight Skip and press Confirm NOTE To delete this user s RFID return to the RFID screen and 4 use and v to highlight Reset Then press Confirm 6 After adding the first supervisor you can change Reader settings add more users or set up the LIS connection Refer to the appropriate section below for instructions Changing Reader Settings Connecting to the LIS Managing Users Supervisor users can modify the following Reader settings Language The language setting determines what language is displayed on the Reader screen and printouts To change see Changing the Language Data Entry Method The data entry method settings determine whether data can be entered using a barcode scanner and whether they can be entered manually To change see Changing Data Entry Method Settings Print Setting print setting determines whether test results are printed automatically upon completion of a patient test To change see Changing the Print Setting Logout Time The logout time setting is the duration of inactivity after which a user will be automatically logged out of the Reader To change see Changing Securi
30. battery compartment Used to insert prepared test and QC cassettes in the Reader Page 7 APPYReader User Manual Reader Back View 2 3 Reader Rear View 1 PS 2 Port Used to connect the optional barcode scanner accessory to the Reader 2 Ethernet Port Used to connect the Reader to the LIS network 3 AC Power Port Used to connect the AC power adapter to the Reader 4 SD Card Slot Used for importing and exporting information via the SD card 5 On Off Switch Used to turn the Reader on and off Venaxis Inc L10019EN Rev 05 Page 8 APPYReader User Manual 24 Understanding Screens and Menus Each screen is divided into three areas the header bar the content area and the soft keys m 01 25 10 02 35 pm Run Test Result History ii Maintenance Main Menu Screen The information displayed in each area is described below 2 4 1 Header Bar The dark blue bar at the top of the screen that provides the following information The icon at the far left indicates whether the user is logged in as a supervisor an operator number next to the user icon is the current Operator ID If the auto login setting is enabled the header bar shows Auto Login instead of the Operator ID date and time are shown to the right of the user information icon shown at the far right indicates whether the Reader is using AC or battery power This Indicates that The user is log
31. bled until that check is rerun and passes Test Lockout Screen 4 When the desired lock out setting is highlighted press Select to save this setting Note It is recommended to select QCC and LQC must pass 5 Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen 3 9 Changing Data Entry Method Settings Supervisor users can change data entry method settings The data entry method settings determine whether data can be input by an external barcode scanner and whether they can be input by manual entry Perform the following steps to change data entry method settings 1 Goto the Settings screen 2 Use and Y to highlight Data Entry Method and press Select 13 03 05 08 35 pm Data Entry Barcode Scanner Manual Entry Data Entry Method Screen 3 Perform the following steps to enable or disable use of the barcode scanner for data entry such as Patient ID LOC ranges a Use and Y highlight Set Barcode Scanner and press Select The selected radio button indicates the current setting Venaxis Inc L10019EN Rev 05 Page 26 APPYReader User Manual 13 03 05 08 39 pm Barcode Scanner 9 Enabled Disabled Set Barcode Scanner Screen b Use and to highlight the desired setting f you select Enabled a barcode scanner be used to enter data If you select Disabled a barcode scanner cannot be used to enter data c When th
32. c When the desired setting is highlighted press Select to save this setting d Press Back to return to the Set Login Logout screen 3 12 Connecting to the LIS The Reader can send test results to the LIS over an Ethernet connection Complete the following steps to set up the LIS connection 3 12 1 Setting Up the Network Connection Perform the following steps to set up the network connection If you are not using DHCP you need to obtain the IP address port number subnet mask and standard gateway for the Reader from your network administrator 1 Connect an Ethernet cable to the Reader by inserting one end of the cable into the Ethernet port in the back of the Reader 2 Connecting the Ethernet Cable 2 Connect the other end of the Ethernet cable to the LIS network 3 Goto the Settings screen 4 Use ang to highlight Network Setup and press Select to display the Network Setup screen Venaxis Inc L10019EN Rev 05 Page 30 APPYReader User Manual 01 07 10 03 27 pm Network Setup METBIOS name Show Network Settings Network Setup Screen 5 Use and Y to highlight Network Configuration and press Select mY A 13 03 14 07 35 am ud Network Configuration Manual Network Configuration Screen 6 The following options are available on the Network Configuration screen obtain the Readers IP address port number subnet mask and standard gateway automatically using DHCP use 4 and Y to h
33. cassette drawer Apply the test sample Close the drawer Main Menu Insert Cassette Screen Run Test 5 Remove the Test Cassette from its pouch and place it into the cassette drawer 6 Prepare the sample in accordance with the APPY1 Test Kit Instructions for Use and apply the sample to the Test Cassette port 7 Gently close the drawer The test will start automatically Test Cassette in Reader Drawer 8 The Reader displays the status of the test on the Run Test screen 03 18 05 49 pm Run Test Patient 123123 Remaining Time m s 01 01 C Reading Processing 8 41 90 Abort Test Run Test Screen 9 When the test is done you will be asked to enter the WBC or to confirm the WBC entered prior to the test Venaxis Inc L10019EN Rev 05 Page 43 APPYReader User Manual 04 43 pm Enter WBC Results Confirm WBC Results wec 15 51 wec 15 51 12 06 05 03 32 pm If WBC is not entered test will abort No results will be determined The test will need to be repeated WBC Results Screen IMPORTANT WBC must confirmed within 90 minutes or test is automatically aborted 10 Re enter the patient WBC and press Confirm 13 03 18 05 Test Result 123123 APPY1 NEGATIVE Low Risk For Appendicitis Test Result Screen N IMPORTANT The Test Cassette must remain in the Reader until the Patient ID is confirmed 11 Press Next and the following
34. could void the user s authority to operate the equipment Venaxis is a registered trademark of Venaxis Inc APPY1 and APPYReader are trademarks of Venaxis Inc L10019EN Rev 05 Venaxis Inc L10019EN Rev 05 Page 71
35. creen and printouts To change see Changing the Language Perform the following steps to review global settings 1 Press to display the Main Menu screen 2 If you are logged in as a Supervisor use A 13 03 07 12 54 pm rii Main Menu Main Menu amp Import Export Run Test a Settings ey Result History Gh Oper Administration hi Maintenance 15 Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 8 and to highlight Settings and press Select If you are logged in as an operator use and 99 to highlight Maintenance and press Select Venaxis Inc L10019EN Rev 05 Page 52 APPYReader User Manual 01 07 10 03 26 pm 13 03 07 02 04 pm Settings Maintenance MEC Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout MILI Supervisor Settings Screen Operator Maintenance Screen 3 you are logged as a supervisor use and v to highlight Device Info and press Select If you are logged as an operator use and v to highlight Settings and press Select A 12 02 07 02 00 pm 01 13 10 06 31 pm Device Info Settings Supervisor History Global Settings Global Settings Supervisor History Supervisor Device Info Screen Operator Settings Screen 4 Use and v to highlight Global Settings and press Select to display the Global Settings screen The Readers current settings are displa
36. determines what language is displayed on the Reader screen and printouts Perform the following steps to change the language 1 Goto the Settings screen Venaxis Inc L10019EN Rev 05 Page 24 APPYReader User Manual 13 03 05 07 01 pm Settings Set Date and Time Select Language Read Temperature LIS Reviewer Setup Set Login Logout Supervisor Settings Screen 2 Use and v to highlight Select Language and press Select 3 Use 4 and V to highlight the desired language 4 When the desired language is highlighted press Select to save this setting 5 Press Back to return to the supervisor Settings screen or press to return to the supervisor Main Menu screen 3 8 Changing the Test Lockout Supervisor users can change the Reader s test lockout settings The test lockout settings determine what tests must pass prior to running a patient test Perform the following steps to change the test lockout 1 Goto the Settings screen amp ang 7 to highlight Select Test Lockout and press Select amp Settings Printing Setup 13 03 06 11 22 Data Entry Method Device Info Delete Results Test Lockout Settings Screen 3 Use and to highlight the desired test lockout settings Venaxis Inc L10019EN Rev 05 Page 25 APPYReader User Manual 4 14 03 21 07 06 am Test Lockout O Daily QCC must pass O Disabled If a QCC or LOC check fails patient testing is disa
37. e desired setting is highlighted press Select to save this setting d Press Back to return to the Data Entry Method screen 4 Perform the following steps to enable or disable manual entry of the data a Use and 9 to highlight Manual Data Entry and press Select The selected radio button indicates the current setting 13 03 07 01 26 pm Manual Entry Enabled Allow Manual Entry Screen b Use and V to highlight the desired setting f you select Enabled data can be entered using the keypad If you select Disabled data cannot be entered manually c When the desired setting is highlighted press Select to save this setting d Press Back to return to the Data Entry Method screen or press to return to the supervisor Main Menu screen 3 10 Changing the Print Setting Supervisor users can change the print setting The print setting determines whether test results are printed automatically upon completion of a patient test Perform the following steps to change the Patient ID settings 1 Goto the Settings screen Venaxis Inc L10019EN Rev 05 Page 27 APPYReader User Manual 2 Use and Y to highlight Printing Setup and press Select er 12 12 05 05 58 pm Settings Read Temperature LIS Reviewer Setup Set Login Logout Network Setup Select Supervisor Settings Screen 3 Use and 7 to highlight the desired setting Printing Setup O Automatically Printing Setup
38. ear or cut the end of the new paper roll to form a straight edge Insert the paper roll into the printer so that the end of the paper comes from under the roll toward the Reader display as shown below Inserting the Paper Roll 4 To replace the printer cover insert the paper roller between the edge of the paper and the paper roll as shown below 5 Push down on the sides of the printer cover until you hear it snap into place Venaxis Inc L10019EN Rev 05 Page 57 APPYReader User Manual Replacing the Printer Cover Press The Reader feeds the paper so that it extends out the top of the printer 6 3 Replacing the Batteries IMPORTANT The Reader is designed to perform a limited number N of tests on a set of new batteries If you are using batteries turn the Reader off when not in use You can use the automatic Power Off Time setting to help preserve battery life The battery power level is indicated by the icon displayed at the top right of the Reader screen The battery icon is gradually filled with white as the batteries are discharged IMPORTANT Rechargeable batteries are authorized for use with the Reader However due to the nature of these types of batteries N it is expected they will require recharging more frequently The Reader does not contain a built in battery charger and rechargeable batteries must be recharged outside of the Reader To replace the batteries in the Reader 1 2 3 Ve
39. er AC adapter than the supplied power adapter may void the Reader warranty 3 2 Using an Optional Barcode Scanner A barcode scanner with a PS 2 interface can be used for entering data To use an optional barcode scanner plug the end of the barcode scanner cable into the PS 2 port in the back of the Reader Venaxis Inc L10019EN Rev 05 Page 15 APPYReader User Manual 3 3 Turning On the Reader The on off switch is located on the back of the Reader To turn on the Reader push the on off switch until the Initializing screen appears then release it The Reader displays a splash screen during startup then displays the Set Date screen Date and time must be set before running any quality control or patient samples ey Set Date Date format YYYY MM DD 13 03 07 12 56 pm Year 2013 Month 03 Day 07 Set Date Screen IMPORTANT Allow the Reader to warm up for at least 10 minutes before running any patient samples 34 Setting or Changing the Date and Time Perform the following steps to set or change the date and time 1 To set date and time when the Set Date screen is first displayed the Date Format field is highlighted Skip to Step 5 2 To change date and time press to display the supervisor Main Menu screen 13 03 07 12 54 pm irt xu n m Settings Gh Oper Administration m Change to Operator Supervisor Main Menu Screen IMPORTANT You must add the first superviso
40. est result Test results can be printed or sent to the LIS For more information on the APPY1 Test please refer to the APPY1 Test Instructions For Use 2 1 Kit Components The following components are included in the APPYReader Instrument Kit APPYReader Instrument QC Cassette 2 Universal Power Transformer Thermal Paper Rolls 2 Power Cord User Manual CD Plug Adapter Warranty Card Batteries 4 Start Up Guide Rubber Feet 2 Quick Reference Guide EV NOTE To order consumables accessories or replacement parts for your Reader contact your local distributor or Venaxis Technical Support Venaxis Inc L10019EN Rev 05 Page 6 APPYReader User Manual 2 2 Reader Front View 1 Printer Cover 2 Display 3 Eject Button 4 Paper Feed Button 5 Main Menu Button 6 Left Soft Key 7 Navigation Buttons 8 Right Soft Key 9 Numeric Keypad 10 Delete Button 11 Battery Cover 12 Drawer Venaxis Inc L10019EN Rev 05 Front View Covers the printer Shows screens for navigating entering data and reviewing data Used to eject the drawer Used to advance the paper roll Used to return to the Main Menu screen Used to select the option shown above the key on the display Used to navigate within menus and Reader screens Used to select the option shown above the key on the display Used to enter numbers and decimal points Used to delete the character to the left of the cursor Covers the
41. ged in as a supervisor The user is logged in as an operator The Reader is using battery power and the batteries are fully charged The battery icon is gradually filled with white as the battery life is depleted The AC power adapter is being used to power the Reader Venaxis Inc L10019EN Rev 05 Page 9 APPYReader User Manual 2 4 2 Content Area The content area is the light blue area occupying the majority of the Reader screen This area displays menu options settings and data When you are logged in as a supervisor the selected option is indicated by a yellow bar with black text When you are logged in as an operator the selected option is indicated by a blue bar with white text 13 03 07 12 54 pm 01 05 10 01 05 pm Main Menu Main Menu gi Settings ey Result History Oper Administration ii Maintenance Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 2 4 53 Soft Key Selections The soft key selections are the dark blue areas with white text displayed at the lower left and lower right of the Reader screen Some screens have two soft key selections while other screens have only one option To use a soft key selection press the soft key below the desired option 2 4 4 Selecting Menu Items Use navigation keys 4 to highlight the field Press the right soft key to select the item Use radio buttons to indicate the selected feature 13 03 22 10 44 am
42. he Reader The UV light causes fluorescent dye in the Test Cassette to emit energy as relative fluorescence units RFU Based upon lot and analyte specific calibration coefficients programmed onto an RFID tag in each individual Test Cassette the Reader uses the measured RFU to calculate specific protein marker concentrations in a test sample The concentrations of the two markers in combination with White Blood Cell count WBC values obtained from a hospital s hematology analyzer and entered into the dedicated Reader are used to determine the patients APPY1 Test result according to preprogrammed proprietary algorithm Venaxis Inc L10019EN Rev 05 Page 5 APPYReader User Manual APP YReader Instrument and APPY1 Test Cassette Each Test Cassette RFID chip identifies relevant parameters for evaluating the test results These parameters include Test name Assay specific calibration coefficients Expiration date Patient information is entered in the Reader either manually or using the optional barcode scanner The Test Cassette is placed in the Reader s drawer with the sample application area facing toward the user A patient test sample processed plasma is applied to the cassette sample application area and the drawer is closed to start the test The Reader reads the Test Cassette RFID chip and processes the test based on pre programmed settings The Reader measures the level of protein markers interprets and reports the t
43. ighlight DHCP Then press Select The Reader obtains the network information and displays the Network Setup screen To enter the Reader s address port number subnet mask and standard gateway manually use and Y to highlight Manual Then press Select a When the Manual Network Setup screen is first displayed the IP address field is highlighted Use the numeric keypad to enter the IP address for the Reader Then press VY to highlight the Port number field NOTE To delete the last character entered press b Use the numeric keypad to enter the port number for the Reader Then press Y to highlight the Subnet Mask field c Use the numeric keypad to enter the subnet mask for the Reader Then press 9 to highlight the Standard Gateway field d Use the numeric keypad to enter the standard gateway for the Reader Venaxis Inc L10019EN Rev 05 Page 31 APPYReader User Manual e Review the IP address port number subnet mask and standard gateway and confirm that the correct information is displayed If you need to change a setting use and Y to highlight the field then use the numeric keypad to make the necessary changes f Press Confirm to save these settings and return to the Network Setup screen 3 12 2 Providing LIS Settings Perform the following steps to configure the LIS reviewer settings for the Reader You need to obtain the IP address and port number for the LIS reviewer from your network adm
44. imitation Federal Communication Commission U S Authorized Representative in the European Community The device requires safe disposal in conformance with the WEEE Directive 2012 19 EU The polarity of the power supply tip is positive Manufacturer Class 1M UV LED Product Do not view directly with optical instruments Page 12 APPYReader User Manual 26 Safety Symbols The following symbols are used in this User Manual This A A 2 7 Safety Information indicates that BIOHAZARD WARNING A situation which if not avoided could result in a health risk to the user ELECTRICAL SHOCK WARNING A situation which if not avoided could result in electrical damage to the Reader or bodily injury to the user CAUTION OR WARNING A situation which if not avoided could result in incorrect operation or damage to the Reader Review the safety information below before using the Reader A A A A Venaxis Inc L10019EN Rev 05 CAUTION Use the Reader only in the operating environment specified For details see Product Specifications CAUTION To ensure proper operating temperature do not place the Reader near radiators bright sunlight heat registers stoves or other heat producing equipment WARNING Operate the Reader using only the power cord and power supply AC adaptor provided Connect the Reader to an earth grounded outlet that meets the product s power specifications Fo
45. ing Use v 4 press Confirm When preferred Operator Name is done highlight Done and press Confirm 13 03 05 09 24 pm Operator Name EB C DE 4 1 DM N ORG T U v Ww x Y z Clear all Enter Operator Name Screen 11 Use a and v to highlight Supervisor and press Confirm To assign a user as an operator use A and v to highlight Operator 14 03 21 13 49 Set Mode O Supervisor Set Mode Screen NOTE At least one supervisor must be created prior to assigning additional users 12 Use v to highlight desired Barcode The following options are available on the Barcode screen Venaxis Inc L10019EN Rev 05 Page 22 APPYReader User Manual 13 03 07 01 18 pm Barcode O Assign O Skip To enter a new Barcode choose Assign Use the barcode reader to read the barcode Barcode Screen a To assign a barcode for this user use 4 ang Y to highlight Assign then use the external barcode scanner to scan the barcode The Reader assigns the barcode and displays the RFID screen NOTE To delete this user s barcode return to the Barcode screen and use to highlight Reset Then press Confirm b Ifyou do not want to assign a barcode use 4 ang Y to highlight Skip and press Confirm 13 The Reader can be programmed to read the facility supplied RFID card The following options are available 14 To assign an RFID for this user use 4 a
46. ining Checklist SUGGESTED FORMAT Laboratory User Operator User ID Trainer Date Type of Process Operator Initials Reader Review supplied components and materials Power Supply Powercord batteries Install Printer Paper Use of User ID barcode or RIFD card 00000000000 Reader Warm Up 10 minutes 000000 Kit Use and Storage Identify expiration date and lot information Test Kit and Controls storage Test 2 8 C and Controls 20 C 10 0 QC Cassette Run QC Cassette Cassette frequency Every 24 hours Storage Foil pouch reusable Viewing and documenting results PASS FAIL QC log or send to LIS QC Cassette failure repeating and back up QC Cassette Controls Control 1 Controt2 o 1 Test Kit lot or shipment as needed NR RR refreeze Controls Ranges Card and entering values 000000000002 and mixing vortex Dragging or rimming te Rinsing pipette Complete resuspension of conjugate critical J Venaxis Inc L10019EN Rev 05 Page 66 APPYReader User Manual 60 second total QC sample preparation time limit Patient Sample Processing EDTA tube Mixing of Sample Invert 8 10 times Centrifuge 10 minutes at 1300 times g at a gt 45 angle _ Reader warmed up 10 minutes
47. inistrator 1 Goto the Settings screen 2 Use and Y to highlight LIS Reviewer Setup and press Select 13 03 05 08 23 pm LIS Settings Timeout 05 Reviewer IP Address 0 0 0 0 Port Number 0 Supervisor Settings Screen 3 When the LIS Reviewer Settings screen is first displayed the Set Timeout field is highlighted Use the keypad to increase or decrease the timeout for the LIS reviewer The timeout is the amount of time after which the Reader will stop trying to communicate with the LIS 4 When the desired setting is displayed in the Set Timeout field press Y to highlight the Reviewer IP Address field 5 Use the keypad to increase or decrease the IP address for the LIS reviewer Then press Y to highlight the Port Number field 6 Use the keypad to increase or decrease the port number for the LIS reviewer 7 Review the timeout IP address and port number and confirm that the correct information is displayed If you need to change a setting use 4 ang to highlight the field Then use the keypad to make the necessary changes 8 Press Confirm amp Exit to return to the supervisor Settings screen Venaxis Inc L10019EN Rev 05 Page 32 APPYReader User Manual 4 Daily Operations This section provides information on preparing the Reader for testing The following tasks must be completed prior to testing patient samples Reader must be powered user must log in to the Reader unless the Re
48. item is not available on the supervisor Main Menu screen If you are logged in as a supervisor select Change to Operator Venaxis Inc L10019EN Rev 05 Page 39 APPYReader User Manual 2 Highlight either QC Cassette results or Liquid QC Results and press Select The Reader displays the QC Lot 4 date time and test result for results in the Reader s memory starting with the most recent test Scroll through results using V 14 03 21 13 54 Result List ID Date Time Result D2B 2 13 06 05 14 50 Passed 1 02 2 13 06 05 10 26 Passed D1B 2 13 06 03 14 04 Passed D1A2 13 06 03 10 39 Passed Result List Screen 3 Use and Y to highlight the desired result and press Options A to display the Result List Options screen m A 13 03 19 09 38 am Result List Options ID Date Time Result 123123 13 03 13 01 20PM Show Details Send All Print All Result List Options Screen a To see the result details highlight Show Details and press Select Detailed LQC Result Detailed QC Cassette Lot amp 1 2 Assay Check Cassette Assay APPY1 Result Passed APPY1 4 3 Line 0 4078 Result Passed Line 1 7748 LQC Detailed Result Screen QCC Detailed Result Screen The following information is available on the Detailed Result screen Reader Serial Number The complete Patient ID recorded for the test Assay QC assay type that was performed APPY1 or Check Cassette Result
49. l bars of varying widths that each represent a digit from O to 9 Process of checking the accuracy of a measuring instrument by comparison of a result to a reference standard Quality Controls built into the Reader s software and or the Test Cassette User with operator access privileges which allows performance of day to day operations with the Reader Quality control QC refers to steps taken to make sure that a system is of sufficiently high quality The Venaxis APP YReader Instrument used to run the APPY1 Test Chemical substance that is used to create a reaction when combined with another substance for the purpose of analysis Radio frequency identification a data collection technology that uses electronic tags for storing data and allows automatic identification of items Unlike barcode technology RFID provides out of line of sight identification and operates at greater distances than barcode scanners Secure digital memory card An SD card is a small flash memory card used for portable storage of digital data that can be imported to and exported from the Reader User with Supervisor access privileges which allows performance of advanced Reader activities Device containing the necessary reagents that react with the patient sample Results are measured by the Reader to determine the specific chemical substances in the patient Page 65 APPYReader User Manual 10 Appendices 10 1 Operator Tra
50. meouts and press Select 5 13 03 07 01 30 pm T Set Timeouts Logout Time 99 min wv P Power Off Time 99 min ww setting of 0 minutes turns off this feature Power Off Time should be at least equal to Logout Time Set Timeouts Screen When the Set Timeouts screen is first displayed the Logout Time field is highlighted If necessary use and to increase or decrease the logout time Select a power off time of 0 minutes if you never want the Reader to automatically turn off When the desired logout time is displayed press to highlight the Power Off b Time field NorE Select a logout time of 0 minutes if you never want users to be automatically logged out of the Reader a c If necessary use and to increase or decrease the power off time d When the desired power off time is displayed press Confirm to save these settings 4 Perform the following steps to change the auto login setting a On the Set Login Logout screen use and V to highlight Auto Login and press Select Venaxis Inc L10019EN Rev 05 Page 29 APPYReader User Manual 13 03 05 08 32 pm Auto Login O Enabled Disabled Set Auto Login Screen b Use a and V to highlight the desired setting If you select Enabled users will not be required to enter a login and PIN to use the Reader If you select Disabled users will be required to enter a login and PIN to use the Reader
51. naxis Inc Turn the Reader off by pushing the on off button on the back of the Reader then releasing it Turn the Reader over so that the back of the battery cover is visible To remove the battery cover place your thumb in the middle of the cover and exert slight pressure as you slide it in the direction shown below Remove the old batteries Insert four size AA 1 5 volt batteries Be sure that the plus and minus signs on the batteries match the signs embossed in the battery compartment L10019EN Rev 05 Page 58 APPYReader User Manual Installing the Batteries 6 Replace the battery cover by positioning it at the edge of the battery compartment and sliding it into position 7 When you have completed battery installation and replaced the battery cover turn the Reader right side up IMPORTANT If the Reader does not power on after replacing the batteries verify that the batteries are lined up according to the symbols in the battery compartment Venaxis Inc L10019EN Rev 05 Page 59 APPYReader User Manual 7 Troubleshooting Tips Refer to the table below for instructions for troubleshooting problems Problem Condition Paper Jam Keypad or other keys do not work Reader will not turn on Reader is locked up Drawer Test Cassette is jammed Venaxis Inc L10019EN Rev 05 Corrective Actions 1 Remove the printer cover to reveal the paper compartment 2 Remove and reinsert the paper roll
52. ng W to highlight Assign Hold the user s RFID card over the Reader keypad then press Confirm The Reader assigns the RFID and displays the Operator Administration screen 13 03 07 02 33 pm O Assign O Skip To enter a RFID card choose Assign place your RFID card over the keypad and press Confirm RFID Screen NOTE The facility supplied RFID card must comply with ISO IEC 15693 a If you do not want to assign an RFID use and highlight Skip and press Confirm NOTE To delete this user s RFID return to the RFID screen and use and V to highlight Reset Then press Confirm Venaxis Inc L10019EN Rev 05 Page 23 APPYReader User Manual NOTE To continue adding additional users and or supervisors return to step 8 3 6 Changing Settings Supervisor users can change the Reader s settings Settings are changed from the Settings screen Perform the following steps to get to the Settings screen 1 Press to display the supervisor Main Menu screen 13 03 07 12 54 pm a Settings Oper Administration 12 Change to Operator Supervisor Main Menu Screen 2 Use to highlight Settings and press Select A 13 03 05 07 01 pm Settings Set Date and Time Select Language Read Temperature LIS Reviewer Setup Set Login Logout Settings Screen 37 Changing the Language Supervisor users can change the Reader s language setting The language setting
53. or for assistance The network connection cannot be configured Contact your network administrator for assistance The connection to the LIS was interrupted Try the operation again Page 61 APPYReader User Manual Error Message LIS Error LIS Connection Not Available LIS Error Reviewer Not Available Login Error Login Failed Multiple ID Tags Detected No ID Tag Detected No SD Card Found No Upgrade Available PIN Mismatch Printer Temperature High RFID Error SD Card Read Error SD Card Write Error Temperature Error Test Cannot Be evaluated Too Many Users Selected Used Cassette Venaxis Inc L10019EN Rev 05 Corrective Action The Reader failed to connect to the LIS Try again to establish the connection If the problem persists check the network settings or contact your network administrator for assistance The LIS is currently unavailable Try again to establish the connection If the problem persists contact your network administrator The operator RFID tag is invalid or unreadable Try again to log in holding the RFID card over the center of the keyboard Alternatively use the keypad to manually enter the Operator ID The Operator ID PIN combination is invalid Try again to log in Ensure that only one RFID chip is on or near the Reader Place the RFID over the keypad of the Reader and try again Alternatively use the keypad to manually enter the Operator ID Make sure
54. r details see Product Specifications WARNING The Reader is intended for indoor use only To reduce the risk of electrical shock always unplug the power supply from the AC power source following use Page 13 APPYReader User Manual Venaxis Inc L10019EN Rev 05 CAUTION Results are stored in the Reader memory for temporary backup purposes only and may be overwritten The Reader memory stores results for up to 500 patient test results When memory capacity is reached the most recent result automatically overwrites the oldest result WARNING When using the Reader observe universal safety and laboratory precautions follow laboratory operating procedures regarding personal protective equipment i e lab coats gloves and safety WARNING Handle and dispose of Test Cassettes in accordance with standard biohazard practices WARNING Do not remove external panels to access the interior of the Reader The Reader contains a Class 1M UV LED used to illuminate the Test Cassettes Class 1M UV LEDs are not considered to be hazardous when used as intended Page 14 APPYReader User Manual 3 Setting Up The Reader 31 Supplying Power to the Reader Connect the AC power adapter that was supplied with the Reader as follows 1 Connect the AC power adapter to a power outlet Connecting the AC Power Adapter 2 Insert the cylindrical end of the AC adapter into the back of the Reader N IMPORTANT Use of any oth
55. r user before you can N change any Reader settings See Adding the First Supervisor User NOTE Only supervisor users can use this feature If you are logged in as an operator select Maintenance gt Change to Supervisor 3 Use and to highlight Settings and press Select Venaxis Inc L10019EN Rev 05 Page 16 APPYReader User Manual Settings Select Language Read Temperature LIS Reviewer Setup Set Login Logout Supervisor Settings Screen 4 Use and to highlight Set Date and Time and press Select 13 03 07 12 56 pm D Set Date Year 2013 Month 03 07 Set Date Screen 5 Use 4 v to scroll through the following screen and printout date format options dd mm yyyy Select this option to display the day then the month then the year with periods used as separators mm dd yyyy Select this option to display the month then the day then the year with slashes used as separators yyyy mm dd Select this option to display the year then the month then the day with slashes used as separators When the preferred date format is displayed press P to highlight the Year field 6 To setthe year month and day use 4 and to highlight the respective field Use 4 ang 7 to change the setting 7 When you have confirmed that the correct date is displayed press Confirm 13 03 07 01 00 pm Set Time Time format 12h v Hour 01
56. rvisor See Connecting to the LIS 4 3 1 Running the QC Cassette 1 If you are logged in as a supervisor go to the Main Menu and change to operator 2 From the Main Menu highlight Maintenance and press Select Venaxis Inc L10019EN Rev 05 Page 34 APPYReader User Manual 14 03 21 06 45 am Maintenance Settings Check APPYReader Change to Supervisor Maintenance Screen 3 Use and v to highlight Check APPYReader and press Select D 12 12 06 01 00 pm Check AppyReader Control 1 Control 2 QC Cassette Check APPYReader Screen 4 Use a and v to highlight QC Cassette and press Select 5 The Reader drawer will open and the Insert Cassette screen will be displayed 12 12 05 06 20 pm Insert Cassette Insert QC Cassette into the drawer Close the drawer Back Insert QC Cassette Screen 6 The APPYReader QC Cassette screen is displayed when the test finishes 13 03 14 07 38 am APPYReader QC Cassette Line 0 3699 Line 1 7264 Result Passed Back Options APPYReader QC Cassette Result Screen 7 QC cassette result options a Press Options Venaxis Inc L10019EN Rev 05 Page 35 APPYReader User Manual 13 03 14 07 39 am APPYReader QC Cassette Line 0 3699 Line 1 7264 Result Send All Print All APPYReader QC Cassette Options Screen b To print the result Use z 4 to highlight Print Result and press Select To print all of
57. s Back to return to the previous screen or press to return to the Main Menu screen Venaxis Inc L10019EN Rev 05 Page 51 APPYReader User Manual 53 Reviewing Global Settings Supervisor users and operator users can review a summary of the following Reader settings Logout Time The logout time setting is the duration of inactivity after which a user will be automatically logged out of the Reader To change see Changing Security and Power Saving Settings APO Time The automatic power off time is the duration of inactivity after which the Reader will automatically turn off To change see Changing Security and Power Saving Settings Auto Login The auto login setting determines whether users are required to enter a login and PIN to use the Reader To change see Changing Security and Power Saving Settings Immediate Print The immediate print setting determines whether test results are printed automatically upon completion of a patient test To change see Changing the Print Setting Manual Data Entry The manual data entry setting determines whether data can be entered manually To change see Changing Data Entry Method Barcode Scanner The barcode scanner setting determines whether data can be entered using a barcode scanner To change see Changing Data Entry Method Serial Number The serial number for the Reader is available on this screen Language The language setting determines what language is displayed on the Reader s
58. screen will appear 13 03 05 04 17 pm Confirm Patient ID Please confirm that the displayed patient ID is correct or enter the correct ID below Confirm Patient ID Screen 12 To confirm that the entered Patient ID is correct on the above screen you must do one of the following Venaxis Inc L10019EN Rev 05 Page 44 APPYReader User Manual If the displayed Patient ID is correct press Confirm to view the test result on the Result List screen If the Reader s automatic printing feature is enabled the result is printed automatically 13 03 19 09 37 Result List ID Date Time Result 123123 13 03 13 01 20PM 13 03 08 09 43AM BZQX 13 03 08 09 33AM Notestr UBKX 13 03 08 09 23AM NEGATIV Result List Screen If the displayed Patient ID is incorrect a Enter the correct Patient ID and press Confirm to display the Patient ID does not match screen 13 03 05 04 44 pm ID Mismatch Original Patient ID Re entered ID Please confirm the Patient ID and re enter using keypad Patient ID Does Not Match Screen b Review the displayed Patient IDs and re enter the correct Patient ID Press Confirm to view the test result on the Result List screen 13 Press 4 to eject the drawer Remove the Test Cassette and dispose store as appropriate 46 Managing Patient Results The Result List screen displays basic information for each patient test res
59. so that the end of the paper comes from under the roll toward the Reader display 3 Replace the printer cover 4 Press to advance the paper 5 If the error continues contact Technical Support for assistance Reset the Reader by disconnecting the AC power adapter from the Reader or removing the four batteries Wait 30 seconds and reconnect the power adapter or reinsert the batteries Ensure that the AC power adapter is connected securely to the Reader and to the power outlet or that the four batteries are installed correctly If the problem continues connect the AC power adapter to a different power supply or replace the four AA batteries with all new batteries Reset the Reader by disconnecting the AC power adapter from the Reader or removing the four batteries Wait 30 seconds and reconnect the power adapter or reinsert the batteries Do not pull or force the drawer Test Cassette out of the Reader Reset the Reader by disconnecting the AC power adapter from the Reader or removing the four batteries Wait 30 seconds and reconnect the power adapter or reinsert the batteries If you are still unable to open the drawer and or remove the Test Cassette contact Technical Support Page 60 APPYReader User Manual Understanding Error Messages Refer to the table below for instructions for responding to error messages Error Message Barcode Scan Failed Battery Low Battery Too Low Empty Paper Tray Expired Cassette
60. t 1 5 VDC Operating Environment Altitude 0 to 2000m Temperature 15 C to 30 C Humidity 30 to 80 non condensing Temperature 20 C to 55 C for 24 hours Humidity 25 to 85 non condensing External Barcode Scanner optional Connector PS 2 Power 5 VDC lt at 300 mA Codes Supported Any 1D code 20 characters or less in length Model Dialogic Touch 65 or equivalent Network Connectivity optional Connector RJ45 Communications 10 100 BASE T using TCP IP Data Protocol POTC 1 A2 8 1 Returning the Reader IMPORTANT Contact your local distributor or Venaxis Technical Support for return authorization instructions 8 2 Disposing of the Reader In conformance with the WEEE Waste Electrical and Electronic Equipment Directive do not dispose of this product in municipal waste Please contact your local distributor to arrange disposal and recycling Venaxis Inc L10019EN Rev 05 Page 63 APPYReader User Manual 83 Accessories and Part Numbers The following are optional accessories for the Reader APPYReader Barcode Scanner PS 2 F10010 Venaxis Inc L10019EN Rev 05 Page 64 APPYReader User Manual 9 Glossary Assay Barcode Scanner Calibration Internal QC Operator QC Reader Reagent RFID SD Card Supervisor Test Cassette Venaxis Inc L10019EN Rev 05 Test to determine the presence of a substance Scanning device that can interpret a barcode a series of vertica
61. the QC cassette results stored in the Reader highlight Print and press Select d To send the result to a LIS system highlight Send Result and press Select MR 12 09 19 02 47 pm Sending Result Establishing connection Cancel QC Cassette Result Sending to LIS Screen e To send all of the QC cassette results to a LIS system highlight Send All and press Select IMPORTANT The QC cassette is REUSABLE and should NOT be N discarded until the end of its useful life Avoid light exposure and reseal and store the QC cassette in its original pouch immediately after each use 4 3 2 Running Liquid Quality Control QC N IMPORTANT Allow the Reader to warm up for at least 10 minutes before running any QC samples 1 If you are logged in as a supervisor go to the Main Menu and change to operator 2 From the operator Main Menu highlight Maintenance and press Select Venaxis Inc L10019EN Rev 05 Page 36 APPYReader User Manual 14 03 21 06 45 Maintenance Settings Check APPYReader Change to Supervisor IIIS Maintenance Screen 3 Use and v to highlight Check APPYReader and press Select 12 12 06 01 00 Check AppyReader Control 1 Control 2 QC Cassette Check APPYReader Screen 4 Use and v to highlight Control 1 or Control 2 and press Select 12 06 05 03 08 pm Insert Cassette Place a test cassette in the cassette drawer Apply the test sample Close
62. the drawer Insert Cassette Screen Liquid Control 5 Remove the Test Cassette from its pouch and place it into the cassette drawer 6 Prepare the control sample in accordance with the APPY1 Control Kit Instructions for Use and apply the sample to the Test Cassette port 7 Gently close the drawer The test will start automatically Venaxis Inc L10019EN Rev 05 Page 37 APPYReader User Manual 13 03 18 06 38 pm Run Test Patient Liquid QC 1 Remaining Time m s 01 15 Reading Processing amp 27 Abort Test Liquid Control Testing Screen 8 You will be prompted to enter the QC lot number after the test completes in about 11 minutes 13 03 05 06 46 pm Control 1 Lot Enter Control 1 Lot using the barcode scanner or the keypad Enter Control Lot Screen 9 Use the keypad or optional barcode scanner to enter the QC lot number and press Confirm 13 03 05 06 47 pm Control 1 Ranges CRP Range from Ss ug mL to ug mL MRP Range from ug mL to ug mL Enter using the keypad or scan with a barcode reader Confirm Enter Control Ranges Screen 10 Use the keypad or optional barcode scanner to enter the lot specific QC ranges and press Confirm 13 03 18 06 51 pm Result for Control 1 LOC Lot 130021 CRP Result 7 32 Pass Result 0 46 Pass Control Result Screen 11 Press Next to return to the Check APPYReader screen Venaxis Inc L10019EN Rev 05 P
63. ty and Power Saving Settings Power Off Time The power off time is the duration of inactivity after which the Reader will automatically turn off To change see Changing Security and Power Saving Settings Venaxis Inc L10019EN Rev 05 Page 20 APPYReader User Manual Auto Login Setting The auto login setting determines whether users are required to enter a login and PIN to use the Reader To change see Changing Security and Power Saving Settings NOTE Only supervisor users can change Reader settings you are logged as an operator select Maintenance gt Change to Supervisor to change settings 7 Upon initial supervisor setup skip to step 8 To add additional users press to display the Supervisor Main Menu screen Use and to highlight Oper Administration and press Select 14 03 21 11 51 Main Menu Import Export m Settings Change to Operator Supervisor Main Menu Screen 8 Use and to highlight Create new ID and press Select 14 03 21 11 52 D Operator Administration Organize IDs Free Entries 99 Maintenance Screen 9 Enter a four digit Operator ID and four digit PIN using the keypad and press Confirm 13 03 07 01 16 Enter Operator ID Opto PIN Confirm PIN Enter Operator ID Screen Venaxis Inc L10019EN Rev 05 Page 21 APPYReader User Manual NOTE To delete the last character entered press c 10 Enter Operator Name us
64. ult stored in the Reader s memory From the Result List screen you can view details for a patient test result send patient test results to the LIS print patient test results You can also view send and print an individual result stored on a Test Cassette NOTE To send a patient result to the LIS the Reader must be connected to the LIS and the LIS must have been set up by a supervisor See Connecting to the LIS for instructions Venaxis Inc L10019EN Rev 05 Page 45 APPYReader User Manual IMPORTANT The Reader can store up to 500 patient test results When the Reader s memory is full a warning message is displayed prompting user action If no action is taken results overwritten as new tests are completed starting with the oldest result in memory 4 6 1 Viewing Test Results in Reader Memory Perform the following steps to view detailed information for test results stored in the Reader s memory 1 From the operator Main Menu highlight Result History and press Select A 12 12 06 03 28 pm Result History Patient Results Liquid QC Results QC Cassette Results Read Cassette Select Result History Screen NOTE The Result History menu item is not available on the supervisor Main Menu screen If you are logged in as a supervisor select Change to Operator 2 Highlight Patient Results and press Select The Reader displays the Patient ID date time and test result for results
65. yed You can scroll through settings using and v 13 03 05 08 46 pm Global Settings Logout Time Power Off Time 99 min Auto Login Disabled Immediate Print Disabled Manual Entry Enabled Global Settings Screen 5 f you want to print the global settings press Print 6 Press Back to return to the previous screen or press to return to the Main Menu screen Venaxis Inc L10019EN Rev 05 Page 53 APPYReader User Manual 5 4 Deleting Stored Test Results Supervisor users can delete test results stored in the Reader s memory IMPORTANT Test results cannot be retrieved from the Reader after they are deleted Before you delete any test results make sure that you have archived the results appropriately Perform the following steps to delete stored test results 1 Goto the supervisor Settings screen 2 Use and Y highlight Delete Results and press Select 13 12 12 05 18 pm D Delete Results Delete Liquid QC Result Delete QC Cassette Delete Results Screen 3 Select Delete Patient Result to delete a patient test The Reader displays the Patient ID date time and test result for tests in the Reader s memory starting with the most recent test performed You can scroll through results using a V 13 03 14 07 58 am Delete Results ID Date Time Result cWWD 13 03 08 09 13AM 123123 01 01 01 12 00AM INCONC 4489 01 01 01 12 00AM

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