pex User Manual - APPY International
Contents
1. b Ifyou do not want to assign a barcode use a and v to highlight Skip Then press Confirm amp Next amp u A 13 03 07 02 33 pm RFID O Assign O Skip To enter a RFID card choose Assign place your RFID card over the keypad and press Confirm RFID Screen 13 If the facility uses RFID cards for laboratory personnel the reader can be programmed to read the facility supplied RFID card The following options are available on the RFID Screen NOTE The facility supplied RFID card must comply with ISO IEC 15693 a To assign an RFID for this user use amp and to highlight Assign Hold the users RFID card over the reader keypad then press Confirm The reader assigns the RFID and displays the Operator Administration screen a W b Ifyou do not want to assign an RFID use a and W to highlight Skip Then press Confirm Venaxis Inc Page 21 APPYReader User Manual NOTE To delete this user s RFID return to the RFID screen and use a and Vv to highlight Reset Then press Confirm 14 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 m Changing Reader Settings m Managing Users Connecting to the LIS Supervisor users can modify the following reader settings m Language m Data Entry Method m Print Setting m Logout Time Power Off Time m Auto Login Settin2. VENAXIS 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 Illustrations including software screen illustrations are representative and may not reflect the most recently released updates Copyright 2013 Venaxis Inc All rights reserved wl Venaxis Inc Emergo Europe 1585 South Perry Street Molenstraat 15 Castle Rock CO 80104 2513 BH The Hague USA The Netherlands www venaxis com Tel 1 303 794 2000 Fax 1 303 798 8332 CE For U S Export Only Distributor To locate a distributor in your region please visit Venaxis com Venaxis Inc Page 2 APPYReader User Manual Table of Contents 1 HOWTO USE THIS MANUAL ne 5 Z READER OVER VIEW icacscecacsracacndececesa dacmsaenescorecedudndnceceaeguonnsnanenneuludads ce ka anon nn AN rena 5 2 1 ECONP ONENE arrin A E E E E tents T aces sumer Ga eas E A T E AN teen 6 2 2 READER FRONT VIEW orisiirisii acess aie see AE TO ante E TET EN EEO AE TE E TES E AE TEATE 7 2 3 READER REAR VIEW ni ea A E E E nba han 8 2 4 UNDERSTANDING
3. to increase or decrease the port number for the LIS reviewer Review the timeout IP address and port number and confirm that the correct information is displayed If you need to change a seiting use 4 and gt to highlight the field Then use and to make the necessary changes Press Confirm amp Exit to return to the supervisor Settings screen 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 The reader must be powered on A user must log in to the reader unless the reader s auto login feature is enabled Quality control must be performed as required by laboratory procedures 4 1 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 The Enter Patient ID screen is displayed if the reader s auto login feature is enabled NN IMPORTANT Allow the reader to warm up for at least 10 minutes before running any patient samples 4 2 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 usi
4. APPYReader User Manual 3 9 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 2 Use S and W to highlight Printing Setup and press Select 12 12 05 05 58 pm Settings Read Temperature LIS Reviewer Setup Set Login Logout Network Setup in an Supervisor Settings Screen 3 Use S ana W to highlight the desired setting f bovoooos 01 08 10 09 10 pm Printing Setup O Automatically Printing Setup Screen o If you select Automatically test results will be printed automatically upon completion of a patient test o Ifyou 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 Venaxis Inc Page 26 APPYReader User Manual 3 10 Changing Security and Power Saving Settings Supervisor users can change the following security and power saving settings m Logout Time The logout time setting is the duration of inactivity after which a user will be automatically logged out of the reader Power
5. Date format YYYY MM DD Year 2013 a a Month 03 Day 07 Set Date Screen 5 Use a and Y to scroll through the following screen and printout date format options m 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 gt to highlight the Year field 6 Toset the year month and day use lt 4 and gt to highlight the respective field Use amp and W to change the setting 7 When you have confirmed that the correct date is displayed press Confirm amp Next Venaxis Inc Page 17 APPYReader User Manual 13 03 07 01 00 pm Set Time Time format 12h v a Hour O1 PM Minute 00 v E Set Time Screen 8 Use ana Y to toggle between the following screen and printout time format options m 12h Select this option to display times in the 12 hour time format with a m and p m m 24h Select this option to display times in the 24 hour time format When the preferred time format is displayed press gt to highlight the Hour field 9 Toset the hour and minute use 4 and gt to highlight the respective field Use and Y to change the setting 10 When the
6. Page 19 APPYReader User Manual One Time 12 12 05 05 18 pm Create a Supervisor You will be guided in creating at least one Supervisor Create a Supervisor Confirmation Screen 5 Press OK amp 13 03 07 01 16 nm Enter Operator ID Op 1D PIN Confirm PIN Enter Operator ID Screen 6 Use the numeric keypad to enter the ID for the first supervisor The ID must be 4 digits NOTE To delete the last character entered press K 7 Use the numeric keypad to enter the user PIN The PIN must be 4 digits 8 Use the numeric keypad to confirm the user PIN 9 Press Confirm amp Next 13 03 05 09 24 pm Operator Name ABCDEFGHIJKLMN Q Q RS TUW WAY amp Clear all Enter User Name Screen 10 Enter the user name 11 Use a v 4 and Do highlight Done Then press Confirm amp Next Venaxis Inc Page 20 APPYReader User Manual Barcode O Assign O Skip To enter a new Barcode choose Assign Use the barcode reader to read the barcode Back Barcode Screen 12 The following options are available on the Barcode screen a To assign a barcode for this user use and W 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 and to highlight Reset Then press Confirm amp Next JE N
7. 7 Safety Information This Icon 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 Venaxis Inc A A A AN 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 eguipment 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 For 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 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
8. 8 3 Accessories and Part Numbers The following are optional accessories for the reader e APPYReader Barcode Scanner PS 2 F10010 Venaxis Inc Page 65 APPYReader User Manual 9 Glossary Assay Barcode Scanner Calibration Internal QC Operator AC Reader Reagent RFID SD Card Supervisor Test Cassette Venaxis Inc Test to determine the presence of a substance Scanning device that can interpret a barcode a series of vertical bars of varying widths that each represent a digit from 0 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 readers 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 APPYReader 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
9. 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 LQC ranges a Use and W to highlight Set Barcode Scanner and press Select Venaxis Inc Page 24 APPYReader User Manual The selected radio button indicates the current setting 13 03 05 08 39 pm Barcode Scanner Enabled O Disabled Set Barcode Scanner Screen b Use and a to highlight the desired setting If you select Enabled a barcode scanner can be used to enter data If you select Disabled a barcode scanner cannot be used to enter data c When the 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 S and W to highlight Manual Data Entry and press Select The selected radio button indicates the current setting 13 03 07 01 26 pm fy Manual Entry Enabled Disabled a Allow Manual Entry Screen b Use Mani to highlight the desired setting If 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 Venaxis Inc Page 25
10. 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 Go to the Settings screen 2 Use S and Y to highlight Set Login Logout and press Select 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 Sand W to highlight Set Timeouts and press Select Venaxis Inc Page 27 APPYReader User Manual 13 03 07 01 30 pm Set Timeouts a Logout Time 99 min vw a Power Off Time 99 min v A setting of O minutes turns off this feature Power Off Time should be at least equal to Logout Time E Set Timeouts Screen When the Set Timeouts screen is first displayed the Logout Time field is highlighted If necessary use amp and to increase or decrease the logout time NotTE Select a logout time of 0 minutes if you never want users to be automatically logged out of the reader b When the desired logout time is displayed press B8 io highlight the Power Off Time field NoTE Select a power off time of 0 minutes if you never want the reader to automatically turn off c If necessary use and to
11. THE na ne baba 64 8 2 DISPOSING OF THE An Nr An NU AA AA aa NA AA NA AA AAA SA AA 65 8 3 ACCESSORIES AND PART NUMBERS acre aero er Tee enaA NENE EEEE AEAEE 65 S GLOSSARI en em ne nn 66 Venaxis Inc Page 4 APPYReader User Manual 1 iv 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 For example Use 4 and V 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 cassette avoid light exposure Store and reseal the QC cassette in its original pouch immediately after each use 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 the reader The UV light causes fluorescent dye in the test cassette to emit energy as relative
12. batteries or connect the AC power adapter Try again to print Battery Too Low Replace the readers 4 AA batteries or connect the AC power adapter Empty Paper Tray Replace the paper roll in the reader Expired Cassette Remove the expired test cassette and repeat the test with a new test cassette ID Already Exists The selected operator ID is already in use Enter a different 4 digit operator ID Invalid One Time PIN 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 Invalid Patient ID The patient ID must be 1 to 15 digits Try again to enter the patient ID Invalid Op ID The operator ID must be 4 numbers Try again to enter the operator ID LAN Error Cannot Get IP The DCHP server is not responding with an IP address Contact Address your network administrator for assistance LAN Error Network The network connection cannot be configured Contact your Cannot Be Configured network administrator for assistance LIS Error LIS Connection The connection to the LIS was interrupted Try the operation Interrupted again Venaxis Inc Page 62 APPYReader User Manual Error Message LIS Error LIS Connection Not Available LIS Error Reviewer Not Available Login Failed Multiple ID Tags Detected No ID Tag Detected No SD Card Found No Upgrade Available PIN Mismatch Pri
13. field d Use the numeric keypad to enter the standard gateway for the reader 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 Ba and Y to highlight the field then use the numeric keypad to make the necessary changes e Press Confirm to save these settings and return to the Network Setup screen 3 11 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 administrator 1 Go to the Settings screen 2 Use and 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 SW and 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 Venaxis Inc Page 31 APPYReader User Manual Venaxis Inc When the desired setting is displayed in the Set Timeout field press gt to highlight the Reviewer IP Address field Use and to increase or decrease the IP address for the LIS reviewer Then press gt to highlight the Port Number field Use and
14. 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 patient s APPY1 Test result according to a preprogrammed proprietary algorithm Venaxis Inc Page 5 APPYReader User Manual APPYReader Instrument and APPYI 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 test result Test results can be printed sent to the LIS or exported to an optional SD card 2 1 Kit Comp
15. 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 VY to highlight Set Auto Login and press Select Venaxis Inc Page 28 APPYReader User Manual 13 03 05 08 32 pm Auto Login O Enabled Disabled Set Auto Login Screen b Use S and W 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 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 11 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 11 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 Connecting the Ethernet Cable Venaxis Inc Page 29 APPYReader User Manual 2 Co
16. 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 Venaxis Inc Page 57 APPYReader User Manual 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 Replacing the Printer Cover 6 Press The reader feeds the paper so that it extends out the top of the printer Venaxis Inc Page 58 APPYReader User Manual 6 3 Replacing the Batteries IMPORTANT The reader is designed to perform a limited number of tests NN 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 it is NN expected they will reguire recharging more freguently 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 Turn the reader off by pushing the on off button on th
17. you press Skip you will be asked to enter the patient WBC after the test 12 12 06 02 31 prm Insert Cassette Place a test cassette in the 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 y LI gt Ga Test Cassette in Reader Drawer Venaxis Inc Page 41 APPYReader User Manual 8 The reader displays the status of the test on the Run Test screen 3 03 18 05 49 pm Run Test Patient 123123 Remaining Time m s 01 01 an Reading Processing 3 41 Abort Test 9 When the test is done you will be asked to enter the WBC or to confirm the WBC entered prior to the test fal 12 06 05 03 32 pm Enter WBC Results Confirm WBC Results wec Pics wec Pics If WBC is not entered test will abort Mo results will be determined The test will need to be repeated 4 IMPORTANT WBC must be confirmed within 90 minutes or the test is automatically aborted 10 Re enter the patient WBC and press Confirm 13 03 18 05 51 prm Test Result 123123 APPY1 NEGATIVE Low Risk For Appendicitis Test Result Screen 4 IMPORTANT The test cassette must remain in th
18. 12 54 pm m3 Settings th Oper Administration I8 Change to Operator Supervisor Main Menu Screen Set Date and Time Select Language Read Temperature LIS Reviewer Setup Set Login Logout Settings Screen 3 7 Changing the Language Supervisor users can change the reader s language setting The language setting determines what language Is displayed on the reader screen and printouts Perform the following steps to change the language 1 Go to the Settings screen Venaxis Inc Page 23 APPYReader User Manual 13 03 05 07 Olpm Settings Select Language Read Temperature LIS Reviewer Setup Set Login Logout Pemain Menu Supervisor Settings Screen 2 Use and P to highlight Select Language and press Select 3 Use S and W 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 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 Go to the Settings screen 2 Use S and W to highlight Data Entry Method and press Select Data Entry F REA A a Manual
19. 2 Running Liguid Quality Control na binasa aa 37 4 4 TESTING APATIENT SA ME nan 40 4 5 MANAGING PATIENT Re ES no oa Ma nun naa 44 4 5 1 Viewing Test Results in Reader MEMOTY ooo oo Wo mma 44 4 5 2 Viewing a Result Stored on a Test Cassette micananceteman tmn than nasa aka kan kan ian ana 46 Venaxis Inc Page 3 APPYReader User Manual 4 6 NONA NN NA DN AA SA AA NE AA NA talon AN an NN PA NN SA NA SA NAN AA TA 47 5 REVIEW READER INFORMATION ccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccccssccccccccscccecs 48 5 1 CHECKING THE SOFTWARE VERSION enno to E TEE ET Ge anna 48 5 2 REVIEWING THE SUPERVISOR HISTORY oo elsa ea na SANAAA ESENIN in ane nan nee Ki 50 5 3 REVIEWING GLOBAL SETTINGS ccccccccccccccccccccccccccceeeeeccnunaccceeeeeeeeeecnuauceeeeeeeeeeeenscaaeeeeeeeeeeeeenscaaeeeeeeeeeeeeencuaeeeeeeeeess 51 5 4 DELETING STORED TEST RESULTS cccicct snnaitauiiedwdveswosmncesacitnsieenesanied Rea anna as aan ee aa raba ala naa na Rea 54 6 MAINTAINING THE nana 56 6 1 CLEANING TIE READE a ET EE A TA eo vas de eee cee tes 56 6 2 CHANGING THE PAPER an i aaa 56 6 3 REPLACING THE BA Ne nana EETA 59 7 TROUBLESHOOTING TIPS sessssosssssssososessssessssssssssssssosessssessssessssosssssssssssessssessosossssosssssosssosesssosssssossssosesso 61 7 1 UNDERSTANDING ERROR MESSAGE Soe sn na ea en bana BAN Sae aon nenen Nan Pesanan On aan 62 8 SYSTEM SPECINCA NON Ke Rae Ka EENE ETENE 64 8 1 RETURNING
20. Inc Page 48 APPYReader User Manual 01 07 10 03 26 pm A 13 03 07 02 04 pm Settings Maintenance setoateondtine Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout Sain on Main Won Supervisor Settings Screen Maintenance Screen 3 If you are logged in as a supervisor use a and v to highlight Device Info and press Select If you are logged in as an operator use a and v to highlight Settings and press Select AA 04 JA ii 120207 02 00 pm m 01 13 10 06 31 pm Device Info Settings Supervisor History Global Settings Global Settings Supervisor History Device Info Screen Operator Settings Screen 4 Use a and v to highlight Software Version and press Select The version information for the reader s software is displayed 13 03 06 10 17 am 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 Venaxis Inc Page 49 APPYReader User Manual 5 2 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 fi 01 05 10 01 05 pm Main Menu Main Menu a Settings Ey Result His
21. P Range from ug mL to ug mL Enter using the keypad or scan with a barcode reader Enter Control Ranges Screen 10 Use the keypad or optional barcode scanner to enter the QC ranges and press Confirm Venaxis Inc Page 39 APPYReader User Manual 13 03 18 06 51 pm Result for Control 1 LOC Lot 130021 CRP Result 7 32 Pass MRP Result 0 46 Pass Control Result Screen 11 Press Next to return to the Check APPYReader screen 12 Press amp to eject the drawer Remove the test cassette and dispose or store as appropriate 4 4 Testing a Patient Sample N 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 A and Y to highlight Run Test and press Select 12 12 06 02 23 pm Enter Patient ID Enter a patient ID using the barcode scanner or using the keypad Confirm 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 Venaxis Inc Page 40 APPYReader User Manual m i 13 03 07 01 43 pm Enter WBC Results wec JP 02 51 Push Skip if WEC Is not available WBC can be entered later sk Enter WBC Result Screen 4 If the patient WBC result is available enter it and press Confirm Otherwise press Skip If
22. Patient 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 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 IMPORTANT The reader can store up to 500 patient test results When N the reader s memory is full a warning message is 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 5 1 Viewing Test Results in Reader Memory Perform the following steps to view detailed information for test results stored in the readers memory 1 From the operator Main Menu highlight Result History and press Select m A 12 12 06 03 28 pm Result History Patient Results Liquid QC Results QC Cassette Results Read Cassette Result History Screen Venaxis Inc Page 44 APPYReader User Manual N 2 3 Venaxis Inc 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 Highlight Organize Re
23. SCREENS AND MEN na 9 2 4 1 FHC OG aa 9 2 4 2 COMENT ATO acca an aa NN an NE aa NN NN nea cies 10 2 4 3 Ne GG sa eo ad Keamanan oO Mn oon Na PRA 10 2 4 4 Seng Menu fn nT oS Or SE roe eee 10 2 4 5 ECHO ee anna nee dab 11 2 5 UNDERSTANDING LABELING SYMBOLS Pn aa an aes 12 2 6 ta aan na na na Pn nese egase 13 2 1 SAE NORMA ON na 13 3 SEING UP THE READER oem 15 3 1 SUPPLYING POWER TO THE READER aa nie pages at on ee ieee na en aa 15 3 2 USING AN OPTIONAL BARCODE SCANNER caicecnssscrsenkunewaqnesomeseseatesanstanssacnussseanas veueautusaseansbontteaswacdeqns aces nok Komen abs 15 3 3 TORNING ON THE BR aa 15 3 4 SETTING OR CHANGING THE DATE ANDI ME E E EN T E ai 16 3 5 ADDING THE FIRST SUPERVISOR USER AND ADDITIONAL USERS coco Woo Ja 18 3 6 CAN NN E E E A 22 3 7 GHANGING THE ANA Be AE NEEESE E EA E ns oe EEA RREN 23 3 8 CHANGING DATA ENTRY METHOD SETTINGS ssssssssseseessresssrrssresssrrserrsesrrseresesreserrsesresereresrrserrresrrseerresreseerreereseene 24 3 9 CHANGING THE eNotes fetes teehee eri aa oa EEE E Dan 26 3 10 CHANGING SECURITY AND POWER SAVING SETTINGS si otisw anak aan EENET ETEEN ES 27 Sl CONNECTING TOTHE LID arene ionn T E E EEE E T ETETE ET E 29 3 11 1 Setting Up the Network Connection Gea esesee ea eseseeeeaeaesesesesaeaesessneaees 29 Sel Providing Leg an rear a 31 4 DAN OPERA ON nee 33 41 TORNING ON AD ana 33 4 2 LG GING E E E a 33 4 3 EN RE ne ee eee eee rere 34 4 3 1 Running e ea asal anon ae Teen 35 4 3
24. age The language setting determines what language is displayed on the reader screen and printouts To change see Changing the Language Perform the following steps to review global settings 1 Press to display the Main Menu screen nA 13 03 07 12 54 pm mn Main Menu Main Menu a Settings Cw Result History Gh Oper Administration ini Maintenance IS Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 2 If you are logged in as a supervisor use and VY to highlight Settings and press Select r If you are logged in as an operator use and Y to highlight Maintenance and press Select Venaxis Inc Page 52 APPYReader User Manual 13 03 07 02 04 pm Maintenance Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout Supervisor Settings Screen Operator Maintenance Screen 3 If you are logged in as a supervisor use a and v to highlight Device Info and press Select If you are logged in as an operator use amp and v to highlight Settings and press Select 137 03 07 02 00 pm fth 01 13 10 06 31 pm Device Info Settings str vrstn Supervisor History Global Settings Global Settings Supervisor History Supervisor Device Info Screen Operator Settings Screen 4 Use a and v to highlight Global Settings and press Select to display the Global Settings screen The reader s current settings are displayed You can scroll through s
25. and press Select Venaxis Inc Page 37 APPYReader User Manual 12 12 05 05 12 pm Maintenance Settings Check AppyReader Change to Supervisor Maintenance Screen 3 Use a and v to highlight Check APPYReader and press Select A 12 12 06 01 00 pm Check AppyReader Control 1 Contral 2 JC Cassette Check APPYReader Screen 12 06 05 03 08 pm Insert Cassette Place a test cassette In the cassette drawer Apply the test sample Close the drawer lain Menu Insert Cassette Screen Liguid 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 Venaxis Inc Page 38 APPYReader User Manual 7 Gently close the drawer The test will start automatically 13 03 18 06 38 pm Run Test Patient Liguid OC 1 Remaining Time m s 01 15 Reading Processing 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 A 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 Sj ug mL to ug mL MR
26. 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 MA 12 12 05 05 Of pm Enter Patient ID Enter a patient ID using the barcode scanner or using the keypad 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 1 BC DEF GH Ss 3 KL MN O PWR SE OV MAY 2 j Clear all Use SW and P to highlight the desired character Press Confirm amp Next to add the highlighted character to the user name Repeat Step a and Step b as necessary When the name is complete use a Vv ana Wto highlight Done Select Confirm amp Next Page 11 APPYReader User Manual 2 5 Understanding Labeling Symbols The following symbols are located on the bottom of the reader Venaxis Inc This symbol Uu Consult Instructions for Use Humidity Limitation Nan Temperature Limitation Federal Communication Commission U S Authorized Representative in the European Community The device reguires safe disposal in conformance with the WEEE Directive 2012 19 EU EG The polarity of the power supply tip is positive Class 1M UV LED Product Do not view directly with optical instruments Page 12 APPYReader User Manual 2 6 Safety Symbols The following symbols are used in this User Manual 2
27. 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 IMPORTANT You must add the first supervisor user before you can NN change any reader settings In order to add the first supervisor user you need to obtain a one time PIN by calling Venaxis Customer Care at 1 877 276 1976 or 1 303 794 2000 IMPORTANT A one time PIN can be used only on the day when it is NN provided You should add the first supervisor user as soon as you obtain this PIN Venaxis Inc Page 18 APPYReader User Manual With the one time PIN perform the following steps to create the first supervisor user 1 Press to display the operator Main Menu screen fm 01 26 10 02 35 pm p Run Test Ay Result History ini Maintenance Operator Main Menu Screen 2 Select Maintenance 12 12 05 05 12 pm Maintenance Settings Check AppyReader Change to Supervisor Pai Wen Maintenance Screen 3 Select Change to Supervisor 12 12 05 05 14 pm Enter One Time PIN Supervisor mode required To change to Supervisor mode please enter a One Time PIN One Time PIN am Enter One Time PIN Screen 4 Use the numeric keypad to enter your one time PIN in the One Time PIN field Press Confirm Venaxis Inc
28. creen 5 If you want to print the supervisor history press Print 6 Press Back to return to the previous screen or press to return to the Main Menu screen 5 3 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 APOTime 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 Venaxis Inc Page 51 APPYReader User Manual 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 Langu
29. d QC performed on the reader When you have finished viewing result details press Back b To print the result highlight Print Result and press Select c To print all the test results stored in the reader highlight Print All and press Select d To send the result to a LIS system highlight Send Result and press Select e Tosend all the test results to a LIS system highlight Send All and press Select 4 5 2 Viewing a 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 ms 12 12 06 03 28 pm Result History Patient Results Liquid QC Results QC Cassette Results Read Cassette Sain Men 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 Venaxis Inc Page 46 APPYReader User Manual 2 Place the test cassette over the reader keypad 3 Use Sand W 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 APPY 1 Result NEGATIVE WBC Entered 12 4 Time 06 15PM 13 03 18 Read Result on Cassette Screen 4 Use and to review the result stored on the cassette 5 You can also press P
30. drawer 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 APP YReader QC Cassette Result Screen 7 QC cassette result options a Press Options APPYReader OC Cassette Line O 3699 Line 1 7264 Result Send All Print All APPYReader QC Cassette Options Screen b To print the result Use a and v to highlight Print Result and press Select Venaxis Inc Page 36 APPYReader User Manual C To print all the QC cassette results stored in the reader highlight Print All and press Select d To send the result to a LIS system highlight Send Result and press Select 12 09 19 02 47 pm Sending Result Establishing connection Cancel QC Cassette Result Sending to LIS Screen e To send all the QC cassette results to a LIS system highlight Send All and press Select IMPORTANT The QC cassette is REUSABLE and should NOT be discarded until the end of its useful life Avoid light exposure and NN reseal and store the QC cassette in its original pouch immediately after each use 4 3 2 Running Liquid Quality Control QC 7 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
31. e back of the reader then releasing it 2 Turn the reader over so that the back of the battery cover is visible 3 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 4 Remove the old batteries 5 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 Installing the Batteries Venaxis Inc Page 59 APPYReader User Manual 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 Page 60 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 Corrective Actions 1 Remove the printer cover to reveal the paper compartment 2 Remove and reinsert the paper roll so that the end of the paper comes from under the roll toward the reader display 3 Replac
32. e reader until the Patient ID is confirmed Venaxis Inc Page 42 APPYReader User Manual 11 Press Next and the following 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 Ifthe 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 am Result List I Date Time Result D 123123 13 03 13 01 20PM NEGATIY XKEWT 13 03 08 09 43AM NEGATIY B20xX 13 03 08 09 33AM Notestr UBKX 13 03 08 09 23AM NEGATIY 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 Venaxis Inc Page 43 APPYReader User Manual 13 Press to eject the drawer Remove the test cassette and dispose or store as appropriate 4 5 Managing
33. e 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 61 APPYReader User Manual 7 1 Understanding Error Messages Refer to the table below for instructions for responding to error messages Error Message Corrective Action Barcode Scan Failed Attempt to read the barcode again If the problem persists check the connection to the barcode scanner Battery Low Replace the readers 4 AA
34. eader 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 S 01 05 10 01 05 pm 13 03 07 12 54 pm Main Menu Main Menu Import Export Run Test a Settings ey Result History th Oper Administration ini Maintenance Tami Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 2 4 3 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 Touse asoft key selection press the soft key below the desired option 2 4 4 Selecting Menu Items 4 D Use navigation keys 4 and gt 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 Set Language O Deutsch O Frangais O Italiano O Nederlands Set Language Screen Venaxis Inc Page 10 APPYReader User Manual 2 4 5 Venaxis Inc Entering Text Text can be entered for patient IDs supervisor IDs operator IDs and guality control lot numbers Numbers
35. er Manual 4 Use A and Vv to highlight the result you want to delete and press Options Ato display the Delete Results Options menu aa A 13 03 14 OF 59 am Delete Results ID Date Time Result UBE 13 03 08 09 23AM NEGATI Result Inconcl Negative Results List Options Screen Delete Results 5 To delete only the selected result highlight Delete Result and press Select 6 To delete all test results highlight Delete All and press Select 7 To delete all inconclusive test results Delete Inconcl and press Select 8 To delete all negative test results highlight Delete Neg and press Select 9 After deleting the reader displays the Delete Results confirmation screen to inform you that the selected results have been deleted a tu fy 15 12 1282 05529 pm 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 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 changing the date and time updating languages availab
36. ettings using a and v 13 03 05 08 46 pm Global Settings Logout Time 99 min Power Off Time 99 min Auto Login Disabled Immediate Print Disabled Manual Entry Enabled Global Settings Screen 5 If 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 Page 53 APPYReader User Manual 5 4 Deleting Stored Test Results Supervisor users can delete test results stored in the readers 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 Go to the supervisor Settings screen 2 Use and W to highlight Delete Results and press Select or or amp EEE a Ll 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 and v Yr amp 13 03 14 07 58 am Delete Results ID Date Time Result ZWWD 13 03 08 09 13AM NEGATI 123123 01 01 01 12 00AM INCONC 4489 01 01 01 12 00AM INCONC Delete Results Screen Venaxis Inc Page 54 APPYReader Us
37. 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 66 APPYReader User Manual FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT 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 i
38. g NOTE N The language setting determines what language is displayed on the reader screen and printouts To change see Changing the Language 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 The print setting determines whether test results are printed automatically upon completion of a patient test To change see Changing the Print Setting 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 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 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 Only supervisor users can change reader settings If you are logged in as an operator select Maintenance gt Change to Supervisor to change settings 3 6 Changing Settings Supervisor users can change the reader s settings Settings are changed from the Settings screen Venaxis Inc Page 22 APPYReader User Manual Perform the following steps to get to the Settings screen 1 Press to display the supervisor Main Menu screen 13 03 07
39. ge of the reader 15 C to 30 C 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 cassette Page 63 APPYReader User Manual 8 System Specifications Product Information APPYReader Part Number F10009 Dimensions 24cm deep x 17cm wide x 12cm high Weight 3 lbs Power Requirements AC Operation 6 VDC at 4 16 A 4 AA LR6 Cells Battery Operation Nominal Voltage gt 1 5 VDC ng Environment Altitude 0 to 2000m Temperature 15 C to 30 C Humidity 30 to 80 non condensing Storage Environment 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 NN authorization instructions Venaxis Inc Page 64 APPYReader User Manual 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
40. le 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 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 Venaxis Inc Page 56 APPYReader User Manual 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 3 If necessary tear or cut the end of the new paper roll to form a straight edge Insert
41. nect the optional barcode scanner accessory to the reader Used to connect the reader to the LIS network Used to connect the AC power adapter to the reader Used for importing and exporting information via the SD card Used to turn the reader on and off Page 8 APPYReader User Manual 2 4 Understanding Screens and Menus Each screen is divided into three areas the header bar the content area and the soft keys Run Test Er Result History ini 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 or an operator The 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 The date and time are shown to the right of the user information The icon shown at the far right indicates whether the reader is using AC or battery power This Icon indicates that The user is logged 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 Page 9 APPYR
42. ng 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 to delete the last character entered Venaxis Inc Page 33 APPYReader User Manual 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 a7 Barcode PIN Supervisor Operator Login Screen 2 Press W to highlight the PIN field 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 e Communication between the different reader modules is working e Reader settings and calibration integrity are verified e The optics are functioning properly e The carriage is free to move co
43. nnect the other end of the Ethernet cable to the LIS network 3 Goto the Settings screen 4 Use amp D and to highlight Network Setup and press Select to isian the Network Setup screen 01 07 10 03 27 pm Network NETBIOS name Show Network Settings Network Setup Screen 5 Use and P to highlight Network Configuration and press Select 13 03 14 07 35 am Network Configuration O Manual Back Network Configuration Screen 6 The following options are available on the Network Configuration screen To obtain the readers IP address port ideas subnet mask and standard gateway automatically using DHCP use and Y wo highlight DHCP Then press Select The reader obtains the network information and displays the Network Setup screen To enter the readers ka port number subnet mask and standard gateway manually use MW and v 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 Y to highlight the Port number field Venaxis Inc Page 30 APPYReader User Manual NOTE To delete the last character entered press G b Use the numeric keypad to enter the port number for the reader Then press W to highlight the Subnet Mask field c Use the numeric keypad to enter the subnet mask for the reader Then press Y to highlight the Standard Gateway
44. nter Temperature High RFID Error SD Card Read Error SD Card Write Error Temperature Error Too Many Users Selected Used Cassette Venaxis Inc 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 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 Make sure 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 ran
45. onents The following components are included in the APPYReader Kit Reader QC Cassette Universal Power Transformer Thermal Paper Rolls 2 Power Cord User Manual CD Warranty Card Plug Adapter Start Up Guide AA Batteries 4 NOTE To order consumables accessories or replacement parts for your reader contact your local distributor or Venaxis Technical Support Venaxis Inc 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 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 battery compartment Used to insert prepared test and QC cassettes in the reader Page 7 APPYReader User Manual 2 3 Reader Rear View 1 PS 2 Port 2 Ethernet Port 3 AC Power Port 4 SD Card Slot 5 On Off Switch Venaxis Inc Reader Back View Used to con
46. 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 Venaxis Inc Page 15 APPYReader User Manual mr A 13 03 07 12 56 pm Set Date Date format YYYY MM DD Year 2013 P Month 03 Ww a Day 07 Set Date Screen A IMPORTANT Allow the reader to warm up for at least 10 minutes before running any patient samples 3 4 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 a Settings Gh Oper Administration IS Change to Operator Supervisor Main Menu Screen NN IMPORTANT You must add the first supervisor user before you can 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 Venaxis Inc Page 16 APPYReader User Manual 3 Use S and W to highlight Settings and press Select Settings Select Language Read Temperature LIS Reviewer Setup Set Login Logout ain Men Supervisor Settings Screen 4 Use and W to highlight Set Date and Time and press Select Set Date
47. recent result automatically overwrites the oldest result WARNING When using the reader observe universal safety and laboratory precautions and 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 3 1 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 A IMPORTANT Use of any other 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 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
48. rint to print the result 4 6 Shutdown To turn off the reader push the on off switch until the screen menu disappears then release it Venaxis Inc Page 47 APPYReader User Manual 5 Review Reader Information Y NOTE Supervisors and operators can review information about the reader Some information is only available to supervisor users All 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 All users can review a listing of actions that have been performed by supervisors See Reviewing the Supervisor History for instructions 5 1 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 mr A 13 03 07 12 54 pm fh Main Menu Main Menu m3 Settings Cw Result History Gh Oper Administration ini Maintenance I8 Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen Pos 2 If you are logged in as a supervisor use and to highlight Settings and press Select If you are logged in as an operator use A and Vto highlight Maintenance and press Select Venaxis
49. rrectly e The carriage position is zeroed 4 IMPORTANT On each day of testing the reader should be powered on and allowed to complete its initialization and self checks Venaxis Inc Page 34 APPYReader User Manual 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 A 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 supervisor 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 12 12 05 05 12 pm Maintenance Settings Check AppyReader Change to Supervisor Maintenance Screen 3 Use and V to highlight Check Reader and press Select fa 12 12 0 6 0100 pm Check AppyReader Control 1 Control 2 JC Cassette Select Check APPYReader Screen 4 Use Sand Y to highlight AC Cassette and press Select Venaxis Inc Page 35 APPYReader User Manual 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
50. s 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 or an experienced radio TV technician for help CAUTION Any changes or modifications not expressly approved by the grantee of this device could void the user s authority to operate the equipment Venaxis APPY1 and APPYReader are trademarks of Venaxis Inc L10019EN 03 Venaxis Inc Page 67
51. sults and press Select The reader displays the patient ID date time and test result for results in the readers memory starting with the most recent test Scroll through results using aa and v yay 13 Result List ID Date Time Result 123123 13 03 13 01 20PM NEGATIY KEWT 13 03 08 09 43AM NEGATIY 037 19 09 37 am B2Z0 13 03 08 09 33AM Notestr UBER 13 03 08 09 23AM NEGATIY Result List Screen Use A and v to highlight the desired result and press Options A to display the Result List Options screen 13 03 19 09 38 am Result List Options ID Date Time Result 123123 13 03 13 01 20PM NEGATIY Show Details Print All Result List Options Screen Send All a To see the result details highlight Show Details and press Select 13 03 18 06 16 pm Result Details Patient ID 123123 Assay APPY1 Result NEGATIVE WBC Entered 12 4 Time 06 15PM 13 03 18 Result List Detailed Result Screen Page 45 APPYReader User Manual 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 APPY1 Result The result of the APPYI 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 liqui
52. tory Gh Oper Administration mi Maintenance IS Change to Operator Supervisor Main Menu Screen Operator Main Menu Screen 2 If you are logged in as a supervisor use a and v to highlight Settings and press Select If you are logged in as an operator use a and v to highlight Maintenance and press Select 01 07 10 03 26 pm A 13 03 07 02 04 pm Settings Maintenance etbateanttine Select Language Check APPYReader Read Temperature Change to Supervisor LIS Reviewer Setup Set Login Logout Main Won Sain on Supervisor Settings Screen Operator Maintenance Screen 3 If you are logged in as a supervisor use a and v to highlight Device Info and press Select If you are logged in as an operator use a and v to highlight Settings and press Select Venaxis Inc Page 50 APPYReader User Manual 90 07 02 00pm fh 01 13 10 06 31 pm ANT Supervisor History Global Settings Global Settings Supervisor History Supervisor Device Info Screen Operator Settings Screen 4 Use Sand W 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 Se and Vv B fm 01 15 10 00 22 am Supervisor History ID Date Time Action Date Time Action 0011 06 04 08 09 22AM 10 Cc 0010 06 03 08 09 21AM 0009 06 02 08 O9 204AM 08 0008 06 01 08 09 194M OF naat Supervisor History S
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