InstructionsforUse PixoTestPointofCareTest
(POCT)System Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 2of26 TheInstructionforUseofPixoTestPOCTSystemonPixoTestA1c&Lipidteststrip............1 1. Indicationforuse................................................................................................................4 2. Testprinciple.......................................................................................................................4 3. Beforetest..........................................................................................................................4 4. ThePixoTestPOCTSystemincludes................................................................................5 5. Teststrip.............................................................................................................................5 6. Settings...............................................................................................................................6 7. Preparingformeasurement...............................................................................................6 8. RunningtestA1c.................................................................................................................7 9. Runningtestlipid................................................................................................................9 10. Understandingresult..........................................................................................................9 11. Record...............................................................................................................................10 12. Calibration.........................................................................................................................11 13. Controlsolutiontest.........................................................................................................11 14. CStestforA1c...................................................................................................................12 15. CStestforLipid.................................................................................................................13 16. ControlSolutionrangeandmeaning................................................................................13 17. Shutdownprocedure........................................................................................................13 18. Maintenanceandtroubleshooting...................................................................................14 19. Cleananddisinfection......................................................................................................14 20. ErrorandWarningmessage.............................................................................................18 21. Disposalinformation.........................................................................................................20 22. Productinformation.........................................................................................................20 23. Limitation..........................................................................................................................22 24. Manufacturer....................................................................................................................22 25. Symbol..............................................................................................................................22 26. Servicing............................................................................................................................23 27. LimitedWarranty..............................................................................................................23 Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 3of26 Appendix1:Reference..24 1. Indicationforuse TheiXensorPixoTestPOCTSystemiscomprisedofPixoTestA1c/LipidTestStrip,PixoTestPOCT Analyzer,PixoTestPOCTCalibrationCard,andthePixoHealthPOCTA1c/LipidAPPasthedisplay componentofthesystem.TheiXensorPixoTestPOCTSystemisintendedtobeusedforthequantitative measurementofHbA1candLipids(includingTotalciholesterol,Triglycerides,andHighDensityLipoprotein
(HDL)cholesterol)inwholebloodfrombothcapillaryandvenous.EstimatedvaluesforLowDensity Lipoprotein(LDL)cholesterolarecalculatedbythePoxoHealthPOCTLipidAPP. ThePixoTestPOCTSystemisaprofessionaluseonlyproductandintendedforinvitrodiagnosticuseandis notintendedforuseonneonates. Untrainedpersonnelcouldperformitwell 2. Testprinciple TheiXensorPixoTestPOCTSystemcombinesenzymaticmethodologyandreflectancephotometryto measureHbA1candLipids.Samplesfrombothcapillaryandvenouswholebloodcanbeused.Thiswhole bloodsampleisappliedtoPixoTestA1c/LipidTestStrip,andareactionoccurstoproduceacolorthatis readbyusingreflectancephotometryofthereagentarea.Thelevelofcolorproducedisproportionaltothe concentration. PixoTestPOCTSystemA1cusesanantiHbA1c(%)antibodywhichisspecificforthefirstfewaminoacid residuesoftheglycatedNterminusofthechainofhemoglobinA0.PixoTestA1cTestKitcontainsthe PixoTestA1cTestStrip(nitrocellulosemembrane),Spoitwithlatextablet(bluedyedlatexmicroparticles conjugatedtospecificantibodies)andBuffersolutiontube(hemolysisreagent).Whenwholebloodisadded tothebuffersolutionandismixedwiththelatextablet,theerythrocytesareinstantlylysedtoreleasethe glycatedhemoglobin(hereafter,HbA1c).Whenthesamplemixtureisloadedontothesampleportofthe testpanel,themixturefluidmigratesalongthemembraneofthetestpanelbycapillaryaction,andthe HbA1cisthenimmobilizedontotheantiHbA1cantibodycoatedline.Theamountoftheblueconjugateson theantiHbA1clinereflectstheamountofHbA1cinthesample,theintensityofhemoglobincolor measuredfromthedesiredareaonthemembraneoftestpanelismeasured.Chemicalandimmune reactionthatoccursontheteststripismeasuredbytheopticalsysteminPixoTestPOCTSystem.This systemmeasuresbothfractionsandanalgorithmwhichconvertstheresultintothepercentageHbA1cin thesample. PixoTestPOCTSystemLipidscombinesenzymaticmethodologyandreflectancephotometrytomeasure Totalcholesterol,Triglycerides,andHDLcholesterol.WhenwholebloodsampleisappliedtoPixoTestLipid TestStrip,thebloodreactstoproducecolorthatisreadbyusingreflectancephotometryofthereagent area.Thelevelofcolorproducedisproportionaltotheconcentration.Alllipidenzymaticreactionscanrefer toLipidteststripinsert. BeforeusingthisproducttotestyourA1candLipids,carefullyreadthisInstructionforUse.Priorto launchingthePixoHealthPOCTA1c/LipidsApp,usethePixoTestPOCTCalibrationCardtoverifythatthe PixoTestPOCTSystemisworkingproperly.TheA1c/LipidsControlSolutionisusedtoverifythatthe PixoTestPOCTSystemandPixoTestA1c/LipidTestStripareworkingproperly. 3. Beforetest NOTE Thebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem. DonotchargeyourPixoTestPOCTSystemwhenitisinuse. Ifthebatteryisbelow20%orcharging,anerrorwillappearandthetestcannotbestarted. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 4of26 4. ThePixoTestPOCTSystemincludes ThePixoTestPOCTAnalyzer:
*PixoHealthPOCTA1c/LipidApp
*USBCharger
*IndicationsForUse Fig.1FrontsightofPixoTestPOCTAnalyzer(POCX01)
* USBTypeCChargeCable
*TestStripInsert
* PixoTestPOCTCalibrationCard Display Showsatestresult,messages,andthetestresults storedinmemory. SlidingDoor Opentoapplysample. ItemSelectionKey Selectmeasurementmode. PowerKey PresstoturnanalyzerONorOFF. USBChargePort Chargetheanalyzer. ProtectionCover Removetoclean. LipidTestStripSlot Insertalipidteststriphere. A1cTestStripSlot InsertA1cteststriphere. StripModule StripModuleLockSwitch Unlocktochangethestripmodule. CameraModule ScanQRcode A B C D E F G H I J K Fig.2BacksightofPixoTestPOCTAnalyzer(POCX01) 5. Teststrip PixoTestPOCTSystemincludesPixoTestPOCTA1cTestkitandPixoTestPOCTLipidTestStrip(bothsold separately).Thefollowingcontentsareincluded:
PixoTestPOCTA1cTestkit(usewithPixoTestPOCTAnalyzer):
20PixoTestA1cTestStrips(fordifferentpackage) 20Spoitwithlatextablet 20Buffersolutiontube 1packageinsert Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 5of26 PixoTestPOCTLipidTestStrip(usewithPixoTestPOCTAnalyzer):
25PixoTestLipidTestStrips(fordifferentpackage) 1packageinsert 6. Settings WhenusingthePixoTestPOCTSystemforthefirsttime,performthefollowingsteps:
Step1.PressthePowerKeyfor2secondstoturnontheAnalyzer. Step2.SlideupthescreentounlocktheAnalyzer. Step3.SelectLanguageoption.Theselectedlanguageisshownonthe2ndlineitem. Step4.TurnontheWificonnection,typinginthepasswordifnecessary.Connectionstatusisshownatthe Step5.ClickVersionChecktoverifythatthemostuptodateAPPversionisinstalledorneedstobe 2ndlineitem. updated. Step6.SelectTimeZoneoptiontosetthe24hourFormat,andmanuallyselectthecorrecttimezone. Step7.PressNextontheSystemActivationscreentoscantheproductkeywhichisprovidedbythelocal distributorortheservicecentertoactivatetheanalyzer.Onceitisactivated,pressFinishbuttonto completeallsettings. OnHomescreen,themainscreenofthePixoTestPOCTsystem,presstheSettingsbuttonforthechange ofthesystemsettings,includesLanguage,WifiandTimeZone. NOTE Aftercompletingallsettings,acalibrationisrequiredbeforeoperating,andmustbedonedaily.Referto Chapter13forthecalibrationprocess. 7. Preparingformeasurement TheiXensorPixoTestPOCTSystem PixoTestA1c/LipidTestStrip PixoTestPOCTAnalyzer:POCX01 PixoHealthPOCTA1c/LipidAPP PixoTestPOCTCalibrationCard A1c/LipidControlSolution SpoitwithlatextabletandBuffersolutiontubeforA1ctest 35ltubeforLipidtest*
Additionalrequiredmaterials:
Alcoholswabstocleanpuncturesite TheEPAregistereddisinfectantwipestodisinfectthesurfaceofPOCTsystem Lancetsforcapillaryorvenousbloodcollectionsupplies(vacuumcollectiontubes,needlesandtube Instructionsforuse holders) Gloves Biohazardwastecontainers NOTE
*:35ltubearenotincludedandcanbepurchasedfromalocaldistributor;collectsamplewithasuitable toolfor35L(ex:micropipetteorquantitativedropper.) Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 6of26 POCX01 PixoTestPOCTSystemisintendedtomonitorA1candLipidsusingPOCX01(Fig.1)toconductthetest. Itemselectionkey:TotestA1C,slidetheItemSelectionkeytotheIIindication.TotestLipids,slidethe itemselectionkeytotheIindication. Slidingdoor:WhentestingLipids,opentheslidingdoortoinsertthePixoTestlipidteststripintotheLipid TestStripSlot. A1cTestStripSlot:ToinsertthePixoTestA1cteststripintotheA1cteststripslot(Fig.2). LipidTestStripSlot:ToinsertthePixoTestlipidteststripintothelipidteststripslot(Fig.2) CAUTION KeepPixoTestLipidTestStripstoredinadryplacebetween3690F(232C),andavoiddirectsun exposure. KeepA1cTestStripstoredinadryplacebetween3486F(130C),andavoiddirectsunexposure. DoNotopentheteststrippackageuntilreadytoperformthetest.Useteststripimmediatelyafter removalfromthepackage. DoNotreturntheusedteststriptotheoriginalboxafterperformingthetest;disposeofusedteststrip. DoNotreuseateststripthathadbloodorcontrolsolutionappliedtoit.Thestripisforsingleuseonly. DoNotmodifytheteststripinanyway. DoNotuseyourPixoTestA1c/LipidTestStripifthepackageisdamagedorleftopentoair. DoNotusethedevicenearsourcesofelectromagneticradiationsuchasmicrowaves. DoNotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriate lightenvironment. DoNotuseteststripaftertheexpirationdate(printedonthepackage)oryourresultsmaybe inaccurate. AlwayskeepPOCX01clean. Confirmthatthecodenumberisthesameasthecodeonthefoilpouchpackage. Toconservepower,theAnalyzerturnsitselfoffafter10minutesunlessapowerbuttonispressed.When theAnalyzerturnsitselfoff,alltestresultsobtainedsofarremaininthememory. Whenthelowbatterywarning(lessthan20%)appears,atestcannotbeperformed.ChargetheAnalyzer immediately. Measurementresults,includingtherelatedmeasurementdateandtimeaswellasallotherAnalyzer settings,remainstoredevenwhenthereisnopower. 8. RunningtestA1c Step1.Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely. Step2.TapSettingsbuttonontheHomescreenofPixoTestPOCTSystemandtapA1cbuttontoopen thePixoHealthPOCTA1cApp. Step3.TapRenewtoscantheQRcode,pastedontheteststripbox. Step4.TapNextbuttontostartA1cmeasurement. Step5.PleaseslidetheitemselectionkeytotheIIindication.Checkthestripcodenumberandinsertthe teststripintheslot.Pressinitializebuttonforinitialization. NOTE 1. PleasemakesurethePOCX01isplacedonaflatsurface. 2. Thesystemshowsthenumberoftheremainingtest.PleaseopenanewstripboxandscanitsQRcode toresetthecountingwhentheremainingtestsreacheszero. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 7of26 Step6.Obtainabloodsampleusingthelancetandlancingdevice.(Ifyouusethevenousblood,checkthe collectiondateandtheanticoagulant.) Step7.Collectthe5lbloodsampleandputitinthebuffersolutiontube. Step8.Mixthebuffersolutionandbloodsamplebygentlysqueezingtherubbertopofthespot68times. NOTE 1.Blocktheholeonthestopofthespotwhilemixing. 2.Avoidbubbleswhilemixing. 1 2 Step9.Collectallthereactionmixturefromthebuffersolutiontube.OncetheApplyBloodanimationon thescreen,thebloodsamplecanbeappliedontheteststrip.TheA1ctestresultwillappearafter3 minutes. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 8of26 9. Runningtestlipid Step1.Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely. Step2.TapSettingsbuttononHomescreenofPixoTestPOCTSystemandtapLipidbuttontoopenthe PixoHealthPOCTLipidApp. Step3.TapRenewtoscantheQRcodepastedontheteststripbox. Step4.TapNextbuttontostartthelipidmeasurement. Step5.PleaseslidetheitemselectionkeytotheIindication.Checkthestripcodenumberandinsertthe teststripintheslot.Pressinitializebuttonforinitialization. Step6.Obtainadropofbloodsampleusingthelancetandlancingdevice. Step7.Collecta35lbloodsampleusingthetube.Placethebloodsampleintotheapplicationholeofthe teststrip.Then,closetheslidingdoor. Step8.Lipidtestresultwillappearafter3minutes. NOTE Thesystemshowsthenumberoftheremainingtest.PleaseopenanewstripboxandscanitsQRcodeto resetthecountingwhentheremainingtestsreacheszero. 10. Understandingresult MeasuringRange Teststripscanmeasurenumericalresultsinthefollowingranges:
HbA1c:415%(68.1383.8mg/dL,3.7721.26mmol/L) TotalCholesterol:100450mg/dL(2.5911.64mmol/L) Triglycerides:45650mg/dL(0.517.34mmol/L) HDLcholesterol:2595mg/dL(0.652.46mmol/L) LDLcalculatedrange:66225mg/dL(1.71~5.82mmol/L) Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 9of26 Iftheresultisoutsidethemeasuringrange,thesystemwilldisplayHiwhentheresultsareabovethe measuringrange,anddisplayLowhentheresultsarebelowthemeasuringrange. CAUTION IfthereisaLo/Hioranunexpectedresultforanytest,testagainwithanewteststrip. 11. Record ReviewingPastResults OpenupthePixoHealthPOCTA1c/LipidApp.Threefunctionbuttonswillappearonthescreen.Tapthe Recordsicontorevieweachpastresultbydateandtime. A1cRecords LipidRecords ExpectedValues A1c:
%HbA1c
<=5.6%
5.6%6.5%
>=6.5%
Interpretationofresults NonDiabeticRange ADA(AmericanDiabetesAssociation)Target AboveTarget Displaycolor Green Yellow Red Lipid:
ThenationalHeart,LungandBloodInstituteissuedtheThirdReportofNationalCholesterolEducation Program(NCEP)ExpertPanelonDetection,Evaluation,andTreatmentofHighBloodCholesterolinAdults
(AdultTreatmentPanelIII)inMay2001.TheATPIIIreportpresentedtheNCEPsupdatedclinicalguidelines forcholesteroltestingandmanagementanddescribedthefollowingclassificationsforcholesteroland triglyceridetesting. TC(TotalCholesterol) TG(Triglycerides) HDL LDL mg/dL
<200 200239
>=240
<150 150199
>=200
<40
>=60
<100 100129 mmol/L
<5.18 5.186.19
>=6.22
<1.69 1.692.25
>=2.26
<1.03
>=1.55
<2.59 2.593.34 130159 160189
>=190 3.364.11 4.144.89
>=4.91 Classification Desirable Borderlinehigh High Normal Borderlinehigh High Low High Optimal Nearoptimal/
aboveoptimal Borderlinehigh High Veryhigh Displaycolor Green Yellow Red Green Yellow Red Black Black Black Black Black Black Black Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 10of26 TheATPIIIidentifiedHDLlevelsbelow40mg/dL(1.03mmol/L)asassociatedwithincreasedriskofcoronary heartdisease(CHD)inmenandwomen.AhighHDLlevelgreaterthanorequalto60mg/dL(1.55mmol/L) isprotectiveanddecreasesCHDrisk. 12. Calibration LDL LDLcanbecalculatedusingtheequationbelow.CalculatedLDLisanestimationofLDL,definedbythe specificationofTC,TG,andHDL. LDL(calculated)=TotalCholesterolHDL(Triglyceride/5)(mg/dL) LDL(calculated)=TotalCholesterolHDL(Triglyceride/2.17)(mmol/L) ThePixotTestPOCTsystemwillautomaticallyalerttheUsertocompleteacalibration.Theusermustto completethecalibrationwithPixoTestPOCTCalibrationCard. PixoTestPOCTCalibrationCardisusedtocalibratethePixoTestPOCTsystemandtoconfirmthefunction ofthefrontcameraandPixoHealthPOCTA1c/LipidApp. ThePixoTestPOCTSystemmustbecalibrateddaily.Ifthishasnotbeencompleted,thePixoHealthPOCT A1c/LipidAppwillnotbeabletoperformtestsuntilcalibrationhascompleted. WhentodoaCalibration:
WhenusinganewboxofA1c/LipidTestStrip. Whenthereisanunexpectedtestresult. WheretoperformaCalibration:
ThesystemshowsCALIBRATIONontheHomescreenautomaticallyatthefirsttimeusingtheAnalyzer everyday.TaptheCalibrationbuttontostartthecalibrationprocess. Toperformacalibrationanytime,tapSettingsbuttononHomescreenofPixoTestPOCTsystemand tapCalibrationbuttontostartthecalibrationprocess. AcalibrationtestcanbeinitializedfromtheSettingsofPixoHealthPOCTA1c/LipidAppanytime. HowtoCalibrate:
Step1:PleaseslidetheitemselectionkeytotheIIindication.InserttheCalibrationcardintotheA1cslot andpressCalibratebutton. Step2:TheAPPwillautomaticallystartthecalibration.Waitforafewsecondstocompletethecalibration. Step3:Whenthecalibrationiscomplete,tapConfirmtocontinuethetestingmode. NOTE 1.Avoidlongexposurestolight. 2.Avoidtouchingfinishedsurfaceoncolorblockofcalibrationcard. 3.Keepcalibrationcardinblackprotectivesheathwhencompletedcalibration. 13. Controlsolutiontest iXensorCo.Ltd.doesnotprovidecontrolsolutions,BioRadcontrolsolutionofA1candLipidare Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 11of26 recommendedforPixoTestPOCTSystem:
A1c:BioRadLiquicheckDiabetesControl(level1,2),Cat#171,172 Lipid:BioRadLiquicheckLipidsControl(level1,2),Cat#641,642 TheControlSolutionisusedtoverifythatthePixoTestPOCTSystemisworkingproperly(A1c/LipidControl Solutionaresoldseparately).Topurchasethecontrolsolution,pleasecontactiXensorCo.Ltd.tollfreeat1 8002180929,MonFri9AM5PM(PST). WhentodoaA1c/LipidControlSolutionTest CAUTION UseonlytheBioRadA1c/LipidcontrolsolutiontoverifythatthePixoTestPOCTSystemisworking Ifthestrip,PixoHealthPOCTA1c/LipidApporPOCTX01seemstonotbeworkingproperly. Ifthetestingresultsareunusualorunexpected. IftheAnalyzerhasbeendroppedordamaged. properly.Donotuseanyotherbrandofcontrolsolution. A1c/LipidControlSolutionisforinvitrodiagnosticuseonly.Thismeansthatisonlyusedfortesting outsideofthebody. DoNotswalloworingestA1c/Lipidcontrolsolution. DoNotuseA1c/Lipidcontrolsolutionaftertheexpirationdate(printedoncontrolsolutionbottle,shelf life:3yearat20 to70)orthediscarddate(14daysfromthedatethecontrolsolutionvialwas opened),whichevercomesfirst.Usingthesolutionaftertheexpirationordiscarddatewillcauseyour resultstobeinaccurate. Step1:Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely. Step2:CleananddisinfecttheAnalyzersurfaceasinstructed.Startacontrolsolutiontestbytappingtheicon SettingsandselectControlSolutionTestoptioninthePixoHealthPOCTA1cApp. Step3:ThemainscreenofControlSolutionTestlistsalltestresults,taptheStarttestingbuttontoenter Step4:TapRenewtoscanthecodeontheteststripboxifthecodehasntbeenscanned.AndpressNext theTestInfoscreen. buttontostartthetest. Step5:PleaseslidetheitemselectionkeytotheIIindication.Checkthestripcodenumberandinsertthe teststripintheslot.Pressinitializebuttonforinitialization. Step6:Oncethecontrolsolutionapplyinganimationisdisplayedonthescreen,obtainacontrolsolution sampleofLevel1orLevel2andapplythecontrolsolutionontheteststrip.Thetestresultwillappear after3minutes. NOTE 1. PleasemakesuretheAnalyzerisplacedonaflatsurface. 2. Thesystemshowsthenumberofremainingtests.PleaseopenanewstripboxandscanitsQRcodeto resetthecountingwhentheremainingtestsreacheszero. 14. CStestforA1c Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 12of26 15. CStestforLipid Step1:Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely. Step2:CleananddisinfecttheAnalyzersurfaceasinstructed.Startacontrolsolutiontestbytappingthe iconSettingsandselectControlSolutionTestinthePixoHealthPOCTLipidApp. Step3:ThemainscreenofControlSolutionTestlistsalltestresults,taptheStarttestingbuttontoenter Step4:TapRenewtoscanthecodeontheteststripboxifthecodehasntbeenscanned.Andpress theTestInfoscreen. Nextbuttontostartthetest. Step5:PleaseslidetheitemselectionkeytotheIindication.Checkthestripcodenumberandinsertthe teststripintheslot.Pressinitializebuttonforinitialization. Step6:Obtainacontrolsolutionsampleusingthe35ltube. Step7:Collectthe35lcontrolsolutionusingthetubeandplacethecontrolsolutionsampletothe applicationholeoftheteststrip,thenclosetheslidingdoor. Step8:Lipidcontrolsolutiontestresultwillappearafter3minutes. NOTE 1. Thesystemshowsthenumberoftheremainingtests.PleaseopenanewstripboxandscanitsQRcode toresetthecountingwhentheremainingtestsreacheszero. 2. Removeanddiscardtheusedteststrip.Donotaddmorebloodtoausedteststrip. 16. ControlSolutionrangeandmeaning OutofRangeResults Aftercontrolsolutiontest,checktheresultofthecontrolsolutionvalueandconfirmitiswithinrange.If testresultsfalloutsideoftheexpectedrange,pleaserepeatthetest.DonotcontinuewithyourA1c/Lipid testifthecontrolsolutiontestresultsarecontinuouslyoutofrange.Resultsthatfalloutsideofthe expectedrangemayindicate:
Testisnotperformedatroomtemperature. Controlsolutionhasexpired,isbeyonditsdiscarddate,orcontaminated. AtechnicalproblemwithyourPixoTestPOCTSystem. Controlsolutionthatistoowarmortoocold. AproblemwiththeTestStrip(expiredordamaged). Anerrorcallsduringthetest. 17. Shutdownprocedure WhenfinishusingthePixoTestPOCTSystem,followthestepstoturntheAnalyzeroff:
Step1.PressthePowerKeyfor2seconds. Step2.TapPowerofftoturnofftheAnalyzer. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 13of26 18. Maintenanceandtroubleshooting CaringforthePixoTestPOCTSystemiseasy.Simplykeepitfreeofdust.Ifthesystemneedscleaning,follow theseguidelinescarefullytoobtainthebestperformance.TopreventmalfunctionoftheAnalyzer,keepthe teststripslotfreeofblood,dirt,ordust.UsealintfreeclothdampenedwithwatertocleantheAnalyzer. Ensuretheclothisdamp,andnotwet.Donotuseanabrasiveclothorantisepticsolution,asthesemay damagethedisplayscreen. Acleanopticalmeasuringsystemisabasicprerequisitefordeterminingprecisemeasuredvalues.Therefore, cleantheAnalyzerregularlyandimmediatelyafteritbecomesdirty.AlwaysswitchofftheAnalyzerbefore cleaningit. Useonlythefollowingitemsforcleaning:
Ordinarylintfreecottonbuds Ordinarylintfreetissues Ordinarydisinfectingtissues Donotuseanydisinfectantspraysortissuesorcottonbudswhicharedrippingwetastheliquidmay entertheAnalyzeranddamageit. CleaningtheouterAnalyzercomponents 1. WipetheoutsideoftheAnalyzerwithalightlymoistened,lintfreecottoncloth. 2. Removetheprotectioncover. 3. Incaseofsignificantdirt,youcanrinsetheprotectioncover(separatelyfromtheAnalyzer)underwarm runningwater. 4. Drythemeasurementchambercoverwithafreshcloth. Cleaningtheopticalmeasuringsystem 1. Removethestripmodule. 2. Cleantheeasilyaccessibleareasoftheopticalmeasuringsystemwithalintfreepadoramoistened cottonswab.MakesurethatnoliquidenterstheAnalyzer. 3. AllowtheAnalyzertodrythoroughly. 4. DonotfitthestripmoduleintotheAnalyzeruntilitiscompletelydry. 5. FitthestripmoduleintoAnalyzer. 6. TheAnalyzerisnowreadyforoperationagain Maintenance,TestingandTransportationAnalyzer 1. Keeptheteststripslotsfreeofdust. 2. ProtecttheinternalAnalyzerfromhumidity. 3. Therearenoeffectsonproductqualityinenvironmentaltemperaturesof2050C(4122F) during8hoursandhumidityofupto93%RH,noncondensingduring8hours. 19. Cleananddisinfection Duetotheriskofspreadingbloodborninfections,cleananddisinfectthePOCX01aftereverybloodtest. CleanthePOCX01toremovevisibledirt,bloodorothermaterialspriortodisinfecting.Followwitha secondwipetodisinfectthemeasurementmodule. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 14of26 Cleananddisinfectthemeasurementmoduleatleastonceperweekandwhenbloodispresentonthe surfaceofthePOCX01. FordisinfectingyourPOCX01,onlyuseCloroxHealthcareBleachGermicidalWipes(EPA*reg.no. 6761912),containingSodiumHypochlorite0.55%.[CanbepurchasedfromAmazon.com, Officedepot.comandWalmart.com]. Donotuseanyothercleaningordisinfectingsolutions. UseofdisinfectingproductsotherthanCloroxHealthcareBleachGermicidalWipeshavenotbeen validatedforthePixoTestPOCTSystemhavenotbeenvalidated.AlwaysuseCloroxHealthcareBleach GermicidalWipes. TestprocessLipid Usetwowipes. Followthecleaninginstructionforthefirstwipeandthedisinfectioninstructionforthesecond. Cleaning:
1. Followthecleaninginstructionfirst. 2. Putoncleangloves 3. Takeonewipeandsqueezeoutexcessmoisturefromthewipebeforeuse. 4. FollowtheFigure3towipethemeterfrontandmeterscreenrespectively. Figure3.Wipethemeterfrontandmeterscreenrespectively. 5. FollowtheFigure4towipethemeterback. Figure4.Wipethemeterback 6. FollowtheFigure5towipetheinsertionareaofstrip. Figure5.Wipetheinsertionareaofstrip Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 15of26 7. FollowtheFigure6towipetheitemselectionkey. Figure6.Wipetheitemselectionkey. 8. FollowtheFigure7towipethemeterframe. Figure7.Wipethemeterframe 9. Makesureallthedirt,dust,bloodandotherbodyfluidsarecleanedfrommeterusingthefirstwipe. Disinfection:
1. Aftercleaning,useasecondwipeandthoroughlywetthesurfacesofmeter. 2. Makesurethetreatedarearemainswetforaminutetoeffectivelykillbloodbornepathogens. 3. Ensurethetreatedareaarethoroughlydry. 4. Discardthewipesandachieveacleaning/disinfectioncycle. TestprocessA1c Cleaning:
1. 2. 3. Putoncleangloves 4. Takeonewipeandsqueezeoutexcessmoisturefromthewipebeforeuse. 5. FollowtheFigure8towipethemeterfrontandmeterscreenrespectively. Usetwowipes. Followthecleaninginstructionforthefirstwipeandthedisinfectioninstructionforthesecond. Figure8.Wipethemeterfrontandmeterscreenrespectively. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 16of26 6. FollowtheFigure9towipethemeterback. Figure9.Wipethemeterback 7. FollowtheFigure10towipetheitemselectionkey. Figure10.Wipetheitemselectionkey. 8. FollowtheFigure11towipethemeterframe. Figure11.Wipethemeterframe 9. Makesureallthedirt,dust,bloodandotherbodyfluidsarecleanedfrommeterusingthefirstwipe. Disinfection:
1. Aftercleaning,useasecondwipeandthoroughlywetthesurfacesofmeter. 2. Makesurethetreatedarearemainswetforaminutetoeffectivelykillbloodbornepathogens. 3. Ensurethetreatedareaarethoroughlydry. 4. Discardthewipesandachieveacleaning/disinfectioncycle. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 17of26 20. ErrorandWarningmessage Errormessagesandtroubleshootingtipswillbedisplayedonthescreen.Pleasepayattentiontotheerror messagesandinformationtomakesurethePixoTestPOCTSystemisperformingaccurately. Thefollowingtablelistserrormessageandtroubleshootingtips,whichmayappearonthescreenduring performingthesystem. ErrormessageA1c ErrorNumber ErrorMessage ProblemCause Note01 Measurement Failure Themeasurementisinterrupted duetoimproperoperation. Note02 SystemTilt Itisdetectedthatthetiltsduring measurement. Note03 Outofrange Temperature Theambienttemperatureisoutside therecommendedoperating temperaturerange. Note04 BloodSample Error Note05 TestStripError Nosampleorinsufficientsample volumeappliedontheteststripwas detectedafterthesystemindicates toapplythebloodsample. Invalidteststriporimproper installationoftheteststripwas detectedduringmeasurement. Note06 CalibrationError Incompleteorincorrectcalibration processwasdetected. Note07 SystemError Abnormalsignalscomingfrom hardwareproblemsweredetected WhattoDo Pleasekeeptheteststrip stabilizedanddontmovethe teststripduringmeasurement. Ifthiserrorstillhappenson bloodsampleswithnormal rangeoftotalhemoglobin, pleasecontactyoursystem provider. PleasekeepthePOCX01flat andstabilizedonatableduring measurement. Performatestinan environmentwiththe temperaturebetween1532C
(5989.6F).Donotheator coolyourPOCX01. Discardthisteststripandre testwithanewtestkit. Reinstallanewtestkitproperly andtestagain. InsertonlytheCalibrationCard providedbythemanufacturer andswitchtheItemselection keytotheA1cmodeforthe calibration.DoNotmovethe CalibrationCardduring calibration. Dothecalibrationagainandif theerrorstillpersists,please Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 18of26 duringcalibrationprocess. contactyoursystemprovider. ErrormessageLipid ErrorNumber ErrorMessage ProblemCause Note01 Note02 Measurement Failure Themeasurementisinterrupted duetoimproperoperation. LightSignal Error Themeasurementisinterrupted duetothestrongstraylightinthe stripmodule. Note03 Outofrange Temperature Theambienttemperatureisoutside therecommendedoperating temperaturerange. Note04 BloodSample Error Note05 TestStripError Nosampleorinsufficientsample volumeappliedontheteststripwas detectedafterthesystemindicates toapplythebloodsample. Invalidteststriporimproper installationoftheteststripwas detectedduringmeasurement. Note06 CalibrationError Incompleteorincorrectcalibration processwasdetected. Note07 SystemError Abnormalsignalscomingfrom hardwareproblemsweredetected duringcalibrationprocess. WhattoDo Pleasekeeptheteststrip stabilizedanddontmovethe teststripduringmeasurement. Pleasemakesurethatthestrip moduleissecurelyattached andtheslidingdoorisclosed completely. Performatestinan environmentwiththe temperaturebetween1832C
(64.489.6F).Donotheator coolyourPOCX01. Discardthisteststripandre testwithanewtestkit. Reinstallanewtestkitproperly andtestagain. InsertonlytheCalibrationCard providedbythemanufacturer andswitchtheItemselection keytotheA1cmodeforthe calibration.DoNotmovethe CalibrationCardduring calibration. Dothecalibrationagainandif theerrorstillpersists,please contactyoursystemprovider. 21.Disposalinformation Discardtheusedteststripscarefully.Usedteststripsmaybeconsideredasbiohazardouswasteinyourarea. Handleanddisposeofallmaterialscomingincontactwithbloodaccordingtouniversalprecautionsand guidelines.Washyourhandswithsoapandwaterafterhandlingtheteststrip. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 19of26 22.Productinformation Specification POCX01Analyzer Dimension Weight Power storage Operating 181mm(L)x111mm(W)x53mm(H) 131.3g 5000mAhbattery,nonremovable 10000sets Temperature10~40(50 ~104 ) Humidity10%~90%RH Operationatmosphericpressurerange 760mmHg~526mmHg Storage&Transportationcondition Temperature1~40(34 ~104 ) CalibrationCard others Charger USversion ENversion UKversion Humidity10%~90%RH Storedinthepackagepouchandwith1yearsshelflife Indooruse OvervoltagecategoryII Pollutiondegrees2 Manufacture:DONGGUANAOHAIPOWERTECHNOLOGY CO.,LTD. Model:A18A050100UUS2 Input:100240V~50/60HzMax0.2A Output:5V1.0A Manufacture:DONGGUANAOHAIPOWERTECHNOLOGY CO.,LTD. Model:A824A120150UEU1 Input:100240V~50/60Hz0.5A Output:5V2.0A/9V2A/12V1.5A Manufacture:DONGGUANAOHAIPOWERTECHNOLOGY CO.,LTD. Model:A806050100UUK1 Input:100240V~50/60Hz0.2A Output:5V1.0A Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 20of26 TeststripforLipid MeasuringRange TC:100 450mg/dL,(2.59 11.64mmol/L) TG:45650mg/dL,(0.517.34mmol/L) HDL:2595mg/dL,(0.652.46mmol/L) Freshcapillaryorvenouswholeblood 35L 3minutes TC/TG:3055%;HDL:3052%
18 32C(64 90F) 2 32C(36 90F) 18months Sample SampleSize TestTime Hematocrit OperatingTemperatureRange TestStripStorageTemperature Shelflife
*:Teststripmaybestoredinarefrigeratorat28C(3646F),butmustbebroughttoroomtemperature beforeuse. TeststripforA1c MeasuringRange Sample SampleSize TestTime Hematocrit OperatingTemperatureRange TestStripStorageTemperature*
Shelflife
*:Teststripmaybestoredinarefrigeratorat28C(3646F),butmustbebroughttoroomtemperature beforeuse. 4.0 15.0%
Freshcapillaryorvenouswholeblood 5L 3minutes 25 65%
15 32C(5990F) 1 30C(34to86F) 18months 23.Limitations PixoTestA1cTestStrip 1.Thebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem. 2.DonotchargeyoursmartphonewhenyouusethePixoTextPOCTSystem. 3.PixoTestPOCTSystemcanperformsinthehemoglobinarangeof723g/dLandahematocritrangeof25to 4.PerformanceofPixoTestPOCTSystemhasnotbeentestedonsamplesfromnewborns. 5.Cosmeticssuchashandcreamsorlotionsoftencontainglycerol.Useoftheseproductsmaycauseinaccurate 6.Forinvitrodiagnosticuseonly. 7.PixoTestA1cTestStripisforsingleuse. 8.Donotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriatelight 65%. results. environment.
> 30 mg/dL Acetylsalicylic acid Substances concentration (mg/dL) 9.Strongelectromagneticfields(e.g.microwaveovens)mayaffectperformance. 10.Interferences:Thefollowingsubstancesmaycausefalseresultsatlevelsofthebelow. Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 21of26 Ascorbic acid Acetaminophenol Billirubin Caffeine Hydroxyzine Dihydrocholoride Triglyceride Glyburide Ibuprofen Dopamine
> 10 mg/dL
> 30 mg/dL
> 20 mg/dL
> 30 mg/dL
> 30 mg/dL
> 900 mg/dL
> 20 mg/dL
> 20 mg/dL
> 2 mg/dL PixoTestLipidTestStrip 1.Thebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem. 2.DonotchargePOCX01whenyouusethePixoTextPOCTSystem. 3.Hematocritsof30to55%(TC/TG),30to52%(HDL)forLipidTestStripdonotaffectresults. 4.PerformanceofPixoTestPOCTSystemhasnotbeentestedonsamplesfromnewborns. 5.Cosmeticssuchashandcreamsorlotionsoftencontainglycerol.Useoftheseproductsmaycauseinaccurate 6.Forinvitrodiagnosticuseonly. 7.Teststripisforsingleuse. 8.Donotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriatelight results. environment. 9.Strongelectromagneticfields(e.g.microwaveovens)mayaffectperformance. 10.Interferences:Thefollowingsubstancesmaycausefalseresultsatlevelsofthebelow. 24.Manufacturer iXensorCo.,Ltd. 6F.,No.9,Aly.2,Ln.35,JihuRd.,NeihuDist.,TaipeiCity,11492,Taiwan www.ixensor.com Authorizedrepresentative MDSSGmbH Schiffgraben4130175Hannover,Germany 25.Symbol Cataloguenumber Consultinstructionsforuse Authorizedrepresentative intheEuropeanCommunity Manufacturer BatchCode Usebydate Donotreuse Serialnumberoftheanalyzer ContainsSufficientfor
<n>Tests Temperaturelimitation DateofManufacture InvitrodiagnosticUse Caution, Consultaccompanyingdocuments Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 22of26 26.Servicing ThePixoTestPOCTSystemsisintendedtoprovidesafeandreliableoperationaccordingto theinstructionsprovidedbyiXensorCo.,Ltd.iXensorCo.,LtdrecommendsthatthePixoTest POCTsystemcanbeinspectedandservicedbyauthorizedtechniciansifthereisanyconcern withdevicefunction.Otherwise,serviceandinspectionofthedevicesgenerallyshouldnot berequiredifusedbyfollowingtheinstructionforuse. 27.LimitedWarranty iXensorCo.,Ltd(hereafteriXensor)givesthecustomeralimitedmanufacturerwarranty onneworiginaliXensorproductsandrelativeaccessoriesinaccordancewiththewarranty conditionsapplicabletotheiteminquestionandinaccordancewiththewarrantyperiods frompurchasedate,pleaserefertothelistasbelow.Thiswarrantydoesnotcoverdamage caused by operator himself, accident, misuse, abuse, alteration and other defects not relatedtomaterialorworkmanship.Toexerciseyourrightsunderthiswarranty,please contactyourlocal,authorizeddistributorsorservicecenter. Item PixoTestPOCTAnalyzer USBCharger PixoTestPOCTCalibrationCard USBTypeCChargeCable Otherdisposableparts Warrantyperiod 1year 1year 1year None None CustomerName:
______________________________________________________________________ _ CustomerAddress:
_______________________________________________________________ ___ __ Telephone: ____________________________ Emailaddress: _________________________________ Dateofpurchase:_____________________________________________________ Distributorinformation:
Instruction for Use Doc.No. CDMC01C3IFUPOCX1ALL01 FT730100080007A 23of26 Appendix1:Reference 1. AmericanDiabetesAssociation,ClinicalPracticeRecommendationGuidelines2003,Diabetescare,Vol.26. Supplement1.p.22 2. Stedman,TL.StedmansMedicalDictionary,27thEdition,1999,p.2082. 3. EllenT.Chen,JamesH.Nichols,ShowHongDuh,GlenHortin,MD:DiabetesTechnology&Therapeutics, PerformanceEvaluationofBloodGlucoseMonitoringDevices,Oct2003,Vol.5,No.5:749768 4. SiedelJ,HageleEO,ZiegenhormJ,WahlefeldAW.Reagentfortheenzymaticdeterminationofserumtotal cholesterolwithimprovedlipolyticefficiency.ClinChem1983;29:107580. 5. ExpertPanelonDetection,Evaluation,andTreatmentofHighCholesterolinAdults.Executivesummaryof theThirdReportoftheNationalCholesterolEducationProgram(NCEP)ExpertPanelonDetection,Evaluation, andTreatmentofHighCholesterolinAdults(AdultTreatmentPanelIII).JAMA2001;285:248697. 6. IDFClinicalGuidelinesTaskForce.GlobalguidelineforType2diabetes.Brussels;InternationalDiabetes Federation,2005. 7. Definitionanddiagnosisofdiabetesmellitusandintermediatehyperglycemia:reportofaWHO/IDF consultation.WHO,Geneva2006(ISBN9241594934,ISBN9789841597936). 8. DOrazioetal.:ApprovedIFCCRecommendationofReportingResultsforBloodGlucose(Abbreviated);
ClinicalChemistry51:915731576(2005). 9. AmericanDiabetesAssociation,PositionStatement,DiagnosisandClassificationofDiabetesMellitus, DiabetesCare35:S4S10,2012. 10. AmericanDiabetesAssociation:ClinicalPracticeRecommendations(2013)DiabetesCare,Vol36, Supplement1,p.S1S100 FCC Caution: To assure continued compliance, any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. (Example - use only shielded interface cables when connecting to computer or peripheral devices). FCC Radiation Exposure Statement This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device complies with Part 15, 22, 24 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. SAR: 0.73 W/Kg Instruction for Use FT730100080007A Doc.No. CDMC01C3IFUPOCX1ALL01 24of26