iXensor POC-X01 PixoTest POCT Analyzer User Manual

iXensor Co. Ltd. PixoTest POCT Analyzer Users Manual

Users Manual

文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A2of26InstructionsforUsePixoTestPointofCareTest(POCT)System
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A3of26TheInstructionforUseofPixoTestPOCTSystemonPixoTestA1c&Lipidteststrip............11.Indicationforuse................................................................................................................42.Testprinciple.......................................................................................................................43.Beforetest..........................................................................................................................44.ThePixoTestPOCTSystemincludes................................................................................55.Teststrip.............................................................................................................................56.Settings...............................................................................................................................67.Preparingformeasurement...............................................................................................68.Runningtest‐A1c.................................................................................................................79.Runningtest‐lipid................................................................................................................910.Understandingresult..........................................................................................................911.Record...............................................................................................................................1012.Calibration.........................................................................................................................1113.Controlsolutiontest.........................................................................................................1114.CStestforA1c...................................................................................................................1215.CStestforLipid.................................................................................................................1316.ControlSolutionrangeandmeaning................................................................................1317.Shutdownprocedure........................................................................................................1318.Maintenanceandtroubleshooting...................................................................................1419.Cleananddisinfection......................................................................................................1420.ErrorandWarningmessage.............................................................................................1821.Disposalinformation.........................................................................................................2022.Productinformation.........................................................................................................2023.Limitation..........................................................................................................................2224.Manufacturer....................................................................................................................2225.Symbol..............................................................................................................................2226.Servicing............................................................................................................................2327.LimitedWarranty..............................................................................................................23
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A4of26Appendix1:Reference……………………………………………………………………………………………………………………………………..241. IndicationforuseTheiXensorPixoTestPOCTSystemiscomprisedofPixoTestA1c/LipidTestStrip,PixoTestPOCTAnalyzer,PixoTestPOCTCalibrationCard,andthePixoHealthPOCT‐A1c/LipidAPPasthedisplaycomponentofthesystem.TheiXensorPixoTestPOCTSystemisintendedtobeusedforthequantitativemeasurementofHbA1candLipids(includingTotalciholesterol,Triglycerides,andHigh‐DensityLipoprotein(HDL)cholesterol)inwholebloodfrombothcapillaryandvenous.EstimatedvaluesforLow‐DensityLipoprotein(LDL)cholesterolarecalculatedbythePoxoHealthPOCT‐LipidAPP.ThePixoTestPOCTSystemisaprofessionaluseonlyproductandintendedforinvitrodiagnosticuseandisnotintendedforuseonneonates. Untrainedpersonnelcouldperformitwell2. TestprincipleTheiXensorPixoTestPOCTSystemcombinesenzymaticmethodologyandreflectancephotometrytomeasureHbA1candLipids.Samplesfrombothcapillaryandvenouswholebloodcanbeused.ThiswholebloodsampleisappliedtoPixoTestA1c/LipidTestStrip,andareactionoccurstoproduceacolorthatisreadbyusingreflectancephotometryofthereagentarea.Thelevelofcolorproducedisproportionaltotheconcentration.PixoTestPOCTSystem‐A1cusesananti‐HbA1c(%)antibodywhichisspecificforthefirstfewaminoacidresiduesoftheglycatedN‐terminusoftheß‐chainofhemoglobinA0.PixoTestA1cTestKitcontainsthePixoTestA1cTestStrip(nitrocellulosemembrane),Spoitwithlatex‐tablet(bluedyedlatexmicroparticlesconjugatedtospecificantibodies)andBuffersolutiontube(hemolysisreagent).Whenwholebloodisaddedtothebuffersolutionandismixedwiththelatex‐tablet,theerythrocytesareinstantlylysedtoreleasetheglycatedhemoglobin(hereafter,HbA1c).Whenthesamplemixtureisloadedontothesampleportofthetestpanel,themixturefluidmigratesalongthemembraneofthetestpanelbycapillaryaction,andtheHbA1cisthenimmobilizedontotheanti‐HbA1cantibodycoatedline.Theamountoftheblueconjugatesontheanti‐HbA1clinereflectstheamountofHbA1cinthesample,theintensityofhemoglobincolormeasuredfromthedesiredareaonthemembraneoftestpanelismeasured.ChemicalandimmunereactionthatoccursontheteststripismeasuredbytheopticalsysteminPixoTestPOCTSystem.ThissystemmeasuresbothfractionsandanalgorithmwhichconvertstheresultintothepercentageHbA1cinthesample.PixoTestPOCTSystem‐LipidscombinesenzymaticmethodologyandreflectancephotometrytomeasureTotalcholesterol,Triglycerides,andHDLcholesterol.WhenwholebloodsampleisappliedtoPixoTestLipidTestStrip,thebloodreactstoproducecolorthatisreadbyusingreflectancephotometryofthereagentarea.Thelevelofcolorproducedisproportionaltotheconcentration.AlllipidenzymaticreactionscanrefertoLipidteststripinsert.3. BeforetestBeforeusingthisproducttotestyourA1candLipids,carefullyreadthisInstructionforUse.PriortolaunchingthePixoHealthPOCTA1c/LipidsApp,usethePixoTestPOCTCalibrationCardtoverifythatthePixoTestPOCTSystemisworkingproperly.TheA1c/LipidsControlSolutionisusedtoverifythatthePixoTestPOCTSystemandPixoTestA1c/LipidTestStripareworkingproperly.NOTEThebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem.DonotchargeyourPixoTestPOCTSystemwhenitisinuse.Ifthebatteryisbelow20%orcharging,anerrorwillappearandthetestcannotbestarted.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A5of264. ThePixoTestPOCTSystemincludesThePixoTestPOCTAnalyzer:*PixoHealthPOCTA1c/LipidApp*USBTypeCChargeCable*USBCharger*Test StripInsert*IndicationsForUse *PixoTestPOCTCalibrationCardFig.1FrontsightofPixoTestPOCTAnalyzer(POC‐X01)Fig.2BacksightofPixoTestPOCTAnalyzer(POC‐X01)5. TeststripPixoTestPOCTSystemincludesPixoTestPOCTA1cTestkitandPixoTestPOCTLipidTestStrip(bothsoldseparately).Thefollowingcontentsareincluded:PixoTestPOCTA1cTestkit(usewithPixoTestPOCTAnalyzer):• 20PixoTestA1cTestStrips(fordifferentpackage)• 20Spoitwithlatex‐tablet• 20Buffersolutiontube• 1packageinsertADisplayShowsatestresult,messages,andthetestresultsstoredinmemory.BSlidingDoorOpentoapplysample.CItemSelectionKeySelectmeasurementmode.D PowerKeyPresstoturnanalyzerONorOFF.EUSBChargePortChargetheanalyzer.FProtectionCoverRemovetoclean.GLipidTestStripSlotInsertalipidteststriphere.HA1cTestStripSlotInsertA1cteststriphere.IStripModuleJStripModuleLockSwitchUnlocktochangethestripmodule.KCameraModuleScanQRcode
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A6of26PixoTestPOCTLipidTestStrip(usewithPixoTestPOCTAnalyzer):• 25PixoTestLipidTestStrips(fordifferentpackage)• 1packageinsert6. SettingsWhenusingthePixoTestPOCTSystemforthefirsttime,performthefollowingsteps:Step1.PressthePowerKeyfor2secondstoturnontheAnalyzer.Step2.SlideupthescreentounlocktheAnalyzer.Step3.Select“Language”option.Theselectedlanguageisshownonthe2ndlineitem.Step4.TurnontheWificonnection,typinginthepasswordifnecessary.Connectionstatusisshownatthe2ndlineitem.Step5.Click“VersionCheck”toverifythatthemostup‐to‐dateAPPversionisinstalledorneedstobeupdated.Step6.Select“TimeZone”optiontosetthe24‐hourFormat,andmanuallyselectthecorrecttimezone.Step7.Press“Next”ontheSystemActivationscreentoscantheproductkeywhichisprovidedbythelocaldistributorortheservicecentertoactivatetheanalyzer.Onceitisactivated,press“Finish”buttontocompleteallsettings.OnHomescreen,themainscreenofthePixoTestPOCTsystem,pressthe“Settings”buttonforthechangeofthesystemsettings,includesLanguage,WifiandTimeZone.NOTEAftercompletingallsettings,acalibrationisrequiredbeforeoperating,andmustbedonedaily.RefertoChapter13forthecalibrationprocess.7. PreparingformeasurementTheiXensorPixoTestPOCTSystem• PixoTestA1c/LipidTestStrip• PixoTestPOCTAnalyzer:POC‐X01• PixoHealthPOCT‐A1c/LipidAPP• PixoTestPOCTCalibrationCard• A1c/LipidControlSolution• Spoitwithlatex‐tabletandBuffersolutiontubeforA1ctest• 35µltubeforLipidtest*• Instructionsforuse• Additionalrequiredmaterials:• Alcoholswabstocleanpuncturesite• TheEPA‐registereddisinfectantwipestodisinfectthesurfaceofPOCTsystem• Lancetsforcapillaryorvenousbloodcollectionsupplies(vacuumcollectiontubes,needlesandtubeholders)• Gloves• BiohazardwastecontainersNOTE*:35µltubearenotincludedandcanbepurchasedfromalocaldistributor;collectsamplewithasuitabletoolfor35µL(ex:micropipetteorquantitativedropper.)
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A7of26POC‐X01PixoTestPOCTSystemisintendedtomonitorA1candLipidsusingPOC‐X01(Fig.1)toconductthetest.Itemselectionkey:TotestA1C,slidetheItemSelectionkeytothe“II”indication.TotestLipids,slidetheitemselectionkeytothe“I”indication.Slidingdoor:WhentestingLipids,opentheslidingdoortoinsertthePixoTestlipidteststripintotheLipidTestStripSlot.A1cTestStripSlot:ToinsertthePixoTestA1cteststripintotheA1cteststripslot(Fig.2).LipidTestStripSlot:ToinsertthePixoTestlipidteststripintothelipidteststripslot(Fig.2)CAUTION• KeepPixoTestLipidTestStripstoredinadryplacebetween36–90°F(2–32°C),andavoiddirectsunexposure.• KeepA1cTestStripstoredinadryplacebetween34–86°F(1–30°C),andavoiddirectsunexposure.• DoNotopentheteststrippackageuntilreadytoperformthetest.Useteststripimmediatelyafterremovalfromthepackage.• DoNotreturntheusedteststriptotheoriginalboxafterperformingthetest;disposeofusedteststrip.• DoNotre‐useateststripthathadbloodorcontrolsolutionappliedtoit.Thestripisforsingleuseonly.• DoNotmodifytheteststripinanyway.• DoNotuseyourPixoTestA1c/LipidTestStripifthepackageisdamagedorleftopentoair.• DoNotusethedevicenearsourcesofelectromagneticradiationsuchasmicrowaves.• DoNotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriatelightenvironment.• DoNotuseteststripaftertheexpirationdate(printedonthepackage)oryourresultsmaybeinaccurate.• AlwayskeepPOC‐X01clean.• Confirmthatthecodenumberisthesameasthecodeonthefoilpouchpackage.• Toconservepower,theAnalyzerturnsitselfoffafter10minutesunlessapowerbuttonispressed.WhentheAnalyzerturnsitselfoff,alltestresultsobtainedsofarremaininthememory.• Whenthelowbatterywarning(lessthan20%)appears,atestcannotbeperformed.ChargetheAnalyzerimmediately.• Measurementresults,includingtherelatedmeasurementdateandtimeaswellasallotherAnalyzersettings,remainstoredevenwhenthereisnopower.8. Runningtest‐A1cStep1.Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely.Step2.Tap“Settings”buttonontheHomescreenofPixoTestPOCTSystemandtap“A1c” buttontoopenthePixoHealthPOCT‐A1cApp.Step3.Tap“Renew”toscantheQRcode,pastedontheteststripbox.Step4.Tap“Next”buttontostartA1cmeasurement.Step5.Pleaseslidetheitemselectionkeytothe“II”indication.Checkthestripcodenumberandinserttheteststripintheslot.Press“initialize”buttonforinitialization.NOTE1. PleasemakesurethePOC‐X01isplacedonaflatsurface.2. Thesystemshowsthenumberoftheremainingtest.PleaseopenanewstripboxandscanitsQRcodetoresetthecountingwhentheremainingtestsreacheszero.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A8of26Step6.Obtainabloodsampleusingthelancetandlancingdevice.(Ifyouusethevenousblood,checkthecollectiondateandtheanticoagulant.)Step7.Collectthe5µlbloodsampleandputitinthebuffersolutiontube.Step8.Mixthebuffersolutionandbloodsamplebygentlysqueezingtherubbertopofthespot6‐8times.NOTE1.Blocktheholeonthestopofthespotwhilemixing.2.Avoidbubbleswhilemixing.12Step9.Collectallthereactionmixturefromthebuffersolutiontube.Oncethe“ApplyBlood”animationonthescreen,thebloodsamplecanbeappliedontheteststrip.TheA1ctestresultwillappearafter3minutes.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A9of269. Runningtest‐lipidStep1.Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely.Step2.Tap“Settings”buttononHomescreenofPixoTestPOCTSystemandtap“Lipid”buttontoopenthePixoHealthPOCT‐LipidApp.Step3.Tap“Renew”toscantheQRcodepastedontheteststripbox.Step4.Tap“Next”buttontostartthelipidmeasurement.Step5.Pleaseslidetheitemselectionkeytothe“I”indication.Checkthestripcodenumberandinserttheteststripintheslot.Press“initialize”buttonforinitialization.Step6.Obtainadropofbloodsampleusingthelancetandlancingdevice.Step7.Collecta35µlbloodsampleusingthetube.Placethebloodsampleintotheapplicationholeoftheteststrip.Then,closetheslidingdoor.Step8.Lipidtestresultwillappearafter3minutes.NOTEThesystemshowsthenumberoftheremainingtest.PleaseopenanewstripboxandscanitsQRcodetoresetthecountingwhentheremainingtestsreacheszero.10. UnderstandingresultMeasuringRangeTeststripscanmeasurenumericalresultsinthefollowingranges:• HbA1c:4‐15%(68.1–383.8mg/dL,3.77–21.26mmol/L)• TotalCholesterol:100–450mg/dL(2.59–11.64mmol/L)• Triglycerides:45–650mg/dL(0.51–7.34mmol/L)• HDLcholesterol:25–95mg/dL(0.65–2.46mmol/L)• LDLcalculatedrange:66‐225mg/dL(1.71~5.82mmol/L)
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A10of26Iftheresultisoutsidethemeasuringrange,thesystemwilldisplay“Hi”whentheresultsareabovethemeasuringrange,anddisplay“Lo”whentheresultsarebelowthemeasuringrange.CAUTIONIfthereisa“Lo/Hi”oranunexpectedresultforanytest,testagainwithanewteststrip.11. RecordReviewingPastResultsOpenupthePixoHealthPOCT‐A1c/LipidApp.Threefunctionbuttonswillappearonthescreen.Tapthe“Records”icontorevieweachpastresultbydateandtime.A1cRecordsLipidRecordsExpectedValuesA1c:%HbA1cInterpretationofresults Displaycolor<=5.6%NonDiabeticRange Green5.6%‐6.5%ADA(AmericanDiabetesAssociation)Target Yellow>=6.5%AboveTargetRedLipid:ThenationalHeart,LungandBloodInstituteissuedtheThirdReportofNationalCholesterolEducationProgram(NCEP)ExpertPanelonDetection,Evaluation,andTreatmentofHighBloodCholesterolinAdults(AdultTreatmentPanelIII)inMay2001.TheATPIIIreportpresentedtheNCEP’supdatedclinicalguidelinesforcholesteroltestingandmanagementanddescribedthefollowingclassificationsforcholesterolandtriglyceridetesting.mg/dLmmol/L Classification DisplaycolorTC(TotalCholesterol)<200<5.18 Desirable Green200‐239 5.18‐6.19 Borderlinehigh Yellow>=240>=6.22 High RedTG(Triglycerides)<150<1.69 Normal Green150‐199 1.69‐2.25 Borderlinehigh Yellow>=200>=2.26 High RedHDL<40<1.03 Low Black>=60>=1.55 High BlackLDL<100<2.59 Optimal Black100‐129 2.59‐3.34 Nearoptimal/aboveoptimalBlack130‐159 3.36‐4.11 Borderlinehigh Black160‐189 4.14‐4.89 High Black>=190>=4.91 Veryhigh Black
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A11of26TheATPIIIidentifiedHDLlevelsbelow40mg/dL(1.03mmol/L)asassociatedwithincreasedriskofcoronaryheartdisease(CHD)inmenandwomen.AhighHDLlevelgreaterthanorequalto60mg/dL(1.55mmol/L)isprotectiveanddecreasesCHDrisk.LDLLDLcanbecalculatedusingtheequationbelow.CalculatedLDLisanestimationofLDL,definedbythespecificationofTC,TG,andHDL.• LDL(calculated)=TotalCholesterol‐HDL‐(Triglyceride/5)(mg/dL)• LDL(calculated)=TotalCholesterol‐HDL‐(Triglyceride/2.17)(mmol/L)12. CalibrationThePixotTestPOCTsystemwillautomaticallyalerttheUsertocompleteacalibration.TheusermusttocompletethecalibrationwithPixoTestPOCTCalibrationCard.PixoTestPOCTCalibrationCardisusedtocalibratethePixoTestPOCTsystemandtoconfirmthefunctionofthefrontcameraandPixoHealthPOCT‐A1c/LipidApp.ThePixoTestPOCTSystemmustbecalibrateddaily.Ifthishasnotbeencompleted,thePixoHealthPOCTA1c/LipidAppwillnotbeabletoperformtestsuntilcalibrationhascompleted.WhentodoaCalibration:• WhenusinganewboxofA1c/LipidTestStrip.• Whenthereisanunexpectedtestresult.WheretoperformaCalibration:• Thesystemshows“CALIBRATION”ontheHomescreenautomaticallyatthefirsttimeusingtheAnalyzereveryday.Tapthe“Calibration”buttontostartthecalibrationprocess.• Toperformacalibrationanytime,tap“Settings”buttononHomescreenofPixoTestPOCTsystemandtap“Calibration”buttontostartthecalibrationprocess.• Acalibrationtestcanbeinitializedfromthe“Settings”ofPixoHealthPOCT‐A1c/LipidAppanytime.HowtoCalibrate:Step1:Pleaseslidetheitemselectionkeytothe“II”indication.InserttheCalibrationcardintotheA1cslotandpress“Calibrate”button.Step2:TheAPPwillautomaticallystartthecalibration.Waitforafewsecondstocompletethecalibration.Step3:Whenthecalibrationiscomplete,tap“Confirm”tocontinuethetestingmode.NOTE1.Avoidlongexposurestolight.2.Avoidtouchingfinishedsurfaceoncolorblockofcalibrationcard.3.Keepcalibrationcardinblackprotectivesheathwhencompletedcalibration.13. ControlsolutiontestiXensorCo.Ltd.doesnotprovidecontrolsolutions,Bio‐RadcontrolsolutionofA1candLipidare
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A12of26recommendedforPixoTestPOCTSystem:A1c:Bio‐RadLiquicheckDiabetesControl(level1,2),Cat#171,172Lipid:Bio‐RadLiquicheckLipidsControl(level1,2),Cat#641,642TheControlSolutionisusedtoverifythatthePixoTestPOCTSystemisworkingproperly(A1c/LipidControlSolutionaresoldseparately).Topurchasethecontrolsolution,pleasecontactiXensorCo.Ltd.tollfreeat1‐800‐218‐0929,Mon‐Fri9AM‐5PM(PST).WhentodoaA1c/LipidControlSolutionTest• Ifthestrip,PixoHealthPOCT‐A1c/LipidApporPOCT‐X01seemstonotbeworkingproperly.• Ifthetestingresultsareunusualorunexpected.• IftheAnalyzerhasbeendroppedordamaged.CAUTION• UseonlytheBioRadA1c/LipidcontrolsolutiontoverifythatthePixoTestPOCTSystemisworkingproperly.Donotuseanyotherbrandofcontrolsolution.• A1c/LipidControlSolutionisforinvitrodiagnosticuseonly.Thismeansthatisonlyusedfortestingoutsideofthebody.• DoNotswalloworingestA1c/Lipidcontrolsolution.• DoNotuseA1c/Lipidcontrolsolutionaftertheexpirationdate(printedoncontrolsolutionbottle,shelflife:3yearat‐20℃to‐70℃)orthediscarddate(14daysfromthedatethecontrolsolutionvialwasopened),whichevercomesfirst.Usingthesolutionaftertheexpirationordiscarddatewillcauseyourresultstobeinaccurate.14. CStestforA1cStep1:Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely.Step2:CleananddisinfecttheAnalyzersurfaceasinstructed.Startacontrolsolutiontestbytappingtheicon“Settings”andselect“ControlSolutionTest ” optioninthePixoHealthPOCT‐A1cApp.Step3:ThemainscreenofControlSolutionTest listsalltestresults,tapthe“Starttesting”buttontoentertheTest Infoscreen.Step4:Tap“Renew”toscanthecodeontheteststripboxifthecodehasn’tbeenscanned.Andpress“Next”buttontostartthetest.Step5:Pleaseslidetheitemselectionkeytothe“II”indication.Checkthestripcodenumberandinserttheteststripintheslot.Press“initialize”buttonforinitialization.Step6:Oncethecontrolsolution‐applyinganimationisdisplayedonthescreen,obtainacontrolsolutionsampleofLevel1orLevel2andapplythecontrolsolutionontheteststrip.Thetestresultwillappearafter3minutes.NOTE1. PleasemakesuretheAnalyzerisplacedonaflatsurface.2. Thesystemshowsthenumberofremainingtests.PleaseopenanewstripboxandscanitsQRcodetoresetthecountingwhentheremainingtestsreacheszero.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A13of2615. CStestforLipidStep1:Beforetesting,washyourhandswithwarm,soapywater.Rinseanddrycompletely.Step2:CleananddisinfecttheAnalyzersurfaceasinstructed.Startacontrolsolutiontestbytappingtheicon“Settings”andselect“ControlSolutionTest ”inthePixoHealthPOCT‐LipidApp.Step3:ThemainscreenofControlSolutionTest listsalltestresults,tapthe“Starttesting”buttontoentertheTest Infoscreen.Step4:Tap“Renew”toscanthecodeontheteststripboxifthecodehasn’tbeenscanned.Andpress“Next”buttontostartthetest.Step5:Pleaseslidetheitemselectionkeytothe“I”indication.Checkthestripcodenumberandinserttheteststripintheslot.Press“initialize”buttonforinitialization.Step6:Obtainacontrolsolutionsampleusingthe35µltube.Step7:Collectthe35µlcontrolsolutionusingthetubeandplacethecontrolsolutionsampletotheapplicationholeoftheteststrip,thenclosetheslidingdoor.Step8:Lipidcontrolsolutiontestresultwillappearafter3minutes.NOTE1. Thesystemshowsthenumberoftheremainingtests.PleaseopenanewstripboxandscanitsQRcodetoresetthecountingwhentheremainingtestsreacheszero.2. Removeanddiscardtheusedteststrip.Donotaddmorebloodtoausedteststrip.16. ControlSolutionrangeandmeaningOutofRangeResultsAftercontrolsolutiontest,checktheresultofthecontrolsolutionvalueandconfirmitiswithinrange.Iftestresultsfalloutsideoftheexpectedrange,pleaserepeatthetest.DonotcontinuewithyourA1c/Lipidtestifthecontrolsolutiontestresultsarecontinuouslyoutofrange.Resultsthatfalloutsideoftheexpectedrangemayindicate:• Testisnotperformedatroomtemperature.• Controlsolutionhasexpired,isbeyonditsdiscarddate,orcontaminated.• AtechnicalproblemwithyourPixoTestPOCTSystem.• Controlsolutionthatistoowarmortoocold.• AproblemwiththeTestStrip(expiredordamaged).• Anerrorcallsduringthetest.17. ShutdownprocedureWhenfinishusingthePixoTestPOCTSystem,followthestepstoturntheAnalyzeroff:Step1.PressthePowerKeyfor2seconds.Step2.Tap“Poweroff”toturnofftheAnalyzer.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A14of2618. MaintenanceandtroubleshootingCaringforthePixoTestPOCTSystemiseasy.Simplykeepitfreeofdust.Ifthesystemneedscleaning,followtheseguidelinescarefullytoobtainthebestperformance.TopreventmalfunctionoftheAnalyzer,keeptheteststripslotfreeofblood,dirt,ordust.Usealint‐freeclothdampenedwithwatertocleantheAnalyzer.Ensuretheclothisdamp,andnotwet.Donotuseanabrasiveclothorantisepticsolution,asthesemaydamagethedisplayscreen.Acleanopticalmeasuringsystemisabasicprerequisitefordeterminingprecisemeasuredvalues.Therefore,cleantheAnalyzerregularlyandimmediatelyafteritbecomesdirty.AlwaysswitchofftheAnalyzerbeforecleaningit.Useonlythefollowingitemsforcleaning:• Ordinarylint‐freecottonbuds• Ordinarylint‐freetissues• Ordinarydisinfectingtissues• DonotuseanydisinfectantspraysortissuesorcottonbudswhicharedrippingwetastheliquidmayentertheAnalyzeranddamageit.CleaningtheouterAnalyzercomponents1. WipetheoutsideoftheAnalyzerwithalightlymoistened,lint‐freecottoncloth.2. Removetheprotectioncover.3. Incaseofsignificantdirt,youcanrinsetheprotectioncover(separatelyfromtheAnalyzer)underwarmrunningwater.4. Drythemeasurementchambercoverwithafreshcloth.Cleaningtheopticalmeasuringsystem1. Removethestripmodule.2. Cleantheeasilyaccessibleareasoftheopticalmeasuringsystemwithalint‐freepadoramoistenedcottonswab.MakesurethatnoliquidenterstheAnalyzer.3. AllowtheAnalyzertodrythoroughly.4. DonotfitthestripmoduleintotheAnalyzeruntilitiscompletelydry.5. FitthestripmoduleintoAnalyzer.6. TheAnalyzerisnowreadyforoperationagainMaintenance,TestingandTransportationAnalyzer1. Keeptheteststripslotsfreeofdust.2. ProtecttheinternalAnalyzerfromhumidity.3. Therearenoeffectsonproductqualityinenvironmentaltemperaturesof‐20–50°C(‐4–122°F)during8hoursandhumidityofupto93%RH,non‐condensingduring8hours.19. CleananddisinfectionDuetotheriskofspreadingbloodborninfections,cleananddisinfectthePOC‐X01aftereverybloodtest.CleanthePOC‐X01toremovevisibledirt,bloodorothermaterialspriortodisinfecting.Followwithasecondwipetodisinfectthemeasurementmodule.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A15of26 CleananddisinfectthemeasurementmoduleatleastonceperweekandwhenbloodispresentonthesurfaceofthePOC‐X01. FordisinfectingyourPOC‐X01,onlyuseCloroxHealthcareBleachGermicidalWipes(EPA*reg.no.67619–12),containingSodiumHypochlorite0.55%.[CanbepurchasedfromAmazon.com,Officedepot.comandWalmart.com]. Donotuseanyothercleaningordisinfectingsolutions. UseofdisinfectingproductsotherthanCloroxHealthcareBleachGermicidalWipeshavenotbeenvalidatedforthePixoTestPOCTSystemhavenotbeenvalidated.AlwaysuseCloroxHealthcareBleachGermicidalWipes.Testprocess–LipidUsetwowipes.Followthecleaninginstructionforthefirstwipeandthedisinfectioninstructionforthesecond.Cleaning:1. Followthecleaninginstructionfirst.2. Putoncleangloves3. Takeonewipeandsqueezeoutexcessmoisturefromthewipebeforeuse.4. FollowtheFigure3towipethemeterfrontandmeterscreenrespectively.Figure3.Wipethemeterfrontandmeterscreenrespectively.5. FollowtheFigure4towipethemeterback.Figure4.Wipethemeterback6. FollowtheFigure5towipetheinsertionareaofstrip.Figure5.Wipetheinsertionareaofstrip
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A16of267. FollowtheFigure6towipetheitemselectionkey.Figure6.Wipetheitemselectionkey.8. FollowtheFigure7towipethemeterframe.Figure7.Wipethemeterframe9. Makesureallthedirt,dust,bloodandotherbodyfluidsarecleanedfrommeterusingthefirstwipe.Disinfection:1. Aftercleaning,useasecondwipeandthoroughlywetthesurfacesofmeter.2. Makesurethetreatedarearemainswetforaminutetoeffectivelykillblood‐bornepathogens.3. Ensurethetreatedareaarethoroughlydry.4. Discardthewipesandachieveacleaning/disinfectioncycle.Testprocess–A1cCleaning:1. Usetwowipes.2. Followthecleaninginstructionforthefirstwipeandthedisinfectioninstructionforthesecond.3. Putoncleangloves4. Takeonewipeandsqueezeoutexcessmoisturefromthewipebeforeuse.5. FollowtheFigure8towipethemeterfrontandmeterscreenrespectively.Figure8.Wipethemeterfrontandmeterscreenrespectively.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A17of266. FollowtheFigure9towipethemeterback.Figure9.Wipethemeterback7. FollowtheFigure10towipetheitemselectionkey.Figure10.Wipetheitemselectionkey.8. FollowtheFigure11towipethemeterframe.Figure11.Wipethemeterframe9. Makesureallthedirt,dust,bloodandotherbodyfluidsarecleanedfrommeterusingthefirstwipe.Disinfection:1. Aftercleaning,useasecondwipeandthoroughlywetthesurfacesofmeter.2. Makesurethetreatedarearemainswetforaminutetoeffectivelykillblood‐bornepathogens.3. Ensurethetreatedareaarethoroughlydry.4. Discardthewipesandachieveacleaning/disinfectioncycle.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A18of2620. ErrorandWarningmessageErrormessagesandtrouble‐shootingtipswillbedisplayedonthescreen.PleasepayattentiontotheerrormessagesandinformationtomakesurethePixoTestPOCTSystemisperformingaccurately.Thefollowingtablelistserrormessageandtroubleshootingtips,whichmayappearonthescreenduringperformingthesystem.Errormessage–A1cErrorNumberErrorMessageProblemCauseWhattoDoNote01MeasurementFailureThemeasurementisinterruptedduetoimproperoperation.Pleasekeeptheteststripstabilizedanddon’tmovetheteststripduringmeasurement.Ifthiserrorstillhappensonbloodsampleswithnormalrangeoftotalhemoglobin,pleasecontactyoursystemprovider.Note02SystemTiltItisdetectedthatthetiltsduringmeasurement.PleasekeepthePOC‐X01flatandstabilizedonatableduringmeasurement.Note03Out‐of‐rangeTemperat u reTheambienttemperatureisoutsidetherecommendedoperatingtemperaturerange.Performatestinanenvironmentwiththetemperaturebetween15‐32°C(59‐89.6°F).DonotheatorcoolyourPOC‐X01.Note04BloodSampleErrorNosampleorinsufficientsamplevolumeappliedontheteststripwasdetectedafterthesystemindicatestoapplythebloodsample.Discardthisteststripandre‐testwithanewtestkit.Note05TestStripErrorInvalidteststriporimproperinstallationoftheteststripwasdetectedduringmeasurement.Reinstallanewtestkitproperlyandtestagain.Note06CalibrationErrorIncompleteorincorrectcalibrationprocesswasdetected.InsertonlytheCalibrationCardprovidedbythemanufacturerandswitchtheItemselectionkeytotheA1cmodeforthecalibration.DoNotmovetheCalibrationCardduringcalibration.Note07SystemErrorAbnormalsignalscomingfromhardwareproblemsweredetectedDothecalibrationagainandiftheerrorstillpersists,please
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A19of26duringcalibrationprocess.contactyoursystemprovider.Errormessage–LipidErrorNumberErrorMessageProblemCauseWhattoDoNote01MeasurementFailureThemeasurementisinterruptedduetoimproperoperation.Pleasekeeptheteststripstabilizedanddon’tmovetheteststripduringmeasurement.Note02LightSignalErrorThemeasurementisinterruptedduetothestrongstraylightinthestripmodule.Pleasemakesurethatthestripmoduleissecurelyattachedandtheslidingdoorisclosedcompletely.Note03Out‐of‐rangeTemperat u reTheambienttemperatureisoutsidetherecommendedoperatingtemperaturerange.Performatestinanenvironmentwiththetemperaturebetween18‐32°C(64.4‐89.6°F).DonotheatorcoolyourPOC‐X01.Note04BloodSampleErrorNosampleorinsufficientsamplevolumeappliedontheteststripwasdetectedafterthesystemindicatestoapplythebloodsample.Discardthisteststripandre‐testwithanewtestkit.Note05TestStripErrorInvalidteststriporimproperinstallationoftheteststripwasdetectedduringmeasurement.Reinstallanewtestkitproperlyandtestagain.Note06CalibrationErrorIncompleteorincorrectcalibrationprocesswasdetected.InsertonlytheCalibrationCardprovidedbythemanufacturerandswitchtheItemselectionkeytotheA1cmodeforthecalibration.DoNotmovetheCalibrationCardduringcalibration.Note07SystemErrorAbnormalsignalscomingfromhardwareproblemsweredetectedduringcalibrationprocess.Dothecalibrationagainandiftheerrorstillpersists,pleasecontactyoursystemprovider.21.DisposalinformationDiscardtheusedteststripscarefully.Usedteststripsmaybeconsideredasbiohazardouswasteinyourarea.Handleanddisposeofallmaterialscomingincontactwithbloodaccordingtouniversalprecautionsandguidelines.Washyourhandswithsoapandwaterafterhandlingtheteststrip.
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A20of2622.ProductinformationSpecificationPOC‐X01AnalyzerDimension181mm(L)x111mm(W)x53mm(H)Weight131.3gPower5000mAhbattery,non‐removablestorage10000setsOperatingTemperat u re10℃~40℃(50℉~104℉)Humidity10%~90%RHOperationatmosphericpressurerange760mmHg~526mmHgStorage&Transportationcondition Temperature1℃~40℃(34℉~104℉)Humidity10%~90%RHCalibrationCardStoredinthepackagepouchandwith1yearsshelflifeothers• Indooruse• OvervoltagecategoryII• Pollutiondegrees2ChargerUSversionManufacture:DONGGUANAOHAIPOWERTECHNOLOGYCO.,LTD.Model:A18A‐050100U‐US2Input:100‐240V~50/60HzMax0.2AOutput:5V1.0AENversionManufacture:DONGGUANAOHAIPOWERTECHNOLOGYCO.,LTD.Model:A824A‐120150U‐EU1Input:100‐240V~50/60Hz0.5AOutput:5V2.0A/9V2A/12V1.5AUKversionManufacture:DONGGUANAOHAIPOWERTECHNOLOGYCO.,LTD.Model:A806‐050100U‐UK1Input:100‐240V~50/60Hz0.2AOutput:5V1.0A
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A21of26Test stripforLipidMeasuringRangeTC:100–450mg/dL,(2.59–11.64mmol/L)TG:45–650mg/dL,(0.51–7.34mmol/L)HDL:25–95mg/dL,(0.65–2.46mmol/L)SampleFreshcapillaryorvenouswholebloodSampleSize35µLTest Time3minutesHematocritTC/TG:30–55%;HDL:30–52%OperatingTemp eratureRange18–32°C(64–90°F)Test StripStorageTemperat ure 2–32°C(36–90°F)Shelf‐life18months*:Test stripmaybestoredinarefrigeratorat2–8°C(36‐46°F),butmustbebroughttoroomtemperaturebeforeuse.Test stripforA1cMeasuringRange4.0–15.0%SampleFreshcapillaryorvenouswholebloodSampleSize5µLTest Time3minutesHematocrit25–65%OperatingTemp eratureRange15–32°C(59‐90°F)Test StripStorageTemperat ure *1–30°C(34to86°F)Shelf‐life18months*:Test stripmaybestoredinarefrigeratorat2–8°C(36‐46°F),butmustbebroughttoroomtemperaturebeforeuse.23.LimitationsPixoTestA1cTestStrip1.Thebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem.2.DonotchargeyoursmartphonewhenyouusethePixoTextPOCTSystem.3.PixoTestPOCTSystemcanperformsinthehemoglobinarangeof7‐23g/dLandahematocritrangeof25to65%.4.PerformanceofPixoTestPOCTSystemhasnotbeentestedonsamplesfromnewborns.5.Cosmeticssuchashandcreamsorlotionsoftencontainglycerol.Useoftheseproductsmaycauseinaccurateresults.6.Forinvitrodiagnosticuseonly.7.PixoTestA1cTestStripisforsingleuse.8.Donotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriatelightenvironment.9.Strongelectromagneticfields(e.g.microwaveovens)mayaffectperformance.10.Interferences:Thefollowingsubstancesmaycausefalseresultsatlevelsofthebelow.Acetylsalicylic acid > 30 mg/dLAscorbic acid > 10 mg/dLAcetaminophenol > 30 mg/dLBillirubin > 20 mg/dLCaffeine > 30 mg/dLHydroxyzine Dihydrocholoride > 30 mg/dLTriglyceride > 900 mg/dLGlyburide > 20 mg/dLIbuprofen > 20 mg/dLDopamine > 2 mg/dLSubstances concentration (mg/dL)
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A22of26PixoTestLipidTestStrip1.Thebatterylifeneedstobeover20%beforeusingthePixoTestPOCTSystem.2.DonotchargePOC‐X01whenyouusethePixoTextPOCTSystem.3.Hematocritsof30to55%(TC/TG),30to52%(HDL)forLipidTestStripdonotaffectresults.4.PerformanceofPixoTestPOCTSystemhasnotbeentestedonsamplesfromnewborns.5.Cosmeticssuchashandcreamsorlotionsoftencontainglycerol.Useoftheseproductsmaycauseinaccurateresults.6.Forinvitrodiagnosticuseonly.7.Test stripisforsingleuse.8.Donotcarryoutthetestindirectsunlight.Themeasurementshouldbeperformedinanappropriatelightenvironment.9.Strongelectromagneticfields(e.g.microwaveovens)mayaffectperformance.10.Interferences:Thefollowingsubstancesmaycausefalseresultsatlevelsofthebelow.24.ManufactureriXensorCo.,Ltd.6F.,No.9,Aly.2,Ln.35,JihuRd.,NeihuDist.,TaipeiCity,11492,Taiwanwww.ixensor.comAuthorizedrepresentativeMDSSGmbHSchiffgraben4130175Hannover,Germany25.SymbolCataloguenumberSerialnumberoftheanalyzerConsultinstructionsforuseContainsSufficientfor<n>Test sAuthorizedrepresentativeintheEuropeanCommunityTemperat u relimitationManufacturerDateofManufactureBatchCodeIn‐vitrodiagnosticUseUsebydateCaution,ConsultaccompanyingdocumentsDonotreuse
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A23of2626.ServicingThePixoTestPOCTSystemsisintendedtoprovidesafeandreliableoperationaccordingtotheinstructionsprovidedbyiXensorCo.,Ltd.iXensorCo.,LtdrecommendsthatthePixoTestPOCTsystemcanbeinspectedandservicedbyauthorizedtechniciansifthereisanyconcernwithdevicefunction.Otherwise,serviceandinspectionofthedevicesgenerallyshouldnotberequiredifusedbyfollowingtheinstructionforuse.27.LimitedWarrantyiXensorCo.,Ltd(hereafter‘iXensor’)givesthecustomeralimitedmanufacturerwarrantyonneworiginaliXensorproductsandrelativeaccessoriesinaccordancewiththewarrantyconditionsapplicabletotheiteminquestionandinaccordancewiththewarrantyperiodsfrompurchasedate,pleaserefertothelistasbelow.Thiswarrantydoesnotcoverdamagecausedbyoperatorhimself,accident,misuse,abuse,alterationandotherdefectsnotrelatedtomaterialorworkmanship.Toexerciseyourrightsunderthiswarranty,pleasecontactyourlocal,authorizeddistributorsorservicecenter.ItemWarrantyperiodPixoTestPOCTAnalyzer1yearUSBCharger1yearPixoTestPOCTCalibrationCard1yearUSBTypeCChargeCableNoneOtherdisposablepartsNoneCustomerName:_______________________________________________________________________CustomerAddress:____________________________________________________________________Telephone:____________________________E‐mailaddress:_________________________________Dateofpurchase:_____________________________________________________Distributorinformation:
文件名稱 Instruction for Use Doc.No.文件編碼 CDM‐C01‐C3‐IFU‐POCX1‐ALL‐01表單編號：FT‐73‐01‐0008‐0007A 24of26Appendix1:Reference1. AmericanDiabetesAssociation,ClinicalPracticeRecommendationGuidelines2003,Diabetescare,Vol.26.Supplement1.p.222. Stedman,TL.Stedman’sMedicalDictionary,27thEdition,1999,p.2082.3. EllenT.Chen,JamesH.Nichols,Show‐HongDuh,GlenHortin,MD:DiabetesTechnology&Therapeutics,PerformanceEvaluationofBloodGlucoseMonitoringDevices,Oct2003,Vol.5,No.5:749‐7684. SiedelJ,HageleEO,ZiegenhormJ,WahlefeldAW.Reagentfortheenzymaticdeterminationofserumtotalcholesterolwithimprovedlipolyticefficiency.ClinChem1983;29:1075‐80.5. ExpertPanelonDetection,Evaluation,andTreatmentofHighCholesterolinAdults.ExecutivesummaryoftheThirdReportoftheNationalCholesterolEducationProgram(NCEP)ExpertPanelonDetection,Evaluation,andTreatmentofHighCholesterolinAdults(AdultTreatmentPanelIII).JAMA2001;285:2486‐97.6. IDFClinicalGuidelinesTaskForce.GlobalguidelineforType2diabetes.Brussels;InternationalDiabetesFederation,2005.7. Definitionanddiagnosisofdiabetesmellitusandintermediatehyperglycemia:reportofaWHO/IDFconsultation.WHO,Geneva2006(ISBN9241594934,ISBN9789841597936).8. D’Orazioetal.:“ApprovedIFCCRecommendationofReportingResultsforBloodGlucose(Abbreviated);”ClinicalChemistry51:91573‐1576‐(2005).9. AmericanDiabetesAssociation,PositionStatement,DiagnosisandClassificationofDiabetesMellitus,DiabetesCare35:S4‐S10,2012.10. AmericanDiabetesAssociation:ClinicalPracticeRecommendations(2013)DiabetesCare,Vol36,Supplement1,p.S1‐S100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 StatementThis 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

Navigation menu