iXensor POC-X01 PixoTest POCT Analyzer User Manual

iXensor Co. Ltd. PixoTest POCT Analyzer Users Manual

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POC X01 User Manual HTML Version

Users Manual

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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

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InstructionsforUse

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PixoTestPointofCareTest

(POCT)System

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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

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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

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Appendix1:Reference……………………………………………………………………………………………………………………………………..24

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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

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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

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Fig.1FrontsightofPixoTestPOCTAnalyzer(POC‐X01)

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Fig.2BacksightofPixoTestPOCTAnalyzer(POC‐X01)

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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:

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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

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ADisplay

Showsatestresult,messages,andthetestresults

storedinmemory.

BSlidingDoor

Opentoapplysample.

CItemSelectionKey

Selectmeasurementmode.

D PowerKey

PresstoturnanalyzerONorOFF.

EUSBChargePort

Chargetheanalyzer.

FProtectionCover

Removetoclean.

GLipidTestStripSlot

Insertalipidteststriphere.

HA1cTestStripSlot

InsertA1cteststriphere.

IStripModule

JStripModuleLockSwitch

Unlocktochangethestripmodule.

KCameraModule

ScanQRcode

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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

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PixoTestPOCTLipidTestStrip(usewithPixoTestPOCTAnalyzer):

• 25PixoTestLipidTestStrips(fordifferentpackage)

• 1packageinsert

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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

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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blood

SampleSize35µL

Test Time3minutes

Hematocrit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blood

SampleSize5µL

Test Time3minutes

Hematocrit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/dL

Ascorbic acid > 10 mg/dL

Acetaminophenol > 30 mg/dL

Billirubin > 20 mg/dL

Caffeine > 30 mg/dL

Hydroxyzine Dihydrocholoride > 30 mg/dL

Triglyceride > 900 mg/dL

Glyburide > 20 mg/dL

Ibuprofen > 20 mg/dL

Dopamine > 2 mg/dL

Substances 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 I

struction 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total

cholesterol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of

the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Diabetes

Federation,2005.

7. Definitionanddiagnosisofdiabetesmellitusandintermediatehyperglycemia:reportofaWHO/IDF

consultation.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 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

iXensor POC-X01 PixoTest POCT Analyzer User Manual

iXensor Co. Ltd. PixoTest POCT Analyzer Users Manual

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