Bioland Technology BGMB001 Blood Glucose Monitoring System User Manual G 427B x

Bioland Technology Ltd. Blood Glucose Monitoring System G 427B x

G-427B user manual

Bioland® Blood Glucose Monitor Model：G-427B OWNER'S MANUAL 
1/19Dear Bioland Blood Glucose Monitoring System Owner: Thankyouforchoosingthissystem!Thismanualcontainsimportantinformationyoumustknowaboutthesystem.Pleasereaditthoroughlyandcarefully.ThesystemprovidesNoCodefunctionwhichmeansthatyoudon'tneedtocalibrateyourmetermakingiteasierfortheusertomonitorbloodglucoseathome.IMPORTANT SAFETY INSTRUCTIONS Themeterandlancingdeviceareforsinglepatientuse.Donotsharethemwithanyoneincludingotherfamilymember!Donotuseonmultiplepatients!AlIpartsofthekitareconsideredbiohazardousandcanpotentiallytransmitinfectiousdiseasesevenafteryouhaveperformedcleaninganddisinfection.Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipment.ThisdevicecomplieswithPart15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.ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,usesandcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:‐‐Reorientorrelocatethereceivingantenna.‐‐Increasetheseparationbetweentheequipmentandreceiver.‐‐Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected.‐‐Consultthedealeroranexperiencedradio/TVtechnicianforhelp.READ THIS BEFORE USING DANGER‐Misuseofthiselectricaldevicecancauseelectrocution,burns,fireandotherHAZARDS.Basicsafetyprecautionsshouldalwaysbetaken,includingallthoselistedbelow.Closesupervisionisnecessarywhenequipmentisusedby,on,ornearchildren,
2/19handicappedpersonsorinvalids.Thefollowingbasicsafetynoticeshouldalwaysbetaken:1.Donotplacethedeviceinliquid,norputitwhereitcouldfallintoliquid.2.Thefollowingbasicsafetynoticeshouldalwaysbetaken.3.Usethedeviceonlyfortheintendedusedescribedinthismanual.4.Donotuseadjunctwhicharenotsuppliedbytheproducer.5.Donotmakethedevicecomeintocontactwithsurfaceswhicharetoohottotouch.6.Donotusethedevicewhereaerosolspraysarebeingused.7.Donotusethedeviceifitisnotworkingproperly,orifithasbeendamaged.8.Readallthemanual,andpracticethetest,andthenusetheproducttotestyourbloodglucose.Doallqualitycontrolchecksasdirectedandconsultwithadiabetesexpert.KEEPTHESEINSTRUCTIONINASAFEPLACE
3/19Table of Contents BEFOREYOURBEGIN.........................................................................................................................4INTRODUCTIONTOTHESYSTEM.......................................................................................................4IntendedUse.............................................................................................................................4ABOUTALTERNATIVESITETESTING(AST).........................................................................................5CONTENTSOFTHEKITS.....................................................................................................................6BloodGlucoseMeter.................................................................................................................7MeterScreenDisplayMessage.................................................................................................7TestStrip....................................................................................................................................7SETTINGTHEMETERANDDELETINGTHEMEMORY........................................................................8THETWOMEASURINGMODES.......................................................................................................11TESTINGWITHBLOODSAMPLE......................................................................................................11OverviewoftheLancingDevice..............................................................................................12SettingUptheLancingDevice.................................................................................................12Preparingthepuncturesite....................................................................................................13PerformingaBloodGlucoseTest ............................................................................................13ComparingMeterandLaboratoryResults..............................................................................15CONTROLSOLUTIONTEST...............................................................................................................15VIEWINGRESULTSONTHEMETER.................................................................................................16CAREANDSTORAGEFORYOURSYSTEM........................................................................................17CleaningandDisinfection........................................................................................................17METERSPECIFICATION....................................................................................................................18Limitationsofuse:...................................................................................................................18DISPLAYMESSAGE...........................................................................................................................19Problems.................................................................................................................................20
4/19BEFOREYOURBEGINInstallingthebattery1.Openthebatterycoveronthebackofmeter.2.Ifreplacingthebatteries,pleaseremovetheusedbatteries.3.Insert2new(AAA)batterieswithcorrect+/‐direction.4.Closethebatterycover.EnvironmentProtection–Wasteelectricalproductsshouldnotbedisposedofwithhouseholdwaste.Pleaserecyclewherefacilitiesexist.CheckwithyourlocalAuthorityorretailerforrecyclingadvice.INTRODUCTIONTOTHESYSTEMIndicationsforUseTheBloodGlucoseMonitoringSystemisintendedtobeusedforthequantitativemeasurementofglucose(sugar)infreshcapillarywholebloodsamplesdrawnfromthefingertip.TheBloodGlucoseMonitoringSystemisintendedtobeusedbyasinglepatientandshouldnotbeshared.TheBloodGlucoseMonitoringSystemisintendedforself‐testingoutsidethebody(invitrodiagnosticuse)bypeoplewithdiabetesathomeasanaidtomonitortheeffectivenessofdiabetescontrol.TheBloodGlucoseMonitoringSystemisnottobeusedforthediagnosisoforscreeningofdiabetes,orforneonataluse.TheTestStripsareforusewiththeBloodGlucoseMetertoquantitativelymeasureglucosedrawnfromthefingertips.Caution Thesystemisintendedforuseoutsidethebody(invitrodiagnosticuse).Itisforsingle‐patientuse.Itshouldbeusedonlyfortestingglucose(sugar)andonlywithfreshcapillarywholebloodsamplestakenfromthefingerandthealternativesitesincludingthepalm,theforearm,theupperarm,thecalfandthethigh.Thesystemisintendedforuseathome.Itshouldnotbeusedforthediagnosisofdiabetesorforthetestingofnewborns. TheSystemistobeusedbyasinglepersonandshouldnotbeshared. TheSystemisintendedforself‐testingoutsidethebody(invitrodiagnosticuse)by
5/19peoplewithdiabetesathomeasanaidtomonitortheeffectivenessofdiabetescontrol.Alternativesitetestingshouldbedoneonlyduringsteady–statetimes(whenglucoseisnotchangingrapidly). The“Bioland”TestStripsareforusewiththeBloodGlucoseMetertoquantitativelymeasureglucoseinfreshcapillarywholebloodsamplesdrawnfromthefingertips,palm,forearm,upperarm,calfandthigh. TheBiolandcontrolsolutionsisintendedforusewiththeSystem,tocheckthattheglucosemeterandteststripsareworkingproperlyandthatyouaredoingthetestcorrectly.Thesesolutionscontainaknownrangeofglucose,asindicatedonthestripsvialbottles. Thisdeviceisnotintendedforuseinhealthcareorassisted‐usesettingssuchashospitals,physician’soffices,orlong‐termcarefacilitiesbecauseithasnotbeendeterminedtobesafeandeffectiveforuseinthesesettings,includingforroutineassistedtestingoraspartofglycemiccontrolprocedures. UseofthisdeviceonmultiplepatientsmayleadtotransmissionofHumanImmunodeficiencyVirus(HIV),HepatitisCVirus(HCV),HepatitisBVirus(HBV),orotherbloodbornepathogens.ASTinthissystemcanbeusedonlyduringsteady‐statebloodglucoseconditionsdescribedinthesectionof“AboutAST”.TestprincipleThetestisbasedonthemeasurementofelectricalcurrentgeneratedbythereactionofglucosewiththereagentofthestrip.Themetermeasuresthecurrentanddisplaysthecorrespondingbloodglucoselevel.Thestrengthofthecurrentproducedbythereactiondependsontheamountofglucoseinthebloodsample. ABOUTALTERNATIVESITETESTING(AST)Important.TherearelimitationsfordoingAST.PleaseconsultyourhealthcareprofessionalbeforeyoudoAST.WhatisAST?Alternativesitetesting(AST)meansthatpeopleusepartsofthebodyotherthanthefingertipstochecktheirbloodglucoselevels.Thissystemallowsyoutotestonthepalm,theforearm，theupperarm,thecalf，orthethighwiththeequivalentresultstofingertipstesting.What’stheadvantage?Fingertipsfeelpainmorereadilybecausetheyarefullofnerveendings(receptors).Atotherbodysites,sincenerveendingsarenotsocondensed,youwillnotfeelasmuchpainasatthefingertip.
6/19WhentouseAST?Food,medication,illness,stressandexercisecanaffectbloodglucoselevels.Capillarybloodatfingertipreflectsthesechangesfasterthancapillarybloodatothersites.Thereforewhentestingbloodglucoseduringorimmediatelyaftermeal,physicalexercise,oranyotherevent,takeabloodsamplefromyourfingeronly.YoudoASTonlyinthefollowinginstances: Inapre‐mealorfastingstate(morethan2hourssincethelastmeal). Twohoursormoreaftertakinginsulin. Twohoursormoreafterexercising.NOTE: Alternativesitetesting(AST)shouldnotbeusedtocalibratecontinuousglucosemonitoringsystems(CGMs). Resultsfromalternativesitetestingshouldnotbeusedininsulindosescalculations.DoNOTuseASTif: Youthinkyourbloodglucoseislow. Youareunawareofhypoglycemia. Youaretestingforhyperglycemia. YourASTresultsdonotmatchthewayyoufeel. Yourroutineglucoseresultsareoftenfluctuating.CONTENTSOFTHEKITS AMeter CarryCase Owner’sManual TwoAAAAlkalineBatteries TestStrips(Optional) LancingDevice SterileLancet(Optional) ControlSolution(Optional)NOTE: TheLancingDevicecanbeusedforseveraltimeshoweverthelancetshouldbechangedaftereachuse. Sterilelancetandcontrolsolutionarenotincludedinthestandardkit. Therearethreelevelsforthecontrolsolutions:low,normalandhighavailable,pleasecontacttheplaceofpurchaseformoreinformation. Ifanyitemsaremissingfromyourkitoropenedpriortouse,pleasecontactlocalcustomerservicesorplaceofpurchaseforassistance.
7/19BloodGlucoseMeter1.STRIPPORT：Whereyouinserttheteststrip.Themeterwillturnonautomatically2.DATAPORT：Locatedatthesideisforcableconnection3.STRIPEJECTOR：Slideforwardtoejecttheteststripaftertest4.LCDDISPLAY：Itguidesyouthroughthetestusingsymbolsandsimplemessages5."M"BUTTON：Itisusedtoturnonthemeterenterthememorymode6."S"BUTTON：ItisusedtosetupthemeterMeterScreenDisplayMessage1) BLOODDROPSYMBOL:Flasheswhenitisreadytoapplythebloodsample2) TESTSTRIPSSYMBOL:Appearswhenthemeteristurnedon3) LOWBATTERYSYMBOL:Appearswhenthebatterypowerislow4) MEASUREMENTUNIT:Appearswiththetestresultinmg/Mlormmol/L5) CTLSYMBOL:AppearswhendoingaControltestandindicatesThattheresultwon/tbeStoredinthememory6) MEMORYSYMBOL:Appearswhenyoureviewthememory7) TESTRESULTAREA:Displaysglucoseresults8) KETONEWARNING:Appearswhenyourresult≧13.3mmol/L(240mg/dl)9) BLUETOOTHSYMBOL:Appearswhentransmitdata10) DATE11) DAYAVERAGE:Indicatethatthedisplayedtestresultisanaveragevalue12) TIMETestStripEachstripcanbeusedonlyonce.Theteststripconsistsofthefollowingparts:1‐AbsorbentholeApplyadropofbloodhere.Thebloodwillbedrawninautomatically.
8/192‐ConfirmationwindowThisiswhereyouconfirmifenoughbloodhasbeendrawnintotheabsorbentholeofthestrip.3‐TeststriphandleHoldthisparttoinserttheteststripintotheslot.4‐ContactbarsInsertthisendoftheteststripintothemeter.Pushitinfirmlyuntilitwillgonofurther.Attention!TestresultsmightbewrongifthecontactBarisnotfullyinsertedintothetestslot.Thefrontsideoftheteststripshouldfaceupwheninsertingtheteststrip.SETTINGTHEMETERANDDELETINGTHEMEMORY 1.Settingthelanguageandvoicevolume1.1SettingthelanguagePressandHold“S”buttonfor3seconds,untiltheENGorESPisflashing.Press“M”buttontoselectalanguageyoudesire.Press“S”.1.2SettingtheVolumeWiththeVolumelevelnumberflashing,Press“M”buttontoselectlevelbetween“0”~”7”(set“0”toturnedoffvoice).Press“S”.2.Settingthedateandtime2.1SettingtheYearPressandHold“S”buttonfor3seconds,untilthelasttwodigitsoftheyearwillflashonthescreen(forexample,“14”equals2014).Press“M”buttonuntilthecorrectyearappears.Press“S”.2.2SettingthemonthWiththemonthflashing,press“M”untilthecorrectmonthappears.Press“S”.
9/192.3SettingthedayWiththedayflashing,Press“M”untilthecorrectdayappears.Press“S”.2.4SettingtheAM/PMWiththeAMorPMflashing,Press“M”untilthecorrectoneappears.Press“S”.2.5SettingthehourWiththehourflashing,Press“M”untilthecorrecthourappears.PressS“.2.6SettingtheminuteWiththeminuteflashing,Press“M”untilthecorrectminuteappears.Press“S”.3.DeletingtheMemoryPress“S”then“dEL”willdisplaywithflashing“M”.Press“M”once,toconfirmdelete,press“M“buttonagaintodeleteALLmemory.Themeterthendisplays“OK”,whichmeansthatthememoryisdeleted.Ifyoudon’twanttodeletethememory,presstheSbuttontoskipthisstep.Themeterwillautomaticallyturn“OFF”,andthesetupwillbecompleted.NOTE: Thedate,time,unitandmemorydeletioncanONLYbesetinthesettingmode. Whenthemeterisinsettingmode,ifnobuttonispressedwithin3minutes,themeterwillturnoff. Nosetupnecessary,meterispre‐set.Meterispre‐setforEasternStandardTime.Pleaserefertopage13ofthismanualforsetupinstruction.4.SpeakingFunctionCleverChoiceVoiceHDmeter“speaks”withstepbystepinstructionstoguideyouthroughtheprocessofsettingupyourmeterandbloodglucosetesting.Thefollowingtabletellsyouwhenandwhatthemeter“speaks”/Whendoesthemeterspeak?Whatdoesthemeterspeak?SettingupthemeterChoosingthelanguageSettingmode,thankyouforusingthis
10/19product.SettingthevoicevolumeVoicevolumeis(number)SettingtheyearTheyearis(number)SettingthemonthThemonthis(month)SettingthedateThedateisthe(number)SettingtheAM/PMAM/PMSettingthehourThehouris(number)SettingtheminutesTheminutesare(number)Deletingthememory1.Deleteallrecordmode.Press“M”keytodeleteallrecords.2.Areyousure?Yes,topress“M”keyagain.3.Allmemoryrecordhavebeendeleted.Attheendofthemetersetting1.Tod ay ’sdateis(month)(day),(year)2.Thetimeis(hourminute)AM/PM3.ThankyouforusingthisproductUsingthemeterInsertteststripWhenthemeterisreadytotest.1.Teststripinserted2.Today ’sdateis(month)(day),(year)3.Thetimeis(hourminute)AM/PM4.Pleaseapplybloodontotheteststrip.AftersampleisappliedontotheteststripBeepWhenthetestiscompleted(resultappearsondisplay)Yourbloodglucoseis(number)milligramsperdeciliterWhenthetestresultis＜20mg/dLYourbloodglucoseislessthan20milligramsperdeciliterWhenthetestresultis＞600mg/dLYourbloodglucoseisover600milligramsperdeciliterWhenselectedCTLforcontrolsolutiontestingControlsolutionmodeRecallthestoredtestresult(pressMkeytoturnon)1.Today ’sdateis(month)(day),(year)2.Thetimeis(hourminute)AM/PM3.PressMkeyformemoryrecallmode4.Memoryrecordfor(month)(day),(year)(hourminute)AM/PM5.Yourbloodglucosewas(number)milligramsperdeciliterRecalltheaverageofbloodglucoseresultsThe(number)daybloodglucoseaverageis(number)milligramsperdeciliterfor(number)recordsIfnoresultsstoredinmemoryNomemoryrecordavailableDownloadingresultsfromyourmeterontothecomputerConnectingcomputerWhendisplayE‐bThebatteryisdead,pleasereplace
11/19WheninsertedanusedstripStriphasbeenusedWhenroomtemperatureisoutsideoperatingrange,whichis50℉~104℉(10℃~40℃)TemperatureisoutofrangeWhenerrormessageappearUnabletomeasureTHETWOMEASURINGMODESThemeterprovidesyouwithtwomodesformeasuring,GeneralandCTL.TheCTLmodeshouldbeusedwhenacontrolsolutionisbeingtested.Seethetablebelow.ModesUsewhenGeneraltest(notdisplay)AnytimeofdaywithoutregardtotimesincelastmealCTLTestingwiththecontrolsolutionYoucanswitchbetweeneachmodeby:1.Startwiththemeterturnedoff.Insertateststriptoturnonthemeter,thescreenwilldisplayaflashingblooddrop. 2.PressMtoselectGeneralorCTLmode.TESTINGWITHBLOODSAMPLECAUTION:Toreducethechancesofinfection: Chooseaclean,dryworksurface. Neversharealancingdeviceandlancetwithanotherperson. Alwaysuseanewandsterilelancet.Lancetsareforsingleuseonly. Alwaysuseanewteststrip.Teststripareforsingleuseonly. Avoidgettinglotion,oils,dirtordebrisinoronthelancetandlancingdevice.Note:Beforetesting,pleasereadthefollowingstepsthoroughlyandcarefully,pleaserelaxanddotheteststepbystep.Simplifyingorchangingthetestproceduremayproduceinaccurateresults.
12/19OverviewoftheLancingDeviceA.DeviceCapB.HandleC.NeedleCapD.NeedleHolderE.DeviceBodyF.ConnectingCollarG.AdjustabletipH.ReleaseButtonI.EjectionButtonJ.DevicecontrolcapOnthelancetsandthelancingdevice.Ifyourlancingdevicediffersfromtheoneshownhere,pleaserefertothemanufacturer’smanualtoensureproperusage.NOTE:Toreducethechanceofinfection:●Neversharealancetorthelancingdevice.●Alwaysuseanew,sterilelancet.Lancetsareforsingleuseonly.●Avoidgenghandloon,oils,dirt,ordebriswhenhandlingthelancets.SettingUptheLancingDevice1.Screwthelancingdevicecapoff.Insertaneedleintothelancetholderandpushdownfirmlyuntilitisfullyinplace.2.Screwtheneedlecapandplaceitinappropriatelocationtouseagainafterfinishblood‐taking.3.Replacethelancingdevicecap.Turnthecapuntilitissnugbutnottootight.AndthenAdjusttheadjustabletiptoproperlevel.NOTE:Theadjustabletipoffers5levelsofskinpenetration.Twisttheadjustabletiptotheproperlevel:1‐2levelforsoftorthinskin3levelforaverageskin4‐5levelforthickorcallousedskin
13/194.Pullthedevicecontrolcapuntilitclicks.Ifnotclicks,checktheneedleisinstalledappropriately.5.Aimingatthesterilizedpartforblood‐taking,pressthereleasekeytofinishblood‐taking.6.Screwthedevicecap.Pushtheexposedneedleintotheneedlecap,andthenpushtheejectionbuttontodiscardtheusedneedleinappropriatecontainer.Coverthedevicecapatlast.PreparingthepuncturesiteStimulatingbloodperfusionbyrubbingthepuncturesitepriortobloodextractionhasasignificantinfluenceontheglucosevalueobtained.Bloodfromasitethathasnotbeenrubbedexhibitsameasurablydifferentglucoseconcentrationthanbloodfromthefinger.Whenthepuncturesitewasrubbedpriortobloodextraction,thedifferencewassignificantlyreduced.Pleasefollowthesuggestionsbelowbeforeobtainingadropofblood: Rubthepuncturesiteforabout20secondsbeforepenetration. Selectthepuncturesiteeitheratthefingertipsoranotherbodypart(pleaseseesection“AlternativeSiteTesting ”(AST)onhowtoselecttheappropriatesites). Cleanthepuncturesiteusingcottonmoistenedwith70%alcoholandletitairdry.FingertiptestingHoldthelancingdevicefirmlyagainstthesideofyourfinger.Pressthereleasekey.Youwillhearaclick,indicatingthatthepunctureiscomplete.NOTE： Chooseadifferentspoteachtimeyoutest.Repeatedpuncturesatthesamespotmaycausesorenessandcalluses. PleaseconsultyourhealthcareprofessionalbeforeyoubeginAST. Itisrecommendedtodiscardthefirstdropofbloodasitmightcontaintissuefluid,whichmayaffectthetestresult.PerformingaBloodGlucoseTestStep1.Washhandswithsoapandwarmwater.
14/19Step2.Removeateststripfromitsvial.Withclean,dryhands,youmaytouchtheteststripanywhereonitssurface.Donotbend,cutormodifytheteststripsinanyway.Removetheteststripfromthevialanduseitinstantly.Step3.Inserttheteststripintothemeter'stestportandthemeteristurnedon.Thetimeanddateappearsonthescreen.NOTE:Besuretouse“Bioland”teststrips,otherteststripsmaynotproduceaccurateresults.Step4Whentheblooddropsymbolflashesonthescreen,youmayselecttheappropriatemeasurementmode,forselectingthemeasurementmodeofControl(CTL)orGeneral,pleaserefertothe“THETWOMEASURINGMODES”section.Step5Applyyourbloodtotheabsorbentholeoftheteststrip.Step6Assoonasenoughbloodhasfilledtheconfirmationwindowoftheteststrip,youwillhearabeeplettingyouknowthetesthasbegun.Acountdownof5secondsstarts.Note:makesuretheconfirmationwindowoftheTestStripiscompletelyfilledwithyourbloodsample.Step7Yourbloodglucoselevel,alongdateandtimeappearsonthedisplay.Bloodglucoseresultsareautomaticallystoredinthememory. When bluetooth connected, Bluetooth symbol flashing, and waiting for other device with Bluetooth to scan and connect, then upload the test results data.NOTE:Theresultsobtainedfromthismeterareplasma‐calibrated.Thishelpsyouandyourphysicianorotherqualifiedhealthcareprovidertocompareyourmeterresultswithlaboratorytests.Referencetotheinstructionsgivenbyyourphysicianorotherqualifiedhealthcareprovider,donotdeviatefromtheseinstructionsonthebasisoftheresultwithoutfirstconsultingyourphysician.
15/19Step8Ejecttheusedteststripandremovethelancet.Toejecttheteststrip,pointthestripatadisposalcontainerforsharpobjects.Themeterwillswitchitselfoffautomaticallyaftertheteststripisejected.Pleasewashhandsthoroughlywithsoapandwaterafterhandlingthemeter,lancingdevice,orteststrips.Referencevalue:TimeofdayNormalplasmaglucoserangforpeoplewithoutBeforebreakfast(fasting)<100mg/dLTwohoursaftermeals<140mg/dLSource:AmericanDiabetesAssociation.StandardsofMedicalCareinDiabetes‐2012.DiabetesCare2012,35（Suppl.1)S11‐S63.Pleaseworkwithyourdoctortodetermineatargetrangethatworksbestforyou.ComparingMeterandLaboratoryResultsThemeterprovidesyouwithwholebloodequivalentresults.Theresultyouobtainfromyourmetermaydiffersomewhatfromyourlaboratoryresultduetonormalvariation.Meterresultscanbeaffectedbyfactorsandconditionsthatdonotaffectlaboratoryresultsinthesameway.Tomakeanaccuratecomparisonbetweenmeterandlaboratoryresults,followtheguidelinesbelow.Beforegoingtothelab:■Doacontrolsoluontesttomakesurethatthemeterisworkingproperly.■Fastforatleasteighthoursandthendocomparisontests,ifpossible.■Takeyourmeterwithyoutothelab.Whilestayingatthelab:Makesurethatthesamplesforbothtestsaretakenandtestedwithin15minutesofeachother.■Washyourhandsandthenobtainabloodsample■Neveruseyourmeterwithbloodthathasbeencollectedinagraytoptesttube.■Usefreshcapillarybloodonly.CONTROLSOLUTIONTESTMaterialneeded:●GlucoseMeter●Teststrips●ControlsoluonWhentodoacontrolsolutiontest:◆Whenyoususpectthatthemeterorteststripsarenotworkingproperly.
16/19◆Ifyourbloodglucosetestresultsarenotconsistentwithhowyoufeel.◆Aftertheteststripsareexposedtoextremeconditions.◆Afterdroppingthemeter.Thecontrolsolutionistocheckthatthemeterandtheteststripscanworktogetherasasystemandworkcorrectly.Step1Inserttheteststriptoturnonthemeter.Inserttheteststripintothemeter.Waitforthemetertodisplaythedropsymbol.Step2Youmaypress“M”buttontoselectCTLmode,forselectingtheCTLmode,pleaserefertothe“THETWOMEASURINGMODES”section.Step3ApplythecontrolsolutionShakethecontrolsolutionvialthoroughlybeforeuse.Squeezeoutadropandwipeitoff,thensqueezeanotherdropandplaceitonthetipofthevialcap.Holdthemetertomovetheabsorbentholeofteststripsoittouchesthedrop.Oncetheconfirmationwindowfillscompletely,themeterwillbegincountingdown.Toavoidcontaminatingthecontrolsolution,donotdirectlyapplycontrolsolutionontoastrip.Step4Theresultofthecontrolsolutionstestappearsonthedisplay.TheresultwillnotbestoredunderCTLmode.Theresultofthecontrolsolutionstestshouldbewithintherangeprintedontheteststripviallabel.Ifthetestresultsfallsoutsidethespecifiedrangeprintedonteststripviallabel,repeatthetest.Resultsfallingoutsidethespecifiedrangemaybecausedby:■Errorinperformingthetest■ExpiredorcontaminatedControlSoluon■ExpiredorcontaminatedTestStrip■MalfunconofyourMeterIfyoucontinuetogetcontrolsolutiontestresultsthatfalloutsideoftherangeprintedonthevial,thesystemmaynotbeworkingproperly,Donotusethemeter.PleasecontactyourcustomersupportimmediatelyNOTE:Donotusetheexpiredcontrolsolution.VIEWINGRESULTSONTHEMETERYourmeterstoresthe500mostrecentbloodglucosetestresultswithdatesandtimes.Italsoprovides7‐,14‐,21‐,28‐,60‐and90‐dayaveragesofyourbloodglucosetestresults.Note:Thecontrolsolutionreadingsarenotincludedintheaverageofyourresults.RecallingtheStoredTestResults
17/191.Startwiththemeteroff,pressthe“M”buttontoturnonthemeter.The“”symbolwillflashwiththetimeanddatedisplayedonthescreen.2.Press“M”again,themostrecenttestresultswithdateandtimewilldisplay.Press“M”oncemoreandthenextmostrecenttestresultswillappear.Eachtimeyoupressandrelease“M”,themeterwillrecalluptoyourlast500testresultsinorder.Pressthe“S”toturnoffthemeter.Whenthememoryisfull,theoldestresultisdroppedandthenewestresultisadded.ReadingtheAverageofBloodGlucoseResultsWhenthemeterisoff,pressandholdthe“M”buttonuntiltheDAYAVGflashing,releasebuttonthen7‐dayaverageresultsappearwith“n024”(means24recordstobeaveraged)onthescreen.Pressthe“M”buttontoreviewthe14‐,21‐,28‐,60‐and90‐daygeneralaverages.Pressthe“S”buttontoturnoffthemeter.Note:Thecontrolsolutionreadingsarenotincludedintheaverageofyourresults.CAREANDSTORAGEFORYOURSYSTEM◆Handlethemeterwithcare.Droppingorthrowingthemetermaycausedamagetothedevice.◆Don'texposetheBloodGlucoseMonitoringSystem,Teststrip,andControlSolution,toextremeconditions,suchashighhumidity,heat,freezingcoldordust.Thestorageconditionsfortheteststripsare39℉~86℉,Humidity＜80%RH.Storageconditionsforthemeterare‐40℉~131℉,Humidity＜80%RH.◆AlwayswashyourhandswithsoapandwaterandrinseanddrycompletelybeforehandlingtheBloodGlucoseMonitoringsystemandTeststrip.◆UseCaviWipes(seebelow)tocleantheBloodGlucoseMonitoringSystem.◆Discardtheusedlancetintoacontainerforsharpobjects.CleaningandDisinfectionThecleaninganddisinfectionisabsolutelynecessaryforthetestprocedure,becausecleaningcaninsurethemeterworkswell(forexample,displaywillbecleartoseeaftercleaning);anddisinfectioncanavoidtheinfectiontoyouortotheotherpeople,andthecross‐infection.Westronglywarnthatthedeviceshouldbecleanedanddisinfectedfollowinguseoneverypatient.Andwesuggestyouusethefollowingproduct:CaviWipes(EPAregistrationnumber：46781‐8）.Youcanpurchasethisproductaccordingtothefollowinginformation:visitthewebsite:www.metrex.comorcontactMetrexat800‐841‐1428forproductortechnicalinformation.CaviWipesarealsoavailableatwww.amazon.comorviaaGooglesearch.
18/19Themeterforsingle‐patientuseandthelancingdevicesmaybecleaned5‐6timesperday(Test5‐6timeseveryday),sothemeterwillbecleanedanddisinfectabout11000cyclesthatincludecleaningsplusdisinfections(1cycle=1cleaning+1disinfection)duringits5yearslifecycle.1.Beforethetest,theusershouldcleanandwashhands.Ifyouareacaregiver,(notthepatient),pleaseusedisposablegloves.2.Aftertest,takeonewipetocleanthemeter’shousing,buttons,lens,mark,usbcoverandsupportblock,includingitsfrontandbackfor10secondsforcleaninguntilthereisnosoilonthesurface.Thendisinfectthemeter’shousing,buttons,lens,mark,usbcoverandsupportblockuseanotherwipefor2min,keepthesurfacewetfor2min.3.Takeofftheglove;discardcarefullyaccordingtoyourhealth‐careprovider’sinstruction.Note:1.Eachdisinfectionsteprequiresapre‐cleaningstep.2.Ifthemeterisbeingoperatedbyasecondpersonwhoisprovidingtestingassistancetotheuser,themeterandlancingdeviceshallbecleanedanddisinfectedfirst.3.Theusersshouldwashhandsthoroughlywithsoapandwaterafterhandlingthemeter,lancingdevice,orteststrips.METERSPECIFICATIONModelG‐427B(with“Bioland”teststripandcontrolsolution)Machinesize90mm(L)×54mm(W)×13mm(H)Weight50g(excludingbatteries)MeasuringmethodAmperometrictechnologyusingglucoseoxidaseMeasuringrange20mg/dL~600mg/dLBloodSourceFreshcapillarywholebloodBloodVolumeAround1.8uLMemory448bloodglucosetestsDisplayLCDdisplaywithbacklightPowersourceDC3V(AAA×2alkalinebatteries)BatteryLifeApprox.500normaltestsOperatingconditions50℉~104℉,Humidity:25%~80%RHStorageCondition(system:meterandteststrips)39.2℉~104℉and below 85% relative humidityStorageCondition(meter)‐40℉~131℉,Humidity＜80%RH,700hPa~1060hPaUselifeFiveyearsLimitationsofuse:※ThebloodMonitoringSystemisnotintendedforuseonneonates.※ThebloodMonitoringSystemisnotintendedforuseonarteryblood,neonates’serumandplasma.
19/19※TheBloodGlucoseMetershouldbeusedwith“Bioland”teststrip.※Thesystemcanbeuseduptoanaltudeof10744feet.※Thefollowingsubstancesatlevelsgreaterthannormalortherapeuclevelsmaycausesignificantinterference(affecttheresultbygreaterthan10%)resultinginaninaccurateresult:ascorbicacid,uricacid,hemoglobin，acetaminophen,Dopamine,L‐dopa,L‐dopaandTolbutamideetc.Thesesub‐stancesdonotaffecttestresultsinnormalconcentrationbutmayaffecttestresultsinhighconcentration.Donotusehaemolysissample,icterussampleorhighlipemiasamples.※Thefollowingcompounds,whendeterminedtoinexcessoftheirlimitation,mayproduceinaccurateresults:Compound LimitationAscorbicacid ＞2mg/dLUricacid＞10mg/dLAcetaminophen ＞5mg/dLBilirubin＞15mg/dLDopamine＞0.03mg/dLL‐dopa＞0.45mg/dLMethyldopa＞0.75mg/dLTolbutamide ＞24mg/dLTriglycerides ＞2000mg/dLHemoglobin ＞250mg/dL※Paentsundergoingoxygentherapymayyieldfalselylowerresults.※Notforuseforpaentsinahyperglycemic‐hyperosmolarstate,withorwithoutketosis.※Notforuseoncriticallyillpatients.※Nottobeusedforpaentswhoaredehydrated,hypertensive,hypotensiveorinshock.※Verylow(lessthan20%)orveryhigh(morethan60%)redbloodcellcount(hematocrit)canleadtoincorrecttestresults.Ifyoudonotknowyourhemarocritlevel,pleaseconsultyourhealthcareprovider.DISPLAYMESSAGEMESSAGEWHATITMEANSACTIONBloodglucoselevelislowerthan20mg/dl(1.1mmol/L)Themessageindicatesverylowbloodsugar.Youshouldconsultwithyourhealthcareprofessional.Bloodglucoselevelishigherthan600mg/dl(33.3mmol/L)Thisindicatesseverhyperglycemia(highbloodglucose).Youshouldseekimme‐diatemedicalassistance.
20/19MeterisreadytotestcontrolsolutionundertheCTLstate.Pleaseplaceadropofcontrolsolutionontothetestwellofteststrip.Batterypowerislow.Pleasechangethebattery.MESSAGEWHATITMEANSACTIONUseausedteststripPleaseuseanewstripandre‐testErrormassageindicatesthatyoumayremovethestripafeterapplyingbloodtotheabsorbentholeTryagainwithanewteststripProblemwiththemeterRe‐testwithanewteststrip.Iftheproblemisstillunsolved,pleasecallthecustomercarelineforhelp.Environmentaltemperatureislowerthan50℉~104℉Pleasetestatanenvironmentaltemperaturewithin50℉~104℉operationrangeProblemsProblemsCausesSolutionsDisplayremainsblankaftertheteststriphasbeeninsertedintotheMeter.1.Batterymaybeinstalledimproperly.2.Batterypoweristoolowforuse.3.ToomuchtimehaspassedbetweeninsertingtheTestStripandperfor‐mingthetest.44.TestStriphasnotbeenfullyinsertedintotheMeter.1.InstalltheBatterycorrectly.2.ReplacewithnewBattery.3.ReinserttheTestStripintotheMeter.4.ReinserttheTestStripintotheMeter.TestresultsareinconsistentorControlSolutiontestresultsarenotwithinthespecifiedrange.1.NotenoughsampleintheTestStrip.2.TestStriporControlSolutionhasexpired.3.TestStriphasbeendamagedduetoheatorhumiditysothatsamplecannotbeappliedorthespeedofapplyingsampleistooslow.44.Systemisnotper‐formingdue1.Redotestwithnewteststripandmakesurethatenoughsamplehasbeenadded.2.Redotestwithnewteststrip.3.PerformaControlSolutiontestusinganewTest Strip.Ifresultsarestilloutofrange,replacewithnewvialofTestStrips.4.BringSystemtoaroomtemperatureenvironmentand
21/19totheenvironmentbeingaboveorbelowroomtemperature.waitapproximately30minutesbeforeper‐forminganewtest.TheMeterco‐untdowndidnotstart.TestStriphasnotbeeninsertedcorrectly.UseanewTestStripandredothetest. Bioland Technology LTD. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong Road, Baolong Community Longgang District 518116, Shenzhen, Guangdong PEOPLE’S REPUBLIC OF CHINA Version: V1.0 @ 2016-01 by Bioland Technology LTD. 

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