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G-427B user manual | Users Manual | 510.35 KiB | ||||
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1 | G-427B user manual | Users Manual | 510.35 KiB |
Bioland Blood Glucose Monitor ModelG-427B OWNER'S MANUAL Dear Bioland Blood Glucose Monitoring System Owner:
Thank youforchoosing thissystem!
Thismanual contains important information youmustknowabout thesystem. Please read itthoroughly andcarefully. The systemprovides NoCodefunctionwhich meansthat you don't need tocalibrate your metermakingiteasierfortheusertomonitor blood glucose athome. IMPORTANT SAFETY INSTRUCTIONS Themeterandlancingdeviceare forsinglepatientuse.Donotsharethemwithanyone includingotherfamilymember!Donotuseonmultiplepatients!
AlI parts of the kit are considered biohazardous and can potentially transmit infectious diseasesevenafteryouhaveperformedcleaninganddisinfection. Changes or modifications not expressly approved by the party responsible for compliance couldvoidtheusersauthoritytooperatetheequipment. ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwo conditions: (1) this device may not cause harmful interference, and (2) this device must acceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation. This equipment has been tested and found to comply with the limits for a Class B digital device,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonable protectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates, uses and canradiate radio frequency energy and,ifnot installed andused in accordance with the instructions, may cause harmful interference to radio communications. However, thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation. Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcan bedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrect theinterferencebyoneormoreofthefollowingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiver isconnected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. READ THIS BEFORE USING DANGER Misuse of this electrical device can cause electrocution, burns, fire and other HAZARDS. Basicsafetyprecautions shouldalwaysbetaken,includingallthoselistedbelow. Close supervision is necessary when equipment is used by, on, or near children, 1/19 handicappedpersons orinvalids. Thefollowingbasicsafetynoticeshouldalwaysbetaken:
1.Donotplacethedeviceinliquid,norputitwhereitcouldfallintoliquid. 2.Thefollowingbasicsafetynoticeshouldalwaysbetaken. 3.Usethedeviceonlyfortheintendedusedescribedinthismanual. 4.Donotuseadjunctwhicharenotsuppliedbytheproducer. 5.Donotmakethedevicecomeintocontactwithsurfaceswhicharetoohottotouch. 6.Donotusethedevicewhereaerosolspraysarebeingused. 7.Donotusethedeviceifitisnotworkingproperly,orifithasbeendamaged. 8.Read all the manual, and practice the test, and then use the product to test your blood glucose.Doallqualitycontrolchecksasdirectedandconsultwithadiabetesexpert. KEEPTHESEINSTRUCTIONINASAFEPLACE 2/19 Table of Contents BEFOREYOURBEGIN.........................................................................................................................4 INTRODUCTIONTOTHESYSTEM.......................................................................................................4 IntendedUse.............................................................................................................................4 ABOUTALTERNATIVESITETESTING(AST).........................................................................................5 CONTENTSOFTHEKITS.....................................................................................................................6 BloodGlucoseMeter.................................................................................................................7 MeterScreenDisplayMessage.................................................................................................7 TestStrip....................................................................................................................................7 SETTINGTHEMETERANDDELETINGTHEMEMORY........................................................................8 THETWOMEASURINGMODES.......................................................................................................11 TESTINGWITHBLOODSAMPLE......................................................................................................11 OverviewoftheLancingDevice..............................................................................................12 SettingUptheLancingDevice.................................................................................................12 Preparingthepuncturesite....................................................................................................13 PerformingaBloodGlucoseTest............................................................................................13 ComparingMeterandLaboratoryResults..............................................................................15 CONTROLSOLUTIONTEST...............................................................................................................15 VIEWINGRESULTSONTHEMETER.................................................................................................16 CAREANDSTORAGEFORYOURSYSTEM........................................................................................17 CleaningandDisinfection........................................................................................................17 METERSPECIFICATION....................................................................................................................18 Limitationsofuse:...................................................................................................................18 DISPLAYMESSAGE...........................................................................................................................19 Problems.................................................................................................................................20 3/19 BEFOREYOURBEGIN Installingthebattery 1.Openthebatterycoveronthebackofmeter. 2. If replacing the batteries, please remove the used batteries. 3.Insert2new(AAA)batterieswithcorrect+/direction. 4.Closethebatterycover. Environment Protection Waste electrical products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local Authority or retailerforrecyclingadvice. INTRODUCTIONTOTHESYSTEM 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.TheBloodGlucoseMonitoringSystemisintendedtobeusedbyasinglepatientand shouldnotbeshared. TheBloodGlucoseMonitoringSystemisintendedforselftestingoutsidethebody(invitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetescontrol.TheBloodGlucoseMonitoringSystemisnottobeusedforthediagnosisof orscreeningofdiabetes,orforneonataluse. TheTestStripsareforusewiththeBloodGlucoseMetertoquantitativelymeasureglucose drawnfromthefingertips. Caution The system is intended for use outside the body (in vitro diagnostic use). It is for singlepatientuse.Itshouldbeusedonlyfortestingglucose(sugar)andonlywithfresh capillarywholebloodsamplestakenfromthefingerandthealternativesitesincluding thepalm,theforearm,theupperarm,thecalfandthethigh.Thesystemisintendedfor use at home. It should not be used for the diagnosis of diabetes or for the testing of newborns. TheSystemistobeusedbyasinglepersonandshouldnotbeshared. The System is intended for selftesting outside the body (in vitro diagnostic use) by 4/19 peoplewithdiabetesathomeasanaidtomonitortheeffectivenessofdiabetescontrol. Alternativesitetestingshouldbedoneonlyduringsteadystatetimes(whenglucoseis notchangingrapidly). The Bioland Test Strips are for use with the Blood Glucose Meter to quantitatively measureglucoseinfreshcapillarywholebloodsamplesdrawnfromthefingertips,palm, forearm,upperarm,calfandthigh. 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.Thesesolutionscontainaknownrangeofglucose,asindicatedonthestrips vialbottles. This device is not intended for use in healthcare or assisteduse settings such as hospitals, physicians offices, or longterm care facilities because it has not been determinedtobesafeandeffectiveforuseinthesesettings,includingforroutine assistedtestingoraspartofglycemiccontrolprocedures. Use of this device on multiple patients may lead to transmission of Human ImmunodeficiencyVirus(HIV),HepatitisCVirus(HCV),HepatitisBVirus (HBV), or otherbloodbornepathogens. ASTinthissystemcanbeusedonlyduringsteadystatebloodglucoseconditionsdescribedin thesectionofAboutAST. 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 dependsontheamountofglucoseinthebloodsample. ABOUT ALTERNATIVE SITE TESTING
(AST) Important.TherearelimitationsfordoingAST. PleaseconsultyourhealthcareprofessionalbeforeyoudoAST. WhatisAST?
Alternative site testing (AST) means that people use parts of the bodyotherthanthefingertipstochecktheirbloodglucoselevels. Thissystemallowsyoutotestonthepalm,theforearmtheupper arm,thecalforthethighwiththeequivalentresultstofingertips testing. Whatstheadvantage?
Fingertipsfeelpainmorereadilybecausetheyarefullofnerveendings(receptors).Atother bodysites,sincenerveendingsarenotsocondensed,youwillnotfeelasmuchpainasatthe fingertip. 5/19 WhentouseAST?
Food,medication,illness,stressandexercisecanaffectbloodglucoselevels.Capillaryblood atfingertipreflectsthesechangesfasterthancapillarybloodatothersites.Thereforewhen testingbloodglucoseduringorimmediatelyaftermeal,physicalexercise,oranyotherevent, takeabloodsamplefromyourfingeronly.YoudoASTonlyinthefollowinginstances:
Twohoursormoreaftertakinginsulin. Twohoursormoreafterexercising. NOTE:
Alternative site testing(AST) should not be used to calibrate continuous glucose Inapremealorfastingstate(morethan2hourssincethelastmeal). monitoringsystems(CGMs). Resultsfromalternativesitetestingshouldnotbeusedininsulindosescalculations. DoNOTuseASTif:
Youthinkyourbloodglucoseislow. Youareunawareofhypoglycemia. Youaretestingforhyperglycemia. YourASTresultsdonotmatchthewayyoufeel. Yourroutineglucoseresultsareoftenfluctuating. CONTENTSOFTHEKITS AMeter CarryCase OwnersManual TwoAAAAlkalineBatteries TestStrips(Optional) SterileLancet(Optional) ControlSolution(Optional) NOTE:
TheLancingDevicecanbeusedforseveraltimeshoweverthelancetshouldbechanged LancingDevice aftereachuse. Sterilelancetandcontrolsolutionarenotincludedinthestandardkit. Therearethreelevelsforthecontrolsolutions:low,normalandhighavailable,please contacttheplaceofpurchaseformoreinformation. Ifanyitemsaremissingfromyourkitoropenedpriortouse,pleasecontactlocalcustomer servicesorplaceofpurchaseforassistance. 6/19 Blood Glucose Meter 1. STRIPPORTWhereyouinserttheteststrip. Themeterwillturnonautomatically 2. DATAPORTLocatedatthesideisforcable connection 3.STRIP EJECTOR Slideforwardtoejectthe teststripaftertest 4.LCDDISPLAYItguidesyouthroughthetest usingsymbolsandsimplemessages 5."M"BUTTONItisusedtoturnonthemeter enterthememorymode 6. "S"BUTTONItisusedtosetupthemeter Meter Screen Display Message 1) BLOODDROPSYMBOL:Flasheswhenitisready toapplythebloodsample 2) TESTSTRIPSSYMBOL:Appearswhenthemeteris 3) turnedon LOWBATTERYSYMBOL:Appearswhenthe batterypowerislow 4) MEASUREMENTUNIT:Appearswiththetest resultinmg/Mlormmol/L 5) CTLSYMBOL:AppearswhendoingaControltest andindicatesThattheresultwon/tbeStoredin thememory 6) MEMORYSYMBOL:Appearswhenyoureview thememory 7) TESTRESULTAREA:Displaysglucoseresults 8) KETONEWARNING:Appearswhenyourresult13.3mmol/L(240mg/dl) 9) BLUETOOTHSYMBOL:Appearswhentransmitdata 10) DATE 11) DAYAVERAGE:Indicatethatthedisplayedtestresultisanaveragevalue 12) TIME Test Strip Each strip can be used only once. The test strip consists of the followingparts:
1Absorbenthole Applyadropofbloodhere.Thebloodwillbedrawninautomatically. 7/19 2Confirmationwindow This is whereyou confirmif enough bloodhas beendrawn intothe absorbent hole of the strip. 3Teststriphandle Holdthisparttoinserttheteststripintotheslot. 4Contactbars Insertthisendoftheteststripintothemeter.Pushitinfirmlyuntilitwillgonofurther. Attention!
Test results might be wrong if the contact Bar is not fully insertedintothetestslot. Thefrontsideoftheteststripshouldfaceupwheninserting theteststrip. SETTINGTHEMETERANDDELETINGTHEMEMORY 1.Settingthelanguageandvoicevolume 1.1Settingthelanguage PressandHoldSbuttonfor3seconds,untiltheENGor ESPisflashing.PressMbuttontoselectalanguageyou desire.PressS. 1.2SettingtheVolume WiththeVolumelevelnumberflashing,PressMbuttontoselectlevel between0~7(set0toturnedoffvoice).PressS. 2.Settingthedateandtime 2.1SettingtheYear PressandHoldSbutton for3seconds,untilthelasttwodigitsofthe yearwillflashonthescreen(forexample,14equals2014).PressM buttonuntilthecorrectyearappears.PressS. 2.2Settingthemonth Withthemonthflashing,pressMuntilthecorrectmonthappears. PressS. 8/19 2.3Settingtheday Withthedayflashing,PressMuntilthecorrectdayappears.PressS. 2.4SettingtheAM/PM WiththeAMorPMflashing,PressMuntilthecorrectoneappears. PressS. 2.5Settingthehour Withthehourflashing,PressMuntilthecorrecthourappears.PressS. 2.6Settingtheminute Withtheminuteflashing,PressMuntilthecorrectminuteappears. PressS. 3.DeletingtheMemory PressSthendELwilldisplaywithflashingM. PressMonce,toconfirmdelete,pressMbuttonagaintodeleteALL memory.ThemeterthendisplaysOK,whichmeans thatthememoryisdeleted.Ifyoudontwantto deletethememory,presstheSbuttontoskipthis step.ThemeterwillautomaticallyturnOFF,and thesetupwillbecompleted. NOTE:
Thedate,time,unitandmemorydeletioncanONLYbesetinthesettingmode. Whenthemeterisinsettingmode,ifnobuttonispressedwithin3minutes,themeter willturnoff. Nosetupnecessary,meterispreset.MeterispresetforEasternStandardTime.Please refertopage13ofthismanualforsetupinstruction. 4.SpeakingFunction CleverChoiceVoiceHDmeterspeakswithstepbystepinstructionstoguideyouthrough theprocessofsettingupyourmeterandbloodglucosetesting.Thefollowingtabletellsyou whenandwhatthemeterspeaks/
Whendoesthemeterspeak?
Whatdoesthemeterspeak?
Choosingthelanguage Settingmode,thankyouforusingthis Settingupthemeter 9/19 Settingthevoicevolume Settingtheyear Settingthemonth Settingthedate SettingtheAM/PM Settingthehour Settingtheminutes Deletingthememory Attheendofthemetersetting Usingthemeter Insertteststrip Whenthemeterisreadytotest. Aftersampleisappliedontotheteststrip Whenthetestiscompleted(resultappears ondisplay) Whenthetestresultis20mg/dL Whenthetestresultis 600mg/dL WhenselectedCTLforcontrolsolution testing Recallthestoredtestresult(pressMkeyto turnon) Recalltheaverageofbloodglucoseresults Ifnoresultsstoredinmemory Downloadingresultsfromyourmeteronto thecomputer WhendisplayEb product. Voicevolumeis(number) Theyearis(number) Themonthis(month) Thedateisthe(number) AM/PM Thehouris(number) Theminutesare(number) 1.Deleteallrecordmode.PressMkeyto deleteallrecords. 2.Areyousure?Yes,topressMkeyagain. 3.Allmemoryrecordhavebeendeleted. 1.Todaysdateis(month)(day),(year) 2.Thetimeis(hourminute)AM/PM 3.Thankyouforusingthisproduct 1.Teststripinserted 2.Todaysdateis(month)(day),(year) 3.Thetimeis(hourminute)AM/PM 4.Pleaseapplybloodontotheteststrip. Beep Yourbloodglucoseis(number)milligrams perdeciliter Yourbloodglucoseislessthan20milligrams perdeciliter Yourbloodglucoseisover600milligramsper deciliter Controlsolutionmode 1.Todaysdateis(month)(day),(year) 2.Thetimeis(hourminute)AM/PM 3.PressMkeyformemoryrecallmode 4.Memoryrecordfor(month)(day),(year)
(hourminute)AM/PM 5.Yourbloodglucosewas(number) milligramsperdeciliter The(number)daybloodglucoseaverageis
(number)milligramsperdeciliterfor
(number)records Nomemoryrecordavailable Connectingcomputer Thebatteryisdead,pleasereplace 10/19 Striphasbeenused Temperatureisoutofrange Wheninsertedanusedstrip Whenroomtemperatureisoutsideoperating range,whichis50~104(10~40) Whenerrormessageappear THETWOMEASURINGMODES Themeterprovidesyouwithtwomodesformeasuring,GeneralandCTL.TheCTLmode shouldbeusedwhenacontrolsolutionisbeingtested.Seethetablebelow. Usewhen Unabletomeasure Modes Generaltest(notdisplay) Anytimeofdaywithoutregardtotimesince lastmeal Testingwiththecontrolsolution CTL Youcanswitchbetweeneachmodeby:
1.Startwiththemeterturnedoff.Insertateststriptoturnonthemeter,the screenwilldisplayaflashingblooddrop. 2.PressMtoselectGeneralorCTLmode. TESTINGWITHBLOODSAMPLE CAUTION:
Toreducethechancesofinfection:
Chooseaclean,dryworksurface. Neversharealancingdeviceandlancetwithanotherperson. Alwaysuseanewandsterilelancet.Lancetsareforsingleuseonly. Alwaysuseanewteststrip.Teststripareforsingleuseonly. Avoidgettinglotion,oils,dirtordebrisinoronthelancetandlancingdevice. Note:Beforetesting,pleasereadthefollowingstepsthoroughlyandcarefully,pleaserelax anddotheteststepbystep.Simplifyingorchangingthetestproceduremayproduce inaccurateresults. 11/19 Overview of the Lancing Device A.DeviceCap B.Handle C.NeedleCap D.NeedleHolder E.DeviceBody F.ConnectingCollar G.Adjustabletip H.ReleaseButton I.EjectionButton J.Devicecontrolcap Onthelancetsandthelancingdevice. Ifyourlancingdevicediffersfromtheone shownhere,pleaserefertothemanufacturers manualtoensureproperusage. NOTE:
Toreducethechanceofinfection:
Neversharealancetorthelancingdevice. Alwaysuseanew,sterilelancet.Lancetsareforsingleuseonly. Avoidgenghandloon,oils,dirt,ordebriswhenhandlingthelancets. Setting Up the Lancing Device 1.Screwthelancingdevicecapoff.Insertaneedleintothelancet holderandpushdownfirmlyuntilitisfullyinplace. 2.Screwtheneedlecapandplaceitinappropriatelocationtouse againafterfinishbloodtaking. 3.Replacethelancingdevicecap.Turnthecapuntilitissnugbut nottootight.AndthenAdjusttheadjustabletiptoproperlevel. NOTE:Theadjustabletipoffers5levelsofskinpenetration.Twist theadjustabletiptotheproperlevel:
12levelforsoftorthinskin 3levelforaverageskin 45levelforthickorcallousedskin 12/19 4.Pullthedevicecontrolcapuntilitclicks.Ifnotclicks,checktheneedleisinstalled appropriately. 5.Aimingatthesterilizedpartforbloodtaking,pressthereleasekey tofinishbloodtaking. 6.Screwthedevicecap.Pushtheexposedneedleintotheneedlecap, andthenpushtheejectionbuttontodiscardtheusedneedlein appropriatecontainer.Coverthedevicecapatlast. Preparing the puncture site Stimulatingbloodperfusionbyrubbingthepuncturesitepriortobloodextractionhasa significantinfluenceontheglucosevalueobtained.Bloodfromasitethathasnotbeen rubbedexhibitsameasurablydifferentglucoseconcentrationthanbloodfromthefinger. Whenthepuncturesitewasrubbedpriortobloodextraction,thedifferencewassignificantly reduced. Pleasefollowthesuggestionsbelowbeforeobtainingadropofblood:
Rubthepuncturesiteforabout20secondsbeforepenetration. Selectthepuncturesiteeitheratthefingertipsoranotherbodypart (pleasesee sectionAlternativeSiteTesting(AST)onhowtoselecttheappropriatesites). Cleanthepuncturesiteusingcottonmoistenedwith70%alcoholandletitairdry. Fingertiptesting Holdthelancingdevicefirmlyagainstthesideofyourfinger.Press thereleasekey.Youwillhearaclick,indicatingthatthepunctureis complete. NOTE Chooseadifferentspoteachtimeyoutest.Repeatedpuncturesatthesamespotmay causesorenessandcalluses. PleaseconsultyourhealthcareprofessionalbeforeyoubeginAST. Itisrecommendedtodiscardthefirstdropofbloodasitmightcontaintissuefluid, whichmayaffectthetestresult. Performing a Blood Glucose Test Step1. Washhandswithsoapandwarmwater. 13/19 Step2. Removeateststripfromitsvial.Withclean,dryhands,youmaytouchtheteststrip anywhereonitssurface.Donotbend,cutormodifytheteststripsinanyway.Removethe teststripfromthevialanduseitinstantly. Step3. Inserttheteststripintothemeter'stestportandthemeteristurnedon.Thetimeanddate appearsonthescreen. NOTE:BesuretouseBiolandteststrips,otherteststripsmaynotproduceaccurateresults. Step4 Whentheblooddropsymbolflashesonthescreen,youmayselecttheappropriate measurementmode,forselectingthemeasurementmodeofControl(CTL)or General,pleaserefertotheTHETWOMEASURINGMODESsection. Step5 Applyyourbloodtotheabsorbentholeoftheteststrip. Step6 Assoonasenoughbloodhasfilledtheconfirmationwindowoftheteststrip,you willhearabeeplettingyouknowthetesthasbegun.Acountdownof5seconds starts. Note:makesuretheconfirmationwindowoftheTestStripiscompletelyfilledwithyour bloodsample. Step7 Yourbloodglucoselevel,alongdateandtimeappearsonthedisplay.Blood glucoseresultsareautomaticallystoredinthememory. When bluetooth connected, Bluetooth symbol flashing, and waiting for other device with Bluetooth to scan and connect, then upload the test results data. NOTE:
Theresultsobtainedfromthismeterareplasmacalibrated.Thishelpsyouandyourphysician orotherqualifiedhealthcareprovidertocompareyourmeterresultswithlaboratorytests. Referencetotheinstructionsgivenbyyourphysicianorotherqualifiedhealthcareprovider, donotdeviatefromtheseinstructionsonthebasisoftheresultwithoutfirstconsultingyour physician. 14/19 Step8 Ejecttheusedteststripandremovethelancet.Toejecttheteststrip, pointthestripatadisposalcontainerforsharpobjects.Themeterwill switchitselfoffautomaticallyaftertheteststripisejected. Pleasewashhandsthoroughlywithsoapandwaterafterhandlingthe meter,lancingdevice,orteststrips. Referencevalue:
Timeofday Beforebreakfast(fasting) Twohoursaftermeals Normalplasmaglucoserangforpeoplewithout
<100mg/dL
<140mg/dL Source:AmericanDiabetesAssociation.StandardsofMedicalCareinDiabetes2012.Diabetes Care2012,35Suppl.1)S11S63.Pleaseworkwithyourdoctortodetermineatargetrange thatworksbestforyou. Comparing Meter and Laboratory Results Themeterprovidesyouwithwholebloodequivalentresults.Theresultyouobtainfromyour metermaydiffersomewhatfromyourlaboratoryresultduetonormalvariation.Meter resultscanbeaffectedbyfactorsandconditionsthatdonotaffectlaboratoryresultsinthe sameway.Tomakeanaccuratecomparisonbetweenmeterandlaboratoryresults,followthe guidelinesbelow. Beforegoingtothelab:
Doacontrolsoluontesttomakesurethatthemeterisworkingproperly. Fastforatleasteighthoursandthendocomparisontests,ifpossible. Takeyourmeterwithyoutothelab. Whilestayingatthelab:
Makesurethatthesamplesforbothtestsaretakenandtestedwithin15minutesofeach other. Washyourhandsandthenobtainabloodsample Neveruseyourmeterwithbloodthathasbeencollectedinagraytoptesttube. Usefreshcapillarybloodonly. CONTROLSOLUTIONTEST Materialneeded:
GlucoseMeter Teststrips Controlsoluon Whentodoacontrolsolutiontest:
Whenyoususpectthatthemeterorteststripsarenotworkingproperly. 15/19 Ifyourbloodglucosetestresultsarenotconsistentwithhowyoufeel. Aftertheteststripsareexposedtoextremeconditions. Afterdroppingthemeter. Thecontrolsolutionistocheckthatthemeterandtheteststripscanworktogetherasa systemandworkcorrectly. Step1 Inserttheteststriptoturnonthemeter.Inserttheteststripintothemeter. Waitforthemetertodisplaythedropsymbol. Step2 YoumaypressMbuttontoselectCTLmode,forselectingtheCTLmode, pleaserefertotheTHETWOMEASURINGMODESsection. Step3 Applythecontrolsolution Shakethecontrolsolutionvialthoroughlybeforeuse. Squeezeoutadropandwipeitoff,thensqueezeanotherdropandplaceitonthetipofthe vialcap. Holdthemetertomovetheabsorbentholeofteststripsoittouchesthedrop.Oncethe confirmationwindowfillscompletely,themeterwillbegincountingdown. Toavoidcontaminatingthecontrolsolution,donotdirectlyapplycontrolsolutionontoa strip. Step4 Theresultofthecontrolsolutionstestappearsonthedisplay.Theresultwillnotbestored underCTLmode. Theresultofthecontrolsolutionstestshouldbewithintherangeprintedontheteststripvial label.Ifthetestresultsfallsoutsidethespecifiedrangeprintedonteststripviallabel,repeat thetest.Resultsfallingoutsidethespecifiedrangemaybecausedby:
Errorinperformingthetest ExpiredorcontaminatedControlSoluon ExpiredorcontaminatedTestStrip MalfunconofyourMeter Ifyoucontinuetogetcontrolsolutiontestresultsthatfalloutsideoftherangeprintedonthe vial,thesystemmaynotbeworkingproperly,Donotusethemeter.Pleasecontactyour customersupportimmediately NOTE:Donotusetheexpiredcontrolsolution. VIEWINGRESULTSONTHEMETER Yourmeterstoresthe500mostrecentbloodglucosetestresultswithdatesandtimes.Italso provides7,14,21,28,60and90dayaveragesofyourbloodglucosetestresults. Note:Thecontrolsolutionreadingsarenotincludedintheaverageofyourresults. RecallingtheStoredTestResults 16/19 symbolwillflashwiththetimeanddatedisplayedonthe 1.Startwiththemeteroff,presstheMbuttontoturnonthemeter. The screen. 2.PressMagain,themostrecenttestresultswithdateand timewilldisplay.PressMoncemoreandthenextmost recenttestresultswillappear.Eachtimeyoupressandrelease M,themeterwillrecalluptoyourlast500testresultsin order.PresstheStoturnoffthemeter.Whenthememoryis full,theoldestresultisdroppedandthenewestresultis added. ReadingtheAverageofBloodGlucoseResults Whenthemeterisoff,pressandholdtheMbuttonuntilthe DAYAVGflashing,releasebuttonthen7dayaverageresults appearwithn024(means24recordstobeaveraged)onthe screen.PresstheMbuttontoreviewthe14,21,28,60and 90daygeneralaverages.PresstheSbuttontoturnoffthe meter.Note:Thecontrolsolutionreadingsarenotincludedintheaverageofyourresults. CAREANDSTORAGEFORYOURSYSTEM Handlethemeterwithcare.Droppingorthrowingthemetermaycausedamagetothe device. Don'texposetheBloodGlucoseMonitoringSystem,Teststrip,andControlSolution,to extremeconditions,suchashighhumidity,heat,freezingcoldordust.Thestorage conditionsfortheteststripsare39~86,Humidity80%RH.Storageconditionsforthe meterare40~131,Humidity80%RH. Alwayswashyourhandswithsoapandwaterandrinseanddrycompletelybeforehandling theBloodGlucoseMonitoringsystemandTeststrip. UseCaviWipes(seebelow)tocleantheBloodGlucoseMonitoringSystem. Discardtheusedlancetintoacontainerforsharpobjects. Cleaning and Disinfection Thecleaninganddisinfectionisabsolutelynecessaryforthetestprocedure,becausecleaningcan insurethemeterworkswell(forexample,displaywillbecleartoseeaftercleaning);and disinfectioncanavoidtheinfectiontoyouortotheotherpeople,andthecrossinfection.We stronglywarnthatthedeviceshouldbecleanedanddisinfectedfollowinguseoneverypatient. Andwesuggestyouusethefollowingproduct:CaviWipes(EPAregistrationnumber467818. Youcanpurchasethisproductaccordingtothefollowinginformation:visitthewebsite:
www.metrex.comorcontactMetrexat8008411428forproductortechnicalinformation. CaviWipesarealsoavailableatwww.amazon.comorviaaGooglesearch. 17/19 Themeterforsinglepatientuseandthelancingdevicesmaybecleaned56timesperday(Test 56timeseveryday),sothemeterwillbecleanedanddisinfectabout11000cyclesthatinclude cleaningsplusdisinfections(1cycle=1cleaning+1disinfection)duringits5yearslifecycle. 1.Beforethetest,theusershouldcleanandwashhands.Ifyouareacaregiver,(notthepatient), pleaseusedisposablegloves. 2.Aftertest,takeonewipetocleanthemetershousing,buttons,lens,mark,usbcoverand supportblock,includingitsfrontandbackfor10secondsforcleaninguntilthereisnosoilon thesurface.Thendisinfectthemetershousing,buttons,lens,mark,usbcoverandsupport blockuseanotherwipefor2min,keepthesurfacewetfor2min. 3.Takeofftheglove;discardcarefullyaccordingtoyourhealthcareprovidersinstruction. Note:
1.Eachdisinfectionsteprequiresaprecleaningstep. 2.Ifthemeterisbeingoperatedbyasecondpersonwhoisprovidingtestingassistancetothe user,themeterandlancingdeviceshallbecleanedanddisinfectedfirst. 3.Theusersshouldwashhandsthoroughlywithsoapandwaterafterhandlingthemeter,lancing device,orteststrips. METERSPECIFICATION Model Machinesize Weight Measuringmethod Measuringrange BloodSource BloodVolume Memory Display Powersource BatteryLife Operatingconditions StorageCondition(system:meterandtest strips) StorageCondition(meter) G427B(withBiolandteststripandcontrol solution) 90mm(L)54mm(W)13mm(H) 50g(excludingbatteries) Amperometrictechnologyusingglucoseoxidase 20mg/dL~600mg/dL Freshcapillarywholeblood Around1.8uL 448bloodglucosetests LCDdisplaywithbacklight DC3V(AAA2alkalinebatteries) Approx.500normaltests 50~104,Humidity:25%~80%RH 39.2~104and below 85% relative humidity 40~131,Humidity80%RH, 700hPa~1060hPa Fiveyears Uselife Limitations of use:
ThebloodMonitoringSystemisnotintendedforuseonneonates. ThebloodMonitoringSystemisnotintendedforuseonarteryblood,neonatesserumand plasma. 18/19 TheBloodGlucoseMetershouldbeusedwithBiolandteststrip. Thesystemcanbeuseduptoanaltudeof10744feet. Thefollowingsubstancesatlevelsgreaterthannormalortherapeuclevelsmaycause significantinterference(affecttheresultbygreaterthan10%)resultinginaninaccurateresult:
ascorbicacid,uricacid,hemoglobinacetaminophen,Dopamine,Ldopa,Ldopaand Tolbutamideetc.Thesesubstancesdonotaffecttestresultsinnormalconcentrationbutmay affecttestresultsinhighconcentration.Donotusehaemolysissample,icterussampleorhigh lipemiasamples. Thefollowingcompounds,whendeterminedtoinexcessoftheirlimitation,mayproduce inaccurateresults:
Compound Ascorbicacid Uricacid Acetaminophen Bilirubin Dopamine Ldopa Methyldopa Tolbutamide Triglycerides Hemoglobin Limitation 2mg/dL 10mg/dL 5mg/dL 15mg/dL 0.03mg/dL 0.45mg/dL 0.75mg/dL 24mg/dL 2000mg/dL 250mg/dL Paentsundergoingoxygentherapymayyieldfalselylowerresults. Notforuseforpaentsinahyperglycemichyperosmolarstate,withorwithoutketosis. Notforuseoncriticallyillpatients. Nottobeusedforpaentswhoaredehydrated,hypertensive,hypotensiveorinshock. Verylow(lessthan20%)orveryhigh(morethan60%)redbloodcellcount(hematocrit)can leadtoincorrecttestresults.Ifyoudonotknowyourhemarocritlevel,pleaseconsultyour healthcareprovider. DISPLAYMESSAGE MESSAGE WHATITMEANS ACTION Bloodglucoselevelislower than20mg/dl(1.1mmol/L) Themessageindicatesverylowblood sugar.Youshouldconsultwithyour healthcareprofessional. Bloodglucoselevelishigher Thisindicatesseverhyperglycemia than600mg/dl(33.3mmol/L)
(highbloodglucose). Youshouldseekimmediatemedical assistance. 19/19 Meterisreadytotestcontrol Pleaseplaceadropofcontrolsolution solutionundertheCTLstate. ontothetestwellofteststrip. Batterypowerislow. Pleasechangethebattery. MESSAGE WHATITMEANS ACTION Useausedteststrip Pleaseuseanewstripandretest Problems Problems Display remains blank after the strip has test been inserted intotheMeter. Test results are incon sistent or Control Solution test results are notwithin the range. specified Errormassageindicatesthat youmayremovethestripafeter applyingbloodtotheabsorbent hole Problemwiththemeter Tryagainwithanewteststrip Retestwithanewteststrip.Ifthe problemisstillunsolved,pleasecallthe customercarelineforhelp. Environmentaltemperatureis lowerthan50~104 Pleasetestatanenvironmental temperaturewithin50~104 operationrange Causes Solutions installed 1. Battery may be improperly. 2. Battery power is too low for use. 3. Too much time has passed betweeninsertingtheTestStrip andperformingthetest. 44. Test Strip has not been fully insertedintotheMeter. 1.NotenoughsampleintheTest Strip. 2. Test Strip or Control Solution hasexpired. 3. Test Strip has been damaged duetoheatorhumiditysothat samplecannotbeappliedorthe speedofapplyingsampleistoo slow. 44.Systemisnotper formingdue 1.InstalltheBatterycorrectly. 2.ReplacewithnewBattery. 3.Reinsert the Test Strip into the 4. Reinsert the Test Strip into the Meter. Meter. 1. Redo test with new test strip and make sure that enough sample has beenadded. 2.Redotestwithnewteststrip. 3.PerformaControlSolutiontestusing anewTestStrip.Ifresultsarestillout ofrange,replacewithnewvialofTest Strips. 4. Bring System to a roomtemperature environmentand 20/19 totheenvironmentbeingabove orbelowroomtemperature. TestStriphasnotbeeninserted correctly. wait approximately 30 minutes before per forminganewtest. UseanewTestStripandredothetest. The Meter co untdown did not start. Bioland Technology LTD. No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong Road, Baolong Community Longgang District 518116, Shenzhen, Guangdong PEOPLES REPUBLIC OF CHINA Version: V1.0 @ 2016-01 by Bioland Technology LTD. 21/19
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2016-05-27 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2016-05-27
|
||||
1 | Applicant's complete, legal business name |
Bioland Technology Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0025357419
|
||||
1 | Physical Address |
A6b7 (Block G), Shangrong Ind. Zone
|
||||
1 |
Shenzhen guangdong, N/A 518116
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
h******@acbcert.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AHLE
|
||||
1 | Equipment Product Code |
BGMB001
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
Q**** L********
|
||||
1 | Telephone Number |
(86) ******** Extension:
|
||||
1 | Fax Number |
(86) ********
|
||||
1 |
r******@bioland.com.cn
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co., Ltd
|
||||
1 | Name |
K****** X********
|
||||
1 | Physical Address |
No.1 Workshop, M-10, Middle Section, Science
|
||||
1 |
Shenzhen, 518057
|
|||||
1 |
China
|
|||||
1 | Telephone Number |
86755********
|
||||
1 | Fax Number |
86755********
|
||||
1 |
k******@sgs.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Glucose Monitoring System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power Output listed is conducted. End-user and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
SGS-CSTC Standards Technical Services Co.,Ltd.
|
||||
1 | Name |
J******** Z****
|
||||
1 | Telephone Number |
86755******** Extension:
|
||||
1 | Fax Number |
86075********
|
||||
1 |
J******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0010000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC