Bioland Blood Glucose Monitor ModelG-427G 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 metermakingiteasierfortheusertomonitorblood glucose athome. IMPORTANT SAFETY INSTRUCTIONS The meter and lancing device are for single patient use. Do not share them with anyone 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. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End user must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be colocated or operating in conjunction withanyotherantennaortransmitter. The portable device is designed to meet the requirements for exposure to radio waves establishedbytheFederalCommunicationsCommission(USA).TheserequirementssetaSAR limitof1.6W/kgaveragedoveronegramoftissue.ThehighestSARvaluereportedunderthis standardduringproductcertificationforusewhenproperlywornonthebody Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcan bedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotrytocorrect theinterferencebyoneormoreofthefollowingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiver 1/19 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, 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 IndicationsforUse....................................................................................................................4 Caution......................................................................................................................................5 Testprinciple.............................................................................................................................5 ABOUTALTERNATIVESITETESTING(AST).........................................................................................5 CONTENTSOFTHEKITS.....................................................................................................................6 BloodGlucoseMeter.................................................................................................................7 MeterScreenDisplayMessage.................................................................................................7 TestStrip....................................................................................................................................8 SETTINGTHEMETERANDDELETINGTHEMEMORY........................................................................8 THETWOMEASURINGMODES.......................................................................................................10 TESTINGWITHBLOODSAMPLE......................................................................................................10 OverviewoftheLancingDevice..............................................................................................10 SettingUptheLancingDevice.................................................................................................11 Preparingthepuncturesite....................................................................................................12 PerformingaBloodGlucoseTest............................................................................................12 ComparingMeterandLaboratoryResults..............................................................................14 CONTROLSOLUTIONTEST...............................................................................................................14 VIEWINGRESULTSONTHEMETER.................................................................................................15 CAREANDSTORAGEFORYOURSYSTEM........................................................................................16 CleaningandDisinfection........................................................................................................16 METERSPECIFICATION....................................................................................................................17 Limitationsofuse:...................................................................................................................17 DISPLAYMESSAGE...........................................................................................................................18 Problems.................................................................................................................................19 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. 4/19 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 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. 5/19 WhatisAST?
Alternative site testing (AST) means that people use parts of the body other than the fingertipstochecktheirbloodglucoselevels.Thissystemallowsyoutotestonthepalm,the forearmtheupperarm,thecalforthethighwiththeequivalentresultstofingertipstesting. Whatstheadvantage?
Fingertipsfeelpainmorereadilybecausetheyarefullofnerveendings(receptors).Atother bodysites,sincenerveendingsarenotsocondensed,youwillnotfeelasmuchpainasatthe fingertip. 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 OwnersManual TestStrips(Optional) SterileLancet(Optional) ControlSolution(Optional) NOTE:
TheLancingDevicecanbeusedforseveraltimeshoweverthelancetshouldbechanged LancingDevice aftereachuse. Sterilelancetandcontrolsolutionarenotincludedinthestandardkit. 6/19 Therearethreelevelsforthecontrolsolutions:low,normalandhighavailable,please contacttheplaceofpurchaseformoreinformation. Ifanyitemsaremissingfromyourkitoropenedpriortouse,pleasecontactlocalcustomer servicesorplaceofpurchaseforassistance. Blood Glucose Meter 1. STRIPPORTWhereyouinserttheteststrip.Themeter willturnonautomatically 2. STRIP EJECTOR: Slide forward to eject the test strip aftertest 3. LCD DISPLAYIt guides you through the test using symbolsandsimplemessages 4."M"BUTTONItisusedtoturnonthemeterenterthe memorymode 5. "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) TRANSMISSIONSTATE:Appearswhenthedate transmitting,transmissionsuccessand transmissionfail 6) MEMORYSYMBOL:Appearswhenyoureview thememory 7) KETONEWARNING:Appearswhenyourresult 13.3mmol/L(240mg/dl) 8) TIME 9) DATE 10) TESTRESULTAREA:Displaysglucoseresults 11) GSMSignalStrength 7/19 Test Strip Eachstripcanbeusedonlyonce.Theteststripconsistsofthefollowingparts:
1Absorbenthole Applyadropofbloodhere.Thebloodwillbedrawninautomatically. 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.Settingthedateandtime 1.1SettingtheYear PressandHoldSbutton for3seconds,untilthelasttwodigitsofthe yearwillflashonthescreen(forexample,14equals2014).PressM buttonuntilthecorrectyearappears.PressS. 1.2Settingthemonth Withthemonthflashing,pressMuntilthecorrectmonthappears.Press S. 1.3Settingtheday Withthedayflashing,PressMuntilthecorrectdayappears.PressS. 1.4Settingthehour Withthehourflashing,PressMuntilthecorrecthourappears.PressS. 8/19 1.5Settingtheminute Withtheminuteflashing,PressMuntilthecorrectminuteappears.PressS. 2.DeletingtheMemory PressSthen anddELwilldisplaywithflashingnooryES. OR PressMuntilyESflashing,PresstheSbuttontodeleteallmemory.Themeterthen displaysOK,whichmeansthatthememoryis deleted.Ifyoudontwanttodeletethememory, whennoflashing,presstheSbuttontoskipthis step. 3.SettingtheAlarm Youmaysetupanyorallofthealarms(1~4).WhenthemeterisdisplayingOnorOFF, presstheMbuttontoturnonorturnoffthefirstalarm. PresstheSbuttontoselectOn,thentosetthehour.Whenthehourisflashing,pressthe Mbuttontoaddanhour.Whenthecorrecthourisset,presstheSbuttontoconfirmand gotosettheminutes.PresstheMbuttontoaddoneminute.Whenthecorrectminuteis set,presstheSbuttontoconfirmandgotothenextalarmsetting. Ifyouwanttoturnoffanalarm,presstheSbuttontofindtherightalarmnumberand presstheMbuttontochangefromOntoOFF. NOTE:
Thedate,time,unitandmemorydeletioncanONLYbesetinthesettingmode. Whenthemeterisinsettingmode,ifnobuttonispressedwithin3minutes,themeter willturnoff. 9/19 THETWOMEASURINGMODES Themeterprovidesyouwithtwomodesformeasuring,GeneralandCTL.TheCTLmode shouldbeusedwhenacontrolsolutionisbeingtested.Seethetablebelow. Usewhen Modes Generaltest(notdisplay) Anytimeofdaywithoutregardtotimesince lastmeal Testingwiththecontrolsolution CTL Youcanswitchbetweeneachmodeby:
1.Startwiththemeterturnedoff.Insertateststriptoturnonthemeter, thescreenwilldisplayaflashingblooddrop. 2.PressMtoselectGeneralorCTLmode. TESTINGWITHBLOODSAMPLE CAUTION:
Toreducethechancesofinfection:
Chooseaclean,dryworksurface. Neversharealancingdeviceandlancetwithanotherperson. Alwaysuseanewandsterilelancet.Lancetsareforsingleuseonly. Alwaysuseanewteststrip.Teststripareforsingleuseonly. Avoidgettinglotion,oils,dirtordebrisinoronthelancetandlancingdevice. Note:Beforetesting,pleasereadthefollowingstepsthoroughlyandcarefully,pleaserelax anddotheteststepbystep.Simplifyingorchangingthetestproceduremayproduce inaccurateresults. Overview of the Lancing Device A.DeviceCap B.Handle C.NeedleCap D.NeedleHolder E.DeviceBody F.ConnectingCollar G.Adjustabletip H.ReleaseButton 10/19 I.EjectionButton J.Devicecontrolcap Onthelancetsandthelancingdevice. Ifyourlancingdevicediffersfromtheoneshownhere,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 4.Pullthedevicecontrolcapuntilitclicks.Ifnotclicks,checkthe needleisinstalledappropriately. 5.Aimingatthesterilizedpartforbloodtaking,pressthereleasekey tofinishbloodtaking. 6.Screwthedevicecap.Pushtheexposedneedleintotheneedlecap, andthenpushtheejectionbuttontodiscardtheusedneedlein 11/19 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. Step2. Removeateststripfromitsvial.Withclean,dryhands,youmaytouchtheteststrip anywhereonitssurface.Donotbend,cutormodifytheteststripsinanyway.Removethe teststripfromthevialanduseitinstantly. Step3. Inserttheteststripintothemeter'stestportandthemeteristurnedon.Thetimeanddate appearsonthescreen. NOTE:BesuretouseBiolandteststrips,otherteststripsmaynotproduceaccurateresults. 12/19 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 GSM connected, GSM symbolflashing,andthetestresultsdatawilltransmissiontotheCloudsystem automatically. NOTE:
Theresultsobtainedfromthismeterareplasmacalibrated.Thishelpsyouandyourphysician orotherqualifiedhealthcareprovidertocompareyourmeterresultswithlaboratorytests. Referencetotheinstructionsgivenbyyourphysicianorotherqualifiedhealthcareprovider, donotdeviatefromtheseinstructionsonthebasisoftheresultwithoutfirstconsultingyour physician. Step8 Ejecttheusedteststripandremovethelancet.Toejecttheteststrip, pointthestripatadisposalcontainerforsharpobjects.Themeterwill switchitselfoffautomaticallyaftertheteststripisejected. Pleasewashhandsthoroughlywithsoapandwaterafterhandlingthe meter,lancingdevice,orteststrips. Referencevalue:
Timeofday Normalplasmaglucoserangforpeoplewithout 13/19 Beforebreakfast(fasting) Twohoursaftermeals
<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. Ifyourbloodglucosetestresultsarenotconsistentwithhowyoufeel. Aftertheteststripsareexposedtoextremeconditions. Afterdroppingthemeter. Thecontrolsolutionistocheckthatthemeterandtheteststripscanworktogetherasa systemandworkcorrectly. Step1 Inserttheteststriptoturnonthemeter.Inserttheteststripintothemeter. Waitforthemetertodisplaythedropsymbol. Step2 14/19 YoumaypressMbuttontoselectCTLmode,forselectingtheCTLmode,pleaserefertothe THETWOMEASURINGMODESsection. Step3 Applythecontrolsolution Shakethecontrolsolutionvialthoroughlybeforeuse. Squeezeoutadropandwipeitoff,thensqueezeanotherdropandplaceitonthetipofthe vialcap. Holdthemetertomovetheabsorbentholeofteststripsoittouchesthedrop.Oncethe confirmationwindowfillscompletely,themeterwillbegincountingdown. Toavoidcontaminatingthecontrolsolution,donotdirectlyapplycontrolsolutionontoa strip. Step4 Theresultofthecontrolsolutionstestappearsonthedisplay.Theresultwillnotbestored underCTLmode. Theresultofthecontrolsolutionstestshouldbewithintherangeprintedontheteststripvial label.Ifthetestresultsfallsoutsidethespecifiedrangeprintedonteststripviallabel,repeat thetest.Resultsfallingoutsidethespecifiedrangemaybecausedby:
Errorinperformingthetest ExpiredorcontaminatedControlSolution ExpiredorcontaminatedTestStrip MalfunconofyourMeter Ifyoucontinuetogetcontrolsolutiontestresultsthatfalloutsideoftherangeprintedonthe vial,thesystemmaynotbeworkingproperly,Donotusethemeter.Pleasecontactyour customersupportimmediately NOTE:Donotusetheexpiredcontrolsolution. VIEWINGRESULTSONTHEMETER Yourmeterstoresthe500mostrecentbloodglucosetestresultswithdatesandtimes.Italso provides7,14,21,28,60and90dayaveragesofyourbloodglucosetestresults. Note:Thecontrolsolutionreadingsarenotincludedintheaverageofyourresults. RecallingtheStoredTestResults 1.Startwiththemeteroff,presstheMbuttontoturnonthemeter. The screen. 2.PressMagain,themostrecenttestresultswithdateand timewilldisplay.PressMoncemoreandthenextmost recenttestresultswillappear.Eachtimeyoupressandrelease M,themeterwillrecalluptoyourlast500testresultsin order.PresstheStoturnoffthemeter.Whenthememoryis full,theoldestresultisdroppedandthenewestresultis symbolwillflashwiththetimeanddatedisplayedonthe 15/19 added. ReadingtheAverageofBloodGlucoseResults Whenthemeterisoff,pressandholdtheMbuttonuntilthe DAYAVGflashing,releasebuttonthen7dayaverageresults appearwithn024(means24recordstobeaveraged)onthe screen.PresstheMbuttontoreviewthe14,21,28,60and90daygeneralaverages.Press theSbuttontoturnoffthemeter.Note:Thecontrolsolutionreadingsarenotincludedinthe averageofyourresults. 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. 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. 16/19 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) G427G(withBiolandteststripandcontrol solution) 104mm(L)54mm(W)24mm(H) 64g(excludingbattery) Amperometrictechnologyusingglucoseoxidase 20mg/dL~600mg/dL Freshcapillarywholeblood Around0.7uL 500bloodglucosetests LCDdisplaywithbacklight DC3.7V(Litiumionbattery) Approx.400chargedischarecycles 50~104,Humidity:25%~80%RH 860hPa~1060hPa 39~104andbelow80%relativehumidity 700hPa~1060hPa 40~131,Humidity80%RH, 700hPa~1060hPa Fiveyears Uselife Limitations of use:
ThebloodMonitoringSystemisnotintendedforuseonneonates. ThebloodMonitoringSystemisnotintendedforuseonarteryblood,neonatesserumand plasma. TheBloodGlucoseMetershouldbeusedwithBiolandteststrip. Thesystemcanbeuseduptoanaltudeof10744feet. Thefollowingsubstancesatlevelsgreaterthannormalortherapeuclevelsmaycause significantinterference(affecttheresultbygreaterthan10%)resultinginaninaccurateresult:
ascorbicacid,uricacid,hemoglobinacetaminophen,Dopamine,Ldopa,Ldopaand Tolbutamideetc.Thesesubstancesdonotaffecttestresultsinnormalconcentrationbutmay affecttestresultsinhighconcentration.Donotusehaemolysissample,icterussampleorhigh lipemiasamples. 17/19 Thefollowingcompounds,whendeterminedtoinexcessoftheirlimitaon,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. Notforuseforpatientsinahyperglycemichyperosmolarstate,withorwithoutketosis. Notforuseoncricallyillpaents. 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. Meterisreadytotestcontrol Pleaseplaceadropofcontrolsolution solutionundertheCTLstate. ontothetestwellofteststrip. Batterypowerislow. Pleasechangethebattery. MESSAGE WHATITMEANS ACTION Useausedteststrip Pleaseuseanewstripandretest 18/19 Errormassageindicatesthat youmayremovethestripafeter applyingbloodtotheabsorbent hole Problemwiththemeter Tryagainwithanewteststrip Retestwithanewteststrip.Ifthe problemisstillunsolved,pleasecallthe customercarelineforhelp. Environmentaltemperatureis lowerthan50~104 Pleasetestatanenvironmental temperaturewithin50~104 operationrange Causes 1. Battery power is too low for use. 2. Too much time has passed betweeninsertingtheTestStrip andperformingthetest. 3. 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. 4.Systemisnotperformingdue totheenvironmentbeingabove orbelowroomtemperature. TestStriphasnotbeeninserted correctly. Solutions 1.Rechargethebatterybeforeuse. 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 wait approximately 30 minutes before per forminganewtest. UseanewTestStripandredothetest. 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 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 19/19 Version: V1.0 @ 2016-01 by Bioland Technology LTD. 20/19