Bioland Technology BGMG002 Blood Glucose Monitoring System User Manual G 427G x

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G-427G user manual

Bioland

Blood Glucose

Monitor

Model

：

G-427G

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.



syste



provides



Code



functio



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.



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co‐locatedoroperatinginconjunction

withanyotherantennaortransmitter.

Theportabledeviceisdesignedtomeettherequirementsforexposuretoradiowaves

establishedbytheFederalCommunicationsCommission(USA).TheserequirementssetaSAR

limitof1.6W/kgaveragedoveronegramoftissue.ThehighestSARvaluereportedunderthis

standardduringproductcertificationforusewhenproperlywornonthebody



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

2/19



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,

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

IndicationsforUse....................................................................................................................4

Caution......................................................................................................................................5

Testprinciple.............................................................................................................................5

ABOUTALTERNATIVESITETESTING(AST).........................................................................................5

CONTENTSOFTHEKITS.....................................................................................................................6

BloodGlucoseMeter.................................................................................................................7

MeterScreenDisplayMessage.................................................................................................7

TestStrip....................................................................................................................................8

SETTINGTHEMETERANDDELETINGTHEMEMORY........................................................................8

THETWOMEASURINGMODES.......................................................................................................10

TESTINGWITHBLOODSAMPLE......................................................................................................10

OverviewoftheLancingDevice..............................................................................................10

SettingUptheLancingDevice.................................................................................................11

Preparingthepuncturesite....................................................................................................12

PerformingaBloodGlucoseTest ............................................................................................12

ComparingMeterandLaboratoryResults..............................................................................14

CONTROLSOLUTIONTEST...............................................................................................................14

VIEWINGRESULTSONTHEMETER.................................................................................................15

CAREANDSTORAGEFORYOURSYSTEM........................................................................................16

CleaningandDisinfection........................................................................................................16

METERSPECIFICATION....................................................................................................................17

Limitationsofuse:...................................................................................................................17

DISPLAYMESSAGE...........................................................................................................................18

Problems.................................................................................................................................19



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.

5/19



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

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.

6/19



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.



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



Owner’sManual



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.

7/19





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.



BloodGlucoseMeter



1.STRIPPORT

：

Whereyouinserttheteststrip.Themeter

willturnonautomatically

2.STRIPEJECTOR:Slideforwardtoejecttheteststrip

aftertest

3.LCDDISPLAY

：

Itguidesyouthroughthetestusing

symbolsandsimplemessages

4."M"BUTTON

：

Itisusedtoturnonthemeterenterthe

memorymode

5."S"BUTTON

：

Itisusedtosetupthemeter

MeterScreenDisplayMessage

BLOODDROPSYMBOL:Flasheswhenitisready

toapplythebloodsample

2) TESTSTRIPSSYMBOL:Appearswhenthemeteris

turnedon

LOWBATTERYSYMBOL:Appearswhenthe

batterypowerislow

MEASUREMENTUNIT:Appearswiththetest

resultinmg/Mlormmol/L

TRANSMISSIONSTATE:Appearswhenthedate

transmitting,transmissionsuccessand

transmissionfail

MEMORYSYMBOL:Appearswhenyoureview

thememory

KETONEWARNING:Appearswhenyourresult

≧

13.3mmol/L(240mg/dl)

TIME

DATE

10)

TESTRESULTAREA:Displaysglucoseresults

11)

GSMSignalStrength



8/19



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.

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dateandtime

1.1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”.



1.2Settingthemonth

Withthemonthflashing,press“M”untilthecorrectmonthappears.Press

“S”.



1.3Settingtheday

Withthedayflashing,Press“M”untilthecorrectdayappears.Press“S”.



1.4Settingthehour

Withthehourflashing,Press“M”untilthecorrecthourappears.PressS“.

9/19



1.5Settingtheminute

Withtheminuteflashing,Press“M”untilthecorrectminuteappears.Press“S”.



2.DeletingtheMemory

Press“S”then” ”and“dEL”willdisplaywithflashing“no”or“yES”.



OR



Press“M”until“yES”flashing,Pressthe“S”button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,

when“no”flashing,pressthe“S”buttontoskipthis

step.



3.SettingtheAlarm

Youmaysetupanyorallofthealarms(1~4).Whenthemeterisdisplaying“On”or“OFF”,

pressthe“M”buttontoturnonorturnoffthefirstalarm.



Pressthe“S”buttontoselect“On”,thentosetthehour.Whenthehourisflashing,pressthe

“M”buttontoaddanhour.Whenthecorrecthourisset,pressthe“S”buttontoconfirmand

gotosettheminutes.Pressthe“M”buttontoaddoneminute.Whenthecorrectminuteis

set,pressthe“S”buttontoconfirmandgotothenextalarmsetting.



Ifyouwanttoturnoffanalarm,pressthe“S”buttontofindtherightalarmnumberand

pressthe“M”buttontochangefrom“On”to“OFF”.

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.



10/19



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.



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

11/19



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



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

12/19



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.



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.

13/19



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 GSM connected,

GSM

symbolflashing,andthetestresultsdatawilltransmissiontotheCloudsystem

automatically.



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.



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

14/19



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.

◆

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

15/19



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Solution

■

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

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

16/19



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.



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.

17/19



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‐427G(with“Bioland”teststripandcontrol

solution)

Machinesize104mm(L)×54mm(W)×24mm(H)

Weight64g(excludingbattery)

MeasuringmethodAmperometrictechnologyusingglucoseoxidase

Measuringrange20mg/dL~600mg/dL

BloodSourceFreshcapillarywholeblood

BloodVolumeAround0.7uL

Memory500bloodglucosetests

DisplayLCDdisplaywithbacklight

PowersourceDC3.7V(Litium‐ionbattery)

BatteryLifeApprox.400charge‐discharecycles

Operatingconditions50℉~104℉,Humidity:25%~80%RH

860hPa~1060hPa

StorageCondition(system:meterandtest

strips)

39℉~104℉andbelow80%relativehumidity

700hPa~1060hPa

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.

※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.



18/19



※Thefollowingcompounds,whendeterminedtoinexcessoftheirlimitaon,mayproduce

inaccurateresults:



Com

ound Limitation

Ascorbicacid ＞2mg/dL

Uricacid＞10mg/dL

Acetamino

hen ＞5mg/dL

Bilirubin＞15mg/dL

amine＞0.03mg/dL

L‐do

a＞0.45mg/dL

Meth

ldo

a＞0.75mg/dL

Tolbutamide ＞24mg/dL

Tri

cerides ＞2000mg/dL

Hemo

lobin ＞250mg/dL



※Paentsundergoingoxygentherapymayyieldfalselylowerresults.

※Notforuseforpatientsinahyperglycemic‐hyperosmolarstate,withorwithoutketosis.

※Notforuseoncricallyillpaents.

※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.



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

19/19



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poweristoolowfor

use.

2.Toomuchtimehaspassed

betweeninsertingtheTestStrip

andperfor‐mingthetest.

3.TestStriphasnotbeenfully

insertedintotheMete

1.Rechargethebatterybeforeuse.

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.

4.Systemisnotper‐formingdue

totheenvironmentbeingabove

orbelowroomtemperature.

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

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

20/19



Version: V1.0 @ 2016-01 by Bioland Technology LTD.



Bioland Technology BGMG002 Blood Glucose Monitoring System User Manual G 427G x

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

G-427G user manual

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