Bluetooth4.0PulseOximeter ADF-B06

FCCStatement ThisdevicecomplieswithPart15oftheFCCRules.Operationissubjecttothefollowingtwoconditions:(1)thisdevicemaynotcauseharmfulinterference.(2)thisdevicemustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.NOTE:Thisequipmenthasbeentestedandfoundtocomplywiththelimits

foraClassBdigitaldevice,pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,uses andcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordance withtheinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theserisencouragedtotrytocorrecttheinterferencebyoneormoreofthefollowingmeasures:●Reorientorrelocatethereceivingantenna.●Increasetheseparationbetweentheequipmentandreceiver.●Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiverisconnected.●Consultthedealeroranexperiencedradio/TVtechnicianforhelp.

Warning:Changesormodificationstothisunitnotexpresslyapprovedby thepartyresponsibleforcompliancecouldvoidtheuser’sauthoritytooperatetheequipment. Precautions l DonotattempttomaintaintheOximeterunlessyouareprofessional

engineers.Onlyprofessionalswithmaintenancequalificationareallowedtoperforminteriormaintenanceasnecessary.

l PeriodicallychangethecontactpositionbetweentheOximeterprobeandthefingerforameasurementthatlastsalongtime.Adjustthepositionoftheprobebeforethemeasurementlaststwohours,andchecktheintegrityofskin,thebloodcirculationconditionofthefingeraswellasthepositionofthefinger.

l Thisproductisnotapplicabletotheexaminationofnewbornbabies.l Seekformedicalcareintimeifthemeasuredvaluegoesbeyondthe

normalrangewhileyouaresurethattheinstrumentdoesnotmalfunction.

l Donotdirectlyexposeyoureyestolight-emittingcomponentsoftheOximeter,asthatcouldcauseharmtoyoureyes.

l Fordetailsaboutclinicallimitationsandcontraindications,please

carefullyconsultrelevantmedicalliteratures.

The following factors may cause disturbance to or affect the accuracy of

examination:

◆ Thisproductisusedinanenvironmentinvolvinghigh-frequencydevices,

suchashigh-frequencyelectricknivesandCTapparatuses.◆ TheprobeoftheOximeterisplacedonthesamebodypartorlimbas

withbloodpressurecuffarterialductorintravenousinjection.

◆ Theusersuffersfromhypotension,severevascularatrophy,severe

anemia,orlowoxygen.

◆ Theuserisinsuddencardiacarrestorshockstate.

◆ Thefingerwithnailpolishorafakefingernailmaycausewrongreadings

ofpulseoxygensaturation.

Warnings

Warning:DonotusetheOximeterinanenvironmentwithanyinflammablegases,

inflammableanesthetic,orotherinflammablesubstances.

Warning:Donotattempttochargeanycommondrybattery,asthatcouldcause

leakage,firedisaster,orevenexplosion.Disposeofexhaustedbatteriesin

accordancewithenvironmentprotectionregulations.

Warning:DonotusetheOximeterinanMRIorCTenvironment.

Warning:DonotoperatetheOximeterwhenitisdampwithoverfloworwater

vaporcondensation.AvoidmovingtheOximeterfromanexcessively-cold

environmenttoahigh-temperaturemoistenvironment.SymbolConventions

Symbol Description BF-typeapplicationpart Caution:Pleaseseethismanual.

%SpO2 SymbolofoxygensaturationbpmPR Symbolofpulserate

Bluetoothsymbol

When end users abandon this product, theymust send the product to the collection placeforrecycling.

Overview

Oxygensaturationisthepercentageofoxyhemoglobin(HbO2)thatiscombined

withoxygenagainstallcombinablehemoglobin(Hb).Itisanimportant

physiologicalparameterinvolvedinrespirationandcirculation.Theoxygensaturationofarterialbloodinanormalhumanbodyis98%.Oxygensaturationisan

importantindicatoroftheoxygenconditioninthehumanbody.Ingeneral,the

normalvaluesofoxygensaturationshallnotbelowerthan94%.Ifthemeasured

valueofoxygensaturationislowerthan94%,aninsufficientsupplyofoxygenis

considered.Thepulserateisthenumberofpulsebeatsperminute.Normally,thepulserateis

consistentwiththeheartrate.Ingeneral,thepulserateofeverypeopleis60to90

beatsperminute. ThePerfusionIndex(PI)usuallyreflectsthelimbperfusionstatusofanexamined

patient,andshowsthedetectionprecisionoftheinstrumentaswell;thatis,

examinationcanstillbeperformedevenintheloworweakperfusioncondition.The

PIofanormalhumanbodyis3%orgreater.

WorkingPrinciples,ExpectedUsage,andApplicableScope Basedonfulldigitaltechnology,theFingerPulseOximeternon-invasivelymeasures

theactualcontent(oxygensaturation)ofoxyhemoglobin(HbO2)inarterialblood

usingtheopticaltransmittancemethod.

TheFingerPulseOximetermeasuresthebloodoxygensaturationandpulserateof

ahumanbodyviafingerartery.Itisapplicabletoawiderangeoffields,suchas

families,hospitals(includingoperationroomsofthedepartmentsofinternal

medicineandsurgery,thedepartmentofanesthesiology,thedepartmentof

paediatrics,andintensivecarerooms),oxygenbars,socialmedicalcareinstitutions,

andsports&health.Usethisinstrumentformeasurementbeforeoraftersports.

Youarenotadvisedtousethisinstrumentduringsportsactivities.Itisapplicableto

patients15to60yearsold.Donotuseitforcontinuouscareforpatients.

SchematicDiagramofDisplay The following figure shows the information display on the OLED screen of the

Oximeterinnormaldetectionstate:

Symbolofoxygen saturation

Measuredvalueofoxygensaturation

Bargraph Plethysmogram Measuredvalueof

Pulserate PI Symbolofpulserate Batterypowerindication/Bluetoothsymbol(alternatelydisplayed)

Power-OnKey/FunctionalKeyOperations AfterpoweringontheOximeter,holdthepower-onkey/functionalkeyforabout

onesecond.TheOximetershowsaparametersettinginterface.Pressorholdthe

power-on/functionalkeytoperformcorrespondingoperations.Holdittosetan

item,orpressittoswitchanoptionorswitchthedisplaymode.Pressmeansno

morethan0.5seconds,whileHoldmeansmorethan0.5seconds.

AlertSoundSetting Holdthepower-onkey/functionalkeywhiletheOximeterisinpowered-onstate.

Parametersettinginterface1isdisplayed,asshowninthefollowingfigure.Move

"*"tothecorrespondingoption,andholdthefunctionalkeytosetAlmtoonand

setBeeptooff.WhenAlmissettoonandthemeasuredvaluesoftheblood

oxygensaturationandpulserategobeyondtheupperlimitorlowerlimit,the

Oximetergivesoffanalertsound.WhenAlmissettooffandthemeasuredvalues

gobeyondthelimit,theOximeterwillnotgiveanyalertsound.WhenBeepissetto

on,atickwillbeheardalongwithpulsebeatsduringpulseratemeasurement.

WhenBeepissettooff,nosoundwillbeoutputalongwithpulsebeatsduring

pulseratemeasurement.Whilethe"*"symbolstaysontheRestoreoption,hold

thefunctionalkeytorestorefactorysettings.

BrightnessSetting Onparameterinterface1,pressthefunctionalkeytoselecttheBrightnessoption

andthenholdthefunctionalkeytosetthebrightnesstoavaluerangingfrom1to5.

Thegreaterthevalue,thegreaterthebrightnessofthescreen.

Powersavingfunction TheADF-B06hasapowersavingfeature.Itcansavepowerthroughreducing

screenbrightnessautomatically.Duringmeasurementthebrightnesswillreduceto

level1automaticallyafter150secondswithoutpressingthefunctionkey,tomake

itrecovertooriginalbrightnesspleasepressthefunctionkey.

AlertRangeSetting Onparameterinterface2,pressthefunctionalkeytoswitchbetweenoptions.On

thisinterface,youcansettheupperlimitandlowerlimitofSpO2AlmandPRAlm.

Whilethe"*"symbolstaysonthe+/-option,holdthefunctionalkeytosetthe

optionto+or-.In+mode,selectthecorrespondingoptionandholdthefunctional

keytoincrementtheupperorlowerlimit;in-mode,holdthefunctionalkeyto

decrementtheupperorlowerlimit.Move"*"totheExitoption,andholdthe

functionalkeytoreturntothemonitoringinterface.

OperationGuide

SwitchonthepowersupplyofthepulseOximeter

StickonefingercompletelyintotherubberpadcavityoftheOximeter,keepthe

fingernailsurfaceupward,andreleasetheclip.Thenpressthepowerkeytopower

ontheOximeter.

Ifyoudonotyetcompletelyinsert

yourfingerintothecavity,the

measurementresultmaybe

inaccurate.

Donotvibrateyourfingerduring

measurement.Preferably,ensure

thatyourbodydoesnotmove.After

thereadingsbecomestable,read

themeasuredvaluesof

oxygensaturationandthe

pulserateonthescreen.

TheOximeterwillautomaticallyshutdown10secondslaterafteryourfingerleaves

away.

ConnectdeviceviaBluetooth4.0

Priortofirstuse,downloadandinstall"Andesfit"applicationtoyourdevice.

(Bluetooth4.0capabilities)Fordetails,seequickstartguideforthephone/tablet.

AbouttheDisplay

Continuouslypressthefunctionalkeyinthemonitoringprocess.Themonitored

dataandthedisplaymodewillbecyclicallydisplayedontheOLEDscreenintwo

differentways(largefontsandplethysmogram)andfourdirections,asshownin

thefollowingfigure.

Replacethebatterieswhenthebatterycapacityisinsufficientandthesymbol

flickersonthescreen.

Cleaning Poweroff theinstrumentandremovethebatteriesbeforecleaning.Ensurethat

theappearanceoftheinstrumentisneat,dust-free,anddirt-free.Cleantheouter

surfaceoftheinstrument(includingtheOLEDscreen)using75%medicalalcohol

andapieceofdrysoftcloth.

Caution:Avoidliquidflowingintotheinstrumentduringcleaning.

Caution:Donotimmerseanypartoftheinstrumentintoanyliquid.

Disinfection Beforemeasurementwiththeinstrument,wipetherubberfingerpadusingapiece

ofdrysoftclothdippedwith75%medicalalcohol.Cleanthefingertobemeasured

usingthemedicalalcoholfordisinfectionpurposesbeforeandafteruse.

Maintenance l Removethebatteriesfromthebatteryslotandproperlystorethemifyoudo

notplantousetheOximeterforalongperiodoftime.

l StoretheOximeterbetween14and122°F(–10to+50°C)andathumiditylevelsnogreaterthan93%.

l PeriodicallychecktheOximeterfordamage.l AvoidusingtheOximeterinanenvironmentwithinflammablegasesorusingit

inanenvironmentwherethetemperatureorhumidityisexcessivelyhighor

low.

l Checktheaccuracyoftheoxygensaturationandpulseratereadingsbyusinganappropriatecalibrationapparatus.

TechnicalSpecifications 1. Dimensions:62.0mm(Width)×37.0mm(Depth)×32.0mm(Height)

Weight:42.5g(includingtheheightofthetwoAAAdrybatteries)

2. Peakwavelengthrangeofthelightemittedfromtheprobe:redlight660nm±

3;infraredlight905nm±5.

3. Maximumopticaloutputpoweroftheprobe:1.2mWforinfraredlight(905

nm).

4. Bluetoothmodule:4.0(single-mode)5. NormalworkingconditionWorkingTemperature 5°Cto40°C(41°Fto104°F)RelativeHumidity 15%to80%,non-condensing

AtmosphericPressure 70kPato106kPaRatedVoltage DC3.0V

6. DefaultvaluesandconditionsofalertParameter Value

Oxygensaturation Upperlimit:100Lowerlimit:94

Pulserate Upperlimit:130Lowerlimit:50

AlertconditionWhenthealertswitchisonandtheactualmeasuredvaluegoesbeyondthepresetalertparameterrange,theOximetergivesanalertsound.

7. TechnicalparametersParameter Value

DisplayrangeOxygen

saturation 35%to100%Pulserate 25bpmto250bpm

ResolutionOxygen

saturation 1%Pulserate 1bpm

Measurementprecision

Oxygensaturation

±2%(70%to100%)Norequirement(≤69%)

Pulserate ±2bpm

AlertrangeOxygen

saturationUpperlimit:50%to100%Lowerlimit:50%to100%

Pulserate Upperlimit:25bpmto250bpmLowerlimit:25bpmto250bpm

AlerterrorOxygen

saturation ±1%ofthepresetvalue

Pulserate Thegreaterof±10%ofthepresetvalueand±5bpm

PI WeakPI Min.0.2%SafetyType Anti-electric-shocktype:internalpowersupplydevice

Anti-electric-shockdegree:BF-typeapplicationpart

Waterproofgrade:IP22

StorageandTransportation Packagedproductsshouldbestoredinwell-ventilatedroomswithoutcorrosivegasandwithanambienttemperatureof–10to+50°C,arelativehumiditylowerthan93%(withoutcondensation),andanatmospheric

pressureof50–106kPa.

WellkangLtd

SuiteB,29HarleyStreet,LONDON,W1G9QR,U.K.