Bluetooth 4.0 Pulse Oximeter ADF-B06 · 2020. 1. 3. · Bluetooth 4.0 Pulse Oximeter ADF-B06 FCC...
Transcript of Bluetooth 4.0 Pulse Oximeter ADF-B06 · 2020. 1. 3. · Bluetooth 4.0 Pulse Oximeter ADF-B06 FCC...
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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.
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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
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pressureof50–106kPa.
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