UT100 Handheld Pulse Oximeter Service Manual - … · UT100 Handheld Pulse Oximeter Service Manual...
Transcript of UT100 Handheld Pulse Oximeter Service Manual - … · UT100 Handheld Pulse Oximeter Service Manual...
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UT100HandheldPulseOximeter
ServiceManual
-EnglishVersion1.0,June2011
©2011UTECHCo.,Ltd.Allrightsreserved.
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TableofContents
HandheldPulseOximeterServiceManual I
TableofContentsChapter1:Introduction ..........................................................1-1
1.1AboutthisManual ................................................................ 1-11.2TechnicalDescription............................................................ 1-11.3ManufacturingQuality&Safety............................................ 1-11.4DeclarationofConformitywithEuropeanUnionDirective .... 1-11.5LimitedWarranty.................................................................. 1-2ServiceSupport .......................................................................... 1-2
Chapter2:GeneralDescription...............................................2-1
2.1IntendedUse ........................................................................ 2-12.2PatientSafety ....................................................................... 2-12.3WarningInformation ............................................................ 2-12.4DefinitionofSymbols............................................................ 2-32.5PreparationforUse............................................................... 2-4
2.5.1GettingAcquainted ...................................................................... 2-42.5.2PowerSupplyOptions .................................................................. 2-62.5.3PowerOn/Off ............................................................................... 2-72.5.4AutoPowerOff ............................................................................. 2-7
Chapter3:TheoryofOperation..............................................3-1
3.1TheoryofOperation ............................................................. 3-13.2CircuitStructureDiagram...................................................... 3-2
Chapter4:Tests .....................................................................4-1
4.1FunctionTests....................................................................... 4-14.1.1EquipmentRequired..................................................................... 4-14.1.2TestProcedure.............................................................................. 4-14.1.2CheckingDataOutput .................................................................. 4-2
4.2AccuracyTests ...................................................................... 4-24.2.1EquipmentRequired..................................................................... 4-34.2.2Procedure...................................................................................... 4-3
4.3ElectronicTests ..................................................................... 4-44.3.1EquipmentRequired..................................................................... 4-44.3.2Procedure...................................................................................... 4-4
Chapter5:Accessories............................................................5-1
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TableofContents
II HandheldPulseOximeterServiceManual
5.1StandardConfiguration .........................................................5-15.2OptionalAccessories .............................................................5-1
Chapter6:MaintenanceandTroubleshooting .......................6-1
6.1ScheduleofMaintenance ......................................................6-16.2CleaningandSterilization ......................................................6-1
6.2.1Pulseoximeter .............................................................................. 6-16.2.2SpO2FingerSensor ....................................................................... 6-1
6.3Storage..................................................................................6-26.4AssemblyExchanges..............................................................6-2
6.4.1InternalAssemblies ...................................................................... 6-26.4.2Reassemblingtheoximeter .......................................................... 6-3
6.3Troubleshooting ....................................................................6-3
Chapter7:Specification .........................................................7-1
7.1EquipmentClassification .......................................................7-17.2SpO2 ......................................................................................7-17.3PulseRate .............................................................................7-17.4DefaultSettingsofAlarmsLimits ...........................................7-17.5PowerRequirements .............................................................7-17.6BatteryLife............................................................................7-27.7Dimensions............................................................................7-27.8EnvironmentalSpecification ..................................................7-2
Chapter8:Drawings ..............................................................8-1
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Chapter1:Introduction
HandheldPulseOximeterServiceManual 1-1
Chapter1:Introduction1.1AboutthisManualThismanual iswritten for technicalpersonnel servicing theUT100HandheldPulseOximeter.This document contains information which is proprietary and property ofUTECH CO., LTD. Andmay not be reproduced, stored in a retrieval system,translated,transcribed,ortransmitted,inanyform,orbyanymeans,withoutthepriorexplicitwrittenpermissionofUTECHCO.,LTD.UTECHreservestherighttochangespecificationwithoutnotice. 1.2TechnicalDescriptionPerrequirementofIEC601-1,themodelUT100isclassifiedasclassIIequipment,internallypowered,withtypeBFappliedpart,andanenclosureprotectionratingofIPX1. Transport/Storage:-10to+55℃ (14-131F),10-95%R.H.non-condensingOperatingConditions:10to+40℃ (50-104F),10-90%R.H.non-condensing1.3ManufacturingQuality&SafetyTheUTECHmanufacturingfacilityiscertifiedtobothISO13485andEC46002(MDD93/42/EECAnnexII).UTECHproductsbarethe“CE0482”mark;andtestedbyTUVRheinlandtoIEC601-1/EN60601-1.1.4DeclarationofConformitywithEuropeanUnionDirectiveTheAuthorizedRepresentativeforUTECHequipmentis:WellkangLtdt/aWellkangTechConsultingSuiteB,29HarleyStreet,LONDONW1G9QR,England,UnitedKingdomPhone:+44(20)30869438 Fax:+44(20)76811874
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Chapter1:Introduction
1-2 HandheldPulseOximeterServiceManual
1.5LimitedWarrantyUTECHCO.,LTD.(“Seller”)warrants eachnewdevicetobefreefromdefectsinworkmanshipandmaterialsundernormaluseandserviceforaperiodofone(1)yearsfromthedateofshipment.ThesoleobligationofUTECHcompanyunderthiswarrantywillberepairorreplace,atitsoption,productsthatprovetobedefectiveduringthewarrantyperiod.Theforegoingshallbethesolewarrantyremedy. Except as set forth herein, seller makes no warranties, eitherexpressedor implied, includingthe impliedwarrantiesofmerchantabilityandfitness for a particular purpose. No warranty is provide if the products aremodified without the express written consent of UTECH company and sellershall not be liable in any event for incidental or consequential damage. Thiswarrantyisnotassignable.Warrantiesaresubject tochange.PleasecontactUTECHcompanyforcurrentwarrantyinformation.1.6ServiceSupportRepairsfordevicesmanufacturedbyUTECHcompanyunderwarrantymustbemade at authorized repair centers. If the device needs repair, contact yourlocal distributor or the UTECH company after-service department. Whencalling,havethedevice’smodelandserialnumberready.Ifyouneedtoshipthedevice,packthedeviceandaccessoriescarefullytopreventshippingdamage.Allaccessoriesshouldaccompanythedevice.
UTECHCO.,LTD.Add: 3rdfloor,NO.39,JinqiaoRoad,
Zhangjiawan,ShapingbaDistrict, Chongqing,China
Phone: (+86)23-6172-8390Fax: (+86)23-6172-8391E-mail: [email protected]:http://www.chinautech.com
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Chapter2:GeneralDescription
HandheldPulseOximeterServiceManual 2-1
Chapter2:GeneralDescription2.1IntendedUse TheUT100HandheldPulseOximeter isa lowcostmonitorforspotchecking,continuous, noninvasive monitoring or recording of functional oxygensaturation of arterial hemoglobin (SpO2), pulse rate and pulse strength. Themonitor isabatterypoweredpulseoximeter. Itmaybeused inthehospital,clinical environment, homecare, and during emergency land transportation.Theoximeterworkswith given sensors providing SpO2 andpulse rate on allpatientsfromneonataltoadult.Thisdevice isintendedforcontinuouspatient monitoring withadjustablealarmlimitsaswellasvisibleandaudible alarmsignals.NOTE! Themonitorwasnotdesignedortestedtobeanapneamonitor.2.2PatientSafety
Formaximumpatientandoperatorsafety,thefollowingarerecommended:! Careshouldbeexercisedtoassurecontinuedperipheralperfusiondistal
totheSpO2sensorsiteafterapplication.! DoNOTattachanSpO2sensordistaltoabloodpressurecuff.Validdata
CANNNOTbeprocessedwhenthecuffisinflated.Attachthesensortothelimboppositetothesiteusedforthebloodpressurecuff.
! Keepthedeviceanditsaccessoriesclean.Donotoperatethedevice
whenitiswetduetospillsorcondensation. ! Whereelectromagneticdevices(i.e.,electrocautery)areused,patient
monitoringmaybeinterruptedduetoelectromagneticinterference.Electromagneticfieldsupto3V/mwillnotadverselyaffectsystemperformance.
! Thedevicecontainsnouserserviceableparts.Referservicingtoqualified
servicepersonnel.2.3WarningInformation
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Chapter2:GeneralDescription
2-2 HandheldPulseOximeterServiceManual
KEYWORD DEFINITION
WARNING Tellsyousomethingthatcouldhurtthepatientorhurttheoperator.
CAUTION Tellsyousomethingthatcoulddamagethedevice.NOTE Tellsyouotherimportantinformation.
WarningsWARNING! ELECTRICALSHOCKHAZARDwhencoverisremoved.Donot
removecovers.Referservicingtoqualifiedpersonnel.WARNING! EXPLOSIONHAZARD:DoNOTusethedeviceinthepresenceof
flammableanesthetics.Useofthisinstrumentinsuchanenvironmentmaypresentanexplosionhazard.
WARNING! FailureofOperation:Ifthemonitorfailstorespondas
described,donotuseituntilthesituationhasbeencorrectedbyqualifiedpersonnel.
WARNING! PatientSafety:Careshouldbeexercisedtoassurecontinued
peripheralperfusiondistaltotheSpO2sensorsiteaftertheapplication.
WARNING! Donotpositionthesensorcableinanymannerthatmaycause
entanglementorstrangulation. CautionsCAUTION! Donotoperatethedevicewhenitiswetduetospillsor
condensation.CAUTION! Donotoperatetheproductifitappearstohavebendroppedor
damaged.CAUTION! Neversterilizeorimmersethemonitorandsensorsinliquids.CAUTION! Notensionshouldbeappliedtoanysensorcable.CAUTION! Operateattemperaturesbetween10to+40℃ .(50to104F),
10-95%R.H.non-condensing.
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Chapter2:GeneralDescription
HandheldPulseOximeterServiceManual 2-3
CAUTION! Avoidstoringthemonitorattemperatureslessthan-10Corgreaterthan+55C(<14For>131F0)10-95%R.H.non-condensing.
NotesNOTE! Useonlythemanufacturerapprovedsensorsandaccessorieswith
thedevice.
NOTE! Theproductanditsaccessorieswithhavepatientcontactarefreeoflatex.
NOTE! DataValidity:Aswithallpulseoximeters,inaccurateSpO2and
PulseRatevaluesmaybecausedby:
! Incorrectapplicationoruseofasensor! Significantlevelsofdysfunctionalhemoglobin;
carboxyhemoglobinormethemoglobin! Significantlevelsofindocyaninegreen,methyleneblue,or
otherintravasculardyes! Exposuretoexcessiveilluminationsuchassurgical
lamps-especiallyoneswithaxenonlightsource,ordirectsunlight
! Excessivepatientmovement! Venouspulsations! Electrosurgicalinterference
2.4DefinitionofSymbolsSYMBOLS DEFINITION
Attention,seeininstructionsforuse
TypeBFDefibrillation
Poweron/off
Alarmsilence
/ UpandDownArrows
ModeChangeKey
MenuKey
DateofManufacturingIPX1 DripProof(monitoronly)
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Chapter2:GeneralDescription
2-4 HandheldPulseOximeterServiceManual
CEMark
Indicatesseparatecollectionforelectricalandelectronicequipment.
2.5PreparationforUse2.5.1GettingAcquainted
Figure2.1:MonitorControls,andFeatures
1.SensorConnectorThesensorconnects here,oranoximetryextension cablecanbeconnectedbetweenthemonitor and the sensor.2.SpO2NumericDisplayAnumbershowsthepatient’sSpO2valueinpercent.Dashes(---)meanthemonitorisnotabletocalculatetheSpO2value.3.MuteiconThemuteiconisdisplayedatthestatusbarandithasthreestatuses:
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Chapter2:GeneralDescription
HandheldPulseOximeterServiceManual 2-5
“ ”thisiconmeansthenormalstatusofalarmsound. “ ”thisiconisdisplayedduringtemporary30sec,60sec,90sec,120secalarmsilence.“ ”thisiconisdisplayedsteadilyduringpermanentalarmsilence.4.PowerIndicatorThisindicatorlightssteadilytoinformtheworkingstatusofthemonitor.Greenmeansthemonitorworkingnormallyandredmeansalarmoccurred.5.PulseStrengthBarGraphThepulsestrengthbargraph“sweeps”withthepatient’spulsebeat.Theheight ofthebargraph showsthepatient’spulsestrength.6.SpeakerItprovidesaudibleindicationofalarmconditions,pulsetoneandfeedbackforkey-presses.Ensurethespeakerisnotcovered.7.PulseRateNumericDisplayAnumber showsthepatient’spulseratevalueinbeats perminute.Dashes(---)mean themonitor isnot abletocalculate thepulseratevalue8.InformationBarTheinformationbardisplayspatient’sID/type,batterylevelicon,date/time.9.BatterylevelIcon Thisiconisdisplayedattheinformationbarandhasfourlevels.Itflasheswhenthereisonly15minutesleftforthemonitorshutdownitself.10.StatusBarThestatusbardisplaysthetheremeasuringmodes,sensornoconnect/sensoroffline/pulsesearch/lowperfusioniconandvolumeicon.
11.CurrentAlarmLimitsofSpO2
Ifthehigh/lowalarmlimithasbeenchangedfromthedefaultsettings,therewillbeadecimalpointdisplayedafterit.12.AlarmbarThealarmbardisplayshighandmediumalarmeventstoalertusers.13.CurrentAlarmLimitsofPulseRateIfthehigh/lowalarmlimithasbeenchangedfromthedefaultsettings,therewillbeadecimalpointdisplayedafterit.
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Chapter2:GeneralDescription
2-6 HandheldPulseOximeterServiceManual
14.SilenceIndicatorThisindicator flashesduring temporary two-minutealarmsilence.Theindictorlightssteadilyduring permanent/indefinitealarmsilence.15.Slotforhangingstrap2.5.2PowerSupplyOptions Batteries.Freshdisposable“AA”alkalinebatteriesprovidedapproximately10hoursofoperation.Batterycapacitymaybereducedincoldertemperaturesorwithexcessivepowercycling.
Figure2.2:InstallingtheBatteries
Toinstall/replace thebatteries:1.Depressthebatterydoorandremoveitdownward.2.Installthenegativeendofeachbatteryfirst,compressingthebattery
terminalspringuntilthepositiveterminalclearsthepositivetab.Pressthebatterydownintoplace.
3.Placebatterydoorintotheslotsofthemonitorbackpanel,depressthe
doortab,andpressthedoorintoplace.
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Chapter2:GeneralDescription
HandheldPulseOximeterServiceManual 2-7
NOTE! Ifyouinstalldisposablebatteries,besuretodisposeofthemin
compliancewithyourinstitution’sguidelinesandlocalordinances.
NOTE! Theunitwillholddataforaboutoneandahalfminuteswith
nobatterypower.Thiswillinsurethesafetyoftrenddataduringbatteryreplacement.
ACCharger.TheACadaptercanbeusedtochargerechargeablebatteriesandusedasapowersupplywithoutanybattery.
Figure2.2:ConnectingACCharger
2.5.3PowerOn/OffToturnthepulseoximeteron,pressthepowerkey.
! “Checkok”andsoftwareversionwillbedisplayed. ! Anaudibletonesounds. ! Thepowerindicatorisbrieflyilluminated.
Toturnthepulseoximeteroff,pressthepowerkey.2.5.4AutoPowerOffAbatterypowersavingfeatureallowsthepulseoximetertoshutitselfoffafterwaiting5minuteswithoutdetectinganypulsatileactivity.
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Chapter2:GeneralDescription
2-8 HandheldPulseOximeterServiceManual
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Chapter3:TheoryofOperation
HandheldPulseOximeterServiceManual 3-1
Chapter3:TheoryofOperation
3.1TheoryofOperationThepulseoximeterdetermines%SpO2andpulseratebypassing twowavelengthsoflowintensity light,one redandone infrared,throughbodytissuetoaphotodetector.Informationabout wavelengthrange canbeespeciallyusefultoclinicians.Wavelength information forthisdevicecanbefound intheSpO2Specificationssection ofthismanual.Pulseidentificationisaccomplishedbyusingplethysmographictechniques,andoxygensaturationmeasurementsaredeterminedusingspectrophotometricoximetryprinciples.Duringmeasurement,thesignalstrengthresultingfromeachlightsourcedependsonthecolorandthicknessofthebodytissue,thesensorplacement,theintensityofthelightsources,andtheabsorptionofthearterialandvenousblood(includingthetimevaryingeffectsofthepulse)inthebodytissues.
1 2Figure3.1:TheoryofOperation
1.LowintensityRedandInfraredLEDlightsources2.DetectorOximetryprocesses these signals,separatingthe timeinvariantparameters(tissuethickness,skincolor,lightintensity,andvenous blood) fromthe timevariantparameters(arterialvolume andSpO2)toidentifythepulsesandcalculate functionaloxygensaturation. Oxygensaturationcalculations canbeperformed because blood saturatedwithoxygenpredictably absorbslessredlightthan oxygen-depletedblood.WARNING! SincemeasurementofSpO2dependsonapulsatingvascular
bed,anyconditionthatrestrictsbloodflow,suchastheuseofabloodpressurecufforextremesinsystemicvascularresistance,maycauseaninabilitytodetermineaccurateSpO2andpulseratereadings.
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Chapter3:ControlsandFeatures
3-2 HandheldPulseOximeterServiceManual
WARNING! Undercertainclinicalconditions,pulseoximetersmaydisplaydashesifunabletodisplaySpO2and/orpulseratevalues.Undertheseconditions,pulseoximetersmayalsodisplayerroneousvalues.Theseconditionsinclude,butarenotlimitedto:patientmotion,lowperfusion,cardiacarrhythmias,highorlowpulseratesoracombinationoftheaboveconditions.Failureofthecliniciantorecognizetheeffectsoftheseconditionsonpulseoximeterreadingsmayresultinpatientinjury.
3.2CircuitStructureDiagram
Figure3.2:CircuitStructureDiagram
3.2.1ON/OFFSwitchWhenthemonitoristurnedON(pressingthePOWERkeyfor3seconds)apositivepulsewillmakethesignalofKEY_POWREtoalowlevelandtheoutputsignalPWR_STBofU4toahighlevel.Thenthemonitorisstartingtowork.PressthePOWERkeyfor3secondsagainwhichmakestheoutputsignalPWR_STBofU4toalowlevel.Thenturnthemonitoroff.3.2.23.3VDigitalSupplyAswitch-modeboostregulatorU10isusedtogeneratethe3.3voltdigitalsupply(VCC_MCU)fromthebatteryvoltage.Itisdesignedtooperateoveraninputvoltagerangeof2.8V~16.0V.Theswitch-modecontrollerU10includesanOutputVoltageSense,andusetheresistorR25,R26toadjusttheoutputvoltage.TheoutputvoltagecanbecalculatedlikethisVout=Vth(R25/R26+1).
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Chapter3:TheoryofOperation
HandheldPulseOximeterServiceManual 3-3
3.2.35VSPO2PowerSupply APWMControlledStep-UpDC/DCConvertersU1transfersthechargingvoltageto+5.5V.Output+5VtosupplypowertotheSpO2boardbyahighlyprecise,lownoise,positivevoltageLDOregulatorsU9. 3.2.4BatteryChargingCircuitTheNi-MHbatterycontrollerICU12isusedtochargefullAANi-MHbatteries.ThehighlyprecisionADCcanjudgethechargingstatusprecisely.3.2.5MicrocontrollerThemicrocontrollerchosenforthepulseoximeteristheSTMicroelectronicsgroupofcompaniesSTM32F103VCT6.ThecoreisanARM32-bitCortex™-M3CPU,capableofrunningoffa3.3Vsupply,atupto72Mhz.Combinedwithitisampleinternalprogrammemory(512KbytesofFlashmemory)and64KbytesofSRAM.Thisdevicealsoincludesanumberofintegratedperipherals,whichmakeitidealforthisapplication.Thereareseveraltimers,andatimingpatterngenerator,whichwillbeusedtogeneratethefrontendtimingsignals;an8bitA/Dconverter,whichwillbeusedtomonitorthebatterystatus;TwoUARTserialports:oneisusedtocommunicatewithSpO2board,theotherisusedtocommunicatewithPC.TwoSPIinterfaces:oneconnectstheSPISerialFlash,theotherconnectstheAcceleration.Theflexiblestaticmemorycontroller(FSMC)canbeconfiguredtointerfaceseamlesslywithmostgraphicLCDcontrollers.ItsupportstheIntel8080andMotorola6800modes,andisflexibleenoughtoadapttospecificLCDinterfaces.ThisLCDparallelinterfacecapabilitymakesiteasytobuildcost-effectivegraphicapplicationsusingLCDmoduleswithembeddedcontrollersorhigh-performancesolutionsusingexternalcontrollerswithdedicatedacceleration.3.2.6Real-timeClockThemicrocontrollerintegratesRTCfunction.Thereal-timeclockprovidesasetofcontinuouslyrunningcounterswhichcanbeusedwithsuitablesoftwaretoprovideaclockcalendarfunction,andprovidesanalarminterruptandaperiodicinterrupt.Itisclockedbya32.768kHzexternalcrystal,resonatororoscillator,theinternallowpowerRCoscillatororthehigh-speedexternalclockdividedby128.Theinternallow-speedRChasatypicalfrequencyof40kHz.
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Chapter3:ControlsandFeatures
3-4 HandheldPulseOximeterServiceManual
TheRTCcanbecalibratedusinganexternal512Hzoutputtocompensateforanynaturalquartzdeviation.TheRTCfeaturesa32-bitprogrammablecounterforlongtermmeasurementusingtheCompareregistertogenerateanalarm.A20-bitprescalerisusedforthetimebaseclockandisbydefaultconfiguredtogenerateatimebaseof1secondfromaclockat32.768kHz.3.2.7SerialwireJTAGdebugport(SWJ-DP)TheARMSWJ-DPInterfaceisembedded,andisacombinedJTAGandserialwiredebugportthatenableseitheraserialwiredebugoraJTAGprobetobeconnectedtothetarget.TheJTAGTMSandTCKpinsaresharedrespectivelywithSWDIOandSWCLKandaspecificsequenceontheTMSpinisusedtoswitchbetweenJTAG-DPandSW-DP.3.2.8AudioThemicrocontroller’sgeneral-purposetimersusedtogenerateaPWMsignal.Use1.1WattAudioPowerAmplifierU7todrivethespeaker. 3.2.9ControlKeysSixuseroperated,controlkeysareprovided(Power,Up,Down,Mode,Silence,Menu).ThestateofthesekeyscanbereadbythesoftwareGPIO,whichareconfiguredasinputs.Theswitchlinesarenormallypulledhigh,untilakeyispressed.
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Chapter4:Tests
HandheldPulseOximeterServiceManual 4-1
Chapter4:Tests 4.1FunctionTestsThefunctionaltestingverifiesoverallfunctionalintegrityofthemonitorandsensor.Iftheoximeterdoesnotpassthesetests,removefromuseandcontactthemanufacturerservicedepartmentforrepair/replacementassistance. Thisprocedureassumesthetechnicianperformseachasindicated-leavingthemonitorinaknowstatepriortoperformingthenextstep.Ifthestepsareomittedorperformedoutoforder,besurethatthemonitorissettothecorrectstatebeforecontinuing. 4.1.1EquipmentRequired
1.SpO2FingerSensor,Adult.2.(4)“AA”rechargeablebatteries(Halfcharged)3.ACCharger. 4.PC.5.DateanalysissoftwareCD.6.USBCable.
4.1.2TestProcedure1.Visuallyinspectthemonitorandverifythattherearenocosmeticdefects.2.Verifyalllabelsareproperlyplaced.3.InstallfourAAbatteriesintothebatterycompartment.Becarefultofollow
polaritymarkings.Closebatterydoor.4.Turnontheunitbypressingthepowerbutton.Verifythefollowingpower
upsequenceoccurs:monitorwillbeeponpoweron,powerindicatorwillbelit,andthecurrentsoftwarerevisionwillbedisplayed.
5.Adjustthemeasuremodefromthedefaulted“Spot-check”tothe
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Chapter4:Tests
4-2 HandheldPulseOximeterServiceManual
“Monitoring”mode.Verifythatallthekeysareusable. 6.ConnecttheSpO2fingersensortotheunitandplacethesensoroveryour
finger.7.Verifysaturationandpulseratevaluesaredisplayedwithnoerror
messagesdisplayed.
8.VerifytheBatterylevelIconismovingwhenconnecttheACchargertothedevice.
9.TakeofftheACchargerandremoveyourfingerfromthesensor.Verifya“SensorOffline”messageisdisplayed.
10.Leavetheunitrunninginthisstateforapproximately5minutes.Verifyafter5minutesthattheunitshutsoffautomatically.
11.Theprocedureiscompleteremovethebatteriesanddisconnectthefingersensorfromtheunit.
4.1.2CheckingDataOutputWhenyouconducttheabovefifthstep,themeasuringdatahavebeenstoretothedevice. 1.Installthesoftware.2.ConnectUSBcable. 3.Downloadallthestoreddata. 4.2AccuracyTestsTheAccuracyTestsverifiedtheperformanceaccuracyofthedevice.Thistestistypicallyperformedinconjunctionwith(after)theFunctionalTests.IfthemonitordoesnotpasstheAccuracyTests,removefromuseandcontactthemanufacturerservicedepartment. Thisprocedureassumesthetechnicianperformseachstepsasindicated-leavingthemonitorinaknownstatepriortoperformingthenextstep.Ifstepsareomittedorperformedoutoforder,besurethatthemonitorissettothecorrectstatebeforecontinuing.
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Chapter4:Tests
HandheldPulseOximeterServiceManual 4-3
4.2.1EquipmentRequired 1.(4)“AA”rechargeablebatteries(fullycharged)
2.FLUKESaturationSensorSimulator,PN:1170018. 3.SpO2FingerSensor,Adult.4.2.2Procedure 1.PlugthefourfullychargedAAbatteriesintothebatterycompartment.Be
suretofollowthecorrectpolarity.Connectthebatterydoor. 2.Pressthepowerbutton.Verifytheproperpowerupsequenceisdisplayed.
Themonitorwillbeep.Andthedisplayshowssoftwarerevision. 3.Verifythedisplayshows“Sensornoconnect”.
4.TurnontheFLUKEandsetittothesettingslistedinthechartbelow.Verify
thesaturationvaluesareinthespecifiedtolerance: 5.ConnecttheFLUKEtothemonitorusingtheSpO2sensor.Setthe
ATTENUATIONto3andSATURATIONto98.6.Verifythedisplayedsaturationof96-100andapulseof75.
7.ChangetheFLUKEpowerswitchtoOFF.Verify“SensorOffline”is
displayed.8.ChangetheFLUKEpowerswitchtoON.Verifywarningmessageclearsand
asaturationandpulsevaluearedisplayed. 9.Placethefingersensoronyourfinger.Verifythemonitorisdisplayinga
saturationandpulsevaluewithnowarningmessages.
FLUKESettings MonitoringSettingsSaturation Attenuation Saturation PulseRate
98 3 96-100 75±190 3 88-92 75±180 3 78-82 75±170 3 68-72 75±1
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Chapter4:Tests
4-4 HandheldPulseOximeterServiceManual
10.Verifythepulsebarismovingupanddownsmoothly.
11.Disconnectthefingersensorfromthemonitor.Verifythemonitor
deliverstwoshortaudiobeepsevery10secondsafterthefingersensorisdisconnected.Verifythemonitorshutsoffapproximately5secondsafterthebeepingstarts.
12.TheAccuracyTestiscomplete.
4.3ElectronicTestsTheElectronicTestsverifythecalibrationandoperationoftheelectroniccircuitswithinthemonitor.ThesetestsDonotneedtobeperformedonaregular(preventative)basis.PerformthesetestsonlyifthemonitorfailstooperateasexpectedoffailstheAccuracyTestsortheFunctionalTests.The ElectronicTestsshouldbeperformedonlybyqualifiedservicepersonnel. TheElectronicTestsrequireaccesstotheinternalcomponentsofthemonitor.RefertotheMaintenancesectionfordisassemblyinstructions.CAUTION!Themonitorcontainsstaticsensitivedevices.Besuretofollow
propergroundingprocedureswhenhandlingtheinternalcomponentstoavoiddamagefromstaticdischarge.
Theprocedureassumesthetechnicianperformseachstepasindicated-leavingthemonitorinaknownstatepriortoperformingthenextstep.Ifstepsareomittedorperformedoutoforder,besurethatthemonitorissettothecorrectstatebeforecontinuing. 4.3.1EquipmentRequired1.DCPowerSupply,model:PS-305D.PN:010952932.2.DCCurrentMeter3.Multimeter.4.4“AA”2200mAhNi-MHbatteries.5.ACCharger
4.3.2Procedure1.Resistance’sTests:usetotesttheshortcircuitonthemainboard.Switch
theMultimeterto�.Therearetotal6testpoints:
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Chapter4:Tests
HandheldPulseOximeterServiceManual 4-5
2.VoltageTests:ConnecttheACchargertotheJ6onthemainboard,and
switchtheMultimetertoDCvoltage.Therearetotalfivetestpoints. 3.ElectricCurrentTestTesttheworkingcurrentofthemainboard. 1)ConnecttheDCCurrentMetertotheBAT+onthemainboard.2)HoldthepowerkeytoturnonthemonitorandplugtheSpO2sensor.3)ThereadingontheDCCurrentMetershoudbebetween100mA-300mA,
normallybetween110mA-130mA.Ifthecurrentismorethan1A,pleasecutdownthepowersupplyatonce.
Testtheshutdownelectriccurrentofthemainboard.
1)ConnecttheDCCurrentMetertotheBAT+onthemainboard.2)ThereadingontheDCCurrentMetershouldbe560μA.Itisabnormalif
thecurrentismorethan1mA.Testthechargingcurrentofthemainboard. 1)Seriesconnect4“AA”2200mAhNi-MHbatteriestotheBAT+onthemain
board.
Location ResistanceOppositeofGNDonTP1 >10K�OppositeofGNDonTP2 >500K�OppositeofGNDonTP3 >10K�OppositeofGNDonTP4 >50K�OppositeofGNDonTP10 >2.5K�OppositeofGNDonTP13 >500K�
Location NominalValue VoltageRangeTP3 3.3V 3.12V-3.48V
HoldtheSW6keyfor3second,test
TP1
3.3V 3.12V-3.48V
TP3 3.3V 3.12V-3.48VTP2 5V 4.8V-5.2VTP10 5V 4.8V-5.2V
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Chapter4:Tests
4-6 HandheldPulseOximeterServiceManual
2)SeriesconnecttheDCCurrentMeter. 3)ConnecttheACchargertoJ6ofthemainboard.ThereadingontheDC
CurrentMetershouldbe680mA.Itisabnormalifthecurrentismorethan1A.
4.ElectricTestiscomplete.
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Chapter5:Accessories
HandheldPulseOximeterServiceManual 5-1
Chapter5:Accessories5.1StandardConfiguration
CAT.NO DESCRIPTION QTY
UT100B UT100HandheldPulseOximeter EachUS10BS AdultFingerSpO2Sensor Each1615 AAsizeAlkalineBatteries Four5479 HangingStrap Each9230 OperationManual Each
5.2OptionalAccessories
CAT.NO DESCRIPTION QTY
1616 AAsizeNi-MHBatteries Four2319 HangingStrap Each1617 ACCharger Each4210 Reusablesensor,Adult,Finger Each4211 Reusablesensor,Pediatric,Finger Each4212 Reusablesensor,Neonatal/infant,Foot Each4213 Singlepatientusesensor,Adult>30kg Each4214 Singlepatientusesensor,Ped3-50kg Each4215 Singlepatientusesensor,neonatal<3kg Each3425 SpO2extensioncable Each
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Chapter5:Accessories
5-2 HandheldPulseOximeterServiceManual
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Chapter6:MaintenanceandTroubleshooting
HandheldPulseOximeterServiceManual 6-1
Chapter6:MaintenanceandTroubleshooting6.1ScheduleofMaintenanceTheelectroniccircuitswithinthepulseoximeterdonotrequirescheduledcalibrationorservice. Thepulseoximeterperformsadiagnosticself-testatpower-upthatcheckstheinternalelectronics.Ifthisself-testfailsthenormalmonitoringdisplaywillnotappear.Removetheoximeterfromuseandcontactqualifiedservicepersonnel.6.2CleaningandSterilizationTocleanand/orsterilizetheoximeteranditsaccessories:6.2.1Pulseoximeter Donotimmersetheoximeter.Donotsterilizetheoximeter.Turntheoximeteroffandupplugtheexternaladapter(ifused)fromtheACpowersourcebeforecleaning.Theoximetercanbecleanedanddisinfectedwithsolutionssuchasa70%isopropylalcohol,2%glutaraldehyde,or10%bleachsolution.Thenwipedownwithawaterdampendedcleanclothtorinse.Dobeforeuse. 6.2.2SpO2FingerSensorDonotimmersethefingersensor.Donotsterilizethefingersensor.Theoximetercanbecleanedanddisinfectedwithsolutionssuchasa70%isopropylalcohol,2%glutaraldehyde,or10%bleachsolution.Thenwipedownwithawaterdampendedcleanclothtorinse.Dobeforeuse.Makecertainthatthefingersensorwindowsarecleananddrybeforeuse.Aftercleaningthefingersensor,performaQuickChecktoverifythesensorisfunctional.CAUTION! Donotallowisopropylalcoholorwatertoenteranyofthe
openingsonthemonitor.Evidencethatliquidhasbeen
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Chapter6:MaintenanceandTroubleshooting
6-2 HandheldPulseOximeterServiceManual
allowedtoenterthemonitorvoidsthewarranty.6.3StorageWARNING! Toensureaccurateperformanceandpreventdevice
failure,donotsubjecttheUT100toextrememoisturesuchasdirectexposuretorain.Suchexposuremaycauseinaccurateperformanceordevicefailure.
Wheneverpossible,themonitorshouldbestoredatroomtemperatureinadryenvironment.Ifitisnecessarytostorethemonitorforanextendedperiodoftime,theunitshouldbepackedinitsoriginalshippingcontainer.Storingthemonitorforalongperiodoftimemaydegradethebatterycapacity.Batteriesshouldberemovedfromthemonitorbeforestoring.Storagespecificationsareasfollows:Temperature: -20oCto+55oC RelativeHumidity: 10%to95%(noncondensing)6.4AssemblyExchanges Disassemblyshouldbeperformedbyqualifiedservicepersonnelonly.6.4.1InternalAssemblies1.EnsurethatthemonitorisOFF.Removethebatterycompartmentcover
andplaceaside,removethebatteries.2.Turnthemonitoroverandremovethesixscrewsfromthebackcover3.Carefullyliftthebackandfrontcoverfromthemonitor. 4.RemovethetwobracesofLCDdisplayontheMainboardbyatweezersand
takeofftheLCDdisplaybyweldingtheFPC. 5.Theseparateassembliesofthemonitorcannowbeaccessed.
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Chapter6:MaintenanceandTroubleshooting
HandheldPulseOximeterServiceManual 6-3
Figure6.1:ExplodedStructureDrawing
6.4.2Reassemblingtheoximeter1.ReconnecttheLCDdisplayandmainboardbyweldingtheFPC.2.ReinstallthetwobracesofLCDdisplaybyatweezers.3.Seatthedisplay/mainboardassemblyintothebackcover.4.Replacethetopcoverandthesixscrews,batteriesandbattery
compartmentcover.6.3Troubleshooting Table6.1:
PROBLEM POSSIBLECAUSE CORRECTIVEACTIONNopulseshownonthebargraph.
•Patientcableorsensorisdisconnectedfromtheoximeter.•Sensorisincorrectlypositionedonthepatient.•Poorpatientperfusion.•Defectivesensororpatientcable.
•Checksensorconnectionstothepatientcableandtotheoximeter.•Repositionthesensor. •Repositionthesensor.•Tryanewsensororcontactyourauthorizedrepaircenterforhelp.
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Chapter6:MaintenanceandTroubleshooting
6-4 HandheldPulseOximeterServiceManual
Pulserateiserratic,intermittent,orincorrect.
•Sensorincorrectlypositioned.•Patientmotion
•Repositionthesensor.•Patientmustremainstilltoobtainanaccuratemeasurement.
SpO2valueiserratic,intermittent,orincorrect.
•Poorpatientperfusion. •Patientmotion.
•Repositionthesensor.•Patientmustremainstilltoobtainanaccuratemeasurement.
NoPRandSpO2values.
•Defectivesensororpatientcableormonitor.
•Tryanewsensororcontactyourauthorizedrepaircenterforhelp.
BatteryAbnormal
•Batteriesincorrectlyinstalled.•Therearenobatteries.
•Repositionbatteriescorrectly.•Equipwithoximeterwithbatteries.
Theoximeterdoesn’tturnon.
•Batteriesweak.•Batteriesnotinstalledorbatteriesincorrectlyinstalled.
•Replacethebatteries.•Ensurethebatteriesareinstalledcorrectly.
Theoximeterturnsoffunexpectedly.
•Batteriesareweakordead.
•Replacethebatteries.
Sensor
•Patientcableorsensorisdisconnectedfromtheoximeter.•Sensorisincorrectlypositionedonthepatient.•Poorpatientperfusion.•Defectivesensororpatientcable
•Checksensorconnectionstothepatientcableandtotheoximeter.•Repositionthesensor.•Repositionthesensor.•TryanewsensororcontacttheServiceDepartmentforhelp.
Table6.2:
No. PROBLEM CORRECTIVEACTION
1
LCDdisplayflasheswiththepowerindicatorwhenalarmoccurs.Thelouderthealarmvolume,thestrongeroftheflashingandviceversa.
ChecktheweldingofL26andmakeitcorrectly.
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Chapter6:MaintenanceandTroubleshooting
HandheldPulseOximeterServiceManual 6-5
2Overload of the chargingvoltageandworkingcurrent.
TesttheresistanceofR8.AddtintoU13,U12,Q5andQ8.
3CannotworkwithACchargerbutbatteries.
WeldingtheCPUagain.
4
The resistance on TP1 or TP3is short circuit and noresistance.
This is problem is caused by theshort circuit of CPU’s Pin.Welding the Pin on the weldingtableagain.
5 NovoltageonTP1andTP3. ReplaceQ9.6 ShortCircuitonTP13. ReplaceCPU.
7LCDdisplayshowsfullbatterylevelevenwithoutbatteries.
ReplaceQ10.
8
ShortCircuitbetweenTP1andGNDaswellasTP3andGND.No voltage on TP1, TP2, andTP3.
ReplaceCPU,PLCchipandU9.
9No voice after turning on themonitor
Checkthecableofspeaker.Replaceanewspeaker.
10The monitor shows “batterynormal” and the chargingcurrentis2.6~2.9A
ReplaceR51.
11
The battery level icon showsfullbatterywhenusingtheACcharger or even withoutbattery.
ReplaceQ10.
12LS2516 becoming hot whencharging.
ReplaceLS2516.
13Noresponseofthepowerkeyandsilencekey.
The PCB washing water mayleakagetothesekeys.Replaceallkeys.
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Chapter6:MaintenanceandTroubleshooting
6-6 HandheldPulseOximeterServiceManual
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Chapter7:Specifications
HandheldPulseOximeterServiceManual 7-1
Chapter7:Specification 7.1EquipmentClassificationTypeofProtectionAgainst Electricshock: Modeofoperation: DegreeofProtectionAgainstingressofLiquids: DegreeofMobility: DegreeofProtectionAgainstElectricShock: SafetyRequirements: 7.2SpO2Range: Accuracy: Resolution: DisplayResponse: 7.3PulseRateRange: Accuracy: Resolution: 7.4DefaultSettingsofAlarmsLimits
HighAlarmLimits LowAlarmLimitsAdult Pediatric Neonatal Adult Pediatric Neonatal
SpO2 99 99 99 92 92 92PR 100 110 120 60 70 80
7.5PowerRequirementsFourstandard“AA”alkalineorNi-MHcells(1.5Vdc,IECTypeLR6)
0-100%±2at70-100%<70%,undefined1%Thedisplayistofunctionalsaturation.Thepulsestrengthbargraphisnotproportionaltopulsevolume.
InternallyPoweredContinuousIPX1,dripproofHandheldTypeBFEN60601-1:1990
30-250bpm±2at30–250bpm1bpm
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Chapter7:Specifications
7-2 HandheldPulseOximeterServiceManual
7.6BatteryLifeAlkalineCells:20hours 7.7DimensionsWidth: Height: Depth: Weight: 7.8EnvironmentalSpecificationOperatingTemp.: StorageTemp.: ShippingTemp.:RelativeHumidity:
75mm(2.95inches)135mm(5.31inches)28mm(1.10inches)258grams(9.10ounces)withbatteries
0to45℃-20to+55℃-40to+55℃30to95%(operating)10to95%(storage)0to95%(shipping)
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Chapter8:Drawings
HandheldPulseOximeterServiceManual 8-1
Chapter8:Drawings
No. Description 1 ExplodedStructureDrawing2 Schematic,MainBoard3 Schematic,Power4 Schematic,BatteryCharger5 Schematic,Acceleration6 Schematic,Key
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Chapter8:Drawings
8-2 HandheldPulseOximeterServiceManual
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3rdfloor,NO.39,JinqiaoRoad,
Zhangjiawan,ShapingbaDistrict,
Chongqing,China Phone (+86)23-6172-8390
Fax (+86)23-6172-8391
E-mail [email protected]
Website www.chinautech.com