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UT100HandheldPulseOximeter

ServiceManual

-EnglishVersion1.0,June2011

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

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

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

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: service@chinautech.comWebsite:http://www.chinautech.com

Chapter2:GeneralDescription

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

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.

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)

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:

“ ”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.

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.

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.

Thispageisintentionallyleftblank.

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.

Chapter3:ControlsandFeatures

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).

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.

Chapter3:ControlsandFeatures

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.

Chapter4:Tests

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

Chapter4:Tests

“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.

Chapter4:Tests

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

Chapter4:Tests

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:

Chapter4:Tests

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

3.3V 3.12V-3.48V

TP3 3.3V 3.12V-3.48VTP2 5V 4.8V-5.2VTP10 5V 4.8V-5.2V

Chapter4:Tests

2)SeriesconnecttheDCCurrentMeter. 3)ConnecttheACchargertoJ6ofthemainboard.ThereadingontheDC

CurrentMetershouldbe680mA.Itisabnormalifthecurrentismorethan1A.

4.ElectricTestiscomplete.

Chapter5:Accessories

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

Chapter5:Accessories

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Chapter6:MaintenanceandTroubleshooting

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

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.

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.

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

LCDdisplayflasheswiththepowerindicatorwhenalarmoccurs.Thelouderthealarmvolume,thestrongeroftheflashingandviceversa.

ChecktheweldingofL26andmakeitcorrectly.

2Overload of the chargingvoltageandworkingcurrent.

TesttheresistanceofR8.AddtintoU13,U12,Q5andQ8.

3CannotworkwithACchargerbutbatteries.

WeldingtheCPUagain.

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.

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.

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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Chapter7:Specifications

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

Chapter7:Specifications

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)

Chapter8:Drawings

No. Description 1 ExplodedStructureDrawing2 Schematic,MainBoard3 Schematic,Power4 Schematic,BatteryCharger5 Schematic,Acceleration6 Schematic,Key

Chapter8:Drawings

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Chongqing,China Phone (+86)23-6172-8390

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