HINGMED WBP-03D User manual

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CE0120
Hingmed
WearableAmbulatoryBloodPressureMonitor
UserManual
(Applyto：WBP-03Dforhomeuse)
ShenzhenHingmedMedicalInstrumentCo.,Ltd.
VER：A/0
Date:March15,2015

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AboutthisManual
Themanualmainlyintroducestheinstallationandapplicationmethodof
WearableAmbulatoryBloodPressureMonitor.Usersshouldread
carefullybeforeapplication(includewarnings,contraindicationsand
notes).
ManufacturerShenzhenHingmedMedicalInstrumentCo.,Ltd.
Manufacturingaddress:4thFloor,ZhonghangfeixiangBuilding,NO.371,
Guangshen Road, Bao’an District, Shenzhen, People’s Republic of
China
Tel:[phone]
Fax:[phone]
Postcode:518102
After-salesservice
Company:ShenzhenHingmedInstrumentsCo.,Ltd.
Address:4thFloor,ZhonghangfeixiangBuilding,NO.371,Guangshen
Road, Bao’an District, Shenzhen, People’s Republic of China
Tel:[phone]
Fax:[phone]
Postcode:518102
EuropeanRepresentative
CompanyName:WellKangLimited
CompanyAddress:TheBlackChurch,St.Mary'sPlace,Dublin7,
Ireland
Tel:[phone]
Fax:[phone]
Web:www.CE-marking.com
Email:[e-mail]
VersionInformation
Thismanualmayupgradeduetosoftwareupgrading.Userwillnotbenotified
further.
■Version:A/0
■Issuedate:March2015
ShenzhenHingmedMedicalInstrumentsCo.,Ltd.ownsandreservesthe
copyright.

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TableofContent
Chapter1Preface..................................................................................................................5
1.1BriefIntroductiontoAmbulatoryBloodPressureMonitoring...................................5
Chapter2SafetyRequirements............................................................................................7
2.1Intendeduse.............................................................................................................7
2.2Contraindication........................................................................................................8
2.3Warnings...................................................................................................................8
2.4Notice........................................................................................................................9
2.4.1Battery............................................................................................................9
2.4.2Bloodpressuremeasurement........................................................................9
2.4.4Energyconservationandenvironmentprotection.........................................9
2.4.5Maintenance...................................................................................................9
Chapter3ProductIntroduction...........................................................................................10
3.1Productcomposition:.............................................................................................10
3.2NameandFunctionofEachComponent..............................................................10
3.2.1HostIntroduction.........................................................................................10
3.2.2OLEDscreendisplaysandiconimplication.................................................11
3.2.3Symbols........................................................................................................11
Chapter4ProductInstallationandUse..............................................................................12
4.1Batteryinstallation.................................................................................................12
4.2Wearthemonitor...................................................................................................12
4.2.1Wearcuffcorrectly......................................................................................12
4.2.2Startforsinglemeasurement......................................................................12
4.2.3Readyforuse..............................................................................................12
4.3InstallingSystem(PCterminal).............................................................................13
4.3.1Hardwarerequirements...................................................错误！未定义书签。
4.3.2Softwarerequirements....................................................错误！未定义书签。
4.3.3Installthesoftware..........................................................错误！未定义书签。
4.4ExecuteAmbulatoryBloodPressureStudy(PCterminal)........错误！未定义书签。
4.4.1CommunicationwithHingmedABPM.............................错误！未定义书签。
4.4.2Connectmonitortocomputer..........................................错误！未定义书签。
4.4.3Continuousmeasurementprogramming........................错误！未定义书签。
4.4.4Startmonitoring...............................................................错误！未定义书签。
4.4.5Finishmeasuring.............................................................错误！未定义书签。
4.4.6Derivedata......................................................................错误！未定义书签。
4.5Installsystem(Smartmobileterminal)..................................................................13
4.5.1Hardwarerequirements:..............................................................................13
4.5.2Installationofsoftware.................................................................................13
4.5.3TheBluetoothmatchingandconnection............................................................13
4.6ExecuteAmbulatoryBloodPressurestudy(Smartmobileterminal)....................14
4.6.1CommunicatewithHouseholdAmbulatoryBloodPressureMonitor..........14
4.6.2ProgramAmbulatoryBloodPressureMonitorsoftware..............................14
4.6.3Startambulatorybloodpressuremeasurement..........................................14

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4.6.4Storeandextractmeasurementdata..........................................................15
4.6.5Finishmeasurementanddataderive..........................................................15
Chapter5TroubleshootingandMaintenance....................................................................15
5.1Troubleshooting.....................................................................................................15
5.2Maintenance..........................................................................................................16
5.2.1Maintenanceinspectionandsafetymanagement......................................16
5.2.2HostMaintenance.......................................................................................16
Chapter6Productspecifications........................................................................................18
Chapter7EMCinformation................................................................................................19
Chapter8WarrantyCard....................................................................................................23

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Chapter1Preface
1.1BriefIntroductiontoAmbulatoryBloodPressureMonitoring
Ambulatorybloodpressuremonitoringisaninstrumentformonitoringhuman’sblood
pressurecontinuouslyduringcertainperiod(normally1-2days)withcertainintervalthat
isbasedonactualsituation.Bloodpressurereadingsindifferentperiodsandunder
differentlifeconditionscanbejudgedaccordingtothemeasuringresults,thusblood
pressurediagnosiswouldbegiven.
During24hoursinaday,humanbloodpressureisnotfixedbutfluctuateswithinacertain
scope.Thediagnosismadebyclinicalbloodpressuredatacollectedrandomlyin
sickroommaymisssomepatientwhosebloodpressureisabnormalinacertainperiodin
awholedayduetoneglectingthefluctuationofbloodpressure.The24-hourambulatory
bloodpressuremonitoringcandetectthosepatientsintime.
Itisalsoimportanttoconduct24-hourambulatorybloodpressuremeasuringforthose
patientswhowerediagnosedhyperpietic.Researchshowshalfofhyperpieticpatients
whobelievetheirbloodpressureswerecontrolledwellhaveunstablebloodpressures
through24-hourambulatorybloodpressuremonitoring,theirbloodpressuresriseupin
themorningand/orintheafternoon,orrisesupatnight,sotheirbloodpressure
controllingmeasuresarenotideal.Thatisoneoftheanswerstothatwhysome
hypertensionpatientswhosticktotakemedicineandfeelgoodinbloodpressurescontrol
stillsufferfromrenaldamage.24-hourambulatorybloodpressuremonitoringcanhelp
patientstorealizetherulesandcharactersoftheirbloodpressurefluctuation.Accordingly,
patientscouldtakeshort,mediumorlong-termantihypertensivedrugstocontroltheir
bloodpressureandavoiddamageoftargetorganse.g.cardio,brainandkidney.
Obviously,Ambulatorybloodpressuremonitoringissuperiortoclinicalbloodpressure
measurement,andgraduallybecomesanimportantmethodtoevaluatethetreatment
effectofant-hypertensiongradually.
Comparetoclinicalorhomeoccasionalbloodpressuremeasuring,theambulatoryblood
pressuremonitoringissuperiorinthefollowingaspects:
(1)Eliminatethecontingencyinmeasuringandsomeaffectingfactorsi.emood,sports,
food,smoking,drinking,andothers.
(2)Couldattainmorebloodpressuredatathatcouldreflectpracticalvariationrule
duringawholeday.
(3)Couldincreasedetectionrateandhelpthoseslightorborderlinehypertension
patientstogettimelytreatment,thesepatientsmayhavenotanysymptomatearlystage.
(4)Mayusedtoguidedrugtherapy.Inmanycasesitcouldbeusedtoevaluatedrug
treatmenteffect,helptoselectdrugs,andadjustdosageanddrugadministrationtime.
(5)Tojudgeifthereweretargetorgansdamage(especiallyorganswhichare
susceptibletohypertension).Forthehypertensionpatientswithmyocardialhypertrophy,
fundusdynamicvascularlesionsorrenalfunctionchange,thebloodpressurevalues
betweendayandnightareusuallysmall.
(6)Topredictthetimeofsuddenattackofcardiovascularandcerebrovasculardiseasein
aday.Generally,itismostfrequentthatbeforedawnthediseaseattacksduetoa
suddenbloodpressurerising.
(7)Ambulatorybloodpressurehasanimportantsignificanceforprognosis.Comparewith
normalbloodpressure,patientswithhighbloodpressurein24hourshavehigher
mortalityandincidenceofcardiovasculardiseasethanthosewithlowbloodpressurein
24hours.

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Forthefollowinghypertensiontypes,itisonlyambulatorybloodpressuremonitoringthat
coulddiagnoseeasily.
1.white-coathypertension
White-coathypertensionisthebloodpressurethatishighwhenmeasuredathealthcare
sitebutnormalindailyactivity.Thehighpressureathealthcaresiteisrepeatablein
differentdays.Thewhite-coathypertensionaccountsforabout15%inallclinicpatients,it
isnotrare.
2.Maskedhypertension
Maskedhypertensionisthattheclinicalmeasuringvalueislessthanthestandard,but
thevaluefromambulatorybloodpressuremonitoringishigh(135/85mmHg).Itis
reportedthatpopulationofmaskedhypertensionaccountsforabout10%ofthegeneral
crowdandabout40%ofthepatientsundergoingantihypertensivetherapy.Ithastoapply
ambulatorybloodpressuremonitoringonthosemaskedhypertensionpatientswhoare
undergoingantihypertensivetreatment.
3.Morningpeakhypertension
Morningpeakhypertensionisdefinedthattheaverageofmatutinalbloodpressureis
morethan135/85mmHg.Itmaybedividedinto2types-"matutinalpeak"and
"reverse-dippers/nondipper".Themorningpeaktypeischaracterizedbysuddenriseof
bloodpressureearlyinthemorning,andthereverse-dipper/non-dipperischaracterized
bycontinuousriseofbloodpressureinearlymorningandatnight.Bothofthemarethe
riskfactorsofcardiovasculardisease.ABPMcanidentifythetwotypesofhypertension.
4.Largecircadianrhythmofbloodpressure
Thecircadianrhythmofbloodpressureissubjecttorelationshipofdaytimeblood
pressureandnighttimebloodpressure.Indaytimepatientsareactiveandinnighttime
patientsaresleeping,itisalsoinfluencedbyexternalcauses(i.e.sleep-wakecycle)and
internalcause(i.e.biologicalclock).Specificcircadianrhythmvariabilityistheaverage
changerateofbloodpressureduringnighttimeanddaytime.Althoughthecircadian
rhythmiscommonfornormalpeopleandprimaryhypertensionpatients,somespecial
hypertensionpatientsorfewprimaryhypertensionpatientsmayoccurdisorder,
disappearance,evenreversiontocircadianrhythm.
5.Secondaryhypertension
Circadianrhythmvariabilityofsecondaryhypertensionpatientsmaybedisturbed.
Becausethedisturbedcircadianrhythmvariabilityonsecondaryhypertensionpatients
mayplayaroleonthetargetorgandamageprogress,anappropriateantihypertensive
treatmentstrategyshouldbemadetorecognizethecircadianrhythmvariability.
6.Hypotension
Ambulatorybloodpressuremonitoringisveryusefulnotonlytodiagnosehypertension
butalsodiagnosehypotension.Especially,thehypotensioncouldcausedizzinessor
faintingonelderpeoplewhohaveexhaustionofautonomicnervouswhenstanding,after
amealorafterabath.
Hypotensionisdividedintoprimaryhypotensionandsecondaryhypotension.Primary
hypotensioniscommoninwomen,whichcouldreducethepatient'slifequalityusually.
However,justfewprimaryhypotensionswillbetreatedconsideringlong-termprognosis,
becauseprimaryhypotensionjustleadstofewvasculardisorders.Ontheotherhand,
secondaryhypotensionisusuallycausedbysomenormaldiseasesandisaccompanied
withdangeroussyndromessuchassyncopeandvertigo,sopatientsneedprevention
andtherapeuticmeasures.Theambulatorybloodpressuremonitoringisusefulto
diagnosesecondaryhypotension.

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1.2BriefIntroductionofHingmedWearableABPM
BloodPressureMonitorwithBodyPositionInformation
Hingmedambulatorybloodpressuremonitorhasanoutstandingfeaturethatitcould
providetheuser'sbodypositionwhentakingbloodpressuremeasurement,whichisof
significanceinclinicalresearch.Somesymptomsofhypertensivepatients,suchas
dizziness,nausea,braindeath,arecausedunderdynamicenvironmentofworkingor
otherlife.Therefore,monitoring patient’s blood pressure couldnotbeconfinedtoaquiet
condition.Itisthebestthatpatientswhoarewearingambulatorybloodpressuremonitor
liveadailylifeandwork.Thedatawouldreflecttheactualdailybloodpressure.Thatis
helpfultoclinicaljudgments.
Differentpostureshaveagreatinfluenceonbloodpressure.24-hourmonitoringshows
thebloodpressureisfluctuantatdistincttime.Ifamonitorcanreflecttheuser'sposition
atthesametime,itwouldbehelpfulfordoctorstofindthecausesofthebloodpressure
fluctuations,andthendistinguisheffectivelynaturalchange,fluctuationorfluctuation
causedbypositionchangingandmoving.
Inaddition,bloodpressuredatawithpositioninformationcanhelpdoctorstomakea
goodjudgmentonorthostatichypertension.Positionhypertensionisthatthepressureis
highatstandingorsittingposture,butnormalatlyingflat.Orthostatichypertension
accountsfor4.2%indomestichypertensionpatientsand10%inabroadreport.
Orthostatichypertensionischaracterizedbythatthereisnothypertensioninnormaland
justbeingfoundoccasionallyorinphysicalexamination.Diastolicpressurerising-upand
largefluctuationwouldrepresentinorthostatichypertensionandtheindividualcouldbe
accompaniedbyseriouspalpitation,tiredness,sleepquicklyetc.Inbloodexamination,
theplasmarenninactivityinorthostatichypertensionishigherthanthatofnormalpeople,
eventhanthatofgeneralhypertensionpatient.
Scopeofapplication
HingmedAmbulatorybloodpressuremonitorisdesignedtoassistindiagnosis.Doctor
couldgiveadvicetousethismedicaldevicebyhisorherjudgmentifpatientis:
●Hypertension;
●Hypotension;
●Borderlinehypertensive(BH),renalinadequacy;
●Controlandevaluatetheanti-hypertensionefficacy,etc.
Chapter2SafetyRequirements
2.1Intendeduse
WearableBloodpressuremonitorismainlyusedtomeasurebloodpressures,which
includesystolicpressure,diastolicpressureandpulserate,ofpatientsindifferentsetting
intervalswithin24hours(notapplicabletochildrenunder3years),andthemeasurement
datacanbetransmittedbyBluetoothformedicalpersonnel’sreferenceandanalysisat
homeorintheopenair.

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Productcomposition:Mainunit,Noninvasivebloodpressurecuff,USBdatawireand
HingmedPCsoftware.
ThedeviceisinnerpowersourcewithonepieceofLithiumbattery;Electricshock
protectiondegree:CFtypeappliedpart;Operationmode:continuousmode.
Theservicelifeofthisproductisfiveyears.
2.2Contraindication
●DonotusethemonitornearX-raytomographydevice.
●Donotusethemonitorintheplaceswhereinflammableanestheticexist,itmayleadto
explode.
●DonotwrapthecuffonthelimbbeingusedforIVinjectionascuffinflationmayblock
infusionandhurtpatient.
●Donotimmersethemonitorinanyliquidoranydetergent,whichwouldcauseelectrical
hazard.
2.3Warnings
●Cuffshallnotbewornonthewound,becauseinflationpressuremaycausefurther
damage;
●Whenpatientscarrythemonitor,pulloutthedatawirefromPCorotherdevices;
●Neverapplythedevicetopatientunder3yearsoldand patient who can’texpresstheir
thoughts.
●The instrument can’t be used in conjunction with defibrillation equipment.
●Itmaycausemeasurementerrorbyusingpartsnotincludedinthesupplylisting.
●Makesurethepressureissuitableforthepatient.Ifanyabnormityoccursinthe
monitoringprocess,pleasestopmeasuringimmediately,andremovethecufffromthe
patientorshortlypressstart/stopbuttontostopinflating.Ifthecufffailstodeflate,
pleaseremoveitproperlyandsafely.
●Ifthisdeviceisdampenedbyaccident,putitinawell-ventilatedplacefordryingpriorto
use.
●Onlyprofessionalphysicianscanexplainthemeasuredbloodpressurevalues.
●Don’tservice/maintenancewhilethemedicalequipmentisinuse
●Thepatientisanintendedoperator.Thepatientcanonlymeasure,transmitdataunder
normalcircumstancesandmaintainthedeviceanditsaccessoriesaccordingtothe
UserManual.
●Notintendedtobesterilized.
●Notforuseinanoxygenrichenvironment.
●Nomodificationofthisequipmentisallowed.
●Itisnotintendedforusewithneonate.
●Itisnotintendedforusewithpregnantorpre-eclampticpatients.
●Donotapplythecuffoverawound;otherwiseitcancausefurtherinjury.
●Theapplicationofthecuffanditspressurizationonanywrist/armwhereintravascular
accessortherapy,oranarterio-venous(A-V)shunt,ispresent.

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●Inflatethecuffonthesideofamastectomy.
●DonotinflatethecuffonthesamelimbwhichothermonitoringMEequipmentis
appliedaroundsimultaneously,becausethiscouldcausetemporarylossoffunctionof
thosesimultaneously-usedmonitoringMEequipment.
●Pleasecheckthatoperationofthedevicedoesnotresultinprolongedimpairmentof
patientbloodcirculation.
●ThedevicecannotbeusedwithHFsurgicalequipmentatthesametime.
●Keepoutofthereachofchildrenafteruse.
2.4Notice
2.4.1Battery
●Themonitorusesbuilt-inbattery,donotreplaceitwithoutauthorization.
●ConnectmonitorhosttocomputerUSBportthroughUSBdatawireforrecharging,
alternatively,connecthosttoUSBportofadapter,andthenconnectadaptertopower
socketforrecharging.Theadaptershouldbewith3Ccompulsorycertificationorother
compulsorycertifications(suchasFCCorCE).Thespecificationsofadaptershouldbe:
input:100-240V,50/60HZ;output:5V,1A.
●Keepthemonitorawayfromhigh-temperatureplaces,andavoiddirect-sunlightin
summer,also,theenvironmentaltemperatureshallnotbeover60Celsiusdegree.
●Forsecurity,consultafter-salesupporterquickly,iftheLi-ioncannotbechargedorits
dischargespeedisfast.
2.4.2Bloodpressuremeasurement
●Patientwithanticoagulantorpatientwithcoagulationdisordermayextravasateonthe
positionwrappingcuff,intheprocessofmeasuringbloodpressureeventhecuffis
worncorrectly.Infact,nomatterwhattypeofthemonitoris,suchpatientswould
extravasateduringthemeasuringprocess.
●Ifcufffailstoinflatein150seconds,guidepatientstoremovethecuffmanually,
excessiveinflationmayblockpatient'sbloodflowthatmakespatientuncomfortable.
●Keepstillduringmeasuring,especiallydonotmovetheircuffedarms,anditisbetterto
keepquiet,andmakethecuffasthesamehorizontalpositionastheheart.
●Operatingorstoringthemonitorbeyondthespecifiedenvironmentalconditionsin
Chapter6wouldcausedamage.
2.4.4Energyconservationandenvironmentprotection
●Pleasepowerthemonitoroffintimeafterusing.
●Pleaseproperlyhandlethescrappedbatteries,cuff,datawiresandmainunitsin
compliancewithlocalenvironmentalregulations.
2.4.5Maintenance
●PleaseusetheaccessoriessuppliedbyHingmed,otherwiseitmaycausemeasuring
errors.
●Maintenanceshouldbeconductedonlybytrainedpersonnelorpersonnelauthorized
byHingmed.
●Displayingmethodoffaults:correspondingcodeswilldisplayonthescreenin
malfunctionstate,see5.1troubleshootingfordetails.

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Chapter3ProductIntroduction
3.1Productcomposition:
Priortousepleaseconfirmifaccessoriesarecomplete,andifthereisanydamageon
mainunitandaccessories,anyproblemaboveisfound,pleasecontactdistributorsor
Hingmedcustomerservicehotlineforhelp.
Mainunit,accessoriesincludebloodpressurecuff,andUSBwireforcharging.
Otheraccessories:
UserManual
QualityCertification/warrantycard
HingmedABPMPackingList
AccessoriesItemsNameQty
HingmedWearableABPMMonitor1
Portableboxformonitor1
USBdatawire1
Adultcuff(26-36cm)1
UserManual1
QualityCertification1
*Theproductpackagingshouldcontainaboveitems,anyitemmisses,pleasecontact
Hingmedordistributorsimmediately.
Optionalaccessories
NumberAccessoriesName
1SmallAdultcuff(18-26cm)
2MiddleAdultcuff(22-32cm)
3LargeAdultcuff(33-43cm)
3.2NameandFunctionofEachComponent
3.2.1HostIntroduction
1
2
3
4
5
6

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1OLEDscreen;2Cuff;3Backwardbutton;4Poweron/offbutton(Closingstate)and
Start/stopbutton(Openstate);5Forwardbutton;6USBport.
3.2.2OLEDscreendisplaysandiconimplication
Diastolicpressure
Systolicpressure
Diastolicandsystolicpressurevaluesindicated
aftermeasuring
Unitofdiastolicandsystolicpressure
Heartratevalueindicatedaftermeasuring
Heartrateunit(timesperminute)
Indicatecurrenttimewhennotmeasuring,after
poweringon.
indicatebatterycapacity
3.2.3Symbols
SymbolDescriptionSymbolDescription
CFtypeappliedpartSeriesnumber
ManufacturerAttention,referto
accompanyingdocuments
Keepawayfromrain
Thiswayup
Fragile
ComplyingwithWEEE
standard
Stackinglimitby
number
Temperaturelimits
Refertousermanual
Itmeansthedevicecould
protectedagainstsolidforeign
objectsof12.5mmand
greater,andagainstvertical
fallingwaterdrop15°

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Chapter4ProductInstallationandUse
4.1Batteryinstallation
Themonitoradoptsbuilt-inLi-ionbatterywhichisunable-dismantled,anddonotreplaceit
withoutauthorization,whenthecapacityofbatteryisgoingtorunout,pleaserechargethe
monitorbyusingUSB.
4.2Wearthemonitor
HingmedwearableABPMisintegrationdesign,itsuggestswearingthecuffonleftarm,
clickthepoweron/offbutton(themiddlebutton)toopenthemonitor,andpressitforabout
5secondstoclosethemonitor.
4.2.1Wearcuffcorrectly
Wearcuffcorrectly,thebottomofthecuffshouldbe2-3cmabove
thefossacubitalia.Makesurethatthearterysignisagainst
thearterybrachialisandpointstofossacubitalis,adjusttheposition
ofmonitortooutsideplace,seethepictureright:
Note:1Impropersizeofcuffwillleadtoerrorofreadingsand
affecttheaccuracyofmeasuring.
2.Donotwrapthecuffonthediseasedskindirectly,
wrapapartitionlikeclothorfilmbeforewrappingthe
cuff,toavoidcross-infection.
4.2.2Startforsinglemeasurement
Press “start/stop” button to start measuring(themiddlebutton),it
onlymeasuresforonetime,aftermeasuring,usercanreadthedataonOLEDscreen,
also,usercanclickforwardbuttonorbackwardbuttontoreadhistorydata.
Forprogrammingmeasurement,pleaserefertosections4.3-4.4ofthisusermanual.
4.2.3Readyforuse
Forambulatorybloodpressurestudy,agoodpreparationofpatientisimportant.
● Patient should avoid overstress, excitement and tightened muscle.
● When start inflating, patient should keep the measuring arm away from body slightly,
andkeepquietandstillassoonaspossible.
● During programming monitoring, patient may press the button of “start/stop” to
start/stopmeasuringatanytime.
● Never remove the cuff in the process of measuring, if the cuff slips below the elbow or
fallsoff,patientcouldtakeitoffandrewrap.
● Datawouldnotbelostifbatteryisrundown,ormonitoringprogramisinterrupted,or,
monitorismanuallyforceclosed.
●Guidepatienttorecordtheeventsthataffectbodypositionobviouslyduringmeasuring;
● Make sure that patient know how to check the monitor. The monitorshouldbedryand
avoidfallingandbumping.
● If monitor or cuff causes excessive pain or abnormal pain, patient should remove the

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cuffandpoweroffthemonitor.
4.3Installsystem(Smartmobileterminal)
4.3.1Hardwarerequirements:
Operatingsystemrequirements：Androidsystem2.3.1orhigherversions，AppleIOS
systemIOS6.0orhigherversions.
Handholdterminalrequirements:Iphone4SoraboveversionsforApplemobilephone,
IpadMini,Ipad3orhigherversions,IpadTouch5orhigherversions;Withhandhold
terminalofAndroidsystem,e.g.Samsung,Lenovo,Huawei,Xiaomi,Coolpadphonewith
480X800oraboveresolutionofthedisplayscreen
Memoryrequirements:softwaresizeisabout1.64Mandneedabout3.74Minstalling
EMSmemory.
4.3.2Installationofsoftware
ForAndroidsystemhandholdterminal,userscouldlogon
Hingmedwebsitehttp://www.hingmed.comorAndroidAPP
platform,download and install “Hingmed blood pressure”
software.
ForAppleIOSsystemhandholdterminal,UserslogonApp
Store, download and install “Hingmed blood pressure” software.
Theiconappearsonthescreenofhandholdterminal
meansasuccessfulsoftwareinstallation.
4.3.3TheBluetoothmatchingandconnection
For Android phone, enter “Setting”---“Bluetooth”(atthetime,keeptheBluetoothof
monitoropen),searchtheBluetoothofmonitor(“Hingmed WBP”) and make pairing. Click
to open software APP and enter “More” ---“Bluetooth setting”and choose “Hingmed
WBP” to connect monitor and mobile phone. After successfulconnection,clicktoexit
andclick”Measurement”tologinmeasurementinterface.SeeFig4.
For Apple phone, open software App directly and enter “More” ---“Bluetooth setting”and
choose “Hingmed WBP” to connect monitor and mobile phone.Aftersuccessful
connection,clicktoexitandclick”Measurement”tologinmeasurementinterface.
SeeFig4.
Fig4

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4.4ExecuteAmbulatoryBloodPressurestudy(Smartmobile
terminal).
4.4.1CommunicatewithHouseholdAmbulatoryBloodPressureMonitor
ConnectmonitorandhandholdterminalthroughBluetooth,programthesoftwareof
handholdterminalandstartmonitoringtoexecute24-hourAmbulatoryBloodPressure
study.Monitorwillmeasurethepressureaccordingtothesetinterval.
4.4.2ProgramAmbulatoryBloodPressureMonitorsoftware
Programsoftwareaftersuccessfulconnectionasfollowings:
Clickontoprightoenterprogramminginterface(seeFig5).UsercouldsetDaytime
/nighttimemeasurementmodel,monitoringfrequency,time
andmaximuminflationpressurebyslidingorclickingthe
interface.
Parametersetting:
1.Daytime/nighttimecontinuousmeasurementinterval:Define
starttime,endtimeandmeasurementintervalindaytimeor
nighttime.Thedatawillbestoredautomaticallyintermwiththe
definedtime.
2.Measurementinterval:measurementintervalisthetimeof
twosuccessivemeasurements.Theoptionsmaybe15,30,45,
60,90,and120(min).
3.Maximuminflationpressure:Maximuminflationpressureisthemaximumoneina
measurement.Usuallytherangeissetfrom200mmHgto280mmHg.Possiblemaximum
systolicpressureplus40mmHgisrecommended.Theactualinflationpressuresetting
shouldnotreachuptothemaximumpressure,whichmaycauseuserdiscomfort.You
cansetthepressurewithlastmeasurementplus40mmHg.ThesettingofMaximum
inflationpressureisforprotectingfewuserswhocouldnotbearexcessivecuffpressure.
4.Fill in or choose other options truthfully and click “Program” to upload these setting to
monitor. Screen will display “Successful programming” if the programming is
accomplished.
4.4.3Startambulatorybloodpressuremeasurement
Aftersuccessfulsoftwareprogramming,clickthebuttononmonitortostartthefirst
measurement.Themonitorwillperformfollowingmeasurementstilltotheendtime
according to the setting. Data will be stored automatically and user could click “Statistic”
and “History” to review the history data and chart or send the information to medical staff
byE-mailforfurtheranalysis.
Fig5

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4.4.4Storeandretrievemeasuringdata
IfkeepingconnectionbetweenmonitorandhandholdterminalthroughBluetooth,the
datawillbetransmittedtohandholdterminalcontinuouslyfrommonitor.IfBluetoothis
disconnectedandreconnected,thelostdatawillbetransmittedautomatically.
Usercanclick “Data backup” on “More” interface to backup the data on SD card(Note:
IOSsystemhasnotthisfunction).
4.4.5Finishmeasurementanddataderive
Press“start/stop”buttonfor5secondstofinishmeasurementifuserwantstofinishthe
measurementbeforeendtime.PowerindicatorlightofhostandthelightofBluetooth
alsoclose.
Note:
1.OperationdetailsofMobilephonesoftwareofHingmedWearableAmbulatory
BloodPressureMonitor,pleasereferto<UserGuideofAPPsoftware>;
2.Themonitorcouldstoremaximum300hundredrecords.Whenstorageisfull,
the monitor can’t savedatanormallyuntilprogrammingitfromsmartmobile
phone.
Chapter5TroubleshootingandMaintenance
5.1Troubleshooting
E
rror
CodeDescriptionResolution
EC01Cuffistooloose,maybeloosewindingor
disconnectedcuff
Retightencufforkeepproperarm
positionwheninflation
EC02Airleakage,maybevalveleakageorgas
pathleakage
Tightenmetalconnectorandcheck
thecuff.Ifleakageisnotstill
resolved,contactagentordealer
EC03Airpressureerror,maybeunabletoopenof
valveCheckwhetherthevalvecanwork normally
EC04weaksignal，maybeweekpulseorloose
cuff
Checkwhetherthecuffistooloose,
tightenitifnecessary.
EC05beyondthelimit，maybethepressureof
subjectbeyondthelimitation
Press “start/stop”buttontomeasure
again.Ifnotvalidstill,changethe
monitoroflargerrang
EC06Excessiveexercise，maybethereistoo
muchmotionartifactorinterferenceKeepquietwhenmeasuredanddo
notmovethearmwithcuff
EC07overpressure，cuffpressurebeyond
290mmHginadultmode,247mmHginchild
modeand145mmHginneonatalmode
Press “start/stop”buttontomeasure
again.

16
EC08Signalsaturation，Theamplitudeofthe
signalistoolargeduetoactivityorother
reason
Keep quiet, Press “start/stop”button
tomeasureagain.
EC09overtime：measuringtimebeyond120sin
adult/childmode,90sinneonatalmode.
Keep quiet, Press “start/stop”button
tomeasureagain.
EC10manualde-activationKeep quiet, Press “start/stop”button
tomeasureagain.
EC11SystemerrorRestart，Iftheerroroccurfrequently,
professionalMaintenancemaybe
necessary
EC16Cuffpressurebeyondthemaxpressure
setting
ReprogramminginPCsoftwareand
up-regulatethemaxinflation
pressuresetting
EC32ThehandshakecommunicationfailPress “start/stop”buttontomeasure
again.
EC33safepressurebeyond15mmHg，
immeasurable
Gassingandremeasurewhenthe
cuffpressuredeclinetobelow
15mmHg
EC34Measurementfinish,andrestartthe measuringwhenthepressureisstillabove
15mmHg
Gassingandremeasurewhenthe
cuffpressuredeclinetobelow
15mmHg
EC35Noanswerwhenthemeasurement
commandissent.Press “start/stop”buttontomeasure again.
EC36MeasurementresultisnotavailablePress “start/stop”buttontomeasure
again.
EC37Overtime(beyond180s)remeasure
EC48Memoryisfull,cannolongermeasureUploadandemptythedata
*Iftheerrorscanberevised,pleasecalldistributororafter-saledepartmentofHingmed
forhelp.
5.2Maintenance
5.2.1Maintenanceinspectionandsafetymanagement
Visuallyinspectthebrokenordamagesonenclosureandcuff.Ifanydamageisfound,
donotusethemonitor.Pleasecontactthedistributorortheafter-saleservicedepartment
ofHingmed.
5.2.2HostMaintenance
Afteruse,itisimportanttoperformpreventativemaintenancetoensurethesafeand
efficientoperationofthemonitorforlong-term.
●Itisrecommendedthattheperformanceshouldbecheckedevery2yearsandafter
maintenanceandrepair,byretestingatleasttherequirementsinlimitsoftheerrorofthe
cuffpressureindicationandAirleakage(testingatleastat50mmHgand200mmHg).
●Donotdisinfect.DONOTimmersethemonitorinanyfluid,orattempttocleanwithany
liquiddetergents,cleaningagents,orsolvents.Youmayuseasoft,dampclothtoremove
dirtanddustfromthemonitor.Iftheunitdoesbecomeimmersedinwater,donotuse
andcontactthedistributororourservicedepartment.

17
●Donotcleantheenclosureandcuffwithstrongalkalioracidorstrongdisinfectant.
●Mayuseamilddetergenttocleanthecuff,beltandbladder;alternatively,mayalso
washtheminawashingmachine.Removethebladderfromthecuffbeforemachine
washing.Washthembyusingwarmwaterandamilddetergent,thenhangitfordrying.
Anyproblem,pleasecontactlocaldistributorsorHingmed(seeChapter8for
information).
●Takedownthemonitorfromthecuff,useamilddetergenttocleanthecuffandbladder,
removethebladder(withfixingboardonit)fromthecuffbeforewashing,thenhangthem
fordrying.Afterdrying,putthebladderintothecuff,theninstallthemonitorontothecuff.
Seethefollowingstepstotakedownthecuff:
a)Dismantle
NO.
PictureDescriptionNO.
PictureDescription
1
Holdthepositions
showninthe
picture,andgive
forcebyfollowing
theredarrows.
2
Pulloutthetop
twofixingclips
3
Thenmovedown
alongtheunit,hold
thepositionsshown
inthepicture,and
giveforceby
followingthered
arrows.
4Pulloutthe
middletwo
fixingclips
5
Holdthesame
positionsinstep3,
andgiveforceby
followingthered
arrow.
6Thenthemain
unitandthe
cuffare
detached.
b)Assemble
NO.
PictureDescriptionNO.
PictureDescription
1
Putthebottom
fixingclipand
minimizedhoseinto
relevantholes,and
pushtheunitby
followingthered
arrow.
2
Thebottom
fixingclipand
hoseare
pressedinto
place.

18
3
Holdthepositions
showninthe
picture,andpress
simultaneously,then
pressaroundthe
edgesofmainunit
4
Themonitoris
installedwell
Chapter6Productspecifications
NameWearableAmbulatoryBloodPressureMonitor
ModelWBP-03D
measuringmethodOscillometricmethod
Systolicbloodpressure
measurementrange40-260mmHg
Diastolicbloodpressure
measurementrange20-210mmHg
Pulseratemeasurement
range40-200bpm
ResolutionBloodpressure:1mmHgor0.1Kpa;pulserate:1BPM
RepeatabilityThedifferenceofrepeatedreadingsofeachpointiswithin
4mmHginthestaticallycontinuouslow-pressuremode
AccuracyStaticAccuracy:±3mmHg;Pulserate:±3BPM
PressuretestingAmericanFreescalepressuresensor
WorkingpowersupplyBuilt-inLi-ionbattery
DatamemoryFlashmemorystoresupto300readings
CalibrationfrequencyAtleastonetimetwoyears
SecuritysystemTheratedrangeofcuffpressure:0~290mmHg
SamplingperiodMultipleindependentprogrammingcycle
SizeAbout119×52×21mm
NetweightAbout105g，includingbattery
WorkenvironmentT:5℃-40℃;HR:10%-95%;gaspressure:70KPa-106KPa
ConditionofstorageStoredundertheconditionoftemperature(-20℃-+55℃),HR
(nomorethan95%)andatmosphericpressure
(70KPa-106Kpa),nocorrosivegasesandwell-ventilated.
DatatransmittedbyUSBdatawire,Bluetoothconnection
Protectionagainst
harmfulingressofwater
orparticulatematter
IP22

19
SoftwareversionEmbeddedsoftware:1.0
PCsoftware:1.0
*Thereisnotfurthernoticeifproductspecificationchanges.
Chapter7EMCinformation
ThisproductneedsspecialprecautionsregardingEMCandneedstobeinstalledandput
intoserviceaccordingtotheEMCinformationprovided,andthisunitcanbeaffectedby
portableandmobileRFcommunicationsequipment.
Donotuseamobilephoneorotherdevicesthatemitelectromagneticfields,near
theunit.Thismayresultinincorrectoperationoftheunit.
Caution:Thisunithasbeenthoroughlytestedandinspectedtoassureproper
performanceandoperation!
Caution:thismachineshouldnotbeusedadjacenttoorstackedwithother
equipmentandthatifadjacentorstackeduseisnecessary,thismachineshouldbe
observedtoverifynormaloperationintheconfigurationinwhichitwillbeused.
Guidance and manufacture’s declaration –electromagneticemission
TheWBP-03Disintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerof
theuseroftheWBP-03Dshouldassurethatitisusedinsuchanenvironment.
EmissiontestComplianceElectromagneticenvironment–guidance
RFemissions
CISPR11Group1TheWBP-03DuseRFenergyonlyforits
internalfunction.Therefore,itsRFemissions
areverylowandarenotlikelytocauseany
interferenceinnearbyelectronicequipment.
RFemission
CISPR11ClassBTheWBP-03Dissuitableforuseinall
establishments,includingdomestic
establishmentsandthosedirectlyconnectedto
thepubliclow-voltagepowersupplynetwork
thatsuppliesbuildingsusedfordomestic
purposes.
Harmonicemissions
IEC61000-3-2Notapplicable
Voltagefluctuations/
flickeremissions
IEC61000-3-3Notapplicable

20
Guidance and manufacture’s declaration –electromagneticimmunity
TheWBP-03Disintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
theuserofWBP-03Dshouldassurethatitisusedinsuchanenvironment.
ImmunitytestIEC60601test
levelCompliance levelElectromagneticenvironment -guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floorsshouldbewood,
concreteorceramictile.Iffloor
arecoveredwithsynthetic
material,therelativehumidity
shouldbeatleast30%.
Electricalfast
transient/burst
IEC61000-4-4
±2kVforpower
supplylines
±1kVfor
input/output
lines
NotapplicableMainspowerqualityshouldbe
thatofatypicalcommercialor
hospitalenvironment.
Surge
IEC61000-4-5
±1kVline(s)to
line(s)
±2kVline(s)to
earth
NotapplicableMainspowerqualityshouldbe
thatofatypicalcommercialor
hospitalenvironment.
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputlines
IEC61000-4-11
<5%UT
(>95%dipinUT)
for0.5cycle
40%UT
(60%dipinUT)
for5cycles
70%UT
(30%dipinUT)
for25cycles
<5%UT
(>95%dipinUT)
for5sec
NotapplicableMainspowerqualityshouldbe
thatofatypicalcommercialor
hospitalenvironment.Iftheuser
oftheWBP-03Drequires
continuedoperationduring
powermainsinterruptions,itis
recommendedthattheWBP-03D
bepoweredfroman
uninterruptiblepowersupplyor
abattery.
Powerfrequency
(50Hz/60Hz)
magneticfieldIEC
61000-4-8
3A/m3A/mPowerfrequencymagnetic
fieldsshouldbeatlevels
characteristicofatypical
locationinatypicalcommercial
orhospitalenvironment.
NOTEU
T
isthea.c.mainsvoltagepriortoapplicationofthetestlevel.