BME 405 Final Report v03

WearableFallDetectorandMonitoringDevice

forSeniorPatientsFinalReport|December7,2015

UniversityofSouthernCaliforniaBME405:SeniorDesignProject

TEAM5

AkramKhanSulekhaRamayyaIsabellaTranMaksTsvetkov

WearableFallDetectorandMonitoringDeviceforSeniorCitizens

TableofContentsIntroduction....................................................................................................................................1

OverviewofHealthProblems&RisksintheElderlyPopulation...........................................................1ProductMarket&Stakeholders............................................................................................................2Competitors...........................................................................................................................................3ProductDesign&Safety........................................................................................................................4SimilarPatents&Devices......................................................................................................................5CommercialFeasibility..........................................................................................................................6

Objectives&Requirements............................................................................................................7DeviceDescriptionasOutlinedintheUseCaseReport........................................................................7ProjectUse-CaseSpecification..............................................................................................................7FunctionalRequirementsasOutlinedintheUseCaseReport............................................................11

DeviceDesign...............................................................................................................................13

TechnicalAnalysis.........................................................................................................................14ApplicationStructureandOrganizationfortheMainVIs...................................................................14UnderstandingtheSubVIs...................................................................................................................19

AccelerometerDataAcquisition...................................................................................................19InterfacingwithFileIO.........................................................................................................................25

UserInterface&FrontPanel........................................................................................................27

Validation.....................................................................................................................................32FallDetectionandAlert.......................................................................................................................32LocationDetermination......................................................................................................................35HeartRateMonitoring........................................................................................................................36

Constraints...................................................................................................................................37

OperationStandards....................................................................................................................37

NextSteps....................................................................................................................................38

RelevantCoursework...................................................................................................................39

Teamwork.....................................................................................................................................39MeetingMinutes.................................................................................................................................39

References....................................................................................................................................50


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IntroductionOverviewofHealthProblems&RisksintheElderlyPopulation

Therehasbeena significant increase in the life spanof the general populationover the lasthundredyearsdue toan increase in theavailabilityofmedicine, cleanwater, andanoverallexpansionofhealthpractices.Thelifeexpectancyhasrisenfrom50yearsforthosewhowereborninthe1900sto81yearsold indevelopedcountriestoday.1MillionsofBabyBoomers intheUnitedStatesarecomingofretirementage,anditisprojectedthatinthenexttwentyyearsthe population 75 years old and older will increase by 15 percent compared to the samepopulationinpreviousdecades.Forthisquicklygrowingelderlypopulationthemostcommonillnessiscoronaryheartdisease,followedbystroke,cancer,pneumoniaandflu.2

AccordingtotheNewEnglandJournalofMedicinetheelderlypopulationishighlysusceptibletomentalillnessessuchasdepressionanddementiaandtophysicalproblemssuchasarthritis,osteoporosis,andbreathingproblems.Additionallytheyexperiencelifestylechangesthatleadtoaslowerreactiontime,weakerimmunesystem,anddiminishedtasteandsmell.3

MedicalConsequencesofPatientFallsandaPotentialIdea

According to the CDC, one of themajor problems that the elderly face is not an illness butrathertheinjuriessustainedduetofalls.Theyreportthatoneinthreeadultsovertheageof65has significant falls; however, onlyhalf of these individuals talk to their healthcareprovidersabout them.For theelderlypopulation, fallsare the leadingcauseofboth fatalandnonfatalinjuries.Fracturesofthehip,spine,forearm,upperhand,wristareamongthemostcommoninjuriessustainedduringfalls,manyofwhichleavethepatientunabletomoveandoftentimesunconscious.Additionally, falls thatdonot leave thepatient injured still affect thementalityand confidence of the elderly; after a non-injury fall, patients tend to limit their physicalactivitiesforfearoffalling.4

A device that automatically alerts family and medical services of patient’s fall could greatlyincreaseresponsetimeandlimitorminimizethesustainedinjuries.ThedevicecoulduseGPStrackingtonotifyrespondersoflocationcoordinates,allowingforeasymonitoringandlocatingof at-riskor fallenpatients. It couldalso remotelyprovidebasic vitals. Thisbenefitof suchadevicewouldbetwo-fold: itwillallowformorerapidresponsetimes intreatingpatientsandwouldgiveseniorstheconfidenceandpeaceofmindtocontinuewithphysicalactivitywithoutfearofbeingaloneinthecaseofafall.Inaddition,suchadevicecouldbeusedinthelongrunto predict the likelihood of a falling incident through the usage of gait and stride patternrecognition, notifying the patient and giving them warning to grab on to support forstabilization.

TheGPSfeaturecouldnotonlybeusedtodetectapatient’s locationinthecaseofafallbutcanalsobeusedasatrackingdevicetomonitorthelocationofseniorsthroughouttheday.Amajorissuewithseniors,especiallythosesufferingfromdementia, istheproclivitytowanderoffwithoutasenseofdirection.TheGPStrackercouldeventuallynotifyfamilymembersifthe


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patient“stepsoutofsafebounds”.Thedeviceitselfcouldalsobeusedtoprovidefeedbacktothepatient if theyhavesteppedoutsideofadesignatedboundary.Approximately5.3millionpeopleintheUSlivewithdementiaandsixoutoftenwillwander.Thedangersassociatedwithwonderingcouldbeavoidedusingourproduct.

ProductMarket&Stakeholders

Patients

Patients are the final decisionmakers for a medical device and therefore it is important toanalyzethecurrentmarket.IntheUnitedStates,theelderlypopulationmakesuponeineverysevenadultsor14percentofthepopulationforatotalof44.7millionpeople. It ispredictedthatoverthenextfiftyyearsthatnumberwilldoubleandbemorethan20percentofthetotalpopulation. In 2013 there were 2.5 million nonfatal falls that were treated in emergencydepartments across the nation, relating to $34 billion worth of medical attention. Of thesecases,25,500adultsdiedbecausetheywerenotprovidedimmediateattention.4

Withintheseniorpopulation,1in3seniorsdieswithAlzheimer’soranotherdementia.In2015,Alzheimer’sandotherdementiaswill cost theU.S.$226billion.Memory loss isan incredibleissuewiththeseniorpopulation,as itcan leadtowanderingandthemgetting lostwithoutatrace.5Seniors,especiallythosewithdementia,makeupahugemarketandrepresentaterrificopportunityfordevelopmentofadditionalproducts.

Therequirementandattractivenessforsuchamedicaldeviceliesinthefactthatourdevicewillbe prioritize reducing the time it takes for immediatemedical attention and canbetter helpmonitorseniorpatients.Thisproductissuitableforallelderlypatients,makingthemarketforthe development of such a product extremely attractive, aswith time the device could alsodrasticallyreducethemassivecoststhatarecurrentlyincurredbyseniorpopulations.

Families

Thehealthandwellnessofseniorcitizensisofgreatimportancetofamilymemberswhooftengrapplewith the issue of giving the elderly complete autonomy versusmonitoring constant.Suchasdevicecouldinstillapeaceofmindinfamilymembers,whowishtoimprovethewellbeingoftheirolderrelativesbut liketoshyawayfromhelicoptermonitoring.Familiesareanimportant aspect of the market because they are the players that are likely to drive andconvinceseniorstoadoptandusesuchadevice.

FirstResponders

Anotherpushforsuchadevicecomesfromfirstresponderswhostrivetoprovideimmediateattention to ailing of injured patients. The GPS tracking system can facilitate the rapidnotificationofa fall tothefirstresponders,whileprovidingthemGPStracking. Inadditiontomusclefatigueandtripping,cardiacarrestcanalsocausecollapse.AccordingtoOccupationalHealth & Safety, cardiac arrest takesmore than 460,000 lives since the chance of survivingcardiacarrestdecreasesby7-10percentwitheveryminutethatpassesafterthecollapse.Thestudyalsofoundthatifthetimefromthecalltodefibrillationexceeded10minutestheresult


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couldbefatal.6Therefore,thereisarequirementfromfirstresponderstobeabletorespondtoseniorcitizens,recordvitals,andadministertheaidasfastaspossible.Theproductcanprovidenecessary information for vital information at moment’s notice from the fall and help firstresponderstoperformtheirdutymoreefficiently.

Physicians

Physicians are the primary individuals that recommend patient treatment. Therefore addingfeatures in a medical device that facilitate a physician's job is also important. Patientmonitoring fromhome is important fordoctors tobeableaccuratelydeterminethecauseofthefallandprescribemedicationorrecommendationsfromthere.Tocatertowardsphysicians,their input will be taken into consideration, as their promotion of such a product is key tosuccess.

InsuranceCompanies

Forthesuccessofamedicaldevice,insurancecompanieshavetobeonboardtofootthecostofsomeifnotmostofthebill.Sincethisproductisintendedforsenioraudiences,gettingMedicaidtosupportthe“prescription”ofsuchadevicewillbecrucialforproceedingwiththemarketinganddevelopmentoftheproduct.Thiswillbediscussedinmoredetailbelow.TheopportunitytoreducethemassivecostsincurredbyseniorcitizensintheAmericanHealthcareSystemisanimportantfactorthatshouldencouragethesupportofMedicaid.

Competitors

Thereremainafewcompetitorsinthisspace:COMPANIES PRODUCTOFFERING

! PhilipsLifeline’sproductlinehasaproductcalledGoSafewhichbundleshardwarewithaservice

! Thesystemoffers24/7emergencyassistanceandusesAutoAlerttodetectfalls

! ThedevicehangsaroundtheneckandprovidesGPStrackinginformationbutisunabletocollectvitals

! Thisisourdevice’sbiggestcompetitor

! ThisproductisverysimilartoPhilipsproduceinthatitisapendentaroundtheneck

! Theyhavejustintroducedautomaticfalldetectionbutrelyonthepatienttopushabuttonforassistance

! Thisproductdoesnothavefalldetectionbutenablesthepatienttohaveatwo-wayconversationwithaMedicalAlertAgent


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COMPANIES PRODUCTOFFERING

! Thisisaleadingauto-falldetectionproduct;howeverthepatientmustholdthedeviceatalltimesforfall-detectionasnonecklaceorwatchmechanismispresent

! Thisproduct,likemanyoftheothers,isapendentthatrunsoncellularservicebutlacksmobilitytoworkoutsidethehouse

Thecompetitorsmentionedabovealloffersimilarproductsandservicesthatrangeanywherefrom$20–80/monthwiththecompanyowningthedeviceandchargingfortheservice.Allofthedevicesappearsimilarandmostarewornasapendent.TheyallhaveGPStrackingandautomaticcallingservices.Noneofthedevicescantakebasicvitalsorcanbeusedoutsideofahome,whichsetsupaninterestingpropositionforwhenwewanttothinkaboutproductdevelopment.

ProductDesign&Safety

MeasurementInstruments

! Heartmonitor:torecordapatient’sheartrate! GPSsensor:tolocateapatient’sgeographiccoordinates! 3-axisaccelerometerandgyroscope:todetectandtrackfalling-motion! myRIO:interfaceusedformonitoringandinterfacingwiththedevice

UserInterface

! Fortheuserandfamilymembers:− DisplayofpatientlocationonGoogleMaps− Abilitytosetboundariesfor“safezone”− Visualizationofvitalsdataovertime

! Forprofessionals(physiciansorparamedics):− GPSvisualizationofpatientlocation− Visualizationofpatientstatisticsincludingbasicpersonalinformation

SafetyConcerns

Ashas been the casewith cellphones, there remains questionwhether the continuouswearandusageofwearabledevicesissafe.Thereisconcernthat,especiallyoverthelongrun,theusageof suchdevices can lead to tumor growth, disturbedblood rhythms, andother healthproblems.Asidefromthis“radiation”factor,mostofthesecomponentsareharmlessandhavebeenusedforawhileforthepurposeofpatient-healthmonitoring.7


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SimilarPatents&Devices

PatentNumber:2,009,048,540 Title:WearableHealthMonitoringDeviceandMethodsforFallDetection Thispatentlicensestherighttoawearabledevice,inwhichthedeviceusesatleastonesensorinordertodetectthefallofthepatient.Thepatentencompasses:

! Incorporationofanaccelerometer ! Capabilitytodeterminetheorientationoftheusers ! Capabilitytodetectthechangeinorientationoftheuser ! Capabilitytodetermineiftheuserhasfallenusingtwoconditions:

− Exceedingacertainspeedontheaccelerometer − If there is a change in the user’s orientation from a vertical position to a

horizontalposition ! Capabilityoftransmittingtheinformationthattheuserhasfallentoanexternaldata ! Anywearabledevice that isused tomonitorphysicalhealth, activity,human state,

andfall Ifweareplanningtocommercializethedevice,wemust licensethispatent firstbecauseourdevice will incorporate all of the patent’s features; we plan to use the same conditions todetermineifthepatienthasfallen.Wearegoingtoincorporatetheaccelerometertomeasurethespeedatwhichtheuser is fallingand if there isasuddenvertical tohorizontalchange inorientation.Wewilladdathirdconditionwhereiftheuserisnotresponsiveforapproximately30seconds,thedevicewill thentransmitasignaltothenearestemergencycare.ThiswillbepinpointbyaGPSdevice.Sincethosedonotfallunderthispatent,wedonotneedtolicensethoseideas.Wewillalsoincludeavitalsmonitoronthisdevice,whichwouldhelpdifferentiateourproductfromthispatent.8

PatentNumber:1,641,388(EuropeanPatent) Title:DevicesandMethodsforHeart-RateMeasurementandWristwatchIncorporatingSame Thispatentlicensestherighttoaportabledeviceandthemethodsofmeasuringtheheartrateby:

! MethodofreceivingECGsignals ! MethodofselectingtheQRScomplexfromthesignals ! MethodofevaluatinginstantaneousheartrateusingmultipleQRScomplexes ! Awrist-watchthatincorporatesaheartratemonitor

Ourdeviceplansto incorporatetheheartmonitoronawristwatch-likedevicethat isusedtodetect falls.Tobeabletodothis,wemust licensethemethodofdeterminingtheheartrateand idea from this patent. The device should be able tomeasure the user’s heart rate andconvertthesignalsintoanumberfortheuser.9

SimilarProduct:Lifeline Asmentionedabove,thisproductandservice issimilartotheproduct/servicebundlewearedeveloping.Ithasasensorthatdetectseverydayactivity,whenwornaroundtheneck.Whenitdetectsadrasticchangeinheight, itwillgivetheuser30secondstogetbackuporpushthe


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helpbuttonbeforeitautomaticallyphonesaLifelineemployee.Theemployeewillthencallandaskiftheuserisokay.Ifthereisnoresponse,theemployeewilldialemergencyfortheuser.

Our productwill incorporate the same idea; however,we plan to incorporate a vitals signalmonitorthatwillbeeasilyaccessiblebythephysician,patient,andparamedics.Wealsoplantouse the vitalmonitor to detect anydrops in vital signs andnotify the caretaker or physicianimmediately.Insteadofanecklace,weplantomakeitawearablebraceletsothepatientdoesnotfeelhindered.Thiswillbebodyheat-activatedtoavoidfalsealarms.10

CommercialFeasibility

CostofProductionandSalePrice

Ourcurrentprototypeisquiterudimentarywithlimitedcapabilities.However,itdoesprovideatremendous platform to allow for further development. Because we would like to furtherenhancethedevicewithadditionalsensors,weareunsureofhowmuchsuchadevicewouldcost,ascostdependsonrawmaterial,labor,andscale.WedoknowthatifaFitBitcansellfor~$150andmaintainprofitability,ourdevicecanalsobepricedinasimilarpricerange,asthedevices have similar components. Initial costs towards the development of the web user-interfacewillalsoneedtobeaccountedfor.

It is important to note that an important selling feature of this device is the service, whichwouldbeanaddedexpense.Thecostoftheproductcouldbeminimizedforthecustomerbyembeddingthepriceofthedevicewithinthemonthlysubscriptionfee.Spreadingthecostofthe device over a 12-month basis would put the base fee for the bundled package at$25/month,whichcanthanbeincreasedtosubscriptionfeesashighas$80/month,matchingwiththehighendsubscriptionfeesoftoday’smedicalalertsystems.Thereismorethanenoughroomformarginonthisproduct,makingitattractivefromabusinessperspective.

MarketDemandandCommercialFeasibility

Thereissignificantdemandtoservetheseniorcommunity’shealthneeds,especiallyasthesizeof the population continues to grow. There is also a need to reduce costs associated withailmentsandinjuriesthatcanbeprevented.Therefore,developingadeviceinthefall-detectionspace is a worthwhile investment, considering that the market is quite large and fairlyfragmentedallowingforanewplayerwithaninnovativeproducttogainmarketshare.

Because our intended device has more features than the standard that is currently on themarket,itwilllikelybeonthehigherendofmarketpricerange.However,inordertomaketheproduct more affordable and commercially feasible, we will approachMedicare in order tohave the device classified as Durable Medical Equipment (DME) 11 ; this way, insurancecompaniescanpayforpartoralloftheservice.FromtheeyesofMedicare,thisproductwouldbe beneficial in reducing costs from easily preventable injuries. It can also be a vital part incaringforthosewithdementia,makingtheproductnecessaryforthewell-beingofthosewithaspecificdisease.Currently,MedicarePartBdoesnotcovermedicalalertsystemssuchasourproduct;however,MedicareAdvantagedoescovertheseproducts.12


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Objectives&Requirements

DeviceDescriptionasOutlinedintheUseCaseReport

Thepatientwearsthedeviceonacontinualbasis,andthedevicecollectsthepatient’svitalsinformation(i.e.heartrate,temperature,etc.)andgeographiclocation.Thedevicemustinitiallyset-upandcalibratedwiththepatient’spersonalhealthinformation,afterwhichpointthedevicewillbecomepartofhisorhersdailyroutine.Oncewornbythepatient,thedeviceisactive.Thedeviceisindicatedtodetectfalls,andforthisreason,thisisthebasecaseoftheproduct.Ifduringthenormalsamplingofpatientdatathedevicedetectsasharpdroporchangeinaccelerometercoordinates,thedevicewillpromptthebasecase.Duringthebasecase,adetectionofafallwilltriggersignalinginwhichvitalsdataandgeographicarecommunicatedtofirstrespondersviaacloud-basedportal.Alternativeflowsincludingtheuserbeingabletocontactfirst-responderson-demandandfamilymembersbeingabletocheckonthestatusoftheirloved-ones.Exceptionsexistforimproperlyconnectedsensors.

Wetriedtoaccomplishasmanythingsaswecouldinourdeviceprototypeasoutlinedintheusecase.However,evenwhenwritingthedesignreport,werealizedthatwewouldhavetodecreasethenumberofobjectivesforthedeviceinordertofeasiblybuildsomethingwithinthegiventimeframe.Wedecidedtolimitthesensorstoaccelerometer,GPS,andheartrate,withanaddedbuttontoturnthedeviceonandoff.Thesesensorswerevalidatedwiththetestsmentionedbelow.

ProjectUse-CaseSpecification

Thefollowingoutlinesanabbreviatedprojectuse-casespecification.Ithasbeenupdatedfromwhatwasinitiallysubmittedtoreflectthetruecapabilitiesofthedevicewedeveloped.

ProjectName: WearableFallDetectorandMonitoringDeviceforSeniorPatients

UseCaseName: PatientMonitoringandMotionDetection

UniqueIdentifier: Monitoring

1. Actors

Actor1:Patient

Actor2:CloudStorage(Dropbox)

Actor3:OnlineTrackingPortal


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Actor4:FamilyMember

Actor5:FirstResponder

2. Assumptions

1. Devicehasconnectivity2. Sensorsareproperlyfunctioning3. Onlineportalandcloudstorageareproperlycommunicating

3. Pre-Conditions

1. Allofthedevicesensorshavebeencalibrated2. Patienthasameasurableheartbeat3. Firstrespondershaveadispatchsysteminplacethatcanallforaninfluxofdatafrom

peoplerequiringassistance

4. BasicFlow

FlowIdentifier: PatientWearsDeviceDaytoDayandaFallisDetected(“Happy”DayScenario)

Step UserAction

1 DeviceCalibration:Theusecasestartswhentheuserbuysthedevice,unboxesthedevice,andwearsthedevice.Thedevicemustconcurrentlybecalibratedusingacalibrationscreen.Thedevicewillprompttheusertoenterbasicinformation(i.e.name,age,etc.).

2 DeviceActivation:Thedeviceisonlyactivatedwhentheuserinteractswiththeinterfacesystemtoturnthedeviceon;thisistopreventfaulty,randomdatacollection.

3 DeviceCheck’sUser’sHeartRate:Duringtheday,thedevicecontinuouslymonitorsandcollectsheartrateinformation.ThishappenscontinuouslyandcanhappenatanypointafterBF1.Thisalso


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happensintandemwithBF3andBF4.

4 DeviceCheck’sUser’sLocation:Duringtheday,thedevicecontinuouslymonitorsandcollectsGPSlocationinformation.ThishappenscontinuouslyandcanhappenatanypointafterBF1.

5 FallDetectionandDistressSignal:Thedevicewillcontinuallymonitorthepositionoftheuserandusethedevice’saccelerometertodetectafall.Thedevicewillascertainthatthefallwasnotmisinterpretedbypromptingtheuser.Ifthiswasafalsealarm,thefalldetectorwillbereset.Otherwise,thedevicewillcontactandalertfirst-responderswithinashorttimespan.

6 PatienthasFallen&FirstRespondersareNotifiedwithInformation:ThepatienthasfallenandthefirstrespondersarenotifiedwithdatafromBF7tocontactthepatient,atwhichpointthepatientwillreceiveacallandfurtheractioncanbetaken.

7 DeviceRemoval&SystemTurn-Off:Thefirstresponderwillthenremovethedevicefromthepatientandturnthedeviceoff.Theusecaseendshere.

5. AlternativeFlows

FlowIdentifier: UserisNotaFirst-TimeUser

Step UserAction

1 SkipBF1andproceedwiththerestoftheBasicFlowstartingwithBF2.

FlowIdentifier: PatientVoluntarilyCallsforHelp

Step UserAction

1 AtanytimeduringBF2-BF6,theusercaninterfacewiththesystemtomanuallysignaltoafirstresponderforhelp.Thedevicewillprompttheusertoconfirmthevalidityofthecallforhelp.

2 TheuserconfirmsthedecisionandtheusecaseresumestoBF7.


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6. ExceptionFlows

FlowIdentifier: FaultyDataCollection

Step UserAction

1 AtBF1oranypointduringtheBF,thesystemdetectsthatitcan’tmeasurevitalsigns.

2 Ifvitalsignsdonotturnonthedevice,theusermayhavetheoptiontoturnonthedevicemanuallyandtroubleshoot.

3 Untiltheuserfixesthedevice,noinformationwillbesenttothecloudandnomeasurementscanbetaken.

7. PostCondition

Thisusecasecanendwithanyofthefollowingpost-conditions:

1. Userremovesdevice2. Deviceshutsoffbecauseoffaultyconnectivityorfaultysensors

8. Artifacts

1. Rawdataoftheuser’sheartrate2. GPSLocationoftheuser3. Distresssignaltothefamilymember,caretaker,orfirstresponder4. Displayportalofdatacollected

9. ProjectUse-CaseSpecificationForm/Signatures

ProjectName: WearableFallDetectorandMonitoringDeviceforSeniorPatients

ProjectManager: Jean-MichelMaarek


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IhavereviewedtheinformationcontainedinthisProjectUse-CaseSpecificationFormandagree:

Name Title Signature Date(MM/DD/YYYY)

AkramKhan Student AK 12/05/2015

SulekhaRamayya Student SR 12/05/2015

IsabellaTran Student IT 12/05/2015

MaksTsvetkov Student MT 12/05/2015

FunctionalRequirementsasOutlinedintheUseCaseReport

Thefollowingtabledescribestheconstraintswehadinplacewhendesigningourdevice.Eventhoughweinitiallyoutlinedtheseasconstraints,wedidnotnecessarilyabidebythemwhengoingthroughthedevelopmentprocess.Forone,thedevice,althoughinitiallyintendedtobewearable,remainsbulkybecauseofresourceconstraintspresentedbylimitationsofthehardwareavailableinthelab.BecauseweareusingthemyRIOdevice,wedonothaveawirelessdevicebecausethedeviceitselfconsumesconsiderablepowerandmustbepluggedin.Inaddition,wirelesslycollectingdatawasnotpossiblegiventhetime-framefordevelopment.Lastly,forthisdevicetobetrulyuseful,wewouldneedtowaterproofeverythingsothatthepatientcanuseitintheshower.

Constraints

1. RequiresLabVIEWandproductdrivers2. Mustbewearableand/orportable3. Musthaveaspecificsamplingrateandsensitivitytoprovideaccuratedata4. Powersourcemustlastasignificantlengthoftime5. Mustcommunicatewirelessly6. Waterproofandshockproof

Thefollowingtablere-visitsthefunctionalrequirementsasoutlinedintheoriginalUseCaseReportanddescribeswhetherornotthefunctionalrequirementsweremetwithourgivendesign.

FunctionalRequirementsfromUseCaseP=Processing,I=Interface,D=Data


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Step Req.Type FunctionalRequirement FRMet?

BF1 I Thesystemshallhaveamaininterfaceforinitialization Y

BF1 I,D Thedeviceshallhaveameanstoenterdata Y

BF2 I,PThedeviceshallhaveawayofidentifyingwhetherthedeviceisactuallyontheuserandshallonlybeactivatedonceontheuser

Y

BF3,6,8 D Thedeviceshallhaveawaytodetectheartrate Y

BF4,6,8 D Thedeviceshallhaveawaytodetecttemperature N

BF5,6,8 D ThedeviceshallhaveawaytodetectGPSlocation Y

BF3,4,5,6,8 D Thedeviceshallhaveameanstocollectdataandpushittoacloudsystemforstoring N

BF7 D Thedeviceshallhaveawaytodetectsfalls Y

BF9 P,D Thedeviceshallbeabletosendadistresssignalandnotifyfirstrespondersupondetectionofafall Y

AF I Thedeviceshouldhaveameansbywhichtheusercancallforhelpon-demand Y

AF P,IThesystemshallhaveameanstotaketherawdataandconvertitintoaformthatcanbeaccessedthroughaportal

Y

AF D Thedatastoredincloudstorageshallbeabletointeractwithauser-friendlyportal N

AF D Thecloudstorageshouldbeabletocleardataaftersometimeautomatically N

EF I Thedeviceshouldbeabletorecognizelackofconnectivityandpromptfortroubleshooting N

EF D Thedeviceshallhaveawaytotemporarilystoredata N


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Mostofthefunctionalrequirementsthatwereoriginallyoutlinedaremetbythedevice;however,somefeatureswereeliminatedforlackofimportanceorrelevanceinthefunctionalityofthedevice.Forone,temperaturewaseliminatedbecausewefeltasthoughitdidnotaddmuchvaluetothedeviceitself.Moreover,theavailabletemperaturesensingdevicesaretoobulkytofittheparametersofapseudo-wearabledevice.Anyfunctionalrequirementsdealingwithdatastorageoracloudwereeliminated,aswebelievethatthisdataisonlyrelevantinrealtimeandwouldhavelittlevalueifstoredinacloud.Athirdpartyaccessportalwaseliminatedbecauseitgoesbeyondthescopeofthiscoursetodevelopawebinterfacethatcanbeaccessedbyanyone.Atthispoint,thedeviceisreallydesignedonlyfortheuserwearingthedevice,asinterfacingforthirdpartieswasnotdeemedimmediatelyrelevant.

DeviceDesignThedeviceitselfhasasimplisticdesigninthatweleveragethecapabilitiesofthemyRIOdevicebyaddingtwoothersensorstothemyRIOcontrollerviaanexpansionprotoboard.Themainsensorbeingused,theaccelerometer,isbuiltintothemyRIOdevice.Inaddition,weusedasimplistic,analogheartrate,pulsesensorfromSparkFun(https://www.sparkfun.com/products/11574),whichwasconnectedasfollows:

WealsousedadigitalGPSsensor,andconnecteditasinstructedinitsDataSheet.WeusedthePmodGPS–GPSreceiver(https://www.digilentinc.com/Products/Detail.cfm?NavPath=2,401,1038&Prod=PMOD-GPS)madebyDigilent.


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Thefinaldevicelooksasshownbelow.Forthepurposesoftesting,themyRIOdevicewasheldandtheheartratesensorwaswornonthefinger.

TechnicalAnalysis

ApplicationStructureandOrganizationfortheMainVIs

GeneralSystemOverview

Whenrunningtheuserisrunningthedevice,theyneedtorun2MainVIs.BecauseweareusingthemyRIOdevice,allofthesystem’sdatacollectionVIsarerunonthemyRIO.Ontheotherhand,alloftheprocessesthatdealwithanalyzingandinterpretingtherawdatasignalscollectedfromthemyRIOdevicearehandledonMyComputer.Thisisbecausemanyofthebuilt-inLabVIEWfunctionsweuseindataprocessingarenotmyRIOcompliant.Insummary,theuserwilllaunch2MainVIswhenoperatingthedevice:MyComputerMain–FallDetectorAlgorithm.viandMyRIOMain–DataAcquisition.vi.Asnapshotofourprojectwindowcanbeseenhere:


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MyRIOMainVI

LookingatMyRIOMain–DataAcquisition.vi,itisanextremelysimpleVI.Ontheblockdiagramallweseearethreeicons,representingthethreeiconsofthethreesubVIsthatareresponsiblefordatacollectionfromtheaccelerometer,GPSsensor,andheartratepulsedetector:AccelerometerDataCollection.vi,GPSDataAcquisition.vi,andHeartRateDataAcquisition.vi.SimplyrunningMyRIOMain–DataAcquisition.viwillautomaticallystartrunningallthreeofthesubVIsonthemyRIOdevice.

MyComputerMainVI

WhenworkingonthearchitectureforthemainVIonMyComputer,werealizedthatastatemachineorparallelloopstructurewouldreallynotsuittheobjectiveofourprogram.Becauseourdevicefocusesoncontinuousmonitoring,themostobviousstructureisawhileloopwithcasestructureformat.WewilladmitthatthisMainVIisquiteintimidatingandhardtonavigate.WedidtrytousesubVIsandglobalvariableswhereverpossible.However,intheendwedid


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nothaveenoughtimetocompresseverythingintoaone-paneldisplayonLabVIEW.WewillattempttobreakdownanddiscussthepiecesoftheVIinthefollowingcommentary.

Almosteverythingthatisimportantlieswithinthetruecaseofthecasestructure.Inabroadersense,thecasestructureiswithinalargewhileloop.ThiscasestructureiscontrolledbyaBooleanthatistitledOn/Off.ThisBooleaniscontrolledbytheusertoturnthedeviceanditsmonitoringcapabilitiesonandoff.

Withinthetruecase,thereare4mainoperations:falldetectionanalysis,GPSlocationacquisition,heartratedetection,andfalldetectionemailalert.Wewillgointodetailoneachoftheseoperationsbelow.

FallDetectionAnalysis&Algorithm

AglobalvariableclustercalledMyCompAccelerometercontainstheaccelerometerdatafromthemyRIOdevice.Thedataisunbundledpointbypointandaddedtoanarraythatcontains500ofthelatestaccelerometerpointsineachofthex,y,andzdirections.Thesearraysarethenfedintoacasestructurethatkeepsthedataasisinthe“false”caseandresetsthearraystoarraysof500zerosinthe“true”case.Allofthearraysareclusteredandsenttoashiftregisterthatupdateswitheveryiterationofthewhileloop.Thiscasestructureiscontrolledbywhetherornotafallhasbeendetected.Ifafallisdetect,thecasestructurewillbetrueandthedeviceessentiallyresets.Thisdataisthensenttobeprocessedintwoways:inthefrequency/waveletdomainandinthetimedomain.Theportionofthecodebelowshowsthedatabeingsentthroughthediscretewavelettransform.


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Theresultsofthewavelettransforminthex,y,andzdirectionsarethencollectedandtheresultantiscomputed.Similarlyaresultantiscomputedfortheraw,pre-wavelettransformationdata.Theresultsoftheseresultantcalculationsarecomparedtobenchmarksthatweredeterminedthroughtrialanderror.Inthetimedomain,aresultant>2.5wasindicativeofafall.Inthewaveletdomain,aresultant>2.5wasindicativeofaweakfallandaresultant>4wasindicativeofastrongfall.Theresultsofthesecomparisonswerethenconvertedtodynamicdata,andonlyinthecasethatafallwasdetectedinboththetimeandwaveletdomainsdidthefalldetected?Booleanregisteranddidthesystemrecognizeafallhavingtakenplace.WeusedCollectorsbecausetheyutilizethemostrecentdatacollectedandmakethisatrulyrealtimedevice.Thesnapshotoftheblockdiagrambelowillustratestheanalysisportionandalgorithmofthefalldetector.Inreality,thiscouldhavebeenasubVI;however,whenwemadethefallanalysisportionasubVIwekeptgettingerrors.Withoutsufficienttimetodebug,wedecidedtoleavethisportionoftheprogramuncompressed.

GPSLocationAcquisitionandDisplay

WewantedamapofwiththeGPSlocationoftheusertodisplayonthefrontpanel.Inordertodosoatarateslowerthantheconstantrateofacquisitionfortheaccelerometerdata,weplacedanothercasestructurethatiscontrolledbyacounter.Whenthecounterhitsamultipleof1000,thecasestructureistrueandthesystemwillreferencetheglobalvariablesoflatitudeandlongitudetoformaURLthatwilltakeustoanimageofaGooglemap.Thisbuildsinasmall15seconddelayintothemaprefresh,whichisimportantbecauseGooglehasalimitonthenumberofmapimagesthatcanbesourcedonadailybasis.


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HeartRateDetectionandDisplay

ThisportionisfairlystraightforwardbecauseittakestheglobalheartratevariableofMyRIOBPManddisplaysitonthefrontpanel.

EmailAlertandHelpNotifications


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Inthecasethatapatienthasfallen,anexpressVIcalledAskUserwillprompttheusertoseewhetherornottheywouldliketosendanalerttotheiremergencycontact(seeblockdiagrambelow).AsimilarcasestructurecontrolledbyaBooleanHelpButtonisalsopresentontheblockdiagraminwhichthepatientcanaskforhelpon-demand.

OutsideoftheWhileLoop

Verylittleliesoutsideofthelargewhileloop,exceptforacasestructurethatpromptstheuserforpersonalinformation;thisisdiscussedunderInterfacingwithFileIO.

UnderstandingtheSubVIs

AccelerometerDataAcquisition

ThisblockdiagramisanopensourcecodetoreadthedatafromtheMyRIOAccelerometer.Theprogramhasthreestates:Initial,Idle,andAcquire.Theacquirestateiswherethedatacollectionhappens.Intheacquirestate,theVIreadstheX,Y,andZaxesofbuilt-inaccelerometerandoutputsthedataasanarray.Thedataisthenbundledandisoutputtedintoagraph.Thegraphisshownonthefrontpanelanddisplaysthemovementatall3axes.Thedataisthenwrittenintoasharedvariable(labeledMyCompAccelerometer),whichwillthenbeusedtotransferthedatatotheMainVIwhereitwillbeanalyzed.


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GPSLocationAcquisition

ThiswasanopensourcecodethatbasicallyacquiredtheGPSsignalfromtheMyRIOusingVISAanddisplayedthedatashowninthefrontpanelbelow.WhatweneededfromthisVIwastheLatitude,Longitudeandthedirection.ThisinformationwastakenandinputtedintotheSubVIshownbelow.TheLongitudeandLatitudeSubViwilloutputapositiveornegativevaluedependingonthedirectionofthecoordinates.Thevaluesarethenwrittenintoasharedvariable(labeledLatitudeandLongitude),whichwillthenbeusedtotransferthecoordinatesintotheMainVIwhereitwillbeanalyzedondisplayedonGoogleMaps.


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Longitude/LatitudeConversionSubVI

Thissubvibasicallytakesthelatitudeandlongitudevaluesanddeterminewhethertheyarepositiveornegativedependingontheirdirection.ForLatitude,NorthisconsideredpositiveandSouthisnegative.ForLongitude,EastisconsideredpositiveandWestisconsiderednegative.Thedirectionisinputtedintoaselectfunctionandbasedonthedirection,theoutputwillbethepositiveorthenegativevalueofthelongitude/latitude.

PulseRateDataAcquisitionandAnalysis

ThisSubVicollects1pointevery0.01seconds(100points/second)ofthepulseratefromMyRIO.Thedataisthenconvertedintoanarrayandmadeintoawaveform.Therawpulsedataisdisplayedinthegraphshowninthefrontpanel.Theloopwilldisplayatotalof1000pointsresultingin10secondsofdata.Eachpeakistheoreticallyapulse.ThatdataistheninputtedintoapeakdetectionfunctioninLABVIEWandmultipliedby60togetthenumberofbeatsperminute.ThedataisthenwrittenintoasharedvariablewheretheBPMwillbedisplayedonthefrontpaneloftheMainVI.


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GoogleMapsDisplay

TheGPScoordinates,zoom,maptype,andsizeofthedesiredmapareusedtoconcatenateaURL,whichisusedtodisplayanimageofthelocationofthepatient.TheconcatenatedstringisinputtedintoaWebbrowsernode,whichwilldisplaytheInternetimageontheFrontPanel.Theentirecodeissurroundedbyacasestructuretolimitthenumberofimagesthatwillbedisplayed.


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AskUserSubVI

ThissubVIwasanopensourcecodethatbasicallypopsupascreenthatwillallowtheusertomakeaselectionwithin10seconds.Iftheuserhasfallen,awindowwillpopupaskingiftheuserwouldliketosendanalert.IftheuserselectsyesthesubVIwilloutputTrue.Iftheuserdoesnotrespondwithin10seconds,thesubVIwillalsooutputTrue.Iftheuserselectsno,the


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subVIwillcloseandwillremainfalse.TheoutputofthisVIwilldeterminewhetherornotanemailissentouttothepatient’semergencycontact.

InterfacingwithFileIO

FileCreationintheMyComputerMainVI

Wearenotreadingorwritingmassiveamountsofinformation.However,whenMyComputerMain–FallDetectorAlgorithm.viislauncheditcheckswhetherornotafilecontainingpatientinfohasbeencreatedbylookinginapre-specifiedlocation(E:\BME405\Project\myRIOFallDetector\FallDetectorProject\PatientInformation\patientinfo.txt).TheresultofthisBooleanfeedsintoacasestructurethatonlypromptstheusertoentertheirinformationifafilecan’tbefound:


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FileCreationSubVIs

WeuseanexpressVIcalledPersonalInformation2tocollectthepatientinformationviaapop-upandwritetheinformationtoafileviathesubVIPersonalInfoWrite.vi(P.I.Winicon).ThatsubVIlooksasindicatedbelow:

InthissubVI,wetakeallofthecollectedpatientinformationandconvertitintoacarriagereturndelimitedstringarray.WeusethefunctionArraytoSpreadsheetStringtowritethedatatoatextfileasastring.Weusethestandardopen/read/closefilesequencewithanerrorhandler.Similarly,wehaveanothersubVIcalledPersonalInfoRead.vithatreadsfromtheSpreadsheetStringandconvertsitintoanarraywiththepatientinformation.ThissubVIisused


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intheportionoftheMainMyComputerVIthatdealswithsendinganalertmessage.Itworkstopersonalizethealertmessagebeingsent.ThearchitectureofPersonalInfoRead.viisessentiallytheoppositeofthatofPersonalInfoWrite.vi.

UserInterface&FrontPanelAsidefromwearingthedevice,theuserwillhavetointeractwiththecomputer.Giventhatourproductistargetedtowardsseniors,wewantedtomaketheuserinterfaceasintuitiveandsimpleaspossible.Whentheuserrunsthedevicefortheveryfirsttime,theyarepromptedtoinputtheirpersonalinformationwiththepop-upbelow.Thisinformationisstoredinafileandismaintainedandreferenceduponeachsubsequentuseofthedevice.


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Oncethepatienthasenteredtheirpersonalinformation,theyaregreetedbytheeversosimplisticfrontpanel,whichtheywillinteractwithonaminimalbasis.Inordertoinitiatethedevice’smonitoringcapabilities,thepatientmustturnonthedevicewiththeOn/Offswitchfoundonthefrontpanel.Itshouldbenotedthatthereareonly3buttonsonthefrontpanel:On/Offswitch,Helpbutton,andStopButton.Therearealsoelementsthatdisplaytheuser’sGPSlocationonamap,theirheartrateinbeatsperminute,andanindicator,whichsignifieswhetherornotafallhasbeendetected.Thesettingsofthemapcanbechangedaccordingtovisualizationpreferences.Oncethedeviceisturnedontheuserseesthefollowing:

Inthecasethatafallisdetected,theuserwillbrieflyseethis:


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Oncethefallisdetected,thefrontpanelwillchangetoaprompt,whichwillasktheuserwhetherornottheywanttosendanalert.Iftheprompttimesout,thesystemwillsendanemailalertbydefault.


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Theusercanalsocallforhelpon-demand,inwhichcaseasimilarpop-upwilldisplay:


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Inthecasethattheuserdoeswantanemailalerttobesent,anemail(asseenbelow)willbesendtotheemergencycontactdesignatedintheoriginaldeviceset-up.Thisemailwillhavegeneraldetailsabouttheuserandtheirfall,includingalinktoamapwiththeuser’slocation.


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Validation

FallDetectionandAlert

Sensor:Tri-AxisAccelerometer

Purpose:Touseaccelerometerdatatodeterminewhetherornotthepatienthasincurredafall,andthensendanalerttoafamilymemberifafallwasinfactincurredbypromptingtheuser.

Test:Wewillputthedeviceonatestsubjectandhavehimorherwalkaroundwhilewearingthedevice.Wewillmakesurethatthefallsensorisnottriggeredbyregularwalkingmotionsoractivity—ifthedeviceisfalselytriggered,wewillhavetoadjustthethresholdvaluesforwaveformandtimedomainanalysisoftheaccelerometerdatatomakeitlesssensitivetonormalmotion.Beyondthis,wewillmakethetestsubjectfallatvariousintensitiestodeterminewhetherornotthesystemcorrectlydetectsthefallandappropriatelysendsanemailalertwiththecorrectfallintensitylevel.

Results:Whenthedevicewaswornwhilethewearerwaswalking,thealgorithmaccuratelydidnotdetectafallineitherthetimedomainorwaveletdomain.


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Whenthedevicewasshakenviolentlyasthoughthewearerwasrunning,thealgorithmaccuratelydidnotdetectafallineitherthetimedomainorwaveletdomain.


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Whenthedevicewasdroppedtosimulateafall,thealgorithmdidaccuratelydetectafallinboththetimedomainandthewaveletdomain.Oncethefallwasdetected,theuserwaspromptedtosendanalerttoathirdparty.


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LocationDetermination

Sensor:GPSSensor

Purpose:Todeterminethelocationofthesubjectwearingthefalldetectordevice.

Test:WewillchecktomakesurethatthelocationseenonthemapontheLabVIEWinterfacematchestheactuallocationofthesubject,andthatthislocationisthesameasthatsentinthelinktothealertedparties.Thisprocedurewillberepeatedintwodifferentlocationstoensurethatthelocationrefreshesappropriately.

Results:WetestedthemyRIOdeviceandtheGPSSensorintwolocations:thelabinDRBandSulekha’shouse(overThanksgiving).Themaponthefrontpanelrefreshedaccordinglyandthefollowingmapswereattained.Therefore,wewereabletovalidatethattheGPSsensorwascorrectlyworking.


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HeartRateMonitoring

Sensor:HeartRateSensor

Purpose:Todeterminetheheartrateofthesubject.


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Test:WewillcomparetheHRmeasuredbytheLabVIEWintegrateHRsensorwiththeHRdetectedbytheautomaticbloodpressuremonitortoseeiftheymatch.Thisprocesswillberepeatedfor2subjectstoascertaincertaintyofaccuracytorepetition.

Results:Wetestedtheheartratemonitorontwosubjects:IsabellaandYuhao.ForIsabella,thedevice’sheartratemonitormeasuredarateof78bpmandtheautomaticbloodpressuremachinemeasuredaheartrateof79bpm.Thisisadifferenceof1.2%,whichisfairlynegligible.ForYuhao,thedevice’sheartratemonitormeasuredarateof118bpmandtheautomaticbloodpressuremachinemeasuredaheartof119bpm.Thisisadifferenceof0.8%,whichisfairlynegligible.Forthisreason,wecanconcludethattheheartratemonitorisfairlyaccurate.

ConstraintsKnowledge

Ourbiggestconstraintduringthisprojectwasundoubtedlyourknowledgegap.Althoughsmallbitsandpiecesofpreviouscoursesdidsurfaceduringourdesignprocess,wefeltinadequatelypreparedtojumpintothisprojectrightaway.Assuch,wehadtodotremendousresearchandlearningontopicssuchasArduinoanddatacollection/processingusingLabVIEW.WereadanumberofbooksthatcoveredI2CandinterfacingbetweenArduinoandLabVIEW.Despiteallofthis,ourpreviouscourseexperiencecouldnotallowustoefficientlyproceedwithArduinodesign.AlthoughthisisaBMEcourse,thisisinrealityasignalsprocessingcourse,asthedeviceandprojectasawholeheavilyrelyonsignalinterpretation.Withbriefintroductionstothistopic,wedefinitelyreliedonthehelpoftheTAsandprofessorinordertohelpbridgeourlackofexperienceinthisfield.

Time

BecausewechangedfromtheArduinodesigntoamyRIOdesignatthelastminute,wehadtoeliminatemanyofthefunctionalrequirementsoriginallyoutlinedforthedevice.Weeffectivelycompletedaprojectthatwassupposeddevelopover15weekswithina3weektimespan.Eventhoughourenddesignissimple,weareveryproudofourabilitytochangeplansatthelastminuteandstilldeliveraworkingprototype.

OperationStandardsOurproductwillhavetogothroughmultipleregulatorypathwaysbeforeweareabletomarketitdomestically:

FDA:ThereremainsdebatewiththeFDAregardingtheapprovalofwearabledevices.Becauseourdevice isonefor“GeneralWellness”and is low-risk, thedevice,similartotheFitBitsandJawbones of the world, we will not necessarily need FDA approval. This device would beavailable through retail and would not need a prescription, furthering the notion that FDAapproval is not necessary. GeneralWellness is described as a product category intended toimprovequalityoflifewithouttargetingaspecificdisease.13


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If with time the classification of wearables changes and approval is necessary, our productwouldfallsunderthecategoryofmedicaldevicesbecauseitisaninstrumentthatisused,albeitindirectly,forthediagnosis,treatment,andpreventionofadiseasethatdoesnotworkthroughchemicalaction.OurdevicewouldmostlikelyfallundertheclassIIcategory,suchasatypicalLifeAlertorothermedicalalarmproduct.Thismeansthatitisslightlyhigherriskandwillneedapremarketnotification(510k).Inthe510kapplication,wewillhavetoprovethatourdeviceisequally safeandeffectiveasa similardevice thathas thesame intendeduseon themarket;calledthepredicatedevice.The510knotificationwillestablishsubstantialequivalencetothepredicateandwill takeapproximately90days.Additionallysince it isaclass IIdevicewewillhave to have special labeling requirements, mandatory performance standards, post-marketsurveillance, non-clinical studies, and patient registries.We will continue with various otheranalyticaltools,includingSWOTandNICE.AsweentertheproductionphaseofourproductwewillhavetohaveFMEArequirementscompletetomitigateanymajorrisks intheproduct. Inorder to prevent anyhazards thatmayoccurwewill enactHACCPs to control production atdifferent locations.Most important during productionwewill haveQSRs,which are generaldesigncontrolsthatarenecessaryforsafeproductproduction.14

HIPAA: Another issue stems from the fact that thedevicewill be collecting and transmittingdata.Aswiththeissueofdeviceclassificationforwearables,theclassificationofdatacollectedby the device is a challenging one. Currently, Fitbit-likewearable devices do not need to beHIPAA compliant; however, in our situation, themedical data being collected is not just forpersonal use but also for correspondence with physicians, family members, and firstresponders. Because protected health information (PHI) is being collected and transmitted,theremaybeaneedtoensureHIPAAcomplianceforthedeviceinthelongrun.However,atthis time, there remains a lack of clarity as towhether HIPAAwould need to be taken intoconsiderationforwearabledevicesthatdonotcollectsignificantlyconfidentialinformation.15

NextStepsBecausewechangedfromanArduino-baseddevicetoamyRIO-baseddeviceatthelastminute,ourdevicetooktherouteofsimplicityforthesakeofcompletingitwithinthegiventimeframe.Assuch,wehadtoforgomanyofthefunctionalrequirementswehadoriginallyintendedtoincludeinourdevice.Whilethisdevicedoesultimatelyaccomplishthemostimportanttaskofdetectingapatient’sfallbasedonmotion,itdoesnotdosowithfinesse.Theoriginalintentionbehindthisdevicewastomakeawireless,wearabledetectorwithvitalsdetectioncapability.ButsinceweareusingthemyRIOdevice,thedetectorisneitherwirelessnorcompactandwearable.ThefirststepwouldbetoreplacethemyRIOdevicewiththemicroelectronicarchitectureofsomethinglikeanAppleWatch.WewouldalsoliketoreplacetheLabVIEWbackboneanduserinterfacewithaweb-basedormobiledevice-basedsystemasthesearemorerealisticplatformsforinteractingwiththedevice,asLabVIEWismoreofarudimentarydevelopmenttoolthatcan’tnecessarilybescaledtoacommerciallevel.

Sincewehavedonethegroundworktodevelopabasicfalldetectionalgorithmandcreateabasicuserinterfaceandalertcommunicationsystem,itwouldbeworthwhiletospendtime


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makingadevicethatelegantlyintegratesallofthesensorsandtransmitsdatawirelesslyinacompactfashionwithawaterproofhousing.Suchadevicecouldhavetremendousopportunityinthemarketfordevicesaimedtowardstheelderly.OurvisionforthisproductistocreatesomethingverysimilartoaFitbitwithadditionalfunctionalitygearedtowardsseniorcitizens.

RelevantCoursework! EE202:Courseprovidedpracticalexperiencewithcircuitdesignandanalysis.! BME416:Courseprovidedinsightastothebusinessandregulationaspectofthe

project.Somemembersofourgrouphadtakenthecourse,andtheirexperiencewashelpfulforthemarketresearchandtheregulationstandardportionsoftheproject.Thisclassalsoincludedagroupprojectthatconsistedofdesigningamedicaldevicewithdeliverablesacrossthesemester.

! BME302:Coursegaveamemberoftheteamsomepracticalexperiencewithcomputerprogrammingandinterfacingcircuits.

TeamworkThisteamexperiencewasmuchlikemostotherteamprojects.Eachmembercontributeddifferentskillsandparticipatedinvaryingcapacities.

MeetingMinutes

Date:September8,2015TeamMembersPresent:Akram,Sulekha,Isabella,MaksTime:5-6pm

Discussion:

! Weneedideasfortheproject! Ideasthatarebeingthrownoutlastfewweek

o DeviceforHome-testinghearingloss! Youngpeoplegotoconcertsnowtheirhearingisgreatlyaffectedeven

earlyoninlife.! Byhavinganaccuratehometestyoucouldeasilytrackhearinglossor

makesurethatyoudon'thaveanyhearingloss.! Biggestthingherewouldbetocreateacalibrationsothatyoucanuse

anytypeofheadphonesthatyouhavelayingaroundathome.! Everyheadphoneproducesslightlydifferentsoundsoinordertohave

accuratemeasurementsyoumighthavetoincreaseinputfrequencyorvolumeetc.

! Inordertogettheactualdesiredoutput,devicewouldbetwoparts• Calibratorandaprogramtotrackthehearingandanalyzeit.

o DetectionofDiabetesthroughacetonebreathe! Theoreticallythereisacorrelationbetweenbloodsugarandacetone

levelsinbreath


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! Debatesbetweenifthisisactuallyaccurateo Homebasedpotassiumlevelreader

! Aftersurgeriespatientshavetomonitortheirpotassiumlevels.Currentlyanurseneedstobesenttothehomeofthepatient,drawblood,sendittoalab,havealabanalyzeit,andthensendtheresultstothepatient/doctor.

o AutomaticCareforBabies! Shortageofnursesanddoctors! Self-feedingdevice?! Self-bathingdevice?! Themajorityofnursesresponsibilitywhocareforbabiesare:

• Feeding• Bathing• Changing• Talkingtotheinfants• Teachinginfantcaretoparents

! ThemoreexperiencedneonatalnurseswhoworkinaLevelIInurseryareresponsibleforprematureinfants.Theirdutiesinclude:

• Monitoringinfanthealth• Protectingbabiesfromcontractinginfectiousdiseases• Watchingforpotentialmedicalproblemssuchastemperature

shock• Performingminormedicaltreatmentsasneeded

! Maybewecanmakeadevicethatcombinesmostoftheseresponsibilitiesintoonetohelpnursesinlowstaffedhospitals

o AutomaticLifeAlert! SeniorcitizenFitBitsthatwillconstantlymonitorheartrate,blood

pressure,GPSlocation,maybemonitorsleep,anditcanautomaticallysendforhelpwhenneeded.

! Ifaseniorcitizenfallsandtheybecomeunconscious,theywon’tbeabletopushabutton.

! Therecanbeabuttonthattheusercanpresstomanuallycallforhelpwhentheyfeelliketheyareindanger.

! Constantmonitorofvitalsigns! Retrievablelocationofuser! Putsfamilymemberataneaseofmind

o EnhancementofLiftware! Stabilizeshandlingforutensils! Usedtoimprovelivesofthosewithessentialtremor,Parkinson’sDisease,

orothermotiondisorderso WearableSensorusedtoassessstandingbalanceandwalkingstability


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! Prospectiveresearchhasshownthatcommonly-usedclinicalassessmentsofbalanceandwalkinglackthesensitivitytoaccuratelyandconsistentlyidentifythosepeoplewithParkinson’sdiseasewhoareatahigherriskoffalling.

! Wearablesensorsprovideaportableandaffordablealternativeforresearchersandclinicianswhoareseekingtoobjectivelyassessmovementsandfallsriskintheclinicalsetting.

! Noconsensusonoptimalpositionforsensorso MonitoringHeartAttacks?o Gaitmonitoringo InsomniaMonitoring

! ResearchmoreandgroupwillhavetocometoadecisionbyWednesday

Date:September25,2015TeamMembersPresent:Akram,Sulekha,Isabella,MaksTime:3-5pm

Discussion:

! DivisionofUse-Case! Backgroundanddescription

o Akramwillworkonthispart! Whoaretheactorsthatwillbeaffectedbythedevice?

o Thewholegroupcameonaconsensusof5actors! Whatassumptions,constraints,andpre-conditionsneedtobemadeforthedevice?

o Discussedasagroupandfilleditouttogether! DiscussionofHappyDayScenario

o Whatthe“HappyDayScenario”iso Whatweneedtoincludeo Whatcanbeleftouto Whatthedesiredbackboneforourdeviceiso SulekhaandIsabellawillworkonthissectiono ReadandCheckedbyMaksandAkram

! DiscussionofAlternativeCaseso Whatweexpectourdevicetodothatisnotinthe“HappyDay”o Groupbouncedideasondifferentflowidentifierso Maksworkedonfillingoutthesteps

! DiscussionofExceptionFlowso Asagroup,webouncedsomeideasoffeachotherandagreedontwoflow

identifierso AkramandSulekhaworkedwillworkonfillingitout

! Artifactswerealldiscussedasagroup! FunctionalRequirementswerediscussed


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o MaksandIsabellawillworkonfillingthisportionouto Ifgroupseesanythingthatismissing,theywilladdit

! Groupwilllookoverthefinaldrafttomorrowanddiscusschangesandedits! Sulekhawilltakethefinalfinaldraftandreformatittomakeitlookpretty

Date:October6,2015TeamMembersPresent:Akram,Sulekha,Isabella,MaksTime:2-5pm

Discussion:

! DesignPresentationisnextweek.! Takerubricandanswerquestions

o CreatedaGoogleDocumenttocollaborateontheparts! Createdaflowchartforourdeviceweplantoproject! Createdanexampleblockdiagramwithloopsandstructurestodemonstratehowthe

devicemightwork! Whowillberesponsibleforwhichpart?

o SulekhawillberesponsibleforintroducingtheDevice,theBackgroundData,Definedpurposeofapplication,andExplainwhotheusersareandwhatvaluetheyderivefromthesystem.

o Makswillexplainhowtheusersinteractwithsystemtoderivesaidvalue,whatalternativeswereconsideredinprovidingthedesiredvaluetotheuser,theprocessthroughwhichcertainalternativeswereretainedwhileotherswereeliminated,whatsignalswillbemeasuredandindicatediftheyaremeasuredatthesametimeorsequentially

o Isabellawillexplainifthesignalscamefromanalogsensorsordigitaldevices,thearchitectureoftheapplication,howtheresultsoftheanalysisaredisplayedandprovedexpectedvaluetotheuser,andifthereareanyartifactscreatedbytheapplication

o Akramwillberesponsiblefordescribingthemainstepsoftheapplication,includingorganization,thedataacquisition,thedataprocessing,andthedisplayofresultstotheuser,howlongandwhatratewillbeusedforeachmeasuredsignal,andhowthesignalsareanalyzedandindicateiftheywilluseavailableroutines.

! WillfillouttheGoogledocsandfillinmissinginformationifnecessary


Discussion:! DesignReportisdueonSunday! CreatedastatemachineforthereportviaMicrosoftWord


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o Discussedasagroupwhatshouldbeincorporatedintothestatemachineo IsabelladrewoutthestatemachineonpaperwhileMakscreateditonGoogle

Doc! CreatedaGoogleDocBackbonefortheReport

o TooksomepartsfromtheDesignReviewDocumentandelaboratedonthedetails

! Wesplitupwhowillworkonwhato SulekhawillworkontheIntroduction,thecodinganddesignstructure,and

foundsomepublishedalgorithmso AkramwillworkontheHardwareDescriptionandLayoutaswellastheData

AcquisitionandConditiono MakswillfilloutthedescriptionfortheFlowDiagramo Isabellawillworkonthealternativesandconsiderations

! Wewillalsoediteachother’sworkandaddanythingthatwedeemnecessary! EveryonewillhavetheirpartsdonebySundaynightsothatwecaneditandlookoverit! Sulekhawilltakethefinaldraftandmakeitlookpretty


Discussion:

! SampleDesignCodeDueonSunday! NeedtogetArduinotowork! EveryonelookedupcodestohelptesttheADXL335(Accelerometer)

o Thecodewouldrunbuttheaccelerometerwouldoutputthewrongvalueso TriedoutmultiplecodesontheArduinocompiler

! YuHaohelpedusruntheADXL335onLabviewo Gotittoworko ButweplantouseADXL345

! YuHaoshowedushowtousetheGPSonMyRIO! GrouptryingtofigureouthowtouseArduino

Date:November3,2015TeamMembersPresent:Akram,Sulekha,Isabella,MaksTime:2-5pm

Discussion:

! Receivedorderedsensorso Heartratemonitoro ADXL345forArduino(Accelerometer)o GPSShieldforArduino


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! SulekhaworkedongettingtheADXL345toworkontheArduino! MaksandAkramplayedwiththeheartratemonitortrytogetittoworkonthe

oscilloscopeo Heartratedetectiononlyworkedoncertainpeople

! Isabellaworkedonfiguringoutwhichwiresarewhichonthegalvanicskincontact! IsabellaandSulekhatestedthefalldetectioncodeDr.Maarekfoundforusonthe

Arduinocompilero Didnotwork

! Arduinoisgivingusalotoftrouble


Discussion:

! Prototypeisdueinnextlabmeeting! Trashingproject–toodifficulttodoandwestillhavenotgottenanyofthesensorsto

workwitharduino! TransitionallsensorstoMyRIO! DivisionofLabor

o Sulekhawillbeworkingonaccelerometero Makswillbeworkingontheheartratemonitoro AkramwillbeworkingontheGPSlocatoro IsabellawillbeworkingwiththeGalvnicSkinContact

! Eachteammemberwillberesponsibleforgettingadataoutputoftheirassignedsensorbytheendofthemeeting

! CHANGEOFPLANSo WeplantostickwithArduinoo AccelerometerwasableworkthankstoYuHaoo WetriedtogettheaccelerometertoworkwiththeGPSshieldontop

o Difficultiesgettingittoworko TherewasagroundonArduino–tapedbyelectricaltapeo AccelerometerwaspoweredwithGPSshieldontopwithelectricaltape

o AttachedheartratesensorontotheGPSshieldo Analyzedataandtriedtogetrawdatatoreadandworko Abletogetthegraphtoreadrawheartratedata

o GPSsensor–triedtofindcodetopullupcoordinatesongooglemapso SuccessfullyabletogetLABVIEWtopullupgooglemapsonfrontpanelso GPSsensoroutputsrawdataindecimal

! NeedstocreateasubvithatconvertsittoASCIIcharacters! Successful!


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o NeedtotrytofigureouthowtoconcatenateaurltopullupthecoordinatesonGoogleMaps.

o Goodprogressthismeeting.

Date:November13,2015TeamMembersPresent:SulekhaTime:3-6pm

Discussion:

! SulekhametoneononewithYuhaototrytogettheArduinodevicetowork! TheybeganbyworkingwiththebasicArduinoboardandtheGPSsensor! UsingtheArduinocompilertheywereabletomakeGPSsignalconnection;however,

theyencounteredgreatchallengeswhentryingtointerfacethedatacollectedusingtheArduinowithLabVIEW

! TheissuesdealtwithUARTandTR/RX…thiswouldrequirealotmorework! Arduinoisnotabletobothsendandreceiveinformationatthesametime! ThesecapabilitiesaremakingArduinoapooroptionforfurtherdevelopment

Date:November16,2015TeamMembersPresent:Sulekha,IsabellaTime:3:30-7pm

Discussion:

! TryingtogetArduinotoworkwithsensors! Gotaccelerometerandpulsesensortoworklastmeeting! WasabletogetGPSreceivertoworkusingArduinocodebutnotwithLABVIEW! TryingtofigureoutmethodtogettheArduinocodetooutputvaluesintoLABVIEW! Arduinoquitelimitingsinceitcanonlysendsignalsinonedirection

WemadeandexecutivedecisiontoswitchovertousingmyRIObecauseit’sbeen3weeksandwehavenotbeenabletogeteven1sensortoworkusingArduino.Wehaveyettobuildthecodeforthefalldetectionortheactualdeviceyet.

! StartingtouseMyRIOtotryandgetall3sensorstoworkat4:20PM! WasabletogettheDEMOcodepublishedonlinetorun! GotthecodetopullupthelocationonGoogleMaptorun! TryingtogettheoutputoftheMyRIOGPSsystem(DEMOcode)toinputintoGoogle

MapsVIo CannothavetheGoogleMapsVIundertheMyRIOsystembecausethereisno

webbrowseronMyRIOo MovedGoogleMapsVItothecomputerwhilekeepingtheothersubvisunder

MyRIO


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o Hadtocreatevariabletocommunicatebetweenthetwoo Wasabletoestablishcommunicationbetweenthetwoandwassuccessfullyable

topullupthelocationoftheGPSsystemonGoogleMaps! WillworkonGoogleMapspinURLconcatenationathome! Tryingtogetpulsesensortowork

o Success! Tryingtogetaccelerometersensortowork

o Success! PulseandaccelerometergraphonsameSubVI! LookingtobuyGPSbatteryfromCVS–12.5mmcoincellbattery


Discussion:

! Informalprototypedemonstration! TryingtogetGPSmaptopulluptheimagewithapintoshowexactcoordinates! TryingtofindacodetoconvertpulsetoBPOM

o Foundopensourcecodeo EditeditalittlebittobecompatiblewithMyRIO

! Nowwehavetofigureouthowwearegoingtotellthedifferencebetweenwhenitisonapatientandwhenitisoffthepatientbecausethepulsesensorwillstillgiveareadingoffthepatient.

! SuccessfullyabletoretrieveBPMfrompulsedatausingopensourcecodeonbreadboard

! FoundanopensourcecodeforFalldetectionusingaplatformcalledShimmer! Tryingtofigureouthowtousetimeloop! Workedfor5hourstotrytogetthepulsesensortoworkontheMyRIOplatform

o Wouldnotplotongrapho Filteredsignalkindofweirdo Gotittoplotbutnotaccurate

! Validationtestingo GPSreceiver

! TestedGPSoutputwiththeGPSreceiver• PulledupamapwithapinatDRB

! TestedtheURLwiththecoordinatesfromtheEmpireStateBuilding• PulledupamapwithapinattheEmpireStateBuilding

o HeartRate! SubjectA–AkramKhan

• MeasuredBPMusingpulsesensor:64BPM• MeasuredBPMusingbloodpressuredevice:63BPM


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! SubjectB–YuhaoPeng• MeasuredBPusingpulsesensor:98BPM• MeasuredBPMusingbloodpressuredevice:96BPM

Date:November23,2015TeamMembersPresent:Sulekha,IsabellaTime:3:30-8pm

Discussion:

! Tryingtogetaccelerometer/falldetectortowork! Testedouttwodifferentfalldetectionsystem! Accelerometerisoutputtingdata! Falldetectedinthefrequencydomain! Needtofigureouthowtodetectthefallinthewaveletdomainsothatitwillbemore

accurate! 2typesoffall–weakandstrong! Abletogetbothdomaintodetectfall! Settingupsothatwhenafallisdetected,itwillaskuseriftheyneedhelpandsendan

emailo Popupwindowismisaligned,toolong

! Quickfix! Changed“callforhelp”to10second

! WanttogetthehelptosendandemailwiththeURL! URLhassmallbugs

o Fixedsothatitoutputsnowhitespace! Accelerometerandfalldetectionsystemnowworksperfectly

Date:November24,2015TeamMembersPresent:Akram,Sulekha,IsabellaTime:2-9pm

Discussion:

! Falldetectorworksperfectly! GottogetHeartratetoworknow! Goalfortheday:getpulseratetooutputanaccurateBPMandstartputtingthedevice

together! Pulsereadingisnotcontinuous! Trytofigureoutbug

o Runningdataacquisitionwithoutallthepeakdetection/BMPconversionjunko Runningdataacquisitionthroughbandpassfiltertoseeifthat’stheproblemo LookforWaldo

! Trashopensourcecodeanddoourownanalysisofrawpulsedata


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o CollectDatao Findthresholdofeachpulseo Transformitintoasquarewaveo Usepeakdetectiono ConverttoBPM

! FoundBPMbutnotveryaccurate! Veryfluctuating! Needtofigureoutwaytolowerthefluctuation

! Workonfrontpanel/portal! PutGPSsystemintoaccelerometersystem! Makefrontpanellookpretty


Discussion:

Whatneedstobedonethisweek:! DevelopmentofaVIthatwouldallowustocollectandstoreapatient’spersonal

informationdata:Name,Age,Gender,EmergencyContact,etc.sothatwecansendthisinformationoutwiththealert.Wewillneedtocreateaninterfaceforafirsttimeuserandarepeatuser.Inthecaseofthelatter,patientinformationwillneedtobereadfromafile.Thisexcelfilewiththisinfoshouldbesavedonthesameflashdrivethathaseverythingelse.Update:wewillnotbeusingDropbox/thecloudforanything,asitisunnecessary.Wewillthenneedtointegratethisnamestuffintothewarningemailsentuponafall.

! WeneedtoautomaticallyopentheGPSdatacollectionandtheAccelerometerdatacollectionVIsupondeviceactivation/runningtheMainVI

! CreationofabuttononLabVIEWthatwouldallowthepatienttosenddistressemailondemand.

! Waytoeffectivelyturnthesystemonandoff…buttonmightnotwork.! Commenting/organizingeverythingsothatitbecomeseasyforMaarektograde.! Validationtestingofthesensors.GPSandfalldetectionareeasy.HRisreallymessedup

atthispoint,sowefirsthavetogetthesensorworking.Accomplishedtoday:

• GottheheartratemonitortomoreaccuratelythankstoDr.Maarek• Addedabuttononthefrontpaneltoturnonandoffthesystem• Createdabuttonandsubvithatwillallowthepatienttomanuallyrequestforhelp• Spent1½hourtryingtogetthemainVItoopenthedataacquisitionwindowsandrun

them"failed


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• Workingonpatient’spersonalinformationinput"cannotgetthedatatosavecorrectly

Date:December1,2015TeamMembersPresent:Akram,Sulekha,Isabella,MaksTime:2-6pm

Discussion:

! ThemaintasktofocusontodaywastogetthemainVItopullupthethedataacquisitionVisandrunit

o WepostedaquestiononNationalInstrumentsandgotaresponse,howevertheyleftbeforewegotacompleteanswer

o LookedonGoogletoseeiftherewasamethod–didn’tworko TriedwhatwedidinclasswithinvokenodesbutwhenitpullsuptheVI,itis

pulledupinMyComputersinsteadofMyRIOandthereforecannotrun.! Decidedthatweshouldjustrunthemmanuallyandhavethemcontinuouslyruninthe

background.! Secondtasktodaywastryingtoworkouthowthepatientisgoingtoentertheir

informationintothesystem.o Needtogetittobasicallyhave

! Areadfiletoseeifafileisinexistence.Ifitdoesn’twewillhavethepatiententertheirinformation,ifitdoes,thenwejustproceedtothemainVI

! Aninputwindow! Savethepatientinformation! Readthepatientinformationandbeabletopullouttheinformation

! GotaVItoinputthepatientinformation! Gotittosaveinformation! Havingtroublewithreadingthefileandoutputtingthedata

Date:December2,2015TeamMembersPresent:Sulekha,MaksTime:10-2pm

Discussion:

! Themajorobjectivewastogetthepatientinformationread/writeVIstooperateproperlyuponactivationofthedevice:

o Thisincludedfindingapaththatwouldautomaticallysavetheinputtedpatientinformationtoapre-determinedfile.

o MakingsurethatthemainprogramdidnotprompttheuserforpatientinformationoncePIhadalreadybeenrecorded

o Makingthepatient’semergencycontacttherecipientofthedistressemail


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o Integratingthepatientinfointotheemergencyemailthatwassenttotheemergencycontact

! WealsowantedtocreateaneasierwaytorunallthreeofthemyRIOViso Inordertodothiswecreateanotherblankvianddidnothingbutdragthesubvis

ontotheblockdiagramo Whenwerunthisextravi,itautomaticallyopensandrunsthethreedata

collectionVisonmyRIO! Wealsofilmedthevideoforthisproject! TheProjectFolderwascleanedupandtheprogramwasannotatedtofacilitatein

understandingthecode

Date:December4,2015TeamMembersPresent:Sulekha,IsabellaTime:6-9pm

Discussion:

! Sincetheprojectisbasicallycompletedwecameintothelabtotakescreenshotsofeverything

! OnethingwediddowasslowdowntherefreshfortheGoogleMaponthefrontpanelo ThiswasimportantbecauseGooglehasalimitonthenumberofmapsthatcan

besourcedperIPaddresso Byslowingtherefreshtimewecandemoourdeviceforalongerperiod

References1"ComingSurgeinHousingNeedsoftheOlderElderly."FannieMaeDataNote2.3(2012):n.

2"AdministrationonAging(AoA)."AgingStatistics.USDepartmentofHealthandHumanServices,n.d.Web.10Sept.2015.<http://www.aoa.acl.gov/Aging_Statistics/index.aspx>.

3Monroe,Robert."TheEffectofAgingofPopulationonGeneralHealthProblems—NEJM."NewEnglandJournalofMedicine249(1953):322-28.NewEnglandJournalofMedicine.NEnglJMed,20Aug.1953.Web.11Sept.2015.<http://www.nejm.org/doi/full/10.1056/NEJM195308202490805>.

4"OlderAdultFalls:GettheFacts."CentersforDiseaseControlandPrevention.CentersforDiseaseControlandPrevention,01July2015.Web.11Sept.2015.<http://www.cdc.gov/homeandrecreationalsafety/falls/adultfalls.html>.

5"LatestAlzheimer'sFactsandFigures."LatestFacts&FiguresReport.Alzheimer'sAssociation,17Sept.2013.Web.11Sept.2015.<http://www.alz.org/facts/>.


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6"BoostingSurvivalRates--OccupationalHealth&Safety."BoostingSurvivalRates--OccupationalHealth&Safety.OccupationalHealth&Safety,01June2005.Web.11Sept.2015.<https://ohsonline.com/Articles/2005/06/Boosting-Survival-Rates.aspx>.

7Bilton,Nick."TheHealthConcernsinWearableTech."TheNewYorkTimes.TheNewYorkTimes,18Mar.2015.Web.11Sept.2015.<http://www.nytimes.com/2015/03/19/style/could-wearable-computers-be-as-harmful-as-cigarettes.html?_r=0>.

8Otto,C.A.,etal.(2009).WearableHealthMonitoringDeviceandMethodsforFallDetection,GooglePatents.<https://www.google.com/patents/US20090048540#forward-citations>.

9SZETO,C.C.F.B.F.(2015).Devicesandmethodsforheart-ratemeasurementandwrist-watchincorporatingsame,GooglePatents.<http://www.google.com/patents/EP1641388B1?cl=zh>.10"GoSafe."Philips.PhillipsLifeline,n.d.Web.11Sept.2015.<http://www.lifeline.philips.com/safety-solutions/gosafe>.

11"DurableMedicalEquipment(DME)Coverage."Medicare.gov.Medicare.gov,n.d.Web.11Sept.2015.<https://www.medicare.gov/coverage/durable-medical-equipment-coverage.html>.

12"MedicareandMedicalAlertSystems."Medicare.com.EHealth,20Sept.2014.Web.11Sept.2015.<https://medicare.com/medicare-coverage/medicare-alert-systems-medicare-cover/>.

13FoodandDrugAdministration.GeneralWellness:PolicyforLowRiskDevices.FoodandDrugAdministration,11Sept.2015.Web.11Sept.2015.<http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery>.

14"U.S.FoodandDrugAdministration."PremarketApproval(PMA).U.S.FoodandDrugAdministration,1Oct.2002.Web.11Sept.2015.<http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/>.

15"WearableHealthTechnologyandHIPAA:WhatIsandIsn'tCovered."SearchHealthIT.TechTarget,n.d.Web.11Sept.2015.<http://searchhealthit.techtarget.com/feature/Wearable-health-technology-and-HIPAA-What-is-and-isnt-covered>.

LinktoDeviceDemoVideo:https://youtu.be/UWfUmtnM_H4

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