Documente Academic
Documente Profesional
Documente Cultură
Class:BME2910
Semester/Year:Fall2015
Departmentof
BiomedicalEngineering TravisSwiantek,IshaKulkarni,DavidTes,Emma
WayneStateUniversity Burgin
DesignHistoryFile
Project:
AutocorrectingBloodPressureCuff
UserNeedsSummary:
Accurate
Mustautocorrecttodisplay
accuratereadingand/orbeableto
recognizeaninaccuratereading
Comfortable
Lightweight
Durable
Portable
Easytouse/clear/intuitiveinstructions
Accommodatingforvariousclients
Resultseasytoread/interpret
Detaileddatarecordingandanalysis
withindevicestorage(for
doctor/nurse/caregiver)
Deviceflagseachtimethereisan
abnormalreading
Efficientbatterywithlonglife
Inexpensive
GoalsandObjectives:
Thedevicemustbeabletoaccurately
measureapatientsbloodpressure,and
accountforthevaryingpositionsand
placementsofthedevicebythepatient.
Thedeviceshouldbecomfortableforthe
patient.Itshouldalsobelightweight,durable,
andportableforgreaterusability.
Instructionsprovidedbythedeviceshouldbe
clearandeasytofollow.
Resultsshouldbedisplayedinamannerthat
iscleartotheuserandeasytointerpret.
Datashouldalsobeprocessed,stored,and
displayedquickly.
Anystoreddatashouldbecompleteand
detailedsothatitmaybeeasilyanalyzedby
adoctor,nurse,orcaregiver.
Thebatteryofthedeviceshouldbe
inexpensiveandlonglastingforthe
convenienceoftheuser.
Thedeviceshouldalsobeaffordableenough
foruserstopurchaseindependently.
DesignInputSummary:
Hasanaccuratereadingwithamarginof
errornogreaterthan2.0%
Beabletorecognizeaninaccurate
readingandinformtheuser
Shellmadeofdurable,inexpensiveplastic
InflatableCuffmadeofsoft,flexible,and
breathablematerial
Weighslessthan450g
DesignOutputSummary:
Inclusionofsensorsinthecuff/deviceto
monitorforcorrectpositioningofarmduring
reading:Pressuresensors,gyroscopes,
accelerometers
Autocorrectionalgorithmincorporatedinto
software
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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Lastsatleast5,000uses
Displayshouldbereadablefromupto3ft
awayfromuser.
Wristcuffaccommodatesaveragewrist
circumference:18to25cmaround
Supplementalinformationshouldprovided
tohelpunderstandresults
Datashouldbestoredinadocumentor
spreadsheetandshouldcontainat
minimumthedate,time,anddiastolic
andsystolicvalues
Deviceshoulddetectabnormalitiesin
rhythmorreadingsbasedoncomparisons
topreviousreadingsandcurrentvalues
Batteryshouldlast1+years
Thedeviceshouldcostnomorethan$200
totheuser
Cufftobemadeoutofnylon/lycramaterial
asthatisstandardtocuffsandwillprovide
easymaintenanceandcomfort
Powersourcewillbearechargeableinternal
batterythattakesadvantageof120V
householdoutlets
DatawillbestoredinInternalmemory,tobe
accessedondevicetodownloadableviaUSB
ormicroport
Wireless/Bluetoothintegrationforquick
downloadofdatatoseparatedeviceor
computer
Devicewillhavecodethatwillselfevaluate
todetectabnormalreadingsfromthe
patient'snorm
DesignVerificationSummary:
Nyloncuffpurchasedfromexternalvendor
4RechargeableCoinCellBatteriesfor
14.4Voutput
Touchscreendisplay(95.0453.86mm)
4GBFlashMemorystorage
3axisGyroscopesensor(BMG160)for
position
DesignReviewSummary:
Reviewerswereaskedtofocustheirreviewon
thefollowingpoints:
Autocorrection
PhysicalDesignConcepts
DataOutput,Display,Storage
Designreviewaudienceincluded:peers,our
client,professionalbiomedicalengineering,and
biomedicalengineeringinstructors.
DesignChangeSummary:
Thedesigninputandoutputwereupdatedinthe
followingways:
Thedevicewillbeawristcuffonly
Thescreenwillbefixedtothedevice
Therewillbemultiplesizeoptionsto
accommodateusers
PlansforFutureDevelopments:
Validationofsoftwareforfunctioningand
autocorrectionalgorithm
Prototyping
Userandphysiciantrialswithprototype
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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TableofContents
Background......................................................................................
ProblemStatement........................................................
DesignInput......
UserNeeds...
DesignSpecifications......
DesignDevelopment....................................
DesignTools............
DesignReview.......................
13
DesignChanges......
15
DesignOutput.........
16
Verification..........
19
FuturePlans.......................................................................................
20
Validation............
20
References.......
21
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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Background
Homebloodpressurecuffsareapracticalmeansforuserstobemoreconsciousoftheirhealth
status.Attimesphysiciansmayinstructapatienttopurchasetheirownhomebloodpressure
monitorinordertotakemeasurementsathomeandmonitortheirstatus.Doctorsofteninstructtheir
patientstodosowhentheyareoverweight,hypertensive,elderly,pregnant,diabetic,orbeginning
newcardiovascularmedication.Whenpatientsmonitortheirbloodpressureathome,ithelps
doctorsunderstandanddiagnoseproblemsthatpatientsarehaving,evenoutsideoftheclinical
setting.
ProblemStatement
Currentlyonthemarket,therearevariousathomebloodpressuremonitorstochoosefrom.The
mostreadilyavailablemodelsarethewristbloodpressuremonitors.However,theprocedurein
whichthesebloodpressuremonitorsaremeanttobeusedisinconsistentbetweendevices.This
canleadtoconfusionanderrorswhenpatientsdonotrealizetheyhavebeenusingtheirdevicein
anincorrectmanner.Forexample,apersonwhohasseenawristbloodpressurecuffusedwith
theirarmat45degreesmayassumethatallwristcuffsrequiretheirarmtobeat45degrees,when
inrealitythedevicetheypurchasedmayrequiretheirarmtobeacrosstheirhearttogetanaccurate
reading.Thediscrepancyinarmpositionwillleadtoinaccurateresults.Thiscanbequite
dangerous,aspatientsneedtoensurethattheyareobtainingaccuratebloodpressure
measurementstomonitortheirhealth.Therearesomemedicationsthatexistthatrequirepatientbe
withinaspecificbloodpressurerangeinordertotaketheirmedication.Aerroneousbloodpressure
monitor,oronethatisusedincorrectly,couldthereforcausepotentiallylifethreatening
consequencesifthepatientusesafalsereadingtodirecttheirmedicaldecisions.
Figure1:
Varyingarmorientationsforbloodpressuremonitors.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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Solution
Thereisneedaforamoreuniversalbloodpressurecuffthatcanaccommodatethesevariousarm
positionsandeliminatepotentialerrors.Thedesigninthisdocumentaimstoestablishsucha
device.Thereisroominthemarketforadevicethatwilleffectivelyautocorrectbloodpressure
readingstoimprovetheaccuracyofthepatientsresults.Inthisway,healthcareprofessionalscan
bemoreassuredthatpatientsarerecordingcorrectreadings.Patientsalsowillbemoreempowered
andautonomousiftheyknowthattheyareusingareliableandaccuratedevice.
DesignInput
UserNeeds
TheAutocorrectingBloodPressureCuffallowsforuserstotakebloodpressurereadings
withutmostaccuracyhowevertheypositiontheirarmwhenthedeviceisplacedcomfortablyand
correctlyontheirwrist.Inordertoestablishthefundamentaldesigngoalsandconstraints,aclient
interviewwasconductedtodeterminethespecificuserrequirementsforthedevicewithanurseat
MacombOaklandAdultMedicinewhohasexperiencewithdevicessuchasthese.Thenewdevice
shouldmeetthespecificneedsrequiredbyhealthcareprofessionals,butmustalsobeusableand
accessibletopatientsandeverydayindividuals.Afterreviewingtheclientresponses,thefollowing
needswereestablished.Thedevicemustbe:
Accurate
Mustautocorrecttodisplayaccuratereadingand/orbeabletorecognizean
inaccuratereading
Comfortable
Lightweight
Durable
Portable
Easytouse/clear/intuitiveinstructions
Accommodatingforvariousclients
Resultseasytoread/interpret
Detaileddatarecordingandanalysiswithindevicestorage(fordoctor/nurse/caregiver)
Deviceflagseachtimethereisanabnormalreading
Efficientbatterywithlonglife
Inexpensive
Thedevicemustbeabletoaccuratelymeasureapatient'sbloodpressure,andaccountfor
thevaryingpositionsandplacementsofthedevicebythepatient.Thedeviceshouldbecomfortable
forthepatient.Itshouldalsobelightweight,durable,andportableforgreaterusability.Any
instructionsprovidedbythedeviceshouldbeclearandeasytofollow.Resultsshouldbedisplayed
inamannerthatiscleartotheuserandeasytointerpret.Datashouldalsobeprocessed,stored,
anddisplayedquickly.Anystoreddatashouldbecompleteanddetailedsothatitmaybeeasily
analyzedbyadoctor,nurse,orcaregiver.Thedeviceshouldalertthepatientifthereisanespecially
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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abnormalreading.Thebatteryofthedeviceshouldbeinexpensiveandlonglastingforthe
convenienceoftheuser.Thedeviceshouldalsobeaffordableenoughforuserstopurchase
independently.
DesignSpecifications
Designspecificationsarethefunctionsandpropertiesthatthedevicemustbeableto
provide.Thesecanbeconsideredconstraintstotheinputsofthedesign,andmustbefulfilledin
ordertomeetrequiredstandardsandnecessaryfunctions.
Thedevicewillbeusedwithintheusershometotakeaccuratemeasurementsoftheusers
bloodpressure.Theproductwillbeusedontheclientswristandwilltakeanaccuratereading
dependingonhowthedeviceisplaced.Thedevicewillprimarilybeusedbythepatient.Thedevice
willprimarilytreatpatientswithhypertension,diabetes,andobesity,adultsover60,andpregnant
women.
Hasanaccuratereadingwithamarginoferrornogreaterthan2.0%
Beabletorecognizeaninaccuratereadingandinformtheuser
Cuffmadeofsoft,flexible,andbreathablematerial
Weighslessthan500g
Lastsatleast5,000uses
Displayshouldbereadableupto3ftawayfromuser.
Cuffvariestoaccommodatewristsize
18cmto25cmlength
Supplementalinformationshouldprovidedtohelpunderstandresults
Datashouldbestoredinadocumentorspreadsheetandshouldcontainatminimumthe
date,time,anddiastolicandsystolicvalues
Deviceshoulddetectabnormalitiesinrhythmorreadingsbasedoncomparisonstoprevious
readingsandcurrentvalues
Batteryshouldlast1+years
Thedeviceshouldcostnomorethan$200totheuser
Thedeviceshouldtakemeasurementsthatareaccuratewithina2.0%marginoferrorinordertobe
consideredaccurateandreliable.Thedeviceshouldbeabletoinformtheuserofaninaccurate
readingsothattheuserdoesnotskewtheirowndata.Thecuffwillbecomfortabletotheuserasit
willbemadeofasoft,flexible,andbreathablematerial.Toremaincomfortableandportable,the
entiredevicewillweighlessthan500g.Thedevicewillbedurableenoughtolast5,000uses,or
about6yearswithanaverageof2usesperday.Theuserwillbeabletoclearlyseetheresultson
thescreenfromupto3feetaway,wellwithinarmlength.Thewristcuffwillbeaccommodatewrists
between18to25cmincircumference.Inordertominimizeusererror,supplementalinformationwill
beprovidedtohelptheuserunderstandtheresultsofeachreading.Datafromeachreadingwillbe
storedwithinthedevicesothatamedicalprofessionalmayeasilylookbackatthepatientsrecent
history.Thedevicewillbeabletocomparepreviousresultstocurrentresultsandalerttheuserand
noteintherecordeddatawhentheuserhasanabnormalreading.Thebatteryofthedevicewilllast
overoneyearforuserconvenience.Asthedevicecostwillunlikelybecoveredbytheusers
doctorsofficeorinsurancecompany,thedevicewillcostunder$200topurchase.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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DesignDevelopment
DesignConceptDevelopmentSummary
Indevelopingthedesign,anumberoftoolswereutilizedtoorganizeideasandarrangetheminto
differentdesignconcepts.First,anunorganizedlistofover70brainstormedideaswasmade.Using
these,commonthemeswereappliedandtheideaswereorganizedintoaconceptmap.Theideas
fromtheconceptmapwerethenaddedintoamorphologicalmatrixdescribingthevariousoptionsof
devicefeaturesandfunctions.Furthermore,aseparatemorphmatrixwasutilizedtocreatesix
uniquedesignconceptsforthedevice.Finally,thedesignideaswererankedbasedonimportance
inaPughmatrix,fromwhichtwodesignswerefoundtomeetspecifiedrequirementsmost
effectively.Thefourprecedingdesignprocessesarefurtherexplainedinthissection.
ConceptMap
Aftergeneratingalistofover70ideasforthedesign,aconceptmapwasusedtoorganizethought
processesanddeterminetheaccessoryandmainfeaturesthatcouldbeimplementedintothe
device.Fourmaincategorieswereestablished:usability,functions,customization,andefficacy.
Usabilityexploredesignconceptsrelevanttotheuserthatcouldimproveeaseofuse.Theprimary
functionsthatwedeterminedwereautocorrectionanddatastorage,andallotherfunctionscome
secondarytothese.Efficacyexplorespowerefficiencyandadditionalfeatures,andcustomization
wasextrafeaturesthatcouldenhancethedesignandaesthetic.Theinitialconceptwastocreatea
designthatwouldbecomeasolutiontoincorrectbloodpressurereadings,butalsobeabletostore
andanalyzereadingsovertimeforpatientsthatusethedeviceregularly.Theconceptmapcreated
forthisdesigncanbeseeninFigure2.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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Figure2:
ConceptMapofIdeas
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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MorphMatrixofFunctions
Themorphmatrixoffunctionswaswhatdeterminedwhatmajorfeatureswouldbeimplementedin
thefinaldesignedproduct.Themostimportantoftheseistheautocorrectingfeatureofthedevice
anduseofagyroscope,anaccelerometer,andpressuresensorstoachievetheautocorrecting
feature.Inadditiontotheautocorrectingfeature,thereisalsoawirelessconnectivityfeaturewhich
canbeachievedwithaBluetoothsystemortransferringofdataviaUSBormicroSDcard.Withthis
methodofdatatransfer,storageandanalysiscanbeeasilyachievedandeachindividualusercan
monitortheirbloodpressureandkeeptrackofaveragesandpeaksoveragivenperiodoftime.
Anotherfunctionalfeaturethatmaybeimplemented,whichexistsinthematrixisvoicegiven
instructionsforuseorwritteninstructions.Theseinstructionsareveryimportanttothedesignsince
oneofthemajorissueswithcurrentlymarketedbloodpressuremonitorsisthatusersareusingthe
deviceincorrectlyduetoinconsistentmethodsoftakingbloodpressurewithvariousdevices.
TableI:MorphologicalMatrixofFunctions
Function
Option1
Option2
Option3
Option4
Option5
Display
Touch
Display
Detachable
Interface
Bluetoothtoother
devices
Detachable
Display
PressureCuff
Instructions
On/from
device
Pamphlet
OnBox
Online
Voice
DataOutput
Graphs
Numbers
Colors
Audio/Voice
DataStorage
MicroSD
card
Internal
Memory
FlashDrive
Microchip
EnergySource
AAA
Batteries
Plugincharger
SolarPowered
Customization
Multiple
User
Changeable
Bands
HealthProfile
Adjustable
display
(font,text
size,etc.)
Accessibility
AdditionalFunctions
HeartRate
Monitoring
Blood
Glucose
Monitoring
PulseOximetry
AdditionalAccessibility
ofData
Alertto
Physician
Sendto
printer
Connectto
Smartphone/App
Bluetooth
Bump
Technology
MorphMatrixofDesignOptions
WithintheMorphologicalMatrixuptofiveoptionswerelistedforeachfunction.Thisallowedforthe
maximumdesignpossibilitiesandanoverallideaofwhatwouldbestworkforthedesignconcepts
ourgroupwishedtopursue.Functionsrangedfromdisplay,instructions,energysource,storage,
customization,andmore.Whenlistingoptionsforeachofourfunctions,ourgroupattemptedto
categorizethebestfeasibleoptionstogetherinordertorationalizethemostrealisticandacceptable
device.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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TableII:MorphologicalMatrixofDesignOptions
Function
Design1
Design2
Design3
Design4
Design5
Design6
Display
Touch
Display
Detachable
Interface
Touch
Display
Bluetoothto
otherdevice
Connected
displayto
computer
Detachable
display
Instructions
Voice
On/from
device
On/from
device
Pamphlet
Ondevice
display
Voice
DataOutput
Numbers
Numbers
Graphs
N/A
Numbers
andGraph
Analysis
Numbers
andGraph
analysis
DataStorage
MicroSD
card
Internal
Memory
MicroSD
card
MicroSD
card
Internal
Computer
Memory
Internal
memory
EnergySource
AAA
Batteries
Plugin
charger
AAA
Batteries
Plugin
charger
Plugin
Plugin
Customization
Multiple
User
Health
Profile
Adjustable
display
(datatype,
font,text
size,etc.)
Changeable
Bands
Themesfor
computer
software
Adjustable
display
Additional
Functions
HeartRate
Monitoring
None
HeartRate
Monitoring
None
HealthTips
None
Additional
Accessibilityof
Data
Connectto
Alertto
Smartphone/ Physician
App
Sendto
printer
Connectto
Smartphone
/App
Cloud
Storagefor
remote
accessibility
Connectto
smartphone
/app
Designoption1:
Manyofthesefunctionswereselectedineffortstoappealtomodernaesthetics
andutilizecurrenttechnologiesavailable.Havingvoiceguidedinstructions,touchscreendisplay,
heartratemonitoringandsmartphonecompatibilitywillallowforbetterusabilityandimprovethe
userexperience.
Designoption2:
Thisideaincorporatestheuseofadetacheddisplaywithvoiceinstructionstothe
client.Thehopeofthiswouldbetoimprovetheeaseofuseofthedeviceforthepatient.Thisstand
alonebasecouldthenhaveportstoconnectdifferentcablesforbothcharginganddatacollection,
orcouldevenbepassedontothehealthcareprofessionalforanalysis
Designoption3
:Thiscombinessomeofthebetteraspectsofthefirsttwodesignoptions.Allowing
fortheadjustabledisplaytoeithershowatimelineofrecordingsaswellastheoptiontoswitchback
todatacouldimprovetheuserexperience.Sendingthedatatoaprinterwouldallowusertoeasily
providehealthcareprofessionalswiththedataduringclinicalappointments.
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Designoption4:
Thisconceptwouldattempttoeliminatetheneedforexternalscreensandtake
advantageofexistingtechnologiesthatutilizeapps.Thiswouldhopefullyallowthedevelopmentofa
smallerdevicethatcouldhaveportstoconnectanddownloaddata,aswellaschargethedevice.
Thedevicecouldbemarketedasabloodpressurecuffhealthaccessorytobeusedwith
smartphones,andcouldreachabroaderdemographicofhealthconsciousindividuals.
Designoption5:
Thisdesignoptionallowsfortheusertotaketheirbloodpressurereadingsonthe
largerscreenofthecomputerorexternalscreen.Italsoallowstousethefunctionalityofthescreen
toactasasanalternatedisplay,memorystorage,andconnectiontocloudstorageandanother
computersystemthatcanexistinahospital.Thiswouldallowtheactualcufftobeamoresimple
design,andmostoftheworkachievedwouldbedonebythesoftwareexistinginthecomputer.
Designoption6:
Thisdesignallowsfortheusertodetachthedisplayfromthecuff,withthe
intentionofthepatienttotakethedisplaytotheirappointmentstosharedatawiththeirphysicians.
Theuserwillbegivenaudioinstructionsfromthedevice.Thedatawillbedisplayedinnumbersand
graphsontheinterface.Datawillbestoredwithinthedeviceandwillbeabletosenddatatoa
smartphoneorapp.Thedevicewillbepluggedintoawalloutlettocharge.Thedetachabledisplay
willbecustomizablesothepatientcanviewthedatainawaymostconvenienttothem.
PughMatrix
ThePughMatrixbelowisacleardescriptionofhowourpreliminarydesignscametobe.Withinthe
PughMatrix,ourdesignconceptswerelistedwithacleardescriptionofwhatwasneededinorderto
haveanacceptabledevicewithinthemarketplace.Oncethatwasdecided,apriorityrankingwas
giventoeachdesignconceptwithavalueofonethroughfive.Thehigherthenumberstatedthat
thatdesignconceptrequiredgreatattentionwhendesigningourdevice.Abaselineofthreewas
giventostatehowtheeverydaybloodpressurecuffusedinthemarkettodaywouldrankinthe
PughMatrix.Afterassigningaranktoourfollowingdesignoptions,itwasrecordedthatdesign
option5and6reachedthehighestperformancecapacityastheyacquireda90%and87.3%
efficiencyrating.
Oncethefinalrankingsofourdesignoptionswerecalculated,apreliminarydesignwascreatedfor
designoption5anddesignoption6.
Weight/Numericalrankingisbasedona1to5scale,with5beingthehighestvalue.
Thebaselinepriorityrankingisa3.Thebaselinemodelisahospitalgradebloodpressure
cuff/marketbloodpressurecuff.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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TableIII:PughMatrixRankingofDesignOptions
DesignConcepts
Weight
(Priority
Ranking)
Baseline
Design
Option
1
Design
Option
2
Design
Option
3
Design
Option
4
Design
Option
5
Design
Option6
Hasanaccuratereadingwith
amarginoferrornogreater
than0.5%to2.0%
Wristcuff18to25cmlong,
5to7cmwide
Upperarmcuff35to45cm
long,12to15cmwide
Devicedatamustbeeasily
accessible/retrievable
Portability:Weightlessthan
150g
Deviceshoulddetect
abnormalitiesinrhythmor
readingsbasedon
comparisonstoprevious
readingsandcurrentvalues
EnergyEfficiency
Provideunderstandable
instructionstouser
Maintainauserprofileof
readings
OptimalReadableDisplay
110
66
80
86
77
66
99
96
60%
70%
60%
90%
87.3%
TotalRankScore
PercentageofEfficiency
72.7% 78.2%
PreliminaryDesignConcept
BasedonaPughMatrixanalysisof6differentdesignconcepts,twodesignoptionwerefoundto
meetthegoalsandconstraintsdiscussedinthedesigninputbetterthanotherconcepts.Thosetwo
designwerethenreevaluatedandnewdesignencompassingthebestandmostpracticalfeatures
ofthetwoweremaintain.Thefollowingistheconceptofthatfinalpreliminarydesign.
DesignConcept
Theintentionofthefirstdesignistoallowtheusertoremovethedisplayfromthecufftotakewith
themtotheirappointmentstoeasilysharedatatheyhavecollectedathomewiththeirphysicians.
Datawillbedisplayedinbothnumbersandgraphsontheinterface,andwillbestoredwithinthe
deviceforeasysharingwithdoctors.Theuserwillalsohavetheoptiontosenddatatoa
smartphoneorapp.Theuserwillbegivenaudioinstructionsfromthedevice.Thedevicewillbe
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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pluggedintoawalloutlettocharge.Thedetachabledisplaywillbecustomizablesothepatientcan
viewthedatainawaymostconvenienttothem.
PreliminaryDesignSketches
Figure3:P
reliminaryDesignConcept
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DesignReview
AdesignreviewcompletedonDecember10,2015.Forthis,apresentationofthedesignwas
preparedandanaudienceofpeersandprofessionalswasinvited.Amongtheseincluded
BiomedicalEngineeringstudents,aregisterednurse(ourclient),aprofessionalbiomedical
engineer,andseveralbiomedicalengineeringinstructors.Forthisreview,theaudiencewasasked
tofocustheircritiquesonthreemajorpoints:
1. Autocorrection
2. DesignConcepts
3. DataOutput,Collection,andStorage
Thequestionscommentsandfeedbackfromthissessionallowedustorealizesomeshortcomings
inthedesign,andtheareasthatrequiredmorefocus.Thefollowingsectionswillhighlightthe
commonconcerns,andourrecommendationstoaddresstheissue.Intableiv,thesummaryof
concernshavebeenorderbyorderofpriority.
TableIV:SummaryofDesignConcerns
Common
Questions
and
Concerns
1.Autocorrection:
Designwillflaginaccuratereadingshowwillthedevicedeterminethis?
Thedeviceshouldnotcontinuallytelltheuserthattheirreadingwaswrongbecauseit
wouldcausefrustration...
Whatdoesdeviceflagsmeans?
Howwillthegyroscopeknowhowtoadjustthereadingsbasedonlocation?
howwouldyoutellifthereisanerror?isthisbasedoffabaseline?
Fortheaccuracyalgorithm,Iwouldhaveastepwherethedevicechecksitselftoseeif
theinaccuratereadingwasduetothedeviceandnottheuser
whatiftheuserisexperiencingaconditionwheretheyactuallyhavehigherorlower
bloodpressurethanwhatisnormalforthem?
2.Physicaldesign:
Isthereenoughroomforallthemechanisms/wires/computerwithinthedesiredsize?
Deviceseemslikeitcanbesimplifiedtoproduceabetterdevice.
Thepictureofthecuffitselfwasveryvague.
3.Screen:
Itseemslikeitwouldbeanextrahassletotrytofigureouthowtoattachanddetacha
screen.
Havingthedetachablescreenseemstomakethedevicemorebulkythanitneedstobe.
Thedetachablescreenseemslikeitcouldbemoreofahassle.
Whywasitnecessarytoremovethescreenfromthedevice?
Wethinkthatthedesignwouldworkeffectivelyexceptfortheideaoftheremovalscreen.
4.Battery:
Iquestionifthebatterywillbesufficienttorunallofthosefeatures
5.DataOutputandFeatures
Whyshouldthedevicebereadfrom3feetaway?
Readabilityfromuptothreefeetseemsmuchmorethannecessaryfortheinput.
...willthe4GBmemorybeenough?
Willitbesimpleenoughforanathomeusertoutilize?
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
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1. Autocorrection
Mostofthequestionswereinregardstotheautocorrectionandpossibleflawsintheerrorreporting
diagnosticaspectofthedevice.Acommonconcernwasthattherecouldbemultipleerrorreportsas
aresultofanabnormalreading,whichcouldbealifethreateningsymptomorerrorofthedevice
itself.Questionsregardingthesoftware,sensors,andalgorithmallhighlightedtheneedtofurther
establishhowthissensorswillimprovethefunctioningofthedevice.
Theseconcernsareoftheutmostpriority,astheyareinregardstothemainmotivationofthe
design.Toaddressthis,therewillneedtobeanextensiveresearchandvalidationplanningto
ensureproperfunctioning.Usertestingwillbeanessentialpartofprimaryresearcheffortsto
addresshowusersrespondtothedevice,andhowaccuratethedeviceis.Thealgorithmwillbe
improvedtoincorporatewhetherthedeviceisinerror,oriftheerrorisduetotheuser.Researchwill
beconductedtodetermine.
Onewaywecanaddressthisissuetoisbetterexaminethethreedifferentorientationsavailablefor
thewristcuffinthemarket.Thiswillhelpusgetabetterinsightofwhichpositionscausegreater
marginsoferror,andhowtoadjusttothesensorsothatthesoftwaremaybemoreefficient.
Secondaryresearchofmarketeddevicewillalsoallowsustorectifytheshortcomingsandconcerns
oftheautocorrectingfeature.Validationtestingforthiswillalsoincludeusertestsandcomparison
torelatedmarketdevices.Bydetermininghoweffectivelyutilizethesensorwithoutcompromising
functionalityorincitinguserfrustration,wehopeourdevicewillbeabletoexcelinthemarket.
2.
DesignConcept
Thereviewalsorevealconcernsregardingthephysicalconceptofthedevice.Manyoftheconcerns
wereregardingthedetachablescreenoption.Reviewersquestionedthenecessityofsuchafeature.
Manydeviceofwristcuffsonthemarkethavescreensfixatedtothecuff,whichismeanttoallow
thedevicetobeusedindependently.Therewerealsosomesuggestionsforamoremoderndesign
ofthecuff,suchasusingawatchinsteadofthetraditionalbloodpressurestyle.Thesesuggestions
wastakeninconsideration,andanupdateddesigncanbeseenintheDesignChangessection.
3. DataStorage/Output
Therewerefewerconcernsregardingthisfocuspointofthereview.Usershadsomeconfusion
regardingthereadabilityofthescreenofthedevice.Therefore,thedesignoutputhastospecifythat
thescreencanbereadupto3feetaway.Inthisway,thedisplaywillbelargeenoughthattheuser
cancomfortablyreadtheirbloodpressurereadingswhenthedeviceisontheirwrist.Thisfeatureis
alsoaimedtoaccommodateforuserswhohaveproblemsrelatedtotheirvisionbyensuringthe
displaysizeislargeenough.Oneofthecommentsmadeonour4GBstoragewasifitwouldbe
enoughornot.Mostofthedatawillbetemporarilystoredforaccess,andwearehopefultohave
mostofittransferableviaBluetoothorexternaldevicestorage,forexampleaswithamicroSDcard,
orstorageonadifferentdevicealtogether.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page15
DesignChanges
Thedesigninputandoutputhavebeenupdatedinthefollowingways:
Thedevicewillbeawristcuffonly
Thescreenwillbefixedtothedevice
Thewillbemultiplesizeoptionstoaccommodateusers
A
dditions/ChangestoDesignInput
Thedevicewillfocussolelyontheissuesofthewristcuff.Previously,thedesignalsoincludedan
optionforanupperarmcuff,butasdiscrepanciesbetweenbloodpressurevaluestakenathomevs.
inthedoctorsofficeoccurmajorlyinwristcuffs,focuswasplacedentirelyonthistype.Thiswillalso
allowthedevicetocompetedirectlywithcommonpharmacybrandbloodpressurecuffswhilealso
addressingtheissuesofthosesamedevices.
AdditionstoDesignOutputs
Aftertakingintoconsiderationcommentsfromthedesignreview,thedeviceconceptwaschanged
toamodernstyled,hardshellcase.Thenewdesignmimicsbloodpressuremonitorsthatonemay
findinapharmacyfortheusertotesttheirbloodpressureinstore,wheretheuserplacestheir
wholearmthroughaplastictubeandaninternalcuffexpandsaroundthearmtotaketheblood
pressure.Thenewdesignwillbeasmallplastictubewithaninternalnyloncuffthatwillunhingefor
theusertoplacetheirwristinside,thenclaspbacktogether.Thiswillallowforeasierusewithone
hand,whichwasaconcern.Initiallythethecuffwillinflateitselftofitsecurelyaroundtheusers
wrist.Thentheuserwillpositiontheirarmandcaninitiatethecufftotaketheactualreading.The
cuffspressuresensorswilltakeintoconsiderthepressurethatwasneedtosecurethecuffontothe
wristwhentakingthereading.Thedevicewillbemanufacturedintwodifferentsizes,eachwitha
rangeofwristsizesthatitcanaccommodate.Theuserwillchoosewhichdevicewillfitthembetter.
Thescreenwillbefixeddirectlyintothedeviceforasimpleroveralldesign,whichwillalsoimprove
portability.Thewillbefourbatteriesinplaceinsteadofone,whichwillallowforacumulativeenergy
sourceof14.4V.Thesebatteriesarerechargeableandcanbereplacedifneeded.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page16
DesignOutput
DesignOutputSummary
BasedonourDesignconcepts,DesignInputs,andtheDesignReview,severalDesignOutputs
wereestablishedthatseemmostappropriateforthedevice.
Inclusionofsensorsinthecufftomonitorforcorrectpositioningofarmduringreading:Pressure
sensors,gyroscopes,accelerometers
Autocorrectionalgorithmincorporatedintosoftware
Cufftobemadeoutofnylonmaterialasthatisstandardtocuffsandwillprovideeasy
maintenanceandcomfort
Powersourcewillbearechargeableinternalbatterythattakesadvantageof120Vhousehold
outlets.Thesebatteriesshouldberechargeable,lightweight,andberelativelysmalltobe
encompassedintothedeviceeasily.
DatawillbestoredinInternalmemory,tobeaccessedondevice,anddownloadableviaUSBor
microport
Wireless/Bluetoothintegrationforquickdownloadofdatatoseparatedeviceorcomputer
Devicewillhavecodethatwillselfevaluatetodetectabnormalreadingsfromthepatient's
norm
Manysignificantfeaturesofthefunctioningofthedevicewillbeinternal,butchoicestothedevice
designcanbeseenintheDesignConceptOverview.
TableV:DesignConceptSummary
UserNeed
DesignInput
DesignOutput
Comfortable
Cuffmadeofsoft,flexible,and
breathablematerial
Nylon
Lightweight
Under450g
163.7g
Mobility
Smallsize
Wrist
Storage
Datashouldbestoredfor
use/analysis
InternalFlashMemory
Display
Displayshouldbereadable
fromupto3ftawayfromuser.
Screenattachedtodevice:LCD
touchscreen
PowerSupply
EnergyEfficient
Device/Batteryshouldlast1+
years
Rechargeablebatteries,Pluginfor
Energyto120V(Householdoutlet)
Beabletorecognizean
inaccuratereadingandinform
theuser
Gyroscopeandaccelerometer
sensorstodetectpositionofarm,
pressuresensors
Lastsatleast5,000uses
Mustautocorrecttodisplay
accuratereadingand/orbeable
torecognizeaninaccurate
reading
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page17
Figure4:
DrawingofDesignConcept
Thedesignwillfeatureaninflatablenyloncuffencasedinahighdensitypolyurethaneplasticshell.
Theshellwillfeatureahingeandamagneticclaspthatwillallowtheusertoopentheshelland
placetheirwristinside.Pressuresensorswilldetectwhenthecuffhasinflatedtotheappropriate
amountbasedonthesizeoftheuserswrist.Fromthere,thesensorwillzerooutandwillallowthe
bloodpressuretobetaken.Datawillbestoredwithinthedeviceusinginternalflashmemory.The
devicewillautocorrectreadingsbasedonthepositionoftheusersarmwithacombinationofa
gyroscope,pressuresensors,andanaccelerometer.Thedevicewillbepoweredbyrechargeable
batteriestheuserwillbeabletoplugtheirdeviceintoastandardoutlettocharge.Thedevicewillbe
relativelylightweighttoensurecomfortandconveniencefortheuser.Theuserwillinteractwiththe
deviceandresultswillbedisplayedonatouchscreendisplaybuiltintotheplasticshell.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page18
Autocorrection:SoftwareCode
Theautocorrectionfeaturewillrunbytwomethods:Gyroscopicmeasurementstodeterminecorrect
positioningandasoftwarecodetodetermineifthereadingiserroneous.Thepreliminaryalgorithm
ofthefunctioncanbeseeninFigure5.First,whentheclientpositionstheirarmtotakethereading,
thesoftwaredetermineswhetherthepositioningisarecognizedorientation.Ifincorrect,theuserwill
beinstructedtoreorienttheirarmandtryagain.Ifcorrect,thebloodpressurereadingwillbetaken.
Ifthisreadingissignificantofffromthebaselineorpreviousreading,thesoftwarewilltryto
determineiftheerrorwasduetotheusersarmpositioningorsoftwareerror.Thedevicemay
requiretheusertowaitandtakethereadingagain,otherwisethedevicewilldisplaythereading
recorded.Theautocorrectionofthebloodpressurereadingwasatopicoconcernduringthedesign
review,thereforethisaspectwillbefurtherreviewedinfutureplans.
Figure5:
DeviceAutocorrectionalgorithm
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page19
DesignVerification
TableVI:DesignConceptVerification
UserNeed
DesignInput
DesignOutput
17
Verification
Comfortable
Cuffmadeofsoft,
flexible,and
breathablematerial
Nylon6,6(Polyamide)
[1]
Mostcommonofcuffs
Ultralightweight
Dimensionalstability
Comfortable
PurchaseNylonCuff:$8.78[2]
Inexpensive
Thedeviceshould
costnomorethan
$125totheuser
Componentscostless
than$100topurchase
ofmanufacture
Display=$17.99[3]
Batteries=$11.80[4]
BoschGyroscope=$3.58[5]
Nyloncuff=$8.78[2]
InternalMemory:
$4.94[6]
PressureSensor:$44.33
Aircompressor:$11.55
TotalCost:$102.97
Lightweight
Under450g(Less
than1lb)
185.0g
Battery=25.6g[3]
Display=107g[2]
Memory/Gyroscope<1g
NylonCuff=27.2g[2]
InternalMemory=2.4g
Pressuresensor=0.5g
Total:163.7g
Storage
Datashouldbe
storedfor
use/analysis
InternalMemory
FlashMemory4Gb3V25nsNANDFlash
bySpansion
cost:$4.94[6]
Display
Displayshouldbe
readableupto3ft
awayfromuser.
Fixedscreen
4.3inch480x272TouchLCD
95.0453.86mm
Cost:$17.99
107g[3]
3Dprintedplasticcase
PowerSupply
EnergyEfficient
Device/Battery
shouldlast1+years
Rechargeablebattery,
PluginforEnergyto
120V(Household
outlet)
CoinCellBattery24.5mm
(RechargeableCR2450)
3.6V(each)for14.4V
weight6.4g
cost:$2.95each[4]
Lastsatleast5,000
uses
Mustautocorrectto
displayaccurate
readingand/orbe
abletorecognizean
inaccuratereading
Beabletorecognize Sensorstodetect
aninaccuratereading positionofarm
pressuresensors
andinformtheuser
gyroscope
accelerometer
BloodPressure
Functioning
Gyroscope(Model
BMG160byBosch)todetectincorrect
anglepositioning
$3.58[5]
BoardMountPressureSensors
10V
cost:
$44.33[6]
DC12VAircompressor
cost:$11.55[7]
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page20
AfterreviewingtheDesignInputsandDesignOutputs,specificcomponentsofthedesign
optionwerechosen.Theseareshownintheverificationmatrixabove.Theinternalcuffwillbemade
fromNylon6,6(Polyamide),chosenforitsresistancetowear,durability,lightweightattribute,low
maintenance,andcomfort.Thedeviceitselfwillalsobelightweightitwillbeatotalof162.2g,as
evaluatedabove.DatawillbestoredinternallyusingaFlashMemory4Gigabytechip
thatallows
forprogrammablememory.Thescreenis9.5cmby5.4cmtouchscreendisplay,andwillbe
encasedinacustomprintedplasticcase.Itwillbeabletoconnectdirectlytothecuff.Thedevice
willbepoweredby4coincelllithiumionrechargeablebatteriesforconvenientandreliablepower.
Thedevicewillautocorrectreadingsbymakinguseofasensorthatdetectsthepositioninthearm
throughtheuseofalowcostgyroscopesensor,specificallytheBMG160byBosch,thathasthe
smalldimensionsnecessarytofitinsidethewristcuff.ABoardMountPressuresensorswillbeuse
tobothcalculatedthedifferentialpressuretoreadthebloodpressure,andgaugepressurerelative
totheoutsidepressuretohelpwillcuffsecuring.
Thecustomplasticcasewillbemadeoflightweight,durableplastic.Asthiswasanew
designchange,detailedverificationwillbenecessaryforthis.Itexpectedthatalightweightandcost
effectivematerialwillbedeterminedthroughresearch.Thiswillinvolvedeterminewhichplasticsare
medicalgradetoensurethatthedesigncanmaintainanauthentic,medicalaesthetic.Oncethisis
select,thematerialpropertieswillthenbeappliedtoaCADmodeloftheshell.Iftheweightexceeds
thedesignconstraintsestablish,furtherrevisionswillbenecessary.
FuturePlans
Validation
Thesoftwarecodevalidationfortheproperfunctioningofthedevicewillbeanecessaryfirst
step.Thiswillinvolveprogrammingthecommunicationofthebloodpressurereading,display,
sensors,memory,andautocorrection.Aftertheassemblyofcomponents,thevalidationofthe
functionofthesoftwarewillbeoftoppriority.Aspreviouslymention,toaddresstheautocorrection
issuewewillplantoexaminethethreedifferentorientationsavailableforthewristcuffandlookat
marketexamples.Thiswillhelpusgetabetterinsightofthemarginsoferrorforthedifferent
positions,andhowtoadjusttothesensorandthesoftwaremaytoaccountforthese.Validation
testingforthiswillalsoincludeusertestsandcomparisontorelatedmarketdevices.Bydetermining
howeffectivelyutilizethesensorwithoutcompromisingfunctionalityorincitinguserfrustration,we
hopeourdevicewillbeabletoexcelinthemarket.
Aprototypeofthisdevicewouldbesharedwithphysiciansandcurrentusersofsimilar
devices.Feedbackonthedesignanddesigncomponentswouldberequestedfromthem.Anyvalid
feedbackphysiciansandusersofthedevicecontributewouldbeconsideredandpotentially
implementedinfutureversionsofthedesign.
BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page21
References
[1]"ContiFibre."
Nylon
.N.p.,n.d.<http://www.contifibre.com/eng/nylon>.
[2
]"AdcuffNylonCuffs."
ADC83011AN
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CAWELAID=120141310000056386&CAGPSPN=pla&gclid=CIOnx6XSwckCFRCGaQodfqUCX
w#.VmE7dPmfrRY>.
[3]
4.3inch480*272DOTSMulticolorGraphicLCD,withtouchscreen"
4.3inch480x272Touch
LCD(A)
.
WaveshareElectronics.,n.d..
<http://www.waveshare.com/product/modules/oledslcds/graphiclcd/4.3inch480x272touchlc
da.htm>.
[4]
"CoinCellBattery24.5mm(RechargeableCR2450)."SparkFun.com
PRT10319
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<https://www.sparkfun.com/products/10319>.
[5]
BMG160BoschSensortec.
MouserElectronics,n.d.page.Web.
<http://www.mouser.com/new/boschsensortec/boschsensortecbmg160sensor/>
[6]
BoardMountPressureSensors0to5PsiDiff.Gauge4PinSMT.
26PC05SMT.
Honeywell|
MouserElectronics
.N.p.,n.d.
<http://www.mouser.com/ProductDetail/Honeywell/26PC05SMT/?qs=pLJKYPamQJwQAoLAzy
fXiA%3D%3D>.
[
7]"DC12VAirPumpCompressorBloodPressureMonitorForElectronicMedicalDevicesFree
ShippinginBloodPressurefromHealth&BeautyonAliexpress.co."N.p.,n.d.
<http://www.aliexpress.com/item/DC12VairpumpcompressorBloodpressuremonitorForEle
ctronicMedicalDevicesFreeshipping/1935069353.html>