Sunteți pe pagina 1din 22

Team:Group4TIDE

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
Page1

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
Page2

TableofContents

Background......................................................................................

ProblemStatement........................................................

DesignInput......

UserNeeds...

DesignSpecifications......

DesignDevelopment....................................

DesignTools............

DesignReview.......................

13

DesignChanges......

15

DesignOutput.........

16

Verification..........

19

FuturePlans.......................................................................................

20

Validation............

20

References.......

21

BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page3

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
Page4

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
Page5

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
Page6

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
Page7

Figure2:
ConceptMapofIdeas

BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page8

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
Page9

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.

BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page10

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
Page11

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
Page12

pluggedintoawalloutlettocharge.Thedetachabledisplaywillbecustomizablesothepatientcan
viewthedatainawaymostconvenienttothem.

PreliminaryDesignSketches

Figure3:P
reliminaryDesignConcept

BME2910Group4DesignHistoryFile:AutocorrectingBloodPressureCuff
Page13

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
Page14

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
.N.p.,n.d.
<https://www.4mdmedical.com/index.php/catalog/product/view/id/26947/s/adcuffnyloncuffs/?
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
.N.p.,n.d.
<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>

S-ar putea să vă placă și