School of Engineering Science Simon Fraser...

March30,2017

Dr.AndrewRawiczSchoolofEngineeringScienceSimonFraserUniversityBurnaby,BritishColumbiaV5A1S6Re:ENSC440DesignSpecificationforCF(CysticFibrosis)ScannerDearDr.Rawicz,EnclosedisourDesignSpecificationforaCysticFibrosisScanner,proposedbyCFTRSolutions.CFTRSolutions’goalistodesignacysticfibrosisscannerthatwilldetectthechloridelevelthroughconductivitymeasurementsanalyzedfromsweatofpotentialvictims.Itreducescostandsimplifiesinstructionstoincreasetheavailabilityindevelopingcountries.ThepurposeofthisDesignSpecificationistooutlinethedesignconceptoftheCFScanner.Furthermore,itwillprovideanindepthanalysisofthesystemoverview,overalldevicerequirements,engineeringstandards,andthesustainabilityandsafetyissuesofourproduct.CFTRSolutionsisaninnovativemedicaltechnologycompanythatwillalwaysfocusonimprovingindividual’slifequalitywithpassionateanddetail-orientedmembersofBradleyDalrymple,JohnnyChou,ChristopherLe,TedLee,JaeMinSong,andWinstonYe.Pleasefeelfreetocontactusforfurtherquestionsorconcernsregardingtheproposal.Sincerely,

BradleyDalrympleCEOCFTRSolutions

CFTRSolutionsTeam:BradleyDalrympleJohnnyChouChristopherLeTaiTeLeeWinstonYeJaeMinSongContactPerson:[email protected]:Mr.SteveWhitmoreDr.AndrewRawiczSchoolofEngineeringScienceSimonFraserUniversitySubmissionDate:Mar30th,2017Version1.0

DesignSpecification

Abstract

CysticFibrosisisaterriblediseasethatisaffectingthelivesofmanyindividualsaroundtheworld.AccordingtotheCysticFibrosisFoundationwebsite,itisstatedthattherearemorethan70,000peopleworldwidethatarecurrentlybeingaffectedbythisdisease[1].Thenumberscanvarysincetestinginruralareasislimited.ThishereditarydiseaseisamutationoftheCFTRgene,whichcancausethelungstofillwithmucous[2].Inaddition,thisdiseasealsotargetsthe“pancreas,liver,intestines,sinuses,andsexorgans”[3].Withamortalityrateofabout2%[4],weshouldtreatCFpatientswiththemaximumamountofcare,asthereiscurrentlynocureforthisdisease.Whiletreatmentsexisttoimprovethequalityofcare,detectionisthepriority.Sincegenetictestingisexpensive,pre-screeningtestsaredonetoreducetheamountofapplicantsthatneedtobegeneticallytested.ThisdocumentwilloutlineCFTRSolutions’approachtheCFScanner;anaccurate,cost-efficientsolutionforpre-screeningcysticfibrosis.Thisproductwillreplacethesweattestindevelopingcountriesthatareunabletoaffordtheinfrastructureorproximitytomedicalprofessionalsandprovidebettersupporttoremotecommunitiesinmoredevelopedcountries.TheCFscannergivesresultsinrealtimebytestingthepropertiesofthesweat,suchastheNAcontent.Therefore,theCFScannereliminatestheneedtobuildtheinfrastructure;suchaslaboratoriesormedicaltechnicians.CFTRSolutionisacompanycomposedofsixengineerswhostrivetohelpadvancecysticfibrosisdetection.WiththecostoftheCFScannerbeingcheaperthanthetraditionalscreeningtestandresultsinrealtime,wecanbringthistechnologytodevelopingcountriestoimprovethequalityofcare.Weaimtonotonlyimprovethelivesaroundus,butaroundtheworld.

TableofContentsAbstract........................................................................................................................................................3

1.0Introduction...........................................................................................................................................6

1.1Background...................................................................................................................................6

1.2Scope............................................................................................................................................7

1.3IntendedAudience........................................................................................................................7

2.0SystemOverview...................................................................................................................................7

3.0HardwareDesign....................................................................................................................................9

3.1Arduino......................................................................................................................................10

3.2SweatSensor...............................................................................................................................11

3.2.1Sensor(PhaseOne)GroveGalvanicSkinResponse............................................................11

3.2.2Sensor(PhaseTwo):CustomCircuit....................................................................................12

3.3LCDScreen..................................................................................................................................13

3.4Speaker.......................................................................................................................................14

3.5FutureImplications.....................................................................................................................14

3.5.1Microcontroller...................................................................................................................14

3.5.2Sensor(PhaseThree):NaClSensor......................................................................................14

4.0SoftwareDesign...................................................................................................................................15

4.1Arduino.......................................................................................................................................15

4.2UserInterface.............................................................................................................................15

5.0SustainabilityandSafety......................................................................................................................16

6.0TestPlan...............................................................................................................................................17

6.1UnitTest......................................................................................................................................17

6.1.1Hardware.............................................................................................................................17

6.1.2Software..............................................................................................................................17

6.2RegressionTesting......................................................................................................................18

6.3SystemTesting............................................................................................................................18

7.0Conclusion............................................................................................................................................18

References.................................................................................................................................................19

AppendixA:TestPlans...............................................................................................................................21

AppendixB:UIDesign................................................................................................................................33

1.0Introduction.........................................................................................................................................33

2.0UserAnalysis........................................................................................................................................33

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3.0TechnicalAnalysis:..............................................................................................................................34

3.1Discoverability.............................................................................................................................34

3.2Feedback.....................................................................................................................................34

3.3Affordances.................................................................................................................................35

3.4Signifiers......................................................................................................................................35

3.5Mappings....................................................................................................................................35

3.6Constraints..................................................................................................................................35

3.7ConceptualModel.......................................................................................................................35

4.0EngineeringStandards:.......................................................................................................................36

4.1AnalyticalUsabilityTesting.........................................................................................................36

4.2EmpiricalUsabilityTesting..........................................................................................................37

4.3GraphicalPresentation...............................................................................................................38

5.0Conclusion............................................................................................................................................38

ReferencesforAppendixB:UIDesign.......................................................................................................39

ListofFiguresFigure1StateDiagramofourcurrentCFScanner......................................................................................8Figure2ComponentBreakdownsfortheCFScanner.................................................................................9Figure3ArduinoPeripherals.......................................................................................................................9Figure4GroveGSRwithElectrodes..........................................................................................................12Figure5SchematicoftheGSRGrove........................................................................................................12Figure6VoltageDividerwithHumanasZ1................................................................................................13Figure7HD44780ULCD,ArduinoCompatibleMonitor............................................................................13Figure8BlockDiagramofLCDfortheArduinoBoard...............................................................................13Figure9Mini8-OhmSpeakerfortheArduinoBoard................................................................................15Figure10SolidworksschematicfortheCFScanner..................................................................................38

ListofTablesTable1ActionandResultoftheStateDiagraminFigure1........................................................................8Table2SpecificationComparisonforArduinoUno,RaspberryPiandIntelEdison..................................11Table3PinNoandFunctionfortheHd44780LCDScreen........................................................................15Table4ProcedureDifferenceBetweenSweatTestandCFScanner.........................................................35

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1.0Introduction

1.1 BackgroundCysticfibrosis(CF)isafatalgeneticdiseaseaffectingchildrenandyoungadultsmainlyinthelungsandthedigestivesystem.CFiscausedbythepresenceofmutationsinbothcopiesofthegeneforthecysticfibrosistransmembraneconductanceregulator(CFTR)protein,whichisinvolvedintheproductionofsweat,digestivefluids,andmucus[2].ThemalfunctionoftheCFTRproteincausesthesecretionofmucustobecomethickerthannormalwhichcanleadtoseverelungconditions,suchascoughingandshortnessofbreath.[4]

Atthemoment,thereisnocureforCysticFibrosis.Theoutlookforpatientswiththediseasehasimprovedsteadilyovermanyyears,largelyasaresultofearlierdiagnosis.Therefore,earlydetectionisextremelyimportantinordertokeepthediseaseundercontrol.AsweattestandgenetictestingdiagnoseCysticFibrosis.ThesweattestisconsideredthegoldstandardforscreeningCFduetoitsdistinctsymptomoffivetimesthenormalamountofsodiumandchlorideinthepatient’ssweat.[2]

Unfortunately,researchhasshownthatthecurrentsweattesthasseveraldisadvantages,suchasitshighcostandinconsistentresultsduetohumanerror.Theaveragecostofperformingasweattestisaround$400inCanada[5].ThedrawbacksofthecurrentsweattestledtothedevelopmentoftheSweatScannerthatwearedesigningforthisproject.TheSweatScannerisareliable,costeffective,andfastscreeningtechnologyforCFwhichmodifiestheexistingsweattesttechnologytoincreasetheaccessibilityofthetestbyremovingthenecessityofmedicalprofessionalstoperformCFscreening.

TheSweatScanner,developedbyCFTRSolutions,hastwomajorobjectives.Firstly,tocreateauser-friendlymedicaldevicewhichoperatesinrealtimethatcanbeusedtodetecttheamountofsodiumandchloridethatexistswithinapatient’ssweatinanon-invasivemanner.TheothergoalistoprovideanaffordableandreliablescreeningtestforCFinthirdworldcountries.Theproductwillbecarefullydesignedinsuchawaythatitwillbeeasytousebyanyindividual,andwillbeabletoprovideconsistentandaccuratemeasurementsofsodiumandchloridecontenttoprovideareliabletestingresult.Withthetechnology,CFTRsolutionsbelievethatwecanhelptofightcysticfibrosis.

AccordingtotheCysticFibrosisFoundationPatientRegistry,therearecurrentlyapproximately30,000peoplelivingwithCFintheUnitedStatesandmorethan80,000worldwide.[6]Statisticsalsorevealthatapproximately1,000newcasesofCFarediagnosedinthecountryeachyear.However,thediagnosisofthediseaseisstilloftendelayedormistakenlyconducted.Basedonthestatistics,therateofmisdiagnosisofCFisaboutfourpercentwhenpre-screeningwiththeexistingsweattest.[6]

CFisthemostcommonlethalgeneticdiseaseandwasfirstidentifiedbyDr.DorothyAndersonin1938.Inthe1950s,themedianlifeexpectancyforpatientswithCFwasjustafewmonths.Themedianageofsurvivalhasincreasedsteadilyoverthepast60yearsandisnowmorethan40yearsoldindevelopedcountries.[4]

7Figure1:IllustrationofthePrototypeofCFScanner[6]

TheoverallqualityoflifeandlifeexpectancyofCFpatientshasimprovedsignificantlyoverthepasttwodecades,largelyasaresultofearlierdiagnosis,moreadvancedtherapy,andprovisionofcare[7].Researchhasshownthatnewbornscreeningreducesthediseaseseverityaswellastheburdenandfinancialhardshipsofcare.ThediagnosisofCFisusuallydonebyascreeningsweattestfollowedbygenetictestingifthescreeningresultispositive.ThesweattestremainsthemostcommonandaccessiblewayofscreeningforCFoffered,asCFhasadistinctcharacteristicoffivetimesthenormalamountofsodiumandchlorideinthepatient’ssweat.[6]Thesweattestisdonebyapplyingpilocarpineontothepersonbeingtestedtoinducesweatingandsweatiscollectedfor30minutes.Severallaboratorymethodsarethenusedtodeterminethesodiumandchlorideconcentrationsinthesweatquantitatively.[7]

1.2 ScopeThisdocumentoutlinesalltheimportantdesignspecificationsfortheCFScanner,andtherelevanthealth,safety,andUIspecificationofourproduct.Thefollowingsectionswilldetailhowwehaveandwillcontinuetodesignanddevelopourhardwaresensors,software,andfirmwareoverthenextfourmonths.

1.3 IntendedAudienceThisdocumentistobeusedbyCFTRSolutionsmemberstoaidthemindesignprocess,aswellasthedevelopmentofbothelectronicandsoftwarecomponentsoftheCFScanner.Testplansareincludedinthisdocumentastheprototypetransitionsbetweenstages,andaregressiontestwillberun.Asystemtestaswellasausertestisalsoincludedtoallowforadetailedqualityassuranceprocesstobecompletedonourproduct.

2.0SystemOverview

TheCFscannerteststhesaltcontentonthepatient’sskin,whichcanincreaseinsaltcontentbytwotofivetimesiftheCFTRgeneismutated.BelowisthestatediagramforourCFScanner.WehavechosenthemethodbelowtocloselymatchtheexistingtestbutallowforrealtimeresultstoimprovethequalityoflifeforCFpatientsglobally.

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Figure1StateDiagramofourcurrentCFScanner

Table1.ActionandResultoftheStateDiagraminFigure1

Phase Action Result

CleanSkin Cleantheskinwithwithwatertoremoveanychemicalsthatmaybeontheskin

Thiswillensurethatthereisnocontaminantinthesweat

ApplyPilocarpine

Applythischemicaltotheskin Thischemicalisdesignedtoinduceacontrolledsweatintheexistingsweattest

ApplyElectrodes

Adda0.4mAcurrenttothepatientthroughthePilocarpineappliedabove

Sweatingwillbeinducedatthisstepandwaitfiveminutes

Cleanskin Cleantheskinwithwithwatertoremoveanychemicalsthatmaybeontheskinsuchasthechemicalappliedabove

ControlledsweatingwillleaveathinlayerofionizedNAionsfromthesweatthatwewillmeasure

ApplySensor Measurethesaltcontentinthesweat Determineiftheamountofsaltiswithin

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therangeofCFpatients

Viewresults Inrealtimeseetheresultsofthetest Improveonthequalityoflifeforpatientswhodon'thaveaccesstolabs

InTable1,wehaveusedacombinationofhardwareandsoftwaredesignsthatyoucanseebelowinsection3and4.Additionally,wehaveaddedatestingtoolthatallowsustotestourproduct,askinphantom.Askinphantomisachemicalrecreationofrealskinthatwillmimicthechemicalpropertiesofdifferentsweatcontentsontheskin.Wechosetousethistechnologytotestabaselinetoensurethatourreadingsaccountfortheexactchemicalmakeupbeforeaccountingfordifferentimpurities.Below,wewilldetailthetechnologieswewillcreateandusetodesigntheCFScanner.

3.0HardwareDesign

TheCFScannerusesacombinationofhardwareandsoftwarecomponentsinitsimplementation.ThehardwarebreakdownofourdesigncanbefoundbelowinFigure2.Therearetwousersoutsideofthedesign,theuserandthepatient,butwehopetoimproveourdesigntomakeiteasyenoughtousesothatthepatientswillhavetheabilitytoself-diagnosebyrunningthetestonthemselves.

Figure2ComponentBreakdownsfortheCFScanner

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3.1ArduinoPriortodecidingtheuseofArduinoUnoforourproject,wecomparedothercompetitorssuchasRaspberryPiandIntelEdison.Thefollowingtablelistssomeofthekeyfeaturestohelpusdeterminethesuitabilityofeachoption.

Table2.SpecificationComparisonforArduinoUno,RaspberryPiandIntelEdison

Categories ArduinoUno RaspberryPi IntelEdison

Price $25 $35 $75

Size 7.5x1.9x6.4cm 8.5x5.6x1.7cm 3.5x2.5x0.39cm

Memory 0.002MB 512MB 1GB

OnboardNetwork None 10/100EthernetsocketDual-band(2.4&5GHz)

Wifi,BT4.0

Inputvoltage 5,7-12V 5V 3.3-4.5V

FlashMemory 32KB MicroSDCard 4GBeMMC

OperatingSystem None Linux YoctoLinuxv1.6

IntegratedDevelopmentEnviornment(IDE) ArduinoIDE

Scratch,IDLE,anythingwithLinux

ArduinoIDE,Eclipse,IntelXDK

SoC ATmega328P BCM2836 IntelAtomZ34xx

CostofSoC $2.50 N/A N/A

Table2mostnoticeablefeatureisthepricedifference,whereArduinoissubstantiallycheaperthanIntelEdison,andslightlymoreexpensivethanRaspberryPi.Additionally,PiandEdisonbothhaveanonboardnetwork,whileUnodoesnot.ThemostimportantaspecttonoteistheabsenceofanOSinUno.Theinputvoltageshouldbenotedaswell,asitaffectsthebatterylife.

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Ultimately,wedecidedtogowithArduinoUnoforseveralreasons.Firstly,wedonotneedafullOSasourproducthasveryspecifictasksandwillnotneedadditionalprocessing.Secondly,purchasingtheSoCforUnoispossibleatonly$2.50,whereastheotherSoCoptionscannotbepurchasedinabulkamount.Sinceweareonlyatourprototypephasewhereweareusingoff-the-shelfproducts,itisalsoimportanttokeepinmindforourfutureproductionwherewewillbecreatingcustomPCB.Thiswillallowustohaveauniqueproductspecifictoourusage,andhelpcutdownthecostsofremovingcomponentsnotbeingused.Also,theprogramminginArduinoIDEintheprototypeallowsoursoftwaretoeasilytransferoverinthesameenvironmentusingATmega328P.

3.2SweatSensorWewillbegoingthroughseveralsweatsensorprototypestoestablishwhatwillprovidethebestvaluestobeusedforourmedicaldevice.Wewillbegoingthroughpurchasingoff-the-shelftocreatingacustomGSRsensor,andpotentiallycreatingasensorthatonlydetectssodiumchloride(NaCl).

3.2.1Sensor(PhaseOne)GroveGalvanicSkinResponseAnincreaseinsaltwillincreasethecurrentflow.TheGSR,alsoknownasSkinConductanceResponse(SCR)ormorecommonlyElectro-dermalActivity(EDA),passesaweakcurrentthroughtheskinandmeasureschangesinelectricityflow.

Forourfirstprototype,wepurchasedanoff-the-shelfGroveGSRSensor(Figure4),whichisasimplecircuitthatcanbebrokendownintofourseparateparts.

1. TwoelectrodesconnectedtoVccwith200Kohmsandground(tobeplacedontheforearm)2. Twounitygainamplifier,oneforthepowersignal,andtheotherfromtheelectrode3. Differentialamplifierwithalowpassfilter(RC)4. OutputSignal

Figure4GroveGSRwithElectrodes

Figure3ArduinoPeripherals[8]

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Figure5SchematicoftheGSRGrove[9]

Usingauniversal4-pinconnector,weconnectSIG,VCCandGNDtoArduinoUno.TheSIGmustbeconnectedtoanyAnalogInpinsthatgoesthroughanADC.UsingtheanalogRead()command,itwillthenmaptheinputvoltagesrangingfrom0to5V[3.2.1-P3-II]intointegervalues0to1023(max5V).

3.2.2Sensor(PhaseTwo):CustomCircuitAftertestingaGSRandobtainingseveralvalues,weconcludeditwouldbebeneficialtocreateourowncustomcircuit.AsyoucanseeinFigure5,thedifferentialamplifierfromtheoff-the-shelfsensorcurrentlycomparesthechangeinvoltagetoaconstantvalue.Instead,wewouldliketomeasuretheconductancedirectlyandasimplermethodcanbeused.ByusingthevoltagedividerinFigure6,wecansetVinandR2,andbymeasuringVout,,R1canbefoundthroughthefollowingFormulas,

(1) (2)

Figure6VoltageDividerwithHumanasZ1

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Wecameupwiththismethodafterhavinginconsistentvaluereadingsfromourphantomskin,eventhoughwewereabletoobtainreadingsonhumanskin.Sincethisisaresearch-basedproject,furthertestingwillbedonetodeterminewhichsensortouse,oranintegrationofboth.

3.3LCDScreen

Figure7HD44780ULCD,ArduinoCompatibleMonitor

TheLCDscreenwilldisplaytheresultsfromoursensorindicatingwhetherthepatientisclearofCForwillrequireadditionaltesting.Also,whenthereispoorcontactpoint,ourLCDwillnotifytheuserbydisplayingtext“BETTERCONNECTIONREQUIRED”[3.1.1-P2-III].FromthedatasheetofourLCDmodule,theblockdiagramisincludedinFigure8.

Figure8BlockDiagramofLCDfortheArduinoBoard

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WechosethisLCDbecauseitincludesthecommonHitachi’sHD44780Uliquidcrystaldisplaycontroller,whichArduinoprovidesastandardLibraryfor(LiquidCrystal).Therewillbeatotalof16pins,butweonlyneedatotalof6tocommunicatewithLCDforourcurrentprototype;RS,EN,andD4-D7highlightedinredfontinthetable.WecanconnectD0-D3aswell,buttheonlybenefitwewillreceiveisthespeed,whichwedonotrequire.Additionally,apotentiometercanbeaddedtoadjustthecontrastofthescreen[3.2.2-P2-II].

Table3.PinNoandFunctionfortheHd44780LCDScreen

PinNo. Function PinNo. Function PinNo. Function PinNo. Function

1 VSSGND 5 R/W 9 DB2 13 DB6

2 VDD5V 6 EN 10 DB3 14 DB7

3 Contrast 7 DB0 11 DB4 15 LED5V

4 RS 8 DB1 12 DB5 16 LEDGND

3.4SpeakerAsper[3.2.2-P3-II],thespeakermustoutputaudiofrequencybetween300-3400Hzinorderforustoplaypre-recordedmessagessuchasinstructionsorwarnings.

3.5FutureImplications

3.5.1MicrocontrollerAsmentionedin3.1,wepickedArduinoUnowiththefutureproductinmind.WiththeeasilyaccessibleATmega328P,wecancustomizeourboarddesigntoourspecificneeds.AllthecomponentssuchasMCU,LCD,sensorsandspeakerscanbeononephysicalboard,ratherthanhavingwiresgoingacrossseveraldifferentpins.Thisisalsobeneficialwhenwearedesigningacasethatcansynergizewith,thatcaneasilybeaccessiblefordebuggingofhardware.

3.5.2Sensor(PhaseThree):NaClSensorForourfinalsensoriteration,wewillcreateasensorthatdetectstheNAioninsweat.Ourpastsensorshavebeenabletodetectandthereforedetermineconcentrationsbasedontheconductivityoftheion.Withtheincreaseinsaltcontent,thereisadecreaseinresistance,butthisishowevernottheonlyfactorinconductivity.WewillbedevelopingthissensoroverthenextfourmonthsinadditiontothemicrocontrollerandUImentionedaboveandbelowinsection4.Therearecurrentsensorsthathavethisabilityandasourdesignchangeswewillupdatethislivingdocumenttoreflectourmostcurrent

Figure9Mini8-OhmSpeakerfortheArduinoBoard

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circuit.Atthispointthisisaconceptdesignandwewillcontinuetouseourexistingcircuitandsensors.ThisnewsensorwilladdtoourexistingsensorsinimprovinguponourdetectionalgorithmandreducetheriskofmisdiagnosiswiththeCFscanner.

4.0SoftwareDesign

4.1ArduinoTobuildourproofofconceptforourposterpresentation,Arduinohasbeenchosenduetoitsabilitytoallowuserstodolow-levelprogramming.ArduinoIntegratedDevelopmentEnvironmentprimarilysupportsC/C++functionsthatcanbeusedwithoutanylibraries.SinceweneededdetailedmanipulationandcontrolofourGSRsensor,Arduinowasmoresuitableforourproject.Moreover,duetothenatureofthelearningprocessinSFUEngineering,ourgroupmembersweremorecomfortableworkingwithaprogramminglanguagetheyarefamiliarwith.

ByconnectingtheGSRsensortoanArduinoboard,wewereabletouseabuiltfunction“analogRead()”whichisa10-bitanalogtodigitalconverter(ADC).Thefunctionreadsintegervaluesdirectlyfromthesensorthatiswithintherangeof0to1023.Forthefurthercalculationoffindingelectricalconductance,thisrawdatamustbeconvertedintovoltagewithintherangeof0to5,whichcanbedonebymultiplyinganddividingtheobtainedrawdataby5and1023respectively.Fromthispoint,itispossibletotestanddeterminewhichsweatsolutionhasmoresodiumchloridecontentinit.Themoresodiumchloridethesweatsolutioncontains,themoreconductiveitwillget.Consequently,solutionswithhigherdensityofsodiumchloridewillproduceasmallerintegervalueofrawGSRdatathatindicatesadecreaseinvoltageandresistanceandincreaseinconductance.Thecalculatedconductancewillcontinuouslybeobtainedandstoredtokeeptrackofthetestprogress.Thedisplayedvalueswillthenbecomparedtoathresholdvalue,andifthevaluesmatch,thesystemwillinformtheuserontheserialmonitorwithawarningorsignal[10].

4.2UserInterfaceBeforewestartwiththeUItesting,wewouldfirstneedtoestablishasystemwithinourprototypewhereaLCDcandisplaysimplelettersandnumbers.Todoso,wecanimplementtheArduinoLCDlibrarywithinourcode.Forourprototype,weonlyrequiresimplecharactersfromtheASCIItabletobeabletodisplayontotheLCDscreen.ATutorialcanbefoundinthefollowinglink[https://www.arduino.cc/en/Reference/LiquidCrystal].Forconvenience,thisinformationcanalsobedisplayedonaCLIifthehardwarecomponentsareattachedtoaCPU,butforourPoC,wewanttodisplayaworkingprototype.TheimplementationoftheUIfortheCFScannerwillbegininthefinalstageofthesecondprototype.WewillbeprogramingtheabovementionedLCDscreenandallowtheusertomovethroughdifferentstatesoftheprocesswithdifferentbuttonstoallowthemtonotifytheCFscannerifeachprocesshasbeencompletedornot.Pre-loadingseveralcreatedimagestohelptheuserunderstandtheprocessthattheywillneedtoundertaketocompleteonetestwillcreatethis.

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5.0SustainabilityandSafety

ThegoalhereatCFTRsolutionsistonotonlyhelpcreateaproductthatcanhelpimprovethelivesofpatientsaffectedbyCF,butalsoconstructaproductthatissustainableandsafefortheuser.Inorderforustoachieveourgoal,weincludedthecradle-to-cradlemethodologyineverysinglestepwhenselectingourmaterial[11].Although,notallcomponentswithinourproductarerecyclable,wetriedtominimizethenegativeimpactthatitwillhaveontheenvironment.Withtherisingpopularityof3DPrinting,ourCFScanner’senclosureismadeentirelyofpolylactide(PLA)material.Thisisabiodegradablethermoplasticthatisderivedfromrenewableresourcessuchascornstarch,anditcanberecycledandcomposted.ThepowersupplyforourproductusesaLithiumIonRechargeableBatterythatcanbechargedanddischargedfor500cycles[12].AlthoughthesebatteriesarenotfullycertifiedbytheC-2-Cmethodology,amajorityofthecomponentscanberecycled.Duetotheabsenceoforganiccarbonbatteries[13]wehavechosenthisroute,astherearenootherfeasiblealternatives.Themicro-controllerandmedicalelectrodescanbesenttometalrecyclingfacilitiesoncetheirlifespaniscomplete[14],theycanalsoberepurposedandreusedforfutureprojects.CFScanner’sgoalistoadvancecysticfibrosisdetection;therefore,safetyisacrucialaspectwithinourcompany.AlltestingandassembliesareperformedundertheregulationsprovidedbytheMedicalDeviceRegulationsofCanada[15].Sinceourproductinducesasmallcurrentintotheskin,ourdeviceconsistsofasafetycut-offthatlimitsthecurrent,thusneverexceeding5mA[16].Todoso,wehaveimplementedaprogramthatturnsthedeviceoffonceitdetectsacurrentof5mAorgreater.Allacquiredchemicalsarefromwell-knownmanufacturersandreviewsoftheproductarethoroughlyexaminedbeforepurchasing.Theenclosureofthedevicewillcontainnosharpedges,andallCFTRsolutionsteammembersshallwearinsulatedglovesandbeattachedtoanantistaticwristbandwhentestingtopreventelectricalshock.ThisistohelpensurethesafetyofeachandeveryCFTRemployee.TheCFScannerisdesignedwithcomponentsthatabidebytheCAN/CSAStandardC22.2No.61010-1-12[17].ItalsocontainsLithiumIonBatteriesthatabidebyIEEEStandard1625forrechargeablebatteries[18].AllelectricalcircuitsfollowtheIECstandard60950-1andamendmentsA1andA2forthesafetyofinformationtechnologyequipment[19].Wehopethatbyfollowingthesestandards,willhelppromoteahazardfreeworkingenvironmentaswellastohelpprolongthelifespanofthefinalproduct.

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6.0TestPlan

6.1UnitTestToensurethequalityofourfinalproduct,theteamatCFTRhasdevelopedaseriesoftestingtechniquestohelpverifyitsfunctionalities.Thetestplanisseparatedintotwomaincomponents:hardwareandsoftware.Thefollowingsectionwilldetailtheproceduresnecessaryforeachpart.

6.1.1HardwareThemainfocusofourhardwaretestplanistoconfirmthattheoutputofeachofourmajorcomponentistobeworkingasdesigned.Sinceourproductreliesheavilyonthecorrectmeasurementofsalt(NaCl)content,emphasiswillbeputintothetestingoftheGSRsensors,asitistheonlymethodwithinourproductthatwillbemeasuringelectricalconductanceoftheskin.Verificationofothersensorswillalsobeconductedthroughoutaseriesofunittesting.Awhite-boxtestingtechniquecanbeappliedtothefollowingtestcases[20].

Testingproceduresforindividualcomponents:

1. GSRsensorsuccessfullymeasuresconductivityandcanbedisplayedontotheLCDscreen

2. CustomizedDMMcansuccessfullymeasureresistanceonphantomskin3. LCDscreenisabletodisplayletters,futureimplementationwillincludepictures4. Specificactionsactivatesuponsuccessfulpushofbutton5. Speakershouldproduceclearsoundswithminimalnoise6. LEDshouldlightupwhenthemachineison7. Batterycanbesuccessfullychargedthroughanoutlet/powersource

6.1.2SoftwareAcustommadePCBboardwillbeimplementedinourfinalproduct,butasofnow,wewillbeprogrammingmainlyinC/C++duetotheprototypebeinganArduinoUNOR3board.TheconceptfortheCFScanneristobeusedanywhereintheworld,hencethesimplicityandstraightforwardnessofourGUI.Eachfeaturewillbetestedindividuallypriortobeingassembledasawhole.

TestingProceduresforIndividualComponents:

1. TheArduinocandetecttheGSRsensorsuccessfully,andtheprogramwecreateinCcanrunanddisplayresultsonthecomputer

2. TheArduinocansuccessfullydetecttheLCDScreen.Textandnumbercanbeviewedonthescreen.

3. TheArduinocansuccessfullydetectthespeaker.Thespeakershouldbeabletoplayaseriesofsounds.

4. Testingofouralgorithm,sothatoncetheconductivitymeasuredfromthesensorsexceedsacertainvalue,immediateinstructionswillbedisplayedontheLCDscreen

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PleaserefertoAppendixAforourTestCaseEvaluationSheets.

6.2RegressionTestingAswemoveforwardfromPrototype-ItoPrototype-II,newcomponentswillbeimplemented,includingacustomizedPCBboardaswellasacustomizedGSRsensor.OurHardwaregroupwillbeworkingcloselywithProf.ParameswaranfromSimonFraserUniversityashespecializesinthefieldofelectronics.Withineachnewbuild,aregressiontestwillberantoensurethatoldbugsdonotreoccur,andthatthenewcomponentsareworkinginthenewiteration.

6.3SystemTestingBeforewefinalizeonourproduct,acompletesystemtestwillberan.Thiscrucialprocesshelpsdeterminetoensureourfullyintegratedsoftwareproductmeetstheend-userrequirements.Unlikethewhite-boxtestingtechniqueweusedinthehardwaresectionabove,thisisablack-boxtestingtechnique,wheretestersdonotneedtoknowtheinternalstructureoftheproduct[20].Asaresult,theymustbasetheirtestingsolelyontheuser’spointofview.

7.0Conclusion

ThedesignspecificationwillbeusedtoproducetheCFScanner.Thisdocumenthasbeendividedintothreemajorsections:systemoverview,software,andhardwaretoachievethemilestonesoftheprojectinamoreefficientmanner.Auserinterfacewillcontinuetobedevelopedtoimprovetheuserexperienceandallowanon-technicalpeopletooperatethisdevice,asthesweattesthasnopotentialrisk.Finalizingandproducingthedevicebyfollowingourtestingguidelinesfortheuser,remissionandsystemtestingwillincreaseourproductdevelopmentaswecontinuetobuildourprototypeoverthenextfourmonths.Wewillimproveourriskmanagementbydevelopingthedifferentphasesofoursensorsandimproveoursolution.WehopetocreateaproductthathasthepotentialtobedevelopedasweimproveuponthefoundationsofCFTRSolutions.

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References

[1]"AboutCysticFibrosis|CFFoundation",Cff.org,2017.[Online].Available:https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/.[Accessed:25-Mar-2017].

[2]"Cysticfibrosistransmembraneconductanceregulator",En.wikipedia.org,2017.[Online].Available:https://en.wikipedia.org/wiki/Cystic_fibrosis_transmembrane_conductance_regulator.[Accessed:28-Jan-2017].

[3]"WhatIsCysticFibrosis?-NHLBI,NIH",Nhlbi.nih.gov,2017.[Online].Available:https://www.nhlbi.nih.gov/health/health-topics/topics/cf.[Accessed:29-Jan-2017].

[4]"Cysticfibrosis-ERS",Erswhitebook.org,2017.[Online].Available:http://www.erswhitebook.org/chapters/cystic-fibrosis/.[Accessed:27-Jan-2017].

[5]“IndiaCDSCOMedicalDeviceRegistrationandApproval,”Emergo[Online].Available:https://www.emergogroup.com/services/india/india-medical-device-registration.[Accessed:20-Feb-2017].

[6]B.P.O'sullivanandS.D.Freedman,“Cysticfibrosis,”TheLancet,vol.373,no.9678,pp.1891–1904,2009.

[7]J.S.Elborn,“Cysticfibrosis,”TheLancet,vol.388,no.10059,pp.2519–2531,2016.[6]M.Miladi,"GrabCAD-CADlibrary",Grabcad.com,2017.[Online].Available:https://grabcad.com/library/arduino-uno-13.[Accessed:14-Feb-2017].

[8]"Bouni/Arduino-PinoutonGitHub",Libraries.io,2017.[Online].Available:https://libraries.io/github/Bouni/Arduino-Pinout.[Accessed:23-Mar-2017].

[9]A.Industries,"StandardLCD20x4+extras[whiteonblue]ID:198-$17.95:AdafruitIndustries,Unique&funDIYelectronicsandkits",Adafruit.com,2017.[Online].Available:https://www.adafruit.com/products/198.[Accessed:23-Mar-2017].[10]"Arduino-ReadAnalogVoltage",Arduino.cc,2017.[Online].Available:https://www.arduino.cc/en/Tutorial/ReadAnalogVoltage.[Accessed:30-Mar-2017].

[11]"Cradle-to-cradledesign,"inWikipedia,WikimediaFoundation,2017.[Online].Available:https://en.wikipedia.org/wiki/Cradle-to-cradle_design.Accessed:Feb.20,2017.[12]I.Buchmann,"Charginglithium-ionbatteries,"2017.[Online].Available:http://batteryuniversity.com/learn/article/charging_lithium_ion_batteries.Accessed:Feb.20,2017.[13]2017,"Thelithiumbatteryrecyclingchallenge,"2011.[Online].Available:https://waste-management-world.com/a/1-the-lithium-battery-recycling-challenge.Accessed:Feb.20,2017.[14]S.American,"Theenvironmentalimpactofcorn-basedplastics,"ScientificAmerican,2017.[Online].

20

Available:https://www.scientificamerican.com/article/environmental-impact-of-corn-based-plastics/.Accessed:Feb.20,2017.[15]"PCBrecycling-disposalofscrapprintedcircuitboards,".[Online].Available:http://www.webuyics.com/scrap-pcb.htm.Accessed:Feb.20,2017.[16]L.S.Branch,"Medicaldevicesregulations,"2016.[Online].Available:http://laws-lois.justice.gc.ca/eng/regulations[17]A.Sayed,"Howtoincreasethecurrentfrom100mAto450mAwithoutalteringthevoltage,"1971.[Online].Available:https://www.quora.com/How-can-I-increase-the-current-from-100mA-to-450mA-without-altering-the-voltage.Accessed:Feb.20,2017.[18]C.Group,"CAN/CSA-C22.2NO.61010-1-12(R2017),"ShopCSA,2015.[Online].Available:http://shop.csa.ca/en/canada/measurement-control-and-signaling-apparatus/cancsa-c222-no-61010-1-12/invt/27020962012.Accessed:Feb.20,2017. [19]I.-S.C.Policy,"IEEESA-1625-2008-IEEEstandardforrechargeablebatteriesformulti-cellmobilecomputingdevices,"2009.[Online].Available:https://standards.ieee.org/findstds/standard/1625-2008.html.Accessed:Feb.20,2017. [20]"DifferencesBetweenBlackBoxTestingandWhiteBoxTesting–SoftwareTestingFundamentals",Softwaretestingfundamentals.com,2017.[Online].Available:http://softwaretestingfundamentals.com/differences-between-black-box-testing-and-white-box-testing/.[Accessed:22-Mar-2017].[21]B.Dalrymple,W.Ye,J.Chou,J.Song,T.LeeandC.Le,"CFTRSolutionsFunctionalSpecification",2017.

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AppendixA:TestPlansA.1HardwareTestPlans

EvaluationSheetTesterID: Department: PhoneNumber: TestDate:

PreparedBy: Date: VerifiedBy: Date:

Results(PleaseSelectoneofthefollowingBoxes)

Approved

ConditionallyApproved

Disapproved

NotApplicable

ObservationsandAdditionalComments:

TesterName:(PleasePrint)

Signature: Date:

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HardwareTestCase1:GSRSensorsuccessfullymeasuresconductivityandcanbedisplayedontotheLCDScreen.Method of Testing:

The Tester will attach the Electrodes on some form of skin, whether it be human skin, pig skin, or phantom skin. Prior to the attachment of the electrodes, the surface of the skin must contain sweat content. Turn the machine on.

Criteria for Passing:

In order for this test to pass, the LCD screen must display the Conductivity Level of the skin that is being tested on.

TestSummary

MeasuresConductivity DisplaysonLCDScreen

Results: Approve Disapprove


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HardwareTestCase2:LCDScreenisabletodisplayletters.Futureimplementationwillincludepictures.Method of Testing:

The Tester will send a command onto the Arduino where Texts and Numbers should be displayed onto the attached LCD Screen. A Tutorial of how this works can be found in the following link: https://www.arduino.cc/en/Tutorial/TFTDisplayText


In order for this test case to pass, the LCD screen must display both Texts and Numbers.

TestSummary

LCDdisplaysTexts&Numbers LCDdisplaysPictures



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HardwareTestCase3:SpecificactionsactivatesuponsuccessfulpushofaButtonMethod of Testing:

Press the Button and check to see if it goes to the next set of instructions as well as giving a notification sound to confirm that the button has been pressed.


In order for this test to pass, the LCD screen must iterate through the instruction steps whenever the button is pressed and a Beeping sound should be heard.

TestSummary

NoiseProduced InstructionsBeingDisplayedonLCDScreen



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HardwareTestCase4:Speakershouldproduceclearsoundswithminimalnoise.Method of Testing:

Send a command to the Speaker through the computer and examine the noise that it produces


In order for this test to pass, the Speaker must be able to produce audible sounds in English and in notification noises such as a Beep

TestSummary

SpeakercanproduceaBeepingSound SpeakercanproduceaEnglishspeakingnarrator



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HardwareTestCase5:LEDshouldlightupwhenthemachineison,andturnsoffwhenthemachineisoffMethod of Testing:

Turn the machine on, and then turn the machine off.


In order for this test case to pass, the LED light should be turned on when the machine is on and off when it is off.

TestSummary

LEDON LEDOFF



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HardwareTestCase6:Batterycanbesuccessfullychargedthroughanoutlet/powersourceMethod of Testing:

Plug the battery to a wall plug and observe the battery icon. Do the same thing to a external power source.


In order for this test case to pass, the battery icon must show signs of charging.

TestSummary

Plugdevicetoawalloutlet Plugdevicetoaexternalpowersource



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A.2SoftwareTestPlans

EvaluationSheetTesterID: Department: PhoneNumber: TestDate:

PreparedBy: Date: VerifiedBy: Date:

Results(PleaseSelectoneofthefollowingBoxes)

Approved

ConditionallyApproved

Disapproved

NotApplicable


TesterName:(PleasePrint)

Signature: Date:

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SoftwareTestCase1:TheArduinocandetecttheGSRsensorsuccessfully,andtheprogramwecreateinC++canrunanddisplayresultsonthecomputerMethod of Testing:

The tester will run the demo code that will check and ensure the USB connection between the Arduino board and the computer. If the connection is successfully established, the system will start to display conductivity values on the computer monitor


In order for this test to pass, the demo code needs to be successfully run and displays test values.

TestSummary

Democodesuccessfullycompiledandrun Displaystestvaluesonthecomputer



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SoftwareTestCase2:TheArduinocansuccessfullydetecttheLCDScreen.Textandnumbercanbeviewedonthescreen.Method of Testing:

The tester will run the demo code that will check and ensure the availability to establish a connection between the Arduino board and the LCD screen. If the connection is successful and they can communicate with each other, the system will notify the tester.


In order for this test to pass, the demo code needs to be successfully run and the tester needs to be notified by the system.

TestSummary

Democodesuccessfullyrun Testernotified



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SoftwareTestCase3:TheArduinocansuccessfullydetectthespeaker.Thespeakershouldbeabletoplyaseriesofsounds.Method of Testing:

The tester will run the demo code that will check and ensure the availability to establish a connection between the Arduino board and the speaker. If the connection is successful and they can communicate with each other, the system will notify the tester and play sound samples.


In order for this test to pass, the demo code needs to be successfully run and the tester needs to be notified by the system and hear the sound samples.

TestSummary

Democodesuccessfullyrun Testernotifiedandsamplesplayed



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SoftwareTestCase4:Testing of our algorithm, so that once the conductivity measured from the sensors exceeds a certain value, immediate instructions will be displayed on the LCD screenMethod of Testing:

The tester will run the demo code that will check and ensure if the algorithm is passed successfully. If it is successful, the system will immediately stop the current process and

notify user.


In order for this test to pass, the demo code needs to be successfully run and the tester needs to be notified by the system and must be able to see system instructions displayed on the LCD screen.

TestSummary

Democodesuccessfullyrun Testernotifiedandinstructionsdisplayed



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AppendixB:UIDesign

1.0 Introduction

Medicaldevicescanbecomplicatedequipmenttooperate,manyofwhicharehandledbytrainedmedicalprofessionalssuchasdoctorsorlabtechnicians.ThismotivatesCFTRSolutionstodesigntheusabilityoftheCFScannertoapointwhereanon-medicalprofessionalcanoperatethedeviceandobserveresultseasily.Sincemanydevelopingcountriesdonothaveaccesstoadvancemedicallabsortechnicians,designinganeasyandintuitivedeviceremovesthatinfrastructurethatwasoncenecessary.ThisdocumentwilloutlinewhyCFTRSolutionsaimstoachievesuchalevelofusability,aswellasourapproach.Itwillcovervariousmechanismssuchasastep-by-stepvoice-overfeatureandothersthatwillmakethedeviceusableforanuntrainedperson.

2.0UserAnalysis

CFScannerisdesignedinawaythatbothtrainedmedicalprofessionalsandregularuserscanoperatethedeviceeasily.Therefore,havinganintuitiveandcleanuserinterfaceiscrucial.Formedicalprofessionals,thereisalmostnoextraknowledgeandnorestrictionswithrespecttotheirpriorexperiencewithsimilarsystems,asthesetupandtheproceduretouseCFScannerareprettymuchidenticaltothecurrent“goldstandard”sweattestthatmedicalprofessionalsarefamiliarwith.

Intermsofnon-medicalregularusers,therewillbesimpleaudioandvisualcommands,similartoAED,fortheuserstofollowsuchas“ApplythePilocarpineontheforearm”,“Waitfor5minutes”,and“Waitfor30minutes”.Table4comparesthecurrentsweattestprocedurewiththeproceduretoprepareandoperateCFScanner.TheonlydifferencebetweenCFScannerandcurrentsweattestisafterthesweatbeinginduced.Theproceduretoinducethesweatforbothmethodsisidentical.(thestepsabovetheredline)

Apartfromthat,thereisalmostnorestrictionontheusers’physicalabilitiesasCFScannerisacompactdevicethatislightandsmall.Thedeviceprovidesbothvisualinstructionsandaudioinstructionssimultaneouslywhichwillensurepeoplewithdisabilitiescanstilloperatethedevicecorrectly.CFScannerisalsodesignedtoprovideasmuchusersupportaspossible.Forinstance,oncethewaittimehaselapsed,thenextstepbuttonwillbecomegreentoinformtheusers.Theaudioandvideoinstructionswithinastepwillalsorepeatthemselvesafterashortperiodoftime.

Table4.ProcedureDifferenceBetweenSweatTestandCFScanner

SweatTest CFScannerVisuallycheckconditionofpowerpack,connections,andelectrodes.

Visuallycheckconditionofpowerpack,connections,andelectrodesandCFScanner.

Selectsitesforiontophoresis,mostlyinner Selectsitesforiontophoresis,mostlyinner

34

surfaceoftheforearmwithhairlessarea. surfaceoftheforearmwithhairlessarea.Wipecleanthepatient’sforearmwithMediswab(SkinCleansingSwabwith70%IPA)

Wipecleanthepatient’sforearmwithMediswab(SkinCleansingSwabwith70%IPA)

Dryforearmwithtissuethenmoistentheselectedareawithdeionizedwaterandwoolball

Dryforearmwithtissuethenmoistentheselectedareawithdeionizedwaterandwoolball

Applypilocarpinegelontotheselectedareatoinducesweatingandcovertheareawithgauzepad

Applypilocarpinegelontotheselectedareatoinducesweatingandcovertheareawithgauzepad

Electrodesareplacedoverthegauzepadandamildcurrentwillbeappliedfor5minutes

Electrodesareplacedoverthegauzepadandamildcurrentwillbeappliedfor5minutes

After5minutes,removetheelectrodesandthepadsthenwipecleantheforearmagain

After5minutes,removetheelectrodesandthepadsthenwipecleantheforearmagain

Placegauzepadontotheselectedareatightlyandwaitfor30minutestocollectthesweat

Placegauzepadontotheselectedareatightlyandwaitfor30minutestocollectthesweat

Putthegauzeinacontainerandsendtoamedicallabforanalysis

ApplyCFScannerontothesweatingareatorunanalysis

3.0TechnicalAnalysis:[1]

3.1DiscoverabilityTheabilityoffindingcontrols,switchesandcontentofamedicaldeviceofcrucialtodesigningasimpleandintuitivedesign.Thefollowingdiscoverabilityfeatureswillbeimplementedtoachievesuchafeat:

• Apoweron/offbuttonvisiblyavailableonthecornerofthedevicedictatestheon/offmodeandthebatterypercentagewillbedisplayedontheLCD

• Sincethemedicalprocedureofobtainingsweatfrompatientsissequential,themajorityofthepossibleactionsarerestricted.AnLCDscreencombinedwithaspeakerwillguidetheusertothenextstepintheprocess.

• Anasynchronousresetbuttonwithconfirmationwillbeavailableatalltimes.

3.2FeedbackGiventhelinearityofthemedicalprocedure,theusermustknowabouttheircurrentstatewhileusingthedevice.ThisgivesrisetotheLCDdisplayandvoice-overspeakerthatwillguidetheuserthroughtheoperation.

• Agreetingtotheoperationprocedurewillbeemittedwhenthedeviceispoweredon.• Aconfirmationwillberequestedwhenthedeviceisbeingpoweredoff.• TheLCDwilloutputthecurrentstatealongwithatimerofhowlongtheyshouldbeinthatstate

for.• Aspeakerguidestheuserthroughexactlywhattodointhestate.

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3.3AffordancesInordertoexecutethedesireddesign,thedevicemustbeintuitivetotheuser.Inorderfortheusertoperceiveourdevicenaturally,weimplementedthefollowingfeatures:

• Apowerbuttonwillbeplacedonthecornerofthedeviceandinaredcolor.• Aspreviouslystated,theuserwillbeguidedthroughtheentiremedicalprocedurewithaLCD

andavoice-over.• Thepilocarpinegelwillbestoredwithinastoragecompartmentthatcanbeeasilyaccessedwith

alatchlockingmechanism.Thelatchlockingmechanismwillbeadjacenttothecompartmentitself.

3.4SignifiersToguidetheuserthroughourintendeddesignactions,wewillusesubtleyetinformativelabels.Thefollowingsignifierscanbefoundthroughoutourdesign:

• Thepowerbuttonislabeledwithapowersymboltoindicatethefunctionalityofthebutton.• Aconfirmationwillberequestedbythedevicepriortoturningoffthedevice,whichisdoneby

theLCDandthespeaker.• EachstepinthemedicalprocedurewillresultintheLCDtochangeitsoutput,aswellasa

differentinstructionemittedbythespeaker.• Asymbolwillbeembeddedonthelatchlockingthecompartmentholdingthepilocarpinegel.

3.5MappingsThecontrolsforthedevicemustintuitivelycorrespondtotheiractions;thiscanbeexplainedingreaterdetailbelow:

• Controls,suchaspowerbutton,aremountedintothedevicethatistobecontrolled.• Thelatchcontrollingthelockofthecompartmentholdingthepilocarpinegelshallbeadjacent

tothecompartment,makingitintuitivethatitinfactencapsulatesthegel.

3.6ConstraintsByaddingconstraintsintothedesign,itclarifieshowtouseourdeviceandwhateachmoduleismeantfor.Therefore,thefollowingconstraintsonourdeviceshallbeimplemented:

• Thedeviceshallbephysicallyconstrainedanditistobeheldwithasinglehand,byrestrictingthephysicaldimensionsandtheweightofthedevice.

• Eachstepinthemedicalprocedurewillbetemporallyconstrainedbyasoftwaretimerandaspeakerthatwilldictatewhentoproceedtothenextstep.

• Semantically,thevoice-overguidewillbeusingnomedicaljargon,astosimplifytheinstructionsandemphasizetheuseofthisdevicetonon-medicalprofessionals.

3.7ConceptualModelUsingthesixabovedesignelements,wecancreateaclearconceptualmodelfortheCFScanner.

36

• Amedicaldevicethatallowsnon-medicalprofessionalstoconductasweattestandobservetheresults.

• AcombinationofanLCDandavoice-overtutorialthatwillguidetheuserthroughtheprocedure,andthereforeeliminatetheoncenecessarymedicalinfrastructurefortraditionalsweattests.

4.0EngineeringStandards:[2]

CFScanner’sUIisdesignedtobecomplywithISO9241whichisamulti-partstandardfromtheInternationalOrganizationforStandardizationcoveringergonomicsofhuman-computerinteraction.ThefollowingstandardswillbeusedasguidanceforCFScannerUIdesign.

• ISO9241-11dealswiththeextenttowhichaproductcanbeusedbyspecifieduserstoachievespecifiedgoalswitheffectiveness,efficiency,andsatisfactioninaspecifiedcontextofuse.

• ISO9241-12containsspecificrecommendationsforpresentingandrepresentinginformationonvisualdisplays.Itincludesguidanceonwaysofrepresentingcomplexinformationusingalphanumericandgraphical/symboliccodes,screenlayout,anddesignaswellastheuseofwindows.

• ISO9241-13providesrecommendationsforthedesignandevaluationofuserguidanceattributesofsoftwareuserinterfacesincludingPrompts,Feedback,Status,On-lineHelpandErrorManagement.

• ISO9241-14providesrecommendationsfortheergonomicdesignofmenususedinuser-computerdialogues.Therecommendationscovermenustructure,navigation,optionselectionandexecution,andmenupresentation.

• ISO9241-15includesrecommendationsfortheergonomicdesignofcommandlanguagesusedinuser-computerdialogues.Therecommendationscovercommandlanguagestructureandsyntax,commandrepresentations,inputandoutputconsiderations,andfeedbackandhelp.

• ISO9241-16containsrecommendationsfortheergonomicdesignofdirectmanipulationdialogues,andincludesthemanipulationofobjects,andthedesignofmetaphors,objectsandattributes.ItcoversthoseaspectsofGraphicalUserInterfacesthataredirectlymanipulated,andnotcoveredbyotherpartsofISO9241.

• ISO9241-210providesguidanceonhuman-systeminteractionthroughoutthelifecycleofinteractivesystems

4.1AnalyticalUsabilityTestingTheintensionofthismedicaldeviceistobeusedbyuserswhocouldbeuntrainedinthemedicalfield;ourdesignmustbeminimalisticincomplexity.ThedeviceisguidedviaanLCDandavoice-over;thegeographicalregionofthedevicemustcorrespondtothesemanticsoftheinstructions.Theinstructionsmustbeemittedinlayman’stermsandunambiguous.Thepowersupplymustbeprotectedfromexternalharm,andadjacenttothebatteryholderwillbeastickerinstructingcompatiblebatteriesonly.Sincethedeviceinducesaminimal0.4mAcurrentduringonephaseofthemedical,asasafetyprecautiontherewillbeaacurrentsafetycut-outandanautomatictimerthatwillbothinstructthe

37

usertoproceedtothenextstepandautomaticallyshutoffthecurrentifithasbeeninducedfortoolongorhasgoneoveralimit.Thecompartmentencapsulatingthepilocarpinegelwilldisplayastickerthatwillinstructtheusertoonlyusegelsfromarecognizedmanufacturer,andusingalatchmechanismwilllockthecompartment.

4.2EmpiricalUsabilityTestingDifferentuserswilltesttheCFScanneratdifferentstagesoftheproductdevelopmenttoensuregreatusability.Wheneverthereisaniterationdoneonthedevice,theCFScannerwillbemodifiedbasedonthefeedbackfromtheusersatthedifferentstages.

Forthefirststage,trainedmedicalprofessionalswhohavehadexperiencewithCysticFibrosispatientsandsweattestwillbetestingtheCFScanner.Theywillbeaskedtoperformthetraditionalsweattestononeoftheforearm’sofapatient,andthenuseCFScannerontheotherforearm.Bydoingdirectcomparisonlikethis,themedicalprofessionalscanexperiencetheworkflowdifferencebetweenthesweattestandCFScanner.TheywillhavegoodideahowCFScannerworkscomparestotheirpriorexperience.Themedicalprofessionalscanalsogiveconstructivefeedbackonwhethertheaudioandvisualinstructionsareaccurateandeasytofollow.Thedesignteamcanobtainthesefirst-handuserexperiencefromthemedicalprofessionalstofurtherimprovetheUI,audioandvisualinstructions.

Intermsofthesecondstage,theCFScannerwillbetestedbyagroupofmedicalprofessionalsthatlacksexperiencewhenitcomestoexecutingsweattests.TheywillbeaskedtouseCFScanneronpatients.TheywillbelearninghowtoperformastandardCFscreeningtestusingCFScanner.Thestepsandprocedurethattheyhavedifficultywithwillberecordedandexamined.Thisstageoftestingcanhelpthedesignteamtodeterminewhetherthereisanylearningdifficulty.ThenthenextimplementationwillimproveonmakingCFScannermoreintuitiveanduserfriendly.

Inthirdstage,regularuserswhodonothaveanyknowledgeregardingmedicalequipmentwilltesttheCFScanner.Atthisstage,CFScannershouldhavefairlystraightforwarduserinterfaceandclearinstructionsonhowtooperatethedevice.However,theprevioustestusersaremedicalprofessionals,theyhavemoreexperienceusingmedicaldeviceonothersandsomerelatedmedicalknowledgethatregularpeopledon’thave.Therefore,havingregularuserstotestCFScannercanmakesureouruserinterfacedoesnothavejargonsthatotherusesmightbeconfusedaboutandouraudioandvisualinstructionsareinformative,clearandeasytofollow.ThedesignteamcanreceivethefeedbackanduseittofinetuneCFScannerbeforethefinalstage.

Forthelaststage,alluserslistedabovewillbetestingCFScanneragaintoensureregressiontestingisdoneproperly.Atthisstage,thedesignteamwillneedtoconsiderthefeedbacksfromeachgroupandcomeupwithabestuserinterfaceforCFScanner.

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4.3GraphicalPresentation

Figure10SolidworksschematicfortheCFScanner[3],[4]

Figure10showsaSolidworksschematicoftheCFScanner.Aspreviouslystated,itisequippedwithaLCDscreentodisplayresultsandtoguidetheuserthroughthemedicalprocedure.Aspeakerwillemitavoicetutorialtoassist.Aredpowerbuttonwiththepowersymbolisavailableatthetopcorner,followingaconventionaldesigntoeaseusability.

5.0Conclusion

Theuserinterfacedesignofamedicaldeviceiscrucialtotheusabilityandtheexecutionofthemedicalprocedure.CurrentlytheCFScannerhasastrongconceptualfoundation.UsingacombinationoftheLCDandvoice-overspeaker,itwillguidetheuserthroughtheentiremedicalprocedure.Themechanicalbuttonssuchaslatchesandswitcheswillusesignifyingmarkerstoindicatetheirfunctionality,aswellasinstructionsforreplacingbatteriesandpilocarpinegel.Themajorconcernwithrespecttouserinterfaceistheuncertaintywithregardstopracticallytestingaprototype.Withoutademowedonotknowforcertainifalluserscansemanticallyinterpretcorrectly.Thiscanbeverifiedbycreatingaliveprototypeanddisplayademoforuserstotest.Therefore,oncetheprototypeisconstructed,theempiricalusabilitytestingmustbedoneproperlyateachstageofthedevelopmenttoensuregreatusabilityofCFScanner.

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ReferencesforAppendixB:UIDesign

[1]S.,“7fundamentalsofdesign–andhowtheyapplytoonlinespaces,”Socialinsilico,27-Jan-2015.[Online].Available:https://socialinsilico.wordpress.com/2015/01/27/7-fundamentals-of-design-and-how-they-apply-to-online-spaces/.[Accessed:28-Mar-2017].

[2]“Userinterfacedesign,”Wikipedia,23-Mar-2017.[Online].Available:https://en.wikipedia.org/wiki/User_interface_design.[Accessed:27-Mar-2017].

[3]M.Miladi,"GrabCAD-CADlibrary",Grabcad.com,2017.[Online].Available:https://grabcad.com/library/arduino-uno-13.[Accessed:14-Feb-2017].[4]B.Grissim,"GrabCAD-CADlibrary",Grabcad.com,2017.[Online].Available:https://grabcad.com/library/orion-mid-range-speaker-1.[Accessed:28-Mar-2017].

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