RiskPriority

Detection

Occurrence

CorrectiveorPreventativeMeasure

Severity

RiskPriority

Effect

Detection

Failure

Occurrence

NOTE:RiskPriority=SeverityxOccurrencexDetection

Severity

FMEAofFinalDesignConceptBalanceTrainingBicycle

TiltResistanceMechanism:
Mechanismfails(cableorconnections
break).

Bikefallstogroundresultinginpatient/PT
injury.

Pinchpoints.

InjurytoPT/patient.
Winchlocksatthecurrentposition.Unable
tochangetiltresistancelevel.

Powertowinchisshutoff.

Winchexceedsrangelimitofspring
compression.

Damagetohandlebarpost.Damageto
pulleysystem.

Secondbackupcableattachedbetween
81 handlebarsandpulleystand.
Placecover/guardoverentiretiltresistance
6 mechanism.
1 Noneneeded.
Usetravellimitswitchonwinchtocutoff
powerwhenspecifiedpointincableis
exceeded.Or,placewinchstopperoncable
tomakeaudiblenoiseandtostoppullofcable
15 whenspecifiedpointoncableisreached.

18

21

Axle:
Axlecouldshiftforwardifkicked,or
duringtransprtation.

Bikecouldbecomeunstablewhilepatientis
riding.Resultinpatientinjury.Premature
wearandrubbingbetweenbearingsand
seat/handlebarposts.

Crossmemberisatriphazard.

Patienttripsandfalls.

Handlebarscouldfallwhenangleisbeing Injurepatientbybruising.Strikeanddamage
adjusted.
partofbike.Breakadjustmenthinge.

Bacteriagrowthonhandlegrips.

Spreadofgermsbetweenpatients/PT.

PTinjuresthemselftryingtoliftbike(even
withwheelbarrowdesign).

Turnagrooveintotheaxlethatthesetscrewin
thebearingwillrestin,topreventaxlefrom
81 slidingforward/backward.
Keepcrossmemberaslowaspossible.(Below
63 12inches.)

Handlebars:
35 Handlebarhingerotatesto65degreesmax.
Usegripsthataremadeoutofmaterialthatis
abletobewipeddown/cleaned
189 (rubber/plastic/nylon/leather).

Portability:
Heavyweightofbike.

Ensuretheforcenecessarytolifttherearofthe
36 bikeisnomorethan35pounds.

RiskPriority

Detection

Occurrence

CorrectiveorPreventativeMeasure

Severity

RiskPriority

Detection

Occurrence

Effect

Severity

Failure

SteelFrame:
Rusting/deteriorationofsurfaceonsteel Roughsurface,weakenedstrengthof
assembly.
materialresultinginbikeframefailure.

Entirebikeframebecomesunstableon
fallsoverwhileinuse.

PatientandPTinjury.

18

Anodize/protectivecoating(paint)onmetal
54 framematerials.
Supportlegsextendoutfarenoughto
counteractthemomentcreatedbytheheaviest
54 (300lbs)patient.

Usespringplungerpinthatautomatically
engagesintoaccessibleslot.Useofcolor,i.e.
redwhennotfullyseated,clickinplace(sounds
andfeel).Tubetoguidepinthroughentireshaft
(maynotbenecessarywithsmalldiameter
175 shaft).

14

20

SpringLoadedPinAdjustments:

Pindoesnotfullyengagewhenmaking
adjustments.

Handlebars/seatunexpectedmovement
whenweightapplied.Patientcouldbe
startled,fall.

Bikefailsunderpatientweight.

HumanError:
Recommendedweightlimitisexceeded.

Patientattemptstomountbikewhileitis
notintheUprightLockedPosition.
Patientinstabilityresultingininjury.

PTtripsoverbacksupportlegs.

Annoyance,injurytoPT/patientfromfall.

Handslippingoffhandlebar.

Patientinstability.

Footslippingoffpedal.

Patientinstability.

Patientslippingoffseat.

Patientfallsresultingininjury.

PlacehighlyvisibleWeightLimitwarning
45 label/sticker(frontofhandlebars).
WarningLabel/stickeronsideofseat:Place
bikeinUprightLockedPositionBEFORE
50 mounting(possiblyusepictureillustration).
Placeantifatiguerubbermatwithcutouts
aroundsupportlegstoprovideflatstanding
70 platform.
Useergonomicrubbergrips,andplacetear
5 awayhandstrapsonhandlebars.
Usepedalsfittedwithrubberfootstrapsto
allowfoottoslideback,butnotforwardorside
15 toside.
ItisassumedthatthePTwillusetheVelcroBelt
onallpatients,andwillhavecontrolofpatient
atalltimes.Usetexturedseattoincrease
9 friction.