prosthetics and orthotics manufacturing guidelines - 1 ... · pdf filemission the...
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Partial Foot ProsthesisPhysical Rehabilitation Programme
Manufacturing guidelines
0868
/002
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06
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.
Acknowledgements:
Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoestmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
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Table of contents
Foreword 2Introduction 41.Footprintofsoundside 52.Castingandrectification 63.Softsocketfabrication 74.Forefootbuild-up 115.Firstfittingofsoftsocket 136.Drapingofpolypropylene 157.Trimlines 178.Fitting 209.Straps 2110.Finishedpartialfootprosthesis 22Listofmanufacturingmaterials 23
Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
Foreword
The ICRC polypropylene technology
Sinceitsinceptionin1979,theICRC’sPhysicalRehabilitationProgrammehaspromotedtheuseoftechnologythatisappropriatetothespecificcontextsinwhichtheorganizationoperates,i.e.,countriesaffectedbywarandlow-incomeordevelopingcountries.
Thetechnologymustalsobetailoredtomeettheneedsofthephysicallydisabledinthecountriesconcerned.
Thetechnologyadoptedmustthereforebe:
• durable,comfortable,easyforpatientstouseandmaintain;• easyfortechnicianstolearn,useandrepair;• standardizedbutcompatiblewiththeclimateindifferentregionsoftheworld;• low-costbutmodernandconsistentwithinternationallyacceptedstandards;• easilyavailable.
Thechoiceoftechnologyisofgreatimportanceforpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreferredtodevelopitsowntechniqueinsteadofbuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.ThecostofthematerialsusedinICRCprostheticandorthoticdevicesislowerthanthatofthematerialsusedinappliancesassembledfromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanufacturedlocally.Intheearly1990stheICRCstartedtheprocessofstandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,forthesakeofharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityofservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988forthemanufactureofprostheticsockets.Thefirstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponentssuchasvariousalignmentsystemswerefirstdevelopedinColombiaandgraduallyimproved.Inparallel,adurablefoot,madeinitiallyofpolypropyleneandEthylVinylAcetate(EVA),andnowofpolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberfoot.
In1998,aftercarefulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertofocusonpatientcareandtrainingofpersonnelatcountrylevel.
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
Objective of the manuals
TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.
Themainaimsoftheseinformativemanualsareasfollows:
• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.
Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Introduction
Theaimofthisdocumentistodescribeamethodforproducingpartial foot prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysicalRehabilitationCentreinBattambang,Cambodia.
Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.
Remarks
• Theproceduredescribedrelatestooneofthemostcommontypesofpartialfootamputation,whichisalsoknownasChoppartormid-footamputation.
• Iffullendbearingisnotpossible,thePatellar-Tendon-Bearing(PTB)designbrimshouldbeused.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
FOOTpRInT OF sOund sIde1
6Copythesound-sidefootprintonasheetofpaperandmarkthefootrotation(~10°).
Insertfrontalline.
6Fixthepaperagainstawindowandcopythereversesideofthefootprint.
Theprintwillhelpinpositioningthebuild-upofthefootontheprosthesis.
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
CasTIng and ReCTIFICaTIOn2
PatientassessmentandcastingareperformedinaccordancewithP&Ostandards.However,thecastistakenwhiletheamputeeissittingdown.Patientswhowillhavetheirfullweightbearingontheprosthesisshouldstandbeforetheplasterbandageshavehardened.Formoresensitivestumpsthepatientshouldstandonalayerofsoftfoam,andifnecessaryaheelwedgemaybeaddedtocompensateforequinuspositionofthestumportheheightoftheshoeheel.
Caremustbetakentoensurethatthecalcaneusisheldinaneutralposition.
RectificationofthepositivecastimpressionisperformedinaccordancewithP&Ostandards.
6Referencelinescanbeaddedonthemouldsandthefootprint.
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ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
sOFT sOCkeT FabRICaTIOn3
MeasurementofEVAfoam:
� Circumference2cmabovetheheadofthefibula.� Circumferencemiddleofthecalcaneus.� Lengthofplastercast.
Cutatrapezoidfromasheetof6mmEVAfoamaccordingtotheabovemeasurements.
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
4Trima10mmstriponbothlateralsidesoftheEVAfoamtozeromillimetres.
4ApplyNeoprenecontactgluetwiceonbothtrimmedsides.
4Oncetheglueisdry,jointhetwosurfacestoformacone.
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
4DusttheplasterpositiveandtheinsideoftheEVAconewithtalcumpowdertofacilitatesliding.
4HeattheEVAconeinanovenforabout5minutesat120°Candthenpullitovertheplasterpositive.
4TokeeptheEVAfoaminthesameshapeastheplasterpositive,secureitwithelasticbandagesorplaceitundervacuumuntilithascooleddown.
�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
4TrimthedistalsectionoftheEVAconewithaknifeandsmoothitbygrinding.
4ApplytwolayersofNeoprenecontactgluetothetrimmedsectionandtothe12mmEVAfoamsocketcap.
4Heatthecapfor2to3minutesat120°Cinanovenandglueitontothesoftsocket.
CutoffandgrindtoremovetheexcessEVAfoam.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
FOReFOOT buIld-up4
4Gluelayersof12mmEVAfoamcorrespondingtothelengthofthesoundfootmeasuredbeforecasting.
4Usethefootprinttakenbeforecastingtodeterminethecorrectfootrotation.
Checktheanterior/posteriorandthelateral/medialalignmentsagainstthemeasurementcard(e.g.heelheight).
6Pre-shapetheforefootwithaknife.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
6Finishshapingtheforefootonthegrindingmachine.
Makesurethattheplantarsolebetweenheelandtoesisparalleland,ifnecessary,thattheheelheightiscorrect.Wherepossible,shapethelongitudinalarchsupport.
6Forfinishing,asheetof3mmEVAfoamisdrapedoverthefoot.
FitthesheetofEVAfoamonthefootbycuttingitroundaroundtheankle.
ApplytwolayersofNeoprenecontactglue,thenheatthe3mmEVAfoamintheovenfor2minutesat120°Cbeforedrapingit.Cutandsmooththeedges.Afurthersheetof3mmEVAfoammaybeadded(glued)tothesole.
Thisoperationcanalsobecarriedoutafterthefirstfittingofthesoftsocketontheamputee,describedbelow.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
FIRsT FITTIng OF sOFT sOCkeT5
4Beforethepolypropyleneisdraped,thesoftsocketmustbecheckedonthepatient.
Thesoftsocketmustberemovedfromtheplasterpositivewithoutbreakingit.
Ontheposteriorside,puncha4mmholejustabovethecalcaneus.ThishelpsavoidtearingoftheEVAfoamwhenthesoftsocketisbeingremovedfromtheplaster.
Drawalineorusearulertomakeastraightcuttinglineuptotheproximalendofthesocket.
Removethesoftsocketcarefullyandkeeptheplasterpositive.
6Tocheckthefit,alignmentandlengthofthesoftsocket,fixitwithtape.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
6Checktheheightoftheprosthesisanditsstaticalignment.Makethenecessarymodifications/correctionsbygrindingofforaddingEVAfoam.
6Checkalsothelengthandrotationofthefoot,andadjustitasdescribedabove.
Atthispointitisnotrecommendedthatthepatientbeallowedtowalk,asthesocketandforefootaretooflexible.However,theamputeemaytakesomestepsinsideparallelbarssothatthedynamicalignmentcanbechecked.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
dRapIng OF pOlypROpylene6
4Putthesoftsocketbackontheplasterpositiveandstapleortapethesidesoftheposteriorseamtogether.
4Measurementofpolypropylenesheet:
Lengthfromproximalpartofplasterpositivetotoes+15cm
Circumferenceofproximalpartofsoftsocket+2cm
Circumferenceofmid-tibialsection+2cm
Circumferenceoffoot-ankle(below
medialmalleoli,includingcalcaneus)+5cm
4Beforedrapingthepolypropylene,pullanylonstockingoverthesoftsocketanddustitwithtalcumpowder.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
4Cuta5mmsheetofPPcorrespondingtothemeasurementstakenabove.
HeatthePPinanovenforabout20minutesat180°C.
4LaythePPoverthemouldwithoutstretchingit.
Drapeitfirstovertheankletowardsthemiddleanteriorpartoftheprosthesis.Thenpullitaroundtheforefoot.
4FinishdrapingthePPandstickittogetheralongthemiddleanteriorsideoftheprosthesis.
TightenthePParoundthesuctionconewithabicycleinnertube,aropeorastockingandopenthevacuumvalve.
4Withscissorsoraknife,cutofftheexcessalongtheweldingseamwhilethePPisstillhot.
4Keepthevacuumonforabout5min.,butwaituntilthePPhascompletelycooleddownbeforeremovingthemouldfromthevacuumcone.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
TRIm lInes7
4Proximaltrimline: 1to2cmbelowthefibulahead.
Lateral/medialtrimlines: On1/3oftheproximaltibialsection,
2to3cmwiderthanthe2/3distaltibialtrimline,whichisdrawnstraightupjustbehindthelateralandmedialmalleoli.
Distal/posteriortrimline: Alongthecalcaneustuberosity.
6Forefoottrimline: 5mmposteriortothe1stmetatarsaltodistalphalanges,butkeepthePPtipforprotectionofthe
EVAfoam.
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4Removethesoftsocketfromtheplasticsocket.BearinmindthatitmightbedifficulttoextractthesoftsocketfromthePPshell.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
4Cuttheposterioropeningwithanoscillatingsaw.
4ToavoiddamagingtheEVAfoam,donotcuttheforefootopeningwithanoscillatingsaworknife.Instead,carefullygrinditoff.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
6GrindtheanteriorPPweldingseamdownto5mmandshapethetrimlinesoftheplasticandsoftsockets.
6Shapealsothetrimlinesoftheforefootopening.
�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
FITTIng8
6Duringfittingandgaittraining,fixtheproximalpartoftheprosthesiswithtape.
Modificationscanstillbemadetothealignment,especiallytocorrecttheeversionorinversionofthefoot,andtotheheelheightbyaddingEVAfoamonthesole.
Iftheprosthesisistoolong,compensateforthedifferenceinlengtheitherinsidetheshoeoronthesoleofthesoundleg.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
sTRaps9
4PositionaVelcrostrap(width:25or40mm)justbelowthefibulahead.
4FixthelooponthemedialwallandtheVelcrostraponthelateralwallwithtubularrivets.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
FInIshed paRTIal FOOT pROsThesIs10
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Par t ia l Foot Prosthesis
ICRC Code Description Unit of measure Quantity
MDREBANDP12 Plaster bandages 12 cm Each According to stump dimension
OMIS Plaster of Paris Each According to cast dimension
OPLAEVAFERA03OPLAEVAFERA06OPLAEVAFERA12
OPLAEVAFKIN03OPLAEVAFKIN06OPLAEVAFKIN12
OPLAEVAFLIV03OPLAEVAFLIV06OPLAEVAFLIV12
EVA foam 3 mm, terra brownEVA foam 6 mm, terra brownEVA foam 12 mm, terra brown
EVA foam 3 mm, beigeEVA foam 6 mm, beigeEVA foam 12 mm, beige
EVA foam 3 mm, oliveEVA foam 6 mm, oliveEVA foam 12 mm, olive
Each According to cast dimension
OHDWGLUENEO4 Glue, Neoprene contact Each According to soft socketOMIS Tubular nylon stocking 60 mm for PP draping Each 1 length according to
prosthesisOPLAPOLYCHOC05
OPLAPOLYSKIN05
OPLAPOLYLIV05
Polypropylene 5 mm, terra brown
Polypropylene 5 mm, beige
Polypropylene 5 mm, olive
Each According to cast dimension
OSBOSTRVP325
OSBOSTRVP440
Velcro strap with loop 25 mmorVelcro strap with loop 40 mm
Each 1 length according to patient size
OHDWRIVET081
OHDWRIVET131
Tubular rivet 8 mm x 9 mmorTubular rivet 13 mm x 12 mm
Each 2
list of manufacturing materials
MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.
Acknowledgements:
Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
0868
/002
0
9/20
06
200