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Partial Foot Prosthesis
Physical Rehabilitation Programme
Manufacturing guidelines
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International Committee of the Red Cross
19 Avenue de la Paix
1202 Geneva, Switzerland
T + 41 22 734 60 01 F + 41 22 733 20 57
E-mail: [email protected]
www.icrc.org
ICRC, September 2006
All photographs: ICRC/PRP
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T of cott
Foreword 2
Introduction 41.Footprintosoundside 5
2.Castingandrectication 6
3.Sosocketabrication 7
4.Foreootbuild-up 11
5.Firstttingososocket 13
6.Drapingopolypropylene 15
7.rimlines 17
8.Fitting 20
9.Straps 21
10.Finishedpartialootprosthesis 22
Listomanuacturingmaterials 23
Manufacturing Guid el ines P art ial Foot P rosthesis
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Forwor
T ICRC oro tcoo
Sinceitsinceptionin1979,theICRCsPhysicalRehabilitationProgrammehaspromotedtheuseotechnologythatisappropriatetothespeciccontextsinwhichtheorganizationoperates,i.e.,countriesaectedbywarandlow-incomeordevelopingcountries.
Tetechnologymustalsobetailoredtomeettheneedsothephysicallydisabledinthecountriesconcerned.
Tetechnologyadoptedmustthereorebe:
durable,comortable,easyorpatientstouseandmaintain; easyortechnicianstolearn,useandrepair; standardizedbutcompatiblewiththeclimateindierentregionsotheworld; low-costbutmodernandconsistentwithinternationallyacceptedstandards; easilyavailable.
Techoiceotechnologyisogreatimportanceorpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreerredtodevelopitsowntechniqueinsteadobuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.TecostothematerialsusedinICRCprostheticandorthoticdevices
islowerthanthatothematerialsusedinappliancesassembledromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanuacturedlocally.Intheearly1990stheICRCstartedtheprocessostandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,orthesakeoharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityoservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988orthemanuactureoprostheticsockets.Terstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponents
suchasvariousalignmentsystemswererstdevelopedinColombiaandgraduallyimproved.Inparallel,adurableoot,madeinitiallyopolypropyleneandEthylVinylAcetate(EVA),andnowopolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberoot.
In1998,aercareulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertoocusonpatientcareandtrainingopersonnelatcountrylevel.
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Ojctiv of t
TeICRCsManuacturingGuidelinesaredesignedtoprovidetheinormationnecessaryorproductionohigh-qualityassistivedevices.
Temainaimsotheseinormativemanualsareasollows:
opromoteandenhancestandardizationoICRCpolypropylenetechnology; oprovidesupportortrainingintheuseothistechnology; opromotegoodpractice.
Tisisanothersteporwardintheeorttoensurethatpatientshaveaccesstohigh-qualityservices.
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Itroctio
Teaimothisdocumentistodescribeamethodorproducingpartial foot prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysical
RehabilitationCentreinBattambang,Cambodia.
Tecasting,recticationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsopracticeandarethereorenotdescribedintheseICRCmanuacturingguidelines.
Rr
Teproceduredescribedrelatestooneothemostcommontypesopartialootamputation,whichisalsoknownasChoppartormid-ootamputation.
Iullendbearingisnotpossible,thePatellar-endon-Bearing(PB)designbrimshouldbeused.
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FOOTpRInT OF sOund sIde1
6Copythesound-sideootprintonasheetopaperandmarktheootrotation(~10).
Insertrontalline.
6Fixthepaperagainstawindowandcopythereversesideotheootprint.
Teprintwillhelpinpositioningthebuild-upotheootontheprosthesis.
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CasTIng and ReCTIF ICaTIOn2
PatientassessmentandcastingareperormedinaccordancewithP&Ostandards.However,thecastistakenwhiletheamputeeissittingdown.
Patientswhowillhavetheirullweightbearingontheprosthesisshouldstandbeoretheplasterbandageshavehardened.Formoresensitivestumpsthepatientshouldstandonalayerosooam,andinecessaryaheelwedgemaybeaddedtocompensateorequinuspositionothestumportheheightotheshoeheel.
Caremustbetakentoensurethatthecalcaneusisheldinaneutralposition.
RecticationothepositivecastimpressionisperormedinaccordancewithP&Ostandards.
6Reerencelinescanbeaddedonthemouldsandtheootprint.
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2
1
3
Manufacturing Guid el ines P art ial Foot P rosthesis
sOFT sOCkeT FabRICaTIOn3
MeasurementoEVAoam:
Circumerence2cmabovetheheadothebula. Circumerencemiddleothecalcaneus. Lengthoplastercast.
Cutatrapezoidromasheeto6mmEVAoamaccordingtotheabovemeasurements.
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4rima10mmstriponbothlateralsidesotheEVAoamtozeromillimetres.
4ApplyNeoprenecontactgluetwiceonbothtrimmedsides.
4Oncetheglueisdry,jointhetwosuracestoormacone.
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4DusttheplasterpositiveandtheinsideotheEVAconewithtalcumpowdertoacilitatesliding.
4HeattheEVAconeinanovenorabout5minutesat120Candthenpullitovertheplasterpositive.
4okeeptheEVAoaminthesameshapeastheplasterpositive,secureitwithelasticbandagesorplaceitundervacuumuntilithascooleddown.
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FOReFOOT buIld-up4
4Gluelayerso12mmEVAoamcorrespondingtothelengthothesoundootmeasuredbeorecasting.
4Usetheootprinttakenbeorecastingtodeterminethecorrectootrotation.
Checktheanterior/posteriorandthelateral/medialalignmentsagainstthemeasurementcard(e.g.heelheight).
6Pre-shapetheoreootwithaknie.
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FIRsT FITTIng OF sOFT sOCkeT5
4Beorethepolypropyleneisdraped,thesosocketmustbecheckedon
thepatient.
Tesosocketmustberemovedromtheplasterpositivewithoutbreakingit.
Ontheposteriorside,puncha4mmholejustabovethecalcaneus.TishelpsavoidtearingotheEVAoamwhenthesosocketisbeingremovedromtheplaster.
Drawalineorusearulertomakeastraightcuttinglineuptotheproximalendothesocket.
Removethesosocketcareullyandkeeptheplasterpositive.
6ocheckthet,alignmentandlengthothesosocket,xitwithtape.
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6Checktheheightotheprosthesisanditsstaticalignment.Makethenecessarymodications/correctionsbygrindingooraddingEVAoam.
6Checkalsothelengthandrotationotheoot,andadjustitasdescribedabove.
Atthispointitisnotrecommendedthatthepatientbeallowedtowalk,asthesocketandoreootaretooexible.However,theamputeemaytakesomestepsinsideparallelbarssothatthe
dynamicalignmentcanbechecked.
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dRapIng O F pOlypROpylene6
4Putthesosocketbackontheplasterpositiveandstapleortapethesidesotheposteriorseamtogether.
4Measurementopolypropylenesheet:
Lengthromproximalpartoplasterpositivetotoes+15cm
Circumerenceoproximalpartososocket+2cm
Circumerenceomid-tibialsection+2cm
Circumerenceooot-ankle(belowmedialmalleoli,includingcalcaneus)+5cm
4Beoredrapingthepolypropylene,pullanylonstockingoverthesosocketanddustitwithtalcumpowder.
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4Cuta5mmsheetoPPcorrespondingtothemeasurementstakenabove.
HeatthePPinanovenorabout20minutesat180C.
4LaythePPoverthemouldwithoutstretchingit.
Drapeitrstovertheankletowardsthemiddleanteriorpartotheprosthesis.Tenpullitaroundtheoreoot.
4FinishdrapingthePPandstickittogetheralongthemiddleanteriorsideotheprosthesis.
ightenthePParoundthesuctionconewithabicycleinnertube,aropeorastockingandopenthevacuumvalve.
4Withscissorsoraknie,cutotheexcessalongtheweldingseamwhilethePPisstillhot.
4Keepthevacuumonorabout5min.,butwaituntilthePPhascompletelycooleddownbeoreremovingthemouldromthevacuumcone.
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TRIm lInes7
4Proximaltrimline: 1to2cmbelowthebulahead.
Lateral/medialtrimlines: On1/3otheproximaltibialsection,2to3cmwiderthanthe2/3distaltibialtrimline,whichisdrawnstraightupjustbehindthelateralandmedialmalleoli.
Distal/posteriortrimline: Alongthecalcaneustuberosity.
6Foreoottrimline: 5mmposteriortothe1stmetatarsaltodistalphalanges,butkeepthePPtiporprotectionotheEVAoam.
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4Removethesosocketromtheplasticsocket.Bearinmindthatitmightbedifculttoextracttheso
socketromthePPshell.
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4Cuttheposterioropeningwithanoscillatingsaw.
4oavoiddamagingtheEVAoam,donotcuttheoreootopeningwithanoscillatingsaworknie.Instead,careullygrindito.
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6GrindtheanteriorPPweldingseamdownto5mmandshapethetrimlinesotheplasticandsosockets.
6Shapealsothetrimlinesotheoreootopening.
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FITTIng8
6Duringttingandgaittraining,xtheproximalpartotheprosthesiswithtape.
Modicationscanstillbemadetothealignment,especiallytocorrecttheeversionorinversiono
theoot,andtotheheelheightbyaddingEVAoamonthesole.
Itheprosthesisistoolong,compensateorthedierenceinlengtheitherinsidetheshoeoronthesoleothesoundleg.
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sTRaps9
4PositionaVelcrostrap(width:25or40mm)justbelowthebulahead.
4FixthelooponthemedialwallandtheVelcrostraponthelateralwallwithtubularrivets.
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FInIshed paRTIal FOOT pROsThesIs10
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ICRC Code DescriptionUnit ofmeasure
Quantity
MDREBANDP12 Plaster bandages 12 cm Each According to stumpdimension
OMIS Plaster of Paris Each According to castdimension
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 castdimension
OHDWGLUENEO4 Glue, Neoprene contact Each According to soft socket
OMIS Tubular nylon stocking 60 mm for PP draping Each 1 length according toprosthesis
OPLAPOLYCHOC05
OPLAPOLYSKIN05
OPLAPOLYLIV05
Polypropylene 5 mm, terra brown
Polypropylene 5 mm, beige
Polypropylene 5 mm, olive
Each According to castdimension
OSBOSTRVP325
OSBOSTRVP440
Velcro strap with loop 25 mmor
Velcro strap with loop 40 mm
Each 1 length according topatient size
OHDWRIVET081
OHDWRIVET131
Tubular rivet 8 mm x 9 mmorTubular rivet 13 mm x 12 mm
Each 2
lit of fctri tri
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral andindependent organization whose exclusively humanitarian mission is to protect thelives and dignity of victims of war and internal violence and to provide them withassistance. It directs and coordinates the international relief activities conductedby the Movement in situations of conict. It also endeavours to prevent suffering
by promoting and strengthening humanitarian law and universal humanitarianprinciples. Established in 1863, the ICRC is at the origin of the International RedCross and Red Crescent Movement.
Acknowledgements:
Jean Franois GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard Matagne
Joel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
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0868/002
09/200
6
200
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International Committee of the Red Cross
19 Avenue de la Paix1202 Geneva, Switzerland
T + 41 22 734 60 01 F + 41 22 733 20 57
E-mail: [email protected]
www.icrc.org
ICRC, September 2006
All photographs: ICRC/PRP
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Foror
T ICRC oro tcoo
Sinceitsinceptionin1979,theICRCsPhysicalRehabilitationProgrammehaspromotedtheuseotechnologythatisappropriatetothespeciccontextsinwhichtheorganizationoperates,i.e.,countriesaectedbywarandlow-incomeordevelopingcountries.
Tetechnologymustalsobetailoredtomeettheneedsothephysicallydisabledinthecountriesconcerned.
Tetechnologyadoptedmustthereorebe:
durable,comortable,easyorpatientstouseandmaintain; easyortechnicianstolearn,useandrepair; standardizedbutcompatiblewiththeclimateindierentregionsotheworld; low-costbutmodernandconsistentwithinternationallyacceptedstandards; easilyavailable.
Techoiceotechnologyisogreatimportanceorpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreerredtodevelopitsowntechniqueinsteadobuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.TecostothematerialsusedinICRCprostheticandorthoticdevices
islowerthanthatothematerialsusedinappliancesassembledromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanuacturedlocally.Intheearly1990stheICRCstartedtheprocessostandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,orthesakeoharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityoservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988orthemanuactureoprostheticsockets.Terstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponents
suchasvariousalignmentsystemswererstdevelopedinColombiaandgraduallyimproved.Inparallel,adurableoot,madeinitiallyopolypropyleneandEthylVinylAcetate(EVA),andnowopolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberoot.
In1998,aercareulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertoocusonpatientcareandtrainingopersonnelatcountrylevel.
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Ojctiv o t
TeICRCsManuacturingGuidelinesaredesignedtoprovidetheinormationnecessaryorproductionohigh-qualityassistivedevices.
Temainaimsotheseinormativemanualsareasollows:
opromoteandenhancestandardizationoICRCpolypropylenetechnology; oprovidesupportortrainingintheuseothistechnology; opromotegoodpractice.
Tisisanothersteporwardintheeorttoensurethatpatientshaveaccesstohigh-qualityservices.
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Itroctio
Teaimothisdocumentistodescribeamethodormanuacturingtrans-tibial () prosthesesusingtheICRCspolypropylenetechnologyasappliedinICRCprojectsworldwide.
Tecasting,recticationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsopracticeandarethereorenotdescribedintheseICRCmanuacturingguidelines.
ICRC P hysical Rehab i l i tat ion P rog ramme
For short and medium stump, adult
Te alignment system and oot components are available in adult and child sizes.
Raw maTeRIals and COmpOnenTs1
4Description:
Convexankle
woconcavecylinders
Convexdisc
Cylindricalcup
5 Flatsteelwasherandcountersunkheadbolt
6 SolidAnkleCushionHeel(SACH)oot
7 Hexagonalheadboltandlockwasher
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For long stump
Te alignment system and oot components are available only in adult size.
4PB(patellar-tendon-bearing)socketsecuredwithacususpension.Tesuspensioncanbeadjusted.
Incaseomedio-lateralinstabilityothekneeororastronghyperextension,athighcorsetwithsidebarsissuitable.
Tiscanbemadewithorwithoutasoliner.
Socket design
4Description:
Concaveankle
Convexdisc
Cylindricalcup
Flatsteelwasher
5 SolidAnkleCushionHeel(SACH)oot
6 CountersunkheadM10boltandthelockwasher
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measuRemenTs and sOFT sOCkeT manuFaCTuRe2
6PB-SC(supra-condylar)
Shouldbemadewithasoliner.
6PB-SCSP(supra-condylar,supra-patellar)
Mustbemadewithasoliner.
6Tepatientisassessed,aprescriptionismade,measurementsaretakenandmouldingandrecticationareperormedaccordingtobestP&Opractice.
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sot ir ctr
Manufacturing Guid el ines Trans-Tibial Prosthesis
4Measuretheplastermould.Notethe: smallestcircumerence; largestcircumerence; length.
6Drawatrapezoidonasheeto6mmEVAaccordingtothemeasurementstakenbutadding3cmtothelengthontheshortsideothetrapezoid.
CuttheEVAandskivethelateralandthedistalsides(about12mm).
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6Applyglueonbothskivedsidesandormacone.Keepthetrimmeddistalsideontheoutsideotheconeandleaveitreeoglue.
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Applytalcumpowderinsidetheconeandontheplastermodel.
Termoormingisdoneusingthevacuumpump,onaverticalsuctionhose.
HeattheEVAconeintheovenat120C.
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4Allowthesolinertocooldownorewminutes.
Removetheplasticbag.
Prepareapieceo6mmEVAtocoverthebottomedge.
Applygluetothetrimmededgeandthecovercap.
Heatthecapintheovenandmoulditonthesocket.
CutotheextraEVAandgrindtillsmooth.
Addpaddingabovethemedialcondyleandotherareasirequired.
Manufacturing Guid el ines Trans-Tibial Prosthesis
6PulltheEVAconeovertheplastermould,keepingthegluedlineontheposteriorside,untilthetrimmeddistalsidecoincideswiththetipotheplastermould.
Coverthemouldwithaplasticbag,closeitsecurelybelowthemouldwithanelasticstrapandswitchonthevacuumpump.
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4Lastly,coverthedistalpartwitha3mmor6mmEVAcapandgrindtillsmooth.
Manufacturing Guid el ines Trans-Tibial Prosthesis
TRans-TIbIal Cup alIgnmenT and s OCkeT manuFaCTuRe3
4Grindtheedgeothesocketcup.
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ait o t trtii c
4Fixthenailatthebottomothemould,wherethecupwillbeattached.
PlacethemouldontheCRalignmentjig;
alignaccordingtotheinstructionsontheuseothejig(separatemanual).Perormthealignmentinaccordancewiththemeasurementcard.Fixthecuptothesocketwithplaster.
4Fromthemiddleothecondyle,theplumbline
shouldpassabout1cminrontothecupaxis.
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mctr o t oct (4 oro)
mrt
4Whentheplasterhasset,smoothit.
4Add15cmtothemeasurement
takenatpatellalevel.
Manufacturing Guid el ines Trans-Tibial Prosthesis
4Coverthesolinerwithanylonorcottonstocking.Removethenyloncoveringthecup.
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4FixaroundpieceoEVA(12+6mm)withanailinsidetheopeningothecup.
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4Add15cmtothemeasurementtakenatthedistalpart.
4Add15cmtothemeasuredlengthothesocket.
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4Cutasheeto4mmPPcorrespondingtothesemeasurements.CleanthePPsheetandtheefonintheovenwiththinner.
Put the PP in the oven at 180C .
4Switchonthevacuumpump;drapethePParoundthesocket.
Weldingseamposition: orPPcosmetic:lateralormedial orEVAcosmetic:posterior
CutotheexcessPPwhileitis stillhot.
LeavethevacuumonuntilthePPcoolsdown.
Manufacturing Guid el ines Trans-Tibial Prosthesis
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6CutthePPaccordingtothetrimlines,removetheplasterwithoutdamagingthesocketlinerandPPsocket,andgrindtheweldingseamdownto3mm.
6Oncetheplasterisremoved,useascrewdrivertoremovethepieceoEVA.
6Grindthedistalpartandcheckthatthesuraceisfat.
Formaximumstrength,keepaminimumPPthicknesso2to3mmunderthecup.
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buIldIng up The pROsThesIs and benCh alIgnmenT4
st to oo:
Ankle-ootbuild-upandalignment;
Socketbuild-up;Adjustmentolengthandweldingoconcavecylinderbutt;Finalbenchalignment.
6Te oot, the convex ankle and the concave cylinder are attached together.
Te window in the concave cylinder must be anterior.
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aoot it
Anextra4mmplatemustbeattachedtotheconvexankle.DrilltwoholesasshownontheillustrationbelowandxthetwocomponentstogetherwithaPPweldingrod. Tis will preventbreakage o the oot bolt.
Coot
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prrtio or fxtio
Attachtheconcavecylinder(withtheopeninginront)totheootandtheconvexankle.
Teheelheightisadjustedaccordingtothepatientsshoe;theconcavecylinder must beperpendicular to the ground.
Teoothasaheelheighto10mm(maximumheelheight:15to20mm).
Te ankle alignment system allows antero-posterior movements (fexion, extension).
Tis alignment system is used to adjust the angulation o the prosthesis accordingto heel height.
In any event, the concave cylinder must remain perpendicular to the ground.
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6Teootisadjustedin5to8externalrotations.
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6Checkthealignmentonceagainwiththepatientsshoeontheoot.
6Tesocketisattachedtotheconcavecylinderwiththeconvexdiscinbetween.
6Teopeningintheconcavecylinderremainsinront.Tealignmentsystemisinneutralpositionorthersttting.
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4Adjustthelengthaccordingtothemeasurementstakenonthepatient.
Marktheconcavecylinder
andsawotheexcess.
Cuttheconcavecylinderatanangleo90.
4Setthetemperatureothemirrorwelderbetween185and200C.
6HoldtheconcavecylindersonthemirrorwelderuntilarollomeltedPPorms.
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6Careullybringthecylinderstogetherandapplyslightpressure.
Cocv cir corrct
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Cocv cir icorrct
soct it
Tesocketisconnectedtoaconcavecylinderwithaconvexdiskinbetween.Teconnectionissecuredbyacountersunkheadboltandfatwasherinsidethesocket,withthe-nutinsidetheconcavecylinder.
Shiingcanoccurinalldirections:anterior,posterior,medial,lateralandcombinedmovements,witharangeo10mminalldirections
atrior iti Iiti oitio potrior iti
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6Tealignmentsystemalsoallowsfexion,extension,abduction,adductionandrotation.
6BenchalignmentisperormedaccordingtoP&Opracticeandadjustedduringttingandduringthegaittrainingperiod.
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6Beorethecosmeticismade,allthecomponentsmustbeweldedtogether.
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pOlypROpylene COsmeTIC manuFaCTuRe5
TerearetwowaysomanuacturingaPPcosmetic.
5.1 Cotic it r rt o oct rov
ajtt o rt
6Drawalineollowingtheshapeotheoot,thendisassembletheoot.
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Minus
mm
Manufacturing Guid el ines Trans-Tibial Prosthesis
4Checkyourmarkandgrinditcareully.
Checkoncemoreagainsttheoot.
4Stickadhesivetapeontheootanddrawalinewithapermanentmarkeronthetopotheconvexankleandonthetape.
4Disassembletheootanddrawalineallaroundtheplate4mmromtheedge.
Grindtheedgecareully.
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4Checkagainwiththeoot.
Weldthetwoplatestogether,rstusingtheweldingirontomakeagrooveandthenweldingwiththehot-airweldinggun.
Grindagaincareully.
mctr o cotic
6Cutacrosstheprosthesisbelowthelevelothehamstringtendonsandremovetheupperpart.
4SkivethePPedgecareully.
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4Addplastertoshapetheshank.
4Reducethecircumerenceotheshankby3cmtoalloworthethicknessothe4mmPPsheet.
Smooththeplaster.
Leavetheankleedgeree oplasterorthenalwelding.
4Fixthe4mmPPreinorcementplateat
thepopliteallevelwith2nails.
4Drawanylonorcottonstockingovertheplaster.
Addtalcumpowder.
Heatthe4mmPPsheetintheovenat180C.
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4Glueornail5mmPPundertheankleplatetocompensateorretractionothePPaeropening.
6DrapethePPundervacuum.
6CutotheexcessPPattheweldingseam.Keepthevacuumonuntiltheplasticcoolsdown.
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4Grindtheposteriorseamdownto2to3mm.Inthreeplaces,leaveawideroverlapoPPorholdingtheprosthesisduringwelding.
4Opentheseamcareullywithanoscillatingsawtoavoidbreakage.
6RemovethePPshellromtheprosthesisandremovetheplaster.Cleantheprosthesisthoroughlytoensurethatnopiecesoplasterremain.Puttheprosthesisbackintotheshell.
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4HoldtheprosthesisinaparallelvicewithEVAorrubberprotectionbetweenthevicejawsandthecosmeticshell.Closethetwosideso
theposteriorseamwithlockgripsand/orothersuitabletools.
Beorewelding,makeV-shapedindentationsalongtheseamwithaweldingiron.
4Tenalweldingisdonewithahot-airweldinggunanda4mmPPweldingrod.
4Weldtheankletothe
shell.Aerwelding,careullyfattentheanklesurace.
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4Polishwitharaspand/orasharppieceoglass.
4
Attachthe4mmPPreinorcementtotheshellwithtubularrivets.
Telaststepistoxtheootontheprosthesis.
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5.2 Cotic it cot pp oct
ajtt o rt
6Drawalineollowingtheshapeotheoot,thendisassembletheoot.
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4Checkyourmarkandgrinditcareully.
Checkoncemoreagainsttheoot.
4Stickadhesivetapeontheootanddrawalinewithapermanentmarkeronthetopotheconvexankleandonthetape.
4Disassembletheootanddrawalineallaroundtheplate3mmromtheedge.
Grindtheedgecareully.
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4Checkagainwiththeoot.
Onceagoodthasbeenachieved,weldthetwoplatestogether:rstmakeagroovewiththeweldingironandthenweldwiththehot-airweldinggun.
Grindagaincareully.
4Roughenthesuraceothesocket.
4Covertheconcavecylinderswithadhesivetape.
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4Shapetheshankwithplaster.
4Drawanylonorcottonstockingovertheprosthesis.
4Glueornail5mmPPundertheankleplatetocompensateorshrinkageothePPaerthermoorming.
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6Drapeasheeto3mmPParoundthemouldundervacuum.
4Grindtheposteriorseamdownto2to3mm.Inthreeplaces,leaveawideroverlapoPPorholdingtheprosthesisduringwelding.
4Opentheseamcareullywithanoscillatingsawtoavoidbreakage.
4RemovethePPshellromtheprosthesisandremovetheplaster.Cleantheprosthesisthoroughlytoensurethatnopiecesoplasterremain.
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4HoldtheprosthesisinaparallelvicewithEVAorrubberprotectionbetweenthevicejawsandthecosmeticshell.Closethetwosideso
theposteriorseamwithlockgripsand/orothersuitabletools.
Beorewelding,makeV-shapedindentationsalongtheseamwithaweldingiron.
4Tenalweldingisdonewithahot-airweldinggunanda4mmPPweldingrod.
4Weldtheankletotheshell.Aerwelding,careully
fattentheanklesurace.
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6Grindtheseamdownto2to3mm.Polishwitharasporapieceoglass.
6Weldtheproximalpartotheprosthesis.
Telaststepistoxtheootbackontheprosthesis.Checkthefatnessotheankle.
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eVa COsmeTIC manuFaCTuRe6
ajtt o rt
6Drawalineollowingtheshapeotheoot,thendisassembletheoot.
4Checkyourmarkandgrinditcareully.
Checkoncemoreagainsttheoot.
4Stickadhesivetapeontheootanddraw
alinewithapermanentmarkeronthetopotheconvexankleandonthetape.
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4Dismantletheootanddrawalineallaroundtheplate,3mmromtheedge.
4Grindtheedgecareully.
4Roughenthesuraceothesocket.
For heavy patients, reinorce the concavecylinders with a 3 mm PP sheet.
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4GluelayersoEVAontheprosthesis.
4Shapetomatchthesoundleg.
LeavetheankleplatereeoEVAorthenalcosmetic.
Bearinmindtheactthatanadditionallayero3mmEVAwillcovertheentireprosthesis,andthatthiswillincreasethecircumerenceotheprosthesisbyabout1cm.Atthisstage,checkyourcircumerencesbycomparingthemwiththemeasurementsnotedonthepatientstechnicalcard,andreducethesizeby1cmallover.
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4Cutasheeto3mmEVAaccordingtothecircumerencesmeasured,butlongerthanthemeasurements.
Skivethesidethatwillbegluedontopotheoot.
SkiveonelongsideotheEVAsheetandapplygluetothatpart.
urntheEVAsheetover,andcoverthisreversesidewithglue.
4Applygluetotheentireprosthesis(excepttheoot).
Heatthe3mmEVAsheetintheovenat120Coraewsecondsuntilitbecomesveryfexible.DonotoverheattheEVAoryoumayaccidentallymakeprintmarksonitduringmanipulation.
akethe3mmEVAsheetoutotheovenand
glueitovertheprosthesis,startingbygluingtheskivededgealongtheposteriorsideotheprosthesis.
4Tenstartgluingthe3mmEVAsheetontheprosthesisbyrevolvingtheprosthesisonit,applyingconstanttensionontheEVAtoavoidairbubblesandolds.
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4TelaststepistoremovetheexcessEVAandtogrindtheseamandtheproximaltrimlineotheprosthesissmoothly.
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ICRC Code Description Specifcation Unit o MeasureTrans-tibial module, child
OCPOMODUTTC Countersunk head boltFlat washer, steelTrans-tibial cupConvex discConcave cylinder with M8 T-nutConvex ankle
M8 x 60 mmD40 x d10 x H2.5 mmD70 x H26 mm
dia. 22 mm
1 piece1 piece1 piece1 piece2 pieces1 piece
Rrc it o tri
Coot: Trtii o, ci
ICRC Code Description Specifcation Unit o Measure
Trans-tibial module, adult
OCPOMODUTTA Countersunk head boltFlat washer, steelTrans-tibial cupConvex disc
Concave cylinder with T-nut M8Convex ankle
M10 x 60 mmD44 x d15 x H3 mmD70 x H26 mm
dia. 25 mm
1 piece1 piece1 piece1 piece
2 pieces1 piece
Coot: Trtii o, t
Weight per unit of measurement: 285 grams Quantity per box: 25 sets Box size: L40 x l30 x H44 cm
Weight per unit of measurement: 490 grams Quantity per box: 25 sets Box size: L40 x l30 x H44 cm
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ICRC Code Description Specifcation Unit o Measure
Trans-tibial module, long stump prosthesis
OCPOMODUTTLA Flat washer, steelTrans-tibial cupConvex discConcave ankle
D44 x d15 x H3 mmD70 x H26 mm
1 piece1 piece1 piece1 piece
Coot: Trtii o, o t roti
Weight per unit of measurement: 130 grams Quantity per packet: 1 piece
ICRC Code Description Specifcation
Feet or prosthesis
OCPOFOOT... Foot 22 28 cm, left and right,olive and terra colours
Heel, 10 mm
When ordering feet from 22 to 28 cm, change the number in the ICRC code and description.4With all the adult feet a M10 bolt and a M10 lock washer are included.4Weight per unit: (size 25) 605 grams Quantity per box: 25 pcs. Box L40 x l30 x H44 cm
OCPOFOOT... Foot 14 -21 cm, left and right,olive and terra colours Heel, 10 mm
When ordering feet from 14 to 21 cm, change the number in the ICRC code and description.4With all child feet a M8 bolt and a M10 lock washer are included.4Weight per unit: (size 19) 340 grams. Quantity per packet: 1 pc.
Coot: Ft or roti
Manufacturing Guid el ines Trans-Tibial Prosthesis
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Designation Used or
Materials
POP bandage 15 cm Cast-taking
POP powder Positive mould
Contact glue Soft socket
Soap (demoulding agent) Positive mould
Talcum powder Thermoforming
Vaseline Cast-taking
Nails Positive mould
Colorant for plaster Positive mould
Cotton/nylon stockinet dia. 8 or 10 cm Cast taking and soft socket
Cotton stockinet or sock Stump sock
Welding rod PP dia. 4 mm Welding components
Polypropylene 4 mm Hard socket
EVA 3 mm Soft socketEVA 6 mm Soft socket
Polypropylene cosmetic
Polypropylene 3 or 4 mm Cosmetic shell
Welding rod dia. 4 mm Welding cosmetic shell
Plaster powder Cosmetic shape
Adhesive tape
Tubular rivets (2) Posterior reinforcement
EVA cosmetic
EVA 3 mm; 6 mm; 12 mm
Contact glue
pp, eVa otr co
ICRC P hysical Rehab i l i tat ion P rog ramme
poro t: 2000 x 1000
str ct o oro t or ori rot
Trtii oct
4
Trtii cotic
3 or 4
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral andindependent organization whose exclusively humanitarian mission is to protect thelives and dignity of victims of war and internal violence and to provide them withassistance. It directs and coordinates the international relief activities conductedby the Movement in situations of conict. It also endeavours to prevent suffering
by promoting and strengthening humanitarian law and universal humanitarianprinciples. Established in 1863, the ICRC is at the origin of the International RedCross and Red Crescent Movement.
Acknowledgements:
Jean Franois GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard Matagne
Joel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
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0868/002
09/200
6
200
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Physical Rehabilitation Programme
trans-Femoral Prosthesis
Manufacturing guidelines
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International Committee of the Red Cross
19 Avenue de la Paix1202 Geneva, Switzerland
T + 41 22 734 60 01 F + 41 22 733 20 57
E-mail: [email protected]
www.icrc.org
ICRC, September 2006
All photographs: ICRC/PRP
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Tb of cott
Foreword 2
Introduction 41.Rawmaterialsandcomponents 4
2.Measurementsandsocketmanuacture 5
2.1rans-emoralcupalignmentandsocketmanuacture 6
2.2otal-contactprosthesis 11
3.Buildinguptheprosthesisandbenchalignment 15
4.Polypropylenecosmeticmanuacture 28
5.EVAcosmeticmanuacture 38
Reerencelistomaterials 41
Manufacturing Guid el ines Trans-Femoral P rosthesis
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Foror
T ICRC oro tcoo
Sinceitsinceptionin1979,theICRCsPhysicalRehabilitationProgrammehaspromotedtheuseotechnologythatisappropriatetothespeciccontextsinwhichtheorganizationoperates,i.e.,countriesaectedbywarandlow-incomeordevelopingcountries.
Tetechnologymustalsobetailoredtomeettheneedsothephysicallydisabledinthecountriesconcerned.
Tetechnologyadoptedmustthereorebe:
durable,comortable,easyorpatientstouseandmaintain; easyortechnicianstolearn,useandrepair; standardizedbutcompatiblewiththeclimateindierentregionsotheworld; low-costbutmodernandconsistentwithinternationallyacceptedstandards; easilyavailable.
Techoiceotechnologyisogreatimportanceorpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreerredtodevelopitsowntechniqueinsteadobuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.TecostothematerialsusedinICRCprostheticandorthoticdevices
islowerthanthatothematerialsusedinappliancesassembledromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanuacturedlocally.Intheearly1990stheICRCstartedtheprocessostandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,orthesakeoharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityoservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988orthemanuactureoprostheticsockets.Terstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponents
suchasvariousalignmentsystemswererstdevelopedinColombiaandgraduallyimproved.Inparallel,adurableoot,madeinitiallyopolypropyleneandEthylVinylAcetate(EVA),andnowopolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberoot.
In1998,aercareulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertoocusonpatientcareandtrainingopersonnelatcountrylevel.
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Objctiv of t
TeICRCsManuacturingGuidelinesaredesignedtoprovidetheinormationnecessaryorproductionohigh-qualityassistivedevices.
Temainaimsotheseinormativemanualsareasollows:
opromoteandenhancestandardizationoICRCpolypropylenetechnology; oprovidesupportortrainingintheuseothistechnology; opromotegoodpractice.
Tisisanothersteporwardintheeorttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRC
AssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Itroctio
Teaimothisdocumentistodescribeamethodormanuacturingtr-fr (F) rthusingtheICRCspolypropylenetechnologyasappliedatthePhysicalRehabilitationCentrein
AddisAbaba.
Tecasting,recticationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsopracticeandarethereorenotdescribedintheseICRCmanuacturingguidelines.
ICRC P hysical Rehab i l i tat ion P rog ramme
rans-emoralkitsareavailableinadultandchildsizes.
6Contentsothekit:
SolidAnkleCushionHeel(SACH)oot
Hexagonal-headboltandlockwasher Convexankle Concavecylinderandpin5 Setowashers,nutandbolt6 Convexdisc7 Conicalcup8 rans-emoralcup9 Kneeshell
Raw maTeRIals and COmpOnenTs1
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at, rt cti
measuRemenTs and sOCke T manuFaCTuRe2
4Tepatientisassessed,aprescriptionis
madeandmeasurementsaretakeninaccordancewithbestP&Opractice.
4AnegativecastistakeninaccordancewithusualP&Opractice.
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2.1 Tr-for c it oct fctr
4Temouldislledtoproducethepositive,whichisrectiedaccordingtothemeasurementstaken.
4Chamertheedgeothe
trans-emoralcup.
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ait of t tr-for c
4Coverthemouldwithnylon.
Fixthenailatthebottomothemould,wherethecupwillbeattached.
PlacetheFmouldontheCRalignmentjig;alignaccordingtotheinstructionsontheuseothejig(separatemanual).Makethealignmentinaccordancewiththemeasurementcard.FixthecuptothesocketwithplasteroParis(POP).
4AddapieceoEVAatthedistalparto
thecup.
TiswillpreventthePPrombeingdrawninduringsuction.
Itwillalsoacilitateopening.
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4Cutasheeto5mmPPaccordingtothemeasurements(add5cmtothecircumerenceand10-15cmtothelength).
LeavethePPintheovenataround
180orabout20minutes.
DrapethePPonthemouldandopenthevacuumsuction.
ICRC P hysical Rehab i l i tat ion P rog ramme
4CutotheexcessPP.
LeavethevacuumonuntilthePPcoolsdown.
4Waitatleast6hoursbeoreopening.
Drawthetrimlineontheproximalpartothesocket.
UsetheoscillatingsawtocutthePP.
Removetheplaster.
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4GrindthedistalpartothecupdowntotheEVApad.
UseascrewdrivertoremovetheEVA.
4Grindthedistalpartuntilitisfat. DonotremoveallthePP.
4Checkthatthesuraceisfat.
4Grindthedistalpartuntilitisfat.
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4Grindthesocketalongthetrimlineswiththerouter.
4Useasharppieceoglasstosmooththeedgeothesocket.
4Usingaconicaldrill,maketheholeorthecottonstockingororthesuctionvalve.
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6Positionthesuctionvalvemedio-laterallyanddistallytotheplastermould.Usethesuctionvalveringtoshapetheplaster.ReducethediameterotheplastertoalloworthethicknessoPPused(4or5mm).Smoothitnicelyandbreaktheedge.(see2.1,page6).
2.2 Tot-cotct roti
Terearetwowaysomanuacturingatotal-contacttrans-emoralsocket:
1.BythesameprocedureasoraconventionalF;
2.ByweldingtheconicalcupdirectlyunderthePPsocket.
Manufacturing Guid el ines Trans-Femoral P rosthesis
4Coverthemouldwithanylonstocking.
Fixthecupwithplasterinthe
usualway.
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3
12 6
3
Duringthersttting,glueapieceoEVAinsidethecupinordertoavoidairleakage.
Gluea12mmanda6mmpieceoEVAinsidethecup.Finally,usea3mmpiecetocoverthecupandthesidesothecup.
ICRC P hysical Rehab i l i tat ion P rog ramme
6Materialneededornishing.
6Gluethe12mmand6mmEVAdiscsinsidethecup.
6Lastly,gluethe3mmEVAallaroundthecup.
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4Drillaholeaccordingtothediameterothesuctionvalve.
Manufacturing Guid el ines Trans-Femoral P rosthesis
4Smooththeedgewithasharppieceoglass.
4estthesuctionvalveandcheckbyaddingwaterinsidethesocket.
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4Itheconicalcupisused,itmustbeadjustedtothesocketinaccordancewiththealignment.
Usetheweldingirontomakeagroovebetweenthesocketandtheconicalcup.
4Usethehot-airweldingguntoweldthecuptothesocket.
Tishastobedoneverycareullytoavoidbreakageduringthersttting.
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6Componentsfr 6 k ic y.
a-foot it
Anextra4mmplatemustbeattachedtotheconvexankle.(Fr 6 k ic y.)
DrilltwoholesasshownontheillustrationbelowandxthetwocomponentstogetherwithaPP
weldingrod.(Fr 6 k ic y.)
Ti wi rvt brkg f th ft bt.
Manufacturing Guid el ines Trans-Femoral P rosthesis
T bii- bc it roc t to foo
Ankle-ootalignment
Socketalignment Adjustmentolength Weldingocylinders Alignmentonishedprosthesis
6Preparationbeorexation fr 6 k ic y.
BuIldIng up The pROsThesIs and BenCh alIgnmenT3
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6Formaximumstrengthotheassembly,theopeningotheconcavecylindermustbeinront,andthereinorcementbarattheback.
ICRC P hysical Rehab i l i tat ion P rog ramme
6Fixationprocedure.
6Finalresultfr 6 k ic y.
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Teanklealignmentsystemallowsdorsalandplantarfexion,medio-lateralmovementssothattheprosthesiscanbeadjustedtotheheelheightotheshoe.
Tealignmentcanbeadjustedoraheelheightobetween0mmand20mm,butaheelheighto10mmisrecommended.
Teheelheightisadjustedaccordingtothepatientsshoe;theconcavecylinder ut bricur t th gru.
Manufacturing Guid el ines Trans-Femoral P rosthesis
4Teootisadjustedinexternalrotationso5.
4Checkthealignmentonceagainwiththepatientsshoeontheoot.
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4
ranserthismeasurementromtheootuptothemechanicalknee-jointaxis.
ICRC P hysical Rehab i l i tat ion P rog ramme
k--foot it
6Samemeasurement.
4Temeasurementtakenonthepatientmustberomthemedialtibialplateauplus1.5to2cmtotheground.
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4Drawalinewithamarkeraccordingtothemeasurementtaken.
Makeanothermark9cmromtherst.Tiscorrespondstothebottomotheconcavecylinderminus1cm.
4Usethepipecuttertomakethecut.
Smooththeedges.
4Payspecialattentiontotherotationotheknee-jointwiththeoot.
Heatthedistalpartothepipewiththe
hot-airweldinggun.
Usearubbermallettoinserttheknee-jointintotheconcavecylinderasarasthemark.
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soct bc it
lt jtt for or t t
Tesocketisconnectedtotheconicalcup(aerlengthadjustment)withaconvexdiscinbetween.Teconicalcupisweldeddirectlyontopothekneejoint.Teconvexdiscallowsabduction,
adduction,fexion,extensionandshiinginalldirections.
6Checkthealignmentandadjusttheconicalcupaccordingtothemeasurementstaken.
C oi i frot
CORReCT
C oi t bc
InCORReCT
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6Teorcepatternsonheelstrikeareasshownintheseillustrations.Breakagescanhappeneasily.
6Makesuretheconicalcupremainshorizontalinbothplanesbeoreweldingit.Checkalsokneealignmentandootrotation.
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4Tetemperatureothemirrorshouldbebetween185and200C.
4Holdthecylinderonthemirrorwelderornomorethan5minutesuntilarollomeltedPPisormed.
Weldaccordingtothemarksandapplyslightpressure.
wi t cir
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lt jtt for ort t
1.Tesocketisconnectedtotheconicalcupwithaconvexdiscinbetween.2.Tesecondconicalcupisconnectedtotheknee-jointwithanotherconvexdiscinbetween.3.Oncetheheighthasbeenadjusted,theconicalcupscanbeweldedtogether.
Staticordynamicalignmentcanbedoneeitherabovetheknee-jointorbelowthesocket.
lt jtt for o t: p tttio to ii iio ( bo)
A 22mmorconvex/concaveplatesB 40mmminimumdistancebetweenconnectionsuraceandaxisotheknee
A=22mm(minimum)
B=40mm
Dimensionstobedetermined:
A deviceoradjustingalignment
B distancebetweenupperpartotheknee-jointandkneeaxis
A B
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med. la. an. pos. an. pos.
an. pos. an. pos. med. la.
Fi roti it
6ModularPPtechnologyallowsslidingandtiltingduringalignment.
ICRC P hysical Rehab i l i tat ion P rog ramme
ntr oitio Fxio extio
6Backwardoranteriorshiingispossible.Shiingcanalsooccurmediallyorlaterally.
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Bt fctr
Duringtherstttingwiththepatient,themeasurementorthebeltistakenromthegreattrochanter,aroundthewaistandabovetheoppositeiliaccrestasarasScarpastriangle.
Tebeltcanbeeitheraleatheroracottonstrap,xedwitha16mmbuckle.
Add15cmtothemeasurementtakenonthepatienttoalloworadjustmentduringtting.
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pOlypROpylene COsmeTIC manuFaCTuRe4
6Allcomponentshavetobeweldedtogether.
6Drilla5mmholeintheconcavecylinderandthepipe.
6Fixtheexpansionpin.
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4RemovetheexcessPPornishingattheankleplate.
4Drawalineollowingtheshapeotheoot.
4Disassembletheoot.
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6Checkyourmarkandgrinditcareuly.Checkoncemoreagainsttheoot.
4Stickadhesivetapeontheootandmakeamarkwithapermanentmarkeronthetopotheconvexankleandonthetape.
4Removetheootanddrawalineallaroundtheplate4mmromtheedge.
Grindtheedgecareully.
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4Checkagainwiththeoot.
Onceagoodthasbeenachieved,weldthetwoplatestogether:rstmakeagroovewiththeweldingironandthenweldwiththehot-airweldinggun.
Grindagaintoobtainasmoothnish.
6Forheavyandactivepatients,astripo3mmPPcanbedrapedaroundtheconicalcupandalignmentsystemorextrastrength.Useanelasticbandagetotightenitwell.
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4WhenthePPhascooleddown,grindtheedgesandweld.
4Protecttheknee-jointwithadhesivetape.
Grindthesocketwithsandpapertoroughenit.
FillthesocketwithPOPinordertoxthepipe.
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4Shapethesocketwithplasteraccordingtothemeasurement.
4Smooththeplasterandcoveritwithastocking.
4Drape4mmPParoundthesocketinthesamewayasortherstsocket.
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6OncethePPhascooleddown,removetheproximalpart.
Usetheoscillatingsawtoopentheseam.
Removetheplasterandcleanupthesocket.
rimtheshellproximallyanddistallyinlinewiththesocketandtheknee-joint.
Replacetheshellonthesocket.
Weldtheseam.
Weldtheproximaledge.
Weldtheshelltotheknee-joint.
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4Whentheweldingiscompleted,removetheexcessPP.
Grindtheseambetweentheshellandtheknee-joint.
Teseammustbeground
almostfushwiththesocket. Grindtheproximaledgeothesocket.
Tesethreepartsmustthenbepolished.
4Protectthepipeandtheknee-joint
withtape.
4ShapetheshankwithPOPanddrapeasheeto4mmPPoverit.
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4Opentheshellandremovetheplaster.
4Inserttheprosthesisintothecosmeticshell.
Determineandgrindthe
proximaltrimlineormaximumfexionotheknee-joint.
4Weldtheseamandtheankleconnection.
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4Grindandsmooththewelding.
6InsertanEVAwashercuttothesameshapeastheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.Tiswillalsopreventcreaking.
4
Fixtheknee-jointbackontotheshank.
Fixthebelt.
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eVa COsmeTIC manuFaCTuRe5
6RoughentheEVAbeoreapplyingittothePPsocket.GluelayersoEVAonthesocketandshapeit.Anallayero3mmEVAwillcovertheentireprosthesis,increasingthecircumerenceby1cm.
4Cutasheeto12mmEVAcorrespondingtothecircumerenceothewoodenorplastermodelshank.SkivebothsidesotheEVAandglue.
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4PlacethesheetoEVAintheovenatabout120untilitbecomesso,thenbendittoobtainaconicalshape.Addtalcumpowderinsidetheconeandputitbackintheoven.
4PulltheEVAconeoverthemodelshankandtightenitwithanelasticbandage,oruseavacuumsystem.
4Cuttheposteriorproximaledgetoallowfexionotheknee-joint.
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4i:ornishingpurposes,windatapearoundtheproximalaspectotheoottopreventdamagetotheootcosmeticduringgrindingotheEVA.
4Shapetheshankaccordingtothemeasurementstakenonthesoundleg.Tenglueitdistallyontopotheoot.
InsertanEVAwashercuttotheshapeotheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.
Fixtheshanktothesocket.Fixthebelt.
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Rfrc it of tri
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Designation Used for
Materials
POP bandage 15 cm Cast-taking
POP powder Positive mould
Contact glue Soft socket
Soap (demoulding agent) Positive mould
Talcum powder Thermoforming
Vaseline Cast-taking
Nails Positive mould
Colorant for plaster Positive mould
Cotton/nylon stockinet dia. 8 or 10 cm Cast-taking
Cotton stockinet or sock Stump sock
PP welding rod dia. 4 mm Welding components
Polypropylene 5 mm Hard socket
Polypropylene cosmeticPolypropylene 4 mm Cosmetic shell
PP welding rod dia. 4 mm Welding components
POP powder Cosmetic shape
Adhesive tape
EVA cosmetic
EVA 3 mm; 6 mm; 12 mm
Contact glue
pp, eVa otr cob
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0868/002
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6
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alignment Jig For
lower-limb Prosthetics
Physical Rehabilitation Programme
Manufacturing guidelines
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International Committee of the Red Cross
19 Avenue de la Paix1202 Geneva, Switzerland
T + 41 22 734 60 01 F + 41 22 733 20 57
E-mail: [email protected]
www.icrc.org
ICRC, September 2006
All photographs: ICRC/PRP
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Tb of cott
Foreword 2
Introduction 41.Useothealignmentjig 5
1.1Descriptionothejig 5
1.2Possiblemovementsorpositioningthepositiveinspace 6
2.Installationothejig 8
3.Choiceandlocationocentringaccessories 9
4.Someexamplesouse 11
4.1rans-tibialsockets 11
4.2rans-emoralsockets 13
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Forword
T ICRC poypropy tcooy
Sinceitsinceptionin1979,theICRCsPhysicalRehabilitationProgrammehaspromotedtheuseotechnologythatisappropriatetothespeciccontextsinwhichtheorganizationoperates,i.e.,countriesaectedbywarandlow-incomeordevelopingcountries.
Tetechnologymustalsobetailoredtomeettheneedsothephysicallydisabledinthecountriesconcerned.
Tetechnologyadoptedmustthereorebe:
durable,comortable,easyorpatientstouseandmaintain; easyortechnicianstolearn,useandrepair; standardizedbutcompatiblewiththeclimateindierentregionsotheworld; low-costbutmodernandconsistentwithinternationallyacceptedstandards; easilyavailable.
Techoiceotechnologyisogreatimportanceorpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreerredtodevelopitsowntechniqueinsteadobuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.TecostothematerialsusedinICRCprostheticandorthoticdevices
islowerthanthatothematerialsusedinappliancesassembledromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanuacturedlocally.Intheearly1990stheICRCstartedtheprocessostandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,orthesakeoharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityoservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988orthemanuactureoprostheticsockets.Terstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponents
suchasvariousalignmentsystemswererstdevelopedinColombiaandgraduallyimproved.Inparallel,adurableoot,madeinitiallyopolypropyleneandEthylVinylAcetate(EVA),andnowopolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberoot.
In1998,aercareulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertoocusonpatientcareandtrainingopersonnelatcountrylevel.
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Obctiv of t u
TeICRCsManuacturingGuidelinesaredesignedtoprovidetheinormationnecessaryorproductionohigh-qualityassistivedevices.
Temainaimsotheseinormativemanualsareasollows:
opromoteandenhancestandardizationoICRCpolypropylenetechnology; oprovidesupportortrainingintheuseothistechnology; opromotegoodpractice.
Tisisanothersteporwardintheeorttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRC
AssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Itroductio
Everymanuacturingtechniquehasitsownspecicrequirements.TetechniquebasedontheuseopolypropylenewhichhasbeendevelopedbytheICRCsphysicalrehabilitationprogrammeisalso
subjecttothisrule;itmustcombinequality,easeouseandlowcost.
Tecomponentsortrans-tibial()andtrans-emoral(F)prosthesesproducedbyCREquipementsSA(CRE)alloworcertainangularandtranslationadjustments,butthesepossibilitiesarelimited: 20mmintranslationorsliding(2x10mmeachsideromtheneutralpoint) 20degreesintilting(2x10oneachsideothemedianaxis).
Itisadvisabletoretaintheseadjustmentpossibilitiesordynamicalignment,andtotakeintoaccounttheactthatstaticalignmentollowstheweight-bearingreerencelinestoachieveaneutralposition.
Inmostothetechniquesusedorsocketmanuacturewithpolypropylene,theconnectioncomponent,calledthecup,isincludedinthesocketduringthethermoormingphase.Itisthelinkthatholdstheotherpartsotheprosthesistogether.UsingthistechniquemeansthatthealignmentmustbeadjustedBEFOREthesocketthermoormingprocess.
Anothertechniqueallowstheproductionoull-contactsockets.Faultypositioningotheconnectingcomponent(thesocketcup)duringweldingmakesalignmentdicultorimpossibletoachieve.
Particularattentionmustthereorebepaidtowhethertheconnectingcuporsocketcupisplacedonthepositivebeoreoraerthethermoormingphase.
AspecialtoolhasbeendesignedandmanuacturedbytheICRCandCREtohelpprostheticandorthotic(P&O)technicianscompletethesealignmentphaseseasilyandwiththerequiredprecision.
Tistoolisthealignmentjig.
Obctiv of ti docut
Tepurposeothisdocumentistodemonstratetherelevanceanduseulnessothealignmentjigor
obtaininghigh-qualityresults.
TealignmentprinciplesappliedarebasedoninternationalP&Ostandards.
Rrk
TisdocumentisnotatechnicalmanualonthemanuactureoandFprostheses.
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1.1 Dcriptio of t i
Tealignmentjigisastainlesssteelrameabout2metreshighand0.8metreswide.Itissturdyand
stable.
Use OF The alIgnmenT jIg1
Poitioi p Fitio p
6Tepurposeothejigistoacilitatethepositioninginspaceothepositiveplaster,andtoholdtheconnectioncup(orsocketcup)rmlyandpreciselyduringtheoperationtoxittotherectiedpositivewithplaster(orbywelding).
Obviously,thisxationphaseisindependentothetypeosocketused:theillustrationshowsprostheseswithandwithoutsosocket.
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4Inthecentreothejigtherearetwocomponentswhichallowthepositioninginspaceandimmobilizationotheplasterpositiveinrelationtothepositionotheconnectioncup.
Atthetop:theballandsocketjoint.Tisallows: suspensionandimmobilizationothepositive;
rotationaroundthepipeaxis; orward,backwardandlateralmovements.
Below:thetray.Tisimmobilizestheconnectingpart(cuporsocketcup).
Teheightothetrayisadjustable.Itisxedonaverticalaxis,whichrepresentsthelegpartotheutureprosthesis.
ohelpthetechnicianvisualizethecomponentpartsotheutureprosthesis,aprostheticootisxedtothelowerendothisaxis.
Tealignmentprinciplesare
independentoheight.
ICRC P hysical Rehab i l i tat ion P rog ramme
1.2 Poib ovt for poitioi t poitiv i pc
4Longitudinalmovements.
4Lateralmovements.
4Ballandsocketrotation.
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4Lockingolongitudinalmovements.
4Gradientothepipe.Tepipecandescribeaconeoabout30atthesummit
(about15aroundtheverticalline).
4Teballandsocketallowscorrectpositioningothepositiveevenwhenthepipeiswronglyplaced.
4Ballandsocketdetailsandblockingscrew.
Lockingorotationandgradientothepipecarrier.
Lockingolateralmovements.
ighteningothepipe.
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woprecautionsmustbetakenbeorestartingtousethejig:
Checkwithaspiritlevelthatthecentralbeamsupportingtheverticalaxis(whichinturn
supportsthetray)isperectlyhorizontal,andmakeanynecessaryadjustmentsbymeansotheadjustableeet.
Installplumblinesbeyondtherangeomovementsothepipecarrier.
Byestablishingrontalandsagittalplanes,theseplumblinesallowexactapplicationotheprinciplesoalignment.
InsTallaTIOn OF The jIg2
4Frontalandsagittalplanesareestablishedwithplumblines(4x)beyondthe
movementsothepipecarrier.
4Checkwithaspiritlevel
thatthecentralbeamisperectlyhorizontal;adjustbymeansoadjustableeet.
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(A)T try
ChOICe anD lOCaTIOn OF CenTRIng aCCessORIes3
4Tetrayhas3holesM8.
Teholesituated2cmromthecentreisusedoradultFalignment
Tecentralholeisusedoradultandchild.
Teholesituated1cmromthecentreisusedorchildF.
WhenusedoradultF,thepositivesagittalplanisperpendiculartothecentralbeam,andwhenusedorchildF,themainlineothisbeamisthesameasthepositivesagittalplane.
Poitiv frot for dut iz
Positivefrontforchild-sizeBK
(B)Productio by of t cup (u of t ctri cyidr)
Poitiv frot
Poitiv rr
6Adultandchildalignment. 6AdultFalignment.
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Poitiv frot
Poitiv rr
6Fchild-sizealignment. 6Teconnectingcuponthetray.
(C)Productio by of t ockt cup
Tesocketcupmakesitpossibletomanuactureull-contactsockets(withcontactontheentiresuraceothestump,includingtheextremity).
Teprinciplesarethesame;onlytheaccessoryisdierent.
6Teaccessoryorcentringthesocketcupispositionedorinthecentralhole.
6TesocketcupispositionedoradultF.
5Centralbeammainline.
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sOme examPles OF Use4
sockt witout tri cotct
Teconnectioncupisassembledwiththepositivebeorethesocketthermoormingoperation
(methodmostrequentlyused).
. TT sockets
(A) ait of ort TT poitiv (rit)
6Posteriorview:Tepictureistakenothepositivewithoutsosockettomaketheshapesandmarksothepositivemoreclearlyvisible.Tepresenceorabsenceoasosockethasnoeectonthealignmentprinciples.
Viw bfor oii Viw ftr oii
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6Lateralview:
Viw bfor oii Viw ftr oii
(B) ait of o TT poitiv (ft)
ltr viw bfor oii Potrior viw bfor oii
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. TF sockets
(A) Prtr to b obrvd btw t CRe k d t it i
a=22mm(minimum)
b=40mm
Dimensionstobedetermined:
a deviceoradjustingalignment
b distancebetweenupperpartothekneeandkneeaxis
a b
6Tereisa2cmgapbetweenthesocketxationscrewandthekneeaxistotakethefexumintoaccount.
6Tekneeaxisisonthesameverticallineasthepipe(thepartbelowtheknee).
Tesamepositioningeaturesareoundonthealignmentjig.
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(B) lo tup
6Itispossibletoadjustthedistanceromischiumtokneewhentheconnectioncupisbeingxedbycalculatingheightainadvanceaccordingtothedetailsgivenabove.
Potrior viw bfor oii sid viw ftr oii
a
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(C) sort tup
Full-contact sockets
Teconnectingelement(thesocketcupinthiscase)isassembledwiththesocketaerthethermoormingoperation.
Warning:Specialcaremustbetakenwhenthesocketcupisusedastheconnectingcomponentwiththecontactsocket,orthesaetyothepatient.Indeed,inordertostrengthentheweldingbetweensocketandcupaerthermoorming,thesocketmustbecareullyadjustedasshownintheillustrationabove.
Ten,toensurethepatientssaety: theweldingshouldbeperormedwithparticularcare;
thepatientshouldnotbelealoneduringthettingandrehabilitationphases; polypropylenemustbeusedornishingsoastoormanexoskeletonthatguaranteesthesolidityotheprosthesis.
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Tesocketcupiseasytouse: Alignthesocketaccordingtothepossibilitiesoeredbythejig. Installinthetraythecentringdevicedesignedorsocketcups. Cutthesocketcupatthedesiredlengthandgiveittheappropriateshape. Weldthesocketcuptothesocketlightlywithaweldingiron. Removetheassemblythusobtained.
Endwithcareulwelding.
(A) TT ockt
sort TT ockt (id viw) lo TT ockt (potrior viw)
sort TF ockt (potrior viw) lo TF ockt (id viw)
(B) TF ockt
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral andindependent organization whose exclusively humanitarian mission is to protect thelives and dignity of victims of war and internal violence and to provide them withassistance. It directs and coordinates the international relief activities conductedby the Movement in situations of conict. It also endeavours to prevent suffering
by promoting and strengthening humanitarian law and universal humanitarianprinciples. Established in 1863, the ICRC is at the origin of the International RedCross and Red Crescent Movement.
Acknowledgements:
Jean Franois GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard Matagne
Joel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
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