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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.

    ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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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.

    ICRC P hysical Rehab i l i tat ion P rog ramme

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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.

    ICRC P hysical Rehab i l i tat ion P rog ramme

    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.

    ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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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.

    ICRC P hysical Rehab i l i tat ion P rog ramme

    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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    Minus

    mm

    Manufacturing Guid el ines Trans-Tibial Prosthesis

    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.

    ICRC P hysical Rehab i l i tat ion P rog ramme

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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.

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    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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    Minus

    mm

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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

    09/200

    6

    200

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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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