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    Physical Rehabilitation Programme

    trans-humeral Prosthesis

    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: icrc.gva@icrc.org

    www.icrc.org

    ICRC, September 2006

    All photographs: ICRC/PRP

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    T of cott

    Foreword 2

    Introduction 41.Castingandrectication 5

    2.Positioningothesocketcuportheelbowunit 6

    3.Polypropylenedraping 7

    4.Assembly 8

    5.Makingthehookcableattachments 9

    6.Polypropylenedrapingorcableattachment 11

    7.Shapingthecableattachment 12

    8.Fixationothehookcableattachments 13

    9.Shoulderharness 14

    10.Finishedtrans-humeralprosthesis 18

    Listocomponents,CREquipmentsSA(CRE) 19

    Listoothermanuacturingmaterials 20

    Manuacturing Guid el ines Trans-Humeral P rosthesis

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    4/48 ICRC P hysical Rehab i l i tat ion P rog ramme

    Foror

    T ICRC poprop 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

    Tisdocumentdescribesamethodorproductionotrans-humeral prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysical

    RehabilitationCentreinBattambang,Cambodia.

    Tecasting,recticationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsopracticeandarethereorenotdescribedintheseICRCmanuacturingguidelines.

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

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    CasTIng and ReCTIF ICaTIOn1

    4Patientassessment,castingandrecticationopositivecastimpressionsareperormedinaccordancewithP&O

    standards.

    4Alignmentlinesantero-posteriorandmedio-lateral(A-P,M-L)aredrawnonthepositivemouldorproperpositioningotheelbowcup.Inmostcases,thiswillbealongthecentralaxisothetrans-humeralstump.

    Drivenailsintothedistalendothecasttoensuregoodadherenceorthebuild-upotheplasterextension.

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    POsITIOnIng OF The sOCkeT CuP FOR The elbOw unIT2

    4MakeaconicalextensiontubeusingEVA,plasticsheetingorsomeothersuitablematerialandpositionitaccordingtothe

    alignmentlinesortheelbowcup.apetheconeinplaceandllitwithplasteruptothelevelotheproximalendotheelbowcup.

    Formeasurementsseeollowingparagraph.

    4Prolongtheproximalalignmentlinesalongtheplasterextensioninordertoacilitate

    positioningotheelbowcup.

    Temeasurementromtheacromiontothelateralepicondyleothesoundside,minusthedistanceromtheelbowaxistothedistalendotheelbowcup,willdeterminethelengthothetrans-humeralsocket.

    Driveanailintothedistalpartothebuild-uptoensuregoodadherenceothecup,andxthecupinproperalignmentwithwet

    plasterinaccordancewithP&Ostandards(useanalignmenttableiavailable).

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    POlyPROPylene d RaPIng3

    4

    Measurementsorpolypropylenesheet:

    Cupcircumerence+2cm Acromioncircumerence+5cm Lengthoplastercast+15cm

    Ticknessosheet:4mm

    Heatthepolypropyleneinanovenorabout20minutesat

    180C.

    4Beoredrapingthepolypropylenesheet,pullastockingovertheplastermould.Cutitatthe

    proximalpartotheelbowcupandxitwithcontactglue.Dustthestockingwithtalcumpowder.

    4Drapethepolypropyleneovertheplastermodelandstickthesidestogetheralongthemedial

    sideothesocket.ightenthepolypropylenearoundthesuctionconeortubeusingabicycleinnertube,ropeorstocking,thenopenthevacuumvalve.

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    assembly4

    6Removetheplaster,shapethesockettrimlinesandgrindthemedialweldingseam.

    Flattenthepolypropyleneonthedistalendotheelbowcup.

    Assembletheelbowunitandcuttheorearmaccordingtothemeasurement.Telengthotheorearm,includingthehook,shouldbe1to2cmshorterthanthesoundside.Fixthewristunitwith4panheadPhillipsramingscrews(8x3mm).

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    4Forthehookcableattachments,duplicatetheoutsidedistalpartothetrans-humeralsocketandtheorearmwithplasterbandages.Fillthetwo

    negativeswithplasterandsmooththem.

    4Pullstockinetovertheplastermodels.

    makIng The hOO k Cable aTTaChmenTs5

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    4Onthearmmould,placeabicyclebrakecablehousing7cmabovethedistalendotheelbowcupandcurvetheupperpartaccordingtothepositionotheharness.

    Ontheorearm,placetheproximalcablehousingdummylaterally,3cmromtheelbowaxis,toallowullfexionotheorearm.Tedistalcablehousingisplacedontheanteriorpartotheorearm,atleast5cmromthewrist,toallowrotationothehook.

    4Fixthecablehousingdummiestothestockinetwithcontactglue.

    opreventthecablehousingsrombeingfattenedwhendrapingthepolypropylene,insertanelectricwireinthem.

    Itispossibletomakeseveralhookcableattachments(e.g.leandright)onthesamemould.

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    POlyPROPylene dRaPIng FOR Cable aTTaChmenT6

    4Drapea3mmpolypropylenesheetoverthearmusingthesamemeasurementsanddraping

    techniquesasorthetrans-emoralsocket.

    4Whenthepolypropylenehascooled,markthetrimlineso

    thehookcableattachmentsandcutwithanoscillatingsaw.

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    shaPIng The Cable aTTaChmenT7

    6Cutandshapethepolypropylenecablexationsandinsertthecablehousingintothechannels.

    Drillholescorrespondingtothediameterothetubularrivetsorscrews(seenextparagraph).

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    FIxaTIOn OF The hOOk Cable aTTaChmenTs8

    4Tenishedhookcableattachmentsareplacedinthesamepositionasontheplastermould.

    Ontheorearmtheyarexedwithcountersunkheadsel-tappingscrews(d1=3mm,L=10mm).

    4Onthetrans-humeralsocket,thehookcableattachmentisalsoplacedinthesamepositionasontheplastermould.

    Fixtheattachmentwithtubularrivets(8x9mm).

    Shouldthepositionotheattachmentshavetobechanged,warmthemwithaheatgunandmouldthemagainagainstthearmsocketororearm.

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    shOuldeR haRness9

    6Insertthebicyclebrakecableintothehousing.Ontheproximalpart,xawebbinghangerwithascrewclamp.Onthedistalpart,makealoopwiththecableandsecureitwithasmallmetaltube(clampsleeve),whichisfattened(pressed)aroundthecable.

    6Tesimplesttypeoharnessoroperatingthehookisthegureoeightsuspension.

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    4Foldthenylonbeltaroundtheoppositeshoulder.Teconnectionshouldbeadjustedinthemiddleotheback(spine).

    4Stapleorclamptheharnesstogether.Whencuttingthebelt,leave