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8/9/2019 Prosthetics and Orthotics Manufacturing Guidelines: Upper limb Prosthetics: Trans-Humeral Prosthesis
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8/9/2019 Prosthetics and Orthotics Manufacturing Guidelines: Upper limb Prosthetics: Trans-Humeral Prosthesis
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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.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
Manuact uring Guid el ines Trans-Humeral P rost hesis
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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 t at 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 hOOk 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,leaveitalittlelongersothatitcanbereadjusted.
Checkwiththeamputeethatthecablecontrolsystemunctionsproperlyindierentarmpositions.
oopenthehook,thepatientmoveshisshoulderonthesoundside(oppositesideordoubleamputees)ortheprosthesisorward.
4
Oncetheharnesshasbeenadjustedsothattheamputeeeelscomortablewithit,sewthebeltconnectionandthexationontothewebbinghanger.
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4opreventraying,meltthebresattheendothebeltwithaweldingiron.
4Teharnessisconnectedtothewebbinghangerontheposteriorside,whiletheotherendisxed
totheanteriorwallwithatubularrivet.
Teelasticstrapenablestheamputeetoopenandclosetheworkinghook.
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6Otherharnessingsystems,suchasthoseproducedbytheOttoBockCompany,maybeused.
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FInIshed TRans-humeRal PROsThesIs10
4Nexttothehookorworkingring,acosmetichandorothertoolrequiredbythepatientmaybeattached(screwedon).
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ICRC Code DescriptionUnit ofmeasure
Quantity
MDREBANDP10
MDREBANDP12
Plaster bandages 10 cmorPlaster bandages 12 cm
According to stump dimension
OMIS Plaster o Paris According to cast dimension
OMIS Nails Each 4
OPLAEVAFERA03OPLAEVAFKIN03OPLAEVAFLIV03
EVA 3 mm, plastic sheet or other or extension tube Each 1, dimension according to TH socketextension length
OMIS Tubular nylon stocking, 60 or 80 mm or PP draping Each 1, length according to TH socket
OMIS Bicycle brake housing dummies with electric cable Each Length described in book cableattachments
OPLAPOLYCHOC04OPLAPOLYCHOC05
OPLAPOLYSKIN04OPLAPOLYSKIN05
OPLAPOLYLIV04OPLAPOLYLIV05
Polypropylene 4 or 5 mm according to patient size:Polypropylene 4 mm, terra brownPolypropylene 5 mm, terra brown
Polypropylene 4 mm, beigePolypropylene 5 mm, beige
Polypropylene 4 mm, olivePolypropylene 5 mm, olive
Each Dimension explained in PP drapingtechnique
OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03
Polypropylene 3 mm or cable attachment dummies:Polypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive
Each
OMIS Defnitive bicycle brake cable with housing Each 1, cut according to patient sizeOMIS Fixation or cable attachment on orearm:Countersunk head sel-tapping screws d1 = 3 mm,L = 10 mm
Each 4
OHDWRIVET081
Fixation or PP cable attachment on trans-emoral socketand harness:Tubular rivets 8 x 9 mm
Each 5
OMIS PP webbing hanger or other fxation method Each 1
OMIS
OCPOELBOHAR
Harness nylon (or other) belt (width 25 mm) with elasticstrap (width 25 mm)orHarness or upper limb prostheses
Each 1, length according to patient size
lit of otr 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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