Prosthetics and Orthotics Manufacturing Guidelines - 1 ... · The ICRC’s “Manufacturing...
Transcript of Prosthetics and Orthotics Manufacturing Guidelines - 1 ... · The ICRC’s “Manufacturing...
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Physical Rehabilitation Programmetrans-Femoral Prosthesis
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Manufacturing guidelines
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.
Acknowledgements:
Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoestmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
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Table of contents
Foreword 2Introduction 41.Rawmaterialsandcomponents 42.Measurementsandsocketmanufacture 5
2.1Trans-femoralcupalignmentandsocketmanufacture 62.2Total-contactprosthesis 11
3.Buildinguptheprosthesisandbenchalignment 154.Polypropylenecosmeticmanufacture 285.EVAcosmeticmanufacture 38Referencelistofmaterials 41
Manufac tur ing Guidel ines Trans-Femoral Prosthesis
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� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
Foreword
The ICRC polypropylene technology
Sinceitsinceptionin1979,theICRC’sPhysicalRehabilitationProgrammehaspromotedtheuseoftechnologythatisappropriatetothespecificcontextsinwhichtheorganizationoperates,i.e.,countriesaffectedbywarandlow-incomeordevelopingcountries.
Thetechnologymustalsobetailoredtomeettheneedsofthephysicallydisabledinthecountriesconcerned.
Thetechnologyadoptedmustthereforebe:
• durable,comfortable,easyforpatientstouseandmaintain;• easyfortechnicianstolearn,useandrepair;• standardizedbutcompatiblewiththeclimateindifferentregionsoftheworld;• low-costbutmodernandconsistentwithinternationallyacceptedstandards;• easilyavailable.
Thechoiceoftechnologyisofgreatimportanceforpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreferredtodevelopitsowntechniqueinsteadofbuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.ThecostofthematerialsusedinICRCprostheticandorthoticdevicesislowerthanthatofthematerialsusedinappliancesassembledfromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanufacturedlocally.Intheearly1990stheICRCstartedtheprocessofstandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,forthesakeofharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityofservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988forthemanufactureofprostheticsockets.Thefirstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponentssuchasvariousalignmentsystemswerefirstdevelopedinColombiaandgraduallyimproved.Inparallel,adurablefoot,madeinitiallyofpolypropyleneandEthylVinylAcetate(EVA),andnowofpolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberfoot.
In1998,aftercarefulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertofocusonpatientcareandtrainingofpersonnelatcountrylevel.
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�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
Objective of the manuals
TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.
Themainaimsoftheseinformativemanualsareasfollows:
• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.
Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Introduction
Theaimofthisdocumentistodescribeamethodformanufacturingtrans-femoral (TF) prosthesesusingtheICRC’spolypropylenetechnologyasappliedatthePhysicalRehabilitationCentreinAddisAbaba.
Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
Trans-femoralkitsareavailableinadultandchildsizes.
6Contentsofthekit:
� SolidAnkleCushionHeel(SACH)foot� Hexagonal-headboltandlockwasher� Convexankle� Concavecylinderandpin5 Setofwashers,nutandbolt6 Convexdisc7 Conicalcup8 Trans-femoralcup9 Kneeshell
Raw maTeRIals and COmpOnenTs1
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5ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
assessment, measurements and casting
measuRemenTs and sOCkeT manuFaCTuRe2
4Thepatientisassessed,aprescriptionismadeandmeasurementsaretakeninaccordancewithbestP&Opractice.
4AnegativecastistakeninaccordancewithusualP&Opractice.
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2.1 Trans-femoral cup alignment and socket manufacture
4Themouldisfilledtoproducethepositive,whichisrectifiedaccordingtothemeasurementstaken.
4Chamfertheedgeofthetrans-femoralcup.
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alignment of the trans-femoral cup
4Coverthemouldwithnylon.
Fixthenailatthebottomofthemould,wherethecupwillbeattached.
PlacetheTFmouldontheCRalignmentjig;alignaccordingtotheinstructionsontheuseofthejig(separatemanual).Makethealignmentinaccordancewiththemeasurementcard.FixthecuptothesocketwithplasterofParis(POP).
4AddapieceofEVAatthedistalpartofthecup.
ThiswillpreventthePPfrombeingdrawninduringsuction.
Itwillalsofacilitateopening.
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4Cutasheetof5mmPPaccordingtothemeasurements(add5cmtothecircumferenceand10-15cmtothelength).
LeavethePPintheovenataround180°forabout20minutes.
DrapethePPonthemouldandopenthevacuumsuction.
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4CutofftheexcessPP.
LeavethevacuumonuntilthePPcoolsdown.
4Waitatleast6hoursbeforeopening.
Drawthetrimlineontheproximalpartofthesocket.
UsetheoscillatingsawtocutthePP.
Removetheplaster.
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4GrindthedistalpartofthecupdowntotheEVApad.
UseascrewdrivertoremovetheEVA.
4Grindthedistalpartuntilitisflat. DonotremoveallthePP.
4Checkthatthesurfaceisflat.
4Grindthedistalpartuntilitisflat.
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4Grindthesocketalongthetrimlineswiththerouter.
4Useasharppieceofglasstosmooththeedgeofthesocket.
4Usingaconicaldrill,maketheholeforthecottonstockingorforthesuctionvalve.
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6Positionthesuctionvalvemedio-laterallyanddistallytotheplastermould.Usethesuctionvalveringtoshapetheplaster.ReducethediameteroftheplastertoallowforthethicknessofPPused(4or5mm).Smoothitnicelyandbreaktheedge.(see2.1,page6).
2.2 Total-contact prosthesis
Therearetwowaysofmanufacturingatotal-contacttrans-femoralsocket:
1.BythesameprocedureasforaconventionalTF;
2.ByweldingtheconicalcupdirectlyunderthePPsocket.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4Coverthemouldwithanylonstocking.
Fixthecupwithplasterintheusualway.
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3 mm
12 mm6 mm
3 mm
Duringthefirstfitting,glueapieceofEVAinsidethecupinordertoavoidairleakage.
Gluea12mmanda6mmpieceofEVAinsidethecup.Finally,usea3mmpiecetocoverthecupandthesidesofthecup.
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6Materialneededforfinishing.
6Gluethe12mmand6mmEVAdiscsinsidethecup.
6Lastly,gluethe3mmEVAallaroundthecup.
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4Drillaholeaccordingtothediameterofthesuctionvalve.
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4Smooththeedgewithasharppieceofglass.
4Testthesuctionvalveandcheckbyaddingwaterinsidethesocket.
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4Iftheconicalcupisused,itmustbeadjustedtothesocketinaccordancewiththealignment.
Usetheweldingirontomakeagroovebetweenthesocketandtheconicalcup.
4Usethehot-airweldingguntoweldthecuptothesocket.
Thishastobedoneverycarefullytoavoidbreakageduringthefirstfitting.
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6Componentsfor 6 mm ankle disc only.
ankle-foot alignment
Anextra4mmplatemustbeattachedtotheconvexankle.(For 6 mm ankle disc only.)
DrilltwoholesasshownontheillustrationbelowandfixthetwocomponentstogetherwithaPPweldingrod.(For 6 mm ankle disc only.)
This will prevent breakage of the foot bolt.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
The building-up and bench alignment process – steps to follow
• Ankle-footalignment• Socketalignment• Adjustmentoflength• Weldingofcylinders• Alignmentoffinishedprosthesis
6Preparationbeforefixationfor 6 mm ankle disc only.
BuIldIng up The pROsThesIs and BenCh alIgnmenT3
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6Formaximumstrengthoftheassembly,theopeningoftheconcavecylindermustbeinfront,andthereinforcementbarattheback.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
6Fixationprocedure.
6Finalresultfor 6 mm ankle disc only.
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Theanklealignmentsystemallowsdorsalandplantarflexion,medio-lateralmovementssothattheprosthesiscanbeadjustedtotheheelheightoftheshoe.
Thealignmentcanbeadjustedforaheelheightofbetween0mmand20mm,butaheelheightof10mmisrecommended.
Theheelheightisadjustedaccordingtothepatient’sshoe;theconcavecylindermust be perpendicular to the ground.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4Thefootisadjustedinexternalrotationsof5°.
4Checkthealignmentonceagainwiththepatient’sshoeonthefoot.
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4Transferthismeasurementfromthefootuptothemechanicalknee-jointaxis.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
knee-ankle-foot alignment
6Samemeasurement.
4Themeasurementtakenonthepatientmustbefromthemedialtibialplateauplus1.5to2cmtotheground.
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4Drawalinewithamarkeraccordingtothemeasurementtaken.
Makeanothermark9cmfromthefirst.Thiscorrespondstothebottomoftheconcavecylinderminus1cm.
4Usethepipecuttertomakethecut.
Smooththeedges.
4Payspecialattentiontotherotationoftheknee-jointwiththefoot.
Heatthedistalpartofthepipewiththehot-airweldinggun.
Usearubbermallettoinserttheknee-jointintotheconcavecylinderasfarasthemark.
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socket and bench alignment
length adjustment for normal stump length
Thesocketisconnectedtotheconicalcup(afterlengthadjustment)withaconvexdiscinbetween.Theconicalcupisweldeddirectlyontopofthekneejoint.Theconvexdiscallowsabduction,adduction,flexion,extensionandshiftinginalldirections.
6Checkthealignmentandadjusttheconicalcupaccordingtothemeasurementstaken.
Cup opening in frontCORReCT
Cup opening at backInCORReCT
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6Theforcepatternsonheelstrikeareasshownintheseillustrations.Breakagescanhappeneasily.
6Makesuretheconicalcupremainshorizontalinbothplanesbeforeweldingit.Checkalsokneealignmentandfootrotation.
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4Thetemperatureofthemirrorshouldbebetween185°and200°C.
4Holdthecylinderonthemirrorwelderfornomorethan5minutesuntilarollofmeltedPPisformed.
Weldaccordingtothemarksandapplyslightpressure.
welding the cylinders
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length adjustment for a short stump
1.Thesocketisconnectedtotheconicalcupwithaconvexdiscinbetween.2.Thesecondconicalcupisconnectedtotheknee-jointwithanotherconvexdiscinbetween.3.Oncetheheighthasbeenadjusted,theconicalcupscanbeweldedtogether.
Staticordynamicalignmentcanbedoneeitherabovetheknee-jointorbelowthesocket.
length adjustment for a long stump: pay attention to minimum dimensions (see below)
A 22mmforconvex/concaveplatesB 40mmminimumdistancebetweenconnectionsurfaceandaxisoftheknee
A=22mm(minimum)
B=40mm
Dimensionstobedetermined:
A deviceforadjustingalignment
B distancebetweenupperpartoftheknee-jointandkneeaxis
A B
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med. laT. anT. posT. anT. posT.
anT. posT. anT. posT. med. laT.
Final prosthesis alignment
6ModularPPtechnologyallowsslidingandtiltingduringalignment.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
neutral position Flexion extension
6Backwardoranteriorshiftingispossible.Shiftingcanalsooccurmediallyorlaterally.
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Belt manufacture
Duringthefirstfittingwiththepatient,themeasurementforthebeltistakenfromthegreattrochanter,aroundthewaistandabovetheoppositeiliaccrestasfarasScarpa’striangle.
Thebeltcanbeeitheraleatheroracottonstrap,fixedwitha16mmbuckle.
Add15cmtothemeasurementtakenonthepatienttoallowforadjustmentduringfitting.
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pOlypROpylene COsmeTIC manuFaCTuRe4
6Allcomponentshavetobeweldedtogether.
6Drilla5mmholeintheconcavecylinderandthepipe.
6Fixtheexpansionpin.
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4RemovetheexcessPPforfinishingattheankleplate.
4Drawalinefollowingtheshapeofthefoot.
4Disassemblethefoot.
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Minus � mm
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6Checkyourmarkandgrinditcarefuly.Checkoncemoreagainstthefoot.
4Stickadhesivetapeonthefootandmakeamarkwithapermanentmarkeronthetopoftheconvexankleandonthetape.
4Removethefootanddrawalineallaroundtheplate4mmfromtheedge.
Grindtheedgecarefully.
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4Checkagainwiththefoot.
Onceagoodfithasbeenachieved,weldthetwoplatestogether:firstmakeagroovewiththeweldingironandthenweldwiththehot-airweldinggun.
Grindagaintoobtainasmoothfinish.
6Forheavyandactivepatients,astripof3mmPPcanbedrapedaroundtheconicalcupandalignmentsystemforextrastrength.Useanelasticbandagetotightenitwell.
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4WhenthePPhascooleddown,grindtheedgesandweld.
4Protecttheknee-jointwithadhesivetape.
Grindthesocketwithsandpapertoroughenit.
FillthesocketwithPOPinordertofixthepipe.
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4Shapethesocketwithplasteraccordingtothemeasurement.
4Smooththeplasterandcoveritwithastocking.
4Drape4mmPParoundthesocketinthesamewayasforthefirstsocket.
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�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
6OncethePPhascooleddown,removetheproximalpart.
Usetheoscillatingsawtoopentheseam.
Removetheplasterandcleanupthesocket.
Trimtheshellproximallyanddistallyinlinewiththesocketandtheknee-joint.
Replacetheshellonthesocket.
Weldtheseam.
Weldtheproximaledge.
Weldtheshelltotheknee-joint.
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4Whentheweldingiscompleted,removetheexcessPP.
• Grindtheseambetweentheshellandtheknee-joint.
• Theseammustbegroundalmostflushwiththesocket.
• Grindtheproximaledgeofthesocket.
Thesethreepartsmustthenbepolished.
4Protectthepipeandtheknee-jointwithtape.
4ShapetheshankwithPOPanddrapeasheetof4mmPPoverit.
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�6 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4Opentheshellandremovetheplaster.
4Inserttheprosthesisintothecosmeticshell.
Determineandgrindtheproximaltrimlineformaximumflexionoftheknee-joint.
4Weldtheseamandtheankleconnection.
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�7ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4Grindandsmooththewelding.
6InsertanEVAwashercuttothesameshapeastheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.Thiswillalsopreventcreaking.
4Fixtheknee-jointbackontotheshank.
Fixthebelt.
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�8 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
eVa COsmeTIC manuFaCTuRe5
6RoughentheEVAbeforeapplyingittothePPsocket.GluelayersofEVAonthesocketandshapeit.Afinallayerof3mmEVAwillcovertheentireprosthesis,increasingthecircumferenceby1cm.
4Cutasheetof12mmEVAcorrespondingtothecircumferenceofthewoodenorplastermodelshank.SkivebothsidesoftheEVAandglue.
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�9ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4PlacethesheetofEVAintheovenatabout120°untilitbecomessoft,thenbendittoobtainaconicalshape.Addtalcumpowderinsidetheconeandputitbackintheoven.
4PulltheEVAconeoverthemodelshankandtightenitwithanelasticbandage,oruseavacuumsystem.
4Cuttheposteriorproximaledgetoallowflexionoftheknee-joint.
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�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
4Tip:forfinishingpurposes,windatapearoundtheproximalaspectofthefoottopreventdamagetothefootcosmeticduringgrindingoftheEVA.
4Shapetheshankaccordingtothemeasurementstakenonthesoundleg.Thenglueitdistallyontopofthefoot.
InsertanEVAwashercuttotheshapeoftheshankabout10cmbelowtheknee-jointtokeepthecosmeticshankinplace.
Fixtheshanktothesocket.Fixthebelt.
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��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
Reference list of materials
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�7ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Femoral Prosthesis
Designation Used forMaterialsPOP bandage 15 cm Cast-takingPOP powder Positive mouldContact glue Soft socketSoap (demoulding agent) Positive mouldTalcum powder ThermoformingVaseline Cast-takingNails Positive mouldColorant for plaster Positive mouldCotton/nylon stockinet dia. 8 or 10 cm Cast-takingCotton stockinet or sock Stump sockPP welding rod dia. 4 mm Welding componentsPolypropylene 5 mm Hard socketPolypropylene cosmeticPolypropylene 4 mm Cosmetic shellPP welding rod dia. 4 mm Welding componentsPOP powder Cosmetic shapeAdhesive tapeEVA cosmeticEVA 3 mm; 6 mm; 12 mmContact glue
pp, eVa and other consumables
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MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.
Acknowledgements:
Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
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Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
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