Physical Rehabilitation Programmetrans-humeral Prosthesis

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Manufacturing guidelines

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: icrc.gva@icrc.orgwww.icrc.org© ICRC, September 2006All photographs: ICRC/PRP

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Table of contents

Foreword 2Introduction 41.Castingandrectification 52.Positioningofthesocketcupfortheelbowunit 63.Polypropylenedraping 74.Assembly 85.Makingthehookcableattachments 96.Polypropylenedrapingforcableattachment 117.Shapingthecableattachment 128.Fixationofthehookcableattachments 139.Shoulderharness 1410.Finishedtrans-humeralprosthesis 18Listofcomponents,CREquipmentsSA(CRE) 19Listofothermanufacturingmaterials 20

Manufac tur ing Guidel ines Trans-Humeral Prosthesis

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral 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.

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Introduction

Thisdocumentdescribesamethodforproductionoftrans-humeral prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysicalRehabilitationCentreinBattambang,Cambodia.

Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

CasTIng and ReCTIFICaTIOn1

4Patientassessment,castingandrectificationofpositivecastimpressionsareperformedinaccordancewithP&Ostandards.

4Alignmentlinesantero-posteriorandmedio-lateral(A-P,M-L)aredrawnonthepositivemouldforproperpositioningoftheelbowcup.Inmostcases,thiswillbealongthecentralaxisofthetrans-humeralstump.

Drivenailsintothedistalendofthecasttoensuregoodadherenceforthebuild-upoftheplasterextension.

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

POsITIOnIng OF The sOCkeT CuP FOR The elbOw unIT2

4MakeaconicalextensiontubeusingEVA,plasticsheetingorsomeothersuitablematerialandpositionitaccordingtothealignmentlinesfortheelbowcup.Tapetheconeinplaceandfillitwithplasteruptotheleveloftheproximalendoftheelbowcup.

Formeasurementsseefollowingparagraph.

4Prolongtheproximalalignmentlinesalongtheplasterextensioninordertofacilitatepositioningoftheelbowcup.

Themeasurementfromtheacromiontothelateralepicondyleofthesoundside,minusthedistancefromtheelbowaxistothedistalendoftheelbowcup,willdeterminethelengthofthetrans-humeralsocket.

Driveanailintothedistalpartofthebuild-uptoensuregoodadherenceofthecup,andfixthecupinproperalignmentwithwetplasterinaccordancewithP&Ostandards(useanalignmenttableifavailable).

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

POlyPROPylene dRaPIng3

4Measurementsforpolypropylenesheet:

Cupcircumference+2cm Acromioncircumference+5cm Lengthofplastercast+15cm

Thicknessofsheet:4mm

Heatthepolypropyleneinanovenforabout20minutesat180°C.

4Beforedrapingthepolypropylenesheet,pullastockingovertheplastermould.Cutitattheproximalpartoftheelbowcupandfixitwithcontactglue.Dustthestockingwithtalcumpowder.

4Drapethepolypropyleneovertheplastermodelandstickthesidestogetheralongthemedialsideofthesocket.Tightenthepolypropylenearoundthesuctionconeortubeusingabicycleinnertube,ropeorstocking,thenopenthevacuumvalve.

� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

assembly4

6Removetheplaster,shapethesockettrimlinesandgrindthemedialweldingseam.

Flattenthepolypropyleneonthedistalendoftheelbowcup.

Assembletheelbowunitandcuttheforearmaccordingtothemeasurement.Thelengthoftheforearm,includingthehook,shouldbe1to2cmshorterthanthesoundside.Fixthewristunitwith4panheadPhillipsframingscrews(8x3mm).

�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

4Forthehookcableattachments,duplicatetheoutsidedistalpartofthetrans-humeralsocketandtheforearmwithplasterbandages.Fillthetwonegativeswithplasterandsmooththem.

4Pullstockinetovertheplastermodels.

makIng The hOOk Cable aTTaChmenTs5

�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

4Onthearmmould,placeabicyclebrakecablehousing7cmabovethedistalendoftheelbowcupandcurvetheupperpartaccordingtothepositionoftheharness.

Ontheforearm,placetheproximalcablehousingdummylaterally,3cmfromtheelbowaxis,toallowfullflexionoftheforearm.Thedistalcablehousingisplacedontheanteriorpartoftheforearm,atleast5cmfromthewrist,toallowrotationofthehook.

4Fixthecablehousingdummiestothestockinetwithcontactglue.

Topreventthecablehousingsfrombeingflattenedwhendrapingthepolypropylene,insertanelectricwireinthem.

Itispossibletomakeseveralhookcableattachments(e.g.leftandright)onthesamemould.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

POlyPROPylene dRaPIng FOR Cable aTTaChmenT6

4Drapea3mmpolypropylenesheetoverthearmusingthesamemeasurementsanddrapingtechniquesasforthetrans-femoralsocket.

4Whenthepolypropylenehascooled,markthetrimlinesofthehookcableattachmentsandcutwithanoscillatingsaw.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

shaPIng The Cable aTTaChmenT7

6Cutandshapethepolypropylenecablefixationsandinsertthecablehousingintothechannels.

Drillholescorrespondingtothediameterofthetubularrivetsorscrews(seenextparagraph).

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

FIxaTIOn OF The hOOk Cable aTTaChmenTs8

4Thefinishedhookcableattachmentsareplacedinthesamepositionasontheplastermould.

Ontheforearmtheyarefixedwith

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

4Onthetrans-humeralsocket,thehookcableattachmentisalsoplacedinthesamepositionasontheplastermould.

Fixtheattachmentwithtubularrivets(8x9mm).

Shouldthepositionoftheattachmentshavetobechanged,warmthemwithaheatgunandmouldthemagainagainstthearmsocketorforearm.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

shOuldeR haRness9

6Insertthebicyclebrakecableintothehousing.Ontheproximalpart,fixawebbinghangerwithascrewclamp.Onthedistalpart,makealoopwiththecableandsecureitwithasmallmetaltube(clampsleeve),whichisflattened(pressed)aroundthecable.

6Thesimplesttypeofharnessforoperatingthehookisthe“figureofeight”suspension.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

4Foldthenylonbeltaroundtheoppositeshoulder.Theconnectionshouldbeadjustedinthemiddleoftheback(spine).

4Stapleorclamptheharnesstogether.Whencuttingthebelt,leaveitalittlelongersothatitcanbereadjusted.

Checkwiththeamputeethatthecablecontrolsystemfunctionsproperlyindifferentarmpositions.

Toopenthehook,thepatientmoveshisshoulderonthesoundside(oppositesidefordoubleamputees)ortheprosthesisforward.

4Oncetheharnesshasbeenadjustedsothattheamputeefeelscomfortablewithit,sewthebeltconnectionandthefixationontothewebbinghanger.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

4Topreventfraying,meltthefibresattheendofthebeltwithaweldingiron.

4Theharnessisconnectedtothewebbinghangerontheposteriorside,whiletheotherendisfixedtotheanteriorwallwithatubularrivet.

Theelasticstrapenablestheamputeetoopenandclosetheworkinghook.

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

6Otherharnessingsystems,suchasthoseproducedbytheOttoBockCompany,maybeused.

�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

FInIshed TRans-humeRal PROsThesIs10

4Nexttothehookorworkingring,acosmetichandorothertoolrequiredbythepatientmaybeattached(screwedon).

��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis

ICRC Code Description Unit of measure Quantity

OCPOELBOKIAOCPOELBOLIAOCPOELBOERA

*Elbow, adult *Elbow kits are available in three different colours. Choose ICRC code according to colour.**** Skin colour** Olive colour** Terra colour

One elbow kit comprises:• Elbow unit• Elbow cup with M6 T-nut• Rubber joint, D70 x d6 x H3 mm• PP wrist unit with M10 T-nut, dia. 45 mm• Pan head Phillips framing screws 8 x 3 mm for wrist unit

Kit

EachEachEachEachEach

1

11114

OCPOHOOKAL

OCPOHOOKAR

KORTHOOKSP

*Hook, adult, left, stainless steel, M10 threadAccording to side of amputation

*Hook, adult, right, stainless steel, M10 thread*According to side of amputation

Spare parts for hook:Rubber washer, D30x d10x H6 mmStainless steel spring

Each

Each

EachEach

1

1

1010

OCPOHOOKKRT *Working round ring tool, stainless steel with rubber washer*On request by amputee

Each 1

OCPOHANDERMLOCPOHANDERMROCPOHANDERWLOCPOHANDERWR

Terra colour:Hand, man, left, terra colourHand, man, right, terra colourHand, woman/child, left, terra colourHand woman/child, right, terra colour

EachEachEachEach

1111

OCPOHANDKIMLOCPOHANDKIMROCPOHANDKIWLOCPOHANDKIWR

Beige colour:Hand, man, left, beige colourHand, man, right, beige colourHand, woman/child, left, beige colourHand, woman/child, right, beige colour

EachEachEachEach

1111

OCPOHANDLIMLOCPOHANDLIMROCPOHANDLIWLOCPOHANDLIWR

Olive colour:Hand, man, left, olive colourHand, man, right, olive colourHand, woman/child, left, olive colourHand, woman/child, right, olive colour

EachEachEachEach

1111

list of components, CR equipments sa (CRe)

�0 ICRC Physical Rehabi l i tat ion Programme

ICRC Code Description Unit of measure Quantity

MDREBANDP10

MDREBANDP12

Plaster bandages 10 cmorPlaster bandages 12 cm

According to stump dimension

OMIS Plaster of Paris According to cast dimensionOMIS Nails Each 4OPLAEVAFERA03OPLAEVAFKIN03OPLAEVAFLIV03

EVA 3 mm, plastic sheet or other for extension tube Each 1, dimension according to TH socket extension length

OMIS Tubular nylon stocking, 60 or 80 mm for PP draping Each 1, length according to TH socketOMIS Bicycle brake housing dummies with electric cable Each Length described in book cable

attachments

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 draping technique

OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03

Polypropylene 3 mm for cable attachment dummies:Polypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive

Each

OMIS Definitive bicycle brake cable with housing Each 1, cut according to patient sizeOMIS Fixation for cable attachment on forearm:

Countersunk head self-tapping screws d1 = 3 mm, L = 10 mm

Each 4

OHDWRIVET081

Fixation for PP cable attachment on trans-femoral socket and harness: Tubular rivets 8 x 9 mm

Each 5

OMIS PP webbing hanger or other fixation method Each 1OMIS

OCPOELBOHAR

Harness nylon (or other) belt (width 25 mm) with elastic strap (width 25 mm)orHarness for upper limb prostheses

Each 1, length according to patient size

list of other manufacturing materials

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: icrc.gva@icrc.orgwww.icrc.org© ICRC, September 2006All photographs: ICRC/PRP

Physical Rehabilitation Programmeankle-Foot orthosis

Manufacturing guidelines

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