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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

�Manufac tur ing Guidel ines Trans-R adial Prosthesis

Table of contents

Foreword 2Introduction 41.Castingandrectification 42.Positioningthewrist 53.Polypropylenedrapingoffirstsocket 74.Productionofsecondsocket 95.Positioningofcablehousing 96.Polypropylenedrapingofsecondsocket 107.Fixationofcablehousing 128.Cablecontrolsystem(harness) 149.Fitting 17Listofcomponents,CREquipmentsSA(CRE) 19Listofothermanufacturingmaterials 20

Manufac tur ing Guidel ines Trans-R adial Prosthesis

� ICRC Physical Rehabi l i tat ion Programme

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.

�Manufac tur ing Guidel ines Trans-R adial Prosthesis

Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

� ICRC Physical Rehabi l i tat ion Programme

Introduction

Theaimofthisdocumentistodescribeamethodforproducingtrans-radial prostheses with interchangeable sockets,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysicalRehabilitationCentreinBattambang,Cambodia.

Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

CasTIng and ReCTIFICaTIOn1

4Patientassessment,castingandrectificationofpositivecastimpressionsareperformedinaccordancewithP&Ostandards.

4Alignmentlinesantero-posteriorandmedio-lateral(A-P,M-L)aredrawnonthepositivemouldforproperpositioningofthewrist.Inmostcasesthiswillbealongthecentralaxisofthetrans-radialstump.

Drivenailsintothedistalendofthecasttoensuregoodadherenceforthebuild-upoftheplasterextension.

�Manufac tur ing Guidel ines Trans-R adial Prosthesis

POsITIOnIng The wRIsT2

4MakeaconicalextensiontubeusingEVA,plasticsheetingorsomeothersuitablematerialandplaceitaccordingtothealignmentlinesforwristpositioning.Tapetheconeinplace.

Filltheextensionconewithplasterupto5mmhigherthanthelevelofthewrist,soastoleaveroomforshapingthecorrectanglesofthewrist.

4Prolongtheproximalalignmentlinesalongtheplasterextensioninordertofacilitatepositioningofthepolypropylenewrist.

� ICRC Physical Rehabi l i tat ion Programme

4Smoothandshapethebuild-upsothatitisperfectlyconical,otherwiseitwillbedifficulttoexchangethesocketsinthistechnique.

4Themeasurementfromtheolecranontotheradialstyloidprocessofthesoundsidewilldeterminethelengthoftheprosthesistothedistalendofthewristunit.

Thelengthoftheprosthesismaybe1to2cmshorterthanthesoundside,butneverlonger.

�

2

1

3

Manufac tur ing Guidel ines Trans-R adial Prosthesis

POlyPROPylene dRaPIng OF FIRsT sOCkeT3

4Measurementofpolypropylenesheet:

�Wristcircumference+2cm �Epicondylecircumference+4cm �Lengthofplastercast+15cm

Thickness3or4mm,dependingonpatient.

4Beforedrapingthepolypropylenesheet,pullastockingovertheplastermould.Cutitattheproximalpartofthewristandfixitwithcontactglue.Dustthestockingwithtalcumpowder.

4Heatthepolypropyleneinanovenforabout20minutesat180°C.

Drapethepolypropyleneovertheplastermodelandstickthesidestogetheralongtheposteriorside.Tightenthepolypropylenearoundthesuctionconeortubeusingabicycleinnertube,ropeorstocking,thenopenthevacuumvalve.

� ICRC Physical Rehabi l i tat ion Programme

4Usingscissorsoraknife,cutofftheleftoverpolypropyleneoftheweldingseamwhileitisstillhot.

Keepthevacuumonuntiltheplastichascooleddown.

4Removetheplaster,shapethesockettrimlinesandgrindtheposteriorweldingseam.

Drillahole(dia.20mm)onthemedial/distalsideforpullingthestumpsocket.

Flattenthepolypropyleneonthedistalendofthewrist.

Checkthesocketontheamputeeforcomfort,suspensionandlength.

�Manufac tur ing Guidel ines Trans-R adial Prosthesis

POsITIOnIng OF Cable hOusIng5

4Drawalinefromtheproximaltothedistalpartonthemid-anteriorofthesocket.The line must stop at least 5 cm from the wrist.Thisindicatesthepositionforthecablehousingdummy.

4Takeabicyclebrakecablewithhousing,cutitinaccordancewiththelengthofthelineandfixitonthestockingwithcontactglue.

PROduCTIOn OF seCOnd sOCkeT4

6Afterthefirstfitting,fillthesocketwithplasteragainandprepareitfordrapingthesecondsocket.Pull4cottonstockinettubesand1nylonstocking(toobtainasmoothsurface)overthefirstsocket.

�0 ICRC Physical Rehabi l i tat ion Programme

POlyPROPylene dRaPIng OF seCOnd sOCkeT6

4Heatastripofpolypropyleneandshapeittothesocket,1cmabovetheplannedtrimlinesofthe2ndsockettoavoidflaringatthetrimmededgesofthissocket.Thiswillalsoprotectthe1stsocketwhenthesecondoneisbeingcut.

4Drapea3mmpolypropylenesheetoverthesocket,usingthesamemeasurementsanddrapingtechniqueasforthe1stsocket.

Whenthepolypropyleneiscool,cutitonthestripwithanoscillatingsaworhacksaw.

4Removethe2ndpolypropylenesocketandtheplasterinsidethe1stsocket.

��Manufac tur ing Guidel ines Trans-R adial Prosthesis

6Thetrimlinesofthe2ndsocketshouldbeapproximately3cmdistaltothetrimlinesoftheanteriorsideofthe1stsocket,andshould“dip”6cmintheposteriortocreate“ears/wings”onthemedialandlateralsides.

Thiswillpreservesomeflexibilityforthe1stsocketandpreventrotationofthe2ndsocket.

Trimoffthedistalendbythewrist,leavingitflushwiththelengthofthe1stsocket.

�� ICRC Physical Rehabi l i tat ion Programme

FIxaTIOn OF Cable hOusIng7

4Removethecablehousingdummywithlongflatnosepliersoranawl.

4Cutanddrillopeningsintheendsofthechannelcreatedbythecablehousing.

��Manufac tur ing Guidel ines Trans-R adial Prosthesis

4Insertthedefinitivecablehousingandpushitinsidethechannelwitharivetingbar.

4Thecablehousingshouldextendatleast2cmoutsidethedistalchannelopeningtoprotectthecablewirefrombendingandbreaking,andtoallowenoughroomforthecabletoopenthehookfully.

�� ICRC Physical Rehabi l i tat ion Programme

4Themostsimpletypeofharnessforoperatingthehookisthe“figureofeight”suspension.

Stapleorclampanylonbelt(30mmwide)onthewebbinghanger.

Cable COnTROl sysTem (haRness)8

4Insertthebicyclebrakecableintothehousing.Ontheproximalpart,fixapolypropylenewebbinghangerwithascrewclamp.Onthedistalpart,makealoopwiththecableandsecureitwithasmallmetaltube(clampsleeve),whichisflattened(pressed)aroundthecable.

��Manufac tur ing Guidel ines Trans-R adial Prosthesis

4Foldthenylonbeltaroundtheoppositeshoulder.

Theconnectionshouldbeadjustedinthemiddleoftheback(spine).

4Stapleorclamptheharnesstogether.Whencuttingthebelt,leaveitalittlelongersothatitcanbereadjusted.

Checkwiththeamputeethatthecablecontrolsystemfunctionsproperlyindifferentarmpositions.

Toopenthehook,thepatientmoveshisshoulderonthesoundside(oppositesidefordoubleamputees)ortheprosthesisforward.

6Oncetheharnesshasbeenadjustedsothatamputeefeelscomfortablewithit,sewthebeltconnectionandthefixationontothewebbinghanger.

�� ICRC Physical Rehabi l i tat ion Programme

4Topreventfraying,meltthefibresattheendofthebeltwithaweldingiron.

4Finishedprosthesiswithinterchangeablesocket.

��Manufac tur ing Guidel ines Trans-R adial Prosthesis

FITTIng9

4Thefirstsocketcanbeusedwithacosmetichand,aworkingringorothertoolsnotrequiringthecablecontrolsystem.

4Checkwiththeamputeethatthesecondsocketslideseasilyoverthefirst.

�� ICRC Physical Rehabi l i tat ion Programme

4Teachthepatienthowtousetheinterchangeabletrans-radialsocketsandhowtoconnectandusetheharnessandthecable-operatedhook.

��Manufac tur ing Guidel ines Trans-R adial Prosthesis

ICRC Code Description Unit of measure Quantity

OCPOWRISKIAOCPOWRISLIAOCPOWRISERA

PP wrist unit, adult, with M10 T-nut (dia. 45 mm) and 4 pan head Phillips framing screws, 8 x 3 mm * Wrist units are available in 3 different colours. Choose ICRC code according to colour **** Beige colour** Olive colour** Terra colour

Each 1

OCPOHOOKAL

OCPOHOOKAR

KORTHOOKSP

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

Hook, adult, right, stainless steel, M10 threadAccording 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 ProgrammeICRC Physical Rehabi l i tat ion Programme

ICRC Code Description Unit of measure Quantity

For first TR socket:MDREBANDP10

MDREBANDP12

Plaster bandages 10 cmorPlaster bandages 12 cm

Each According to stump dimension

OMIS Plaster of Paris According to cast dimensionOMIS Nails Each 2OPLAEVAFERA03OPLAEVAFKIN03OPLAEVAFLIV03

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

OMIS Tubular nylon stocking, 60 or 80 mm for PP draping Each 1, length according to prosthesis

OPLAPOLYCHOC03OPLAPOLYCHOC04

OPLAPOLYSKIN03OPLAPOLYSKIN04

OPLAPOLYLIV03OPLAPOLYLIV04

Polypropylene 3 mm or 4 mm according to patient size:Polypropylene 3 mm, terra brownPolypropylene 4 mm, terra brown

Polypropylene 3 mm, beigePolypropylene 4 mm, beige

Polypropylene 3 mm, olivePolypropylene 4 mm, olive

Each Dimension explained in PP draping

For second TR socket:MDREBANDP10 Plaster bandage 10 cm Each According to first socket sizeOMIS Plaster of Paris According to first socket sizeODROSTOCOT60 Cotton stockinet 60 mm for PP draping Each 4 , length according to prosthesisOMIS Nylon stocking for PP draping Each 1, length according to prosthesisOMIS Bicycle brake cable housing dummy Each 1, cut according to socket length

OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03

Polypropylene 3 mm for trim line strip:Polypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive

Each 1, width: 20 mm, according to circumference

OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03

Polypropylene 3 mm for 2nd socketPolypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive

Each Dimensions explained in PP draping of 2nd socket

OMIS Definitive bicycle brake cable housing Each 1, cut according to socket lengthOMIS Bicycle brake cable Each 1, length according to patient sizeOMIS PP webbing hanger or other fixation method Each 1OSBOVSB24 Nylon (or Perlon) belt for harness, width 25 mm 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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