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Physical Rehabilitation Programme ANKLE-FOOT ORTHOSIS MANUFACTURING GUIDELINES

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Physical Rehabilitation Programmeankle-Foot orthosis

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 4Choosingbetweendifferentdesigns 4Castingandrectification 51.FlexibleAFO 6

1.1MouldingofEVA 61.2Orthosistrimline 61.3Vacuummouldingofthepolypropylene 61.4Preparationofthepolypropyleneshell 71.5Preparationofthestraps 81.6Initialfittingandfinishing 8

2.RigidAFO 82.1MouldingofEVA 82.2Orthosistrimline 92.3Plasticreinforcement 122.4Vacuummouldingofthepolypropylene 132.5Preparationofthepolypropyleneshell 142.6Proximalstrap 142.7Distalstrap 152.8Instepstrap 162.9Initialfittingandfinishing 18

3.AFOwithTamarackFlexureJointTM 183.1MouldingofEVA 183.2Orthosistrimline 183.3Plasticreinforcement 183.4InstallationofTamarackFlexureJointTM 193.5Vacuummouldingofthepolypropylene 193.6Preparationofthepolypropyleneshell 203.7Preparationofthestraps 223.8Initialfittingandfinishing 22

4.AFOanti-talus(anteriorshell) 224.1MouldingofEVA 224.2Orthosistrimline 234.3Plasticreinforcement 244.4Vacuummouldingofthepolypropylene 244.5Preparationofthepolypropyleneshell 254.6Preparationofthestraps 264.7Initialfitting 264.8Finishing 26

Listofmanufacturingmaterials 27

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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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Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Choosing between different designs

Withoutgoingintodetails,somefeaturesofdifferenttypesofAFOaresetoutbelowtoassistinthechoiceofdesign.

Flexible AFO• Dorsiflexionassistance• Poormedio-lateralstabilizationofthesubtalarjoint

Rigid AFO• Blocksanklemovements• Mediolateralstabilizationofthesubtalarjoint• Possibilityofcontrollingforefootadduction/abduction

AFO with Tamarack Flexure Joint TM

• Mediolateralstabilizationofthesubtalarjoint• Freeankledorsiflexion• Freeorrestrictedankleplantarflexion

AFO anti-talus• Blocksanklemovements.Particularlyefficientforpreventingankledorsiflexion• Poormediolateralstabilizationofthesubtalarjoint

Introduction

Theaimofthisdocumentistodescribeseveralmethodsformanufacturingankle-foot orthoses (AFO),workingwiththepolypropylenetechnologyusedattheICRC’sphysicalrehabilitationcentres.

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Casting and rectification

Patientassessment,castingandrectificationofpositivecastimpressionsareperformedinaccordancewithprostheticandorthotic(P&O)standards.

ForflexibleAFO,thecastcanbetakenwith5degreesofdorsiflexionsoastoprovideapreloadandensuresomespringaction.

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1.1 Moulding of EVA

AflexibleAFOdoesnotusuallyrequireanyEVA.However,incaseswhereitisnecessarytheproceduredescribedinsection2.1(page8)shouldbefollowed.

1.2 Orthosis trim line

Toachievethegoalofallowingdorsiflexionoftheanklewhilepreventingpassiveplantarflexion,thereareanumberofdesignoptions.

FlExIblE AFO1

4Markthetrimlineasfollows:

A Thetopishorizontal,2cmbelowthefibulahead.

B Attheankle,pass2cmbehindthetipofthemalleolitoallowflexionofthepolypropylene.

C Attheforefoot,leavethesidesofthetoesandtheheadofthemetatarsuscompletelyclearandpassthetrimlinebelowthem.This will allow the polypropylene to follow the movement of the metatarso-phalangeal joints.

Pullastockingovertheplastermodel.

1.3 Vacuum moulding of the polypropylene

Dustthestockingwithtalcumpowder.

Measurementofthepolypropylenesheet:

� Calfcircumference+10cm.� Instepcircumference+10cm.� Legandfootlength+10cm.(Seenextpicture.)

Thickness3mm,4mmor5mm,dependingonthepatient’sweight.

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Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheefficiencyoftheoven.

Drapethepolypropyleneovertheplastermodelandstickittogetheralongtheanteriorside.

Tightenthepolypropylenearoundthesuctionconebymeansofaropeorsomethingsimilar.

Openthevacuumvalve.

4CutofftheexcessPPwithapairofscissorswhileitisstillhot.

Keepthevacuumonuntilthepolypropylenecoolsdown.

1.4 Preparation of the polypropylene shell

Drawthetrimlineonthepolypropyleneasdescribedinsection1.2(page6).

Followingtheoutline,cuttheorthosiswithanoscillatingsaw.

Removetheplasticshellfromtheplastermodel.

RemovethestockingfrominsidetheAFO.

Grindtheorthosistrimlineandsmoothit.

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IfanEVAhasbeenmoulded,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

1.5 Preparation of the straps

Fortheproximalstrap,followtheproceduredescribedinsection2.6(page14).

Adistalstrapmightbeneeded,dependingonthecapacityofthepatient’sshoetoholdthefootinsidetheorthosis.Ifthisisneeded,followtheproceduredescribedinsection2.7(page15).

1.6 Initial fitting and finishing

IfEVAisused,glueitpartiallyinsidetheorthosis.

TheinitialfittingisperformedaccordingtoP&Ostandards.

Carryouttherequiredmodificationonthepolypropyleneandsmooththetrimline.

GluetheEVAcompletelyinsidethepolypropylene,cutoffthesurplusandsmooththetrimline.

RIgId AFO2

2.1 Moulding of EVA

EVA(6mm)maybemouldedpriortothedrapingofthepolypropylene,forthefollowingreasons:• toimprovecomfort;• topreventskinbreakageinpatientswithsensationloss;• fororthosesusedatnight.

Followtheproceduredescribedbelowor,ifthecasedoesnotrequireEVA,goontothenextsection.

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4Positiontheplastermodelwiththeforefootpointingdownwards.

MeasurementoftheEVAsheet:• width,instepcircumference;• length,thatoftheplastermodel

(leg+foot);• thickness,6mm.

HeattheEVAat120°for3to5minutes,dependingontheefficiencyoftheoven.

DrapetheEVAmanuallyovertheplastermodelandholditinplaceuntilithascooledcompletely.

4Cutofftheexcesswithacutterorapairofscissors.

StapletheEVAontothefrontoftheplastermodel.

2.2 Orthosis trim line

2.2.1 “Standard” trim line

4Markthetrimlineasfollows:

A Thetopmustbehorizontal,2cmbelowthefibulahead.

B Attheankle,passtheline1cmanteriortothetipofthemalleoli.

C Attheforefoot,leavethesidesofthetoesandtheheadofthemetatarsuscompletelyclearandpassthetrimlinebelowthem.This will allow the polypropylene to follow the movement of the metatarso-phalangeal joints.

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2.2.2 Trim line to correct forefoot adduction

Forefootadductioniscommonincasesofclubfoot.

4Markthetrimlineasfollows:

A Thetopmustbehorizontal,2cmbelowthefibulahead.

B Increasecoverageofthelateralmid-foot,passinginfrontofthecuboid,to enlarge the area of pressure.

C Attheforefoot,thelinemustbeproximaltothe5thmetatarsalhead.

D Decreasecoverageofthemedialmid-footatthenavicular/malleoli,to facilitate donning.

E Attheforefoot,coverthemedialsideofthemetatarsalheadandtoe,to correct forefoot adduction.

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2.2.3 Trim line to correct forefoot abduction

Forefootabductionisoftenseenincasesofcerebralpalsy.

4Markthetrimlineasfollows:

A Thetopmustbehorizontal,2cmbelowthefibulahead.

B Decreasecoverageatthelevelofthelateralmalleoli,to ease donning.

C Attheforefoot,thelinemustbedistaltothe5thmetatarsalhead,to avoid metatarsus abductus.

D Increasecoverageofthemedialmid-footatthelevelofthenavicular,to increase mid-foot support.

E Attheforefoot,thelinemustbeproximaltothe1stmetatarsalhead.

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2.3 Plastic reinforcement

TheAFOmayneedreinforcement,especiallyatanklelevel.Ifnecessary,useoneofthefollowingmethods;otherwisegoontothenextsection.

2.3.1 double layer of polypropylene

4Asecondlayerofpolypropylenecoveringtheankleandthefootismouldedatthesametimeasthemainlayer.

Cutapieceofpolypropylene:• thickness,3mm;• width,instepcircumference;• length,footlength+10cm

Grindthelast3cmattheproximalendtograduallyreducethethicknessofthepolypropylene.

4Thetwolayersareheatedatthesametime.

Thereinforcementisplacedontheplastermodel,thenthesecondlayerisvacuum-mouldedimmediatelytoobtainaperfectsealbetweenthetwo.

A double layer of polypropylene has the disadvantage of reducing flexibility of the forefoot in relation to the metatarso-phalangeal joint.

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2.3.2 Channels in the polypropylene

Thepresenceofchannelsintheplasticsignificantlyimprovesitsstrength.Thereareseveralwaysofmakingthesechannels.

4CuttwostripsofEVA:• thickness,6mm;• width,7mm;• length,15cm.

GrindbothdistalandproximalendstograduallyreducethethicknessoftheEVA.

Pullastockingovertheplastermodel.

Gluethestriplightlyontothestocking.

The more anterior the position of the channel, the more the AFO will resist dorsiflexion of the ankle.

Reinforcements prolonged along the side of the mid-foot increase the volume of the orthosis so that it may no longer fit into the patient’s shoe.

2.4 Vacuum moulding of the polypropylene

Ifthishasnotyetbeendone,pullastockingovertheplastermodel.For maximum efficiency, the EVA used to make channels in the polypropylene must not be covered with a stocking.

Followtheproceduredescribedinsection1.3(page6),takingintoaccountthepresenceorabsenceofadoublelayerofpolypropylene(section2.3.1,page12).

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2.6 Proximal strap

Useaready-madeVelcrostrap40mmwide,ormakeastrapwithPerlonwebbingorsomeotherstrongmaterial.

4Withalargetubularrivet,fixthebeltholdingthelooponthemedialside,1.5cmbelowtheproximaltrimline.

Theloopshouldbeplacedonthepolypropyleneandnotbeincontactwiththepatient’sleg.

2.5 Preparation of the polypropylene shell

Drawthetrimlineonthepolypropyleneasdescribedinsection2.2(page9).

Cuttheorthosiswithanoscillatingsaw,followingtheoutline.

Removetheplasticshellfromtheplastermodel.

RemovethestockingfrominsidetheAFO.

Grindtheorthosistrimlineandsmoothit.

IfEVAhasbeenmouldedbeforehand,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

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4Insertthebeltthroughthelooptomeasuretherequiredlength.

Fixthestrapwithalargetubularrivetonthelateralside.Makesurethestrapisperfectlyhorizontalbeforefixingit.

Coverthesurfaceofthestrapincontactwiththepatient’slegwith3mmEVA.

4Fixthestrapwithalargetubularrivetonthelateralside.Makesurethestrapisperfectlyhorizontalbeforefixingit.

Coverthesurfaceofthestrapincontactwiththepatient’slegwith3mmEVA.

2.7 distal strap

Youmustchoosebetweenadistalstrapandaninstepstrap.Thelatterhastheadvantageofholdingthecalcaneumfirmlyinsidetheorthosis(equinuscorrection).

UseaVelcrostrap25mmwide.

4Withalargetubularrivet,fixthebeltholdingthelooponthemedialside,4cmabovethemalleoli.

Theloopshouldbeplacedoverthepolypropyleneandnotbeincontactwiththepatient’sleg.

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2.8 Instep strap

UseaVelcrostrap25mmwide.

Twotechniquesarepresented,dependingonwhetherthebackofthefootisinaneutralpositionorneedsavalgus/varuscorrection.

2.8.1 Neutral position

4Withalargetubularrivet,fixthebeltholdingthelooponthemedialside,atanangleof45°passingthroughtheposteriordistaltipofthecalcaneum.

Theloopshouldbeplacedoverthepolypropyleneandnotbeincontactwiththepatient’sleg.

4Insertthebeltthroughthelooptomeasuretherequiredlength.

Fixthestrapwithalargetubularrivetonthelateralside,atthesameangleof45°.

Coverthesurfaceofthestrapincontact

withthepatient’slegwith3mmEVA.

2.8.2 Varus/valgus correction

Thestrapwillpassthroughaslotcutinthepolypropylene.

4Theslotiscutonthelateralsideforvaruscorrectionandonthemedialsideforvalguscorrection.

Markthepositionoftheslot40mmfromthebackofthefootandperpendiculartoalinedrawnatanangleof45°passingthroughtheposteriordistaltipofthecalcaneum.

Theslotshouldbe30mmlong.

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4Makeholesalongtheslotaxiswithadrillfittedwitha4mmbit.

4Withacutter,connecttheholeswitheachother.

Finally,smooththetrimlinewithafile.

4Theloopisplacedonthemedialsideforvaruscorrectionandonthelateralsideforvalguscorrection.

Fixthebeltholdingtheloopwithalargetubularrivet,atanangleof45°passingthroughtheposteriordistaltipofthecalcaneum.

Theloopshouldbeplacedoverthepolypropyleneandnotbeincontactwiththepatient’sleg.

4Insertthebeltthroughtheslotononesideandthroughtheloopontheothersidetomeasuretherequiredlength.

Fixthestrapwithalargetubularrivetjustoutsidetheslot.

Coverthesurfaceofthestrapincontactwiththepatient’slegwith3mmEVA.

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AFO wITh TAMARACk FlExuRE JOINT TM3

2.9 Initial fitting and finishing

IfEVAfoamisused,glueittemporarilyinsidetheorthosis.

TheinitialfittingisperformedinaccordancewithP&Ostandards.

Carryouttherequiredmodificationsonthepolypropyleneandsmooththetrimline.

GluetheEVAcompletelyinsidethepolypropylene,cutoffthesurplusandsmooththetrimline.

3.1 Moulding of EVA

Followtheproceduredescribedinsection2.1(page8),orgoontothenextsectionifEVAisnotrequired.

3.2 Orthosis trim line

Followtheproceduredescribedinsection2.2.1(page9).

3.3 Plastic reinforcement

Posteriorreinforcementforgreaterplantarflexioncontrolisrequiredwhentheorthosisisintendedtopreventplantarflexion(notfullydescribedbelow).

Followtheproceduredescribedbelow,orgoontothenextsectionifplantarflexionisleftfree.

AsecondlayerofpolypropyleneforpositioningattheleveloftheAchillestendonismouldedatthesametimeasthemainlayer.

4Cutapieceofpolypropylene:• thickness,5mm;• width,2cm;• length,7cm.

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4Firstthereinforcement(heatedatthesametimeasthepolypropylene)isplacedontheplastermodel,thenthesecondlayerisvacuum-mouldedimmediatelytoobtainaperfectsealbetweenthetwolayers.

4UsethemouldingdummiestoformasnuglyfittingcavityfortheTamarackFlexureJointTM.

Nailthemverticallyontotheplastermodelsothatthemidpointislocatedontheankleaxis.

3.4 Installation of Tamarack Flexure JointTM

Ontheplastermodel,markthepositionofthejointaxis:• laterally,attheapexofthemalleoli;• medially,slightlyposteriortothedistaltipofthemalleoli.

Makesurethatthejointsareatthesamelevelonbothsides.

3.5 Vacuum moulding of the polypropylene

Followtheproceduredescribedinsection1.3(page6),takingintoaccountthepresenceorabsenceofaposteriorreinforcement(section3.3,page18).

Pullastocking(cottonstockinetistoothick)overtheplastermodel.

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3.6 Preparation of the polypropylene shell

Drawthetrimlineonthepolypropyleneasexplainedinsection3.2(page18).

Cutonlythecontouroftheorthosiswithanoscillatingsaw.Donotcutalongtheseparationbetweenfootsectionandcalfsection.

Removetheplasticshellfromtheplastermodel.

ExtractthemouldingdummiesandthestockingfrominsidetheAFO.

4Drawtheseparationlinebetweenthefootsectionandthecalfsection:• Markthemiddleofthecavitiescreated

bythedummies.• Drawa“V”anteriortothemidlineof

eachcavity.Ensurethatthe“V”doesnotextendbackwardspastthecentreofthecavity.

4ForAFOwith plantar flexion control,drawahorizontallineposteriortothemarksjoiningthetwosides.

4ForAFOwith free plantar flexion,drawa“V”posteriortothemidlineofeachcavity.Ensurethatthe“V”doesnotextendforwardpastthecentreofthecavity.

Correct Incorrect

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4Drillholesatthedimplesleftbytheholesinthemouldingdummies:• 5mmforlargesize;• 4.5mmforsmallsize.

4Useathin-bladedsaw(1/16’’bladekerforless)toseparatethefootsectionfromthecalfsection.

Do not use an oscillating saw because too much material is lost along a ragged, wide cut line.

Smooththetrimlineedgewithahanddeburringtoolorapieceofglass.Do not grind the trim line because this will reduce flexure coverage and reduce the ability of the cavity to anchor and control the flexure effectively.

4InserttheTamarackFlexureJointTMandsecurewithmetalfastenersandanchoringscrews.

Dependingonthethicknessofthepolypropylene,itmaybenecessarytoadjustthelengthofthescrewsiftheendsprotrudeinsidetheAFO.

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3.7 Preparation of the straps

Fortheproximalstrap,followtheproceduredescribedinsection2.6(page14).

Insomecasesthepatientmightneedadistalstrap.Ifso,followtheproceduredescribedinsection2.7(page15).

3.8 Initial fitting and finishing

IfEVAfoamisused,glueittemporarilyinsidetheorthosis.

TheinitialfittingisperformedinaccordancewithP&Ostandards.

Carryouttherequiredmodificationsonthepolypropyleneandsmooththetrimline.

GluetheEVAcompletelyinsidethepolypropylene,cutofftheexcessandsmooththetrimline.

Gluetheflexureanchoringscrewswitharemovablethread-lockingcompound(Loctite).

AFO ANTI-TAluS (ANTERIOR ShEll)4

4.1 Moulding of EVA

EVA(6mm)maybemouldedpriortodrapingofthepolypropylene:• toimprovecomfort;• topreventskinbreakageforpatientswithsensationloss.

Do not cover the foot, to avoid an increase of volume which may prevent the patient from wearing normal shoes.

Followtheproceduredescribedbelow,orgoontothenextsectionifthecasedoesnotrequireEVA.

Positiontheplastermodelwiththeforefootpointingupwards.

4CutapieceofEVA:• width,calfcircumference;• length,leglength;• thickness,6mm.

HeattheEVAat120°for3to5minutes,dependingontheefficiencyoftheoven.

DrapetheEVAovertheplastermodelmanuallyandholditinplaceuntilithascooledcompletely.

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4Cutofftheexcesswithacutterorapairofscissors.

Grindthedistaltrimlinetograduallyreduceitsthickness.

StapletheEVAontothebackoftheplastermodel.

4Marktheorthosistrimlineasfollows:

A Thetopmustbehorizontal,2cmbelowthetibialtubercle.

B Ontheleg,1cmposteriortothemid-line.

C Ontheankle,atthetopofthemalleolitofacilitatedonning.

D Ontheforefoot,clearthesidesandtopofthetoesandtheheadofthemetatarsuscompletely,passingbelowthem.This will allow the polypropylene to follow the movement of the metatarso-phalangeal joints.

4.2 Orthosis trim line

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4.3 Plastic reinforcement

Thepresenceofchannelsintheplasticsignificantlyimprovesitsstrength.Thereareseveralwaysofmakingthesechannels.

4CuttwostripsofEVA:• thickness,6mm;• width,10mm;• length,20cm.

Grindbothdistalandproximalendstograduallyreducetheirthickness.

Gluethestripsontotheplastermodel,1cmanteriortothelateralandmediallongitudinalaxes.

Reinforcements prolonged along the side of the mid-foot increase the volume of the orthosis so that it may no longer fit into the patient’s shoe.

4.4 Vacuum moulding of the polypropylene

The procedure described below ensures uniform thickness of the polypropylene all over the orthosis. Do not try to make a single seam on the anterior side, because the creases gathering at the ankle will make it necessary to stretch the polypropylene too thinly.

Ifthishasnotyetbeendone,pullastockingovertheplastermodel.For maximum efficiency the EVA used to channel the polypropylene must not be covered with a stocking.

Dustthestockingwithtalcumpowder.

Measurementofthepolypropylenesheet:

� Calfcircumference+10cm.� Instepcircumference+10cm.� Legandfootlength+10cm.

PPthickness:4mmor5mm,dependingonthepatient’sweight.

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Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheefficiencyoftheoven.

Drapethepolypropyleneovertheplastermodelandstickittogetheralongtheposteriorsideandunderthefoot.

Tightenthepolypropylenearoundthesuctionconewitharopeorsomethingsimilar.

Openthevacuumvalve.

4Cutofftheexcesswithapairofscissorswhilethepolypropyleneisstillhot.

Keepthevacuumonuntilthepolypropylenecoolsdown.

4.5 Preparation of the polypropylene shell

Drawthetrimlineonthepolypropyleneasexplainedinsection4.2(page23).

Cuttheorthosiswithanoscillatingsaw,followingtheoutline.

Removetheplasticshellfromtheplastermodel.

RemovethestockingfrominsidetheAFO.

Grindtheorthosistrimlineandsmoothit.

IfEVAhasbeenmouldedbeforehand,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

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4.7 Initial fitting

IfEVAfoamisused,glueittemporarilyinsidetheorthosis.

TheinitialfittingisperformedinaccordancewithP&Ostandards.

4Itisoftennecessarytoflarethepolypropyleneattheposteriorpartoftheheelinordertofacilitatedonningandtoavoidpainfulcontactwiththeedgeoftheplastic.

4.6 Preparation of the straps

Fortheproximalstrap,followtheproceduredescribedinsection2.6(page14).

Insomecasesthepatientmightneedadistalstrap.Ifso,followtheproceduredescribedinsection2.7(page15).

4.8 Finishing

Carryouttherequiredmodificationsonthepolypropyleneandsmooththetrimline.

GluetheEVAinsidethepolypropylene,cutoffthesurplusandsmooththetrimline.

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ICRC Code Description Unit of measure Quantity

For negative and positive cast :ODROSTOCOT60 Tubular stockinet, 60 cm cm 70According to size:• MDREBANDP10• MDREBANDP12• MDREBANDP15

Plaster of Paris bandages10, 12 or 15 cm x 3 m

Piece 3

OTOOPLASPW40 Plaster of Paris powder Each As requiredFor EVA and plastic moulding :If required, according to colour:• OPLAEVAFERA06• OPLAEVAFLIV06• OPLAEVAFKIN06

EVA 6 mmTerra, olive or beige colour

Each As required

None Nylon stockinet Piece 1According to colour and thickness:• OPLAPOLYCHOC03• OPLAPOLYCHOC04• OPLAPOLYCHOC05• OPLAPOLYLIV03• OPLAPOLYLIV04• OPLAPOLYLIV05• OPLAPOLYSKIN03• OPLAPOLYSKIN04• OPLAPOLYSKIN05

HomopolymerTerra, olive or beige colour3, 4 or 5 mm thickness

Each As required

For the TAMARACK Flexure JointTM:According to size:• OCPOSOOTTAL• OCPOSOOTTAS

Large size (740L)Small size (740S)

Piece 1

EHDWGLUEL243 Glue, Loctite 243, blue, threadlock, 50-ml bottle As required 4For the proximal strap:OSBOSTRVP440 Strap, Velcro, PVC, with loop, brown, 400 x 40 mm Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2

orOSBOVSBO30 Strap, polyester, black, 40 mm cm 25None Strap, Velcro, 40 mm cm 20None Loop, 40 mm x 100 pieces Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2For distal/instep strap:OSBOSTRVP325 Strap, Velcro, PVC, with loop, brown, 300 mm x 25 mm Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2

orOSBOVSBO24 Strap, Perlon webbing, 25 mm cm 20None Strap, Velcro, 25 mm cm 15OSBOVSBO35 Loop, 25 mm x 100 pieces Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2

list of manufacturing materials

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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

0868

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Physical Rehabilitation Programme

Patellar tendon-bearing orthosis

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/002

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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 4Choosingbetweentwomethods 41.Castingandrectification 52.PTBOwithanterior-closingshell 6

2.1EVApreparationforincreasedweightrelief 62.2MouldingofEVA 72.3Orthosistrimline 82.4Plasticreinforcement 92.5Posteriorshell 102.6.Anteriorshell 122.7Preparationforinitialfitting 142.8Initialfittingandfinishing 17

3.PTBOwithposterior-closingshell 193.1EVApreparationforincreasedweightrelief 193.2MouldingofEVA 203.3Orthosistrimline 213.4Plasticreinforcement 223.5Anteriorshell 223.6Posteriorshell 253.7Preparationforinitialfitting 263.8Initialfittingandfinishing 27

Listofmanufacturingmaterials 28

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� 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.

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Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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� ICRC Physical Rehabi l i tat ion Programme

Choosing between two methods

Thefollowingindicationsmighthelpinmakingachoicebetweenthetwopossiblemethods.

Weight relief: partial or complete?

Accordingtotheprescriptionand/orthepathology,theorthosismustpartiallyorcompletelyrelievetheweightappliedontheleg.

Tothisend,alayerofEVAisaddedunderthefootpriortothedrapingofthepolypropylene.

Thefollowingfiguresgivearoughestimateofthedegreeofweightrelief:• NoEVA:70%oftheweightonthelegand30%ontheorthosis.• 3mmEVA:50%onthelegand50%ontheorthosis.• 6mmEVA:30%onthelegand70%ontheorthosis.• 12mmEVA:0%onthelegand100%ontheorthosis.

Introduction

Theaimofthisdocumentistodescribetwomethodsforproducingpatellar tendon-bearing (PTB) orthoses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheICRC’sphysicalrehabilitationcentres.

Anterior-closing shell Posterior-closing shellWeak at ankle level, especially for heavy patients or patients walking with ankle dorsiflexion.

Strong at ankle level, thus suitable for overweight patients or patients walking with ankle dorsiflexion.

Easy to fit into normal shoes.Sometime difficult to fit into normal shoes because of the volume of the orthosis at mid-foot.

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Patientassessment,castingandrectificationofpositivecastimpressionsareperformedinaccordancewithprostheticandorthotic(P&O)standards,takingintoaccountthefollowingpoints:• Theproximalpartismanufacturedlikeatrans-tibialprosthesisandensurestheweight-bearing

function.• Thedistalpartismanufacturedlikeanankle-footorthosis.• Theremustbelittleornoweightborneonthelegwhilethecastisbeingtaken.• Inthemethodinvolvingaposterior-closingshell,theEVAusedtoincreaseweightreliefisplaced

onlyundertheheel,soitaffects the position of the cast(seesection3.1,page19).

CasTIng and ReCTIFICaTIOn1

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2.1 eVa preparation for increased weight relief

Followtheproceduredescribedbelow,orgoontothenextsectionifthepatientdoesnotrequireadditionalweightrelief.

PTBO WITh anTeRIOR-ClOsIng shell2

4PlacetheplastermodelontheEVAsheetanddrawalinearoundit1cmwiderthanthefoot.

4Holdtheplastermodelinavice.

HeattheEVAat120°for3to5minutes,dependingonitsthicknessandontheefficiencyoftheoven.

PuttheEVAunderthefootandholditfirmlyinplacewithanelasticbandageforoneminute.

GrindtheedgeoftheEVAuntilitisperfectlyalignedwiththeshapeoftheplastermodel.

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6GluetheEVAundertheplastermodel.

2.2 Moulding of eVa

EVA(6mm)canbemouldedpriortodrapingofthepolypropylene:• toimprovecomfort;• topreventskinbreakageinpatientswithsensationloss.

Followtheproceduredescribedbelow,orgoontothenextsectionifEVAisnotrequired.

4Positiontheplastermodelwiththeforefootpointingdownwards.

CutapieceofEVA:• width,kneecircumference;• length,thelengthoftheplaster

model(leg+foot);• thickness,6mm.

HeattheEVAat120°for3to5minutes,dependingontheefficiencyoftheoven.

DrapetheEVAovertheplastermodelmanuallyandholditinplaceuntilithascompletelycooled.

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2.3 Orthosis trim line

4Cutofftheexcesswithacutterorapairofscissors.

StapletheEVAontothefrontoftheplastermodel.

4Marktheorthosistrimlineasfollows:

A Thetopmustbehorizontal,6cmabovethepatellatendongroove.

B Thepatellaandthehamstringtendonsareleftfree.

C Theshelloverlapstheantero-posteriormid-lineby1.5cm.

D Attheankle,keeptheline1cmanteriortothetopofthemalleoli.

E Theusualdistallimitoftheanteriorshellishorizontal,at1/3ofthelengthoftheleg,butmaybelongertoprovidegreaterprotection.

F Attheforefoot,clearthesidesofthetoesandtheheadofthemetatarsuscompletely,passingbeneaththem.This will allow the polypropylene to follow the movement of the metatarso-phalangeal joints.

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2.4 Plastic reinforcement

Theorthosismayneedreinforcement,especiallyatanklelevel.Ifthisisthecase,followoneoftheproceduresdescribedbelow;otherwisegoontothenextsection.

2.4.1 double layer of polypropylene

4Asecondlayerofpolypropylenecoveringtheankleandthefootismouldedatthesametimeasthemainlayer.

Cutapieceofpolypropylene:• thickness,3mm;• width,instepcircumference;• length,lengthoffoot+10cm.

Grindthelast3cmattheproximalendtograduallyreducethethicknessofthepolypropylene.

4Thetwolayersareheatedatthesametime.

Thereinforcementisplacedontheplastermodel,thenthesecondlayerisvacuum-mouldedimmediatelyafterwardstoobtainaperfectsealbetweenthetwolayers.

The double layer of polypropylene has the disadvantage of reducing flexibility of the forefoot in relation to the metatarso-phalangeal joint.

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2.4.2 lateral reinforcements (channels)

4CuttwobandsofEVA:• thickness,6mm;• width,7mm;• length,15cm.

Pullastockingovertheplastermodel.

Gluethebandlightlyontothestocking.

The more anterior the position of the channel, the more the device will resist dorsiflexion of the ankle.

Reinforcements prolonged along the side of the mid-foot increase the volume of the orthosis so that it may no longer fit into the patient’s shoe.

2.5 Posterior shell

2.5.1 Vacuum moulding of polypropylene

Ifthishasnotalreadybeendone,pullastockingovertheplastermodel.For maximum efficiency, the EVA used to channel the polypropylene must not be covered with a stocking.

Dustthestockingwithtalcumpowder.

Measurementofthepolypropylenesheet:

� Kneecircumference+10cm.� Instepcircumference+10cm.� Legandfootlength+10cm.

Thickness,4mmor5mm,dependingonthepatient’sweight.

2

1

3

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Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheefficiencyoftheoven.

Drapethepolypropyleneovertheplastermodelandstickittogetheralongtheanteriorside.

Tightenthepolypropylenearoundthesuctionconewitharopeorsomethingsimilar.

Openthevacuumvalve.

4Cutofftheexcesswithapairofscissorswhilethepolypropyleneisstillhot.

2.5.2 Preparation of the posterior shell

Drawthetrimlineonthepolypropyleneasexplainedinsection2.3(page8).

Cuttheorthosiswithanoscillatingsaw,followingtheoutline.

Removetheshellgentlytoavoiddamagingtheproximalpartoftheplastermodel,asitwillbeusedtomouldthesecondshell.

Removethestockingfrominsidetheorthosis.

Grindthetrimlineandsmoothit.

IfanEVAhasbeenmoulded,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

Before moulding the second shell, keep an angle of 90° at the corner of the anterior/proximal trim line because a rounded shape would create a notch in the polypropylene of the posterior shell which might prevent proper functioning of the hinged joint.

Keepthevacuumonuntilthepolypropylenecoolsdown.

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2.6 anterior shell

Repairtheproximalpartoftheplastermodelifnecessary.

2.6.1 Moulding eVa

Toimprovecomfort,6mmEVAcanbemouldedpriortodrapingofthepolypropylene,whetherornotthesamehasbeendonefortheothershell.

Followtheproceduredescribedbelow,orgoontothenextsectionifEVAisnotrequired.

4CutapieceofEVA6mmthickandlargeenoughtocovertheproximalhalfoftheplastermodel.

HeattheEVAat120°for3to5minutes,dependingontheefficiencyoftheoven.

PuttheEVAovertheplastermodelandholdittightlyinplacewithanelasticbandageforoneminute.

4RemovetheEVAandcutit,followingthetrimline.

Takethepolypropyleneshell(withitsEVA)andfixthenewlymouldedEVAwithtwostaplesclosetotheproximal/medialtrimline.

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2.6.2 Vacuum moulding of polypropylene on the anterior shell

4GlueastripofEVA6mmthickand3cmwidearoundthemiddleoftheplastermodel.The polypropylene draping will stop at this level, where the rope tightened around the EVA will ensure a sufficient vacuum.

GlueanotherstripofEVA6mmthickand3cmwideonthemiddleofthefirstpolypropyleneshellatrightanglestothefirststrip.This will allow the polypropylene to be cut after draping without damaging the shell beneath.

Coverwithastockingtheareareceivingthepolypropylene.Do not cover the strip of EVA where the rope will be tightened because the vacuum may leak through the stocking mesh.

Placetheplastermodelwiththeforefootpointingupwards.

Dustthestockingwithtalcumpowder.

Cutapieceofpolypropylene:• width,kneecircumference+5cm;• length,halftheleglength+10cm;• thickness,4mmor5mm,dependingonthepatient’sweight.

Heatthepolypropyleneat180°for15to20minutes,dependingonthethicknessofthepolypropyleneandtheefficiencyoftheoven.

4DrapethepolypropyleneovertheplastermodelandstickittogetheralongthelongitudinalstripofEVA.

Tightenthepolypropylenearoundthesuctioncone.

Openthevacuumvalve.

Cutofftheexcesswithapairofscissorswhilethepolypropyleneisstillhot.

Keepthevacuumonuntilthepolypropylenecoolsdown.

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2.6.3 Preparation of the anterior shell

Drawthetrimlineonthepolypropyleneasexplainedinsection2.3(page8).

CutcarefullyalongtheEVAstripinthemiddleoftheposteriorshellwithanoscillatingsaw.

Removetheposteriorshellfromtheplastermodel.

Removethestockingfrominsidetheorthosisandcutofftheexcesswithajigsaw.

Grindthetrimlineandsmoothit.

IfanEVAsheethasbeenmoulded,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

2.7 Preparation for initial fitting

2.7.1 Preparation of the hinged joint

4SecurethetwoshellsontheplastermouldwithScotchtape.

Markthepositionofthehingedjointonthelateralandmedialsides:• 4.5cmabovethepatellartendon

groove;• inthemiddleoftheantero-

posteriordiameter.

Makesurethatthehingedjointsonbothsidesareatthesamelevel.

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4Drillahole3mmindiameterthroughbothshells.

4Assembletheanteriorandposteriorshellswith2slottedscrewsandnuts3mmindiameter(headinside).

Cutandgrindtheboltprotrudingfromthenut.

2.7.2 Proximal strap

Useaready-madeVelcrostrap25mmwide,ormakeastrapwithnylonwebbingorsomeotherstrongmaterial.

4Withatubularrivet,fixthebeltholdingthelooponthemedialsideoftheposteriorshell,atthedistallimitoftheanteriorshell.

Theloopshouldbelocated5mmfromtheanteriorshell.

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4Insertthebeltthroughthelooptomeasurethelength.

Fixthestrapwithatubularrivetonthelateralside.

Makesurethestrapisperfectlyhorizontalbeforefixingit.

2.7.3 distal strap

Thisstrapisnotalwaysneeded.Thedecisiontoinstallitorotherwisewilldependonthecapacityofthepatient’sshoetoholdthefootinsidetheorthosis.

Usea25mmVelcrostrap.

4Withalargetubularrivet,fixthebeltholdingthelooponthemedialside,4cmabovethemalleoli.

Theloopshouldbeplacedonthepolypropyleneandnotbeincontactwiththepatient’sleg.

4Fixthestrapwithalargetubularrivetonthelateralside.Makesurethestrapisperfectlyhorizontalbeforefixingit.

Coverthesurfaceofthestrapincontactwiththepatient’slegwith3mmEVA.

2.7.4 Preparation of the eVa

IfEVAisused,glueittemporarilyinsidetheorthosis.

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2.8 Initial fitting and finishing

4Thepatientputsontheorthosisbyopeningtheanteriorshellandslidinghis/herfootthroughtheproximalend.

TheinitialfittingisperformedinaccordancewithP&Ostandards,takingthefollowingpointsintoaccount.

• Shouldthepatient’slegslipthroughthebrim,theproximalpartcanbepaddedwithEVAtodecreaseitswidth.

• Whilethepatientisstanding,checkthedegreeofweightrelief.• Aheelliftonthecontrolateralsidemightbeneededtoaccommodatetheincreaseinlengthofthe

legwiththeorthosis.

2.8.1 Finishing of the polypropylene

4Roundoffthecornersofbothanteriorandposteriorshells.

Carryoutanymodificationsrequiredonthepolypropyleneandsmooththetrimline.

GluetheEVAcompletelyinsidethepolypropylene,cutofftheexcessandsmooththetrimline.

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2.8.2 Finishing of the hinged joint

Usetwocopperrivets3mmindiameterwithtwobrassorstainlesssteelwashers.

Removethe3mmboltononesideofeachrivet.

Heatthecopperrivetwithaweldinggunand“stamp”itsheadintothepolypropyleneoftheanteriorshellinordertocreatedepressionstocountersinktherivethead.

4Placetherivetheadonananvilandhammergentlyonthepartoftherivetprotrudingfromthewasherinordertocreateasmooth,roundedshapeasshownonthepicture.Usearivetsettorounditoff.

Inserttherivet,headinside,andinstallthewasheroutside.

Cuttherivetwithdouble-actioncuttingpliersorside-cuttingplierssothatonly2mmprotrudesfromthewasher.

Dothesamefortheotherside.

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PTBO WITh POsTeRIOR-ClOsIng shell3

3.1 eVa preparation for increased weight relief

The EVA is placed only under the posterior part of the foot, in order to avoid an increase in volume at the mid-foot which may prevent the patient from wearing normal shoes.

Followtheproceduredescribedbelow,orgoontothenextsectionifthepatientdoesnotrequireadditionalweightrelief.

4PlacethemetatarsalheadoftheplastermodelattheedgeoftheEVAsheetanddrawalinearoundit1cmwiderthanthefoot.

4Holdtheplastermodelinavice.

HeattheEVAat120°for3to5minutes,dependingonthethicknessoftheEVAandtheefficiencyoftheoven.

PuttheEVAundertheposteriorpartofthefootandholditfirmlyinplaceforoneminutewithanelasticbandage.

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GrindtheedgeoftheEVAuntilitisperfectlyaligned,aroundandbelow,withtheshapeoftheplastermodel.

6GluetheEVAundertheplastermodel.

3.2 Moulding of eVa

EVA(6mm)canbemouldedpriortodrapingofthepolypropylenetoimprovecomfort.

Do not cover the foot, as this would create an increase of volume which might prevent the patient from wearing normal shoes.

Followtheproceduredescribedbelow,orgoontothenextsectionifEVAisnotrequired.

Placetheplastermodelwiththeforefootpointingupwards.

4CutapieceofEVA:• width,kneecircumference;• length,leglength;• thickness,6mm.

HeattheEVAat120°for3to5minutes,dependingontheefficiencyoftheoven.

DrapetheEVAovertheplastermodelmanuallyandholditinplaceuntilithascooledcompletely.

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4Cutofftheexcesswithacutterorapairofscissors.

Grindthedistaltrimlinetograduallyreduceitsthickness.

StapletheEVAontothebackoftheplastermodel.

3.3 Orthosis trim line

4Markthetrimlineasfollows:

A Thetopmustbehorizontal,6cmabovethepatellatendongroove.

B Thepatellaandthehamstringtendonsareleftfree.

C Theshelloverlapstheantero-posteriormid-lineby1.5cm.

D Attheankle,thelinemustremainabovethemalleolitofacilitatedonning.

E Theusualdistallimitoftheposteriorshellishorizontal,at1/3ofthelengthoftheleg,butitmaybelongertoprovidegreaterprotection.

F Attheforefoot,clearthesideandthetopofthetoesandtheheadofthemetatarsuscompletely,passingbeneaththem.This will allow the polypropylene to follow the movement of the metatarso-phalangeal joints.

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3.4 Plastic reinforcement

Lateralreinforcements(channels)significantlyimprovethestrengthoftheorthosis.Thereareseveralwaysofmakingthesereinforcements.

4CuttwostripsofEVA:• width10mm;• length20cm;• thickness,6mm.

Grindbothdistalandproximalendstograduallyreducetheirthickness.

Gluethestripsontotheplastermodel,1cmanteriortothelateralandmediallongitudinalaxis.

Reinforcements prolonged along the side of the mid-foot increase the volume of the orthosis so that it may no longer fit into the patient’s shoe.

3. 5 anterior shell

3.5.1 Vacuum moulding of polypropylene

The procedure described below ensures uniform thickness of the polypropylene all over the orthosis. Do not try to make a single seam on the anterior side, because the creases gathering at ankle level will make it necessary to stretch the polypropylene too thinly.

Ifthishasnotyetbeendone,pullastockingovertheplastermodel.For maximum efficiency the EVA used to channel the polypropylene must not be covered with a stocking.

Dustthestockingwithtalcumpowder.

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Measurementofthepolypropylenesheet:

� Kneecircumference+10cm.� Instepcircumference+10cm.� Legandfootlength+10cm.

Thickness,4mmor5mm,dependingonthepatient’sweight.

Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheefficiencyoftheoven.

Drapethepolypropyleneovertheplastermodelandstickittogetheralongtheposteriorsideandunderthefoot.

Tightenthepolypropylenearoundthesuctioncone.

Openthevacuumvalve.

4Cutofftheexcesswithapairofscissorswhilethepolypropyleneisstillhot.

Keepthevacuumonuntilthepolypropylenecoolsdown.

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3.5.2 Preparation of the anterior shell

Drawthetrimlineonthepolypropyleneasexplainedinsection3.3(page21).

Cuttheorthosiswithanoscillatingsaw,followingtheoutline.Toremovetheshell,itmightbenecessarytobreakthedistalpartoftheplastermodelbelowtheankle.However,caremustbetakennottodamagetheproximalpart,whichisneededtomouldthesecondshell.

Removethestockingfrominsidetheorthosis.

Grindtheorthosistrimlineandsmoothit.

IfanEVAhasbeenmoulded,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

Before moulding the second shell, keep an angle of 90° at the corner of the posterior/proximal trim line because a rounded shape would create a notch in the polypropylene of the posterior shell which might prevent proper functioning of the hinged joint.

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3.6 Posterior shell

Repairtheupperhalfoftheplastermodelifnecessary.

3.6.1 Moulding eVa

Followtheproceduredescribedinsection2.6.1(page12).

3.6.2 Vacuum moulding of polypropylene on the posterior shell

Followtheproceduredescribedinsection2.6.2(page13).

3.6.3 Preparation of the posterior shell

Drawthetrimlineonthepolypropyleneasexplainedinsection3.3(page21).

CutcarefullyalongtheEVAstripinthemiddleoftheanteriorshellwithanoscillatingsaw.

Removetheposteriorshellfromtheplastermodel.

Removethestockingfrominsidetheorthosisandcutofftheexcesswithajigsaw.

Grindthetrimlineandsmoothit.

IfEVAhasbeenmoulded,transferthetrimlinetotheEVAandcutofftheexcesswithapairofscissors.

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3.7 Preparation for initial fitting

3.7.1 Preparation of the hinged joint

Followtheproceduredescribedinsection2.7.1(page14).

3.7.2 Preparation of the straps

Followtheproceduredescribedinsection2.7.2(page15)fortheproximalstrap,andsection2.7.3(page16)forthedistalstrap.

3.7.3 Preparation of eVa

IfEVAisused,glueittemporarilyinsidetheorthosis.

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3.8 Initial fitting and finishing

Seesection2.8(page17).

4Itisoftennecessarytoflarethepolypropyleneattheposteriorpartoftheheelinordertofacilitatedonningandtoavoidpainfulcontactwiththeedgeoftheplastic.

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ICRC Code Description Unit of measure Quantity

For negative and positive cast :ODROSTOCOT60 Tubular stockinet, 60 cm Cm 70According to size:• MDREBANDP10• MDREBANDP12• MDREBANDP15

Plaster of Paris bandages10, 12 or 15 cm x 3 m

Piece 3

OTOOPLASPW40 Plaster of Paris powder Each As requiredFor EVA and plastic moulding :If required, according to colour:• OPLAEVAFERA06• OPLAEVAFLIV06• OPLAEVAFKIN06

EVA 6 mmTerra, olive or beige colour

Each As required

None Nylon stockinet Piece 1According to colour and thickness:• OPLAPOLYCHOC04• OPLAPOLYCHOC05• OPLAPOLYLIV04• OPLAPOLYLIV05• OPLAPOLYSKIN04• OPLAPOLYSKIN05

HomopolymerTerra, olive or beige colour,4 or 5 mm thick

Each As required

For the strap:OSBOSTRVP325 Strap, Velcro, PVC, with loop, brown, 300 mm x 25 mm Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2

orOSBOVSBO24 Strap, Perlon webbing, 25 mm Cm 25None Strap, Velcro, 25 mm Cm 20OSBOVSBO35 Loop, 25 mm x 100 pieces Piece 1OHDWRIVET131 Rivet, tubular, 13 mm x 12 mm Piece 2For the hinged joint:OHDWRIVEC032 Rivet, copper, 3 mm x 20 mm Piece 2OHDWWASHB133 Washer, brass, 13 mm dia. x 3.1 mm thick Piece 2

list of manufacturing materials

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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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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

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.

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Table of contents

Foreword 2Introduction 41.Casting,measurementandrectification 42.Preparationofreinforcements 63.Polypropylenedrapingandvacuummoulding 74.Positionofthesidebars 95.Trimlines 116.Assemblyandparallelism 127.Initialfittings 138.Finishing 149.KAFOoptions 15Listofcomponentsandmaterials 16

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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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Objective of the manuals

TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.

Themainaimsoftheseinformativemanualsareasfollows:

• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.

Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.

ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme

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Introduction

Theaimofthisdocumentistodescribeamethodforproducingknee-ankle-foot orthoses (KAFO),workingwithpolypropylenetechnologyandcommercialuprightsidebarswithdroplocksasusedattheICRC’sphysicalrehabilitationcentres.

Thecastingandrectificationmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.

Someimportantpointsshouldneverthelessbetakenintoaccount:

1.1 Anatomy and landmarks

4Malleoli

4The1stand5thmetatarsalheads

4Navicularbone

4Baseof5thmetatarsal,ifprominent

4Greattrochanter

4Medialtibialplateau

4Headoffibula

CAsTIng, meAsuRemenT And ReCTIFICATIOn1

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1.2 Cast rectification method

Oncerectificationiscompleted,checkthefollowing:

4Theposteriorlinepassesthrough

1.themiddleofthethigh2.themiddleoftheknee3.themiddleoftheankle

4Heelandforefootareflatontheground

4Thelaterallinepassesfromthegreattrochantertothemiddleofthelateralmalleolus

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1.3 mechanical knee joint location

4MechanicalaxesaredefinedinaccordancewithP&Opractice,asshownhere.

Thepositiveplasterremainsinaverticalposition:

4Drivetwonailsintothemouldatthemechanicalkneeaxis(theyshouldprotrudeabout5mm)

4Pullanylonorcottonstockingoverthemould

4FixtheEVAreinforcementaccordingtothemeasurementcardandrequirements

4Dustthestockingwithtalcumpowder

PRePARATIOn OF ReInFORCemenTs2

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POlyPROPylene dRAPIng And vACuum mOuldIng3

Cuta5mmsheetofpolypropylene(PP)asfollows:

4Heatthepolypropyleneat180°for20to25minutes,dependingonthethicknessofthepolypropyleneandtheperformanceoftheoven.

Drapethepolypropyleneovertheplastermodel.Laythepolypropyleneoverthemouldwithoutstretchingit.

CleanthePPsheet.

4Uppercircumference+10cm

4Totallength+20cm

4Lowercircumference+15cm

3

1

2

3

2

1

Drapeitfirstovertheankletowardsthemiddleanteriorpartoftheorthosismould.Thenpullitaroundtheforefoot.

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4Stickittogetheralongtheanteriorside.

4Tightenthepolypropylenearoundthesuctionconewitharopeorsomethingsimilar.

Openthevacuumvalve.

4Withscissorsoraknife,cutofftheexcesspolypropylenealongtheweldingseamwhileitisstillhot.

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Remarks

Ifthepolypropylenesheetcutaccordingtothemeasurementsoftheplasteristoobigtofitintotheoven,preparetwoPPsheetsinsteadofone.

DrapethePParoundtheplastermould.

Payattentiontotheoverlaparea,pullingthePPgraduallyandcarefully;otherwiseitwillbestretchedtoothinlyandbetooweak.

OpenthevacuumvalveandremovetheexcessPPalongtheseam.

POsITIOn OF The sIde bARs4

4Onthebench,thepositivemouldisinstalledasfollows:

4Thepositionofthekneeaxisshouldbemarkedinrelationtotheverticallineindicatingthelocationofthemechanicalkneejoint.

kneeaxis

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4Theuprightsarecuttotherequiredlength,bentandadjustedfollowingthecurvesofthePPshells.

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4Duringadjustmentofthesidebars,thepositionandparallelismofthekneeaxismustberespected.

Axislocationandtrimlines

4TrimlinesdependonthetypeofcorrectionrequiredandthefunctionoftheKAFO.

Inmostcases,trimlinesshouldbedrawnaccordingtointernationalP&Ostandards,asshownhere:

TRIm lInes5

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4ThepolypropyleneiscutoffandthetrimlinecontoursaregroundandpolishedbeforetemporaryassemblyoftheKAFOfortrial.

Assembly And PARAllelIsm6

4ThesidebarsaretemporarilyfixedonthepolypropyleneshellswithM3screwsandnuts.

Preciseparallelismofthekneejointisoftheutmostimportanceandmustbeensuredbeforethefirstfittingasfollows:

4method 1:UsingaVerniercalliper

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InITIAl FITTIngs7

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4method 2:Usingthecentringpin

4StraptheKAFOonthepatient’slowerlimb.

4Checkthetrimlinesbeforethepatientstandsup.

Oncetheshoesareon,thepatientstandsupandgaittrainingcanbegin.

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FInIshIng8

4Thestrapsarefixedwithtubularrivets

4Thetrimlinesarecarefullypolished

4Theuprightscanbecoveredwithfineleather

4Theparallelismofthekneejointischeckedagain

4Theuprightsarefixedwithcopperrivets

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KAFO OPTIOns9

Manufac tur ing Guidel ines Knee -Ankle -Foot O r thosis

4TheKAFOisreadyfordelivery

4Somepatientsneedanischialseatsupport.Inthiscasethebrimhasananterioropening.Theshapeissimilartothatofquadrilateralsocketprosthesis.

4TheKAFOcanbefittedwithdifferentorthoticjoints(Swisslock,droplock,freeoffset,etc.).

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ICRC Code Description Unit of measure Quantity

For negative and positive cast :ODROSTOCOT60 Tubular stockinet, 60 cm Cm 135MDREBANDP10-12-15 Plaster of Paris bandages10, 12 or 15 cm x 3 m Piece 6 to 7OTOOPLASPW40 Plaster of Paris powder Each As requiredFor EVA and plastic moulding :OPLAEVAFKIN06 EVA FOAM 6 mm x 0.95 m x 0.95 m, 0.90 m2, skin colour Sheet 0OPLAPOLYSKIN 04 HOMOPOLYMER 4 mm or 5 mm x 1 m x 2 m 7.5 kg, beige colour Sheet 0.5For components/ sidebars:OCPOKNEEB20DL/16DL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint w.drop lock (pairs) Pair 1OCPOKNEEBO20SL/16SL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint, Swiss lock (pairs) Pair 1OCPOKNEEBO20DL/16DL ORTHOSIS, ADULT, 20 mm or 16 mm side bar knee joint w.drop lock (pairs) Pair 1For straps and rivets:OSBOVSBO26 ELASTIC STRAP 25 mm x 25 m Roll 0.02EHDWZBAKGLUE01 GLUE, SYNTHETIC Litre 0.2OSBOVSBO36 LOOP 35 mm x 100 pcs Box 0.04EBUIZBAKPOPPOWD PLASTER POWDER Kg 12EHDWOHPW45 RIVET (COPPER) 4 mm x 20 mm x 1,000 pcs Box 0.012EHDWOHDW40 RIVET (TUBULAR) 13 mm x 12 mm x 1,000 pcs Box 0.012ORTOZBAKSPAR SANDPAPER 15 x 15 Piece 1OSBOVSBO29 STRAP (PROSTHESIS) 35 mm x 50 m Roll 0.02OSBOVSBO25 STRAP (VELCRO) 30 mm M 1OOMAALIGORTH CENTRING PIN FOR ORTHOSIS 1 30ETOOMEASC15 VERNIER CALLIPER 1 35Special hand tools:OTOOMEASCIR4 _ 7 COUNTOURING INSTRUMENT, ROUND BEAK Each 2OTOOMEASCFL COUNTOURING INSTRUMENT, FLAT Each 2OOMAALIGORTHX CENTRING PIN FOR ORTHOSIS Each 1ETOOMEASC15 VERNIER CALLIPER Each 1

list of components and materials

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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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