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Manufacturing guidelines

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

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.

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

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

� 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 Knee -Ankle -Foot O r thosis

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

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

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

1.2 Cast rectification method

Oncerectificationiscompleted,checkthefollowing:

4Theposteriorlinepassesthrough

1.themiddleofthethigh2.themiddleoftheknee3.themiddleoftheankle

4Heelandforefootareflatontheground

4Thelaterallinepassesfromthegreattrochantertothemiddleofthelateralmalleolus

� ICRC Physical Rehabi l i tat ion Programme

1.3 mechanical knee joint location

4MechanicalaxesaredefinedinaccordancewithP&Opractice,asshownhere.

Thepositiveplasterremainsinaverticalposition:

4Drivetwonailsintothemouldatthemechanicalkneeaxis(theyshouldprotrudeabout5mm)

4Pullanylonorcottonstockingoverthemould

4FixtheEVAreinforcementaccordingtothemeasurementcardandrequirements

4Dustthestockingwithtalcumpowder

PRePARATIOn OF ReInFORCemenTs2

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

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.

� ICRC Physical Rehabi l i tat ion Programme

4Stickittogetheralongtheanteriorside.

4Tightenthepolypropylenearoundthesuctionconewitharopeorsomethingsimilar.

Openthevacuumvalve.

4Withscissorsoraknife,cutofftheexcesspolypropylenealongtheweldingseamwhileitisstillhot.

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

Remarks

Ifthepolypropylenesheetcutaccordingtothemeasurementsoftheplasteristoobigtofitintotheoven,preparetwoPPsheetsinsteadofone.

DrapethePParoundtheplastermould.

Payattentiontotheoverlaparea,pullingthePPgraduallyandcarefully;otherwiseitwillbestretchedtoothinlyandbetooweak.

OpenthevacuumvalveandremovetheexcessPPalongtheseam.

POsITIOn OF The sIde bARs4

4Onthebench,thepositivemouldisinstalledasfollows:

4Thepositionofthekneeaxisshouldbemarkedinrelationtotheverticallineindicatingthelocationofthemechanicalkneejoint.

kneeaxis

�0 ICRC Physical Rehabi l i tat ion Programme

4Theuprightsarecuttotherequiredlength,bentandadjustedfollowingthecurvesofthePPshells.

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

4Duringadjustmentofthesidebars,thepositionandparallelismofthekneeaxismustberespected.

Axislocationandtrimlines

4TrimlinesdependonthetypeofcorrectionrequiredandthefunctionoftheKAFO.

Inmostcases,trimlinesshouldbedrawnaccordingtointernationalP&Ostandards,asshownhere:

TRIm lInes5

�� ICRC Physical Rehabi l i tat ion Programme

4ThepolypropyleneiscutoffandthetrimlinecontoursaregroundandpolishedbeforetemporaryassemblyoftheKAFOfortrial.

Assembly And PARAllelIsm6

4ThesidebarsaretemporarilyfixedonthepolypropyleneshellswithM3screwsandnuts.

Preciseparallelismofthekneejointisoftheutmostimportanceandmustbeensuredbeforethefirstfittingasfollows:

4method 1:UsingaVerniercalliper

��

InITIAl FITTIngs7

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

4method 2:Usingthecentringpin

4StraptheKAFOonthepatient’slowerlimb.

4Checkthetrimlinesbeforethepatientstandsup.

Oncetheshoesareon,thepatientstandsupandgaittrainingcanbegin.

�� ICRC Physical Rehabi l i tat ion Programme

FInIshIng8

4Thestrapsarefixedwithtubularrivets

4Thetrimlinesarecarefullypolished

4Theuprightscanbecoveredwithfineleather

4Theparallelismofthekneejointischeckedagain

4Theuprightsarefixedwithcopperrivets

��

KAFO OPTIOns9

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

4TheKAFOisreadyfordelivery

4Somepatientsneedanischialseatsupport.Inthiscasethebrimhasananterioropening.Theshapeissimilartothatofquadrilateralsocketprosthesis.

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

�� ICRC Physical Rehabi l i tat ion Programme

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

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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0

9/20

06

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