prosthetics and orthotics manufacturing guidelines - 2. upper limb prosthetics - trans ... · 2016....
TRANSCRIPT
Physical Rehabilitation Programmetrans-radial 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: [email protected]© 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.
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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: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
0868
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