Prosthetics and Orthotics Manufacturing Guidelines - 2 ... · trans-humeral Prosthesis 0868/002...
Transcript of Prosthetics and Orthotics Manufacturing Guidelines - 2 ... · trans-humeral Prosthesis 0868/002...
Physical Rehabilitation Programmetrans-humeral Prosthesis
0868
/002
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9/20
06
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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
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Table of contents
Foreword 2Introduction 41.Castingandrectification 52.Positioningofthesocketcupfortheelbowunit 63.Polypropylenedraping 74.Assembly 85.Makingthehookcableattachments 96.Polypropylenedrapingforcableattachment 117.Shapingthecableattachment 128.Fixationofthehookcableattachments 139.Shoulderharness 1410.Finishedtrans-humeralprosthesis 18Listofcomponents,CREquipmentsSA(CRE) 19Listofothermanufacturingmaterials 20
Manufac tur ing Guidel ines Trans-Humeral Prosthesis
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
Foreword
The ICRC polypropylene technology
Sinceitsinceptionin1979,theICRC’sPhysicalRehabilitationProgrammehaspromotedtheuseoftechnologythatisappropriatetothespecificcontextsinwhichtheorganizationoperates,i.e.,countriesaffectedbywarandlow-incomeordevelopingcountries.
Thetechnologymustalsobetailoredtomeettheneedsofthephysicallydisabledinthecountriesconcerned.
Thetechnologyadoptedmustthereforebe:
• durable,comfortable,easyforpatientstouseandmaintain;• easyfortechnicianstolearn,useandrepair;• standardizedbutcompatiblewiththeclimateindifferentregionsoftheworld;• low-costbutmodernandconsistentwithinternationallyacceptedstandards;• easilyavailable.
Thechoiceoftechnologyisofgreatimportanceforpromotingsustainablephysicalrehabilitationservices.
Forallthesereasons,theICRCpreferredtodevelopitsowntechniqueinsteadofbuyingready-madeorthopaediccomponents,whicharegenerallytooexpensiveandunsuitedtothecontextsinwhichtheorganizationworks.ThecostofthematerialsusedinICRCprostheticandorthoticdevicesislowerthanthatofthematerialsusedinappliancesassembledfromcommercialready-madecomponents.
WhentheICRClauncheditsphysicalrehabilitationprogrammesbackin1979,locallyavailablematerialssuchaswood,leatherandmetalwereused,andorthopaediccomponentsweremanufacturedlocally.Intheearly1990stheICRCstartedtheprocessofstandardizingthetechniquesusedinitsvariousprojectsaroundtheworld,forthesakeofharmonizationbetweentheprojects,butmoreimportantlytoimprovethequalityofservicestopatients.
Polypropylene(PP)wasintroducedintoICRCprojectsin1988forthemanufactureofprostheticsockets.Thefirstpolypropyleneknee-jointwasproducedinCambodiain1991;othercomponentssuchasvariousalignmentsystemswerefirstdevelopedinColombiaandgraduallyimproved.Inparallel,adurablefoot,madeinitiallyofpolypropyleneandEthylVinylAcetate(EVA),andnowofpolypropyleneandpolyurethane,replacedthetraditionalwooden/rubberfoot.
In1998,aftercarefulconsideration,itwasdecidedtoscaledownlocalcomponentproductioninordertofocusonpatientcareandtrainingofpersonnelatcountrylevel.
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
Objective of the manuals
TheICRC’s“ManufacturingGuidelines”aredesignedtoprovidetheinformationnecessaryforproductionofhigh-qualityassistivedevices.
Themainaimsoftheseinformativemanualsareasfollows:
• TopromoteandenhancestandardizationofICRCpolypropylenetechnology;• Toprovidesupportfortrainingintheuseofthistechnology;• Topromotegoodpractice.
Thisisanotherstepforwardintheefforttoensurethatpatientshaveaccesstohigh-qualityservices.
ICRCAssistanceDivision/HealthUnitPhysicalRehabilitationProgramme
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Introduction
Thisdocumentdescribesamethodforproductionoftrans-humeral prostheses,workingwiththeICRCpolypropylenetechnologyandorthopaediccomponentsusedattheRegionalPhysicalRehabilitationCentreinBattambang,Cambodia.
Thecasting,rectificationandalignmentmethodsusedcorrespondtointernationalprostheticandorthotic(P&O)standardsofpracticeandarethereforenotdescribedintheseICRCmanufacturingguidelines.
ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
CasTIng and ReCTIFICaTIOn1
4Patientassessment,castingandrectificationofpositivecastimpressionsareperformedinaccordancewithP&Ostandards.
4Alignmentlinesantero-posteriorandmedio-lateral(A-P,M-L)aredrawnonthepositivemouldforproperpositioningoftheelbowcup.Inmostcases,thiswillbealongthecentralaxisofthetrans-humeralstump.
Drivenailsintothedistalendofthecasttoensuregoodadherenceforthebuild-upoftheplasterextension.
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
POsITIOnIng OF The sOCkeT CuP FOR The elbOw unIT2
4MakeaconicalextensiontubeusingEVA,plasticsheetingorsomeothersuitablematerialandpositionitaccordingtothealignmentlinesfortheelbowcup.Tapetheconeinplaceandfillitwithplasteruptotheleveloftheproximalendoftheelbowcup.
Formeasurementsseefollowingparagraph.
4Prolongtheproximalalignmentlinesalongtheplasterextensioninordertofacilitatepositioningoftheelbowcup.
Themeasurementfromtheacromiontothelateralepicondyleofthesoundside,minusthedistancefromtheelbowaxistothedistalendoftheelbowcup,willdeterminethelengthofthetrans-humeralsocket.
Driveanailintothedistalpartofthebuild-uptoensuregoodadherenceofthecup,andfixthecupinproperalignmentwithwetplasterinaccordancewithP&Ostandards(useanalignmenttableifavailable).
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
POlyPROPylene dRaPIng3
4Measurementsforpolypropylenesheet:
Cupcircumference+2cm Acromioncircumference+5cm Lengthofplastercast+15cm
Thicknessofsheet:4mm
Heatthepolypropyleneinanovenforabout20minutesat180°C.
4Beforedrapingthepolypropylenesheet,pullastockingovertheplastermould.Cutitattheproximalpartoftheelbowcupandfixitwithcontactglue.Dustthestockingwithtalcumpowder.
4Drapethepolypropyleneovertheplastermodelandstickthesidestogetheralongthemedialsideofthesocket.Tightenthepolypropylenearoundthesuctionconeortubeusingabicycleinnertube,ropeorstocking,thenopenthevacuumvalve.
� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
assembly4
6Removetheplaster,shapethesockettrimlinesandgrindthemedialweldingseam.
Flattenthepolypropyleneonthedistalendoftheelbowcup.
Assembletheelbowunitandcuttheforearmaccordingtothemeasurement.Thelengthoftheforearm,includingthehook,shouldbe1to2cmshorterthanthesoundside.Fixthewristunitwith4panheadPhillipsframingscrews(8x3mm).
�ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
4Forthehookcableattachments,duplicatetheoutsidedistalpartofthetrans-humeralsocketandtheforearmwithplasterbandages.Fillthetwonegativeswithplasterandsmooththem.
4Pullstockinetovertheplastermodels.
makIng The hOOk Cable aTTaChmenTs5
�0 ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
4Onthearmmould,placeabicyclebrakecablehousing7cmabovethedistalendoftheelbowcupandcurvetheupperpartaccordingtothepositionoftheharness.
Ontheforearm,placetheproximalcablehousingdummylaterally,3cmfromtheelbowaxis,toallowfullflexionoftheforearm.Thedistalcablehousingisplacedontheanteriorpartoftheforearm,atleast5cmfromthewrist,toallowrotationofthehook.
4Fixthecablehousingdummiestothestockinetwithcontactglue.
Topreventthecablehousingsfrombeingflattenedwhendrapingthepolypropylene,insertanelectricwireinthem.
Itispossibletomakeseveralhookcableattachments(e.g.leftandright)onthesamemould.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
POlyPROPylene dRaPIng FOR Cable aTTaChmenT6
4Drapea3mmpolypropylenesheetoverthearmusingthesamemeasurementsanddrapingtechniquesasforthetrans-femoralsocket.
4Whenthepolypropylenehascooled,markthetrimlinesofthehookcableattachmentsandcutwithanoscillatingsaw.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
shaPIng The Cable aTTaChmenT7
6Cutandshapethepolypropylenecablefixationsandinsertthecablehousingintothechannels.
Drillholescorrespondingtothediameterofthetubularrivetsorscrews(seenextparagraph).
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
FIxaTIOn OF The hOOk Cable aTTaChmenTs8
4Thefinishedhookcableattachmentsareplacedinthesamepositionasontheplastermould.
Ontheforearmtheyarefixedwith
countersunkheadself-tappingscrews(d1=3mm,L=10mm).
4Onthetrans-humeralsocket,thehookcableattachmentisalsoplacedinthesamepositionasontheplastermould.
Fixtheattachmentwithtubularrivets(8x9mm).
Shouldthepositionoftheattachmentshavetobechanged,warmthemwithaheatgunandmouldthemagainagainstthearmsocketorforearm.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
shOuldeR haRness9
6Insertthebicyclebrakecableintothehousing.Ontheproximalpart,fixawebbinghangerwithascrewclamp.Onthedistalpart,makealoopwiththecableandsecureitwithasmallmetaltube(clampsleeve),whichisflattened(pressed)aroundthecable.
6Thesimplesttypeofharnessforoperatingthehookisthe“figureofeight”suspension.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
4Foldthenylonbeltaroundtheoppositeshoulder.Theconnectionshouldbeadjustedinthemiddleoftheback(spine).
4Stapleorclamptheharnesstogether.Whencuttingthebelt,leaveitalittlelongersothatitcanbereadjusted.
Checkwiththeamputeethatthecablecontrolsystemfunctionsproperlyindifferentarmpositions.
Toopenthehook,thepatientmoveshisshoulderonthesoundside(oppositesidefordoubleamputees)ortheprosthesisforward.
4Oncetheharnesshasbeenadjustedsothattheamputeefeelscomfortablewithit,sewthebeltconnectionandthefixationontothewebbinghanger.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
4Topreventfraying,meltthefibresattheendofthebeltwithaweldingiron.
4Theharnessisconnectedtothewebbinghangerontheposteriorside,whiletheotherendisfixedtotheanteriorwallwithatubularrivet.
Theelasticstrapenablestheamputeetoopenandclosetheworkinghook.
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
6Otherharnessingsystems,suchasthoseproducedbytheOttoBockCompany,maybeused.
�� ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
FInIshed TRans-humeRal PROsThesIs10
4Nexttothehookorworkingring,acosmetichandorothertoolrequiredbythepatientmaybeattached(screwedon).
��ICRC Physical Rehabi l i tat ion Programme Manufac tur ing Guidel ines Trans-Humeral Prosthesis
ICRC Code Description Unit of measure Quantity
OCPOELBOKIAOCPOELBOLIAOCPOELBOERA
*Elbow, adult *Elbow kits are available in three different colours. Choose ICRC code according to colour.**** Skin colour** Olive colour** Terra colour
One elbow kit comprises:• Elbow unit• Elbow cup with M6 T-nut• Rubber joint, D70 x d6 x H3 mm• PP wrist unit with M10 T-nut, dia. 45 mm• Pan head Phillips framing screws 8 x 3 mm for wrist unit
Kit
EachEachEachEachEach
1
11114
OCPOHOOKAL
OCPOHOOKAR
KORTHOOKSP
*Hook, adult, left, stainless steel, M10 threadAccording to side of amputation
*Hook, adult, right, stainless steel, M10 thread*According to side of amputation
Spare parts for hook:Rubber washer, D30x d10x H6 mmStainless steel spring
Each
Each
EachEach
1
1
1010
OCPOHOOKKRT *Working round ring tool, stainless steel with rubber washer*On request by amputee
Each 1
OCPOHANDERMLOCPOHANDERMROCPOHANDERWLOCPOHANDERWR
Terra colour:Hand, man, left, terra colourHand, man, right, terra colourHand, woman/child, left, terra colourHand woman/child, right, terra colour
EachEachEachEach
1111
OCPOHANDKIMLOCPOHANDKIMROCPOHANDKIWLOCPOHANDKIWR
Beige colour:Hand, man, left, beige colourHand, man, right, beige colourHand, woman/child, left, beige colourHand, woman/child, right, beige colour
EachEachEachEach
1111
OCPOHANDLIMLOCPOHANDLIMROCPOHANDLIWLOCPOHANDLIWR
Olive colour:Hand, man, left, olive colourHand, man, right, olive colourHand, woman/child, left, olive colourHand, woman/child, right, olive colour
EachEachEachEach
1111
list of components, CR equipments sa (CRe)
�0 ICRC Physical Rehabi l i tat ion Programme
ICRC Code Description Unit of measure Quantity
MDREBANDP10
MDREBANDP12
Plaster bandages 10 cmorPlaster bandages 12 cm
According to stump dimension
OMIS Plaster of Paris According to cast dimensionOMIS Nails Each 4OPLAEVAFERA03OPLAEVAFKIN03OPLAEVAFLIV03
EVA 3 mm, plastic sheet or other for extension tube Each 1, dimension according to TH socket extension length
OMIS Tubular nylon stocking, 60 or 80 mm for PP draping Each 1, length according to TH socketOMIS Bicycle brake housing dummies with electric cable Each Length described in book cable
attachments
OPLAPOLYCHOC04OPLAPOLYCHOC05
OPLAPOLYSKIN04OPLAPOLYSKIN05
OPLAPOLYLIV04OPLAPOLYLIV05
Polypropylene 4 or 5 mm according to patient size:Polypropylene 4 mm, terra brownPolypropylene 5 mm, terra brown
Polypropylene 4 mm, beigePolypropylene 5 mm, beige
Polypropylene 4 mm, olivePolypropylene 5 mm, olive
Each Dimension explained in PP draping technique
OPLAPOLYCHOC03OPLAPOLYSKIN03OPLAPOLYLIV03
Polypropylene 3 mm for cable attachment dummies:Polypropylene 3 mm, terra brownPolypropylene 3 mm, beigePolypropylene 3 mm, olive
Each
OMIS Definitive bicycle brake cable with housing Each 1, cut according to patient sizeOMIS Fixation for cable attachment on forearm:
Countersunk head self-tapping screws d1 = 3 mm, L = 10 mm
Each 4
OHDWRIVET081
Fixation for PP cable attachment on trans-femoral socket and harness: Tubular rivets 8 x 9 mm
Each 5
OMIS PP webbing hanger or other fixation method Each 1OMIS
OCPOELBOHAR
Harness nylon (or other) belt (width 25 mm) with elastic strap (width 25 mm)orHarness for upper limb prostheses
Each 1, length according to patient size
list of other manufacturing materials
MISSION
The International Committee of the Red Cross (ICRC) is an impartial, neutral and independent organization whose exclusively humanitarian mission is to protect the lives and dignity of victims of war and internal violence and to provide them with assistance. It directs and coordinates the international relief activities conducted by the Movement in situations of conflict. It also endeavours to prevent suffering by promoting and strengthening humanitarian law and universal humanitarian principles. Established in 1863, the ICRC is at the origin of the International Red Cross and Red Crescent Movement.
Acknowledgements:
Jean François GallayLeo GasserPierre GauthierFrank JoumierJacques LepetitBernard MatagneJoel NiningerGuy NuryPeter PoetsmaHmayak Tarakhchyan
and all prosthetists-orthotists who have worked in ICRC-assisted physical rehabilitation centres.
International Committee of the Red Cross19 Avenue de la Paix1202 Geneva, SwitzerlandT + 41 22 734 60 01 F + 41 22 733 20 57E-mail: [email protected]© ICRC, September 2006All photographs: ICRC/PRP
Physical Rehabilitation Programmeankle-Foot orthosis
Manufacturing guidelines
0868
/002
0
9/20
06
200