Trulife Child's play knee with manual lock Instruction Manual

SSK610A

Child’sPlayKneewithManualLock

InstructionsandUserGuide

29151‐001REVG

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Trulifewww.trulife.comPage1of3

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INTRODUCTION

TheChild’sPlayKneewithManualLockisafour‐bar,polycentrickneethatutilizesamechanicallockingsystemwithamanually

operatedreleaselever.Itisalightweight,low‐profilekneethatprovidesconstantfrictionandspringextension‐assistforpediatric

amputees.TheChild’sPlayKneewithManualLockisappropriateforpediatricamputeeswithlowtohighactivitylevelsandis

compatiblewith22mmendoskeletalmodularprostheticcomponents.

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ProductCode Description   WeightLimit

SSK610A Child’sPlayKneewithManualLock 55kg/121lb

SSK610A‐DIS LaminationBracketforSSK610A  55kg/121lb

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LIMITATIONS

TheChild’sPlayKneewithManualLock(SSK610A)requiresaclearanceof15mm(.59")fromcenterofkneetothemountingsurface.

Thekneereachesfullflexionat140°.

INSTALLATIONANDUSE

Warning:Recommendedinstallationanduseproceduresmustbefollowedformaximumsafetyandservicelife.Nevermodifythe

Child’sPlayKneewithManualLock.Failuretofollowtheinstallationanduseproceduressetforthfollowingmayleadto

structuralfailureofthecomponentssubjectingtheusertoariskofseriouspersonalinjury.

Warning:Donotexposekneetowater.Ifthekneecomesincontactwithwater,theextensionassistcontrolshouldbethoroughly

evaluatedforfunctionality.

SocketAttachment

SSK610Acomespreassembledwithapyramid(SSK610A‐PYR).Theattachmentscrewshouldbetightenedto66Nm(48.7ft‐lbs)

usingan8mmhexdriver.Uselow‐strengththreadretainingcompoundsuchasLoctite242orsimilar(thisistopreventgallingor

seizingofthethreadswhentheboltistightened).ArotatableKneeDisarticulationMountingBracket,(SSK610A‐DISLaminating

BracketforSSK610A),isalsoavailableandisdesignedtobelaminatedintoplaceasfollows:

1. Roughenthemountingareaofthesocketsurfacewithsandpapertoensureadhesionofthelamination.

2. Markthepositionofthebracketintheappropriatealignmentonthelaminatedsocket.

3. Bendthemetalmountingbrackettocloselymatchthecontourofthesocketinthedesiredpositionwhilemaintainingcorrect

alignment.Removeanybendingironimpressionsfromthesurfaceofthemetalbracket.

4. Removethemountingbracketfromthekneebylooseningtheattachmentscrewlocateddistallyonthebracketwithan8mm

hexkey.Removetheattachmentscrewandsetitasideuntilthekneeistobere‐assembled.

5. Preparethemountingbracketforlamination.Useclaytoprotecttheattachmentsurfaceandscrewholesfromfillingwith

laminate.BondKembloorPeliteovertheattachmentsurfaceandscrewholetofurtherpreventresinintrusion.

6. Temporarilysecurethemountingbracketintoplacewithmethylmethacrylateorepoxy.Ifnecessary,themountingbracketcan

berivetedintoplacethroughthefourmountingholesforadditionalstrength.

Caution:Testwalkingonanunreinforcedmountingbracketaftertemporarilysecuringitinplacemaycausefailure.

7. Securethemountingbrackettothesocketusingseverallayersoffiberglasscastingtapeasatemporaryreinforcement.When

satisfactoryalignmenthasbeenachieved,removethefiberglasscastingtapebeforeapplicationofthedefinitivelamination.

8. Laminatethemountingbrackettothesocketsurfaceusinganappropriatelystronglayupfortheindividualpatient.

9. Trimthehardenedlaminationtoexposethedistalmountingsurfaceforthescrewhole.Donotcutornickthemountingbracket

whentrimmingthelaminateawayfromthedistalsurfaces.

10. Reinstallthekneeunitintothemountingbracketsothatthelabelisanteriorfacing.

11. Usetheattachmentscrew,previouslysetaside,toattachthemountingbrackettothekneeunit.Useatorquewrenchwithan

8mmhexdrivertotightentheattachmentscrewto66Nm(48.7ft‐lbs).Uselow‐strengththreadretainingcompoundsuchas

Loctite242orsimilar.

Note:

•Theapplicationofthethreadretainingcompoundistopreventgallingorseizingofthethreadswhentheboltistightened,

andtoensurepropertorquevalueisachieved.

SSK610A

Child’sPlayKneewithManualLock

InstructionsandUserGuide

29151‐001REVG

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Figure1:Kneealignment

Figure2:Child'sPlayKneewith

ManualLockadjustments

•Whenadjustingalignmentboltsorscrewsthathavebeenpreviouslyassembledwiththreadretainingcompound,the

threadsofthescrewandscrewholeshouldbecleanedfreeofanyresiduewithamildsolventsuchasisopropylalcohol,

thenreapplynewthreadretainingcompound.

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RotationalAdjustmentoftheSSK610ARelativetoSocket.

TherotationalorientationoftheSSK610AKneecanbemanipulatedonlythroughtheuseoftheSSK610A‐DISLaminationBracket.

1. Loosenthebracketattachmentscrewwithan8mmhexkey.

2. Rotatethekneetothedesiredlocation.Ensurethattheinterlockingsplinesofthekneeandthebracketarefullyseated.

3. Re‐tightentheattachmentscrewto66Nm(48.7ft‐lbs)usingan8mmhexkey.

PylonAttachment

1. Cutthe22mmdiameterpylontotheappropriatelength.Thecutmustbelevel.Removeanyburrsorsharpedgesfromtheend

ofthepylon.

2. Insertthepylonintothedistalendoftheprosthetickneeuntilfullyseatedandrotatetothedesired

position.

3. ApplyLoctite242(orsimilar)lowstrengththread‐lockingcompoundtotheclampbolt.

4. Tightentheclampboltto7.3Nm(5.4ft‐lbs,65in‐lbs)witha5mmhexdriverandtorquewrench.

Caution:Neverpermitapatienttowalkonapartiallyinsertedorshimmedpylon.Thiswillvoidthe

warrantyandcouldcontributetocomponentfailure.

KneeAlignment

Usestandardbenchalignmenttechniquestoobtainthebestperformancefromthiskneeunit.Alignment

reference(kneecenter)shouldbetakenfromthedistalanterioraxisoftheknee,asindicatedinFigure1.

KneeAdjustment

ExtensionBiasAdjustment:

1. Removetheattachedpylonfromthedistalclamp.

2. Usea5mmhexkeytoloosenortightentheextensionspringpre‐loadscrewlocated

insidethedistalclampoftheknee.

•Turningthescrewclockwiseincreasesthekneeextensionbias.

•Turningthescrewcounter‐clockwisedecreasesthekneeextensionbias.

FrictionSwingControl

Loosenortightenthescrewonthelower,anteriorsideoftherearlinkageusinga4mmhex

key.

•Turningthescrewcounter‐clockwisedecreasesthekneefriction.

•Turningthescrewclockwiseincreasesthekneefriction.

StabilityAdjustment

1. Loosenthelockingsetscrewontheleftsideoftherearlinkagewitha2mmhexkey.

2. Looseningortighteningthescrewlocatedontheposteriorsideoftherearlinkage

witha4mmhexkey.

•Turningthescrewcounter‐clockwiseincreasesstability.

•Turningthescrewclockwisedecreasesstability.

Note:Themanuallockingmechanismwillnotfunctionifstabilityisdecreasedtoomuch

3. Re‐tightenthelockingsetscrewtopreventmigrationofthestabilityadjustmentscrew.

LockingMechanism

TheSSK610AChild’sPlayKneewithManualLockhasalockthatcanbemanuallyreleasedwhenkneeflexionisdesiredbyusingthe

lockcable.ThislockcanalsobesetopentoallowfreemotionbyliftingthelockleverandtighteningtheAnti‐lockScrewlocatedon

theupper,leftandrightsidesofthekneeusinga2mmhexkey.UseLoctite®242(orsimilar)onthisscrewtokeepitfrombacking

out.

1. Oncethekneeisassembled,locateanappropriatelocationonthesocketforthelockingmechanismhandleandattachingitto

thesocketwiththescrewprovided.

SSK610A

Child’sPlayKneewithManualLock

InstructionsandUserGuide

29151‐001REVG

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2. Adjustthecableatthehandlebylooseningthesetscrewwitha2mmhexkeyandpullingthecabletautleavingminimalslack.

3. Retightenthesetscrewandtrimexcesscable,ifnecessary.

4. Finetunetheadjustmentbylooseningtheattachmentscrewandslidingthehandlealongtheslotasneeded.

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MAINTENANCE

•Servicetheproductatregularintervals.

•Inspectthekneeforexcessivewearorvisualdamageduringnormalconsultations.

•Instructpatienttodiscontinueuseandcontacttheirphysicianorprosthetistiftheprosthesisstartstomakenoiseorifthey

experienceanychangeinfunction.

•Instructthepatienttonotifytheirphysicianorprosthetistiftheygainasignificantamountofweight.

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QUESTIONS

ContactCustomerServiceat;

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Fax:+18002453765

Email:info‐[email protected]



Canada

Tel:+18002672812

Fax:+16133924139

Email:[email protected]

VisitTrulifeonlineatwww.trulife.com.



TrulifehasappointedMedicalDeviceSafetyService(MDSS)ofHannover,GermanytoactasourEUauthorizedrepresentative.Theymaybe

contactedat:

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FAX(+49)‐511‐62628633

LIMITEDWARRANTY

TrulifewarrantsthatthePRODUCTwillbefreefromdefectsinmaterialandworkmanshipfromthedateofinstallationforthewarrantyperiod

statedonthePRODUCTwarrantycard.

ThiswarrantywillnotapplyifthePRODUCThasbeendamagedbymisuse,abuse,neglect,impropercare,failuretofollowinstructions,abnormal

wearandtear,orintheeventthatthePRODUCThasbeenmodified/repairedbypersonsunauthorizedbyTrulife.

Ifadefectinmaterialorworkmanshipisfoundduringthewarrantyperiod,Trulifewill,atTrulife’soption,eitherrepairorreplacetheproduct.Ifit

isnotpossibletorepairorreplacetheproduct,Trulifewillbelimitedtorefundingthepurchaseprice.

Trulifewillnotbeliableunderanylegaltheoryforanydirect,indirect,special,incidentalorconsequentialdamagesarisingfromtheuseofor

inabilitytousethisproduct.

TheapplicationguidelinesforthisTrulifeproductarefortheuseofandbyacertified,qualifiedpractitioneronly.Patientsarenottoattemptto

applyoradjusttheitemunlessexpresslyinstructedtodosobythepractitionerresponsiblefortheprescriptionand/orinitialfittingofthedevice.

Allpatientquestionsshouldbereferredtothepractitionerandnottothemanufacturer.Themanufacturerwarrantsonlythattheenclosed

producthasbeeninspectedforqualityandcanbeeffectiveforcertainindications,butfinaldecisionsandongoingmonitoringmustbemadebythe

prostheticprofessional(s)prescribingand/orfittingthedevicetodetermineitseffectivenessforanindividualpatient.Patientcomplianceisan

integralpartoftheentireprotocolandmustbeadheredtoinordertoavoidpotentialproblemsandtomaximizetheeffectivenessofthe

prescribedproduct.

AsaconditionofthesaleofanyTrulifeproduct,thisprosthesisisrestrictedtoa“SinglePatientUseOnly”bytheoriginallyfittedpatientinorderto

protectthecareproviderandthepatientagainstpotentiallyadverseconsequencesofinfectiousdiseasetransmission,materialinstabilityin

adaptingtotheconfigurationoftheoriginaluserand/ordecreaseineffectivity.Anyexpressorimpliedwarrantiesarevoidediftheproductis

reusedorfittedtoanotherpatient.Additionally,alicenseofrighttouseunderanyrelevantpatentspertainingtotheproductisterminatedwith

thecessationofusebytheoriginalpatient.AswithallTrulifeproducts,thisproductmustbeprescribedandappliedbyaqualifiedpractitionerto