I n s t r u c t i o n s f o r u s e
UnloaderOneOTS&Custom
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Instructions for use................................................5Gebrauchsanweisung.............................................8Guidedefabrication...............................................11Instruccionesparaeluso.......................................14Istruzioniperluso.................................................17Bruksanvisning.......................................................20Brugsanvisning.......................................................23Bruksanvisning.......................................................26Kyttohjeet............................................................29Gebruiksaanwijzing................................................32InstruesdeUtilizao.........................................35.............................................................38 .............................................................41 ............................................................43
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EN- Caution:Thisproducthasbeendesignedandtestedbasedonsinglepatientusage.Itisasingle-usedeviceandshouldneverbeusedbymultiplepatients.Ifanyproblemsoccurwiththeuseofthisproduct,immediatelycontactyourmedicalprofessional.
DE- Zur Beachtung:DiesesProduktistfrdieAnwendungbeieinunddemselbenPatientenvorgesehenundgeprft.DerEinsatzfrmehrerePatientenwirdnichtempfohlen.WennbeimTragendiesesProduktsProblemeauftreten,sofortdenArztverstndigen.
FR- Attention:Ceproduitatconuettestpourtreutilisparunpatientuniqueetn'estpasprconispourtreutilisparplusieurspa-tients.Encasdeproblmelorsdel'utilisationdeceproduit,contactezimmdiatementunprofessionneldesant.
ES- Atencin:Esteproductosehadiseadoyprobadoparasuusoenunpacientenicoynoserecomiendaparaelusodevariospacientes.Encasodequesurjaalgnproblemaconelusoesteproducto,pngaseinmediatamenteencontactoconsuprofesionalmdico.
IT- Avvertenza:Questoprodottostatoprogettatoecollaudatoperessereutilizzatoperunsingolopazienteesenesconsiglial'impiegoperpipazienti.Incasodiproblemidurantel'utilizzodelprodotto,contat-tareimmediatamenteilmedicodifiducia.
DA- Forsigtig:Detteprodukterberegnetogafprvettilatblivebrugtafnpatient.Detfrardesatbrugeproduktettilflerepatienter.Kontaktdinfysioterapeutellerlge,hvisderopstrproblemeriforbindelsemedanvendelsenafdetteprodukt.
SV- Var frsiktig:Produktenharutformatsochtestatsbaseratpanvn-dningavenenskildpatientochrekommenderasintefranvndningavflerapatienter.Omdetskulleuppstproblemvidanvndningavproduktenskaduomedelbartkontaktadinlkare.
NL- Opgelet:Ditproductisontworpenengetestvooreenmaliggebruik.Hergebruikvanditproductwordtafgeraden.Neembijproblemenmetditproductcontactopmetuwmedischezorgverlener.
PT- Ateno:Esteprodutofoiconcebidoetestadocombasenauti-lizaonumnicodoenteenoestrecomendadoparautilizaoemmltiplosdoentes.Casoocorraalgumproblemacomautilizaodesteproduto,entreimediatamenteemcontactocomoseuprofissionaldesade.
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ENGLISH(Figure 1)A. Dynamic Force Control System (Upper DFS) B. Lower Dynamic Force Strap C. Thigh Strap D. Calf StrapE. Polycentric hingeF. Thigh ShellG. Calf ShellH. Quick Fit BuckleI. Buckle-stability PinJ. Alligator Clip
UNLOADER ONE INDICATION FOR USE: MildtoSevereUnicompartmentalOsteoarthritis Unicompartmentalkneeconditionsthatrequireloadreductionto
affectedcompartmentsuchas: Articularcartilagedefectrepair Meniscalcartilagerepair Avascularnecrosis Tibiaplateaufracture
Normalactivitiesofdailyliving Circumferencelimitation
Thighcircumferencessmallerthan13.5"(34.3cm)orbigger than29"(73.5cm).
Calfcircumferencessmallerthan10"(25cm)orlargerthan 24"(61.5cm).
CAUTION:Forpatientswithperipheralvasculardisease,neuropathy,andsensitiveskin,closephysiciansupervisionisrecommended.
TheUnloaderOnepainreliefdeviceisfieldadaptabletoaccommodatepatientcomfortissues.Modificationstoflexionorextensionstopsandshellcontourshouldonlybemadebythehealthcareprofessional.ThehealthcareprofessionalisresponsibleforadvisingpatientonuseoftheDynamic Force Control System system.
NOTE:Havepatientwearbraceforafewminutestomakesurestrapsare at comfortable tension.
DONNING BRACE1. Alignbraceonpatientslegwithcenterofhingeatmidpatellaand
midlineofa/pplane(Figure 1).2. With both Quick Fit Buckles open - place button of lower Quick Fit
Buckleintoappropriatekeyholeabovebuckle-stabilitypin(Figure 2)andclosecarefully(Figure 3).Thebuttonisnowcolormatchedwithanidenticalbluecolorswatchinthekeyholeforintuitivestrapselection.
3. Bendkneetoan80angle-footflatonfloor.4. Place button of upper Quick Fit Buckle into appropriate keyhole
(yellow)andclosecarefully.5. TightenDynamicForceControlSystemtoaprescribedposition
(Figure 4):Practitionerwillneedtodetermineoptimumunloadingbasedonpatientspainrelieffeedbackbutinitialsettingisrecommendedat5.
6. Fullyextendleginasittingpositionandmakesurethatbraceisstillalignedcorrectlyonleg.
7. Ensurestrappadisnotwrinkledandispositionedunderstrapcrossinginpopliteal.QuickFitBucklesmayhavetobeopenedtorelievestraptensionandallowpositioningofstrappadonnon-ratchetedDFSstrap(Figure 13).
8. Ifpatientrequiresmoreorlessunloading,adjustthetensionofupperDFSstrapaccordinglywithDynamicForceControlSystemand/orlowerDFSstrapbyadjustinglengthatthighQuickFitBuckle.
9. IfDynamicForceControlSystemhasbeenpulledtoitsmaximumandpatientrequiresmorepainrelief,DFSstrapsneedtobeshortenedaccordinglyonlowerQuickFitBuckle.
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10.Keyholelocksmaybeinsertedintocalfandthighshells(Figure 5) ifdesiredtoensurestrapscannotaccidentallybedisengagedfromshells.
NOTE:Havepatientwearbraceforafewminutestomakesurestrapsareatcomfortabletension.Pressurereducingpadsareincludedandmaybeappliedforadditionalcomfort.
REMOVING BRACE1. PressbuttononDynamicForceControlSystemtoreleasetensionin
ratcheted-DFSstrap(Figure 6).2. OpenbothupperandlowerQuickFitBuckle3. RemoveQuickFitBucklesfromkeyholes4. Removebracefromleg
ONE-TIME STRAP LENGTH ADJUSTMENT (OPTIONAL):1. Removealligatorclips(J)andtrimstraps.DFSAlligatorclipsshould
bepositionednearbytobuckles(Figure 7) away from popliteal region.
2. Repeatforallstraps.
TAMPER PROOF STRAP LENGTH SET-UP:Thebracenowshipswithstrapsfoldedexternallyontothemselvesforeasyadjustment.Ifdesired,thestrapsmaybereversedandfoldedinaninternalterminationforatamperproofpatientconfiguration:
1. Removealligatorclips.2. PullstrapoutofD-ring/buckleandthreadthroughD-ring/buckleina
reversedmanner,fromoutsidetoinside(Figure 8) . 3. Usedoublesidedhookprovidedtosecurestrapend(Figure 8).4.Repeatforallstraps.
RANGE OF MOTION ADJUSTMENT (ROM): Thedevicecomeswitha0extensionstopinstalled.Additionalextensionstopsof5,10,15and30havebeenprovided.Aflexionstopsof90isalsoincluded.
NOTE:Optimalcorrectiveforcesareappliedatfullextension.Ifpatientrequiresanextensionstopchange,makesuretoreadjusttensioninDFSstrapsifmoreunloadingisrequired.
TO CHANGE RANGE OF MOTION:1. Peelcondylepadfromhingetoexposescrew.2. Removeretainingscrew.3. Slide0stopoutofhinge.4. Insertdesiredextensionstop.5. Securewithretainingscrew(DONOTOVERTIGHTEN)6. Foraddingflexionstop,followsteps1,4&5.
FINAL INSPECTION: RightlegbraceFigure 9. FrontFigure10.MedialsideFigure11.LateralsideFigure12. Back
BRACE MAINTENANCEUnloaderOnepainreliefdeviceisdesignedforminimummaintenanceandcare.Followtheseeasymaintenancestepstokeepbraceingoodcondition.
CLEANING Linersmaybewipeddowninplacewithalcoholforaquickcleaning. Formorethoroughcleaning,liners,strapsandstrappadsmaybe
removed. DONOTMACHINEWASH. DONOTPLACEINDRYER Hand-washusingmildnon-detergentsoap. Rinsethoroughly.
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Air-dry. StrappingSequence(Figure 13). Quickfitbuttons,buckles,andshellshavenowbeenlabeledwith matching symbols to ease reassembly (Figures 14 and 15).
Ifmigrationoccurs,cleanlinerswithanalcoholwipeordampcloth.
HINGE Forsafetyreasons,hingeshouldonlybedisassembledbyahealth
care professional. Checkregularlyforforeignmaterialsinhingei.e.(dirtorgrass). Cleandirtfromhingeusingtapwaterorcompressedair.
Ifbraceisusedinsaltwaterorchlorinatedwater,rinsewellandairdrybrace.Aregularserviceroutinewillensurehinge,liners,strapsandpadsareinoptimumworkingorder.
BRACE ACCESSORIESssuroffersaccessoriesthatmeetspecificneedsoftheUnloader One.TheseaccessoriescanbepurchasedthroughthebraceproviderorssurCustomerServiceDepartments. ExtraSetofLiners ReplacementStraps Strappads UndersleevesareNOTrecommended Antimigrationstrap
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DEUTSCH(Abbildung 1)A. Dynamic Force Control System (oberer DFS)B. Unterer Dynamic Force StrapC. OberschenkelgurtD. WadengurtE. PolyzentrischesScharnierF. OberschenkelschaleG. WadenschaleH. SchnellverschlussschnalleI. SchnallenstabilisierungsnadelJ. Alligatorklemme
UNLOADER ONE ANWENDUNGSGEBIETE: LeichtebisschwereunikompartimentelleArthrose UnikompartimentelleKnieerkrankungen,dieeineEntlastungdes
betreffendenKompartimentserfordern,wiebeispielsweise: Gelenkknorpelplastik Meniskus-Rekonstruktion Osteonekrose Tibiakopf-Fraktur
NormaleAlltagsaktivitten EinschrnkungdesUmfangs
Schenkelumfangunter34,3cmoderber73,5cm Wadenumfangunter25cmoderber61,5cm
ACHTUNG: BeiPatientenmitperipherenGeferkrankungen,NeuropathieundempfindlicherHautwirdeinestndigerztlicheberwachung empfohlen.
DieOrtheseUnloaderOnezurSchmerzlinderunglsstsichdankverschiedenerEinstellmglichkeitenkomfortabelandenPatientenan
