genium x3 - bionic prosthetic system

Genium X3 - Bionic Prosthetic System3B5-X3/3B5-X3=ST

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Ottobock | 3GeniumX3-BionicProstheticSystem

INFORMATION

Lastupdate:16October2013• Pleasereadthisdocumentcarefully�• Followthesafetyinstructionsandtheprecautionsspecifiedinthisaccompanyingdocument�• Please contact the responsible prosthetist if assistance is required during the start-up, use or

maintenanceoftheproduct,orintheeventofunexpectedoperatingbehaviourorcircumstances�

Explanation of symbols DANGER Warningsregardingdirectlyimpendingrisksofsevereaccidentorinjury�

WARNING Warningsregardingpossiblerisksofsevereaccidentorinjury�

CAUTION Warningsregardingpossiblerisksofaccidentorinjury�NOTICE Warningsregardingpossibletechnicaldamage�

ApplicationINFORMATION

BeforeusingtheGeniumX3kneejoint,pleasereadtheseinstructionsforusethoroughly!Pleasefollowyourprosthetist'sdirectionsandobservethesafetyinstructionscarefully�

TheGeniumX3kneejointisintendedexclusivelyforexoprostheticfittingsofthelowerextremity�

Conditions of UseTheGeniumX3wasdesignedforbroadfieldofapplicationandcanbeusedbytransfemoralam-puteesaswellasbyactivehipdisarticulationamputees�Forkneedisarticulationamputees,aver-sionforlongresiduallimbsisavailable(3B5-X3=ST)�PleaseseetheTechnicalInformationsectionforthepermissibleenvironmentalconditions�TheGeniumX3kneejointisintendedexclusivelyforfittingsofamputeesordysmeliapatients�Useoftheproductbyotherpersonsisnotapprovedbythemanufacturer�

FunctionTheGeniumX3kneejointisanelectronickneejointsystemwithhydraulicstanceandswingphasecontrol�Itiscontrolledbyamicroprocessor-basedhydraulicsystemthatdynamicallyadaptsthesysteminrealtime�Thecontrolmechanismworksinconjunctionwithasensorsystem�Thesensorscollectmeasurementsevery0�01seconds(correspondsto100Hz)�ThisallowstheGeniumX3toadaptinrealtimetotheindividualrequirementsandtheactivitiesoftheprosthesiswearer�Additionalmymodespermitactivitiessuchascycling,cross-countryskiingorinlineskating�

Safety Instructions CAUTION

Non-observance of safety instructions.Failuretoobservethesafetyinstructionsandprecau-tionsdescribedinthisaccompanyingdocumentcanleadtofaultycontrolormalfunctionoftheproductandmayresultinriskofinjuryaswellasdestructionoftheproduct�

4 | Ottobock GeniumX3-BionicProstheticSystem

CAUTION

Use of unsuitable prosthetic components.Ifunsuitableprostheticcomponentsareinstalledintheprosthesis,malfunctionofthekneejointandalossoffunctionalityduetostructuralfailuremayoccur�Thiscancauseyoutofall�ThekneejointmayonlybecombinedwithadaptersandfeetapprovedbyOttobock�Ottobockassumesnoliabilityifthekneejointisusedwithprostheticfeetotherthanthosespecified�

CAUTION

Manipulation of system components.Independentchangesand/ormodificationsofsystemcomponentsmayleadtomalfunctionofthekneejointandalossoffunctionalityduetostructuralfailure�Thiscancauseyoutofall�• Anychangesormodificationstothekneejointmaylimititsusability�• OpeningandrepairingofthekneejointmayonlybeperformedbyauthorisedOttobockpersonnel

andthehandlingofthebatterymayonlybecarriedoutbyOttobockServiceCentres(independentreplacementisnotpermitted)�Pleasecontactyourprosthetistifyouhaveanyservicequestions�

CAUTION

Improper use of theremotecontrol�Improperusemaydamagetheremotecontrol�Thiscanleadtomalfunctionoftheremotecontrolandresultinunexpectedactionsofthekneejoint�Thiscancauseyoutofall�Pleaseobservetheinformationontheproperuseoftheremotecontrolintheremotecontrolsection�

CAUTION

Transport damage.Mechanicalimpactsorstressduringtransportationofthekneejoint,suchasshocksandvibrations,canleadto:• Defectsandresultingmalfunctionsofthekneejoint�• Batteryandhydraulicunitdamageresultinginleaks�• Lossoffunctionalityduetostructuralfailure�Thiscancauseyoutofalland/orresultinskinirritation�Forthepurposeoftransportation,usethepackaginginwhichthekneejointwasdelivered�

CAUTION

Magnetic interference.Thekneejointcanmalfunctionwhennearhigh-voltagepowerlines,transmitters,transformers,CTscannersorothersourcesofstrongelectromagneticradiation(suchassecuritysystemsforgoodsindeapartmentstoresorbodyscannersinairportareas)�Thismaycausetofall�Avoidproximitytostrongsourcesofmagneticandelectricinterference(e�g�transformerstations,transmitters)�Ifthiscannotbeavoided,careatleasttogoorrathertostandsecurely(e�g�bymeansofhandrailorthesupportofaperson)�

CAUTION

Thermal overloading.Extendedexposuretohightemperaturescanleadtodefectsandresultinmalfunctionsofthekneejointwithalossoffunctionalityduetostructuralfailure�Thiscancauseyoutofall�Avoidareaswithextremetemperatures(seethe"TechnicalInformation"section)�


CAUTION

Mechanical overloading.Exteriormechanicalimpactsorstresssuchasshocksandvibrationscanleadto:• Shortcircuitsintheelectronicsandbattery,resultinginmalfunctionofthekneejoint�• Defectsofthebatteryandthehydraulicunit,resultinginleaks�• Lossoffunctionalityduetostructuralfailure�Thiscancauseyoutofalland/orresultinskinirritation�Donotexposesystemcomponentstomechanicalvibrationsorshocks�

CAUTION

Penetration of dirt and humidity.Penetrationofdirtandhumidityintothesystemcomponentscanleadto:• Shortcircuitsintheelectronicsandbattery,resultinginmalfunctionsofthekneejoint�• Hydraulicunitdefectswithanassociatedleakageoffluidoralossoffunctionalityduetostructural

failure�Thismaycausethepatienttofalland/orresultinskinirritation�• Ensurethatnoparticlescanpenetratethesystemcomponents�• ThekneejointandtheAXONtubeadapterarewaterproof�Theymustnotbeusedunderextreme

conditionslikedivingorjumpingintothewaterandarenotintendedtobeusedunderwaterper-manently�

• Afterusingthekneejointinasaltwaterenvironment,removetheprotector,rinsekneejointandprotectorwithfreshwaterandletthemdry�

• Shouldthekneejointcomeintocontactwithsolutionsotherthanfreshorsaltwater,itmustberinsedwithfreshwaterimmediately(alsothesectionCleaningandCare)�

• Thekneejointisnotresistantagainstpenetrationwithwaterjetsorsteam�• Ifthereisawaterleakageintotheelectronicsystem,thekneejointmustbesenttoanauthorised

OttobockServiceCentreforinspection�Pleasecontactyourprosthetist�

CAUTION

Improper use of the knee joint.Anykindofoverloadingorexcessivestrainaswellasimproperusecanleadto:• Defectsandresultingmalfunctionsofthekneejoint• Lossoffunctionalityduetostructuralfailure• Defectsofthebatteryandthehydraulicunit,resultinginleaksThiscancauseyoutofalland/orresultinskinirritation�Thekneejointwasdevelopedforeverydayuse�Misuseandabuseisnotcoveredunderwarranty�Carefulhandlingoftheprosthesisanditscomponentsnotonlyincreasestheirservicelifebut,aboveall,ensuresyourpersonalsafety�Shouldtheprosthesisbesubjectedtoextremestrain(e�g�byfallingorsimilar),itmustbeinspectedforpossibledamagebyaprosthetistimmediately�Ifnecessary,theresponsibleprosthetistwillpasstheprosthesisontoOttobockService�


CAUTION

Overheating of the hydraulic unit�Extended,continuoususe(e�g�lengthydownhillwalks)canleadto:• Overheatingofthehydraulicunitresultinginmalfunctionofthekneejoint• DefectsofthehydraulicunitresultinginleakageofliquidThiscancauseyoutofalland/orresultinskinirritation�Touchingoverheatedcomponentscanalsocauseburns�Pleasetakenoteofpulsatingvibrationsignals�Theyindicatetheriskofoverheating�Assoonasthesepulsatingvibrationsbegin,stopallactivitiesandallowthehydraulicunittocooldown�Youmayresumeyouractivitiesoncethepulsatingvibrationsignalsstop�Ifactivitiesarecontinueddespitethepulsatingvibrationsignals,thereistheriskofoverheatingthehydraulicelementand,inextremecases,ofdamagetothekneejoint�ThekneejointshouldthenbesenttoanauthorisedOttobockServiceCentreforinspection�Pleasecontactyourprosthetistwithanyservicequestions�

CAUTION

Danger of falling when descending stairs.• Whenwalkingdownstairs,thebanisterorhandrailshouldalwaysbeusedandtheprostheticfoot

shouldbeplacedonthestepsothattheheel(max�centreofthefoot)isclosetotheedgeofthesteptofacilitaterollover�

• Iftheaudiblesignalsounds,stopdescendingimmediatelyandcheckwhetherstancephasecon-trolisactive(seeSection“SafetyMessagesandSafetyMode“)�

• Observethevibrationandaudiblesignals(beeps)ofthekneejoint�• Particularcautionisrequiredwhencarryingchildrendownstairs�

CAUTION

Improper MyMode switching.IncorrectlyswitchingfromMyModesintobasicmodeorviceversaresultsinariskoffalling(seethesectionMyModeSwitchingviaremotecontrol)!• AfterswitchingtooneoftheMyModes,checkthefunctionssinceyoumayhaveaccidentallyactiva-

tedadifferentMyModethanyouintended(seethesection„MyModeSwitchingwithouttheremotecontrol“andthesection„MyModeSwitchingwiththeremotecontrol“)

• EnsurethatyouswitchbacktobasicmodeonceyouractivitiesintheMyModehaveended�

CAUTION

MyMode Switching via remote control.Youcanusetheremotecontroltoinitiatevariousac-tionswhichcausethedampingbehaviourofthekneejointtochange�Incertainsituations,thiscancauseyoutofall�Ifanunintendedactionwasaccidentallyinitiatedusingtheremotecontrol(feedbackintheformofavibrationoraudiblesignal),takeyourweightoffthekneejointandswitchbacktotheintendedmode�

CAUTION

Consequences of product deterioration.Wearandtearonsystemcomponentscanleadtomalfunctionofthekneejoint�Thiscancauseyoutofall�Foryourownsafety,complywiththespecifiedserviceandinspectionintervals(maintainingopera-tionalsafetyandprotectingthewarranty)�Pleasecontactyourprosthetistwithanyservicequestions�


WARNING

Danger of accidents when operating a motor vehicle.Theabilityoflegprosthesiswearerstooperateamotorvehicleisdeterminedonacase-by-casebasis�Criteriaincludethetypeoffitting(amputationheight,unilateralorbilateral,residuallimbconditions,designoftheprosthesis)andtheindividualabilitiesofthelegprosthesiswearer�Ensureyouobservetheapplicablenationallawsfortheoperationofmotorvehiclesandhaveyourdrivingabilityexaminedandcertifiedbyanauthorisedagencyforinsurancepurposes�Ingeneral,Ottobockrecommendsthatvehiclesshouldbeprofessionallyretrofittedtomeeteachuser’sindividualneeds(e�g�automatictransmission)�Risk-freedrivingmustbeensuredevenwhenthelegprosthesisisnotfunctioning�

CAUTION

Malfunction of the knee joint.Malfunctionsofthekneejointcancauseyoutofall�Observethevibrationsignalsandaudiblewarnings(beepsignals)ofthekneejoint�

CAUTION

Non-active safety mode.Ifsafetymodecannolongerbeactivated,thereisariskoffalling�Ifthekneejointisnolongerabletoselectsafetymode(e�g�incaseofshortcircuitcausedbywaterpenetration),thekneejointmayhavetobeactivelysecureduponheelimpactusingtheresiduallimbmusculatureuntilreachingaprosthetistorreplacingtheprosthesis�Inthiscase,theprosthet-istmustbecontactedpromptly�

CAUTION

Risk of pinching in the flexion range area of the joint.Keepfingers/bodypartsawayfromthisareawhenflexingthejoint�

CAUTION

Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi devices).Unexpectedprosthesisbehaviourduetointerferencewithinternaldatacommuni-cation�Incertainsituations,thiscancausetheusertofall�Therefore,maintainthefollowingminimumdistancefromtheseHFcommunicationdevices:• MobilephoneGSM850/GSM900:0�99m• MobilephoneGSM1800/GSM1900/UMTS:0�7m• DECTcordlessphonesincl�basestation:0�35m• WiFi(routers,accesspoints,…):0�22m• Bluetoothdevices(third-partyproductsnotapprovedbyOttobock):0�22m

INFORMATION

Theseproductsmaynotbedisposedofwithhouseholdwasteinsomejurisdictions�Disposalthatisnotinaccordancewiththeregulationsofyourcountrymayhaveadetri-mentalimpactonhealthandtheenvironment�Pleaseobservetheinformationprovidedbytheresponsibleauthoritiesinyourcountryregardingreturnandcollectionprocesses�


Charging the knee jointINFORMATION

Chargingthekneecompletelybeforeuseisstronglyrecommended�

INFORMATION

Chargingthebatteryisonlypossibleattemperaturesover0°C�Fullychargingthebatteryinthekneejointtakesapprox�6-8hours�Thebettertheconnectionbetweenthechargerandreceiveronthekneejoint(notinterruptede�g�byasock),theshorterthechargingtime�

CAUTION

Charging the prosthesis without taking it off.Duringchargingoftheprosthesisthedamp-ingcharacteristicsofthekneejointchangebecausetheadjustablesafetymodeisactivated�Incertainsituations,thiscancausetheusertofall�Forsafetyreasons,taketheprosthesisoffbeforechargingthebattery�

1 2a 2b 3Connectthepowercordtothechargerwiththecorrectpolarity(Figure1)�1� Starttheinductivechargingprocessbyconnectingthechargertothereceiveronthebackofthe

kneejoint�Thechargerisheldinplacebyamagnet(Figure2a/2b)�VerifythebatterycapacityusingtheLEDsontheside(Figure3)andthechargingprocessbasedonthecolouroftheillu-minatedring(Figure2b)(seetablesbelow)�

2� Endtheinductivechargingprocessbydisconnectingthechargerfromthereceiver�Thekneejointperformsaself-testandisthenreadyforoperation,provideditisconnectedtotheAXONTubeAdapter�Thisisindicatedbyasinglevibrationsignalandbeep�Ifthisisnotthecase,anerrorhasoccurred�InthatcasepleasesendthekneejointtoyourprosthetistoranauthorisedOttobockServiceCentre�

INFORMATION

Afterdisconnectingthechargerthekneejointwillconductaselftest�Besurenottomovethekneejointduringthisbriefselftest,sinceitcancauseanerror�Ifyouencounterthiserror,theproblemcanbecorrectedbyreconnectingandthendisconnectingthecharger�

INFORMATION

Chargingisnotpossibleifthedistancebetweenthetransmitterandreceiverisgreaterthan2mm�However,chargingshouldproceednormallyif,forexample,asockorSuperskinbetweentransmitterandreceiverofthecharger(alsoseetheChargingProcesstable)�

Battery capacity indicator on the battery charger (Figure. 3):

LEDs 0 1 2 3 4 5Batterycapacity 0–10% 10–30% 30–50% 50–70% 70–90% >90%


Charging Process TableStatus StatusLED BatterycapacityindicatorThepowersupplyisconnected,butthechargerisnotattachedtothekneejoint

Continuousgreen AllfiveLEDsoff

Chargerconnectedtokneejoint,goodconnection

Purplepulsing(4-secondcycle)*

Displayofthebatterycapacity(green)accordingtothenumberofilluminatedLEDs

Chargerconnectedtokneejoint,badconnection

Weakpurple*

Displayofthebatterycapacity(green)accordingtothenumberofilluminatedLEDs

a)Chargerexcesstemperatureb)Jointexcess/insufficienttemperaturec)Connectionmaybeimprovedbyreduc-ingthedistancebetweenthechargerandreceiver

Continuousyellow�Thejointisnotcharged�

a)2ndand4thLEDilluminateda)1st,3rdand5thLEDil-luminatedc)3rdLEDilluminated(seethesectionChargingthekneejoint,Figure3)

Chargerfault(errorcorrectionbydiscon-nectingandreconnectingthepowersupplymaybepossible)

Flashingred�Thejointisnotcharged�

LEDsindicateanerrorcode�

*Thisdisplayturnsoffautomaticallyafterapprox�oneminutetoavoidbothersomelightatnight�Thechargingprocessisnotaffected�Thechargingstatusofthekneejointisalsoshownonthedisplayoftheremotecontrol�Inaddition,theremainingoperatingtimeisindicatedtotheuserbykneejointvibrationsignalsoncetheremainingbatterycapacityreachesapprox�25%(seetablebelow)�

Vibrationsignalofthekneejoint BatteryCapacity RemainingOperatingTime3 xvibration 25 % approx�24hours5 xvibration 10 % approx�6hours

10 xvibrationandbeeping 5 % 0hours

CAUTION

Feedback is disabled in mute mode.Whenthemutemodeisactive,allvibrationandbeepsignalsaredisabledandthekneejointwillgointolowbatterymodewithoutanywarning!Ifun-expected,thiscancauseyoutofall�Beawareofthisfactbeforeactivatingthemutemode�


INFORMATION

Whenthekneejointisfullycharged(all5LEDsatthesidelightup(Fig�3)),themaximumperiodofuseforthekneejointbeforethenextchargingprocessisupto5days,dependingonpatientactivity�However,werecommendchargingthekneejointeverynight�

Functions in the Basic ModeINFORMATION

Yourprothetistcanactivate/deactivatesettingsusingtheX-Softconfigurationsoftware�

Sitting functionWhenasittingpositionismaintainedformorethantwoseconds(i�e�thethighisclosetohorizontalandthereisnoloadontheleg),thekneejointswitchestheresistancetoaminimuminboththeflexionandextensiondirections�ThesittingfunctioncanbeactivatedbytheprosthetistbyusingtheX-Softadjustmentsoftware�

INFORMATION

Whilesitting,thekneejointswitchestoanenergy-savingmode�Thisenergy-savingmodeisacti-vatedregardlessofwhethertheSittingfunctionhasbeenenabledornot�

Intuitive Stance functionTheIntuitiveStancefunctionautomaticallyrecognisesanysituationthatputsstrainontheprosthesisintheflexiondirectionbutwhereflexionisnotpermitted�Exampleswherethisisthecaseincludestandingonunevenorslopingsurfaces�Thejointisalwayslockedintheflexiondirectionwhentheprostheticlegisnotfullyextended,undersomeamountofloadandatrest�Whentheloadistakenoffthelegoruponforwardorbackwardrollover,thelevelofresistanceisimmediatelyreducedtostancephaseresistanceagain�Thekneejointisnotlockedwhentheaboveconditionsaremetandasittingpositionisassumed(forexamplewhiledriving)�TheIntuitiveStancefunctioncanbeactivatedbytheprosthetistbyusingtheX-Softconfigurationsoftware�

Stairs and Obstacles function

Negotiating stairs step-over-step:

AlthoughtheGeniumX3isapassivekneejoint,whichmeansitcannotactivelyinitiatemovements,negotiatingstairsstep-over-stepispossible�Inordertodoso,theprostheticfoothastobeplacedonthenexthigherstepfirstwiththekneeflexed�Thenthehipisextended,whichalsoextendstheknee�Thisrequiresasufficientlysecureholdinthesocketandacertainlevelofresiduallimbstrength�Duringphysiologicalstairclimbing,kneeflexionisaccomplishedbyactivelyraisingthelowerpartoftheleg�Withkneejoint,kneeflexioncan


beachievedviathemassinertiaofthelowerpartoftheleg�Immediatelyafterliftingtheextendedlegoffthefloor,simultaneouslyextendthehipbrieflyandthenabruptlyflexit�Thiswhipactionflexestheknee�Thekneejointrecognisesthismovementsequenceandsetsflexionresistancetominimum�Withoutactivationofthismode-i�e�withstancephaseresistance-kneeflexionwouldbelimitedandunpleasantpressurewouldbefeltontheresiduallimb�Themovementpatternisverysimilartothephysiologicalprocessifthetoesextendbelowthenexthigherstepatthebeginningofthecycle�Here,too,theheelhastobepulledbackfirst�Practicethe“toesunderthestep”movementpatternwiththesoundsideandwiththeprosthesis;thenthecompletemovementpatternisintuitiveandeasytolearn�Whensufficientkneeflexionhasbeenachieved,thekneejointincreasesextensionresistancesothatthereisenoughtimetopositionthefootonthenextstepbeforethekneejointisextendedagain�Thesupportingareaforthefootonthestephastobesufficientsothattheheeldoesnotextendbacktoofarovertheedge�Withtoolittlesupportarea,thelowerlegwouldextendtooearlyandpositionthelegtoofarbackwards�Inthisphase,thekneejointhasalreadymaximisedtheflexionresistance(thatis,furtherflexionisblocked)�Thekneejointcannolongerbeflexedbutonlyextended�Thisensuresthatthelegdoesnotbuckleifthehipstrengthisnotsufficientfortheextendingmotion�Supportyourselfwithyourhandonthecontralateralside�Asmoothwallisalsosufficientforthispurpose�Thislateralsupportisintendedtopreventtheresiduallimbfromtwistinginthesocket�Twistingcanleadtounpleasantsurfacetensionbetweentheskinandthesocket�Lateralsupportalsoimprovesyourbalance�Whenthekneejointisfullyextended,theinitialpositionhasbeenreached�Youcanclimbthenextsteporcontinuewalkingnormally�Crossing obstacles:Thestairsandobstaclesfunctioncanbeusedtocrossobstacles�Insteadofachievingtherequiredgroundclearanceoftheprostheticfootthroughlateralabductionoftheextendedleg,thewhipactiondescribedabovecanbeused�Thisisalsopossiblefromthewalkingmotion�Taketheweightofftheprostheticlegwhenthekneejointisextendedandthenperformthewhipmotion,whichswitchesthekneejointtothestairandobstaclefunction�Thisdelaystheextensionmovement,givingenoughtimeandgroundclearancetostepoveranobstacle�Theprostheticlegwillnotbefullyextendeduponheelimpact�Anactivekneejointwouldberequiredtoachievethis�Sincethekneejointislockedintheflexiondirectionduringthisphase,puttingweightonitdoesnotposeahazard�Youcanthenresumewalkingnormally�Thestairsandobstaclesfunc-tioncanbeactivatedbytheprosthetistusingtheX-Softconfigurationsoftware�Optimized Physiological Gait (OPG) functionOPGminimizestheX3user’sprostheticdeviationsandpromotesamorebiomechanicallycorrectgaitpattern�TherearenoinitiationorexitstrategiesthatapplytoOPG-itsimplyhappensduringthecourseofnormalwalking�Selectionofthisfunctionenablesthefollowingfeatures:(1)PreFlex(2)AdaptiveYieldingControl(3)DynamicStabilityControl(DSC)(4)StanceReleaseonRamps,and(5)AdaptiveSwingPhaseControl�AdaptiveSwingPhaseControlandDSCareenabledevenifOPGisnotactivated�OPG Features(1) PreFlexPreFlexensuresthekneeisinfourdegreesofflexionattheendofswingphaseinpreparationforloadingresponse�PreFlexallowsuserstowalkwithnaturalstanceflexionindependentofgaitspeed�Theprostheticfootwillalsoreachfootflatmorequicklytopromotestabilityespeciallyonuneven


surfaceswhenPreFlexispresent�PreFlexalsoallowsuserstoascendrampsinamoreanatomicallycorrectwaybyreducingtheneedforuserstovaultoverafullyextendedknee�(2) Adaptive Yielding ControlThekneehasanintelligent,autoadaptivecontrolofstanceflexion(max17°)andextensionmove-ments,dependingontheforcesaffectingthekneesystem�Thevaryingstanceflexionresistanceexperiencedbytheuserise�g�dependentonthebehavioroftheuser,thesurfaceconditionandtheangleofaslopeorincline�(3) Dynamic Stability Control (DSC)DSCensuresthekneewillnotreleasestanceresistanceduringbiomechanicallyunstablestaticanddynamicconditions�Constantlycheckingmultipleparameters,DSCensurestheoptimallytimeddecisionforthekneetosafelyswitchfromstancetoswing�BecauseDSCisalwaysmonitoringkneefunction,multidirectionalmovementandwalkingbackwardarealsopossiblewithoutriskofstanceresistancereleasing�(4) Stance Release on RampsAlthoughflexedandpartiallyloaded-thekneewillreleasestanceonhillsandrampstoallowforgreaterkneeflexion,improvedswingphaseclearance,andlesshipflexionforceneededtobringtheshankintoextension�(5) Adaptive Swing Phase ControlInstantaneousadaptationtovariedwalkingcadencesandtochangesofthependularmass(i�g�varyingfootgear)ensuresthekneealwaysachievestheswingflexiontargetanglewithin(+/-)onedegree�Theswingextensionandflexionresistanceexperiencedbytheuserisautoadaptive�Enabling the OPG function:TheOPGfunctioncanbeactivatedbytheprosthetistusingtheX-Softconfigurationsoftware�Whenthisfunctionisactivated,bothstancephaseextensionandswingphaseextensionareadjustedauto-matically�ThismeansthattheconfigurationsintheseareasarenotnecessaryandthecorrespondingsliderbarsintheSwingphaseandStancephasetabsoftheadjustmentsoftwarearedeactivated�Running function:ThekneejointdetectsatransitionfromwalkingtorunninginBasicmode,andreactsaccordingly�Thekneeautomaticallyprovidesalargerswingflexionangleappropriateforrunningandzeropreflexangleforheelstrike�WheninBasicmode,youhavetoinitiatetherunningfunctionactively�Toinitiatearunningstepitisbesttoexaggeratetheloadingoftheprosthesisforthefirststepsuntilasteadyrunningstateisreached�Thisexaggerationtriggerstherunningfunction�Ittakesalittletraining,untilyoucanusetheRunningfunctioninBasicmode�Additionally,thereisadedicatedrunningmodeavailable,thatyourprosthetistcanconfigureasaMyMode�Inthismode,everystepwillbeperformedasarunningstepwithlargerswingangleandnopreflex�Therunningfunctionwillworkwithspecializedrunningfeetsuchasthe1E90Sprinteraswellaswithprostheticfeetwithaxialcompressionsuchasthe1C61TritonVerticalShock�Feetwithoutaxialcompressionaregenerallynotsuitedforrunning�Fordetailsonhowtousetherunningmodeinconjunctionwithyoufoot,contactyourprosthetist�

MyMode Switching without the remote controlIfswitchingbybouncingwasactivatedintheX-Softconfigurationsoftware,switchingintothefirst


MyModewithouttheremotecontrolisaccomplishedbybouncingontheforefootatleastthreetimeswithinonesecondwhilemaintaininggroundcontactandkeepingtheprostheticlegextended�Indoingso,theforefoothastobearapprox�40%ofthetotalbodyweightatpeakloadandlessthanapprox�25%ofthebodyweightatthelowestload�However,theloadmaynotbetakenoffthefootfully�

1 2 3

3xin1second 1second

Aftertheaudiblesignalisemitted(onelongbeepandalongvibrationsignal),yourweightneedstobetakenofftheprosthesisentirelyforatleastonesecondwiththekneeextended(nogroundcontact)�ThekneejointthenswitchestothefirstMyModeandemitstwoshortBeepandvibrationsignals�TheprocedureforswitchingtothesecondMyModeissimilar,butbybouncingfourtimes�Inthiscase,theswitchisindicatedbythreeshortBeepandvibrationsignals�ReturningtobasicmodefromanyMyModeisaccomplishedbybouncingatleastthreetimes�TheswitchisconfirmedbyashortBeepandvibrationsignal�Ifbouncingthreetimesisactivatedbutbouncingfourtimesisnot,anynumberofbouncesgreaterthanorequalto3switchestothefirstMyMode�

CAUTION

Improper MyMode switching.IncorrectlyswitchingfromMyModesintobasicmoderesultsinariskoffalling(seethesectionMyModeSwitchingviaremotecontrol)!• AfterswitchingtooneoftheMyModes,checkthefunctionssinceyoumayhaveaccidentallyactiva-

tedadifferentMyModethanyouintended(seethesectionsMyModeSwitchingwithouttheremotecontrolandMyModeSwitchingviaremotecontrol)�

• EnsurethatyouswitchbacktobasicmodeonceyouractivitiesintheMyModehaveended�

CAUTION

Feedback is disabled in mute mode.Whenthemutemodeisactive,nofeedbackwillbegivenwhenswitchingintoaMyModeorbacktobasicmode�Ifswitchingwasunsuccessful,thebehav-iourofthekneejointmaybeunexpected�Thismayresultinariskoffalling�Makesurethattheswitchingprocesshasbeensuccessfulbeforecontinuingtousethekneejoint�

INFORMATION

Switchingbacktobasicmodebybouncingthreeormoretimescannotbedeactivated�ThismeansbasicmodewillbeselectedevenifswitchingbybouncingwasnotactivatedintheX-Softconfigurationsoftware�

INFORMATION

Returningtobasicmodeisalsopossiblebyconnectingthebatterycharger�


Remote controlDuringnormaloperation,thekneejointcanbeusedinbasicmode(includingoptionalIntuitiveStancefunction,Sittingfunction,StairsandObstaclesfunction,andOPGfunction)andinuptofivedifferentMyModes�TheMyModescanbeactivatedusingtheremotecontrol�Basicmodeisusedonaday-to-daybasis,whiletheMyModesarepre-programmedforspecificmovementsand/orposturessuchasstandingataworkbench,cycling,inlineskatingorcross-countryskiing�X-SoftisusedtoconfigurewhichMyModesareusedaswellastheirsettings�However,somepa-rameterscanalsobeadjustedwiththeremotecontrol�

CAUTION

Improper MyMode switching using the remote control.MyModeswitchingusingtheremotecontrolchangesthecushioningpropertiesofthekneejoint�Incertainsituations,thiscancauseyoutofall�Youmuststandsecurelywhenswitchingbetweenmodesandmustcarefullyconfirmwhetherthedesiredfunctionwassuccessfullysetbythekneejoint�

CAUTION

Penetration of water into the remote control.Theremotecontrolisnotwaterproof�Underambientconditionswheretheremotecontrolmaygetwet,usingthesupplied4X194ArmBandforprotectionisrecommended�Ifwaterpenetratestheremotecontrol,thedevicemaybedam-aged(warrantywillbecomevoid)�Thiscanleadtomalfunctionoftheremotecontrol,resultinunexpectedactionsofthekneejointandcauseyoutofall�Ifpenetratedbywater,theremotecontrolshouldbedriedatroomtemperatureforatleast1day�Beforeusingtheremotecontrolagain,sendittoanauthorisedOttobockServiceCentre�Pleasecontactyourprosthetistwithanyservicequestions�

CAUTION

Manipulation of the remote control.Anychangesormodificationsyoumaketotheremotecontrolonyourowninitiativecanleadtomalfunctionandresultinunexpectedactionsofthekneejoint�Thiscancauseyoutofall�Anychangesormodificationstothedevicemaylimititsusability�

CAUTION

Unauthorised connection.Ifanunauthorisedconnectionbetweenaremotecontrolandakneejointisestablished,thekneejointcanreactunexpectedly�Thiscanleadyoutofalling�Pairingbetweenthekneeandtheremotecontroldoesnotrequireanypasswordoracknowledgmentfromtheknee�Itisthereforetheoreticallypossible(withknownserialnumberofthekneeorifonlyonekneeiswithinrangeoftheremotecontrol),thatathirdpartyperformspairingwiththekneejointandchangessettingsorswitchesMyModes�

INFORMATION

Thekneejointshouldbeconsciouslykeptmotionlessduringtheswitchingprocess�

INFORMATION

Forsafetyreasons,theremotecontrolautomaticallyturnsoffaftertwominutes�Aftertheremotecontrolisturnedon,approx�threesecondsmayelapsebeforeifisreadyformodeswitchingprocesses�


INFORMATION

Therangeoftheremotecontrolismax�5meter�

Control Elements of the remote control

1

3

4

32

1� LCDscreen2� Enterbutton3� Navigationkeys:Left ,right ,up ,down4� Chargingreceptacle

Initial Connection Between the remote control and the knee joint (Pairing)

1� Turnontheremotecontrolbypressingtheenterbutton�Thestart-upscreenwiththedate,timeandbatterycapacityoftheremotecontrolisdisplayed�Withoutadditionalinput,theremotecontrolturnsoffautomaticallyafter5seconds�

2� Attempttoestablishaconnectionbypressing �Theremotecontrolsearchesforactiveprostheses�3� Whenakneejointisfound(serialnumberisdisplayed),confirmbypressingtheenterbutton�

Ifseveralkneejointsarefound,theserialnumberofthedesiredkneejointhastobeselectedusingthenavigationkeys(display:serialnumber)�Thentheconfigurationdataaredownloadedfromthekneejoint�

INFORMATION

Thisprocesscantakeafewminutes�

4� Themainmenuisdisplayed�Aftertheinitialconnectiontothekneejointhasbeenestablishedsuccessfully,theremotecontrolwillconnectautomaticallyeachtimeitisturnedon(enterbuttonfollowedby )�Nofurtherstepsarerequired�


Status BarThestatusbarshows:1� Batterycapacityoftheremotecontrol2� Chargingstateofthekneejointwithpercentageindicator3� CurrentMyMode4� Incaseofadeviationfromnormalkneejointfunctionality(e�g�

whenthechargerisconnected),anexclamationmarkisshowninthestatusbaratthetopright�ThecurrentMyModeisnotdisplayedinsomeofthesesituations�

MyMode Switching via remote controlOnceanactiveconnectiontotheprosthesishasbeenestablished,theremotecontrolcanbeusedtoswitchbetweenMyModes�

1� Select"Mode"inthemainmenuandconfirmwiththeenterbutton�2� AlistoftheavailableMyModesisdisplayed�Use toselectthedesiredMyModeandconfirm

withtheenterbutton�IfthelistofMyModeswascalledupaccidentally,theactiveMyModecanbeselectedagain�

3� Theremotecontrolcanbeturnedoffbyselectingandconfirming"RCPoweroff"�

Changing Prosthesis SettingsOnceanactiveconnectiontotheprosthesishasbeenestablished,thesettingsoftherespectiveMyModecanbechangedusingtheremotecontrol�

1� Select“Devicesettings”fromthemainmenuandconfirmwiththeenterbutton�2� AlistofavailableparametersforthecurrentMyModeisdisplayed�Selectthedesiredparameter

andconfirmwiththeenterbutton�3� Ascreenwithascale,thecurrentparametervalueandthelimitvaluesisdisplayed�Press

tochangethesettingasrequiredandconfirmwiththeenterbutton�

4� Thelistofparameterscanbeclosedwithoutmakingchangesbyselectingandconfirmingthearrowsymbol�Toselectthearrowsymbol,usetheenterbutton �


5� Theremotecontrolcanbeturnedoffbyselectingandconfirming"RCPoweroff"�InordertochangethesettingsofanotherMyMode,youfirsthavetoswitchtothatMyMode(seethesectionMyModeSwitchingviaremotecontrol)�

INFORMATION

Theprosthetist‘ssettingisusuallyfoundinthemiddleofthescale�Afteradjustment,youcanresettheprosthetist‘ssettingbymovingtheslidercontrolintothemiddle�

INFORMATION

ThekneejointsettingsshouldbeoptimisedbytheprosthetistwiththehelpoftheX-Softconfigura-tionsoftware�Theremotecontrolisnotintendedforusebytheprosthetistinordertosetupthekneejoint�Thebehaviouroftheprosthesiscanbechangedtoacertainextentonaday-to-daybasisusingtheremotecontrol(e�g�whilebecomingaccustomedtotheprosthesis)�Atthenextappointment,theprosthetistcantrackthechangesintheX-Softconfigurationsoftware�

ThetablebelowshowstheadjustmentparametersfortheindividualMyModesalongwithabriefdescription,theadjustmentrangeoftheremotecontrolaroundthevalueselectedbytheprosthetistandtheabsolutevaluerange�

Basic mode

Slider name in X-Soft Absolute Range Remote control Adjustment Range

Description

Stanceflexionresistance 120–180 ±10 Resistancetoflexionmovements,e�g�whilewalkingdownstairsorsittingdowninachair�

Swingphase-flexionangle

55°–70° ±3° Maximumflexionangleintheswingphase�

Pitch 1000Hz–4000Hz

1000Hz–4000Hz

Frequency(pitch)ofthebeeperforconfirmationsignals�

Volume 0–4 0–4 Volumeofthebeeperforconfirmationsignals�

MyModes except friction brake mode

Slider name in X-Soft

Absolute Range Remote control Adjustment Range

Description

Ascent 0–100 ±10 Valueforspeedatwhichflexionresist-anceincreasesasthekneeangleincreases�


1000Hz–4000Hz




Friction brake mode

Slider name in X-Soft Absolute Range Remote control Adjustment Range

Description

Basis 0-180 ±20 Basicresistanceforthekneejointwithoutload


1000Hz–4000Hz



Deep sleep modeTheremotecontrolcanbeusedtoplacethekneejointinadeepsleepmode,inwhichpowercon-sumptionisminimised�Thekneejointoffersnofunctionalityinthismode�Itcanbeawakenedfromdeepsleepmodewiththeremotecontrolorbyconnectingthecharger�Proceedasfollowstoactivatedeepsleepmode:

1� Select„DeviceSettings“inthemainmenuandconfirmtheselection�

2� AlistoftheparametersavailableforthecurrentMyModeisdisplayed�Theentry„Deepsleep“isattheendofthislist;selectitandpresstheenterbutton�

3� Aconfirmationpromptisdisplayed�Presstheenterbuttonagain�Proceedasfollowstowakethekneeusingtheremotecontrol:1� Activatetheremotecontrolbypressingtheenterbuttonand �2� Selectthe“DevicePoweron”menuentryandpresstheenterbuttontoconfirm�3� Thekneejointisreactivatedafternomorethan20seconds,whichisconfirmedbyasinglebeep

andvibrationsignal�Itwillthenbeinbasicmode�

Alternatively,thekneejointcanbewokenbyconnectingthecharger�


Prosthesis Status Inquiry

1� Selectingandconfirming“Status”displaysthefollowing:

• Thetotalpedometervalue(“Step”)• Thedailypedometervalue(“Trip”)• Thebatterycapacityoftheprosthesisinpercent(“Batt�”)• Theestimatedremainingoperatingtimeoftheprosthesisinhoursduringactiveuseandatrest

(e�g�sittingfunction)(„Stb/Act“forStandby/Active)• Thenextserviceduedate

2� Selecting"Trip"andpressingtheselectionkeyresetsthedaystepcounter�

Mute ModeTheremotecontrolcabeusedtosendthekneejointintoamutemode,inwhichallvibrationandbeepsignalsaredisabled�Allotherfunctionsofthekneejointareunaffected�Themutemodecanbedisabledwiththeremotecontrolorbyattachingthecharger�Proceed as follows to activate the Mute mode:1� Select“Status”inthemainmenuandpressentertoconfirm�2� Navigatetotheentry“Mute”andpressentertoconfirm�Todeactivatethemutemoderepeatthisprocedure,orconnecttheCharger�

CAUTION Feedback is disabled.Whenthemutemodeisactive,allvibrationanbeepsignalsaredisabled�Incaseofmodechange,lowbatteryorsystemerrors,themodewillbechanged(orsafetymodeswillbeactivated,respectively)withoutwarnings�Ifunexpected,thiscancauseyoutofall�Beawareofthisfactbeforeactivatingthemutemode�

Remote control Settings

1� Select"RCSettings"inthemainmenuandconfirmusingtheenterbutton�2� Adjustthedateandtimebyselectingthecorrespondingline�Changesettingsusingthenavi-

gationkeys�3� Additionalconnectionscanbesetup(“Pairing”)andconnectionscanbedeleted(“Deletecon-

nection”)(seethesectionProsthesisAdministration)�


4� Thefontsizeinthemenubarcanbechangedbyselecting“Zoom”�

5� � 6� Press onthescreentosetthefonttonormal(1, )orlarge(2, )andthenpresstheenterenterbuttontoconfirm�

7� Informationaboutthefirmwareversionofthekneejointandsignalstrengthisaccessibleunder„Info“�Selectthearrowsymboltoreturntothemainmenuonthedisplay�

Prosthesis AdministrationConnectionswithuptofourdifferentprosthesescanbestoredinasingleremotecontrol�Conversely,aprosthesiscanonlybeconnectedtoasingleremotecontrol�Completethefollowingstepstoaddadditionalconnections:

1� Use toselect"RCSettings"fromthemainmenuandconfirmusingtheenterbutton�2� Select“Pairing”fromthemenuthatappears�3� Theremotecontrolsearchesforadditionalprostheseswithinrange�4� Usetheenterbuttontoconfirmonceanotherprosthesishasbeenfound�Ifseveraladditional

prosthesesarefound,theserialnumberofthedesiredprosthesishastobeselectedusingthenavigationkeys(display:serialnumber)�Use toselectoneofthefourpositionsandconfirmwiththeenterbutton�Oneoftheexistingconnectionscanalsobeoverwritten�Theconfigurationfilesareloadedfromtheprosthesisandthemainmenuisdisplayed�

Todeleteanexistingconnection,pleasefollowthestepsbelow:

1� Use toselect"RCSettings"fromthemainmenuandconfirmusingtheenterbutton�2� Inthemenuthatappears,select"Deleteconnection"andconfirmusingtheenterbutton�3� Selecttheconnectionyouwishtodeleteusing andconfirmwiththeenterbutton�


Connecting to the Prosthesis during Normal OperationIfmorethanoneconnectionhasbeensaved,aselectionmenuforthesavedconnectionsappearsafterpoweringup;themostrecentlyactiveconnectionispre-selectedhere�

1� Tochangetheactiveconnection,selectthenameofthecurrentconnectioninthemainmenuandpressentertoconfirm�

2� Inthelistofsavedconnectionswhichisthendisplayed,selecttherequiredconnectionandpressentertoconfirm�

3� Ifthechosenconnectioncannotbere-established,areducedmainmenuappears�Choose„Selectdevice“toactivateanotherselectedconnection�Insomecasesfollowingservice,theconnectioncannotberestoredeventhoughthejointiswithinrangeoftheremotecontrol�Inthiscase,theexistingconnectionmustbeerasedandthepairingprocesshastobecompletedagain�

Charging the remote controlDisconnectthechargingcablefromthechargerofthekneejointandconnectittothechargingreceptacleontheremotecontrol�Dependingonhowoftentheremotecontrolisused,itshouldlasttwomonthsonasinglecharge�Thebatterycapacityoftheremotecontrolisshownatthetopleftofthedisplay(seeFigure1inthesectionInitialConnectionbetweentheremotecontrolandkneejoint(Pairing))�Fullychargingtheremotecontrolbatterytakesamaximumof3-4hours�


Safety Messages and Safety ModeSymbols used:

shortbeepsignal

longbeepsignal

shortvibrationsignal

longvibrationsignal

Colours used:

Information noactionrequired

Warningactionrequiredsoon

Erroractionrequiredimmediately

Chargingstatus25%3x

Totalfailureorchargingsta-

tus0%

Chargerattachedtokneejoint3x

Hydraulicsystem

overheated1x every

5seconds

Chargingstatus10%5x

Vibration signal

continuous

SelectedMyModeactive

Deepsleepmodeactivated

everyminute

Mediumerror

AXONTubeAdapter

disconnected

Chargingstatus5%

1x

5x

10x

Using the Remote Control

Beep and

vibration signal

1x

Chargerremoved,

self-testOK

1x1x

Minorerror3x3x

5x

10x

30x

Majorerror

5minutes

intermittent(stoppingperiodically)


Type of error Event User restriction Required action

Minor error e�g�serviceintervalhasexpired

Norestriction ConsultProsthetist

Medium error

e�g�asensor(tubeadapter,triplesensor,��)isnotoperating

Walkingpossiblewithrestrictions(activationofsafetymode)

Restartthekneejointbyattachingandremovingin-ductivecharger(uptothreetimes);Iferrorremains,con-sultProsthetistimmediatelySelftestfailure(ifsignals

occurafterremovingthecharger)

AXONTube Adapter disconnected

AXONTubeAdapterhasbeendisconnectedwhilethekneejointisactivatedandtheinductivechargerisnotattached ConnecttheAXONTube

AdapterAXONTubeAdapternotconnectedwhileremovinginductivecharger

Major error

e�g�failureofthevalvedrive• High stance resis-

tance• Swingphasenolon-

gerpossible

Restartthekneejointbyattachingandremovingin-ductivecharger(uptothreetimes);Iferrorremains,con-sultProsthetistimmediately

Selftestfailure(ifsignalsoccurafterremovingthecharger)

Total failureNoelectronicfunctionality

• Activation of safetymode(dependantonthe remaining func-tionality)

• Swingphasenolon-gerpossible

ConsultProsthetistim-mediately

Charging Sta-tus 0%

Chargingrequired

Error code on the display of the Remote Control

ConsultProsthetistimmediately(ErrorCodenumberrequired)

Assoonasthekneejointidentifiesanerrorinthekneejoint,atleast5beepsand5slowpulsatingvibrationsignalsareemitted�Thekneejointactivatesasafetymodeandremainsinthisstateuntiltheerroriscorrected(aslongasthebatterycapacityissufficient)�InadditiontobasicmodeandtheMyModes,thekneejointhasvarioussafetymodesthatofferdif-ferentlevelsofresidualfunctionalitydependingonthetypeandseverityoftheerror�TheOPGfunction,stairsandobstaclesfunction,IntuitiveStancefunctionandSittingfunctionaredeactivatedwhenthejointisinsafetymode�Beyondthat,thefollowinglevelsofresidualfunctional-ityarepossible:• Continuoushighflexionresistance• ContinuousstancephaseflexionresistancewiththeabilitytoinitiatetheswingphaseDependingonthetypeoferror,protectionagainstswingphaseinitiationwhilewalkingbackwardsmayormaynotbeactive�Youmustthereforeexercisecautionwhenwalkingbackwardsafteranerror�


Inaddition,swingphasecontrolandstancephaseextensionresistancemayormaynotbeavailabledependingonthetypeoferror�Ifsafetymodewastriggeredduetoaemptybattery(seeSection“Chargingthekneejoint“),charg-ingtheprosthesisresetsittobasicmode�Inthiscase,theresistancevalueconfiguredintheX-Softadjustmentsoftwareisactivated�Thereisalsoanoverheatingmodetoprotectthekneejointagainstexcessivetemperatures�Inthissafetymode,stancephaseresistanceincreasesasthetemperaturerises–especiallyinordertoslowdownwalkingdownhillsothatoverheatingisnotallowedtoworsen�Swingphasecontrolisalsoprogressivelyreduced�Overheatingmodeisindicatedbybriefvibrationevery5seconds�Basicmodeisreactivatedoncethetemperaturehasfallensufficiently�

CAUTION

Feedback is disabled.Whenthemutemodeisactive,allvibrationanbeepsignalsaredisabled�Incaseoflowbatteryorsystemerrors,thesafetymodeswillbeactivatedwithoutwarnings�Ifunexpected,thiscancauseyoutofall�Beawareofthisfactbeforeactivatingthemutemode�

CAUTION

Non-active safety mode.Ifthesafetymodecannolongerbeactivated,thereistheriskthatyouwillfall�Ifthekneejointcannolongerbesettosafetymode,youmustactivelysecurethekneejointwiththeresiduallimbmusculatureuponheelstrikeandvisitaprosthetistassoonaspossible�

CAUTION

Danger when activating safety mode.Thedampingcharacteristicsofthekneejointchangewhenasafetymodeisactivated�Incertainsituations,thiscancauseyoutofall�Assoonasthesoundandvibrationsignalsareemittedsimultaneously,stopallactivitiesinvolvingthelegprosthesis�Afterapprox�10secondsinasecurestandingposition,determinewhetherstancephaseresistanceisactivebyrepeatedlyflexingthekneejointslightlyundercontrolledload�

CAUTION

Safety mode cannot be deactivated. Whenthekneejointisinsafetymode,thismostlikelyindicatesakneejointdefect�Malfunctionsmayoccurinthisstate�Thiscancauseyoutofall�Ifthesafetymodecouldnotbedeactivatedbyrechargingthebattery,anerrorhasoccurred�Contacttheprosthetisttohavetheerrorcorrected�

Battery CapacityDuringnormaloperation,thebatterychargelevelisindicatedviavibrationsignals(inadditiontothedisplayontheremotecontrol)(seeSection“Chargingthekneejoint”)�


Storage and VentilationTostorethekneejoint,pushthekneeheadtotheflexionstop�Uponputtingthekneejointbackintouse,holditverticallywiththekneeheadupandpushthekneeheadtofullextension�Duringextendednon-verticalstorageofthekneejoint,airmayaccumulateinthehydraulics�Thisisnoticeablethroughsoundsandirregulardampingbehaviour�Theautomaticventilationmechanismensuresthatallfunctionsofthekneejointareonceagainavail-ableafterapprox�10 - 20steps�

Cleaning and CareIftheprosthesisislightlysoiled,cleanitwithadamp,softclothandmildsoap(e�g�Ottobock453H10=1DermaClean)�Afterwards,drytheprosthesiscomponentswithasoft,lint-freecloth�Incaseofextended,ongoingcontact,liquidshaveanegativeeffectonthefunctionalityoftheprosthesis�Thiscancauseleaksandthereforethefailureofelectroniccomponents�Ifliquidscomeintocontactwiththeprosthesis,theymustnotexceed65 °C�Aftercontactwithshampooorotherliquids(e�g�beverages),rinsetheprosthesisimmediatelyandthoroughlywithfreshwater�Subsequentlytilttheprosthesissothataccumulatedliquidcandrain�Allowtheprosthesistoairdryatroomtemperature�TheGeniumX3isresistanttoabrasivesurfaces(e�g�sand,grass,mud)�However,itmayonlybeusedintheseenvironmentstotheextentthatitcanbeeasilycleanedbyrinsingitwithfreshwater�Pleasenotethattheweightofdirtadheringtotheprosthesiscanaffectthegaitpattern�Incaseofheavysoilingthatcannotberemovedbyrinsing,pleasecontactyourprosthetist�

ServiceINFORMATION

ThiscomponenthasbeentestedaccordingtoISO10328standardforthreemillionloadcycles�Dependingontheamputee‘sactivitythiscorrespondstoadurationofuseofthreetofiveyears�Thedurationofusecanbeextendeddependingontheindividualintensityofusebymakinguseofregularserviceinspections(see3B5-X3/3B5-X3=STServicePass646D589=*)�

Intheinterestofyourownsafetyandinordertomaintainoperatingsafetyandwarranty,aserviceinspectionisrequiredafter12months�Thisserviceinspectionincludesaverificationofthesensorsandthereplacementofwornparts�Fortheserviceinspection,theGeniumX3kneejointwithinstalledAXONtubeadapter(2R19),remotecontrol(4X350-X3)andcompletecharger(4E60)includingpowersupply(757L16-*)and3B5-X3/3B5-X3=STServicePass(646D589=*)mustbesenttotheauthorisedOttobockServiceCentre�Pleasecontactyourprosthetistwellbeforetheserviceinspectionisdue�

WarrantyOttobockoffersanextensivewarrantyserviceonthebasisofthe3B5-X3/3B5-X3=STserviceandwarrantyconcept�Yourprosthetististhecontactperson�


Technical InformationOperating,storageandtransporttemperaturewithandwithoutpackaging: -10°Cto+60°C(14°Fto140°F)

Batterychargingtemperature: 0°Cto+45°C(32°Fto113°F)Relativehumidityrange: upto93%Operatingvoltageofthebatterycharger: 100Vto240VACOperatingfrequencyofthebatterycharger: 50Hzto60HzRemotecontrolchargingcycles(battery)(charginganddischargingcycles)afterwhichatleast80%oftheoriginalbatterycapacityremainsavailable:

300

Li-Ionbatterychargingcycles(joint)(charginganddischarg-ingcycles)afterwhichatleast80%oftheoriginalbatterycapacityremainsavailable:

500

Knee joints

Description 3B5-X3 3B5-X3=ST

Proximalconnection Pyramidadapter Threadedadapter

Distalconnection Tubeclamp

Weightwithouttubeadapter 1710g/3,77lbs

Prox�systemheighttoalignmentreferencepoint 0mm 26mm

MinimumdistalsystemheightWith2R19AXONtubeadapter

298mm

MaximumdistalsystemheightWith2R19AXONtubeadapter

514mm

Kneeflexionangle 135°

Framematerial Carbonfibre

Mobilitygrade 3,4

Bodyweightmax� 125kg(274lbs)

Waterproofnessofthekneejoint IPX7,protectedagainstwaterimmersionbutnotagainstjetsofwaterorsteam�


AXON Tube AdapterDescription 2R19Weight 190-300g/0�42-0�66lbsMaterial AluminiumBodyweightmax� 125kg(275lbs�)WaterproofnessoftheAXONtubeadapter

IPX7,protectedagainstwaterimmersionbutnotagainstjetsofwaterorsteam�

Use of SymbolsThemeaningofthesymbolsontheproductisexplainedbelow:

Thisproductmustnotbedisposedofwithregulardomesticwaste�Disposalthatisnotinaccordancewiththeregulationsofyourcountrymayhaveadetrimentalimpactonhealthandtheenvironment�Pleaseobservetheinformationprovidedbytheresponsibleauthoritiesinyourcountryregardingreturnandcollectionprocesses�

DeclarationofconformityaccordingtotheEuropeanDirectiveforMedicalDevices93/42/EECandRadioEquipment1999/5/EU

Legalmanufacturer

Inaccordancewiththerequirementsof“FCCPart15”(USA)

Non-ionisingradiation

Attention,hotsurface

Lotnumber

Serialnumberofthedevice�

Compliancewiththerequirementsaccordingtothe“RadiocommunicationsAct”(AUS)�


LiabilityTheproductmayonlybeusedunderthespecifiedconditionsandfortheintendedpurpose,andinconjunctionwiththemodularcomponentcombinationstestedfortheprosthesis,inaccordancewiththeOttobockMOBISmobilitysystem,andinaccordancewiththeinstructions�Themanufacturerisnotliablefordamagecausedbycomponentcombinationsthatwerenotauthorisedbythemanufacturer�

TrademarksAllproductnamesmentionedinthisaccompanyingdocumentaresubjectwithoutrestrictiontotherespectiveapplicabletrademarklawsandarethepropertyoftherespectiveowners�Allbrands,tradenamesorcompanynamesmayberegisteredtrademarksandarethepropertyoftherespectiveowners�Shouldtrademarksusedinthisaccompanyingdocumentfailtobeexplicitlyidentifiedassuch,thisdoesnotjustifytheconclusionthattherespectivedesignationisfreeofthird-partyrights�

CE ConformityTheGeniumX33B5-X3/3B5-X3=STkneejointmeetstherequirementsofthe93/42/EECguidelinesformedicaldevices�ThisdevicehasbeenclassifiedasaclassIdeviceaccordingtotheclassificationcriteriaoutlinedinappendixIXoftheguidelines�ThedeclarationofconformitywasthereforecreatedbyOttobockwithsoleresponsibilityaccordingtoAppendixVIIoftheguidelines�TheGeniumX33B5-X3/3B5-X3=STkneejointalsomeetstherequirementsofDirective1999/5/ECforradioequipmentandtelecommunicationsterminalequipment�TheconformityassessmentwascarriedoutbyOttobockaccordingtoAppendixIofthedirective�Acopyofthedeclarationofconformitycanberequestedfromthemanufacturer(seereverse)�

31

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©O

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646D

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02-1

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OttobockhasacertifiedQualityManagementSysteminaccordancewithISO13485�

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genium x3 - bionic prosthetic system

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