Spinal Modulation orporated MN0200 Implantable Neurostimulator User Manual LP0275 Rev B September 2011

Spinal Modulation, Incorporated Implantable Neurostimulator LP0275 Rev B September 2011

Revised user manual

Axium™NeurostimulatorSystemPhysicianImplantManualSpinalModulation,Inc.1135O’BrienDriveMenloPark,CA94025USACopyright©September2011bySpinalModulation,Inc.AllRightsReserved.Noportionofthismanualmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,recording,oranyinformationstorageandretrievalsystems,withouttheexpresswrittenpermissionofSpinalModulation,Inc.LP0275RevB,September2011TM
SpinalModulation,Inc. PhysicianImplantManualiContentsExplanationofSymbolsonProductorPackageLabeling................................................. 4 INTRODUCTION ............................................................................................................................ 5 SystemOverview ............................................................................................................ 6 IndicationsforUse .......................................................................................................... 7 Contraindications............................................................................................................ 7 SYSTEMDESCRIPTION.................................................................................................................... 7 TrialNeurostimulator(TNS) ............................................................................................ 9 ImplantableNeurostimulator(INS) ................................................................................. 9 ImplantLeads/TrialLeads/LeadExtension..................................................................10 ConnectorCableKit .......................................................................................................10 LeadAccessories ............................................................................................................10 ImplantationTools.........................................................................................................11 AdditionalAccessories ...................................................................................................11 ClinicalProgrammerandPatientProgrammer ...............................................................11 SterilizationInformation ................................................................................................12 StorageConditions.........................................................................................................12 ProductMaterials ..........................................................................................................12 SAFETYINFORMATION ..................................................................................................................13 • GeneralWarnings .................................................................................................13 • Warnings–ForUseinHomeorWorkEnvironments.............................................15 • Precautions ...........................................................................................................16 AdverseEvents ..............................................................................................................17 IMPLANTINGTHENEUROSTIMULATORSYSTEM ...................................................................................18 • PrecautionsfortheImplantProcedure .................................................................18 SelectionofNeurostimulatorTrialApproach .................................................................19 PreparingthePatientandDevicesforUse .....................................................................20 PlacingtheLead .............................................................................................................20 IntraoperativeTesting....................................................................................................25 RemovingtheDeliverySystemComponents–PercutaneousLeadTrial.........................26 LeadAnchoring–PercutaneousLeadTrial .....................................................................28 NeurostimulationTrial–PercutaneousLeadTrial...........................................................28 RemovingTrialLead–PercutaneousLeadTrial ..............................................................29 RemovingtheDeliverySystemComponents–ImplantLeadTrialOnly..........................29 LeadAnchoring ..............................................................................................................31
SpinalModulation,Inc. PhysicianImplantManualiiPercutaneousExtensionTunneling–ImplantLeadTrialOnly ........................................32 RemovingLeadExtension–ImplantLeadTrialOnly ......................................................33 CreatingtheINSPocket–Implant..................................................................................34 LeadorExtensionTunneling ..........................................................................................35 ConnectingLeadtoExtension ........................................................................................35 ConnectingtheINS.........................................................................................................36 ImplantingtheINS .........................................................................................................37 CheckingSystemIntegrity..............................................................................................38 CompletingtheProcedure .............................................................................................38 REPLACINGANINS ......................................................................................................................38 DisposingofanExplantedDevice...................................................................................39 APPENDIXA:TRIALLEADKIT/IMPLANTLEADKIT .............................................................................40 HowSupplied.................................................................................................................40 PackageContents...........................................................................................................40 DeviceSpecification .......................................................................................................41 APPENDIXB:TRIALNEUROSTIMULATOR ..........................................................................................42 DeviceDescription .........................................................................................................42 PackageContents...........................................................................................................42 DeviceSpecifications .....................................................................................................42 Handling ........................................................................................................................43 APPENDIXC:IMPLANTABLENEUROSTIMULATOR ................................................................................44 HowSupplied.................................................................................................................44 DeviceDescription .........................................................................................................44 PackageContents...........................................................................................................44 DeviceSpecifications .....................................................................................................44 Handling ........................................................................................................................45 DeviceLongevity............................................................................................................45 COMPANYANDAUTHORIZEDREPRESENTATIVECONTACTINFORMATION ..................................................46 
SpinalModulation,Inc. PhysicianImplantManual4ExplanationofSymbolsonProductorPackageLabeling ModelNumber LotNumber ConsultInstructionsforUse ReadtheManual Donotresterilize SingleUseOnly SterilizedbyEthyleneOxideGas UseByYYYY‐MMOpensterilepouchbypeelingpouchcornerOpensteriletraybypeelingtraycorner ManufacturerManufacturingDate WarningStandbyCautionNotwaterproofAppliestotheProgrammerwhenitisnotinitscarryingcase
SpinalModulation,Inc. PhysicianImplantManual5Limitedwaterproof.AppliestotheTNSAppliestotheProgrammerinitscarryingcase ContentsofPackageareNon‐SterileKeepDryStoragetemperatureStorebetween10%and90%humiditySterileComponentsStorebetween0%and93%humidityTNSandProgrammers Thedeviceisaradiotransmitter Magnet.ShowsthelocationoftheProgrammermagnet. AuthorizedEuropeanRepresentative RFOperatingFrequencies.NearbyequipmentemittingstrongmagneticfieldscaninterferewithRFcommunication,eveniftheotherequipmentcomplieswithCISPRemissionrequirements.Theoperatingcharacteristicsareasfollows:MICS/MedRadioband:402‐405MHz.TheeffectiveradiatedpowerisbelowthelimitsasspecifiedinEurope:ENETSI301839‐2USAFCC47CFRPart95;95.601‐95.673SubpartE,95.1201‐95.1219FCCID:Y8L‐MN0200Thisdevicemaynotinterferewithstationsoperatinginthe400.150–406.000MHzbandintheMeteorologicalAids,MeteorologicalSatellite,andEarthExplorationSatelliteServicesandmustacceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.IntroductionThismanualdescribestheAxium™NeurostimulatorSystem,includinginstructionsforimplantation.Fordetailedoperationandclinicalprogramminginstructions,refertotheClinicalProgrammerManual.
SpinalModulation,Inc. PhysicianImplantManual6SystemOverviewTheAxium™NeurostimulatorSystemconsistsofanImplantableNeurostimulator(INS)device,TrialNeurostimulator(TNS)device,aClinicalProgrammer,aPatientProgrammer,oneormoreleadswhichmaybeusedincombinationwithaleadextensionandtheaccessoriesandtoolsusedforimplantingthesystem.TheTNSorINSisconnectedtoleadsplacedwithintheepiduralspacenearthedorsalrootganglion(DRG).Uptofourleadsmaybeplacedandconnectedtotheneurostimulatortoprovidestimulation.PatientswhoareindicatedfortheAxium™ImplantableNeurostimulator(INS)SystemwillfirstundergoatemporarytrialperiodusinganexternalTrialNeurostimulator(TNS)Systemconnectedtoimplantedleads.Ifboththeclinicianandpatientbelievethatsufficientpainreliefwasachieved,thenthepatientwillbescheduledforanimplant,inwhichtheINSwillbeimplanted.NOTE:Inthismanualthegeneralabbreviation“NS”isusedforinformationwhichappliestobothTNSandINS.Inallothercasesthespecificabbreviations“TNS”or“INS”areused.
SpinalModulation,Inc. PhysicianImplantManual7IndicationsforUseTheAxium™NeurostimulatorSystemisindicatedasanaidinthemanagementofchronicintractablepainofthetrunkand/orlimbs.ContraindicationsPatientscontraindicatedfortheAxium™NeurostimulatorSystemarethosewho:• Haveanactiveimplantablemedicaldeviceincludingbutnotlimitedtocardiacpacemakersandcardiacdefibrillators• Areunabletooperatethesystem• Arepoorsurgicalrisks• Arepregnant• Areundertheageof18SystemDescriptionTheAxium™NeurostimulatorSystemconsistsofthefollowingcomponents:ComponentNameModelNumbersPackageContentInstructionsforUseTrialNeurostimulatorMN10100MN20100• TrialNeurostimulatorTrialNeurostimulatorManualImplantableNeurostimulatorMN10200MN20200• ImplantableNeurostimulator• LeadPortPlugs(3)• TorqueWrench• SterileMagnetSleeve• MedicalAlertCardPhysicianImplantManualTrialLeadKit(lengthincmspecifiedby‐XX)MN10350‐XXMN20350‐XX• TrialLead• 22cmSmallCurveDeliverySheath• 22cmBigCurveDeliverySheath• Guidewire• ComplexCurvedStylet• 4.5”14GDeliveryNeedle• SoftTissueAnchor(2)PhysicianImplantManual
SpinalModulation,Inc. PhysicianImplantManual8ComponentNameModelNumbersPackageContentInstructionsforUseImplantLeadKit(lengthincmspecifiedby‐XX)MN10450‐XXMN20450‐XX• ImplantLead• 22cmSmallCurveDeliverySheath• 22cmBigCurveDeliverySheath• Guidewire• ComplexCurvedStylet• 4.5”14GDeliveryNeedle• SoftTissueAnchor(2)PhysicianImplantManualConnectorCableKitMN11350MN21350• ConnectorCable• LeadIdentifiers(3)PhysicianImplantManualTunnelingToolKit30/51cmMN11900MN21900MN12200MN22200• Tunnelingtool30/51cm• Straw• TrocarTip• PencilTip• INSSizer• PortPlugs(3)• TorqueWrenchPhysicianImplantManualClinicalProgrammerMN10700MN20700• ClinicalProgrammer• ExternalMagnet• ProgrammerCharger• CarryingCaseClinicalProgrammerManualPatientProgrammerMN10600MN20600• PatientProgrammer• ExternalMagnet• ProgrammerCharger• CarryingCase• MedicalAlertCardPatientProgrammerManualAuxiliaryMagnetKitMN13300MN23300• AuxiliaryMagnetAncillaryItemsManualProgrammerChargerKitMN13400MN23400• ProgrammerChargerAncillaryItemsManualProgrammerCarryingCaseMN13500MN23500• ProgrammerCarryingCaseAncillaryItemsManualLeadAccessoriesKitMN12050MN22050• 4.5”14GDeliveryNeedle• 6.0”14GDeliveryNeedle• SoftTissueAnchor• ComplexCurvedStylet• 30cmBigCurveDeliverySheath• 30cmSmallCurveDeliverySheathPhysicianImplantManual
SpinalModulation,Inc. PhysicianImplantManual9ComponentNameModelNumbersPackageContentInstructionsforUse22cmSmallCurveDeliverySheathKitMN12150MN22150• 22cmSmallCurveDeliverySheaths(2)PhysicianImplantManual22cmBigCurveDeliverySheathKitMN13650MN23650• 22cmBigCurveDeliverySheaths(2)PhysicianImplantManual4.5”NeedleKitMN11700MN21700• 4.5”14GDeliveryNeedlePhysicianImplantManualLeadExtensionKit(lengthincmspecifiedby‐XX)MN10550‐XXMN20550‐XX• LeadExtension50cm• TorqueWrenchPhysicianImplantManualTrialNeurostimulator(TNS)TheexternalTNSdeviceconnectstotheTrialLead(s)orLeadExtensionsandiswornbythepatientforupto30daysduringthetrialperiod.TheTNSdevicehasabeltclipforthepatient’sconvenience.ImplantableNeurostimulator(INS)TheAxium™ImplantableNeurostimulator(INS)isanon‐rechargeable,4channelelectronicdevice.Itusesmicroelectroniccircuitry,poweredbyahermeticallysealedbattery,togenerateapulsedwaveformtostimulateneuraltissue.Theelectroniccircuitryandbatteryarehousedinahermeticallysealedtitaniumcase.EachneurostimulatorhasauniqueinternalidentifierthatallowsthephysiciantoidentifythetypeofdevicethroughanX‐ray.Theradiopaqueidentifierinsidethecaseallowsidentificationofboththedevicemanufacturerandmodelnumberusingstandardx‐rayequipment.FortheAxium™Neurostimulator,thecodeisSM001whichidentifiesSpinalModulationasthemanufacturerandMN10200/MN20200asthemodelnumber.
SpinalModulation,Inc. PhysicianImplantManual10TheINSispackagedinasealedinnertraywithinasealedoutertray.ImplantLeads/TrialLeads/LeadExtensionTheLeadKitscontaintheLeadsandtheindividualdeliverydevicesthatarerequiredfortheirplacement. CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.• Implant/TrialLeads:TheLeadsaredesignedforpercutaneousintroductionintothebodyusingaspecialneedleandasetofcustomdeliverytoolsprovidedintheirrespectivekits.EachLeadisfittedwithfourcylindricalelectrodesspacedatequalintervalswhichareintendedtoprovidestimulationatthetargetdorsalrootganglion(DRG).EachLeadispackagedwithaComplexCurvedStyletinsertedintotheLeadandtheLeadispre‐loadedintoa22cmSmallCurveDeliverySheathforthephysician’sconvenience.• LeadExtension:TheLeadExtensionconsistsofasiliconeportheaderthatacceptstheSpinalModulationTrialLeadandImplantLead.ItisintendedtoextendthelengthoftheleadandprovideaconnectionbetweentheleadandtheConnectorCableortheleadandtheImplantableNeurostimulatorSystem.TheLeadExtensionisintendedforchronicimplantationasacomponentoftheAxium™NeurostimulatorSystem.ConnectorCableKitTheConnectorCableconnectstheLeadsorLeadExtensiontotheexternalTNS.• ConnectorCable:TheConnectorCableispackagedseparatelyfromtheLeadandLeadExtensionKit.TheConnectorCableincludesaconnectorand2extensioncablesforuseasneeded.• LeadIdentifiers:TheLeadIdentifiersaresmallbentwiresthatcanbeinsertedintotheproximalstyletlumenintheleadsandareindividuallycoloredtoidentifytheleads.LeadAccessories• Small/BigCurveDeliverySheath:TheDeliverySheathsareintendedtoallowpassageoftheleadpercutaneouslyintotheepiduralspace.Thelabeledlengthofthesheathisthedistancefromthehubtothepre‐shapedtipandthelengthofthecurveatthetipisapproximately2mmfortheSmallCurveandapproximately8mmfortheBigCurve.• ComplexCurvedStylet:TheComplexCurvedStyletisintendedtoassistinsteeringandpositioningtheleadwithintheepiduralspace.TheComplexCurvedStylethasbeenpre‐insertedintotheLeadforthephysician’sconvenience.• 14GDeliveryNeedles:TheDeliveryNeedleisintendedtoaccesstheepiduralspace,providingaconduitforlead,guidewireanddeliverysheathplacement.• Guidewire:TheGuidewireisintendedtoverifythattheneedleisintheepiduralspaceafterusingalossofresistancetechnique.
SpinalModulation,Inc. PhysicianImplantManual11• SoftTissueAnchor:TheSoftTissueAnchorsareintendedtoanchortheLeadinthesofttissueorontheskinsurfaceproximaltothedistalcontactsoftheLead.ImplantationTools• TunnelingTool:ThetunnelingtoolisusedtoprovideaconduitfortheTrialLead,ImplantLead,orLeadExtensiontotheINSorawayfromthemidlineofthespine.Itispackagedwith2exchangeabletips:abluntpenciltipandasharptrocartip.Astrawisslidoverthetunnelingtoolandwhenthesteelhandleisremoved,thestrawprovidestheconduitfortunneling.• INSSizer:TheINSSizerisapproximatelythesamesizeastheINSandallowsthephysiciantoproperlysizetheINSpocket.• PortPlugs:TheportplugsareusedtofillunusedportsintheINS.TheyarepackagedwiththeINS,butspareportplugsarealsopackagedwiththeTunnelingToolKitsfortheconvenienceofthephysicianAdditionalAccessories• SterileMagnetSleeve:ThemagnetisplacedinthesterilesleevetoallowittobeusedduringtheimplantationoftheINS.• MedicalAlertCard:IdentifiesthepatientasauseroftheNeurostimulationSystem.• ProgrammerCharger:TobeusedwiththeClinicalorPatientProgrammerstochargethebatteryorallowuseoftheProgrammerswhilepluggedintostandardelectricaloutlets.• ProgrammerCarryingCase:ProtectstheProgrammersfromwater.• AuxiliaryMagnet:AllowstheusertotheturntheNSofforactivatesRFtoallowtheusertocommunicatewiththeNS.ClinicalProgrammerandPatientProgrammerTwoprogrammersareavailabletointeractwiththeNSdevice.1. TheClinicalProgrammerisusedtoprogramthestimulationparametersforboththeTNSandtheINS.TheinstructionsforprogrammingtheTNSandINSdevicesarethesame.TheClinicalProgrammerisusedbythephysicianorclinicalstaff.2. ThePatientProgrammerallowsthepatienttoadjustthestimulationsettingsoftheTNSandINSdeviceswithinlimitspresetbytheclinician.ThePatientProgrammeralsoallowsthepatienttoturnstimulationoff,ifnecessary.
SpinalModulation,Inc. PhysicianImplantManual12Note:FordetailedinformationandinstructionsrelatedtotheClinicalandPatientProgrammerandtheTrialNeurostimulator,refertotherespectiveusermanuals.SterilizationInformationSingle‐use,steriledevice‐ThesterilecomponentsoftheAxium™NeurostimulatorSystemareprovidedsterileinadoublepouchortrayassemblyandareintendedforsingleuseonly.Anexpirationdate(or“use‐before”date)ismarkedonthelabelofeachpackage.Usepropersteriletechniquestoopenthepackaging. WARNING:Donotresterilizeorreuseanydevicesforanyreasonbecauseofriskofinfectiontothesubjectandmalfunctionofthedevices.Sterilization–TheSpinalModulationINS,TrialLeadKit,ImplantLeadKit,LeadExtensionKit,LeadAccessoriesKitandTunnelingToolKitshavebeensterilizedusingethyleneoxide(EO)gas.StorageConditionsStoreallsterileproductincludingtheINS,Leads,andLeadAccessoriesKitsasfollows:StorageTemperature–Storecomponentsbetween14°F(‐10°C)and122°F(50°C).Temperaturesoutsidethisrangemaydamagethecomponents.Ifatemperaturedeviationhasoccurred,donotusetheproduct.StorageHumidity–Storecomponentsbetween10%and90%humidity.StorageEnvironment–Storecomponentsandtheirpackagingwheretheywillnotcomeincontactwithliquidsofanykind.ProductMaterialsPortionsoftheAxium™NeurostimulatorSystemwillcomeincontactwithbodilytissues. WARNING:Neurostimulationsystemshavematerialsthatcomeincontactwithtissue.Aphysicianshoulddeterminewhetherornotapatientmayhaveanallergicreactiontothesematerialsbeforethesystemisimplanted.Thefollowingmaterialsareimplantedandcomeincontactwithtissue:• Platinumiridium• StainlessSteel• Polyurethane• MP35N(nickel‐cobalt‐chromium‐molybdenumalloy)• Titanium • PEEK(polyetheretherketone)• Epotek• PFA(perfluoroalkoxycopolymerresin)• Siliconerubber• PMMA[poly(methylmethacrylate)]
SpinalModulation,Inc. PhysicianImplantManual13SafetyInformation GeneralWarningsThefollowingwarningsapplytotheuseoftheAxium™NeurostimulatorSystem:• ExternalDefibrillators–Safetyforuseofexternaldefibrillatordischargesonapatientreceivingneurostimulationhasnotbeenestablished.• MagneticResonanceImaging–Thepatientshouldbeadvisedtonotundergoanyelectivemagneticresonanceimaging(MRI)withthesysteminplace.UseofMRIinthevicinityofthelead(s)mayresultinforcefuldislodgmentofthelead(s),ordamagetotheNeurostimulator.Ifavoltageisinducedthroughthelead,itmaycauseuncomfortable(“jolting”or“shocking”)levelsofstimulationorinjurytothepatient.• UltrasonicScanning–Ultrasonicequipmentmaycausemechanicaldamagetotheleadifuseddirectlyoverthesite.• ElectrosurgeryDevices–Electrosurgerydevicesshouldnotbeusedincloseproximitytoimplantedlead(s).Contactbetweenanactiveleadandtheelectrosurgicalpencilcancausedirectstimulationofthecontactednerveandcancausesevereinjurytothepatient.Electrosurgerydevicesmayalsodamagetheleadandcausealossofstimulation.• PediatricUse–Useofneurostimulationhasnotbeenapprovedspecificallyforchildrenlessthan18yearsofage.• Pregnancy–Safetyandeffectivenessofneurostimulationforuseduringpregnancyandnursinghavenotbeenestablished.• Non‐EmergencyProcedures–Thepatientmustbeadvisedthattheymustnothavenon‐emergencyprocedureswhiletheyareundergoingtrialstimulation.• EmergencyProcedures–Thepatientshouldbeinstructedtodesignatearepresentative(familymemberorclosefriend)tonotifyanyemergencymedicalpersonneloftheirneurostimulatorimplant,ifemergencycareisrequired.EachpatientalsowillbeprovidedwithaMedicalAlertCardtocarrywiththemthatwillinformemergencymedicalpersonnelofthepatient’simplant.ThepatientshouldbeadvisedtousecautionwhenundergoinganyprocedurethatcouldincludeRFormicrowaveablation,defibrillationorcardioversion.• RoutineMedicalProcedures–Thepatientshouldbeinstructedtonottoundergodentalprocedures,diathermy,electrolysis,diagnosticultrasound,staticfieldtherapeuticmagnets,diagnosticX‐ray,andhighoutputultrasoniclithotripsy.TheseproceduresmayprovideinterferencethatcanaffectTNSorINSdeviceoperationoruseordamagecomponentsofthesystemthatmaycausepatientharm.
SpinalModulation,Inc. PhysicianImplantManual14IfthepatientwithanINSorTNSdeviceissubsequentlygivenanymedicaltreatmentinwhichanelectricalcurrentispassedthroughhis/herbodyfromanexternalsource,eitherthedeviceshouldfirstbedeactivated,orcareshouldbetakentomonitorthefunctioningoftheneurostimulatorduringtheinitialstagesoftreatment.• DiathermyTherapy–Donotuseshort‐wavediathermy,microwavediathermy,ortherapeuticultrasounddiathermy(allnowreferredtoasdiathermy)onpatientsimplantedwithaneurostimulationsystem.Energyfromdiathermycanbetransferredthroughtheimplantedsystemandcausetissuedamageatthelocationoftheimplantedelectrodes,resultinginsevereinjuryordeath.Diathermyisfurtherprohibitedbecauseitmayalsodamagetheneurostimulationsystemcomponents.Thisdamagecouldresultinlossoftherapy,requiringadditionalsurgeryforsystemimplantationandreplacement.Injuryordamagecanoccurduringdiathermytreatmentwhethertheneurostimulationsystemisturnedonoroff.Allpatientsareadvisedtoinformtheirhealthcareprofessionalsthattheyshouldnotbeexposedtodiathermytreatment.• CardiacPacemakersandImplantableCardiacDefibrillators(ICD)–Itispossiblethatthedevicemayaffecttheoperationofotherimplantabledevicessuchaspacemakersorimplantablecardiacdefibrillators.Thephysicianshouldbeawareofanyotherimplantabledevicesthepatientmayhaveorisscheduledtoreceive.• ExplosiveorFlammableGases–DonotusethepatientprogrammerorclinicalprogrammertocommunicatewiththeINSorTNSinanenvironmentwhereexplosiveorflammablegasfumesorvaporsarepresent.Theoperationoftheprogrammercouldcausethemtoignite,causingsevereburns,injury,ordeath.• CaseDamage–IftheINScaseispiercedorruptured,anexplosioncanoccurfromthebatterychemicals,whichcanleadtosevereburnsorevendeath.• DeviceComponents–TheuseofnonSpinalModulationcomponentswiththesystemmayresultindamagetothesystemandincreasedriskofharmtothepatient.• ComponentDisposal–ReturnallexplantedNeurostimulatorstoSpinalModulationforsafedisposal.Donotcrush,puncture,orburntheNeurostimulatorbecauseexplosionorfiremayresult.• ExposuretoFluids–ExposureoftheexternalTNSortheConnectorCabletowater,bodyfluids,saline,orcleaningagentscancausecorrosionandaffectstimulation.Ifthisoccurs,dryallcomponentsthoroughlypriortoleadconnection.DonotimmersetheexternalTNSorConnectorCableinfluids.• DeviceHandling‐ ThepatientmustbeinstructedtonotremovetheirTrialLead(s)orConnectorCable.Manipulationofthecomponentsmayresultinanundesiredoutcome,suchasthepatientdevelopinganinfection,gettingundesirablestimulation,oraccidentallyturningtheirstimulationoff.Thepatientmustbeinstructedtonotruborexertpressureontheimplantableneurostimulatorthroughtheskinasthismaycause:leaddislodgementleadingtostimulationattheimplantsite,deviceinversionleadingtotheinabilitytocommunicatewiththedevice,orskinerosionthatcanleadtoanothersurgicalprocedureorpossibleinfection.
SpinalModulation,Inc. PhysicianImplantManual15 Warnings–ForUseinHomeorWorkEnvironments• EquipmentOperation–Duringstimulation,patientsshouldbeadvisedtonotoperatepotentiallydangerousequipment,suchaspowertools,automobiles,orothermotorvehicles.Theyshouldnotclimbladdersorparticipateinotheractivitieswhereposturalchangeoranabruptmovementcouldaltertheperceptionofstimulationintensityandcausepatientstofallorlosecontrolofequipmentorvehiclesorinjureothers.• PatientActivity–PatientsshouldbeadvisedtolimittheiractivitiestolowormoderatelevelsduringtheirtrialstimulationperiodandthefirstsixweeksofimplantationoftheINS.Failuretodosomayresultinmigrationoftheleadscausinglossofstimulationtherapy,musclestimulationorpainfulstimulationtherebyrequiringreoperationtoreposition.• TheftDetectorsandMetalScreeningDevices–Certaintypesofantitheftdevices,suchasthoseusedatentrances/exitsofdepartmentstores,libraries,andotherpublicestablishments,and/orairportsecurityscreeningdevicesmayaffectstimulation.Itispossiblethatpatientswhoareimplantedwithnon‐adjacentmultipleleadsand/orpatientswhoaresensitivetolowstimulationthresholdsmayexperienceamomentaryincreaseintheirperceivedstimulation,whichhasbeendescribedbysomepatientsasuncomfortableorjolting.Itisrecommendedthatpatientsusecautionwhenapproachingsuchadeviceandthattheyrequestassistancetobypassthedevice.Iftheymustproceedthroughthedevice,patientsshouldturnofftheNSandproceedwithcaution,beingsuretomovethroughthedetectorquickly.• RestrictedAreas–Thepatientshouldbewarnedtoseekmedicalguidancebeforeenteringenvironmentswhichcouldadverselyaffecttheoperationoftheimplanteddevice,includingareasprotectedbyawarningnoticepreventingentrybypatientsfittedwithapacemaker.• ElectromagneticInterference(EMI)–Certaincommercialequipmentsuchasresistanceweldersandinductionfurnaces,certaincommunicationequipmentsuchasmicrowavetransmitters,linearpoweramplifiers,andhighvoltagepowerlinesmaygeneratesufficientEMItointerferewiththeINSandTNSSystemresultinginunderstimulation,overstimulation,ordifficultyindevicecommunications.CertainmedicaldevicesmayalsocauseEMIinterferenceandmakeitdifficulttocommunicatewiththeINSorTNS;suchdevicesincludebonegrowthstimulators,transcutaneouselectricalnervestimulation(TENS),andimplantedcardiacdevices.• LeadMovement–Thepatientshouldbeinstructedtoavoidexcessivebending,twisting,andstretching,enteringhyperbaricchambersabove2.0atmosphere,andoperatingtheneurostimulatorwhiledrivingorliftingobjectsofover2Kg(5lbs)foraminimumof6weeksafterimplantation.Theseactivitiesmaycauseleadmovement,whichcanresultinunderstimulationoroverstimulationforthepatient.Excessiveleadmigrationmayleadtotheneedforreoperationtoreplacetheleads.
SpinalModulation,Inc. PhysicianImplantManual16• TherapeuticRadiation–Therapeuticradiationmaydamagetheelectroniccircuitryofanimplantedneurostimulationsystem,althoughnotestinghasbeenperformedandnodefiniteinformationonradiationeffectsisavailable.Sourcesoftherapeuticradiationincludex‐rays,cobaltmachines,andlinearaccelerators.Ifradiationtherapyisrequired,theareaovertheimplantedINSshouldbeshieldedwithlead. PrecautionsThefollowingprecautionsapplytotheuseoftheAxium™NeurostimulatorSystem:• PhysicianTraining–Implantingphysiciansshouldbeexperiencedinthediagnosisandtreatmentofchronicpainsyndromesandhaveundergonesurgicalanddeviceimplantationtraining.• PatientSelection–Itisextremelyimportanttoselectpatientsappropriatelyforneurostimulationandthatthoroughpsychiatricscreeningbeperformed.Patientsshouldnotbedependentondrugsandshouldbeabletooperatethespinalcordstimulatorsystem.• Infection–Itisimportanttofollowproperinfectioncontrolprocedures.Infectionsrelatedtosystemimplantationmightrequirethatthedevicebeexplanted.• ImplantationofTwoSystems–Iftwosystemsareimplanted,ensurethatatleast15cm(6in)separatestheimplantedINSstominimizethepossibilityofinterferenceduringprogramming.• ImplantationofMultipleLeads–Ifmultipleleadsareimplanted,leadsandextensionsshouldberoutedincloseproximity.Nonadjacentleadscanpossiblycreateaconduitforstrayelectromagneticenergythatcouldcausethepatientunwantedstimulation.• HighStimulationOutputs–Stimulationathighoutputsmaycauseunpleasantsensationsormotordisturbancesormayrenderthepatientincapableofcontrollingthepatientprogrammer.Ifunpleasantsensationsoccur,thedeviceshouldbeturnedoffimmediately.• StimulationParameters–Patientsshouldbecautionedthatstimulationparametersmustbedeterminedunderthesupervisionofaphysicianandthattheyshouldnotadjuststimulationparameterswithinprescribedprogramsunlessorderedtodosobyaphysician.• CellularPhones–Theeffectofcellularphonesonneurostimulationsystemsisunknown;patientsshouldavoidplacingcellularphonesdirectlyoverthesystem.• TrialLeads–TrialLeadsareintendedforuseforupto30days.Useofthesedevicesmustbeperformedinaccordancewiththeinstructionsprovidedinthismanual.• Overprogramming–ExcessivecommunicationwiththedevicecanshortenthelifeoftheINS.Thepatientshouldbewarnedtocommunicatewiththedeviceonlywhennecessary.
SpinalModulation,Inc. PhysicianImplantManual17• TNSDeviceCare–Thepatientmustbeinstructedtonotspillfluidson,towashorotherwisegettheirTNSdevicewet.Thepatientmustnotshowerorbathewithit(spongebathsareacceptableaslongastheTNSdevicedoesnotgetwet).ThepatientmustbeinstructednottodropormishandletheirTNSdevice.Physicaldamagetotheunitmayimpairitsfunction.ThepatientmustbeinstructedtonotopentheTNScase.• LeadandCableCare–Thepatientmustbeinstructedtonotremovetheirlead(s)orConnectorCableduringthetrialperiod.Manipulationofthecomponentsmayresultinthepatientdevelopinganinfection,gettingundesirablestimulation,oraccidentallyturningtheirstimulationoff.• TNSDeviceFailure–Devicefailure,althoughunlikely,ispossibleduetorandomcomponentfailure.IftheTNSdevicestopsworking,thepatientshouldcontacttheirphysician.• TNSDeviceDisposal–ThepatientistobeinstructedthattheymustreturntheirTNSdeviceandPatientProgrammertotheirphysicianafterthetrialperiod.ThepatientmustbeinstructedtonotdiscardorburntheirTNSdevice.Firemaycausetheinternalbatterytoexplode.• TNSBatteryReplacement–ItisunlikelythatthebatterywillneedreplacementintheshorttimethatthepatienthastheirTNSdevice.However,iftheTNSdevicedoesnotfunctionthepatientmustnottrytoopentheTNScase.TheinternalbatterymustbereplacedbySpinalModulationpersonnelonly.Thepatientshouldbeadvisedtocontacttheirphysicianduringregularbusinesshours.• MaterialSensitivity–Hypersensitivity(rednessintheareaofskincontact)canhappenifthepatienthasanallergicreactiontothematerials.Ifthisoccurs,thepatientshouldbeinstructedtocontacttheirphysicianduringregulatorbusinesshours.AdverseEventsTheimplantationofaneurostimulationsysteminvolvesrisk.Inadditiontothoseriskscommonlyassociatedwithsurgery,thefollowingrisksarealsoassociatedwithimplantationanduseoftheAxium™NeurostimulatorSystem:• Pain(wheretheneedlehasbeeninserted)• Pain(causedbyunderstimulationduetoleadmigration)• Painovertheimplantableneurostimulatorsite• Escalatingpain• Bleeding(wheretheneedlehasbeeninserted)• Headache• Infection• Localizedcollectionofserous(clear)fluidatinjectionsite• Discomfortduringthetreatment• Allergicorrejectionresponsetoimplantmaterials• Constantpainattheleadsite• Stimulationofthechestwall• Leadmigration(movement)and/orlocalskinbreakage
SpinalModulation,Inc. PhysicianImplantManual18• Weakness• Clumsiness• Numbness• TemporarymuscleactivationVeryrarerisksandsideeffectsinclude:• CerebralSpinalFluid(CSF)leakage• Tissuedamage• Nervedamage• Spinalcordcompression• Paralysis• Hematoma• Swelling• Seroma• Sensoryloss• SkinerosionaroundtheINSorleads• Batteryfailureand/orbatteryleakage• Leadbreakagerequiringreplacementofthelead• Hardwaremalfunctionrequiringreplacementoftheneurostimulator• Painfromanon‐injuriousstimulustotheskin(allodynia)• Anexaggeratedsenseofpain(hyperesthesia)Additionalriskstothesubjects,asaresultoftheplacementandstimulationoftheleadintheareaoftheDRG,includepotentialtissuedamageorpainduetosettingthestimulationparameterstoohigh.Thismayoccuroncetheleadisinplaceandisconnectedtotheneurostimulatorandactivated.Theneurostimulatoriscontrolledbyatrainedoperatorandthestartingpointforthestimulationwillbesettothelowestavailablesettings.Additionally,allsubjectswillbeawakeandconversantduringtheproceduretominimizethelikelihoodofanynervedamage.ImplantingtheNeurostimulatorSystem PrecautionsfortheImplantProcedure• Allimplantingphysiciansshouldbeexperiencedinthediagnosisandtreatmentofchronicpainsyndromesandhaveundergonesurgicalanddeviceimplantationtraining.• Donotbend,kink,orstretchtheleadbody,sheaths,orothercomponentsasthismayresultindamagetothecomponentandpoorfunction.• Donotinsertthesheathintotheepiduralspacewithouttheleadinserted,asthismaycauseinjurytothedura.Theleadcannotbeinsertedintothesheathwiththesheathintheepiduralspace.
SpinalModulation,Inc. PhysicianImplantManual19• Wheninsertingthelead/sheathassemblythroughtheneedleintotheepiduralspace,tightentheleadstabilizertopreventleadmigrationoutofthesheath.Failuretodosomaycauseharmtothepatientsuchasdamagetothedura.• Donotbendthesheathwithouttheleadinsidethesheath,asthiswillpermanentlykinkitandmakeitdifficulttodeploythelead.• Donotusesurgicalinstrumentstohandlethelead.Theforceoftheinstrumentsmaydamagetheleadorleadstylet.• Donotbend,kinkorusesurgicalinstrumentsonthestylet,asthismaydamageit.Usecarewhenreinsertingastylet.Toomuchpressureonthestyletcoulddamagethelead,resultinginintermittentorlossofstimulation.• Donotovermanipulatethesheathandleadsystemasthismayresultintraumawithintheepiduralspace.• Donotusesalineorotherionicfluidsatornearanyoftheelectricalconnections,asthiscouldresultinshortcircuits.• Donotplacesuturesdirectlyaroundtheleadbodysincethesuturesmaydamagethelead.• Beforeopeninganysterilepackage,verifythekitmodelnumber,thatthekitiswithinitsexpiration(use‐by)dateandthatthepackaginghasnotbeendamagedorcompromisedinanyway.Ifthepackaginghasbeencompromisedorthedeviceisbeyonditsexpirationdate,donotusethedeviceasitmaybecompromisedandcouldcauseharmtothepatient.• Carefullyinspectthelead(inthesterilefield)fordamageafterremovingitfromthesterilepackage.Damagetotheleadbodycancauseimproperfunctionandstimulationorstimulationtoareasotherthantheintendedtarget.• Iftheoperatingfieldisbloody,wipegloves,lead,stylet,andsheath,beforehandlingthelead.Failuretodosomayresultindifficultydeliveringthelead.• Theleads,accessories,andneurostimulatorareonlycompatiblewiththeSpinalModulationcomponents.Useofothermanufacturer’scomponentsmayresultinunexpecteddeviceperformanceandincreasedriskofinjurytothepatient.SelectionofNeurostimulatorTrialApproachTherearetwosuggestedapproachesforaneurostimulationtrial:A. PercutaneousLeadTrial‐AtrialisdoneusingaTrialLeadwhichexitstheskinattheneedleentrysiteandwhichiscompletelyremovedafterthetrialperiod.Inasecondprocedure,thesystemisimplanted,includingtheImplantLeads.
SpinalModulation,Inc. PhysicianImplantManual20B. ImplantedLead+PercutaneousExtensionTrial–AtrialisdonewithanImplantLeadsuturedtothesofttissuejustabovethespinousprocess,usingthesofttissueanchortoprotectthelead.Anextensionistunneledawayfromtheneedleinsertionsitewhereitexitstheskin.InasecondprocedureonlytheLeadExtensionisremovedandtheLeadoranewLeadExtensionistunneledtoapocket,theINSisimplantedinthepocket,andtheLeadorLeadExtensionisconnectedtotheINS.PreparingthePatientandDevicesforUseLeadsaredesignedforplacementintheepiduralspace.EachLeadisaccompaniedbyaccessoriesdesignedtoaidtheclinicianinpositioningthetipoftheLeadnearthetargetDRG.• ToperformaPercutaneousLeadtrial,usethetemporaryTrialLeadKit.• ToperformanImplantLeadtrial,usetheImplantLeadKit. CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.Useofthesedevicesmustbeperformedinaccordancewiththeinstructionsprovidedinthismanual.Usingstandardsteriletechnique,performtheappropriateskinprepping,draping,andinjectionoflocalanesthetictoperformtheepiduralapproachesforpercutaneousleadplacement. WARNING:Theplacementoftheleadsinvolvessomerisk,aswithanysurgicalprocedure.Conscioussedationcancausesideeffectssuchassystemictoxicity,orcardiovascularorpulmonaryproblems.Usecautionwhensedatingthepatient.Thepatientmustbeawakeandconversantduringportionsoftheproceduretominimizethelikelihoodofnervedamage.PlacingtheLeadLeadplacementshouldalwaysbedoneunderfluoroscopicguidance.Theappropriatevertebrallevelforneedleentryshouldbeidentifiedandmarked. WARNING:Aswithanyspinalepiduralprocedure,potentialrisksofseriousinjurytothepatient,althoughextremelyrare,includeepiduralhemorrhage,hematoma,infection,spinalcordornervecompression,and/orparalysis.1. DeterminethelengthoftheleadrequiredtoextendfromthetargetforaminalleveltotheNeurostimulatorimplantationsite.Usinga90cmleadinthelumbarregionmaycausedifficultyincoilingtheexcesslead.A50cmleadusedintheupperthoracicregionmaynotbelongenoughtoreachtheNeurostimulatorandaleadextensionmaybeneededtobridgetheadditionallength.
SpinalModulation,Inc. PhysicianImplantManual21ChoosinganApproach2. AntegradeApproachUnderfluoroscopicguidance,useacontralateralapproach,withthebeveloftheneedlefacingtowardthetargetlevel,toinserttheDeliveryNeedleintotheepiduralspaceattheappropriateangleuntilyouencounterresistancefromtheligamentumflavum.Startoneortwolevelsbelowthetargetsite.Theneedleangleshouldbenogreaterthan30degreestoensuresmoothdeliveryofthedeliverysheathandlead.  SingleLevelDeliveryApproachTwoLevelDeliveryApproach 3. ContralateralApproachUnderfluoroscopicguidance,useacontralateralapproachwiththebeveloftheneedlefacingtowardthetargetleveltoinsertthe14Gdeliveryneedleintotheepiduralspace. WARNING:Whenusingacontralateralapproach,advancetheneedleslowlyintotheepiduralspaceandtakecautionasitenters.Theneedlewillbeinsertedatasteeper
SpinalModulation,Inc. PhysicianImplantManual22anglethaninanantegradeapproachandthereisagreaterchanceofduralpuncturethatwillleadtoacerebrospinalfluidleak.4.Confirmentryintotheepiduralspaceusingstandardmethods,suchasalossofresistancetechnique.5. Oncelossofresistanceisachieved,theclinicianmayverifycompleteinsertionintotheepiduralspaceusingfluoroscopicguidanceand/orinsertingtheguidewirethroughtheneedle.Ifresistanceisdiscoveredduringguidewireinsertion,eitherpulltheneedleoutandrepeatSteps1‐4usingamoreacuteangleoradvancetheneedlefurtherandreconfirmplacementusingtheguidewire. WARNING:Usefluoroscopyandextremecarewheninserting,advancing,ormanipulatingtheguidewireorleadintheepiduralspacetominimizetheriskofaduraltear. WARNING:Duralpuncturecanoccurifneedleorguidewireisadvancedaggressivelyoncelossofresistanceisachieved.Advancetheneedleand/orguidewireslowly.6. Removetheguidewire(ifused)afterconfirmationofaccesstotheepiduralspace.NOTE:TheComplexCurvedStylethasbeenpre‐insertedintotheleadandtheleadhasbeenloadedintoa22cmSmallCurveSheathtofacilitatedeliverybytheclinician.7. Beforeinsertionintotheneedle,pushtheleadoutsidethesheathandverifythatthestyletispushedfullydistalwithinthelead.NOTE:Failuretoensurethestyletiscompletelyinsertedmaymakedeliveryoftheleadmoredifficult.8. Beforeinsertionintotheneedle,pullbackontheleadsothattheball‐tipendoftheleadisflushagainsttheDeliverySheathandtightendowntheleadstabilizeruntiltheleaddoesnotslidewithinthesheath.
SpinalModulation,Inc. PhysicianImplantManual23TighteningtheLeadStabilizer WARNING:Insertionofasheathwithouttheleadmayresultinduralpuncture.Securingtheleadwiththeleadstabilizerwillmitigatethisrisk. WARNING:UseofthedeliverysheathisnecessaryforsuccessfulplacementoftheLead.9. Notethatthesteeringwingonthesheathlinesupwiththebendinthesheath.10. Beforeinsertingthesheathintotheneedle,verifythattheLeadisloaded.TheLeadcannotbedeliveredthroughthesheathoncethesheathislocatedwithintheepiduralspace.11. Insertthesheath,lead,andstyletthroughtheneedleandadvancethroughtheepiduralspacetothetargetforaminalopening. WARNING:Ifthesheathneedstoberetractedfromtheepiduralspace,verifythatthesteeringwingisnomorethan90degreesmisalignedwiththemarkontheneedle.Failure
SpinalModulation,Inc. PhysicianImplantManual24todosomayresultindamagetothesheath.Beforereinsertingsheath,verifythereisnodamagetothesheath. WARNING:Ifthesheathisnotrespondingtorotation,donotrotatethesteeringwingoutofplanefromthecurveofthesheathmorethan90degrees.Thetipofthesheathmaywhiparoundandcouldcauseharmtothepatient.12. Withthedistalendofthesheathinoratthetargetforamen,loosentheleadstabilizer,andadvancetheleadsothatitmovesintotheforamen.Confirmplacementoftheleadonthedorsalsideoftheforamenusingalateralfluoroscopicview.Verifythattheelectrodesextendoutofthesheath.Iftheelectrodesremainwithinthesheath,stimulationwillnotbepossiblebecauseofhighimpedancereadings.LooseningtheLeadStabilizer WARNING:Iftheleadisunabletodeployoutofthesheath,injectsterilewaterorsalineslowlytoreleasetissuethatmayhaveenteredbetweenthesheathandthelead.Donotuseexcessivepressurewheninjectingthroughthesheath.
SpinalModulation,Inc. PhysicianImplantManual25LeadAdvancedAlongDorsalAspectofDRG WARNING:Donotuseexcessiveforcetopushtheleadorsheathintotheneuralforamenasthismayresultinpermanentortransientnervedamage.Thepatientshouldbeawakeandconversantduringthispartoftheproceduresotheycanprovidefeedbacktothephysician.IntraoperativeTesting1. Connecttheheadtothecable.Pressandholdthecablebuttondowntoreleasethelockingmechanismandslidetheproximalendoftheleadsintothehead.Releasethecablebuttontolocktheleadintoplace.Verifythattheleadcomestoastopbeforereleasingthebutton.Thiswillensurethattheelectricalcontactsareintheappropriateposition.2. PuttheTNSinstandbymodeorturntheamplitudeofeachleadsettozero. PRECAUTION:Putthetrialstimulatorinstandbymodeorreduceamplitudeofleadstozerobeforeplugginginthecable.Failuretodosomayresultindeliveringanuncomfortablestimulationtothepatient.3. PasstheproximalendoftheConnectorCableoffthesterilefieldandconnecttotheTNS.Head
SpinalModulation,Inc. PhysicianImplantManual26NOTE:RefertotheTrialNeurostimulatorUserManualandClinicalProgrammerUserManualforspecificinstructionsontheoperationofthesedevices. WARNING:Maintainadequateslackinthecable.Ifthereisnotenoughslackandthecableispulled,theleadmaybedislodgedandwillneedtobereplaced.Thiswillextendtheprocedure.4. UsingtheTNS,testthevariouselectrodeconfigurationsusedtoobtainappropriateparesthesiaorpainrelief.5. TurnofftheTrialNeurostimulatoranddisconnecttheleadfromtheconnectorcable.6. Uptofourleadsmaybeplacedinonepatient.Referto“PlacingtheLead”topositionsubsequentleads. WARNING:AsdescribedintheClinicalProgrammerUserManual,alwaysturntheexternalTNSamplitudeto0µAwhenrepositioningalead,changingtheselectedelectrodecombination,orattachingtheConnectorCabletotheexternalTNS.Whenrestartingstimulation,increasetheamplitudeSLOWLYuntilthedesiredparesthesiaisachieved.Failuretodosomayresultinuncomfortablemotoractivationorpainfulstimulation.RemovingtheDeliverySystemComponents–PercutaneousLeadTrial1. Beforeremovingthedeliverysystemcomponents,advancetheleadfurtherintotheepiduralspacetocreateastrainrelief.2. Slowlyremovethedeliverysheathbyfirstpullingbackthesheathneartheneedle.AlwaysholdforwardpressureontheLeadwhileretractingthedeliverysheathtopreventleadmigration.3. Retractthestyletintotheneedlesothatitisretractedbeyondthetipofthesheath.4. Turnthesheathawayfromtheopeningoftheforamenandpushouttheleadsothataloopiscreatedintheepiduralspace.
SpinalModulation,Inc. PhysicianImplantManual27 WARNING:Failuretoputaloopintheepiduralspacemayresultinleadmigrationandmayleadtoaproceduretorevisetheposition.5. Removethesheathcompletelywhileholdingforwardpressureonthelead. WARNING:Whenremovingthesheath,verifythatthesteeringwingisnomorethan90degreesmisalignedwiththemarkontheneedle.Failuretodosomayresultindamagetothesheath.Beforereinsertingsheath,verifythereisnodamagetothebendofthesheath.6. Removetheneedlefollowingthesameprocedure.Itisrecommendedthatthedesiredparesthesiabere‐testedaftertheremovalofthedeliverysystemcomponentsbutbeforethecompleteremovalofthestylet.WiththeexternalTNSamplitudesetto0µA,reconnecttheConnectorCableasdescribedbefore. WARNING:Ifthesheathhasbeenkinkedduringdelivery,slowlyretractthroughtheneedlewiththecurvefacingthesamedirectionasthebevel.Failuretodosocandamageorcuttheleadorsheath.Ifresistanceisencountered,pulltheneedleoutoftheepiduralspaceandthenremovethesheath. WARNING:Donotuseexcessiveforceiftheleadneedstoberemoved.Excessiveforcemaycauseleadfracture.7. RecordtheleadpositionwithbothanA/Pandlateralfluoroscopicviewforcomparisonofthepositionattimeofclosuretoensurethattheleadhasnotmoved.Removethestyletbyholdingforwardpressureontheleadwhileretractingthestylet. WARNING:Useextremecarewhenremovingtheleadstylet,thedeliverysheath,andtheneedle,toinsurethatthedistaltipoftheleadremainsinthedesiredlocation.Removingeachiteminslowmovements,whileholdingtheremainingcomponentsin
SpinalModulation,Inc. PhysicianImplantManual28place,willassistthisprocess.LeadAnchoring–PercutaneousLeadTrial1. AfterplacingaTrialleadinitsfinalposition,itshouldbesecuredusingaleadanchorontheskin.2. CarefullyslidetheleadanchorovertheproximalendoftheTrialLeadandadvanceittothepuncturesite.Theshortendofthesutureanchormustbefacingtowardstheincision.3. ApplysuturesaroundtheanchorandcinchontotheTrialLeadasshownbelow.Applyatleasttwotiestothemainbodyandonetietotheleg. WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.Failuretosecuretheleadtotheskin,orothertissue,mayresultinleadmigrationand/ormotoractivationorpainfulstimulation. WARNING:Failuretocomplytotheanchoringtechniquemayresultinleadmigrationand/ormotoractivationorpainfulstimulation.4. Applyanantibacterialagenttothepuncturesite,ifdesired5. ReconnecttheconnectorcabletotheleadsandcoilanyexcessTrialLeadlengtharoundthedistalendoftheConnectorCable,foldagauzepadaroundtheblock,andapplyalargeadhesivepatchovertheareacontainingtheTrialLead(s),puncturesiteandConnectorCable.6. VerifytheconnectionoftheConnectorCabletotheTrialLeadsandtheexternalTNSpriortodischargeofthepatient.NeurostimulationTrial–PercutaneousLeadTrial1. UsingtheClinicalProgrammer,programtheTNSwiththeneurostimulationtrial
SpinalModulation,Inc. PhysicianImplantManual29parameters.NOTE:RefertotheTrialNeurostimulatorUserManualandClinicalProgrammerUserManualforspecificinstructionsontheprogrammingofthesedevices.RemovingTrialLead–PercutaneousLeadTrial WARNING:AlwaysremovetheTrialLeadsbeforeimplantingtheImplantLeads,asthereisariskofinfectionthatmaycausedeathiftheleadsarenotremoved.Alwayspracticepropersterilepracticeswhenimplantingleadsandimplantableneurostimulator.ToremovetheTrialLead(s)fromapatient:1. DisconnecttheConnectorCableconnectionforeachTrialLead.2. RemoveanysuturesoranchorsecuringeachTrialLeadtothepatient’sskin.3. SlowlyapplylighttensiontoeachTrialLeadandverifythattheleadisretractingfromthepatient.4. PlacetheusedTrialLead(s)intoadesignated“Biohazard”packageclearlylabeledwiththepatient’sIDnumberandtheremovaldate.5. SendTrialLead(s)backtoSpinalModulationforevaluationasinstructedbyclinicalpersonnel. WARNING:DonotremoveaTrialLeadquickly,asthismayresultinleadbreakageandunintentionalleadfragmentsbeingleftinthepatient. WARNING:TakeproperprecautionswhenhandlingremovedTrialLeadcomponents.TreatallusedTrialLeadsanddeliverycomponentsasa“biohazard”. WARNING:DonotreuseanydevicefromtheTrialLeadKitorTrialAccessoriesKit.RemovingtheDeliverySystemComponents–ImplantLeadTrialOnlyTheseinstructionspertainonlyafterplacingImplantLeadduringthetrialprocedure.Afterplacingaleadinitsfinalposition,usingthetechniquesdescribedabove,itshouldbesecuredusingaleadanchortothesupraspinousligamentorfasciaandthenconnectedtotheexternalizedleadextensions. WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.Failuretosecuretheleadmayresultinleadmigrationanduncomfortablemotorstimulationorpainfulstimulation. PRECAUTION:Useextremecarewhenusingsharpinstrumentsorelectrocauteryaroundtheleadtoavoiddamagingthelead.1. Leavingtheneedleinplace,preparetheanchorsitebymakinganapproximatelya3‐7cm
SpinalModulation,Inc. PhysicianImplantManual30longitudinalincision,centeredontheneedletothedepthofthesupraspinousligament.2. Establishhemostasisanduseretractorsforgoodvisualization.3. Slowlyremovethedeliverysheathbyfirstpullingbackthesheathneartheneedle.AlwaysholdforwardpressureontheLeadwhileretractingthedeliverysheathtopreventmovement.4. Retractthestyletintotheneedlesothatitisretractedbeyondthetipofthesheath.5. Turnthesheathawayfromtheopeningoftheforamenandpushouttheleadsothataloopiscreatedintheepiduralspace. WARNING:Failuretoputaloopintheepiduralspacemayresultinleadmigrationandmayleadtoaproceduretorevisetheposition.6. Removethesheathcompletelywhileholdingforwardpressureonthelead. WARNING:Whenremovingthesheath,verifythatthesteeringwingisnomorethan90degreesmisalignedwiththemarkontheneedle.Failuretodosomayresultindamagetothesheath. WARNING:Ifthesheathhasbeenkinkedduringdelivery,slowlyretractthroughtheneedlewiththecurvefacingthesamedirectionasthebevel.Ifresistanceisencountered,pullouttheneedleandthenproceedtoremovethesheath.Failuretodosocandamageorcuttheleadorsheath.
SpinalModulation,Inc. PhysicianImplantManual317. Removetheneedlefollowingthesameprocedure.8. Itisrecommendedthatthedesiredparesthesiabere‐testedaftertheremovalofthedeliverysystemcomponentsbutbeforethecompleteremovalofthestylet.WiththeexternalTNSamplitudesetto0µA,reconnecttheConnectorCableasdescribedbefore. WARNING:Donotuseexcessiveforceiftheleadneedstoberemoved.Excessiveforcemaycauseleadfracture.9. RecordtheleadpositionwithbothanA/Pandlateralfluoroscopicviewforcomparisonofthepositionattimeofclosuretoensurethattheleadhasnotmoved.Removethestyletbyholdingforwardpressureontheleadwhileretractingthestylet. WARNING:Useextremecarewhenremovingtheleadstylet,thedeliverysheath,andtheneedle,toensurethatthedistaltipoftheleadremainsinthedesiredlocation.Removingeachiteminslowmovements,whileholdingtheremainingcomponentsinplace,willassistthisprocess.LeadAnchoringAfterplacingaleadinitsfinalposition,itshouldbesecuredusingasofttissueanchorandthenconnectedtoexternalizedextensions. WARNING:Donotsuturedirectlyontothelead,asthereisariskofdamagingthelead.Failuretosecuretheleadtotheskin,orothertissue,mayresultinleadmigrationanduncomfortablemusclestimulation. PRECAUTION:Useextremecarewhenusingsharpinstrumentsorelectrocauteryaroundtheleadtoavoiddamagingthelead.1. Soaktheanchorinsterilewater(notsaline)tolubricateit.2. Placetheanchorontheleadandslideitdownascloseaspossibletowheretheleademergesfromthevertebralcolumn.Becarefulnottomovethelead.NOTE:Ifimplantingmultipleleads,tagtheleadswithsuture(ligature)sothattheirpositioncanbeidentifiedlater. PRECAUTION:Observethesecautionswhenattachingthesofttissueanchorbecausedamagetotheanchororleadcanoccurandresultinfailureofthesystem:• Donotusepolypropyleneormonofilamentsuture• Donotplacesuturesdirectlyonthelead.• Avoidsharpbendsorkinkingonthelead.
SpinalModulation,Inc. PhysicianImplantManual323. Usingthe2‐0silknon‐absorbablesuture,tietwoligaturesaroundthecenteroftheanchortosecuretheanchortothelead.Ifneeded,makeminoradjustmentstotheleadposition.Tieoneligaturearoundtheleganddonottietothesofttissue.Verifythattheshortendoftheanchorentersintotheligament. PRECAUTION:Failuretopushtheshortendofthesofttissueanchorintotheligamentorfasciamayresultinleadmigrationandaproceduretorevisetheleadlocation.4. Itisrecommendedthattheleadpositionisverifiedunderfluoroscopyanddesiredparesthesiabere‐testedafterfixation.WiththeexternalTNSamplitudesetto0µA,reconnecttheConnectorCableasdescribedbefore.PercutaneousExtensionTunneling–ImplantLeadTrialOnly1. Identifythetunnelingroutebetweentheleadincisionandtheextensionexitsite.2. Administeranestheticattheexitsiteandalongthetunnelingroute.3. Assemblethetunnelingtoolpackagedwiththeleadbyslippingthepassingstrawoverthetunnelingrod,thenattachingthetunnelingtip.4. Bendthetunnelingtoolasnecessarytoconformtothepatient’scontouralongthetunnelingroute.5. Makeastabwoundattheexitsite.6. Beginattheexitsiteandtunnelsubcutaneouslytotheleadincision7. Guidethetunnelingtoolsubcutaneouslyalongthetunnelingroutebypushingtheskinovertheadvancingtooltipuntilthetipandapproximately1cmofthepassingstrawareexposedattheleadincision.8. Withdrawthetunnelingtoolleavingthepassingstrawinplaceinthetunnel.9. Gentlyinserttheproximalendoftheextensionthroughthepassingstrawtotheexitsite.
SpinalModulation,Inc. PhysicianImplantManual3310. Slidethepassingstrawovertheextensionandoutoftheskinexitsite,leavingtheextensioninplace.11. Ifnotdonepreviously,usebluntdissectiontoaformasubcutaneouspocketofftheleadincisionforthelead‐extensionconnection.12. Wipetheleadandextensionconnectorjunctionwithsterilegauze.Ifnecessary,moistenthegauzewithsterilewateroranonionicantibioticsolution.13. Dryallconnections.Fluidintheconnectionmayresultinstimulationattheconnectionsite,intermittentstimulation,orlossofstimulation.14. Holdtheextensionconnectorstraightwhilefirmly,butgently,insertingtheleadintotheconnectoroneortwocontactsatatimeuntileachleadcontactisalignedundereachextensionconnectorcontact.Duringinsertion,someresistanceistypicalbecausetheinternalsealsprovideelectricalisolation.15. Verifythatthemarkontheleadalignswiththeendoftheextensionconnector.Thiswillverifythattheleadisfullyinserted.16. Usethetorquewrenchsuppliedinthepackagetotightenthesetscrew.Tightenuntilaclickisheard.Usingminimalforce,andwhilesecurelyholdingtheleadtopreventdislodgement,pullontheconnectiontoensurethatitissecure.17. Usingminimalforce,pulltheextensionfromtheskinexitsite,feedingthelead‐extensionconnectionintothelead‐extensionconnectionpocket.18. Inordertoaidinidentificationofeachleadafterthetrialperiod,tieasuturelightlytotheleadandanotheronetotheleadextension.Usedifferentcolorsutureandnumbersofsuturetoidentifytheleads.Thiswillaidinidentificationduringtheimplantprocedure.19. Createstrainreliefloopsbycoilingexcessleadproximaltothesofttissueanchorinloops.Insertthecoiledleadintothepocket,undertheconnection,leavingasmuchslackaspossibleintheleadbetweentheanchorandthelead‐extensionconnection.20. Closetheincisionanddresstheincisionsite.21. Attheexitsite,coilanyexcessextensionaroundthedistalendoftheConnectorCable,foldagauzepadaroundtheblock,andapplyalargeadhesivepatchovertheareacontainingexitpuncture,excessextension,andConnectorCable.RemovingLeadExtension–ImplantLeadTrialOnly1. Removethebandageneartheexitpointoftheleadextension.2. Pulltheleadextensionlightlyoutoftheincisionandcuttheleadextension.3. Exposethelead‐extensiontoleadconnection.4. Whilemaintainingleadposition,carefullyremovethelead‐extensionconnectionsfromtheincision.5. Disconnecttheleadfromtheextension.
SpinalModulation,Inc. PhysicianImplantManual346. Cuttheextensionnearthelead‐extensionconnector.7. Discardthelead‐extensionconnector.8. Preservingsterility,pulltheextensionoutthroughtheskinexitsite.9. Discardtheextension.10. Ifmultipleextensionsareimplanted,repeattheremovalstepsfortheotherextensions.CreatingtheINSPocket–ImplantOncethelead(s)hasbeenanchored,aNeurostimulatorpocketshouldbecreatedandtheleadtunneledforconnectiontotheINS.ThefollowingstepsoutlinethesuggestedproceduretocreateanINSpocket:1. DeterminethesitefortheINS.ThisshouldbedonebeforeimplantingtheleadtoverifythereisenoughlengthtoreachtheINSpocketandprovidestrainreliefinthepocket,neartheanchor,andintheepiduralspace.NOTE:TheINSshouldbelocatedinanareathatthepatientcaneasilyreachwiththemagnetand/orprogrammer:• Intheupperbuttocksalongtheposterioraxillaryline(avoidingthebeltline)• Justovertheabdomenbelowthelowestrib2. Administerlocalanestheticattheneurostimulatorpocketsite.3. UsebluntdissectiontocreateapocketsothattheINSisparalleltotheskinsurfaceandnodeeperthan2.0cmbelowtheskinsurface.Useelectrocauterytomaintainhemostasis.4. (Optional)InserttheINSsizertoensurethepocketislargeenoughtoaccommodatetheINS,allowingextraroomforastrainreliefloopforeachlead. PRECAUTION:DonotimplanttheINSdeeperthan2.0cm,astheprogrammerwillnotbeabletocommunicatewiththeINS.
SpinalModulation,Inc. PhysicianImplantManual35 PRECAUTION:DonotapplyelectrocauterydirectlytotheINSasthiscandamagetheINSorcauseinterferencewhilecommunicatingwiththeINS.LeadorExtensionTunnelingTunneltheleadsfromtheanchorsitetotheINSpocket.Whentunnelingtotheabdomen,theclinicianhastwooptions:• TunneltoamidpointandthencontinuetoINSsite.• Usethe51cmtunnelingtoolandcurvetheconduitaroundthesideofthepatient.ThefollowingstepsoutlinethesuggestedproceduretotunnelfromtheleadanchorsitetotheINSpocket: PRECAUTION:Useextremecaretonotdamagetheleadwiththesharppointofthetunnelingtool.1. Identifythetunnelingroutebetweentheleadincisionandtheneurostimulatorpocket.2. Administerlocalanestheticalongthetunnelingroute.Additionalsedationmaybeadministeredatthediscretionofthephysician.3. Bendthetunnelingtoolasnecessarytoconformtothepatient’scontouralongthetunnelingroute4. Withthestrawinplaceonthetunnelingtool,tunnelfromtheINSpockettotheleadanchorsite.5. Withdrawthetunnelingtoolfromthestraw,leavingthestrawinthesubcutaneoustunnel. PRECAUTION:LeadsorExtensionsshouldberoutedadjacenttooneanotherastopreventchangesinperceivedstimulationfromtheftdetectorsandmetalscreeningdetectors.6. PasstheendoftheLead(s)orExtension(s)throughthestrawfromtheanchorsitetotheINSpocketortothemidpointiftunnelingtotheabdomen.Ateachincisionpoint,leaveastrainreliefloopinplaceastominimizethechancesofleadmigration.7. Removethestrawfromthetunnelbypassingitovertheleads,takingcarenottocausetractiononthemanddisturbtheleadposition.ConnectingLeadtoExtensionIfanextensionisusedtoconnecttheLeadtotheINS,refertothesection“PercutaneousExtensionTunneling”forinstructionsonhowtoconnecttheExtensiontotheLead.
SpinalModulation,Inc. PhysicianImplantManual36ConnectingtheINSThefollowingstepsoutlinetheguidelinestoconnectingaLeadorExtensiontotheINS: PRECAUTION:Donotconnectaleadwithbodyfluidonitscontactsbecausecorrosioncanoccurandcausefailureofthesystem. PRECAUTION:IfthereisaneedtocommunicatewiththeINSpriortoimplantation,donotputtheINSonastainlesssteeltable,ascommunicationmaybedifficult.Thismayprolongtheprocedure.1. Iftheleadcontactscameincontactwithbodyfluidsorsaline,thoroughlycleanwithsteriledeionizedwaterorsterilewaterforirrigationandthendrythemcompletely.2. Usingcleangloves,carefullyslidetheleadorextensionintotheINSheaderuntilthedepthmarkeralignswiththeedgeoftheheader. PRECAUTION:UseonlythetorquewrenchprovidedbySpinalModulationorthedeviceorleadmaybedamagedandunusable.Tightenuntilaclickisheardortheleadmaymakeintermittentcontactwiththestimulator.3. Insertthetorquewrenchthroughthesealplugandtightenthesetscrewbyturningitclockwise,untilthewrenchclicks.4. Carefullyremovethetorquewrenchandverifythattheseptumoverthesetscrewisclosed.Reseattheflapsifitisnotclosed.5. Ifimplantinglessthan4leads,inserttheportplugsineachofthevacantheaderports.Usethetorquewrenchtotightenthesetscrewontheportpluguntilitclicks. PRECAUTION:InserttheleadslowlyintotheheadertopreventdamagetotheINS.Iftheleadneedstoberetracted,retracttheleadslowly.
SpinalModulation,Inc. PhysicianImplantManual37ImplantingtheINSThefollowingstepsoutlinetheprocedureforimplantingtheINS: PRECAUTION:DonotimplanttheINSfacedown.Alwaysimplantwiththelabelfacingup.Failuretodosowillpreventcommunicationwiththeprogrammerand/ormagnet. PRECAUTION:IfusingmorethanINS,implantthematleast15cmapart.Puttingthemtooclosetogethermayinterferewiththeprogrammer’sabilitytocommunicatewitheachoneseparately.1. PlacetheINSintothepocketatadepthnogreaterthan2cmfromtheskinsurface,withthelabelfacingtheskinsurface.2. CarefullycoilexcessleadbehindtheINSoraroundtheINSinloopstoprovidestrainrelieffortheleadandINSconnection. PRECAUTION:CoilingtheleadonthetopsurfaceoftheINS(closesttotheskin)willinterferewiththeabilityoftheprogrammertocommunicatewiththedevice. PRECAUTION:DonotbringthesutureneedleincontactwiththeINS,orleadduringsewingtheINSintothepocketorclosingthepocket.Thecomponentsmaybedamageifthisoccurs.3. TostabilizetheINSwithinthepocket,passasuturethroughthetwosutureholesintheINSandsecureittoconnectivetissue.4. Checktheentiresystembyfluoroscopypriortoclosingtoensureproperpositioningoftheleads.Verifythattheleadshavenosharpbendsorkinks.5. PlacethemagnetintoasterilebagandwaveovertheINS.
SpinalModulation,Inc. PhysicianImplantManual386. Slowlyawakenthepatientandtestforstimulationperceptionandtherebyverifyingthesystemisoperational.NOTE:TheINSoutputmaynotbeidenticaltothetrialneurostimulatoroutput.Alwaysstartstimulatingfromasettinglowerthanthatusedtostimulatewiththetrialneurostimulator.7. EnsurethatthattheINSisawayfromthepocketincisionsutureline,closethepocketincision,andapplyappropriatedressings.8. FilloutthepatientregistrationinformationformandreturnittoSpinalModulation.CheckingSystemIntegrity1. Placethemagnetinasterilepouchandwaveitoverthedevicetostartprogrammercommunication.2. Usingtheclinicalprogrammerinthenon‐sterilefield,programthebasicstimulationparameters,checkthebatterystatus,andchecktheelectrodeimpedancestoensurethereisnoshortoropencircuit.3. Oncethesystem’sfunctionisverified,turntheneurostimulatoroff.CompletingtheProcedure1. Followstandardprocedureforwoundclosureandbandaging.ReplacinganINSThefollowingstepsoutlinethesuggestedproceduretoreplaceanINS:1. TurnofftheINSandverifythatithasbeenturnedoff. PRECAUTION:Exercisecarewhenusingsharpinstrumentsorelectrocauteryaroundleadsortheymightbedamaged.2. OpentheINSimplantsitepernormalsurgicalprocedures.3. RemovethesuturefromtheINSheader,withoutdamagingthelead,andcarefullyremovetheINSfromthepocket.4. CleantheINSheaderandtheleadwithsterilewaterandthenwipewithasurgicalsponge.5. InsertthetorquewrenchthroughtheseptumoftheINSheaderandloosenthesetscrewbyturningitcounterclockwise. PRECAUTION:Whenperformingthefollowingsteps,donotbendtheleadsharplyasthismaycauseleadbreakage.MagnetActivationTargetMagnetmustbewithin3.5cmofINSsurfaceforactivationofcommunication.
SpinalModulation,Inc. PhysicianImplantManual396. GentlyremovetheleadfromtheINSheader;thencleananddryallconnectionsonthelead,ensuringtheyarefreefromfluidandtissue. PRECAUTION:Ifresistanceismetwhileremovingleadsfromtheepiduralspace,donotuseexcessiveforcetoextract.Alwaysperformremovalwiththepatientconsciousandabletogivefeedback. WARNING:Donotremovealeadquickly,asthismayresultinleadbreakageandunintentionalleadfragmentsbeingleftinthepatient. WARNING:Takeproperprecautionswhenhandlingremovedleadcomponents.Treatallusedleadsanddeliverycomponentsasa“biohazard”.7. Ifyouneedtoreplacealead,performthefollowingactions:a. Makeanincisionabovethelocationofthesutureanchor.b. Carefullycutthesuturesfromthesutureanchor.c. Slidetheleadoutoftheepiduralspaceslowly.8. TocompletetheINSreplacementprocedure,see“ConnectingtheLeadtotheINS”.9. Tocompleteleadplacement,see“PlacingaLead”.DisposingofanExplantedDeviceAllexplantedINSsshouldbereturnedtoSpinalModulationforproperdisposal.Todisposeofanexplanteddevice,followthesesteps: WARNING:Donotcrush,puncture,orburntheINSbecauseitmayexplodeorcatchonfire.1. Decontaminatetheexplanteddevice.2. Placeitinacontainerwithabiohazardlabel.3. Includeacompleted“ReturnedProductForm.”(OneispackagedwitheachnewINS)4. Returntheexplanteddeviceto:SpinalModulation1135O’BrienDriveMenloPark,CA94025U.S.A.
SpinalModulation,Inc. PhysicianImplantManual40AppendixA:TrialLeadKit/ImplantLeadKitHowSuppliedThecomponentsoftheSpinalModulationTrialLeadKitandImplantLeadKitareprovidedsterileinadoublepouchassemblyandareintendedforsingleuseonly.DonotresterilizeorreuseanydevicesfromtheLeadKits,foranyreason,becauseofriskofinfectiontothesubjectandmalfunctionofthedevices. PRECAUTION:DonotresterilizetheLeadKitsoranyothersterilecomponentsasitwillcreateariskofinfectionormalfunctionofthedevice.StorageTemperature‐StoretheTrialLeadKitandLeadAccessoriesKitbetween14°F(‐10°C)and122°F(50°C).Temperaturesoutsidethisrangemaydamagethecomponents.Ifatemperaturedeviationhasoccurred,donotusetheproduct.Sterilization‐TheTrialLeadKit,ConnectorCable,andallLeadKitAccessorieshavebeensterilizedusingethyleneoxide(EO)gas.PackageContents(1)Trial/ImplantLead50cm/90cm(1)22cmSmallCurveDeliverySheath(1)22cmBigCurveDeliverySheath(1)Guidewire(1)ComplexCurveStylet(1)4.5”14GaugeNeedle(2)SoftTissueAnchors(1)PhysicianImplantManual
SpinalModulation,Inc. PhysicianImplantManual41DeviceSpecificationTheLeadhasfourelectrodesonthedistalendandtheproximalendfitsintoafourconductorconnectorontheConnectorCableorintotheINSports.TheComplexCurvedStylethasbeeninsertedintotheproximalendoftheleadandtheleadhasbeenpre‐loadedintoa22cmSmallCurveDeliverySheathforuserconvenience.AnillustrationoftheTrialLeadisgiveninFigure1.Figure1:LeadshowingfourproximalelectricalconnectorsandfourradiopaqueelectrodesTheapproximatemeasurementsforaTrialLeadarepresentedbelow:ProximalElectricalConnector..................Quadrapolar,in‐lineCentertoCenterConnectorSpacing ........3.3mm(0.130”)Diameter ..................................................1.0mm(0.040”)Length ......................................................50cm(20”)or90cm(35”)NumberofElectrodes……………………........4ElectrodeShape…………………………….........CylindricalElectrodeLength ......................................1.25mm(0.050”)EdgetoEdgeSpacing ...............................5mm(0.200”)CentertoCenterSpacing.........................6.25mm(0.250”)ArrayLength………………………………….........20mm(0.790”)BallTipDiameter......................................1.5mm(0.060”)StyletWireDiameter………………...............0.25mm(0.010”)DCLeadImpedance(50cm/90cm/Extension)….<20Ω/<35Ω/<60Ω
SpinalModulation,Inc. PhysicianImplantManual42AppendixB:TrialNeurostimulatorDeviceDescriptionSeetheTrialNeurostimulatorManualforthefulldescriptionofthedevice.TheexternalTrialNeurostimulator(TNS)providesenergyandcontrolselectricalsignalsdeliveredtotheLeads.TheTNSdeviceisintendedtobeconnectedtotheLeadsandwornbythesubjectforupto30daysduringthestudyperiod.ThedeviceisintendedtobeconnectedtotheSpinalModulationConnectorCable.Itisnotcompatiblewithothercablesfromothermanufacturers.TheexternalTNSdevicehasabeltclipthatcanbeusedorthesubjectmaychoosetouseaflexible,elasticbandagetosecuretheirTNSdeviceduringthetrialperiod.ThepatientshouldbeadvisednottoallowtheTNStomakedirectcontactwithskin.PackageContents(1)TrialNeurostimulator(1)TNSManualDeviceSpecificationsSpecificationsRangeStepSizeDefaultValuePulseAmplitude‐PA(µA)(Dependingonmeasuredimpedance)0–6000µA25µA:0‐2000µA50µA:2000‐6000µA0µAMaximumPulseAmplitude‐Max(µA)ProgrammablebyPatientSameasPASameasPA0µAPulseWidth–PW(µs)40–720µs10µs40µsPulseFrequency‐PF(Hz)4–100Hz2Hz60Hz
SpinalModulation,Inc. PhysicianImplantManual43HandlingStorageConditions:‐10°C‐50°CHumidityRange:10–93%CleaningInstructionsforHealthcareProfessional:FordisinfectingtheTNSsurfacesaftergrossfilthandheavysoilloadshavebeenremoved,sprayCavicideorequivalentontoapapertowel,andthenwipethesurfaceoftheTNSwiththewetpapertowel.Allowthesurfacetoremaindampfor2minutes.Drythesurfaceusingadrypapertowel.DonotimmersetheTNSinliquid.AdvisethepatientnottocleantheTNSwithexcessiveliquid.AdampclothmaybeusedtowipetheTNS,ifnecessary. WARNING:AlwaysweartheTNSontheoutsideofclothingasthematerialmaycauseskinirritation.
SpinalModulation,Inc. PhysicianImplantManual44AppendixC:ImplantableNeurostimulatorHowSuppliedTheAxium™ImplantableNeurostimulatorisprovidedsterileinadoubletrayassemblyandisintendedforsingleuseonly.Donotresterilizeorreuse,foranyreason,becauseofriskofinfectiontothepatientandmalfunctionofthedevices. PRECAUTION:DonotresterilizetheINSasitwillcreateariskofinfectionormalfunctionofthedevice.DeviceDescriptionTheImplantableNeurostimulatorisafourchannelneurostimulatorthatisonlycompatiblewithSpinalModulationImplantLeadsandLeadExtensions.Ithasfourportstoallowforstimulationofuptofourleadssimultaneously.IthasanantennaintheheaderthatallowswirelesscommunicationwiththedeviceusingtheSpinalModulationClinicalProgrammerorPatientProgrammer.PackageContents(1)ImplantableNeurostimulator(3)LeadPortPlugs(1)TorqueWrench(1)SterileMagnetSleeve(1)MedicalAlertCard(1)ReferencetoImplantManualDeviceSpecificationsOutputoftheINSisequivalenttotheoutputoftheTNS.Thedeviceisprogrammedincurrent,impedanceismeasuredbythedevice,andtheappropriateoutputvoltagematchestheimpedanceandcurrentprogrammed.SpecificationsRangeStepSizeDefaultValuePulseAmplitude‐PA(µA)(Dependingonmeasuredimpedance)0–6000µA25µA:0‐2000µA50µA:2000‐6000µA0µAMaximumPulseAmplitude‐Max(µA)ProgrammablebyPatientSameasPASameasPA0µAPulseWidth–PW(µs)40–720µs10µs40µsPulseFrequency‐PF(Hz)4–100Hz2Hz60Hz
SpinalModulation,Inc. PhysicianImplantManual45TherapyAccuracy.....................................10%overtherangeof300to6000µAImpedanceMeasurementAccuracy ........5%overtherangeof400to2000OhmsHeight.......................................................6.52cm(2.57in)Width .......................................................4.77cm(1.88in)Thickness..................................................1.10cm(0.43in)Volume.....................................................31cm3(1.89in3)MaximumConnectorStrength ................10NNumberofChannels ................................4PowerSource ...........................................CFx,lithium‐carbonmonofluorideStorageTemperature...............................‐10°C(14°F)to50°C(122°F)StorageHumidity .....................................10%to90%HandlingStorageConditions:‐10°C‐50°CHumidityRange:10–90%Handling:Beforeimplantation,onlywipewithsterilewateranddonotuseanycleaningagents. PRECAUTION:Beforeimplantation,donotusechemicalsoranycleaningagentstowipetheINS.Thismaycauseirritationorinflammationattheimplantsite.DeviceLongevityForinformationregardingdevicelongevity,contactSpinalModulation.
SpinalModulation,Inc. PhysicianImplantManual46TheAxium™NeurostimulatorSystemcomplieswiththefollowingInternationalStandards:• IEC60601‐1:2005• IEC60601‐1‐11:2010• IEC60601‐1‐2:2007• ISO14708‐1:2000• ISO14708‐3:2008CompanyandAuthorizedRepresentativeContactInformationSpinalModulation,Inc.1135O’BrienDriveMenloPark,CA94025U.S.A.Telephone:(650)543‐6800(24‐hoursupportline)Fax:(650)327‐2336Email:clinicalsupport@spinalmodulation.comHealthlinkEuropeB.V.DeTweeling20‐22‘sHertogenbosch5215MCTheNetherlandsTelephone:+31135479300Fax:+31135479301AuthorizationtoaffixtheCEmarkgrantedin2011

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