Spinal Modulation orporated MN0700 Clinical Programmer User Manual LP0014 Rev Draft FCC CProg

Spinal Modulation, Incorporated Clinical Programmer LP0014 Rev Draft FCC CProg

Contents

Revised user manual MN-0700

ClinicalProgrammerModelMN0700UserManualSpinalModulation,Inc.1135O’BrienDriveMenloPark,CA94025USACAUTION–InvestigationalDeviceLimitedbyFederal(US)LawtoInvestigationalUseCopyright©June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.LP0014RevE,June2011
2TABLEOFCONTENTSEXPLANATIONOFSYMBOLSONPRODUCTORPACKAGELABELING....................................................................... 4INTRODUCTION........................................................................................................................................ 5INDICATIONSFORUSE ............................................................................................................................... 5DESCRIPTION........................................................................................................................................... 5WARNINGS............................................................................................................................................. 6PRECAUTIONS ......................................................................................................................................... 7CLINICALPROGRAMMERSYSTEMOVERVIEW ................................................................................................. 8CLINICALPROGRAMMERFEATURES .............................................................................................................. 8MAGNET ................................................................................................................................................ 9CHARGINGTHECLINICALPROGRAMMERBATTERY........................................................................................... 9PROGRAMMERPOWERUP....................................................................................................................... 10MAINMENU......................................................................................................................................... 10DEMO ................................................................................................................................................. 10PROGRAMMERSETUP ............................................................................................................................. 10CHANGETHEDATE................................................................................................................................. 11CHANGETHETIME ................................................................................................................................. 11SWITCHTOFCEPROGRAMMER ............................................................................................................... 11ESTABLISHINGCOMMUNICATIONWITHTHENSDEVICE .................................................................................. 11BACKTOMAINMENU ............................................................................................................................ 12NAVIGATIONANDSCREENELEMENTS.......................................................................................................... 12NEUROSTIMULATORDASHBOARD.............................................................................................................. 12PROGRAMMERSTATUSBAR ..................................................................................................................... 13WORKSPACENAVIGATION ....................................................................................................................... 13TEMPORARYANDPERMANENTPROGRAMMING ........................................................................................... 14MOREONEDITINGTEXTFIELDS ................................................................................................................. 14USINGTHEWORKSPACES......................................................................................................................... 15PROFILEWORKSPACE.............................................................................................................................. 15PATIENTINFORMATIONTAB[PROFILE>PATIENT] ....................................................................................... 15CLINICINFORMATIONTAB[PROFILE>CLINIC]............................................................................................. 16STIMULATORINFORMATIONTAB[PROFILE>NS] ........................................................................................ 16LEADSINFORMATIONTAB[PROFILE>LEADS] ............................................................................................. 17SYSTEMINFORMATIONTAB[PROFILE>SYSTEM]......................................................................................... 17STIMWORKSPACE.................................................................................................................................. 18STIMTABS[STIM>TARGETNAME] ..........................................................................................................18IMPEDANCETABS[STIM>IMPEDANCE] .....................................................................................................21MAPWORKSPACE.................................................................................................................................. 21GROUPWORKSPACE............................................................................................................................... 21LEADTABS[GROUP>GROUPNAME]........................................................................................................ 22AUTHORIZEDEUROPEANREPRESENTATIVE .................................................................................................. 22COMPANYCONTACTINFORMATION ........................................................................................................... 22
3GUIDANCEANDMANUFACTURER’SDECLARATION.......................................................................................... 23ELECTROMAGNETICEMISSIONS ................................................................................................................23ELECTROMAGNETICIMMUNITY ................................................................................................................24APPENDIXI:PROGRAMMABLEPARAMETERSANDVALUES ............................................................................... 27APPENDIXII:INSBATTERYLIFE ................................................................................................................ 28APPENDIXIII:TROUBLESHOOTING ............................................................................................................. 37
4ExplanationofSymbolsonProductorPackageLabeling ModelNumberSerialNumberReadtheManualConsulttheManualContentsofPackageareNon‐SterileManufacturingDateManufacturer Warning.Payattention.ProtectedagainstElectricShockNotwaterproof.AppliestotheProgrammerwhenitisnotinitscarryingcase.Limitedwaterproof.AppliestotheTNS.AppliestotheProgrammerinitscarryingcase.TurnstheProgrammerONandOFF.TurnsstimulationOFFontheTNS.KeepDryStorebetween‐10°Cand50°C(14°Fand122°F)Storebetween0and93%humidityThedeviceisaradiotransmitterMagnet.ShowsthelocationoftheProgrammermagnet.AustraliaC‐tickAuthorizedEuropeanRepresentative
5IntroductionTheClinicalProgrammer(MN0700)ispartoftheSpinalModulationNeurostimulatorSystem.ItisintendedtobeusedbytheclinicalinvestigatororaSpinalModulationrepresentativetoqueryandprogramtheNeurostimulator(NS),toretrievedatafromtheNSandtoallowforadjustmentofthepatient’stherapy.ThisUserManualgivesdetailedinstructionsonhowtousetheClinicalProgrammersafely,howtorechargeitandhowtouseittosetupthepatient’spainmanagementtherapy.IndicationsforUseTheSpinalModulationNeurostimulatorSystemisindicatedasanaidinthemanagementofchronic,intractable,neuropathicpainofthelowerlimbs‐includingunilateralorbilateralpain,associatedwiththefollowingconditions:radicularpain,peripheralneuropathies.DescriptionPatientswhoareindicatedforSpinalModulation’sImplantableNeurostimulatorSystem(INS)systemwillfirstundergoatrialperiodusinganexternalTrialNeurostimulatorSystem(TNS)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.Althoughtheleadsandstimulatorhardwareuseddiffer,theprogrammerhardwareandinstructionsforprogrammingtheTNSandINSdevicesarethesame.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.ForspecificdescriptionoftheTNSandINSsystemcomponentsandimplantprocedures,refertotherelevantlabeling.TwoprogrammersareavailabletointeractwiththeNSdevice.1. TheClinicalProgrammerdescribedinthisusermanualisusedtoprogramthestimulationparametersfortheNS,asdeterminedbytheinvestigator.TheNSdeliverstheprogrammedstimulationparameters(energy)totheimplantedLeads.2. ThePatientProgrammerallowsthepatienttoadjustthestimulationsettingsoftheNSdeviceswithinlimitspresetbytheinvestigator.ThePatientProgrammeralsoallowsthepatienttoturnstimulationoff,ifnecessary.Forfurtherinformationandinstructionsrelatedtothepatientprogrammer,refertotherespectiveusermanual.
6 WarningsTheWarningslistedbelowpertaintotheClinicalProgrammeronly:• TheinvestigatormustbetrainedbySpinalModulationpersonnelbeforeusingtheClinicalProgrammer.• DonotusetheClinicalProgrammerwithaNSdevicethatappearstobefaultyorfailstoproperlycommunicate.• ImproperuseoftheClinicalProgrammermaycauseirreversibleinjurytothepatient.Allsubjectsaretobeawakeandconversantduringtheproceduretominimizethelikelihoodofanynervedamage.• AlwayssettheNSdeviceamplitudeto0µAwhenrepositioningaleadorattachingtheConnectorCabletotheexternalTNS.Whenrestartingstimulation,increasetheNSamplitudeslowlyuntilthedesiredparesthesiaisachieved.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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‐MN0700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.
7 PrecautionsThefollowingprecautionsshouldbetakentoavoiddamagetotheClinicalProgrammerandtoassureproperfunction:• DonotdropormishandletheClinicalProgrammer.PhysicaldamagetotheClinicalProgrammermayimpairitsfunction.• DonotspillfluidsonorwashtheClinicalProgrammer.Excessivemoisturemayimpairitsfunction.Ifcleaningisnecessary,removesoilwithasoftdampcloth.• DonotuseabrasiveorcausticcleaningproductsontheClinicalProgrammer.• DonotattempttoopenthecaseoftheClinicalProgrammer.AttemptstoopenthecasemayexposetheClinicalProgrammertoelementsthatalteritsfunction.• TheClinicalProgrammerhasaninternalmagnet.KeeptheClinicalProgrammerawayfromanycreditcards,harddrivesormagneticstoragedevicesasitmaydemagnetizethem.• DonotoperatetheClinicalProgrammeroutsidethetemperaturerangeof‐5°Cto45°C.Rapidtemperaturechangesmayaffectproperdeviceoperation.• DonotstoretheClinicalProgrammeroutsidethetemperaturerangeof‐10°Cto50°C.• DonotleavetheClinicalProgrammerinacarorotherplaceswheretemperaturescanexceed50°C.• DonotburnorotherwisedisposeoftheClinicalProgrammer.Firemaycausetheinternalbatterytoexplode.• DonotallowunauthorizeduseoftheClinicalProgrammertoavoidinjurytopatients.• TheNSdevicecanonlybeprogrammedusingSpinalModulation’sClinicalorPatientProgrammer.Donottrytouseanyothermanufacturer’sdevicetoprogramit.• DonotusetheClinicalProgrammerorNSinthepresenceofexplosiveorflammablegasesasthismaycauseseriousinjury.• IfthereisanyconcernregardingtheproperfunctionoftheSpinalModulationNSSystem,pleasecontactyourSpinalModulationrepresentative.• DonotusetheProgrammerChargerifthepowercordisdamaged,excessivelywornorfrayed.ThismaycauseinjuryordamagetheProgrammer.• Frequentprogrammingoftheimplanteddevicewillcausethebatterytodepletefaster.Avoidunnecessaryprogramming.• TheTNSshouldalwaysbeworneitheroutsideofclothingoroutsidethedressingholdingtheleadsinplace.
8ClinicalProgrammerSystemOverviewTheClinicalProgrammerallowsyoutoestablishtwo‐waycommunicationwiththepatient’sNSdeviceforqueryingandprogramming.Itisaportable,hand‐helddevicethatcanbepluggedintoapoweroutletorbepoweredbyaninternalbattery.ThebatteryisrechargeableusingtheProgrammerChargerprovidedandapoweroutlet.TheClinicalProgrammerSystemincludes:• ClinicalProgrammer(withStylus)MN0700• ProgrammerChargerMN3400• ExternalAuxiliaryMagnetMN3300• CarryingCaseMN3500• ClinicalProgrammerUserManual(thisdocument)  Stylus ProgrammerChargerClinicalProgrammerTheCarryingCasewillkeeptheProgrammerdry.StoreandtransporttheProgrammerintheCarryingCasewhenyouarenotusingit.ClinicalProgrammerFeaturesWiththeClinicalProgrammer,youcan:• TurnOFFallstimulation.• TurnstimulationONforuptofourleadsandmeasureleadimpedance.• Changestimulationsettingsforeachlead.• ConfigurePatientControlledTherapysettingsforeachlead.• Enterpatientandleadidentificationinformation,clinicianandclinicnameandcontactinformation,andclinician’snotes.• Createandnamegroupsofstimulationsetswitheachgroupcontaininguptofourleadswithdifferentsettingsoneachlead.• Performarealtimetrial(test)toassessthepatientstimulationresponseforeachlead.• Acquireidentification,diagnostic,andhistoricinformationabouttheNSdevice.
9MagnetAmagnetisbuiltintotheClinicalProgrammer.ItislocatedonthebacksideoftheProgrammerunderneaththeindentwiththemagnetsymbol(shownbelow).TheNSsystemhasthecapabilityofdetectingthepresenceofamagnet.ThemagnetputstheNSdeviceincommunicationmode,allowingittoconnecttotheProgrammer.Analternatefunctionofthemagnetisthatbyholdingthemagnetoverthedevicelongenough,allstimulationtherapywillbeswitchedoff.(Referto“Workspace‐Profile>System”sectionformoreinformation).  PRECAUTION:Keeptheprogrammermagnetawayfromcreditcards.Itmayerasethemagneticstripandrenderthecarduseless.ChargingtheClinicalProgrammerBatteryYouwillneedtheProgrammerChargerprovided,tochargethebatteryinyourClinicalProgrammer.Ittakesapproximately2–4hourstofullychargethebattery.Thebatterychargelevelisindicatedinthe“ProgrammerStatusBar”atthebottomofthescreen.1. ConnecttheChargertoapoweroutlet.Input:100‐240VAC,50‐60Hz,0.6AOutput:5V 3.0A2. ConnecttheChargertoyourProgrammer.3. Whenthebatteryischarging,thebatteryicononthescreencontains“AC”.Whenthechargingiscomplete,theindicatornexttothebatteryiconwillbeatapproximately100%.WhentheClinicalProgrammerisconnectedtoapoweroutletasdescribedabove,itispoweredbytheoutletandwillnotusebatterypower.WhentheClinicalProgrammerischarging,theProgrammerbatteryiconreflectsthecurrentstatusofthebattery.ConnecttheClinicalProgrammertotheChargerandattachtoanoutletregularlytokeepitcharged.
10ProgrammerPowerUpTurntheClinicalProgrammerONbypressingthe““button.TheMainMenuwillbedisplayed.NOTE:IftheClinicalProgrammerscreendoesnotturnon,followtheinstructionsforchargingthebattery,andtryagain.MainMenuTheMainMenudisplaysthreeprimaryfunctions:• Demo:Putsthesystemintoastand‐alonedemomodeallowingyoutouseallprogrammerfunctionswithoutitbeingconnectedtoaNS.• ProgrammerSetup:AllowsyoutosettheClinicalProgrammerdateandtime,activatetheFCEWorkspaceontheProgrammer,andsetandmodifytheProgrammerpassword.• ConnecttoStimulator:OpensascreenthatallowsyoutocommunicatewiththeNSdevice.TheMainMenuidentifiesthedeviceastheSpinalModulationClinicalProgrammer.Furthermore,Programmer’sSerialNumber,SoftwareVersion,BasestationFirmwareVersionandManufacturingdatearedisplayed.AtthebottomoftheMainMenu,thestatusbardisplaystheProgrammer–NSconnectionstatus,thebatterychargelevelandthetime.RefertothesectionontheProgrammerStatusBarinthisUserManual.DemoSelect“Demo”ontheMainMenutoinitiateDemomode.ButtonswillbepurpletoindicatethattheProgrammerisoperatinginDemomode.NoNSdeviceisneededforthismode—justtheProgrammer. TheProgrammerwillhavesimulatedNSdataonitandwillsimulatetheRFcommunicationwiththeNS. ThismeansthatatthestartofeveryDemosession,thedatawillalwaysbethesame.ProgrammerSetupSelect“ProgrammerSetup”ontheMainMenutogetthesetupscreen.
11ChangetheDateSelectthedropdownarrowontherightsideofthe“SetDate”box.Acalendarwillappearandyoucansetthemonth,dayandyearusingyourstylus.ChangetheTimeTochangethetime(24hourformat),firstselectthehourorminutefieldthatyouwouldliketochange.Tochangetheselectedfield,usethe“Up”or“Down”arrowstoincrease,decreaseortogglethesetting.NOTE:EstablishingaconnectionupdatestheNSdevice’sclocktothenewlysettime.SwitchtoFCEProgrammerBycheckingthisboxtheClinicalProgrammerwillgetadditionalfunctionality,whichshouldonlybeusedbySpinalModulation’sFieldClinicalEngineersandStaff.EstablishingCommunicationwiththeNSDeviceTochangethepatient’sstimulationsettings,youmustfirstestablishcommunicationbetweentheClinicalProgrammerandthepatient’sNSdevice.1. MakesurethattheClinicalProgrammeristurnedonandtheMainMenuscreenisdisplayed2. Press“ConnecttoStimulator”ontheMainMenu.3. Selectthetextboxnextto“StimulatorSN:”4. Entertheserialnumberusingthepop‐upkeyboard.TheProgrammeriscasesensitivesouseuppercaselettersonly.IftheserialnumberformatisvalidforaNSdevice,the“Connect”buttonwillbeenabled.5. Pressthe“Connect”button.Afterpressingthe“Connect”button,the“Cancel”buttonbecomesenabled.IftheCancelbuttonispressed,thetelemetryconnectioniscancelled.
126. MovetheClinicalProgrammermagnetovertheNSdeviceinacircularmotiontoconnect.Theindicatorstatusbaronthebottomleftofthescreenwilldisplay“Connected”iftheconnectionattemptissuccessful.IftheProgrammercouldnotcommunicatewiththeNSdevice,anerrormessagewillappearand“Disconnected”willbedisplayedinthestatusbar.NOTE:Ifafter2minutestheClinicalProgrammerhasfailedtocommunicatewiththeNSdevice,theprogrammerwillautomaticallycanceltheconnectionattempt.TrytocommunicatewiththeNSdevicebypressingthe“Connect”buttonagainmovingthemagnetsymbolontheClinicalProgrammerovertheNSdeviceinacircularfashion.Whenasuccessfulconnectionisestablished,theProgrammerchimesandtheNSdevicewillbequeried.7. ForthedurationoftheprogrammingsessionkeeptheClinicalProgrammerwithin6feetoftheNSdevice.Movingtheprogrammertoofarawaymaycausetelemetryconnectiontobelost.BacktoMainMenuLocatedatthebottomrightsideoftheProgrammerConnectwindow,the“Exit”buttonisusedtoreturntotheMainMenu.NavigationandscreenelementsNeurostimulatorDashboardOncetheselectedNSdeviceisconnectedtotheClinicalProgrammer,theNSDashboardisdisplayedinthescreen’sheaderproviding:• PatientID:thepatient’sIDNumber.• StimulatorSerialNumber:theNSdevice’sserialnumber.• Alertsbutton:ThebuttonturnsorangewhenanyoftheNSSystemAlertsbecomeactive.Whenthe“Alerts”buttonisorange,pressthebuttontodisplayawindowshowingdetailsofalltheSystemAlerts.Anexampleofthescreenshotisshowntotheright.
13ProgrammerStatusBarLocatedatthebottomoftheClinicalProgrammerscreen,theProgrammerStatusBardisplays:• Programmer‐NSConnectionStatus:DisplaysthestatusofthecommunicationbetweentheClinicalProgrammerandtheNSdevice:“Connecting”isdisplayedwhenestablishingaconnection.“Connected”isdisplayedwhenthereiscommunicationbetweentheClinicalProgrammerandtheNSdevice.“Disconnected”isdisplayedwhenthereisnocommunicationbetweentheClinicalProgrammerandtheNSdevice.• ProgrammerBatteryLevel:DisplaystheClinicalProgrammerbatterychargelevel.ItisrecommendedthatyourProgrammerbeconnectedtothepowersupplyprovidedandattachedtoanoutletwhennotinuse.• ProgrammerClock:Displaysthetime.SeeUserManualsectiononChangetheTime.WorkspaceNavigationOncetheNSisconnected,tabsaredisplayedforthesystems’fourmainworkspaces(“Profile”,“Stim”,“Map”and“Group”).TheWorkspacesareusedtoviewandprogramtheNStherapysettingsandtoobtaindiagnosticinformation.Arecordoftheprogrammedsettingsanddiagnosticinformationisgeneratedaftereverysession.AfifthWorkspacelabeled“FCE”willonlyappearwhenFCEmodeisON.Workspacescreensandsub‐screensarenavigatedbyselectingthelabeledtabs.Onceselected,atabwillbehighlightedinyellow.LocatedatthebottomofeachoftheWorkspacesarethe“ALL”,“Program”and“Exit”buttons.• Exitbutton:isusedtoclosethecurrentwindow,endthepatienttherapysession,andreturntotheMainMenu.NOTE:ReturningtotheMainMenuorturningoffyourProgrammerwillnotchangeanyoftheprogrammedNSsettings.NOTE:Whenprogrammingiscomplete,selectthe“Exit”buttontoconservepower.• Programbutton:programsallchangesmadewithinthecurrentWorkspace.• ALLbutton:isusedtoturnallstimulationoff.
14TemporaryandPermanentProgrammingWheneverachangeismadetoaparametervalueorotherdatafieldwhiletheNSiswithintelemetryrange,thisvalueimmediatelybecomestemporarilyactive.Thecorrespondingvalueordataselectionappearinaredboldunderlinedfont.Temporaryprogrammedvaluesortextdatacanbepermanentlyprogrammedbypressingtheprogrambutton.Thefontcolorchangesfromredtoblack.NOTE:WhenleavingaWorkspacewhilevaluesaretemporarilyactiveyouwillbepromptedtoeitherprogramthesevaluespermanentlyorcancelthependingchanges.NOTE:ParameterscanbetemporarilyactiveonmultipletabsofthesameWorkspace.MoreoneditingtextfieldsNOTE:Selectingatextfieldwillpopupakeyboardatthebottomofthescreen,allowingtheinformationtoberevised.Toclosethekeyboardaftermodifyingtheentry,pressthekeyboardkeycenteredinthebluebaratthebottomofthescreen.Whiletextfieldsarebeingeditedtheyappearinablackboldfont(nounderline).Atthesametimetotherightofthetextfieldareddotisshownindicatingthateditingisinprogress.Editingcanbeinprogressformultiplefieldsatthesametime.Onceeditingforafieldiscomplete,tapthered‐dottomakethechangetemporarilyactive.Thereddotdisappearsandthefontchangesfromblackboldtoredboldunderlined.Onlyuponpressingtheprogrammingbuttondoesthechangebecomepermanentlyprogrammedandthefontcolorchangesfromredtoblack.
15UsingtheWorkspacesProfileWorkspacePressthe“Profile”tabtoaccesstheProfileWorkspace.TheProfileWorkspaceisdividedintofivetabs(“Patient”,“Clinic”,“NS”,“Leads”and“System”)whichareusedto:• Enterpatientinformation;• Entercliniciancontactinformation;• EnterNSdeviceinformation;• Enterleadidentificationinformation;• Changebasicsystemparameters;PatientInformationTab[Profile>Patient]Enterormodifythepatientinformationinthefieldsprovided:  • PatientName:Enterthepatient’snameusingtheon‐screenkeyboard.• ID:Enterthepatient’suniqueidentificationusingtheon‐screenkeyboard.• DateofBirth:Enterthepatient'sdateofbirthusingthedrop‐downcalendar.• PrimaryandsecondaryDiagnosis:Selectthepatient'sdiagnosisfromadrop‐downlist(RefertoAppendixIforselectionset)• Notes:Enternotesifneeded.
16ClinicInformationTab[Profile>Clinic]Enterormodifythephysicianandclinicinformationinthetextfieldsprovided:• PhysicianName• ClinicName• Clinicafterhourscontactphonenumber• ClinicPhonenumber• ClinicEmail• ClinicAddressStimulatorInformationTab[Profile>NS]TheNStabprovidesasummaryofinformationrelatedtotheNS.• DateofImplant:EntertheStimulatordateofuseusingthedrop‐downcalendar.• Implantbatteryvoltage:thecurrentbatteryvoltageisautomaticallydisplayedhere.• History:showsrecentprogramminghistory.NOTE:ThebatteryinformationpertainstoanINSanddoesnotpertaintotheTNS.
17LeadsInformationTab[Profile>Leads]Lead1throughLead4arethedefaultlabelsusedtoidentifytheimplantedleadsinthe“Stim”Workspace.Itisrecommendedthatthesenamesbechangedintosomethingmoremeaningful,forexamplethebodyregionitcovers.• TargetName:foreachoftheimplantedleads,enterthebodyregioncovered(textfield).ForeachoftheleadsentertheLotandModelnumber:• Lot#:enterthelastfourdigitsoftheLotnumberfoundontheleadpackaging.• Model#:entertheleadModelnumber.SystemInformationTab[Profile>System]Fromthesystemtabthefollowingsystemparameterscanbemanaged:• PeriodicImpedanceinterval:settheperiodicitywithwhichyouwantthesystemtomeasureleadimpedance.• Follow‐upPeriod:Acalculatedfieldwhichdisplaystherecommendedfollow‐uptimebasedontheprogrammedsettings.Itisanindicatorofwhentheprogrammerwillrunoutofmemoryandwillbegintooverwriteolddata.• RampDuration:RampdurationishowlongittakesfortheNStoreachtherequestedamplitude.Ifsetto8seconds,theNSwilltake8secondstogetfrom0totherequestedamplitudewhenaleadisswitchedfromnotenabledtoenabled.Rampingalsooccurswhenthestepbetweenthecurrentamplitudeandthenextamplitudeisgreaterthan100mV.• MagnetTurnoffTime:allowsyoutocontrolhowlongittakesbeforeamagnetheldoverthedeviceswitchesoffdeliveredtherapy.
18StimWorkspacePressthe“Stim”tabtoaccesstheStimulationSettingsWorkspace.TheStimulationSettingsWorkspaceisdividedintofivetabswhichareusedto:• Activate(turnon)uptofourleads• Adjustelectrodeconfigurations• Measureimpedance• Setnominalvaluestobeginstimulation• Performtrialmapping• ConfirmtheresponseandsensationofspecificbodyregionstobestimulatedStimTabs[Stim>TargetName]TheStimtabsarethemaintabsfromwhichtherapyiscontrolledandprogrammed.Thiscanbedoneeithertemporarily(testing)orpermanently.• Selectgroup:selectthegroupforwhichyouwanttochangethestimulationsettings.NOTE:intheGroupWorkspace,uptofourdifferentgroupscanbedefinedeachwiththeirownstimulationparameters.Agroupcanbelinkedforexampletoaspecificactivityorposture.RefertotheGroupWorkspacesectioninthismanualformoreinformation.• Selectthetab:labeledwiththetargetforwhichyouwanttoadaptstimulationparameters.(Inthesamplescreeneg.“LFoot”)NOTE:Thereareuptofourtabsthatcanbelabeledwiththebodyregioninwhichstimulationwiththecorrespondingleadistargeting(definedinProfile>Leads).Foreachbodyregion(lead)stimulationcanbeadjustedindependently.• ElectrodeConfiguration:Eachleadhasfourelectrodeseachofwhichcanbeprogrammedwithapositiveornegativepolarity,orbeprogrammedasneutral(off).TheremustbeatleastonepositiveandonenegativeelectrodebeforetheClinicalProgrammerallowstheamplitudetobeadjustedandfortheleadtobeenabled.1. Selectoneofthefourelectrodesbyclickingonitusingthestylus.Clickingoncewillturntheelectrodepositive(“+”),clickingittwicewillturnitnegative(“‐“)andclickingitthreetimeswillturnitNeutral(“N”)again.Toexitfromtheelectrodeeditingmode,clickontheneighboringImpedancebox.2. Continue,bysettingeachofimplantedleadswithatleastonepositiveandonenegativeelectrodeforeachbodyregiontobetreated.• Impedance:Pressthe“InstantImpedance”button(“Ω“)tomeasurethelead’simpedance.Oncepressed,theimpedancevaluewillbedisplayedunderneaththebutton.IfyouwanttheNS
19tousethisInstantImpedancevaluefortherapydelivery,pressthe“TransferInstantImpedance”button(“Æ“).NOTE:Thepatientmayfeeltheeffectoftheimpedancemeasurement.Alertthepatienttothepossiblestimulation.NOTE:Atransferredimpedancevalueisrequiredbeforeotherstimulationparameterscanbeselected.• Enable:Select“ON”toenabletheleadsothatitprovidesstimulationtherapytothepatient.Select“OFF”iftheleadisnotbeingused.o WhenEnableisON,the“ON”buttonwillturnthecolorgreen.o WhenEnableisOFF,the“OFF”buttonwillturnthecolorblack.o Thebuttonborderisrediftheactivationstateisdifferentfromtheprogrammedvalue. WARNING:OnceEnableisONforthistarget,anyparameterchangewillbeimmediatelyactive.NOTE:Ifaleadisenabledonanonactivetabofthe“Stim”Workspace,thetabwillturnthecolorgreen.Theactivetabstaysthecoloryellow.NOTE:Theleadisdisabledandtheamplitudeisautomaticallychangedtozerowhentheleadelectrodeconfigurationchanges.Theleadelectrodeconfigurationmustbevalidpriortoactivatingthelead.Avalidleadconfigurationmustincludeatleastonepositiveandonenegativeelectrode.
20• Location:Enterthespinallevelwherestimulationtherapyisdeliveredbythistriallead• PulseParameters:Toselectandchangepulseparameters,firstpressthedesiredincrementlevel:Fine(>),Medium(>>),Coarse(>>>). Amplitudesbelow2.0mA(>:25µA,>>:50µA,>>>:200µA) Amplitudesabove2.0mA(>:50µA,>>:100µA,>>>:400µA) PulseWidth(>:10µs,>>:40µs,>>>:100µs) Frequency(>:2Hz,>>:4Hz,>>>:10Hz) TheUP(^)andDown(∨)buttonsnexttothespecificpulseparameterwillallowtheusertochangethesettingatthedesiredincrements.Thefollowingtableliststhepulseparameters,theirrange,incrementsanddefaultvalue: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• MaximumAmplitude:Enterthemaximumstimulationamplitude,fromtheclinicallysetamplitudeupto6.0mAthatthepatientisallowedtosetforeachlead. WARNING:Unlessthestimulationsettingsareknownforaspecificpatient,startwithaPulseAmplitudeof0µA.• StimulusResponse:Allowsyoutoassignadescriptortoasetofprogrammedpulseparameters.Thedescriptoriscomposedofabodyregionwherethesensationisfeltandadescriptionofthesensation.(Eg.UpperBack&MassagingÆUpperBackMassaging).AStimulusResponsemustbeselectedinordertoProgramthesetofpulseparameters.TheLoadOtherbuttonpullsdownadropdownmenuandallowstheusertoloadanotherStimulusResponsethathasbeenpreviouslysavedforthatlead.NOTE:Whenrestartingstimulation,increasetheamplitudeslowlyuntilthedesiredeffectisachieved.
21ImpedanceTabs[Stim>Impedance]Theimpedancebutton(Ω)initiatesimpedancemeasurementsbetweenadjacentelectrodecouplesinalloftheconfiguredleadsanddisplaysontheImpscreen.MapWorkspacePressthe“Map”tabtoaccesstheMapWorkspace.TheMapWorkspaceallowsyoutodefinewhichleadconnectstoeachoftheNSports.ItthereforeprovidestheabilitytoautomaticallymovesavedsettingsfromonePorttoanother.Eachleadisidentifiedbyitslocation(spinallevel)enteredintheStimWorkspace.GroupWorkspacePressthe“Group”tabtoaccessGroupWorkspace.TheGroupWorkspaceisdividedintofourtabs(Groups)bydefaultnamed“Awake”,“Sleeping”,Exercising”and“Sleeping”).EachtabsummarizesGroupspecificsettingsforeachoftheimplantedleads.TheseGroupscanbeeasilyprogrammedasneededbythepatientusingthePatientProgrammer.
22LeadTabs[Group>GroupName]EachGroupcanbeconfiguredbyselectingthedesiredtab.• Name:TheGroupcanberenamedhere(free‐formtextentry)• ForPatientUse:TheGroupwillbedisplayedonthePatientProgrammeronlyifthisboxischecked.NotethatthecurrentlyactiveGroupmustbechecked/enabled.• OnProgrammer/OnStimulator:ThesebuttonstoggletoallowtheusertovieweithertheProgrammervalues(possiblynotprogrammedyettotheStimulator)orthevaluesprogrammedontheStimulator• Lead1throughLead4:TheStimulusResponseforeachLeadwithinaGroupcanbechangedhere.StimulusResponsesthathavebeenpreviouslysavedforthatLeadwillbeshowninthedropdownmenu.• Response/Discard:UnwantedStimulusResponsedefinitionscanbediscardedhere.ThismaybeneededoncetheuserhasusedupthemaximumnumberofStimulusResponses(12).TheSpinalModulation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AUTHORIZED EUROPEAN REPRESENTATIVE MediTech Strategic Consultants B.V. Maastrichterlaan 127-129 6291 EN Vaals, Netherlands COMPANY 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
23GUIDANCE AND MANUFACTURER’S DECLARATION ElectromagneticEmissionsTheSpinalModulationNeurostimulatorSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulatorSystemshouldassurethatitisusedinsuchanenvironment.EmissionstestComplianceElectromagneticenvironment–guidanceRFEmissions1Group2TheSpinalModulationNeurostimulatorSystemmustemitelectromagneticenergyinordertoperformitsintendedfunction.Nearbyelectronicequipmentmaybeaffected.RFemissionsCISPR11ClassBHarmonicemissionsIEC61000‐3‐2ClassBVoltagefluctuations/flickeremissionsIEC61000‐3‐3CompliesTheSpinalModulationNeurostimulatorSystemissuitableforuseinallestablishments,includingdomesticestablishmentsandthosedirectlyconnectedtothepubliclowvoltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.CISPR14‐1CompliesTheClinicalProgrammerisnotintendedtobeconnectedtootherequipmentexcepttheModel3400ProgrammerCharger
24Guidanceandmanufacturer’sdeclarationElectromagneticImmunityTheSpinalModulationNeurostimulatorSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulatorSystemshouldassurethatitisusedinsuchanenvironment.ImmunityIEC60601TestLevelCompliance Level ElectromagneticenvironmentguidanceElectrostaticdischarge(ESD)IEC61000‐4‐2±6kVcontact±8kVairFloorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.Electricalfasttransient/burstIEC61000‐4‐4±2kVforpowersupplylines±1kVforinput/outputlinesPassMainspowerqualityshouldbethatofatypicalcommercialorhomeenvironmentSurgeIEC61000‐4‐5±1kVline(s)toline(s)±2kVline(s)toearthMainspowerqualityshouldbethatofatypicalcommercialorhomeenvironmentVoltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlinesIEC 61000-4-11 <5%UT(>95%dipinUT)for0,5cycle40%UT(60%dipinUT)for5cycles70%UT(30%dipinUT)for25cycles<5%UT(>95%dipinUT)for5sNOTE UT is the a.c. mains voltage prior to application of the test level.MainspowerqualityshouldbethatofatypicalcommercialorhomeenvironmentPowerfrequency(50/60Hz)magneticfieldIEC61000‐4‐83A/mPowerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercial,hospital,orhomeenvironment.
25Guidanceandmanufacturer’sdeclarationElectromagneticImmunityTheSpinalModulationNeurostimulationSystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulationSystemshouldassurethatitisusedinsuchanenvironmentImmunitytestIEC60601TESTLEVELCompliancelevelElectromagneticenvironmentguidanceConductedRFIEC61000‐4‐6RadiatedRFIEC61000‐4‐33Vrms150kHzto80MHz3V/m80MHzto2,5GHz3V3V/mPortableandmobileRFcommunicationsequipmentshouldbeusednoclosertoanypartofSpinalModulationNeurostimulationSystem,thantherecommendedseparationdistancecalculatedfromtheequationapplicabletothefrequencyofthetransmitter.Therecommendedseparationdistanceisaminimumof0.2meterfortransmittersof80MHzto2.5GHzInterferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.
26RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipmentandtheSpinalModulationNeurostimulationSystemTheSpinalModulationNeurostimulationSystemisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheSpinalModulationNeurostimulationSystemcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheSystemSeparationdistanceaccordingtofrequencyoftransmittermRatedmaximumoutputpoweroftransmitterW150kHzto80MHz80MHzto800MHz800MHzto2.5GHz0.010.12m0.12m0.23m0.10.37m0.37m0.74m11.17m1.17m2.33m103.70m3.70m7.37m10011.70m11.70m23.30mNOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.
27AppendixI:ProgrammableparametersandvaluesParameterProgrammableValuesDefaultPulseAmplitude0–6000µA0‐2000µA(25µAincrements)2000‐6000µA(50µAincrements)0µAMaximumPulseAmplitudeSameasPulseAmplitude0µAPulseWidth40–720µs(10µsincrements)40µsPulseFrequency4–100Hz(2Hzincrements)60Hz DataFieldSelectableValuesDiagnosis(PrimaryandSecondary)AbdominalPain;AxialLowBackPain;AxialNeckPain;CRPSType1;CRPSType2;DiabeticPeripheralNeuropathy;FBSS;FNSS;LowerExtremityNeuropathicPain;NeuropathicPain;Other;PeripheralNeuropathy;PhantomPain;Post‐HerpeticNeuralgia;PostSurgicalPain;RadicularArmPain;RadicularLegPain;ThoracicPain;UpperExtremityNeuropathicPain;VisceralPain;PeriodicImpedanceIntervalOff;30s;1min;5min;20min;30min;1h;12h;1days;10days;30daysLeadModelNumberMN0300;MN0400StimulusResponseAnatomy Off;Neck;Shoulder;Scapula;UpperBack;MiddleBack;LowerBack;Back&Leg;Thigh;Knee;LowerLeg;Ankle;Foot(top);Foot(bottom);Toes;Chest;Axila;Ribs;Abdomen;Hip;Groin;UpperArm;Elbow;Forearm;Hands;FingersStimulusResponseSensationOff;Burning;Buzzing;Cold;Comforting;Cramping;Heavy;Massaging;Numb;Other;Pain;Paresthesia;Pressure;Relief;Soothing;Spasm;Tapping;Tingling;Vibrating;WarmSpineLocationLL1;RL1;LL2;RL2;LL3;RL3;LL4;RL4;LL5;RL5;LT1;RT1;LT2;RT2;LT3;RT3;LT4;RT4;LT5;RT5;LT6;RT6;LT7;RT7;LT8;RT8;LT9;RT9;LT10;RT10;LT11;RT11;LT12;RT12;LS1;RS1;LS2;RS2;LS3;RS3;LS4;RS4;LS5;RS5;LC1;RC1;LC2;RC2;LC3;RC3;LC4;RC4;LC5;RC5;LC6;RC6;LC7;RC7;LC8;RC8MagnetTurnoffTimeOff;1s;2s;3s;4s;5s;6s;7s;8s;9s;10s;15s;20s;25s;30s;40s;50s;1min;70s;80s;90s;100s;110s;2minRampDuration0s;1s;2s;3s;4s;5s;6s;7s;8s
28AppendixII:INSBatteryLifeThefollowingfourtablesestimateINSbatterylifeunderthegivenloadimpedanceconditions.Tables1through4listestimatedlongevitybasedon1‐leadstimulation,active24hoursaday.Toestimatelongevityformultipleactiveleadsandtoaccountfordailyusage,usethefollowingformula:Where,C2 = Longevity for Lead 2 Settings Daily Usage Lead 2-353014And,DailyUsageLead1,2,3and4arefractionalvaluesequaltothenumberofhoursstimulationisenabledforeachleaddailydividedby24hours.Note:DonotentervaluesforC1,C2,C3orC4forcorrespondingleadsthatareinactive.Example:Estimatelongevityfor2leadstimulationwithlead1settingsof0.8mA,40Hz,200µsacross600ohmscontinuouslystimulating,andlead2settingsof1.0mA,60Hz,400µsacross1Kohmstimulatingfor16hoursperday.FromTable1(600ohms),longevityforlead1settings=58.9monthsFromTable2(1Kohm),longevityforlead2settings=34.1monthsCalculatedC1=(3014/58.9–35)*(24/24)=16.2CalculatedC2=(3014/34.1–35)*(16/24)=35.6Estimatedlongevityforthisexample=3014/(16.2+35.6+35)=34.7months
29Table1:LoadImpedance=600ohmsAlllongevityvaluesareinmonths PulsewidthAmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS4Hz83.983.883.683.483.283.082.882.782.620Hz81.580.980.179.278.377.576.775.975.840Hz78.677.676.074.573.071.670.268.968.660Hz76.074.672.470.368.366.564.763.162.780Hz73.571.869.166.664.262.160.058.157.80.1mA100Hz71.269.266.163.260.658.256.053.953.54Hz83.883.683.282.882.582.181.781.481.320Hz81.180.178.376.775.173.672.270.870.540Hz78.076.073.070.267.665.263.060.960.560Hz75.172.468.364.761.558.555.953.453.080Hz72.469.164.260.056.453.150.247.647.10.2mA100Hz69.866.160.656.052.048.645.642.942.44Hz83.783.282.581.781.080.379.678.978.820Hz80.478.375.172.269.466.964.662.461.940Hz76.773.067.663.058.955.452.249.448.960Hz73.368.361.555.951.247.243.840.940.480Hz70.164.256.450.245.241.237.834.934.40.4mA100Hz67.360.652.045.640.536.533.230.429.94Hz83.582.881.780.779.678.677.676.676.420Hz79.776.772.268.264.661.358.455.755.240Hz75.470.263.057.152.248.144.641.641.060Hz71.564.755.949.143.839.636.133.232.680Hz68.160.050.243.137.833.630.327.627.10.6mA100Hz64.956.045.638.433.229.226.123.623.14Hz83.482.581.079.678.276.975.774.474.220Hz79.075.169.464.660.356.653.350.449.840Hz74.267.658.952.246.942.538.935.935.360Hz69.961.551.243.838.334.130.727.927.480Hz66.156.445.237.832.428.425.322.822.30.8mA100Hz62.752.040.533.228.124.421.519.318.9
30Table1:LoadImpedance=600ohms(Continued)Alllongevityvaluesareinmonths  Pulsewidth  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS4Hz83.282.180.378.676.975.473.872.472.120Hz78.373.666.961.356.652.549.046.045.440Hz73.065.255.448.142.538.134.531.631.060Hz68.358.547.239.634.129.926.624.023.680Hz64.253.141.233.628.424.621.719.419.01.0mA100Hz60.648.636.529.224.420.918.316.315.94Hz82.881.278.676.173.871.769.667.767.320Hz76.770.161.354.549.044.640.837.737.140Hz70.259.948.140.234.530.326.924.323.860Hz64.752.339.631.926.622.920.117.917.580Hz60.046.433.626.421.718.416.014.213.81.5mA100Hz56.041.729.222.518.315.413.311.711.44Hz82.580.376.973.871.068.365.963.663.220Hz75.166.956.649.043.338.735.032.031.440Hz67.655.442.534.529.125.122.119.719.360Hz61.547.234.126.621.918.616.114.213.980Hz56.441.228.421.717.514.712.711.110.92.0mA100Hz52.036.524.418.314.612.210.59.28.94Hz56.653.849.746.243.140.538.136.035.620Hz46.338.229.624.120.417.615.513.913.640Hz37.728.019.615.112.310.38.97.87.760Hz31.822.114.711.08.87.36.35.55.380Hz27.518.311.78.66.85.64.84.24.14.0mA100Hz24.315.69.87.15.64.63.93.43.34Hz52.647.440.835.831.828.726.124.023.620Hz35.325.917.913.711.19.38.07.06.940Hz25.016.510.57.76.15.04.33.73.660Hz19.412.17.45.44.23.52.92.52.580Hz15.89.65.84.13.22.62.21.91.96.0mA100Hz13.37.94.73.32.62.11.81.61.5
31Table2:LoadImpedance=1KohmAlllongevityvaluesareinmonths PulsewidthAmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS4Hz83.983.883.683.483.283.082.882.782.620Hz81.580.980.179.278.377.576.775.975.840Hz78.677.676.074.573.071.670.268.968.660Hz76.074.672.470.368.366.564.763.162.780Hz73.571.869.166.664.262.160.058.157.80.1mA100Hz71.269.266.163.260.658.256.053.953.54Hz83.883.683.282.882.582.181.781.481.320Hz81.180.178.376.775.173.672.270.870.540Hz78.076.073.070.267.665.263.060.960.560Hz75.172.468.364.761.558.555.953.453.080Hz72.469.164.260.056.453.150.247.647.10.2mA100Hz69.866.160.656.052.048.645.642.942.44Hz83.783.282.581.781.080.379.678.978.820Hz80.478.375.172.269.466.964.662.461.940Hz76.773.067.663.058.955.452.249.448.960Hz73.368.361.555.951.247.243.840.940.480Hz70.164.256.450.245.241.237.834.934.40.4mA100Hz67.360.652.045.640.536.533.230.429.94Hz83.582.881.780.779.678.677.676.676.420Hz79.776.772.268.264.661.358.455.755.240Hz75.470.263.057.152.248.144.641.641.060Hz71.564.755.949.143.839.636.133.232.680Hz68.160.050.243.137.833.630.327.627.10.6mA100Hz64.956.045.638.433.229.226.123.623.14Hz83.482.581.079.678.276.975.774.474.220Hz79.075.169.464.660.356.653.350.449.840Hz74.267.658.952.246.942.538.935.935.360Hz69.961.551.243.838.334.130.727.927.480Hz66.156.445.237.832.428.425.322.822.30.8mA100Hz62.752.040.533.228.124.421.519.318.9
32Table2:LoadImpedance=1Kohm(Continued)Alllongevityvaluesareinmonths  Pulsewidth  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS4Hz83.282.180.378.676.975.473.872.472.120Hz78.373.666.961.356.652.549.046.045.440Hz73.065.255.448.142.538.134.531.631.060Hz68.358.547.239.634.129.926.624.023.680Hz64.253.141.233.628.424.621.719.419.01.0mA100Hz60.648.636.529.224.420.918.316.315.94Hz82.881.278.676.173.871.769.667.767.320Hz76.770.161.354.549.044.640.837.737.140Hz70.259.948.140.234.530.326.924.323.860Hz64.752.339.631.926.622.920.117.917.580Hz60.046.433.626.421.718.416.014.213.81.5mA100Hz56.041.729.222.518.315.413.311.711.44Hz58.457.255.153.351.549.948.346.946.620Hz53.148.241.836.933.029.827.325.124.740Hz47.740.332.126.622.819.917.615.915.560Hz43.234.626.020.817.414.913.011.611.380Hz39.630.421.917.114.011.910.39.18.92.0mA100Hz36.527.018.914.511.89.98.67.57.44Hz53.049.143.639.235.732.730.228.027.620Hz36.328.420.916.513.611.610.19.08.840Hz26.118.612.69.67.76.45.54.84.760Hz20.313.99.16.75.34.43.83.33.280Hz16.711.07.15.24.13.42.92.52.54.0mA100Hz14.19.25.84.23.32.72.32.02.04Hz51.446.540.235.431.628.626.124.023.620Hz32.724.517.413.410.99.28.07.06.940Hz22.415.410.17.66.05.04.33.73.760Hz17.111.37.25.34.23.42.92.52.580Hz13.88.95.54.03.22.62.21.91.96.0mA100Hz11.67.34.53.32.62.11.81.61.5
33Table3:LoadImpedance=1.5KohmAlllongevityvaluesareinmonths PulsewidthAmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS4Hz83.983.883.683.483.283.082.882.782.620Hz81.580.980.179.278.377.576.775.975.840Hz78.677.676.074.573.071.670.268.968.660Hz76.074.672.470.368.366.564.763.162.780Hz73.571.869.166.664.262.160.058.157.80.1mA100Hz71.269.266.163.260.658.256.053.953.54Hz83.883.683.282.882.582.181.781.481.320Hz81.180.178.376.775.173.672.270.870.540Hz78.076.073.070.267.665.263.060.960.560Hz75.172.468.364.761.558.555.953.453.080Hz72.469.164.260.056.453.150.247.647.10.2mA100Hz69.866.160.656.052.048.645.642.942.44Hz83.783.282.581.781.080.379.678.978.820Hz80.478.375.172.269.466.964.662.461.940Hz76.773.067.663.058.955.452.249.448.960Hz73.368.361.555.951.247.243.840.940.480Hz70.164.256.450.245.241.237.834.934.40.4mA100Hz67.360.652.045.640.536.533.230.429.94Hz83.582.881.780.779.678.677.676.676.420Hz79.776.772.268.264.661.358.455.755.240Hz75.470.263.057.152.248.144.641.641.060Hz71.564.755.949.143.839.636.133.232.680Hz68.160.050.243.137.833.630.327.627.10.6mA100Hz64.956.045.638.433.229.226.123.623.14Hz83.482.581.079.678.276.975.774.474.220Hz79.075.169.464.660.356.653.350.449.840Hz74.267.658.952.246.942.538.935.935.360Hz69.961.551.243.838.334.130.727.927.480Hz66.156.445.237.832.428.425.322.822.30.8mA100Hz62.752.040.533.228.124.421.519.318.9
34Table3:LoadImpedance=1.5Kohm(Continued)Alllongevityvaluesareinmonths  Pulsewidth  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS4Hz83.282.180.378.676.975.473.872.472.120Hz78.373.666.961.356.652.549.046.045.440Hz73.065.255.448.142.538.134.531.631.060Hz68.358.547.239.634.129.926.624.023.680Hz64.253.141.233.628.424.621.719.419.01.0mA100Hz60.648.636.529.224.420.918.316.315.94Hz58.257.155.453.852.350.849.548.247.920Hz52.047.942.538.134.631.629.127.026.640Hz45.940.032.927.924.321.519.317.417.160Hz41.134.226.822.118.716.314.412.912.680Hz37.230.022.718.215.213.111.510.210.01.5mA100Hz33.926.619.615.512.810.99.58.58.34Hz56.454.651.949.547.245.243.341.641.320Hz45.740.433.829.125.622.820.518.718.440Hz36.930.423.619.216.214.112.411.110.960Hz30.924.418.114.411.910.28.97.97.780Hz26.620.414.711.59.48.06.96.16.02.0mA100Hz23.417.512.39.57.86.55.75.04.94Hz52.649.144.240.236.934.131.629.529.120Hz35.328.521.617.414.512.510.99.79.540Hz25.018.713.210.18.37.06.05.35.260Hz19.313.99.57.25.84.84.23.63.680Hz15.811.17.45.54.43.73.22.82.74.0mA100Hz13.39.26.14.53.63.02.62.22.24Hz52.649.144.240.236.934.131.629.529.120Hz35.328.521.617.414.512.510.99.79.540Hz25.018.713.210.18.37.06.05.35.260Hz19.313.99.57.25.84.84.23.63.680Hz15.811.17.45.54.43.73.22.82.76.0mA100Hz13.39.26.14.53.63.02.62.22.2
35Table4:LoadImpedance=2KohmAlllongevityvaluesareinmonths PulsewidthAmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS4Hz83.983.883.683.483.283.082.882.782.620Hz81.580.980.179.278.377.576.775.975.840Hz78.677.676.074.573.071.670.268.968.660Hz76.074.672.470.368.366.564.763.162.780Hz73.571.869.166.664.262.160.058.157.80.1mA100Hz71.269.266.163.260.658.256.053.953.54Hz83.883.683.282.882.582.181.781.481.320Hz81.180.178.376.775.173.672.270.870.540Hz78.076.073.070.267.665.263.060.960.560Hz75.172.468.364.761.558.555.953.453.080Hz72.469.164.260.056.453.150.247.647.10.2mA100Hz69.866.160.656.052.048.645.642.942.44Hz83.783.282.581.781.080.379.678.978.820Hz80.478.375.172.269.466.964.662.461.940Hz76.773.067.663.058.955.452.249.448.960Hz73.368.361.555.951.247.243.840.940.480Hz70.164.256.450.245.241.237.834.934.40.4mA100Hz67.360.652.045.640.536.533.230.429.94Hz83.582.881.780.779.678.677.676.676.420Hz79.776.772.268.264.661.358.455.755.240Hz75.470.263.057.152.248.144.641.641.060Hz71.564.755.949.143.839.636.133.232.680Hz68.160.050.243.137.833.630.327.627.10.6mA100Hz64.956.045.638.433.229.226.123.623.14Hz83.482.581.079.678.276.975.774.474.220Hz79.075.169.464.660.356.653.350.449.840Hz74.267.658.952.246.942.538.935.935.360Hz69.961.551.243.838.334.130.727.927.480Hz66.156.445.237.832.428.425.322.822.30.8mA100Hz62.752.040.533.228.124.421.519.318.9
36Table4:LoadImpedance=2Kohm(Continued)Alllongevityvaluesareinmonths  Pulsewidth  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS4Hz58.958.257.256.155.154.253.352.452.220Hz55.052.248.244.841.839.236.934.834.440Hz50.746.340.335.732.129.126.624.524.260Hz47.141.534.629.726.023.120.818.918.680Hz44.037.730.425.421.919.217.115.415.11.0mA100Hz41.234.527.022.218.916.414.513.012.74Hz56.755.453.251.349.547.846.244.744.420Hz46.742.436.832.529.126.424.122.221.840Hz38.232.826.622.319.216.915.113.613.360Hz32.426.820.817.014.412.411.09.89.680Hz28.122.617.113.711.59.88.67.77.51.5mA100Hz24.819.614.511.59.58.17.16.36.24Hz54.552.349.146.243.641.339.239.237.020Hz40.134.728.424.120.918.416.516.514.640Hz30.124.518.615.112.610.99.69.68.360Hz24.118.913.911.09.17.76.76.75.880Hz20.115.411.08.67.16.05.25.24.52.0mA100Hz17.213.09.27.15.84.94.24.23.64Hz53.250.546.543.140.237.735.433.433.020Hz36.731.024.520.317.415.113.412.111.840Hz26.520.915.412.210.18.77.66.76.660Hz20.715.711.38.87.26.15.34.64.580Hz17.012.68.96.85.54.74.03.63.54.0mA100Hz14.410.67.35.64.53.83.32.92.84Hz53.250.546.543.140.237.735.433.433.020Hz36.731.024.520.317.415.113.412.111.840Hz26.520.915.412.210.18.77.66.76.660Hz20.715.711.38.87.26.15.34.64.580Hz17.012.68.96.85.54.74.03.63.56.0mA100Hz14.410.67.35.64.53.83.32.92.8
37AppendixIII:TroubleshootingPop‐upMessagesConditionButtonsResolutionAllstimulationhasbeenturnedOFF. AllstimulationturnedoffduetodatacorruptionorDevicebeinginHibernatemode.“OK”ContactyourSpinalModulationRepresentative.CancelledConnectRequestCancelwaspressedwithconnectingattemptinprogress. Changessincelastprogrammingwerelostduetolossofconnectionwiththestimulator.Pleasereconnecttostimulator.Communicationwaslostpriortoprogrammingattempt.“OK”Reconnecttostimulatorandre‐enterprogramchanges.Connectedtostimulator.Communicationispoor.AllRFchannelshavenoiselevelsabovethenoisethreshold. Trymovingtoanareawithfewersourcesofnoise.Connectingtostimulator...“Connect”buttononthemainmenuwaspressed. ConnectionEstablished.Connectionattemptwassuccessful.“OK”Connectionwithstimulatorwaslost.Pleasereconnect.DroppedRFconnection."Yes""No""Cancel"Doyouwanttoprogramchanges?AnewWorkspaceorExitbuttonwasselectedwithoutsaving(programming)changes.“OK”InvalidFCEpassword.Pleasetryagain.InvalidFCEpasswordwasentered.“OK”OnlySpinalModulationrepresentativesshouldaccesstheFCEmode.LeadNdetectedaCurrentTooHighcondition.Duringanimpedancemeasurement,themeasuredcurrentwastoohigh.“OK”Repeatmeasurement.Ifproblemreoccurs,contactyourSpinalModulationrepresentative.LeadNimpedanceofNNNΩisoutofrange.Leadimpedanceisoutofrange“OK”Repeatmeasurementoracceptasis.Maximumstimulationoutputhasbeenreached.Maximumstimulationoutputhasbeenreached(5.2V).“OK”Investigateleadintegrity.PleasespecifyaStimulusResponsebeforeprogrammingAttempttoprogramasetofpulseparameterswithoutaStimulusResponseName.“OK”Selectstimulusresponse.Programmerbatteryislow.Pleaserecharge.PDAbatteryreaches30%.“OK”Rechargeassoonaspossible.Programmerisbootingafterareset.WhenyouclickOKtheProgrammerwillswitchoff.PressthePowerbuttontorestart.HardwareresetButtononthePDAwaspressedortheProgrammerislaunchedforthefirsttime.PressPowerbutton.Programmerstoragespaceisfull.Filelogginghasstopped.PleasecontactyourSpinalModulationrepresentativeformaintenance.PDAstorageisfull.Afteruseracknowledgement,normaloperationcontinues.“OK”ContactyourSpinalModulationRepresentative.Pop‐upMessages(Cont.)ConditionButtonsResolution
38Programmerstoragespaceislow.PleasecontactyourSpinalModulationrepresentativeformaintenance.PDAstorageisnearingfullcapacity(logfilesarestoredonthePDAwitheachsignificantoperationsuchasprogramming).Messageisdisplayedandfileloggingshouldcontinue.Normaloperationcontinuesafteruseracknowledgement.“OK”ContactyourSpinalModulationRepresentative.StimulationforoneormoreleadshasbeenturnedOFF.OneormoreleadsturnedoffduetoLowImpedance.“OK”Performimpedancemeasurementandre‐enableifwithinrange.Otherwise,investigateleadintegrity.StimulationhasbeenturnedOFFduetoamagnet.StimulationcanbeturnedoffbyapplyingamagnetforthedurationspecifiedbytheMagnetTurnoffTimeprogrammableparameter.“OK”StimulationhasbeenturnedOFF.Stimulationcanbeturnedoff,eitherbythe“AllStimOFF”softwarebuttonontheINSprogrammer,ortheOffswitchontheTNS.“OK”StimulatorbatteryhasreachedEndofService(EOS).StimulationhasbeenturnedOFFpermanently.BatteryhasreachedEOSvoltage.StimulationisdisabledinordertopreservepowerforRFcommunication.“OK”SchedulereplacementoftheStimulator.StimulatorbatteryhasreachedtheElectiveReplacementIndicator(ERI).BatteryhasreachedERIvoltage. “OK”SchedulereplacementoftheStimulator.StimulatorclockisHH:MM.DoyouwanttoupdateStimulatorclock?TheNSinternaltimeisoutofsyncwiththeProgrammertime.“Yes”“No”Thestimulatorhasbeensettodefaultvalues.TheProgrammerhasencounteredanNSwithunreadableorinvaliddata.Parametershavebeensetandprogrammedtodefaultvalues.“OK”Setupdeviceparametersasdesired.Thestimulatorhasunreadabledata.PleasereconnectwithprogrammerinFCEmodeorcontactyourSpinalModulationrepresentativeNShasunreadabledata(suchasTrimdata)“OK”ContactyourSpinalModulationRepresentative.ThestimulatorisinUpgradeMode.PleasereconnectwithprogrammerinFCEmodeorcontactyourSpinalModulationrepresentative.NSinBootmode.“OK”ContactyourSpinalModulationRepresentative.Unabletoconnecttostimulator.Makesuretheprogrammerisclosetothestimulatorandtryagain.Can’tconnecttotheNS.“OK”MovetheprogrammerabovetheStimulatorincircularmotions.Errormessagesmaycontainadditionaltroubleshootinginformationsuchas“ErrorCode:04‐123,BadParameterValue”.ThisisanaidforSpinalModulationengineerstodebugerrors.

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