Spinal Modulation orporated MN0700 Clinical Programmer User Manual LP0015 Rev Draft FCC PProg

Spinal Modulation, Incorporated Clinical Programmer LP0015 Rev Draft FCC PProg

Contents

Revised user manual MN-0600

PatientProgrammerModelMN0600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. LP0015 Rev E, June 2011
SPINAL MODULATION, INC. PATIENT PROGRAMMER USER MANUAL 2 TABLEOFCONTENTSEXPLANATIONOFSYMBOLSONPRODUCTORPACKAGELABELING....................................................................... 3GLOSSARY .............................................................................................................................................. 4INTRODUCTION........................................................................................................................................ 5INDICATIONSFORUSE ............................................................................................................................... 5DESCRIPTION........................................................................................................................................... 5WARNING .............................................................................................................................................. 5PRECAUTIONS–FORYOURPATIENTPROGRAMMERANDYOURSTIMULATORDEVICE............................................. 6PRECAUTIONS–FORYOURTHERAPY............................................................................................................ 7PATIENTPROGRAMMERFEATURES ............................................................................................................ 10CHARGINGTHEBATTERY.......................................................................................................................... 10PROGRAMMERPOWERUP....................................................................................................................... 10MAINMENU......................................................................................................................................... 12CONNECTINGTOYOURSTIMULATORDEVICE................................................................................................ 13PAINCONTROLSCREEN ........................................................................................................................... 15BACKTOMAINMENU ........................................................................................................................ 15SELECTGROUP .................................................................................................................................. 15PROGRAMMERSTATUSBAR ................................................................................................................. 16ADJUSTINGYOURSTIMULATORDEVICESETTINGS ......................................................................................... 16TURNINGOFFSTIMULATION ................................................................................................................. 16PAINCONTROLTAB............................................................................................................................ 17ADJUSTSTIMULATIONLEVELFORABODYREGION .......................................................................................17INFOTAB ......................................................................................................................................... 18DEVICETABANDPHYSICIANTAB ...............................................................................................................18CLINICTAB ............................................................................................................................................ 18USINGYOURTNSDEVICE.................................................................................................................... 19USINGYOURINSDEVICE......................................................................................................................... 19AUTHORIZEDEUROPEANREPRESENTATIVE .................................................................................................. 19COMPANYCONTACTINFORMATION ........................................................................................................... 19GUIDANCEANDMANUFACTURER’SDECLARATION.......................................................................................... 20ELECTROMAGNETICEMISSIONS............................................................................................................... 20ELECTROMAGNETICIMMUNITY .............................................................................................................. 21APPENDIXI:INSBATTERYLIFE ................................................................................................................. 23APPENDIXII:TROUBLESHOOTING .............................................................................................................. 32
3 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
4 Glossary Lead–Surgicalwire:takeselectricalsignalsfromtheneurostimulatortothestimulationarea.Stimulation–Smallelectricalpulses:producesatinglingsensationandreplacespainsignals.Stimulator–Devicethatmakeselectricalpulsesthatstimulatethenervesinyourspine:definedasTrialNeurostimulatororImplantableNeurostimulator.TrialNeurostimulator(TNS)‐Externalstimulatordevicethatclipsontoyourbelt:attachestotheconnectorcableandwhichisconnectedtoleadsimplantedintheareanearyourspine.ImplantableNeurostimulator(INS)‐Stimulatordeviceimplantedinyourbackorabdomen:attachestoleadsimplantedintheareanearyourspine.ConnectorCable–Cablethatconnectstheleadstoyourtrialstimulatordevice.PatientProgrammer–Portable,hand‐helddevice:allowsyoutoadjustthestimulationsettings.ClinicalProgrammer–Portable,hand‐helddevice:allowsthecliniciantoprogramthestimulatordevice.ComputerTomography(CT)Imaging–ComputerizedX‐rayimaging:produceselectronicimagesoftissuesandorgans.Diathermy–Highenergyheat:usedtocutorcauterizeduringsurgeryoratypeoftherapy.ElectromagneticInterference(EMI)–Electricalsignalsthatinterferewiththedevicefunction.MagneticResonanceImaging(MRI)–Medicalimaging:produceselectronicimagesoftissuesandorgans.Paresthesia–Tinglingsensationfeltduringtherapydelivery:producedbyspinalcordstimulation.Precaution–SituationthatcouldcauseuncomfortablestimulationandpossibledamagetothestimulatordeviceorPatientProgrammer.Program–InstructionsorchangestostimulationsettingsthatareprogrammedintothePatientProgrammerandtransmittedtothestimulatordevice.StimulationLevel–Measureofstimulation:canbeincreasedordecreasedwithinarangespecifiedbyyourdoctor.Warning–Potentiallyserioushazardthatcouldcauseinjuryordeath.
5 INTRODUCTIONYourPatientProgrammerisusedtoprogramyourstimulatordevice,ifrequired.ThisUserManualgivesdetailedinstructionsonhowtosafelyuseyourPatientProgrammerandyourstimulatordevice.ItalsoinstructsyouonhowtorechargeyourPatientProgrammer.Seeyourdoctorifyouhaveanyquestions.INDICATIONSFORUSETheSpinalModulationNeurostimulatorSystemwasdesignedtobeusedtomanageprolongedpainasstatedinthefollowingindicationstatement:TheSpinalModulationneurostimulation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TheClinicalandPatientProgrammersareusedtoconnecttothestimulatordevice.– TheClinicalProgrammercontrolsthestimulatordevice.Onlyyourdoctorand/orSpinalModulationclinicalpersonnelmayusetheClinicalProgrammer.– ThePatientProgrammerallowsyoutoadjustthesettingsofthestimulatordevice.Yourdoctorspecifiestherangeofsettings.ItalsoallowsyoutoturnOFFallstimulation,ifrequired.ThePatientProgrammerisaportable,handhelddevice.Itisdesignedtobeeasytouse.Itcanbepluggedintoapoweroutletorpoweredbyaninternal,rechargeablebattery.ThePatientProgrammerusesaninternalmagnettoconnecttothestimulatordevice.Thisallowsthepatienttocontrolstimulationsettings.WARNING• DonotuseyourPatientProgrammerorthestimulatordeviceuntilyourdoctorhastrainedyou.• DonotuseyourPatientProgrammeruntilyourdoctorhassetupyourstimulatordevice.• Donotundergoanyelectivemagneticresonanceimaging(MRI)procedure.IfMRIisnecessary,yourphysicianmustremoveanylead(s).YourdoctormustalsodisconnecttheTNSorINSdevice.UseofMRIintheareaofthelead(s)maydislodgethelead(s)ordamagetheTNSorINS.Ifavoltageisinducedthroughthelead,itmaycauseuncomfortable(“jolting”or“shocking”)levelsofstimulation.• Donotundergoanydiathermy(highenergyheat)procedures.Diathermymaycausebodilyinjuryordamagetothestimulatordevice.• Donotremovethelead(s)orConnectorCableduringthetrialperiod.Aninfectionmayresult.• Changesinbodypositioncanincreasepainorcauseuncomfortablestimulation.UsethePatientProgrammertoadjuststimulationlevelsortoturnOFFstimulation,ifrequired.
6 Warnings(continued)• Strongelectromagneticfieldsmayinterferewiththestimulatordevice.Thisinterferencecanaffectthestimulationlevelandcausediscomfort.Avoidtheftdetectiondevicesatstoreandlibraryexits.Alsoavoidairportsecurityscreeners.Donotstandnearthescreeningequipment.• Otherequipmentthatmaycauseinterferenceincludesbutisnotlimitedto:powergenerators,arcweldersandlargemagnetizedspeakers.Donotstandnearthesedevices.• DonotleaveyourProgrammerChargerwherepets,childrenoryoumaybecomeentangledinthecord,causingafallorstrangulation.• Reportarashduetosystemcomponentstoyourdoctor.Ifyourthroatortonguestartstoswellgetemergencyaidimmediately.PRECAUTIONS–FORYOURPATIENTPROGRAMMERANDYOURSTIMULATORDEVICEFollowtheseprecautionstoavoiddamagetoandassureproperfunctionofyourPatientProgrammerandstimulatordevice.• DonotdropormishandleyourPatientProgrammerorstimulatordevice.Physicaldamagetothedevicesmayimpairtheirfunction.• DonotwashthePatientProgrammerorTNSdevicewithexcessivewater.Donotgeteitherdevicewet.Excessivemoisturemayimpairtheirfunction.Ifcleaningisnecessary,removesoilwithasoftdampcloth.• DonotshowerorbathewiththeTNSdevice.(YoumaytakeaspongebathiftheTNSdevicedoesnotgetwet.)• AvoidcontactwithbodyfluidsfortheTNSandPatientProgrammer.Contaminationmaycausedamagetothedevices.• DonotuseabrasiveorcausticcleaningproductsonyourPatientProgrammerorTNSdevice.• DonotuseanyequipmentoraccessoriesthatarenotsuppliedwithyourPatientProgrammer.Donotpluganythingintotheconnectoratthebottomoftheprogrammer.ItisforClinicuseonly.• DonotopenthecasesofthePatientProgrammerorTNSdeviceormodifytheminanyway.Thismayexposethedevicestoelementsthataltertheirfunction.• DonotplaceyourPatientProgrammerclosetocreditcardsorothercardswithmagneticstrips.ThePatientProgrammermagnetmaydemagnetizeyourcards.KeepthePatientProgrammerawayfromcomputerharddrivesandmagneticstoragedevices.• DonotoperatethePatientProgrammerorstimulatordeviceoutsidethetemperaturerangeof‐5°Cto45°C(23°Fto113°F).Rapidtemperaturechangesmayaffectproperdeviceoperation.• DonotstorethePatientProgrammeroutsidethetemperaturerangeof‐10°Cto50°C(14°Fto122°F).• DonotleavethePatientProgrammerinacarorotherplaceswheretemperaturescanexceed50°C(122°F).
7 DevicePrecautions(continued)• Failureofyourstimulatorsystem,althoughunlikely,ispossibleduetorandomcomponentfailure.Ifanypartofyourstimulatorsystemstopsworkingoryouseeachangeinhowitworks,discontinueuseandcontactyourdoctorduringnormalbusinesshours.• ReturnyourPatientProgrammerandTNSdevicetoyourdoctorattheendofthetrialperiod.DonotdiscardorburnthePatientProgrammerorTNSdevice.Firemaycausetheinternalbatteriestoexplode.• DonottrytoreplacetheTNSdevicebattery,eveniftheTNSdevicedoesnotfunction.OnlySpinalModulationpersonnelmayreplacetheTNSdevicebattery.• Donotuseanyothercompany’sdevicetoprogramyourstimulatordevice.UseonlythePatientProgrammerprovidedbySpinalModulation.• DonotallowunauthorizeduseofyourPatientProgrammer.Thismaycauseunwantedprogrammingchanges.• DonotusethePatientProgrammerorstimulatordevicenearexplosiveorflammablegases.Seriousinjurymayoccur.• DonotusetheProgrammerChargerifthepowercordisdamaged,excessivelywornorfrayed.Thismaycauseinjuryordamageyourstimulationdevice.• ToremovepowerfromtheProgrammerChargerwhennotinuse,unplugfromthewall.• Frequentprogrammingofyourimplanteddevicewillcausethebatterytodepletefaster.Avoidunnecessaryprogramming.PRECAUTIONS–FORYOURTHERAPYFollowtheseprecautionstomaintainappropriatetherapy:• Followproperwoundcaretechniques,asinstructedbyyourdoctor.• Donotruborpressontheimplantsite.Thismaycausetheleadstodislodgeoryourskintoerode.ItmayalsocauseinversionoftheINS.• Avoidexcessivebending,twistingandstretching.Donotliftobjectsovertenpounds.Theseactivitiesmaycausetheleadstomove.Understimulationoroverstimulationmayresult.• AvoiddrivingacaroroperatingotherpotentiallydangerousmachinerywhilestimulationisON.Youcouldbedistractedfromvehicleordeviceoperationifsuddenchangesinstimulationweretooccur.• Yourstimulatordevicemayaffecttheoperationofotherimplantabledevices,suchaspacemakersorimplantablecardiacdefibrillators.Tellyourdoctoraboutanyotherimplantabledevicesthatyouhaveorarescheduledtoget.
8 TherapyPrecautions(continued)• Tellyourregulardoctor(s)orhealthcareprovidersthatyouhaveastimulatordevice.Donotundergoanyelectivemedicalprocedureswithoutfirstdiscussingthemwithyourphysician.Somemedicaldevicesortherapies,suchasthoselistedbelow,mayinterferewithyourstimulatordevice:o Electrocautery–Electricprobetocauterizebloodvesselsandstopbleedingduringsurgery.o Lithotripsy–Shockwavestobreakupgallstonesandkidneystones.o TherapeuticRadiation–Usedtodestroycancercells.o High‐outputultrasound–Soundwavestotreatboneandmuscleinjuries,ortostimulatemuscleorimprovebloodflow.o RFAblation–Radiofrequencyenergytocausecontrolledtissuedamage.o MicrowaveAblation–Alternatingelectricfieldtocausecontrolledtissuedamage.o Dentalprocedures,electrolysis,staticfieldtherapeuticmagnetsanddiagnosticX‐ray.• Appointafamilymemberorfriendtotellemergencymedicalpersonnelthatyouhaveastimulatordevice,incaseyouneedemergencycare.YouwillbegivenaMedicalAlertCardtocarrywithyou.Thiscardwillinformemergencymedicalpersonnelthatyouhaveastimulatordevice.Ifyouhaveanyconcernsaboutyourstimulatordevice,contactyourdoctorduringnormalbusinesshours.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..
9 PATIENTPROGRAMMEROVERVIEWYourPatientProgrammerisaportable,handhelddevice.Itispoweredbyaninternal,rechargeablebattery.Itcanalsobepluggedintoapoweroutlet.YourPatientProgrammerworkswithyourstimulatordevicetocontrolstimulation.YourdoctorwillexplainhowtousethePatientProgrammertoadjuststimulationforoptimalpainrelief.KeepyourPatientProgrammernearyouatalltimes.Thisallowsyoutoadjuststimulation,ifnecessary.CarryyourPatientProgrammerinthecaseprovidedasthecaseprovidesprotectionfromwater.YourPatientProgrammersystemconsistsof:• PatientProgrammerwithStylus(andinternalmagnet)MN0600• AuxiliaryMagnetMN3300• ProgrammerChargerMN3400Input:100‐240VAC,50‐60Hz,0.6AOutput:5V 3.0A• CarryingCaseMN3500• PatientProgrammerUserManual(thisdocument)• PatientInformationSheet• PatientMedicalAlertCardPatientProgrammer Programmer Charger Programmer Power Stylus •Battery Status Bar •AC – Battery Charging •100% – Battery Charge Complete
10 PATIENTPROGRAMMERFEATURESWithyourPatientProgrammer,youcan:• TurnOFFallstimulation,ifrequired.• TurnstimulationONorOFFforeachbodyregion.• Adjustthestimulationlevelforeachbodyregion.• ChangetheGroupforstimulation.See“SelectGroup”underthe“PainControlScreen”section.• ViewyourstimulatordeviceIDinformation.• ViewyournameoryourIDnumber.• Viewyourleadimplantdate.• Viewyourphysicianname,clinicnameandcontactinformation.CHARGINGTHEBATTERYYouwillneedtheProgrammerChargerprovidedtochargethePatientProgrammerbattery.Chargingthebatterytakesapproximately2–4hoursforafullcharge.TheProgrammerStatusBaratthebottomofthescreenshowsthebatterychargelevel.1. ConnecttheProgrammerChargertoapoweroutlet.2. ConnecttheChargertoyourPatientProgrammer.Whenthebatteryischarging,thebatteryicononthescreenshows“AC”.Whenchargingiscomplete,100%showsnexttothebatteryicon.YourPatientProgrammerwilloperatenormallyanddoesnotusebatterypowerwhenitisconnectedtoapoweroutlet.ConnectyourPatientProgrammertotheChargerandattachtoanoutletregularlytokeepitcharged.YourPatientProgrammerandProgrammerChargerhaveanexpectedserviceperiodofuptothreeyears.Improperchargingmayreducethisperiod.PROGRAMMERPOWERUPPressthe“”buttontoturnONyourPatientProgrammerscreen.TheMainMenuwilldisplay. Press here to turn on Programmer Screen
11 NOTE:IfthePatientProgrammerdoesnotturnON,chargethebattery,andtryagain.
12 MAINMENUTheProgrammerMainMenudisplaystwomainfunctions:• Connect:Allowsyoutoconnecttoyourstimulatordevice;alsoallowsyoutoadjuststimulationsettings.• ProgrammerSetup:AllowsyoutosetyourPatientProgrammerdateandtime;alsoallowsyoutoviewinformationaboutyourstimulatordevice.TheMainMenuidentifiesthedeviceasyourSpinalModulationPatientProgrammer.Yourphysician,clinicandtheclinicphonenumberarealsoshown.TheProgrammerstatusbarislocatedatthebottomoftheMainMenu.ThestatusbarshowstheProgrammer–stimulatorconnectionstatus.Italsoshowsthebatterychargelevelandthetime.Seethe“ProgrammerStatusBar”sectioninthisUserManualformoredetail.YoucanchangethetimeanddateandaccesstheProgrammerInfoscreenfromtheProgrammerSetupscreen.YoucanalsoviewyourstimulatordeviceserialnumberandyournameorpatientID.TheProgrammerInfoscreenshowsyourprogrammerserialnumber,softwareversionandmanufacturingdate.Italsoshowsthebasestationfirmwareversion. 
13 StimulatorDeviceBindingYourdoctorwillbindyourstimulatordevicetoyourPatientProgrammer.Youcannoteditthisinformation.ConnectPressthe“Connect”buttonontheMainMenutoconnecttoyourstimulatordevice.Onceconnected,youcanadjuststimulationsettings.Seethe“ConnectingtoYourStimulatorDevice”sectionbelowformoredetail.MagnetAmagnetislocatedunderthemagnetsymbolonthebacksideofthePatientProgrammer.PlacethemagnetoverthestimulatordevicetocheckforconnectionbetweenthePatientProgrammerandstimulatordevice.Seethe“ConnectingtoYourStimulatorDevice”sectionbelowformoredetail.ConnectingtoYourStimulatorDeviceUseyourPatientProgrammertoconnecttoyourstimulatordevice.• MakesurethatyourPatientProgrammeristurnedONandthattheMainMenudisplays.YourPatientProgrammermustbewithin6feetofyourstimulatordevice.• Pressthe“Connect”button.ThePatientProgrammerwillbeginsearchingforthestimulatordevice.Aniconshowsonthescreentoindicatethatitisbusy.• PositionthemagnetonthePatientProgrammeroveryourstimulatordeviceandmovearoundinacircularmotiontoinitiatecommunication.ThePatientProgrammerchimeswhenitisconnectedtoyourstimulatordevice.ThePainControlscreendisplays.“Connected”showsinthestatusbaratthebottomleftofthescreen.IfyourPatientProgrammercannotconnecttoyourstimulatordevice,anerrormessagedisplays.“Disconnected”showsinthestatusbar.IfyourPatientProgrammercannotconnecttoyourstimulatordevice,gobacktotheMainMenu.Press“Connect”again.Movethemagnetinacircularfashionoveryourstimulatordevice.RepeatuntilthePatientProgrammerconnectstothestimulatordevice.NOTE:Ifafter2minutesyourPatientProgrammercannotconnecttothestimulatordevice,placethePatientProgrammeroverthestimulatordeviceagain.Anerrormessagemaydisplay.ThemessageasksyouMagnet
14 toconfirmthatyourPatientProgrammerisnearenoughtothestimulatordevice.AfterconfirmingthatyourPatientProgrammeriswithin6feetofthestimulatordevice,press“OK”.Press“Connect”again.
15 PAINCONTROLSCREENAtthetopofthePainControlscreen.TheIDHeadingshowsyournameorIDnumberandyourstimulatordevice’sserialnumber.The“TurnAllStimulationOFF”buttonisbelowtheIDHeading.Twotabsarebelowthe“TurnAllStimulationOFF”button:the“PainControl”tabandthe“Info”(Information)tab.Seethe“AdjustingYourStimulatorDeviceSettings”sectioninthisUserManualformoredetail.The“Exit”buttonatthebottomrightsideofthescreenreturnsyoutotheMainMenu.IDHeading,locatedatthetopofthescreen,showsthefollowinginformation:• YourIdentification(ID)Number• YourStimulatorDeviceSerialNumberBACKTOMAINMENUThe“Exit”buttonclosesthePainControlwindow,endsthesession,andreturnstotheMainMenu.NOTE:Whenprogrammingiscomplete,selectthe“Exit”buttonandpowerofftheprogrammertoconservepower.SELECTGROUPThe“SelectGroup”buttonislocatedinthecenterofthePainControlscreen.Press“SelectGroup”todisplayadropdownmenu.Thedropdownmenuhasuptofourgroupsdefinedbyyourdoctor.Whenyouselectagroupname,thestimulatordeviceswitchessettingstothenewgroup.
16 PROGRAMMERSTATUSBARTheProgrammerStatusBarislocatedatthebottomofthePatientProgrammerscreen.ThestatusbarshowstheProgrammer‐stimulatorconnectionstatus,thebatterychargelevelandthetime.• Programmer‐StimulatorConnectionStatus:Shows“Connecting”whenthePatientProgrammeristryingtoconnecttothestimulatordevice;shows“Connected”whenthePatientProgrammerisconnectedtothestimulatordevice;andshows“Disconnected”whenthePatientProgrammerisdisconnectedfromthestimulatordevice.• ProgrammerBatteryLevel:ShowsthePatientProgrammerbatterychargelevel.• ProgrammerClock:Showsthetime.Seethe“MainMenu”sectioninthisUserManualformoredetail.ADJUSTINGYOURSTIMULATORDEVICESETTINGSYoucanadjustyourstimulatordevicesettingsfromthePainControlscreen.StimulationcanbeturnedONorOFFforuptofourregionsofyourbody.Youcanalsoadjustthestimulationlevelforanyofthoseregions.TURNINGOFFSTIMULATION• Pressthe“TurnAllStimulationOFF”buttontostopallstimulationtherapy.Aconfirmationwindowappears,askingdoyouwanttoturnOFFallstimulation.NOTE:AfterturningOFFallstimulation,youcanrestorestimulationtherapyforeachofthebodyregionsindividually.Seethe“TurnStimulationONorOFFforaBodyRegion”sectionbelow.
17 PAINCONTROLTABSelectthe“PainControl”tablocatedatthetopofthePainControlscreen.Fromthe“PainControl”tab,youcanturnstimulationONorOFFforeachbodyregion.Youcanalsoadjustthestimulationlevelforeachbodyregion.TURNSTIMULATIONONOROFFFORABODYREGIONYourPatientProgrammershowsthenamesofonetofourbodyregionsinwhichyourleadshavebeenplaced.ToturnstimulationONorOFFforabodyregion:• Selectthebodyregionbypressingthedesiredtab.• Pressthe“OFF”buttontostopstimulationtothatregion.WhenstimulationisOFF,the“OFF”buttonisblack.• Pressthe“ON”buttontostartstimulationtothatregion.WhenstimulationisON,the“ON”buttonisgreen.ADJUSTSTIMULATIONLEVELFORABODYREGIONVerifythatyouhaveselectedthecorrectbodyregiontabonthePainControlscreen.• Pressthe“Down”buttontodecreasethestimulationlevel.• Pressthe“Up”buttontoincreasethestimulationlevel.StimulationLevelIndicator:Thestimulationlevelindicatorislocatedbetweenthe“Up”and“Down”buttons.Theindicatormovesupordownasyouadjustthestimulationlevelfortheselectedbodyregion.Theindicatorshowsthecurrentstimulationlevelascomparedtothemaximumsetbyyourdoctor.NOTE:Theindicatorbarisgreenwhenyouhavereachedthemaximumstimulationlevel.
18 INFOTABThe“Info”(Information)tabcontainsthreetabs,the“Device”tab,the“Physician”tab,andthe“Clinic”tab.DEVICETABANDPHYSICIANTABThe“Device”taband“Physician”tabshowthefollowinginformation: StimulatorVoltageInformationNOTE:INSbatteryinformation(doesnotpertaintoexternalTNSdevice).StimulatorIdentificationInformation• StimulatorDeviceFirmwareVersion.• DateINSdevicewasimplanted(doesnotpertaintoexternalTNSdevice).PhysicianInformation• Yourdoctor’sname.• Yourdoctor’scontactphonenumber.• Yourdoctor’semailcontact.CLINICTABThe“Clinic”tabshowsthefollowinginformation:ClinicInformation• Yourclinic’sname.• Yourclinic’saddress.• AfterHoursContact:Aphonenumbertocontactsomeoneincaseofanemergency.
19 USINGYOURTNSDEVICEToconnectyourProgrammertoyourTNS,pushthe“Connect”buttononthePatientProgrammer.MovethePatientProgrammermagnetovertheTNSinacircularmotion.ThiswillallowyoutoadjuststimulationsettingsusingthePatientProgrammer.Toquicklyturnstimulationoff,presstheredbuttonontheTNSformorethan2secondsorpushthe“TurnallStimulationOFF”buttonontheProgrammerscreen.Toenablestimulationafterpressingeitherbutton,youmustconnectwithyourPatientProgrammerandturnthestimulationbackon.USINGYOURINSDEVICEToconnectyourProgrammertoyourINS,pushthe“Connect”buttononthePatientProgrammer.MovethePatientProgrammermagnetovertheimplantlocationinacircularmotion.ThiswillallowyoutoadjuststimulationsettingsusingthePatientProgrammer.Your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
20 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 Patient Programmer is not intended to be connected to other equipment except the Model 3400 Programmer Charger
21 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. 
22 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 0.2 meter, based on transmitters of 80 MHz to 2.5 GHz. Interference may occur in the vicinity of equipment marked with the following symbol: 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.
23 Appendix I: 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 Appendix II: Troubleshooting Pop Up Message Possible Solution Connection with your stimulator was lost. Please recon-nect. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • If you still cannot connect, move the programmer closer to the stimulator. Continue to swipe the magnet over the stimulator. • Move to another location; there may be interference in your current location. Unable to connect to your stimulator. Please contact your physician during normal business hours. • Press “OK” and attempt to reconnect to the stimulator. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • If you still cannot connect, move the programmer closer to the stimulator and continue to swipe the magnet over the stimulator. • Move to another location; there may be interference in your current location. • Contact your doctor during normal business hours if the problem continues. Unable to connect to your stimulator. Please try again. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • If you still cannot connect, move the programmer closer to the stimulator and continue to swipe the magnet over the stimulator. • Move to another location; there may be interference in your current location. Your stimulator battery is low. It will need to be replaced soon. Please contact your physician during normal business hours (only applies to the INS). • Contact your doctor during normal business hours to set up an appointment. Your stimulator has reached Elective Replacement Interval (ERI). Your stimulator battery needs to be replaced. Stimulation has been turned OFF permanently. Please contact your physician during normal business hours (only applies to the INS). • Contact your doctor during normal business hours to set up an appointment. Your stimulator has reached End of Service (EOS) and will not stimulate. It must be replaced. Stimulation for one or more leads has been turned OFF. Please contact your physician during normal business hours. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • Go the Pain Control screen and turn on the lead that has been turned off. • If you are unable to turn it back on, contact your doctor during normal business hours. All stimulation has been turned OFF. Please contact your physician during normal business hours. • Contact your doctor during normal business hours. Stimulation has been turned OFF due to a magnet. Please use your programmer to restore stimulation. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • Go to the Pain Control screen. Turn on each lead one at a time. You have turned all Stimulation OFF. Please use your programmer to restore stimulation. • You have turned off the device by pressing the switch on the TNS or by pressing the “Turn All Stimulation OFF” button on the programmer. • Swipe the programmer over the stimulator to establish connection and reconnect to the device. • Go the Pain Control screen. Turn on the leads that have been turned off. Programmer battery is low. Please recharge. • The battery has reached 30% on the programmer and needs to be recharged.

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