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

Spinal Modulation, Incorporated Clinical Programmer LP0015 Rev Draft FCC PProg

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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



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



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



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.



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.



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).



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.



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.

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



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

NOTE:IfthePatientProgrammerdoesnotturnON,chargethebattery,andtryagain.



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.

 



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

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.



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.



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.



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.



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.



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

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

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.



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

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.



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

-35

3014

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

Table1:LoadImpedance=600ohms

Alllongevityvaluesareinmonths



 Pulsewidth

AmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS

4Hz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



Table1:LoadImpedance=600ohms(Continued)

Alllongevityvaluesareinmonths



  Pulsewidth

  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS

4Hz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



Table2:LoadImpedance=1Kohm

Alllongevityvaluesareinmonths



 Pulsewidth

AmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS

4Hz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



Table2:LoadImpedance=1Kohm(Continued)

Alllongevityvaluesareinmonths



  Pulsewidth

  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS

4Hz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



Table3:LoadImpedance=1.5Kohm

Alllongevityvaluesareinmonths



 Pulsewidth

AmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS

4Hz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



Table3:LoadImpedance=1.5Kohm(Continued)

Alllongevityvaluesareinmonths



  Pulsewidth

  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS

4Hz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



Table4:LoadImpedance=2Kohm

Alllongevityvaluesareinmonths



 Pulsewidth

AmplitudeFrequency40uS100uS 200uS 300uS 400uS 500uS600uS700uS 720uS

4Hz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



Table4:LoadImpedance=2Kohm(Continued)

Alllongevityvaluesareinmonths



  Pulsewidth

  40uS100uS 200uS 300uS 400uS 500uS 600uS700uS 720uS

4Hz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



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.

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

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