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

Spinal Modulation, Incorporated Clinical Programmer LP0014 Rev Draft FCC CProg

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Revised user manual MN-0700



ClinicalProgrammer

ModelMN0700

UserManual



SpinalModulation,Inc.

1135O’BrienDrive

MenloPark,CA94025USA



CAUTION–InvestigationalDevice

LimitedbyFederal(US)LawtoInvestigationalUse



transmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,recording,oranyinformation

storageandretrievalsystems,withouttheexpresswrittenpermissionofSpinalModulation,Inc.



LP0014RevE,June2011



2

TABLEOFCONTENTS

EXPLANATIONOFSYMBOLSONPRODUCTORPACKAGELABELING....................................................................... 4

INTRODUCTION........................................................................................................................................ 5

INDICATIONSFORUSE ............................................................................................................................... 5

DESCRIPTION........................................................................................................................................... 5

WARNINGS............................................................................................................................................. 6

PRECAUTIONS ......................................................................................................................................... 7

CLINICALPROGRAMMERSYSTEMOVERVIEW ................................................................................................. 8

CLINICALPROGRAMMERFEATURES .............................................................................................................. 8

MAGNET ................................................................................................................................................ 9

CHARGINGTHECLINICALPROGRAMMERBATTERY........................................................................................... 9

PROGRAMMERPOWERUP....................................................................................................................... 10

MAINMENU......................................................................................................................................... 10

DEMO ................................................................................................................................................. 10

PROGRAMMERSETUP ............................................................................................................................. 10

CHANGETHEDATE................................................................................................................................. 11

CHANGETHETIME ................................................................................................................................. 11

SWITCHTOFCEPROGRAMMER ............................................................................................................... 11

ESTABLISHINGCOMMUNICATIONWITHTHENSDEVICE .................................................................................. 11

BACKTOMAINMENU ............................................................................................................................ 12

NAVIGATIONANDSCREENELEMENTS.......................................................................................................... 12

NEUROSTIMULATORDASHBOARD.............................................................................................................. 12

PROGRAMMERSTATUSBAR ..................................................................................................................... 13

WORKSPACENAVIGATION ....................................................................................................................... 13

TEMPORARYANDPERMANENTPROGRAMMING ........................................................................................... 14

MOREONEDITINGTEXTFIELDS ................................................................................................................. 14

USINGTHEWORKSPACES......................................................................................................................... 15

PROFILEWORKSPACE.............................................................................................................................. 15

PATIENTINFORMATIONTAB[PROFILE>PATIENT] ....................................................................................... 15

CLINICINFORMATIONTAB[PROFILE>CLINIC]............................................................................................. 16

STIMULATORINFORMATIONTAB[PROFILE>NS] ........................................................................................ 16

LEADSINFORMATIONTAB[PROFILE>LEADS] ............................................................................................. 17

SYSTEMINFORMATIONTAB[PROFILE>SYSTEM]......................................................................................... 17

STIMWORKSPACE.................................................................................................................................. 18

STIMTABS[STIM>TARGETNAME] ..........................................................................................................18

IMPEDANCETABS[STIM>IMPEDANCE] .....................................................................................................21

MAPWORKSPACE.................................................................................................................................. 21

GROUPWORKSPACE............................................................................................................................... 21

LEADTABS[GROUP>GROUPNAME]........................................................................................................ 22

AUTHORIZEDEUROPEANREPRESENTATIVE .................................................................................................. 22

COMPANYCONTACTINFORMATION ........................................................................................................... 22



3

GUIDANCEANDMANUFACTURER’SDECLARATION.......................................................................................... 23

ELECTROMAGNETICEMISSIONS ................................................................................................................23

ELECTROMAGNETICIMMUNITY ................................................................................................................24

APPENDIXI:PROGRAMMABLEPARAMETERSANDVALUES ............................................................................... 27

APPENDIXII:INSBATTERYLIFE ................................................................................................................ 28

APPENDIXIII:TROUBLESHOOTING ............................................................................................................. 37



4

ExplanationofSymbolsonProductorPackageLabeling

ModelNumber

SerialNumber



ReadtheManual

ConsulttheManual



ContentsofPackageareNon‐Sterile



ManufacturingDate

Manufacturer

 Warning.Payattention.

ProtectedagainstElectricShock



Notwaterproof.AppliestotheProgrammerwhenitisnotinits

carryingcase.



Limitedwaterproof.AppliestotheTNS.

AppliestotheProgrammerinitscarryingcase.



TurnstheProgrammerONandOFF.

TurnsstimulationOFFontheTNS.



KeepDry

Storebetween‐10°Cand50°C(14°Fand122°F)



Storebetween0and93%humidity

Thedeviceisaradiotransmitter

Magnet.ShowsthelocationoftheProgrammermagnet.

AustraliaC‐tick

AuthorizedEuropeanRepresentative



5

Introduction

TheClinicalProgrammer(MN0700)ispartoftheSpinalModulationNeurostimulatorSystem.Itis

intendedtobeusedbytheclinicalinvestigatororaSpinalModulationrepresentativetoqueryand

programtheNeurostimulator(NS),toretrievedatafromtheNSandtoallowforadjustmentofthe

patient’stherapy.ThisUserManualgivesdetailedinstructionsonhowtousetheClinicalProgrammer

safely,howtorechargeitandhowtouseittosetupthepatient’spainmanagementtherapy.

IndicationsforUse

TheSpinalModulationNeurostimulatorSystemisindicatedasanaidinthemanagementofchronic,

intractable,neuropathicpainofthelowerlimbs‐includingunilateralorbilateralpain,associatedwiththe

followingconditions:radicularpain,peripheralneuropathies.

Description

PatientswhoareindicatedforSpinalModulation’sImplantableNeurostimulatorSystem(INS)system

willfirstundergoatrialperiodusinganexternalTrialNeurostimulatorSystem(TNS)connectedtoleads

placedwithintheepiduralspacenearthedorsalrootganglion(DRG).Uptofourleadsmaybeplaced

andconnectedtotheNeurostimulator.

Althoughtheleadsandstimulatorhardwareuseddiffer,theprogrammerhardwareandinstructionsfor

programmingtheTNSandINSdevicesarethesame.

NOTE:Inthismanualthegeneralabbreviation“NS”isusedforinformationwhichappliestoboth

TNSandINS.Inallothercasesthespecificabbreviations“TNS”or“INS”areused.

ForspecificdescriptionoftheTNSandINSsystemcomponentsandimplantprocedures,refertothe

relevantlabeling.

TwoprogrammersareavailabletointeractwiththeNSdevice.

1. TheClinicalProgrammerdescribedinthisusermanualisusedtoprogramthestimulation

parametersfortheNS,asdeterminedbytheinvestigator.TheNSdeliverstheprogrammed

stimulationparameters(energy)totheimplantedLeads.

2. ThePatientProgrammerallowsthepatienttoadjustthestimulationsettingsoftheNSdevices

withinlimitspresetbytheinvestigator.ThePatientProgrammeralsoallowsthepatienttoturn

stimulationoff,ifnecessary.Forfurtherinformationandinstructionsrelatedtothepatient

programmer,refertotherespectiveusermanual.



6

Warnings

TheWarningslistedbelowpertaintotheClinicalProgrammeronly:

• TheinvestigatormustbetrainedbySpinalModulationpersonnelbeforeusingtheClinical

Programmer.

• DonotusetheClinicalProgrammerwithaNSdevicethatappearstobefaultyorfailsto

properlycommunicate.

• ImproperuseoftheClinicalProgrammermaycauseirreversibleinjurytothepatient.All

subjectsaretobeawakeandconversantduringtheproceduretominimizethelikelihoodofany

nervedamage.

• AlwayssettheNSdeviceamplitudeto0µAwhenrepositioningaleadorattachingthe

ConnectorCabletotheexternalTNS.Whenrestartingstimulation,increasetheNSamplitude

slowlyuntilthedesiredparesthesiaisachieved.



RFOperatingFrequencies

NearbyequipmentemittingstrongmagneticfieldscaninterferewithRFcommunication,evenifthe

otherequipmentcomplieswithCISPRemissionrequirements.Theoperatingcharacteristicsareas

follows:



MICSband:402‐405MHz



Theeffectiveradiatedpowerisbelowthelimitsasspecifiedin

Europe:ENETSI301839‐2

USAFCC47CFRPart95;95.601‐95.673SubpartE,95.1201‐95.1219

FCCID:Y8L‐MN0700



Thisdevicemaynotinterferewithstationsoperatinginthe400.150–406.000MHzbandinthe

MeteorologicalAids,MeteorologicalSatellite,andEarthExplorationSatelliteServicesandmustaccept

anyinterferencereceived,includinginterferencethatmaycauseundesiredoperation.



7

Precautions

ThefollowingprecautionsshouldbetakentoavoiddamagetotheClinicalProgrammerandtoassure

properfunction:

• DonotdropormishandletheClinicalProgrammer.PhysicaldamagetotheClinicalProgrammer

mayimpairitsfunction.

• DonotspillfluidsonorwashtheClinicalProgrammer.Excessivemoisturemayimpairits

function.Ifcleaningisnecessary,removesoilwithasoftdampcloth.

• DonotuseabrasiveorcausticcleaningproductsontheClinicalProgrammer.

• DonotattempttoopenthecaseoftheClinicalProgrammer.Attemptstoopenthecasemay

exposetheClinicalProgrammertoelementsthatalteritsfunction.

• TheClinicalProgrammerhasaninternalmagnet.KeeptheClinicalProgrammerawayfromany

creditcards,harddrivesormagneticstoragedevicesasitmaydemagnetizethem.

• DonotoperatetheClinicalProgrammeroutsidethetemperaturerangeof‐5°Cto45°C.Rapid

temperaturechangesmayaffectproperdeviceoperation.

• DonotstoretheClinicalProgrammeroutsidethetemperaturerangeof‐10°Cto50°C.

• DonotleavetheClinicalProgrammerinacarorotherplaceswheretemperaturescanexceed

50°C.

• DonotburnorotherwisedisposeoftheClinicalProgrammer.Firemaycausetheinternal

batterytoexplode.

• DonotallowunauthorizeduseoftheClinicalProgrammertoavoidinjurytopatients.

• TheNSdevicecanonlybeprogrammedusingSpinalModulation’sClinicalorPatient

Programmer.Donottrytouseanyothermanufacturer’sdevicetoprogramit.

• DonotusetheClinicalProgrammerorNSinthepresenceofexplosiveorflammablegasesas

thismaycauseseriousinjury.

• IfthereisanyconcernregardingtheproperfunctionoftheSpinalModulationNSSystem,please

contactyourSpinalModulationrepresentative.

• DonotusetheProgrammerChargerifthepowercordisdamaged,excessivelywornorfrayed.

ThismaycauseinjuryordamagetheProgrammer.

• Frequentprogrammingoftheimplanteddevicewillcausethebatterytodepletefaster.Avoid

unnecessaryprogramming.

• TheTNSshouldalwaysbeworneitheroutsideofclothingoroutsidethedressingholdingthe

leadsinplace.



8

ClinicalProgrammerSystemOverview

TheClinicalProgrammerallowsyoutoestablishtwo‐waycommunicationwiththepatient’sNSdevice

forqueryingandprogramming.

Itisaportable,hand‐helddevicethatcanbepluggedintoapoweroutletorbepoweredbyaninternal

battery.ThebatteryisrechargeableusingtheProgrammerChargerprovidedandapoweroutlet.

TheClinicalProgrammerSystemincludes:

• ClinicalProgrammer(withStylus)MN0700

• ProgrammerChargerMN3400

• ExternalAuxiliaryMagnetMN3300

• CarryingCaseMN3500

• ClinicalProgrammerUserManual(thisdocument)



Stylus ProgrammerChargerClinicalProgrammer



TheCarryingCasewillkeeptheProgrammerdry.StoreandtransporttheProgrammerintheCarrying

Casewhenyouarenotusingit.



ClinicalProgrammerFeatures

WiththeClinicalProgrammer,youcan:

• TurnOFFallstimulation.

• TurnstimulationONforuptofourleadsandmeasureleadimpedance.

• Changestimulationsettingsforeachlead.

• ConfigurePatientControlledTherapysettingsforeachlead.

• Enterpatientandleadidentificationinformation,clinicianandclinicnameandcontact

information,andclinician’snotes.

• Createandnamegroupsofstimulationsetswitheachgroupcontaininguptofourleadswith

differentsettingsoneachlead.

• Performarealtimetrial(test)toassessthepatientstimulationresponseforeachlead.

• Acquireidentification,diagnostic,andhistoricinformationabouttheNSdevice.



9

Magnet

AmagnetisbuiltintotheClinicalProgrammer.ItislocatedonthebacksideoftheProgrammer

underneaththeindentwiththemagnetsymbol(shownbelow).

TheNSsystemhasthecapabilityofdetectingthepresenceofamagnet.ThemagnetputstheNSdevice

incommunicationmode,allowingittoconnecttotheProgrammer.

Analternatefunctionofthemagnetisthatbyholdingthemagnetoverthedevicelongenough,all

stimulationtherapywillbeswitchedoff.(Referto“Workspace‐Profile>System”sectionformore

information).

 

PRECAUTION:Keeptheprogrammermagnetawayfromcreditcards.Itmayerasethe

magneticstripandrenderthecarduseless.

ChargingtheClinicalProgrammerBattery

YouwillneedtheProgrammerChargerprovided,tochargethebatteryinyourClinicalProgrammer.It

takesapproximately2–4hourstofullychargethebattery.Thebatterychargelevelisindicatedinthe

“ProgrammerStatusBar”atthebottomofthescreen.

1. ConnecttheChargertoapoweroutlet.

Input:100‐240VAC,50‐60Hz,0.6A

Output:5V 3.0A

2. ConnecttheChargertoyourProgrammer.

3. Whenthebatteryischarging,thebatteryicononthescreencontains“AC”.Whenthecharging

iscomplete,theindicatornexttothebatteryiconwillbeatapproximately100%.

WhentheClinicalProgrammerisconnectedtoapoweroutletasdescribedabove,itispoweredbythe

outletandwillnotusebatterypower.WhentheClinicalProgrammerischarging,theProgrammer

batteryiconreflectsthecurrentstatusofthebattery.ConnecttheClinicalProgrammertotheCharger

andattachtoanoutletregularlytokeepitcharged.



10

ProgrammerPowerUp

TurntheClinicalProgrammerONbypressingthe““button.TheMainMenuwillbedisplayed.

NOTE:IftheClinicalProgrammerscreendoesnotturnon,followtheinstructionsforchargingthe

battery,andtryagain.

MainMenu

TheMainMenudisplaysthreeprimaryfunctions:

• Demo:Putsthesystemintoastand‐alonedemomode

allowingyoutouseallprogrammerfunctionswithout

itbeingconnectedtoaNS.

• ProgrammerSetup:AllowsyoutosettheClinical

Programmerdateandtime,activatetheFCE

WorkspaceontheProgrammer,andsetandmodify

theProgrammerpassword.

• ConnecttoStimulator:Opensascreenthatallowsyou

tocommunicatewiththeNSdevice.

TheMainMenuidentifiesthedeviceastheSpinalModulation

ClinicalProgrammer.Furthermore,Programmer’sSerial

Number,SoftwareVersion,BasestationFirmwareVersionandManufacturingdatearedisplayed.

AtthebottomoftheMainMenu,thestatusbardisplaystheProgrammer–NSconnectionstatus,the

batterychargelevelandthetime.RefertothesectionontheProgrammerStatusBarinthisUser

Manual.

Demo

Select“Demo”ontheMainMenutoinitiateDemomode.

ButtonswillbepurpletoindicatethattheProgrammeris

operatinginDemomode.NoNSdeviceisneededforthis

mode—justtheProgrammer. TheProgrammerwillhave

simulatedNSdataonitandwillsimulatetheRFcommunicationwiththeNS. Thismeansthatatthe

startofeveryDemosession,thedatawillalwaysbethesame.

ProgrammerSetup

Select“ProgrammerSetup”ontheMainMenutogetthe

setupscreen.



11

ChangetheDate

Selectthedropdownarrowontherightsideofthe“Set

Date”box.Acalendarwillappearandyoucansetthe

month,dayandyearusingyourstylus.

ChangetheTime

Tochangethetime(24hourformat),firstselectthehouror

minutefieldthatyouwouldliketochange.

Tochangetheselectedfield,usethe“Up”or“Down”

arrowstoincrease,decreaseortogglethesetting.

NOTE:EstablishingaconnectionupdatestheNS

device’sclocktothenewlysettime.

SwitchtoFCEProgrammer

BycheckingthisboxtheClinicalProgrammerwillget

additionalfunctionality,whichshouldonlybeusedbySpinalModulation’sFieldClinicalEngineersand

Staff.

EstablishingCommunicationwiththeNSDevice

Tochangethepatient’sstimulationsettings,youmustfirstestablishcommunicationbetweenthe

ClinicalProgrammerandthepatient’sNSdevice.

1. MakesurethattheClinicalProgrammeristurned

onandtheMainMenuscreenisdisplayed

2. Press“ConnecttoStimulator”ontheMainMenu.

3. Selectthetextboxnextto“StimulatorSN:”

4. Entertheserialnumberusingthepop‐up

keyboard.TheProgrammeriscasesensitivesouse

uppercaselettersonly.

IftheserialnumberformatisvalidforaNSdevice,the

“Connect”buttonwillbeenabled.

5. Pressthe“Connect”button.

Afterpressingthe“Connect”button,the“Cancel”button

becomesenabled.IftheCancelbuttonispressed,the

telemetryconnectioniscancelled.



12

6. MovetheClinicalProgrammermagnetovertheNSdeviceinacircularmotiontoconnect.

Theindicatorstatusbaronthebottomleftofthescreenwilldisplay“Connected”iftheconnection

attemptissuccessful.IftheProgrammercouldnotcommunicatewiththeNSdevice,anerrormessage

willappearand“Disconnected”willbedisplayedinthestatusbar.

NOTE:Ifafter2minutestheClinicalProgrammerhasfailedtocommunicatewiththeNSdevice,the

programmerwillautomaticallycanceltheconnectionattempt.TrytocommunicatewiththeNS

devicebypressingthe“Connect”buttonagainmovingthemagnetsymbolontheClinical

ProgrammerovertheNSdeviceinacircularfashion.

Whenasuccessfulconnectionisestablished,theProgrammerchimesandtheNSdevicewillbequeried.

7. ForthedurationoftheprogrammingsessionkeeptheClinicalProgrammerwithin6feetofthe

NSdevice.Movingtheprogrammertoofarawaymaycausetelemetryconnectiontobelost.

BacktoMainMenu

LocatedatthebottomrightsideoftheProgrammerConnectwindow,the“Exit”buttonisusedtoreturn

totheMainMenu.

Navigationandscreenelements

NeurostimulatorDashboard



OncetheselectedNSdeviceisconnectedtotheClinical

Programmer,theNSDashboardisdisplayedinthescreen’s

headerproviding:

• PatientID:thepatient’sIDNumber.

• StimulatorSerialNumber:theNSdevice’sserial

number.

• Alertsbutton:Thebuttonturnsorangewhenany

oftheNSSystemAlertsbecomeactive.Whenthe

“Alerts”buttonisorange,pressthebuttonto

displayawindowshowingdetailsofalltheSystem

Alerts.Anexampleofthescreenshotisshownto

theright.



13

ProgrammerStatusBar



LocatedatthebottomoftheClinicalProgrammerscreen,theProgrammerStatusBardisplays:

• Programmer‐NSConnectionStatus:Displaysthestatusofthecommunicationbetweenthe

ClinicalProgrammerandtheNSdevice:“Connecting”isdisplayedwhenestablishinga

connection.“Connected”isdisplayedwhenthereiscommunicationbetweentheClinical

ProgrammerandtheNSdevice.“Disconnected”isdisplayedwhenthereisnocommunication

betweentheClinicalProgrammerandtheNSdevice.

• ProgrammerBatteryLevel:DisplaystheClinicalProgrammerbatterychargelevel.Itis

recommendedthatyourProgrammerbeconnectedtothepowersupplyprovidedandattached

toanoutletwhennotinuse.

• ProgrammerClock:Displaysthetime.SeeUserManualsectiononChangetheTime.

WorkspaceNavigation

OncetheNSisconnected,tabsaredisplayedforthe

systems’fourmainworkspaces(“Profile”,“Stim”,“Map”

and“Group”).TheWorkspacesareusedtoviewand

programtheNStherapysettingsandtoobtaindiagnostic

information.Arecordoftheprogrammedsettingsanddiagnosticinformationisgeneratedafterevery

session.AfifthWorkspacelabeled“FCE”willonlyappearwhenFCEmodeisON.

Workspacescreensandsub‐screensarenavigatedbyselectingthelabeledtabs.Onceselected,atab

willbehighlightedinyellow.

LocatedatthebottomofeachoftheWorkspacesarethe

“ALL”,“Program”and“Exit”buttons.

• Exitbutton:isusedtoclosethecurrentwindow,endthepatienttherapysession,andreturnto

theMainMenu.

NOTE:ReturningtotheMainMenuorturningoffyourProgrammerwillnotchangeanyofthe

programmedNSsettings.

NOTE:Whenprogrammingiscomplete,selectthe“Exit”buttontoconservepower.

• Programbutton:programsallchangesmadewithinthecurrentWorkspace.

• ALLbutton:isusedtoturnallstimulationoff.



14

TemporaryandPermanentProgramming

WheneverachangeismadetoaparametervalueorotherdatafieldwhiletheNSiswithintelemetry

range,thisvalueimmediatelybecomestemporarilyactive.Thecorrespondingvalueordataselection

appearinaredboldunderlinedfont.

Temporaryprogrammedvaluesortextdatacanbepermanentlyprogrammedbypressingtheprogram

button.Thefontcolorchangesfromredtoblack.

NOTE:WhenleavingaWorkspacewhilevaluesaretemporarilyactiveyouwillbepromptedtoeither

programthesevaluespermanentlyorcancelthependingchanges.

NOTE:ParameterscanbetemporarilyactiveonmultipletabsofthesameWorkspace.

Moreoneditingtextfields

NOTE:Selectingatextfieldwillpopupakeyboardatthebottomofthescreen,allowingthe

informationtoberevised.Toclosethekeyboardaftermodifyingtheentry,pressthekeyboardkey

centeredinthebluebaratthebottomofthescreen.

Whiletextfieldsarebeingeditedtheyappearinablackbold

font(nounderline).Atthesametimetotherightofthetext

fieldareddotisshownindicatingthateditingisinprogress.

Editingcanbeinprogressformultiplefieldsatthesame

time.

Onceeditingforafieldiscomplete,tapthered‐dottomake

thechangetemporarilyactive.Thereddotdisappearsand

thefontchangesfromblackboldtoredboldunderlined.

Onlyuponpressingtheprogrammingbuttondoesthechange

becomepermanentlyprogrammedandthefontcolor

changesfromredtoblack.





15

UsingtheWorkspaces

ProfileWorkspace

Pressthe“Profile”tabtoaccesstheProfileWorkspace.TheProfileWorkspaceisdividedintofivetabs

(“Patient”,“Clinic”,“NS”,“Leads”and“System”)whichareusedto:

• Enterpatientinformation;

• Entercliniciancontactinformation;

• EnterNSdeviceinformation;

• Enterleadidentificationinformation;

• Changebasicsystemparameters;

PatientInformationTab[Profile>Patient]

Enterormodifythepatientinformationinthefieldsprovided:

  



• PatientName:Enterthepatient’snameusingtheon‐screenkeyboard.

• ID:Enterthepatient’suniqueidentificationusingtheon‐screenkeyboard.

• DateofBirth:Enterthepatient'sdateofbirthusingthedrop‐downcalendar.

• PrimaryandsecondaryDiagnosis:Selectthepatient'sdiagnosisfromadrop‐downlist(Referto

AppendixIforselectionset)

• Notes:Enternotesifneeded.



16

ClinicInformationTab[Profile>Clinic]

Enterormodifythephysicianandclinicinformationinthetext

fieldsprovided:

• PhysicianName

• ClinicName

• Clinicafterhourscontactphonenumber

• ClinicPhonenumber

• ClinicEmail

• ClinicAddress



StimulatorInformationTab[Profile>NS]

TheNStabprovidesasummaryofinformationrelatedtothe

NS.

• DateofImplant:EntertheStimulatordateofuse

usingthedrop‐downcalendar.

• Implantbatteryvoltage:thecurrentbatteryvoltageis

automaticallydisplayedhere.

• History:showsrecentprogramminghistory.

NOTE:ThebatteryinformationpertainstoanINSanddoesnot

pertaintotheTNS.



17

LeadsInformationTab[Profile>Leads]

Lead1throughLead4arethedefaultlabelsusedto

identifytheimplantedleadsinthe“Stim”Workspace.Itis

recommendedthatthesenamesbechangedinto

somethingmoremeaningful,forexamplethebodyregion

itcovers.

• TargetName:foreachoftheimplantedleads,

enterthebodyregioncovered(textfield).

ForeachoftheleadsentertheLotandModelnumber:

• Lot#:enterthelastfourdigitsoftheLotnumber

foundontheleadpackaging.

• Model#:entertheleadModelnumber.



SystemInformationTab[Profile>System]

Fromthesystemtabthefollowingsystemparameterscanbe

managed:

• PeriodicImpedanceinterval:settheperiodicitywith

whichyouwantthesystemtomeasurelead

impedance.

• Follow‐upPeriod:Acalculatedfieldwhichdisplays

therecommendedfollow‐uptimebasedonthe

programmedsettings.Itisanindicatorofwhenthe

programmerwillrunoutofmemoryandwillbeginto

overwriteolddata.

• RampDuration:Rampdurationishowlongittakes

fortheNStoreachtherequestedamplitude.Ifset

to8seconds,theNSwilltake8secondstogetfrom0

totherequestedamplitudewhenaleadisswitched

fromnotenabledtoenabled.Rampingalsooccurs

whenthestepbetweenthecurrentamplitudeand

thenextamplitudeisgreaterthan100mV.

• MagnetTurnoffTime:allowsyoutocontrolhowlongittakesbeforeamagnetheldoverthe

deviceswitchesoffdeliveredtherapy.



18

StimWorkspace

Pressthe“Stim”tabtoaccesstheStimulationSettingsWorkspace.TheStimulationSettingsWorkspace

isdividedintofivetabswhichareusedto:

• Activate(turnon)uptofourleads

• Adjustelectrodeconfigurations

• Measureimpedance

• Setnominalvaluestobeginstimulation

• Performtrialmapping

• Confirmtheresponseandsensationofspecificbodyregionstobestimulated

StimTabs[Stim>TargetName]

TheStimtabsarethemaintabsfromwhichtherapyis

controlledandprogrammed.Thiscanbedoneeither

temporarily(testing)orpermanently.

• Selectgroup:selectthegroupforwhichyouwant

tochangethestimulationsettings.

NOTE:intheGroupWorkspace,uptofourdifferent

groupscanbedefinedeachwiththeirownstimulation

parameters.Agroupcanbelinkedforexampletoa

specificactivityorposture.RefertotheGroup

Workspacesectioninthismanualformore

information.

• Selectthetab:labeledwiththetargetforwhich

youwanttoadaptstimulationparameters.(Inthe

samplescreeneg.“LFoot”)

NOTE:Thereareuptofourtabsthatcanbelabeledwiththebodyregioninwhichstimulationwith

thecorrespondingleadistargeting(definedinProfile>Leads).Foreachbodyregion(lead)

stimulationcanbeadjustedindependently.

• ElectrodeConfiguration:Eachleadhasfourelectrodeseachofwhichcanbeprogrammedwith

apositiveornegativepolarity,orbeprogrammedasneutral(off).Theremustbeatleastone

positiveandonenegativeelectrodebeforetheClinicalProgrammerallowstheamplitudetobe

adjustedandfortheleadtobeenabled.

1. Selectoneofthefourelectrodesbyclickingonitusingthestylus.Clickingoncewillturnthe

electrodepositive(“+”),clickingittwicewillturnitnegative(“‐“)andclickingitthreetimes

willturnitNeutral(“N”)again.Toexitfromtheelectrodeeditingmode,clickonthe

neighboringImpedancebox.

2. Continue,bysettingeachofimplantedleadswithatleastonepositiveandonenegative

electrodeforeachbodyregiontobetreated.

• Impedance:Pressthe“InstantImpedance”button(“Ω“)tomeasurethelead’simpedance.

Oncepressed,theimpedancevaluewillbedisplayedunderneaththebutton.IfyouwanttheNS



19

tousethisInstantImpedancevaluefortherapydelivery,pressthe“TransferInstantImpedance”

button(“Æ“).

NOTE:Thepatientmayfeeltheeffectoftheimpedancemeasurement.Alertthepatienttothe

possiblestimulation.

NOTE:Atransferredimpedancevalueisrequiredbeforeotherstimulationparameterscanbe

selected.

• Enable:Select“ON”toenabletheleadsothatitprovidesstimulationtherapytothepatient.

Select“OFF”iftheleadisnotbeingused.

o WhenEnableisON,the“ON”buttonwillturnthecolorgreen.

o WhenEnableisOFF,the“OFF”buttonwillturnthecolorblack.

o Thebuttonborderisrediftheactivationstateisdifferentfromtheprogrammedvalue.

WARNING:OnceEnableisONforthistarget,anyparameterchangewillbe

immediatelyactive.

NOTE:Ifaleadisenabledonanonactivetabofthe“Stim”Workspace,thetabwillturnthecolor

green.Theactivetabstaysthecoloryellow.

NOTE:Theleadisdisabledandtheamplitudeisautomaticallychangedtozerowhenthelead

electrodeconfigurationchanges.Theleadelectrodeconfigurationmustbevalidpriortoactivating

thelead.Avalidleadconfigurationmustincludeatleastonepositiveandonenegativeelectrode.



20

• Location:Enterthespinallevelwherestimulationtherapyisdeliveredbythistriallead

• PulseParameters:Toselectandchangepulseparameters,firstpressthedesiredincrement

level:Fine(>),Medium(>>),Coarse(>>>).

 Amplitudesbelow2.0mA(>:25µA,>>:50µA,>>>:200µA)

 Amplitudesabove2.0mA(>:50µA,>>:100µA,>>>:400µA)

 PulseWidth(>:10µs,>>:40µs,>>>:100µs)

 Frequency(>:2Hz,>>:4Hz,>>>:10Hz)

 TheUP(^)andDown(∨)buttonsnexttothespecificpulseparameterwillallowtheuser

tochangethesettingatthedesiredincrements.

Thefollowingtableliststhepulseparameters,theirrange,incrementsanddefaultvalue:

SpecificationsRangeStepSizeDefaultValue

PulseAmplitude‐PA(µA)

(Dependingonmeasuredimpedance)

0–6000µA25µA:0‐2000µA

50µA:2000‐6000µA

0µA

MaximumPulseAmplitude‐Max(µA)

ProgrammablebyPatient

SameasPASameasPA0µA

PulseWidth–PW(µs)40–720µs10µs40µs

PulseFrequency‐PF(Hz)4–100Hz2Hz60Hz



• MaximumAmplitude:Enterthemaximumstimulationamplitude,fromtheclinicallyset

amplitudeupto6.0mAthatthepatientisallowedtosetforeachlead.

WARNING:Unlessthestimulationsettingsareknownforaspecificpatient,startwitha

PulseAmplitudeof0µA.

• StimulusResponse:Allowsyoutoassignadescriptortoasetofprogrammedpulseparameters.

Thedescriptoriscomposedofabodyregionwherethesensationisfeltandadescriptionofthe

sensation.(Eg.UpperBack&MassagingÆUpperBackMassaging).AStimulusResponsemust

beselectedinordertoProgramthesetofpulseparameters.TheLoadOtherbuttonpullsdown

adropdownmenuandallowstheusertoloadanotherStimulusResponsethathasbeen

previouslysavedforthatlead.

NOTE:Whenrestartingstimulation,increasetheamplitudeslowlyuntilthedesiredeffectis

achieved.



21

ImpedanceTabs[Stim>Impedance]

Theimpedancebutton(Ω)initiatesimpedance

measurementsbetweenadjacentelectrodecouplesinallof

theconfiguredleadsanddisplaysontheImpscreen.



MapWorkspace

Pressthe“Map”tabtoaccesstheMapWorkspace.

TheMapWorkspaceallowsyoutodefinewhichlead

connectstoeachoftheNSports.Itthereforeprovidesthe

abilitytoautomaticallymovesavedsettingsfromonePort

toanother.

Eachleadisidentifiedbyitslocation(spinallevel)enteredin

theStimWorkspace.



GroupWorkspace

Pressthe“Group”tabtoaccessGroupWorkspace.

TheGroupWorkspaceisdividedintofourtabs(Groups)bydefaultnamed“Awake”,“Sleeping”,

Exercising”and“Sleeping”).EachtabsummarizesGroupspecificsettingsforeachoftheimplanted

leads.TheseGroupscanbeeasilyprogrammedasneededbythepatientusingthePatientProgrammer.



22

LeadTabs[Group>GroupName]

EachGroupcanbeconfiguredbyselectingthedesiredtab.

• Name:TheGroupcanberenamedhere(free‐form

textentry)

• ForPatientUse:TheGroupwillbedisplayedon

thePatientProgrammeronlyifthisboxischecked.

NotethatthecurrentlyactiveGroupmustbe

checked/enabled.

• OnProgrammer/OnStimulator:Thesebuttons

toggletoallowtheusertovieweitherthe

Programmervalues(possiblynotprogrammedyet

totheStimulator)orthevaluesprogrammedon

theStimulator

• Lead1throughLead4:TheStimulusResponsefor

eachLeadwithinaGroupcanbechangedhere.

StimulusResponsesthathavebeenpreviously

savedforthatLeadwillbeshowninthedropdown

menu.

• Response/Discard:UnwantedStimulusResponsedefinitionscanbediscardedhere.Thismay

beneededoncetheuserhasusedupthemaximumnumberofStimulusResponses(12).



TheSpinalModulationNeurostimulatorSystemcomplieswiththefollowingInternationalStandards

• IEC60601‐1:2005

• IEC60601‐1‐11:2010

• IEC60601‐1‐2:2007

• ISO14708‐1:2000

• ISO14708‐3:2008



AUTHORIZED EUROPEAN REPRESENTATIVE

MediTech Strategic Consultants B.V.

Maastrichterlaan 127-129

6291 EN Vaals, Netherlands



COMPANY CONTACT INFORMATION

Spinal Modulation, Inc.

1135 O’Brien Drive

Menlo Park, CA 94025

U.S.A.

Telephone: (650) 543-6800 (24 hour support line)

Fax: (650) 327-2336

Email: clinicalsupport@spinalmodulation.com



23



GUIDANCE AND MANUFACTURER’S DECLARATION

ElectromagneticEmissions

TheSpinalModulationNeurostimulatorSystemisintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulatorSystemshouldassurethat

itisusedinsuchanenvironment.

EmissionstestComplianceElectromagneticenvironment–guidance

RFEmissions1Group2TheSpinalModulationNeurostimulatorSystemmustemit

electromagneticenergyinordertoperformitsintended

function.Nearbyelectronicequipmentmaybeaffected.

RFemissions

CISPR11

ClassB

Harmonicemissions

IEC61000‐3‐2

ClassB

Voltagefluctuations/

flickeremissions

IEC61000‐3‐3

Complies

TheSpinalModulationNeurostimulatorSystemissuitablefor

useinallestablishments,includingdomesticestablishments

andthosedirectlyconnectedtothepubliclowvoltagepower

supplynetworkthatsuppliesbuildingsusedfordomestic

purposes.

CISPR14‐1CompliesTheClinicalProgrammerisnotintendedtobeconnectedto

otherequipmentexcepttheModel3400ProgrammerCharger



24



Guidanceandmanufacturer’sdeclaration

ElectromagneticImmunity

TheSpinalModulationNeurostimulatorSystemisintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulatorSystemshouldassurethat

itisusedinsuchanenvironment.

ImmunityIEC60601

TestLevel

Compliance

Level Electromagneticenvironment

guidance

Electrostaticdischarge

(ESD)

IEC61000‐4‐2±6kV

contact

±8kVair

Floorsshouldbewood,concreteor

ceramictile.Iffloorsarecovered

withsyntheticmaterial,therelative

humidityshouldbeatleast30%.

Electricalfast

transient/burst

IEC61000‐4‐4

±2kVforpowersupplylines

±1kVforinput/outputlines

PassMainspowerqualityshouldbethat

ofatypicalcommercialorhome

environment

Surge

IEC61000‐4‐5

±1kVline(s)toline(s)

±2kVline(s)toearth



Mainspowerqualityshouldbethat

ofatypicalcommercialorhome

environment

Voltagedips,short

interruptionsand

voltagevariationson

powersupply

inputlines

IEC 61000-4-11

<5%UT(>95%dipinUT)

for0,5cycle

40%UT(60%dipinUT)

for5cycles

70%UT(30%dipinUT)

for25cycles

<5%UT(>95%dipinUT)

for5s

NOTE UT is the a.c. mains voltage

prior to application of the test level.

Mainspowerqualityshouldbethat

ofatypicalcommercialorhome

environment

Powerfrequency

(50/60Hz)magnetic

field

IEC61000‐4‐8



3A/mPowerfrequencymagneticfields

shouldbeatlevelscharacteristicof

atypicallocationinatypical

commercial,hospital,orhome

environment.



25



Guidanceandmanufacturer’sdeclaration

ElectromagneticImmunity

TheSpinalModulationNeurostimulationSystemisintendedforuseintheelectromagneticenvironment

specifiedbelow.ThecustomerortheuseroftheSpinalModulationNeurostimulationSystemshouldassurethat

itisusedinsuchanenvironment

ImmunitytestIEC60601TEST

LEVEL

Compliance

level

Electromagneticenvironmentguidance

ConductedRF

IEC61000‐4‐6



RadiatedRF

IEC61000‐4‐3



3Vrms

150kHzto80MHz



3V/m

80MHzto2,5GHz

3V



3V/m

PortableandmobileRFcommunications

equipmentshouldbeusednoclosertoany

partofSpinalModulationNeurostimulation

System,thantherecommendedseparation

distancecalculatedfromtheequation

applicabletothefrequencyofthe

transmitter.

Therecommendedseparationdistanceisa

minimumof0.2meterfortransmittersof

80MHzto2.5GHz

Interferencemayoccurinthevicinityof

equipmentmarkedwiththefollowing

symbol:



NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.

NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorption

andreflectionfromstructures,objectsandpeople.



26



RecommendedseparationdistancesbetweenportableandmobileRFcommunicationsequipment

andtheSpinalModulationNeurostimulationSystem

TheSpinalModulationNeurostimulationSystemisintendedforuseinanelectromagneticenvironmentinwhich

radiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheSpinalModulationNeurostimulation

Systemcanhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableand

mobileRFcommunicationsequipment(transmitters)andtheSystem

Separationdistanceaccordingtofrequencyoftransmitter

m

Ratedmaximum

outputpowerof

transmitter

W

150kHzto80MHz80MHzto800MHz800MHzto2.5GHz

0.010.12m0.12m0.23m

0.10.37m0.37m0.74m

11.17m1.17m2.33m

103.70m3.70m7.37m

10011.70m11.70m23.30m

NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.

NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorption

andreflectionfromstructures,objectsandpeople.



27



AppendixI:Programmableparametersandvalues



ParameterProgrammableValuesDefault

PulseAmplitude0–6000µA

0‐2000µA(25µAincrements)

2000‐6000µA(50µAincrements)

0µA

MaximumPulseAmplitudeSameasPulseAmplitude0µA

PulseWidth40–720µs(10µsincrements)40µs

PulseFrequency4–100Hz(2Hzincrements)60Hz

 

DataFieldSelectableValues

Diagnosis

(PrimaryandSecondary)

AbdominalPain;AxialLowBackPain;AxialNeckPain;CRPSType1;

CRPSType2;DiabeticPeripheralNeuropathy;FBSS;FNSS;Lower

ExtremityNeuropathicPain;NeuropathicPain;Other;Peripheral

Neuropathy;PhantomPain;Post‐HerpeticNeuralgia;PostSurgical

Pain;RadicularArmPain;RadicularLegPain;ThoracicPain;Upper

ExtremityNeuropathicPain;VisceralPain;



PeriodicImpedanceIntervalOff;30s;1min;5min;20min;30min;1h;12h;1days;10days;30

days



LeadModelNumberMN0300;MN0400

StimulusResponseAnatomy Off;Neck;Shoulder;Scapula;UpperBack;MiddleBack;LowerBack;

Back&Leg;Thigh;Knee;LowerLeg;Ankle;Foot(top);Foot(bottom);

Toes;Chest;Axila;Ribs;Abdomen;Hip;Groin;UpperArm;Elbow;

Forearm;Hands;Fingers



StimulusResponseSensationOff;Burning;Buzzing;Cold;Comforting;Cramping;Heavy;Massaging;

Numb;Other;Pain;Paresthesia;Pressure;Relief;Soothing;Spasm;

Tapping;Tingling;Vibrating;Warm



SpineLocationLL1;RL1;LL2;RL2;LL3;RL3;LL4;RL4;LL5;RL5;LT1;RT1;LT2;R

T2;LT3;RT3;LT4;RT4;LT5;RT5;LT6;RT6;LT7;RT7;LT8;RT8;L

T9;RT9;LT10;RT10;LT11;RT11;LT12;RT12;LS1;RS1;LS2;RS2;

LS3;RS3;LS4;RS4;LS5;RS5;LC1;RC1;LC2;RC2;LC3;RC3;LC4;

RC4;LC5;RC5;LC6;RC6;LC7;RC7;LC8;RC8



MagnetTurnoffTimeOff;1s;2s;3s;4s;5s;6s;7s;8s;9s;10s;15s;20s;25s;30s;40

s;50s;1min;70s;80s;90s;100s;110s;2min



RampDuration0s;1s;2s;3s;4s;5s;6s;7s;8s



28

AppendixII:INSBatteryLife

ThefollowingfourtablesestimateINSbatterylifeunderthegivenloadimpedanceconditions.

Tables1through4listestimatedlongevitybasedon1‐leadstimulation,active24hoursaday.To

estimatelongevityformultipleactiveleadsandtoaccountfordailyusage,usethefollowingformula:



Where,



C2 = Longevity for Lead 2 Settings Daily Usage Lead 2

-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



29

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



30

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



31

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



32



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



33



Table3:LoadImpedance=1.5Kohm

Alllongevityvaluesareinmonths



 Pulsewidth

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



34



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



35



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



36



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



37

AppendixIII:Troubleshooting

Pop‐upMessagesConditionButtonsResolution

AllstimulationhasbeenturnedOFF. Allstimulationturnedoffduetodata

corruptionorDevicebeingin

Hibernatemode.

“OK”ContactyourSpinal

Modulation

Representative.

CancelledConnectRequestCancelwaspressedwithconnecting

attemptinprogress.

 

Changessincelastprogrammingwere

lostduetolossofconnectionwiththe

stimulator.Pleasereconnectto

stimulator.

Communicationwaslostpriorto

programmingattempt.

“OK”Reconnectto

stimulatorandre‐enter

programchanges.

Connectedtostimulator.

Communicationispoor.

AllRFchannelshavenoiselevels

abovethenoisethreshold.

 Trymovingtoanarea

withfewersourcesof

noise.

Connectingtostimulator...“Connect”buttononthemainmenu

waspressed.

 

ConnectionEstablished.Connectionattemptwassuccessful.“OK”

Connectionwithstimulatorwaslost.

Pleasereconnect.

DroppedRFconnection."Yes"

"No"

"Cancel"



Doyouwanttoprogramchanges?AnewWorkspaceorExitbuttonwas

selectedwithoutsaving

(programming)changes.

“OK”

InvalidFCEpassword.Pleasetryagain.InvalidFCEpasswordwasentered.“OK”OnlySpinalModulation

representativesshould

accesstheFCEmode.

LeadNdetectedaCurrentTooHigh

condition.

Duringanimpedancemeasurement,

themeasuredcurrentwastoohigh.

“OK”Repeatmeasurement.

Ifproblemreoccurs,

contactyourSpinal

Modulation

representative.

LeadNimpedanceofNNNΩisoutof

range.

Leadimpedanceisoutofrange“OK”Repeatmeasurement

oracceptasis.

Maximumstimulationoutputhasbeen

reached.

Maximumstimulationoutputhas

beenreached(5.2V).

“OK”Investigatelead

integrity.

PleasespecifyaStimulusResponse

beforeprogramming

Attempttoprogramasetofpulse

parameterswithoutaStimulus

ResponseName.

“OK”Selectstimulus

response.

Programmerbatteryislow.Please

recharge.

PDAbatteryreaches30%.“OK”Rechargeassoonas

possible.

Programmerisbootingafterareset.

WhenyouclickOKtheProgrammerwill

switchoff.PressthePowerbuttonto

restart.

HardwareresetButtononthePDA

waspressedortheProgrammeris

launchedforthefirsttime.

PressPowerbutton.

Programmerstoragespaceisfull.File

logginghasstopped.Pleasecontact

yourSpinalModulationrepresentative

formaintenance.

PDAstorageisfull.Afteruser

acknowledgement,normaloperation

continues.

“OK”ContactyourSpinal

Modulation

Representative.



Pop‐upMessages(Cont.)ConditionButtonsResolution



38

Programmerstoragespaceislow.

PleasecontactyourSpinalModulation

representativeformaintenance.

PDAstorageisnearingfullcapacity

(logfilesarestoredonthePDAwith

eachsignificantoperationsuchas

programming).Messageisdisplayed

andfileloggingshouldcontinue.

Normaloperationcontinuesafter

useracknowledgement.

“OK”ContactyourSpinal

Modulation

Representative.

Stimulationforoneormoreleadshas

beenturnedOFF.

Oneormoreleadsturnedoffdueto

LowImpedance.

“OK”Performimpedance

measurementandre‐

enableifwithinrange.

Otherwise,investigate

leadintegrity.

StimulationhasbeenturnedOFFdueto

amagnet.

Stimulationcanbeturnedoffby

applyingamagnetfortheduration

specifiedbytheMagnetTurnoffTime

programmableparameter.

“OK”

StimulationhasbeenturnedOFF.Stimulationcanbeturnedoff,either

bythe“AllStimOFF”softwarebutton

ontheINSprogrammer,ortheOff

switchontheTNS.

“OK”

StimulatorbatteryhasreachedEndof

Service(EOS).Stimulationhasbeen

turnedOFFpermanently.

BatteryhasreachedEOSvoltage.

Stimulationisdisabledinorderto

preservepowerforRF

communication.

“OK”Schedulereplacement

oftheStimulator.

Stimulatorbatteryhasreachedthe

ElectiveReplacementIndicator(ERI).

BatteryhasreachedERIvoltage. “OK”Schedulereplacement

oftheStimulator.

StimulatorclockisHH:MM.Doyou

wanttoupdateStimulatorclock?

TheNSinternaltimeisoutofsync

withtheProgrammertime.

“Yes”

“No”



Thestimulatorhasbeensettodefault

values.

TheProgrammerhasencounteredan

NSwithunreadableorinvaliddata.

Parametershavebeensetand

programmedtodefaultvalues.

“OK”Setupdevice

parametersasdesired.

Thestimulatorhasunreadabledata.

Pleasereconnectwithprogrammerin

FCEmodeorcontactyourSpinal

Modulationrepresentative

NShasunreadabledata(suchasTrim

data)

“OK”ContactyourSpinal

Modulation

Representative.

ThestimulatorisinUpgradeMode.

Pleasereconnectwithprogrammerin

FCEmodeorcontactyourSpinal

Modulationrepresentative.

NSinBootmode.“OK”ContactyourSpinal

Modulation

Representative.

Unabletoconnecttostimulator.Make

suretheprogrammerisclosetothe

stimulatorandtryagain.

Can’tconnecttotheNS.“OK”Movetheprogrammer

abovetheStimulatorin

circularmotions.



Errormessagesmaycontainadditionaltroubleshootinginformationsuchas“ErrorCode:04‐

123,BadParameterValue”.ThisisanaidforSpinalModulationengineerstodebugerrors.

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

Spinal Modulation, Incorporated Clinical Programmer LP0014 Rev Draft FCC CProg

Contents

Revised user manual MN-0700

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