X 1101 user manual

SacralNeuromodulationSystem NeurostimulatorImplantManual Model1101Neurostimulator Rxonly Axonics,AxonicsModulation,AxonicsModulation TechnologiesandAxonicsSacralNeuromodulation SystemaretrademarksofAxonicsModulation Technologies,Inc.,registeredorpendingregistrationinthe U.S.andothercountries. EnglishNeurostimulatorImplantManual 1 Table of contents TABLE OF CONTENTS ............................................. 2 INTRODUCTION ........................................................ 6 AXONICS SNM THERAPY FOR URINARY CONTROL ... ERROR! BOOKMARK NOT DEFINED. Indications...............................Error!Bookmarknotdefined. Precautions..............................Error!Bookmarknotdefined. Cliniciantraining....................Error!Bookmarknotdefined. Useinspecificpopulations....Error!Bookmarknotdefined. CONTRAINDICATIONS ...... ERROR! BOOKMARK NOT DEFINED. WARNINGS . ERROR! BOOKMARK NOT DEFINED. Diathermy................................Error!Bookmarknotdefined. MagneticResonanceImaging(MRI).......Error!Bookmarknot EnglishNeurostimulatorImplantManual 2 defined. Electromagneticinterference(EMI).......Error!Bookmarknot defined. CaseDamage............................Error!Bookmarknotdefined. Effectsonotherimplanteddevices........Error!Bookmarknot defined. PRECAUTIONS .............. ERROR! BOOKMARK NOT DEFINED. Clinicianprogramming..............Error!Bookmarknotdefined. Patientactivities......................Error!Bookmarknotdefined. PatientprogrammingandRemoteControl..Error!Bookmark notdefined. StorageandUsageEnvironment.........................................7 Sterilization..............................Error!Bookmarknotdefined. Systemimplant........................Error!Bookmarknotdefined. INDIVIDUALIZATION OF TREATMENT . ERROR!

BOOKMARK NOT DEFINED. 3 ADVERSE EVENTS ....... ERROR! BOOKMARK NOT DEFINED. PATIENT COUNSELING INFORMATION ERROR!

BOOKMARK NOT DEFINED. COMPONENT DISPOSAL .... ERROR! BOOKMARK NOT DEFINED. DEVICE DESCRIPTIONERROR! BOOKMARK NOT DEFINED. Figure1:AxonicsNeurostimulator..........Error!Bookmarknot defined. Packagecontents.....................Error!Bookmarknotdefined. SystemregistrationformandPatientidentification card.........................................Error!Bookmarknotdefined. SPECIFICATIONS ......... ERROR! BOOKMARK NOT DEFINED. XRAY IDENTIFICATION .... ERROR! BOOKMARK NOT DEFINED. 4 Proceduresupplies...................Error!Bookmarknotdefined. NeurostimulatorPreparation...Error!Bookmarknotdefined. CreatingtheNeurostimulatorpocket.....Error!Bookmarknot defined. ConnectingtheleadtotheNeurostimulatorError!Bookmark notdefined. ImplantingtheNeurostimulatorError!Bookmarknotdefined. Completingtheimplantprocedure........Error!Bookmarknot defined. Postsurgerytreatment............Error!Bookmarknotdefined. ReplacingtheNeurostimulator.Error!Bookmarknotdefined. LABEL SYMBOLS ....................................................... 8 WIRLESS COMMUNICATION ............................... 12 5 INTRODUCTION ThismanualprovidesinformationabouttheAxonicsSacral Neuromodulation(SNM)SystemNeurostimulator(Model 1101),whichisapartoftheAxonicsSNMSystem.The NeurostimulatorisconnectedtotheAxonicstinedlead

(Model1201or2201). EnglishNeurostimulatorImplantManual 6 Storage and Usage Environment ComponentpackagingAnycomponentthathasbeen compromisedinanywayshouldnotbeimplanted.Donot implantthecomponentifanyofthefollowinghave occurred:

Thestoragepackageorsterilepackhasbeen damaged,pierced,oraltered,assterilitycannotbe guaranteed,whichmayleadtoinfection. Thecomponentitselfshowsanysignsofdamage.The componentmaynotfunctionproperly. Theusebydatehasexpired.Inthiscase,component sterilitycannotbeguaranteedandinfectionmay occur. Thesterilecomponentwasdroppedontoanon sterilesurface.Inthiscase,thesterilitycannotbe guaranteedandinfectionmayoccur. Usageenvironment:

Thefollowingliststheappropriatetemperature,humidity, andpressureusageconditionsforuseofthe Neurostimulator:

Temperature:20Cto45C Pressure:TheNeurostimulatorshouldfunctionatup to10m(33feet)underwater(200kPa)andat altitudesupto3000m(10,000feet)associatedwith activitieslikehikingandskydiving(aslowas70kPa) ShippingandStorageenvironment:

Thefollowingliststheappropriatetemperature,humidity, andpressureconditionsforshippingandstoringthe Neurostimulator:

Temperature(shortterm:3days):10oCto55oC EnglishNeurostimulatorImplantManual 7 Temperature(longterm):20oCto30oC Humidity(shortterm:3days):15%to95%

Humidity(longterm):30%to85%

Pressure(shortterm):57kPato106kPa Pressure(longterm):70kPato106kPa IftheNeurostimulatorwasstoredattemperaturesoutside ofthisrange,itshouldnotbeuseduntilithasreturnedto theoperatingtemperaturerange. LABEL SYMBOLS Thissectionexplainsthesymbolsfoundontheproductand packaging. Symbol Description AxonicsNeurostimulator AxonicsTorqueWrench Neurostimulatordefaultwaveform with14Hzfrequency,0mA amplitudeand210spulsewidth 8 Neurostimulatordefaultelectrode configuration:

Electrode0:negative() Electrode1:Off(0) Electrode2:Off(0) Electrode3:Positive(+) Case:Off(0) ProductSerialNumber Manufacturer ProductModelNumber ManufacturingDate Nonionizingelectromagnetic radiation ConformitEuropenne (European Conformity).Thissymbolmeans thatthedevicefullycomplieswith AIMDDirective90/385/EEC

(NotifiedBodyreviewed)andRED 2014/53/EU(selfcertified) Refertoinstructionsforuse

(Consultaccompanying documents) Temperaturelimitation 9 Humiditylimitation Pressurelimitation Donotreuse SterilizedusingEthyleneoxide Useby Donotuseifpackageisdamaged Donotresterilize Authorizedrepresentativeinthe Europeancommunity Openhere ForUSAaudiencesonly Caution:U.S.Federallawrestricts thisdeviceforsalebyoronthe orderofaphysician

Warning/Caution ProductLiterature MagneticResonance(MR) Conditional 10 IC IndustryCanadacertification number Thisdevicecomplieswithall applicableRadioSpectrum Managements(RSM)and AustralianCommunicationsand MediaAuthority(ACMA) regulatoryarrangementsand applicableelectricalequipment safetyrequirements 11 WIRLESS COMMUNICATION Model:1101 FCCID:2AEEGX IC:20225X FCCCompliance Thisdevicecomplieswithpart15oftheFCCRules.Operationis subjecttothefollowingtwoconditions:

(1)Thisdevicemaynotcauseharmfulinterference,and

(2)Thisdevicemustacceptanyinterferencereceived,including interferencethatmaycauseundesiredoperation ThistransmitterisauthorizedbyruleundertheMedical DeviceRadiocommunicationService(inpart95oftheFCC Rules)andmustnotcauseharmfulinterferencetostations operatinginthe400.150406.000MHzbandin theMeteorologicalAids(i.e.,transmittersandreceiversused tocommunicateweatherdata),theMeteorological Satellite,ortheEarthExplorationSatelliteServicesandmust acceptinterferencethatmaybecaused bysuchstations,includinginterferencethatmaycause undesiredoperation. ThistransmittershallbeusedonlyinaccordancewiththeFCC RulesgoverningtheMedicalDeviceRadiocommunication Service.Analoganddigitalvoicecommunicationsare prohibited.Althoughthistransmitterhasbeenapprovedby theFederalCommunicationsCommission,thereisno guaranteethatitwillnotreceiveinterferenceorthatany particulartransmissionfromthistransmitterwillbefreefrom interference. ICCompliance ThisdevicecomplieswithIndustryCanadalicenceexemptRSS standard(s).Operationissubjecttothefollowingtwo conditions:(1)thisdevicemaynotcauseinterference,and(2) 12 thisdevicemustacceptanyinterference,including interferencethatmaycauseundesiredoperationofthis device. FCCandICCompliance Thisdevicemaynotinterferewithstationsoperatinginthe 400.150406.000MHzbandintheMeteorologicalAids, MeteorologicalSatellite,andEarth ExplorationSatelliteServicesandmustacceptany interferencereceived,includinginterferencethatmaycause undesiredoperation. Note:ChangesandmodificationstotheNeurostimulatorare notauthorizedbyAxonicscouldvoidFCCandICcertification andnegatetheusersauthoritytousetheproduct. QualityofWirelessService:Thisdeviceoperatesinthe402 405MHzfrequencyandthemaximumeffectiveradiated poweroftheNeurostimulatorcommunicationisbelowthe limitof25WERP/EIRPasspecifiedinEU:ENETSI301839 andUSA:FCC47CFRPart95;SubpartI.TheRemoteControl, ClinicianProgrammer,orChargerhavetobewithin1meter fromtheimplantforsuccessfulcommunication. WirelessSecurity:TheNeurostimulatorcanonly communicatewithasingleRemoteControlthatispairedtoit usingtheClinicianProgrammer.AnyAxonicsClinician ProgrammerorChargercancommunicatewitha Neurostimulator.Additionalmechanismsexisttoensurethe integrityofradiodata. 13 AxonicsModulationTechnologies,Inc. 26TechnologyDrive Irvine,CA92618(USA) www.axonicsmodulation.com Tel.+1(949)3966320 Fax+1(949)3966321 HealthLinkEuropeServicesBV DeTweeling2022 5215MCsHertogenbosch TheNetherlands AllRightsReserved.Copyright2018. AxonicsModulationTechnologies,Inc. 1100043001r DRAFT 14