AxonicsSNMSystemRemoteControl RemoteControlUserManual AxonicsSNMSystemRemoteControl EN UserManual Model2301 Axonics,AxonicsModulation,AxonicsModulationTechnologies,AxonicsSacral NeuromodulationSystemandrSNMaretrademarksofAxonicsModulation Technologies,Inc.,registeredorpendingregistrationintheU.S.andothercountries. Caution:TheAxonicsSacralNeuromodulationSystemshouldbeusedonlyontheorderofa doctor Contents Introduction..................................................................................................................................................5 Manualoverview..........................................................................................................................................6 RefertoyourPatientTherapyGuide............................................................Error!Bookmarknotdefined. RemoteControlprecautions.........................................................................Error!Bookmarknotdefined. Recommendeduseandcare.........................................................................Error!Bookmarknotdefined. HowtouseyourRemoteControl.................................................................Error!Bookmarknotdefined. Summaryofbuttonsandlights.....................................................................Error!Bookmarknotdefined. HowyourRemoteControlcommunicateswithyourStimulator................Error!Bookmarknotdefined. 1)ConnecttoyourStimulator.......................................................Error!Bookmarknotdefined. 2)ViewStimulatorStatus...............................................................Error!Bookmarknotdefined. 3)TurnDownyourstimulatorlevel...............................................Error!Bookmarknotdefined. 4)Turnupyourstimulatorlevel....................................................Error!Bookmarknotdefined. 5)Turnyourstimulationoff...........................................................Error!Bookmarknotdefined. 6)Turnyourstimulationon...........................................................Error!Bookmarknotdefined. 7)MonitorchargestatusPermanentStimulatoronly................Error!Bookmarknotdefined. 8)SwitchtheactiveprogramTrialStimulatoronly....................Error!Bookmarknotdefined. 9)Seeasystemerror.....................................................................Error!Bookmarknotdefined. 10)TurnoffyourRemoteControl.................................................Error!Bookmarknotdefined. Troubleshooting............................................................................................Error!Bookmarknotdefined. AdditionalInformation.................................................................................Error!Bookmarknotdefined. Replacementanddisposal.............................................................Error!Bookmarknotdefined. Specifications................................................................................................................................7 Axonicscontactinformation.........................................................................................................9 LabelSymbols..............................................................................................................................10 Introduction TheAxonicsSacralNeuromodulation(SNM)therapyisprovidedtorelieve thesymptomsofurinaryfecaldysfunction.PatientsaregivenaRemote ControltomonitorthebatterystatusandsettingsoftheirAxonicsSNM System. ThismanualdescribeshowtousetheRemoteControl. AxonicsrecommendsyoureadthismanualbeforeusingyourRemote Control. Manualoverview ThismanualdescribesthestepsforsafeuseofyourRemoteControl.The manualincludes:
DescriptionofRemoteControlbuttons,indicatorsandfunctions StepsforusingyourRemoteControl TroubleshootingRemoteControlissues AdditionalinformationabouttheRemoteControl Note:TheRemoteControlmaybehavedifferentlywhencommunicatingwith theTrialStimulator(TS)andthePermanentStimulator(PS).Thismanualwill highlightwhencertainbehaviorisspecifictotheTSorPS.Otherwiseboth stimulatorsarereferredtocommonlyastheStimulator. Specifications Item OperatingConditions Specification Temperature 5C40C(41F104F) Pressure Humidity 70kPa106kPa 15%95%
Storage&ShipmentConditionsShortTerm(3daysorless) Temperature Pressure 25C70C(13F158F) 57kPa106kPa Humidity Storage&ShipmentConditionsLongTerm(over3days) 15%95%
Temperature 20C30C(68F86F) Pressure Humidity 70kPa106kPa 30%85%
Powersource Lithiumionbattery(nonrechargeable) Size 7.1x3.8x1.6cm 60g 5years Weight ExpectedBattery Life*
Communication Radiofrequencytelemetry Model:2301 FCCID:2AEEGP IC:20225P QualityofWirelessService:
Thisdeviceoperatesinthe401406MHzfrequencyandthe maximumeffectiveradiatedpowerisbelowthelimitof25W ERP/EIRPasspecifiedinEU:ENETSI301839andUSA:FCC47CFR Part95;SubpartI. TheRemoteControlhastobewithin1meterfromtheStimulator forsuccessfulcommunication. WirelessSecurity:
TheRemoteControlisuniquelypairedtoaspecificStimulator. Additionalmechanismsexisttoensuretheintegrityofradiodata.
*Expectedbatterylifebasedontypicalusescenario Specifications FCCCompliance Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemust acceptanyinterferencereceived,includinginterferencethatmaycauseundesired operation. ThistransmitterisauthorizedbyruleundertheMedicalDeviceRadioCommunicationService
(inpart95oftheFCCRules)andmustnotcauseharmfulinterferencetostationsoperatingin the400.150406.000MHzbandintheMeteorologicalAids(i.e.,transmittersandreceivers usedtocommunicateweatherdata),theMeteorologicalSatellite,ortheEarthExploration SatelliteServicesandmustacceptinterferencethatmaybecausedbysuchstations,including interferencethatmaycauseundesiredoperation.Thistransmittershallbeusedonlyin accordancewiththeFCCRulesgoverningtheMedicalDeviceRadiocommunicationService. Analoganddigitalvoicecommunicationsareprohibited.Althoughthistransmitterhasbeen approvedbytheFederalCommunicationsCommission,thereisnoguaranteethatitwillnot receiveinterferenceorthatanyparticulartransmissionfromthistransmitterwillbefree frominterference. ICCompliance ThisdevicecomplieswithIndustryCanadalicenseexemptRSSstandard(s).Operationissubject tothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevice mustacceptanyinterference,includinginterferencethatmaycauseundesiredoperationof thisdevice. FCCandICCompliance Thisdevicemaynotinterferewithstationsoperatinginthe400.150406.000MHzbandinthe MeteorologicalAids,MeteorologicalSatellite,andEarthExplorationSatelliteServicesandmust acceptanyinterferencereceived,includinginterferencethatmaycauseundesiredoperation. Note:ChangesandmodificationstotheRemoteControlnotauthorizedbyAxonicscouldvoid FCCandICcertificationandnegateyourauthoritytousetheproduct. Axonicscontactinformation Pleasecontactyourdoctorifyouhavequestionsaboutyourhealthorthe AxonicsSNMtherapy. AxonicsPatientSupport Axonics,locatedinIrvine,CA(USA)canhelpanswerquestionsorconcerns aboutyourAxonicsSNMtherapy.PleasenotethatAxonicscannotdiscussor commentonyourmedicalcondition. Call:+19493966320 Hours:MF,8:00am5:00pm(PacificTime) LabelSymbols Symbol Description RemoteControl RemoteControlUserManual(thisdocument) ProductSerialNumber Manufacturer ProductModelNumber ManufacturingDate IEC606011/EN606011, Type BF Equipment Nonionizingelectromagnetic radiation ConformitEuropenne(European Conformity): 2018. ThissymbolmeansthatthedevicefullycomplieswithAIMDDirective90/385/EEC
(NotifiedBodyreviewed)andRED2014/53/EU(selfcertified) IC IndustryCanadacertification number ClassifiedbyCSAwithrespect to safety ForUSAaudiencesonly Caution:USFederallawrestrictsthisdeviceforsalebyorontheorderofa physician Refertoinstructionsforuse(Consultaccompanyingdocuments) Temperaturelimitation Humiditylimitation Pressurelimitation Donotuseifpackageisdamaged AuthorizedrepresentativeintheEuropeancommunity IP57 Protectionfromtheamountofdustthatwouldinterferewiththeoperationofthe device. Protectionagainsttemporaryimmersioninwater. ThisdevicecomplieswithallapplicableAustralianCommunicationsandMedia Authority(ACMA)regulatoryarrangementsandapplicableelectricalequipment safetyrequirements. AxonicsModulationTechnologies, Inc. 26TechnologyDrive Irvine,CA92618(USA) www.axonicsmodulation.com Tel.+19493966320 Fax+19493966321 HealthLink EuropeServicesBV DeTweeling2022 5215MCsHertogenbosch TheNetherlands AllRightsReserved.Copyright2019. AxonicsModulationTechnologies,Inc. 1100044001rDraft