Axonics SNM System 2301 User manual

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AxonicsSNMSystem®RemoteControl
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RemoteControlUserManual
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AxonicsSNMSystem®RemoteControl
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UserManual
Model2301
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EN

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Axonics®,AxonicsModulation®,AxonicsModulationTechnologies®,AxonicsSacral
NeuromodulationSystem®andr‐SNM®aretrademarksofAxonicsModulation
Technologies,Inc.,registeredorpending  registrationintheU.S.andothercountries.
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Caution:TheAxonicsSacralNeuromodulationSystemshouldbeusedonlyontheorderofa
doctor
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Contents
Introduction..................................................................................................................................................5
Manualoverview..........................................................................................................................................6
RefertoyourPatientTherapyGuide............................................................Error!Bookmarknotdefined.
RemoteControlprecautions.........................................................................Error!Bookmarknotdefined.
Recommendeduseandcare.........................................................................Error!Bookmarknotdefined.
HowtouseyourRemoteControl.................................................................Error!Bookmarknotdefined.
Summaryofbuttonsandlights.....................................................................Error!Bookmarknotdefined.
HowyourRemoteControlcommunicateswithyourStimulator................Error!Bookmarknotdefined.
1)ConnecttoyourStimulator.......................................................Error!Bookmarknotdefined.
2)ViewStimulatorStatus...............................................................Error!Bookmarknotdefined.
3)TurnDownyourstimulatorlevel...............................................Error!Bookmarknotdefined.
4)Turnupyourstimulatorlevel....................................................Error!Bookmarknotdefined.
5)Turnyourstimulationoff...........................................................Error!Bookmarknotdefined.
6)Turnyourstimulationon...........................................................Error!Bookmarknotdefined.
7)Monitorchargestatus–PermanentStimulatoronly................Error!Bookmarknotdefined.
8)Switchtheactiveprogram–TrialStimulatoronly....................Error!Bookmarknotdefined.
9)Seeasystemerror.....................................................................Error!Bookmarknotdefined.
10)TurnoffyourRemoteControl.................................................Error!Bookmarknotdefined.
Troubleshooting............................................................................................Error!Bookmarknotdefined.
AdditionalInformation.................................................................................Error!Bookmarknotdefined.
Replacementanddisposal.............................................................Error!Bookmarknotdefined.
Specifications................................................................................................................................7
Axonicscontactinformation.........................................................................................................9
LabelSymbols..............................................................................................................................10
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Introduction
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TheAxonicsSacralNeuromodulation(SNM)therapyisprovidedtorelieve
thesymptomsofurinaryfecaldysfunction.Patientsare
 givenaRemote
Controltomonitorthebattery
 statusandsettingsoftheirAxonicsSNM
System.
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ThismanualdescribeshowtousetheRemote
 Control.
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AxonicsrecommendsyoureadthismanualbeforeusingyourRemote
Control.
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Manualoverview
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ThismanualdescribesthestepsforsafeuseofyourRemoteControl.The
manualincludes:
 DescriptionofRemoteControlbuttons,  indicatorsandfunctions
 StepsforusingyourRemoteControl
 TroubleshootingRemoteControlissues
 AdditionalinformationabouttheRemoteControl
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Note:TheRemoteControlmaybehavedifferentlywhencommunicatingwith
theTrialStimulator(TS)andthePermanentStimulator(PS).Thismanualwill
highlightwhencertainbehaviorisspecifictotheTSorPS.Otherwiseboth
stimulatorsarereferredtocommonlyastheStimulator.
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Specifications
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Item Specification
OperatingConditions
Temperature 5°C‐40°C(41°F–104°F)
Pressure 70kPa–106kPa
Humidity 15%‐95%
Storage&ShipmentConditions–ShortTerm(3daysorless)
Temperature ‐25°C‐70°C(‐13°F–158°F)
Pressure 57kPa–106kPa
Humidity 15%‐95%
Storage&ShipmentConditions–LongTerm(over3days)
Temperature 20°C‐30°C(68°F–86°F)
Pressure 70kPa–106kPa
Humidity 30%‐85%
Powersource Lithium‐ionbattery(non‐rechargeable)
Size 7.1x3.8x1.6cm
Weight 60g
ExpectedBattery
Life*
5years
Communication Radiofrequencytelemetry
Model:2301
FCCID:2AEEGP
IC:20225‐P
QualityofWirelessService:
Thisdeviceoperatesinthe401‐406MHzfrequencyandthe
maximumeffectiveradiatedpowerisbelowthelimitof25µW
ERP/EIRPasspecifiedinEU:ENETSI301839andUSA:FCC47CFR
Part95;SubpartI.
TheRemoteControlhastobewithin1meterfromtheStimulator
forsuccessfulcommunication.
WirelessSecurity:
TheRemoteControlisuniquelypairedtoaspecificStimulator.
Additionalmechanismsexisttoensuretheintegrityofradiodata.
*Expectedbatterylifebasedontypicalusescenario

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Specifications
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FCCCompliance
Thisdevicecomplieswithpart15oftheFCCRules.Operationissubjecttothefollowingtwo
conditions:(1)Thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemust
accept  anyinterferencereceived,includinginterferencethatmaycauseundesired
operation.
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ThistransmitterisauthorizedbyruleundertheMedicalDeviceRadioCommunicationService 
(inpart95oftheFCCRules)andmustnotcauseharmfulinterferencetostationsoperatingin
the400.150–406.000MHzbandintheMeteorologicalAids(i.e.,transmittersandreceivers
used  tocommunicateweatherdata),theMeteorologicalSatellite,ortheEarthExploration
Satellite
 Servicesandmustacceptinterferencethatmaybecausedbysuchstations,including 
interferencethatmaycauseundesiredoperation.Thistransmittershallbeusedonlyin
accordancewiththeFCCRulesgoverningtheMedicalDeviceRadiocommunicationService.
Analoganddigitalvoicecommunicationsareprohibited.Althoughthistransmitterhasbeen
approvedbytheFederalCommunicationsCommission,thereisnoguaranteethatitwillnot 
receiveinterferenceorthatanyparticulartransmissionfromthistransmitterwillbefree
from  interference.
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ICCompliance
ThisdevicecomplieswithIndustryCanadalicense‐exemptRSSstandard(s).Operationissubject 
tothefollowingtwoconditions:(1)thisdevicemaynotcauseinterference,and(2)thisdevice 
mustacceptanyinterference,includinginterferencethatmaycauseundesiredoperationof
thisdevice.
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FCCandICCompliance
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.
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Note:ChangesandmodificationstotheRemoteControlnotauthorizedbyAxonicscouldvoid
FCCandICcertificationandnegateyourauthoritytousetheproduct.
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Axonicscontactinformation
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Pleasecontactyourdoctorifyouhave
 questionsaboutyourhealthorthe
AxonicsSNMtherapy.
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AxonicsPatientSupport
Axonics,locatedinIrvine,CA(USA)canhelpanswerquestionsorconcerns
aboutyour
 AxonicsSNMtherapy.PleasenotethatAxonicscannotdiscussor
commentonyourmedicalcondition.
Call:+1‐949‐396‐6320
 Hours:M‐F,8:00am‐5:00pm(PacificTime)
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LabelSymbols
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SymbolDescription
RemoteControl
RemoteControlUserManual(thisdocument)
ProductSerialNumber
Manufacturer
ProductModelNumber
ManufacturingDate
IEC60601‐1/EN60601‐1, Type BF Equipment
Nonionizingelectromagnetic radiation
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ConformitéEuropéenne(European Conformity): 2018.
ThissymbolmeansthatthedevicefullycomplieswithAIMDDirective90/385/EEC
(NotifiedBodyreviewed)andRED2014/53/EU(self‐certified)
IC IndustryCanadacertification number
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ClassifiedbyCSAwithrespect to safety
ForUSAaudiencesonly
Caution:USFederallawrestrictsthisdeviceforsalebyorontheorderofa
physician
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Refertoinstructionsforuse(Consultaccompanyingdocuments)
Temperaturelimitation
Humiditylimitation
Pressurelimitation
Donotuseifpackageisdamaged
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AuthorizedrepresentativeintheEuropeancommunity
IP57 Protectionfromtheamountofdustthatwouldinterferewiththeoperationofthe
device.
Protectionagainsttemporaryimmersioninwater.
ThisdevicecomplieswithallapplicableAustralianCommunicationsandMedia
Authority(ACMA)regulatoryarrangementsandapplicableelectricalequipment
safetyrequirements.
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AxonicsModulationTechnologies, Inc.
26TechnologyDrive
Irvine,CA92618(USA)
www.axonicsmodulation.com
Tel.+1‐949‐396‐6320
Fax+1‐949‐396‐6321
HealthLink EuropeServicesBV
DeTweeling20‐22
5215MC’s‐Hertogenbosch
TheNetherlands
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AllRightsReserved.Copyright2019.
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AxonicsModulationTechnologies,Inc.
110‐0044‐001rDraft