Axonics SNM 1401 User manual

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AxonicsSNMSystem®ChargingSystem
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ChargingSystemUserManual
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ChargingSystemManual
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UserManual
Model1401,9005,9008
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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TherapyGuides.......................................................................Error!Bookmarknotdefined.
ChargingSystemComponents......................................................................Error!Bookmarknotdefined.
Precautions....................................................................................................Error!Bookmarknotdefined.
Recommendeduseandcare.........................................................................Error!Bookmarknotdefined.
HowtouseyourChargingSystem................................................................Error!Bookmarknotdefined.
ChargerButtonandLights............................................................................Error!Bookmarknotdefined.
ChargerSoundsandVibrations....................................................................Error!Bookmarknotdefined.
InitialSet‐up..................................................................................................Error!Bookmarknotdefined.
AdditionalInformation.................................................................................Error!Bookmarknotdefined.
Replacementanddisposal........................................Error!Bookmarknotdefined.
CareInstructions......................................................Error!Bookmarknotdefined.
Specifications..........................................................................................................7
AxonicsPatientSupport.......................................................................................10
LabelSymbols.......................................................................................................11
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Introduction
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TheAxonicsSacralNeuromodulation(SNM)therapyisprescribedtorelievethesymptoms
ofurinarydysfunction.PatientsaregivenaChargingSystemtocharge  theirStimulator
battery.
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ThismanualdescribeshowtousetheChargingSystem. 
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AxonicsrecommendsyoureadthismanualbeforeusingyourChargingSystem.
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Manualoverview
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ThismanualdescribeshowtouseyourChargingSystem.Themanualincludes:
OverviewofChargingSystembutton,lightsandfunctions
StepsforusingyourChargingSystem
TroubleshootingChargingSystemissues
AdditionalinformationabouttheChargingSystem
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IfyouhaveissueswithyourChargingSystem,askyourdoctorforassistance.
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Specifications
EnvironmentalSpecifications–Charger,Dock,PowerSupply,CarrierandBelt 
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ChargerSpecifications
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93mmx24.4mm
WeightApproximately175g
ExpectedBattery
Life*
5years

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CommunicationRadiofrequencytelemetry
Model:1401,IC:20225‐D,FCCID:2AEEGD
QualityofWirelessService:
Thisdeviceoperateson402‐405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Chargerhastobewithin1meterfromthe
implantforsuccessfulcommunication.
WirelessSecurity:
AnyChargercancommunicatewithyourStimulator.Additional
mechanismsexisttoensuretheintegrityofradiodata.
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*Expectedbatterylifebasedontypicalandworstcaseusescenario
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DockSpecifications
ItemSpecification
PowersourcePower
b
ox EMX30
InputPower100‐240VAC,47‐63Hz,15V,2A
Size19.5mmx93.0mm
WeightApproximately150g
ExpectedUsableLife*5years
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CarrierandBeltSpecifications 
ItemSpecification
Carrier
MaterialPolypropylene
AdhesiveMedicalgradesiliconeadhesive
Belt
Material–BandBreathoprene
Material–Ring
Polypropylene 

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LengthRegular:112cm(44inches)
Extended:152cm(60inches)
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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licence‐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.’’.
Note:ChangesandmodificationstotheChargingSystemarenotauthorizedbyAxonicsand
couldvoidFCCandICcertificationandnegateyourauthoritytousetheproduct.
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AxonicsPatientSupport
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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
SymbolDescription
ProductSerialNumber
ProductLotNumber
Manufacturer
ProductModelNumber
ManufacturingDate
IEC60601‐1/EN60601‐1,Type BF Equipment
Nonionizingelectromagnetic radiation
ForUSAaudiencesonly:
Caution:USFederallawrestrictsthisdeviceforsaleby
 orontheorderofaphysician
Refertoinstructionsforuse (Consult accompanying documents)
Temperaturelimitation
Humiditylimitation
Pressurelimitation
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ClassifiedbyCSAwithrespect to safety
Followinstructionsforuse(operatormanual)
Donotuseifpackageisdamaged
AuthorizedrepresentativeintheEuropeancommunity
IP24Protectionfromtheamountofdustandsplashingwaterthatwouldinterferewiththe
operationofthedevice.
IP22Protectionfromtheamountofdustandverticallydrippingwaterthatwouldinterfere
withtheoperationofthedevice.
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ICIndustryCanadacertificationnumber
Handwashonly
Donottumbledry
ConformitéEuropéenne(European Conformity):2016. This symbol meansthatthedevice
fullycomplieswithAIMDDirective
90/385/EEC(NotifiedBodyreviewed)andRED2014/53/EU(self‐certified)
Poweron/offbutton
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ThisdevicecomplieswithallapplicableRadioSpectrumManagement’s(RSM)andAustralian
CommunicationsandMediaAuthority(ACMA)regulatoryarrangementsandapplicableelectricalequipment
safety.

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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2018.
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AxonicsModulationTechnologies,Inc.
110‐0044‐001rDRAFT