Axonics SNM System 2501 User manual

Sacral Neuromodulaon System
Clinician Programmer Manual
Model 2501 Clinician Programmer
!USA Rx ONLY

Axonics®, Axonics Sacral Neuromodulation System® and r-SNM® are trademarks of
Axonics, Inc., registered or pending registration in the U.S. and other countries.
Refer to the appropriateclinician manuals for additional information on theAxonics SNM System,
including contraindications, warnings, precautions, adverse events, individualization of treatment,
patientselection, and implantprocedures.

Table of Contents
Introduction .................................. 1
Indications, Warnings, and Precautions
Purpose of the trialsystem
Precautions .................................. 3
Device Specifications .......................... 4
Operating Characteristics
StorageandUsageEnvironment
Maintenance
Handling and Disposal
Wireless Communication
Start Up and General Functions .................. 7
Summary of CP Buttons and Functions
Turning the Clinician Programmer On and Off
Logging-in to the Clinician Programmer
NavigatingtheHomeScreen
Description of Battery Level Icons and Charging
Introduction to Clinician Programmer Prompts
Understanding Impedance Values
Controlling Stimulation Amplitude
Test Stimulation During Lead Implantation ........ 19
Foramen NeedleTestStimulation
PNE Lead TestStimulation
Tined Lead TestStimulation
Connecting toaStimulator
Programming the External Trial Stimulator ........ 32
Setting Up a New Trial Stimulator
Viewingthe Status ofaTrial Stimulator
Resetting the TrialStimulator
Programming theTrial Stimulator
Programming the Implanted Neurostimulator ..... 51
Programming the Implanted Neurostimulator ..... 52
Setting Up a New Neurostimulator
Viewingthe Status ofaNeurostimulator
Hibernate the Neurostimulator
Programming the Neurostimulator
Updating Stimulation Thresholds
Checking for MRI Readiness
Home Screen Tools............................ 75
Clinician Programmer Settings
Reports
Troubleshooting .............................. 82
Issues with theCPDisplay
Issues Communicating with a Stimulator
Issues DeliveringStimulation
Impedance Issue During Lead Implant
Impedance Issuewith the Stimulator
Label Symbols................................ 88

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1
Introduction
This manual provides information about the Model 2501 Axonics Sacral Neuromodulation (SNM) System Clinician
Programmer (CP). The CPcan beused during implantation and programming ofthe following Axonics SNMSystem
components:
•Axonics Model 1601 Trial Stimulator
•Axonics Model 1901 PNE Lead
•Axonics Model 1201, 2201 Tined Lead
•Axonics Model 1101 Neurostimulator
Purpose
The CP can provideteststimulation during tined lead and PNE lead implantation and can wirelessly communicate
withtheStimulator tocheckdevicestatus andprogram the device.The Trial Stimulator is usedfortrial SNMtherapy
whereas the Neurostimulator is used for chronic SNM therapy.
Note: TheCP is requiredto implant alead(tinedleadorPNE lead)orprogramaStimulator. Confirmtheavailabilityand operationofaCP
priorto beginningalead implantprocedure.
Package Contents
•Axonics Model 2501 Clinician Programmer
•Power Supply
•Product Literature
Caution: Do notsterilize any part of theclinician programmer. Sterilization may damage the programmer.

2
Introduction
Indications, Warnings, and Precautions
•Refer to Indications for Use insertfor indications and contraindications
•Refer to Information for Prescribers booklet for warnings, precautions, adverse events, patient selection and clinical
summary.
•Refer to MRI Physician Guidelines for MRI specific conditions and contraindications.
Purpose of the trial system
The Axonics SNMTrial System is usedfor a testperiod to evaluateifa subjectshould betreatedwiththe Axonics SNM
System.

3
Precautions
Unintended Use – TheCP is intendedforuseduring implantation and programming ofthe Axonics SNMSystem. It
should onlybeusedwithmanufacturerprovidedaccessories. Do notuse the CP for stimulation or other purposesnot
described in this manual. Unintended use can resultin user or patientinjury.
Accidental Electrode Contact – Avoid accidental contact between connected but unapplied electrodes and other
conductive parts, including thoseconnected to protectiveearth.

4
Device Specifications
Operating Characteristics
Power source: Lithium-ion battery (rechargeable)
External power source: Powerbox EMX30
Input Power: 100 – 240 VAC, 47–63Hz, 0.3 - 0.6 A
OutputPower: 15 V, 2 A
Battery life*: 3 hours per charge; 5-years expected
lifetime
Dimensions: 257 mm(w)x246mm(h) x22 mm (d)
Weight:1125g
Material:
•Housing: Polycarbonate and ABS resin blend
•Buttons: Silicone with polyurethane coating
•Screen: Touch-screen, LCD display, 1280 x 800 pixels
CP TestStimulation Output:
•Maximum Amplitude: 12.5 mA
•Frequency:5Hz or14 Hz
•   
*Note: Batterylifemayvarydependingonfrequencyofuse
Storage and Usage Environment
Usageenvironment
The following lists the appropriate temperature,
humidity, and pressurecondition for use of theAxonics
CP:
•Temperature:5°Cto 35 °C
•Humidity: 15% to 95%
•Pressure: 70 kPa to 106 kPa
Shipping and Storage Environment
The following lists the appropriate temperature,
humidity, and pressurecondition for shipping and
storage of the Axonics CP:
•Temperature (short term: 3 days): -25 oCto70o
C
•Temperature (long term): 20 oCto30o
C
•Humidity(short term: 3 days): 15% to95%
•Humidity(long term):30% to85%
•Pressure (short term: 3 days): 57 kPa to 106 kPa
•Pressure (long term): 70 kPa to 106 kPa
If the CPis exposed to extreme temperatures,it may be
permanentlydamaged andshouldnotbeused, even
if ithas returnedtoatemperaturethat is within the
specified operating range.

5
Device Specifications
Maintenance
Atleast once a year, the CP should be inspected for visible damage and should becharged and powered on to confirm
the Log-Inscreen is still accessible.Significantphysical damage oraninabilityto power onthedeviceshouldbe
reported to the manufacturerandthedeviceshouldnotbeused.
Handling and Disposal
•Cleaning: TheCP can be wiped witha cloth lightlymoistenedwith water. No other cleaning agents shouldbe used.
•Replacement: If the CP is lost or not working, contact Axonics.
•Disposal:Donot incineratetheCP as thebattery may explode.IftheCP is no longerneeded, contact Axonics to
return thedevice.
Wireless Communication
•Radiofrequency telemetry
•Model: 2501
•IC: 20225-C
•FCC ID: 2AEEGC
•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ENETSI 302-537 andUSA: FCC 47 CFR Part 95;
Subpart I.TheCPhas to be within 1 meterfrom the Stimulator for successful communication.
•Wireless Security:
•Any CP can communicate withaStimulator. Additionalmechanismsexist toensure theintegrityofradio data.

6
Device Specifications
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.
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.
Note: FCCComplianceinformationcanbeaccessedontheCP inthe
Clinician Programmer Settingsscreen.
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.
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ClinicianProgrammerare
notauthorizedbyAxonics and could voidFCCandIC certification
andnegatetheuser’sauthorityto usetheproduct.
Note: TheUSBporton ClinicianProgrammer isusedforthepurpose
of transferring(copying)thesessionreportstoaUSBflashdrive.Do
notpluganyotherdevicesintothisport.Someexamplesofdevices
that are prohibitedare:USBwithWiFi orBluetooth,USBData
TransferCable,USB mouse,USBkeyboard,orUSBflashdriveswith
autorun executables.
Note: TheUSBportis disabledinall screens except Reports List
screen(seesection Reports).Inthisscreenthesession reports
canbetransferredtoaUSBflashdrive.IntheReports List screen,
thestimulationfunctions arenotaccessible andare disabled. The
reportsaretransferred(copied) inPDF format.
Note:A Wirelessconnectionthrough theUSBportis not an intended
use. This wireless functionality is disabled in the Clinician Programmer.