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.

7
Start Up and General Functions
Thissectiondescribes the processof startingup theClinicianProgrammer (CP) andprovides instructions onseveral
key CP functions that areencountered in multiple screens when using the CP.
Thefollowing sections include:
Getting Started
•Summary of CP Buttons and Functions
•Turning the CP on and off
•Logging-in to the CP
•Navigatingthe Homescreen
General Functions
•Description of Battery Level Icons and Charging
•Introduction to Clinician Programmer Prompts
•Understanding Impedance Values
•Controlling Stimulation Amplitude

8
Summary of CP Buttons and Functions
The CP has two physical buttons:
1Power Button– turns theCPonand off.
2Stimulation Button – turns teststimulation on and off
(select screens only)
The CPhas a Connector Panel with plugsfor thecables
thatare usedwith the CP. The symbolsontheConnector
Panel indicate which cable should be used with each plug:
3Not used
4Not used
5Not used
6Tined Lead TestStimulation
7Stimulation Ground
8Foramen Needle or PNE Lead TestStimulation
9Power Input
10 USB port
The purposes and uses of these buttons and connections
are described throughout this manual
Note:EMGfunctionalityisnotavailableinthismodeloftheAxonics
ClinicianProgrammer.
Note: TheUSBportis disabledinall screens except, Reports List
Screen(seesection Reports).
1
2
3
4
5
6
7
8 9
3 4 5 6 7 8 9
10

9
Turning the Clinician Programmer On and Off
Turning On the CP
•Pressandholdthepowerbutton ( 1) to turn on the CP.
•TheCPscreen will showthe Axonics logoastheCPstarts up.
•The CP will proceed to the password protected Log-In screen.
Turning Off the CP
•From any CP screen,pressandholdthepowerbutton
(1)toturnofftheCP
1

10
Logging-in to the Clinician Programmer
•WhentheCP is turned on, it will
start-up at the Log-In screen.
•By default, the “ADMIN” user
name will appear on the Log-In
screen ( 1).
•Press “ADMIN” to log in using that
user name.
•Press the down arrow to the
right of the user name to select
a different user name ( 2).There
will notbeadown arrowifno
additional user names exist.
•A short listofnames will appear
when thedown arrowispressed.
•Press auser name to selectitto
log in ( 3).
•More names can be accessed by
scrolling up and downthelistusing
the arrows on theright( 4).
•A keypad will appearwhenauser
name is selected.
•Enter the 4-digit passcode
associatedwith the selecteduser
name to log-in to the CP.
•Press “Cancel” to switch user
names( 5).
Note: TheCPwill automaticallylog-out auser after30minutesof inactivity.

11
Navigating the Home Screen
The Homescreen will appear aftersuccessful log-in to theCP.
The Home screen provides access to themain functions of the
CP, including:
1Lead Placement – Deliver teststimulation during a lead
placement procedure.
2Connect to Patient Device – Check the status of and
program a Stimulator.
3CP Settings - Change CP settings, including default
stimulation settings.
4Reports List-View, save,andmanageCP reports.
Additional information about each of these functions is included
in the following sections of this manual.
5Log out – Returns to the Log-In Screen.
2
1
3
4
5

12
Description of Battery Level Icons and Charging
Determining the CP Battery Level
Thebattery iconshows theCPbattery level. This icon is
always displayed in the bottom leftcorner of thescreen
whenthe CP is on.
The number of bars on the battery icon indicates the CP
battery level, and bars disappear from right-to-left as
battery charge is depleted. The battery levels shown on
this pageareasfollows:
Partially Full to Full (2to4bars)
When 4bars arepresentthebattery
is full ornearly full. At4or3bars,
the batterybars are white.When the
batterydrops to 2 bars, thebars are
yellow indicating less than half the
battery charge is remaining.
Low
When the battery level is low, the
battery displays 1 red bar.
Note:Aprocedure shouldnot be startedwitha lowbatteryto avoid
theCP batterydyingduringtheprocedure.
Twominutes beforetheCPautomatically shuts down
due toacritically low battery, theuserwill beprompted
tochargetheCP. Thisprompt can onlybe disabled by
plugging inandcharging theCP.
Charging
When the device is charging, the
battery icon shows 4 green bars
andalightning bolt.Charging a fully
depleted CP can take up to 6 hours.
How to Charge the CP
TochargetheCP, plugthe
powersupplyintoapower
outlet and into the CP. The
powersupplyplugsinto
theCPat the rightend of
the Connection Panel and
is indicated bythe“Refer to
manual” symbol .
Note: ChargetheCP aftereachuse.Afull batteryshouldlastfor
approximately3-4hours ofuse.Ifmultipleimplantproceduresare
scheduled onasingle day,chargetheCPbetweenproceduresto
ensure thebatterydoesnotrun out.Always keeptheCPpower
supplywiththeCP.
Note: TheCP shouldprovide5ormoreyears ofservice.With
repeatedcharging,theCPbatterymaylosecapacity. NotifyAxonics
if you experience asignificantchangeintheoperatingtimefora
fullycharged CPbattery.

13
Introduction to Clinician Programmer Prompts
Prompts will presentinformation during CP use in order to
confirmuser intentand to provideinformation on actionprogress
and errors. Each prompt presents the followinginformation:
1Prompt type – An icon indicating the general purpose of the
prompt (e.g., progress indicator, error alert)
2Headline – The general topic of the prompt
3Message–Astatementofthereason for the prompt
4Response button(s) – A button or buttons appear for prompts
which requirearesponse from theuser
1
2
3
4
Types of Prompts
An icon will be part of each promptto indicate the purpose of the prompt. Icons include:
Prompt Purpose Prompt Icon
Query     
   
  
Progress
Prompt
    

Error       
reversible.
CP Failure          
        
Programmer to seeif issue persists.

14
Understanding Impedance Values
Impedance values are importantindicators when delivering teststimulation or stimulating with the Stimulator.
The impedance values provided by the CP are icons representing the quality of thecircuit being used to deliver
stimulation.
Impedance can be tested when a button is present. When the button is pressed, the CP will display either:
•A single impedance icon corresponding to theconnection for foramen needlestimulation or PNE lead.
•4 impedance icons, each corresponding to the connection for one of the electrodes on the tined lead.
The impedance icon can have one of 4 states:
Good
The impedance level indicates a good connection and is preferred for stimulation.
OK
The impedance level indicates an acceptableconnection and is allowed for stimulation.
23(1
Bad – Open
The impedance level indicates an open circuit and stimulation is not possible.
6+257
Bad – Short
The impedance level indicates a short circuit and stimulation is not possible.
Note: Seethe manual sections on Troubleshooting forsteps to resolveoutofrange(“Bad”) impedance values.

15
Controlling Stimulation Amplitude
Thestimulation bar ( 1) controls thestimulation amplitude
during teststimulation for lead placement and Stimulator
programming. When available, the stimulation bar is on the right
sideoftheCPscreen. The stimulation barincludes:
2A digital display of thestimulation amplitude level.
•When stimulation is OFF, this display shows in gray the
desired, or programmed, stimulation amplitude.
•When stimulation is ON, this display shows in blue the
output, or delivered, stimulation amplitude.
Note:Forextreme stimulation settings (includinghighamplitude,pulse width,
and/orrate) andimpedancevalues (e.g.,high impedancevalues)the output
stimulationamplitudethat isdeliveredto the patientmay belessthanthe
programmed stimulationamplitude. Increasing the pulse widthin this situation
mayprovide sufficient charge deliveryto obtain the desired stimulation
response. Refer to the table (Stimulation Output Ranges) attheend of this
sectionforasummary of maximum achievable stimulationamplitudes under
different stimulationconditions. Axonics recommends testingalternative
electrodeconfigurations – particularly thosewithlower impedances if
available– to attempt to reduce the stimulation output required to obtain the
desiredstimulationresponse.
3Up arrowand down arrowbuttons to increase and decrease
stimulation amplitudeincrementally.
•Bydefault,the“Variable”settingwill allow foramplitude
changes in 0.05mA increments if theamplitude is
<1.30mA. Atamplitudesabove 1.30mA, thedefault
incremental changeis 0.10mA.
•On the CP Settingsscreen,theincrementofamplitude
change can be changed from the “Variable” to a fixed
incrementof 0.05mA or 0.10mA.
•Incremental stimulation amplitudechanges can bemade
when stimulation is off or on.
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Controlling Stimulation Amplitude
4A slider bar indicates the level of stimulation and can
bemoved up or down tomakelarge changes to the
stimulation amplitude.
Note: Thesliderbarcanonlybeused tochangestimulationamplitude
whenstimulationis off.
5The gray box between the up and down arrows represents
the programmable rangeofstimulation amplitude,
which is 0 to12.5mA. Athigh electrodeimpedances,the
delivered stimulation amplitude may belowerthanthe
programmed amplitude.
6When stimulation is on, the area under the slider bar will
turn dark gray with horizontal blue bars.
7Stimulation may be setto increase amplitude
automatically if “Auto” is selected.
Stimulation amplitude can beadjusted in twomodes: Manual
or Automatic.
Manual Amplitude Adjustment
Manual amplitude adjustmentis the default mode and is
active when“Manual” ( 7) is seen. In themanual amplitude
adjustment mode, stimulation amplitude is changed by
moving the slider bar ( 4) or bypressing theupanddown
arrows ( 3). Stimulation is turnedon bypressingthe
stimulation button ( 8), which lights up when stimulation
is on. When stimulation is on, the amplitude can only be
adjusted using theupanddown arrows. Stimulation is turned
off bypressing thestimulation button ( 8)again.
Note: Forteststimulationduringleadplacementand Stimulator
programming,the stimulationamplitudewill startattheprogrammedlevel
andwill notrampfromzero even iftheRampfeatureisconfigured.
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