Axonics 1501 Operating and maintenance manual

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Sacral Neuromodulation System
Clinician Programmer Manual
Model 1501 Clinician Programmer
Rx only

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Axonics®, Axonics Modulation®, Axonics Modulation Technologies®, and Axonics Sacral
Neuromodulation System® are trademarks of Axonics Modulation Technologies, 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
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Introduction .................................................................................................................................................................6
Axonics SNM System for Bowel Control ........................................................................................................................7
Indications................................................................................................................................................................................................7
Precautions ..............................................................................................................................................................................................7
Contraindications .....................................................................................................................................................................................7
Precautions ..................................................................................................................................................................8
Parameter adjustment.............................................................................................................................................................................8
Sensitivity to stimulation .........................................................................................................................................................................8
Programmer interaction with flammable atmospheres..........................................................................................................................8
Programmer interaction with other active implanted devices ...............................................................................................................8
Telemetry signal disruption from EMI .....................................................................................................................................................8
Unintended use .......................................................................................................................................................................................8
Accidental electrode contact...................................................................................................................................................................8
Warnings ......................................................................................................................................................................9
Device Specifications ..................................................................................................................................................10
Operating characteristics........................................................................................................................................................................10
Storage and Usage Environment ............................................................................................................................................................10
Shipping and Storage environment .......................................................................................................................................................11
Maintenance ..........................................................................................................................................................................................11
Handling and disposal ............................................................................................................................................................................11
Wireless Communication .......................................................................................................................................................................12

Table of Contents
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Start Up and General Functions ...................................................................................................................................14
Summary of Clinician Programmer Buttons and Connections ..............................................................................................................15
Turning the Clinician Programmer on and Off.......................................................................................................................................16
Logging-in to the Clinician Programmer ................................................................................................................................................17
Navigating the Home Screen .................................................................................................................................................................18
Description of Battery Level Icons and Charging...................................................................................................................................19
Introduction to Clinician Programmer Prompts ....................................................................................................................................20
Understanding Impedance Values.........................................................................................................................................................21
Controlling Stimulation Amplitude ........................................................................................................................................................22
Test Stimulation During Lead Implantation ...................................................................................................................27
Foramen Needle Test Stimulation .........................................................................................................................................................28
Initial Tined Lead Placement..................................................................................................................................................................30
Define Tined Lead Thresholds ...............................................................................................................................................................32
Programming the Neurostimulator ..............................................................................................................................36
Connecting to a Neurostimulator ..........................................................................................................................................................37
Patient Device Screen Overview............................................................................................................................................................39
Setting up a New Neurostimulator........................................................................................................................................................40
Viewing the Status of a Neurostimulator ..............................................................................................................................................44
Hibernate Mode.....................................................................................................................................................................................49
Programming the Neurostimulator Stimulation Settings......................................................................................................................50
Updating Stimulation Thresholds ..........................................................................................................................................................58
Home Screen Tools ......................................................................................................................................................59
General Clinician Programmer Settings.................................................................................................................................................60

Table of Contents
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User Account Management...................................................................................................................................................................63
Troubleshooting .........................................................................................................................................................64
Issues with the CP display ......................................................................................................................................................................64
Issues Communicating with a Neurostimulator ....................................................................................................................................65
Issues Delivering Stimulation.................................................................................................................................................................66
Impedance Issue During Lead Implant ..................................................................................................................................................69
Impedance Issue with the Neurostimulator ..........................................................................................................................................70
Label Symbols .............................................................................................................................................................71

Introduction
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Introduction
This manual provides information about the Model 1501 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 1101 Neurostimulator
Axonics Model 1201 Tined Lead
Purpose
The CP can provide test stimulation during tined lead implantation and can wirelessly communicate with the
implanted Neurostimulator to check device status and program the device.
Note: The CP is required to implant a tined lead or program a Neurostimulator for chronic SNM therapy. Confirm
the availability and operation of a CP prior to beginning a lead implant procedure.
Note: The Model 1501 Clinician Programmer only communicates with the implanted Neurostimulator (Model 1101).
It does not communicate with the Trial Stimulator (Model 1601). Use the Model 2501 Clinician Programmer to
communicate with the Trial Stimulator and implant a PNE lead or Tined lead for an external trial.
Package Contents
Axonics Model 1501 Clinician Programmer
Power Supply
Product Literature
Caution: Do not sterilize any part of the clinician programmer. Sterilization may damage the
programmer.

Axonics SNM System for Bowel Control
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Axonics SNM System for Bowel Control
Indications
Axonics SNM Therapy for bowel control is indicated for the treatment of chronic fecal incontinence in patients who
have failed or are not candidates for more conservative treatments.
Precautions
Clinician Training
Implanting clinicians should be trained on the implantation and use of the Axonics SNM System.
Prescribing clinicians should be experienced in the diagnosis and treatment of fecal incontinence and
should be trained on the use of the Axonics SNM System.
Use in Specific Populations
The safety and effectiveness of this therapy has not been established for:
Pregnant women
Pediatric use (patients under the age of 18)
Patients with progressive, systemic neurological diseases
Bilateral stimulation
Contraindications
The Axonics SNM System is contraindicated for the following patients
•Patients who have not demonstrated an appropriate response to test stimulation; or
•Patients who are unable to operate the Axonics SNM System.

Precautions
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Precautions
Parameter adjustment – The steps below should be taken to prevent sudden stimulation changes that lead to an
uncomfortable jolting or shocking feeling:
Stimulation parameters should be changed in small increments.
The stimulation amplitude should be allowed to ramp to full amplitude slowly.
Before disconnecting a stimulation cable or turning stimulation on or off, the stimulation amplitude should be
decreased to 0.0 mA.
Sensitivity to stimulation – Some patients, especially those that are very sensitive to stimulation, may be able to sense
the telemetry signals associated with the CP communicating with the Neurostimulator.
Programmer interaction with flammable atmospheres – The CP is not intended to be used in the presence of a
flammable gases, and the consequences of using the CP in such an environment is not known.
Programmer interaction with other active implanted devices – When a patient has a Neurostimulator and another
active implanted device (for example, a pacemaker, defibrillator, or another neurostimulator), the RF signal used to
program any of these devices may reset or reprogram the other devices.
Whenever the settings for these devices are changed, a clinician familiar with each device should check the program
settings of each device before the patient is released (or as soon as possible). Patients should contact their physician
immediately if they experience symptoms that are likely to be related to the devices or their medical condition.
Telemetry signal disruption from EMI – The Neurostimulator should not be programmed near equipment that may
generate electromagnetic interference (EMI) as the equipment may interfere with the CP’s ability to communicate with
the Neurostimulator. If EMI is suspected to be interrupting programming, the CP and the Neurostimulator should be
moved away from the likely source of EMI.
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.

Warnings
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Warnings
⚠Warning: Do not attempt to modify or service this product. If there is an issue with the product, please consult an Axonics
representative.
⚠Warning: Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as
diathermy) should not be used during implantation of the Axonics SNM System or on patients implanted with the Axonics
SNM System. Diathermy can transmit energy through the CP and accessories or the implanted system, potentially causing
tissue damage at the location of the surface or implanted electrodes, resulting in severe injury.

Device Specifications
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Device Specifications
Operating characteristics
Power source: Lithium-ion battery (rechargeable)
External power source: Powerbox EMX30
Input Power: 100 – 240 VAC, 47 – 63 Hz, 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: 14 Hz
Pulse width: 210 μs
*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

Device Specifications
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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 °C to 70 °C
Temperature (long term): 20 °C to 30 °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.
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.

Device Specifications
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Wireless Communication
Radiofrequency telemetry
Model: 1501
IC: 20225-C
FCC ID: 2AEEGC
Quality of Wireless Service:
This device operates in the 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 CP
has to be within 1 meter from the implant for successful communication.
Wireless Security:
Any CP can communicate with a Stimulator. Additional mechanisms exist to ensure the integrity of radio data.
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 General Settings screen.
IC Compliance
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two

Device Specifications
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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 disabled in all intended user screens. Do not plug any devices into this USB 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 auto run executables.
Note: The USB port is for Axonics use only and its functionality is protected.

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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 Connections
• 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

Summary of Clinician Programmer Buttons and Connections
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Summary of Clinician Programmer Buttons and Connections
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 Test Stimulation
⑨Power Input
⑩USB port
The purposes and uses of these buttons and connections
are described throughout this manual.
NOTE: EMG functionality is disabled in this model.
NOTE: USB port is disabled in this model.

Turning the Clinician Programmer On and Off
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Turning the Clinician Programmer on and Off
Turning on the CP
1 • 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) to turn off the CP.

Logging-in to the Clinician Programmer
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Logging-in to the Clinician Programmer
1
2 3 4
• 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.
4
• 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).
5
• 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.

Navigating the Home Screen
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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 Neurostimulator.
1 2 ③CP Settings - Change CP settings, including default
stimulation settings.
3
4 5
6
Additional information about each of these functions is
included in the following sections of this manual.
④,⑤,⑥These buttons are for use by
the Manufacturer only.

Description of Battery Level Icons and Charging
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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 show on
this page are as follows:
①Partially Full to Full (2 to 4 bars)
•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.
②Low
•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.
③Charging
•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 (④). 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.
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.

Introduction to Clinician Programmer Prompts
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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
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 Requires confirmation to proceed in situations where inputs may result in system
performance issue or disruption in the workflow. If applicable, the Progress Prompt
will appear after input.
Progress
Prompt
A momentary display appears to confirm the progress and completion of a
task. No action required.
Error A device issue has occurred, compromising device function. This issue may or
may not be reversible.
CP Failure A serious Clinician Programmer issue has occurred, compromising device
function. The Clinician Programmer will automatically shut down. User may
restart Clinician Programmer to see if issue persists.