Axonics SNM System 2501 User manual

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Sacral Neuromodulation System
Clinician Programmer Manual
Model 2501 Clinician Programmer
Rx only

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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.
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
Purpose of the trial system ...........................................................................................................................................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
Device Specifications ..................................................................................................................................................10
Operating characteristics .......................................................................................................................................................................10
Storage and Usage Environment ...........................................................................................................................................................10
Maintenance ..........................................................................................................................................................................................11
Handling and disposal ............................................................................................................................................................................11
Wireless Communication .......................................................................................................................................................................12
Start Up and General Functions...................................................................................................................................14
Summary of Clinician Programmer Buttons and Connections ..............................................................................................................15
Turning the Clinician Programmer On and Off ......................................................................................................................................16

Table of Contents
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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 .................................................................................................................26
Foramen Needle Test Stimulation .........................................................................................................................................................27
PNE Lead Test Stimulation.....................................................................................................................................................................30
Tined Lead Test Stimulation ..................................................................................................................................................................33
Programming the stimulator .......................................................................................................................................36
Connecting to a stimulator ....................................................................................................................................................................37
Patient Device Screen Overview............................................................................................................................................................39
Setting up a New Stimulator..................................................................................................................................................................40
Viewing the Status of a Stimulator ........................................................................................................................................................43
Resetting the Stimulator........................................................................................................................................................................50
Programming the Stimulator Stimulation Settings................................................................................................................................51
Home Screen Tools ......................................................................................................................................................58
User Account Management...................................................................................................................................................................58
Clinician Programmer Settings...............................................................................................................................................................59
Programming Session Reports...............................................................................................................................................................62
Troubleshooting..........................................................................................................................................................64
Issues with the CP display ......................................................................................................................................................................64

Table of Contents
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Issues Communicating with a Stimulator ..............................................................................................................................................65
Issues delivering stimulation .................................................................................................................................................................66
Impedance Issue during lead implant....................................................................................................................................................69
Impedance Issue with the Stimulator ....................................................................................................................................................70
Label Symbols .............................................................................................................................................................71

Introduction
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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 2201 Tined Lead
Purpose
The CP can provide test stimulation during lead implantation and can wirelessly communicate with the Trial
Stimulator to check device status and program the device.
Note: The CP is required to implant a lead or program a Trial Stimulator for an external trial of SNM. Confirm
the availability and operation of a CP prior to beginning a lead implant procedure.
Note: The Model 2501 Clinician Programmer only communicates with the Trial Stimulator (Model 1601). It
does not communicate with the implanted Neurostimulator (Model 1101). Use the Model 1501 Clinician
Programmer to communicate with the Neurostimulator and to implant a permanent tined lead.
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
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.

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 Stimulator.
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 Stimulator and an active
implanted device (for example, a pacemaker, defibrillator, or another Stimulator), 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 Stimulator 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
Stimulator. If EMI is suspected to be interrupting programming, the CP and the Stimulator 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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⚠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, 0.3 - 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: 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