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