Axonics SNM System 1401 User manual

Axonics SNM SystemTM
Charging System
Charging System User Manual
Models 1401, 9005, 9008, 9108

2
Axonics® and Axonics SacralNeuromodulation System® are
trademarks of Axonics, Inc., registered or pending
registration in the U.S. and other countries.
Caution: The Axonics Sacral Neuromodulation System
should be used only on the order of a doctor.

3
Contents
Introduction ..............................................................9
Manual Overview .............................................................11
Refer to Your Patient Therapy Guide..................................12
Charging System Components...........................................13

4
Precautions ......................................................................14
Recommended Use and Care ............................................16
How to Use Your Charging System ..........................18
Charger Buttons and Lights ...............................................19
Charger Sounds and Vibrations .........................................22

5
Initial Set-up.....................................................................23
Where to Place the Charger...............................................24
How to Charge.........................................................26
1) Turn the Charger On ..................................................28
2) Attach the Belt..............................................................29

6
3) Place the Charger Over the Stimulator...........................31
4) Complete Charging........................................................35
Troubleshooting...................................................... 37
Troubleshooting Scenarios ................................................39
Additional Information .............................................42

7
Replacement and Disposal................................................43
Care Instructions ..............................................................44
Specifications ...................................................................45
Access Product Manuals Online ........................................51
Axonics Patient Support....................................................53

8
Label Symbols...................................................................54

Introduction

11
Introduction
The Axonics Sacral Neuromodulation (SNM) therapy is
prescribed to relieve the symptoms of urinary and fecal
dysfunction. Patients are given a Charging System to charge
their Stimulator battery.
This manual describes how to use the Charging System.
Axonics recommends you read this manual before using
your Charging System.

Manual Overview
This manual describes how to use your Charging System. The
manual includes:
Overview of Charging System buttons, lights, and functions
Steps for using your Charging System
Troubleshooting Charging System issues
Additional information about the Charging System
If you have issues with your Charging System, ask your doctor
for assistance.

Refer to Your Patient Therapy Guide
Refer to the Patient Therapy Guide that was provided by
your doctor for additional information about your
Axonics SNM System, including:
Indications for Use
Contraindications
System Warnings
System Precautions
Patient Activity Precautions

Charging System Components
Charger
Charges the
Stimulator
Charge Belt
Holds the Charger
over the Stimulator
Dock
Stores and
charges the
Charger
Power Supply
Connects the Dock
to a
power source
Carrier (Packaged separately)
Holds the Charger over the Stimulator
Note: Carriers are packaged separately. Contact your
doctors office or Axonics Customer Support to inquire
about carriers.

Precautions
If you have other active implants (such as a pacemaker), the Charger
may cause issues with such implant(s). Contact your doctor if you
experience issues or have any questions.
Some equipment may generate signals, called Electromagnetic
Interference or EMI, that block the
Charger’s signals to the
Stimulator. If you have issues using
your Charger, move away
from such sources, including
computer monitors, cellular
telephones, and other
electronic equipment.
Do not use the Charger over an open wound. The Charger,
charge belt and carrier are not sterile. Contact with an open
wound could cause an infection.
15

Precautions
Do not use the power supply near water. Use in these
conditions could result in shock or serious injury.
If you experience skin irritation, redness or heating at the
site of charging, do not continue charging.
Do not sit or lie on the Charger during charging as this may
apply unwanted pressure at the charge site. Consult your
doctor if you have irritation or discomfort during charging.
⚠Warning: Do not attempt to modify or service this product. If
there is an issue with the product, please consult your doctor.

Recommended Use and Care
DO
√Develop a habit for charging that fits your schedule (e.g.,
every Sunday while watching your favorite TV show). You
do not need to wait for the Stimulator battery to be low to
charge.
√Store your Charger on the Dock between uses. Keep
the Dock plugged in so the Charger will be ready when
you want to charge.
√Clean your Charger and Dock with a damp, soft cloth
as needed.
√Only use the power supply provided with the Dock.

Recommended Use and Care
DO NOT
хDo not let your Stimulator stay at a low battery level for long
periods of time (e.g., weeks).
хDo not drop the Charger in liquid or clean it with harsh cleaners.
хDo not use the Charger near flammable or explosive gases.
хDo not place the Charger over clothes when charging. It will
take longer to charge.
хDo not use the Charger under a blanket or heavy clothing. This
may cause the charger to heat up.

How to Use Your Charging System
The Charging System allows you to easily and comfortably
recharge your Stimulator battery. When the Charger is
placed on the skin over the implanted Stimulator, the
Charger will charge the Stimulator battery. Charging a low
Stimulator battery typically takes 1 hour depending on the
depth of the Stimulator and how the Charger is placed over the
Stimulator. A Belt or a Carrier can be used to hold the
Charger in place while charging. This section shows you the
Charger’s buttons, lights, and sounds. It also shows you the
ideal placement of your Charger over your Stimulator.
Note: If you notice a change in device performance or when you reach 15
years of implantation, please consult your physician to discuss your
options.

Charger Buttons and Lights
The Charger has a button and two lights that help you
use the Charger.
Power Button
Turns on or off the Charger
Power Light
Shows if the Charger has enough battery
to charge your Stimulator
Error Light
Shows if the Charger has an issue

Charger Button and Lights
1 Power Button
2
Power Light