Axonics SNM System 1401 User manual

Modulation
Technologies
Charging System User Manual
Ladesystem-Benutzerhandbuch
Manuel d’utilisation du système
de chargement
Sistema de recarga
Manuale d’uso del sistema di ricarica
Gebruikershandleiding voor het
oplaadsysteem
Brukerhåndbok for ladesystem
!USA Rx ONLY
Axonics SNM System®
Charging System

Languages
English .............................................................................. 1
Deutsch .......................................................................... 39
Francais .......................................................................... 77
Espanol......................................................................... 115
Italiano ......................................................................... 153
Nederlands ................................................................... 191
Norsk ............................................................................ 229
EN
DE
FR
ES
IT
NL
NO

1
Modulation
Technologies
User Manual
Models 1401, 9005, 9008
EN
!USA Rx ONLY
Axonics SNM System® Charging System

2
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.
Caution: The Axonics Sacral Neuromodulation System should be
used only on the order of a doctor.

3
Contents
Introduction........................................................................................ 5
Manual Overview.......................................................................... 7
Refer to Your Patient Therapy Guide............................................. 8
Charging System Components ...................................................... 9
Precautions ................................................................................. 10
Recommended Use and Care...................................................... 11
How to Use Your Charging System ................................................... 13
Charger Buttons and Lights......................................................... 14
Charger Sounds and Vibrations................................................... 16
Initial Set-up................................................................................ 17
Where to Place the Charger........................................................ 18
How to Charge .................................................................................. 19
1) Turn the Charger On ............................................................... 20
2) Attach the Belt........................................................................ 21
3) Place the Charger Over the Stimulator................................... 22
4) Complete Charging ................................................................. 23
Troubleshooting................................................................................ 24
Troubleshooting Scenarios.......................................................... 25

4
Contents
Additional information..................................................................... 28
Replacement and Disposal.......................................................... 29
Care Instructions......................................................................... 30
Specifications.............................................................................. 31
Axonics Patient Support.............................................................. 35
Label Symbols ............................................................................. 36

5
Introduction

6
The Axonics Sacral Neuromodulation (SNM) therapy is provided 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.

7
Manual Overview
This manual describes how to use your Charging System.
The manual includes:
■Overview of Charging System buons, lights, and funcons
■Steps for using your Charging System
■Troubleshoong Charging System issues
■Addional informaon about the Charging System
If you have issues with your Charging System, ask your doctor for
assistance.

8
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

9
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
doctor’s office or Axonics Customer Support to inquire
about carriers.

10
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.
■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.

11
Recommended Use and Care
DO
9Develop 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.
9Store your Charger on the Dock between uses. Keep the Dock
plugged in so the Charger will be ready when you want to charge.
9Clean your Charger and Dock with a damp, soft cloth as needed.
9Only use the power supply provided with the Dock.

12
Recommended Use and Care
✕Do not let your Stimulator stay at a low battery level for long
periods of time (e.g., weeks).
✕Do not drop the Charger in liquid or clean it with harsh cleaners.
✕Do not use the Charger near flammable or explosive gases.
✕Do not place the Charger over clothes when charging. It will take
longer to charge.
✕Do not use the Charger under a blanket or heavy clothing. This
may cause the charger to heat up.
DO NOT

13
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.

14
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
1Power Button Power Light
2

15
Charger Button and Lights
1. The power button can be pressed to turn the Charger on and off.
When ON, the power light will come on.
2. The power light will be
■Green: this means you can fully charge the Stimulator.
■Solid Orange: this means you may not be able to fully charge
the Stimulator. If you need to recharge the Stimulator, you
should charge your Charger first.
■Flashing Orange: this means you need to charge the Charger.
■Red: this means there is an error. Turn the Charger off then
back on. If the red light is still on, call your doctor and ask for a
new Charger.

16
Charger Sounds and Vibrations
What you hear or feel: What it means:
One long tone Charger is over the Stimulator and
charging has started.
3 beeps + vibration
(repeats)
Charging has been interrupted and is
not complete.
Three rising tones Stimulator battery is fully charged.