Axonics Model 2301 User manual

Axonics SNM System®
Remote Control
Modulation
Technologies
Remote Control User Manual
Model 2301
!USA
Rx ONLY

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

3
Contents
3
Introduction ......................................... 5
Manual Overview..................................... 6
Refer to Your Therapy Guides ........................... 7
Remote Control Precautions............................ 8
Recommended Use and Care........................... 9
How to Use Your Remote Control....................... 11
Summary of Buttons and Lights ........................ 12
How Your Remote Control Communicates with
Your Stimulator ................................... 14
Use Scenarios....................................... 15
1) Connect to Your Stimulator ...................... 16
2) View Stimulator Status .......................... 18
3) Turn Down Your Stimulation Level................. 22
4) Turn Up Your Stimulation Level ................... 24

4
Contents
4
5) Turn Your Stimulation Off ........................ 26
6) Turn Your Stimulation On ........................ 28
7) Monitor Charge Status
Permanent Stimulator Only ...................... 30
8) Change Your Stimulation Program
Trial Stimulator Only ........................... 32
9) See a System Error ............................. 34
10) Turn Off Your Remote Control ................... 36
Troubleshooting..................................... 38
Additional Information ............................... 43
Replacement and Disposal ......................... 44
Specifications .................................... 45
Axonics Contact Information ....................... 48
Label Symbols ................................... 49

55
Introduction
The Axonics Sacral Neuromodulation (SNM) therapy is
provided to relieve the symptoms of fecal dysfunction. Patients
are given a Remote Control to monitor the battery status and
settings of their Axonics SNM System.
This manual describes how to use the Remote Control.
Axonics recommends you read this manual before using your
Remote Control.

6
6
Manual Overview
This manual describes the steps for safe use of your Remote
Control. The manual includes:
■Description of Remote Control buttons, indicators and
functions
■Steps for using your Remote Control
■Troubleshooting Remote Control issues
■Additional information about the Remote Control
Note: The Remote Control may behave differently when
communicating with the Trial Stimulator (TS) and the Permanent
Stimulator (PS). This manual will highlight when certain behavior is
specific to the TS or PS. Otherwise both stimulators are referred to
commonly as the Stimulator.

77
Refer to Your Therapy Guides
Refer to the following Therapy Guides which are provided by
your doctor for more information regarding your system:
■Trial System Guide – for more information about the trial
stimulation period
■Patient Therapy Guide – for more information about
permanent SNM therapy

8
8
Remote Control Precautions
■If you have other active implants (such as a pacemaker),
the Remote Control may cause issues with such implant(s).
Contact your doctor if you experience issues or have any
questions.
■If you have cochlear implants, the external portion of these
implants should be kept away from the Remote Control. This
will help avoid and/or reduce unwanted audible clicks.
■Some equipment may generate signals, called
Electromagnetic Interference or EMI. EMI can block the
Remote Control’s signals to the Stimulator. If you have issues
using your Remote Control, move away from such sources.
This includes computer monitors, cellular telephones and
other electronic equipment.
Warning: Do not attempt to modify or service this product. If there is
an issue with the product, please consult your doctor.

99
Recommended Use and Care
DO
9Carry your Remote Control with you at all times in case you
need to adjust your stimulation or check the battery status
of your Stimulator.
9If you need to store your Remote Control, put it in a cool,
dry place away from direct heat and light.
9Clean your Remote Control with a damp, soft cloth as
needed.
9Bring your Remote Control to all visits with your healthcare
provider.

10
10
Recommended Use and Care
DO NOT
✕Do not drop the Remote Control in liquid or clean it with
harsh cleaners.
✕Do not drop the Remote Control or mishandle it in a way
that causes damage.
✕Do not use the Remote Control near flammable or
explosive gases.
✕Do not allow other people to use your Remote Control.

1111
How to Use Your Remote Control
The Remote Control allows you to monitor your stimulation
level and the need to recharge the PS. This section describes
how to use your Remote Control to:
■Monitor Stimulator battery status and stimulation level
■Turn up or turn down your stimulation level
■Turn your stimulation on and off
■Monitor charging of your Stimulator (PS only)
■Change your stimulation program (TS only)
■Receive notice of errors in your Remote Control or
Stimulator
Note: Do not make stimulation changes regularly. Your doctor should
change your stimulation settings if needed. Axonics recommends you
only change your stimulation if you experience discomfort

12
12
Summary of Buttons and Lights
Stimulation
Level
Connect
System Error
Up
Down
Stimulator
Battery Status
Active
Program

1313
Summary of Buttons and Lights
Stimulation Level Shows the strength of stimulation.
Up Turn up stimulation level or Turn on
stimulation to default level.
Connect Connect or disconnect the Remote Control
to the Stimulator.
Down Turn down stimulation level or Turn off
stimulation.
Active Program Shows which stimulation program is active.
System Error Shows there is an error in the Remote
Control or Stimulator.
Stimulator
Battery Status
For TS, shows how long until the battery is
depleted.
For PS, shows if the battery needs charging.
Note: For a detailed description of the lights see the section View
Stimulator status

14
14
How Your Remote Control Communicates
with Your Stimulator
The Remote Control sends and receives
signals to and from the Stimulator. Your
Remote Control must be near the
Stimulator to send and receive signals.
Only the Remote Control given to you
by your doctor can send and receive
signals to and from your Stimulator.
To use your Remote Control, hold it
comfortably in front of you. The
Remote Control should be held on the
same side of the body as the Stimulator.

1515
Use Scenarios
The following pages show how to use
your Remote Control to:
1) Connect to your Stimulator.
2) View Stimulator status.
3) Turn down your stimulation level.
4) Turn up your stimulation level.
5) Turn your stimulation off.
6) Turn your stimulation on.
7) Monitor battery charge status (PS only).
8) Change your stimulation program (TS only).
9) See a system error.
10) Turn off your Remote Control.
Note: If you have
issues using your
Remote Control,
please refer to the
Troubleshooting
section of this manual.
For more help please
contact your doctor.

16
16
1) Connect to Your Stimulator
1 2 3

1717
1) Connect to Your Stimulator
1Hold the Remote Control on the same side of your body as
the Stimulator. Press the “Connect” button on the center of
the Remote Control.
2The stimulation level lights will flash. Flashing lights mean the
Remote Control is trying to connect to the Stimulator. It may
take up to 25 seconds for the Remote Control to connect to
the Stimulator.
3Watch for the stimulation level lights to stop flashing and the
stimulator battery light to turn on. This means the Remote
Control is communicating with the Stimulator. (If no light is
visible connection has failed. See Troubleshooting.)
Note: The most common issue is not having your Remote Control close
enough to the Stimulator. If your initial connection attempt fails, move
the Remote Control closer to the Stimulator and retry.
Note: Moving the Remote Control while connected to the Stimulator
may result in loss of communication.

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2) View Stimulator Status
Stimulation
Level
Stimulator
Battery Status
Active
Program

1919
2) View Stimulator Status
Stimulator battery status lights
Solid green: Stimulator battery will last for 4 or more days
Flashing green (PS only): Stimulator battery is charging
Solid orange: Stimulator battery will last for 2 to 4 days
Flashing orange: Stimulator battery will last for 2 days or
less
Stimulation Level lights
No stimulation
Default level set by your doctor
Maximum level

20
2) View Stimulator Status
Active Program
Program 1 is active
Program 2 is active (TS only)