Axonics 1101 User manual

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Sacral Neuromodulation System
Neurostimulator Implant Manual
Model 1101 Neurostimulator
Rx only
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.

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Axonics Modulation Technologies, Inc.
26 Technology Drive
Irvine, CA 92618 (USA)
www.axonicsmodulation.com
Tel. [phone]
Fax [phone]

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LABEL SYMBOLS
This section explains the symbols found on the product and
packaging.
Symbol
Description
Axonics Neurostimulator
Axonics Torque Wrench
Neurostimulator default
waveform with 14 Hz
frequency, 0 mA amplitude
and 210 µs pulse width
Neurostimulator
default electrode
configuration:
Electrode 0:
negative (-)
Electrode 1: Off (0)
Electrode 2: Off (0)
Electrode 3:
Positive (+)
Case: Off (0)
Product Serial Number

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Symbol
Description
Manufacturer
Product Model Number
Manufacturing Date
Non ionizing
electromagnetic radiation
Conformité Européenne
(European Conformity).
This symbol means that the
device fully complies with
AIMD Directive 90/385/EEC
(Notified Body reviewed)
and RED 2014/53/EU (self-
certified)
Refer to instructions for
use (Consult accompanying
documents)
Temperature limitation
Humidity limitation
Pressure limitation

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Symbol
Description
Do not reuse
Sterilized using Ethylene
oxide
Use by
Do not use if package is
damaged
Do not re-sterilize
Authorized representative
in the European
community
Open here
For USA audiences only
Caution: U.S. Federal law
restricts this device for sale
by or on the order of a
physician
󱛻󱛼󱛽
Warning / Caution
Product Literature

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Symbol
Description
Magnetic Resonance (MR)
Conditional
IC Industry Canada
certification number
This device complies with
all applicable Australian
Communications and
Media Authority (ACMA)
regulatory arrangements
and electrical equipment
safety requirements
FCC ID US Federal
Communications
Commission device
identification

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TABLE OF CONTENTS
LABEL SYMBOLS....................................................... 3
TABLE OF CONTENTS ............................................. 7
INTRODUCTION........................................................ 9
INDICATIONS, WARNINGS, AND
PRECAUTIONS........................................................... 9
DEVICE DESCRIPTION ..........................................10
Package Contents............................................................. 10
System Registration Form and Patient Identification
Card ................................................................................. 11
STORAGE AND USAGE ..........................................12
Sterilization...................................................................... 13
SPECIFICATIONS ....................................................14

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X-RAY IDENTIFICATION ......................................16
NEUROSTIMULATOR IMPLANT
PROCEDURE.............................................................17
Procedure Supplies........................................................... 17
Neurostimulator Preparation ........................................... 17
Creating the Neurostimulator Pocket................................ 18
Connecting the Lead to the Neurostimulator .................... 19
Implanting the Neurostimulator ....................................... 22
Completing the Implant Procedure ................................... 24
Post-Surgery Treatment ................................................... 24
Replacing the Neurostimulator......................................... 24
WIRELESS COMMUNICATION ............................26
CUSTOMER SERVICE .............................................28

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INTRODUCTION
This manual provides information about the Axonics Sacral
Neuromodulation (SNM) System Neurostimulator (Model
1101), which is a part of the Axonics SNM System. The
Neurostimulator is connected to the Axonics Tined Lead
(Model 1201 or 2201).
Indications, Warnings, and
Precautions
•Refer to Indications for Use insert for indications and
contraindications
•Refer to Information for Prescribers booklet for warnings,
precautions, adverse events, patient selection and clinical
summary.
•Refer to MRI Physician Guidelines for MRI specific conditions
and contraindications.

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DEVICE DESCRIPTION
The Axonics Neurostimulator (Figure 1) is part of the
Axonics SNM System. The Neurostimulator is a
programmable device that is connected to the Axonics
tined lead, which conducts stimulation pulses to the sacral
nerve.
Package Contents
The Neurostimulator package contains the following:
• Neurostimulator
• Torque wrench
• System registration form
• Patient identification card
• Neurostimulator Implant Manual (this document)
The contents of the inner package are STERILE. The
contents of the Neurostimulator package are intended for
single use only.
Figure 1: Axonics Neurostimulator.