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.
Table of contents TABLE OF CONTENTS ............................................. 2 INTRODUCTION........................................................ 6 AXONICS SNM THERAPY FOR URINARY CONTROL ... ERROR! BOOKMARK NOT DEFINED. Indications ............................... Error! Bookmark not defined. Precautions .............................. Error! Bookmark not defined. Clinician training .................... Error! Bookmark not defined. Use in specific populations .... Error! Bookmark not defined.
defined. Electromagnetic interference (EMI) ....... Error! Bookmark not defined. Case Damage............................ Error! Bookmark not defined. Effects on other implanted devices ........ Error! Bookmark not defined. PRECAUTIONS.............. ERROR! BOOKMARK NOT DEFINED. Clinician programming.............. Error! Bookmark not defined. Patient activities ...................... Error! Bookmark not defined. Patient programming and Remote Control .. Error! Bookmark not defined.
ADVERSE EVENTS ....... ERROR! BOOKMARK NOT DEFINED. PATIENT COUNSELING INFORMATION ERROR! BOOKMARK NOT DEFINED. COMPONENT DISPOSAL .... ERROR! BOOKMARK NOT DEFINED. DEVICE DESCRIPTIONERROR! BOOKMARK NOT DEFINED. Figure 1: Axonics Neurostimulator. ......... Error! Bookmark not defined. Package contents ..................... Error! Bookmark not defined. System registration form and Patient identification card ......................................... Error! Bookmark not defined. SPECIFICATIONS .........
Procedure supplies ................... Error! Bookmark not defined. Neurostimulator Preparation ... Error! Bookmark not defined. Creating the Neurostimulator pocket..... Error! Bookmark not defined. Connecting the lead to the Neurostimulator Error! Bookmark not defined. Implanting the NeurostimulatorError! Bookmark not defined. Completing the implant procedure ........ Error! Bookmark not defined. Post‐surgery treatment ............ Error! Bookmark not defined. Replacing the Neurostimulator .
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).
Storage and Usage Environment Component packaging – Any component that has been compromised in any way should not be implanted. Do not implant the component if any of the following have occurred: The storage package or sterile pack has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection. The component itself shows any signs of damage. The component may not function properly. The use‐by date has expired.
Temperature (long term): 20 oC to 30 oC Humidity (short term: 3 days): 15% to 95% Humidity (long term): 30% to 85% Pressure (short term): 57 kPa to 106 kPa Pressure (long term): 70 kPa to 106 kPa If the Neurostimulator was stored at temperatures outside of this range, it should not be used until it has returned to the operating temperature range. LABEL SYMBOLS This section explains the symbols found on the product and packaging.
Neurostimulator default electrode configuration: Electrode 0: negative (‐) Electrode 1: Off (0) Electrode 2: Off (0) Electrode 3: Positive (+) Case: Off (0) Product Serial Number Manufacturer Product Model Number Manufacturing Date Non ionizing electromagnetic radiation Conformité Européenne (European Conformity).
Humidity limitation Pressure limitation 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.
IC Industry Canada certification number This device complies with all applicable Radio Spectrum Management’s (RSM) and Australian Communications and Media Authority (ACMA) regulatory arrangements and applicable electrical equipment safety requirements 11
WIRLESS COMMUNICATION Model: 1101 FCC ID: 2AEEGX IC: 20225‐X FCC Compliance This device complies with part 15 of the FCC Rules.
this device must accept any interference, including interference that may cause undesired operation of this device. FCC and IC Compliance This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.
Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonicsmodulation.com Tel. +1‐(949) 396‐6320 Fax +1‐(949) 396‐6321 HealthLink Europe Services BV De Tweeling 20‐22 5215 MC ’s‐Hertogenbosch The Netherlands All Rights Reserved. Copyright 2018. Axonics Modulation Technologies, Inc.
