Sacral Neuromodulation System Trial Stimulator Manual Model 1601 Rx only English Trial Stimulator Manual 1
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.
Table of contents TABLE OF CONTENTS ..................................................................................................................................................... 3 INTRODUCTION................................................................................................................................................................ 4 PURPOSE OF THE TRIAL SYSTEM .........................................................................................................................
INTRODUCTION This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Trial Stimulator (Model 1601), which is a part of the Axonics SNM Trial System. The Trial Stimulator (TS) is used to provide temporary electrical stimulation to the S3 or S4 sacral nerve. There are two types of trials for which the TS is used. For a basic trial, the TS connects to a Peripheral Nerve Evaluation (PNE) lead to deliver temporary electrical stimulation.
Storage and Usage Environment Component packaging –Do not use the component if any of the following have occurred: The storage package has been damaged, pierced, or altered. In this case, sterility cannot be guaranteed and infection may occur. The component itself shows any signs of damage. The component may not function properly. The use‐by date has expired. In this case, component performance cannot be guaranteed.
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 Do not reuse IP24 Protection from the amount of dust and splashing water that would interfere with the operation of the device. Do not use if package is damaged Authorized representative in the European community For USA audiences only Caution: U.S.
WIRELESS COMMUNICATION Model: 1601 FCC ID: 2AEEGE IC: 20225‐E FCC Compliance This device complies with part 15 of the FCC Rules.
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.
