Axonics SNM System® Remote Control Remote Control User Manual
Axonics SNM System® Remote Control EN User Manual Model 2301
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.
Contents Introduction .................................................................................................................................................. 5 Manual overview.......................................................................................................................................... 6 Refer to your Patient Therapy Guide............................................................ Error! Bookmark not defined. Remote Control precautions .................................
Introduction The Axonics Sacral Neuromodulation (SNM) therapy is provided to relieve the symptoms of urinary 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.
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.
Specifications Item Specification Operating Conditions Temperature 5°C ‐ 40°C (41°F – 104°F) Pressure 70kPa – 106kPa Humidity 15% ‐ 95% Storage & Shipment Conditions – Short Term (3 days or less) Temperature Pressure ‐25°C ‐ 70°C (‐13°F – 158°F) 57kPa – 106kPa Humidity 15% ‐ 95% Storage & Shipment Conditions – Long Term (over 3 days) Temperature 20°C ‐ 30°C (68°F – 86°F) Pressure 70kPa – 106kPa Humidity 30% ‐ 85% Power source Lithium‐ion battery (non‐rechargeable) Size 7.1 x 3.8 x 1.
Specifications FCC Compliance This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This transmitter is authorized by rule under the Medical Device Radio Communication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.
Axonics contact information Please contact your doctor if you have questions about your health or the Axonics SNM therapy. Axonics Patient Support Axonics, located in Irvine, CA (USA) can help answer questions or concerns about your Axonics SNM therapy. Please note that Axonics cannot discuss or comment on your medical condition.
Label Symbols Symbol Description Remote Control Remote Control User Manual (this document) Product Serial Number Manufacturer Product Model Number Manufacturing Date IEC 60601‐1/EN60601‐1, Type BF Equipment Non ionizing electromagnetic radiation Conformité Européenne (European Conformity): 2018.
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 2019. Axonics Modulation Technologies, Inc.
