Axonics SNM System® Charging System Charging System User Manual
Charging System Manual EN User Manual Model 1401, 9005, 9008
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 Therapy Guides ....................................................................... Error! Bookmark not defined. Charging System Components ............................
Introduction The Axonics Sacral Neuromodulation (SNM) therapy is prescribed to relieve the symptoms of urinary dysfunction. Patients are given a Charging System to charge their Stimulator battery. This manual describes how to use the Charging System. Axonics recommends you read this manual before using your Charging System.
Manual overview This manual describes how to use your Charging System. The manual includes: Overview of Charging System button, lights and functions Steps for using your Charging System Troubleshooting Charging System issues Additional information about the Charging System If you have issues with your Charging System, ask your doctor for assistance.
Specifications Environmental Specifications – Charger, Dock, Power Supply, Carrier and Belt Charger 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
Communication Radiofrequency telemetry Model: 1401, IC: 20225‐D, FCC ID: 2AEEGD Quality of Wireless Service: This device operates on 402‐405 MHz frequency and the maximum effective radiated power is below the limit of 25 µW ERP/EIRP as specified in EU: EN ETSI 301‐839 and USA: FCC 47 CFR Part 95; Subpart I. The Charger has to be within 1 meter from the implant for successful communication. Wireless Security: Any Charger can communicate with your Stimulator.
Length Regular: 112 cm (44 inches) Extended: 152 cm (60 inches) 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.
Axonics Patient Support 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 Product Serial Number Product Lot Number Manufacturer Product Model Number Manufacturing Date IEC 60601‐1/EN60601‐1, Type BF Equipment Non ionizing electromagnetic radiation For USA audiences only: Caution: US Federal law restricts this device for sale by or on the order of a physician Refer to instructions for use (Consult accompanying documents) Temperature limitation Humidity limitation Pressure limitation Classified by CSA with respect to safety Follow instructions for
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.
