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Related Manuals for Axonics SNM 1401
Summary of Contents for Axonics SNM 1401
- Page 1 Axonics SNM System® Charging System Charging System User Manual ...
- Page 2 Charging System Manual EN User Manual Model 1401, 9005, 9008 ...
- Page 3 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. Caution: The Axonics Sacral Neuromodulation System should be used only on the order of a doctor ...
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Page 4: Table Of Contents
Precautions .................... Error! Bookmark not defined. Recommended use and care ................. Error! Bookmark not defined. How to use your Charging System .............. Error! Bookmark not defined. Charger Button and Lights ................ Error! Bookmark not defined. Charger Sounds and Vibrations .............. Error! Bookmark not defined. Initial Set‐up .................... Error! Bookmark not defined. Additional Information ................. Error! Bookmark not defined. Replacement and disposal ........ E rror! Bookmark not defined. Care Instructions ............ E rror! Bookmark not defined. Specifications ...................... 7 Axonics Patient Support .................. 1 0 Label Symbols ....................... 1 1 ... -
Page 5: Introduction
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. ... -
Page 6: Manual Overview
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. ... -
Page 7: Specifications
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 ‐25°C ‐ 70°C (‐13°F – 158°F) Pressure 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 93 mm x 24.4 mm Weight Approximately 175 g Expected Battery 5 years Life* ... - Page 8 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. Additional mechanisms exist to ensure the integrity of radio data. . * Expected battery life based on typical and worst case use scenario Dock Specifications Item Specification Power source Powerbox EMX30 Input Power 100‐240 VAC, 47‐63 Hz, 15V, 2A Size 19.5 mm x 93.0 mm Weight Approximately 150 g Expected Usable Life* 5 years Carrier and Belt Specifications Item Specification Carrier ...
- Page 9 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. 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 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radio Communication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. IC Compliance This device complies with Industry Canada licence‐exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) 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.’’. Note: Changes and modifications to the Charging System are not authorized by Axonics and could void FCC and IC certification and negate your authority to use the product. ...
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Page 10: Axonics Patient Support
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. Call: +1‐949‐396‐6320 Hours: M‐F, 8:00 am ‐ 5:00 pm (Pacific Time) ... -
Page 11: Label Symbols
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 use (operator manual) Do not use if package is damaged Authorized representative in the European community Protection from the amount of dust and splashing water that would interfere with the IP24 operation of the device. ... - Page 12 HealthLink Europe Services BV Axonics Modulation Technologies, Inc. De Tweeling 20‐22 26 Technology Drive 5215 MC ’s ‐ Hertogenbosch Irvine, CA 92618 (USA) The Netherlands www.axonicsmodulation.com Tel. +1‐949‐396‐6320 Fax +1‐949‐396‐6321 All Rights Reserved. Copyright 2018. Axonics Modulation Technologies, Inc. 110‐0044‐001r DRAFT ...
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