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Axonics SNM System® Remote Control Remote Control User Manual ...
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Axonics SNM System® Remote Control EN User Manual Model 2301 ...
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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 ...
Summary of buttons and lights .............. Error! Bookmark not defined. How your Remote Control communicates with your Stimulator .... Error! Bookmark not defined. 1) Connect to your Stimulator ............ Error! Bookmark not defined. 2) View Stimulator Status............... Error! Bookmark not defined. 3) Turn Down your stimulator level .......... Error! Bookmark not defined. 4) Turn up your stimulator level ............ Error! Bookmark not defined. 5) Turn your stimulation off ............ Error! Bookmark not defined. 6) Turn your stimulation on ............ Error! Bookmark not defined. 7) Monitor charge status – Permanent Stimulator only .... Error! Bookmark not defined. 8) Switch the active program – Trial Stimulator only .... Error! Bookmark not defined. 9) See a system error .............. Error! Bookmark not defined. 10) Turn off your Remote Control .......... Error! Bookmark not defined. Troubleshooting .................... Error! Bookmark not defined. Additional Information ................. Error! Bookmark not defined. Replacement and disposal ............. Error! Bookmark not defined. Specifications .......................... 7 Axonics contact information ...................... 9 Label Symbols .......................... 10 ...
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. Otherwise both stimulators are referred to commonly as the Stimulator. ...
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 7.1 x 3.8 x 1.6 cm Weight 60g Expected Battery 5 years Life* Communication Radiofrequency telemetry Model: 2301 FCC ID: 2AEEGP IC: 20225‐P Quality of Wireless Service: ...
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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 license‐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 Remote Control not authorized by Axonics could void FCC and IC certification and negate your authority to use the product . ...
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. Call: +1‐949‐396‐6320 Hours: M‐F, 8:00 am ‐ 5:00 pm (Pacific Time) ...
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. This symbol means that the device fully complies with AIMD Directive 90/385/EEC (Notified Body reviewed) and RED 2014/53/EU (self‐certified) IC Industry Canada certification number Classified by CSA with respect to safety 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) ...
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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 2019. Axonics Modulation Technologies, Inc. 110‐0044‐001r Draft ...
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