User Manual

WIRELESS COMMUNICATION
Model: 5101
FCC ID: 2AEEGS
IC: 20225-S
FCC Compliance
This device complies with part 15 of the FCC Rules. Operaon is subject to the following two condions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operaon
This transmier is authorized by rule under the Medical Device Radio communicaon Service (in part 95 of the FCC Rules) and must not cause
harmful interference to staons operang in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmiers and receivers used to
communicate weather data), the Meteorological Satellite, or the Earth Exploraon Satellite Services and must accept interference that may be caused
by such staons, including interference that may cause undesired operaon.
This transmier shall be used only in accordance with the FCC Rules governing the Medical Device Radio Communicaon Service. Analog and digital
voice communicaons are prohibited. Although this transmier has been approved by the Federal Communicaons Commission, there is no guarantee
that it will not receive interference or that any parcular transmission from this transmier will be free from interference.
IC Compliance
This device complies with Industry Canada license-exempt RSS standard(s). Operaon is subject to the following two condions: (1) this device may not
cause interference, and (2) this device must accept any interference, including interference that may cause undesired operaon of this device.
FCC and IC Compliance
This device may not interfere with staons operang in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth
Exploraon Satellite Services and must accept any interference received, including interference that may cause undesired operaon.
Note: Changes and modicaons to the Neurosmulator are not authorized by Axonics could void FCC and IC cercaon and negate the user’s
authority to use the product.
Quality of Wireless Service
This device operates in the 402-405 MHz frequency and the maximum eecve radiated power of the Neurosmulator communicaon is below the
limit of 25 µW ERP/EIRP as specied in EU: EN ETSI 301-839 and USA: FCC 47 CFR Part 95; Subpart I. The Remote Control or Clinician Programmer must
be within 1 meter from the implant for successful communicaon.
Wireless Security
The Neurosmulator can only communicate with a single Remote Control that is paired to it using the Clinician Programmer. Any Axonics Clinician
Programmer can communicate with a Neurosmulator. Addional mechanisms exist to ensure the integrity of radio data.
CUSTOMER SERVICE
For quesons regarding the Axonics SNM System, call our Customer Support Center toll-free at [phone].
Addional informaon and product manuals can be found at our website: www.axonics.com
2022-12
All Rights Reserved. Copyright 2022.
Axonics, Inc.
110-0290-001 Rev A