AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 13
WIRELESS COMMUNICATION
Model: 4101
FCC ID: 2AEEGT
IC: 20225-T
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 Neurostimulator are not authorized by Axonics could void FCC and IC certification 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 effective radiated power of the Neurostimulator
communication 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 Remote Control or Clinician Programmer must be within 1 meter from the implant for successful
communication.
Wireless Security
The Neurostimulator 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 Neurostimulator. Additional mechanisms exist to ensure the
integrity of radio data.
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