Axonics 4101 Recharge-Free Neurostimulator User Manual

Axonics 4101 Recharge-Free Neurostimulator

Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., registered or pending registration in the U.S. and other countries.

LABEL SYMBOLS

This section explains the symbols found on the product and packaging.

INTRODUCTION

This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Neurostimulator (Model 4101), which is a part of the Axonics SNM System. The Neurostimulator is connected to the Axonics Tined Lead (Model 1201 or 2201).

STORAGE AND USAGE ENVIRONMENT

Component Packaging

Any component that has been compromised in any way should not be implanted; this includes the re-use of non-reusable product. Do not implant the component if any of the following have occurred:

• The storage package or sterile pack has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection.
• The component itself shows any signs of damage. The component may not function properly.
• The use-by date has expired. In this case, component sterility cannot be guaranteed, and infection may occur.
• The sterile component was dropped onto a non-sterile surface. In this case, the sterility cannot be guaranteed, and infection may occur.

Usage Environment:

The following lists the appropriate temperature, humidity, and pressure usage conditions for use of the Neurostimulator:

• Temperature: 20 °C to 45 °C
• Pressure: The Neurostimulator should function at up to 10 m (33 feet) underwater (200 kPa) and at altitudes up to 3000 m (10,000 feet) associated with activities like hiking and skydiving (as low as 70 kPa)

Shipping and Storage Environment:

The following lists the appropriate temperature, humidity, and pressure conditions for shipping and storing the Neurostimulator:

• Temperature (short term: 3 days): -10 oC to 55 oC
• Humidity (short term: 3 days): 15 % to 95%
• Pressure (short term): 57 kPa to 106 kPa

If the Neurostimulator is exposed to extreme temperatures, it may be permanently damaged and should not be used, even if it has returned to a temperature that is within the specified operating range.

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.

CUSTOMER SERVICE

For questions regarding the Axonics SNM System, call our Customer Support Center toll-free at +1-877-929-6642.
Additional information and product manuals can be found at our website: www.axonics.com

December, 2021 All Rights Reserved. Copyright 2021. Axonics, Inc. 110-0230-001 Rev E
AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101
Axonics, Inc. 26 Technology Drive Irvine, CA 92618 (USA)
www.axonics.com
Tel. +1-877-929-6642
Fax + 1-949-396-6321

References

• Axonics® Therapy | Get Your Bladder Back

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