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AXONICS F-15®
Neurostimulator
Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., registered or pending registration in the U.S.
AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101
Implant Manual
Recharge-Free | Model 4101
Rx only
and other countries.
Axonics, Inc.
26 Technology Drive
Irvine, CA 92618 (USA)
www.axonics.com
Tel. +1-(877) 929-6642
Fax +1-(949) 396-6321
Page 1
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Summary of Contents for Axonics F-15
- Page 1 AXONICS F-15® Neurostimulator Implant Manual Recharge-Free | Model 4101 Rx only Axonics® and Axonics Sacral Neuromodulation System® are trademarks of Axonics, Inc., registered or pending registration in the U.S. and other countries. Axonics, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonics.com...
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Page 2: Label Symbols
Manufacturer Product Model Number Manufacturing Date Non-ionizing electromagnetic radiation Refer to instructions for use available electronically. Temperature limitation Humidity limitation Pressure limitation Do not reuse Sterilized using Ethylene oxide AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 2... - Page 3 FCC ID US Federal Communications Commission device identification This device is packaged in two sterile barriers The Neurostimulator is connected to the Axonics Tined Lead Model 1201 (also included in Model 2201) AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101...
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Page 4: Table Of Contents
Connecting the Lead to the Neurostimulator ..... 10 Implanting the Neurostimulator ........11 Completing the Implant Procedure ........12 Post-Surgery Management ..........12 Replacing the Neurostimulator .......... 12 WIRELESS COMMUNICATION ......13 CUSTOMER SERVICE .......... 14 AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 4... -
Page 5: Introduction
DEVICE DESCRIPTION The Axonics Recharge-Free Neurostimulator ( Figure 1) is part of the Axonics SNM System. The Neurostimulator is a programmable device that is connected to the Axonics Tined Lead, which conducts stimulation pulses to the sacral nerve. Figure 1: Axonics Recharge-Free Neurostimulator. -
Page 6: Storage And Usage Environment
Sterilization The contents of this package have been sterilized using ethylene oxide. This device is for single use only and should not be re-sterilized. AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 6... -
Page 7: Specifications
Setscrew Titanium Adhesive Silicone Torque wrench Torque wrench handle Polyetherimide Torque wrench shaft Stainless steel Note: The Neurostimulator case, which contains the electronics and power source, is hermetically sealed. AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 7... -
Page 8: X-Ray Identification
The radiopaque marker allows physicians to identify the manufacturer and model number under standard x-ray procedures. For the Axonics Neurostimulator, the designated code is RDP, which appears as light characters on a black background (Figure 2). Figure 2: The Axonics Neurostimulator radiopaque marker, “RDP”. -
Page 9: Neurostimulator Implant Procedure
NEUROSTIMULATOR IMPLANT PROCEDURE The following section describes the procedure for implanting the Axonics Neurostimulator. This procedure should be performed when an Axonics tined lead has already been implanted. Procedure Supplies In addition to the general surgical tools required by the physician, the following supplies are needed for the preparation, implantation, programming, and Remote Control pairing of the Neurostimulator: •... -
Page 10: Connecting The Lead To The Neurostimulator
Marker D on the lead should be inside the Neurostimulator strain relief (Figure 5). The retention sleeve on the tined lead should be positioned under the Neurostimulator setscrew. Figure 5: Insert Lead Fully into the Neurostimulator Connector Block. AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 10... -
Page 11: Implanting The Neurostimulator
Neurostimulator (Figure 7) or place under the Neurostimulator to minimize interference with Cautions telemetry during programming. Figure 7: Wrap Excess Lead Around or Under, but not on Top of, the Neurostimulator. AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 11... -
Page 12: Completing The Implant Procedure
The patient should carry the Remote Control at all times to be able to adjust or turn off the Neurostimulator. Caution 5. Complete the system registration paperwork and return to Axonics. 6. Schedule the patient’s follow-up visits at regular intervals to ensure that the stimulation is programmed optimally. Post-Surgery Management Patients should be monitored post implant. -
Page 13: Wireless Communication
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. -
Page 14: Customer Service
CUSTOMER SERVICE For questions regarding the Axonics SNM System, call our Customer Support Center toll-free at +1-877-929-6642 or email at customersupport@axonics.com Additional information and product manuals can be found at our website: www.axonics.com 2023-09 All Rights Reserved. Copyright 2023. Axonics, Inc.
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