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Axonics 1601 Manual

Sacral neuromodulation system trial stimulator, rx only
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Sacral Neuromodulation System
Trial Stimulator Manual
Model 1601
Rx only
Axonics®, Axonics Modulation®, Axonics Modulation Technologies® and
Axonics Sacral Neuromodulation System® are trademarks of Axonics Modulation Technologies, Inc.,
registered or pending registration in the U.S. and other countries.

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Summary of Contents for Axonics 1601

  • Page 1 Sacral Neuromodulation System Trial Stimulator Manual Model 1601 Rx only Axonics®, Axonics Modulation®, Axonics Modulation Technologies® and Axonics Sacral Neuromodulation System® are trademarks of Axonics Modulation Technologies, Inc., registered or pending registration in the U.S. and other countries.
  • Page 2 Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonicsmodulation.com Tel. +1-877-929-6642 Fax +1-949 396-6321...

  • Page 3: Label Symbols

    LABEL SYMBOLS This section explains the symbols found on the product and packaging. Symbol Description Symbol Description Axonics Trial Stimulator Do not reuse Protection from the amount of dust Trial Stimulator default waveform with 14 and splashing water that would IP24 0 mA Hz frequency, 0 mA amplitude and 210 µs...
  • Page 4 Symbol Description Symbol Description Conformité Européenne (European Conformity). This symbol means that the device fully Product cannot be discarded in trash. complies with AIMD Directive 90/385/EEC See instructions on disposal of the (Notified Body reviewed) and RED 2014/53/EU product. (self-certified) Refer to instructions for use (Consult IEC 60601-1/EN60601-1, Type BF accompanying documents)

  • Page 5: Table Of Contents

    TABLE OF CONTENTS LABEL SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Patient activities .

  • Page 6: Introduction

    DEVICE DESCRIPTION The Axonics TS (Figure 1) is part of the Axonics SNM System. The TS is a programmable device that is worn on the outside of the body. The TS delivers electrical stimulation to the sacral nerve via connections to either a permanent or temporary lead.

  • Page 7: Package Contents

    The contents of the package are NOT STERILE. The contents of the package are intended for single use only. CONTRAINDICATIONS The Axonics SNM Trial System is contraindicated for patients who are unable to operate the Axonics SNM Trial System. WARNINGS...

  • Page 8: Electromagnetic Interference (Emi)

    Electromagnetic interference (EMI) EMI is energy that can interfere with the function of the Axonics SNM System. This energy can be generated by equipment found at home, work, or in public. The Axonics SNM System includes features that provide protection from EMI. Most electrical devices encountered in a normal day are unlikely to affect the operation of the TS.

  • Page 9: Stimulator

    It should also be worn as far away as practical from an implanted cardiac device. The stimulation pulses produced by the Axonics SNM System may interact with cardiac devices that sense cardiac activity. This may lead to inappropriate behavior of the cardiac device.

  • Page 10: Electromagnetic Interference (Emi)

    Electromagnetic interference (EMI) Patients may encounter additional equipment that generates EMI. This equipment is unlikely to affect the Axonics SNM System if the patients follows these guidelines: Bone growth stimulators – The external coils of bone growth stimulators should be kept at least 45 cm (18 in) away from the Axonics SNM System.
  • Page 11 Axonics SNM System. Discontinue using TENS if it starts affecting the performance of the Axonics SNM System. If a patient thinks that an EMI generating equipment or environment is affecting the function of their Axonics SNM System, the patient should: 1.

  • Page 12: Patient Activities

    Activities requiring twisting or stretching – Patients should avoid activities that may strain the connections between the implanted components of the Axonics SNM System and the TS. For example, movements that include bending, twisting, bouncing, or stretching may pull on the connection between the TS and the lead(s). This may potentially cause movement of the lead or discomfort and may result in an unsuccessful trial period due to lack of adequate stimulation of the sacral nerve.

  • Page 13: Patient Programming And Remote Control

    TS and keep their lead implant site and their surgical dressings dry. Patients should be advised on avoiding showers and baths by their physician. Patient programming and Remote Control Patient access to Remote Control – Patients should carry their Remote Control with them at all times. This will allow them to adjust the stimulation amplitude and/or turn on/off the TS.

  • Page 14: Sterilization

    Use of non-Axonics components will void Axonics warranty coverage . Component failures – The components of the Axonics SNM System may fail at any time. Failures such as electrical shorts, open circuits, and insulation breaches are unpredictable. Also, the TS battery will eventually run out and can provide no more than 60 days of stimulation.

  • Page 15: Individualization Of Treatment

    Neurostimulator • The patient can properly operate the Axonics SNM System. This includes the ability to use the Remote Control, to detect alignment of the Charger, and to understand when charging is complete...

  • Page 16: Patient Counseling Information

    • Information about the components of the Axonics SNM System • Instructions for using the Remote Control Also, the clinician should provide each patient with a copy of the Axonics SNM System Patient Therapy Guide. The clinician should review the following sections with him/her: •...

  • Page 17: Specifications

    SPECIFICATIONS Table 1 shows the TS physical specifications. For detailed descriptions and specifications for other components and accessories, refer to the product literature packaged with those devices. Table 1 . TS specifications Physical Attributes Height 45 mm Length 45 mm Thickness 12.5 mm Weight...

  • Page 18: Activating The Trial Stimulator

    The following section describes the process for activating the TS for delivering stimulation. This should be performed when an Axonics lead has already been implanted and a Clinician Programmer is available. 1. Press the button on the back of the TS (Figure 2). The green light next to the button will start to flash. The green light will flash for 90 seconds.

  • Page 19: Lead Or Pne Lead

    The following section describes the process for connecting the TS to the cables used to connect to the tined lead or the PNE lead. This should be performed when an Axonics lead has already been implanted and the appropriate cables are available. For a trial using the PNE lead, the Basic Trial Cable should be connected to the TS.

  • Page 20: Replacement And Disposal

    Figure 4: Fasten the belt on the patient’s body and adjust the width as necessary. Figure 5: Insert the TS into the pouch on the belt. REPLACEMENT AND DISPOSAL Replacement: If the TS is lost, visibly damaged, or not working, the patient should contact their physician to get a new TS. Disposal: At the end of a trial stim period, the patient should return the TS to their physician.

  • Page 21: Wireless Communication

    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 TS are not authorized by Axonics could void FCC and IC certification and negate the user’s authority to use the product.

  • Page 22: Customer Service

    Wireless Security: The TS 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 TS. Additional mechanisms exist to ensure the integrity of radio data.
  • Page 24 HealthLink Europe Services BV De Tweeling 20-22 5215 MC ’s – Hertogenbosch The Netherlands All Rights Reserved. Copyright 2019. Axonics Modulation Technologies (11-14-2019) 110-0078-001 rD...

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