Introduction; Purpose Of The Trial System; Contraindications; Warnings - Axonics 1601 Manual Del Usuario

INTRODUCTION

This manual provides information about the Axonics Sacral Neuromodulation (SNM) SystemTrial Stimulator (Model 1601), which is a
part of the Axonics SNM Trial System. The Trial Stimulator (TS) is used to provide temporary electrical stimulation to the sacral nerve.
There are two types of trials for which the TS is used. For a basic trial, the TS connects to a Peripheral Nerve Evaluation (PNE) lead to
deliver temporary electrical stimulation. For an advanced trial, theTS connects to a tined lead to deliver temporary electrical stimulation.

Purpose of the trial system

The Axonics SNM Trial System is used for a test period to evaluate if a subject should be treated with the Axonics SNM System.

CONTRAINDICATIONS

The Axonics SNM Trial System is contraindicated for patients who are unable to operate the Axonics SNM Trial System.

WARNINGS

Diathermy
Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) should
not be used on patients implanted with the Axonics SNM System. Diathermy can transmit energy through the implanted system,
potentially causing tissue damage at the location of the implanted electrodes, resulting in severe injury.
Magnetic Resonance Imaging (MRI)
An MRI should not be conducted on an individual undergoing a trial period of SNM therapy utilizing the external TS.
The following additional medical procedures that may affect the Axonics SNM System should be avoided during the trial period:
• Lithotripsy
• Monopolar electro surgery
• Microwave and Radio-frequency (RF) ablation
• Radiation therapy
• Ultrasound or scanning equipment

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. While everyday electrical devices are unlikely to affect
the TS, there are strong sources of EMI that pose a higher risk. These include theft detectors, security gates, and security wands. If
patients encounter any of these electrical devices, they should walk as far away from the sides of the device when passing through.
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