Precautions; Parameter Adjustment; Sensitivity To Stimulation; Programmer Interaction With Flammable - Axonics 2501 Manual Del Instrucciones

PRECAUTIONS

Parameter adjustment

The steps below should be taken to prevent sudden
stimulation changes that lead to an uncomfortable jolting or
shocking feeling:
Stimulation parameters should be changed in small
■
increments .
The stimulation amplitude should be allowed to ramp to full
■
amplitude slowly .
Before disconnecting a stimulation cable or turning
■
stimulation on or off, the stimulation amplitude should be
decreased to 0 .0 mA .

Sensitivity to Stimulation

Some patients, especially those that are very sensitive to
stimulation, may be able to sense the telemetry signals
associated with the CP communicating with the Stimulator .
Programmer Interaction with Flammable Atmospheres
The CP is not intended to be used in the presence of
flammable gases, and the consequences of using the CP in
such an environment is not known .

Programmer Interaction with Other Active Implanted Devices

When a patient has a Stimulator and an active implanted
device (for example, a pacemaker, defibrillator, or another
Stimulator), the RF signal used to program any of these
devices may reset or reprogram the other devices .
Whenever the settings for these devices are changed, a
clinician familiar with each device should check the program
settings of each device before the patient is released (or as
soon as possible) . Patients should contact their physician
8 8
immediately if they experience symptoms that are likely to be
related to the devices or their medical condition .

Telemetry Signal Disruption from EMI

The Stimulator should not be programmed near equipment
that may generate electromagnetic interference (EMI) as the
equipment may interfere with the CP's ability to communicate
with the Stimulator . If EMI is suspected to be interrupting
programming, the CP and the Stimulator should be moved
away from the likely source of EMI .

Unintended Use

The CP is intended for use during implantation and
programming of the Axonics SNM System . It should only be
used with manufacturer provided accessories . Do not use
the CP for stimulation or other purposes not described in this
manual . Unintended use can result in user or patient injury .

Accidental Electrode Contact

Avoid accidental contact between connected but unapplied
electrodes and other conductive parts, including those
connected to protective earth .
Warning: Shortwave diathermy, microwave diathermy,
or therapeutic ultrasound diathermy (collectively described
as diathermy) should not be used during implantation of
the Axonics SNM System or on patients implanted with the
Axonics SNM System . Diathermy can transmit energy through
the CP and accessories or the implanted system, potentially
causing tissue damage at the location of the surface or
implanted electrodes, resulting in severe injury .