Precautions; Parameter Adjustment; Sensitivity To Stimulation; Programmer Interaction With Flammable Atmospheres - Axonics 2501 Manuel

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 a
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 immediately if they experience symptoms
8 8
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.