Patient Activities - Axonics 1201 Mode D'emploi

Programmer interaction with a cochlear implant – Patients with cochlear implants should keep the external
portion of their cochlear implant as far from the Clinician Programmer (CP) or Remote Control as possible to
minimize unintended audible clicks or other sounds.
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 Neurostimulator and
another active implanted device (for example, a pacemaker, defibrillator, or another neurostimulator), 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 that are likely to be related to the devices or their medical condition.
Telemetry signal disruption from EMI – The Neurostimulator should not be programmed near equipment that
may generate electromagnetic interference (EMI) as the equipment may interfere with the CP or Remote Control's
ability to communicate with the Neurostimulator. If EMI is suspected to be interrupting programming, the CP or the
Remote Control and the Neurostimulator should be moved away from the likely source of EMI.

Patient activities

Activities requiring excessive twisting or stretching – Patient activities that may strain the implanted
components of the Axonics SNM System should be avoided. For example, movements that include sudden,
excessive, or repetitive bending, twisting, bouncing, or stretching may cause migration or breakage of the SNM
leads. Lead breakage or migration may cause loss of stimulation, intermittent stimulation, or stimulation at the
fracture site. Additional surgery may be required to replace or reposition the component. Activities that typically
involve these movements include gymnastics, mountain biking, and other vigorous sports. Clinicians should ask
their patients about the activities in which they participate and inform them of the need for restricted activities.
Charging use – If swelling or redness occurs near the Charger attachment site, the patient should contact their
clinician before using the Charger again. Swelling or redness may indicate an infection or an allergic reaction to the
Charger adhesive.
Component manipulation by patient (Twiddler's syndrome) – Clinicians should advise patients to refrain
from manipulating the Axonics SNM System through the skin. Manipulation may cause device damage, lead
migration, skin erosion, or uncomfortable stimulation.
Scuba diving or hyperbaric chambers – Pressures below 10 meters (33 feet) of water (or above 200 kPa could
damage the Axonics SNM System. Diving below 10 meters (33 feet) of water or entering hyperbaric chambers above
200 kPa should be avoided. Patients should discuss the effects of high pressure with their physician before diving
or using a hyperbaric chamber.
Skydiving, skiing, or hiking in the mountains – High altitudes should not affect the Neurostimulator.
Nevertheless, patients should be cautious with high altitude activities due to the potential for movements that
may put stress on the implanted components. For example, the sudden jerk that occurs when a parachute opens
while skydiving may cause lead breakage or migration, which may require surgery to remove or replace the lead.
Unexpected changes in stimulation – A perceived increase in stimulation may be caused by electromagnetic
interference, postural changes, and other activities. Some patients may find this uncomfortable (a jolting or
shocking feeling). Before engaging in activities that receiving a jolt would be unsafe for the patient or those around
them, patients should lower the stimulation amplitude to the lowest setting and turn off the Neurostimulator.
Patients should also discuss these activities with their clinician.
Patient programming and Remote Control
Patient access to Remote Control – Patients should carry their Remote Control with them at all times to allow
them to adjust the stimulation amplitude and/or turn on/off the Neurostimulator.
Remote Control may affect other implanted devices – Patients should avoid placing the Remote Control over
or near other active implanted medical devices (for example pacemaker, defibrillator and other neurostimulators).
Remote Control handling – To avoid damaging the Remote Control, patients should avoid immersing it in liquid
and should clean it with water and a soft cloth. Patients should avoid dropping the device or mishandling it in any
way that may damage it.
Remote Control use – Patients should avoid operating the Remote Control when near flammable or explosive
gases.
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