Precautions - Axonics 1901 PNE Lead Manual Del Usario

TS interaction with implanted cardiac devices - When a patient needs both an Axonics SNM System and an
implanted cardiac device, interactions between the two devices should be discussed by the patients' physicians before
surgery. Such devices may include pacemakers or defibrillators. The physicians involved may include cardiologists,
electrophysiologists, urologists, and urogynecologists. To reduce potential interference, the TS device should be worn
on the opposite side of the body. It should also be worn as far away from the cardiac device as practical.
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.
Unauthorized modifications to the Trial Stimulator
No modification of any component of the Axonics SNM System is allowed. Modification may result in more risks and
hazards.

PRECAUTIONS

Clinician programming
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 the stimulation cable or turning the simulation on or off, the stimulation amplitude should
be decreased to 0.0 mA.
Sensitivity to stimulation –Patients who are very sensitive to stimulation may be able to sense the telemetry signals
associated with reprogramming.
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. This will help
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. 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 TS and another active
implanted device the RF signal used to program any of these devices may reset or reprogram the other devices. These
devices include a pacemaker, defibrillator, or another neurostimulator.
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 TS should not be programmed near equipment that may generate EMI.
The equipment may interfere with the CP or Remote Control's ability to communicate with the TS. If EMI is suspected
to be interrupting programming, the CP or the Remote Control and the TS should be moved away from the likely source
of EMI.
Interference during medical imaging – The TS should be turned off, disconnected, and removed prior to medical
imaging (x-ray, CT). The components of the trial system may distort images or impede the ability to see certain internal
structures when performing imaging tests.
Patient activities
Activities requiring excessive twisting or stretching – Patients should avoid activities that may strain the
implanted components of the Axonics SNM System. For example, movements that include bending, twisting,
bouncing, or stretching may pull on the connection between the TS and lead(s). This may cause movement of the
lead or discomfort. It may also result in an unsuccessful trial period due to lack of adequate stimulation of the sacral
nerve. Clinicians should ask their patients about the activities in which they participate and inform them of the need
for restricted activities.
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 – Patients should not scuba dive or use a hyperbaric chamber during their
trial stimulation period.
Skydiving, skiing, or hiking in the mountains – Patients should not sky-dive, ski or go hiking during the trial
stimulation period.
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