Axonics 1601 Manual Del Usuario página 8

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 gas. 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 Radio Frequency (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 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 twisting or stretching –
Patients should avoid activities that may strain the connections between the implanted components of the Axonics SNM System and
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