Axonics 2501 Handbuch Seite 11

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.
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The stimulation amplitude should be allowed to ramp to full amplitude slowly.
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Before disconnecting a stimulation cable or turning stimulation on or off, the stimulation amplitude should be
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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
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.
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