Warnings - Synapse NeuRx Handbuch

3.0

WARNINGS

· This device should be used only under the direction of a physician.
· The patient must always have a back-up means of breathing help (ventilation)
available. If the patient thinks there is any problem with the NeuRx DPS, then they
should use their back-up means right away. They should turn off the NeuRx DPS
when they switch to their back-up means of breathing help.
· NeuRx DPS could interfere with some medical equipment.
equipment could interfere with the NeuRx DPS:
o All active implantable medical devices. This will include devices such as
implanted cardiac pacemakers, implanted cardioverter defibrillators (ICDs),
implanted neurostimulators, and body worn medical devices (e.g., insulin
pump). Use of the NeuRx EPG stimulator may interfere with these devices.
o Surgery. Use of high-frequency surgical equipment may cause burns
where the electrode wires pass through the skin. It might also damage the
NeuRx EPG if connected.
o Diathermy treatment. Diathermy treatment should not be performed within
30cm of the implanted electrode leads. Unwanted tissue heating through
the electrode leads could occur.
o External electrical stimulation such as transcutaneous electrical nerve
stimulation (TENS). Such stimulation should not be done in the chest area
near the electrode wires. Unwanted diaphragm contraction could occur.
o Shortwave or microwave therapy. Operating the NeuRx DPS close to
(about 3 feet from) such equipment may interfere with your NeuRx DPS.
Magnetic Resonance Imaging (MRI) test. The PermaLoc
o
is MR Unsafe. Do not perform a MRI test while implanted with the PermaLoc
electrodes.
Magnetic Resonance Imaging (MRI) test. The NeuRx EPG stimulator
o
and surface electrodes are MR Unsafe. The NeuRx DPS has not been
tested with MRI. MRI could cause the electrode wires to move. MRI could
also cause unwanted tissue heating through the electrode wires.
· Avoid trans-thoracic stimulation.
· Avoid accidental contact between connected but unused applied parts (cable or
leads) and other conductive parts including those connected to protective earth.
· The long-term effects of chronic electrical stimulation are unknown.
WARNINGS (con't)
· Safety has not been established for the use of the device during
pregnancy.
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Some medical
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electrode