Neuropace RNS System User Manual page 17

Responsive Neurostimulator System
Precaution: Explantation and EMI Considerations
If any system components (neurostimulator, leads, lead fragments, or cranial
prosthesis) remain implanted in the patient after a partial system explant, the patient is
still susceptible to possible adverse effects from strong sources of EMI. It is possible
for the interference sources to couple enough energy into a neurostimulator system to
damage brain tissue, resulting in serious patient injury or death. Patients who have
system components implanted should exercise caution in avoidance of devices which
generate a strong electric or magnetic field.
Refer to Electromagnetic Emissions and Immunity for more information.
Precaution: Lead Replacement and Abandoned Leads
The long-term safety associated with leads left in place without use, replacement of
leads, and lead explant is unknown.
P – P
RECAUTIONS ROGRAMMER
Precaution: Programmer Failure
As with any electronic device, the programmer may be damaged or malfunction if the
programmer AC adapter and power cord are not properly connected to a grounded
power source.
P – M
RECAUTIONS EDICAL
Precaution: Medical Procedures
Patients should always inform any healthcare personnel that they have an implanted
RNS
procedure is performed.
Advise the patient to contact their healthcare provider as soon as possible if they have
questions or suspect their device is not functioning properly after any medical
procedure.
Precaution: Electrocautery
The use of electrocautery (electrosurgery) can affect the operation of neurostimulators.
The RNS
electrocautery, however the energy levels used in electrocautery can temporarily
interfere with or cause permanent damage to device operation.
Electrocautery applied near the RNS
stop sensing, delivering therapy, or may reset the neurostimulator. Under these
conditions the neurostimulator may require interrogation and possible reprogramming.
Electrocautery applied directly to the neurostimulator or leads may couple enough
energy into a neurostimulator system to damage brain tissue.
If electrocautery is necessary, the following recommendations may be effective in
minimizing potential complications.
Before the procedure:
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RNS System User Manual
E
NVIRONMENT
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System (and show their medical implant identification card) before any
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System has been designed to prevent or minimize the effects of
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Neurostimulator may cause it to temporarily
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