from diathermy can be transferred through the implanted system and cause tissue damage at the location
of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This
damage could result in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system
is turned on or off.
Explosive or flammable gases.
Do not use the stimulator in an environment where explosive or flammable
gas fumes or vapors are present, including hyperbaric chambers. The operation of the stimulator could
cause them to ignite, causing severe burns, injury or death.
Electrosurgery devices.
Electrosurgery devices should not be used in close proximity to an implanted
neurostimulation device. Contact between an active electrode and an implanted lead or extension can
cause direct stimulation of the tissue at the electrode site and cause severe injury to the patient. If use of
electrocautery is necessary, first turn off the neurostimulation system.
Implanted cardiac systems.
Physicians need to be aware of the risk and possible interaction between a
neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical
pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac
system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac
system from sensing the output of the neurostimulation system, (1) maximize the distance between the
implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the
implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s
can as an anode) or using neurostimulation system settings that interfere with the function of the
implantable cardiac system.
Magnetic resonance imaging (MRI).
Patients with an EPG should not be subjected to MRI. Even if the leads
are removed the patient should not have an MRI if any part of a lead is still implanted.
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