Precautions - St. Jude Medical GII Proclaim Manual De Instrucciones

Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an implanted
neurostimulation system. Contact between an active electrode and an implanted IPG, lead, or
extension can 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.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been
established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and
nursing have not been established.
Device components. The use of non-St. Jude Medical components with this system may result in
damage to the system and increased risk to the patient.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could
result from exposure to battery chemicals.
IPG disposal. Return all explanted IPGs to St. Jude Medical for safe disposal. IPGs contain batteries
as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because
explosion or fire may result.

Precautions

The following precautions apply to these components.
General Precautions
Clinician training. Implanting physicians should be experienced in the diagnosis and treatment of
chronic pain syndromes and have undergone surgical and device implantation training.
Patient selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugs
and should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures. Infections related to system implantation might
require that the device be explanted.
Electromagnetic interference (EMI). Some equipment in home, work, medical, and public
environments can generate EMI that is strong enough to interfere with the operation of a
neurostimulation system. Patients should avoid getting too close to these types of EMI sources, which
include the following examples: commercial electrical equipment (such as arc welders and induction
furnaces), communication equipment (such as microwave transmitters and high-power amateur
transmitters), high-voltage power lines, and some medical procedures (such as therapeutic radiation
and electromagnetic lithotripsy).
3
ARTMT100140147B.pdf 7 5/2/2016 3:20:10 PM