Boston Scientific Precision Novi Manual Del Usuario página 6

Information for Patients
Warnings
UNAUTHORIZED MODIFICATION: Unauthorized modification to the medical devices is prohibited.
System integrity could be compromised and harm or injury to the patient could occur if the medical
devices are subjected to unauthorized modification.
Magnetic Resonance Imaging (MRI). You should not be exposed to Magnetic Resonance Imaging
(MRI). Exposure to this diagnostic technology may result in tissue damage, dislodgement of your
Stimulator or leads, heating of the Stimulator, severe damage to the Stimulator electronics and/
or increased voltage through the leads or Stimulator which can cause an uncomfortable or "jolting"
sensation. The Precision Novi System has not been evaluated for safety and compatibility in the MR
environment. The Precision Novi System components have not been tested for heating or migration
in the MR environment. Introducing a patient with this device into an MRI scanner may result in
severe patient injury, death, or device malfunction.
Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for
pediatric use.
Diathermy. As an SCS patient, you should not have any form of diathermy either as treatment
for a medical condition or as part of a surgical procedure. The high energy and heat generated by
diathermy can be transferred through your stimulator system, causing tissue damage at the lead site
and, possibly, severe injury or death. The Stimulator, whether it is turned on or off, may be damaged.
Precision Novi™ System Information for Patients
90971728-03 REV A 4 of 491