Responsive Neurostimulator System
13
RNS
®
System User Manual
System. This could result in loss of therapy, and additional surgery to remove or
replace components of the RNS
®
System. Prior to any administration of lithotripsy, the
administering physician should consult with the physician prescribing the RNS
®
System.
WARNING: R
ADIATION
The effects of high radiation sources (such as cobalt 60 or gamma radiation used in
cancer therapy) on the RNS
®
System have not been studied. Exposure to high levels
of radiation may damage the RNS
®
System. This could result in loss of therapy, and
additional surgery to remove or replace components of the RNS
®
System. Prior to any
course of radiation therapy, the radiation oncologist should consult with the physician
prescribing the RNS
®
System.
WARNING: E
LECTROLYSIS
The effects of electrolysis on the RNS
®
System have not been studied. Electrolysis on
the head or neck should be avoided.
WARNING: C
OMPUTERIZED
T
OMOGRAPHY
(CT)
S
CANS
For CT procedures on a patient with an implanted RNS
®
Neurostimulator, the operator
should:
•
Ask the patient to have the neurostimulator temporarily shut off with a programmer
while the scan is performed, if possible.
•
Minimize x-ray exposure to the implanted electronic medical device by:
•
Using the lowest possible x-ray tube current consistent with obtaining the required
image quality.
•
Making sure that the x-ray beam does not dwell over the device for more than a
few seconds.
Important note: For CT procedures that require scanning over the medical device
continuously for more than a few seconds, as with CT perfusion or interventional
exams, attending staff should be ready to take emergency measures to treat adverse
reactions if they occur.
After CT scanning, the operator should:
•
Ask the patient to have the neurostimulator turned back on with a programmer if it
had been turned off prior to scanning.
•
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.
