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Safety Information
Warnings
WaRNING: Medical Procedures
DO NOT have any of the following procedures
before making sure the person administering
the procedure knows that you have the RNS®
System implanted and they have consulted with
the doctor who is monitoring your use of the
RNS® System:
•
Computerized Tomography (CT or CAT)
scans.
•
Radiation therapy (such as cobalt 60 or
gamma radiation to treat cancer).
•
Lithotripsy (shock waves to break up hard
masses, such as kidney stones).
•
Electrolysis (electrical current to remove
unwanted hair).
The energy used in these procedures may
damage the RNS® System. This could result
in stimulation not being delivered, additional
surgery to remove or replace parts of the RNS®
System, serious injury, or death.
Lithotripsy and Electrolysis should not be
performed on the head or neck.
In addition, Computerized Tomography (CT or
CAT) scans should be performed only under the
following conditions:
•
The neurostimulator should be turned off
prior to the procedure if possible. This
should be done by your doctor or someone
who is authorized to adjust the settings
using the programmer.
•
The scan should be taken at the lowest
X-ray beam level possible.
•
Avoid directing the beam at or near the
implant site for more than a few seconds.
•
Emergency services need to be available
in the event you have a serious side effect.
This is especially important if the scan area
includes the implant site.
•
The neurostimulator should be turned back
on after the procedure.
4 4
WaRNING: MRI Safety Information
RNS® Neurostimulator model
RNS-320: You must consult your
doctor to determine whether an
MR
MRI scan is possible for you. The
RNS® System (with RNS
Neurostimulator model RNS-320) is MR
Conditional, which means that an MRI scan may
be safely performed under specific conditions.
It may also be possible to have an MRI scan if
your neurostimulator has been explanted. If
your doctor determines it is possible for you to
have an MRI scan, he or she must make sure
that the conditions for a safe MRI scan are
followed. Those conditions include putting your
neurostimulator in MRI Mode, which uses more
battery and may affect battery life. While in MRI
Mode, the neurostimulator is not detecting or
delivering therapy to the patient. Therefore, you
should work with your doctor to minimize the
time your neurostimulator is in MRI Mode.
RNS® Neurostimulator model
RNS-300M: DO NOT have a
MR
Magnetic Resonance Imaging (MRI)
scan if you have an RNS® System
with an RNS Neurostimulator model
RNS-300M implanted. The RNS Neurostimulator
model RNS-300M is MR Unsafe. Having an MRI
scan with an RNS Neurostimulator model
RNS-300M implanted may result in serious
injury or possible death.
RNS® System External
Components: All external
MR
components such as the magnet,
wand and remote monitor are MR
Unsafe and can pose a projectile
hazard, and therefore, must be kept out of the
MRI scanner room.
Contact your doctor as soon as possible if you
have questions or suspect your RNS® System
is not working properly after any medical
procedure.
Remote Monitor Manual Model 5106
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