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Introduction
6
RNS
®
System Programming Manual
W
ARNINGS AND
C
AUTIONS
–
P
ROGRAMMER
Note: See the RNS
®
System manual for warnings and cautions regarding other components of
the RNS
®
System.
WARNING:
P
HYSICIAN AND CENTER ACCESS TO THE
RNS
®
S
YSTEM
The RNS
®
System should only be implanted by neurosurgeons with adequate
experience in the implantation of subdural and stereotactic implantation of
intraparenchymal electrodes and in the surgical treatment of intractable epilepsy. The
RNS
®
System should only be used by neurologists or neurosurgeons with adequate
experience in the management of intractable epilepsy and in the localization of
epileptic foci, including the use of scalp and intracranial electrodes.
Neurologists and neurosurgeons using the RNS
®
System must have completed the
NeuroPace
®
RNS
®
System training program. To qualify to manage patients with the
RNS
®
System, physicians must demonstrate specific expertise related to epilepsy,
video-EEG monitoring, interpretation of electrocorticograms (ECoGs), the
pharmacology of antiepileptic medications and selection of patients for epilepsy
surgery. Implantation of the RNS
®
System should be performed only by qualified
neurosurgeons at centers capable of providing comprehensive epilepsy care, i.e.
“Comprehensive Epilepsy Centers.” These centers should have the expertise to
provide diagnostic services that include video-EEG monitoring with scalp and
intracranial electrodes and neuroimaging, and are experts in the treatment of epilepsy
with antiepileptic medications, epilepsy surgery, and devices.
WARNING:
M
ANAGEMENT OF PATIENTS WITH THE
RNS
®
S
YSTEM BY PHYSICIANS AT CENTERS THAT DO
NOT PROVIDE THE SERVICES PROVIDED AT COMPREHENSIVE EPILEPSY CENTERS
In some instances, post-implant programming may be conducted by neurologists
meeting the experience and certification requirements for neurologists at
Comprehensive Epilepsy Centers, but who are not practicing in such centers. This
situation might occur if the patient is not able to travel to a Comprehensive Epilepsy
Center for regular follow-up (e.g. because of distance from the Center or limited
access to transportation). These neurologists will be qualified by NeuroPace to provide
post-implant programming. After NeuroPace
®
RNS
®
System training is complete, the
qualified programming neurologist may receive external NeuroPace products
(programmer, remote monitor).
WARNING:
P
OTENTIAL
S
HOCK
Submerging any part of the programmer, or operating the programmer in or near a wet
environment, may result in an electrical shock.
The programmer must be disconnected from the electrical outlet prior to cleaning to
avoid the potential of electrical shock.
Electrical shock may occur if the programmer AC adapter and power cord are not
properly connected to a grounded power source.
WARNING:
R
ADIO
F
REQUENCY
I
DENTIFICATION
(RFID)
I
NTERFERENCE
Sources of RFID can result in signals that appear as ECoG activity to the
neurostimulator. Signals that appear as ECoG activity could also result in delivering
Summary of Contents for PDMS 4340
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