Tabla de contenido
Publicidad
define the recommendations and guidelines
contained within this document.
The instructions in this document describe
how to conduct a head-only MRI examination
of a patient with the Precision SCS System,
using a transmit/receive RF head coil of a
1.5-Tesla, horizontal bore MRI system.
WARNINGS
MRI Transmit or Transmit/Receive RF
Body Coil. Patients implanted with the
Precision System should not be subjected
to a MRI transmit or transmit/receive RF
body coil. MRI exposure may result in
dislodgement of implanted components,
heating of the neurostimulator, damage to the
device electronics and/or voltage induction
through the leads and Stimulator causing an
uncomfortable or "jolting" sensation.
MRI Transmit/Receive RF Head Coil. An
MRI examination of the head only (no other
part of the body) can be conducted safely
using only a transmit/receive RF head coil of
a 1.5-Tesla horizontal bore MRI system when
all instructions in this document are followed.
The use of a transmit/receive RF head coil
constrains the majority of the RF fields to the
head region and away from the implanted
components of the Precision System. MRI
examinations performed on patients with
the Precision System using open-sided MRI
systems, or other types of MRI systems
operating at other static magnetic field
strengths (higher or lower) have not been
assessed and, as such, should not be
performed.
Limitations
• MRI should not be considered for patients
with the Precision SCS System if other
potentially safer diagnostic methods such
as computed tomography, X-ray, or other
methods will provide adequate diagnostic
information for patient management.
• The instructions in this document apply
to all implanted components of the
Precision SCS System, consisting of
Boston Scientific IPG, leads, surgical
accessories, and extensions. Contact
Boston Scientific at the telephone number
or address listed at the end of this
document for information about newer
models or any updates.
• If the patient has any other active
or passive medical implant from
a manufacturer that prohibits or
contraindicates an MRI examination,
follow the instructions from the
manufacturer. The instructions in this
document apply only to Boston Scientific
products described herein.
• Physicians should not prescribe MRI for
patients undergoing trial neurostimulation
and/or having systems that are not fully
implanted.
• Do not remove the IPG and leave the
lead system implanted as this can result
in higher than expected lead heating.
Excessive heating can cause tissue
damage.
• Allow at least six weeks time from
the date of Precision SCS System
implantation to the time of the MRI
examination.
Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
WARNINGS
90719336-04 Rev B 3 of 155
Publicidad
Tabla de contenido
