Warnings - Boston Scientific Precision SC-1110 Serie Manual De Uso

Boston Scientific has conducted testing
consistent with ASTM standards F2052
magnetically induced displacement force,
F2213 for magnetically induced torque, and
3
F2182 for RF heating as well as functional
4
testing of the Precision System to 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 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
2 ASTM F2052-02, "Standard Test Method for
Measurement of Magnetically Induced Displacement
Force on Medical Devices in the Magnetic Resonance
Environment"
3 ASTM F2213-04, "Standard Test Method for
Measurement of Magnetically Induced Torque
on Medical Devices in the Magnetic Resonance
Environment"
4 ASTM F2182-02a, "Standard Test Method for
Measurement of Radio Frequency Induced Heating
Near Passive Implants during Magnetic Resonance
Imaging"
using only a transmit/receive RF head coil of
for a 1.5-Tesla horizontal bore MRI system when
2
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 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 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.
9055959-008 Rev A 65 of 327
Appendix A
Clinician Manual