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Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
specific configurations of the item, may be
required.
MRI – Magnetic Resonance Imaging.
Radio Frequency (RF) – electrical fields
whose frequencies are in the range of
10,000 Hz and above.
Specific Absorption Rate (SAR)
normalized rate at which RF energy is
deposited in biological tissue. SAR is typically
indicated in W/kg.
Tesla (T) – the unit of measure of
magnetic field strength. One T is equal to
10,000 Gauss.
MRI Transmit/Receive RF Body coil – a coil
used to transmit and to receive RF energy
that encompasses the entire body region
within the MR system bore.
MRI Transmit/Receive RF Head coil – a coil
used to transmit and to receive RF energy
that is constrained to the head region, only.
W/kg – Watts per kilogram, a measure of the
power that is absorbed per kilogram of tissue.
INTRODUCTION
Magnetic Resonance Imaging (MRI)
uses a powerful static magnetic field,
gradient magnetic fields, and RF energy
to create images useful for the diagnosis
of various diseases and conditions. These
electromagnetic fields may interact with
implants and cause movement and/
or excessive heating of or around the
implanted components, damage to the
device electronics and/or voltage induction
through the leads and Stimulator causing
an uncomfortable "jolting" sensation. In
addition, the metallic components of the
Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
90719336-04 Rev B 2 of 155
neurostimulation systems can affect the MRI
image, potentially impacting the diagnostic
use of this modality. Therefore, because
of these potential deleterious effects, it is
imperative to thoroughly read, understand,
and comply with the instructions, cautions,
and warnings in this document to prevent
– the mass
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harm to the patient undergoing MRI
examination.
MRI procedures involving the use of
transmit or transmit/receive RF body
coils are strictly prohibited due to the
high likelihood of causing excessive
MRI-related heating of the implanted
components.
If all of the instructions stated in this
document are followed, MRI examinations of
the head using a transmit/receive RF head
coil of a 1.5-Tesla horizontal bore MRI system
may be safely performed.
Boston Scientific has conducted testing
consistent with ASTM standards F2052
magnetically induced displacement force,
F2213
F2182
testing of the Precision™ SCS System to
ASTM F2052-02, "Standard Test Method for
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Measurement of Magnetically Induced Displacement
Force on Medical Devices in the Magnetic Resonance
Environment"
ASTM F2213-04, "Standard Test Method for
3
Measurement of Magnetically Induced Torque
on Medical Devices in the Magnetic Resonance
Environment"
ASTM F2182-02a, "Standard Test Method for
4
Measurement of Radio Frequency Induced Heating
Near Passive Implants during Magnetic Resonance
Imaging"
for magnetically induced torque, and
3
for RF heating as well as functional
4
for
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