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This document is a supplement to the
Precision System product manuals and
relates specifically to the use of a transmit/
receive radio frequency (RF) head coil of
a 1.5 Tesla horizontal bore MRI system
for patients implanted with the Boston
Scientific Precision Spinal Cord Stimulator
(SCS) System. The implanted portions of
the Precision SCS System can include
Boston Scientific percutaneous leads, lead
extensions, surgical paddle leads, surgical
accessories, and implantable pulse generator
(IPG).
Important Note: MRI procedures should
be performed using only a transmit/receive
RF head coil in a 1.5-Tesla horizontal bore
MRI system, ONLY. Do not use open-sided
or MRI systems operating at other static
magnetic field strengths. The risks of using
MRI systems operating at other static
magnetic field strengths or using a transmit or
transmit/receive RF body coil have not been
determined.
The Precision SCS System is
"MR Conditional"
when exposed to
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the magnetic resonance imaging (MRI)
environment under the specific conditions
defined in this document. These include the
strength of the static magnetic field, spatial
gradient of the static magnetic field, time rate
of change of the magnetic field (dB/dt), use
of a radio frequency (RF) transmit/receive
head coil, head averaged specific absorption
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ASTM F 2503-08, "Standard Practice for Marking
Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment"
rate (SAR), and Normal Mode MRI scanner
operation. Additional conditions, including
specific configurations of the Precision SCS
System, are required as specified throughout
this document.
It is important to read this information
in its entirety before conducting or
recommending an MRI examination on
a patient with a Precision SCS System.
These instructions do not apply to other
implantable products or other devices,
products, or items. Contact Boston
Scientific at the address or phone number
listed at the end of this document if you
have any questions. These instructions
also appear on the Boston Scientific
website (www.bostonscientific.com).
Definition of terms
ASTM International – the American Society
for Testing and Materials, an international
standards forming body.
dB/dt – the change of magnetic field strength
per unit of time, measured in units of Tesla
per second.
Hertz (Hz) – a unit of frequency in Hertz or
cycles per second.
MR Conditional
demonstrated to pose no known hazards in
a specified MR environment with specified
conditions of use. Field conditions that
define the specified MR environment include
field strength, spatial gradient, dB/dt (time
rate of change of the magnetic field), radio
frequency (RF) fields, and specific absorption
rate (SAR). Additional conditions, including
Precision™ Spinal Cord Stimulator System 1.5 Tesla MRI Guidelines
Definition of terms
– an item that has been
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90719336-04 Rev B 1 of 155
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