Appendix A; Tesla Mri Guidelines To Physicians For Patients With Precision System; Definition Of Terms - Boston Scientific Precision SC-1110 Serie Manual De Uso

Appendix A

1.5 Tesla MRI Guidelines to
Physicians for Patients with
Precision System
Note: MRI Transmit Receive RF Head Coil
is not approved for use with Peripheral
Nerve Stimulation.
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 System. The implanted
portions of the Precision System consists of
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 of 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 risk of
using MRI systems operating at other
static magnetic field strengths or using
a transmit or transmit/receive RF body
coil has not been determined.
The Precision System is "MR Conditional"
when exposed to 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), radio frequency (RF) transmit/receive
head coil, and whole body averaged specific
absorption rate (SAR). Additional conditions,
including specific configurations of the
Precision 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 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.

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.
1 ASTM F 2503-08, "Standard Practice for Marking
Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment"
9055959-008 Rev A 63 of 327
Appendix A
1
Clinician Manual