Boston Scientific Precision SC-1110 Serie Manual De Uso página 70

Precision™ System Clinician Manual
Note: The requirements provided in this
document are based on in-vitro
testing and should result in a safe
MRI examination of a patient with
the Precision System when all
instructions in this document are
followed. However, due to the many
variables that affect safety, the safety
of patients or continued functionality of
the Precision System exposed to MRI
cannot be absolutely ensured. The
physician assumes full responsibility
for the consequences of conducting
an MRI examination on a patient with
the Precision System.
Preparation for the MRI Examination
The following procedures must be followed
prior to performing an MRI examination on a
patient with the Precision System:
1. Determine if the patient has an implant
or condition that would prohibit or
contraindicate the MRI examination. Do
NOT conduct an MRI examination if any
implant or condition is present that would
prohibit or contraindicate the procedure.
2. Allow at least four weeks from the date of
Precision System implantation to the time
of the MRI examination to allow fibrous
encapsulation of the SCS IPG.
3. If the IPG is implanted in the subclavicular
area it is recommended that restrictive
bandaging be applied over the IPG to
prevent significant movement or torque
of the IPG by forces that may be created
by the static magnetic field of the MRI
system.
Clinician Manual
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4. Inform the patient of the risks of
undergoing an MRI examination as stated
in this document including implanted
component movement and/or excessive
heating, and that the metallic components
of the neurostimulation systems can affect
the MRI image, potentially impacting the
diagnostic use of this modality.
5. Limit the amount of sedation so that
the patient can inform the MRI system
operator of discomfort, unusual sensation,
or other problem.
6. Instruct the patient to immediately
inform the MRI system operator if any
discomfort, stimulation, shocking, or
heating occurs during the examination.
7. Carefully monitor the patient throughout
the MRI examination using audio and
visual techniques.
8. The radiologist or an MRI physicist must
verify that all proposed MRI examination
parameters comply with the "MRI
exposure requirements" listed above. If
not, the parameters must be modified to
meet these requirements. If parameters
cannot be modified, do NOT perform the
MRI examination.
9. If the patient has implanted leads but
does not have an IPG, do NOT perform
an MRI examination.
10. If the patient has an implanted
neurostimulator, perform the following
steps:
a) Review the neurostimulator
stimulation parameters with a
clinician programmer and print out a