Integra Licox REF IT2 Gebrauchsanleitung Seite 8

MAGNETIC FIELD INTERACTIONS -
Magnetic materials
an implanted device may experience
translational attraction or rotational forces
when brought into the static magnetic
field of an MR system. The Licox CC1P1
probe contains magnetic material and
has been shown in safety testing to not
be substantially affected by translational
attraction and torque related to exposure to
a 1.5 Tesla static magnetic field of an MR
system.
IMAGE ARTIFACTS -
The presence of the Licox CC1P1 probe
will cause minor artifacts on the MR image.
It is up to the discretion of the interpreting
physician to determine if the location of the
sensor is in the area of imaging interest and
whether it will adversely affect the quality of
the diagnostic information required from the
MRI procedure.
The Licox CC1P1 connector will cause
substantial artifacts and distortion on the
MR image. As such, position the connector
away from the anatomy of interest during
the MRI procedure.
PROCEDURE - In addition to standard
safety procedures for MRI, the following
precautions must be followed specific to the
Licox IT2/IT2EU product:
1. Inform the patient of the potential risks
of undergoing an MRI procedure with
this device. Disconnect all cables and
patient monitoring devices attached to
the Licox IT2/IT2EU prior to transporting
the patient into the MRI environment.
2. Use only the
radio frequency
the MRI
receive RF body coil
Transmit body coil/receive-only head coil
Transmit/receive head coil
Transmit/receive lower extremity coil for
imaging of lower extremities only, not for
imaging the head of patients.
3. Set MRI parameters to the lowest
usable whole body averaged SAR level.
THIS MUST NOT EXCEED A WHOLE
BODY AVERAGED SAR OF 1.0 W/kg
IN THE HEAD OR BODY to minimize
the risk of excessive heating of device
components.
8
contained
following types
(RF) coils
procedure: Transmit/
4. For head scans using the transmit body
coil the local SAR must be less than
within
2.0W/kg.
5. Verify
appropriately calculated and updated
the SAR value after all parameter
changes have been made. Ensure that
the proper patient weight is used for the
SAR calculations.
6. A knowledgeable MRI expert (e.g., MRI
physicist, MRI-trained radiologist) must
verify that all set-up steps and settings
have been properly implemented and
checked prior to performing the MRI
procedure.
7. If conscious and alert, provide the patient
with a means of alerting the MRI system
operator of unusual sensations. Instruct
the patient to watch for sensations such
as overheating or shock. Terminate the
MRI procedure immediately if so notified
by the patient.
8. Monitor the patient continuously during
the MRI examination and be prepared
to stop and respond in the event of an
emergency.
of
for
that the MR system has