Mri Safety Information - Integra Camino Flex Ventricular VTUN Mode D'emploi

MRI SAFETY OF THE CAMINO FLEX VENTRICULAR CATHETER
MR Conditional

MRI SAFETY INFORMATION

Non-clinical testing has demonstrated the
Camino Flex Ventricular Catheter is MR
Conditional. A patient with this device can be
safely scanned in an MR system meeting the
following conditions:
• Static Magnetic Field of 1.5 Tesla (T) and
3.0T.
• Maximum spatial gradient magnetic field of
3500G/cm (35T/m).
• Maximum MR system reported, whole
body averaged specific absorption rate
(SAR) of <2W/kg (Normal Operating
Mode).
• Under the scan conditions defined above,
the Camino Flex Ventricular Catheter is
expected to
temperature rise of less than 0.4˚C after 15
minutes of continuous scanning.
• Additional instructions
essential to safe use in the MR environment
can be located following the image artifact
information below.
• In non-clinical testing, the image artifact
caused by
approximately 3.1mm from the catheter
when imaged with a spin echo pulse
sequence and a 1.5T MRI system, and
1.85mm from the catheter when imaged
with a spin echo pulse sequence and a
3.0T MRI system. (See Fig. 5-10)
• In non-clinical testing, the image artifact
caused by
approximately 5.4mm from the catheter
when imaged with a gradient echo pulse
sequence and a 1.5T MRI system and
5.9mm from the catheter when imaged
with a gradient echo pulse sequence and
a 3.0T MRI system.
• Imaging employing
sequences is not recommended because
of the greater image artifact generation as
compared to Spin Echo sequences.
Read and understand this document in its entirety before conducting
a Magnetic Resonance Imaging procedure on a patient with an
implanted Camino Flex Ventricular Catheter (Catheter). Failure to heed
these Warnings and adhere to the Conditions For Safe Use may result
in serious injury to the patient.
produce a maximum
or information
the device extends
the device extends
Gradient
WARNINGS:
• Patient injury may occur if the
Conditions for Safe Use of the Catheter
in the MRI Environment are not
followed. Heating of greater than 4˚C is
possible for any other configuration
than
configuration.
• Do not use Head Transmit Surface
Coils.
• Do not exceed a MR system reported,
whole
absorption rate (SAR) of 2.0 W/kg,
Normal Operating Mode only.
• Do not bring any catheter accessories
(trocar, stylet, drill bit, drill stop, drill
stop or hex wrench) into the MRI
environment.
equipped operating suites.
• Immediately abort the scan should the
recommended configuration (coiled) of
the catheter comes loose. If possible,
instruct the patient to report a loose coil
configuration.
Echo
the recommended
body averaged
This includes
coiled
specific
MR-
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