Integra Licox REF IT2 Gebrauchsanleitung Seite 7

Magnetic Resonance Imaging (MRI)
Safety Information:
MRI Safety of the Licox IT2/IT2EU Complete
Brain Tunneling Probe Kit:
Including the REF CC1P1 Combined
Oxygen and Temperature
REF VK52 Parenchymal Probe Guide at 1.5
Tesla.
The Licox IT2/IT2EU Complete Brain
Tunneling Probe Kit has been found to
be MR Conditional under the following
conditions ONLY:
• 1.5 Tesla -active shielded
• A Body RF coil was used to transmit and
receive RF energy at 64MHz
• 1 G/cm Maximum Spatial Gradient
• Whole body SAR 1.0 W/kg in the head
or body during the MRI procedure.
MR Conditional is defined in the ASTM
F2503 Standard, Standard Practice for
Marking Devices and Other Items for Safety
in the Magnetic Resonance Environment
as: "an item which has been demonstrated
to pose no known hazards in a specified
MR environment with specified conditions
of use".
WARNINGS
These guidelines apply to MRI procedures
conducted using 1.5 Tesla MR System,
ONLY.
Testing has not been performed on other
MR Systems and therefore should not be
used.
Use only normal operating mode. Do not
perform MR scans in the 1st level or higher
level control mode.
Disconnect all cables and patient monitoring
devices from the Licox CC1P1 probe prior
to entering the MRI environment. Failure
to do so may result in serious injury to the
patient. It is not possible to monitor brain
oxygen tension during MRI procedures
using this device.
The position or orientation of the Licox
CC1P1 probe and VK52 Parenchymal
Probe Guide does not impact their MRI
Safety characteristics.
DO NOT EXCEED AN
FREQUENCY) WHOLE BODY AVERAGED
SAR (SPECIFIC ABSORPTION RATE)
OF 1.0 W/ Kg IN THE HEAD OR BODY
DURING THE MRI PROCEDURE.
OVERVIEW
The Licox IT2/IT2EU Complete Brain
Tunneling Probe Kit including the REF
CC1P1 Combined Oxygen and Temperature
Probe and REF VK52 Parenchymal Probe
Guide were subjected to MRI testing,
Probe and
which included radio frequency induced
heating, magnetically induced displacement
force and torque to demonstrate that
these components were considered "MR
Conditional" as defined in ASTM F2503,
Standard Practice for Marking Medical
Devices and Other Items for Safety in the
Magnetic Resonance Environment using in a
1.5 Tesla MRI System, ONLY. Testing has not
been performed on other MR Systems and
therefore should not be used.
The
Tunneling Probe Kit including the REF
CC1P1 Combined Oxygen and Temperature
Probe and REF VK52 Parenchymal Probe
Guide have undergone extensive laboratory
testing to demonstrate that, by following
specific guidelines, it is safe to perform an
MRI procedure on a patient with an implanted
probe using a 1.5 Tesla MR system, ONLY.
However,
systems, differences in how they calculate
specific absorption rates (SARs) and the
characteristics of each MR system's installation
cannot be simulated comprehensively in the
laboratory environment.
This
guidelines and specific conditions under
which the Licox IT2/IT2EU Complete Brain
Tunneling Probe Kit has been shown to
pose minimal risk to a patient undergoing
an MRI procedure.
Deviation from these guidelines may increase
the potential for serious harm to the patient.
MRI conditions utilizing MR systems with
higher or lower static magnetic fields have
not been assessed for the Licox IT2/IT2EU
Complete Brain Tunneling Probe Kit and,
as such, must be avoided to ensure patient
safety.
MRI - Licox IT2/IT2EU INTERACTIONS
MRI INDUCED HEATING -
Under certain conditions, RF fields generated
by MRI can induce substantial currents
in metallic components contained within
RF (RADIO
medical device products. This may rapidly
produce significant heating of a device.
Failure to follow the recommendations
contained in this communication may result
in the generation of thermal lesions and
serious patient harm.
Licox IT2/IT2EU
variability among
document outlines
Complete Brain
other MR
recommended
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