Monteris Medical Neuroblate, Инструкция по эксплуатации

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NeuroBlate® System Instructions for Use
80469 Rev D – Nov 16, 2018
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CAUTION: During treatment near the brain surface, near bone, near large volumes of
CSF, or near large blood vessels: Due to the non-homogenous conduction of heat in this
type of anatomy, as well as the increased variability of MRI thermometry in areas of
dissimilar tissues, there is a risk of damage to these adjacent tissues. Careful planning
should be done for targets that require treatment adjacent to these tissues. Consideration
should be given to limiting the development of the thermal dosage contour line adjacent to
these structures.
When using the SideFire Laser Probe, angular orientation can be changed while delivering laser
energy by clicking the laser direction arrow and dragging it to a new orientation. This is not
relevant to the FullFire given that it is not directional.
If a new linear position is desired for continuing thermal treatment or if the MR thermal
acquisition needs to be stopped and restarted for any reason, the following steps should be
followed:
•
Stop thermal delivery by releasing the laser foot pedal
• Allow MRI to continue acquiring the NeuroBlate Thermal Monitoring Sequence to allow
all heated tissue to return to baseline temperature. For tissue adjacent to the probe,
this may require up to 120 seconds. Tissue further away from the probe may take
longer to return to baseline temperature. The Pixel Temperature Query tool and the
temperature map can be used to monitor all tissue.
Note: Internal probe tip cooling continues throughout the MR thermal acquisition even when
the laser foot pedal is released. It is only stopped when receipt of MR thermal data stops or
whenever a system fault occurs which immediately disables the laser and cooling functions.
WARNING: When a system fault occurs, cooling is turned off to ensure patient safety until
the cause of the fault can be addressed and the system restarted. However, this means
there is no active cooling and tissue may take longer to return to baseline temperature. It is
important that you keep the MRI running until the tissue has cooled to baseline, as this will
result in correctly calculated thermal dose. Failure to keep the MRI running may result in
the inaccurate calculation of thermal dose levels which may lead to patient injury.
If the MRI acquisition was halted prior to tissue returning to baseline, ensure the probe tip
temperature returns to baseline temperature prior to re-initiating MR scanning, probe cooling
or laser ablation.
•
Stop acquiring the NeuroBlate Thermal Monitoring Sequence on the MRI and select
Stop Acquisition under the Monitoring Status heading on the M*Vision right menu bar