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4. Treatment methods > 4.5. Temperature monitoring
Fig. 19: If the sonication is estimated to induce heat close to the risk level,
the software displays one of the above warnings (depending on risk level),
and the user is asked to confirm the start of the sonication.
NOTICE
Variations in the patient's anatomy and physiology, environmental conditions, etc., affect the
heating and cooling of the tissue. The system will not be able to detect all the possible cases in
which there is a risk of skin burn. Treatment decisions need to be made based on clinical
consideration of the potentially contributing factors.
4.5.4. Cooling time
Each sonication is followed by a cooling time. Cooling is necessary to prevent tissue burns in the
near field. Cooling time depends on the currently chosen parameters for the next sonication,
including cell size, type, power, frequency, etc. It is also affected by the sonication history and post-
sonication fat-monitoring scans, when available. Cooling time increases when the planned cell size
increases, when power increases, when energy increases, or when the cell is placed closer to the
skin.
The system enforces a mandatory cooling time that cannot be overridden, to prevent immediate
burn due to a single sonication or due to the next few sonications.
The recommended cooling time can be overridden by the user, because the treating physician
may have additional clinical information about the treatment or the patient that convinces the
physician that treatment speed can be increased without compromising patient safety.
A high-risk warning is displayed for aggressive overrides that involve a high risk of burns due to
a single sonication or due to the next few sonications.
It is not recommended to start the next sonication until the entire system-recommended cooling
time has passed.
The post-sonication temperature scan cannot be stopped from the Sonalleve console, only from
the MR scanner console. Stopping the scan is not advisable.
After the post-sonication temperature monitoring scan, the system may start a fat-monitoring
scan to collect information for improving the cooling time estimates. This scan cannot be
stopped from the Sonalleve console, only from the MR scanner console. Stopping or preventing
the scan is not advisable.
Use of the beam shaping feature or electronic deflection increases near-field heating. In these
situations it may be necessary to use longer cooling times than recommended by the Sonalleve
system.
Instructions for Use
109745C2 / 02-2022
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