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4. Treatment methods > 4.2. Patient selection
Treatment cell
safety margin
Treatment
plane
Treatment
point
Ultrasound
beam path
4.2. Patient selection
Patients with any of the following conditions are not suitable for treatment with the Sonalleve MR-
HIFU system:
MRI contrast agent contraindications.
Scars that cannot be protected or surgical clips, implants, or prosthesis in the planned path
of the ultrasound beam (for more information on protection methods, see 6.6.7. Beam
shaping) .
Target <1 cm from growth plate, nerve plexus, spinal canal, bladder, bowel, or other
sensitive structures or organs
Inability to tolerate stationary position for the duration of the procedure
Patient's weight > 140 kg (308 pounds).
NOTICE
If a patient has a history of liposuction, they may have scars in the abdomen that are not visible
outside. In such cases, the patient's eligibility for treatment must be assessed clinically by a
medical professional.
NOTICE
General or local clinical protocols may present patient selection and exclusion criteria differing
from, and overriding the criteria listed above. Always consult the relevant protocols when making
decisions related to patient selection.
4.3. Sonication method
In the regular sonication method, the ultrasound beam treatment point sonicates points along its
path with a constant power level for a predefined time.
The feedback sonication method aims to minimize the time used per treatment cell. This method
divides the trajectory of the treatment point into several smaller areas, or sub-trajectories, which
are sonicated one-by-one at a constant power. When a sub-trajectory reaches a certain
predefined temperature and/or thermal dose, the treatment point moves onto the next sub-
trajectory.
Instructions for Use
109745C2 / 02-2022
Lines displayed around a treatment cell to visualize its advised minimum
distance from sensitive tissues.
The plane on which the treatment cells in a cluster are located. The center of
each treatment cell is in this plane.
The point where ultrasound heating is centered at a specific moment of time.
The volume through which the acoustic waves travel from the transducer.
Also called the transducer beam.
48 (192)
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