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2. Safety > 2.2. Contraindications and restrictions
When using the system for volunteer scanning, place another thin positioning pad, a thick towel or
cloth on top of the protectively used large positioning pad or absorption pad to prevent skin contact.
Do not place the absorption pad or the large positioning pad in the ultrasound beam, the pads can
become burning hot if exposed to ultrasound.
CAUTION
In training and QA sessions, only sonicate a QA phantom or other absorbing material that is
in good contact with the ultrasound window.
Acoustic energy may be reflected from unsuitable targets and interfaces such as the liquid-
air interface. The reflected energy may damage the transducer in seconds. See also 7.5.
Ultrasound protection. Do not sonicate a positioning pad on purpose.
2.2. Contraindications and restrictions
This Profound Medical product should not be used if any of the following contraindications exist or
are thought to exist:
MR contraindications specified in the MR scanner's Instructions for Use.
MRI contrast agent contraindications.
The treatment of desmoid tumors may require anesthesia or sedation. Additional
assessment is required for eligibility to anesthesia or sedation.
Scars that cannot be protected or surgical clips, implants, or prosthesis in the planned path
of the ultrasound beam
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 the evaluation of the patient's clinical situation by a physician knowledgeable of HIFU suggests
that the foreseeable treatment benefits outweigh the possible risks, the patient should be informed
about the risks and benefits and his or her consent recorded according to the local practices.
Instructions for Use
109745C2 / 02-2022
14 (192)
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