Intended Use - Profound Sonalleve MR-HIFU Instructions For Use Manual

1. Introduction to Sonalleve MR-HIFU > 1.3. Intended use

1.3. Intended use

This Profound Medical product is intended to be installed, used and operated only in accordance
with the safety procedures and operating instructions given in this Instructions for Use for the
purpose for which it was designed. The purpose for which the product is intended is given below.
However, nothing stated in this Instructions for Use reduces users' responsibilities for sound clinical
judgment and best clinical procedure.
The Sonalleve MR-HIFU Desmoid Application is indicated for management of benign desmoid
tumors.
The system is designed to be used on patients with no MR contraindications and that fulfill the
criteria for treatment as indicated in 2.2. Contraindications and restrictions and in 2. Safety.
Installation, use and operation of this product is subject to the law in the jurisdiction in which the
product is being used. Users must only use and operate the product in such ways that do not
conflict with applicable laws, or regulations, which have the force of law.
Uses of the product for purposes other than those intended and expressly stated by the
manufacturer, as well as incorrect use or operation, may relieve the manufacturer (or its agent)
from all or some responsibility for resultant non-compliance, damage or injury.
The intended use is subject to regulatory approval and can have country-specific limitations.
Instructions for Use
109745C2 / 02-2022
General symbol for WARNINGS and CAUTIONS
Crushing of hands
Electricity
Laser beam
Magnetic field
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