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1. Introduction to Sonalleve MR-HIFU > 1.4. Operator profile
Very rare effects
Exceptional effects
1.4. Operator profile
The Sonalleve MR-HIFU operator can be a person with professional qualifications for and
experience in MR imaging. All operators treating patients with Sonalleve MR-HIFU must have
received training by Profound Medical in the safe use of the system.
In addition, hospital technicians, clinical scientists, application specialists and service personnel
who have attended Sonalleve MR-HIFU training may use the system for testing, upgrades,
maintenance and routine Quality Assurance (QA). For more information, see 7. Maintenance.
1.5. Compatibility
The Sonalleve MR-HIFU System is available for Philips Achieva and Ingenia MR scanners.
The product described in this manual should not be used in combination with other products or
components unless such other products or components are expressly recognized as compatible by
Profound Medical. A list of such products and components is available from Profound Medical.
The other products and components that may be used with the system may each have their own
Instructions for Use.
Changes and/or additions to the product should only be carried out by Profound Medical or by third
parties expressly authorized by Profound Medical to do so. Such changes and/or additions must
comply with all applicable laws and regulations that have the force of law within the jurisdiction(s)
concerned, and with best engineering practice.
Instructions for Use
109745C2 / 02-2022
< 3% of
HIFU
patients
Gadolinium
Catheter
< 1% of
HIFU
patients
Third degree skin burns
Nerve injury or damage
Injury to organs near the
treatment area
Pain not reacting to drugs
Skin infections
Adverse drug reaction to Gadolinium
Urinary symptoms, such as infection
or hematuria
Other infections
Fever caused by infection
Bleeding
Metabolic imbalance (Tumor Lysis
Syndrome)
9 (192)
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