Protecting The Equipment Against Liquids - Profound Sonalleve MR-HIFU Instructions For Use Manual

2. Safety > 2.9. Protecting the equipment against liquids
WARNING
Avoid touching the patient or objects connected to the patient during the procedure.
Touching increases the risk of exposure to potentially hazardous leakage currents.
NOTICE
If there are other persons such as a support person of the patient in the RF room during therapy,
the rationale should be explained to the patient and to the additional persons.
WARNING
To avoid risk of electric shock, this equipment must only be connected to a mains supply
with a protective earth.

2.9. Protecting the equipment against liquids

The HIFU treatment requires an acoustic contact liquid to be used between the gel pad and the
patient and on the membrane. Use disposable sheets to absorb any spilled liquid.
Do not allow liquids to enter any other part of the Sonalleve MR-HIFU equipment. Before each
treatment, visually check that the Sonalleve Table Top is not leaking.
WARNING
Daily inspect the Sonalleve MR-HIFU system and the magnet for leaks. The Sonalleve Table
Top houses a liquid container. Do not connect the Sonalleve System Cables if you find a
leak. If a leak occurs during treatment:
• Terminate the sonication immediately using the Stop button of the Safety Device.
• Remove the patient from the Table Top.
• Identify the reason for the leak.
• To prevent further damage, remove the leaking part from the RF room.
• Do not continue scanning or treatment until a qualified service engineer or equivalent has
examined the scanner and the Sonalleve MR-HIFU system.
A failure to follow these instructions may expose the patient or an operator to a risk of an
electric shock.
Instructions for Use
109745C2 / 02-2022
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