Safety Device (Sd) - Profound Sonalleve MR-HIFU Instructions For Use Manual

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2. Safety > 2.5. Emergency Stop and Safety Devices
NOTICE
Instruct the patient on how and when to use the patient emergency stop button (PESB). Such
situations include:
Sudden pain during the procedure.
Skin heating.
Numbness in legs or other body parts.
Nausea.
Cardiac symptoms.

2.5.2. Safety Device (SD)

The operator can terminate the treatment at any point using the Safety Device. Use the Safety
Device to stop the treatment if you detect a hazardous situation as an undesired heating pattern, or
a malfunction in the equipment. The Safety Device provides the following functions:
Audio signal to indicate that:
-
the patient has pressed the PESB, or
-
the PESB has been disconnected.
Sonication ON audible indicator – An audible beeping sound is emitted from the Safety Device
when the ultrasound transducer is emitting acoustic energy. A sound level switch is located
underneath the device.
Green Enable button – Pressing this button enables the ultrasound electronics. Sonication is
only possible when the button is lit. The green light will blink during sonication.
Red Stop button – The Stop button is lit when the ultrasound electronics are disabled and
sonication is not possible. The Stop button can be used at any time to disable the ultrasound
electronics and to suppress the audio signal.
Instructions
for
Use
109745C2 / 02-2022
Fig. 1: The Safety Device.
19 (192)

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