Emergency Stop And Safety Devices; Patient Emergency Stop Button (Pesb) - Profound Sonalleve MR-HIFU Instructions For Use Manual

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2. Safety > 2.5. Emergency Stop and Safety Devices

2.5. Emergency Stop and Safety Devices

There are three abort mechanisms in the Sonalleve MR-HIFU system:

Patient Emergency Stop Button (PESB) for the patient.

A Stop button in the Safety Device for the user.

An abort button in the user interface.

WARNING

Use the Safety Device Stop button or PESB immediately in a hazardous situation. Use the

software abort button to stop the sonication in situations that do not present any hazard (if,

for example, the treatment is deemed sufficient before the planned treatment time is

reached).

The patient can stop the treatment at any point by pressing the Patient Emergency Stop Button

(PESB). Pressing the PESB terminates the sonication immediately, although scanning of the

temperature maps continues. As the patient presses the button, an indicator light is switched on in

the device, there is a beep sound in the MR room and in the operator's Safety Device, and the

Sonalleve Console displays an error. Always instruct the patient about the correct usage of the

PESB prior to the start of the treatment. If the patient has stopped the treatment because of pain,

analyze the cause of pain before continuing the treatment.

When the patient presses the PESB, the red indicator light in the Safety Device is switched on. No

further sonications are possible, before the user presses the green Enable button in the Safety

Device.

During pre-treatment scanning, and when sonication is not on, the PESB functions like the MR

nurse call button: it gives an audio signal but does not stop scanning.

WARNING

Do not use the standard MR Nurse Call button with the Sonalleve MR-HIFU system. Use the

Patient Emergency Stop Button (PESB) instead.

Instructions for Use

109745C2 / 02-2022

18 (192)

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