Esaote O-scan eXP, User Manual

Page: 97 / 242

350004900 Rev. 07 17 / 22
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Patient Routine Monitoring Requirements
To ensure audio and visual contact between the physician and the patient
during examinations, if O-scan is installed inside a traditional shielding
booth/room, the following restrictions should be respected:
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the booth/room should be equipped with an open window space with a
grille to enable audio contact between the physician and the patient
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adequate lighting must be guaranteed inside the shielding booth, also
taking into account lighting of the room where the console is located, and
the position of the window must be in front of the O-scan installation to
ensure the visual control of the patient by the physician during the
examination.
Installation Procedure
Installation of the O-scan system must be carried out exclusively by
technical assistance personnel authorized by Esaote S.p.A., according to
the system installation procedure specified in the Service Manual.
Controlled Access Area
The user must define a controlled access area around the O-scan system,
to ensure that the magnetic fringe field outside this area does not exceed
0.5 mT and that the level of electromagnetic interference complies with
Standard EN 60601-1-2 and subsequent amendments. See chapter 3,
“Instructions for Safe Use” in this document.
Use suitable warning/prohibition labels and symbols and define adequate
rules for access to the controlled access area by patients, operators,
personnel and others in general.
Restricted public access begins at the 0.5 mT line.
The maps of the magnetic fringe are provided in the chapter “Instructions
for safe use”, paragraph “MR personnel and patient exposure to the static
magnetic field”, in this manual.
Warning labels
The presence of the magnetic field and the related potential hazards must
be indicated by a pair of standard labels (see figure below), on the front
and rear of the magnet, to be visible to all persons.
The large label must be affixed outside the controlled access area on all
access doors of the room in which O-Scan is installed.
The 0.5 mT line should also be outlined on the floor surrounding the
magnet. The material used to indicate the 0.5 mT line must be durable,
such as the yellow adhesive tape provided with the system.