Esaote O-scan eXP, User Manual

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350004900 Rev. 07 3 / 48
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Instructions for Safe Use
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The audio visual condition to allow routine monitoring and medical
supervision of the patient.
Use environment
The use environment is intended as the actual conditions and settings in
which users interact with the medical device.
O-scan is designed to be used:
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in public or private hospital environments
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in medical studios located in commercial environments and
environments used for domestic purpose.
Controlled Access Area
The user must define a controlled access area around the O-scan system,
so that outside this area:
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the magnetic fringe field does not exceed 0.5 mT
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the level of electromagnetic interference complies with Standard
EN 60601-1-2 and subsequent amendments.
The User is further advised to use warning and prohibitive signs and labels
and establish adequate rules for the controlled access area for patients,
operators and others, to appropriately restrict entry.
Restrictions to public access start from the controlled access area limits.
The controlled access area restrictions are important safety measures:
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to reduce exposure of patients and others to risks associated with the
O-scan magnetic field
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to prevent the introduction of ferromagnetic objects or tools
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to prevent the use of peripheral equipment that is not recommended for
use in the controlled access area.
It is the user's responsibility to ensure observation of federal, state and/or
regulations governing entry to the controlled access area.
See chapter “Installation” in this manual.
W a r n i n g
O-scan is not intended to be used in emergency situations outside a
health care or hospital environment.
O-scan is not intended to be the only diagnostic system within
emergency health care departments or hospital or medical studios.