Esaote O-scan eXP, User Manual

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350004900 Rev. 07 45 / 48
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Instructions for Safe Use
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O-scan is non-protected with respect to harmful ingress of water.
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O-scan is not designed for use in the presence of an anesthetic
flammable mixture with air or oxygen or with nitrogen protoxide.
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O-scan complies with the EN 60601-1-1 Standard and subsequent
amendments.
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O-scan complies with the EN 60601-1-2 Standard and subsequent
amendments.
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Parts of the O-scan system that come into contact with the patient
comply with standard EN ISO 10993-1 and subsequent amendments, in
the category of devices subject to superficial contact of limited duration
( d 24 h).
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O-scan complies with the EN 60601-1-4 Standard and subsequent
amendments.
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O-scan complies with the EN 60601-1-6 Standard and subsequent
amendments.
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O-scan complies with the EN 60601-2-33 Standard and subsequent
amendments, and operation mode is Normal Operating Mode.
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O-scan complies with the EN 14971 Standard and subsequent
amendments.