Dome Ex Display, Руководство пользователя

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8 | Dome Ex Display
The Dome Ex display is an AMLCD display designed for viewing
medical X-ray images. This unit should not be used near patients and
should be kept outside of 1.5 m perimeter and 2.29 m vertical.
Intended use
Dome Ex line, model Dome E2cHB is intended for use in the
displaying and viewing of medical images for review, analysis, and
diagnosis by trained medical practitioners.
For the European market, Dome Ex line, model Dome E3 is intended
for use in the displaying and viewing of radiography images for
review, analysis, and diagnosis by trained medical practitioners.
Dome Ex line, model Dome E3cHB is intended for use in the
displaying and viewing of medical images for review and analysis by
trained medical practitioners.
Dome Ex line, model Dome E5 is intended for use in the displaying
and viewing of medical images, including radiographs of the breast,
for review and analysis by trained medical practitioners.
WARNING! In the Dome Ex display series, only the Dome E5 display
can be used for primary image diagnosis in mammography. The
Dome E2cHB, Dome E3, and Dome E3cHB units must not be used for
primary image diagnosis in mammography.
Federal law restricts this device to sale by or on the order of
a medical practitioner.
Safety precautions
External equipment intended for connection to signal input, signal
output, or other connectors, must comply with the relevant IEC
standard (IEC 60601-1:2005 and EN 60601-1:2006 series for medical
electrical equipment). In addition, all such combinations (systems)
must comply with the standard IEC 60601-1:2005,
Safety
requirements for medical electrical systems.
Equipment not complying to IEC 60601-1:2005 must be kept outside
the patient environment, as defined in the standard as at least 1.5
meters from the patient or the patient support.