FujiFilm VisualSonics Vevo MD, Руководство пользователя

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l
Noise on a waveform or artifacts
1 23
or distortion in an image or error of a
displayed numerical value that cannot be attributed to a physiological effect and
that may alter the diagnosis
l
Display of incorrect numerical values associated with the diagnosis to be
performed
l
Display of incorrect MI/TI indications
l
Display of incorrect safety related indications
l
Production of unintended or excessive ultrasound output
l
Production of unintended or excessive transducer assembly surface
temperature
l
Production of unintended or uncontrolled motion of transducer assemblies
intended for intracorporeal use
1
Degradation of the performance of the system was recorded during the tests. Indirect Contact discharge
on VCP at ±4kV & ±6kV and direct contact discharge on the metal enclosure at ±4kV & ±6kV affected the
display and control panel. The Vevo MD Imaging System recovered on its own after the test. The EUT met
the performance level specified by the manufacturer (61000-4-2).
2
Degradation of the performance of the system was noted during the tests. The image was affected
between 80-100MHz and the Vevo MD Imaging System recovered on its own after the test. The EUT met
the performance level specified by the manufacturer (61000-4-3).
3
The control panel and clinical display was flickering during the test on AC Mains and foot pedal switch, but
the Vevo MD Imaging System recovered on its own after the test. The EUT met the performance level
specified by the manufacturer (61000-4-4).
376 Appendices