FujiFilm VisualSonics Vevo MD User Manual page 376

Noise on a waveform or artifacts
l
displayed numerical value that cannot be attributed to a physiological effect and
that may alter the diagnosis
Display of incorrect numerical values associated with the diagnosis to be
l
performed
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
l
temperature
Production of unintended or uncontrolled motion of transducer assemblies
l
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
1 23
or distortion in an image or error of a