FujiFilm VisualSonics Vevo F2 User Manual page 463

Electromagnetic interference
The Vevo F2 Imaging System should never be used where safety could b e affected by the
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malfunction of medical devices.
The Vevo F2 Imaging System is designed for use in preclinical laboratories and is not c leared for use
with or in the vicinity of active medical devices. High levels of e lectromagnetic energy may interfere
with the operation of the Vevo F2 Imaging System. F urthermore, the Vevo F2 Imaging System could
affect the safe operation of sensitive m edical devices.
The Vevo F2 Imaging System system has been found to temporarily lose touch screen functionality
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during 430 kHz~2 MHz common-mode noise injection on the AC mains. FUJIFILM VisualSonics
recognizes the system's sensitivity to this kind of noise and assures users that such a loss of the
touch screen capability doesn't affect core ultrasound imaging functionality of the system. This
phenomenon is qualified as permissible loss of performance for the Conducted Immunity test as per
IEC 61326-1:2012, Table 1.
To avoid the risk of increased electromagnetic emissions or d ecreased immunity, use only
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accessories and peripherals recommended by F UJIFILM VisualSonics. Connection of accessories
and peripherals not recommended by F UJIFILM VisualSonics could cause your ultrasound system
to malfunction, or cause other medical e lectrical devices in the area to malfunction.
The use of accessories, transducers and cables other than those s pecified (with the exception of
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transducers and cables sold by FUJIFILM VisualSonics as r eplacement parts for internal
components) may result in increased emissions or d ecreased immunity of the Vevo F2 Imaging
System.
DO NOT situate the Vevo F2 Imaging System close to large clinical m agnets, as the magnetic fields
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may affect performance a nd c ause distortions in the acquired image.
Chemicals
If any part of the Vevo F2 Imaging System is in contact with hazardous c hemicals or biological
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materials, appropriate precautions must be taken by all who c ome into contact with the Vevo F2
Imaging System until the device is declared completely f ree of harmful contamination.
Radiation
The use of controls or adjustments or performance of procedures in w ays other than those specified
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in this manual may result in hazardous radiation e xposure.
HDMI Video Output
FUJIFILM VisualSonics recommends against using a monitor other than the image display provided
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by FUJIFILM VisualSonics. Only the images presented on the image display are validated for the
intended use of the device.
For added protection, use an isolation transformer between the connecting device and AC power.
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Reference
Vevo F2 Imaging System User Manual
463