A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y
MyLab
- G E T T I N G S T A R T E D
2 - 8
Recommended Distances between Radiofrequency (RF)
Communication Systems and MyLab
It is recommended not to use radiofrequency (RF) transmission systems near
the ultrasound scanner. RF systems can cause interference, which alters the
echographic image and Doppler traces.
The operator can prevent interference caused by electromagnetic fields by
maintaining a minimum distance between the ultrasound scanner and the RF
communication systems being used (for example cell telephones, mobile
telephones).
The following degradation shall not be allowed:
the disturbance shall not produce noise on a waveform,
artefacts, distortion in an image or error of a displayed
numerical value which cannot be attributed to a physiological
effect and which may alter the diagnosis;
the disturbance shall not produce an error displaying
inaccurate numerical values associated with the diagnosis to
be performed;
the disturbance shall not produce an error displaying
inaccurate safety-related indications;
the disturbance shall not produce unintended or excessive
ultrasound output;
the disturbance shall not produce unintended or excessive
transducer assembly surface temperature.
MyLab
, according to the definition of the IEC 60601-1-2 ed. 4 standard is
suitable to be installed in professional healthcare facility environment.
The operator must remember that the intensity of the electromagnetic fields
generated by fixed transmitters (for example radio-base stations for cellular or
cordless telephony, TV and radio transmissions, amateur radio transmissions)
cannot be predicted on a theoretical basis. Consequently, a direct measure
may be necessary in the use environment of a
MyLab
. If the intensity of the
electromagnetic fields exceeds that one specified in the immunity levels
shown in the previous tables, and the ultrasound scanner performs
incorrectly, additional measures may be necessary, for example by positioning
the ultrasound scanner in a different way.
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