Page 62 of 72 EN109-1498751-47 IFU
Beam type:
1 MHz : Collimating
3 MHz : Collimating
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum
0.8 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 5 %
3 MHz : 3.1 MHz ± 5 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 0.6 cm
2
21 CFR 1050.10 : 0.8 cm
2
Beam type:
1 MHz : Collimating
3 MHz : Diverging
BNR (Beam Non-uniformity Ratio) : 6:1 maximum
Side radiation : 10 mW/cm² maximum
Description of ultrasound area
The spatial distribution of the radiated field is a collimated beam (diverging for the 0.8 cm² applicator
at 3 MHz) of ultrasound energy, with a decreasing Amplitude at increasing distance from the
applicator surface. This field distribution applies to the radiation emitted into the equivalent of an
infinite medium of distilled, degassed water at 30 ºC and with line voltage variations in the range of ±
10% of the rated value. The ultrasonic beam is characterized by the Effective Radiation Area (ERA) and
the Beam Non-uniformity Ratio (BNR).
The Effective Radiation Area is the cross-sectional area of the ultrasound beam. Its value can be set
under System Settings and depends on the ultrasound standard used:
• International: IEC 60601-2-5:2000
• USA: 21 CFR 1050.10
The Beam Non-uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average
ultrasound Amplitude, measured at the Effective Radiation Area. A low BNR value is indicative for the
absence of high and potentially dangerous energy concentrations.
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