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EN109-1631750-48 IFU
Ultrasound Parameters
Generator
Duty cycle
5
–
50 %
Duty cycle
80 %
Duty cycle
100 %
Peak output Amplitude:
0
–
3 W/cm²
0
–
2.5 W/cm²
0
–
2 W/cm² (continuous
wave)
Peak output power for
5 cm² applicator:
0
–
15 W
0
–
12 W
0
–
10 W (continuous
wave)
Peak output power for
0.8 cm² applicator:
0
–
2.4 W
0
–
2 W
0
–
1.6 W (continuous
wave)
Output meter uncertainty
: ± 20 % for any output above 10 % of maximum
Pulse frequency
: 16, 48 and 100 Hz ± 1 %
Duty cycle pulsed
: 5
–
80 %
Pulse duration at 100 Hz
: 0.5
–
8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) : 20
–
1.25 ± 5 % (set by duty cycle)
Treatment timer
: 0 - 30 min ± 0.1 min, linked to contact control
Contact control level
: 65%
5 cm² Applicator
0.8 cm² Applicator
Ultrasound frequency:
1 MHz:
3 MHz:
0.98 MHz ± 5 %
0.98 MHz ± 5 %
3.1 MHz ± 5 %
3.1 MHz ± 5 %
0.98 MHz ± 5 %
3.1 MHz ± 5 %
ERA (Effective Radiation Area):
IEC 60601-2-5
21 CFR 1050.10
4 cm² ± 20%
5 cm² ± 20%
0.6 cm² ± 20%
0.8 cm² ± 20%
Beam type:
1 MHz:
3 MHz:
Collimating
Collimating
Collimating
Diverging
BNR
(Beam Non-Uniformity Ratio)
6:1 maximum
6:1 maximum
Side radiation
10 mW/cm² maximum
10 mW/cm² maximum
