Enraf Nonius Endomed 482, Руководство по эксплуатации

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Output meter uncertainty : ± 20 % for any output above 10 % of maximum
Pulse frequency
: 16, 48 and 100 Hz ± 1 %
Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave)
Pulse duration : 0.5 – 8 ms ± 10 % (set by duty cycle)
Temporal Peak to Average Ratio (RTPA) :20 – 1.25 ± 10 % (set by duty cycle)
Treatment timer
: 0 - 30 min ± 0.1 min, linked to contact control
Contact control level : 65%
5 cm² Applicator
Ultrasound frequency:
1 MHz : 0.98 MHz ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm
2
21 CFR 1050.10 : 5 cm
2
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 ± 2 %
3 MHz : 3.1 MHz ± 2 %
ERA (Effective Radiation Area):
IEC 60601-2-5: 2000 : 4 cm
2
21 CFR 1050.10 : 5 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 (8.2.3.7) 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.
10.2 Stimulator output parameters
Electrotherapy general
Channels : 2
Output characteristics : Constant Current (CC) or Constant Voltage (CV), except for
High Voltage (CV) and Microcurrent (CC).
Current amplitude range : Depending on current waveform
Current amplitude resolution : 0.2 mA
Treatment timer : 0 - 60 minutes
Polarity reversion direct currents : manual