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Vectra® Neo Clinical Therapy System
APPENDIX 3
CALCULATIONS FOR OUTPUT CURRENT
The Vectra® Neo Clinical Therapy System controls total output current and output energy to comply with IEC 60601-2-
10. The System also controls total output current density for the selected electrode to comply with FDA requirements.
The Vectra® Neo Clinical Therapy System controls output by dynamically changing the range of controllable/selectable
parameters, based on the user selection of Intensity, Phase Duration, Frequency, and/or Electrode size.
The following tables provide the calculation and guidance used by the system to dynamically control the output and
comply with IEC 60601-2-10 and the 250 mW/cm2 power density-limit required by FDA. All calculations are based on
Resistive Load = 500 ohms and Accuracy of 10% (1.1).
CC: Constant Current
CV: Constant Voltage
Waveform
IEC current
limit
(in mA)
Output current equation
[I
RMS
in mA]
Intensity [I]
(in mA (CC), in
V (CV))
Phase Duration
[T]
(in uSec)
Frequency [F]
(in Hz)
Duty Cycle [D]
Number of
Pulse [N]
Interferential (F <= 5 kHz) (CC)
100
ܫ כ ܽܿܿݑݎܽܿݕ
ξʹ
0 – 100
50 – 250
2000 – 10000
100%
N/A
Interferential (F > 5 kHz) (CC)
100
ܫ כ ܽܿܿݑݎܽܿݕ
0 – 90
50 – 250
2000 – 10000
100%
N/A
Interferential (F <= 5 kHz) (CV)
100
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ
ξʹ
0 – 64
50 – 250
2000 – 10000
100%
N/A
Interferential (F > 5 kHz) (CV)
100
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ
0 – 45
50 – 250
2000 – 10000
100%
N/A
Premodulated (F <= 5 kHz) (CC)
100
ܫ כ ܽܿܿݑݎܽܿݕ
ʹ
0 – 100
50 – 250
2000 – 10000
66%
N/A
Premodulated (F > 5 kHz) (CC)
100
ܫ כ ܽܿܿݑݎܽܿݕ
ξʹ
0 – 100
50 – 250
2000 – 10000
66%
N/A
Premodulated (F <= 5 kHz) (CV)
100
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ
ʹ
0 – 96
50 – 250
2000 – 10000
66%
N/A
Premodulated (F > 5 kHz) (CV)
100
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ
ξʹ
0 – 68
50 – 250
2000 – 10000
66%
N/A
Russian (CC)
100
ܫ כ ܽܿܿݑݎܽܿݕ כ ξܦ
ξʹ
0 – 100
200
2500
50%
N/A
Russian (CV)
100
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ כ ξܦ
ξʹ
0 – 90
200
2500
50%
N/A
VMS™ (CC)
50
ܫ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 200
20 - 1000
1 – 200
100%
2
VMS™ (CV)
50
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 200
20 - 1000
1 – 200
100%
2
VMS™ Burst (CC)
50
ܫ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 200
20 – 700
1 – 200
100%
6
VMS™ Burst (CV)
50
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 200
20 – 700
1 – 200
100%
6
VMS™ FR (CC)
50
ܫ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 150
20 – 400
20 – 80
100%
2
VMS™ FR (CV)
50
ሺܫȀܴሻ כ ܽܿܿݑݎܽܿݕ כ ξܰ כ ξܨ כ ξܶ
ͳͲͲͲ
0 – 150
20 – 400
20 – 80
100%
2
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