Output Specifications; Essential Performance - XBody Newave User Manual

8

Output specifications

The device uses 10 channels to stimulate 10 different muscle groups. The channels are isolated
galvanically from each other, and there is a DC/DC converter on each of the channels which operates
as a second safety barrier. The first safety barrier is an IEC 60601 approved power supply; the second
is the DC/DC converters on the channels.
8.1

Essential performance

The section describes the waveform and the calculations on the maximal outputs of the XBody
Nevawe Med machine. This section also references the requirements of the standard according to
essential performance and the referencing against their implementation in the XBody Newave.
8.1.1 Waveform
The waveform of the machine is the following:
This waveform is used for stimulation during one period of time. This is a fixed waveform that the
simulation electronics uses.
8.1.2 Stimulation parameters
The range of the impulse parameters are the following:
Name
Program time (min)
Frequency (Hz)
Impulse depth (
Impulse amplification (s)
Amplitude (V)
Impulse time (s)
Impulse break (s)
Value
0-45
0-100
0-400
0-1.1
0-50
0-10
0-10
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