96
Manufacturer's EMC declaration
29
Fundamental performance characteristics of the Soleo SonoStim / Soleo Stim (stimulation current only)
are: interference-free output of stimulation current and ultrasound with the specified parameters and
interference-free operation of all functions.
Guidance and manufacturer's declaration – electromagnetic immunity
The Soleo SonoStim / Soleo Stim is intended for use in one of the electromagnetic environments specified below. The
customer or the user of the Soleo SonoStim / Soleo Stim device should ensure that the device is used in such an
environment.
Immunity
tests
IEC 60601 test level Compliance level
Electromagnetic environment – Guidance
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
rms
150 kHz to 80 MHz
10 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of Soleo SonoStim
/ Soleo Stim, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter
.
Recommended separation distance:
d= 1.17 √P
d= 0.35 √P for 80 MHz to 800 MHz
d= 0.7 √P for 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in Watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
, should
be less than the compliance level in each frequency
range
b
.
Interference may occur in the vicinity of equipment
which is marked with the following symbol:
NOTE 1 At 80 Hz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
