Manufacturer's EMC declaration
21
Page 34
The key features of Opton include: delivering laser radiation for therapeutic purposes, as well as trouble-free operation of all
functions.
Guidelines and manufacturer's declaration of electromagnetic immunity
The Opton device is intended for use in the electromagnetic environment specified below. The customer or user of the Opton
device should ensure that it is used in such an environment.
Immunity
tests
IEC 60601 - Test
Levels
Conformity level
Electromagnetic environment guidelines
Conducted
RF
interference
per IEC
61000-4-6
Radiated RF
disturbances
per 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
3 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the Opton,
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 = 1.17
√
P for 80MHz to 800 MHz
d = 2.33
√
P for 800 MHz to 2.5 GHz
P is the nominal rating of the transmitter in watts (W)
according to the transmittermanufacturer and d is
the recommended separation distance in metres
(m).
The field strength of stationary radio transmitters
measured on-site for all frequencies
a
should be less
than the conformity level.
b
In the vicinity of devices marked with the following
symbol, errors may occur:
NOTE 1 At 80 Hz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all cases. The electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the Opton device is used exceeds the applicable RF compliance level given
above, the Opton device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Opton device.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 204 per EN 60601-1-2
