User Manual MUT_RD_009H_GB Page
16
of 43
input electrical feed
lines
IEC 61000-4-11
40 %
U
T
(60 % dips of
U
T
)
during 5 cycles
70 %
U
T
(30 % dips of
U
T
)
during 25 cycles
<5 %
U
T
(>95 % dips of
U
T
)
during 5 s
Complies
Complies
Complies
operation during the mains supply
failure, it is recommended to feed the
EyeOP1 control unit from a failure-free
energy supply or from a battery.
Magnetic field at the
mains supply
frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m
Complies
The magnetic fields at the mains supply
frequency must feature the specific
levels
of a representative location in a
typical
commercial
or
hospital
environment.
Note:
U
T
is the voltage of the AC power supply before application of the test level.
Directives and manufacturer’s claim
–
electromagnetic immunity
The medical device is intended for use in the electromagnetic environment described below. The
customer or medical device user must ensure that it is used in such an environment.
Immunity
testing
Test level
as per IEC
60601
Compliance
level
Electromagnetic environment - directives
Conducted
RF emissions
IEC 61000-4-
6
Radiated RF
emissions
IEC 61000-4-
3
3 Veff
from 150
kHz to 80
MHz
3 V/m
from 80
MHz to
2.5 GHz
3 V
3 V/m
The RF communication mobile devices should not be
used closer to any part of the medical device (including
cables) than the recommended separation distance,
calculated from the equation applicable to the
transmitter frequency.
Recommended separation distance:
d
= 1.17
√𝑃
d
=
1.17
√𝑃
80 MHz to 800 MHz
d = 2.34
√𝑃
from 800 MHz to 2.5 GHz
where
P
is the transmitter maximal power output in
watts (W), according to the transmitter manufacturer
and
d
is the recommended separation distance in meters
(m).