107
Interference
immunity test
IEC 60601 test level
Compliance level
Electromagnetic
environment direct
ive
Voltage drops, short
interruptions and fluc
tuations of the supply
voltage according to
IEC 61000-4-11
< 5 % U
T
(> 95 % drop of U
T
)
for 1/2 period
40 % U
T
(60 % drop of U
T
) for
5 periods
70 % U
T
(30 % drop of U
T
) for
25 periods
< 5 % U
T
(> 95 %
drop of U
T
) for 5 s
N/A
The quality of the sup
ply voltage should be
equivalent to a typical
commercial or hospital
supply. If the user of
the product 'Genium
X3 - Bionic Prosthetic
System 3B5-X3 /
Genium X3 3B5-2'
demands continuous
operation even in case
of an interruption in
the supply voltage, we
recommend supplying
the product 'Genium
X3 - Bionic Prosthetic
System 3B5-X3 /
Genium X3 3B5-2'
with an uninterruptible
power supply or bat
tery.
Magnetic field at
mains frequency
(50/60 Hz) according
to IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields at the
mains frequency
should be equivalent
to the typical levels for
commercial or hospital
environments.
Note: U
T
is the rated voltage before applying the test levels.
Table 4 – Electromagnetic interference immunity for non-life-sustaining devices and sys
tems
Directives and manufacturer's declaration – electromagnetic interference immunity
The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for
operation in an electromagnetic environment as specified below. The customer or user of the
product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' must ensure that
the device is operated in such an environment.