Otto Bock Genium X3 Series Instructions For Use Manual page 106

Table 2 – Electromagnetic interference immunity for all devices and systems
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.
Interference
immunity test
Electrostatic dis­
charge (ESD) accord­
ing to IEC 61000-4-2
Electrical fast transi­
ent/bursts according
to IEC 61000-4-4
Surges according to
IEC 61000-4-5
Voltage drops, short
interruptions and fluc­
tuations of the supply
voltage according to
IEC 61000-4-11
106
IEC 60601 test level
± 6 kV discharge on
contact
± 8 kV discharge
through air
± 2 kV for power lines
±1 kV for input and
output lines
±1 kV phase-to-phase
voltage
± 2 kV even voltage
< 5 % U
T
(> 95 % drop of U
T
for 1/2 period
40 % U
T
(60 % drop of U ) for
T
5 periods
70 % U
T
(30 % drop of U ) for
T
25 periods
< 5 % U (> 95 %
T
drop of U ) for 5 s
T
Compliance level
± 6 kV discharge on
contact
± 8 kV discharge
through air
N/A
N/A
N/A
)
Electromagnetic
environment direct­
ive
Floors should be
wood, concrete or
ceramic tile. If the
floor covering is made
of synthetic material,
the relative humidity
must be at least 30 %.
The quality of the sup­
ply voltage should be
equivalent to a typical
commercial or hospital
supply.
The quality of the sup­
ply voltage should be
equivalent to a typical
commercial or hospital
supply.
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.