Otto Bock X2 Series Instructions For Use Manual page 105

Interference
immunity test
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
Magnetic field at
mains frequency
(50/60 Hz) according
to IEC 61000-4-8
Note: U is the rated voltage before applying the test levels.
T
Table 4 – Electromagnetic interference immunity for non-life-sustaining devices and sys­
tems
Directives and manufacturer's declaration – electromagnetic interference immunity
The product 'X2 Bionic Prosthetic System 3B5-X2' is designed for operation in an electromag­
netic environment as specified below. The customer or user of the product 'X2 Bionic Prosthetic
System 3B5-X2' must ensure that the device is operated in such an environment.
IEC 60601 test level
± 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
3 A/m
Compliance level
N/A
N/A
N/A
)
3 A/m
Electromagnetic
environment direct­
ive
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 'X2 Bionic
Prosthetic System
3B5-X2' demands
continuous operation
even in case of an
interruption in the sup­
ply voltage, we recom­
mend supplying the
product 'X2 Bionic
Prosthetic System
3B5-X2' with an unin­
terruptible power sup­
ply or battery.
Magnetic fields at the
mains frequency
should be equivalent
to the typical levels for
commercial or hospital
environments.
105