Otto Bock Genium 3B1 Instructions For Use Manual page 105

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
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
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
3 A/m
Compliance level
± 6 kV discharge on
contact
± 8 kV discharge
through air
N/A
N/A
N/A
)
3 A/m
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
Bionic Prosthetic Sys­
tem 3B1 / Genium
3B1-2' demands con­
tinuous operation even
in case of an interrup­
tion in the supply
voltage, we recom­
mend supplying the
product 'Genium
Bionic Prosthetic Sys­
tem 3B1 / Genium
3B1-2' with an uninter­
ruptible power supply
or battery.
Magnetic fields at the
mains frequency
should be equivalent
to the typical levels for
commercial or hospital
environments.
105