Otto Bock Genium X3 Instructions For Use Manual page 60

Appendices
Interference immunity
test
Voltage drops, short inter­
ruptions and fluctuations of
the supply voltage accord­
ing to IEC 61000-4-11
Magnetic field at mains fre­
quency (50/60 Hz) accord­
ing 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 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 Pros­
thetic System 3B5-X3 / Genium X3 3B5-2' must ensure that the device is operated in such an environment.
60
IEC 60601 test level
< 5 % U
T
(> 95 % drop of U ) for
T
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 % drop of
T
U ) for 5 s
T
3 A/m
Compliance level
N/A
3 A/m
Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge­
Electromagnetic environ­
ment directive
The quality of the supply
voltage should be equival­
ent to a typical commercial
or hospital supply. If the
user of the product 'Geni­
um X3 - Bionic Prosthetic
System 3B5-X3 / Genium
X3 3B5-2' demands con­
tinuous operation even in
case of an interruption in
the supply voltage, we
recommend supplying the
product 'Genium X3
Bionic Prosthetic System
3B5-X3 / Genium
3B5-2' with an uninterrupt­
ible power supply or bat­
tery.
Magnetic fields at
mains frequency should be
equivalent to the typical
levels for commercial or
hospital environments.
nium X3 3B5-2/3B5-2=ST
-
X3
the