Otto Bock Genium X3 Series Instructions For Use Manual page 107

Bionic prosthetic system
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Interference
immunity test
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 '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.
IEC 60601 test level
3 A/m
Compliance level
3 A/m
Electromagnetic
environment direct­
ive
Magnetic fields at the
mains frequency
should be equivalent
to the typical levels for
commercial or hospital
environments.
107

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