Otto Bock Genium 3B1 Instructions For Use Manual page 106

Table 4 – Electromagnetic interference immunity for non-life-sustaining devices and sys­
tems
Directives and manufacturer's declaration – electromagnetic interference immunity
The product 'Genium Bionic Prosthetic System 3B1 / Genium 3B1-2' is designed for operation
in an electromagnetic environment as specified below. The customer or user of the product
'Genium Bionic Prosthetic System 3B1 / Genium 3B1-2' must ensure that the device is oper­
ated in such an environment.
Interference
immunity tests
Conducted HF inter­
ference according to
IEC 61000-4-6
Radiated HF interfer­
ence according to
IEC 61000-4-3
106
IEC 60601 test level
3 V 150 kHz to 80
eff
MHz
3 V/m 80 MHz to
2.5 GHz
Compliance level
Not applicable
12 V/m 80 MHz to
1 GHz
3 V/m 1 GHz to
2.5 GHz
Electromagnetic
environment direct­
ive
Portable and mobile
wireless equipment
should not be used at
a lesser distance from
the product 'Genium
Bionic Prosthetic Sys­
tem 3B1 / Genium
3B1-2' including the
lines than the recom­
mended safety dis­
tance calculated using
the equation applic­
able for the transmis­
sion frequency.
Recommended
safety distance:
d = 0.3 √P for 80 MHz
to 800 MHz
d = 2.3 √P for
800 MHz to 2.5 GHz
where P is the nominal
output of the transmit­
ter in watts (W)
according to the trans­
mitter manufacturer
and d is the recom­
mended safety dis­
tance in metres (m).
The field strength of
stationary radio trans­
mitters at all frequen­
cies according to an
on-site investigation
should be less than
the compliance level.
Interference is pos­
sible in the vicinity of
devices that bear the
following symbol.
a