106
Interference
immunity tests
IEC 60601 test level
Compliance level
Electromagnetic
environment direct
ive
Conducted HF inter
ference according to
IEC 61000-4-6
3 V
eff
150 kHz to 80
MHz
Not applicable
Radiated HF interfer
ence according to
IEC 61000-4-3
3 V/m 80 MHz to
2.5 GHz
12 V/m 80 MHz to
1 GHz
3 V/m 1 GHz to
2.5 GHz
Portable and mobile
wireless equipment
should not be used at
a lesser distance from
the product 'X2 Bionic
Prosthetic System
3B5-X2' 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
a
should be less than
the compliance level.
Interference is pos
sible in the vicinity of
devices that bear the
following symbol.
Note 1:
The higher frequency range applies at 80 MHz and 800 MHz.
Note 2:
These directives may not be applicable in all cases. The propagation of electromagnetic
factors is influenced by absorption and reflection by buildings, objects and people.
a
The field strength of stationary transmitters such as base stations of radio telephones and
mobile land radio equipment, amateur radio stations, AM and FM radio and television stations
cannot be precisely determined theoretically in advance. A site survey is recommended to estab
lish the electromagnetic conditions as a result of stationary HF transmitters. If the field strength
determined at the site of the product 'X2 Bionic Prosthetic System 3B5-X2' exceeds the compli
ance level specified above, the product 'X2 Bionic Prosthetic System 3B5-X2' has to be mon
itored in regards to normal operation at each place of use. If unusual performance characterist
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