Otto Bock X2 Series Instructions For Use Manual page 106

Interference
immunity tests
Conducted HF inter­
ference according to
IEC 61000-4-6
Radiated HF interfer­
ence according to
IEC 61000-4-3
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
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 '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
should be less than
the compliance level.
Interference is pos­
sible in the vicinity of
devices that bear the
following symbol.
a