Otto Bock 3B1-2/3B1-2-ST, Instructions For Use Manual

Page: 113 / 116

Interference immunity
tests IEC 60601 test level Compliance level Electromagnetic environ­
ment directive
Conducted HF interfer­
ence
according to
IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz Not applicable
Radiated HF interference
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 wire­
less equipment should not
be used at a lesser dis­
tance from the product
'Genium Bionic Prosthetic
System 3B1 / Genium
3B1-2' including the lines
than the recommended
safety distance calculated
using the equation applic­
able for the transmission
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 out­
put of the transmitter in
watts (W) according to the
transmitter
manufacturer
and d is the recommended
safety distance in metres
(m).
The field strength of sta­
tionary radio transmitters at
all frequencies according
to an on-site investigation
a
should be less than the
compliance level.
Interference is possible 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 influ­
enced 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 the­
oretically in advance. A site survey is recommended to establish the electromagnetic conditions as a result of sta­
tionary HF transmitters. If the field strength determined at the site of the product 'Genium Bionic Prosthetic Sys­
tem 3B1 / Genium 3B1-2' exceeds the compliance level specified above, the product 'Genium Bionic Prosthetic
System 3B1 / Genium 3B1-2' has to be monitored in regards to normal operation at each place of use. If unusual
performance characteristics are noted, taking additional steps may be necessary, for example changing the ori­
entation or moving the product 'Genium Bionic Prosthetic System 3B1 / Genium 3B1-2'
113
Appendices