Ossur i - DIGITS Gebrauchsanweisung Seite 12

Guidance and manufacturer's declaration – electromagnetic immunity
Össur Myoelectric Prosthetic Devices are intended for use in the electromagnetic environment specified below.
The customers or the users of Össur Myoelectric Prosthetic Devices should assure that each are used in such an
environment.
Immunity test IEC 60601 test level Compliance level
Conducted RF Not applicable
IEC 61000-4-6
Radiated RF IEC 12 V/m
61000-4-3 26 MHz to
1000 MHz
10 V/m
1000 MHz to
2700 MHz
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Össur Myoelectric
Prosthetic Devices are used exceeds the applicable RF compliance level above, Össur Myoelectric Prosthetic
Devices should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re- orienting or relocating the Össur
Myoelectric Prosthetic Devices
Electromagnetic environment – guidance
Not applicable Portable and mobile RF communications
Battery Powered equipment should be used no closer to any part of
No Cables the Össur Myoelectric Prosthetic Devices including
>3m cables, than the recommended separation distance
calculated from the equation appropriate to the
12 V/m
frequency of the transmitter.
26 MHz to
1000 MHz
Recommended separation distance
d = 1.2 √P
10 V/m
d = 1.2 √P 80 MHz to 800 MHz
1000 MHz to
d = 2.3 √P 800 MHz to 2.7 GHz
2700 MHz
Where P is the maximum output power rating of
1kHz 80% AM
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of equipment
marked with the following symbol:
b
a
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