Ossur PROPRIO FOOT, Technical Manual

Page: 19 / 24

19 18
guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should
assure that it is used in such an environment.
immunity Test iec 60601 Test level compliance level electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the recommended separatvion
distance calculated from the equation applicable to
the frequency of the transmitter. Recommended
separation distance:
Conducted RF IEC
61000-4-6
3 Vrms, 150 kHz to
80 MHz
3 Vrms d=1.2√P
Radiated RF IEC
61000-4-3
3 V/m, 80 MHz to
2.5 GHz
3 V/m d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
where “P” is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (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:
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
* 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 device is used exceeds the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the device.
** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.