Axonics 1601 Bedienungsanleitung Seite 10

Table 3 – Test levels for radiated and conducted Immunity Tests
Guidance and manufacturer's declaration - electromagnetic immunity
The Trial Stimulator is intended for use in the electromagnetic environment specified below.
The customer or the user of the Trial Stimulator should assure that it is used in such an environment.
Immunity IEC/EN 60601
Test test level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to
2.7 GHz
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all 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
a
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 strengths in the location in which the Trial Stimulator are used exceeds
the applicable RF compliance level above, the Trial Stimulator should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such are re-orienting or relocating the
Trial Stimulator.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Compliance
level
3 Vrms Portable and mobile RF communications equipment should be
used no closer to any part of the Trial Stimulator, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1.2 √ P
10 V/m Where P is the maximum output rating of 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,
level in each frequency range.
d = 1.2 √ P 80 MHz to < 800 MHz
d = 2.3 √ P 800 MHz to < 2.7 GHz
Interference may occur in the vicinity of
equipment marked with the following symbol:
Electromagnetic environment - guidance
should be less than the compliance
a
b
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