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Guidance and manufacturer's declaration—electromagnetic immunity
The ECHELON FLEX Powered Vascular Stapler is intended for use in the electromagnetic environment specified below. The customer or the
user of the ECHELON FLEX Powered Vascular Stapler should ensure that it is used in such an environment.
IMMUNITY
IEC 60601 TEST
test
LEVEL
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
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 ECHELON FLEX Powered Vascular Stapler is used exceeds the applicable RF compliance level above, the ECHELON FLEX
Powered Vascular Stapler, should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the ECHELON FLEX Powered Vascular Stapler.
Compliance
level
Portable and mobile RF communications equipment should be used no
closer to any part of the ECHELON FLEX™ Powered Vascular Stapler,
including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Not applicable
Not Applicable
3 V/m
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 meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
8
Electromagnetic environment –
guidance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
should be less than the compliance level in
a
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