AtriCure ASU2-115, Руководство пользователя

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P000463.F
Page 9 of 39
1.4.4.
EMC Guidance and Manufacturer’s Declaration
Guidance and manufacturer’s declaration – electromagnetic immunity
The AtriCure Ablation and Sensing Unit (ASU) is intended for use in the electromagnetic environment specified
below. The customer or the user of the ASU should assure that it is used in such an environment.
IMMUNITY
test IEC 60601 TEST
LEVEL Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications equipment
should be used no closer to any part of the ASU,
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
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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should
be less than the compliance level in each frequency
range.
b
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 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 ASU is used exceeds the
applicable RF compliance level above, the ASU should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the ASU.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.