Baylis RFP-100A - Page 41

© 2012-2019 Baylis Medical Company Inc. 41 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
(continued)
The BMC Radiofrequency Puncture Generator is intended for use in the electromagnetic
environment specified below. The customer or the user of the BMC Radiofrequency
Puncture Generator 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
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
BMC Radiofrequency Puncture
Generator including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance:
Pd ]17.1[=
80 MHz to 800 MHz
Pd ]33.2[=
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.