B.O.L.T User Manual
49
© Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
Table 4
– Guidance and manufacturer’s declaration – electromagnetic immunity – for
all medical electrical equipment and medical electrical systems that are not life-
supporting
Guidance and manufacturer’s declaration – electromagnetic immunity
The B.O.L.T device is intended for use in the electromagnetic environment specified below. The customer or
the user of the B.O.L.T device should assure that it is used in such an environment.
Immunity test
60601 test level
Compliance
level
Electromagnetic environment
–
guidance
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 V in ISM and
amateur
radio
bands
between
0.15 MHz and 80
MHz
80% AM at 1 kHz
10 V/m
80 MHz to 2,7 GHz
80 % AM at 1kHz
Proximity
fields
from RF wireless
communications
equipment (As per
table 9)
3 Vrms
150 kHz to 80
MHz
6 V in ISM and
amateur radio
bands between
0.15 MHz and
80 MHz
80% AM at 1
kHz
10 V/m
80 MHz to 2,7
GHz
80 % AM at
1kHz
3 V/m
2.7 GHz to 6
GHz
80 % AM at
1kHz
Proximity fields
from RF wireless
communications
equipment (As
per table 9)
Portable and mobile RF communications
equipment should be used no closer to
any part of B.O.L.T device, 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 150kHz to 80 MHz
d = 0.6√P 80 MHz to 2,7 GHz
d = 2,3√P 80 MHz to 6 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 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 all situations. Electromagnetic propagation is affected by absorption