EN
21
EMC Declaration
Guidance and manufacturer’s declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should ensure 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
Professional
healthcare
environment:
3 V/m
Home healthcare
environment:
10 Vm
80 MHz to
2700 MHz
Same as left
Same as left
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
using the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
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
metres (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 device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3.
