EN-19
Manufacturer’s declaration-electromagnetic immunity
FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of FORA IR20/IR21 should assure that it is used in the environment specified below.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment-guidance
(for home healthcare and professional healthcare environment)
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms:
0,15 MHz – 80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Not applicable
Not applicable
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Portable and mobile RF communications equipment must not be used close to any parts of
FORA
IR20/IR21 including cables, other than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,7 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 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 to 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 FORA IR20/IR21 is used exceeds the applicable RF
compliance level above, FORA IR20/IR21 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating FORA IR20/IR21.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
