11
Manufacturer’s declaration-electromagnetic immunity
The HealthCo Royal is intended for use in the electromagnetic environment (for home healthcare and
professional healthcare) specified below.
The customer or the user of the HealthCo Royal should assure that is used in such and environment.
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
e)
10 V/m
80 MHz – 2,7 GHz
b)
80 % AM at 1 kHz c)
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 e)
10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
Portable and mobile RF
communications equipment should
be used no closer to any part of the
HealthCo Royal 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
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:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 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 HealthCo Royal is
used exceeds the applicable RF compliance level above, the HealthCo Royal should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the HealthCo Royal.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
