Invacare Alegio Series User Manual page 23

Guidance and manufacturer's declaration – electromagnetic immunity
The Medical bed is intended for use in the electromagnetic environment specified below. The user of
the Medical Bed should assure that it is used in such an electromagnetic environment.
IMMUNITY IEC 60601 TEST
test LEVEL
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
outside ISM bands
10 Vrms
150 kHz to 80 MHz
in ISM bands
Radiated RF 10 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz
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.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
a
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 has been incorporated into the formulae used in calculating the recommended separation distance for
transmitters in these frequency ranges.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
c
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 Medical Bed is used
exceeds the applicable RF compliance level above, the Medcial Bed should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the Mecdical Bed.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
d
Compliance
level
1 Vrms
a
1 Vrms
a
10 V/m
25
Electromagnetic environment – guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Medical
Bed, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 3,5 P
d = 12 P
d = 1,2 P 80 MHz to 800 MHz
d = 2,3 P 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 metres (m).
b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
d
Interference may occur in the vicinity
of equipment marked with
the following symbol:
c