Invacare Alegio Series, Руководство пользователя

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EN
18 . Electro Magnetic Compliance (EMC)
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 environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Medical Bed uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Medical Bed is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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
should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air ± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output
lines
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth ± 1 kV differential
mode
± 2 kV common mode Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s <5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Medical bed Alegio requires
continued operation during power
mains interruptions, it is recommended
that the Medical Bed Alegio be
powered from an uninterruptible
power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 0,3 A/m
The power frequency magnetic field
should be at a characteristic level of a
typical commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
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
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
outside ISM bands
a
10 Vrms
150 kHz to 80 MHz
in ISM bands
a
10 V/m
80 MHz to 2,5 GHz
1 Vrms
1 Vrms
10 V/m
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, c
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:
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
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
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.
c 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 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.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
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EN.indd 25 18/07/11 18:27