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Guidance and manufacturer’s declaration
electromagnetic immunity
The NEBULIZER MODEL NE1005 is intended for use in the electromagnetic environment
specified below. The customer or the user of the NEBULIZER MODEL NE1005 should assure
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
3 Vrms
150 kHz to 80 MHz
3 Vrms Portable and mobile RF communications
equipment should be used no closer to any
part of the NEBULIZER MODEL NE1005,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
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. Interference may occur in
the vicinity of equipment marked with the
following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
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 NEBULIZER MODEL NE1005 is used exceeds the applicable RF compliance level above, the
NEBULIZER MODEL NE1005 should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the NEBULIZER
MODEL NE1005.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration
electromagnetic emissions
The NEBULIZER MODEL NE1005 is intended for use in the electromagnetic environment
specified below. The customer or the user of the NEBULIZER MODEL NE1005 should assure
that it is used in such an environment.
Emissions Compliance Electromagnetic environment-
guidance
RF emissions
CISPR 11
Group 1 The NEBULIZER MODEL NE1005
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 NEBULIZER MODEL
NE1005 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 NEBULIZER MODEL NE1005 is intended for use in the electromagnetic environment
specified below. The customer or the user of the NEBULIZER MODEL NE1005 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 and dc lines
±2 kV for power
supply lines and dc lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) and neutral ±1 kV line(s) and neutral 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 5s
<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 5s
Mains power quality
should be that of a
typical commercial or
hospital environment. If
a dips or an interruption
of mains power occurs,
the current of the
NEBULIZER MODEL
NE1005 may be dropped
off from normal level, it
may be necessary to use
uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3A/m Power frequency
magnetic fields
should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level
Recommended separation distances between
portable and mobile RF communications equipment and the NEBULIZER
MODEL NE1005
The NEBULIZER MODEL NE1005 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the NEBULIZER MODEL
NE1005 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the NEBULIZER
MODELI NE1005 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power
of transmitter
Separation distance according to frequency of transmitter
m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.
24

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