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Guidance and manufacturer's declaration – electromagnetic immunity
The MiniElite aerosol therapy equipment with battery is intended for use in the electromagnetic environment
specified below. The customer or the user of the MiniElite aerosol therapy equipment with battery should
assure that is used in such an environment.
Immunity Test
Test Level
Electrostatic discharge
± 6kV contact
(ESD)
IEC 61000-4-2
± 8kV air
Electrical fast
± 2kV for power supply
transient/burst
lines
IEC 61000-4-4
±1kV for input/output
lines
Surge
±1kV differential mode
IEC 61000-4-5
±2kV common mode
Voltage dips, short
<5% U
(>95% dip
T
interruptions and voltage
in U
) for 0,5 cycle
T
variation on power
40% U
(60% dip
supply input lines
T
in U
) for 5 cycle
T
IEC 61000-4-11
70% U
(30% dip
T
in U
) for 25 cycle
T
<5% U
(>95% dip
T
in U
) for 5 sec
T
Power frequency
3 A/m
50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
MiniElite Compressor with Battery
Compliance level
Electromagnetic
environment – guidance
± 6kV contact
Floors should be wood,
concrete or ceramic tile.
If floors are covered
± 8kV air
with synthetic material,
the relative humidity
should be at least 30%.
Not applicable
Mains power quality
should be that of a
typical commercial or
hospital environment
Not applicable
Mains power quality
should be that of a
typical commercial or
hospital environment
Not applicable
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the MiniElite
aerosol therapy
equipment requires
continued operation
during power mains
interruptions, it is
recommended that the
MiniElite aerosol
therapy equipment be
powered from an
uninterruptible power
supply or a battery
Not applicable
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Guidance and manufacturer's declaration – electromagnetic immunity
The MiniElite aerosol therapy equipment with battery is intended for use in the electromagnetic environment
specified below. The customer or the user of the MiniElite aerosol therapy equipment with battery should
assure that it is used in such an environment.
Immunity Test
IEC 60601 test level
Conducted RF
3Vrms
IEC 61000-4-6
150kHz to 80MHz
Radiated RF
3V/m
IEC 61000-4-3
80MHz to 2.5GHz
NOTE 1: At 80MHz and 800MHz, 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 strength from fixed transmitter, 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 MiniElite aerosol therapy equipment is used exceeds the applicable RF
compliance level above, the MiniElite aerosol therapy equipment should observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the MiniElite aerosol therapy equipment.
b. Over the frequency range 150kHz to 80MHz, field strength should be less than 3V/m
Page 3 of 8
Compliance level
Electromagnetic
environment – guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the
MiniElite aerosol therapy equipment,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Not applicable
d = 4
P 80MHz to 800MHz
3V/m
d = 2.33
P 800MHz to 2.5GHz
where P is the maximum output
80MHz to 2.5GHz
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m). Field strengths from fixed
RF transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
each frequency range.
may occur in the vicinity of
equipment marked with the following
symbol:
a
should
b
Interference
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