100
50
0
0.10
1.00
Particle Diameter ( m)
Guidance and manufacturer's declaration-electromagnetic emissions
The Breathy is intended for use in the electromagnetic environment specified below.
The customer or the user of the Breathy should assure that it is used in such an environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions
Compliance
IEC 61000-3-3
Guidance and manufacturer's declaration-electromagnetic immunity
The Breathy is intended for use in the electromagnetic environment specified below.
The customer or the user of the Breathy should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic
± 6 kV contact
± 6 kV contact
discharge (ESD) IEC
± 8 kV air
± 8 kV air
61000-4-2
Electrical fast
± 2kV for power supply
+ 2kV for power supply
transient/burst IEC
lines
lines
61000-4-4
± 1kV for input/output lines
Not applicable
Surge IEC 61000-4-5 ± 1kV line(s) to line(s)
+ 1kV differential mode
± 2kV line(s) to earth
Not applicable
Voltage Dips, short
<5% UT(>95% dip in UT)
<5% UT(>95% dip in
interruptions and
for 0,5 cycle
UT) for 0,5 cycle
voltage variations on
40% UT(60% dip in UT) for
40% UT(60% dip in UT)
power supply input
5 cycles
for 5 cycles
lines IEC 61000-4-11
70% UT(30% dip in UT) for
70% UT(30% dip in UT)
25 cycles
for 25 cycles
<5% UT(>95% dip in UT)
<5% UT(>95% dip in
for 5 s
UT) for 5 s
10.00
Electromagnetic environment-guidance
The Breathy 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.
The Breathy 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.
Compliance level
Electromagnetic environment-guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%
Mains power quality should be that of a typical com-
mercial or hospital environment.
Mains power quality should be that of a typical com-
mercial or hospital environment.
Mains power quality should be that of a typical com-
mercial or hospital environment. If the user of the
Breathy requires continued operation during power
mains interruptions, it is recommended that the Breathy
be powered from an uninterruptible power supply or a
battery.
10.00
Power frequency
3 A/m
(50/60 Hz) magnetic
field IEC 61000-4-8
7.50
The Breathy is intended for use in the electromagnetic environment specified below.
The customer or the user of the Breathy should assure that is used in such and environment.
5.00
Immunity test IEC 60601 test level Compliance level
2.50
Conducted RF
3 Vrms
IEC 61000-4-6
150 KHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80MHz to 2,5 GHz
0.00
50.00
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 Breathy is used exceeds the applicable RF compliance level above, the Breathy should be observed
to verify normal operation. If abnormal performance is observed, additional measures my be necessary, such as re-orienting or
relocating the Breathy.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distance between portable and mobile RF communications equipment and the Breathy
The Breathy is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the Breathy can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Breathy as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter (W)
0,01
0,1
1
10
100
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 transmit-
ter in watts (W) according to the transmitter manufacturer.
NOTE1: At 80 MHz and 800 MHz, the separation distance for 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.
3 A/m
The Breathy power frequency magnetic fields should
be at levels characteristic of a typical location in a typi-
cal 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
Electromagnetic environment-guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the Breathy including cables, than the recommended
separation distance calculated from the equation applicable to the frequen-
cy of the transmitter. Recommended separation distance:
d = 1,2 √P
Not applicable
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,5 GHz
Where P is the maximum output power rating of the transmitter in watts
3 V/m
(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 electro-
magnetic 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:
Separation distance according to frequency of transmitter (m)
150kHz to 80MHz / d=1,2√P
80MHz to 800MHz / d=1,2√P
0,12
0,12
0,38
0,38
1,2
1,2
3,8
3,8
12
12
800MHz to 2,5GHz / d=2,3√P
0,23
0,73
2,3
7,3
23
21