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The Mistral Nebulizer is intended for use in the electromagnetic environment specified below. The customers or the user of
the Mistral Nebulizer should assure that it's used in such an environment.
Immunity Test
Level indicated by the
Conducted Immunity
EN 61000-4-6
(for non life-supporting
Radiated Immunity
3V/m 80MHz to 2.5GHz
EN 61000-4-3
(for non life-supporting
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the
absorption and by reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial
mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and
accurately foreseen. To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic
study of the site should be considered. If the field intensity measured in the place where the device will be used surpasses the
above mentioned applicable level of conformity, the normal functioning of the device should be monitored. If abnormal
performance arises, additional measures such as changing the device's direction or positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.
The Mistral Nebulizer surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated
Recommended separation distance between portable and mobile radio-communication devices and the monitor
interferences are under control. The client or operator of the Mistral device can help prevent electro-magnetic interference by
keeping a minimum distance between the portable and mobile RF communication devices (transmitters) and the Mistral
device, as recommended below, in relation to the radio-communication maximum output power.
Maximum nominal
output power of the
Transmitter W
0,01
0,1
1
10
100
For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres
(m) can be calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output
power of the transmitter in Watt (W) depending on the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the
absorption and by the reflection from buildings, objects and people.
Guidance and manufacturer's declaration – Immunity Emissions
Compliance Level
EN 60601-1-2
3Vrms 150kHz to
80Mhz
devices)
devices)
Separation distance from the frequency transmitter (m)
150 kHz to 80 MHz
d = [3.5 / V
]
P
1
0,12
0,38
1,2
3,8
12
Electromagnetic environment - guidance
V
= 3 V rms
The portable and mobile RF communication
to the Mistral device, than the separation
1
devices, including cables, must not be used closer
distance calculated by the equation applicable to
the transmitter frequency. Recommended
E
= 3 V / m
1
separation distance
d = [3.5 / V
d = [12 / E
d = [23 / E
Where P is the maximum nominal output voltage
of the transmitter in Watt (W) depending on the
manufacturer of the transmitter and the
recommended separation distance in metres (m).
The intensity of the field from the fixed RF
transmitters, as determined by an electro-
magnetic study of the site
the level of conformity of each frequency interval
. It is possible to check for interference in
b)
proximity to devices identified by the following
symbol:
80 MHz to 800 MHz
d = [12/E
]
P
1
0,12
0,38
1,2
3,8
12
19
]
P
1
]
from 80 MHz to 800MHz
P
1
]
from 800 MHz to 2.5 GHz
P
1
, could be lower than
a)
800 MHz to 2.5 GHz
d = [23/E
]
P
1
0,23
0,73
2,3
7,3
23
GB
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