13
Guide and Manufacturer's Declaration
The 190 ventilator is intended for use in the electromagnetic environment specified below. The customer and / or end user of the 190 ventilator must
ensure that the equipment is used in such environment.
IMMUNITY TEST
Level of conformity
Guide to the electromagnetic environment
Conducted RF
IEC 61000-4-6
Radiated immunity CEI
EN 61000-4-3
6 V
150kHz to 80MHz in ISM bands and amateur radio bands
80% AM a 1khz
10 V/m
80MHz to 2.7 Ghz
The equipment for communication in portable and mobile radio-
frequency (RF) should not be placed near any part of the
appliance, including cables etc. and should be kept at a distance
never less than the recommended and calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 0,583x
√P
d = 1,2 x
√P
from 80Mhz to 800MHz
d = 2,3 x
√P
from 800Mhz to 2,7 GHz
where P is the maximum rated power output 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 should be at less than the compliance
level in each frequency range b. Interference may
occur in the vicinity of equipment marked with
the following symbol:
NOTE 1 At 80 MHz and 800 MHz the separation distance for the range of higher frequency is applied
NOTA 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 lung ventilator 190 is used exceeds the applicable RF compliance level above, the lung ventilator 190 should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the lung ventilator 190.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.
Recommended separation distances between portable and mobile communications equipment and the ventilator 190.
The 190 ventilator is intended for use in an electromagnetic environment in which radiated RF disturbance is controlled. The customer or the user of the 190
ventilator may prevent electromagnetic interference by maintaining a minimum distance between the communications equipment radio frequency (RF)
Portable and mobile equipment (transmitters) and the 190 ventilator, as described below and in accordance with the maximum output power of the
communication device
Maximum output power rating
of the transmitter
Separation distances according to frequency of transmitter (m)
(W)
From 150 kHz to 80 Mhz
Inside and outside ISM bands
d = 0,583x
√P
From 80 Mhz to 800 Mhz
d = 1,2x
√𝑃
From 800 Mhz to 2,7 Ghz
d = 2,3x
√𝑃
0,01
0.058
0,12
0.23
0,1
0.184
0,38
0.73
1
0.583
1,2
2.3
10
1.844
3,8
7,3
100
5.83
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in metres (m) can be determined 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 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.
NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in the
ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.