12
Guide and Manufacturer's Declaration
The 170 ventilator is intended for use in the electromagnetic environment specified below. The customer and / or user of the ventilator 170 must ensure
that the device is used in such environment.
IMMUNITY TEST
Conformity level
Guida all’ambiente elettromagnetico
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8kV at contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV in aria
Floors should be wood, concrete or ceramic tile. If the
floors are covered with synthetic material, the relative
humidity should not exceed most 30%.
Electrical fast transient/burst
IEC 61000-4-4
± 2kV power supply
± 1kV or input/ouput lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Over voltage
IEC 61000-4-5
± 0.5 , 1kV for line to line surge
0.5, 1, 2kV for line to ground surge
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips
IEC 61000-4-11
0 % UT; 0,5 cycles at 0°,
0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0% UT 1 cycles and 70% UT 25/30 cycles (25 at
50Hz and 30 at 60Hz)
Single phase at 0°
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
lung ventilator 170 requires
continued operation during power
mains interruptions, it is recommended
that the lung ventilator 170
be powered from an uninterruptible
power supply or a battery.
Voltage interruptions
IEC 61000-4-11
0% UT; 250/300 cycle
Power frequency (50-60 Hz) magnetic
field
IEC 61000-4-8
30 A/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 value of the tension of power source
Guide and Manufacturer's Declaration
The 170 ventilator is intended for use in the electromagnetic environment specified below. The customer and / or end user of the 170 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
da 80Mhz a 800MHz
d = 2,3 x
√P
da 800Mhz a 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
NOTe 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 170 is used exceeds the
applicable RF compliance level above, the lung ventilator 170 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 170.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 6 V/m.