Philips Respironics V60, User Manual

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D-4
Regulatory compliance
Guidance and manufacturer's declaration - electromagnetic immunity
The V60/V60 Plus Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of
the V60/V60 Plus Ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2
test level
Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
outside ISM bands
a
6 Vrms
150 kHz to 80 MHz
in ISM bands
a
3 V/m
e
80 MHz to 2.7 GHz
380 MHz to 390 MHz
430 MHz to 470 MHz
704 MHz to 787 MHz
800 MHz to 960 MHz
1.700 GHz to 1.990 GHz
2.400 GHz to 2.570 GHz
5.100 GHz to 5.800 GHz
3 Vrms
6 Vrms
3 V/m
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the V60/V60 Plus Ventilator, including ca-
bles, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance:
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
b
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
c
should be less than the compliance
level in each frequency range.
d
NOTE 1: At 80 MHz and 800 MHz, 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. 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 2.7 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 V60/V60 Plus Ventilator is used exceeds the applicable RF compliance level above, the V60/V60 Plus Ventilator
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the V60/V60 Plus Ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
e. According to IEC 60601-1-2: 2014
d
3.5
V
1
-------
P =
where V
1
= 3 Vrms
d
12
V
2
-------
P =
where V
2
= 6 Vrms
d
12
E
1
-------
P =
80 MHz to 800 MHz, where E
1
= 3 V/m
d
23
E
1
-------
P =
800 MHz to 2.7 GHz, where E
1
= 3 V/m