Appendix D
D-4 Respironics V60 Ventilator User Manual 1047358 Rev N
Regulatory compliance
Guidance and manufacturer's declaration - electromagnetic immunity
The V60 Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the V60
Ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601
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
10 Vrms
150 kHz to 80 MHz
in ISM bands
a
10 V/m
80 MHz to 2.5 GHz
3 Vrms
10 Vrms
10 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the V60 Ventilator, including cables, 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
Interference may occur in the vicinity of equipment marked with the
following symbol:
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 2.5 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 V60 Ventilator is used exceeds the applicable RF compliance level above, the V60 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 Ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d
3.5
V
1
-------
P=
where V
1
= 3 Vrms
d
12
V
2
-------
P=
where V
2
= 10 Vrms
d
12
E
1
-------
P=
80 MHz to 800 MHz, where E
1
= 10 V/m
d
23
E
1
-------
P=
800 MHz to 2.5 GHz, where E
1
= 10 V/m
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