6-14
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The
TriaDyne Proventa
Critical Care Therapy System is intended for use in an electromagnetic environment specified
below. The customer or user of the
TriaDyne Proventa
Critical Care Therapy System 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
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the
TriaDyne
Proventa
Critical Care Therapy System, including
cables, than the recommended separation distance
calculated from the equation application to the
frequency of the transmitter.
Recommended separation distance
d = [ 1.2 }
d = [ 1.2 ] 80 MHz to 800 MHz
d = [ 2.3 ] 800 MHz to 2.5 GHz
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.
1
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 asses 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 [ME EQUIPMENT OR ME SYSTEM] is used
exceeds the applicable RF compliance level above, the [ME EQUIPMENT OR ME SYSTEM] should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the [ME EQUIPMENT OR ME SYSTEM].
2
Over the frequency range 150 kHz, field strengths should be less than [V1] V / m.
Recommended Separation Distances between Portable and Mobile RF Communications
Equipment and the TriaDyne Proventa Critical Care Therapy System
The
TriaDyne Proventa
Critical Care Therapy System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
TriaDyne Proventa
Critical Care Therapy
System can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the
TriaDyne Proventa
Critical Care Therapy System as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80
MHz
not applicable
80 MHz to 800
MHz
d = [ 1 .2 ]
800 MHz to 2 .5 GHz
d = [ 2 .3 ]
0.01
not applicable
0.12
0.23
0.1
not applicable
0.37
0.74
1
not applicable
1.17
2.33
10
not applicable
3.69
7.38
100
not applicable
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separate distance d in meters
(m) can be estimated 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; These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from surfaces, objects and people.
