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Guidance and Manufacturer's Declaration—Electromagnetic Immunity - LIFE SUPPORT Equipment
The Workstation is intended for use in the electromagnetic environment specified below .
The customer or the user of the Workstation should ensure that it is used in such an environment .
EN 60601-1-2
Immunity Test
Test Level
EN 61000-4-6
3 V rms
Conducted RF
150 kHz to 80 MHz
EN 61000-4-3
3 V/m
Radiated RF
80 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 .
Note 3—Compliance levels raised by EN 60601-2-24 .
a) 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 is used in calculating the recommended
separation distance for transmitters in these frequency ranges .
b) 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 Workstation is used exceeds the applicable RF compliance level above, the
Workstation should be observed to verify normal operation . If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Workstation .
c) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m .
Compliance
Electromagnetic Environment – Guidance
Level
Portable and mobile RF communications equipment should be used
no closer to any part of the Workstation, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter .
Recommended Separation Distance
d = [-----] √P
d = [-----] √P 80 MHz to 800 MHz
10 V rms
(Note 3)
d = [-----] √P 80 MHz to 2 .5 GHz
d = [-----] √P 800 MHz to 2 .5 GHz
10 V/m
(Note 3)
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 metres (m) .a
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, b should be less than the compliance level
in each frequency range . c
Interference may occur in the vicinity of equipment marked with the
following symbol:
1000SM00015 Issue 8
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Alaris® Gateway Workstation
Appendix
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