1000DF00480 Issue 2 47/48
Compliance (continued)
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
LIFE SUPPORT Equipment
The pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the pump should ensure that it is used in such an environment.
Immunity Test
IEC/EN 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
IEC/EN 61000-4-6
Conducted RF
IEC/EN 61000-4-3
Radiated RF
3 V rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
10 V rms
(Note 3)
10 V/m
(Note 3)
Portable and mobile RF communications equipment should be used no
closer to any part of the pump, including cables, than the recommended
separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended Separation Distance
12
d = [-----] √P 80 MHz to 800 MHz
V2
12
d = [-----] √P 80 MHz to 800 MHz
E1
12
d = [-----] √P 800 MHz to 2.5 GHz
E1
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).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:
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 IEC/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 pump is used exceeds the applicable RF compliance level above, the pump should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the pump.
c Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
