Cardinal Health Alaris GW Technical & Service Manual page 58

Electromagnetic Compatibility (continued)
Guidance and Manufacturer's Declaration—Electromagnetic Immunity
The Alaris® GW Volumetric Pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the Alaris® GW Volumetric Pump should ensure that it is used in such an environment.
EN 60601-1-
Immunity Test
Test Level
EN 61000-4-6 3 V rms
Conducted RF 150 kHz to 80
EN 61000-4-3
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.
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
a
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and
b
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.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
c
Alaris® GW Volumetric Pump
LIFE SUPPORT Equipment
Compliance
Level
10 V rms
(Note 3)
MHz
3 V/m 10 V/m
(Note 3)
Specifications
Electromagnetic Environment – Guidance
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
3.5
d = [-----] √P
V 1
12
d = [-----] √P 80 MHz to 800 MHz
V
2
12
d = [-----] √P 80 MHz to 2.5 GHz
E 1
23
d = [-----] √P 800 MHz to 2.5 GHz
E 1
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).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
c
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
8/77
a
b
should be less than the compliance level in
1000SM00006 Issue 4