User's Manual Part 3

10-32
Table 203Guidance and manufacturer’s declarationelectromagnetic immunityfor LIFE-SUPPORTING EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declarationelectromagnetic immunity
The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System
should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the 3880 System, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
3 Vrms
150 kHz to 80 MHz
3 V d = 1.17 ¥ P
outside ISM bands
a
IEC 61000-4-6
10 Vrms
150 kHz to 80 MHz
10 V
d = 1.20 ¥ P
outside ISM bands
a
Radiated RF
10 Vrms
80 MHz to 2.5 GHz
10 V/m
d = 1.20 ¥ P
80 MHz to 800 MHz
IEC 61000-4-3
d = 2.33 ¥ P
800 MHz to 2.5 GHz
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:
IEC 60417, No. 417-IEC5140, "Source of Non-Ionizing Radiation"
Symbol
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2These 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 is 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 3880 System is used
exceeds the applicable RF compliance level above, the 3880 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 3880 System.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V 1] V/m