Mindray BeneHeart D1, Operator'S Manual

Page: 84 / 106

B-2
Guidance and Declaration - Electromagnetic Immunity
The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the
equipment should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level Compliance level Electromagnetic environment - guidance
Conduced RF
IEC 61000-4-6
3 Vrms
150k to 80 MHz
Outside ISM
bandsa
3 Vrms (V1) Portable and mobile RF communications equipment should be
used no closer to any part of the device, including cables, than
the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance:
P
V
d





1
3.5
P
V
d





2
12
P
E
d





1
12
80 MHz to 800 MHz
P
E
d





1
23
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, 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: .
10 Vrms
150kHz to 80MHz
in ISM bandsa
(for life support
devices)
10 Vrms (V2)
Radiated RF
IEC 61000-4-3
10V/m
80 MHz to 2.5 GHz
(for life support
devices)
10 V/m (E1)
20V/m
80 MHz to 2.5 GHz
(ISO 9919)
20 V/m (E2)
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.
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 Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency range 80 MHz to 2.5 GHz are
intended to decrease the likelihood that portable/ mobile communication 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 device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
d Over the frequency ranges 150 kHz to 80 MHz beyond ISM band, field strengths should be less than 3V/m; within ISM band,
field strengths should be less than 10V/m.