Mindray BeneHeart D2, Operator'S Manual

Page: 179 / 208

Defibrillator/Monitor Operator’s Manual C - 3
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
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:
150k to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.7 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
:
6 Vrms
in ISM bands and amateur radio
bands
a
between 0.15 MHz and 80
MHz
6 Vrms (V2)
Radiated RF EM
fields IEC 61000-4-3 3V/m
80 MHz to 2.7 GHz
(IEC60601-2-27, IEC60601-2-25,
IEC60601-2-49)
3 V/m (E1)
10V/m
80 MHz to 2.7 GHz
(IEC60601-2-4)
10 V/m
20V/m
80 MHz to 2.7GHz
(IEC60601-2-4
,
IEC80601-2-30,
ISO 80601-2-55,, ISO 80601-2-61)
20 V/m
Proximity fields
from RF wireless
communications
equipment
IEC61000-4-3
27 V/m
380 to 390 MHz
27 V/m
28 V/m
430 to 470 MHz,
800 to 960 MHz,
1700 to 1990 MHz,
2400 to 2570 MHz
28 V/m
9 V/m
704 to 787 MHz,
5100 to 5800 MHz
9 V/m
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. The amateur radio bands between 0,15 MHz and
80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz
to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz
to 54,0 MHz.
b
Compliance level in the ISM frequency bands between 150 kHz to 80 MHz and in the frequency range 80 MHz to 2.7 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, field strengths should be less than 3V/m.
P
V
d




=
1
5 . 3
P
E
d




=
1
7
P
E
d




=
1
5 . 3