CU Medical Systems Paramedic CU-ER1, Руководство оператора, Страница: 110 / 115

CU-ER1 Operator’s Manual _ver 3.00
110
Guidance and manufacturer’s declaration – electromagnetic immunity- for LIFE
SUPPORTING EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The Paramedic CU-ER1 is intended for use in the electromagnetic environment specified
below. The customer or the user of the Paramedic CU-ER1 should assure that it is used
in such an environment.
Immunity
Test
IEC 60601-1
test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
Paramedic CU-ER1 , including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
3 Vrms
150 kHz to 80
MHz outside ISM
bands a
3 Vrms
1.16 d P
=
Conducted RF
IEC 61000-4-6
10 Vrms
150 kHz to 80
MHz in ISM
bands
10 Vrms
1.2 d P
=
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,5
GHz
10 V/m
1.2 d
=
P
80 MHz to 800 MHz
2.3 d
=
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 metres (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:
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
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 Paramedic CU-ER1 is used exceeds the applicable RF
compliance level above, the Paramedic CU-ER1 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Paramedic CU-ER1.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.