Physio Control LIFEPAK 15, Руководство по эксплуатации

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Appendix E | Electromagnetic Compatibility Guidance
©2007-2015 Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillator Operating Instructions
265
Table 49 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 15 monitor/defibrillator is intended for use in the electromagnetic environment
specified below. The customer or the user of the LIFEPAK 15 monitor/defibrillator 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 LIFEPAK 15 monitor/defibrillator,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz
outside ISM
bands
1
3 Vrms
d = 1.2
10 Vrms
150 kHz to 80 MHz
in ISM bands 1
10 Vrms
d = 1.2
Radiated RF
IEC 61000-4-3 10 V/m
80 MHz to 2.5 GHz 10 V/m
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 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). 2
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
3
should be less than the compliance level in
each frequency range.
4
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
1 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.
2 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.
3 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 LIFEPAK 15 monitor/defibrillator is used exceeds
the applicable RF compliance level above, the LIFEPAK 15 monitor/defibrillator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the LIFEPAK 15 monitor/defibrillator.
4 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.