Physio Control LIFEPAK 20, Manual

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Appendix I
Electromagnetic Compatibility Guidance
LIFEPAK 20e Defibrillator/Monitor Operating Instructions I-3
©2006-2015 Physio-Control, Inc.
Table 3
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The LIFEPAK 20e defibrillator/monitor is intended for use in the electromagnetic environment specified below.
The customer or the user of the LIFEPAK 20e defibrillator/monitor should ensure that the defibrillator/monitor is
used in such an electromagnetic 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 20e defibrillator/monitor, 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
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.
3 Vrms d = 1.2

P
10 Vrms
150 kHz to 80 MHz
in ISM bands
1
10 Vrms d = 1.2

P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m d = 1.2

P 80 MHz to 800 MHz
d = 2.3

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). 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:
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 transmitter, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the LIFEPAK 20e defibrillator/monitor is used exceeds the applicable RF compliance level above, the LIFEPAK 20e
defibrillator/monitor 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 20e defibrillator/monitor.
4. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/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.