Physio-Control LIFEPAK CR Plus - Manual (Page 75)

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions D-3
©2009-2010 Physio-Control, Inc.
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Electromagnetic Compatibility Guidance
Table D-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity Test
IEC 60601
Test Level
Compliance Level Electromagnetic Environment – Guidance
The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in the electromagnetic
environment specified below. The customer or the user of the defibrillator should ensure that the defibrillator is
used in such an environment.
Portable and mobile RF communications equipment
should be used no closer to any part of the
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
*
* 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.
Not Applicable Not Applicable
10 Vrms
150 kHz to 80 MHz
in ISM bands
*
Not Applicable Not Applicable
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10 V/m
80 MHz to 2.5 GHz
80 MHz to 800 MHz
for specified frequencies in the range
800 MHz to 2.5 GHz
870 MHz to 900 MHz
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).
†
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
‡
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
† 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.
‡ 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 defibrillator is used exceeds the applicable RF compliance level above, the 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
defibrillator.
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.
d 1.2 P =
d 2.3 P =
d 7.7 P =