ZOLL X Series Monitor Defibrillator Rev H - Manual (Page 317)

Electromagnetic Compatibility Guidance and Manufacturer’s Declaration
9650-001355-01 Rev. H X Series Operator’s Guide A-31
Electromagnetic Immunity: Life-Supporting Functions
Life-supporting functions of the X Series include: ECG waveform monitoring from leads or
pads, the pacing pulse output, QRS detection, defibrillation energy discharge, and shock
advisory functions.
Guidance and manufacturer’s declaration – electromagnetic immunity – for life-
supporting equipment and systems
The life-supporting functions of the X Series are intended for use in the electromagnetic environment specified
below. The customer or user of the X Series should ensure 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 X Series,
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 a
3 Vrms
d = 1.2
10 Vrms
150 kHz to 80 MHz
in ISM bands a
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 according to the transmitter
manufacturer and d is the recommended separation
distance in meters. b
Field strengths from fixed RF transmitters, as
determined by 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 X Series is used exceeds the applicable RF
compliance level above, the X Series should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the X Series.
d. Over the frequency ranges 150 kHz to 80 MHz field strength should be less than 10 V/m.
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