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194
Electromagnetic immunity - Equipment with life support functions
Advisable separation distances between mobile and portable RF communications
equipment and the DualMax
The DualMax is intended to be used in the electromagnetic environment specified below, The customer or user of
the defibrillator should ensure that it is used in such an environment.
Immunity test
Test level of
EN 60601-1-2:2015
(IEC 60601:2014)
Compliance level
Electromagnetic environment
Directive
Portable and mobile RF communications
equipment should not be used near any
part of the DualMax, including cables,
with a separation distance less than
the one advised, calculated using the
equation applicable to the frequency of
the transmitter.
Advisable distance of separation:
Conducted RF IEC
61000-4-6
3 Vrms 150 KHz up to 80 MHz
outside bands
a
ISM.
3 Vrms 150 KHz up to 80 MHz
outside bands
a
ISM.
d=1.2.
6 Vrms 150 KHz up to 80 MHz
outside bands
a
ISM.
6 Vrms 150 KHz up to 80 MHz
outside bands
a
ISM.
d=1.2.
Conducted RF IEC
61000-4-3
3 V/m 80 MHz up to 2.5 GHz.
10 V/m 80 MHz up to 2.5 GHz.
3 V/m 80 MHz up to 2.5 GHz.
10 V/m 80 MHz up to 2.5 GHz.
d=1.2.
80% AM to 1 KHz.
d=2.3.
80% AM to 1 KHz.
Where “P” is the maximum output power of
the transmitter in watts (W), according to
the transmitter manufacturer, and “d” is the
advisable separation distance in meters (m)
b
.
Field strengths established by RF
transmitters, as determined by an
electromagnetic site survey,
c
should be less
than the compliance level in each frequency
range
d
.
Interference can occur around
equipment marked with
the following symbol:
NOTE 1: at 80 MHz and 800 MHz, the highest frequency range is applied.
NOTE 2: these directives may not be applicable in all situations, electromagnetic transmission is affected by the absorption and
reflection of structures, objects and people.
a
- ISM bands (industrial, medical and scientific) 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 40.6 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 between 80 MHz and
2.5 GHz are intended to reduce the likelihood of mobile and portable communications equipment causing interference if inadvertently
brought into the patient areas. Therefore, an additional factor of 10/3 is used in calculating the advisable separation distance for
transmitters in these frequency ranges.
c
- Field strengths established by fixed transmitters, such as base stations for radio, telephones (cell phone/wireless) mobile land
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any accuracy. In order to
evaluate the electromagnetic environment due to fixed RF transmitters, it is advisable to consider an electromagnetic site survey, If the
measured field strength in the site where the DualMax is used exceeds the level of RF compliance used above, the DualMax should
be observed to check if operation is normal, If abnormal performance is observed, additional procedures may be required, such as
reorienting or repositioning the DualMax.
d
- Over the frequency range 150 KHz to 80 MHz, the field intensity should be less than [V1] V/m.
