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Care and maintenance
179
Advisable separation distances between mobile and portable RF communications equipment and the CardioMax
The CardioMax 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 ABNT NBR
IEC 60601
Compliance level
Electromagnetic environment – Directive
Portable and mobile RF communications
equipment should not be used near any part
of the CardioMax, 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
[V
1
] V
10 Vrms
150 KHz up to 80 MHz outside
bands
a
ISM
[V
2
]V
10 V/m
80 MHz up to 2.5 GHz
[E
1
] V/м
80 MHz to 800 MHz
80 MHz to 2.5 GHz
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 40.66 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 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 CardioMax is used exceeds the level of RF compliance used above, the CardioMax
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 CardioMax.
d
Over the frequency range 150 KHz to 80 MHz, the field intensity should be less than [V1] V/m.
Electromagnetic immunity -
Equipment with life support functions
