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Guidance and Manufacturer's declaration - Electromagnetic Immunity
INOmax DS
Plus MRI system (with GaussAlert™ alarms) is intended for use in the electromagnetic
IR
environment specified below. The user of the INOmax DS
assure that they are used in such an environment
Immunity Test
IEC 60601 test level Compliance
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
outside ISM bands
10 Vrms
150 kHz to 80 MHz
in ISM bands
Radiated RF
10 V/m
IEC 61000-4-3
26MHz to 1 GHz
3V/m
1GHz to 2.5GHz
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.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
a
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
b
80 MHz to 2.5 GHz are intended to decrease the likelihood that a portable communications device 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
c
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 R transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the INOmax DS
system is used exceeds the applicable RF compliance level above, the INOmax DS
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the INOmax DS
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d
Part No. 20568 Rev-02
2015-08
Plus MRI system (with GaussAlert alarms) should
IR
level
3 Vrms
Portable and mobile RF communications equipment,
including cables, should be used no closer to any
(V1)
part of the INOmax DS
a
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2*√ P
10 Vrms
d=1.2*√ P
(V2)
a
10 V/m
d=1.2*√ P
26 MHz to
80 MHz to 800 MHz
1 GHz
d=2.3*√ P
800 MHz to 2.5 GHz
3V/m
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
1GHz to
manufacturer and d is the recommended separation
2.5GHz
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
IR
Electromagnetic environment - guidance
Plus MRI system than the
IR
b
, should be less than
c
Plus MRI system should
IR
Plus MRI system.
d
Plus MRI
IR
7-7
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