Interacoustics Luna - Page 44

D-0128842-E – 2023/10
Luna - Instructions for Use - US Page 41
Guidance and manufacturer’s declaration — electromagnetic immunity
The Instrument (Luna) is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument
should assure that it is used in such an environment,
Immunity test
IEC / EN 60601 test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
parts of the Instrument, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC / EN 61000-4-6
3 Vrms
150kHz to 80 MHz
3 Vrms
 =
3,5

√

6 Vrms
In ISM bands (and amateur
radio bands for Home
Healthcare environment.)
6 Vrms
Radiated RF
IEC / EN 61000-4-3
3 V/m
80 MHz to 2,7 GHz
3 V/m
 =
3,5
/
√

80 MHz to 800 MHz
 =
7
/
√

800 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
Only for Home Healthcare
environment
10 V/m
(If Home Healthcare)
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,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE1 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)
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
Instrument is used exceeds the applicable RF compliance level above, the Instrument should be observed to verify normal operation, If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Instrument.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.