AirSep FreeStyle 5 Patient Manual page 36

Guidance and manufacturer's declaration ± electromagnetic immunity
The FreeStyle 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the FreeStyle 5 should assure
that it is used in such an electromagnetic environment.
IEC 60601
I test
MMUNITY
LEVEL
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
3 V/m
Radiated RF
IEC 61000-4-3
80 MHz to 2.5 GHz
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. 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 FreeStyle 5 is used exceeds the applicable RF compliance level above, the FreeStyle 5
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the FreeStyle 5.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
MN166-1 rev A 11/12
Compliance
TEST
Electromagnetic environment
level
Portable and mobile RF communications equipment should be used no closer
3 Vrms
to any part of the FreeStyle 5 including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
D= 1.2 x P
3 V/m
D= 1.2 x P from 80MHz to 800MHz
D= 2.3 x P from 800MHz to 2.5GHz
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 metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic
site survey
Interference may occur in the vicinity of equipment marked with the following
symbol:
±
guidance
a
should be less than the compliance level in each frequency range.
b
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