CAIRE AirSep FreeStyle 5, Patient Manual

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FreeStyle 5™ EN
MN167-1 rev. D EN-41
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.
IMMUNITY
test
IEC 60601
TEST LEVEL
Compliance
level
Electromagnetic environment ± guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3 3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz 3 Vrms
3 V/m Portable and mobile RF communications
equipment should be used no closer 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
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
surveya 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:
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.