AirSep FreeStyle Patient Manual page 47

EN
Guidance and manufacturer's declaration ± electromagnetic immunity
The FreeStyle is intended for use in the electromagnetic environment specified below. The customer or the user of the
FreeStyle should assure that it is used in such an electromagnetic environment.
IMMUNITY
test TEST LEVEL
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to
80 MHz
Radiated RF 3 V/m
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 is used
exceeds the applicable RF compliance level above, the FreeStyle 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.
b.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
EN-44
IEC 60601 Compliance
3 Vrms
3 V/m
Electromagnetic environment ± guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the FreeStyle
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 survey
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
FreeStyle™
®
AirSep Corporation
MN131-1 rev. B - 02/13
a
should