3B Medical Line II QX Series User Manual page 40

Luna II QX CPAP / Luna II QX Auto CPAP User Manual V1.1
Luna II QX CPAP / Luna II QX Auto CPAP User Manual V1.1
Guidance and manufacturer's declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified
below. The user of the device should make sure that it is used in such an
environment.
Immunity IEC
Test Test Level
3 V
0.15 MHz ～
80 MHz
6 V in ISM
Conducted
and
RF
amateur
IEC
radio bands
61000-4-6
between
0.15 MHz
and 80 MHz
Radiated RF
IEC
61000-4-3
10 V/m
80 MHz to
2.7 GHz
Note 1: At 80 MHz and 800 MHz, the higher frequency range applied.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
Field strengths from fixed transmitters, such as base stations for radio (cellular /
a
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 device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, the field strengths should be less
b
than 10 V/m.
60601 Compliance
Level
3 V
0.15 MHz ～
80 MHz
6 V in ISM
and
amateur
radio bands
between
0.15 MHz
and 80 MHz
10 V/m
80 MHz to 2.7
GHz
Electromagnetic Environment -
Guidance
Portable and mobile
communications
should be used no closer to any
part of the device, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended
distance
d p
= . 1 17
80 MHz to 800 MHz
d = . 0 35 p
800 MHz to 2.5 GHz
d = . 0 70 p
Where P is the maximum output
power rating of the transmitter in
watts (W) according
transmitter manufacturer and d is
the recommended
distance in meters (m).
Field strengths from
transmitter, as determined by an
electromagnetic site survey,
should be less
compliance level
frequency range.
b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
RF
equipment
separation
to the
separation
fixed RF
a
than the
in each