MEDIPREVENTIECENTRUM Pulse Oximeter Instructions To User - page 15
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Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The CMS50QA
Pulse Oximeter
is intended for use in the electromagnetic environment specified below. The customer or the user of
CMS50QA
Pulse Oximeter
should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the CMS50QA
Pulse
Oximeter
, including cables, than the recommended
separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
P
V
d
=
1
5
.
3
P
E
d
=
1
5
.
3
80 MHz to 800 MHz
P
E
d
=
1
7
800 MHz to 2.5 GHz
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,
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:
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 CMS50QA
Pulse Oximeter
is used exceeds the applicable RF compliance level
above, the CMS50QA
Pulse Oximeter
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the CMS50QA
Pulse Oximeter
.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.