CONTEC MEDICAL SYSTEMS CO.,LTD
5
Guidance and manufacturer’s declaration – electromagnetic immunity –for
pulse oximeter probe that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The pulse oximeter probe
is intended for use in the electromagnetic environment specified below. The customer or the
user of pulse oximeter probe should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the pulse
oximeter probe, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
P
d
2
.
1
=
P
d
2
.
1
=
80 MHz to 800 MHz
P
d
3
.
2
=
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 pulse oximeter probe is used exceeds the applicable
RF compliance level above, the pulse oximeter probe should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the pulse oximeter
probe.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
