Appendix
The equipment complies with the requirements of standard EN60601-1-2 „Electromagnetic
Compatibility – Medical Electrical Equipment“
Guidance and manufacture’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of Pulse Oximeter should ensure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
8 kV contact
8 kV,
15 kV air
6 kV contact
6 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Power frequency
(50/60Hz) magnetic
field
30A/m
30A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacture’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer or the user of Pulse Oximeter should ensure 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
3 Vrms
150 kHz to 80
MHz
3 Vrms
Portable and mobile RF communications equipment
should be used no closer to any part of the Pulse
Oximeter, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5
GHz
10 V/m
80 MHz to
800 MHz
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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnet.
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.
Guidance and manufacture’s declaration – electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
customer of the user of the Pulse Oximeter should assure that it is used in such and environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The Pulse Oximeter uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
P
V
d
1
5
.
3
P
E
d
1
5
.
3
P
E
d
1
7