PULOX PO-220B Manual Del Usuario página 41

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
Electrostatic discharge
(ESD)
IEC 61000-4-2
Power frequency
(50/60Hz) magnetic
field
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.
IEC 60601 test
Immunity test
level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80
MHz
Radiated RF 10 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.
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
RF emissions
CISPR 11
Compliance
IEC 60601 test level
level
8 kV contact 6 kV contact
8 kV, 15 kV air 6 kV air
30A/m 30A/m
Compliance
level
3 Vrms
10 V/m
Electromagnetic environment – guidance
The Pulse Oximeter uses RF energy only for its internal function.
Group 1
Therefore, its RF emissions are very low and are not likely to
Electromagnetic environment - guidance
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 magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
Electromagnetic environment - guidance
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
 
3 5 .

d   P
 
V
1
80 MHz to
 
3 5 .

 
d P
800 MHz
 
E
1
 
800 MHz to
7

 
d P
2.5 GHz
 
E
1
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.