21
compare them with the known SpO
2
and PR values of input signal.
Note 5: Optical sensors as the light-emitting components, will affect other medi-
cal devices applied the wavelength range. The information may be useful for the
clinicians who carry out the optical treatment.For example, photodynamic therapy
operated by clinician.
EMC
Table 1:
Guidance and manufacturer’s declaration–electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The purchaser or the user of the device should assure that it is used in such environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Table 2:
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The purchaser or the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8kV contact
±15 kV air
±8kV contact
±15kV air
Power frequency
(50 / 60Hz) magnetic field
IEC 61000-4-8
30 A/m
30A/m
