Appendix C: Guidance and Manufacturer’s Declaration
Pulse Oximeter for Sleep Screening Operation Manual
C-1
Appendix C: Guidance and Manufacturer’s Declaration
Guidance and Manufacturer’s Declaration
The 3403 pulse oximeter is intended for use in the electromagnetic environment specified in the
tables within this appendix.
NOTE! The customer or user of the 3403 pulse oximeter should ensure that it is used in
such an environment.
Electromagnetic Emissions - Emissions Test
EMISSIONS TEST COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT GUIDANCE
RF emissions
CISPR 11
Group 1
The 3403 pulse oximeter uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The 3403 pulse oximeter is suitable for use in all establishments,
including:
Domestic establishments.
Establishments directly connected to the public low-
voltage power supply network that supplies buildings
used for domestic purposes.
•
•
Harmonic emissions
IEC 61000-3-2
NA
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
NA
Electromagnetic Emissions – Immunity
IMMUNITY
ELECTROMAGNETIC ENVIRONMENT
GUIDANCE
Electrostatic discharge (ESD)
IEC 61000-4-2
IEC 60601 TEST LEVEL Floors should be made of:
Wood
Concrete
Ceramic tile
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
•
•
•
± 6 kV contact
± 8 kV air
•
•
COMPLIANCE LEVEL
± 6 kV contact
± 8 kV air
•
•
