Manufacturer's Declaration; Electromagnetic Emissions; Electromagnetic Immunity - Somnetics Transcend User Manual

Page 48

Manufacturer's declaration

This section presents the following topics:
•

Electromagnetic emissions

•

Electromagnetic immunity

•
EN 60601-1 compliance
Electromagnetic emissions
The CPAP system is intended for use in the electromagnetic environment specified below. The customer or the
user of the CPAP system should ensure that it is used in such an environment.
Emissions test
RF radiated emissions
CISPR 11
RF conducted emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Electromagnetic immunity
The CPAP system is intended for use in the electromagnetic environment specified below. The customer or the
user of the CPAP system should ensure that it is used in such an environment.
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Appendix: Specifications
(page 48)
(page 48)
(page 50)
Compliance Electromagnetic environment—guidance
Group 1 The CPAP system 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.
Class B The CPAP system is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
Class A
domestic purposes.
Complies
IEC 60601 test level Compliance level
±2, 4, 6 kV contact N/A. The CPAP system
does not have conductive
surfaces.
±8 kV air ±2, 4, 6, 8 kV air
±2 kV for power supply ±2 kV for power supply lines
lines
±1 kV for input/output ±1 kV for input/output lines
lines
±1 kV differential mode ±0.5*, 1 kV differential mode
±2 kV common mode ±2 kV common mode
Sleep Apnea Therapy User Manual
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%.
Line power quality should be that of a
typical commercial or hospital
environment.
Line power quality should be that of a
typical commercial or hospital
environment.