App. 3.8
Notes on EMC (Electromagnetic Compatibility)
•
MADSEN Alpha OAE+ is part of a medical electrical system and is thus subject to special safety precautions. For this
reason, the installation and operating instructions provided in this document should be followed closely.
•
Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the func-
tioning of MADSEN Alpha OAE+.
IEC 60601-1-2:2014 and EN 60601-1-2:2015
Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems
MADSEN Alpha OAE+ is intended for use in the electromagnetic environment specified below. The user of MADSEN Alpha OAE+ should ensure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
MADSEN Alpha OAE+ 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
MADSEN Alpha OAE+ is suitable for use in all environments, including domestic environments
and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Not applicable
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Not applicable
Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems
MADSEN Alpha OAE+ is intended for use in the electromagnetic environment specified below. The user of MADSEN Alpha OAE+ 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
+/- 2 kV, +/- 4 kV,
+/- 8 kV, +/- 15 kV air
+/- 8 kV contact
+/- 2 kV, +/- 4 kV,
+/- 8 kV, +/- 15 kV air
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humid-
ity should be at least 30 %.
Electrical fast transient/burst
IEC 61000-4-4
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
+/- 2 kV for power supply lines
+/- 1 kV for input/output lines
Mains power quality should be that of a typical com-
mercial or hospital environment.
Surge IEC 61000-4-5
+/- 1 kV line(s) to line(s)
+/- 2 kV line(s) to earth
+/- 2 kV DC input line(s) to earth
+/- 1 kV DC input line(s) to line(s)
+/- 2 kV I/O line(s) to earth
+/- 1 kV line(s) to line(s)
Not applicable
Not applicable
+/- 1 kV DC input line(s) to line(s)
Not applicable
Mains power quality should be that of a typical com-
mercial or hospital environment.
Otometrics - MADSEN Alpha OAE+
79
App. 3 Technical Specifications
