MADSEN Alpha OAE+ Screener User Manual
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Appendix 3.7
Notes on EMC (Electromagnetic Compatibility)
MADSEN Alpha OAE+ is part of a medical electrical system and is subject to special safety precautions. 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 MADSEN Alpha
OAE+ functions.
Warning: Follow guidance and manufacturer's declaration - electromagnetic emissions for all equipment and
systems.
Caution: The Alpha OAE+ handheld Screener is intended for use in the electromagnetic environment specified
below. The user of the Alpha OAE+ handheld Screener should ensure that it is used in such an environment.
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
humidity 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
commercial 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
commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
0 % U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % U
T
; 1 cycle
and
70 % U
T
; 25/30 cycles
Single phase: at 0°
0 % U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0 % U
T
; 1 cycle
and
70 % U
T
; 25/30 cycles
Single phase: at 0°
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
MADSEN Alpha OAE+ requires continued operation
dur ing power mains interruptions, it is recommended
that the MADSEN Alpha OAE+ be powered from an
uninterruptible power supply or a battery.
Voltage interruptions on
power supply input lines
IEC 61000-4-11
0 % U
T
; 250/300 cycles
0 % U
T
; 250/300 cycles
