App. 1.3
Notes on EMC (Electromagnetic Compatibility)
•
AURICAL OTOcam 300 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 AURICAL OTOcam 300.
IEC 60601-1-2:2014 and EN 60601-1-2:2015
Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems
AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below. The user of AURICAL OTOcam 300 should ensure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
AURICAL OTOcam 300 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
AURICAL OTOcam 300 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
AURICAL OTOcam 300 is intended for use in the electromagnetic environment specified below. The user of AURICAL OTOcam 300 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
+/- 1 kV for input/output lines
+/- 1 kV for input/output lines
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
30 A/m
No relevant ports that could be
affected
Power frequency magnetic fields should be at levels char-
acteristic of a typical location in a typical commercial or
hospital environment.
Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment
28
Otometrics - AURICAL OTOcam 300
App. 1 Technical Specifications
