otometrics MADSEN Alpha OAE, User Manual

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App. 3.8 Notes on EMC (Electromagnetic Compatibility)
• 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 Alpha OAE.
Guidanceand manufacturer's declaration - electromagnetic emissions for all equipment and systems
Alpha OAE is intended for use in the electromagnetic environment specified below. The user of Alpha OAE should ensure that it isused in such an environment.
Emissionstest Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
Alpha OAE uses RF energy only for its internal function. Therefore, its RF emissionsare very low and are
not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
Alpha OAE is suitable for use in all environments, including domestic environments and those directly
connected to public low-voltage power supply networksthat supply buildingsused for domestic pur-
poses.
Guidanceand manufacturer's declaration - electromagnetic immunity for all equipment and systems
Alpha OAE is intended for use in the electromagnetic environment specified below. The user of Alpha OAE should ensure that it isused in such an environment.
Immunitytest IEC 60601
test level
Compliancelevel Electromagnetic environment - guidance
Electrostatic
discharge(ESD) IEC
61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should bewood, concrete or ceramic tile. If floors are covered with synthetic
material, the relativehumidity should be at least 30%.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical loc-
ation in a typical commercial or hospital environment.
Note
•
U
T
is the AC mains voltage prior to application of the test level.
62 Otometrics - MADSEN Alpha OAE
App. 3 Technical Specifications