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Chapter 1 Safety
EMI
Although this system has been manufactured in compliance with existing EMI (Electro-Magnetic
Interference) requirements, use of this system in the presence of an electromagnetic eld can cause
momentary degradation of the ultrasound image.
If this occurs often, Samsung Medison suggests a review of the environment in which the system is
being used, to identify possible sources of electromagnetic emissions. These emissions could be from
other electrical devices used within the same room or an adjacent room. Communication devices such
as cellular phones and pagers can cause these emissions. Nearby radios, TVs, or microwave transmission
equipment can also cause interference.
CAUTION: In cases where EMI is causing disturbances, it may be necessary to relocate this system.
EMC
The testing for EMC (Electromagnetic Compatibility) of this system has been performed according to
the international standard for EMC with medical devices (IEC 60601-1-2). This IEC standard was adopted
in Europe as the European norm (EN 60601-1-2).
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
This product is intended for use in the electromagnetic environment specied below. The user is to
ensure that the product is used in the following environment.
Emission test Compliance Electromagnetic environment - guidance
RF Emission
CISPR 11
Group 1
The Ultrasound 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.
RF Emission
CISPR 11
Class A
The Ultrasound System is suitable for use in all establishments,
other than domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
building used for domestic purpose.
Harmonic Emission
IEC 61000-3-2
Class A
Flicker Emission
IEC 61000-3-3
Complies
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