Chapter 2. Safety 2 – 11
2.3.4. EMI
Although this system has been manufactured in compliance with existing EMI (ElectroMagnetic
Interface) requirements, use of this system in the presence of an electromagnetic field can
cause degradation of the ultrasound image or product damage.
If this occurs often, Samsung Medison suggests a review of the environment in which the
system is being used, to identify possible sources of radiated 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. The
existence of radios, TVs, or microwave transmission equipment nearby can also cause
interference.
In cases where EMI is causing disturbances, it may be necessary to relocate this
system.
2.3.5. 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).
2.3.5.1. Guidance and Manufacturer’s Declaration – Electromagnetic Emission
This product is intended for use in the electromagnetic environment specified below. The
customer or the user of this product should ensure that it is used in such an environment.
Em i ssi on Te st Compliance Electromagnetic Environment – Guidance
RF Emission
CISPR 11
Group 1
The Ultrasound System uses RF energy only for its
internal functions. 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 and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic Emission
IEC 61000-3-2
Class A
Flicker Emission
IEC 61000-3-3
Complies
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