
Full Digital Ultrasonic Diagnostic Instruments
User’s Manual V1.00
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Chapter
Sixteen
Guidance and Manufacturer’s Declaration
This product complies with EMC test standard EN60601-1-2
Table 1 - Guidance and manufacturer’s declaration—electromagnetic emission
This equipment is intended for use in the electromagnetic environment specified below.
Customer or user shall assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
This equipment 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 A
This equipment is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies building used
domestic purposes.
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations/flicker
Emissions IEC61000-3-3
Complies
Warning:
The use of inappropriate accessory will reduce the performance of the
product.
Attention:
1. The use of the accessory, transducer or cable other than those specified may result in
increased emissions or decreased immunity of the system.
2. The system should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the system should be observed to verify normal
operation in the configuration in which it will be used.
3. The system needs to be specifically for EMC protection, and need to be installed and
maintenance in the environment meeting the following provided EMC information.
4. The system may be interfered with by other equipment, even if that other equipment
complies with CISPR emission requirements.
5. Prevent electromagnetic interference (Conducted Immunity). Due to technical
limitations, conducted immunity level is limited to 1 Vrms, conducted immunity level
higher than 1 Vrms may cause the image display of the system interference and
affecting the diagnosis and measurement. We recommend the system away from the
conduction noise source.
6. Operation of the system below minimum amplitude or value of patient physiological
signal may cause inaccurate results.
7. Portable and mobile communications equipment can affect the performance of the
system. See the following tables 1, 2, 3, 4.