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Chapter Fourteen Guidance and Manufacturer’s Declaration
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Table 1 - Guidance and manufacturer’s declaration—electromagnetic emission
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Emission test Compliance
Electromagnetic environment - guidance
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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.