D-1
Appendix D Guidance and
Manufacturer's Declaration
The system complies with the EMC standard IEC60601-1-2: 2007.
WARNING:
The use of unapproved accessories may diminish system
performance.
NOTE: Use of accessories, transducers, and cables other than those specified
may result in increased emission or decreased immunity of system.
The system should not be used adjacent to or stacked with other
equipment. If adjacent or tacked use is necessary, system should be
observed to verify normal operation in the configuration in which it will be
used.
The system needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
below.
Preventing conducted RF immunity. Due to technological limitations, the
conducted RF immunity level are limited to 1Vrms level, conducted RF
interference above 1Vrms may cause wrong diagnosis and measurements.
We suggest that you position system further from sources of conducted RF
noise.
Operation of system, in the case that the patient physiological signal is
lower than the minimum amplitude or value specified in the product
specifications, may cause inaccurate results.
Portable and mobile RF communications equipment can affects system.
See tables 1, 2, 3, and 4 below.
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