Guidance and Manufacturer’s Declaration 15-1
15
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:
1 Use of accessories, transducers, and cables other than those specified may
result in increased emission or decreased immunity of system.
2 The system or its components should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the system or its
components should be observed to verify normal operation in the configuration in
which it will be used.
3 The system needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided below.
4 Other devices may interfere with this system even though they meet the
requirements of
CISPR
.
5 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.
6 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.
7 Portable and mobile RF communications equipment can affects system. See
tables 1, 2, 3, and 4 below.
