Guidance and Manufacturer’s Declaration 16-1
16 Guidance and Manufacturer’s
Declaration
The system complies with the EMC standard IEC 60601-1-2: 2007.
WARNING:
1. The use of unapproved accessories may diminish system
performance.
2. Use of components, accessories, probes, and cables other than
those specified may result in increased emission or decreased
immunity of system.
3. 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.
4. Operation of system, in the case that the patient physiological
signal is lower than the minimum amplitude or value specified in
the product specifications, results may not be obtained (results
can be obtained when the HR is in the range of 30-250 bmp or
when the QRS wave amplitude is between 0.5-5 mV.)
NOTE: 1 The system needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided below.
2 Other devices may interfere with this system even though they meet the requirements
of CISPR.
3 Preventing conducted RF immunity. Due to technological limitations, the conducted
RF immunity level are limited to 3Vrms level, conducted RF interference above 3Vrms
may cause wrong diagnosis and measurements. We suggest that you position system
further from sources of conducted RF noise.
4 Portable and mobile RF communications equipment can affects system. See tables 1,
2, 3, and 4 below.
If the system is operated within the electromagnetic environment listed in Table 2 and Table 3, the
system will remain safe and will provide the following basic performances:
z Imaging;
z Doppler acoustic spectral displaying;
z Taking measurements;
z Patient information;
z Date/time information.
To Next Page
Loading...
Need help?
General
