EMC Guidance and Manufacturer’s Declaration 16-1
16 EMC Guidance and
Manufacturer’s Declaration
Resona I9 series complies
with the EMC standard IEC60601-1-2:2014+A1:2020.
Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for near active HF SURGICAL
EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging).
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. 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.)
4. Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
5. Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
6. Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of Resona I9 series,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
7. Keep a distance of at least 20 cm away from the monitor when
WiFi function is in use.
8. Resona I9 series needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC
information provided below.
9. Other devices may interfere with this equipment even though they
meet the requirements of CISPR.
10. 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.
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