EMC Guidance and Manufacturer’s Declaration 16-1
16 EMC Guidance and
Manufacturer’s Declaration
The system complies with the EMC standard IEC 60601-1-2: 2014.
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).
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 m V.)
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 the
system,including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
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