Guidance and Manufacturer’s Declaration
Electromagnetic Emissions and Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document.
Portable and mobile RF communication equipment can affect Medical Electrical equipment.
The above two warnings are also in the Instructions for Use.
This declaration applies for the Sleep Mask device.
The requirements for essential performance of the device are:
- after the EMC test the units should automatically return to normal function.
- during normal use deviations in normal operation would be an inconvenience rather than endangering life or well being.
Warning
- The use of accessories, transducers and cables other than those specified could result in increased emission or decreased immunity of the device.
- The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the Sleep Mask should be observed to verify normal operation in the configuration in which it will be used.
