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Electromagnetic Compatibility (EMC)
The Sapphire Series® Static Low-Air-Loss Mattress Replacement System has been tested for
compliance with the EMC requirements. The guidelines in this section will help to ensure the
medical equipment will meet the requirements of the standard.
WARNING:
Medical equipment should not be used, stacked or located on or
around equipment that may create electromagnetic interferences.
Emissions
The blower has been type tested and has passed the requirements of CISPR 11. Observe the
following recommendations to minimize radio frequency emissions.
Immunity
The blower has been stringently tested for susceptibility to electromagnetic radiation over the
frequency range 80 MHz to 2.5 GHz. The test was conducted on this blower and passed the
requirements of IEC 61000-4-3.
All pins of connectors have passed ESD testing.
List of Cables and Accessories
Replacement parts, such as cables and accessories, must be purchased through Sunflower
Medical L.L.C. to ensure proper compliance requirements.
WARNING:
Using other manufacturers’ cables and accessories may affect EMC
performance. Unauthorized use of these items will void warranty and could result
in patient and/or user injury as well as damage to equipment or other property.
The use of cables or accessories other than those for which the blower was
designed or tested can significantly degrade emissions and immunity
performance.
GUIDANCE AND MANUFACTURER’S DECLARATION
Company:
Sunflower Medical LLC
Model:
Pulse
Control Number:
3101425