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Electromagnetic compatibility – AirSep Eclipse 5 20631679 User Manual

Page 9

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Personal Ambulatory Oxygen System Provider Technical Manual

9

PN 20631679 Rev C

ELECTROMAGNETIC COMPATIBILITy

This equipment has been tested and found to comply with the limits for medical devices to the IEC60601-1-2 Electromagnetic
Compatibility standard. These limits are designed to provide reasonable protection against harmful interference in a typical
medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed according to the
instructions, may cause harmful interference to other devices in the vicinity. There is, however no guarantee that interference will
not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined
by turning the equipment off and on, the User is encouraged to try to correct the interference by one or more of the following
measures:

Reorient or relocate the receiving device.

Increase the separation distance between the equipment.

Connect the equipment into an outlet on a circuit different from that which the other device(s) are connected.

Consult with Chart SeQual’s Technical Support Department for help.

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 manual.

Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

The use of Accessories, transducers, and cables other than those specified, with the exception of transducers and cables sold by
the Manufacturer of this device as replacement parts for internal components, may result in increased Emissions or decreased
Immunity of the Eclipse 5.

The Eclipse 5 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the
Eclipse 5 should be observed to verify normal operation in the configuration in which it will be used.

Guidance and Manufacturer’s Declaration -
electromagnetic emissions

The Eclipse 5 is intended for use in the electromagnetic environment specified below. The customer or the user of the
Eclipse 5 should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions
EN 55011

Group 1

The Eclipse 5 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.

RF emissions
EN 55011

Class B

The Eclipse 5 is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low - voltage power supply network that supplies
buildings used for domestic purposes.

Harmonic emissions IEC
61000-3-2

Class A

Voltage fluctuations/
flicker emissions IEC
61000-3-3

Complies