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9. Specifications and electrical ratings
Guidance and manufacturer’s declaration -
electromagnetic compatibility
The Jazz Ultra Otoscope and Ophthalmoscope have been tested
regarding their ability to operate in an environment containing other
electrical/electronic equipment (including other medical devices).
The purpose of this testing is to ensure the Jazz Ultra Otoscope
and Ophthalmoscope are not likely to adversely affect the normal
operation of other such equipment and that other such equipment is
not likely to adversely affect the normal operation of the Jazz Ultra
Otoscope and Ophthalmoscope.
Despite the testing of the Jazz Ultra Otoscope and Ophthalmoscope
that has been undertaken, normal operation of the Jazz Ultra
Otoscope and Ophthalmoscope can be affected by other electrical/
electronic equipment and portable and mobile RF communications
equipment.
As the Jazz Ultra Otoscope and Ophthalmoscope are classed as
medical equipment, special precautions are needed regarding EMC
(electromagnetic compatibility).
It is important that the Jazz Ultra Otoscope and Ophthalmoscope
are configured and installed/put into service, in accordance with
the instructions/guidance provided herein and are used only in the
configuration as supplied.
The Jazz Ultra Otoscope and Ophthalmoscope have been tested (and
should be used only with) the Jazz Ultra battery handle and lamp
supplied.
If the Jazz Ultra Otoscope and Ophthalmoscope are used with battery
handles other than the one supplied, or with lamps other than those
recommended, this may result in increased emissions or decreased
immunity of the Jazz Ultra Otoscope and Ophthalmoscope, in relation
to EMC performance.
It should be noted that the Jazz Ultra battery handle and lamps provided
with the Jazz Ultra Otoscope and Ophthalmoscope should not be used on
other equipment. To do so may result in increased emissions or decreased
immunity of the other equipment in relation to EMC performance.
The Jazz Ultra Otoscope and Ophthalmoscope should not be used
adjacent to or stacked with other equipment. If adjacent or stacked
use with other equipment is necessary, the Jazz Ultra Otoscope and
Ophthalmoscope and the other equipment should be observed/
monitored, to verify normal operation in the configuration in which it
will be used.
For the purposes of EN60601-1-2, the Jazz
Ultra Otoscope and Ophthalmoscope have
an essential performance. This
essential performance is that the
light output should remain on.