Adverse Reactions - KERR Demi Ultra Instrucciones De Uso

• Check the LED Light Attachment for adequate light output before each procedure. Failure
to verify output may allow inadequate curing (see Product Testing section). Only the Demi
Ultra built-in radiometer or a Demetron Radiometer (part number 910726) should be
used. Other radiometers may give erroneous output data and cannot be relied upon to test
Demi Ultra output.
• Consult with a physician prior to exposing a patient, or user, to the Demi Ultra if patients,
or users, are fitted with implanted or external medical devices.
• The System must be maintained in a clean, undamaged condition. An unclean or damaged
unit should not be used. Do not attempt to operate a damaged System until it has been
thoroughly inspected and serviced by qualified service person.
• To prevent cross-contamination, use an FDA cleared disposable plastic sleeve (provided)
over the LED Light Attachment during each use. Do not allow restorative materials to
contact the lens on the end of the LED Light Attachment. Attempts to remove cured
material may scratch the lens. A contaminated or chipped/scratched lens will reduce the
effectiveness of the unit and could result in a restoration that is not cured completely.
• Items, including Barrier Bags, labeled as "Single Use" or "Do Not Re-use" are intended for
single use only. Discard after use. In order to prevent cross-contamination, do not re-use
with other patients.
• Do not immerse any system components in water or disinfectant.
• Do not spray liquids directly onto the System components. Spray a towel, then wipe the
light. Prevent liquids from entering openings on unit, for example the Magnetic Socket for
the LED Light Attachment. Always clean the unit with the LED Light Attachment installed.
• If the Demi Ultra is moved from a cold to a warm environment condensation on the inside
of the unit may be a potential risk. In such instances, the product should be brought to
ambient temperature before charging and/or operation.
• Do not look directly at the light emitted from the LED Light Attachment. As with any bright
light source, staring directly at the source may cause temporary effects such as after-image
(See Warnings).
• It is recommended that all curing light users and patients employ suitable eye protection
during operation of the Demi Ultra. (See Warnings for information on suitable eyewear.)
• This product was developed to comply with relevant EMC regulations and standards and
has been tested to verify its conformity with legal requirements. However, the possibility
of EMC disruptions cannot be completely excluded due to variables that may exist within
the work environment, such as power supply, wiring, and other ambient conditions. If you
should experience problems in the operation of this product, move the unit to a different
location. See the appendix for the EMC manufacturer´s declaration and the recommended
separation distances between the Demi Ultra and portable and mobile RF communications
equipment.
• The Demi Ultra Charging Dock should not be stored within the patient environment as a
precaution against inadvertent electric shock (as shown in the figure below).

ADVERSE REACTIONS

None known.
PRODUCT SETUP AND FIRST-TIME USE
Power Supply Assembly
The power supply is a universal-input unit that accepts 100V – 240V AC nominal.
NOTE: Only Kerr-supplied power supplies are to be used to power the Demi Ultra. There are two types of power
supplies available. The power supplies differ slightly in appearance, but operate the same both electrically and
mechanically.
1.5m 1.5m
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