DENTSPLY SmartLite Max, Directions For Use Manual

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2.1 Warnings
1. The SmartLite ® Max L.E.D. Curing Light emits high intensity visible light radiation. Prolonged
continuous exposure to eyes, oral mucosa or exposed skin can result in injury or irritation.
When curing, position the light probe tip directly over the polymerizable material and avoid
extraneous exposure to soft tissue for prolonged periods. Wear suitable protective clothing and
eye protection designed to filter blue-violet and ultraviolet radiation. Securely attach protective
light shield before use.
Eye exposure: Avoid prolonged exposure to unprotected eyes. Prolonged exposure may cause
blurring or starring of vision, or result in visual after-image. In most cases these phenomena are
temporary and do not require treatment. If vision abnormalities persist, consult a physician.
Skin contact : Avoid prolonged exposure to skin. If skin rash, sensitization or other reaction
occurs, discontinue use and seek medical attention.
Oral mucosa contact: Avoid prolonged exposure to oral soft tissues. Prolonged exposure may
cause soft tissue irritation or burns. Most minor reactions require only thorough cleansing and
palliative treatment. If irritation persists, seek medical attention.
2. The SmartLite ® Max L.E.D. Curing Light is an electric device. To avoid electric shock:
• Do not attempt to change the Curing LED, open or alter the unit in any way (other than
as directed in these Directions for Use).
• Do not introduce any foreign objects into the housing of the unit.
• Connect the power plug into a suitably grounded and approved outlet. If using an
extension cable, make sure that the ground line is not interrupted.
• Always unplug the base/charger before disinfecting.
3. The SmartLite ® Max L.E.D. Curing Light is not suitable for use in the presence of a flammable anesthetic
mixture with air or nitrous oxide. Use in well ventilated area.
2.2 Precautions
1. This product is intended to be used only as specifically outlined in these Directions for Use. Any use of this
product inconsistent with the Directions for Use is at the discretion and is the sole responsibility of the
practitioner.
2. DO NOT look directly at the light emitted from the curing probe. As with any bright light source, staring
directly at the source may cause temporary effects such as after-image. (See Warnings)
3. It is recommended that all curing light users and patients employ suitable eye protection during operation of
the SmartLite ® Max Light. (See Warnings)
4. Persons who have had surgery for eye cataracts are especially sensitive to light and generally should not
use or be exposed to the SmartLite
®
Max Light unless they employ suitable protective measures. These
measures should include the use of spectacles that filter out blue-violet and ultraviolet light. (See Warnings)
5. Safety of the SmartLite ® Max Light has not been established in people who have been fitted with an
implanted heart pacemaker and have been cautioned against the use of small electrical appliances (such as
electric shavers, hair dryers, etc.). In these cases we recommend that the SmartLite
® Max Light not be used.
6. DENTSPLY provides light probes suitable for use with the SmartLite
®
Max Light. Other light probes must not
be used.
7. Curing probes must be maintained in a clean, undamaged condition. Probes that are scratched or damaged
in any way should not be used.
8. Use of a protective barrier sleeve over the probe lens is strongly recommended. Do not allow contact of
restorative materials with probe lens. Attempts to remove cured material from lens may scratch lens. A
contaminated or chipped/scratched lens will reduce the effectiveness of the unit.
9. Devices marked “Single Use” on the labeling are intended for single use only. Discard after use. Do not
reuse in other patients in order to prevent cross-contamination.
10. Check unit for adequate light output before each procedure. Failure to verify output may allow inadequate
curing (see Radiometer Operation section). Only the built-in radiometer should be used. Other radiometers
may give erroneous output data.
11. DO NOT IMMERSE UNIT IN WATER OR DISINFECTANT. Do not spray liquids directly onto the light. Spray
a towel, then wipe the light. Prevent liquids from entering openings on unit, especially the socket for the
probe. Always wipe the unit with the probe installed.
12. Should the SmartLite
®
Max Light become damaged in any way, do not attempt to operate the unit unless
thoroughly inspected and serviced by qualified DENTSPLY Service personnel.