4
LED Dental Curing Lights
RISK GROUP 2
CAUTION: Possibly hazardous optical radiation emitted from this
product. Do not stare at operating lamp. May be harmful to the eyes.
Classification
• Conforms to IEC 60601-1, IEC 60601-1-2, IEC 62471
FCC Statement
This device complies with part 15 of the FCC rules. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Unpacking / Setup
1. Ensure all parts contained within package match the contents list.
2. Plug the AC/DC wall plug adapter into the mating connector on the
back of the charger base.
3. Plug the AC/DC wall plug adapter connector into an AC outlet.
4. Place the Flashlite LED Curing Light into the charger base. Allow
the Flashlite LED Curing Light to fully charge prior to first use.
Refer to Techical Data for charge times. Indicator will turn green
when unit is fully charged. Store light in charger when not in use.
NOTE: The AC/DC wall plug adapter provides power to the charger base. In
turn, the charger base provides power (at a lower voltage) to the Flashlite
LED Curing Light. These form a Medical Device System. The Flashlite Curing
Light device is used separately after fully charged.
Operation
The Flashlite LED Curing Light is supplied with the lens cap attached.
A button on the Flashlite LED Curing Light turns the light on and off.
Simply press the button once and release to activate or de-activate
the light. A clean barrier sleeve must be used for each new patient
use. Aim the beam at the area of the oral cavity in which clinical
treatment is intended and activate the light. Deactivate the light right
after treatment. Do not touch the tip to the patient especially during
and after activation of the light.
WARNING: The curing intensity of the FLASHlite LED Curing Light can
result in a buildup of heat around the tip of the device. In worst case
conditions (which included 32°C ambient conditions), tip temperatures
of 61°C (142°F) have been measured. Do not use on patients who
cannot give immediate and clear feedback to the clinician in the event
any elevated temperatures are causing pain. Use extreme caution if
using on patients with increased oral heat sensitivity or with conditions
or medications which might cause increased oral heat sensitivity. This
device is for professional use only.
Warnings and Precautions
1. The Flashlite LED Curing Light must be used in strict
accordance with the following operating instructions. DenMat
accepts no liability for any damage resulting from the use of
this unit for any purpose.
2. Exposure must be restricted to the area of the oral cavity in
which clinical treatment is intended.
3. Do not touch the tip to the patient especially during and after
activation of the light. Do not point the light into the eyes.
4. Avoid having the Flashlite LED curing light in contact with
the patient.
5. The use of third party chargers and/or AC/DC wall plug
adapters may result in damage to the unit, may be hazardous
to users/patients and will void warranty. Use only supplied wall
plug adapter with the supplied charger for Flashlite LED curing
lights. Do not use wall plug adapter to power other devices.
6. Removing the wall plug adapter from the wall outlet is the
means of isolating this Flashlite LED Curing Light from the
supply means.
7. Do not allow cleaning agents to directly enter the unit as this
may cause premature failure. See Maintenance and Care.
8. Do not use on patients with a history of heat sensitivity or
photo biological conditions including urticarial solaris or
erythropoetic protoporphyria or are on photosentisizing
medications.
9. Suitable blue-filtering safety goggles must be worn by patient
and dentist during use.
10.Do not use any of these components/devices if damaged or
potentially damaged from impact.
11. Only a DenMat Authorized Representative can service the unit.
Please call DenMat with any questions. Phone numbers are on
the back of this manual.
WARNING: No modification of this equipment is allowed.
