VOCO CELALUX 3, Directions For Use Manual

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6
Curing Light
2. Safety Notices
The Celalux 3 is only intended for use as described in this manual. Any and all other
uses constitute improper use and are the sole responsibility of the user and owner.
1. Product Description
The Celalux 3 curing light is a cordless, pen-shaped, high energy LED device intended for
the polymerization of light curing dental materials which are activated by wavelengths in
the 450 nm to 480 nm light range. It is exclusively designed for use by trained dental pro -
fessionals in the dental operatory or dental laboratory. The Celalux 3 is characterized by:
• High output of blue light
• Light weight, small compact size, and ergonomic design
• Cordless operation with easy to exchange battery packs
• Exceptionally fast recharging of battery packs
• Detachable fiber-optic light guide(s) designed for optimal intra-oral access
• Effective curing field for polymerization of light curing materials
• Convenient and easy to use recharging station with extra battery packs and built-in
radiometer
The Celalux 3 has been shipped from the manufacturer in a safe and technically sound
condition. The following directions for use must be adhered to in order: to maintain product
performance; to ensure risk-free operation; and to prevent injury to patients and dental
professionals.
1.1. Indications for Use
The Celalux 3 curing light is indicated for polymerization of dental materials which cure
with blue light (450 nm to 480 nm).
1.2. Contraindications
The Celalux 3 curing light is not for use with patients who:
A. are prone to photobiological reactions, including patients with solar urticaria or erythro-
poietic protoporphyria; or
B. are currently undergoing treatment with photosensitizing pharmaceuticals.
Anyone (users, patients, etc.) with questions, or concerns or a history of health issues con-
cerning their eyes (ex. Retinal disease, retinopathy, cataracts etc.), should consult their eye
specialist before operating or prior to receiving treatment with the Celalux 3 curing light.
Caution: For dental use only.
USA: Rx only
Made in Switzerland
Content Page
1. Product Description & Intended Use ................................................................................................ 6
1.1. Indications for use ......................................................................................................................... 6
1.2. Contraindications .......................................................................................................................... 6
2. Safety Notices ....................................................................................................................................... 6
2.1. General warnings .......................................................................................................................... 6
2.2. Handpiece ...................................................................................................................................... 6
2.3. Charging Station ........................................................................................................................... 6
2.4. Precautions .................................................................................................................................... 6
3. Operation Instructions ......................................................................................................................... 7
3.1. Owner’s Obligations ...................................................................................................................... 7
3.2. Set-up ............................................................................................................................................... 7
3.3. Charging ........................................................................................................................................... 7
3.4. Operation ......................................................................................................................................... 7
4. Dental Material Recommendations .................................................................................................. 7
5. Hygiene ................................................................................................................................................... 7
5.1. Before Patient Treatment ............................................................................................................. 7
5.2. During Patient Treatment ............................................................................................................. 7
5.3. After Patient Treatment ................................................................................................................. 7
6. General Care & Maintenance ............................................................................................................. 8
6.1. Battery Care ................................................................................................................................... 8
6.2. Repair Service................................................................................................................................ 8
7. Trouble-Shooting .................................................................................................................................. 8
8. Compliance
............................................................................................................................................. 8
8.1. Declaration of Conformity ........................................................................................................... 8
8.2. EMC Tables .................................................................................................................................... 8
8.3. Regulatory Certifications ............................................................................................................. 8
9. Technical Data ....................................................................................................................................... 8
10. Warranty ................................................................................................................................................. 8
11. Re-Order Information ........................................................................................................................... 8
12. Storage & Transport Information ....................................................................................................... 8
13. Explanation of Symbols ...................................................................................................................... 9
14. Contact Information .............................................................................................................................. 9
Annex 1 .......................................................................................................................................................... 9
Safety alert symbol
In this manual, this symbol alerts you to information regarding possible
safety and/or personal injury hazards. Obey all safety messages that follow
this symbol.
2.1. General Warnings
• Never modify the Celalux 3 curing light or any Celalux 3 accessories. Modification
may compromise safety and effectiveness.
• Maintain adequate infection control measures when using the Celalux 3 in the oral
cavity, and execute the appropriate hygiene plan after usage with patients.
• Do not use damaged equipment. Routinely check the light guide for scratches and
surface damage.
• Only authorized technicians can repair the Celalux 3 curing light, battery packs and
recharging station.
• Avoid placing the Celalux 3 or the recharging station on top, under, or close to other
equipment. A safe distance from other electrical appliance should be maintained.
• Use of accessories not mentioned in this manual may result in an unsafe conditions
and/or reduced product performance. For this reason, use only factory authorized
accessories.
• Do not charge or use the device near flammable or combustible substances.
2.2. Handpiece
• Make sure that the exit-port of the light guide is not covered by debris or items that
may block the light emission.
• Do not use the Celalux 3 light guide as a tissue retractor or as an instrument to
manipulate the tongue and/or cheeks.
• Make certain the Celalux 3 eye-protector is installed securely and inspect it rou-
tinely. Replace as needed.
• Always clean & disinfect the Celalux 3 handpiece before placing it on/in the re-
charging station.
• To change the direction of the light, rotate the handpiece as a whole, similar to rolling
a pen in your fingers or rotate the light guide independent of the handpiece.
• If not in use, always switch the battery pack into the “Off position” to avoid uninten-
tional activation.
2.3. Recharging Station
• Make certain there is a match: incoming power supply and the product electrical
requirement. Do not use the recharging station with voltages different than stated in
this manual or labeled on the equipment.
• Voltage is present in the recharging station and battery packs: do not open! Op-
erate only in dry conditions. Never use when wet.
• Installation and operate only on flat surfaces.
• Unplug the power connector from main electrical supply (ex. wall socket) before
disconnecting the power cable connector from the recharging station.
• Only touch the recharging station with clean/disinfection gloves to avoid contamina-
tion by body fluids.
• Do not use the power connector for other devices then Celalux 3 .
2.4. Precautions
• People who have undergone treatment for cataracts, have a history of photobio-
logical reactions, or who are under the influence of photosensitizing medication (ex.
8-methoxypsoralen or dimethylchloro – tetracycline), may be sensitive to light.
Such patients should not be treated with the Celalux 3 .
• Patients as well as dental professionals should always use appropriate safety pre-
cautions. Use the Celalux 3 curing light with great care and carefully comply with
all safety precautions, including wearing suitable light filtering safety glasses or gog-
gles.
• Only use the Celalux 3 after it has completed an adequate hygiene procedure.
• Do not use mobile phones or other hand-held electronic devices at the same time as
the Celalux 3 .
• Avoid directing the light at unprotected soft-tissue. This may cause irritation and/or
injury.
• Do not stare at the light source and avoid allowing the light to shine directly at eyes.
This, and reflected light from shiny surfaces such as the tooth surfaces, may injure
the eyes. Always install the eye-protector on the Celalux 3 in addition to using pro-
tective, light filtering safety glasses.
• Confine usage of the light to the area being treated.
• Prolonged usage of any curing light can increase temperature. Extended usage near
pulp and soft tissues should be avoided to prevent injury. Curing near or around
sensitive tissues should be performed with adequate breaks.
Directions for Use English