Gnatus Optilight LD Max User manual

DEAR CUSTOMER
Congratulations. You have made a good choice when you decided to buy a GNATUS QUALITY product comparable to the best products available in the World. This manual is a general presentation of your product and it will give you important details to help you to solve possible problems.
Please, read it and keep this with you.
PRODUCT DESCRIPTION
Unlike traditional devices, which generate wide-spectrum light and heat, this technology uses a cold light of the precise wave length needed to activate various dental products.
LED technology, which was recently introduced in Dentistry, brought about several useful features to those light-curing devices used in composite resin restoration. Besides being more durable, LED technology turned devices more compact, ergonomic and easier to install and transport. The emission of cold light within a precise wave length range ensures the safe cure of camphorquinone-activated composites, preventing dental heating, pulp damage or discomfort for both patient and dentist. Although being relatively new, this technology is nowadays in its second generation. LED safety and efficiency, now allied to high­energy emission, are available to all clinic procedures which require light-curing power, including bleaching treatments.
The light of 440nm-460nm wave length, allied to the high energy emitted by Optilight LD Max, makes possible the multi-functionality of this device:
- Direct restoration procedures: composite resins, ionomers and adhesives.
- Indirect restorations: adhesive cementation of laminates, inlays, esthetic pins and metal-free
crowns.
- Dental Bleaching: activation of bleaching gel and polymerization of gingival barriers. Compatible
with 35% hydrogen peroxide-based bleaching gels.
- Attachment of braces and orthodontic accessories.
- Activation of light-cure materials, such as sealants, surgical cements and covering bases.
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Designed and built with cutting-edge technology, it meets the highest standards specified by world’s dental authorities.
It features an automatic bi-voltage power supply, which allows operation in the range of 90 to 240 V AC, 50/60 Hz.
Operation control display in handpiece, sound alarm with beep every 10 seconds and 4 beeps at the end of the cycle.
Advantages offered by Optilight LD Max:
- More spectrally-selective light than conventional lamps.*
- Cold light, it doesn’t heat up the resin nor the tooth**
• Light compact equipment that provides handling comfort.
• Low power consumption.
• Longer useful life of the light emitting diode (equivalent to 36.000.000 cycles of 10 seconds).
• It does not use optical filter.
• It does not require forced ventilation, thus avoiding noise emission.
* We noted that the light emitted by the Optilight LD Max is completely contained within the absorption interval of the photo starter, therefore it’s 100% used, whereas the conventional equipment running on halogen lamps has non-used wave-length regions.
** The Optilight LD Max doesn’t generate heat since it uses light emitting diodes.
The light conductor is removable, made out of high resistance polymer and of easy maintenance.
The handpiece’s low weight and its anatomic design ensure the dentist more comfortable and practical handling.
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PRODUCT DESCRIPTION
The handpieces’s support makes access and handling easier. ISO 9001/2000 and ISO 13485/2003 Quality System, ensures that products are manufactured under
standard procedures.
Products manufactured in compliance with RDC 59 - ANVISA - (Sanitary Surveillance National Agency)
- which guarantees compliance with sanitary regulations concerning BPF - (Good Manufacturing Practices), requested by Mercosul Sanitary authorities.
Note: Use handpieces and accessories that comply with requirements of directive 93/42/EEC (with
CE mark).
IMPORTANT:
· This equipment is exclusively for dental use. It must be operated and handled by specialized professionals (certified professionals, according to the legislation of the country) and the instructions contained in this manual shall be observed. User shall always use tools and instruments in perfect working conditions, and he/she shall protect himself/herself and patients from any possible danger.
· This equipment can’t be used in the presence of inflammable anesthetics or products that may cause explosions.
· When this device comes to the end of its useful-life, it shall be dumped in an appropriate location (according to the legislation of the country).
·To ensure the safe operation of your equipment, use only the assemble configurations (Dental Chair, Dental and Water Units and Dental Light) supplied by Gnatus authorized Dealers / Technical Assistance.
WARRANTY OF THE EQUIPMENT
This warranty covers product’s manufacturing faults for the warranty period and standards specified on the Warranty Certificate. The Warranty Certificate is attached to product, and must be completed by the authorized technician when equipment is installed.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
GENERAL DATA
Maintenance of the equipment
The equipment doesn’t need preventive maintenance, however when there is any problem that this manual can’t solve, ask for an authorized Gnatus technician.
List of pieces and circuit scheme
Gnatus Company declares that the supply of the circuit scheme, list of pieces or any other information that propitiate technical attendance for the user, can be request if there is an agreement between the user and Gnatus Company.
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GENERAL DATA
01
01 - Power Supply 02 - Cable PP - (2.20m) 03 - Optilight LD Max body 04 - Pen 05 - Ocular protector 06 - Light conductor
02
03
05
06
04
08
09
10
07 - Light conductor Whitening Tip
08 - Display
09 - On/Off timer button
10 -Time selection
07
Whitening
Tip
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TECHNICAL SPECIFICATIONS
Power supply
Ve: 90V~-240V~
Vs: 5,0V. 1,2 A.
Frequency
50/60Hz.
Power
15VA
Light source
1 LED.
Active medium
Semiconductor Led (InGaN).
Wavelength
440nm - 460nm
Timer
90 seconds.
imer alarm
sound alarm with beep every 10 seconds and 4 beeps at the end of the cycle.
Warning:
The acrylic light conductor (pointer) is a material widely used in the dentist industry in partial and
complete prosthesis, orthodontic device, implants and many other applications that guarantees its bio-compatibility with the mouth mucus.
Activation
Through the hand-piece button.
Light conductor Made out of special polymer, ro-
tational, removable and reuse sable.
Hand-piece body
ABS injected
Net weight
0.82 kg
Gross weight
1.36 kg
Product classification:
In compliance with NBR IEC 60601-1
Degree of protection
against electric shock:
B type
Electric shock protection
type:
Class two equipment.
Water leak protection
IPX 0
Application together with
anesthetic products that could be inflammable in the presence of air, oxygen or nitrous oxide:
Not recommended
Applied norms: This product was tested and approved in compliance with the following standards:
EN 60601-1 (1990); Amendment 1 EN 60601-1 (1992); Amendment 2 EN 60601-1 (1995); Amendment13 EN 60601-1 (1995); EN 60601-1-2 (2001);
This equipment was designed, manufactured and tested in compliance with the following standards: NBR-IEC série 601-1 Equipamento Eletromédico - Parte 1: Prescrições gerais para segurança; EN 980:2003 (Ed. 2) - Graphical symbols for use in the labelling of medical devices; ISO 14971 - Medical devices - application of risk management medical devices; ISO 9687: 1993 - Dental equipment - graphical symbols; ISO 7494 - Norma dental units; ISO 13485-2 - Quality systems - medical devices; ISO 780 - Packaging - pictorial marking for handling goods; ISO 11144 - Norma dental equipment - connections for suply and waste lines;
NBR IEC 601-1 (1994); Emend a 1 NB R IE C 601 -1
(1994); NBR IEC 601-1-2 (1997); CISPR 11, edição 3.1 (1999);
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IEC 61000-4-2 (1999); IEC 61000-4-3 (1998); IEC 61000-4-4 (1995); IEC 61000-4-5 (1995); IEC 61000-4-6 (1996); IEC 61000-4-11 (1996);
TECHNICAL SPECIFICATIONS
Special providence or particular conditions for installation
- Check the electric net, it must be compatible with the specified one in the equipment.
- Verify the general key of the equipment in the position “0”. OBS: These information also make part of the Manual of Installation and Maintenance of the equipment
that can be found with the authorized Gnatus technician.
Transport and storage conditions
The equipment must be transported and stored with the following observations:
- Carefully, should not suffer drop and neither receive impact.
- With the side of the arrow upward.
- With humidity protection, not to expose to rains, sparkling of water or humidified floor.
- With temperatures from -12ºC to 50ºC.
- With maximum piling up of 13 units for storage.
Content of accessible and non-accessible demarcations
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TECHNICAL SPECIFICATIONS
Packing symbols
Packing to be stored with a maximum stack of 13 units.
Packing to be transported and / or stored avoiding humidity, rains and wet floor.
The packing must be stored and trans­ported away from direct sun light exposure.
Product symbols
B type equipment
Warning - Consult the manual
Packing to be transported and / or stored with the harrows up.
Packing to be transported and / or stored with care (should not suffer drop and neither receive impact).
Temperature limit for the packing to be stored or transported.
Landing (in many parts of the equipment) indicates the condition of being landed.
On/Off timer button
Time selection
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TECHNICAL SPECIFICATIONS
Dimensions (mm)
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OPERATION
05
01
06
09
08
10
• For your safety the Optilight LD Max is equipped with an automatic bi-voltage power supply of
90V~-240V~ - 50/60Hz.
• Plug in the power supply (01) to the electrical outlet.
• Select application time, press time selection button (10), which values are: 10s (standard mode),
20s, 60s, 80s and 90s.
• To initiate a polymerization cycle, press the timer trigger (09), which generates a short beep every
10 seconds and a 4 beeps at the end of the cycle.
• To interrupt a polymerization cycle just activate the timer trigger again (09).
IMPORTANT:
• Keep the light conductor tip (06) at least 2mm away from the restoration.
• Keep the light conductor (06) always protected by an expendable PVC film, which must be changed for every patient. This procedure protects the light conductor from scratches and other residues.
• Use the polymerization time recommended by the compound resin manufacturer and always perform restorations in incremental layers with a maximum thickness of 2mm.
Instructions for equipment operation
WARNING
• Never aim the blue light beam towards the eyes
• Use the eyesight protection (05)
In order to protect the eyes, the eyesight protection (05) filters only the blue light used for the resins
polimerization, and it allows ambient light to pass through.
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MAINTENANCE
Recommendations for the dental equipment maintenance.
Your Gnatus equipment has been designed and developed according to the standards of modern techology. Similarly to other kinds of equipment, it requires special care, which is many times neglected due to several reasons and circunstances.
Therefore, here are some important reminders for your daily routine. Try to follow these simple rules, which will save you a lot of time and will avoid unnecessary expenses once they start making part of your working procedure.
Precautions
- Install your equipment in an appropriate place away from sunlight exposure and humidity.
- The equipment and the light conductor cannot be placed in the oven or autoclaves.
- The conductor can’t be immersed in solvents or substances that contain acetone in its composition.
- Avoid the light conductor to terminal to touch the resin to be polymerized.
- When using the Optilight LD Max check if the light conductor output doesn’t have residues that
might obstruct the light beam.
INTERCHANGEABLE AND/OR REMOVABLE PARTS REPLACEMENT
If stains, fissures or scratchs where detected in the eyesight protection or in the light conductor, replace damaged components.
Cleaning conductor
The light conductor cleaning and the optical protector must be done using only neutral soap and cotton. To the exterior of the pen use neutral soap or alcohol 70% vol.
Never use any other chemical based product than previous mentioned, because along the time these products attack the surface of the instrument.
Never immerse the instrument in disinfection baths.
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Cleaning the equipment
To clean the equipment, we recommend the use of “BactSpray (Reg nº MS:
3.2079.0041.001-5) or any other similar product:
Active component: Benzalkonium chloride (tri-quaternary ammonium)
Solution 50%................................................. 0.329%
Chemical composition: Butyl Glycol, Decyl polyglucose, Sodium Benzoate, Sodium Nitrate, Essence, Deodorized Propane / Butane, demineralized Water.
For more information concerning cleaning procedures, see manufacturer’s instructions.
WARNING:
• In order to prevent risks and damages to equipment, make sure that the liquid does
not enter into the unit.
• The application of other solvent-based cleaning products or sodium hypochloride
isn’t recommended, because they may damage the equipment.
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TROUBLESHOOTING
Problem: Probable Cause: Solution:
Imprevisto
- Equipment is not working. - Power source is disconnected.
- Power cut.
- Equipment is not polymerizing resins.
ATTENTION:
Any other problem that could happen with its equipment, should only be repaired by an authorized technician Gnatus.
The bad use, negligence or maintenance not made by technician authorized by the maker, will imply in the loss of the warranty.
- Resin is not suitable for photo polymerizator wave length.
- To connect the alimentação source.
- Check the energy supply.
- Provide proper resin for the photo polymerizator wave lenght, the ones which contains photo initiators with alcanphor quinone.
FINAL CONSIDERATIONS
The most important aspect related to equipment care is that concerning spare parts.
To guarantee the life span of your equipment, use only original Gnatus spare parts. They are sure to follow the technical specifications and standards required by Gnatus.
We must also point out to you our chain of authorized dealers. Only dealers that make part of this chain will be able to keep your equipment constantly new for they count on technical assistants who have been trained and on spedific tools for the correct maintenance of your equipment.
Doubts and information: GNATUS Call center (55-16) 2102-5000.
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