Gnatus Optilight Max User manual

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INDEX

PRESENTATION OF MANUAL ........................................................................ 26

IDENTIFICATION OF EQUIPMENT ................................................................. 27

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION ...... 29

TECHNICAL SPECIFICATIONS ....................................................................... 30

- Eletromagnetic emissions ............................................................................... 32

- Standards applied .........................................................................................35

- Dimensions ..................................................................................................36

- Packing symbols ............................................................................................37

- Product symbols ............................................................................................37

- Content of accessible and non-accessible demarcations ...................................... 38

INSTALLATION OF EQUIPMENT ....................................................................38

OPERATION OF EQUIPMENT .........................................................................39

PRECAUTIONS, RESTRICTIONS AND WARNINGS .......................................... 41

- Transportation, storage and operation ..............................................................41

- Sensitiveness to environmental conditions foreseeable in normal situations of use .41

- Precautions and warnings “during the installation” of equipment .......................... 42

- Recommendations for preserving the equipment. ...............................................42

- Precautions and warnings “after” the use of equipment ...................................... 43

- Precautions and warnings during the “cleaning and disinfection” of equipment ....... 43

- Precautions in case of alteration in the functioning of equipment ..........................43

- Precautions to be adopted against foreseeable or uncommon risks,

related to the deactivation and abandoning of equipment ..................................... 43

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION............ 44

- Cleaning and disinfection ................................................................................44

- Preventive maintenance ................................................................................. 45

- Corrective maintenance..................................................................................45

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS ........................................ 45

WARRANTY OF EQUIPMENT .......................................................................... 46

FINAL CONSIDERATIONS ..............................................................................47

PRESENTATION OF MANUAL

INSTRUCTIONS FOR USE

Technical Name: Equipment for dental bleaching and photopolymerization of resins.

Brand: GNATUS

Model: Optlight Max

Trade Name: Optlight

Brand: GNATUS

Manufacturer/ Distribuitor:

GNATUS - EQUIPAMENTOS MÉDICO-ODONTOLÓGICOS LTDA. Rod. Abrão Assed , Km 53+450m - Cx. Postal 782 CEP 14097-500 Ribeirão Preto - S.P. - Brasil Fone +55 (16) 2102-5000 - Fax +55 (16) 2102-5001 C.N.P.J. 48.015.119/0001-64 - Insc. Est. 582.329.957.115 www.gnatus.com.br - gnatus@gnatus.com.br Technical Duties: Gilberto Henrique Canesin Nomelini CREA-SP: 0600891412

Registration ANVISA Nº: 10229030046

ATTENTION

For greater safety:

Read and understand all the instructions contained in these

Instructions for Use before installing or operating this Equipment.

Note: These Instructions for Use must be read by all the operators

of this Equipment.

DESCRIPTION OF THE EQUIPMENT

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.

Identication

Technical Name: Equipment for dental bleaching and photopolymerization of resins. Trade Name: Optlight Max Brand: GNATUS

Principles and bases applied to the functioning of the product

It has hoses with compressed air and connectors for the supply of handpieces (high and

low rotation) and a syringe with air and water outlet.

Description of Equipment

The Optilight Max is the latest generation of the appliances of photoactivation by LED light. This short name is the acronym for Light Emitting Diode, a totally different manner of emitting light, when compared with the conventional appliances of halogen light. As opposed to the traditional appliances, which generate light in a wide wave spectrum with great heat, this technology allows a cold light to be emitted, in the precise wavelength for activating the different dental products to which it applies.

LED technology, recently introduced in Dentistry, has brought countless advantages to the curing light appliances for direct restorations in composite resin. Besides being

innitely more durable, the LEDs have made the appliances more compact, ergonomic and

easy to install and transport. The emission of cold light at a precise wavelength ensures the polymerization of composites activated by the canforoquinone, without risks of dental heating, pulpal injury or discomfort for operator and patients.

The safety and efciency of the LEDs, now with high emission power, are available for

all the clinical procedures which require power of light for photoactivation.

The wavelength of 420nm - 480nm associated with the high power emitted by the Optilight Max makes the multifunctionality of this appliance feasible:

• Direct restoring procedures: composite resins, ionomers and adhesives.

• Indirect restorations: adhesive cementing of laminates, inlays, esthetic pegs and

metal-free crowns.

• Activation of photoactivated materials as sealers, surgical cements and lining

bases.

Planned and built using cutting-edge technology, to provide results within the specications

stipulated by the leading world dental authorities.

Endowed with an automatic bivolt switch power supply which allows one to use the equipment at any power supply voltage between 100 and 240V~ - 50/60Hz.

Digital control in the display on the handpiece itself.

Variance of choice of operating time (5,10,15 and 20 seconds).

DESCRIPTION OF THE EQUIPMENT

It has 3 application modes: Continuous, Ramp and Pulsating:

• Continuous: Maximum and continuous mode of light intensity (same luminosity from

start to nish of the polymerization).

• Ramp: Gradual mode of light intensity; it increases gradually.

• Pulsed: Pulsing mode consisting of cycles which oscillate at a xed frequency.

Advantages offered by Optilight 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 lter.

• It does not require forced ventilation, thus avoiding noise emission. * We noted that the light emitted by the Optilight 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 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.

Light conductor with ber optics, rotating, removable and easy to sterilize, with a front

protector of the tip against scratches and the accumulation of undesirable residue. The reduced weight of the penand its anatomic design ensure that the professional’s work is more comfortable and practical.

Support for the handpiece, which ensures easy access and handling.

Physical Principle used by the Optilight Max equipment

The physical principle is the emission of a cold light to polymerize photosensitive substances, as the equipment is endowed with a cold light emitter (LED) with a wavelength between 420 and 480nm (blue light), which has an ideal intensity for being integrated with the canforoquinone.

Indication of the equipment

This equipment is exclusively for dental use, having to be employed and handled by a capacitated person (professional duly regulated, as per the local legislation of the country) observing the instructions contained in this manual.

The user is obliged to only use the equipment in perfect conditions and protect himself/ herself, patients and third parties against possible hazards.

Purpose of the equipment

This equipment is exclusively for dental use, with the objective of polymerizing photosensitive substances through the emission of blue light.

It was developed to be used in several dental procedures such as: restoring procedures, bonding braces and activating photoactivated materials as sealers, lining bases.

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

Optilight Max

01 – Light Conductor 02 – Light Protection Shield 03 – Control Panel 04 - Handpiece 05 – Button to turn on the equipment and activate / interrupt operation 06 – Charging base 07 – Display Window 08 – Time adjustment button 09 – Application mode selection button 10 – Power supply source 11 – Application mode: Continuous, Ramp and Pulsed

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

Accessories which come with the product:

Handpiece

Light Protection

Shield

Light Conductor Power supply source

TECHNICAL SPECIFICATIONS

Power Supply

Ve: 100 - 240V~ - 50/60Hz Vs: 5V - 1,5 A

Frequency

50/60Hz

Source Power

8VA

Light Source

1 LED

Light Power

1200 mW/cm Semicondutor LED (InGaN)

Wavelength

420nm - 480nm

Timer

5,10,15 and 20 seconds

Time Sounder

a “beep” every 05 seconds

Activation

Through the handpiece button

± 200 mW/cm

Charging base

TECHNICAL SPECIFICATIONS

Light Conductor

Optics ber 100% coherent which guarantees the passage of light without loss.

Handpiece body

Injected in ABS

Net we ight

0,39 kg

Gross weight

0,98 kg

Classication of the Product:

As per standard NBR IEC 60601-1

Type of protection against electric shocks

Class II Equipment

Degree of protection against electric shocks

Applied part of Type B

Degree of protection against harmful penetration of water

IPX 0

Degree of saf ety of application in the presence of an anesthetic mixture inf lammable with air, oxygen or nitrous oxide

It is not suitable

Battery of Li-ion

DC 3,7V 2200mAh

Approximate time f or recharging battery

TECHNICAL SPECIFICATIONS

Eletromagnetic emissions

TECHNICAL SPECIFICATIONS

Standards applied

This product was tested and approved as per the standards:

NBR 60601-1:1997 - Equipamento Eletromédico- Parte 1: Prescrições gerais para

segurança;

NBR ISO 14971:2009- Produtos para a saúde - Aplicação de gerenciamento de risco a

produtos para a saúde;

EN ISO 13485-2003 - Quality Systems - Medical Devices; IEC 60601-1-2:2007 - Collateral Standard - Eletromagnetic Compatibility. EN ISO 9001:2008 - Quality Management System - Requirements RDC 59/2000 - Boas práticas de fabricação de produtos médicos - ANVISA

TECHNICAL SPECIFICATIONS

Dimensions (mm)

Optilight Max

TECHNICAL SPECIFICATIONS

Packing symbols

Maximum stacking: It determines the maximum quantity of boxes which can be stacked during transportation and storage “as per packaging”.

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).

Product symbols

Note: It indicates useful information for operation of the product.

Important: It indicates an instruction of safety for operation of the product. Not following it, can lead to serious danger to the patient.

Packing to be transported and / or stored avoiding humidity,

rains and wet oor.

The packing must be stored and transported away from direct sun light exposure.

Temperature limit for the packing to be stored or transported.

Landing (in many parts of the equipment) indicates the condition of being landed.

B type equipment

Authorized representative in the European Community

Warning - Consult the manual

TECHNICAL SPECIFICATIONS

Content of accessible and non-accessible demarcations

RESPONSÁVEL TÉCNICO:

Gilberto Henrique Canesin Nomelini

CREA-SP: 0600891412

INSTALLATION OF THE EQUIPMENT

• For your safety the Optilight Max has an

automatic bivolt power supply source of

100V~ - 240V~ - 50/60Hz.

• Connect the cable of the power supply

source (12) to the charging base (06) and the power supply source (10) in the socket.

• Insert the light conductor (01) in the

handpiece (04).

• Remove the protection cover (13) from

the light conductor.

• Insert the light protection shield (02) in

the light conductor and place the assembled equipment in the charging base.

Charge the battery during

08 hours before using the

equipment for the rst time.

OPERATION OF EQUIPMENT

Hand piece

CORRECT

positioning for

battery charging.

• Press the button (05) to turn on the equipment.

• Select the application mode pressing the selection button (09), of which the variations are:

- Continuous: Maximum and continuous mode of light intensity (same luminosity from

start to nish of

the polymerization).

- Ramp: Gradual mode of light intensity; it increases gradually.

- Pulsed: Pulsing mode consisting of cycles which oscillate at a xed frequency.

The application mode chosen will be viewed in the sequence of LEDs (15).

• In order to schedule the time press the button (08) and choose the time 5 thru 20

seconds, which will be viewed in the display (07).

• After selecting the mode of application and the choice of time, take the handpiece to

the patient’s mouth and position the light guide at a safe distance.

• In order to start the polymerization cycle, press the start button (05). To interrupt it

Just activate it again.

Hand piece

INCORRECT

positioning for

battery charging.

OPERATION OF EQUIPMENT

ATTENTION:

- Recharge the battery when one of the LED continuous, ramp and pulsed are blinking;

when not using;

- When the LED of the charging base (14) is indicating red, the battery is being charged;

- The approximate recharging time is 3 hours. After recharging the LED in the charging base (14) it will change to green, indicating the complete recharging;

- The battery does not have a memory effect and can be recharged even if it is not completely discharged.

Application types: Continuous, Ramp and Pulsed

- Keep the handpiece in the charging base (connected to the mains power)

• Continuous:

Maximum and continuous mode of light

intensity (same luminosity from start to

nish of the polymerization).

• Maximum power = 1200 mW/cm²*

• Ramp:

Gradual mode of light intensity, it increases gradually.

* Tolerance is ± 200 mW/cm²

• Gradual increase = 500 - 1200 mW/cm²*

• Pulsed:

Pulsing mode consisting of cycles which

oscillate at a xed frequency.

• On/off every 1sec. maximum power =

1200 mW/cm²*

OPERATION OF EQUIPMENT

Automatic disconnection: The equipment will be turned off automatically to save

energy. Thus, if the appliance is not on the charging base and the user doesnot use it within 3 minutes, the appliance turns off automatically. In order to turn it on again, press the on/off button (05).

Instructions for the Use of the Equipment.

• Never point the blue beam of light at anybody’s eyes;

• Protect the visual eld using the Light Protection Shield (02)*;

• The Light Protection Shield (02) aims to lter only the blue light which acts in the

photopolymerization of resins to protect one’s vision and also allows the ambient illumination

to go to the operating eld.

• After use always maintain the light conductor (01) protected by the protection cover.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Transportation, storage and operation

This equipment must be transported and stored observing the following directions:

- Avoid falls and impacts;

- Keep it dry, do not expose it to rain, water drops or wet oor;

- Keep it away from water and direct sunlight, and in it original wrapping;

- Don’t move it over irregular surfaces, protect it from rain and observe the maximum

stack quantity specied in the packaging;

- Transportation and storage temperature range: -12°C to 50°C.

- Ambient temperature range recommended by Gnatus +10 ° C to +35 ° C.

The Equipment maintains its condition of safety and efcacy, provided that it is

kept (stored) as mentioned in this instruction for use. Thus, the equipment will not lose or alter its physical and dimensional features.

Sensitivity to environmental conditions in normal situations of use

- The equipment has been planned not to be sensitive to interference such as magnetic

elds, external electrical factors, electrostatic discharge, pressure or variance of pressure,

provided that the equipment is installed, maintained, clean, preserved, transported and operated as per this instruction for use.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

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 and warnings “during the installation” of the equipment

- Check the voltage of the equipment upon executing the electrical installation.

- Position the equipment in a place where it will not get wet.

- Install the equipment in a place where it will not be damaged by the pressure,

temperature, humidity, direct sunlight, dust, salts, or sulfur compounds.

- The equipment must not undergo inclination, excessive vibrations, or blows (including

during transportation and handling).

- This equipment was not planned for use in an environment where vapors, anesthetic

mixtures inammable with air, or oxygen and nitrous oxide can be detected.

- Before the rst use and/or after long interruptions from work such as vacations, clean

and disinfect the equipment.

- This equipment is not sensitive to electrical, electrostatic and pressure interference, provided that the items of cleaning, maintenance, transportation and operation of this Manual are observed.

However, an electromagnetic environment can interfere with its normal operation.

Precautions and warnings “during the use” of equipment

- The equipment should only be operated by duly enabled and trained technicians (Dental

Surgeons, Capacitated Professionals)

- If any maintenance should be required, only use services of the Gnatus Authorized

Technical Assistance.

- Do not expose the plastic parts to contact with chemical substances, use in the routines

of dental treatment, such as: acids, mercury, acrylic liquids, amalgams, etc.

- Avoid the light conductor to terminal to touch the resin to be polymerized.

- When using the equipment check if the light conductor output doesn’t have residues

that might obstruct the light beam.

- Use suitable techniques to minimize the effects of the contracting of the photopolymerized material and also of the temperature in the region applied. These techniques consist of spacing proportional to the effect desired, i.e., withdrawing the tip from the activated region the power and temperature tend to diminish.

- A minimum distance of 10mm between the tip and the tooth is advisable.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Gnatus shall not be responsible for:

- Use of the equipment differing from that for which it is intended.

- Damages caused to the equipment, the professional and/or the patient by the incorrect installation and erroneous procedures of maintenance, differing from those described in these Instructions for use which come with the equipment or by the incorrect operation of it.

Precautions and warnings “after” the use of equipment

- Turn off the main switch of the dental set when it is not in use for an extended period

of time.

- Always maintain the equipment clean for the next operation.

- Do not modify any part of the equipment. Do not disconnect the cable or other

connections without need.

- After using the equipment, clean and disinfect all the parts which may be in contact

with the patient.

- Upon noticing irremovable stains, splits or cracks in the light conductor or in the eye

protector, replace the damaged components.

Precautions and warnings during the “cleaning and disinfection” of the equipment

- Upon disinfecting the handpiece remove the light conductor, use neutral soap or alcohol 70% vol. Never use iodopovidone, glutaraldehydes, or chlorinated products, as over time, they attack the surface of the body of the instrument. Never submerge the instrument in disinfecting baths.

- The conductor should be cleaned and sterilized at 134ºC, before being used on the next patient.

- Before cleaning the equipment, disconnect it from the electrical network.

- Avoid spilling water, even by accident, or other liquids inside the equipment, as it could cause short-circuits.

- Do not use microabrasive material or steel wool in the cleaning, and do not employ organic solvents or detergents which contain solvents such as ether, stain remover, gasoline, etc.

Precautions in case of alteration in the functioning of equipment

- If the equipment has any abnormality, check if the problem is related to any item listed in the topic of unforeseen events (failures, causes and solutions). If it is not possible to resolve the problem, turn off the equipment, remove the power supply cable from the socket and contact your representative (Gnatus).

Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation and abandoning of equipment

In order to avoid environmental contamination or undue use of the Equipment after it has become useless, it should be discarded in the suitable place (as per the local legislation of the country).

- Pay attention to the local legislation of the country for the conditions of installation

and disposal of residue.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Additional procedures for reuse

The equipment can be reused in undetermined, i.e. unlimited, quantities, only needing to be cleaned and disinfected.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Cleaning and disinfection

Important: Before cleaning or repairing this equipment be sure it is disconnected from

mains power.

The cleaning procedure below should be executed at the start of the working day and after each patient. Always turn off the main switch before executing the procedures of daily maintenance.

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.

Note: Use gloves and other systems of protection, during the disinfection.

Disinfection and sterilization

- Use clean and soft cloth dampened in alcohol 70% to disinfection of the equipment.

- Never use corrosive disinfectants or solvents. The light conductor should only be sterilized in the following conditions:

- Maximum temperature of 134ºC.

- The light conductor should be duly clean when it is packaged.

- Do not sterilize the light conductor in contact with other types of material.

Attention: Do not use any disinfectant spray, as the vapor

may be inammable, or it may

cause injury.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Preventive Maintenance

The equipment should be calibrated routinely, as per the legislation in force in the country.

But never with a period exceeding 3 years.

In order to protect your equipment, seek Gnatus technical assistance for periodic revisions

of preventive maintenance.

Corrective Maintenance

If the equipment has any abnormality, check if the problem is related to any of the items

listed in the item Unforeseen Events (situation, cause and solution).

If it is not possible to solve the problem, turn off the equipment, and request Gnatus

technical assistance.

UNFORESEEN EVENTS  SOLUTION OF PROBLEMS

Upon coming across any problem in operation, follow the instructions below to check

and repair the problem, and/or get in touch with your representative.

Imprevist Probable Cause Solution

- The Curing Light does not work.

- The equipment is not polymerizing the resins.

- Battery in the handpiece without charge.

- Overheating protection activated “error code: oU.

- LED damaged “error code: Er.

- Resin not appropriate for the wavelength range of the LED curing lights.

- Light conductor fastened incorrectly.

- Residue of resin in the light conductor.

- Light conductor with protection cover.

- Recharge the handpiece on the base for 3 hours.

- Wait a few minutes.

- Get in touch with the Gnatus technical assistance.

- Acquire the appropriate resin for the wavelength of the curing light, i.e., which contain photoinitiators with canforoquinone.

- Fasten the light conductor correctly.

- Clean the light conductor.

- Remove the protection cover from the light conductor.

UNFORESEEN EVENTS  SOLUTION OF PROBLEMS

- Fasten the light conductor correctly.

- Replace the light conductor.

- Get in touch with the Gnatus technical assistance.

- Inadequate luminous power.

- Light conductor fastened incorrectly.

- Problems with the light conductor.

- Reduced capacity of the battery.

WARRANTY OF EQUIPMENT

This equipment is covered by the warranty terms counting from the date of installation,

as specied below; provided that the defect has occurred in normal conditions of use and

that the equipment has not remained stored for more than 06 months counting from the issue date of the sales document until the date of the actual installation.

- WARRANTY TERMS: Verify the guarantee certicate;

- LOSS OF THE WARRANTY: A) Attempt to repair using an inadequate tool or by unauthorized technicians; B) Installation of the equipment by an unauthorized technician; C) Damage arising from inappropriate storage or signs of infringement; D) Incorrect use of the equipment; E) Use of a cleaning product not indicated by the factory;

F) Falls or blows which the equipment may undergo or lack of observation of an compliance with the guidelines of the Owner’s Manual, which was delivered with the present document, together with the equipment. Repair or replacement of parts during the warranty period shall not extend the validity term of their warranty.

- This warranty doe snot exempt the customer from paying the service charge for the visit and the travel expenses of the technician, except when the customer sends the equipment to execute the maintenance inside the establishment of the technical assistance.

“Consumer Defense Code - art. 50, unique paragraph”.

- The Warranty Certicate comes with the product and must be lled in upon the date

of installation by the Gnatus Authorized Technician.

- Queries and information: GNATUS Help Desk (+55) 16 2102-5000.

- Check the warranty term attached to this manual.

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 specications 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 spedic tools for the correct maintenance

of your equipment.

Doubts and information: GNATUS Call center (55-16) 2102-5000.

Gnatus Optilight Max User manual

Specifications and Main Features

Frequently Asked Questions

User Manual