SAEVO Light Curing Unit Optilight Max Owner’s Manual

OWNER’S MANUAL Curing
Light Optilight Max

PRESENTATION OF MANUAL

INSTRUCTIONS FOR USE
Technical Name: Equipment for dental bleaching and photopolymerization of resins
Trade Name: Curing Light Optilight
Model: Max
Brand: Saevo
Manufacturer/Distribuitor:
Alliage S/A Indústrias Médico Odontológica
Rodovia Abrão Assed, Km 53 + 450m – CEP 14097-500
Ribeirão Preto – SP – Brasil
Tel: +55 (16) 3512-1212
Technical Duties: Daniel R. de Camargo
CREA-SP: 5062199650
Registration ANVISA #: 10069210081
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.

IDENTIFICATION OF EQUIPMENT

Dear Customer
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.

IDENTIFICATION

Technical Name: Equipment for dental bleaching and photopolymerization of resins
Trade Name: Curing Light Optilight
Model: Max

IDENTIFICATION OF EQUIPMENT
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.
Physical Principle used by the 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 500nm (blue light), which has an ideal intensity for being integrated with the canforoquinone.
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.
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 infinitely 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 efficiency 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 – 500nm 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 specifications 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).
It has 3 application modes: Continuous, Ramp and Pulsating:

• Continuous: Maximum and continuous mode of light intensity (same luminosity from start to finish of the polymerization).
• Ramp: Gradual mode of light intensity; it increases gradually.
• Pulsed: Pulsing mode consisting of cycles which oscillate at a fixed frequency.

IDENTIFICATION OF EQUIPMENT

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 filter.
• 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 fiber optics, rotating, removable and easy to sterilize, with a   front protector of thetip 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.

MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

1.  Light Conductor
2. Light Protection Shield
3.  Control Panel
4.  Handpiece
5. Button to turn on the equipment and activate / interrupt operation
6. Charging base
7. Display Window
8. Time adjustment button
9. Application mode selection button
10. Power supply source
11. Application mode: Continuous, Ramp and Pulsed

Accessories which come with the product:

The content of this page is for informative purpose, so the equipment can present itself different from the illustration. Therefore, when buying the product, verify the technical compatibility between the equipment, coupling and accessories.
The use of any part, accessory or material neither specified nor foreseen in those use operation instructions and it is of the user’s entire responsibility.

TECHNICAL SPECIFICATIONS

General features

Power Supply| Ve: 100 – 240V~ – 50/60Hz
Vs: 5V – 1,5 A
---|---
Frequency| 50/60Hz
Source Power| 6VA
Light Source| 1 LED
Light Power| Light power: 1200 mW/cm
± 200 mW/cm
Semi-conductor LED (InGaN)
Wavelength| 420nm – 500nm
Timer| 5,10,15 and 20 seconds
Time Sounder| a “beep” every 05 seconds
Activation| Through the handpiece button
Light Conductor| Optics fiber 100% coherent which guarantees the passage of light without loss
Handpiece body| Injected in ABS
Net weight| 0,39 kg
Gross weight| 0,98 kg
Classification of the Product| As per standard NBR IEC 60601-1
Type of protection against electric shocks| Class II Equipment
Applied part| Type B
Degree of protection against harmful penetration of water| IP00
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 for recharging battery| 3h

Electromagnetic emission

1. This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
2.  Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation.
4.   Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Electromagnetic emission

The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should assure that it is used in such an environment.

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emission CISPR 11| Class A
Harmonic emissions IEC 61000-3-2| Class A| The device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions IEC 61000-3-3| Complies

Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Electrostatic discharge (ESO)
IEC 61000-4-2| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air| ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air| Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input/ output lines| ±2 kV for power supply lines
±1 kV for input/ output lines| Mains power quality
should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5| ±1 kV line(s) to line(s)
± 2 kV line(s) to earth| ±1 kV line(s) to line(s)
± 2 kV line(s) to earth| Mains power quality
should be that of a typical commercial or hospital environment.
Voltage ips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| 0% UT; 0.5 cycle at 0°,45°,90°, 135°,
180°, 225°, 270°, 315° 0% UT; 1 cycle
70% UT; 25/30 cycle 0% UT; 250/300 cycle| 0% UT; 0.5 cycle at 0°,45°,90°, 135°,
180°, 225°, 270°, 315° 0% UT ; 1 cycle
70% UT; 25/30 cycle 0% UT; 250/300 cycle| Mains power quality
should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50Hz/60 H z) magnetic field IEC 61000-4-8| 30 A/m 50/60Hz| 30 A/m 50/60Hz| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE Ut is the a.c. mains voltage prior to application of the test level

Guidance and manufacture’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---
Conducted RF IEC 61000-4-6| 3 Vrms 150 kHz to 80 MHz
3 V RMS outside the ISM band, 6 V RMS in the ISM bands| 3 V RMS outside the ISM band, 6 V RMS in
3 Vrms 150 kHz to 80 MHz 3 V RMS outside the ISM band, 6 V RMS in the ISM bands| Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d=0.35√p d=1.2√p
Radiated RF IEC 61000-4-3| 3 V/m 80 MHz to 2.7 GHz 80% AM at 1kHz| 3 V/m 80 MHz to 2.7 GHz
80% AM at 1kHz| 80MHz to 800MHz： d=1.2√p
800MHzto 2.7GHz： d=2.3√p
Where, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance.
Field strengths from fixed RF transmitters, as determined by an lectromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a – Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b – Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the device
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter (W)| Separation distance according to frequency of transmitter (m)
---|---
150 kHz to 80 MHz d= 1,24p| 80 MHz to 800 MHz d= 1,2Vp| 800 MHz to 2.7 GHz d= 2,3V p
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1 , 2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Test frequency (MHz)| Band 4 (MHz)| Service”| Modulation b)| Maximum power (W)| Distance (m)| Immunity teste level (V/m)
---|---|---|---|---|---|---
385| 380 – 390| TETRA 400| Pulse modulation b) 18 Hz| 2.| 0,3| 27
450| 430 – 470| GMRS 460, FRS 460| FM 0 ± 5 kHz deviation 1 kHz sine| 2| 0,3| 28
710| | LTE Band 13, 17| Pulse modulation b) 217 Hz| 0,2| 0,3| 9
745| 704 – 787
780
810| | GSM 800/900 TETRA 800, MEN 820, COMA 850, LTE Band 5| Pulse modulation b) 18 Hz| 2| 0,3| 28
870| 800 – 960
930|
1720| 1 700 – 1 990| GSM 1800; CDMA 1900; GSM 1900;
DECT; LTE Band 1, 3, 4, 25; UMTS| Pulse modulation b) 217 Hz| 2| 0,3| 28
1845
1970
2450| 2 400 –
2 570| Btuetooth. WLAN, 802.11 b/g/n. RFIO 2450, LTE Band 7| Pulse modulation b) 217 Hz| 2| 0,3| 28
5240| 5 100 –
5 800| WLAN 802. 11 a/n| Pulse modulation b) 217 Hz| 0,2| 0,3| 9
5500
5785|

Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device, should assure that it is used in such an environment.

NOTE if necessary to achieve the immunity test level, the distance between the transmitting antenna and the me equipment or me system may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance. Minimum separation
distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
Dimensions (mm)

Packing symbols

| Stacking Limit by number
---|---
| This side Up
| Fragile, handle with care
| Keep dry
| Keep away from sunlight
| Temperature limitation

Product symbols

| Type B
---|---
| Attention
| Refer to the instruction manual
| Serial number
| Manufacturing date
| Model
| General warning
| Recyclable
| Grounding (at several points of the equipment) indicates the condition of being grounded
| Model Number
****| Manufacturer

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 assembledequipment in the charging base.

Charge the battery during 08 hours before using the equipment for the first time.

OPERATION OF EQUIPMENT

• 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 finish of the polymerization).
  – Ramp: Gradual mode of light intensity; it increases gradually.
  – Pulsed: Pulsing mode consisting of cycles which oscillate at a fixed 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’smouth 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.

OPERATION OF EQUIPMENT
ATTENTION:

•  Recharge the battery when one of the LED continuous, ramp and pulsed are blinking;
• Keep the handpiece in the charging base (connected to the mains power) 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

|

• Continuous:  Maximum and continuous mode of light intensity  (same luminosity from start to finish of the polymerization).

• Maximum power = 1200 mW/cm²*

---|---
| • Ramp: Gradual mode of light intensity, it increasesgradually.
• Gradual increase = 500 – 1200 mW/cm²
| • Pulsed: Pulsing mode consisting of cycles which oscillate at a fixed frequency.
• On/off every 1sec. maximum power = 1200 mW/cm²

• Tolerance is ± 200 mW/cm²

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.
WARNING:

• Never point the blue beam of light at anybody’s eyes;
• Protect the visual field using the Light Protection Shield;
• The Light Protection Shield aims to filter 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 field.
• After use always maintain the light conductor protected by the protection cover.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

Recommendations for the equipment’s conservation
Your equipment has been designed and improved following modern technology standards. All devices need special care, which a lot of times are forgotten for several reasons and circumstances, because of that, here are some important reminders for your everyday. Seek to observe these little rules that incorporated to the job’s routine, will provide a big time economy and will avoid unnecessary expenses.

Transport conditions, warehousing 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 floor;
• 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 specified in the packaging;

Environmental condition for transportation or storage:

• Room temperature range for transportation or storage -10ºC to +55ºC.
•  Relative humidity range for transportation or storage ≤93%.
•  Atmospheric pressure range 50 – 106KPa.

Environmental operation condition:

• Room temperature range for functioning +10ºC to +40ºC.
• Relative humidity range for functioning 10% to 80%.
• Atmospheric pressure range 70 – 106KPa.

Attention
The Equipment maintains its condition of safety and efficacy, provided that it is maintained (stored) as mentioned in this instruction of use. Thus, the equipment will not lose or alter its physical and dimensional features.
Sensitivity to predictable environmental conditions in ordinary situations of use

• The equipment has been designed not to be sensible to interferences as magnetic fields, external electrical influences, electrostatic discharges, the pressure or the variation of pressure, since the equipment is installed and kept clean, conserved, transported and operated conforming this operation instruction.

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 inflammable with air, or oxygen and nitrous oxide can be detected.
• Before the first 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 Alliage 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. Manufacturer 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 the equipment off while in not in use for a long time.

• Carry out the cleaning and disinfection after the use of the equipment, including in the first use.

• Do not change any part of the equipment. Do not disconnect the cable or other connections unnecessarily.

• When observing the presence of irremovable stains, cracks or fissures on the light conductor and ocular protection, provides the replacement of the damaged components.
  Precautions and warnings during “cleaning and disinfection” of the equipment

• When disinfecting the handpiece, remove the light conductor; use neutral soap or alcohol 70% vol. Never use povidone iodine, glutaraldehyde or chlorinated products, which with time can produce superficial attacks over the instrument’s body. Never soak the instrument in disinfection baths.

• The conductor must be clean and sterilized at 134ºC before being used in the next patient.

• Before cleaning the equipment, disconnect it from the electricity.

• Avoid spilling water or other liquids inside the equipment, what might cause short circuits.

• Do not use micro-abrasive material or scouring pad in cleaning, do not use organic solvents or detergents that can contain solvents like ether, stain remover, 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 (Alliage).

Precautions for the Reduction of the Environment Impact
Alliage S/A aims to achieve an environmental policy that encourages the environmentally conscious supply of medical products that continuously minimize environmental impact and are more environmentally friendly and human health friendly.
To keep a minimum impact on the environment, observe the following recommendations:

• After installation, forward the recyclable materials for the recycling process.
• During the life circle of the equipment, turn it off when it is not being used. The biomedical waste comprises nonhigh material susceptible to cause disease or house pathogenic organisms that must be stored in a yellow bag properly labeled with the symbol of biological hazard, or stored in a container resistant to perforation, tight and even collection and incineration.

**** The packaging consists of cardboard, plastic and expanded polystyrene (EPS) which are 100% recyclable materials.

Dimensions:
Main unit: 0,250 X 0,190 X 0,070 / MASS: About: 0,825 Kg.
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.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Cleaning ,Disinfection and Sterilization
Attention
Cleaning, disinfection, and sterilization have limited impact on the reusable parts of the equipment. Therefore, the number of repeated procedures should not exceed 20 times.
Preparation for use
Immediately after use, the reprocessing equipment is immersed in <40 °C tap water (drinking water quality, ‘water’ mentioned in this chapter, which is required to meet this standard) to remove dirt. Do not use a fixed detergent or warm water (>40 ° C) as this will cause the residue to be fixed and affect the effect of repeated treatment.
Transport: Transport to the post-processing area for safe storage to avoid any damage and environmental pollution.
Preparation before cleaning
Remove the body light guide from the main unit and place it in a stainless steel box.
Decontamination preparation (pre-cleaning):
Rinse the body light guide with running tap water (<40 °C) until all visible residue is removed.
Manual cleaning
Rinse the body light guide with running tap water (<40 ° C) and gently wipe the visible dirt with a soft brush; Place the body light guide in a multi- enzyme cleaner and soak for 10 minutes to decompose the contaminants. Follow the instructions of the cleaning agent manufacturer;
The body light guide was placed under running tap water for at least 1 minute to remove the residue of the cleaning agent.
Attention
We recommend the use of proven Lilcon® multi-enzyme cleaning solutions or multi-enzyme cleaning solutions that comply with local regulations (eg CE, FDA approval).
Manual disinfection
Place the body light guide in a dish containing the cleaning and disinfecting solution for 10 minutes for immersion disinfection.
The body light guide was rinsed with running tap water (<40 ° C) for at least 1 min to remove residuals from the disinfectant.
Disinfectant: It is recommended to use Ronso O-Benzaldehyde Disinfectant (OPA), no need to match.
Attention

1. If other disinfectant is used, use a disinfectant that complies with local national regulations (such as CE certification, FDA certification), and follow the instructions provided by the manufacturer of the disinfectant.
2. In order to prevent the disinfectant from corroding the device, the time of immersion disinfection should not be too long (<30min).

Dry
Dry the fiber rod with a lint-free cotton cloth.
Inspection and maintenance
After cleaning and disinfecting, the body light guide is visually inspected for cleanliness. No visible contaminants are considered to be clean. If the body light guide is found to be corroded and rusted, stop using it immediately.
package
Immediately after drying, place the body light guide in a steam sterilization bag for sealed packaging.
Attention
Steam sterilization bags in accordance with ISO 11607-1 should be used and the packaging must be sealed with a sealing machine.
Sterilization
Use a high pressure steam sterilizer in accordance with EN 13060 for sterilization.
Sterilization in an autoclave according to ISO 17665-1.

1. sterilizable parts: body light guide;
2. Sterilization method: high pressure steam sterilization method;
3. Sterilization conditions: at 134 ° C, not less than 18 min.

Attention
The body light guide can be autoclaved, and no other parts are available.
Storage
Store the sterilization equipment in a dry, clean, dust-free environment at a suitable temperature of 10°C to 40°C.

Preventive Maintenance
The equipment must suffer routinely measurements, following the current legislation of the country.
But, never with a period superior to 3 years.
For protecting your equipment, look for a Alliage technical assistance for periodic reviews as preventive maintenances.
Corrective Maintenance
The supplying of the circuits’ diagram, Part lists or any other information that permits the technical assistance by the user, can be requested, since previously agreed between the buyer and Alliage.
Attention
In case of the equipment presents any abnormality; check if the problem is related to some of the listed items under the item Unpredictable (situation, cause and solution).
If it’s not possible to solve the problem, shutdown the equipment and demand the presence of a Alliage’ technician from the nearest resale, or ask through the Attendance Service
Alliage: + 55 (16) 3512-1212.

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.

– Overheating protection activated “error code: oU. – LED damaged “error code: Er.| – Recharge the handpiece on the base for 3 hours.
– Wait a few minutes.
– Get in touch with the Alliage technical assistance.
– The equipment is not polymerizing the resins.| – 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.| – 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.
– Inadequate luminous power.| – Light conductor fastened incorrectly.
– Problems with the light conductor.
– Reduced capacity of the batterq.| – Fasten the light conductor correctly.
– Replace the light conductor.
– Get in touch with the Alliage technical assistance.

EQUIPMENT’S WARRANTY
This equipment is covered by the warranty periods, terms and conditions contained in the Warranty Certificate that comes with the product.
FINAL CONSIDERATIONS
Among the care you have to take with your equipment, the most important is regarding of the spare parts replacement.
To ensure the lifetime of your device, only replace original spare parts from Alliage. They have the assurance of the standards and technical specifications required by the Alliage representative.
We call your attention to our authorized resellers’ chain. Only this chain will keep your equipment constantly new, because it has trained technical assistant and specific tools for the correct maintenance of your device.
Whenever you need, demand the presence of a Alliage’ technician from the nearest resale, or ask through the Attendance Service Alliage: + 55 (16) 3512-1212.

REGISTRATION ANVISA #:10069210081
www.saevon.com.br

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>