SAEVO Curing Light Optilight Color Owner’s Manual
- June 12, 2024
- SAEVO
Table of Contents
Curing Light Optilight Color
Product Information
The Optilight Color Curing Light is a dental equipment used for
photo polymerizing photo sensible substances through the emission
of a blue light. It is designed for various dental procedures such
as restorative procedures, bracket bonding, and activation of
photoactivated materials like sealants and dental bases. The
equipment features a cold light emitter (LED) with a wavelength
between 420nm and 500nm (blue light), which is ideal for
integrating with camphorquinone.
Identification
- Technical Name: Equipment for resins’ photopolymerizers
- Trade Name: Curing Light Optilight Color
- Model: Optilight Color
Modules, Accessories, Options, and Materials of
Consumption
The Optilight Color Curing Light comes with the following
accessories:
-
Visor display
-
Time adjust button
-
Application mode selector button (Continuous mode, Ramp mode,
Pulse mode) -
On/Off button
-
LED indicator for battery level
-
Light conductor
-
Handpiece
-
Power supply unit
-
Base
Product Usage Instructions
Caution: To ensure safety, it is important to
read and understand all the instructions in the user manual before
installing or operating the equipment. All persons operating the
equipment must read the Instructions for Use.
Installation of Equipment
Follow the installation instructions provided in the user manual
to set up the Optilight Color Curing Light.
Operation of Equipment
To operate the equipment, follow these steps:
-
Ensure the battery is fully charged (indicated by a green LED)
or connect the power supply unit. -
Select the desired application mode (Continuous mode, Ramp
mode, or Pulse mode) using the application mode selector
button. -
Place the light conductor on the handpiece and securely attach
it. -
Press the On/Off button to activate the light.
-
Direct the emitted blue light onto the desired area for photo
polymerization.
Corrective and Preventive Maintenance and Preservation
To ensure the proper functioning and longevity of the Optilight
Color Curing Light, follow these maintenance procedures:
-
For reuse, follow additional procedures specified in the user
manual. -
Clean, disinfect, and sterilize the equipment as instructed in
the user manual. -
Perform regular preventive maintenance to keep the equipment in
optimal condition. -
If any issues arise, follow the corrective maintenance
procedures outlined in the user manual.
Equipment’s Warranty
The Optilight Color Curing Light comes with a warranty. Refer to
the warranty information provided for details.
Final Considerations
We recommend thoroughly reading and preserving this manual for
future reference and consultation.
PRESENTATION OF MANUAL INSTRUCTIONS FOR USE
Technical Name: Equipment for resins’ photopolymerizers. Trade Name: Curing
Light Optilight Color Model: Optilight Color 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 #: 10069210078
CAUTION
For improved safety: Read and understand all the instructions contained in the
Instructions for use before installation or operation of this equipment. The
Instructions for Use must be read by all persons that operate this equipment.
2
INDEX
02 PRESENTATION OF MANUAL
04 IDENTIFICATION OF EQUIPMENT
07 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
09 TECHNICAL SPECIFICATIONS 09 General features 10 Electromagnetic emission 14
Dimensions 15 Packing symbols 15 Product symbols
16 INSTALLATION OF EQUIPMENT
17 OPERATION OF EQUIPMENT
19 PRECAUTION, RESTRICTION AND WARNING 19 Recommendations for the equipment’s
conservation 19 Transport conditions, warehousing and operation 19 Sensitivity
to predictable environmental conditions in ordinary situations of use 20
Precautions and warnings “during installation” of the equipment 20 Precautions
and warnings “during the use” of the equipment 20 Precautions and warnings
“after” the use of equipment 21 Precautions and warnings during “cleaning and
disinfection” of the equipment 21 Precautions in case of alteration in the
functioning of equipment 21 Precautions for the Reduction of the Environment
Impact 21 Precautions to be adopted against foreseeable or uncommon risks,
related to the deactivation and abandoning of equipment
22 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION 22 Additional
procedures for reuse 22 Cleaning, disinfection and sterilization 23 Preventive
Maintenance 23 Corrective Maintenance
24 UNFORESEEN EVENTS SOLUTION OF PROBLEMS
25 EQUIPMENT’S WARRANTY
25 FINAL CONSIDERATIONS
3
IDENTIFICATION OF EQUIPMENT
Dear Customer
This manual offers a general presentation of your equipment. Outlines
important details that might orientate you in its correct use, as well as in
the solution of small problems that might effectively occur. We advise its
complete reading and conservation for further consults.
IDENTIFICATION
Technical Name: Equipment for resins’ photopolymerizers. Trade Name: Curing
Light Optilight Color Model: Optilight Color
4
IDENTIFICATION OF EQUIPMENT
Indication of Equipment
This equipment is for dental use only aiming to photo polymerize photo
sensible substances through
the emission of a blue light. It is used in various dental procedures such as
restorative procedures, bracket bonding and activation of photoactivated
materials such as sealants, dental bases, for exclusive dental use, and must
be used and handled by a qualified person (duly regulated professional,
according to local law of the country). following the instructions in this
manual.
Contraindications
Systemic diseases (canc er, cardiovascular diseases serious diseases, the
blood system, the immune system The disease, …). Ongoing and topical treatment
of certain systems (anticoagulant therapy, chemotherapy, radiotherapy, …). Ask
patients if they have a cardiac pacemaker or other system implanted before you
Intended use start the treatment.
Physical Principle used by the Equipment
The physical principle is the emission of a light for polymerizing photo
sensible substances, since the equipment is featured with a cold light emitter
(LED) with the wavelength comprised within 420nm a 500nm (blue light), which
has the ideal intensity for integrating with camphorquinone.
Description of the Equipment
Optilight Color is the latest generation of LED photo activation devices. This
abbreviation is the acronym for Light Emitting Diode, a totally different way
of emitting light, in comparison to the halogen conventional devices. Unlike
traditional equipments, which generate light in wide wave spectrum and a lot
of heat, this technology allows the emission of cold light in a precise
wavelength for the activation of several dental products apply. LED
technology, recently introduced in odontology, has brought several advantages
to photopolymerizers on direct restoration in composed resin. Besides
infinitely more durable, LEDs have become the most compact, ergonomic and
easy-to-install and transport equipments. The cold light emission and in
precise wavelengths assure a safe polymerization of activated composite by the
camphorquinone, without the risk of tooth warming, pulp injuries or discomfort
for both operator and patients. The safety and efficiency of the LEDs, now
with high energy emission, are available to all the clinical procedures that
require light power for photo activation. The wavelength from 420nm to 500nm
associated with the high energy emitted by Optilight Color enables the multi
functionality of this device: · Direct restoring processes: composite resins,
ionomers and adhesives. · Indirect restoring: laminated adhesive cementation,
inlays, aesthetic pins and metalfree diadems. · Activation of material photo
active as sealants, surgical cements and the basis of a foraging. Designed and
built within the most advanced technology in order to provide results within
the specifications set by the highest world odontology authorities. Equipped
with a power supply with an automatic bi-volt key that allows to use the
equipment in any supply voltage between 100 to 240V ~ – 50/60Hz. Digital
control on the display in the handpiece itself. Variation of choosing the
operation time (5,10,15 and 20 seconds). It has 3 application modes:
Continuous, Ramp and Pulse: · Continuous: Maximum mode and continuous light
intensity (same luminosity from the beginning to the end of the
polymerization). · Ramp: Gradual light intensity mode, increases gradually.
5
IDENTIFICATION OF EQUIPMENT
· Pulse: Pulse mode has cycles that oscillate at a fixed frequency. The
advantages of Optilight Color: · Light spectrally more selective than ordinary
light bulbs. · Cold light, it does not heat the resin and the tooth. · Compact
and lightweight equipment which provides a comfortable handling. · Wireless
equipment that allows free movement and overall control. · Low energy
consumption. · Higher lifetime of the light emitter element (equivalent to
36.000.000 10-second cycles). · It does not use optical filter. · It does not
require a forced ventilation system, therefore avoiding noise emission. We
observe that the light emitted by the Optilight Color is completely contained
within the absorption interval of the photo initiator and is, therefore, 100%
used while conventional devices, which use halogen lamps have a big part not
used in the process. Optilight Color does not produce heating because uses
semiconductors LEDs as light emitters. Light conductor through optic fiber,
rotatory, removable and easy to sterilize, with frontal protector against
risks and accumulation of undesirable residues. The reduced weight of the pen
and its ergonomic design ensure a more practical and comfortable work for the
practitioner.
6
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
A
Visor “display”
Time adjust button
Application mode selector button
Continuous mode Ramp mode Pulse mode
On / Off button
01
B
02
LED
Green: Full charge Red: Loading
04 03
01 – Light conductor 02 – Handpiece 03 – Power supply unit 04 – Base
A – Commands B – Indicative LED for the battery level
NOTE: Available in colors.
7
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
Accessories that come with the product:
BASE
BATTERY SENT INSIDE EQUIPMENT
OCULAR PROTECTOR
LIGHT CONDUCTOR
POWER SUPPLY UNIT
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.
8
TECHNICAL SPECIFICATIONS
General features
Voltage (Power Supply Unit) Ve: 100 – 240V~ / 50/60Hz (Bivolt) Vs: 5V – 1.5 A
Light source (1 LED) Power (Maximum): 6W Light power: 1200 mW/cm2 ± 200 mW/cm2
Semi-conductor LED (InGaN) Wavelength: 420nm – 500nm Li-ion battery DC 3.7V
2200mAh Time for full battery charge 4h (New batteries with charge time of at
least 8h) Light conductor Optic fiber 100% coherent that ensures the light
passage without losses (ø8mm 60º curve) Timer 5,10,15 and 20 seconds Time
Sounder A “beep” in every 05 seconds Triggering Through the handpiece’s button
Handpiece’s body Injected in ABS Net weight 0,389 kg Gross weight 0,640 kg
Protection against the electrical shock Class II Equipment Applicated part B
Type Protection grade against the penetration of nocive water IP00
9
TECHNICAL SPECIFICATIONS
Electromagnetic emission
Electromagnetic emission
The Optilight Color is made to be used in the electromagnetic environments specified below. The client or the user of the Optilight Color must be sure that it is used in such environment.
Emission test
Compliance
Eletromagnetic environment – Guide
RF emissions ABNT NBR IEC CISPR 11
Group 1
The Optilight Color use RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions ABNT NBR IEC CISPR 11
Emissions of harmonics IEC 61000-3-2
Class B Class A
The Optilight Color is suitable for use in all establishments, including domestic establishments and those establishments directly connected to the public lowvoltage power supply network with specific requirement.
Fluctuation of Voltage / Emissions of flicker
IEC 61000-3-3
Complies
10
TECHNICAL SPECIFICATIONS
Guidelines and manufacturer’s declaration – electromagnetic immunity
The Optilight Color is made to be used in the electromagnetic environments
specified below. The client or the user of the Optilight Color must be sure
that it is used in such environment.
Immunity test
ABNT Test level NBR IEC 60601
Level of compliance
Electromagnetic environment Directives
Electrostatic discharge (ESD) IEC 6100-4-2
± 6 kV Contact ±2 kV, ±4 kV, ±8 kV,±15 kV
±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%.
Quick electric transitory phases / train of pulses (“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.
Surges IEC 61000-4-5
±0.5 kV & ±1 kV differential mode ±0.5 kV, ±1 kV & ±
2 kV common mode
±0.5 kV & ±1 kV modo diferencial ±0.5 kV, ±1 kV & ± 2 kV modo comum
Mains power quality should be that of a typical commercial or hospital environment.
Reduction, interruption and variance of voltage in power supply input lines IEC 61000-4-11
< 100% Ut (>100% dip in Ur) for 0,5 cycle 100% Ut (100% dip in Ut) for 1 cycle 30% Ut (70% dip in Ut ) for 25/30 cycles < 100%Ut (>100% dip in Ut ) for 250/300 cycles
< 100% Ut (>100% dip in Ur) for 0,5 cycle 100% Ut (100% dip in Ut) for 1 cycle 30% Ut (70% dip in Ut ) for 25/30 cycles < 100%Ut (>100% dip in Ut ) for 250/300 cycles
Mains power quality should be that of a typical commercial or hospital environment. If the user of themodel Optilight Color requires continued operation during power mains interruptions, it is recommended that the model Optilight Color be powered from anunint erruptible power supply or a battery
Magnetic field in frequency of power supply (60Hz)
30 A/m
IEC 61000-4-8
30 A/m
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. power supply voltage before the application of the test level
11
TECHNICAL SPECIFICATIONS
Guidance and manufacture’s declaration electromagnetic immunity
The Optilight Color is intended for use in the electromagnetic environment specified below. The customer or the user of Optilight Color 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
Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM ban 3 V/m 80 MHz to 2.7 GHz
385MHz 5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1- 2:2014)
3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands
3 V / m 80 MHz to 2,7 GHz 385MHz 5785MHz Test specifications for ENCLOSURE
PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC
60601-12:2014)
Portable and mobile RF communications equipment should be used no closer to
any part of the Optilight Color, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance: d = 1,2P d = 1,2P 80 MHz to 800MHz d = 2,3P
800 MHz to 2,5MHz
whereP is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya, should be less than the compliance level in each
frequency range.b Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1 At 80MHz and 800MHz, 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 sitesurvey should be considered. If the
measured field strength in the location in which the Optilight Color is used
exceeds the applicable RF compliance level above, the Optilight Color should
be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the
Optilight Color.
b – Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
12
TECHNICAL SPECIFICATIONS
Recommended separation distances between portable and mobile RF communications equipment and the Optilight Color
The Optilight Color is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Optilight Color can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Optilight Color 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
150 kHz to 80 MHz d= 1,2p
80 Mhz to 800 MHZ d= 1,2p
80 MHz to 800 Mhz d= 2,3p
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 80MHz and 800MHz, 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.
13
TECHNICAL SPECIFICATIONS
Dimensions (mm)
14
TECHNICAL SPECIFICATIONS
Packing symbols
Stacking Limit by number
This side Up
Keep dry Keep away from sunlight
Fragile, handle with care
Product symbols
Type B Attention Refer to the instruction manual Serial number Manufacturing
date Model
15
Temperature limitation
General warning
Recyclable Grounding (at several points of the equipment) indicates the
condition of being grounded. Model Number
Manufacturer
INSTALLATION OF EQUIPMENT
1
2
3
click
1-Before using it, please, sterilize the light conductor, disinfect the handpiece, the wire and the base.
2- Insert the light conductor in the handpiece until you hear a slight click and feel that it was correctly embedded.
3-Insert the ocular protector on the light conductor.
4
5
4horas
4- Place the base on an stable site, connect the power supply unit’s cable to the handpiece and immediately connect the power supply unit to an electrical socket.
5- Let the battery charging for at least 4 hours.
Charge the battery during 08 hours before using the equipment for the first time.
16
OPERATION OF EQUIPMENT
1
Press
2
3
beep Press
beep
beep
Press
– Press the button to turn on the equipment (fig.1). – Select the application
mode pressing the selection button (fig.2), which variations are: –
Continuous: Maximum mode and continuous for light intensity (same luminosity
from the beginning
to the end of the polymerization).
– Ramp: Gradual mode, light intensity increases gradually. – Pulse: Pulse
modes are cycles that oscillate at a fixed frequency. · The chosen application
mode shall be seen in the LEDs’ sequence. · For setting time, press the button
and chose a time between a time from 5 to 20 seconds, which will be seen on
the display (fig.3).
4
10mm
– For starting the polymerization
5 cycle, press the trigger. Just
trigger again to interrupt (fig.5).
Press
-After selecting the application mode and the choice of time, remove the light conductor protection
cover and take the handpiece to the patient’s mouth and position the light
conductor at a safe distance (fig.4).
ATTENTION
Low battery:
– When the display shows the symbology
and sound
A
the beep indicating low battery, please recharge it.
– The LED charge’s indicator (A) gets red when the battery is
charging and green when the charging is complete.
– Always keep the handpiece over the base, getting energized,
when not using it;
– The approximate time for the recharge is 4 hours. After the
recharge, the LED’s charge indicator (A) will change for green,
indicating the complete recharge; – The battery does not have a memory effect and can be recharged,
even if it’s not completely discharged.
17
OPERATION OF EQUIPMENT
Automatic shutdown: The equipment will turn off automatically when not in use
for more than 3 minutes. For turning it on again, press the On / Off button.
IMPORTANT: – Never address the light beam to the eyes; – Protect the visual
field using the ocular protector; – The ocular protector has the goal of
filtrate only the blue light that operates in the photo polymerization of
resins for protecting the sight and still allows that the room light has a
path to the operative field. – After using it, keep the light conductor
protected by the protection cover.
Application types: Continuous, Ramp and Pulse
· Continuous: Maximum and continuous mode of light intensity (same luminosity
from the beginning to the end of polymerization).
· Maximum power = 1200 mW/cm²
· Ramp: Gradual mode, the light intensity increases gradually.
· Gradual increasing = 500 – 1200 mW/cm²
· Pulse: Pulse modes are cycles that oscillate at a fixed frequency.
· On/Off at each 1sec. maximum power = 1200 mW/cm²*
- Tolerance of ± 200 mW/cm²
18
PRECAUTION, RESTRICTION AND WARNING
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;
ATTENTION: The equipment must be only used with the power cable supplied by
Alliage, otherwise, it can cause the increasing of the emission or reducing of
the equipment’s immunity.
Environmental condition for transportation or storage: – Room temperature
range for transportation or storage -29ºC to +60ºC. – Relative humidity range
for transportation or storage 20% to 90%. – Atmospheric pressure range 500hPa
to 1060 hPa (375 mmHg to 795 mmHg).
Environmental condition for storage (among the operations): – Room temperature
range for storage -10ºC a +55ºC. – Recommended room temperature range +15ºC a
+30ºC. – Relative humidity range for storage 30% a 75%. – Atmospheric pressure
range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).
Environmental operation condition: – Room temperature range for functioning
+10ºC to +40ºC. – Recommended room temperature range +21ºC to +26ºC. –
Relative humidity range for functioning 30% to 75%. – Atmospheric pressure
range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg). – Operation altitude: 2000m.
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.
19
PRECAUTION, RESTRICTION AND WARNING
Precautions and warnings “during installation” of the equipment
– Check the voltage of the equipment when performing the electrical
installation. – Place the equipment at a place that will not get wet. –
Install the equipment at a place where it will be not damaged by pressure,
temperature, direct solar light, powder and salt. – The equipment shall not be
submitted to bending, excessive vibrations or shocks (including while
transporting and handling). – This equipment was not designed for the use at
an environment where fumes, inflammable anesthetic mixtures with the air or
oxygen and nitrous oxide can be detected. – Before the first use and/or after
long work interruptions such as vacations, clean and disinfect the equipment.
– This equipment is not sensible to electrical interference; electrostatics
and pressure, since cleaning items, maintenance, transport and operation of
this manual are observed. However, an electromagnetic environment can
interfere in its normal operation.
Precautions and warnings “during the use” of the equipment
– The equipment must only be operated by technicians duly qualified and
trained (Dental Surgeons and Capacitated Professionals). – In case of a casual
maintenance, only use the services of a Alliage’ Authorized Technical
Assistance. – Do not submit the plastic parts to contact with chemical
substances used in the dental treatments routine Such as: acids, mercury,
acrylic liquids, amalgams, etc. – Avoid that the light conductor’s terminal
touch the resin to be polymerized. – When using the photopolymerizers, check
if the outlet of the conductor has no residues that can occlude the light
beam. – Use appropriated techniques for minimizing the effects of the
contraction of the photo polymerized material and also of the temperature on
the applied region; these techniques consist of a proportional detachment from
the expected effect, which means that detaching the tip from the activated
region, the power and the temperature tends to diminish. – A minimum distance
of 10mm between the Light conductor and the tooth is recommended.
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. – The batteries should not be stored
inside the equipment if it becomes unused for some time. When it’ is not using
the equipment, we advise you to remove the batteries, because they are
corrosive and can, throughout time, release the acid and cause damage to it. –
When observing the presence of irremovable stains, cracks or fissures on the
light conductor and ocular protection, provides the replacement of the damaged
components.
20
PRECAUTION, RESTRICTION AND WARNING
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: 0,230 X 0,130 X 0,055 / MASS: About: 0,550 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.
21
CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
Additional procedures for reuse
The equipment can be reused in undetermined, i.e. unlimited, quantities, only
needing to be cleaned and disinfected.
Cleaning
- Handpiece and battery: Wipe dry with a clean, damp cloth to remove visible
residue. 2) Light conductor: Rinse with tap water and dry with a dry cloth.
Attention
When cleaning manually, the Light conductor should check the end face for dirt. If it is, please use a plastic tool to remove it carefully. Do not use metal equipment. Do not touch any hard objects on the end of the Light conductor to avoid scratching.
Disinfection
The Handpiece and battery can be surface wiped with 75% ethanol. Light conductor and ocular protector can be immersed in 75% ethanol for 30 minutes.
Attention
Do not use chlorine-containing disinfectants and do not use ultrasonic cleaning.
Drying
After cleaning and disinfection, please dry, it is recommended to use compressed air to dry.
Sterilization - Sterilizable parts: Light conductor. 2) Please use a sterilization bag that
meets national regulations before packaging. 3) Sterilization method:
Recommended for autoclaving. 4) Sterilization conditions: 134 ° C, not less
than 4 minutes or 121 ° C, not less than 20 minutes.
Warning - Handpiece/ocular protector are strictly prohibited. 2) The maximum
sterilization temperature should not exceed 136 °C.
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CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
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.
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UNFORESEEN EVENTS SOLUTION OF PROBLEMS
Attention 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.
ImPprorebvleismtos
PPrroovbáavbelel Ccaauussae
SSoolluuçtõioens
-Equipment inoperative. “Display with no show”.
-Handpiece battery without charge. -Overheating Protection. -activated “Error code: Er”.
-Recharge the handpiece on the base for 4 hours. -Wait the cooling for some minutes.
– The battery doesn’t charge.
-Bad connection between the supply source and the handpiece. -Battery failure.
-Restore the connection.
-Get in touch with Alliage’ technical assistance.
-The equipment is not polymerizing the resins.
-Non appropriated resin for the wavelength of LED photopolymerizers.
-Light conductor incorrectly.
-Resin residue in the light conductor. -Light conduct or with protection cover.
-Buy the appropriated resin for the wavelength of the polymerizer, that is, which contains photo initiators with camphorquinone. -Correctly attach the light conductor fixed. -Clean the light conductor.
-Remove the protection cover of the light conductor.
-Inadequate Luminous power.
-Light conductor incorrectly fixed. -Problems with light conductor.
-Reduced battery’s capacity.
-Fix correctly the light conductor. -Substitute the light conductor. -Contact Alliage’ technical assistance.
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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.
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