SAEVO Optilight Max User manual

2
PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
CAUTION
Technical Name: Equipment for tooth whitening and resins’ photopolymerizers.
Trade Name: Curing Light Optilight Color
Model: Optilight Color
Brand: Saevo
Manufacturer / Distribuitor:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Telefone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
Registration ANVISA #: 10069210078
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.

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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 to be adopted against foreseeable or uncommon risks, related to the deactivation
and abandoning of equipment
21 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
21 Additional procedures for reuse
21 Cleaning
22 Disinfection
22 Preventive Maintenance
22 Corrective Maintenance
23 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
24 EQUIPMENT’S WARRANTY
24 FINAL CONSIDERATIONS

4
IDENTIFICATION OF EQUIPMENT
Dear Customer
Congratulations for your excellent choice. When buying equipments with “Saevo” quality, you can
be sure of the acquisition of products with a technology comparable to the world’s best in its kind.
This manual oers 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 eectively
occur.
We advise its complete reading and conservation for further consults.
IDENTIFICATION
Technical Name: Equipment for tooth whitening and resins’ photopolymerizers.
Trade Name: Curing Light Optilight Color
Model: Optilight Color
Brand: Saevo

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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 dierent 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 innitely 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 eciency 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 450nm to 470nm 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
specications 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.
• Pulse: Pulse mode has cycles that oscillate at a xed frequency.
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
450nm a 470nm (blue light), which has the ideal intensity for integrating with camphorquinone.
Indication of Equipment
This equipment is for dental use only and must be used and handled by a qualied person
(professional properly regulated in compliance with the Country’s local legislation) observing the
instructions contained in this manual.
It is the user’s obligation to only use the equipment in perfect conditions and protect himself,
patients and third parties against potential hazard.
Purpose of the equipment
This equipment is for dental use only aiming to photo polymerize photo sensible substances through
the emission of a blue light.
It was designed for being used in several dental processes such as: Restorative procedures, bracket
bonding and activation of material photo activated as sealant, liner bases.
IDENTIFICATION OF EQUIPMENT

6
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 lter.
• 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 ber, 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.
IDENTIFICATION OF EQUIPMENT

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
01
02
04
03
01 – Light conductor
02 - Handpiece
03 – Power supply unit
04 - Base
A - Commands
B - Indicative LED for the battery level
A
Time adjust
button
Visor “display”
Continuous mode
Ramp mode
Pulse mode
On / O button
Application mode
selector button
B
Green: Full charge
Red: Loading
LED
Available in colors.

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Accessories that come with the product:
HANDPIECE
BASE
OCULAR PROTECTOR
POWER SUPPLY UNIT
BATTERY
LIGHT CONDUCTOR
The content of this page is for informative purpose, so the equipment can present itself dierent 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 specied nor foreseen in those use operation instructions
and it is of the user’s entire responsibility.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

9
TECHNICAL SPECIFICATIONS
Voltage (Power Supply Unit)
Ve: 100 - 240V~ - 50/60Hz (Bi-volt)
Vs: 5V - 1.5 A
Light source (1 LED)
Power (Maximum): 5W
Light power: 1200 mW/cm2 ± 200 mW/cm2
Semi-conductor LED (InGaN)
Wavelength: 450nm - 470nm
Li-ion battery
DC 3.7V 2200mAh
Time for full battery charge
4h
Light conductor
Optic ber 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 - B Type’s applicated part
Protection grade against the penetration of nocive water
IPX 0
General features

10
Electromagnetic emission
The Optilight Color is made to be used in the electromagnetic environments specied 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 This Optilight Color uses RF energy
only for internal functions. However, its
emissions are too low and it's unlikely to
cause any interference in the equipments
next to it.
RF emissions
ABNT NBR IEC CISPR 11
Class B This is proper Optilight Color to be used
in all establishments; including domestic
settings and those directly connect to a
public low voltage distribution which feeds
domestic buildings.
Emissions of harmonics
IEC 61000-3-2
N/A Power <75W
SeeEMC
5.1.1- 61000-3-2
5.1.2- 61000-3-3
Fluctuation of Voltage /
Emissions of icker
IEC 61000-3-3
N/A
Electromagnetic emission
TECHNICAL SPECIFICATIONS

11
Guidelines and manufacturer's declaration - electromagnetic immunity
The Optilight Color is made to be used in the electromagnetic environments specied 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
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wooden,
concrete or ceramic. If
the floor is 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 in power
supply lines
± 1 kV in input /
output lines
± 2 kV in power
supply lines
± 1 kV in input /
output lines
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Surges
IEC 61000-4-5
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Reduction,
interruption
and variance of
voltage in power
supply input lines
IEC 61000-4-11
< 5% Ut
(>95% drop in Ut)
for 0,5 cycle
40% Ut
(60% drop in Ut)
for 5 cycles
70% Ut
(30% drop in Ut )
for 25 cycles
< 5%Ut
(>95% drop in Ut )
for 5s
< 5% Ut
(>95% drop in Ut )
for 0,5 cycles
40% Ut
(60% drop in Ut)
for 5 cycles
70% Ut
(30% drop in Ut )
for 25 cycles
< 5% Ut
(>95% drop in Ut )
for 5s
The recommended power
supply quality is the same
as used for commercial or
hospital environment. If
is required a continuous
use during energy supply
outages, it is recommended
that the Optilight Color be
feed by an uninterruptible
power supply or a battery.
Magnetic field
in frequency of
power supply
(50/60Hz)
IEC 61000-4-8
3 A/m 0,3 A/m If an image distortion occurs,
may be necessary place
the equioment far from
the supply frequency or to
installa magnetic armour.
The frequency magnetic
eld shall be measured at
the installment place to
assure that it is low enough.
NOTE Ut is the a.c. power supply voltage before the application of the test level
TECHNICAL SPECIFICATIONS

12
Guidelines and manufacturer's declaration - electromagnetic immunity
The Optilight Color is made to be used in the electromagnetic environments specied 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
RF conducted
IEC 61000-4-6
RF radiated
IEC 61000-4-3
3 vrms
150 kHz up to 80 MHz
3 V/m
88 MHz up to 2,5 GHz
3 Vrms
3 V/m
It is advisable that portable and mobile RF
communication equipment is not used near
any part of the Optilight Color, including
cables, with a separation distance less
than the one recommended, calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 1,2√P
d = 1,2√P 80 MHz thru 800MHz
d = 2,3√P 800 MHz thru 2,5MHz
Where P is the nominal maximum power of
output of the transmitter in watts (W), as
per the manufacturer of the transmitter,
and d is the recommended separation
distance in meters (m).
It is advisable that the el intensity from
the RF, transmitter as determined by
means of electric inspection on-sitea,is
less than the level of compliance in each
frequancy rangeb.
There may be interference near the
equipment marked with the following
symbol:
NOTE 1 At 80MHz and 800MHz, the highest frequency range applies.
NOTE 2 These directives may not be applicable in every situation. The electromagnetic
transmission is aected by the absorption and reection of structures, objects and people.
a - The eld intensities set by the xed transmitters, such as radio base stations, telephones
(mobile phone, wireless) land mobile radio, amateur radio, AM and FM radio transmissions and TV
transmissions can not be predicted with accuracy. Due to the RF xed transmitters is recommended
to install an electromagnetic inspection at the local in order to evaluate the electromagnetic
environment. If at the place where the Optilight Color is be using the eld intensity level exceeds
the conformity level for the RF above, is recommended to observe if the operations
are normal. Whether abnormal operations are observed, additional procedures shall be necessary
such as reorientation or replace the Optilight Color.
b - Whether above the frequency range of 150kHz to 80 MHz is recommended a eld intensity
below than 3 V/m.
TECHNICAL SPECIFICATIONS

13
Recommended distances between portable and mobile RF communication equipments and the
Optilight Color
The Optilight Color is made to be used in an electromagnetic environment in which RF disturbances
are controlled. The client or the user of the Optilight Color may help preventing electromagnetic
interference by keeping a minimal distance between mobile and portable RF communication
equipment (transmitters) and the Optilight Color, as recommended below, in accordance with
the maximal voltage output of the communication equipment.
Transmitter Maximum
Output (W)
Separation distance according to transmitter frequency (M)
150 kHz to 80 MHz
d= 1,2√p
80 kHz to 800 MHz
d= 1,2√p
800 kHz to 2,5 GHz
d= 2,3√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 with a maximum nominal output power not listed above, the recommended d
separation distance in meters (M) can be determined using an equation applicable to the frequency
of the transmitter, where Pis the transmitter maximum nominal output in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, is applied the separation distance for the higher frequency range.
NOTE 2 These guidelines may not apply to all situations. The absorption and reection from
structures, objects and people aect the electromagnetic propagation.
TECHNICAL SPECIFICATIONS

14
Dimensions (mm)
TECHNICAL SPECIFICATIONS

15
Packing symbols
Product symbols
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 avoiding humidity,
rains and wet oor.
Packing to be transported and /
or stored with the harrows up.
The packing must be stored and
transported away from direct
sun light exposure.
Packing to be transported and /
or stored with care (should not
suer drop and neither receive
impact).
Temperature limit for the packing
to be stored or transported.
Applied part type B.
General warning:
If the instructions are not properly
followed, the use can lead to
damage to the product, user or
patient.
Attention:
Check the working instructions.
Note:
It indicates useful information for
operation of the product.
Refer to the instruction manual.
Grounding (at several points of the
equipment) indicates the condition
of being grounded.
TECHNICAL SPECIFICATIONS

16
INSTALLATION OF EQUIPMENT
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.
Charge the battery during 08 hours before using the equipment for the rst time.
1 2 3
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.
4hours
4 5
click

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OPERATION OF EQUIPMENT
- Press the button to turn on the equipment (g.1).
- Select the application mode pressing the selection button (g.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 xed 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 (g.3).
-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 (g.4).
- For starting the polymerization
cycle, press the trigger. Just
trigger again to interrupt (g.5).
1 2 3
Press
Press
Press
4 5
10mm
Press
beep
beep
beep
ATTENTION
Low battery warning:
- When the display shows the symbology and sound
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 eect and can be recharged,
even if it’s not completely discharged.
A

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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 xed
frequency.
• On/O at each 1sec. maximum power =
1200 mW/cm²*
* Tolerance of ± 200 mW/cm²
Automatic shutdown:
The equipment will turn o automatically when not in use for more than 3 minutes. For
turning it on again, press the On / O button.
IMPORTANT:
- Never address the light beam to the eyes;
- Protect the visual eld using the ocular protector;
- The ocular protector has the goal of ltrate 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 eld.
- After using it, keep the light conductor protected by the protection cover.
OPERATION OF EQUIPMENT

19
PRECAUTION, RESTRICTION AND WARNING
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 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;
ATTENTION: The equipment must be only used with the power cable supplied by Saevo, 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 ecacy, 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 elds, external
electrical inuences, 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.
Recommendations for the equipment’s conservation
Your Saevo 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.

20
Precautions and warnings “during the use” of the equipment
Precautions and warnings “after” the use of equipment
- Turn the equipment o while in not in use for a long time.
- Carry out the cleaning and disinfection after the use of the equipment, including in the rst 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 ssures on the light conductor and
ocular protection, provides the replacement of the damaged components.
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, inammable anesthetic
mixtures with the air or oxygen and nitrous oxide can be detected.
- Before the rst 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.
- The equipment must only be operated by technicians duly qualied and trained (Dental Surgeons
and Capacitated Professionals).
- In case of a casual maintenance, only use the services of a Saevo’ 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 eects 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 eect, 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.
Saevo shall not be responsible for:
- Use of the equipment diering 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, diering from those described in these Instructions for
use which come with the equipment or by the incorrect operation of it.
PRECAUTION, RESTRICTION AND WARNING