SAEVO Optilight Max User manual

2
PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
ATTENTION
Technical Name: Equipment for dental bleaching and photopolymerization of resins.
Trade Name: Curing Light Optilight Max
Model: Optilight Max
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
Phone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
Registration ANVISA #: 10069210081
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.

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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
11 Electromagnetic emission
15 Dimensions
16 Packing symbols
16 Simbologias do produto
17 INSTALLATION OF THE EQUIPMENT
18 OPERATION OF EQUIPMENT
20 PRECAUTIONS, RESTRICTIONS AND WARNINGS
20 Recommendations for the equipment’s conservation
20 Transport conditions, warehousing and operation
21 Sensitivity to predictable environmental conditions in ordinary situations of use
21 Precautions and warnings “during the installation” of the equipment
21 Precautions and warnings “during the use” of equipment
22 Precautions and warnings “after” the use of equipment
22 Precautions and warnings during “cleaning and disinfection” of the equipment
22 Precautions in case of alteration in the functioning of equipment
22 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation
and abandoning of equipment
23 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
23 Additional procedures for reuse
23 Cleaning
23 Disinfection and sterilization
24 Preventive Maintenance
24 Corrective Maintenance
25 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
26 EQUIPMENT’S WARRANTY
26 FINAL CONSIDERATIONS

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IDENTIFICATION OF EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a SAEVO QUALITY product
comparable to the best products available in the World. This manual is a general presentation of
your product and it will give you important details to help you to solve possible problems.
Please, read it and keep this with you.
IDENTIFICATION
Technical Name: Equipment for dental bleaching and photopolymerization of resins.
Trade Name: Curing Light Optilight Max
Model: Optilight Max
Brand: Saevo

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IDENTIFICATION OF EQUIPMENT
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 dierent 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 dierent dental products
to which it applies.
LED technology, recently introduced in Dentistry, has brought countless advantages to the curing
light appliances for direct restorations in composite resin. Besides being innitely more durable, the
LEDs have made the appliances more compact, ergonomic and easy to install and transport. The
emission of cold light at a precise wavelength ensures the polymerization of composites activated
by the canforoquinone, without risks of dental heating, pulpal injury or discomfort for operator
and patients.
The safety and eciency of the LEDs, now with high emission power, are available for all the clinical
procedures which require power of light for photoactivation.
The wavelength of 420nm - 480nm associated with the high power emitted by the Optilight Max
makes the multifunctionality of this appliance feasible:
• Direct restoring procedures: composite resins, ionomers and adhesives.
• Indirect restorations: adhesive cementing of laminates, inlays, esthetic pegs and metal-free crowns.
• Activation of photoactivated materials as sealers, surgical cements and lining bases.
Planned and built using cutting-edge technology, to provide results within the specications
stipulated by the leading world dental authorities.
Endowed with an automatic bivolt switch power supply which allows one to use the equipment at
any power supply voltage between 100 and 240V~ - 50/60Hz.
Digital control in the display on the handpiece itself.
Variance of choice of operating time (5,10,15 and 20 seconds).
It has 3 application modes: Continuous, Ramp and Pulsating:
•Continuous: Maximum and continuous mode of light intensity (same luminosity from start to
nish of the polymerization).
• Ramp: Gradual mode of light intensity; it increases gradually.
•Pulsed: Pulsing mode consisting of cycles which oscillate at a xed frequency.
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 480nm
(blue light), which has an ideal intensity for being integrated with the canforoquinone.
Indication of the equipment
This equipment is exclusively for dental use, having to be employed and handled by a capacitated
person (professional duly regulated, as per the local legislation of the country) observing the
instructions contained in this manual.
The user is obliged to only use the equipment in perfect conditions and protect himself/herself,
patients and third parties against possible hazards.
Purpose of the equipment
This equipment is exclusively for dental use, with the objective of polymerizing photosensitive
substances through the emission of blue light.
It was developed to be used in several dental procedures such as: restoring procedures, bonding
braces and activating photoactivated materials as sealers, lining bases.

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Advantages oered by Optilight Max:
- More spectrally-selective light than conventional lamps.*
- Cold light, it doesn’t heat up the resin nor the tooth**
• Light compact equipment that provides handling comfort.
• Low power consumption.
• Longer useful life of the light emitting diode (equivalent to 36.000.000 cycles of 10 seconds).
• It does not use optical lter.
• It does not require forced ventilation, thus avoiding noise emission.
*We noted that the light emitted by the Optilight Max is completely contained within the absorption
interval of the photo starter, therefore it’s 100% used, whereas the conventional equipment running
on halogen lamps has non-used wave-length regions.
** The Optilight Max doesn’t generate heat since it uses light emitting diodes.
The light conductor is removable, made out of high resistance polymer and of easy maintenance.
Light conductor with ber optics, rotating, removable and easy to sterilize, with a front protector of
the tip against scratches and the accumulation of undesirable residue. The reduced weight of the
penand its anatomic design ensure that the professional’s work is more comfortable and practical.
Support for the handpiece, which ensures easy access and handling.
IDENTIFICATION OF EQUIPMENT

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

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Accessories which come with the product:
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.
Handpiece Light Protection
Shield
Charging base
Power supply sourceLight Conductor
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

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TECHNICAL SPECIFICATIONS
Power Supply
Ve: 100 - 240V~ - 50/60Hz
Vs: 5V - 1,5 A
Frequency
50/60Hz
Source Power
8VA
Light Source
1 LED
Light Power
1200 mW/cm2 ± 200 mW/cm2
Semicondutor LED (InGaN)
Wavelength
420nm - 480nm
Timer
5,10,15 and 20 seconds
Time Sounder
a “beep” every 05 seconds
Activation
Through the handpiece button
Light Conductor
Optics ber 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
Classication of the Product
As per standard NBR IEC 60601-1
Type of protection against electric shocks
Class II Equipment
General features

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Degree of protection against electric shocks
Applied part of Type B
Degree of protection against harmful penetration of water
IPX 0
Degree of saf ety of application in the presence of an anesthetic mixture inf lammable with
air, oxygen or nitrous oxide
It is not suitable
Battery of Li-ion
DC 3,7V 2200mAh
Approximate time f or recharging battery
3h
TECHNICAL SPECIFICATIONS

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Electromagnetic emission
Electromagnetic Emissions
The Optilight Max is made to be used in the electromagnetic environments specied below. The
client or the user of the Optilight Max 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 Max 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
Emissions of harmonics
IEC 61000-3-2
Class A This Optilight Max is proper to be used
in all establishments; including domestic
settings and those directly connect to a
public low voltage distribution which feeds
domestic buildings.
Fluctuation of Voltage /
Emissions of icker
IEC 61000-3-3
As per
TECHNICAL SPECIFICATIONS

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Guidelines and manufacturer's declaration - electromagnetic immunity
The Optilight Max is made to be used in the electromagnetic environments specied below.
The client or the user of the Optilight Max 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 Max 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

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Guidelines and manufacturer's declaration - electromagnetic immunity
The Optilight Max is made to be used in the electromagnetic environments specied below. The
client or the user of the Optilight Max 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 Max, 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 Max 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 Max.
b - Whether above the frequency range of 150kHz to 80 MHz is recommended a eld intensity
below than 3 V/m.
TECHNICAL SPECIFICATIONS

14
Recommended distances between portable and mobile RF communication equipments and the
Optilight Max
The Optilight Max is made to be used in an electromagnetic environment in which RF disturbances
are controlled. The client or the user of the Optilight Max may help preventing electromagnetic
interference by keeping a minimal distance between mobile and portable RF communication
equipment (transmitters) and the Optilight Max, 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

15
Dimensions (mm)
TECHNICAL SPECIFICATIONS

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Packing symbols
Simbologias do produto
TECHNICAL SPECIFICATIONS
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.
Authorized representative in the
European Community

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INSTALLATION OF THE EQUIPMENT
Charge the battery during 08 hours
before using the equipment for the
rst time.
• For your safety the Optilight Max has an
automatic bivolt power supply source of 100V~
- 240V~ - 50/60Hz.
• Connect the cable of the power supply source
(12) to the charging base (06) and the power
supply source (10) in the socket.
• Insert the light conductor (01) in the handpiece
(04).
• Remove the protection cover (13) from the
light conductor.
• Insert the light protection shield (02) in
the light conductor and place the assembled
equipment in the charging base.
02
13
01
10
04
06
12

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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 nish of
the polymerization).
- Ramp: Gradual mode of light intensity; it increases gradually.
- Pulsed: Pulsing mode consisting of cycles which oscillate at a xed frequency.
The application mode chosen will be viewed in the sequence of LEDs (15).
• In order to schedule the time press the button (08) and choose the time 5 thru 20 seconds, which
will be viewed in the display (07).
• After selecting the mode of application and the choice of time, take the handpiece to the patient’s
mouth and position the light guide at a safe distance.
• In order to start the polymerization cycle, press the start button (05). To interrupt it Just activate
it again.
09
08
15
07
Hand piece
INCORRECT
positioning for
battery charging.
Hand piece
CORRECT
positioning for
battery charging.
Continuous
Ramp
Pulsed
14
05

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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 increases
gradually.
•Gradual increase = 500 - 1200 mW/cm²*
• Pulsed:
Pulsing mode consisting of cycles which oscillate
at a xed frequency.
• On/o every 1sec. maximum power =
1200 mW/cm²*
* Tolerance is ± 200 mW/cm²
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 eect and can be recharged even if it is not completely
discharged.
OPERATION OF EQUIPMENT

20
Automatic disconnection:
The equipment will be turned o 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 o
automatically. In order to turn it on again, press the on/o button.
WARNING:
- Never point the blue beam of light at anybody’s eyes;
- Protect the visual eld 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 eld.
- After use always maintain the light conductor protected by the protection cover.
PRECAUTIONS, RESTRICTIONS AND WARNINGS
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.
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;
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.
OPERATION OF EQUIPMENT