BG Light BLUEDENT SMART cordless Instruction Manual

OPERATING INSTRUCTIONS MANUAL
BLUEDENT SMART built-in
24V / 12V / 220V
Dental LED curing light
Ref.#200-005b, #200-005m

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LED curing light
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LED curing light
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Thank you for trusting our products!
Carefully read this Operating instructions manual before installing and operating the
unit to use and maintain it successfully!
Save this Operations guide for your reference in the future.
CONTENTS:
I. UNIT DESCRIPTION AND FUNCTION
II. SYMBOLS
III. SAFETY PRECAUTIONS
IV. TECHNICAL DATA
V. COMPLETE SET
VI. PREPARATION AND SEQUENCE OF OPERATION
VII. ROUTINE CARE AND MAINTENANCE
VIII. WARRANTY CONDITIONS
IX. SERVICE DATA
X. FAQ
XI. DECLARATION OF CONFORMITY
XII. BLUEDENT DATA
I. UNIT DESCRIPTION AND FUNCTION
Dental LED curing light BLUEDENT SMART built-in is an accessory to a medical device
- specialized light source for intraoral polymerization of dental materials, sensitive to
the blue part of the light spectrum.
The device is intended for use only by a qualified dental practitioner and in a dental
practice.
BLUEDENT SMART built-in consists of Handpiece with cable (and adapter for 220V
version) and Holder for attaching to the dental chair.
BLUEDENT SMART built-in is manufactured in conformity with the requirements of
Regulation on medical devices MDR 2017/745 and standards ISO 13485:2016, ISO
9001:2015.

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LED curing light
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II. SYMBOLS
Caution!
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a variety of
reasons, be presented on the medical device itself.
Consult instructions for use
Indicates the need for the user to consult the instructions for use.
Dangerous voltage
To indicate hazards arising dangerous voltage.
Hazardous light emission
To indicate hazards arising from light radiation.
Hazardous thermal effects
To indicate hazards arising from thermal effects.
Manufacturer
Indicates the medical device manufacturer.
Date of manufacture
Indicates the date when the medical device was manufactured
Medical Device
Indicates the item is a medical device
Unique Device Identifier
Indicates a carrier that contains Unique Device Identifier information
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can be
identified.
Serial number
Indicates the manufacturer's serial number so that a specific medical device can be
identified.

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Batch code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Applied part type B according to electric safety classification
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Waste Electrical and Electronic Equipment (WEEE)
According to Directive 2012/19/EU, this symbol indicates that the product
should not be disposed of as urban waste at the end of its operating life.
Fragile
Indicates a medical device that can be broken or damaged if not handled carefully.
European Conformity
Indicates conformity with local laws and regulations within the European Economic Area

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III. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLUEDENT is a Class I accessory to a medical device and it meets the strict
requirements of the Medical Devices Regulation - MDR (EU) 2017/745. In order to be
used safely for staff and patients, the following rules must be observed:
- Do not allow unauthorized and untrained personnel to use the device to avoid risks.
- Disconnect the device from the mains after completing the procedures.
- Do not use or store the device in a dusty environment.
- Do not expose the device to direct sunlight.
- Do not spray disinfectant directly into the device - only rubbing with a swab drained
of disinfectant is acceptable.
- Do not get wet or drop liquid on the device, cables, adapter to avoid electric shock
or damage to the device.
- Store the device in a dry place, moisture can cause electric shock and damage.
- In case of a problem, disconnect the device from the mains, do not to make
attempts to repair, take the device to a service center.
- The device must not be used if any of its parameters are not normal (timer, light
intensity, heat radiation).
- The bleaching head must not be covered, the cooling openings must not be closed
so as not to cause the device to overheat and ignite.
- Strong electromagnetic fields in the building can cause interference and
malfunction of the device. If their source cannot be determined, change the location
of the device and plug it into another socket or other room, even in another building.
- Opening and repairing the appliance may only be carried out by authorized service
technicians from the manufacturer.
- Only original BLUEDENT parts must be used when replacing defective parts. The
warranty of the device does not cover the damage caused by the use of non-original
spare parts. The device or any of its parts must not be disassembled while it is
connected to the mains!
- Fragile! Use caution when transporting, using and storing the device!
- According to Directive 2012/19/EEC, this symbol indicates that the product
should not be disposed as a general waste at the end of its lifespan. The product
must be taken to a specialized center for the separate collection of electrical and
electronic equipment according to local regulations. Proper disposal of equipment
that is no longer used prevents negative consequences for the environment and
human health!

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- In accordance with the requirements of MDR (EU) 2017/745, user and / or the
patient must report any serious accident that have occurred during us of the device
to the manufacturer and the competent authority of the Member State in which the
user/patient is established.
- All packaging materials of the product must be kept away from children to avoid
risks of injury / suffocation.
SAFETY MEASURES AND RISKS
The device must be used in strict accordance with the Operating Instructions Manual.
1. Electrical safety
Before starting the appliance, make sure that the voltage and the type of plug
correspond to the mains supply in the country. Electrical safety is ensured by class II
protection against electric shock according to EN 60601-1.
BLUEDENT must only be operated indoors, under the following conditions:
- temperature from + 10 ° to + 40 ° С;
- relative humidity 30 - 75%;
- lack of dust in the room;
- atmospheric pressure 700 - 1060 hPa;
- absence of chemically active and flammable substances;
- no part of the device should be wetted or immersed in water;
- the device or any of its parts must not be disassembled while it is connected to the
mains!
Protect the cables of the appliance from insulation damage and breakage from sharp
objects, strong pulling, rodents, chemicals. If such damage is noticed on the electrical
cables, it is necessary to take the device immediately to the company service. The
device must not be used with damaged cables.
In case of thunderstorms, the procedures must be stopped and the plug must be
disconnected from the mains.
Risk: Failure to comply with these instructions may result in electric shock to users of
the device.

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2. Light radiation
BLUEDENT is a source of extremely intense light in the blue range, to which the
human eye has a high sensitivity. This results in serious measures to be taken for
patients, medical staff and accidentally nearby people, animals and plants.
As such, use protection goggles for the operator.
Irradiation of the eyes and skin with intense light carries a risk of damage from light
and heat.
The light should never be directed at the eyes! Irradiation should be limited to the
workplace area. The special safety goggles from the set that meet the requirements
must be used:
- to cover the eyes and temples tightly, even if the person is wearing optical glasses.
- be made of volumetric colored impact-resistant plastic.
- do not transmit light with a wavelength of 380 - 600 nm.
- reduce the intensity of the blue spectrum by more than 100 times.
- have a stable mechanical structure, no scratches, cracks and damage to its surface.
The device can be used only after a doctor's consultation on or by persons suffering
from photo-biological reactions; persons taking photosensitive drugs; persons
undergoing cataract surgery, persons with retinal diseases, etc.
The risk of improper irradiation is severe eye irritation, temporary spots in the visual
field, severe visual impairment in direct radiation, to loss of vision.
3. Thermal radiation
The thermal effect is due to the absorption of the energy of the blue light in the
tissues, during which the energy is converted into heat. The risk is only with
prolonged overdose.
Risk of pain, burning of soft tissues.

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4. Fire safety
- Keep the device away from solvents, flammable liquids and powerful heat sources.
- Do not expose to direct sunlight.
- Do not allow liquids and detergents to enter the device, as this may cause a short
circuit and fire or cause potentially dangerous damage.
- If the product emits an odor or smoke –disconnect from the mains, do not attempt
to repair it, take it to a service center.
Risk of fire, explosion and damage.
5. Contraindications:
- The device can be used only after medical consultation on or by: persons with
implanted cardiac pacemaker; persons suffering from photobiological reactions;
persons taking photosensitive drugs; persons undergoing cataract surgery; persons
with retinal diseases; people with allergies; people who have recently undergone
cosmetic surgery on the face or lips, including injections of hyaluronic acid or botox;
people with very sensitive skin or dermatitis, etc. If you are taking photosensitizers or
medicines, check the package leaflet.

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IV. TECHNICAL DATA
1. Operating voltage:
–24V AC/DC or 110-240V / 50-60Hz
(depending on specification of device)
2. Power consumption:
- 24V AC/DC –0,35А
- 110-240V / 50-60Hz –0,115А
3. Dimensions (approx.)
- Cordless handpiece - diameter - 32mm; length (with lightguide) - 196mm
4. Weight of handpiece (incl. lightguide) –245g
5. Polymerization modes –RAMP (R), PULSE (P), LONG (L), FAST (F).
6. Emitted light –blue, visible spectrum, 410-490 nm.
7. Light source –2 band LED module with reflector optics.
8. Light intensity - up to 1300 mW/sq.cm
9. Emitting time:
- 10 / 20 / 30sec
- 1-9 min (±5%)
10. Audible signal every 10 sec / 1 min according to the selected mode.
Possibility to turn on / off the sound signal.
11. Digital display for the selected mode and countdown timer.
12. Micro fan cooling.
13. Fiberoptic lightguide (rotatable 360 degrees)
14. Working mode (1 min. work / 10 min. pause)
15. Degree of protection against electric current - applied part type B.
The manufacturer of this unit declares to provide on request all additional necessary technical
documentation / information which will help the user’s technical staff to service the parts of the
unit which the manufacturer has claimed to be a subject for repair.

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V. COMPLETE SET
1. Charging adapter 100-240V AC / 24V DC - 1 pc. (for 220V model with
adapter)
2. Emitting handpiece - 1 pc.
3. Holder - 1 pc.
4. Protection filter and cap –1 pc.
5. Operations guide - 1 pc.
Version 24V / 12V
Version 220V with adapter
Control and indication:
1. Emitting LED module
2. Start / Stop button
3. Cable

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VI. PREPARATION AND SEQUENCE OF OPERATION
BLUEDENT SMART built-in is designed for use as a cable powered unit to be built-in
the dental chair (version 24V / 12V) or to be powered by the mains (version 220V
with adapter).
1. Take the curing light out of the packing. The holder is fixed on a suitable vertical
surface with the included fasteners.
2. By turning off the power to the dental chair, the power to the BLUEDENT SMART
built-in (version 24V) is also turned off.
For version 220V - at the end of the day the charging adapter should be disconnected
from the mains.
3. Mount lightguide and protection shield or protection cap.
See VII. ROUTINE CARE AND MAINTENANCE for instructions of initial cleaning and
mounting.
NOTE: Lightguide and protection cap must be sterilized before every use!
They are delivered in a non-sterile state and must be sterilized beforehand first use.
Before each patient, the light guide (only it, without the handpiece) must be cleaned
mechanically and then with a disinfectant (e.g. Desident CaviCide or another
approved by the Ministry of Health) and sterilized by autoclaving at 134 ° C for 5
minutes.

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LED curing light
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(1)
For polymerization of posterior teeth
(attach as shown)
(1) Protection cap
For polymerization of anterior teeth /
general application
4. BLUEDENT SMART has 4 work modes, which guarantee fast polymerization and
complete hardening of the photocomposite material. The selection of the mode is
done by pressing the MODE button located below the left side of the display:
R - RAMP L - LONG F - FAST P - PULSE
R - RAMP mode (10 - 20 - 30 sec)
During the first 3 seconds, the light intensity slowly
increases to avoid stress in the photocomposite.
L - LONG mode (1-9 min)
The light intensity is at a maximum level of 100%, the
mode is suitable for long procedures, e.g. teeth
whitening.

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F - FAST mode (10 - 20 - 30 sec)
The emitted light has a high intensity - 100% without a
soft start to achieve complete polymerization.
P - PULSE mode (10 - 20 - 30 sec)
It emits pulsating light, which helps reduce shrinkage in
the photocomposite.
It also reduces the patient's thermal sensation.
1.Curing mode display
2.Timer display
3.Selection of curing mode
4.Selection of timer
The timer is selected by
pressing the “TIMER”
button.
The horizontal light line
on the right shows the
selected time -
10, 20, 30 sec / with
timer 9 min.
the display shows min.
(In this example, the
display shows RAMP mode
with a timer time of 20
sec.)
5. The device is started by pressing Start / Stop
probe button - see figure.
After starting, the timer starts counting down.
An audible signal sounds every 10 seconds.

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6. The handpiece is aimed at the place designated for irradiation, the tip of the
lighguide is brought as close as possible to the object of irradiation (4 - 7 mm) and
after a few seconds when the surface layer has hardened enough, it can be irradiated
contact.
7. After pressing the Start / Stop button again or after the selected time has elapsed,
the device stops. If a next irradiation cycle is required, it can be restarted without
waiting. During prolonged operation, it is possible that the fan cooling switches on.
8. The dental curing light is switched off at the end of the day by disconnecting the
charging adapter from the mains.
9. “SLEEP” function
The wireless handpiece has a "sleep" function, which helps reduce energy
consumption. The handpiece goes into sleep mode:
- when it is placed on the charging base and is fully charged;
- when it does not emit light and is not started for more than 30 sec. outside the
charging base;
Pressing the Start / Stop button once wakes up the device. The display shows the last
selected time and operating mode.
10. "SOUND SIGNAL OFF" function
This function allows you to turn the sound of the device on and off. The MODE
button is held for 5-6 seconds, the sound signal indication is heard and the sound ON
/ OFF setting is changed automatically:
If the sound signal is ON, after holding down the MODE button, OFF is displayed and
the sound is turned off.
If the sound signal is OFF, after holding down the MODE button, ON is displayed and
the sound is turned on.
11. Thermal protection
It can be switched on during prolonged operation
fan cooling.
In the event of an extreme temperature rise, the light will
stop, the display will show “Oh” (Overheating), and the fan
will continue to run until the unit cools down. It takes a few
minutes.

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VII. ROUTINE CARE AND MAINTENANCE
1. Examining of lightguide / protection cap.
Lightguide is mounted / dismounted by pulling (360 degrees rotatable).
Every day the lightguide tip should be examined for:
- stuck restorative material (it should be removed very carefully with blunt non-metal
object);
- mechanical damages on the lightguide.
Remove the light guide and looking through it at strong light: if there are darkened
areas over 10% of the area, replace it with a new one.
OK
Defective
Lightguide should be sterilized by autoclave at 134° C for 5 min.
The same must be done for protection cap.
The protective filter is wiped only with disinfectant.
2. Cleaning of the unit.
For disinfection of the unit, spray the disinfection agent onto a piece of soft cloth /
cotton and clean the handpiece and power adapter.
Do not use abrasives or solvents as these may damage the plastic parts of the unit!
Do not spray directly onto handpiece or in button / charge socket!

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VIII. WARRANTY CONDITIONS
1. Warranty period of BLUEDENT dental curing light is 24 (twenty four) months from
the date of purchase. If date of purchase is not written, warranty starts at date of
production.
2. During the warranty period the replacement of the defective parts is done free of
charge by manufacturer's service. Lightguide is not covered by warranty. LED module
and battery have 6 months warranty.
3. If during the guarantee period the unit is damaged, due to incorrect operation
(mechanical, chemical, thermal or electrical damages), damage caused by improper
use, storage or any other reasons in user's fault, the repair is paid by the user.
If any damage is noticed on electric cables, the device must be brought immediately
to manufacturer's service. The device must not be used if cables are damaged.
3.1 If liquids, aggressive and flammable substances and their vapors have entered the
device, the battery must be removed immediately and sent to the manufacturer’s
service where the damages are established. In case of such damage, the warranty is
lost.
3.2 No damages or complaints are accepted as a result of electric shocks,
thunderstorms, non-compliance with electrical safety measures or insufficient
protection of patients, personnel and other persons from light radiation.
3.3 Claims due to improper or insufficient security and care, protection and security
during transport, unpacking, relocation, operation and storage of the device are not
accepted. The warranty is void for the above events.
3.4 The device must only be transported to manufacturer’s service only in original
packaging in order to avoid unwanted damage. The light guide must be packed
separately from the cordless handpiece. The warranty card must be presented (this
Guide, with completed Chapter XII BLUEDENT data) or a copy of the sales invoice
showing the serial number of the device.
3.5 When carrying out repairs by unauthorized persons outside the company service
or if non-original elements / parts are used, the user loses the right to free service.

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4. The manufacturer provides its customers once a year (and in case of a situation -
immediately) to check in the company service whether the performance of the
devices is within the acceptable limits.
5. The manufacturer does not owe compensation for lost profits in case of damage or
incompleteness operation of the device, whatever the cause.
6. In case of disputes in connection with the application and interpretation of this
Operating instruction manual, they will be decided by the court in Plovdiv, by virtue
of the current Bulgarian legislation.
7. The warranty service is performed in the company service at the address:
155, Vasil Aprilov blvd
4027 Plovdiv
Bulgaria
tel: [phone]
email: [email protected]
www.bglight.com

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IX. SERVICE DATA

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X. FAQ
Problem
Solution
Weak polymerization effect
It is necessary to clean the tip of the
fiberoptic lightguide with a non-metallic
object and to clean the adhered composite
or other with alcohol. If the result is poor -
send the device to the service.
There is no sound signal
Hold down the left MODE button for 5-6
seconds until a sound is heard and ON
appears on the display.
The display shows Oh, the fan is
running and the blue light
cannot be started
The appliance is overheated. Wait for it to
cool for 3-5 minutes.
The patient experiences
discomfort during the
polymerization process,
especially during a long
polymerization time of 20-
30sec
It is necessary to polymerize with short
cycles - 10sec or less, with short breaks of
1-3sec. The sensitivity is higher if the light
is close to the dental pulp and decreases
with each layer. PULSE mode can be used.
The power cord or AC adapter
is damaged
Send to the service.
Liquid entering the device
Send to the service.
After falling to the floor, the
device does not work properly
Send to the service.