BG Light BLUEDENT 12 BL Instruction Manual

OPERATING INSTRUCTIONS MANUAL
BLUEDENT 12 BL
Dental bleaching unit
Ref.#600-001

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Caution! Before installing and operating with the unit, read carefully this manual!
I. UNIT DESCRIPTION AND FUNCTIONS
II. TECHNICAL SPECIFICATIONS
III. PACKAGING / COMPONENTS
IV. SAFETY PRECAUTIONS
V. INSTALLATION
VI. PREPARATION FOR OPERATION
VII. DAILY CARE AND MAINTENANCE
VIII. PREPARATION FOR WORK WITH PATIENTS
IX. POSITIONS OF BLEACHING HEAD AGAINST PATIENT'S TEETH
X. DETERMINATION OF DISTANCE TO PATIENT'S TEETH
XI. PROBLEMS AND SOLUTIONS
XII. WARRANTY
XIII. SYMBOLS
XIV. SERVICE DATA
XV. DECLARATION OF CONFORMITY
XVI LED BLEACHUNG UNIT DATA
I.UNIT DESCRIPTION AND FUNCTIONS
BLUEDENT 12 BL LED bleaching device is a medical device designed to whiten the solid
tooth tissue by photoactivation of a whitening gel used in dentistry (6-39% hydrogen or
carbamide peroxide).
The appliance should only be used by a qualified dentist and in a dental practice.
The device consists of a Bleaching Head, Stand and a Power Adapter.
BLUEDENT 12 BL is manufactured in conformity with the requirements of standards ISO
9001:2015, ISO 13485:2016 and Medical Devices Directive 93/42/EEC.

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II. TECHNICAL SPECIFICATIONS
1. Operating voltage to the power adapter - 100-240V / 50-60Hz, to the whitening head
- 24VDC.
2. Current consumption - 0.4-0.2 A
3. Dimensions:
- Bleaching head
length - 220 mm
width - 155 mm
height - 95 mm
- Stand
length (assembled) - 1300 mm
4. Weight:
- Bleaching head - 640 g
- Stand - 8500 g
5. Irradiance - HI mode (100%), LO mode (50%) measured at the output window
6. Operation time - 10 sec. - 30 min / ± 5% /
7. Emitted light - blue 430 - 490 nm.
8. Light source - 10 LED modules x 5W = 50W
9. Fan air cooling.
10. Ability to start and stop the Bleaching Head at any time.
11. Maximum continuous operation time 99 min –every 99 minutes of continuous
operation should have at least 10 minutes rest.
The manufacturer of this device will provide upon request the necessary additional technical
documentation / information necessary for the technical staff of the user to repair those parts of the
device that the manufacturer has specified as subject to repair.

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III. PACKAGING / COMPONENTS
1. Power cord
2. Power Adapter 100-240VAC
/ 24VDC
3. Horizontal arm
4. Central fixator locking
mechanism
5. Front fixator locking
mechanism
6. Base with 5 wheels
7. Vertical arm
8. Bleaching head
9. Counterweight
10. Control panel
10A. "+" Timer or "Pause"
button
10B. "-" Timer or "Pause"
button
10C. Start / Stop button
10D. Display
11.Emitting window of
bleaching head
12. Cables and connectors
13. Safety glasses - 2 pcs.
The device should only be moved when all 5 wheels are attached to the Base (6). Each
wheel has a locking mechanism.
Positioning of the horizontal arm is done by the Central fixator locking mechanism (4).
Fine positioning is done by turning the Bleaching head so that the light is perpendicular
to the patient’s teeth and centered on them.
If the movement of the Bleaching head is difficult or it does not hold the selected
position it is necessary to adjust the Front fixator locking mechanism (5).

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IV. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLUEDENT 12 BL is a Class IIa 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 12 BL 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!
- Before each patient, the emitting window must be disinfected (with a disinfectant).
- Before the patient undergoes whitening, he/she must sign an Informed Consent, which
describes in great detail the possible side effects of the process. Sample text can be
found at www.bglight.com

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- Note: It is recommended to attend a suitable training "Teeth whitening in a dental
office"!
- Fragile! Use caution when transporting, using and storing the device! When
transported in an assembled condition, two persons are required to keep the moving
parts. With any unevenness on the flooring, the device should only be moved by two
people.
- 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!
- In accordance with the requirements of MDR 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 12 BL 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!

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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.
2. Light radiation
BLUEDENT 12 BL 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, and for the patient goggles, mask and
high-factor sunscreen.
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. 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.

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- 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.
4. Danger of mechanical moving parts
- To be used in rooms with a horizontal floor surface.
- Assemble the mechanical parts, position them, lock them slowly with care.
- The device must not be used for transporting or moving people or objects.
- The counterweight must be fully screwed in order to avoid falling and injuring people
and objects.
- Fix the emitting head well - at an appropriate height and distance to be stable in front
of the patient's teeth during the procedure.
- Do not turn the horizontal arm by force to avoid mechanical shocks with the
counterweight or the bleaching head. In the event of a mechanical shock, if the
whitening head is damaged, the use of the device must not be continued. It must be
taken immediately to the company service center.
- To take measures against damage to the human body by mechanical parts (movable
and immovable), pinching, inertial reinforcement of the counterweight, manipulations
with the device to be performed carefully to avoid injury.
- The movement of the parts of the device without prior unscrewing of the fixators can
damage their locking mechanism. The wheel stoppers, if any, must be released before
moving the bleach.
Risk of mechanical damage to the operator and the patient.
5. Who should not be bleached because of prohibitions and risk of burns and
complications:
- The device should not be used by: pregnant and breastfeeding mothers; patients with
severe periodontal pathology, with recessions, dental hyperesthesias and under 17
years of age; patients with allergies, wounds and infections, fresh scars on the face, skin
infections, recently placed dental implants or surgical procedures in the oral cavity and
face, fibral conditions, herpes, bleeding, bruises, burns, cancer or indications of such on
the face and lips cavity, atypical warts in the area of irradiation, difficult to heal wounds;
patients taking painkillers that dull the skin's sensitivity to heat; persons under the
influence of alcohol or narcotics.
- 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

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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 and never undergo bleaching procedure if it is indicated that it
may cause photoallergic reactions, or if you are required to avoid sun exposure after
taking this medicine.
Failure to follow the whitening protocol may result in pain, hypersensitivity, enamel
damage, and soft tissue burns.
6. What to do before bleaching:
- Talk to the patient to clarify the patient's status and explain the prohibitions and risks
and to answer any questions.
- Familiarization of the patient with the content of the "Informed Consent" and its
mandatory signing by the patient.
- Isolation of soft tissues with a mask to avoid burns and skin reactions.
- Mandatory use of the safety goggles provided by the manufacturer for the operator
and the patient. Do not use other types of glasses that may be dangerous to the eyes.
- Check the patient's sensitivity to light intensity. The device has 2 levels of intensity and
with the distance to the teeth the optimal conditions are selected.
Testing begins with a high level of intensity "Hi" (High) and a distance of 5-6 cm and if
the heat sensation after 1-2 minutes is very strong, the distance should be increased to
achieve an acceptable thermal sensation.
If the heat sensation is very strong at 10-15 cm, then it is better to switch to low
intensity - "Lo" (Low) and less distance to the teeth.
If the patient has no sensitivity or cannot judge the distance –it is advisable to work at a
greater distance and mode "Lo".
- After selecting the appropriate intensity (HI or LO) and the distance between the
device and the patient's lips between 5 and 15 cm, dentist must monitor how the
patient reacts to this intensity - for example after a few minutes of irradiation. Distance
should be adjusted according to the patient heat response to avoid danger of side
effects - burns. The heat effect is as strong as the light effect. For example, in the
summer or at high temperatures in the room, it is mandatory to increase the distance to
the patient by 1-2 cm.
- To have constant control over the procedure to ensure that the distance has not
changed. The patient should not be left unattended during the procedure.
- It is desirable to have a picture before and after the procedure of the teeth and soft
tissues and to monitor whether there is redness or other reaction. The photo should be
stored long enough to monitor the effect of whitening and possibly the soft tissue
reaction.

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7. What to do after bleaching:
- Examination of the patient after the procedure for redness and changes in the mucosa,
if any, to give him a prescription for appropriate treatment and to keep in touch with
him in the coming days until the disappearance of any problem. It is desirable for the
dentist to keep in touch with a dermatologist and to be able to offer a consultation with
one in case of problems with the patient.
- The patient should be warned to observe the necessary hygiene and not to undertake
self-medication, which may deepen the reaction and to maintain contact with the
dentist if necessary.
- The clinic (dentist) takes full responsibility for quickly and effectively solving any
problems in order to ultimately obtain the desired aesthetic result without unwanted
complications and consequences.
V. INSTALLATION
BLUEDENT 12 BL is intended for use as an autonomous appliance. Use the device
indoors and only on a horizontal surface.
1. Unpack the transport boxes, remove the components and initially assemble the
base with the 5 wheels.
2. Mount the vertical arm to the center of the base.

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3. Mount the horizontal arm of the stand
and fix it with the side stop screw using a
3 mm Allen key (included in the
package).
Fixing of side stop screw.
4. Place the counterweight at the rear of
the horizontal arm by rotating it
clockwise.
It is important to mount the
counterweight securely on the arm!
5. Mount the bleaching head at the front of the horizontal arm in the following order:
- The front fixing ball is
tightened firmly to fix the
bleaching head.

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- The bleaching head is
wound on the metal stick
until it stops completely.
- The fixing ball is loosened
to adjust the bleaching head.
- After adjusting the position
of the bleaching head to the
desired position, tighten the
fixing ball.
6. The horizontal arm allows movement
in vertical direction.
The central fixing ball locks the
horizontal arm and the bleaching head
into a suitable position.
7. Connect the cables using the
connectors (see figure).
The device will not work if the cable
connectors are incorrectly coupled.

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8. All moving parts are inspected, for omissions.
9. Plug the power cord into the adapter.
10. Plug the power cord into the power network, SHUKO socket.
VI. PREPARATION FOR OPERATION
1.The BLUEDENT 12 BL bleaching device should be placed in a suitable position around
the patient and the dental unit. See the positioning examples (Section IX).
The bleaching head must be in the same vertical plane and parallel with the arc of the
teeth with a distance between 5-15 cm. See the positioning examples (Section IX).

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2. Plug the power adapter into the power network. Only one point/dot on
the display lights up. Press START / STOP button and then the "Hi" (High)
or "Lo" (Low) intensity indication appears.
3. The display shows "HI" - a high intensity level. If you want to switch to
the "Lo" (Low) intensity mode, press the TIMER / MODE (+ / -) button
once. Then the display will show "Lo". Every time before setting the
required time, you will be able to select the Hi or Lo intensity level.
4. Press the START / STOP button once again and set time option will be
displayed. Note that the device will save the timeframe used in the latest
bleaching procedure. Required time frame for operation is set by pressing
TIMER + (increasing time) and TIMER- (reducing time):
The display on the bleaching head will indicate timeframes between 10
sec. and 9 min. and 50 sec. with a dot between the two digits.
Examples:
Display indicates: 13. This means the timeframe is set to 13 min.
Display indicates: 0.1. This means the timeframe is set to 10 sec.
Display indicates: 9.5. This means the timeframe is set to 9 min. and 50
sec.
The display on the bleaching head will indicate timeframes between 10
min. and 30 min. without a dot between the two digits.
5. Press the START / STOP button one final time and the device will start to emit light. A
flashing dot on the display will indicate that the device is working properly.
6. If either of the TIMER / MODE (+ / -) buttons is pressed
during operation, the unit switches to Pause mode. A
blinking display with the remaining time will
indicate that the device is paused. Operation is
resumed by pressing any TIMER / MODE (+ / -)
button again.
7. To Stop the bleaching device at any time press the
START / STOP button. If the device is not manually stopped it will stop after the
selected time has elapsed. Note that the fan will continue to work for some time in
order to cool down the unit.

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8. At the end of the day turn off the device by holding down the Start / Stop button for
3-4 seconds or by disconnecting it from the power network.
9. In case of overheating the thermal protection is triggered and the
device will cease to emit light. The display will indicate "Oh" and the fans
will turn on for 1 minute. After cooling, the device will continue its normal operation,
but stays in Pause mode. Overheating can only happen in an emergency situation or by
accidental clogging of the cooling vents. For this reason the cooling vents located on the
bottom of the bleaching head must always be unobstructed in order to allow air
circulation.
VII. DAILY CARE AND MAINTENANCE
1. Disinfection of the PVC window of the bleaching head
For each patient, the emitting window is cleaned with a cotton swab soaked in an
alcohol solution.
2. Cleaning the device:
To disinfect the device and its parts, spray disinfectant on a piece of soft cloth or cotton
and clean.
Do not use abrasives or solvents, as this may damage parts of the device!
VIII. PREPARATION FOR WORK WITH PATIENTS
1. Before starting work with the bleaching device, insulate the
patient’s non-calcified soft tissue, place a cover or protective
napkin on the face, apply protective UV cream and put on
protective glasses. Bleaching gel is applied to the teeth surface
according to the directions for use outlined by the gel
manufacturer.
The patient should be under constant supervision by the dentist during the bleaching
process in order to avoid discomfort and to ensure all safety and technological
procedures are applied.

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2. It is desirable to check the individual sensitivity of the patient. The device has two
levels of intensity (high HI and low LO) and the optimal conditions are selected by
adjusting the distance of the device to the patient's teeth.
Testing starts with a high intensity "Hi" and a distance of 5 cm and if the heat sensation
is very strong, the distance is increased to achieve an acceptable thermal sensation.
If the acceptable distance is more than 10 cm, it is better to switch to a mode with low
intensity - "Lo" (Low) and put the bleaching head closer to the teeth to obtain optimal
distance.
IX. POSITIONS OF BLEACHING HEAD AGAINST PATIENT'S TEETH

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X. DETERMINATION OF DISTANCE TO PATIENT'S TEETH

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XI. PROBLEMS AND SOLUTIONS
The device does not work.
Check if the power cord from the adapter is plugged into the power network and all
cable connectors are correctly coupled.
Damaged power cord.
Do not use the device! Switch it off and replace the cable with new one or take the
device to the service facility.
Unpleasant or irritating thermal sensation by the patient.
Increase the distance of the device to the patient’s teeth to 10-15 cm. If the thermal
sensation is still unpleasant at this distance switch to low intensity- "Lo" (Low) and
shorten the distance to the teeth.
The display is blinking and no light is emitted.
The device is in PAUSE mode. To resume operation, press either (+) or (–) TIMER
button.
The Bleaching Head cannot be fixed.
Tighten the fixing ball until the desired head position is reached (see Chapter V., point
5).
The display only shows "Oh".
The device has protection against overheating, and is activated if the temperature in the
emitting head rises. Then the light stops, the display shows "Oh" - Overheating - and the
fans work for 1 minute. After cooling, the device returns to normal operation.
Overheating can only occur in an emergency or when the cooling openings are blocked.
Therefore, the cooling openings in the lower part of the radiating head must always be
free for air circulation.
For all other questions regarding installation and operation of the BLUEDENT 12 BL,
contact the manufacturer or your local dealer.

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XII. WARRANTY
1. The warranty period of the BLUEDENT 12 BL bleaching device is 24 (twenty-four)
months from the date of purchase. If the purchase date is not filled in, the warranty
begins on the date of production.
2. During the warranty period, the replacement of the defective elements is carried out
free of charge by the manufacturer. Note - LED modules have a 6-month warranty.
3. The device and its components must only be used as intended by the manufacturer
purpose outlined in this Operating instruction. Any other use will void the warranty and
the manufacturer is not liable for any damages or damages caused by it.
4. If during the warranty period the device fails due to improper operation (mechanical,
chemical, thermal, electrical), non-intended use, inappropriate storage etc.., warranty
will be void and the repair cost will be at the expense of the user.
The device should not be used with damaged cables. If any such damages are noticed
switch off the device and immediately take it to the service facility.
If liquids such as water and solvents, aggressive or flammable substances and their
vapors, watering or wiping the device with them, insects or rodents enter the device,
the device must be taken immediately to the service facility. Damages from the above
will void the warranty.
No claims shall be accepted for damages arising from electrical shocks, thunderstorms,
non-compliance with electrotechnical safety measures or insufficient protection of
patients, staff, other people, animals, plants, and objects from light radiation.
The manufacturer does not owe any compensation for lost profits during the period
when the device is damaged or malfunctioned, no matter what the reason.
Claims for damages and claims due to of non-compliance with the bleaching procedure
are not accepted. Including but not limited to: shorter or longer time period use of the
device with the bleaching material set by the gel manufacturer; unsatisfactory bleaching
result; patient's harms from the bleaching material; overdosage; insufficient insulation
of patient’s non-calcified soft tissue; improper protection of the patient and staff;

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inappropriate, expired, intended for another wavelength and/or with unsuitable
concentration bleaching material.
The warranty is forfeited and no claims shall be accepted for damages as a result of
incorrect or insufficient care and attention for protection during transport, unpacking,
moving, handling and storage of the device.
In the event of disputes arising out of the application and interpretation of this
Operating Instructions Manual, those will be settled by the courts in the city of Plovdiv,
under the current Bulgarian legislation.
5. The warranty of the device will be forfeited if any repairs or modifications are done
by unauthorized personnel outside of the manufacturer’s service facilities and/or non-
original spare parts are used.
6. The manufacturer recommends that customers should check whether the device
parameters are within the permissible limits once a year. Technical condition tests and
verifications may only be carried out at the manufacturer’s service facilities or by an
authorized representative.
7. Sending for repair to the company service must be done in the original packaging of
the product.
8. All repairs must be done at the manufacturer’s service facilities with the following
address:
155, Vasil Aprilov blvd., 4027 Plovdiv, BULGARIA
tel.: [phone]
www.bglight.com
[email protected]