BG Light BLUEDENT 12 BL Instruction Manual

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

BLUEDENT 12 BL
LED Bleaching unit
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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.

BLUEDENT 12 BL
LED Bleaching unit
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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.

BLUEDENT 12 BL
LED Bleaching unit
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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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LED Bleaching unit
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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