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Related Manuals for BG Light BLUEDENT 12 BL
Summary of Contents for BG Light BLUEDENT 12 BL
- Page 1 OPERATING INSTRUCTIONS MANUAL BLUEDENT 12 BL Dental bleaching unit Ref.#600-001...
- Page 2 DECLARATION OF CONFORMITY 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).
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Page 3: Technical Specifications
BLUEDENT 12 BL LED Bleaching unit 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... -
Page 4: Packaging / Components
BLUEDENT 12 BL LED Bleaching unit 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. -
Page 5: Safety Precautions
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. - Page 6 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;...
- Page 7 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.
- Page 8 BLUEDENT 12 BL LED Bleaching unit - 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.
- Page 9 BLUEDENT 12 BL LED Bleaching unit 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.
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Page 10: Installation
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. - Page 11 BLUEDENT 12 BL LED Bleaching unit 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.
- Page 12 BLUEDENT 12 BL LED Bleaching unit - 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.
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Page 13: Preparation For Operation
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). - Page 14 BLUEDENT 12 BL LED Bleaching unit 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"...
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Page 15: Daily Care And Maintenance
BLUEDENT 12 BL LED Bleaching unit 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. - Page 16 BLUEDENT 12 BL LED Bleaching unit 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.
- Page 17 BLUEDENT 12 BL LED Bleaching unit DETERMINATION OF DISTANCE TO PATIENT'S TEETH...
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Page 18: Problems And Solutions
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. -
Page 19: Warranty
LED Bleaching unit 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. - Page 20 BLUEDENT 12 BL LED Bleaching unit 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.
- Page 21 LED Bleaching unit XIII. SYMBOLS Manufacturer BG LIGHT LTD, 155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria Date of manufacture Pursuant to Directive 2012/19/EU, this symbol shows that the product must not be disposed of as urban waste at the end of its operating life.
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Page 22: Service Data
BLUEDENT 12 BL LED Bleaching unit XIV. SERVICE DATA... -
Page 23: Declaration Of Conformity
Manufacturer: BG LIGHT LTD Address: 155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria Tel.: +359 32 644089, +359 888 809256 BULSTAT 115841960, VAT N: BG115841960 2274 BLUEDENT 12 BL – bleaching unit Product: Product code: 600-001 Basic UDI: 3800501374600000XK Classification: Active device of Class IIa of the to Regulation on medical devices - MDR (EU) 2017/745 Classification is done by the manufacturer according to Regulation on medical devices - MDR (EU) 2017/745, Rule 9, Annex VIII. -
Page 24: Date Of Purchase
BLUEDENT 12 BL LED Bleaching unit XVI. LED BLEACHING UNIT DATA LOT: DATE OF PRODUCTION: DATE OF PURCHASE: Last revision: 01.09.2021 Please follow www.bglight.com to download the latest updated revision of this Operating instructions manual.
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