BG Light BLUEDENT SMART cordless Instruction Manual

OPERATING INSTRUCTIONS MANUAL
BLUEDENT SMART cordless
Dental curing light
Ref.#200-004(A)

BLUEDENT SMART cordless
Dental 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 it in the future.
CONTENTS:
I. UNIT DESCRIPTION AND FUNCTION
II. TECHNICAL DATA
III. COMPLETE SET
IV. SAFETY PRECAUTIONS
V. PREPARATION AND SEQUENCE OF OPERATION
VI. ROUTINE CARE AND MAINTENANCE
VII. WARRANTY CONDITIONS
VIII. SERVICE DATA
IX. SYMBOLS
X. FAQ
XI. DECLARATION OF CONFORMITY
XII. BLUEDENT DATA
I. UNIT DESCRIPTION AND FUNCTION
Dental curing light BLUEDENT SMART is 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 consists of Wireless handpiece and Charging station with adapter.
The device is produced in conformity with MDR (EU) 2017/745.

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Dental curing light
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II. TECHNICAL DATA
1. Operating voltage:
- Handpiece - 3.7V Li Ion battery (2600mAh capacity)
- Adapter –type SYS1381N-1209-W2E, 100-240V AC / 50-60Hz / 9V DC / 1.33A,
power consumption - 0.5A max
- Charging station - 9VDC, power consumption - 0.8A max
2. Dimensions (approx.)
- Charging station –length 180mm, width –130mm, height –66mm
- Cordless handpiece - diameter - 32mm; length (with lightguide) - 196mm
3. Weight (approx.):
- Charging station –560g
- Cordless handpiece (with lightguide) –245g
4. Polymerization modes –RAMP (R), PULSE (P), LONG (L), FAST (F).
5. Emitted light –blue, visible spectrum, 410-490 nm.
Light intensity - up to 1300 mW/sq.cm
Intensity is constant and not dependent on battery charge level.
Light source –2 band LED module with reflector optics.
6. Emitting time:
- 10 / 20 / 30sec / 1-9 min (±5%)
7. Audible signal every 10 sec / 1 min according to the selected mode.
Possibility to turn on / off the sound signal.
8. Working ability after fully charged battery - up to 4000sec.
- up to 400 cycles х 10 sec - up to 66 cycles х 1 min
- up to 200 cycles х 20 sec - up to 7 cycles х 9 min
- up to 130 cycles х 30 sec
9. Charge time - 6 hours for full charge and 4 hours to 80% charge.
10. Indication for charging, end of charge and low battery warning.
11. Digital display for the selected mode and countdown timer.
12. Built-in 4-level indicator for checking the light intensity (optional).
13. Micro fan cooling.
14. Fiberoptic lightguide (rotatable 360 degrees)
15. Working mode (1 min. work / 10 min. pause)
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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Dental curing light
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III. COMPLETE SET
1. Cordless handpiece –1 pc.
2. Charging station - 1 pc.
3. Light intensity check
(option)
4. Start / Stop button
5. Charge adapter –1 pc.
6. Lightguide –1 pc.
7. Protection shield - 1 pc.
Protection cap.
8. Cooling fan
9. Operations guide - 1 pc.
IV. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLUEDENT is a Class I 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 device must not be covered, the cooling openings must not be closed so as not
to cause the device to overheat and ignite.

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Dental curing light
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- 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!
- Before each patient, the emitting window must be disinfected (with a disinfectant).
- 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 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;

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Dental curing light
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- 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.
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, 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. 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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Dental curing light
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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.
V. PREPARATION AND SEQUENCE OF OPERATION
BLUEDENT SMART is designed for use as a wireless stand-alone device.
1. Remove the appliance from its packaging. The
charging station is placed on a stable horizontal surface.
The device is switched on in standby mode by pressing
the Start / Stop button once.
2. Connect the adapter to the mains and the socket - to
the charging station.
The ON indicator lights up on the charging station. When
the cordless handpiece is inserted in the charging socket,
the CHARGE indicator also lights up.

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Dental curing light
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3. Mount lightguide and protection shield or protection cap.
See VI. 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.
(1)
For polymerization of posterior teeth
(attach as shown)
(1) Protection cap
For polymerization of anterior teeth /
general application
After fully charging the device or at the end of the day, disconnect the charging
adapter from the mains.
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.

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Dental curing light
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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.
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.)

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Dental curing light
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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.
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. Light intensity indicator (option)
The light intensity can be checked with the indicator built into the
BLUEDENT SMART charging base. Carry the probe so that the light
guide is centered in the sensor and start the device.
The number of illuminating points indicates the measured light
intensity:
- 4 - 100%; - 3 - 80%; - 2 - 60%; - 1 - 40%;
The different modes must be:
R - RAMP - 1,2,3,4 successively increasing illuminating points.
L - LONG - 4 light points.

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Dental curing light
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F - FAST - 4 light points.
P - PULSE - 3 and 4 alternating illumination points.
We recommend that the light intensity be measured in FAST mode. If the light
intensity is below 80% (less than 3 LEDs are lit), it is necessary to check the fiber for
stuck photocomposite material or mechanical defects.
12."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.
13. 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.
VI. 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.

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Dental curing light
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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!
3.MAINTENANCE, CHARGING AND REPLACING THE BATTERY
The charging station can be used as a stand and only when the battery is discharged,
the charging adapter can be switched on.
- After polymerization - place the handpiece on the charging base.
- If the battery is discharged to 5-10%, the display starts flashing, which means the
battery is almost discharged. If operation continues, the battery is completely
depleted after a few cycles - “Lb” (Low Battery) appears on the display. In this case,
place the handpiece on the charging station - The CHARGE indicator lights up. While
charging, the display of the handpiece shows 3 consecutive illuminated lines. When
the battery is fully charged, a long beep sounds for 30 seconds. The three lines are lit.
The probe then enters sleep mode.

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Dental curing light
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Lines movement
Battery charging
Fully charged battery
Indication is lit for
30sec
Timer flashes
low battery
5-10% charge!
Low battery
Put handpiece to
charge!
Use only original BLUEDENT SMART Li-Ion batteries with factory label (h 65 mm,
dia.18 mm), 3.7 V, TYPE 18650 - 2600 mAh.
- To replace the Li-Ion battery: Unscrew the bottom cover of the handpiece and
carefully remove the contact board, remove the plug and pull out the battery, slightly
taking apart the plastic shells of the probe. The installation of a new battery is done
in the reverse order.
The contact surfaces for charging the wireless
probe and the charging station should be
cleaned periodically with a cotton cloth soaked
in alcohol.
No chargers other than the supplied adapter - SYS1381N-1209-W2E - must be used to
charge the BLUEDENT SMART battery.
- The battery must not be: electrically shortened or mechanically damaged, become
wet, immersed in water or other liquids, heated or thrown into a fire.
- If there is a leak, odour or smoke from the battery - remove it from the appliance
using gloves and a mask and dispose of it according to local legislation.
- When disposing of an old battery, observe the rules of environmental protection!

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Dental curing light
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VII. 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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Dental curing light
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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: [e-mail]
www.bglight.com
VIII. SERVICE DATA

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Dental curing light
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IX. SYMBOLS
Manufacturer
BG LIGHT LTD, 155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria
Pursuant to Directive 2012/19/EU, this symbols shows that the product must
not be disposed of as urban waste at the end of its operating life.
Pay attention to the instructions accompanied by this symbol.
Fragile!
Product with CE mark.
Applied part type BF according to the classification for electrical safety
Ω
Ohm (electric resistance unit)
s
Second (time unit)
W
Watt (power unit)
Hz
Hertz (frequency unit)
mm
Millimeter (length unit)
A
Amper (electric current unit)
V
Volt (electric voltage unit)
Pa
Pascal (atmosphere pressure unit)
°C
Degrees Centigrade (temperature unit)
g
Gram (weight unit)
SN
Serial number
LOT
Lot

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Dental curing light
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X. FAQ
Problem
Solution
There is no indication “ON” on
the charging station
Check the adapter, cable and whether it is
plugged into the charging station. Check
for metal objects on the contact system of
the charging station.
Rapid battery drain
The battery needs to be replaced.
There is no charge indication of
the handpiece
If there is an “ON” indication on the
charging station - clean all contact surfaces
of the station and the handle. If "CHARGE"
does not appear - replace the battery or
send for service.
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.

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Dental curing light
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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.

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Dental curing light
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XI. DECLARATION OF CONFORMITY
Bulgaria, 4027 Plovdiv
155, Vasil Aprilov blvd.
[e-mail]
Declaration of conformity
ТД 7.2
Revision 02
Manufacturer: BG LIGHT LTD
Address: 155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria
Tel.: [phone], Fax: [phone]
BULSTAT 115841960, VAT N: BG 115841960
Product: BLUEDENT SMART –LED curing light
Basic UDI: 3800501374200000VX
Classification: Active device of Class I 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
13, Annex VIII.
Notified body: TUV NORD Polska Sp. z o.o., ul.Mickiewicza 29, 40-085 Katowice, Poland.
This Declaration of conformity is valid only in combination with our certificates of Notified body TUV NORD Polska Sp.
z o.o. Certificates N: AC090 100/1971/4047/2020, AC090 MD/1971/4047/2020, TNP/MDD/0334/4047/2020.
The manufacturer declares under its sole responsibility that the products are developed and produced in conformity
with Regulation on medical devices - MDR (EU) 2017/745 and the following applicable standards:
EN 60601-1:2006
+AC:2010+A1:2013+A12:2014
Medical electrical equipment - Part 1: General requirements for safety.
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements
and tests.
EN 62304:2018
Medical device software. Software life cycle processes.
EN 62353:2015
Medical electrical equipment. Recurrent test and test after repair of medical electrical
equipment.
EN 62366-1:2015+AC:2016
Medical devices. Application of usability engineering to medical devices.
EN ISO 14155:2011+AC:2011
Clinical investigation of medical devices for human subjects. Good clinical practice.
EN ISO 14971:2019
Medical devices –Application of risk management to medical devices.
CEN ISO/TR 24971:2020
Medical devices - Guidance on the application of ISO 14971.
EN ISO 15223-1:2016
Medical devices -- Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements.
EN ISO 20417:2021
Medical devices —Information to be supplied by the manufacturer.
EN ISO 10993-1:2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process.
ZMI
Закон за медицинските иделия на РБългария (от 31.05.2015)
ISO 9001:2015
Quality management systems –Requirements.
ISO 13485:2016
Medical devices. Quality management systems. Requirements for regulatory purposes.
Directive 2012/19/EC
Directive on waste electrical and electronic equipment (WEEE).
All company products are manufactured under the current Quality Management System, ISO 9001 and ISO 13485.
Dipl. Eng. Plamen Karaivanov 01.09.2021
Manager Plovdiv, Bulgaria
BG LIGHT LTD

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Dental curing light
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XII. BLUEDENT DATA
SN:
LOT:
DATE OF
PRODUCTION:
QC:
DATE OF PURCHASE:
Last revision: 01.09.2021
Follow www.bglight.com for updated revision of this Operating instructions manual.