BG Light BLUEDENT XPRESS cordless Instruction Manual

OPERATING INSTRUCTIONS MANUAL
BLUEDENT XPRESS cordless
Dental curing light
Ref.#200-009(ort)

BLUEDENT XPRESS 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 XPRESS 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 XPRESS consists of Wireless handpiece with stand and Charging 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 - 3.7V Li Ion battery 2600mAh capacity)
2. Charge adaptor: SYS1421-0605-W2E
- 110-240VAC / 50-60Hz input voltage
- Output: 5V DC / 1.2A micro USB socket
- 0.5 A max power consumption
3. Dimensions of cordless handpiece:
- Head of emitting handpiece –14 x 16 mm, max diameter of handpiece - 30mm,
length - 215 mm
4. Weight of cordless handpiece –165g
5. Polymerization modes –RAMP (R), HYPER (H)
6. Emitted light –blue, visible spectrum, 410-490 nm
7. Light intensity:
- RAMP mode –up to 1500 mW/sq.cm with gradual increase of intensity
- HYPER mode –up to 3500 mW/sq.cm with immediate increase of intensity
Intensity is constant and not dependent on battery charge level.
8. Light source –2 band LED module with reflector optics.
9. Emitting time:
- RAMP mode - 10 / 20 sec. /±10%
- HYPER mode - 3/3+3* sec. /±10% - with 1sec pause
- HYPER ORTHO mode - 3/36*sec/±10% - with 2 sec pause –for ORTHO program
With the Start / Stop button it is possible to stop the device at any time.
10. Visual indication - color indication ring and audible signal every 10 sec / 3 sec
depending on chosen work mode.
11. Working ability after fully charged battery - up to 4000sec (in RAMP mode):
- up to 400 cycles x 10 sec
- up to 200 cycles x 20 sec
12. Charge time –6-7 hours for full charge and 3-4 hours to 80% charge.
13. Low battery warning. Fully discharged battery indication.
14. 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. Charge adaptor with micro USB
output 5V DC / 1.2A - 1 pc.
2. Cordless handpiece - 1 pc.
3. Battery pack - 1 pc.
4. Barrier sleeves - 50 pc.
5. Holder - 1 pc.
6. Operations guide - 1 pc.
Control and indication:
1. USB charging connector
2. Start / Stop button
3. Illuminated indicator ring
4. Battery pack
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).

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Dental curing light
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- The device 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!
- 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;

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Dental curing light
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- 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.
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.

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Dental curing light
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Risk of pain, burning of soft tissues.
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 XPRESS is designed for use as a battery powered unit.
1. Take the curing light out of the packing and assemble the holder by inserting the
upper part into the base part (as shown on picture below). Place the holder on a
horizontal surface.
2. Connect the power adapter to charge
battery if needed.

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The device can be operated during charging.
After fully charging the device or at the end of the day, unplug the charging adapter.
3. A new barrier sleeve is placed on the front of the probe before each patient. It is
for single use only and is marked with the appropriate sign.
4. BLUEDENT XPRESS has 2 work modes.
They are indicated according to the color
of the illuminated ring on the handle:
GREEN - RAMP mode.
RED color - HYPER mode.
BLUE color - change mode or beep.
The device wakes up by pressing the Start / Stop button once. Select the desired
operating mode by pressing and holding (2 sec.) The Start / Stop button.
The device has a smooth start (slow increase in light intensity) in RAMP mode to
reduce the stress of the photocomposite.
5. The curing light is activated by briefly pressing the Start / Stop button on the
handpiece.
Choice of time:
In RAMP mode:
- with a single press (1x) - 10 sec.
- when pressed twice (2x) - 20 sec.
In HYPER mode:
- with a single press (1x) - 3 sec.
- when pressed twice (2x) - 3 + 3 sec.
After activating the button, blue light appears.

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Dental curing light
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In HYPER mode, after each cycle 3/3 + 3 sec., there is a 3 sec pause which is a
protective time against overheating of the dental pulp. The light ring flashes and the
device cannot be activated.
In the ORTHO version there is a difference only in the HYPER mode:
- with a single press (1x) - 3 sec.
- when pressed twice (2x) - 12 times for 3 seconds with a pause of 1 second between
lights.
3. Indication
3.1. Color indication ring
Deactivated mode -
Color indication ring is not lit.
RAMP mode
HYPER mode
Protection pause in HYPER mode
Battery charge / sound signal.
Fully charged battery –device can be
unplugged from adapter.
Overheating –Thermal protection activated,
wait until device cools down.
Battery is completely discharged - plug into
the charging adapter.

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Dental curing light
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- LED module
LED module indication:
Blinking means that the battery is discharged -
there is only 20% charge left, you have the
option of 5-25 starts of 10 seconds to full
discharge.
7. The handpiece is directed to the place designated for irradiation, as the tip of the
device is brought as close as possible to the object of irradiation / 4 to 7 mm /, and
after a few seconds. can also be irradiated by contact.
8. Stop the curing light at any time by pressing the Start / Stop button again.
If device is not stopped preliminary, it will stop after preselcted 10/20 or 3/3 + 3
seconds.
9. The curing light is switched off at the end of the day after the adapter is
disconnected from the mains.
10. Overheating protection
The unit is equipped with overheating protection, which is activated if the
temperature of the LED module rises up to 40-45°C. When overheating protection is
activated the color ring will blink in yellow next 60sec, then is deactivated until the
temperature of the handpiece reaches 35°C. It is necessary to wait for the device to
cool down.
6. Battery –maintenance, charging and replacement
Charging the battery - by connecting the charging adapter to the mains.
Attention! Connect properly to the socket!
Unplug the adapter after charging.
Charge adaptor is SYS1421-0605-W2E - 100-240VAC input and 5VDC output - micro
USB type. It is not allowed to use another type power supply.
Low Battery indication:

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Dental curing light
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- rare flashes of the output light from the lightguide - when 5-10% of the charge
remains of the battery. Only a few cycles (5-10) remain until complete discharge. It
can be used for polymerization as the intensity is stabilized.
- With a fully discharged battery, the color ring will flash blue only a few times.
When charging - the light ring flashes slowly in blue, and when the battery is 100%
charged - it lights up continuously . Even if it remains switched on for charging for a
longer period of time, there is no danger of overcharging or battery damage. After a
full charge, the battery provides up to 4000 seconds work.
It is possible to work with the device during charging.
Monitor the battery charge and recharge if a low level is indicated.
Unplug the charger after charging the device or at the end of the day.
When to replace the battery:
- at reduced capacity - frequent charging is required;
- in case of battery failure.
To replace a Li-Ion battery:
- Disconnect the adapter from the socket and the USB socket.
- Place the handpiece on a non-slip surface and unscrew Part 3. Release Part 2.
Carefully remove the connector (4).
- The installation of a new battery is done in the reverse order.
- When assembling the handpiece - place Part 2 (containing the battery) on a non-slip
surface and press Part 1 to Part 2 at the same time. At the same time, screw the
cylindrical Part 3 back to the front conical Part 1.
Note: The parts of the assembly between 1 and 2 must fit!
Do not twist the battery cables!
Use only original Li-Ion batteries!

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Dental curing light
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(4)
The battery must not be short circuited, mechanically damaged, immersed in water
or to be heated or thrown into a fire.
- Non-functioning batteries can be taken to battery collection points or returned to
the device manufacturer.
- When disposing of the battery, observe the environmental protection regulations!
VI. ROUTINE CARE AND MAINTENANCE
1. Cleaning the emitting tip
Clean the emitter glass daily with an alcohol
swab dipped in alcohol. Adhesive
photocomposite is not allowed - if there is one, it
should be carefully removed with a blunt, non-
metallic object.
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 / USB charge connector!

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Dental curing light
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To avoid cross-contamination, it is mandatory to use disposable barrier sleeeve on
the handpiece, new one for each patient.
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.

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Dental curing light
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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.
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

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Dental curing light
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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
No response by button starting
Fully discharged battery. Need to connect to
charger to begin charge. If button continues
not to respond - send the device to service.
The button does not respond
properly
When working without barrier sleeves, the
problem with the button may be the entry
of composite, adhesive or disinfectant liquid
when the device is used without protective
nylons. You need to clean with a cotton
swab soaked in alcohol. If the button still
does not respond correctly - send the device
to service.
Does not allow starting in HYPER
mode, the ring flashes red.
In this mode there is a 3sec protection time
during which the device cannot be started in
order to prevent soft tissue overheating.
Meaning of INDICATION ring
colors:
green - RAMP mode - 1500mW/cm2
red –HYPER mode 3500mW/sq.cm
red blinking –protection pause
blue continuously - 100% charged battery
slow blinking blue - in charging mode
quick blinking blue 2sec - fully discharged
battery
yellow - LED module overheating
Slow blinking of blue light of main
LED
This is indicator that battery will allow only
5-10 cycles before full discharge. Need
urgent charge.
Weak curing effect
It is necessary to clean the emitting tip with
a non-metallic object and to clean the
adhered composite or other with alcohol. If

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Dental curing light
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the result is poor - send the device to the
service.
The patient feels discomfort during
curing process especially during
long curing time 20-30sec
Need to cure at short cycles 10sec or less
with short pauses 1-3sec. Sensibility is
higher if light is near dental pulp and is
decreased by every layer. Use RAMP mode.
Power cord or mains adaptor is
damaged
Send to service.
Entering some liquid into device
Send to service.
After drop on the floor device is
not working properly
Send to 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
TD 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 XPRESS –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.