BG Light BLUEDENT XPRESS-R cordless Instruction Manual

OPERATING INSTRUCTIONS MANUAL
BLUEDENT XPRESS-R cordless
Dental LED curing light
Ref.#200-009R

BLUEDENT XPRESS-R cordless
LED curing light
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BLUEDENT XPRESS-R cordless
LED 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 in the future.
CONTENTS:
I. UNIT DESCRIPTION AND FUNCTION
II. SYMBOLS
III. SAFETY PRECAUTIONS
IV. TECHNICAL DATA
V. COMPLETE SET
VI. PREPARATION AND SEQUENCE OF OPERATION
VII. ROUTINE CARE AND MAINTENANCE
VIII. WARRANTY CONDITIONS
IX. SERVICE DATA
X. FAQ
XI. DECLARATION OF CONFORMITY
XII. BLUEDENT DATA
I. UNIT DESCRIPTION AND FUNCTION
Dental LED curing light BLUEDENT XPRESS-R is an accessory to 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-R consists of Wireless handpiece with stand and Charging adapter.
BLUEDENT XPRESS-R is manufactured in conformity with the requirements of
Regulation on medical devices MDR 2017/745 and standards ISO 13485:2016, ISO
9001:2015.

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LED curing light
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II. SYMBOLS
Caution!
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a variety of
reasons, be presented on the medical device itself.
Consult instructions for use
Indicates the need for the user to consult the instructions for use.
Dangerous voltage
To indicate hazards arising dangerous voltage.
Hazardous light emission
To indicate hazards arising from light radiation.
Hazardous thermal effects
To indicate hazards arising from thermal effects.
Manufacturer
Indicates the medical device manufacturer.
Date of manufacture
Indicates the date when the medical device was manufactured
Medical Device
Indicates the item is a medical device
Unique Device Identifier
Indicates a carrier that contains Unique Device Identifier information
Catalogue number
Indicates the manufacturer's catalogue number so that the medical device can be
identified.

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LED curing light
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Serial number
Indicates the manufacturer's serial number so that a specific medical device can be
identified.
Batch code
Indicates the manufacturer's batch code so that the batch or lot can be identified.
Applied part type B according to electric safety classification
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Waste Electrical and Electronic Equipment (WEEE)
According to Directive 2012/19/EU, this symbol indicates that the product
should not be disposed of as urban waste at the end of its operating life.
Fragile
Indicates a medical device that can be broken or damaged if not handled carefully.
European Conformity
Indicates conformity with local laws and regulations within the European Economic Area

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LED curing light
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III. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLUEDENT is a Class I accessory to a 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 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!
- Fragile! Use caution when transporting, using and storing the device!
- 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!

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LED curing light
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- In accordance with the requirements of MDR (EU) 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. Use only the original adapter type
SYS1638-0605-W2E.
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;
- 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.

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LED curing light
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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.
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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LED 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.

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LED curing light
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IV. TECHNICAL DATA
1. Operating voltage - 3.7V Li Ion battery type LIR 14500 (800mAh capacity)
2. Charge adaptor: SYS1638-0605-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
- Diameter of handpiece –min.18mm / max.25mm
- Length - 215 mm
4. Weight of cordless handpiece –156g
5. Polymerization modes –RAMP (R) –with soft start
6. Light source –2 band LED module with reflector optics.
7. Emitted light –blue, visible spectrum, 410-490 nm
8. Light intensity - up to 2100 mW/sq.cm with gradual increase of intensity
Intensity is constant and not dependent on battery charge level.
9. Emitting time - 10 / 20 / 30 sec. /±10%
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
11. Working ability after fully charged battery - up to 2100sec (210 cycles x 10 sec)
12. Charge time –3 hours for full charge and 2 hours to 80% charge.
13. Low battery warning. Fully discharged battery indication.
14. Working mode (1 min. work / 10 min. pause)
15. Degree of protection against electric current - applied part type B.
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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LED curing light
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V. 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
VI. PREPARATION AND SEQUENCE OF OPERATION
BLUEDENT XPRESS-R 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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LED curing light
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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. 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. Indication
5.1. Color indication ring
Deactivated mode - Color indication ring is
not lit.
Work mode –polymerization.
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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LED curing light
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5.2 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.
6. Choosing timer mode:
-SINGLE Press the Start / Stop button - 10 sec.
-DOUBLE Press the Start / Stop button - 20 sec.
-TRIPLE Press the Start / Stop button - 30 sec.
After the set time has elapsed, the unit will turn off the output light.
If desired, the dentist can interrupt the cycle by pressing the Start / Stop button
again.
7. During operation, the handpiece tip must be at a distance of at least 2 mm from
the obturation.
Intensity
Diagram of curing mode –RAMP
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 10/20/30 seconds.
9. The curing light is switched off at the end of the day after the adapter is
disconnected from the mains (if it is charging).

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LED curing light
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10. Overheating protection
The unit is equipped with overheating protection, which is activated if the
temperature of the LED module rises up to 50°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 device’s
cooling down.
11. Battery –maintenance, charging and replacement
The device uses Li-Ion battery type LIR 14500 / 3,7V / 800 mAh.
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 SYS1638-0605-W2E - 100-240VAC input and 5VDC output - micro
USB type. It is not allowed to use another type power supply.
Low Battery indication:
- 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 2100 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.

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LED curing light
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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 by the device manufacturer (LIR 14500 / 3,7V /
800 mAh)!
(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!

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

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LED curing light
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VIII. 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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LED 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

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LED curing light
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IX. SERVICE DATA

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X. FAQ
Problem
Solution
No response by button starting
Fully discharged battery. Need to connect to
charger to begin charge. Use only the
original adapter type SYS1638-0605-W2E. 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.
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
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