BLUEDENT 200-009 Smart Xpress Cordless LED Curing Light Instruction Manual

BLUEDENT 200-009 Smart Xpress Cordless LED Curing Light

BLUEDENT XPRESS Cordless Dental Curing Light

The BLUEDENT XPRESS cordless dental curing light is a 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 in a dental practice. It consists of a wireless handpiece with a stand and charging adapter.

Technical Data

• Operating voltage – 3.7V Li Ion battery 2600mAh capacity

• 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

• Dimensions of cordless handpiece: length – 215 mm

• Light intensity: Intensity is constant and not dependent on battery charge level.

• Emitting time: With the Start / Stop button, it is possible to stop the device at any time.

• Visual indication – color indication ring and audible signal
  every 10 sec / 3 sec depending on chosen work mode.

• 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

• Low battery warning. Fully discharged battery indication.

• Working mode (1 min. work / 10 min. pause)

Product Usage Instructions

Before using the BLUEDENT XPRESS cordless dental curing light, carefully read the operating instructions manual and save it for future reference. Here are the steps to use the product:

1. Charge the battery pack using the provided charge adapter.
2. Attach a barrier sleeve to the cordless handpiece.
3. Press the Start / Stop button to turn on the device.
4. Position the cordless handpiece close to the area that needs to be cured.
5. Keep the handpiece in position for the desired amount of time (up to 60 seconds).
6. Press the Start / Stop button again to turn off the device.
7. Remove the barrier sleeve from the cordless handpiece.

It is important to follow all safety precautions and routine care and maintenance instructions provided in the operating instructions manual. Failure to do so may result in damage to the device or injury to the user or patient.

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

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.

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.

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.

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

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.

• 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.

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;
• 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.

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.

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.

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.

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.

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. 2. Connect the power adapter to charge battery if needed. 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.

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.

Indication

Color indication ring 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.

• 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.

• 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.

• The curing light is switched off at the end of the day after the adapter is disconnected from the mains.

• 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.

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:

• 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!

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!

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.

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.

   • 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.
   • 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.
   • 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.
   • 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.
   • 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: +359 32 644089, +359 888 809256 email: office@bglight.com
www.bglight.com

SERVICE DATA

SYMBOLS

FAQ

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

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.

DECLARATION OF CONFORMITY

 | Bulgaria, 4027 Plovdiv 155, Vasil Aprilov blvd. office@bglight.com|

Declaration of conformity

| TD 7.2|
---|---|---|---|---
Revision 02|
Manufacturer:      BG LIGHT LTD

Address:                155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria Tel.: +359 32 644089, Fax: +359 32 641913

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 Medical electrical equipment – Part 1: General requirements for safety.

+AC:2010+A1:2013+A12:2014

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

BLUEDENT DATA

Last revision: 01.09.2021
Follow www.bglight.com for updated revision of this Operating instructions manual.

References

• About us - BG Light
• About us - BG Light

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