Blancone ARCUS+ User manual
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FIXED
www.blancone.eu/pro
Dental LED bleaching activation unit
Unità di attivazione dello sbiancamento dentale a LED
LED-Zahnbleaching-Aktivierungseinheit
Lampe d’activation à LED pour blanchiment dentaire
Unidad de activación de blanqueamiento dental led
Unidade de ativação do branqueamento dentário com LED
LED-Activeringsapparaat voor tanden bleken
Enhed til tandblegning med LED-lys
Hampaiden LED-valkaisun aktivointilaite Delete
Aktiveringsenhet for LED-tannbleking
LED-aktiveringsenhet för blekning av tänder
Stomatologiczne urządzenie aktywizujące wybielanie z użyciem diod LED
Fotoaktivační lampa na bělení zubů
Aktivačná jednotka na dentálne bielenie s LED svetlom
Unitate de activare pentru albire dentară cu LED-uri
Стоматологическая LED-лампа для активации отбеливания
LED ışıklı diş beyazlatma aktivasyon ünitesi
EN
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FR
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PT
NL
DA
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CZ
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RO
RU
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Instructions for Use
Istruzioni d’uso
Gebrauchsanweisung
Mode d’emploi
Instrucciones de uso
Instruções de uso
Gebruiksaanwijzing
Brugsanvisning
Mode Käyttöohjeet
Bruksanvisning
Bruksanvisning
Instrukcja obsługi
Návod k použití
Návod na použitie
Instrucțiuni de utilizare
Инструкция по применению
Kullanim talımatlari
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I. Unit description and functions............................2
II. Symbols ............................................................2
III. Safety precautions .............................................3
IV. .....................................8
V. Packaging / components....................................9
VI. Installation........................................................10
VII. Preparation for operation .................................12
VIII. Daily care and maintenance ............................13
IX. Preparation for work with patients....................13
X. Positions of bleaching head ............................14
against patient’s teeth
XI. Determination of distance ...............................15
to patient’s teeth
XII. Problems and solutions ...................................16
XIII. Warranty...........................................................17
XIV. Service data ....................................................17
XV. Declaration of conformity .................................18
XVI Led bleaching activation unit data .................325
Caution!
Before installing and operating
with the unit,
carefully read this manual.
(FIXED)
Dental LED bleaching
activation unit
I. UNIT DESCRIPTION AND FUNCTIONS
LED bleaching activation device BLANCONE
®
ARCUS
+
is an accessory to a medical device and is
designed to whiten hard dental tissues by photoactivation of a bleaching gel based on hydrogen or
carbamide peroxide, intended for light activation, applied in dental practice (concentrations of H2O2 or
their equivalent: 0.1 – 6% (cosmetic bleaching) or above 6% (medical bleaching).
The device consists of a Bleaching Head, Stand, Fixing bracket and a Power Adapter.
BLANCONE
®
ARCUS
+
is manufactured in conformity with the requirements of Regulation on medical
devices MDR 2017/745 and standards ISO 13485:2016, ISO 9001:2015.
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.
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EN
Catalogue number
Serial number
-
Batch code
Applied part type B
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.
III. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLANCONE
®
ARCUS
+
is a Class I accessory to a medical device and it meets the strict require-
ments 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:
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- 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.
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 BLANCONE
®
ARCUS
+
parts must be used when replacing defective parts. The war-
ranty 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).
- Before the patient undergoes whitening, he/she must sign an Informed Consent, which describes
in great detail the possible side effects of the process. Sample text can be found at www.blancone.
eu/pro > documents
- Fragile! Use caution when transporting, using and storing the device! When transported in
an assembled condition, two persons are required to keep the moving parts. With any unevenness
- 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 regula-
tions. 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.
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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 FSP060-DAAN3.
Electrical safety is ensured by class I protection against electric shock according to EN 60601-1.
BLANCONE
®
ARCUS
+
must only be operated indoors, under the following conditions:
- temperature from + 10 ° to + 40 ° C;
- relative humidity 30 - 75%;
- lack of dust in the room;
- atmospheric pressure 700 - 1060 hPa;
- 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!
To avoid the risk of electric shock, this device must only be connected to power supplies with pro-
tective earthing.
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
BLANCONE
®
ARCUS
+
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. Skin
pigmentation is possible.
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 pho-
to-biological reactions; persons taking photosensitive drugs; persons undergoing cataract surgery,
persons with retinal diseases, etc.
visual impairment in direct radiation, to loss of vision.
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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.
4. Fire safety
- Do not expose to direct sunlight.
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.
5. Danger of mechanical moving parts
- Assemble the mechanical parts, position them, lock them slowly with care.
- The device must not be used for transporting or moving people or objects.
- The counterweight must be fully screwed in order to avoid falling and injuring people and objects.
- Fix the emitting head well - at an appropriate height and distance to be stable in front of the pa-
tient’s teeth during the procedure.
- Do not turn the horizontal arm by force to avoid mechanical shocks with the counterweight or the
bleaching head. In the event of a mechanical shock, if the whitening head is damaged, the use of
the device must not be continued. It must be taken immediately to the company service center.
- To take measures against damage to the human body by mechanical parts (movable and immov-
able), pinching, inertial reinforcement of the counterweight, manipulations with the device to be
performed carefully to avoid injury.
locking mechanism. The wheel stoppers, if any, must be released before moving the bleaching
unit.
Risk of mechanical damage to the operator and the patient.
6. Who should not be bleached because of prohibitions and risk of burns
and complications:
- The device should not be used by: pregnant and breastfeeding mothers; patients with severe peri-
odontal pathology, with recessions, dental hyperesthesias and under 17 years of age; patients with
allergies, wounds and infections, fresh scars on the face, skin infections, recently placed dental
bruises, burns, cancer or indications of such on the face and lips cavity, atypical warts in the area of
- 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 hyaluron-
ic acid or botox, people with very sensitive skin or dermatitis, etc. If you are taking photosensitizers
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EN
that it may cause photoallergic reactions, or if you are required to avoid sun exposure after taking
this medicine.
Failure to follow the whitening protocol may result in pain, hypersensitivity, enamel damage, and
soft tissue burns.
7. What to do before bleaching:
- Talk to the patient to clarify the patient’s status and explain the prohibitions and risks and to an-
swer any questions.
by the patient.
- Isolation of soft tissues with a mask to avoid burns and skin reactions.
- Mandatory use of the safety goggles provided by the manufacturer for the operator and the pa-
tient. Do not use other types of glasses that may be dangerous to the eyes.
- Check the patient’s sensitivity to light intensity. The device has 2 levels of intensity and with the
distance to the teeth the optimal conditions are selected.
-
sation after 1-2 minutes is very strong, the distance should be increased to achieve an acceptable
thermal sensation.
(Low) and less distance to the teeth.
If the patient has no sensitivity or cannot judge the distance – it is advisable to work at a greater
- After selecting the appropriate intensity (HI or LO) and the distance between the device and the
patient’s lips between 5 and 15 cm, dentist must monitor how the patient reacts to this intensity
- for example after a few minutes of irradiation. Distance should be adjusted according to the pa-
tient heat response to avoid danger of side effects - burns. The heat effect is as strong as the light
effect. For example, in the summer or at high temperatures in the room, it is mandatory to increase
the distance to the patient by 1-2 cm.
- To have constant control over the procedure to ensure that the distance has not changed. The
patient should not be left unattended during the procedure.
- It is desirable to have a picture before and after the procedure of the teeth and soft tissues and
to monitor whether there is redness or other reaction. The photo should be stored long enough to
monitor the effect of whitening and possibly the soft tissue reaction.
8. What to do after bleaching:
- Examination of the patient after the procedure for redness and changes in the mucosa, if any,
to give him a prescription for appropriate treatment and to keep in touch with him in the coming
days until the disappearance of any problem. It is desirable for the dentist to keep in touch with a
dermatologist and to be able to offer a consultation with one in case of problems with the patient.
- The patient should be warned to observe the necessary hygiene and not to undertake self-medi-
cation, which may deepen the reaction and to maintain contact with the dentist if necessary.
- The clinic (dentist) takes full responsibility for quickly and effectively solving any problems in order
to ultimately obtain the desired aesthetic result without unwanted complications and consequenc-
es.
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IV.TECHNICAL SPECIFICATIONS
1.
Operating voltage to the power adapter - 100-240V / 50-60Hz, to the whitening head - 24VDC.
2. 2. Charging adapter - type FSP060-DAAN3, current consumption – 1,8 A max
3. Dimensions:
- Bleaching head
length - 220 mm
width - 155 mm
height - 95 mm
- Stand
length (assembled) - 52 cm / 80 cm with extended telescopic arm
height 26 cm
4. Weight:
- Bleaching head - 640 g
- Stand - 2000 g
5. Irradiance - HI mode (100%), LO mode (50%) measured at the output window
6. Operation time - 10 sec. - 30 min / ± 5% /
7. Emitted light - blue 430 - 490 nm.
8. Light source - 10 LED modules x 5W = 50W
9. Fan air cooling.
10. Ability to start and stop the Bleaching Head at any time.
11. Maximum continuous operation time 99 min – every 99 minutes
of continuous operation should have at least 10 minutes rest.
12. Degree of protection against electric current - applied part type B.
The manufacturer of this device will provide upon request the necessary
additional technical documentation / information necessary for the technical staff
as subject to repair.
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V. PACKAGING / COMPONENTS
1. Power cord 24 V DC
to the Bleaching Head
2. Straight arm
3. Telescopic arm
4. Central position
locking mechanism
5. Angular Arm
6. Fixing bracket
7. Bleaching head
positioning mechanism
8. Bleaching head
9. Dental unit vertical arm
10. Control panel
10A.
10B.
10C. Start / Stop button
10D. Display
11. Cable retaining clip
12. Cables and connectors
13. Safety glasses - 2 pcs.
14. Power Adapter
100-240V AC / 24V DC.
Fine positioning is done by turning the Bleaching head so that the light is perpendicular to the pa-
tient’s teeth and centered on them.
14
3 24
7
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11
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10
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D
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913
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VI. INSTALLATION
BLANCONE
®
ARCUS
+
of the dental unit.
1. Unpack the transport box, remove the
components and initially assemble the
sure the diameter of the bracket match-
es the diameter of the dental unit vertical
arm. Soft PVC tape strips are provided in
the case that there is a need to compen-
sate for small difference in the two diame-
ters. Tighten the two screws with a 4 mm
Allen key (included in the package).
2. Tighten the stop/safety screw with a 3
mm Allen key (included in the package).
3. Insert the cable through the small open-
arms.
4.
straight arm can move down and up for po-
sitioning.
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5. Mount the bleaching head by turning clock-
-
located on the straight arm, the telescopic
6. Connect the cable from the top of the angu-
lar arm to the one coming from the bleach-
Note: the device will not work if the cable
connectors are incorrectly coupled.
7. Connect the cable on the bottom of the an-
gular are with the power adapter using the
will not work if the cable connectors are in-
correctly coupled.
8. Plug the power cord into the power network, SHUKO socket.
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VII. PREPARATION FOR OPERATION
1. BLANCONE
®
ARCUS
+
bleaching activation device should be placed in a suitable position around the
patient and the dental unit. See the positioning examples (Section X).
The bleaching head must be in the same vertical plane and parallel with the arc of the teeth with a
distance between 5-15 cm. See the positioning examples (Section X).
2. Plug the power adapter into the power network. Only one point/dot on the display
-
sity indication appears.
3.
intensity mode, press the TIMER / MODE (+ / -) button once. Then the display will
Hi or Lo intensity level.
4. Press the START / STOP button once again and set time option will be displayed.
Note that the device will save the time frame used in the latest bleaching procedure.
Required timeframe for operation is set by pressing TIMER + (increasing time) and
TIMER- (reducing time):
The display on the bleaching head will indicate timeframes between 10 sec. and 9
min. and 50 sec. with a dot between the two digits.
Examples:
Display indicates: 13. This means the timeframe is set to 13 min.
Display indicates: 0.1. This means the timeframe is set to 10 sec.
Display indicates: 9.5. This means the timeframe is set to 9 min. and 50 sec.
The display on the bleaching head will indicate timeframes between 10 min. and 30
min. without a dot between the two digits.
5.
display will indicate that the device is working properly.
6. If either of the TIMER / MODE (+ / -) buttons is pressed dur-
ing operation, the unit switches to Pause mode. A blinking
display with the remaining time will indicate that the device
is paused. Operation is resumed by pressing any TIMER /
MODE (+ / -) button again.
7. To Stop the bleaching device at any time press the START
/ STOP button. If the device is not manually stopped it will
stop after the selected time has elapsed. Note that the fan will continue to work for some time in order
to cool down the unit.
8. At the end of the day turn off the device by holding down
the Start / Stop button for 3-4 seconds or by disconnecting it from the power network.
LED Bleaching Unit
ARCUS
ON/OFF
TIME
MODE
LED Bleaching Unit
ARCUS
ON/OFF
TIME
MODE
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EN
9. In case of overheating the thermal protection is triggered and the device will
1 minute. After cooling, the device will continue its normal operation, but stays
in Pause mode. Overheating can only happen in an emergency situation or
by accidental clogging of the cooling vents. For this reason the cooling vents
located on the bottom of the bleaching head must always be unobstructed in
order to allow air circulation.
VIII. DAILY CARE AND MAINTENANCE
1. Disinfection of the PVC window of the bleaching head
For each patient, the emitting window is cleaned
with a cotton swab soaked in an alcohol solution.
2. Cleaning the device:
To disinfect the device and its parts, spray disinfectant on a piece
of soft cloth or cotton and clean.
Do not use abrasives or solvents, as this may damage parts of the device!
IX. PREPARATION FOR WORK WITH PATIENTS
LED bleaching activation device BLANCONE ARCUS+ is an accessory to a medical device and is designed
to whiten hard dental tissues by photoactivation of a bleaching gel based on hydrogen or carbamide perox-
ide, intended for light activation, applied in dental practice (concentrations of H2O2 or their equivalent: 0.1
– 6% (cosmetic bleaching) or above 6% (medical bleaching).
1. Before starting work with the bleaching device, insulate the patient’s
apply protective UV cream and put on protective glasses. Bleaching gel
is applied to the teeth surface according to the directions for use outlined
by the gel manufacturer.
The patient should be under constant supervision by the dentist during
the bleaching process in order to avoid discomfort and to ensure all safe-
ty and technological procedures are applied.
2. It is desirable to check the individual sensitivity of the patient. The device has two levels of intensity
(high HI and low LO) and the optimal conditions are selected by adjusting the distance of the device
to the patient’s teeth.
the distance is increased to achieve an acceptable thermal sensation.
(Low) and put the bleaching head closer to the teeth to obtain optimal distance.
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EN
X. POSITIONS OF BLEACHING HEAD AGAINST PATIENT’S TEETH
CORRECT INCORRECT
5-15 cm distance
POSSIBLE LAMP POSITIONING WITHIN DENTAL UNIT
BLEACHING STAND-BY
STAND-BY
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BLEACHING ACTIVATION UNIT OPERATIVE POSITIONING
XI. DETERMINATION OF DISTANCE TO PATIENT’S TEETH
5 cm distance
5 cm distance
9 cm distance
9 cm distance
15 cm distance
15 cm distance
HIGH intensity
LOW intensity
Hot
Accetable
Warm
Weak
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Dental LED bleaching activation unit - FIXED
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XII. PROBLEMS AND SOLUTIONS
The device does not work.
Check if the power cord from the adapter is plugged into the power network and all cable connectors
are correctly coupled. Use only the original adapter type FSP060-DAAN3.
Damaged power cord.
Do not use the device! Switch it off and replace the cable with new one or take the device to the
service facility.
Unpleasant or irritating thermal sensation by the patient.
Increase the distance of the device to the patient’s teeth to 10-15 cm. If the thermal sensation is still
The display is blinking and no light is emitted.
The device is in PAUSE mode. To resume operation, press either (+) or (–) TIMER button.
The display only shows “Oh”.
The device has protection against overheating, and is activated if the temperature in the emitting
minute. After cooling, the device returns to normal operation. Overheating can only occur in an
emergency or when the cooling openings are blocked. Therefore, the cooling openings in the lower
part of the radiating head must always be free for air circulation.
For all other questions regarding installation and operation of the BLANCONE
®
ARCUS
+
, contact the
manufacturer or your local dealer.
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Dental LED bleaching activation unit - FIXED
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XII. WARRANTY
1. The warranty period of the BLANCONE®ARCUS+bleaching activation device is 24 (twenty-four) months
2. During the warranty period, the replacement of the defective elements is carried out free of charge by the
manufacturer. Note - LED modules have a 6-month warranty.
3. The device and its components must only be used as intended by the manufacturer purpose outlined in this
Operating instruction. Any other use will void the warranty and the manufacturer is not liable for any damag-
es or damages caused by it.
4. If during the warranty period the device fails due to improper operation (mechanical, chemical, thermal,
electrical), non-intended use, inappropriate storage etc.., warranty will be void and the repair cost will be at
the expense of the user.
The device should not be used with damaged cables. If any such damages are noticed switch off the device
and immediately take it to the service facility.
wiping the device with them, insects or rodents enter the device, the device must be taken immediately to
the service facility. Damages from the above will void the warranty.
No claims shall be accepted for damages arising from electrical shocks, thunderstorms, non-compliance
plants, and objects from light radiation.
-
aged or malfunctioned, no matter what the reason.
Claims for damages and claims due to of non-compliance with the bleaching procedure are not accepted.
Including but not limited to: shorter or longer time period use of the device with the bleaching material set by
the gel manufacturer; unsatisfactory bleaching result; patient’s harms from the bleaching material; overdos-
inappropriate, expired, intended for another wavelength and/or with unsuitable concentration bleaching ma-
terial.
care and attention for protection during transport, unpacking, moving, handling and storage of the device.
In the event of disputes arising out of the application and interpretation of this Operating Instructions Manual,
those will be settled by the courts in the city of Plovdiv, under the current Bulgarian legislation.
5. -
nel outside of the manufacturer’s service facilities and/or non-original spare parts are used.
6. The manufacturer recommends that customers should check whether the device parameters are within the
manufacturer’s service facilities or by an authorized representative.
7. Sending for repair to the company service must be done in the original packaging of the product.
8. All repairs must be done at the manufacturer’s service facilities with the following address:
IDS SPA
Via San Cristoforo, 28/10 - 17100 Savona
Tel. 019-862080 - www.idsdental.it
XIV. SERVICE DATA
Repair service only valid for the EU territory, for countries outside the EU please contact your dealer. All the
equipment distributed by us that will need technical interventions during or outside the warranty period, must be
sent directly to the company Vi.Vi.Med srl who will manage the repair and invoice.
VI.VI.MED Srl
Technical Service
Via Tevere 11 - 51018 Pieve a Nievole (PT) – Italy
Tel. +39 0572 520910 - fax. +39 0572 520807 - Mobile: +39 347 5250335
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Dental LED bleaching activation unit - FIXED
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XV. DECLARATION OF CONFORMITY
TECHNICAL FILE
BLANCONE ARCUS+
LED bleaching activation unit
EU Declaration of conformity
Developed in conformity with MDR (EU) 2017/745
ТD 7.2
Revision 02
Manufacturer: BG LIGHT LTD
SRN: BG-MF-000019812
Address: 155, Vasil Aprilov blvd., 4027 Plovdiv, Bulgaria
Tel.: +359 32 644089, +359 888 809256, email: [email protected]
BULSTAT UIC 115841960, VAT N: BG115841960
Product: Product code: Name:
Dental LED bleaching
activation unit
600-001bt+ BLANCONE ARCUS+ (mobile)
Basic UDI: 3800501374600000XK
EMDN code: Q0190
Classification: Active invasive device (accessory for medical device) of Class I of the Regulation on medical devices -
MDR (EU) 2017/745
Intended purpose: BLANCONE ARCUS+ is designed to bleach the solid tooth tissue by photoactivation (irradiation of blue light
430-490 nm) of dental bleaching gel. BLANCONE ARCUS+ is accessory for a medical device as described in article 2, p.(2) as it
performs its intended purpose together with dental bleaching gel.
The manufacturer declares under its own responsibility that the specified medical device complies with the applicable GENERAL
SAFETY AND PERFORMANCE REQUIREMENTS, defined in Annex I of the normative act described below and normative
technical documents, when used for its intended purpose and in accordance with the safety requirements.
Document Title Edition /
date of issue
Regulation
(EU)
2017/745
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC
and 93/42/EEC
05.05.2017
(last change
24.04.2020)
To achieve compliance, the requirements of the following standards are met:
EN ISO 13485:2016 +/AC:2017/
/AC:2018/ A11:2022 +/AC:2017/
/AC:2018/ A11:2022
Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 9001:2015 Quality management systems - Requirements
ЕN ISO 60601-1:2006
/A1:2013/AC:2014/A2:2022
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2:2015/A1:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-6:2010+ /A1:2015 /
/A2:2021
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN 60601-1-8:2007+ /A1:2013
/A11:2017 /A2:2021
Medical electrical equipment — Part 1-8: General requirements for basic safety and essential
performance — Collateral standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
EN ISO 10650:2018 Dentistry - Powered polymerization activators
EN 62304:2006/А1:2015 Medical device software. Software life cycle processes.
EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
EN 62366-1:2015+ AC:2016/
A1:2020
Medical devices. Application of usability engineering to medical devices.
EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice
EN ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management
process
EN ISO 14971:2019+/A11:2022 Medical devices – Application of risk management to medical devices.
CEN ISO/TR 24971:2020 Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer –
Part 1: General requirements
EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer
Directive 2012/19/EC Directive on waste electrical and electronic equipment (WEEE)
Classification is done by the manufacturer according to Regulation on medical devices - MDR (EU) 2017/745, Annex VIII, Rule 13.
Conformity assessment procedure according to article 52, paragraph 7 of MDR (EU) 2017/745.
The declaration of conformity is issued in implementation of Annex IV “EU Declaration of conformity” of EU Regulation 2017/745,
based on the results of tests carried out and assessment of compliance with the General safety and performance requirements
defined in Annex I, implemented and certified Quality Management System - certificates No: AC090 100/1971/4047/2020, AC090
MD/1971/4047/2020 from TUV NORD Polska Sp. z o.o. (NB 2274).
BG LIGHT LTD maintains data on the provision, evaluation and maintenance of compliance of the medical device, according to
the requirements of Annex II "Technical documentation" of MDR (EU) 2017/745.
Plovdiv, Bulgaria Dipl. Eng. Plamen Karaivanov
01.01.2023 Manager
BG LIGHT LTD
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