IDS BLANCONE ARCUS+ FIXED User manual

LED Bleaching Lamp
Lampada sbiancante a LED
LED Bleachinglampe
Lampe de blanchiment dentaire à LED
Lámpara de blanqueamiento con LED
Lâmpada de branqueamento com LED
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FIXED

Instructions for Use ................................... 1
Istruzioni d’uso.......................................... 17
Gebrauchsanweisung ............................. 33
Mode d’emploi......................................... 49
Instrucciones de uso................................ 65
Instruções de uso..................................... 81
INDEX
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LED Bleaching lamp
FIXED
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I. Unit description and functions..................... 2
II. Technical specications ............................... 2
III. Packaging / components............................ 3
IV. Safety precautions ........................................ 3
V. Installation ..................................................... 8
VI. Preparation for operation ........................... 10
VII. Daily care and maintenance..................... 11
VIII. Preparation for work with patients.............. 12
IX. Positions of bleaching head....................... 12
against patient’s teeth
X. Determination of distance ......................... 15
to patient’s teeth
XI. Problems and solutions .............................. 15
XII. Warranty ...................................................... 16
XIII. Symbols ....................................................... 97
XIV. Service data ............................................... 97
XV. Declaration of conformity........................... 98
XVI. Led bleaching unit data ............................ 99
Caution!
Before installing and operating
with the unit,
carefully read this manual.

I.UNIT DESCRIPTION AND FUNCTIONS
BLANCONE
®
ARCUS
+
LED bleaching device is designed to whiten the solid tooth
tissue by photoactivation of a whitening gel used in dentistry.
The appliance should only be used by a qualied dentist and in a dental practice.
The device consists of a Bleaching Head, Stand,Fixing bracket and a Power Adapter.
BLANCONE
®
ARCUS
+
is manufactured in conformity with the requirements
of standards ISO 9001:2015, ISO 13485:2016 and Medical Devices Directive 93/42/EEC.
II.TECHNICAL SPECIFICATIONS
1.
Operating voltage to the power adapter - 100-240V / 50-60Hz,to the whitening head - 24VDC.
2. Current consumption - 0.4-0.2 A
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
maximum diameter of the standard xing bracket - 50 mm.
Optional xing brackets with max.diameters 60mm, 70mm, 80mm and 90mm
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.
The manufacturer of this device will provide upon request the necessary
additional technical documentation / information necessary for the technical staff
of the user to repair those parts of the device that the manufacturer has specied
as subject to repair.
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III. 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. “+”Timer or “Pause” button
10B. “-”Timer or “Pause” button
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
patient’s teeth and centered on them.
If the movement of the Bleaching head is difcult or it does not hold the selected position it is nec-
essary to adjust the Bleaching head positioning (7) and Telescopic xator locking mechanism (4).
IV. SAFETY PRECAUTIONS
GENERAL WARNINGS:
BLANCONE
®
ARCUS
+
is a Class IIa medical device and it meets the strict requirements of the
Medical Devices Directive 93/42 / EEC. In order to be used safely for staff and patients, the fol-
lowing 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 disin-
fectant is acceptable.
- Do not get wet or drop liquid on the device, cables, adapter to avoid electric shock or dam-
age 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 elds 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 techni-
cians 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
- Note: It is recommended to attend a suitable training“Teeth whitening in a dental ofce”!
- 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 une-
venness on the ooring, the device should only be moved by two people.
- 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 spe-
cialized 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 con-
sequences 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.Electrical safety is ensured by class II 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;
- absence of chemically active and ammable 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 nec-
essary 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-fac-
tor 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 pho-
to-biological reactions; persons taking photosensitive drugs; persons undergoing cataract sur-
gery, persons with retinal diseases, etc.
The risk of improper irradiation is severe eye irritation, temporary spots in the visual eld, severe
visual impairment in direct radiation, to loss of vision.
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3. Fire safety
- Keep the device away from solvents, ammable 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
re 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 re, explosion and damage.
4. 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.
- Fix the emitting head well - at an appropriate height and distance to be stable in front of the
patient’s teeth during the procedure.
- Do not turn the horizontal arm by force to avoid mechanical shocks with 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 im-
movable), pinching, manipulations with the device to be performed carefully to avoid injury.
- The movement of the parts of the device without prior unscrewing of the xators can damage
their locking mechanism.
Risk of mechanical damage to the operator and the patient.
5. 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
periodontal pathology, with recessions, dental hyperesthesias and under 17 years of age; pa-
tients with allergies, wounds and infections, fresh scars on the face, skin infections, recently
placed dental implants or surgical procedures in the oral cavity and face,bral conditions,her-
pes,bleeding,bruises,burns,cancer or indications of such on the face and lips cavity,atypical
warts in the area of irradiation, difcult to heal wounds; patients taking painkillers that dull the
skin’s sensitivity to heat; persons under the inuence of alcohol or narcotics.
- The device can be used only after medical consultation on or by: persons with implanted
cardiac pacemaker; persons suffering from photobiological reactions; persons taking photo-
sensitive drugs; persons undergoing cataract surgery; persons with retinal diseases; people
with allergies; people who have recently undergone cosmetic surgery on the face or lips, in-
cluding injections of hyaluronic acid or botox, people with very sensitive skin or dermatitis,etc.
If you are taking photosensitizers or medicines,check the package leaet and never undergo
bleaching procedure if it is indicated 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.
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6.What to do before bleaching:
- Talk to the patient to clarify the patient’s status and explain the prohibitions and risks and to
answer any questions.
- Familiarization of the patient with the content of the “Informed Consent” and its mandatory
signing 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
patient. 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.
Testing begins with a high level of intensity“Hi”(High) and a distance of 5-6 cm and if the heat
sensation after 1-2 minutes is very strong, the distance should be increased to achieve an
acceptable thermal sensation.
If the heat sensation is very strong at 10-15 cm, then it is better to switch to low intensity - “Lo”
(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 great-
er distance and mode “Lo”.
- 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 accord-
ing to the patient 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.
7.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-medication, 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
consequences.
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V. INSTALLATION
BLANCONE
®
ARCUS
+
BUILT-IN is designed to be mounted with a xing bracket to the vertical arm
of the dental unit.
1. Unpack the transport box, remove the
components and initially assemble the x-
ing bracket to the dental unit. Make sure
the diameter of the bracket matches the
diameter of the dental unit vertical arm.
Soft PVC tape strips are provided in the
case that there is a need to compensate
for small difference in the two diameters.
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-
ing of the xing bracket and place the an-
gular arm in it.
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4. Attach the straight arm. Tighten the stop/
safety screw with a 3 mm Allen key (included
in the package). Make sure that the straight
arm can be moved up and down for precise
positioning.
5. Altering the force required to move the
straight arm up and down is done by adjust-
ing the screw (located on the back of the
central position locking mechanism) with a
5 mm Allen key (included in the package).
6. Mount the bleaching head by turning clock-
wise the positioning xator located on the
telescopic arm. By turning the conical xator
located on the straight arm, the telescopic
arm is rmly xed.
7. Connect the cable from the top of the angu-
lar arm to the one coming from the bleach-
ing head using the connectors (see gure).
Note: the device will not work if the cable
connectors are incorrectly coupled.
8. Connect the cable on the bottom of the an-
gular are with the power adapter using the
connectors (see gure).Note: the device will
not work if the cable connectors are incor-
rectly coupled.
9. Plug the power cord into the power network,
SHUKO socket.
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VI. PREPARATION FOR OPERATION
1. The BLANCONE
®
ARCUS+ bleaching device should be placed in a suitable position around
the patient and the dental unit. See the positioning examples (Section IX).
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 IX).
2. Plug the power adapter into the power network. Only one point/dot on the
display lights up. Press START / STOP button and then the “Hi” (High) or “Lo”
(Low) intensity indication appears.
3. The display shows “HI” - a high intensity level.If you want to switch to the “Lo”
(Low) intensity mode, press the TIMER / MODE (+ / -) button once.Then the
display will show“Lo”. Every time before setting the required time, you will be
able to select the Hi or Lo intensity level.
4. Press the START / STOP button once again and set time option will be dis-
played. Note that the device will save the timeframe used in the latest
bleaching procedure. Required time frame 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.
Press the START / STOP button one nal time and the
device will start to emit light.A ashing dot on the dis-
play will indicate that the device is working properly.
6. If either of theTIMER / MODE (+ / -) buttons is pressed
during 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.
LED Bleaching Unit
ARCUS
ON/OFF
TIME
MODE
LED Bleaching Unit
ARCUS
ON/OFF
TIME
MODE
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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.
9. In case of overheating the thermal protection is triggered
and the device will cease to emit light.The display will indi-
cate“Oh”and the fans will turn on for 1 minute.After cooling,
the device will continue its normal operation, but stays in
Pause mode. Overheating can only happen in an emer-
gency situation or by accidental clogging of the cooling
vents. For this reason the cooling vents located on the bot-
tom of the bleaching head must always be unobstructed in
order to allow air circulation.
VII. 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!
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VIII. PREPARATION FOR WORK WITH PATIENTS
1. Before starting work with the bleaching device, insulate the patient’s
non-calcied soft tissue, place a cover or protective napkin on the
face, apply protective UV cream and put on protective glasses.
Bleaching gel is applied to the teeth surface according to the direc-
tions for use outlined by the gel manufacturer.
The patient should be under constant supervision by the dentist dur-
ing the bleaching process in order to avoid discomfort and to ensure
all safety 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.
Testing starts with a high intensity “Hi” and a distance of 5 cm and if the heat sensation is very
strong, the distance is increased to achieve an acceptable thermal sensation.
If the acceptable distance is more than 10 cm, it is better to switch to a mode with low intensity -
“Lo”(Low) and put the bleaching head closer to the teeth to obtain optimal distance.
IX. POSITIONS OF BLEACHING HEAD AGAINST PATIENT’S TEETH
CORRECT INCORRECT
5-15 cm distance
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POSSIBLE LAMP POSITIONING WITHIN DENTAL UNIT
BLEACHING STAND-BY
STAND-BY
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ARCUS UNIT OPERATIVE POSITIONING
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X. DETERMINATION OF DISTANCE TO PATIENT’S TEETH
XI. 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.
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 unpleas-
ant at this distance switch to low intensity-“Lo” (Low) and shorten the distance to the teeth.
The display is blinking and no light is emitted.
The device is in PAUSE mode.To resume operation, press either (+) or (–) TIMER button.
The Bleaching Head cannot be xed.
Tighten the xing ball until the desired head position is reached (see Chapter V., point 5).
The display only shows “Oh”.
The device has protection against overheating, and is activated if the temperature in the emitting head
rises.Then the light stops,the display shows“Oh”- Overheating - and the fans work for 1 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 manu-
facturer or your local dealer.
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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LED Bleaching Lamp - FIXED
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XII.WARRANTY
1. The warranty period of the BLANCONE
®
ARCUS+ bleaching device is 24 (twenty-four) months from the
date of purchase. If the purchase date is not lled in, the warranty begins on the date of production.
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 damages or damages caused by it.
4. If during the warranty period the device fails due to improper operation (mechanical, chemical, ther-
mal, 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.
If liquids such as water and solvents,aggressive or ammable substances and their vapors, watering or
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-compli-
ance with electrotechnical safety measures or insufcient protection of patients, staff, other people,
animals, plants, and objects from light radiation.
The manufacturer does not owe any compensation for lost prots during the period when the device is
damaged or malfunctioned, no matter what the reason.
Claims for damages and claims due to of non-compliance with the bleaching procedure are not ac-
cepted.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 bleach-
ing material;overdosage; insufcient insulation of patient’s non-calcied soft tissue; improper protection
of the patient and staff; inappropriate,expired,intended for another wavelength and/or with unsuitable
concentration bleaching material.
The warranty is forfeited and no claims shall be accepted for damages as a result of incorrect or insuf-
cient 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. The warranty of the device will be forfeited if any repairs or modications are done by unauthorized
personnel 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 permissible limits once a year.Technical condition tests and verications may only be carried out at
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:
See section XIV. SERVICE DATA
at the end of the booklet
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LED Bleaching Lamp - FIXED
16
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+
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+
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+
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+
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Lampada sbiancante a LED
FIXED
IT
I. Descrizione e funzioni della lampada....... 18
II. Speciche tecniche .................................... 18
III. Imballaggio / Componenti........................ 19
IV. Indicazioni di sicurezza ............................... 20
V. Installazione................................................. 24
VI. Preparazione all’uso.................................... 26
VII. Cura quotidiana e manutenzione ............ 27
VIII. Preparazione all’uso con i pazienti ............ 30
IX. Posizioni della testa sbiancante................. 30
rispetto ai denti
X. Determinazione della distanza .................. 31
rispetto ai denti
XI. Problemi e soluzioni..................................... 31
XII. Garanzia ..................................................... 32
XIII. Simboli ........................................................ 97
XIV. Dati di servizio ............................................. 97
XV. Dichiarazione di conformità ....................... 98
XVI. Dati relativi alla lampada .......................... 99
sbiancante a led
Attenzione!
Prima dell’installazione ed utilizzo
della lampada,
leggere attentamente
il presente manuale!

I. DESCRIZIONE E FUNZIONI DELLA LAMPADA
La lampada sbiancante a LED BLANCONE®ARCUS+è progettata per lo sbiancamento dei tessuti duri
dentali tramite la fotoattivazione di un gel sbiancante usato nella pratica odontoiatrica.
Il dispositivo può essere utilizzato esclusivamente da dentisti qualicati nello studio odontoiatrico.
Il dispositivo consiste di testa sbiancante,stativo, staffa di ssaggio ed adattatore di alimentazione.
La lampada BLANCONE®ARCUS+è prodotta in conformità a quanto previsto dagli standard ISO 9001:2015,
ISO 13485:2016 e dalla Direttiva 93/42/CEE sui dispositivi medici.
II. SPECIFICHE TECNICHE
1.
Tensione d’esercizio all’adattatore - 100-240V / 50-60Hz, alla testa sbiancante - 24VDC.
2.
Consumo energetico - 0.4-0.2 A
3.
Dimensioni:
- Testa sbiancante
lunghezza - 220 mm
larghezza - 155 mm
altezza - 95 mm
- Stativo
lunghezza (una volta assemblato) - 52 cm / 80 cm con braccio telescopico esteso
altezza - 26 cm
diametro massimo della staffa di ssaggio standard - 50 mm.
Staffe di ssaggio alternative con diametro massimo 60mm, 70mm, 80mm e 90mm
4.
Peso:
- Testa sbiancante - 640 g
- Stativo - 2000 g
5.
Irradiazione - modalità HI (100%), in modalità LO (50%) misurata alla nestra d’uscita
6.
Tempo di funzionamento - 10 sec. - 30 min / ± 5% /
7.
Luce emessa - blu 430 - 490 nm.
8.
Fonte luminosa – 10 moduli LED da 5W = 50W
9.
Raffreddamento ad aria forzata.
10.
Possibilità di avvio ed arresto della testa sbiancante in qualsiasi momento.
11.
Tempo massimo di funzionamento continuo 99 min – dopo 99 minuti di funzionamento
continuo lasciare raffreddare la lampada per almeno 10 minuti.
Su richiesta, il produttore di questo dispositivo fornirà eventuale documentazione tecnica e/o informazioni aggiuntive ne-
cessarie al personale tecnico dell’utilizzatore per procedere alla riparazione di quelle parti del dispositivo che il produttore
ha indicato come soggette ad eventuale riparazione.
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Lampada sbiancante a LED - FIXED
18
IT
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