Blancone ARCUS+ User manual
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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
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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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Dental LED bleaching activation unit - FIXED
2
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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Dental LED bleaching activation unit - FIXED
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