Unit Description And Functions; Symbols - Blancone ARCUS+ Instrucciones De Uso

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I. UNIT DESCRIPTION AND FUNCTIONS
LED bleaching activation device BLANCONE
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 H
their equivalent: 0.1 – 6% (cosmetic bleaching) or above 6% (medical bleaching).
The appliance should only be used by a qualified dentist and in a dental practice.
The device consists of a Bleaching Head, Stand and a Power Adapter.
BLANCONE ARCUS
®
cal 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 - MOBILE
is manufactured in conformity with the requirements of Regulation on medi-
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ARCUS is an accessory to a medical device and is
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®
TOUCH
STICK
HOME
DAY
CARE
ULTRA
DUETTO
HOME
NIGHT
DUETTO
ACTIVE
O or
2 2
CLICK
ARCUS
LIPS
ARCUS
DUETTO
CARE