Blancone ARCUS+ Bedienungsanleitung Seite 2

EN
BLANCONE WHITENING SYSTEM
BlancOne ARCUS lamp and BlancOne photochemical whitening Gels (ULTRA, TOUCH, CLICK) are engi-
neered to function as a cohesive system, essential for ensuring patient safety and treatment efficacy.
BlancOne ARCUS lamp must be used exclusively with BlancOne photochemical whitening gels and not
independently. Conversely, BlancOne photochemical gels should only be activated using BlancOne ARCUS
lamp. For patient safety and to ensure the efficacy of the treatment, BlancOne photochemical gels (ULTRA,
TOUCH, CLICK) must be activated using BlancOne ARCUS lamp. The unique properties of the Blanc One
Arcus lamp, including specific wavelength and intensity, are essential for the proper activation of these gels.
Patients must be protected using BlancOne CARE protections for eyes, face and lips.
Dental care professionals must undergo a training and certification to verify their understanding of and com-
mitment to adhering to safety protocols when using the BlancOne In-Office Whitening System. Authorized
dealer is responsible for providing or facilitating this training and certification, ensuring that all users of the
system are compliant and competent according local healthcare guidance.
Any serious adverse health issues or reactions associated with the BlancOne Whitening System must be re-
ported to the authorized dealer who is responsible to record a comprehensive report about the incident and
for reporting it to national healthcare authority and IDS Spa. Are exempted from this requirement common
adverse effect of teeth whitening such as mild and transitory hypersensitivity and gum irritations.
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 dental professional in a dental practice.
The device consists of a Bleaching Head, Stand and a Power Adapter.
BLANCONE ARCUS
®
ical devices MDR 2017/745 and standards ISO 13485:2016, ISO 9001:2015, EN 60601-1, EN
60601-1-2.
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.
2
Dental LED bleaching activation unit - MOBILE
is manufactured in conformity with the requirements of Regulation on med-
+
ARCUS is an accessory to a medical device and is
+
®
TOUCH
STICK
HOME
DAY
CARE
ULTRA
DUETTO
HOME
NIGHT
DUETTO
ACTIVE
O or
2 2
CLICK
ARCUS
LIPS
ARCUS
DUETTO
CARE