Blancone ARCUS+, Instructions For Use Manual

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I.UNIT DESCRIPTION AND FUNCTIONS
BLANCONE
®
ARCUS
+
LED bleaching device is a medical device designed to whiten the solid tooth tissue
by photoactivation of a whitening gel used in dentistry (6-39% hydrogen peroxide or equivalent).
The appliance should only be used by a qualified 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 fixing bracket - 50 mm.
Optional fixing 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 specified
as subject to repair.
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LED Bleaching Lamp - FIXED 2
GB