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mectron Starlight Pro - Intended Use; Description of the Device; Patient Group Directions; Patient Selection Criteria

mectron Starlight Pro
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2
starlight pro
1.1 Intended Use
Polymerisation of photo-hardening dental materials with a photoinitiator that can be activated
in the wavelength band comprised between 440 and 480 nm with a narrow peak at 460 nm.
            

This equipment may be used only in a dentist’s surgery or out-patient’s department where there

1.2 DescriptionoftheDevice
starlight pro is an equipment for polymerising photo-hardening composites.

between 440 nm
and 465 nm.

activate the camphorquinone photoinitiator.


The device consists of a charging unit with a brightness meter and a handpiece powered by a
rechargeable lithium-ion battery.
starlight pro can be used to operate in either of two emission modes:
Constant intensity of emission - FAST (cycle lasting 10 seconds);
Gradual intensity of emission - SLOWRISE (cycle lasting 20 seconds).
1.2.1 PatientGroupDirections
This medical device is designed to be used with the following patient population:
Children;
Adolescents;
Adults;
Elderly.

and nationality.
1.2.2 PatientSelectionCriteria
The use of the device is not recommended in the following cases:
1. 
and/or other electromagnetic prostheses) without the prior authorization of their doctor;
2. 


3. 
ophthalmologist to receive authorization for treatment with the Mectron curing light.
WARNING:Adopt strict safety measures for patients who have undergone cataract surgery

light).

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