mectron starlight s +, Руководство по установке

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starlight s +
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.
Although most composite materials are activated within this wavelength range, in case of
uncertainty consult the specifications of the composite material or contact the manufacturer.
This equipment may be used only in a dentist’s surgery or out-patient’s department where there
are no inflammable gases (anaesthetic mixtures, oxygen, etc.).
1.2 Description of the Device
starlight s + is an equipment for polymerising photo-hardening composites.
The light source used is a very high-efficiency monochromatic LED with a dominant wavelength
between 440 nm and 465 nm.
Unlike traditional halogen lamps, therefore, all the light being emitted by starlight s + is used to
activate the camphorquinone photoinitiator.
1.2.1 Patient Group Directions
this medical device is designed to be used with the following patient population:
• Children;
• adolescents;
• adults;
• Elderly.
This medical device can be used on any patient (if applicable) of any age, weight, height, gender
and nationality.
1.2.2 Patient Selection Criteria
the use of the device is not recommended in the following cases:
1.
Patients with active implantable medical devices (for example: pacemakers, hearing aids
and/or other electromagnetic prostheses) without the prior authorization of their doctor;
2. Patients with a history of light stimulation, for example in photoexposure dermatitis and/
or porphyrias, etc. or who are being treated with photosensitizing drugs. In all cases of
possible risk, consult a specialist doctor;
3. Patients whose medical history shows pathologies of the retina must first consult the
ophthalmologist to receive authorization for treatment with the Mectron curing light.
WARNING: adopt strict safety measures for patients who have undergone cataract surgery
and are therefore particularly sensitive to light (for example, safety glasses that filter out blue
light).
All models of curing lights are intended for professional use only. Therefore, the user is the only
person able to decide if and how to treat their patients.
WARNING: Contraindications. In all cases of potential risk, a specialist doctor must be
consulted.