Safety Requirements - Mectron starlight pro Manual De Uso Y Mantenimiento

starlight pro
1.4 Safety Requirements
CAUTION: No alterations to this device are permitted.
CAUTION: The electrical system of the premises in which the device is installed and used
must comply with the rules in force and the relevant requirements of electrical safety.
WARNING: Qualified and specialised personnel.
the device must be used exclusively by specialized personnel with proper medical culture; no
training activities are foreseen for the use of the device. The use of the device does not cause
side effects if it is used correctly.
WARNING: Intended use.
Use the equipment solely for the purpose for which it is intended (see
2 ). Failure to comply with this requirement could lead to serious harm to the patient and/or
to the operator and/or damage to/failure of the equipment.
WARNING: Contraindications.
Do not use the device on patients with Pacemakers or other implantable electronic devices.
This regulation also applies to the operator.
WARNING: Point the beam of light directly at the material to be polymerised.
Do not point the beam of light on the gums or other soft tissues (if necessary these parts
should be suitably shielded). the effect of the light should be limited to that part of the oral
cavity to be clinically treated..
WARNING: Never point the beam of light on the eyes.
the effect of the light should be limited to that part of the oral cavity to be clinically treated.
WARNING: Contraindications.
Do not use this equipment for patients who have a case history of positive reaction to
stimulation by light, e.g. urticaria solaris and/or porphyria, etc. or who are receiving treatment
with photosensitising drugs. In all cases of possible risk consult a specialised physician.
WARNING: Contraindications.
Adopt strict safety measures for patients who have undergone cataract surgery and who are
therefore particularly sensitive to light (e.g. protective goggles able to filter out blue light).
WARNING: Contraindications.
Patients who have a case history of diseases of the retina should consult their optician
beforehand and be specifically authorised to receive treatment with the starlight pro.
CAUTION: Photobiological safety of the curing lights and lamp systems IEC 62471.
According to the Standard IEC 62471, the device results in risk class 2 (moderate risk)
concerning a retinal risk from blue light or thermal retinal risk.
the following CAUtION indications are applied to the device package.
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Chapter 1.1 on page