mectron Silverlight - 00.4 Safety Requirements

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silverlight - manual of use and maintenance
00.4 Safety requirements
The manufacturer Mectron S.p.A. and the importer/distributor, GC America Inc, will not accept any liability
for direct or incidental personal injury or damage to property in the following cases:
1 If the equipment is used for purposes other than that for which it is intended.
2 If the equipment is not used in accordance with all the instructions and requirements described in this
manual.
3 If the wiring system in the room where the equipment is used does not comply with the applicable
standards and appropriate requirements.
4 If any assembly operations, extensions, settings, alterations or repairs have been carried out by
personnel not authorized by GC America Inc. or its afliates.
5 If the environmental conditions in which the device is kept and stored do not comply with the
requirements indicated in the chapter on technical specications.
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DANGER: Qualied and specialized personnel.
The equipment should be used only by specialized personnel having the appropriate training.
The equipment does not produce any side effects if it is correctly used.
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DANGER: Intended use.
Use the equipment solely for the purpose for which it is intended (see point “00.3”). 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.
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DANGER: Contraindications.
Do not use this equipment on patients tted with pace-makers or any other implantable electronic devices.
This requirement applies equally to the operator.
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DANGER: Point the beam of light directly at the material to be polymerized.
Do not use 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.
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DANGER: Never point the beam of light towards the eyes.
The effect of the light should be limited to that part of the oral cavity to be clinically treated.
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DANGER: 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 photosensitizing drugs. In
all cases of possible risk consult a specialized physician.
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DANGER: 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 lter out blue light should be worn).
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DANGER: Contraindications
Patients who have a case history of diseases of the retina should consult their optician beforehand and be
specically authorized to receive treatment with the Silverlight.
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DANGER: Cleaning, disinfection and sterilization of new or repaired products.
Before treatment, all new or repaired products should be cleaned and disinfected and, if suitable for this
treatment, autoclave sterilized following the instructions provided under point “07.0” strictly.