mectron starlight s +, Installation Manual

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5
iNtrODUCtiON
Risk Group 2
CAUTION. Possibly hazardous optical
radiation emitted from this product.
Do not stare at operating lamp. May
be harmful to the eye
Product tested against IEC62471
Figure 1 – Photobiological safety
WARNING: Cleaning, disinfection and sterilisation of new or repaired products.
Before treatment, all new or repaired products should be cleaned and disinfected and, if
suitable for this treatment, autoclave sterilised following the instructions provided in
Chapter 5
on page 10
of the Use and Maintenance manual strictly.
WARNING: Infection control.
In order to ensure maximum safety for both the patient and the operator, clean, disinfect
and sterilise the optical fibre and the optical protection before each treatment. Follow the
instructions provided in
Chapter 5 on page 10
of the Use and Maintenance manual.
WARNING: Use only original Mectron accessories and spare parts.
WARNING: Checking the condition of the device before treatment.
Before each treatment always check that the equipment is in proper working order and that
the accessories are efficient. Do not carry out the treatment if any problems are encountered
in operating the equipment. if the problems concern the equipment contact an authorised
technical service centre.
WARNING: Risk of explosions.
the equipment cannot operate in environments where there are saturated atmospheres of
flammable gases (anaesthetic mixtures, oxygen, etc.).
CAUTION: In case the final user, operating in their own medical room or surgery, in order
to comply with mandatory requirements, must periodically inspect the equipment present
in the surgery, the test procedures to apply to medical electrical equipment and medical
electrical systems for the safety assessment must be carried out following the standard EN
62353 ‘Medical electrical equipment - Periodic inspections and tests to be carried out after
repair of medical electrical equipment’. The interval for periodic checks, in the intended
operating conditions and described in this “Use and Maintenance” manual, is one year or 2000
hours of use, depending on which of these two conditions occurs first.
WARNING: if an adverse event and/or serious incident attributable to the device occurs
during correct and intended use, it is recommended to report it to the Competent Authority
and to the manufacturer indicated on the product label.