DKL L2-S300, Руководство по эксплуатации, Страница: 200 / 327

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1.1 — Any unauthorised tampering, modification or
improper use immediately terminates the warranty and
exonerates our company from all liability for injury or damage
to persons, animals or property that may be caused by such
interference.
1.2 — To ensure maximum user and patient safety, the
transformer used must be rated Safe Extra Low Voltage
(SELV) with CE marking for medical use, in compliance with
IEC 80.601 and IEC 60.601.
1.3 — Connection to terminals with output voltage
exceeding 24 V could irreparably damage the device.
1.4 — The stress absorber cord must be anchored to the
dental unit. This cord is designed to absorb any strains, thus
preventing abnormal traction on the electrical or air/water
line connections.
1.5 — Before use, the electric, water and air lines must be
correctly connected. The syringe could be damaged if used
when not connected to the water and air supplies. The lines
must be connected correctly since inverting them would
damage the syringe.
1.6 — To meet the requirements of Directive 93/42/EEC,
the company has established a post-marketing surveillance
procedure to monitor any problems generated by the use
of our products. The attached form allows you to report any
faults and suggest improvements which will be considered
for subsequent versions of the product.
1.7 — With each syringe, the package also includes a User’s
manual which also includes a “Fault Report Form”. Since this
is required by law, the user must receive this User’s manual.
Therefore, the syringe installer is responsible for delivering
this User’s manual to the dentist. Directive 93/42/EEC
requires product traceability: therefore, our customers are
asked to ensure that, in case of emergency, we can identify
the end customer to whom the product has been sold.
1.8 — Manufacturers and/or installers of dental units are
required to comply with all the prescriptions outlined in this
document.
1.9 — Use the Minilight syringe only for the applications
described in the instructions for use.
1.10 — This product must only be installed by qualified
persons.
1.11 — Never modify the syringe in any way. This is strictly
forbidden.
1.12 — Use only original parts produced or approved by
the manufacturer. If non-OEM accessories or consumables
are used, the company cannot guarantee safe operation and
function. No claims can be made for damages resulting from
improper use.
1.13 — Disposable tip adapters are not part of the Minilight
Syringe and may compromise proper functioning.
2.1 — GENERAL
The Minilight syringe is a medical device designed to blow
air and water (separately or together, at room temperature
or at body temperature) to clean and/or dry the oral cavity
during any dental procedure. It has been designed for use in
dentist offices and dental clinics and is built into dental unit
used exclusively by dentists. Product life — under proper
maintenance conditions — is 5 years.
2.2 — GENERAL CHARACTERISTICS
• The Minilight syringe is a medical device for dental use
(class II a).
• Protection rating against direct contacts: B
• Temporary operation: 10 sec. ON/ 20 sec. OFF.
The Minilight syringe has been designed using the latest
ergonomic concepts for easy use and immediate cleaning
and sterilisation. Both the tip and handpiece can easily be
removed for perfect autoclave disinfection and sterilisation
at 134°C (see point 8). Several handpieces of different shape
are available. Choose the shape you need: angled or stylet.
The air and water can also be heated to body temperature,
thus sparing the patient even the slightest discomfort
induced by insufflation of products at ambient temperature.
2.3 — MODELS
The models are differentiated into versions based on the
1 —— WARNINGS
2 —— PRODUCT DESCRIPTION
1.14 — Do not use the device in close contact with
anaesthetic gases or in highly oxygenated environments (with
an oxygen content >25%) or in areas where there is a risk of
explosion.
1.15 — Do not perform any maintenance procedures not
indicated in the manual.
1.16 — Before using the syringe, make certain that the
water and air supplies have been activated.
1.17 — National regulations regarding dental unit water
and air quality must be met.
1.18 — The air used must be dry, clean and free of oil.
1.19 — The Minilight syringe meets the requirements laid
out in European Council Directive 93/42/EEC: Class II A
1.20 — The Minilight syringe must not be used near or set
on other devices.
1.21 — Use only accessories, cables, transducers specified
or supplied by Luzzani Dental.
1.22 — Do not use mobile RF communication devices
within a distance less than 30 cm from the device.