Machine Journal; Intended Use; Description Of The Device; Patient Group Directions - KULZER Translux Wave Gebrauchsanweisung

2.4

Machine journal

We recommend that you keep a " machine journal " and document all tests and major work (e.g. servicing, changes) in it.
3

Intended use

The Translux Wave is a LED dental curing light unit intended for use in the oral cavity for the polymerisation
of light curing dental materials such as adhesives and filling materials that are activated in the 440 – 480 nm wave-
length range.
NOTE
Although most light curing dental materials are activated within this wavelength range, in case of uncertainty,
verify the manufacturer's specifications or contact the manufacturer.
WARNING – Qualified and specialised personnel.
The device must be used exclusively by specialized personnel with appropriate medical background; no training
activities for the use of the device are foreseen by Mectron S.pA. . The use of the device does not cause side
effects if it is used correctly.
3.1

Description of the device

The Translux Wave uses a source of light consisting of a very-efficient mono-chromatic LED diode with a wavelength
comprised between 440 and 480 nm.
The entire light radiated by the Translux Wave is used to activate the camphorquinone photoinitiator. This produces
excellent polymerisation results with low heat emission.
The Translux Wave is shipped with a 360° rotating light guide with 8 mm diameter.
The Translux Wave consists of a charging unit and a hand piece, powered by a removable rechargeable
Lithium-ion battery.
The hand piece is equipped with a " Sleep Mode " to minimise the unit's energy consumption.
The hand piece switches to " Sleep Mode " if it is not used for a period of about 5 minutes.
The Translux Wave can operate with two different exposure cycles:
• Exposure with constant output: cycle duration 10 seconds.
• Exposure with slowly increasing output : " Soft-Start " (cycle duration 20 seconds).
The " Soft-Start " means increase of light intensity from 50% up to 100% within 2 seconds.
NOTE – Observe the exposure times of the materials specified by the manufacturer.
For materials with specific exposure times (e.g. 30 / 40 seconds for dark composites) repeat the exposure
several times if necessary.
3.1.1

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.
3.1.2

Patient selection criteria

The use of the device is not recommended in the following cases:
• Patients with active implantable medical devices (for example: pacemakers, hearing aids and/or other electromagnetic
prostheses) without the prior authorization of their doctor;
• 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;
• Patients whose medical history shows pathologies of the retina must first consult the ophthalmologist to receive
authorization for treatment with the Mectron S.p.A. curing light.
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