Kulzer Translux 2Wave Instrucciones De Uso página 46

WARNING
Adopt strict safety measures for patients who have undergone cataract surgery and are therefore particularly
sensitive to light (for example, safety glasses that filter out blue light).
All models of curing lights are intended for professional use only. Therefore, the user is the only person able to decide if
and how to treat their patients.
WARNING
Contraindications. In all cases of potential risk, a specialist doctor must be consulted.
3.1.3 Indications for use
The use of the device is indicated for all the intended patients (see Chapter 3.1.1) for whom a polymerization treatment
of light-curing dental materials is prescribed, by the treating physician, within the intended use of the device (see
Chapter 3).
3.1.4 Users
The device must be used only by specialised and properly trained personnel, such as the dentist and/or assistant, adults
of any weight, age, height, gender and nationality, able-bodied. No specific training activities are required for the use of
the device.
GB
3.2 Safety requirements
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The effectiveness of the safety instructions with regard to personnel protection, handling the unit and handling the
processed product is to a large degree dependent on the behaviour of the staff working with the equipment.
WARNING
Prior to initial operation, carefully read through these Operating Instructions and observe the information
in order to avoid errors and subsequent damage, particularly damage to health.
In addition to the instructions in this operating manual, comply with the national laws, regulations,
and directives in your country when setting up and operating the unit.
3.2.1 General safety instructions on operating the device
WARNING – INTENDED USE
Use the unit only for the purpose for which it is intended (see paragraph 3 Intended use). Any other uses are
strongly contra-indicated. Any non-compliance of this regulation can result in serious injury of the patients
or operators of the unit as well as damage or faults to the unit. Mectron S.p.A. is not liable for consequential
damages due to the non-observance of the aforementioned provision!
WARNING
The user is responsible for testing the Translux 2Wave for its use and suitability for the intended purposes.
Never point the light towards the eyes! Direct or indirect exposure of light into the eyes must always be
prevented by wearing protective goggles that filter out blue and ultraviolet light. When curing, position the light
guide tip directly over the material that needs to be cured and avoid extraneous exposure to soft tissues.
Eyes, gums, soft tissue and other body parts must not be exposed to the light beam (if necessary, these parts
must be covered with protection). Use a rubber dam to protect the soft tissues, i.e. gingiva during treatment.
Exposure must be restricted to the area of the oral cavity in which clinical treatment is executed.
WARNING – CONTRA-INDICATIONS
Do not use the Translux 2Wave on patients fitted with a pacemaker or other implantable electronic devices.
This also applies to the operator.
The unit must not be used by children, the blind or the deaf and also not by / on persons who are prone
to possible epileptic seizures. The above pre-named persons may not recognise the risks of use and operation.
Due to safety reasons for the operator and the patients with potential risk of epileptic seizures, use and
operation of the device is prohibited.
WARNING
No modification of this equipment is allowed.
The owner / user must ensure that:
– The unit is not used on patients with a positive anamnesis after light testing, for example with urticaria
solaris and / or porphyria as well as on patients who have been treated with photosensitising medication.
– The unit is not used on patients that have had surgery for eye cataracts, which are particularly sensitive
to light, unless they use suitable protective measures, such us the use of eye protectors / spectacles that
filter out blue and ultraviolet light.
– Patients whose anamnesis includes retinal diseases must have treatment with Translux 2Wave authorised
by their ophthalmologist.