Heraeus Kulzer Translux Power Blue, Instructions For Use Manual

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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.
3.2 Safety requirements
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. Heraeus Kulzer is not liable for consequential
damages due to the non-observance of the aforementioned provision!
WARNING
The user is responsible for testing the Translux Wave 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 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 blue light (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 Wave 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 light.