- 6 -
GB
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
fi lter out blue and ultraviolet light.
– Patients whose anamnesis includes retinal diseases must have treatment with Translux 2Wave authorised
by their ophthalmologist.
– A specialist doctor is consulted in all potential risk cases.
WARNING – Temperature of applied parts
Max. temperature of the applied parts (light guide and protective light cone): 41°C (106°F).
Max. temperature of the part considered as applied part (metal front cone) as it can come into contact with the
patient: 46°C (115°F).
Kulzer declares that if the device is used in conformity with the instructions contained in this manual, no tissue
heating will occur.
WARNING – Control of infections.
The light guide and the protective light cone must be cleaned, disinfected and sterilised (steam) before every
use. The light guide and the protective light cone are delivered in
NON
STERILE
condition and must be sterilised
before being used for the fi rst time. See paragraph 8.4.1.2 Sterilisation parameters.
3.2.2 Safety
Precautions
WARNING – RISK OF EXPLOSION
Do not
install the device where there is the risk of explosions.
The device must not be used where an infl ammable atmosphere is present (anaesthetic mixtures, oxygen,
nitrous oxide, etc.). Use the device in a well ventilated area.
WARNING
Before using the unit, check the mains power cable and plug for damage. If they are damaged, do not connect
the unit to the mains.
Use only original spare parts or accessories from Kulzer GmbH. Kulzer provides a light guide suitable for use
with the Translux 2Wave. Other light guides must not be used. Kulzer GmbH will not accept any liability for
damage resulting from the use of non original Kulzer spare parts or accessories.
3.2.3
BATTERY – Safety precautions
Kulzer GmbH assumes no liability for battery problems that occur when the Safety Precautions listed in the paragraph
below are not carefully adhered.
WARNING
Misusing the battery may cause the battery to get hot, rupture, or ignite and cause serious injury.
Be sure to follow the safety rules listed in the below paragraph.
Use original Kulzer batteries only!
The use of non Kulzer batteries or non-rechargeable batteries and / or primary batteries is a potential danger
and can damage the device.
Keep the battery out of the reach of children!
Never
open, puncture or crush the battery – it contains poisonous substances.
If the battery shows corrosion, emits an unusual smell, or loss of fl uids, remove the battery from the hand piece
immediately.
Do not
expose the battery to water or salt water, or allow the battery to get wet. Do not store the battery in high
humidity or in a place which may expose the battery to rain.
In the event that the battery leaks and the fl uid gets into one’s eye, do not rub the eye. Rinse well with water
and immediately seek medical care. If left untreated the battery fl uid could cause damage to eye.
WARNING – RISK OF EXPLOSION
Use only the Translux 2Wave charging unit and the input power supply, which are provided with the unit,
to charge the hand piece’s battery. Never attempt to charge the Translux 2Wave battery by using any
other charging unit. The use of any other charging unit can result in the damage of the battery, risk of explosion
and fi re!
Never
use the Translux 2Wave recharging unit to charge other types of battery or other units with
a rechargeable battery! Use only original batteries from Kulzer.
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