Kulzer 05100081 Instructions For Use Manual Download

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– Patients whose anamnesis includes retinal diseases must have treatment with Translux Wave 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).
Mectron S.p.A. 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 first time. See paragraph 8.4.1.2 Sterilisation parameters.

WARNING

If an adverse event and/or serious incident attributable to the device occurs during correct and intended use, it

is recommended to report it to the Competent Authority and to the manufacturer indicated on the product label.

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

inflammable 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.
Kulzer GmbH will provide only original spare parts or accessories supplied by Mectron S.p.A. .

Mectron S.p.A. will not accept any liability for damage resulting from the use of non original spare parts or

accessories.

3.2.3 BATTERY – Safety precautions

Mectron S.p.A.

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 batteries only!

Kulzer GmbH will provide only original batteries supplied by Mectron S.p.A. .

The use of non original 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 fluids, 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 fluid gets into one’s eye, do not rub the eye. Rinse well with water

and immediately seek medical care. If left untreated the battery fluid could cause damage to eye.

WARNING – RISK OF EXPLOSION

Use only the Translux Wave 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 Wave 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 fire!

Never

use the Translux Wave recharging unit to charge other types of battery or other units with a rechargeable

battery! Use only original batteries.