Application; In General; Ec - Declaration Of Conformity; Manufacturer's Declaration - Kulzer Translux 2Wave Mode D'emploi

1

Application

1.1

In general

Translux 2Wave is a registered trademark of Kulzer GmbH.
These operating instructions apply to:
Order no. Type Features
66055013 Translux 2Wave – LED Light curing unit
1.2 EC – Declaration of Conformity
We, Kulzer GmbH, Leipziger Straße 2, 63450 Hanau, hereby declare that the design, structure and version introduced
to the market of the unit described below correspond to the relevant safety and health requirements of the EU Directive.
This declaration shall become invalid in the event of an alteration made to the unit without our prior authorisation.
1.3

Manufacturer's declaration

We hereby confi rm that the unit Translux 2Wave complies with the directive 93/42 EC and the standards IEC 60601-1
and IEC 60601-1-2.
We hereby confi rm that system of Quality Assurance is guaranteed in conformity with the EN ISO 13485.
Hanau, 2017-07 – Kulzer GmbH, Leipziger Straße 2, 63450 Hanau (Germany).
2

Instructions on using the unit safely

Please read this manual and follow its instructions carefully. The words WARNING, CAUTION and NOTE carry special
meanings and must be carefully reviewed (see the following paragraph). Always keep this manual within easy reach.
2.1

Explanation of symbols and accompanying word(s)

Symbols Accompanying word(s)
WARNING
CAUTION
NOTE
WARNING OF
EXPLOSION
DISCONNECT FROM
MAINS
NEMKO
WEEE / ElektroG
Explanation
Implies that death or serious injury could occur if the advice is not followed.
Implies that minor injury or device damage could occur if the advice is not
followed.
Implies advice that is not related to harm.
WARNING of explosion – observe information and warnings in the chapters
and sections marked with the following pictorial symbols.
WARNING of electric shock.
Before carrying out the cleaning and disinfection procedures disconnect
the charging base from the electrical power source!
Nemko mark – UL / CSA conformity.
Disposal of old equipment according to WEEE (European Directive) or
Electrical and Electronic Equipment Act (German Law ElektroG).
Applied part:
Type B applied part-in conformity with technical standards IEC 60601-1.
Double insulation:
Class II device.
Power supply:
Alternate current.
Direct current.
Switching power supply plug polarity – Centre positive.
Use in closed spaces only.
Date
2017-07 / 99000873/11
GB
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