Kulzer Translux 2Wave Instrucciones De Uso página 43

1 Application
1.1 In general
Mectron S.p.A. is the manufacturer of Translux Wave.
Kulzer GmbH is the distributor.
Translux 2Wave is a registered trademark of Kulzer GmbH.
These operating instructions apply to:
Order no. Type Features
05100082 Translux 2Wave – LED Light curing unit
1.2 EC – Declaration of Conformity
We, Mectron S.p.A., Via Loreto 15/A, 16042 Carasco (GE), Italy, 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 confirm that the unit Translux 2Wave complies with the Regulation EU MDR 2017/745 and the standards
IEC 60601-1 and IEC 60601-1-2.
We hereby confirm that system of Quality Assurance is guaranteed in conformity with the EN ISO 13485.
Carasco (GE), – Mectron S.p.A., Via Loreto 15/A, 16042 Carasco (GE), Italy.
2021-05
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.
Date
2021-08 / 02150702
GB
- 3 -