Ce Declaration Of Conformity - Zhermack zetaclave B Manual De Uso Y Mantenimiento

MAINTENANCE AND USE MANUAL
The Manufacturer:
Zhermack S.p.A.
Via Bovazecchino, 100
45021 Badia Polesine • RO • Italy
Tel. +39 0425 597 611 • Fax +39 0425 53 596
declares under its sole responsibility that the product:
is in conformity with Directive 2011/65 EU of the European Parliament and of the Council of 8 June
2011 on the restriction of the use of certain hazardous substances in electrical and electronic
equipment.
It is also in conformity with the laws implementing the following directives:
· EC Directive 2004/108 EC (EMC Directive) and subsequent amendments.
· EC Directive 2006/95 (Low Voltage Directive) and subsequent amendments.
Medical devices:
EC Directive 93/42 - class IIb
Pressure tool:
EC Directivea 97/23.
Zhermack S.p.A. prohibits the use of the medical device referred to in this declaration for purposes
other than those indicated in the INSTRUCTION MANUAL.
The device is designed and manufactured in compliance with the basic requirements prescribed in
annex I to Legislative Decree no. 46/97 (annex I to Directive 93/42/EEC). When designing and
manufacturing this device, best practice standards have been followed:
UNI CEI EN ISO 14971:2012
Medical devices: application of risk management to medical devices.
NOTIFIED BODY
TÜV SÜD (n° 0123). The process chosen for the Evaluation of conformity is as per Annex II to Directive
93/42/EEC.
Please note that the manufacturer's liability for damages caused by a defective product expires 10
years from the date on which the manufacturer released such product on the market and that such
liability is transferred to the user in accordance with Directive 85/374/EEC, subsequent amendments
and the laws implementing it.
Badia Polesine, 25/02/2014
zetaclave B
EN
Model / Serial Number
Zetaclave B
DECLARATION OF CONFORMITY CE
Person authorised to compile the technical file:
Zhermack S.p.A.
Via Bovazecchino, 100
45021 Badia Polesine • RO • Italy
Tel. +39 0425 597 611 • Fax +39 0425 53 596
A.1
Lt.
18
23
Paolo Ambrosini
General Manager
177 of 228