15 Déclaration De Conformité Ce; Ec Conformity Declaration - Linet Eleganza Smart Manuel D'utilisation Et Documentation

15 Déclaration de Conformité CE

EC CONFORMITY DECLARATION

Date of issue: 12. 11. 2011
Conformity declaration issued by:
Commercial name
Registered address
Reg. No.
Telephone
Fax
As the producer of the product - name
(brand):
Variants of the product:
Description and function designation:
Classification of the product as the medical
device:
A) Declaration
I declare that the said product is safe under the conditions of common use in compliance with the instructions
and that measures have been taken to ensure the conformity of all the products brought to market with basic
requirements of directives related thereto, stated in paragraph B.
B) Fulfilled technical requirements
This product's characteristics comply with the technical parameters related to it and stated in MDD 93/42/EEC
as amended which stipulates the technical parameters for healthcare products, in directive 2004/108/ES as
amended which stipulates the technical parameters of products concerning their electromagnetic compatibility
and directive 2006/42/EC as amended which stipulates the technical parameters for machinery device.
C) Means of assessing conformity
Conformity was assessed by the procedure stated MDD 93/42/EHS, Annex VII
D) Used standards
The said product fulfils the requirements of these harmonized technical standards which were used for
assessing of conformity: EN ISO 60601-1: 1994, EN ISO 60601-1-2: 2003, EN ISO 60601-1-4:1998, IEC
60601-2-52:2009 and EN ISO 1970:2001.
Ing. Zbyn k Frolík
managing director
Produit: Eleganza Smart
Version: 03
Linet spol. s r. o.
Želev ice 5, 274 01 Slaný, Czech Republic
00507814
+420 312 576 111
+420 312 522 668
ELEGANZA SMART
1SMA
(Variants are specified in the technical documentation of the
product).
Electrically operated hospital bed intended for use in the standard
care, acute care and long term care.
This EC conformity declaration also covers all applicable
accessories.
Class I nonsterile, without measuring function
53/62