Ancar TD-700 사용자 설명서 - 페이지 3
{카테고리_이름} Ancar TD-700에 대한 사용자 설명서을 온라인으로 검색하거나 PDF를 다운로드하세요. Ancar TD-700 18 페이지. Dental stools
페이지 인쇄USER MANUAL
EC Declaration of Conformity (Directive 93/42/EEC, annex VII)
Manufacturer's Name
ANTONI CARLES, S.A.
With medical device manufacturing and assembly license number 2509-PS granted by the Health
Authorities of Spain
Name of device
Dental Stool
Code GMDNS: 11164
Intended use:
Equipment to facilitate support and height adjustment to user provided with casters,
and with or without backrest.
Device Class According to the intended use and the criteria of Annex IX of the Directive:
Class I (rule 12).
Scope of Application: All (including pieces and accessories)
This Declaration is based on Certificates issued by DNV:
# 171338-2015-AQ-IBE-NA, according to ISO 13485:2003 / NS-EN ISO 13485:2012.
# 171281-2015-AQ-IBE-ENAC, according to ISO 9001:2008
We, the undersigned, under our sole responsibility, certify and declare that the medical devices specified
above are in conformity with the essential requirements, which are applicable to them, of RD 1591/09,
transposition to the Spanish law of the directive 93/42/EEC, as it has been modified by 2007/47/EC. We
also declare that we comply with the design and construction requirements of the following standards:
ISO 7493:2006
EN ISO 14971 :2012
We also declare constructive materials fulfill RD 219/13, transposition law of the directive RoHS II
(2011/65/EU).
Authorized Signatory
Josep Álvarez
Regulatory & Safety Officer
Antoni Carles, S.A.
Volta dels Garrofers, 41-42
Pol. Ind. Els Garrofers
08340-Vilassar de Mar
(Barcelona-SPAIN)
Dentistry. Operator's stool
Medical Devices. Application of Risk Management to Medical Devices.
ANTONI CARLES BOSCH
Antoni Carles Bosch
General Manager
DENTAL STOOLS - QS4-692-01 / TD-700/600/500
T. (34) 93 754 07 97
F. (34) 93 759 26 04
www.ancar-online.com
Type or Model:
TD-500 / TD-600 / TD-700
ANTONI CARLES, S.A.
Pol. Ind. "Els Garrofers"
C/Volta dels Garrofers, 41-42.
08340 VILASSAR DE MAR
BARCELONA-SPAIN
29 September 2015
Stamp, Date
3