Tecno-gaz ORION TECH, Operation And Maintenance Manual

Page: 64 / 156

Operation and
maintenance manual
MU_029_EN 07/11/18
EN
Rev.0 Page 26 of 35
The company:
TECNO-GAZ S.p.A. Strada Cavalli n. 4 - CAP 43038 - Sala Baganza - Parma - ITALY
declares under its own responsibility that the Product (Medical lighting device for surgical and
diagnosis use):
ORION TECH
APPLY
LABEL
made by TECNO-GAZ S.p.A, complies with Annex VII of Directive 93/42/EEC dated 14/05/1993,
enforced in Italy by Legislative Decree No. 46 dated 24 February 1997 and subsequent
amendments (including Directive 2007/47/EC dated 05/09/2007, enforced in Italy by Legislative
Decree No. 37 dated 25 January 2010) and with the following standards:
•
EN/IEC 60601-1
(Part 1: General requirements for basic safety and essential performance)
•
EN/IEC 60601-2-41
(Part 1: Particular requirements for the safety of surgical luminaires and
luminaires for diagnosis)
•
EN/IEC 60601-1-2
(Part 2: General requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements and tests)
Classification with reference to article 9 and Annex IX of Directives 93/42/EEC and
2007/47/EC
DURATION: Short term (Annex IX, Par.1 “Definitions”, art.1, subsection 1.1)
DESCRIPTION: DESCRIPTION: Non-invasive medical device (Annex IX, Par.1 “Definitions”,
art.1, subsection 1.2)
DESCRIPTION: Active medical device (Annex IX, Par.1 “Definitions”, art.1,
subsection 1.4)
CLASS I: (Annex IX, Par.3 “Classification”, art.3, subsection 3.3, Rule 12) and
(Annex IX Par.3 “Classification”, art.1, subsection 1.1 Rule 1)
•
The conformity assessment is developed with reference to article 11 of Directive 93/42/EEC
and 2007/47/EC.
•
The TECNO-GAZ Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO
13485 standards and is certified by CSQ (CSQ certificate no. 9120.RMS1 and 9124.RMS2).
Name: PAOLO BERTOZZI
Position: Managing Director
9 Declaration of Conformity of the
Manufacturer