Gima GIMAled81, Instruction Manual

Page: 107 / 114

OPERATION AND
MAINTENANCE MANUAL
EN
MU_027 Rev.1 29/04/2020 Page 26 of 33
9 Declaration of Conformity of the
Manufacturer
The company:
GIMA S.p.A. Via Marconi, 1 - 20060 GESSATE (MI) – ITALY
declares under its own responsibility that the Product (Medical lighting device for surgical and diagnosis use):
GIMAled81
APPLY
LABEL
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:
•
IEC 60601-1 (Part 1: General requirements for basic safety and essential performance)
•
IEC 60601-2-41 (Part 1: Particular requirements for the safety of surgical luminaires and luminaires for
diagnosis)
•
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 GIMA Quality System complies with UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards and is certified by Kiwa
Cermet Italia (certificate no. 10164-A and 10164-M).
Name: Nicola Manzoni
Position: General Manager