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Operator
’
s Manual
MO080-IT
12/09/2017
Rev.3
Page 6 of 20
IEC 60601-1-2
IEC 60601-2-41
1.4
EC Declaration of Conformity of the Manufacturer
The company:
RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20831 SEREGNO (MB) – ITALY
declares under its own responsibility that the Product (Medical device for observation and diagnosis):
APPLY
LABEL
made by RIMSA P.LONGONI S.r.l., 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) (Part 1: Particular
requirements for the safety of surgical luminaires and luminaires for diagnosis)
(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 duration (Annex IX, Par.1 “Definitions”, art.1, subsection 1.1)
DESCRIPTION:
Non-invasive medical device (Annex IX, Par.1 “Definitions”, art.1, subsection 1.2)
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)
Reference to technical file Code RIM-FT023.
The conformity assessment is developed with reference to article 11 of Directive 93/42/EEC and 2007/47/EC.
The RIMSA 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).
The Medical Device to locally light up the patient’s body is marketed in
NON-STERILE
form.
Name: Paolo Longoni
Position: Managing Director
Summary of Contents for PRIMALED SO
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