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• NOTE
REGULATIONS
OF REFERENCE
The appliance is manufactured
in compliance with the following
standards:
• Directive 93/42 / EEC, of
June 14, 1993, relating to
medical devices, implemented
with
D.lgs. 24/02/97 n. 46 and its
subsequent modifications.
CEI EN 60601-1 CEI
EN 60601-1-2 CEI
EN 60601-2-5
CEI EN 60601-1-11
CEI EN 14971
DECLARATION
OF CONFORMITY
The company HSD SRL, with
registered and operational
headquarters in SERRAVALLE
(RSM) in Strada Acqusalata, n 11
internal 6, declares, under its sole
responsibility, that the medical
device called risk class IIa in
accordance with rule 9 of the
annex IX of Directive 93/42 / EEC
and subsequent amendments
(implemented in Italy with
Legislative Decree 24 February
1997, n 46 and subsequent
amendments)
• complies with the essential
requirements and provisions of
Directive 93/42 / EEC and
subsequent amendments and
additions. as per the Technical File
filed at the Company;
• is manufactured in accordance
with the Quality System that meets
the requirements set out in Annex V
+ VII of the aforementioned
Legislative Decree, as per the
Certificate issued by BUREAU
VERITAS ITALIA S.p.a. - Notified
Body n. 1370 - Viale Monza, n. 347
- 20126 Milan
• complies with Directive
2011/65 / EU of the European
Parliament and of the Council of
June 8, 2011, on the restriction of
the use of certain hazardous
substances in electrical and
electronic equipment.
• the Authorized European
Representative is Ms Manuela
Corbelli Via Boccioni n. 20-
Morciano di Romagna
The legal representative
Manuela Corbelli
Serravalle (RSM)
EN
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