Cosmed Quark CPET, User Manual

Page: 88 / 102

86 - Appendix - Declaration of Conformity
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Declaration of Conformity
Manufacturer: COSMED S.r.l.
Address: Via dei Piani di Monte Savello 37
00041 Pavona di Albano Laziale (RM)
ITALY
phone: +39-06-9315492
fax: +39-06-9314580
Manufacturer of the following equipment:
Quark Spiro
Quark PFT
Quark CPET
Declares under his sole responsibility that:
•
the above listed equipment complies with the essential requirements of the Annex I of the Medical Device Directive 93/42/EEC;
•
are classified in Class IIa;
•
their design, manufacturing and final checks are performed according the Cosmed’s Quality System, conform to ISO 9001:2008 and
ISO13485:2003 Norms, certified by KIWA CERMET (certificates nr. 387-A and 387-M);
•
are CE marked according to the Medical Device Directive 93/42/EEC and subsequent amendments, and certified by KIWA CERMET (certificate
nr. MED 9811).
The equipment conforms to the following specifications:
Safety: IEC 60601-1
EMC: IEC 60601-1-2