Cosmed microQuark, Руководство пользователя

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
D
eclaration of conformity
Manufacturer: COSMED S.r.l.
Address: Via dei Piani di Monte Savello 37
00041 Albano Laziale (RM)
ITALY
phone: +39-06-9315492
fax: +39-06-9314580
manufacturer of the following equipment:
microQuark
declares under his sole responsibility that:
•
the above listed equipment comply 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 CERMET (certificates nr. 387-A and 387-M);
•
are CE marked according to the Medical Device Directive 93/42/EEC and certified by CERMET (certificate nr. MED 9811).
The equipment conform with the following specifications:
Safety: IEC 60601-1
EMC: IEC 60601-1-2
32 - Appendix - Dichiarazione di conformità