User's Manual

Spirobank II
Page 30 of 34
Rev.1.1
User manual
Via del Maggiolino 125, 00155 Roma - ITALY
DECLARATION OF CONFORMITY CE
(annex II excluding par.4)
We hereby declare that the following device:
Type Spirometer/Oximeter
Brandname MIR Medical International Research
Device name spirobank II
Class IIa
Complies with the Essential Requirements of directive 93/42/EC concerning Medical Devices, and its amendments, and its
transposition in the Member States.
This statement is made on the basis of the CE Certificate n. MED 9826 issued by Cermet, Notified Body n. 0476.
Rome 01.01.2014
Paolo Sacco Boschetti
The Chairman