I-Tech MIO-CARE PRO, User Manual

Page: 4 / 36

IACER S.r.l. 4 of 36 MNPG148 Rev. 02 02/07/15
Technical
Specifications
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
IACER S.r.l. is an Italian medical devices manufacturer (CE medical certificate n° MED24021 issued
by Cermet notified body n°0476).
Declaration of Conformity
IACER S.r.l., headquartered in Italy, via S. Pertini 24/A 30030 Martellago (VE), declares on its own
responsibility that MIO-CARE PRO is manufactured in conformity with Directive 93/42/EEC
(MDD) dated 14 June 1993 (D. Lgs. 46/97 dated 24 February 1997 “Attuazione della Direttiva
93/42/CEE concernente i dispositivi medici), Annex II as modified by Directive 2007/47/CE dated
5 September 2007 (D. Lgs. 37/2010 dated 25 January 2010).
Notified body: Cermet, Via di Cadriano 23 – 40057 Cadriano di Granarolo (BO) Italy.
MIO-CARE PRO is a Class IIa equipment, with reference to Directive 93/42/EEC (MDD), annex
IX rule 9 (and following modifications).
Certification Path: Annex II
Martellago, 01/07/2014 Legal Rappresentative
Mario Caprara
Specifications
MIO-CARE PRO has the following specifications:

Class IIa equipment (Directive 93/42/CEE, Annexed IX, rule 9 and following modifications);

Class II applied part type BF (Classif. CEI EN 60601-1);

Equipment not protected against liquid penetration;

Equipment and accessories not subjected to sterilization;

Use of the equipment is prohibited close to flammable substances when mixed with air or with
oxygen or with nitrous oxide;

Continuous operating mode equipment;

Equipment not suited to be used in external.