I-Tech UE, User Manual

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IACER Srl 6 MNPG118-02
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defective power supply;
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improper maintenance;
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unauthorized modifications and interventions;
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use of material or spare parts that are not specific for the model;
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partial or complete non-observance of the instructions supplied;
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exceptional events.
To get further information, consult the fabricant.
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. 041.5401356 • Fax 041.5402684
IACER Srl. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/235-2020 from the Notified Body n° 0068 MTIC InterCert S.r.l.).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the product
I-TECH UE
UMDNS Code : 17908
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as modified
by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations. The product has been assigned to class IIa,
according to Annex IX, rule 9 of the Directive 93/42/EEC (and further
modifications/integrations) and bears the mark
Compliance of the concerned product with the Directive 93/42/EEC has been
assessed and certified by the Notified Body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certificate no.: 0068/QCO-DM/235-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON Martellago, 03/08/2020