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A
ANNEX
This chapter includes all the information and data necessary to provide full knowledge and
interpretation of Falco 202 lung ventilator.
A.1
Technical sheet
GENERAL DATA
NORMS
0476
Class and type according
to IEC 601-1
Class according to 93/42
EEC Directive
Electromagnetic
compatibility (EMC)
Norms
Falco 202
Falco 202 is a lung ventilator conceived for use in home care and transport,
with patients affected by respiratory diseases and it is suitable for ventilation of
adult and paediatric patients.
Falco 202 is equipped with a flow generation system by turbine with separate
cooling system granting higher quality and safety standards in patient
ventilation. The Falco 202 colour display shows the curves of pressure, flow,
volume, the loops of breathing parameters, the trends and the ventilation
parameters.
The lung ventilator is conform to the essential requirements and it is realized
according to the references of the Annex II of 93/42/EEC Medical Devices
Directive.
Class I Type BF
Class IIb
Conform to the requirements of the EN 60601-1-2: 2007 and following
EN 60601-1 :2006/A1 :2011/A1 :2013; EN 60601-1-2 :2015; IEC 601-1-
6:2013; IEC 601-1-8:2012; EN 62304:2006/AC:2008; ISO 10993-1:2009; IEC
62353:2014; EN 60601-1-11:2015; ISO 15223-1:2016; DIR. 2011/65/CE;
D.Lgs 49/2014; ISO 14971:2012; EN ISO 4135:2001
A-1
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