Aannex; Technical Sheet; A.1 Technical Sheet - Siare Falco 202 Evo User Manual

A ANNEX
This chapter includes all the information and data necessary to provide full knowledge and
interpretation of Falco 202 Evo (10.4") 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 Evo
FALCO 202 EVO 10" electronic lung ventilator is equipped with turbine
and with a TFT 10,4" colour monitor touch screen displaying the curves
of pressure, flow, volume, the loops of breathing parameters, the trends
and the ventilation parameters. FALCO 202 EVO 10" lung ventilator is
suitable for ventilation of adult, paediatric and neonatal patients. FALCO
202 EVO 10" lung ventilator is equipped with a flow generation system by
turbine with separate cooling system granting higher quality and safety
standards in patient ventilation.
FALCO 202 EVO 10" is equipped with a flow and pressure trigger, it
provides the most advanced volume-controlled ventilation modalities
VC/VAC, VC/VAC-BABY, pressure-controlled ventilation modalities
APCV (BILEVEL ST), APCV-TV, SIMV by Volume and by Pressure,
Pressure supported modalities PSV (BILEVEL S), PSV-TV, CPAP,
APRV, SIGH, Non-Invasive Ventilation (NIV APCV - NIV PSV), Drug
Nebulizer and Manual Ventilation (MAN).
FALCO 202 EVO 10" is supplied with back up long lasting batteries and
its software can be updated for new modes and last generation
ventilation strategies.
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 B
Class IIb
EN 60601-1-2: 2015 and following
DIR. 93/42/CEE (2007); EN 60601-1 :2006/A1 :2011/A1 :2013; EN
60601-1-2 :2015; IEC 601-1-6:2013; IEC 601-1-8:2012; EN 60601-2-
12:2007; ISO 80601-2-12:2011; EN 62304:2006/AC:2008; ISO 10993-
1:2009; IEC 62353:2014; ISO 15223-1:2016; DIR. 2011/65/CE; D.Lgs
49/2014; ISO 14971:2012; EN ISO 4135:2001
A-1