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A
ANNEX
This chapter includes all the information and data necessary to provide full knowledge and
interpretation of Falco 101 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
ENVIRONMENTAL CONDITIONS
Operating
Storage
TECHNICAL DATA
Dimensions (W x H x D)
Weight
Electric power supply
Power
Falco 101
Falco 101 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 101 is equipped with a flow generation system by turbine with separate
cooling system granting higher quality and safety standards in patient
ventilation. The Falco 101 colour display shows the curves of pressure, flow
and the trends and the measures 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
updatings.
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
•
Relative humidity : 30 - 95% non-condensing
•
Temperature : from +10 to +40°C
•
Relative humidity : < 95%
•
Temperature : from -25 to +70°C
290 x 245 x 215 mm
5.5 Kg
100 - 240Vac / 50 - 60Hz
Max 60 VA
1
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