Technical Sheet; Siaretron 4000 - Ventilator For Intensive Care - Code 960401 - Siare Siaretron 4000 User Manual

A.1 Technical sheet
A.1.1 Siaretron 4000 - Ventilator for Intensive Care - code 960401
GENERAL DATA
Optional Medical air compressor for trolley mounting.
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
A-2
Siaretron 4000 electronic lung ventilator is equipped with a TFT 12" colour
monitor displaying the curves of pressure, flow, volume, the loops of
breathing parameters, the trends and the ventilation parameters.
Siaretron 4000 lung ventilator is suitable for ventilation of adult, paediatric
and neonatal patients (optional).
Siaretron 4000 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 (NEB) and Manual Ventilation (MAN).
Siaretron 4000 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/CEE Medical Devices
Directive.
Class I Type B
Class IIb
Conform to the requirements of the 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 62304:2006/AC:2008; ISO
10993-1:2009; IEC 62353:2014; EN 60601-2-12:2007; ISO 80601-2-12:2011;
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
User manual, DU3065104