FALCO 202 Evo

Intensive care and transport ventilator

Turbine driven - Adults, Paediatric, Newborns

Code: 980209
rev.3 - 03/03/2016

GENERAL DATA

Falco 202 Evo is a lung ventilator conceived for use in emergency rooms,
transport, intensive care units, and with patients affected by respiratory
diseases and it is suitable for ventilation of adult, paediatric and neonatal
(optional) patients.

Falco 202 Evo 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 Evo’s colour display shows the curves of pressure,
flow, volume, loops of breathing parameters, trends and other ventilation
parameters.
The Falco 202 Evo is equipped with 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, SIGH, Non Invasive Ventilation (NIV), Drug
Nebulizer and Manual Ventilation (MAN).

NORMS

The lung ventilator conforms to the essential requirements and it is realized

0476 according to the references of the Annex II of 93/42/EEC Medical Devices
Directive.

Class and type according Class 1 Type B

to IEC 601-1

Class according to 93/42 Class IIb

EEC Directive

Electromagnetic Conforms to the requirements of the IEC 601-1-2 norm.

compatibility (EMC)

Norms IEC 601-1, IEC 601-1-2, IEC 601-1-4, IEC 601-1-8, IEC 601-2-12,
EN 1281-1, EN 794-3, UNI EN 4135.

Falco 202_EVO_980209-GE_te_rev3.1.doc 1/8

ENVIRONMENTAL CONDITIONS
Operating Relative humidity : 30 - 95% non-condensing
Temperature : from +10 to +40°C
Storage Relative humidity : < 95%
Temperature : from -10 to +60°C

TECHNICAL DATA

Dimensions (W x H x D) 266 x 244 x 174 mm

Weight 5.5 Kg

Electric power supply 100 ÷ 240Vac / 47 ÷ 63Hz

Power Max 150 Watt

External power supply (low 12 Vdc / 7 A

tension)

Internal battery Battery NiMh 12Vcc – 4.5 Ah

Internal battery operation Max 4 hours

Battery re-charging time About 24 hours

External electric RJ for O2 cell connection
connections

Electric external connections RS232 for CO2 module; USB for PC connection (transfer patient data,
(optional) events, trends)

Patient connections Male conic connectors 22 mm / Female of 15 mm (according to EN 1281-1

norm)

Supply pressure (O2 ) Low pressure (max 15 l/min)

High pressure 280 kPa - 600 kPa / 2.8 - 6 bar / 40 – 86 psi

Max flow requested (O2 ) 80 l/min (minimum)

IP degree of protection IP54

Falco 202_EVO_980209-GE_te_rev3.1.doc 2/8

LUNG VENTILATOR FUNCTIONAL FEATURES
Use destination Falco 202 Evo is a lung ventilator for use in emergency rooms, transport,
intensive care units and with patients affected by respiratory diseases and it
is suitable for ventilation of adult, paediatric and neonatal (optional) patients.

Operation principle  Time cycled at constant volume

 Pressure cycled
 Microprocessor controlled flow
 Spontaneous breath with integrated valve

Pressure automatic Automatic compensation of atmospheric pressure on measured pressure:

compensation present

Dead space compensation Automatic compensation of mechanical and patient circuit dead space

Automatic leaks Max 60 l/min

compensation

Ventilation modalities  APCV (BILEVEL ST), APCV-TV, PSV (BILEVEL S), PSV-TV
(AutoWeaning), VC/VAC, VC/VAC BABY, V SIMV+PS, P SIMV+PS
SPONT, CPAP, APRV
 SIGH, NEB, Apnoea BACK-UP, NIV, MANUAL.

Breathing rate VC/VAC From 4 to 150 bpm

 Ti min = 0.036sec (minimum inspiratory time)

 Ti max = 9.6sec (maximum inspiratory time)

Inspiratory Time / Expiratory
Time (maximum, minimum)
 Te min = 0.08sec (minimum expiratory time)

 Te max = 10.9sec (maximum expiratory time)

Breathing rate From 1 to 60 bpm

V-SIMV e P-SIMV

SIMV Inspiratory time From 0.2 to 5.0 sec.

Tidal volume from 20 to 3000 ml (from 20 to 350 ml in VC/VAC BABY mode)

from 5 to 350 ml in VC/VAC BABY mode (optional)

I:E ratio From 1:10 to 4:1

Inspiratory pause From 0 to 60 % of the inspiratory time

Inspiratory pressure limit PLIM : from 2 to 80 cmH2O (in function of low and high pressure alarm set)

Inspiratory ramp slope 1, 2, 3, 4 (acceleration slope) - (4 max. acceleration) (in operative modes by
pressure only)

PEEP From OFF, 1 to 50 cmH2O

Falco 202_EVO_980209-GE_te_rev3.1.doc 3/8

 PEEP adjustment Microprocessor controlled valve

O2 concentration Adjustable from 21 to 100% with electronic integrated mixer.

Trigger detective method Through sensor (pressure or flow)

Pressure trigger ( I ) By adjustable pressure from OFF; -1 to -20 cmH2O under PEEP level
 from -1 cmH2O to -20 cmH2O : step of 1 cmH2O

Flow trigger ( I ) Flow adjustable from OFF; 0.3 to 15 L/min

 from 0.3 to 1 L/min: step of 0.1 L/min

 from 1 L/min to 2 L/min : step of 0.5 L/min

 from 2 L/min to 15 L/min : step of 1 L/min

Trigger E From 5 to 90 % of the inspiratory flow peak

Inspiratory flow (FLOW) 190 l/min

Flow-by Automatic

PS (pressure support) From 2 to 80 cmH2O (PSV - V SIMV+PS, P SIMV+PS)

SIGH in VC/VAC modality Interval : 40 ÷ 500 bpm (step 1 bpm)

Amplitude: OFF, 10 ÷ 100% of set Tidal Volume (step 10%)

CPAP From 3 to 50 cmH2O

APRV Time 1 and Time 2: from 1 to 200 sec.

Level 1 and Level 2: from 3 to 50 cmH2O.

Other controls  MENU function, SET function

 Function to select Loops, Curves, Parameters’ Map displaying
 INSP Block and EXP Block (max. 20 seconds)
 NEB control
 O2 100% (O2 al 100% max. 5 min) control

 MAN control (manual ventilation)

NEB Drug nebulizer: selectable to 6 l/min with automatic compensation on forced

ventilation modes and dedicated output

Patient circuit  Double hose, non re-breathing

Expandability Software upgradeable for future modalities

Falco 202_EVO_980209-GE_te_rev3.1.doc 4/8

USER INTERFACE

Monitor Module with TFT LED display

Dimensions 9”

Displaying area 168x126 mm

Display keyboard Keyboard for rapid access of functions. Encoder knob for:

 selection, set up and confirmation of physiological breathing parameters

 selection and direct activation of function

Displaying and settings  Setting of Operative Mode

 Visualization of alarm messages and signals
 Setting and monitoring of physiological breathing parameters
 Visualization of additional graphs and breathing parameters
 The function MENU for setting operation parameters
 Activation of special functions
 Visualization of operative mode, clock, date and time functions
 Visualization of software version

MENU function  SETUP adjustments

 Alarms
 Trends
 Events
 Patient data
 Default parameters

SETUP function (settings)  Language

 Graphic
 Volume
 Energy saving
 Brightness
 Apnoea time
 Gas sensor N2O : unit of measurement
 Password
 TCP setting
 Technical contact
 Test on demand
 Gas sensor
 Colour selection

Falco 202_EVO_980209-GE_te_rev3.1.doc 5/8

 Trends Storage capacity (72 h) of all measured parameters.

Events Memory storage up to 100 machine events including the alarms.

Patient data The patient data can be set and cancelled

Default parameters The default parameters can be restored

SETTING function (set of CPAP (cmH2O), FLOW (L/min), I:E, Level 1 – Level 2 (cmH2O), O2 (%),
physiological breathing
parameters) Pause (%), PEEP (cmH2O), PLIM (cmH2O), PMax - Pmin - PS (cmH2O),
RR(bpm), RRsimv (bpm), SIGH (% - bpm), Ti max (s), Ti (s), Trig. E (%),
Trig. I (L/min - cmH2O ), Time 1 - Time 2 (s), Vte - Vti (ml), BACK-UP
parameters
Range of measured  PAW: peak, mean, plateau, PEEP (range -20 ÷ 80 cmH2O)
parameters
 Tinsp., Texp, Tpause (range 0.036 ÷ 10.9 sec)

 I:E ratio (range 1:99 ÷ 99:1)

 Static and dynamic compliance (range: 10 ÷ 150 ml/cmH2O)

 Resistance (range: 0 ÷ 400 cmH2O/l/s)

 % of FiO2 (range: 0% ÷ 100%)

 Rate (range: 0 ÷ 150 bpm)

 Tidal Volume: Vte, Vti (range: 0 ÷ 3000 ml)

 Minute Volume (range: 0 ÷ 40 l/min)

 Inspiratory Peak Flow (range: 1 ÷ 190 l/min)

 Expiratory Peak Flow (range: 1 ÷ 150 l/min )

 EtCO2: with optional CO2 module (range: 0 ÷ 10%)

Displayed parameters FR (bpm), I:E, FiO2 (%), Vt (ml), VM (L/min), PAW (cmH2O), PEEP (cmH2O)

Additional displayed MAP (cmH2O), Pplateau (cmH2O), Fi (L/min), Fe (L/min), Ti (sec.), Te (sec.)
parameters
Tpause (sec.), Ri (cmH2O/L/sec.), Cs (ml/cmH2O)

Displayed graphics  CURVES: Pressure - Flow - Volume

 LOOPS : Pressure / Volume - Flow / Volume - Pressure/Flow
 Auto range

Flow sensor Magnetic disturbance (patented), multi-usage type

Calibration Automatic (started by the operator)

Maintenance By steam or chemical disinfection

Oxymeter Electronic (value displayed in breathing parameters)

Calibration Automatic (started by the operator)

Falco 202_EVO_980209-GE_te_rev3.1.doc 6/8

ALARMS

Alarm types By MENU: with limits set by the operator

By default: the operator cannot set them up

Alarm priority High - Mean - Standby

Alarms with limits set up by the operator

Airways pressure High – Low
Breathing rate High – Low
Expired minute volume High – Low
Expired tidal volume High – Low
PEEP High – Low
FiO2 concentration High – Low

EtCO2 High – Low (with optional CO2 Module)

Electric power supply Alarm occurs in case of failure of external power supply
Apnoea Low Rate (function of Apnoea BACK-UP)

System alarms

Level (charge) Battery at 50%

Level (charge) Battery at 25%

Battery level (low) 10 Minutes
Disconnected battery Yes / No
Gas feeding: O2 Low (< 2.7 bar)

CAN BUS error Electronic boards CAN connection wrong

Maintenance 2000 hours

Battery over temperature Indication of exceeding the temperature limits inside the battery

Turbine fault Signals in case of a blower fault condition

Turbine over temperature Indication of exceeding the temperature limits inside the turbine

SELF-TEST alarms

Turbine The correct functioning of the turbine is tested

It is performed a washing of the remaining oxygen present within the lung
O2 emptying
ventilator, order to measure the offset of the oxygen sensor
Electro-valve The correct functioning of electro-valve is tested
Gas supply Verification of the presence of O2 supply pressure

EXP.- INSP. Flow sensor Verification of EXP flow sensor operation

Falco 202_EVO_980209-GE_te_rev3.1.doc 7/8

 Airways pressure sensor Verification of pressure sensor operation through control of PAW reading
Patient circuit Verification of patient circuit
Battery Checking on battery power
Oxygen cell Cell condition
Acoustic alarm Verification by the user of acoustic signal emission, the confirmation of the
test is made by silencing of that alarm

ACCESSORIES
Supplied Accessories  User's Manual
 Dual limb circuit
 Antibacterial filter for patient circuit
 Nebulizer set
 Power cable
 Vehicular cable for 12 Vdc
 O2 supply hose

SIARE applies the UNI EN ISO 13485:2004 Quality System and the 93/42 EEC.

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.

Via Pastore , 18 - Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel : +39 051 969802 - Fax : +39 051 969366
Email : mail@siare.it - http://www.siare.it

Falco 202_EVO_980209-GE_te_rev3.1.doc 8/8