Siare Falco 202 Evo User Manual
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Siare Falco 202 Evo User Manual

Lung ventilator
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Falco 202 Evo - 10.4"
Lung Ventilator
Turbine-driven ventilation
Touch Screen
User's Manual

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  • Page 1 Falco 202 Evo - 10.4” Lung Ventilator Turbine-driven ventilation Touch Screen User’s Manual...

  • Page 3: General Information

    The contents of this manual do not in any way limit the right of SIARE Engineering International Group s.r.l. to revise, change or modify without prior notice the equipment (including the relative software) described herein.

  • Page 4: Observations

    We would be grateful if you would send us your comments (see address at page IX). The SIARE trademark is used throughout this manual as an abbreviation for the manufacturer: SIARE Engineering International Group s.r.l.

  • Page 5: Warnings, Cautions And Notes

    You are advised to carefully read the information given alongside the three symbols shown on the previous page, since it contains considerations on the safety, the special requirements for the use Falco 202 Evo (10.4”) lung ventilator (hereinafter called lung ventilator) and the relative safety regulations.
  • Page 6  SIARE is aware that cleaning, sterilisation and disinfection procedures vary considerably from one health structure to another. SIARE cannot be held responsible for the efficacy of the cleaning and sterilisation procedures, nor for the other procedures carried out while the patient is being treated. As...
  • Page 7  SIARE assumes all foreseen legal liability if the lung ventilator is used and periodically maintained according to the instructions contained in this manual: the Technical Assistance Report, drawn up and signed by the authorised SIARE technician, is proof of the completion of the scheduled maintenance.
  • Page 8 Before starting the lung ventilator use, you have to carry out the preliminary checks.  Before connecting the lung ventilator to other electrical equipment not described in this manual, a request for authorisation should be sent to Siare.  Qualified staff must make the regulation of ventilation parameters. WARNING !! Do not block the gas intake port or emergency intake port, thereby interfering with PATIENT ventilation.

  • Page 9: Year Of Manufacture

    The Directive 93/42EEC on medical devices foresees that the manufacturer defines the shelf life of the device according to the intended purpose. The shelf life foreseen by SIARE for the lung ventilator model Falco 202 Evo is 10 years. Manufacturer SIARE Engineering International Group s.r.l.

  • Page 10: Electromagnetic Compatibility

    The Falco 202 Evo (10.4”) lung ventilator is designed to operate in the specified electromagnetic environment (see warning below). The customer or the user of Falco 202 Evo lung ventilator should ensure that it is used in such an electromagnetic environment.

  • Page 11: Table Of Contents

    Main innovations ....................1-2 1.2.1 Automatic compensation of all ventilation parameters .......... 1-2 1.2.2 Falco 202 Evo: high performance intensive care ventilator ........1-2 1.2.3 PEEP and leakages compensation ............... 1-2 1.2.4 10.4” LED display touch screen and graphic interface .......... 1-2 1.2.5...
  • Page 12 10.4’’ LED display touch screen ................. 2-13 2.3.1 Selectable Operative Modes ................2-14 2.3.2 Operative command : Start / Stop ............... 2-16 2.3.3 Patient Data ......................2-17 2.3.4 Alarm visualization area ..................2-18 2.3.5 Physiological Respiratory Parameters ( PRP ) ............ 2-20 2.3.6 PRP list ........................
  • Page 13 4.10.2 Modification Charts combination ................4-57 4.10.3 Loops combination modification ................4-59 4.10.4 TRENDS visualization..................4-62 4.10.5 EVENTS visualization ..................4-63 4.11 Default parameters ..................... 4-64 4.12 Alarms SETUP ....................4-65 4.13 Patient Data SETUP ................... 4-65 XIII Falco 202 Evo...
  • Page 14 4.14 List of functions ....................4-65 4.15 List of default parameters ................... 4-68 4.16 Calibration Programs ..................4-69 4.16.1 Preliminary ......................4-69 4.16.2 Calibration Programs displaying ................4-70 4.16.3 Turbine characterization ..................4-71 4.16.4 Expiratory Flow Sensors Calibration ..............4-72 4.16.5 High Altitude usage ( On - Off ) ................
  • Page 15 Pneumatic diagram legend .................. A-19 Glossary ......................A-20 EMC tables - Guidance and manufacturer’s declaration ........A-25 A.6.1 Table 1 ......................... A-25 A.6.2 Table 2 ......................... A-26 A.6.3 Table 3 ......................... A-27 A.6.4 Table 4 ......................... A-28 ANNEX ........................B-1 Falco 202 Evo...
  • Page 16 This page has been added to make front / back copy easier. User manual, DU3104101...

  • Page 17: Introduction

    “foolproof”, in this way there is no margin for the user to make incorrect or inadequate manoeuvres. The new Falco 202 Evo (10.4”) lung ventilator is very different from all the previous versions and it has been conceived for the using in Intensive Care, Emergency and Transport. Even the maintenance procedures have been simplified and the parts subject to wear or deterioration have substantially decreased.

  • Page 18: Main Innovations

    Main innovations The new 2nd generation of Falco 202 Evo (10.4”) combines aesthetic and reliability in an ergonomic structure which permit to the device to be easy to use and easy to understand. 1.2.1 Automatic compensation of all ventilation parameters ...

  • Page 19: Small And Powerful

    Dimensions, 290 x 245 x 215 mm (W x H x D) and light weight 5.5 Kg.  These special features permit to the Falco 202 Evo to be handy and easy to use in small spaces even during transport.

  • Page 20: Electronics And Driving

    (see on chapter 2). The Falco 202 Evo incorporates a series of sensors for continuous patient monitoring, the most important of which are: ...

  • Page 21: Use

    1.4.1 Use The use of Falco 202 Evo (10.4”) lung ventilator is simple and intuitive for the persons skilled on resuscitation ventilators, a short training course is in enough to learn how to use it. A basic user interface: keyboard, encoder knob and a 10.4” touch screen display simplifying the selection of the most suitable settings.

  • Page 22: Norms And Standards Regulations

    Norms and standards regulations The Falco 202 Evo (10.4”) lung ventilator is made in compliance with the following norms (and following updates) and it is manufactured according to UNI EN ISO 13485:2016 standards. EN 60601-1 :2006/A1 :2011/A1 :2013 Medical electrical equipment. General requirements for basic safety and essential performance.

  • Page 23: Description

    DESCRIPTION This section of the user manual features the main parts and components of Falco 202 Evo (10.4”) lung ventilator (hereinafter called lung ventilator) and some of its most used functionalities. Overall view With regard to the assembly, the interface and the servicing operations, please refer to the relative chapter or contact Siare technical support service.

  • Page 24: Power Supply Area

    Rear view : Falco 202 Evo ( 10.4” ) see 2.1 Overall view (front, side and rear view) see 2.1.1 Power supply area see 2.1.2 Pneumatic area (Oxygen) see 2.1.3 Patient connections see 2.2 Touch screen / Keyboard and encoder knob see 2.3...
  • Page 25 Side view: Falco 202 Evo ( 10.4” ) AIR FILTER: turbine air filter connection (see following chapter) Air intake RS232 RS-232 (ODU connector) for CO sensor connection USB connectors: CPU programming or Trend and Events downloading Power supply (please, refer to following paragraph)
  • Page 26 An external battery used as power source for the functioning of the Falco 202 Evo become integral part of this medical system. I / O: lung ventilator supply switch FUSE 2 x 1AT: safety fuses for 220 Vac power supply circuits...

  • Page 27: O 2 Pneumatic Area

    LOW PRESSURE: the medical O low pressure source should have a maximum flow of 15 l/min. HIGH PRESSURE: the medical O pressure should range from 280 kPa to 600 kPa (2.8 - 6 bar / 40 - 86 psi). Falco 202 Evo...

  • Page 28: Patient Connections

    2.1.3 Patient connections FLOW SENSOR: flow sensor placed on expiratory patient line SENSOR: mechanical guard for O sensor electrical connection V.EXP (option): unused fitting NEBULIZER: outlet fitting for nebulizer circuit ( 6 l/min ) INSP. TO PATIENT: inhalation fitting for patient circuit Transport handle User manual, DU3104101...

  • Page 29: Touch Screen And Keyboard

    Select icon to STOP ventilation; lung ventilator goes to Stand-by mode. Operative mode  Select the area indicating Operative Mode  All available operative modes are shown  Select the new operative mode  Confirm the selection Falco 202 Evo...
  • Page 30 Respiratory parameters set  Select the area indicating the respiratory parameters to be modified.  The modification bar is displayed.  Select the new parameter’s value on the bar:  Drag the cursor  Select the icon + or - ...
  • Page 31  Select the area to display other respiratory parameters.  Other respiratory parameters related to VC/VAC operative mode are displayed.  To return to previous displaying, re-select. This displaying modality can be applied to patient’s monitoring parameters. Falco 202 Evo...
  • Page 32 Graphic visualization  The User can display different types of detections: Loops / Charts / Measures.  Select the area indicating for example the graphic to be modified for a few seconds.  The selected area (purple marked box) becomes green. ...

  • Page 33: Keyboard - Soft Key And Encoder Knob

    Whenever the condition that activated the alarm is no more present, by a second pressure of the key, it is possible to cancel the visual indication on the screen. By pressing ESC soft key, it is possible to escape from “current” screen to return to “previous” one. 2-11 Falco 202 Evo...
  • Page 34 The multifunction encoder knob is used to select, modify and confirm all the functions shown on display. The encoder knob is used to access the MENU function and then to function modes, parameters, alarms, parameters’ values and all is concerned to the normal operation of lung ventilator. Use of encoder knob.

  • Page 35: Led Display Touch Screen

    10.4’’ LED display touch screen On the front side of Falco 202 Evo lung ventilator (hereinafter called lung ventilator) there is a 10.4” LED display (touch-screen) that visualizes all the information useful for patient ventilation. Operative mode selection, respiratory parameters setup and monitoring, visual and acoustic alarm warnings, loops and curves, are the main featured information visualized.

  • Page 36: Selectable Operative Modes

    2.3.1 Operative Modes Selectable  The Falco 202 Evo includes the most modern ventilation modes: volume controlled ventilation, pressure controlled ventilation, pressure supported, non invasive ventilation and manual ventilation.  The User can select one of these ventilation modes using the touch screen or/and the keyboard (please see cap.
  • Page 37 Airway pressure release ventilation: this type of ventilation features two positive pressure levels. After selecting the most suitable operative mode for patient ventilation, the system will automatically display the physiological respiratory parameters ( PRP ) for the new setup. 2-15 Falco 202 Evo...

  • Page 38: Operative Command: Start / Stop

    2.3.2 Operative command: Start / Stop Two controls next to the operative mode’s selection is available and useful for the lung ventilator operations. The two controls are comparable with the ones located on the keyboard. Select the icon to Start ventilation in the selected operative mode.

  • Page 39: Patient Data

    PATIENT DATA displaying allows setting / modification of these data.  Patient type  Male / Female  Name / Surname  Physical date  Birthday  Note For further information about PATIENT DATA set, please see cap. 4.5. 2-17 Falco 202 Evo...

  • Page 40: Alarm Visualization Area

    2.3.4 Alarm visualization area  The lung ventilator features automatic means for detecting and identifying any conditions that might put the patient at risk (based on the level of urgency and seriousness), using acoustic or visual alarm signals.  The role of the alarm signal is to draw the attention of the User to the event as well as to inform him on the requested response speed.
  • Page 41 WARNING!! Patient injury hazard The User should not interrupt patient control during alarms silencing period. For more information, please see on chapter 5 Alarms. 2-19 Falco 202 Evo...

  • Page 42: Physiological Respiratory Parameters ( Prp )

    2.3.5 Physiological Respiratory Parameters ( PRP )  Select VC/VAC operative mode.  Selecting the PRP parameters icon.  The parameters related to the set Operative Mode are displayed. 2-20 User manual, DU3104101...

  • Page 43: Prp List

    RR BK (bpm): Back-up respiratory rate, used when an Apnoea condition arises to enable a controlled ventilation mode. CPAP/PEEP (cmH Continuous positive airway pressure during respiration phase in CPAP operative mode. Ratio between inspiration and expiration phases. 2-21 Falco 202 Evo...
  • Page 44 Concentration percentage delivered to the patient can be set from 21% to 100%. Pressure Low (cmH O) - Pressure High (cmH Pressure levels to be set in APRV mode. Pause (%) Inspiratory pause time. The “inspiratory pause time” is displayed on the screen in % (% of the inspiratory time).
  • Page 45 Tr. I (L/min) (cmH2O) Flow level (pressure) for detecting the patient spontaneous breathing. Vte (ml) Expired tidal volume guaranteed for the patient. Vti (ml) Inspired tidal volume guaranteed for each breath. 2-23 Falco 202 Evo...

  • Page 46: Monitoring Of Respiratory Parameters

    2.3.7 Monitoring of respiratory parameters  Based on the lung ventilator parameters set by the User and on the patient's characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation. ...
  • Page 47 The value is detected by the gas sensor analyzer installed on the expiratory line. Description Vte : respiratory parameter ml : unit of measurement 503 : value set by the User 1000 - 100 : alarm limits 2-25 Falco 202 Evo...

  • Page 48: Monitoring Of Additional Breathing Parameters

    2.3.8 Monitoring of Additional breathing parameters  Based on the lung ventilator parameters set by the User and on the patient's characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation.
  • Page 49 (it maintains a pause pressure) for a certain amount of time of the inspiratory time, defined by the User (INSP PAUSE %). The static conditions allow the lung ventilator to calculate the breathing mechanics parameters. 2-27 Falco 202 Evo...
  • Page 50 Inspiratory resistance It is the parameter of the lung mechanics that describes the resistance to the opposite flow of the airways: measured in O/(l/s). The greater the patient resistance, the higher the airway pressure you need to apply to obtain the same volume. The formula used by the ventilator to calculate the inspiratory resistance is as follows: Ri = (peak pressure –...

  • Page 51: Measures, Charts And Loops

    Charts : PAW , Flow , Tidal Volume, O , CO  Loops : Tidal Volume / Flow , PAW / Tidal Volume , PAW / Flow  Measures : respiratory parameters  Lung status icon  Trends  Event 2-29 Falco 202 Evo...
  • Page 52  To change the combination of curves displayed, the lung ventilator must be started.  Select “GRAPHICs” icon to quit the function. For more information, please see on cap. 4.10. 2-30 User manual, DU3104101...

  • Page 53: Loops Area: Lung Status

    If the airways pressure does not reach the value of “Low Pressure” alarm parameter, the lungs icon turns red and after about 15 seconds, the system activates the Low Pressure alarm. For more information, please see on cap. 4.10. 2-31 Falco 202 Evo...

  • Page 54: Operative Functions And General Informations

    2.3.11 Operative functions and general informations In the lower side of GUI there are a series of controls and functions that are useful for the Falco 202 Evo utilization. Leds: if Led is lit. indicate that the relevant function is enabled (or if it has been enabled);...
  • Page 55 Battery level (if the symbol is steadily lit and green, the battery is full).  Presence of mains power supply, (the “green plug” symbol means that the device is powered from mains). About “ General information ”, please see on cap. 5.2.4. 2-33 Falco 202 Evo...

  • Page 56: Menu, Alarms And Graphic's Set

    2.3.12 Menu, Alarms and Graphics’ set In the lower side of GUI there are a series of functions that are fundamental for the Falco 202 Evo utilization.  Select the icon to access the SETTING MENU.  Select the icon to “ Turn OFF “ the lung ventilator.
  • Page 57 (PRP) of the lung ventilator (breathing parameters and alarms levels).  Select the icon to access the lung ventilator's ALARM LIMITS page. Select the icon to access the lung ventilator’s GRAPHIC’s set page. 2-35 Falco 202 Evo...

  • Page 58: Product Identification Label

    Product identification label The product identification label mentions the following information.  Manufacturer  Model name  Main power supply  Battery’s features  Fuses features  Regulation (CE mark)  Serial number  Symbols (see description) The mark identifies the protection level against electric shock (category of protection type B).

  • Page 59: Preparation For Use

    PREPARATION FOR USE In the first section of this chapter explains the main installation phases of Falco 202 Evo (10.4”) lung ventilator. In the second section highlights the preliminary checks to be carried out before using Falco 202 Evo (hereinafter called lung ventilator).

  • Page 60: Before Use

    Before use 3.1.1 Mounting the O sensor WARNING !! User injury hazard To avoid electric shock risk and/or components parts breakage during interventions, please make sure that the lung ventilator's power supply is cut off.  Thoroughly unpack the O cell.

  • Page 61: Battery Recharge

    The mains voltage should match the one indicated on the identification plate placed on the back of the lung ventilator.  Make sure that on the keyboard the green led (that indicates the presence of mains power supply) is on. Falco 202 Evo...

  • Page 62: Preparation For Use

    100-240Vac / 50-60Hz. WARNING !! Patient / clinician injury hazard SIARE specialized personnel or qualified technical personnel formerly authorized by SIARE, shall always verify the following during the installation:  the presence of the ground cable in the electric plug used to connect the lung ventilator.
  • Page 63 A proper connector for low voltage power supply line (12Vdc / 7A) is placed on the lung ventilator rear side.  Insert the 12Vdc power supply cable plug to the plug placed on the back of the lung ventilator. Falco 202 Evo...
  • Page 64 Battery power supply WARNING !! Risk of failure  There should always be a battery installed inside the lung ventilator.  If there is no battery, the lung ventilator is not protected against voltage drops or mains power supply cut off. ...

  • Page 65: Protection Fuses

    Fuse replacing WARNING !! Patient / clinician injury hazard The operations described below must be carried out only by highly qualified staff, specifically trained and authorised by SIARE. If a protection fuse breaks, please proceed as follows.  Cut OFF mains power supply.

  • Page 66: Medical Gas Connection

    3.2.3 Medical gas connection The fast connections mounting, suitable for the medical gas distribution system, as well as all pneumatic supply hoses maintenance and/or replacement operations should be carried out only by qualified staff, so as to prevent any gas inversions that might be fatal for the patient. ...

  • Page 67: Bi-Tube Patient Circuit Connection

    > 210 mL Adults 3.2.5 Nebulizer  Connect the supplied nebulizer circuit to the suitable coupling [NEBULIZER] on the lung ventilator. Use the command (NEB function) available on the graphical user interface (GUI) to activate the Nebulizer function. Falco 202 Evo...

  • Page 68: Use Of Antibacterial Filters

    3.2.6 Use of antibacterial filters Apply the antibacterial filters to the patient circuit. For more information, please see documentation attached to the product.  Moisture loss 6.7 mg H  31.6mg H Calculated moisture return  Resistance at 30L/min 0.2 cm H ...

  • Page 69: Connection Of Gas Analyzer (Gas Sensor)

    Connect the GAS ANALYZER to the interface device.  Mainstream GAS ANALYZER  Connect the sensor to the patient circuit.  Sidestream GAS ANALYZER  Connect the sampling line to the GAS ANALYZER.  Connect the sampling line to the patient circuit. 3-11 Falco 202 Evo...

  • Page 70: Data Connection (Trend And Events Downloading)

     Verify the functioning of the Mainstream GAS ANALYZER  Switch ON the electric power supply.  A green LED (on the gas analyzer) indicates that the IRMA analyzer is ready for use.  Verify the functioning of the Sidestream GAS ANALYZER ...

  • Page 71: Connection Of Other Devices

    Connection of Siare devices In order to connect to the lung ventilator other devices manufactured by Siare, please refer to the connection instructions attached to this manual. WARNING !! Patient / clinician injury hazard Do not connect to the lung ventilator any external devices NOT manufactured or NOT authorised by SIARE (example: discharge systems, patient simulators, etc…..), and that are not described in this user manual.

  • Page 72: Use

    (patient circuit, oxygen probe, flow sensor, etc…) Before starting preliminary tests, the Falco 202 Evo lung ventilator must be:  prepared for use (cfr. Maintenance, Cleaning, Disinfection and Sterilisation) ...
  • Page 73 Do not use the lung ventilator if you detect any suspect oxygen leaks from the lung ventilator or any other unit next to it. Close all oxygen supply sources and contact the nearest Siare Support Centre or any other support centres authorised by Siare.

  • Page 74: Ventilator Switch On / Self Test Phase

    3.3.2 Ventilator switch ON / Self Test phase  Set the main switch (placed on the back of the ventilator) to “I”.  Make sure that on the lung ventilator keyboard (commands area) the green led (that indicates the presence of mains power supply) is on. ...
  • Page 75 CAUTION. Acoustic Alarm: Fail. If you do not hear any acoustic alarm signal and/or you did not press the Alarm Reset key, the red message “ Press OK to begin anyway ” will appear on the screen. 3-17 Falco 202 Evo...
  • Page 76 START to begin anyway “. WARNING !! Patient/User injury hazard The Self Test phase did not complete successfully. Please see chap. 5.3 or contact the nearest Siare Support Centre or any other support centres authorised by Siare. 3-18 User manual, DU3104101...
  • Page 77 Patient type  Male / Female  Name / Surname  Physical date  Birthday  Note  PATIENT DATA set (see on chapter 4.3.1).  Select Cancel or OK for going ahead and display Stand-by page. 3-19 Falco 202 Evo...

  • Page 78: Turn The Lung Ventilator Off

    Stand-by mode  In Stand-by mode the User can set and/or edit all lung ventilator parameters and alarms limit relative to the operating mode that you will use on the patient that you want to treat. 3.3.3 Turn the lung ventilator OFF ...

  • Page 79: Preliminary Checks - Introduction

     Connect the power supply, the medical gases and the patient circuit.  Insert and connect the oxygen sensor.  Connect a patient simulator to the patient circuit terminal.  Lung ventilator ON: Stand-by mode. 3-21 Falco 202 Evo...

  • Page 80: Supplementary Tests

    3.4.1 Supplementary Tests To carry out the Supplementary Tests you must know the keyboard operating mode and the options available in the lung ventilator SETTING MENU (please see chapter 4).  Select the icon to access the lung ventilator’s SETTING MENU.
  • Page 81 Flow Sensors Calibration.  The system will visualize the Expiratory Flow Sensors Calibration page. CAUTION Not being a useful procedure for the purpose of "Preliminary Checks", see chapter 4.16 for a more detailed description of the same. 3-23 Falco 202 Evo...

  • Page 82: O2 Sensor Calibration

    3.4.3 O sensor calibration WARNING !! Risk of M.D. failure and/or injuries for the patient  This procedure should be carried out to check the proper operation of the oxygen sensor.  Perform this procedure monthly.  Select O Sensor calibration.
  • Page 83 6 “Maintenance“. CALIBRATION procedure Failed If the system does not exceed the preliminary checks phase, please see chapter 5 Alarms - Trouble Shooting or contact the nearest Siare Support Centre or any other support centres authorised by Siare. 3-25...

  • Page 84: Exit From Supplementary Tests

    Sensor calibration not overcome The oxygen sensor calibration procedure was not completed successfully.  Sensor Calibration Failed.  Sensor Calibration Aborted. WARNING !! The TEST result is negative  Check if the oxygen sensor is installed and electrically connected.  Check if the O sensor is worn out (the oxygen detection cell is worn out;...

  • Page 85: Preliminary Checks - Lung Ventilator

    Select the parameter you want to change.  For more information about PRP set, please see on chap. 2.3.5. For tests and checks, please use the patient simulator SIARE cod. LS.AB.001 that is equipped with variable resistance and compliance. 3-27...
  • Page 86 3. Set the physiological respiratory parameters (PRP) Pause PEEP OFF, 5, 10 cmH2O Tr. I -2 cmH2O 1 L/min 4. Select / Press START: the lung ventilator begins its cycle. 3-28 User manual, DU3104101...

  • Page 87: Preliminary Checks - Monitoring Parameters

     PEEP: 5, 10 cmH2O  Tr. I: -2 cmH2O, 3 L/min  O2: 60% 7. Check the correspondence between the monitored parameters and the displayed curves. 8. Select the key to display all the parameters. 3-29 Falco 202 Evo...
  • Page 88 CAUTION. Lung Ventilator operation check  Make sure that the airways pressure increases during the inspiratory phase.  Make sure that the airways limit pressure intervenes (pressometric operating mode).  Make sure that the variation in the set oxygen concentration value (O corresponds.

  • Page 89: Preliminary Checks - Alarms

     NO: it remains in Alarm page. Select  YES: to quit Alarm page; the alarm set will be saved.  NO: it remains in Alarm page To set or modify the Alarm Limits make reference to chapter 5 (Alarms). 3-31 Falco 202 Evo...

  • Page 90: Alarm Limits Check

    3.5.3 Alarm limits check WARNING !! Severe patient injuries The alarms must trigger at the proper time and in the correct manner.  Check the proper activation of the visual and acoustic signals. Before starting the alarm limits, check the alarms setup, and change the set values whenever necessary (please see previous paragraph).
  • Page 91 Set the low expired Vm alarm limit to 5 l.  During ventilation, set Vti to 175 ml / 20 bpm.  The system activates the low expired Vm alarm: silence the alarm.  Restore the default alarm value. 3-33 Falco 202 Evo...
  • Page 92  Set a O concentration to 50% on the lung ventilator.  Set the high O concentration alarm limit to 30%. High oxygen concentration  The system activates the high O alarm: silence the alarm.  Restore the default alarm value. ...

  • Page 93: Conclusions

    3.5.4 Conclusions Carry out all preliminary checks and make sure that they were completed successfully before connecting the patient to the Falco 202 Evo lung ventilator. CAUTION - Preliminary checks phase failed. Please see Alarms chapter and/or Trouble Shooting chapter.

  • Page 94: Preliminary Checks Sequence List

    Preliminary checks sequence list Preliminary checks - Introduction 3-21 3.4.1 Supplementary Tests 3-22 3.4.2 sensor calibration 3-23 3.4.3 Exit from Supplementary Tests 3-26 Preliminary checks - Lung Ventilator 3-27 3.5.1 Preliminary checks - MONITORING PARAMETERS 3-29 3.5.2 Preliminary checks - ALARMS 3-31 3.5.3 Alarm limits check...

  • Page 95: Lung Ventilator Use

    LUNG VENTILATOR USE This chapter shows you how to use the Falco 202 Evo (10.4”) lung ventilator for intensive care, (hereinafter called lung ventilator). Thoroughly read this chapter and the whole manual to make sure respiratory parameters and alarm limits are set correctly and choose the most suitable ventilation mode. The User must choose the Operative modes and the alarm limits best matching patient's physiological state and pathologies.

  • Page 96: Ventilator Switch On / Self Test Phase

    Ventilator switch ON / Self Test phase  Set the main switch (placed on the back of the ventilator) to “I”.  Make sure that on the lung ventilator keyboard (commands area) the green led (that indicates the presence of mains power supply) is on. ...
  • Page 97 Stand-by page. Stand-by mode  In Stand-by mode the User can set and/or edit all lung ventilator parameters and alarms limit relative to the operating mode that you will use on the patient that you want to treat. Falco 202 Evo...

  • Page 98: Patient Data / Setup Parameters

    PATIENT DATA / SETUP parameters Actually, the lung ventilator software does not switch directly from Self Test phase to Stand-by operative mode, but it previously displays a page which allows the adjustment of the following types of information and machine setup.
  • Page 99 Select the desired data area: the system displays a keyboard for entering the Patient Data. Once completed the entering of patient data, save or cancel what is typed in the page.  Select OK :  Select Cancel : Falco 202 Evo...
  • Page 100 Once completed the entering of patient data, save or cancel what is indicated in the page.  Select PATIENT DATA setting will NOT be saved.  Select PATIENT DATA setting will be saved.  The system will display the Stand-by screen. User manual, DU3104101...

  • Page 101: Setup Parameters

    User can modify the parameters SETUP selecting the function: SETUP MENU. The SETUP displaying allows to determine the operation settings of lung ventilator.  Select SETUP MENU Display  BRIGHTNESS  ENERGY SAVING  SOUND VOLUME  TOUCH AUDIO Falco 202 Evo...
  • Page 102 Date & Time  Date  Time Language  Italian  English  German  Turkey  Polish  French  Russian  Spanish Units  Weight (referred to the patient)  Height (referred to the patient)  CO2 (unit of measurement) ...
  • Page 103  APNOEA TIME  CHANGE PASSWORD  Save to USB At the end, save or cancel what is set in SETUP pages.  Select YES: to quit SETUP page without saving. NO: it remains in SETUP page. Falco 202 Evo...
  • Page 104  Select YES: the set values will be saved. NO: it remains in SETUP page.  The system will display the Stand-by screen. It is suggested to set the parameters: see the following chapters. 4-10 User manual, DU3104101...

  • Page 105: Setting Up The Ugi Language

    Mode 1: at ventilator start-up at the end of Self Test phase. Mode 2: during normal operation of lung ventilator. 4.3.1 Mode 1 At the end of Self Test phase, the system displays the page: PATIENT DATA.  Select: SETUP  Select: Language 4-11 Falco 202 Evo...
  • Page 106 A series of MENU languages are available and identified by an icon.  Select the flag.  Confirm the choice.  Press YES: the setting will be saved.  Press NO: it remains to language setting. The UGI (User Graphic Interface) language is ENGLISH. 4-12 User manual, DU3104101...

  • Page 107: Mode 2

    4.3.2 Mode 2 Lung ventilator in Stand-by operative mode.  Select: SETTING MENU  Select: Language At Language page the SETUP / PATIENT DATA screen is displayed. 4-13 Falco 202 Evo...
  • Page 108 A series of MENU languages are available and identified by an icon.  Select the flag  Confirm the choice  Press YES: the setting will be saved.  Press NO: it remains to Language setting. The UGI (User Graphic Interface) language is ENGLISH. 4-14 User manual, DU3104101...
  • Page 109 Mode 1: at ventilator start-up at the end of Self Test phase (see on 4.2.1). Mode 2: during normal operation of lung ventilator (see on 4.6.1). 4.4.1 Mode 2 Lung ventilator in Stand-by operative mode.  Select: SETTING MENU  Select: Display 4-15 Falco 202 Evo...
  • Page 110  Select: PATIENT DATA The displaying of PATIENT DATA allows to set / modify the following data.  Patient type  Male / Female  Name / Surname  Physical date  Birthday  Note To set/modify the PATIENT DATA; see on 4.3.1. 4-16 User manual, DU3104101...

  • Page 111: Erasing The Patient Data

    4.4.2 Erasing the PATIENT DATA Lung ventilator in Stand-by operative mode.  Select: SETTING MENU  Select: Default  Select: Patient data Default Confirm the choice: select Cancel the choice: select 4-17 Falco 202 Evo...
  • Page 112  Press YES: to RUN the selected DEFAULT.  Press NO: to cancel the command.  Select: SETTING MENU  Select: Display  Select: PATIENT DATA The page of PATIENT DATA is displayed in Default configuration. To enter the PATIENT DATA; see chap. 4.2.1. 4-18 User manual, DU3104101...

  • Page 113: Setting Up The Alarms

    NOT be saved. NO: it remains in Alarm page.  Select YES: to quit Alarm page; the alarm set will be saved. NO: it remains in Alarm page. For ALARMS parameters and limits setup, please see on 5.2. 4-19 Falco 202 Evo...

  • Page 114: Operative Modes

    Operative modes In the following chapter you will find a description of available Operative Modes selectable on Falco 202 Evo lung ventilator. WARNING !! Patient injury hazard The User must choose the Operative modes that match the patient's physiological features and pathologies best.
  • Page 115  PRP parameters referred to the APCV-TV operative mode can be displayed.  Select the icon for see all PRP parameters. Lung ventilator in Stand-by, ready to be used in APCV-TV operative mode. 4-21 Falco 202 Evo...
  • Page 116 2. Lung ventilator in normal operation  Operative mode: VC/VAC.  All the operative modes foreseen can be displayed.  Select a new operative mode.  APCV-TV operative mode selected.  A second column with the PRP parameters referred to the APCV-TV operative mode can be displayed.
  • Page 117 VC/VAC operative mode.  NO: to exit.  NO: The system remains in the condition where the PRM of the two operative modes selected are displayed.  YES: The system goes back to the VC/VAC. 4-23 Falco 202 Evo...

  • Page 118: Apcv (Niv Apcv)

    Operative modes list 4.6.2 APCV (NIV APCV) Assisted pressure controlled ventilation, synchronised with patient's breathing with leak compensation.  The system displays all PRP relative to the set operative mode. APCV is a pressure controlled ventilation, synchronised with the patient's breathing with leak compensation.
  • Page 119 The greater the value, the greater the patient's effort to breath. If the pressure set is not reached, make sure that the patient circuit is perfectly sealed and that the PRP parameters are properly set. 4-25 Falco 202 Evo...

  • Page 120: Apcv-Tv

    4.6.3 APCV-TV (Volume Targeted) Pressure controlled ventilation, synchronised with patient's breathing and with guaranteed current volume.  The system displays all PRP relative to the set operative mode. APCV-TV is a pressure controlled ventilation, synchronised with the patient's breathing (automatic Pinsp) with guaranteed current volume (Vte). The system generates a ventilation at automatic inspiration pressure (automatic Pinsp), in order for the expired volume to equal the volume set (Vte).
  • Page 121 4-27 Falco 202 Evo...

  • Page 122: Psv (Niv Psv)

    4.6.4 PSV (NIV PSV) Assisted pressure support ventilation with guaranteed safety respiratory rate, set by the User (Apnoea Back Up) with leak compensation.  The system displays all PRP relative to the set operative mode. PSV is an assisted type of ventilation with pre-set pressure support (PS) with guaranteed safety respiratory rate set by the User in case of patient apnoea (RR bk) and with leak compensation.
  • Page 123 If the patient does not trigger (spontaneous breathing during the apnoea time set in SETUP - Other), the system enables the APNOEA acoustic and visual alarm. The system will automatically provide an APCV ventilation with set safety respiratory rate (RR bk) and I:E ratio (I:E bk). 4-29 Falco 202 Evo...

  • Page 124: Psv-Tv

    4.6.5 PSV-TV (Volume Targeted) Pressure support ventilation with guaranteed current volume and guaranteed safety respiratory rate set by the User (Apnoea Back Up).  The system displays all PRP relative to the set operative mode. PSV-TV is an assisted pressure support ventilation with guaranteed current volume and guaranteed safety respiratory rate set by the User in case of patient apnoea (RR bk).
  • Page 125 If the patient does not trigger (spontaneous breathing during the apnoea time set in SETUP - Other), the system enables the APNOEA acoustic and visual alarm. The system will automatically provide an APCV-TV ventilation with set safety respiratory rate (RR bk) and I:E ratio (I:E bk). 4-31 Falco 202 Evo...

  • Page 126: Vc-Vac

    4.6.6 VC-VAC Volume targeted controlled ventilation synchronised with the patient if the inspiratory trigger is active.  The system displays all PRP relative to the set operative mode. VC/VAC is a volume-targeted controlled ventilation (Vti), synchronised with the patient's breaths if the inspiratory trigger (Tr. I) is active. The Operative Mode VC/VAC is active only with patients: ADULT and PAEDIATRIC.
  • Page 127 If the patient's spontaneous breathing respiratory rate is greater (than the respiratory rate set on the lung ventilator) the machine will increase the number of breaths per minute (with regard to the number set in the control panel) and displays the value. 4-33 Falco 202 Evo...

  • Page 128: Vc-Vac Baby

    4.6.7 VC-VAC BABY Volume targeted controlled ventilation synchronised with the patient if the inspiratory trigger for paediatric and neonatal patients is active.  The system displays all PRP relative to the set operative mode. VC/VAC BABY is a volume-targeted controlled ventilation (Vte), synchronised with the patient's breaths if the inspiratory trigger (Tr.
  • Page 129 If during the expiratory phase, the patient generates a spontaneous breath that enables the trigger, the lung ventilator will synchronise its activity to the patient's spontaneous breath, recalculating the I:E cycle times starting from that event and displaying them on the lung ventilator screen. 4-35 Falco 202 Evo...

  • Page 130: V-Simv

    4.6.8 V-SIMV Volume-targeted synchronised intermittent mandatory ventilation.  The system displays all PRP relative to the set operative mode. V-SIMV is a synchronised intermittent mandatory ventilation, during which the lung ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set volume (Vti).
  • Page 131 The graphic shows how the SIMV operative mode works. The spontaneous activity between one synchronised breath and the other is 70% managed in pressometric mode (PS) while the remaining 30% represents the window for the activation of the forced synchronised breathing. 4-37 Falco 202 Evo...

  • Page 132: P-Simv

    4.6.9 P-SIMV Pressure-targeted synchronised intermittent mandatory ventilation.  The system displays all PRP relative to the set operative mode. P-SIMV is a synchronised intermittent mandatory ventilation, during which the lung ventilator generates a certain number of breaths per minute (RRsimv) at a pre-set inspiratory pressure (Pinsp) providing pressure support (PS) during the spontaneous phase.
  • Page 133 The graphic shows how the SIMV operative mode works. The spontaneous activity between one synchronised breath and the other is 70% managed in pressometric mode (PS) while the remaining 30% represents the window for the activation of the forced synchronised breathing. 4-39 Falco 202 Evo...

  • Page 134: Cpap

    4.6.10 CPAP Positive continuous pressure applied on the airway.  The system displays all PRP relative to the set operative mode. CPAP is a spontaneous positive pressure ventilation at continuous flow. In this operative mode the patient is free to breath spontaneously inside the circuit but at a pressure greater than the atmospheric one, with increased residual functional capacity.

  • Page 135: Aprv (Airway Pressure Release Ventilation)

    If during spontaneous breathing the patient does not reach the airway low pressure limit (LOW PAW), after 20 seconds the system enables the relative alarm. 4-41 Falco 202 Evo...

  • Page 136: Man Operative Mode

    In APRV the patient breaths on two positive pressure levels not synchronised with the patient's spontaneous breathing. WARNING !! Patient injury hazard If the patient stops breathing, after 20 seconds the system enables the low PAW acoustic and visual alarm (low airway low pressure). 4.6.12 MAN operative mode MANUAL ventilation available in all operative modes.

  • Page 137: Prp Parameters

    PRP parameters In the following chapter you will find a description of available physiological respiratory parameters (referred to from now on as PRP) selectable on Falco 202 Evo lung ventilator. WARNING !! Patient injury hazard Thoroughly read this chapter and the entire manual to make sure you set the PRP correctly.
  • Page 138 VC/VAC operative mode: available PRP parameters.   Select the icon for Reselect the icon see the PRP for see all PRP parameters. parameters. Modifying a PRP parameter (e.g. RR: Respiratory Rate).  Select the RR icon. Note. The bar for RR parameter is displayed.
  • Page 139 (a value that if modified, affects the values of other parameters). The PRP can also be adjusted while the lung ventilator runs, adapting them to the patient's clinical situation. For more information about PRP respiratory parameters, please see on chap. 2.3.5. 4-45 Falco 202 Evo...

  • Page 140: Monitoring Of Respiratory Parameters

    4.7.2 Monitoring of respiratory parameters  Based on the ventilator parameters set by the User and on the patient's characteristics, the lung ventilator is able to monitor and measure a series of an “parameters” values necessary for the patient's clinical evaluation.

  • Page 141: Ventilation Phase

    Stop controls for the ventilation and the message for active alarms. • At the bottom, the Functions to be activated by the user as well as time and status of the power supply are available. 4-47 Falco 202 Evo...

  • Page 142: Ventilation Interruption

    4.8.1 Ventilation interruption • Press ON/OFF, to return in Stand-by mode. • The system will ask you if you want to stop the ventilation (switch to Stand- by mode). YES: stop ventilation. NO: cancel the command. Lung ventilator in Stand-by mode.

  • Page 143: Operative Functions And Graphic Settings

    Select the icon to access the lung ventilator's SETTING MENU. • Select Cancel, to go back to the Stand-by display. NOTE ! The functions that can be enabled from the SETTING MENU are shown in chap. 4.14. 4-49 Falco 202 Evo...
  • Page 144 • Select the icon to access the lung ventilator's ALARM LIMITS. • For ALARM LIMITS, please see on chapter 5 (Alarms). • To go back to the Stand-by display, select Cancel or OK (follow the instructions displayed). 4-50 User manual, DU3104101...
  • Page 145 Flow , PAW / Tidal Volume , PAW / Flow 3. Lung status icon 4. Measures: respiratory parameters. • For GRAPHICs setting, please see on chap. 4.10. • To quit the function, select again the icon GRAPHICs. 4-51 Falco 202 Evo...
  • Page 146 Select the INSP HOLD mode: the system will extend the inspiration time to 20 seconds. The function activation is displayed by the screen and signalled by the yellow LED inside the box, that turns on. Select the EXP HOLD mode: the system will extend the expiration time to 20 seconds.
  • Page 147 The function activation is signalled by the green LED inside to the patient a flow of 6 the box, that turns on. litres/min. WARNING !! Patient injury hazard The Nebulizer activation can increase the oxygen concentration delivered to the patient. 4-53 Falco 202 Evo...
  • Page 148 MAN operative mode By selecting the MAN mode, the system provides the patient with a breath. The breath ventilation parameters depend on the set operative Select the icon to activate mode. The function activation is monitored by the screen and the manual ventilation to signalled by the green LED inside the box, that turns on.

  • Page 149: Graphics Visualization

    4.10.1 Combinations of the graphics displayed WARNING !! Patient injury hazard All figures and examples featured in this chapter are purely informative. Charts: PAW , Flow , Tidal Volume Charts: PAW , Flow Loop: PAW / Tidal Volume Lung status icon 4-55 Falco 202 Evo...
  • Page 150 Charts: PAW Loop: Tidal Volume / Flow , PAW / Tidal Volume Lung status icon Measures: Vte Loop: PAW / Flow , PAW / Tidal Volume Lung status icon Measures: Vti, Vte, PAW Trends 4-56 User manual, DU3104101...

  • Page 151: Modification Charts Combination

    • Available charts: PAW , Flow , Tidal Volume, O , CO • Keep selected the area of the graphic some seconds; the selected area (the violet frame) becomes green. 4-57 Falco 202 Evo...
  • Page 152 • Release; the drop-down menu with the list of the options available appears. • Select Charts: the drop- down menu with the list of the options available appears. • Select CO The CO2 graphic is displayed and it replaces the Tidal Volume graphic.

  • Page 153: Loops Combination Modification

    Available Loops: Tidal Volume / Flow , PAW / Tidal Volume , PAW / Flow. • Keep selected the area of the graphic some seconds; the selected area (the violet frame) becomes green. • Release; the drop-down menu with the list of the options available appears. 4-59 Falco 202 Evo...
  • Page 154 • Select Loops: the drop- down menu with the list of the options available appears. • Select P / F. The PAW / FLOW Loop is displayed and it replaces the PAW / Tidal Volume Loop. The procedure described is applicable to all the LOOPs areas and in all the different visualizations available.
  • Page 155 • Select Vti. The respiratory parameter Vti is displayed and it replaces the PAW / Tidal Volume Loop. The procedure described is applicable to all the MEASURES areas and in all the different visualizations available. 4-61 Falco 202 Evo...

  • Page 156: Trends Visualization

    4.10.4 TRENDS visualization Select the TRENDS visualization to monitor the most significant respiratory parameters on medium - long term. Monitored Respiratory parameters: • Rate • P Insp • PEEP • • The storage capacity for each parameter is 72 hours with sampling at every 4 minutes.

  • Page 157: Events Visualization

    The vertical scrollbar allows to display all the events. The Table of the Events provides the following indications: • Alarm icon • Event date and time indication • Event description: green (lung ventilator operating conditions), red (information on event's alarms) 4-63 Falco 202 Evo...

  • Page 158: Default Parameters

    4.11 Default parameters The screen PATIENT DATA / Default allows the User to restore the Default parameters (Factory set). Restoring “Factory set “ means to set once again the Default parameters of the lung ventilator (MENU, SETUP, PRP, ALARMS limits). Lung ventilator in Stand-by mode.

  • Page 159: Alarms Setup

    Here below the list of the available functions and positioning inside the Graphic User Interface. • Operative mode See on chap. 4.6 • Ventilation status See on chap. 2.3.2 • Patient data See on chap. 4.2 • Password See on chap. 5.1.2 4-65 Falco 202 Evo...
  • Page 160 • Brightness • Energy saving Display • Sound volume • Touch audio • Date Date & Time • Time • Italian, English, German, Turkey, Language Polish, French, Russian, Spanish • Weight (referred to the patient) • Height (referred to the patient) Units •...
  • Page 161 • Nebulizer function See on chap. 4.9 • Operative mode: MAN See on chap. 4.6.12 and chap. 4.9 • Time / Data See on chap. 4.2.2 • Battery / Power supply See on chapter 5 Alarms 4-67 Falco 202 Evo...

  • Page 162: List Of Default Parameters

    4.15 List of default parameters Parameters Adult Child New Born Mode VC/VAC APCV-TV APCV VT (ml) RR (bpm) Inspiratory Pause Trigger (cmH PEEP (cmH Pinsp (cmH Pmin (cmH Pmax (cmH Slope 4-68 User manual, DU3104101...

  • Page 163: Calibration Programs

    CAUTION  The specialist SIARE staff or qualified technical staff, formally authorized by SIARE, must know the full content of this manual (and of the Service manual), before carrying out the operations described below.  The SIARE authorized technician avails of suitable tools and spare parts and is trained to work in compliance with product safety.

  • Page 164: Calibration Programs Displaying

    4.16.2 “ Calibration Programs “ displaying  Set the main switch (placed on the back of the ventilator) to “ I ”.  Make sure that on the lung ventilator keyboard (User commands area) the green led (that indicates the presence of mains power supply) is ON.

  • Page 165: Turbine Characterization

    Characterization Program and the system goes back to the ‘Calibration Programs’ visualization. In order to start the turbine characterization calibration program is necessary the intervention of qualified SIARE personnel or qualified technical personnel authorized by SIARE. 4-71 Falco 202 Evo...

  • Page 166: Expiratory Flow Sensors Calibration

    4.16.4 Expiratory Flow Sensors Calibration The Expiratory Flow Sensors Calibration is necessary in the following cases.  Noted differences are more than 15% (over 100ml) between the set Volume value (VTi - Vte) and the expired Tidal Volume reading (Vte). ...
  • Page 167 At the end of the Expiratory Flow Sensors Calibration phase the system goes back to the Calibration Programs menu.  In case of first calibration, it is suggested to perform this operation after checking the calibration of PEEP and Turbine (see on service manual). 4-73 Falco 202 Evo...
  • Page 168  Select The Expiratory Flow Sensors Calibration check phase starts.  The aim of this procedure is to display and check the Inspiration Flow and Expiration Flow measured values (in l/min) stored during the Expiratory Flow Sensors Calibration phase. The two measured and displayed values should have a numerical value very similar to each other.

  • Page 169: High Altitude Usage ( On - Off )

    (On). Nota. Select or press the encoder knob again; the Usage at High Altitude function is disabled (Off). Select Self Test to go to the SELF TEST phase and escape from Calibration Programs window. 4-75 Falco 202 Evo...

  • Page 170: Vtec ( On - Off )

    4.16.6 VTEc ( On - Off ) The activation of VTEc ( VTEc On ) function is necessary to optimize the displaying of calculation of the Vte parameter displayed during lung ventilator operation.  Select the function (or select and press by the encoder knob).

  • Page 171: Nebulizer Enable ( On - Off )

     NEB function (On) is enabled.  Press again the encoder knob; NEB function is disabled (Off) Select Self Test to go to the SELF TEST phase and escape from Calibration Programs window. 4-77 Falco 202 Evo...

  • Page 172: Screenshoot Enable ( On - Off )

    4.16.8 ScreenShoot Enable ( On - Off ) This option, if enabled, allows the User to store on an USB key an instant image (image saved in bmp format) during the operation of the lung ventilator, (for further details, see on chapter 2).

  • Page 173: Self Test

    4.16.9 Self Test Once the Falco 202 Evo lung ventilator is switched ON, the system (SW) carries out the self-diagnostic tests (Self Test) and checks a series of devices necessary for safe lung ventilator operation.  Select the function (or select and press by the encoder knob).

  • Page 174: Power Off

    The Self Test phase completed successfully. Select OK for displaying the Stand-by screen. Select Cancel for displaying the Supplementary tests screen. 4.17 Power Off  Select the function (or select and press by the encoder knob).  The lung ventilator is switched OFF 4-80 User manual, DU3104101...

  • Page 175: Other Functions

    Calibration page is displayed.  To continue, see the note (ATTENTION) below. WARNING !! Risk of DM failure and/or injuries for the patient  Refer directly to SERVICE Manual.  Contact SIARE or a Centre authorized by SIARE. 4-81 Falco 202 Evo...

  • Page 176: Data Connection (Trend And Events Downloading)

    The system software permits the download of the data stored in the Falco 202 Evo 10.4”. Note! Ask Siare for the dedicated program to transform the stored and downloaded data (see procedure below) into a file that can be read and interpreted by the User.
  • Page 177  The Trend and Events data are saved on the USB drive in TXT format.  Ask Siare for the dedicated program to transform the TXT file into a readable and interpretable file of the User. 4-83 Falco 202 Evo...

  • Page 178: Default Parameters Set

    For more information on the default parameters setup, see chapter 4.11. 4.18.4 Touch Screen set The Falco 202 Evo lung ventilator is equipped with a 15” colour Touch Screen display. In case of Touch Screen system malfunctioning, it is possible to perform calibration of the same system (see on Service Manual).

  • Page 179: Alarms

    ALARMS This chapter illustrates the part of the system relevant to the alarms operation of the Falco 202 Evo (10.4”) lung ventilator (hereinafter called lung ventilator); also, the operating logic and issues for alarms action are taken into consideration. WARNING !! Risk of injury for the user / patient ...

  • Page 180: Displaying And Used Symbols

    Displaying and used symbols 5.1.1 Alarms display area A1 - Alarm area: this area of the monitor provides the following indications.  A text string related to the type of active alarm.  An “alarm bell symbol” indicating the priority and the alarm status. ...

  • Page 181: A1 - Alarm Area

    MAINTENANCE 1000 hours (* a symbol replace the alarm bell image). WARNING !! ( * ) MAINTENANCE 1000 HOURS When this 1000-hour operation is reached, this symbol appears. Contact the Siare Service Center or authorized Siare for preventive maintenance. Falco 202 Evo...
  • Page 182 Gas Sensor alarms  Sampling Line Clogged  No Sampling Line  Replace Adapter  No Adapter  Unspecified Accuracy (……)  Error (..)  No Breaths  Low EtCO  High EtCO  Check the Flow Sensor (……) Characters sequence (…..) has to be considered as an indicator to which the equipment inserts a value in function.

  • Page 183: A2 - Alarms Parameter

    Verify that the pre-set alarm limits are appropriate for the new patient and adjust the alarm limits on values suitable to the new condition of use.  The alarms setting to the range limit could make the alarm not properly working. Falco 202 Evo...

  • Page 184: A3 - General Information Area

    5.1.4 A3 - General information area This area shows the battery charge level and the power supply status (present/absent). Green “BATTERY” symbol: battery completely charge:  with fix symbol the battery is complete charge;  with flashing symbol, the battery is in charging phase. Green “PLUG”...

  • Page 185: A4 - Acoustic Alarm Silencing

    A new alarm silencing will cancel the alarm text only if the alarm conditions is disappeared.  If during the alarm silencing a new high priority alarm occur, the alarm silencing is cancelled and the acoustic signal and the visual texts are activated again. Falco 202 Evo...

  • Page 186: Alarms Setting

    Alarms setting 5.2.1 Setting of ALARMS limits values WARNING !! Risk of injury for the patient Using in the same area more than one medical device having different alarm limits setting, the User could have a potential false misinterpretation. CAUTION Before using the lung ventilator, it is suggested to adjust the parameters necessary for the correct operation of the lung ventilator.
  • Page 187 ( e.g. PAW ).  Select the Alarm Limits to be modified.  The parameter bar is highlighted and the monitoring parameter box on display is activated ( e.g. PAW ). Falco 202 Evo...
  • Page 188  40: High Alarm Limits value set (it is displayed in the PAW parameter box)  Coloured bar: the bar is active to be modified  Scrolling cursor: to be used for setting the parameter value  PAW: PAW parameters ...

  • Page 189: Setting Of Alarms Volume

    SETTING MENU.  Select Display  To go back to the Stand-by displaying, select Cancel The Display page allows to set:  BRIGHTNESS  ENERGY SAVING  SOUND VOLUME  TOUCH AUDIO 5-11 Falco 202 Evo...
  • Page 190  Select the SOUND VOLUME scrolling cursor  Set the SOUND VOLUME  Select YES: to quit from Display page; the set will NOT be saved. NO: it remains in Display page. After modification of SOUND VOLUME value.  Select YES: to quit Display page;...

  • Page 191: Setting Of Default Parameters

    SETTING MENU.  Select Default  To go back to Stand-by page, select Cancel The Default page allows to set:  Trends data Default  Patient data Default  Setting & Ventilation Default 5-13 Falco 202 Evo...
  • Page 192  Select Setting & Ventilation Default  Select RUN  The system requires to confirm the application of default parameters.  Select YES: to quit Default page; the Default Parameters will be saved. NO: it remains in Default page. Possible User’s options. ...

  • Page 193: Alarms Default Parameters Values

    0 - 15 21 - 80 Gas sensor 1.0 - 5.0 On Battery (configurable in: MENU SETUP – Other - Power Enable Failure) Apnea Time (configurable in: MENU 20 sec. SETUP – Other – Apnoea Time) 5-15 Falco 202 Evo...

  • Page 194: Summary Table Of Alarm Characteristics

    Summary table of alarm characteristics 5.3.1 Alarms configurable by user Delay Time Suspendable Alarms Priority Suspendable Inhibition for (s) Low Pressure of HIGH Airways High Pressure of HIGH Airways Low Respiratory 3 patient HIGH Rate breaths High Respiratory 3 patient HIGH Rate breaths...

  • Page 195: System Alarms

    Low Battery HIGH Battery HIGH Disconnected Battery HIGH Overtemperature Battery Charger HIGH Disconnected (Patient) Circuit HIGH Disconnected Low O Supply HIGH if FiO =21% Turbine Failure HIGH Turbine HIGH Overtemperature Turbine HIGH Overcurrent Maintenance 1000 HIGH hours 5-17 Falco 202 Evo...

  • Page 196: Gas Sensor Alarms

    5.3.3 Gas Sensor Alarms Delay Time Suspendable Alarms Priority Suspendable Inhibition for (s) Sampling Line HIGH Clogged HIGH No Sampling Line HIGH Replace Adapter HIGH No Adapter Unspecified HIGH Accuracy HIGH Error HIGH No Breaths HIGH Low EtCO HIGH High EtCO Check the Flow HIGH Sensor...

  • Page 197: Troubleshooting

    WARNING !! If the problem persists, carry out a complete check of the lung ventilator to identify any irregularities. If the problem cannot be resolved, contact the Siare Service Centre or a Centre authorized by Siare. Troubleshooting list 5.4.1 Switch ON failure The lung ventilator does not switch on.
  • Page 198 Initialization phase The initialization phase is not completed. - SELF TEST Verify and intervene in function on the error messages and indications evidenced during the “SELF TEST” phase.  Turbine: if this step is not passed means that the turbine is not running so check if the turbine cable is properly connected and if the turbine is properly powered.
  • Page 199 Turn off and on the lung ventilator and repeat “SELF TEST” phase. If the problem persists, contact the Siare Service Centre or a Centre authorized by Siare. Soft keys and...
  • Page 200 Check that the patient circuit is connected correctly to the lung ventilator and to the patient.  Contact the Siare Service Centre or a Centre authorized by Siare. Low O This alarm is activated when the pressure is insufficient (< 2.7 bar) for pressure the lung ventilator to operate correctly.
  • Page 201  Check the battery connection.  If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. Battery charger The alarm condition is present when the battery does not charge disconnected properly.
  • Page 202  Contact the Siare Service Centre or a Centre authorised by Siare to execute the periodic scheduled maintenance. % high This alarm is activated when the measured concentration of oxygen exceeds the set limit.
  • Page 203 If the lung ventilator works properly perform the expiratory flow sensor calibration.  Contact the Siare Service Centre or a Centre authorised by Siare. Max. Vte / VM This alarm condition occurs in case the Vte is higher than set value.
  • Page 204  Check that nothing is limiting the patient's respiratory capacity.  Contact the Siare Service Centre or a Centre authorised by Siare. PAW low In this condition, the patient circuit + patient system presents a lower resistance than expected or a higher compliance. This causes insufficient ventilation pressure.
  • Page 205 Check that the sensitivity of the Trigger is appropriate to the patient's physiological conditions.  If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. RR low This alarm is activated when the respiratory rate value is lower than the set value.
  • Page 206 Check that the patient circuit is connected correctly to the lung ventilator and to the patient.  Contact the Siare Service Centre or a Centre authorised by Siare. Expiratory flow The user can note indirectly, by monitoring the flow graph, the value...
  • Page 207 Eliminate the leakage and perform again the turbine calibration.  Replace the turbine and perform again the turbine calibration.  If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. Analyzer Malfunctioning. ...
  • Page 208 This page has been added to make front / back copy easier. 5-30 User manual, DU3104101...

  • Page 209: Maintenance

    MAINTENANCE  To guarantee the regular ventilation operation of the Falco 202 Evo (10.4”) lung ventilator for intensive care, emergency and transport (hereinafter called lung ventilator), perform the following maintenance interventions with the recommended frequency.  All interventions must comply with to the practice and protocols in force in each facility.

  • Page 210: Cleaning, Disinfection And Sterilization

     Siare is aware that working procedures can differ considerably from one health care facility therefore it is impossible to indicate specific procedures suitable for every requirement.

  • Page 211: General Indications

     Rinse the parts well with clean hot water (tap water can be used) and leave to dry.  Siare recommends that the components are checked every time they are cleaned and any damaged part should be replaced.  Whenever a part or component is changed, check the functioning of the lung ventilator.

  • Page 212: Disinfection By Immersion (Chemical)

     Do not disinfect, sterilize or re-use disposable products.  Disinfect and sterilize every time an infected patient is ventilated.  In normal conditions, disinfect and sterilize depending on the frequency of the lung ventilator’s use and in any case at least once a month. ...

  • Page 213: Cleaning, Disinfection And Sterilization Table

    The patient circuit can be sterilized by means of steam but this can lead to early wear of the tubes. Yellowing and reduced flexibility are side effects caused by sterilization using steam. Falco 202 Evo...
  • Page 214 WARNING !! Risk of injury for the patient It is necessary to have at least one spare patient circuit in stock for routine use and /or accidental breaks. Dismantle and clean: sterilize in an Before using again, eliminate autoclave, disinfect with steam or any humidity inside the Couplings and chemically.
  • Page 215 On the aim to guarantee patient and User also a minimum damage, Electrical safety it is necessary to keep the power must be promptly eliminated. connections supply cable in perfect conditions. Eventually replacing the whole cable. Falco 202 Evo...

  • Page 216: Sterilization Of Exp V. Monoblock (Exhalation Block With Flow Sensor)

    6.3.1 Sterilization of EXP V. Monoblock (exhalation block with flow sensor) It is possible to sterilize the component with gamma rays or ethylene oxide (ETO). When disinfection is complete, EXP V. Disinfect with steam (93° - 10 minutes) or rinse with running, preferably Monoblock chemically.

  • Page 217: Disposable Bacteria Filter

    “work of breathing” increases).  Immediately replace the filter if it is stained with blood, secretions or other human fluid  Check the expiry date before using on patient.  Change the filter early if nebulisation is done frequently. Falco 202 Evo...

  • Page 218: Periodic Maintenance

    When you require service, please indicate the serial number of the unit and the problem to SIARE or to your authorised technicians.  SIARE assumes responsibility for all provisions foreseen by the law, if the equipment is used and maintained as per the instructions in this manual and the technical manual ...
  • Page 219 The lung ventilator must also be inspected and checked in general and worn parts must be replaced, using the appropriate preventive maintenance kit. Use the appropriate preventive maintenance kit. 6-11 Falco 202 Evo...

  • Page 220: Cleaning, Disinfection And Sterilization Before Use With Another Patient

    All maintenance and/or repair operations require perfect knowledge of the lung ventilator and must therefore only be carried out by highly qualified personnel, specifically trained and formally authorised by SIARE. Inappropriate intervention or unauthorised modifications can compromise safety and cause danger to the patient.

  • Page 221: Repairs And Spare Parts

    SIARE. 6.5.1 Spare parts kit for lung ventilator Code: R209000P1 Spare parts kit for annual maintenance to be used with the Falco 202 Evo (10.4”), code 980104. Code: R209000CL Battery kit to be used with the Falco 202 Evo (10.4”), code 980104.

  • Page 222: Disposal

    6.6.3 Disposal Batteries, accumulators, oxygen cells and electronic parts in general:  do not put them in the fire, explosion risk  do not open them, corrosion danger  do not recharge batteries  do not throw them away with normal waste. The batteries and the accumulators are special waste materials and they must be disposed of in appropriate containers in accordance with local regulations for the disposal of such waste materials.

  • Page 223: Aannex

    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...
  • Page 224 ENVIRONMENTAL CONDITIONS Operating Relative humidity: 30 - 95% non-condensing Temperature: from +10 to +40°C Storage Relative humidity: < 95% Temperature: from -25 to +70°C TECHNICAL DATA Dimensions (W x H x D) 290 x 245 x 215 mm Weight 5,5 Kg Electric power supply 100 - 240Vac / 50 - 60Hz Power Max 60 VA...
  • Page 225 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 patients.
  • Page 226 SIMV Inspiratory time From 0.2 to 5.0 sec. • Tidal volume From 100 to 3000 ml (Adult) • From 50 to 400 ml (Paediatric) • From 2 to 100 ml (Neonatal) I:E ratio From 1:10 to 4:1 Inspiratory pause From 0 to 60 % of the inspiratory time Inspiratory pressure limit Pinsp: from 2 to 80 cmH O (in function of low and high pressure alarm...
  • Page 227 Setting and monitoring of physiological breathing parameters • Visualization of additional graphs and breathing parameters • MENU function for setting operation parameters • Activation of special functions • Visualization of operative mode, clock, date and time functions • Visualization of software version Falco 202 Evo...
  • Page 228 • Calibration Programs Self Test • Turbine Characterization • Expiratory Flow Sensor Calibration • Usage at High Altitude • VTEc • Nebulizer Enable • ScreenShoot Enable MENU function - SETUP • Display (Brightness, Energy Saving, Sound Volume, Touch Audio) • Date &...
  • Page 229 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) analyzer Optional function (Sidestream or Mainstream module available) Falco 202 Evo...
  • Page 230 ALARMS • Alarm types By MENU: with limits set by the operator • By DEFAULT: the operator cannot set them up Alarm default setting Present (Neonatal, Paediatric, Adult) Alarm priority High - Mean - Standby Alarms visualization Max 3 alarms simultaneously; additional alarms, scroll every 3-5 sec. Alarms with limits set up by the operator Pressure of Airways High –...
  • Page 231 Double hose patient circuit • Antibacterial filter for patient circuit • Nebulizer set • Power cable • Vehicular cable for 12 Vdc • O 2 supply hose • O 2 cell Optional Accessories Refer to price list Falco 202 Evo...
  • Page 232 This page has been added to make front / back copy easier. A-10 User manual, DU3104101...

  • Page 233: Preliminary Checks

    Rate check: 15  Pos.  Neg. I:E ratio check: 1:2  Pos.  Neg. PEEP check: (5 – 10 cmH2O)  Pos.  Neg. 10. PAUSE check: 50 %  Pos.  Neg. 11. FiO check: 21% A-11 Falco 202 Evo...
  • Page 234 ALARM CHECKS  Pos.  Neg. 12. High / Low Pressure  Pos.  Neg. 13. High / Low Respiratory Rate  Pos.  Neg. 14. High / Low Expired Vte  Pos.  Neg. 15. High / Low Minute Volume ...

  • Page 235: Ip Classification

    No ingress of dust; complete protection against contact (dust Dust tight tight). A vacuum must be applied. Test duration of up to 8 hours based on air flow. A-13 Falco 202 Evo...

  • Page 236: Second Digit: Liquid Ingress Protection

    A.3.2 Second digit: liquid ingress protection The second digit indicates the level of protection that the enclosure provides against harmful ingress of water. The ratings for water ingress are not cumulative beyond IPX6. A device which is compliant with IPX7, covering immersion in water, need not be compliant with IPX5 or IPX6, covering exposure to water jets.
  • Page 237 1 m immersed in water under the surface of the water, or the depth defined conditions of pressure highest point 150 mm below and time (up to 1 m of the surface, whichever is submersion). deeper. A-15 Falco 202 Evo...
  • Page 238 Protection Level Effective against Details against The equipment is suitable for continuous immersion in water under conditions which shall be specified by the manufacturer. However, with certain types of Test duration: Agreement with equipment, it can mean that Manufacturer. Immersion, water can enter but only in 1 m or more such a manner that it produces...

  • Page 239: Additional Letters

    Further letters can be appended to provide additional information related to the protection of the device. Letter Meaning Oil resistant High voltage device Device moving during water test Device standing still during water test Weather conditions A-17 Falco 202 Evo...

  • Page 240: Pneumatic Diagram

    A.4 Pneumatic diagram A-18 User manual, DU3104101...

  • Page 241: Pneumatic Diagram Legend

    PEEP value is set on 0 or in case the high pressure alarm limit is reached. EV2-NA 12 V pilot electro-valve, normally open, controlled by microprocessor, it has the function to regulate the necessary flow to drive the expiratory valve. A-19 Falco 202 Evo...

  • Page 242: Glossary

    A.5 Glossary Ampere (current intensity measurement unit) Alarm message A message which appears together with an alarm indication; this consists of a basic message indicating the type of alarm. Alarm silencing or Key that stops the acoustic alarm signal for a software value preset suspension key by the last pressing of the key.
  • Page 243 Hectopascal (unit of pressure, approximately equal to 1 cmH Hertz (unit of measurement of frequency, indicating cycles per second). I:E ratio The ratio between inspiratory time and expiratory time International Electro-technical Commission: international organization for the definition of standards. A-21 Falco 202 Evo...
  • Page 244 INSP. PAUSE Inspiratory pause, a manoeuvre started by the User which closes the inspiratory and expiratory valves during the inspiratory phase of a breath. This manoeuvre can be used to determine the static compliance (C) and the resistance (R). International Standards Organization Kilogramme (unit of weight).
  • Page 245 (block or disconnection). In general system errors are not corrected automatically T Exp Expiratory time: duration of the expiratory interval of a breath. A-23 Falco 202 Evo...
  • Page 246 T Insp Inspiratory time: duration of the inspiratory interval of a breath. T pause Pause time: percentage of inspiratory time during which the ventilator maintains a constant airways pressure. Used for calculation of the respiratory mechanics parameters (compliance and resistance). Tidal volume Inspired and expired tidal volume during each breath.

  • Page 247: Emc Tables - Guidance And Manufacturer's Declaration

    It is possible to use the device in all establishments, Conforms IEC 61000-3-2 including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic Voltage purposes. fluctuations/ flicker Conforms emissions IEC 61000-3-3 A-25 Falco 202 Evo...

  • Page 248: A.6.2 Table 2

    A.6.2 Table 2 Immunity aspects The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Test level Electromagnetic environment - Immunity test Compliance level guidance...

  • Page 249: A.6.3 Table 3

    Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: A-27 Falco 202 Evo...

  • Page 250: A.6.4 Table 4

    A.6.4 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 251 APENDIX This chapter contains all the information and data to set the CPR MODE on the Falco 202 Evo 10.4 STEP In the Setting Menu it brings the apnea alarm at least 40 sec. Select the PSV mode and adjust the following parameters •...
  • Page 252 This page is intentionally left blank to facilitate double / sided copy. Manuale Operatore, DU3104001...
  • Page 254 Falco 202 Evo - 10.4” Portable Lung Ventilator Turbine-driven ventilation Touch Screen User’s Manual - 980104 version DU3104101 Revision - 01.02.2019 SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore, 18 Località Crespellano, 40053 Valsamoggia (BO), ITALY Tel.: +39 051 969802 - Fax: +39 051 969366 E-mail: mail@siare.it...

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