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Siare Falco 101 User Manual

Lung ventilator, turbine-driven ventilation
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Falco 101
Lung ventilator
turbine-driven ventilation
User manual

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  • Page 1 Falco 101 Lung ventilator turbine-driven ventilation User manual...

  • Page 3: General Information

    Engineering International Group s.r.l. concerning the Falco 101 lung ventilator and its use is limited to what is indicated in the guarantee supplied. 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 101 lung ventilator (hereinafter called ventilator) and the relative safety regulations.
  • Page 6  SIARE recommends establishing a maintenance and service contract with SIARE or the local authorised service dealer in order to guarantee the scheduled maintenance required to operate the ventilator in a safe and correct manner.  To prevent the risk of fire, keep the ventilator and/or the oxygen tubes away from matches, lit cigarettes and inflammable material, such as anaesthetic gases and/or sources of heat.
  • Page 7  The correct functioning of the ventilator can be impaired if original SIARE spare parts and accessories are not used; the use of other accessories is however allowed only if formally authorised by SIARE in accordance with current safety regulations.
  • Page 8 Before starting the ventilator use, you have to carry out the preliminary checks. WARNING !! Before connecting the ventilator to other electrical equipment not described in this manual, a request for authorisation should be sent to Siare. WARNING !! Qualified staff must make the regulation of ventilation parameters. WARNING !! An auxiliary ventilation system is suggested for the patients for which the ventilator represents a life support.

  • Page 9: Year Of Manufacture

    Shelf life of medical device 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 101 is 10 years. Manufacturer SIARE Engineering International Group s.r.l.

  • Page 10: Electromagnetic Compatibility

    The Falco 101 lung ventilator is designed to operate in the specified electromagnetic environment (see warning below). The customer or the user of Falco 101 lung ventilator should ensure that it is used in such an electromagnetic environment. The ventilator complies with the EN 60601-1-2 regulations...

  • Page 11: Table Of Contents

    Main innovations ....................1-2 1.2.1 Automatic compensation of all ventilation parameters ......1-2 1.2.2 Falco 101: high performance home care ventilator ........1-2 1.2.3 PEEP and leakages compensation ............1-2 1.2.4 Display a LED a 5,6” e visualizzazioni grafiche ........1-2 1.2.5 Small and powerful ..................
  • Page 12 Keyboard with soft keys and encoder knob ............2-6 2.4.1 Encoder knob : use .................. 2-6 2.4.2 Soft keys: use ..................2-7 5,6” LCD Display ....................2-8 2.5.1 Respiratory parameters monitoring ............2-9 2.5.2 Selezione modo operativo ..............2-12 2.5.3 Alarm signals area ................. 2-13 2.5.4 Pressure graphic display ...............
  • Page 13 4.10 MAIN MENU – SETUP ................4-40 4.10.1 Impostazioni di SETUP in MENU PRINCIPALE ........4-41 4.11 CALIBRATRION PROGRAMS ................4-43 4.11.1 Preliminary .................... 4-43 4.11.2 Turbine characterization ................ 4-44 4.11.3 Inspiration flow sensor calibration ............4-45 XIII Falco 101...
  • Page 14 ALARMS ........................5-1 Displaying and used symbols ................5-2 5.1.1 Alarms display area ................. 5-2 5.1.2 A1 - Alarm area ..................5-3 5.1.3 A2 - MAIN MENU / ALARMS parameters ..........5-5 5.1.4 A3 - General information area ..............5-6 5.1.5 A4 - Acoustic alarm silencing ..............
  • Page 15 Technical sheet ....................A-1 Preliminary checks ....................A-7 Glossary......................A-9 EMC tables - Guidance and manufacturer’s declaration ........A-13 A.4.1 Table 1 ....................A-13 A.4.2 Table 2 ....................A-14 A.4.3 Table 3 ....................A-15 A.4.4 Table 4 ....................A-16 Falco 101...
  • Page 16 This page has been left blank intentionally to make front / back copying easier. User Manual, DU3111103...

  • Page 17: Introduction

    “foolproof”, in this way there is no margin for the user to make incorrect or inadequate manoeuvres. The new Falco 101 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

    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 101 to be handy and easy to use in small spaces even during transport. 1.2.6 Battery ...

  • Page 19: Main Technical Characteristics

    The lung ventilator is able to deliver Air/Oxygen mixtures as it could be connected to an external Oxygen source (please, refer to chapter n. 2). Falco 101...

  • Page 20: Correct Operation

    (see on chapter 2). The Falco 101 incorporates a series of sensors for continuous patient monitoring, the most important of which are: ...

  • Page 21: Use Of Falco 101

    PARAMETERS of the lung ventilator. For those who already have the basic knowledge on the functioning of lung ventilators, the use of the Falco 101 lung ventilator is simple and intuitive and for its learning a short training course is sufficient.

  • Page 22: Norms And Standards Regulations

    Norms and standards regulations The Falco 101 lung ventilator is made in accordance with the following norms (and following updates) and it is manufactured according to UNI EN ISO 13485:2004 standards. EN 60601-1:2006/ A1:2011/ A1:2013 Medical electrical equipment - Part 1: General requirements for safety.

  • Page 23: Description

    DESCRIPTION This section of the user manual features the main parts and components of the Falco 101 lung ventilator for Intensive Care, Emergency and Transport (hereinafter called ventilator) and some of its most used functionalities. 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: Keyboard With Soft Keys And Encoder Knob

    Falco 101 – rear view see. 2.1 Side view see. 2.2 Power supply area see. 2.3 Patient connection SEE. 2.4 Keyboard with soft keys and encoder knob see. 2.5 5,7” LCD Display see. 2.6 Main Menu For more information please refer to the paragraphs highlighted on the side.

  • Page 25: Side View

    Side view AIR FILTER : turbine air filter connection (see next chapter) Air intake RS-232 connector ( ODU connector ) : Trend and Events downloading Electric power supply (please, refer to next paragraph) Falco 101...

  • Page 26: Power Supply Area

    The external supply voltage can be provided trough a battery or a supply source having the characteristics specified above. An external battery used as power source for the functioning of the Falco 101 become integral part of this medical system.  I / O : ventilator supply switch ...
  • Page 27 LOW PRESSURE : medical oxygen low pressure connection, max. flow 15 l/min. Patient circuit connector: supplied with unidirectional valve for the using of a circuit with expiratory valve, supplied without unidirectional valve for the using of a whisper “leak” system. Transport handle Falco 101...

  • Page 28: Encoder Knob : Use

    Keyboard with soft keys and encoder knob A control keyboard and an encoder knob are available on the upper side of the ventilator. These components allow quick and easy use of the Falco 101 lung ventilator (referred to from now on as ventilator).
  • Page 29 10 sec., the ventilator set again the previous value (to be modified).  To modify other parameters: turn the knob clockwise or anti-clockwise.  Press the ESC membrane button to go in the STAND-BY screen. Falco 101...

  • Page 30: Soft Keys: Use

    2.4.2 Soft keys: use ALARM RESET Press this key to silence the acoustic warning of an active alarm. After removing the alarm cause, press this key once again to cancel the visual warning displayed on the screen. Press this key to exit the “current” screen and return to the “previous” one.

  • Page 31: 5,6" Lcd Display

    5.7” LCD Display On the front side of Falco 101 lung ventilator for Intensive Care, Emergency and Transport (referred to from now on as ventilator) is a 5.7” LED display that will show all information necessary for patient ventilation. The main featured information are: operating mode selection, respiratory parameters setup and display, visual and acoustic alarm warnings.

  • Page 32: Respiratory Parameters Monitoring

    2.5.1 Respiratory parameters monitoring  Based on the ventilator parameters set by the clinician 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.  At the top of the screen, there is a led indicator that displays the pressure inside the airways in real time.
  • Page 33 It shows the volume value expired by the patient per minute : the unit of measurement is L/min. You can also calculate this value using the formula: current volume (Vti) x respiratory rate (RR). Description Vti : respiratory parameter ml : unit of measurement 520 : measured value 2-11 Falco 101...
  • Page 34 2.5.2 Ventilation modes selection The ventilator has the most modern ventilation modes: pressure controller and pressure assisted. The ventilation modes can be set in the SETUP-Ventilation mode Menu. Modality with expiratory valve enable Pressure controlled ventilation with leak compensation Assisted pressure controlled ventilation, synchronised with patient's breathing with leak compensation.

  • Page 35: Alarm Signals Area

    The role of the alarm signal is to draw the attention of the clinician to the event as well as to inform him on the requested response speed. For more details and information on alarms operation, please see chapter 5 Alarms. 2-13 Falco 101...

  • Page 36: Pressure Graphic Display

    In case of alarm, the system displays the information below:  text string referring to the active alarm  “alarm bell” symbol indicating the alarm priority and status. It is possible to modify the alarms settings ( MENU – ALARMS) even when they are active.
  • Page 37 (PAW curve) and the leakage (%).. Leakage: % The Leakage value measured should be adequate to the ventilation type chosen (pressometric or with whisper system) and between the tolerance defined in the local norms. 2-15 Falco 101...

  • Page 38: General Informations

    2.5.5 General informations This area mainly displays two types of information:  the battery level and the mains power supply status (present / missing)  date (dd.mm.yy) and time  Indication of set hour (dd.mm.yy)  Indication of set date (hh.mm.ss) ...

  • Page 39: Main Menu

    MAIN MENU area to set the basic functions for proper ventilator operation. Before using the Falco 101 lung ventilator for Intensive Care, Emergency and Transport, please use the MENU function to set all necessary items for proper ventilator operation.
  • Page 40  VIEW  LANGUAGE  VOLUME  ENERGY SAVING  BRIGHTNESS  DATE/TIME  EXP. VALVE  NEXT PAGE  PASSWORD  GRAPHIC  TECHNICAL CONTACTS  HOSPITAL CONTACTS  APNEA TIME  PREVIOUS PAGE  CLOSE Please see ALARMS chapter 5. The user has the possibility to check in a mean or in a long period of time the most significant breathing parameters (ref.

  • Page 41: Product Identification Label

    CE mark, complying with European Regulation 93/42/CEE pertaining to medical devices. 0476 RAEE marc, indicates the waste of electronic or electric equipments. 2018 The number indicates the year of production of the equipment. The symbol indicates ‘refer to the instructions for use’ of the equipment. 2-19 Falco 101...
  • Page 42 This page has been left blank intentionally to make front / back copying easier. 2-20 User Manual, DU3111103...

  • Page 43: Preparation For Use

    PREPARATION FOR USE The first section of this chapter describes the installation procedures for the Falco 101 lung ventilator for Intensive Care, Emergency and Transport (hereinafter called ventilator); the second section highlights the preliminary checks to be carried out before using Falco 101.
  • Page 44 WARNING !! Patient/clinician injury hazard The device and all its accessories should be mounted and connected by highly qualified technical staff, suitably trained and authorised by SIARE. Do not connect or disconnect parts or components of the ventilator when it is on or powered.

  • Page 45: Before Use

    [ connector FiO 2 ]. WARNING !! Patient injury hazard When the ventilator is on, the system carries out a series of checks, such as including the O 2 sensor connection (“SELF TEST” phase see cfr. 4.2.1) Falco 101...

  • Page 46: Battery Recharge

    3.2.2 Battery recharge • The ventilator is provided with a battery (NiMh 12Vdc / 4,2Ah) that ensures its operation for at least 4 hours (if in perfect condition; 3 hours, depending on the ventilation parameters), in case the mains power supply is cut off. •...

  • Page 47: Preparation For Use

    A medical use. 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 device.
  • Page 48 WARNING !! Personal injury - physical hazard In order to avoid any electric shock hazard, make sure that the supply cable is connected to an electrical socket with the grounding cable connected.  The lung ventilator complies with the requirements for electro-medical devices detailed on chapter 1.5 ( Norms and standards regulations ).

  • Page 49: 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 50: Patient Circuit Conenction

    3.3.3 Patient circuit conenction Before connecting the device to the patient, it is necessary to choice the patient circuit type and the relevant ventilation mode sto be used (ref 4.7)  Patient circuit with Expiratory Valve: Connect the patient circuit supplied with the ventilator to the INSP.

  • Page 51: Use Of Antibacterial Filters

    3.3.5 Data Connection (Trend and Events downloading ) Connect the interface cable to the ODU connector (RS-232) and to a PC serial port. A dedicated software permits the download and the analysis of the data stored in the lung ventilator. Falco 101...

  • Page 52: Five Wheels Support

    3.3.6 Five wheels support Assembly the trolley using the instructions supplied with the trolley. CAUTION Before positioning the ventilator, be sure that the trolley has been properly mounted, that the screws and bolts are well tighten and that the wheels move properly.

  • Page 53: Connection Of Other Devices

    3.3.7 Connection of other devices Connection of Siare devices In order to connect to the 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 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 54: Lung Ventilator Use

    Lung ventilator use In order to get the best performance, leave the ventilator ON for at least 15 minutes before carrying out the preliminary checks. This operation will allow the system to reach optimal spirometry conditions. 3-12 User Manual, DU31111032...

  • Page 55: Highlights

    (O • connected to a patient simulator at the provided patient circuit terminal. For tests and checks, please use the patient simulator SIARE cod. LS.AB.001 that is equipped with variable resistance and compliance. 3-13 Falco 101...
  • Page 56 Do not use the ventilator if you detect any suspect oxygen leaks from the 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 57: Turn The Lung Ventilator Off

    The ventilator turns on and the automatic “ SELF TEST “ phase begins. • Turbine functioning check and status. • The system pull out the O excess in the device in order to calibrate the 21% O concentration in a proper way. 3-15 Falco 101...
  • Page 58 During “ SELF TEST “ phase, the ventilator software carries out the self-diagnostic tests and checks a series of devices necessary for safe ventilator operation. “ SELF TEST “ : self-diagnostic tests list Turbine • Turbine functioning check and status. Oxygen Emptying •...
  • Page 59 WARNING !! Patient/clinician injury hazard The “ SELF TEST “ phase did not complete successfully. Please see chapter 5 and contact the nearest Siare Support Centre or any other support centres authorised by Siare. However, the system allows you to proceed. Press START.
  • Page 60 The “ SELF TEST “ phase completed successfully.  Go to TESTS ON DEMAND by pressing ESC.  Go to STAND-BY operating mode, by pressing START. 3-18 User Manual, DU31111032...
  • Page 61 • In this mode you can set and/or edit all ventilator parameters and alarms limit relative to the operating mode that you will use on the patient that you want to treat. 3-19 Falco 101...

  • Page 62: Turn The Lung Ventilator Off

    Turn the lung ventilator OFF • STAND-BY operating mode. • Hold the ON-OFF key for few seconds to turn the ventilator OFF.  Turn the lung ventilator OFF.  Press NO: the ventilator goes back to STAND-BY operating mode.  Press YES: the lung ventilator turns OFF.

  • Page 63: Preliminary Checks - Introduction

    • Connect the power supply, and the patient circuit. • Insert and connect the oxygen sensor. • Connect a patient simulator to the patient circuit terminal. • Ventilator ON : STAND-BY operating mode. 3-21 Falco 101...

  • Page 64: Preliminary Checks - Lung Ventilator

    3.7.1 Preliminary checks - Lung Ventilator To carry out the preliminary checks you need to know how the encoder keyboard and the Physiological Respiratory Parameters (referred to from now on as PRP) work. Preliminary checks to be carried out on the ventilator. •...
  • Page 65 20 cmH2O PEEP 5 cmH2O 12 bpm Slope 4. Press the START button: the ventilator begins its cycle. For tests and checks, please use the patient simulator SIARE cod. LS.AB.001 that is equipped with variable resistance and compliance. 3-23 Falco 101...

  • Page 66: Preliminary Checks - Parameters Monitoring

    3.7.2 Preliminary checks - Parameters monitoring • Based on the PRP set by the clinician and on the patient's [patient simulator] characteristics, the lung ventilator is able to monitor and measure a series of values necessary for the patient's clinical evaluation.

  • Page 67: Preliminary Checks - Alarms

     Press and turn the knob: the system will activate the MENU function. • Press the knob once again; the system will display the MAIN MENU screen, SETUP option. 3-25 Falco 101...

  • Page 68: Alarms Check

     Turn the knob: the system will activate the ALARMS option.  Press the knob: the system will activate the ALARMS page. Check the alarms setup and if necessary change the values set, based on the test you want to carry out. •...
  • Page 69 During the ventilation, set a value to obtain a pressure value HIGH INSP. higher than the value of the alarm. VOLUME  The High Inspiration Vt is activated : silence the alarm.  Set again the alarm to its default value. 3-27 Falco 101...

  • Page 70: Conclusions

    Preliminary checks phase failed. • Please see Alarms chapter and/or Trouble Shooting chapter. • Please contact the nearest Siare Support Centre or any other support centres authorised by Siare. WARNING !! Patient injury hazard  Check the alarms set values before connecting a patient to the ventilator.

  • Page 71: List Of Preliminary Checks

    List of preliminary checks Preliminary checks – Introduction 3-19 3.7.1 Preliminary checks - Lung Ventilator 3-20 3.7.2 Preliminary checks - Parameters monitoring 3-22 3.7.3 Preliminary checks – Alarms 3-23 3.7.4 Alarms check 3-24 3.7.5 Conclusions 3-2726 3-29 Falco 101...
  • Page 72 This page has been left blank intentionally to make front / back copying easier. 3-30 User Manual, DU31111032...

  • Page 73: Lung Ventilator Use

    LUNG VENTILATOR USE This chapter shows you how to use the Falco 101 lung ventilator for intensive care, emergency and transport (referred to from now on as ventilator). Thoroughly read this chapter and the entire manual to make sure respiratory parameters and alarm limits are set correctly and choose the most suitable ventilation mode.

  • Page 74: Stand-By Mode

    STAND-BY mode 4.2.1 “ SELF TEST “ phase Set the main switch (placed on the back of the ventilator) to “I”. • Make sure that on the ventilator keyboard (commands area), the green led (that indicates the presence of mains power supply) is on. •...
  • Page 75 In STAND-BY (SET function) you can select the operating mode and set and/or edit all ventilator parameters (PRP) that belong to the operating mode in question. The PRP can also be adjusted while the ventilator runs, adapting them to the patient's clinical situation. Falco 101...

  • Page 76: Keyboard With Soft Key And Encoder Knob Use

    4.2.2 Keyboard with soft key and encoder knob use For the keyboard with soft key and encoder knob methodology of use, please see chapter 2.4. Setting up the MENU language Ventilator in STAND-BY operating mode. • Push the knob and select the MENU box •...

  • Page 77: Setup Screen Parameters Editing Procedure

     turn clockwise (anticlockwise) to select the new value  press the knob to confirm. Press ESC to exit the SETUP screen and go back to STAND-BY mode. Wait for the system to return to STAND-BY screen automatically. Falco 101...

  • Page 78: Setting The Patient Data

    Setting the PATIENT DATA Ventilator in STAND-BY operating mode. • Press the encoder knob turn and select the MENU function. • Press the knob to confirm your choice. • The system will display the MAIN MENU screen, SETUP parameters. • Turn the knob to select the PATIENT DATA option.

  • Page 79: Procedure For Setting The Patient Data

    Turn the knob to enter “the second letter” of the patient Name (first the upper-case letters, then the lower-case letters). Press the knob to confirm and turn it again to proceed with entering the rest of the patient's Name. Falco 101...
  • Page 80 To save the first parameter, Name (and the others) you have to scroll through all characters spaces available for each parameter. After setting the Patient's Name the clinician can proceed in the same manner to fill in the entire PATIENT DATA sheet. After entering all patient identification data, select the CLOSE box and press the encoder.

  • Page 81: Erasing The Patient Data

    Press the knob to confirm your choice. • The system will display the PATIENT DATA ERASE page. To exit the PATIENT DATA ERASE screen.  Press the ESC soft key.  Wait for the system to return to STAND-BY screen automatically. Falco 101...

  • Page 82: Setting Up The Alarms

    Setting up the ALARMS Ventilator in STAND-BY operating mode. • Press the encoder knob turn and select the MENU function. • Press the knob to confirm your choice. • The system will display the MAIN MENU screen, SETUP parameters. • Turn the knob to select the option ALARMS.

  • Page 83: Operating Modes And Prp Parameters

    In the following chapter you will find a description of available physiological respiratory parameters (referred to from now on as PRP) and the operating modes selectable on Falco 101 lung ventilator. WARNING !! Patient injury hazard Thoroughly read this chapter and the entire user’s manual to make sure you set the correctly and choose the most suitable ventilation mode.

  • Page 84: Operative Modes With Expiratory Valve Enabled

    4.7.2 Operative modes with expiratory valve enabled Ventilator in STAND-BY operating mode. • Press the encoder knob turn and select the MENU function. • Press the knob to confirm your choice. • The system will display the MAIN MENU screen, SETUP parameters.
  • Page 85 During the inspiratory phase, the ventilator generates a flow that could be set (Slope). When the airways pressure control value is joined (Pinsp), that pressure level is maintained constant by the ventilator up the the end of the breathing act that could be set changing (RR). 4-13 Falco 101...
  • Page 86 4.7.2.2 APCV operative mode Assisted pressure controlled ventilation, synchronised with patient's breathing with leak compensation. The system displays all PRP relative to the set operating mode. APCV is a pressure controlled ventilation, synchronised with the patient's breathing with leak compensation. With this parameters configuration, APCV is a pressure controlled ventilation, synchronised with the patient's breathing, during which the system generates a patient ventilation at a pre-set inspiratory pressure (Pinsp), a pre-set flow (Flow), a calculated I:E ratio and a settable respiratory...
  • Page 87 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. 4-15 Falco 101...
  • Page 88 4.7.2.3 PSV operative mode Assisted pressure support ventilation with guaranteed safety respiratory rate, set by the clinician (Apnea Back Up) with leak compensation. The system displays all PRP relative to the set operating mode. PSV is an assisted type of ventilation with pre-set pressure support (PS) with guaranteed safety respiratory rate set by the clinician in case of patient apnea (RR bk) and with leak compensation.
  • Page 89 If the patient does not trigger (spontaneous breathing during the apnea time set in MAIN MENU - SETUP), the system activates the APNEA 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). 4-17 Falco 101...
  • Page 90 4.7.2.4 PSV-TV operative mode (Volume Targeted) Pressure support ventilation with guaranteed current volume and guaranteed safety respiratory rate set by the clinician (Apnea Back Up). The system displays all PRP relative to the set operating mode. PSV-TV is an assisted pressure support ventilation with guaranteed current volume and guaranteed safety respiratory rate set by the clinician in case of patient apnea (RR bk).
  • Page 91 If the patient does not trigger (spontaneous breathing during the apnea time set in MAIN MENU - SETUP), the system activates the APNEA 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). 4-19 Falco 101...
  • Page 92 4.7.2.5 P-SIMV operative mode Pressure-targeted synchronised intermittent mandatory ventilation. The system displays all PRP relative to the set operating mode. P-SIMV is a synchronised intermittent mandatory ventilation, during which the 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 93 The graphic shows how the SIMV operating 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. 4-21 Falco 101...
  • Page 94 4.7.2.6 APNEA BACK-UP Apnea BACK-UP is a safety function available in three of the operating modes: PSV, PSV-TV and CPAP. The apnea BACK-UP function activates if the patient, ventilated in one of the modes above, stops breathing. After a pre-set time (Apnea Time) in the MAIN MENU - SETUP, will appear the relative alarms and the system automatically starts ventilating the patient.

  • Page 95: Operative Modes With The Whisper System (Leak System)

    • The system will display the MAIN MENU screen, SETUP parameters. • Enter in the menu SETUP-EXPIRATORY VALVE • Press the knob to confirm your choice. • The system will display the EXP. VALVE screen. 4-23 Falco 101...
  • Page 96 4.7.3.1 CPAP operative mode Positive continuous pressure applied on the airway. The system displays all PRP relative to the set operating mode. CPAP is a spontaneous positive pressure ventilation at continuous flow. In this operating 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 97 (Trig. E). This is made setting the inspiration flow maximum peak percentage when the inspiratory phase should end. During the inspiration phase the IPAP pressure value set is joined, then during the expiratory phase the EPAP value will be joined.. 4-25 Falco 101...

  • Page 98: Physiological Respiratory Parameters ( Prp )

    4.7.4 Physiological respiratory parameters ( PRP ) The physiological respiratory parameters must be set by the clinician in STAND-BY mode before activating the necessary operating mode. The system allows you to set default PRP (MAIN MENU - DEFAULT PARAMETERS) suited for ventilating an adult patient. WARNING !! Patient injury hazard Depending on the chosen ventilation mode, the same PRP can be a dependent variable (that varies depending on other parameters...
  • Page 99 Percentage of the inhaled flow with regard to the maximum peak where the inspiratory phase ends and the expiratory phase begins. Tr. I (L/min) (cmH Flow level (pressure) for detecting the patient spontaneous breathing. Vti (ml) Inspired tidal volume guaranteed for each breath. 4-27 Falco 101...

  • Page 100: Ventilation Phase

    Ventilation phase Before starting the ventilation you have to:  carry out all ventilator hardware connections (medical gases, power supply, patient circuit, ……..)  carry out the preliminary checks (please see chapter 3.6)  set the language and the patient data ...

  • Page 101: Ventilation Interruption

    To stop the ventilator, hold the ON-OFF key for several seconds. • The system will ask whether to remain in STAND-BY or to shut down.  Press the ENTER key to turn the ventilator off.  Press the ON/OFF key : the ventilator returns to STAND- 4-29 Falco 101...

  • Page 102: Graphical Settings And Operating Functions

    Graphical settings and operating functions During the ventilation, the clinician can intervene using the graphical user interface, by selecting the options in the lower side on the screen. Select the MENU function using the encoder knob to access the ventilator's MAIN MENU (please see 4.10) where you can find all the functions displayed in the figure.
  • Page 103 2.4. In the second page of the SETUP menu it is possible to choice GRAPHIC and set the track of the pressure curve. • Line • Area 4-31 Falco 101...

  • Page 104: Main Menu

    By selecting the MENU function you can view the MAIN MENU page and set the functions necessary for proper ventilator operation. Before using the Falco 101 lung ventilator for intensive care, emergency and transport, please use the MENU function to set all necessary items for proper ventilator operation.

  • Page 105: Main Menu - Trends

    4 minutes. • Use the encoder knob to select the TRENDS box (the TRENDS box changes color). • Press the knob, on the display will appear the page TRENDS. • The yellow arrows show the active work area. 4-33 Falco 101...
  • Page 106 1. PRP curves (graphic), viewed in pairs 2. Vertical bar that shows the references movement in time. 3. PRP, selectable in pairs. 4. References over time on 72 hours with sampling at every 4 minutes. TRENDS view Press the knob: •...
  • Page 107 (e.g. Vm - PEEP): the system displays the trend of the parameters values. • Press ESC to exit the TRENDS screen and go back to STAND-BY screen. • Wait for the system to return to STAND-BY screen automatically. 4-35 Falco 101...

  • Page 108: Main Menu - Events

    4.9.5 MAIN MENU – EVENTS Select the EVENTS function to monitor the information on the ventilator operation over time. The monitored event refer mainly to the alarms (active alarms) and the various operating conditions of the lung ventilator (POWER ON, POWER OFF, STAND-BY). The system can register up to 100 events, including the alarms.
  • Page 109 Turn the knob clockwise (anticlockwise) to view the EVENTS saved in the table. • Press ESC to exit the EVENTS screen and go back to STAND-BY. • Wait for the system to return to STAND-BY screen automatically. 4-37 Falco 101...

  • Page 110: Main Menu - Patient Data

    4.9.6 MAIN MENU - PATIENT DATA To set the parameters in the patient data option please see 4.4 PATIENT DATA. 4.9.7 MAIN MENU - PATIENT DATA ERASE To delete the patient data, please see 4.5 PATIENT DATA ERASE. 4.9.8 MAIN MENU - DEFAULT PARAMETERS Select the DEFAULT PARAMETERS function to restore the lung ventilator DEFAULT PARAMETERS : ( Factory - SET ).

  • Page 111: Main Menu - Close

    Select the CLOSE box to exit the MAIN MENU and go back to STAND-BY view or to patient ventilation view. If the clinician does not select any function in the MAIN MENU the system returns automatically to the previous display. 4-39 Falco 101...

  • Page 112: Main Menu - Setup

    MAIN MENU – SETUP 4.10 Select the MENU function to access the MAIN MENU screen and a series of functions such as SETUP, essential for setting up the ventilator operation. • Use the encoder knob to select the MENU box (the MENU box changes color).

  • Page 113: Impostazioni Di Setup In Menu Principale

    From 1 to 10 • • High Frequency From 10 to 70 • • Min. Insp. Volume From 2 to 249 • • Max. Insp.Volume From 5 to 2500 • • Min. FiO2 From 20 to 98 4-41 Falco 101...
  • Page 114 • • Max. FiO2 From 21 to 99 • • Maximum Leak (l/min) From 1 to 150 • • Power Supply Fault Alarm Enable • Alarm Disable • Command to go back to the previous Close screen • Trend parameters •...

  • Page 115: Calibratrion 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. ...

  • Page 116: Turbine Characterization

    4.11.2 Turbine characterization • Put the main switch of the ventilator (on the back side of the device) in position n. “I”. • Check on the ventilator keyboard if the green led is turned on (presence of mains). • In order to access to the turbine characterization (calibration), press and keep pressed for some seconds the keys (in sequence), ALARM RESET and ON-OFF .

  • Page 117: Inspiration Flow Sensor Calibration

    To activate the characterization (calibration) program of the turbine it is necessary the intervention of SIARE authorized personnel or technical qualified personnel, authorized by SIARE. For additional information on the procedure please refer to the SERVICE manual. If the user or the authorized technician don’t active or choice any CALIBRATION PROGRAM, after some seconds, the system goes automatically in SELF TEST phase.
  • Page 118 To start the ventilation press the start key To activate the inspiration flow sensor calibration program it is necessary the intervention of SIARE authorized personnel or technical qualified personnel, authorized by SIARE. For additional information on the procedure please refer to the SERVICE manual.

  • Page 119: Alarms

    The parameters and the characteristics (activation time, presence or lack of an acoustic and/or luminous indicator) and the possible user’s actions respect to the alarm signals (silencing, suspend, inhibit) are described here below. Falco 101...

  • Page 120: 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 string of text relevant to the type of active alarm.  An “alarm bell” symbol which indicates the priority and the alarm state. A2 - MAIN MENU / ALARMS parameter.

  • Page 121: A1 - Alarm Area

    Apnea time (configurable in MAIN MENU - SETUP area) • Low Battery 50% Rem. • Low Battery 25% Rem. • Low Battery 10 Min. Rem. • Battery Disconnected • Battery Overtemperature • (Patient) Circuit Disconnected • Turbine Failure • Turbine Over-Temperature • Turbine Over-Current Falco 101...
  • Page 122 Priority / alarm status: “ alarm bell symbol “ Medium priority Yellow bell Suspended alarm Yellow bell crossed through High priority Red bell Suspended alarm Red bell crossed through The “bell” alarm symbol assumes a colour based on the priority and status of the activated alarm.

  • Page 123: A2 - Main Menu / Alarms Parameters

    The ventilators used in the same health environments can have different preset configurations of alarm limits. Verify that the preset alarm limits are appropriate for the new patient and adjust the alarm limits on values suitable to the new condition of use. Falco 101...

  • Page 124: 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, indication of the battery charge level: • with fix symbol the battery is complete charge; • with flashing symbol the battery is in charging phase. Green “PLUG”...
  • Page 125 Pushing further the RESET button 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 101...

  • Page 126: Alarms Setting

    Alarms setting 5.2.1 Setting of ALARMS limits values Before using the ventilator it is suggested to use the MENU function to adjust the items necessary for the correct operation of the equipment. During operation it is possible to adapt the alarm setting in function of the patient clinical situation.
  • Page 127 Turn clockwise (counter-clockwise) to select another alarm to be modified. Press the ESC soft key to return to the MAIN MENU. Wait for the system to return automatically to STAND-BY visualization. Press the ON-OFF key to return to STAND-BY visualization. Falco 101...

  • Page 128: Setting Of Alarms Volume

    5.2.2 Setting of ALARMS volume The Volume parameter allows the adjustment of the volume of acoustic alarms signals at any priority level. Press and turn the encoder knob and select “MENU”. Press the knob to confirm; the “MAIN MENU” is displayed Press the encoder to access to the displaying of SETUP page contents.

  • Page 129: Setting Of Default Values

    Press the ESC soft key to return to the MAIN MENU. Wait for the system to return automatically to the STAND-BY visualization. Press ON-OFF key to return to STAND-BY visualization. 5.2.3 Setting of DEFAULT values The DEFAULT PARAMETER allows setting the standard factory parameters. 5-11 Falco 101...
  • Page 130 Press and turn the encoder knob and select “MENU”. Press the knob to confirm; the “MAIN MENU” is displayed The “MAIN MENU” page is displayed. Turn clockwise the encoder knob to select the DEFAULT PARAMETERS function. • Press the encoder to access to the DEFAULT PARAMETERS function.

  • Page 131: Troubleshooting

    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. 5.3.1 Troubleshooting list Switch ON failure The lung ventilator does not switch on.
  • Page 132 • Switch the lung ventilator OFF and then switch back ON.  If the problem persists, contact the Siare Service Centre or a Centre authorized by Siare. (Patient) Circuit This alarm conditions occurs in case of disconnection of the patient disconnected circuit (missed Vte detection for three times).
  • Page 133 • Check the battery connection. • If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. Battery This alarm condition is present when the battery pack internal overtemperature temperature pass the 75°C. The ventilator go in STAND-BY mode.
  • Page 134 (according to the operative mode selected: Volume/Flow, Rate, I/E, Trigger). • Contact the Siare Service Centre or a Centre authorised by Siare. Max. Vti / VM This alarm condition occurs in case the Vti is higher than set value. •...
  • Page 135 • Check that nothing is limiting the patient's respiratory capacity. • If the problem persists, 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.
  • Page 136 Check that the patient circuit is connected correctly to the lung ventilator and to the patient. • If the problem persists, contact the Siare Service Centre or a Centre authorised by Siare. Apnea In this condition, no spontaneous respiratory activities is detected (RR = 0).

  • Page 137: Maintenance

    MAINTENANCE  To guarantee the regular ventilator operation of the Falco 101 lung ventilator for intensive care, emergency and transport (hereinafter called ventilator), perform the following maintenance interventions with the recommended frequency.  All interventions must be conform to the practice and protocols in force in each facility.

  • Page 138: Cleaning, Disinfection And Sterilization

     Siare is aware that working procedures can differ considerably from one health structure to another: it is therefore impossible to indicate specific procedures that are suitable for all requirements.

  • Page 139: General Indications

     Rinse the parts well with clean hot water (tap water can be used) and leave to dry.  Siare recommends that the components should be checked every time they are cleaned and any damaged parts should be replaced. ...

  • Page 140: 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 according to how often the ventilator is used and in any case at least once a month. ...

  • Page 141: 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 101...
  • Page 142 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. Couplings and Dismantle and clean: sterilize in an Before using again, eliminate connectors autoclave, disinfect with steam or any humidity inside the...

  • Page 143: 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 144 Frequency Component Procedure / Action Several times a day Patient circuit Check for any water collection, drain and clean the / according to local tubes when necessary. practice and Patients filter Check for wear. standards Condensation trap Check for any water collection, drain and clean filter when necessary.

  • Page 145: Cleaning, Disinfection And Sterilization Before Use With Another Patient

    All maintenance and/or repair operations require perfect knowledge of the 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 146: Repairs And Spare Parts

    3/6 months, depending on the storage temperature. See the technical sheet in the Appendix A. Repackaging and shipment If it is necessary to return the equipment to SIARE for any reason, we suggest using the original packaging to prevent damage to the equipment during shipment.

  • Page 147: Disposal

    The components of the electronic boards can contain compounds, such as arsenic, lead, cadmium, mutagenic and cancerogenous agents, that are a health hazard if dispersed in the environment in an uncontrolled way. For further information contact the relevant authorities for environmental and public health monitoring. 6-11 Falco 101...
  • Page 148 This page has been left blank intentionally to make front / back copying easier. 6-12 User Manual, DU3111102...

  • Page 149: Aannex

    Falco 101 lung ventilator. Technical sheet GENERAL DATA 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.

  • Page 150: Patient Connections

    < 30 dB LUNG VENTILATOR FUNCTIONAL FEATURES Use destination Falco 101 is a lung ventilator for use in home care and transport with patients affected by respiratory diseases and it is suitable for ventilation of adult and paediatric patients. •...
  • Page 151 Monitor Module with TFT LED display Dimensions 5,7” Display keyboard Lateral keyboard for rapid access of functions and encoder knob for: • selection, set up and confirmation of physiological breathing parameters • selection and direct activation of functions Falco 101...
  • Page 152 • Displaying and settings Operative Mode setting • Visualization of alarm messages and signals • Setting and monitoring of physiological breathing parameters • Visualization of additional graphs and breathing parameters • MENU function for setting operation parameters • Activation of special functions •...
  • Page 153 FiO 2 concentration High – Low Electric power supply Alarm occurs in case of failure of external power supply Apnoea Low Respiratory Rate (Apnoea BACK-UP function) System alarms Level (charge) Battery at 50% Level (charge) Battery at 25% Battery level (low) 10 Minutes Falco 101...
  • Page 154 Disconnected battery Yes / No Battery over temperature Indication of exceeding the temperature limits inside the battery Circuit disconnected Indication of patient circuit disconnected Turbine fault Signals in case of a blower fault condition Turbine over temperature Indication of exceeding the temperature limits inside the turbine Turbine over current Indication of exceeding the current limits inside the turbine Maintenance...

  • Page 155: Preliminary Checks

    Preliminary checks See the table here below: List of preliminary checks. Falco 101...
  • Page 156 Ref. Description Measured values Result Notes  Pos.  Neg. External view  Pos.  Neg. Marks presence  Pos.  Neg. Software version Rel. ________  Pos.  Neg. SELF TEST  Pos.  Neg. Axoustic alarm  Pos. ...
  • Page 157 Respiratory parameters setting  Pos.  Neg. Pressure graphic  Pos.  Neg. TRENDS - EVENTS  Pos.  Neg. Setting language _______  Pos.  Neg. Electrical test report EC certificate  Pos.  Neg. Working hours _______ Falco 101...

  • Page 158: Glossary

    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 by the suspension key last pressing of the key.
  • Page 159 All the operations necessary to maintain the equipment in working order or to carry out cleaning, maintenance, repairs, modifications, revisions and performance checks. If the MANUAL key is pressed in PSV mode, the system delivers pressure controlled ventilation to the patient. Indication of the mean airways pressure Falco 101...
  • Page 160 Medium priority alarm As defined by the international standards organizations, this is an abnormal condition which requires immediate intervention to ensure the safety of the patient. During a medium priority alarm, the corresponding yellow signal flashes. A medium priority acoustic alarm signal is emitted (a repeated series of three tones) and an alarm message is displayed in the upper part of the screen.
  • Page 161 Intermitted ventilation by assisted positive pressure: a ventilation mode which allows to deliver controlled ventilations only (started by the patient, by the ventilator or by operator) basing on current settings. Direct current voltage Ventilations per Respiratory rate unit (Resp/min). minute (bpm) Falco 101...

  • Page 162: Emc Tables - Guidance And Manufacturer's Declaration

    EMC tables - Guidance and manufacturer’s declaration A.4.1 Table 1 Emissions Emissions test Conformity Electromagnetic environment – guidance The appliance use RF energy only for its internal function. RF Emissions Group 1 Therefore, its RF emissions are very low and are not likely to Cispr 11 cause any interference in nearby electronic equipment.

  • Page 163: A.4.2 Table 2

    (>95 % dip in U (>95 % dip in U for 5 seconds for 5 seconds Magnetic power frequency fields Power frequency should be that of a typical magnetic field 3 A/m 3 A/m commercial or hospital EN 61000-4-8 environment. Falco 101...

  • Page 164: A.4.3 Table 3

    A.4.3 Table 3 Immunity aspects at R.F. 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 Compliance Immunity test Electromagnetic environment - guidance level...

  • Page 165: A.4.4 Table 4

    1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Falco 101...
  • Page 166 This page has been left blank intentionally to make front / back copying easier. A-18 User Manual, DU3111103...
  • Page 168 Falco 101 Lung ventilator turbine-driven ventilation User’s Manual versione DU3111103 980111 SIARE ENGINEERING INTERNATIONAL GROUP s.r.l. Via Giulio Pastore, 18 Località Crespellano, 40053 Valsamoggia (BO), ITALY Tel.: +39 051 969802 - Fax: +39 051 969809 E-mail: mail@siare.it Web: www.siare.it...

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