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HERSILL VITAE 40 Instructions For Use Manual

Emergency and transport ventilator
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VITAE 40
Emergency and Transport Ventilator
Instructions for use

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Summary of Contents for HERSILL VITAE 40

  • Page 1 VITAE 40 Emergency and Transport Ventilator Instructions for use...
  • Page 3 (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission of HERSILL. This manual may be revised or replaced by HERSILL at any time and without notice. Ensure that you have the most current applicable version of this manual; if in doubt, contact HERSILL.

  • Page 4: Table Of Contents

    Contents SYMBOLS ..........................10 SAFETY INFORMATION ......................12 OVERVIEW ..........................20 3.1..........................20 NTENDED USE 3.2..........................21 AIN FEATURES DESCRIPTION ........................... 24 4.1..........................24 ONNECTIONS 4.2......................25 PLANE AND SUPPORT 4.3............................26 CREEN 4.4............................26 EYPAD 4.4.1.
  • Page 5 5.1.1. Mains supply ............................. 30 5.1.2. Battery supply ........................... 31 5.2............................33 AS SUPPLY 5.3....................... 35 ATIENT BREATHING CIRCUIT 5.3.1. Disposable patient breathing circuit....................37 5.3.2. Reusable patient breathing circuit ....................38 5.3.3. NIV ..............................39 5.3.4. Options for oxygen-therapy and capnography ................. 40 5.4.
  • Page 6 6.4.1. Heading area ............................. 63 6.4.2. Monitoring area ..........................63 6.4.2.1. Graphic monitoring area ......................64 6.4.2.2. FiO2 monitoring area ........................ 65 6.4.2.3. Parameters monitoring area..................... 66 6.4.3. Buttons bar ............................67 6.5. CPR / O2FLOW ....................68 INTERFACE SCREEN 6.6.
  • Page 7 7.2.7. Adaptive Pressure with Volume Guaranteed - Synchronized Intermittent Mandatory Ventilation (APVG-SIMV) ..............................95 7.2.8. APVG-SIMV with Pressure Support (APVG-SIMV-PS) ............... 97 7.3......................99 RESSURE CONTROLLED MODES 7.3.1. Pressure Controlled Ventilation (PCV) .................... 101 7.3.2. Pressure Controlled - Assisted Controlled Ventilation (PCV-ACV) ..........103 7.3.3.
  • Page 8 10.2..........................130 ASES ALARMS 10.3........................131 ECHNICAL ALARMS 10.3.1. Ventilator technical alarms ......................131 10.3.2. CO2 analyzer (IRMA) technical alarms ................... 133 10.4..........................136 THER AULTS CONFIGURATION ........................ 137 INTERFACE ......................... 140 COMMUNICATIONS ......................142 MAINTENANCE ........................144 14.1.
  • Page 9 14.2.3.1. Battery replacement ....................... 153 14.2.3.2. Fresh air intake filter replacement ..................154 14.2.3.3. Mains electric cords maintenance ..................156 14.2.3.4. Gas supply hoses maintenance ....................156 14.3......................... 156 OFTWARE RESET REFERENCES (OPTIONS, ACCESSORIES, CONSUMABLES AND SPARES) ........158 TECHNICAL SPECIFICATIONS ....................

  • Page 10: Symbols

    1. Symbols Symbol Title Explanation Follow instructions for Consult Vitae 40 User and service documentation for medical backboard device IP classification: IPX4 = Protected against solid objects > 1 mm in diameter. IP44 degree of protection IP4X = Protected against water projections against the against ingress of envelope from any direction.
  • Page 11 The applied parts and the CO2 analyzer connector of the TYPE BF Applied Part Vitae 40 are protected against defibrillator. Manufacturer Vitae 40 is manufactured by Hersill entirely in the facilities (name and address) located in Madrid - Spain Date of manufacturing Year and month (yyyy-mm)

  • Page 12: Safety Information

    2. Safety information _________________________________________________________________________________ WARNING: Indicates a potentially hazardous situation which, if not avoided, WARNING could result in serious injury or death. CAUTION: Indicates a potentially hazardous situation which, if not avoided, CAUTION may result in minor or moderate injury to the patient or in damage to the equipment or others.
  • Page 13 • Do not use the ventilator in explosive environments. Such use might cause an explosion. • VITAE 40 is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. • Don’t lubricate O fittings, cylinder valves and pressure reducers (grease, oils and others).
  • Page 14 VITAE 40 only must be used under the supervision of qualified medical WARNING personnel, trained in ventilation techniques, so that assistance can be provided immediately in the event of any malfunction. This ventilator in intended to be continuously attended by an operator.
  • Page 15 The Ventilation modes with Pressure support (PS), the CPAP mode and the WARNING O2-flow mode are only suitable for a spontaneously breathing patient. The therapy supplied to the patient can be adversely affected by the gas WARNING added by the use of a pneumatic nebuliser. It is the responsibility of the responsible organization to ensure that the WARNING oxygen source is compatible with the rated range of pressure, flowrate and...
  • Page 16 Use only water-based lotions or salves that are oxygen compatible before WARNING and during oxygen therapy. Never use petroleum-based or oil-based lotions or salves to avoid the risk of fire and burns. Do not add any attachments or accessories to the ventilator that are not WARNING intended for use in combination with the ventilator as stated in the instruction for use of the ventilator or accessory, as the ventilator might nor...
  • Page 17 The ventilator accuracy can be affected by the gas added to the ventilator WARNING breathing system by use of a pneumatic nebulizer. No modification of the equipment is allowed without manufacturer WARNING authorization. If it is modified, appropriate inspection and testing must be conducted to ensure safe use.
  • Page 18 VITAE 40 must not be used in or near to nuclear magnetic resonance CAUTION equipment. Electromagnetic interferences that exceed the levels specified in the EN CAUTION 60601-1-2 may result in malfunction. This is possible to occur near cell phones, defibrillators, electro-surgery units and other electronic devices.
  • Page 19 Use only the original parts and accessories recommended in these CAUTION instructions. If third-party items are used, functional failures may occur, and biocompatibility requirements may also not be met. Please note that in such cases the manufacturer will decline any claims. The ventilator breathing systems, their parts and accessories are validated CAUTION for use with specific ventilators.

  • Page 20: Overview

    Intended use 3.1. VITAE 40 is a portable ventilator intended to provide controlled and assisted, as well as for invasive and noninvasive ventilation to patients with a body weight of 3 kg and over; It includes advanced ventilation in CPR, oxygen therapy, monitoring and capnography.

  • Page 21: Main Features

    Main features 3.2. - Ventilation modes: (for more detail see Chapter 7) • Volume modes: o Volume Controlled ventilation: VCV, VCV-ACV, VCV-SIMV, VCV-SIMV-PS o Adaptive Pressure with Volume Guaranteed ventilation APVG, APVG-ACV, APVG-SIMV, APVG-SIMV-PS. • Pressure modes: o Pressure Controlled ventilation (+NIV): PCV, PCV-ACV, PCV-SIMV, PCV-SIMV-PS (biPAP) o Continuous Positive Airway Pressure &...
  • Page 22 - Monitoring: (for more detail see Chapter 6) • Ventilation curves: Real time: P/t, F/t, V/t, CO2/t Loops: V-F, P-V, F-P. Trends: ; VMe, Compliance, EtCO2 • Volumetric capnography curves : VCO2 (SBCO2), V’CO2 trend, V’alv trend. • Ventilation parameters: P , VTe, F, Fspont., VM, VTi, InCO2, EtCO2, Pplateau, Pavg, Cdyn, O2 consumption, Leak rate (VTi vs.
  • Page 23 - Main technical specifications: (for more detail see Chapter 16) Power supply: 10 - 30 V DC (0,6 A). Optional: AC/DC (100 - 240 V / 50-60 Hz) Gas supply: O2: 2,7 - 6,9 bar (internal gas consumption < 0,1 L/min) Battery autonomy: 5 hours (in standard certified ventilation conditions) Screen:...

  • Page 24: Description

    4. Description Connections 4.1. All the input and output connections are located at the bottom of the device. Patient Gas Output: 22-15 conical port to connect the corrugated tube of the patient circuit. Airway Flow-P Sensor ports: circle - hexagon ports to connect tubing from the patient flow sensor. CO2: SubD9 port to connect the IRMA analyzer (Masimo O2 gas input: O2 DISS port to connect an Oxygen source at a range pressure of 2,7 to 6,9 bar, with the next flow capacity (according to ISO 80601-2-84):...

  • Page 25: Back-Plane And Xg Support

    Back-plane and XG support 4.2. Battery compartment (1). A manual screw (2) allows to access to the battery. The XG support (3) is an accessory to anchor the ventilator. It is tested up to 30g acceleration (vibrations and impact) in the 6 axis.

  • Page 26: Screen

    Screen 4.3. VITAE 40 is equipped with a high resolution, sunlight readable, TFT color 4,3” (95 x 54 mm) screen. See operation screens in chapter 6 for detailed description. Keypad 4.4. VITAE 40 has a membrane-keypad with integrated LEDs for interactive options.

  • Page 27: Ventilation Keys

    4.4.1. Ventilation keys The upper bar contains: 3 keys for the ventilation modes (see chapter 7): - VOLUME: VCV, VCV-ACV, VCV-SIMV, VCV-SIMV-PS; APVG, APVG-ACV, APVG-SIMV, APVG-SIMV-PS. - PRESSURE: PCV, PCV-ACV, PCV-SIMV, PCV-SIMV-PS (biPAP); CPAP (+NIV); CPAP-PS (+NIV) (PSV). - MANUAL. - CPR/O FLOW: Access to CPR modes (see chapter 8) and O2 Flow + Capnography (see chapter 9).

  • Page 28: Navigation Keys

    4.4.2. Navigation keys The arrows to navigate through the values, options and menus; and the [OK] to confirm the selected value. The LEDs lights on the [OK] flashes to ask for confirmation and stops flashing if it isn’t confirmed before 20 seconds. If OK is not pushed, the parameter returns to its previous value.

  • Page 29: Utility Keys

    4.4.3. Utility keys Silence alarms: To mute any alarm sound for 2 minutes, but the visual alarm message on the screen doesn’t disappear. During the silence time (2 min), the red LED from this key is lighting. Configuration: To give access to the configuration and calibration tools (see chapter 11). On/Off: Switch-on and Shut-down (asking for confirmation during 5 seconds).

  • Page 30: Installation

    5. Installation Electrical supply 5.1. VITAE 40 operates with a 7,2V 2500mAh NiMH battery pack rechargeable and/or from 10-30 V 5.1.1. Mains supply The DC cable must be connected through the Jack connector on the bottom plane. There is available, as an accessory, an external 100-240 V (50-60Hz) –...

  • Page 31: Battery Supply

    5.1.2. Battery supply The battery pack, supplied with the equipment, must be installed in the back-plane compartment (see chapter 4.2). The bi-color (yellow-red) LED indicates the battery/charge status. When the ventilator is ON, in the upper bar, the icon indicates the charge level. The battery should be charged at least every 3 months.
  • Page 32 BATTERY STATUS INDICATORS Charging With ventilator ON: Battery LED yellow fixed and Icon growing. With ventilator OFF: Battery LED yellow fixed. Discharging With ventilator ON: Battery LED Off and Icon fixed. (not charging) With ventilator OFF: Battery LED Off. Fully charged With ventilator ON: Battery LED Off and Icon fixed full.

  • Page 33: Gas Supply

    Gas supply 5.2. VITAE40 can be supplied with medical Oxygen from 2,7 to 6,9 bar (39 to 100 psi). Before managing a Oxygen cylinder and relating accessories, read carefully WARNING the safety recommendations related in chapter 2 (safety information - Explosion and fire hazard).
  • Page 34 4. Take in the full cylinder and open its manual valve careful and slowly for an instant to blow away any particles of dust (hold the valve opening away from anybody to avoid that any flying particles cannot injure yourself or other people). Close the cylinder valve. 5.

  • Page 35: Patient Breathing Circuit

    It can be the filter supplied by Hersill or a different one with a resistance under 4 cmH O at 60 L/min (see explanation below).
  • Page 36 An HME filter should be able to provide a minimum of 30 mg/L. CAUTION Procedure to connect the patient breathing circuit: 1. Mount the circuit hose onto the corresponding 22/15 connection on the ventilator. 2. Attach Flow-P sensor tubes (circle and hexagon) to the corresponding nipples in the ventilator. 3.

  • Page 37: Disposable Patient Breathing Circuit

    5.3.1. Disposable patient breathing circuit The disposable patient breathing circuit is the most compact and the safest way to connect the ventilator to the patient (the tubing, the patient valve and the Flow-P sensor are glued, to avoid connection errors). There are available adult and pediatric models, their only difference...

  • Page 38: Reusable Patient Breathing Circuit

    5.3.2. Reusable patient breathing circuit The reusable patient breathing circuit is conceived to be completely sterilizable (see procedure in chapter 14.1.3), manufactured in polysulfone and silicone materials (see references in chapter 15) and designed to be easily disassembled / assembled. There are available adult and pediatric models, their only difference is the Flow-P sensor model (see references in chapter chapter 15).

  • Page 39: Niv

    5.3.3. In NIV (non-invasive ventilation), the patient breathing circuit (disposable or reusable) must be connected to the supplied HME filter, and this filter must be connected to the NIV mask. There is available NIV masks in different sizes (see references in chapter 15). Regarding to the patient breathing circuit, the NIV mask substitutes the NOTE intubation piece, all the other parts are exactly the same and assembled in...

  • Page 40: Options For Oxygen-Therapy And Capnography

    VITAE 40 is compatible with any nasal canula specific for HFNOT. To operate the VITAE 40 in those functions different to mechanical ventilation, it is necessary to install parts different to the patient breathing circuit as shown below:...
  • Page 41 * For long term therapy, an active/passive humidifier-heater can be inserted in any of these configurations.
  • Page 42 (ref. 0220013) For capnography, if the filter isn’t installed between the patient and the IRMA CO2 adaptor, this adaptor should be disposed after patient use. For further understanding on the O2 flow and capnography possibilities with VITAE 40, consult Chapter...

  • Page 43: Co2 Analyzer

    CO2 Analyzer 5.4. The ventilator Vitae 40 has CO monitoring (IRMA mainstream from Masimo technology), as an optional accessory (see references in chapter 15). According to the standard ISO 80601-2-84, an emergency and transport NOTE ventilator should be equipped with CO2 monitoring, integral to the ventilator or connected to the ventilator.
  • Page 44 The respiratory gas measurements are obtained through the transparent NOTE windows of the airway adapter. There are two different IRMA CO2 airway adapters: 1.- for Adult/Pedriatric and 2.- Infant patients for minimizing the dead space (adult adapter adds 6 mL of dead space).
  • Page 45 During the operation with the IRMA activated, the power consumption is NOTE much higher and the battery autonomy could by significantly reduced (up to 50%). Consequently, consider having the auxiliary pluscel battery (see reference in chapter 15). According to Masimo recommendations, the CO2 analyzer IRMA: WARNING - Meets the ISO 80601-2-55 requirements.
  • Page 46 - Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 mL dead space to the patient circuit. - Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow resistance. - Do not use the IRMA airway adapter with inhalers or nebulized medications as this may affect the light transmission of the airway adapter windows.

  • Page 47: Set-Up Of The Co2 Analyzer

    (there is only one able position, it will click into place when properly seated). 3. In the VITAE 40 screen upper bar will appear the ‘CO2’ icon. 4. Around 10 seconds after the switch-on, a green LED lights in the analyzer to show it is ready for use. In other case any...
  • Page 48 5. The capnometry (EtCO2) will be displayed in the screen parameters. In addition, it is possible to display the Graph for the Capnography, the CO2 trend and even the Volumetric Capnography (see chapter 6.6); to select these options use the button [INTERFACE] (see chapter 12). 6.

  • Page 49: Zeroing The Co2 Analyzer

    5.4.2. Zeroing the CO2 analyzer Zeroing should be performed every time the IRMA airway adapter is NOTE replaced, and whenever an offset in gas values or an unspecified gas accuracy message is displayed. Procedure: Set up the IRMA CO2 analyzer according to the steps 1 to 4 from the chapter 5.4.1 (without any patient connected to the analyzer).

  • Page 50: Alarms Of The Co2 Analyzer

    5.4.3. Alarms of the CO2 analyzer For a complete alarms handling understanding of the ventilator VITAE 40, see the Alarms and Troubleshooting in chapter 10. Moreover, the CO2 analyzer status is displayed in its LED with different colors: INDICATION STATUS...

  • Page 51: Replacing The Co2 Airway Adapter

    5.4.5. Replacing the CO2 airway adapter The respiratory gas measurements are obtained through the transparent windows in the side of the airway adapter. There are two different IRMA CO2 airway adapters for 1.- Adult/Pediatric and 2.- Infant patients, for minimizing the dead space, especially with neonates (adult adapter adds 6 mL of dead space). The IRMA airway adapter is designed as a non-sterile single patient use disposable for both Adult/Pediatric and Infant applications;...

  • Page 52: Operation

    6. Operation Switching on 6.1. Pushi On/Off. During the launching: ng the key It’ s displayed on the screen the software version. All the LEDs in the touchpad are lighted (useful to verify the LEDs). An alarm beeps for a moment (useful to verify the speaker). and immediately the unit changes to the Patient selection screen.
  • Page 53 If it is chosen an erroneous selection (choosing ADULT when installing a WARNING pediatric Flow-P sensor or choosing PEDIATRIC when installing an adult Flow-P sensor), the ventilation calculations would be erroneous and could cause damage to the patient. In this case it will be necessary to turn-off and switch-on the equipment newly, to select the correct.

  • Page 54: Standby Screen

    Standby screen 6.3. After choosing ADULT or PEDIATRIC, the interface enters to the Standby screen. If it is pushed the OK button directly (with the VENTILATION option pre- selected), the unit access directly to the Ventilation screen (see chapter 6.4). It’s pre-selected the VENTILATION option to allow to start the ventilation NOTE before than 10 seconds from the switch-on, but t...

  • Page 55: Checklist

    6.3.1. Checklist The checklist is according to the international standards recommendations, its purpose is to avoid errors in the patient breathing circuit configuration and assembly. The checklist has a previous screen to allow up to three different configurations (3 different circuit assemblies).
  • Page 56 The checklist procedure should be pursued by any user before to attempt to CAUTION ventilate the patient. When choosing the desired option, the interface enters to the specific checklist screen, that contents an explanatory drawing, and three buttons: Video: To view the assembly video for the selected patient breathing circuit.

  • Page 57: Autotest

    6.3.2. Autotest After to assemble the patient circuit and verify it according to the Checklist, it must be performed the Autotest, to verify, in less than 1 minute, the proper operation of the ventilator and the patient circuit assembly. Autotest procedure requires interaction with the user: After pushing...
  • Page 58 Cause Action EEPROM failure Internal failure. Contact Technical Service No battery Install battery Peripheral communications failure Internal failure. Contact Technical Service Altitude sensor failure Internal failure. Contact Technical Service Altitude out of range Altitude out of range Temperature above specifications Temperature above specifications Temperature below specifications Temperature below specifications...
  • Page 59 EV O2 range below requirement Internal failure. Contact Technical Service. EV V range below requirement Internal failure. Contact Technical Service. EV O2 unstable at low flow Internal failure. Contact Technical Service. EV V unstable at low flow Internal failure. Contact Technical Service. Flow measure piece inverted Flow measure piece inverted or tubing inverted.

  • Page 60: Ventilation Screen

    Configuration – Vent Settings (see Chapter 11). The VITAE 40 allows multiple ventilation modes; all of them are grouped in three root modes: VOLUME, PRESSURE and MANUAL (see chapters 7.2, 7.3 and 7.1 respectively), each one accessible from the three corresponding buttons in the keypad;...
  • Page 61 When the user pushes a ventilation button in the keypad ([VOLUME], [PRESSURE] or [MANUAL]), the LED associated to this button will start to flash and the lower area (buttons bar) of the interface will change presenting the parameters associated with the new mode (taking the default factory settings). In this way the operator can adjust the configuration of the new mode before starting it.
  • Page 62 The ventilation screen is configurable by using the key [INTERFACE] (see chapter 12). The ventilation screen is divided in three principal areas: - Heading area (upper). Monitoring area (central). Buttons bar (lower area)

  • Page 63: Heading Area

    6.4.1. Heading area The heading (upper bar) shows different information: Battery charge / status. Ventilation mode. Metronome icon (if activated). CO2 icon (if present). Patient: Adult / Pediatric. Alarm identifier (ID): the name of the main alarms and the number of total active alarms.

  • Page 64: Graphic Monitoring Area

    6.4.2.1. Graphic monitoring area In the left side of the monitoring area is shown the selected graph. The default graph (factory setting) is the Pressure in real time (P/t). It is possible to change the selected graph by choosing between different options of real-time curves, loops and trends.

  • Page 65: Fio2 Monitoring Area

    NOTE volume less than 50 mL, if it isn’t equipped with an internal O2 monitor (the VITAE 40 estimates the FiO2 through indirect flow measurements, therefore it’s accuracy is out from the ISO 80806-2-55 requirements), It should be connected an additional O2 monitoring equipment for measurement of the inspiratory oxygen concentration, equipped with an alarm system that includes high O2 level and low O2 level alarms condition.

  • Page 66: Parameters Monitoring Area

    6.4.2.3. Parameters monitoring area The right side of the monitoring area shows 4 parameters (2 fixed and 2 configurable)*: 2 fixed parameters: PIP (Pressure inspiratory peak from the last cycle) [mbar] VTe (Tidal vomume expired) [mL] 2 configurable parameters: DATA 1 (the upper) and DATA 2 (the lower). The default parameters (factory setting) are: DATA 1 = VMe (minute volume expired) DATA 2 = Freq (if CO2 monitor is Off) or EtCO2 (if CO2 monitor is On).

  • Page 67: Buttons Bar

    6.4.3. Buttons bar Depending from the selected mode there are active buttons (blue) and inactive buttons (grey): parameter button VOLUME PRESSURE MANUAL Tidal volume [mL] Pressure Inspiratory P insp [mbar] Respiratory Rate Freq [1/min] I:E relation PEEP PEEP [mbar] Inspiratory Pause Pause [% Ti] Ramp time...

  • Page 68: Cpr / O2Flow Interface Screen

    CPR / O2FLOW interface screen 6.5. After confirmation in the [CPR/O FLOW] key in the touchpad, the unit access to the corresponding interface screen (see Chapters 8 and 9 for these particular operation modes). The operator must select the chosen option by using the navigation keys of the keypad and confirm by pushing either [OK] or the blinking [CPR/O2]...

  • Page 69: Volumetric Capnography

    Volumetric capnography 6.6. The graphic representation of the loop from Exhaled CO2 vs Volume, is usually called ‘Volumetric Capnography’ or loop VCO2, also called SBCO2 (single breath CO2). In addition to the VCO2 graph, it is possible to show the two most useful volumetric capnography trends: V’CO2 (volume of CO2 eliminated per minute) and V’alv (minute volume alveolar) (in order to help the graphical analysis, together with the V’alv graph is also displayed the VMe graph).
  • Page 70 The screen displays the selected graph (in the left) and the selected batch of data (in the right). • Graph area (left): o The VCO2 (SBCO2) graph shows: The CO2 measurements loop from the last expiration cycle, in yellow. The CO2 measurements loop from the reference expiration cycle, in dotted gray *. The slope of phase III, in pink.
  • Page 71 • Data area (right): Depending on the [Data VCO2] selection button: o Data VCO2 Volumes: PIP, VTe, EtCO2, ViCO2, VeCO2, VCO2, V’CO2 o Data VCO2 Dead spaces: PIP, VTe, EtCO2, VDaw, VDalv, VDphys, VD/VT o Data VCO2 Estimate (Bohr): PIP, VTe, EtCO2, PACO2, FECO2, PECO2, VD/VTb o Data VCO2 Vent.
  • Page 72 * The ventilator starts without any reference cycle. The reference cycle is recorded by the operator by selecting the button [Ref. Cycle] and pushing the key [OK]. The system will record the last ventilation cycle as the reference cycle, and from now on its curve and its variables will be shown in gray color. Fig: V’alv trend + Data VC02 Vent Minute...
  • Page 73 Equations for VCO2 data: parameter calculation Tidal volume expired Measured (see value in Analysis graph) Ventilation frequency in VCV or PCV: Fr= mandatory freq. /min in CPAP / CPAP-PS: Fr= measured freq. Minute volume expired VMe = VTe x Fr EtCO2 End tidal CO2 Measured (see value in Analysis graph)
  • Page 74 PACO2 Mean alveolar partial pressure of Measured (see value in Analysis graph: mmHg CO2 pressure at 50% of phase III) VD/VT Ratio Dead space vs Tidal volume VD/VT = (PaCO2-PECO2) / PaCO2 x 100 (Enghoff) VD/VTb Ratio Dead space vs Tidal volume VD/VTb = (PACO2-PECO2) / PACO2 x 100 (Bohr) VDaw...
  • Page 75 VCO2 analysis graph: - Phase I: Dead space airway; expired gas contents of the respiratory system. - Phase II: Transition from upper to lower airways. Represents changes in perfusion. - Phase III: Alveolar gas exchange. Represents the gas distribution at alveolar level.

  • Page 76: Ventilation Pause

    Ventilation pause 6.7. Vitae40 is equipped with an operator-controlled means to pause the ventilator in expiration. When pushing OK on the [Vent Pause] button, placed to the right in the buttons bar (the last button), the ventilation is paused at the end of the expiration time, and will be maintained in pause until: - The end of the 60 seconds count-down.

  • Page 77: Event Log

    Event log 6.8. The ventilator Vitae 40 stores all the events corresponding to: alarms, changes in ventilation parameters and autotest results in a non-volatile memory. The log is accessed through the menu [CONFIGURATION] + [Tools] + [Event Log]. Upon entering, the current event log is displayed, without interrupting ventilation.

  • Page 78: Switching Off

    When pushing the On/Off button in the keypad, at the bottom of the screen is displayed OK to confirm the shut-down. - CANCEL If OK isn’t confirmed, VITAE 40 continues working in the previous mode. The switch-off can be cancelled by choosing CANCEL.

  • Page 79: Ventilation Modes

    7. Ventilation modes Manual ventilation 7.1. The Manual ventilation is an ‘operation mode’ rather than a ‘ventilation mode’ itself. This ‘operation mode’ supplies a Bolus in Volume controlled Ventilation (VCV) when the operator selects [Bolus¡] in the buttons bar and push the key [OK]. Parameters Default value Range...
  • Page 80 Manual ventilation or Manual operation mode is a useful mode of pausing mechanical ventilation (alternative mode to expiratory pause) in certain clinical procedures (examples: permitting defibrillator ECG analysis with deflated lungs, measuring respirophasic blood pressure variations, suctioning the airway, turning the patient), much better than disconnecting the ventilator from patient or turn-off the ventilator, because you get a minimum disruption of ventilation thanks to: a) When changing from any ventilation mode to Manual, the bolus adopts the ventilation settings (VT + Pause + PEEP + FiO2 in volume modes and PEEP + FiO2 in pressure modes).

  • Page 81: Volume Controlled Modes

    APVG-ACV: APVG - Assisted Controlled Ventilation o APVG-SIMV: APVG - Synchronized Intermittent Mandatory Ventilation o APVG-SIMV-PS: APVG-SIMV with Pressure Support In volume controlled modes, VITAE 40 monitors the difference from NOTE the VT setting to the VTe measured. When the difference is greater than 40% for at least 3 cycles, a medium priority alarm is generated.
  • Page 82 Parameters (buttons bar) Standard value Range (increment) Adult Pediatric Tidal Volume 500 mL 150 mL 50 – 1500 mL (10) Respiratory Rate Freq 12 /min 22 /min 3 - 80 /min I:E relation 5:1 - 1:8 PEEP PEEP 0 mbar 0 mbar 0 - 30 mbar Inspiratory Pause...

  • Page 83: Volume Controlled Ventilation (Vcv)

    7.2.1. Volume Controlled Ventilation (VCV) Every cycle has a fixed time, depending on the programmed frequency. The inspiratory and expiratory time is fixed only by the programmed I: E ratio. To ventilate in this mode, the user must press the [VOLUME] key and select the option VCV in the left button bar.

  • Page 85: Volume Controlled - Assisted Controlled Ventilation (Vcv-Acv)

    7.2.2. Volume Controlled - Assisted Controlled Ventilation (VCV-ACV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (VCV bolus). The flow trigger window corresponds to the whole programmed expiratory time.

  • Page 87: Volume Controlled - Synchronized Intermittent Mandatory Ventilation (Vcv-Simv)

    7.2.3. Volume Controlled - Synchronized Intermittent Mandatory Ventilation (VCV-SIMV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (VCV bolus). The flow trigger window corresponds to the last 25 % of the programmed expiratory time.

  • Page 89: Vcv-Simv With Pressure Support (Vcv-Simv-Ps)

    7.2.4. VCV-SIMV with Pressure Support (VCV-SIMV-PS) The difference between VCV-SIMV and VCV-SIMV-PS is that the patient will be ‘supported’, with a pressure support, when a spontaneous inspiration occurs before the Flow Trigger Window (1). This ‘support’ is established by the patient and he finishes it when the inspiration flow drops below 75% of the maximum inspiration flow (2).

  • Page 91: Adaptive Pressure With Volume Guaranteed Ventilation (Apvg)

    Although this is a volume-pressure combined ventilation mode and the pressure curve is similar to pressure ventilation modes, from the Vitae 40 user interface (keypad and ventilation display screen), APVG will be grouped in the [VOLUME] ventilation modes.

  • Page 93: Adaptive Pressure With Volume Guaranteed - Assisted Controlled Ventilation (Apvg-Acv)

    7.2.6. Adaptive Pressure with Volume Guaranteed - Assisted Controlled Ventilation (APVG-ACV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (APVG bolus, 1 and 2 of the following graph).

  • Page 95: Adaptive Pressure With Volume Guaranteed - Synchronized Intermittent Mandatory Ventilation (Apvg-Simv)

    7.2.7. Adaptive Pressure with Volume Guaranteed - Synchronized Intermittent Mandatory Ventilation (APVG-SIMV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (APVG bolus).

  • Page 97: Apvg-Simv With Pressure Support (Apvg-Simv-Ps)

    7.2.8. APVG-SIMV with Pressure Support (APVG-SIMV-PS) The difference between APVG-SIMV and APVG-SIMV-PS is that the patient will be ‘supported’, with a pressure support, when a spontaneous inspiration occurs before the Flow Trigger Window (1). This ‘support’ is established by the patient and he finishes it when the inspiration flow drops below 75% of the maximum inspiration flow (2).

  • Page 99: Pressure Controlled Modes

    Pressure controlled modes 7.3. o PCV: Pressure Controlled Ventilation (+ Non-Invasive Ventilation (+NIV)) o PCV-ACV: PCV - Assisted Controlled Ventilation (+NIV) o PCV-SIMV: PCV - Synchronized Intermittent Mandatory Ventilation (+NIV) o PCV-SIMV-PS (biPAP): PCV-SIMV with Pressure Support (+NIV) o CPAP: Continuous Positive Airway Pressure Ventilation (+NIV) o CPAP-PS: CPAP with Pressure Support (+NIV and Apnea Ventilation) NIV only can be used in pressure-controlled modes.
  • Page 100 Parameters (buttons bar) Standard value Range (increment) Adult Pediatric Pressure Inspiratory P insp 20 mbar 10mbar 5 - 60 mbar Respiratory Rate Freq 12 /min 22 /min 3 - 80 /min I:E relation 5:1 - 1:8 PEEP PEEP 0 mbar 0 mbar 0 - 30 mbar Ramp Time...

  • Page 101: Pressure Controlled Ventilation (Pcv)

    7.3.1. Pressure Controlled Ventilation (PCV) Every cycle has a fixed time, depending on the programmed frequency. The inspiratory and expiratory time is fixed only by the programmed I: E ratio. The inspiration will only be cut prematurely if it is exceeded by 15% Pinsp. To ventilate in this mode, the user must press the [PRESSURE] key and select the mode PCV in the left button bar.

  • Page 103: Pressure Controlled - Assisted Controlled Ventilation (Pcv-Acv)

    7.3.2. Pressure Controlled - Assisted Controlled Ventilation (PCV-ACV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (PCV bolus). The flow trigger window corresponds to the whole programmed expiratory time.

  • Page 105: Pressure Controlled - Synchronized Intermittent Mandatory Ventilation (Pcv-Simv)

    7.3.3. Pressure Controlled - Synchronized Intermittent Mandatory Ventilation (PCV-SIMV) In patients with spontaneous breathing, the mandatory bolus will be synchronized with the spontaneous inspiratory efforts when the trigger is activated (during the flow trigger window); therefore, every inspiratory effort, higher than the set trigger, will create an assisted breath (PCV bolus). The flow trigger window corresponds to the last 25 % of the programmed expiratory time.

  • Page 107: Pcv-Simv With Pressure Support (Pcv-Simv-Ps Or Bipap)

    7.3.4. PCV-SIMV with Pressure Support (PCV-SIMV-PS or biPAP) The difference between PCV-SIMV and PCV-SIMV-PS is that the patient will be ‘supported’, with a pressure support, when a spontaneous inspiration occurs before the Flow Trigger Window (1). This ‘support’ is established by the patient and he finishes it when the inspiration flow drops below 75% of the maximum inspiration flow (2).

  • Page 109: Cpap (+Niv)

    7.3.5. CPAP (+NIV) Continuous Positive Airway Pressure (CPAP) is a ventilation mode for patients with spontaneous breathing, which consists in the application of a constant pressure (defined by the operator) throughout the respiratory cycle (inspiration and expiration). To ventilate in this mode, the user must press the [PRESSURE] key and select the mode CPAP in the left button bar.

  • Page 111: Cpap With Pressure Support (+Niv And Apnea Ventilation) (Cpap-Ps Or Psv)

    7.3.6. CPAP with Pressure Support (+NIV and Apnea Ventilation) (CPAP-PS or PSV) CPAP-PS or PSV (pressure support ventilation) is a ventilation mode that adds synchronization (trigger) to the CPAP ventilation mode. When a trigger happens, the ventilator starts a supported breath. The difference between CPAP and the CPAP-PS (or PSV) is that the patient will be ‘supported’, with a pressure support, when two of the next conditions occur: a) A spontaneous inspiration occurs.

  • Page 113: Cpr Modes

    8. CPR modes Beyond all available ventilation modes, VITAE 40 includes additional specific NOTE tools for CPR ventilation and advanced CPR assistance. To access the CPR modes menu, press in the keypad [CPR / O2 FLOW] to enter the CPR/O2Flow interface screen (the O2 Flow is discussed in chapter 9).

  • Page 114: Cpr Ventilation

    CPR ventilation 8.1. 8.1.1. CPR-PCV Pressure Controlled Ventilation (PCV) with CPR specific settings and restrictions according to the CPR Guidelines: o Fixed settings (according to the CPR Guidelines): ▪ Pmax = 60 cmH ▪ Frequency = 10 /min. ▪ PEEP = 0 ▪...

  • Page 115: Cpr Assistants

    CPR Assistants 8.2. This is a set of wizards for CPR procedures assistance (according to the valid CPR Guidelines, with software updates availability). There are 3 optional interface screens (they differ in the interface): Real-time graphs (A), Trends graphs (B) and bar graphs (C). Change between these by using the key [INTERFACE] (see chapter 12).
  • Page 116 B. Interface for trend graphs: The only difference to the real-time graphs is the lower area, that represents the trend for each parameter. C. Interface for bar graphs: The differences to the real-time graphs is the upper left and central area, that is substituted by a big number representing the massage count.
  • Page 117 In the CPR Assist modes, it is possible to modify some ventilation related parameters: • Settings: (accessible in the upper right buttons bar from each interface): VT (default 500mL for adult and 150 mL for pediatric). Pmax (default 60 cmH2O for adult and 40 mbar for pediatric). CPAP * (default 0 mbar).

  • Page 118: Cpr Semi-Auto

    8.2.1. CPR Semi-Auto This is an assistant wizard for CPR 30-2 (adult) or 15-2 (pediatric) with manual ventilation trigger, and with metronome (visual and acoustic). A count-down (30-0 or 15-0) metronome will mark the rhythm of the massage at 110 per minute. The metronome has an audible beep, with higher tone and red number during the last 5 beeps, and a continuous sound at the end.

  • Page 119: Cpr Auto

    8.2.2. CPR Auto This is an assistant wizard for CPR 30-2 (adult) or 15-2 (pediatric) with automatic ventilation trigger, and with metronome (visual and acoustic). The metronome will mark the rhythm of the massage at a frequency of 110 /min. There are three differences with regards to the CPR Semi-Auto mode: There is a massage detection (via Flow-P sensor).

  • Page 120: Cpr Auto-Compressor

    8.2.3. CPR Auto-Compressor This is an assistant wizard for CPR with automatic ventilation trigger synchronized with automatic chest compressor. There is a huge difference with regards to the CPR Auto mode: There isn’t a count-down, and there isn’t a 30-2 / 15-2 consideration; in Auto-Compressor mode the system is always looking for a pause of 1 second in the massage to launch 1 bolus (see respiratory pattern explanation below).

  • Page 121: O2 Flow (+ Capnography)

    To provide these functions it must be assembled the proper circuit and accessories; see the kits and options in Chapter 5.3.4. To provide the O2 Flow (+Capnography) function, the ventilator VITAE 40 includes an O2 – AIR blender, able to supply flows from 3 to 80 L/min with a FiO2 from 40 to 100%.
  • Page 122 Additional advantages of the O2 Flow: - The capacity to supply O2-AIR mixtures with simply an O2 source, taking Air from the ambient through the intake filter. - The capacity to switch to a ventilation mode without changing the equipment. - The timer and graphic trend display to manage the therapy.
  • Page 123 The maximum O2/Air flow able to be supplied is limited by the patient tube NOTE lumen; The higher the flow the higher the pressure in the VITAE 40 gas outlet; to avoid O2 waste by the safety valve (due to over-pressure), the VITAE 40 monitors the pressure and limits the maximum flow accordingly.
  • Page 124 A highly restrictive tubing doesn’t allow high HFOT specific tubing allows high flow therapy flow Notes: (1) Capnography (CO2) option must be included and enabled in the ventilator purchase order. (2) O2 Flow measurements are indicated in STPD conditions while all the ventilation parameters (patients system variables) are indicated in BTPS conditions (accordingly to the flow-meter standards and to the ISO 80601-2-84:2018 Particular requirements for basic safety and essential performance of emergency and transport ventilators);...

  • Page 125: Alarms And Troubleshooting

    10. Alarms and troubleshooting The alarms are shown in the upper bar of the screen; bar changes from this NOTE blue to red, dark yellow or light yellow depending of the highest priority active alarm. Each alarm ID number is displayed preceded by ‘E’ (ex.‘E101’). The alarm sound corresponds to the highest priority active alarm, and its NOTE ‘song’...

  • Page 126: Ventilation Alarms

    Ventilation alarms 10.1. Alarm Prior. Cause Action Range Pre- Vent. defined mode APNEA 101 HIGH Not detected trigger Check Flow-P sensor 10 - 60 CPAP, (flow in the Flow-P correctly installed. sensor) during the Apnea Check patient circuit. time. 102 HIGH The setting High Increase the setting.
  • Page 127 Alarm Prior. Cause Action Range Pre- Vent. defined mode 104 MED Setting Insp pressure Check patient circuit. (Pins) not reached. Adjust vent settings. REACHED Inspiration time short. Calibrate/replace Maximum pressure FlowP and its tubing. reached. Leakage in Change Fresh gas circuit.
  • Page 128 Alarm Prior. Cause Action Range Pre- Vent. defined mode 107 MED The VTe is lower than 75 Adjust vent settings. % of the setting (for VT> Check leaks in patient REACHED 100 mL) or 50 % (for circuit. Calibrate FlowP. APVG Vt<= 100 mL) repeatedly.
  • Page 129 Alarm Prior. Cause Action Range Pre- Vent. defined mode CIRCUIT 111 MED VTi is lower than 40 % of Check leaks in patient LEAKAGE the ventilator outlet circuit. Calibrate FlowP. volume repeatedly. Replace FlowP and its Faulty or leak in FlowP. tubing.

  • Page 130: Gases Alarms

    Gases alarms 10.2. Alarm Priority Cause Action Range Pre- Vent. defined mode ETCO2 HIGH The EtCO2 is higher than Check patient 1 - 75 HIGH the upper limit setting condition. Check CO2 [mmH (adult) repeatedly. analyzer. Check the patient circuit (pediat) (patient valve).

  • Page 131: Technical Alarms

    Technical alarms 10.3. 10.3.1. Ventilator technical alarms Alarm Priority Cause Action Range Pre- Vent. defined mode 301 HIGH Gas Supply pressure Connect a gas pressure SUPPLY < 2,7bar (270 kPa) or according to the flow < 100 L/min. specifications. INTERNAL 302 HIGH Pressure in the Contact Technical...
  • Page 132 Alarm Priority Cause Action Range Pre- Vent. defined mode MEMORY 306 MEDIUM Incorrect EEPROM due Contact Technical FAILURE to corrupt data. Service. HARDWARE 307 HIGH Internal bus comm. Contact Technical FAILURE failure. Service. DEPLETED 308 HIGH Battery voltage below Charge the battery (if BATTERY the alarm threshold.

  • Page 133: Co2 Analyzer (Irma) Technical Alarms

    10.3.2. CO2 analyzer (IRMA) technical alarms Alarm Priority Cause Action Range Pre- Vent. defined mode 310 HIGH CO2 sensor Plug the sensor to the DIS- disconnected DB9 connector CONNECTED 311 LOW CO2 measurement Restart the CO2 OUT OF outside the specified analyzer.
  • Page 134 Alarm Priority Cause Action Range Pre- Vent. defined mode 314 LOW Lost factory Restart the CO2 FAB. calibration in the CO2 analyzer. Change the CALIBRATION analyzer, correct CO2 analyzer. Contact LOST measurement not Technical Service. guaranteed. 315 LOW CO2 analyzer IR signal Replace the CO2 ADAPTER low (damage in the...
  • Page 135 Alarm Priority Cause Action Range Pre- Vent. defined mode 317 LOW CO2 analyzer Operate in correct TEMP. temperature out of ambient condition. OUT OF safety range Restart the CO2 RANGE (10-40ºC). analyzer. Change the CO2 analyzer. Contact Technical Service. 318 LOW CO2 analyzer pressure Operate in correct AMBIENT...

  • Page 136: Other Faults

    Do not activate the NIV (option in the buttons bar) in patients with invasive WARNING interface (intubated airway). If the cause of alarm or fault isn’t solved, the ventilator may not function NOTE properly. In this case contact with Hersill or its authorized Distributor.

  • Page 137: Configuration

    11. Configuration By pushing the key [CONFIGURATION] in the touchpad, it is accessed the Configuration interface from any ventilation screen, without interrupting the patient ventilation. The scope of the configuration (the accessible options) depends on the access level entered. This User Manual deals exclusively with the configuration for the access levels USER and INSTALLER.
  • Page 138 • ΔP: (the changes in the PEEP setting can vary the Pinsp or PS setting automatically) o Off: Pinsp, PEEP and PS are controlled independently. o On ↑↓: When increasing or decreasing PEEP, then Pinsp / PS increases or decreases. o On ↑: When increasing PEEP, Pinsp / PS increases (but decreasing PEEP they don’t).
  • Page 139 • Bat 75-25: Time for the battery autonomy test calculation to generate the alarm REPLACE BATTERY (ID 309). Range: 0-180 minutes (0 = disabled). Default value: 25 minutes. • Execution mode (only available in Installer access level): Normal / Demo. .

  • Page 140: Interface

    12. Interface By pushing the key [INTERFACE] in the touchpad, the lower buttons bar changes to allow to configurate the interface of the ventilation screen (without interrupting the patient ventilation).
  • Page 141 • Data 1: To choose the parameter shown in the right side of the screen below the two fixed parameters (P and V ). See the chapter 6.4.2.3 for deep information. • Data 2: To choose the parameter shown in the right side of the screen below [Data 1]. See the chapter 6.4.2.3 for deep information.

  • Page 142: Communications

    13. Communications The ventilator VITAE 40 includes wireless communication capabilities in Bluetooth and Wi-Fi networks. Its purpose is to allow data transmission from the ventilator according to the requirements of ISO 80601-2-84: to an electronic health record and to an alarms control system.
  • Page 143 The Bluetooth module of Vitae 40 complies with Part 15 - Spread Spectrum NOTE Transmitter and with Digital Transmission System of the FCC regulation, in the terms of that Vitae 40 will not cause any harmful interference and it will not suffer damage when receiving interference. FCC identifier: A8TBM78ABCDEFGH.

  • Page 144: Maintenance

    14. Maintenance Cleaning, disinfection and sterilization procedures 14.1. Any deviation from the recommended method is the responsibility of the user. Definitions: 1. Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and it is usually accomplished manually or mechanically using water with detergents or enzymatic products.
  • Page 145 The ventilator and its parts must be cleaned, disinfected or sterilized before NOTE starting any maintenance procedures and after a repair To obtain additional information on infection control procedures, please, NOTE contact HERSILL or your dealer. HERSILL telephone +34 916 166 000...

  • Page 146: Cleaning Procedure

    14.1.1. Cleaning procedure For the accessible parts and surface materials, Hersill recommends manual cleaning: 1. With a disposable cloth, dipped in warm water with an allowed detergent*, clean the surfaces. 2. With a disposable cloth, dipped in clear warm water without detergent, remove residues of detergents (residues of detergents reduce the lifetime of the plastic materials).

  • Page 147: Sterilization Procedure

    14.1.3. Sterilization procedure Previously manually cleaned or in a washing machine, as described. Hersill recommends using Steam sterilization in gravity autoclave. the autoclavable parts in VITAE40 are allowed for two sterilization procedures: a. 121 ºC 1,3 k/cm , for 25 minutes; drying time 30 minutes.

  • Page 148: Preventive Maintenance - Intervals

    The General review must be performed by the official technical service WARNING authorized by HERSILL. A replacement of the battery and the filter (fresh air intake filter) must be performed every 1 year or 3 months of operation, the first thing that happens.
  • Page 149 NOTE disposed separately in conformity with the local waste disposal laws and regulations. Hersill provides a software support of 5 years from the manufacturing date. NOTE The cleaning intervals depend on the use and correct installation of the filters. NOTE The following table is intended as a basic guide: acute instructions of the hospital's hygiene officer shall prevail.
  • Page 150 Frequency Procedure Chapter Ventilation test: Checklist + Autotest Each patient Cleaning- Disinfection-Sterilization of the Reusable circuit 14.2.2 Replacement of the Disposable circuit 14.2.2 Daily Cleaning of accessible parts and ventilator surface 14.2.1 Cleaning of the mains electric cord 14.2.3.3 3 months Cleaning of the gas supply hose 14.2.3.4 1 year /...

  • Page 151: Accessible Parts And Ventilator Surface

    14.2.1. Accessible parts and ventilator surface Accessible parts and the surface of the materials must be cleaned after each use or at least once a day. 14.2.2. Patient circuit maintenance The procedure varies depending on whether it is a disposable or a reusable patient circuit. 14.2.2.1.
  • Page 152 Disassemble the patient valve in 4 pieces (see the figure below, the umbrella valve can be replaced easily by using a tweezers). Remove the Flow-P sensor and its tubing. Sterilize / disinfect these parts according to the procedures (see chapter 14.1). Re-assemble the patient circuit (see chapter 5.3).

  • Page 153: Parts Subject To Maintenance

    Configuration - Tools (see how to access this button in chapter 11). The only battery compatible with the ventilator is the pack supplied with the CAUTION unit and/or supplied by HERSILL (see reference in chapter 15). The old battery must be treated as special waste in accordance with the local NOTE regulations.

  • Page 154: Fresh Air Intake Filter Replacement

    14.2.3.2. Fresh air intake filter replacement The fresh air intake filter is a specific particle filter (see reference in Chapter 15) placed in the ambient air intake (see Connections in Chapter 4.1.). It is accessible by using an Allen key n.6. This part is in charge to filter the air to be inhaled by the patient when FiO2 is below 100%, therefore it is essential to always keep it in an optimal state.
  • Page 155 3. Place the new filter (see reference in Chapter 15), with tweezers, perfectly centered, being very careful not to press on the silicone valve (modifying something in the valve can cause leakage during operation) (see Fig.3 and Fig.4). 4. Place (screw firmly but not too much) the Gas inlet cover by using an Allen key n.6 (see Fig.1). Don’t touch the silicone valve! Fig.1...

  • Page 156: Mains Electric Cords Maintenance

    14.2.3.3. Mains electric cords maintenance The DC cables must be cleaned pursuant the procedure described in chapter 14.1.1. In addition, every 5 years all the supply cords should be replaced (see references in chapter 15). 14.2.3.4. Gas supply hoses maintenance The low pressure O2 supply hoses must be cleaned pursuant the procedure described in chapter 14.1.1.
  • Page 157 a) Unplug the DC supply cable. b) Take out the battery (see chapter 14.2.3.1 ). c) Reset the unit: Push the on/off button in the keyboard during 10 seconds. d) Install new charged battery (see the caution and note below). e) Plug the DC supply cable.

  • Page 158: References (Options, Accessories, Consumables And Spares)

    15. References (options, accessories, consumables and spares) 1. Minimum requirements: 1.1. VITAE 40: Ref. 5200800 INCLUDING: Standard ventilation modes: VCV, VCV-ACV, VC-SIMV, PCV, PCV-ACV, PC-SIMV, Manual. CPR modes (complete CPR assistants and CPV ventilation), O2 flowmeter. Patient circuit Vitae40 disposable adult (ref. 4200892), Ambulance supply cable (ref. 3200885), battery pack NiMH rechargeable (ref.
  • Page 159 2. Options: 2.1. Advanced ventilation modes (PSV + APVG): Ref. 4200803 Including: APVG (Adaptive Pressure Volume Guaranteed), PSV (Pressure support) + VC-SIMV-PS, PC-SIMV-PS, APVG-SIMV-PS 2.2. Capnography (CO2 analyzer main-stream): Ref. 4200802 Including: IRMA CO2, Airway adapter and CO2 graphic monitoring 2.2.1.
  • Page 160 3.2. Transport case for cylinder 2/3 L Ref. 4200996 3.3. Transport case for Vitae 40 + Cylinder 2/3L + Accessories Ref. 4200990 3.4. Cart for Vitae 40 + Cylinder up to 7L + AC/DC + Accessories Ref. 4200860 3.5. Wall bracket XG Ref. 4320301 3.6.
  • Page 161 3.14.5. Tube double for Flow-P sensor 1,8m - reusable (silicone) Ref. 3200897 3.14.6. Tubing hanger Ref. 0100010 (x3) 3.14.7. Filter bacterial-virus-moisture (HME) for adult – single use Ref. 0100009 3.14.8. Filter bacterial-virus-moisture (HME) for pediatric– single use Ref. 0100012 3.15. Kit O2 flow and Capno (kit for oxygen-therapy and optional capnography) Ref.
  • Page 162 Ref. 0100012 4.5. Airway adapter for IRMA CO2 - adult/pediatric Ref. 0100101 4.6. Airway adapter for IRMA CO2 - infant Ref. 0100102 4.7. Filter VITAE 40 ventilator air intake Ref. 3200817 5. Spares: 5.1. Ambulance supply cable Ref. 3200885 5.2. Battery pack rechargeable NiMH...

  • Page 163: Technical Specifications

    16. Technical specifications Ventilation modes See chapter 3.2 (main features) and chapter 7 (Ventilation modes). Ventilation settings Ventilation settings expressed in BTPS conditions (body temperature and pressure saturated) • Tidal volume (VT) 5 to 3000 mL (50 to 1500 mL in Volume modes) •...
  • Page 164 Patient breathing circuit or Ventilator breathing system (VBS) • VBS Resistance: Adult VBS Pediatric VBS 60 L/min 30 L/min 30 L/min 15 L/min 3 L/min Inspiratory resistance 2,8 mbar 1,5 mbar 5,4 mbar 1,7 mbar 0,7 mbar Expiratory resistance 2,9 mbar 1,5 mbar 5,6 mbar 1,8 mbar...
  • Page 165 Accuracy VTe / VTi PEEP VT ≥ 300 mL ± 15 % of the reading ± 2 mbar ± 2 mbar 300 mL ≥ VT ≥ 50 mL ± 20 % of the reading VT < 50 mL ± 15 mL + 25% of the reading According to the standard ISO 80601-2-84:2018 (Particular requirements for basic safety and essential performance of emergency and transport ventilators): All the units shall be expressed at STPD, except for those associated with the VBS (Ventilation Breathing System) which shall be expressed at BTPS.
  • Page 166 Scientific basics considered by the standards for measurement indications used in patient ventilation: In the ventilation, the gas in the lungs has an identical temperature to body temperature (approximately 37°C) regardless gas temperature administered for ventilator (while 0°C normal temperature is used as in physics, engineering often used either 20 or 21,2°C).
  • Page 167 Maximum inspiratory flow • 120 L/min (60 L/min for 100 %O * Attainable oxygen concentration vs. patient counterpressure:...
  • Page 168 Monitoring • Graph (configurable): o Ventilation curves: Pressure/time, Flow/time, Volume/time, CO2/time. o Ventilation trends: PIP, VMe, Cdyn, EtCO2. o Ventilation loops: Volume/Flow (V-F), Pressure/Volume (P-V), Flow/Pressure (F-P). o Volumetric capnography: VCO2 (SBCO2), V’CO2 trend, V’alv trend. • Parameters (2 fixed and 2 configurables *): Fixed: Peak inspiratory airway pressure (PIP) 0 to 100 mbar...
  • Page 169 Alarms (audible and visual) For deep information regarding to alarms see chapter 10. alarm alarm APNEA GAS SUPPLY LOW PAW HIGH INTERNAL GAS REGULATION FAILURE PAW MAXIMUM BATTERY IN USE PAW NOT REACHED BATTERY LOW VT HIGH BATTERY FAILURE VT LOW MEMORY FAILURE VTE NOT REACHED HARDWARE FAILURE...

  • Page 170: Ambient Conditions

    570 to 1200 hPa • Height above the sea level: Up to 4000 m height VITAE 40 includes an internal pressure and temperature sensor to compensate the altitude and temperature, keeping the accuracy of flow, pressure and volume during ventilation. Electric power supply •...

  • Page 171: Communications (Optional)

    Gas supply • Medical O 2,7 to 6,9 bar (270 to 690 kPa ; 39 to 100 psi) (see warning below) • Inlet connection: O DISS (available double inlet distributor and other standardsadaptors). o Gas consumption for internal control: Max. 0,1 L/min. According to ISO 80601-2-84: WARNING - The ventilator is a high-flow device and should only be connected to a...

  • Page 172: Protection Devices

    • VITAE 40: 227 x 125 x 65 mm • AC/DC adapter (optional): 107 x 47 x 30 mm Weight • VITAE 40 (with battery): 1400 g • AC/DC adapter: 280 g Protection devices • Maximum limited patient pressure device: 105 hPa (105 cmH2O) •...

  • Page 173: Enclosure Protection

    Enclosure protection IP44 (protected against dust and particles and water splashing from all directions). Mechanical strength, including XG support Compliance for mechanical vibrations and impact at 30g ; for helicopters, fixed wing aircraft and ambulances, according to standards: IEC 60601-1, IEC 60601-1-12, ISO 10651-3, EN 794-3, EN 1789, EN 13718-1, EUROCAE ED-14G and RTCA DO-160G.

  • Page 175: Emc Declarations

    RADIATED RF DISTURBANCES ARE CONTROLLED. THE CUSTOMER OR THE USER OF THE VENTILATOR CAN HELP PREVENT ELECTROMAGNETIC INTERFERENCE BY MAINTAINING A MINIMUM DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT (TRANSMITTERS) AND THE VITAE 40 AS RECOMMENDED IN TABLE 205, ACCORDING TO THE MAXIMUM OUTPUT POWER OF THE COMMUNICATIONS EQUIPMENT.
  • Page 176 Guidance and manufacturer's declaration - Electromagnetic Emissions Emissions Tests Compliance Electromagnetic Environment - Guidance The VITAE 40 ventilator uses RF energy only for its internal function. RF emissions Group 1 Therefore, its RF emissions are very low and are not likely to cause CISPR 11 any interference in nearby electronic equipment.
  • Page 177 40 % U (60 % dip 40 % U (60 % dip interruptions and voltage If the user of the VITAE 40 ventilator in U for 5 cycles) in U for 5 cycles) variations power supply...
  • Page 178 Guidance and manufacturer's declaration – Electromagnetic immunity for life support equipment Test Maximum Inmunity Band Service Modulation Distance Frequency power Test Level (MHz) (MHz) (V/m) Pulse modulation 380 - 390 TETRA 400 18 Hz GMRS 460, 430 - 470 +- 5 kHz deviation FRS 460 1 kHz sine Pulse modulation...
  • Page 179 Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the VITAE 40 ventilator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
  • Page 180 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m) 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...
  • Page 181 Recommended separation distances between portable and mobile RF communications equipment and the life support equipment. The VITAE40 is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the Product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Product as recommended below, according to the maximum output power of the communications equipment.
  • Page 182 Guidance and manufacturer’s declaration electromagnetic emissions (RTCA/DO-160G) Description Standard Criteria RTCA/DO-160G Radiated emission of radio frequency energy Category M Section 21 RTCA/DO-160G Conducted emission of radio frequency energy Category M Section 21 Guidance and manufacturer’s declaration electromagnetic immunity (RTCA/DO-160G) Description Standard Criteria Test level:...
  • Page 184 © VITAE is a registered trademark This manual is only valid for the equipment with serial number: Hersill reserves the right to modify its equipment and user guides without notice...
  • Page 186 HERSILL, S.L. Puerto de Navacerrada, 3 - 28935 Móstoles, Madrid, SPAIN Tel.: +34 916166000 www.hersill.com...

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