VENTINOVA MEDICAL Evone Instructions For Use Manual Download Page 60

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Instructions for Use Evone

Appendix

Appendix I - Guide to Symbols

Symbol

Description

Consult Instructions for Use

CE marking

Indicates separate collection for electrical and electronic equipment (WEEE)

Model / article number

Serial number

Enclosure protects against fingers or similar objects and
not protected against contact with water

Medical Device

Manufacturer

Does not contain natural rubber latex

Do not use if packaging is damaged

Fuse that is used within the product

Stand-by button

Release of Evone cartridge

Sign indicating warning/caution which needs to be taken into account

Type BF applied part

Audio Paused / Mute

Evone operates on mains power, battery charging

Summary of Contents for Evone

Page 1: ...EN Instructions for use Evone ...

Page 2: ...E info ventinova nl Copyright 2021 Eindhoven the Netherlands Disclosure to third parties reproduction or publication of this documentation or any part thereof or the use of any information contained therein for purposes other than provided for by this document is prohibited without the prior and express written permission of Ventinova Medical B V All information is subject to change Figures and ph...

Page 3: ... 10 2 1 Evone Control Unit 10 2 2 Evone Breathing System 13 2 3 Accessories 15 2 3 1 Tritube 15 2 3 2 Conventional adult endotracheal tube 15 2 3 3 Trolley 16 2 4 Distributed Information System 16 3 Ventilation Principle 17 3 1 FCV Mode 17 3 2 Jet Mode 19 4 Preparation 21 4 1 System Assembly 21 4 2 Connecting Evone 23 4 2 1 Medical Gases 23 4 2 2 Electrical Power 23 4 2 3 Mainstream CO2 Sensor 23 ...

Page 4: ... Special Functions 42 6 5 1 Ventilation Pause 42 6 5 2 Safety State 42 6 5 3 Negative End Expiratory Pressure 42 6 5 4 Inspiration Hold 43 6 6 Shut Down 43 7 Cleaning and Disposal 44 7 1 Switching Between Patients 44 7 2 General Cleaning Instructions 44 7 3 Cleaning of the Control Unit 44 7 4 Cleaning of the CO2 Sensor 45 7 5 Reprocessing of the Airway Adapter 45 8 User Maintenance and Service 46 ...

Page 5: ... of contents 5 9 Alarms 48 10 Technical Specifications 54 10 1 Evone Parameters 54 10 2 Evone Control Unit Pneumatic Scheme 57 10 3 Safety Philosophy 58 Appendix I Guide to Symbols 60 Appendix II Glossary 61 ...

Page 6: ...r jet ventilation modes Evone is intended to be used in elective procedures for less than 72 hours without the need to use inhaled anesthetic agents 1 3 Operator Evone is intended to be used by or under direct and undivided supervision of an anesthesiologist or intensivist in all settings For safe and effective use of the device device specific training is required 1 4 Patient Group All patients 4...

Page 7: ...ore details see 6 5 3 1 7 Generic warnings Warnings Before using Evone make sure an alternative ventilation method is available for the specific patient When using Tritube the advised alternative is the use of Ventrain Other alternatives may include balloon ventilation through a laryngeal mask or a conventional tube preferably inserted parallel to Tritube When using conventional tubes in combinati...

Page 8: ... shock this equipment must only be connected to a supply mains with protective earth To set alarm limits towards extreme values may render the alarm system useless Do not obstruct exhaust openings on the back side of Evone The operator shall not touch serial port or CO2 sensor port simultaneously with the patient Table 1 1 List of applicable warnings 1 8 Generic cautions Cautions The emissions cha...

Page 9: ...pared to best clinical practice pressure controlled ventilation a prospective randomized porcine study Crit Care 24 662 2020 4 Schmidt J et al Flow Controlled Ventilation Attenuates Lung Injury in a Porcine Model of Acute Respiratory Distress Syndrome A Preclinical Randomized Controlled Study Crit Care Med 48 e241 e248 2020 5 Weber J et al Flow controlled ventilation FCV improves regional ventilat...

Page 10: ...quired additional materials Tritube Ventinova Medical B V or conventional adult cuffed endotracheal tube single lumen at least 5 mm ID and double lumen tube at least CH35 Artificial lung Warning Do not use Evone on non invasive ventilation accessories 2 1 Evone Control Unit The Evone Control Unit is shown in Figure 2 1 from four different sides Detachable parts are presented in Figure 2 2 The numb...

Page 11: ...System description 11 2 15 16 17 18 Figure 2 2 The detachable parts of Evone Control Unit ...

Page 12: ...ng system in place during use 7 Release button to release breathing system from control unit 8 CO2 sensor cable holder 9 High pressure medical oxygen inlet 10 High pressure medical air inlet 11 Serial data port to transfer real time data 12 CO2 sensor port 13 Power cable connector 14 Stand by button 15 Mainstream CO2 sensor connecting cable 16 Power Cable 17 High pressure oxygen tubing 18 High pre...

Page 13: ...n two configurations which either include the Evone Breathing Tubing or the Evone Conventional Tube Adapter All parts are shown below Additionally an artificial lung not shown is required to perform startup checks Preferably the artificial lung has a volume of 1 L and a compliance of 25 mL cmH2 O Materials are further explained in Table 2 2 Figure 2 3 Evone Breathing System A E ...

Page 14: ...ht Teleflex single use D Evone Conventional Tube Adapter Ventinova Medical B V single use D1 15 mm OD connector for connection to HMEF D2 15 mm OD connector for connection to conventional adult endotracheal tube D3 Pressure lumen connector for connection to the pressure lumen of the Evone Cartridge D4 Pressure lumen for intratracheal pressure measurements to be inserted in the conventional adult e...

Page 15: ...g Tubing Figure 2 4 Tritube 2 3 2 Conventional adult endotracheal tube Conventional adult endotracheal tube single lumen at least 5 mm ID and double lumen tube at least CH35 with an ID of at least 5 mm can be used with Evone in combination with the Evone Conventional Tube Adapter Figure 2 5 Conventional adult endotracheal tube ...

Page 16: ...ta output format see also section 6 1 Be aware that exported information shall not be used in a distributed alarm system as the device needs undivided attention of the user Contact Ventinova Medical B V for information on the data protocol Exported data Clinical event data FCV mode data JET mode data Alarm data Settings and alarm data Ventilation Settings Alarm settings Alarm status Connection A s...

Page 17: ... is traditional High Frequency Jet Ventilation for example to gently liberate a patient from post operative mechanical ventilation to spontaneous breathing To be used with Tritube with deflated cuff Both methods are described in more detail in 3 1 and 3 2 3 1 FCV Mode The FCV Mode applying FCV ventilation is used for full ventilation while controlling the flow in the whole ventilation cycle FCV ve...

Page 18: ...n gasses flow either into or out of the lungs Therefore only the set flow and I E ratio determine a patients minute volume Set Peak and EEP determine the inspiratory volume Ventilation frequency is a result of parameter settings and does not affect minute volume In FCV Mode expiration is actively supported by Evone resulting in a controlled decline in intratracheal pressure A negative end expirato...

Page 19: ... conventional endotracheal tubes with the cuff of Tritube fully deflated to enable expiratory gases to freely egress Warning The cuff must be deflated by hand before Jet Mode can be started Risk on barotrauma Warning The cuff must be checked for accumulated debris before deflation Risk on infection Warning Do not use the Jet Mode in combination with the Evone Conventional Tube Adapter Risk of baro...

Page 20: ...ure is controlled by a set frequency and inspiration percentage During inspiration Intratracheal pressure is expected to stay below the configured Peak Inspiratory Pressure PIP alarm limit During expiration which is passive the intratracheal pressure is expected to decrease below the operator configured Pause Pressure PP alarm limit if not the operator is notified by an alarm and the ventilation c...

Page 21: ...to the Control Unit Figure 4 1 Figure 4 1 Cartridge placement steps Upon placement of the Evone Cartridge assemble the Evone Breathing System in combination with either Tritube see Figure 4 2 or a conventional adult endotracheal tube see Figure 4 3 Figure 4 2 Assembly order of Evone Airway Adapter HME filter Evone Breathing Tubing and additional part Tritube Parts are explained in Table 1 2 D2 D1 ...

Page 22: ...ing Always install an HME Filter between the Evone Airway Adapter and Breathing Tubing Conventional Tube Adapter Risk on contamination of the Control Unit Warning Make sure parts are connected tightly Risk on leakage or disconnection of breathing system during ventilation Warning Inspect the Airway Adapter for damage prior to use Do NOT use the Airway Adapter if it appears to be dirty damaged or b...

Page 23: ...nts and insufficient ventilation 4 2 2 Electrical Power Connect Evone to a mains power supply of between 115 and 230 Volt AC using the power cable component 16 Warning Always use a protective earthed socket for the mains power plug of Evone Warning Whenever possible connect the device to the mains power supply since the battery lifetime of Evone is limited The expected battery operating time is 1 ...

Page 24: ...1 Self Check Immediately after switching on Evone a Self Check will start while showing the screen of Figure 5 1 During the Self Check basic proper functioning of the valves sensors alarm controller signals and internal communication are checked Figure 5 1 Self Check screen After performing the Self Check successfully Evone will automatically continue to the Startup Check section 5 1 2 A failing S...

Page 25: ...disconnect and reconnect gas supplies and Evone accessories In the Startup Check screen the actual values for the oxygen and air gas supply pressures are displayed The Startup Check involves three tests which cover the following test items Alarm Indication Alarm sound and light signals are generated User needs to confirm low medium and high priority alarm signals when indicated FCV Mode User needs...

Page 26: ...ually to test specific alarms First choose random patient settings and start ventilation in FCV mode with the artificial lung before gene rating the following alarms High Pressure Alarm Hit lung at end of inspiration Disconnection Alarm Leakage respiratory circuit alarm Disconnect the Evone airway adapter from the Evone Cartridge Obstruction Alarm Kink the Evone Breathing Tubing Kink the ventilati...

Page 27: ... a color change Furthermore the patient s length weight and age can be chosen by the sliders on the right hand side of the screen I e the age can be set between 10 and 100 years and weight can be set between 40 and 150 kg Pop up screens Figure 5 5 appear to set the date of birth right top corner The age at actual date will adjust automatically to match the date of birth not vice versa The values c...

Page 28: ...flow 5 3 1 Ventilation with Tritube 1 Induce total intravenous anesthesia TIVA 2 Intubate patient with Tritube according to manufacturer s instructions 3 Connect Tritube to Evone ventilation lumen and pressure lumen 4 Optional start ventilation with the cuff deflated to allow deepening of anesthesia Jet mode Note that the airway is open risk on aspiration 5 Start ventilation with the cuff inflated...

Page 29: ...Flow to adjust Minute Volume Note that spontaneous breathing is not possible when the CTA is connected to the conventional adult endotracheal tube 5 3 3 Handling obstructions 1 Stop ventilation 2 Fiercely flush the pressure lumen and or ventilation lumen with 2 5 mL saline followed by 15 mL air 3 In case secretions are still present in ventilation lumen remove secretions using a suction catheter N...

Page 30: ... is optimized 5 3 5 Weaning the patient 1 Set FiO2 as preferred Tritube Wake patient using one of the two ventilation options 2 With inflated cuff e g in case of aspiration risk in FCV mode 3 Gently wake patient no shaking Deflate cuff and extubate when patient awakes Or 2 With deflated cuff in Jet mode risk on aspiration 3 Open airway required 4 Adapt settings if required e g lower driving pressu...

Page 31: ... the dynamic intratracheal pressure EEP is lower than the static and mean global alveolar pressure The absolute discrepancy in pressure between the dynamic intratracheal pressures and static and mean global alveolar increases with higher airway resistance and or higher inspiratory and expiratory flow It is recommended to confirm proper ventilation pressure settings by judging the plateau pressure ...

Page 32: ...the User Interface Language the date and time as displayed on the screen the serial data output format and the current alarm sound level If necessary the Date and Time may be adjusted by tapping the Chan ge button Similarly the preferred User Interface language may be changed into one of the available languages the serial data output format may be changed into one of the available formats and the ...

Page 33: ... zeroing the CO2 sensor make sure of the following Always use a clean and undamaged airway adapter when performing the zeroing process This test will zero the baseline of the CO2 sensor User needs to put CO2 sensor onto the Evone airway adapter and keep both in ambient air when indicated The zeroing process may vary in duration from a few seconds up to 2 minutes depending on sensor temperature A F...

Page 34: ...tings menu 8 Mute Alarm Button to mute the active alarm s 9 Time and Date Showing current time and date 10 Power Supply Status Indicating battery level only showing full battery or low battery level A full battery level always ensures 30 minutes of ventilation When 30 minutes of ventilation cannot be guaranteed the low battery level is indicated A power plug indicates that the device is connected ...

Page 35: ...s 26 Alarm Notifications Alarm notification and alarm history 27 Alarm Bar Appearance of alarm messages 28 CO2 graph Measured CO2 level during the past 30 seconds 29 Intratracheal Pressure graph Measured intratracheal pressure during the past 30 seconds 30 Inspiratory Volume graph Indicates trend of measured inspiratory volume 31 Alarm Limits Graphical representation of the set alarm limits by ora...

Page 36: ...ble 6 2 below the ranges are given for all adjustable ventilation parameters including the step size Parameter Unit Setting Resolution Default Min Rounded Max Rounded Rounded Peak mbar 5 100 1 15 kPa 0 5 10 0 0 1 1 5 cmH2 O 5 102 1 15 EEP mbar 10 30 1 5 kPa 1 0 3 0 0 1 0 5 cmH2 O 10 31 1 5 I E Ratio 1 1 0 1 2 5 0 1E 1 1 0 Inspiration Flow L min 2 20 1 12 FiO2 Percentage 21 100 5 starting from 25 5...

Page 37: ...1500 50 10 mL kg IBW Minimum Inspiratory Volume mL 150 1000 50 4 mL kg IBW Table 6 3 Setting ranges and default values of alarm limits in FCV mode After adjusting ventilation settings of alarm limits changes need to be confirmed FCV is initiated by pushing the start button Evone will start with 1 volume controlled ventilation cycle to confirm equal pressure values while independently measured via ...

Page 38: ... Start Stop Start button to switch between active ventilation and idle state 34 Single Lumen Single lumen jet function Currently inactive will be active in future software upgrades 35 Take CO2 Sample Pushing the button will result in a 2 second inspiration phase at existing settings followed by an active expiration phase of 2 seconds using an expiration flow of approximately 6 L min in order to me...

Page 39: ...asured pause pressure value 44 FiO2 Set inspiratory O2 percentage 45 Driving Pressure Pressure supplied by Evone onto Tritube 46 Frequency Breathing frequency 47 Inspiration Percentage of inspiration time relative to total cycle time 48 Set PIP Alarm Limit Button to change Peak inspiratory pressure alarm limit 49 Set PP Alarm Limit Button to change pause pressure alarm limit 50 Alarm Notifications...

Page 40: ...ring ventilation as indicated in Table 6 6 Parameter Unit Setting Resolution Default Min Rounded Max Rounded Rounded PIP alarm mbar 10 40 1 25 kPa 1 0 4 0 0 1 2 5 cmH2 O 10 41 1 25 PP alarm mbar 5 15 1 10 kPa 0 5 1 5 0 1 1 0 cmH2 O 5 15 1 10 Table 6 6 Setting ranges and default values of alarm limits in Jet Mode Jet ventilation is initiated by pushing the start button 6 4 Alarm Interface Alarm mes...

Page 41: ...and sound The system has detected a situation in which the patient is in immediate danger Take direct actions to minimize the impact on the patient Yellow Medium priority alarm with yellow orange blinking light and sound The system has detected an error that could indicate either a situation with the patient or a problem with the device Check and take appropriate actions Blue Low priority alarm wi...

Page 42: ...e user from using the device any further The issue may be due to an irreversible technical defect or an external situation leading to an immediate potentially hazardous situations for the patient When the safety state becomes active a pop up screen will appear The user has only one option shut down the device If the message occurs during ventilation the user should switch to alternative ventilatio...

Page 43: ...bring the intratracheal pressure to Peak level and keep it there for maximum 60 seconds to be used for clinical recruitment maneuvers The Inspiration Hold button may be accessed from the active FCV ventilation mode Upon clicking a yellow border appears around the button Additionally a timer located below the top left FCV mode indicator will count down from 60 seconds to 0 After this countdown vent...

Page 44: ...pose the HME filter and endotracheal tube after each patient Risk on cross contamination Warning Dispose the Cartridge after each procedure Risk on cross contamination 7 2 General Cleaning Instructions Always dilute cleaning agents according to the manufacturer s instructions for use to the lowest possible concentration Do not immerse any part of the control unit in liquid Do not pour liquid on th...

Page 45: ... if it appears to have been damaged If damaged refer servicing to qualified service personnel 7 5 Reprocessing of the Airway Adapter Treat Evone airway adapter in accordance with your institutional protocol for reusable items Clean by rinsing in a warm soapy solution followed by soaking in either one of the following liquid disinfectants Isopropyl alcohol 70 10 aqueous solution of chlorine bleach ...

Page 46: ...ted by the legal manufacturer Do not open the device Battery condition check and if needed replacement can be done by a specialist who is trained by Ventinova Medical B V Further details on the maintenance and training can be acquired from Ventinova Medical B V 8 3 2 User maintenance When the power cord needs replacement make sure these parts are replaced by identical parts of the same type Furthe...

Page 47: ...rts and additional materials of Evone should be disposed simi lar to general hospital waste Please make sure all local laws are followed 8 7 Software Upgrade When a new software version is available the software of Evone can be upgraded by means of the SD card port located on the left hand side of the device Thereafter an SD card with the software update will become available and the following ste...

Page 48: ...t ventilation performance is reduced Ventilation pause with passive pressure release to EEP Remove obstructions and or kinks between the distal end of the tube and gas outlet High Intratracheal pressure high Intratracheal pressure higher than alarm limit Intratracheal pressure is above the Peak pressure alarm limit Ventilation pause with passive pressure release to EEP until condition ceases Cease...

Page 49: ...er than alarm limit Inspiratory volume does not reach the volume lower alarm limit while Peak pressure is reached Possible causes compression of lungs by external cause unexpected compliance decrease Dual pressure measurements are compared When check succeeds ventilation is continued at first correct cycle Check patient Medium Inspiration volume high inspiration volume higher than alarm limit Insp...

Page 50: ...t when condition ceases Cease delay 2 s Consider to adjust ventilation settings as set I E ratio cannot be reached Medium Leakage detected Leakage detected during first cycle Leak detected during first cycle None Check for leakage in respiratory circuit including cuff Medium Evone Cartridge dislocated wrongly inserted cartridge Wrongly inserted cartridge or wrongly calibrated exhaust valve Ventila...

Page 51: ...e leak proximal from Tritube Ventilation pause with pressure drop to EEP until ventilation is resumed by user Check all connections in respiratory circuit High Pressure mismatch Measured pressures via pressure and ventilation lumen differ too much Ventilation lumen pressure measure ment and pressure lumen measurement differ too much Difference could not be solved by pressure lumen purge or ventila...

Page 52: ...If alarm persists contact manufacturer High Gas supply pressure too high Gas supply pressure 8 bar Supply pressure might damage equipment Gas supply pressure 8 bar Delay 2 s Move to safety state Switch to alternative gas sources Consider to start alternative ventilation High Battery low Battery level assures maximal 30 minutes of ventilation Battery level not sufficient for more than 30 minutes of...

Page 53: ...ent air pres sure 2 7 bar Delay 20 s Alarm is reset when condition ceases Check air supply Low O2 supply pressure low O2 supply pressure 2 7 bar Insufficient O2 pressure 2 7 bar Delay 20 s Alarm is reset when condition ceases Check O2 supply Low Self check failed Self check failed on critical function Failed self check on critical function No ventilation before problem has been solved Restart Evon...

Page 54: ...ncy 50 60 Hz Protection Class Control Unit Class I Applied Parts CO2 Sensor Breathing tubing cartridge Type BF Power 120 VA Minimum ventilation time on full battery 1 Hrs Fuse T2AH 250V Standard Emissions class group or Immunity test level CISPR 11 Class A Group 1 EN 61000 3 2 Class A EN 61000 3 3 PASS IEC 61000 4 2 15 kV air 2 kV 4 kV 6 kV 8 kV contact and air IEC 61000 4 3 1 Radiated RF EM field...

Page 55: ... line to ground 2 kV IEC 61000 4 6 3 Vrms 0 15 MHz 80 MHz 6 Vrms in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz EN 61000 4 8 30 A m IEC 61000 4 11 0 UT 1 cycle 70 UT 25 cycles 5 UT 250 cycles At 0 45 90 135 180 225 270 and 315 Gas Supply Parameters Gas Supply Pressure 3 0 6 0 10 bar Gas Supply Flow 20 L min Gas Supply Types Medical grade oxygen and medical grade compressed air Ventilation...

Page 56: ...non condensing RH Storage Relative Humidity 10 95 non condensing RH Temperature 15 40 C Barometric Pressure 500 1060 HPa Stacking Do not stack CO2 Measurement Specifications Principle of Operation Non dispersive infrared single beam optics dual wavelength no moving parts Initialization Time Less than 10 seconds at an ambient temperature of 25 Celsius full specifications within 1 minute CO2 Measure...

Page 57: ...e Control Unit Pneumatic Scheme Figure 10 1 Pneumatic diagram of Evone Figure 10 1 identifies various components of which the details are explained in the table 10 2 Component Purpose Range Input Pressure Sensor Oxygen Port Verify gas input pressure 0 10 bar Input Pressure Sensor Air Port Verify gas input pressure 0 10 bar MFC Oxygen Mix the right amount of oxygen 0 100 l min MFC Air Mix the right...

Page 58: ...sensor readings are compared at regular intervals i e 10 breaths for FCV Mode and each pulse for Jet Mode To enable optimal direct comparison the ventilation is shortly paused at these intervals creating a no flow situation through the ventilation part B If other measurements timing flow indicate a potentially incorrect continuous pressure measurement via the pressure lumen the device pauses venti...

Page 59: ... the set volume limits the device pauses ventilation and compares the pressure reading of the pressure lumen with a measurement via the ventilation lumen as explained above 3 The device is constructed in such a way that the device can stop the gas flow from and to the patient in all conditions including technical fault conditions This is called the Safety State 4 The initial cycle of the FCV Mode ...

Page 60: ...er Enclosure protects against fingers or similar objects and not protected against contact with water Medical Device Manufacturer Does not contain natural rubber latex Do not use if packaging is damaged Fuse that is used within the product Stand by button Release of Evone cartridge Sign indicating warning caution which needs to be taken into account Type BF applied part Audio Paused Mute Evone ope...

Page 61: ...ry conditions BTPD Body Temperature Pressure and Dry conditions BPM Breaths Per Minute ET Endotracheal EtCO2 End tidal CO2 value EEP End Expiration Pressure FCV Name of ventilation method based on controlling both inspiratory and expiratory flow FiO2 Percentage of O2 within the gas mixture HMEF Heat Moisture Exchanger with Filter HME Heat Moisture Exchanger I E Ratio Inspiration to Expiration Rati...

Page 62: ... 2021 Ventinova Medical B V Ventinova Medical B V Meerenakkerplein 7 T 31 0 40 7516020 E info ventinova nl 5652 BJ Eindhoven The Netherlands www ventinovamedical com ...

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