VENTINOVA MEDICAL Evone User manual

EN Instructions for use Evone

CAUTION:
Federal law (USA) restricts this device to sale by
or on the order of a licensed practitioner.
Device Information
Name: Evone
Document Information
Instructions for Use
Version: MSS076.10
Language: English
Date of issue: January 2021
Manufacturer Information
Ventinova Medical B.V.
Meerenakkerplein 7
5652 BJ Eindhoven
The Netherlands
T+31 (0)40 7516020
E[email protected]
© 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 photos may differ from the
actual situation. Ventinova, Evone, Tritube, Ventrain and FCV are registered trademarks of
Ventinova Medical B.V. All rights reserved.

Table of contents
3
Table of contents
1 Safety 6
1.1 Introduction 6
1.2 Intended Use 6
1.3 Operator 6
1.4 Patient Group 6
1.5 Use Environment 6
1.6 BenetsandComplications 7
1.6.1PotentialBenets 7
1.6.2 Potential Complications 7
1.7 Generic warnings 7
1.8 Generic cautions 8
1.9 References 9
2 System description 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 CO2Sensor 23
5 Operation 24
5.1 Switching On and Starting Up 24
5.1.1 Self-Check 24
5.1.2 Startup Check 25
5.1.3 Additional Checks 26

4
5.2 Setting New Ventilation Parameters 27
5.2.1 Patient Setup 27
5.3 ClinicalWorkow 28
5.3.1 Ventilation with Tritube 28
5.3.2 Ventilation with conventional tubes 29
5.3.3 Handling obstructions 29
5.3.4 Sedation and relaxation 30
5.3.5 Weaning the patient 30
5.3.6 Dynamic and static pressures 31
6 Conguration 32
6.1 Device settings 32
6.2 FCV®Mode User Interface 33
6.3 Jet Mode User Interface 38
6.4 Alarm Interface 40
6.5 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 CO2Sensor 45
7.5 Reprocessing of the Airway Adapter 45
8 User Maintenance and Service 46
8.1 Battery Charging 46
8.2 Storage 46
8.3 Maintenance 46
8.3.1 Yearly maintenance 46
8.3.2 User maintenance 46
8.4 Warranty and Support 46
8.5 Disposal of the Control Unit 47
8.6 Disposal of the accessories 47
8.7 Software Upgrade 47

Table of contents
5
9 Alarms 48
10 TechnicalSpecications 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

Instructions for Use Evone
6
1 Safety
1.1 Introduction
Thank you for choosing Evone. This Instruction for Use accompanies Evone and is intended for
users who operate Evone. Users must be trained.
Always read the Instructions for Use before use!
Refer to the website https://www.ventinovamedical.com/products/evone for further
information and training materials related to this product.
Ventinova Medical B.V. makes no claim for use of the product other than the intended use
speciedhereinanddisclaimsanyliabilityresultingfromotheruses.Observeallwarnings,
cautions and notes.
1.2 Intended Use
Evone is a mechanical ventilator intended to be used for ventilation of patients requiring FCV®
or 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specictrainingisrequired.
1.4 Patient Group
All patients >40 kg IBW
Warning: The body weight limit is based on ideal body weight. Do not use Evone with
obese children with a body weight of less than 60 kg. Risk on barotrauma.
1.5 Use Environment
Evone is intended to be used in operating rooms and ICU environments in hospitals.
Warning: Correct functioning of Evone may be adversely affected by the operation
of other equipment, such as high frequency electro-surgery equipment, short-wave
 therapyequipment,debrillators,orMRIequipment.Riskonmalfunction.

Safety
7
1
Warning: Make sure Evone is not used in an oxygen enriched environment.
 Riskonreorexplosion.
1.6 BenetsandComplications
1.6.1PotentialBenets
Thefollowingbenetsascomparedtovolumecontrolledventilation(VCV)andpressure
controlled ventilation (PCV) may be expected while ventilating patients in FCV®mode:
• Improved lung recruitment and less atelectasis 1–4
• Better aeration of the lungs 1–5
• Higherventilationefciency(oxygenationandCO2removal) 2–4,6
• Lower energy dissipation in the lungs 3,7,8
1.6.2 Potential Complications
(Long term) use of tubes can result in mucosal damage due to cuff and tube contact.
• Long term use of Evone may result in mucosal damage due to dry air.
 AlwaysuseanHMElter.
• Prolonged mechanical ventilation carries the risk of metabolic disturbances.
• Large negative intratracheal end expiratory pressures may result in harm to the patient.
Prevent when possible. Negative End Expiratory Pressure (NEEP) may only be applied in
situations of hemorrhagic shock (for more details see 6.5.3).
1.7 Genericwarnings
Warnings
BeforeusingEvone,makesureanalternativeventilationmethodisavailableforthespecic
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 combination
with the Evone conventional tube adapter, switch to the preferred conventional ventilation
method (e.g. balloon).
ReadalltheInstructionsforUse(ifavailable)ofusedaccessoriesbeforerstuseofthedevice.
OnlyuseaccessoriesspeciedwithinthisInstructionsforUse.Useofaccessories,
transducersandcablesotherthanthosespeciedinthismanualcouldresultindecreased
performance, increased electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of Evone,
includingcablesspeciedinthismanual.Otherwise,itcouldresultindegradationofthe
performance of this equipment.

Instructions for Use Evone
8
Use of Evone close to other equipment, stacked with other equipment or covered with other
materials should be avoided because it could result in improper operation. If such use is
necessary, all equipment should be observed to verify normal operation.
DonotuseEvoneincombinationwithhumidiersornebulizers.Thiscreatesariskon
blockedltersandinsufcientventilation.
Before using Evone, make sure prescribed maintenance (section 8) has been performed.
Otherwise, there is a risk on malfunction or no ventilation.
Evonemaynotbemodied,(partly)dissembledoropenedatanytime.Thiscreatesarisk
on malfunction.
Regularly check EtCO2while ventilating with low inspiratory volumes. Rebreathing can occur.
Thiscreatesariskoninsufcientventilation.
Make sure alarm limits are appropriate for the patient and actual situation. Otherwise, there
is a risk on harming the patient, which can occur since the range of alarm limit settings is
broad.
In Jet Mode intratracheal pressures measured may be slightly underestimated as compared
to actual pressure due to the venturi effect. This creates a risk of too high airway pressures.
To avoid risk of electric 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 CO2sensor port simultaneously with the patient.
Table 1.1 List of applicable warnings
1.8 Generic cautions
Cautions
The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
The internal dead volume of Evone, excluding endotracheal tube, is 42 mL when using the
Evone Breathing Tubing and 52 mL when using the Evone conventional tube adapter, which
mayinuenceventilationefciencyforpatientswithalowrespiratoryvolume.
Evone is designed conforming the IEC 60601-1-2 EMC standard but non-conforming equipment
caneitherbeinuencedbyormayinuenceEvone.
The achievable minute volume of Evone can be not higher than 9 L/min – depending on
patient characteristics - which should be taken into account for clinical situations that
usually require higher minute volumes.

Safety
9
1
Keep Evone away from high capacity transformers, electric motors and other devices which
maycreatestrongelectromagneticelds.Pleasenotethatthismedicalequipmentcomplies
with the requirements of the applicable EMC-standards. Electronic equipment exceeding the
radiationlimitsdenedintheEMC-standardsmayaffecttheworkingofourequipment.
Table 1.2 List of applicable cautions
1.9 References
1Schmidt, J. et al. Glottic visibility for laryngeal surgery: Tritube vs. microlaryngeal tube:
A randomised controlled trial. Eur J Anaesthesiol 36, 963–971 (2019).
2Schmidt, J. et al. Improved lung recruitment and oxygenation during mandatory ventilation
with a new expiratory ventilation assistance device: A controlled interventional trial in healthy
pigs. Eur J Anaesthesiol 35, 736–744 (2018).
3Spraider, P. et al.Individualizedow-controlledventilationcomparedtobestclinicalpractice
 pressure-controlledventilation:aprospectiverandomizedporcinestudy.Crit Care 24,
662 (2020).
4Schmidt, 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).
5Weber, J. et al. Flow-controlled ventilation (FCV) improves regional ventilation in obese
 patients–arandomizedcontrolledcrossovertrial.BMC Anesthesiology 20, 24 (2020).
6Weber, J. et al. Flow-controlled ventilation improves gas exchange in lung-healthy
 patients—arandomizedinterventionalcross-overstudy.Acta Anaesthesiologica Scandinavica
64, 481–488 (2020).
7 Barnes,T.&Enk,D.Ventilationforlowdissipatedenergyachievedusingowcontrolduring
both inspiration and expiration. Trends in Anaesthesia and Critical Care 24, 5–12 (2019).
8Barnes, T. et al. Minimisation of dissipated energy in the airways during mechanical
 ventilationbyusingconstantinspiratoryandexpiratoryows-Flow-controlledventilation
(FCV). Med. Hypotheses 121, 167–176 (2018).

Instructions for Use Evone
10
2 System description
Evone consists of the Evone Control Unit and the Evone Breathing System.
TheEvoneBreathingSystemexistsintwocongurationsandconsistsofthefollowingparts:
• Evone Cartridge
• Evone Airway Adapter
• Humid-Vent Filter Pedi straight
• Evone Breathing Tubing or Evone Conventional Tube Adapter
Evone’s required 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)
• Articial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 numbered parts are described in the table 2.1.
Figure 2.1 Evone Control Unit
Front Back
8 8
8 8
910
11
12
13
23
4
5
6
7
1
Right side
5
6
4
Left side
14
19
20

System description
11
2
15 16
17 18
Figure 2.2 The detachable parts of Evone Control Unit

Instructions for Use Evone
12
Component Description component
1 Touch screen
2 Handle to carry the device
3 Holder to place the CO2sensor when it’s not being used
4 Area to place the Evone Cartridge
5Rotating valve to pinch the silicone tube in order to switch between
inspiration and expiration
6 Locking pin to keep breathing system in place during use
7Release-button to release breathing system from control unit
8 CO2sensor cable holder
9 High pressure medical oxygen inlet
10 High pressure medical air inlet
11 Serial data port to transfer real-time data
12 CO2sensor port
13 Power cable connector
14 Stand-by button
15 Mainstream CO2sensor + connecting cable
16 Power Cable
17 High pressure oxygen tubing
18 High pressure air tubing
19 Alarm light indicator
20 SD-card holder
Table 2.1 Description of components indicated in Figures 2.1 and 2.2

System description
13
2
A5
A6
A4
A1A2A3
A9
A7
A8
Front Back A3A2A1
A4
A8
A6
A5
A7
A
D1
A
D2
B D
D3
CD4
E
E1 E2
2.2 EvoneBreathingSystem
TheEvoneBreathingSystemexistsintwocongurations,whicheitherincludetheEvoneBreathing
TubingortheEvoneConventionalTubeAdapter.Allpartsareshownbelow.Additionally,anarticial
lung(notshown)isrequiredtoperformstartupchecks.Preferably,thearticiallunghasavolume
of 1 L and a compliance of 25 mL/cmH2O. Materials are further explained in Table 2.2.
Figure 2.3 Evone Breathing System (A-E)

Instructions for Use Evone
14
#EvoneBreathingSystemandadditionalmaterial
A Evone Cartridge (Ventinova Medical B.V., single use)
A1 Jet inlet port
A2 FCV®inlet port
A3 Pressure lumen port
A4 Patient outlet port
A5 Pressure lumen
A6 Pressure lumen connector for connection to pressure lumen
(Tritube or Evone Conventional Tube Adapter (CTA))
A7 Lockinghole,enablesxationofcontrolunitlockingpin
A8 (Exhaled) gas outlet
A9 Handle to push cartridge upwards
BEvone Airway Adapter (Ventinova Medical B.V.) to facilitate CO2measurement
CHumid-VentFilterPedistraight(Teleex,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 endotracheal tube
E Evone Breathing Tubing (Ventinova Medical B.V., single use)
E1 15 mm OD connector for connection to HMEF
E2 Male Luer lock to connect to Tritube ventilation lumen
F Endotracheal Tube (Tritube or conventional adult endotracheal tube,
single or double lumen)
G Trolley (optional)
Table 2.2 Description of (subparts of) Evone Breathing System and accessories

System description
15
2
F
F
2.3 Accessories
2.3.1 Tritube
Tritube can be used with Evone in combination with the Evone Breathing 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

Instructions for Use Evone
16
G G
2.3.3 Trolley
Evone can be placed on a trolley (G) which is an optional accessory. See Figure 2.6 A and B.
Figure 2.6 A Figure 2.6 B
Example how to place Evone on the trolley Evone on the Trolley
2.4 Distributed Information System
Evone facilitates being part of a Distributed Information System. Information including alarm
statuses, setting changes and measured clinical data is send via the serial port and may be used
for information purposes. In the Device settings menu ‘Basic hospital Data’ shall be chosen as the
data 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 standard RS232 cable can be used to make connection to a third ‘communication’ party.
• The third party shall write a ‘driver’ to interpret the transmitted data and supply it into
the Patient Data Management System.
• Miscellaneous data
- Charge Status
- Alarm Mute
- Ventilation status
 - Useralarmconrm
- Ventilation mode
- JET mode take CO2sample
- System to shut down

Ventilation Principle
17
3
3 Ventilation Principle
Evoneisamechanicalmedicalventilator,basedoncontrolofbothinspiratoryandexpiratoryow
(FCV®). Evone enables full ventilation of a patient through a small bore lumen.
Ventilation is guided by intratracheal pressure measurements and controlled by a pressure
compensatedowcontroller.Evonehastwodifferentoperationmodes:
1FCV®Mode for full ventilation in elective situations for maximally 72 hours.
To be used with all tubes.
2Jet Mode, which 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deated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ow
in the whole ventilation cycle.
FCV®ventilationcanonlybeappliedwhenthecuffoftheendotrachealtubeisfullyinated,
sealing off the trachea from the ambient atmosphere.
The FCV®ventilationcycleisgovernedbyfouroperatorsettingsonly,asclariedinFigure3.1:
• Inspiration Flow
• I:E ratio
• Peak pressure
• EEP (end expiratory pressure)

Instructions for Use Evone
18
Note that Frequency, Minute Volume and Tidal Volume cannot be set directly.
Figure 3.1 FCV® Mode intratracheal pressure prole
In Figure 3.1 a typical sequence of two FCV®breathing cycles is shown. In FCV®Mode the
inspiration is performed with the set (constant) Inspiration Flow until the intratracheal pressure
reaches the set Peak pressure. The device then starts the (assisted) expiration phase until EEP
isreached.Theexpirationowiscontrolledinorderto:
Aestablish a (roughly) linearly reduction of the intratracheal pressure until the set EEP
Bto ensure the set I:E ratio is reached.
Ingeneral,therearenoperiodswithoutowduringFCV®ventilation:gassesoweitherinto
oroutofthelungs.Thereforeonlythesetow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 expiratory pressure (NEEP; max -10 mbar) can be set.
However, this is strictly limited to the clinical situation of hypovolemia/hemorrhagic shock
(see 6.5.3).
Warning: Depending on the ventilation settings there might be a Peak/EEP overshoot
of 1-2 mbar. Overshoot is often seen during Tube in Tube usage or in smaller airways.
The resulting tidal volumes are correctly displayed on the right hand side of
the main screen.
Time
Intratracheal pressure
EEP
Peak
0
Inspiration Expiration Inspiration Expiration

Ventilation Principle
19
3
Time
Intratracheal pressure
PIP
alarm
limit
0
PP
alarm
limit
Inspiration
Passive
expiration
PIP = peak inspiratory pressure
Inspiration
Passive
expiration
PP = pause pressure
3.2 Jet Mode
The Jet Mode, can be postoperatively used to liberate the patient from mechanical ventilation
and to stimulate spontaneous breathing. The maximum driving pressure is limited to 1.5 Bar.
Jet mode shall only be used with Tritube, not with conventional endotracheal tubes, with the
cuffofTritubefullydeatedtoenableexpiratorygasestofreelyegress.
Warning:ThecuffmustbedeatedbyhandbeforeJetModecanbestarted.
Risk on barotrauma.
Warning:Thecuffmustbecheckedforaccumulateddebrisbeforedeation.
Risk on infection.
Warning: Do not use the Jet Mode in combination with the Evone Conventional
Tube Adapter. Risk of barotrauma.
Warning: Do not use mode for longer than 30 minutes on a single patient.
Risk of dehydration.
The Jet cycle is governed by 3 operator settings being:
• Frequency
• Inspiration Percentage
• Driving Pressure
Figure 3.2 Jet Mode intratracheal pressure

Instructions for Use Evone
20
In Figure 3.2 a typical sequence of Jet breathing cycles is shown. During the inspiration phase
the device maintains a constant driving pressure on the tube. This set constant driving pressure
is controlled by a set frequency and inspiration percentage. During inspiration Intratracheal
pressureisexpectedtostaybelowtheconguredPeakInspiratoryPressure(PIP)alarmlimit.
During expiration, which is passive, the intratracheal pressure is expected to decrease below
theoperatorconguredPausePressure(PP)alarmlimit,ifnot,theoperatorisnotiedbyan
alarm and the ventilation cycle is interrupted.