Mechanical Ventilator Milano (MVM) DRAFT User Manual

Mechanical Ventilator Milano (MVM)1

DRAFT User Manual2

Complete Guide to Setting Up and Operating the MVM3

Compilation time (for development): 2020-04-15 09:40:56Z4

The MVM Collaboration5

MILANO VENTILATORE MECCANICO

6

1

Contents1

Contents i2

List of Figures iv3

List of Tables v4

1 Introduction 25

1.1 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

1.2 Related documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

1.3 What is MVM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

1.4 MVM components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

1.5 Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 710

1.5.1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 711

1.5.2 Included components and required equipment . . . . . . . . . . . . . . . . . . . 912

1.5.2.1 Included components . . . . . . . . . . . . . . . . . . . . . . . . . . 913

1.5.2.2 Required component . . . . . . . . . . . . . . . . . . . . . . . . . . . 914

2 Modes of Ventilation 1215

2.1 Pressure Controlled Ventilation (PCV) . . . . . . . . . . . . . . . . . . . . . . . . . . 1316

2.2 Pressure Support Ventilation (PSV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1517

3 Description of Controls 1718

3.1 Manual Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1819

3.1.1 MVM Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1820

3.1.2 MVM Unit Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1821

3.1.2.1 Powering device ON . . . . . . . . . . . . . . . . . . . . . . . . . . . 1922

3.1.2.2 Powering device OFF . . . . . . . . . . . . . . . . . . . . . . . . . . 2023

3.2 GUI Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2024

3.2.1 Ventilation Mode Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2025

3.2.2 Changing Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2226

3.2.2.1 PCV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2227

3.2.2.2 PSV Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2328

3.2.3 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2429

3.2.3.1 Waveform Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2530

4 Operation of the MVM 2731

i

4.1 Preparation for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

4.1.1 Safety inspection of MVM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

4.1.2 Maintenance logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

4.1.3 Connecting the MVM ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . 304

4.1.3.1 Overview of MVM connections . . . . . . . . . . . . . . . . . . . . . 305

4.1.3.2 Make connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316

4.1.4 Check ventilator functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337

4.1.5 Ventilator function tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 338

4.1.6 Leakage and obstruction tests . . . . . . . . . . . . . . . . . . . . . . . . . . . 339

4.1.7 Check Medical air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3410

4.1.8 Check O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3411

4.1.9 Test alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3412

4.1.10 Test power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3513

4.1.11 Ventilator Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3514

4.2 Using with a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3515

4.2.1 Connecting a patient to the ventilator . . . . . . . . . . . . . . . . . . . . . . . 3516

4.2.2 Beginning ventilation with a connected patient . . . . . . . . . . . . . . . . . . 3617

4.2.3 Select Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3818

4.2.3.1 Setting positive end expiratory pressure (PEEP) . . . . . . . . . . . . 3919

4.2.3.2 Setting maximum inspiratory pressure . . . . . . . . . . . . . . . . . . 4020

4.2.3.3 Setting Fraction of Inspired Oxygen (FIO2) . . . . . . . . . . . . . . . 4121

4.2.3.4 Accessing the settings menu for pressure-controlled ventilation (PCV)22

or pressure-supported ventilation (PSV) . . . . . . . . . . . . . . . . 4123

4.2.3.5 Setting inspiratory pressure (Pinsp) . . . . . . . . . . . . . . . . . . . 4324

4.2.3.6 Setting respiratory rate (RR) . . . . . . . . . . . . . . . . . . . . . . 4325

4.2.3.7 Setting I:E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4526

4.2.3.8 Setting trigger pressure (Ptrig) . . . . . . . . . . . . . . . . . . . . . . 4527

4.2.3.9 Setting trigger flow (Ftrig) . . . . . . . . . . . . . . . . . . . . . . . . 4528

4.2.3.10 Setting support pressure (Psupp) . . . . . . . . . . . . . . . . . . . . . 4529

4.2.3.11 Setting minimum respiratory rate (RRmin) . . . . . . . . . . . . . . . 4530

4.2.4 Special functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4531

4.2.4.1 Inspiratory hold maneuver . . . . . . . . . . . . . . . . . . . . . . . . 4532

4.2.4.2 Expiratory hold maneuver . . . . . . . . . . . . . . . . . . . . . . . . 4533

4.2.5 Set Alarm Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4534

4.2.6 Monitor and Respond to Warnings . . . . . . . . . . . . . . . . . . . . . . . . 4635

4.2.7 Graphics displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4736

4.2.7.1 Selecting Waveforms to Display . . . . . . . . . . . . . . . . . . . . . 4737

4.2.7.2 Freezing Waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . 4838

4.2.7.3 Monitored parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 5139

4.2.8 Disconnecting a patient from the ventilator . . . . . . . . . . . . . . . . . . . . 5140

4.2.9 After Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5141

5 Patient safety 5242

5.1 Protective devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5343

5.2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5344

5.3 Rebooting MVM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5745

ii

6 Maintenance and troubleshooting 601

6.1 Routine Replacements And Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . 612

6.2 Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 633

6.2.1 Recommended cleaning solutions . . . . . . . . . . . . . . . . . . . . . . . . . 634

6.3 Full Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 685

6.4 Preparing for Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 736

6.5 Returning from Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 747

6.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 758

6.6.1 Minute Volume Too Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 759

6.6.2 Airway Pressure Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . 7610

6.6.3 Technical trouble — Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7711

6.6.4 Technical trouble — Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . 7712

6.6.5 Technical trouble — Minute volume . . . . . . . . . . . . . . . . . . . . . . . . 7713

6.6.6 Technical trouble — Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7714

7 Technical information 7915

7.1 Accuracy of the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8016

7.2 Component List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8117

7.3 Components Included in the Package but External to MVM . . . . . . . . . . . . . . . 8118

7.4 Connection to mains and battery operation . . . . . . . . . . . . . . . . . . . . . . . . 8219

7.5 Contents of the Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8220

Glossary 8321

References 8522

A Technical Diagrams for Ventilation Modes 8623

A.1 Device structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8624

A.2 Pressure Controlled Ventilation (PCV) . . . . . . . . . . . . . . . . . . . . . . . . . . 8825

A.3 Pressure Supported Ventilation (PSV) . . . . . . . . . . . . . . . . . . . . . . . . . . . 8826

A.4 Function chart legenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9027

B Regulatory agencies approval documents 9128

C Symbols and Labeling 9229

30

iii

List of Figures1

2.1 H! Example for pressure waveform in pressure-controlled ventilation (PCV) . . . . . . . 132

2.2 H! Example for pressure waveform in PSV . . . . . . . . . . . . . . . . . . . . . . . . 153

3.1 Illustration of the MVM setup, with manual controls identified in red . . . . . . . . . . 184

3.2 A view of the back of the MVM, with connections and controls labeled. . . . . . . . . . 195

3.3 Control panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

3.4 PCV Settings Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

3.5 PSV Settings Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

3.6 Setting Respiratory Parameter Values . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

3.7 Numerical display box on control panel . . . . . . . . . . . . . . . . . . . . . . . . . . 2410

3.8 Frozen waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2611

4.1 Example ventilator maintenance log.FG: placeholder until version specific to12

this ventilator is available . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3013

4.2 The MVM controller base assembly with connections as viewed from the rear of the unit. 3014

4.3 Table of all alarms from ISO 80601-2-12 (2020) . . . . . . . . . . . . . . . . . . . . . 4615

A.1 MVM Illustration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8716

A.2 Function-chart for PCV mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8817

A.3 Function-chart for pressure-supported ventilation (PSV) mode . . . . . . . . . . . . . . 8918

A.4 Function-chart legenda mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9019

C.1 Labels typically found on equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9320

C.2 Labels typically found on GUI/BDU . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9421

C.3 Shipping carton labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9422

C.4 Shipping carton labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9523

24

iv

List of Tables1

2.1 Default requirements for pressure-controlled ventilation (PCV). . . . . . . . . . . . . . 142

2.2 Default requirements for PCV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

6.1 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 624

6.2 Cleaning Methods and Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 725

6.3 LOWER ALARM LIMIT for EXPIRED MINUTE VOLUME . . . . . . . . . . . . . . . . 756

6.4 LOWER or UPPER PRESSURE LIMIT for AIRWAY PRESSURE has activated an alarm 767

6.5 Ventilator operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 778

6.6 Pressure-related malfunctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 779

6.7 LOWER or UPPER ALARM LIMIT for EXPIRED MINUTE VOLUME has been activated 7710

6.8 O2 cell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7811

12

v

Todo list1

Stephen,I did not see any reference to end of line Test for the MvM, This will impact scalability,2

need to be addressed. Gualtiero Magni, CTO-Corporate Project Management Dir. (Anne3

adds: I don’t know where end-of-line goes. . . . . . . . . . . . . . . . . . . . . . . . . . . 334

Procedure for changing ventilation parameters or mode while ventilator is connected to a patient5

and in operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356

From April 14 mtg - this list should be relocated to a more appropriate section of the manual, or7

perhaps only in the technical manual (JH) . . . . . . . . . . . . . . . . . . . . . . . . . . 618

from MitchK pres 5Apr, fluidics sl 5 (anne) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 619

vi

LIST OF TABLES 0–1

‘1

Mechanical Ventilator Milano (MVM) MVM User Manual

Chapter 1: Introduction 1–2

Chapter 11

Introduction2

Contents3

4 1.1 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

1.2 Related documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

1.3 What is MVM? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

1.4 MVM components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

1.5 Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

1.5.1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 710

1.5.2 Included components and required equipment . . . . . . . . . . . . . . . . 911121314



1.1 Intended Audience1

Minimum FDA requirement? yes Content correct? no Content Complete? no2

The intended audience for this document includes hospital staff who will have to set up the MVM3

unit and prepare it for use, staff who will use the MVM to ventilate patients, as well as staff who4

will be performing regular maintenance on the device.5

1.2 Related documents6

Reference manuals and documentation that comes with the device includes:7

• User’s manual, This Manual, intended for technical hospital staff who will setup and per-8

form regular maintenance on the device9

• Operator’s manual, intended for medical professionals treating a patient directly SSW: This10

should be the least technical manual, and it should largely be a subset of the11

User’s manual12

• Technical manual, intended for technicians who may need to know the more specific details13

of how the device works. SSW: This should be the most technical document, with14

technical drawings and diagrams15

In addition to these documents, the following resources are available online: SSW: Eventually16

turn these into links17

• Online versions of the above documents, mvm.care/documents18

• Video instructions showing how to setup and operate the device, mvm.care/documents19

• A virtual ventilator to practice use, mvm.care/documents20

• Contact information for additional questions, mvm.care/help21

1.3 What is MVM?22

The MVM is a pressure-regulated mechanical ventilator for intensive care units designed for23

COVID-19 patients.24

1.4 MVM components25

The MVM is made of a box containing the instrumentation to be connected to external equipment26

and its cart. The MVM can be controlled by a touch screen control panel.27


mvm.care/documents

mvm.care/documents

mvm.care/documents

mvm.care/help


Front view

Touch screen display: Control paneland graphics display. See section 3.2.

ON/OFF switch: A button for turningthe device on and off with a lock to preventaccidental presses. Hold button for 5 s to turnoff.

Power indicator: A light indicating thepower supply to the device. If the device is on,this light should be lit. Green means the powersupply is properly functioning, yellow meansit is running on battery backup, and flashingyellow means the battery is nearly out of power.

Opening screw: Remove this screw toopen the enclosure and access internal compo-nents. Only trained personnel should do this.

Alarm lights: Indicator lights signifyingan alarm. See section 5.2.

Alarm buzzer: Buzzer to issue a soundwhen an alarm goes off. See section 5.2.

Alarm silencer: Button to temporarilydismiss an alarm. See section 5.2.

Left side view

Anti-asphyxiation valve: Safety valveto allow patient to inhale while the inspiratoryvalve is closed. See section 5.1.

APL pressure relief valve: Maximum pres-sure relief valve, to prevent over-pressurizingand damaging patient. See section 5.1

Air/O2 inlet: Connects to the air/O2source. See section ??.



anne: LLee: The presence of the Anti-Asphyxia valve would also allow patient generated1

breaths under all modes, making another kind of IMV mixing unsupported breaths with2

supported breaths. It is not clear what the settings of the Anti-Asphyxia valve are.3

When Backup is Enabled, it is not clear from the manual whether or not the mandatory4

breaths are triggered, or occur on a time schedule. If the former, it would be a form5

of Synchronized IMV (SIMV). If the latter, it would be IMV alone. SSW: I had asked6

someone else about this (I forget who...maybe it was Patricia or Laurent) and was told7

that the anti-asphyxia valve would not be sufficient to allow for patient-generated8

breaths. It is a backup to provide safety, but not a “normal” breathing condition9

we would want.10

Right side view

Connection to patient circuit: Pa-tient circuit connection port. See section ??.

Connection to expiratory leg pres-sure sensor: Port connecting pressuretransducer to expiratory leg of patient circuit.See section ??.

Connection for expiratory valve con-trol line: Port for pneumatic line controllingexpiratory valve on patient circuit. Seesection ??.

Connection to patient pressure sen-sor Pneumatic connection to measure thepressure at the Y of the patient circuit. Seesection ??.

Ethernet port: Port for connecting toexternal devices.

USB port: Port for connecting to ex-ternal devices.

Connection to power supply: Port forconnecting the device to the power source.See section ??.



Device on its cart

Cart: The stand on which the devicewill sit while in use

Patient circuit: The circuitry leadingto the intubated patient.

Touch-screen control panel

User interface: Panel for setting therespiratory rate, I:E ratio, ventilation modeand settings, and alarm settings. Seesection 3.2



1.5 Before You Get Started1

1.5.1 Safety2

General Information• MVM is used for treating patients who require temporary respiratory support for diverse medical causes.• MVM must be operated only by authorized personnel who are well trained in its use. It must be operated according to the

instructions in the users’ manual.• Warning: risk of contamination for reuse of single use accessories. TM: List of single use accessories:TBD• After unpacking, the ventilator must be tested and, if necessary, calibrated.• All data on pressures for MVM are given in cmH2O.• Unit conversions:

– 1mbar=1 cmH2O– 1 kPa (kilopascal) = 10 cmH2O– 1 bar = 1 atm = 1– 100 kPa = 1 bar = 15 psi

• Responsibility for the safe functioning of the equipment reverts to the owner or user in all cases in which service or repairhas been done by a non-professional, and when the equipment is used for other than its intended purpose.

• A full technical description — including circuit diagrams, parts list and service data — is contained in the service documen-tation, copies of which are available from mvm.care/documents

• This device is intended for use be used on adult patients weighing minimally XXX.• Antistatic or electrically conductive hoses or tubing are not to be used in MVM.

3

Connections• The ventilator must be constantly monitored while connected to a patient.• A pre-use verification must be carried out before connecting a patient to the ventilator.• Never connect or disconnect auxiliary equipment to the outlet on the rear of the ventilator when the ventilator is connected

to mains.• WARNING: Pay attention to the tubes position while moving patient connected to the ventilator• All gases must fulfill medical-grade gas specifications. Supplied gases must be dry and free from oil and dust.

Air H2O <5 g · m−3

Oil <0.5 mg · m−3

Oxygen H2O <20 mg · m−3

4

Cleaning• To reduce the risk of infection to both hospital staff and patients, the device must be cleaned and disinfected after every

use.• External surfaces of the ventilator should be cleaned and wiped with appropriate disinfectant products between patients.• Bacterial/viral filters must be changed with a frequency consistent with hospital protocol, and at least every 24 hours to

48 hours and between patients for expiratory filters• anne: Identification of which portions of the gas pathways through the ventilator can become contaminated

with body fluids or by contaminants carried by expired breathing gases during normal conditions and duringsingle fault conditions

5


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Environment of use• MVM is intended for stationary use in hospitals and medical rooms within the hospital.• Do not cover MVM or place it in a position that affects proper operation or venting, thereby interfering with patient

ventilation:– WARNING: Do not position next to a curtain that blocks the flow of cooling air, thereby causing the equipment to

overheat.– WARNING: Do not block the gas intake port or emergency intake port.

• MVM must not be used:– In hyperbaric chambers– For magnetic resonance imaging (MRI, NMR, NMI)– In conjunction with flammable gases or flammable solutions that can mix with air or oxygen– In areas of explosion hazard– In areas with combustible or explosive substances– In rooms without sufficient ventilation

JH: Recommended disclaimer text from FDA EUA Expectations for Novel Ventilator Testing memo of April 7:This ventilator has not been tested for electromagnetic compatibility (EMC). It may produce electromagneticdisturbances that will affect the performance of other equipment. It may fail to perform as expected inthe presence of electromagnetic disturbances from other equipment.

1

Service• MVM must be serviced at regular intervals by specially trained personnel. Any maintenance must be documented for that

purpose, in accordance with national regulations.• Preventative maintenance and technological safety checks must be done regularly, in accordance with local regulations, with

a minimum of twice per year at six month intervals• Service and repairs on the ventilator may be done only by authorized personnel.• Only original parts from MVM or approved equivalents must be used in the ventilator.

2

Maintenance• Warning: maintenance and calibration to be performed only by authorized personnel . Device performances and safety not

guarantee otherwise.• Warning: Check that the device is not connected to mains before maintenance.• Warning: Check protective earth resistance periodically and after maintenance• Warning: Check leakage currents periodically and after maintenance according to EN 62353• Warning: Dispose of the electrical equipment according to WEEE directive.• Warning: Never use oil or grease based lubricants on oxygen equipment.• Warning: Never use silicone based compounds (i.e. lubricants) around oxygen sensors.

3

Operations• WARNING: The responsible organization must ensure that the oxygen source is compatible with the rated range of pressure,

flowrate and oxygen concentration as marked on the MVM and indicated in the instructions for use as this can affect theMVM performance and result in patient death or serious deterioration of health.

• The APNEA ALARM is not intended to and will not monitor for disconnections.• In the case of a power failure, the machine will be sustained on battery power for no more than 120min. A manual ventilator

should be used in place of this device for power outages beyond this duration• WARNING: Do not use for inlet pressure < 4 bar• WARNING: Failure to have an alternative means of ventilation such as a self-inflating, manually-powered resuscitator (as

specified in ISO 10651-4:2002) with mask can result in patient death if MVM fails.• WARNING: The ventilator shall not be used with inlet gases, which are not specified for use (e.g. helium or mixtures with

helium). Such use might cause the ventilator to not function correctly, causing patient death or serious deterioration ofhealth.

• WARNING: The ventilator shall not be used with inlet gases that are not specified for use (e.g., helium or mixtures withhelium). Such use might cause the ventilator to function incorrectly, causing patient death or serious deterioration of health.

• WARNING: The ventilator accuracy can be affected by the gas added to the ventilator breathing system by use of apneumatic nebuliser.

• WARNING: When using nebulisation or humidification, breathing system filters and heat and moisture exchangers mayrequire more frequent replacement to prevent increased resistance and blockage.

4



Equipment combinations• Only the accessories indicated on the following list of accessories have been tested and approved for use with this device.

Therefore, it is strongly recommended that only these accessories be used in conjunction with it. Otherwise, the correctfunctioning of the device may be compromised.

– Patient circuit– Humidifier– Condensate trap– Medical oxygen/air source– Bacterial/viral filters

• To maintain system safety and integrity, only accessories compliant with IEC 60601, or the safety of which has been verifiedin another way, may be connected to the signal outputs. For details on connections and allowed voltages, please see CircuitDiagram.

1

1.5.2 Included components and required equipment2

This section details the parts that come with the MVM, and what is needed to use it.3

1.5.2.1 Included components4

Ventilator: The MVM, including internalcomponents for controling ventilation andconnections to air/O2 source, power supply,and patient circuit

Cart: The stand on which the MVMrests

Battery backup: Backup power supplyin case of failure of primary power supply. Thebattery has a charge of 1.2 A · h and supplies12V for up to 120min

1.5.2.2 Required component5

The following are components that the user must supply in order to use the MVM. See the Technical6

Manual for suggested parts that satisfy each of these requirements.7



Gas supply: for medical air and O2 supplies,with associated lines that connect to themedical care flowmeters

Medical gas blender: for combiningair and O2 gas supplies at a desired Fractionof Inspired Oxygen (FIO2). The blender mustbe able to sustain a pressure up to XX, a flowrate up to XX, and an FIO2 in the range 21%to 100%.

Patient circuit: a single-limbed patientcircuit

HME Bacterial/viral filter: for pre-venting the patient from incoming bacteriaand viruses and for preventing the environmentfrom bacteria and viruses coming from thepatient

Expiratory valve: a pneumatatically-controlled diaphragm valve

positive end expiratory pressure (PEEP)valve: a standard PEEP valve for settingPEEP

Tube connections: gas tube connec-tions for controlling the expiratory valve andfor reading the pressure in the breathingsystem

Spare backup battery: a backup batteryto replace the one that comes with the MVM.The battery should have a charge of 1.2 A · h,and it should be capable of supplying 12V forup to 120min



HME bacterial/viral filters: for humidifyingair going into the patient, protecting the pa-tient from incoming bacteria and viruses, andfor protecting the environment from bacteriaand viruses coming from the patient. The fil-ters should enduce a pressure drop of no morethan 1 cmH2O/L/s.


Chapter 2: Modes of Ventilation 2–12

Chapter 21

Modes of Ventilation2

Contents3

4 2.1 Pressure Controlled Ventilation (PCV) . . . . . . . . . . . . . . . . . . . . . 135

2.2 Pressure Support Ventilation (PSV) . . . . . . . . . . . . . . . . . . . . . . . 156789



2.1 Pressure Controlled Ventilation (PCV)1

Figure 2.1: Example for pressure waveform in pressure-controlled ventilation (PCV).

The PCV mode is a time-cycled ventilation mode in which the rate of the pressure level changes2

is kept constant. The time-cycled change of pressure between the target inspiratory pressure3

(Pinsp) and the positive end expiratory pressure (PEEP) provides controlled ventilation. A new4

inspiration is initiated either after a breathing cycle is over, or by patient request at any time5

during expiration. For this latter case, the MVM triggers a new breathing cycle if MVM detects6

an sudden drop in pressure below a user-settable threshold (Inhale Trigger Threshold).7

The time pattern is set using the basic setting parameters of respiratory rate (RR) and inspiratory8

time I. The MVM calculates the resulting expiratory time E. MVM shows the respiratory rate9

and the I:E at the bottom of the monitoring screen below the waveform display.10

The target upper pressure level is configurable by inserting the value for the Pinsp parameter on the11

monitoring screen. Two safety mechanisms must be configured regarding the maximum allowed12

inspiratory pressure: a mechanical threshold set by adjusting manually the APL valve, and a digital13

threshold set as one of the breathing settings on the monitoring screen. The digital threshold needs14

to be lower than the mechanical threshold. The PEEP is set by mechanically adjusting the PEEP15

valve.16

The tidal volume (Vt) is monitored and not set. The tidal volume basically results from the17

pressure difference between requirements for PEEP and Pinsp. Changes in lung compliance and18

airways, as well as the patient’s active breathing, can lead to changes in tidal volume. This is a19

desired effect in this ventilation mode. Knowing that tidal volume, and therefore minute volume,20

are not constant, the alarm limits for minute volume must be carefully adjusted. The display of21

measured expiratory tidal volume Vt must be used to set the required difference between the Pinsp22

and PEEP levels.23

During PCV mode, the MVM measures the inspiratory pressure, the minute ventilation, the tidal24

volume and PEEP. PCV in MVM starts with a default set of values for the breathing cycle and25

alarm ranges, listed in 2.1; these values can be adjusted from the screen within permitted ranges,26



as described in table 4.1.10.1

Elena: Would it be best to have alarms when fundamental parameters are not set?2

Elena: We don’t have defined numbers for the fields marked with a question mark (?).3

The GUI currently has place holders for them. We need feedbacks from the medicals.4

Control Settings Default Range Step SizeRespiratory rate 12 b/min 4-50 b/min 1 b/minInspiratory time 1.5 sec 0.4-1.5 sec 0.1 secTarget inspiratory pressure 15 mbar 2-40 mbar ?Max inspiratory pressure (digital) ? ? ?Inhale Trigger Threshold ? cmH2O ?Mechanical Settings Default Range Step SizePEEP - 5-20 cmH2O mechanicalMax Inspiratory pressure (mechanical) - 20-80 cmH2O mechanicalFraction of Inspired Oxygen (FIO2) - 21-100 % mechanicalAlarms Default Range Step SizeInspiratory pressure ? 10-80 cmH2O 1 cmH2OTidal volume ? 50-1500 mL 50 mLMinute ventilation ? 2-20 slpm 1 slpm

Table 2.1: Default values and ranges for requirements and alarms of the PCV.5

MVM is not suitable for children or infants.6



2.2 Pressure Support Ventilation (PSV)1

Figure 2.2: Example for pressure waveform in pressure-supported ventilation (PSV).

In Pressure Support Ventilation, the ventilator in part takes over the work of breathing, with the2

patient maintaining control of the respiratory rate. PSV is not suitable for patients unable to3

breath spontaneously.4

Pressure support is started upon detection of an inspiration: if MVM detects a sudden drop in5

pressure below a user-settable threshold, it pauses for 0.2 sec and then it starts providing inspiration6

pressure support. Elena: Should MVM do this?7

The MVM then produces an increase in pressure up to the target Pinsp pressure, which is adjustable8

to the breathing requirements of the patient. The MVM allows exhalation when the inspiratory9

flow drops below a given fraction of the peak flow (Expiratory Trigger Setting), typically 30%.10

The flow-fraction threshold is also configurable as one of the breathing settings. As in PCV, the11

lowest pressure level is set by mechanically adjusting the PEEP valve.12

The PSV mode checks for the presence of apnea by recording the time elapsed from the last breath.13

If the patient does not take new breath for a length of time greater than the allowed apnea time, an14

alarm is triggered. The alarm lasts for (Elena: put the amount of time) sec. Pressure support15

is terminated if no action is taken during the duration of the alarm. In this case, the MVM auto-16

matically switches to the PCV mode with pre-determined settings. The time allowed for an apnea17

is a configurable parameter. Elena: This is not how MVM currently works, but this is18

what the medical community means for PSV. Or at least my understanding of it.19

The target inspiratory pressure level is configurable by inserting the value for the Pinsp parameter20

on the monitoring screen. Two safety mechanisms must be configured regarding the maximum21

allowed inspiratory pressure: a mechanical threshold set by adjusting manually the APL valve,22

and a digital threshold set as one of the breathing settings on the monitoring screen. The digital23



threshold needs to be lower than the mechanical threshold. The PEEP is set by mechanically1

adjusting the PEEP valve.2

During PSV mode, the MVM measures the inspiratory pressure, the minute ventilation, the tidal3

volume and the PEEP. PSV in MVM starts with a default set of values for the breathing re-4

quirements and alarm ranges, listed in 2.2; these values can be adjusted from the screen within5

permitted ranges, as describe in section ??.6

Elena: Would it be best to have alarms when fundamental paramters are not set?7

Elena: We don’t have defined numbers for the fields marked with a question mark (?).8

The GUI currently has place holders for them. We need feedbacks from the medicals.9

Control Settings Default Range Step SizeTarget inspiratory pressure 15 mbar 2-40 mbar ?Max inspiratory pressure parameter ? ? ?Expiratory trigger setting ? 5-20% of peak flow 1%Inhale Trigger Threshold 2 mbar/s/s ?Apnea Time ? ?Mechanical Settings Default Range Step SizePEEP - 5-20 cmH2O mechanicalMax Inspiratory pressure - 20-80 cmH2O mechanicalFIO2 - 21-100 % mechanicalAlarms Default Range Step SizeInspiratory pressure ? 10-80 cmH2O 1 cmH2OTidal volume ? 50-1500 mL 50 mLMinute ventilation ? 2-20 slpm 1 slpm

Table 2.2: Default values and ranges for requirements and alarms of the PSV.10

MVM is not suitable for children or infants.11


Chapter 3: Description of Controls 3–17

Chapter 31

Description of Controls2

Contents3

4 3.1 Manual Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

3.1.1 MVM Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

3.1.2 MVM Unit Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

3.2 GUI Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

3.2.1 Ventilation Mode Control . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

3.2.2 Changing Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2210

3.2.3 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2411121314



Two sets of controls are used for the MVM: manual controls, which must be adjusted physically,1

and GUI controls, which must be adjusted through the control panel.2

3.1 Manual Controls3

Figure 3.1: The MVM setup. Manual controls are identified in red

Figure 3.1 illustrates the MVM setup, with manual controls identified in red. The following controls4

are set manually:5

• MVM unit power (on/off), with the power switch (Section 3.1.2)6

• Fraction of Inspired Oxygen (FIO2), with the gas blender (Section 4.2.3.3)7

• Positive end expiratory pressure (PEEP) level (Section 4.2.3.1)8

• Adjustable pressure relief (APL) valve (Section 4.2.3.2)9

3.1.1 MVM Unit10

The controls present on the MVM itself can be seen in Figure 3.2, along with various connections11

and ports.12

The top of the MVM contains the control panel. All other MVM controls are set using the control13

panel (Section 3.2).14

3.1.2 MVM Unit Power Switch15

A power switch on the front of the device can be used to turn power on and off. A guard protects16

the switch from inadvertant operation.17



Air intake

EthernetUSB

spare e-stopLED

LED

adjustable pressure limiting valve

To patient circuit

Negative pressure relief

Power switch

Potential equalization

?

Power connector

Left to right: ports

P1-P4.

Will be removed

Figure 3.2: A view of the back of the MVM, with connections and controls labeled.

3.1.2.1 Powering device ON1

Push button to power on ventilator.

Remove the guard: Lift the guard over thepower switch

Power on MVM: Push the power but-ton located on the top of the main unit. TheGUI should appear on the control panel

Replace the guard: Lower the guardback over the power switch



3.1.2.2 Powering device OFF1


Remove the guard: Lift the guard over thepower switch

Power off MVM: Push the power but-ton located on the top of the main unit, andhold it for 5 s, until the control panel goesblank.

Replace the guard: Lower the guardback over the power switch

3.2 GUI Controls2

The control panel is a touch screen that (Figure 3.3) allows users to3

• Choose the ventilation mode,4

• Begin and end ventilation,5

• Set and modify ventilation parameters,6

• Monitor inspiratory and expiratory flow parameters, and7

• Respond to alarms.8

The controls are located at the bottom of the control panel. The upper portion of the screen is9

dedicated to monitoring.10

SSW: From FDA: Add more details about triggering on pressure and flow thresholds, min11

and max thresholds for breath delivery,12

3.2.1 Ventilation Mode Control13

MVM provides two ventilation modes:14

1. Pressure-controlled ventilation (pressure-controlled ventilation (PCV))15

2. Pressure-supported ventilation (pressure-supported ventilation (PSV))16

anne: make doc and panel consistent when we know what the final terms are17

The controls for starting a ventilation mode are in the lower right-hand corner of the control panel.18

For PCV mode, the parameters the user can set are:19

• respiratory rate (RR) in breaths per minute20

• I:E; I remains at 1; set the “E” value21



Figure 3.3: The MVM control panel. It displays graphical and numerical monitoring information forinspiratory pressure (Pinsp) (top), tidal volume (Vt) (middle), and Expiratory Volume per minute (MVe)(bottom of monitoring portion). The user controls are grey buttons at the bottom of the control panel.



• Pinsp in cmH2O1

For PSV mode, the parameters the user can set are:2

• Pressure Trigger in cm · s−2 anne: tenths of a mm per s sqd3

• Flow percentage to trigger end of inspiration, in %4

• Support Pressure in cmH2Oanne: this should be top of screen and first in list5

• Minimal RR in breaths per minute. If Enable Backup is on, the MVM will begin an inspira-6

tory cycle automatically if the patient’s RR falls below this value.7

anne: does enable backup really have to be enabled? Is this an alarm condition? And8

where is enable backup set? anne: what does the Back button do? And exp pause9

and insp pause are under discussion10

3.2.2 Changing Settings11

3.2.2.1 PCV Mode12

Figure 3.4: PCV Settings Display anne: fix mbar, automatic, other terms that arewrong; SP checking on whether we can set PEEP this way

Each parameter comes with a set of predefined values. To change the values in PCV mode, press13

“Settings.” To access the predefined values, press the value (as shown in Fig. 3.6) and the predefined14

options will appear. Select one or the user may press Cancel and use the + or − to set a differ-15

ent value. Or press “Load Presets” to reset the parameters to their previous values.anne: which16

values - what does preset mean here, previous or default? And what does default mean17

if there are several?18

To save the changes press “Apply” then “Close” to close this window. anne: need picture of19

pcv with defined values20



To discard your changes and return to the default or previously set values, simply press “Close.”1

anne: preset or default values? And apply should be to the left of close2

3.2.2.2 PSV Mode3

Figure 3.5: PSV anne: fix terms Settings Display

To change the ventilator settings for the PSV mode, open the settings panel as described in ???,4

make sure that the PSV tab is selected, then use the “+” and “-” buttons to change the values.5

Make sure to press “Apply” to save the changes. Pressing “Close” will discard the changes made.6

Figure 3.6: Setting Respiratory Parameter Values. Each parameter has a set of predefined values fordifferent circumstances. The user may select a predefined value or set a different value.

Each parameter comes with a set of predefined values. To access the predefined values, press the7

value (as shown in Fig. 3.6) and the predefined options will appear. Select one or cancel and use8



the + or − to set a different value. Press Apply to save your changes, then Close when you are1

finished.2

3.2.3 Monitoring3

The control panel displays these three parameters in real time:4

• inspiratory pressure (Pinsp) in cmH2O5

• tidal volume (Vt) in milliliters (ml)6

• Expiratory Volume per minute (MVe) in liters (l)7

The large monitoring portion of the control panel consists of three rows, one for each of the8

three parameters, showing time evolution graphically on the left, and selected data on the right9

(Figure ??).10

anne: instantaneous value not helpful; may need to change11

Figure 3.7: The structure of the numerical display box for each monitored quantity. The display for Pinspis shown. When the instantaneous value of the parameter goes outside the allowed range (above theupper alarm level or below the lower alarm level) the display box turns red and an audio alert sounds.

anne: I think this table should describe each full row, and have the semi-transparent12

overlay over the entire row; not split into two tables. TM: which table?13

On the left-hand side the control panel shows a graph of the values of the three main parameters14

Pinsp, Vt, MVe for the immediately preceding 10 seconds.15

anne: graph or waveform16



Inspiratory Pressure (Pinsp): The inspiratorypressure waveform, showing measured pressurein cmH2O vs. time in seconds. anne: oldimages with old control buttons

Tidal Volume (Vt): The tidal volume wave-form, showing measured tidal volume in mL vs.time in seconds.

Expired Minute Volume (MVe): The expi-ratory minute volume waveform, showing theexpired minute volume in mL ·min−1 vs. timein seconds.

3.2.3.1 Waveform Details1

To freeze the current waveform, press “Freeze.” This stops the waveform display from updating so2

that the user can examine it, as shown in Fig. 3.8. Use the arrows to move the waveform, and the3

“+” and “-” buttons to zoom in or out. Clicking Freeze will not stop ventilation, nor will it4

change settings. anne: Which arrows, bottom or right? Do the arrows move it left5

or right? They should point left or right. If not, it’s unclear what they do. When6

you zoom, does it take up more of the screen?7

To return to updating the waveforms, click “Unfreeze”.8



Figure 3.8: Frozen waveforms.


Chapter 4: Operation of the MVM 4–27

Chapter 41

Operation of the MVM2

Contents3

4 4.1 Preparation for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

4.1.1 Safety inspection of MVM . . . . . . . . . . . . . . . . . . . . . . . . . . . 286

4.1.2 Maintenance logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

4.1.3 Connecting the MVM ventilator . . . . . . . . . . . . . . . . . . . . . . . 308

4.1.4 Check ventilator functions . . . . . . . . . . . . . . . . . . . . . . . . . . . 339

4.1.5 Ventilator function tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3310

4.1.6 Leakage and obstruction tests . . . . . . . . . . . . . . . . . . . . . . . . . 3311

4.1.7 Check Medical air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3412

4.1.8 Check O2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3413

4.1.9 Test alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3414

4.1.10 Test power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3515

4.1.11 Ventilator Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3516

4.2 Using with a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3517

4.2.1 Connecting a patient to the ventilator . . . . . . . . . . . . . . . . . . . . 3518

4.2.2 Beginning ventilation with a connected patient . . . . . . . . . . . . . . . 3619

4.2.3 Select Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3820

4.2.4 Special functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4521

4.2.5 Set Alarm Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4522

4.2.6 Monitor and Respond to Warnings . . . . . . . . . . . . . . . . . . . . . . 4623

4.2.7 Graphics displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4724

4.2.8 Disconnecting a patient from the ventilator . . . . . . . . . . . . . . . . . 5125

4.2.9 After Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5126272829



4.1 Preparation for use1

(Frank Golf): editor2

Anne: did a bit more work 4/5 and 4/73

Prior to use each time, the following checks should be performed in the order listed. anne: steps4

to be checked5

FG: organized similar to Maquet user manual and drager evita. Need to verify that6

all steps listed are needed and that none are missing that should be here.7

1. Perform safety inspection of MVM unit (Section 4.1.1).8

2. Check maintenance log (Section 4.1.2).9

3. Make connections (Section 4.1.3).10

• Connect patient circuit.11

• Connect power.12

• Switch on the MVM.13

• Connect to gas supply.14

4. Check settings (Section 4.1.4).15

• Perform ventilator functionality tests.16

• Perform leakage tests. anne: needed with intubation? SSW: I think so – don’t17

want leaks in circuit SDA-GD: These tests are required also for invasive18

ventilation, as per https://www.ncbi.nlm.nih.gov/pubmed/3132693619

• Check O2.20

• Test alarms.21

• Test transition to/from battery power.22

5. Update maintenance log (Section 4.1.2).23

4.1.1 Safety inspection of MVM24

Review safety information

Before each use, reprocess the device and all the accessories according to the informationin the Instructions for Use (Section 1.5.1). Hospital infection control regulations must beobserved!

25

Engage casters to lock wheels

Lock all the castors and check correct operation of the brakes when parking the cart.26

Ensure accessories installed by trained personnel

The necessary accessories are to be installed by properly trained service personnel in accor-dance with the appropriate installation instructions.

27



Do not place liquids near device

Do not place any container with liquids (e.g., infusion bottle) above or on top of the venti-lator. Entry of liquid into the device could prevent it from working properly or damage itand endanger the patient.

1

Do not tilt device

Do not tilt or lean against the ventilator or cart; it could cause the ventilator to tip over.2

Avoid applying tipping forces to device

Observe the maximum permitted loads and centers of gravity to prevent ventilator fromtipping over.

3

Do not use cart if damaged

Do not use the cart in the event of visible damage e.g., damaged castors!4

Ensure secure attachments to cart

Attach devices securely to the cart to avoid risk of damage to the device or personal injury!5

Ensure proper zeroing of sensors

Make sure that the pressure transducers, oxygen sensors, and flow meters give appropriatelyzeroed readings. If not, see Section 4.1.11 (Calibration) or Section 6.6 (Troubleshooting).

6

If any malfunction is detected during the preparations, see Section 6.6.7

4.1.2 Maintenance logs8

Check the maintenance log prior to use and verify the following. Download the log file every9

XXX days.10

SSW: We need details on how the log will be implemented and how the user wlll interface11

with it12

• Clean the ventilator prior to use.13

• Inspect the main unit, the power supply unit, and all cables and hoses for signs of damage.14

If any is found, do not use the ventilator until a suitable replacement has been obtained and15

tested.16

• Verify that any regular, required maintenance has been performed.17

Whenever the device is cleaned, serviced, or found to perform out of specifications, make an18



appropriate entry in the maintenance log.1

Figure 4.1: Example ventilator maintenance log.

4.1.3 Connecting the MVM ventilator2

4.1.3.1 Overview of MVM connections3

The MVM is made of a main unit containing the ventilation mechanism and its controls and4

interface and a power supply unit. The power supply unit also contains a backup battery that5

provides 120min of autonomy. The MVM requires no assembly, apart from connection to the6

facilities and to the patient (Chapter 4.1). A CAD design of the MVM controller base assembly7

box is shown in Fig. 4.2.8

Air intake

EthernetUSB

spare e-stopLED

LED

adjustable pressure limiting valve

To patient circuit

Negative pressure relief

Power switch

Potential equalization

?

Power connector

Left to right: ports

P1-P4.

Will be removed

Figure 4.2: The MVM controller base assembly with connections as viewed from the rear of the unit.



FG: update once figures of box with connectors are updated, see below Connections to1

the air supply, power supply unit, and data ports are located on the top side of the ventilator box.2

The connection to the patient circuit and ports for control and sensor lines are located on the right3

side of the ventilator.4

FG: These figures need to be updated with the new version. FG: Figures similar to5

these appear in Chapter 1. Do we want to repeat these here?6

4.1.3.2 Make connections7

Connection procedure— connect the components of the MVM system. SSW: For8

future iterations, it would be good to complement these figures with drawings of various9

parts plugging into the MVM10

Connect expiration line pressure sensor here.

Connect expiration pressure sensor: Con-nect the expiration pressure sensor cable toport P4. FG: Update once further inforegarding cable types/colors/markersand port labeling are determined.

Connect patient pressure sensor here.

Connect patient pressure sensor: Connectthe patient sensor cable to port P3. FG:Update once further info regardingcable types/colors/markers and portlabeling are determined.

Connect expiratory valve control line here.

Connect expiration pressure valve control:Connect the expiration valve control cable toport P2. FG: Update once further inforegarding cable types/colors/markersand port labeling are determined.



Connect patient breathing circuit here.

Connect patient circuit: Connect the pa-tient breathing circuit to the output on theright side of the ventilator.

Connect power here.

Connect power: Connect the main unitto the power supply unit using the cableprovided. The cable must be firmly lockedand must stay in place at all times during op-erations.


Power on MVM: Push the power buttonlocated on the top of the main unit. Oncethe device has powered up, verify thatpressure, volume, and flow readings are 0.If any sensor report a non-zero value, seeSection 4.1.11 for calibration procedures.FG: Is there additional informationabout the startup that can be addedhere? e.g. things to look for onthe screen, LEDs to check, audiblesounds to listen for , etc. SSW: Idon’t know if this is still true,but at some point the plan was forthere to be a safety button that hasto be activated, to prevent powerfrom accidentally being turned on oroff.

Connect air/O2 here.

Connect air/O2: Attach one end of a hose(ISO 5356 M22/F15) to the gas supply inputand the other end to the output of the medicalgas mixer. Refer to the ’Instructions for Use’for the medical gas mixer for detailed setup andcare information.



Stephen,I did not see any reference to end of line Test for the MvM, This will impact scalabil-ity, need to be addressed. Gualtiero Magni, CTO-Corporate Project Management Dir. (Anneadds: I don’t know where end-of-line goes.

1

4.1.4 Check ventilator functions2

Before connecting the patient to the breathing circuit, the following checks of the MVM functions3

should be performed.4

• Perform ventilator functionality tests.5

• Perform leakage and obstruction tests. anne: needed with intubation?SSW: Yes, I6

think so SDA-GD: These tests are required also for invasive ventilation, as per7

https://www.ncbi.nlm.nih.gov/pubmed/313269368

• Check O2.9

• Test alarms.10

• Test transition to/from battery power.11

[We should have labeled diagrams of all of the monitors/pages the users will look at to check12

settings before connecting to a patient, showing what the initial values should all be]13

[Throughout this process, we should explain any changes that need to be made to any of the14

parameters, and what readings the user should check]15

After this, carry out a check on functions (described later) before connecting to the patient.16

FG: We need to develop a minimum checkout procedure required before safe operation17

with input from the mechanics, electrics, and software teams. If there are some automated18

tests we want run, we should specify test parameters, describe what is done, and how19

to understand test results. GD, SDA: Proposed text Perform the automatic check test, by20

.... drive through how to initialize check test in GUI. This test GD, SDA: commenting the line21

below on DP below 14 cmH2O22

Portions of the test descried below can be automatically performed by the ventilator, or may23

also require healthcare professional operator action. Example: Combination of power-on self-test24

routines and operator action.25

4.1.5 Ventilator function tests26

FG: Add information about ventilator function tests including verifying proper control27

of all valves. Verify that all valves are functioning properly.28

4.1.6 Leakage and obstruction tests29

FG: Add information about procedure for internal and breathing circuit leakage tests.30

An automated test of the circuit for leaks and obstructions should be performed after turning the31

MVM on.32



Before turning the MVM on, it should be connected to the air/O2 source, a power supply, and the1

patient circuit.2

Select “New Patient”

Select “Circuit Test”

Once the tests have been performed, the MVM will display a report on the status of leaks and3

obstructions in the circuit.4

4.1.7 Check Medical air5

The pressure of medical air is to be checked at the mixer level. The lower limit for this pressure6

is 2.8 bar. This part should be under the responsibility of the hospital infrastructure.7

4.1.8 Check O28

An alarm is required on O2 input pressure The lower limit for this pressure is 2.8 bar. This part9

should be under the responsibility of the hospital infrastructure.10

FG: Add information about procedure to check O2. The oxygen pressure is to be checked at11

the mixer level.12

4.1.9 Test alarms13

At the end of the automatic procedure no alarm should be present on the screen, and no red light14

should be present on the MVM.15

FG: Add information about procedure to test all alarms.16



4.1.10 Test power supply1

FG: Add information about procedure to test operation from AC and battery power sources.2

Test the backup battery by unplugging the connections to the power. The ventilator power alarm3

should be present, but the ventilator should be running, showing the alarm and the time remaining4

to re-establish the power. This time should be above 30 minutes.5

Reconnect the plug to the power line at the end of the test. The power failure alarm should6

disappear.7

Check the remaining battery life (explain how in the panel)8

The remaining operational life time of the battery should exceed 15 days.9

4.1.11 Ventilator Calibration10

FG: Add information any necessary calibration procedures for proper operation or monitoring11

of device.12

Procedure for changing ventilation parameters or mode while ventilator is connected to a pa-tient and in operation.

13

JH: Should be able to bump-check oxygen sensor for atmospheric levels (20.9 percent)14

and enhanced levels (perhaps 100 percent?). May also need to calibrate touchscreen?15

Flow sensor could be calibrated for a "zero" and max flow (which should align with16

what the gas blender flow is indicating).17

4.2 Using with a Patient18

4.2.1 Connecting a patient to the ventilator19

cat: The following has an awful lot of steps, with a lot of words to read, after connecting20

to the patient. How many seconds can the hose be connected to the patient without21

yet delivering air to the patient? Looking at manuals for other ventilators, it seems22

more common to first turn the device on, make sure it goes through an internal check23

that all alarms are enabled, THEN connect the hose which delivers air, and then immediately24

push a START, which selects either "same patient" or "new patient". Both start air25

right away. Once air is being delivered, the steps for adjusting the cycle can be26

followed. If the MVM does not yet have a quick start like this, then it should27

Once the MVM has been turned on, the air/O2 source, power supply, and patient circuit have28

been connected to the MVM, and the pre-checks have all been performed, the MVM is an idle29

state and is ready to be connected to the patient.30

SDA GD: To ask to doctors.31



To establish this connection, attach the patient circuit to the patient’s endotrachael tube (or to1

the patient’s mask, if one is being used instead).2

4.2.2 Beginning ventilation with a connected patient3

After powering the device on, the user can begin ventilating a patient following the procedures4

below.5

1) Select initial parameter settings:• New Patient: A file for a new patient is

created, with default parameters loaded(continue to Step 2)

• Resume Ventilation: The most recentpatient’s file is loaded, and parametersare set to their previously set values(skip to Step 3)

2) Select new patient operation:• Start Ventilation: Go directly to the

main monitor and control page(continue to Step 3)

• Open Settings: Go directly to the set-tings page(See Section 4.2.3)

• Circuit Test: Perform an automatedcheck for leaks and obstructions in thecircuit. If leaks or obstructions are found,an alarm will be issued.(See Chapter 5.2)

3) View main monitoring & controls page:• Waveforms: Monitored waveform dis-

plays(See Chapter 4.2.7.1)

• Monitored Parameters: Values for pa-rameters measured in each breath(See Chapter 4.2.7.3)

• Status: Description of the current run-ning status(See Chapter ??)

• Menu: Open menu to adjust parametersand to perform functions(See Step 4)



4) Select settings and mode of ventila-tion:

• Settings: Adjust parameter settings fordesired mode of ventilation. Parametersshould be set prior to beginning ventila-tion, though they can be changed onceventilation has begun.(See Chapter 4.2.3)

• Set Assisted (to change: “Set PCV”):Set the ventilation mode to pressure-controlled ventilation (PCV)(See Step 5)

• Set Automatic (to change: “Set PSV”):Set the ventilation mode to pressure-supported ventilation (PSV)(See Step 5)

Other buttons:• Back: Return to the main monitoring

and control page• Settings: Adjust operation mode param-

eters(See Chapter 4.2.3)

• Inspir. Pause: Perform an inspiratoryhold maneuver(See Chapter 4.2.4.1)

• Expir. Pause: Perform an expiratory holdmaneuver(See Chapter 4.2.4.2)

• Freeze: Pause the waveform displaywhile continuing normal functions, en-abling zoom and shift of waveforms(See Chapter 4.2.7.2)

• Settings: Adjust parameter settings fordesired mode of ventilation. Parametersshould be set prior to beginning ventila-tion, though they can be changed onceventilation has begun.(See Chapter 4.2.3)



5) Begin ventilation:• Start Assisted or Start PCV (to change:

“Set PCV or Set PSV”): Begin ventila-tion with the selected mode(See Step 6)

6) Return to main monitoring and controlpage:

• Back: Return to the main page(See Step 7)

6) Monitor ventilating patient:• Monitored parameters, waveforms, and

alarms will appear on this page duringventilation

4.2.3 Select Parameters1

anne: From Patricia: What ventilator parameters will be set? a. Respiratory rate2

(time) b. Inspiratory/Expiratory ratio/times (time) c. Tidal volume (flow x time)(volume3

limiting bellows) NO d. Inspiratory flow rate (flow) e. Inspired Oxygen concentration4

(O2 flow) f. Peak inspiratory volume (high pressure relief valve)5

The following parameters may be set for PCV6



• Positive end expiratory pressure (PEEP): the positive pressure that will remain in1

the airways at the end of the respiratory cycle (end of exhalation) that is greater than2

the atmospheric pressure in mechanically ventilated patients; it is also the pressure at the3

beginning of the next inspiration4

• Maximum inspiratory pressure: the maximum pressure in the inspiratory leg of the5

circuit, above which the APL relief valve will crack, preventing the pressure from further6

increasing7

• Fraction of Inspired Oxygen (FIO2): the relative oxygen concentration of the air in the8

inspiratory leg of the circuit9

• Inspiratory pressure (Pinsp): the set pressure to supply the patient during the inspiratory10

cycle of PCV11

• Respiratory rate (RR): the number of breaths taken by the patient per minute, either12

fixed by a time trigger in PCV mode or measured from the rate of patient-triggered breaths13

in PSV mode14

• I:E: The ratio of inspiratory time over expiratory time15

The following parameters may be set for PSV16

• PEEP: the positive pressure that will remain in the airways at the end of the respiratory cycle17

(end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated18

patients; it is also the pressure at the beginning of the next inspiration19

• Maximum inspiratory pressure: the maximum pressure in the inspiratory leg of the20

circuit, above which the APL relief valve will crack, preventing the pressure from further21

increasing22

• Fraction of Inspired Oxygen (FIO2): the relative oxygen concentration of the air in the23

inspiratory leg of the circuit24

• Trigger pressure (Ptrig): pressure threshold for initiating the inspiratory threshold in25

patient-triggered breaths in PSV mode26

• Trigger flow (Ftrig): the percent flow relative to the peak flow at which the expiratory27

cycle will be triggered by the patient in PSV mode28

• Support pressure (Psupp): the set amount of pressure to apply in support of a patient-29

triggered breath in PSV30

• Minimum respiratory rate (RRmin): if a patient does not initiate a breath within the31

time window defined by this parameter, the MVM will issue an apnea alarm and switch to32

PCV mode33

Note that because PSV relies on PCV parameters for its response to patients’ failure to initiate34

a trigger on their own. When operating in PSV mode, the user should therefore also set PCV35

parameters.36

4.2.3.1 Setting PEEP37

The PEEP valve has a knob that can be adjusted by hand to a desired value. This valve is38

connected to the end of the expiratory limb of the patient circuit.39



Adjust the PEEP valve: Rotate the gaugeon the PEEP valve until it reads the desiredvalue.

Check PEEP level: Check the patient’sPEEP at the end of the next expiratory cycleto ensure that it is at the desired level SSW:Note: Placeholder image

4.2.3.2 Setting maximum inspiratory pressure1

The APL valve sets the maximum pressure that the MVM can provide to the patient, providing2

protection against over-pressurization.3

To adjust, rotate the APL valve.4

Adjust the APL valve: rotate the APL valveon the lower side of the enclosure to the desiredsetting. The APL valve is shown in the figure.



4.2.3.3 Setting FIO21

Adjust the dial on the medical gasblender: Turn the dial on the medical gasblender to the desired FIO2 setting

Check O2 sensor reading: Check the mon-itored reading of the O2 concentration onthe main monitoring and control page SSW:Note: Placeholder image

4.2.3.4 Accessing the settings menu for PCV or PSV2

The parameter settings for PCV and PSV modes can be accessed via the following instructions.3

These instructions begin at the main monitoring and controls page. For instructions on accessing4

this page immedatiately after turning the MVM on, see Chapter 4.2.2.5

Press the “Menu” button

Press the “Settings” button



Press the “Mode Settings” button

Press the tab corresponding to the de-sired mode: (to change:) Pressure-controlledventilation or Pressure-controlled ventilation

A view of the available settings for PCVmode

A view of the available settings for PSVmode

Optional: Press the “Load Presets” but-ton: loads preset values for all parameters



4.2.3.5 Setting Pinsp1

First, go to the page for PCV mode settings, following the above instructions.2

The “Insp. Pressure” parameter can beused to set Pinsp

Increment or decrement the value by 1using the + and − buttons

Click on the number for a quick display ofvalues

View of available options

4.2.3.6 Setting RR3

First, go to the page for PCV mode settings, following the above instructions.4



The “Respiratory Rate” parameter can beused to set RR

Increment or decrement the value by 1using the + and − buttons

Click on the number for a quick display ofvalues

View of available options



4.2.3.7 Setting I:E1

4.2.3.8 Setting Ptrig2

4.2.3.9 Setting Ftrig3

4.2.3.10 Setting Psupp4

4.2.3.11 Setting RRmin5

4.2.4 Special functions6

The following special functions can be performed automatically by the MVM:7

1. Inspiratory pause maneuver8

2. Expiratory pause maneuver9

4.2.4.1 Inspiratory hold maneuver10

The addition of this maneuver is under consideration11

4.2.4.2 Expiratory hold maneuver12

The addition of this maneuver is under consideration13

4.2.5 Set Alarm Thresholds14

SDA: Alarm list from ISO document. Full list in figure below15



Parameter Description Units

High airway pressure alarmcondition

Set the alarm limit for highpressure during respiratory cy-cle.

cmH2O or hPa

High FiO2 alarm condition Set the alarm limit for high in-spiratory oxygen condition:

percentage in volume of oxy-gen.

Low FiO2 alarm condition Set the alarm limit for low in-spiratory oxygen condition:

percentage in volume of oxy-gen.

SDA-GDA: These alarmsare clearly not possiblefor us, no CO2 sensorincluded so far. Highend expiratory CO2 alarmcondition

Set the alarm limit for highconcentration of CO2 condi-tion:

percentage in volume of CO2.

Low end expiratory CO2 alarmcondition

Set the alarm limit for low con-centration of CO2 condition: percentage in volume of CO2.

High respiratory rate alarmcondition

Set the alarm limit for high rateof respiratory breathing cyclesdelivered by the ventilator

breaths per minute

Low respiratory rate conditionSet the alarm limit for low rateof respiratory breathing cyclesdelivered by the ventilator

breaths per minute

Leak alarm condition Set alarm limit for high unin-tentional leak liters per minute or percent

Figure 4.3: Table of all alarms from ISO 80601-2-12 (2020)

4.2.6 Monitor and Respond to Warnings1



anne: From Patricia: 3. What ventilator parameters will be monitored? Eg: a. respiratory1

rate, inspiratory/expiratory ratio/times b. peak inspiratory pressure c. inspired2

oxygen concentration d. inspiratory flow rate e. expiratory volume - raw plus (calculated)3

compensation for compliance, that takes into account the compression of air at higher4

end-inspiratory pressures f. expiratory flow rate5

4.2.7 Graphics displays6

SSW: Don’t call these recordings, call them Graphics. Don’t bother with interpretation.7

4.2.7.1 Selecting Waveforms to Display8

To select the waveforms to display, navigate first to the “Alarm settings" menu:9

Click on the “Alarm settings” button

Select the parameter whose waveformyou wish to display

Select the position: Click the “Display Top”,“Display Middle”, or “Display Bottom” buttonto select whether the waveform of the selectedparameter will be display in the top, middle, orbottom row of the main graphics display.



Apply changes: Click the “Apply” button tomake the changes effective.

Click the “Back” button

Updated waveform display: The waveformof the selected parameter is now displayed inthe selected row of the main graphics area.

4.2.7.2 Freezing Waveforms1

To freeze the waveforms, navigate to the menu page described in Chapter 4.2.22

Freeze the waveforms: click on the “Freeze”button.



Frozen waveforms are displayed

4.2.7.2.1 Rescaling and shifting the axes using buttons1

Rescaling the horizontal axis: Use the 2buttons immediately to the right of the “Un-freeze” button to expand or shrink the hori-zontal scale simultaneously for all three wave-forms.

Shifting the horizontal axis: Press on theright (left) arrow button to shift horizontal axisto a higher (lower) range of values.

Rescaling the vertical axis: Use the 2 but-tons immediately to the right of the desiredwaveform to rescale the vertical axis for thatwaveform only.



Shifting the vertical axis: Use the up (down)arrow buttons to the right of the desired wave-form to shift the vertical axis to a higher(lower) range of values for that waveform only.

4.2.7.2.2 Shifting the axes interactively1

Shifting the horizontal axis interactively:Position your finger right below the horizon-tal axis of any waveform and drag to the right(left) to pan the axes of all waveforms simul-taneously to lower (higher) ranges.

Shifting the vertical axis interactively: Po-sition your finger to the left of the vertical axisof any waveform and drag up (down) to shiftthe axes to lower (higher) ranges for that wave-form only.

Simultaneously shifting the horizontal andvertical axes interactively: Position yourfinger in the main graphics region of any wave-form and drag it in 2 dimensions to shift thevertical scale of that waveform alone and thevertical axes of all waveforms simultaneously



4.2.7.2.3 Resetting the zoom and unfreezing the waveforms1

Resetting axis scales and postions: Pressthe “Reset zoom" button to reset the horizon-tal and vertical scales and positions of all wave-forms simultaneously.

Unfreeze: Press the “Unfreeze” button to re-store the display to the current active wave-forms.

4.2.7.3 Monitored parameters2

Diagrams showing how to access various pressure and flow waveforms in the database, and examples3

illustrating how to interpret them. We can also include formulas for calculating compliance and4

resistance (or if we calculate it for them, we can show how to find the calculations).5

4.2.8 Disconnecting a patient from the ventilator6

Basic procedure for disconnecting patient. Clean device and place into safe storage configuration.7

4.2.9 After Use8

See Section 6.2.9


Chapter 5: Patient safety 5–52

Chapter 51

Patient safety2

Contents3

4 5.1 Protective devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535

5.2 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 536

5.3 Rebooting MVM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5778910



5.1 Protective devices1

SSW: Make sure we include the emergency relief valve and emergency intake2

Severino & Stefano: Some sentences are to be checked with Software/Electronics Group3

and Physicians4

In the case of a power failure, the battery will automatically intervene and provide backup power5

for up to 120min and sound the buzzer. MVM is not suited for handling power outages lasting6

longer than this duration.7

An adjustable APL pressure relief valve on the inspiratory side of the MVM sets the maximum8

inspiratory pressure of the system, protecting the patient from excessive pressure. If necessary, a9

trained technician can adjust the pressure on this valve, as shown in section 4.2.3.2. SSW: Will10

this to be adjustable at all or will it be completely fixed?11

Bacterial/viral filters and a condensate trap are incorporated into the patient circuitry, to prevent12

the spread of breath-borne pathogens.13

Locks on the outside of the MVM prevent physical and GUI controls from being changed uninten-14

tionally.15

To protect the patient, alarms on the ventilator will alert medical staff to conditions that require16

attention. When an alarm goes off, the control panel displays a message, a buzzer issues an audible17

alert, and a high-luminosity LED provides a visible signal. While all alarms set the LED, some do18

not sound the buzzer.19

Alarms are also set to go off if monitored parameters of the patient exceed safe bounds.20

Set values for the alarms can be accessed through the control panel. Messages accompanying the21

alarms are shown on the control panel as well.22

These alarms are discussed in detail below. Suggested diagnostics for the alarms are discussed in23

Chapter 6.6.24

5.2 Alarms25

The possible alarms are listed below, along with a depiction of how they would appear on the control26

panel and a brief description. Alarms are divided into input and output categories. Output alarm27

parameters are listed in Chapter 1; in Table ?? for pressure-controlled ventilation (PCV) and in28

Table ?? for pressure-supported ventilation (PSV).29

anne: We need to identify and document: “the means by which an obstruction alarm30

condition is determined, and the means to test the obstruction alarm condition. Includes31

partial occlusion.” Should this test be done before each use? If so, include in op-prep32

chapter33



Input alarms—Related to the installation and performance of the MVM1

Electrical supply failure: The main powersupply to the MVM has been disrupted. Ifthe backup battery is engaged, it should beginproviding power to the device.

The green LED for POWER ON goesout. Slow audible signals are issued for 5min.

Battery low: The backup battery on theMVM is low on power and will soon shut down.

A warning will appear in the control panelSSW: what else?

Battery failure: The MVM is no longerreceiving power from the primary supply, andthe backup battery power supply has failed.

The green LED for POWER ON goesout. Slow audible signals are issued for 5min.

Battery status: The on-board backup bat-tery is no longer functioning at full capacityand should be replaced.

An LED flashes



Device temperature: The temperature ofthe MVM has exceeded its recommendedoperating range

An LED flashes

SSW: Will we have this alarm?

Oxygen level high/low: The O2 concentra-tion has fallen outside the specified range.SSW: My understanding is that wewill have an O2 sensor inside thedevice, before the outlet to thepatient circuit, so I removed theparts about adding sensors. Theyare preserved in comments below, ifneeded in the future.

The alarm is given as a buzzer signaland a visible flashing signal.

Gas supply failure: Insufficient flow iscoming from the inlet gas supply


SSW: Will we have this alarm?

Output alarms—Related to measured parameters of the patient1

High inspiratory pressure: The inlet airwaypressure exceeds the preset upper pressurelimit. When the alarm is activated, the MVMautomatically cycles to expiration. Severino& Stefano: The last sentence is tobe checked with Software/ElectronicsGroup and Physicians

This alarm consists of a buzzer and aflashing LED.



Low inspiratory pressure: The inlet airwaypressure has fallen below the preset lowerpressure limit.

This alarm consists of a buzzer and aflashing LED To be checked: Check this

High expiratory pressure: The outlet airwaypressure exceeds the preset upper pressurelimit.

This alarm consists of a buzzer and aflashing LED To be checked: Check this

Low expiratory pressure: The outletairway pressure has fallen below the presetlower pressure limit. When the alarm isactivated, expiration and/or pause in progressis immediately terminated and changedto inspiration. Severino & Stefano:The last sentence is to be checkedwith Software/Electronics Group andPhysicians


Low and high minute ventilation: Upperor lower alarm limit has been exceeded.There are two alarm limit settings:UPPER ALARM LIMIT: 2 L ·min−1

LOWER ALARM LIMIT: 20 L ·min−1 SSW:Are these fixed values?

The alarm is given as a buzzer signaland a visible flashing signal



Low and high tidal volume: The tidalvolume alarm is activated if the tidal volumeduring a respiratory cycle exceeds the upperor lower limit settings.LOWER ALARM LIMIT: 1500mLUPPER ALARM LIMIT: 50mL SSW: Arethese fixed values?


Low and high respiratory rate: The respi-ratory rate is out of range. This alarm is onlyavailable in Continous Mandatory Ventilationmode. The allowed range is 4 rpm to 50 rpm.SSW: Are these fixed values?


Low and high positive end expiratorypressure (PEEP): Upper or lower alarm limiton the PEEP has been exceeded. The allowedrange is 5 cmH2O to 20 cmH2O. SSW: Arethese fixed values?


Patient oxygen level high/low: The pa-tient’s oxygenation levels have fallen outsidethe specified range. SSW: Are these fixedvalues?


5.3 Rebooting MVM1

During a reboot, ventilation is inactive for less than 3 seconds. The MVM is configured to come2

back up with the same settings that were in place before the reboot, and will also resume ventilation3

automatically if it was ventilating before the reboot. Access to the control panel, however, will be4



unavailable for up to 45 seconds after a reboot, since the underlying microcomputer that controls1

the screen takes longer than the microcontroller that regulates the ventilation.2

There are three scenarios in which a reboot of the MVM is necessary: anne: from review3

report 4/54

• The internal micro-controller reboots but the main on-board computer remains on and both5

computers fail to re-establish connection: The “Communication Loss” alarm sounds and a6

message is displayed on the control panel.7

• The onboard computer reboots while the micro-controller remains on, and both computers8

fail to re-establish connection: An alarm sounds?9

• Both the onboard computer and the micro-controller reboot and settings are lost, ceasing10

ongoing ventilation: Alarm sounds and a message is displayed on the screen. If reboot was11

intentional, the alarm may be silenced.12

Instructions for rebooting the device are given below.13

Unlock power switch: Press the button tounlock the power switch.

Power down device: Press and hold thepower button for 5 s.



Power up device: Press and the power but-ton.

Reset the lock: Press the button to lock thepower switch back in place

Resume Ventilation: When the MVMpowers on, select “Resume Ventilation” toreload the most recent set of parameters andbegin ventilation in the last most recentlyused modeSSW: Does it actually automaticallyresume ventilation, or does it justreload parameters, and the usermust go through the steps to resumeventilation?

Severino & Stefano: \minuteVentilationSedatedTolerance must be set to 50 mL according1

to FCA approval document2

Instructions for checking and adjusting alarm parameters are given in Chapter 4.1.4.3


Chapter 6: Maintenance and troubleshooting 6–60

Chapter 61

Maintenance and troubleshooting2

ffigure3

Contents4

5 6.1 Routine Replacements And Maintenance . . . . . . . . . . . . . . . . . . . . 616

6.2 Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 637

6.2.1 Recommended cleaning solutions . . . . . . . . . . . . . . . . . . . . . . . 638

6.3 Full Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 689

6.4 Preparing for Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7310

6.5 Returning from Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7411

6.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7512

6.6.1 Minute Volume Too Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7513

6.6.2 Airway Pressure Out of Range . . . . . . . . . . . . . . . . . . . . . . . . 7614

6.6.3 Technical trouble — Power . . . . . . . . . . . . . . . . . . . . . . . . . . 7715

6.6.4 Technical trouble — Pressures . . . . . . . . . . . . . . . . . . . . . . . . 7716

6.6.5 Technical trouble — Minute volume . . . . . . . . . . . . . . . . . . . . . 7717

6.6.6 Technical trouble — Others . . . . . . . . . . . . . . . . . . . . . . . . . . 7718192021



6.1 Routine Replacements And Maintenance1

All maintenance should be performed by qualified service personnel at the recommended intervals.2

JH: Need to confirm this bill of materials to the actually selected components3

Single Use Components4

From April 14 mtg - this list should be relocated to a more appropriate section of the manual,or perhaps only in the technical manual (JH)

5

Operation of the MVM requires that the following components are replaced before connecting the6

ventilator to a new patient. For each component, the component listed in the bill of materials is7

given in parenthesis, or an equivalent component can be substituted.8

• SP-2 DP Flow Sensor (Envitec Spiroquant)9

• SM-1 HME Filter (Airlife 00-1851)10

• PV-2 (DEAS 04775-NS)11

• PV-5 (Laerdal 845240)12

• CT-1 (Intersurgical 1912000) JH: Remove?13

from MitchK pres 5Apr, fluidics sl 5 (anne)14

Maintenance Interval Components15

All maintenance activities should be recorded into the equipment log (see section 4.1.2).16

Lubrication17

• Use only oxygen-compatible lubricants (such as Tribolube-71, Krytox, or SLX-900)) for the18

cart/wheel assembly. Use as sparingly as possible, and remove all excess lubricant after19

application.20

• DO NOT use silicone based lubricants. Silicone vapors may cause damage to oxygen sensors.21

Maintenance Cautions• NEVER use oil or grease based lubricants with oxygen equipment.

22



Table 6.1: Maintenance Schedule

Frequency Component MaintenanceEvery 15 days Expiration filter SM-1 Replace after each patient and after each 15 days of con-

tinuous useEvery 6 months Entire ventilator Run extended self tests and verify alarm system is func-

tioning, as described in service manualEvery 6 months Oxygen and air mixer

filters SF-1 and 2Replace the air water trap/inlet filter and internal sinteredfilter - follow mixer manufacturer recommendations.

Every 6 months Oxygen sensor OS-1 Calibrate the oxygen sensor according to section 4.1.11.Every 6 months Touchscreen Inspect for damage. Replace screen protector if necessary

and re-calibrateYearly Entire ventilator Perform electrical safety test as described in service man-

ual. This includes validation of the safety grounding sys-tem, leakage, and over-current protection.

Yearly Entire ventilator Calibrate pressure and flow transducers. JH: Procedureto be developed

Yearly Ventilator cart Lubricate moving parts as required, following lubricationguidance below

Yearly Backup Battery Run discharge test (operate without AC power) - replacebattery if less than 30 minutes run-time JH: Differingvalues found in doc - 30 min vs 120 min

5 years Backup Battery Replace battery5 years Oxygen sensor OS-1 Replace every 60 months. JH: Per manufacturer data

sheet. Actual lifespan of oxygen sensor will depend uponoperating conditions - higher oxygen concentrations willshorten the life of the sensor. Calibrate the new sensoraccording to section 4.1.8.



6.2 Routine Cleaning1

Cleaning Cautions• A patient being treated by mechanical ventilation is highly vulnerable to the risks of infection. Dirty or contaminated

ventilator hardware is a potential source of infection.• Clean the ventilator prior to initial use, both before and after each patient use, and as may be required during operation.

When disinfecting contaminated parts, follow your institution’s hygiene protocol regarding the use of personal protectiveequipment (PPE). Handle all potentially contaminated materials as indicated by your local policies and procedures.

• The device utilizes components which must not be disposed of with ordinary waste. JH: These exist on the patient loop- TBD whether any internal components will fall into this category

• To avoid irreparable damage to the ventilator, do NOT attempt to sterilize it.• Avoid submerging the ventilator control unit in any manner, or pour or spray cleaning solutions over or into the ventilator.• Do not attempt to sterilize the ventilator’s internal components by exposing to ethylene oxide (EtO) gas. It can diffuse into

the components and pose a health danger.• Oxygen sensors used within the ventilator are sensitive to contamination by silicone vapours. Do not use silicone sealant or

lubricants on or around the ventilator.• This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do

not operate the ventilator in an MRI environment or in the vicinity of high-frequency surgical equipment or short-wavetherapy equipment. This device has not been tested for interference from nearby defibrillators. Electromagnetic interferencefrom nearby CRT-type monitors or TVs could disrupt the operation of the ventilator.

• If lubrication of hinges or cart mechanisms is required, use only oxygen-compatible lubricants. Never use oil or grease ofany kind with oxygen equipment.

• Do not use agents containing chloride compounds (ammonium chloride or sodium hypochlorite based), more than 2 percentglutaraldehyde, phenols, or abrasive cleaners. Some components are sensitive to organic solvents, and damage may not beimmediately apparent (brittle plastic).

• Cleaning agents must be used in accordance with the manufacturer’s product safety data sheet.• Avoid the use of pressurized air in cleaning the ventilator, to avoid aerosolizing potential contaminants. The use of HEPA

vacuums is acceptable to remove dust buildup within the enclosure or on the enclosure vent.2

To avoid risks to hospital staff and patients, disinfect and clean the device at the recommended3

intervals shown in Table 6.2. Always observe accepted hospital hygiene protocols.4

5

When the ventilator is being relocated to a new patient, the exterior of the unit6

should be cleaned PRIOR to removing it from its current location.7

8

It is not necessary to routinely clean the internal gas circuit within a ventilator between pa-9

tients, because the lines are not exposed to the patient or the patient’s respiratory secretions. The10

internals of the ventilator - with the exception of replacement of oxygen sensor OS-1 - are not11

meant to be repaired, cleaned, or maintained by the end user.12

13

Should patient secretions overwhelm expiration filter SM-1, or other contamination enter the unit,14

the ventilator should be removed from service until service from a qualified technician. Follow-15

ing recommended practices (keeping port caps and covers on until hoses need to be connected, and16

installing an expiration filter) should eliminate the need to clean the inside circuit of the ventilator.17

18

19

6.2.1 Recommended cleaning solutions20

• Soapy water or mild dish washing detergent solution (i.e. JoyTM or DawnTM)21

• Isopropyl alcohol or alcohol impregnated wipes (70% solution)22

• Hydrogen Peroxide (3% solution)23

• Accelerated hydrogen peroxide (AHP) wipes (but be aware that AHP wipes may cause pre-24



mature degradation of the LCD touchscreen and/or screen protectors)1

No Liquids! Liquid disinfectants must notbe sprayed our poured directly onto or intothe ventilator - especially the open ports(identified with arrows).

Avoid getting the unit wet to the pointwhere droplets begin to run. Apply all clean-ing solutions only with a dampened cloth orwipe.

Cleaning Definitions2

• Cleaning is done to remove obvious contamination, blood splatter, soil, or other foreign3

matter. It is usually accomplished by using water, a surfactant (mild dish washing soap or4

enzymatic product), and mechanical action. Failure to remove foreign material before disin-5

fection or sterilization will likely render those processes ineffective.6

7

• Disinfection is a chemical treatment done to kill the majority of bacteria and viruses.8

9

• Low-level disinfection (LLD) is suitable for components that meet Spaulding’s criteria for10

non-critical equipment or devices. This includes equipment that contacts only intact skin11

and not mucous membranes, and does not directly touch the patient.12

13

This definition includes the ventilator - but not the patient connection hoses. Low-level14

disinfection can be carried out only after first removing and cleaning all foreign material15

from the equipment.16

17

• High-level disinfection (HLD) is suitable for devices that come into contact with mucous18

membranes, but do not penetrate the vascular system (bloodstream). This applies to the19

patient circuit of the ventilator. To avoid having to perform HLD on the patient circuit,20

disposable items can be used once-per-patient and then discarded.21

22

As with low-level disinfection, all foreign material must first be removed. HLD is typi-23

cally carried out using chemical germicides or physical methods.24

25

• Sterilization is a physical or chemical process that results in the complete destruction or26

elimination of all microbial life, and is usually done by exposing the object to a high heat27

source. Most plastics used in respiratory therapy are not compatible with high-heat steril-28

ization techniques.29

30

Liquid chemical sterilization techniques may be compatible with respiratory equipment if31



they are not high-temperature compatible.1



Cleaning Sequence - Routine Cleaning1

The following steps are to be completed according to the cleaning schedule in Table 6.2.2

1. Assume that the ventilator is contaminatedwhen starting the cleaning and disinfectionprocess. Wash your hands or don appropriatepersonal protective equipment (PPE) as perlocal policy.

It is recommended to wear gloves andeye protection at a minimum.

2. If the ventilator is in operation, thetouchscreen MUST be changed into “clean-ing/maintenance” mode to avoid inadvertentlycontrolling the ventilator. JH: Steps onhow to force the touchscreen to mtcemode TBD

Cleaning of in-use units should be restrictedto a wipe-down of the exterior surfaces only!Do not disconnect hoses or power!

3. All surfaces should be cleaned with a softwipe or cloth dampened with an approvedcleaner/disinfectant. Obvious soil must beremoved prior to the final wipe.

Avoid the use of wipes that are satu-rated with fluid to the point of dripping. Becautious to ensure cleaning liquid does notenter the enclosure beside the touchscreenbezel.



4. Surfaces should be allowed 1 minute ofcontact time with the cleaning agent, andthen wiped dry with a clean cloth. If thecleaning agent evaporates without leaving anyresidue, then no further action is required.

To avoid residues when using some solu-tions, wiping with a clean cloth dampenedwith pure water may be required.

5. After cleaning is completed and theventilator is dry, the touchscreen should bereturned to normal operation mode.

JH: Steps on how to return thetouchscreen to regular operationalmode TBD.

6. If gloves were not worn during the cleaningprocess, it is recommended to wash yourhands at the completion of unit cleaning.

All disposable components and consumedcleaning supplies should be disposed of orrecycled according to local policy.



6.3 Full Cleaning1

Minimal surface “wipe downs” may be done with the power on (after changing the touchscreen2

to maintenance mode), but more thorough cleaning actions require the device to be powered down.3

4

A full cleaning can ONLY be done when the ventilator is powered down (not-in-use),5

and all of the power and hose connections are disconnected from the unit.6

Cleaning Cautions• Always assume that the ventilator is biologically contaminated when starting the cleaning and disinfection process.• Wash your hands or don appropriate personal protective equipment (PPE) as per local policy.• It is recommended to wear gloves and eye protection at a minimum while cleaning and disinfecting the ventilator.

7

Before Disassembling Ventilator Components8

• Power down the ventilator. Once powered down, remove the power connector from the control9

unit, and remove the AC plug from the wall outlet.10

• Shut off the oxygen and medical air valves, and allow any remaining pressure to drain from11

the input side of the ventilator.12

• Carefully remove the pressure lines from the ventilator, venting any remaining pressure.13

• Drain water traps and breathing circuit, being careful to direct any moisture AWAY from14

the ventilator.15

• Ensure all port caps, covers, and plugs are available for the ventilator orifices.16

Cleaning Cautions• To avoid potential microbial contamination, do not clean, disinfect, or re-use any single use or disposable components. Safely

dispose of these items as per local regulations.17



Cleaning Sequence - Full Cleaning1

1. Assume that the ventilator is contaminatedwhen starting the cleaning and disinfectionprocess. Wash your hands or don appropriatepersonal protective equipment (PPE) as perlocal policy.

It is recommended to wear gloves andeye protection at a minimum.

2. The exterior of the main ventilator controlunit is cleaned using the same procedure as insection 6.2 - Routine Cleaning.

3. JH: Internal cleaning requirementsof the ventilator are TBD. Verylikely no internal components willbe cleaned by the end user.

It is not necessary to routinely clean theinternal gas circuit within a ventilator betweenpatients, because the lines are not exposedto the patient or the patient’s respiratorysecretions. The internals of the ventilator- with the exception of replacement ofoxygen sensor OS-1 - are not meant to be re-paired, cleaned, or maintained by the end user.

Should patient secretions overwhelm ex-piration filter SM-1, or other contaminationenter the unit, the ventilator should beremoved from service until disinfected by aqualified technician. Following recommendedpractices (keeping port caps and covers on un-til hoses need to be connected, and installingan expiration filter) should eliminate the needto clean the inside circuit of the ventilator.



4. Carefully remove the control unit, and setaside. The cart unit can then be cleaned. Besure to clean the rear-side of the control unitbefore placing back on the cart.

5. All plugs, caps, and port covers should beremoved from the ventilator (if attached bytethers) and washed in a mild soap solution,rinsed clean, and dried thoroughly beforereattaching to the ventilator.

After washing and hand drying, let allparts air-dry completely.

6. Disposable and/or consumable items shouldbe replaced as per Table 6.2.

7. All disposable components and consumedcleaning supplies should be disposed of orrecycled according to local policy.

If gloves were not worn during the clean-ing process, it is recommended to wash yourhands at the completion of unit cleaning.



8. Reassemble the ventilator onto the cart,and install all port caps and covers.

Anne, from SM: We then needinstructions (again, with lotsof visuals) showing how to puteverything back together again.

9. Record the date of full cleaning into themaintenance log (see section 4.1.2). Local pol-icy may also require a "cleaning tag" be at-tached to the ventilator, indicating it is readyfor re-use or storage.



Table 6.2: Cleaning Methods and Schedules

Component Name CleaningInterval

Low-LevelDisinfection

High-LevelDisinfection

Ventilator enclosure(except for touchscreen)

Per Patient Wipe with solutions as persection 6.2.1

No

Touchscreen(either bare glass, or coveredwith a screen-protector)

Per Patientand Daily

Wipe with solutions as persection 6.2.1(AHP may cause degradation– use of a screen protector isrecommended)

No

Ventilator cart Per Patient Wipe with solutions as persection 6.2.1

No

Plugs and caps Per Patient Wash in mild soap solution,rinse with clean water, drythoroughly

No

Expiration Valve PV-2 DisposablePer Patient

No No

Adjustable Pressure LimitValve PV-3

Per Patient Wipe with solutions as persection 6.2.1

No

Negative-Pressure ReliefValve PV-4

DisposablePer Patient

No No

PEEP Valve PV-5 DisposablePer Patient

No No

Respiratory Circuit(one-time-use type)

DisposablePer Patient

No No

Patient Circuit Connectors(i.e. fittings, adapters,etc.) JH: Not sure ifthese are needed withdisposable patientcircuits

Per Patient No Clean and disinfect orsterilize following mfg’srecommended methods

Expiration Filter SM-1 DisposablePer PatientOR every 15days

No No

Gas Blender GB-1 TBD TBD TBDSintered Filters SF-1 & 2JH: Remove - and leavein mtce section only?

None - Re-place only -see Table 6.1

No No

Spirometer SP-2 DisposablePer Patient

No No



6.4 Preparing for Storage1

This ventilator is designed for emergency use only. It may need to be stored for a long period of2

time before being called into service again. There are a number of preparatory steps that will help3

to ensure the ventilator can be rapidly and reliably brought back into operation.4

1. If placing the unit into storage, double-check that all port covers and caps are securelyin place.

2. The built in battery must be preparedfor storage. JH: Long term storageconsiderations for battery need tobe defined here

3. Double-check that all port covers and capsare securely in place, and apply a clear plasticequipment cover over the ventilator to keep itclean in storage. Record the storage date onthe maintenance log (see section 4.1.2).

JH: Define environmental parametersfor storage - IE. temp/humidity/etc.



6.5 Returning from Storage1

After removing the ventilator from storage, follow these steps to return it to operation.2

1. Remove the protective covering, and ensureall port covers and plugs are still in place. Ifnot, the interior of the machine may be con-taminated, and not suitable to return to ser-vice.

2. Verify the oxygen sensor is still within itsusable lifespan (refer to Table 6.1), and replaceif necessary.

3. Reconnect the battery and perform run-time test. Replace battery if it is not within itsusable lifespan (refer to Table 6.1).

4. Calibrate the oxygen sensor (according tosection 4.1.8), as well as pressure and flowtransducers.

5. Perform a full cleaning of the unit.

6. Perform all regular startup performance val-idation tests. Record the back-in-service dateinto the maintenance log (see section 4.1.2).



6.6 Troubleshooting1

Severino & Stefano: What follows is a first draft2

6.6.1 Minute Volume Too Low3

Table 6.3: LOWER ALARM LIMIT for EXPIRED MINUTE VOLUME has activated an alarm

Cause Symptoms and diagnos-tics aids

Suggested treatments

Leakage between the trachealwall and tracheotomy tube orcannula

An air leakage may be de-tected by palpation or auscul-tation over the trachea.

Correct cuff pressure. If theleakage cannot be sealed, in-crease the PRESET INSP.MIN. VOL. so that expiredminute volume settles at asuitable level. Leakagesmainly occur during the in-spiration phase and the pauseat the end of inspiration whenthe pressure in the trachea ishigh. Prolonged inspirationtime.

Temporary increase of lungvolume.

Variations in measured ex-pired minute volume (sponta-neous breaths or sigh).

Ventilation obstruction, re-sulting in a pressure activatedinterruption of ventilation.

UPPER PRESS LIMIT forAIRWAY PRESSURE hasalso activated an alarm.

See UPPER PRESS LIMITfor AIRWAY PRESSURE.



6.6.2 Airway Pressure Out of Range1

Table 6.4: LOWER or UPPER PRESSURE LIMIT for AIRWAY PRESSURE has activated an alarm

Cause Symptoms and diagnos-tics aids

Suggested treatments

Too high: Airways obstruc-tions.

In cases of substantial ob-structions, recordings of flowand airway pressure indicateincreased airway resistance.Increased elastic resistance(low compliance) may alsooccur at the same time.When the UPPER PRESS.LIMIT for AIRWAY PRES-SURE is repeatedly exceededand, at the same time, ac-companied by interruptionsof inspiration, the expiredminute volume falls, and analarm is activated.

Too low: Patient triggers(attempts?) spontaneousbreaths.

The airway pressure (SIMVnot used) is usually negative(or under preset PEEP-level)only at the start of inspi-ration. Negative pressure(or pressure under presetPEEP-level) during thewhole inspiration indicatesa considerable deviationbetween preset minute vol-ume and the minute volumethe patient needs anne:clarify text after SIMVdecision

SIMV treatment normally.Patient triggering is more of-ten acceptable and suitable.Usually the patient requires alarger gas volume than thatsupplied by the controlledbreaths. In cases of unex-pected patient triggering, anincrease of preset minute vol-ume should be considered.



6.6.3 Technical trouble — Power1

Table 6.5: Ventilator does not start

Malfunction Possible cause ActionVentilator does not start Power cable not connected. Connect power cableGreen lamp goes out, ventila-tor stops, audible alarm.

No mains supply. Ventilate patient manually.

6.6.4 Technical trouble — Pressures2

Table 6.6: Pressure-related malfunctions

Malfunction Possible cause ActionWorking pressure varies. Pressure/flow from gas

source not enough. Fault ingas supply.

Low-pressure connection: in-crease gas volume/pressure.High-pressure connection:check gas source/mixer.

AIRWAY PRESSURE readingis 0.

Loose tube between inspi-ration channel and pressuretransducer

Attach the tube.

Accumulation of secretion. Suction of trachea.

6.6.5 Technical trouble — Minute volume3

Table 6.7: LOWER or UPPER ALARM LIMIT for EXPIRED MINUTE VOLUME has been activated

Malfunction Possible cause ActionLower Connection between patient

and ventilator has loosened.Reconnect the connections,e.g. Y-piece, trach. tube, pa-tient tube, water trap.

Upper Deeper breaths in VOL.CONTR. + SIGH, increasein expired minute volume(every hundredth breath).

Set the UPPER ALARMLIMIT somewhat higher.

6.6.6 Technical trouble — Others4

Anne: We’ll fix pagination at the end5



Table 6.8: O2 cell

Malfunction Possible cause ActionNo digital display O2 cell not inserted; or

CONC. % is selected.Insert an O2 cell


Chapter 7: Technical information 7–79

Chapter 71

Technical information2

Contents3

4 7.1 Accuracy of the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . 805

7.2 Component List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 816

7.3 Components Included in the Package but External to MVM . . . . . . . . . 817

7.4 Connection to mains and battery operation . . . . . . . . . . . . . . . . . . . 828

7.5 Contents of the Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . 829101112



7.1 Accuracy of the instrument1

Walter: this will be populated once tesst at ELEMASTER will be over2



7.2 Component List1

The components are as follows:2

anne: add a figure with number labels so that we can number the components in the3

list accordingly4

1. Connection to oxygen and air supply: at the left-hand side, the MVM is connected to5

a pressurized oxygen/air line.6

2. Sintered filters SF-1,SF-2 The sintered filters remove particulate in the inline that can7

clog the pipes.8

3. GB-1 (Gas Blender): The oxygen and air flow are mixed in a medical GB-1 (Gas Blender)9

device.10

4. Air/Oxygen delivery proportional valve PV-1: The incoming gas flow to the patient11

is controlled by the proportional valve PV-1 using a process control loop based on the value12

of PS-1 that ensures the proper respiratory minute volume is delivered to the patient;13

5. Adjustable Pressure limit APL valve PV-3: Mechanical valve that sets the value of14

the maximum inspiratory pressure in the range 20 cmH2O to 30 cmH2O15

6. Negative Pressure Relief valve PV-4: A check valve to avoid any negative pressures16

when the patient is in active mode and demands more air. As long as there is a positive17

pressure in the respiratory lines this valve remains closed. A bacterial/viral filter may be18

required just before the valve to prevent contaminated room area entering the upstream part19

of the system.20

7. Oxygen sensor O2S-1: An optional oxygen sensor O2S-1 can be used to measure contin-21

uously the fraction of inspired oxygen FiO2.22

8. Spirometer SP-1: An optional digital spirometer can be connected to the input line to23

monitor the inspiratory flow rate.24

9. Breathing system: The breathing system, connected to the tracheal tube, supports the25

attachment of two plastic tubes of standard size 22mm connecting respectively to valves26

PV-1 and PV-2, and to a smaller plastic tube leading to four differential pressure sensors27

PS-1, PS-2, PS-3 and PS-4 to monitor pressure and flow. The standard for connection of the28

breathing system is the 22mm cone and socket combination defined in the standard [2].29

10. Condensate trap CT-1: The expiration tube passes through a condensate trap allowing30

for removal of condensed vapor from the patient’s breath.31

11. HME bacterial/viral filter SM-1: The silicone membrane obstructs access to the machine32

of the wet flow.33

12. Expiration valve PV-2: High throughput valve controls the expiratory flow. An adequate34

orifice diameter guarantees the flow corresponding to the expiration of a proper respiratory35

minute volume at the given PEEP values.36

13. PEEP Valve PV-5: A mechanical valve that controls the positive end-expiratory pressure37

in the range 5-20 cmH2O. PV-5 controls the PEEP pressure.38

7.3 Components Included in the Package but External to MVM39

anne: the following from mitch 4/5Manually Adjustable Flow Control Valves Separate from40

Ventilator41



• Check Valves (SWAGELOK B-4CP2-1-SC11)1

• Sintered Metal 1 um Filters (source tbd)2

• GB-1 (Gas Blender) (source tbd)3

7.4 Connection to mains and battery operation4

anne: from Amaudruz 4/55

The MVM equipment is to be electrically powered by conventional/UPS power source from the6

care unit facility (standard international voltages ∼100V-240V 50/60Hz). The main power switch7

(On/Off) acts solely on the AC line power and is to be lockable/securable to prevent inadvertent8

operation. A separate module containing the AC-DC converter provides the necessary power9

(DC12V at 2A) to all the components of the MVM device. In addition, this module hosts a10

power backup unit (UPS) to extend operation of the MVM up to 30 minutes in situation of11

power loss or during patient transport. Detection and report of battery operation with audible12

signal and visual indicator is foreseen. The DC voltage is delivered to the main MVM enclosure13

energizing all its components such as the main electronics processors, display device, pressure14

sensors and electro-mechanical devices (valves). The audible and visual indicator are reporting a15

well defined set of Alarm and Warning conditions detected during the device control loop operation16

(Section 5.2). Cancellation/acknowledgment of the those special conditions is done by human17

intervention on either: a) on the MVM front panel through a “reset” button, or b) by human18

correction of the problem, removing automatically the Warning or Alarm condition. System status19

and warning are to be reported to either the display or audible and visual indicator regarding20

internal communication, processor issues, temperature issues.21

7.5 Contents of the Technical Manual22

anne: required per Jen’s ISO reqs document. Also: Where appropriate, provide a cross-reference23

(throughout this manual, I think) to the additional information available in the technical24

description.25


Glossary 7–83

Glossary1

APL adjustable pressure relief. 18, 402

CAD computer aided design. 303

cart the stand that the MVM attaches to and rests upon. 6, 9, 28, 29, 714

control panel Control panel for the MVM. It uses touch-screen technology. 18–21, 24, 53, 54, 57,5

586

trigger flow (Ftrig) the percent flow relative to the peak flow at which the expiratory cycle will be7

triggered by the patient in pressure-supported ventilation (PSV) mode. ii, 39, 458

Fraction of Inspired Oxygen (FIO2) the relative oxygen concentration of the air in the inspira-9

tory leg of the circuit. ii, 10, 14, 16, 18, 39, 4110

I:E The ratio of inspiratory time over expiratory time. ii, 6, 13, 20, 39, 4511

Expiratory Volume per minute (MVe) Needs definition. 21, 24, 2512

MVM Mechanical Ventilator Milano. ii, iv, 3, 7–10, 13, 15, 16, 18–22, 27, 28, 30, 31, 33–35,13

39–41, 45, 53–55, 59, 61, 82–8414

inspiratory pressure (Pinsp) the set pressure to supply the patient during the inspiratory cycle of15

pressure-controlled ventilation (PCV). ii, 13, 15, 21, 22, 24, 25, 39, 4316

support pressure (Psupp) the set amount of pressure to apply in support of a patient-triggered17

breath in PSV. ii, 39, 4518

trigger pressure (Ptrig) pressure threshold for initiating the inspiratory threshold in patient-triggered19

breaths in PSV mode. ii, 39, 4520

pressure-controlled ventilation (PCV) used for patient who is not breathing on their own; MVM21

supports this mode; (extra from Laurent:) For pressure-controlled you need to monitor22

the volumes delivered and/or exhaled. You can also add the same pause and give the23

plateau but it is not mandatory since peak and plateau are often very close.. ii, iv, v,24

13–15, 20, 22, 37–39, 41–43, 53, 83, 84, 8825

positive end expiratory pressure (PEEP) the positive pressure that will remain in the airways at26

the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric27

pressure in mechanically ventilated patients; it is also the pressure at the beginning of28

the next inspiration. ii, 10, 13–16, 18, 39, 40, 5729

pressure-supported ventilation (PSV) a typical assisted mode: a variation of PCV on two as-30

pects: 1) its is always triggered by patient signal (no triggering on time or only for31

back up in case of apnea). 2) it is cycled based on flow and not on time; the flow is32

decelerating in pressure targeted modes (i.e., pressure control and pressure support),33


Glossary 7–84

and a fixed percentage like 30% of the peak flow is detected to cycle to expiration...1

When the patient inspires, creating a negative (subatmospheric) pressure in the air-2

ways, the ventilator “assists” the patient simply by keeping the pressure constant, i.e,3

by increasing the flow. (So a controller needs to keep the pressure constant at the4

airway opening whatever the pressure downstream.) The pressure is constant with5

or without active inspiration from the patient, but the flow and the delivered volume6

change; supported by MVM?. ii, iv, 15, 16, 20, 22, 23, 37, 39, 41, 42, 53, 83, 84, 88,7

898

respiratory rate (RR) the number of breaths taken by the patient per minute, either fixed by a9

time trigger in PCV mode or measured from the rate of patient-triggered breaths in10

PSV mode. ii, 13, 20, 22, 39, 43, 4411

minimum respiratory rate (RRmin) if a patient does not initiate a breath within the time window12

defined by this parameter, the MVM will issue an apnea alarm and switch to PCV13

mode. ii, 39, 4514

tidal volume (Vt) The lung volume representing the normal volume of air displaced between15

normal inhalation and exhalation when extra effort is not applied. 13, 21, 24, 2516


REFERENCES –85

References1

[1] DOE Office of High Energy Physics, “Mission Need Statement for a Long-Baseline Neutrino2

Experiment (LBNE),” tech. rep., DOE, 2009. LBNE-doc-6259.3

[2] International Organization for Standardization, “ISO 5356-1:2015,” 2015.4

https://www.iso.org/standard/54851.html.5


https://www.iso.org/standard/54851.html

Chapter A: Technical Diagrams for Ventilation Modes A–86

Appendix A1

Technical Diagrams for Ventilation Modes2

The MVM is setup to work with two different modes of ventilation: Pressure Controlled Ventilation3

(PCV) and Pressure Supported Ventilation (PCV). For a better understanding of the operation4

modes it is first needed to explain the basic structure of the MVM.5

A.1 Device structure6

The illustration in Fig. A.1 shows the MVM ventilator (components within the light blue box)7

and a possible setup for the corresponding breathing circuit. The main components are described8

below:9

Connection to oxygen and air supply: at the left-hand side, the MVM is connected to a pres-10

surized oxygen/air line;11

Sintered filters SF-1, SF-2 the sintered filters remove particulate in the inline that can clog the12

pipes;13

Gas blender GB-1 The oxygen and air flow are mixed in a medical gas blender. GB-1 is external14

to the MVM unit. The FiO2 set point is set manually, directly on the GB-1 unit.15

Differential pressure sensors: Four differential pressure sensors PS-1, PS-2, PS-3, and PS-4 mon-16

itor the pressure and flow at different points of the breathing system. PS-1 measures17

the pressure drop across a small aperture section of tube near the patient and thus18

the flow rate. PS-2 and PS-3 are used as inputs to the pressure control loop, and PS-419

measures the pressure in the expiratory line from the patient.20

Air/Oxygen delivery proportional valve PV-1: The incoming gas flow to the patient is controlled21

by the proportional valve PV-1 using a process control loop based on the values of22

PS-2| and PS-3 to ensure that the proper respiratory pressure is delivered. PV-1 is a23

normally close (NC) valve;24

Adjustable pressure limiting valve PV-3: Mechanical valve that sets the value of the maximum25

inspiratory pressure in the range 20 cmH2O to 80 cmH2O;26

Negative pressure relief valve PV-4: A check valve to avoid any negative pressures during pa-27

tient assisted ventilation. In that mode, the patient is active and can spontaneously28

request more air. As long as there is a positive pressure in the respiratory lines this29



Air APL Valve20-80 cm H2O

NegativePressureRelief

PV-3

PS-1

O2

PEEP Valve

PV-5

PV-4

SP-1

5-20 cm H2O

PS-2

SM-1SP-2

CT-1

To Patient

S-1 S-4

NO

PS-5

PS-6

Integrated Check Valves

April 10 202014:26 CEST

VentSF-1

SF-23.4-6.0 bar

PV-2

NC

CLK

Mechanical Ventilator Milano IllustrationGB-1

PV-6PR-1

Figure A.1: Illustration of the MVM ventilator and possible breathing circuit.

valve remains closed. A bacterial/viral filter may be required just before the valve to1

prevent contaminated room air entering the upstream part of the system;2

Oxygen sensor OS-1: An oxygen sensor OS-1 is used to continuously monitor the fraction of3

inspired oxygen FiO2;4

Spirometer SP-1: A precision spirometer is connected to the input line to monitor the inspiratory5

flow rate;6

Breathing system: The breathing system, connected to the tracheal tube, supports the attach-7

ment of two plastic tubes of standard size 22mm connecting respectively to valves8

PV-1 and PV-2, and to a smaller plastic tube leading to the differential pressure9

sensors PS-1, PS-2, PS-3, and PS-4 to monitor pressure and flow. The standard for10

connection of the breathing system is the 22mm cone and socket combination defined11

in the standard [2];12

Condensate trap CT-1: The expiration tube passes through a condensate trap allowing for re-13

moval of condensed vapor from the patient’s breath;14

Silicone membrane SM-1: The silicone membrane filters access to the machine of the wet flow;15

Expiration valve PV-2: This high throughput valve with low pressure-drop controls the expira-16

tory flow. An adequate orifice diameter guarantees the flow corresponding to the17

expiration of a proper respiratory minute volume at the given PEEP values; the valve18

is controlled by the three-way solenoid valve PV-6.19

PEEP valve PV-5: A mechanical valve that controls and defines the positive end-expiratory pres-20



sure PEEP in the range 5 cmH2O to 20 cmH2O.1

A.2 Pressure Controlled Ventilation (PCV)2

The function chart for pressure-controlled ventilation (PCV) mode is shown in Figure A.4. A3

legend for how to read the function chart can be found in Appendix4

In pressure-controlled ventilation (PCV) mode, the state machine loops indefinitely, monitoring5

the pressures at four points in the system (PS-1, PS-2, PS-3, and PS-4) on a 200 Hz clock, and6

adjusting the valves PV-1 and PV-2 as necessary depending on the stage of the breath cycle. The7

operator sets the target inspiratory pressure, and the breathing cycle is defined by the operator-8

set values of inspiratory time and respiratory rate. For patient safety, the maximum inspiratory9

pressure threshold is manually set with the PV-3 valve. If the patient takes a spontaneous breath10

(detected by a sudden change in the value of PS-2), the cycle timer resets to avoid breath stacking.11

Pressure Controlled Ventilation (PCV)

START

BreathingMode = PCV

Update ParamsReset SP-1, SP-2 totalizersReset Timer1Close PV-2Open PV-1

Active control of PV-1 based on PS-2, Ptarget

Integrate Inspiration Volume (SP-1 and SP-2)

Close PV-1

Write Inspiration Tidal Volumes (SP-1 and SP-2)

Inspiration

Timer1 > InspirationTime

Reset SP-2 totalizerOpen PV-2

Integrate Expiration Volume (SP-2)

Close PV-2Write PEEP (PS-2)Write Exp Tidal Volume (SP-2)

Expiration

ExpiratoryPause

Timer1 > BreathingPeriod OR PatientBreathDetected = TRUE

ExpiratoryPause = FALSE

Jump to START

InspiratoryPause

InspiratoryPause = FALSE

PS-2 > PS2Max

Figure A.2: Function-chart for PCV mode

A.3 Pressure Supported Ventilation (PSV)12

The function chart for pressure-supported ventilation (PSV) mode is shown in Figure A.3.13



In pressure-supported ventilation (PSV) mode, the inspiration is triggered by the patient (detected1

by a sudden change in the value of PS-2). An apnea trigger is included in PSV mode to prevent2

missing breaths. If the patient fails to initiate a breath within the operator-set ApneaPeriod, the3

device will revert to PCV mode and force a breath. The inspiration is ended when the inspiratory4

flow rate of the breath in that cycle (measured on SP-2) falls to some fraction of the maximum5

inspiratory flow, typically 30%.6

In both modes, the inspiratory and expiratory pauses are optional, only occurring during the time7

that the operator is touching the button on the control panel.8

Pressure Supported Ventilation (PSV)

START

BreathingMode = PSV

Update ParamsReset SP-1, SP-2 totalizersReset Timer1Reset MaxFlowClose PV-2Open PV-1

Active control of PV-1 based on PS-2, PtargetIntegrate Inspiration Volume (SP-1 and SP-2)Track MaxFlow (SP-2)

Close PV-1

Write Inspiration Tidal Volumes (SP-1 and SP-2)

Inspiration

SP-2 < MaxFlow * ExhaleTrigger OR Timer1 > InspirationTime * 1.2

Reset SP-2 totalizerOpen PV-2

Integrate Expiration Volume (SP-2)

Close PV-2Write PEEP (PS-2)Write Exp Tidal Volume (SP-2)

Expiration

ExpiratoryPause

PatientBreathDetected = TRUE


Jump to START

InspiratoryPause

InspiratoryPause = FALSE

PS-2 > PS2Max

Timer1 > ApneaPeriod

Set BreathingMode to PCV

ExpiratoryPause and Mode Switch


Figure A.3: Function-chart for PSV mode



A.4 Function chart legenda1

Sequential Function Chart Key

START

Transition Condition

Entry Action Maintain Action Exit

Action Step 1 Name

Transition Condition Transition Condition


Action Step 2 Name


Action Step 3 Name



Jump to START

Italics: User-set parameter

Bold: I/O (sensors, valves, buttons)

BoldItalics: Function of both I/O and parameters

Figure A.4: Function-chart legenda


Chapter B: Regulatory agencies approval documents B–91

Appendix B1

Regulatory agencies approval documents2


Chapter C: Symbols and Labeling 7–92

Appendix C1

Symbols and Labeling2

3



Figure C.1: Labels typically found on equipment. Courtesy: Elemaster™ [].



Figure C.2: Labels typically found on GUI or unit. Courtesy: Covidien Puritan Bennett™ [].

Figure C.3: Labels typically found rear of unit. Courtesy: Covidien Puritan Bennett™ [].



Figure C.4: Shipping carton labels. Courtesy: Covidien Puritan Bennett™ [].


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Mechanical Ventilator Milano (MVM) DRAFT User Manual

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