MVM Ventilator

Mechanical Ventilator Milano (MVM)

A mechanical ventilator designed in response to the COVID-19 pandemic.

Courtesy of WHO Compendium 2021

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

The MVM Ventilator is a mechanical invasive ventilator that was designed for mass production in response to the COVID-19 pandemic. The ventilator is nearing the end of its prototyping and testing phase as of 2020 and the manufacturer has plans to deliver 10,000 ventilators to Canada in 2021.

This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.

Target region(s) Target region for distribution/implementation (listed by country if specified)

Worldwide

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

As of 2020, Vexos and the Government of Canada

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

6000 USD for the product, 60 USD for consumables, 600 USD for accessories

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Rapidly designed, mechanical ventilators

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Trained healthcare workers

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

MVM Ventilators are manufactured by Vexos Inc., an international electronics manufacturing company that has facilities in the United States, Canada, China, and Vietnam.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Licensed under the CERN-OHL-S v2 Open Hardware

User Provision Model Where can the product be purchased/acquired by end users?

Direct sales to governments and hospitals

Distribution to date Number of units that have been deployed, downloads or users to date

None as of 2020, but a contract has been signed to provide 10,000 units to the Canadian government.

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Use case (category and target population)

Type of ventilator as defined by WHO specifications and the patient group that can use the device as specified by the manufacturer (weight in kg if specified).

Intensive Care; adult (> 40 kg)

Ventilation modes

PCV, PSV

Internal PEEP capability and range

No (External Disposable PEEP Valve)

Range pressure setting

2-50 cmH2O

Peak pressure limitation

Yes

FiO2 settings

Adjustable, External, Measured

Inspiratory/expiratory pause maneuver

Yes

Primary display modes

Does the ventilator display PEEP, Peak Pressure, Tidal Volume, Ventilator Mode Indicatory Status?

Peak pressure, tidal volume, ventilator mode status

Spirometry available

Yes

Capnography available

Main alarms available

Are the following main alarms available: High/low FiO, high/low minute volume (MV), high/low inspiratory pressure, breathing circuit disconnect, apnoea, gas supply failure, power failure, low battery?

Yes

Air source, O2 low pressure capability

Is the air source external or internal? If internal, what technology is used to provide the air source? Does the ventilator have O2 low pressure capability?

External, No

Internal or external battery (operating time, recharging time)

Internal (2 hours, 24 hours)

Power requirements (W)

60 W

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

The MVM ventilator is inspired by the Manley ventilator, which was developed by Roger Manley in 1961. The ventilator includes the following main components: Connection to oxygen and air supply, sintered filters, gas blender, four differential pressure sensors, air/oxygen delivery proportional valve, adjustable pressure limiting valve, negative pressure relief valve, oxygen sensor, spirometer, braking system (connected to the tracheal tube), condensate trap, silicone membrane filter, expiration valve, and PEEP valve.

The control system regulates the air/oxygen delivery proportional valve and the expiration valve based on the selected programmed respiratory cycle.

The following accessories are needed: Gas blender (GENTEC GMX120 or equivalent) and catheter mount (DEAS 1510TG, DEAS 22xxDV, or equivalent).

The control system regulates the air/oxygen delivery proportional valve and the expiration valve based on the selected programmed respiratory cycle.

Product schematics Design and assembly illustrations

Figure provided by Mechanical Ventilator Milano

Technical support Technical support provided by

Support is available through the manufacturer.

Replacement components Availability of replacement components (in-country, by order,...)

Replacement components are available from the manufacturer.

Lifecycle Disposal and warranty

5-10 years

Manufacturer specified performance targets Designer / Manufacturer specified targets

The MVM ventilator was designed in response to the COVID-19 pandemic and thus the designers focused on the following targets: (1) Small number of components, (2) ease of procurement, (3) simplicity of construction, (4) low cost, (5) convenience of deployment, (6) customizability, (7) reliability, and (8) limited oxygen consumption.

Vetted performance Findings of manufacturer evaluations or independent testing centers

The ventilator has passed all of the ISO 60601 tests for basic safety and essential performance.

Testing organizations Independent lab, academic research centers, etc.

Testing has been conducted in partnership with the Medicine Department of Milano Bicocca University.

Safety Potential hazards / risks related to operation of this product

For safety, the manufacturer specifies the following operational ranges: Temperatures from 10 to 40 degrees Celsius, and in relative humidities from 10-95%, at a maximum altitude of 3000 meters.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

The manufacturer offers additional accessories, including a gas blender for mixing medical air and oxygen before the inlet to the mechanical ventilator.

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

None

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

The device was designed under the MHRA Rapidly Manufactured Ventilator System guidelines and has received approval from Health Canada as well as initial approval from the U.S. FDA, as of 2020.

The mechanical ventilator conforms to ISO 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, ISO 80601-2-80, ISO 10993, ISO 18562-1,2,3.

The manufacturer plans to certify the software according to standard EN 62304.

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

Performance testing was carried out as specified by the ISO 80601-2-12:2020 Testing Protocol and a usability check has been performed according to standard EN 62366.

Other information