Updated on March 8, 2024

·

Created on August 31, 2021

MVM Ventilator

Upcoming Update

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

Tested By
  • University of Milano Bicocca
Content Partners
Unknown

Author

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 SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$6,000.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

As of 2020, Vexos and the Government of Canada

Competitive Landscape

Direct competitors include Impala Ventilator and CERN HEV Ventilator.

Manufacturing/Building Method

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

Intellectural Property Type

Select Type

User Provision Model

Direct sales to governments and hospitals

Distributions to Date Status

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

Use case (category and target population)

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

Peak pressure, tidal volume, ventilator mode status

Spirometry available

Yes

Capnography available

No

Main alarms available

Yes

Air source, 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

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

Technical Support

Support is available through the manufacturer.

Replacement Components

Replacement components are available from the manufacturer.

Lifecycle

5-10 years

Manufacturer Specified Performance Parameters

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 Status

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

Safety

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

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

Compliance with regulations

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

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

None

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