FreeCAD-library/Medical Parts/01 Biomedical/OpenLung

Disclaimer

The plans, documents and other materials (“Material”) contained on this website are intended to facilitate the design of a prototype reproducible medical device to be used if required during the Covid-19 pandemic. The Material is not itself a medical device. The Material has not been tested and has not been approved for use in humans or animals by any regulatory authority of any country.

By using the Material, you are agreeing to the following disclaimer.

OpenLung / Open Source Ventilator offers the Material as-is and as-available, and makes no representations or warranties of any kind whatever concerning the Material, whether express, implied, statutory, or other. This includes, without limitation, warranties of merchantability, fitness for a particular purpose, non-infringement, absence of latent or other defects, accuracy, or the presence or absence of errors, whether or not known or discoverable.

To the extent possible, in no event will OpenLung / Open Source Ventilator be liable to you on any legal theory (including, without limitation, negligence) or otherwise for any direct, special, indirect, incidental, consequential, punitive, exemplary, or other losses, costs, expenses, or damages arising out of the Material or use of the Material, even if OpenLung / Open Source Ventilator has been advised of the possibility of such losses, costs, expenses, or damages.

Any ventilator system that has not been approved by a competent medical device regulatory authority may not deliver to the user the ability to properly monitor and control tidal volume, inspiratory pressure, inspiratory: expiratory ratio, heart rate, nor provide the user with the ability to monitor and control positive-end expiratory pressure (PEEP), peak inspiratory pressure (PIP) or to adapt to individual patient requirements. Inability to monitor and/or control any of these factors can cause death or serious permanent injury.

The disclaimer of warranties and limitation of liability provided above shall be interpreted in a manner that, to the extent possible, most closely approximates an absolute disclaimer and waiver of all liability.

Low Resource Bag Valve Mask (BVM) Ventilator

The OpenLung Emergency Medical Ventilator (OEMV) is a stopgap solution to the global shortage of medical ventilators. Its rapid development is the result of a novel open source paradigm that allows team members to make real-time contributions from any place in the world. DevOps is overseen by a cabal of professionals whom separate the wheat from the chaff and direct the collective effort. The device itself is composed of widely available materials and put together via simple fabrication processes. Electrical components and software have also been developed, these allow basic parameters and controls to be set by clinicians. Physical working prototypes have been built and testing toward a final product is well underway. The OEMV is an open piece of technology that can be manufactured and deployed anywhere in the world.

Design Requirements

Project Requirements are listed here.

Contributing to the project

OpenLung as implied by the name has maintained a high degree of openness to new contributors. In fact, we have created a wiki called Contributing for this purpose

Design

The OpenLung project has managed to bring together many experts and ideas into a cohesive remote work environment. We believe our processes are unique and efficient for the future of remote group design work. In fact, we have attempted to compile what we have learned in the Design Wiki Additionally there are discipline specific Wikis for Electronics and Mechanical. Our designs require parameters, suggestions and direction of the medical community, some of those notes are compiled in Medical Notes

Documentation

A major factor in the success of this open source project is having extensive, clear and accessible documentation. Though we here at OpenLung see room for improvements, we would like to share our documentation process including what we have learned, examples we like and methods we use. Documentation Wiki

Fabrication

Despite OpenLung not being a manufacturer, this project designs for manufacturability. In fact, we have labored over the consideration of variability in production processes and supply chains. Detailed information regarding fabrication -- as it relates to this project -- is stored on the 'Fabrication' page

Testing

Evaluating the performance of our designs require extensive testing and data collection. Testing is done using specialized equipment that is discussed in further detail within the Testing Wiki

Distribution

The logistics of providing designs for decentralized ad-hoc manufacturing operations is interesting and complex. That is why we created a whole Wiki Page dedicated to this

Project Teams

Team	Directory	Issue Label
Requirements	requirements	~"Requirements"
Mechanical Concepts	mechanical-concepts	~"Mechanical Concepts"
Control Electronics	control-electronics	~"Control Electronics" ~"Controller Software"
Sensor Layout and Specifications	control-electronics	~"Sensor Hardware"
Housing Concepts	housing-concepts	~"Housing Concepts"
Humidifier Concepts	humidifier-concepts	~"Humidifier Concepts"
BVM Filtration	bvm-filtration	~"BVM Filtration"
Regulatory	regulatory	~"Regulatory"
Testing	testing	~"Testing"

This document in other languages:

		Language	Translations
english	català	čeština	deutsch	español	français
日本語	nederlands	polski	português	Română	Русский
svenska	türkçe	汉语	漢語	عربى	---

Contribute by translating this ReadMe.md file into other languages here.

Image Licensing

Except where otherwise noted, image content on this repository is licenced under a Creative Commons Attribution-ShareAlike 4.0 International License.

Repository managed by OpenLung and OS Ventilator Ireland Communities