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*'''Pressure support ventilation (PSV):''' when a patient has trouble completing a breath thus resulting in negative pressure during a breathing circuit | *'''Pressure support ventilation (PSV):''' when a patient has trouble completing a breath thus resulting in negative pressure during a breathing circuit | ||
*'''Assist Control (AC):''' used when a patient needs support for every breath | *'''Assist Control (AC):''' used when a patient needs support for every breath | ||
* Confirm that the peak inspiratory pressure (PIP), respiratory rate (RR), positive end expiratory pressure (PEEP), inspiratroy:expiratory ration (i:e), and tidal volume (TV) are accurate by using the Michigan Instruments software package that accompanies the lung. | * Confirm that the peak inspiratory pressure (PIP), respiratory rate (RR), positive end expiratory pressure (PEEP), inspiratroy:expiratory ration (i:e), and tidal volume (TV) are accurate by using the Michigan Instruments software package that accompanies the lung (downloaded in the MI USB drive). | ||
* Test the alarms by unplugging the machine, wiring, and appropriate tubing. The accessories that should be tested are: | * Test the alarms by unplugging the machine, wiring, and appropriate tubing. The accessories that should be tested are: | ||
*'''Low Pressure Alarm:''' Decrease the PIP value using the ventilators user interface to an abnormal value. | *'''Low Pressure Alarm:''' Decrease the PIP value using the ventilators user interface to an abnormal value. | ||
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*'''Oxygen Tube Disconnection Alarm:''' Unplug the oxygen intake tube from the ventilator while the machine is on. | *'''Oxygen Tube Disconnection Alarm:''' Unplug the oxygen intake tube from the ventilator while the machine is on. | ||
*'''Mechanical Failure/Fatigue (# of cycles):''' Leave the machine running for extended periods of time (a few hours, days, weeks) and observe any inaccuracies. | |||
*Ideal Values that Should be Targeted for a Healthy Patient: | *Ideal Values that Should be Targeted for a Healthy Patient: | ||
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*'''FiO2:''' 1.0 (100%) | *'''FiO2:''' 1.0 (100%) | ||
* Mechanical | * '''Mechanical Failure/Fatigue (# of cycles):''' ideally for as long as the patient requires the use of the ventilation | ||
===Regulations=== | ===Regulations=== | ||
* | * FDA's activities regarding medical devices: https://www.fda.gov/medical-devices | ||
* | *COVID-19 activities: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders | ||
* Policy for ventilators: https://www.fda.gov/media/136318/download | |||
* Emergency Use Authorization: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization | |||
* A ventilator would fall under other medical devices: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidothermeddev | |||
===Safety Precautions=== | ===Safety Precautions=== | ||
* Confirm that the wiring in the ventilator is correctly set-up (see wiring diagram) | * Confirm that the wiring in the ventilator is correctly set-up (see wiring diagram) | ||
* Make sure that the ventilator is properly connected to the artificial lung with the proper adapter size (see picture below) | * Make sure that the ventilator is properly connected to the artificial lung with the proper adapter size (see picture below) | ||
* Confirm that the artificial lung is set-up correctly BEFORE turning the machine on (see manual below, pg.#) | * Confirm that the artificial lung is set-up correctly BEFORE turning the machine on (see manual below, pg.#) | ||
==See also== | ==See also== | ||
Revision as of 19:02, 2 April 2020
Over the rest of the semester MOST and well as the MTU Open Source Hardware Enterprise will be documenting, building and testing open source ventilators. If you want to help please do.
- Pearce JM. A review of open source ventilators for COVID-19 and future pandemics. F1000Research 2020, 9:218 (https://doi.org/10.12688/f1000research.22942.1) academia open access
Background
Follow literature review protocols from the group here:[1]
- https://news.ycombinator.com/item?id=22453100
- https://panvent.blogspot.com/
- https://www.reddit.com/r/medicine/comments/fgmsrh/open_source_crowd_sourced_medical_ventilator/
- https://hackaday.com/2020/03/12/ultimate-medical-hackathon-how-fast-can-we-design-and-deploy-an-open-source-ventilator/
- https://coronavirustechhandbook.com/hardware
- https://boingboing.net/2020/03/14/fb-group-forms-to-open-source.html
- Open-Source COVID19 Medical Supplies Requirements
- example 3d printed valve
- https://foro.coronavirusmakers.org/
- https://medium.com/frontier-technology-livestreaming/frontier-tech-4-covid-action-emerging-market-ventilation-systems-9c818cb46189
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/874279/RMVS001_Rapidly_Manufactured_Ventilator_Specification__PDF.pdf
- https://www.agorize.com/en/challenges/code-life-challenge?lang=en
How Many are Needed?
See Dave Denkenbergers' spreadsheet
- https://www.youtube.com/watch?v=jmUMolg-7nA
- https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html
- https://www.politico.com/news/2020/03/14/health-system-coronavirus-preparation-129066
- https://www.npr.org/sections/health-shots/2020/03/14/815675678/as-the-pandemic-spreads-will-there-be-enough-ventilators
- https://abcnews.go.com/Health/demand-ventilators-spikes-coronavirus-looms/story?id=69597233
- https://www.nytimes.com/2020/03/12/opinion/coronavirus-hospital-shortage.html
- FDA sweeping away regulations https://www.precisionvaccinations.com/continuous-positive-airway-pressure-cpap-machines-enhance-people-respiratory-challenges ,
Existing Designs
- https://github.com/PubInv/covid19-vent-list -- the list now updated daily
- https://www.instructables.com/id/The-Pandemic-Ventilator/
- https://www.appropedia.org/Negative_pressure_respirator
- https://app.jogl.io/project/121#about and https://www.projectopenair.org/ and the core documentation on the ventilator project https://drive.google.com/drive/folders/1TrHL40-RwSL_yWivaRF8GyKmLVJMr63j
- https://www.medonegroup.com/pdf/manuals/techManuals/Cardinal-Health-VELA-Ventilator-Service-Manual.pdf Service Manual for a Commercial Ventilator
- https://www.cbc.ca/news/canada/london/pandemic-ventilator-coronvirus-hospitals-1.5493830
- https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2044.2009.06207.x
- https://www.oxygen.protofy.xyz/
- https://e-vent.mit.edu/
- https://gitlab.com/open-source-ventilator/OpenLung
- https://simulation.health.ufl.edu/technology-development/open-source-ventilator-project/
MTU Designs
Testing Procedures
- https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak
- https://github.com/PubInv/ventmon-ventilator-inline-test-monitor
- ISO 80601-2-12 https://www.iso.org/standard/72069.html
- MDSR Minimum Requirements: http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8305
MTU Testing Procedure
- Select on of the four modes using the user interface on the ventilator:
*Continuous mechanical ventilation (CMV): used when a patient is not breathing on their own *Inverse ratio ventilation (IRV): used when a patients inhale lasts longer than their exhales(i.e 2:1 instead of 1:2) *Pressure support ventilation (PSV): when a patient has trouble completing a breath thus resulting in negative pressure during a breathing circuit *Assist Control (AC): used when a patient needs support for every breath
- Confirm that the peak inspiratory pressure (PIP), respiratory rate (RR), positive end expiratory pressure (PEEP), inspiratroy:expiratory ration (i:e), and tidal volume (TV) are accurate by using the Michigan Instruments software package that accompanies the lung (downloaded in the MI USB drive).
- Test the alarms by unplugging the machine, wiring, and appropriate tubing. The accessories that should be tested are:
*Low Pressure Alarm: Decrease the PIP value using the ventilators user interface to an abnormal value. *High Pressure Alarm: Increase the PIP value using the ventilators user interface to an abnormal value. *Oxygen Concentration Alarm: Increase/decrease the percentage of oxygen per breathe to above/below the safety range (19.5-23.5%) by mechanically increasing/decreasing the amount of O2 entering the ventilator and using an O2 sensor. *Battery Backup Alarm: Unplug the ventilator's primary battery from the voltage source. *Wire Disconnection Alarm: Unplug a wire from the circuit board in the ventilator while it is running. *Oxygen Tube Disconnection Alarm: Unplug the oxygen intake tube from the ventilator while the machine is on. *Mechanical Failure/Fatigue (# of cycles): Leave the machine running for extended periods of time (a few hours, days, weeks) and observe any inaccuracies.
- Ideal Values that Should be Targeted for a Healthy Patient:
*PIP: 10-14 cm H2O *RR: 8-12 breathes per minute (BPM)
*PEEP: 3-10 cm H2O
*I:E: 1:2
*TV: 6-8 mL/kg
*O2 Concentration: 19.5-23.5%
*FiO2: 1.0 (100%)
* Mechanical Failure/Fatigue (# of cycles): ideally for as long as the patient requires the use of the ventilation
Regulations
- FDA's activities regarding medical devices: https://www.fda.gov/medical-devices
*COVID-19 activities: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
- Policy for ventilators: https://www.fda.gov/media/136318/download
- Emergency Use Authorization: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
* A ventilator would fall under other medical devices: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidothermeddev
Safety Precautions
- Confirm that the wiring in the ventilator is correctly set-up (see wiring diagram)
- Make sure that the ventilator is properly connected to the artificial lung with the proper adapter size (see picture below)
- Confirm that the artificial lung is set-up correctly BEFORE turning the machine on (see manual below, pg.#)