OxyGEN
Project
La voluntad de contribuir con nuestro conocimiento a la paliación de los efectos devastadores de esta crisis sanitaria sin precedentes en los últimos años. Esta pandemia puede provocar situaciones de escasez y desabastecimiento de equipo y material médico en algunos lugares (zonas rurales, países en vías de desarrollo) si la situación empeora.
We use a set of cams to change the volume of the air sent to the patient. For each I:E ratio, we have 5 cams. This is what the spanish sanitary agency asked us to do in order to get the authorization, but there is no limit of cams, thanks to the interchangeable cam system, you can extend the number of cams in order to cover a wider volume spectrum (in the specific case of Seat version only the 1:2 was delivered with the machine).
This is when the patient wants to do one thing, but the ventilator wants to do another. A professional ventilator usually has sensors to detect what the patient wants, in order to adapt to this situation. But this is not the case of emergency ventilators like oxyGEN: this is why it has to be used on patients sedated and paralyzed.
This is the important process of gradually allowing the patient to do more of the breathing for themselves. We could view it as the “waking up” process. The more respiration a patient has been able to do while on a ventilator the more rapidly this will occur. An emergency device like oxyGEN does not offer an easy way of doing the weaning.
No, at this stage, the oxyGEN device has no sensor connected to the patient which could act on oxyGEN itself. A professional ventilator could usually detect the act of starting inspiration, coughing… and then adapt on the fly the pressure/volume in order to avoid fighting against the patient. But this doesn’t append so much with a patient sedated and paralysed.
The enclosure of the IP version is stainless steel. So you would ideally need a laser cutting machine able to cut through 1mm of metal, and a bending machine. The cams and the base of the chassis are 3mm thick so you would need either a more powerful laser cutting machine or a CNC. Then you need a milling machine, hacksaw, multi meter etc...
Any 12V car wiper engine can be used. They are very reliable (able to work continuously ranging from 3 to 5000h) and very easy to find anywhere: the one we used for the spanish approvals is www.doga.es wiper motor, with reference 11194592B00E and the following specs: 12vDC, 48W, 6NM, 30RPM max. Any other equivalent wiper engine will work.
Because of this mechanical design, it’s easy to add alarms and sensors to the oxyGEN device on the go. The first IP version includes a light alarm warning the doctor when the engine stops working. Other sets of alarms are available, for instance monitoring if the bag of the BVM is correctly pressed. Every oxyGEN-M or IP can be retrofitted with these sets.
The spanish sanitary agency, AEMPS, granted a special authorization of use for the oxyGEN IP, the 30th of march 2020, during the covid19-crisis. This authorization is a special procedure designed for the current emergency situation in order to respond quicker than usual, but asking for a precise list of testing to be done successfully, under hospital control. Concretely, OxyGEN-IP are authorized to be used under a clinical study named RES-COVID.
There are 2 sets of tests: medical and electromagnetic (EM). The medical tests have to be passed in hospitals, and are conducted by doctors, who evaluate the device independently, and have to consent. At the end of the medical tests, an “in vivo” test has to be performed, and then, if successful, a long test with a real covid-19 patient. The EM tests include 9 phases, and have to be passed by a certified company (IDNEO in our case). Those EM tests are done under the european community norm, so they could be used as such for other countries.
The M version follows the exact same medical testing in the hospital, and passes it successfully, including the “in vivo” one on animals, and with a real covid-19 Patient. But the M version didn’t go through the 9 Electromagnetic tests needed to have the authorization: it would have been easier for the M version to succeed the EM test, because of the nonmetallic enclosure, but we are a small team and didn’t have the resources to pass both machines.
Each country seems to have created a special fast procedure due to the Covid-19 emergency crisis, in order to authorize emergency ventilators quickly. But each country will have their own rules. oxyGEN is one of the very few to have an authorization of use in a european country: this should ease the process in other countries, especially if you could use part of the documentation we have published. Sometimes, they will ask different volume/I:E ratios, this is why we have published the mathematical file to create different cams.
To any qualified healthcare professional who is in an extreme situation with a shortage of assisted ventilators and needs a device of last resort that automates an AMBU type manual resuscitator, usually found in ambulances. This device can be built in a short time and with readily available materials. It is a device designed to avoid life and death situations in emergency triages, not to replace other superior, professional and much safer devices.
La voluntad de contribuir con nuestro conocimiento a la paliación de los efectos devastadores de esta crisis sanitaria sin precedentes en los últimos años. Esta pandemia puede provocar situaciones de escasez y desabastecimiento de equipo y material médico en algunos lugares (zonas rurales, países en vías de desarrollo) si la situación empeora.
We use a set of cams to change the volume of the air sent to the patient. For each I:E ratio, we have 5 cams. This is what the spanish sanitary agency asked us to do in order to get the authorization, but there is no limit of cams, thanks to the interchangeable cam system, you can extend the number of cams in order to cover a wider volume spectrum (in the specific case of Seat version only the 1:2 was delivered with the machine).
This is when the patient wants to do one thing, but the ventilator wants to do another. A professional ventilator usually has sensors to detect what the patient wants, in order to adapt to this situation. But this is not the case of emergency ventilators like oxyGEN: this is why it has to be used on patients sedated and paralyzed.
This is the important process of gradually allowing the patient to do more of the breathing for themselves. We could view it as the “waking up” process. The more respiration a patient has been able to do while on a ventilator the more rapidly this will occur. An emergency device like oxyGEN does not offer an easy way of doing the weaning.
No, at this stage, the oxyGEN device has no sensor connected to the patient which could act on oxyGEN itself. A professional ventilator could usually detect the act of starting inspiration, coughing… and then adapt on the fly the pressure/volume in order to avoid fighting against the patient. But this doesn’t append so much with a patient sedated and paralysed.
The enclosure of the IP version is stainless steel. So you would ideally need a laser cutting machine able to cut through 1mm of metal, and a bending machine. The cams and the base of the chassis are 3mm thick so you would need either a more powerful laser cutting machine or a CNC. Then you need a milling machine, hacksaw, multi meter etc...
Any 12V car wiper engine can be used. They are very reliable (able to work continuously ranging from 3 to 5000h) and very easy to find anywhere: the one we used for the spanish approvals is www.doga.es wiper motor, with reference 11194592B00E and the following specs: 12vDC, 48W, 6NM, 30RPM max. Any other equivalent wiper engine will work.
Because of this mechanical design, it’s easy to add alarms and sensors to the oxyGEN device on the go. The first IP version includes a light alarm warning the doctor when the engine stops working. Other sets of alarms are available, for instance monitoring if the bag of the BVM is correctly pressed. Every oxyGEN-M or IP can be retrofitted with these sets.
The spanish sanitary agency, AEMPS, granted a special authorization of use for the oxyGEN IP, the 30th of march 2020, during the covid19-crisis. This authorization is a special procedure designed for the current emergency situation in order to respond quicker than usual, but asking for a precise list of testing to be done successfully, under hospital control. Concretely, OxyGEN-IP are authorized to be used under a clinical study named RES-COVID.
There are 2 sets of tests: medical and electromagnetic (EM). The medical tests have to be passed in hospitals, and are conducted by doctors, who evaluate the device independently, and have to consent. At the end of the medical tests, an “in vivo” test has to be performed, and then, if successful, a long test with a real covid-19 patient. The EM tests include 9 phases, and have to be passed by a certified company (IDNEO in our case). Those EM tests are done under the european community norm, so they could be used as such for other countries.
The M version follows the exact same medical testing in the hospital, and passes it successfully, including the “in vivo” one on animals, and with a real covid-19 Patient. But the M version didn’t go through the 9 Electromagnetic tests needed to have the authorization: it would have been easier for the M version to succeed the EM test, because of the nonmetallic enclosure, but we are a small team and didn’t have the resources to pass both machines.
Each country seems to have created a special fast procedure due to the Covid-19 emergency crisis, in order to authorize emergency ventilators quickly. But each country will have their own rules. oxyGEN is one of the very few to have an authorization of use in a european country: this should ease the process in other countries, especially if you could use part of the documentation we have published. Sometimes, they will ask different volume/I:E ratios, this is why we have published the mathematical file to create different cams.
To any qualified healthcare professional who is in an extreme situation with a shortage of assisted ventilators and needs a device of last resort that automates an AMBU type manual resuscitator, usually found in ambulances. This device can be built in a short time and with readily available materials. It is a device designed to avoid life and death situations in emergency triages, not to replace other superior, professional and much safer devices.