EASY COVID 19

Emergency mask for hospital ventilators

In recent days we have been contacted by a former head physician of the Gardone Valtrompia Hospital, Dr. Renato Favero, who’ve got in touch with Isinnova through a doctor from the Chiari Hospital, the health facility for which we were manufacturing the emergency valves with 3D printing process. Doctor Favero shared with us an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy, which is emerging as a concrete problem linked to the spread of Covid-19: it’s the construction of an emergency ventilator mask, realized by adjusting a snorkeling mask already available on the market.
We analyzed the proposal together with the inventor. We contacted in little time Decathlon, as ideator, productor and supplier of the snorkeling Easybreath mask. The company was immediately willing to cooperate by providing the CAD drawing of the mask we had identified. The product was dismantled, studied, and the changes to be made were evaluated. A new component was then designed to guarantee the connection to the ventilator. We called the link Charlotte valve, and we quickly printed it using 3D printing.
The prototype as a whole has been tested on one of our colleagues directly inside the Chiari Hospital, connected to the ventilator body, and has proven to be correctly working. The hospital itself was enthusiastic about the idea and decided to test the device on a patient in need. The testing was successful. We’are reiterating that the idea is designed for healthcare facilities and wants to help in realization of an emergency mask in the case of a full-blown difficult situation, where is not possible to in find official healthcare supplies. Neither the mask nor the link are certified and their use is subject to a situation of mandatory need.
Usage by the patient is subjected to the acceptance of use of an uncertified biomedical device, by providing a signed declaration.
Whereas the effectiveness of the project, we decided to urgently patent the link valve (Charlotte Valve), to prevent any speculation on the price of the component. We clarify that the patent will remain free to use, because it is in our intention that all hospitals in need could use it if necessary.
We decided to freely share the file for the realization of the link in 3d printing. Unlike the respirator valve, the link is easy to make, so it is possible for all makers to try to print it correctly.

Healthcare facilities in difficulty will be able to purchase the Decathlon mask (here the link), and get in contact with 3d printers who could make the piece and provide it.

We clarify that our initiative is totally non-profit, we will not obtain any royalties on the idea of ​​the link, nor on the sales of Decathlon masks.

Below you will find:

Document to be signed by the patient for the use of the device in an emergency situation

  • Link to the page of the Ministry of Health, which explains how to activate the emergency procedure for compassionate care

  • Video instructions on preparing the emergency mask once all the components are obtained

  • .stl, .dwg and .step files for 3D printing

We can provide further support and further details to healthcare facilities and makers who want to make the connection, if necessary.

This device is not certified. It is recommended, for those who want to use the documentation to replicate it, to avail themselves of the collaboration of specialized technical personnel for the realization and supervision of a doctor for the use. It is absolutely inadvisable to replicate it if you do not have such skills.

Isinnova declares that it releases the drawings, logics and any other intellectual property rights relating to Charlotte valve device is released free of charge provided that it is NOT used for commercial purposes.

The mold was created in collaboration with the Oldrati group! healthcare@oldrati.com and +39 0359160244 are the contacts that have just been created for all institutions, hospitals, bodies, associations that want snorkeling masks and charlotte valves.

Emergency mask for hospital ventilators

In recent days we have been contacted by a former head physician of the Gardone Valtrompia Hospital, Dr. Renato Favero, who’ve got in touch with Isinnova through a doctor from the Chiari Hospital, the health facility for which we were manufacturing the emergency valves with 3D printing process. Doctor Favero shared with us an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy, which is emerging as a concrete problem linked to the spread of Covid-19: it’s the construction of an emergency ventilator mask, realized by adjusting a snorkeling mask already available on the market.
We analyzed the proposal together with the inventor. We contacted in little time Decathlon, as ideator, productor and supplier of the snorkeling Easybreath mask. The company was immediately willing to cooperate by providing the CAD drawing of the mask we had identified. The product was dismantled, studied, and the changes to be made were evaluated. A new component was then designed to guarantee the connection to the ventilator. We called the link Charlotte valve, and we quickly printed it using 3D printing.
The prototype as a whole has been tested on one of our colleagues directly inside the Chiari Hospital, connected to the ventilator body, and has proven to be correctly working. The hospital itself was enthusiastic about the idea and decided to test the device on a patient in need. The testing was successful. We’are reiterating that the idea is designed for healthcare facilities and wants to help in realization of an emergency mask in the case of a full-blown difficult situation, where is not possible to in find official healthcare supplies. Neither the mask nor the link are certified and their use is subject to a situation of mandatory need.

 

Usage by the patient is subjected to the acceptance of use of an uncertified biomedical device, by providing a signed declaration.
Whereas the effectiveness of the project, we decided to urgently patent the link valve (Charlotte Valve), to prevent any speculation on the price of the component. We clarify that the patent will remain free to use, because it is in our intention that all hospitals in need could use it if necessary.
We decided to freely share the file for the realization of the link in 3d printing. Unlike the respirator valve, the link is easy to make, so it is possible for all makers to try to print it correctly.

Healthcare facilities in difficulty will be able to purchase the Decathlon mask (here the link), and get in contact with 3d printers who could make the piece and provide it.

We clarify that our initiative is totally non-profit, we will not obtain any royalties on the idea of ​​the link, nor on the sales of Decathlon masks.

Below you will find:

  • Document to be signed by the patient for the use of the device in an emergency situation

  • Link to the page of the Ministry of Health, which explains how to activate the emergency procedure for compassionate care

  • Video instructions on preparing the emergency mask once all the components are obtained

  • .stl, .dvg and .step files for 3D printing

We can provide further support and further details to healthcare facilities and makers who want to make the connection, if necessary.

This device is not certified. It is recommended, for those who want to use the documentation to replicate it, to avail themselves of the collaboration of specialized technical personnel for the realization and supervision of a doctor for the use. It is absolutely inadvisable to replicate it if you do not have such skills.

Isinnova declares that it releases the drawings, logics and any other intellectual property rights relating to the Easy Covid device is released free of charge provided that it is NOT used for commercial purposes.

Unfortunately, printing technologies are different and printers can have different results. At this link you can download the model of a reinforcement jacket for the Charlotte valve. Here And a valve file with stronger nerves. Here

The file for the masks produced by the OCEAN REAF is available HERE
The file for the masks produced by the MARES is available HERE

Unfortunately, printing technologies are different and printers can have different results. At this link you can download the model of a reinforcement jacket for the Charlotte valve. Here And a valve file with stronger nerves. Here

The file for the masks produced by the OCEAN REAF is available HERE
The file for the masks produced by the MARES is available HERE

3D print the “Charlotte Valve 1” file if your mask if a model 1

Depending on the needs, we have identified different configurations, that you find in the following diagram.

Following some requests, we recommend some print settings (not mandatory) for the 3D production of the Charlotte and Dave components for the assisted breathing mask. For the production of these pieces, since high precision is not required, an FDM filament printer with “basic” settings is more than sufficient;

PLA filament 1.75 mm

Nozzle temperature: 205 – 210 ° C

Builtplate temperature: 35-50 ° C

Layer thickness: 0.2 mm

Supports: only touching the builtplate.

Orientation: Charlotte leaning on the terminal plane (as shown in the images), Dave leaning on the larger diameter vertically.

As for the printing material, we recommend the most common filament on the market, the PLA (polylactic); this for several reasons:

Odorless (remember that patients must breathe air passing through these components)

The least dangerous possible (PLA is not very dangerous and biocomposable)

Relatively flexible (must be elastically deformed to be coupled with other components).

3D print the “Charlotte Valve 1” file if your mask if a model 1

Depending on the needs, we have identified different configurations, that you find in the following diagram.

Following some requests, we recommend some print settings (not mandatory) for the 3D production of the Charlotte and Dave components for the assisted breathing mask. For the production of these pieces, since high precision is not required, an FDM filament printer with “basic” settings is more than sufficient;

PLA filament 1.75 mm

Nozzle temperature: 205 – 210 ° C

Builtplate temperature: 35-50 ° C

Layer thickness: 0.2 mm

Supports: only touching the builtplate.

Orientation: Charlotte leaning on the terminal plane (as shown in the images), Dave leaning on the larger diameter vertically.

As for the printing material, we recommend the most common filament on the market, the PLA (polylactic); this for several reasons:

Odorless (remember that patients must breathe air passing through these components)

The least dangerous possible (PLA is not very dangerous and biocomposable)

Relatively flexible (must be elastically deformed to be coupled with other components).

The consent for the patient and the procedure illustrated below refer to the laws of the Italian state, we do not know if they are also valid abroad. It is reccomended to evaluate the eventually compliance of the device to the local laws

Authorisation for the compassionate use of medical devices without CE marking for the intended purpose requested.

In exceptional cases of necessity and urgency, in the interest of protecting the health of an individual patient and in the absence of viable therapeutic alternatives, a medical device without CE marking for the proposed indication may be used for compassionate use.

The authorisation of the Ministry of Health and the favourable opinion of the Ethics Committee are required for the compassionate use of a device. The treating physician or the manufacturer (with the support of the specific report of the treating physician) must submit a reasoned request with the relevant documentation to the Ministry of Health and the Ethics Committee. The request has to contain, moreover, information about the medical device, the clinical condition of the patient to be treated and the rational use of the device for compassionate use. The Ministry of Health assess the application and releases a written authorisation within one to 10 days, depending on the urgency of the case and the expected date of treatment. The Ethics Committee evaluates, in addition to the ethical-scientific aspects of the proposed treatment, insurance coverage and informed consent.

http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=UC&idSrv=A1&flag=P

Document to be signed by the patient for the use of the device in an emergency situation ( download )

To face the eventual request of pieces we want to put in direct contact Makers and hospitals!

Are you a hospital?

Click on the icon and use the database to find the creator closest to you. You will find all the information to contact him and have him send you the 3D printed pieces.

Are you a Maker?

Click the icon and fill in the contact form. Once verified some conditions, we will put you in the Makers list that the hospitals could contact. Privacy policy

The consent for the patient and the procedure illustrated below refer to the laws of the Italian state, we do not know if they are also valid abroad. It is reccomended to evaluate the eventually compliance of the device to the local laws

Authorisation for the compassionate use of medical devices without CE marking for the intended purpose requested.

In exceptional cases of necessity and urgency, in the interest of protecting the health of an individual patient and in the absence of viable therapeutic alternatives, a medical device without CE marking for the proposed indication may be used for compassionate use.

The authorisation of the Ministry of Health and the favourable opinion of the Ethics Committee are required for the compassionate use of a device. The treating physician or the manufacturer (with the support of the specific report of the treating physician) must submit a reasoned request with the relevant documentation to the Ministry of Health and the Ethics Committee. The request has to contain, moreover, information about the medical device, the clinical condition of the patient to be treated and the rational use of the device for compassionate use. The Ministry of Health assess the application and releases a written authorisation within one to 10 days, depending on the urgency of the case and the expected date of treatment. The Ethics Committee evaluates, in addition to the ethical-scientific aspects of the proposed treatment, insurance coverage and informed consent.

http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=UC&idSrv=A1&flag=P

Document to be signed by the patient for the use of the device in an emergency situation ( download )

To face the eventual request of pieces we want to put in direct contact Makers and hospitals!

Are you an hospital?

Click here and use the database to find the maker closer to you. You will find all the informations to contact him and to have the 3D printed pieces sent.

Are you a Maker?

Click here and fill in the contact form. Once verified some conditions, we will put you in the Makers list that the hospitals could contact.

Are you a doctor?

Share usage information by filling out the form or read the directions and results of other doctors.

Fill in the Form

Read the indications

 

Are you a doctor?

Share usage information by filling out the form or read the directions and results of other doctors.

Fill in the Form

Read the indications

 

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