Covid-19 emergency

Emergency mask for hospital respirators

Covid-19 emergency masks

Few days ago, we were contacted by Doc. Gualtiero Lamagna, agent of the VYGON Italia a producer of medical devices. With Doc. Lamagna we had a long telephonic conversation during which we have discussed the current emergency. We have also talked about the producer Isinnova in Brescia and about their extraordinary work – to which all of us in Fablessy have joined – about the production of the Charlotte valve for the SNORKELING EASYBREATH masks distribued by Decathlon with the only goal to save as many lives as possible. The invention has interested both us and Doc. Lamagna who has proposed a preventive collaboration in case of lack of masks for the intesive care unities in sanitary facilities.

Obviously, we agreed to the proposal.

Without going through the details, during the phone call we understood that the main problem was modelling an adapter like the one designed by the Isinnova team but it had to work as a connection between the Decathlon snorkeling masks and other systems of mechanical ventilation. In other words: we had to create a connector with one female connection which could attach the Boussignac Valve for the mechanical ventilation with constant positive airway pressure (C-PAP), used in many hospitals.

When the phone call was over we started going through various options and we obtained the result we were hoping for.

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What we have designed is a connector to connect the Decathlon snorkeling mask “Easybreath” with the Boussignac Valve.

The connector, called “Faby – 3D” in accordance with the technology used, is composed of a connection to the Easybreath mask on one side, and a standart female 22 mm connection on the other, suitable also for other possible connector uses. This connector allows the Decathlon “Easybreath” to become an emergency breathing mask in case of lack of C-PAP masks in the sub-intensive care unities due to the spread of Covid-19.

We would like to clarifay that our work was completely free, with philantropic aims only. Everyone can produce and distribute it. We also would like to remark that our prototype is not provided with any certification, its use is limited to “real and proven emergencies” and to “compassionate use” (see the usage rules for your country), during which there would not be the chance to use instruments certificated by sanitary producers and only after written authorization (see the usage rules for your country) by the patient and/or the sanitary facilities that wants to use the device.

To avoid any kind of speculation we have also asked clarifications from Decathlon in order to deliver the device in a completely free form: to be used and realized by anyone, following the example of our collegues of Issinova. After an e-mail exchange, Decathlon has asked us not to patent the device since they own the intellectual property of the product and, besides, they have not started any kind of contract for the design of connectors but they are aware of the positive use of their product by many manifacturers.

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Our contribution to the coronavirus emergency

All of us, in Fablessy, in our possibilities, feel obliged to help the sanitary facilities in case they are not be able to get certified devices to save people’s lives.

The final test of the FABY-3D prototype was excellent. Its structure of accomodation is similiar to the one designed by Isinnova and it is easy and quick to attach on both sides.

The estimated printing time varies between 2 and 2:30 hours, according to the printer used.

Whatever kind of printer you’re using we suggest to respect these values:

Filament: PLA 1,75 mm

Nozzle temperature: 205 – 215 °C

Printing plate temperature: 35 – 50 ° C

Layer thickness: 0,2 – 0,3 mm

Holders: not required.

Orientation: see photos above.

Regarding the printing material, as for the Isinnova valve, we too advice the use the filament in commerce, the PLA (polylactic); PLA is indicated for several reasons:
It is Odourless (remember that patients will breathe the air that passes through this device);

It is Relatively Flexible (it has to elastically deform to attach itself to the other components).

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If anyone is interested to test our connector in the sanitary field you can contact us through our official channels or send an email to [email protected].

The device is in test phase at the UOC Anaesthesia and Rianimation of the hospital “Maria SS Addolorata” in Eboli, ASL Salerno, directed by Doctor Fernando Chiumiento, waiting for the last positive tests.

Following the 3D file of the “FABY-3D” connectort that can be used to be printed in 3D for the Decathlon Easybreath mask :  (DOWNLOAD)

Following the 3D file of the “FABY-3D” connectort that can be used to be printed in 3D for the SEA VU DRY Mares mask :  (DOWNLOAD)

Therefore, Fablessy declares to realise the drawings, the logistics and every other right of intellectual property regarding the device “FABY-3D” freely on condition that it will NOT be used for commercial purposes.

Refer to Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)

We would like to precise that the device is not provided with any certificate and could present some contraindications/malfunctions if not made by competent technical staff.

Therefore, we advice to use technical staff and the supervision of a doctor.

Authorization to compassionate use of medical devices without CE mark for the required use.

We would like to remark once more that our device does not come with any certification or CE mark, its use is only compassionate in case of a lack of devices certified by sanitary producers or valid alternatives also certified and authorizied by competent authorities.

To learn more about compassionate use, consult the usage policy for your country.

The consent of the patient and the procedures we have talked about refer to the italian laws. We are not aware if they are valid abroad. It is necessary to value the compliance of the device with local laws.

For any information regarding the technical aspects or advices on your experiences with the printing of the connector FABY-3D you can contact us through our site https://www.fablessy.com/backup_old_site/ , our socials Facebook o Instagram or our email : [email protected] 

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