ARIA 19 _ The Project
In the beginning of March 2020, we deposited an international Patent through our company Mestel Safety, under the brand OCEAN REEF. OCEAN REEF manufactures full face masks for snorkeling and scuba purposes, while the brand Safety Protection Equipment, manufactures gas masks.
The Filed Patent is for an adapter to connect full face snorkeling masks to filters. The aim was to transform the snorkeling mask, into a personal protection mask.
We converted our production to offer a possible solution and help providing alternative PPE in a time of dire need.
Mestel Safety SRL-Ocean Reef Group received the extraordinary validation for the Personal Protective Equipment of third category from the Italian National institute for Insurance against industrial Injuries, INAIL. The Aria 19 Kit is constituted by the Aria mask assembled with the APA adaptor (Aria Protection Adaptor) and the P3 filter, certified under the EN136: 2000 standard.
HOW DOES IT WORK
CLINICAL INFORMATION
3D OPEN SOURCE PROJECT
COMPONENTS
AIR FLUX
The ARIA 19 Kit with a certified and properly installed filter, can assist in the filtration of breathable air and reduce the inhalation of contaminants.
APA adaptor has a non-return valve, so only fresh air passes through the filter and only filtered air enters into the mask.
The exhausted air has a different channel and it is expelled from the lower part of the mask, where another non-return valve ensures air will only exit from there.
(In the open source project is also available the design of the Exhausted Valve Cover 22mm: an another adaptor made to filter the exhaled air).
Our snorkeling masks breathing technology is patented and certified.
The airflow and the CO2 levels are tested and safe.
The converted mask is a reusable and cleanable full-face shield.
CONFIGURATIONS
The adaptors allow to connect most common filters to the mask.
APA is compatible with all the filters with EN 148-1 connection.
RD40-22mm can be screwed on APA to connect HEPA filters (40mm 1/7″ threaded outlets).
All the Ocean Reef mask are compatible with our optical lens support.
Lenses are available in different graduation.
To filter exhausted air, wear a surgical mask on ARIA or install a filter with the exhaust valve cover (3D model available).
The adaptors allow to connect most common filters to the mask.
APA is compatible with all the filters with EN 148-1 connection.
RD40-22mm can be screwed on APA to connect HEPA filters (40mm 1/7″ threaded outlets).
All the Ocean Reef mask are compatible with our optical lens support.
Lenses are available in different graduation.
To filter exhausted air, wear a surgical mask on ARIA or install a filter with the exhaust valve cover (3D model available).
MEDICAL EXPERIENCE
We are using this new patented filtering mask. It is very innovative and much more safe than surgical masks. We use it, above all, for dental procedures or digestive endoscopy treatments.
My anesthsia group bought around 200 of your masks to be repurposed for us. They are actually really comfortable and feel safer than the n95/face shield.
We have to protect ourselves from a virus we have very little information on. By wearing this, I’m decreasing of contracting or giving the virus to someone else. I can’t accidentaly touch my face and the attached viral filter ensures my air is purified. I clean it after every patient I see, easily. With the lack of WHO advised PPE, this is a cheaper and efficient alternative. I have to thank Avendale Limited for providing me the 3d printed adaptor.
CERTIFICATION
On May 27 2020 Mestel Safety SRL-Ocean Reef Group received from the Italian National institute for insurance against industrial injuries, INAIL, the extraordinary validation (protocol: INAIL.72000.27/05/2020.0016170) for the Personal Protective Equipment of third category constituted by the Aria/UNO snorkeling mask assembled with the APA adaptor (Aria Protection Adaptor) and the P3 filter, certified under the EN136: 2000 standard. This validation complies with the Italian Law art.15 comma 3 decreto-legge Governo Italiano 17 marzo 2020, n.18 Emergenza COVID – 19.
Extraordinary validation released by INAIL (Italian National institute for insurance against industrial injuries) for OCEAN REEF snorkeling masks with APA adaptor and P3 filter as Category III Personal Protection Equipment
Original document (in Italian)
Declaration of Conformity
ARIA/UNO FULL FACE SNORKELING MASK WITH APA (ARIA PROTECTION ADAPTOR) AND P3 FILTER
Extraordinary validation released by INAIL (Italian National institute for insurance against industrial injuries) for OCEAN REEF snorkeling masks with APA adaptor and P3 filter as Category III Personal Protection Equipment
English Translation
DECONTAMINATION
SANITIZATION PROTOCOL FOR YOUR ARIA 19, APA AND RD 40 ADAPTORS
After some preliminary tests carried out on Aria 19, APA and RD 40 adaptors, the following sanitization procedures are proposed.
They are based on recommendations from CDC, OSHA, the National Academy of Science and many hospitals in Europe, Canada, and USA. All the Aria 19 mask and adaptors are functional and seal well after each sanitization process.
- Remove any filter connected to the adaptor prior to sanitization.
- NEVER use any solvent, cleaner or abrasive product to clean the Aria 19 Mask, the RD40 and the APA Adaptor.
- Do not sanitise a mask+adaptors protection system that is clearly damaged.
- Be careful do not deform the Aria 19 Mask, the RD40 and the APA Adaptor during sanitization as it could negatively impact its fit.
- Follow one of the methods below.
Treatment in Diluted NaClO (bleaching solution)
1. Place the Aria 19 mask, the RD40 and APA adaptors in a commercial solution of NaClO-sodium hypochlorite (dilution: max 2.5-3% vol/vol) for 5-10 minutes.
2. Possibly, each mask and adaptors should not overlap or cover the other ones.
3. After sanitization, remove carefully the mask and the adaptors from the solution, rinse deeply under fresh water just to remove all the hypochlorite residuals and allow the perfect drying in a safe and no contaminated environment.
4. Maximum allowed sanitization cycles: 120
Treatment with Sanitising Wipes
1. Clean Aria 19 mask, the RD40 and APA adaptors with commercial alcohol based, benzalkonium chloride or hypochlorite based wipes.
2. After sanitization, remove the wipes, disposing them properly, and allow the perfect drying in a safe and not contaminated environment.
3. Maximum allowed sanitization cycles: 400
Treatment in Boiling Water (suggested only for domestic use)
1. Place the Aria 19 mask, the RD40 and APA adaptors in boiling water for 5-10 minutes.
2. Possibly, each mask and adaptors should not overlap or cover the other ones.
3. After sanitization, remove carefully the mask and the adaptors from hot water, allowing the perfect drying in a safe and not contaminated environment.
4. Maximum allowed sanitization cycles: 160
Filter Sanitization
1. Clean the filter with commercial alcohol based, benzalkonium chloride or hypochlorite based wipes.
2. After sanitization, remove the wipes, disposing them properly, and allow the perfect drying in a safe and not contaminated environment.
3. Maximum allowed sanitization cycles: 500
Treatment in Diluted Ethanol
1. Place the Aria 19 mask, the RD40 and APA adaptors in a commercial solution of ethanol (dilution: 3-5% vol/vol) for 5-10 minutes.
2. Possibly, each mask and adaptors should not overlap or cover the other ones.
3. After sanitization, remove carefully the mask and the adaptors from the solution, rinse deeply under fresh water just to remove all the alcohol residuals and allow the perfect drying in a safe and not contaminated environment.
4. Maximum allowed sanitization cycles: 120
Treatment with Medical Disinfectants
1. Clean Aria 19 mask, the RD40 and APA adaptors with commercial medical disinfectants based on
benzalkonium chloride, ethanol or chlorhexidine for 5-10 minutes.
2. Possibly, each mask and adaptors should not overlap or cover the other ones.
3. After sanitization, remove carefully the mask and the adaptors from the solution, rinse deeply under fresh water just to remove all the alcohol residuals and allow the perfect drying in a safe and not contaminated environment.
4. Maximum allowed sanitization cycles: 400
Treatment in Dishwasher (suggested only for domestic use)
1. Place the Aria 19 mask, the RD40 and APA adaptors in a dishwasher for one (1) hour at 70°C using
dishwasher soap. The dishwasher should be sterilized prior to use. They should be the only objects in the dishwasher.
2. After sanitization, remove the mask and the adaptors from the machine, allowing the perfect drying in a safe and not contaminated environment.
3. Maximum allowed sanitization cycles: 160
Upon completion of the cycle, the filter, the Aria19 mask, the RD40 and APA adaptors must be stored in a closed PE bag ready for the next use in a dry and cool place. If one of them appears visually damaged or soiled, it should be discarded. Any mask and/or adaptors that has exceeded the sanitization cycles should be discarded as well.
Please note that successful completion of the chosen method and cycle signifies appropriately sanitised filter, Aria 19 mask, RD40 and APA adaptors.
Please note that this protocol is not formally approved, and each hospital should consult their EH&S officers or infection disease specialists for a standard operating procedure.
INSTRUCTIONS
On May 27 2020 Mestel Safety SRL-Ocean Reef Group received from the Italian National institute for insurance against industrial injuries, INAIL, the extraordinary validation (protocol: INAIL.72000.27/05/2020.0016170) for the Personal Protective Equipment of third category constituted by the Aria/UNO snorkeling mask assembled with the APA adaptor (Aria Protection Adaptor) and the P3 filter, certified under the EN136: 2000 standard. This validation complies with the Italian Law art.15 comma 3 decreto-legge Governo Italiano 17 marzo 2020, n.18 Emergenza COVID – 19.
FILTERS
APA + P3 FILTER
40mm threading canister fiters EN 148-1
While we may provide Multipurpose and P3 Filters, please note that any filter with that threading is compatible with our APA adaprtor.
APA + RD40 + HEPA FILTER
40mm 1/7″ threaded outlets
With this, you can connect an APA, or SGE Gas Masks and other PPE that use the NATO 40mm standard, to rd40-22mm devices such as hydrophobic bidirectional filters, or similar that can commonly be found in hospitals.
ISO 5356-1 compliant bacterial and viral removal filters we have considered for application are following:
PALL BB50T : specs HERE.
Medtronic DAR™ Adult − Pediatric Electrostatic Filter : specs HERE.
and many more.
We are not affiliated with any of these manufacturers. There are many more that provide certified, similar products.
How long does the filter last?
The service life of a respiratory filter depends on its size and on the conditions of use. Factors affecting service life:
• concentration of the contaminants
• combination of the contaminants
• air humidity
• temperature
• duration of use
• breathing rate of the user
Since the service life is influenced by many factors, it is not possible to give an estimated service life.
The end of service life is generally recognizable by:
• gas filters by a noticeable taste or smell of the
contaminant
• particle filters by an increased breathing
resistance
• combination filters a noticeable taste or smell
and/or an increased breathing resistance
__________________
Anti bacterial-anti viral filters are usually used on breathing apparatuses. Manufacturers state that the intended use is for 24/48hr continuous use before needing to change (depending on brand/type).
Medical Disclaimer
The following content, including but not limited to project descriptions, preliminary test results, figures/images, and prototypes, published here is meant to maximize potential public benefit during this SARS-CoV-2 (formerly CoVID-19) crisis, specifically in addressing the urgent need around PPE shortage. The content is currently being submitted to the U.S. Food and Drug Administration (FDA) for review and approval.
PLEASE NOTE: The content has not been peer reviewed. The Authors make no representations or warranties of any kind (express or implied) relating to accuracy, safety, usefulness, usability, marketability, performance, or otherwise of the content released here. The Authors disclaim all express and implied warranties of merchantability and fitness of the content for a particular purpose, and disclaims all express and implied warranties regarding non-infringement of any patent, copyright, trademark, or other rights of third parties in the content or use of the content, or in the making, using, or selling products or services by any person or entity.
People or entities attempting to use the content in any way, including creating products or offering services, assume all risk and responsibility related to those uses, including all legal and regulatory compliance, safety, efficacy, performance, design, marketability, title, and quality. The Authors assume no liability related to the actions of third parties and in respect of any infringement of any patent, copyright, or other right of third parties.
The content/device has not been used in formal testing with human subjects at this time.
Although no determination has been made with respect to this design,the Department of Health and Human Services (DHHS) has declared liability immunity for medical countermeasures against COVID-19. https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx