Hyperbaric medicine or not?

The MACY PAN hyperbaric chambers of our DeltaO2 Centre as a non-medical wellness tool.

So far in Europe, hyperbaric chambers are known as medical devices for medical use in clinics and hospitals. However, in order to achieve this use, these devices need to comply with international and national regulations, which are defined both by their pressure level and their oxygen concentration. The comparison is as simple as the difference between taking medicines manufactured by pharmaceutical laboratories, and taking honey manufactured by the local beekeeper whose health benefits are scientifically approved for both, only that in the former, if the doses and frequencies are not respected, they can become dangerous for the individual. It is all a question of dosage and method of supply.

The same applies to hyperbaric chambers. And that's why standards have been drawn up, which include sanitary equipment.

The Spanish Society of Hyperbaric Medicine refers to the Undersea and Hyperbaric Medical Society (UHMS) for precisely defining the field of intervention of hyperbaric medicine. However, the UHMS also defines hyperbaric medicine as follows:

"For clinical purposes, the pressure should be equal to or greater than 1.4 ATA while breathing near 100% oxygen. The United States Pharmacopeia (USP) and Compressed Gas Association (CGA) Grade A specify that medical-grade oxygen should not be less than 99.0% by volume, and the National Fire Protection Association specifies USP medical-grade oxygen." https://www.uhms.org/images/indications/UHMS_HBO2_Indications_13th_Ed._Front_Matter__References.pdf

We remind you that our MACY PAN portable chambers reach a maximum pressure of 1.3ATA and if the RIGID chambers reach a pressure of 1.5ATA, they do not meet the conditions because the oxygen concentrator does not allow to exceed 97% of oxygen.

The field of intervention of sanitary hyperbaric chambers is the following:

When we promote the sale of our MACY PAN hyperbaric chambers, we never talk about these pathologies and rightly so, they are not able to cure any of them. We always confirm that we do not do medicine, that we do not cure, but we improve the quality of life both for healthy people, for example, sportsmen, and for affected people, for whom our hyperbaric chambers are a support just like doing physical activities or eating healthy... which has nothing to do with medicine but simply as a healthy habit.

The Spanish Society of Hyperbaric Medicine also refers to the European Committee for Hyperbaric Medicine, a body that defines hyperbaric medicine being even stricter than UHMS as higher than 2ATA.

The COORDINATING COMMITTEE OF HYPERBARIC MEDICINE CENTRES (CCCMH) in Spain, co-founder of the European Committee for Hyperbaric Medicine, specifies that the hyperbaric chamber:

"It is an airtight and pressurised device, rigid or flexible, of different materials, variable dimensions and shape, capable of maintaining a pressure several times higher than atmospheric pressure, allowing conditions of habitability and comfort to be occupied by healthy or sick people.".

This allows for non-therapeutic use outside the health care field.

However, the CCCMH specifies:

 "The European standard UNE-EN14931 defines hyperbaric chambers as medical devices that are subject to a specific EC certification, regardless of the certification that corresponds to them as pressure vessels. Their use in medicine also requires the authorisation of the General Directorate of Health Resources or the corresponding accrediting institution in the area of use".

Our MACY PAN hyperbaric chambers do not correspond at any time to what is stated in this standard. Rightly so, it is not a sanitary hyperbaric chamber.

The capsules of the portable chambers are made of a sanitary polymer which does not release toxic volatile particles like any other plastic and guarantees the user an exceptional quality of the air in the capsule. The oxygen concentrator itself cannot be considered sanitary because it does not allow to reach 99 % of minimum oxygen. However, this concentrator has the ISO13485 sanitary certification.