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Summary and recommendations using the BioBarica Medium Hyperbaric Oxygen Chamber

 

The Biobarica (RevitalAir) 430 chamber is a soft chamber that goes to a maximum of 1,4 ATM and uses 90% Oxygen enriched air from an Airsep Oxygen concentrator. The BioBarica chamber is an ancillary therapy and no claims, either real or implied are being made. This type of hyperbaric therapy is considered medium pressure Hyperbaric Oxygen Therapy (mHBOT).

 

There are 15 classified medical conditions for which hard chamber HBOT is officially approved (arterial gas embolism, decompression sickness, Carbon monoxide poisoning, Clostridial Myositis and myonecrosis (Gas gangrene), crush injuries, compartment Syndrome and other traumatic ischaemias, enhancement of healing in selected problem wounds, necrotising soft tissue infections, refractory osteomyelitis, delayed radiation injury, compromised skin grafts and flaps, acute thermal burns, severe blood loss anaemia, inoperable brain abscesses, central retinal artery thrombosis, idiopathic sudden, sensorineural hearing loss). More information on accredited hard chambers can be obtained from the Southern African Undersea and Hyperbaric Medical Association (www.sauhma.org).

 

In recent years, it has become internationally accepted that many other conditions may benefit from the process of “hyperoxia”; which is the process of increasing the level of Oxygen within the body.

 

mHBOT assists as a co-adjuvant therapy with a very large number of conditions where mHBOT has proved very successful but are not yet endorsed by the medical schemes as medical treatments due to ongoing clinical research.

 

A brief summary of conditions where mHBOT serves as a co-adjuvant therapy includes but are not limited to: 

 

General use: Stress, Depression, Rejuvenation.

Neurology: Autism, Cerebral Palsy, Multiple Sclerosis, Parkinson's Disease.

Wound Care: Burns & Grafts, Diabetic Ulcers.

Musculoskeletal Recovery: Sports Injuries, Muscle, tendon & bone injuries

Chronic Conditions: Cancer, Arthritis, Chronic Pain, Fibromyalgia, Varicose Veins, Sleep Disorders, Circulatory Disorders, Migraines & Headaches

  

Entering a Biobarica (RevitalAir) 430 chamber signifies a clear understanding and acceptance of these recommendations and a declaration that there are no conditions present that would impede or harm a person from using the chamber. 

 

General

 

Biobarica hyperbaric sessions invoiced directly through Oxygenate (Pty) Ltd will be treated as private and are not medical aid claimable. All packages carry a three-month expiry period from date of purchase. Sessions not cancelled at least 24 hours in advance will be fully charged. Late sessions will be cut down in time accordingly. There will be no reimbursement of packages after three sessions have been used.

 

Medical Aid

 

At present, mHBOT administered by a Biobarica chamber is not covered by medical aids in South Africa.

 

Session duration and frequency

 

mHBOT consist of a series of sessions inside the Biobarica 430 chamber for period from 60 to 90 minutes. The amount of sessions and their duration will vary from person to person.

 

Informed Consent declaration

 

I hereby authorize Oxygenate (Pty) Ltd and any agent, employee, franchisee or otherwise nominated person thereof to perform medium pressure hyperbaric Oxygen therapy on me using a Biobarica 430 chamber.

 

I fully understand the pressurization and de-pressurization process and the associated risks thereof.

 

I acknowledge that the Biobarica system is considered Medium Hyperbaric Oxygen Therapy; and is not considered Hyperbaric Medicine.

 

I have been informed of the risks, benefits and foreseeable complications. I recognize that no guarantees or claims have been given to me with regards to the results of Medium Hyperbaric Oxygen Therapy. I acknowledge that medium Hyperbaric Oxygen therapy is an adjunctive therapy and should be used in conjunction with other primary modes of healthcare.

 

I understand that hyperbaric Oxygen therapy, and specifically Medium hyperbaric Oxygen Therapy is a complimentary therapy and does not constitute a treatment on its own. I understand that no guarantee of healing or cure of any disorder can be given and understand that Oxygenate (Pty) Ltd and any agent, employee, franchisee or otherwise nominated person can be held liable in the absence of healing.

 

Prior to each session, before entering the Biobarica 430 chamber, I undertake to inform the operator if I have a cold, otitis, coughing or other recent pulmonary infection, sinusitis or if I have other symptoms at the moment outside of the ordinary that I consider has to be reported.

 

Once I have entered the Biobarica 430 chamber I shall immediately inform the chamber operator if I suffer any earache or any other relevant medical symptoms.

 

I note that I should come to each session bathed and wounds dressed. I further note that I should be free of uncontrolled high blood pressure and dizziness and must have eaten within the hour previous to treatment if I am Diabetic.

 

I consent and will comply with the aforementioned conditions to enter a Biobarica 430 chamber. I have been given the opportunity to ask all questions pertaining to the session and all have been answered fully and satisfactorily in easy terms for my understanding.

 

BioBarica and Oxygenate (Pty) Ltd hereby indemnifies themselves, members, directors, instructors, employees, officers, franchisees and agents from all liability or responsibility whatsoever for bodily injury, damage to or loss of property or death, howsoever caused, and indemnifies and holds harmless the indemnified parties against any claim, loss, demands, liability, costs and expenses of whatsoever nature which may be made against any of them (including the costs incurred in defending or contesting any such claim) arising out of or connected with any agreement undertaken. I hereby confirm that I accept the above disclaimer.

Payment and Reimbursements, Cancellations and no shows. 

 

Once payment has been received by Oxygenate or any of its affiliated branches, NO CASH will be refunded for unused sessions. All endeavors will be made to accommodate clients preferred sessions times and locations. Packages expire within 3 months of purchase. Late cancellations and no shows (less than 24 hours) will be charged in full. Monthly package holders will be invoiced separately at standard rates. 

Frequently Asked Questions

What is a Hyperbaric Chamber?

A Biobarica (RevitalAir) 430 hyperbaric chamber is a vessel that creates an increase in atmospheric pressure (1,4 ATA) by using an air compressor wherein the occupant breathes Oxygen enriched air (90% Oxygen). This creates a physiological process known as "hyperoxia"; which is the level at which the oxygen carrying capacity within the body is optimised. In other words, it oxygenates the cells in one’s body.

 

A Biobarica (RevitalAir) 430 chamber does not cure, but rather accelerates the recovery process and creates an optimal environment wherein the body can heal itself.

What is hyperoxia?

 

Hyperoxia is created when a person breathes an increased Oxygen concentration within a pressurized environment above normal atmospheric pressure; which is considered one atmosphere (ATA).

 

When the process occurs, inspired Oxygen saturates the red blood cells and the excess dissolves in blood plasma, which raises the Oxygen tension in arteries, blood vessels and extracellular fluids.

​​

From this process, Oxygen is highly available to penetrate into all tissues and cells.

 

Once the process of hyperoxia has been created, a series of physiological benefits are triggered in the body. It is the co-adjuvant action of these favourable physiological events that assist in the improvement and management of many diseases.

What is the difference between HBOT and mHBOT?

The fundamental difference lies int the pressure. HBOT (Hyperbaric Oxygen therapy) technically refers to everything above 1 ATA (Atmosphere), but UHMS (Undersea & Hyperbaric Medical Society) states that for clinical hyperbaric therapy, the pressure needs to exceed 1,4 ATA whilst breathing near 100% Oxygen. 

 

mHBOT (medium hyperbaric Oxygen therapy) ranges between 1 ATA and 1,4 ATA whilst breathing Oxygen enriched air.

The Biobarica (RevitalAir) 430 chamber operates at 1,4 ATA and yields approximately 90% Oxygen enriched air at a flow rate of 10 liters per minute.

 

Hyperbaric therapy conducted at 1,4 ATA dramatically reduces claustrophobia and barotrauma events that frequently occur at higher pressures, but whilst still maintaining a critical level of hyperoxia.

 

Regarding safety, high-pressure environments carry a higher risk, while the use of mild pressure chambers significantly reduce the occurrence of adverse events, being considered 100% safe.

 

Is 1,4 ATA pressure efficient?

 

The theory developed by August Krogh demonstrates that 1,4 ATA is the optimal pressure needed for hyperoxia to occur within the body.

Why do we use 1,4 ATA?

 

1,4 ATA is considered a perfect balance between pressure efficacy and safety; hence yielding a highly efficient and very accessible environment. Pressures of greater than 1,5 ATA (considered "vessels under pressure"), require special facilities and additional safety considerations. Additionally, UHMS (Undersea & Hyperbaric Medical Society) states that for clinical hyperbaric therapy, the pressure needs to exceed 1,4 ATA whilst breathing near 100% Oxygen.


Is Oxygen used inside the chamber?

 

The Biobarica (RevitalAir) 430 chamber includes an auxiliary entryway to connect the occupant's mask to the external Oxygen concentrator which yields approximately 90% Oxygen at a flow rate of 10 litres per minute.

How is the air inside the chamber renewed?

 

The Biobarica (RevitalAir) 430 chamber uses an air compressor during the session, which sends approximately 120 litres of filtered air per minute to the inside of the cabin. Waste gasses are expelled through the safety valves, avoiding any concentration of gas. 

Can Oxygen become toxic?

 

Oxygen in high doses can become toxic if it is inhaled for long periods of time or excessive pressures. The protocols of the Biobarica (RevitalAir) 430 chamber do not approach the values of toxicity, making it impossible for a occupant to run any risk of Oxygen toxicity. 

 

The bottom end of the Oxygen toxicity curve typically only starts to become a risk at ± 1,57 ATA in excess of 5 hours of exposure. The Biobarica (RevitalAir) 430 chamber regulates at 1,4 ATA for 1 hour (max 1,5 hours) at a time. There is zero chance of Oxygen toxicity occurring. 

Is the Biobarica (RevitalAir) 430 chamber safe?

The Biobarica (RevitalAir) 430 chamber carries a class IIa CE certification by Det Norske Veritas (www.dnv.com), an international certification body and classification society with main expertise in technical assessment, advisory, and risk management. 

The Biobarica (RevitalAir) 430 chamber allows the use of cell phones or computers inside the cabin without risking safety. The equipment complies with international safety standards and has an extensive risk analysis to prevent any misuse

Does the chamber cause claustrophobia?

 

The Biobarica (RevitalAir) 430 chamber highly reduces the risk of claustrophobia as it can be opened from the inside by the occupant. The interior of the chamber is fairly spacious and the windows also provide ease for the occupant. 

What are the contraindications?

 

Contraindications can be considered relative and/or absolute. HBOT and mHBOT are not recommended with the presence any absolute contraindication.

 

Due to the pressure at which the Biobarica (RevitalAir) 430 chamber operates, relative contraindications are largely risk free but for due diligence purposes, it is asked that a doctor's clearance is obtained for any of the below relative contraindications.

  • Untreated Pneumothorax (absolute contraindication)

  • Certain anti-Cancer drugs i.e. doxorubicin, bleomycin and cisplatinum (absolute contraindication)

  • Chronic sinusitis and upper respiratory infections (relative contraindication)

  • Seizure disorders (relative contraindication)

  • Emphysema with CO2 intoxication (relative contraindication)

  • Uncontrolled high fever (relative contraindication)

  • History of thoracic surgery (relative contraindication)

  • History of ear surgery (relative contraindication)

  • Asymptomatic pulmonary blebs (relative contraindication)

  • Congenital spherocytosis (relative contraindication)

  • Significant pulmonary obstructive disease (e.g. asthma, emphysema, obstructive bronchial disease, bullous pulmonary disease etc) (relative contraindication)

  • Pregnancy

  • Ear blockages and/or ear conditions

  • Cystic Fibrosis

  • Stage 3 or 4 Cancer.


Can two people enter the Biobarica (RevitalAir) 430 chamber simultaneously?

 

Yes. This is very common in children with cerebral palsy or autism. The parent may accompany their child or teenager inside the Biobarica (RevitalAir) 430 chamber. The face mask is placed on the occupant and the person accompanying them may either request a secondary mask of merely inhale normal air.

How is an autistic occupant managed within the Biobarica (RevitalAir) 430 chamber?

 

The child is usually accompanied by a parent and may enter the Biobarica (RevitalAir) 430 chamber with an iPad or laptop (to watch a movie) or may read a book. The child wears the mask so they can inhale the Oxygen enriched air in order for hyperoxia to be created.

Is anything experienced in the Biobarica (RevitalAir) 430 chamber?

 

During the pressurization and depressurization process, the occupant may experience similar symptoms as flying in an aeroplane; mainly mild discomfort in the ears. The process of equalizing the ears is explained to the occupant prior to the session. There should be no discomfort during the session.

Can the Biobarica (RevitalAir) 430 chamber be entered in normal clothing?

 

The occupant may enter the chamber in any clothing they are most comfortable in. Shoes need to be removed prior to entry.

Is the Biobarica (RevitalAir) 430 chamber sterilized?

 

The CE certification indicates that the chamber needs to be cleaned once a day with Alcohol 70 (which is a mixture of 70% alcohol and 30% water). Between sessions, the chamber should be cleaned with disinfectant spray. 

Are there clinical studies regarding HBOT and mHBOT?

 

There are many clinical studies and treatment protocols pertaining to hyperbaric oxygen therapy. It is also mentioned by the FDA and many government agencies for many pathologies. BioBarica provides overall statistics of the entire Biobarica network of centres around the world; developing our own mHBOT protocols for various pathologies. We also share scientific studies developed to spread the knowledge among our professionals. 

What kind of Oxygen mask is used?

 

A closed mask with reservoir and clogged exhaust valves is recommended. This mask delivers 100% of available gas because the more the person inhales, the more effective the session is. 

Are longer sessions better?

 

Sessions of longer than 120 minutes may be done and are fully permitted and 100% safe; however the most cost effective ratio to the client are sessions of 60 to 90 minutes. The reasoning lies in Oxygen metabolism and the creation of hyperoxia within the body; once hyperoxia has been achieved, the tissue needs to metabolize the Oxygen before a further hyperoxic state will be beneficial.

Are shorter sessions useful?

 

Any exposure to Oxygen under pressure will be more beneficial than no exposure to Oxygen and/or pressure. That said, however, it is ideal for a state of hyperoxia to be created. This depends from individual to individual but on average takes upwards of 30 minutes.

How many times a week can the Biobarica (RevitalAir) 430 chamber be entered?


The Biobarica (RevitalAir) 430 chamber may be entered 7 days per week.


Does Biobarica provide training?

 

One of the most important elements that differentiates BioBarica are its extensive and comprehensive training programs.

 

Biobarica shares its knowlege base with its network for its members to operate their centers efficiently and in an economically sustainable manner. 

Does the Biobarica (RevitalAir) 430 chamber work for diving related pathologies?

 

No. The Biobarica (RevitalAir) 430 chamber has been designed specifically to create the critical environment for hyperoxia to occur. Treatment of diving accidents requires specific equipment designed to withstand far greater pressures.

 

In cases such as decompression sickness, underwater accidents, aviation and bio-warfare trauma; or where higher pressures are required for medical reasons, mHBOT is not a substitute for a hard chamber.

 

A comprehensive list of accredited hard chambers can be obtained from the Southern African Undersea and Hyperbaric Medical Association (www.sauhma.org).

How does the Biobarica (RevitalAir) 430 chamber work?

 

Just as sparkling water gas bubbles in a closed bottle are undetected until it is opened, physics explains that gas is diluted in the liquid when it is placed under pressure. The same happens when we breathe Oxygen in a cabin with augmented pressure: The Oxygen gas is diluted in plasma of the blood. 

Is Hyperbaric therapy new?

The original hyperbaric chamber was invented over 200 years ago, but a new category of chambers has been introduced to treat many more pathologies, making hyperbaric therapy much more accessible and user-friendly. 

Can the pressure of the Biobarica (RevitalAir) 430 chamber be altered?

 

The chamber operates at 1,4 ATA pressure. In the rare case of ear discomfort that is not relieved through equalizing or claustrophobia, the pressure may be lowered by opening the safety valves

How does the Biobarica (RevitalAir) 430 chamber compare to other soft chambers?

There are other cheaper brands of soft chambers which operate between 1,1 ATA and 1,3 ATA with the occupant breathing normal air. These cheaper models have a zipper and resemble a sleeping bag. This provides very little mobility for the occupant and are reportedly uncomfortable.

 

The biggest difference of the Biobarica (RevitalAir) 430 chamber is the efficacy of the therapy. The Biobarica (RevitalAir) 430 chamber creates a pressure of 1,4 ATA and allows the inhalation of 90% Oxygen, hence creating an environment whereby hyperoxia can occur but without the side effects of higher pressures.

The Biobarica (RevitalAir) 430 chamber carries a class IIa CE certification by Det Norske Veritas (www.dnv.com), an international certification body and classification society with main expertise in technical assessment, advisory, and risk management. 


Can the Biobarica (RevitalAir) 430 chamber chamber work all day?


Yes. The Biobarica (RevitalAir) 430 chamber can operate all day. Brief periods of five minutes per hour is sufficient, which is the same time between occupants. 

Can people who are paralysed or with reduced mobility enter the Biobarica (RevitalAir) 430 chamber?


Yes, the Biobarica (RevitalAir) 430 chamber is at a comfortable height and has a stretcher to easily slide an occupant with reduced mobility into the conveniently placed entrance which is on the side of the chamber.

What if the power goes out in the middle of a session?

 

There is nothing to worry about. The compressor will stop working and the occupant or chamber operator can simply depressurize the chamber normally to eject the air. The door can be easily opened and the occupant may exit.