Health disclaimer

1. We do not make therapeutic claims

Oxivity describes what its equipment does — the pressure it reaches, the oxygen concentration it produces, how it filters air, how loud it is. We do not claim that using a chamber treats, cures, heals, relieves or prevents any named condition, and we ask our customers not to make those claims either when marketing sessions to their own clients.

If you have seen a claim about hyperbaric oxygen elsewhere and want to know whether it is supported, speak to a qualified health practitioner. Be sceptical of any supplier who tells you their equipment treats a specific disease.

2. This is not medical advice

The content on this website, including the questions and answers page, is general information about equipment. It is not a diagnosis, not a treatment recommendation and not a substitute for a consultation. Never delay seeking or disregard medical advice because of something you read here.

3. Speak to a practitioner before your first session

Hyperbaric sessions are not suitable for everyone. Get medical clearance first, particularly if any of the following apply to you:

• An untreated pneumothorax (collapsed lung) — this is an absolute contraindication.
• Severe chronic obstructive pulmonary disease or other significant respiratory conditions.
• Any seizure disorder, including epilepsy.
• Ear or sinus conditions, recent ear surgery, or difficulty equalising ear pressure.
• An active upper-respiratory infection, cold or blocked sinuses.
• Cardiac conditions, or uncontrolled high blood pressure.
• Pregnancy — treat this as requiring a doctor's sign-off, without exception.
• Use with children, which should be discussed with a healthcare provider given differences in ear anatomy and in the ability to communicate during a session.
• Any medication whose interaction with pressurised oxygen you have not checked.
• Significant claustrophobia or anxiety in enclosed spaces.

Every Oxivity installation ships with a client screening template. Operators should complete screening before a client's first session, not after.

4. Known risks

• Ear and sinus barotrauma. Pressure change can cause discomfort or injury to the ears and sinuses, particularly if you cannot equalise.
• Fire. Oxygen-enriched environments carry a genuine fire risk if equipment, materials and procedures are not managed correctly. Australia's Therapeutic Goods Administration has published a safety alert about fire risk during the use of hyperbaric chambers. Follow the operating procedure, keep prohibited materials out of the chamber, and complete the electrical safety checks.
• Claustrophobia and anxiety. Some people find an enclosed, pressurised space distressing.
• Serious but rare events. Injuries including barotrauma to the lungs and gas embolism have been reported in hyperbaric devices internationally. Correct operation and proper screening reduce, but do not eliminate, risk.

5. Operating safely

• Only operate a chamber after completing the Oxivity operational walkthrough.
• Never leave a person in a chamber unattended.
• Maintain two-way communication with the occupant throughout the session.
• Know where the emergency power switch is and how to depressurise.
• Test the residual current device monthly, with the equipment not in operation.
• Follow the manufacturer's operating manual in full.

6. Regulatory position

Australia

Whether a hyperbaric chamber is regulated as a medical device under the Therapeutic Goods Act 1989 depends on the intended purpose and the claims made about it. Oxivity supplies equipment for general wellness and recovery use and makes no therapeutic claims. If you intend to use a chamber therapeutically, or to advertise therapeutic outcomes to your own clients, additional obligations under the Therapeutic Goods Advertising Code and the ARTG may apply to you. Confirm your position with the TGA or your own compliance adviser before you begin — and talk to us first, because the answer may change which equipment is appropriate.

New Zealand

Medical devices supplied in New Zealand may require notification to the WAND database administered by Medsafe, again depending on intended purpose. The Fair Trading Act 1986 also prohibits misleading representations about what a product does.

United States

The US Food and Drug Administration regulates hyperbaric oxygen therapy devices and has cleared them for a specific list of indications. General wellness and recovery use is not among them, and the FDA has publicly cautioned consumers against hyperbaric marketing for conditions it has not cleared. Oxivity equipment is not FDA-cleared, is not offered for the treatment of any condition, and is not marketed into the United States.

7. Your responsibilities as an operator

If you operate a chamber commercially, you are responsible for screening your own clients, for the claims you make to them, for the qualifications and supervision arrangements applying in your state or profession, and for holding appropriate insurance. Oxivity supplies equipment, documentation and training on that equipment. We do not provide clinical advice, treatment protocols or regulatory approval.

8. If something goes wrong

Stop the session, depressurise following the documented procedure, and seek medical attention if anyone is unwell or injured. Then contact us at hello@oxivitywellness.com.au so we can investigate the equipment.