Frequently Asked Questions (FAQ’s)

1.  .    What is the R15™ device?

The R15 Emergency Oxygen device is the only commercially available portable emergency oxygen product that is safe to use in ALL public places and that does not require certification, training or specialized storage. This device is cleared by the Food and Drug Administration (FDA) to produce instant, non-pressurized oxygen for emergency situations. Once the R15 device is activated, oxygen flows to a victim of a breathing emergency at a therapeutic rate of 6 liters per minute for 15 minutes. The R15 device requires no electric or battery source and no maintenance. It has a 2-year shelf life, at which point a replacement R15 device is ordered.

2.    How does the R15 device work?

Once activated, the R15 device generates 100% humidified emergency oxygen for 15 minutes. Oxygen is created after you turn a lever on the R15 device by combining hydrogen peroxide washing soda powder with water and a catalyst. The oxygen flow rate of 6 liters per minute meets FDA criteria for emergency oxygen delivery.

3.    What are the R15 device advantages over an oxygen gas cylinder?

Oxygen gas cylinders cannot be openly stored in public spaces due to their very high pressures and explosive potential. They must be stored in steel, fire retardant cabinets capable of withstanding 500°F temperatures for 30 minutes. Oxygen gas cylinders require a prescription for use and are not simple to use particularly in an emergency. Only people who have been properly certified may operate an oxygen cylinder. The Oxygen cylinder also must be inspected on a regular basis to ensure the pressure and valves are up to FDA requirements and local safety codes.

In contrast to pressurized oxygen cylinders, the R15 device produces oxygen by chemical means under very low pressure and may be stored on an open shelf or standard cabinet. The R15 device is cleared by the FDA as an over-the-counter product to be used by untrained bystanders and without a prescription.

4.    Why is the R15™ Portable Emergency Oxygen device so important?

Every second counts during a breathing emergency. Oxygen loss for less than 15 minutes can injure a victim, leading to brain damage, organ failure or death. Before the R15 device was invented, there was no ACCESSIBLE & SAFE way for bystanders to deliver emergency oxygen to victims of breathing emergencies in a public place. The R15 device is NOT a pressurized oxygen cylinder and not an explosion hazard so it can be safely stored and used anywhere. Because the R15 device is cleared by FDA for use by anyone without training or certification, it provides an additional level of life support.

About the size of a large briefcase, the R15 device is portable so it may be carried to a victim of a breathing emergency. The R15 device will provide uninterrupted emergency oxygen for 15 minutes which is about twice as long as the average response time of emergency medical services (EMS) arrival in the United States.

5.    When would you use the R15 device?

The R15 device may be used for any breathing emergency, including cardiac arrest. Following are some examples of the events that can lead to breathing emergencies where the R15 device is designed to be used:

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When someone is struggling to breathe, bystanders should immediately call 911 and then use the R15 device to support the victim until EMS arrives.  

6.    Why is emergency oxygen so important during a medical emergency?

Life-threatening medical emergencies can be accompanied by low tissue oxygen levels (not enough oxygen in the victim’s blood). Even short periods of oxygen loss can lead to tissue damage, and coma or death can occur in less than fifteen minutes. Bystander delivery of emergency oxygen with the R15 device can provide additional life support until EMS arrives.

7.    How does the R15 device reduce exposure to potential “premises liability”?

The R15 device is a unique safety technology designed and cleared by FDA for bystander use – like an automatic external defibrillator (AED). Incorporating the most up-to-date safety equipment into corporate protocols is a best practice that may help reduce liability when the event occurs on company property.

8.    Where do you place the R15 device?

The R15 device should be prominently placed in highly visible public areas for rapid access during a medical emergency. It is recommended that the R15 devices are situated in locations no farther than a 1 to 3 minute walk from a main public area. Example locations include: near existing safety equipment (e.g. AEDs, fire extinguishers, first aid kits), in locker rooms, restaurant or bar areas, lobbies by the security guard or elevator. Select multiple sites so responders do not have to go far to find an R15 device during a medical emergency.

9.    Who can use an R15 device?

Any bystander may use the R15 device to help someone who is experiencing a breathing emergency. 

10. Can anyone buy an R15 device?

Yes – the R15 device does not require a prescription or special training. It is sold online at rapidoxygen.com as well through select distributors.

11. How much does the R15 device cost?

The retail price of the R15 device is $395. The R15 device may also be rented at a cost of $17 per month for a term of 2 years (24 months). Call for quantity discount pricing.

12. Is the R15 device safe to use on children?

Yes

13. Why is notifying the local EMS/911 so important?

According to EMS.gov, “911, the universal number to call for emergency help nationwide, is a proven, life-saving service to the public.” By contacting 911 as soon as a medical emergency occurs bystanders provide the greatest chance for survival to victims of medical emergencies. The R15 device supports the 911 vision to “transition to more advanced ways for members of the public to access emergency response services.” The R15 device should be used on breathing emergency victims until EMS arrives. 

14. Once used, how do I dispose of the R15 device?

Once used, wait an hour to ensure the oxygen flow has fully stopped after which the R15 device can be disposed through your normal trash removal service.

15. Does the oxygen flow longer than the 15 minutes?

After the initial 15 minutes delivery at 6 liters per minute oxygen may continue to flow but at a significantly reduced level for up to an hour.  If EMS has not arrived in 15 minutes after applying an R15 device to a victim, a second R15 device should be activated for the victim.

16. Can the R15 device float?

Yes – in fact, the R15 device is ideal in water emergencies while you wait for the EMS to arrive. Many pool and ocean rescues may require the R15 device to be brought into the water to help give the victim access to emergency oxygen while they are rescued.

17.  Can the R15 device be stopped and re-started?

The R15 device is a “single patient use” use medical device. Once activated, it cannot turn off, cannot be re-started, and must be removed from service and replaced with a functional R15 device.

18. Why does the R15 device have to be replaced every two years even if it isn't used?

 Oxygen is a drug produced by the R15 device from a chemical that degrades over time. FDA labeling mandates expiration dates in keeping with performance potency of the product.

19.  Is the R15 device flammable and will it explode?

The R15 device is designed to be non-explosive by eliminating a pressurized oxygen cylinder. The R15 device case can ignite after repeated attempts with an open flame at extreme temperature – as in the event of a facility fire. Due to its low operating pressure and safety relief valve, however, it will not explode as a pressurized oxygen cylinder can.

20.  Can emergency oxygen cause harm to a victim of a breathing emergency?

The R15 device provides 15 minutes of oxygen-enriched air at 6 liters/minute to the face mask provided with the R15 device. This therapeutic level of oxygen is intended to provide relief from the effects of low oxygen levels in the blood and is not known to cause harm (e.g. depressed respiratory drive). Emergency oxygen delivery is intended to provide beneficial life support, particularly when made available by a bystander before EMS arrives.

21. Does the victim need to breath in to draw Oxygen out of the R15?

No. The R15 produces or pushes a constant positive flow of Oxygen at a minimum rate of 6 liters per minute for at least 15 minutes.  This is considered passive inflation of Oxygen enriched air that occurs by replenishing and replacing the exhaled air contained in the mouth, which contains low oxygen and high carbon dioxide from prior breaths.  

22. What happens after 15 minutes? Does the R15 just shut off or run out of Oxygen?

No. The R15 continues producing Oxygen beyond the 15 minutes, but at lower flow rates thereafter.  The R15 actually produces Oxygen for approximately 45 minutes as the Oxygen flow rate slowly declines following 15 minutes of usage at a constant 6 liters per minute flow rate (“Emergency Oxygen” flow rate as defined by FDA Guidelines).  The R15 produces a total of 150 liters of Oxygen over the approximate 45-minute period.

23. Does the R15 prevent air contaminants from entering the victim if the mask is on the victim?

Although the R15 is a self-contained system that produces Oxygen by chemical means and does not utilize or incorporate ambient air, the air ports in the mask included with the R15 mask may allow ambient air to enter.  The R15 Oxygen connecting tube, however, may be detached from the R15’s accessory mask and fitted to go on an Oxygen port on a bag-mask resuscitator to provide Oxygen enrichment of the inspired air, similar to an oxygen cylinder.

 24. Can I replace the R15 mask with a more industry or usage mask?

Yes.  Any mask can be attached to the tube integrated with the R15 itself in order to accommodate third party masks.

 25. What is international product code for medical Oxygen producing device?

SIC code 504735.

 26. What is international product code for a medical Oxygen producing device similar to the R15?

The SIC code for a medical Oxygen producing device is 504735.

 

27. What is FDA’s code for portable chemical Oxygen generator’s similar to the R15?

The FDA code for a portable Oxygen generator is CAW.

 28. What does it mean when we say our R15 Emergency Oxygen is FDA cleared for “OTC”?

In order for medical devices to be legally marketed (sold) in the United States, they are required to be “cleared” by the FDA. The R15 Emergency Oxygen is FDA cleared for over-the-counter (OTC) use. FDA indicates that “Oxygen generator and oxygen equipment intended for emergency use may be marketed for over-the-counter (OTC) distribution, provided such devices deliver a minimum flow rate of 6 liters of oxygen per minute for a minimum of 15 minutes.”  

Devices which do not meet the minimum flow rate criteria of 6 liters of oxygen per minute, maintained for 15 minutes, are regarded as prescription devices and must bear the prescription legend, provided that these devices have a minimum total oxygen delivery capacity of 90 liters.

Over-the-counter (OTC), in this context, refers to drugs or medical devices that are sold directly to a consumer without a prescription. OTC drugs/medical devices are defined as safe and effective for use by the general public without seeking treatment by a health professional.

 Examples of other products the FDA have cleared as OTC include: blood pressure cuffs, thermometers, pulse oximeters, reading glasses, etc. 

 Source:https://www.fda.gov/drugs/types-applications/drug-applications-over-counter-otc-drugs

29. Can the mask be removed from the hose so one can attach the hose to a bag valve mask (BVM)? 

Yes, the connecting tube is easily removed from the mask and attached to the oxygen port on a BVM*. 

*BVM is not sold through Rapid Oxygen. BVM is an airway apparatus used to cover the patient's nose and mouth in order to ventilate the lungs mechanically by squeezing a reservoir of oxygen or air.