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Interpretation Response #08-0237 ([OxLife LLC] [Mr. Stuart H. Bassine])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: OxLife LLC

Individual Name: Mr. Stuart H. Bassine

Location State: NC Country: US

View the Interpretation Document

Response text:

December 10, 2008






Mr. Stuart H. Bassine

President and Senior Technical Engineer

OxLife LLC

141 Twin Springs Rd.

Hendersonville, NC 28792

Ref. No. 08-0237

Dear Mr. Bassine:

This is in response to your September 25, 2008 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device your company calls the Oxlife Independence Oxygen Concentrator.

You state in your letter, supporting documentation, and a subsequent conversation with a member of my staff that the device is a portable oxygen concentrator intended to supply concentrated oxygen for adult patients requiring supplemental oxygen. This device consists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for continuous flow or pulse delivery. The process by which oxygen is provided is called molecular sieve absorption technology. The maximum pressure of the oxygen exerted within the device is less than 17 psia during normal operation at a range from -10° C to 131° C. The device provides approximately 90% oxygen to the patient on continuous to 3 and on a conserver flow basis at an equivalent rate of 1.0 liters per minute to 6.0 liters to minute. The device can be powered by multiple power sources, including AC, DC or rechargeable battery power. The battery pack consists of 7 cells with 1.14 grams of lithium content each, or a total of 7.98 total equivalent lithium content, and no other hazardous materials. The lithium polymer rechargeable battery pack has been tested pursuant to the United Nations Manual of Tests and Criteria and is packaged in a manner to prevent short circuits when offered for transport or carried onboard passenger aircraft. You ask whether this device is regulated as a hazardous material under the HMR.

Based on the information provided, the Oxlife Independence Oxygen Concentrator is not currently subject to the HMR because it meets the following criteria:

1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 °C;

2. The lithium polymer battery used to operate the device meets the requirements of the HMR;

3. The portable oxygen concentrator contains no other materials subject to the HMR; and

4. The battery pack is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals).

It should also be noted that Federal Aviation Administration (FAA) approval is required before these electronic devices are used by passengers on board aircraft. For further assistance, you may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch (AFS-220) by phone at (202)-267-3732 or email at david.catey@faa.gov.

I hope this satisfies your inquiry. If we can be of further assistance, please contact us.



Sincerely,

Susan Gorsky

Acting Chief, Standards Development

Office of Hazardous Materials Standards

173.115, 173.185

Regulation Sections

Section Subject
173.115 Class 2, Divisions 2.1, 2.2, and 2.3-Definitions
173.185 Lithium cells and batteries