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Interpretation Response #08-0266 ([International Biophysics Corporation (IBC)] [Mr. William R. Wilkinson])

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

Interpretation Response Details

Response Publish Date:

Company Name: International Biophysics Corporation (IBC)

Individual Name: Mr. William R. Wilkinson

Location State: TX Country: US

View the Interpretation Document

Response text:

January 8, 2009




Mr. William R. Wilkinson

Vice President of Engineering

International Biophysics Corporation (IBC)

2100 East St. Elmo Rd.

Austin, TX 78744

Ref. No. 08-0266

Dear Mr. Wilkinson:

This is in response to your October 13, 2008 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device your company calls the LifeChoice Portable Oxygen Concentrator (POC).

You state in your letter and a subsequent conversation with a member of my staff that the LifeChoice POC is a lightweight device that separates nitrogen from room air through the pressure swing absorption (PSA) process and stores the resultant concentrated oxygen gas for delivery to patients requiring supplemental oxygen. This device delivers the oxygen to the patient through the pulse dose delivery method. The maximum internally attainable pressure during the PSA cycle of the device is 22 psig (36.7 psia) over an operating temperature range of 5 °C to 40 °C (41 °F to 104 °F), with a maximum oxygen accumulator quantity of 45 mil per minute for operation in the pulse mode. The device can be powered by multiple power sources, including an internally captive, rechargeable lithium ion battery pack, AC to DC power adaptor, by an external DC to DC power adapter, or an external accessory lithium ion battery pack. The internally captive lithium ion battery consists of 8 rechargeable 2.2 amp-hour lithium ion cells with 0.3 grams of lithium content each, or a total of 5.2 grams of total equivalent lithium content (0.3 x 2.2 Ah x 8 cells), and no other hazardous materials. The external accessory battery module consists of two battery packs, each containing a total of 5.2 grams of total equivalent lithium content, or a total of 10.4 grams of total equivalent lithium content. The lithium ion 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 LifeChoice POC 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 280 kPa (40.6 psia) at 20 °C

(68 °F);

2. The lithium ion batteries used to operate the device are excepted in 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).

You should also note Federal Aviation Administration (FAA) approval is required before these electronic devices are used by passengers on board aircraft. The FAA published a final rule in the Federal Register regarding these devices on July 12, 2005 (70 FR 40156). 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.

In addition, even with FAA approval the air carrier ultimately determines what may or may not be carried on its aircraft. We suggest that you check with the air carrier to ensure that the LifeChoice portable oxygen concentrator may be carried.

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

Sincerely,

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

173.115(b)(1), 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