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Interpretation Response #11-0295 ([Precision Medical, Inc.] [Mr. Jim Parker])

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

Interpretation Response Details

Response Publish Date:

Company Name: Precision Medical, Inc.

Individual Name: Mr. Jim Parker

Location State: PA Country: US

View the Interpretation Document

Response text:

January 11, 2012

Mr. Jim Parker
Quality Manager
Precision Medical, Inc.
300 Held Drive
Northampton, PA 18067

Ref. No.: 11-0295

Dear Mr. Parker:

This is in response to your November 29, 2011, letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator (POC). According to your letter, the POC (common name Easy Pulse) is a portable device that produces an oxygen enriched gas mixture by removing nitrogen from the air. The maximum operating pressure of the POC is 14.5 psi. The POC is powered by multiple sources, including AC or DC power, and a rechargeable lithium-ion battery pack with less than 6.24 g aggregate equivalent lithium content. The lithium-ion battery pack is a type proven to meet the appropriate tests in the United Nations Manual of Tests and Criteria, and the battery pack 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 under the HMR.

Based on the information provided in your letter, the Easy Pulse POC is currently not subject to the HMR because: (1) the pressure of the oxygen in the device does not exceed 200 kPa gauge (29.0 psig/43.8 psia) at 20 °C (68 °F); (2) the lithium-ion battery pack used to operate the device is excepted from the HMR under § 172.102(c)(1), Special provision 188; (3) the POC 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 (e.g., by the effective insulation of exposed terminals).

Although the exception in § 175.10(a)(18) of the HMR would apply to a passenger carrying an Easy Pulse POC as described above, approval by the Federal Aviation Administration (FAA) is required before it may be used by a passenger onboard an aircraft. The FAA published a final rule on July 12, 2005 (70 FR 40155) regarding these devices. 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, an air carrier ultimately determines what may or may not be carried on its aircraft.

We suggest that you contact the airlines to ensure that the Easy Pulse POC may be carried.

I hope this information is helpful. If you have further questions, please contact this office.

Sincerely,

Ben Supko
Acting Chief, Standards Development
Office of Hazardous Materials Standards

172.102 SP 188, 175.10(a)(18)

Regulation Sections

Section Subject
173.185 Lithium cells and batteries
175.10 Exceptions for passengers, crewmembers, and air operators