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Interpretation Response #11-0285 ([Philips Respironics] [Mr. Joseph E. Olsavsky])

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

Interpretation Response Details

Response Publish Date:

Company Name: Philips Respironics

Individual Name: Mr. Joseph E. Olsavsky

Location State: PA Country: US

View the Interpretation Document

Response text:

December 22, 2011

Mr. Joseph E. Olsavsky
Philips Respironics
1740 Golden Mile Highway
Monroeville, PA 15146

Ref. No.: 11-0285

Dear Mr. Olsavsky:

This responds to your November 8, 2011 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen concentrator (POC). Specifically, you inquire about obtaining Federal Aviation Administration (FAA) approval to allow a passenger to carry the POC aboard an aircraft. According to your letter, the POC (trade name SimplyGo) is a device that is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. The maximum operating pressure of the SimplyGo POC is 27 pounds per square inch (psi), with a safety relief valve with a lift pressure of 6.5 psi gauge in the gas circuit. The SimplyGo POC is powered by multiple sources, including AC or DC power, and a rechargeable lithium-ion battery pack. For the SimplyGo POC powered by the BAK battery pack, the lithium-ion cells have a lithium content of 0.66 grams per cell, or 7.92 grams of aggregate equivalent lithium content for the battery pack. For the SimplyGo POC powered by the Panasonic battery pack, the lithium-ion cells have a lithium content of 0.630 grams per cell, or 7.56 grams of aggregate equivalent lithium content for the battery pack. The lithium-ion battery packs are types proven to meet the appropriate tests in the United Nations (UN) Manual of Tests and Criteria, and the battery packs are 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 SimplyGo 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 a SimplyGo POC as described above, approval by the 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 directly to ensure that the SimplyGo POC may be carried.

I hope this satisfies your inquiry. Please contact us if we can be of further assistance.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

172.102 SP 188, 175.10

Regulation Sections

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