Interpretation Response #15-0002 ([Invacare Corporation] [Ms. Carol Vierling])

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

Interpretation Response Details

Response Publish Date: 02/20/2015

Company Name: Invacare Corporation

Individual Name: Ms. Carol Vierling

Location State: OH Country: US

View the Interpretation Document

Response text:

February 20, 2015

Carol Vierling
Acting Regulatory Affairs Manager
Invacare Corporation
One Invacare Way
P.O. Box 4028
Elyria, OH 44036

Ref. No.: 15-0002

Dear Ms. Vierling:

This responds to your December 30, 2014 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 approval from the Pipeline and Hazardous Materials Safety Administration (PHMSA) and the Federal Aviation Administration (FAA) to allow a passenger to carry and operate the POC on board an aircraft.

According to your letter, the POC (trade name Invacare XPO₂) is a device for use by patients requiring high concentrations of oxygen on a supplemental basis. The device in question is a modified version of an earlier model of the Invacare XPO₂ POC that is currently listed in Special Federal Aviation Regulation 106, "Rules for Use of Portable Oxygen Concentrator Systems on Board Aircraft"(SFAR 106) and approved for use on board aircraft. The modified version of the Invacare XPO₂ POC for which you seek approval has a maximum operating pressure of less than 21.0 pounds per square inch (psia). It is powered by multiple sources, including AC or DC power, a captive internal lithium ion battery pack, and a rechargeable external accessory lithium ion battery pack. Both the captive internal lithium ion battery pack and the rechargeable external accessory lithium ion battery pack have a Watt-hour (Wh) rating of 83.5 (2.9 ampere-hour (Ah) x 3.6 volts (V) x 8 cells). Both the captive internal and the rechargeable external accessory lithium ion battery packs meet the appropriate testing requirements of the United Nations Manual of Tests and Criteria, and both battery packs are packaged in a manner to prevent short circuits. You ask whether the modified version of the Invacare XPO₂ POC is authorized under the HMR to be carried on board an aircraft.

Based on the information provided in your letter, the modified version of the Invacare XPO₂ POC is not subject to the HMR as a Division 2.2 non-flammable gas, the captive internal and the rechargeable external accessory lithium ion battery packs used to power the device conform to § 175.10(a)(18), and the POC contains no other hazardous materials. Therefore, in accordance with HMR § 175.10(a)(18), the modified version of the Invacare XPO₂ POC is authorized to be carried on board an aircraft by passengers or crew members.

Please note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR, the provisions of SFAR 106 apply and are under the purview of the FAA. This response satisfies only one requirement in the FAA approval process before a POC may be carried and operated on board an aircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at (202) 267-7480 for questions regarding FAA's approval process.

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

Sincerely,

Duane A. Pfund
International Standards Coordinator
Standards and Rulemaking Division

175.10(a)(18)

Regulation Sections