Interpretation Response #08-0032 ([Invacare Corporation] [Ms. Carroll Martin])

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

Interpretation Response Details

Response Publish Date: 06/16/2008

Company Name: Invacare Corporation

Individual Name: Ms. Carroll Martin

Location State: OH Country: US

View the Interpretation Document

Response text:

June 16, 2008

Ms. Carroll Martin

Regulatory Affairs Manager

Invacare Corporation

One Invacare Way,

Elyria, OH 44035

Ref. No.: 08-0032

Dear Ms. Martin:

This is in response to your January 30, 2008 letter and subsequent conversation with Ben Supko of my staff regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device that your company calls the Invacare Portable Oxygen Concentrator XPO100 and an external battery module.

On August 9, 2007, PHMSA amended the HMR to tighten the safety standards for transportation of lithium batteries, including both primary (non-rechargeable) and secondary (rechargeable) lithium batteries (HM-224C & HM-224E; 72 FR 44929). A copy of the rulemaking is enclosed. Effective January 1, 2008, the Pipeline and Hazardous Materials Safety Administration revised and relocated the 8-gram exception for small lithium batteries formerly found under § 173.185(b)(2) of the HMR. New requirements applicable to the Invacare XPO100 and external battery module, described in your letter, are provided in Special Provision 188 (§ 172.102).

In your letter, you indicate that the Invacare XPO100 portable oxygen concentrator and external battery module meet the following criteria:

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

(2) the cells contain not more than 1.5 grams of lithium equivalent content;

(3) the lithium ion batteries contain an aggregate equivalent lithium content of not more than 8g;

(4) the device contains no other materials subject to the HMR; and

(5) the batteries are fully contained in equipment and packaged in a manner to preclude sparks or the generation of a dangerous quantity of heat.

Based on the information provided, the Invacare XPO100 portable oxygen concentrator and external battery module meet Special Provision 188. Provided they continue to meet the requirements established by Special Provision 188, you are not otherwise subject to the HMR.



You should also note that Federal Aviation Administration (FAA) approval is required before these electronic devices may be 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). A copy of the rulemaking is enclosed.

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 Invacare XPO 100 portable oxygen concentrator and external battery module may be carried.

I hope this information is helpful. If you have further questions, please do not hesitate to contact this office.

Sincerely,

Edward T. Mazzullo

Director

Office of Hazardous Materials Standards

172.102 175.10

Regulation Sections