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Interpretation Response #05-0215 ([SeQual Technologies, Inc.] [Ms. Pamela J. Jackson])

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

Interpretation Response Details

Response Publish Date:

Company Name: SeQual Technologies, Inc.

Individual Name: Ms. Pamela J. Jackson

Location State: CA Country: US

View the Interpretation Document

Response text:

Nov 30, 2005

 

Ms. Pamela J. Jackson                        Reference No. 05-0215
Director of Marketing
SeQual Technologies, Inc.
11436 Sorrento Valley Road
San Diego, CA 92121

Dear Ms. Jackson:

This is in response to your August 30, 2005 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device that your company calls the Eclipse Oxygen System.

You state in your letter that the Eclipse Oxygen System is a device that separates oxygen from ambient air for delivery to patients who require supplemental oxygen therapy. This device consists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for continuous flow or pulse delivery. The process by which oxygen is separated is called Pressure Swing Absorption (PSA). The maximum pressure of the oxygen exerted within the Eclipse Oxygen System packaging is 23.7 psia during normal operation at 20 °C. The device can be powered by multiple power sources, including AC or DC power, an AC adapter, rechargeable lithium ion batteries, and an automobile cigarette lighter adapter. The battery pack consists of 24, 2.2 ampere-hour lithium ion cells, and the total equivalent lithium content of the battery pack is 15.8 grams. 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 Eclipse Oxygen System portable oxygen concentrator is not currently subject to the HMR because: (1) the pressure of the oxygen in the device does not exceed 40.6 psia at 20 °C; (2) the lithium ion battery used to operate the device is excepted from the HMR ( 173.185(c)(2)); (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).

In accordance with the 2005-2006 Edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air, your device is regulated as a Class 9 material when transported as cargo onboard passenger and cargo aircraft. However, the device may be authorized for transportation onboard passenger aircraft as consumer electronic devices containing lithium ion
batteries with up to 25 grams of equivalent lithium content when carried by passengers or crew for personal use and protected so as to prevent short circuits.

In addition, 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).

You may be interested to know that, in a notice of proposed rulemaking published under Docket HM-224E on December 15, 2004 (69 FR 75207), the Pipeline and Hazardous Materials Safety Administration has proposed to eliminate the 25-gram exception for lithium batteries found under § 173.185(c)(2) of the HMR. Please refer to our website at hazmat.dot.gov under the Rules and Regulations icon, in the rulemaking and Federal Register Notices section.

I trust this satisfies your inquiry.

Sincerely,

 

John A. Gale
Chief, Standards Development
Office of Hazardous Materials Standards

173.115, 173.185, 175.10

Regulation Sections

Section Subject
173.115 Class 2, Divisions 2.1, 2.2, and 2.3-Definitions
173.185 Lithium cells and batteries
175.10 Exceptions for passengers, crewmembers, and air operators