Interpretation Response #10-0163 ([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:
February 10, 2011
Ms. Pamela J. Jackson
Senior Director, Government and Military
SeQual Technologies, Inc.
11436 Sorrento Valley Road
San Diego, CA 92121
Reference No. 10-0163
Dear Ms. Jackson:
This is in response to your letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device that your company calls the SAROS" Oxygen System.
You state that the SAROS" Oxygen System is a device that separates oxygen from ambient air through a process called Pressure Swing Absorption (PSA). Your product was developed in cooperation with the US Army Medical Materiel Command to support the oxygen needs of patients on a battlefield. This device consists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for continuous flow or pulse delivery. The maximum pressure of the oxygen exerted within the SAROS" 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 auxiliary DC power adapter for automotive applications. The battery pack consists of 16, 1.5 ampere-hour lithium ion cells, and the total equivalent lithium content of the battery pack is 7.20 grams or 86 Watt-hours. The lithium ion cells and battery pack have 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 SAROS" 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 280 kPa absolute (40.6 psia) at 20 °C (68 °F); (2) the lithium ion battery used to operate the device is excepted from the HMR under § 172.102(c)(1), Special provision 188; (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).
Although the exception in § 175.10(a)(17) would apply to a passenger carrying a SAROS" Oxygen System as described above, the approval of 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; copy enclosed) 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 SAROS" Oxygen System may be carried.
I trust 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(a)(17)