05:48:31P.m. 01-08-2009 213

202 366 7041

@

U.5. Depanment

of Transportataon

Pipeline and Hazardoos Materials

Safety Mministration

!200 New Jerssy Ave., SE

Washrngton, DC 20590

JAN 0 I 2009

Mr. William R. Wilkinson

Vice President of Engineering

International Biophysics Corporation 0BC)

2100 East St. Elmo Rd.

Austin, TX787M

Ref. No.08-0266

Dear Mr. Wilkinson:

This is in response to your October 13, 2008 letter regarding the applicability of the Hazardous

Materials Regulations (HMR; 49 CFR Parts 100-180) to a device your company calls the

LifeChoice Portable Oxygen Concentrator (POC).

You state in your letter and a subsequent conversation with a member of my staff that the

LifeChoice POC is a lightweight device that separates nitrogen from room air through the pressure

swing absorption (PSA) prooess and stores the resultant concentrated oxygen gas for delivery to

patients requiring supplemental oxygen. This device delivers the oxygen to the patienthrough the

pulse dose delivery method. The maximum interndlly attainable pressure during the PSA cycle of

the device is 22 psig (36.7 psia) over an operating temperature range of 5 oC to 40 "C (41 'F to 104

"F), with a maximum oxygen accumulator quantity of 45 mil per minute for operation in the pulse

mode. The device can be powered by multiple power sources, including an internally captive,

rechargeable lithium ion battery pack, AC to DC power adaptor, by an external DC to DC power

adapter, or an external accessory lithium ion battery pack. The internally captive lithium ion battery

consisls of 8 rechargeable2.2 amp-hour tithium ion cells with 0.3 grams of lithium content each, or

a total of 5.2 glarns of total equivalent lilhium content (0.3 x2.2 Ah x 8 cells), and no other

hazardous materials. The external accessory battery module consists of two battery packs, each

containing a total of 5.2grams of total equivalent lithium content, or a total of 10.4 grarns of total

equivalent lithium content. 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 LifeChoice POC is not currently subjecto the HMR

because it meets the following criteria:

l. The pressure of the oxygen in the device does not exceed 280 kPa (a0.6 psia) at 20 "C

(68 "F);

2. The lithium ion batteries used to operate the device are excepted in the HMR;
05r48:52p.m. 01-08-2009

3. The portable oxygen concentmtor contains no other materials subject to the HMR; and

4. The battery pack is packaged in a rnanner to preclude it from creating sparks or generating a

dangerous quantity of heal (for example, by the effective insulation of exposed terminals).

You should also note Federal Aviation Administration (FAA) approval is required before thesc

electronic devices are used by passengers on board aircraft. The FAA published a final rule in the

Federal Registeregarding these devices on July 12,2005 (70 FR 40156). For further assistance,

you may contact Mr. Dave Catoy, Aviation Safety Inspector for the FAA Air Carrier Operations

Branch (AFS-220) by phone at (202)-267-3732 or email ar dqy1.d.!4lgJ@,tac€!l.

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 LifeChoice

portable oxygen concenkator may be carried.

I hope this satisfies your inquiry. If we can be of further assistance, please contact us.

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

3t3

202 366 7041