{"operation":"document","citation":"11-0072","title":"AirSep Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-04-20","effective_on":null,"summary":"11-0072 response to AirSep Corporation concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0072.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0072.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0072","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110072.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration\nAPR 20 2011 1200 New Jersey Ave, SE\nWashington, D.C. 20590\nMr. Richard W. Boerdner\nProduction Manager\nAirSep Corporation\n401 Creekside Drive\nBuffalo, NY 14228-2085\nReference No. 11-0072\nDear Mr. Boerdner:\nThis responds to your March 25,2011 letter and subsequent telephone conversation with a\nmember ofmy staff regarding the applicability ofthe Hazardous Materials Regulations (HMR; 49\nCFR Parts 171-180) to a portable oxygen concentrator (POC) for purposes ofobtaining FAA\napproval to allow a passenger to carry the POC aboard an aircraft. According to your letter, the\nPOC (trade name Focus) is a device that separates oxygen from ambient air through a process\ncalled Pressure Swing Absorption (PSA). The device uses oxygen conserving technology to\nprovide supplemental oxygen to persons with medical needs. The maximum operating pressure\nofthe POC is 39 psi a at 20°C. The POC is powered by multiple sources, including AC or DC\npower, and a rechargeable lithium-ion battery pack. The battery pack consists of four 2.6 Ah\nlithium-ion cells equating to an equivalent lithium content of 0.78 g per cell and 3.12 g aggregate\nequivalent lithium content for the battery pack (38.48 Wh). The lithium-ion battery pack is a type\nproven to meet the appropriate tests in the United Nations Manual of Tests and Criteria, and the\nbattery pack is packaged in a manner to prevent short circuits when offered for transport or\ncarried onboard passenger aircraft. You ask whether this device is regulated under the HMR.\nBased on the information provided in your letter, the Focus POC is currently not subject to the\nHMR because: (1) the pressure ofthe oxygen in the device does not exceed 200 kPa gauge (29.0\npsigl43.8 psia) at 20°C (68 OF); (2) the lithium-ion battery pack used to operate the device is\nexcepted from the HMR under § 172.1 02( c)( I), Special provision 188; (3) the POC contains no\nother materials subject to the HMR; and (4) the battery pack is packaged in a manner to preclude\nit from creating sparks or generating a dangerous quantity ofheat (e.g., by the effective insulation\nofexposed terminals).\nAlthough the exception in § 175.1O(a)(18) ofthe HMR would apply to a passenger carrying a\nFocus POC as described above, approval by the Federal Aviation Administration (FAA) is\nrequired before it may be used by a passenger onboard an aircraft. The FAA published a final\nrule on July 12,2005 (70 FR 40155) regarding these devices. For further assistance, you may\ncontact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch\n(AFS-220) by phone at (202)-267-3732 or email at david.catey((v,faa.gov. In addition, even with\n\n<<<PAGE 2>>>\n\nFAA approval, an air carrier ultimately determines what mayor may not be carried on its aircraft.\nWe suggest that you contact the airlines to ensure that the Focus POC may be carried.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nBen Supko\nActing Chief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nAirSep Corporation\n401 Creekside Drive\nBuffalo, New York 14228-2085\n(716) 691-0202\nIndustrial 8. Medical Air Separation Equipment Fax (716) 691-4141\nDer I<IYJdeveJ1\n<§1'13, (/5\nMr. Charles Betts\n~ 175 . J 0 ,\nU.S. DOT\nPIDvfSA Office of F[azardous Materials Standards \n C(assiti CQhOv1\nAttention: PIIH·lO\nEast Building II'Oc)1Z1200\nNew Jersey Avenue, SE.\nWashington, DC 20590·0001\nSubject: Formal Letter of Interpretatioll\nDear, Mr. Betts\nIn accordance with 49 CFR 173.115, after review of this section of the CFR it is\nour interpretation that our Focus portable oxygen concentrator manufactured by AirSep\nCorporation in Buffalo New York is exempt as hazardous materials. However we would\nlike your offices concurrence to our interpretation.\nOur complete contact Information is as follows:\nAirSep Corporation\n401 Creekside Drive\nBuffalo, New York 14228\nAtln: Richard W. Boerdner -- Production Manager - POC\n716691-0202 ext. 365\nrboerdner@airsep.com\nThe device for which an exemption is being considered is a portable oxygen\nconcentrator known by the trade name of Focus. People who have a medical condition\nthat requires them to receive supplemental oxygen therapy use this device as a SOlU\"ce of\noxygen. The Focus portable oxygen concentrator separates oxygen from ambient air\nthrough a process called Pressure Swing Adsorption (PSA). This portable oxygen\nconcentrator uses oxygen conserving technology. The systems maximum operating\npressure is 39 psia at 20° C. The device uses multiple power sources, including AC or\nDC power and rechargeable lithium ion battery which is a 2.6 Ah, 38.48 Wh battery\npack. The lithium ion cells and battery pack are compliant to the United Nations Manual\nof Tests and Criteria and is packaged in a manner to prevent short circuits when offered\nfor transport or carried on board passenger aircraft.\n-------------------~~---------------\nMarch 25, 2011\n\n<<<PAGE 4>>>\n\nPage 2\nAirSep Corporation requests your office concurrence that our Focus is exempt\nfrom section 175.10 paragraph A18 which allows a certificate holder to allow passengers\nto carry and operate such devices provided a number of conditions are met. AirSep\nCorporation is not a certificate holder however we do have procedures in place to ensure\nthe safety and effectiveness of the Focus. These include the requirements of the FDA's\nGMP (Good Manufacturing Practices), International standards lEe 60~1-1 General\nrequirements for safety for Medical equipment, and lEC 60~1-1·2 for Electromagnetic\ncompatibility requirements and tests for medical equipment. In addition the AirSep\nQuality Management System is approved as being compliant with the requirements of\n1809000:2000 and ISO 9000: 13485 guideline with no exclusions.\n1 look forward to your review and input on exemption of this product. If you\nshould need any more information please feel free to contact me.\nSincerely,\n'Richard W. Boerdner\nl:U!~~.A(/\nProduction Manager - POC\nAirSep Corporation","truncated":false,"body_characters":6110}