{"operation":"document","citation":"12-0199","title":"AirSep Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2012-09-20","effective_on":null,"summary":"12-0199 response to AirSep Corporation concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0199.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0199.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0199","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120199.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue SE\nWashtngton. DC 20590\nSEP 2 0 2012\nRichard W. Boerdner\nProduction Manager- POC\nAirSep Corporation\n401 Creekside Drive\nBuffalo, New York 14228-2085\nRef. No. 12-0199\nDear Mr. Boerdner:\nThis responds to your September 5, 2012letter regarding the applicability of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 1 00-180) to a portable oxygen concentrator your\ncompany manufactures and is known by the trade name FreeStyle 5. You ask whether this device\nis regulated as a hazardous material under the HMR.\nYou state the FreeStyle 5 is a device that separates oxygen from ambient air through a process\ncalled Pressure Swing Absorption (PSA). The maximum operating pressure of the oxygen exerted\nwithin the device is less than 200 kPa (gauge) at 20 °C. The device can be powered by multiple\npower sources, including AC or DC power and a rechargeable 4.8 Ah, 71.04 Wh, lithium ion\nbattery pack. The lithium ion cells and battery pack have been tested pursuant to Sub-section 38.3\nofthe United Nations Manual of Tests and Criteria and are packaged in a manner to prevent short\ncircuits when offered for transportation or are carried onboard passenger-carrying aircraft.\nBased on the information provided, the oxygen in the FreeStyle 5 is not subject to the HMR as a\nDivision 2.2 non-flammable gas. Moreover, it is the opinion of this Office that the FreeStyle 5\ndevice and the lithium ion batteries contained in the device appear to conform to 49 CFR\n172.1 02( c)( 1 ), Special provision 188 (SP 188), for the transportation of small lithium cells and\nbatteries. Thus, provided the conditions in SP 188 continue to be met, the FreeStyle 5 is not subject\nto any other requirements in the HMR.\nAlthough the exception in 49 CFR 175.1 O(a)(18) would apply to a passenger transporting a lithium\nbattery-powered portable oxygen concentrator, the approval of the Federal Aviation Administration\n(FAA) is required before it may be operated onboard an aircraft.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nIndustrial & Medical Air Separation Equipment\nAirSep Corporation\n401 Creekside Drive\nBuffalo, New York 14228-2085\n(716) 691-0202\nFax (716) 691-4141\nSeptember 5, 2012\nMr. Charles Betts\nU.S. DOT\nPHMSA Office of Hazardous Materials Standards\nAttention: PHH-1 0\nEast Building\n1200 New Jersey Avenue, SE.\nWashington, DC 20590-0001\nSubject: Formal Letter of Interpretation\nDear, Mr. Betts\nIn accordance with 49 CFR 173.115, after review of this section of the CFR it is\nour interpretation that our FreeStyle 5 portable oxygen concentrator manufactured by\nAirSep Corporation in Buffalo New York is exempt as hazardous materials. However we\nwould like your offices concurrence to our interpretation.\nOur complete contact Information is as follows:\nAirSep Corporation\n401 Creekside Drive\nBuffalo, New York 14228\nAttn: Richard W. Boerdner- Production Manager - POC\n(716) 691-0202 ext. 365\nrboerdner@airseQ. com\nThe device for which an exemption is being considered is a pmiable oxygen\nconcentrator known by the trade name of FreeStyle 5. People who have a medical\ncondition that requires them to receive supplemental oxygen therapy use this device as a\nsource of oxygen. The FreeStyle 5 portable oxygen concentrator separates oxygen from\nambient air through a process called Pressure Swing Adsorption (PSA). This portable\noxygen concentrator uses oxygen conserving technology. The systems maximum\noperating pressure does not exceed 200 kPa gauge (29.0 psig/43.8 psia) at 20° C (68° F).\nThe device uses multiple power sources, including AC or DC power and rechargeable\nlithium ion battery which is a 4.8 Ah, 71.04 Wh battery pack. The lithium ion cells and\nbattery pack are compliant to the United Nations Manual of Tests and Criteria and is\npackaged in a manner to prevent short circuits when offered for transport or canied on\nboard passenger aircraft.\n\n<<<PAGE 3>>>\n\nPage2\nAirSep Corporation requests your office concurrence that our FreeStyle 5 is\nexempt from section 17 5.10 paragraph A 18 which allows a certificate holder to allow\npassengers to carry and operate such devices provided a number of conditions are met.\nAirSep Corporation is not a certificate holder however we do have procedures in place to\nensure the safety and effectiveness of the FreeStyle 5. These include the requirements of\nthe FDA's GMP (Good Manufacturing Practices), International standards IEC 60601-1\nGeneral requirements for safety for Medical equipment, and IEC 60601-1-2 for\nElectromagnetic compatibility requirements and tests for medical equipment. In addition\nthe AirSep Quality Management System is approved as being compliant with the\nrequirements ofiS09001 :2008 and ISO 9000:13485 guideline with no exclusions.\nI 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,\nRichard W. Boerdner\nProduction Manager - POC\nAirSep Corporation","truncated":false,"body_characters":5205}