{"operation":"document","citation":"04-0053","title":"Inogen Inc — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2004-03-24","effective_on":null,"summary":"04-0053 response to Inogen Inc concerning 173.115.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0053.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0053.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0053","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2004/040053.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n400 Seventh St., S.W.\nResearch and\nWashington, D.C. 20590\nSpecial Programs\nAdministration\nMAR 2 4 2004\nMr. Robert S. Fary\nInogen Inc.\nRef. No. 04-0053\nVice President of Sales\n120 Cremona Drive, Suite B\nGoleta, CA 93117\nDear Mr. Fary:\nThis is in response to your letter dated March 10, 2004, regarding the applicability of the Department\nof Transportation's Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a device that\nyour company calls the Inogen One portable oxygen concentrator.\nThe Inogen One portable oxygen concentrator is a device which separates oxygen from room air for\ndelivery to patients who require supplemental oxygen therapy. It can be powered by multiple power\nsources, including a 12 cell rechargeable lithium ion battery, an AC power pack, and an automobile\ncigarette lighter adapter. The total equivalent lithium content of the battery pack is 7.92 grams and each\ncell of the battery pack has an equivalent lithium content of 0.66 grams. The process by which oxygen\nis separated is called pressure swing adsorption. This process utilizes a small air compressor, valves,\nand controlling electronics to pass air across a material called a molecular sieve. The material acts as a\nfilter to nitrogen and passes the oxygen to the patient. The operating pressure of this device is\napproximately 39 psia. The oxygen concentrator contains no other hazardous material that is subject to\nthe HMR.\nBased on the information above, the Inogen One portable oxygen concentrator is not subject to the\nHMR because: (1) the pressure of the oxygen in the device never exceeds 40.6 psia at 68 °F; (2) the\nlithium ion battery used to operate the device is excepted from the HMR; and (3) the portable oxygen\nconcentrator contains no other material subject to the HMR. Though the lithium ion battery is excepted\nrbidden for transportation unless it is packaged in a manner to preclude it from creating sparks (\nom the hivik it must satisty the requirements of § 173.21(c) which states that an electrical device\ngenerating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals).\nI hope this satisfies your request.\nSincerely,\nElean 7: Marzullo\nEdward T. Mazzullo\nDirector, Office of Hazardous\nMaterials Standards\n173.115\n040053\n\n<<<PAGE 2>>>\n\nGrate\n3173.115\nDenfinitions\nJohn A. Gale\nTransportation Regulations Specialist\n04-0053\nU.S Department of Transportation\n400 Seventh Street S.W.\nWashington, DC 20590-0001\nMarch 10, 2004.\nDear John,\nexcited about the changes that are coming that will result in increased access and\nOnce again, many thanks for allowing us to visit and present the Inogen One. I am\nconvenience for oxygen users who travel.\nstandard. I am happy to say that we are within the guidelines stated in the regulation.\nI have attached the information you requested relative to the battery and the current\nI respectfully request a letter from you that states that you have found the Inogen One to\nbe safe and non-hazardous for use on commercial aircraft. Please e-mail the letter to me\nat isfary@inogen.net.\nPlease do not hesitate to call me with any questions or issues that may arise.\nBest Regards,\nRobert S. Fary\nVice President of Sales\nInogen Corporation\n120 Cremona Drive, Suite B\nGoleta, CA 93117\n805-562-0512\nrsfary@inogen.net\n\n<<<PAGE 3>>>\n\n1. In response to questions regarding 49 CFR 173.115 (Definition of a Flammable Gas):\nThe regulations suggest that oxygen produced by the Inogen One oxygen\nconcentrator should not be recognized as a \"flammable gas\" as the maximum\npressure exerted within the product packaging is 39psia or less (depending o1\nperating mode) at 20oC (and 1 bar ambient pressure), and is therefore less thar\nthe 40.6psia specified in 49CFR 173-115 paragraph (b) (1).\n2. In response to questions regarding 49 CFR 173.185 (Lithium Batteries and Cells):\nThe Inogen One battery pack contains 12 cells of the 2.2Ah 18650 cell type.\nLithium Content of 7.92g.\nEach cell has an Equivalent Lithium Content of 0.66g*, for a total Equivalent\nBecause (a) there is less than 1.5g of lithium per cell, (b) less than 8.0g total\nlithium, and (c) less than or equal to 12 cells per battery pack, an individual pack\nprevent short circuits.\nis not a Class 9 material. Each pack is strongly packaged and packed in a way to\nNonetheless, Inogen intends to and certifies that it will (1) label all of its batteries\nas containing lithium; (2) label any packaging for the battery to indicate that they\ncontain lithium batteries, (3) qualify the battery through UN tests (T1-T8).\n\"Equivalent Lithium Content is measured as 0.3 times the rated capacity (ampere hours (Ah)) of\nthe battery equals the sum of the grams of lithium equivalent content contained in the component\nthe cell in Ampere-hours, with the results expressed in grams. The lithium-equivalent content of\ncells of the battery. (Example: an 18650 Li-ion cell with 1.8Ah of rated capacity would contain\nof Lithium Transportation Regulations - as of May 2003), Panasonic Industrial Company.\"\n0.54g of lithium (1.8 x 0.3) and 6 of these cells in a pack would equal 3.24g). Source: \"Overview\n3. Additionally, 14 CFR 125.219 and 135.91 were mentioned. As both of these apply to\nrules governing use of devices on aircraft, and not the devices themselves, we feel they\nare not germane to this discussion.","truncated":false,"body_characters":5374}