{"operation":"document","citation":"08-0229","title":"DeVibiss Healthcare — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-11-26","effective_on":null,"summary":"08-0229 response to DeVibiss Healthcare concerning 173.21.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0229.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0229.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0229","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080229.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave., SE\nWashington, DC 20590\nMr. David Greene\nDeVibiss Healthcare\n100 DeVilbiss Drive\nSomerset, PA 15501 -2125\nRef. No. 08-0229\nDear Mr. Greene:\nThis responds to your letter dated August 25,2008 regarding the applicability of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171 -1 80) to a device your company\ncalls the iGo Portable Oxygen Concentrator (POC).\nAccording to your letter the iGo Portable Oxygen Concentrator is a device that produces an\noxygen enriched gas mixture by drawing in room air and extracting nitrogen. The device is\nlight and capable of operating from an installed lithium ion battery pack. The device has a\nmaximum operating pressure of 14 psia and is equipped with a pressure relief device\ndesigned to operate at 20 psia * 3 psia. The lithium ion battery pack contains less than 8\ngrams equivalent lithium content and is a type proven to meet the requirements of each test in\nthe UN Manual of Tests and Criteria. Though the lithium ion battery is excepted from the\nHMR, it must satisfy the requirements of 8 173.21(c) which states that an electrical device is\nforbidden for transportation unless it is packaged in a manner to preclude it from creating\nsparks or generating a dangerous quantity of heat (for example, by the effective insulation of\nexposed terminals).\nBased on the information provided, the iGo portable oxygen concentrator is not currently\nsubject to the HMR because it meets the following criteria:\n(I) The pressure of the oxygen in the device does not exceed 40.6 psia at 20°C;\n(2) The lithium ion battery used to operate the device is excepted from the HMR;\n(3) The portable oxygen concentrator contains no other materials subject to the HMR; and\n(4) The battery pack is packaged in a manner to preclude it fiom creating sparks or\ngenerating a dangerous quantity of heat (for example, by the effective insulation of exposed\nterminals).\nYou should also note Federal Aviation Administration (FAA) approval is required before\nthese electronic devices are used by passengers on board aircraft. The FAA published a final\nrule in the Federal Register regarding these devices on July 12,2005 (70 FR 40156).\n\n<<>>\n\nIn addition, even with FAA approval the air carrier ultimately determines what may or may\nnot be carried on its aircraft. We suggest that you check with the air carrier to ensure that the\niGo portable oxygen concentrator may be carried.\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\nSincerely,\ni ' ,' dhc d2\nCharles E. Betts\nChief, Standards Development\nOffice of Hazardous Materials Standards\n\n<<>>\n\nRequest for Determination - Personal Oxygen Concentrator Lea r y Page 1 of 2\nDrakeford, Carolyn \nFrom: INFOCNTR \nSent: Thursday, September 18,2008 4 44 PM\nTo: Drakeford, Carolyn \nSubject: FW: Request for Determination - Personal Oxygen Concentrator\nFrom: Greene, Dave [mailto:Dave.Greene@DeVilbissHC.com]\nSent: Monday, August 25,2008 11:06 AM\nTo: INFOCNTR \nSubject: Request for Determination - Personal Oxygen Concentrator\nAttn: Mr. Edward Mazzullo\nDirector, Office of Hazardous Materials Standards\nU.S. DOTIPHMSA (PHH-10)\n1200 New Jersey Avenue, SE East Building, 2nd Floor43\nWashington, DC 20590\nDear Mr. Mazzullo;\nAn HMlC Customer Service Representative has referred me to you in the matter described below.\nDeVilbiss Healthcare is preparing to enter the market with a new Portable Oxygen Concentrator (POC) and is\nrequesting amendment to SFAR 106 to include the iGo Portable Oxygen Concentrator in the list of approved\nPOC's for aircraft use. Section 2 of SFAR 106 requires that PHMSA determine that the POC does not contain\nhazardous materials and that the requestor must provide documentation to the FDA to that effect. This e-mail is a\nrequest for such a determination and response relating that determination.\nBackqrou nd\nDeVilbiss Healthcare is a manufacturer of therapeutic respiratory devices for use in the home and clinical settings.\nWe have been a producer of oxygen concentrators for victims of Chronic Obstructive Pulmonary Disease (COPD)\nand other lung disorders since 1974. We have completed the development of a POC and are preparing for market\nentry.\nThe iGo Portable Oxygen Concentrator is a device that produces an oxygen enriched gas mixture (93%\nconcentration of oxygen) by drawing in room air and extracting nitrogen, thus allowing oxygen to be delivered at a\nrange of prescribed flows to patients with low oxygen saturation levels in the blood. The iGo Portable Oxygen\nConcentrator is light weight and can operate from an attached lithium-ion battery pack, features which allow the\niGo Portable Oxygen Concentrator to be readily transported by the patient. It has two operating modes:\ncontinuous product flow at up to 3 LPM and pulse dosage mode at settings of 1 to 6. In pulse dosage mode, the\nconcentrator delivers a bolus of oxygen at each inhalation in an amount equal to 14cc times the setting value. The\niGo Portable Oxygen Concentrator is sized to fit easily under the seat of a commercial aircraft, permitting the user\nto travel by air with prescribed therapy.\nSpecifically, the following characteristics relate to the concentrator and its battery pack:\n1. The operating pressure of the device is 14 psia (maximum), and a safety relief valve with a lift\npressure of 20 (+I-3) psia is provided in the gas circuit.\n2. The lithium ion battery pack contains less than 8 grams of lithium. The pack has passed IATA\ntesting. The conclusion of the test sequence was that \"The pack passes all the IATA\n\n<<>>\n\nRequest for Determination - Personal Oxygen Concentrator Page 2 of 2\n3. 4. 5. requirements as per the UN document ST/SG/AC.10/27/Add.2.\" The battery pack does not\nfall under Class 9 as per DOT 49 CFR Ch. I specifications (aggregate equivalent lithium\ncontent is less than 8 gms, approximately 7.92 grams).\nThe battery pack has no exposed terminals which could be the source of a short circuit. The\nsafety features of the battery pack include a safety circuit to prevent over current generation,\ntwo electronic and one physical fuse and thermistors to detect excessive temperatures in the\nbattery assembly and shut down operation of the battery.\nThe iGo Portable Oxygen Concentrator contains no other materials subject to the HMR, and\nThe battery pack is packaged in a manner to preclude it from creating sparks or generating a\ndangerous amount of heat or being subject to short-circuiting at exposed terminals.\nIf additional information is required from DeVilbiss Healthcare for the requested determination, please contact me\nat 724-41 3-4007 or e-mail me at Dave.Greene@DeVilbissHC.com.\nThank you for your assistance,\nDavid Greene, PhD\nConsultant to DeVilbiss Healthcare","truncated":false,"body_characters":6885}