{"operation":"document","citation":"08-0266","title":"International Biophysics Corporation (IBC) — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-01-08","effective_on":null,"summary":"08-0266 response to International Biophysics Corporation (IBC) concerning 173.115, 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0266.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0266.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0266","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080266.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration 1200 New Jersey Ave.. SE\nWashington, DC 20590\nJAN 0 8 2009\nMr. William R. Wilkinson\nVice President of Engineering\nInternational Biophysics Corporation (IBC)\n2100 East St. Elmo Rd.\nAustin, TX 78744\nRef. No. 08-0266\nDear Mr. Wilkinson:\nThis is in response to your October 13, 2008 letter regarding the applicability of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 100-180) to a device your company calls the\nLifeChoice Portable Oxygen Concentrator (POC).\nYou state in your letter and a subsequent conversation with a member of my staff that the\nLifeChoice POC is a lightweight device that separates nitrogen from room air through the pressure\nswing absorption (PSA) process and stores the resultant concentrated oxygen gas for delivery to\npatients requiring supplemental oxygen. This device delivers the oxygen to the patient through the\npulse dose delivery method. The maximum internally attainable pressure during the PSA cycle of\nthe device is 22 psig (36.7 psia) over an operating temperature range of 5 \"C to 40 OC (41 O F to 104\nOF), with a maximum oxygen accumulator quantity of 45 mil per minute for operation in the pulse\nmode. The device can be powered by multiple power sources, including an internally captive,\nrechargeable lithium ion battery pack, AC to DC power adaptor, by an external DC to DC power\nadapter, or an external accessory lithium ion battery pack. The internally captive lithium ion battery\nconsists of 8 rechargeable 2.2 amp-hour lithium ion cells with 0.3 grams of lithium content each, or\na total of 5.2 grams of total equivalent lithium content (0.3 x 2.2 Ah x 8 cells), and no other\nhazardous materials. The external accessory battery module consists of two battery packs, each\ncontaining a total of 5.2 grams of total equivalent lithium content, or a total of 10.4 grams of total\nequivalent lithium content. The lithium ion battery pack has been tested pursuant to the United\nNations Manual of Tests and Criteria and is packaged in a manner to prevent short circuits when\noffered for transport or carried onboard passenger aircraft. You ask whether this device is regulated\nas a hazardous material under the HMR.\nBased on the information provided, the LifeChoice POC is not currently subject to the HMR\nbecause it meets the following criteria:\n1. The pressure of the oxygen in the device does not exceed 280 kPa (40.6 psia) at 20 \"C\n(68 OF);\n2. The lithium ion batteries used to operate the device are excepted in the HMR;\n\n<<<PAGE 2>>>\n\n3. The portable oxygen concentrator contains no other materials subject to the HMR; and\n4. The battery pack is packaged in a manner to preclude it from creating sparks or generating a\ndangerous quantity of heat (for example, by the effective insulation of exposed terminals).\nYou should also note Federal Aviation Administration (FAA) approval is required before these\nelectronic devices are used by passengers on board aircraft. The FAA published a final rule in the\nFederal Register regarding these devices on July 12,2005 (70 FR 40156). For further assistance,\nyou may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations\nBranch (AFS-220) by phone at (202)-267-3732 or email at david.c;r~cy(ci.sfiia.f~ov.\nIn addition, even with FAA approval the air carrier ultimately determines what may or may not be\ncarried on its aircraft. We suggest that you check with the air carrier to ensure that the Lifechoice\nportable oxygen concentrator may be carried.\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nI n t e r n a t i o n a l B i o p h y s i c s C o r p o r a t i o n\nOctober 13,2008 FS s+er\n3 173 1 6 (18\nMr. ~ d w a r d Mazzullo Director\nPipeline and Hazardous Materials Safety Administration Office of Hazardous Materials Standards\n1200 New Jersey Avenue, SE East Building, 2nd Floor\nWashington, DC 20590\nat& n i h\n68.0 2b6\nRe: International Biophysics Corporation, LifeCho,ice Portable Oxygen Concentrator\nDear Mr. Mazzullo,\nInternational Biophysics Corporation (IBC) is requesting written confirmation from\nthe Pipeline and Hazardous Materials Safety Administration that the LifeCho,ice\nPortable Oxygen Concentrator (POC) is not subject to the U.S. hazardous materials\n512.326.3244 regulation under HMR; 49 CFR Parts 100- 180 after review of all appropriate\nF 51 2.326.3299 information.\nwww.lBCbio.com\n2101 East St, Rd Suite 275 TX 78744 LifeCho,ice POC is a light weight device that separates nitrogen from room air\nthrough the pressure swing absorption (PSA) process and stores the resultant\nconcentrated oxygen gas for delivery to patients who need supplemental oxygen\ntherapy. LifeCho,ice delivers the oxygen to the patient through the pulse dose\ndelivery method for maximum effectiveness and power efficiency. This means that a\npulse of oxygen of the correct quantity is delivered through the nasal cannula only\nwhen an inhalation is detected. With this method, accumulations of excess oxygen in\nthe surrounding environment are minimized.\nThe maximum internally attainable pressure during the PSA cycle of the LifeCho,ice\nPOC is 22 PSIG (36.7 PSIA) over an operating temperature range of 5 degrees\nCelsius and 40 degrees Celsius. As this maximum operating pressure is below 40.6\nPSIA at 20 degrees Celsius for a division 2.2 gas in CFR 173.1 15(b)(l), IBC believes\nthe LifeCho,ice POC is not subject to the U.S. HMR regulation for oxygen gas.\nThe LifeCho,ice POC can be powered by an internally captive, rechargeable lithium\nion battery pack that is not removable or replaceable by the user of the device, by an\nexternal AC to DC power adapter, by an external DC to DC power adapter, or an\nexternal accessory lithium ion battery pack. This allows for maximum flexibility and\noperational time with multiple power sources. Recharging is only available with the\nuse of the AC-DC or DC-DC power adapters.\nS i ~ c e 1992, International\nBiophysics corporation bas\nmanufactured\nniedica l devices\nand surgical\ncomponents\nIBC is proudly\ncertified as IS0 9001\nand I S 0 1 3 4 8 5\n\n<<<PAGE 4>>>\n\nThe internally captive lithium ion battery consists of 8 rechargeable 2.2 amp-hour\nlithium ion cells. Therefore, the total equivalent lithium content is 0.3 x 2.2 Ah x 8 ,\ncells = 5.2 grams of equivalent lithium content for this internal battery.\nThe internally captive lithium battery is not user accessible and not replaceable by a\npatientluser. It is securely captured in the product. The internally captive mechanism\nof the LifeCho,ice POC also prevents any user from generating sparks or short-\ncircuiting as it is not externally accessible. The battery pack terminals are not exposed\nto any outside contact by virtue of being totally integrated into the product.\nThe external accessory battery module for extended operating time is a self contained\nseparate battery accessory for the LifeCho,ice POC. The external battery module\ncontains two battery packs. Each battery pack contains 8 rechargeable lithium ion\ncells of 2.2 amp-hour per cell. Therefore, the total equivalent lithium content per\nbattery pack is 0.3 x 2.2 Ah x 8 cells = 5.2 grams of equivalent lithium content per\nbattery pack. Therefore, the external battery module contains a total of 10.4 grams\nwhich is less than 25 grams of equivalent lithium content in its two battery packs.\nThe external accessory battery module is not user accessible and the cells contained\nwithin the module are not replaceable by the patientluser. This captive mounting\nmechanism of the external battery module also prevents any user from generating\nsparks or short-circuiting of the lithium ion battery pack. The battery pack terminals\nare not exposed to any outside contact as they are connected to an intervening power\nswitching and charging circuit board that interfaces to the LifeCho,ice POC. The\nexternal battery module connection cable contains a connector that prevents\naccidental shorting or generation of sparks during handling and storage.\nLBC believes that based on the requirements of 49 CFR 173.1850)2), both the\ninternally captive lithium ion batteries and the lithium ion external battery module are\nexempt from the HMR requirements. The individual cells do not contain more than\n1.5 grams of lithium equivalent content and each battery does not contain more than 8\ngrams of lithium equivalent content. The external battery module contains less than\n25 grams of lithium equivalent content in aggregate in its two batteries. In addition,\nboth the internally captive and external accessory battery module are packed securely\nwithin their respective product cases and are protected from short-circuiting and spark\ngeneration.\nLBC believes that all the other materials used in the device are not subject to the U.S.\nhazardous materials regulation under HMR 49 CFR Parts 100- 180.\nTo Summarize:\n1. The pressure of the oxygen in the LifeCho,ice POC does not exceed 40.6 PSIA at\n20 degrees Celsius;\n2. 3. The cells contain not more than 1.5 grams of lithium equivalent content;\nThe lithium ion battery packs contain an aggregate equivalent lithium content of\nnot more than 8 grams;\n\n<<<PAGE 5>>>\n\n4. ,The device contains no other materials subject to the HMR; and\n5. The batteries are fully contained in the equipment and packaged in a manner to\npreclude sparks or the generation of a dangerous quantity of heat.\nBased on all of the above, IBC believes that the LifeCho,ice POC and the accessory\nexternal battery module meet special provision 188.\nIn addition, IBC understands that the FAA approval is required before the\nLifeCho,ice POC may be used by passengers on board aircraft. We have already\nsubmitted an application to Mr. David Catey of the FAA and he has informed us that\nthe remaining requirement is the letter fiom your office that states that LifeCho,ice\nPOC meets Special Provision 188, and not otherwise subject to the HMR.\nThank you for your time and attention on this matter. If any further information is\nrequired, please contact me at (512) 326-3244 Extension 110. '\nSincerely,\nInternational Biophysics Corporation\nb\nWilliam R. Wilkinson\nVice President of Engineering\n(5 12) 326-3244 Ext. 110 Office\n(512) 326-3299 Fax\n(5 12) 466-7214 Cell\nbill@,ibcbio.com\nCC: Len Hickey\nOperations and Regulatory Affairs Manager","truncated":false,"body_characters":10461}