{"operation":"document","citation":"13-0177","title":"CHART-SeQual Technologies, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-09-18","effective_on":null,"summary":"13-0177 response to CHART-SeQual Technologies, Inc. concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0177.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0177.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0177","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2013/130177.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nSEP 1 8 2013\nMr. Neal Maloy\nDirector- Quality and Regulatory Affairs\nCHART-SeQual Technologies, Inc.\n2200 Airport Industrial Drive, Suite 500\nBall Ground, GA 30107 USA\nRef No.: 13-0177\nDear Mr. Maloy:\nThis responds to your August 26, 2013 letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to a portable oxygen\nconcentrator (POC). Specifically, you inquire about obtaining Federal Aviation\nAdministration (FAA) approval to allow a passenger to carry the POC aboard an aircraft.\nAccording to your letter, the POC (trade name OXYWELL Oxygen System™) is a device\nthat is for use by patients requiring high concentrations of oxygen on a supplemental basis.\nThe maximum operating pressure of the OXYWELL Oxygen System™ is 23.7 pounds per\nsquare inch (psia). The OXYWELL Oxygen System™ is powered by multiple sources,\nincluding AC or DC power, and a rechargeable lithium-ion battery pack. For the OXYWELL\nOxygen System™ powered by the rechargeable lithium-ion battery pack, the lithium-ion cells\nhave an equivalent lithium content of 0.45 grams per cell and 7.20 grams of aggregate\nequivalent lithium content for the battery pack. The lithium-ion battery packs are types\ndesigned to meet the appropriate tests in the United Nations Manual ofTests and Criteria, and\nthe battery packs are packaged in a mmmer to prevent short circuits when offered for transport\nor carried onboard passenger aircraft. You ask whether this device is regulated under the\nHMR.\nBased on the information provided in your letter, the OXYWELL Oxygen System™ is not\nsubject to the HMR as a Division 2.2 non-flammable gas. The lithium-ion battery pack used\nto operate the device appears to conform to § 172.1 02( c )(1 ), Special Provision 188, for the\ntranspmiation of small lithium cells and batteries and the POC contains no other hazardous\nmaterials. Therefore, the OXYWELL Oxygen System™ is not subject to any other\nrequirements in the HMR.\nPlease note that notwithstanding the passenger exception in§ 175.10(a)(l8) ofthe HMR,\nSpecial Federal Aviation Regulation 106 (SF AR 1 06) \"Rules for Use of Portable Oxygen\nConcentrator Systems on Board Aircraft\" apply and are under the purview of the FAA, not\nthe Pipeline and Hazardous Materials Safety Administration. This response letter satisfies\n\n<<<PAGE 2>>>\n\nonly one requirement in the FAA approval process before a POC may be operated on board an\naircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at\n(202) 267-7480 for questions regarding FAA's approval process.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nb n g~i:l:einvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\n~\nCAIRE®\nCH.!lRT-SeQual\nTecltnolooies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA 30107\nPhone: 770.721.7700 Fax: 770.721.7701\nwww.chart-ind.com\nAugust 26, 2013\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\nRe: Letter dated January 7, 2013; Ref. No. 12-0252\nDear Mr. Betts,\nPer the referenced letter, the EQUINOX Oxygen System was granted an exemption from the U.S.\nhazardous materials regulations (HMR) in January 2013. The OXYWELL Oxygen System is based on\nthe same concept as the EQUINOX Oxygen System and is a privately branded EQUNIOX Oxygen\nSystem per the request of a customer in Japan. I am writing to request the petition for exemption from the\nU.S. hazardous materials regulations (HMR) to also include the OXYWELL Oxygen System.\nI am requesting written confirmation from the Pipeline and Hazardous Materials Safety Administration\n(PHMSA) that Chart SeQual Technologies Inc. new portable oxygen concentrator (POC) device known\nas the \"OXYWELL Oxygen System\" is not subject to the U.S. hazardous materials regulations (HMR).\nBackground\nThe OXYWELL Oxygen System is a device that separates oxygen from ambient air through a process\ncalled Pressure Swing Adsorption (PSA). The OXYWELL provides a solution to address both stationary\nand portable requirements for oxygen patients needing up to 3 LPM full flow operation and up to 192 ml\nflow in a pulse mode operation. It consists of a lightweight, portable oxygen concentrator with an\nintegrated oxygen delivery valve for continuous flow or pulse delivery and is capable of being operated\ndirectly from an AC or DC power source or from rechargeable lithium ion batteries. It can be recharged\nand/or powered by a separate AC Power Adapter or where standard AC line power is available. A 12-Volt\nDC cable allows power to be provided by a DC auxiliary power outlet, such as in a motor vehicle during\ntransportation. Changeable and rechargeable battery packs are available to provide a range of ambulatory\noperational time.\nThe OXYWELL Oxygen System achieves its performance through SeQual's patented Advanced\nTechnology Fractionator (ATF®) technology and patented variable speed compressor and compressor\ndrive, advanced molecular sieve materials and rechargeable batteries. This system will expand an oxygen\npatient's ability to travel via aircraft and improve the patient's quality oflife.\n\n<<<PAGE 4>>>\n\n~\nCAIRE~\nCH.IlRT-SeQu£tl\nTecltnolooies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA 30107\nPhone: 770.721.7700 Fax: 770.721.7701\nwww.chart-ind.com\nClass 2, Division 2.2 Gas- 49 CFR 173.115\nThe maximum pressure of the oxygen exerted within the OXYWELL Oxygen System packaging\ncurrently is 23.7 psia during normal operation at 20° C. This is substantially less than the 43.8 psi a at 20°\nC referenced in 49 CFR 173 .115(b )(1) for defining a Division 2.2 gas. Therefore, it is our opinion that the\noxygen exerted within the OXYWELL Oxygen System is not a Division 2.2 gas and thus is not subject to\nthe U.S. HMR.\nLithium ion Batteries - 49 CFR 173.185\nThe OXYWELL Oxygen System is powered by a lithium ion battery pack designed to be compliant with\nthe UN Manual of Tests and Criteria. The batteries are housed in a single, sturdily constructed plastic\nenclosure. The entire battery pack consists of 16, 1,500 milli-ampere-hour lithium ion cells. Therefore,\nthe pack contains an aggregate equivalent lithium content of7.20 grams.\nBased on the requirements contained in 49 CFR 173.185, it is our opinion that the lithium ion battery\npack is not subject to the HMR since the cells contain not more than 5 grams of equivalent lithium\ncontent, the battery pack contains not more than 25 grams of equivalent lithium content, the battery pack\nis of the type proven to be non-dangerous by testing in accordance with tests in the UN Manual of Tests\nand Criteria, and it will be packed in such a way to prevent short circuits when offered for transport or\ncarried onboard passenger aircraft.\nWe also would like to point out that the U.S. HMR contain the following exception in 49 CFR\n175.10(a)(27) (as amended by PHMSA's Interim Final Rule HM-224E) for passengers and crew\nmembers:\n\" ... consumer electronic and medical devices (watches, calculators, cameras, cellular phones,\nlap-top computers, camcorders, and hearing aids, etc.) containing lithium cells or batteries, and\nspare lithium batteries and cells for these devices, when carried by passengers or crew members\nin carry-on or checked baggage for personal use. In addition, each installed or spare battery\nmust conform to the following: (i) The lithium content of the anode of each cell, when fully\ncharged, is not more than 5 g; and (ii) The aggregate lithium content of the anodes of each\nbattery, when fully charged, is not more than 25 g.\"\nThis provision is generally consistent with one found in the ICAO Technical Instructions that authorizes\nconsumer electronic devices containing lithium ion batteries with up to 25 grams of equivalent lithium\ncontent to be carried onboard passenger aircraft.\n* * * *\n\n<<<PAGE 5>>>\n\n~\nCAIRE.~ CH.!IRT-Sefl~tctl\nTecltnolooies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA 30107\nPhone: 770.721.7700 Fax: 770.721.7701\nwww.chart-ind.com\nI trust the information contained herein is sufficient for PHMSA to provide a written determination that\nthe OXYWELL Oxygen System is not subject to the U.S. HMR. Should you need additional information\nor have any questions regarding our product, please do not hesitate to contact me at the information\nbelow.\nOur complete contact information is as follows:\nChart SeQual Technologies Inc.\n2200 Airport Industrial Drive, Suite 500\nBall Ground, GA 30107 USA\nAttn: Neal Maloy, Director- Quality and Regulatory Affairs\nPhone: 770-721-7700\nFAX: 770-721-7701\nEmail: Neal.Maloy@chart-ind.com\nBest Regards,\n;J!J/f!~\n(/~\n'\n'\nNeal Maloy\nDirector - Quality and Regulatory Affairs","truncated":false,"body_characters":8915}