{"operation":"document","citation":"12-0252","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":"2013-01-07","effective_on":null,"summary":"12-0252 response to CHART-SeQual Technologies, Inc. concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0252.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0252.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0252","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120252.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\nJAN 0 7 2013\nMr. Ben Kadrlik\nCHART -SeQual Technologies, Inc.\n2200 Airport industrial Drive, Suite 500\nBall Ground, GA 30107 USA\nRef. No.: 12-0252\nDear Mr. Kadrlik:\nThis responds to your November 2, 2012letter 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 EQUINOX 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 EQUINOX Oxygen System™ is 23.7 pounds per\nsquare inch (psia). The EQUINOX Oxygen System™ is powered by multiple sources,\nincluding AC or DC power, and a rechargeable lithium-ion battery pack. For the\nEQUINOX Oxygen System™ powered by the rechargeable lithium-ion battery pack, the\nlithium-ion cells have a lithium content of 0.45 grams per cell, or 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 of Tests and Criteria,\nand the battery packs are packaged in a manner to prevent short circuits when offered for\ntransport or carried onboard passenger aircraft. You ask whether this device is regulated\nunder the HMR.\nBased on the information provided in your letter, the EQUINOX Oxygen System™ is not\nsubject to the HMR as a Division 2.2 non-flammable gas. The lithium-ion battery pack\nappears to conform to § 172.102( c )(1 ), Special Provision 188 for the transportation of small\nlithium cells and batteries and the POC contains no other hazardous materials. Therefore,\nthe EQUINOX Oxygen System™ is not subject to any other requirements in the HMR.\nPlease note that notwithstanding the passenger exception in § 175.10(a)(18) of the HMR,\nSpecial Federal Aviation Regulation 106 (SFAR 106) \"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 onboard\nan aircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at\n(202) 267-7 480 for questions regarding FAA's approval process.\nI hope this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\n~--P~~--·\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\n~\nCAIRE~\nCH.!JRT-Se(Jlu~:l\nTecltnoloaies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA 30 107\nPhone: 770.721.7700 Fax: 770.721.7701\nwww.chart-ind.com\nNovember 2, 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\nRe: Classification of Chart SeQual Technologies Inc. EQUINOX Oxygen System\nDear Mr. Betts,\nI am writing to request written confirmation from the Pipeline and Hazardous Materials Safety\nAdministration (PHMSA) that Chart SeQual Technologies Inc. new portable oxygen concentrator\n(POC) device known as the \"EQUINOX Oxygen System\" is not subject to the U.S. hazardous\nmaterials regulations (HMR).\nBackground\nThe EQUINOX Oxygen System is a device that separates oxygen from ambient air through a\nprocess called Pressure Swing Adsorption (PSA). The EQUINOX provides a solution to address\nboth stationary and portable requirements for oxygen patients needing up to 3 LPM full flow\noperation and up to 192 ml flow in a pulse mode operation. It consists of a lightweight, portable\noxygen concentrator with an integrated oxygen delivery valve for continuous flow or pulse\ndelivery and is capable of being operated directly from an AC or DC power source or from\nrechargeable lithium ion batteries. It can be recharged and/or powered by a separate AC Power\nAdapter or where standard AC line power is available. A 12-Volt DC cable allows power to be\nprovided by a DC auxiliary power outlet, such as in a motor vehicle during transportation.\nChangeable and rechargeable battery packs are available to provide a range of ambulatory\noperational time.\nThe EQUINOX Oxygen System achieves its performance through SeQual's patented Advanced\nTechnology Fractionator (ATF®) technology and patented variable speed compressor and\ncompressor drive, advanced molecular sieve materials and rechargeable batteries. This system\nwill expand an oxygen patient's ability to travel via aircraft and improve the patient's quality of\nlife.\n\n<<<PAGE 4>>>\n\n~\nC A I R E<, SEQ~:\n' .~ ;;,· -<,-f -' 1 ~ ·~,._ ~,;\nCH.JlRT-SeQlutl\nTecknolooies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA 30 107\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 EQUINOX Oxygen System packaging\ncurrently is 23.7 psia during normal operation at 20° C. This is substantially less than the 43.8\npsia at 20° C referenced in 49 CFR 173 .115(b )(1) for defining a Division 2.2 gas. Therefore, it is\nour opinion that the oxygen exerted within the EQUINOX Oxygen System is not a Division 2.2\ngas and thus is not subject to the U.S. HMR.\nLithium ion Batteries- 49 CFR 173.185\nThe EQUINOX Oxygen System is powered by a lithium ion battery pack designed to be\ncompliant with the UN Manual of Tests and Criteria. The batteries are housed in a single, sturdily\nconstructed plastic enclosure. The entire battery pack consists of 16, 1,500 milli-ampere-hour\nlithium ion cells. Therefore, the pack contains an aggregate equivalent lithium content of 7.20\ngrams.\nBased on the requirements contained in 49 CFR 173.185, it is our opinion that the lithium ion\nbattery pack is not subject to the HMR since the cells contain not more than 5 grams of equivalent\nlithium content, the battery pack contains not more than 25 grams of equivalent lithium content,\nthe battery pack is of the type proven to be non-dangerous by testing in accordance with tests in\nthe UN Manual of Tests and Criteria, and it will be packed in such a way to prevent short circuits\nwhen offered for transport or carried on board passenger aircraft.\nWe also would like to point out that the U.S. HMR contain the following exception in 49 CFR\n175.IO(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\nphones, lap-top computers, camcorders, and hearing aids, etc.) containing lithium cells\nor batteries, and spare lithium batteries and cells for these devices, when carried by\npassengers or crew members in carry-on or checked baggage for personal use. In\naddition, each installed or spare battery must conform to the following: (i) The lithium\ncontent of the anode of each cell, when fully charged, is not more than 5 g; and (ii) The\naggregate lithium content of the anodes of each battery, when fully charged, is not more\nthan 25 g.\"\nThis provision is generally consistent with one found in the ICAO Technical Instructions that\nauthorizes consumer electronic devices containing lithium ion batteries with up to 25 grams of\nequivalent lithium content to be carried onboard passenger aircraft.\n* * * *\n\n<<<PAGE 5>>>\n\nCH.JlRT-SeQuctl\nTeclmolooies Inc.\nSuite 500\n2200 Airport Industrial Drive\nBall Ground, GA30107\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\ndetermination that the EQUINOX Oxygen System is not subject to the U.S. HMR. Should you\nneed additional information or have any questions regarding our product, please do not hesitate to\ncontact me at the information below.\nOur complete contact information is as follows:\nChart SeQual Technologies fuc.\n2200 Airport fudustrial Drive, Suite 500\nBall Ground, GA 30107 USA\nAttn: Ben Kadrlik - Regulatory Specialist\nPhone: 770-721-7700\nFAX: 770-721-7701\nEmail: Ben.Kadrlik@chart-ind.com\nBest Regards,\nBen Kadrlik\nRegulatory Specialist","truncated":false,"body_characters":8438}