{"operation":"document","citation":"05-0215","title":"SeQual Technologies, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2005-11-30","effective_on":null,"summary":"05-0215 response to SeQual Technologies, Inc. concerning 173.115, 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0215.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0215.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-05-0215","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2005/050215.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nJ.S. Departmen\nNOV 30 2005\nWashington, D.C. 20590\n400 Seventh Street, S.W.\nPipeline and\nAdministration\nHazardous Materials Safety\nMs. Pamela J. Jackson\nReference No.: 05-0215\nDirector of Marketing\nSeQual Technologies, Inc.\n11436 Sorrento Valley Road\nSan Diego, CA 92121\nDear Ms. Jackson:\nThis is in response to your August 30, 2005 letter regarding the applicability of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a device that your\ncompany calls the Eclipse Oxygen System.\nYou state in your letter that the Eclipse Oxygen System is a device that separates oxygen\nfrom ambient air for delivery to patients who require supplemental oxygen therapy. This\ndevice consists of a lightweight, portable oxygen concentrator with an integrated oxygen\ndelivery valve for continuous flow or pulse delivery. The process by which oxygen is\nseparated is called Pressure Swing Absorption (PSA). The maximum pressure of the\noxygen exerted within the Eclipse Oxygen System packaging is 23.7 psia during normal\noperation at 20 °C. The device can be powered by multiple power sources, including AC\nor DC power, an AC adapter, rechargeable lithium ion batteries, and an automobile\ncigarette lighter adapter. The battery pack consists of 24, 2.2 ampere-hour lithium ion\ncells, and the total equivalent lithium content of the battery pack is 15.8 grams. The\nlithium ion battery pack has been tested pursuant to the United Nations Manual of Tests\nand Criteria and is packaged in a manner to prevent short circuits when offered for\ntransport 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 Eclipse Oxygen System portable oxygen\nconcentrator is not currently subject to the HMR because: (1) the pressure of the oxygen\nin the device does not exceed 40.6 psia at 20 °C; (2) the lithium ion battery used to\noperate the device is excepted from the HMR (§ 173.185(c)(2))); (3) the portable oxygen\npackaged in a manner to preclude it from creating sparks or generating a dangerous\nconcentrator contains no other materials subject to the HMR; and (4) the battery pack is\nquantity of heat (for example, by the effective insulation of exposed terminals).\nIn accordance with the 2005-2006 Edition of the International Civil Aviation\nOrganization Technical Instructions for the Safe Transport of Dangerous Goods by Air,\nyour device is regulated as a Class 9 material when transported as cargo onboard\npassenger and cargo aircraft. However, the device may be authorized for transportation\nonboard passenger aircraft as consumer electronic devices containing lithium ion\n173.115\n173.185\n050215\n175.10\n\n<<<PAGE 2>>>\n\nbatteries with up to 25 grams of equivalent lithium content when carried by passengers or\ncrew for personal use and protected so as to prevent short circuits.\nIn addition, Federal Aviation Administration (FAA) approval is required before these\nelectronic 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).\nYou may be interested to know that, in a notice of proposed rulemaking published under\nDocket HM-224E on December 15, 2004 (69 FR 75207), the Pipeline and Hazardous\nMaterials Safety Administration has proposed to eliminate the 25-gram exception for\nlithium batteries found under § 173.185(c)(2) of the HMR. Please refer to our website at\nhazmat.dot.gov under the Rules and Regulations icon, in the rulemaking and Federal\nRegister Notices section.\nI trust this satisfies your inquiry.\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nFoster\n$ 173.115\n•SEQUAL\n§ 173.185\nSeQual Technologies Inc.\n11436 Sorrento Valley Rd. • San Diego, CA 92121-1306 • 858/202-3100 • FAX 858/558-1915\n$175.10\nApplicability\nAugust 30, 2005\n05-0215\nMr. John Gale\nChief, Standards Development\nOffice of Hazardous Materials Standards\nPipeline and Hazardous Materials Safety Administration\nU.S. Department of Transportation\n400 Seventh Street SW\nWashington, DC 20590-0001\nRe: Classification of SeQual Technologies' Eclipse™ Oxygen System\nDear Mr. Gale:\nThank you very much for taking the time on the phone and allowing me to speak\nwith you regarding SeQual Technologies' portable oxygen concentrator (POC) device\nfrom the Pipeline and Hazardous Materials Safety Administration (PHMSA) that the\nknown as the Eclipse™ Oxygen System. I am writing to request written confirmation\nEclipse™ Oxygen System is not subject to the U.S. hazardous materials regulations\n(HMR).\nBackground\nThe SeQual Eclipse Oxygen System is a device that separates oxygen from\nconcentrated oxygen is used for delivery to patients with Chronic Obstructive\nambient air through a process called Pressure Swing Adsorption (PSA). The\nPulmonary Disease (COPD) that require supplemental oxygen therapy. The Eclipse\nprovides a solution to address both stationary and portable requirements for oxygen\npatients having prescriptions of up to 3 LPM full flow operation and up to 6 LPM flow\nin a pulse flow mode operation. It consists of a lightweight, portable oxygen\nconcentrator 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\nfrom rechargeable lithium ion batteries. It can be recharged and/or powered by a\nseparate AC adapter for use by the patient or where standard AC line power is available.\nThe DC power adapter accessory allows power to be provided by a DC auxiliary power\noutlet, such as in a motor vehicle during transportation. User changeable battery packs\nare available to provide a range of ambulatory operational time.\nThe Eclipse Oxygen System achieves its performance through SeQual's\npatented Advanced Technology Fractionator (ATF®) technology and patented variable\nPage 1 of 3\n\n<<<PAGE 4>>>\n\nspeed compressor and compressor drive, advanced molecular sieve materials and\nrechargeable batteries. This system will expand an oxygen patient's ability to travel via\naircraft and improve the patient's quality of life.\nClass 2, Division 2.2 Gas - 49 CFR 173.115\nThe maximum pressure of the oxygen exerted within the Eclipse Oxygen\nSystem packaging currently is 23.7 psia during normal operation at 20° C. This is\nsubstantially less than the 40.6 psia at 20° C referenced in 49 CFR 173.115(b)(1) for\ndefining a Division 2.2 gas. Therefore, it is our opinion that the oxygen exerted within\nthe Eclipse Oxygen System is not a Division 2.2 gas and thus is not subject to the U.S.\nHMR.\ncellcontenti\nLithium ion Batteries - 49 CFR 173.185\nThe Eclipse Oxygen System is powered by a lithium ion battery pack that has\nbeen tested pursuant to the UN Manual of Tests and Criteria. The. pack is a unique\ndesign in that it contains two independent batteries. Each battery is electrically isolated\nand mechanically separated to prevent short circuits. The batteries are housed in a\nsingle, sturdily constructed plastic enclosure. The entire battery pack consists of 24, 2.2\nhow\nampere-hour lithium ion cells. Therefore, the pack contains an aggregate equivalent\nlithium content of 15.8 grams.\nBased on the requirements contained in 49 CFR 173.185(c), it is our opinion\nthat the lithium ion battery pack is not subject to the HMR since the cells contain not\nmore than 5 grams of equivalent lithium content, the battery pack contains not more\nthan 25 grams of equivalent lithium content, the battery pack is of the type proven to be\nnon-dangerous by testing in accordance with tests in the UN Manual of Tests and\nCriteria, and it will be packed in such a way to prevent short circuits when offered for\ntransport or carried onboard passenger aircraft.\nWe also would like to point out that the U.S. HMR contain the following\nexception in 49 CFR 175.10(a)(27) (as amended by PHMSA's Interim Final Rule HM-\n224E) for passengers and crew members:\n... consumer electronic and medical devices (watches, calculators, cameras,\ncellular phones, lap-top computers, camcorders, and hearing aids, etc.)\ncontaining lithium cells or batteries, and spare lithium batteries and cells for\nthese devices, when carried by passengers or crew members in carry-on or\nchecked 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,\nwhen fully charged, is not more than 5 g; and (ii) The aggregate lithium content\nof the anodes of each battery, when fully charged, is not more than 25 g:\"\nThis provision is generally consistent with one found in the ICAO Technical\nInstructions that authorizes consumer electronic devices containing lithium ion batteries\nwith up to 25 grams of equivalent lithium content to be carried onboard passenger\naircraft.\n*% *\n*\n*\nPage 2 of 3\n\n<<<PAGE 5>>>\n\nI trust the information contained herein is sufficient for PHMSA to provide a\nwritten determination that the Eclipse™ Oxygen System is not subject to the U.S.\nHMR. Should you need additional information or have any questions regarding our\nproduct, please do not hesitate to call me at the contact information below.\nRespectfully,\nPamela person\nPamela J. Jackson\nDirector of Marketing\nSeQual Technologies Inc.\n11436 Sorrento Valley Road\nSan Diego, CA 92121\nPhone: 858-202-3144\nFAX: 858-558-1915\nCell: 760-805-9000\nEmail: pjackson@sequal.com\ncc: Robert Schneider, Vice President Business Development, SeQual Technologies Inc.\nJames Bixby, CEO and President, SeQual Technologies Inc.\nEdward Radtke, Vice President Sales and Marketing, SeQual Technologies Inc.\nPage 3 of 3","truncated":false,"body_characters":9623}