{"operation":"document","citation":"10-0163","title":"SeQual Technologies, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-02-10","effective_on":null,"summary":"10-0163 response to SeQual Technologies, Inc. concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0163.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0163.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0163","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100163.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave. SE\nWashington. D.C. 20590\nPipeline and Hazardous Materials\nSafety Administration\nFEB 1 02011\nMs. Pamela J. Jackson\nSenior Director, Government and Military\nSeQual Technologies, Inc.\n11436 Sorrento Valley Road\nSan Diego, CA 92121\nReference No. 10-0163\nDear Ms. Jackson:\nThis is in response to your letter regarding the applicability of the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 100-180) to a device that your company calls the SAROSTM\nOxygen System.\nYou state that the SAROSTM Oxygen System is a device that separates oxygen from ambient air\nthrough a process called Pressure Swing Absorption (PSA). Your product was developed in\ncooperation with the US Army Medical Materiel Command to support the oxygen needs of\npatients on a battlefield. This device consists of a lightweight, portable oxygen concentrator with\nan integrated oxygen delivery valve for continuous flow or pulse delivery. The maximum\npressure of the oxygen exerted within the SAROSTM Oxygen System packaging is 23.7 psia\nduring normal operation at 20°C. The device can be powered by multiple power sources,\nincluding AC or DC power, an AC adapter, rechargeable lithium ion batteries, and an auxiliary\nDC power adapter for automotive applications. The battery pack consists of 16, 1.5 ampere-hour\nlithium ion cells, and the total equivalent lithium content of the battery pack is 7.20 grams or 86\nWatt-hours. The lithium ion cells and battery pack have 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\nregulated as a hazardous material under the HMR.\nBased on the information provided, the SAROSTM Oxygen System portable oxygen concentrator\nis not currently subject to the HMR because: (1) the pressure of the oxygen in the device does\nnot exceed 280 kPa absolute (40.6 psia) at 20°C (68 oF); (2) the lithium ion battery used to\noperate the device is excepted from the HMR under § 172.102(c)(1), Special provision 188; (3)\nthe portable oxygen concentrator contains no other materials subject to the HMR; and (4) the\nbattery 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).\n\n<<<PAGE 2>>>\n\nAlthough the exception in § 175.1O(a)(17) would apply to a passenger carrying a SAROSTM\nOxygen System as described above, the approval of the Federal Aviation Administration (FAA)\nis required before it may be used by a passenger onboard an aircraft. The FAA published a final\nrule on July 12, 2005 (70 FR 40155; copy enclosed) regarding these devices. For further\nassistance, you may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier\nOperations Branch (AFS-220) by phone at (202)-267-3732 or email atdavid.catey@faa.gov.In\naddition, even with FAA approval, an air carrier ultimately determines what mayor may not be\ncarried on its aircraft. We suggest that you contact the airlines to ensure that the SAROSTM\nOxygen System may be carried.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\ns+eVeY16\n~ ( 1 ~. I 0 (aX, 1)\nAir The Smart Choice.\n~SEQLJAl\nSeQual Technologies Inc.\n)0-DI(05 11436 Sorrento Valley Road\nSan Diego, CA 92121\nPhone 858.202.3100\nFax 858.558.1915\nwww.sequaLcom\nJuly 22, 2010\nOffice of Hazardous Materials Standards\nPipeline and Hazardous Materials Safety Administration\nU.S. Department of Transportation\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nRe: Classification of SeQual Technologies' Lithium ion Battery and SAROSTM Oxygen System\nTo Whom It May Concern:\nI am writing to request written confirmation from the Pipeline and Hazardous Materials Safety\nAdministration (pHMSA) that the lithium ion battery used in our new SAROSTM Oxygen System is\nnot subject to the U.S. hazardous materials regulations (HMR) pursuant to Special Provision 188 and\nmay be carried onboard passenger aircraft pursuant to 49 CFR § 175.10(a)(17).\nBackground\nThe SeQual SAROS Oxygen System is a device that separates oxygen from ambient air through a\nprocess called Pressure Swing Adsorption (PSA). The product was developed in cooperation with the\nUS Army Medical Materiel Command to support the oxygen needs of the patients on the battlefield.\nThe SAROS provides a solution to address both stationary and portable requirements for oxygen\npatients needing up to 3 LPM full flow operation and up to 96 ml flow in a pulse mode operation. It\nconsists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for\ncontinuous flow or pulse delivery and is capable of being operated directly from an AC or DC power\nsource or from rechargeable lithium ion batteries. It can be recharged and/or powered by a separate\nAC Power Adapter or where standard AC line power is available. A 24 Volt DC Cable or the 12 Volt\nDC cable accessories allow power to be provided by a DC auxiliary power outlet, such as in a motor\nvehicle during transportation. Changeable and rechargeable battery packs are available to provide a\nrange of ambulatory operational time.\nThe SAROS Oxygen System achieves its performance through SeQual's patented Advanced\nTechnology Fractionator (ATF®) technology arid patented variable speed compressor and compressor\ndrive, advanced molecular'sieve materials and rechargeable batteries. This system will expand an\noxygen patient's ability to travel via aircraft and improve the patient's quality of life.\n\n<<<PAGE 4>>>\n\n~SEQUAL\nThe Smart Choice.\nClass 2, Division 2.2 Gas - 49 CFR 173.115\nThe maximum pressure of the oxygen exerted within the SAROS Oxygen System packaging currently\nis 23.7 psia during normal operation at 20° C. This is substantially less than the 40.6 psia at 20° C\nreferenced in 49 CFR 173.115(b)(1) for defining a Division 2.2 gas. Therefore, it is our opinion that\nthe oxygen exerted within the SAROS Oxygen System is not a Division 2.2 gas and thus is not subject\nto the U.S. HMR.\nLithium ion Batteries used in SAROS Oxygen System\nThe SAROS Oxygen System is powered by a lithium ion battery pack that consists of 16, 1.5 amperehour\nlithium ion cells. Therefore, the battery contains an aggregate equivalent lithium content of 7.20\ngrams (or 86 Watt-hours). The cells and battery have been tested pursuant to the requirements of the\nUN Manual of Tests and Criteria.\nIt is our opinion that the lithium ion battery is not subject to the HMR pursuant to Special Provision\n188 because the cells contain not more than 1.5 grams of equivalent lithium content, the battery\ncontains not more than 8 grams of equivalent lithium content, the cells and battery have been tested in\naccordance with the UN Manual ofTests and Criteria and the battery and SAROS Oxygen System will\nbe packed pursuant to the requirements of Special Provision 188 when offered for transport. The\nbattery also meets the exception found in 49 CFR 175.1 O(a) (17) for passengers and crew members.\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 100 Watt-hours to\nbe carried onboard passenger aircraft.\n* * * *\nI trust the information contained herein is sufficient for PHMSA to provide a written determination\nthat the SAROSTM Oxygen System and lithium ion battery used to power it are not subject to the U.S.\nHMR pursuant to Special Provision 188 and they meet the exception found in 49 CFR 175.l0(a)(17)\nfor passengers and crew members. Should you need additional information or have any questions\nregarding our product, please do not hesitate to call me at the contact information below.\nRespectfully,\n.~rM1f1...0ffUl':' (11,Pamela\nJ. Jackson\nSenior Director, Government and Military\nSeQual Technologies Inc.\n11436 Sorrento Valley Road\nSan Diego, CA 92121\nPhone: 858-202-3144\nCell: 760-805-9000\nEmail: pjackson@segua1.com\nPage 2 of2","truncated":false,"body_characters":8214}