{"operation":"document","citation":"12-0245","title":"VBOX Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-01-02","effective_on":null,"summary":"12-0245 response to VBOX Inc. concerning 173.185, 175.10.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0245.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0245.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0245","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120245.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nJAN 0 2 2013\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMr. Andy Linn\nVBOXInc.\n2340 East Co Rd J\nWhite Bear Lake, MN 55110\nRef. No.: 12-0245\nDear Mr. Linn:\nThis responds to your October 24, 2012 email regarding the applicability of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 100-180) to a portable oxygen concentrator\n(POC) your company manufactures that is known by the trade name of the Trooper Oxygen\nConcentrator (Trooper™). You ask whether this device is regulated as a hazardous material\nunder the HMR.\nYou state the Trooper™ is a device that separates oxygen from ambient air through a\nprocess called Vacuum Swing Absorption (VSA). The maximum operating pressure of the\noxygen exerted within the device is less than 5 psig at 20°C (68°F). The device can be\npowered using AC or DC electricity. It is equipped with an AC power cord and a battery\npack consisting of six 3.1 amp hour (Ah) lithium-ion cells equating to an equivalent lithium\ncontent of 0.93 grams per cell and 5.58 grams aggregate equivalent lithium content (66.96\nwatt hour (Wh)). The lithium ion cells and battery pack have been tested pursuant to Sub-\nsection 38.3 of the United Nations Manual of Tests and Criteria. When offered for\ntransportation the Trooper™ battery pack will be packaged in a manner to prevent short\ncircuits and, when transported by aircraft passengers or crewmembers, the Trooper™ will be\ncarried onboard rather than checked.\nBased on the information provided in your letter, the Trooper™ POC is not subject to the\nHMR as a 2.2 non-flammable gas. The lithium-ion battery pack used to operate the device\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 Trooper™ POC 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 (SF AR 106) \"Rules for Use of Portable Oxygen\nConcentrator Systems on Board Aircraft\" apply and are under the purview of the Federal\nAviation Administration (FAA), not PHMSA. This response letter satisfies only one\n\n<<<PAGE 2>>>\n\nrequirement in the FAA approval process before a POC may be operated onboard 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 hope this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nSincerely,\nRobert Benedict\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nFrom:\nSent:\nTo:\nSubject: ~:U%~~;,~~~~~J. 2012 1 58 PM orfah k C1.3.1e n..z Yo)~~f(d\nDrakeford, Carolyn (PHMSA) J - o/. -15\nRE: VBOX Trooper Portable Oxygen Concentrator (POC)- HMR;49 CFR Parts 171-180\nY·\nHi Carolyn,\nWe received the following request for a formal letter of interpretation.\nThanks,\nVictoria\nFrom: linn@vboxinc.com [mailto:linn@vboxinc.com]\nSent: Wednesday, October 24, 2012 8:55 AM\nTo: INFOCNTR (PHMSA)\nSubject: VBOX Trooper Portable Oxygen Concentrator (POC)- HMR;49 CFR Parts 171-180\nOctober 24, 2012\nU.S. Department of Transportation\nPipeline and Hazardous Materials Safety Administration\nApplicability of the Hazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR\nParts 171-180)\nDear Sir or Madam:\nPlease accept this letter as a petition to receive a \"Letter of Interpretation \"regarding the applicability of the\nHazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR Parts 171-180). The\nFAA requires a PHMSA letter of interpretation stating a POC does not contain hazardous materials and is not\nsubject to the HMR to receive FAA clearance. As such, I have provided the following documents. These\ndocuments are considered \"CONFIDENTIAL\" at this time and should not be made available to the public.\n1. (1) Trooper User Manual\n2. (2) Certificate of Compliance-Battery Pack\n3. (3) R1-768 Test Report-Battery Pack\n4. (4) NC1000473 1 TRS-RTCA-D0-160E\n5. (5) NC1000473 Report-EMC Immunity\n6. (6) WC1000472 Report-60601-1-2\n7. (7) NAMSA Biological Risk Assessment\nBackground:\nVBOX is a manufacturer of medical oxygen concentrators. We are currently preparing for market introduction of\nour Trooper™ Oxygen System, a small, lightweight, battery powered POC device for patients with Obstructive\n1\n\n<<<PAGE 4>>>\n\nPulmonary Disease (COPD) who require supplemental oxygen therapy. The Trooper™ is designed to address the\nportable oxygen requirements of patients with prescriptions up to 5 LPM in pulse flow mode operation. VBOX's\nobjective is to provide an oxygen system that will substantially improve the quality of life of oxygen patients by\nincreasing their mobility both inside and outside of their homes, including their ability to travel on aircraft.\nVBOX's Trooper Oxygen System separates oxygen from ambient air through a process called Vacuum Swing\nAdsorption (VSA). The Trooper achieves superior performance though the VSA technology, a patented\ntechnology, patented pump and valve system, advanced molecular sieve and rechargeable batteries. It provides\na patient with United States Pharmacopeia (USP) 87-94% medical grade oxygen.\nThe Trooper is scheduled for U.S. home care market introduction in spring 2012. It is an FDA 510(k) pre-market\nnotification cleared device. Our 510(k) number is K121260.\nThe device can be briefly described as a 3.2 pound portable oxygen concentrator (POC) with battery. With two\nfully charged batteries the Trooper has duration-of-use of 7 hours at a setting of 2, and 20 breaths per minute.\nBatteries can be removed for a quick replacement with spare/extra batteries should the patient desire. In\naddition, the device can be powered by use of the AC power cord. The Trooper device has a maximum\noperating pressure of less than 5 psig at 20°C {68°F). The battery pack contains less than 5.58 g aggregate\nequivalent lithium content or 66.96 Wh per pack and each pack contains 6 cells. The Trooper™ Oxygen System\ndoes not contain any hazardous materials. A biological risk assessment was conducted by an independent third\nparty and is provided in the attachment as item 7.\nThe device is intended for use by individuals requiring supplemental oxygen, by and on the order of a\nprescribing physician. The user will be ambulatory. The interface with the user will be through a standard single-\nlumen nasal cannula. Typically, most of the users will be diagnosed with chronic obstructive pulmonary disease\n(COPD).\nIf you have any further questions or require more information, please do not hesitate to contact me.\nSincerely,\nAndy Linn\nVBOX Inc.\n2340 East Co Rd J\nWhite Bear Lake, MN 55110\nlinn@vboxinc.com\n651-207-5461 Direct\n2","truncated":false,"body_characters":6913}