U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 

## JAN 02 2013 Mr. Andy Linn VBOXInc. 2340 East Co Rd J White BearLake, MN 55110 Ref. No.: 12-0245 Dear Mr. Linn: 1200 New JerseyAvenue, SE Washington, D.C. 20590



### This responds to your October 24, 2012 email regardingthe applicability ofthe Hazardous Materials Regulations (HMR; 49 CFR Parts 100-180) to a portable oxygen concentrator (POC) your company manufactures that is knownby the trade name ofthe Trooper Oxygen Concentrator (TrooperTM). You ask whether this device is regulated as a hazardous material under the HMR. You state the TrooperTM is a device that separates oxygen from ambient air through a process called Vacuum SwingAbsorption (VSA). Themaximum operatingpressure ofthe oxygen exerted within the device is less than 5 psig at 20°C (68°F). The device canbe powered usingAC or DC electricity. It

### is equipped with an ACpower cord and abattery pack consisting ofsix 3.1 amp hour (Ah) lithium-ion cells equating to an equivalentlithium content of0.93 grams per cell and 5.58 grams aggregate equivalent lithium content (66.96 watt hour (Wh)). The lithium ion cells and battery packhave been tested pursuant to Subsection 38.3 ofthe United Nations Manual ofTests and Criteria. When offered for transportation the TrooperTMbattery packwill be packaged in a manner to prevent short circuits and, whentransportedby aircraft passengers or crewmembers, the TrooperTM will be carried onboard rather than checked. Based on the information provided in your letter, the TrooperTM POCis not subject to the HMR as a 2.2 non-flammable gas. The lithium-ionbattery packused to operate the device appears to conform to § 172.102( c)(1), Special Provision 188 for the transportation ofsmall lithium cells andbatteries and the POC contains no other hazardous materials. Therefore, the TrooperTM POC is not subject to any other requirements in the HMR. Please note that notwithstandingthe passenger exceptionin§ 175.10(a)(18) ofthe HMR, Special Federal Aviation Regulation 106 (SFAR 106) "Rules for Use ofPortable Oxygen Concentrator Systems on Board Aircraft" apply and are under the purview ofthe Federal AviationAdministration (FAA), not PHMSA. This response letter satisfies only one

### requirement in the FAA approval process before a POC may be operated onboard an aircraft. Youmay contactMs. DKDeaderick inFAA'sFlight Standards Service at (202) 267-7480 for questions regarding FAA's approval process. I hope this information is helpful. Ifyou have further questions, please do not hesitate to contact this office. Sincerely,

Robert Benedict Chief, Standards Development Branch Standards and RulemakingDivisionFrom: Sent: To:

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# Yo)~~f(d Drakeford, Carolyn (PHMSA) 

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# -15 Subject: RE: VBOX Trooper Portable Oxygen Concentrator (POC)- HMR;49 CFR Parts 171-180

Hi Carolyn, We received the following request for aformal letterofinterpretation. Thanks, Victoria

From: linn@vboxinc.com [mailto:linn@vboxinc.com] 

### Sent: Wednesday, October 24, 2012 8:55 AM To: INFOCNTR (PHMSA) Subject: VBOXTrooper Portable Oxygen Concentrator (POC)- HMR;49 CFR Parts 171-180 October 24, 2012 U.S. Department ofTransportation Pipeline and Hazardous Materials Safety Administration 

### Applicability ofthe Hazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR Parts 171-180) Dear Sir or Madam: Please accept this letteras a petition to receive a "Letter of Interpretation "regardingthe applicability ofthe Hazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR Parts 171-180). The FAA requires a PHMSA letterof interpretation stating a POC does notcontain hazardous materials and is not subjecttothe HMR to receive FAA clearance. As such, I have provided the following documents. These documents are considered "CONFIDENTIAL" atthis time and should not be made available tothe public. 

### 1. (1) Trooper User Manual 2. (2) Certificate ofCompliance-Battery Pack 3. (3) R1-768 Test Report-Battery Pack 4. (4) NC1000473 1TRS-RTCA-D0-160E 5. (5) NC1000473 Report-EMC Immunity 6. (6) WC1000472 Report-60601-1-2 7. (7) NAMSA Biological Risk Assessment Background: VBOX is a manufacturerof medical oxygen concentrators. We are currently preparing for market introduction of ourTrooperTM Oxygen System, a small, lightweight, battery powered POC device for patients with Obstructive
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## Y·Pulmonary Disease (COPD) who require supplemental oxygen therapy. The TrooperTM is designed to address the portable oxygen requirements of patients with prescriptions up to 5 LPM in pulse flow mode operation. VBOX's objective is to provide an oxygen system thatwill substantially improve the quality of life ofoxygen patients by increasingtheir mobility both inside and outside oftheir homes, includingtheir abilityto travel on aircraft. VBOX's Trooper Oxygen System separates oxygen from ambient airthrough a process called Vacuum Swing Adsorption (VSA). The Trooperachieves superior performancethough the VSA technology, a patented technology, patented pump and valve system, advanced molecular sieve and rechargeable batteries. It provides a patientwith United States Pharmacopeia (USP) 87-94% medical grade oxygen. The Trooper is scheduled for U.S. home care market introduction in spring 2012. It is an FDA 510(k) pre-market notification cleared device. Our 510(k) number is K121260. The device can be briefly described as a 3.2 pound portable oxygen concentrator (POC) with battery. With two fully charged batteries theTrooper has duration-of-use of7 hours at a setting of2, and 20 breaths per minute. Batteries can be removed for aquick replacement with spare/extra batteries should the patient desire. In addition,the device can be powered by use ofthe AC power cord. The Trooper device has a maximum operating pressure of less than 5 psig at 20°C {68°F). The battery pack contains less than 5.58 g aggregate equivalent lithium content or 66.96 Wh per pack and each pack contains 6 cells. The TrooperTM Oxygen System does not contain any hazardous materials. A biological risk assessment was conducted by an independentthird party and is provided in the attachment as item 7.

The device is intended for use by individuals requiring supplemental oxygen, by and on the order ofa prescribing physician. The userwill be ambulatory. The interfacewith the user will be through astandard singlelumen nasal cannula. Typically, most ofthe users will be diagnosed with chronic obstructive pulmonary disease (COPD). Ifyou have anyfurther questions or require more information, please do not hesitate to contact me. Sincerely, Andy Linn VBOX Inc. 2340 East Co Rd J White Bear Lake, MN 55110 linn@vboxinc.com 651-207-5461 Direct

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