U.S. Department 

of Transportation 

Pipeline and Hazardous 

Materials Safety 

Administration 

JAN 0 2 2013 

Mr. Andy Linn 

VBOXInc. 

2340 East Co Rd J 

White Bear Lake, MN 55110 

Ref. No.: 12-0245 

Dear Mr. Linn: 

1200 New Jersey Avenue, SE 

Washington, D.C. 20590 

This responds to your October 24, 2012 email regarding the applicability of the Hazardous 

Materials Regulations (HMR; 49 CFR Parts 100-180) to a portable oxygen concentrator 

(POC) your company manufactures that is known by the trade name of the 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 Swing Absorption (VSA). The maximum operating pressure of the 

oxygen exerted within the device is less than 5 psig at 20°C (68°F). The device can be 

powered using AC or DC electricity. It is equipped with an AC power cord and a battery 

pack consisting of six 3.1 amp hour (Ah) lithium-ion cells equating to an equivalent lithium 

content of 0.93 grams per cell and 5.58 grams aggregate equivalent lithium content (66.96 

watt hour (Wh)). The lithium ion cells and battery pack have been tested pursuant to Subsection 38.3 of the United Nations Manual of Tests and Criteria. When offered for 

transportation the TrooperTM battery pack will be packaged in a manner to prevent short 

circuits and, when transported by aircraft passengers or crewmembers, the TrooperTM will be 

carried onboard rather than checked. 

Based on the information provided in your letter, the TrooperTM POC is not subject to the 

HMR as a 2.2 non-flammable gas. The lithium-ion battery pack used to operate the device 

appears to conform to § 172.102( c )(1 ), Special Provision 188 for the transportation of small 

lithium cells and batteries 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 notwithstanding the passenger exception in§ 175.10(a)(18) of the HMR, 

Special Federal Aviation Regulation 106 (SF AR 106) "Rules for Use of Portable Oxygen 

Concentrator Systems on Board Aircraft" apply and are under the purview of the Federal 

Aviation Administration (FAA), not PHMSA. This response letter satisfies only one 
requirement in the FAA approval process before a POC may be operated onboard an 

aircraft. You may contact Ms. DK Deaderick in FAA's Flight Standards Service at 

(202) 267-7480 for questions regarding FAA's approval process. 

I hope this information is helpful. If you have further questions, please do not hesitate to 

contact this office. 

Sincerely, 

Robert Benedict 

Chief, Standards Development Branch 

Standards and Rulemaking Division 
From: 

Sent: 

To: 

~:U%~~;,~~~~~J. 2012 1 58 PM orfah k C1.3.1e n..z Yo)~~f(d Drakeford, Carolyn (PHMSA) J - o/. -15 

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

Hi Carolyn, 

We received the following request for a formal letter of interpretation. 

Thanks, 

Victoria 

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

Sent: Wednesday, October 24, 2012 8:55 AM 

To: INFOCNTR (PHMSA) 

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

October 24, 2012 

U.S. Department of Transportation 

Pipeline and Hazardous Materials Safety Administration 

Applicability of the Hazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR 

Parts 171-180) 

Dear Sir or Madam: 

Please accept this letter as a petition to receive a "Letter of Interpretation "regarding the applicability of the 

Hazardous Materials Regulations to a portable oxygen concentrator (POC) (HMR; 49 CFR Parts 171-180). The 

FAA requires a PHMSA letter of interpretation stating a POC does not contain hazardous materials and is not 

subject to the HMR to receive FAA clearance. As such, I have provided the following documents. These 

documents are considered "CONFIDENTIAL" at this time and should not be made available to the public. 

1. (1) Trooper User Manual 

2. (2) Certificate of Compliance-Battery Pack 

3. (3) R1-768 Test Report-Battery Pack 

4. (4) NC1000473 1 TRS-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 manufacturer of medical oxygen concentrators. We are currently preparing for market introduction of 

our TrooperTM Oxygen System, a small, lightweight, battery powered POC device for patients with Obstructive 

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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 that will substantially improve the quality of life of oxygen patients by 

increasing their mobility both inside and outside of their homes, including their ability to travel on aircraft. 

VBOX's Trooper Oxygen System separates oxygen from ambient air through a process called Vacuum Swing 

Adsorption (VSA). The Trooper achieves superior performance though the VSA technology, a patented 

technology, patented pump and valve system, advanced molecular sieve and rechargeable batteries. It provides 

a patient with 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 the Trooper has duration-of-use of 7 hours at a setting of 2, and 20 breaths per minute. 

Batteries can be removed for a quick replacement with spare/extra batteries should the patient desire. In 

addition, the device can be powered by use of the 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 independent third 

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 of a 

prescribing physician. The user will be ambulatory. The interface with the user will be through a standard singlelumen nasal cannula. Typically, most of the users will be diagnosed with chronic obstructive pulmonary disease 

(COPD). 

If you have any further 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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