To: U.S Department of Transportation
From: Andy Linn
Subject: New

- Portable Oxygen Concentrator manufacturer seeking FAA approval

Dear Sir or Madam:
Please accept this letter as a petition to amend the Federal Aviation Administration’s (FAA) Special Federal Aviation Regulation (SFAR) No. 106 under 14 CFR 121 that allows for the use of certain portable oxygen concentrator (POC) devices on board passenger aircraft. We are specifically requesting that the FAA amend Section 2 and Section 3(a) of SFAR No. 106 by adding VBOXs’ Trooper Oxygen System as one of the approved POC devices for use on passenger aircraft.
Background:
VBOX is a manufacturer of medical oxygen concentrators. We are currently preparing for market introduction of our Trooper TM Oxygen System, a small, lightweight, battery powered POC device for patients with Obstructive Pulmonary Disease (COPD) who require supplemental oxygen therapy. The Trooper TM is designed to address the portable oxygen requirements of patients with prescript ions 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 abili ty to travel on aircraft. A draft of the Trooper System User Manual is attached as Exhibit A. The User Manual is considered “CONFIDENTIAL” at this time and should not be made available to the public.

Note: User Manual quick reference below.

1. Air Travel: pa ges 20

- 23 2. B attery : pages 23

- 24 3. S pecification s: pages 34

- 36
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 pate nted technology, patented pump and valve system, advanced molecular sieve and rechargeable batteries. It provides a patient with Uni ted States Pharmacopeia (USP) 87

- 94% medical grade oxygen.
The Trooper is scheduled for U.S. home care market introduction i n 2013 . 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 4.3 pound portable oxygen concentrator (POC) with battery. With two fully charged batteries the Trooper has dura tion

- of

- use of 5 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 device is intend ed 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 single

- lumen nasal cannula. Typically, most of the users will be di agnosed with chronic obstructive pulmonary disease (COPD).
By adding the VBOX Trooper to the list of approved POC devices patients traveling by aircraft will have the use of a device that is much smaller and much lighter than the currently approved devices . We believe this will be a major benefit to both traveling patients and air services . It will offer those traveling an additional choice and a favorable alternative to the devices currently approved.
The circumstances that support the need for this amendm ent are similar to the circumstances that originally supported the approval of the Inogen One device. As stated in the Final Rule, “There is a critical need to improve service for passengers who have a medical need to travel with medical oxygen. Passengers requiring medical oxygen during air travel have faced significant difficulties obtaining adequate air service. Many carriers do not provide medical oxygen during air travel. Those carriers that do provide the service often charge for the service

- sometimes at a cost that equals the price of a tick et. Additionally, it can be difficult to coordinate service between the carrier and the supplier of medical oxygen to ensure passenger coverage both at the terminal and on the aircraft. Sometimes, the passenger

mus t spend at least part of the time traveling without oxygen due to service problems with the oxygen provider.”
The VBOX Trooper adequately addresses all of those needs and helps to eliminate those service problems.

Summary

We trust the information contained in this petition provides sufficient information for the FAA to determine that the VBOX Trooper Oxygen System is safe to be carried onboard aircraft. We therefore request that Section 2 and Section 3(a) of SFAR No. 106 be amended by adding VBOXs’ Trooper Oxygen System as an approved POC device for use onboard aircraft.
Should you need additional information or have and questions regarding our product, please do not hesit ate to call me at the contact information below.
Respectfully,
Andy Linn linn@vboxinc.com 651

- 207

- 5461

VBOX Inc. 2340 East Co Rd J. White Bear Lake, MN 55110