A02-Portable-Oxygen-Carrier-COGM-RFI-Attach3-CPP-Draft.pdf

Portable Oxygen (O2) Compact Oxygen Generation Medical (COGM) Consolidated Performance Parameters (CPPs)

1. Overview

1.1 System Description

The Portable Oxygen (O2) capability is a Family of Systems (FoS) that will consist of multiple devices in varying form factors to provide Department of Defense (DoD) medical providers with the ability to enhance the delivery of oxygen to patients throughout the continuum of care; from Role 1 through Role 3, including en route care. The Compact Oxygen Generation Medical (COGM) solution is an essential capability of the FoS meant to be fielded by all Services to address oxygen generation gaps throughout the care continuum. This solution is a small device that will be capable of generating 3-7 liters per minute (lpm) of medical oxygen to provide to patients. In addition to operating in austere, far-forward conditions, the system must be lightweight, of low power consumption, provide battery backup power, and be a size that allows it to be secured into existing oxygen storage racks in evacuation vehicles.

1.2 Performance Parameter Definitions

Each parameter articulates a performance attribute considered critical or desirable for the development of an effective military capability. Performance parameters categorized as “Critical Parameters” are non-negotiable and essential to the device. Performance parameters categorized as “Desired Characteristics” are sought but are not identified as critical or essential.

Threshold-level parameters indicate minimums for performance.

Objective-level parameters indicate desired performance.

2. COGM Parameters

Performance parameters are summarized into critical and desired parameters in sections 2.1 and 2.2.

2.1 Critical Parameters

At the conclusion of developmental efforts in Phase I and Phase II, the following performance parameters must be met for the device to be considered acceptable.

Number Parameter Development Threshold (T) Development Objective (O)

1 FDA Approval

The Food and Drug Administration (FDA) will be the approving authority for the uses of this device as stated herein

T=O

2 Airworthiness Release/Safe-to-fly

The COGM will attain airworthiness/safe-to-fly release on Service aeromedical evacuation aircraft of opportunity.

T=O

2.2 Desired Characteristics

The following consolidated performance parameters (CPPs) are desired for the device.

1 Quality of Oxygen Will generate oxygen, USP, 93+/- 3% Will generate oxygen, USP, 99%

2 Capture/Recycle

For products prone to oxygen supply depletion through natural off-gassing; shall have the option/ability to capture and reutilize the released oxygen in order to reduce waste.

T=O

3 MOSA Integration

Portable Oxygen FoS shall utilize standard fittings and tubing for oxygen generation and supply, integrate with Aeromedical Evacuation devices/systems as needed, wired integration only.

Portable Oxygen FoS shall utilize standard fittings and tubing for oxygen generation and supply, and integrate with Aeromedical Evacuation devices/systems as needed, both wired and wireless integration.

4 Exportability

The product, inclusive of support products, will be exportable to close allies and partners (i.e., FVEY) IAW the Conventional Arms Transfer Policy and other relevant export regulations.

The product, inclusive of support products, will be exportable to all allies and partners IAW the Conventional Arms Transfer Policy and other relevant export regulations.

Storage Temperature

The Portable Oxygen FoS capability must not be affected under storage conditions from -28° F (-33° C) to +160°F (+71° C).

T=O

Embedded Instrumentation

The Portable Oxygen FoS capability will have embedded diagnostics that can identify errors or faults down to the major sub-component level.

T=O

Environmental, Safety, and Occupational Health (ESOH)

The Portable Oxygen FoS will incorporate safety, health and environmental planning to meet legislative and regulatory requirements, and design considerations should evaluate to improve upon root-causes of past mishaps to ensure device integrity throughout the manufacturing, maintenance and use life-cycle.

T=O

Natural Environmental

The Portable Oxygen FoS will be capable of performing day and night operations without degradation when exposed to adverse environmental conditions.

9 Oxygen Flow The system will have an adjustable oxygen flow of 3-7 liters per minute (lpm).

T=O

Key material/ special parts durability and longevity

Key materials (ex. zeolite filters) shall not degrade or require maintenance more frequently than 12 months.

Key materials (ex. zeolite filters) shall not degrade or require maintenance more frequently than 12 months. For Pressure Swing Adsorption concentrators, molecular sieve filters shall be user-level replaceable.

Bio Medical Equipment Technician (BMET) Training

System shall be serviceable and maintainable by BMETs with standard DoD BMET training following the OEM’s Service Manual without voiding the manufacturer’s warranty with no specialized OEM specific training.

T=O

12 Closed Loop Control Integration

Shall have the option/ability to interface, be controlled by closed-loop-control technologies.

T=O

13 Software Updates

System software that may require modification during system life shall be upgradable in the field by military BMETs using a computer interface, the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. All software updates must be regression tested, and available software updates must not render existing fielded items non-working, if updates are not yet installed.

T=O

14 Supportability

Shall support the system with parts, consumables, supplies, and software updates available and software updates for purchase to make repairs for the determined lifecycle.

T=O

15 Reliability 350 hours mean time between system abort.

462 hours mean time between system abort.

Maximum Time to Repair for Mechanic Field Level Maintenance

Maximum Time To Repair for 90% (MaxTTR-90) of unscheduled Field Level Maintenance performed by Military Occupational Specialty (MOS) Technician(s) of 2 clock hours.

Maximum Time To Repair for 90% (MaxTTR-90) of unscheduled Field Level Maintenance performed by MOS Technician(s) of 1 clock hour.

17 Net Ready

The COGM will be able to interface with closed loop control systems on a local network by a wired connection.

The COGM will be able to interface with closed loop control systems on a controlled network by a wireless connection with the ability to switch wireless connectivity on/off

18 Power The COGM will operate 110 / 220 VAC, 60 - 400 Hz and 10 – 28

VDC.

T=O

19 Battery Backup

The COGM will have a rechargeable battery capable of operating 2 hours at ambient room temperature if power is lost and the ability to utilize vehicle battery power. Battery shall recharge when external power is applied without impeding production of oxygen.

The COGM will have a rechargeable battery capable of operating 3 hours at ambient room temperature if power is lost and the ability to utilize vehicle battery power. Batteries will be hot swappable. Battery shall recharge when external power is applied without impeding production of oxygen.

20 Weight The weight of the COGM will be ≤24 pounds.

The weight of the COGM will be ≤15 pounds.

21 Size

The COGM will be of a size that allows it to be safely secured into a storage space with a diameter of 4.3 inches and a length of 19 inches.

T=O

22 Visual Indicator

The COGM will utilize a button based physical interface and a visual interface to display rate, pressure, battery life, quantity remaining, and time to empty at current flow rate.

T=O

Environmental factors:

Moisture/Humidity

The COGM and its components will be able to survive storage, transit, and operation in an environment of 95%+ humidity at a temperature of 106°F for a duration of 24 hours with no degradation to internal and external components, electronics, and filters.