REQUIREMENTS DOCUMENT:

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

Parameter (APPs)

Title: Portable Oxygen Generator System (POGS)

Requiring Activity/ Agency Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD)

Background: The Army requires a new Portable Oxygen Generator System (POGS) for deployed Role of Care 3. This critical device is essential to provide sufficient 93 percent oxygen and compressed air at 50 pounds per square inch (PSI) to patients, operate anesthesia devices in the operating room, and patient ventilators in pre- and post-op and to fill high pressure oxygen cylinders for patient transport and system backup. Without a suitable replacement, the Army's ability to provide effective medical care in forward-deployed settings will be compromised, impacting Warfighter readiness. The new POGS must meet the specifications detailed below.

Purpose: The government anticipates awarding a contract for four (4) POGS per vendor. These units will undergo operational testing conducted by the Medical Test Evaluation Activity and environmental testing in accordance with Military Standard (Mil-STD) 810-H.

Government Intent: Following successful operational and environmental testing in Fiscal Year (FY) 26, the government may procure an estimated amount of 304 centrifuges over a period of up to 5 years. To streamline delivery to the warfighter, the selected vendor will be expected to collaborate with the Defense Logistics Agency (DLA) to incorporate the POGS into the Electronic Catalog (ECAT) or Prime Vendor Contract.

ECAT is the Department of Defense's primary online procurement system, providing access to millions of items with associated National Stock Numbers (NSNs). Listing the POGS in ECAT will ensure efficient ordering, tracking, and standardized access for all branches of the military. Vendors can find information on working with ECAT at https://www.dla.mil/Troop-Support/Medical/ECAT/. For specific ECAT-related questions, please contact the ECAT Help Desk at dscpecathelp@dla.mil.

https://www.dla.mil/Troop-Support/Medical/ECAT/ mailto:dscpecathelp@dla.mil

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

1.Critical Operational Device Specifications: The following are essential characteristics, and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.

# Operational Characteristic Minimum Required Desired Characteristics

Food and Drug Administration (FDA) Regulatory Oversight

The system must be cleared by the FDA with a 510(k) approval for human use if it is a Class II medical device. If the system is Class I medical device, it must be registered with the FDA for human use.

Minimum Requirement

Power

The Power supply shall provide a balanced power source for the device supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz. It must include auto-detection and simultaneously switching capability between. Additionally, if battery charging is necessary, the device must support charging for both voltage ranges.

Minimum Requirement

Oxygen Concentration

The system shall be able to supply oxygen at a concentration of at least 93%+/- 3 %

USP

Weight The system shall weigh no more than

300lbs The system shall weigh less than 200lbs.

Oxygen Demand for Anesthesia/Ventilator Unit-Compatibility

The system shall generate medical grades oxygen at a flow rate of 30 LPM, meeting USP requirements for 93%± 3% oxygen purity, and deliver it at 50 PSI to support the operation of anesthesia equipment and ventilators

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

6 Portability The system shall be four-person portable, compact, reliable, completely self-contained

Two-person portable, compact, reliable, completely self-contained

7 Monitors and Alarms The system shall include the following alarms with the ability to silence for noise discipline: Power failure, Carbon Monoxide, Dew Point Monitor, Purity

2. Critical Logistical Specifications: The following are essential logistical characteristics, and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.

# Logistical Characteristic Minimum Required Desired Characteristics

1 Trade Agreements Act (TAA) Compliance

Both the device and its repair parts must be compliant with the Trade Agreements Act (TAA).

The vendor is required to complete and submit the attached TAA compliance verification sheet (Attachment 2).

Minimum Requirement

2 Repair Parts Support

The vendor must provide a comprehensive list of all repair parts, clearly identifying those deemed high-failure items (as determined by the Original Equipment Manufacturer (OEM) and government subject matter experts).

For each part, the list must specify availability, whether it is proprietary, and how it can be procured.

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

3 Maintenance Requirement The device shall not have any proprietary-scheduled maintenance actions that occur more than once per year.

Minimum Requirement

4 Special Tools

The vendor must identify any specialized tools required for repair or maintenance of the equipment and make these tools available for purchase.

Minimum Requirement

5 Manuals

For each system delivered, the vendor must provide one physical and one digital copy of both the User/Operator Manual and the Maintenance/Service Manual.

Minimum Requirement

6 Training

The vendor shall provide operator and maintainer training, either through video tutorials or on-site instruction, upon government request.

Minimum Requirement

Risk Management Framework (RMF) / Authority to Operate

(ATO)

If deemed relevant, the vendor shall provide supporting documentation as required by the client to complete Risk Management Framework (RMF) procedures and Authority to Operate (ATO) activities for cybersecurity protections.

Minimum Requirement

8 Copyright Release

The vendors will provide an operational and maintenance copyright/ distribution release for supporting Army technical manuals to be distributed throughout the force.

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

9 Reusable Harden Transport Case

The device shall be configured in one or multiple reusable hardened transport cases (i.e. pelican or harden) with protective foam, designed to meet military standard MIL-STD810H (1) Paragraph:

• 501.7 High Temperature

• 502.7 Low Temperatures

• 506.6 Rain

• 514.8 Vibration

• 516.8 Shock

Minimum Requirement

10 Warranty The vendor must provide a 1-year manufacturer warranty.

Vendor provides options for additional warranty services after 1 year manufacturer warranty

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

11 Packaging

The supplier shall provide the device with all its components and accessories packed safely and securely in self-contained hardcases. The cases shall have approved marked data plates with the following information:

• Item Unique Identification (IUID) on each system/unit, in accordance with Defense Federal Acquisition Regulation Supplement 252.211- 7003, IUID and Valuation, December 2013

• Shall include a list of case contents with picture showing location and position of item in the case.

Inserts shall be of closed-cell foam, or similar insulation, and protective material capable of sustaining the system throughout transport and environmental conditions.

Minimum Requirement

12 Delivery The vendor shall deliver the system 30-60 days after award Minimum Requirement

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance

3. Additional Performance Parameter: The following are additional performance parameters that are not required, but desired by the government

# Additional Performance Parameter Desired Characteristic

1 Cylinder filling capability The system must be capable of refilling a size “D” cylinder at a rate of no more than 12 minutes per cylinder.

4. Delivery Location

Attn:

5. Delivery Timeframe: 30-60 days after award