B08-HT942525QE018-Attach1-CODs-CLS-APPs-20250805-Final.pdf

HT942525QE018 – Attachment 1

REQUIREMENTS DOCUMENT:

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

(APPs)

Title: Dermatome Portable, Electric

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

Background: The Army requires a new dermatome to be used in deployed field hospitals in austere environments (Role of Care 2 and 3). The current device is not procurable or supportable. Without a suitable replacement, the Army's ability to effectively cover open wounds through the process of skin grafting in forward-deployed settings will be compromised, impacting Warfighter readiness. The new dermatome shall meet the specifications detailed below.

Purpose: The government anticipates awarding a single contract for four (4) dermatomes to include options for four (4) additional dermatomes. 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(1), Department of Defense, Test Method Standard, Environmental Engineering Considerations and Laboratory Tests.

Government Intent: Following successful operational and environmental testing, in Fiscal Year (FY) 2028, the government intends to procure an estimated 84 dermatomes over a period of up to five (5) years. To streamline delivery to the warfighter, the selected vendor will be highly encouraged to collaborate with the Defense Logistics Agency (DLA) to incorporate the dermatome into the Electronic Catalog (ECAT).

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 device on 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 Parameter

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

# Operational Characteristic Minimum Required Desired Characteristics

1 Food and Drug Administration (FDA) Regulatory Oversight

The Dermatome shall be cleared by the FDA with a 510(k) approval if it is a Class II medical device.

If the system is a Class I medical device, it shall be registered with the FDA for human use.

Minimum Requirement

2 Core Function The system shall be used in skin grafting, producing thin slices of skin at precise thickness from a donor area to use them for making skin grafts.

Minimum Requirement

3 Operating Pressure, psi The Dermatome shall have an operating pressure no less than100 psi. Minimum Requirement

4 Max Oscillating Speed, cycles/min

The Dermatome shall have a max oscillating speed, cycles/mins of 6,500 Minimum Requirement

5 Cutting Width, in The Dermatome shall have a cutting width of 1-4 in Minimum Requirement

6 Cutting Thickness, mm The Dermatome shall have cutting ranges from 0.000” – 0.030” (0.00mm – 0.76mm) Minimum Requirement

7 Cutting Thickness Increments, mm The Dermatome shall cut in thicknesses of 0.1-0.5mm Minimum Requirement

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

# Operational Characteristic Minimum Required Desired Characteristics

8 Power

The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz.

The system shall include auto-detection and simultaneous switching capability between both voltage ranges.

Additionally, if battery charging is necessary, the device shall support charging for both voltage ranges

* Note: Balanced power is a process that eliminates noise or distortion from incoming electrical current.

Minimum Requirement

9 Operational Cube and Weight The system shall be no larger than 0.20 cu ft, 6.3lbs Minimum Requirement

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

# Logistical Characteristic Minimum Required Desired Characteristics

1 Repair Parts Support

The vendor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.

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

2 Warranty

The vendor shall provide a warranty for at least (1) year. This warranty shall include all parts, In-House labor, and technical support during the warranty period.

Desired the vendor provides a warranty for at least 3 years. This warranty shall include all parts, In-house labor, and technical support during the warranty

3 Manuals The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system.

Minimum Requirement

4 Trade Agreements Act (TAA) Compliance

The device, accessories, and repair parts shall be compliant with the Trade Agreements Act.

The vendor is required to complete and submit the DFARS Provision 252.225- 7020, Trade Agreements Certificate.

Minimum Requirement

5 Training

The vendor shall provide on-site Continental United States (CONUS) operator training on an agreed upon date and location between the vendor and the government for approximately 5-10 people.

Minimum Requirement

The vendor shall provide one operational video training for each device.

6 Special Tools

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

The Dermatome doesn’t require special tools for maintenance or repairs

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

Risk Management Framework (RMF) / Authority to Operate (ATO)

The vendor shall complete the provided documentation required by the Government to complete Risk Management Framework (RMF) procedures and Authority to Operate (ATO) activities for cybersecurity protections.

Minimum Requirement

8 Network Capabilities

The system shall be a standalone device that operates independently and does not require Wi-Fi or internet connectivity for functionality.

Minimum Requirement

9 Copyright Release

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

Minimum Requirement

10 Reusable Harden Transport Case

The Dermatome 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

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

11 Maintenance Requirement

For the fielding contract, if required the vendor shall provide Lifecycle Sustainment Plan and the Lifecycle Cost Estimate and schedule for Original Equipment Manufacturer (OEM) only repairs/maintenance.

Minimum Requirement

12 Delivery The vendor shall deliver the Dermatome 120-150 days after award. Minimum Requirement

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

13 Packaging

The vendor shall provide the Dermatome 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

• 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.

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

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

# Additional Performance Parameter Desired Characteristic

1 Support of Device

For possible future purchases, if the vendor’s device is selected, the vendor will ensure the devices are able to be procured for a minimum of five years and will support the parts for an additional five years. The vendor shall provide supportability, including maintenance, technical documentation, components and access to OEM or government-provided sustainment support.

2 Defense Logistics Agency, Electronic Catalog (ECAT)

The vendor currently has a DLA ECAT contract or is willing to work with a Prime Vendor to get the device added to electronic catalog (ECAT) to provide a process that streamlines the procurement, allowing users to easily search for items, place orders, and track shipments, ultimately saving time and money while ensuring all branches have access to the same standardized products

4. Delivery Timeframe: 120-150 days after award