Agreement Data Requirements List (ADRL)

Anesthesia Workstation System (AWS) Prototype Project

Status Active

Author Project Manager Maneuver Medical Systems (PM M2S)

Date September 2026

Version 1.0

Table of Contents

1.0 Background and Purpose

2.0 Deliverable Instructions

3.0 ADRL Matrix

4.0 Notes and Additional Requirements

Agreement Data Requirements List (ADRL) | v1.0

1.0 Background and Purpose

This document outlines the Agreement Data Requirements List (ADRL) for the Anesthesia Workstation

System (AWS) Prototype Project. This prototype effort is executed under the Other Transaction

Authority (OTA) pursuant to 10 U.S.C. § 4022. The AWS is a critical medical device used in deployed field hospitals at Role of Care (ROC) 3. The system enables clinicians to safely deliver and monitor anesthetic agents during surgical and critical care operations in austere and remote operational environments. The deliverables outlined in this ADRL are critical for ensuring the prototype meets all operational, technical, and regulatory requirements, including FDA clearance, cybersecurity compliance, organic BMET maintainability, and MIL-STD-810H environmental survivability.

2.0 Deliverable Instructions

The Performer shall provide the following deliverables in accordance with the specified due dates, frequencies, and formats. Deliverables encompass hardware prototypes, technical manuals, regulatory documentation, training, and programmatic reports. The Agreements Officer Representative (AOR) and designated Government stakeholders will review all submitted data and documentation to ensure adherence to the technical and logistical requirements of the prototype project. All manuals and technical data must support organic maintenance by military Biomedical Equipment Technicians

(BMETs) at Field and Depot levels in accordance with Attachment C — Technical Data Articles Annex.

3.0 ADRL Matrix

ADRL Deliverable Due Date / Frequency

Format / Notes

A-001 Prototype AWS Units (2 per vendor) 120–180 days after award

Physical delivery (per technical specifications)

A-002 User/Operator Manual With unit delivery 1 Physical, 1 Digital per device (English language)

A-003 Maintenance/Service Manual With unit delivery 1 Physical, 1 Digital per device (English language)

A-004 User/Operator Manual — Physical (1) and Digital (1) Maintenance/Service Manual — Physical (1) and Digital (1)

Vendor Proposed

ADRL Deliverable Due Date / Frequency

Format / Notes

A-005 Copyright Release — Copyright release allowing the Government to reproduce and distribute training materials, manuals, and technical data for internal military use.

Vendor Proposed

A-006 Provisioning & NSN Generation — Comprehensive logistics data (e.g., Bill of Materials, CAGE codes, part numbers) required to generate National Stock Numbers (NSNs) for the complete system, major components, and repair parts.

Vendor Proposed

A-007 TAA Compliance Certificate (DFARS 252.225-7020)

With proposal / at award

Signed Document (Trade Agreements Act)

A-008 Training — Up to two (2) On-Site CONUS Operator Sessions

Vendor Proposed Up to 2 Sessions (Approx. 5–10 personnel per session)

A-009 Operational Training Video or Training Site Access

Vendor Proposed Digital delivery or access to training site

A-010 Special Tools List — Vendor identifies specialized tools required for repair/maintenance and makes them available for Government purchase, as applicable.

Vendor Proposed Electronic Document (Identifying tools and procurement sources)

A-011 Cybersecurity / ATO Documentation

— Vendor completes Government-provided RMF documentation, Medical Device and Equipment Risk Assessment (MDERA) supporting cybersecurity compliance and ATO documentation.

Vendor Proposed

A-012 Test Support — Technical Representative

During Government T&E events

Vendor-funded representation

A-013 Recurring Meetings Vendor Proposed Virtual / Teleconference & digital documentation

ADRL Deliverable Due Date / Frequency

Format / Notes

A-014 Supplemental Documentation — all additional reports, manuals, or technical data items

Vendor Proposed

A-015 Final Report — Performance summary, lessons learned, final budget justification.

Vendor Proposed

A-016 Organic Maintenance Support Plan & License (Highly Desired) — Plan outlining how the Government may perform organic repairs utilizing military BMET personnel, to include requested technical manual reproduction rights, schematics access, or voluntary diagnostic software permissions.

Vendor Proposed

A-017 Item Unique Identification (IUID) — Vendor shall mark all tangible prototype hardware deliverables with a MIL-STD-130N compliant 2D Data Matrix and human-readable text using Construct 2 (CAGE, Original Part Number, Serial Number) and provide an electronic IUID/pedigree data report to the Agreements Officer Technical Representative (AOTR) upon milestone delivery.

Vendor Proposed Email / IUID registration confirmation

A-018 Data Rights Assertions (Appendix E)

— Identification and Assertion of Use, Release, or Disclosure Restrictions per 10 U.S.C. 3772

Pre-Award / With Proposal

Completed assertions table (per Attachment C)

4.0 Notes and Additional Requirements

• Language Requirements: All physical and digital technical manuals (A-002, A-003, A-004) must be provided in the English language.

• Data Rights / Organic Maintainability: In accordance with Attachment C — Technical Data Articles

Annex, the Performer grants the Government a perpetual, royalty-free license to reproduce and use all operation and maintenance manuals, schematics, parts lists, and troubleshooting guides for internal training and organic maintenance by military BMETs. Organic maintenance performed in accordance with the provided manuals shall not void the warranty.

• Bi-weekly Meetings (A-013): Meeting agenda, meeting minutes, and all relevant briefing materials will be provided for each bi-weekly meeting. These documents should be shared in advance whenever possible.

• Risk Reporting: The Performer shall proactively notify the AOR of any risks or issues that impact the delivery schedule or technical performance within two (2) business days of identification.

• IUID Marking (A-017): The Performer shall apply one Item Unique Identification (IUID) mark to each

AWS unit. The IUID shall be a compliant 2D Data Matrix placed in a visible, durable, and permanent location on the exterior of the unit. The Performer is responsible for ensuring accuracy, permanence, and readability of the mark, and shall register all required data elements in the DoD

IUID Registry prior to shipment.

• Intellectual Property Assertions (A-018): Vendors must submit completed Intellectual Property

Assertions with their proposal in accordance with Attachment C — Technical Data Articles Annex.