Atch. 1- Surgical Lights Requirements List.docx

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Steris Harmony AIR A-Series Surgical Lights
Solicitation number
FA2823-25-Q-6002
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The document is a Requirements List for Boom Mounted Surgical Lights, detailing technical specifications for a surgical lighting system for the Department of Defense. The requirements include a ceiling-mounted, configurable LED surgical light with specific performance criteria: minimum 160,000 lux illumination, 360-degree rotation, adjustable color temperature (3,500K-5,000K), Color Rendering Index of 95, and an LED light source with a 40,000-hour lifespan. The system must meet FDA 510(k) clearance, UL/ETL listing, and DoD/DHA acquisition standards.

The related federal contract opportunity (Solicitation Number FA2823-25-Q-6002) is a pre-solicitation Sources Sought/Request for Information from the Air Force Materiel Command, specifically seeking capabilities for Steris HarmonyAIR A-Series Surgical Lights. The procurement targets small businesses (8(a), HUBZone, EDWOSB, WOSB, SDVOSB) and requires technicians with specific Steris equipment training. Interested vendors must submit a 3-page capabilities statement by 4:00 PM CST on 21 July 2025, demonstrating their ability to service these specialized surgical lights with compliance to federal, state, and manufacturer standards.

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Atch. 2- Surgical Lights Salient Characteristics.docx DOCX document

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Text version

Requirements List Boom Mounted Surgical Lights

1. Mounting Type & Configuration

0. Ceiling-mounted surgical lighting system, compatible with government-furnished structural supports and OR infrastructure.

0. Configurable with one single and one dual articulated LED light heads.

0. 360° rotation with multi-pivot arm for unrestricted maneuverability and positioning.

1. Illumination Performance

1. Minimum 160,000 lux at 1 meter with uniform intensity across the light field.

1. Adjustable light intensity via sterile control handle, and wall panel.

1. Shadow reduction system using multiple LED emitters to eliminate obstruction-based dark zones.

1. Auto-intensity feature that automatically maintains constant light intensity even when the light is adjusted or moved during a procedure.

1. Color Accuracy & Customization

2. Color temperature adjustable from 3,500 K to 5,000 K to support diverse surgical environments.

2. Color Rendering Index (CRI) ≥ 95 for true tissue color visualization.

1. Sterility & Infection Control

3. Smooth, sealed light housing with no external fans or exposed fasteners; IP54 or higher preferred.

3. Easy-to-clean surfaces compatible with normal infection control cleaning standards.

1. LED Light Source

4. High-efficiency LED with minimum lifespan of 40,000 hours.

4. No external bulb replacement required; integrated cooling system for thermal stability.

1. Certifications & Compliance

5. FDA 510(k) cleared, UL/ETL listed.

5. Meets or exceeds IEC 60601-2-41, DoD/DHA acquisition standards, and Joint Commission requirements.

5. Listed on an approved ECAT, DAPA, or GSA schedule with national stock number (NSN) if available.

1. Installation

6. Installation to be provided by vendor or vendor supplied sub-contractor.

6. De-Installation of existing lights to be provided by vendor or vendor supplied sub-contractor.

6. Disposal of existing lights will be the responsibility of the government.

1. Warranty & Support

7. Minimum 1-year OEM warranty on all components.

7. U.S.-based service and support team with DHA facility clearance or capability to coordinate with local Biomed.

7. Maintenance manuals to be provided to Hospital Technology Management team member.

6 July 2025
Attachment 1

File details come from the government source that posted it. Updated .