Atch. 3- Requirements List.pdf
PDF 136 KB Posted
- Attached to
- Operating Room Boom Mounted Surgical Lights
- Solicitation number
- FA282325Q0063
About this file
This document is a Requirements List for a Request for Quote (RFQ) FA2823-25-Q-0063 for Boom Mounted Surgical Lights. The requirements specify a ceiling-mounted surgical lighting system with advanced features including one single and one dual articulated LED light heads, 360° rotation, and minimum 160,000 lux illumination at 1 meter. Key technical specifications include color temperature adjustability from 3,500 K to 5,000 K, Color Rendering Index ≥ 95, smooth sealed light housing, and high-efficiency LED with 40,000-hour minimum lifespan.
The solicitation requires FDA 510(k) clearance, UL/ETL listing, and compliance with IEC 60601-2-41 and DoD/DHA acquisition standards. Installation will be provided by the vendor or vendor-supplied sub-contractor, including de-installation of existing lights. The vendor must offer a minimum 1-year OEM warranty, provide a U.S.-based service and support team with DHA facility clearance, and supply maintenance manuals to the Hospital Technology Management team. The government will handle disposal of existing lights.
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Text version
Atch. 3- Requirements List
RFQ- FA2823-25-Q-0063
1 | P a g e
Requirements List Boom Mounted Surgical Lights
FA2823-25-Q-0063
1. Mounting Type & Configuration o Ceiling-mounted surgical lighting system, compatible with government-furnished structural supports and OR infrastructure.
o Configurable with one single and one dual articulated LED light heads.
o 360° rotation with multi-pivot arm for unrestricted maneuverability and positioning.
2. Illumination Performance o Minimum 160,000 lux at 1 meter with uniform intensity across the light field.
o Adjustable light intensity via sterile control handle, and wall panel.
o Shadow reduction system using multiple LED emitters to eliminate obstruction-based dark zones.
o Auto-intensity feature that automatically maintains constant light intensity even when the light is adjusted or moved during a procedure.
3. Color Accuracy & Customization o Color temperature adjustable from 3,500 K to 5,000 K to support diverse surgical environments.
o Color Rendering Index (CRI) ≥ 95 for true tissue color visualization.
4. Sterility & Infection Control o Smooth, sealed light housing with no external fans or exposed fasteners; IP54 or higher preferred.
o Easy-to-clean surfaces compatible with normal infection control cleaning standards.
5. LED Light Source o High-efficiency LED with minimum lifespan of 40,000 hours.
o No external bulb replacement required, integrated cooling system for thermal stability.
6. Certifications & Compliance o FDA 510(k) cleared, UL/ETL listed.
o Meets or exceeds IEC 60601-2-41, DoD/DHA acquisition standards, and Joint
Commission requirements.
o Listed on an approved ECAT, DAPA, or GSA schedule with national stock number (NSN) if available.
7. Installation o Installation to be provided by vendor or vendor supplied sub-contractor.
Atch. 3- Requirements List
RFQ- FA2823-25-Q-0063
2 | P a g e o De-Installation of existing lights to be provided by vendor or vendor supplied sub-contractor.
o Disposal of existing lights will be the responsibility of the government.
8. Warranty & Support o Minimum 1-year OEM warranty on all components.
o U.S.-based service and support team with DHA facility clearance or capability to coordinate with local Biomed.
o Maintenance manuals to be provided to Hospital Technology Management team member.
File details come from the government source that posted it. Updated .