Salient Characteristics - Orthopedic LED Lighting System.pdf
PDF 113 KB Posted
- Attached to
- Surgical LED Lighting System
- Solicitation number
- W81K00-26-Q-A123
- Issued by
-
Department of the Army Medical Command
About this file
This document is a salient characteristics specification for a surgical LED lighting system. The system must provide deep-cavity illumination with minimal shadows utilizing unique reflector technology and a center sterile handle for easy adjustments to intensity, focus, and positioning. The lighting must deliver white light at 4500K color temperature and be equipped with energy-efficient LEDs rated for a 40,000-hour lifespan. The system must feature 110° vertical travel, 360° rotation, and drift-free stability for versatility across various surgical procedures, along with wall-mounted controls for intensity and color temperature adjustments.
The system must operate on 100-240VAC, 148-240VA power at 50/60 Hz, single phase. Operator training, consumable or spare parts inventory, and special calibration equipment are not required; however, quality history, supportability, ease of maintenance and repair, and regional support and service considerations are mandatory. The equipment must hold FDA certifications or 510K numbers, JECETC/JAC certification, and demonstrate conformance to National/International standards including ASTM, ISO, CSA, UL, and NFPA. Compliance with MIL-STDs is required if applicable. The system is not designated as a Patient Movement Item.
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Text version
Surgical LED Lighting System - Salient Characteristics:
Minimum Clinical Performance Requirements:
• Illumination and Focus: Provides deep-cavity illumination with minimal shadows, thanks to unique reflector technology. The center sterile handle allows for easy adjustments in intensity, focus, and positioning.
• Color Temperature: white light and 4500K for bright, white light-tailored to different procedures.
• Energy Efficiency: Equipped with energy-efficient LEDs that have a lifespan of 40,000 hours.
• Mobility and Stability: Features 110° vertical travel, 360° rotation, and drift-free stability, making it versatile for various procedures.
• Control Options: Includes wall-mounted controls for intensity and color temperature adjustments.
Source Considerations
- Power source: I 00-240VAC, l 48-240VA, 50/60 Hz, 1 phase
- Voltage requirements: N/A
Biomedical Tech Considerations
Operator Training requirements: NO Consumable/Spare/Repair parts inventory considerations: NO Special Calibration Equipment: NO Quality history/Supportability considerations: YES Ease of Maintenance/repair considerations: YES Regional Support and Service considerations: YES
Certifications
- FDA certifications or 51OK numbers that the equipment/system may hold: YES
- Patient Movement Item (PMI) designation if applicable: N/A
- JECETC/JAC certification that the equipment/system may hold: YES
- Conformance to National/International standards such as ASTM, ISO, CSA, UL, NFPA, etc: YES
- Conformance to MIL-STDs if they are required
| Minimum Clinical Performance Requirements: |
| Source Considerations |
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