6515--Medtronic brand name or equal- ENT Surgical Navigation System

Medtronic brand name or equal equipment. Medtronic part numbers are reference only and that equivalency is determined solely by salients.

1. Scope: Contractor shall provide all shipping, labor, tools, training, equipment, installation, delivery, software, personnel, integration, validation, and training for a new brand name or equal Medtronic ENT Surgical Navigation System (cart or tower‑integrated) to support Functional Endoscopic Sinus Surgery (FESS), rhinology procedures, and anterior skull‑base surgical interventions.


2. System Requirements: Brand name or equal ENT Navigation System shall meet the following minimum requirements:


3. Navigation Technology
   
   
   
   • Electromagnetic (EM) and/or optical tracking capability.
   
   
   • Ability to track multiple surgical instruments simultaneously.
   
   
   • Accuracy suitable for ENT/skull‑base procedures (≤ 2 mm typical).
   
   
   
   


4. Imaging Compatibility
   
   
   
   • Full Digital Imaging and Communications in Medicine compatibility for Computed Tomography and Magnetic Resonance Imaging datasets.
   
   
   • Ability to import, display, and register patient imaging.
   
   
   • Support for automatic, manual, and landmark-based registration.
   
   
   
   


5. Operating Room Integration
   
   
   
   • Integration with existing endoscopic video towers.
   
   
   • Ability to display navigation overlays on primary OR monitors.
   
   
   • Support for sterile field interaction (e.g., pointer-driven controls, workflow steps).
   
   
   
   


6. Software Features
   
   
   
   • Preoperative planning tools.
   
   
   • Anatomical mapping and sinus cavity segmentation.
   
   
   • Accuracy check function with real-time updates.
   
   
   • User profiles, case saving, and documentation tools.
   
   
   
   


7. Hardware Requirements
   
   
   
   • Mobile cart or tower system with medical‑grade displays.
   
   
   • Tracking emitter/sensor mounts suitable for ENT surgical positioning.
   
   
   • Food and Drug Administration-cleared Class II medical device.
   
   
   
   


8. Specifications: Brand name or equal system shall include but not limited to the minimum:

• One (1) Navigation System Main Console


• One (1) Tracking System (Electromagnetic Tracking System or optical)


• One (1) Navigation‑ready medical‑grade display (24–32 inches)


• Instrument tracking coils or reflectors as applicable


• Navigation-enabled ENT surgical instruments or adapters


• Sterile drapes for navigation sensors and instruments


• All required cabling, power cords, and integration accessories


• Pre-validated software version with all ENT modules licensed


• Compliance with Food and Drug Administration 21 Code of Federal Regulations 820 Quality System Regulation


• Compliance with Veterans Administration cybersecurity and interconnection requirements (Memorandum of Understanding – Interconnection Security Agreement) If applicable