Description

Medtronic brand name or equal equipment. Medtronic part numbers are reference only and that equivalency is determined solely by salients. 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. System Requirements : Brand name or equal ENT Navigation System shall meet the following minimum requirements: 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). 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. 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). 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. 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. 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

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• Attachment 1