DRAFT STATEMENT OF WORK.pdf
PDF 170 KB Posted
- Attached to
- 6515--PreSOL/Sources Sought Notice-Medtronic brand name or equal- ENT Surgical Navigation System
- Solicitation number
- 36C25626Q0675
About this file
This is a Draft Statement of Work for the Central Arkansas Veterans Health Care System (CAVHS) for procurement, delivery, installation, integration, validation, and training of an ENT (Ear, Nose, and Throat) Surgical Navigation System. The system must support Functional Endoscopic Sinus Surgery (FESS), rhinology procedures, and anterior skull-base surgical interventions. The solicitation specifies Medtronic brand name or equal system with six specific component items including an Emitter Axiem 3 Table Top, SW Kit Stealth S8 ENT, Bracket Support Arm CC, Clamp Emitter Holder, Arm Side Mount, and Case Axiem 3 Flat Emitter, each with designated product numbers and quantities of one each.
The system must meet minimum technical requirements including electromagnetic and/or optical tracking capability with accuracy suitable for ENT/skull-base procedures (≤2 mm typical), full DICOM compatibility for CT and MRI datasets, integration with existing endoscopic video towers, preoperative planning tools, and anatomical mapping capabilities. The hardware must include a navigation system main console, tracking system, medical-grade display (24-32 inches), instrument tracking coils or reflectors, navigation-enabled ENT surgical instruments or adapters, sterile drapes, cabling, and prevalidated software with all ENT modules licensed. The system must be FDA-cleared Class II and comply with FDA 21 CFR 820 Quality System Regulation and VA cybersecurity requirements. Delivery must be completed within 30 days after receipt of order (ARO) to 2200 Fort Roots Drive, North Little Rock, AR 72114, Building 182, between 8am-4pm EST Monday-Friday with lift gate service required. The contractor shall coordinate delivery with Biomedical Engineering and Surgery/OR, provide inside delivery, complete full installation and configuration including network connectivity and PACS integration, perform functional testing and calibration, and provide a post-installation report. Training must be provided at no charge by authorized contractor representatives to all surgeons and hospital staff who will utilize the system.
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Central Arkansas Veterans Health Care System
Ear, Nose, and Throat Navigation System
DRAFT STATEMENT OF WORK (SOW)
I. Scope: The Central Arkansas Veterans Health Care System (CAVHS) requires the procurement, delivery, installation, integration, validation, and training for a new ENT(Ear, Nose and Throat) Surgical Navigation System to support Functional Endoscopic Sinus
Surgery (FESS), rhinology procedures, and anterior skull‑base surgical interventions.
II. Medtronic brand name or equal ENT(Ear, Nose and Throat) Surgical Navigation System.
Description Product Number QTY Unit Issue
1 Emitter Axiem 3 Table Top 9733752 1 EA
2 SW Kit Stealth S8 ENT 9735736 1 EA
3 Bracket Support Arm CC 9735833 1 EA
4 Clamp Emitter Holder 9733469 1 EA
5 Arm Side Mount 97357702 1 EA
6 Case Axiem 3 Flat Emitter 9734890 1 EA
III. System Requirements include but not limited to: The Ear, Nose, and Throat Navigation
System shall meet the following minimum requirements:
1. Navigation Technology o Electromagnetic (EM) and/or optical tracking capability.
o Ability to track multiple surgical instruments simultaneously.
o Accuracy suitable for ENT/skull-base procedures (≤ 2 mm typical).
2. Imaging Compatibility o Full DICOM compatibility for CT and MRI datasets.
o Ability to import, display, and register patient imaging.
o Support for automatic, manual, and landmark-based registration.
3. OR Integration o Integration with existing endoscopic video towers.
o Ability to display navigation overlays on primary OR monitors.
o Support for sterile field interaction (e.g., pointer-driven controls, workflow steps).
4. Software Features o Preoperative planning tools.
o Anatomical mapping and sinus cavity segmentation.
o Accuracy check function with real-time updates.
o User profiles, case saving, and documentation tools.
5. Hardware Requirements o Mobile cart or tower system with medical-grade displays.
o Tracking emitter/sensor mounts suitable for ENT surgical positioning.
o FDA-cleared Class II medical device.
IV. Specifications: The system shall include, at minimum:
• One (1) Navigation System Main Console
• One (1) Tracking System (EM 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
• Prevalidated software version with all ENT modules licensed
• Compliance with FDA 21 CFR 820 Quality System Regulation
• Compliance with VA cybersecurity and interconnection requirements (MOU-ISA, if applicable)
V. Maintenance: The price of the product shall include installation, complete on-site product testing and run through. All site modifications and preparations are the Buyer's responsibility and are to be completed to OEM specifications, prior to the date of the installation.
VI. Training: Contractor shall provide all necessary training for the staff on the ENT Navigation
System. All surgeons and other hospital staff who will be utilizing the system should be trained by an authorized representative. Upon installation of the ENT Navigation System, contractor representative will schedule training for Trainees at customer's site for no charge on a mutually agreeable date and time.
VII. Delivery & Installation: Delivery will be completed within 30 days ARO
The Contractor shall:
1. Coordinate delivery with Biomedical Engineering and Surgery/OR.
2. Provide inside delivery to the designated OR or storage area.
3. Complete full installation, configuration, network connectivity, and PACS integration
(if applicable).
4. Perform functional testing, calibration, and validation to ensure compliance with system specifications.
5. Provide a post-installation report documenting system readiness, testing results, and training completion.
6. Ensure removal and disposal of all packaging materials.
All contractor personnel entering VA property must comply with facility access, badging, cybersecurity, and infection control procedures.
1.Deliveries will be made to the loading dock at, Address: 2200 Fort Roots Drive
North Little Rock, AR 72114
Building 182
All items will be turned over to the Receiving/Warehouse staff
Delivery between the hours of 8am -4pm EST Monday-Friday
No deliveries on any Federal Holidays
A lift gate will also be required for all deliveries
Deliver equipment 30 days after purchase
2.Installation to be coordinated by POC
Tyler Jacobs, Surgery Business Manager
501-257-6816
Megan Doyle Administrative Assistant
501-257-6807
Barry Williams Inventory Management Specialist
501-257-4531
Betsi Mergenschroer Inventory Management Specialist
501-257-4538
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