P09 SOW 26AP2533 07.23.26.docx

STATEMENT OF WORK (SOW)

As of January 30, 2026

1. Contracting Officer’s Representative (COR).

2. Contract Title. The VASCULAB GSXB Non-Invasive Vascular Diagnosis System for end-of-life equipment replacement package FY26.

3. Background.

The VANEOHS Vascular Clinic is replacing their existing fleet of Vascular Non-Invasive Diagnostic Machines across all clinic locations. This Vascular Clinic equipment initiative requires seven (7) VascuLab GSX/VL4060-GSXB systems and all related equipment. This request for the listed equipment included in this SOW directly support this equipment initiative. This equipment is necessary to deliver high-quality eye care for the VANEOHS Veterans visiting all Vascular Clinic locations. Core equipment is essential for Vascular care and has a significant effect upon our ability to accurately evaluate and diagnose vascular patients, provide state-of the art technological expertise and allow for optimized efficiency and ergonomics for our Vascular clinics.

4. Scope.

The requested equipment is listed below by section and include required specifications/features:

1. Seven (7) VascuLab GSX/VL4060-GSXB (five (5) at East Blvd location, one (1) at Akron and one (1) at Youngstown.

2. Seven (7) DICOM: Modality Worklist (MWL) Storage (Store)/ (DICOM)

3. Seven (7) Techniques in Noninvasive Vascular Diagnosis, Encyclopedia (BOOK-TINVD500)

4. Seven (7) 19 CME Exam - Techniques in Noninvasive Vascular Diagnosis (BOOK-TINVD500CME)

5. Freight (1) Shipping Three (3) Chair, Full Power Dual Control CNTL – Charcoal (RE7000LCharcoal)

The VA Northeast Ohio Healthcare System is requesting purchase, delivery, installation, and configuration services for the listed equipment. The requested equipment shall be consistent with recent acquisitions of Vascular Non-Invasive Vascular Diagnosis Laboratory equipment within the Medical Center. This equipment (or equivalent) is being requested for consistency and performance as mentioned above.

The requested equipment solution shall provide, but not be limited to, the following functionalities/Capabilities:

1. Seven (7) VascuLab GSX/VL4060-GSXB

2. Seven (7) DICOM: Modality Worklist (MWL) Storage (Store)/ (DICOM)

3. Seven (7) Techniques in Noninvasive Vascular Diagnosis, Encyclopedia (BOOK-TINVD500)

4. Seven (7) 19 CME Exam - Techniques in Noninvasive Vascular Diagnosis (BOOK-TINVD500CME)

5. Freight (1) Shipping Three (3) Chair, Full Power Dual Control CNTL – Charcoal (RE7000LCharcoal)

· 12 VDC Battery Operation:

The system must operate fully on a 12 VDC battery, providing protection from power loss and AC line noise, and supporting operator convenience and true portability. Doppler testing is especially sensitive to AC line noise, so battery operation is essential to ensure reliable exam results and uninterrupted workflow.

· Post-Processing of Waveforms:

The equipment must enable post-processing of all physiologic waveforms (Doppler, PVR, PPG) and allow the application or change of filters both prior to and after acquisition. This ensures users can further optimize diagnostic data for accuracy after the initial study.

· Flexible Protocol Management:

The system must support the ability to change protocols on the fly during an existing study, maintaining continuous workflow without requiring a new study session. This maximizes efficiency and patient throughput.

· Toolless Unit Exchange & Loaner Support:

In the event of equipment repair, the system must allow for toolless exchange and be eligible for a loaner unit with prepaid return/shipping, so patient testing remains uninterrupted.

· Acceleration Time Measurement:

The equipment must be able to measure the acceleration time of all waveforms, a feature commonly used in clinical research.

· Dynamic Sample Rate:

System must support dynamic sample rates, providing granular (e.g., 1 mSec) resolution for detailed waveform analysis and acceleration time measurement.

· PPG Dynamic Gain and Noise Reduction:

The system must incorporate dynamic gain for PPG, delivering 10x sensitivity and enhanced signal quality while reducing backend noise.

· Digital Signal Processing (DSP) for Customized Filtering:

DSP capabilities must be available for real-time or post-processing customized data filtering.

· Dynamic FFT Adjustment:

The equipment must allow dynamic adjustment of the FFT (Fast Fourier Transform) bins to match user-selected Doppler scale.

· Spectral Doppler:

Equipment must support spectral Doppler imaging for comprehensive vascular diagnostics.

· System Self-Test:

A self-testing function must verify pump, valve, pressure sensor, and hose integrity with high accuracy prior to patient use.

· PPG Environmental Noise Testing:

Equipment must evaluate PPG for environmental noise (e.g., light interference), assuring reliable results in varied clinical conditions.

· Dedicated PVR Sensors:

PVR sensors should be scaled specifically for physiologic ranges (<70 mmHg), as opposed to generalized sensors (0–300 mmHg), to minimize signal noise.

· ABI Hose Configuration:

System must feature an optimized hose bundle specifically designed for ABI/Exercise tests, improving efficiency and ease of use for the most common procedures.

· Technology & Design: All-in-one medical-grade touchscreen computer with antimicrobial, washable keyboard and mouse pad.

· Imaging & Diagnostics: Spectral Doppler and high-sensitivity, ultra-stable PPG probes to minimize artifacts.

· Testing Capabilities: Combines air plethysmography (PVR), CW Doppler, and photoplethysmography (PPG) for ABI, TBI, and, segmental artery exams.

· Workflow Efficiency: 12-channel quick, quiet inflation, and, FDA-approved bayonet-style connectors.

· Portability & Battery: Optional 8-16 hour battery operation allows for, cordless operation for portability between rooms.

· Software & Connectivity: Intuitive, automated software with 24-function wireless remote, and, DICOM/network capabilities (WiFi or Ethernet).

Most importantly, battery-powered, cordless operation is a required characteristic. Our vascular testing equipment must be able to perform a complete range of physiologic and diagnostic tests entirely on battery power, with no cords needed during patient exams. This is crucial in our busy and crowded clinical environment, where cords can create hazards for staff and patients, limit mobility, and slow down our workflow. Portable, cordless operation allows us to move freely between patient rooms and bedsides, ensures uninterrupted testing, maximizes safety, and supports efficient patient throughput.

Additional required features include:

· Medical-grade, antimicrobial touchscreen interface for infection control and ease of use.

· Multiple test modalities (air plethysmography/PVR, CW Doppler, PPG) for ABI, TBI, and segmental exams, ensuring comprehensive vascular assessment.

· Quick-inflate, multi-channel cuffs and FDA-approved bayonet-style connectors for efficient setup and patient comfort.

· Intuitive, automated software with wireless remote and DICOM/network connectivity for seamless electronic documentation.

· Ability to post-process waveforms and test data after acquisition, enabling quick bedside studies and further optimization later for diagnostic accuracy.

5. Specific Tasks.

The requested equipment solution shall provide the above-mentioned equipment in accordance with the listed salient characteristics provided under the scope to meet the requirement in full. The contractor is responsible for providing the delivery, removal, and installation of all equipment and coordinate the shipment/delivery to the locations listed above within sufficient time to allow installation in each exam room. All installation services shall be provided through the original manufacturer of the requested equipment and shall be responsible for setup/installation by a fully trained/certified OEM representative. The requested services shall be performed in accordance with the OEM’s “premium white glove” delivery/install services. These services shall include, but may not be limited to, the following:

· A single point of contact for all project coordination

· Trained team from the OEM shall provide delivery and setup for all equipment and associated accessories.

· Delivery and setup service shall include delivery, uncrating, trash removal, product and accessory setup, and placement of units as needed.

· Manufacturer recommended operational test shall be performed and provide appropriate outcomes

5.1 Task 1 - Enterprise Management Controls.

5.1.1 Subtask 1 - Integration Management Control Planning. Acquisition of purchased goods and services only. The C&A requirements do not apply, and a Security Accreditation Package is not required.

5.1.2 Subtask 2 - Contract Management. DNA

Deliverables: Below is a total breakdown/ quantity to be delivered at Ravenna. Delivery, services are to be completed by the OEM of the new equipment, or their representative.

6. Seven (7) VascuLab GSX/VL4060-GSXB (five (5) at East Blvd location, one (1) at Akron and one (1) at Youngstown.

· Seven (7) DICOM: Modality Worklist (MWL) Storage (Store)/ (DICOM)

· Seven (7) Techniques in Noninvasive Vascular Diagnosis, Encyclopedia (BOOK-TINVD500)

· Seven (7) 19 CME Exam - Techniques in Noninvasive Vascular Diagnosis (BOOK-TINVD500CME)

· Freight (1) (Shipping)

Seven (7) VascuLab GSX/VL4060-GSXB)

Seven (7) DICOM: Modality Worklist (MWL) Storage (Store)/ (DICOM)

Seven (7) Techniques in Noninvasive Vascular Diagnosis, Encyclopedia (BOOK-TINVD500)

Seven (7) 19 CME Exam - Techniques in Noninvasive Vascular Diagnosis (BOOK-TINVD500CME)

Freight (1) (Shipping)

6. Performance Monitoring The COR and designated project manager, Kauzy Woods, Andrew Wampleman, or a designated proxy will mark off receiving report/packing materials once certifying that the purchased items have been delivered.

Clinical staff will certify/attest to the proper setup and installation of each equipment item and removal of corresponding equipment.

7. Security Requirements Does not apply

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Does not apply

9. Other Pertinent Information or Special Considerations.

Does not apply

a. Identification of Possible Follow-on Work.

Does not apply

b. Identification of Potential Conflicts of Interest (COI).

Does not apply

c. Identification of Non-Disclosure Requirements.

Does not apply

d. Packaging, Packing and Shipping Instructions.

Shipping to be directly to the Ravenna facility below in quantities specified:

e. Inspection and Acceptance Criteria.

The COR will verify proper and acceptable delivery, removal, installation, and any necessary configuration services and notify the Contracting Officer of any deficiencies.

10. Risk Control Does not apply

11. Place of Performance.

Delivery and installation services shall be completed by the OEM at the below locations and specified quantities:

Seven (7) VascuLab GSX/VL4060-GSXB)

Seven (7) DICOM: Modality Worklist (MWL) Storage (Store)/ (DICOM)

Seven (7) Techniques in Noninvasive Vascular Diagnosis, Encyclopedia (BOOK-TINVD500)

Seven (7) 19 CME Exam - Techniques in Noninvasive Vascular Diagnosis (BOOK-TINVD500CME)

Freight (1) (Shipping)

12. Period of Performance.

Equipment is expected to function as designed for a minimum of 5 years, with an expected life of 10 years

13. Delivery Schedule.