ATTACHMENT A_ STATEMENT OF WORK.pdf

Statement of Work (SOW) Workload Expansion Equipment for Existing Stryker Surgical Endoscopy Systems

Brand‑Name‑or‑Equal Requirement (BN/OE) Quantity: 2 each (per CLIN as noted)

Agency: U.S. Department of Veterans Affairs (VA) Facility: VAMC Fayetteville, AR. Station #564, 1100 N. College Ave. Fayetteville AR. 72703

1. Background / Purpose

The Department of Veterans Affairs (VA) requires additional surgical video and arthroscopy equipment to expand clinical workload capacity within existing Stryker endoscopic imaging platforms. The requested equipment shall be brand‑name‑or‑equal to the Stryker‑listed components and fully compatible with the facility’s deployed Stryker 1688 AIM systems.

The equipment will support arthroscopy, minimally invasive surgery, and sterile processing workflows using OEM-approved accessories and trays

2. Scope

The Contractor shall provide the listed OEM‑new, unused, fully warranted endoscopic imaging components, accessories, scopes, and sterilization trays that are functionally and mechanically compatible with current Stryker 1688 AIM imaging platforms. The Contractor shall provide inside delivery, installation/setup (non-networked), functional verification, operator orientation, documentation, and warranty support. All equipment shall meet all manufacturer IFU, FDA, electrical safety, and VA Biomedical Engineering requirements.

3. Brand‑Name‑or‑Equal Requirement

This acquisition identifies certain Stryker part numbers to define the required performance, form, fit, compatibility, and quality level needed for use with the VA's existing systems.

Under FAR 11.104, products offered as “equal” must meet or exceed all of the following:

3.1 Mandatory Objective Compatibility Requirements

Any offered equal item must:

• Maintain full operational compatibility with Stryker 1688 AIM imaging systems without adapters beyond those listed.

• Fit Stryker camera couplers, arthroscopes, and sterile processing trays as currently deployed.

• Support 4K UHD imaging with equal or greater optical clarity and signal performance.

• Support VA sterile processing (SPD) workflow, including steam sterilization parameters per manufacturer IFU.

• Be FDA-cleared for the same intended surgical uses.

• Have equivalent or superior durability, warranty, and safety standards.

Failure to demonstrate compliance will render the product unacceptable.

4. Bill of Materials (BN/OE) - All items below require a quantity of 2 each.

A. 4K Camera Head with Integrated Coupler (BN/OE to Stryker 1688610122) Performance requirements:

• Must deliver 4K UHD video output

• Must integrate directly with Stryker 1688 AIM console

• Must support standard arthroscopy optics

B. Fiber Optic Illumination Cable, 5 mm (BN/OE to Stryker 0233050400) Requirements:

• Minimum 5 mm diameter

• High-intensity, autoclavable

C. Scope Adapter (Henke/Dyonics/Storz compatible) (BN/OE to Stryker 0233050087) D. Camera Sterilization Tray (BN/OE to Stryker 0233410002) Requirements:

• Rigid metal design

• SPD-validated for steam cycles

E. 4K Eyepiece Arthroscope, 4 mm × 30° (BN/OE to Stryker 0502444030) Requirements:

• 4 mm diameter

• 30° angled view

• Autoclavable

F. Pump Cannula, 5.8 mm with Rotating Stopcocks (BN/OE to Stryker 0747031550) G. Pencil Obturator, 5.8 mm (BN/OE to Stryker 0747031510) H. Endoscope & Hardware Set Tray (BN/OE to Stryker 0233032116)

5. Contractor Responsibilities

The Contractor shall:

• Deliver OEM-new devices in sealed packaging

• Set up and perform non-networked installation

• Conduct functional verification with VA Biomedical Engineering

• Provide operator orientation and training for clinical and SPD staff

• Provide all documentation, IFUs, and warranty materials

• Ensure proposed equal items include full technical comparison sheets

6. VA Responsibilities

• Provide access to existing Stryker imaging equipment for compatibility verification

• Provide scheduling for staff orientation

• Complete final acceptance upon successful testing

7. Performance & Acceptance Criteria

Acceptance is based on the following measurable criteria:

• All delivered items match the BN/OE specifications in Section 3 and 4

• All equipment demonstrates full compatibility with Stryker 1688 AIM during functional testing

• All items pass Biomedical Engineering inspection

• All SPD trays confirm correct fit, labeling, and sterilization compliance

• All IFUs match FDA-cleared uses and sterilization parameters

• Delivery of all documentation and proof of warranty.

• Contract completed after acceptance, documentation delivery, and invoice approval.

• Biomed verifies functionality, documentation, sterilization compliance, UDI tagging, and training completion.

8. Place of Performance

Delivery to: VAMC Fayetteville, AR., 1100 N. College Ave., Fayetteville, AR 72703

9. Delivery Schedule

Delivery within 30–60 days ARO, unless otherwise approved by the Contracting Officer.

Period of performance (POP) shall be from award through installation and final acceptance.

10. Warranty

Minimum 12-month OEM warranty covering defects in materials and workmanship.

11. Training Requirements

Contractor shall provide operator orientation on:

• Device operation

• SPD cleaning and sterilization workflow

• Safety and handling

• Basic maintenance

12. Safety, Compliance & Standards

All equipment must comply with:

• FDA regulations for Class II medical devices

• AAMI, ANSI, UL, IEC, and NFPA 99 standards

• Manufacturer IFUs

• VA Biomedical Engineering policies

• HIPAA/Privacy Act (non-networked devices)

13. Invoicing Invoices shall be submitted via IPP/Tungsten per standard VA procedures.

14. Deliverables

• All equipment listed in BOM

• Manuals, IFUs, warranty

• Installation assistance and functional testing

• Operator orientation

• Acceptance documents

15. Government-Furnished Equipment

Existing Stryker systems are available for compatibility verification.

16. Security, Privacy, and Records Management

Devices are non-networked; contractor shall comply with HIPAA, Privacy Act, NARA, and VA 6300 policies. Contract/Contractor will not be creating, using, storing or dispositioning federal records.

17. Packaging, Shipping, and Damage

OEM-sealed packaging; replacements required if damaged.

18. Constraints & Assumptions

No substitutions without approval; no clinical disruption; contractor shall follow VA safety policy.

19. Risk Management

Compatibility verification required; sterilization workflow validated; issues corrected before use.