Statement of Work.docx

STATEMENT OF WORK (SOW)

VA Palo Alto Health Care System Aesculap KAIRISON Pneumatic Bone Punch System

1.0 PURPOSE

The purpose of this procurement is to request to acquire one (1) Aesculap KAIRISON pneumatic bone punch system, including pneumatic handles, detachable shafts, pressure reducers, air hoses, storage baskets, container components, and accessories, for use at VA Palo Alto Health Care System (VAPAHCS). The system is required to support neurosurgical procedures, including spinal decompressions, by providing an efficient, pneumatically powered Kerrison‑type bone punch to remove bone, cartilage, and tissue while reducing surgeon fatigue and maintaining decompression quality.

2.0 SCOPE OF WORK

The Contractor shall furnish one (1) complete KAIRISON pneumatic bone punch system, including all labor, supervision, tools, materials, transportation, delivery coordination, setup, operational verification, training, and documentation required to deliver and prepare the system for clinical use at VAPAHCS. The scope includes KAIRISON pneumatic punch handles, pressure reducers, detachable shafts in multiple sizes and lengths, compressed‑air hose and fittings, wire baskets, sterilization container components, single‑use tube set, and maintenance oil spray as identified in the awarded vendor quotation.

3.0 DELIVERABLES

The Contractor shall furnish the following:

· Two (2) KAIRISON Pneumatic Punch Handles, Part Number FK899R

· Two (2) KAIRISON Pneumatic Punch Pressure Reducers, Part Number FK898R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 2 mm, Part Number FK882R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 3 mm, Part Number FK883R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 4 mm, Part Number FK884R

· Two (2) KAIRISON Shaft Detachable Up 235 mm x 5 mm, Part Number FK885R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 2 mm, Part Number FK892R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 3 mm, Part Number FK893R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 4 mm, Part Number FK894R

· Two (2) KAIRISON Shaft Detachable Up 285 mm x 5 mm, Part Number FK895R

· Two (2) Air Hose 5.0 m, Schrader / Aesculap large, Part Number GA468R

· Two (2) STERILIT Power Systems Oil Spray, 6 per carton, Part Number GB600

· Two (2) KAIRISON Wire Basket, Part Number FK881R

· Two (2) Wire Basket for KAIRISON Shafts, Part Number FK891R

· Four (4) Copper Cap for Compressed Air Supply, Part Number FK898214

· Four (4) Sealing Cap with Vent, Part Number FK898215

· Two (2) 3/4‑size Container Bottom 120 mm, Part Number JK741

· Two (2) 3/4‑size Lid with Retention Plate, Silver, Part Number JK789

· One (1) KAIRISON Disposable Tube Set, Part Number FK888SU

4.0 PERIOD OF PERFORMANCE

The period of performance begins upon award and continues through equipment delivery, installation, training, and acceptance. Expected completion is within 30 calendar days after receipt of order (ARO), subject to the manufacturer’s stated lead time.

5.0 ROLES AND RESPONSIBILITIES

· Contractor: Delivery, setup and assembly of the KAIRISON system, operational verification with compressed air, basic user training, documentation, and warranty support.

· Contracting Officer’s Representative (COR): Oversight, scheduling, and acceptance verification.

· Biomedical Engineering: Equipment inspection, incoming safety testing as applicable, verification of compatibility with existing compressed‑air infrastructure, and technical approval.

· Clinical Service (Neurosurgery / OR): Confirm workflow requirements, identify end users, and coordinate training schedules.

6.0 ACCEPTANCE CRITERIA

Final acceptance requires:

· Delivery of all items in new, unused condition that match the awarded quotation and meet salient characteristics.

· Successful Biomedical Engineering inspection and any required safety checks.

· Successful operational verification of the KAIRISON pneumatic bone punch with compressed air, demonstrating proper function of handles, shafts, and safety features (safety switch, locking slider, trigger action, and bone ejection).

· Completion of user training for designated neurosurgical and operating room staff (basic operation, safety, and care/handling).

· Receipt of all required documentation (instructions for use, technical specifications, warranty certificates, and any installation/verification reports).

7.0 POINT OF CONTACT (POC)

ADMINISTRATIVE POC:

Service: Surgical Service Facility: VA Palo Alto Health Care System (VAPAHCS) Email:

CLINICAL POC:

Service: OR Clinical Resources Nurse Facility: VA Palo Alto Health Care System (VAPAHCS) Email:

8.0 EQUIPMENT DESCRIPTION

The equipment shall be new and unused and shall consist of an Aesculap KAIRISON pneumatic bone punch system including pneumatic handles, detachable shafts in multiple sizes, pressure reducers, compressed‑air hose, storage baskets, container components, single‑use tube set, and maintenance oil. The system shall provide a pneumatically powered Kerrison‑type bone punch for removal of bone, cartilage, and tissue in neurosurgical procedures, particularly spinal decompression surgeries, in order to maintain procedural efficiency and reduce surgeon fatigue.

9.0 PERFORMANCE REQUIREMENTS

The system shall:

· Operate using compressed air or compressed nitrogen via manufacturer‑approved connectors, with nominal operating pressure approximately 8 bar and minimum operating pressure of at least 7 bar to ensure full cutting performance.

· Provide controlled, repeatable punching of bone and tissue via the KAIRISON pneumatic punch handle, with a two‑step actuation (positioning and punching) or single‑step punch using the trigger/actuator lever, and an integrated bone ejector mechanism in the shaft.

· Include detachable shafts in 2–5 mm diameters and 235 mm / 285 mm lengths to accommodate various neurosurgical approaches and working depths.

· Incorporate safety features including a safety switch to lock the trigger, shaft locking mechanism, and shaft release/locking slider as described in the manufacturer instructions for use.

· Be suitable for operating room use and meet all manufacturer operational, mechanical, and safety requirements, including sterilization and reprocessing requirements for reusable components and single‑use labeling for the disposable tube set.

· Include all accessories necessary for full functionality as intended in the manufacturer’s user manual and technical specifications.

10.0 DELIVERY AND RECEIVING

Contractors must communicate deliveries and provide 120 hours’ advance notice of any changes.

All deliveries, shipments, and vendor packages shall be made to the Supply Chain Services Warehouse, building 50, Palo Alto Division (PAD), 3801 Miranda Avenue, Palo Alto, CA 94304, unless otherwise directed. The contractor shall provide an estimated delivery date/time and tracking information prior to shipment.

Contractors using their own logistics personnel must review the VAPAHCS campus map to ensure delivery to the correct division. Coordination and communication shall include the Contracting Officer (CO), the requesting Service point of contact(s), and the Warehouse team email.

Delivery shall occur during normal dock business hours:

7:30 AM to 2:30 PM Pacific Time, Monday through Friday, excluding Federal Holidays.

Warehouse main line: 650-493-5000, extension 65300.

The final installation shall occur in Building 100 Operating Room.

11.0 DOCUMENTATION AND SUBMITTALS

The Contractor shall provide:

· Manufacturer instructions for use (IFU) for the KAIRISON pneumatic bone punch, shafts, pressure reducers, and accessories.

· Technical specifications, including operating pressure, materials, and reprocessing instructions.

· Warranty documents and service contact information.

· A brief functional verification/installation report summarizing setup and operational checks.

12.0 COMPLIANCE REQUIREMENTS

The Contractor shall comply with all applicable federal regulations, FDA requirements, VA safety protocols, infection control standards, and manufacturer installation and reprocessing standards for surgical instruments and pneumatic systems.

13.0 SERVICES

The Contractor shall:

· Deliver the KAIRISON system and all listed components.

· Perform initial setup and assembly, including connection to facility compressed‑air outlets where applicable.

· Provide basic user training for clinical staff on safe operation and care of the KAIRISON system.

· Remove and dispose of all shipping and packing materials from VA premises

14.0 WARRANTY

A minimum 12‑month manufacturer warranty covering parts and labor for the KAIRISON pneumatic bone punch system is required. Any additional warranty coverage offered in the vendor quotation shall be clearly documented and honored, including terms for repair or replacement of defective components.

15.0 HOURS OF OPERATION

Normal business hours: 0730–1630, Monday–Friday, excluding Federal Holidays.

16.0 PROTECTION OF PROPERTY

The Contractor shall protect VA property and repair any damage caused during delivery or installation.

17.0 SECURITY REQUIREMENTS

Contractor personnel shall comply with VA security and identification requirements. The equipment does not connect to VA networks; no cybersecurity documentation is required.

18.0 VA (REQUESTOR’S) RESPONSIBILITIES

· Provide access to delivery and installation areas.

· Coordinate escorting of Contractor personnel if required.

· Ensure availability of appropriate compressed‑air and electrical infrastructure in the installation area.

· Provide final acceptance through VA Biomedical Engineering Services and the requesting clinical service

19.0 GOVERNMENT-FURNISHED PROPERTY (GFP)

No Government‑Furnished Property will be provided to the contractor.

Based upon a review of the PWS/SOW and Appendix A as presented, the contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required. Please contact the V21PALPrivacyoffice@va.gov with any questions.

(END of SOW) VA Palo Alto Health Care System Aesculap KAIRISON Pneumatic Bone Punch System