DRAFT_SOW ULTASOUND SYSTEM_7.27.26.pdf

STATEMENT OF WORK

BRAND NAME OR EQUAL | Abbott ViewMate™ Multi Ultrasound System

1. Background

The VA Palo Alto Health Care System (VAPAHCS) Cardiac Catheterization and Electrophysiology Laboratory request the procurement of Brand Name, Abbott ViewMate™ Multi Ultrasound System. The system will be used to acquire intracardiac ultrasound (ICE) images during electrophysiology studies and ablations to identify anatomical sites and catheter position within the chambers of the heart. The ViewMate™ Multi Ultrasound System integrates exclusively with the Abbott EnSite X Mapping System currently installed at VAPAHCS and is compatible with the CPRC committee-approved ViewFlex™ ICE Catheter.

2. Scope of Work

The contractor, Abbott Laboratories Inc. (formerly St. Jude Medical), shall provide the following:

DRAFT SOW: BRAND NAME OR EQUAL

Item Part Number Qty

ViewMate™ Multi Ultrasound System VMM-ICE-02 1

ViewMate™ Multi Ultrasound System ICE Integration 2DSE-VMM 1

SP5-1s Phased Array Transducer SP5-1S 1

L9-3s Linear Array Transducer L9-3S 1

The contractor shall deliver, install, test, and provide initial training on the ViewMate™ Multi Ultrasound System at the work location identified in Section 4.

3. Requirements

3.1 Equipment Requirements

The ViewMate™ Multi Ultrasound System shall meet the following minimum specifications:

• Imaging Modes: 2D/B-Mode, M-Mode, Pulse Wave Doppler (PW), Continuous Wave Doppler (CW), Color Doppler, Power Doppler, and AUX CW

• Display: Minimum 23.5-inch high-resolution color LCD display mounted on articulating arm

• Touch Panel: Minimum 15.6-inch touchscreen with intuitive gesture controls

• ICE Capability: 4D Intracardiac Echo (ICE) capable, compatible with ViewFlex™ family of ICE catheters

• Mapping Integration: Must include communication interface to the Abbott EnSite X Mapping System via EnSite™ Echo Module license and cabling kit

• Battery: Rechargeable battery providing minimum 2 hours of operation without AC power

• Storage: Minimum 1 TB hard drive storage

• Transducer Ports: Capable of connecting up to 4 transducers simultaneously

• Connectivity: Integrated wireless, multifunction USB ports, HDMI/VGA digital video output

• DICOM: DICOM networking including Verify, Store, Print, and Basic Modality Worklist Query service classes

• Cybersecurity: AES-256 bit data encryption, TLS 1.2, Secure DICOM, anti-virus software, Role Based Access Controls (RBAC)

• Software: Pre-installed with ViewMate™ Multi Software V2.0 (VMM-SW-2.0)

• Mobility: Compact, collapsible roll-around cart with customized supply baskets

• ECG: 3-Lead ECG connection

3.2 ICE Integration Package Requirements

The ICE Integration package (2DSE-VMM) shall include:

• EnSite™ Echo Module license and cabling kit

• EnSite™ Remote Monitor

• EnSite™ Remote Cart Monitor Mount Bracket

• EnSite™ Dual Monitor License

• ViewFlex™ X ICE SE, EnSite™ X Connector Cable (Qty. 5)

3.3 Transducer Requirements

• SP5-1s Phased Array Transducer: Single crystal design, 1.5–4.5 MHz, for Adult Abdominal, Adult Cardiac, Adult Cranial, Pediatric and Cardiac applications

• L9-3s Linear Array Transducer: 2.5–9.0 MHz, for Abdominal, Pediatric, Small Organ, Musculoskeletal, Vascular and Nerve applications

4. Delivery

The contractor shall deliver all items listed in Section 2 to the work location identified in Section 4. Delivery shall be coordinated in advance with the Contracting Officer's Representative (COR). Delivery shall occur within a mutually agreed upon timeframe following receipt of the Government Purchase Order.

The contractor shall provide written confirmation of the scheduled delivery date no less than five (5) business days prior to delivery.

5. Installation

5.1 Contractor Responsibilities

Installation shall be performed by Abbott Laboratories Inc. certified clinical specialists at no additional charge, as included in the Capital Purchase Agreement (Document No.

116816.5). Installation shall include:

• Uncrating and assembly of all system components

• Placement of system in the desired location as directed by the COR

• Loading and configuration of ViewMate™ Multi Software V2.0 (VMM-SW-2.0) on the Abbott EnSite Workstation

• Connection and configuration of ICE Integration package to the existing EnSite X Mapping System

• Initial functional testing and verification of all system components

• Provision of a copy of the Installation Report to the COR upon completion

Installation shall be performed during normal business hours (8:00 AM – 5:00 PM, Monday through Friday, Local Time) unless otherwise coordinated with the COR. Total installation time is not expected to exceed two (2) business days.

5.2 Government Responsibilities

VAPAHCS shall, at its expense:

• Provide free and unobstructed access to the installation site

• Ensure the installation site is ready and available on the agreed upon installation date

• Provide safe and secure storage space for equipment prior to installation if needed

• Ensure all necessary electrical, network ports, and site preparation requirements are completed prior to delivery

• Ensure Biomedical Engineering is available during installation as needed

5. Training

The contractor shall provide initial on-site operational training to designated VAPAHCS clinical staff upon completion of installation. Training shall cover basic system operation, imaging modes, ICE integration with the EnSite X Mapping System, and routine maintenance procedures. Training shall be provided at no additional charge as part of the installation services.

6. Warranty

The contractor shall provide a minimum one (1) year manufacturer's warranty effective from the date of installation completion for all delivered equipment, including:

• ViewMate™ Multi Ultrasound System (VMM-ICE-02)

• SP5-1s Phased Array Transducer (SP5-1S)

• L9-3s Linear Array Transducer (L9-3S)

The warranty shall cover parts replacement and manufacturer defects. Any warranty service shall be performed by Abbott Laboratories Inc. or their authorized service partner, Zonare Medical, per the Abbott/St. Jude Medical Sole Service Provider letter dated February 13, 2026.

7. Performance Period

Delivery and installation shall be completed within the period of performance established in the resulting contract or purchase order. The equipment shall remain in service for the duration of its operational life at VAPAHCS.

8. Information Security

This acquisition has been reviewed in accordance with VA Handbook 6500.6. The following determinations have been made:

• The ViewMate™ Multi Ultrasound System is a stand-alone medical device that stores patient data locally

• The system is not connected to the VA network

• FITARA review is not required

• No Business Associate Agreement (BAA) is required as no VA sensitive or protected health information (PHI/PII) is transmitted or stored on contractor systems

• The C&A requirements do not apply and a Security Accreditation Package is not required

The contractor shall not connect the ViewMate™ Multi Ultrasound System to the VA network without prior written authorization from the VA Information Security Officer (ISO). All data stored on the system's hard drive is protected by AES-256 bit encryption in accordance with the system's built-in cybersecurity features.

9. Contractor Personnel

Installation and any subsequent warranty service shall be performed by Abbott Laboratories Inc. certified clinical specialists or their authorized service partner, Zonare Medical, per the Abbott/St. Jude Medical Sole Service Provider letter dated February 13, 2026. Contractor personnel shall comply with all applicable VA facility access requirements, including wearing visible identification while on VA premises.

10. Privacy Act and Information Security Compliance

The Contractor shall comply with the Privacy Act of 1974 (5 U.S.C. § 552a) and all VA regulations governing the collection, use, maintenance, and dissemination of personally identifiable information (PII) and protected health information (PHI). The Contractor shall not use or disclose VA patient information for any purpose other than performance of this contract. Any VA patient data incidentally encountered during installation, testing, training, or warranty service activities shall be treated as confidential and shall not be removed, copied, transmitted, or retained by the Contractor or any of its personnel. The Contractor shall immediately report any suspected or confirmed breach of VA sensitive information to the COR and the VA Information Security Officer (ISO).

11. Travel Requirements

The Contractor shall ensure that all necessary personnel — including certified clinical specialists, technicians, trainers, and any other relevant individuals — are available for on-site delivery, installation, setup, and training services at VAPAHCS. The Contractor is solely responsible for arranging and covering all travel costs required for their team members in support of this contract, including but not limited to transportation, lodging, and per diem. Travel costs shall be included in the contract price and shall not be billed separately to the Government. No travel will be required or anticipated for Federal employees, as all delivery, installation, and training activities will take place at the VA facility identified in Section 4.

12. Inspection and Acceptance Criteria

All delivered equipment and components shall be subject to inspection and acceptance in accordance with the following criteria:

• All delivered equipment and components shall be inspected to verify that they meet the specifications, technical requirements, and safety standards outlined in this Statement of Work.

• Equipment must be new, unused, free from defects, and accompanied by all required manufacturer documentation, certifications, and Instructions for Use

(IFU).

• Functional tests shall be conducted to confirm that all equipment operates as intended and is fully compatible with existing VAPAHCS systems and clinical workflows, including the Abbott EnSite X Mapping System.

• Quality and condition of packaging shall be reviewed upon delivery to ensure no shipping damage has occurred. Any damage identified at the time of delivery shall be reported immediately to the Contractor and the COR.

• Installation, setup, and operational verification shall be performed by Abbott Laboratories Inc. certified clinical specialists in coordination with VA Biomedical Engineering and clinical staff.

• Final acceptance will be contingent upon successful completion of inspection, installation, and functional verification, including confirmation that the ICE Integration package communicates correctly with the existing EnSite X Mapping System.

• The designated Cardiology Service Points of Contact (POCs) shall confirm in writing that all equipment has been fully received, is complete, and is functional.

This confirmation shall be provided via email notification to the VA SCS Warehouse team to initiate the final processing of the Receiving Report.

13. Contractor Conduct and On-Site Safety Protocols

All Contractor personnel shall maintain a professional, courteous, and respectful demeanor at all times while on VA premises. Interactions with VA staff, Veterans, and their family members must reflect the highest standards of professionalism, sensitivity, and respect appropriate to a healthcare environment.

13.1 On-Site Conduct and Safety Requirements

All Contractor personnel shall comply with all VA property and facility guidelines. All personnel entering the facility for delivery, installation, training, or service shall:

1. Wear a face mask if required by current VA health and safety protocols in effect at the time of visit.

2. Be screened by VA site staff prior to entry in accordance with current VA facility access requirements.

3. Wear a company-issued uniform or clearly visible identification badge that identifies them as vendor personnel at all times while on VA premises.

4. Follow all posted safety signage and instructions from VA staff throughout their time on site.

5. Restrict their activities to only those areas of the facility necessary for performance of this contract.

6. Comply with all applicable VA patient privacy and confidentiality requirements, including refraining from photographing, recording, or otherwise documenting any patient, patient information, or clinical areas without prior written authorization.

Any violations of conduct, safety, identification, or privacy protocols may result in immediate removal of the offending personnel from the site and may result in formal contract action.

14. Warehouse Receiving Schedule

All deliveries shall be coordinated in advance with the COR and shall be scheduled during the following receiving hours:

VAPAHCS Warehouse / Loading Dock Receiving Hours

Days Monday through Friday

Hours 7:00 AM – 2:30 PM PST

Closed All Federal Holidays

Warehouse Email V21PALSupplyChainMMWarehouse@va.gov

The Contractor shall provide advance written notice of the scheduled delivery date and estimated arrival time to the COR and the Warehouse email group no less than five (5) business days prior to delivery. Deliveries arriving outside of the above hours or without prior coordination will not be accepted.

15. Applicable Standards and Regulations

• FDA clearance: ViewMate™ Multi Ultrasound System VMM-ICE-01/02

• Instructions for Use (IFU) available at manuals.sjm.com or eifu.abbottvascular.com

• VA Handbook 6500.6 — Information Security

• VA Directive 6550 — Pre-Procurement Assessment for Medical Devices

• Privacy Act of 1974 (5 U.S.C. § 552a)

• FAR Part 12 — Acquisition of Commercial Products and Services

• FAR 25.103 — Exceptions to Buy American Act (Nonavailability)