Exhibit 1-PWS.docx

Performance Work Statement: EnSite X Electrophysiology Mapping System Service Contract

Department of Defense Defense Health Agency Performance Work Statement

EnSite X Electrophysiology Mapping System Service Contract

04/01/2026

DMS

NMRTC Portsmouth

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide maintenance, repair, software support, and technical support for the EnSite X Electrophysiology Mapping System and associated components.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform EnSite X Electrophysiology Mapping System Service as defined in this Performance Work Statement (PWS).

1.1.2 Background: The Cardiac Cath Lab at Naval Medical Center Portsmouth, VA has a requirement for a maintenance and service plan for the EnSite X Electrophysiology Mapping System used in the diagnosis and treatment of cardiac arrhythmias.

1.1.3 Scope: Continuous system availability and functionality are essential to support patient care and procedural efficiency in the EP/Cath Lab. An annual service contract is required to support the EnSite X Electrophysiology Mapping System located within the Cardiac Cath Lab. Services include preventive maintenance, corrective maintenance, software updates and upgrades, technical support, and system optimization. The contractor shall ensure the system remains fully operational and compliant with Original Equipment Manufacturer (OEM) standards.

1.1.4 Period of Performance (PoP):

· Base Year: One (1) year from Effective Date

· Optional Year 1: One (1) year from expiration of Base Year

· Optional Year 2: One (1) year from expiration of Optional Year 1

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at Naval Medical Center Portsmouth, VA, 620 John Paul Jones Cir, Portsmouth, VA 23708, Building 2, Cardiac Cath Lab, Room 351502D.

Independence Day

1.2.3 Hours of operation: The contractor is responsible for conducting business Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.2.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

2.0 SPECIFIC TASKS

2.1 Preventive Maintenance: Contractor shall perform comprehensive preventive maintenance in accordance with OEM recommendations, including inspection, calibration, and system testing.

2.2 Repairs: Contractor shall provide all necessary corrective maintenance and on-site repair services. Response time shall be within one business day minimizing equipment downtime.

2.3 Replacement Parts: Contractor shall provide all necessary replacement parts, including shipping and installation, using only OEM-approved parts or equivalent, to maintain system functionality.

2.4 Software Updates and Upgrades: Contractor shall provide all software updates, upgrades, and expansion modules required to maintain and enhance system functionality, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

2.4.1 Copies of software license and software maintenance releases are to be sent to the NMCP IMD Office at NMCP

2.4.2 Supplied, software / license shall be provided free of all additional royalties or charges.

2.4.3 All supplied software must be certified free of damaging properties such as viruses, Trojan horses, worms etc.

2.4.4 NMCP recognizes that the use of all supplied software is for the sole use of NMCP. NMCP agrees not to share, sell, copy, lease or assign supplied software without the expressed permission of vendor.

2.4.5 NMCP shall make all attempts to preserve the proprietary nature of all supplied software. Vendor shall take all reasonable measures to safeguard all NMCP file data. (i.e. vendor shall not share any medical records / data collected by supplied software)

2.4.6 All technical support personnel must be adequately trained and knowledgeable of the software supplied.

2.4.7 Vendors price to be inclusive of all cost including labor, parts, travel, shipping and software license fees.

2.4.8 Support and maintain subscription services on software though the renewal period. This includes:

2.4.9 Setting up/maintaining individual user accounts,

2.4.10 Maintaining accounts for user/license management,

2.4.11 Trouble ticket submission if necessary, and

2.4.12 Serial number management.

2.4.13 If the required SW does not offer a subscription-based license, the vendor will provide the SW and any new software versions should they become available at the beginning of the next option period. If a SW company transitions from individual license purchase to subscription-based service during the renewal period, the vendor will provide, set up and manage the same number of subscriptions as initially purchased.

2.4.14 Equipment List: The required services shall cover the list of equipment in Table 1:

Table 1: Equipment List

ENSITE™ X EP SYSTEM:

ENSITE™ X AMPLIFIER

EnSite™ X EP System Field Frame.

EnSite™ X EP System SurfaceLink™ Module.

EnSite™ X EP System Catheter Input Modules.

EnSite™ X EP System Patient Reference Sensors.

EnSite™ X EP System ECG cable.

ENSITE™ X DISPLAY WORKSTATION (DWS)

EnSite™ X EP System Workstation.

Monitors.

Medical Grade Isolation Transformer.

ADAS 3D BASE MODULE

ENSITE™ VOXEL FLEX MODE

ENSITE™ VOXEL FLEX MODE

TACTIFLEX™ ABLATION CATHETER, SENSOR ENABLED™ SOFTWARE

TactiFlex™ Ablation Catheter

Sensor Enabled™ (model A-TFSE-D, A‑TFSE-DD, A‑TFSE-DF, A‑TFSE-F, A‑TFSE-FJ, A‑TFSE‑J, A‑TFSE‑JJ,A‑TFSE‑FF)

TactiSys™ Quartz Equipment (PN-004 400)

Compatible ablation generator

ENSITE™ LIVEVIEW DYNAMIC DISPLAY

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (model DAVHD-

DF16)

Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (model DAVHDX-

DF16)

2.4.15 On-Site Maintenance: Includes all airfare, lodging, car rental, food, labor, and travel expenses. On-site maintenance is extended for equipment, on-site inspection and maintenance which shall include system optimization and cleaning. Includes customization and configuration for all devices needed. Training for medical staff may include (but not limited to): All relevant equipment and software training. On-site training will be arranged in advance of scheduled on-site by appropriate parties of NMCP and the contractor.

2.4.16 Training Subscription Maintenance: Support and maintain user access to online training websites. This includes setting up/maintaining individual user accounts, maintaining accounts for user/license management and trouble ticket submission if necessary.

3.0 QUALIFICATIONS/CONSIDERATIONS

3.1 Special Qualifications/Considerations: The Contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the repair of all equipment listed in PWS Section 2.4.14. Certification of the OEM shall always be current (within two years) upon contract award, and throughout the contract period. The contractor and its employees shall maintain qualifications throughout entire contract period. If a sub-contractor is used for this requirement, the sub-contractor must be a certified agent of the OEM. Qualification includes but is not limited to the certification of all repair personnel and repair facilities by the OEM as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally, the contractor must have ready access to parts inventory of OEM replacement parts. All services, software, and parts must be OEM-approved to ensure compatibility, warranty compliance, and system performance.

4.0 DELIVERABLES

4.1 Deliverable 1-Kickoff Meeting: The contractor will set up a kickoff meeting within ten (10) business days of award, providing the necessary materials (i.e. slide decks, documents, etc.) to review the performance and communication plan needed to accomplish the full lifecycle of service described in the PWS and Request for Quotations (RFQ).

4.2 Deliverable 2-Quarterly Reports: Quarterly reports, as a contract deliverable, provide a periodic summary of progress, performance against the scope outlined in the PWS and RFQ, and any significant issues or risks encountered during the preceding quarter. The report provides a transparent view of maintenance status for equipment and software, budget adherence, invoice status, training, and quality control measures. The report outlines planned activities for the upcoming quarter, incorporating any necessary adjustments based on the prior quarter's performance. The report will include a summary of current invoice status and projected invoice submissions for the succeeding quarter. The report serves as a formal communication channel for monitoring contract compliance, facilitating proactive decision-making, and ensuring alignment between stakeholders.

5.0 PERFORMANCE REQUIREMENTS SUMMARY MATRIX EXAMPLE

5.1 Quality Assurance:

5.1.1 Quality Assurance Surveillance Plan: The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight detailed in the performance summary matrix and included in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

5.1.2 Documenting Contractor Performance Assessments:

Each performance assessment activity should be documented as it is conducted. This documentation constitutes an official record and may be considered past performance information. The people assessing performance should use a checklist to record their observations of the contractor’s performance. ALL performance should be documented whether it is acceptable or unacceptable in accordance with the performance assessment plan.

5.1.3 Performance Requirements Summary Matrix: By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

Table 4: Performance Requirements Summary Matrix

Software Subscription Maintenance: PWS Section 2.4

Quarterly Report All software user accounts are current, trouble tickets are answered within 24 hrs., and serial numbers are 100% recorded and accurate.

100% Compliance

Direct Observation, Service Report

Past Performance

Maintenance for Equipment:

PWS Section 2.1, 2.2, and 2.3

Deliverable 1: Kickoff Meeting Section 4.1

Deliverable 2: Quarterly Reports Section 4.2

6.0 POINTS OF CONTACT

6.1 Points of Contact:

End User POC: To be completed at award Email: To be completed at award Phone: Office To be completed at award

Contracting Officer Representative (COR): To be completed at award Email: To be completed at award Phone: To be completed at award

Contracting Officer: Matthew Teel Email: matthew.d.teel.civ@health.mil Phone: To be completed at award image1.png