Attachment B - Statement of Work.docx

STATEMENT OF WORK/PERFORMANCE WORK STANDARDS

IMPEDANCE PLANIMETRY SYSTEM

A. GENERAL OBJECTIVES AND REQUIREMENTS:

1. Title of Project: Impedance Planimetry System

2. Authority for the project: Direct replacement of worn/end of life equipment no longer supported by the manufacturer.

3. Purpose of the project: Purchase direct replacement of the Impedance Planimetry System for Gastroenterology

4. Background: Our current Endoflip 100 system is nearing end of use and displaying signs of internal electronic failure. Specifically, the system is no longer consistently recognizing disposable EndoFlip catheters during connection and calibration. There are many types of motility disorders, and pinpointing the underlying cause of the patient’s symptoms can be challenging in our Veteran population.

5. Scope and methodology: Purchase, deliver and install the Impedance Planimetry System as applicable.

B. SALIENT CHARACTERISTICS

1. FDA approved indications for use:

· For use in the clinical setting to measure pressures and dimensions in the esophagus, stomach, and anus. The system is intended as an adjunctive diagnostic test in patients with GI motility disorders.

· For use to estimate the size of a gastric band stoma during placement.

· For use as an adjunct to a bougie during the bariatric surgical procedure, a laparoscopic sleeve gastrectomy. It is suitable for sleeve gastrectomy operations performed with 22 to 60F bougies.

2. Clinical function and use:

· System must measure and display intraluminal dimensions and pressure to assess distensibility and compliance of the esophagus, pylorus, and anal sphincters in adult patients, and at minimum esophageal measurements in pediatric patients ≥5 years of age, when used as an adjunct to other diagnostic methods for GI motility disorders.

· System must provide real‑time impedance planimetry–based estimates of luminal diameter and cross‑sectional area at multiple points along a compliant balloon catheter during endoscopy.

· System must allow controlled inflation and deflation of a connected balloon catheter to user‑selected volumes and rates suitable for esophageal and sphincter assessment without manual syringe operation.

3. Must have display measurement capabilities:

· System must continuously display estimated balloon diameter at multiple axial positions (multi‑segment measurement) with numerical and graphical output suitable for clinical interpretation by a trained endoscopist.

· System must display balloon pressure, balloon volume, and calculated distensibility/compliance values when used with compatible pressure‑sensing catheters. System shall provide real‑time “topography‑style” visualization of luminal geometry or distensibility over the measurement length to support motility and outlet evaluation.

4. Must be capable of data capture and study management:

· System must support entry and storage of basic patient and study identifiers (patient ID, name, date of birth, gender, indication, physician, and institution) for each procedure.

· System must allow saving of still images or data snapshots that include time stamp, balloon volume, and balloon pressure values at the time of capture.

· System must support continuous recording of procedure data for a minimum of several hours (≥6 hours) to cover typical diagnostic and intra‑procedural monitoring needs.

5. System configuration and components must include:

· System must include a pump/drive unit capable of automated syringe movement for inflation/deflation of single‑use balloon catheters designed for impedance planimetry.

· System must include an integrated or dedicated display unit large enough to clearly show numeric data and topography plots for use in a procedure room environment.

· System must include a mobile cart or be compatible with a medical‑grade cart suitable for procedure room use, with cable management and space for the pump and display components.

6. Physical and environmental requirements:

· Pump and display components must be of manageable size and weight for placement on a standard procedure‑room cart or mounting system (approximate size in the range of a small bench top medical device, not a floor‑standing gantry).

· System must operate under typical procedure‑room conditions, at minimum within an ambient temperature range of approximately 20–40 °C and relative humidity 15–95% non‑condensing.

· System must be suitable for transport and storage over a broader temperature range (approximately −30–60 °C) to accommodate hospital logistics and storage areas.

7. Electrical, safety, and EMC:

· System must operate on standard hospital AC mains power with wide‑range input (approximately 100–240 VAC, 50/60 Hz) without the need for external transformers.

· System must meet medical electrical safety and electromagnetic compatibility requirements applicable to professional healthcare environments (e.g., compliance with IEC/EN 60601‑1‑2 Class A emissions and immunity suitable for use in hospitals).

· System must include audible and visual alarm capability for clinically relevant system conditions (e.g., pressure limits, system errors), with audio alarm sound level sufficient for a typical procedure room.

8. Performance and essential safety behavior:

· System must provide reliable operation without unintended motor movement of the syringe drive and shall support user‑initiated inflate, deflate, and stop commands that respond promptly at the intended rate. In the presence of electromagnetic interference, the system must be designed so that abnormal or artifact values are identifiable and do not result in unsafe autonomous operation (e.g., no uncontrolled inflation).

9. Workflow and compatibility:

· System must be compatible with single‑use balloon catheters specifically designed for impedance planimetry and esophageal/sphincter assessment and be able to recognize or configure catheter‑specific measurement lengths and ranges.

· System must be intended for use in an endoscopy or GI procedure suite and integrate into standard endoscopic workflow, allowing measurements during upper endoscopy without requiring a separate invasive procedure.

10. Infection control and maintenance (high‑level):

· System design must support routine cleaning and disinfection of external surfaces using standard hospital disinfectants per manufacturer instructions for use (IFU).

· Patient‑contact components for intraluminal use (balloon catheters, syringes) must be single‑use only and intended for disposal after one patient use.

C. TASKS AND ASSOCIATED DELIVERABLES

1. Description of tasks and associated deliverables

i. For the Impedance Planimetry System, the vendor shall provide user manuals that describe proper use, care and cleaning for users of the equipment. In addition, the vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

ii. Impedance Planimetry System must be current generation system which is supported by the manufacturer and not obsolete. The equipment must not be used or refurbished. As applicable, the laser must have the latest manufacturer’s software/hardware updates installed and if applicable, any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

2. The following Address is applicable

i. Delivery location: Department of Veterans Affairs VA Medical Center-San Diego (Warehouse) 3350 La Jolla Village Dr. San Diego, CA 92161

ii. Warehouse contact for drivers to make a 1 hour pre-call prior to delivery. Isaac 858-642-3465, or Hugh 858-642-2470 Warehouse Leader

iii. Installation – Jennifer Moreno VA Medical Center, 3350 La Jolla Village Drive San Diego, CA 92161

3. The required delivery window is no earlier than February 28, 2026 and no later than September 30, 2026. The awardees actual delivery dates will be confirmed by VA upon award.

4. Post-award, the vendor will coordinate delivery identified in this document with the VAMCSD prior to beginning any work. Once the dates have been confirmed, modifications to the schedule are subject to written approval by the CO, and the vendor. Schedule changes that are beyond the dates specified in the contract will require approval by the Contracting Officer and a contract modification.

5. Delivery and receipt of the proposed items is anticipated to be directed to the location identified in C.2.i. above. Confirmation of delivery location will be provided post-award. To coordinate delivery, contact VAMCSD POC Isaac Fernandez 858-642-3465, or Hugh 858-642-2470 Warehouse Leader. The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

6. The delivery of items identified in this document shall be pre-coordinated 72 hours in advance with the POCs and take place during normal business hours which are defined as:

8:00 AM to 3:00 PM Pacific Daylight Time, Monday through Friday, and excluding Federal Holidays.

7. Labeling of delivered items shall include the VA facilities contract number and VA purchase order number for identification and reference upon receipt of product.

8. There are no dumpsters available for vendor use. The removal of waste is the responsibility of the Vendor.

9. Assembly and installation are also required.

10. On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 8:00 AM to 4:00 PM Pacific Daylight Time, Monday through Friday, and excluding Federal Holidays.

11. The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

12. The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

13. The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor’s (or associated sub-contractors) installation.

14. During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and VAMCSD. On-site representative can be the installer. All instructions provided from VAMCSD POCs in C.5. above to the representative will be binding as if given to the vendor’s main contact. The VAMCDS may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.