ATTACHMENT B SOW GI impedance planimetry system.docx

Statement of Work (SOW) Impedance Planimetry System

1. BACKGROUND

Department of Veterans Affairs, VISN 22, VA Loma Linda Healthcare System (VALLHS) needs a new Impedance Planimetry System to replace the current system that has reached end of life status, and the manufacture will no longer provide service and support for the system. The Impedance Planimetry System is required by the Gastroenterology (GI) Service to support advanced gastrointestinal diagnostic and therapeutic procedures. This system provides real-time measurements of esophageal and pyloric distensibility, pressure, diameter, and motility during endoscopic procedures. These measurements assist GI providers in evaluating Veterans with complex conditions such as dysphagia, achalasia, esophageal motility disorders, gastroesophageal junction outflow obstruction, pyloric dysfunction, and other GI conditions requiring specialized assessment.

2. SALIENT CHARACTERISTICS

2.1. The EndoFlip 300’s 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.

2.2. 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.

2.3. 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.

2.4. 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.

2.5. 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.

2.6. 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.

2.7. 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).

2.8. 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.

2.9. 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.

2.10. Three Year Service Plan

· Equipment may be repaired or replaced (with functionally equivalent equipment) Customer’s Covered Equipment at no charge, including shipping, parts and labor.

· Provide Customer with functionally equivalent equipment while Customer’s Covered Equipment is being serviced or replaced.

· Software versions offered for commercial sale will be offered to Customer at no charge for the term of this Service Plan.

3. INSTALLATION:

· Delivery must be with ninety (90) days of ordering.

· Complete installation and go live must be completed within sixty (60) of delivery.

· The vendor shall ensure all equipment delivered is fully operational to manufacturer’s specification and free from defect.

· The vendor shall provide delivery, set up, and technical support for clinical staff and clinician training for use the system.

· The vendor shall report all recalls, removals, modifications and safety notices from the manufacturer, distributor and FDA, and provide immediate notices (within 48 hours) to the Contracting Officer and the facility point of contact and the VHA Product Recall Office for any notices identified for medical devices.

· The vendor shall coordinate with VA Supply Chain Management or facility appropriate contact agree upon delivery day and arrival to the facility.

· Must include operations manual.

· Must include a manufacturer warranty.

4. POINT OF CONTACT

Loma Linda, CA 92357

5. PLACE OF PERFORMANCE

VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357

6. PERIOD OF PERFORMANCE

Delivery to be within 60 days after award.

7. DELIVERY

Vendor will deliver the following items to:

VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357