Attachment A - Salient Characteristics - Endoscope.docx

Salient Characteristics EndoFlip 300

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.

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.

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.

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.

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.

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.

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).

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.

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.