P09 Statement of Need Surgical Simulator.pdf

STATEMENT OF NEED

GENERAL: This Statement of Need (SON) defines the scope, deliverables, responsibilities, compliance requirements, and acceptance criteria for the procurement, installation, training, and sustainment of the HS Simulation Eyesi Surgical Complete System. The system will support ophthalmic surgical skills training for residents, fellows, and staff at James A. Haley

Veterans’ Hospital (JAHVH).

The objective is to enhance patient safety and strengthen competency‑based education by delivering a high‑fidelity, measurable, and repeatable surgical training environment.

BACKGROUND: JAHVH is expanding its ophthalmic surgical education program through advanced virtual-reality simulation with integrated haptic feedback and validated performance metrics. The Eyesi Surgical platform offers structured cataract and vitreoretinal training modules, realistic tissue interaction, authentic instrument handling, and standardized scoring.

This safe, reproducible training environment supports deliberate practice, objective assessment, remediation planning, and alignment with VA patient-safety initiatives and contemporary surgical-training standards.

PURPOSE: The Eyesi Surgical Complete System will be used as a teaching and skills-development tool to directly support improved patient care. Access to state-of-the-art ophthalmic simulation technology enhances early detection, clinical decision-making, operative proficiency, and ongoing competency in the management and treatment of eye diseases.

SCOPE: This is a name brand only requirement. The Contractor shall provide all labor, equipment, materials, licenses, installation, configuration, testing, training, documentation, and warranty/support services required to furnish a fully operational Eyesi Surgical Complete

System.

PHYSICAL CHARACTERISTICS: The simulator shall be a fully integrated, self-contained ophthalmic microsurgery workstation designed for realistic surgical training. Requirements include:

Overall Unit Construction & Design

• Ergonomic, compact simulator designed for seated operation, with a height-adjustable operating table to accommodate diverse trainee body types (based on published 60–860 mm operating table height range)

• Integrated surgical stereo microscope with adjustable arm, allowing realistic visualization and ocular alignment during simulated cataract and vitreoretinal procedures

• Stable, medical-grade frame with angled support feet and a lifting column for controlled vertical adjustment

• Approximate assembled dimensions consistent with manufacturer specifications (roughly 54 in height × 46 in width × 28 in depth)

• Total mass approximately 64 kg (excluding packaging), ensuring sufficient stability during high-precision instrument training while allowing mobility when needed

Integrated Components

• Touch-sensitive display for real-time performance feedback, menu navigation, and module selection

• Simulator PC enclosed in the main console, running vendor-provided VR surgical simulation software

• Instrument holder with modular cataract and vitreoretinal handpieces

• Dual-pedal system replicating surgical phaco and vitreoretinal foot-switch controls

• Surgical interface microscope head designed for realistic hand positioning, ocular alignment, and task accuracy

Electrical & Environmental Requirements

• Standard 00–230V AC, 50/60 Hz power input supporting varied facility infrastructure

• Typical operating temperature between 0–30°C and up to 80% non-condensing humidity, suitable for VA simulation rooms

Optional Components (When Applicable)

• Widefield optics for vitreoretinal surgery (BIOM/SDI compatible)

• Wrist rest for improved ergonomic support during microsurgical training

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: The Eyesi Surgical

Simulator shall provide a high‑fidelity, virtual‑reality ophthalmic microsurgical training environment with real‑time responsiveness, haptic fidelity, and performance analytics. The simulator must support both cataract and vitreoretinal training pathways when delivered in the

“Complete” configuration. Enhancements include:

1. Realistic Surgical Environment & Microscope Interaction

• High‑resolution stereoscopic visualization simulating depth, magnification, and ocular anatomy across cataract and vitreoretinal scenarios

• Realistic tissue behavior modeling, including capsular dynamics, lens interactions, retinal layers, membrane peeling, fluidics, and instrument‑tissue force relationships

2. Haptic & Instrument Fidelity

• Two independent handpieces with force feedback calibrated to replicate intraocular resistance during cataract and vitreoretinal maneuvers

• Specialized instrument sets for each surgical domain (e.g., phaco handpieces, forceps, vitreoretinal light source)

• Foot pedal control modeling cataract (phaco) and vitreoretinal (vitrector, endolaser) functions to reinforce muscle memory

3. Curriculum Depth & Progressive Training Modules

(Without reproducing proprietary module descriptions)

The simulator incorporates a validated, multi‑level curriculum covering:

• Basic skills (orientation, navigation, anti‑tremor, bimanual coordination)

• Cataract surgery (capsulorhexis, phaco‑divide and conquer, chopping techniques, hydro maneuvers, irrigation/aspiration, IOL insertion, complication management)

• Vitreoretinal surgery (membrane peeling, ILM removal, posterior hyaloid separation, endolaser application, retinal detachment repair)

4. Performance Scoring & Data Tracking

The system shall provide automated, objective, real‑time performance scoring, including metrics such as:

• Instrument path accuracy and economy of motion

• Tremor control and stability

• Tissue handling quality and procedural safety

• Efficiency and time to completion

• Force application and avoidance of iatrogenic trauma

• Longitudinal trainee performance tracking

These analytics support competency‑based assessment and remediation planning.

5. System Safety & Compliance

• Simulator uses no patient data and does not function as a medical device; suitable for training environments without clinical infection‑control burden

• Compliant with applicable electrical and safety directives as documented by manufacturer test data

SOFTWARE: The system shall operate using Haag-Streit Simulation’s proprietary VR software platform, providing realistic anatomical rendering, instrument-behavior modeling, and performance analytics.

TRAINING: The Contractor shall provide on-site training covering system operation, software navigation, curriculum utilization, and routine maintenance procedures.

WARRANTY: The system shall include a minimum one‑year warranty covering parts and labor.

DELIVERY SCHEDULE: Estimated delivery time is 3–4 weeks after receipt of order.