SOW-SOL-SYNOPSIS.docx

STATEMENT OF WORK

Project Title: Purchase and custom installation of the ZeroG Gait and Balance System robotic body-weight support system and the ZeroG-Passive static gait training system for over-ground gait training.

Physical Therapy Section

Background:

The NIH Clinical Center (CC) is a 200 bed federally funded, biomedical research hospital located on the NIH campus in Bethesda, Maryland. The Clinical Center is the delivery setting for all NIH intramural clinical research protocols. The hospital complex consists of two main facilities that are connected to each other by "bridges". The original 14-story building is 2.5 million square feet and continues to house the clinical laboratories, imaging sciences, surgical suites, and several outpatient clinics. The new 870,000 square foot facility houses inpatient units and day hospitals. The Clinical Center accounts for about half of all NIH-funded clinical research beds in the United States and accommodates about 7,000 inpatient and 70,000 outpatient visits a year. Patients are admitted to the NIH Clinical Center from all over the world for the sole purpose of participating in a clinical research protocol.

The Rehabilitation Medicine Department (RMD), is located in the Mark O. Hatfield Clinical Research Center of the National Institutes of Health and is composed of several disciplines including the Medical section, Physical Therapy section, Occupational Therapy section, Speech Language Pathology section, Functional and Applied Biomechanics laboratory and the Recreation Therapy section. The Rehabilitation Medicine Department collaborates with institute physicians in research protocols, conducts independent research, and provides clinical consult services for 27 institutes and centers. When a patient presents with conditions or impairments affecting safe and independent mobility a clinical consult request is generated for the Rehabilitation Medicine Department, Physical Therapy Section. Physical Therapy services are rendered Monday through Saturday and holidays or as needed to provide assessment, intervention, and professional insight to assist with the patient’s plan of care.

Purpose:

RMD Physical Therapists collaborate with institute physicians in research protocols and receive clinical consult requests from 27 institutes and centers for in-/out-patient services for patients who present with conditions or impairments affecting safe and independent mobility.

Fall protection and dynamic body-weight support promotes early intensive therapy. The ZeroG® Gait and Balance System protects patients from falls while providing dynamic body-weight support as patients practice, sit-to-stand maneuvers, walking, postural re-education, balance tasks, getting off the floor, and even management of stairs. ZeroG can maintain a consistent level of body-weight support regardless of vertical movements. Because ZeroG is mounted to an overhead track, there are no barriers between the patient and therapist. The motorized trolley automatically tracks patient movements up to 5 mph. Patients only feel the vertical unloading without any drag from behind. Patients are secured into a harness and then connected to the spreader bar in under 5 minutes. Settings from the patients’ previous sessions are easily accessible, so therapy can start immediately. ZeroG has advanced fall protection measures which monitor patient movements at 1,000 times per second. ZeroG has been used to train hundreds of thousands of patients since 2008 without a single patient or therapist injury per company data. With ZeroG, patients can begin rehabilitation in a safe, controlled environment.

All NIH ICD’s would benefit from the utilization of this equipment as it would expedite clinical assessment and maximize outcomes by facilitating intensive therapy sessions earlier in recovery.

Scope of Work:

The contractor shall furnish and provide custom installation of one ZeroG Gait and Balance System robotic body-weight support system and track in the Physical Therapy gym, room 1-2460 NE, and one ZeroG-Passive static gait training system and track in the corridor adjacent to room 1-2460 in the Rehabilitation Medicine Department, Physical Therapy section of the Clinical Center.

Minimum Requirements/Specifications: Quantity One of each specified equipment is needed.

Required Specifications for the ZeroG Gait and Balance System robotic body-weight support system, the ZeroG-Passive static gait training system, and the associated tracks shall meet or exceed the technical specifications identified below: All items must be new. Used or remanufactured equipment will not be considered for award.

ZeroG Gait & Balance System – Part ZGGB-V301

· Robotic Trolley

· Static BWS: 0-450 lbs

· Dynamic BWS: 10-200 lbs

· User Interfaces

· Touchscreen computer on mobile cart

· Wireless remote

· Track

· Up to 100-feet, shape customized to space

· Fall Protection

· Distance

· Velocity

· Dynamic Fall Recovery and Fall Cushioning

· TRiP Balance Training: Perturbations during balance or walking activities

· Advanced Trolley Modes:

· Free Walk

· Resistance

· Facilitation

· Kinetics: Interactive balance games and training modules

· Studio: Video recording of patient’s training session

· Four (4) Harnesses: Sizes: XS, S, M, L, X-Large, 2X-Large, 3X-Large

· Planning & Installation: By Engineers and certified installers

· Safety Certifications: Medical device safety & performance; emissions & immunity; FDA listed

ZeroG-Passive Gait Training System – Part ZGP-100

· Hardware

· Passive Static Trolley

· Capable of static unloading (0-450 lbs)

· 50-feet of Straight I-Beam Track

· Aluminum I-beam, powder-coated bright white

· Note: If purchased in conjunction with the ZeroG gait and balance system, a total of 150 feet of track will be included for both the ZeroG and ZeroG-Passive systems.

· Harnesses

· 3 included, sizes chosen by customer

· Installation

· Structural analysis by professional engineer

· Installation planning with full-service installation by certified installers

· Custom Track Installation

· Composite beams for track mounting to existing structure

· Hardware and bracing

Required Delivery Specifications:

The government’s required delivery date is 3 - 5 weeks from the date of request. The Contractor must arrange for “White Glove” delivery to the National Institutes of Health dock, transport the systems directly to the Rehabilitation Medicine Department Physical Therapy Section, Gym 1-2460 NE, and provide custom installation of the ZeroG Gait & Balance System – Part ZGGB-V301 and tracks in the Physical Therapy Gym, rm 1-2460 NE, and the ZeroG-Passive Gait Training System – Part ZGP-100 and tracks in the adjacent corridor to the Physical Therapy Section Gym, room 1-2460 NE, located at:

National Institutes of Health Rehabilitation Medicine Department Building 10, room 1-2460 10 Center Drive, MSC-1604 Bethesda, MD 20892

The Contractor shall furnish all necessary labor, materials, supplies, equipment and services to perform the work necessary for the system to function properly.

Inspection and Acceptance:

· Inspection and Acceptance will take place at the deliver to location.

National Institutes of Health Rehabilitation Medicine Department Building 10, room 1-2460 10 Center Drive, MSC-1604 Bethesda, MD 20892

· The Contracting Officer’s Representative (COR), to be determined at time of award, will inspect and accept goods and may perform operational tests to ensure the equipment performs in accordance with the outlined.

Training:

· Full-day of onsite training and online training modules

Warranty:

· Two (2) year complete warranty

· One (1) year on harnesses

Regulatory Compliance:

· All contractor furnished products must be UL and C-UL classified, ISO (International Organization for Standardization), and CE (European Conformity) compliant. They must meet all FDA clearances, and have received ADA acceptance.

· The equipment must be in compliance with the FDA Good Manufacturing Practices for medical devices and equipment. The equipment shall be in compliance with the FDA Safe Medical Devices Act, “Safety Medical Act of 1990” by Frank E. Samuel, Jr.

Evaluation Criteria Physical Therapy Section Rehabilitation Medicine Department, CRC, NIH

ZeroG Gait & Balance System – Part ZGGB-V301, ZeroG-Passive Gait Training System – Part ZGP-100, and accompanying parts

For the purposes of the award, selection will be made based on the best product and vendor who possess equipment, experience, education, interpersonal skills, and ability to fulfill the Government’s requirements for the ZeroG Gait and Balance System robotic body-weight support system and the ZeroG-Passive static gait training system. In determining the best overall applicant, the following criteria will be scored with the corresponding maximum point values for each area, yielding a total of 100 obtainable points.

Total 100 points

75 points award

The ZeroG Gait and Balance System robotic body-weight support system and the ZeroG-Passive static gait training system for early initiation of over-ground gait training, sit-to-stand transitions, postural re-education, balance activities, fall recovery training, and stair training in a safe, controlled environment.

25 points award

The warranty service and support should apply to all hardware, parts and labor along with installation, onsite training and available customer service. The company should provide White Glove delivery and onsite assembly. Inspection and testing of electrical/ moving parts and safety devices will be completed upon delivery.