P01_SON_ Gait Safety System_Brand name or equal.docx

Eastern Colorado Health Care System Statement of Work Gait Safety System

GENERAL: Eastern Colorado Health Care System (ECHCS), Physical Medicine and Rehabilitation Service (PMRS), has a requirement for a Dynamic Body Weight Support System. The system will be delivered to Rocky Mountain Regional VA Medical Center (RMRVAMC) at 1700 N. Wheeling Street, Aurora, CO, 80045 and the final install location will be the PFC Floyd K. Lindstrom Outpatient Clinic in Colorado Springs located at 3141 Centennial Blvd. Colorado, Springs, CO 80907. This requirement is a Brand Name or Equal to the Bioness Vector Gait System – Elite Model.

BACKGROUND: The Gait and Safety System is a ceiling-mounted robotic system designed to accelerate physical rehabilitation of patients with severe gait and balance impairments. The system provides dynamic body weight support and trolley tracking, enabling the patient to practice gait and balance training by offloading a portion of their body weight. System must detect and prevent falls before they happen to keep patients safe and instill confidence.

System needs to be UL Certified Dynamic Body Weight Support System supporting a patient weight capacity of 500 lbs.

· Falls prevention – while secured patients can safely perform balance reactions and experience mistakes to achieve motor learning and develop effective movement strategies.

· Boost productivity – 1:1 patient to therapist ratio

· Faster recovery – promote faster rehabilitation times, begin treatment earlier, push limits, and shorten lengths of stay.

PURPOSE: The equipment will enhance the ability of the PMRS’ therapists to effectively treat patients with balance and gait impairments under truly safe and optimal conditions for motor learning.

SCOPE: ECHCS requests contractors provide brand name or equal equipment that meets or exceed the physical, functional and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the need of the government.

PHYSICAL CHARACTERISTICS: Equipment must have the physical characteristics to enable the government to perform the capabilities:

Dynamic Body Weight Support System Requirements

· A ceiling mounted robotic trolley which provides dynamic body weight support

· System safety must be guaranteed by UL Certification (to IEC-60601 3rd edition)

· The system must be qualified and manufactured in an ISO-13485 compliant medical manufacturing facility

· The system must be FDA Compliant and Registered with specifically FDA Listing D203102

· Maximum weight capacity must be 500 pounds or more

· Dynamic unloading weight capacity must be 200 pounds or more

· The maximum trolley speed needs to be capable of 5 miles per hour

· The trolley must be able to detect motion at 1,000 times per second or faster

· The rope let-out speed (patient fall speed) must be controlled by the trolley winch motor and should not exceed 0.45 meters per second

· Both distance-based and velocity-based fall detection modes must be offered by the system

· Capacity to support 2 robotic trolleys on the same track

· Windows/Android software operating system

· System must have the ability to set track limits or soft walls with any mobility modes, both horizontal and vertical trolley tracking

· Emergency Stop and Emergency Lower must be available on every screen interface on both the system computer station as well as the handheld controller

· The following standardized outcome measures must be able to be administered directly from the dynamic system: Timed Up and Go, 10 & 5 Meter Walk Tests, 2 & 6 Minute Walk Tests

· The system’s attachment mechanism of the harness must have magnetic and locking carabiners

· The attachment mechanism of the harness must have three attachment positions to accommodate to veterans of varied sizes

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Equipment must provide the following functional and performance capabilities:

Clinical Training & Support Requirements

· The provider of the dynamic body weight support system must have a minimum of one local representative who live locally within the state in which the system will be installed.

· The provider of the dynamic body weight support system’s local representatives must be licensed physical and/or occupational therapists

· The provider of the dynamic body weight support system must provide both an initial training and a follow up training to certify the competency of system understanding at no additional cost/charge

· The provider of the dynamic body weight support system must provide follow-up training upon request for new-hire staff at no additional cost/charge for the life of the system

Electrical Specifications & Requirements

· The system must use a Power System with:

· Inlet power - standard 110 VAC, 50/60Hz, 1.8KW

· Outlet Power: 240 VAC 50/60 Hz (to the power rail of the track)

· Inlet Connector: IEC320-C14

· Output Power: rated 10 1800VA, 7.2A (1.8KW)

· Wall mounted power box with ON/OFF switch

· Size: 15” (h) x 14.5 (w) x 4.0” (d), including brackets

Installation & Track Specification Requirements

· Custom track layout provided per discretion of facility

· L-Shaped track approximately 30’ x 16’

· Track design will include reflective ceiling plan

· Structural attachment details to be applied and calculated and provided to the facility based on the determined layout and properties of the facility structure

· Stamped structural engineering documents are to be created and provided to the facility upon purchase of the dynamic body weight support track system

· Installation of the dynamic body weight support system shall consist of:

· Attachment and assembly of the upper structure including necessary hardware, strut, bracing, etc.

· Mounting of the mechanical I beam to the upper structure

· Mounting and assembly of a power rail

· Mounting of the robotic trolley(s)

· Mounting of the power supply box to the wall at a specified and agreed upon location

· Setup and configuration of the PC and handheld controls

· System programming, commissioning, and load test to 2.5 times the maximum weight capacity (1250 pounds)

· Measurements/Distance from Ceiling Grid to the above structure is 43”

· Measurements/Distance from Ceiling Grid to the floor is 106”

HIPPA Compliance Specifications & Requirements

· Access Control:

· System must have two levels of password protected access (Windows login then software PC application user login)

· Capability to provide each user with his/her own password protected account in addition to the administrative user login/account

· Automatic logoff after 15 minutes of inactivity

· Database

· The database must be encrypted, and password protected to ensure unauthorized access. A secondary back up of the database must also be provided and encrypted in the same manner.

· Veteran information is only accessible via the software application

· Communication

· The system must use a private wireless network and not be connected to the internet

· Communication between the system components do not transmit any veteran information and data is not tagged with any patient identifier

Preventative Maintenance Specifications & Requirements Base plus 4 Option Years

· An optional annual preventive maintenance (PM) must be available

· The annual preventive maintenance must include the following service characteristics:

· Inspection of all system components including robotic trolley, PC, handheld device, mechanical I-beam, power rail, power supply

· Wearable parts must be replaced or repaired at no charge during initial two-year warranty or with purchase of extended warranty

System calibration

· Cleaning of the robotic trolley, mechanical I-beam, power rail, spreader bar and power supply

· Certified technician travel expenses for 1 scheduled PM visit to the system site per year is included

· Labor to perform 1 PM visit per year is included

· If additional, non-wearable parts are found to require replacement they will be invoiced to the facility

· Service reports will be provided within 15 business days of completing the annual PM

· Servicing and/or replacement is completed if a component fails inspection criteria.

An itemized list of parts inspected and addressed with the PM:

· Robotic Trolley

· Wheels, pinch rollers, rope assembly, rope pulleys, winch drum, hubs, finder guard, main power inlet, cam surface and follower, spring cage, tow bar, bumpers, spreader bar assembly, carabiners

· Personal Computer and Handheld Device

· Software version verification, critical software updates (if applicable), hard disk health check, hard disk space check, Wi-Fi verification, system calibration

· Mechanical I-beam

· Check alignment and spacing, check grounding wires, hard desk health check, inspect fasteners and hardware, inspect end stops (track bumpers)

· Power Rail

· Inspect segment alignment, inspect copper conductor connections, inspect hanger assemblies, and end caps, inspect line feed connection, inspect collector, check voltage

· Power Supply

TRAINING: Contractor is to provide 2 days of onsite training after installation. Government will not require additional training. Provide 24/7 technical support.

WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

DELIVERY SCHEDULE: All items to be delivered and or installed within 60 days of purchase order processing and order placement.

PLACE OF DELIVERY: Rocky Mountain Regional VA Medical Center, 1700 N. Wheeling Street, Aurora, CO 80045. ECHCS staff will transport equipment to final installation location prior to install.

PLACE OF INSTALLATION: PFC Floyd K. Lindstrom Outpatient Clinic in Colorado Springs located at 3141 Centennial Blvd. Colorado, Springs, CO 80907.

DELIVERY POC: All delivery, install, and training shall be coordinated with the following POCs: TBD

PERIOD OF PERFORMANCE: The requirement is for one base year plus four (4) option years to include preventative maintenance for the system. Requesting the period of performance for preventative maintenance begin once installation and training are completed.

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