P09_SON_Erigo Pro_01.docx

Eastern Colorado Health Care System Rocky Mountain Regional

VA Medical Center - Station 554 1700 N. Wheeling Street Aurora, CO 80045

Powered Tilt Table with integrated Functional Electrical Stimulation (FES) & Robotic Lower Extremity Movement Statement of Need

Purpose:

The Rocky Mountain Regional VA Medical Center has a requirement to purchase to supply and deliver the items identified in Table 1 below; (x1) Powered Tilt Table with integrated Functional Electrical Stimulation (FES) & Robotic Lower Extremity Movement. This is a Brand Name or Equal requirement; refer to the salient characteristics below. HOCOMA AG is the basis of design Scope of Work:

Equipment will be shipped in original OEM packaging and will be inspected upon receipt to ensure equipment is free of defect and/or damage. The equipment will ship complete, no partial shipments will be accepted.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

The vendor will provide all applicable service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Tracking information will be emailed to the following Point of Contact (POC):TBD The shipping label and packing slip will contain the following information for ease of receipt:

1) Ship To:

a. Rocky Mountain Regional VA Medical Center, 1700 N Wheeling Street, Aurora, CO 80045

2) Mark For:

a. TBD

3) Contract Number:

4) Purchase Order:

Period of Performance:

This will be a firm fixed contract with an estimated lead time for delivery is approximately 60 days.

Delivery Instructions:

Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays.

Inspection:

Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the government.

Warranty:

The Contractor shall provide all manufacturer’s warranty with products upon delivery. Warranty shall commence upon acceptance by VA representative and verification of operational functionality.

The warranties shall include all travel and shipping costs associated with any warranty repair.

Will also need additional warranty (up to +4 years) to include Preventative maintenance at the 3rd year.

Deliverables:

Operation and Maintenance Manuals Invoicing and Supporting Documentation:

The supporting documentation and invoice shall be submitted within 30 days at the end of each month. Subsequent changes or corrections shall be submitted by a separate invoice. In addition to information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4 (g), all invoices must include the following information:

a. Name and Address of Contractor

b. Contractor’s Tax Identification Number

c. Date of Invoice

d. Invoice Number

e. Contract Number

f. Purchase Order Number

g. Date of Service

h. Contract Line Item Number (CLIN)

i. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of the items delivered

j. Total Price Recalls:

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot or serial numbers where applicable); administrative identification data including order numbers and order date; reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action.

Confidentiality and Non-Disclosure:

This equipment does not connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 6, the C&A requirements do not apply to this requirement, and a Security and Accreditation Package in not required.

This equipment does not hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 7, Appendix B and C provisions do not apply.

Salient Characteristics:

Total Quantity: 1 ☐ Network Required if Checked ☐ Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked ☐ End User Training Required if Checked

Basis of Design is HOCOMA AG, MFG P/N: 29673

· Powered Tilt Table

· Must Include Integrated Functional Electrical Stimulation (FES).

· FES stimulation must be able to synchronize with the leg movement of the tilt table.

· FES stimulation intensity should be able to be adjusted for each channel separately.

· Must be capable of Robotic Lower Extremity Movement.

· Must have Adjustable progressive verticalization of up to 90°.

· Cyclic leg movements must be 8 – 80 steps per minute.

· Must be able to handle mechanical leg loading up to 50 kg.

2 | Page