6515--Endoscope Inspection Scopes

CTVHCS Central Texas Veterans Health Care System ENDOSCOPE Inspection scope Statement of Work (SOW) GENERAL The contractor shall comply with Federal, State, local laws and regulations applicable to the performance of this contract. The Central Texas Veterans Health Care System (CTVHCS), Sterile Processing Service (SPS) requires the purchase of a device that enables the internal inspection of endoscopes with small internal lumens. These endoscopes are primarily used in ENT, GI and Urology procedures. This equipment is used to see inside an endoscope as part of the cleaning verification procedures and to identify damaged internal structures. GENERAL REQUIREMENTS The contractor/vendor shall provide equipment suitable to provide the CTVHCS-SPS for internal visual endoscope inspection to identify hidden damage or ineffective cleaning: cracks, residue, integrity of fiber optic bundles with at least 12x magnification. The device will have separate inspection scopes of various lengths and diameters less than 2.1mm that are easily exchanged from a wall mounted, adjustable positioning well lit, HD monitor device with internal light source for endoscope fibers that are attached. No separate light source. Monitor must be visible in a brightly lit work area. Monitor must be waterproof and cleanable with hospital disinfectant wipes. The fiberoptic inspection scope attachments are required to be waterproof at IP68 certification level and need to be able to be either high level or thermally disinfected, preferably both methods. Fiberoptic attachments need to be less than 2.1 mm in diameter x at least 900 mm length for GI endoscopes and a 2nd fiberoptic attachment that must measure no larger than 1.1 mm diameter by no less than 750mm length for small ENT and GU endoscope lumen inspections. The inspection devices are intended to be used in a wet work area and must (required) function without being connected to a computer or internet. The vendor will provide training in use and re-processing. Vendor will provide 3 copies of IFUs and instructions for use. Vendor will in-service to SPS staff. 2.2. The Contractor is expected to respond with 24 hours of the maintenance call. Reports of service and validation are to be provided to Biomed after every service or repair. 2.3. EQUIPMENT REQUIREMENTS a. Salient characteristics, technical specifications shall be met for consideration. SHALL INCLUDE ALL THE FOLLOWING for consideration: see below Key Features Non-latex, medical-grade, water-proof 100 150 V~ 50/60 Hz or 220 240 V~ 50/60 Hz 350 x 2 mm (standard) 950 x 2mm GI length 350 x 1mm Mini Must be able to accommodate a scope of up to 900mm in length. Must be flexible to fit inside the lumen of a flexible endoscopes. (Bronchoscope, EGD, Colonoscope) or other lumened device. Must include a camera for direct visualization onto a video screen. Must include a separate screen display that is able to be wall mounted or computer monitor swing arm mounted. Must include a distal tip light and camera. Must be waterproof. Must be able to withstand high level and thermal disinfection. Must meet AAMI ST91 recommendation for visual inspection to identify hidden damage or ineffective cleaning: cracks, residue, integrity of fiber optic bundles with magnification. Must be able to operate without a computer or internet connection Must include a wall mount stand to hold monitor during inspection Recommended operating temperature: 10 to 40°C (50 to 104°F) Recommended air pressure: 9.0 to 15.3 psi Equivalent to 4,000-meter altitude To visualize the condition of the inside of an endoscope or lumened instrument. Uro-cystoscope, Esophagoscopes, Colonoscopes, and Bronchoscopes and video processor For Illumination and Visualization to determine cleanliness and endoscopes are damage free For use to see inside an endoscope as part of the cleaning verification procedures. 3. DELIVERY AND INSTALLATION 3.1. Equipment shall be delivered to the main facility below: CTVHCS Warehouse 204 1901 S. 1st St. Temple TX 76504 Attn SPS-123T deliver to room BD100 3.2. The contractor shall provide start-up assistance and operator instructions on DELIVERY. Contractor shall install, provide service level technical training for maintenance, troubleshooting, and repair to bio-medical personnel. 3.3. The contractor shall provide three (3) hard-copies (paper) Operator s Manuals and three (3) hard-copies (paper) of Technical Service Manuals to SPS. 4. WORK HOURS: 4.1. Normal Work Hours: The service schedule shall be developed between the contractor and Contractor s Representative (COR) prior to any service/delivery being performed. 4.2. The following is a list of U.S. Government holidays. If the holiday falls on a Saturday, the proceeding Friday is observed as the holiday; if the holiday falls on a Sunday, the following Monday is observed as the holiday and any other day specifically declared by the President of the United States to be a national holiday. HOLIDAY DATE New Year s Day Jan 1 Martin Luther King s Birthday 3rd Monday in Jan President s Day 3rd Monday in Feb Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in Sep Columbus Day 2nd Monday in Oct Veterans Day Nov 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25 5. PERSONNEL 5.1. Personnel. The contractor shall provide in writing the name and phone number of a person within (10) ten calendar days of the award of the contract. The personnel shall be a qualified and experienced to oversee the personnel assigned to perform the installation and maintenance services. The contractor shall correspond with the COR on a regular basis to discuss any problems that the contractor or contractor s personnel may be experiencing during the performance of this contract. Unresolved problems shall be referred to the Contracting Officer for resolution. 5.2. Contractor Service Personnel (CSP). All subcontractors performing work for primary contractor shall meet all specifications and standards that apply to CSP under this agreement. CSP shall maintain clean and neat appearance and shall wear an identification badge always when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the outer garment. The COR shall furnish this badge. Due to conflict of interest, the contractor shall not employ a current DOD employee, military or civilian to provide services under this contract. 5.3. Government point of contact (POC). The COR shall be the Government s POC. If required, the COR shall be designated in writing to the Contractor and the scope of authority shall be set forth therein. Contractor shall respond only to calls from COR or a designated representative from the Medical Center. 5.4. SECURITY STATEMENT: The Vendor and all VA employees are required to immediately report any security violations to the Information Security Officer. - No other security statements are required. 6. ACRONYMS AND DEFINITIONS 6.1. Contracting Officer (CO). A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. 6.2. Contracting Officer s Representative (COR). An individual designated in writing by the Contracting Officer to act as an authorized representative of the Contracting Officer to perform specific contract administrative functions within the scope and limitations as defined by the Contracting Officer. 7. EQUIPMENT OWNERSHIP. 7.1. Title to equipment shall remain with the contractor until a satisfactory inventory and inspection is completed by Contractor, COR and Maintenance personnel. Upon approved inspection, title, equipment, accessories and ownership shall be released to Central Texas Veterans Health Care System (CTVHCS). 8. LIMITED WARRANTY. 8.1. All equipment listed to the attached quote, shall be fit and sufficient for the purpose intended as set forth in the user manuals; and merchantable, of good quality and free from defects in materials or workmanship; for a period of one (1) year from the date of the first invoice under this agreement. The contractor shall provide a minimum of one (1) year warranty. The warranty will begin upon date of acceptance.