4 STATEMENT OF WORK (SOW) as of 22/Feb/2017 Contracting Officer s Representative (COR). Name: Roman Wynnyckyj Section: Medicine Service Address: 1501 San Pedro Dr. SE, Albuquerque, NM 87108 Phone Number: (505) 767-6003 Fax Number: (505) 256-2803 E-Mail Address: [email protected] 2. Contract Title. BRAND NAME ONLY -The government is requesting to purchase 4 (four) ERBE / VIO 300D Electrosurgical Units. 3. Background. We request the purchase of 4 (four) ERBE electrocautery - APC Coagulator units.  Since the bulk of procedural work in a gastroenterology lab includes colonoscopy and esophagogastroduodenoscopy, the prompt availability of Electrocautery and APC units to allow for safe diagnostic and therapeutic intervention such as polypectomy, control of bleeding and sphincterotomy etc., is key to the efficient daily running of any GI Endoscopy unit in the country. 4. Scope. Currently we have only one such unit which is shared by 6 procedural rooms and this equipment is moved around from room to room multiple times every day, thereby decreasing efficiency and productivity. It ties up highly trained staff members who are then engaged in the menial task of pushing around equipment.  Additionally, it increases procedural time for the physician and nursing staff and adversely impacts patient safety.  The prompt availability of electrocautery and APC units is mandatory to performing invasive GI procedures and is the community standard of care. We request the purchase of this equipment as an urgent action to be able to perform necessary and lifesaving procedures on our veterans in a safe and efficient manner and increase the efficiency and productivity of our unit.  5. Specific Tasks. 10134-000 ERBE | APC 2 Argon Plasma Coagulator with choice of Precise APC® (with automatic output adjustment as distance from tissue varies) and two Pulsed APC® modes. Socket Configuration: Filter Integrated APC (w/ ability to accept all FiAPC® probes, including Circumferential). QTY = 1 20134-006 ERBE | APC 2 PRESSURE REDUCER WITH SENSOR QTY = 1 20180-000 ERBE | VIO® CART W/FOOTSWITCH HOLDER, CABLE WRAP AND 1 TANK FIXATION KIT QTY = 4 20180-010 ERBE | VIO® CART WIRE BASKET QTY = 4 20180-134 ERBE | VIO® TO APC 2 FASTENING SET QTY = 4 20180-131 ERBE | VIO®/APC 2 TO VIO CART FASTENING SET (W/GROUNDING CABLE) QTY = 4 20183-072 ERBE | IGNITION TESTER QTY = 1 10140-100 ERBE | VIO® 300D Electrosurgical Unit 120V/60Hz UL, Software Version QTY = 4 29140-218 ERBE | ENDO CUT® IQ UPGRADE (WITH ABILITY TO ADJUST EFFECT, CUT DURATION, AND CUT INTERVAL) QTY = 4 20189-305 ERBE | VIO® TWO PEDAL FOOTSWITCH W/ REMODE® & BRACKET (REMOTELY CHANGES SETTINGS VIA FOOTSWITCH) QTY = 4 INCLUDED SOFTWARE: NESSY® (PATIENT PAD MONITORING SYSTEM INCLUDES ABILITY TO MEASURE PAD ORIENTATION) 20192-125 ERBE | MONOPOLAR CONNECTING CABLE BOVIEJACK 8; 4MM SOCKET; LENGTH 4 M (13.2 FT) | EA QTY = 4 20192-130 ERBE | MONOPOLAR CONNECTING CABLE BOVIEJACK 8; 3MM SOCKET; LENGTH 4 M (13.2 FT) QTY = 4 1063-2 ERBE | ARGON GAS TANK-FULL, 40 CU FT CAPACITY PURITY 99.998% QTY = 1 TRADE-IN 1 ICC 200/APC300 QTY = 1 ****ERBE VIO 300D TECHNICAL SPECIFICATIONS**** Constant Voltage Platform with Automated Power Regulation (adjustment) Cut Mode: ENDOCUT IQ Cut Mode: Dry Cut Cut Mode: Bipolar Cut ++ Coag Mode: Spray Coag Power Peak System (PPS) ReMode Functionality (Ability to change power settings with foot pedal) NESSY (Neutral Electrode Safety System) Upgradable to Multifunctional Socket that will accept BiClamp hand pieces and Wolf Resectoscopes Compatible with ERBE Argon Plasma Coagulator model APC2 Compatible with ERBE Jet2 High Pressure Water Jet Dissector Compatible with ERBE Hybrid Knife Pulsed APC compatible (with constant high-frequency voltage) Precise APC compatible FiAPC Probe compatible Circumferential APC Probe compatible Compatible with BIPOLAR RESECTION Adapter: adapter designed for use with RICHARD WOLF vaporization electrode. Compatible with Richard Wolf Resection Equipment 6. Performance Monitoring Vendor performance will be monitored by Biomedical Engineering, the COR, and GI Endoscopy staff to ensure that work is completed as stipulated by the contract. Work completed will be reported to the COR to ensure that contractual conditions are met. 7. Security Requirements Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. The C&A requirements do not apply and a Security Accreditation Package is not required. 8. Other Pertinent Information or Special Considerations. a. Inspection and Acceptance Criteria. The equipment will be shipped to our receiving department and inspected and approved for patient use by our Bio Med Service before delivery to the MICU. 10. Risk Control Any infection control or other potential risks will be mitigated or resolved by the appropriate department. 11. Place of Performance. This equipment will be housed and used in the GI Endoscopy Suite at the NMVAHCS, 1501 San Pedro Drive SE, Albuquerque, NM 87108.

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