SOW_Heater Cooler.doc

STATEMENT OF WORK

Heater-Cooler System Veterans Affairs Health Care System Oklahoma City, Oklahoma

1. General: Currently, the Oklahoma City Veterans Affairs Health Care System (herein after referred to as OKC VAHCS) Surgery Service requires a Heater-Cooler System, required for the circulation of water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or more.

2. Delivery Location: Oklahoma City Veterans Affairs Health Care System, 921 N.E. 13th St. Oklahoma City, Ok 73104

3. Delivery Times: Delivery times shall be Monday through Friday from 07:00 to 16:00 (7:00AM to 4:00PM).

4. Definitions/Acronyms

4.1. OKC VAHCS: Oklahoma City Veterans Affairs Health Care System

5. Scope: The Contractor will provide the necessary equipment and accompanying software to the OKC VAHCS for one (1) Heater-Cooler System for cardiac surgeries. Additionally, the requirement is for a comprehensive and whole solution to the requirement. The Contractor is required to be an expert in the field of heater-cooler systems, specifically within the field of cardiac surgery. As such, the Contractor is required to include any items not specifically listed in the pricing schedule but is necessary to enable the equipment or accompanying software to function. Examples include installation expenses, VA staff training, equipment mounts, display charts, cables, connectors, plugs, and special equipment wiring requirements. The company will be responsible for replacing any machines that malfunction, break, or are not adequately operating at no additional cost to the VA within the first 12 months of purchase. The company will work with OKC VAHCS Biomedical Engineering Department to coordinate any preventive maintenance or replacement of any machine.

6. Training for VA Employees: Comprehensive training or VA staff is required. Examples include: Physicians, Nurses, Surgical Technicians, and Biomedical Engineers.

7. Specifications:

7.1. Below are salient characteristics for the Brand Name or Equal requirement:

· Must be capable of treating the following:

· Used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less

· Must be capable of performing or have the following:

· Three circuits, controllable from control display panel:

· Cardioplegia circuit

· Temperatures that can be controlled from independent heating and cooling tanks

· Has tank drain valve

· Two tanks

7.1.....1. Cold cardioplegia tank

7.1.....1.1. Temperature range: 2° C to 10° C or better 7.1.....1.2. Tank volume: 3 L or better 7.1.....2. Warm cardioplegia tank

7.1.....2.1. Temperature range: 15° C to 41° C or better 7.1.....2.2. Tank volume: 3 L or better

· Patient 1 circuit

· Can be used with oxygenator, and/or

· Single-use heating/cooling blanket

· Can be controlled from one heating/cooling tank

· Patient 2 circuit

· Can be used with oxygenator, and/or

· Single-use heating/cooling blanket

· Can be controlled from one heating/cooling tank

· Patient tank

· Temperature range: 2° C to 14° C or better

· Has tank drain valve

· Aerosol collection container holder

· ½” tubing connectors

· 1/2” tubing connectors, 90-degree angle

· Potential equalization cable

· Screwdriver for zeroing the vacuum gauge

· Vacuum gauge with scale, to indicate the vacuum level inside the tanks

· Vacuum gauge service port for removing potential obstructions within the internal pressure monitoring line

· Filler neck with cap for filling all tanks with filtered tap water

· Overflow outlet for draining excessive water from the tanks and for connecting the aerosol collection container

· Fan for ventilation of the heater-cooler

· Castors with brakes

· Bumper to protect the valves, drains, etc against accidental crashes

· Control panel

· Used to adjust temperature set values

· Used to start and stop circuit pumps

· Displays all set and actual temperatures

· Displays water level in all tanks

· Water level display with multi-color indicators

· Must meet the following:

· Can be in-use for up to six (6) hours or better

· Suitable for continuous use

8. Security Requirements: The contractor will have no access to patient records or areas of the hospital. The A&A requirements do not apply, and a Security Accreditation Package is not required.