Attachment 1 Statement of Need Letter Automated Circulatory Assist Unit.pdf

Statement of Need for

60 HCOS/Cardiac Cath Lab Automated Circulatory Assist Unit w/Cart

Description: The automated circulatory assist unit is a device designed to assist/pull blood from the left ventricle of the heart and inject said volume into the aorta for distribution throughout the body. Basically, taking over the function of the heart to distribute blood. This device is programmable to deliver various levels of output and is currently the only one of its kind on the market. This equipment is already used by the Cardiac Cath in-house and is implemented for increasing the cardiac output of the heart during and or after cardiac procedures. This is an “Open Market” request.

POC: TSgt Kyle Watters

Unless determined otherwise, the vendor will provide the following:

1. Machine

1.1. Must be able to connect to Impella implanted devices for power, monitoring, and adjustments as needed during patient transports.

1.2. Must display waveforms indicating its position in relation to the aortic valve.

1.3. Must show pictogram of the heart and device placement based on the waveforms seen on the placement screen.

1.4. Must display an hourly history of total volume, heparin, and dextrose concentration being infused from the purge system.

1.5. Must display purge flow and purge pressure trends overtime.

1.6. Must display mean flow as well as maximum flow during systole and minimum flow during diastole.

1.7. Must show current infusion rate for the purge solution and current purge pressure.

1.8. Must have the ability to stabilize patient’s hemodynamics and unload the heart, which allow the muscle to rest and potentially recover its native function.

1.9. Must have battery life of a minimum 2 hours or ability to connect to an external power source for up to 2 hours of power for transporting between vehicles.

1.10. Must be portable to fit in transport vehicles for movement between medical centers worldwide.

1.11. Must be visible in various lighted conditions.

1.12. Must have visible and audible alarms for various noise environments encountered during transports.

1.13. Must include cart for patient transports.

1.14. Must be FDA-approved device for High-Risk Percutaneous Coronary Intervention procedures.

1.15. 60 days delivery upon order.

1.16. Must have at least 12 months warranty.

2. Point of Contact after the contract is awarded:

2.1. Coordinate with Mr. Paul Plamenco at DGMC at 707-423-7506.

3. Qualifications/Certifications: N/A.