Surgical Ventricular Assist Device, Columbia MO VAMC

Statement of Work

CARDIOHELP DISPOSABLE HLS SET ADVANCED

The Harry S. Truman VAMC is working to establish a rotational stock of our Surgical Ventricular

Assist Devices.

Purpose

The Cardiohelp System (which only accepts the HLS/HIT Set Advanced Disposable) is a blood

oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass

circuit for circulatory and or pulmonary support during procedures requiring cardiopulmonary bypass

(for periods up to six hours). It is also intended to provide circulatory and or pulmonary support

during procedures not requiring cardiopulmonary bypass (for periods up to six hours). The

Cardiohelp System in configuration with the HLS/HIT set Advanced is intended to be used within the

hospital environment and outside the hospital environment (for periods up to six hours), e.g. for

intra-and inter-hospital transport.

Salient Characteristics for the Cardiohelp System Disposable:

• Must connect to the Cardiohelp System currently owned by the hospital

• Integrated Gas exchanger equipped with diffusion membrane

• Integrated Heat exchanger

• Integrated Centrifugal pump

• Three integrated pressure sensors

• Integrated arterial temperature sensor

• Integrated measuring cell for Venous oxygen saturation, hemoglobin, Hematocrit and venous

temperature

• Integrated coated blood tubing set