Cardiopulmonary bypass system heat exchanger, single-use

Intended purpose

The Quantum PureFlow Heat exchangers are indicated for use with Spectrum Medical Heater cooler systems to heat/cool blood or perfusion fluids for periods lasting less than 6 hours for either (i) Full or partial cardiopulmonary bypass (with an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava. This is a single use device.