Testing and Evaluation of the Seabrook Medical Systems, Inc. ECMO-Temp Blood Warming Unit, Model SMS-3000.
Abstract:
The Seabrook provides a flow of temperature controlled water to a heat exchanger. This heat exchanger is connected in the blood flow path in series between the oxygenator and the patient during an ECMO procedure. The Seabrook provides a means for warming and controlling blood temperature prior to and during perfusion. The EUT consists of a plastic reservoir for holding distilled water a float switch to indicate low water level a pump for circulating water through an external heat exchanger a heating element to warm the water a microprocessor-based electronic control to regulate water temperature two independent back-up high limit devices to protect the patient and the unit a water flow indicator to provide visual assurance of proper water flow two connecting hoses for attachment of the heat exchanger and 2 fan for removing heat generated within the unit enclosure. A phone jack marked Blood Probe allows connection of a 400 series-type thermistor probe for monitoring andor controlling blood temperature. Audible and visual alarms indicate Add Water, Under Setpoint, Over Setpoint, and High Limit. Digital displays indicate water temperature, setpoint, and blood temperature when a probe is connected, in degrees centigrade. The Seabrook operates from 115 VAC60 Hz power and weighs 24 lbs dry. The dimensions are 9.75 in. W. X 14 in. H. X 11 in. D.