DIRECTED SYSTEMS LIMITED HDA-OR2 Hypotension Decision Assist (HDA)

Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon amedically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, fromwhich it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numericparameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derivedvariables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemicvascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allowsthe user to mark the administration of vasopressors and volume challenges to the MAP trend.