Information system, patient record

Intended purpose

Digistat Care (hereafter “Product”) is a software that transfers, stores, elaborates, aggregates, organizes and displays patient information and patient related data, including data and events from medical devices and systems as well as information entered manually, in order to drive clinical management providing information to: • Support treatment, diagnoses, prevention, monitoring, prediction, prognosis and mitigation of disease. • Triage or identify early signs of disease or conditions. The Product includes: - Collection of clinical data and events from medical devices and systems in near real-time. - Collection of data entered by the user. - Configurable processing/filters to optimize/reduce the frequency and number of event notifications to healthcare professionals in order to present clinically actionable information. - Visualization of patient data and device status information in near real time and retrospectively, to healthcare professionals on designated display device(s). - Integrator and Communicators of a distributed information system (DIS) intended to provide healthcare professional notification of physiological and technical alarms together with supplemental clinical and non-clinical data to support the monitoring of patients. - Integrator and Communicators of a distributed alarm system (DAS/CDAS) intended to reliably forward and deliver physiological and technical alarms from selected source devices and systems to healthcare professionals on designated display devices and to specified systems. - Elaborations of data to provide additional information to the clinician such as scoring systems and clinical decision support. - Transferring the acquired information to external, clinical and non-clinical systems, in near real-time via a subscription interface, or retrospectively via data query. The Product is a stand-alone software that is installed on specified hardware and relies on proper use and operation of connected medical devices, systems, display devices and the medical IT network. The Product works together with Digistat Docs the other product of the Digistat Suite. The Product is used in healthcare facilities in critical care units, sub-intensive units, general wards and other departments and for limited functions at patient home. The patient population and patient conditions are established by the connected medical devices and systems and by the particular configuration of the product requested by the healthcare organization. The users are trained healthcare professionals with the exception of lay users for limited functions.