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NAVOYCDS is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in adult patients being monitored in a healthcare facility. The device uses an algorithm to calculate a qSOF A score (also known as quickSOFA) which indicates adult patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale <15). NAVOYCDS is an adjunct to and is not intended to replace vital signs monitoring. NAVOYCDS is intended to provide additional information for use during patient monitoring in a healthcare facility. NAVOYCDS is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population.

NAVOYCDS consists of: • A gateway module for handling clinical data supporting the HL7 format FHIR. • A qSOFA score module to calculate patients' qSOFA scores and offer their last 72 hours history data. · A web-based dashboard to render patients' qSOFA scores in a visually distinctive way depending on their value and enable intended users to view patients with suspected infection. The NAVOYCDS system works in the following sequence: - · Receive patient data from the HL7 gateway system. - · Extract 3 vital signs from the patient data and store them in the database. · The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it. · NAVOYCDS calculates the qSOFA score automatically and stores the result in the database. · NAVOYCDS delivers 3 vital signs. gSOFA score, GCS to users. · The qSOFA score is presented in a visually distinctive way depending on the value and enables users to view patients with suspected infection.