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The SpassageQ 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 patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates 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). The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring. The device is intended to provide additional information for use during patient monitoring in a healthcare facility. The device is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population.

The SpassageQ consists of: - An automated algorithm to calculate data and generate qSOFA score and alarm when it is needed. - · An HL7 message receiver to handle incoming connection attempts from HL7 gateway systems, parse HL7 messages, and check the validity of HL7 messages. - · 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 be notified of patients with suspected infection. The SpassageQ system works in the following sequence: - · Receive patient data from the HL7 gateway system. - · Extract 6 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. - · SpassageQ calculates the qSOFA score automatically and stores the result in the database. - · SpassageQ delivers 6 vital signs, qSOFA score, GCS to users. - · When the patient's qSOFA score is 2 points or higher, the users are notified of the patient through a visual alarm, and the alarm shall be reviewed by the qualified practitioner.