Search Results

The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.

AITRICS-VC is a clinical decision support software that receives in-hospital patient information, including physiological parameters such as vital signs and blood test results from EHR and conducts rule-based calculations for conventional early warning scores, which include NEWS (National Early Warning Score), MEWS (Modified Early Warning Score), and qSOFA (quickSOFA). The AITRICS-VC screens patients who meet predefined criteria based on single values of physiological parameters and early warning scores. It displays a multi-patient dashboard and detailed pages for individual patients via a web browser on clinicians' PCs.

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.

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.

The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0. The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - . To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in . clinical decisions and deliver patient care in a timely manner. The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices: - · Airway flow, volume, and pressure - · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - · Bispectral index (BIS, signal quality index, suppression ratio) - · Cardiac Index - . Cardiac output - Central venous pressure . - . Cerebral perfusion pressure - · End-tidal CO2 - · Heart rate - · Heart rate variability - Intracranial pressure . - . Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) . - · Premature ventricular counted beats - · Pulmonary artery pressure (systolic, diastolic, and mean) - · Pulse pressure variation - · Pulse Rate - · Respiratory rate - · Right atrium pressure - · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - · Umbilical arterial pressure (systolic, diastolic, and mean) The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The T3 Data Aggregation & Visualization software module can display information captured by the T3 Adult Risk Analytics Engine software module. The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. System features include: - · Customizable display of physiologic parameters over entire patient stay - Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint - Software-only solution no new bedside hardware required - Highly reliable and robust operation - Auditable data storage

The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population.

Biovitals Analytics Engine consists of: - An automated proprietary algorithm to analyze data and generate Biovitals Index. - A cloud-based database to store the input, intermedium output and the final output - A web application programming interface (API) which handle the continuous physiology data. - A web application programming interface (API) query the databases and get output. - A web dashboard to render the BA Engine output in a continuous graph format, which can help intended users to monitor a patient's Biovitals Index. Biovitals Analytics Engine works in the following sequence: - Accept input data via secure API; - Analyze the input data using Biovitals Analytics Engine proprietary algorithm, which generate Biovitals Index: - Personal physiology signature data base initialization (at the early stage on the algorithm when the engine learns the patients and builds the personal baseline) - Biovitals Index calculation - Biovitals Analytics engine generates the Biovitals Index which is a time series scalar value from 0 to 1. - The output of BA Engine is stored in a cloud-based database. - The output API queries the databases and gets the output, and the output shall be reviewed by the qualified practitioner via a dashboard.

The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. T3 is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient's status, and - To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner. T3 can display numeric physiologic data captured by other medical devices: - Airway flow, volume and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - Cerebral perfusion pressure - End-tidal CO2 - Heart rate - Heart rate variability - Intracranial pressure - Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) - Premature ventricular counted beats - Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - Pulse Rate - Respiratory rate - Right atrium pressure - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - Umbilical arterial pressure (systolic, diastolic, and mean) It can also display laboratory measurements including arterial and venous blood count, and lactic acid. T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with post-surgical neonatal patients weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.

The Tracking, Trajectory, Trigger (T3) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include: - Customizable display of physiologic parameters over entire patient stay. - Configurable annotation - Web-based visualization that may be used on any standard browser - Minimal IT footprint - Software-only solution no new bedside hardware required - Highly reliable and robust operation. - Auditable data storage. The subject device is a modification of the T3 Software that includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.

The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient's monitored vital signs change from those measured at baseline, which has been derived from measurements previously obtained during routine activities of daily living. The MCI is based on an integrated computation evaluating changes in the parameters and their relationships to each other. The PPA Engine is an adjunct to and is not intended to replace vital signs monitoring. The MCI is intended for daily intermittent, retrospective review by a qualified practitioner. The PPA Engine is intended to provide additional information for use during routine patient monitoring. The MCI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

The PhysIQ Personalized Physiology Analytics Engine ("PPA Engine") is a computerized analysis software program that is designed for detecting change in the relationships among the patient's vital signs throughout dynamic physical activity, based on data input from multi-parameter vital sign monitoring devices. The PPA Engine first "learns" a patient's personalized baseline, defined by the relationship among the vital signs derived from measurements obtained during routine activities of daily living. Once the baseline vital sign relationships are established, it analyzes the subsequent data to assess how the relationships among the vital signs incoming during the monitoring period compare to the established baseline. The PPA Engine can analyze data collected wherever the patient is monitored, reflecting a patient's activities of daily living. The device is intended for monitoring ambulatory patients. The PPA Engine requires vital sign inputs of Heart Rate (HR), Respiration Rate (RR) and Activity (ACT) (body motion). The PPA Engine can accept input from commercial vital sign monitors or combinations of monitors that can provide multivariate observations of these vital signs. The PPA Engine calculates the Multivariate Change Index (MCI), a scalar index between 0 and 1, which represents the likelihood that the relationships among the patient's vital signs are different from those at baseline, which was established during routine activities of daily living. An MCI value closer to zero (0) indicates that the monitored relationships among the vital signs are similar to the learned baseline. An MCI value closer to one (1) indicates that the patient's monitored relationships among the vital signs are likely to be different from the learned baseline. The MCI is also presented as a time series (MCI over time) and it is intended to for retrospective review by the clinician The MCI is not intended to replace standard patient monitoring. Rather, it was designed to supplement standard monitoring of ambulatory patients.