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+ACG is a Clinical Decision Support device that only matches data to Hospital-defined protocols to generate Alarms and Advisories. +ACG uses data from multiple sources including medical devices and healthcare information systems. Medical Facilities use their clinical protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility < clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives. lt is not intended to replace clinicians' judgement, but rather to assist clinicians in making timely, informed decisions. +ACG is not intended to be used for secondary monitoring. +ACG Alarms are not intended to be relied upon in deciding to take immediate clinical action. +ACG only works with Talis EMR Products.

Talis EMR software is an Electronic Medical Record intended to support patient care documentation compliant with patient care record and billing requirements. Talis EMR leverages a non-device MDDS to acquire, transmit, store, and display electronic patient information available from multiple electronic sources including other EMRs and medical devices. Talis EMR provides no clinical recommendations, performs no assessment of patient conditions, and uses no proprietary algorithms. Display or access to patient data is not intended to influence the judgement of the healthcare professional user. Talis EMR software functions are either non-device software functions or software functions for which FDA has determined to exercise enforcement discretion. +ACG software is an alarm notification system which may be configured to notify health care professionals when alarm or advisory conditions are identified based on patient data matching the Medical Facility defined alarm or advisory condition criteria. +ACG alarm/advisory notifications are limited to alarm or advisory conditions defined by the Medical Facility. Medical Facilities use their clinical practices, protocols, and policies to define clinically relevant alarms and advisory criteria. Talis then configures Alarms and Advisories within +ACG to be used by the Medical Facility's clinical physicians or appropriate medical staff under the direction of physicians. +ACG is intended to support the Medical Facility's efforts to improve compliance to their patient care protocols and achievement of their quality initiatives. +ACG software only works with Talis EMR software.