The indications for use for the Vocera Communications EMDAN product version 1.10, released January, 2018.
This section of the Directions For Use (DFU) is intended to describe the FDA cleared or approved indications for use for this medical device.
Indications for Use
Vocera Healthcare's Engage Medical Device Alarm Notification is a closed loop communications system that interfaces with health care information systems and medical devices to provide a secondary means of ennunciating and displaying patient alarm text and other information to mobile health care workers that is important to patient care, nursing vigilance and overall hospital operations.
Engage Medical Device Alarm Notification alerts and informs the clinician about critical patient alarms by drawing an identified individual’s attention to a defined patient condition in a timely manner without requiring them to be at or near the bedside medical devices or central station displays. Engage Medical Device Alarm Notification is not intended to replace any part of the patient monitoring system or procedures already existing for the medical devices interfaced with Engage Medical Device Alarm Notification.
Engage Medical Device Alarm Notification is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital and hospital type acute care environments and is not for home use.