|Introduction / Description|
This page describes what to expect with use of the Vocera Communications EMDAN product.
This section of the Directions For Use (DFU) is intended to describe what to expect before, during, and after the use of the device.
Expectations of the Device
Vocera Communications Engage Medical Device Alarm Notification is intended as a secondary alarm notification system where alarm notifications are received from medical devices and automatically dispatched to the responsible caregiver. Users may expect this solution to perform in a safe and effective manner when it is used and maintained in ways described in these directions for use. These user and customer responsibilities are divided between overall system specifications, configuration and performance that must be maintained continuously, and user operation of the system that occurs on a shift by shift basis.
The proper operation of Vocera Engage Medical Device Alarm Notification is dependent on meeting and maintaining basic system configuration and operating specifications that are of an ongoing nature, and are often the responsibility of Clinical Engineering and/or IT. The installation process of Vocera Engage Medical Device Alarm Notification ensures that these configuration and specifications requirements are met upon installation. User acceptance testing ensures that Vocera Engage Medical Device Alarm Notification is configured properly, and that the supporting IT infrastructure (servers, computers and networks) are operating at levels specified for safe and effective operation.
After installation and end user acceptance of the system, responsibility for maintaining system configurations and specifications becomes the responsibility of the customer. Other than the changes entailed with daily use, any time a change is made in Vocera Engage Medical Device Alarm Notification or related subsystems (medical devices, nurse-carried mobile devices, appliance/server, computers, wired and wireless networks) the user acceptance test should be repeated to ensure continued safe and effective operation. These changes include:
The configuration and specifications requirements for subsystems may be found in Vocera Engage Medical Device Alarm Notification installation guide. Any questions about the potential impact of changes to systems may be directed to Vocera Communications Customer Support.
The proper use of Vocera Engage Medical Device Alarm Notification is the responsibility of users and the system administrator(s). End user activities revolve around staff shifts. At the beginning of a shift, users must follow the Operating Information Checkout procedures. These procedures include:
During the shift, users are expected to respond to alarms through their mobile devices as described in these directions for use.