The Engage Medical Device Alarm Notification is manufactured by Vocera
Communications, 1950 West Cook Road, Suite 101, Fort Wayne, IN 46818
The Engage Medical Device Alarm
Notification is contraindicated as a primary alarm notification system for
medical devices or medical device system alarms.
delivered to mobile devices by Engage Medical Device Alarm Notification are
Warning: Engage Medical Device Alarm Notification
data is designed to manage and notify using a subset of the patient data that is
available from the medical device data aggregator and related central station
displays. Do not solely use Engage Medical Device Alarm Notification data for
Warning: Do not rely solely on Engage Medical
Device Alarm Notification to indicate medical device alerts. Always continue to
monitor patients at primary patient monitors and central station (if applicable)
and respond to patient monitor equipment alerts.
restricts this device to sale by or on the order of a licensed medical
This website contains the Engage Medical Device Alarm
Notification Directions for Use (DFU) documentation. The DFU information is provided
to assist users to understand the expectations and limitations of the product, and
to use the service effectively in performing their responsibilities. You can access
the following information in this website:
- Description Information: Brief description of the device, intended
use and expectations, contraindications, risks and benefits, etc.
- Approved Adapters: Supported integrated adapters, subdivided by
- Warnings: List of safety warnings, cautions, and notes
- Operation Information: Device checkout, operation, monitoring,
cleaning, disposal, etc.
- User Assistance: User support details including levels of support,
levels of severity, contact information, hours of coverage
This DFU documentation is presented electronically. Navigate to details
using the menu, or the tabs at the top of the page. Simply click the PDF icon on
any page to produce a printable version.
Site-wide search is available at
the bottom of the navigation menu. Select All Documentation PDF in the
left menu to view a PDF of the website. Note that this PDF takes several minutes
to generate. You can also view the entire site structure by selecting All
For ease of use, this website replicates the
structure described in the FDA guidance document titled Guidance on Medical Device Patient