Introduction

The Vocera Engage Medical Device Alarm Notification is manufactured by Vocera Communications, 1950 West Cook Road, Suite 101, Fort Wayne, IN 46818 (1-877-207-3753)

Warning: The Vocera Engage Medical Device Alarm Notification is contraindicated as a primary alarm notification system for medical devices or medical device system alarms.

Warning: All alerts delivered to mobile devices by Vocera Engage Medical Device Alarm Notification are secondary alerts.

Warning: Vocera 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 patient monitoring.

Warning: Do not rely solely on Vocera 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.

CAUTION:

Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

This website contains the Vocera 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.
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 Documentation HTML.

For ease of use, this website replicates the structure described in the FDA guidance document titled Guidance on Medical Device Patient Labeling.