Warnings

The Danger, Warning, Caution, and Note safety messages that are used in this Directions for Use documentation.

Introduction to Warnings

This section of the Directions For Use (DFU) is intended to describe the specific hazard alert information that you should know before using the device.

Safety Message Signal Words

Safety message signal words designate the severity of a potential hazard.

DANGER Safety Message

No danger safety messages apply to this system.

WARNING Safety Message

The following warning safety messages apply to this system.

Warning: Risk of Failure if Dropped or Subjected to Vibration Avoid dropping the appliance. Do not expose the appliance to vibration. Complete all Customer Acceptance Testing after installation to ensure proper functioning of the appliance.
Warning: Alerts will not pop up or play a sound if the device time is more than 10 seconds in the future of the actual time. The badge counter will increase and is displayed in the Notification Tray.
Warning: The Engage Medical Device Alarm Notification is contraindicated as a primary alarm notification system for medical devices or medical device system alarms.
Warning: Setting the notification type to None for iOS devices will preclude Engage Medical Device Alarm Notification from effectively notifying the user of alerts, and could result in patient injury or death.
Warning: All alerts delivered to mobile devices by Engage Medical Device Alarm Notification are secondary alerts.
Warning: Federal law restricts this device to sale by or on he order of a licensed medical practitioner.
Warning: Document all Vocera appliance device settings that were configured during installation of Vocera's Engage Medical Device Alarm Notification software. Modifying, deleting or replacing any Vocera appliance files or changing any of the device settings can result in sub-optimal Engage Medical Device Alarm Notification performance, including inhibition of alert notification delivery, system time settings, alert type, alert volume and wireless network connection.
Warning:
Warning: Turning down or off phone ringer/vibrate will preclude Engage Medical Device Alarm Notification from effectively notifying the user of alerts, and could result in patient injury or death.
Warning: Accuracy – If the data intended to be transmitted is not available or the accuracy of the transmitted data is questionable, the caregiver should access the data from the source device, such as the primary patient monitor for physiological data or the EMR/HIS for patient demographic information. The data provided via the Vocera's Engage Medical Device Alarm Notification device is not intended to be the sole source for patient data and is to be used in conjunction with the data at the patient monitor or central station. The primary patient monitor should always be referenced before making any patient care decisions.
Warning: Engage Medical Device Alarm Notification is dependent upon your facility's ADT solution for patient demographic and location information.
Warning: Caregivers must be trained on proper action instructions for alerts, and hospitals must schedule routine equipment inspection and calibration. If a patient monitor goes into a fail state, it may generate an alarm cancelled message but the alarm actually remains active.
Warning: System configuration must be performed only by qualified personnel who are trained and familiar with the Engage appliance and relevant communication standards, and with local implementation of the medical device aggregator. Improper configuration of Engage adaptors can cause unexpected and unintended behavior of the clinical alert notification service.
Warning: Engage Medical Device Alarm Notification data is designed to manage and notify using a subset of the patient data that is available at the medical device aggregator and related central station displays. Do not rely solely on Engage Medical Device Alarm Notification data for patient monitoring.
Warning: Do not rely solely 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. In these specific examples, Engage Medical Device Alarm Notification may not deliver clinical alert notifications:
Warning: Loss of Functionality/Data Loss – Do not change Vocera system components or configuration without approval by Vocera. Such changes could degrade system performance and affect patient monitoring.
Warning: Only Vocera authorized personnel are allowed to change alert timing delays. A delay can result in harm to the patient, and the facility must sign-off on workflows that include a delay in the initial notification.
Warning: If Vocera is installed on a secure network, the device must be on the same secure network to receive alerts. Be aware that connecting to a network other than the required network, either manually or automatically, will prevent the user from getting alerts.
Warning: TFTP Services Restart Restarting the TFTP Service for a Cisco Communications Manager will cause all of the phones connected to the Communications Manager to failover to a secondary Communications Manager. If there is no secondary Communications Manager available, all of the phones will restart.
Warning: Engage Mobile 5.X will not work properly without XMPP 3.X. Failure to install the correct versions will result in missed alarms and system failures.
Warning: Engage Mobile version 4.X is not compatible with later versions, and the customer facility must have the XMPP version 2.X adapter installed on their appliance.
Warning: Engage Mobile 5.0 or above will not work properly without XMPP 3.0. Failure to install the correct versions will result in missed alarms and system failures.
Warning: If an iOS device is not connected to the network and multiple alert notifications are generated during this time, the device may only receive the most recent alert notification from the Apple Push Notification Service.
Warning: Use of an RTLS integration will selectively deliver patient alarms. Continue to monitor patients at primary patient monitors.

CAUTION Safety Message

The following caution safety messages apply to this system.

CAUTION:
Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
CAUTION:
Accuracy – A user must verify the accuracy of patient demographic information by confirming the transmitted alert data with a second source.
CAUTION:
Automated or manual changes to the time or date settings of the attached medical device (including daylight savings time adjustments) may affect operation of the Engage Medical Device Alarm Notification device, such as loss of patient data history. Refer to the medical device product documentation for detailed information about the effects of time changes.

NOTE Safety Message

The following note safety messages apply to this system.

Note: Always recharge a mobile device when it is not in use and at first notification of low batteries. A device with low batteries will eventually fail as power is depleted.
Note: Engage Mobile is not compatible with the 3D Touch feature available on the iPhone 6s or 6s+ models. Swiping through Engage Mobile with 3D Touch enabled may unexpectedly take the user outside of the application.
Note: Failure to disable the battery saving feature that temporarily turns off Wi-Fi when the Motorola MC40 (MC40-HC) goes to sleep will prevent the user from getting alerts.
Note: Failure to disable the battery saving feature that temporarily turns off Wi-Fi when the Zebra TC51 (TC51-HC) goes to sleep will prevent the user from getting alerts.
Note: A user must log out of their current device before logging into a different device. Failure to do so may cause unintended consequences such as alert notification failure.
Note: The Resynchronize Users and Groups button will require a significant amount of time to process. Pressing this button uploads all user and group information from the LDAP server, which is then read and updated in Vocera.
Note: Disable the Snapshot feature of VMWare. Leaving the Snapshot feature enabled can cause the VM to lose connectivity for an extended period of time. The client should manually take a snapshot of their VM immediately before and after any upgrades.
Note: When the facility uses Rauland-Borg ResponderSync for staff assignment, ResponderSync polling for assignment information may cause an inaccuracy in a Vocera assignment. In a facility where hourly polling takes multiple minutes to complete, it is possible that an assigment made while the system is polling will not be received, resulting in an incorrect assignment until the next poll event updates the assignment information.
Note: Loss of Functionality/Data Loss – Be extremely careful not to assign the same IP address to two different devices on the network. Duplicate IP addresses will cause erratic system communications and data loss.
Note: Loss of Functionality/Data Loss - It is important to limit the number of people in escalation paths and to not use groups as recipients when using OAI hardware. The OAI system has a set maximum number of access points, and will not allow any additional devices to connect when all points are in use. When the OAI network access points are maximized, additional mobile devices do not receive alerts and caregiver action is delayed.
Note: Swiping through Engage Mobile with 3D Touch enabled, a feature available on iPhone 6 models, may unexpectedly take the user outside of the application.
Note: Alerts delivered to mobile devices might be considered primary alarms by caregivers. Continue to remind users that Clinical Alert notification is secondary and always continue to monitor patients at primary patient monitors.
Note: User Interface – Only Vocera personnel are allowed to authorize network changes. Caregiver action may be delayed if unauthorized changes are made to the Vocera appliance network.
Note: Any hospital may include additional options to those described in this Administrator Menu documentation. Depending on the solution, you may have additional optionsThe Resynchronize Users and Groups button will require a significant amount of time to process. Pressing this button uploads all user and group information from the LDAP server, which is then read and updated in Vocera. configured.
Note: Only external devices specifically designed to be connected to the Vocera appliance, or approved by Vocera for use with the Vocera appliance should be connected, as specified in this manual or as otherwise specified by Vocera. External equipment must be connected to the system only by qualified service personnel. Connecting external devices not approved for use with the Vocera appliance may cause loss of function or equipment damage.
Note: Shut down of the Vocera appliance will cause disruption of data flow between the appliance and the medical device aggregator and the supported mobile devices. Notify the affected users relying upon this data flow before shutting down the appliance, or if the appliance shuts down for any reason.
Note: If more than one ADT server exists on the accessible hospital network, intermittent failures may occur. Be sure to allow only one ADT server to operate on the accessible hospital network.
Note: Contact Vocera for information before connecting any devices to the equipment that are not specifically recommended in this manual.
Note: Periodically, and whenever the integrity of the medical device or patient data stream is in doubt, test all functions.
Note: In network configurations or IP address settings are changed; update the Vocera appliance with the new IP address settings. Failure to follow this instruction can cause loss of connectivity with the Vocera appliance.
Note: The Adapter engine backup procedure should be performed at regular intervals and/or whenever any adapter is changed to ensure complete adapter restoration if it should become necessary.
Note: Do not allow mobile devices to act as a Network Time Protocol (NTP) server. Mobile devices can drop communication packets that may cause communication problems resulting from time errors.
Note: The SpectraLink 8000 OAI Gateway is recommended and tested to be used with a TCP/IP connection only.
Note: The SpectraLink 6100 and 6300 Gateway may only be used with an RS-232 connection.
Note: The SpectraLink OAI adaptor supports a maximum of ten messages on the SpectraLink OAI devices. Only the ten most recent messages display on the phone.
Note: Vocera does not support softkey functionality in the SpectraLink OAI 6020 device.
Note: The end user will not be able to receive Vocera alerts on their device if the MAC address is displayed in the Available Devices box. The device's MAC address must be shown in the Controlled Devices box.
Note: The Motorola MC40 handset device has a scan button feature that can be used to populate the 'Domain' field via a QR code.
Note: The bar code reader for the Motorola MC40 will not work with the Engage Mobile application.
Note: The bar code reader for the Zebra TC51 will not work with the Engage Mobile application.
Note: Any air gestures or eye gestures enabled in the Samsung Galaxy S4 device will not work within the Engage Mobile application.
Note: The facility name is added to the unit name when a single instance of Engage supports users from several facilities, each of which may have a unit with the same name. For example, a Cardio unit may exist in General Hospital and Central Hospital. When a single Engage instance supports both facilities, the facility name is prepended to the unit name, such as General Hospital Cardio.
Note: The application will not function as designed if "Don't Allow" is selected at the Use Current Location prompt, or if location services is turned off.
Note: A single character must be entered into the search function for results to begin to appear.
Note: When a user is configured on multiple escalation levels, they will not get an update via XMPP since they are already considered part of the conversation. For example, where a Charge Nurse is assigned to two escalation levels, Primary and Tertiary, this user will only get the Primary alert and no subsequent notifications, including the Tertiary level alert when no other caregivers can accept the alert.
Note: If your facility is using phones with an XMPP integration, you will not have the option to assign a user, assign a default unit, or remove a default unit as these options are managed automatically for XMPP devices.
Note: Users cannot be assigned to XMPP devices using Manage Phones. Users must log into Engage Mobile from the XMPP device, and that login serves the same purpose as assigning the user to the phone.
Note: Users cannot be unassigned from XMPP devices using Manage Phones. Users must log out of Engage Mobile from the XMPP device, and that logout serves the same purpose as unassigning the user from the phone.
Note: Only XMPP phones have a disconnected status. If your facility does not use phones with an XMPP integration, this option will always return no results.
Note: Asterisks are displayed when the system can find no corresponding information for the field.
Note: Three asterisks (***) display in place of the user name in the search results when the device that received the message was not associated with a user at the time of the message delivery.
Note: When the message is sent from a web browser, three asterisks (***) display in place of the phone number in the search results.
Note: Removing the alert will only remove it from the Cisco fixed device, not from any corresponding systems or records.
Note: Not all facilities opt for a full three level escalation path. Some facilities may choose to use one or two levels of assignment for alert notifications.
Note: The Administrator, Charge Nurse, Super User, and End User can track alerts and messages. The End User role can track messages only. Contact a System Administrator for assistance.
Note: The Administrator and Super User can manage message templates and template categories, and unit associations with categories; contact a System Administrator for assistance.
Note: Only the Administrator and Super User roles can manage phones; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can manage user presence states; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can manage the unit's rooms and beds; contact a System Administrator for assistance.
Note: Only the Administrator role can view the Manage Configurations functionality; contact a System Administrator for assistance.
Note: Only an Administrator can manage functional roles in the Administrator Menu; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can view the Manage Locations functionality; contact a System Administrator for assistance.
Note: Only the Administrator can manage user groups; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can manage a user's default unit, title and group; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can manage the Monitor Technician in the system; contact a System Administrator for assistance.
Note: Only the Administrator role can view all configured units in a facility; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can view all patients in the system; contact the System Administrator for assistance if needed.
Note: Only the Administrator role can view the Alarm System Status; contact a System Administrator for assistance.
Note: Only the Administrator role can view the Manage RTLS Locations functionality; contact a System Administrator for assistance.
Note: Only the Charge Nurse / Unit Secretary role can access this workflow to manage phone assignments for other users; contact a System Administrator for assistance if needed.
Note: Only the Charge Nurse/Unit Secretary, Super User, or Administrator role can view the Quick Staff Assignment functionality; contact a System Administrator for assistance.
Note: Only the Charge Nurse/Unit Secretary, Super User, and Administrator default roles can manage unit staff assignments; contact the System Administrator for assistance if needed.
Note: Only the Charge Nurse can access the Assign User Groups functionality. Contact an Administrator for assistance if needed.
Note: Only the End User role can log in or out of a phone using this workflow; contact a System Administrator for assistance.
Note: Use the Unit Staff Assignment workflow for advanced assignments.
Note: Enter a user login that was previously uploaded to the system. Failure to do so will create a user with no associations and alerts cannot be passed to that user.
Note: The system cannot delete a facility if there are units, rooms, or locations assigned to the facility.
Note: You CANNOT delete a unit if there are rooms assigned to it.
Note: You CANNOT delete a room if there are beds assigned to it.
Note: A Room Name is NOT required when creating a room.
Note: When message templates are created, edited, or removed in the system, some end users will not see the changes until they log out and then log back into their device.
Note: Assignments are defined as needed for the facility and are created in the Manage Configurations workflow. Contact an Administrator for assistance.
Note: It is recommended that ALL users have a default unit assigned. Without a default unit, there will be unintended errors.
Note: Engage does not support sending group messages using SpectraLink OAI devices.
Note: Alert message may be truncated causing the alert status to not visible on a SpectraLink OAI device screen. When an alert is accepted or declined, the update message sent to recipients may be too long to fit the screen, however, an audit event is logged with the details.
Note: A user must be connected to wifi to download the Engage Mobile application.
Note: Additional Information For additional information on restarting services, see the Cisco Unified Serviceability Administration Guide for the version of Communications Manager being used.For additional information on uploading files to the TFTP server, see the Cisco Unified Communications Operating System Administration Guide for the version of Communications Manager being used.
Note: Mindray Panorama delivers an alarm only once. As a result, the adapter will process only one alert per Mindray alarm.
Note: An additional Mindray adapter will need to be set up on the appliance for every Mindray Central Network in the facility.
Note: If you want to store the recipient, select the checkbox for Store Message Recipient and enter clinical.to.number in the Recipient field.
Note: The values in the regular expression mappings should be updated based on the messages received from the Mindray monitor and the facility configuration.
Note: The pagers.ini file is one of the files saved to the Emergency Disk. Create an Emergency Disk to save this file.
Note: When a user is configured on multiple escalation levels, they will not get an update via XMPP since they are already considered part of the conversation. For example, where a Charge Nurse is assigned to two escalation levels, Primary and Tertiary, this user will only get the Primary alert and no subsequent notifications, including the Tertiary level alert when no other caregivers can accept the alert.
Note: For each installation, update the regular expressions in the default adapter settings to work with the facility's patient monitor's current software version. See the Regular Expressions (Regex) configuration page for details. Refer to the CEI Alarm Messages document for expected message formats based on the software version.
Note: The SpectraLink 8000 OAI Gateway is recommended and tested to be used with a TCP/IP connection only.
Note: The SpectraLink 6100 and 6300 Gateway may only be used with an RS-232 connection.
Note: When using Cisco 8821 handsets use caution when navigating pages using the Back button. The last page viewed is not refreshed when the Back button is pressed; this may result in content that is outdated.
Note: If the facility uses Mirth CAN channels with the EMDAN version 1.8 solution, the 'extension-solutions-mdan-logrotate' RPM must be installed in order to create necessary permissions for a functional logrotate.
Note: Upgrading a device to the Android 6.0 Marshmallow operating system may create a different device ID in in the registration history. This is an artifact of the new operating system and will not affect your service.
Note: Two or more characters must be entered into the search bar for results to begin to appear. The search will return results from both first and last names, title, and role.
Note: The plus icon on the top right corner of the screen will become gray when presenting an expired conversation.
Note: Some Status icons might not appear in the Status Bar if there are too many icons to display.
Note: When using Cisco 8821 handsets, use caution when navigating pages using the Back button. The last page viewed is not refreshed when the Back button is pressed; this may result in content that is outdated.
Note: Changing the device camera permissions for Engage while logged in as a user will cause the application to crash. When you restart the application, the most recent camera setting you chose will be stored in Engage.
Note: While it is possible to deploy and update the Engage Mobile application on iOS devices via MDM or the Apple App Store, do not deploy devices in an enterprise using both methods. Deploying the Engage Mobile application using both MDM and the Apple App Store will result in APNS messages not being sent to all devices. Use only MDM to deploy and update devices in an enterprise environment.

Conclusion

This concludes the Warnings for the Engage Directions for Use.