The Danger, Warning, Caution, and Note safety messages that are
used in this documentation.
Introduction to Warnings
This section of the Directions For Use
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 indicates an imminently hazardous situation, which, if not avoided,
will result in death or serious injury.
- WARNING indicates a potentially hazardous situation, which, if not avoided,
could result in death or serious injury.
- CAUTION indicates a potentially hazardous situation, which, if not avoided,
will result in minor or moderate injury.
- NOTE indicates an informational message that does not pertain directly to a
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 Vocera 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 Vocera 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 Vocera 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 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 Vocera Engage Medical Device Alarm Notification performance,
including inhibition of alert notification delivery, system time settings, alert type,
alert volume and wireless network connection.
Warning: When a system sending alerts to Engage manages the alerts, that system assumes
the role and responsibilities of alarm manager.
Warning: Turning down or off phone
ringer/vibrate will preclude Vocera 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 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: Vocera 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 Vocera appliance and relevant communication standards, and
with local implementation of the medical device aggregator. Improper configuration of
Vocera adapters can cause unexpected and unintended behavior of the clinical alert
notification service.
Warning: Vocera 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 Vocera Engage Medical Device Alarm Notification data for patient monitoring.
Warning: Do not rely
solely
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. In these specific
examples,
Vocera Engage Medical Device Alarm Notification may not deliver clinical alert
notifications:
- A clinician is not assigned to the location.
- The mobile device is turned off or the battery is depleted.
- The assigned clinician has exited the Unit.
- The assigned clinician is logged out of the Vocera application.
- The mobile device is not communicating with the Vocera appliance.
- The medical device or medical device aggregator is not communicating with
the Vocera appliance.
- The patient monitor is not communicating with the medical device
aggregator.
- The patient is disconnected from the patient monitor.
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
fail-over 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 Vocera 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
assignment 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 options. 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: 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 soft-key functionality on 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 Vocera 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 Vocera
instance supports both facilities, the facility name is pre-pended 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: Vocera 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.
- Facility: value is not received and must be hardcoded. The Implementation
Specialist may configure this.
- Bed Number: mapped to clinical.bed.room.room_number. If the value received
is not consistent with the naming used by the facility, the Implementation
Specialist may hardcode a value such as "1".
- Clinical ID: this is a unique identifier for the alert composed of an
adapter prefix, location, alert type, and alarm time.
- Activity State: value is not received and must be set to ACTIVE for new
alerts.
- Alarm Time: value is not received and must be set to current time for new
alerts.
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 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 Mobile 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 Vocera.
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 Vocera Directions For Use .