Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong
to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States
and/or in other countries.
This manual provides instructions for the Vital Sync mobile application.
Note: Before use, carefully review appropriate sections of this manual and the operator’s manual for
each connected device, applicable accessory instructions for use, and all precautionary information
and specifications.
Note: The app runs on mobile devices using the iOS™* mobile operating system in conjunction with the
Vital Sync virtual patient monitoring platform and informatics manager. To avoid delays in treating
patients or in responding to patient conditions, consult the platform’s reference manual for guidance on
basic software functionality. This includes (but is not limited to) alarm management, patient assignment,
and device monitoring.
1.2 Applicable Version
This manual applies to version 3.0.0 of the Vital Sync mobile application.
Users can view specific information for their installation of the app in the Main Menu view.
1.3 Conventions
Text and terminology conventions used in this manual include the following:
•Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient,
user, or environment.
•Cautions alert users to exercise appropriate care for safe and effective use of the product.
•Notes provide additional guidelines or information.
•Button names, menu options, and field names generally appear in boldface text.
•“Application” and “app” refer to the Vital Sync mobile app, while “platform” refers to the Vital Sync
virtual patient monitoring platform and informatics manager. “Software” refers generally to both the
mobile app and the platform.
•“View” refers to individual app screens. “Screen” refers more generally to the mobile device’s
display.
•“Touch” and “tap” refer to the action activating buttons and menus in the app’s user interface.
"Swipe" refers to the motion used to change from one page to another in a view.
•“Clinician” refers to nurses, physicians, respiratory care professionals and other caregivers who use
the app.
•“Device” refers to medical devices at the patient’s bedside. “Mobile device” refers to the smartphone
used to access the app.
Note: Names of persons and facilities used as examples in this document are fictitious, and are
intended for illustrative and instructional purposes only. Any similarity to actual names of persons or
facilities is coincidental.
1.4 Safety Information
This section contains generally applicable safety information for this product.
1.4.1 Warnings
•Warning: The Vital Sync mobile application is not intended to be used as the sole source of patient
monitoring. Improper configuration of application messages or incorrect patient assignment could
cause delays in treatment or clinical intervention, which could result in patient injury.
7
•Warning: The Vital Sync software is intended to supplement and not to replace any part of the
facility’s monitoring. Do not rely on the Vital Sync software as the sole source of alarms. In order to
assure a timely response to device alarms, a clinician (not necessarily the clinician viewing data in
the platform) must be within visual and/or audible range of the alarming device. In order to provide
medical intervention, a clinician must interact with the device at the bedside.
•Warning: Adjusting a device’s alarm threshold settings or pausing a device’s audible alarm from
within the app will change settings or pause the alarm tone on the device at the bedside.
•Warning: The Vital Sync mobile application is intended only as an adjunct in patient assessment.
It must be used in conjunction with clinical signs and symptoms and periodic patient observations.
•Warning: Always follow the facility’s established patient safety protocols when using the Vital Sync
mobile application.
•Warning: To avoid delayed response to alarms and potential patient injury, do not disable push
notifications for the application.
1.4.2 Cautions
•Caution: Loss of patient privacy may occur if using the software on unsecured or unencrypted
networks. Always adhere to facility patient privacy practices and procedures to ensure security of
patient data on the facility’s network.
•Caution: Push notifications in the app will be delayed for any alarm for which an annunciation delay
is set up in the Vital Sync informatics manager. Users should be aware of annunciation delays set
up for alarms on any monitored device.
•Caution: Ensure that users who will need to use the app’s remote control functionality have
sufficient user rights set up for them in the software. Consult with the Medtronic Solution Delivery
Team for account configuration and setup assistance.
1.4.3 Notes
Note: To prevent unauthorized access to the application, users should always lock the mobile device on
which they are running the app when it is not in use.
Note: After admitting or identifying a patient via the app, confirm that the patient physically present in the
bed is the patient indicated in the app. Also, confirm that the device linked to that patient in the app is
physically present with the patient.
1.5 Obtaining Technical Assistance
1.5.1 Technical Services
For technical information and assistance if unable to correct a problem while using the application,
contact Medtronic or a local Medtronic representative.
Medtronic Technical Services
15 Hampshire Street
Mansfield, MA 02048 USA
1 800 497 4968, or 1 925 463 4635
HIMSupport@Medtronic.com
When calling Medtronic or a local Medtronic representative, provide the application’s version number,
build number, and date of build, shown in the About row in the Main Menu.
8
1.5.2 Related Documents
Before using the app, review this manual and appropriate sections of the reference manual for the
Vital Sync virtual patient monitoring platform and informatics manager. This information is essential for
understanding application functions and information displays.
Also read all precautionary information and specifications for the app and for the platform.
1.6 Warranty Information
The information contained in this document is subject to change without notice. Medtronic makes no
warranty of any kind with regard to this material, including, but not limited to, the implied warranties or
merchantability and fitness for a particular purpose. Medtronic shall not be liable for errors contained
herein or for incidental or consequential damages in connection with the furnishing, performance, or use
of this material.
1.7 Licensing Information
For more details regarding software licenses, refer to the following sections.
1.7.1 Vital Sync and Third Party Software
Licenses obtained from Medtronic for use of Vital Sync software do not include licenses for any third
party software.
Users must obtain their own licenses for the downloading and use of such third party software.
1.7.2 Off-the-Shelf and Open Source Software Disclosure
This section identifies the off-the-shelf (OTS) and open source software that may be separately called,
executed, linked, affiliated, or otherwise utilized by this Vital Sync software product.
Such software is licensed to users subject to the terms and conditions of the separate software license
agreement for such OTS and open source software.
Use of OTS and open source software by users of the Vital Sync mobile application shall be governed
entirely by the terms and conditions of such license.
Table 1. OTS and Open Source Software
Software TitleSoftware DesignatorManufacturer
iOS™*12.0 or later versionsApple™*
Firebase™* Coren/aGoogle™*
Firebase™* Messagingn/aGoogle™*
Charts3.0.5Open source community
IQKeyboardManagerSwift6.5.0Open source community
DropDown2.3.13Open source community
CryptoSwift1.4.0Open source community
NewPopMenu2.1.1Open source community
HandyUIKit1.9.0Open source community
KeychainSwift19.0.0Open source community
SimpleCheckBox2.1.0Open source community
Alamofire5.4.1Open source community
NewRelicAgent6.10.0Open source community
9
1.8 HIPAA Disclaimer
The Vital Sync mobile application is a software application used in conjunction with electronic medical
devices within the customer’s secure health information system. Healthcare providers using the
software are expected to take appropriate security measures to protect the confidentiality of all data
created, stored or transmitted on their systems.
Although the Vital Sync mobile application and Vital Sync virtual patient monitoring platform and
informatics manager contain certain features to assist users in the users’ steps to protect their data,
Medtronic cannot provide any assurance that the user’s use of the software will comply with HIPAA
regulations or be otherwise in compliance with the customer’s obligations as a covered entity.
1.9 Statement Regarding FDA Clearance of Features
The remote control feature in the Vital Sync software has not been cleared by the United States Food
and Drug Administration. The feature is being introduced using FDA’s Enforcement Policy for
Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised), updated October
2020.
10
2 Product Overview
2.1 Overview
This chapter provides an overall description of the functionality of the Vital Sync mobile application.
2.2 Intended Use
The Vital Sync Mobile App is intended to be used with the Vital Sync Informatics Manager (IM) and
Virtual Patient Monitoring Platform (VPMP).
The Vital Sync Mobile App provides remote viewing of patient data, physiologic data, waveforms, alarm
information, and PUSH alerts routed through the Vital Sync Informatics Manager from supported
devices.
The Vital Sync Mobile App provides the user interface to support the Vital Sync IM and VPMP remote
control functionality. (Remote control functionality has not been cleared by the FDA and is being
released per FDA’s Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to
Support Patient Monitoring During the Coronavirus Disease (COVID-19) Public Health
Emergency (Revised), updated October 2020.)
The Vital Sync Mobile App is intended to be used by healthcare professionals in a hospital or
hospital-type facility.
Warning: The Vital Sync Mobile App and Vital Sync Informatics Manager and Virtual Patient Monitoring
Platform are notification systems and are not replacements for direct patient observation, patient
assessment, or clinical judgment.
2.3 Contraindications
None.
2.4 Application Overview
The app is designed to allow users to access data from medical devices at the patient’s bedside via a
mobile device running the iOS™* mobile operating system.
Users access data and perform other available functions in views within the app, which works in
conjunction with version 3.0 of the Vital Sync virtual patient monitoring platform and informatics
manager.
2.4.1 Basic Functions
Within the app, users can see patient data from supported devices, modify their patient assignments,
and see and be notified of device alarms. Users can also link and unlink devices and admit and manually
discharge patients in the platform via the app.
Selected users can change certain settings or pause the audible alarm on supported devices. See
Each user is identified in the app by username and password, and enters these to log into the app. Users
who are set up in the Vital Sync virtual patient monitoring platform as clinicians or supervisors are able
to log in and use the app.
Available functionality is the same in the app for all users, regardless of their user role in the platform,
except for device remote control functions, which require additional configuration for specific users.
Consult with the Medtronic Solution Delivery team for assistance.
11
2.5 User Interface Symbols
The software makes use of icons and symbols to denote user functions and to show data from patients
and devices. These are defined in the tables in this section.
Table 2. App Navigation Symbols and Definitions
IconDescriptionDefinition/Location
Active Alarms viewButton to access the Active Alarms view.
Appears in the button bar; turns white when tapped to select
the Active Alarms view.
Assigned Patients viewButton to access the Assigned Patients view.
Appears in the button bar; turns white when tapped to select
the Assigned Patients view.
Patient Management viewButton to access the Patient Management view.
Appears in the button bar; turns white when tapped to select
the Patient Management view.
Main Menu viewButton to access the additional function menu.
Appears in the button bar; turns white when tapped to select
the Main Menu view.
Additional function menuButton to access a pop-up menu showing additional func-
tions. Appears on the right side of the identifier panel in the
Device Detail view.
Drop-down menuButton to access a drop-down menu showing options avail-
able for selection. Appears in the information panel in the
Device Detail view, and in one or more fields in the Patient
Management, Admit Patient, Link New Device, and Unlink
views.
Login Settings viewButton to access application login settings.
Appears in the upper right corner of the login view.
Page indicatorAppears near the bottom of the screen if multiple pages are
available in a view. The white dot indicates which page is
currently selected.
Additional informationButton to show more detailed information.
Appears on assignment tiles in the Patient Management
view; changes to downward-pointing when tapped to show
assignment detail.
Exit viewButton to exit the current view and return to the previous view.
Appears in the lower left corner of the Device Detail, Diagnostics, and Privacy views.
New admissionButton to access the Admit Patient view.
Appears in the lower left corner of the Patient Management
view.
RefreshButton to refresh the list of available devices.
Appears in the Admit Patient and Update Patient views, next
to the Device Category field.
12
Table 2. App Navigation Symbols and Definitions (continued)
IconDescriptionDefinition/Location
SearchButton to search for an existing patient ID in the platform.
Appears in the Admit Patient and Update Patient views, next
to the Patient ID field.
View PINButton to toggle view of data entered in the field when chang-
ing the PIN.
Appears next to fields in the Update PIN view; changes to
“opened eye” when tapped to unmask field entry.
Table 3. Alarm and Status Symbols and Definitions
IconDescriptionDefinition/Location
High priority alarmA high priority alarm is active on one of a patient’s devices, or
on the currently viewed device.
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen in the Device Detail view.
Medium priority alarmA medium priority alarm is active on one of a patient’s devi-
ces, or on the currently viewed device
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen in the Device Detail view.
Low priority alarmA low priority alarm is active on one of a patient’s devices, or
on the currently viewed device
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen in the Device Detail view.
Reset alarmA reset alarm is active on one of a patient’s devices, or on the
currently viewed device
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen in the Device Detail view.
NotificationA notification is active on one of a patient’s devices, or on the
currently viewed device
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen in the Device Detail view.
Disconnected capnography
monitor
Disconnected pulse oximeter
The indicated device is currently not communicating with the
platform.
Appears on bed tiles in the Assigned Patients view, and at
the top of the screen and on the device information page in
the Device Detail view.
Disconnected ventilator
Pause device alarmButton to pause the audible alarm tone on supported bed-
side devices. Appears on the right side of the Device Detail
view’s identifier panel (if available for the alarming device);
turns off-white when tapped to pause the device alarm.
Null valueNo data is available or no data is reported for a parameter.
13
Table 3. Alarm and Status Symbols and Definitions (continued)
IconDescriptionDefinition/Location
Appears next to parameter names in the Assigned Patients
and Device Detail views.
Unassigned patientNo users have this patient assigned to them as a primary or
secondary assignment.
Appears next to names of affected patients in the Patient
Management view.
2.6 Devices Supported
The current release of the app supports the following devices:
•Puritan Bennett 980 ventilator
•Puritan Bennett 840 ventilator
•Nellcor bedside respiratory patient monitoring system (model number PM1000N)
•Oridion Capnostream 20 capnography monitor
•Oridion Capnostream 35 portable bedside monitor
The current release of the app supports additional remote control functionality for the following device:
•Oridion Capnostream 35 portable bedside monitor
Selected users can remotely adjust certain alarm thresholds and pause the device’s audible alarm tone
directly from the app. See Section 4.5.7, Remote Setting Changes, page 33 and Section 5.4, PauseBedside Alarms, page 53.
14
3 Installation and Access
3.1 Overview
This chapter describes installing and running the Vital Sync mobile application.
3.2 Requirements
The Vital Sync mobile app requires a device running the iOS™* mobile operating system (version 12.0
or later).
The app also requires an existing installation of the Vital Sync virtual patient monitoring platform and
informatics manager (version 3.0) from which to receive data.
3.3 Installation
3.3.1 Installing the App
To install the application:
1. In the App Store™*, search for “Vital Sync Mobile App”. The listing for the app will appear, with the
following icon shown at upper left in the listing:
2. Tap the download button, then follow prompts on the mobile device for download and installation.
3.3.2 Upgrade Path
Users of version 2.0.0 or version 2.1.0 of the app can upgrade directly to version 3.0.0.
3.4 Initial Setup
To set up the app and access it for the first time:
1. From the mobile device screen, tap the Vital Sync app icon, or, if still in the app’s entry in the App
Store™*, tap the RUN button.
2. Set basic app permissions, as follows:
a. At the prompt asking for permission for the app to access the mobile device’s camera, tap
OK to approve.
b. At the prompt asking for permission for the app to send push notifications to the mobile
device, tap Allow to approve.
Note: Permissions can be adjusted from the mobile device’s settings screen for the app.
See Section 4.9, Additional Settings, page 48.
After setting permissions, the Login Settings view will appear.
15
Figure 1. Login Settings View
3. Set up server URL information for the Vital Sync platform server to be used with the app, as follows:
a. If using a QR code that is encoded with the platform server information, center the code in
the viewfinder on the screen until the device’s camera captures it.
Note: Obtain the QR code or platform server URL (provided by the Medtronic Solution
Delivery Team) from appropriate facility personnel.
b. If entering a URL for the platform server, tap the field below the camera image, enter the URL
in the field, then tap SAVE to continue.
4. The login fields will appear.
16
Figure 2. Login Fields
5. USER NAME—Enter the username assigned in the platform.
6. PASSWORD—Enter the platform login password.
7. Tap LOGIN to continue. The privacy statement will appear.
8. After reviewing the privacy statement, tap ACCEPT to continue, or DECLINE to exit the
application.
After accepting the privacy statement, the Login with PIN fields will appear.
17
Figure 3. Login with PIN Fields
9. PIN—If desired, enter a four-digit to six-digit personal identification number (PIN) to use instead
of the normal login password for future logins, then tap SET PIN to save this number.
If not setting a PIN, tap CONTINUE.
Note: If a PIN is not set, these fields will appear on each subsequent login. To stop this, tap the Don’t
Ask Me Again check box to check it.
The Assigned Patients view will appear.
Note: To ensure push notifications are received on the mobile device, do the following immediately after
signing into the app for the first time:
1. Tap the Main Menu button (rightmost on the button bar) to access the Main Menu view.
2. Log out of the app.
3. Return to the mobile device’s home screen.
4. From the home screen, close the app.
5. Open the app again.
6. Close the app again from the mobile device’s home screen.
7. Open the app again, then sign in.
Note: If push notifications are not being received, toggle notifications and background data refresh off,
then back on in the app settings. See Section 4.9, Additional Settings, page 48.
Refer to subsequent chapters for operation and functionality descriptions.
18
3.5 Running the App
To run the app after initial setup:
1. Tap the Vital Sync app icon on the mobile device screen.
2. USER NAME—Enter the username assigned in the platform.
3. If a login PIN is set up, enter it in the PIN field. If a login PIN is not set up, enter the platform login
password in the PASSWORD field.
Note: The login password can always be used even after setting up a PIN.
4. Tap LOGIN.
The Assigned Patients view will appear.
For details on using the app, see Chapter 4.
19
20
Loading...
+ 44 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.