Vital Sync™
Mobile Application
Reference Manual
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.
Capnostream™, Nellcor™, Puritan Bennett™, Vital Sync™
U.S. patents: www.medtronic.com/patents
Symbols
Federal law restricts this device to sale by or on the order of a physician
Consult instructions for use
Manufacturer
3
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.2 Applicable Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.5 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.7 Licensing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.8 HIPAA Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.9 Statement Regarding FDA Clearance of Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.4 Application Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.5 User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.6 Devices Supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3 Installation and Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.2 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.4 Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.5 Running the App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2 Alarms and Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.3 Navigation and Basic User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.4 Assigned Patients View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.5 Device Detail View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.6 Active Alarms View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.7 Patient Management View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.8 Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.9 Additional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
5 Alarms and Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.2 Summary of Event Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.3 Clear Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.4 Pause Bedside Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.5 View Alarm and Notication Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.6 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.7 Alarm Behavior in the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4
Figures
Figure 1. Login Settings View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Figure 2. Login Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Figure 3. Login with PIN Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figure 4. App Layout and Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Figure 5. App Layout and Navigation (menus) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Figure 6. Assigned Patients View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Figure 7. Bed Tile Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Figure 8. Device Detail View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Figure 9. Information Panel (trend page) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Figure 10. Information Panel (waveform page) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Figure 11. Information Panel (waveform page; ventilator waveform) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Figure 12. Information Panel (device page) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Figure 13. Trend Timeframe Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Figure 14. Trend Information in Landscape Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Figure 15. Available Parameter List (Second Trend button) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Figure 16. Information Panel (trend page with two trends shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Figure 17. Information Panel (trend page with specic data point shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Figure 18. Link New Device View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Figure 19. Link Device View (designated area selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Figure 20. Unlink Device View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Figure 21. Update Patient View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Figure 22. Information Panel (threshold settings) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Figure 23. Active Alarms View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Figure 24. Patient Management View (initial access) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Figure 25. Admit Patient View (initial access) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Figure 26. Admit Patient View (area selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Figure 27. Admit Patient View (bed selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Figure 28. Admit Patient View (patient ID selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Figure 29. Admit Patient View (patient information) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Figure 30. Admit Patient View (device and assignment selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Figure 31. Admit Patient View (designated area selection) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Figure 32. Patient Management View (area drop-down menu) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Figure 33. Patient Management View (assignment tiles) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Figure 34. Patient Management View (assignments shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Figure 35. Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Figure 36. Update PIN View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Figure 37. Diagnostics View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Figure 38. Mobile Device Notication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Figure 39. Lock Screen with Push Notications (screen locked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Figure 40. Lock Screen with Push Notications (screen unlocked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5
Figure 41. Tile Detail (alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Figure 42. Tile Detail (notication shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Figure 43. Active Alarms View (all event types shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Figure 44. Assigned Patients View (events shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Figure 45. Device Detail View (active alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Figure 46. Device Detail View (disconnected device shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Tables
Table 1. OTS and Open Source Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Table 2. App Navigation Symbols and Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Table 3. Alarm and Status Symbols and Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Table 4. Visual Alarm and Notication Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Table 5. Alarm Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6
1 Introduction
1.1 Overview
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 specications.
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.
Note: The v3.0 platform reference manual contains platform functionality descriptions relevant to this release of
the app.
1.2 Applicable Version
This manual applies to version 3.0.1 of the Vital Sync mobile application.
Users can view specic 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 eective use of the product.
• Notes provide additional guidelines or information.
•
Button names, menu options, and eld names generally appear in
• “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 ctitious, and are intended for
illustrative and instructional purposes only. Any similarity to actual names of persons or facilities is coincidental.
boldface
text.
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 conguration 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 notications
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:
in the Vital Sync informatics manager. Users should be aware of annunciation delays set up for alarms on any
monitored device.
•
Caution:
rights set up for them in the software. Consult with the Medtronic Solution Delivery Team for account
conguration and setup assistance.
1.4.3 Notes
Note:
they are running the app when it is not in use.
Note:
is the patient indicated in the app. Also, conrm that the device linked to that patient in the app is physically
present with the patient.
To prevent unauthorized access to the application, users should always lock the mobile device on which
After admitting or identifying a patient via the app, conrm that the patient physically present in the bed
Push notications in the app will be delayed for any alarm for which an annunciation delay is set up
Ensure that users who will need to use the app’s remote control functionality have sucient user
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
Manseld, 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 specications for the app and for the platform.
Note: The v3.0 platform reference manual contains platform functionality descriptions relevant to this release of
the app.
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
tness 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 O-the-Shelf and Open Source Software Disclosure
This section identies the o-the-shelf (OTS) and open source software that may be separately called, executed,
linked, aliated, 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 Title Software Designator Manufacturer
iOS™* 12.0 or later versions Apple™*
Firebase™* Core n/a Google™*
Firebase™* Messaging n/a Google™*
Charts 3.0.5 Open source community
IQKeyboardManagerSwift 6.5.0 Open source community
DropDown 2.3.13 Open source community
CryptoSwift 1.4.0 Open source community
NewPopMenu 2.1.1 Open source community
HandyUIKit 1.9.0 Open source community
KeychainSwift 19.0.0 Open source community
SimpleCheckBox 2.1.0 Open source community
Alamore 5.4.1 Open source community
9
Table 1. OTS and Open Source Software (continued)
Software Title Software Designator Manufacturer
NewRelicAgent 6.10.0 Open source community
RSSelectionMenu 7.1.3 Open source community
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 condentiality 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
Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency (Revised)
, updated October 2020.
Enforcement Policy for Non-Invasive Remote
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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 notication 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 notied 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 Section 4.5.7,
Remote Setting Changes, page 34 and Section 5.4, Pause Bedside Alarms, page 55.
2.4.2 User Roles
Each user is identied 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 conguration for specic 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 dened in the tables in this section.
Table 2. App Navigation Symbols and Denitions
Icon Description Denition/Location
Active Alarms view Button to access the Active Alarms view.
Appears in the button bar; turns white when tapped to select the
Active Alarms view.
Assigned Patients view Button to access the Assigned Patients view.
Appears in the button bar; turns white when tapped to select the
Assigned Patients view.
Patient Management view Button to access the Patient Management view.
Appears in the button bar; turns white when tapped to select the
Patient Management view.
Main Menu view Button to access the additional function menu.
Appears in the button bar; turns white when tapped to select the
Main Menu view.
Additional function menu Button to access a pop-up menu showing additional functions.
Appears on the right side of the identier panel in the Device
Detail view.
Drop-down menu Button to access a drop-down menu showing options available
for selection.
Appears in the information panel in the Device Detail view, and
in one or more elds in the Patient Management, Admit Patient,
Link New Device, and Unlink views.
Login Settings view Button to access application login settings.
Appears in the upper right corner of the login view.
Page indicator Appears near the bottom of the screen if multiple pages are
available in a view. The white dot indicates which page is currently
selected.
Additional information Button to show more detailed information.
Appears on assignment tiles in the Patient Management view;
changes to downward-pointing when tapped to show assign‐
ment detail.
Exit view Button 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.
Check box
Control to access the Designated Areas eld.
Appears in the Admit Patient and Link New Device views just
before the device assignment elds.
12
Table 2. App Navigation Symbols and Denitions (continued)
Icon Description Denition/Location
New admission Button to access the Admit Patient view.
Appears in the lower left corner of the Patient Management view.
Refresh Button to refresh the list of available devices.
Appears in the Admit Patient and Update Patient views, next to
the Device Category eld.
Search Button to search for an existing patient ID in the platform, or eld
to search for a designated area for devices.
Appears in the Admit Patient and Update Patient views, next to the
Patient ID eld. Also appears in the Admit Patient and Link New
Devices views at the top of the Designated Areas drop-down list.
View PIN Button to toggle view of data entered in the eld when changing
the PIN.
Appears next to elds in the Update PIN view; changes to “opened
eye” when tapped to unmask eld entry.
Table 3. Alarm and Status Symbols and Denitions
Icon Description Denition/Location
High priority alarm A 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 alarm A medium 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.
Low priority alarm A 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 alarm A 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.
Notication A notication 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.
13
Table 3. Alarm and Status Symbols and Denitions (continued)
Icon Description Denition/Location
Disconnected capnography
monitor
Disconnected pulse oximeter
Disconnected ventilator
Pause device alarm Button to pause the audible alarm tone on supported bedside
Null value No data is available or no data is reported for a parameter.
Unassigned patient No users have this patient assigned to them as a primary or
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.
devices. Appears on the right side of the Device Detail view’s iden‐
tier panel (if available for the alarming device); turns o-white
when tapped to pause the device alarm.
Appears next to parameter names in the Assigned Patients and
Device Detail views.
secondary assignment.
Appears next to names of aected patients in the Patient Man‐
agement 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 34 and Section 5.4, Pause Bedside Alarms, page 55.
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, version 2.1.0, or version 3.0.0 of the app can upgrade directly to version 3.0.1.
3.4 Initial Setup
To set up the app and access it for the rst 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 notications 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 50.
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
viewnder 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 eld below the camera image, enter the URL in the
eld, then tap SAVE to continue.
4. The login elds 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 elds will appear.
17
Figure 3. Login with PIN Fields
9.
PIN—If desired, enter a four-digit to six-digit personal identication 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 elds 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 notications are received on the mobile device, do the following immediately after signing
into the app for the rst 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 notications are not being received, toggle notications and background data refresh o, then back
on in the app settings. See Section 4.9, Additional Settings, page 50.
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 eld. If a login PIN is not set up, enter the platform login password
in the PASSWORD eld.
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.
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