Medtronic VSMASW03 Operator's Manual

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

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 Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Notication Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

5.6 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

5.7 Alarm Behavior in the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

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 specic 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 Notication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Figure 39. Lock Screen with Push Notications (screen locked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 40. Lock Screen with Push Notications (screen unlocked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 41. Tile Detail (alarm shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 42. Tile Detail (notication 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 Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Table 3. Alarm and Status Symbols and Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Table 4. Visual Alarm and Notication Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Table 5. Alarm Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

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 specications.

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 specic 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 eective 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 conguration of application messages or incorrect patient assignment could cause delays in treatment or clinical intervention, which could result in patient injury.

•

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 notications 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 conguration 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, conrm 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, conrm that the patient physically present in the bed

Push notications 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 sucient 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

Manseld, 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.

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 specications 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 identies the o-the-shelf (OTS) and open source software that may be separately called, executed, linked, aliated, 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 Alamore 5.4.1 Open source community

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 condentiality 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

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 notication 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 notied 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 identied 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 conguration for specic users. Consult with the Medtronic Solution Delivery team for assistance.

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 dened in the tables in this section.

Table 2. App Navigation Symbols and Denitions

Icon Description Denition/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 identier 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.

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.

Table 2. App Navigation Symbols and Denitions (continued)

Icon Description Denition/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 Denitions

Icon Description Denition/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.

Notication A notication 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.

Table 3. Alarm and Status Symbols and Denitions (continued)

Icon Description Denition/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‐ tier 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 aected 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.

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:

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 notications 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.

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

viewnder 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.

Figure 2. Login Fields

USER NAME—Enter the username assigned in the platform.

PASSWORD—Enter the platform login password.

Tap LOGIN to continue. The privacy statement will appear.

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.

Figure 3. Login with PIN Fields

PIN—If desired, enter a four-digit to six-digit personal identication 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 notications 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 notications are not being received, toggle notications 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.

3.5 Running the App

To run the app after initial setup:

1. Tap the Vital Sync app icon on the mobile device screen.

USER NAME—Enter the username assigned in the platform.

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.

Tap LOGIN.

The Assigned Patients view will appear.

For details on using the app, see Chapter 4.

4 Operation

4.1 Overview

This chapter describes the operation of the Vital Sync mobile application.

4.2 Alarms and Notications

The Vital Sync mobile application reports alarms and notications (generally referred to as events) from linked devices in multiple views within the app. Event types and priority are denoted using color, symbols, or both.

For details on events and event indicators, see

4.3 Navigation and Basic User Interface

Figure 4. App Layout and Navigation

Section 4.2, Alarms and Notications, page 21

1 Button Bar

2 Page indicator

Users access views within the app via the button bar. Within views, if multiple pages are available, swiping left or right moves to adjacent pages in the view. Exit from detail views by tapping the leftward-pointing arrow at bottom left.

Figure 5. App Layout and Navigation (menus)

1 Drop-down menu

2 Pop-up menu

Users access certain program functions via menus. Open menus in the app by tapping buttons with a downward-pointing caret (for a drop-down menu) or with a vertical stack of dots (for a pop-up menu).

Note: The app is generally best used in portrait mode, except for the second trend view (described in Section 4.5.5.3, View a Second Trend, page 29), which requires landscape mode to access.

Note: Screen captures in this manual are simulated and representative. Actual screens may vary slightly from those shown here.

4.4 Assigned Patients View

The Assigned Patients view is the rst view that appears when running the app. To access the view from elsewhere in the app, tap the Assigned Patients view button (second from left on the button bar).

Figure 6. Assigned Patients View

1 User’s name

2 Assignment type

3 Bed tile (with alarm)

4 Bed tile (with notication)

5 Bed tile (no events active)

Patients appear in the view sorted by assignment type, with primary assignments listed rst.

Note:

Supervisory users can only see a list of their own assigned patients in this view.

4.4.1 Available Tasks

Users can perform the following tasks in or from this view:

• See summary information for all their assigned patients

• Access the Device Detail view for any one of their assigned patients

4.4.2 Bed Tile Information

Bed tiles show patient information and data from linked devices. Tiles are sorted by type of patient assignment (primary, secondary, or monitoring only).

If alarms or notications are active, the bed tile will show a message and will change color to indicate the priority of the event.

Figure 7. Bed Tile Detail

1 Bed number

2 Patient name

3 Device parameters

4 Event icon

5 Message

Note: The event icon shown and the color of the tile outline and message area depend on the event type (alarm or notication) and priority (high, medium, low, or informational).

Note: If multiple events are active for a patient, the icon and message for the event with the highest priority will appear on the tile.

This release of the software allows the following standard parameters to appear on bed tiles:

•

Pulse oximeters

•

Capnography monitors

—Blood oxygen saturation (SpO2) and pulse rate (PR)

—Blood oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), end tidal

carbon dioxide level (ETCO2), and integrated pulmonary index (IPI) value

•

Ventilators

respiratory rate (f

—Peak inspiratory circuit pressure (P

), and exhaled tidal volume (VTE)

TOT

), positive end expiratory pressure (PEEP), total

PEAK

Not all devices may measure all parameters listed here, and some communication protocols limit the types of data reported to the Vital Sync software. If not measured or reported, the parameter will not appear on the tile.

4.4.3 Bed Tile Colors

If a device linked with a patient has an active alarm or notication, a colored border will appear around the tile, and a message area with the same background color will also appear at the bottom of the tile.

•

Yellow

—Indicates at least one low-priority or medium-priority alarm is active on at least one device linked

to the patient in this bed

•

—Indicates at least one high-priority alarm is active on at least one device linked to the patient in this bed

Red

—Indicates at least one notication is active on at least one device linked to the patient in this bed

Blue

If a device parameter shown on the tile is causing a device alarm, that parameter will change color as well. If a device becomes disconnected, an icon indicating its device type (pulse oximeter, capnography monitor, or ventilator) will appear on the bed tile.

•

Note: If multiple alarms or notications are active, the alarm or notication with the highest priority determines the color shown on the tile.

•

Note: The same color is used for medium-priority and low-priority alarms. The alarm icon in the message area denotes the specic alarm priority.

•

Note: The colors indicating alarms and notications on the bed tile also appear in the Device Detail view.

4.5 Device Detail View

To access the Device Detail view, tap or swipe left from the desired bed tile in either the Assigned Patients view or the Active Alarms view.

Figure 8. Device Detail View

1 Settings panel

2 Selected parameter

3 Parameter panel

4 Information panel (trend view shown)

5 Identier panel

If alarms or notications are active on the device, the Device Detail view also shows information about these events. See Chapter 5 for more details.

To exit the Device Detail view at any time and return to the Assigned Patients view, tap the leftward-pointing arrow in the lower left corner of the view.

4.5.1 Available Tasks

Users can perform the following tasks in or from this view:

• See all device parameters, including those not shown on the device tile

• See trend information for any device parameter (or pair of parameters)

• See waveforms for certain device parameters

• See device identiers

• Link an available device to the patient

• Unlink the device currently shown in the app from the patient

• Update information for the patient

• Change certain settings on devices that support remote control functionality

• Manually discharge a patient in the Vital Sync platform

4.5.2 Parameter Panel

The parameter panel is in the upper half of the Device Detail view. This panel shows all reported parameters for the device.

When opening the Device Detail view, the parameter initially selected (indicated by a white border around the parameter) will either be the rst parameter listed, or the parameter with the highest-priority active alarm. More information for the selected parameter is shown in the information panel.

To select a dierent parameter, simply tap it.

4.5.3 Settings Panel

If the patient is linked with a ventilator, the ventilator settings will appear at the top of the Device Detail view, above the parameter panel.

Note: For ventilators, the app shows settings and parameters that are appropriate to the selected ventilation type and mode.

4.5.4 Information Panel

The information panel is in the lower half of the Device Detail view. This panel has pages showing additional information for selected parameters, as well as device identiers.

4.5.4.1 Trend Page

Trending information for any parameter is available on the trend page. This is the default page shown in the information panel when opening the Device Detail view.

Figure 9. Information Panel (trend page)

The trend page shows trend information for the currently selected parameter, as well as upper and lower alarm limits (if set). For more information on trend functions, see Section 4.5.5, Trend Functions, page 28.

4.5.4.2 Waveform Page

Waveforms for certain parameters are available on the waveform page. To view the waveform page, swipe left from the trend page.

Figure 10. Information Panel (waveform page)

Figure 11. Information Panel (waveform page; ventilator waveform)

The waveform will trace from left to right on the page, then refresh itself from left to right.

4.5.4.3 Device Page

Device identiers are available on the device page. To view the device page, swipe left from the trend page (for parameters without waveforms) or from the waveform page.

Figure 12. Information Panel (device page)

The device page shows the serial number and device type for the device from which the parameter currently selected in the parameter panel is reported.

4.5.5 Trend Functions

Users can change the timeframe for trend data, view trends in landscape mode, and view trends for two parameters at once. Details follow.

4.5.5.1 Change the Trend Timeframe

Trend information shown in the app is for the past 4 hours by default for ventilator parameters, and for the past 2 hours by default for parameters from other devices.

To select a dierent timeframe for trend data:

1. Tap the drop-down menu at top right in the information panel to open it. Figure 13. Trend Timeframe Menu

2. Tap the desired timeframe to select it. The trend graph will refresh.

4.5.5.2 View Trends in Landscape Mode

If desired, view trend information in landscape mode by turning the mobile device 90 degrees to either the left or right. The information panel will turn and expand to ll the entire screen.

Figure 14. Trend Information in Landscape Mode

4.5.5.3 View a Second Trend

Users can view trend information for two parameters at the same time.

To view two trends at once:

View trend information in landscape mode. This allows access to the Second Trend button (at top right).

Second Trend—Tap to access the list of available parameters. Figure 15. Available Parameter List (Second Trend button)

3. Tap the desired parameter to show along with the currently selected parameter. The trend graph will refresh, with information for the second parameter shown in yellow. The vertical axis for the second parameter will also appear, shown at the right of the trend data.

Figure 16. Information Panel (trend page with two trends shown)

Note: The second trend will continue to be shown on the information panel even if the mobile device is turned vertically and the screen reverts to portrait mode.

To remove the second trend from the graph, either repeat the procedure in this section and select None, or tap a dierent parameter in the parameter panel to select it.

4.5.5.4 View a Specic Data Point

To see more detail about a specic point on the trend graph, tap on the desired point.

Figure 17. Information Panel (trend page with specic data point shown)

4.5.6 Device and Patient Information Functions

Users can link available devices to patients, unlink currently linked devices, and update patient information directly from the Device Detail view.

4.5.6.1 Link a Device

To link an available device to the current patient:

1. Tap the additional function button in the lower right corner of the screen, on the right side of the identier panel.

Tap

Link Device

. The Link New Device view will appear.

Figure 18. Link New Device View

Show designated area devices—If selecting only from devices associated with a specic area of care, tap the check box to check it and reveal the Designated Area eld. Otherwise, leave the check box unchecked and skip to Step 6.

Designated Areas

areas.

—Tap the rightward-pointing arrow to open the drop-down menu showing available

Figure 19. Link Device View (designated area selection)

Note: Areas and designated area devices available in the app are set up in the Vital Sync platform. Note: Selecting Other in the list will show devices not specically set up in the platform as designated area

devices.

5. Tap the desired area to select it. If the desired area is not immediately visible, enter the area name (or the rst few characters of the name) in the Search eld to lter the list.

Note: The list shows parent areas and child areas for available devices. Take care to select correctly from the list if desiring devices associated with a specic child area.

Note: Take care to not select a child area and its parent area from the list at the same time, as this may interfere with changing assignment levels in the app for the patient to whom a designated area device is linked.

Device Category—Select the desired device type from the drop-down menu.

Device ID—Select the desired device from the drop-down menu.

Tap LINK to link the device, or tap CANCEL to exit the view without linking the device.

If the desired device is not immediately visible in the Device ID eld, click the refresh button next to the Device Category eld, then click the Device ID drop-down menu again.

4.5.6.2 Unlink a Device

To unlink a device from the current patient:

1. Tap the additional function button in the lower right corner of the screen, on the right side of the identier panel.

Tap Unlink Device. The Unlink Device view will appear. Figure 20. Unlink Device View

Device Category

Device ID

Tap

A dialog box will appear asking for conrmation of unlinking. Tap

If needing to unlink additional devices, repeat the previous four steps. Otherwise, tap view.

4.5.6.3 Update Patient Information

To update information for the current patient:

1. Tap the additional function button in the lower right corner of the screen, on the right side of the identier panel.

Tap Update Patient. The Update Patient view will appear.

—Select the desired device from the drop-down menu.

UNLINK

—Select the desired device type from the drop-down menu.

to unlink the device, or tap

CANCEL

to exit the view without unlinking the device.

Yes

to conrm, or tap No to cancel.

CANCEL

to exit the

Figure 21. Update Patient View

Patient ID—If desired, enter a dierent patient ID number. Note: If the number entered is already assigned to another patient, an error message will appear. If this

happens, tap CANCEL, then access the Update Patient view again and enter a dierent ID number.

First Name—If desired, enter a dierent rst name.

Middle Name—If desired, enter a dierent middle name.

Last Name—If desired, enter a dierent last name.

Date of Birth—If desired, enter a dierent date of birth (MM/dd/yyyy format; the app automatically inserts slashes).

When done updating information, tap UPDATE to save changes, or tap CANCEL to exit the view without saving changes.

4.5.7 Remote Setting Changes

Selected app users can change certain settings on supported devices directly from the Device Detail view. For a list of devices that support remote setting changes in this release of the app, see Section 2.6.

Note: Enabling the remote setting change function requires specic user conguration. Consult with the Medtronic Solution Delivery Team for assistance.

To remotely change a setting on a supported device:

1. In the Device Detail view, select the desired parameter.

2. Swipe left in the information panel until the threshold settings page is visible, showing current settings for the selected parameter.

Figure 22. Information Panel (threshold settings)

3. Tap the setting to be changed, then enter the new value.

When done changing settings, tap Apply.

A dialog box will appear asking for conrmation of the setting change. Tap Yes to conrm, or tap No to cancel the change.

4.5.8 Manually Discharge a Patient

Users can manually discharge patients directly from the Device Detail view. This removes them from monitoring in the platform.

To manually discharge a patient:

1. Tap the bed tile for the desired patient to access the Device Detail view.

2. Tap the additional function button in the lower right corner of the screen, on the right side of the identier panel.

Tap Discharge Patient.

A dialog will appear asking if the patient should be discharged. Tap Yes to conrm, or No to cancel and return to the Device Detail view.

Note: The discharge functionality removes the patient from monitoring in the platform. This functionality is distinct from procedures or systems used to physically discharge the patient from the facility.

4.6 Active Alarms View

To access the Active Alarms view, tap the Active Alarms view button (leftmost on the button bar).

Note: Before acting on information shown in the app, assess the patient at the bedside to conrm the information shown.

Figure 23. Active Alarms View

1 Bed tiles with alarms

2 Bed tile with notication

4.6.1 Available Tasks

Users can see their patients with active alarms in this view.

4.6.2 Event Information

The Active Alarms view shows only patients assigned to the user whose devices have active alarms or notications. The information shown on bed tiles in the view is the same as is shown in the Assigned Patients view. For more information, see Section 4.4.2.

Note: The event icon shown and the color of the tile outline and message area depend on the event type (alarm or notication) and priority (high, medium, low, or informational).

Note: If multiple events are active for a patient, the icon and message for the event with the highest priority will appear on the tile.

To access the Device Detail view for any patient in the Active Alarms view, tap the desired bed tile.

4.7 Patient Management View

To access the Patient Management view, tap the Patient Management view button (third from left on the button bar).

Figure 24. Patient Management View (initial access)

4.7.1 Available Tasks

Users can perform the following tasks in or from this view:

• Admit new patients

• Assign admitted patients to themselves

• Identify and begin in-app monitoring for patients admitted in the platform via ADT functionality or linked to auto-associated devices

• Change the assignment type for their own assignments

• Remove their own assignments

• See a list of users assigned to any patient

4.7.2 Admit a Patient

To admit a patient into the platform via the app:

In the Patient Management view, tap the New Admission button, located in the lower left corner of the view. The Admit Patient view will appear.

Figure 25. Admit Patient View (initial access)

Area—Select the desired area from the drop-down menu. Figure 26. Admit Patient View (area selection)

Bed Location—Select the desired bed from the drop-down menu.

Figure 27. Admit Patient View (bed selection)

Patient ID—Enter the patient ID to be used for this patient.

Tap the search button to the right of the Patient ID eld. If the patient ID is already in use, the app will show a message indicating the patient is already being monitored. If not, the app will show a message indicating the ID was not found.

Figure 28.

Admit Patient View (patient ID selection)

Tap NEXT to continue to the patient information page, or tap CANCEL to exit the view without admitting the new patient.

Figure 29. Admit Patient View (patient information)

First Name—Enter the patient’s rst name. This eld is optional.

Last Name—Enter the patient’s last name. This eld is optional.

Date of Birth (MM/dd/yyyy)—Enter the patient’s date of birth in the format shown (the app will automatically insert slashes). This eld is optional.

10.

Tap NEXT to continue to the device and assignment selection page, or tap BACK to return to the previous page in the view.

Figure 30. Admit Patient View (device and assignment selection)

11.

12.

Designated Areas

areas.

—Tap the rightward-pointing arrow to open the drop-down menu showing available

Figure 31. Admit Patient View (designated area selection)

devices.

13. Tap the desired area to select it. If the desired area is not immediately visible, enter the area name (or the rst few characters of the name) in the Search eld to lter the list.

Note: The list shows parent areas and child areas for available devices. Take care to select correctly from the list if desiring devices associated with a specic child area.

14.

Device Category—Select the desired device type from the drop-down menu.

15.

Device ID—Select the desired device from the drop-down menu. Note: A device must be assigned in order to admit a patient in the platform via the app.

16.

Assignment Level—Tap the button for the desired assignment level for this patient. Selecting Primary, Secondary, or Monitoring will assign the patient to the current user at that level, while selecting O will

leave the patient unassigned once admitted.

17.

Tap FINISH to admit the patient in the platform, or tap BACK to return to the previous page in the view.

Once the patient is admitted, the app will show the Device Detail view for that patient. All other patient functions are also available.

Note: After admitting or identifying a patient via the app, conrm that the patient physically present in the bed is the patient indicated in the app. Also, conrm that the device linked to that patient in the app is physically present with the patient.

4.7.3 Assign Patients

To assign a patient or change an assignment type:

1. Tap the drop-down menu at the top of the Patient Management view to open it. A list of areas of care will appear.

Figure 32. Patient Management View (area drop-down menu)

Note: Areas of care in the Patient Management view correspond with areas set up in the associated

Vital Sync virtual patient monitoring platform and informatics manager.

2. Tap the desired area in the list. A list of patients in that area, each on their own assignment tile, will appear.

Figure 33. Patient Management View (assignment tiles)

1 Assignment tile

2 Patient and bed information

3 Assignment buttons

On each assignment tile, the highlighted button indicates the patient’s current assignment type for this user.

To assign a patient as a primary assignment, tap the Primary button below that patient’s name. To assign a patient as a secondary assignment, tap the Secondary button. To assign a patient as a monitoring only assignment, tap the Monitoring button. To remove the patient assignment, tap the O button.

4. Repeat the previous step for any other patients who need to be assigned, or whose assignment type needs to be changed.

Repeat the entire procedure if needing to assign patients in another area.

Note: Removing a patient assignment only unassigns the patient from the user of the app.

Note: The app only allows users to manage their own patient assignments. Supervisory users needing to manage

other users’ assignments can do so in the Vital Sync virtual patient monitoring platform.

4.7.4 Begin Monitoring a Patient

Patients who are present in the platform without a Vital Sync patient ID will not be immediately available for monitoring in the app. This can occur when a platform user links a patient to one or more devices associated with a specic bed.

To add a patient ID and begin monitoring the patient in the app:

1. In the Patient Management view, select the area of care where the desired patient has been admitted.

2. Find the tile for the bed where the desired patient has been admitted. The tile will not show identifying information for the patient, but will instead show a Begin Monitoring button.

Tap Begin Monitoring to access the Identify Patient view.

Patient ID—Enter the patient ID to be used for this patient.

Tap the search button to the right of the Patient ID eld. If the patient ID is already in use, the app will show a message indicating the patient is already being monitored, along with that patient’s identifying information. If not, the app will show a message indicating the ID was not found, allowing further eld entry.

First Name—Enter the patient’s rst name. This eld is optional.

Last Name—Enter the patient’s last name. This eld is optional.

Date of Birth (MM/dd/yyyy)—Enter the patient’s date of birth in the format shown (the app will automatically insert slashes). This eld is optional.

Tap NEXT to continue to the assignment selection page, or tap CANCEL to return to the Patient Management view without identifying the patient.

10.

leave the patient unassigned once admitted.

11.

Tap view.

FINISH

to begin monitoring the patient in the app, or tap

to return to the previous page in the

BACK

Once the patient is identied, the app will show the Device Detail view for that patient. The patient will now be accessible for assignment in the Patient Management view, and all other patient functions are also available.

Note:

is the patient indicated in the app. Also, conrm that the device linked to that patient in the app is physically present with the patient.

4.7.5 View All Assigned Users

A list of users to whom each patient is assigned (along with the type of assignment) is accessible from the Patient Management view.

To view assigned users for a patient:

After admitting or identifying a patient via the app, conrm that the patient physically present in the bed

1. Find the tile showing the desired patient in the Patient Management view.

2. Tap the patient tile (anywhere except on the assignment buttons). The tile expands to show all assigned users, in order of assignment type.

Figure 34. Patient Management View (assignments shown)

Note: Any patient who does not have any users assigned (or only has monitoring-only users assigned) will be

denoted in the Patient Management screen with a yellow dot on their assignment tile.

4.8 Main Menu

To access the Main Menu, tap the Main Menu button (rightmost on the button bar).

Figure 35. Main Menu

4.8.1 Available Tasks

Users can perform the following tasks in or from this view:

• Update their access PIN

• Clear application data

• See and set up diagnostics to aid in troubleshooting

• See version and GTIN information for their installation of the app

• Access the current privacy statement for the app

• Log out of the app

4.8.2 Update the Login PIN

Users can set a new login PIN (to use in place of a password) or update their current PIN.

To update the login PIN:

In the Main Menu, tap Update PIN. The Update PIN view will appear.

Figure 36. Update PIN View

Current PIN—Enter the current personal identication number (if any).

New PIN—Enter the new personal identication number to be used. This number can be four, ve, or six digits long.

Conrm PIN—Enter the new number again.

Tap UPDATE PIN to save the new PIN, or tap CANCEL to return to the Main Menu without saving the new PIN.

4.8.3 Clear App Data

If needed, users can clear app data (including login information) from the mobile device.

Note: Only use this function if absolutely necessary (for example, if directed by Technical Service), as it will necessitate redoing initial app setup, as described in Section 3.4, Initial Setup, page 15.

To clear application data:

In the Main Menu, tap Clear App Data.

2. A conrmation dialog will appear. To proceed and clear all app data, including user login information, tap

Yes. To cancel and return to the Main Menu, tap No.

4.8.4 Diagnostics

Certain diagnostic information is available for the app. This information can be used to troubleshoot the app if problems occur.

To access diagnostic information:

In the Main Menu, tap Diagnostics. The Diagnostics view will appear. Figure 37. Diagnostics View

2. The following information appears in the view:

•

Notications Enabled

eld shows No.

•

FCM Token Registered on Vital Sync Server

registered FCM token for the app. If not, this eld shows No.

•

Vital Sync™ URL

currently linked.

Display Log Messages—If desired or directed, tap the switch to turn on log message display in the app.

4. To exit the Diagnostics view and return to the Main Menu, tap the leftward-pointing arrow in the lower left corner of the view.

Note: Log message display is turned o by default. For user convenience, log messages should only be displayed if needed to troubleshoot a problem with the app.

4.8.5 Version Information

The version information for the current installation of the app appears in the Main Menu.

This includes the application’s version number, build number, and global trade item number (GTIN); the GTIN serves as the unique device identier for the app. If problems arise with the app, provide this information to support personnel to aid in troubleshooting.

Note: The information shown in Figure 35 is representative. Actual version information shown may vary.

—This eld shows

—This eld shows the URL for the Vital Sync platform server to which the app is

if push notications are enabled for the app. If not, this

Yes

—This eld shows

if the platform server has a

Yes

4.8.6 Privacy

The privacy policy for the app is accessible from within the app at any time.

In the Main Menu, tap Privacy. The privacy policy will appear on the screen.

To exit and return to the Main Menu, tap the leftward-pointing arrow in the lower left corner of the view.

4.8.7 Application Logout

To log out of the app, tap Log Out in the Main Menu.

4.9 Additional Settings

Additional app settings are available via the iOS™* operating system.

Note: App settings do not generally need to be changed, as defaults should have been accepted during installation.

To access app settings:

In the mobile device home screen, tap the device’s Settings icon.

Scroll down in the Settings view to nd the list of installed apps, then tap Vital Sync. A list of application settings will appear.

4.9.1 Notication Settings

Tap

Notications

in the settings list to access notication settings.

Figure 38. Mobile Device Notication Settings

Unless overridden during installation, the app’s default setting is to allow notications, with alerts shown in the mobile device’s lock screen and notication center, and on banners that appear on the screen when the device is in use. It also defaults to allow notication sounds and badges.

•

Warning: To avoid delayed response to alarms and potential patient injury, do not disable push notications for the application.

4.9.2 Other App Settings

The app’s other settings are as follows:

•

Camera—Access to the mobile device’s camera is enabled by default. This allows use of a QR code (provided by the Medtronic Solution Delivery Team) as needed to establish access to a Vital Sync platform server.

•

Siri & Search—All options for Siri™* and device search are active by default.

•

Background App Refresh—This is enabled by default. This allows the app to send push notications to the mobile device even if the user is logged out or the app is not running.

•

Cellular Data—This is enabled by default. This allows the app to use the cellular data network as well as the local WiFi network.

Note: Background app refresh will be disabled if the mobile device is in low power mode.

5 Alarms and Notications

5.1 Overview

This chapter describes alarm information and notications in the Vital Sync mobile application.

5.2 Summary of Event Indicators

5.2.1 Visual Indicators

When a device linked to a patient has an active event (alarm or notication), visual indicators of the event (including colors and symbols) will appear in multiple locations in the app, as shown in

Table 4. Visual Alarm and Notication Indicators

Location Event type and priority

Bed tile (Assigned Patients view or Active Alarms view)

High priority alarm

Medium priority alarm

Table 4

Low priority alarm

Notication (reset alarm)

Notication (standard)

Notication (device disconnect)

Table 4. Visual Alarm and Notication Indicators (continued)

Location Event type and priority

Device Detail view (messages) High priority alarm

Medium priority alarm

Low priority alarm

Notication (reset alarm)

Notication (standard)

Notication (device disconnect)

Device Detail view (parameters) High priority alarm condition

Medium or low priority alarm condition

Device Detail view (footer) High priority alarm

High priority alarm (audible alarm paused on device)

Medium or low priority alarm

Notication

Various views Application message

Table 4. Visual Alarm and Notication Indicators (continued)

Location Event type and priority

Mobile device lock screen Push notication of device alarm (mobile device locked)

Push notication of device alarm (mobile device unlocked)

Alarm priority is denoted using specic colors, as shown in

Table 5. Alarm Colors

High-priority alarm Medium-priority alarm Low-priority alarm Notication

Red Yellow* Yellow* Light blue

*Use the icon on the tile to distinguish between priorities (two exclamation points indicates a medium-priority alarm; one exclamation point indicates a low-priority alarm).

5.2.2 Audible Indicators

There are no audible indicators within the app itself for alarms or notications.

If push notications are enabled on the mobile device, the tone associated with calendar alerts will sound whenever the mobile device receives a push notication. This will occur even if the app is not currently running or if the user is not currently logged into the app.

5.2.3 Events Shown

The app shows all high priority, medium priority, and low priority alarms from supported devices. The app also shows standard device notications, reset alarms, and device disconnection notications.

Table 5

5.3 Clear Alarm Indicators

The app does not provide any means of clearing an alarm or alarm indicator. If a device linked to a patient is in an alarm state, attend to the patient according to facility policies and procedures.

Indicators for an alarm or notication will continue to appear in the app until the event is no longer active on the device.

5.4 Pause Bedside Alarms

From the app, selected users can remotely pause audible alarms on supported devices even when not at the bedside.

To pause an audible alarm on a device, in the Device Detail view for the alarming device, tap the audio pause button on the right side of the identier panel. The bell icon will turn o-white during the audio paused period, which is established on the device itself. See the device instructions for specic information.

Note: Enabling the remote alarm audio pause function requires specic user conguration. Consult with the Medtronic Solution Delivery Team for assistance.

5.5 View Alarm and Notication Information

•

Users are notied of alarms on the mobile device via push notications. Within the Vital Sync mobile app, alarms and notications (also generally called events) are shown in several locations.

5.5.1 Push Notications

If push notications are active on the mobile device, banners will appear by default at the top of the device screen, and the audible tone (if any) set on the device for a calendar event will sound.

The software will send push notications of events for any patient assigned to the user as a primary or secondary assignment. See

Any annunciation delays set in the platform for primary or secondary assignment levels also apply to push notications. See the platform reference manual for details on annunciation delays.

Section 4.7.3, Assign Patients, page 43

for details on assignment levels.

Note:

assignment.

If the device is locked, the banner appearing on the lock screen will only show the app logo and name and the number of messages.

The software does not send push notications of events for any patient assigned to a user as a monitoring

Figure 39. Lock Screen with Push Notications (screen locked)

If the device is unlocked, the banner appearing on the lock screen will show each message, including the app logo and name, the alarm message, and the patient identier (partial name and bed number).

Figure 40. Lock Screen with Push Notications (screen unlocked)

When a banner with a Vital Sync mobile app message appears on the mobile device screen while the user is using a dierent app, it will also show the alarm message and patient identier.

If more than one push notication has been sent regarding the same patient, banners for all unread notications for that patient will be grouped together. To expand the grouping to see all push notications it includes, simply tap on the grouping. To go directly to the Vital Sync mobile app from any of its push notications, tap on the banner.

5.5.2 Bed Tiles

If a patient has events active on a linked device, the bed tile in the Assigned Patients view or Active Alarms view will change color to denote the priority of the event with the highest priority, and will show a message for the event. If the event is an alarm related to a device parameter shown on the bed tile, that parameter will change color as well.

Figure 41. Tile Detail (alarm shown)

1 Bed number

2 Patient name

3 Alarming parameter

Figure 42. Tile Detail (notication shown)

4 Event icon

5 Message

1 Bed number

2 Patient name

3 Event icon

4 Event message

5 Aected parameter

Note: If a reset alarm is active involving a parameter shown on the bed tile, the aected parameter will change color to blue.

5.5.3 Active Alarms View

Bed tiles for any of the user’s assigned patients with active and annunciating device alarms or notications will appear in the Active Alarms view. Each tile in the view has the alarm or notication message for the event with the highest priority for that patient, with a colored border corresponding to that event’s severity.

Figure 43.

Active Alarms View (all event types shown)

1 Bed tile with high-priority alarm

2 Bed tile with medium-priority alarm

3 Bed tile with low-priority alarm

4 Bed tile with notication

Note: If a patient has multiple active events, only the event with the highest priority will be shown on that patient’s bed tile in this view.

5.5.4 Assigned Patients View

Bed tiles in the Assigned Patients view for any of the user’s assigned patients with an active and annunciating device event will show the message (and corresponding colored border) for the event.

Information and colors shown are the same as in the Active Alarms view.

Figure 44. Assigned Patients View (events shown)

1 Bed tile with reset alarm

2 Bed tile with standard notication

3 Bed tile with disconnect notication

4 Bed tile with alarm

Note: If a patient has multiple active events, only the event with the highest priority will be shown on that patient’s bed tile in this view.

5.5.5 Device Detail View

To see detail for any active event, tap on the bed tile to access the Device Detail view.

Figure 45. Device Detail View (active alarm shown)

1 Message area (alarm message shown)

2 Aected parameter

3 Identier panel

The message area shows alarm or notication messages, each with an icon and a background color indicating the event type and priority. If a device parameter is in an alarm condition, it will be highlighted in red or yellow (depending on priority) and outlined in white. The identier panel at the bottom of the view also changes color to match the event with the highest priority. If the device supports remote pausing of its audible alarm tone from the app, a button to pause alarm audio will be present on the identier panel.

If a device is disconnected, the message area and identier panel will change color to light blue, and the message area will show a disconnection icon specic to the device type. The information panel will automatically show the device page.

Figure 46. Device Detail View (disconnected device shown)

Note: Parameters for other devices linked with the patient that are still communicating with the platform will still

appear in the parameter panel even when viewing device identier information for the disconnected device.

5.5.6 Stale Data

If the app does not receive data for a device parameter for more than 15 seconds, the Assigned Patients, Active Alarms, and Device Detail views will continue to show the most recent data (and any associated events) reported from the platform. To indicate that this data is stale (older than 15 seconds), the app will show the time elapsed since the most recent data was received. The elapsed time appears to the right of the parameter value in the Device Detail view, and to the right of alarm and notication message text in the Assigned Patients, Active Alarms, and Device Detail views.

5.6 Event Priority

Built-in priority rules govern how the application shows events, especially in places where only a single event may be displayed.

Event priority is set in the Vital Sync informatics manager. See the virtual patient monitoring platform and informatics manager reference manual for more information.

5.7 Alarm Behavior in the Software

Alarms behave similarly in the app to how they behave in the Vital Sync virtual patient monitoring platform. For a detailed explanation, including an explanation of annunciation delays, see the reference manual for the platform.

•

Caution: Push notications 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.

Covidien llc

*PT00161489*

15 Hampshire Street Manseld, MA 02048 USA www.medtronic.com 1 800 962 9888 [T]

Medtronic VSMASW03 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 Introduction

1.1 Overview

1.2 Applicable Version

1.3 Conventions

1.4 Safety Information

1.4.1 Warnings

1.4.2 Cautions

1.4.3 Notes

1.5 Obtaining Technical Assistance

1.5.1 Technical Services

1.5.2 Related Documents

1.6 Warranty Information

1.7 Licensing Information

1.7.1 Vital Sync and Third Party Software

Table 1. OTS and Open Source Software

1.8 HIPAA Disclaimer

1.9 Statement Regarding FDA Clearance of Features

2 Product Overview

2.1 Overview

2.2 Intended Use

2.3 Contraindications

2.4 Application Overview

2.4.1 Basic Functions

2.4.2 User Roles

2.5 User Interface Symbols

2.6 Devices Supported

3 Installation and Access

3.1 Overview

3.2 Requirements

3.3 Installation

3.3.1 Installing the App

3.3.2 Upgrade Path

3.4 Initial Setup

Figure 1. Login Settings View

Figure 2. Login Fields

Figure 3. Login with PIN Fields

3.5 Running the App

4 Operation

4.1 Overview

4.3 Navigation and Basic User Interface

Figure 4. App Layout and Navigation

Figure 5. App Layout and Navigation (menus)

4.4 Assigned Patients View

Figure 6. Assigned Patients View

4.4.1 Available Tasks

4.4.2 Bed Tile Information

Figure 7. Bed Tile Detail

4.4.3 Bed Tile Colors

4.5 Device Detail View

Figure 8. Device Detail View

4.5.1 Available Tasks

4.5.2 Parameter Panel

4.5.3 Settings Panel

4.5.4 Information Panel

4.5.4.1 Trend Page

Figure 9. Information Panel (trend page)

4.5.4.2 Waveform Page

Figure 10. Information Panel (waveform page)

Figure 11. Information Panel (waveform page; ventilator waveform)

4.5.4.3 Device Page

Figure 12. Information Panel (device page)

4.5.5 Trend Functions

4.5.5.1 Change the Trend Timeframe

1. Tap the drop-down menu at top right in the information panel to open it. Figure 13. Trend Timeframe Menu

4.5.5.2 View Trends in Landscape Mode

Figure 14. Trend Information in Landscape Mode

4.5.5.3 View a Second Trend

Second Trend—Tap to access the list of available parameters. Figure 15. Available Parameter List (Second Trend button)

Figure 16. Information Panel (trend page with two trends shown)

4.5.6 Device and Patient Information Functions

4.5.6.1 Link a Device

Figure 18. Link New Device View

Figure 19. Link Device View (designated area selection)

4.5.6.2 Unlink a Device

Tap Unlink Device. The Unlink Device view will appear. Figure 20. Unlink Device View