Medtronic VITALSYNCSW03 Operator's Manual

Vital Sync™

Virtual Patient Monitoring Platform and Informatics Manager

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.

BIS™, Capnostream™, INVOS™, Nellcor™, Newport™, OxiMax™, 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.2 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.3 Applicable Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

1.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

1.5 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.7 Licensing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.8 HIPAA Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.9 Statement Regarding FDA Clearance of Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.4 User Interface Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.5 User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

2.6 Device Types Supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3 Installation and Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3.2 System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3.3 Security Requirements and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3.4 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

4 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4.2 Access the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4.3 Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

4.4 Clinician Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4.5 Supervisor Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.6 Administrator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4.7 Functions for Other Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

5 Clinician and Supervisor Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.2 Alarms and Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.3 Navigation and Basic User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.4 Tile View (Patient Overview Screen) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5.5 Device Detail Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.6 All Patients and Devices Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

5.7 Admit a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

5.8 Manual Parameter Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

5.9 Discharge (Remove) a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

5.10 Patient Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

5.11 Area Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

5.12 Select User Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

5.13 Event List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

5.14 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

5.15 Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

5.16 Audible Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

5.17 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

5.18 Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

5.19 Platform Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

6 Administrator Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

6.2 Navigation and Basic User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

6.3 Administrative Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

6.4 Manage User Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

6.5 Manage Monitoring Station Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

6.6 Manage Bedside Display Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

6.7 Manage Shifts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

6.8 Manage Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.9 Manage Device Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

6.10 Device Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

6.11 Manage Alarm, Notification, and Setting Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

6.12 Manage Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

6.13 Manage Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

6.14 Manage Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

6.15 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

6.16 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

6.17 Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

6.18 Platform Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

7 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

7.2 Summary of Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

7.3 Clear Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

7.4 Audible Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

7.5 View Alarm Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

7.6 Filtered Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

7.7 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

7.8 Alarm Behavior in the Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

8 Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

8.2 Summary of Notification Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

8.3 View Notification Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

8.4 View and Acknowledge Setting Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

8.5 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

9 Supplementary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

9.2 Alarm Communication from Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

9.3 Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

9.4 Alarm Functionality and Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

9.5 Alarm Rule Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

9.6 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

9.7 Default Alarm Priority by Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

9.8 Audible Alert Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

9.9 Device Auto-Reconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

9.10 Device Data Handling After Unlinking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190

9.11 Admission, Discharge, and Transfer (ADT) Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

9.12 Web API Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

10 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

10.2 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

10.3 Report Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

10.4 Clinician and Supervisory Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

10.5 Administrative Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Figures

Figure 1. Login Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Figure 2. Common Navigation Bar (Standard) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Figure 3. Function Menu (Clinician) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Figure 4. Function Menu (Supervisor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Figure 5. Alarm Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 6. Notification Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 7. Device Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 8. Example Function Drop-Down Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Figure 9. Example System Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Figure 10. Tool Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Figure 11. Patient Overview Screen (Tile View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Figure 12. Bed Tile Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Figure 13. Device Tile Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Figure 14. Bed Tile (patient name masked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Figure 15. Device Detail Screen Layout (ventilator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Figure 16. Device Detail Screen Layout (pulse oximeter or capnography monitor) . . . . . . . . . . . . 55

Figure 17. Device Detail Screen Layout (derived parameter algorithm) . . . . . . . . . . . . . . . . . . . . . 55

Figure 18. Patient Header Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Figure 19. Patient Header Panel (alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Figure 20. Device Header Panel (ventilator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 21. Device Header Panel (pulse oximeter or capnography monitor) . . . . . . . . . . . . . . . . . . 57

Figure 22. Device Header Panel (regional saturation monitor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 23. Parameter Panel (ventilator data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 24. Parameter Panel (pulse oximeter data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 25. Parameter Panel (capnography monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 26. Parameter Panel (bispectral index monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 27. Parameter Panel (multiparameter monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Figure 28. Parameter Panel (four-channel regional saturation monitor data) . . . . . . . . . . . . . . . . . 61

Figure 29. Parameter Panel (two-channel regional saturation monitor data) . . . . . . . . . . . . . . . . . 61

Figure 30. Waveform Panel (ventilator data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 31. Waveform Panel (pulse oximeter data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 32. Waveform Panel (capnography monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 33. Settings Panel (ventilator settings) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 34. Trend Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 35. Event Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Figure 36. Parameter Trend Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Figure 37. Parameter Trend Window (alarm and setting change icons and alarm message

shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Figure 38. Parameter Trend Window (specific data point shown) . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Figure 39. Waveform Detail Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Figure 40. Waveform Detail Window (specific data shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Figure 41. Waveform Detail Window (specific data shown for multiple ventilator waveforms) . . . 69

Figure 42. Device Detail Screen (patient information fields) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Figure 43. Update Patient Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Figure 44. Update Patient Location Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Figure 45. Rules and Settings Dialog (example delay rules shown) . . . . . . . . . . . . . . . . . . . . . . . . 72

Figure 46. Rules and Settings Dialog (example alert thresholds shown) . . . . . . . . . . . . . . . . . . . . 73

Figure 47. All Patients and Devices Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Figure 48. All Patients and Devices Screen (assignments shown for a patient) . . . . . . . . . . . . . . 76

Figure 49. Tile View (device tile dragged onto bed tile at lower left) . . . . . . . . . . . . . . . . . . . . . . . . 77

Figure 50. Admit Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Figure 51. Admit Patient Screen (available device list) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Figure 52. Link New Device/Algorithm dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

Figure 53. Device Detail Screen (making a device primary) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Figure 54. Device Detail Screen (device disconnected from the platform) . . . . . . . . . . . . . . . . . . . 82

Figure 55. Replace Linked Device Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Figure 56. Device Detail Screen (manual discharge) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Figure 57. Patient Discharge History Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Figure 58. Patient Assignment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Figure 59. Patient Assignment Screen (unassigned patients shown) . . . . . . . . . . . . . . . . . . . . . . . 90

Figure 60. Patient Assignment Screen (other user selected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Figure 61. Patient Assignment Screen (other user’s assignments) . . . . . . . . . . . . . . . . . . . . . . . . 91

Figure 62. Patient Assignment Screen (shift menu shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Figure 63. Area Assignment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Figure 64. Area Assignment Screen (unassigned areas shown) . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Figure 65. Area Assignment Screen (other user selected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Figure 66. Area Assignment Screen (other user’s assignments) . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Figure 67. Area Assignment Screen (shift menu shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Figure 68. Select User Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Figure 69. Navigation Bar and Function Menu (Select User Mode) . . . . . . . . . . . . . . . . . . . . . . . 101

Figure 70. Event List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Figure 71. Device Detail Screen (Patient Reports tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Figure 72. Change Password Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Figure 73. Audible Alerts Dialog (control of alerts locked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Figure 74. Audible Alerts Dialog (control of alerts unlocked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Figure 75. Version Information (About) Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Figure 76. Example Administrative Navigation Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Figure 77. Example System Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Figure 78. Column Sort (cursor and heading to be sorted shown) . . . . . . . . . . . . . . . . . . . . . . . . 111

Figure 79. Administrative Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Figure 80. Manage User Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Figure 81. Manage User Accounts Screen (inactive accounts shown) . . . . . . . . . . . . . . . . . . . . 114

Figure 82. Create User Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Figure 83. Edit User Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

Figure 84. User Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Figure 85. User Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

Figure 86. User Account Deletion Confirmation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Figure 87. User Account Unlock Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Figure 88. Password Reset Confirmation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Figure 89. Password Reset Confirmation Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Figure 90. Change Password Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Figure 91. Manage Monitoring Station Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Figure 92. Manage Monitoring Station Accounts Screen (inactive accounts shown) . . . . . . . . . 122

Figure 93. Edit Monitoring Station Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Figure 94. Monitoring Station Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Figure 95. Monitoring Station Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Figure 96. Manage Bedside Display Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Figure 97. Manage Bedside Display Accounts Screen (inactive accounts shown) . . . . . . . . . . . 126

Figure 98. Edit Bedside Display Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Figure 99. Bedside Display Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Figure 100. Bedside Display Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Figure 101. Manage Shifts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Figure 102. Add Shift Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Figure 103. Edit Shift Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Figure 104. Manage Areas Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Figure 105. Add Areas Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Figure 106. Edit Area Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Figure 107. Manage Beds Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Figure 108. Add Bed Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Figure 109. Edit Bed Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Figure 110. Manage Device Inventory Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Figure 111. Add Device Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Figure 112. Edit Device Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Figure 113. Device Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Figure 114. Device Detail Window (General tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Figure 115. Device Detail Window (Support tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Figure 116. Manage Rule Sets Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Figure 117. Add Rule Set Screen (Alarm Rules tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Figure 118. Add Rule Set Screen (Settings Rules Tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Figure 119. Edit Rule Set Screen (Alarm Rules tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Figure 120. Edit Rule Set Screen (Settings Rules Tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Figure 121. Custom Alarm Rule Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Figure 122. Alarm Rules Tab (with custom rule) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Figure 123. Alarm Rules Tab (custom rule deletion) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Figure 124. Manage Alerts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Figure 125. Alert Edit Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Figure 126. Manage Parameters Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Figure 127. Upload Parameter Definitions Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Figure 128. Manage Algorithms Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Figure 129. Add Algorithm Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Figure 130. Version Information (About) Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

Figure 131. Common Navigation Bar (alarms indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Figure 132. Silence Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Figure 133. Silence Button (alerts silenced) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Figure 134. Bed Tile (platform alert silence indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Figure 135. Bed Tile (device alarm pause or silence indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Figure 136. Patient Header Panel (device alarm pause or silence indicated) . . . . . . . . . . . . . . . 163

Figure 137. Bed Tile (alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Figure 138. Bed Tile (secondary alarm indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Figure 139. Patient Header (active alarm indicated on device) . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Figure 140. Parameter Panel (alarm indicators shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Figure 141. Parameter Trend Window (alarm message shown) . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Figure 142. Event Panel (alarms and durations shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 143. Alarm Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 144. Bed Tile (filtered alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Figure 145. Bed Tile (secondary alarm indicator shown for filtered alarm) . . . . . . . . . . . . . . . . . 167

Figure 146. Patient Header (filtered alarm indicated on device) . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Figure 147. Parameter Panel (filtered alarm indicated for parameter) . . . . . . . . . . . . . . . . . . . . . 168

Figure 148. Event Panel (filtered alarm message shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

Figure 149. Filtered Out Alarm Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Figure 150. Common Navigation Bar (notifications indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Figure 151. Bed Tile (reset alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Figure 152. Bed Tile (setting change indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Figure 153. Bed Tile (device disconnection indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Figure 154. Bed Tile (informational notification indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Figure 155. Bed Tile (unfavorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Figure 156. Bed Tile (favorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Figure 157. Bed Tile (secondary notification indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 158. Patient Header (standard notification indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 159. Patient Header (unfavorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 160. Patient Header (favorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Figure 161. Parameter Panel (reset alarm indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Figure 162. Settings Panel (changed settings shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Figure 163. Unacknowledged Settings Changes Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178

Figure 164. Patient Reports Tab in Device Detail Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Figure 165. Reports Screen (including example selection buttons and output) . . . . . . . . . . . . . 194

Figure 166. Calendar Drop-Down Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

Figure 167. Time Drop-Down Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

Figure 168. Comprehensive Oximetry and Capnography Report (initial page) . . . . . . . . . . . . . . 199

Figure 169. Comprehensive Oximetry and Capnography Report (comparison summary) . . . . . 200

Figure 170. Oxygenation Snapshot Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Figure 171. Reported Apneas Per Hour Report (12-hour output shown) . . . . . . . . . . . . . . . . . . . 205

Figure 172. Ventilation Snapshot Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Figure 173. Alarm Duration by Time of Day Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209

Figure 174. Alarm Occurrence Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Figure 175. Alarm Threshold Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Figure 176. Device Usage Hours Per Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Figure 177. Device Utilization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Figure 178. Highest Frequency Setting Changes Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

Figure 179. Monitored Patients Per Day Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220

Figure 180. Alarm Normalization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

Figure 181. Alarm Rule Set Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Figure 182. Subscription Utilization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

Figure 183. Application Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

Figure 184. Connectivity Details Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Figure 185. Connectivity Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

Figure 186. DPA Usage Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 234

Figure 187. Historical Performance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236

1 Introduction

1.1 Overview

This manual provides instructions for the Vital Sync virtual patient monitoring platform and informatics manager software. It includes functionality descriptions for users acting in a clinical, supervisory, or link management role, as well as for system and clinical administrators.

• Section 1.2, Conventions • Section 1.6, Warranty Information

• Section 1.3, Applicable Version • Section 1.7, Licensing Information

• Section 1.4, Safety Information • Section 1.8, HIPAA Disclaimer

• Section 1.5, Obtaining Technical Assistance

1.2 Conventions

Text and terminology conventions used in this manual include the following:

• Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment.

• Cautions alert users to exercise appropriate care for safe and effective use of the product.

• Notes provide additional guidelines or information.

• “Clinician” generally refers to nurses, physicians, respiratory care professionals, and other caregivers.

• “Platform” and “platform component” generally refer to functional areas of the software accessible to users acting as clinicians, supervisors, and link managers.

• “Software” generally refers to functional areas accessible to users acting as administrators and clinical administrators, and also to the product as a whole.

• Button names, menu options, field names, and report field names appear in boldface text.

• “Click” refers to the action activating buttons and menus in the software user interface. If using a touchscreen, substitute “touch” for “click” where it appears in the text.

• “Drag and drop” refers to clicking on or touching a user interface element, moving it over another user interface element, then letting go of the mouse button or breaking contact with the touchscreen.

• Unless otherwise specified, “device” refers to patient devices (for example, pulse oximeters, ventilators, or capnography monitors), not to smartphones, tablets, or optional dedicated bedside display units used to access and perform functions in the software.

• “Priority” and “severity” are used interchangeably to refer to events.

• “Event” refers both to alarms and notifications from devices and algorithms.

Note: The terms “clinician”, “supervisor”, “administrator”, “clinical administrator”, “link manager”, and “external services user”, as used in this manual, refer only to types of users and to roles fulfilled when using the software. These terms do not necessarily correspond to similar titles used for employees of any particular facility, nor to functions those employees perform at that facility.

Note: Names of persons and facilities used as examples in this document are fictitious, and are intended for illustrative and instructional purposes only. Any similarity to actual names of persons or facilities is coincidental.

1.3 Applicable Version

This manual applies to version 3.0 of the Vital Sync virtual patient monitoring platform and informatics manager.

Users can view specific version information for their installation by accessing the Version Information (“About”) dialog in the software.

1.4 Safety Information

This section contains generally applicable safety information for this product.

1.4.1 Warnings

• Warning: The Vital Sync Virtual Patient Monitoring Platform and Informatics Manager is intended to supplement and not to replace any part of the facility’s monitoring. Do not rely on the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager 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: The platform 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: The dedicated bedside display unit is designed for use in conjunction with the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager. Do not rely on the dedicated bedside display unit as a primary source of alarms.

• Warning: Always follow the facility’s established patient safety protocols when using the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager.

• Warning: The alarm rule functionality within the software is intended to supplement and not replace any part of the facility’s monitoring. Do not rely on the platform as the sole source of alarms.

• Warning: Alarm rules should adhere to facility policy, procedures, and alarm management protocols. This alarm management protocol should address alarm safety and the potential impact of alarm fatigue in all patient care areas within the facility.

• Warning: Alarm priority normalization and ranking functionality within the software is intended to supplement and not replace any part of the facility’s monitoring. Do not rely on the platform as the sole source of alarms.

• Warning: The default alarm priority is determined by the connected device, and cannot be changed on the device itself. The same alarm condition may be reported with a different priority on different device models. Carefully review the Alarm Normalization Report for default alarm priorities for each connected device model.

• Warning: Alarm priorities in the software should not be set to be lower than those on the actual device. Use caution if changing the priority of a device alarm in the software to a different level than is indicated on the actual device, especially for devices that are life-sustaining.

• Warning: Alarms from connected devices should not be set as notifications in the platform, especially for devices that are life-sustaining. Because notifications do not audibly annunciate, setting an alarm as a notification may cause users to not respond or delay in responding to a clinically significant event.

• Warning: Notifications from connected devices should not be set as alarms in the platform, especially for events not requiring clinical intervention. Setting a notification as an alarm may create nuisance audible alerts that are not clinically significant.

• Warning: If using audible alerts, ensure the sound volume of the PC or mobile device on which the software is used is sufficient for alerts to be heard and recognized.

• Warning: It is possible for the platform’s audible alert tone to be confused with audible alarm tones from connected devices when in close physical proximity. Users should carefully attend to all audible indicators when within audible range of connected devices.

• Warning: When setting alarm rules and priorities in the software for any device, consult the operator’s manual for the device in question for default priority levels of device alarms, and for a description of each device alarm. Obtain a detailed understanding of the patient or device conditions that trigger any alarm before creating an alarm rule or adjusting the alarm’s priority in the software.

• Warning: Medtronic does not assume any responsibility for accuracy, reliability, or clinical relevance of user-designed derived parameter algorithms.

• Warning: Remote control functionality allows modification of threshold settings and silencing of audible alarms on supported devices. These actions are visible in the platform user interface, but require version 3.0.0 of the Vital Sync Mobile Application to perform. See the Vital Sync Mobile Application (version 3.0.0) reference manual for a list of devices that support remote control functionality.

1.4.2 Cautions

• Caution: Federal law restricts this device to sale by or on the order of a physician.

• Caution: Do not set alarm limits to extreme values that render the monitoring system useless. Ensure alarm limits are appropriate for each patient.

• Caution: Connected devices report data to the platform periodically, not continuously. Because of this, as well as delays caused by network bandwidth or hardware limitations or network loading, the true duration of any device alarm will be longer than the delay set in this screen for that alarm. Carefully consider these factors when choosing delay settings, and use the shortest delay settings that are practical to reduce nuisance alarms, to avoid undue delay in response to events actually requiring direct clinical intervention.

• 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: For the most accurate interpretation of data and alerts from the Vital Sync software, the intended user (operator) position is less than 4 meters from the display screen and audio speakers.

1.4.3 Notes

• Note: Before use, carefully review appropriate sections of this manual and the operator’s manual for each connected device, applicable accessory instructions for use, and all precautionary information and specifications.

• Note: The platform’s data and audible alerts (including those appearing on optional dedicated bedside display units) are informational. Except as specified for derived parameter algorithms with adjustable alarm thresholds, the platform does not provide the ability to change device settings or control linked devices in any way (including adjusting or silencing device alarms).

• Note: Before acting on information shown in the platform, assess the patient at the bedside.

• Note: Patients monitored via optional dedicated bedside display units should also be monitored at a central monitoring station, as the dedicated bedside display unit is not intended to be a primary source of alarms.

• Note: Some smartphones and tablets do not support the sounding of audible alerts from the platform. Make sure to test audible alert capability.

• Note: Audible alerts only sound to indicate alarms on devices linked to patients. Audible alerts do not sound for notifications.

• Note: Software performance and system health should be consistently monitored to allow timely detection and resolution of problems, especially with communication of alarm messages.

• Note: A real-time application event list and multiple system performance reports are available in the Vital Sync software. Refer to Section 5.13, Event List, page 102 and Section 10.5, Administrative Reports, page 221 for details.

• Note: The platform has been verified on systems using Microsoft™* Windows™* and Windows™*-based software. User experience may vary with other operating systems and hardware and software configurations.

1.5 Obtaining Technical Assistance

1.5.1 Technical Services

For technical information and assistance if unable to correct a problem while using the platform or platform-related applications, contact a local Medtronic representative, or contact Medtronic Technical Services directly.

Medtronic Technical Services

15 Hampshire Street

Mansfield, MA 02048 USA

1 800 497 4968, or 1 925 463 4635, or contact a local Medtronic representative

HIMSupport@Medtronic.com

When calling Medtronic or a local Medtronic representative, provide the software version number, build number, date of build, and GTIN (Global Trade Item Number), shown on the About screen.

1.5.2 Related Documents

Before using the software, carefully review appropriate sections of both this manual and the operator’s manual for any connected device. This information is essential for understanding the software’s functions and information displays.

Also read all precautionary information and specifications, both for the platform (and any platform-related applications installed) and for any connected device.

1.6 Warranty Information

The information contained in this document is subject to change without notice. Medtronic makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Medtronic shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

1.7 Licensing Information

Licenses obtained from Medtronic for use of the virtual patient monitoring platform (including the informatics manager) do not include licenses for any third party software, including software identified in the platform installation manual.

Users must obtain their own licenses for the downloading and use of such third party software.

1.8 HIPAA Disclaimer

The Vital Sync Virtual Patient Monitoring Platform and Informatics Manager is a software application used in conjunction with electronic medical devices within the customer’s secure health information system. Healthcare providers using the software are expected to take appropriate security measures to protect the confidentiality of all data created, stored or transmitted on their systems. See Section 3.3, Security Requirements and Recommendations, page 27.

Although the software contains certain features to assist users in the users’ steps to protect their data, Medtronic cannot provide any assurance that the user’s use of the software will comply with HIPAA regulations or be otherwise in compliance with the customer’s obligations as a covered entity.

1.9 Statement Regarding FDA Clearance of Features

The remote control feature in the Vital Sync software has not been cleared by the United States Food and Drug Administration. The feature is being introduced using FDA’s Enforcement Policy for

Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised), updated October

2020.

2 Product Overview

2.1 Overview

This chapter provides an overall description of the functionality of the Vital Sync virtual patient monitoring platform and informatics manager software.

• Section 2.2, Intended Use • Section 2.5, User Interface Symbols

• Section 2.3, Contradindications • Section 2.6, Device Types Supported

• Section 2.4, User Interface Overview

2.2 Intended Use

The Vital Sync Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms and alarms routed through the Vital Sync Informatics Manager from supported devices.

The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals in a hospital or hospital-type facility for the following purposes:

• To remotely view and review patient data, waveforms, alerts, and alarm information from supported devices and clinical information systems to facilitate clinical management.

• To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.

• To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.

• To set and adjust thresholds on supported devices where this capability is not available on the device itself.

• To access data, waveforms and alerts from supported devices where these capabilities are not enabled or available on the device itself.

• To remotely control supported devices. Note: This functionality requires use of the Vital Sync Mobile Application. Remote-control functionality has not been cleared by the FDA and is being released per FDA’s

Enforcement Policy for Non-Invasive Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised), updated October 2020.

Warning: The Vital Sync Informatics Manager and Virtual Patient Monitoring Platform are notification

systems and are not replacements for direct patient observation, patient assessment, or clinical judgment.

2.3 Contraindications

None.

2.4 User Interface Overview

The Vital Sync virtual patient monitoring platform is designed to allow nurses, physicians, respiratory care professionals and other caregivers (referred to in this manual as “clinicians”), as well as users acting in a supervisory role, to access data from connected devices via a computer terminal, smartphone, tablet, or optional dedicated bedside display unit.

The Vital Sync informatics manager is designed to allow administrative users to access and manage system records for users, devices, algorithms, locations, and shifts; perform alarm rule and normalization functions; and view system events and performance.

Users view data and perform other program functions within a Web browser window.

2.4.1 Basic Functions

Users can view general information, including alarms and advisory messages, for multiple medical devices. The platform supports a wide range of devices.

In the general device view (called the Tile View), each bed and unassociated device is represented by a tile. Clicking on a bed tile accesses detailed information for a specific bed and devices linked to the patient in that bed. Clicking on a tile for an unassociated device, or dragging it onto a bed tile, accesses functions for linking the device to a patient.

Patient names in the Tile View can be masked if desired to enhance patient privacy, especially if using the software at a central monitoring station.

Users can also admit patients in the platform; create, manage, and remove links between patients and devices; and discharge patients within the platform if appropriate. They can also create and remove patient and area assignments. Shift management features help streamline the process of assigning patients and areas to individual clinicians and supervisors.

Device, bed, and area management functions allow users to associate individual devices (including optional dedicated bedside display units) with specific beds in the facility, and to define areas in the platform that correspond with specific locations (also sometimes referred to as zones or areas of care) within the facility. Areas are assignable to specific clinicians and supervisors just as patients are, and can be designated as home areas for central monitoring station accounts to streamline patient assignment at associated stations.

Alarm and event management functions allow users to set up rule sets to refine the timing of alarm and notification annunciation in the platform, also known as alarm filtering; this can assist in reducing the incidence of nuisance alarms. In addition, users can adjust alarm priorities for devices in the platform, in order to normalize alarm priorities across a facility.

Single-tone or multi-tone audible alerts are available, allowing users to hear as well as see alarm indications when using the platform. Audible alerts can be enabled or disabled for any user. Any user who has audible alerts enabled can temporarily silence them as they occur. The platform visually indicates silenced alerts, alarms paused or silenced on devices, and filtered alarms.

Reporting functions allow access to both current and historical information about monitored devices and patients, users and usage, and the functioning of the platform itself. These can be used in conjunction with derived parameter algorithms (which can be linked to patients in the same way as devices are) as an aid in monitoring and managing patient conditions. They also allow system administrators to monitor performance and events within the platform, and also on its associated hardware.

The platform supports the use of optional dedicated bedside display units, which allow view-only access to patient and device data for a specific bed, and are especially intended for devices that use the platform as their primary user interface. The platform also can be used at a central monitoring station, via a non-user-specific account specifically designed for this purpose.

• Note: The platform’s data displays and audible alerts (including those appearing on optional dedicated bedside display units) are informational. Except as specified for derived parameter

algorithms with adjustable alarm thresholds, the platform does not provide the ability to change device settings or control linked devices in any way (including adjusting or silencing device alarms).

• Note: The current release of this software allows viewing of data from ventilators, capnography monitors, pulse oximeters, regional saturation monitors, bispectral index monitors, and multiparameter monitors. The software also shows information from derived parameter algorithms. See Section 2.6, Device Types Supported, page 25 for a list of specific device types with which this software is usable.

• Note: Some smartphones and tablets do not support the sounding of audible alerts from the platform. Make sure to test audible alert capability.

2.4.2 User Roles

Each user is identified in the software by username and password, and enters these to log into the software. Functions available depend on the user’s assigned role.

• Clinicians—Users in this role may view device information for many patients and devices at once in a tiled overview screen, clicking on any tile to access detailed information. They may also link devices with patients in the platform, manage patient identifying information and links between patients and devices, and manage their own patient and area assignments. They will hear an alert tone (if enabled in the platform) when a device linked to any of their patients enters an alarm state, and may also receive email and text message alerts for alarms. Several reports are available for clinicians, most notably “snapshot” reports showing oxygenation or ventilation data for specific patients, as well as apnea event information for multiple patients.

• Supervisors—Users in this role are able to perform the same tasks in the platform as clinicians can, complemented with additional functions to assist in their supervisory role. These functions include a multi-device list view; the ability to manage patient and area assignments for other users; and a virtual user function allowing a view of the platform as the selected clinician would see it. A wide range of reporting functions is also available, providing information on alarm and setting change information, system utilization statistics, and other historical data.

• Administrators—Users in this role perform various system administration functions. They may set up, maintain and deactivate user accounts in the platform, reset passwords, and unlock locked-out users (if the deployment allows). They also manage the inventory of connected devices; set up and maintain beds, areas, and work shifts; assign beds to bedside display units; and assign home areas for central monitoring stations. Administrators manage rule sets governing alarm and event annunciation, normalize alarm priorities in the platform (if needed), and may set up algorithms and derived parameter algorithms in addition to those already supported in the platform. They also may access event and system performance logs and usage reports, as well as reports showing alarm rule setting and priority information.

• Clinical Administrators—Users in this role access the platform as administrators do, but are not tasked with direct management of users, locations, or devices. Instead, their role is to manage alarm and event priorities, rules, and rule sets, as well as to manage parameters and derived parameter algorithms.

• Link Managers—Users in this role access the platform as clinicians and supervisors do, but do not directly monitor patients. Instead, their role is to link devices to patients to support reporting of device data to an electronic medical record (eMR) system. As such, link manager functionality is limited to linking of devices and management of existing links. Consult the Medtronic Solution Delivery Team for more details, and for information on enabling this role.

• External Services—Users in this role manage and configure interfaces between the platform and various external application services. Consult the Medtronic Solution Delivery Team for more details.

In addition to using the platform on a PC, smartphone, or tablet, users may also access it via a central monitoring station (which does not require individualized login credentials) or on an optional dedicated bedside display unit, which runs a streamlined version of the software and shows patient and device data for a single bed. Consult the Medtronic Solution Delivery Team for more details on setup for either of these options. (Platform operations at central monitoring stations or on bedside units are similar to those for individual users, varying only in the scope of functions available.)

• Note: Patients monitored via dedicated bedside display units should also be monitored independently at a central monitoring station, as the dedicated bedside display unit is not intended to be a primary source of alarms.

• Note: The terms “clinician”, “supervisor”, “administrator”, “clinical administrator”, “link manager”, and “external services user”, as used in this manual, refer only to types of users and to roles fulfilled when using the software. These terms do not necessarily correspond to similar titles used for employees of any particular facility, nor to functions those employees perform at that facility.

2.5 User Interface Symbols

The software makes use of icons and symbols to denote user functions and to show data from patients and devices. These are defined in the tables in this section.

Note: Some symbols may appear in different colors in the software than are shown in the tables (for example, device icons shown in dark colors on a light background here may, in certain locations, appear in light colors on a dark background). Unless noted, symbols in the tables have the same meaning even if appearing in a different color scheme than is shown here.

Table 1. Device Symbol Definitions

Icon Description Definition

Ventilator Represents a ventilator linked to a patient in the platform, or

available for linking. Appears in various locations in the platform.

Capnography monitor Represents a capnography monitor linked to a patient in the

platform, or available for linking. Appears in various locations.

Pulse oximeter Represents a pulse oximeter linked to a patient in the plat-

form, or available for linking. Appears in various locations.

Bispectral index (BIS) monitor

Regional saturation monitor

Multiparameter monitor Represents a multiparameter monitor linked to a patient in

Represents a bispectral index monitor linked to a patient in the platform, or available for linking. Appears in various locations.

Represents a regional saturation monitor linked to a patient in the platform, or available for linking. Appears in various locations in the platform.

the platform, or available for linking.

Table 1. Device Symbol Definitions (continued)

Icon Description Definition

Appears in various locations.

Derived parameter algorithm (DPA)

Table 2. Alarm and Status Symbol Definitions

Icon Description Definition

Alarms active for patients

No alarms active No alarms are active on any devices linked to this user’s

Device with active alarm One or more alarms is active on the device indicated by the

Device with active alarm (priority indicated)

Algorithm with active alarm

Algorithm with active alarm (priority indicated)

High priority alarm When shown on the alarm button menu, the message bar on

Represents a derived parameter algorithm linked to a patient in the platform, or available for linking.

Note: Certain algorithms may have their own specific symbols.

Appears in various locations.

Alarms are active for the indicated number of patients.

Note: This symbol does not indicate alarm priority.

Appears on the common navigation bar (alarm button).

patients. Appears on the common navigation bar (alarm button).

icon. (See Table 1 for device icons.)

Note: This symbol does not indicate alarm priority, but only indicates that alarms are active on this device.

Appears in the All Patients and Devices screen. One or more alarms is active on the device indicated by the

icon. (See Table 1 for device icons.) The colored square indicates the priority of the highest-priority alarm currently active on the device. (Alarm priority symbols are explained elsewhere in this table.) Appears on bed tiles in the Tile View, and in the Device Detail screen’s patient header.

The patient is in an alarm condition, according to the derived parameter algorithm (DPA) indicated by the icon.

Note: This symbol does not indicate alarm priority, but only indicates that alarms are active for this algorithm. Note: If an algorithm has its own specific symbol, it will appear instead, with the designator for an alarm or missing data at lower right.

Appears on the All Patients and Devices screen. The patient is in an alarm condition, according to the derived

parameter algorithm indicated by the icon. The colored square indicates the priority of the patient’s alarm state, as defined in the algorithm. (Alarm priority symbols are explained elsewhere in this table.)

Note: If an algorithm has its own specific symbol, it will appear instead, with the designator for an alarm or missing data at lower right.

Appears on bed tiles in the Tile View, and in the Device Detail screen’s patient header.

bed tiles in the Tile View, or in the Device Detail screen’s patient header—The active event with the highest priority on

Table 2. Alarm and Status Symbol Definitions (continued)

Icon Description Definition

the indicated device or for the indicated algorithm is a highpriority alarm.

When shown in other locations—At least one high-priority alarm is active on the indicated device, or the indicated parameter or algorithm is in a high-priority alarm condition.

Medium priority alarm When shown on the alarm button menu, the message bar on

bed tiles in the Tile View, or in the Device Detail screen’s patient header—The active event with the highest priority on the indicated device or for the indicated algorithm is a medium-priority alarm. When shown in other locations—At least one high-priority alarm is active on the indicated device, or the indicated parameter or algorithm is in a medium-priority alarm condition.

Low priority alarm When shown on the alarm button menu, the message bar on

bed tiles in the Tile View, or in the Device Detail screen’s patient header—The active event with the highest priority on the indicated device or for the indicated algorithm is a low- priority alarm. When shown in other locations—At least one high-priority alarm is active on the indicated device, or the indicated parameter or algorithm is in a low-priority alarm condition.

Standard notification When shown on the alarm button menu, the message bar on

bed tiles in the Tile View, or in the Device Detail screen’s patient header—The active event with the highest priority on the indicated device is a notification. (Specifically, this means no alarms are active on any devices or algorithms linked to this patient.) When shown in other locations—At least one notification is active on the indicated device or algorithm.

Unfavorable patient event notification

Favorable patient event notification

Filtered alarm An alarm is active on the indicated device, but the delay

When shown on the alarm button menu, the message bar on bed tiles in the Tile View, or in the Device Detail screen’s patient header—A potentially unfavorable event has occurred for the patient linked to the indicated algorithm. This

requires attention from the user.

When shown in other locations—At least one unfavorable event notification is active on the indicated algorithm.

When shown on the alarm button menu, the message bar on bed tiles in the Tile View, or in the Device Detail screen’s patient header—A favorable event has occurred for the patient linked to the indicated algorithm (for example, completion of an activity related to an algorithm). When shown in other locations—At least one favorable notification is active on the indicated algorithm.

interval before visible and audible annunciation in the platform has not completely elapsed.

Table 2. Alarm and Status Symbol Definitions (continued)

Icon Description Definition

Appears on bed tiles in the Tile View, in the All Patients and Devices screen, and on the parameter tile associated with the alarm in the Device Detail screen.

Device with filtered alarm

Audible alerts silenced in the platform

Audible alarms paused or silenced on a device

Device with audible alarms paused or silenced

Notifications active for patients

One or more alarms that have been filtered (that is, annunciation is delayed or turned off) is active on the device indicated by the icon. (See Table 1 for device icons.)

Note: This symbol does not indicate alarm priority, but only indicates that filtered alarms are active on this device.

Appears on bed tiles in the Tile View, in the All Patients and Devices screen, and (in a slightly different form) in the Device Detail screen’s patient header.

Indicates that the platform’s audible alerts are currently silenced for one or more devices linked to a patient. Appears in the Tile View on the bed tile for the affected patient during the alert silence period.

Indicates that the platform’s audible alerts are currently silenced for the device currently shown in the Device Detail screen. Appears in the Device Detail screen’s patient header (in the color scheme shown) during the alert silence period.

Audible alarms have been paused or silenced at the bedside on a device linked to one of this user’s patients. Appears in various locations.

Indicates that audible alarms have been paused or silenced at the bedside on the indicated device. (See Table 1 for device icons.) Appears on bed tiles in the Tile View, in the All Patients and Devices screen, and (in a slightly different form) in the Device Detail screen’s patient header.

Notifications are active for the indicated number of patients. Appears on the common navigation bar (notification button).

No notifications active No notifications are active on any devices linked to this user’s

patients. Appears on the common navigation bar (notification button).

Setting change on device

Device with active setting changes

Reset alarm on device An alarm on a device linked to one of this user’s patients has

One or more settings have been changed on a device linked to one of this user’s patients. Appears in various locations.

One or more setting change notifications is active on the device indicated by the icon, and has not yet been acknowledged. (See Table 1 for device icons.) Appears in bed tiles on the Tile View, and in the Device Detail screen’s patient header.

reset (i.e., an alarm condition temporarily existed, but has resolved itself without intervention). Appears in various locations.

Table 2. Alarm and Status Symbol Definitions (continued)

Icon Description Definition

Device with reset alarms

Algorithm with standard notification

Unassociated devices available

No unassociated devices

Disconnection A device is not currently communicating with the platform.

Device disconnected The device indicated by the icon is not communicating with

Database connected The platform is currently communicating with its databases.

Database disconnected

One or more reset alarms has occurred on the device indicated by the icon. (See Table 1 for device icons.) Appears on bed tiles in the Tile View, in the Device Detail screen’s patient header, and in the All Patients and Devices screen.

An event has occurred for the patient linked to the algorithm indicated by the icon.

Note: If an algorithm has its own specific symbol, it will appear instead, with the notification designator at lower right.

Appears on bed tiles in the Tile View, and in the Device Detail screen’s patient header.

The indicated number of devices are connected to the platform, but are not currently linked to any patient. Appears in the common navigation bar (device button).

All devices connected to the platform are currently linked to patients. Appears in the common navigation bar (device button).

Appears in various locations. On the Device Detail screen for a disconnected device, this symbol appears in a much larger form.

the platform. Appears on bed tiles on the Tile View, in the Device Detail screen’s patient header, and on the All Patients and Devices screen.

The squares cycle through various colors when a data request is in process. Appears on the common navigation bar, at far right.

Communication between the platform and its databases is currently interrupted. Appears on the common navigation bar, at far right.

Table 3. Miscellaneous User Interface Symbol Definitions

Icon Description Definition

Silence audible alert in the platform

View patient and location information

Denotes the button used to silence alert tones for a specific patient in the platform.

This function does not silence audible alarms on any linked device; those must be silenced on the device itself at the bedside.

Appears on the Device Detail screen’s patient header when alarms are present on the selected device.

Denotes a link to information about the current patient. Appears in the patient header on the Device Detail screen.

Table 3. Miscellaneous User Interface Symbol Definitions (continued)

Icon Description Definition

Edit patient information or location information

Reports Denotes a link to available report functions.

Link new device Denotes the button used to access the Admit Patient screen

Home screen Denotes a link to the current user’s home screen.

Patient type The patient type (from left to right, indicates neonatal, pedia-

Freshness level Denotes the level of confidence in the data used in calcula-

Mark for deletion Denotes the button used to mark alarm rules for deletion.

Search Denotes the button used to search the platform databases

Battery charge For supported devices, shows the current battery charge

Denotes a link to a dialog for editing information about the current patient or location. Appears in the Device Detail screen (patient detail).

Appears in the patient header on the Device Detail screen.

for purposes of linking a new device to a patient. Appears in the patient header on the Device Detail screen.

Appears in the common navigation bar (Home button).

tric, or adult, respectively). The darkened icon indicates the patient type for the patient currently linked to this device. Appears in the device header on the Device Detail screen.

tion of certain derived parameters. Freshness levels shown are 100%, 75%, 50%, 25%, and 0%. The top half of the icon ranges from completely black for the 100% level to completely white for the 0% level. (The icon at left indicates a 50% freshness level.) Appears on the Device Detail screen for the algorithm.

Appears in the Manage Alarm Rules screen next to each custom alarm rule.

for a patient ID number. Appears in the Admit Patient screen and the Update Patient Information window.

level (more black boxes indicate a higher charge level). Appears in the device header on the Device Detail screen.

2.6 Device Types Supported

Note: Medtronic has verified the communication protocols used with the device types listed in this

section.

For more information on communication protocols, see Section 9.4.1, Device Data Reporting, page 183.

The current release of the software supports the following device types:

• Ventilators (including the Puritan Bennett 980 ventilator, Puritan Bennett 840 ventilator, and Newport HT70 ventilator)

• Pulse oximeters (including the Nellcor OxiMax N-595, Nellcor OxiMax N-600x, and Nellcor N-600x-A bedside pulse oximeters, the Nellcor OxiMax N-85 handheld pulse oximeter, and the Nellcor bedside respiratory patient monitoring system)

• Capnography monitoring devices (including the Oridion Capnostream 20 and Oridion Capnostream 20P capnography monitors and the Capnostream 35 portable bedside monitor)

• Regional saturation monitors (including the INVOS 5100C regional saturation patient monitoring system)

• Bispectral index monitors (including the BIS Vista monitoring system)

• Multiparameter monitors (including the Welch Allyn™* Connex™* 6700 (model 67NCTX-B) and Welch Allyn™* Connex™* 6800 (model 68NCTX-B) vital signs monitors)

Also, derived parameter algorithms, if set up and used in the software, will appear in various screens as if they are devices, and can be linked to patients in the same way as devices of the other types listed in this section.

Note: This manual includes only a partial listing of supported device types, and examples of devices supported. Individual facilities may also support additional devices not listed in this manual. Contact the Medtronic Solution Delivery Team for a complete list of devices currently supported.

Note: The term “device type” is replaced in some screens and report output in the software with the term “device category”. For purposes of this manual and the software user interface, the terms are interchangeable.

3 Installation and Access

3.1 Overview

This chapter directs users to the requirements and process for installation of the Vital Sync virtual patient monitoring platform and informatics manager software, and also provides security recommendations for installation and use of the software.

• Section 3.2, System Requirements • Section 3.4, Installation

• Section 3.3, Security Recommendations

3.2 System Requirements

To install and use the software, the systems in question must meet certain hardware and operating system requirements, and must also in some cases have other supporting software installed.

For minimum hardware and software requirements, as well as recommended configurations for best results when using the platform, refer to the installation manual.

For the most current information regarding minimum requirements and recommended configurations, as well as additional installation and configuration information and lists of known and resolved issues, refer to the release notes. Consult with the Medtronic Solution Delivery Team for the most current applicable revision.

3.3 Security Requirements and Recommendations

Cybersecurity risks from using the Vital Sync software have been addressed using a combination of application logic, installation configuration, and particular software and hardware settings. However, using the Vital Sync software does carry some residual risk.

The potential adverse events associated with the residual cybersecurity risks in the Vital Sync software include, but are not limited to, the following:

1. Delay of treatment due to loss of Vital Sync software availability or Vital Sync software data integrity

2. Misdiagnosis due to loss of Vital Sync software data integrity

3. Loss of patient privacy

3.3.1 Required Actions

The following actions are required during installation and software configuration to reduce cybersecurity risks to an acceptable and controlled level:

1. Configure Microsoft™* Windows™* Server to disable weak ciphers. For details, see the following document:

https://docs.microsoft.com/en-us/windows-server/identity/ad-fs/operations/manage-ssl-protoc ols-in-ad-fs

2. Configure Microsoft™* Windows™* Server to enforce NLA authentication for RDP, to reduce the possibility of exploiting the RDP protocol.

3. Configure Microsoft™* Windows™* Server to disable TCP global timestamps on Vital Sync servers.

4. Configure Internet Information Services (IIS) to disable the default IIS home page.

5. Configure IIS to prevent cross-site-scripting attacks.

6. After installation, disable unused Data Collection Service protocol handler listeners to limit the number of open ports.

7. Disable password caching for browsers used to access the Vital Sync software.

8. Configure Microsoft™* SQL Server™* to enable TDE encryption of the MDF file.

9. Disable TLS 1.0 and 1.1, and use TLS 1.2 instead, to protect communication to and from Microsoft™* SQL Server™*.

10. Configure Microsoft™* SQL Server™* to use a signed certificate for encryption, and configure client servers to trust the signed certificate.

11. Configure IIS to require SSL using signed certificates, to force clients to connect using HTTPS. Utilize TLS 1.2, and disable weaker encryption protocols and ciphers.

12. Encrypt Vital Sync service and IIS application configuration files (including connection string files) to prevent unauthorized viewing or modification.

13. Configure the Vital Sync client to always use HTTPS to connect to the InformaticsWeb application. See the installation manual for details.

Consult with the Medtronic Solution Delivery Team and with facility IT personnel for assistance.

3.3.2 Recommended Actions

Medtronic recommends additional practices and procedures to reduce cybersecurity risks to an acceptable and controlled level. Consult with the Medtronic Solution Delivery Team and with facility IT personnel for assistance.

3.3.2.1 Network Configuration

• All medical devices should exist on the same domain.

• Use whitelisting with regard to communication controls across the facility network. Use blacklisting to block unwanted sites.

• Wireless communication should be encrypted where possible.

• Analysis of the overall security configuration of the network should be current.

• Use appropriate third party software to monitor the facility network for suspicious or unauthorized use.

3.3.2.2 Vital Sync Servers and Operating Systems

• The user is responsible for maintaining the operating system software with all current patches and upgrades. Consult facility IT or the Medtronic Solution Delivery Team for details. Medtronic recommends that the operating system server is appropriately configured to optimize cybersecurity.

• The user is responsible for maintaining certain other software components with all current patches and upgrades. Consult facility IT or the Medtronic Solution Delivery Team for details. Medtronic recommends that these components are appropriately configured to optimize cybersecurity.

• If possible, control physical access to the Vital Sync servers and hard drives at the facility.

• Deploy antivirus software on Vital Sync servers.

• Deploy firewall software and configure it to only accept connections from a specific list of IP addresses on Vital Sync servers to specific ports.

• Use appropriate third party security products designed to monitor files or folders for access and modifications and alert security personnel if warranted.

• Make critical BIOS updates according to server vendor hardware and security patch recommendations.

• Change BIOS and system configuration to disable USB ports on systems where the Vital Sync software is installed.

• Configure operating systems on servers to limit user access to the operating system control panel.

• Enable SSH or TLS tunneling.

• Configure Windows™* Remote Desktop Connection to use TLS 1.2 encryption.

• Disable SMB version 1. Enable SMB signing to reduce the possibility of exploiting the SMB protocol.

• Use file structure or disk encryption to protect files on Vital Sync servers.

• Service accounts should use the domain account that is given access to the service, and should not have an administrative role, in order to prevent service dumps containing sensitive information.

• Configure user accounts to lock after multiple subsequent failed login attempts, to prevent brute force attacks.

• Utilize active directory authentication and authorization.

• Do not configure Web browsers to automatically save authentication credentials.

• Disable web page caching in Web browsers used to access the Vital Sync software.

3.3.2.3 Platform Installer

For security considerations related to the installer and additional recommendations included within the installation procedure, see the installation manual or consult with the Medtronic Solution Delivery Team.

3.3.2.4 Database Server Software

• The user is responsible for maintaining the Microsoft™* SQL Server™* software with all current patches and upgrades. Consult facility IT or the Medtronic Solution Delivery Team for details. Medtronic recommends that servers on which Microsoft™* SQL Server™* is installed are appropriately configured to optimize cybersecurity.

• Create and use a new custom account to connect to the database, instead of using the default network service role.

• If possible, use Windows™* authentication instead of mixed mode authentication for Microsoft™* SQL Server™*. For example terminology, see the following document:

https://docs.microsoft.com/en-us/dotnet/framework/data/adonet/sql/authentication-in-sql-server

• Encrypt physical database files using TDE to protect data at rest.

3.3.2.5 Vital Sync Services, IIS Applications, and Device Configuration

• Install the Data Collection, Alarm Reporter, and Applet Manager services on the system where MSMQ is configured.

• Configure MSMQ per active directory user account. It is possible to configure and limit the Data Collection, Applet Manager, and Alarm Reporter services with a Microsoft™* Windows™* domains account with permissions for the MSMQ system. The Data Collection and Applet Manager services should have write permissions; the Alarm Reporter service should have read permission.

• Deploy ECDHE or use a 2048-bit or stronger Diffie-Hellman group.

• Configure IIS to use HTTPS. See the installation manual for details.

• Configure IIS to send the Strict-Transport-Security response header with value “max-age=31536000;”.

• Configure HTTP response headers to nosniff for X-Content-Type-Options in the IIS Admin Console.

• Configure IIS to disable the X-Powered-By and X-AspNet-Version headers.

• During platform installation, set the Alarm Reporter email plugin to use SSL to encrypt communications between the Alarm Reporter and the external SMTP server. (If using SSL, also configure the operating system to use TLS 1.2.)

• Configure the ADT In Adapter Service to only accept connections from a single, specific IP address. (It will then reject connections from any other IP address.)

• Data Collection Service raw protocol handler data file logging is disabled by default. This function should only be enabled temporarily if needed for debugging purposes.

• Configure the DeviceData and InformaticsWeb applications to use HTTPS. See the installation manual for details.

• The Device Data Service only needs to be running during Vital Sync software installation. It can be stopped when installation is complete.

• Vital Sync software users should follow secure password guidelines when creating passwords, to reduce the likelihood of a brute force attack guessing a password.

• Configure any device that does not show its serial number by default in the Vital Sync software to use an inventory tag, to reduce visibility of that device’s IP address in the platform user interface. See Section 6.9.3, Add or Edit a Device, page 136 for more information.

3.4 Installation

For detailed information on installing and configuring platform components and supporting software, refer to the installation manual as well as the release notes for this release of the software, or consult with the Medtronic Solution Delivery Team.

Note: Licenses obtained from Medtronic for installation and use of the Vital Sync virtual patient monitoring platform (including the informatics manager) do not include licenses for any third party software identified in this manual or the installation manual. Users must obtain their own licenses for the downloading and use of such third party software.

+ 210 hidden pages

Medtronic VITALSYNCSW03 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Symbols

Contents

1 Introduction

1.1 Overview

1.2 Conventions

1.3 Applicable Version

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

1.8 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 User Interface Overview

2.4.1 Basic Functions

2.4.2 User Roles

2.5 User Interface Symbols

Table 1. Device Symbol Definitions

Table 2. Alarm and Status Symbol Definitions

Table 3. Miscellaneous User Interface Symbol Definitions

2.6 Device Types Supported

3 Installation and Access

3.1 Overview

3.2 System Requirements

3.3 Security Requirements and Recommendations

3.3.1 Required Actions

3.3.2 Recommended Actions

3.3.2.1 Network Configuration

3.3.2.2 Vital Sync Servers and Operating Systems

3.3.2.3 Platform Installer

3.3.2.4 Database Server Software

3.3.2.5 Vital Sync Services, IIS Applications, and Device Configuration

3.4 Installation