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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.2 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.3 Applicable Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

1.4 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

1.5 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.7 Licensing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.8 HIPAA Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.9 Statement Regarding FDA Clearance of Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.4 User Interface Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

2.5 User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.6 Device Types Supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

3 Installation and Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.2 System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.3 Security Requirements and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.4 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.2 Access the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.3 Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

4.4 Clinician Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

4.5 Supervisor Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

4.6 Administrator Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.7 Functions for Other Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5 Clinician and Supervisor Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.2 Alarms and Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.3 Navigation and Basic User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.4 Tile View (Patient Overview Screen) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

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

5.6 All Patients and Devices Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

5.7 Admit a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

5.8 Manual Parameter Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

5.9 Discharge (Remove) a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

5.10 Patient Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

5.11 Area Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

5.12 Select User Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

5.13 Event List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

5.14 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

5.15 Change Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

5.16 Audible Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

5.17 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

5.18 Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

5.19 Platform Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

6.5 Manage Monitoring Station Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

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, Notication, and Setting Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

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

6.13 Manage Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

6.14 Manage Algorithms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

6.15 Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

6.16 Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

6.17 Version Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

6.18 Platform Logout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

7 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

7.2 Summary of Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

7.3 Clear Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

7.4 Audible Alerts and Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

7.5 View Alarm Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

7.6 Filtered Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

7.7 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

7.8 Alarm Behavior in the Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

8 Notications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

8.2 Summary of Notication Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

8.3 View Notication Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

8.4 View and Acknowledge Setting Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

8.5 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Appendix A Supplementary Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

A.2 Alarm Communication from Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

A.3 Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

A.4 Alarm Functionality and Behavior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

A.5 Alarm Rule Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182

A.6 Event Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

A.7 Default Alarm Priority by Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

A.8 Audible Alert Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186

A.9 Device Auto-Reconnection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187

A.10 Device Data Handling After Unlinking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

A.11 Admission, Discharge, and Transfer (ADT) Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

A.12 Web API Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Appendix B Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

B.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

B.2 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

B.3 Report Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

B.4 Clinician and Supervisory Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

B.5 Administrative Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Figures

Figure 1. Login Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Figure 2. Common Navigation Bar (Standard) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 3. Function Menu (Clinician) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 4. Function Menu (Supervisor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Figure 5. Alarm Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Figure 6. Notication Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Figure 7. Device Button Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Figure 8. Example Function Drop-Down Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Figure 9. Example System Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Figure 10. Tool Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Figure 11. Patient Overview Screen (Tile View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Figure 12. Bed Tile Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Figure 13. Device Tile Detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Figure 14. Bed Tile (patient name masked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

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

Figure 16. Device Detail Screen Layout (Philips™* V60 and V60 Plus ventilators) . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Figure 17. Device Detail Screen Layout (pulse oximeter or capnography monitor) . . . . . . . . . . . . . . . . . . . . . . . . 56

Figure 18. Device Detail Screen Layout (derived parameter algorithm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Figure 19. Patient Header Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 20. Patient Header Panel (alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Figure 21. Device Header Panel (ventilator) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 22. Device Header Panel (pulse oximeter or capnography monitor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 23. Device Header Panel (regional saturation monitor) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 24. Parameter Panel (ventilator data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 25. Parameter Panel (Philips™* V60 or V60 Plus ventilator data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Figure 26. Parameter Panel (pulse oximeter data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

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

Figure 28. Parameter Panel (bispectral index monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Figure 29. Parameter Panel (multiparameter monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 30. Parameter Panel (four-channel regional saturation monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 31. Parameter Panel (two-channel regional saturation monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 32. Waveform Panel (ventilator data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Figure 33. Waveform Panel (pulse oximeter data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Figure 34. Waveform Panel (capnography monitor data) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Figure 35. Settings Panel (ventilator settings) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Figure 36. Figure 37. Figure 38. Figure 39. Figure 40. Figure 41. Figure 42. Figure 43. Figure 44. Figure 45. Figure 46. Figure 47. Figure 48. Figure 49. Figure 50.

Figure 51. Tile View (device tile dragged onto bed tile at lower left) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Figure 52. Admit Patient Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Figure 53. Admit Patient Screen (available device list) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Trend Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Event Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Parameter Trend Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Parameter Trend Window (alarm and setting change icons and alarm message shown) . . . . . . . . 69

Parameter Trend Window (specic data point shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Waveform Detail Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Waveform Detail Window (specic data shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Waveform Detail Window (specic data shown for multiple ventilator waveforms) . . . . . . . . . . . . . 71

Device Detail Screen (patient information elds) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Update Patient Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Update Patient Location Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Rules and Settings Dialog (example delay rules shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Rules and Settings Dialog (example alert thresholds shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

All Patients and Devices Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

All Patients and Devices Screen (assignments shown for a patient) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Figure 54. Link New Device/Algorithm dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Figure 55. Device Detail Screen (making a device primary) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

Figure 56. Device Detail Screen (device disconnected from the platform) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Figure 57. Replace Linked Device Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Figure 58. Device Detail Screen (manual discharge) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Figure 59. Patient Discharge History Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

Figure 60. Patient Assignment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

Figure 61. Patient Assignment Screen (unassigned patients shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Figure 62. Patient Assignment Screen (other user selected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Figure 63. Patient Assignment Screen (other user’s assignments) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Figure 64. Patient Assignment Screen (shift menu shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Figure 65. Area Assignment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Figure 66. Area Assignment Screen (unassigned areas shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Figure 67. Area Assignment Screen (other user selected) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Figure 68. Area Assignment Screen (other user’s assignments) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

Figure 69. Area Assignment Screen (shift menu shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Figure 70. Select User Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Figure 71. Navigation Bar and Function Menu (Select User Mode) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Figure 72. Event List Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Figure 73. Device Detail Screen (Patient Reports tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

Figure 74. Change Password Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Figure 75. Audible Alerts Dialog (control of alerts locked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Figure 76. Audible Alerts Dialog (control of alerts unlocked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Figure 77. Version Information (About) Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Figure 78. Figure 79. Figure 80. Figure 81. Figure 82. Figure 83. Figure 84. Figure 85. Figure 86. Figure 87. Figure 88. Figure 89. Figure 90. Figure 91. Figure 92.

Figure 93. Manage Monitoring Station Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Figure 94. Manage Monitoring Station Accounts Screen (inactive accounts shown) . . . . . . . . . . . . . . . . . . . . . 122

Figure 95. Edit Monitoring Station Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Example Administrative Navigation Links . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Example System Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

Column Sort (cursor and heading to be sorted shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

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

Manage User Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

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

Create User Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Edit User Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

User Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

User Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

User Account Deletion Conrmation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

User Account Unlock Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Password Reset Conrmation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Password Reset Conrmation Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Change Password Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Figure 96. Monitoring Station Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Figure 97. Monitoring Station Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Figure 98. Manage Bedside Display Accounts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Figure 99. Manage Bedside Display Accounts Screen (inactive accounts shown) . . . . . . . . . . . . . . . . . . . . . . . . 126

Figure 100. Edit Bedside Display Account Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

Figure 101. Bedside Display Account Deactivation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Figure 102. Bedside Display Account Activation Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Figure 103. Manage Shifts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Figure 104. Add Shift Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

Figure 105. Edit Shift Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Figure 106. Manage Areas Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Figure 107. Add Areas Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Figure 108. Edit Area Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Figure 109. Manage Beds Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Figure 110. Add Bed Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Figure 111. Edit Bed Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Figure 112. Manage Device Inventory Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Figure 113. Add Device Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Figure 114. Edit Device Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Figure 115. Device Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

Figure 116. Device Detail Window (General tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Figure 117. Device Detail Window (Support tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Figure 118. Manage Rule Sets Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Figure 119. Add Rule Set Screen (Alarm Rules tab) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Figure 120. Figure 121. Figure 122. Figure 123. Figure 124. Figure 125. Figure 126. Figure 127. Figure 128. Figure 129. Figure 130. Figure 131. Figure 132. Figure 133. Figure 134.

Figure 135. Silence Button (alerts silenced) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Figure 136. Bed Tile (platform alert silence indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Figure 137. Bed Tile (device alarm pause or silence indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

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

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

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

Custom Alarm Rule Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

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

Alarm Rules Tab (custom rule deletion) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Manage Alerts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Alert Edit Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Manage Parameters Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Upload Parameter Denitions Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

Manage Algorithms Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Add Algorithm Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

Version Information (About) Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Common Navigation Bar (alarms indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Silence Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Figure 138. Patient Header Panel (device alarm pause or silence indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Figure 139. Bed Tile (alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Figure 140. Bed Tile (secondary alarm indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Figure 141. Patient Header (active alarm indicated on device) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Figure 142. Parameter Panel (alarm indicators shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Figure 143. Parameter Trend Window (alarm message shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Figure 144. Event Panel (alarms and durations shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Figure 145. Alarm Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Figure 146. Bed Tile (ltered alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Figure 147. Bed Tile (secondary alarm indicator shown for ltered alarm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Figure 148. Patient Header (ltered alarm indicated on device) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 149. Parameter Panel (ltered alarm indicated for parameter) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 150. Event Panel (ltered alarm message shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Figure 151. Filtered Out Alarm Information Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Figure 152. Common Navigation Bar (notications indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

Figure 153. Bed Tile (reset alarm indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Figure 154. Bed Tile (setting change indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Figure 155. Bed Tile (device disconnection indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Figure 156. Bed Tile (informational notication indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Figure 157. Bed Tile (unfavorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Figure 158. Bed Tile (favorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Figure 159. Bed Tile (secondary notication indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Figure 160. Patient Header (standard notication indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Figure 161. Patient Header (unfavorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Figure 162. Figure 163. Figure 164. Figure 165. Figure 166. Figure 167. Figure 168. Figure 169. Figure 170. Figure 171. Figure 172. Figure 173. Figure 174. Figure 175. Figure 176.

Figure 177. Alarm Threshold Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

Figure 178. Device Usage Hours Per Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Figure 179. Device Utilization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Patient Header (favorable patient event indicated) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Parameter Panel (reset alarm indicator shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Settings Panel (changed settings shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

Unacknowledged Settings Changes Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Patient Reports Tab in Device Detail Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Reports Screen (including example selection buttons and output) . . . . . . . . . . . . . . . . . . . . . . . . . . 190

Calendar Drop-Down Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

Time Drop-Down Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Comprehensive Oximetry and Capnography Report (initial page) . . . . . . . . . . . . . . . . . . . . . . . . . . . 195

Comprehensive Oximetry and Capnography Report (comparison summary) . . . . . . . . . . . . . . . . 196

Oxygenation Snapshot Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Reported Apneas Per Hour Report (12-hour output shown) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Ventilation Snapshot Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Alarm Duration by Time of Day Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Alarm Occurrence Pareto Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Figure 180. Highest Frequency Setting Changes Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Figure 181. Monitored Patients Per Day Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Figure 182. Alarm Normalization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Figure 183. Alarm Rule Set Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Figure 184. Subscription Utilization Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

Figure 185. Application Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Figure 186. Connectivity Details Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Figure 187. Connectivity Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

Figure 188. DPA Usage Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Figure 189. Historical Performance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

Tables

Table 1. Device Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Table 2. Alarm and Status Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Table 3. Miscellaneous User Interface Symbol Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Table 4. Visual Alarm Indicators (normal alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Table 5. Visual Alarm Indicators (ltered or silenced alarms) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Table 6. Alarm Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Table 7. Visual Notication Indicators (device-related) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Table 8. Visual Notication Indicators (informational) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Table 9. Notication Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

Table 10. Device Communication Rules and Disconnect Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Table 11. Event Priority Ranking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

Table 12. Device and Algorithm Priority Ranking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

Table 13. Default Automatic Reconnection Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Table 14. Reports Available to Clinicians and Supervisors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Table 15. Comprehensive Oxygenation and Capnography Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Table 16. Oxygenation Snapshot Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

Table 17. Reported Apneas Per Hour Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

Table 18. Ventilation Snapshot Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

Table 19. Alarm Duration by Time of Day Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

Table 20. Alarm Occurrence Pareto Chart Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Table 21. Alarm Threshold Analysis Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

Table 22. Device Usage Hours Per Patient Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Table 23. Device Utilization Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213

Table 24. Highest Frequency Setting Changes Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214

Table 25. Monitored Patients Per Day Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

Table 26. Reports Available to Administrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

Table 27. Alarm Rule Set Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222

Table 28. Subscription Utilization Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224

Table 29. Application Event Log Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Table 30. Connectivity Details Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Table 31. Connectivity Summary Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

Table 32. DPA Usage Summary Report Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

Table 33. Historical Performance Log Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

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 eective 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, eld names, and report eld names appear in

• “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 specied, “device” refers to patient devices (for example, pulse oximeters, ventilators, or capnography monitors), access and perform functions in the software.

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

• “Event” refers both to alarms and notications from devices and algorithms.

to smartphones, tablets, or optional dedicated bedside display units used to

not

boldface

text.

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 fullled 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 ctitious, 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 3.1 of the Vital Sync virtual patient monitoring platform and informatics manager.

Users can view specic 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 dierent priority on dierent 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 dierent 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 notications in the platform, especially for devices that are life-sustaining. Because notications do not audibly annunciate, setting an alarm as a notication may cause users to not respond or delay in responding to a clinically signicant event.

•

Warning: Notications from connected devices should not be set as alarms in the platform, especially for events not requiring clinical intervention. Setting a notication as an alarm may create nuisance audible alerts that are not clinically signicant.

•

Warning: If using audible alerts, ensure the sound volume of the PC or mobile device on which the software is used is sucient 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 modication 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

specications.

•

Note: The platform’s data and audible alerts (including those appearing on optional dedicated bedside display units) are informational. Except as specied 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 notications.

•

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 103 and Section B.5, Administrative Reports, page 217 for details.

•

Note: The platform has been veried on systems using Microsoft™* Windows™* and Windows™*-based software. User experience may vary with other operating systems and hardware and software congurations.

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

Manseld, 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 specications, 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 tness for a particular purpose. Medtronic shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

1.7 Licensing Information

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 identied 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 condentiality of all data created, stored or transmitted on their systems. See Section 3.3, Security Requirements and Recommendations, page 29.

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, Contraindications • 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 notication 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 specic 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 specic beds in the facility, and to dene areas in the platform that correspond with specic locations (also sometimes referred to as zones or areas of care) within the facility. Areas are assignable to specic 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 rene the timing of alarm and notication annunciation in the platform, also known as alarm ltering; 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 ltered 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 specic 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-specic account specically 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 specied 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 27 for a list of specic 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 identied 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 specic 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 congure 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.

•

2.5 User Interface Symbols

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

Note: Some symbols may appear in dierent 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 dierent color scheme than is shown here.

Table 1. Device Symbol Denitions

Icon Description Denition

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 platform, or

available for linking. Appears in various locations.

Bispectral index (BIS) mon‐ itor

Regional saturation moni‐ tor

Multiparameter monitor Represents a multiparameter monitor linked to a patient in the

Derived parameter algo‐ rithm (DPA)

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.

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

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

Note: Certain algorithms may have their own specic sym‐ bols.

Appears in various locations.

Table 2. Alarm and Status Symbol Denitions

Icon Description Denition

Alarms active for patients Alarms are active for the indicated number of patients.

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

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

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 bed

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

Note: This symbol does not indicate alarm priority.

Appears on the common navigation bar (alarm button).

(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 specic 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 dened in the algorithm. (Alarm priority symbols are explained elsewhere in this table.)

Note: If an algorithm has its own specic 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.

tiles in the Tile View, or in the Device Detail screen’s patient head‐ er—The active event with the highest priority on the indicated device or for the indicated algorithm is a high-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 high-priority alarm condition.

tiles in the Tile View, or in the Device Detail screen’s patient head‐ er—The active event with the highest priority on the indicated device or for the indicated algorithm is a medium-priority alarm.

Table 2. Alarm and Status Symbol Denitions (continued)

Icon Description Denition

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 head‐ er—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 notication 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 head‐ er—The active event with the highest priority on the indicated device is a notication. (Specically, this means no alarms are active on any devices or algorithms linked to this patient.) When shown in other locations—At least one notication is active on the indicated device or algorithm.

Unfavorable patient event

notication

Favorable patient event

notication

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

Device with ltered alarm One or more alarms that have been ltered (that is, annunciation

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 notication 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 notica‐ tion is active on the indicated algorithm.

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

is delayed or turned o) 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 ltered 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 dierent form) in the Device Detail screen’s patient header.

Table 2. Alarm and Status Symbol Denitions (continued)

Icon Description Denition

Audible alerts silenced in the platform

Audible alarms paused or silenced on a device

Device with audible alarms paused or silenced

Notications active for pa‐ tients

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 aected 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 dierent form) in the Device Detail screen’s patient header.

Notications are active for the indicated number of patients. Appears on the common navigation bar (notication button).

No notications active No notications are active on any devices linked to this user’s

patients. Appears on the common navigation bar (notication button).

Setting change on device One or more settings have been changed on a device linked to

one of this user’s patients. Appears in various locations.

Device with active setting changes

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

Device with reset alarms One or more reset alarms has occurred on the device indicated

Algorithm with standard

notication

Unassociated devices available

One or more setting change notications 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.

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

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 specic symbol, it will appear instead, with the notication 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).

Table 2. Alarm and Status Symbol Denitions (continued)

Icon Description Denition

No unassociated devices All devices connected to the platform are currently linked to

patients. Appears in the common navigation bar (device button).

Disconnection A device is not currently communicating with the platform.

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

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

Database connected The platform is currently communicating with its databases.

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

Database disconnected Communication between the platform and its databases is cur‐

rently interrupted. Appears on the common navigation bar, at far right.

Table 3. Miscellaneous User Interface Symbol Denitions

Icon Description Denition

Silence audible alert in the platform

View patient and location information

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 for

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

Denotes the button used to silence alert tones for a specic 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.

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.

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).

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

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.

Table 3. Miscellaneous User Interface Symbol Denitions (continued)

Icon Description Denition

Freshness level Denotes the level of condence in the data used in calculation 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.

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

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

Search Denotes the button used to search the platform databases for a

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

Battery charge For supported devices, shows the current battery charge 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 veried the communication protocols used with the device types listed in this section.

For more information on communication protocols, see Section A.4.1, Device Data Reporting, page 181.

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

• Ventilators (including the Puritan Bennett 980 ventilator, Puritan Bennett 840 ventilator, Newport HT70 ventilator, and Philips™* V60 and V60 Plus ventilators)

• 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 (models 67NCTX-B and 67NXTX-B) and Welch Allyn™* Connex™* 6800 (models 68NCTX-B and 68NXTX-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 Requirements and Recom‐ mendations

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 congurations for best results when using the platform, refer to the installation manual.

For the most current information regarding minimum requirements and recommended congurations, as well as additional installation and conguration 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 conguration, 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 conguration to reduce cybersecurity risks to an acceptable and controlled level:

1. Congure 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-protocols-in-a

d-fs

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

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

4. Congure Internet Information Services (IIS) to disable the default IIS home page.

5. Congure 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. Congure Microsoft™* SQL Server™* to enable TDE encryption of the MDF le.

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

10. Congure Microsoft™* SQL Server™* to use a signed certicate for encryption, and congure client servers to trust the signed certicate.

11. Congure IIS to require SSL using signed certicates, 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 conguration les (including connection string les) to prevent unauthorized viewing or modication.

13. Congure 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 Conguration

• 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 conguration 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 congured 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 congured 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 rewall software and congure it to only accept connections from a specic list of IP addresses on Vital Sync servers to specic ports.

• Use appropriate third party security products designed to monitor les or folders for access and modications and alert security personnel if warranted.

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

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

• Congure operating systems on servers to limit user access to the operating system control panel.

• Enable SSH or TLS tunneling.

• Congure 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 le structure or disk encryption to protect les on Vital Sync servers.

+ 206 hidden pages

Medtronic VITALSYNCSW03 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

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

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

3.3.2.2 Vital Sync Servers and Operating Systems