Medtronic PM7100_Operaters_Manual_en_PT00097962B00 INVOS Patient Monitor Operator’s Manual

Operator’s Manual

INVOS

Patient Monitor

©2019 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

1 Introduction

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.3.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.3.2 Explosion, Shock, and Toxicity Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.3.3 Patient Monitoring and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.3.4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

1.3.5 Sensors, Cables, and Other Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

1.3.6 Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

1.3.7 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

1.4.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

2 Product Overview

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

2.4 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.4.1 Full System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.4.2 Monitor Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

2.5 Product and Carton Label Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

3 Installation

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.3 Unpacking and Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

3.4 Power Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.4.1 AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.4.2 Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

3.5 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

3.5.1 Install the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

3.5.2 Insert the Monitor into the Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

3.5.3 Connect the Preamplifier(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-11

3.5.4 Connect the Reusable Sensor Cables (RSCs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

3.5.5 Apply Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-13

3.5.6 Set Institutional Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16

3.5.7 Power Off the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

3.5.8 Position the Monitoring System in the Clinical Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

Operator’s Manual iii

Table of Contents

4 Operation

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.3 Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

4.4 Operational Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

4.5 Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

4.6 Monitoring System Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

4.7 Set Up for Patient Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

4.8 Optional Set-Up Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

4.8.1 Changing the Sensor Placement Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16

4.8.2 Repositioning On-Screen Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

4.8.3 Assigning or Modifying the Patient ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-19

4.8.4 Changing the On-Screen Sensor Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-21

4.8.5 Changing the Screen Brightness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-23

4.9 Baselines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

4.10 Trend View Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

4.10.1 About the Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28

4.10.2 Changing the Trend View - Two Graphs or One Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29

4.10.3 Turning Trend Line Averaging On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30

4.10.4 Zooming the Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.10.5 Reviewing Data that has Scrolled Off the Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-32

4.10.6 Viewing Previous rSO2 Values on the Trend Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-33

4.11 Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

4.11.1 Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-35

4.11.2 Setting Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-38

4.11.3 Changing the Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-40

4.11.4 Silencing or Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-41

4.11.5 Dismissing an Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-43

4.12 Event Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

4.12.1 About Event Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-44

4.12.2 Marking Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-45

4.12.3 Viewing an Event Mark Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-45

4.12.4 Renaming an Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-46

4.12.5 Changing the Event List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-47

4.13 Area Under the Curve (AUC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49

4.13.1 About Area Under the Curve (AUC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-49

4.13.2 Changing the AUC Threshold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-50

4.13.3 Resetting AUC Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-51

4.14 Finish Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-51

4.15 Case Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-52

4.15.1 About Case Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-52

4.15.2 Viewing Case Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-52

4.15.3 Exporting Case Histories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-55

iv Operator’s Manual

Table of Contents

5 Data Management

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.3 Displaying Monitoring System Screens on an External Monitor . . . . . . . . . . . . . . . . . 5-2

5.4 Downloading Case Histories to a USB Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.5 Transmitting Monitoring System Data to External Devices via the Serial Port . . . . 5-3

5.5.1 Serial Port Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

5.5.2 Transmitting Real-Time Data to a Philips IntelliBridge™* and VueLink™*

Open Interface (IVOI) Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

5.5.3 Transmitting Case Data to a Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6

5.6 Data Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

5.6.1 Case Histories Downloaded via USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8

5.6.2 Case Data Downloaded via Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10

5.6.3 Event Codes for Data Downloads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13

5.6.4 Status Codes for Data Downloads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17

6 Performance Considerations

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.3 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

6.4 Sensor Use Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

6.5 EMI (Electromagnetic Interference) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

7 Product Maintenance

7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.3 Cleaning the Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

7.3.1 Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

7.3.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.4 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.5 Service and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

7.6 Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

7.7 Software and Firmware Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

7.8 Recycling and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

8 Alarms and Troubleshooting

8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.2 Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

8.3 Error Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

8.4 Product Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

Operator’s Manual v

Table of Contents

9 Accessories

9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

9.2 Safety Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

9.3 Accessories/Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

10 Theory of Operations

10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

10.2 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

11 Product Specifications

11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

11.2 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2

11.3 Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

11.4 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3

11.5 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

11.6 Alarm Audio and Visual Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

11.6.1 Alarm Audio Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

11.6.2 Alarm Visual Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

11.6.3 POST Pass Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-6

11.7 Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

11.8 Equipment Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

11.9 Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

11.10 Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-7

11.10.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9

11.11 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14

A Clinical Studies

A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

A.2 Hypoxia Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

A.3 Interventional Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

A.4 Validation Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

vi Operator’s Manual

List of Tables

Table1-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Table2-1. Label Symbol Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Table3-1. Monitoring System - Standard Shipped Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Table3-2. AC Power Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Table3-3. Battery Status Indicators - Monitoring System Operating on Battery Power . . . . . . . . . . . 3-6

Table3-4. Institutional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Table4-1. Quick Start Steps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Table4-2. Operational Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Table4-3. Menu Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Table4-4. System Memory - Common Situations and Recommended Actions . . . . . . . . . . . . . . . . . 4-10

Table4-5. Alarm Audio Button States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Table4-6. Audible and Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Table4-7. Alarm Limits Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

Table5-1. Serial Port Pin-Out Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Table5-2. Hardware Requirements for Philips VueLink™* and IntelliBridge™* Communication . . . 5-5

Table5-3. Case History Downloads - Data Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Table5-4. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields . . . . . . . . . . . . . . . . . . . . . . . 5-12

Table5-5. Data Downloads - Event Codes 1 to 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13

Table5-6. Data Downloads - Event Codes 41 to 80. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14

Table5-7. Data Downloads - Event Codes 81 to 120 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Table5-8. Data Downloads - Event Codes 121 to 254 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16

Table5-9. Data Downloads - Status Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17

Table7-1. Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Table8-1. Alarm Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Table8-2. Error Conditions and Resolutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Table9-1. Monitoring System Accessory Part Numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Table11-1. Transport, Storage, and Operating Condition Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-4

Table11-2. Alarm Audio Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5

Table11-3. Average Alarm Sound Pressure Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Table11-4. Alarm Visual Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5

Table11-5. POST Pass Tone Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

Table11-6. INVOS™ Adult rSO

Table11-7. Electromagnetic Emissions Guidelines and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-9

Table11-8. Electromagnetic Immunity Guidelines and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-10

Table11-9. Recommended Separation Distance Calculations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-11

Table11-10. Test Specifications for Enclosure Port Immunity to RF Wireless Communications

Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-13

Table11-11. Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-14

TableA-1. Performance Characteristics: Accuracy Bias, Error (SD), RMSD, and Correlation (R

for rSO

and fSO2, 20 Subjects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

TableA-2. Trend Bias, Error (SD), and Correlation (R

Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6

)

) for ΔrSO2 and ΔfSO2, 20 subjects . . . . . . . . . .A-3

Operator’s Manual vii

Page Left Intentionally Blank

viii

List of Figures

Figure1-1. Start-up Screen Showing Code Version. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Figure2-1. INVOS™ Patient Monitor Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Figure2-2. Monitor - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Figure2-3. Monitor - Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Figure2-4. Monitor - Right Side. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Figure2-5. Monitor - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Figure2-6. Docking Station - Bottom View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Figure2-7. Docking Station - Connector for Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Figure2-8. Sample Monitoring Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Figure3-1. Power Input Connection at Bottom of Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Figure3-2. Docking Station Power Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Figure3-3. Battery Location at Back of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Figure3-4. Battery Slot and Latch at Back of Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Figure3-5. Battery Installed in Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Figure3-6. Monitor Mounted in Docking Station. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Figure3-7. Connecting the Preamplifier Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

Figure3-8. Connecting the RSC to the Preamplifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Figure3-9. Power Input Connection at Bottom of Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Figure3-10. Power Button on Top of Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14

Figure3-11. Set-Up Screen - Preamplifier(s) Connected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Figure3-12. Set-Up Screen - No Preamplifier(s) Connected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Figure3-13. Monitoring System on Stand with Preamplifier Hung on Rail . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Figure4-1. Set-Up Screen - Prompt for Sensor Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Figure4-2. Monitoring Screen - New Case - No Baselines Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Figure4-3. Default Sensor Placement Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Figure4-4. Optional Sensor Placement Sequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-17

Figure4-5. Highlighting an On-Screen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Figure4-6. Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient) . . . . . . . . . . . 4-18

Figure4-7. Patient Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Figure4-8. Entering a Patient ID Before Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Figure4-9. Patient Icon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Figure4-10. Entering a Patient ID During Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21

Figure4-11. Sensor Label Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Figure4-12. SETTINGS - GENERAL - SCREEN BRIGHTNESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Figure4-13. Monitoring Screen - New Data Set - No Baselines Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-25

Figure4-14. SET BASELINES - No Baselines Previously Set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

Figure4-15. SET BASELINES - Baselines Previously Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Figure4-16. Monitoring Screen with Baselines Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27

Figure4-17. Trend View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

Figure4-18. Trend View - One Graph (Left, Default) and Two Graphs (Right) . . . . . . . . . . . . . . . . . . . . . .4-29

Figure4-19. SETTINGS - TRENDS - TWO AXIS VIEW vs. ONE AXIS VIEW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30

Figure4-20. Trend Line Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Figure4-21. SETTINGS - TRENDS - TREND LINE AVERAGING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31

Operator’s Manual ix

List of Figures

Figure4-22. Trend View Review Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33

Figure4-23. Trend Graph Pop-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Figure4-24. Monitoring Screen - Trend Graph Pop-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Figure4-25. Visual Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-36

Figure4-26. SET ALARM LIMITS - Default Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Figure4-27. SET ALARM LIMITS - Upper Limits On. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Figure4-28. SETTINGS - ALARMS - ALARM VOLUME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-41

Figure4-29. Dismissible Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

Figure4-30. Events Marked in Trend View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Figure4-31. ADD EVENT Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45

Figure4-32. Event Mark Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-46

Figure4-33. EDIT EVENT Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-47

Figure4-34. SETTINGS - EVENTS (Screen 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48

Figure4-35. AUC SUMMARY Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49

Figure4-36. CASE HISTORY List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-53

Figure4-37. Case History Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-54

Figure5-1. VGA Port on Docking Station. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Figure5-2. Serial Port on Docking Station. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Figure5-3. Serial Port Pin-Outs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Figure5-4. Null Modem Cable Diagram for Connection to Serial Port (Two Options) . . . . . . . . . . . . . 5-7

FigureA-1. Accuracy rSO FigureA-2. Trend rSO

and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

x Operator’s Manual

1 Introduction

1.1 Overview

This manual contains information for operating the INVOS™ patient monitor (the “monitoring system”).

This manual applies to the following product:

PM7100

• Intended Audience, page 1-1

• Safety Information, page 1-2

• Obtaining Technical Assistance, page 1-7

• Warranty Information, page 1-9

1.2 Intended Audience

This manual provides information to health-care professionals in a hospital setting for operation and maintenance of the monitoring system. Refer to the institution for any additional training or skill requirements beyond those identified here for operation and maintenance of the monitoring system.

Before operating the monitoring system, carefully read this manual, the Instructions for Use for the accessories, and all precautionary information and specifications.

1-1

Introduction

Safety Information

1.3

This section contains important safety information for use of the monitoring system.

1.3.1 Safety Symbols

Table1-1.Safety Symbol Definitions

Symbol Definition

WARNING

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

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

Note

Notes provide additional guidelines or information.

1.3.2 Explosion, Shock, and Toxicity Hazards

 WARNING:

Explosion hazard — Do not use the monitoring system in the presence of flammable anesthetics.

 WARNING:

Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See Accessories/Parts List, page 9-2.

 WARNING:

Shock hazard — Ensure the monitoring system is properly grounded when operating on AC power.

 WARNING:

Shock hazard — When connecting the monitoring system to any instrument, verify proper operation before clinical use. Any equipment connected to the data interface must be certified according to the latest IEC/EN 60950-1 standard for data-

1-2 Operator’s Manual

processing equipment, the latest IEC/EN 60601-1 standard for electromedical equipment, or the latest IEC/EN safety standards relevant to that equipment. All combinations of equipment must be in compliance with Requirements for Medical Electrical Systems within IEC/EN Standard 60601-1. Anyone who connects equipment to the data interface is configuring a medical system and, therefore, is responsible for ensuring the system complies with the Requirements for Medical Electrical Systems IEC/EN Standard 60601-1 and the electromagnetic compatibility IEC/EN Standard 60601-1-2. Performance may degrade if it is connected to secondary I/O devices when the equipment is not connected to earth reference.

 WARNING:

Toxicity hazard — The LCD panel (screen) contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances.

1.3.3 Patient Monitoring and Safety

Safety Information

 WARNING:

The monitoring system should not be used as the sole basis for diagnosis or therapy. It is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

 WARNING:

Always disconnect and remove the monitoring system and sensors during magnetic resonance imaging (MRI) scanning. Attempting to use the monitoring system during an MRI procedure could cause burns or adversely affect the MRI image or the monitoring system's performance.

 WARNING:

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

 WARNING:

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

 WARNING:

Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

Operator’s Manual 1-3

Introduction

 WARNING:

 Caution:

An external multi-parameter system will not generate an alarm or error message if remote communication between the multi-parameter system and the monitoring system has been broken. During this period of no remote communication, the monitoring system will continue to monitor, generate alarms, and display status messages. The multi-parameter system operator should not rely on the multiparameter system for generating alarms.

Choking hazard — The reusable sensor cables (RSCs) include a strain-relief clip that, if detached, may pose a choking hazard.

If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.

1.3.4 Operation

 WARNING:

Inspect the monitoring system and all accessories before use to ensure there are no signs of physical damage or improper function. Do not use if damaged.

 WARNING:

If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative.

 WARNING:

Monitoring system readings can be affected by certain patient conditions. Refer to

Patient Conditions, page 6-2.

 WARNING:

Explosion hazard — When replacing the battery, do not use the incorrect type. Use only the battery available from Medtronic. See Accessories/Parts List, page 9-2.

 WARNING:

To ensure proper performance, avoid shock, and prevent device damage or failure, do not expose the monitoring system to extreme moisture, such as direct exposure

1-4 Operator’s Manual

to rain. Do not immerse in water, solvents, or cleaning solutions, since the monitoring system and connectors are not waterproof.

 Caution:

Dispose of the battery in accordance with local guidelines and regulations.

1.3.5 Sensors, Cables, and Other Accessories

 WARNING:

The use of accessories, sensors, and cables other than those specified may result in poor performance of the monitoring system and increased electromagnetic emissions or decreased electromagnetic immunity of the monitoring system.

 WARNING:

Failure to cover the sensor site with opaque material when operating under high ambient light conditions may result in poor performance.

Safety Information

 Caution:

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

1.3.6 Electromagnetic Interference

 WARNING:

Electromagnetic emissions from the monitoring system may interfere with other critical devices.

 WARNING:

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitoring system, including cables. Otherwise, degradation of monitoring system performance may result.

 WARNING:

Operator’s Manual 1-5

Introduction

 WARNING:

The monitoring system is intended for use by healthcare professionals only. It may cause radio interference or may disrupt the operation of nearby equipment. Mitigation for such disruption may require re-orienting or relocating the monitoring system or shielding the location.

Any radio frequency transmitting equipment or other nearby sources of electrical noise may result in disruption of the monitoring system.

The monitoring system is designed for use in environments in which the signal can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the monitoring system may not seem to operate correctly.

 WARNING:

EMI disruption can cause cessation of operation or other incorrect functioning.

 WARNING:

The monitoring system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, observe the monitoring system to verify normal operation in the desired configuration. Technical alarms may indicate that the configuration is not appropriate for the monitoring system.

 Caution:

This device has been tested and found to comply with the limits for medical devices related to IEC 60601-1-2: 2007 and IEC 60601-1-2:2014. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

 Caution:

When operating medical electrical equipment, special precautions related to electromagnetic compatibility (EMC) are required. Install the monitoring system according to the EMC information included in this manual.

1-6 Operator’s Manual

 Caution:

The monitoring system generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. If interference is suspected, move monitoring system cables away from the susceptible device.

 Caution:

The use of an electrosurgical or electrocautery instrument in the vicinity of the monitoring system may interfere with the signal and cause poor performance or no readings at all.

1.3.7 Cleaning

Obtaining Technical Assistance

 Caution:

Do not autoclave or gas sterilize any components of the monitoring system.

 Caution:

To prevent device damage or failure, do not expose the monitor to isopropyl alcohol.

1.4 Obtaining Technical Assistance

1.4.1 Technical Services

For technical information and assistance, contact Medtronic or a local Medtronic representative.

Medtronic Technical Services

5870 Stoneridge Drive, Suite 6

Pleasanton, CA 94588 USA

1.800.635.5267 or 1.925.463.4635

or contact a local Medtronic representative

www.medtronic.com

When calling Medtronic or a local Medtronic representative, have the monitoring system serial numbers and software versions available. Serial numbers are located

Operator’s Manual 1-7

Introduction

on the back of the monitor and the preamplifiers. The software version for the monitoring system is displayed on the start-up screen at power-on.

Figure1-1.Start-up Screen Showing Code Version

 Note:

An authorized technician can view serial numbers and software versions through the monitoring system’s service mode. Refer to the monitoring system’s service manual.

1.4.2 Related Documents

• INVOS™ Adult rSO

about sensor selection and use.

• INVOS™ Preamplifier Instructions for Use — Provides instructions for connecting

the monitoring system’s preamplifiers.

• INVOS™ Patient Monitor Service Manual —

nicians for use when servicing the monitoring system.

Sensor Instructions for Use —

Provides information to authorized tech-

Provides important information

1-8 Operator’s Manual

Warranty Information

1.5

To obtain product warranty information, contact Medtronic or a local Medtronic representative. See Technical Services, page 1-7.

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

Warranty Information

Operator’s Manual 1-9

Introduction

Page Left Intentionally Blank

1-10 Operator’s Manual

2 Product Overview

2.1 Overview

This chapter contains basic information about the INVOS™ patient monitor (the “monitoring system”).

• Product Description, page 2-1

• Indications for Use, page 2-2

• Product Views, page 2-3

• Product and Carton Label Symbols, page 2-13

2.2 Product Description

The monitoring system provides continuous, noninvasive indications of changes in regional oxygen saturation of blood (rSO

) in cerebral and somatic tissues.

The monitoring system consists of:

• A tablet-style monitor that can be operated on AC or battery power

• A VESA™* docking station for the monitor, with USB, Serial (RS-232), and VGA ports

• An AC power supply and cord that attaches to the docking station

• Up to two preamplifiers to accommodate up to four sensors (two per preamplifier)

• Up to four reusable sensor cables (RSCs) to attach sensors to the preamplifiers

• INVOS™ rSO

• Additional accessories as described in Accessories, page 9-1

sensors

2-1

Product Overview

Monitoring system features include:

• User configurable rSO

olds (page 4-49)

• Physiological and technical alarm reporting (page 8-2)

baselines (page 4-24), alarm limits (page 4-38), and AUC thresh-

• User configurable data display (rSO

, change from baseline, sensor labels, and trend

data) (page 2-10)

• Alarm silencing (page 4-41)

• Event marking (page 4-44)

• Visual representations of sensor locations (page 4-17)

• Sensor functional state (page 8-2):

- Sensor off

- Sensor disconnect

- Sensor fault

• Case history storage and export (page 4-52)

• Real-time data output to external devices such as a Philips multi-parameter system or

PC (page 5-3)

• VGA, Serial (RS-232), and USB interfaces (pages 2-5, 2-8)

2.3 Indications for Use

The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals greater than 40 kg at risk for reduced-flow or no-flow ischemic states.

2-2 Operator’s Manual

Product Views

2.4

2.4.1 Full System

System Component Overview

Product Views

Figure2-1.INVOS™ Patient Monitor Components

1 Sensors 4 Monitor

2 Preamplifier 5 Reusable sensor cable (RSC)

3 Docking station

Operator’s Manual 2-3

Product Overview

2.4.2

Monitor Components

Monitor - Front

Figure2-2.Monitor - Front

VESA

™

*-compliant stand accessory

2 Power cord (connected to

bottom of docking station)

3 Docking station 6 Docking station power indicator (illuminates blue

2-4 Operator’s Manual

4 Monitor indicators (power/battery, hard disk activ-

ity, wireless)

5 Monitor

when the docking station is receiving AC power)

Monitor - Left Side

Product Views

Figure2-3.Monitor - Left Side

1 Lever for adjusting monitor angle 4 USB 2.0 port

2 I/O port cover with latch (slide to access ports inside) 5 Docking station

3 USB 3.0 port

Operator’s Manual 2-5

Product Overview

Monitor - Right Side

Figure2-4.Monitor - Right Side

1 Docking station 3 Lever for adjusting monitor angle

2 Connector for preamplifier (x2)

2-6 Operator’s Manual

Monitor - Back

Product Views

Figure2-5.Monitor - Back

1 Docking station 4 Programmable buttons (not used)

2 Connectors for preamplifiers 5 Lever for adjusting monitor angle

3 Power button 6 Speaker

Operator’s Manual 2-7

Product Overview

Docking Station

Figure2-6.Docking Station - Bottom View

1 Power input connection (DC in jack) 4 Serial port (RS-232)

2 LAN port (not used, disabled) 5 USB 2.0 port (x2)

3 VGA port

2-8 Operator’s Manual

Figure2-7.Docking Station - Connector for Monitor

Product Views

1 Docking station 2 Connector for monitor

Operator’s Manual 2-9

Product Overview

Monitoring Screen

Figure2-8. Sample Monitoring Screen Elements

1 Message area Provides information about alarm conditions. The background indicates the

severity of the condition. If alarm audio is silenced, an alarm audio silenced symbol appears next to the alarm message. See Alarm Management, page 4-

35. If a “?” appears next to the alarm message, press the “?” for additional information.

N/A Dismiss button

(not shown)

2 Sensor icons Each sensor icon has a label indicating its location on the patient. See Chang-

3 Date and time Current date in MM/DD/YYYY format (by default) and current time in 12-

2-10 Operator’s Manual

Available in the message area when an alarm is dismissible. See Dismissing

an Alarm, page 4-43.

ing the On-Screen Sensor Labels, page 4-21.

hour HH:MM:SS format (by default). The date and time format can be changed by an authorized technician.

Product Views

4 Battery status

indicator

Indicates the remaining battery capacity:

• Charged battery —

The level in the icon decreases as battery power

is used.

• Low battery —

A medium-priority alarm occurs when the monitoring system is operating on battery power and the battery has a charge of <33% remaining. The alarm message BATTERY LOW appears.

• Critically low battery —

A medium-priority alarm occurs when the monitoring system is operating on battery power and the battery has a charge of <5% remaining. The alarm message BATTERY CRITICALLY LOW appears. When no charge remains, the monitoring system automatically shuts down.

Battery charging indicator

AC power indicator

Indicates that the monitoring system is connected to AC power and the battery is charging.

When the battery is fully charged and the monitoring system remains connected to AC power, the AC power indicator replaces the battery charging indicator.

6 CURRENT The most recent rSO2 reading from each sensor.

7 CHANGE The percent change between the current rSO

reading and the established

baseline for each sensor, color-coded to the corresponding sensor icon.

8 Sensor/readings in

alarm state

If a sensor alarm or loss of readings occurs, the corresponding sensor is highlighted on the screen. If readings are lost, the CURRENT and CHANGE values are replaced by dashes. Check the message area for information about the condition.

9 Alarm limits The current alarm limits for each sensor, color-coded to the corresponding

sensor icon. A horizontal red line indicates each alarm limit in the trend view graph. See Setting Alarm Limits, page 4-38.

10 Event mark Event marks indicate significant occurrences during monitoring. Event marks

can be added to the trend graph at any time during monitoring and are displayed as vertical lines with flags. See Event Marks, page 4-44.

11 Baseline values The current rSO

baseline established for each tissue region being moni-

tored, color-coded to the corresponding sensor icon. Dotted lines in the trend view graph also indicate the baseline values, color-coded to the corresponding sensor icon. See Baselines, page 4-24.

Operator’s Manual 2-11

Product Overview

12 Alarm Audio button Indicates whether alarm audio is on, silenced, or paused. Press to silence or

pause alarm audio or to turn alarm audio back on. When an alarm occurs and alarm audio is silenced or paused, the button’s color corresponds to the highest-level alarm. See Alarm Indicators, page 4-35, and Silencing or Pausing

Alarms, page 4-41.

13 MARK EVENT

button

Press to add an event mark to the trend graph to indicate a significant occurrence during monitoring. Choose from a customizable list of events. See

Event Marks, page 4-44.

14 Patient button While monitoring, press to return to the Set-up screen, reposition on-screen

sensors, or assign or modify a patient ID. See Set Up for Patient Monitoring, page 4-11, Repositioning On-Screen Sensors, page 4-17, and Assigning or Mod-

ifying the Patient ID, page 4-19.

15 Trend view The trend view shows the progression of rSO

case. Data is color-coded to the corresponding sensor icon. rSO

values over the course of a

values are

presented on the vertical (y) axis. Time is presented on the horizontal (x) axis. See Trend View Management, page 4-27.

16 MENU button Press to access a variety of settings and functions depending on whether or

not sensors are connected and monitoring has begun. See Menu Structure, page 4-9.

2-12 Operator’s Manual

Product and Carton Label Symbols

2.5

Table2-1.Label Symbol Descriptions

Symbol Description Symbol Description

Reference code (part number) Serial number

Product and Carton Label Symbols

Lot number

Prescription only US federal law restricts this device to

sale by or on the order of a physician

Manufacturer Date of manufacture

Fragile Keep dry

Must consult instructions for use Consult instructions for use

Atmospheric pressure limits (see Envi-

ronmental Conditions, page 11-4)

Humidity limits (see Environmental

Conditions, page 11-4)

European Community (EC) authorized representative

Protection against fluid ingress: Protected against vertically falling water drops when tilted to 15º

Temperature limits (see Environmental

Conditions, page 11-4)

Proper waste disposal for electrical and electronic equipment

MR unsafe - Do not use during magnetic resonance imaging

CSA – Canadian Standards Association certification mark

Not made with natural rubber latex

Operator’s Manual 2-13

Defibrillation-proof type BF applied part

CE – Conformité Européene authorization mark

0123 – TÜV SÜD Product Service GmbH (notified body)

Electromagnetic interference may occur in the vicinity of equipment marked with this symbol

Product Overview

Table2-1.Label Symbol Descriptions (Continued)

Symbol Description Symbol Description

Quantity included in package (example: 20)

Do not immerse

2-14 Operator’s Manual

3 Installation

3.1 Overview

This chapter contains information for the installation and set up of the INVOS™ patient monitor (the “monitoring system”) prior to first-time use.

• Safety Reminders, page 3-1

• Unpacking and Inspection, page 3-2

• Power Options, page 3-3

• Setup, page 3-7

3.2 Safety Reminders

 WARNING:

Inspect the monitoring system and all accessories before use to ensure there are no signs of physical damage or improper function. Do not use if damaged.

 WARNING:

Shock hazard — Ensure the monitoring system is properly grounded when operating on AC power.

 WARNING:

If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative.

 Caution:

3-1

Installation

 Caution:

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

3.3 Unpacking and Inspection

The monitoring system ships in multiple cartons. Upon receipt of the monitoring system, examine the cartons for evidence of damage. Contact Medtronic Technical Services immediately if a carton appears damaged. See Technical Services, page 1-7.

Standard items shipped are listed in Table3-1. Quantities of some items may vary based on customer requirements. Check all items for any sign of damage.

If you need to return the monitoring system for any reason, contact Medtronic Technical Services. See

Technical Services, page 1-7

 Note:

Save the cartons and packing material for any future transport.

Table3-1.Monitoring System - Standard Shipped Items

Item Quantity

Patient monitor 1

Lithium-ion battery 1

Patient monitor stand 1

VESA

™*

docking station

Preamplifiers 1 or 2

Reusable sensor cables (RSCs) 2 or 4

INVOS

™

adult rSO2 sensors

AC power supply 1

Power cord 1

Operator’s manual (on USB flash drive)

1. The manual may be printed from the included USB drive. Order a printed Operator’s Manual or Service Manual

from Medtronic Technical Services or your local Medtronic representative. See Technical Services, page 1-7.

Box of 5, 10, or 20

3-2 Operator’s Manual

Power Options

3.4

The monitoring system operates on AC power or on a rechargeable internal battery. Medtronic recommends operating the monitoring system on AC power whenever possible. Use battery power only when necessary, such as while moving the patient within the facility or during AC power interruptions.

3.4.1 AC Power

 WARNING:

Shock hazard — Ensure the monitoring system is properly grounded when operating on AC power.

The power input connection for the monitoring system is at the bottom of the docking station. Always use the provided AC power cord and power supply.

Power Options

Figure3-1.Power Input Connection at Bottom of Docking Station

Operator’s Manual 3-3

Installation

When the power supply is connected to the AC outlet and the docking station, the power indicator on the docking station illuminates blue (Figure 3-2).

Figure3-2.Docking Station Power Indicator

3-4 Operator’s Manual

AC power to the monitoring system is indicated as follows:

Table3-2.AC Power Indicators

Status Monitor LED Screen icon

AC connected (battery charging)

AC connected (battery fully charged)

Power Options

AC not connected

3.4.2 Battery Power

 Note:

Whenever the monitoring system is connected to AC power, the battery will charge as needed.

The monitoring system includes a rechargeable lithium-ion battery located in the back of the monitor.

One of the following, depending on battery charge level. See Table 3-3, page 3-6.

Operator’s Manual 3-5

Installation

Figure3-3.Battery Location at Back of Monitor

Medtronic strongly recommends using AC power during continuous operation. Use battery power only when necessary, such as during transport within a facility. If the monitoring system is operating on battery power, alarms are generated if the battery reaches low or critical levels. When the battery is depleted, the monitoring system shuts down immediately.

Battery Status Indicators

If using the monitoring system on battery power, be sure to frequently check the battery status (Table 3-3).

Table3-3.Battery Status Indicators - Monitoring System Operating on Battery Power

Battery status Screen icon Audible alarm Message

Charged (33% - 100% remaining)

Low (<33% remaining)

Critically Low (<5% remaining)

N/A N/A

Medium priority

BATTERY LOW

BATTERY CRITICALLY LOW

Malfunctioning Low priority - no

audible alarm

3-6 Operator’s Manual

BATTERY FAILURE

Battery Life

 Caution:

Dispose of the battery in accordance with local guidelines and regulations.

For maximum battery reliability, replace the battery on a regular basis. Medtronic recommends replacing the battery once every 2 years. If the battery will not sustain monitoring for more than approximately 1 hour when fully charged, replace the battery immediately.

Contact Medtronic or a local Medtronic representative for information about obtaining replacement batteries.

3.5 Setup

See

Technical Services, page 1-7.

Setup

Use the following instructions to prepare the monitoring system for first use. See

Operation, page 4-1 for additional steps to be performed by the clinician when mon-

itoring a patient.

• Install the Battery, page 3-7

• Insert the Monitor into the Docking Station, page 3-9

• Connect the Preamplifier(s), page 3-11

• Connect the Reusable Sensor Cables (RSCs), page 3-12

• Apply Power, page 3-13

• Set Institutional Defaults, page 3-16

• Power Off the Monitoring System, page 3-17

• Position the Monitoring System in the Clinical Setting, page 3-17

3.5.1 Install the Battery

The monitoring system’s lithium-ion battery is shipped with the monitor, but not installed. Install and fully charge the battery prior to clinical use (see Apply Power, page 3-13 for charging information).

To install the battery:

1. Remove the battery from its packaging.

Operator’s Manual 3-7

Installation

2. At the back of the monitor, make sure that the battery latch, located above the battery

slot, is to the right (Figure 3-4).

Figure3-4.Battery Slot and Latch at Back of Monitor

1 Battery 3 Battery latch

2 Battery slot

3. Insert the battery into the slot, bottom edge (with three tabs) first.

4. With the battery completely inserted, slide the battery latch to the left to lock the

battery in place (Figure 3-5).

3-8 Operator’s Manual

Figure3-5.Battery Installed in Monitor

Setup

3.5.2 Insert the Monitor into the Docking Station

The docking station is intended to hold the monitor during typical use of the monitoring system. You can mount the docking station on the provided stand or on other VESA™*-compatible equipment capable of supporting at least 5.1 lb (2.3 kg) (VESA™* FDMI MIS-D, 75).

Monitor stand use: If you intend to use the monitor stand, attach the docking station to the stand using the provided hardware. Refer to the instructions provided with the monitor stand.

To insert the monitor into the docking station:

1. Align the connector at the bottom of the monitor with the connector in the docking

station (Figure 3-6).

2. Press the monitor down into the docking station until the connectors engage. Pegs and

guide holes in the docking station and monitor ensure proper alignment.

3. Press the monitor back into the clip at the top of the docking station until it fully engag-

es.

Operator’s Manual 3-9

Installation

Figure3-6.Monitor Mounted in Docking Station

3-10 Operator’s Manual

3.5.3

Connect the Preamplifier(s)

 Caution:

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

To connect the preamplifier(s) to the monitor:

1. Align the red dot on the preamplifier cable connector with the red marking on the

monitor input connection (Figure 3-7).

Setup

Figure3-7.Connecting the Preamplifier Cable

2. Insert the cable connector directly upward into the connection until the locking sleeve

rotates and clicks into place.

3. Repeat steps if using a second preamplifier.

 Note:

To disconnect a preamplifier cable from the monitor, grasp the locking sleeve and rotate it in the direction indicated by the arrow while pulling downward.

Operator’s Manual 3-11

Installation

3.5.4

Connect the Reusable Sensor Cables (RSCs)

Each preamplifier allows connection of up to two sensors via reusable sensor cables (RSCs). Using two preamplifiers, the monitoring system can accommodate up to four RSCs and four sensors.

To connect the RSCs:

1. Align the RSC’s male connector with the connection slot on the preamplifier. The con-

nector and slot are keyed to guide insertion.

2. Press firmly until the connector snaps into place. Ensure that the clip on the connector

engages completely with the connection slot.

Figure3-8.Connecting the RSC to the Preamplifier

3. Repeat these steps for each RSC to be used.

4. Coil and secure the RSC cabling to avoid tangling.

3-12 Operator’s Manual

3.5.5

Apply Power

 WARNING:

If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative.

Before applying power, refer to Power Options, page 3-3 to understand the requirements for using AC power and battery power.

To power on the monitoring system:

1. Ensure that the AC outlet is properly grounded and supplies the specified voltage and

frequency. See Electrical, page 11-3 for voltage and frequency specifications.

2. Connect the power supply to the power input connection on the bottom of the

docking station.

Setup

Figure3-9.Power Input Connection at Bottom of Docking Station

3. Connect the AC power cord to the power supply and the AC outlet. Verify that the blue

power indicator on the docking station is illuminated (Figure 3-2 on page 3-4).

The battery indicator at the top left of the monitor indicates the charge status. The battery will charge as necessary when the monitoring system is connected to AC power.

Charging

Fully charged

4. Press the Power button on top of the monitor.

Operator’s Manual 3-13

Installation

Figure3-10.Power Button on Top of Monitor

While the monitoring system performs its power-on self-test (POST), a progress bar appears at the bottom of the screen.

5. Ensure that the POST pass tone sounds when POST completes. See POST Pass Tone,

page 11-6 for tone specifications.

The POST pass tone is an audible confirmation of proper speaker performance. If the speaker does not function, alarm warning sounds will not be audible.

Once POST is complete, the Set-up screen appears (Figure 3-11).

3-14 Operator’s Manual

Figure3-11.Set-Up Screen - Preamplifier(s) Connected

Setup

 Note:

If no preamplifiers are connected to the monitoring system, the screen prompts you to connect them (Figure 3-12). See Connect the Preamplifier(s), page 3-11.

 Note:

Make sure that the battery is fully charged prior to clinical use. Table 3-2, page 3-5, describes the charging status indicators.

Figure3-12.Set-Up Screen - No Preamplifier(s) Connected

Operator’s Manual 3-15

Installation

3.5.6

Set Institutional Defaults

Table 3-4 describes the institutional settings available for the monitoring system.

Institutional defaults must be set by an authorized technician. Refer to the monitoring system's service manual. Refer to Table 4-2 on page 4-7 for information about additional options that can be set or changed by the clinician.

Table3-4.Institutional Settings

Item Available settings Factory default

Silence alarms at startup

Alarm audio off/pause duration

Alarm reminder signal

Line frequency 50 Hz, 60 Hz

POST during sensor off ON, OFF

Date (Select from calendar)

Date format DD MM YYYY, YYYY MM DD, MM DD

Time (Select hh:mm)

Time format 24 hr, 12 hr

Language DANISH, DUTCH, ENGLISH, FRENCH,

YES, NO NO - Alarms will sound unless the user

INDEFINITE, 2 MINS INDEFINITE - When silenced by the

ON, OFF

YYYY

GERMAN, GREEK, HUNGARIAN, ITALIAN, NORWEGIAN, POLISH, PORTUGUESE, ROMANIAN, RUSSIAN, SLOVAK, SPANISH, SWEDISH

presses the Alarm Audio button

user, alarms remain silent until the user unsilences them

OFF

60 Hz

OFF For system diagnostics only. Do not

set to ON when used in a clinical setting.

Coordinated Universal Time (UTC)

MM DD YYYY

N/A

12 hr

ENGLISH

Serial port OFF, PC LINK 1, PC LINK 2, CLINICAL

TEST SETUP, VUE LINK

3-16 Operator’s Manual

OFF

3.5.7

Power Off the Monitoring System

To power off the monitoring system:

Press the Power button on top of the monitor.

2. Observe that the screen goes completely dark. The battery indicator on the monitor and

the power indicator on the docking station remain illuminated as long as power is connected.

3.5.8 Position the Monitoring System in the Clinical Setting

 WARNING:

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

Setup

Users may choose from a variety of mounting configurations, including the provided monitor stand or other VESA™*-compatible mounting options capable of supporting at least 5.1 lb (2.3 kg) (VESA™* FDMI MIS-D, 75). In addition, the preamplifiers have a fold-away swivel hook for attachment to rails or poles (Figure 3-13).

Figure3-13.Monitoring System on Stand with Preamplifier Hung on Rail

Operator’s Manual 3-17

Installation

Be sure to consider the following when positioning the monitoring system:

• Docking station use — The docking station is intended to hold the monitor during

typical use and provides the power connection for the monitoring system. Make sure the docking station is accessible at all times. See Insert the Monitor into the Docking Sta-

tion, page 3-9.

• Monitor stand use — When using the monitor stand, place the stand on a sturdy flat

surface. Use the lever on the back of the stand to adjust the angle of the monitor for best visibility.

• Power outlet access and power cord position — Ensure that the power outlet used

for the monitoring system is easily accessible.

• Cable routing — Position the monitoring system for ease of access to all cabling. You

can use the fold-away hooks on the preamplifiers to hang them from rails or poles. Ensure that cables are routed so that there is no risk of patient entanglement or strangulation.

• Monitor access and visibility — Ensure that the operator can easily access and view

the monitor while monitoring. Choose a location that allows visual communication of rSO

values and alarms. See Physical Characteristics, page 11-2 for visibility specifications.

3-18 Operator’s Manual

4 Operation

4.1 Overview

This chapter explains how to use the INVOS™ patient monitor (the “monitoring system”) to view and collect patient regional oxygen saturation (rSO

This chapter assumes that the monitoring system has been installed at the location of use and tested by the institution. See Installation, page 3-1 for full installation instructions.

• Safety Reminders, page 4-2

• Quick Start, page 4-5

• Operational Defaults, page 4-7

• Menu Structure, page 4-9

• Monitoring System Memory, page 4-9

) data.

• Set Up for Patient Monitoring, page 4-11

• Optional Set-Up Tasks, page 4-16

• Baselines, page 4-24

• Trend View Management, page 4-27

• Alarm Management, page 4-35

• Event Marks, page 4-44

• Area Under the Curve (AUC), page 4-49

• Finish Monitoring, page 4-51

• Case Histories, page 4-52

4-1

Operation

Safety Reminders

4.2

 WARNING:

Inspect the monitoring system and all accessories before use to ensure there are no signs of physical damage or improper function. Do not use if damaged.

 WARNING:

Explosion hazard — Do not use the monitoring system in the presence of flammable anesthetics.

 WARNING:

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

 WARNING:

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

 WARNING:

Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

 WARNING:

If you do not hear a tone at system start-up, discontinue use of the monitoring system and contact Medtronic or a local Medtronic representative.

4-2 Operator’s Manual

 WARNING:

Monitoring system readings can be affected by certain patient conditions. Refer to

Patient Conditions, page 6-2.

 WARNING:

Failure to cover the sensor site with opaque material when operating under high ambient light conditions may result in poor performance.

 WARNING:

Electromagnetic emissions from the monitoring system may interfere with other critical devices.

 WARNING:

Safety Reminders

 WARNING:

Any radio frequency transmitting equipment or other nearby sources of electrical noise may result in disruption of the monitoring system.

 WARNING:

Operator’s Manual 4-3

Operation

 WARNING:

EMI disruption can cause cessation of operation or other incorrect functioning.

 WARNING:

 Caution:

If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.

 Caution:

Make sure all connectors are fully engaged and free from moisture. Moisture intrusion may cause poor performance or no readings at all.

 Caution:

The use of an electrosurgical or electrocautery instrument in the vicinity of the monitoring system may interfere with the signal and cause poor performance or no readings at all.

Refer to Safety Information, page 1-2 for additional warnings and cautions regarding use of the monitoring system.

4-4 Operator’s Manual

Quick Start

4.3

If you are familiar with operating the monitoring system, follow the steps in Table 4-

1 to set up the device and monitor a patient. Be sure you have reviewed the infor-

mation in Safety Reminders, page 4-2 before monitoring a patient.

If you are not familiar with operating the monitoring system, carefully read all instructions in this chapter, beginning with Set Up for Patient Monitoring, page 4-11.

Table4-1.Quick Start Steps

Make sure all components of the monitoring system are present:

Monitor, docking station, power supply, power cord, preamplifier(s), reusable sensor cables (RSCs), INVOS™ rSO

sensors

Attach up to four INVOS™ rSO2 sensors to the patient

See Set Up for Patient Monitoring, page 411

See the Instructions for Use provided with the sensors

Quick Start

Power on the monitoring system See Set Up for Patient Monitoring, page 4-

Optionally, change the sensor placement sequence See Changing the Sensor Placement

Sequence, page 4-16

Connect the sensors to the RSCs, following the onscreen prompts, and verify the sensor locations

Secure all cables to avoid patient skin injury or entanglement

Optionally, enter a patient ID See Assigning or Modifying the Patient ID,

Begin monitoring:

- For a new case, press NEW DATA SET

- To continue a case, press APPEND OLD DATA

Set baselines

Press MENU, SET BASELINES

10 Set or change alarm limits, as desired

Press MENU, ALARM LIMITS

Optionally, change the trend view:

- Number of graphs

- Trend-line averaging

- Time scale

See Set Up for Patient Monitoring, page 411

page 4-19

See Set Up for Patient Monitoring, page 411

See Baselines, page 4-24

See Setting Alarm Limits, page 4-38

See Trend View Management, page 4-27

Operator’s Manual 4-5

Operation

Table4-1.Quick Start Steps (Continued)

12 Optionally, change the on-screen sensor labels See Changing the On-Screen Sensor Labels,

page 4-21

13 Optionally, check and modify the list of event

markers

14 Optionally, change Area Under the Curve (AUC)

thresholds

Optionally, adjust the screen brightness See Changing the Screen Brightness, page

Optionally, adjust the alarm volume See Changing the Alarm Volume, page 4-40

Respond to alarms, as necessary:

- Alarm indicators

- Alarm message lookup

- Silence or pause alarms

- Dismiss alarms

Mark events, as desired See Event Marks, page 4-44

Finish monitoring See Finish Monitoring, page 4-51

See Changing the Event List, page 4-47

See Changing the AUC Threshold, page 450

4-23

See:

- Alarm Indicators, page 4-35

- Alarm Messages, page 8-2

- Silencing or Pausing Alarms, page 4-41

- Dismissing an Alarm, page 4-43

4-6 Operator’s Manual

Operational Defaults

4.4

The following table lists default settings for the monitoring system. Some of these settings can be changed by the user, while others require authorized access, as indicated.

Table4-2.Operational Defaults

Item Available settings Default

Upper alarm limits OFF, ON OFF

See Setting Alarm Limits, page 4-38

Lower alarm limits MANUAL, AUTO MANUAL

See Setting Alarm Limits, page 4-38

Operational Defaults

Upper rSO

Lower rSO

Silence alarms at startup

Alarm audio off/ pause duration

Alarm reminder signal ON, OFF OFF - No reminder when alarms are silenced

Line frequency 50 Hz, 60 Hz 60 Hz

limit 20 - 95 If ON, default is 90

See Setting Alarm Limits, page 4-38

limit MANUAL: 15 - 90

AUTO: 5 - 30

YES, NO

INDEFINITE, 2 MINS

MANUAL: 40 AUTO: 20 See Setting Alarm Limits, page 4-38

NO - Alarm audio is on by default, but alarm audio may be silenced or paused by the user. See

Silencing or Pausing Alarms, page 4-41.

This setting may be changed by an authorized technician.

INDEFINITE - When silenced, alarms remain silent until the user unsilences them. See Alarm Silence

Duration, page 4-42.

This setting may be changed by an authorized technician.

Alarm volume 1 - 10 5

See Changing the Alarm Volume, page 4-40

Screen brightness 1 - 10 7

See Changing the Screen Brightness, page 4-23

Operator’s Manual 4-7

Operation

Table4-2.Operational Defaults (Continued)

Item Available settings Default

Time format 24 hr, 12 hr 12 hr

This setting may be changed by an authorized technician.

Date format DD MM YYYY, YYYY MM DD,

MM DD YYY

Language Danish, Dutch, English,

French, German, Greek, Hungarian, Italian, Norwegian, Polish, Portuguese, Romanian, Russian, Slovak, Spanish, Swedish

Trend line averaging ON, OFF OFF

Trend axis view TWO AXIS VIEW, ONE AXIS

VIEW

Trend time scale (x-axis)

Sensor placement sequence

AUC threshold type FIXED

1, 2, 4, 8, 12, 24 hours

4, 3, or 2 sensors 4 sensors

% BELOW BASELINE

MM DD YYYY This setting may be changed by an authorized

technician.

English This setting may be changed by an authorized

technician.

See Turning Trend Line Averaging On/Off, page 430

ONE AXIS VIEW See Changing the Trend View - Two Graphs or One

Graph, page 4-29

1 hour See Zooming the Trend View, page 4-32

See Changing the Sensor Placement Sequence, page 4-16

FIXED See Changing the AUC Threshold, page 4-50

AUC threshold FIXED: 30 - 60

% BELOW BASELINE: 0 - 30%

Serial port OFF, PC LINK 1, PC LINK 2,

CLINICAL TEST SETUP, VUE LINK

4-8 Operator’s Manual

FIXED: 50 % BELOW BASELINE: 25% See Changing the AUC Threshold, page 4-50

OFF This setting may be changed by an authorized

technician.

Menu Structure

4.5

MENU ALARM LIMITS UPPER LIMITS

Menu Structure

Table4-3.Menu Structure

LOWER LIMITS

SETTINGS GENERAL SCREEN BRIGHTNESS

SENSOR PLACEMENT SEQUENCE

ALARMS ALARM VOLUME

TRENDS TREND LINE AVERAGING

TWO AXIS VIEW/ONE AXIS VIEW

EVENTS

CASE HISTORIES

SET BASELINES

AREA UNDER CURVE

1. Available only when no sensors are connected to the monitoring system.

2. Available only when monitoring has begun.

4.6 Monitoring System Memory

RESET AUC

THRESHOLD

The monitoring system stores the following information about the current case in memory:

• Case ID

• Current baselines (value and time baselines were obtained)

• Current sensor positions:

– The monitoring system remembers the last sensors that were connected, the loca-

tions they were assigned (for example, left cerebral), and their last baseline values.

– The monitoring system also remembers the last reusable sensor cable (RSC) and

preamplifier port assignments (for example, which RSC and preamplifier the left cerebral sensor was connected to).

Operator’s Manual 4-9

Operation

The previously used sensor location overrides the last RSC/preamplifier port assign-

–

ment. For example, if you plug what was the right cerebral sensor into what was the left cerebral RSC/preamplifier port, it will show up on screen as the right cerebral sensor.

Because the monitoring system retains this information for an ongoing case, you can disconnect sensors from the system and reconnect the same sensors without having to reassign sensor locations or perform the sensor set-up routine.

Table 4-4 describes some common situations, the actions you should perform, and

how the system reacts.

Table4-4.System Memory - Common Situations and Recommended Actions

When this situation occurs... Perform this action...

You have started monitoring a patient but notice that you have the sensor locations swapped.

Sensors need to be disconnected from the monitoring system during a case (for example, to reroute the cables).

The monitoring system is powered off and back on during a case

A case has ended. Unplug and discard all sensors that were used during the case.

Navigate to the sensor Set-up screen (see Repositioning On-Screen

Sensors, page 4-17), drag and drop the sensors to the correct loca-

tions on the screen, confirm the new locations, then press APPEND OLD DATA to resume monitoring.

Disconnect and reconnect the affected sensors. The monitoring system automatically assigns the sensors back to the proper locations.

No action is necessary. The monitoring system automatically assigns sensors to the proper location and resumes monitoring.

Dismiss the “Sensor Not Connected” alarm. The monitoring system returns to the Set-up screen.

4-10 Operator’s Manual

Set Up for Patient Monitoring

4.7

The following steps assume you are ready to begin monitoring a patient in a surgical setting or other hospital environment. Be sure you have reviewed the information in

Safety Reminders, page 4-2 before monitoring a patient.

To set up the monitoring system:

1. Make sure all components of the monitoring system are present:

• Monitor

• Docking station - Recommended for extended monitoring.

• Power supply and power cord - AC power is recommended for extended moni-

toring. You can use battery power briefly, if necessary, such as when transporting a patient between locations within a hospital.

• Preamplifiers - Use one or two preamplifiers, depending on the number of sites to

be monitored. Each preamplifier accommodates two sensors. If no preamplifiers are connected, see Connect the Preamplifier(s), page 3-11 for instructions.

• Reusable sensor cables (RSCs) - Use one RSC per sensor, up to two per preampli-

fier. If no RSCs are connected, see Connect the Reusable Sensor Cables (RSCs), page 312, for instructions.

• INVOS™ rSO

sensors - Before use, carefully read the sensor Instructions for Use,

including all warnings, cautions, and instructions.

2. Determine the sites you will monitor on the patient. Select the correct type of INVOS™

rSO

sensor for your patient; do not mix sensor types. Attach up to four sensors to the

patient. Refer to the Instructions for Use provided with the sensors for application instructions.

3. Power on the monitoring system:

a. Make sure that the monitoring system’s power supply is plugged into the docking

station and a properly grounded hospital mains outlet (see AC Power, page 3-3). You may operate the monitoring system briefly on battery power if necessary, but AC power is recommended for extended monitoring. See Power Options, page 3-3 for additional information about powering the monitoring system.

b. Press the Power button on top of the monitor (see Apply Power, page 3-13). If oper-

ating on battery power, check the battery status indicator on the screen to determine whether the battery needs charging (see Table 3-3, page 3-6).

Operator’s Manual 4-11

Operation

c. Ensure that the POST pass tone sounds when POST completes. See POST Pass Tone,

page 11-6 for tone specifications.

The POST pass tone is an audible confirmation of proper speaker performance. If the speaker does not function, alarm warning sounds will not be audible.

Once POST is complete, the Set-up screen appears (Figure 4-1).

Figure4-1.Set-Up Screen - Prompt for Sensor Connection

4. Optionally, you can set the sensor sequence for the number of sensors you are using. If

you are using fewer than four sensors, you can set the number to three or two for onscreen representations. See Changing the Sensor Placement Sequence, page 4-16.

5. Connect the RSCs to the sensors that have been applied to the patient:

 Caution:

If two sensors are placed in close proximity to each other on a patient, the same preamplifier should be connected to both sensors to avoid poor performance.

a. Note the highlighted sensor location on screen (Figure 4-1). Locate the correspond-

ing sensor applied to the patient.

b. Look for the flashing blue light on the preamplifier and at the end of the corre-

sponding RSC.

c. Align the sensor’s male connector with the connection slot on the RSC. The connec-

tor and slot are keyed to guide insertion.

d. Press firmly until the connector snaps into place. The monitoring system indicates

proper connection by displaying an rSO

reading at the corresponding sensor loca-

4-12 Operator’s Manual

e. Look for the next highlighted sensor location on screen and the next flashing blue

f. Repeat these steps for each sensor applied to the patient.

g. Verify the placement of all sensors by briefly pressing each on-screen sensor loca-

 Note:

As you connect the RSCs to sensors applied to the patient, readings are displayed on the Set-up screen. However, trends are not tracked and physiological alarms are disabled. Do not attempt to monitor the patient from the Set-up screen.

Set Up for Patient Monitoring

tion. If the sensor was previously used on the monitoring system, the last baseline obtained on the sensor is also displayed.

light on the preamplifier and RSC. Connect the next sensor to the corresponding RSC.

tion and noting the blue flashing light on the RSC cable. Make sure that the onscreen location matches the sensor location on the patient. If the location does not match, you can reposition the on-screen sensors rather than disconnecting the RSCs. See Repositioning On-Screen Sensors, page 4-17.

6. Check the location of all cables connected to the monitoring system. Make sure that the

patient is not lying on any cables or connectors. To prevent entanglement and prolonged contact with patient skin, you can secure the RSCs with the strain-relief clips attached to the cables. Do not place the RSCs, preamplifiers, or cables connecting the preamplifiers to the monitor in contact with the patient.

7. Optionally, enter a patient ID. See Assigning or Modifying the Patient ID, page 4-19.

8. Begin monitoring by starting a new case or continuing an existing case:

• For a new case, press NEW DATA SET.

• To continue a case, press APPEND OLD DATA.

The monitoring screen appears.

Operator’s Manual 4-13

Operation

Figure4-2.Monitoring Screen - New Case - No Baselines Set

 Note:

If necessary, you can return to the Set-up screen while monitoring by pressing the Patient button:

9. Set baselines. See Baselines, page 4-24.

10. Set or change alarm limits, as desired. See Setting Alarm Limits, page 4-38.

11. Optionally, change the trend view. You can view all sensor readings on one graph or

two, use trend line averaging, and change the time scale. See Trend View Management, page 4-27.

12. Optionally, change the on-screen sensor labels. See Changing the On-Screen Sensor

Labels, page 4-21.

13. Optionally, check the list of available event markers and change it if necessary. See

Changing the Event List, page 4-47

14. Optionally, change the Area Under the Curve (AUC) threshold. See Changing the AUC

Threshold, page 4-50.

15. Optionally, adjust the screen brightness. See Changing the Screen Brightness, page 4-23.

16. Optionally, adjust the alarm volume. See Changing the Alarm Volume, page 4-40.

4-14 Operator’s Manual

17. As you monitor the patient, you may need to perform the following tasks:

• Respond to alarms - See Alarm Indicators, page 4-35, Alarm Messages, page 8-2,

• Mark clinically significant events - See Event Marks, page 4-44.

 Note:

In the event of defibrillation, the monitoring system will recover operation without intervention within 30 seconds after the defibrillation voltage is removed.

18. When the monitoring session is complete, follow the steps in Finish Monitoring, page 4-

51.

Set Up for Patient Monitoring

Silencing or Pausing Alarms, page 4-41, and Dismissing an Alarm, page 4-43.

Operator’s Manual 4-15

Operation

Optional Set-Up Tasks

4.8

• Changing the Sensor Placement Sequence

• Repositioning On-Screen Sensors

• Assigning or Modifying the Patient ID

• Changing the On-Screen Sensor Labels

• Changing the Screen Brightness

4.8.1 Changing the Sensor Placement Sequence

By default, the monitoring system assumes that you will use two cerebral sensors and two somatic sensors per case. You are prompted to connect the sensors in the following order:

Figure4-3.Default Sensor Placement Sequence

If you monitor a different combination of sites, you can change the prompts to one of the following sequences:

4-16 Operator’s Manual

Figure4-4.Optional Sensor Placement Sequences

To change the sensor placement sequence:

1. Press MENU.

Optional Set-Up Tasks

2. Press SETTINGS.

3. Press GENERAL.

4. Under SENSOR PLACEMENT SEQUENCE, press the desired sequence.

5. Press CLOSE.

4.8.2 Repositioning On-Screen Sensors

If the on-screen sensor representation does not correspond to sensor placement on the patient, you can reposition the on-screen sensors before or during monitoring.

To reposition the on-screen sensors before monitoring:

1. At the Set-up screen, briefly press an on-screen sensor icon to determine the corre-

sponding sensor’s location on the patient. The on-screen sensor icon is highlighted. The blue LEDs on the RSC and preamplifier flash to indicate the corresponding sensor.

Operator’s Manual 4-17

Operation

Figure4-5.Highlighting an On-Screen Sensor

2. Drag the on-screen sensor to a new position and release.

3. Confirm the new position by touching each highlighted on-screen sensor.

To reposition the on-screen sensors while monitoring:

1. At the monitoring screen, briefly press a sensor icon next to the CURRENT values to

determine the corresponding sensor’s location on the patient. The blue LEDs on the RSC and preamplifier flash to indicate the corresponding sensor.

Figure4-6.Sensor Icons Next to CURRENT Values (Press to Locate Sensor on Patient)

2. Press the Patient button. The patient icon appears.

4-18 Operator’s Manual

Figure4-7.Patient Icon

Optional Set-Up Tasks

3. Press Sensor Set-up.

4. At the Set-up screen, drag the on-screen sensor to a new position and release.

5. Confirm the new position by touching each highlighted on-screen sensor.

6. Press APPEND OLD DATA to resume monitoring. Note that there will be a brief gap in

the data on the trend graph.

4.8.3 Assigning or Modifying the Patient ID

By default, cases are identified by date and start/end time, but do not have patient IDs assigned. As an option, you can assign an alphanumeric patient ID to a case before or during monitoring. You can also modify a patient ID at any time while monitoring.

 Note:

Follow institutional protocols for assigning patient IDs. Avoid using patient-sensitive information in IDs.

To assign a patient ID before monitoring:

1. Set up the monitoring system as described in Set Up for Patient Monitoring, but do not

begin monitoring.

2. Press PATIENT ID. A keyboard appears.

Operator’s Manual 4-19

Operation

Figure4-8.Entering a Patient ID Before Monitoring

3. Type the patient ID.

4. Press CLOSE to dismiss the keyboard.

5. Begin the case by pressing NEW DATA SET.

To assign or modify a patient ID while monitoring:

1. After monitoring begins, press the Patient button. The patient icon appears.

Figure4-9.Patient Icon

2. Press the patient icon. A keyboard appears.

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Figure4-10.Entering a Patient ID During Monitoring

Optional Set-Up Tasks

3. Type the patient ID, or modify the existing ID.

4. Press CLOSE to dismiss the keyboard.

5. Press the Patient button to dismiss the patient icon.

4.8.4 Changing the On-Screen Sensor Labels

By default, sensors are labeled as follows on screen:

Left cerebral sensor

Right cerebral sensor

Right somatic sensor

Left somatic sensor

You can change the sensor labels to any alphabetic value (A - Z) or S1 - S4.

Operator’s Manual 4-21

Operation

 Note:

You can verify the location of a sensor by briefly pressing the sensor label next to the CURRENT value on the monitoring screen. The blue LEDs on the RSC light to indicate the corresponding sensor.

To change a sensor label:

1. After monitoring begins, press and hold the sensor label you want to change. A sensor

label menu appears.

Figure4-11.Sensor Label Menu

2. Scroll through the choices by pressing anywhere within the list and dragging up or

down. When you see the choice you want, press it to highlight it. Note that duplicate labels are not permitted.

3. Press CLOSE.

4. Verify that the sensor label has changed.

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4.8.5

Changing the Screen Brightness

By default, the screen brightness is set to 7 with a range of 1 to 10.

To change the screen brightness:

1. Press MENU.

2. Press SETTINGS.

3. Press GENERAL.

Figure4-12.SETTINGS - GENERAL - SCREEN BRIGHTNESS

Optional Set-Up Tasks

4. Press an arrow key to increase or decrease the screen brightness.

5. Press CLOSE.

Operator’s Manual 4-23

Operation

Baselines

4.9

The monitoring system requires an rSO2 baseline for each tissue region being monitored so that changes from the baseline can be reported. Changes in rSO2 values of >20% from baseline are considered clinically significant and cause for concern and

possible interventions.

When measured rSO system issues an alarm. You can use the monitoring system’s default alarm limits or

set custom limits, as described in Setting Alarm Limits, page 4-38.

It is recommended that you obtain baselines while the patient is stable and awake (for example, prior to surgical induction). You can set baselines for all sensors at once or for individual sensors. If necessary, you can retake baselines at any time during monitoring.

Automatic Baselines: If you do not actively set baselines, the monitoring system automatically sets them approximately five minutes after monitoring begins. You can use these automatic baselines, or retake the baselines. Be aware that sudden large changes in a patient’s saturation values during the initiation of monitoring can result in unrepresentative automatically calculated baseline values. If you use automatic baselines, be sure to check the values to make sure they are appropriate. Manually retake the baselines, if necessary.

 Note:

If you reposition or replace a sensor during monitoring, be sure to retake the baseline for that sensor to ensure a valid representation of rSO

To set or retake baselines:

1. Set up the monitoring system and begin monitoring as described in Set Up for Patient

values are below or above specific limits, the monitoring

at that location.

Monitoring, page 4-11. While baselines have not yet been set, the monitoring system

displays rotating arrows for the CHANGE values next to the CURRENT rSO

readings.

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Figure4-13.Monitoring Screen - New Data Set - No Baselines Set

Baselines

2. Press MENU.

3. Press SET BASELINES. The SET BASELINES screen either indicates that no baselines have

been set (no value next to “BL” as in Figure 4-14), or, if automatic baselines have taken effect, indicates the values and times they were taken (Figure 4-15).

Figure4-14.SET BASELINES - No Baselines Previously Set

Operator’s Manual 4-25

Operation

Figure4-15.SET BASELINES - Baselines Previously Set

4. Set baselines for an individual sensor or all sensors at once:

• Individual sensor - Press the on-screen circle representing the sensor. The baseline

is set to the current rSO

reading at that sensor site. The new baseline value is dis-

played with the date and time it was taken.

• All sensors - Press RETAKE ALL BASELINES. The baselines are set to the current rSO

readings at all sensor sites. The new baseline values are displayed with the date and time they were taken.

5. Press CLOSE.

The baseline values are indicated to the left of the trend graph, color-coded to the corresponding sensor label. An event marker in the trend graph indicates the point at which the baselines were taken.

The CHANGE values reflect the difference between the baselines and the CURRENT readings.

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Figure4-16.Monitoring Screen with Baselines Set

Trend View Management

 Note:

If you disconnect and re-connect the same sensor while monitoring, the baseline for that sensor is maintained. If you replace a sensor with a new sensor while monitoring, the baseline calculated with the previous sensor is applied to the new sensor. If the monitoring system is powered off and back on while monitoring, baselines are maintained for all sensors connected to the system.

4.10 Trend View Management

• About the Trend View

• Changing the Trend View - Two Graphs or One Graph

• Turning Trend Line Averaging On/Off

• Zooming the Trend View

• Reviewing Data that has Scrolled Off the Trend View

• Viewing Previous rSO2 Values on the Trend Graph

Operator’s Manual 4-27

Operation

4.10.1

About the Trend View

“Trend view” refers to the data graph on the monitoring screen.

The trend view shows the progression of rSO

values over the course of a case. It pro-

vides a visual reference for on-going rSO2 readings in relationship to baseline values and alarm limits, as well as a means to reference significant clinical events during the

case.

The trend view is stored in the monitoring system’s memory and can be reviewed at a later time. See Case Histories, page 4-52.

Figure4-17.Trend View

rSO2 scale (y-axis)

2 Current baselines (color-coded to sensor

labels).

3 Trend line (color-coded to sensor labels) 7 Event mark

4 Alarm limits (color-coded to sensor labels)

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5 Alarm limit line

6 Time scale (x-axis)

4.10.2

Changing the Trend View - Two Graphs or One Graph

By default, the monitoring system displays all trends on one graph (Figure 4-18, left). If desired, you can display trends on two graphs - one for cerebral sensors, one for somatic sensors (Figure 4-18, right).

Figure4-18.Trend View - One Graph (Left, Default) and Two Graphs (Right)

Trend View Management

To change the trend view (two graphs vs. one graph):

1. Press MENU.

2. Press SETTINGS.

3. Press TRENDS.

Operator’s Manual 4-29

Operation

Figure4-19.SETTINGS - TRENDS - TWO AXIS VIEW vs. ONE AXIS VIEW

4. Press TWO AXIS VIEW or ONE AXIS VIEW, as desired. Your choice is highlighted by a

white square.

5. Press CLOSE.

 Note:

The trend view setting remains in effect across power cycles.

4.10.3 Turning Trend Line Averaging On/Off

Trend line averaging provides a 60-minute rolling average of rSO2 values. Viewing a rolling average can be useful in situations where there is frequent and wide variabil-

ity in rSO the real-time rSO2 values in the graph. The trend line is the same color as the realtime values for each sensor. The numerical rSO2 values and percent change from baseline continue to be displayed in real-time.

values. The averaged data is displayed as a bold line superimposed over

4-30 Operator’s Manual

Figure4-20.Trend Line Averaging

Trend View Management

By default, trend line averaging is off.

To turn trend line averaging on/off:

1. Press MENU.

2. Press SETTINGS.

3. Press TRENDS.

Figure4-21.SETTINGS - TRENDS - TREND LINE AVERAGING

4. Press ON or OFF next to TREND LINE AVERAGING, as desired.

Operator’s Manual 4-31

Operation

5. Press CLOSE.

 Note:

The trend line averaging setting remains in effect across power cycles.

4.10.4 Zooming the Trend View

By default, the trend view shows 1 hour of data at a time. You can zoom the trend view to see different time intervals. Available intervals are 1, 2, 4, 8, 12, and 24 hours.

Note that only the horizontal axis (time) zooms, not the vertical axis (rSO

To zoom the trend view:

1. To zoom out and see a longer time range, place two fingers within the trend graph, 1-

2 inches apart horizontally, and slide together.

2. To zoom in and see a shorter time range, place two fingers within the trend graph, side-

by-side horizontally, and slide apart.

 Note:

The zoom setting remains in effect across power cycles.

4.10.5 Reviewing Data that has Scrolled Off the Trend View

During extended monitoring, trend data scrolls off the trend view to the left. You can review this trend data while monitoring by swiping the trend view to the right.

Current rSO trends are not displayed until you swipe the trend view back to the left. As an indi-

cation that current trends are not shown, “REVIEW MODE” appears on the trend view.

values are still displayed while you review older trends, but current

values).

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Figure4-22.Trend View Review Mode

Trend View Management

To review data that has scrolled off the trend view:

1. Briefly touch within the trend graph and swipe to the right. The data shifts back in time

as indicated by the time scale. The message “REVIEW MODE” appears.

2. Repeat swipes until the data you want to view appears. Note that the amount of shift

corresponds to the length of the swipe.

3. To return to current trend data, swipe to the left until the message “REVIEW MODE” no

longer appears.

4.10.6 Viewing Previous rSO

Values on the Trend Graph

While monitoring a patient, you can view rSO2 values that were recorded earlier in the case. Values appear in a pop-up corresponding to the point of interest (Figure 4-

23).

Operator’s Manual 4-33

Operation

Figure4-23.Trend Graph Pop-Up

To view previous rSO2 values on the trend graph:

1. Press and hold the point of interest on the trend graph. The values at that point appear

in a pop-up that indicates the time they were recorded.

Figure4-24.Monitoring Screen - Trend Graph Pop-Up

2. Slide your finger in either direction on the graph to see values at different times.

3. Release when finished viewing values.

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Alarm Management

4.11

• Alarm Indicators

• Setting Alarm Limits

• Changing the Alarm Volume

• Silencing or Pausing Alarms

• Dismissing an Alarm

 Note:

Refer to Table 8-1 on page 8-2 for a complete list of alarm messages, priorities, and resolutions.

Alarm Management

4.11.1 Alarm Indicators

The monitoring system uses audio and visual indicators to identify alarms.

The message area at the top of the monitoring screen indicates active alarms (Figure 4-25). If multiple alarms occur, the message area shows the color of the highest priority alarm and indicates the total number of alarms currently active. By pressing the arrow in the message area, you can expand the list and view all active alarms.

When an rSO

value crosses an alarm threshold, the background of the affected rSO2

reading flashes yellow.

The Alarm Audio button indicates alarm audio status. When alarms are silenced or paused, the Alarm Audio button also indicates alarm status (Table 4-5 on page 4-36).

Operator’s Manual 4-35

Operation

Figure4-25.Visual Alarm Indicators

1 Alarm Audio button 3 rSO2 reading in alarm state

2 Message area

Table4-5.Alarm Audio Button States

Alarm Audio

button

Alarm audio

on, silenced, or paused

On Alarm of any status or no alarms

Silenced No alarms

Alarm status

Low- or medium-priority alarm

4-36 Operator’s Manual

Table4-5.Alarm Audio Button States (Continued)

Alarm Management

Alarm Audio

button

Alarm audio

on, silenced, or paused

Alarm status

Paused (2 minutes) No alarms

Low- or medium-priority alarm

Table 4-6 summarizes the monitoring system’s alarm indicators.

Table4-6.Audible and Visual Alarm Indicators

Priority Audible

tone

Medium 3 pulse

burst

Visual indication

Message area: Flashing yellow bar with text message

Battery icon: For battery alarm, flashing yellow; otherwise, no change

readings area: Yellow flashing background on

rSO

affected reading for sensor alarms (dashes appear if readings are lost)

Alarm Audio button: Yellow if alarms silenced or paused

Example messages

BATTERY LOW LOW RSO2

Low 2 pulse

burst

Message area: Yellow bar with text message (not flashing)

TREND DATA LOST

Battery icon: No change

readings area: No change

rSO

Alarm Audio button: Yellow if alarms silenced or paused

1. By default, alarm audio is on, but may be silenced or paused by the user. See Silencing or Pausing Alarms, page 4-41. See Table 11-

2 on page 11-5 for alarm tone specifications.

2. See Table 11-4 on page 11-5 for alarm visual specifications.

3. See Table 8-1 on page 8-2 for a complete list of alarm messages.

Operator’s Manual 4-37

Operation

4.11.2

Setting Alarm Limits

 WARNING:

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

The monitoring system provides default alarm limit settings, as listed in Table4-7.

You can change the alarm limits before or after setting baselines, or you can use the existing alarm limits. Alarm limits are retained across power cycles, so check the current settings to determine if they are appropriate for the patient.

Alarm limits item Available settings Default

Table4-7.Alarm Limits Settings

UPPER LIMITS OFF - No alarm sounds for high rSO2 values

Upper limit range (when ON)

LOWER LIMITS MANUAL - Specify a low rSO

Lower limit range when set to MANUAL

Lower limit range when set to AUTO

 Note:

Upper and lower alarm limits for each sensor are not allowed to cross.

To set alarm limits:

1. Press MENU.

2. Press ALARM LIMITS. The SET ALARM LIMITS screen shows the most recent limits set (or

ON - Specify a high rSO

20 - 95 90

AUTO - Specify a percentage below baseline that will generate an alarm

15 - 90 40

-30% to -5% -20%

value that will generate an alarm

the defaults if limits have not previously been set).

OFF

MANUAL

4-38 Operator’s Manual

Figure4-26.SET ALARM LIMITS - Default Settings

Alarm Management

 Note:

Four sensors are shown even if fewer are in use.

3. To set upper alarm limits:

a. Press ON for UPPER LIMITS. A second scale appears for each sensor.

Figure4-27.SET ALARM LIMITS - Upper Limits On

b. Next to a sensor, press and hold the slider for the UPPER limit, drag it to the desired

value, and release. You can set different values for each sensor.

Operator’s Manual 4-39

Operation

4. To set lower alarm limits:

a. Press MANUAL or AUTO for LOWER LIMITS, as desired.

b. Next to a sensor, press and hold the slider for the LOWER limit, drag it to the desired

value, and release. You can set different values for each sensor.

5. Press CLOSE. The new alarm limits take effect immediately.

 Note:

Alarm limit settings remain in effect across power cycles.

4.11.3 Changing the Alarm Volume

 WARNING:

Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

When alarm audio is on, the default alarm volume is set to 5 with a range of 1 to 10. See Table 11-2 on page 11-5 for alarm tone specifications.

To change the alarm volume:

1. Press MENU.

2. Press SETTINGS.

3. Press ALARMS.

4-40 Operator’s Manual

Figure4-28.SETTINGS - ALARMS - ALARM VOLUME

Alarm Management

4. Press an arrow key to increase or decrease the alarm volume.

5. Press CLOSE.

 Note:

The alarm volume setting remains in effect across power cycles.

4.11.4 Silencing or Pausing Alarms

 WARNING:

Do not silence, pause, or decrease the volume of audible alarms if patient safety could be compromised.

Depending on your institutional default, alarm audio may be on or off when you start a case. When alarm audio is on, you can silence or pause the audio.

A white Alarm Audio button indicates alarm audio is on. You can silence or pause alarms by pressing the button. The button changes to indicate whether alarms are silenced or paused (see Table 4-5 on page 4-36). Whether an alarm is silenced or paused depends on institutional default settings (see Alarm Silence Duration, page 4-

42).

If an alarm condition occurs when alarm audio is silenced or paused, the Alarm Audio button changes color to match the current highest-priority alarm condition

Operator’s Manual 4-41

Operation

(see Table 4-5 on page 4-36).

If alarms are silenced or paused, you can turn alarm audio back on by pressing the Alarm Audio button. The button changes to the following:

 Note:

When alarms are silenced or paused, the following alarms are not silenced:

- BATTERY CRITICALLY LOW (while monitoring system is operating on battery power)

- SYSTEM FAILURE (under certain circumstances)

 Note:

After a power cycle, the last setting used (alarm audio on or silenced) is retained.

Alarm Silence Duration

Pressing the Alarm Audio button either silences alarms or pauses them temporarily, depending on institutional defaults. The factory default is permanent silence of alarms.

The pause option, which must be set by an authorized technician, is 2 minutes. If the pause option is implemented, a countdown timer appears below the Alarm Audio button when the button is pressed to pause an alarm. After 2 minutes, alarm audio resumes.

Alarm Reminder Signal

By default, there is no reminder signal to indicate that alarms are silenced or paused. Alarm silence reminders may be turned on by an authorized technician. See Alarm

Audio and Visual Characteristics, page 11-4 for alarm reminder signal specifications.

4-42 Operator’s Manual

4.11.5

Dismissing an Alarm

Some alarms, such as BATTERY LOW and SENSOR NOT CONNECTED, can be dismissed without resolving the situation. Others, such as LOW RSO2 and CHECK SENSOR, clear only when the condition is resolved. Table 8-1 on page 8-2 indicates which alarms are dismissible and which are not.

To dismiss an alarm:

1. Note whether the DISMISS button is available in the alarm message area and whether

there are multiple alarms occurring. When there are multiple alarms, the DISMISS button applies only to dismissible alarms.

Figure4-29.Dismissible Alarm

Alarm Management

2. If there are multiple alarms, press the down arrow to view all current alarms and deter-

mine which are appropriate to be dismissed.

3. Press DISMISS next to the appropriate alarm. Dismissible alarms can only be dismissed

individually.

Operator’s Manual 4-43

Operation

Event Marks

4.12

• About Event Marks

• Marking Events

• Viewing an Event Mark Label

• Renaming an Event

• Changing the Event List

4.12.1 About Event Marks

Use event marks to indicate significant occurrences during monitoring. Choose from a list of events that is customizable for specific cases. Event marks are displayed on the trend graph as vertical lines with flags and stored in memory for case history review. Note that when baselines are set (either automatically or manually), an event mark is automatically added to the trend graph.

Figure4-30.Events Marked in Trend View

4-44 Operator’s Manual

4.12.2

Marking Events

To mark an event:

1. While monitoring, press MARK EVENT. The ADD EVENT menu lists the available events.

Figure4-31.ADD EVENT Menu

Event Marks

2. Scroll through the list by pressing anywhere within the list and dragging up or down.

When you see the event you want, press it to highlight it. (If you don’t see the event you want, see Changing the Event List, page 4-47.)

3. Press OK. The event mark appears on the trend graph.

4.12.3 Viewing an Event Mark Label

Event mark labels indicate the event name and the time the event was recorded. You can view event mark labels while monitoring or reviewing a case history.

To view an event mark label:

1. At the trend graph, press the flag below an event mark line. The event name and time

appear for approximately 5 seconds.

Operator’s Manual 4-45

Operation

Figure4-32.Event Mark Label

4.12.4 Renaming an Event

If an event is mis-named, you can change it at any time while monitoring or reviewing a case history.

To rename an event:

1. At the trend graph, press the flag below an event mark line.

2. When the event mark label appears, release the flag and press the label or the flag again.

The EDIT EVENT menu appears.

4-46 Operator’s Manual

Figure4-33.EDIT EVENT Menu

Event Marks

3. Scroll through the list by pressing anywhere within the list and dragging up or down.

When you see the event you want, press it to highlight it. (If you don’t see the event you want, see Changing the Event List, page 4-47.)

4. Press OK.

5. Press the flag below the event mark line to verify the change.

4.12.5 Changing the Event List

A default list of common events is provided. You can change the list before or during a case.

 Note:

Be aware that changes to the list are retained across power cycles, so the list you see may reflect a previous case. Make sure that the list of events is appropriate for your patient.

To change the event list:

1. Press MENU.

2. Press SETTINGS.

3. Press EVENTS. One of several screens of available events appears. An X next to an event

indicates that it currently appears in the ADD EVENT and EDIT EVENT menus.

Operator’s Manual 4-47

Operation

Figure4-34.SETTINGS - EVENTS (Screen 1)

4. Press NEXT or BACK to view all of the available events in alphabetical order.

5. To select or de-select an individual event, press the checkbox next to the event or the

event itself. If necessary, you can restore the list to its default values by pressing RESTORE.

6. Press CLOSE.

4-48 Operator’s Manual

Medtronic PM7100_Operaters_Manual_en_PT00097962B00 INVOS Patient Monitor Operator’s Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of Contents

List of Tables

List of Figures

1.1 Overview

1.2 Intended Audience

Safety Information

1.3.1 Safety Symbols

1.3.2 Explosion, Shock, and Toxicity Hazards

1.3.3 Patient Monitoring and Safety

1.3.4 Operation

1.3.5 Sensors, Cables, and Other Accessories

1.3.6 Electromagnetic Interference

1.3.7 Cleaning

1.4 Obtaining Technical Assistance

1.4.1 Technical Services

1.4.2 Related Documents

Warranty Information

2.1 Overview

2.2 Product Description

2.3 Indications for Use

Product Views

2.4.1 Full System

System Component Overview

Monitor Components

Monitor - Front

Monitor - Left Side

Monitor - Right Side

Monitor - Back

Docking Station

Monitoring Screen

Product and Carton Label Symbols

3.1 Overview

3.2 Safety Reminders

3.3 Unpacking and Inspection

Power Options

3.4.1 AC Power

3.4.2 Battery Power

Battery Status Indicators

Battery Life

3.5 Setup

3.5.1 Install the Battery

3.5.2 Insert the Monitor into the Docking Station

Connect the Preamplifier(s)

Connect the Reusable Sensor Cables (RSCs)

Apply Power

Set Institutional Defaults

Power Off the Monitoring System

3.5.8 Position the Monitoring System in the Clinical Setting

4.1 Overview

Safety Reminders

Quick Start

Operational Defaults

Menu Structure

4.6 Monitoring System Memory

Set Up for Patient Monitoring

Optional Set-Up Tasks

4.8.1 Changing the Sensor Placement Sequence

4.8.2 Repositioning On-Screen Sensors

4.8.3 Assigning or Modifying the Patient ID

4.8.4 Changing the On-Screen Sensor Labels

Changing the Screen Brightness

Baselines

4.10 Trend View Management

About the Trend View

Changing the Trend View - Two Graphs or One Graph

4.10.3 Turning Trend Line Averaging On/Off

4.10.4 Zooming the Trend View

4.10.5 Reviewing Data that has Scrolled Off the Trend View

Alarm Management

4.11.1 Alarm Indicators

Setting Alarm Limits

4.11.3 Changing the Alarm Volume

4.11.4 Silencing or Pausing Alarms

Alarm Silence Duration

Alarm Reminder Signal

Dismissing an Alarm