PM7100_Operaters_Manual_en_PT00097962B00

Operator’s Manual
TM
INVOS
Patient Monitor
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™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Table of Contents
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

4.3 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

5.3 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

6.3 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

7.3 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 rSO2 Sensor Operating Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
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 (R2)
for rSO2 and fSO2, 20 Subjects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Table A-2. Trend Bias, Error (SD), and Correlation (R2) 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 rSO2 and fSO2, 20 Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Figure A-2. Trend rSO2 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 opera-
tion 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
1.3 Safety Information

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

Safety Information
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
 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:
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 multi-
parameter system for generating alarms.
 WARNING:
Choking hazard — The reusable sensor cables (RSCs) include a strain-relief clip that,
if detached, may pose a choking hazard.
 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.
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:
 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

Safety Information
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.
 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:

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

Obtaining Technical Assistance
 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
 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

Introduction
on the back of the monitor and the preamplifiers. The software version for the mon-
itoring 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 rSO2 Sensor Instructions for Use — Provides important information
about sensor selection and use.
• INVOS™ Preamplifier Instructions for Use — Provides instructions for connecting

the monitoring system’s preamplifiers.
• INVOS™ Patient Monitor Service Manual — Provides information to authorized tech-

nicians for use when servicing the monitoring system.

Warranty Information
1.5 Warranty Information

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.

Introduction

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 (rSO2) 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™ rSO2 sensors
• Additional accessories as described in Accessories, page 9-1
2-1
Product Overview
Monitoring system features include:

• User configurable rSO2 baselines (page 4-24), alarm limits (page 4-38), and AUC thresh-
olds (page 4-49)
• Physiological and technical alarm reporting (page 8-2)
• User configurable data display (rSO2, 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.

Product Views
2.4 Product Views
2.4.1 Full System
System Component Overview
Figure 2-1. INVOS™ Patient Monitor Components
1 Sensors 4 Monitor
2 Preamplifier 5 Reusable sensor cable (RSC)
3 Docking station

Product Overview
2.4.2 Monitor Components
Monitor - Front
Figure 2-2. Monitor - Front
1 VESA™*-compliant stand accessory 4 Monitor indicators (power/battery, hard disk activ-

ity, wireless)
2 Power cord (connected to 5 Monitor

bottom of docking station)
3 Docking station 6 Docking station power indicator (illuminates blue

when the docking station is receiving AC power)

Product Views
Monitor - Left Side
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

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)

Product Views
Monitor - Back
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

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

Product Views
Figure 2-7. Docking Station - Connector for Monitor
1 Docking station 2 Connector for monitor

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 Available in the message area when an alarm is dismissible. See Dismissing
(not shown) an Alarm, page 4-43.
2 Sensor icons Each sensor icon has a label indicating its location on the patient. See Chang-
ing the On-Screen Sensor Labels, page 4-21.
3 Date and time Current date in MM/DD/YYYY format (by default) and current time in 12-
hour HH:MM:SS format (by default). The date and time format can be
changed by an authorized technician.

Product Views
4 Battery status Indicates the remaining battery capacity:

indicator • Charged battery — The level in the icon decreases as battery power
is used.
• Low battery — A medium-priority alarm occurs when the monitor-

ing 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 auto-
matically shuts down.
5 Battery charging Indicates that the monitoring system is connected to AC power and the
indicator battery is charging.
AC power When the battery is fully charged and the monitoring system remains con-
indicator nected 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 rSO2 reading and the established
baseline for each sensor, color-coded to the corresponding sensor icon.
8 Sensor/readings in If a sensor alarm or loss of readings occurs, the corresponding sensor is high-
alarm state lighted 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 dis-
played as vertical lines with flags. See Event Marks, page 4-44.
11 Baseline values The current rSO2 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 corre-
sponding sensor icon. See Baselines, page 4-24.

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 Press to add an event mark to the trend graph to indicate a significant occur-
button rence 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 rSO2 values over the course of a
case. Data is color-coded to the corresponding sensor icon. rSO2 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.

Product and Carton Label Symbols
2.5 Product and Carton Label Symbols
Table 2-1. Label Symbol Descriptions
Symbol Description Symbol Description
Reference code (part number) Serial number
European Community (EC) authorized

Lot number
representative
Prescription only Protection against fluid ingress: Protect-

US federal law restricts this device to ed against vertically falling water drops
sale by or on the order of a physician when tilted to 15º
Manufacturer Date of manufacture
Fragile Keep dry
Must consult instructions for use Consult instructions for use
Atmospheric pressure limits (see Envi- Temperature limits (see Environmental

ronmental Conditions, page 11-4) Conditions, page 11-4)
Humidity limits (see Environmental Proper waste disposal for electrical and
Conditions, page 11-4) electronic equipment
MR unsafe - Do not use during magnet-

Defibrillation-proof type BF applied part
ic resonance imaging
CE – Conformité Européene authoriza-

CSA – Canadian Standards Association tion mark
certification mark 0123 – TÜV SÜD Product Service GmbH
(notified body)
Electromagnetic interference may

Not made with natural rubber latex 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 (exam-

Do not immerse
ple: 20)

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:
 WARNING:
on AC power.
 WARNING:
 Caution:
3-1
Installation
 Caution:
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 Tech-
nical 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 1
Preamplifiers 1 or 2
Reusable sensor cables (RSCs) 2 or 4
INVOS™ adult rSO2 sensors Box of 5, 10, or 20
AC power supply 1
Power cord 1
Operator’s manual (on USB flash drive)1 1
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.

Power Options
3.4 Power Options

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

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

Power Options
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)
AC not connected One of the following, depending on battery

charge level. See Table 3-3, page 3-6.
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.

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 N/A N/A

(33% - 100% remaining)
Low Medium priority BATTERY LOW

(<33% remaining)
Critically Low Medium priority BATTERY CRITICALLY LOW

(<5% remaining)
Malfunctioning Low priority - no BATTERY FAILURE

audible alarm

Setup
Battery Life
 Caution:
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 obtain-
ing replacement batteries. See Technical Services, page 1-7.
3.5 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.

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).

Setup
Figure 3-5. Battery Installed in Monitor
3.5.2 Insert the Monitor into the Docking Station
The docking station is intended to hold the monitor during typical use of the mon-
itoring 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.

Installation
Figure 3-6. Monitor Mounted in Docking Station

Setup
3.5.3 Connect the Preamplifier(s)
 Caution:
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).
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.

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.

Setup
3.5.5 Apply Power
 WARNING:
Before applying power, refer to Power Options, page 3-3 to understand the require-
ments 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.
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.

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).

Setup
Figure 3-11. Set-Up Screen - Preamplifier(s) Connected
 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.
Figure 3-12. Set-Up Screen - No Preamplifier(s) Connected
 Note:
Make sure that the battery is fully charged prior to clinical use. Table 3-2, page 3-5,
describes the charging status indicators.

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 monitor-
ing 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 YES, NO NO - Alarms will sound unless the user
presses the Alarm Audio button
Alarm audio off/pause INDEFINITE, 2 MINS INDEFINITE - When silenced by the

duration user, alarms remain silent until the
user unsilences them
Alarm reminder signal ON, OFF OFF
Line frequency 50 Hz, 60 Hz 60 Hz
POST during sensor off ON, OFF OFF

For system diagnostics only. Do not
set to ON when used in a clinical set-
ting.
Date (Select from calendar) Coordinated Universal Time (UTC)
Date format DD MM YYYY, YYYY MM DD, MM DD MM DD YYYY

YYYY
Time (Select hh:mm) N/A
Time format 24 hr, 12 hr 12 hr
Language DANISH, DUTCH, ENGLISH, FRENCH, ENGLISH

GERMAN, GREEK, HUNGARIAN, ITAL-
IAN, NORWEGIAN, POLISH, PORTU-
GUESE, ROMANIAN, RUSSIAN,
SLOVAK, SPANISH, SWEDISH
Serial port OFF, PC LINK 1, PC LINK 2, CLINICAL OFF

TEST SETUP, VUE LINK

Setup
3.5.7 Power Off the Monitoring System
To power off the monitoring system:

1. 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 con-
nected.
3.5.8 Position the Monitoring System in the Clinical Setting
 WARNING:
Users may choose from a variety of mounting configurations, including the provid-
ed monitor stand or other VESA™*-compatible mounting options capable of sup-
porting 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

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 stran-
gulation.
• 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
rSO2 values and alarms. See Physical Characteristics, page 11-2 for visibility specifications.

4 Operation
4.1 Overview
This chapter explains how to use the INVOS™ patient monitor (the “monitoring sys-
tem”) to view and collect patient regional oxygen saturation (rSO2) data.
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.
• Quick Start, page 4-5
• Operational Defaults, page 4-7
• Menu Structure, page 4-9
• Monitoring System Memory, page 4-9
• 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
 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:
 WARNING:
Explosion hazard — Do not use the monitoring system in the presence of flammable
anesthetics.
 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:
 WARNING:
 WARNING:
 WARNING:

Safety Reminders
 WARNING:
 WARNING:
Failure to cover the sensor site with opaque material when operating under high
ambient light conditions may result in poor performance.
 WARNING:
critical devices.
 WARNING:
 WARNING:
 WARNING:
 WARNING:
 WARNING:
operate correctly.

Operation
 WARNING:
 WARNING:
 Caution:
 Caution:
 Caution:
 Caution:
readings at all.
Refer to Safety Information, page 1-2 for additional warnings and cautions regarding
use of the monitoring system.

Quick Start
4.3 Quick Start

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
1 Make sure all components of the monitoring system See Set Up for Patient Monitoring, page 4-
are present: 11
Monitor, docking station, power supply, power cord,
preamplifier(s), reusable sensor cables (RSCs), INVOS™
rSO2 sensors
2 Attach up to four INVOS™ rSO2 sensors to the See the Instructions for Use provided with
patient the sensors
3 Power on the monitoring system See Set Up for Patient Monitoring, page 4-
11
4 Optionally, change the sensor placement sequence See Changing the Sensor Placement
Sequence, page 4-16
5 Connect the sensors to the RSCs, following the on- See Set Up for Patient Monitoring, page 4-
screen prompts, and verify the sensor locations 11
6 Secure all cables to avoid patient skin injury or See Set Up for Patient Monitoring, page 4-
entanglement 11
7 Optionally, enter a patient ID See Assigning or Modifying the Patient ID,

page 4-19
8 Begin monitoring: See Set Up for Patient Monitoring, page 4-

- For a new case, press NEW DATA SET 11
- To continue a case, press APPEND OLD DATA
9 Set baselines See Baselines, page 4-24

Press MENU, SET BASELINES
10 Set or change alarm limits, as desired See Setting Alarm Limits, page 4-38
Press MENU, ALARM LIMITS
11 Optionally, change the trend view: See Trend View Management, page 4-27
- Number of graphs
- Trend-line averaging
- Time scale

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 See Changing the Event List, page 4-47
markers
14 Optionally, change Area Under the Curve (AUC) See Changing the AUC Threshold, page 4-
thresholds 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
17 Respond to alarms, as necessary: See:

- Alarm indicators - Alarm Indicators, page 4-35
- Alarm message lookup - Alarm Messages, page 8-2
- Silence or pause alarms - Silencing or Pausing Alarms, page 4-41
- Dismiss alarms - Dismissing an Alarm, page 4-43
18 Mark events, as desired See Event Marks, page 4-44
19 Finish monitoring See Finish Monitoring, page 4-51

Operational Defaults
4.4 Operational Defaults

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 indi-
cated.
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

Upper rSO2 limit 20 - 95 If ON, default is 90

Lower rSO2 limit MANUAL: 15 - 90 MANUAL: 40

AUTO: 5 - 30 AUTO: 20
Silence alarms at YES, NO NO - Alarm audio is on by default, but alarm

startup 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.
Alarm audio off/ INDEFINITE, 2 MINS INDEFINITE - When silenced, alarms remain silent
pause duration until the user unsilences them. See Alarm Silence
Duration, page 4-42.
technician.
Alarm reminder signal ON, OFF OFF - No reminder when alarms are silenced
technician.
Line frequency 50 Hz, 60 Hz 60 Hz

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

Operation
Table 4-2. Operational Defaults (Continued)
Item Available settings Default
Time format 24 hr, 12 hr 12 hr

technician.
Date format DD MM YYYY, YYYY MM DD, MM DD YYYY

MM DD YYY This setting may be changed by an authorized
technician.
Language Danish, Dutch, English, English

French, German, Greek, Hun- This setting may be changed by an authorized
garian, Italian, Norwegian, technician.
Polish, Portuguese, Romanian,
Russian, Slovak, Spanish,
Swedish
Trend line averaging ON, OFF OFF

See Turning Trend Line Averaging On/Off, page 4-
30
Trend axis view TWO AXIS VIEW, ONE AXIS ONE AXIS VIEW
VIEW See Changing the Trend View - Two Graphs or One
Graph, page 4-29
Trend time scale 1, 2, 4, 8, 12, 24 hours 1 hour

(x-axis) See Zooming the Trend View, page 4-32
Sensor placement 4, 3, or 2 sensors 4 sensors

sequence See Changing the Sensor Placement Sequence,
page 4-16
AUC threshold type FIXED FIXED

% BELOW BASELINE See Changing the AUC Threshold, page 4-50
AUC threshold FIXED: 30 - 60 FIXED: 50

% BELOW BASELINE: 0 - 30% % BELOW BASELINE: 25%
See Changing the AUC Threshold, page 4-50
Serial port OFF, PC LINK 1, PC LINK 2, OFF

CLINICAL TEST SETUP, VUE This setting may be changed by an authorized
LINK technician.

Menu Structure
4.5 Menu Structure
Table 4-3. Menu Structure
MENU ALARM LIMITS UPPER LIMITS
LOWER LIMITS
SETTINGS GENERAL SCREEN BRIGHTNESS
SENSOR PLACEMENT SEQUENCE
ALARMS ALARM VOLUME
TRENDS TREND LINE AVERAGING
TWO AXIS VIEW/ONE AXIS VIEW
EVENTS
CASE HISTORIES1
SET BASELINES2
AREA UNDER CURVE2 RESET AUC
THRESHOLD
1. Available only when no sensors are connected to the monitoring system.
2. Available only when monitoring has begun.
4.6 Monitoring System Memory

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).

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 Navigate to the sensor Set-up screen (see Repositioning On-Screen
but notice that you have the sensor Sensors, page 4-17), drag and drop the sensors to the correct loca-
locations swapped. tions on the screen, confirm the new locations, then press APPEND
OLD DATA to resume monitoring.
Sensors need to be disconnected Disconnect and reconnect the affected sensors. The monitoring
from the monitoring system during a system automatically assigns the sensors back to the proper loca-
case (for example, to reroute the tions.
cables).
The monitoring system is powered off No action is necessary. The monitoring system automatically
and back on during a case. assigns sensors to the proper location and resumes monitoring.
A case has ended. Unplug and discard all sensors that were used during the case.
Dismiss the “Sensor Not Connected” alarm. The monitoring system
returns to the Set-up screen.

Set Up for Patient Monitoring
4.7 Set Up for Patient Monitoring

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 3-
12, for instructions.
• INVOS™ rSO2 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™
rSO2 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 instruc-
tions.
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 deter-
mine whether the battery needs charging (see Table 3-3, page 3-6).

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 on-
screen 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:
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 rSO2 reading at the corresponding sensor loca-

tion. If the sensor was previously used on the monitoring system, the last baseline
obtained on the sensor is also displayed.
e. Look for the next highlighted sensor location on screen and the next flashing blue
light on the preamplifier and RSC. Connect the next sensor to the corresponding
RSC.
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-
tion and noting the blue flashing light on the RSC cable. Make sure that the on-
screen 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.
 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.
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 pro-
longed 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.

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.

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

Operation
4.8 Optional Set-Up Tasks

• 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:

Optional Set-Up Tasks
Figure 4-4. Optional Sensor Placement Sequences
To change the sensor placement sequence:

1. Press MENU.
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.

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.

Figure 4-7. Patient Icon
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.

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.

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

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.

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

Operation
4.9 Baselines
The monitoring system requires an rSO2 baseline for each tissue region being mon-
itored 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 rSO2 values are below or above specific limits, the monitoring
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 auto-
matic baselines, be sure to check the values to make sure they are appropriate. Man-
ually 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 rSO2 at that location.
To set or retake baselines:
1. Set up the monitoring system and begin monitoring as described in Set Up for Patient
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 rSO2 readings.

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

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 rSO2 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 rSO2
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.

Trend View Management
Figure 4-16. Monitoring Screen with Baselines Set
 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

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 rSO2 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
1 rSO2 scale (y-axis) 5 Alarm limit line
2 Current baselines (color-coded to sensor 6 Time scale (x-axis)

labels).
3 Trend line (color-coded to sensor labels) 7 Event mark
4 Alarm limits (color-coded to sensor labels)

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

1. Press MENU.
2. Press SETTINGS.
3. Press TRENDS.

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 rSO2 values. The averaged data is displayed as a bold line superimposed over
the real-time rSO2 values in the graph. The trend line is the same color as the real-
time values for each sensor. The numerical rSO2 values and percent change from
baseline continue to be displayed in real-time.

Figure 4-20. Trend Line Averaging
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.

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 (rSO2 values).
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 rSO2 values are still displayed while you review older trends, but current
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.

Figure 4-22. Trend View Review Mode
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 rSO2 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).

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.

Alarm Management
4.11 Alarm Management

• 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.
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 rSO2 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).

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 Alarm audio Alarm status

button on, silenced, or paused
On Alarm of any status or no alarms
Silenced No alarms
Low- or medium-priority alarm

Alarm Management
Table 4-5. Alarm Audio Button States (Continued)
Alarm Audio Alarm audio Alarm status

button on, silenced, or paused
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 Visual indication2 Example messages3

tone1
Medium 3 pulse Message area: Flashing yellow bar with text BATTERY LOW
burst message LOW RSO2
Battery icon: For battery alarm, flashing yellow; oth-
erwise, no change
rSO2 readings area: Yellow flashing background on
affected reading for sensor alarms (dashes appear if
readings are lost)
Alarm Audio button: Yellow if alarms silenced or
paused
Low 2 pulse Message area: Yellow bar with text message (not TREND DATA LOST
burst flashing)
Battery icon: No change
rSO2 readings area: No change
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.

Operation
4.11.2 Setting Alarm Limits
 WARNING:
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.
Table 4-7. Alarm Limits Settings
Alarm limits item Available settings Default
UPPER LIMITS OFF - No alarm sounds for high rSO2 values OFF
ON - Specify a high rSO2 value that will generate an alarm
Upper limit range 20 - 95 90

(when ON)
LOWER LIMITS MANUAL - Specify a low rSO2 value that will generate an alarm MANUAL
AUTO - Specify a percentage below baseline that will generate
an alarm
Lower limit range 15 - 90 40

when set to MANUAL
Lower limit range -30% to -5% -20%

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
the defaults if limits have not previously been set).

Alarm Management
Figure 4-26. SET ALARM LIMITS - Default Settings
 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.

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:
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.

Alarm Management
Figure 4-28. SETTINGS - ALARMS - ALARM VOLUME
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:
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

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.

Alarm Management
4.11.5 Dismissing an Alarm
Some alarms, such as BATTERY LOW and SENSOR NOT CONNECTED, can be dis-
missed 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
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.

Operation
4.12 Event Marks

• 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

Event Marks
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
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.

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 review-
ing 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.

Event Marks
Figure 4-33. EDIT EVENT Menu
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.

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.

Area Under the Curve (AUC)
4.13 Area Under the Curve (AUC)

• About Area Under the Curve (AUC)
• Changing the AUC Threshold
• Resetting AUC Collection
4.13.1 About Area Under the Curve (AUC)

Figure 4-35. AUC SUMMARY Screen
1 Current AUC totals 4 RESET AUC (press to restart collection)
2 Current baselines 5 Current AUC threshold type (press to

change)
3 AUC start time 6 Current AUC threshold (press arrow keys

to change)
AUC (Area Under the Curve), also referred to as cumulative saturation below thresh-
old, quantifies the depth and duration of desaturation below a specific value.
AUC was originally a metric in The STS (Society of Thoracic Surgeons) Adult Cardiac
Surgery Database and Congenital Heart Surgery Database. High AUC calculated

Operation
from a threshold of 25% below baseline rSO2 has been found to correlate with
increased morbidity.
By default, the monitoring system uses a threshold of 50 for AUC calculations. If
desired, you can change the AUC threshold to any value between 30 and 60, or you
can specify a percentage below baseline from 0% to 30%.
The monitoring system automatically calculates AUC by multiplying the difference
between the threshold and the current rSO2 values times the duration that rSO2 is
below the threshold. Units are minute-%. Values are accumulated throughout the
case. The AUC threshold applies to all sensors being monitored.
 Note:
If you retake baselines at any point while monitoring, the monitoring system does not reset
AUC data collection to zero. If desired, you can reset AUC data collection as described in
Resetting AUC Collection, page 4-51.
4.13.2 Changing the AUC Threshold
By default, rSO2 values must fall below a fixed threshold of 50 to be included in AUC
totals. You can change this threshold any time after monitoring begins.
 Note:
Be aware that changes to the AUC threshold are retained across power cycles, so the current
setting may reflect a previous case. Check the setting to make sure that it is appropriate for
your patient.
To change the AUC threshold:
1. After monitoring begins, press MENU.
2. Press AREA UNDER CURVE.
3. At the AUC SUMMARY screen, the type of threshold currently in use is indicated (see
Figure 4-35 on page 4-49):
• FIXED, or
• % BELOW BASELINE
Press to toggle between the two choices.

Finish Monitoring
4. Adjust the value for the threshold by pressing the arrow buttons. The ranges are:
• FIXED: 30 - 60
• % BELOW BASELINE: 0% - 30%
5. Press CLOSE.
4.13.3 Resetting AUC Collection
You can reset AUC data collection to zero at any point while monitoring. AUC data
collection restarts at the time of reset.
To reset AUC Collection:
1. After monitoring begins, press MENU.
2. Press AREA UNDER CURVE.
3. At the AUC SUMMARY screen, press RESET AUC (see Figure 4-35 on page 4-49).
4. Press CLOSE.
4.14 Finish Monitoring

To finish monitoring a patient:
1. Power off the monitoring system by pressing the power button on top of the monitor
for approximately 3 seconds.
2. Disconnect the RSCs from the sensors, and unclip the RSC strain-relief clips, if used. You
can leave the RSCs connected to the preamplifier(s).
3. Carefully remove the sensors from the patient. Dispose of the sensors according to insti-
tution procedures for single-use devices.
4. Clean the monitoring system as required by your institution. See Cleaning the Monitor-
ing System, page 7-2.

Operation
4.15 Case Histories

• About Case Histories
• Viewing Case Histories
• Exporting Case Histories
4.15.1 About Case Histories
While not actively monitoring a patient, you can view case histories stored on the
monitoring system. You can also export case histories to a USB flash drive and review
or store them off-line.
The monitoring system automatically records trend data every 5 seconds and stores
up to 30 days (720 hours) of data in any combination of cases. When storage capac-
ity is reached, the monitoring system overwrites the oldest data to make room for
new data.
4.15.2 Viewing Case Histories
To view a case history:

1. Make sure that the monitoring system is powered on but that no sensors are connect-
ed.
2. Press MENU.
3. Press CASE HISTORIES. The CASE HISTORY list appears.

Case Histories
Figure 4-36. CASE HISTORY List
4. Locate a case using the following methods:
• Sort the list by pressing DATE or PATIENT ID. Press your choice again to reverse the
sort order.
• Scroll through the cases by pressing anywhere within the list and dragging up or
down.
5. Press FULL CASE next to the case you want to view. The trend data for the case is dis-
played.

Operation
Figure 4-37. Case History Example
6. View items in the case history as follows:
• Zoom the trend graph. See Zooming the Trend View, page 4-32.
• Press the trend graph at any location to see the readings at that point in the case.
The vertical line with the magnifier moves to that point. Slide your finger along the
graph to move the vertical line left or right to see additional values. If an alarm
occurred at any point, the alarm message is displayed and the sensor reading is
highlighted, if applicable.
• Scroll backward and forward in time by briefly touching within the trend graph and
swiping to the right or left. The shift is indicated by the time scale. Repeat swipes
until the data you want to view appears. Note that the amount of shift corresponds
to the length of the swipe.
• View an event mark label by pressing the flag below the vertical event line. See
Viewing an Event Mark Label, page 4-45.
• Change an event mark label, if necessary, as described in Renaming an Event, page

4-46.
• Add a new event mark by pressing the trend graph at the location of the event, then
pressing the Add Event button at the top of the screen. Select an event as described
in Marking Events, page 4-45.
• Export the case history, if desired. See Exporting Case Histories, page 4-55.
7. Press CLOSE to exit the case history view.

Case Histories
8. Press CLOSE to exit the CASE HISTORY list.
4.15.3 Exporting Case Histories
Using a USB flash drive, you can export individual or multiple cases from the case
history list, or you can export the case that you are viewing. After exporting cases,
you can upload them to a computer. See Downloading Case Histories to a USB Drive,
page 5-2 for information about data format, file names, and working with the data.
 Note:
Medtronic recommends incorporating appropriate security measures for any external
devices receiving patient data from the monitoring system.
To export one or more case histories from the case history list:
1. Make sure that the monitoring system is powered on but that no sensors are connect-
ed.
2. Press MENU.
3. Press CASE HISTORIES. The case history list appears.
4. Press the checkbox next to one or more cases to export.
5. Insert a USB flash drive into a USB port on the monitor or docking station. See Figure 2-
3 on page 2-5 and Figure 2-6 on page 2-8.
6. Press the Export button. A progress bar appears. Do not remove the USB drive while the
export is taking place.
7. When the export is complete, press FINISH or remove the USB drive.
8. Press CLOSE to exit the case history list.
9. If you have not already done so, remove the USB drive.
To export a case history that your are viewing:

1. Follow the steps in Viewing Case Histories, page 4-52, but do not close the case history
view.
2. Insert a USB flash drive into a USB port on the monitor or docking station. See Figure 2-
3 on page 2-5 and Figure 2-6 on page 2-8.
3. Press the Export button. A progress bar appears. Do not remove the USB drive while the
export is taking place.

Operation
4. When the export is complete, press FINISH or remove the USB drive to return to the case
history list.
5. Press CLOSE to exit the case history list.
6. If you have not already done so, remove the USB drive.

5 Data Management
5.1 Overview
This chapter explains how to display INVOS™ patient monitor screens on an external
monitor, download case data for storage and analysis on a computer, and transmit
real-time data to external devices such as a Philips multi-parameter system.
• Displaying Monitoring System Screens on an External Monitor, page 5-2
• Downloading Case Histories to a USB Drive, page 5-2
• Transmitting Monitoring System Data to External Devices via the Serial Port, page 5-3
• Data Formats, page 5-8
 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-
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.
5-1
Data Management
 WARNING:
5.3 Displaying Monitoring System Screens on an

External Monitor
To display monitoring system screens on an external monitor, use the VGA port on
the docking station (Figure 5-1). Using a VGA cable no longer than 50 feet (15.24 m),
connect the cable between the VGA port and the external monitor.
Figure 5-1. VGA Port on Docking Station
5.4 Downloading Case Histories to a USB Drive

Using a USB flash drive, you can download case histories from the monitoring
system for storage or later analysis on a computer. See Exporting Case Histories, page
4-55 for instructions. Downloaded case history data can be graphed using a com-
mercial spreadsheet program. See Case Histories Downloaded via USB, page 5-8 for
case history data format and file name information.
Use any of the USB ports on the monitor or docking station to download case histo-
ries. The monitor has one USB 2.0 and one USB 3.0 port (see Figure 2-3 on page 2-5).
The docking station has two USB 2.0 ports (see Figure 2-6 on page 2-8). Do not
connect any device other than a USB flash drive to the monitoring system's USB
ports.

Transmitting Monitoring System Data to External Devices via the Serial Port
 Note:
Medtronic recommends incorporating appropriate security measures for any external
devices receiving patient data from the monitoring system.
5.5 Transmitting Monitoring System Data to External

Devices via the Serial Port
To transmit monitoring system data to devices such as a Philips IVOI module or a
computer, use the serial port on the docking station (Figure 5-2). As described in the
following sections, real-time data can be transmitted for display on a Philips multi-
parameter system or similar systems. Data can also be transmitted during a case to
a computer for storage and later analysis.
 Note:
The monitoring system will also interface with multi-parameter systems that accept the
Philips VOI B module specified in Transmitting Real-Time Data to a Philips IntelliBridge™* and
VueLink™* Open Interface (IVOI) Module, page 5-5. Contact Medtronic Technical Services for
information about compatibility with other commercial devices. See Technical Services, page
1-7.
Figure 5-2. Serial Port on Docking Station
5.5.1 Serial Port Specifications
The monitoring system’s serial port uses the following protocol:

• Baud: 19200 for VUE LINK format; 9600 for PC LINK 1 and PC LINK 2 formats
• No parity

Data Management
• 8 data bits
• 1 stop bit
• Flow control: hardware
Pin-outs for the serial port are shown in Figure 5-3 and described in Table 5-1.
Figure 5-3. Serial Port Pin-Outs
Table 5-1. Serial Port Pin-Out Descriptions
Pin # Signal name Pin # Signal name
1 Data carrier detect 6 Data set ready
2 Receive data 7 Request to send
3 Transmit data 8 Clear to send
4 Data terminal ready 9 Ring indicator
5 Ground

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

VueLink™* Open Interface (IVOI) Module
 WARNING:
The following instructions explain how to transmit real-time data to a Philips IVOI
module for display on a Philips multi-parameter system. The data transmitted
includes rSO2 values, alarms, and status messages.
Hardware requirements for communicating with a Philips VueLink™* module or
Philips IntelliBridge™* EC10 module are described in Table 5-2.
Table 5-2. Hardware Requirements for Philips VueLink™* and IntelliBridge™* Communication
System Hardware requirements
Philips VueLink™* System - Philips VOI B module (Philips VueLink™* P/N M1032A #A05)
- Philips VOI/RS-232 Interface Cable (Philips VueLink™* P/N M1032 #K6B)
- VueLink™* adapter cable, DB25F to DB9F (Medtronic P/N VLI)
Philips IntelliBridge™* System - Philips IntelliBridge™* module (EC10)

- Philips Ethernet Cable
- Philips IntelliBridge™* EC5 Open Interface RS232 Cable
To set up communication with a Philips VueLink™* module:

1. Slide the Philips VOI B module into any of the open slots in the multi-parameter system,
making sure it locks into place.
2. Connect the VOI/RS-232 Interface Cable to the VOI B module.
3. Connect the VOI/RS-232 Interface Cable via the VueLink™* adapter cable to the serial
port on the monitoring system docking station (Figure 5-2 on page 5-3).
4. Tighten all screw locks at each connector junction.
5. Ensure that the Philips monitor and VOI B module are properly configured per Philips
instructions.

Data Management
6. Power on the monitoring system and set the serial port protocol to VUE LINK, as
described in the monitoring system's service manual. After the monitoring system
restarts, it begins communicating with the Philips monitor.
7. Begin a case as described in Set Up for Patient Monitoring, page 4-11.
To set up communication with a Philips IntelliBridge™* module:

1. Insert the Philips IntelliBridge™* EC10 module into any of the open slots in the multi-
parameter system, making sure it locks into place.
2. Connect the Ethernet cable to the IntelliBridge™* EC10 module.
3. Connect the other end of Ethernet cable to the IntelliBridge™* EC5 ID module.
4. Using the IntelliBridge™* EC5 Open Interface RS232 cable, connect the IntelliBridge™*
EC5 ID module to the serial port on the monitoring system docking station (Figure 5-2
on page 5-3).
5. Tighten all screw locks at each connector junction.
6. Ensure that the Philips monitor and IntelliBridge™* module are properly configured per
Philips instructions.
7. Power on the monitoring system and set the serial port protocol to VUE LINK, as
described in the monitoring system's service manual. After the monitoring system
restarts, it begins communicating with the Philips monitor.
5.5.3 Transmitting Case Data to a Computer
The following instructions explain how to transmit case data to a computer using a
null modem cable and a terminal emulation program such as Tera Term™* or Hyper-
Terminal™* programs.
Data is transmitted approximately once every second as the case progresses. Data
can be transmitted in two formats: PC LINK 1and PC LINK 2. Instructions for selecting
a format are provided in the monitoring system's service manual. See Case Data
Downloaded via Serial Port, page 5-10 for descriptions of the formats.
Null Modem Cable Requirements
A 9-pin to 9-pin null modem cable is required for transmitting case data to a com-
puter via the serial port.

The null modem cable must be no longer than 50 feet (15.24 m).
Refer to Figure 5-4 for acceptable 9-pin to 9-pin wiring configurations.
Figure 5-4. Null Modem Cable Diagram for Connection to Serial Port (Two Options)
1 Monitoring System Serial Port 3 Monitoring System Serial Port

(Option 1) (Option 2)
2 Computer (PC) COM Port 4 Computer (PC) COM Port

(Option 1) (Option 2)
Using a Terminal Emulation Program to Transmit Case Data to a Computer
The following procedure presents general steps for transmitting case data to a com-
puter using a terminal emulation program and a null modem cable. Steps will vary
among programs. Refer to the terminal emulation program’s instructions for specific
steps.

Data Management
To use a terminal emulation program to transmit data:

1. Connect the null modem cable to the serial port on the monitoring system docking
station (Figure 5-2 on page 5-3) and to a COM port on the computer.
2. Power on the monitoring system and set the serial port protocol to PC LINK 1 or PC LINK
2, as described in the monitoring system's service manual.
3. Set up the terminal emulation program (one-time set-up):
a. Power on the computer.

b. Open the terminal emulation program.
c. Set the inputs for the COM port:
• Bits per second: 9600 baud
• Data bits: 8
• Parity: None
• Stop bits: 1
• Flow control: hardware
5. When you are ready to transmit data from the monitoring system, open the terminal
emulation program.
6. In the terminal emulation program, begin the transfer and text capture. Specify a file
name and directory to save the file.
7. When monitoring is complete, end the transfer, disconnect, and close the terminal
emulation program.
5.6 Data Formats
5.6.1 Case Histories Downloaded via USB
Downloaded case history data can be accessed and graphed on a computer using
a commercial spreadsheet program.

Data Formats
File Name - Case History Downloads
Case histories downloaded to a USB flash drive are stored in individual files named
as follows (if not assigned a custom name):
CaseID__MonitorSerialNumber.H3
CaseID is the date and time the case started (YYYYMMDD_HHMM in 24-hour format).
For example, 20171023_0841.
An example file name is:
20171023_0841__GBA12P3023.H3
Data Format - Case History Downloads
Downloaded case history data is stored in ASCII format as a single line as shown
below. Each field is separated by two space characters. Data is transmitted on a per
channel basis (Channel 1 through Channel 4). See Table 5-3, page 5-10 for field
descriptions.
Column: A B C D E F G
Description: Version Date Time Ch 1 rSO2 Event Status Rsvd
Column (continued): H I J K
Description (continued): Ch 2 rSO2 Event Status Rsvd
Column (continued): L M N O
Column (continued): P Q R S
Column (continued): Terminating

character
Description (continued): 0x0A

Data Management
Table 5-3. Case History Downloads - Data Fields
Field Description
Version <major>.<minor>.<patch>.<build>/[event list version]/[output format version]

Example: 1.2.34.56/1/1
(For Medtronic use only)
Date Date of the reading

Format: MM/DD/YY
Time Time of the reading

Format: HH:MM:SS (24-hour format)
Ch n rSO2 rSO2 reading for channel n. (Integer)

Range: 15 to 95
0 = Channel not active
Event Current event. (Integer)

Range: 0 to 160, 252 to 254
See Event Codes for Data Downloads, page 5-13 for descriptions.
0 = No event
Status Current status. (Integer)

Range: 0 to 19
See Status Codes for Data Downloads, page 5-17 for descriptions.
0 = No status
Note: Status 21 is not stored in the export file.
Rsvd Zero, to maintain backwards compatibility.

(Reserved) Format: 0
5.6.2 Case Data Downloaded via Serial Port
During a case, data is transmitted in ASCII text-based streams in either of two user-
selectable formats: PC LINK 1 and PC LINK 2.
Data is transmitted as a single line of text, approximately once per second, as shown
below. Each field is separated by two space characters. Data is transmitted on a per
channel basis (Channel 1 through Channel 4). If a particular channel is not active, a
zero is sent for all the fields corresponding to that channel. See Table 5-4, page 5-12
for field descriptions.
Case data can be accessed and graphed on a computer using a commercial spread-
sheet program.

Data Formats
Data Format 1 - PC LINK 1

Column: A B C D E F G H I J K L M N
Description: Version Date Time Ch label rSO2 Event Status Baseline AUC UAL LAL A B Rsvd
Column (continued): O P Q R S T U V W X Y
Description (continued): Ch label rSO2 Event Status Baseline AUC UAL LAL A B Rsvd
Column (continued): Z AA AB AC AD AE AF AG AH AI AJ
Column (continued): AK AL AM AN AO AP AQ AR AS AT AU
Column (continued): AV AW AX AY
Description (continued): Ch 1 sensor ID Ch 2 sensor ID Ch 3 sensor ID Ch 4 sensor ID
Column (continued): Terminating character Terminating character
Description (continued): 0x0A 0x0D
Data Format 2 - PC LINK 2
Column: A B C D E F G H I
Description: Date Time rSO2 Event Status A B C Rsvd
Column (continued): J K L M N O P
Description (continued): rSO2 Event Status A B C Rsvd
Column (continued): Q R S T U V W
Column (continued): X Y Z AA AB AC AD
Column (continued): AE AF AG AH
Description (continued): Ch 1 sensor ID Ch 2 sensor ID Ch 3 sensor ID Ch 4 sensor ID
Column (continued): Terminating character Terminating character
Description (continued): 0x0A 0x0D

Data Management
Table 5-4. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields
Field Included in Included in Description

PC LINK 1 PC LINK 2
format format
Version  <major>.<minor>.<patch>.<build>/[event list version]/

[output format version]
Example: 1.2.34.56/1/1
(For Medtronic use only)
Date   Date of the reading

Format: MM/DD/YY
Time   Time of the reading

Format: HH:MM:SS (24-hour format)
Ch label  Range: A to Z, S1 to S4
rSO2   Current rSO2 reading for Channel. (Integer)

Range: 15 to 95
Event   An event that was marked between the last transmission and
this transmission. (Integer)
Range: 0 to 160, 252 to 254
See Event Codes for Data Downloads, page 5-13 for descrip-
tions.
0 = No event
Status   Current active status. (Integer)

Range: 0 to 21
See Status Codes for Data Downloads, page 5-17 for descrip-
tions.
0 = No status
Baseline  Current baseline value. (Integer)

Range: 15 to 95
AUC  Area Under the Curve. (Integer)

Range: 0 to 9999
UAL  Upper Alarm Limit. (Integer)

Range: 20 to 95
LAL  Lower Alarm Limit. (Integer)

Range: 15 to 90

Data Formats
Table 5-4. Case Data Downloads (PC LINK 1 and PC LINK 2) - Data Fields (Continued)
Field Included in Included in Description

PC LINK 1 PC LINK 2
format format
A   Zero, to maintain backwards compatibility.

Format: 0.0000
B   Zero, to maintain backwards compatibility.

Format: 0.0000
C  Zero, to maintain backwards compatibility.

Format: 0
Rsvd   Zero, to maintain backwards compatibility.

(Reserved) Format: 0
Channel n   String (14 characters) - if a sensor is connected.

sensor ID 0 = No sensor connected
5.6.3 Event Codes for Data Downloads
The following event codes apply to case histories downloaded from the monitoring
system via USB and case data transmitted via the monitoring system’s serial port.
Table 5-5. Data Downloads - Event Codes 1 to 40
Event code Description Event code Description
1 Miscellaneous 21 Afterload Reduction
2 Set Baseline 22 Blood Transfusion
3 Induction 23 Cardioversion
4 Sternotomy 24 Cell Saver Blood
5 Cannulate 25 Cerebral Perfusion On
6 On CPB 26 ECLS On
7 Cross Clamp On 27 FFP / Platelets
8 Cooling 28 Fluid/Volume Expander
9 Cardioplegia 29 Hemoconcentrate / MUF
10 Warming 30 Inotrope
11 Cross Clamp Off 31 Increase Anesthetic

Data Management
Table 5-5. Data Downloads - Event Codes 1 to 40 (Continued)
12 Off CPB 32 Increase CO2
13 Skin Closure 33 Increase FiO2
14 Arrhythmia 34 Increase Pump Flow
15 Circulatory Arrest 35 Paced
16 Hypocapnia 36 Reposition Cannula
17 Hypotension 37 Reposition Clamp
18 One Lung Ventilation 38 Reposition Head
19 Pump Flow Down 39 Reposition Heart
20 Reduced Venous Return 40 Vasopressor
41 Miscellaneous 61 Blood Transfusion
42 Set Baseline 62 Chest Closed
43 Enteral Feeding 63 Dialysis / CRRT
44 Extubated 64 Diuretic
45 Intubated 65 ECLS On
46 Reposition Patient 66 ECLS Circuit Change
47 Sensor Change 67 ECLS Off
48 Apnea 68 ET Tube Suctioned
49 Arrhythmia 69 Fluid Bolus
50 Bradycardia 70 FFP/Platelets
51 Cardiac Arrest 71 Hi Frequency Vent
52 ICP Changes 72 Hypothermia
53 LOC Changes 73 Inotrope
54 Painful Procedure 74 Nitric Oxide
55 Seizure Activity 75 Paralytic
56 Tamponade 76 PDA Ligated

Data Formats
Table 5-6. Data Downloads - Event Codes 41 to 80 (Continued)
57 Afterload Reduction 77 Prostaglandin
58 Anti-Arrhythmic 78 Sedation
59 Anti-Epileptic 79 Vasopressor
60 Anti-Pyretic 80 Ventilator Change
81 Miscellaneous 101 Balloon Inflated
82 Set Baseline 102 Balloon Deflated
83 Intubated 103 Blood Transfusion
84 Incision 104 EPD Deployed
85 Heparin Given 105 Fogarty Catheter In
86 Cannulate 106 FFP / Platelets
87 Clamp On Vessel 107 Hemostasis Device In
88 Suturing Vessel/Graft 108 IAB Catheter In/On
89 Clamp Off Vessel 109 IAB Catheter Out/Off
90 Decannulate 110 Increase Anesthetic
91 Extubated 111 Increase etCO2
92 Arrhythmia 112 Increase FiO2
93 Blood Loss 113 Shunt Flushed
94 Contrast Dye Injected 114 Shunt Open
95 Dissection 115 Shunt Repositioned
96 EEG Change 116 Stent Deployed
97 Hypotension 117 Thrombus Removed
98 Hypocapnia 118 Vasopressor
99 Shunt Clamped 119 Vasodilator
100 Thrombus Suspected 120 Vessel Repaired

Data Management
121 Miscellaneous 141 Seizure
122 Set Baseline 142 Anti-Arrhythmic
123 Physical Assessment 143 Anti-Epileptic
124 Reposition Patient 144 Blood Trans/Platelets
125 Heel Stick/Lab Draw 145 Cooling Cap On-Off
126 Suction ET Tube 146 Dialysis/CRRT
127 Weigh Patient 147 ECLS On
128 Enteral Feeding 148 ECLS Circuit Change
129 Extubated-Intubated 149 ECLS Off
130 Vent Change 150 Fluid Bolus
131 Conventional Vent 151 Fem Art CutDwn
132 Hi Frequency Vent 152 Hypothermia
133 Bag Mask Vent 153 Nitric Oxide On-Off
134 Hand Bag Vent 154 NG Tube In-Out
135 Sensor Change 155 Paralytic
136 Apnea/Bradycardia 156 Prostaglandin
137 Arrhythmia 157 OR Procedure Bedside
138 Cardiac Arrest/CPR 158 Sedation
139 ICP Changes 159 Vasopressor
140 LOC Changes 160 Whole Body Cooling
252 Begin Post Op
253 First Alert
254 Somatic First Alert

Data Formats
5.6.4 Status Codes for Data Downloads
The following status codes apply to case histories downloaded from the monitoring
system via USB and case data transmitted via the monitoring system’s serial port.
Table 5-9. Data Downloads - Status Codes
Status code Status message
1 SENSOR NOT CONNECTED
2 CHECK SENSOR
3 POOR SIGNAL QUALITY
4 SYSTEM SIGNAL OK
5 HIGH rSO2
6 LOW rSO2
11 PREAMP NOT CONNECTED
17 REPLACE SENSOR
19 INTERFERENCE DETECTED
21 AUTO BASELINE SET
 Note:
The following alarms are not reported in downloaded data:
• BATTERY CRITICALLY LOW
• BATTERY FAILURE
• BATTERY LOW
• PREAMP FAILURE
• SYSTEM FAILURE
• TREND DATA LOST

Data Management

6 Performance Considerations
6.1 Overview
This chapter contains information about optimizing the performance of the INVOS™
patient monitor (the “monitoring system”).
• Patient Conditions, page 6-2
• Sensor Use Considerations, page 6-2
• EMI (Electromagnetic Interference), page 6-2
 WARNING:
 WARNING:
6-1
Performance Considerations
6.3 Patient Conditions

Certain patient conditions can cause poor performance of the monitoring system:
• Cardiogreen, indigo carmine, methylene blue, or other intravascular dyes
• Carboxyhemoglobin or other dyshemoglobins
• Hemoglobinopathies
• Conjugated hyperbilirubinemia (direct)
• Myoglobin (Mb), hemoglobin from muscular tissue, in the blood
• Dark skin pigment
• Externally applied coloring agents (dye, pigmented cream)
6.4 Sensor Use Considerations

Select an appropriate INVOS™ rSO2 sensor, apply it as directed, and observe all warn-
ings and cautions in the Instructions for Use accompanying the sensor.
A variety of sensor use situations can cause poor measurement performance, includ-
ing incorrect site selection, patient preparation, and sensor placement. Refer to the
sensor Instructions for Use for detailed information.
6.5 EMI (Electromagnetic Interference)
 WARNING:
critical devices.
 WARNING:

EMI (Electromagnetic Interference)
 WARNING:
 WARNING:
 WARNING:
 WARNING:
operate correctly.
 WARNING:
 WARNING:
 Caution:
installation.
 Caution:

Performance Considerations
 Caution:
 Caution:
readings at all.
Because of the proliferation of radio frequency transmitting equipment and other
sources of electrical noise in health care environments (for example, electrosurgical
units, cellular phones, mobile two-way radios, electrical appliances, and high-defini-
tion television), it is possible that high levels of such interference due to close prox-
imity or strength of a source may result in disruption of monitoring system
performance. Reference Manufacturer’s Declaration, p. 11-7.
Disruption may be evidenced by cessation of operation or other incorrect function-
ing. If this occurs, survey the site of use to determine the source of this disruption,
then take the appropriate actions to eliminate the source.
• Turn equipment in the vicinity off and on to isolate the interfering equipment.
• Reorient or relocate the interfering equipment.
• Increase the separation between the interfering equipment and the monitoring system.
• Connect the monitoring system to an outlet on a different circuit from the other
device(s).
• Have an authorized technician check the line frequency setting for the monitoring
system. The setting should match the AC power line input. Refer to the monitoring sys-
tem's service manual.
if not installed and used in accordance with these instructions, may cause harmful
interference with other susceptible devices in the vicinity. Contact Technical Ser-
vices for assistance. Reference Obtaining Technical Assistance, p. 1-7.

7 Product Maintenance
7.1 Overview
This chapter describes the steps required to properly clean the INVOS™ patient
monitor (the “monitoring system”). It also provides information about periodic safety
checks, service, software and firmware upgrades, and component disposal.
• Cleaning the Monitoring System, page 7-2
• Maintenance Schedule, page 7-3
• Service and Calibration, page 7-4
• Service Life, page 7-4
• Software and Firmware Updates, page 7-4
• Recycling and Disposal, page 7-5
 WARNING:
 WARNING:
 WARNING:
7-1
Product Maintenance
 Caution:
 Caution:
 Caution:
7.3 Cleaning the Monitoring System
 WARNING:
 Caution:
 Caution:
7.3.1 Materials
• Lint-free cloths
• Water
• Sodium hypochlorite (8.25% household bleach diluted 1:500 with tap water)
• Quaternary ammonium germicidal detergent (PDI Sani-Cloth™* AF3)
• Phenolic germicidal detergent (Lysol™* concentrate diluted 1:100 with tap water)
• CaviCide™* disinfectant (Metrex CaviWipes™*)

Maintenance Schedule
7.3.2 Procedure
 Note:
Follow recommended cleaning procedures for your institution.
To clean the monitoring system:
1. Power off the monitoring system and disconnect AC power.
2. Clean the outside surface of all monitoring system components with a cloth dampened
with a cleaning agent or a pre-moistened wipe.
3. Clean the faceplate and screen. Do not use acetone or abrasives.
4. Allow the monitoring system to completely dry before reconnecting AC power or

returning to use.
7.4 Maintenance Schedule

In the case of mechanical or functional damage or to schedule regular maintenance
and safety checks, contact Medtronic or a local Medtronic representative. See
Obtaining Technical Assistance, page 1-7.
Medtronic recommends the following checks at the indicated intervals.
Table 7-1. Maintenance Schedule
How often What to do
Each power-up Confirm speaker operation. 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. See Apply Power, page 3-13.
Every 3 months If the monitoring system is not in use, apply power and charge the battery.
For long-term storage, Medtronic recommends removing the battery pack
from the monitor.
Annually Check the INVOS™ system. The monitoring system's service manual provides
annual inspection procedures to be followed by an authorized technician.
Annually Inspect all safety relevant labels for legibility. Contact Medtronic or a local
Medtronic representative, if labels are damaged or illegible.
Annually Replace the reusable sensor cables (RSCs). See Accessories/Parts List, page 9-2
for part number and ordering information.

Product Maintenance
Table 7-1. Maintenance Schedule (Continued)
How often What to do
Every 2 years Replace the monitor’s battery. See Accessories/Parts List, page 9-2 for part
number and ordering information.
After approximately Replace the monitor. See Service Life, page 7-4 for more information.
25,000 hours of operation
7.5 Service and Calibration

The monitoring system requires no routine service other than cleaning.
The monitoring system requires no calibration.
If service is necessary, contact Technical Services. See Obtaining Technical Assistance,
page 1-7.
7.6 Service Life

Discontinue use of the monitoring system if the system reports any unrecoverable
technical alarms, the monitor is inoperative, or visible damage is present.
Service life of specific components:
• The monitor’s battery has a service life of approximately two years.
• The reusable sensor cables have a service life of approximately one year.
• The preamplifiers have a service life of approximately five years.
• The monitor’s LCD panel (screen) has a service life of approximately 25,000 hours of
operation before the brightness is reduced to approximately 50% of initial brightness.
To avoid difficulty reading the screen, Medtronic recommends replacing the monitor at
approximately 25,000 hours of operation.
7.7 Software and Firmware Updates

Medtronic may provide platform software or firmware updates periodically. Updates
must be performed by Medtronic personnel. To inquire about updates, contact
Medtronic or a local Medtronic representative. See Obtaining Technical Assistance,
page 1-7.

Recycling and Disposal
7.8 Recycling and Disposal
 Caution:
Follow local government ordinances and recycling instructions regarding disposal
or recycling of the monitoring system and its components, including its battery and
accessories.

Product Maintenance

8 Alarms and Troubleshooting
8.1 Overview
This chapter describes alarms generated by the INVOS™ patient monitor (the “mon-
itoring system”) and explains how to troubleshoot other errors that might occur.
• Alarm Messages, page 8-2
• Error Conditions, page 8-7
• Product Return, page 8-11
8-1
Alarms and Troubleshooting
8.2 Alarm Messages

Technical vs. Physiological Alarms - All monitoring system alarms are technical
except the following which are physiological:
• LOW RSO2
• HIGH RSO2
Non-Latching vs. Latching Alarms - The monitoring system terminates non-latch-

ing alarms within five seconds after the alarm condition no longer exists. Latching
alarms must be acknowledged by the user. All monitoring system alarms are non-
latching except the following:
• SYSTEM FAILURE
Table 8-1. Alarm Conditions
Alarm Condition Priority Audio/ Dismis- Resolution

visual sible
BATTERY CRITI- System is using battery Medium Audio1 No Immediately connect to AC

CALLY LOW power AND battery and visual power.
level is Critical (<5% If the battery does not charge,
charge remaining). contact Medtronic or a local
Medtronic representative.
BATTERY Battery is malfunction- Low Visual No Make sure that the battery is
FAILURE ing. only present and that the latch is in the
locked position. Try removing
and reinstalling the battery. See
Install the Battery, page 3-7.
If the battery is in place and
locked, discontinue use of the
monitor.
BATTERY LOW System is using battery Medium Audio Yes Connect to AC power as soon as
power AND battery and visual possible.
level is Low (<33% If the battery does not charge,
charge remaining). contact Medtronic or a local
Medtronic representative.

Alarm Messages
Table 8-1. Alarm Conditions (Continued)

visual sible
CHECK SENSOR Sensor is not attached Medium Audio No Make sure the sensor is securely
to patient. and visual adhered to the patient. If neces-
OR sary, replace the sensor.
Excessive light is detect- Under high ambient light condi-
ed on a sensor channel. tions, loosely cover the sensor
with opaque material.
OR
Identify any possible sources of
Electrical interference.
interference, and take the actions
OR recommended in EMI (Electro-
Moisture in connector. magnetic Interference), page 6-2.
OR Try another hospital-grade elec-
Sensor applied over trical outlet.
nevi, sinus cavities, the Have an authorized technician
superior sagittal sinus, check the line frequency setting
subdural or epidural for the monitoring system. The
hematomas, arteriove- setting should match the AC
nous malformations, power line input. Refer to the
broken skin, thick fatty monitoring system's service
deposits, hair, bony pro- manual.
tuberances, or areas Ensure sensor and RSC connec-
contaminated with resi- tors are moisture-free.
due.
Check sensor site. Refer to the
sensor Instructions for Use for site
selection information.
If the problem persists, contact
Medtronic or a local Medtronic
representative.
HIGH RSO2 Upper rSO2 alarm limit is Medium Audio No Immediately check the patient.
exceeded. and visual
INTERFERENCE Interference on a sensor Medium Audio No Move or turn off the source of
DETECTED channel is corrupting and visual interference. Normal operation
the rSO2 data. will resume when the excessive
noise stops. See EMI (Electromag-
netic Interference), page 6-2.
Have an authorized technician
check the line frequency setting
for the monitoring system. The
setting should match the AC
power line input. Refer to the
monitoring system's service
manual.


visual sible
LOW RSO2 Lower rSO2 alarm limit is Medium Audio No Immediately check the patient.
exceeded. and visual
POOR SIGNAL Poor signal quality is Medium Audio No Identify any possible sources of
QUALITY detected on a sensor and visual interference, and take the actions
channel. rSO2 values will recommended in EMI (Electro-
not be displayed due to: magnetic Interference), page 6-2.
Electrical interference. Try another hospital-grade elec-
trical outlet.
OR
Under high ambient light condi-
Incorrect line frequency tions, loosely cover the sensor
setting. with opaque material.
OR Have an authorized technician
Moisture in connector. check the line frequency setting
OR for the monitoring system. The
setting should match the AC
Sensor applied over
power line input. Refer to the
nevi, sinus cavities, the
monitoring system's service
superior sagittal sinus,
manual.
subdural or epidural
hematomas, arteriove- Ensure sensor and RSC connec-
nous malformations, tors are moisture-free.
broken skin, thick fatty Check sensor site. Refer to the
deposits, hair, bony pro- sensor Instructions for Use for site
tuberances, or areas selection information.
contaminated with resi- Replace sensor.
due.
Replace RSC.
OR
If the problem persists, contact
Defective sensor. Medtronic or a local Medtronic
OR representative.
Defective RSC.

Alarm Messages

visual sible
PREAMP Preamplifier is not com- Medium Audio1 No If you are using two preamplifiers,
FAILURE municating with the and visual determine which preamplifier is
system as expected. generating the alarm by touching
OR each sensor label on the monitor-
ing screen and noting whether
Preamplifier is generat-
the corresponding LED on the
ing unrecoverable
preamplifier flashes. If an LED
errors.
does not flash on a preamplifier,
disconnect the preamplifier cable
from the monitor and reconnect
it. See Connect the Preamplifier(s),
page 3-11.
If the problem persists, replace
the preamplifier. Contact
Medtronic or a local Medtronic
representative.
PREAMP NOT Preamplifier becomes Medium Audio Yes Make sure the preamplifier con-
CONNECTED disconnected from the and visual nector is locked into the monitor.
monitor during use. See Connect the Preamplifier(s),
page 3-11. Normal operation will
resume when the preamplifier is
reconnected.
REPLACE Sensor incompatible Medium Audio No Make sure that all sensors match
SENSOR OR and visual and are compatible with the
monitoring system. See the
Invalid calibration data
Instructions for Use provided with
OR the sensors.
Bad sensor Replace the sensor(s) if necessary.
OR Replace the RSC(s) if necessary.
Open/short condition
OR
Unable to access sensor
memory
SENSOR NOT Sensor is disconnected Medium Audio Yes Check the connection between
CONNECTED from the RSC. and visual the sensor and RSC and between
OR the RSC and preamplifier. If the
problem persists, replace the RSC
RSC is disconnected
and/or the sensor.
from the preamplifier.


visual sible
SYSTEM ERROR Sensor is connected to a Medium Audio1 No Power the monitoring system off
patient, but the rSO2 and visual and back on.
data display has not If the problem persists, contact
been updated for over Medtronic or a local Medtronic
30 seconds. representative.
The system may indi-
cate that settings are
corrupted.
SYSTEM Monitoring system was Medium Audio1 Yes Power the monitoring system off
FAILURE reset unexpectedly. and visual and back on.
Note: All settings may If the problem persists, contact
be lost. Medtronic or a local Medtronic
representative.
TREND DATA Software was upgraded. Low Audio Yes If the problem persists, contact
LOST OR and visual Medtronic or a local Medtronic
representative.
Time setting was
changed.
OR
Corrupt trend data was
detected at start up.
1. Sounds even when alarms are silenced or paused.

Error Conditions
8.3 Error Conditions

If resolutions don’t work, contact Technical Services (Obtaining Technical Assistance,
page 1-7).
Table 8-2. Error Conditions and Resolutions
Problem Resolution
No AC power to monitoring system • Make sure that the monitoring system’s power supply is
when plugged in and powered on plugged into a hospital-grade power outlet.
(runs on battery power only)
• Make sure that the power cord is securely connected to the
power supply and that the power supply is securely connected
to the docking station.
• Check that the AC indicator on the docking station is illuminat-

ed. See Apply Power, page 3-13.
• Make sure that the monitor is completely seated in the docking

station. See Insert the Monitor into the Docking Station, page 3-9.
• If the problem persists, contact Medtronic or a local Medtronic

representative.
Does not power up when power • Press the power button for more than 3 seconds.
button is pressed
• If operating on AC power, refer to the resolutions above.
• If operating on battery power, make sure that the battery latch

is in the locked position. See Install the Battery, page 3-7.
• If operating on battery power, the battery may be discharged.

Connect to AC power to charge the battery. See Apply Power,
page 3-13.
System indicates a preamplifier has • Check the preamplifier connection to the monitor. See Connect
been disconnected when it is still the Preamplifier(s), page 3-11.
physically connected
• Try a different preamplifier.
Error message:
PREAMP NOT CONNECTED • Contact Medtronic or a local Medtronic representative.
System does not recognize and • Check the preamplifier connection to the monitor. See Connect
gives no indication a preamplifier the Preamplifier(s), page 3-11.
has been connected after it has
been physically connected • Try a different preamplifier.
• Contact Medtronic or a local Medtronic representative.

Table 8-2. Error Conditions and Resolutions (Continued)
Problem Resolution
Does not power off when power • If the monitoring system does not power off within approxi-
button is pressed mately 30 seconds after you press the Power button, press and
hold the Power button for at least 10 seconds to power off the
monitoring system.
Electrical noise on AC power line • Have an authorized technician check the line frequency setting
causing poor signal quality for the monitoring system. The setting should match the AC
power line input. Refer to the monitoring system's service
manual.
Multiple, consecutive sensor alarms If sensor alarms continue to occur after you have performed the rec-
ommended corrections for the alarms (see Table 8-1, page 8-2),
replace the following:
• RSCs
• Preamplifiers
Displayed rSO2 value is 0 with • Replace the sensor.

sensor properly applied to a patient
according to the sensor Instructions
for Use
Frequent battery alarms • Replace the battery. See Install the Battery, page 3-7.
Touch screen is unresponsive • Power the monitoring system off and back on.
• If the problem persists, contact Medtronic or a local Medtronic

representative.

Error Conditions
Problem Resolution
A USB error occurs during any of the • Follow the resolution indicated in the error message.
following situations:
• If a USB flash drive is present but isn’t recognized by the system,
• Exporting case histories
make sure that the drive has been formatted. If necessary, you
• Exporting logs can format the drive on a computer running Microsoft Win-
dows™*.
• Exporting or importing system
settings
• Importing firmware or soft-

ware
Possible error messages include:

• USB DRIVE NOT FOUND.
INSERT USB DRIVE AND TRY
AGAIN.
• USB DRIVE ERROR. CHECK USB

DRIVE AND TRY AGAIN.
• MULTIPLE USB DRIVES FOUND.

REMOVE EXTRA USB DRIVES
AND TRY AGAIN.
• INSUFFICIENT STORAGE
SPACE. INSERT NEW USB
DRIVE AND TRY AGAIN.
• NO FIRMWARE UPDATE
FOUND. CHECK USB DRIVE
AND TRY AGAIN.
• NO SOFTWARE UPDATE
FOUND. CHECK USB DRIVE
AND TRY AGAIN.

Problem Resolution
Unable to consistently display • Make sure that the monitor is completely seated in the docking
monitoring system screens to an station. See Insert the Monitor into the Docking Station, page 3-9.
external monitor
• Disconnect the VGA cable from the docking station and external
monitor. Reconnect the cable, making sure it is completely
seated at both connections.
• Verify that the power cord is fully plugged into the monitor’s
docking station.
• Verify that the external monitor is connected to power.
• Verify that the VGA cable meets the requirements described in

Displaying Monitoring System Screens on an External Monitor,
page 5-2.
• Power the monitoring system off and back on.
No data received or data scrambled • Make sure that the monitor is completely seated in the docking
during serial port transmissions station. See Insert the Monitor into the Docking Station, page 3-9.
• Disconnect the serial cable from the docking station and exter-
nal device. Reconnect the cable, making sure it is completely
seated at both connections.
• Verify that the power cord is fully plugged into the monitor’s
docking station.
• Have an authorized technician check the serial port format for

the monitoring system. The format must be set correctly for the
type of transmission. Refer to the monitoring system's service
manual.
• If transmitting data, verify that the serial cable meets the require-
ments described in Serial Port Specifications, page 5-3 and Null
Modem Cable Requirements, page 5-6.
• If using a terminal emulation program to receive data from the

monitor, verify that the terminal emulation program settings are
correct. See Using a Terminal Emulation Program to Transmit Case
Data to a Computer, page 5-7.
• Make sure that the system is monitoring (the monitoring screen

is displayed). The monitoring system does not transmit data
when the Set-up screen is displayed.
• Power the monitoring system off and back on.

Product Return
8.4 Product Return

Contact Medtronic or a local Medtronic representative for shipping instructions,
including a Returned Goods Authorization (RGA) number. Reference Obtaining Tech-
nical Assistance, p. 1-7. Pack the monitoring system in its original shipping carton. If
the original carton is not available, use a suitable carton with the appropriate
packing material to protect it during shipping. Return the monitoring system by any
shipping method that provides proof of delivery.


9 Accessories
9.1 Overview
This chapter contains information for selecting the appropriate rSO2 sensor and
other accessories for use with the INVOS™ patient monitor (the “monitoring sys-
tem”).
• Safety Reminder, page 9-1
• Accessories/Parts List, page 9-2
9.2 Safety Reminder
 WARNING:
9-1
Accessories
9.3 Accessories/Parts List

Contact Medtronic or a local Medtronic representative to order accessories. See
Technical Services, page 1-7.
Table 9-1. Monitoring System Accessory Part Numbers
Part number Item
PMSENS71-A INVOS™ adult rSO2 sensor
PMAC71DOC INVOS™ docking station
PMAC71STAND INVOS™ patient monitor stand
PMAC71RSC INVOS™ reusable sensor cable for PM7100
PMAC71BAT INVOS™ PM7100 battery
PMAC71PS INVOS™ PM7100 power supply
VLI INVOS™ rSO2 interface cable (VueLink™* adapter cable, DB25F to DB9F)

10 Theory of Operations
10.1 Overview
This chapter explains the theory behind operations of the INVOS™ patient monitor
(the “monitoring system”).
10.2 Theoretical Principles

The INVOS™ system “reflects the color of life.” The near-infrared wavelengths gener-
ated by the INVOS™ system’s light-emitting diodes (LEDs) pass through scalp and
bone tissue beneath the sensor. Once in vivo they are either absorbed or scattered
back up to the sensor’s shallow and deep detectors. Other than variations in the
thickness and composition of the tissue layers, somatic and cerebral measurements
are quite similar.
Red-colored hemoglobin molecules within red blood cells have the highest light
absorption of the wavelengths used, and the exact shade of red of each hemoglobin
molecule indicates the amount of oxygen it is carrying.
The type and quantity of absorption data returned to the detectors reflects relative
amounts of deoxyhemoglobin and total hemoglobin, from which a regional oxygen
saturation (rSO2) value unique to the specific area under the sensor is calculated.
Values are measured continuously, with screen updates provided to clinicians every
second.
10-1
Theory of Operations

11 Product Specifications
11.1 Overview
This chapter contains physical and operational specifications for the
INVOS™ patient monitor (the “monitoring system”).
• Physical Characteristics, page 11-2
• Electrical, page 11-3
• Battery, page 11-3
• Environmental Conditions, page 11-4
• Alarm Audio and Visual Characteristics, page 11-4
• Sensor Operating Range, page 11-6
• Equipment Classifications, page 11-6
• Biocompatibility Testing, page 11-7
• Manufacturer’s Declaration, page 11-7
• Essential Performance, page 11-14
11-1
Product Specifications
11.2 Physical Characteristics
Monitor
Dimensions 20 x 30.75 x 5.1 cm (7.87 x 12.1 x 2 in.)
Weight 1270 g (2.8 lb)
Screen size 25.7 cm (10.1 in.), measured diagonally
Screen type TFT LCD, projected capacitive multi-touch
Resolution 1280 x 800 pixels
Visibility Visual communication of parameter values and alarms is visible by an

operator with 20/20 vision (corrected as necessary) from a distance of 1
meter when the monitor is placed in an environment with ambient
light in the range of 100 to 1500 lux and the operator’s position is any-
where on or within the base of a cone subtended by an angle of 30º
normal to the center of the plane of display of the monitor. Visual com-
munication of parameter alarm priority is visible under the same condi-
tions from 4 meters.
Buttons Power on/off
Power AC power adapter, Li-ion battery
Ports USB 3.0, USB 2.0, DC In, docking port
Indicators Power/battery, hard disk activity, wireless
Docking Station
Type VESA™*
Dimensions 22.47 x 20 x 5.64 cm (8.85 x 7.87 x 2.22 in.)
Indicator Power
Ports DC In, USB 2.0 (x2), serial (RS-232), and VGA ports
Stand
Dimensions 24.3 x 31.1 x 26.8 cm (9.58 x 12.25 x 10.57 in.)
Preamplifier
Dimensions 12.8 x 8.7 x 2.8 cm (5.04 x 3.43 x 1.1 in.) with hook folded down
Weight 294 g (0.65 lb)
Indicators Reusable sensor cable (RSC) connection prompt
Preamplifier cable length 428.4 cm (14 ft) (approximate)
Preamplifier cable connector Amphenol 8-pin

Electrical
Reusable sensor cable (RSC)
Length 162 cm (5.3 ft) (approximate)
Indicators Sensor connection prompt
Power cable
Length International: 2.5 m

US: 10 ft
11.3 Electrical
Power 100 VAC to 240 VAC ±10%
Input frequency 50 Hz to 60 Hz
11.4 Battery
Type Lithium-ion
Voltage 11.1 VDC
Capacity 31.7 Whrs (11.1V 2860mAh)
Operating time 1 hour under normal monitoring conditions
Recharge 24 hours
Compliance IEC 62133:2012, EN 62133: 2013

UL2054 2nd Edition, UL 60950-1 2nd Edition
CAN/CSA C22.22 No. 60950-1-07 2nd Edition
UN 38.3 Rev 5, Amd 1
PSE

11.5 Environmental Conditions
 Note:
The system may not meet its performance specifications if stored or used outside the
specified temperature and humidity range.
Table 11-1. Transport, Storage, and Operating Condition Ranges
Transport and storage Operating conditions
Temperature -20ºC to 45ºC, 10ºC to 35ºC

(-4ºF to 113ºF) (50ºF to 95ºF)
Altitude -500 m to 6100 m -500 m to 4000 m

(-1640 ft to 20013 ft) (-1640 ft to 13123 ft)
Atmospheric 1075 hPa to 465 hPa 1075 hPa to 616 hPa

pressure (32 in. Hg to 14 in. Hg) (32 in. Hg to 18 in. Hg)
Relative 10% to 95% non-condensing 15% to 95% non-condensing

humidity
11.6 Alarm Audio and Visual Characteristics
Alarms
Categories Physiological (patient status) and technical (system status)
Priorities Medium and low
Notifications Audible and visual
Alarm volume level Adjustable 1 to 10

15 to 45 dB
Alarm system delay None
Alarm reminder signal Once every 3 minutes ±10 seconds

Three pulses in burst

Alarm Audio and Visual Characteristics
11.6.1 Alarm Audio Characteristics
Table 11-2. Alarm Audio Characteristics
Sound Number Pitch (Hz) Effective Rise/fall Inter-pulse spacing Number of

of pulse time (ms) harmonic
pulses duration (ms) compo-
in burst (ms) nents
Medium 3 525 144.9 Rise: 19.2 Between pulse 1 and 2: >4

priority Fall: 12 188.1
alarm Between pulse 2 and 3:
188.1
Low 2 Pulse 1: 660 186.9 Rise: 19.2 Between pulse 1 and 2: >4
priority Pulse 2: 525 Fall: 12 188.1
alarm
Table 11-3. Average Alarm Sound Pressure Levels
Alarm Volume = 1 Volume = 5 (default) Volume = 10
Medium priority 21 dB 33 dB 38 dB
Low priority 19 dB 29 dB 35 dB
11.6.2 Alarm Visual Characteristics
Table 11-4. Alarm Visual Characteristics
Alarm Color Flashing frequency1 Duty cycle

(Hz)
Medium priority Yellow 0.5 50%
Low priority Yellow None 100%

1. Alarm visual flashing alternates between the original color (brightness = 100%) and a darker shade of the same color
(brightness = 70%).

11.6.3 POST Pass Tone
Table 11-5. POST Pass Tone Characteristics
POST pass tone
Volume level Not changeable
Number of pulses N/A
Repetitions No repeat
11.7 Sensor Operating Range
Table 11-6. INVOS™ Adult rSO2 Sensor Operating Range
Operating Range
Four-wavelength LEDs Approximately 700 nm to 900 nm
11.8 Equipment Classifications
Type of protection against electric shock Class I and internally powered
Degree of protection against electric shock Defibrillation-proof type BF applied part
Mode of operation Continuous
Electromagnetic compatibility IEC 60601-1-2:2007 and IEC 60601-1-2:2014
Ingress protection IPX2
Degree of safety Not suitable for use in the presence of flammable anes-
thetics

Biocompatibility Testing
11.9 Biocompatibility Testing

Biocompatibility testing has been conducted on INVOS™ sensors in compliance
with ISO 10993-1:2009, Biological Evaluation of Medical Devices, Part 1: Evaluation
and Testing. INVOS™ sensors have passed the recommended biocompatibility
testing and are therefore in compliance with ISO 10993-1:2009.
11.10 Manufacturer’s Declaration
 WARNING:
critical devices.
 WARNING:
 WARNING:
 WARNING:
 WARNING:
 WARNING:

operate correctly.
 WARNING:
 WARNING:
 Caution:
installation.
 Caution:
 Caution:
 Caution:
readings at all.

Manufacturer’s Declaration
11.10.1 Electromagnetic Compatibility (EMC)
The monitoring system is suitable for prescription use only in the specified electro-
magnetic environments, in accordance with the IEC/EN 60601-1-2:2007 and IEC/EN
60601-1-2:2014 standards. The monitoring system requires special precautions
during installation and operation for electromagnetic compatibility. In particular, the
use of nearby mobile or portable communications equipment may influence mon-
itoring system performance.
 Note:
The emissions characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such
as relocating or re-orienting the equipment.
Electromagnetic Emissions Guidelines and Compliance
Table 11-7. Electromagnetic Emissions Guidelines and Compliance
Guidance and manufacturer’s declaration—electromagnetic emissions
The monitoring system is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitoring system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment guidance
Radiated emission CISPR 11/EN The monitoring system uses RF energy only for its internal
55011, Class A, function. Therefore, its RF emissions are very low and are not
Group 1 likely to cause any interference in nearby electronic equip-
ment.
Conducted emission CISPR 11/EN The monitoring system is suitable for use in all establish-
55011, Class A, ments other than domestic and those directly connected to
Group 1 the public low-voltage power network that supplies build-
ings used for domestic purposes.
Harmonic emission IEC/EN 61000-3-2,
Class A
Voltage fluctuations/ IEC/EN 61000-3-3,

flicker emission Section 4

Electromagnetic Immunity Guidelines and Compliance
Table 11-8. Electromagnetic Immunity Guidelines and Compliance
Guidance and manufacturer’s declaration—electromagnetic immunity
The monitoring system is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitoring system should assure that it is used in such an environment.
Immunity IEC/EN 60601-1-2 Compliance Electromagnetic environment

test test level level guidance
Electrostatic ± 8 kV contact ± 8 kV contact Floor should be wood, concrete, or

discharge (ESD) ± 15 kV air ± 15 kV air ceramic tile. If floors are covered
IEC/EN 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electric fast ± 2kV (100 kHz repeti- ± 2kV (100 kHz repeti- Mains power quality should be that
transient/burst tion rate) AC mains tion rate) AC mains of a typical commercial or hospital
IEC/EN 61000-4-4 ± 1kV (100 kHz repeti- ± 1kV (100 kHz repeti- environment.
tion rate) input/ tion rate) input/
output >3 m output >3 m
Surge ± 1kV line-line, AC ± 1kV line-line, AC Mains power quality should be that
IEC/EN 61000-4-5 mains mains of a typical commercial or hospital
± 2kV line-ground, AC ± 2kV line-ground, AC environment.
mains mains
Voltage dips and 100% reduction for 0.5 100% reduction for 0.5 Mains power quality should be
interrupts cycles (at 0°, 45°, 90°, cycles (at 0°, 45°, 90°, that of a typical commercial or
IEC/EN 61000-4-11 135°, 180°, 225°, 270°, 135°, 180°, 225°, 270°, hospital environment.
and 315°) and 315°) If the user requires continued
100% reduction for 1.0 100% reduction for 1.0 operation during power mains
cycle (at 0°) cycle (at 0°) interruptions, it is recommended
30% reduction for 25/ 30% reduction for 25/ that the monitoring system be
30 cycles (at 0°) 30 cycles (at 0°) powered from an uninterruptible
power supply or battery.
100% reduction for 100% reduction for
250/300 cycles (at 0°) 250/300 cycles (at 0°)
Power frequency 50 and 60 Hz, 30 A/m, 50 and 60 Hz, 30 A/m, Power frequency magnetic fields
H-field immunity x-, y-, and z-axes x-, y-, and z-axes should be at levels characteristic of
IEC/EN 61000-4-8 a typical location in a typical com-
mercial or hospital environment.

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

The monitoring system is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitoring system should assure that it is used in such an environment.
Immunity IEC/EN 60601-1-2 Compliance Electromagnetic
test test level level environment guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment should be
IEC/EN 150 kHz to 150 kHz to used no closer to any part of the monitoring system, including
61000-4-6 80 MHz; 80 MHz; cables, than the recommended separation distance calculated
6 Vrms, ISM and 6 Vrms, ISM and from the equation applicable to the frequency of the transmitter.
amateur radio amateur radio Recommended separation distance
bands between bands between
0.15mHz and 0.15mHz and d = 1.2 P
80MHz frequencies 80MHz frequencies
150 kHz to 80 MHz
where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked with
the following symbol:

Table 11-9. Recommended Separation Distance Calculations (Continued)

The monitoring system is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitoring system should assure that it is used in such an environment.
Immunity IEC/EN 60601-1-2 Compliance Electromagnetic
test test level level environment guidance
Radiated RF 3 V/m 3 V/m Portable and mobile RF communications equipment should be
IEC/EN 80 MHz to 80 MHz to used no closer to any part of the monitoring system, including
61000-4-3 2.7 GHz 2.7 GHz cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveya, should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked with
the following symbol:
RF wireless See Table 11-10 on See Table 11-10 on 0.3 m

proximity fields page 11-13 page 11-13
IEC/EN
61000-4-3
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects, and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the mea-
sured field strength in the location in which the monitoring system is used exceeds the applicable RF compliance level above,
the monitoring system should be observed to verify normal operation. If abnormal performance is observed, additional mea-
sures may be necessary, such as re-orienting or relocating the monitoring system.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 11-10. Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment
Test Band Service Modulation Max. Dis- Immunity

frequency (MHz) power tance test level
(MHz) (W) (m) (V/m)
385 380 to 390 TETRA 400 Pulse modulation 1.8 0.3 27

18 Hz
450 430 to 470 GMRS 460, FRS 460 FM 2 0.3 28

± 5kHz deviation
1 kHz sine
710 704 to 787 LTE Band 13, 17 Pulse modulation 0.2 0.3 9
217 Hz
745
780
810 800 to 960 GSM 800/900, TETRA Pulse modulation 2 0.3 28

800, iDEN 820, CDMA
870 18 Hz
850, LTE Band 5
930
1720 1700 to GSM 1800; CDMA Pulse modulation 2 0.3 28

1990 1900; GSM 1900; 217 Hz
1845 DECT; LTE Band 1, 3,
4, 25; UMTS
1970
2450 2400 to Bluetooth, WLAN, Pulse modulation 2 0.3 28

2570 802.11 b/g/n, RFID 217 Hz
2450, LTE Band 7
5240 5100 to WLAN 802.11 a/n Pulse modulation 0.2 0.3 9

5800 217 Hz
5500
5785

Recommended Separation Distances
Table 11-11. Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment

and the monitoring system
The monitoring system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the monitoring system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the monitoring system as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter in meters

output power (P) of
transmitter in watts d = 1.2 P d = 1.2 P d = 2.3 P
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
0.01 0.12 0.12 0.23
0.10 0.38 0.38 0.73
1.00 1.20 1.20 2.30
10.00 3.80 3.80 7.30
100.00 12.00 12.00 23.00
For transmitters rated at a maximum output power not listed above, the recommended separation distance
(d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufac-
turer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp-
tion and reflection from structures, objects, and people.
11.11 Essential Performance

Per EN 60601-1, essential performance for the INVOS™ patient monitor includes the
detection and reporting of changes in rSO2 values of ≥ 20% from baseline.

A Clinical Studies
A.1 Overview
This appendix provides information on clinical studies using the INVOS™ regional saturation
patient monitoring system. A reference bibliography containing additional clinical studies is
available on Medtronic’s website (www.medtronic.com) or by contacting Medtronic or a local
Medtronic representative. See Technical Services, page 1-7.
An adult volunteer study was performed comparing the regional oxygen saturation (rSO2) from
the system to blood sample analysis in 20 volunteers (hypoxia study). No adverse events
attributable to the system were reported during the study.
• Hypoxia Study, page A-1
• Interventional Studies, page A-3
• Validation Studies, page A-4
A.2 Hypoxia Study

The hypoxia study compared the rSO2 as reported by the system to the “field” saturation (fSO2)
calculated from arterial and jugular venous blood oxygen saturation measurements at five
levels of oxygen saturation and two levels of inspired CO2. Based on the assumption that
cerebral tissue contains arterial and venous blood in a 1:3 ratio, fSO2 was calculated as:
fSO2 = (0.25 X SarterialO2) + (0.75 X Sjugular veinO2)
The 20 volunteers included: 19 with light and 1 with dark skin; 12 males and 8 females; age 20
to 36 years, with a median of 25 years. One data point was excluded from analysis due to delays
in blood sampling caused by catheter problems.
Methods: Blood samples were obtained from the right internal jugular bulb and the radial
artery. A SomaSensor™ sensor was placed on the right forehead. Subjects breathed controlled
gas mixtures in a predefined sequence of 4- and 5- minute intervals to attain five levels of arterial
O2 saturation (74% to 100%). This sequence was performed twice at two different CO2 levels (4-
7 mmHg increase) intended to raise cerebral blood flow and evaluate the ability of the system
to reject noncerebral data.
A-1
Clinical Studies
Results
Figure A-1. Accuracy rSO2 and fSO2, 20 Subjects
Accuracy 96 and 97 data; last 20 subjects; 189 data points. y=0.9026x+4.3235;

R2=0.729; bias=2.51; standard deviation=5.23.
Table A-1. Performance Characteristics: Accuracy Bias, Error (SD), RMSD, and Correlation (R2) for rSO2 and fSO2, 20 Subjects
Individual subjects (N=20) Range Pooled (N=189)

mean data points
Accuracy Bias (%)1 2.56 –6.47 to +11.78 2.51
Error (SD) (%)1 2.08 0.85 to 4.22 5.23
RMSD 1 5.11 2.15 to 12.03 5.79
Correlation (R2) 1 0.946 0.823 to 0.990 0.729

1. Less subject 206
One subject had a bias value of 37.2%, which corresponded with a very low signal quality index
number (SQI=1). The remaining 41 subjects had SQIs that started at 10 and remained greater than
four throughout the study.
Subject 206’s absolute bias data was excluded from the analysis due to the low signal quality, but
the trend data was left in as trending is not dependent on SQI.
A-2 Operator’s Manual

Interventional Studies
Figure A-2. Trend rSO2 and fSO2, 20 Subjects
Trend 96 and 97 data; last 20 subjects; 179 data points. y=0.9133x–0.1755;

R2=0.958; bias=0.26; standard deviation=2.9.
Table A-2. Trend Bias, Error (SD), and Correlation (R2) for ΔrSO2 and ΔfSO2, 20 subjects
Pooled (N=179) data points
Trend Bias (%) 0.26
Error (SD) (%) 2.90
Correlation (R2) 0.958
A.3 Interventional Studies

In controlled studies of carotid endarterectomy (references 1-3), changes in the rSO2 of 12-20
points (absolute) or 20% to 30% (relative) correlated with changes in the patient’s neurological
status. In these studies, as well as in other interventional studies of general and cardiac surgery
patients (references 4-10), rSO2 values less than 50 were associated with higher probabilities of a
poor outcome.
1. Cho H, Nemoto EM, Yonas H, Balzer J: Cerebral monitoring by oximetry And Somatosensory Evoked
Potentials (SSEP) during Carotid Endarterectomy. J Neurosurg, 89:533-38, 1998.
2. Roberts KW, Crnkowic AP, Linneman LJ: Near infrared spectroscopy detects critical cerebral hypoxia
during carotid endarterectomy in awake patients. Anesthesiology 1998;89(3A):A934.
Operator’s Manual A-3

Clinical Studies
3. Samra S, Dy E, Welch K, Dorje P, Zelenock G, Stanley J: Evaluation of a cerebral oximeter as a monitor of

cerebral ischemia during carotid endarterectomy. Anesthesiology 2000;93:964-70.
4. Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S.
Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study.
Anesth Analg. 2007 Jan;104(1):51-8.
5. Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Montanini S. Monitoring cerebral oxygen

saturation in elderly patients undergoing general abdominal surgery: a prospective cohort study. Eur
J Anaesthesiol. 2006 Jul 7;:1-7 [Epub ahead of print].
6. Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G.

Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal
surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-7.
7. Edmonds HL Jr, Ganzel BL, Austin EH 3rd. Cerebral oximetry for cardiac and vascular surgery. Semin
Cardiothorac Vasc Anesth. 2004;8:147-66.
8. Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using
noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart
Surgery Forum 2004;7(5):#2004-1062.
9. Murkin JM, Iglesias I, Bainbridge D, Adams S, Schaefer B, Irwin B, Fox S. Monitoring cerebral oxygen
saturation significantly decreases major organ morbidity in CABG patients: A randomized blinded
study. The Heart Surgery Forum 2004;7(6):515.
10. Yao FSF, Tseng CCA, Ho CYA, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early
postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac
Vasc Anesth 2004;18(5):552-558.
A.4 Validation Studies

Validation studies for the system include, but are not limited to, the following references:
1. Kim MB, Ward DS, Cartwright CR, Kolano J, Chlebowski S, Henson LC. Estimation of jugular venous O2
saturation from cerebral oximetry or arterial O2 saturation during isocapnic hypoxia. J Clin Monit
Comput. 2000;16(3):191-9.
2. Kolb JC, Ainslie PN, Ide K, Poulin MJ. Effects of five consecutive nocturnal hypoxic exposures on the
cerebrovascular responses to acute hypoxia and hypercapnia in humans. J Appl Physiol. 2004
May;96(5):1745-54. Epub 2004 Jan 16.
A-4 Operator’s Manual

Part No. PT00097962 Rev B 2019-01
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.
© 2016 Medtronic. All rights reserved.
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15 Hampshire Street, Mansfield, MA 02048 USA.
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Operator’s Manual

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

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

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

Operator’s Manual iii

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

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

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

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

8 Alarms and Troubleshooting

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

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

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

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

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

Operator’s Manual vii

• 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

1.3 Safety Information

1.3.1 Safety Symbols

Table 1-1. Safety Symbol Definitions

1.3.2 Explosion, Shock, and Toxicity Hazards

1-2 Operator’s Manual

processing equipment, the latest IEC/EN 60601-1 standard for electromedical

1.3.3 Patient Monitoring and Safety

Operator’s Manual 1-3

1-4 Operator’s Manual

to rain. Do not immerse in water, solvents, or cleaning solutions, since the

1.3.5 Sensors, Cables, and Other Accessories

1.3.6 Electromagnetic Interference

Operator’s Manual 1-5

1-6 Operator’s Manual

1.4 Obtaining Technical Assistance

1.4.1 Technical Services

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

5870 Stoneridge Drive, Suite 6

When calling Medtronic or a local Medtronic representative, have the monitoring

Operator’s Manual 1-7

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

1.4.2 Related Documents

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

• INVOS™ Patient Monitor Service Manual — Provides information to authorized tech-

1-8 Operator’s Manual

1.5 Warranty Information

Operator’s Manual 1-9

Page Left Intentionally Blank

1-10 Operator’s Manual

• Indications for Use, page 2-2

• Product Views, page 2-3

• Product and Carton Label Symbols, page 2-13

2.2 Product Description

• 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™ rSO2 sensors

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

Monitoring system features include: